Eurofins Technologies, Gold Standard Diagnostics

Eurofins Technologies, Gold Standard Diagnostics Enter Strategic Partnership

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Eurofins Technologies, Gold Standard Diagnostics

This week Eurofins Technologies announced a strategic partnership with Gold Standard Diagnostics (GSD), a developer and manufacturer of fully-automated diagnostic instruments and assays for various test methods. The agreement unites Gold Standard’s ELISA-based instruments and Eurofins Technologies rapidly-expanding diagnostic test kit portfolio for  food, environmental and animal health testing.

Gold Standard Diagnostics will be the standard platform for Eurofins Technologies ELISA-based food testing kits including food pathogens, allergens, mycotoxins, veterinary drug residues, and animal health kits.

What To Consider When Developing A Facility Food Safety Plan

By Adam Serfas
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No two facilities will have the same food safety plan, as each should address the specific needs of that facility. Before beginning your draft, there are several critical factors to consider. Use the guide below as a checklist to review before starting or revisiting your own food safety plan—the following tips can be applied to all food and beverage processors and manufacturers.

1. Review current legislation that applies to your industry

The food safety sector evolves rapidly. Keep your finger on the pulse of updates and changes, whether current or forthcoming, to ensure that your plan is current and up to code. You can quickly familiarize yourself with guidelines and regulatory bodies dealing with your industry with a handful of excellent resources. Generally, we recommend starting with the FDA website, and from there you can navigate to resources that are specific to your industry. We also recommend you make use of the FDA’s Food Safety Plan Builder to assist you in meeting requirements for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation.

2. Identify current potential risks in your facility

Once familiar with your industry requirements and inspection standards, the next step is to identify any current potential food safety risks specific to your facility. Be sure to incorporate employees at all levels while detailing these potential hazards or concerns. Oftentimes, employees at the management level will make note of things different than employees working on the plant floor. And the delivery truck driver’s perspective will vary from those of your janitorial team. Aim to build a comprehensive list, noting everything from obvious high-risk areas, to what might be trivial or unlikely facility hazards. The more robust the list, the easier your food safety plan will be to form later on.

3. Consider your facility layout

Your facility’s physical layout often determines what type of food safety plan is necessary. Ask yourself:

  • Does your facility have natural zones?
  • Is it comprised of multiple buildings?
  • Are certain defined areas more high-risk than others?
    If you answered “yes” to any of these questions, you’ll most likely want to incorporate a zone-based color-coding plan as a part of your food safety plan to ensure that all of your tools remain in their proper location and are used correctly.

4. Review the quality of your current tools
Take stock of your current tools, that includes everything used to make or process your product and everything required to clean the facility itself. Consider the tool quality—are these presentable and acceptable for an inspector to see? Do your brushes have loose bristles? Has your mop seen better days? Tools that are made of low-quality materials or are not in top shape present potential risks for a food-safe environment. Note which tools need to be replaced and perhaps consider incorporating color-coded tools if you have not yet done so, as they are a great way to step up your food safety practices and safeguard against cross contamination.

5. Review and communicate the food safety plan and training procedures

Review your current employee training materials –in particular, your cleaning and sanitation measures and food handling procedures–and hold a meeting to go over current training protocols with your team. Consider the following questions:

  • Are the expectations made clear?
  • Are there references to procedures that are no longer up to date?
  • Is there appropriate signage that can be readily referenced?
  • Is information available for non-native speakers?
  • Are the appropriate channels in place for employees to voice concerns about these training procedures?

Be sure to take notes on each of these items that need to be addressed. One of the most important pieces of a food safety plan – and something inspectors pay close attention to – is that it is properly communicated to all employees. Taking detailed notes as you discuss these procedures will be helpful in documenting your training methodology for the food safety plan and, of course, will help you to ensure that the training procedures themselves are the best they can be.

6. Consider the documentation requirements for your industry.

Your industry might require certain specific documentation for your food safety plan, which can include facility policies, procedures, safety review records, maps and more. Additionally, some governing bodies require that the food safety plan is completed by a certified individual who doesn’t necessarily need to be an employee of the facility. Review all necessary requirements to ensure that you satisfy all of these standards for your next inspection.

Should you have any questions when getting ready to start on your plan, we suggest you reach out to a company that specializes in color-coding tools, as they have experience in creating plans to accommodate all kinds of identified risks and can be a great resource.

Megan Nichols

Important Restaurant Food Storage Safety Tips You Need to Know

By Megan Ray Nichols
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Megan Nichols

Safety is a priority when handling food. Don’t think of it as a chore to appease the health inspector. Food storage and safe handling can prevent your customers from getting sick. Whether you’re a veteran of the industry or just starting out, reviewing these tips can improve your restaurant’s operations and keep your guests safe.

Remember FIFO

FIFO, first in first out, should become your mantra when using stock. This rule governs stock rotation and use. When you receive a delivery, place the new stock behind the existing stock. Doing so reduces waste as you won’t have goods stored past their expiration dates. Use the stock at the front to always make use of the oldest products first.

Wood pallets, food storage
When receiving a new delivery, remember: FIFO. Image courtesy of Pixabay

Train your employees to track the expiration dates on all the goods in storage. A sheet listing the expiration of new and existing products easily shows this information. Stress the importance of using goods before their best by date for optimal safety and quality.

Keep Storage Dry and Dark

Dark, dry storage areas maximize the storage time of foods. Whether it’s dry goods in pantry storage or cold products in a refrigerator or freezer, the ideal conditions are out of direct sunlight. This helps control the temperature and prevent the food from degrading. Products with vitamins A, D, K and E, which are fat-soluble, can also break down in sunlight.
The humidity levels should stay lower than 15% to help preserve product quality. Moisture-proof packaging and air conditioning can maintain the appropriate levels. Keep a hygrometer in your storage areas to verify the humidity levels remain consistent. To protect food from contaminants and vermin, place shelves so food is at least six inches from the floor and walls, and one foot from the ceiling.

Storage Temperatures Are Key

Depending on what you store, temperatures may range from freezing to 140° F. Maintain dry storage temperatures between 50° and 70° F. Freezers must keep food frozen solid with an internal temperature of 0° F at most. Keep temperatures between 32° and 40° F in refrigeration units to prevent bacterial growth. Hot storage must keep food at a minimum of 140° F.

Temperature
Holding to temperature ranges are critical to prevent food poisoning. Photo courtesy Pixnio

These temperature ranges are critical to prevent food poisoning. Track temperatures and discard any food stored at the wrong temperature. Consider installing alarms tied to the thermometers in your storage units to alert your employees of critical temperature changes that could affect food safety and quality.

Store Based on Cooking Temperature

Did you know the temperature you must cook foods will determine which shelf you store them on in the refrigerator? The lower the finished temperature of cooked food, the higher a shelf you store it on. Ready-to-eat and cooked foods need to stay on the top shelf, wrapped tightly to prevent cross-contamination. Any ready-to-eat meats and cheeses go on the shelf below. Again, keep them tightly covered or wrapped.

Raw foods go on the bottom three shelves. The third shelf from the top should hold foods cooked to 145° F. including raw fish and shellfish. Below that shelf, keep raw pork, beef and veal. These include cuts and steaks but not ground meat. These have a cooked temperature of 155° F. The bottom shelf holds ground meat and whole eggs. These must cook to an internal temperature of 165° F.

Foods that need cooking thoroughly must stay in enclosed pans or on non-absorbent shelving. Use airtight containers where possible to store food. This protects the food from drying out, preserving its quality. Additionally, the food will stay free of contamination from other foods in the storage unit. This is especially important for refrigerated foods, which may still harbor liquids that can get onto other foods.

Label and Check Foods in Storage

While you should label unopened foods, it’s even more important to label opened foods. Use all foods before the type expires. For instance, summer sausage stays fresh for only three weeks after opening in the refrigerator, but it stays good up to three months unopened. If in doubt, throw the food out. It’s better to stay safe than sorry.

Prevent Cross Contamination During Cooking

During cooking, you can prevent contamination of fresh foods by raw foods through regular hygiene practices. All employees should thoroughly wash their hands with 110°-F water and soap. Despite hand washing, gloves must be worn at all times to protect consumers further.

Cutting boards
Never use the same cutting boards for raw meats and ready-to-eat foods. Photo courtesy PicJumbo.

When cooking, never use the same cutting boards for raw meats and ready-to-eat foods. Juice from undercooked meat could contaminate salad ingredients, sickening those who eat the salad. Also, use a cooking thermometer and always cook foods to the appropriate internal temperature based on the type of food. Reheat previously cooked dishes to an internal temperature of 165° F to stop bacteria growth.

When storing foods, place them in airtight containers that you can easily identify. This prevents things such as milk and cream from accidentally getting replaced with each other. It also ensures every item gets stored correctly. Correct labels on containers also help with preventing mix-ups.

Food Safety Starts With You

Food safety is critical to your restaurant’s operations. Improper storage can shut down your business from a food poisoning outbreak or a bad inspection from the local health inspector. Don’t let these happen to you. Follow these guidelines to ensure the food you store and serve remains safe and high-quality.

Mike Robach

The Future of Food Safety: A Q&A with Cargill’s Mike Robach

By Mahni Ghorashi
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Mike Robach

Continuing on our journey to bring you the successes, best practices, challenges and accomplishments from the very best in this industry, this month I had the pleasure of interviewing Mike Robach, vice president, corporate food safety, quality & regulatory for Cargill. Mike joined Cargill in January 2004 to lead the company’s corporate food safety and regulatory affairs programs. In this role, he helps partners innovate and manage risk so they can feel empowered to nourish the world

Mike Robach
Mike Robach, vice president, corporate food safety, quality & regulatory for Cargill

Mike has also worked closely with the USDA and FDA regarding food safety policy, HACCP, and regulatory reform based on science. He serves as chairman of the board of directors of the Global Food Safety Initiative (GFSI) and is a member of the Institute of Food Technologists and the International Association of Food Protection, among many other organizations dedicated to ensuring safe food and bringing innovative technology into the agricultural industry. He has worked with the World Organization of Animal Health (OIE) and the Food and Agriculture Organization (FAO) on harmonized animal health and food safety standards.

Mahni Ghorashi: What are the biggest risks to our food safety infrastructure in 2018? What’s keeping you up at night?

Mike Robach: The biggest risks I see have to do with supply chain integrity and how companies implement their systems. Too often we do not have line-of-sight to the origin of the commodities and ingredients that make up our products. With global supply networks it’s important to understand where and from whom you are getting your inputs. There is also a need for food safety capacity building throughout the global food system. Many small and medium companies, along with some large companies, do not have the proper training for their employees to manage a food safety program. We also have an issue with constantly changing regulations that are not uniform from country to country, adding risk to our business.

Ghorashi: What are you most excited about? What’s changing in a good way in the food safety sector?

Robach: I am very excited about the application of new technology to our food safety programs. In-line, real-time testing gives an opportunity to manage our processes and make immediate adjustments to assure process control. This allows us to prevent product that is out of control from reaching the marketplace. Blockchain technology gives us the chance to drive greater transparency throughout the supply chain.

Ghorashi: Let’s talk about regulation. How is the implementation of FSMA going? Do you foresee any challenges with the next phase of implementation?

Check out last month’s Q&A with Frank Yiannas of WalmartRobach: I think FSMA implementation is going okay right now. There’s still a long way to go, and I am always concerned about making sure investigators are applying the rules and regulations in a consistent manner. I see the intentional adulteration rule as an upcoming challenge. It is one thing to conduct a vulnerability assessment and adjust your programs based on the results. It’s another to develop and implement a program that will prevent intentional adulteration as you would to reduce or prevent microbiological contamination.

Ghorashi: If you take a look at the homepage of Food Safety News, all you see is recall after recall. Are transparency and technological advancement bringing more risks to light and are things generally trending towards improvement?

Robach: I believe that food safety management programs are constantly improving and that our food is as safe as it has ever been. However, we still have a lot of work to do. At GFSI, we are continually improving our benchmarking requirements and increasing transparency in the process. We have better public health reporting and our ever-improving analytical technology allows us to detect contaminants at lower and lower levels. The industry is working collaboratively to share best practices and promote harmonized food safety management systems throughout the supply chain.

Ghorashi: What is the number one challenge of securing global supply chains for 2018?

Robach: Knowing and understanding the integrated supply chain. Having knowledge and control of the process from origination to consumption would be ideal. We need the implementation of risk-based, harmonized food safety management systems based on the principles of Codex. Assuring the application of these systems along with properly trained employees to implement these programs would be the first step towards a secure, safe global food system.

Ghorashi: How do international trade deals and the stance of the current administration affect the future of food safety policy?

Robach: International trade deals such as the Trans Pacific Partnership and NAFTA can do a lot for the assurance of safe food around the world and within regions. Making sure that food safety provisions are included in these trade deals can drive the implementation of food safety management systems that will ensure safe food for consumers everywhere. These types of deals should allow us to remove technical barriers to trade by basing the requirements on Codex principles and adhering to the WTO SPS agreement.

Ghorashi: What role is blockchain technology playing in food safety? What are the prospects for the future?

Robach: Blockchain has a role to play in driving more transparency across the integrated supply chain. It can allow companies to show consumers where their food comes from. It can also be used to quickly trace back product in the event of a food safety problem. Still, it’s an enabling technology, not a solution.

Ghorashi: What about CRISPR? How is the food industry starting to respond to this technology from both a policy and GMO screening?

Robach: Gene editing holds great promise and many companies are looking at its potential benefits. However, there is always the policy question on whether or not the use of this type of technology should be labeled. I think the food industry has not done enough to promote the use of technology and how food production has improved over the years. We should let consumers know how we apply science to making food safer, more nutritious and more sustainable. At Cargill we have the vision of being the leader in nourishing the world in a safe, responsible and sustainable way.

Ghorashi: What trends are you seeing in food safety processes within food companies? Are they becoming more decentralized? Less? How are they balancing innovation with decades-old food safety practices?

Robach: Through the Global Food Safety Initiative, we have promoted harmonized, risk-based food safety management systems. The GFSI-benchmarked certification programs provide an opportunity for companies to implement consistent food safety programs regardless of where they are in the world. Through the GFSI Global Market Program there’s a tool kit that less sophisticated companies can use as a pathway towards full certification. We are constantly updating the benchmarking requirements to assure they are keeping up with changing science and technology.

X-ray systems

Production and Inspection: What to Do When Contamination Occurs

By Chris Keith
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X-ray systems

As much as food manufacturers take precautions to avoid all types of contaminants, there can still come a moment when you realize that your best efforts have failed. Maybe you find a broken blade or a missing wire during a sanitation break, but the product has already gone through your inline inspection machines—and nothing was detected.

This is the freak-out moment that no plant manager or quality assurance manager wants to have. Knowing that there’s possible contamination of your food product (and not knowing where that contaminant might be) creates a hailstorm of possibilities that your plant works hard to avoid. And you’re probably wondering how this could have happened in the first place.

X-ray systems
In addition to metal, X-ray systems can find glass, plastic, stone, bone, rubber/gasket material, product clumps, container defects, wood and missing components at 0.8 mm or smaller.

Understanding How Contaminants Get Past Detection

To prevent physical contamination from occurring, it’s important to understand the reasons why it happens. In-house inspection systems often fail to detect contaminants for the following reasons:

  • The equipment isn’t calibrated to detect contaminants to a small enough degree, or the contaminants are materials that aren’t easily detected by the in-house machinery (glass, rubber, plastic, etc.)
  • The machines aren’t constantly monitored
  • The speed of the production line doesn’t allow for detecting small particles

Metal detectors are the most commonly used inline inspection devices in food manufacturing, and they depend on an interference in the signal to indicate there is metal contamination in the product.
Despite the fact that technology has progressed to deliver fewer false positives, the machines can still be deceived by moisture, high salt contents and dense products that could provide interference in the signal. When that continues to occur, it’s common for manufacturers to recalibrate the machine to get fewer false positives—but that also decreases its effectiveness.

Another limitation of the metal detector is that, as the name indicates, it can only find metal. That means contaminants like plastic, glass, rubber and bone won’t be found through a metal detector, but will hopefully be discovered through some other means before the product is shipped out.

Oftentimes, contamination or suspected physical contamination is discovered when a product, such as cheese or yogurt, goes through a filtration system, or when a piece of machinery is inspected during a sanitation break.
If the machinery is found to be missing a part, such as a bolt or a rubber gasket, the manufacturer then has to backtrack to the machinery’s last inspection and determine how much, if any, of the product manufactured during that time has been contaminated.

X-ray inspection
X-ray inspection can find what other forms of inspection cannot, because it’s based on the density of the product, as well as the density of the physical contaminant. In this image, you can see foreign material detected in canned goods.

What To Do When Contamination Occurs

Once a food manufacturer discovers that it may have a physical contamination problem, it must make a decision on how to handle the situation. Options come down to four basic choices, each of which comes with its own risks and benefits.

Option 1: Dispose of the full production run

The one advantage of disposing of a full production run is that it entirely eliminates the possibility of the contaminated product reaching consumers.

However, this is an expensive solution, as the manufacturer has to pay for the cost of disposal in a certified landfill and absorbs the cost of packaging, labor and ingredients. It also presents the risk of lost revenue by having a product temporarily out of stock.

Option 2: Shut down your production lines for re-inspection/re-work

Running the product through inline inspections a second time may result in finding the physical contaminant, but there’s also a risk that the contaminant won’t be found—and now the company has lost money through overtime pay and lost productivity.

If the inspection equipment was not sensitive enough to find the contaminant the first time around, it may not find it the second time, which puts the manufacturer back at square one. The advantage to this method is that the manufacturer maintains complete accountability and control over the process, although it may not yield the desired results.

Option 3: Risk it and ship the product to retailers

There’s always a chance that a missing bolt didn’t make its way into the product. Sometimes, if a metal detector goes off and the manufacturer can’t find any contaminants upon closer examination, they will choose to ship the product and take their chances.

The advantage for them is that, on the front end, this is the least expensive option—or it could be the costliest choice of all if a consumer finds a physical contaminant in their food. In fact, the average cost of a food recall is estimated at $10 million; lawsuits may push that cost even higher and result in a business being closed for good.

Option 4: Use third-party X-ray inspection

X-ray inspection is the most effective way to find physical contaminants. In addition to metal, X-ray systems can find glass, plastic, stone, bone, rubber/gasket material, product clumps, container defects, wood and missing components at 0.8 mm or smaller.

When a food manufacturer has a contamination issue, it can have the bracketed product inspected by a third-party X-ray inspection company and only dispose the affected food, allowing the rest of the product to be distributed. This option allows the manufacturer to maintain inventory and keep food deliveries on schedule while still eliminating the problem of contamination.

X-ray inspection can find what other forms of inspection cannot, because it’s based on the density of the product, as well as the density of the physical contaminant. When X-ray beams are directed through a food product, the rays lose some of their energy, but will lose even more energy in areas that have a physical contaminant. So when those images are interpreted on a monitor, the areas that have a physical contaminant in them will show up as a darker shade of gray.
This allows the workers monitoring machines to immediately identify any foreign particles that are in the food, regardless of the type of material.

Detection is Key to Avoiding Contamination Issues

Handling contamination properly is vital to every food manufacturing company. It affects the bottom line and the future of the company, and just one case of a physical contaminant reaching the consumer is enough to sideline food companies of any size. As X-ray technology continues to evolve, it remains an effective and efficient form of food inspection.

Educating plant managers and quality managers on what to do if inline inspection machines fail to detect contaminants should include information on how X-ray technology can be a food company’s first line of defense. While physical contaminants can’t always be avoided, they can be detected—and the future of your company may depend on it.

Frank Yiannas, Walmart

The Future of Food Safety: A Q&A with Walmart’s Frank Yiannas

By Mahni Ghorashi
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Frank Yiannas, Walmart

Continuing on our journey to bring you the successes, best practices, challenges and accomplishments from the very best in this industry, this month I had the pleasure of interviewing Frank Yiannas, vice president of food safety at Walmart. In his role, Frank oversees all food safety, as well as other public health functions, for the world’s largest food retailer, serving more than 200 million customers around the world on a weekly basis.

Frank is a past president of the International Association for Food Protection (IAFP) and a past vice-chair of GFSI. He is also an adjunct professor in the Food Safety Program at Michigan State University, and in 2017 was awarded the MSU Outstanding Faculty Award. He’s also the author of two books, Food Safety Culture, Creating a Behavior-based Food Safety Management System, and Food Safety = Behavior, 30 Proven Techniques to Enhance Employee Compliance.

Mahni Ghorashi: What are you most excited about in our industry? What’s changing in a good way in the food safety sector?

Frank Yiannas, Walmart
Frank Yiannas, vice president of food safety, Walmart

Frank Yiannas: While there is no doubt that there are numerous new and emerging challenges in food safety, the many advancements being made should give us hope that we can create a safer, more efficient, and sustainable food system.

There is progress being made on many fronts: Whole genome sequencing is becoming more accessible; new tools are being developed for fraud detection; and FSMA is introducing stringent public-health surveillance measures that have dramatic implications for U.S. retailers and suppliers and our import partners.

Most importantly, consumers are now overwhelmingly interested in transparency. People today are further removed from how food is grown, produced and transported than at any other time in human history. Plus, they increasingly mistrust food and food companies due to the food outbreaks and scares we have faced in recent years.

Over the near-term, as we get better at detecting foodborne outbreaks, consumer mistrust will likely intensify; however, it’s clear to me that heightened consumer interest is hugely positive because it adds weight to our industry’s call for more accurate food labeling, more wholesome ingredients and enhanced food traceability. Ultimately, these are the kinds of measures that will improve the food system and enhance consumer trust.

Ghorashi: As you know, food shopping is moving online. It’s happening across the world, and at breakneck speed. What are retailers like Walmart doing to keep up?

Yiannas: That’s a great question. Walmart and other retailers are now developing new packaging materials and temperature control approaches, as well as new ordering methods, high-tech stocking systems and delivery modes.

Food shopping is moving online so quickly that regulatory requirements have not been able to keep up. That means it’s up to us, the retailers and food companies, to work with regulators to create and promote the necessary industry standards, best practices and logistical solutions.

I firmly believe that it is our responsibility as food retailers to advocate for consumers and strive to create a safer and more affordable and sustainable food system. With many more players across the global food chain now shouldering this duty of care, I am very optimistic that our industry is truly improving the lives of people around the world.

Ghorashi: What role is blockchain technology playing in food safety? What are the prospects for the future?

Yiannas: The emergence of blockchain technology and the successful completion of several pilots using it to enhance food traceability has resulted in a larger conversation about the importance of creating a more transparent digital food system.

It has also enabled food system stakeholders to imagine being able to have full end-to-end traceability at the speed of thought. The ongoing U.S.-wide romaine lettuce E.coli outbreak showed us, once again, that our traditional paper-based food tracking system is no longer adequate for the 21st century. An ability to deliver accurate, real-time information about food, how it’s produced, and how it flows from farm to table is a game-changer for food safety.

Blockchain has the potential to shine a light on all actors in the food system. This enhanced transparency will result in greater accountability, and greater accountability will cause the food system to self-regulate and comply with the safe and sustainable practices that we all desire.

Food Fraud

Food Fraud Requires Companies to Think Like a Criminal

By Juliani Kitakawa, Veronica Ramos
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Food Fraud

In a two-question format, the authors discuss pressing issues in food fraud.

1. Where are the current hot spots for food fraud?

Food fraud activities have been known for centuries. For example, in ancient Rome and Athens, there were rules regarding the adulteration of wines with flavors and colors. In mid-13th century England, there were guidelines prescribing a certain size and weight for each type of bread, as well as required ingredients and how much it should cost. In the United States, back in 1906, Congress passed both the Meat Inspection Act and the original Food and Drugs Act, prohibiting the manufacture and interstate shipment of adulterated and misbranded foods and drugs. However, evidence and records of actions taken over those events were not officially collected.

It was not until 1985, when the presence of diethylene glycol (DEG) was identified in white wines from Austria, that authorities, retailers and consumers started to have serious concerns about the adulteration of food and the severity of its impact on consumers. In addition, there was increased interest to regulate, investigate and apply efforts to enforce requirements.

Other examples include the following:

  • 2005: Chili powder adulterated with Sudan (India)
  • 2008: Dairy products adulterated with melamine (China)
  • 2013: Beef substituted with horsemeat (UK)
  • 2013: Manuka honey where it was known that bees were not feeding from pollen of the Manuka bush (New Zealand)
  • 2016: Dried oregano adulterated with other dried plants (Australia)

This list can go on and on.

Lately there have been more cases of food fraud. Fortunately, even limited international databases are helping to identify the raw material origins of products in the supply chain that could be more exposed to adulteration. Also, food manufacturers, brokers and agents are conducting assessments to ensure that they are buying ingredients and products from sources, where food fraud could be prevented. The following products are identified as having more adulteration notifications:

  • Olive oil
  • Fish
  • Vegetable products with claims of “Organic”
  • Milk
  • Grains
  • Honey and maple syrup
  • Coffee and tea
  • Spices
  • Wine
  • Fruit Juices

2. What can companies do to mitigate the risk?

Control measures to prevent food fraud activities include the adequate evaluation and selection of suppliers, as well as the ‘suppliers of the suppliers’. Typical risk matrices of likelihood of occurrence versus consequence can be used to measure risk—and determine priorities for assessing and putting control measures in place. Assessments can be focused on points of vulnerabilities such as food substitution, mislabeling, adulterations and/or counterfeiting, usually due to economic advantages for one or more tiers in food chain production.

Other food fraud activities include effective traceability systems, monitoring current worldwide news and notifications on food fraud using international databases (EU-RASFF, USA- EMA NCFPD and USP, etc.), and product testing.

Product testing is becoming an important tool for the food industry to become confident in sourcing raw materials, ensuring the management of food fraud control measures, fulfilling applicable legal requirements, and ensuring the safety of consumers.

Product testing laboratories offer different kinds of testing methods depending on the required output; for example, if it is possible and requested, a targeted or non-targeted result.

Targeted analysis involves screening for pre-defined components in a sample:

  • Liquid chromatography
  • Gas chromatography
  • Mass spectrometry (LC-MS and GC-MS)
  • Nuclear magnetic resonance spectroscopy (NMR).
  • PCR technique

Non-targeted analysis aims to see any chemical present in the sample:

  • Isotopic measurement-determination of whether ethanol and vinegar and flavorings are natural or synthetic
  • Metabolomics: Maturation and shelf life
  • Proteomics: Testing for pork and beef additives in chicken, confectionery and desserts

Due to the importance of food fraud for a food safety management system, GFSI published Version 7.1 of Benchmarking Requirements, including subjects on food fraud, as vulnerability assessment. In 2018 all certification schemes have incorporated such requirements and started enforcing them.

Fraud cases threat consumer trust in products and services. Companies are learning to “think like a criminal” and put in place measures to prevent fraud and protect their products, their brands and their consumers.

Compliance, food safety

Leveraging FSVP Compliance: Do Less, Get More

By Benjamin England, Nicole Trimmer
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Compliance, food safety

With an ever-expanding international food trade and new government demands for food safety and supply chain transparency, the U.S. regulatory landscape is becoming increasingly more complex. FSMA (especially the Foreign Supplier Verification Program) aims to shift responsibilities for imported food safety from FDA to importers in an effort to reduce the regulatory burden on FDA. New regulations bring new burdens to food trade stakeholders, requiring significant investment. However, many of the data obligations of the FSVP rule dovetail with other agencies’ requirements.

Investments in one dataset can be leveraged to improve a company’s overall compliance related to international trade. The key is to integrate FSVP requirements into a strong regulatory compliance program without breaking the bank. This requires identifying data overlap, utilizing compliance integration to work smarter, not harder, leveraging the window of opportunity to collect more (and necessary) data from your foreign suppliers, and calling in the right help when needed.

TRUST…..BUT VERIFY: 2018 FSMA Focuses on Supplier Verification Activities | Learn more at the Food Safety Supply Chain Conference | June 12–13, 2018 | Rockville, MDToday’s International Supply Web

No longer can we reasonably talk about establishing, monitoring and maintaining a supply “chain” when importing anything. International trade in food and its ingredients is rarely bilateral—except for perhaps fresh produce, meat and seafood. Instead, food moves throughout a complex supply web of international transactions. Most processed food now contains ingredients from multiple countries, leading to food safety verification challenges and country of origin questions for finished goods.

The international supply web includes farms (land and aquaculture), agriculture cooperatives, food grade chemicals manufacturers, color and flavoring formulators and manufacturers, raw materials processors and fabricators, finished food processors & packers, warehouses, transportation companies, cooking, canning and irradiating facilities, shippers, exporters, product and commodities brokers, importers, wholesalers, retailers and e-tailers. Any (or all) of these players may be small operations located in different countries or multi-national conglomerates operating on several continents. There is very little food consumed in the United States that is not affected, in some way or another, by international commerce and trade.

Shift to a Preventive System

In 2011, Congress passed FSMA with the goal of moving U.S. food safety from a reactive to a preventive system, and integrating HACCP-like principles into the production of all food. Over the ensuing years, FDA issued seven major regulations that address various facets of food safety.

The Foreign Supplier Verification Program (FSVP) rule was included as a way to ensure that foods imported into the United States are produced in a manner that meets U.S. safety standards. FSVP requires that “importers,” which can be the distributors or retailers of products, verify and document the steps taken to ensure safe production of animal and human food. While the exact FSVP requirements vary depending on the commodity, the FSVP process often includes developing, maintaining and documenting a food safety plan and, as its name suggests, verifying that foreign suppliers are controlling for appropriate hazards. Developing and implementing these plans requires a wide variety of skills, including hazard analysis and risk assessment, establishing preventive controls, developing recall plans, and careful documentation of the process. FSVP also requires that verification activities be carried out by parties who have specific preventive control training, or “PCQIs” (Preventive Control Qualified Individuals).

Most importantly, FSMA and the FSVP rule shift the burden of safety from FDA to the importer. With increased interconnectedness, flaws in food safety documentation can become magnified throughout the system. Note that FSVP covers food safety only—not necessarily food traceability or food security defense—although there are opportunities for crossover ROIs. To achieve FSVP compliance, you need to know who is handling your food before it is imported, what they know about food safety, and how they apply food safety principles.

Cross-agency Data Usage

Approaching FSVP as a stand-alone regulatory compliance initiative is expensive and inefficient. Many activities and data elements that must be kept for other government agencies and their compliance programs should be linked together. The data your foreign suppliers must provide to international carriers for advanced notice to U.S. Customs and Border Protection (“CBP” or “Customs”) by importing carriers (airlines, trucking companies and vessel operators) is relevant to both Customs entry and FDA food safety compliance and documentation. This overlap presents an ideal opportunity to relieve the burden of the new FSVP requirements and kill two birds with one stone. And the overlap and leveraging opportunities are actually quite substantial—if one knows where and how to look for them.

For example, the USDA’s National Organic Program (NOP) regulations specify requirements for the processing, handling and labeling of raw materials and processed goods to meet organic standards. Organic labeling and marketing claims are affirmative assertions that the labeled food has not been exposed to processing steps, processing chemicals or particular substances (e.g., sewage sludge, ionizing radiation) that would cause it to fall out of the regulatory bounds of an organic food product. Where organic processing and handling crosses over to food safety, leveraging organic compliance documentation buttresses the safety of the resulting food—and the importer’s FSVP program.

Additionally, much of the information that the importer must know to properly classify their product under the Harmonized Tariff Schedule (HTS) is the same information that the importer needs for their FSVP plan; the importer must know the products, what they are made from, how they are processed, and how they are intended to be used to both properly classify and verify the safety of their product. Because FDA requires the importer to verify that its foreign supplier has a system that meets the domestic food safety standards, the foreign supplier must also be able to identify its own ingredient and raw material suppliers and their systems for food safety, as applicable. Therefore, the food importer’s FSVP process promotes documentation compliance with CBP’s and other government agencies’ requirements governing the country of origin of materials for applicability of preferential duty rates (e.g., under a free trade agreement) and country of origin labeling.

Another example of data overlap is the FSVP requirement for supplier verification and the responsibility to show correct valuation of your product for Customs. FSVP requires that you verify your suppliers and ensure your product is genuine, and Customs requires that you declare an appropriate valuation and identity for your shipment. If Customs investigates your shipment and determines your valuation is incorrect, it may trigger the Department of Commerce to investigate whether there are anti-dumping and countervailing issues going on with the product.

Issues with anti-dumping and countervailing duties are extremely time-consuming and expensive. In both 2008 and 2016, federal authorities investigated rumors of companies circumventing anti-dumping duties by transshipping food products through third countries (to conceal actual origin of the material). When Customs investigated a honey processing plant, they found evidence that the purported processor of Vietnamese honey was receiving finished product from China and relabeling it as originating from Vietnam. When importers declared imported Vietnamese honey, Customs determined from trace mineral testing that the honey was, as they suspected, Chinese. Customs seized the product. The lesson to learn from this is to know your suppliers and the actual supply web. In the case of country of origin violations, not verifying the country of origin can be costly. Where CBP finds negligence is involved, the agency can look back five years to recoup lost duty plus interest, and can even reopen old liquidated entries and assess monetary penalties. In completing your FSVP plan, requesting documentation demonstrating origin is a small additional step that furthers the strength of CBP-required documentation to support the origin declaration at entry. That’s leveraging.

Document, Document, Document

Under the Customs Modernization Act of 1993, the compliance watch-words for all importers (and customshouse brokers) are “record keeping,” “shared responsibility,” “reporting,” and “due diligence.” Anything that is required for a proper importation is subject to CBP review and audit—whether the requirement arises as supply chain and source data under the Seafood Import Monitoring Program (SIMP) under the National Marine Fisheries Service (NMFS), or organic labeling and compliance under USDA’s NOP regulations, or speciation documentation under the Lacey Act enforced by U.S. Fish and Wildlife (USFW), or FSVP implemented by FDA. Therefore, the engagement between food importer and foreign food supplier forced by FSVP opens the opportunity for the importer to clarify and shore up its documentation obligations for many other coexisting regulatory regimes.

A clear demonstration of this fact is borne out by the regular process that ensues when CBP issues to an importer of record a Customs Form 28 (or “CF28”). The CF28 is a CBP request for additional information relating to an imported shipment. The importer is usually required to respond within 30 days of its issuance. But ordinarily the CF28 is issued months (and sometimes years) after the importation occurred. Therefore, the CF28 process represents a significant challenge to the importer’s record keeping and compliance documentation systems, and legal liability to the importer’s bottom line.
Documents needed to respond adequately to a CF28 include contracts, purchase orders, packing lists, shipping documents, declarations to government authorities throughout the import process, powers of attorney, country of origin certifications, emails and other communications discussing any of these documents. CBP requests these documents to confirm the proper electronic data was submitted with the importation. And, of course, CBP is checking to see if the importer is attempting to circumvent U.S. import or export laws that may deprive the government of revenue.

The identity and location of an importer’s trading partners (including the foreign supplier and its suppliers), contracts between and among them (e.g., related to description, processing methods, equipment used, quality and condition of goods), origin documentation, proofs of packing and shipping, etc., are all subject to production via the CF28 process. Penalties for errors in the documentation that result in a regulatory or administrative action are imposed upon the importer (for failing to document or exercise due diligence in performing its function as an importer under U.S. law).

The FSVP regulation presents an ideal opportunity for the importer to establish and populate a compliance program that integrates its FDA import regulatory obligations with those of CBP and other regulatory agencies, as applicable. Failing to take this rare opportunity—at a time when foreign suppliers are expecting probing questions from their U.S. trading partners—is a mistake.

Because the government is more connected, it is essential to change how you prepare for and respond to issues that arise. Just as the FDA’s FSVP rule aims to move food safety from a reactionary to preventive system, coordinated proactive compliance with all government agency requirements will be necessary for the future. Further, with new regulations, your customs broker may not be equipped to deal with certain areas or when administrative matters escalate. But how do you prepare for any eventuality when the enforcement possibilities seem endless?

When preparing your FSVP plans, reviewing your Customs documentation, and reviewing other government agency requirements, it is critical that you think through all the potential issues that may arise with your product or its supply chain, and address them proactively in your documentation. What might an inspector or compliance officer think about the information provided? Is it thorough, clear, and logical? Does it tell a consistent narrative? What if another agency sees this information? Will they have further questions? The ultimate goal is accurate and thorough data for submissions to FDA, Customs and any other partner government agencies.

Key Steps to Prepare for the Worst-case Scenario

Lastly, let’s not forget that part of being prepared is preparing for the worst-case scenario. What happens when you are confronted by an issue? We recommend taking four key steps. First, marshal your resources (documents, documents). Second, ask, “Who are the key players in the story (e.g., which agencies are involved or could possibly be involved, and what are they requesting)?” The third question, a bit less straightforward, is, “How must I respond? (e.g., is the agency within its regulatory authority and required time constraints; are there conflicts of interest; what is the potential legal exposure to risk for different actions)?” Finally, do a gut check: Are the examinations subjective in nature or qualitative (rather than quantitative)? Is any required testing appropriate for the product? If you feel you cannot confidently answer these questions using current staff, we recommend you prepare for import issues by selecting professionals who have experience with integrated agency regulations and legal compliance requirements. The keys to expediting the process when working with multiple government regulatory agencies are integrating your compliance to ensure you have a true green-means-go light before you ship and being able to present a clear and consistent regulatory narrative to all agencies. This requires a clear understanding of how the government regulatory requirements actually intersect.

Three Ways Sanitation Automation Helps Food Processors Reduce Costs

By Bob Ogren
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Sanitation in a food processing plant is a large-scale effort that many organizations see as an added cost of doing business. Yet, it’s essential and can have costly consequences if done improperly.

Because time is money and facilities want to avoid any necessary downtime, the window for completing proper sanitation procedures is small. Many food processors simply put more people on the job while requiring them to work third shift, hoping to get things done faster.

Automating certain sanitation procedures in your plant can provide real benefits, many of which will help reduce the costs associated with food safety and keeping your facility clean. Here’s a look at the three main ways food plants can save by implementing automated sanitation solutions.

1. Resource Management

When you invest in sanitation automation, one of the biggest advantages is the increased understanding of how resources are being used. This knowledge and improved visibility gives you control of how resources such as water and chemicals are used during sanitation.

Butcher cleaning the floor at meat factory. Image courtesy of Birko.

Perhaps the most significant area in which facilities experience savings is through reduction of water usage. Automated solutions improve the efficiency of rinse cycles while ensuring appropriate water pressure is being used. Every plant has unique water needs, but you should expect water savings between 30% and 50%, depending on the solutions that are applied.

Sanitation automation will also lead to a reduction in energy costs. Using less water means less energy is required to heat that water. Advancements in sanitation technology have made certain solutions more energy efficient. Features such as multi-stage pumps for full alternation, motors that allow pumps to ramp up and down as needed, and flow switches that send pumps into “hibernate” mode help reduce electricity usage.

Waste water from food processing also needs to be treated before it goes down the drain. Less water treatment means fewer chemicals are needed.

Food processors that introduce automated sanitation solutions will use cleaning chemicals more efficiently. Automation ensures chemicals are dispensed precisely where they are needed at the correct concentration, without any over spray. Again, while every situation is unique, most facilities can expect a 20–30% reduction in chemistry costs.

In the end, you will have a very clear picture of the amount of water and chemistry needed to complete sanitation, and you’ll know the amount of time it should take. That means you can plan for more uptime.

Overall, not only can automation help food processors make efficient use of resources, it also makes them more sustainable.

2. Labor Costs

Labor is yet another resource that can be more effectively managed when there’s an investment in sanitation automation. The labor market is tight, and it is becoming increasingly difficult to hire the people needed to carry out sanitation work.

Sanitation often involves menial and tedious tasks that also require attention to detail. It usually entails working overnight when production stops, and certain responsibilities can be dangerous. At the same time, minimum wage is rising, and many organizations are looking to reduce labor costs.

Introducing sanitation automation can certainly cut labor expenses and remove the need to hire more people, but more importantly, it can make the workers you do have more productive. Automation should be used to eliminate menial tasks from sanitation workers. For example, instead of a person standing in front of a conveyor belt and spraying it down with a hose for hours on end, the job could be easily automated.

We worked with a brewer who was having two employees take as long as three hours to clean a filler. By automating that task, they turned it into a 45-minute job and allowed those employees to refocus their efforts. Plus, the before and after pictures of the equipment show a visible difference in cleanliness.

You can trust an automation solution to do a consistent job, and it will never call in sick.
Still, you’ll always need to have “boots on the ground” and human eyes evaluating sanitation. Automating certain sanitation practices will free up employees to work on more important duties that add value and keep them engaged in their work.

3. Mitigating Safety Risks

The most important thing sanitation automation provides is more peace of mind. No one wants to lose sleep worrying about a failed inspection or the potential for a worker injury. Automation reduces the risk of product contamination and lessens potentially dangerous situations for employees.

For instance, spiral freezers are particularly precarious areas to clean. Automating its cleaning process eliminates the need for a worker to maneuver through an unsafe space, reducing the likelihood of a workplace injury.

Human labor can also lead to human error. But, when sanitation tasks are automated, they become more consistent and easily repeatable. This is especially important for cleaning hard-to-reach problem spots that become harborage areas for bacteria. There may be a tendency among human workers to skip areas they can’t reach, or fail to clean them properly, but a machine cleans everything the same every time.

The monetary risk of contamination inside your facility is significant. For example, if Listeria were to take up residence in a plant, it could cost your business millions of dollars.

According to a study from the Food Marketing Institute and Grocery Manufacturers Association, the average food product recall will have direct costs of $10 million while indirect costs could reach into the hundreds of millions. That’s because you also need to consider the ongoing cost of a damaged brand reputation, not to mention lost productivity from business interruptions and lost profits from disposing of potentially contaminated product.

Sanitation Automation: The Future is Now

There are many reasons to start implementing automation into your food and beverage plant’s sanitation practices. Food processors in Europe have been quicker to adopt these solutions because many of the same issues U.S. manufacturers face, such as wages and resource scarcity, can be even more pronounced overseas.

As the labor market in the United States presents challenges for hiring managers, and drought conditions in some regions make water a scarce commodity, automation presents an opportunity to bring your facility into the future. Add to those concerns the increased regulations from FSMA, and there is even more reason to invest in dependable sanitation solutions.

Food processors need to find trusted advisors who can evaluate operations inside the plant and look for ways to implement automation in ways that make the largest impact.

While there is certainly an upfront cost in automating sanitation, the potential savings and added visibility these solutions provide won’t take long to pay for themselves. In most cases, facilities that invest in sanitation automation will see a return within a year to 18 months. If done properly, you can achieve impressive cost-saving results through automation.

Omar A. Oyarzabal, Ph.D.

Unraveling the Impact of FSMA On Acidified Food Regulations

By Omar A. Oyarzabal, Ph.D.
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Omar A. Oyarzabal, Ph.D.

The world of acidified foods is complicated—the question of how an acidified food is distinguished from an acid food, how to measure pH of acidified foods that are not homogeneous, what kinds and how records should be maintained and finally, how FDA enforces requirements? As consultants to FDA regulated industries, we receive numerous questions, as does FDA directly, on acid and acidified foods. This Q&A, answered by EAS Independent Consultant, Omar Oyarzabal offers insight into commonly received questions and their answers.

Q: How you distinguish an acid food from an acidified food?

Omar Oyarzabal: Acid ingredients have a natural pH of 4.6 or below, while low acid ingredients have a natural pH above 4.6. Acidified foods are comprised of low acid ingredients mixed with acid ingredient or acid to bring the finished product equilibrium pH to less than 4.6. Remember, all pH meters have a normal variation in the measurements, and therefore that variation must be understood and accounted for when measuring the equilibrium pH. For instance, if you measure a pH of 4.3, and may have a ± 0.02, the actual pH is between 4.28 and 4.32. If the variation is ± 0.05, the actual pH may be between 4.35 and 4.25. We would like to see some room for safety and therefore the highest target equilibrium pH is, in many cases, 4.4. The finished equilibrium pH is the pH of all components of the product. It can happen quickly after mixing and final preparation, or it may take hours or days.

Note: pH meters perform potentiometric measurements, meaning that the electrode measures a potential of [H+] or [OH-] in the test solution by comparison against known [H+] or [OH-] standard buffers. The numerical numbers produced by a pH meter are calculated following a scale. Therefore, we need to verify that the calculated pH scale is reliable by proper and regular calibrations.

Total Cases Reported for Previous Years
Botulism Cum 2017 Five-year weekly average  2016  2015  2014  2013  2012
Total 79  4  201 195 161 152 168
Foodborne 5  0  31 37 15 4 27
Infant 71  3  144 138 127 136 123
Other (wound and unspecified) 3  0  26 20 19 12 18
Table I. The main biological hazard of concern in acidified foods continues to be Clostridium botulinum. The latest Notifiable Diseases and Mortality Table was released by the CDC on January 5, 2018. Cases of botulism reported in the United States (Week ending December 23, 2017).

Q: Is there a formal procedure for assessing initial/raw pH? Specifically, should pH be immediately measured or should the system be given time to come to equilibrium?

Oyarzabal: There are two important pH measurements, the raw pH and the equilibrium pH. The raw pH is the pH of all the low acid food ingredients without the addition of the acid ingredients or acid to bring the finished product equilibrium pH to below 4.6. The equilibrium pH is tested in finished product after the pH has “equilibrated” and all particles and components of the finished product have the same pH. It is customary to measure the equilibrium pH after 24 hours of manufacturing, but the actual time depends on the products. If the product has particles with high buffer capacity, the product may take more than 24 hours to achieve an equilibrium pH. The shift from raw pH to equilibrium pH is called the “pH shift”.

Q: What is the basis for the 10% rule for non-acid ingredients, and is it acceptable to have more than 10% but still have acceptable shift in pH?

Oyarzabal: There is no regulation requiring less than 10%. It is a rule of thumb based on experience that has been used for some acidified products over the years. It is not part of any regulation per-se. The actual amount of acidification in a formulation is something for a process authority to evaluate and make a final recommendation.

Q: A challenge study is generally requested for an acidified food filing, however, the detail for the challenge study is not specified. Previously the three main pathogens were suggested for evaluation (pathogenic E. coli O157:H7, Salmonella and Listeria monocytogenes) and a 5-log reduction as criteria. What are current requirements?

Oyarzabal: A challenge study may be needed when developing a new product. But the microorganism of public health concern and/or spoilage concern will depend on the type of product (ingredient formulation) and process. New product should be treated on a cases-by-case basis and a processing authority should make recommendations.

Q: What is the focus of the FDA inspections of acidified foods? What are the agency recommendations for processors?

Oyarzabal: FDA has stated in the Preamble to the final Preventive Controls for Human Foods (PCHF) regulation that acidified foods would not be exempt from 21 CFR 117, Subparts C (specific preventive control requirements) and G (supplier management). Essentially, an acidified food manufacturer, during an FDA inspection, will be have to demonstrate compliance with both 21 CFR 114 (acified foods) and 21 CFR 117 (all foods). During any given FDA inspection, the FDA investigator may focus their attention on just part of the acidified food operation and the applicable regulations or on the entire acidified food operations and all applicable regulations. It is dependent upon the individual FDA investigator, the circumstances triggering the investigation, any recent illness outbreaks or deaths associated with a similar acidified foods, written FDA headquarters programs on acidified foods, etc.

Q: Is a continuous recording method required to prove compliance in meeting Critical Control Points at all times or is periodic manual check acceptable?

Oyarzabal: From a preventive controls perspective, there is no requirement for continuous monitoring. Monitoring has to be performed frequently enough to make sure there is “demonstrated” control of the hazard(s) addressed at that process or step. It may come down to what equipment is in place. But at the end of the day, the preventive control regulation provides flexibility for frequency, so long as it is appropriate to control the identified hazard. If a firm has justification that monitoring at a certain frequency is sufficient to control a hazard, it would be helpful to provide that justification if the issue came up during an inspection. Justification should be emphasized for the frequency of monitoring and verification, and must be robust enough to guarantee safety.

Q: Are salad dressings exempt from the acidified food regulations? What about cold brew coffee?

Oyarzabal: Most salad dressings may be exempt, but it would be wise for any salad dressing manufacturer to ensure that they are using a processing authority with expertise in the type of product to conduct a food safety evaluation and put their recommendations in writing, just in case there is a challenge by FDA, a customer or competitor.

All the cold brew coffees we are aware of are sold under refrigeration and therefore are exempt from low acid or acidified food product regulations.

Note: Most states have individuals that will help the industry identify the laws covering their products. The FDA also has a portal for submission of industry request related to food safety regulations that may apply to specific products.

Q: I want to produce a cold-fill beverage that will have preservatives in the recipe, do I still require a process authority to create a process schedule?

Oyarzabal: You need to have someone to review the product formulation and the process to see if it is a low-acid or acidified food, and determine the food safety regulation under which the product falls. It may be exempt from some regulations, but someone with the appropriate knowledge, such as an FDA recognized “Process Authority”, needs to make that determination. The FDA also has a portal for submission of industry questions related to food safety regulations that may provide a more direct answer to this question.

Q: What are FDA’s expectations on cold-filled acidified foods? Do we need to hold the products till the product formulation ensures 5-log reduction of relevant pathogens?

Oyarzabal: This is a product-related question and without the full understanding of the formulation and process, it is hard to provide any recommendation. The cold-filled process can be managed for acidified foods in a manner that would maintain the safety of the food and not impact the pH requirements or result in recontamination.

Q: Does FDA consider “water” ingredient as a “low-acid” ingredient? What about under the FSMA Rule?

Oyarzabal: Yes, traditionally water has been considered a low acid ingredient as it has the ability to modify the pH of the food. In some recipes water is added in such a low amount that it doesn’t change the rest of the formulation. The addition of water in those cases doesn’t change the rest.

Q: Are inspectors using the Acidified Guidance Document that was pulled a couple of years ago for inspections?

Oyarzabal: The 2010 draft received lots of comments, and ultimately was never finalized from draft form. Investigators inspecting acidified foods are aware of the 2010 guidance, but they should not be enforcing the provisions in this draft guidance. A guidance document is not binding on FDA or industry, but provides recommendations to consider as it contains the agency’s thinking at a given time in relation to a given piece of regulation. That being said, based on observations and comments from the acidified food manufacturing industry, FDA investigators are using the draft guidance as a reference source.

Q: Are electronic records permitted for process controls (e.g., electronic record of temperature instead of chart recorders)?

Oyarzabal: Yes. The Preventive Controls rule speaks to the acceptability, in theory, of electronic records, though, as stated in 117.305(g) they are not required comply with 21 CFR 11 (Electronic Records; Electronic Signatures). These along with any other records should be accessible and retrievable as appropriate in a reasonable time frame for review by an FDA investigatory.