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.

Heather Madland, Huron Capital

Accelerating Growth Through Acquisition

By Heather Madland
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Heather Madland, Huron Capital

Developing a plan for meaningful growth can be a challenge many business owners face. With Gross Domestic Product growth currently at three percent, if you aren’t launching new products or services, adding new customers, or increasing sales to existing customers, the road to continued growth may not be clear. However, a careful and strategic purchase of a company – an acquisition – is one approach that could help you in meeting your company’s growth goals in less time with potentially less uncertainty than relying on only organic growth to get you there.

The advantages of acquisition

While acquisition may come at a significantly higher cost than certain organic growth initiatives like expanding your manufacturing facility or solidifying a new customer relationship, it’s potentially faster to execute. Of course, no substantial business move is without its risk, acquisitions included, but an effective acquisition strategy can be worth considering particularly for a small or middle market company looking to accelerate revenue and earnings. Advantages may include:

  • Access to new markets both regionally and globally
  • A new, built-in customer base
  • An established product line
  • A larger pool of talent
  • New technology and physical assets

Through acquisition, your company may be able to remain a step ahead in existing markets while plotting expansion into new cities, states, regions or even countries. An acquisition strategy has the potential to expand your geographic reach and may even help improve or expand market share.

Other advantages may include expanding your existing customer and/or product base, while potentially introducing new products or customers. Absorbing existing customer relationships of the acquired company may reduce costs in one area of the business while allowing you to re-allocate costs and resources to other things like technology and talent.

Increasing your pool of qualified and experienced employees can be invaluable. Resources earmarked for training could possibly be allocated elsewhere. Meanwhile, diversification of talent may improve the performance of your existing workforce by leveraging best practices across the combined employee base.

Increase your profit margins

Acquisition has the potential to increase revenue and earnings if the right strategies and tactics are implemented. However, the devil is in the details, and it’s important to make sure you have a solid execution and integration plan in place. Assuming that’s the case, there are a few key reasons why earnings might grow after an acquisition, including:

  • Overhead optimization
  • More efficient use of assets
  • Improved purchasing power and economies of scale

Sales, marketing and administration can be some of the largest expenses companies bear. By eliminating redundant operating and administrative functions, you may be able to accelerate margin improvement post acquisition. The challenge comes in identifying where redundancies exist while making sure to retain critical institutional knowledge and relationships.

Asset efficiency or asset turnover means generating more revenue per dollar of assets. Improvements come from consolidating manufacturing and distribution locations, leveraging better manufacturing practices of the target, or automating inventory and ordering systems. With greater asset efficiency, you may be able to free up more working capital to invest elsewhere in the business.

You may also benefit from improved purchasing power and economies of scale. Whether it’s in office supplies or industrial equipment, larger companies with more purchases often benefit from greater spending volumes which can lead to discounted or lower cost purchases from vendors.

Where does the capital come from?

Sources of capital to support an acquisition are plenty and varied, though each comes with a unique set of pluses and minuses. One of the most common and well-known sources of capital is bank debt, which many companies use as “standard practice.” It’s generally the cheapest form of capital, though requires regular interest and principal payments that will impact your cash flow. However, seller financing and third-party equity investment are both potential alternatives.

Seller financing is a good option for business owners who lack the cash to pay for an acquisition and who may not qualify for traditional bank debt. In these situations, the seller acts as a lender, with similar terms to a bank, though securing this type of financing is generally faster than through a bank. A business owner should be aware, however, that when sellers offer this option, they are usually looking for a buyer with experience in the industry, a well thought out acquisition strategy and a solid business plan.

An equity investor, such as a private equity firm, specializes in buying a company or share of a company with the intention of selling at a later time. While there are typically no required cash interest or principal payments associated with equity financing, depending on the arrangement and terms negotiated, an equity investor may end up with either a majority or minority ownership stake. However, there may be more to what equity partners can offer beyond just a check, including certain operational, strategic and financial resources to help your company grow. For example, an equity partner with other investments in a similar industry as yours may be able to help you expand existing customer relationships and/or introduce you to new ones. An equity firm may also be able to help you build a formal sales team and business development process, train new managers and find and execute the acquisition you are contemplating.

Overall, it may be possible to accelerate growth through acquisition; and a thoughtfully considered and carefully executed acquisition strategy certainly has its advantages. While the expense of doing an acquisition can be a factor, there are a variety of worthwhile capital options to help you get your deal done. Besides, if you can meet your financial goals in less time through acquisition than you otherwise would by pursuing an organic growth strategy only, it’s certainly worth assessing the feasibility of such a strategy for your own business.

Brendan McCahill

Four Ways Technology Can Ease The Burden Of New FSVP Compliance Regulations

By Brendan McCahill
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Brendan McCahill

What if it was possible for importers, or the customs broker that imports food into the U.S. on behalf of shippers, to stop salmonella-tainted food before it arrives in the hands of a consumer? While there are assorted systems in place to prevent contamination, often times, grocery stores and other businesses are unable to track the supply chain of foreign food importers, leaving customers blind to the origin of a product.

Descartes FSVP InfographicThe U.S. Food & Drug Administration (FDA) is working to address this issue with the Foreign Supplier Verification Program (FSVP). The new program makes importers responsible for better tracking hazards, identifying their suppliers and ensuring that their food is compliant with processes that meet the FDA’s standards for preventive controls and safety.

On the surface, this visibility seems like a great benefit to both consumers and businesses. But what will it mean for importers as they try and keep up with reporting requests and new regulations?

To prepare businesses for the continuing list of FSVP regulations that must be implemented by 2019, here are four ways in which technology will ease the burden and make the food industry’s supply chain even stronger.

1. Gain a holistic view of the supply chain

For navigating FSVP specifically, technology provides food importers with an efficient way to identify and better trace a supplier network, as well as and a quick and easy way to locate D&B D-U-N-S® Numbers*. For importer self-filers and customs brokers, similar solutions enable them to streamline techniques to transmit data to U.S. Customs & Border Protection (CBP) in the Automated Commercial Environment (ACE) as their goods move across borders, as well as to store details, such as D&B D-U-N-S Numbers, Harmonized System (HS) codes and more.

Ultimately, food importers and customs brokers that enlist the expertise of one technology provider can better prepare for FSVP compliance. While piecing together a technology solution using multiple logistics technology providers may work in the short term, a forward-looking, compliance-centric approach that aligns with future regulations must be adopted – one that gives a holistic view of the supply chain via one service provider.

2. Identify and better trace the supplier network

Supplier verification is an additional area of FSVP whereby suppliers must undergo periodic review and approval, and must be identified in order to perform an effective supplier hazard analysis and evaluation. Accurately identifying suppliers is a highly complex task due to intricate supply chains, compound food formulations and the number of SKUs in a product line. Plus, a supplier ecosystem evolves over time for many reasons, such as changing cost and consumer demand. Simply put, managing a complex supplier network can be a drain on resources and costly. Luckily, technology can help.

Logistics solutions that feature periodic updates that adapt to changing supply chains can help food importers better target suppliers to ensure regulations are followed. It can also help focus on suppliers with higher shipment volumes to optimize data management and prioritize compliance responsibilities.

In the event a food code is subject to FSVP, customs brokers are required to input the importers’ name, mailing address, email address and D-U-N-S Number. Because the FDA’s consumer protection function is dependent on the entry process, brokers are aware of the added scrutiny shipments subjected to FSVP-related information will be under, especially if any of the above information is noted as Unknown (UKN). Logistics technology can help automate this process and ease custom entries, booking, security filings and more.

3. Streamline techniques to transmit important data

Transmitting data to the CBP as goods move across borders can be challenging in its own right. Basic customs issues include import/entry process, tariff classification, valuation and duty assessment.

Innovative technology solutions can help businesses go beyond the bare minimum to improve the speed and accuracy of submitting entry and Partner Government Agency (PGA) data to CBP. Users can receive and react to responses and customs status messages by exception. Proactive alert functionality can notify users of actionable items including rejections, intensive exams, requests for electronic invoices, Temporary Importation Bonds (TIB) expiration notices and more. On-demand solutions also enable brokers and forwarders the ability to run complex international operations more efficiently.

4. Dedicate D&B D-U-N-S numbers for imported food product

The D&B D-U-N-S Number was selected by the FDA as the recording system to identify importers by a common reference system. The FSVP regulation indicates that a D-U-N-S Number must be provided by an importer for each line entry of food product imported into the U.S.

Today’s complex food industry means importers often work with an extensive ecosystem of subsidiaries, affiliates and Doing Business As (DBA) divisions. To comply with FSVP, technology can help quickly locate the D&B unique identifier for each member of the network, and streamline the complicated process of managing each line entry of food product offered for importation into the U.S.

A tech-driven pathway forward

There is no doubt that the new FSVP regulation is complex. U.S. food importers are now responsible for ensuring compliance in an effort to improve the safety of food entering the U.S. This will require food importers to fully understand the regulation on a practical level and react accordingly, using technology to its fullest.

Leading businesses should consider the FSVP regulation as an opportunity to look forward and prepare. With the right logistics technology and processes in place, organizations can improve their readiness to enable compliance, improve data management and execute a holistic regulatory strategy to meet the new stringent requirements.

* D&B D-U-N-S Numbers are proprietary to D&B, are licensed from D&B and are for internal use only. 
D-U-N-S is a registered trademark of D&B.

Christopher Sheeren

How To Recruit The Best Leaders

By Christopher Sheeren
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Christopher Sheeren

Unless they want to shut off the lights upon retirement, private business owners have to think about succession planning. Even more, if all key customer and vendor relationships reside with the owner, there isn’t much value to the business without him or her. Building a strong leadership team and implementing a succession plan are essential to a company’s continued success.

Baby Boomers will be transitioning out of the workplace in vast numbers over the next decade. This exodus, particularly involving those in leadership or ownership positions, will result in substantial transfers of wealth as businesses are shifted across generations or to new owners.
Valuing physical assets, such as equipment and facilities, is relatively simple, but the value of firms that provide services or intellectual assets to clients is harder to define. Their valuation is heavily dependent on their reputations, relationships and management teams. As a result, the long-term survival for many of those businesses is highly reliant on strategic succession planning to build bench strength and the future leadership team.

Begin with a plan

Companies and owners who strategically plan for succession help ensure an orderly transition of management with minimal uncertainty, decreased productivity, fewer employee morale issues, and limited impact on day-to-day business. That’s true especially in family-owned firms, where emotions and personal issues can impede efforts.

However, according to data from CNBC and the Financial Planning Association, 78 percent of small-business owners intend to fund their retirement by selling their company, yet less than 30 percent of companies have a written succession plan.

The lack of planning among larger organizations is even more pronounced. Less than 25 percent of private company boards have an official succession plan, according to the National Association of Corporate Directors.

Branding and clarifying the role

The transition to new leadership – and possibly ownership – doesn’t happen overnight. It may happen faster if the company is known as a great place to work and can provide a successful career path. Competitive compensation and benefits are important, but so is finding a good fit for the position and its responsibilities. Developing a clearly defined role (and the compensation package ranges) will help an owner focus his or her efforts on finding the right person.

Consider the following when defining the leadership role:

  • How many years of experience in a similar role does a candidate need?
  • What management style fits the culture?
  • What education, qualifications or knowledge of the industry must the candidate possess?
  • What communication skills does a candidate need? Does the role require negotiating, establishing direction, and instilling confidence from the board of directors, clients, staff and others?

Recruiting options

Besides strategically determining the need for succession planning or backfilling, it is important to develop a communications/recruiting strategy for the position. This includes determining where to look and establishing a budget for the effort.

Internally

Many companies either assume from the start that positions require new blood or that they should automatically promote from within. Growing staff internally by increasing levels of responsibility is important when grooming a trainee for the future. When companies immediately look to fill positions from the outside, it can be demoralizing to employees who wish to advance. Being overlooked can spur people to seek opportunities elsewhere, costing the company valuable employee experience. To be effective and efficient, fully vet internal candidates before searching outside, and make sure they understand what the position requires. It also helps to ask staff what they believe is needed as they may offer fresh insight.

Spreading the word internally also allows companies to mine employee networks. A 2016 Society of Human Resources Management (SHRM) survey indicated that referrals are the top source of new hires for 96 percent of companies with at least 10,000 employees and for 80 percent of firms with under 100 workers.

The do-it-yourself approach

Companies that do not do a lot of recruiting often try to handle the task of finding new leaders themselves. Job postings, LinkedIn, industry sources and other platforms can work, particularly if the recruiter or person heading the search has access to a pipeline of great contacts.
However, relying solely on job listings is usually a poor sourcing strategy. While there may be outstanding candidates scanning the listings at that point, the candidate pool will be limited to those currently looking for a position as opposed to the best possible options. A do-it-yourself talent search can be effective, however, filling a higher-level position often requires more than a single approach.

Outsourcing the recruitment effort

Engaging an executive search firm or professional recruiter opens up a hidden market of talent. Recruiters remain connected to ‘the trenches’ because their livelihoods depend on it. They have typically built up a network of contacts already performing similar roles and can tap into it and proactively target (or ‘head hunt’) the best possible candidates.

Turning to a professional search firm is not cheap. Typically, the cost is a percentage of the first year’s compensation (25 to33 percent is typical) or a flat finder’s fee. But, searching for talent that is critical to a company’s succession planning is not an area to skimp.

Other considerations

A best recruiting practice is to meet with someone at least three times, in three different settings (e.g. office, coffee, and dinner). Each meeting can take on a different tone to closely analyze the individual. Thought-provoking questions can help determine management aptitude, and the more social engagements can help in assessing the personality traits that comprise effective leadership and whether or not the person will fit in.

Give a candidate a thorough review in person, with a background check, and by checking references before making a final offer. Additionally, consider bringing a representative from a key partner, a trusted advisor, or an important client to the dinner meeting and ask their opinion of the candidate.

To ensure success, set aside an adequate transition and training period. Then, let everyone in key positions know about it. This demonstrates to employees that leadership wants to make the transition as smooth as possible.
Too many business leaders and owners fail to recognize the importance of succession planning and developing the best future leaders until the end of their careers.

While time-consuming, succession planning is truly planning for future success. Realistically, preserving an organization’s value for the future can be as challenging as building that value in the first place. Hiring professionals who work with companies on building leaders, transferring the equity of businesses in all industries, and valuation is a wise investment.

Accreditation

Why Accredited Services Increase Business Opportunities And Contribute To The Harmonization Of Regulations

By Natalia Larrimer, Jacqueline Southee, Ph.D.
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Accreditation

Accreditation is an internationally accepted independent oversight process for maintaining operational standards and ensuring confidence. It is accepted by many governments and private industries, including at various levels of the global food supply.

Recognized within the food industry and endorsed by the Global Food Safety Initiative (GFSI), the process of accredited certification has become essential for business.

In the United States, the Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), in its rule on accredited third-party certification, incorporates the accreditation process for oversight over third-party certification bodies certifying foreign food facilities manufacturing for import into the United States.

With accredited services increasingly becoming an integral part of business operations, many wonder how the processes of accreditation and certification work.

Accreditation is the process of ensuring that an organization has the necessary technical competence to perform a specific task, and has met and continues to meet a specific set of operational requirements. An accreditation body (AB) uses internationally established techniques and procedures to assess conformity assessment bodies (CABs) against recognized standards to ensure their impartiality, competence, and ability to produce consistently reliable, technically sound and impartial results.

Accreditation provides formal recognition that an organization is competent to carry out specific tasks, and provides an independent assessment of conformity assessment bodies (CABs)1 against recognized standards to ensure their impartiality and competence. Accreditation provides assurance to a CAB’s customers and industry that the CAB continuously operates according to internationally accepted criteria applicable to CAB’s scope of accreditation.

Although there is flexibility for an AB to design its accreditation process within the constraints of ISO/IEC 17011, Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies, the standard to which all internationally recognized ABs must conform, some aspects are mandatory.

As part of the application process, the applicant for accreditation submits information about the desired scope of accreditation and its documented quality management system. The AB conducts a document review to verify that the applicant has documented all management system requirements specified in the relevant criteria and any other applicable requirements. Additional requirements could include, for example, those mandated by a specific regulatory authority or industry. During the assessment, through witnessing of the CAB conducting a conformity assessment activity, interviews of personnel, and review of records and other objective evidence, the AB’s assessment team verifies the CAB’s technical competence and implementation of the quality management system.

The applicant is required to provide corrective action for all identified deficiencies. Only after all identified issues have been addressed can the accreditation decision process begin. To ensure that the accreditation decision is impartial, members of the assessment team do not take part in the decision. The designated decision maker, which may be a group or an individual, is responsible for reviewing the assessment team’s recommendation and ensuring that all accreditation requirements have been met by the applicant and are properly documented before granting accreditation.

A certificate and scope of accreditation are issued only after a favorable accreditation decision.

Once accredited, the CAB is regularly re-assessed to ensure continued conformance to the accreditation requirements, and to confirm that the required standard of operation is being maintained.

To ensure transparency, the AB is required to make publicly available information on the status and scope of accreditation for each accredited CAB. Any changes occurring after initial accreditation, such as suspension for all or part of the scope of accreditation, are published on the AB’s website.

It is important to note while ABs provide oversight over CABs, internationally recognized ABs are themselves subject to regular oversight from organizations orchestrating the harmonization and recognition of the accreditation process internationally.

The International Laboratory Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF) provide this international oversight. ABs that are signatories of the ILAC and/or IAF mutual recognition agreements (MLAs or MRAs) must conform with the requirements of ISO/IEC 17011 as applicable program-specific requirements, and are admitted to the agreements for a specific capability, for example, as an accreditor for testing labs or for management systems certification bodies. Technical competence of the AB and conformance to the requirements is verified through rigorous on site evaluation by other member of the IAF or ILAC community.

Without international oversight, there would be no evidence or confirmation that an AB operates in accordance with international requirements when providing oversight of accredited CABs. This oversight provides assurance that the AB understands the CAB’s process and can attest to the CAB’s competence.

The IAF, MLA and ILAC agreements are internationally recognized forms of approval; signatories have demonstrated their compliance with specified standards and requirements. Accreditation by a signatory of the ILAC MRA and/or IAF MLA provides assurance that decisions are based on reliable results, thus minimizing risk.

This is of particular importance in the constantly evolving global food-supply network. Many specifiers, such as regulatory authorities, have acknowledged the importance of credible accreditation programs.

A number of government agencies in the United States and around the world, including the U.S. Consumer Product Safety Commission (CPSC), U.S. Environmental Protection Agency (EPA) and the Canadian Food Inspection Agency (CFIA), have mandated accreditation by an internationally recognized accrediting body for their programs.

Accreditation within the MLA/MRA process helps regulators meet their legislative responsibilities by providing assurance that testing, inspection and evaluation results are issued by organizations whose technical competence and compliance with specified criteria has been verified by an independent third party. It provides assurance to stakeholders, such as the regulatory authorities, that the accredited CAB operates in accordance with recognized and accepted criteria.

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Status and Outlook of Food Labeling Proposals

By Brian Ronholm, Karen Ellis Carr
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When the National Bioengineered Food Disclosure Standard was signed into law in July 2016, it represented the culmination of an extended legislative and regulatory period of activity on food labeling issues in general. As the focus shifts toward the implementation of these labeling proposals – such as requirements for bioengineered food disclosure, calorie disclosure on menus, and updating the nutrition facts panel – the debate over food labeling issues will remain very active, and new labeling proposals are certain to arise, including ones directly impacting food safety.

Bioengineered Food Disclosure

The National Bioengineered Food Disclosure Standard was enacted into law to preempt a patchwork of differing and conflicting national, state and local requirements that were going into effect or being proposed at the time. The legislation, which acknowledges the proven safety of agricultural biotechnology products while simultaneously ensuring consumers have access to more information about the foods they purchase, was enacted with strong bipartisan support. Because this labeling mandate is based on a desire to enhance consumer information, and not address any safety concerns, Congress delegated responsibility for implementing the disclosure standard to the Agricultural Marketing Service (AMS) within the U.S. Department of Agriculture (USDA).

The disclosure standard, which will be developed by USDA through rulemaking, is intended to apply to a broad category of foods and provide several options for mandatory disclosure, including text on packaging, the use of a symbol, or an electronic or digital link. Additional flexibility will be provided for small food manufacturers and food in very small packages.

Under the law, certain foods are excluded from the disclosure requirement, including food served in restaurants or similar retail food establishments, or food produced by very small food manufacturers and any food that is derived from an animal solely because the animal consumed feed produced from a bioengineered substance. Food products that have meat, poultry or egg as their main ingredient would remain subject to labeling under other federal statutes. The legislation also would ensure that food products certified under the national organic program could display a “non-GMO” label or other similar claim in addition to the USDA organic seal.

Study on Potential Challenges

The law also required USDA to conduct a study to identify any technological or other barriers to disclosure and offer additional disclosure options if the Secretary of Agriculture determined that barriers existed. While the study, which was released in September 2017, did acknowledge some notable challenges, it concluded that most consumers seeking information on their food purchases would be able to access this information, given the proper education and tools.

Challenges identified by the study include: consumers not recognizing the on-package digital link or not associating it with food information; retailers’ unfamiliarity with digital links and inability to assist consumers; some consumer challenges in accessing the tools needed to scan a link; consumers struggling with mobile applications (apps), regardless of comfort level with technology; and broadband connectivity and connection speed.

Although researchers observed these key technological challenges that prevented nearly all participants in the study from obtaining the information through electronic or digital disclosure methods, the study asserted that the challenges could be overcome through appropriate implementation of the law.

Outlook

USDA Secretary Sonny Perdue has expressed his commitment to meeting the implementation deadline of July 29, 2018 for the National Bioengineered Food Disclosure Standard. This summer, the department collected feedback on thirty questions under consideration in connection with the rulemaking process, and released the accessibility study required under the law close to the deadline set by Congress. The fact that consumer groups filed suit to compel the study’s release shortly after the deadline passed serves as an early indicator that all aspects of USDA’s implementation of the law will remain under close scrutiny and, in all likelihood, be the subject of additional litigation.

There also has been some indication that the compliance date will coincide with another labeling requirement in the pipeline – the update to the Nutrition Facts Label.

Update to the Nutrition Facts Label

Original vs. New Format – Infographics to Help Understand the Changes

On May 27, 2016, the Food and Drug Administration (FDA) published the final rules updating the Nutrition Facts label for packaged foods to reflect new scientific information, including the link between diet and chronic diseases such as obesity and heart disease. In its announcement, the FDA indicated that the new label would make it easier for consumers to make better-informed food choices.

While the familiar look of the nutrition facts panel remains, FDA is proposing changes that would include an emphasis on Calories by increasing the font size and bolding it. The font size for serving size and servings per container also will be increased.

Other notable changes include requiring manufacturers to declare the actual amount of vitamin D, calcium, iron and potassium, in addition to the percent Daily Value, and to better explain in the footnote what percent Daily Value means. The rule also requires that the label include Added sugars in grams and as percent Daily Value in order to reflect recent scientific data showing that it is difficult to meet nutrient needs while staying within calorie limits if a person consumes more than 10 percent of total daily calories from added sugar.

The rule also requires updates to serving sizes on the nutrition facts label so that they are based on amounts of foods and beverages that people are actually consuming. For example, for packages that are between one and two servings, the rule requires that the calories and other nutrients be labeled as one serving because people typically consume it in one sitting.

Additional details of the update to the Nutrition Facts Label can be found on the FDA web site.

Outlook

On June 13, 2017, FDA announced that it would delay the compliance date for the final rules updating the Nutrition Facts Label, adding that the new date would be forthcoming. In a Federal Register notice on October 2, FDA announced the new compliance date of January 1, 2020.

Earlier in the year, a group of food industry trade associations and officials requested that FDA delay the compliance date for three years, asserting that it should be aligned with the compliance date for USDA’s Bioengineered Food Disclosure Standard. Industry groups had been arguing that aligning these dates would eliminate the need to change labels twice.

Because the Administration has hinted support for aligning the compliance dates for USDA disclosure and FDA labeling requirements, FDA could announce another delay as the January 2020 date approaches.

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