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August/September 2012 Vol. 18, No. 4
FEATURES 52 Cover Story

COLUMNS
12
Focus: Allergens Training Is a Key Component in Serving Patrons with Food Allergies
By Betsy Craig
The State of Food Safety: Regulation, Collaboration and the Advancement of a Globally Safe Food Supply
By Jorge A. Hernandez
16
62 Category: Eggs

Focus: Allergens Allergen- and Gluten-Sensitive Consumers: What Manufacturers Should Know
Making the Case for Caging: Improvements in Egg Safety and Animal Welfare
By Patricia A. Curtis, Ph.D., and Jacqueline Kochak
By Julie Trone
20
International Food Safety Planet versus Profit

By Hein Timmerman, M.Sc., M.B.A.
70 ReformulatiON

The Pitfalls of Product Reformulation and How to Avoid Them

By Evangelia Komitopoulou, Ph.D., and Paul A. Gibbs, Ph.D.
24 Regulatory Report CORE: FDA Foodborne Illness Response Network

By Douglas Karas
28
Meat and Poultry

76 Spotlight:
Sanitation Pests: Everyday Threats to the Human Food Supply

By Jim Fredericks, Ph.D. and Missy Henriksen
Building a Solid Foundation in Meat Processing and Preparation

By Anne Rogan, Ph.D., R.D., C.D.N., and Eric Shelley
30 Process Control Supplier Management: Six Steps to Selecting the Right Supplier
By Bradd Eldridge
DEPARTMENTS
6 Editors Letter 8 News Bites Editorial Advisory Board
Daniel W. Bena PepsiCo Beverages International Reginald W. Bennett CFSAN, U.S. FDA Robert E. Brackett, Ph.D. National Center for Food Safety and Technology John N. Butts, Ph.D. Land OFrost Brian Campbell Kroger Manufacturing Larry Cohen Saputo Cheese U.S.A. Michael M. Cramer Windsor Foods 4
32
79 Product Showcase 83 Advertisers Index
Beth Ann Crozier-Dodson, Ph.D. Chestnut Labs Jonathan W. DeVries, Ph.D. General Mills/Medallion Labs William Fisher Institute of Food Technologists Russell Flowers, Ph.D. Silliker, Inc. Veny Gapud Fieldale Farms Kathy Gombas CFSAN, U.S. FDA Jim Gorny, Ph.D. CFSAN, U.S. FDA Donald J. Graham Graham Sanitary Design Consulting
Packaging Trends in Food Packaging: Borrowed Expertise

By Julie Ackerman
Robert Powitz, Ph.D., M.P.H., R.S. R.W. Powitz & Associates Scott M. Russell, Ph.D. University of Georgia Thomas M. Sauer Wells Enterprises Richard F. Stier Consulting Food Scientist Darryl Sullivan Covance Laboratories John G. Surak, Ph.D. Surak and Associates Alexandra Veiga, Ph.D. ITQB-UNL and EFFoST Don L. Zink, Ph.D. CFSAN, U.S. FDA Food Safety Magazine
Paul A. Hall, Ph.D. Flying Food Group Margaret Hardin, Ph.D. IEH Laboratories & Consulting Group Larry Keener International Product Safety Consultants Huub L.M. Lelieveld Global Harmonization Initiative Ann Marie McNamara, Ph.D. Jack in the Box, Inc. Martin Mitchell Certified Laboratories/ Refrigerated Foods Association Doug Peariso Contemporary Process Solutions LLC
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Editors Letter
ood agencies and Congress have been busy these days. First we have the Farm Bill, just approved by the House Committee on Agriculture, which gives farmers new ways to protect themselves from bad weather and poor prices, and slices about 2 percent off the $80 billion the government spends every year on food stamps. Talk about a political hot potato, especially here in Massachusetts, where my U.S. representative was scrambling to avoid these cuts in food stamps. This legislation now shifts the focus to the full House as Congress seeks to come up with a consensus bill before the current farm bill expires at the end of September. Then we have proposed egg-production legislation, which seeks to set a uniform national standard for the treatment of egg-laying hens, ensuring that egg producers are not blocked from selling across state lines due to differing state standards. Led by Californias Proposition 2, passed in 2008, which requires chicken farmers to give their egg-laying birds enough room to stand and spread their wings, the proposed law would codify an agreement between the United Egg Producers and the Humane Society on how egg-laying hens should be treated and how eggs should be labeled. Finally, we have the U.S. Department of Agriculture (USDA) Food Safety and Inspection Services proposed rule, Modernization of Poultry Slaughter Inspection, that was published in the Federal Register on January 27, 2012, which would allow production lines to move faster, while the government would cut the number of line inspectors eyeing chicken bodies for defects before the carcasses are packaged for consumption. As early as the late 1990s, there was an identified need for fundamental changes in how poultry inspections are performed, particularly with regard to a more thorough adoption of scientifically based inspections. However, food industry experts have serious concerns about the lack of detail in the proposed legislation. Clarification, especially on topics of implementation costs, training, record-keeping requirements and facility retrofitting issues, is needed before its successful adoption. USDA is asked to adhere strictly to Hazard Analysis and Critical Control Points principles and enable industry establishments to make their own processing and implementation decisions to guarantee that food safety is best ensured in each individual situation. Lets all hope that best practices and the desire for overall food safety drive food-related legislation in the weeks and months ahead. Best Regards,
CEO, The Target Group Inc. Don Meeker Publisher Stacy Atchison Editorial Director Barbara VanRenterghem, Ph.D. Art Director/Production Craig Van Wechel Circulation Manager Andrea Karges Administrative Manager Allison Demmert-Poland
The Incredible Shrinking Woman Bobby Meeker
Publishing Office 1945 W. Mountain St. Glendale, CA 91201 Main (818) 842-4777 Fax (818) 955-9504 customerservice@foodsafetymagazine.com Editorial Office 1945 W. Mountain St. Glendale, CA 91201 Phone (508) 210-3149 Fax (508) 210-3139 barbara@foodsafetymagazine.com Production Office 1113 Ellis Street Ft. Collins, CO80524 Phone (970) 484-4488 craig@foodsafetymagazine.com
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Bobby Meeker (818) 842-2829 bobby@foodsafetymagazine.com Adam Haas (321) 804-4319 adam@foodsafetymagazine.com
Barbara VanRenterghem, Ph.D. Editorial Director

6
Food Safety Magazine (ISSN 1084-5984) is published bimonthly by The Target Group Inc., 1945 W. Mountain St., Glendale, CA 91201; (818) 842-4777; Fax (818) 769-2939; E-mail info@foodsafetymagazine.com. Periodicals Postage Rate paid at Glendale, CA, and additional mailing offices. Subscriptions: Free to qualified subscribers as defined on the subscription card; $85.00 per year for nonqualified subscribers. Back Issues: $10.00 per copy, prepaid. Change of Address: Notices should be sent promptly; provide old mailing label as well as new address. Allow two months for change. Editorial Contributions: Unsolicited manuscripts should be submitted to: Food Safety Magazine, 1945 W. Mountain St., Glendale, CA 91201. Notice Every precaution is taken to ensure accuracy of content; however, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein. Postmaster: Send address changes to Food Safety Magazine, 1945 W. Mountain St., Glendale, CA 91201. 2012 by The Target Group Inc. All rights reserved. Reproduction in whole or part without written permission is strictly prohibited. The publishers do not warrant, either expressly or by implication, the factual accuracy of the articles or descriptions herein, nor do they so warrant any views or opinions offered by the authors of said articles and descriptions.
Food Safety Magazine
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News Bites
Egg Producers Subject to FDAs Egg DuPont Sponsors Global Food Security Index Developed by EIU Safety Rule Must Now Comply
As of July 9, 2012, shell-egg producers with at least 3,000 but fewer than 50,000 laying hens must comply with the U.S. Food and Drug Administration (FDA)s Egg Safety Rule. The Egg Safety Rule, finalized in 2009 and designed to prevent thousands of illnesses and dozens of deaths each year from consumption of eggs contaminated with Salmonella Enteritidis (SE), requires that shell-egg producers put measures in place to prevent SE from contaminating shell eggs during their production, storage and transport. The requirements for industry compliance with the regulations were phased in over a 3-year period based on the number of laying hens in each operation. FDA has published Guidance for Industry regarding implementation of the Egg Safety Rule, as well as draft guidance (which FDA intends to finalize) that addresses questions the agency has received about the final rule since its publication. FDA also intends to publish draft guidance for producers who provide their laying hens with outdoor access.
DuPont Chair and Chief Executive Officer Ellen Kullman and Executive Vice President Jim Borel each announced the launch of the Economist Intelligence Unit (EIU) Global Food Security Index. Created in collaboration with the EIU, this interactive, first-of-its-kind tool brings critical information to the public discussion on food security. DuPont is the exclusive sponsor of the index. The index considers the core issues of food affordability, availability, access and quality across a set of 105 countries. It is a dynamic quantitative and qualitative scoring model, constructed from 25 unique indicators, which measures these drivers of food security across both developing and developed countries. The index is accessible at foodsecurityindex.eiu.com/. Since DuPont announced its food security goals in February, there has been a steady buzz of conversation around food security globally. Work is underway to align the right people across organizations, countries and industries to make connections that will deliver science-powered innovations to address the challenge of feeding and nourishing an ever-growing population.
Charm Sciences Inc. is pleased to announce that the ROSA FAST Aflatoxin Quantitative Test Kit, a quantitative lateral flow test, has received approval from the United States Department of Agriculture (USDA)s Grain Inspection, Packers and Stockyards Administration (GIPSA) for the detection of aflatoxin in feed and grain. The kit provides test results in 3 minutes and is approved for over 20 commodities. It is an immunoreceptor assay utilizing ROSA (rapid one-step assay) lateral flow technology. The diluted extract is applied to each test strip, incubated and read on the ROSA-M Reader for quantitative results.
8
USDA/GIPSA Approves Charm Sciences ROSA FAST Aflatoxin Test
USDA and Ad Council Plan Food Safety PSAs
The U.S. Department of Agriculture (USDA) has collaborated with JWT New York and the Ad Council to develop Food Safe Families, an outdoor public service announcement (PSA) advertising initiative that will highlight safe food preparation and handling techniques, as well as foodborne-disease risks. The campaign, which aims to fight food poisoning, will also have an integrated social media program and television, print, radio and online advertising in English and Spanish. The pro bono campaign consists of public service announcements on billboards, bus shelters and other out-of-home locations nationwide, as well as video spots running on Walmarts Checkout TV Network.
3M Obtains AFNOR Approval for Petrifilm Aqua Coliform Count Plate
3M Food Safety has announced that its 3M Petrifilm Aqua Coliform Count Plate has received NF validation from France-based Association Franaise de Normalisation (AFNOR) for its ability to detect and enumerate colonies of Escherichia coli and coliform bacteria in bottled water samples. Validated against ISO 9308-1, the AFNOR certification confirmed that the microbiological analysis of 3Ms indicator technology performs as well as or better than conventional and more time-consuming reference methods. The 3M Petrifilm Aqua Plate technology was introduced globally in March 2011, offering bottled water processors a microbial testing tool that delivers simplicity, consistent performance, minimal storage and enhanced productivity compared with reference methods that use bulkier media pads, disposable filter funnels and agar petri dishes.
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News Bites
GFSI and TAFS Forum Join Forces for Collaboration People & Places
Richard F. Stier, food scientist consultant, has received the 2012 Bor S. Luh Award Stier for his international contributions in food science, focusing on food safety, quality and sanitation. Beth Ann Crozier-Dodson, Ph.D., has joined Chestnut Labs as the director of Crozier-Dodson technical services. Saputo Cheese, USA Inc. has named Larry Cohen the companys new food safety director. Paul A. Hall, Ph.D., has joined the Flying Food Group as vice president of food Hall safety & quality assurance. EAS Consulting Group has announced that Stephen F. Sundlof, D.V.M., Ph.D., has joined the company as an expert consultant. NSF International has appointed Tom Chestnut as vice president of the companys global food safety and quality division. La Terra Fina has announced John Harrington as the new director of marketing and Harrington Cindy Hess and Steve Ihme as new directors of sales. Millennium LifeSciences Inc. Culture Media Concepts has announced Jingkun Li Li, Ph.D., as their senior scientific advisor. Food Safety Net Services has announced the addition of Amit Morey, Ph.D., to the science and technical team. Redd Remedies has recently brought on Rose Cloud as their national sales manager. YottaMark Inc., provider of the HarvestMark fresh food traceability and supply chain insights platform, has named Reggie Griffin to its advisory board. Dietmar Eiden has been named the new head of division in trade fair management Eiden at Koelnmesse. Members of the International Association for Food Protection recently elected Alejandro Mazzotta, Ph.D., to the executive board as secretary. DDW has announced that Daniel Castillo has joined the company as sales Castillo director, Americas. Linda M. Doherty, president and CEO of the New Jersey Food Council, received the Food Marketing Institute Donald H. MacManus Association Executive Award in recognition of her outstanding leadership and accomplishments in the food distribution industry. Stephanie Lopez has been named vice president of food safety education at AIB Lopez International. Eriez has appointed John Blicha to the newly created position of marketing commuBlicha nications manager.
The Global Food Safety Initiative (GFSI) and the Switzerlandbased TAFS (Trust in Animals & Food Safety) forum have announced their future collaboration on animal health and food safety issues. The TAFS forum and GFSI recently signed a memorandum of understanding (MoU) to support their joint efforts for the continuous improvement of food safety throughout the global food supply chain. Both the TAFS forum and GFSI consider animal health a prerequisite for food safety and will team up to address these issues together, complementing each others activities. Whereas GFSI acts mostly in the domain of risk management by benchmarking and recognizing existing food safety management strategies, the TAFS forum focuses on risk assessment and risk communication in the field of livestock diseases that are transmissible to humans through food and other pathways. The TAFS forum and GFSI will work together along with other stakeholders to identify key areas for future collaboration. Further projects of mutual interest will be defined to develop better interaction between risk assessment and risk management within existing food safety management systems. Both organizations strongly believe that coordinated efforts and greater collaboration will contribute to achieving their common goal of improved consumer trust in food safety.
BizTracks
Bemis Selects Thin Film Electronics to Develop Intelligent Packaging Platform
Thin Film Electronics ASA, developer of printed electronics, and Bemis Company Inc., a Fortune 500 supplier of flexible packaging and pressure-sensitive materials, have announced an agreement to develop a flexible sensing platform for the packaging market. The result will be a new category of packaging that can collect and wirelessly communicate sensor information for use by leading food, consumer products and healthcare companies worldwide.
J. P. Selecta Forms Partnership with Globe Scientific

The J. P. Selecta line of high-end nutritional and water analysis scientific equipment is now available in North America through a partnership with Globe Scientific Inc. The nutritional line includes Kjeldahl digestion unit organic nitrogen determination, steam distillation of protein, extraction for determination of cellulose and fiber, cold extraction units and wine (alcohol) distillation units. A complete line of routine laboratory equipment is also available.
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Focus on ALLERGENS
By Betsy Craig
Training Is a Key Component in Serving Patrons with Food Allergies

Allergen control in foodservice is essential
Armed with that knowledge, servers or managers can confidently respond when diners ask if a dish contains a specific ingredient. We are definitely getting more questions than we did 5 or 6 years ago, says Mark Herman, CEO of Dions, which serves pizzas, salads and sandwiches in 17 quick-serve locations in New Mexico and Texas. People are more aware, and they have more access to information. They want to know more.
From Knowledge to Action

Knowledge may be power, but there are two more steps beyond menu analysis an operator must take to safely accommodate diners with food sensitivities. The first affects the back of the house; the second involves the entire operation, from owner to bussers. Cross-contamination of dishes prepared without offending ingredients can occur anywhere in the production process, through shared cutting boards or utensils or grease particles flying from grills. Thats why any kitchen that offers special dishes to sensitive diners must develop specific protocols to keep the meal away from triggering ingredients all the way from cooler to table (see Tips for Foodservice: Setting Up a GlutenFree Kitchen, p. 14). The recent dust-up over Dominos pizza it calls gluten-free illustrates the problem. While the chain spent lots of money developingand marketinga crust made without wheat flour, it did nothing to ensure the non-wheat crust would not pick up gluten from the other pies in the kitchen. In fact, by sharing baking benches and ovens with wheat crusts and not following proper food allergen protocols, Dominos more or less guaranteed that what started out as gluten-free would reach the carryout box as only gluten-not-so-much. At least the stores now post a disclaimer to the effect that its gluten-free pizza is not suitable
hen most people think of food safety, they think of keeping the mayonnaise cool or using proper handwashing techniques. While these practices protect against foodborne pathogens, theres another dimension to serving customers meals that wont send them to the emergency room (ER) for dessert. Commercial foodservice operations increasingly need to be aware of patrons with food allergies and intolerances. Approximately 9 million American adults (4% of the population over 18) and 6 million children (8% of those under 18) are allergic to one or more foods. The numbers rose about 18% between 1997 and 2007, the most recent year for which figures are available from the U.S. Centers for Disease Control and Prevention (CDC). Reactions to triggering foods can be severethe CDC reported that food allergies account for nearly a quartermillion ER visits every year and are the most common causes of anaphylaxis outside the hospital setting. The most common food allergens are milk, wheat, soy, fish, shellfish, peanuts, tree nuts and eggs. Think about all the places on any menu these items could lurk, not just as featured items but also in condiments or the like. Was that salad dressing finished with eggs for a better consistency? Or maybe a dash of soy sauce makes the beef gravy more flavorful? It takes a complete breakdown of every ingredient in every dish to know exactly what a kitchen is serving its customers.
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for those who need to follow a glutenfree diet for health reasons. Because of how we produce food in our kitchens, its impossible to offer a 100 percent gluten-free product, Herman says. Id rather not have it on the menu than to make someone sick. Dions also doesnt offer options such as dairy-free cheese because of limited demand, but if diners want to bring in special ingredients, the kitchen would be happy to use them on a pie or in a sub. Herman sends all his managers to ServSafe training and all staff to basic food-handling classes. In April, he sent about 40 managers and staff through our Kitchens with Confidence AllerTrain training. Now he plans to add the food allergy training to the other educational pieces for everyone from order takers to managers. The webinar was the kickoff to see where we have to get better at what we do, Herman says. What we learned was that we need to have clear processes in place that are followed at every step. This is the second step to keeping your patrons out of the ER. Everyone on staff should be aware of any diner with an allergy or intolerance to any food. If possible, the host should make a note of it when a reservation is made and/or flag the party when they are seated. Servers should always listen to and respect the diners request and answer truthfully about whats in a disheven if theyre otherwise upselling the special macadamia-crusted prawns in creamy ponzu
(continued on page 82)
Tips for Foodservice: Setting Up a Gluten-Free Kitchen

Just because a label says wheat-free, it doesnt mean its gluten-free. Since there are no uniform labeling standards, different manufacturers use different symbols. As a result, wheat-and gluten-free symbols can look similar. Additionally, products labeled wheat-free may still contain rye- or barley-based ingredients that are not gluten-free. When choosing glutenfree products, it is of the utmost importance to read the label carefully for the words gluten-free. In a perfect world, gluten-free food production has a dedicated facility. Since thats not always possible, a common facility or foodservice operation should use the following: Separate food preparation zones and storage areas Accurately labeled containers that are tightly sealed Separate utensils for food preparation and serving Clean hands, fresh gloves and clothing Controlled airflow that minimizes airborne particles landing on glutenfree food Thorough cleaning between runs or sessions with wet-cleaning systems An allotment of at least 24 hours between regular and gluten-free food preparation to allow flour particles to settle and then be cleaned away As cross-contamination of gluten-free foods can cause severe reactions in those with celiac disease, its important to note the most common sources of cross-contact: Shared use of utensils, containers, appliances or baking equipment Airborne particles from wheat, rye, barley or untested oat flour Incomplete cleaning of utensils, equipment or surfaces between runs Contaminated gloves or clothing in gluten-free preparation areas Unsafe or careless food handling by employees or diners To avoid such cross-contact, it is critical for foodservice personnel to ensure that: Buffet tables have clearly marked, separate areas for gluten-free food Each food has a separate serving bowl with a clearly marked serving utensil Dishes are arranged so that regular food doesnt spill, splatter or fall onto gluten-free food (e.g., making sure containers of regular food are not adjacent to gluten-free food) Gluten-free food is served on plates, bowls or napkins of different colors (e.g., bread baskets with gluten-free bread have a differentcolored napkin than baskets containing regular bread) Gluten-free food is shaped differently (e.g., gluten-free cake is served in rounds while regular cake is served in squares) Some institutions serve the occasional gluten-free guest by purchasing ready-made foods or baked goods from approved gluten-free suppliers. Others keep small-scale gluten-free mixes on hand to bake as needed. Establishments serving larger groups of guests requiring gluten-free foods on a regular basis may bake from scratch using gluten-free bulk ingredients and their own in-house recipes or recipes adapted from gluten-free cookbooks. Your particular organization and the needs of your guests will determine which method you choose. Keep in mind that the following grains are safe for a gluten-free diet: amaranth, buckwheat, corn, millet, oats (tested gluten-free), quinoa, rice, sorghum and teff. All wheat products, including bulgur, durum, emmer, farro, Kamut grain, semolina and spelt, in addition to barley, rye, triticale and untested oats, should be avoided. When purchasing gluten-free ingredients, make sure they are tightly sealed and clearly labeled in containers. Whatever the type or size of your foodservice establishment, it is critical that one person be designated to lead the gluten-free effort. To ensure gluten-free food safety, all staff must be thoroughly trained. Turnover of personnel, menu revisions, ingredient/supplier changes and differences in labeling necessitate ongoing and continual training. Clear guidelines and expectations and regular updates are essential. The words you use to describe your gluten-free offerings to customers must also be reviewed for any legal implications. Finally, use the 4 Rs to make sure the gluten-free meal is as safe as it is enjoyable: Refer the food allergy concern or special request to the chef, manager or designated individual Review the food allergy concern or special request with the guest and check ingredient labels Remember to check the preparation method procedures for potential cross-contamination Respond to the guest and communicate your findings, then let the guest make an informed decision Armed with accurate information and the proper training, all foodservice institutions can successfully serve their gluten-free customers safe food. Bobs Red Mill, Milwaukie, OR
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Focus on ALLERGENS
By Julie Trone
Allergen- and GlutenSensitive Consumers: What Manufacturers Should Know

Controlling allergens and gluten is a key consumer demand
similar dietary needs regarding the safety of a food product. This global community of consumers is well connected to each other through social media. They are a vast group who support, commiserate with and follow each other. When an allergic reaction or illness occurs due to undeclared allergens or gluten, the news often spreads like a virus. The offending brand becomes a villain that is ostracized from an entire community. According to the U.S. Centers for Disease Control and Prevention, the number of Americans with food allergies, celiac disease and other food-related intolerances has steadily risen over a short period of time. The following statistics illustrate how prevalently these diseases affect the U.S. population: From 2004 to 2006, there were approximately 9,500 hospital discharges per year with a diagnosis related to golf instructor once told me that to play confood allergy among children under sistent golf, I needed to focus on the process age 18.3 first, not the result. For a novice golfer, this was the perfect time to hear this tidbit of The American Academy of Allergy, wisdom. It is also representative of my life as Asthma and Immunology reports a parent of a son with severe, multiple food allergies. The that it is estimated that the number process of raising him with dietary restrictions involves of cases of anaphylaxis from foods in diligence, awareness, research, teamwork and incredible the U.S. increased from 21,000 per trust in the food industry. The result is a healthier life. year in 1999 to 51,000 per year in 2008, based on long-term population Understanding Consumers with Allergies studies of anaphylaxis from the Mayo Clinic in Minnesota.4 Gluten-free food sales in the U.S. have already reached $2.6 billion and, according to a survey by Packaged Facts, More than 2 million people in the the gluten-free market will exceed $5 billion by 2015.1 United States have celiac disease.5 The global food allergy and intolerance products market Gluten-reactive patients account for is expected to surpass $26.5 billion by 2017, according to roughly 10 percent of the general a report released by Global Industry Analysts Inc.2 The population.6 growth projections underscore the need for attention to Clearly, these statistics suggest a conproviding quality safe food products to consumers with sumer market that requires food that food allergies or intolerances. does not make them sick or die when Consumers who must avoid specific foods become ingested. Absolutely no contamination very informed shoppers. This is a population of parby allergens or gluten is their foremost ents, teens and children who learn to be allergen, gluten criteria for safe consumption. or food enzyme detectives. Their shopping behavior includes reading labels each and every time before purAccommodating Food Sensitivities chase, speaking with customer service representatives The increase in food-related disease about shared lines, processing schedules and crossis widely responsible for the rise in concontamination and enlisting help from others who have sumer demand for safer food products
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Focus on ALLERGENS
in the U.S. With the enactment of the Food Safety Modernization Act (FSMA), the food industry is receiving rapt attention by, in part, implementing more stringent regulations and more thorough inspections, particularly at the food processing stage. What is not on par with this hefty legislation is the quality assurance that food is not contaminated by allergens or gluten along the entire supply chain. This assurance is especially inconsistent at the growing, harvesting, storing and transport stages with various allergens, such as grains, soy and corn. Today, there is heightened awareness and improved sanitization control during manufacturing through Hazard Analysis and Critical Control Points systems that are implemented properly. In addition, many large manufacturers have been leading the pack in quality control of allergen and gluten contamination. Midsize and smaller manufacturers have not been found to be consistent in reducing exposure to allergens and gluten in a variety of ways, according to the U.S. Department of Health and Human Services in their report on labeling practices.7 In recent findings during a case study of the cookie industry, Steven Atkins and Marcia Hagen reported, poor training accounts for the most frequent human error with adding wrong ingredients.8 Evolving from FSMA is a requirement for manufacturers to have an allergen-control plan. The framework of this plan supports the development of an internal process for detecting and preventing cross-contamination by allergens or gluten. According to Steven Taylor, Ph.D., at the University of Nebraska Food Allergy Research and Resource Program, the use of the allergencontrol plan developed at the university in larger manufacturing companies is a mainstream practice. The use of enzyme-linked immunosorbent assay testing for detection of allergens and gluten is also part of this framework, as is the need for manufacturers to know whether an ingredient or raw material has been contaminated so labeling can be accurate.
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Reporting of Allergen and Gluten Contamination: The Reality

The story here begins at the production site where food is harvested and continues with storage, transportation and processing. The law that requires labeling of the top eight most common allergens, the Food Allergen Labeling and Consumer Protection Act (FALCPA), excludes raw agricultural commodities (FALCPA section 203). In 2006, after FALCPA went into effect, a report was released by the secretary of the Department of Health and Human Services that indicated when receiving raw materials for products, 55% of the facilities that used allergenic food as ingredients identified ingredients as allergens or segregated these ingredients, or both. Smaller facilities were less likely than larger facilities to identify or segregate allergenic ingredients.7 As a result, consumers who rely on accurate labeling and product disclaimers to make informed decisions about the safety of a product are driven to lobby for new regulations that require better standards for reporting, identifying and segregating allergens and gluten at every level of food production and distribution.
food recalls initiated in the quarter.9 This report continues, stating, Recalls due to undeclared allergens reached a new high in the fourth quarter, surpassing levels recorded in at least five quarters. A continued increase in the number of allergen-related recalls may intensify pressure on the industry to make disclaimers mandatory.
Recalls Damage Brand Integrity

Recalls are an expensive testament to the need for better control of allergen and gluten exposure as well as for better reporting of contamination. Once a recall is publicized, the community of those with food allergies and gluten intolerances chat about it on social media engines worldwide. With the use of social media, bad information spreads quickly and has a long residual effect. Information about recalls remains constant on a variety of websites; yet, how the manufacturer corrects the problem remains a mystery to the public. The fear of illness or death from potential consumption and lack of information about correcting the problem degrades the reputation of the brand. The consequence is that brand integrity declines, carrying with it decreased loyalty and less demand. Under these circumstances, it is difficult for a manufacturer to improve the integrity of the brand and climb out of debt. As a case in point, 5 or 6 years ago, a story about an allergic reaction after someone ate a Snyders pretzel was told via an online food allergy support group. The pretzel apparently had peanut contamination. The group had a large following throughout the U.S., and the many parents who heard this story avoided the entire product line. This story has continued to affect the purchasing behavior
...the number of
Americans with food
allergies, celiac disease and other food-related intolerances has
steadily risen over a short period of time.
The Use of Disclaimers: Why Is It Voluntary?

The use of disclaimers on packaging is voluntary. Even with a disclaimer, the consumer oftentimes is unsure about the safety of the product. This is a valid concern. Recall events due to undeclared allergens have multiplied since FALCPA went into effect, validating this concern. A recent report by Stericycle found undeclared allergens or other allergen concerns remained the primary cause of recalls during the fourth quarter, accounting for more than one third of
NIR , Kje l Falli dahl, Du ng N mas , umb er
Sample Preparation of Food and Feed
Ultra Centrifugal Mill ZM 200
Knife Mill GRINDOMIX GM 200
Cyclone Mill TWISTER
For optimum quality control

Application examples Raw material Wheat Corn Hay/straw Feeds Pig food pellets Pet food pellets Fish food pellets Dry food Rice Cereals Peanuts Almonds Soy beans Sunower seed Cookies Moist food Tomatoes Cheese Sausages Cooked pasta + highly suitable 0 suitable TWISTER ZM 200 GM 200 / GM 300
+ o + + + + + + + o
+ + + + + + + + o o + +
o + o o o o o + + o o + + + + +
Within the RETSCH range of mills and grinders there is a specialist for every application. But what they have in common is that they produce a perfectly homogeneous, unaltered and uncontaminated sample so that the subsequent analysis is always trustworthy and meaningful. If you require professional solutions that combine high performance, ease of use, a maximum of operational safety and a long lifetime, then RETSCHs equipment is your only choice!
Ideal for forage, feeds and grains
CYCLONE MILL TWISTER

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www.retsch.com/twister
not suitable
WET CHEMICAL AND ELEMENT ANALYSES RETSCH laboratory mills are suitable for sample preparation not only to NIR analysis but a variety of analytical methods. Achievable grind sizes of approximately 500 microns are ideal for protein analysis according to Kjeldahl and Dumas. The same is true for the determination of falling numbers. The grind size is also suitable for the determination of fat and organic contaminants through extraction, resp. of inorganic contaminants through digestion.
NEW
Cyclone Mill TWISTER
SAMPLE PREPARATION TO NIR ANALYSIS

Near Infrared Spectroscopy is the most important analysis method for the determination of protein content, moisture, fat and ash in feeds and forage. The advantage over classical methods such as Kjeldahl is the simultaneous determination of several parameters. Moreover, NIR spectroscopy is a quick method which neither requires consumables nor reagents. Therefore it is used whenever high sample throughput and great exibility are required. The identication and qualication of raw materials as well as the quantitative analysis of convenience products can be carried out within seconds to guarantee highest product quality and safety. A much discussed issue related to NIR analysis is the necessity of sample preparation. Users often face the problem of having to decide whether sample preparation is required or not. Sample preparation to NIR does not require digestion or extraction, it is mainly about size reduction of the sample material. This involves two aspects:
ASH
1. Homogenizing the sample 2. Achieving the required grind size
Whereas an inhomogeneous sample leads to systematic errors in the subsequent analysis, a sample which is too coarse causes statistical errors (see example on next page).
MOISTURE FIBERS FAT
PROTEIN
Ideal for samples high in water and oil content
Fine grinding of grains, oilseeds, corn, animal feed pellets, spices, dried pasta and plants, tea, cocoa and raw coffee
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EXAMPLE: ANALYSIS OF WHEAT
The different properties of ground and unground samples when analyzed with NIR are demonstrated exemplarily with grains of wheat. The samples were analyzed 10 times, the spectrometer was refilled for every measurement. The wheat grains were previously ground in RETSCHs cyclone mill TWISTER. The table shows a considerable difference between ground and unground sample, particularly with regards to ash and ber content. This is due to the fact that only the surface of the unground wheat grains is analyzed resulting in an over representation of the kernel shell. NIR spectroscopy allows to determine a series of relevant parameters in feeds and grains without great effort. The prevalent opinion is that sample preparation is not required for NIR analysis. However, the results presented here clearly indicate that it is benecial to pulverize the samples with a suitable laboratory mill before analyzing it, particularly if the material is inhomogeneous. That is the only way to guarantee meaningful and reliable analysis results.
Parameter
Ash
Moisture
Fiber content
Fat
Protein
unground wheat average standard deviation 0.10 0.10 9.80 0.25 6.90 0.62 1.38 0.16 8.46 0.45
ground wheat average standard deviation 2.80 0.03 9.68 0.09 1.10 0.05 1.17 0.03 9.02 0.07
Fiber content
ber content
unground wheat
ground wheat
sample no.
The analysis of the unground sample clearly shows a systematic as well as a considerable statistic error.
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Focus on ALLERGENS
of many families. The good news is that the packaging now states the possibility of cross-contamination with peanuts. This sole statement may prevent another child or adult from possible peanut exposure.
How Can Food Manufacturers Benefit from Consistent Reporting and Allergen Control?
Food manufacturers want to maintain the quality and integrity of their brand. Typical media advertisements do not persuade this unique customer population to purchase products; instead, they look at the reputation of the safety of a product, confer with other consumers like themselves, consider the allergenic and gluten properties of the brands product line and assess whether Good Manufacturing Practices (GMPs) and an allergen-control plan have been implemented correctly. They want to be assured that the manufacturing facility has employed these practices and that any possibility of crosscontamination at every stage has been disclosed. The result is favorable word of mouth and wordon-the-web advertising with a projected reach of millions of people.
control plan, provide accurate disclosure on food labels and regularly train their employees to uphold GMPs. Companies using this process can benefit from the resulting increased demand, consumer loyalty and long-term growth. n
Julie Trone is founder and CEO of Allergy Free Table LLC, a company that provides both free and affordable resources for families, educators and caregivers who manage food allergies. Over the last decade, her philanthropic work has spanned food allergy safety, advocacy, education, family support and promoting wellness. She is currently working on two pocket guides: Food Allergies & Grandchildren: Pocket Guide for Grandparents and Food Allergies & Camps: Pocket Guide for Camp Leaders, Scout Leaders, and Staff.
What Do Consumers Want?

Consumers want to be safe from exposure to any food that may cause illness or death. Communication is a less costly method of informing the consumer of inherent risk. The consumer also wants knowledge about how a problem was solved and whether management is following an allergencontrol plan. With these communication tools in place, the consumer can make a conscious decision whether a particular food is safe for consumption.
...many large
manufacturers have
been leading the pack in quality control of allergen and gluten contamination.
References
1. www.packagedfacts.com. 2. www.strategyr.com/Food_Allergy_and_ Intolerance_Products_Market_Report.asp. 3. www.cdc.gov/nchs/data/databriefs/db10.pdf. 4. www.aaaai.org/about-the-aaaai/newsroom/ allergy-statistics.aspx. 5. digestive.niddk.nih.gov/ddiseases/pubs/ celiac/#common. 6. www.biomedcentral.com/1741-7015/9/23. 7. Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Food Allergen Labeling and Consumer Protection Act of 2004, Public law 108-282, Report to the Committee on Health, Education, Labor, and Pensions, United States Senate and The Committee on Energy and Commerce, United States House of Representatives, July 2006. 8. Atkins, S. and M. Hagen. 2012. An integrated approach to food quality and safety: A case study in the cookie industry. Food Safety Magazine 2:4654. 9. www.expertrecall.com/wp-content/uploads/ Quarter-Four-ExpertRECALL-Index.pdf. 10. www.slideshare.net/KimKoeller/what-glutenand-allergy-free-consumers-want-global-marketresearch-executive-summary. For more information on the control of gluten contamination, please visit www.foodsafetymagazine.com/ signature.asp.
What Are the Trends in this Emergent Market?
The demand for variety, quality assurance, accurate labeling and improved taste are ever present in this emergent market. A survey by Allergy Free Passport, a global health-consulting firm, of consumer trends in the gluten- and allergen-free marketplace suggests the need for expanded training, better taste and a wider selection of products.10 Here are two examples of successful product development with allergen and gluten controls in place: 1. ConAgra Mills, a large miller in the U.S., contracts with a dedicated facility to mill gluten-free flour. 2. Canyon Bakehouse (Loveland, CO) has grown exponentially with sales of gluten- and allergen-free breads and muffins. This company uses a dedicated facility and provides the consumer with necessary information about allergen and gluten exposure on both the label and the website.
August n September 2012
What Are the Next Steps?

Due to the voluntary nature of disclosure, the next steps by the consumer may be the following: 1. Lobbying for additional regulations for strict allergen and gluten reporting 2. Lobbying to ensure appropriate allergen-control plans are in place throughout the supply chain This unique consumer base requires these changes for their end result, that is, good health. Manufacturers have the opportunity to voluntarily monitor and improve their method of detecting and reporting allergens and gluten prior to any newly introduced legislation. The technology is available for these processes to be better than the current standard. It is completely appropriate to require suppliers of raw ingredients to disclose allergen and gluten exposure, implement an allergen-
19
International Food Safety

By Hein Timmerman, M.Sc., M.B.A.
Planet versus Profit

Sustainable solutions for cleaning & disinfection
This is one in a series of People, Planet, Prosperity and the Food Chain (P3FC) articles, essays and comments from assorted authors. All articles in the series address the challenges of producing nutritious and affordable food in a profitable way without damaging our planet or exploiting our fellow humans. All participants are volunteers and food professionals, coming from diverse employment sectors and from around the globe. If you are interested in contributing an article to the P3FC series, please send an e-mail to the lead editor: katherine.flynn@ safeconsortium.org.
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is not endemic across all or even most organizations or countries. However, as regional legislation, such as REACH in Europe (the European Community Regulation on chemicals and their safe use: Registration, Evaluation, Authorization and Restriction of Chemical substances) or a globally harmonized system (GHS), becomes more prevalent, as organizations see the economic, social and environmental benefits of green cleaning and as competition pressures impact cleaning service providers, green cleaning will become more widespread and, ultimately, the norm.
roduction hygiene and cleaning are unavoidably linked. However, the environmental impact of traditional cleaning is in contradiction to a globally sustainable strategy. Sustainability is also about social responsibility and the global community. Creating a cleaner, healthier future for all begins at the doorstep of every producer. In order to make a public commitment to challenging and measurable reductions in environmental impact, innovative projects are required that will also drive continuous improvement in operational profiles and profits, and benefit people and the environment.
Defining Green Cleaning

Green cleaning is an integral element of sustainability and, therefore, before defining green cleaning, we first need to define sustainability. There are many definitions and interpretations of what sustainability entails. Many use sustainability, green or environmental interchangeably, but the most widely cited and accepted definition comes from the so-called Brundtland Report. Sustainable development is development that meets the needs of the present without compromising the ability of future generations to meet their own needs. The Brundtland Commission, formally the World Commission on Environment and Development, and known by the name of its chair, Gro Harlem Brundtland, has published in the Report of the World Commission on Environment and Development.1 The Brundtland definition has been further refined to become the triple bottom line, sometimes referred to as 3BL or TBL, and is currently the most common concept used by large national and international organizations. The triple bottom line of social, environmental and economic factors, also known as people, planet, profit, uses an expanded scale of values and
Background
A great deal has been written about sustainability, much of it confusing and even contradictory. Some even suggest that sustainability is the latest business fad and will soon be replaced by the next vogue. It is true that sustainability has developed from its original green concept and continues to go through further iterations and definitions. Moreover, as more organizations adopt sustainability practices and offer more sustainable products and services, any competitive advantage and differentiation will diminish, requiring businesses to differentiate themselves in other ways. Exactly the same is true for green cleaning. At its outset, green cleaning essentially involved the use of environmentally preferable chemicals. Although an acceptable first rung on the ladder approach, green cleaning has gone through several developments, including the incorporation of environmentally preferable tools, equipment and paper goods. At one level, green cleaning is a fad inasmuch as it

criteria for measuring an organizations success. Figure 1 illustrates how sustainability is at the crossroads of these three ideas. Therefore, it is reasonable to expect that a comprehensive green cleaning program should encompass not only environmental considerations, but also social and economic considerations. are two important points to note on biodegradability: 1. Biodegradability is only defined for organic substances, that is, those substances that contain carbon. Inorganic substances that do not contain carbon, for example, sodium hydroxide, are not by definition biodegradable. 2. Technically, biodegradability is defined for substances (essentially single raw materials) and not for mixtures. Given that the vast majority of cleaning products are a mixture of a number of organic and inorganic substances, including water, it would be inaccurate to claim that a cleaning product is 100%
Defining Green Chemicals

There are many valid, and arguably as many invalid, interpretations or definitions of a green cleaning element. Many definitions/interpretations go beyond what the product should and should not contain. However, there is a common notion that a green or enviSAFELINE
Checkweighing Metal Detection & X-ray Inspection
HI-SPEED CI-VISION
Vision Inspection
the environmental impact of traditional cleaning is in contradiction to a globally sustainable strategy.

ronmentally friendly chemical is denoted by a valid eco-accreditation such as the EU Eco-Label (EU Flower) and the Nordic Eco-Label (Nordic Swan) in Europe, and Green Seal and Environmental Choice in North America. That is not to say that one accreditation is better or worse than any other, merely that there are differences and, as such, eco-labels are not an ultimate definition of green. Moreover, few, if any, eco-labels have specific criteria for products that have a disinfection or sanitization function. Apart from eco-labels, other definitions of green require that the product be biodegradable and/or natural. However, these conditions also raise issues. Biodegradable: Many cleaning products claim to be 100% biodegradable. In Europe, there
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11/25/2011 10:50:29 AM

Clean Air, Water & Land Emissions Reductions Zero Waste, Releases & Spills Biodiversity Health & Safety Environmental Regulations Global Climate Change Access to Potable Water Crisis Management Environmental Justice
Environmental Stewardship
SocioEnvironmental Sustainability EcoEfficiency
Resource Efficiency Product Stewardship Life-Cycle Management Products to Services
Diversity Human Rights Indigenous Communities Labor Relations
Social Progress
SocioEconomic
Economic Growth
Job Creation Skills Enhancement Local Economic Impacts Social Investments Business Ethics Security
Innovation Capital Efficiency Risk Management Margin Improvement Growth Enhancement Total Shareholder Return
Figure 1: People, Planet, Profit
biodegradable. Regarding surfactants, it has been the law in the European Community since 1978 for surfactants to be biodegradable. Thus, unless there was something unique or specific about the biodegradability of the surfactants used, which should be identified by the manufacturer, a user cannot claim and should not infer that one product is superior to another solely by a biodegradability claim. Natural: An ever-growing number of products claim to be natural. However, there is the very common misconception that being natural is somehow better for human and/or environmental health. In nature, there are many things that are harmfulasbestos, cyanide, mercury, HIVto name but a few. Of course, the cleaning industry needs to reduce its reliance on petroleum, as it is a finite resource, but natural cleaning products are not necessarily the answer. The discussion document Meeting Natural Expectations, published by the UK Cleaning Products Industry Association, points out that the separation of things natural from things chemical is irrelevant and essentially meaning22
less. Indeed, arguably, the greatest uses of natural materials in the majority of cleaning products are fragrances. Due to human health concerns over some fragrance ingredients, eco-labels tend to control/limit their use, and some are even banned under the Environmental Choice Program Standard for Household, Industrial and Institutional Hardsurface Cleaners, CCD-146 March 2007.2 However, whether it is an eco-label, biodegradable, natural or any other environmental claim, there is considerable risk of greenwashing. In December 2007, the environmental marketing firmTerraChoicereleased a study called The Six Sins of Greenwashing,3 which found more than 99 percent of 1,018 common consumer products in North America randomly selected for the survey were guilty of greenwashing. According to the study, the six sins of greenwashing are: Sin of the Hidden Trade-Off: For example, energy-efficient electronics that contain hazardous materials Sin of No Proof: For example, shampoos claiming to be certified organic but with no verifiable certification
Sin of Vagueness: For example, products claiming to be 100 percent natural, when many naturally occurring substances are hazardous, like arsenic and formaldehyde Sin of Irrelevance: For example, products claiming to be CFC-free, even though CFCs were banned 20 years ago Sin of Fibbing: For example, products falsely claiming to be certified by an internationally recognized environmental standard like EU Flower Sin of Lesser of Two Evils: For example, organic cigarettes or environmentally friendly pesticides In April 2009,TerraChoice published a second report on the subject. This report noted the emergence of a seventh Sinthe Sin of Worshiping False Labels committed when a product, through either words or images, gives the impression of third-party endorsement where no such endorsement actually existsfake labels, in other words. The ecological mantra is Reduce, Reuse, Recycle, in that order. It is much better to reduce the amount of, say, plastic waste than to be primarily concerned about recycling that waste. At this point, it is worth clarifying what recycling means. Recycling is about taking a waste product, such as packaging, and through a relatively complex process, turning it into something else that is useful. Therefore, taking waste plastic packaging and turning it into a garden bench or a signpost is recycling. Refilling empty containers following minimal processing, such as rinsing, is reusing. With that in mind, cleaning products should be: 1. As concentrated as possible/practicable, as this reduces the amount of manufacturing energy and transportation waste in moving to and from the manufacturer/customer and waste packaging. 2. In the largest container as possible/practicable, as, obviously, very large containers create issues such as

manual handling, storage, budgetary constraints, shelf life, etc., but they reduce production of and waste resulting from packaging. 3. Products with integral dilution control measures, as this reduces not only the amount of waste chemical due to overdosing but also the resultant waste packaging, transportation, etc. and the impact of using too many chemicals. It may always be possible to find a greener or a more socially acceptable and/or a lower-priced product, but at what final cost? Is an eco-labeled, natural, nonclassified low-price product the most sustainable? In reality, therefore, the most sustainable/greenest product is the one that satisfies most of the sustainability criteria, most of the time. mental stewardship, social progress and economic growth. While the concept may go through further iterations and refinement, economic and legislative factors alone mean that green cleaning will become more prevalent on more sites and in more countries. There are issues (and opportunities) in defining what is green on a personal, pan-regional or global level, and in having a consistent or at least mutually acceptable eco-label system for both products and services. Commitments to reduce greenhouse gas emissions, leadership in water management and partnerships to protect the earth are essential elements for environmental stewardship and industry leadership. Innovations should focus on validating these sustainability claims. n
References
1. United Nations. 1987.Report of the world commission on environment and development: Our common future. General Assembly Resolution 42/187. 2. Canadian Environmental Protection Agency. 2007. Environmental choice program standard for household, industrial and institutional hardsurface cleaners. CCD-146. 3. Schaefer, P. 2007. The six sins of greenwashing Misleading claims found in many products. ENN, US.
Conclusions
Green cleaning should be and is based on sound sustainability principles, addressing the needs of environ-
Hein Timmerman, M.Sc., M.B.A., has masters degrees in food technology from the Technical University in Ghent, Belgium, and business administration from the Economical High School in Brussels. He has 27 years of experience in the food processing industry, from engineering and project management to sales and business development. He is a member of the European Hygienic Engineering & Design Group and can be contacted at hein.timmerman@gmail.com.
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23
ReguLATORY REPORT
By Douglas Karas
CORE: FDA Foodborne Illness Response Network

FDAs new concept completes successful first year
very second counts. Never is that more true than when dealing with illness outbreaks. A faster disease outbreak response can mean fewer illnesses. With that in mind, the U.S. Food and Drug Administration (FDA) set about creating an organization that would accelerate and streamline the agencys foodborne illness response, and a year ago this month, when the pieces were put in place to create the Coordinated Outbreak Response and Evaluation (CORE) Network, it was ready to test this new concept (Figure 1).
SIGNALS
Receive data from internal and external sources CORE TRANSFER FROM SIGNALS TO RESPONSE Sources are found
RESPONSE
Plan, strategy and objectives to include assignments and activities Assignments and activities are completed CORE analyzes, manages and shares information received
In the past, upon learning of an outbreak, FDA would form a team, drawing staff from across the agency to respond. With CORE, FDA made a commitment of full-time staff dedicated not just to coordinating the response to an outbreak that was underway, but also to more rapidly identifying new outbreaks, and developing plans and policies that might prevent outbreaks in the future. CORE divides outbreak response activities into three phases: Phase One: Find the outbreak Phase Two: Stop the outbreak Phase Three: Prevent the next outbreak By assigning teams of experts to each of these phases, FDA expected to accomplish three goals. FDA expected to respond with increased speed. It expected to respond with increased consistency, and it expected to incorporate lessons learned from each response into future responses and into policies and other actions aimed at preventing future foodborne illnesses. Our teams include epidemiologists, microbiologists, veterinarians, environmental health specialists, consumer safety officers, and policy analysts, explains Dr. Kathleen Gensheimer, chief medical officer and director of CORE. By dedicating experienced staff from a range of pertinent fields to each phase, we create a consistent, continuous operation. I think this has been key to the efficiency and success of this three-pronged effort to fight foodborne illness.
Experiencea CORE Competency

In staffing CORE, FDA recruited from its pool of experts who had previously responded to outbreaks, therefore ensuring that hard-won experience was the very foundation of the new system. From the beginning, nobody in FDA doubted the concept, but certainly nobody could have predicted it would be tested and proven to work the very next
ADDITIONAL ACTIVITIES ARE NEEDED
CORE TRANSFER FROM RESPONSE TO POST-RESPONSE
POST-RESPONSE
Post-response activities are conducted CLOSE INCIDENT
Figure 1: CORE Work Flow
24
Food Safety Accuracy Speed

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www.biocontrolsys.com | info@biocontrolsys.com
ReguLATORY REPORT
month. Yet on the very day in 2011 that FDA officially announced in a press release that CORE was operational, the agency was issuing another news release warning consumers of what would become the deadliest outbreak of foodborne illness in decades. During that outbreak, linked to listeriosis in fresh, whole cantaloupe from Jensen Farms in Colorado, CORE would test its processes under fire and validate the underlying concept of its creation. But more importantly, through those processes, CORE would save lives. It all starts with signals, says Jeffrey Brown, head of COREs Signals and Surveillance Team. Browns team searches through information on FDAregulated products that is reported into various databases by local and state health agencies, through news stories, and through information shared by FDA field offices. The team members are looking for signals or red flags that could be an early warning of an emerging outbreak. They are in frequent contact with the U.S. Centers for Disease Control and Prevention (CDC), sharing information about food products, disease surveillance trends, and cases of illness occurring in various parts of the country. In addition, the Signals Team searches FDA data for historical information on firms, such as past inspections or sampling results, all in an effort to connect the dots. The team compiles this information into a concise package that will allow the assigned CORE Response Team to hit the ground running. research showing that Jensen Farms had not yet completed harvesting cantaloupe in the region of the country where many illnesses were being reported. From there, the CORE Response Team took over in pursuit of their singleminded goalstop the outbreak. The information passed on from the Signals Team to the Response Team allowed quick mobilization of FDA investigators, who, along with key partners like CDC and Colorado state officials, inspected Jensen Farms and were able to collect samples confirming the farm as the source of the listeriosis outbreak. By September 14, Jensen Farms had initiated a recall of their entire 2011 production line that spanned at least 24 states. The response doesnt end with a press release announcing the recall, though, says Roberta Hammond, COREs response manager. Once the recall starts, we continue coordinating efforts with those of other FDA offices to monitor the outbreak, inform the public, and ensure the effectiveness of the companys recall. In monitoring the effectiveness of the recall, FDA audited nearly 100 percent of the first-tier customers receiving Jensen Farms cantaloupe and many additional secondary receivers of the product. A month after it began, FDA deemed the recall complete. While the Response Team was still actively involved with the outbreak, the Post-Response Team coordinated a vitally important task: an environmental assessment of Jensen Farms to determine what factors might have contributed to the outbreak. The purpose of this type of assessment is to determine how the environment might have contributed to the introduction and transmission of pathogens that have caused illness. This was the first time we had seen listeriosis in whole cantaloupe, says Don Kautter, COREs prevention manager, so it was very important that we be able to assess the processes and conditions on the farm and determine what lessons we could take away from this tragedy. With the cooperation of Jensen Farms, FDA, state, and local officials conducted the environmental assessment at Jensen Farms in late September. The assessment team had expertise in produce safety, agriculture, veterinary medicine, epidemiology, environmental health, and sanitation. This team identified the following factors as those that most likely contributed to the introduction, spread, and growth of Listeria monocytogenes in the cantaloupes: There could have been low-level sporadic L. monocytogenes in the field where the cantaloupes were grown, which could have been introduced into the packing facility. A truck used to haul culled cantaloupe to a cattle operation was parked adjacent to the packing facility and could have introduced contamination into the facility. The packing facilitys design allowed water to pool on the floor near equipment and employee walkways. The packing facility floor was constructed in a manner that made it difficult to clean. The packing equipment was not easily cleaned and sanitized; washing and drying equipment used for cantaloupe packing was designed for and previously used for postharvest handling of another raw agricultural commodity. There was no precooling step to remove field heat from the cantaloupes before cold storage.As the cantaloupes cooled, there may have been condensation that promoted the growth of L. monocytogenes. The findings of the environmental assessment have subsequently been used for educational outreach and guidance to the cantaloupe industry. A major goal of the Post-Response Team is to provide information to update and improve agency policy or
FDA regularly
partners on outbreak
response with federal agencies like the
U.S. Department of
Agriculture and CDC...
CORE at Work: Trial by Fire

During last years listeriosis outbreak, which made 146 people ill and killed 30, the Signals Team was able to provide information garnered from Internet
26
ReguLATORY REPORT
industry guidance that can help prevent future outbreaks, says Brett Podoski, head of COREs Post-Response Team. In revisiting COREs first outbreak response, it is important to understand the pieces that make up the CORE Network. Medicine. However, the CORE Network is far more than that. When thinking about CORE, it is crucial to remember that CORE extends beyond FDA, says Dr. Gensheimer. The CORE response teams are coordinating FDA resources with the resources and efforts of agencies at every level of government. FDA regularly partners on outbreak response with federal agencies like the U.S. Department of Agriculture and CDC, as well as with state departments of health and agriculture and with local health and safety agencies. Since that first test of its capability, CORE has responded to more than 40 outbreaks of varying degrees over the past year. Outbreaks can vary in size and in the severity of the illness, and a major challenge with some outbreaks is the scarcity of information, says Hammond. Sometimes there is not enough information to determine the cause, but we take each incident as far as we can. Our Signals and Response Teams are typically working on several outbreaks at any moment, says Dr. Gensheimer. Once one outbreak is winding down, theres usually no time before the next one. The Post-Response Team makes sure that we take what we have learned and apply it to future incidents. To me, thats a recipe for providing the nation with a nimble, flexible capacity to more rapidly respond to, investigate, and prevent foodborne outbreaks. CORE will only get better in each coming year. n
Douglas Karas is a communications specialist with the CORE Network. He has 17 years of experience in public affairs, having worked for the U.S. Air Force and, most recently, as a press officer for FDA.
...CORE has
An Extensive Response Network
The CORE Network includes all the key strategic FDA resources in place in the fieldthe district offices and regional specialists; the regional emergency response coordinators that work with state partners; the Office of Crisis Management at FDA; FDAs Offices of Public Affairs and External Relations; and the subject-matter experts at the Center for Food Safety and Applied Nutrition and the Center for Veterinary
responded to more
than 40 outbreaks of
varying degrees over the past year.
INT
RODUCIN
New EpowerTM Certified Reference Material (CRM) is a quantitative microorganism preparation. For Testing Laboratories, Section 5.6.3.2 of ISO 17025:2005 states: Referencematerialsshall,wherepossible,betraceabletoSIunits ofmeasurements,ortoCERTIFIED REFERENCE MATERIALS. Includes Certificate of Analysis!
www.microbiologics.com
29128_5_EPowerCRM_HalfPage.indd 1
Reference Material Producer CERT # 2655.02
7/2/12 4:47 PM
27
SANITATION
By Jim Fredericks, Ph.D., and Missy Henriksen
Pests: Everyday Threats to the Human Food Supply

The consequences of lax pest management can be devastating
ccording to 2010 estimates from the U.S. Centers for Disease Control and Prevention, about 48 million people get sick, 128,000 are hospitalized and more than 3,000 die each year from food poisoning in the United
These actions represented a clear and significant violation of food processing standards. Plant inspections revealed mold growing on ceilings, rainwater leaking into the production areas, large gaps providing easy access for rodents and the presence of dead cockroaches throughout the plant. What made the case even worse is that federal investigators discovered e-mails between company executives that revealed their knowledge of these conditions and the positive tests for Salmonella within products over a 2-year period. Both cockroaches and rodents are known vectors of Salmonella, which can be found in rodent droppings and on the legs and bodies of cockroaches, easily contaminating areas around them. PCAs actions led to a major national Salmonella outbreak that ultimately caused more than 700 cases of Salmonella poisoning in 46 states, resulting in nine deaths. As this nightmare unfolded, PCA filed for bankruptcy amid a series of lawsuits.
States. Although food can become contaminated at any point during production, unsanitary conditions coupled with disease-carrying pests in food facilities can cause widespread outbreaks. Pest management can be challenging even on a small scale and may seem overwhelming in larger instances such as in food processing facilities, warehouses and the like. Regardless of operation size, the consequences of lax pest management can be devastating.
Pest Threats in Food Processing and Storage Environments

Managers of food and beverage processing facilities and warehouses are required to adhere to a number of health codes, but pest management is among the most important and most challenging. These types of facilities provide the perfect conditions for a variety of pests, offering rodents, flies, cockroaches and stored product pests such as beetles and Indian meal moths plenty of food, water and hiding spots for nesting. Since these pests tend to be the primary culprits behind the adulteration of the food supply, the managers of food processing and storage facilities must be fully aware of the hazards posed by each pest. Rodents Rodents, including mice, Norway and roof rats, present the biggest problem
Negligence and Consequences

Many people inside the food manufacturing and safety industry, as well as the average consumer, are all too familiar with the recent spate of food contamination events, illnesses, deaths and recalls. One of the largest and most expensive food recalls in the history of the United States occurred in January 2009, when officials from the U.S. Food and Drug Administration learned that Peanut Corporation of America (PCA), headquartered in Lynchburg, VA, had shipped peanutbased products contaminated with Salmonella bacteria 12 times in 2007 and 2008 from its Blakely, GA, facility.
28
SANITATION
in food processing and storage facilities. The frequency with which mice and rats urinate and defecate allows for accumulation of excrement, which easily spreads bacteria and contaminates food. These rodent droppings are known to transmit pathogens that cause diseases including hantavirus and salmonellosis. In addition to numerous health risks, rodents can chew through wallboard, cardboard, wood and even electrical wiring, causing expensive damage and posing a fire hazard. Each year, rats contaminate and destroy enough food worldwide to feed 200 million people. can also pick up germs and debris on their legs while crawling through sewage and debris, which can be transferred to food, food surfaces and processing equipment. Stored Product Pests This category of pests includes Indian meal moths, flour beetles and weevils, which can infest plant equipment and contaminate food by leaving body parts and cast skins inside. Another concern is that these pests may accidentally be ground up into food products or infest flour, grains and cereals that are then shipped to grocery stores, restaurants and eventually homes. (continued on page 81)
...unsanitary conditions coupled with disease-carrying pests in food facilities can cause widespread outbreaks.
Flies The common house fly has been found to carry more than 100 kinds of disease-causing germs, including Salmonella and Listeria. The house fly and its cousin, aptly named the filth fly, breed in moist or decaying garbage or excrement. By moving from garbage and excrement to fresh food, processing equipment and other surfaces, flies have ample opportunities to transmit diseasecausing bacteria and contaminate everything they contact. Cockroaches Cockroaches are easily the most reviled pest and with good reason. They are known to spread at least 33 kinds of bacteria, 6 kinds of parasitic worms and at least 7 other kinds of human pathogens, including Salmonella, Vibrio cholerae and Staphylococcus aureus. They
August n September 2012 29
PROCESSCONTROL
By Bradd Eldridge
Supplier Management: Six Steps to Selecting the Right Supplier

Choosing the ideal supplier is often not easy and requires discipline and hard work
it was first manufactured, but it may not meet shelf-life expectations. In addition, if you needed to go back to the supplier for replacements, they may not have the specific materials, or in some cases, they may no longer be in business. At this point, you are probably thinking, If I had used higher-quality materials from a reputable supplier, my finished product would have met my expectations. Selecting the suppliers who can meet your consumers demand for higherquality ingredients may bring some initial costs, but it will pay off over time through consistent, high-grade materials. However, the process to find the ideal supplier is often not easy and requires discipline and hard work.
1. Identifying a Supplier
f you asked a food manufacturer 20 years ago how they selected an ingredient supplier, they would have likely said it was based on price, flavor or the supplier location and preference. However, as government and industry put a stronger emphasis on food safety and quality, evaluating and selecting the right supplier today has become much more critical and complex. Selecting the right supplier may seem like an onerous process for your supply chain. While having a more simplistic supplier selection process may be helpful for some smaller supply chains, a more involved process of selecting the right suppliers can help many food and nutrition companies meet or exceed regulatory standards, drive customer demand and build a strong brand reputation of quality products (see Supplier Selection Process, p. 31). Quality and safety of our ingredients, products and packaging are paramount to our success at Abbott Nutrition, so choosing a good supplier is a critical business decision. Consequently, our supply chain team has identified six steps for choosing the right supplier, as well as several best practices in the industry. Reflect back to your last home project. Your focus was probably to keep costs low. You may have used a lower quality, cheaper material to save money, and upon completion, were satisfied with the result. Unfortunately, over time, the project did not look as nice as it did at first. Similarly, if you used the same criteria when selecting ingredients for your manufactured food products, its possible that the produced food would look good when
Before selecting your supplier, it is important to gather the opinions of stakeholders and define the criteria for the selection process. This list of stakeholders may include members from research and development, purchasing, marketing, quality assurance and any other area of your organization that touches the supplier selection process. During this time, it is important to identify a few suppliers to assess their capabilities and compare pricing. The supplier selection team should work with the potential suppliers to establish specifications. For example, they should explain how the suppliers materials would be used in your products and within the manufacturing process. Keep in mind that the ultimate goal is a win-win situation for the supplier and manufacturer; therefore, open and transparent communication is extremely important. A key criterion in selecting the right supplier is value. Cost should not be the lone driver; you should instead look at the total cost of ownership, which looks at the suppliers: Customer service Delivery commitments
30
PROCESSCONTROL
Reliability and responsiveness Resource savings (hard and soft)
3. Gaining Supplier Feedback

Another tool you can utilize with suppliers is a self-assessment questionnaire. The supplier self-assessment can be used to identify performance gaps, as well as discover how the supplier understands their own operation. In addition to audits and assessments, it also is beneficial to monitor informative metrics that direct value to the business. You should discuss and select the appropriate metrics with suppliers to receive their input and understanding of purposeful measurements. Examples of these metrics include rejected lots, perfect shipments and documentation errors. The metrics selected should measure the total cost of ownership, as well as improve performance toward the maximum finished product performance.
5. Developing Partnerships
Ultimately, the manufacturer/supplier relationship is at its best when a strategic partnership is formed, allowing full knowledge of the source of materials and ensuring high quality. With a stronger business partnership, a supplier is more likely to: Anticipate what is needed from the manufacturer and begin to take the leadership role in communication. Notify the manufacturer if problems occur that limit production availability, or a quality issue is identified. Communicate production delays when downtime or maintenance is required. This type of partnership allows for an increased understanding and mutual benefits for both parties. It cultivates stronger commitments and encourages a greater interest in success for the material and finished goods. This type of relationship is your ultimate goal. However, there are risks associated with forging this kind of partnership. Trust in both parties becomes paramount, and both entities must ensure no potential or real conflicts of interest occur. When both parties become more reliant on each other, if there is a breakdown on either side or the relationship dissolves, there is much more to lose.
2. Measuring Supply Performance

Another important step of the supplier management process is developing an audit and assessment program. Best-in-class supplier programs conduct audits throughout multiple stages of the manufacturer/supplier relationship. You should always conduct an audit before the contract is signed to confirm that the supplier does not have any significant compliance or quality system failures that could affect your ability to produce top-quality products. Another reason to conduct the audit beforehand is to understand the suppliers strengths and weaknesses before the relationship becomes official. Even after the contract is signed, you should continue auditing, basing the frequency of the audits on the criticality of the supplier. To determine the frequency, all suppliers should be categorized into a level of risk or importance. This prioritization will help you be smarter and more effective with your resources and place a higher focus on your important, high-risk suppliers, while continuing to monitor second-tier suppliers. Beyond an established audit program, you should continuously monitor and assess each suppliers performance. You can track positive or sustained strong performances, as well as negative trends.
4. Achieving Certification
As your supplier relationship grows stronger, and both parties feel they are receiving positive performances, the supplier may be able to achieve a certified status. This occurs when you establish a set of selected criteria to be met by your suppliers. Certification must be obtained with sustained successful performance and can be lost with poor performance or a negative compliance outcome from an audit. As the relationship continues to grow, the supplier also will become more integrated into your manufacturing process.
6. Ensuring Quality for Consumers

Depending on the number of materials and ingredients needed, developing a supplier quality management program can be a complex and upfront investment. However, once you choose to build strong relationships with reliable suppliers, you will have peace of mind, knowing youre delivering high quality to your consumer. The benefits are realized when your supplier quality team is focused on issues other than material quality, and your satisfied end-users have confidence in the products you provide.
Bradd Eldridge is the director of quality assurance at Abbott Nutrition.
Selecting the right supplier can help you meet the consumer demand for higher-quality ingredientswhile also meeting high regulatory standards. When selecting the right supplier, manufacturers should remember to: Include all key internal stakeholders in the process to agree on important criteria that the supplier should meet. Require strong communication between the manufacturer and the supplier. Good communication might not necessarily confirm a successful relationship, but poor communication can almost guarantee a failed relationship. Perform audits for the selected supplier, and work with them to address any deficiencies. If the deficiencies are too great, move on to another supplier. Implement adequate monitoring to drive improvement in supplier performance. Assess performance through useful metrics and provide the necessary feedback to the supplier. Establish an effective certification program and utilize it when the supplier has met its standards. Motivate your suppliers to develop strategic partnerships to ensure the greatest opportunity for success for both parties. Invest sufficient time, effort and energy early in the relationship to set up for success.
Supplier Selection Process
31
PACKAGING
By Julie Ackerman
Trends in Food Packaging: Borrowed Expertise

Food packagers gain insight from the pharmaceutical industry
s the U.S. Food and Drug Administrations (FDA) Food Safety Modernization Act (FSMA) begins to be implemented, food packagers can no longer rely on business as usual. The law, which was signed by President Barack Obama on January 4, 2011, shifts the food industry to a risk identification and mitigation strategy to protect food safety, after decades of taking a reactive stance. Provisions of the food safety law require enhanced product traceability, give regulators greater access to production records and expand record-keeping requirements. In fact, under FSMA, food packagers must draft riskassessment plans identifying potential hazards and develop and document a corrective plan of action.13 Although regulations are in various stages, theres no doubt FSMA will require changes on packaging lines. And experts speaking to Packaging Machinery Manufacturers Institute (PMMI) members at PMMIs Executive Leadership Conference in April made it clear that food packaging equipment suppliers will need to make safety, quick sanitation and trace-and-recall capability top design priorities.4 Under current Good Manufacturing Practices (cGMPs) governing the industry, pharmaceutical packagers must meet similar requirements. Ive observed a continuing trend of food manufacturers coming closer and closer to the same kinds of practicesdetailed documentation and record keeping, step-by-step manufacturing and monitoring, says Eric Greenberg, a food and drug law attorney in private prac-
tice in Chicago predicting, FSMA will accelerate this trend. Along with the shift to more proactive food safety strategies, FSMA will require food companies to adopt Hazard Analysis and Critical Control Points (HACCP) methods. These methods center on analyzing every step of a process to identify where hazards might occur. The food manufacturer is then expected to implement controls at those points and see to it the controls are practiced 100 percent of the time. In turn, Greenberg predicts, the adoption of HACCP practices by food packagers will inspire packaging [material and machinery] manufacturers to undertake such controls voluntarily. As a result, we may see a transition to more sophisticated food processing and packaging equipment. Since food safety risks often involve the introduction of contaminants or the failure to remove or render them harmless, many CCPs involve packaging materials or packaging equipment. For food packagers complying with FSMA, that will mean considering more stringent cleaning regimens, integrating additional inline quality monitoring equipment (e.g., machine vision and/or X-ray inspectors and metal detectors) and installing risk-mitigation equipment (e.g., inline cap sanitizing systems).
Equipment Design
To comply with FSMA, packaging equipment, including inspection systems, will need to be installed, validated and continuously monitored to confirm performance consistently meets expectations. Validation and performance must be documented.5 Recently, PMMI asked food packagers about the changes needed to meet FSMA requirements, and many of the responses focused on designs not unlike those of packaging machinery on pharmaceutical lines:6
32
Theres an App for That

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PACKAGING
Track and Trace
Federal traceability requirements to help prevent counterfeiting and diversion of pharmaceutical products appear to be stalled for now. However, pedigree laws looming in California (and already in effect in countries like Turkey) have spawned hardware and software capable of providing the coding and database information needed to authenticate product from point of packaging to point of purchase. If a product quality problem is detected, pedigree information can also be used to quickly identify, locate and recall affected products. These hardware and software technologies could help food packagers meet FSMAs traceability requirements. The evolving pharmaceutical traceability effort now often consists of an integrated system from a single vendor. Equipment typically involves coders/ printers capable of applying alphanumeric, one- and/or two-dimensional bar codes to containers, labels or packaging materials, plus inspection systems to verify code quality and capture code information along the packaging line. Hardware also includes code-capturing devices that supply chain partners, law enforcement personnel, regulators and consumers use to authenticate product. Although many proprietary code-scanning devices exist, increasingly, this function is often performed with a smartphone.
(continued on page 51)
Figure 1: Hygienic design of quick-change feeder for syringe filling line features stainless steel construction, smooth welds and an absence of visible fasteners. Image from Service Engineering Inc.
Eliminate equipment areas and surfaces that can trap and grow bacteria More waterless and dry-process technology Increased modularity and cleanability Larger clearances under and above equipment for easier cleaning and maintenance More stainless steel construction (Figure 1) Design machinery to keep infrastructure changes at a minimum for installation Physical barriers between high- and low-risk areas to prevent spread of contamination Unquestionably, concepts are being borrowed from the pharmaceutical realm, says Greenberg. This has been particularly true of regulators, but theres also been a trend of food companies voluntarily borrowing concepts. Other hygienic design features include smooth welds, the elimination of exposed fasteners and crevices that collect dirt/debris and the use of angled surfaces to prevent pooling of water, cleaning agents or other liquids. Hygienic design also tends to be modular, either with downtime-reducing quick disconnect/connect hardware or clean/ sterilize-in-place functionality that eliminates, or at least minimizes, the need for disassembly/reassembly (Figure 2).7, 8
Record Keeping
Record keeping ranks as a primary cGMP requirement for the pharmaceutical industry, and automated record keeping is replacing old paper-based systems. Regulations outlining the criteria for converting electronic records, electronic signatures and handwritten signatures to electronic records equivalent to paper records and handwritten signatures are defined in 21 CFR Part 11.9 As a result, depending on how final regulations are written, food packagers may be able to comply with FSMA record-keeping requirements by adopting technologies already validated in the pharmaceutical industry, including those offering Part 11 compliance.
Figure 2: Inline equipment is available to sanitize caps and bottles. Image from Fogg Filler.
34 Food Safety Magazine
I N S I D E R
Innovation applied
food quality and safety expertise delivered
Scientists at the Thermo Fisher Scientific Food Safety Response Center
AD63639_E 07/12M
You might be surprised

Editorial by Dom Testa, Vice President of Marketing Chromatography and Mass Spectrometry
An inside view of our portfolio and expertise
Prior to joining Thermo Fisher Scientific, I was familiar with the companys product portfolio in chromatography, mass spectrometry, atomic and molecular spectroscopy. But as a newcomer who just joined the company, I discovered that we provide much more to customers in the food industry. Not only do we have a comprehensive portfolio that is used throughout different segments of the food industry; we also offer a superior level of expertise applying our technologies and products to provide solutions for some of the industrys biggest problems. The detection of pathogens is of great concern to the industry. Being able to detect pathogens in an accurate and timely manner is the goal of every microbiology lab, and we have a fantastic range of products that can help accomplish this goal. As an instrument supplier of both chemistry and biology products, we are seeing the lines between chemistry and biology testing blur. Mass spectrometry is being used to provide insight into the complex characteristics of pathogens to complement classic biological identification. Our capabilities in both disciplines, chemistry and biology, can provide customers new and exciting solutions to address identification problems in their labs. One of the most powerful tools revolutionizing the area of food safety is the Thermo Scientific Q Exactive benchtop mass spectrometer. Because the food supply is truly global, there are always new contaminants that need to be identified or lower levels of known contaminants that need to be quantified. The power of the Q Exactive lies within its ability to provide high-resolution, accurate-mass (HR/AM) data for all of the compounds analyzed. This enables users to perform true, targeted and non-targeted screening of contaminants with the same instrument. In last years Food Safety Insider, we shared how Dr. Jana Hajlov from the Institute of Chemical Technology in Prague used HR/AM for the analysis of 32 mycotoxins in the complex matrix of beer. In this years Insider, we describe how we have taken this technology further through a multi-mycotoxin method that simultaneously targets well-known mycotoxins and screens for over 600 fungal metabolites in a single run. Our capabilities in handheld technologies, Laboratory Information Management Systems (LIMS), and laboratory asset management were also surprises to me. The food industry wants to be able to get fast answers on incoming raw materials and our handheld FT-IR, NIR and Raman instrumentation can provide those answers. Data management and traceability are huge challenges for all laboratories and our LIMS help our customers manage these with ease. With our Fisher Scientific and Unity Lab Services brands, in many parts of the world we can outfit entire labs from bench to test tube, offer just in time delivery options, and provide asset management services to improve lab effectiveness and efficiency. If youre in the food industry and involved with protecting public health or providing safe and nutritious food, you need to call us. Like me, youll be surprised with what we can offer and the answers we can provide.
Food Safety Insider
In the microbiology lab

with Ali Ball, Vice President of R&D and Business DevelopmentMicrobiology
Q:
hat types of products do you W offer for microbiology testing in food and agriculture?
Our product range for quality control and food safety microbiology testing includes the dilution, enrichment, isolation, enumeration, detection, identification and confirmation components, which become the total solutions for pathogen, indicator, probiotic and spoilage organism detection and enumeration. The food industry is under increasing financial and regulatory pressure and we recognize that customers are constantly looking at ways to improve and streamline their business. We aim to bring customers those products and solutions that enable them to do this. For example, with the aim of achieving a faster time to result in the Milk Quality laboratory, we developed a range of assays for accurate, same-day identification of mastitis-causing microorganisms from bovine milk using quantitative, real-time polymerase chain reaction (qPCR). PathoProof PCR assays are revolutionary tests for identifying all of the main mastitis-causing bacteria without culturing. Results are available in around four hours, a dramatic improvement over conventional culturing methods which routinely take several days. In coming months, well build on our molecular technology capabilities to expand this product line.
The value that we deliver to customers is based on the fact that we are able to combine many different scientific disciplines to develop workflow solutions. Most assay developers dont have access to such a broad range of technologies to deliver complete solutions.
Q:
ow do you incorporate scientific H expertise in the products you develop?
Q:
Can you give an example of how you help customers address challenges in their laboratories?
In a microbiology lab, considerable labor and time can be spent preparing culture media. This takes technicians away from their primary task of sample analysis. So, the format of culture media is an important area where we have innovated. We offer a wide range of ready-to-use media in a variety of formats such as plates, bottles and tubes, as well as solutions like Dry-Bags. Dry-Bags enable technicians to prepare large volumes of primary enrichment media very quickly and easily. This type of innovation, focused on workflow in the lab, can provide significant time and money savings for our customers.
Most of our scientific expertise is focused on developing products that are easy to use and dont necessarily require a background in microbiology. For example, in recent years weve been able to take the selectivity of some of our culture media to a new level through the development of unique molecules called Inhibigens. These highly-specialized, synthesized molecules combine a substrate component, such as an amino acid or sugar, with an inhibitor. We add Inhibigens to specially-designed culture media for inhibition of specific, competing organisms that are commonly present in the sample alongside the target. This improves both the performance of the medium and the readability of the test. Our Brilliance Salmonella medium combines both Inhibigen and chromogen technology to create a medium that is highly sensitive, specific and easy to read. Designing and developing the Inhibigen molecules themselves is technically very challenging. However, in terms of how the customer uses the product, theyre just a hidden component of their culture medium which makes their laboratory work easier. For more information about the Thermo Scientific microbiology products, including Oxoid and Remel specialty brands, please visit the Microbiological Organisms product category at www.thermoscientific.com/foodsafety.
Food Safety Insider
Using state-of-the-art nano-LC-MS/MS technology to investigate the toxicity of microorganisms

Haroun N. Shah, Min Fang, Raju Misra, Tom Gaulton, Nadia Ahmod, Renata Culak and Saheer E. Gharbia, Health Protection Agency Martin Hornshaw, Jenny Ho, Ali Ball, Thermo Fisher Scientific
Introduction
Microbial laboratories perform analyses to accurately detect and identify pathogens. In mid-May 2011, a serious outbreak of foodborne illness, which included diarrhoea and haemolytic uremic syndrome (HUS), occurred in Germany and spread to neighboring countries. In the following weeks, over 4,000 cases were reported and approximately 50 people died. The use of detective clinical microbiology soon led to the identification of the culprit as Escherichia coli serotype O104:H4. E. coli are mainly commensal organisms, but several pathotypes of diarrhoeagenic E. coli exist. However, the organisms identity posed a puzzle for researchers; a key characteristic of the outbreak was that the HUS manifestations were similar to those triggered by Shiga toxin-producing E. coli. Diarrhoea leading to HUS is traditionally associated with Shiga toxin production, and the strains are referred to as EHEC (enterohaemorrhagic E. coli). However, serotype O104:H4 does not normally harbour Shiga toxin but has the aggregative (adhesion) factors of enteroaggregative E. coli (EAEC). In addition, the strain lacked the enterocyte effacement pathogenicity island, making it even more difficult to achieve rapid and accurate characterization of the strain. Sequencing the genome gave the researchers some insight into the unique combination of genes which had caused the organism to become so deadly. However, it was by mapping the proteins that were actually expressed by those genes that the mechanisms of disease became fully understood and the origins of the organism became clear.
Food Safety Insider
Using state-of-the-art nano-LC-MS/MS continued

Proteomics for Microbiology Applications
The Department for Bioanalysis and Horizon Technologies of the UKs Health Protection Agency (HPA) has been actively engaged in searching for unique, stable protein signatures in pathogenic microorganisms to enable the rapid detection and identification of future pathogenic strains. This has resulted in the establishment of a pipeline for biomarker discovery, integrating protein sequencing with mass spectrometry and bioinformatics technology.
1
Developing an MS-based Approach

HPA and Thermo Fisher Scientific scientists wanted to investigate how the genome sequencing findings could aid in the development of an MS-based approach to detect the outbreak strain and discover new strains in the future. The genomic data revealed how gene transfers between pathotype and serotype of E. coli can lead to the emergence of a new pathogen. In addition, the data allowed scientists to re-examine previous isolates of serotype O104 and it became apparent that this was not a unique event. There are previous reports of O104 strains taking up Shiga toxin genes, and genetic transfer events will continue to lead to new pathogens. Taking this into consideration, it was concluded that proteomics-based tests should incorporate not only signature markers of the genus and species, but also markers of virulence within a species or pathotype to enable identification of emerging pathogens that cause such devastating outbreaks.
Advanced nano-LC-MS/MS technology is a form of mass spectrometry (MS) which, in concert with sophisticated software and bioinformatics tools, has been primarily developed to enable scientists to identify the expressed protein complement of a cell or tissue sample (proteomics). Applying this technique to microbes enables analysis of their specific protein fingerprint. Current MS-based methods used for microbial tests rely on matrix-assisted laser desorption/ ionization time-of-flight mass spectrometry (MALDI-TOF MS) profiles. However MALDI-TOF MS cannot identify the ions that characterize the mass spectrum of the pathogen and, therefore, the exact protein structure cannot be inferred. The team at the HPA, in collaboration with Thermo Fisher Scientific, is exploring the use of proteomics to develop new approaches to characterize microorganisms. This collaboration was put to the test in a project that aimed to provide insight to the toxicity and pathology of the E. coli O104:H4 strain.
Protein Sequence Profiles

A total of five E. coli strains belonging to serotype O104 were subjected to proteomic analysis using a Thermo Scientific LTQ Orbitrap Velos mass spectrometer. These included three isolates from patients affected by the German outbreak (genome sequence of all three isolates confirmed that they were from the same strain) and two others that had previously been characterized as serotype O104, but with EAEC and EHEC genetic composition, respectively. The peptide MS/MS spectra were matched to both protein and in silico genome-translated databases to yield protein identification. These were then fed into the bioinformatics pipeline to acquire unique signatures at genus and species level.1
Food Safety Insider
Proteomics Analysis Results

An extensive list of protein signatures resulted. This reflects the sensitivity and reliability of the nano-LC-MS/MS method to identify specific protein structures. The aim was then to investigate whether peptides resulting from high abundance proteins have unique markers and signatures for genus and species or virulence detection. A total of approximately 2,500 proteins from the outbreak isolates were identified. These were mapped into genus, species and strain-specific markers (not shared by other bacterial strain sequences in the protein database). A total of 68 peptide signatures were identified which delineate the outbreak E. coli isolates, separating them from other closely-related Enterobacteriaceae. In total, 3,031 peptides were identified as unique to the outbreak strains when compared against control isolates. In addition, the Shiga toxins and Pic serine protease (autotransporter toxin) were detected. Encouragingly, genomic features such as tellurium resistance, genetically detected in the outbreak strain, were identified via proteomics. The list of peptides was subsequently filtered to remove peptides derived from physiological and regulatory proteins, thus reducing the complexity of the list. Search of the residual list for E. coli pathotype virulence determinants and virulence factors resulted in a definitive list of expressed virulence determinants of the outbreak strain. The results also support the view that the background genome (biome) came from an EAEC progenitor that acquired plasmids and prophages, and exchanged chromosomal loci leading to the emergence of an aggressive strain with a distinctive profile. All strains shared 89% of the expressed proteins. A total of 31 proteins were encoded by the two plasmids. Peptide signatures for adhesion and multidrug resistance (including -lactamase, CTX-M extended spectrum -lactamase and Metallo- -lactamase enzymes) were observed.
Conclusion
Nano-LC-MS/MS technology helps scientists to better understand the role of pathogenic microorganisms in causing illness and disease in humans. Using this powerful technique, scientists are able to study microorganisms and determine how the genetic code is being translated into the protein building blocks that determine traits such as toxicity. The method has been implemented in this study to determine what makes the new E. coli O104 strain so devastating and how it may be controlled. Experimental results demonstrate that nano-LC-MS/MS accelerates research to identify the sources of E. coli -related illnesses and diseases. Proteomic analysis based on nano-LC MS/MS of microorganisms could provide definitive characterization at the genus, species and, often, strain level. Furthermore, it will enable the detection of pathogenic determinants and antibiotic resistance mechanisms, potentially enabling earlier detection of new pathogens and the development of treatments that are better adapted to evolving microorganisms.
1. A l-Shahib et al., 2010. Coherent pipeline for biomarker discovery using mass spectrometry and bioinformatics. BMC Bioinformatics, 11:437.
For Research Use Only. Not for use in diagnostic procedures.
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The Food Safety Response Center

Responding to the needs of the food safety community
In 2010, Thermo Fisher Scientific established a new laboratory dedicated to rapid analytical method development during incidents of chemical contamination in food. The Food Safety Response Center, located near Frankfurt, Germany, is a fully- equipped sample preparation and instrumentation laboratory staffed with experts in analytical method development for complex food matrices. The first activation and response came just weeks after opening the Center, when the group rapidly developed methods to address potential seafood contamination from the oil spill in the Gulf of Mexico. Since then, the Center has continued to respond to contamination incidents. However, in the past few years, it has also evolved into a valuable resource for the food safety community. As the food supply becomes more global and new issues arise, there is greater demand for resources across the spectrum of food analysis. Scientists looking to partner on research projects, customers interested in the application of new technologies in their labs, and individuals from emerging markets seeking training are a few examples of groups who have approached the Center for collaboration and assistance. Through their engagement with a variety of professionals in the industry, the Center has developed a global reputation for providing competent, scientific expertise to address analytical challenges in food testing.
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Food Safety Insider
In the chemistry lab

with Klaus Mittendorf, Manager of the Food Safety Response Center
Q: What makes the Food Safety Response Center a unique resource?
First, the Center is unique because of its incredible flexibility; it is not tied to an outside institution nor was it established to focus on a limited area of research. Therefore, we can establish our own agenda and determine how we can be most effective for those requesting our help. In terms of the projects that we undertake, we are open to ideas generated within the food safety community, which includes many of our customers. In addition, because Thermo Fisher Scientific has such a vast product portfolio, we have access to many different technologies. Instead of having to deliver a solution based on an available instrument, we deliver solutions by matching the best technology to the analytical requirements. If an application is best suited for gas chromatography, we have that option. If it could be done more effectively with liquid chromatography, we have that as well. In the complex world of food analysis, having all of these options means that we arent compromising from the start when we begin working on a method.
Q: Are you currently collaborating with outside organizations?

Oh yes, we are in discussions with food safety specialists around the world and collaborating with authorities and food industry partners to work on the development of new analytical methods. For example, there is a broad range of regulated and unregulated mycotoxins in the EU. Due to climate change, experts are forecasting an increased incidence of mycotoxins in areas where these compounds were not seen before. So, there is a strong need for new methods to screen and to quantify many different mycotoxins. Together with European organizations, we are working on new analytical methods for screening and quantification with our Orbitrap technology
Q: W hat are some of the products utilized in the Center?

Nearly all of the products in the Center are from Thermo Fisher Scientific. From pipettes, chemicals, and consumables to balances and scientific instruments, we are using the whole portfolio of Fisher Scientific and Thermo Scientific products. We have a variety of instruments for automated sample preparation, chromatography, mass spectrometry, and elemental analysis.
Q: When visitors come to the Center, what are they most surprised to see or learn?
Visitors are surprised about our strong scientific approach to analytical challenges as well as our deep understanding of method development in the area of food safety. Because we are suppliers, they may think that we are going to spend all of our time walking around the lab and showing them specific features on all of the instruments. But once they are here, they quickly understand that we are focused on issues around food safety and how we can contribute to solutions. And, our scientists are very enthusiastic to interact with the food safety community to learn from others as well as to share their ideas for new analytical approaches.
Public health laboratory representatives from Thailand recently visited the Food Safety Response Center to learn about its unique capabilities.
Food Safety Insider
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State-of-the-art technologies deliver better methods

In food safety, concerns such as mycotoxins and pesticides have histories dating back more than 50 years, while emerging contaminants like Sudan dyes and the issue of adulteration are relatively recent. Even in areas long-established, technology is constantly improving, providing the opportunity to improve the efficiency and reliability of existing analytical approaches or even supplant them. Some recent projects at the Food Safety Response Center show how state-of-the-art technologies are being applied to develop better methods.
Addressing the Challenges of Multi-class Veterinary Drug Residue Analysis

The need to monitor milk, meat-based products and aquaculture products for veterinary drug residues brings analytical challenges. In many countries, certain drugs are banned for use in animal production. The detection of any residue above the minimum required performance limit (MRPL) can result in regulatory action. Levels can be as low as 0.3 g/kg: the MRPL for chloramphenicol. Other substances are permitted for use in animal husbandry, but withdrawal periods are set to help ensure that residues in tissues are below the maximum residue limit (MRL). Veterinary drugs fall into classes such as sulphonamides, quinolones, tetracyclines, and aminoglycosides. Traditionally, extraction and cleanup procedures have tended to be deliberately selective based on the chemistry of the targeted compound class. These procedures, carried out on batches of samples, are time-consuming because they require considerable manual manipulation. In contrast, an innovative technology called turbulent flow chromatography is a more generic cleanup technique. It uses both the sizes of target compounds and their polarities to effect a purification of sample extracts. The Thermo Scientific Transcend TLX system combines on-line sample prep (TurboFlow technology), analytical HPLC and mass spectrometric detection. It fully automates turbulent flow chromatography and provides novel, versatile on-line sample preparation. An advantage of TurboFlow methods is that frequently the same method can be used for the analysis of compounds found in different matrices. The key to the success is the optimization of the TLX system to ensure maximum recovery of the target compounds while minimizing the co-elution of co-extractives.
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Food Safety Insider
The global use of different classes of veterinary drugs drives the need for multi-class methods that address a wide a range of possible individual substances. Ideally, methods should be automated since veterinary drug residue surveillance requires routine analysis of large numbers of samples.
A recent Food Safety Response Center project utilized this system to detect and quantify 36 individual veterinary drug residues from seven different classes of antibiotics (aminoglycosides, sulfonamides, macrolides, quinolones, tetracyclines, lincosamides and trimethoprim) in milk. A simple extraction of milk with acetonitrile was conducted, incorporating the internal standard. After centrifugation, the extract was injected into the TLX-LC-MS/MS system. Macromolecules were removed from the sample extract with high efficiency, while target analytes were retained on the column, based on different chemical interactions. After application of an automated wash step, the trapped compounds were automatically transferred onto the analytical LC column and separated conventionally. Mass spectrometric analysis was carried out using a Thermo Scientific TSQ Quantum Access Max triple stage quadrupole system. Identification of the antibiotics was based on coincidence of retention times with standards (2.5%), and close agreement of ion-ratios using selected reaction monitoring (SRM) of characteristic transition ions. When identification was confirmed, quantification
was undertaken using matrix-matched standards for one of the selected transitions. Sulfaphenazole was used as the internal standard in the multi-class method. This new method demonstrates how turbulent flow chromatography can improve efficiency and reliability by simplifying cleanup, as well as enabling the user to detect multiple analytes in a single run. The technology is especially useful for routine analysis involving large numbers of samples.
Food Safety Insider
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State-of-the-art technologies deliver better methods continued

Improving Multi-mycotoxin Analysis
The history of mycotoxin analysis can be followed from the days of thin-layer chromatographic (TLC) analysis of aflatoxins through novel developments in sample cleanup (immunoaffinity columns) and use of HPLC with fluorescence detection to more recent, multi-toxin analysis with LC-MS/MS. There have been unquestionable advances in the ability to determine some of the more intractable mycotoxins as well as the improved accuracy of mycotoxin analysis. Nevertheless, there is still a desire to fully automate the cleanup and to screen for a large number of toxins in a single chromatographic run. This goal has been partly met using targeted LC-MS/MS analysis. However, establishing the transition ions to be monitored by MS/MS can create difficulties as the required standards are not always easy to obtain. Recent work at the Food Safety Response Center has sought to use a benchtop Orbitrap mass spectrometer with mass resolution of 100,000 as a high-specificity screening tool for the detection and determination of mycotoxins in cereals and feed. A single extraction step for a number of mycotoxins with differing polarities, which are present in cereals and animal feed, was achieved using a mixture of aqueous formic acid (0.1%) and acetonitrile (43:57). After filtration, the extract was directly analyzed using the Transcend TLX system further coupled to an Exactive MS. The use of the Exactive mass spectrometer at ultra-high resolving power allowed the unequivocal identification of these analytes. This approach tackles two of the major challenges in mycotoxin analysis in a single method. First, targeted Fusarium mycotoxins such as deoxynivalenol, zearalenone, T-2 toxin, HT-2 toxin, fumonisin B1
Orbitr ap Technology for Superior Screening

The Orbitrap mass analyzer, developed exclusively by Thermo Fisher Scientific, uses electrostatic fields to trap ions into orbit around a central spindle. As they orbit the spindle, the ions also oscillate back and forth along the length of the spindle at frequencies proportional to their mass-to-charge ratio. The oscillations of the ions induce currents that can be measured and, through the application of Fourier transforms, converted to mass-to-charge measurements. Orbitrap mass analyzers can be used by themselves in mass spectrometers, or combined with quadrupole or ion trap mass analyzers to create hybrid mass spectrometers with MS/MS or MS n capabilities. Orbitrap-based mass spectrometers have several significant advantages over most other mass spectrometers. Orbitrap mass spectrometers provide good dynamic range, very good mass accuracy (typically a few ppm or better) and mass resolution as high as 240,000. High mass accuracy and mass resolution give these instruments excellent specificity, adding a great deal of confidence to compound identifications. For food screening applications, Orbitrapbased mass spectrometers have numerous advantages. Unlike time-of-flight technology, whose mass resolution falls at lower m/z, Orbitrap mass resolution is highest at lower m/z, making Orbitrapbased instruments unrivalled for the analysis of small molecules. Unlike triple quadrupole instruments, which require time-consuming method development to find the best transitions to monitor and optimize conditions for those transitions, Orbitrap mass analyzers use their superior mass accuracy and mass resolution to provide specificity without complicated method development. Also unlike triple quadrupoles, which collect data only for selected ions, Orbitrap mass analyzers operate in full-scan mode, acquiring data from all ions. Both targeted and untargeted compounds can be identified from full-scan Orbitrap data. The data can be reanalyzed after acquisition as new questions arise.
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Food Safety Insider
In many cases, targeted analysis has not revealed any problems with known mycotoxins. High-resolution, accurate-mass (HR/AM) technology now allows for non-targeted screening and analysis of lesser known fungal metabolites.
and fumonisin B2 can be simultaneously detected and quantified in cereals and feeds. Conventional analyses typically use cleanup techniques focused on individual toxins, making it necessary to run a series of separate analyses to cover all toxins. The online turbulent flow cleanup was optimized to give good recoveries for this range of toxins. Method performance parameters were determined and demonstrated the method to be fit-for-purpose for food control. Second, there has been a longstanding suspicion that cereals and animal feed may contain mycotoxins and other metabolites in addition to the well-known and established toxins. Scanning with high-resolution LC-MS means that data is collected for all compounds eluted during the chromatographic run. The targeted Fusarium toxins can be readily identified from their molecular masses and correspondence with the retention times of standards. Other contaminants in the samples can be screened against a database of accurate masses of fungal metabolites. For this project, a database of 660 metabolites, including all of the well-known mycotoxins, was developed. Using a mass resolution of 100,000 means that, within a 5 ppm window, the number of theoretical possibilities of compounds having the same accurate mass as another is very small and, in most cases, there is only one possible fit. For mycotoxin screening, this approach is not unequivocal but it does provide information about the potential presence of otherwise undetected toxins in cereals and animal feed, beyond that of the targeted analysis.
To download method and application notes for food and beverage analysis, please visit www.thermoscientific.com/fsnews
Food Safety Insider
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whats hiding
Contaminants emerge where they havent been seen before. New regulations are enacted, raising the bar on processes and suppliers. From arsenic in apple juice to bromate in bottled water, to fungicides in orange juice, the worlds leading beverage manufacturers and regulatory bodies trust us for the validated methods, sensitive, reliable instrumentation, and laboratory information management systems to ensure compliance and maintain the confidence of their customers. From our Food Safety Response Center, to our local expertise and support, were focused on ensuring the safety of the worlds beverages.
inside?
your global resource at thermoscientific.com/beveragesafety
Ion Chromatography
2012 Thermo Fisher Scientific Inc. All rights reserved. Copyrights in and to the beverage safety image
are owned by a third party and licensed for limited use only to Thermo Fisher Scientific by iStock.
ICP-MS
LC/MS
GC MS/MS
(continued from page 34)
PACKAGING
Software captures and links code data to establish parent/child relationships from primary container to pallet, organizes that information in a database and controls access to it. Although printing ranks as the most common method to add traceability information to pharmaceutical packaging, radio frequency identification (RFID) tags can also serve as the code carrier. However, RFID tags generally are viewed as too expensive to use on primary packaging. On the other hand, RFID tags can be scanned without being within the readers line of sight. In addition, some tags can be equipped to perform other functions. For example, tags for sensitive products could also monitor temperature and provide an alert if conditions exceed desired parameters during transport and storage of the product.10 Food packagers searching for ways to comply with FSMA should attend PACK EXPO International 2012 (October 2831, 2012; McCormick Place, Chi-
cago), where The Pharmaceutical Pavilion will serve as a source to evaluate and compare pharmaceutical equipment and practices and The Food Safety Summit Resource Center will offer food-specific references. In addition, the concurrent Conference at PACK EXPO includes tracks devoted to food safety and track and trace on Monday and Tuesday, October 29 and 30. n
Julie Ackerman is the senior director, public relations & communications, at PMMI.
References
1. fda.yorkcast.com/webcast/Viewer/?peid=8864 94cb24a741299e6a4578f40624721d. 2. Conroy, D. 2012. New training alliance targets food safety preventive controls. EAS News January. 3. Conroy, D. 2012. FSMAs schedule and animal feed. EAS News June. 4. Reynolds, P. 2012. Brave new world indeed. Packaging World April 23.
5. Lingle, R. 2012. Inspection: an inside look at package inspection in 2012. Food & Beverage Packaging May 16. 6. Spinner, J. 2012. PMMI leader shares perspective on global food supply chain. Packaging Digest March 28. 7. Forcinio, H. 2004. State-of-the-art packaging machines. Pharmaceutical Technology January:34. 8. Ohlsson, P. 2011. Equipment design and appropriate procedures improve cleaning, equipment and processing report. Pharmaceutical Technology December 21. 9. Department of Health and Human Services, U.S. Food and Drug Administration. 1997. 21 CFR Part 11, Electronic records; electronic signatures; final rule [Docket No. 92N0251]. Federal Register 62(54):1342913466. 10. Conroy, J. 2008. Cold-chain challenges heat up. Pharma-Bio Transport Winter. For more information on packaging, please visit www.foodsafetymagazine.com/ signature.asp.
The Insights You Need to Succeed In The Food Microbiology Testing Market
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By Jorge A. Hernandez
Every day, millions of cases of food products are produced, distributed and served safely, without incident or mention. Feeding 300 million Americans, and 7 billion people across the globe, is no easy task. It requires a complex system of growers, sellers, distributors, operators and consumers, and there are opportunities for improper handling to occur at every step. Even with one of the most advanced and refined food safety infrastructures in the world, contamination, unfortunately, remains inevitable. Recent foodborne illness outbreaks have caused some consumers to question the food they are purchasing. Many are condemning large-scale food producers, distributors and sellers, essentially swearing off the major food industry altogether. And while media attention focused on recalls raises consumer awareness of food safety, it also creates a myriad of problems for our industry, including loss of consumer trust, unwarranted regulatory concerns and the rapid spread of misinformation. One recent food trend is the demand for locally and organically produced foods. Some consumers perceive these types of products to be safer than others because they do not travel long distances, reducing the risk of contamination, but local and organic are words that define where and how the food is produced, not whether it is safe. Terms such as local, small farm and family-owned are not synonymous with safe. As evidenced by Jensen Farms, the cantaloupe grower responsible for last years Listeria outbreak, local, family-owned operations do not necessarily equal safety.
Media-generated food safety and quality issues have recently drawn attention away are waiting to see what the new legislafrom the legitimate concerns. One example is the recent consumer backlash over lean tion will require with regards to Hazard finely textured beef, dubbed pink slime by the media. The meat additive, commonly Analysis and Critical Control Points used in beef products and deemed safe by both industry professionals and govern(HACCP) and preventive controls, a ment entities, has no real bearing on food safety. In fact, its very safe. Nonetheless, cornerstone of FSMA. the issue grabbed headlines and increased a negative perception of the food industry The role of the U.S. Food and Drug as a whole. We took countless calls from concerned operators, consumers and even Administration (FDA) in shifting the parents who were worried about their chilfocus from contamination response to dren eating unsafe products. Its clear that prevention will be large, but the key is more education is needed on the difference collaboration. The only way to develop between legitimate food safety issues and attainable and realistic regulation is to media-generated ones. work directly with the food industry. This misinformation is only one of the Enacting widespread regulations withchallenges for food safety professionals. out stepping foot on a farm, into a canProgress as a whole is unlikely until the ning facility, onto a distribution truck or industry and its federal and state regulatory into a restaurants kitchen will only crecounterparts determine the real issues. And ate policies and rules that are unrealistic, though the adoption of the Food Safety unnecessarily expensive and unmanageModernization Act (FSMA) is aimed at able. Growers, suppliers and distributors preventing foodborne illness, food safety have vast reservoirs of knowledge that success will take more than regulation. can help the government establish safe So how do we make food safer? What processes and procedures without burconstitutes a safe food supply? And who is densome or unneeded regulations (see going to determine how successful we are? My Food Safety Philosophy: Its Just These are the questions that keep most of the Right Thing to Do, below). us in the food safety industry up at night. Regulation alone will not ensure the safety Heres my proposed solution. The first step of our food supply. Regulation will raise is ensuring that legislators and regulators have the proper tools to enforce food safety meathe floor for the entire industry, but the sures and enact policies that are mutually beneficial. Food safety professionals are the advancement of the industry depends experts. We need to be an integral part in the decision making. wholly on its leaders raising the ceiling to Then, leaders in the food industry need to come together and set the standard for create a new standard of safety. Those in food safety across the globe. There should be no trade secrets when it comes to food safethe food industry that have yet to make ty. It is up to the biggest and the best to not only change the perception of the food food safety a business priority will be industry, but also help regulators, legislators, consumers and other food companies required to comply as the new regulaunderstand the importance of safety. tions are implemented. This benefits And, finally, food companies need to take a larger role in the direction of food safety. Too everyone. often, food safety is seen as something mandated by governing bodies. Safety needs to My Food Safety Philosophy: be addressed by those doing business in the Its Just the Right Thing to Do industry; in addition to being financially Ive been working in the food industry for more than 20 years. At US Foods, Im responsible beneficial, it is just the right thing to do.
Recent foodborne illness outbreaks have caused
some consumers to question the food they are purchasing.
The Role of Legislators and Regulators

In January 2011, President Barack Obama signed FSMA in an effort to shift the focus from responding to food contamination to preventing it. This paradigm change brings regulation in line with what many food companies have already implemented. Though many proactive companies and food safety professionals are far ahead of the new regulations, there is still room for more action, more learning and more collaboration. Many in the industry
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for setting the food safety, quality and supplier sustainability vision and standards for the companys distribution centers, food processing facilities, logistics unit and private label products. In addition to my day job, I have a responsibility to the industry to help raise the floor for food safety. I deliver presentations at food safety conferences, sit on panels at industry meetings and have contributed to more boards than I can remember. Not because its in my job description, but because sharing best practices and promoting food safety makes all of us better at our jobs, it makes the food my family eats safer and it protects us from repeating critical errors. In all of my professional roles, there has been plenty of overlap, but perhaps the most important aspect of food safety I have learned is that it requires a great deal of collaboration. There are no trade secrets with food safety. Its imperative that we work together to ensure the safest food supply in the world. Its not only the best thing for your business, both operationally and financially, but its just the right thing to do.
ELEVATE
CONFIDENCE
Agilents comprehensive product and service solutions address the discovery and measurement of both chemical and biological contaminant analysis in current and emerging applications across the food spectrum. Were condent that Agilent is uniquely equipped to support food testing now and in the future. Access the new Food Safety Applications Compendium at: www.agilent.com/chem/food
IN FOOD SAFETY
Condence means knowing your lab is delivering accurate, consistent, and timely results. We listen carefully to customers needs, both present and future, engaging in lab-bench to lab-bench scientic collaborations to attack many of the food supply chains biggest challenges.
Food Safety Summit: Scan with your smart phone to register now.
Agilent Technologies, Inc. 2012
What does not benefit everyone is the exemptions the legislation provides for smaller producers. FSMA works against food safety protocol by selectively excluding farms and small processors depending on their size. When FSMA was planned, Congress worked hard to ensure that the new regulation did not come at the cost of burdening small farms with expensive food safety requirements, but in doing this, some of the most challenged facets of the food industry are being overlooked. It is those organizations that are too small to effectively manage their food safety systems that need the most help.
Role of Industry Leaders

Effective collaboration between industry leaders and regulatory agents will increase the safety of our food supply, and those in the food industry know that food safety does not stop at national borders. An increasing amount of the food we package and sell to our customers comes from outside the United States. In 1998, we imported $41 billion in food products. By 2007, that number had nearly doubled to $78 billion worth of food entering through over 300 ports. Nearly 15 percent of our food supply is imported, accounting for as much as 60 percent of fresh fruits and seafood. Working with international partners to ensure a safe nondomestic food supply is just as important as ensuring the safety of domestically grown and manufactured foods. Americans tend to think that food in the United States is safer than in the rest of the world. Its true that we may have one of the safest food infrastructures, but we also have more than 15 independent federal agencies enforcing food safety laws. Combine that with state agencies, public interest groups and the media, and you end up with a lot of different organizations trying to achieve the same goal but in different ways, which can cause some problems. Thats why its essential that food industry leaders work together (see Tom-a-to, Tom-ah-to: Sharing Differences for Global Safety, p. 59). Part of working toward a safer global food supply includes working closely with those in the international food industry. We need to create and enforce internationally recognized accreditation and certification programs to verify that suppliers around the world are using the latest food safety standards and best practices. Unlike other areas of your business, there should be no trade secrets in food safety. Sharing best practices and technology is too important to the overall strength of the industry and safety of the public. Two great examples of collaborative organizations include Global Food Safety Initiative (GFSI) and GLOBALGAP. The first of these, GFSI, pursues constant improvement in food safety management systems, cost efficiency in the supply chain and safe food for consumers worldwide. They work to scale existing food standards against food safety criteria and create mechanisms to exchange information in the supply chain, increase consumer knowledge and review existing food retail practices. The second, GLOBALGAP, sets voluntary standards for farm certification worldwide. The GLOBALGAP standard is designed to reassure consumers about how food is produced on the farm, ensuring food safety and animal welfare, minimizing environmental impacts of farming operations and taking a responsible approach to worker health and safety.
ELEMENTAL
Condence means conrming your total toxic and essential element results are accurate when you use advanced atomic spectroscopy technology to accelerate food screening. From labs large to small, from elements major to trace, Agilents leading portfolio of ICP-MS, ICP-OES, new Microwave PlasmaAtomic Emission Spectroscopy (MP-AES), and AA make food screening easy, results accurate, and analyses robust.
ACCELERATE
FOOD ANALYSIS
Media-generated food safety and recently drawn attention away concerns.
quality issues have
from the legitimate
For more information on the Agilent Atomic Spectroscopy Portfolio, visit: www.agilent.com\chem\ accelerate-food
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OPTIMIZE
ELEMENTAL
Condence means increasing accuracy and productivity by optimizing food testing performance with the best supplies for your atomic spectroscopy instruments. Maintain uptime for your lab with Agilents ICP-MS, ICP-OES, new Microwave Plasma-Atomic Emission Spectroscopy (MP-AES), and AA suppliesall engineered and manufactured to demanding specications under strictest conditions.
These groups are creating and implementing the most advanced global food safety standards and practices available. To do this, they create a dynamic system that can continuously monitor and confirm the safety of food from farm to fork. These tactics also utilize processes already established and administered by the International Organization for Standardization and are accredited in the United States by the American National Standards Institute.
Regulatory Collaboration
Outside of the industry, companies are working with regulators to collaborate on best practices. Tighter budgets have caused a reduction in FDA and U.S. Department of Agriculture staffing, affecting their bandwidth to learn about discrete industry segments and effectively develop food safety regulations. This makes it even more important that those of us in the food industry step in to help educate and assist regulators. US Foods recently hosted FDA in our facilities to demonstrate our processes and illustrate how our industry segment executes food safety protocols. Efforts like this fill the gap created by constrained resources. The time and assets we invested in implementing and testing food safety protocols in our more than 60 locations have produced a streamlined process that can be replicated throughout the industry. As food safety experts, we can help FDA and regulators identify the best ways to reduce contamination through the supply chain (Figure 1).
FOOD ANALYSIS
Supplier
Receives food safety and quality standards and guidelines on products and production from distributor.
Producer
Receives food safety and quality standards and guidelines on products from supplier.
Distributor
Intermediary between supplier and operator.
Operator
Sets food safety and quality expectations for distribution, receives guidance on best practices in return.
Consumer
Sets food safety and quality expectations for operator.
Figure 1. Roles of Food Supply Chain Members
Download or request a printed copy of Atomic Spectroscopy Supplies Catalog for Agilent and Varian instruments at: www.agilent.com/chem/ AtomicSupplies2
Another agenda item for food industry leaders must be increased certification in coordination with international standards. In addition to an audit, a third-party certification increases accountability and helps reassure consumers that food safety protocol is being followed. In February 2012, US Foods announced that it expects to be the first in its industry to be certified in food safety and quality to the International Features Standard (IFS), a globally recognized yardstick for safety and quality. Meeting that standard is a key milestone because nothing is more important to us than the safety, quality and integrity of the food we deliver to customers.
Role of Food Companies

As a food company, US Foods role is to demand the best products from suppliers and require that they utilize the best food safety practices. We need to continue our commitment to educating our customers, which includes restaurants, healthcare and hospitality facilities, government operations and educational institutions, on the best products, practices and certifications used to ensure the integrity of their products. Of course, we ensure the integrity of the products while in our custody, but when we sell them to a customer, we take it a step farther and educate them on how to prevent contamination in the kitchen.
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Visually, the distributors role looks much like a pyramid. At the top, the distributor determines food quality requirements with their suppliers and receives similar requirements from their customers. As the gatekeeper of the products, it is our responsibility to make sure that integrity is being upheld throughout the entire supply chain. In the rare instance that a food product needs to be recalled, it is essential to have proven technology available to trace and remove the recalled product. In 2010, US Foods invested in a new electronic recall management system called eRecall. The system automates the initial communication of the recall and recovery action in our distribution centers, tracks their response time and provides the centers with a list of customers who purchased the product of concern. When the recovery action is elevated to recall status, the system sends an initial communication to all affected customers via e-mail and voice message. It also tracks customer response to the messages and provides our staff with a list of customers who have not responded. We can then reach those customers directly by phone or in person, thus ensuring that all parties are properly informed. As an industry-leading food company, we need to continually enhance recall technologies and ensure that if a bad product is delivered to a customer, it is removed promptly and effectively. Just as our company is responsible for ensuring that a contaminated product is removed from the shelf, it is also our role to investigate the problem afterward and work to ensure that it does not happen again. Oftentimes, multiple parties are to blame for contamination. In this case, we demand accountability from suppliers who may have provided a bad product or the operator who may have mishandled it.
ENSURE
FOOD SAFETY
DATA INTEGRITY
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Creating a Food Safety Culture

Companies can have thorough, written HACCP plans and protocols, but without making constant implementation of those plans a business priority, they will fall short. Every food facility must create a food safety culture. At US Foods, we have worked to make food safety the first priority of our employees. Before an employee moves a single box of products, he or she must be properly trained.
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Tom-a-to, Tom-ah-to: Sharing Differences for Global Safety

Whenever a contamination or product recall occurs, it throws a spotlight on the food industry. Its important to ensure that when a recall occurs, we take the time to determine why it happened and how to prevent it from happening again. The Florida Tomato Exchanges Tomato Metrics meeting in Maitland, FL, earlier this year focused on how well food safety standards for the fresh-tomato supply chain have spurred effective food safety systems for tomato production and handling. Suppliers and distributors know the importance of implementing effective and preventative food safety protocols, and this meeting focuses on providing the fresh-tomato industry with analysis of recent recalls and future prevention strategies. Discussions with food suppliers at the event provided context surrounding past recalls and what organizations in the fresh-tomato supply chain can do to streamline and improve their food safety programs. We reviewed previous outbreaks and determined what went wrong before proposing targeted and effective solutions for prevention. One of the crucial aspects of a food companys job is to act as the gatekeeper between the producer and the plate. By reviewing previous recalls and defining a specific set of food safety protocols for the fresh-tomato industry, well be more effective at reducing the risk of contamination in the future. For more information about the meeting, visit www.floridatomatoes.org.
To learn about OpenLAB Informatics Suite in food safety, visit: www.agilent.com/chem/ensure
Agilent T echnologies, Inc. 2012
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We have expanded our training programs to focus on individual tasks each employee must perform as part of his or her job on a daily basis. We also have implemented a learning management system for the delivery of online training, through which we are able to identify training comprehension in key tasks areas by job or region. Consider regular training sessions and implementing a system to measure knowledge retention. The information we gather lets us modify the training to ensure better comprehension by job, specific distribution center or region of the country. Further, when the training data are connected with the data from second- and third-party audits, we can measure the impact of training on actual food safety performance of the facility. This allows us to better identify specific ways to improve food safety performance at the employee level. We also help our suppliers create a food safety culture. We regularly invite them to our facilities and provide education on our quality standards. Identifiers include the look, taste, color, weight and cut of the product. By hosting this training, we have seen a significant increase in the quality of the products we receive from our suppliers, and in some instances, we saw a 50 percent reduction in product rejections. As a food company, much of our work is focused on certifying facilities and demanding suppliers get certifications and adhere to strict standards. In the long term, certification equals standardization. The certification process requires facilities to provide proof of safe processes. By standardizing food safety, the entire supply chain can confirm that a facility is up to par and will not put their business, and more importantly, their customers, at risk (see Hot Trucks Investigation: Maintaining the Cold Chain, below). For this to work, we must create more awareness and engage in customer education campaigns about the importance of certification.
So how do we
make food safer?
It is essential to note that a food safety culture for an operator is different than for a supplier. For example, an operator should be much more focused on inspecting products upon delivery, safe handling and preparation of food materials, while a supplier would focus more on proper certifications and processes to ensure safe products. Your specific food safety culture needs to be clearly communicated to employees and customers.
Putting the Pieces Together

Food companies cannot wait for regulators to catch up with the industry and technology. As food safety professionals, it is our job to stay ahead of regulations and do what is necessary because it is the right thing to do, not because we are told to do it. As food consumers, we must demand a safe food source. Food safety is a commitment; its an investment of time and money, but a properly designed and executed food safety system will save you both in the long term. The first step is enacting rules and laws that are attainable and realistic. Leaders in the food industry must set the standard for food safety across the globe. This can be done through collaboration, both domestically and internationally. A number of organizations are working to increase the safety of our food supply. Consider lending your expertise to any one of these groups. Everyone in the food chain needs to take a larger role in the direction of our food safety practices and help shape where we are headed. Food safety cannot be something thats regulated. It has to be sparked internally by food businesses. The best investment in food safety your company can make is in its people. While you cannot regulate your way to food safety, you can train your team to put food safety before all decisions and actions. That creates a culture, and that culture produces safe food for all. n
Jorge A. Hernandez is the senior vice president, food safety & quality, at US Foods. He can be reached at 847.232.5959; jorge.hernandez1@usfood.com.
What constitutes a safe food supply? And who is going to determine we are? how successful
Hot Trucks Investigation: Maintaining the Cold Chain

A recent news investigation in Indianapolis followed police and local health department officials as they stopped a number of local and regional food distribution trucks. They found temperatures exceeding legal and safe limits for refrigerated and frozen food products. During the investigation, many drivers claimed they were unaware that the temperatures were not at a safe level. Some admitted that they knew, but were told by their company to keep the refrigerator off to reduce fuel expenses. Through this investigation, health department officials were able to partner with state police to ensure that any products not properly cooled would be destroyed. Operations like this illustrate how police and health officials are working close together to increase the viability of inspection programs. Food safety should be a top priority for every link in the food chain. Companies should utilize thermometers and time-temperature recorders to gather data that can be merged with GPS and IT systems to not only regulate temperatures of products in transit, but to also manage the cold chain during loading, unloading and delivering. Transporting food at incorrect temperatures is not only unsafe, its also illegal. In fact, the recent investigation led to Indianas consideration of a new law that would create a state body to enforce food transportation law.
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LOW-LEVEL ANALYSIS OF INORGANIC ARSENIC IN APPLE JUICE BY LC-ICP-MS

Trace Elements in Foods and Beverages
The presence of potentially toxic chemicals in foodstuffs is of intense public interest, and food producers and regulators strive to ensure that such chemicals are monitored and controlled at levels above where they might be harmful. In the case of some trace elements, such as arsenic (As), tin (Sn) and mercury (Hg), the elements chemical form (or species) has a dramatic inuence on toxicity, so simple quantication of the total amount of the element does not give sufcient information to assess food safety. For example, the inorganic forms of As arsenite (As(III) and arsenate (As(V)) are much more toxic than the common organic forms. For these elements, chromatographic separation of the different species followed by species-specic quantication using ICP-MS is now widely accepted as the preferred analytical approach. samples are shown in Figure 2, and concentrations for each species in all six apple juice samples are shown in Table 1. The results are corrected for the 2x dilution factor applied during sample preparation. From these results, it is clear that all the samples contained some inorganic As, but the levels were low (less than half the USEPA limit for drinking water).
Concentration (ug/L) Sample Name Dilution Apple Juice 1 Apple Juice 2 Apple Juice 3 Apple Juice 4 Apple Juice 5 Apple Juice 6 2 2 2 2 2 2 AB 0.036 0.026 0.02 0.039 0.043 0.036 DMA 0.189 0.022 0.267 0.208 0.209 0.235 As(III) 0.724 0.041 0.883 0.992 1.256 1.098 MMA N/D N/D 1.587 1.466 0.785 N/D As(V) 0.651 0.058 0.758 1.958 0.709 0.068 Total Inorganic As 1.375 0.099 1.641 2.95 1.965 1.166
Arsenic in Apple Juice

Recently, concern has been expressed over the levels of inorganic As in apple juice, with some reports stating that the levels can exceed the USEPA limit for As in drinking water (10 ug/L or ppb). Arsenic in apple juice may be derived from the historical use of the As-based pesticides lead hydrogen arsenate and calcium arsenate. Widespread use of these chemicals ceased in the 1970s, but they are persistent and may still affect crops grown on contaminated land. In this study, we used an Agilent 1200 Innity LC coupled to an Agilent 7700x quadrupole ICP-MS to separate and measure the As species in six commercial apple juices purchased from a Japanese supermarket. The apple juice samples were prepared by simple ltration and a 2x dilution in deionized water, ensuring that species inter-conversion was minimized and detection limits were maintained. The species of interest, As(III), As(V) and the organic forms arsenobetaine (AB), dimethylarsinic acid (DMA) and monomethylarsonic acid (MMA) were separated using an Agilent anion exchange column.
Table 1.
Concentrations of ve As species in six apple juice samples. N/D: not detected
Figure 2. Overlaid chromatograms of As species in four apple juice samples
Low-ppt Level Analysis of As Species

The data presented here demonstrates that the Agilent 7700x ICP-MS is suitable for the analysis of As species at low 10s ppt levels in apple juice. The simple sample preparation, low dilution and rapid, reliable chromatographic separation ensure that this method is suitable for routine monitoring of As species in beverages. The same apple juice samples were also measured using this LC method coupled to the Agilent 8800 ICP-QQQ, which provides higher sensitivity than the 7700 and therefore somewhat lower detection limits. The 8800 data is presented in Agilent Application Note 5991-0622EN. For more information on the 7700 Series visit the Agilent Technologies web site at: www.agilent.com
Figure 1.
Calibrations for As(III) and As(V) from 10 to 500 ng/L (ppt)
Calibrations for the toxic inorganic As species are shown in Figure 1. The calibration range was from 10 to 500 ng/L (ppt) illustrating the good sensitivity and linearity at these sub-ppb levels. Overlaid chromatograms for four of the
Category: EGGS
By Patricia Curtis, Ph.D., and Jacqueline Kochak
A
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Making the Case for Caging: Improvements in Egg Safety and Animal Welfare
Knowledge ensures that best possible results can be achieved
nella also can be found inside eggs that appear perfectly normal, which is why consumers are warned to never eat raw or undercooked eggs unless they are pasteurized. Today, on average, one out of every 20,000 chicken eggsany kind of eggscould contain a small amount of Salmonella deposited into the egg as it passes through the oviduct.2
After more than half a billion shell eggs were recalled nationwide in 2010 because of concerns about Salmonella contamination, some consumers embraced the idea that organic and free-range eggs must be safer. A dozen large organic eggs cost almost twice as much as a regular carton of eggs, but that didnt stop shoppers. Press reports and organic enthusiasts started touting the safety of specialty eggs, claiming sales increases. Then in 2011, the U.S. Food and Drug Administration (FDA) reported the recall of organic eggs produced by a Minnesota farm and distributed to restaurants, grocery stores, food wholesalers and foodservice companies in Minnesota, Wisconsin and Michigan. In fact, Salmonella is a risk in all eggs, whether they are organic or free-range, whether they are white or brown or blue, or whether they are nutritionally enhanced like omega-3 eggs. In fact, the typical egg that looks clean at the farm actually has about 10,000 colony-forming units (CFU) of Salmonella on the shell before washing, even at a well-managed facility.1 Salmo-
How Salmonella Infects Eggs
Salmonella lives in the intestinal tracts of animals and birds, and before the 1970s, direct fecal contamination of eggshells was the most common source of Salmonella infection associated with eggs. In the 1970s, as salmonellosis began to emerge as a public health problem, stringent procedures for cleaning and inspecting eggs were implemented, and salmonellosis caused by external fecal contamination of eggshells is now extremely rare. In the late 1970s and early 1980s, however, researchers discovered that Salmonella Enteritidis could infect the ovaries of
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Category: EGGS
healthy hens and contaminate eggs before the shells formed. Chickens harbor Salmonella without any sign of illness, making it impossible to pinpoint which hens are infected. Unlike eggborne salmonellosis of past decades, the 2010 epidemic was due to intact and disinfected grade A eggs. Chickens can pick up Salmonella from feed or from some other source in their environment, which can be contaminated by rodents, flies and other birds if the producer is not diligent about sanitation. If a contaminated egg is laid, it usually contains only a very small number of Salmonella, but under ideal conditions, Salmonella doubles every 20 minutes. Eggs that arent cooled quickly can harbor millions of bacteria in just 8 hours. other hens, serious injuries and cannibalism sometimes result. Battery-caged hens peck and cannibalize less, which is one of the reasons the cages became standard in the industry. In fact, the mortality rate for hens was about 40 percent annually back in the 1920s and 1930s, when egg production was a backyard industry. The combination of specially designed indoor housing and cage systems has reduced the annual mortality rate of hens to just 5 percent.3 These cage systems reduce Salmonella infection through the shell, because eggs are laid on the sloping floor of the cage, with minimal contact between the egg and the hen, decreasing the possibility of bacterial contamination. Confinement and caging of hens also keeps hens away from their droppings and
Chickens can pick up Salmonella from feed or from some other source in their environment, which can be contaminated by rodents, flies and other birds if the producer is not diligent about sanitation.
Salmonella also can be introduced through the shell, because an eggshell contains some 9,000 microscopic pores where Salmonella can get in from a contaminated conveyor belt or even a vat of contaminated egg-cleaning liquid. As noted, the typical egg, even at a well-managed facility, has thousands of Salmonella CFU on the shell before washing. After the egg is washed, there will be fewer than 20 CFU on the shell. Eggs contaminated by fecal matter, however, have far more CFU and could still have high CFU after washing. the pathogens in the droppings, making it possible to dispose of droppings more easily. Consumers can probably be forgiven for mistakenly associating an increase in salmonellosis with the rise of large farms utilizing battery cages, but professionals should not make that mistake. Many of the appalling conditions shown in animalrights videos are caused by human cruelty and managements failure to follow existing regulationsnot because of the housing system. The former egg mogul whose farms produced the shell eggs implicated in the 2010 outbreak had already paid millions of dollars in fines for numerous violations. At the Iowa farms involved in the outbreak, inspectors found dung heaps eight feet deep in some barns, with manure overflowing and bursting through doors. Escaped chickens scratched loose in the filth, and flies and maggots were everywhere, according to the FDA inspection report.4 Because chickens pick up Salmonella from their environment, filthy surroundings increase the risk that the bacterium will be introduced into a hens oviduct and infect the eggs. Salmonella is also more likely to infiltrate the shell through the microscopic pores when overall conditions are unclean. Many large farm operations are clean and well run, however, and turning back the clock to a time when hens were not confined will not solve the Salmonella problem. Organic, cage-free and free-range eggs are produced for a niche market of consumers concerned about animal welfare, but the eggs taste the same, are the same quality and are no more assured of being free of Salmonella than traditional eggs. They are always more expensive than eggs produced in the conventional manner. First, some definitions: Cage-free: Hens living in indoor-floor facilities produce cagefree eggs. These hens do not necessarily have access to the outdoors but may have access to a multitiered indoor environment
Egg Production Systems

To understand why any kind of egg can be infected with Salmonella Enteritidis, it is important to know something about how different kinds of eggs are produced. Today, the vast majority of hens are housed in large laying facilities using cage systems called battery cages. The birds are protected from the elements, disease, predators and accidents and provided with optimal temperature, humidity, feed, water, laying space and security. Human working conditions are often better at farms that use cages, because there is usually less dust and ammonia and it is possible to automate egg collection. It is also possible to control the hens diet, resulting in better-fed hens that produce higher-quality eggs. Hens that live in these cages produce some 95 percent of the eggs consumed in the U.S. This traditional housing, which first became prevalent in the 1970s, has gotten a bad name among animal-rights activists because hens are confined in close quarters. When battery cages were first introduced in the 1930s, however, they were considered progressive and more humane than earlier methods because hen mortality dramatically decreased. This is partly because of the hen behavior that gave rise to the term pecking order. More dominant, aggressive hens peck at other hens and keep more timid hens from getting to the feed. As a hen starts pecking and pulling at the feathers of
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Category: EGGS
called an aviary. As noted, mortality rates may be higher because the hens tend to peck at each other, causing injury. Cagefree hens also are subject to hen hysteria, the panic behavior that causes them to pile on top of one another, smothering hens on the bottom. Hens laying cage-free eggs theoretically are able to walk, spread their wings and lay their eggs in nests. United Egg Producers guidelines for cage-free hens call for at least 1.5 square feet of space per bird, although this can be lowered to 1 square foot depending on the kind of facility and hen. Birds that lay brown eggs, for example, are bigger than birds that lay white eggs and require slightly more space. eggs, which are laid by cage-free hens in a barn setting, and eggs laid on the range have a greater chance of coming in contact with Salmonella in the nest or soil and in fecal matter. Agricultural Research Service food technologist Deana Jones and her team in the federal agencys Egg Safety and Quality Research Unit compared environmental and egg microbiology for laying hens in conventional cages and freerange sister flocks, and found no difference in the incidence of Salmonella in the two systems.5 The study actually found more Campylobacter in the free-range production environment than in conventional cage environments. Campylobacteriosis is
There is actually greater potential for inadvertent contamination in cage-free and free-range production systems, because Salmonella is found widely in natureeven in the soil.
Free-range: Free-range eggs are produced by hens with access to the outdoors, but this does not mean they are always kept outdoors. They might be kept in a combination of a barn and outdoor pens called verandas or porches. Typically, they are kept inside at night for protection from the elements and predators. There is no consensus on how much land per bird constitutes a range, and there are no set standards for free-range eggs or mandated third-party auditing. Pasture rearing of chickens is a modification of the free-range system. The hens remain on the pasture all the time, but are confined in a portable pen that is moved to give birds access to fresh pasture. Often, the names pasture and range are used interchangeably. Organic: Eggs labeled organic are produced by hens whose feed does not contain most conventional pesticides, fungicides, herbicides or commercial fertilizers. The feed is vegetarian and must be certified organic. Hens that lay eggs labeled organic also must be free to range outdoors. These hens do not receive growth hormones or antibiotics either, but it is illegal to use any kind of hormones in U.S. commercial egg production, and antibiotics are used only to treat sick birds. Labels touting no hormones are misleading, implying that other egg products may contain hormones. The National Organic Standards Board, appointed by the U.S. secretary of agriculture, has established guidelines that must be met by producers who say their eggs are organic. Producers using the word organic earn certification from the U.S. Department of Agricultures (USDA) National Organic Program, although producers with sales of less than $5,000 are exempt from certification. All Natural on a label is meaningless, because all eggs are natural. the most common cause of diarrhea in the U.S., and the U.S. Centers for Disease Control and Prevention estimates there are more than 2 million cases of the illness from various sources each year. Campylobacter is naturally occurring and was detected in the environment, not in the eggs, and egg consumption is only occasionally the cause of campylobacteriosis. Listeria also was detected in both environments, again with no difference in prevalence between conventional cages and free-range environments. Fortunately, there have been no documented outbreaks of listeriosis from consumption of eggs or egg products, but studies have detected Listeria in raw egg samples. Healthy people may not get sick from eating eggs contaminated with Listeria, but people with weakened immune systems, the elderly and pregnant women need to be especially careful that their eggs are cooked.
A Comparison
Because of the controversies surrounding battery cages in egg production, the American Veterinary Management Association (AVMA) in 2010 released a report on the welfare implications of various kinds of housing.6 The report concludes consumers need to balance the hens freedom against exposure to potential hazards such as disease vectors and the cannibalism caused by pecking. Some highlights of the AVMA report: The overall mortality rate is better for hens in conventional cages and worse for cage-free and free-range hens. Mortality from feather pecking and cannibalism is less in conventional cages. Hens in conventional and furnished cages are exposed to fewer disease vectors, such as wild birds. They are also exposed to fewer internal parasites. Free-range hens are exposed to the most disease vectors and parasites. There is less hen hysteria in conventional cages and small to medium furnished cages. Piling on and smothering of other hens is less likely to happen in a conventional cage system.
Safety Risks
There is actually greater potential for inadvertent contamination in cage-free and free-range production systems, because Salmonella is found widely in natureeven in the soil. Floor
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Category: EGGS
On other hen welfare measures, the ratings are opposite. Conventional cages rate as poor on use of nest boxes, use of perches and dustbathing behavior. Dust bathing involves tossing and rubbing dust between the feathers to maintain feather and skin condition. Air qualitythe presence of dust and ammoniais best with conventional cages and free-range systems. While this is not
Other Specialty Eggs

There are numerous other kinds of eggs that fall under the category of specialty eggs, but the same safety considerations apply to these eggs as to any other eggs. Brown eggs, of course, are not really specialty eggsthe only difference between brown eggs and white eggs is that brown eggs are produced by hens that have red feathers and red earlobes, such as Rhode
The new FDA Egg Safety Rule, specifically aimed at reducing human Salmonella infections caused by eggs, requires producers to be more fastidious about cleaning and disinfecting henhouses and getting eggs into refrigerators within 36 hours after laying.
a safety factor in egg consumption, it is a safety factor for those who work on egg farms. Cage-free and free-range eggs cost more because these husbandry systems are labor intensive, and feed intake is usually greaterespecially in cold wintry monthsbecause the environment is less controlled. For consumers concerned about laying hens closely confined in pens, paying more may be an acceptable trade-off, but the not necessarily 1/2 page Horizonal 7eggs x 4 are 7/8 - 1/8 Bleed safer. Island Reds and Plymouth Rocks. Hens with white feathers and white earlobes, such as the White Leghorn, lay white eggs, and the chickens preferred by commercial growers just happen to be white. The more exotic blue Araucana eggs are produced by the Araucana breed, which comes from Chile. Like brown eggs, these blue eggs are nutritionally identical to white eggs and subject to the same risk of Salmonella. Several kinds of specialty eggs are differentiated by the diets the hens eat. Vegetarian eggs, for example, are produced by
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Category: EGGS
hens whose feed is free of animal by-products, while omega-3 eggs are produced by hens fed a diet containing ingredients such as ground flaxseed, marine algae or fish oils rich in this desirable fatty acid. Like omega-3 eggs, lutein eggs are laid by hens fed a specially formulated diet, in this case, a diet including marigold extract. Lutein has been shown to reduce the risk of macular degeneration, the leading cause of blindness in the elderly. Eggs labeled as having lower fat and lower cholesterol also are produced by hens fed an altered diet, the only way so far to affect an eggs cholesterol content. It is interesting to note that Ken Anderson, a poultry scientist at North Carolina began vaccinating in large numbers. Last year, according to data from the Health Protection Agency of England and Wales, there were just 581 cases, a drop of 96 percent from 1997.8 One-half to two-thirds of American producers already inoculate their flocks, according to industry estimates, but FDA declined to mandate vaccinations in its new Egg Safety Rule, saying there was not enough evidence to conclude that vaccinating hens against Salmonella would prevent human illness. FDA has estimated the cost to farmers at about 14 cents a bird to vaccinate, or about $31 million to cover hens at all large farms in the country. Vaccine company executives dispute that
Scientists are also working on new techniques to promote egg safety, such as a Salmonella vaccine for chickens, already in use in Europe.
State University, has established there is no difference between the cholesterol in conventional eggs and free-range eggs, despite news reports to the contrary.7 Pasteurized shell eggs are considered specialty eggs. This is the only category of eggs with a different food safety profile, because these eggs have been heat-treated to kill potential Salmonella. Pasteurized shell eggs have only been on the market since the 1990s, when the patented method was developed, and are a good choice for recipes such as Caesar salad or homemade ice cream requiring raw eggs. Pasteurized eggs are coated with food-grade wax to prevent recontamination and stamped with a red P in a circle to distinguish them from other eggs. figure, saying the cost can be just a few cents a bird. A single bird can lay about 270 eggs in its lifetime.8 The future of hen vaccination in the U.S. might take the same course as vaccination efforts in the United Kingdom. There, vaccination is not mandated, but the countrys major supermarkets buy only eggs carrying an industry-sponsored red lion stamp that assures the public they have met basic safety standards, including vaccination. Some 90 percent of egg producers meet the standards to utilize the stamp, according to The New York Times.8 Another promising method of controlling Salmonella is a patented process that involves rapidly cooling eggs so the Salmonella bacteria do not multiply to dangerous levels. The rapid-cooling process, developed by poultry scientists at North Carolina State University, uses liquid carbon dioxide to stabilize the proteins in egg whites so much that they could be rated AAthe highest grade for eggsfor 12 weeks.9 Eggs cooled under current methods lose the AA grade in about 6 weeks. The rapid cooling also maintains the membranes surrounding the yolks for 12 weeks, which is significant because the membrane keeps harmful bacteria from reaching the nutrient-rich yolk. Earlier research showed the same cooling technology could significantly reduce occurrences of Salmonella illnesses. The rapid-cooling technology takes liquid carbon dioxide and turns it into a snow to rapidly lower the eggs temperature. Eggs are placed in a cooling chamber and carbon dioxide gas at about minus 110 F is generated. The cold gas circulates around the eggs and forms a thin layer of ice inside the eggshell. After treatment, the ice layer melts and quickly lowers an eggs internal temperature to below 45 F, the temperature at which Salmonella can no longer grow. Traditionally, the temperature of eggs when they are placed into the carton tops 100 F. Thirty dozen eggs are then packed in a case, and 30 cases are stacked onto pallets and placed in refrigerated coolers. The eggs in the middle of the pallet can take up to 142 hoursnearly 6 daysto cool to 45 F. A 2005 FDA/USDA Shell Risk Assessment report showed that if eggs were cooled and stored at 45 F within 12 hours of laying,
The Future of Egg Safety

Eggs are still relatively safe and getting safer. The new FDA Egg Safety Rule, specifically aimed at reducing human Salmonella infections caused by eggs, requires producers to be more fastidious about cleaning and disinfecting henhouses and getting eggs into refrigerators within 36 hours after laying. Egg producers must buy chicks and young hens only from suppliers who routinely test for Salmonella, and egg producers also must have a written Salmonella prevention plan and maintain records documenting their compliance. Starting in July 2010 in the middle of the massive egg recalllarge producers were required to implement the rule. These large producers, consisting of operations with 50,000 or more laying hens, represent about 80 percent of the producers in the country. Smaller producers (those with at least 3,000 laying hens) were expected to comply by July 2012. FDA officials estimate that contaminated eggs cause an estimated 142,000 illnesses in the United States annually, a number they say will be cut in half by the new rules. Scientists are also working on new techniques to promote egg safety, such as a Salmonella vaccine for chickens, already in use in Europe. When the vaccine was introduced in England and Wales in 1997, there were 14,771 reported cases of the most common type of the bacteria, Salmonella Enteritidis PT4. Vaccine trials began that year, and the next year egg producers
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NJ_CC Ad_3x4_2012.QXD_NJ_CC Ad_3x4_2012 5/1/12 7:06 AM
Category: EGGS
there would be about 100,000 fewer Salmonella illnesses from eggs in the nation each year, with no difference in quality.10
Conclusions
Eggs in general have an excellent shelf life, whether they are white, brown or organic. Conventional eggs are on the store shelf for about 12 days from the date they are packed at the producers farm, and specialty eggs are usually kept on the shelf about 5 days longerso if an egg is infected, there is a little more time for Salmonella to multiply if not refrigerated correctly. But when kept in the egg carton, clean eggs free of cracks will keep for months. The important thing to remember is that despite occasional claims to the contrary, specialty eggs are no safer than conventional eggs, and all eggs are relatively safe. USDA research has shown there are no substantial quality differences among traditional, cage-free, free-roaming, pasteurized and nutritionally enhanced eggs. Only pasteurized eggs are safer than traditional eggs. The effects of alternative egg production systems on food safety are not completely understood, but research is being conducted. n
Patricia Curtis, Ph.D., a poultry scientist, is director of the Auburn University Food Systems Initiative (AUFSI), an interdisciplinary multi-institutional program integrating research, outreach and academic efforts to enhance the safety of the nations food supply from producer to consumer. One of AUFSIs activities is preparing food safety training for FDA inspectors at all levels. Jacqueline Kochak is communications director for the AUFSI.
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1. Soliour, G., M. A. Assanta, S. Messier and M. Boulianne. 2004. Efficacy of egg cleaning compounds on eggshells contaminated with Salmonella enterica serovar Enteritidis. J Food Prot 67(4):706712. 2. www.incredibleegg.org/egg-facts/egg-safety/eggs-and-food-safety#5. 3. www.aeb.org/egg-industry/egg-industry-evolution. 4. abcnews.go.com/WN/salmonella-egg-recall-federal-officials-outlinedisgusting-conditions/story?id=11518519#.T999aGBgMZ0. 5. Jones, D. R., K. E. Anderson and J. Y. Guard. 2012. Prevalence of coliforms, Salmonella, Listeria, and Campylobacter associated with eggs and the environment of conventional cage and free-range egg production. Poult Sci 91(5):11951202. 6. www.avma.org/issues/animal_welfare/cage_noncage_systems.asp. 7. Anderson, K. E. 2011. Comparison of fatty acid, cholesterol, and vitamin A and E composition in eggs from hens housed in conventional cage and range production facilities. Poult Sci 90(7):16001608. 8. Newman, W. 2010. U.S. rejected hen vaccine despite British success. New York Times. Aug. 24. 9. Curtis, P. A., K. E. Anderson and F. T. Jones. 1995. Cryogenic gas for rapid cooling of commercially processed shell eggs prior to packaging. J Food Prot 58(4):389394. 10. www.fsis.usda.gov/PDF/SE_Risk_Assess_ExecSumm_Oct2005.pdf.
References
REFORMULATION
By Evangelia Komitopoulou, Ph.D., and Paul A. Gibbs, Ph.D.
M
70
The Pitfalls of Product Reformulation and How to Avoid Them

Highlighting major product reformulation challenges
preservation. Both sugar (generally sucrose but also glucose-fructose syrups) and salt (sodium chloride) contribute to food preservation by reducing the water available to microorganisms for their growth (reduced water activity, aw), as well as to taste perceptions in many foods. As the aw is lowered with salt or sugars, organisms become dehydrated and their metabolic processes struggle to work efficiently. Organisms may synthesize compatible solutes that enable them to balance the difference in aw inside and outside the cell. However, such synthesis requires the cell to use energy it would otherwise use for growth, so growth rate is slowed or inhibited. If growth rate is further stressed, for example, by low pH or inhibitory agents such as nitrite and polyphosphates, then growth may be totally inhibited and the food becomes shelf stable. While the levels of inhibitory agents individually may be high to achieve shelf stability and safety, the combination of these hurdles to growth can lead to additive or synergistic effects with lower levels of each agent. Low pH combined with low aw and hot filling in jams and preserves prevent the growth of bacteria and even many yeasts and
Manufacturers often reformulate their products in response to changes in the price of ingredients, availability of usual supplies or, more recently, government or consumer demands for reduced sugar, salt or fat, or the omission of chemical preservativesa perceived healthier alternative. The way that all these trends overlap, for example, products promoting health and well-being with low sugar, fat and salt levels, highlights the major product reformulation challenges most companies face. Reformulating with entirely natural ingredients while maintaining product taste, texture, appearance, functionality, safety and shelf life, and remaining price competitive, can be a major task.
Shaking Up the Sugars and Salts

Although admirable in intention, any changes in those factors that contribute to food safety, stability and quality have in the past, and can still cause, problems in some food industry sectors. Even small changes in formulations can lead to unexpected problems in safety and stability; examples include changes in the levels or types of sugars or salt used in food
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REFORMULATION
molds. However, if the sugar level is below approximately 65 percent (w/w) after opening the container, the product should be chilled to slow the growth of osmophilic yeasts and molds that may contact the producta look at product labels shows this is quite common now. The lowering of aw by either the addition of solutes (salt or sugars) or drying is affected by the number of molecules in solutiona colligative property. Grains and cereals are normally dried to below approximately 16 percent (w/w) moisture, which minimizes mold growth. However, moisture migration can occur between warm and cool areas in large silos, permitting mold growth in the areas of raised aw. If the aw is lowered by a certain concentration of glucose, the same weight of sucrose will not achieve the same lowering of aw, as the molecular effect. A combination of hurdles contributing to both stability and safety is exemplified in the preservation of mayonnaises, pickles and sauces: Low pH (by acetic acid), salt and sugar are combined in appropriate concentrations to result in a safe and stable product. Reformulating this type of product, affecting levels of acetic acid, sugars or salt, needs to also involve a proportionate increase in other preservatives to ensure the same degree of product safety and stability. There is an equation that describes the safety and stability of these types of products in terms of the oil-water ratio, pH and quantity of acetic acid, salt and sugars in a formulation2; manufacturers of these types of products should be well aware of its use in reformulation. Exchanging citric or lactic acids for acetic for reasons of taste in such products can lead to unstable and unsafe products, as
Even small changes in formulations can lead to unexpected problems in safety and stability
weight is greater and there will be fewer molecules in solution. This also occurs if the dextrose equivalent (DE) value of sugar syrup is loweredthere are fewer molecules of small-molecularweight sugars per weight of syrup. Lowering of the DE of a marshmallow mix has permitted the growth of osmophilic yeasts, resulting in exploding marshmallows. These yeasts then became established in the factory; even returning to the original high DE value syrup did not entirely cure the problemthe yeasts had become even more tolerant of low aw. Only full cleaning and a further lowering of the aw of the marshmallows permitted the production of a stable product. A similar problem arose when sucrose was replaced with sugar syrups containing glucose and fructose. Wild strains of Zygosaccharomyces bailii cannot ferment sucrose, so replacing sucrose with sugar syrup allowed these yeasts to grow and ferment, causing bottles of soft drinks and squashes to explode. Factory strains of this yeast then became capable of fermenting sucrose, so another method of preservation was needed; for a while, sorbates and/or benzoates were effective, but many strains of yeasts are now resistant to these preservatives. these alternative acids do not provide the same levels of antimicrobial activity. In Spain, during the crisis of Salmonella in eggs, recipes for mayonnaises promoting the use of lemon juice (citric acid) instead of vinegar (acetic acid) led to many cases of salmonellosis from mayonnaise-type products. At equivalent levels of citric acid to acetic acid, Salmonella can survive well, especially if the product is stored in chilled conditions, and can even grow at higher temperatures.3, 4 In cured meats, salt, nitrite and polyphosphates plus moderately low pH act together to prevent the growth of Clostridium botulinum. As there was some concern in the 1960s about the formation of carcinogenic nitrosamines by cooking bacon at high temperatures, it was proposed to reduce the levels of nitrite to only that needed to develop the typical color of cured meats, around 1020 ppm. However, a large multicenter research project in the 1970s1980s in the UK, investigating the levels of salt, nitrite, polyphosphate, pH and heat process for canned hams, clearly demonstrated that there were minimum levels of and interactions between these ingredients necessary to minimize the likelihood of growth and toxin production by C. botulinum. Mathematical models of botulism risk assessment, based on the levels of these components, were developed from the very large databases of the research programs.5, 6 However, it was only much later that research work conducted at Leatherhead Food Research showed the metabolic mechanisms of inhibition of botulinum growth and toxin production; nitrite inhibits the phosphoroclastic generation of large amounts of energy from the metabolism of sugars, releasing pyruvate in the process. The presence of salt required the generation of extra energy to synthesize compatible solutes and expel excess sodium ions, and this was denied by the presence of nitrite, so cells died. Clostridium needs to accumulate ferrous ions for inclusion in the electron transport proteins; ferredoxins, with which to generate energy, and the presence of polyphosphates make this much more difficult. Thus, there is an additive or synergistic
Preservative Balance Is Key

Fruit flavorings have three preservation characteristicslow pH, low aw (with sugars) and pasteurization to eliminate yeasts and molds. Nuts, however, have an intrinsically high pH value (~6.56.8). Replacement of sugar with an intense sweetener in a nut pure (for a low-calorie flavoring for yogurt) raises the aw considerably. Pasteurization of the product does not destroy bacterial spores, but these cannot grow at low pH and aw. Loss of the protective effect of both low pH and aw led to cases of botulism in the UK, from yogurt flavored with hazelnut pure.1 The high pH and high aw product would require a full botulinum cook for safety (121 C for 3 minutes). In combination, several preservative agents may be individually reduced, as there is often some additive or synergistic
72
REFORMULATION
effect of all these ingredients of cured meats, resulting in improved protection from botulinum growth. However, reductions in the levels of one or more items can result in unstable cured meats; there are still several cases of botulism in Europe each year, involving on-farm or artisanal cured meats in which salt and/or nitrite levels are inadequate; slow salt penetration combined with inadequate chill temperature control is often the fault recognized. There is a similar but simpler effect in salted and smoked fish, but in most European countries, nitrite is not permitted. The major antibotulinum preservation is by salt levels above 3.5 percent salt-on-water phase, attained by adding salt and drying/smoking as well as chilled storage. Again, if these conditions are not satisfied, there is a risk of botulism for consumers, as evidenced by cases in Eastern Europe and some Mediterranean countries. Listeria monocytogenes is another pathogen associated with cold-smoked fish (e.g., smoked salmon) and cheeses (mainly soft cheeses) and raw (unpasteurized) hams. This pathogen can grow at high salt concentrations [up to ~10 percent (w/v) salt-on-water] and at low temperatures, thereby posing a risk for these industry sectors. Proper pasteurization of raw milk and good hygiene during cheese manufacture and ripening can control this organism, but this is rather more difficult in coldsmoked fish processing due to the absence of a Critical Control Point that can be used to eliminate the organism. Changing the drying-smoking regimen can encourage the development of lactic acid bacterial flora that can inhibit L. monocytogenes. Addition of protective microflora producing antilisterial bacteriocins and previously isolated from cold-smoked salmon have been shown to minimize growth or eliminate this pathogen.7, 8
Risks of Reformulation
Product reformulation needs to start with thorough risk analysis, risk assessment and effective risk management. It is important that we get to know our product well and understand what each ingredient does and contributes in the formulation. Only then can we really know what the safety limits are and make sure that any proposed reformulation can deliver a safe and stable product. In many different foods, combinations of the intrinsic factors (pH, salt, sugar, preservatives) actively contribute to safety and shelf life. Changing, reducing or eliminating any of these factors must never be undertaken lightly, or there may be an increased risk of food poisoning and/or a reduction in shelf life (i.e., spoilage). The use of mathematical predictive models, such as in ComBase,9 can be a valuable tool to avoid major pitfalls in reformulation, but as the database and equations are still limited in their scope of organisms and preservative systems, it may be necessary to challenge-test with relevant organisms to
73
REFORMULATION
demonstrate due diligence in safe food manufacture and marketing. Guidelines for microbiological challenge trials in new product development currently available in the public domain involve a set of generic steps to follow in the preparation of challenge microorganisms, sample inoculation and result interpretation. Microbiological challenge testing requires specific skills, knowledge and expertise to ensure that all those factors able to affect microbial growth, survival and recovery in the product samples are taken into account and appropriately addressed. There is often confusion around the applicability of microbiological challenge testing versus shelf-life trials.10 In shelf-life analysis, the product is stored under normal conditions and analyzed over time to ensure that it is safe and stable. This approach assumes good manufacturing conditions under a Hazard Analysis and Critical Control Points plan, which would limit the chances of microorganisms, other than the products normal background flora (not pathogens), contaminating the product. Therefore, in shelf-life trials, one assumes that analysis will target the naturally present spoilage microflora growing during storage under stipulated conditions. On the other hand, challenge testing is designed to answer the question of whether the product could be safe and stable if accidentally contaminated with pathogenic or spoilage microorganismsthat is, whether a specific product formulation would favor or inhibit their growth. The aim of challenge testing is to simulate what could happen to a product during production, processing, distribution or subsequent handling by consumers following inoculation with relevant microorganism(s) and storage under the representative conditions, from production to consumption.11
cation and evaluation of novel and natural antimicrobial systems in food preservation. Evangelia has been actively involved in reviewing microbial recovery conditions following different stress applications with particular emphasis on dry environments and has managed a number of projects on microbial attachment on food contact surfaces and the role of quorum sensing on the initial steps of biofilm formation. Evangelia is a member of British Standards Institution AW9 Food Microbiology Committee, which produces and reviews standard microbiological methods in the UK and other European countries. Paul Gibbs, Ph.D., is a principal consultant in food safety with over 40 years of experience in food microbiology. Paul is a recognized expert in food spoilage/microbial taint problems, foodborne infections and intoxications including Clostridium botulinum, effects of recipe/ingredient and formulation changes on microbiological stability of foods. Paul has been the coordinator on several EU-funded projects on meat, fish, sous vide foods, bottled water and bacteriophage applications.
References
1. OMahony, M., E. Mitchell, R. J. Gilbert, D. N. Hutchinson, N. T. Begg, J. C. Rodhouse and J. E. Morris. 1990. An outbreak of foodborne botulism associated with contaminated hazelnut yoghurt. Epidemiol Infect 104(3): 389395. 2. CIMSCEE. 1992. CIMSCEE code for the production of microbiologically safe and stable emulsified and nonemulsified sauces containing acetic acid. Comit des Industries des Mayonnaises et Sauces Condimentaires de la Communaut conomique Europenne, Brussels, Belgium. 3. Perales, I. and M. I. Garcia. 1990. The influence of pH and temperature on the behaviour of Salmonella Enteritidis phage type 4 in homemade mayonnaise. Lett Appl Microbiol 10:1922. 4. Xiong, R., G. Xie and A. S. Edmondson. 1999. The fate of Salmonella Enteritidis PT4 in homemade mayonnaise prepared with citric acid. Lett Appl Microbiol 28:3640. 5. Robinson, A., A. M. Gibson and T. A. Roberts. 1982. Factors controlling the growth of Clostridium botulinum types A and B in pasteurized, cured meats. V. Prediction of toxin production: Non-linear effects of storage temperature and salt concentration. J Food Technol 17:727744. 6. Jarvis, B. and A. Robinson. 1983. Predictive modelling of Clostridium botulinum toxin production in model cured meat systems. Leatherhead Food Research Association Research Report 414:128. 7. Tom, E., P. Teixeira and P. A. Gibbs. 2005. Anti-listerial inhibitory lactic acid bacteria isolated from commercial cold smoked salmon. Food Microbiol 23(4):399405. 8. Tom, E., P. A. Gibbs and P. C. Teixeira. 2007. Could modifications of processing parameters enhance the growth and selection of lactic acid bacteria in cold-smoked salmon to improve preservation by natural means? J Food Prot 70(7):16071614. 9. Baranyi, J. and M. L. Tamplin. 2004. ComBase: A common database on microbial responses to food environments. J Food Prot 67:19671971. 10. Komitopoulou, E. 2010. Microbial challenge testing. In Food and beverage shelf-life and stability, eds. D. Kilcast and P. Subramaniam. Cambridge, UK: Woodhead Publishing. 11. Notermans, S. and P. Int Veld. 1994. Microbiological challenge testing for ensuring safety of food products. Int J Food Microbiol 24:3339.
Design Matters
The trial design must consider such important parameters as the choice of challenge microorganisms, inoculum level and preparation, including preadaptation of the challenge microorganisms to the conditions applicable to the challenge matrix (e.g., adaptation to acetic acid conditions in a mayonnaise-type product), method of product inoculation and its effect on the intrinsic properties of the food matrix to be challenged, storage conditions of the challenged products and trial duration, microbial recovery conditions employed during storage and controls set alongside the inoculated samples. When these trials are designed to confirm the safety of new product formulations, when especially parameters such as levels of sugar, salt, acids and preservatives are affected, false results due to inappropriate trial design can significantly impact the reformulation process and safety of the final product. It is therefore recommended that the challenge trials be designed by expert microbiologists with years of experience and a solid record studying microbial physiology and behavior in foods. n
Evangelia Komitopoulou, Ph.D., is the head of food safety at Leatherhead Food Research. She is recognized for her involvement in the development and validation of microbial detection and antimicrobial assay methodologies as well as the identifi-
74
SPOTLIGHT:MEATANDPOULTRY
By Anne Rogan, Ph.D., R.D., C.D.N., and Eric Shelley
T
76
Building a Solid Foundation in Meat Processing and Preparation

Development of training curricula for meat safety
aging used for the processed meat, each part of the system must be held to high standards to avoid the contamination of meat with any biological, physical or chemical hazard. Some of the built-in safeguards in the meat industry include random testing for antibiotics by the U.S. Department of Agriculture (USDA) Food Safety Inspection Service at the slaughterhouses and the mandatory inspection of meat by USDA. New monitoring and tracking systems for animals through computer chip identification and purchasing seeds and feeds from USDA-approved sources provide additional protections for the farmer and consumer. The Food Safety Modernization Act (FSMA) signed into law in 2011 aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.2 Food safety concerns have increased with the globalization of the food supply. Often, outbreaks of foodborne illness are tracked back to ingredients grown in countries where there are fewer controls, lower standards of quality and less monitoring.3 International efforts to set standards for food safety are ongoing.
The State University College of Agriculture and Technology in Cobleskill, NY (SUNY Cobleskill) offers curricula in every facet of food production, giving students the opportunity to not only see but also experience the full cycle of food production from farm to table. The most important part of the SUNY Cobleskill students education is related to the safe processing and handling of food. Food safety overshadows all other quality factors. If the food is not safe to consume, it does not matter if the meat is tender, organic, dry aged, fresh, frozen or packed in gold foil! Over 76 million U.S. consumers become sick each year from foodborne illness. Over 300,000 of these individuals are hospitalized and 5,000 people die because of this illness.1 To emphasize the importance of food safety, four basic food safety principles are incorporated into the SUNY Cobleskill curriculum.
Principle 1: Providing meat to the consumer is no longer the responsibility of one individual or farm. Todays food production is a complex and interrelated system. From the grasses and forages animals are fed, to the pack-
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SPOTLIGHT:MEATANDPOULTRY
Principle 2: Microorganisms are ubiquitous and compete with us for their survival. Many bacteria require conditions around the body temperature of mammals to reproduce. For the meat industry, this means that as soon as an animal is harvested, the conditions are perfect for bacteria to reproduce in the meat. For this reason, food processors begin reducing the temperature of the carcass to below 41 F or colder as fast as possible. In the beef industry, special attention must be paid to Escherichia coli O157:H7
cooked and prepared before this time frame, consumers must know to freeze the meat. Although it is safe to freeze meat in the containers in which it was purchased, for long-term freezing, USDA recommends the use of freezer paper or aluminum foil or freezer-grade plastic. Lastly, providing consumers with safe thawing methods for frozen meats is important. The best way to thaw meat is in the refrigerator, which allows the ice in the meat to melt but prevents the meat from exceeding 41 F and entering the danger zone for bacterial growth.
Food safety concerns have increased with the globalization of the food supply.
and its relatives. These organisms can infect the intestines of humans if contaminated meat is consumed. The organism produces a toxin that causes bloody diarrhea, and in young children and the elderly, these infections can result in multiple organ failure. Some microorganisms are not pathogenic but cause food spoilage. These spoilage organisms cause economic losses throughout the food chain. Food production and preparation courses focus on these four food safety principles, promoting meat safety from farm to table. In all parts of the students education, a hands-on approach is taken in the instruction of food handling, preparation and safety. The campus meat processing laboratory operates under USDA inspection. Students witness a Hazard Analysis and Critical Control Points approach to meat processing and learn the importance of following Sanitation Standard Operating Procedures and Good Manufacturing Practices. They also learn the required record keeping that documents that critical limits are not exceeded, keeping product safe for commerce. SUNY Cobleskill has also started a Meat Processing and Food Safety certificate program. This intensive 1-month training is designed to give participants a solid foundation in meat animal harvesting, carcass breakdown and processing, food safety and customer relations. Graduates of this certificate program find employment in groceries, small processing plants, farmers markets, opening their own small plants and working in the culinary industry. In the culinary arts program, students are required to pass the National Restaurant Associations food safety course and exam. The curriculum for this course covers the basic concepts of food microbiology and the safe way to prepare food and clean and sanitize facilities used in food preparation. n
Anne Rogan, Ph.D., R.D., C.D.N., is professor of culinary arts, hospitality and tourism at SUNY Cobleskill. Eric Shelley is the meat processing laboratory manager at SUNY Cobleskill.
Principle 3: There is no substitute for cleaning, whether we are talking about a pasture, barn, food processing area or home or commercial kitchen. In addition to cleaning, sanitizing food contact surfaces and equipment is essential. Cleaning is defined as the removal of soil or dirt from an area or surface. Sanitizing is the reduction of microorganisms to very low levels. Routine cleaning around all farm and food production areas should be planned, scheduled and checked. Researchers are concerned with the potential residue that builds up in the crevices on the surfaces where the meat and food are prepared. There is interest in finding new sanitizers and methods for keeping the work surfaces impermeable so that they are easier to keep both clean and sanitized. Research efforts using nanotechnology to find solutions for cleaning and sanitizing problems on meat processing lines are ongoing.4 Principle 4: Consumers need to be educated regarding their responsibility for safe food. Many bacteria are destroyed by heating. For this reason, consumers need to know that the beef they purchase should be cooked properly before it is served. For most beef, this means bringing the roast or steak to 145 F and measuring the final internal temperature with a thermometer. Ground beef needs to be heat-treated to 160 F to be sure that its safe to eat. Eating undercooked beef is dangerous, so labeling the temperature for the final internal cooking temperature of all meat is important. Moreover, consumers must be given directions regarding the shelf life of fresh meat. Beef should be refrigerated as soon as possible after purchase. Fresh meat can be held in the refrigerator for 35 days at 41 F or below. Ground beef can be left at refrigerated temperatures for 12 days. If meat is not to be
78
References
1. Kutchler, F. 2007. Food safety: Overview. USDA, Economic Research Service, Washington, DC. 2. www.fda.gov/food/foodsafety/fsma/default.htm. 3. Onwulata, L., F. Flora and W. Kramer. 2008. Global opportunities in Agri-food science and technology. Food Technology 62:4147. 4. Goddard, J. 2011. Improving the sanitation of food processing surfaces. Food Technology 65:4046.
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Durex Industries recently introduced its new advanced Magnum family of cartridge heaters, which are manufactured using proprietary swage and compaction processes that processenable the design of high-watt-density heaters. The companys lean manufacturing processes and automation allow their cartridge heaters to provide state-of-the-art equipment for industrial electrical heating, temperature sensing and control.
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Aleco, a division of ES Robbins Corporation, has announced the launch of the AirFlow Mesh Insect Barrier Door, which allows air ventilation and keeps insects and debris out of the food work area while providing additional security. The door also provides a 65-percent shade factor that helps keep the facility cooler longer by significantly reducing solar heating while allowing in light. AirFlow helps meet U.S. Food and Drug Administration requirements, improves building appearance and is available in seven colors.
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Big Ass Fans has launched the Powerfoil X2.0 fan, created in direct response to requests from food facilities for a comfort solution that would also meet high facility standards. Features include a stainless steel wash-down motor built to withstand frequent intense cleaning, a completely sealed NitroSeal gearbox with food-grade oil and food-duty paint. Its stainless steel extension tube, mount and hardware are nonporous, nonabsorbent and corrosion resistant. Its design prevents the collection of food particles and the pooling of liquids for daily sanitation.
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Clear Lam Packaging Inc. has unveiled new packaging for the single-serve market, including the new Indulgence product line for the single-serve premium cupcake and muffin market. This gift box-style packaging features two-dimensional merchandising, with the contents inside easily viewed from the top or front. This product line is ideal for those who want to indulge in a sweet treat without the guilt of purchasing a whole cake.
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SANITATION
The presence of pestsdead or alive poses significant health risks. No matter the size or severity of an infestation, a pest problem is not a situation to be taken lightly.
Pest Management: An Absolute Necessity

In food manufacturing and storage facilities, pest management is accepted as a necessity. However, in practice, when every penny and every moment must be spent strategically, the necessary financial and time commitment given to proper pest management tends to fluctuate. The critical importance of pest management can sometimes be minimized and even rationalized away when there are budgetary decisions to be made regarding day-today operations. Yet a consistent focus upon developing a strong pest management programone that includes regular inspections and audits, proactive pestproofing measures and an immediate action plan to put in place when faced with a potential infestationis essential for providing consumers with safe and healthy food products. Corporate executives and food facility managers must ensure that all links within the food safety chain are properly maintained, with pest management a very important link. Strong pest management practices can often lay the foundation for overall best practices. When food facilities understand the threats posed by pests, acknowledge the significant contamination risks and fully recognize the value of being proactive in pest management, they can then achieve the benefits of operating at their safest and ultimately most efficient production levels.
Strong pest
management practices can often lay the
foundation for overall best practices.
Pest Management: Best Practices

Pest prevention works best when facility management and a pest manageAugust n September 2012
ment company form a partnership with one goalkeep the facility pest-free and ensure that the food produced or stored there is safe. The National Pest Management Association (NPMA) is currently revising its manual, Pest Management Standards For Food Plants, with a new edition expected in October 2012. The standards do not preempt local, state, provincial and/or federal regulations, but instead offer a road map for those pest professionals who service food processing and storage facilities. Any service provided must comply with government regulations or statutes governing pest management, safety and food protection. In addition, food plants may have requirements more stringent than these standards alone. Since facility managers are the first line of defense as they monitor potential entry points and signs of infestation, NPMA offers the following advice: Ensure the facility has adequate waste management systems inside and outside. Improper garbage disposal and overflowing and dirty dumpsters are sure ways to attract and breed pests. Seal all pest entry points around pipes, the foundation, loading docks and others. Ensure there are no leaks in the facility roof. Institute a no-prop door policy for employees. Install air curtains and/or screens to keep flying insects out. Install a gravel or rock perimeter around the facility to discourage vegetation growth that could invite and harbor pests. Maintain an 18-inch inspection aisle inside the facility. Keep pallets away from the walls and paint the aisle white so that pests and their droppings are easily visible. Eliminate clutter that pests could hide and nest in. Assess the type of outdoor lighting
used. Consider the use of sodium vapor lights to discourage pests that are attracted to light. Perform regular inspections of storage areas, equipment, drop ceilings, processing areas, locker rooms, windows and ventilation and laboratories for signs of insect or rodent infestations. Pest infestations that arise after companies forgo proactive prevention measures tend to wreak far more havoc, and they cost more to treat than the prevention program that may have staved off such pest problems.
The Bottom Line

While there is no guarantee against future outbreaks and product recalls, the Salmonella outbreak of 2009 offers a serious lesson for food manufacturers and for consumers. As food processing facilities reevaluate what safety means for their consumers and their business, pest management must be an important factor in the safety of both. No longer can pest management be relegated to a secondary priority, nor can it fall through the cracks of misunderstood standards, putting the lives and health of consumers at risk. Focusing on proper pest management programs will go a long way in keeping the companys reputation intact and its products safe for consumers. n
Jim Fredericks, Ph.D., is director of technical services for the National Pest Management Association. Missy Henriksen is vice president of public affairs for the National Pest Management Association. The NPMA, a nonprofit organization with more than 7,000 members, was established in 1933 to support the pest management industrys commitment to the protection of public health, food and property. For more information about pests and prevention tips, please visit www.PestWorld.org.
For more information on pest control in food facilities, please visit www.foodsafetymagazine.com/ signature.asp.
81
Focus on ALLERGENS
custard. If a server is unsure, a manager should be available to answer any questions without guessing. The most critical part of the equation is for the server to communicate the need for a special meal to the kitchen. Once the uncontaminated plate leaves the kitchen, it should be uncovered only in front of the diner. The server should confirm that it meets the patrons specifications and check back often to be sure. We were just trusting that people were listening to customers when they took the order, but once staff understood how important food allergies are, they were really positive about the training, Herman says.
Everybody on the Same Page

Once all the kitchen protocols are in place and all the staff has been trained, that should be enough, right? Not necessarily. Constant follow-up is vital. Students with severe food allergies have been covered by the Americans
with Disabilities Act since 1973, which means they are entitled to appropriate substitutions in school lunches. The Food Safety and Modernization Act (FSMA) of 2011 took the requirements further, authorizing the federal departments of education and health and human services to develop voluntary food allergy management guidelines for schools. Because peanut allergies can be life threatening, many schools now allow allergic students to carry their EpiPens rather than lock them up in the nurses office. Some have created nut-free zones in their cafeterias from which the humble peanut butter and jelly sandwich and PayDay bars are banished. But even these good intentions can go awry. For example, the parents of a kindergartner followed the American Dietetics Association rules and told the school nurse about their daughters peanut allergy; her doctor provided a dose of epinephrine to have on hand. The girl
knew she couldnt eat peanuts, but when she forgot her lunch at home, a cafeteria worker gave her a peanut butter sandwichand insisted she eat it. Turns out the nurse never communicated the girls allergy to the cafeteria, and that oversight sent a 5-year-old to the hospital in anaphylactic shock. [The 1946 National School Lunch Act, which requires schools to provide nutritious lunches to children in need] does not impose a statutory duty on the state to identify students with special dietary needs, develop a flagging regimen or otherwise guard against individual exposure to food allergens, wrote the appeals court judge in a ruling that let school officials off the hook for the incident. Thatthe awareness and ability to identify and accommodate students with dietary sensitivitiesis exactly what I hope the FSMA food safety guidelines on food allergy management will provide, even if they are voluntary. A good resource on the subject is available from the National School Boards Association, Safe at School and Ready to Learn: A Comprehensive Policy Guide for Protecting Students with Life-threatening Food Allergies. The report can be downloaded in PDF format at www.nsba.org/ foodallergyguide.pdf. As more schools look to outsource foodservice in the face of severe budget cuts, operations like Dions may have the opportunity to provide lunches to students. Its not clear how the federal food allergy rules will apply to them. We do some deliveries to high schools for resale in their snack bars, Herman says. Mostly weve been concerned about keeping things at the right temperature, but when it comes to food allergies, we make sure we have our proper ingredients list available. n
Betsy Craig is the chief executive officer and founder of Kitchens with Confidence LLC and brings more than 25 years of foodservice industry experience to her company MenuTrinfo LLC. Her goal is to ensure her clients meet or exceed new labeling regulations.
82
Advertisers Index
Abraxis, LLC 215.357.3911 www.abraxiskits.com................................. 79 Advanced Instruments, Inc. 781.320.9000 www.aicompanies.com................................................ 80 Agilent Technologies www.agilent.com/chem/food..................56-59, 61 Allied Blending and Ingredients 800.758.4080 www.alliedblending.com............................................. 69 American Proficiency Institute 800.333.0958 www.foodpt.com.... 23 Bia Diagnostics, LLC 802.540.0148 www.biadiagnostics.com............17 BioControl Systems, Inc. 800.245.0113 www.biocontrolsys.com. .... 25 CEM Corporation www.cem.com............................................................ 55 Covance Inc. 855.83MICRO www.nutri.covance.com........................... 9 EMD Millipore www.emdmillipore.com/foodsafety............................... 3 EtQ Management Consultants 800.354.4476 www.etq.com/foodsafety............................................... 5 FoodHACCP.com www.foodhaccp.com................................................... 83 Food Safety Connect www.foodsafetyconnect.com............................... 2 Hygiena, LLC 888.494.4362 ext 300 www.hygiena.com. .................... 63 Marel Inc. 888.888.9107 www.marel.com/usa. .................................... 29 Mettler-Toledo, Safeline, Inc. 800.221.2624 www.mt.com/pi...........21 Michelson Laboratories, Inc. 888.941.5050 www.michelsonlab.com............................................... 79 718.338.3618 www.MicroEssentialLab.com........................................ 67 Micro Essentials Laboratory, Inc.
Pickering_AminoAcid_FoodSafety.indd Pickering_AminoAcid_FoodSafety.p1 1 1 5/19/10 2:00:32 PM 5/18/10 5:43:25 PM
Microbiologics Inc. www.microbiologics.com....................................... 27 Microbiology International 800.EZ.MICRO www.800ezmicro.com................................................ 73 800.368.3043 www.meatassociation.com......................................... 75 NAMA E. Coli Conference Nelson-Jameson, Inc. 800.826.8302 www.nelsonjameson.com...... 69 Neogen Corp. 800.234.5333 www.neogen.com.............................. 1, 77 Pack Expo www.packexpo.com/food........................................................71 Pickering Laboratories, Inc. www.pickeringlabs.com.......................... 83 Q Laboratories, Inc. 513.471.1300 www.qlaboratories.com............... 82 R-Biopharm 877.789.3033 www.r-biopharm.com. ...............................15 Retsch 866.4.RETSCH www.retsch.com..................................................19 Roka Bioscience, Inc. 855.ROKABIO www.rokabio.com...............7, 65 Romer Labs Inc. 800.769.1380 www.romerlabs.com/allergens.........13 Strategic Consulting Inc. 802.457.9933 www.strategic-consult.com...........................................51 Thermo Fisher Scientific Inc. www.thermoscientific.com..............35-50 Thermo Fischer Scientific/Remel www.thermofisher.com/remel..... 84 Weber Scientific 800.328.8378 www.weberscientific.com.................11
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