Organic Testing: What You Need to Know

By Food Safety Tech Staff
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Are you interested in labeling your product as organic? This article provides a comprehensive guide to understanding the USDA’s requirements for organic testing.

According to the United States Department of Agriculture (USDA), Organic is a labeling term that indicates that the food or other agricultural product has been produced through approved methods that integrate cultural, biological and mechanical practices that foster cycling of resources, promote ecological balance, and conserve biodiversity. Synthetic fertilizers, sewage sludge, irradiation and genetic engineering may not be used. 

Where did the legal definition of organic originate from? The Organic Foods Production Act (OFPA), enacted under Title 21 of the 1990 Farm Bill, is the law that made “organic” a legal term. The intent of the OFPA of 1990 was to establish national standards for the production and handling of foods labeled as organic. The OFPA of 1990 authorized a new USDA National Organic Program (NOP) to set national standards for production, handling and processing of organically grown agricultural products. Additionally, the OFPA established the National Organic Standards Board (NOSB) which advises the Secretary of Agriculture in setting the standards upon which the NOP is based. 

The main goals of the OFPA of 1990 include:

  • Establish national standards governing the marketing of certain agricultural products as organically produced products; 
  • Assure consumers that organically products meet a consistent standard; and
  • Facilitate interstate commerce in fresh and processed food that is organically produced. 

What is the National Organic Standards Board?

The National Organic Standards Board (NOSB) is appointed by the Secretary of Agriculture, and is a Federal Advisory Committee comprised of the members listed below:  

  • Four farmers/growers; 
  • Three environmentalists/resource conservationists; 
  • Three consumer/public interest advocates; 
  • Two handlers/processors; 
  • One retailer; 
  • One scientist (toxicology, ecology, or biochemistry); and
  • One USDA accredited certifying agent.   

The responsibility of the NOSB is to recommend adding and/or removing materials from the National List (see next question). In general, synthetic substances are prohibited and non-synthetic substances are allowed. Additionally, the NOSB must review all materials every five years and recommend renewing, removing or changing each listing. The NOSB meets twice per year in a public forum to discuss the issues and vote on their final recommendations. All meetings are free and open to the public. Recommendations by the NOSB are not official policy until they are approved and adopted by the USDA. 

What is the National List?

A uniform National List of materials was mandated by Congress as part of the OFPA of 1990. The purpose of this list is to clarify which materials are acceptable and unacceptable to use in organic production, processing and handling in the United States. How has the Recent Final Ruling Published by the NOP on November 8, 2012, Affected the OFPA of 1990? On November 8, 2012, the NOP published a final ruling clarifying a provision of the OFPA of 1990 and the regulations regarding the requirement of periodic residue testing of organically produced agricultural products by accredited Certifying Agents. The final rule amends the USDA’s NOP regulations to clarify that “accredited certifying agents must conduct periodic residue testing of agricultural products that are to be sold, labeled or represented as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group (s)).” 

The final rule requires that Certifying Agents, on an annual basis, sample and conduct residue testing from a minimum of five percent of the operations that they certify. This action will help further ensure the integrity of products produced and handled under the NOP regulations.” The effective date of this final rule is January 1, 2013, and Certifying Agents must be fully compliant with the five percent requirement for the 2013 calendar year. The primary goal of this rule is to align the NOP regulations with the requirement for residue testing of organic products under the OFPA of 1990. Residue testing is a significant part of the organic certification process because it provides a quantitative means to monitor compliance with the NOP and discourages the mislabeling of agricultural products. 

Current methods of analysis for periodic residue testing

What are the current methods of analysis for periodic residue testing that meet the requirement of this recent ruling? The NOP uses monitoring data compiled by the USDA Agricultural Marketing Service (AMS), Science and Technology Program and United States state agricultural laboratories to evaluate the residual pesticides remaining on foods. The current method used to obtain this data is a modified QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) method. 

The NOP, USDA AMS and Science and Technology Program collaborated to create a “target” analyte list (NOP 2611-1) of all pesticides/metabolites/environmental contaminants that have been found in samples analyzed for the USDA Pesticide Data Program. Certifying Agents should use laboratories attempting to analyze as many compounds on the USDA’s Prohibited Pesticides for NOP Residue Testing list (NOP 2611-1). 

What are USDA’s laboratory selection criteria for testing organic products?

The criteria of the food testing laboratory that the USDA prefers a Certifying Agent performing the periodic residue testing for a Certifying Agent are listed below.

1. Laboratories should hold current accreditation to either: 

  • ISO/IEC 17025:2005, General Requirements for the Competence of Testing and Calibration Laboratories; or
  • An alternate standard approved by the NOP on a case-by-case basis. Certifying Agents should contact their NOP Accreditation Manager for additional information. A copy of the accreditation certificate should be provided to the certifying agent prior to shipping samples and should be attached to laboratory results when they are reported back to the Certifying Agent.  

2. Laboratories should participate in an international proficiency test program. A proficiency testing program is the determination of the calibration or testing performance of a laboratory by means of inter-laboratory comparison. A copy of the proficiency test results from the most recent round of proficiency testing should be available from the laboratory together with any corrective actions taken if the laboratory has failed the proficiency test.  

3. Laboratories should be capable of screening for the “target” analyte list of pesticides included on the document NOP 2611-1, analyzing the samples using gas chromatography (GC) and/or liquid chromatography coupled to a mass spectrometer (MS) or tandem mass spectrometer (MS/MS).  

4. Laboratories should provide evidence that their analytical method is appropriate for the submitted sample and that suitable validation data are available. Correspondence should be available to the certifying agent documenting that the method meets the laboratories’ minimum internal quality assurance requirements.

5. Certifying Agents should direct the laboratory to provide analytical results as follows:  

  • If no residue is detected, then the result should be provided as not detected (ND). The limit of detections should be provided.
  • If some residue is detected below the limit of quantification (LOQ), then the result should be provided as “Trace” or “BQL” (below quantifiable level). 
  • If residue is detected at or above the LOQ, then the result should be reported in parts per million 9ppm). Parts per million (ppm) is equivalent to milligrams per kilogram (mg/kg). 

References: 

  1. Federal Register Vol. 77, No. 218 Friday, November 9, 2012. Pages 67239-67532. Accessed at http://www.gpo.gov/fdsys/pkg/FR-2012-11-09/pdf/FR-2012-11-09.pdf on November 20, 2012.  
  2. Mary V. Gold. Organic Production/Organic Food: Information Access Tools. United States Department of Agriculture (USDA) National Agricultural Library. June 2007. Accessed at http://www.nal.usda.gov/afsic/pubs/ofp/ofp.shtml on December, 5 2012.  
  3. Organic Trade Association. Organic Foods Production Act Backgrounder. Accessed at http://www.ota.com/pp/legislation/backgrounder.html on December 5, 2012. 
  4. Public Law 101-624-November 28, 1990. Title XXI-Organic Certification. Accessed at http://nationalaglawcenter.org/assets/farmbills/1990-9.pdf on December 5, 2012. 
  5. United States Department of Agriculture (USDA) National Agricultural Library. Mary V. Gold. June 2007. Accessed at http://www.nal.usda.gov/afsic/pubs/ofp/ofp.shtml on December, 5 2012. 
  6. United States Department of Agriculture (USDA). NOP 2611 Laboratory Procedures for Residue Testing Rev02 November 08, 2012. Accessed at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5088988 on November 20, 2012. 
  7. United States Department of Agriculture (USDA). National Organic Program. Accessed at http://www.ams.usda.gov/AMSv1.0/nop on November 20, 2012.  
  8. United States Department of Agriculture (USDA). National Organic Program, National Organic Standards Board (NOSB) Accessed aton November 20, 2012.

Top 10 GFSI Non-conformances, and How to Avoid Them

By Michael Biros
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Are you ready for audit? Gary Smith, Director of training and improvement solutions at SAI Global, talks about the top 10 GFSI non-conformances for SQF & BRC audits.

1. Business Continuity Plan Components/Annual Testing and Review

Many companies do not know what a business continuity plan is. It is not a recall and performing a mock recall will not count as an annual test and review. It is the continuing of business with a disruption in the supply chain. What are your plans for a key supplier going out of business or being affected by a natural disaster? If there is a fire or accident at one of your facilities, how are you going to ensure that your customers will still get delivery of your product? 

2. Food Safety Plan

HACCP has been around for years, but this is still a major area of focus. HACCP must be implemented and individuals must be properly trained in HACCP. All Critical Control Points (CCPs) must be validated. Review supporting documents during annual check. Is the flow chart current? Is the hazard analysis still correct? Question your employees during your internal audit. Get your employees used to and comfortable with answering questions about the food safety plan. 

3. Equipment and Utensil Condition

Utensils (scoops, shovels, belts, etc), equipment, and all food contact surfaces must be designed and in good condition so as not to be a food safety risk. Implement a foreign material control plan. Have a preventative maintenance schedule. Focus the internal audit program on equipment, not just employees. Use a flashlight when conducting internal audits. Train, empower, and reward production employees to identify equipment defects. Do not have temporary repairs. 

4. Allergen Management

Allergens are the number one cause of recalls. You must have a good allergen control program and this program must be validated. Identify ingredients as allergens at receiving and have a label inspection program. Specific allergen proteins must be validated with surface testing and product testing. Allergens must be listed as hazards in hazard analysis with the control as the allergen management program. 

5. Internal Audit

Have a strong internal audit program that emphasizes proactive solutions to avoid non-conformances. Manage non-conformances with a corrective action program. Take photos of all findings during internal audits. Make the process as formal as possible. Dress like the auditor would and ask employees questions. 

6. Condition of Walls, Doors, Floors, and Ceilings

Tape, cardboard, and construction plastic sheeting must not be used as these surfaces cannot be cleaned. Doors and windows must be properly closed. 

7. Product Traceability and Mock Recalls

If an auditor asks you about a product, you must be able to list all the raw materials, where they came from, and how they were processed to create your product. Keep the recall team current. Have procedures for a mock recall and always perform it. Make the mock recall a real test. Include ingredients and packaging in all traceability programs. Perform product trace exercises during the internal audit. 

8. Records

Make sure that your records are legible, authorized, and that demonstrated activities are taken. 

9. Procedures for Product Disposition when Calibration is Out

This is a new standard. Companies are now required to have documented procedures in place for when calibration equipment is down. 

10. Stay Vigilant!

If you’ve achieved food safety certification, congratulations! However maintaining certification takes commitment and dedication. Be sure to maintain a strong food safety culture within your organization. Communicate well across all levels of the company. Have a strong internal audit program and don’t be afraid to identify issues and focus on corrective action management.

Future Demand on Food Lab Managers

By Sangita Viswanathan
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How will food labs meet the demands of the future? What role will FSMA regulations play? And how are labs dealing with globalization of the food chain?

Food labs – both within food manufacturing companies and external contract labs – are facing a multitude of challenges: Increasing regulatory changes and compliance pressures; greater volume of testing; newer technologies and testing methods; demand for faster, and more efficient results….. How are labs and lab managers keeping track of, and apace with, all these changes? 


David White, Chief Science Officer and Research Director at U.S. Food and Drug Administration (left, in the picture); Dave Evanson, President, EMS (middle); and Alvin Lee, Director, Center for Processing Innovation at the Institute for Food Safety and Health (IFSH), Illinois Institute of Technology (right), talked about these issues in a panel discussion moderated by Marc Carter, President of MC2, Inc. at Food Safety Tech’s Food Labs Conference organized last month in Chicago. We present some excerpts from the discussion below. 

 

What’s keeping you up at night?

Globalization of the food chain is a significant concern. FDA’s David White talked about the emphasis that FDA places on testing food products globally, increasing standards to get global labs on par with FDA’s accepted levels of testing, and using equivalent methods. 

“Southeast Asia and China, and the testing done in such regions, will be critical. This will need time and resources, but we should all collectively aim to get there,” White added. 

What keeps him up at night? White described that food labs of the future need to help companies be one step ahead of the next contamination. “Who would have thought about melamine, for instance? We need to consider which other products would be ideal for substitution and companies need to identify where their vulnerabilities lie. Everyone has a part to play in food safety – FDA doesn’t have the resources to do everything by themselves. Testing for the unknown, what’s the next melamine, that’s what keeps me up at night,” White explained. 

 

What’s the impact of FSMA regulations on the food lab market?

Getting labs to have in place specific food testing methodologies, HACCP and verification, plans to reduce contamination etc., will all improve under FSMA regulations. 

All these will take some time, says White, “but we are communicating to labs about where we stand and how the new rules can help take them to where they need to be.” 

IFSH’s Alvin Lee feels that there will be a lot more demand for documentation because of the new regulations: “Labs will have to establish certain processes or steps with a plan for preventive control, and find effective ways to control and manage data and documentation.” 

Echoing this sentiment, White said that labs need to figure out figure out how to manage databases more efficiently. “How do we create and store data, and produce it in a format that’s user-friendly? All these will be key challenges,” White described. 

 

How do food labs manage data currently?

Dave Evanson felt that there is a good history of LIMS being available and used. “Some labs have done a pretty good job of embracing that. But at the other end of the spectrum, there are some labs that still use a lot of paper. But many of these are starting to make changes. 

“There is also a lot of interest in going beyond just getting data, and learning more. And there is a push toward the producer of the data to get more information. New generation LIMS need to address this,” Evanson explained.

LIMS: Overwhelmed by Lab Data?

By Food Safety Tech Staff
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Thermo Fisher Scientific’s LIMS expert, Colin Thurston, explains how laboratory informatics can help food labs cope with large amounts of data as well as regulatory compliance.

The real challenge for food safety labs now is the amount of data that they are generating. “As analytical techniques have evolved, and instrumentation methods have become more sensitive, you can now process more and more information from a single sample. That kind of information becomes extremely difficult for a lab manager to process and to sift,” says Colin Thurston, Product Director, Informatics, for Thermo Fisher Scientific.

The big challenge for food processors is not the quality of the food but the brand. If something goes wrong with the food product, the consumer is going to remember it. So it is really critical for the lab to able to get the results to verify that the food is safe to eat, that too within a short time. 

What role does Laboratory Information Management System or LIMS play? “With the right LIMS solution, we can have the ability to automate, highlight the outliers, know which samples we have to go back and recheck, and which ones they have to reprocess because of challenges with the data. 

“Labs now are facing challenges around regulatory compliance. Regulations are changing and the food chain is becoming extended. Labs have to process a particular sample against many regulations as food companies want that product to be shipped to the U.S., consumed in Japan, Europe and so on. LIMS can store multiple sets of checks, carry out that process, and validate that product against all these requirements,” explains Thurston.

How can Food Safety Management Systems Improve Compliance and Reduce Risk?

By Food Safety Tech Staff
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LeAnn Chuboff, Senior Technical Director, SQFI, talks about using data within the food safety management system to prioritize and address food safety risks within the organization.

Food safety regulations are driving organizations to seek more methods of enhancing visibility into their quality and safety operations to increase compliance and reduce risk. As this need evolves, the tools inherent in the Food Safety Management System are crucial in helping an organization take a proactive approach to preventing food safety risks.  

LeAnn Chuboff, Senior Technical Director, SQFIWhat lessons can you learn by looking at and analyzing your non-conformance reports and how can you use these to better your food safety management programs?

LeAnn Chuboff, Senior Technical Director, SQFI, talked about using data within the food safety management system to prioritize food safety risks within your organization.

Speaking recently on the topic of How can Food Safety Management Systems Improve Compliance and Reduce Risk, Chuboff discussed the example of SQF analyzing a year’s worth of audit reports and non-conformances. Below are some excerpts. 

“We asked ourselves the following questions: What area has the greatest impact to food safety – is this impact overall, major, minor or critical? What is one of the main reasons for recalls? What is the top major or critical non-conformances? And what is the frequently missed element? And we identified allergen management as the top area.”

Chuboff listed the key requirements for an allergen management program:

  • The facility needs to have an allergen management program in place;
  • The program should have cleaning and validation requirements in place;
  • There should be a register of list of allergens maintained;
  • And the allergen management program should be thoroughly addressed in the facility’s food safety plan.

On further analysis, SQF found that 84 percent of the facilities were missing an allergen program; 13 percent of the non-conformances were due to improper storage of the food products; the next issue was that facilities have improper labeling in place – 2 percent of non-conformances were due to labeling issues. And another problem was inadequately addressing rework. 

So what can a supplier do in terms of corrective actions to address these non-conformances: 

  • Conduct validation study for SSOPs (validate it, test it, revalidate it) – if you don’t have in-house expertise, bring them in from outside; 
  • Identify ingredients as allergens at receiving, in process and rework – do a complete reassessment of the labeling program; 
  • Establish label inspection program at receipt and in packaging – work with raw material suppliers to ascertain that the labels are clearly specified, taking into account requirements of both the country that it’s produced in and the country it’s being shipped to; 
  • Include allergens in the facility’s HACCP plan; and  
  • Have a strong internal audit program – this will help you engage your employees, identify problems, and address them successfully. 

What can auditors and scheme owners do? 

  • Support additional research for effective allergen control;  
  • Training and guidance for auditors and suppliers is needed for this sensitive area; and 
  • Work on providing stronger GFSI guidance? 

In summary, Chuboff added that companies need to gather the right data, use the data available to identify areas of opportunity and establish KPIs; conduct a root cause analysis and use the tools available and work with all members on the team to develop a solution; avoid settling on simple solutions and immediate corrections and instead plan to get to the root; establish a preventive action plan for long-term control; and finally, repeat all the above! 

To listen to Leann Chuboff talk more on this topic, click here.

FSMA Sanitary Transport Rule: What You Need to Know

By Michael Biros
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Who does the proposed Sanitary Transport rule apply to and what will be its impact on the various transportation industries? This Q&A offers some insights and key takeaways from the critical rule.

On January 31, 2014, FDA announced the “Sanitary Transportation of Human and Animal Food” rule which will require certain shippers, receivers and carriers who transport food by motor or rail vehicles to take steps to prevent the contamination of human and animal food during transportation. The proposed rule establishes requirements for vehicle and transportation equipment, transportation operations, the exchange of information, training, written procedures and records. The proposed FSMA rule is broad and comprehensive and will likely have far-reaching effects across the food transportation industry.

In a recent FSMA Fridays webinar, sponsored by SafetyChain Software, Melanie Neumann and Jennifer McEntire, from The Acheson Group, answered some questions about the extent and implications of this rule.  We present some excerpts below. 

Who does the Sanitary Transport rule apply to?

Compared to other FSMA rules, the Sanitary Transport Rule’s coverage is broad and comprehensive. It will apply to businesses regulated not just by FDA, but by USDA as well. It will apply to food for human consumption as well as animal consumption. It will apply to both intrastate and interstate commerce. 

However there are a few exemptions: Companies with annual sales less than $500,000 and foods that are fully packaged and shelf stable are exempt. 

What impact will this proposed rule have on various transportation industries?

When it comes to Shippers and Carriers, this rule will affect everyone. Shippers need to establish and communicate with carriers about specific conditions for the food such as temperature control, cross-contamination control, hand-washing facilities for loading and unloading, etc. Carriers need to ensure that they are meeting the shipper’s requirements. They need to make sure equipment is appropriate and clean. Like other FSMA rules, this rule will require documentation. Carriers also need to complete a fair amount of training to establish how they can achieve these expectations. 

Receivers, historically, haven’t had a lot of responsibility in ensuring sanitary food transport. Now they have a regulatory obligation to do so. This rule will apply to anyone receiving food including retailers, food service, and small convenience stores. They will be required to actively participate and are subject to more regulatory oversight than they have had ever before. 

What is a waiver in the context of this rule and who might be eligible?

There are opportunities to receive a waiver and waive out of this rule. Those who qualify for a waiver are those who can prove that they are under other practices, protocols, and ordinances that ensure safe transportation of the food. For instance, businesses that transport USDA Grade-A dairy and pasteurized milk may qualify for a waiver. 

What are some key takeaways about the Sanitary Transportation Rule?

A lot of industry members have already implemented many of the best management practices that will be mandated by the proposed rule. Companies will need to focus on documentation and training. Companies will need to develop procedures to communicate requirements across shippers, carriers, and receivers. They will also need to develop training regimens and validation systems to ensure that these requirements are being met. Documentation is critical. In the eyes of a regulator, if it isn’t documented, it didn’t happen.

More information visit www.SafetyChain.com/FSMA-Fridays.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Is that Red Snapper on your Plate Really a Red Snapper?

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Over the past few years, several consumer and news organizations have researched and tested seafood available in supermarkets and restaurants. The findings:

  • Some 35 percent of seafood samples in the U.S. were found mislabeled; 
  • Of the fish that were most commonly mislabeled, 
  • Red Snapper topped the list (at 86 percent being mislabeled);  
  • Nearly 16 percent of grouper was mislabeled; 
  • In one out of five cases, Atlantic or farmed salmon was substituted for wild or King salmon; and
  • “White tuna” was mislabeled 100 percent of the time. 

A more recent investigation into fish labeling fraud carried out in Europe revealed that 32 percent of seafood in Italy, 30 percent of all hake in Spain and 19 percent of cod in Ireland were mislabeled. Repeated studies have shown that these results are not one-off, but seafood fraud is consistent and not showing signs of any improvement.

E. Pearce Smith, Laboratory manager, GeneScan, at Eurofins talks about the challenges in testing seafood authenticity. There are a couple of issues with regards to seafood fraud, Smith says: “From an economic standpoint, you could be buying a cheaper fish (for instance a breaded tilapia fillet instead of a breaded grouper fillet) for more money. Also, from a quality point of view, you lose out.”

More importantly, Smith adds, from a food safety perspective, if you are unknowingly processing a wild grouper sandwich, you are not considering the right safety, microbiological and decomposition markers for the wild fish. Or if it is a farmed tilapia product, you are not looking at prohibited veterinary drugs in farmed fish.

The horsemeat scandal that rocked large regions of Europe in 2013 was the basis for this focus, Smith says. “With horsemeat being sold as beef, producers were not testing their beef products for bute or phenylbutazone, an anti-inflammatory used by vets mainly to treat pain and fever in horses.”

When testing is an art as well as a science

So far, seafood species authentication depended on tests that were developed many years ago. FDA published a protein method known as isoelectric focusing, in which you take a piece of a tissue, digest it into a slurry and run it out into a gel. By comparing the banding pattern to known references, you can conclude what kind of fish it is. The problem with this technique, Smith says, is that it is often inconclusive, or at least open to interpretation in many cases.

So, about three years ago, FDA decided to abandon this 1950s technology for a more modern technology – DNA barcoding.  So now, instead of using a protein pattern, the test involves isolating the DNA and amplifying a specific section of it for analysis. 

“In a relatively short sequence, of about 700 base pairs, it’s very easy to distinguish one species of fish from another,” Smith says, adding that now food companies want to drive the switch from the protein testing to the DNA method.  Testing for the protein requires a lot more hands-on time and testing one sample can take several hours, Smith explains. “With the DNA method, you can automate the testing to a much higher degree to handle hundreds of sample a day. And with the cost of sequencing dropping, such testing is no longer cost-prohibitive,” he adds.

Robust methodology

The new methodology is robust because DNA is a very stable molecule, according to Smith. “You can test raw or cooked fish with this method, while the protein test was not as good at spanning the pre- to post-processed product. You can also test a finished product such as a frozen fish dinner.”

What are the limitations? Smith lists a few examples: Testing a food product that could have multiple types of fish, such as a fish cake or Surimi, which are ground up into a paste, and could have multiple seafood products in them. Canned tuna is not suitable for testing, because the high pressure process involved is very destructive and you may not be able to get a nice clean read of the DNA. FDA has identified about 150 unique species as targets for substitution, or of high commercial value at risk of being substituted for monetary gains.

“The samples that we get from food producers usually turn out to be what we expect them to be, but sometimes, they don’t. When we get samples from consumer groups, about 30 percent are mislabeled. Also, variations in regional names for that particular fish also contribute to confusion and mislabeling,” Smith explains.

FDA is now publishing the reference sequences for the different species of fish to make identification quicker and easier. Earlier people had to rely on private databases and some of these, while good, weren’t easily accessible. 

Smith sees a lot of demand for testing species such as salmon (differentiating pink salmon Oncorhynchus gorbuscha, Chinook salmon Oncorhynchus tshawytscha, or Coho salmon Oncorhynchus kisutch); and red snapper (which faces high demand but is low in supply, and is commonly substituted with other fish of the same size or color). He says that the importance for this testing is growing increasingly as companies are importing seafood product, and it is critical that the species be correctly identified on the packaging. Imports are the source of as much as 90 percent of the fish consumed in the U.S., and only about 2 percent of those products are inspected, he adds. 

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

How a Global Snack Powerhouse Follows Supply Chain Best Practices

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Mondelez-International-Brands-March2014
Known for its global brands such as Oreo, Ritz, Cadbury, Toblerone, Trident and Tang, Mondelēz International is a global snacks powerhouse, with products marketed in 165 countries. 

The company, which was created in October 2012 with spin-off of Kraft Foods Group, earned net revenues of $35 billion in 2012, and is the No. 1 in biscuits, chocolate, candy and powdered beverages; and No. 2 in gum and coffee. Mondelēz also employs approximately 110,000 people and works with nearly 3000 raw material suppliers. 

Against this background, the primary goal for the company is to provide Food that is Safe to Eat, described Peter Begg, Sr. Director, Global Quality Programs, Mondelēz International. 

Talking about Global Supply Chain Best practices at the recent Global Food Safety Conference, Begg described that his company ensures that its consumers and customers can trust the products that they manufacture and provide by: 

  1. “Having a comprehensive Food Safety program that meets or exceeds regulatory requirements and ensures global consistency; 
  2. Benchmarking annually to ensure the robustness of our food safety program including 3rd party audits (GFSI);  
  3. Continuously evolving our global strategies on Food Safety, with goals to drive further progress; and 
  4. Leveraging Supply Chain initiatives to support the Food Safety program.” 

At Mondelēz, food safety management occurs at multiple levels, said Begg: “The International Board of Directors Level reviews food safety management; the Executive Team level assesses company risk profile and management programs; food safety and quality senior management establishes food safety policy, control programs, and compliance mechanisms; business units implement company food safety policies and programs, and ensure regulatory compliance; and the Special Situations management team assesses and proactively manages issues, issues prevention, and communication of lessons learned.” 

Begg stressed that “companies need to make food safety culture personal, so people don’t bypass it. Mondelēz has had 0 incidents, 0 defects and 0 losses – and this will not be possible without 100 percent employee involvement.” 

He described an Integrated Quality Management Approach that focuses on systems across key factors in the supply chain: “Risk categories (covering chemical, microbiology and physical risks) are addressed along several steps (Design, Procure, Covert, Distribute, Trade and Consumer) using various quality risk prevention programs such as design safety analysis; HACCP; allergen management; supplier QA; material monitoring; continuous improvement; traceability, complaint management, process capability/ Six Sigma; warehouse controls and labeling.” 

Begg described Mondelēz’ quality and food safety programs that help assess, manage, and mitigate risk: 

Risk Assessment:

  • Supplier approval and management: determines suppliers risk profile and ability to meet MDLZ standards before use and on an ongoing basis;
  • Design Safety Analysis: new/changed product concepts are evaluated to design out potential physical hazards;
  • Hazard Analysis & Critical Control Points (HACCP) – focused on prevention, identifies conversion risks, controls, and monitoring compliance; and
  • Third Party Validation – validation of key systems; Design, HACCP, Micro, Allergen, Supplier, Auditing. 

Risk Management:

  • Auditing – risk based approach to assesses compliance to policy and execution of programs leading to corrective/ preventive actions;
  • Material Monitoring – incoming material testing program to verify the effectiveness of preventative programs;
  • Training – drives awareness of policies, programs, roles & responsibilities and enhances organizational competency;
  • Traceability – programs to manage and trace materials thru finished goods; 
  • Spec Management – specification development and change management process for materials, processes, and finished goods; and
  • Contingency Planning for single/ sole source and regionally isolated ingredients. 

Risk Mitigation:

  • Special Situations Management – defined company-wide process for proactive and effective management of issues minimizing potential impact to the business. 

Mondelēz has made a strong commitment to the Global Food Safety Initiative. According to Begg, the company has asked its nearly 3000 raw material suppliers globally to get certified under a GFSI benchmarked standard by 2015. All internal manufacturing facilities will have a GFSI certification (FSSC 22000) by the end of 2015 as well (currently 80 percent of facilities are certified). The company is also promoting GFSI to its external partners including joint ventures and external manufacturers.

Food Defense Rule – What You Need to Know

By Food Safety Tech Staff
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What is the Food Defense rule and how is it different from the Preventive Controls rule proposed under FSMA?

On December 24, 2013, the U.S. Food and Drug Administration proposed the Rule for Focused Mitigation Strategies to Protect Food against Intentional Adulteration under the Food Safety Modernization Act. 

Also known as the food defense rule, the proposed rule would require domestic and foreign facilities to address vulnerable processes in their operations to prevent acts on the food supply intended to cause large-scale public harm, and would require the largest food businesses to have a written food defense plan that addresses significant vulnerabilities in a food operation. Comments are due by end of the month.

In a recent FSMA Fridays webinar, sponsored by SafetyChain Software, Dr. David Acheson, and Melanie Neumann of The Acheson Group discussed this rule. We present some excerpts below). 

Who does the Food Defense rule apply to?

The goal of this rule is to put preventive controls in place where terrorism is a threat. By making this rule risk-based, FDA aims to prevent a single-point attack with potential mass casualties. This rule is focused on large manufacturers and processors of human food with sales of over $10 million. It will not affect small manufacturers or farmers with the exception of dairy operations and bulk liquids. 

If the rule applies to you, what do you need to do?

Assemble a food defense team with industry experts and come up with a food defense plan. Conduct vulnerability assessments. Think about the possible agents and the processes whereby that agent could be added to one of your foods. What are your actionable process steps and mitigation strategies? For instance, how can you control access to bulk liquids and bulk mixing? The food defense plan does not need to be validated, but it does call for training, monitoring, and documentation. 

What are the similarities and differences between Preventive Controls and Food Defense rules?

Unlike Preventive Controls rules, there is no need to validate that the Food Defense mitigation strategies are effective. Also, if you’re doing your own vulnerability assessment, you need to have someone who knows what they’re doing, but they don’t need to be a ‘qualified individual’ as required under the Preventive Controls rule. Another distinction is that with Food Defense, there’s no assumption that the food you produce is automatically adulterated if there are problems with your mitigation strategy.

How will I know if my Food Defense approach is effective?

It is impossible to know if a food defense strategy is effective without challenging the system. It is highly unlikely that FDA will simulate an attack to gauge Food Defense effectiveness. Even though the likelihood of a terrorist attack on the food supply is rare, the industry must go through due diligence to try to prevent attacks from happening. It is not enough to have a security camera in place if that camera doesn’t work or if no one is monitoring it. 

 

This rule will not be finalized until Spring of 2016. FDA wants comments from industry on Food Defense and on how it can be shaped into a practical and economically feasible program. 

Where does economically motivated adulteration fit into this?

FDA is covering economically motivated adulteration with the Preventative Controls rule, not Food Defense. There has been a lot of controversy regarding this decision. Where does precedent lead to a reasonably likely event to control? If the scope is not limited, this could require an excessive amount of testing for many different compounds in incoming ingredients with significant economic impact. 

More information visit www.SafetyChain.com/FSMA-Fridays.