Marijuana Edibles: A Regulatory Nightmare

By Aaron G. Biros
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With an estimated 8 million to 12 million servings of edible marijuana already sold in Colorado, there is cause for concern over food safety testing, and how manufacturers will tackle challenges like regulatory compliance and quality assurance.

When Colorado made history this year by legalizing recreational marijuana use, lawmakers were tasked with creating a regulatory framework for the production, sale, and use of the previously illegal substance. While Colorado has addressed issues such as taxation and cultivation of the plant, the state has struggled to provide clear guidelines for food safety, testing, and lab certification regarding marijuana edibles, causing difficulties for regulators and manufacturers alike.

Federally, USDA and FDA are reluctant to regulate the nascent industry because marijuana is still considered a Schedule I narcotic by the DEA. The Colorado Department of Public Health and Environment is unwilling to regulate marijuana edibles out of fear of jeopardizing their federal funding.

In lieu of the Department of Public Health and Environment’s oversight, the state allows the Marijuana Enforcement Division, under the Department of Revenue, to handle food safety and lab certification. It appears this regulatory agency may be in over its head as concerns grow over potency testing and labeling in the wake of two deaths allegedly involving the overconsumption of marijuana edibles. Adding insult to injury, the Denver Department of Environmental Health cited 58 violations at 24 edible marijuana establishments this past month.

Still, with an estimated 8 million to 12 million servings of edible marijuana already sold in Colorado, there is an immediate cause for concern in food safety testing. As the edible marijuana industry grows, so do worries over how manufacturers will tackle challenges like regulatory compliance and quality assurance.

Ben Pascal, Co-Founder and Chief Business Officer of Invisible Sentinel, feels that there is a lot more the government should be doing right now. “This is a growing trend that will continue in the United States; these products will continue to gain market share and there should be some sort of guidance on how and when to regulate the safety of these products,” explains Pascal.

Invisible-Sentinel-June-2014
Invisible Sentinel’s rapid molecular diagnostics product, Veriflow, can help address some the concerns around risk in conducting testing for marijuana edibles,” says Ben Pascal.

With a rapidly growing industry, more producers of pot edibles are finding it harder to meet regulatory compliance goals. “Larger accredited labs in the US find that there is risk in conducting testing for marijuana edibles,” says Pascal. He believes that Invisible Sentinel’s rapid molecular diagnostics product,Veriflow, can help solve some of these issues.

“We make molecular testing more accessible with low cost, ease of use, robust technology, and the ability to bring all of this testing in-house, helping to eliminate risk factors for clients,” describes Pascal. While Veriflow has the capability to alleviate some quality assurance worries, Pascal points to the lack of regulatory oversight as the main issue.

“If you are not going to be regulated by the federal government, holding you to a safety standard, then smaller groups will not make the proper investments to ensure the safety of their product,” Pascal explains. “It is not about cost, it is about the lack of education and knowledge surrounding the implications of food safety issues in this industry.”

After some of these smaller regulatory hurdles are cleared within the state, then we can start to look toward future food safety standards in the marijuana edibles industry on a national level. Colorado’s experiment in legalization foreshadows some of the issues we will face when marijuana is accepted at a federal level.

As this trend continues, we should act preemptively to alleviate regulatory headaches before they are exacerbated, Pascal adds. The nation’s agencies need to be ready to embrace the legalization of marijuana and related food products in order to prevent real safety issues from surfacing.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Food Safety Training: Trends and Gaps

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

With new regulations demanding more testing, consumer preferences and cost pressures creating global supply chains and markets demanding faster distribution, what are some of the demands on the food safety testing market? In this Q&A, 3M Food Safety Division’s Technical Service Director Nancy H. Eggink talks about trends and concerns when it comes to food safety testing and training. 

Food Safety Tech (FST): What are some big shifts/ trends in food safety testing that you are noticing?

Nancy Eggink: Not necessarily big shifts, but customers still are looking for easy to use tests that provide fast accurate results, The target lists are broadening (microorganisms & allergens), and the sample matrices more and more complex. Following R&D trends, nutraceuticals, unique flavors and novel processing are changing the foods, environments, and ultimately the testing needs. Currently available, and future tests must be able to accommodate these sample matrices and the innovations as they are commercialized.

FST: Given the evolving food safety regulations, how are educational and training needs for food labs managers and testing changing?

Eggink: When considering GFSI schemes and FSMA, the requirements indicate competencies and what constitutes a ‘qualified individual’. So now, it’s not just a requirement to have a training program and adhere to what the training program includes. It is a requirement to lay out competencies that an individual must have after training. This indicates the training should be developed to ensure it’s effective in delivering the appropriate content in a way the learner will develop a competency, and also it should be verified through an assessment process to ensure the competency was developed.

FST: What are some of the gaps in food safety testing that need to be addressed?

Eggink: Food industry leaders are looking for ways to ensure that they have fast accurate information to make the best possible decision at each step in the process. Without compromising accuracy and reliability, opportunities are those that make testing easier to use, provide faster results and improve productivity.

FST: What are areas of training that clients are seeking out the most? And why?

Eggink: With all the guidance and requirements available, it’s easy to get consumed with keeping up on the changes happening constantly. Our customers are looking to 3M Food Safety for training on how to effectively use our solutions so to ensure they have fast accurate information to make the best possible decisions. Our customers are seeking effective and efficient ways of staying current in their professional life that fits into their work demands, and we have a key initiative to provide them with access to high quality educational content and scientific information. This educational content will be offered in the form of hands-on product training, live seminars, on-line self-study and webinars to help them with their current and potential future challenges.

FST: What impact will lab accreditation have on food safety testing and methodology?

Eggink: Lab accreditation is similar to the GFSI schemes and FSMA in the sense it is development and implementation of a quality system within the laboratory operation to ensure predictable outcomes. Specifically, minimize the variation between the technology, processes, samples, technicians, tools, environment and ensure safety. Standardization of training & education is a critical component within that quality system to ensure consistency within that system.

FST: Specifically about 3M Food safety – what are your focus areas in terms of new products, testing solutions?

Eggink: Global regulations are changing and Microbiology labs are faced with considerable challenges including but not limited to rapid results, increasing volume of work, cost constraints and increasing customer, media and regulatory scrutiny. Our focus is to provide solutions in the food diagnostics testing market to address these needs at all levels and penetrate local markets and geographies. Pathogens are a real threat to public health, and we have recently launched an additional assay to our Molecular Detection System (Listeria monocytogenes), while working to ensure all assays have third party certifications against reference methods such as AOAC and AFNOR.

We also continue to innovate with Petrifilm™ Plates. Petrifilm™ Salmonella Express System provides a qualitative confirmed Salmonella result in as little as 44 hours which is two times faster than agar methods. The newest solution is Petrifilm™ Rapid Yeast and Mold Plate that provides quantitative Yeast and Mold counts at 48 hours. As customers ask for easy to use, faster results that don’t compromise accuracy and reliability, we will continue to innovate to meet those needs.

Barbara Levin, SVP of Marketing & Customer Community, SafetyChain Software

What is True Food Safety Audit Readiness… and How Can Automation Help?

By Sangita Viswanathan
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Barbara Levin, SVP of Marketing & Customer Community, SafetyChain Software

Barbara Levin, Senior Vice President and Co-Founder of SafetyChain Software, shared her thoughts during a recent interview with Food Safety Tech. 

Food Safety Tech (FST): Why are food safety audits such a hot topic of conversation?

Barbara Levin: Audits are a critical component of any food safety plan, and I’ve never heard food safety and quality assurance (FSQA) folks disagree with that assumption. But between regulatory, 3rd party standards such as GFSI, customer and internal audits – most of which are still very manual processes – audit preparation and response have become a huge manual burden that can be highly disruptive to operations. And while all audits has some commonalities, each has its own specific requirements as well, adding to the challenge. 

In conversations with our clients at SafetyChain, we have heard of companies that have as many as 300 audits a year! So it’s a struggle to manage these audits while also having to get product out on time, within operational Key Performance Indicators, and of course meeting safety and quality requirements. This is why we’re also hearing more about technology solutions that can help companies be audit ready. But whether or not a particular solution is right for your company depends on how you define audit readiness. 

FST: Before we discuss the definition of audit readiness, you mentioned that each type of audit has its own requirements – can you highlight some of these?

Levin: Let’s begin with what all of the audit types have in common – which fall in to four areas: 

  • First, you have to say what you do – all of your SOPs, PRPs, GMPs, HACCP/HARPC components, etc. 
  • Second, you have to verify that you do what you say. 
  • Third, you have to validate that it works. 
  • And last, you have to ensure that everything is documented. 

On top of these commonalities, each audit type has some specific requirements. For example:  

With regulatory audits, USDA can ask for pre-shipment reviews, while FDA can do unannounced audits with just a two hour notice.  

  • With the GFSI schemes, you have to have an approved vendor program and be able to demonstrate management commitment and continuous improvement. And of course everyone is talking about the upcoming SQF unannounced audits, which, I personally think, is something that the industry should embrace.
  • With customer audits, it’s not just about safety, but also quality attributes such as weight, moisture or salt content to name just a few.
  • And internal audits can be the hardest of all as many of the above elements, among others, can get combined. 

FST: Given this wide range of requirements, what then, do you mean, when you say “true audit readiness?”

Levin: When you hear people talk about audit readiness, and audit automation solutions, the conversation is often focused on documentation – the ability to produce electronic records. And this is of course an important component of being audit ready. But in my view, true audit readiness goes far beyond documentation. It should also mean that you have the tools and processes in place to ensure that you actually PASS your audits with flying colors! It means that food safety systems have been consistently and diligently followed across all facilities; you have a robust supplier compliance program; non-conformances are caught at the earliest point possible, and CAPAs have been put in place; you have easy access to data for continuous improvement; and everything is documented. In other words, it’s not enough to just show that the paper has been gathered for the audit – but that you are doing the right things for food safety every single day. And if we’re talking about audit automation technology – these solutions should support all of these components.

FST: How can companies assess if they’re truly audit ready?

Levin: Here are some basic questions FSQA teams should ask themselves:  

  • Are we 100 percent sure that all SOPs, CCPs, PRPs, GMPs, etc., are current and being carried out, and that we can easily access verifying documentation?
  • Do we have a robust supplier compliance program to ensure vendors are meeting our safety and quality requirements? Can we easily access all of those records?
  • Are we getting non-conformance alerts in a timely manner to take corrective/preventive actions before product goes in to commerce? Can we easily access proof of CAPAs?
  • Do we have easy access to all of the data required for trending, hazard analysis and continuous improvement? 

There can be three answers to these questions: Yes, No and Hmmmmm. If you’ve had one or more No’s or Hmmms… chances are you may not be as audit ready as possible. 

FST: What are then the challenges to being truly audit-ready?

Levin: I would list the biggest challenges with being audit ready as falling into four key areas:

  1. The volume of forms, records and paper that needs to be current, managed, easily accessed and actionable – meaning the data from these records can be trended for continuous improvement;
  2. Ensuring that all food safety programs are being carried out correctly and consistently – including the ability to catch problems at the earliest point possible, put a corrective/preventive action in place and make sure that all of that is documented;
  3. Management of supplier compliance (are you sure your suppliers are following all of your requirements?) and approved vendor program management; and
  4. The amount of time it takes to prepare for audits – especially as unannounced audits become more prevalent. 

FST: How can automation help with these challenges?

Levin: Technology solution that helps companies be audit ready must go beyond document management. They have to integrate supplier/vendor management; food safety and quality program management – HACCP and HARPC programs, for example; process management and workflow; GFSI program compliance; and, of course, ensure that all records and documentation is available in a central repository for trending, continuous improvement and of course audit readiness.

These solutions should automate, streamline and improve FSQA. And the final result has to be that actionable data – across all products and facilities – that allows you to find ways to improve processes, put preventive controls in place and make continuous improvement an inherent part of company’s overall food safety culture. Audit readiness then becomes the benefit – not just the goal. 

If you are using a cloud based FSQA automation solution – with roles-based security – automation can provide the kind of transparency and visibility that can actually reduce the amount of audits a company has by allowing suppliers, auditors and customers to view various slices of data. For example auditors might see non-conformances and the documented CAPA; a customer could see a finished product review; and a supplier can see that their Certificate of Analysis was received and met specifications. That’s a true change in traditional culture, but we’re seeing it more and more. 

Food companies need to remember that auditors do not expect to see that everything thing was perfect all the time. But what they do want to see is that a problem was found in a timely manner and that it was fixed before the product went into commerce. Bottom line? Automation can help food and beverage companies say what they do, do what they say, make sure it works and make sure it’s documented and actionable. And when all of this information is easily organized by the type of audit – and cloud-based – companies can be audit-ready on-demand! 

Click here to read Barbara Levin’s paper on how to be audit ready, on-demand with Food Safety Chain Management Systems.

Ask the Compliance Expert: Unannounced Audits

By Sangita Viswanathan
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Do you know when your next unannounced audit will be? And can a site refuse entry to an auditor? In this Q&A, Jane Pappin of Cert-ID provides some answers.

Food companies are now handling and preparing for increased number of inspections and audits. Food safety rules under the Food Safety Modernization Act have proposed unannounced audits of food facilities as a way to include another level of security to ensure that these facilities are compliant with the various standards. Such audits, regulators hope, will give a more realistic picture of compliance, rather than facilities appearing to comply just the day of the inspection.

Food companies that have been abiding by all the requirements of the specific food safety standard don’t have to do anything differently than what they have been doing all along, says Jane Pappin, Certification Director at Cert-ID: “If they have a strong food safety and quality management program in place, have been conducting regular internal audits, and gap analysis etc., they shouldn’t have anything to worry about. The auditor is not going ask anything that they would be unprepared for,” she adds.

We present below excerpts from a Q&A with Pappin.

Q: How will my site know if our next audit is unannounced or not?

A: SQF has indicated that the Certification Body (CB) is responsible for telling the site when their unannounced audit will be. As the CB is charged with reminding the site of their upcoming renewal audit approximately three to five months in advance of the re-audit due date, the site could be informed then.

Once the site is told when their unannounced audit will be, there is opportunity to negotiate black-out dates – these are only for days when the site will not be in production. The unannounced audit will always take place within the site’s renewal audit window, which is from 30 days before the site’s re-audit due date (which is listed on your certificate) to 30 days after the re-audit due date. 

A site must have one unannounced audit per three-year cycle. For those sites already certified, their first unannounced audit will take place either in 2014 (from July 3 to Dec 31), 2015 or 2016 and they will be informed by their CB which year it will be in. Their second unannounced audit will take place in either 2017, 2018 or 2019, and so on. Once your unannounced audit year is determined, this will be recorded in SQF’s Reliance Database. Even if you change CBs, this information will go with your facility’s profile and your unannounced audit year will not change.

Q: What happens if the auditor arrives for the unannounced audit and the site refuses entry?

A: The ramifications of disallowing the auditor entry to your facility are far reaching: First, you will still be charged for the visit, including auditor expenses. Second, your facility will immediately be put into suspension. Third, an announced audit must now take place no later than 30 days from the date you denied entry to the auditor. If this doesn’t happen, your certification will be withdrawn. Fourth, because you were put into suspension, you will also be required to have a surveillance audit six months after the 30 day audit. Fifth and last, your next audit will then be your unannounced audit.

What’s Changing with Nutritional Labeling and Serving Sizes?

By Michael Biros
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Bailey Pudenz, Nutritional Coordinator at Eurofins Nutrition Analysis Center, explains what the proposed changes are, and how the labeling would need to change under the new requirements.

FDA has proposed changes to the current nutritional labeling. Currently both the proposed nutritional labeling and serving size rules are in comment period which will close June 2, 2014. Once the final rule is published, it will become law 60 days after the publication date. Industry will then have two years to achieve compliance.

Calories

Calories, calories from saturated fat, the 2000 calorie reference, and percent daily value for calories will remain the same. However, calories from fat will be removed completely. FDA wants consumers to be more aware of the amount and type of fat they eat rather than the calories the fat contributes.

Fat

Total fat, saturated fat, trans fat, poly and monounsaturated fat, and cholesterol will remain the same. FDA considered changing the cutoff value for declaration of zero trans fat, but they have chosen not to change this either. Currently this value is 0.5g per serving. Anything less than this can be declared as zero. FDA is not allowing mandatory or voluntary declaration of the omega-3 fatty acids, EPA and DHA.

Carbohydrates

There are no proposed changes to mandatory declaration or daily reference value for total carbohydrates. However, FDA has proposed changing the name to total carbs. Other carbohydrates, such as starches, are no longer allowed to be voluntarily declared on the label.

FDA is also proposing to change the calories from carbohydrates calculation. The calories from carbohydrates would then be used to calculate the total calorie content in the product. This proposal would exclude soluble and insoluble non-digestible carbohydrates from the calculation. Calories from carbohydrates would then be calculated using 4kcal/g less the amount of non-digestible carbohydrates. Soluble carbohydrates will then be added at a value of 2 kcal/g.

Sugars

There are no proposed changes to mandatory declaration or daily reference value for sugars. However, the name will be changed to total sugars and and a new category of added sugars will be mandatory to declare. FDA has developed an extensive list of what is considered an added sugar: brown sugar, corn sweetener, corn syrup, dextrose, fructose, fruit juice concentrate, glucose, high fructose corn syrup, honey, lactose, maltose, malt sugar, molasses, raw sugar, turbinado, sugar, and sucrose. FDA acknowledges that there is no analytical method available to determine added sugars and will rely on ingredient records to determine the amount and type of added sugars. There are no proposed changes to sugar alcohols.

Dietary fiber

Dietary fiber will still be mandatory to declare, however FDA is proposing to increase the daily reference value to 28g per day. They will adopt the Institute of Medicine’s definition of total fiber which focuses on fiber that is beneficial to human health. There are no proposed changes to soluble or insoluble dietary fiber. 

Protein and Sodium

There are no proposed changes to protein. Sodium is still mandatory to list and FDA is considering lowering the daily reference value from 2400mg to 2300mg.

Essential Vitamins

Vitamins A and C will no longer be mandatory to declare on the label, but can still be voluntarily listed. Vitamin D will be mandatory to declare. FDA has proposed changing the units for vitamin A from IU to µg RAE (Retinol Activity Equivalents) and for vitamin D from IU to µg.

Vitamin K, vitamin B6, vitamin B12, thiamin, riboflavin, biotin, and pantothenic acid will still be voluntary to declare. FDA is proposing the voluntary labeling of choline. The units for vitamin E will be changed from IU to mg. Folate/folic acid will still be voluntary, but they will no longer be interchangeable and the units will be changed from µg to µg DFE (Dietary Folate Equivalents). Niacin is still voluntary to declare, but the units will be changed from mg to mg NE (Niacin Equivalents).

Vitamins
Current RDIs
Proposed RDIs
Biotin
300 µg
30 µg
Choline
550 µg
550 µg
Folate 
400 µg
400 µg DFE
Niacin 
20 mg  
16 mg NE
Pantothenic Acid 
10 mg  
5 mg 
Riboflavin 
1.7 mg 
1.3 mg 
Thiamin 
1.5 mg 
1.2 mg
Vitamin A 
5000 IU 
900 µg RAE
Vitamin B6 
2.0 mg 
1.7 mg
Vitamin B12 
6 µg 
2.4 µg
Vitamin C 
60 mg 
90 mg
Vitamin D 
400 IU 
20 µg
Vitamin E 
30 IU 
15 mg
Vitamin K 
80 µg 
120 µg

Essential minerals

Calcium and iron will both remain mandatory to declare. It will be required to declare potassium. 

Phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, and chloride will still be voluntary to declare. Fluoride will be voluntary to declare and FDA is not defining a daily reference value. 

Minerals
Current RDIs
Proposed RDIs
Calcium
1000 mg
1300 mg
Chloride
3400 mg
2300 mg
Chromium
120 µg
35 µg
Copper
2.0 mg
0.9 mg
Iodine
150 µg
150 µg
Iron
18 mg
18 mg
Magnesium
400 mg
420 mg
Manganese
2.0 mg
2.3 mg
Molybendum
75 µg
45 µg
Phosphorus
1000 mg
1250 mg
Potassium
3500 mg
4700 mg
Selenium
70 µg
55 µg
Zinc
15 mg
11 mg

Serving sizes

Changes to RACCs (Reference Amount Customarily Consumed) were proposed if consumption data increased or decreased by 25 percent or more. Based on this, about 17 percent of the RACCs will change. FDA will also be adding 25 new RACC categories. Changes in the RACC can potentially change claims such as “low fat” or “a good source of calcium.”

FDA has proposed specifications for how to determine servings per container. Products containing 200 percent or less than the RACC are considered a single serving. Products containing 200-400 percent of the RACC can be labeled with dual columns (single serving and per container). Products with more than 400 percent of the RACC are multi-serving.

  

Nutrition Labels – Old and New
Nutrition-Label-Old-May-2014 Nutrition-Label-New-May-2014

Formatting

Calories and servings per container will be increased in size. The location of servings per container and serving size will be switched. Serving size will be right justified. The phrasing of amount per serving will be changed to include the serving size. Calories from fat will be removed. Percent daily value will be located on the left side of the label. Added sugars will be included below sugars. Mandatory vitamins and minerals will have quantitative amounts in addition to percent daily value. FDA is requesting comments on how the footnotes should be adjusted.

Bob Savage, President and Founder of the HACCP Consulting Group

FSQA: Creating HACCP Excellence

By Michael Biros
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Bob Savage, President and Founder of the HACCP Consulting Group

For a successful Food Safety and Quality Assurance program, there must be management commitment and measurable expectations set. Senior management has to be committed to the program. They are the foundation for everything in food safety. They have to provide resources to develop and implement the plans across different departments as well as provide for training and encourage communication, advises Robert A. Savage, President and Founder of The HACCP Consulting Group.

Sharing some lessons learned from decades of HACCP implementation experience, Savage spoke at a recent webinar on FSQA: Creating HACCP Excellence, presented by SafetyChain Software. We present excerpts below. 

A few years ago, there was a very serious Salmonella outbreak in peanut butter. It appears that company shopped around for negative salmonella results and then shipped the product. It’s a worst case scenario, but in this case, short term profitability at the expense of food safety resulted in the over 600 illnesses and a few deaths as well as the bankruptcy of the company, described Savage.

Role of GMPs in Creating and Minimizing CCPs

Without good GMPs, facilities tend to have more CCPs than necessary. There has to be a good balance between GMPs and CCPs. When companies understand the the relationship between HACCP, GMPs, and CCPs, typically the HACCP plan would not have more than 3 or 4 CCPs and everything else is covered by GMPs. 

Best practices for HACCP management must be committed from the beginning and throughout the process. GMPs should be in place prior to even beginning to revamp the HACCP plan. Multidisciplinary HACCP teams, including QC, QA, Lab, Sanitation, Product Development and Sales, experts, should contribute to the process in developing the plan. Having a multidisciplinary team helps with achieving buy-in or company-wide commitment to the plan. 

Companies have been pretty good with monitoring, but there’s still some confusion between verification and validation. Verification is a check of the checkers. When CCPs are identified and monitored, verification is making sure that the company says what it’s doing and is doing what it says. Validation asks if the company has the right CCPs and how can they prove it. 

Best Practices for Audit Prep

USDA regulated plants have routine inspections to verify what the companies do on an everyday basis. Separate from these routine inspections, USDA also performs food safety assessments which can take days or weeks to complete. Companies under USDA jurisdiction should do their own food safety inspection to prepare for these FSIS audits. FDA regulated plants may go months or years between inspections. These facilities should have third party audits such as SQF or other audits. 

GFSI schemes have taken hold in the US and around the world. The popular one in the U.S. is SQF. Companies that meet SQF standards should have no problem meeting new FDA FSMA regulations.

Is Your Document Control System Effective?

By Food Safety Tech Staff
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This article describes eight traits to look for in a good Document Control System, and the overlying benefits that can be reaped from using Document Control to drive compliance in your processes.

Document Control is one of the most common applications in compliance today. It allows an organization to manage the creation, approval, distribution and archiving of all controlled documents and processes. It is an integral part of Quality, Environmental Health and Safety (EHS), or Compliance Management systems. This is because in order to effectively maintain consistency in processes, job descriptions, work instructions, and more, an organization needs to ensure that records are controlled. It also keeps tasks on track and ensures that they are accomplished on time. This article describes eight traits to look for in a good Document Control System, and the overlying benefits that can be reaped from using Document Control to drive compliance in your processes. 

Eight characteristics of an effective Document Control System

1. Workflows for All Document Types: No two document types are alike. There are differences within each that should be taken into consideration. For example, a job description cannot be treated the same as a work instruction or procedure. Each of these types of documents may have separate approvers, managers, and workflows and should be handled in a unique manner. A good Document Control System can automate and manage documents efficiently. A great Document Control System can facilitate dedicated workflows for all document types, each complete with their own routing options.

2. Ability to Configure Metadata: When in the Document Control form, one of the critical aspects is the ability to segment that data and describe the type of document. This is accomplished through metadata, which is essentially a high level description of each document. It assigns a department that the document is associated with, describes priority level, ISO elements, and records specific information. Metadata also helps to categorize and report on data. It helps to search and filter so it can be found in the system and categorized. The key for an organization is to find a system that will allow it to configure metadata based on document type, in a flexible manner. This will allow them to change fields, add categories, keywords, and more. This configurability within Document Control forms is critical to adapt the Document Control System to meet unique business needs.

3. Integration with MS Office Documents: The majority of organizations use Microsoft Office to manage most of their documents and files such as Word, Excel, and PowerPoint are still the standard for creating documents within businesses today. Therefore, the ability for a Document Control System to work well with MS Office is an important distinction. This way, an organization can preserve the metadata and sync both components. If a change is made in the Document Control form, it is reflected in the Word file, and vice versa. This integration links the two components together, so that one is never inconsistent with the other. 

4. Intelligent Business Rules for Review and Approval: The power of an automated Document Control System lies in its ability to route documents along the workflow. Documents can’t just be checked in or out, there needs to be a process of approval and review as well as document sign off —it has to go through different phases of workflow. This makes flexible routing options a necessity in a Document Control System. A good Document Control System enables organizations to route documents to the next phase in the workflow, but also has intelligent business rules associated. 

5. Integration with Employee Training: A critical component to any Document Control System is that if a new document is created or an existing document is changed, people need to be trained. This is a vital reason for having Document Control process. During revision or creation of a document, the user should be able to specify the type of training associated with it. A bonus is the ability to automatically integrate training. Some companies include a “waiting release” phase. This means that before the document is released, it is out in a holding pattern—this is when training happens. The benefit is that employees can train on the document before it is released to world, so that when the document is released employees are already trained and knowledgeable on it. Some systems automatically have a Training System built into Document Control, which allows them to integrate Training with Document Control and to test their knowledge on that document. Ultimately, when there are changes made to any document, employees need to be apprised of new procedures and specifications and trained on any new revisions that are released. This process should be automated—manual tracking and training processes leave room for error. A Document Control System integrated with the Training application helps to easily define who needs training on each document. It also automatically updates training records for each employee, allows for self training, and automatically updates each employee status upon training completion. 

6. Change Request and Revision Control: Document Control is a continual process. Once documents are created and approved, there will most likely be changes made in the future. Change control and revision control in itself should be a workflow to ensure controlled access of all documents and changes to documents. A good Document Control System will have its own change request workflow that includes revision review and approval. It will also hold the original document until the new document is changed—once the new document is approved, it will take the old document’s place. Sometimes an organization will have changes that affect multiple documents. In this case, the system should be able to make a global change. This allows an organization to make multiple document changes within the same workflow and will show all documents to be changed, all affected areas, and where it will be changed. This is important because when making changes to a document, other documents may be involved or affected. A good Document Control System includes a multi-document change request that will save time and resources for the company. 

7. Reporting: When an organization has a lot of documents and data going into the system, it needs visibility to look at that data in a meaningful way. Using metadata can help by filtering documents by phase, keyword, and more. Having a system to filter data this data is key. Good Document Control has reporting engines built into, or tied to it. This allows the system to quickly and effectively look at data on aggregate level, and run ad hoc reports, scheduled reports, and template reports on the health of the Document Control System. People want to be apprised of where overdue documents so they can take steps to fix them. Reporting provides this visibility.

8. Intuitive Filtering and Data Security: Within any system, the ability to ensure secure data and documents is critical. An organization wants to make sure that appropriate levels can access, approve, review and make necessary revisions to the document. A good Document Control System will have the security in place that will allow the organization to filter each document to appropriate security levels. In multisite, centralized systems, filtering and securing data often becomes a concern. An effective Document Control System lets an organization limit data visibility to only what is necessary to the user. Depending on the access level of the user, the visibility of documents will change. This ensures that an organization can operate in their Document Control System safely and securely.

Summary

The Document Control System is major information hub for the Quality system and sets the foundation for doing business in a compliance context. It sets the policies, the practices and the enforceable regulations that drive the company’s Quality and EHS initiatives. A good Document Control System will intelligently automate the review and approval process. It will link documents and records so that information is easily transferred, and will foster a platform for intelligent business rules and change management. It allows the integration of Document Control with the Change Management System to simplify change requests and allow single revisions; with Employee Training to efficiently train employees on new documents; and with Deviations to ensure that employees are aware of any planned deviations and these are tracked to completion. The eight traits of an effective Document Control System, combined with the overreaching benefits of the quality system, provide a holistic system for managing documents and extending to the other crucial areas of the enterprise. The QMS is the guide to making sure this is done as easily and effectively as possible.

The above article has been adapted from a white paper by EtQ, Inc. 

FSMA: What’s the Latest, and What Do You Need to Know

By Michael Biros
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Is your company ready for ‘TACCP?’ Do you know how long you will be required to retain your records? Is your carrier up-to-date on the sanitary transportation section of FSMA? Dr. Bob Strong, Senior Food Safety Consultant at SAI Global, gives an overview of the newest updates on FSMA.

Questions were raised recently by brewers and distillers about spent grains being sold as animal feed. FDA recognizes that hazards will be minimal, but charges facilities with protecting spent grains during storage awaiting collection and during transportation as required under FSMA Section 103. This will require protection against physical and chemical contamination and references the inadvertent addition of industrial waste oil to used fryer oil that exposed 100,000 chickens to PCBs. The comment period for this is closed and the final rule is expected to be published this summer. The final rule is scheduled to take effect by August 30, 2015.

Record retention and availability applies to anybody who processes, packs, transports, distributes, receives, holds, and imports human or animal food. However, farms, restaurants, USDA plants, personal consumption, non-food packaging, and food contact packaging manufacturers (but not users of this packaging material) are exempt from this requirement.

The length of record retention depends on the perishability of the food product. If the shelf life is less than 60 days, both the handler and transporter must retain records for 6 months. If the shelf life is between 60 days and 6 months or if the food is animal/pet food, both the handler and transporter must retain records for 12 months. If the shelf life is greater than 6 months, the handler must retain records for 2 years, but the transporter must retain records for only 12 months. Records must be available within 24 hours of a request by FDA and civil action may be taken if records are not kept or made available. This final rule was published on April 4, 2014.

FSMA section updates

These updates are confined to Section 106 — Intentional Adulteration of Foods; Section 111 — Sanitary Transportation of Human and Animal Food; and Section 204 — Designation of High Risk Foods Relative to Record-keeping for Traceability.

To recap, FSMA does not apply to facilities regulated by USDA (meat, poultry, and eggs). Also exempted are juice manufacturers, seafood processors, alcohol-related facilities, low-acid canning (except to expand their hazard analysis), and small businesses.

FDA is considering modified requirements for warehouses and having Preventative Controls only if they are storing refrigerated products.

Section 106 — Intentional Adulteration of Foods

The intent of the proposed rule is for companies to begin using a “qualified individual” to develop a written food defense plan. This plan will protect against intentional adulteration of food for the purpose of causing harm to consumers. The plan should focus on actionable process steps, mitigation strategies, monitoring, corrective actions, and verification.

The regulation exempts very small businesses, companies with a majority of sales to very small businesses, storage facilities (except for bulk liquid storage), alcoholic beverage manufacturers, and animal feed manufacturers and distributors.

Actionable areas and mitigation strategies:

Key actionable areas identified by FDA include: bulk liquid receiving and loading, bulk liquid storage and handling, secondary ingredient handling, and mixing and similar activities. Deliberate acts of contamination may come from acts of terrorism; disgruntled employees, consumers, or competitors; or economically motivated adulteration such as the melamine tainted milk incident.

Companies must identify and implement mitigation strategies, establish procedures to monitor these strategies, implement corrective actions, verify that monitoring is being conducted, train supervisors assigned to actionable process steps, and maintain records.

Examples of mitigation strategies include restricting access to potential adulteration points such as loading and receiving areas, bulk liquids, secondary ingredient handling rooms, and open processing points. Facilities must require tankers to be sealed after loading and the seals must be checked at receiving.

TACCP

FDA is asking for comments on using HACCP principles to develop food defense plans. They are considering calling a control point a TACCP (Threat Assessment Critical Control Point). They are also trying to identify the risk of adulteration to specific processes. Some examples of low risk foods that are hard to adulterate are: shell eggs, whole produce, game meats (not ground), peanuts/tree nuts, and sugar cane/beets. FDA has extended the comment period through June 30, 2014. 

Section 111 — Sanitary Transportation of Human and Animal Food 

This section builds upon the previously issued Sanitary Food Transportation Act of 2005. It has five major sections: vehicle and transportation equipment, transportation operations, information exchange, training, and records.

The regulation exempts shippers, receivers, and carriers that have less than $500k in total annual sales; the transportation of raw agricultural commodities by farm vehicles; food being shipped through the US to another country; food imported to be exported, but not consumed in the US; shelf stable foods that are completely enclosed in a container; the transportation of compressed gases; and the transportation of live animals.

Vehicles and transportation equipment

The proposed rule will establish requirements for the design and maintenance of vehicles and equipment to ensure that they do not cause contamination of the food being transported. This includes bulk and non-bulk containers, bins, totes, pallets, pumps, fittings, hoses, gaskets, and loading/unloading systems.

The regulation identifies the potential for cross-contamination from: incorrect use of packing materials (reusing wood containers for produce that once held raw meat); using the same hoses or pumps with different allergens or raw and ready-to-eat products; and pallets in poor condition (splintering or projecting nails).

The proposed rule will establish requirements for cleaning, inspection, maintenance, loading/unloading, and operation of transportation equipment to ensure no contamination or temperature abuse of the products during transport. This includes the growth of spoilage bacteria as well as pathogenic bacteria. This will be achieved by ensuring adequate temperature controls, separation of foods with different temperature requirements, and the cleanliness and physical condition of trailers, tankers, pallets, etc.

Communication

Carriers, shippers, and receivers will be required to exchange information regarding prior cargos, the cleaning of bulk transportation equipment, and temperature controls. A log of prior loads must be kept. FDA will not restrict what can be hauled. Rather, they will regulate the cleaning between loads. Wash tickets must be kept and shared with customers. Washing may include sanitizing where necessary.

The carrier must communicate with the shipper and receiver that temperature sensitive foods were transported under the required temperature conditions. This requirement can be waived for short hauls or if the shipper loads a temperature recording device with the shipped products. The shipper and receiver are required to specify in writing the temperature requirements to the carrier. The receiver must confirm compliance.

Training, records and waivers

Carrier personnel must complete training in sanitary transportation practices and must have documentation of this training. This will include personal hygiene for drivers and loading/ unloading workers, training in security, accessibility to hand washing, and avoiding cross contamination in handling mixed loads. Procedures, training, cleaning, prior cargos, and temperature control must be recorded and properly maintained.

Shippers, carriers, and receivers who hold valid permits and are inspected under the National Conference on Interstate Milk Shipments (NCIMS) Grade “A” Milk Safety Program may be waived from these requirements only when they are involved in shipping Grade A milk and milk products. Transportation of food relinquished to consumers may also be waived (such as the pizza delivery guy).

Section 204 — Designating High Risk Foods for the purpose of record keeping related to Traceability

This proposed rule designates high-risk foods based on known food safety risks. The criteria for modeling and scoring risk are:

  1. Frequency of Outbreaks and Occurrence of Illnesses: This must include chemical and microbiological food safety hazards. Chemical hazards include allergens, mycotoxins, pesticides, and heavy metals.
  2. Severity of Illness: This will take into account illness duration, hospitalization, and mortality.
  3. Likelihood of Contamination: This is based on number of recalls and contamination that has been known to occur.
  4. Pathogenic Growth Potential/Shelf Life: Strong growth potential is likely at temperature at which the food is intended to be held and stored, including refrigeration and room temperature. This will be coupled with shelf life where longer shelf life can increase risk.
  5. Manufacturing Process Contamination Probability/Intervention: High probability has recurring or frequent detection of contamination. Low probability has infrequent detection of contamination or where contamination is introduced post manufacturing. This will be coupled with the availability and implementation of control measures.
  6. Consumption: This is the percent of the population that consumes the food.
  7. Economic impact: Lower is defined as $100-500k impact per year and higher is greater than $10m per year.
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.