Dr. David Acheson is the Founder and CEO of The Acheson Group
Beltway Beat

Final Preventive Controls Rules – Devil in the Details?

By Dr. David Acheson, Melanie J. Neumann
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Dr. David Acheson is the Founder and CEO of The Acheson Group

As we review the general applications and requirements for the first two final rules of FSMA (Preventive Controls for Human Food and Preventive Controls for Animal Food), we’re not seeing a big departure from the proposed preventive controls. But with nearly 1,600 pages of reading, we may not have found all the changes yet. Areas of note include: For the first time in history, training is now a regulatory requirement; and a new definition for a “preventive controls qualified individual” that is separate and distinct from the “qualified individual” under the proposed rule. With further analysis of the rule to come, we fully anticipate the devil to be in the details.

In this first article on the final rules, we are pulling out the key points, providing a general perspective of the Preventive Controls for Human Food, and main elements and compliance dates for both Preventive Controls rules.

The Human Food Rule

FDA has emphasized that it has built more flexibility into key requirements of the Human Food rule, including giving facilities the flexibility to consider the nature of the preventive control, the facility, and the its food safety system when establishing the appropriate preventive control management strategies (e.g. monitoring, verification, validation, corrective action).  In addition, the definition of farms, which are exempt from these regulations, has significantly changed to reflect modern farming practices.

The agency views the rule as better protecting public health by adopting a modern, preventive, and risk-based approach to food safety regulation for the future in three key ways:

  1. It creates new requirements for facilities to establish and implement hazard analysis and risk-based preventive controls for human food.
  2. It modernizes FDA’s long-standing CGMP regulations, updating, revising, and otherwise clarifying certain CGMP requirements, which were last updated in 1986.
  3. It clarifies the scope of the exemption for “farms” and makes corresponding revisions to regulations for the establishment, maintenance and availability of records.

The rules generally apply to establishments that are required to register with FDA. Key elements of the rule are as follows:

  1. Facilities must implement a food safety system that includes an analysis of hazards and risk-based preventive controls, including a written food safety plan that integrates hazard analysis of known or reasonably foreseeable biological, chemical, and physical hazards; preventive controls for processes, food allergens, and sanitation, supply-chain controls and a recall plan; and oversight and management of preventive controls to include monitoring, corrective actions/corrections, and verification.
  2. The definition of a “farm” is clarified to cover two types of farm operations not subject to the preventive controls rule (however, farms that conduct activities covered by the Produce Safety rule are subject to that rule):
    • Primary Production Farm. An operation under one management in one general, but not necessarily contiguous, location devoted to the growing or harvesting of crops, the raising of animals (including seafood), or both. The final rule expands the definition to include facilities that pack or hold raw agricultural commodities grown on a farm under different ownership, and to those that solely harvest crops from farms.
    • Secondary Activities Farm. The operation is majority owned by the primary production farm but located separately and is devoted to harvesting, packing and/or holding raw agricultural commodities.
  3. A flexible supply-chain program with separate compliance dates. In general, a manufacturing/processing facility must implement a risk-based supply chain program for raw materials/ingredients for which it has identified a hazard requiring a supply-chain applied control – unless it or its customer controls the hazard using preventive controls according to the preventive controls rules.
  4. Updated and clarified Current Good Manufacturing Practices (CGMPs). In addition, some previously nonbinding provisions have become binding rules.
  5. A new “Qualified Individual” aka the “preventive controls qualified Individual.” This is a more highly qualified position/level in the organization with responsibility to perform the hazard analysis and assign preventive controls, defined under the rule as “a person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA or is otherwise qualified through job experience to develop and apply a food safety system.” The qualified individual is based on education/training as applied to the individual’s assigned job duties—with the assumption that each individual will be a “qualified individual” for his/her assigned role.
  6. Training is a requirement. Foremost is the training required for the preventive controls qualified individual and qualified individuals. Further training may be required under Proposed §117.135(c)(6)–Other Controls, which proposes that preventive controls include any other procedures, practices, and processes necessary to satisfy the requirements of §117.135(a).

The Animal Food Rule

In addition to key elements similar to #1–3 of Human Food (above), this rule:

  1. Establishes CGMPs for animal food production by which facilities that further process a by-product for use as animal food must do so in compliance with CGMPs, but can follow either the human food or animal food CGMPs.
  2. Does not apply to feed mills associated with fully vertically integrated farming operations that generally meet the definition of a farm. However, because FDA expressed concern that this leaves a food safety gap, it plans to publish a proposed rule in the future to require that some feed mill operations implement the CGMPs established by the Preventive Controls for Animal Food rule.
Camila Gadotti, 3M
In the Food Lab

Examining the Role of Food Safety During R&D

By Camila Gadotti, M.S.
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Camila Gadotti, 3M

Research and development (R&D) is an essential starting point toward the creation or modification of new and exciting food products, processes and packaging. To ensure that a product is safe for consumption, food safety should be considered during the initial stages of a product’s lifecycle. Incorporating food safety into R&D can be tricky, as safety considerations may change the initial idea or concept of a new food product. For example, the idea of a freshly squeezed orange juice in every supermarket shelf is appealing; however, without pasteurization, that juice will not be safe for consumption, nor will it have the desired shelf life. Adding raw chopped garlic to a hummus product makes it taste great, but will it be safe for consumption after being on the shelf for a month?

To better understand how safety of new products is assured from concept to launch, I spoke with two R&D scientists about food safety considerations during new product development. The interviewees, Maria and Laura, work for the same large food manufacturer, which is located in the Midwest, in the snack foods and breakfast cereals categories, respectively. They both confirm that the R&D team follows a specific procedure during the product concept phase—one that places food safety at the forefront. The team starts by determining how the new product compares to food safety regimens already in place with other products that the company manufactures. If the product is a line extension with only a few changes to an existing formulation, the food safety concerns are likely to be low, and the food safety program already in place is adapted to meet the safety needs of the new product. However, if the product being developed is highly differentiated from other products manufactured by the company, food safety moves into a more central role throughout the development cycle.

According to Maria and Laura, the first step in ensuring food safety for a new product is for the development scientists to have in-depth discussions about the product’s formulation, ingredients and supply sources. These three aspects, along with the planned manufacturing process, are then evaluated through a hazard assessment. The hazard assessment is comprised of microbiological, quality, regulatory, stability and physical hazard assessments. Ingredients that pose food safety concerns without prior controls and process conditions are identified. The quality team determines controls for these ingredients and subsequently involves process engineers to verify that process conditions are attainable and will provide proper control for the hazards identified. A complete HAACP plan is put in place for the new product production, taking into consideration equipment cleanability and location, traffic control for ingredients and operators, and air handling systems. The hazard assessment is documented in detail and must be approved by the quality manager before production runs can begin and development can resume. Although the entire process is led by R&D, multiple other functions are involved and consulted throughout the process.

Manufacturing processes, formulation and market availability of ingredients drive the food safety of a new product, with manufacturing processes and formulation usually being the key drivers. “However, in cases like the recent shortage of eggs due to the avian flu crisis, finding substitutions for ingredients in shortage becomes an important driver for food safety,” says Maria. Laura says that at times, product formulations can change due the integrity of the ingredient or its source. In such cases, a similar ingredient from a credible source is chosen and the safety of the product is re-assessed. There are critical quality and food safety elements that must be considered in the product design phase to prevent issues later in development. When R&D professionals keep these elements top-of-mind when considering formulation and ingredient sourcing, everyone benefits—from the company to consumers.

Although consumer confidence in the safety of the U.S. food supply is slipping (11% said they were “very confident” in the safety of the food supply, down from 15% in 2013; 50% said they were “somewhat confident”, down from 55% in 2013, according to the International Food Information Council’s 2015 Food and Health Survey), the interview with Maria and Laura shows that manufacturers are putting significant effort into developing safe food products. It is equally as important for suppliers and vendors to have robust food safety programs to build strong relationships with manufacturers. Food companies have a lot to lose if a product they develop is, or becomes, unsafe for consumption. Not only can the average cost of a recall add up to $10 million in direct costs to a food company, lost sales and the impact to the company’s market value, brand reputation, and business relationships is major. Some companies never recover from the punch. Through taking the time to audit suppliers, screen new ingredients, and make robust prototypes, food companies can be more confident in the safety of their innovative new products as they go through the development process.

Deirdre Schlunegger, STOP Foodborne Illness
Food Safety Culture Club

Make a Difference During Food Safety Month

By Deirdre Schlunegger
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Deirdre Schlunegger, STOP Foodborne Illness

The end of the summer is near. Children are back in school, holiday plans are on people’s minds, and National Food Safety Month is upon us, with an abundance of ideas for helping our families and friends stay safe. Even Global Handwashing Day is October 15. Who knew? There are many tips available for consumer awareness and multiple conferences for professionals in the food safety industry. Food Safety Month provides a reality check, reminding all of us that accountability lies with everyone, from the farm to the kitchen table. I am grateful that STOP Foodborne Illness has so many amazing volunteers who generously contribute their time and passion, sharing their experience with the food industry. Everyday companies tell us that adding stories at the beginning of a presentation makes an enormous difference for employees. Starting mandatory training with a personal account of foodborne illness grabs people’s attention—they sit up and take notice. It demonstrates that risks are real and that individuals do make a difference each time they follow safety guidelines and implement critical interventions.  

Your diligence and commitment make a difference every day.

Recently at the IAFP conference in Portland, Dr. Robert Tauxe, deputy director, Division of Foodborne, Waterborne and Environmental Diseases at the National Center for Emerging and Zoonotic Infectious Diseases commented (and I am paraphrasing) that there is a challenge in measuring one’s effectiveness when it comes to food safety; how do you know when you have prevented an illness?  

We are immensely proud of our work and ability to provide volunteers and staff members to speak at company events or be part of an orientation or a food safety video.  We are proud to work with The Kroger Company, Wegmans, Walmart , Kwik Trip, FDA, FSIS and others who see the value in bringing the personal story forward.

That is how we make a difference.

Guidance and regulations are critically important. And individuals working in companies who get it and understand the importance and consequences of doing the right thing—regardless of requirements—those who embrace a food safety culture, these are the people who ultimately make the biggest difference.

Thanks for all you do for food safety.

Randy Fields, Repositrak
FST Soapbox

How to Button Up Your Supply Chain

By Randy Fields
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Randy Fields, Repositrak

Donald Bowersox, a long-time business professor at Michigan State University and one of the progenitors of modern supply chain management, once said, “The job of supply chain is clearly a senior management challenge, and it’s one that sits right alongside the other C-level jobs in the corporation. We may call it something different going forward, but basically it will remain the stewardship of moving products from the material origin points all the way through the process of conversion to the end consumers efficiently, effectively, and relevantly. That challenge is a big one and will continue to be for a long time. So I don’t see a next organizational evolution. Instead, I see the supply chain manager becoming more deeply involved in the corporate strategic initiatives and being part of the C-team management.”

Applying this approach to food safety in the supply chain has become more critical during the last few years as a result of regulatory, market and consumer pressures. At the start of this century, only 15 years ago, the food safety director rarely, if ever, interacted with the CEO. Many retailers didn’t even have such a position, or it was combined with quality control or loss prevention.

Now, not only does the top food safety manager have the ear of the CEO, he or she is engaged with all senior executives. Part of this is the result of the Food Safety Modernization Act, which holds those officers personally liable for a wide variety of preventable incidents. Likely bigger causes for the shift are the changing market and the changing consumer, which both relate directly to the company’s brand reputation. And in the food business, everything starts and stops with the supply chain.

Why? Because the supply chain is ground zero for the failures that are responsible for causing food safety problems. And the supply chain is where food safety problems are prevented. It is the choke point or series of choke points that allow or prevent spoiled and tainted product from getting to the consumer. It is also the process by which that unsaleable product is reclaimed so as to ensure it never enters the marketplace.

It is critical for the food safety manager to work closely with the merchandisers and the store operations teams, as they have the relationships with suppliers and work to ensure that standards for everything from ingredients to production are met with every shipment. But it’s even more critical for those professionals to work closely with the supply chain team to determine weak links in the system and address those pressure points before they cause real damage. Without food safety-supply chain collaboration, the risks to a company’s reputation multiply. With it, the likelihood of a food safety incident reaching consumers diminishes tremendously.

It’s becoming clearer every day—if you don’t button up your supply chain, somebody else, namely the government or the consumer, will and the results won’t be pleasant.

Gina Kramer
Food Safety Think Tank

Activate Your Listeria Mitigation and Control Program

By Gina R. Nicholson-Kramer, Jeff Mitchell
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Gina Kramer

Listeria: It has been in the news and in our food throughout the past year. It has cost companies millions of dollars in recalls, shutdowns and mitigation; it has cost the government thousands of dollars in outbreak investigation, inspection and follow-up; and it has cost millions of dollars in medical bills for victims and for some, it has cost their lives.

I have asked Jeff Mitchell, vice president of food safety at Chemstar, to share his knowledge about Listeria mitigation and control, and to talk about the research that supports the innovative program that Chemstar uses with its customers.

Listeria Mitigation & Control Program

By Jeff Mitchell

Jeff Mitchell, Chemstar
Jeff Mitchell, Vice President of Food Safety, Chemstar

Thus far this year there have been several recalls of ready-to-eat (RTE) foods due to contamination with Listeria monocytogenes. Efforts to prevent contamination of food products with Listeria monocytogenes must be conducted at all levels of production. This is a difficult task given the fact that the bacteria is so widespread in the environment.  Focusing efforts in your process where contamination risk is of greatest concern to the consumer is important.  There is solid evidence that commercially prepared foods that have been contaminated with Listeria monocytogenes has occurred after the food product has been subjected to an initial lethality treatment. The product may be exposed in this area as a result of slicing, peeling, packing, re-bagging, cooling, or other procedures that may expose the product to potential contamination.

Listeria monocytogenes survives extremely well in food processing and retail food preparation environments. It may be introduced into your facility through a variety of routes, including:

  • Raw materials
  • Employees’ shoes or clothes
  • Equipment (boxes, crates, carts)

Controlling traffic flow into critical areas of the process can help reduce the chances of introducing and spreading the organism.

Once Listeria is introduced into the nonsterile environment, retail and factory conditions that promote its growth increase the risk of post-processing contamination. Several factors, including moisture, nutrients, temperature, competitive microflora and pH, affect the growth of Listeria in the food preparation and processing environment.  Moisture is the most crucial factor, as it is essential for microbial growth and is the most easily controlled of the factors.

Listeria tends to form a biofilm to enhance its survival when resident populations become established in the food prep/processing environment. The resident populations that are referred to as “persistent” are not easily eliminated by general cleaning and sanitizing procedures. Biofilm penetration is necessary for removal and inactivation of Listeria. The correct blend of chemical, contact time and agitation will aid in the removal. This combination dissolves the biofilm and the organic material to which it adheres, allowing the sanitizer to inactivate the released, sensitive cells.

 To learn more about Listeria from Gina and Jeff, check out their archived webinar with Food Safety Tech, Preventing Listeria Contamination: A Practical Guide to Food Safety ControlsBiofilm removal is important, because persistent L. monocytogenes can be dispersed from a biofilm into the environment and onto food processing equipment, and non-food contact and food-contact surfaces. Passive dispersal of Listeria can occur by aerosolization from high-pressure hoses or brushing; once aerosolized, Listeria can contaminate other growth niches in the food handling/processing area, eventually contaminating food contact surfaces and food. Another form of passive dispersal is the movement of processing equipment. If a biofilm is present, cells can be released by the movement or vibration of the equipment.

Inactivation of L. monocytogenes in biofilms is an important part of a Listeria control program. Understanding this face prompted our team to perform research with the University of Georgia using a mixed culture biofilm formed by Pseudomonas putida and L. monocytogenes to evaluate the ability of Chemstar’s foaming sanitizer to inactivate L. monocytogenes present in biofilms under realistic use conditions. The results revealed that it provides for a greater than four-log reduction.1

Identifying Listeria in the environment and eliminating the resident populations can reduce the risk of secondary contamination. Once these procedures are established, employee training and environmental monitoring are vital.  An effective Listeria control program requires that employees understand their role in mitigating the spread of Listeria, and management must relay those expectations. Control strategies are not likely to be effective if employees won’t cooperate, or don’t understand what they are expected to do, or why it is important, and that expected procedures or behavior will be monitored.

Reference

  1. Frank, J. and Mitchell, J. (December 3, 2010).  Evaluation of Chemstar foaming sanitizer for inactivating Listeria monocytogene in floor drain biofilms.
Join us for the Listeria Mitigation and Control Workshop at the Food Safety Consortium in Schaumburg, IL on November 17, 2015. Learn about the Five Key Elements in building an effective Listeria Control Program:

  1. Specific Sanitation Controls for Listeria
  2. Training of Personnel (they need to understand their role in the program)
  3. Traffic Control
  4. Targeted Environmental Monitoring and Testing
  5. Control Water Introduced into the Process Environment

The workshop will be a hands-on approach to learning about Listeria and practical solutions to take back and implement into your company’s sanitation program.
Dr. David Acheson is the Founder and CEO of The Acheson Group
Beltway Beat

A Mandatory GMO Labeling Ban—What Do You Think?

By Dr. David Acheson
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Dr. David Acheson is the Founder and CEO of The Acheson Group

We’ve said this already: 50 different methods for labeling U.S. food products just aren’t realistic from both a practical as well as a cost standpoint. Thus, it is not surprising that we continue to see activity in this space from Congress.

The latest round from Congress would pre-empt state efforts and put the responsibility on federal food agencies. The move is a result of the voice-vote passage of The Safe and Accurate Food Labeling Act of 2015 (H.R. 1599) by the House Agriculture Committee. This bill would stop state GMO-regulatory efforts and ban mandatory GMO labeling. FDA would also develop a non-GMO labeling standard, similar to that of USDA’s organic labeling.

The bill, which is a substitute amendment of the original bill, will go to the House (which is expected to pass it) and then to the Senate (where passage is less certain).

If approved by Congress and signed by President Obama, H.R. 1599 would:

  • Pre-empt state-level efforts to enact mandatory GMO labeling laws, overturning the state GMO-labeling laws recently passed and prohibiting local regulation of GMO crops.
  • Create a voluntary, consistent federal process of certifying and labeling food products as non-GMO, while prohibiting the mandating of labeling for all GMO foods.
  • Allow the Secretary to require labeling of a GMO food if “(A) there is a material difference in the functional, nutritional, or compositional characteristics, allergenicity, or other attributes between the food so produced and its comparable food; and (B) the disclosure of such material difference is necessary to protect public health and safety or to prevent the label or labeling of the food so produced from being false or misleading in any particular.”
  • Require that manufacturers have written FDA certification that a GMO product is safe.

While “right-to-know” activists are pushing GMO labeling, some on the other side are saying that this bill recognizes that right to know about a food’s origin and production is similar to the current labeling of organic foods. Rather than requiring that food manufacturers label their products as non-organic, the USDA National Organic Program allows approved products—and only NOP-approved products—to be labeled as organic. Similarly, as proposed in the bill, a standard to be developed by FDA would allow food manufacturers to label approved products—and only approved products—as GMO-free. Thus, like organic, those concerned with GMOs could purchase products fitting their needs.

This is an important difference, especially regarding the perceived safety of food products. Research conducted by the PEW Research Center reveals that although 88% of scientists from the American Association for the Advancement of Science say GMO foods are safe to consume, 57% of the general public believe these foods are unsafe. If more than half of your potential consumers mistakenly believe your product is unsafe, that would certainly have significant effect on your company’s business. Again, it is a similar argument as that of organic, where supporters often promote the food as healthier, despite USDA’s repeated assertion that “organic” simply means organic, not better or healthier.

In addition to the pro- and anti-labeling sides, the controversy has long been about who should have the authority. As we’ve said before, establishing state laws (i.e., those already passed by Vermont, Connecticut and Maine) would create a patchwork of rules, and food manufacturers would have to adapt to 50 different sets of laws.

Fundamentally, the consumers right to know what they are eating is not only understandable but, to me, totally appropriate. Where this goes off the rails is when it comes to complex labeling requirements and a push to require food companies to put information on labels that is nice to know but not critical to know. Regulations should be about protecting the consumer, and until (or unless) we have solid science indicating GMO foods are a problem that requires a warning, let’s keep mandatory labels where they belong and information for curious consumers in places where they can access it easily using modern technology.

In the Food Lab

New Technology a Step Forward for Pesticide Analysis

By Richard Fussell
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Scientists have been challenged by the capability limits of gas chromatography high- resolution mass spectroscopy (GC-HRMS) systems for years. There has been interest in a high-resolution accurate mass (HRAM) system with applications in food safety, and a new GC-HRMS technology for pesticide analysis indicates a step forward in GC-MS analysis.

Mass Accuracy Benefits

At the recent 1st International Symposium on Recent Developments in Pesticides Analysis in Prague, Hans Mol, Ph.D., of the RIKILT Research Institute and Jana Hajslova, Ph.D., a professor at the Institute of Chemical Technology, Prague, presented new data obtained using a technology called the Q Exactive GC system  based on GC separation, electron ionization (EI) and detection using a hybrid quadrupole-Orbitrap mass spectrometer. Mol described the system as a promising and complementary method to LC-Orbitrap that together enable new comprehensive workflows for quantitative analysis of targeted compounds and qualitative screening of non-targeted compounds for both GC and LC amenable pesticides. He also discussed the advantages of excellent mass accuracy (<1 ppm) for each scan across a peak in a complex matrix, at a resolving power (RP) of 60,000, and the simplicity of one acquisition event to obtain multiple accurate mass ions that can make use of existing EI-MS libraries.View videos of the symposium

Resolving Power

As sample types increase in complexity, the resolving power of the mass spectrometer becomes a key factor in reliable pesticide detection. A study that examines high-efficiency broad scope screening of pesticides using GC-HRAM details the mass accuracy, acquisition rate, linearity, detectability, accuracy, precision and identification capability observed at high resolving power. The experiment revealed that 60K RP (m/z 200, full width half maxima, FWHM) was needed to discriminate analytes of interest from matrix components and thus achieve reliable results for pesticides spiked into animal feed. The results indicate that the new system, when used with specific screening software, is an effective tool for routine screening of pesticides in food and feed samples.

Similar experiments for the analysis of pesticides in baby food again demonstrated that full scan acquisition at high resolving power (60,000 FWHM at m/z 200) provided a sufficient number of scans across individual chromatographic peaks to obtain excellent measurement precision over a wide linear dynamic range. Based on retention time (±0.1 min window), accurate mass information (±2 ppm window), ion ratios, isotopic pattern similarity (measured versus theoretical), and library search hit (NIST14 all 132 pesticides spiked at 10 ng/g were detected and identified in acetonitrile extracts of baby food.  Overall the Q Exactive GC system provided selectivity at least if not better than, and quantitative performance comparable to, GC triple quadrupole MS.

Different Pesticides Screening Methods

Hajslova also discussed the use of the Orbitrap technology in two different pesticide screening methods. The first approach focused on the targeted screen for pesticides from a customized HRAM database and a review of data using software. The second method involved non-targeted screening using deconvolution of accurate mass data and spectral library matching with identification using accurate mass fragments. When analyzing pesticides in whiskey samples, Hajslova commented that she was surprised that many compounds where automatically identified.  Since a non-targeted method involves full scan data, it allows the identification of compounds that would go undetected in a targeted method.

Screening using high-resolution mass spectrometry is an effective way to increase the scope of analysis. Routine resolving power of 60,000 FWHM eliminates matrix interferences, increasing confidence in results when screening pesticides in complex matrices. Consistent sub-ppm mass accuracy ensures confident compound identification.

Resources on GC Orbitrap MS Technology

Fast Screening, Identification, and Quantification of Pesticide Residues in Baby Food Using GC Orbitrap MS Technology. Demonstrates the quantitative power of a GC triple quadrupole MS combined with the high precision, full scan high resolution/accurate mass capability.

High Mass Resolution is Essential for Confident Compound Detection. Describes how sub-ppm mass accuracy accelerates the identification of unknown peaks by allowing the use of narrow mass tolerances to reduce the number of suggested elemental compositions.

The Power of High Resolution Accurate Mass Using Orbitrap Based GC-MS discusses consistent mass accuracy achieved across a chromatographic peak, at low and high concentrations, at low and high masses, and for various compound classes and matrix types.

 

FST Soapbox

HACCP, HARPC, and How Using Software Helps

By Steven Burton
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With nearly one in every six Americans falling prey to foodborne illnesses each year, food safety is a major public health issue. For several decades, current Good Manufacturing Practices (cGMPs) provided the basic food safety framework for manufacturers. However, these guidelines were not sufficient to cover all potential food safety hazards. In the 1960s, NASA asked Pillsbury to manufacture the first foods for space flights, and so the Hazard Analysis & Critical Control Point (HACCP) system was born. HACCP was later endorsed by the Codex Alimentarius Commission, which was formed by the Food and Agriculture Organization of the United Nations and the World Health Organization in 1963.

HACCP is a global standard and its principles are the defining elements of ISO 22000, BRC and SQF, all premiere global food safety standards. In 1996, an E. coli outbreak in Scotland claimed 10 lives. The Pennington report in the aftermath of this tragedy recommended use of HACCP by all food manufacturers to ensure food safety. While HACCP is mandatorily used for seafood, juice and USDA-regulated meat processing, it could not win universal acceptance across the food industry; most of the food industry sectors rely on cGMP for providing a food safety framework.

The number of people affected by foodborne illnesses can be attributed to a flawed food safety system. Thinking caps were put on and President Obama’s administration rigorously pursued what it hoped would be an effective food safety paradigm. On July 4, 2012 Hazard Analysis and Risk Based Prevention Control (HARPC) was introduced under FSMA section 103. Although the system is still a work in progress and FDA has yet not disclosed the regulations that will determine the functionality of HARPC, the agency is bound to issue the regulations by August 30, 2015. HARPC will become effective 60 days following this date, and companies will be required to enforce HARPC within a period of 12 to 36 months, depending on the size of a facility.

HARPC is designed along the lines of HACCP but is meant to be more comprehensive. For a “Simple Simon” it would be tough to differentiate between the two, but HARPC provides an all-encompassing food safety structure by focusing on preventive controls to make food safety more iron clad. With the exception of exempted facilities, HARPC will apply to all facilities subjected to FDA’s Bioterrorism Facility Establishment registration. All such facilities will be expected to enforce a functioning and adequate HARPC plan. Failure to do so and FDA would be authorized to take legal actions such as issuing a public warning letter or an import alert (in case of a foreign supplier), initiating criminal proceedings against a non-compliant facility, or suspending food facility registration of a facility until requirements are met. By doing so, FDA has put the onus squarely on the shoulders of respective facilities. Companies will be required to do a lot more and should expect deeper FDA involvement. Expert help to enforce a rather complex HARPC protocol seems unavoidable; there is a fair chance that users could find themselves lost in the translation and may end up facing FDA’s wrath if their plan is inadequate. Let me break it down a bit more and distinguish the main differences between HARPC and HACCP.

Qualified Food Safety Experience. HARPC requires one member of a company to be the qualified individual to complete an entire food safety plan. This means that said individual has undertaken education from a credible institution and gained experience by completing it. HACCP requires at least one person to be HACCP certified, but the plan must be constructed by a team of people.

Process Flow Diagram. Under the HACCP standard, food safety plans must include a clear flow diagram outlining the process, from start to finish, that the ingredients will take throughout your facility. HARPC has no regulations regarding this.

Hazard Variables. Traditionally, hazards were limited to biological, chemical and physical hazards under the HACCP paradigm. Yet, under HARPC, you must also outline Radiological and Terrorism hazards.

Controlling Hazards. Here is largely where the main difference lies: How to control a hazard. HACCP requires companies to mention their critical control points as well as outline a prerequisite program (PRP), although this has no set requirements. HARPC requires you to apply a sanitation preventive control to the hazards, which looks at monitoring, confirmation, corrective action, reviewing records and re-analyzing.

Reviewing the Plan. HACCP requires the individual in charge to review all HACCP documentation every year. This is in comparison to HARPC, which requires a facility to reanalyze its plan every three years.

Recall Plans. Recalls, as required under HARPC, are a special type of incident, with all of the attributes necessary to create and manage a recall plan. HACCP does not have such a requirement.

Use Software to Implement HARPC Plan

Using software can make life easier when it becomes time to implement a HARPC plan. Documentation is an important part of the HARPC system, and software can help generate most of the documents used to establish the plan. Such a system can link regulatory requirements with procedures and customize several aspects of the system during run time.

A risk analysis component of software helps a user identify the likelihood and severity of a particular hazard (a HARPC requirement). HARPC also requires sanitation control procedures at food surface contact points; software features can support cross contamination points to which hazards are assigned and controlled. Software also allows users to define equipment, with a facility to schedule and record calibration, maintenance, and verification activities, including management task assignment to satisfy HARPCs provisions regarding sanitation of utensils and equipment. In addition, it has the provision to document procedures as required by HARPC and can also flag employees for refresher training if they are involved in a violation.

Software also enables users to electronically record inspections, which satisfies the obligation under HARPC to carry out an environmental monitoring program (for pathogen controls). Interestingly, sensors could also be integrated with logging facilities to automatically collect sensor data, which could then be used to send out alerts if there is an abnormality. Software systems can also accommodate coverage of allergen hazards and run a food allergen control plan, including documentation of the process.

An incident management plan can assign and track corrective actions, root causes, employee retraining tasks, and preventive measures to individuals, and recall plans can be created and managed using the system. As many inspectors prefer remote review of documentation, software can provide such remote access, allowing inspectors to conduct off-site document reviews. This process can reduce on-site inspection times from five to three days. A list of approved suppliers can be maintained as well, and these suppliers can be linked to receiving functions, enabling users to receive and maintain a detailed and comprehensive record of ingredients.

HARPC is a reality that will have to be embraced very soon. Using software is a simple solution for the tough times that lay ahead for the food industry. It can serve as an all-encompassing and one-stop-shop for businesses that need help enforcing HARPC plans.

Deirdre Schlunegger, CEO of STOP Foodborne Illness
Food Safety Culture Club

A Haunting Refrain

By Deirdre Schlunegger
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Deirdre Schlunegger, CEO of STOP Foodborne Illness

In a meeting early this summer, I shared the story of a young girl who recently died from a foodborne illness and of the advocacy that her family has engaged in since that time. A person holding an important position in a food organization responded with assurance: “Well, we take a risk each time we walk outside.”  This string of words has become a haunting refrain. The tearful words of the families with whom each of us at STOP Foodborne Illness have spoken resonate.

I wonder if the person who spoke communally understands why their position exists. Why do any of us have jobs in food safety?  What happens in a food company when a senior employee subscribes to this philosophy?  Maybe the belief is that it can’t happen to them?  Does this organization need to experience it first-hand to understand it?  Will a consumer die as result of this philosophy?  Will the company suffer incredible financial losses?  Will the cognitive dissonance finally dissipate?  Will the company survive?

A comment like this is a reflection of a person and maybe of an organization that does not have a food safety culture. It’s a comment that is dismissive of food safety risks. When people eat food, they have a right to safe food. And companies have an obligation to manage risks—not simply be dismissive of them.

I know I am preaching to the choir to those of you reading this blog. You embrace, understand the importance of, and advocate for a food safety culture. You care deeply about your fellow human beings and about your company. But tell me, how would you respond to this comment?  How do you broadcast the why behind food safety?  How do you remember individuals who have been seriously ill, who live with long-term consequence, and who have died from foodborne illness?  How do you help others understand that risks must be mitigated throughout the food chain?

Thanks for taking the time to think about these questions and how best to answer them. A true food safety culture understands that there are risks, and the organization adopts a mindset that most food safety risks and outbreaks can be PREVENTED.

Unfortunately, some people will only embrace food safety culture once they’ve had a catastrophic event.

Please join us at STOP Foodborne Illness as we work to help others to proactively adopt a food safety culture to prevent outbreaks—not as a response to outbreaks.

Maria Fontanazza, Editor-in-Chief, Innovative Publishing Co. LLC
From the Editor’s Desk

Who Will Carry the Food Safety Torch?

By Maria Fontanazza
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Maria Fontanazza, Editor-in-Chief, Innovative Publishing Co. LLC

Each and every business in the food industry is facing a growing and daunting task: not just succession planning but also preparing for what could be an absence of qualified millennials entering the food safety profession.

At this year’s IAFP conference, the concern over professional development in this industry was at the forefront. “If we’re going to fill our shoes, where are the shoes walking?” asked Brian Bedard, executive director of the Grocery Manufacturers Association’s Science and Education Foundation. “How do we get young people excited about this profession? What are the programs we can get involved in to expose young people to this at a very young age?”

The question of how we are going to find passionate people to work in the food safety space, especially regarding the recruitment and training of millennials, is a big one. We need to make sure we are prepared to have the resources that will help build future success in food safety. In order to recruit those resources, we need to create more enthusiasm surrounding the field and make it a profession that people aspire to be a part of when they “grow up”.

“If we’re talking about the future…we need to get to the core of where people are making their life decisions and not waiting,” said Bedard. Yes, we need people with a Masters of Science degree in food science or nutrition, or expertise in microbiology and the like, but we also need people who know how a manufacturing or processing plant operates; we need people with knowledge about sanitary engineering and sanitary design, pointed out Bedard. With the changing landscape that we will experience with FSMA implementation, do you think we are armed with the resources to handle this paradigm shift as we look to the future?

Are we being proactive enough? How is your company working to invigorate the younger generation to become involved in this industry?