Dr. Bob Strong

SQF Certification for Food Packaging Plants

By Dr. Bob Strong
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Dr. Bob Strong

The Global Food Safety Initiative is a set of standards created to assure confidence that food products meet international standards. GFSI sets the minimum requirements for Food Safety Management Systems, GMPs, GAPs, GDPs, and HACCP. All standards to get GFSI approval must meet the minimum requirements outlined in the GFSI guidance document. There are currently nine approved GFSI schemes, however only four apply to packaging.

Safe Quality Food or SQF, as it is more commonly referred to, originated as an Australian standard in 1994. It was purchased by The Food Marketing Institute in 2004 and is now operated by the Safe Quality Food Institute in the US. It was one of the first four GFSI approved schemes. It’s currently in edition 7.1 and is available from sqfi.com. Edition 7.2 will become effective July 3, 2014.

SQF offers three levels of certification: Level 1 is basically the fundamentals of food safety;  Level 2 requires at a minimum HACCP analysis and possibly a HACCP plan; and Level 3 requires a quality plan. GFSI approval only requires Level 2 SQF certification. 

SQF initial certification audits

The initial certification process requires two separate audits. The readiness audit reviews documents, programs, policies, and procedures to make sure that they match the SQF requirements. The auditor may look back through up to two years of records. SQF code also requires practicing continuous improvement and that the facility meets the regulatory requirements of the country in which the facilities operates as well as those of each country where product is sold. 

The second audit is a facility audit. This audit assesses how the facility is in compliance with the documented programs, policies, and procedures. The auditor will look at your equipment, building, processes, and records and will perform a graded evaluation. All deficiencies in this audit will need to be corrected before the Certifying Body can issue a SQF Certificate. For packaging plants, this audit usually takes two days but can take longer. Recertification only requires one annual audit that is a combination of the readiness audit and facility audit.

SQF practitioner

SQF certification requires that facilities employ a full-time SQF practitioner that is in a position to manage the program. This person must have completed an accredited HACCP course and be competent to implement and manage HACCP plans. They must also have SQF code knowledge and be competent to implement and manage SQF programs. While not required for certification, taking an SQF implementation course is highly recommended.

SQF for food packaging manufacturers

SQF has products and services divided into 35 food safety categories of which Category 27 is “Manufacture of Food Sector Packaging Materials.” The two modules of SQF code that require compliance from packing manufacturers are Module 2, SQF System Elements and Module 13, Pre-requisite Programs for the Manufacturing of Food Sector Packaging. The other modules do not relate to packaging and will not be part of the audit of a packaging facility.

The following are SQF mandatory sub-elements that are required to be documented and implemented by everybody. They cannot be excluded, exempted, or marked as non-applicable by the auditor. There are only mandatory elements in Module 2; there are no mandatory elements in Module 13.

  • 2.1.1 – Management Policy
  • 2.1.2 – Management Responsibility
  • 2.1.3 – Food Safety and Quality Management System
  • 2.1.4 – Management Review
  • 2.2.1 – Document Control
  • 2.2.2 – Records
  • 2.4.1 – Food Legislation
  • 2.4.2 – Food Safety Fundamentals
  • 2.4.3 – Food Safety Plan (levels 2, 3)
  • 2.4.4 – Food Quality Plan (level 3 only)
  • 2.4.8 – Product Release
  • 2.5.2 – Validation and Effectiveness
  • 2.5.4 – Verification and Monitoring
  • 2.5.5 – Corrective and Preventative Action
  • 2.5.7 – Internal Audit
  • 2.6.1 – Product Identification
  • 2.6.2 – Product Trace
  • 2.6.3 – Product Withdrawal and Recall
  • 2.7.1 – Food Defense
  • 2.9.2 – Training Program 

Nonconformities

A minor nonconformity must be corrected within 30 days of the facility audit. Extensions may be granted by the certification body where there is no immediate threat to product safety and quality, and alternative, temporary methods of control are initiated. 

A major nonconformity must be corrected and appropriate corrective action verified and closed out within 14 days of the facility audit. 

A critical nonconformity raised at a certification audit results in an automatic failure of the audit and the supplier must reapply for certification. 

Nonconformities can occur during the document audit or during the facility audit, but only the facility audit is scored. Out of a possible 100 points, a critical nonconformity will deduct 50 points, a major nonconformity will deduct 10 points, and a minor nonconformity will deduct 1 point each. All nonconformities should be corrected before an SQF Certificate will be issued, however if all minor nonconformities have not been corrected, a certificate can still be issued within 45 days of last day of facility audit. A score of 96 to 100 is ‘excellent’ (E), 86 to 95 is ‘good’ (G), 70 to 85 is ‘complies’ (C), and 0 to 69 is ‘fail’ (F). A certificate will be issued for grades of excellent, good, and complies. Excellent and good grades require a 12-month recertification audit and a grade of complies requires a six-month recertification audit.

The above article has been adapted from an archived webinar, hosted by SAI Global and presented by Dr. Bob Strong. For more details, please click here. 

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

The Value of Effective LIMS

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

With the announcement of proposed rules under the Food Safety Modernization Act (or FSMA), the burden of food safety testing and record keeping placed on smaller and medium size food companies and use of contract testing labs is growing tremendously. So how do these labs manage growing requests for testing, and increasing volumes of data and demand for records? 

Here is where Laboratory Information Management Systems or LIMS play an important role, in helping labs manage the testing requests, handle all the data and records, be better prepared for audits, and comply with changing regulations, says Anthony Uzzo, President & Co-Founder of Core Informatics.

Uzzo has extensive experience in software engineering, informatics, laboratory automation, project management and science. He co-founded Core Informatics in 2006, along with Jim Gregory (Executive VP of Customer Solutions). A biomedical engineer, Uzzo started his career as a pharmaceutical lab scientist, and in that role, realized that most LIMS solutions were rigid in their scope. 

“This exposed me to different labs having different data management requirements, and gave me a profound appreciation of the impact of data management and having effective LIMS in labs. When starting Core Informatics, my goal was to provide labs with the opportunity to tailor their data management system to their needs without having to change their workflow, systems, personnel etc.,” he describes. 

We present below some excerpts from an interview with Food Safety Tech (FST).

FST: Why are LIMS so important for food and beverage companies in the current environment?

Uzzo:The food and beverage industry faces increasing regulatory scrutiny, pressures to control costs, and the challenge of maintaining quality throughout a global supply chain. A LIMS solution needs to be a solution to aid companies in the delivery and discovery of products, while complying with industry and government regulations.

The LIMS need to identify hazards, determine and monitor critical control points, and establish corrective actions and verification procedures to ensure that standards are met and the system is functioning properly. Our HACCP compliant system helps companies in the F&B industry to monitor products and make sure they do not become contaminated with chemicals or food pathogens. 

FST: How can food companies and labs choose the ideal LIMS solution?

Uzzo: According to me, the top criteria for choosing a LIMS solution would be flexibility; being web-based (able to use the LIMS with smart devices for data entry and access and no antiquated client server technology); and total cost of ownership.

There are now all sorts of novel testing methodologies being applied for food safety, and as a result, the data management requirements are constantly changing. Solutions would need to facilitate administrators to use the LIMS without writing a new code, and easily and quickly enable multi-site collaboration. For instance, there are new rapid detection technologies, such as PCR technologies for Salmonella detection, now in the market. An ideal LIMS should be able to rapidly process these results and use that data analysis, come up with efficient reports and enable lab scientists to do their job in a cost-effective manner. 

Cloud-based solutions offer great advantages in providing the ability to auto-scale, handle any amount of data, send out samples to other labs, support multi-site collaboration etc. Core Informatics, for instance, is fully embracing the power of the cloud. 

An ideal LIMS solution should address chain of custody from registration to report. The final report needs to be mentioned and be able to track who had handled that sample and every derivative of it, how it has been handled, under which condition it has been stored and for how long, and if appropriate procedures have been followed for storage and handling. Downstream, if there’s any problem, we need to be able to go back upstream and identify the correct source material.

LIMS solutions need to be prepared as new laws come into play in the next few years. Industry trends are accelerating the use of contract food testing labs. How effectively companies are able to process their data management requirements such as automatically receiving and recording test requests, preparing for their audits and complying with their food safety management programs, will all become critical.

What Constitutes a Successful FDA Audit?

By Sangita Viswanathan
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From the proposed third party accreditation rule, to GFSI audits, and needing more trained and experienced auditors, the process of auditing food facilities is undergoing a sea-change. What is the impact going to be on food companies, auditors, and the auditing process?

In a recent FSMA Fridays webinar, sponsored by SafetyChain Software, an expert team from The Acheson Group, comprised of Melanie Neumann, J.D., M.S., VP and Chief Financial Officer; Jennifer McEntire, Ph.D., VP and Chief Scientific Officer; Anne Sherod, M.S., Director of Food Safety and Valerie Scheidt, MBA, CP-FS, Director of Food Safety, answered key questions on conducting successful FDA audits. We present some excerpts below.  

How does the FSMA third party audit accreditation rule impact the audit process?

 

The purpose of the third party accreditation and certification audit is to issue a certificate for high risk foods or the voluntary qualified importer program. The main foundation of the standards that FDA is setting will come from the human preventative controls rule, the animal preventative controls rule, and the produce safety rule. Some standards may also come from the sanitary transportation rule and food defense rule. FDA will be appointing an accreditation body and this accreditation body will approve and monitor certifying bodies (CB). These CBs can be private companies or private individuals who will be authorized by the accreditation body to perform the audits and issue those certifications. 

 
Foreign governments can also be approved by FDA to act as a CB. Right now only New Zealand is approved and FDA is looking at approving Canada. We don’t anticipate any other country to be approved in the near future.;

Certifying bodies will have strict conflict of interest and reporting requirements to FDA. CBs must report to FDA within 45 days even if they’re just performing a consultative audit. They must also report to FDA if they see an issue that could lead to a Class I or Class II recall and they have to report to FDA before they report to the company that they are auditing.

 

Will a GFSI audit satisfy FSMA audit requirements?

GFSI audit requirements do not match the FSMA audit requirements, but they are not too different. Several of the schemes are very similar, and each scheme owner is making a concerted effort to become FSMA compliant. If an auditor is doing a GFSI audit, they do not need report to FDA before the company. The FSMA requirements of avoiding conflicts of interest, record keeping, and training may deter GFSI auditors from becoming Certifying bodies under FSMA. Unless FDA offers an incentive, there will be a shortage of FSMA CB auditors. 

 

What are the elements of a successful audit?

The number one goal of an audit is to identify risk. The audit needs to accurately describe the non-conformances against the audit standard to give your quality and operations team reliable and actionable data so they can mitigate that risk. The relationship between the auditor and the facility should be a partnership, add value, and build trust. The facility should learn from the auditor and the auditor should understand what the facility is doing to mitigate risk and promote food safety. Continuous improvement takes the feedback from the non-conformances and evaluates them against the organization’s goal around risk. Whether the results are from an announced, unannounced, internal, second, or third-party audit, continuous improvement is critical, and this requires commitment from management and will help the facility become audit ready. 

 

How can I ensure my auditor is up to the task?

Most audits use checklists. This goes for both the auditor and the audited. The checklist provides a standardized list of what’s expected and adds an element of order and control to the audit. It also allows for an effective way to quantify metrics. 

However, using a checklist alone can lead to minimum risk finding. The auditor needs to find a balance between being strategic and prescriptive. In order to be effective, audit protocols need to be periodically reviewed and updated. This is especially relevant with FSMA and holds true for internal and third-party audits. Check to see if the auditor’s checklist is pre-FSMA or post-FSMA. Ask the auditor when was the last time that they reviewed and updated their audit protocols. 

 

Will we have enough good auditors to meet the need?

No, we already don’t have enough good auditors. The implications of this are that we may get substandard audits from substandard auditors. The current model isn’t working and we need a new approach. Currently, most auditors have extensive prior experience working in industry and often become auditors after they retire.

We are creating auditors not through structured training. This model is not sustainable and has limited growth potential. It will not provide the level of training required for GFSI or FDA third party certification requirement. We need a training program for auditors who come right out of school. We need people to go to school for food safety and be able to become an auditor after graduation. Food safety needs to be incentivized at the university level. There should be a bachelors degree in food safety auditing. We need structured training and developmental opportunities for folks earlier in their career rather creating auditors at the end of their career.

Training in the Food Safety Industry

By Sangita Viswanathan
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Dr. John Surak food safety trainer and Warren Hojnaki of SGS talk about trends they see in food safety training, areas of focus, how to keep training relevant and useful, and what they are expecting to see in the future.

FDA, FSMA, FSMS, HACCP, GFSI, BRC, SQF, IFS, FSSC… The food safety sector is a cornucopia of new regulations, abbreviations and standards. Helping navigate this maze are food safety training courses and the instructors. However, the success of training programs depends on how applicable these courses and the curriculum are to the industry and the specific client, and how experienced and knowledgeable the instructor is in understanding current regulations, specifications of standards, hazard profiles and compliance requirements of that client. 

In an interview with FoodSafetyTech.com, Dr. John Surak, food safety trainer, and Warren Hojnaki of SGS, talk about trends they see in food safety training, areas of focus, how to keep training relevant and useful, and what they are expecting to see in the future.

John Surak, Ph.D., is principal of Surak and Associates, a full service food safety and quality consulting service. He works with the food processing industry in developing food safety and quality management systems, designing and implementing process control systems, and implementing Six Sigma and business analytics systems. Warren Hojnacki is Training Manager, for SGS North America. His department delivers training services for North American clients. 

FoodSafetyTech.com: What are some broad trends in food safety training that you are noticing?
Hojnacki: What we are seeing is a lot of clients needing foundational training. For instance, our most popular training programs are still HACCP, implementation for FSSC 22000, SQF etc. On the other side, clients are still very confused about what they should do regarding new and proposed food safety regulations. While they are following the directives that they receive from their customers, currently there still is a wait-and-see mentality. 

Dr. Surak: I notice the focus on food safety moving up the food chain. About 5 to 7 years ago, our primary clients for food safety training programs were food processing companies. Now our clients are suppliers to these companies as food companies are pushing the requirement for training on them. These supplier companies then need to make decisions on what schemes they want to be certified under. Most of the time, the customer accepts any GFSI-recognized scheme, but sometimes the customer names a specific scheme. Different GFSI schemes have different sweet spots and advantages. They all assume different knowledge about food safety and some are more prescriptive than the others. Clients have to figure out which scheme would be the best fit for them. 

FST: What kind of training courses are most popular, most asked for?
Hojnacki: When clients and companies decide on getting audited or certified against a particular food safety standard, training for that standard is a common requirement. Auditors specifically want to be trained to build their skill level, whether it’s getting trained for HACCP or FSSC 22000. A number of our clients also come to us saying that when they have a 3rd party audit, the most common non-conformances pertain to a less than robust internal audit system, so auditor training is a critical area that our clients ask for. 

Dr Surak: One of the biggest aspects of training that I try to focus on is lead auditor training. This course is designed to help an individual get certified in a particular audit scheme. We cover the same information for internal auditor training. However, the difference in this case is that for the internal auditor, the goal is to get his company certified. If a company has a strong internal auditor, they can reap substantial benefits. We also focus on, as part of our training, doing mock audits. This is more than going into a course or workshop and giving a lecture. For mock audits, you are put into a spot where you have to make real decisions on the floor. When we conduct such practice audits with our clients, in addition to our regular food safety training courses, we find a high level of involvement and interaction from the attendees and appreciation from the client. 

FST: What are some of the gaps in the training that you notice?
Hojnacki: What we see in general is people not covering the topic in-depth enough. Many training courses (outside those offered by SGS) seem to cover the topic in a very superficial manner and this doesn’t help. 

Dr. Surak: Many of the attendees who come to an audit training class have never taken the time to familiarize themselves with the standard. So what you are doing in that time is teaching them the standard and then teaching them how to audit. If the participants already know the standard, then you focus on just reviewing the standard and cover how to go about doing the audit. 

FST: What are some common questions attendees ask at ‘implementation/auditor’ training?
Hojnacki: Attendees very much want to know application to their respective situation. As an auditor, you need to know the right open-ended questions to ask when you are conducting an internal audit, and in our training, we provide examples for that. 

Dr. Surak: Our training focuses on enabling auditors to get the participant in a conversation and be able to answer questions during an audit. We are not in the business of writing traffic tickets, we are out to assess if the food safety system meets the standard, and also to identify the areas where it needs to be strengthened. Things that participants typically want to know are, going into a 3rd party audit, what is the auditor going to do? How is he going to react? And how can they present themselves in the best possible way to have a good audit? Also the instructor or auditor needs to understand the differences in the standards and the different hazards. There are unique challenges for different suppliers – or where along the supply chain they are, for instance are they a retailer, a supplier or a processor. It’s not a one size fits all situation. If you are looking at ingredient suppliers, the hazards are very different than what a retailer would be looking at, for instance. 

FST: How do you identify the best training company or program for you?
Hojnacki: We go through this everyday with every client call and we understand that we are not the only resource, our clients have several options. We first evaluate the trainer to understand what’s their educational and work experience background? Does it correlate to the industry you are in? Are they practitioners or just theorists? Food industry is a very big growth area right now, and we are seeing a proliferation of tutors coming into this field. Some of them have varied backgrounds, such as in automobile or aerospace industry. Often times, clients will make a decision based on prices quoted, and then realize that it didn’t work out the way they had anticipated. We (SGS) have often had to go to that client and redo things. Today, more than ever, the decision to choose a trainer/ training vendor, needs to be based on their competence, experience, and skills. 

Dr. Surak: I was recently at a client where they had completed certification training. When I asked to see the materials and bios of the instructor, I noticed that he had no prior experience in the food industry. I wondered how you could teach internal auditing in a food processing industry if you did not know about food processing! It’s imperative that clients look at the trainer’s background and experience. 

FST: Food safety training in 2015 – what will change?
Hojnacki: Food safety training curriculum will have to increasingly show greater applicability to clients to meet their needs. It has to be a round peg and in a round hole type of situation. Especially with FSMA rules getting finalized, clients are going to expect more out of their training. They are going to expect their instructors to be a resource, and to be up to date on the respective regulations and be able to tell clients how these rules will apply to them, and what they need to do differently. 

Dr. Surak: Processors are going to ask questions such as ‘I am certified to a GFSI scheme, so now do I have to do anything additional to meet new requirements’ or ‘are there areas where we have done some basic groundwork, and we have to raise the bar higher because of new regulations,’ and trainers need to be able to answer these.

Social Media and Food Safety: What Clicks and What Crashes

By Food Safety Tech Staff
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Food safety concerns are everywhere. Social Media is everywhere. When the two get together, it can mean both good news and bad news for industry players. Some tools for success: Learn to manage risks in this environment; accept that transparency is not an option; translate PhD to ADD; and communicate creatively.

Social media can be a great tool to connect with consumers, and influencers, and promote your brands and systems and procedures used to further food safety and quality. But on the other hand, it can also create an avalanche of food safety concerns and negative publicity that can very quickly spin out of control. How can food companies effectively manage social media channels, and use it to their advantage, and how can they respond to crisis in this world? Four industry players shared their perspectives during a session at the recent Food Safety Summit, held in Baltimore. 

Managing risks in current environment

Daniel Webber, Senior Vice President and Group Head at Edelman, digital corporate and crisis group, painted a scenario by wondering what would have been different if the Jack-in-the-Box incident would have happened today: “An employee could have suggested that the meat had not been cooked long enough, or to a high enough temperature. There would have been comments flying back and forth in FaceBook and Twitter, and soon there could have been mass hysteria about the burgers,” he suggested. 

Food companies have to deal with three types of risk in the current environment, explained Webber: Unanticipated or unpredictable risk, which leads to the company being blindsided; episodic risks which are like waves in the food business – incidents than come and go; and endemic or systemic risk – which is those ‘we should have seen coming,’ caused by a lingering product issue, what he described as a ‘Lance Armstrong’ curve. 

To be better prepared, Webber listed the following steps:

  1. Monitor all media to building intelligence (“monitoring is free research”); 
  2. Develop a plan; 
  3. Do scenario planning (if one of your companies is going through such an issue, what would you do); 
  4. Train (to build muscle memory); 
  5. Make friends now (make them speak for you when needed); 
  6. Tell your story; and 
  7. Get others to tell your story. 

But, he warned, “if it’s truly a crisis, you will need lawyers, publicists, and experts who can help you address that, so know when you need a bigger boat.”

Transparency is not an option, but a necessity

Tara Clark, Consumer Affairs Manager – Social Media, at ConAgra Foods, Inc. manages social media perceptions of the company’s brands, several of which have 100,000 + followers. 

Clark listed some of her observations on what triggers social outrage. Personal experiences: if a friend of family member gets affected or sick that is a huge factor, she said. And how the responds to the situation matters. 

“Consumers take the opportunity to challenge you, and ask you to prove it to them that you deserve their loyalty.” She referred to Google University (and Snopes, Wikipedia etc.) that become trusted sources of information, and active bloggers and consumers who become influencers for the market. 

Clark described the situation of Orville Redenbancher popcorn recall: “We thought it would be a big issue on social media and were worried about posting information about it, but instead of getting negative comments and people ganging up against us, people were supporting us, appreciating our honesty and transparency.” 

Her advice to food companies?

  1. Consumers are your brands’ friends & family, so treat them so; 
  2. Have a personal conversation with them; 
  3. Engage, but don’t force education; 
  4. Know who’s influencing your communities; 
  5. Trust your gut and instincts; 
  6. It’s okay to be human in social media; and 
  7. Remember that transparency is not an option; it’s a necessity. 

Translate PhD to ADD

Charlie Arnot, CEO of the Center for Food Integrity, talked about what drives consumer trust. The larger you are as a company, the more you have to prove that you are trustworthy, he described. 

Arnot talked about a study conducted by the Center which looked at two different scenarios and how consumers reacted to companies’ responses to a fictional food outbreak. The leading factor that garnered a good response was a company’s willingness to accept responsibility in a timely manner. “How and when you engage makes all the difference in recovering from social outrage,” he added. 

Summing up, Arnot listed the following takeaways:

  1. Social decision-making process is complex and multidimensional; decisions are not made on facts and rational thought alone; 
  2. Mistrust of institutions has become the social norm and people are questioning the data and motives of experts; 
  3. Tribal communications, relationships, and experiences influence what you believe; 
  4. Communicating shared values makes science more relevant and gives the public permission to believe your information. 
  5. And finally, the public wants information from academics, but not academic information. So you need to translate PhD to ADD. 

When CDC trended above Christmas

Dana Pitts, Associate Director for Communications in CDC’s Division of Foodborne, Waterborne, and Environmental Diseases, started by saying “Information is CDC’s main product. Getting that data to you is enabled by the interaction between scientists and communicators at CDC and social media plays a big role in these communications.” 

“My job is to tame the science that comes out of the various centers within CDC. And communicate it via our 57 twitter profiles, 18 FaceBook profiles, 14 blogs, two LinkedIn profiles, YouTube, Google +; Flickr; Instagram; several mobile and tablet apps, web and text messaging…” she explained. 

Pitts talked about the Centers recently communicating 40 years of Salmonella data in a manner that people can easily find it and understand it. 

She described a successful social media campaign that CDC ran through the holiday break of 2013, in which experts from the CDC, U.S. Department of Agriculture, U.S. Food and Drug Administration, and the International Food Information Council Foundation answered Twitter users’ questions on food safety during the holidays. 

“The conversation, “Don’t toss your cookies’ was a great success. In one hour, there were 731 participants. We had 40 partners, 718 tweets during chat, with a potential reach of 58 million. At one point, we were trending on Twitter, just above Christmas,” Pitts proudly described.

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.