Tag Archives: GMP

Steve Ardagh
FST Soapbox

What’s in Your Glove?

By Steve Ardagh
Steve Ardagh

In the food processing and food service industry, glove wearing is meant to protect, not infect. That’s the theory, but not necessarily the reality.

Over 100 billion protective gloves—over 90% of the national supply—are imported into the U.S. each year from factories scattered throughout Asia. A good proportion of the gloves are destined for a substantial proportion of the 700,000 workers in meat and poultry processing and fresh produce sectors, as well as a proportion of the 14 million workers in the food service sector.

The FDA recently specifically classified gloves as Zone 1 Food Contact Surfaces, meaning in direct contact with ready to eat (RTE) ingredients or finished food products, and at the highest risk for product contamination.

The Food Safety Gap

However, there is a vital and contradictory gap in the oversight of quality assurance within FDA regulations. Here’s how the gap occurs. The FDA Compliance (21CFR177) for a glove to be called food-compliant involves a one-time single glove test conducted by overseas factories with an FDA-approved lab. The test is focused solely on chemical migration from the glove to food, and unless the manufacturer changes material ingredients, the test has no expiry date. “Food Compliant” gloves are not tested for bioburden, cleanliness or performance.

Complementary regulations also listed under FDA Title 21 Part 110 – Good Manufacturing Practice (GMP 21 CFR 110.10) require gloves to be “intact, clean, and sanitary” and “impermeable.” Upon arrival in the U.S. however, there is no requirement from the FDA for gloves to arrive “intact, clean, and sanitary” and “impermeable.” Gloves with FDA (21 CFR 177) compliance are imported “without the benefit of inspection.”

Why Does This Matter?

If you went down a food processing line and told every glove wearer that there was a 46% chance that the gloves they were wearing contained human fecal indicators, or potentially contained more than 250 unique and viable pathogens, what do you imagine the reaction would be? What would consumers think knowing the food on their dinner table might have been handled by potentially contaminated gloves?

The findings of a five-year study commissioned by Eagle Protect and undertaken by the B. Michaels Group revealed widespread risk of contamination in the disposable glove industry. The findings were presented at the 2019, 2021 and 2022 International Association for Food Protection (IAFP) annual meetings. Results found human fecal indicators on 46% of new and unused off-the-shelf gloves along with other foodborne pathogens and microbes including E. coli, Bacillus cereus, Bacillus anthracis, Listeria monocytogenes, Clostridiales difficile, Staphylococcus, Salmonella, Pseudomonas aeruginosa, Streptococcus pneumonia, and various fungi including Aspergillus.

Michaels, a leading microbiologist, ran the study, which involved independently testing 2,800 new and unused U.S. glove imports representing 26 different brands (approximately 25% of the ~100 SE Asian glove factories). Over 250 different viable microbial species were found on both the interior and exterior surfaces of the tested gloves.

Based on both observed conditions and events at SE Asian glove factories, as well as characteristics of microorganisms identified on or in disposable gloves, it was ascertained that microbes originate from contaminated water sources (rivers, drainage ditches and ponds). Once introduced into glove manufacturing facilities, contaminated rinse water circulates in and out of leaching or wash tanks, often not heated sufficiently, that are responsible for removing soluble chemical residues from glove surfaces.

In addition, gloves made of poor-quality materials can rip and tear, with particles finding their way into food products. Glove toxins can also contribute to a range of potential health issues including carcinogenicity, endocrine disruption, fertility impairment, metabolic disorders and skin diseases including dermatitis. For companies, there are issues with potential recalls, liability, worker compensation and consumer health.

How Can This Be?

In addition to dirty, polluted, contaminated water sources at factories, poor filtration, poor raw materials, unhygienic packing, poor hygiene practices by factory staff, lack of oversight and care by factory owners and, most important, lack of procurement standards on the part of U.S. corporate, business and institutional glove purchasers allow this to go on.

What Is the Solution?

There is little pressure on foreign glove manufacturers to self-regulate and improve their practices, unless businesses refuse to purchase from companies that cannot demonstrate acceptable standards. Therefore, the onus is on corporate and business purchasers of gloves. They need to be better educated about glove safety, including the risks of billions of potentially contaminated gloves on the hands of their workers in factories and plants, the potential risks to end consumers, and the value of adopting of clear standards for procurement that supersede the overwhelming criteria of “how cheap can we get them?”

Ask 1: Do manufacturers use Safe Ingredients? Are the raw materials tested to ensure consistency of manufacturing and to ensure the gloves are free of potentially toxic chemicals that might impact user and consumer health or contaminate food?

Ask 2: What is the Performance of the glove? Strength and durability tests and Acceptable Quality Level (AQL) further ensure consistent glove performance. AQL (maximum pinhole defects per 100 gloves) levels are required for medical and sterile gloves. There are no stated requirements by the FDA for Food Compliant Gloves. However, the standard should be at 2.5 (examination grade) or lower for food safety.

Ask 3: Are the gloves Clean? Bioburden on both the inside (skin contact) and outside (food and patient contact) can be tested to identify fungal and microbial contaminants that could pose a threat to the glove wearer, and the product handled.

Ask 4: Are the gloves Skin Tolerant? Poor quality gloves are often the cause of skin irritation. FDA Food Compliance does not ask for cleanliness, physical standards or toxicity tests. Gloves can be tested for a wide variety of chemicals and toxic exposure that could result in dermal or systemic toxicity, ensuring against skin irritation and occupational skin diseases of the wearer.

Ask 5: Is the factory making your gloves independently certified and does it use child or forced labor? Does your supplier or distributor have credentials such as being a registered B-Corp or accreditation by WRAP (Worldwide Responsible Accredited Production) organization, SEDEX (Supplier Ethical Data Exchange) or similar independent labor and quality verifications?

Ask 6: Is the product traceable? Does your glove box come with a QR code in which manufacturing activity is captured, secured and shared across the supply chain?

Consortium of Agreement to be Better Informed

The sight of blue gloves on a production line is universal. So too is the assumption that these gloves are safe by being “intact, clean, and sanitary.” Yet, we have learned that this is not always true. The only realistic action that can improve glove safety is for corporations to adopt standards, for glove wearers to demand quality gloves and for consumers to start asking “What’s in your gloves?”

Although regulators can set the tone that encourages industry to do the right thing, ensuring glove safety really does come down to suppliers and buyers uniting in a full-throated demand that there be a reduction in the risk of glove contamination in the U.S.

There needs to be a consortium of agreement from purchasers of protective gloves to shift from the lowest common cost denominator (cost) to a higher standard. The top 15 food producing companies in the U.S. have a combined market capitalization of $1.4 trillion so there is room to take some extra safety steps to implement a Supplier Code of Conduct using a system to conduct assessments and lab tests and to monitor outcomes.

Better and more informed decisions can be made by procurement departments. Food processing and food service companies all have safety and sustainability criteria; glove safety should be among the standards to adhere to.

We should be able to feel more at ease knowing that the gloves our food processing and service personnel put on are of the highest standards. This should be a paramount concern, not just to experts, but also the public who remain mostly unaware of the risks and dangers in glove manufacturing. Therefore, it is incumbent on all the industries involved in the making, selling and purchasing of gloves to adopt and advocate for a robust system for the manufacturing, tracking and quality assurance of gloves.

Sonia Acuña-Rubio
Allergen Alley

Reducing the Risk of Undeclared Food Allergens

By Sonia Acuña-Rubio
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Sonia Acuña-Rubio

Each year, 200,000 people in the U.S. require emergency medical care due to allergic reactions to food. Common foods that trigger allergic reactions include certain types of seafood, dairy, nuts, wheat, soy and sesame. For some, food allergy reactions can be serious and even life-threatening, requiring immediate treatment via the drug epinephrine.

Allergens are also one of the leading causes of food recalls globally. As food allergies continue to impact individuals and families across the nation, food manufacturers and distributors must be vigilant when manufacturing, packaging and selling foods to consumers.

Understanding Allergen Regulations

Many countries aim to protect individuals with food allergies by enforcing government regulations. Such regulations can require product manufacturers to disclose ingredients in packaged food and beverages.

In the U.S., the FDA recognizes nine major food allergens: crustacean shellfish, eggs, fish, milk, peanuts, tree nuts, sesame, soybeans and wheat. Sesame is the newest recognized allergen and was added in 2022 as part of the Food Allergy Safety, Treatment, Education and Research (FASTER) Act. These allergens must be identified on labels for American food products.

Similarly, in Canada, the Canadian Food Inspection Agency (CFIA) has a list of 11 priority allergens, which includes eggs, milk, mustard, peanuts, crustaceans and mollusks, fish, sesame, soy, sulfites, tree nuts, wheat and triticale, which must be disclosed on pre-packaged foods sold in the country.

In both countries, products may be recalled due to improper labeling and announced via public notice. (A comprehensive list of recognized food allergens by country can be found on the Food Allergy Research and Resource Program (FARRP)’s website.)

Activating Your Allergen Management Program

A comprehensive and effective allergen management program protects your consumers and your company and is necessary to meet regulatory and GFSI (Global Food Safety Initiative)–benchmarked standard requirements. Creating an allergen management program involves developing processes and protocols and training employees to follow them.

Allergen cross-contact can occur when an allergenic food or ingredient is unintentionally incorporated into a food product. Food manufacturers and distributors should have a program that includes an allergen risk assessment, which helps to identify and manage any unintentional allergen contamination throughout the supply chain while tracing them throughout the facility. Good Manufacturing Protocols (GMP) should be followed for personal hygiene, handwashing, sanitation programs and more.

Managing Your Suppliers

Supplier communication is key to identifying allergens in raw materials. Use current supplier specifications and ingredient statements to identify allergens coming into the facility. Be alert for “may contain” statements and review your supplier’s allergen control policies and procedures.

In today’s food production environment, there are more supply chain disruptions than ever before. If there is a change in your raw materials or supplier, make sure that all documentation and finished product labels are updated.

Additional best practices when working with suppliers include:

  • Have a policy in place for label changes, noting that if a label from a product you purchase from a supplier changes, you must be notified of the change prior to the change being made and put into effect.
  • Ask for updated specifications/allergen information from suppliers on an annual basis. This could help to quickly identify issues if the supplier neglected to inform you of a change.

By identifying and listing sources in the facility, you can detect any ingredients and processing aids that contain or may contain allergens due to cross-contact or carry-over products. It is also important to prepare a master list of all ingredients in the facility and consider both primary and secondary ingredients, such as spices, colors and flavors.

Ask questions along the production process, identifying potential risks in recipes/formulas, traffic flow (of people, materials, and waste), potential crossovers of conveyors or pipe systems, shared equipment, storage practices, material segregation and airflow.

Avoiding Allergen Cross-Contact

Ensure that raw materials are labeled and segregated with incoming ingredient specification checks by weighing powders containing unique allergens in a separate and labeled area, covering totes or containers containing allergenic ingredients during transfer, and controlling the ventilation over lines where protein powders are dumped. Use product scheduling to maintain proper segregation.

Designate dedicated equipment, including utensils, if possible, as well as production sequencing or cleaning between allergen changeovers. Refrain from using original ingredient containers that previously held allergens. At the end of an allergen production run, conduct a complete and validated allergen clean.

Use documented visual inspection on each piece of equipment and environment between allergen changeovers and conduct regular labeling checks against the approved label/package design for each item produced. A third-party partner can be used to help develop and maintain supplier specifications, audit formulations, and review current packaging.

Protecting Consumers and Business Reputation

While ensuring products are free of any undeclared allergens may seem more challenging than ever before, establishing the right programs and practices can keep both your business and consumers healthy and safe. Implementing an allergen management plan, supplier checks, and allergen controls is key to avoiding cross-contact in the production process and throughout the supply chain, ensuing fewer disruptions in the manufacturing process, and ultimately, building trust with consumers.

Koshal Ram and Ranjeet Klair

Acheson Group Expands into India

By Food Safety Tech Staff
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Koshal Ram and Ranjeet Klair

The Acheson Group (TAG), a global food safety and public health consulting team led by David Acheson, MD, former FDA Associate Commissioner for Foods, has expanded its operations to India.

As part of the expansion, TAG brought on two new team members. Food Safety Specialist Koshal Ram has nearly three decades of experience working in low-acid agri-food manufacturing and has held technical and global leadership roles managing supply chain food safety and product quality with multiple companies. Ram has a diploma in Quality Assurance and ISO from the University of Chennai, India. He speaks four languages (English, Hindi, Tamil and Kannada) and is a Preventive Controls Qualified Individual (PCQI) and an FSVP Qualified Individual. He is trained in Food Safety and Standards Act 2006, ISO 2000 requirements, QAS validation and verification of HACCP Plans and QAS development and implementation of HACCP Plans, Acidified Food Manufacturing School (21CFR section 108.25(f) and 114.10) and FDA Acidified Foods.

Ranjeet Klair will work in conjunction with Ram at TAG India as Director of Food Safety. She brings more than two decades of industry experience working with Canadian, U.S. and global food retailers, production plants and certification bodies in food safety, quality assurance and regulatory compliance. Klair holds a Master of Science degree in Food Sciences, Master of Global Food Law (Jurisprudence) degree and a Bachelor of Applied Science and certification in International Food Laws and Regulations. Along with completing a certification program for International Food Laws and Regulations, she is a BRC, FSSC22000, HACCP, PCQI, FSVP trainer and BRC, SQF, FSSC, ISO 22000, Gluten-free, GMP and Canada GAP lead auditor.

As a key component of service to India, TAG will provide expertise and resources to assist exporters in food safety efforts and domestic and foreign standards and regulatory compliance.

“With TAG’s 10-year anniversary quickly approaching, we are excited to bring on valuable new TAG Team members who can help further expand our business to different areas of the world,” said Dr. Acheson, TAG CEO and President. “Ranjeet’s and Koshal’s expertise and ability to work onsite with clientele throughout India enables us to bring TAG support to India.”

Earl Arnold, AIB International
FST Soapbox

HACCP is the Past, Present and a Building Block for the Future

By Earl Arnold
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Earl Arnold, AIB International

“Food safety plan” is a term often used in the food industry to define an operation’s plan to prevent or reduce potential food safety issues that can lead to a serious adverse health consequence or death to humans and animals to an acceptable level. However, depending on the facility, their customers, and or regulatory requirements, the definition and specific requirements for food safety plans can be very different. To ensure food safety, it’s important that the industry finds consensus in a plan that is vetted and has worked for decades.

One of the first true food safety plans was HACCP. Developed in 1959 for NASA with the assistance of the food industry, its goal was to ensure food produced for astronauts was safe and would not create illness or injury while they were in space. This type of food safety plan requires twelve steps, the first five of which are considered the preliminary tasks.

  1. Assemble a HACCP team
  2. Describe the finished product
  3. Define intended use and consumer
  4. Create process and flow diagram
  5. Verify process and flow diagrams

This is followed by the seven principles of HACCP.

  1. Conduct the hazard analysis
  2. Identify critical control points
  3. Establish critical limits
  4. Establish monitoring requirements
  5. Establish corrective actions for deviations
  6. Procedures for verification of the HACCP plan
  7. Record keeping documenting the HACCP system

HACCP is accompanied by several prerequisites that support the food safety plan, which can include a chemical control program, glass and brittle plastics program, Good Manufacturing Practices (GMPs), allergen control program, and many others. With these requirements and support, HACCP is the most utilized form of a food safety plan in the world.

When conducting the hazard analysis (the first principle of HACCP), facilities are required to assess all products and processing steps to identify known or potential biological, chemical and physical hazards. Once identified, if it is determined that the hazard has a likelihood of occurring and the severity of the hazard would be great, then facilities are required to implement Critical Control Points (CCP) to eliminate or significantly reduce that identified hazard. Once a CCP is implemented, it must be monitored, corrective actions developed if a deviation in the CCP is identified and each of these are required to be verified. Records then also need to be maintained to demonstrate the plan is being followed and that food safety issues are minimized and controlled.

HACCP is, for the most part, the standard food safety plan used to meet the Global Food Safety Initiative (GFSI) standards. This is utilized in various third-party audit and customer requirements such as FSSC 22000, SQF, BRC, IFS and others. These audit standards that many facilities use and comply with also require the development of a food safety management system, which includes a food safety plan.

Further, HACCP is often used to demonstrate that potential food safety issues are identified and addressed. FDA has adopted and requires a regulated HACCP plan for both 100% juice and seafood processing facilities. USDA also requires the regulated development of HACCP for meat processing and other types of facilities to minimize potential food safety issues.

For facilities required to register with the FDA—unless that facility is exempt or required to comply with regulated HACCP—there is a new type of food safety plan that is required. This type of plan builds upon HACCP principles and its steps but goes beyond what HACCP requires. Under 21 CFR 117, specific additions assist in identifying and controlling additional food safety hazards that are on the rise. This includes undeclared allergen recalls, which constituted 47% of recalls in the last reportable food registry report published by FDA.

Prior to developing this plan, FDA provided recommendations for preliminary steps that can be completed and are essential in development of a robust food safety plan but are not a regulatory requirement. The steps are very similar to the preliminary tasks required by HACCP, including the following:

  1. Assemble a food safety team
  2. Describe the product and its distribution
  3. Describe the intended use and consumers of the food
  4. Develop a flow diagram and describe the process
  5. Verify the flow diagram on-site

Their recommended plan also requires a number of additional steps, including:

  1. A written hazard analysis. Conducted by or overseen by a Preventive Controls Qualified Individual (PCQI). However, this hazard analysis requires assessing for any known or reasonably foreseeable biological, chemical, physical, radiological, or economically motivated adulteration (food fraud that historically leads to a food safety issue only). You may note that two additional hazards—radiological and EMA—have been added to what HACCP calls for in the assessment.
  2. Written preventive controls if significant hazards are identified. However, similar preventive controls are different than a CCP. There are potentially four types of preventive controls that may be utilized for potential hazards, including Process Preventive Controls (the same as CCP), Allergen Preventive Controls, Sanitation Preventive Controls, Supply Chain Preventive Controls and Others if identified.
  3. A written supply chain program if a Supply Chain Preventive Control is identified. This includes having an approved supplier program and verification process for that program.
  4. A written recall plan if a facility identified a Preventive Control.
  5. Written monitoring procedures for any identified Preventive Control that includes the frequency of the monitoring what is required to do and documenting that monitoring event.
  6. Written corrective actions for identified Preventive Controls in case of deviations during monitoring. Corrective actions must be documented if they occur.
  7. Written verification procedures as required. This could include how monitoring and corrective actions are verified, procedures themselves are verified, and calibration of equipment as required. Also required is training, including a Preventive Control Qualified Individual. Additional training is required for those individuals responsible for performing monitoring, implementing corrective actions, and verification of Preventive Controls. Further, all personnel need to have basic food safety training and all training needs to be documented.

While the term “food safety plan” is used widely, it’s important that operations don’t just use the term, but enact a plan that is vetted, proven to work, and encompasses the principles of HACCP. Doing so will help ensure that their facility is producing foods that customers and consumers will know is safe.


Are You Ready for the Produce Rule? You Just Might Be

By Marsha Madrigal
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At last the new Produce Rule is out, issued on November 13, 2015.  For the first time in FDA history, the rule establishes a science-based minimum standard for growing, harvesting, packing and holding of fruits and vegetables grown for human consumption.  The rule can be found in Part 112 of the Code of Federal Regulations (CFR). It applies to both domestic and imported produce.

The new rule provides assurance that produce on the market is not adulterated under the Food, Drug, and Cosmetic Act.  It will accomplish this by establishing procedures, processes and practices that are known to minimize the risks of serious adverse health consequences or death to humans, and to prevent the introduction of known biological hazards into and or on produce.

The definition for a farm, covered under the rule, includes two kinds of farming operations, primary production farm and secondary activities farm. The primary production farm operates under one management, and the secondary activities farm is an operation. Where as the primary production farm owns, or jointly owns, a majority of interest in the secondary activities farm.

Food Safety Consortium
During the FDA Town Hall, an audience member asks about the Produce Rule and the work being done with Mexico. Watch the video

For the most part, the new mandated FDA Produce Rules, mirror what farmers, packers and others in the farm business have been doing all along.  For years now, produce buyers have required some kind of written guarantee from their suppliers such as a third-party audit certificate showing that the supplying farm or packing shed is complying with the farm food safety standards. Most farms and packing sheds have already undergone, if not one, but perhaps two or more third-party audits such as a Good Agricultural Practices (GAP) or, one of the Harmonized GAP audits, or a Good Manufacturing Practices (GMP) audit, or one of the Global Food Safety Initiative (GFSI) audits such as GlobalGAP, Safe Quality Foods (SQF) or BRC Global Standards (BRC).

This means that those covered under the Produce Rule for growing, harvesting, packing and holding of fruits and vegetables grown for human consumption and have received a third-party audit should have no trouble achieving compliance with the new Produce Rule.

The above-mentioned third-party standards cover most aspects of the key requirements of the Produce Rule regarding agricultural water, biological soil amendments, domesticated and wild animals, worker training, health and hygiene, and equipment, tools, and buildings.

However, some key requirements of the new rule not noted in existing third-party standards include:

  • Water testing of untreated water, sample collection and survey creation for agricultural water.
  • Microbial standard limits for detectable amounts of microorganisms to include Listeria monocytogenes, Salmonella species, and E. coli 0157:H7 for the treatment process of soil amendments, including manure.
  • The final Produce Rule includes requirements to help prevent the contamination of sprouts. For example, requires testing of spent sprout irrigation water for pathogens and requires environmental monitoring for Listeria. Documentation or letters from seed and/or bean supplier for the prior treatment of seed and beans are acceptable.
  • The requirements of Domesticated and Wild Animals relies more on monitoring and assessing conditions during growing season. If you find evidence of potential contamination like animal excreta, you must take action and evaluate whether produce can be harvested or if there is a likelihood of contamination. The produce must not be harvested.

This rule does not apply to:

  • Farms that have an average annual value of produce sold during the previous three year period of $25,000/yea
  • Produce for personal or on-the farm consumption
  • If the produce is on the list of “rarely consumed raw commodities” such as sweet potatoes and
  • A food grain such as wheat or oats

The rule provides also for exemptions:

  • Produce that will receive commercial processing (kill-step) to reduce microorganisms of public health concerns.
  • Provides a qualified exemption and modification requirement for farms that meet certain requirements based on monetary value and direct sales to qualified end users such as consumers or restaurants. The farm must also meet associated modified requirements like establishing and maintaining certain documentation.

Under certain conditions the FDA may withdraw a farm’s qualified exemption.

The rule focuses on sources of produce contamination found in the past: Agricultural water, biological soil amendments, domesticated and wild animals, worker training, health and hygiene, and equipment, tools and buildings.

This rule and others under FSMA such as Preventive Controls for Human Food, Preventive Controls for Animal Food, and the Foreign Supplier Verification Program are a long overdue yet great achievement for FDA. The agency now shifts its gear into focusing on preventing food safety problems instead of reacting to food safety outbreaks.

FDA estimates that about 348,000 illnesses per year will be prevented by the implementation of this rule.

The compliance dates for the new rule are staggered and based on business size.


  1. Produce Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
  2. FSMA Webinar Series: Final Rules for Produce Safety, Foreign Supplier Verification Program (FSVP), and Third Party Auditors
Timothy Ahn, LRQA
FST Soapbox

The Real Cost of Not Having an Effective Food Safety Management System

By Timothy Ahn
Timothy Ahn, LRQA

If you watch the evening news or read the local newspaper, the chances are pretty good that you will read or see something about a food safety concern or incident.

Consumers and Foodborne Illness
An estimated 1 in 6 Americans fall victim to a foodborne illness annually.

While the American food supply is among the safest in the world, the Federal government estimates that there are about 48 million cases of foodborne illness annually—the equivalent of sickening 1 in 6 Americans each year, according to Foodsafety.gov. And each year these illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths. Five types of organisms—Salmonella, Toxoplasma, Listeria, norovirus, and Campylobacter—account for 88% of the deaths for which the cause is known.

We watched from the sidelines when major retailers faced public scrutiny over their practices on safeguarding consumer credit card information when their websites were hacked. Today, consumer and regulatory interest in food safety are the new focus areas for the news media, especially in light of the Blue Bell Creameries Listeria and the Peanut Corporation of America (PCA) Salmonella outbreaks. Unlike consumer credit information, serious missteps in our industry can kill people, and in the case of PCA, can put you permanently out of business.

In 2008, peanut butter paste manufactured by PCA killed nine people and sickened 714 others, some critically, across 46 states and was one of the largest food recalls in American history, according to the CDC. Although still under appeal, PCA CEO Stewart Parnell was convicted and sentenced to a 28-year prison term for his role in knowingly shipping out salmonella-contaminated peanut butter. Parnell received one of the toughest punishments in U.S. history in a foodborne illness case.

In the Blue Bell case, a total of 10 people with Listeriosis related to this outbreak were reported from four states, with three deaths reported from Kansas, according to the CDC. Blue Bell pulled their products from store shelves on April 20, 2015. On May 7, the FDA released findings from inspections at the Blue Bell production facilities in Brenham, Texas, Broken Arrow, Oklahoma and Sylacauga, Alabama. The FDA reports highlighted serious problems across multiple sites.

Both cases shine a spotlight on what can happen if you don’t have an effective food safety management system (FSMS). So what makes up a good FSMS, and is it enough to keep you out of trouble? An effective FSMS is built on three elements: Good Manufacturing Practices (GMPs), Hazard Analysis Critical Control Points (HACCP) and a management system. Food safety issues are avoidable, and good processes and a strong culture within an organization make them more unlikely to occur.

Does your leadership  recognize the importance of your FSMS?
Does your leadership recognize the importance of your FSMS? An effective FSMS should be established before a product incident or recall occurs.

Implementing a FSMS does not happen in a few months; it may take up to two years to establish one. No doubt, foundational activities need to be in place for factory operations. In addition to focusing on foundational elements such as making sure equipment is cleaned properly and procedures for allergens are implemented, the leadership team needs to make it clear that it is never acceptable under any circumstances to take shortcuts that could jeopardize food safety. This policy needs to be indoctrinated throughout the organization and thus does not happen overnight.

Underlying an effective FSMS are strong HACCP and GMPs, but food safety should always be the top priority for management and its employees, not share price, earnings or profit margin. Although financial performance is important, food safety must take precedence in the organization, and leadership at all levels needs to send that message loud and clear to all employees. In today’s environment, HACCP is pretty much mandatory from a regulatory standpoint and is an essential part of a FSMS. But the missing piece in many organizations is the support from the top—this is where culture becomes embedded in the organization.

The FSMS culture is the collective behavior from the organization around shared values and beliefs. The organization will follow the actions of leaders, not necessarily what they say—we all know actions speak louder than words. A good food safety culture is one where best practices are openly discussed, defined and rewarded. Food safety culture has become a buzz word and there needs to be a focus on making it come to life through a structured FSMS.

At this year’s Food Safety Consortium conference, Tim Ahn will discuss advancing food safety training and harmonization (November 19). LEARN MOREFood safety training is important not only for first line supervisors and operators, but also for senior managers and leadership, because they define the objectives and policies of the FSMS. What does it mean to conduct an effective management review? What does it mean to do an internal audit? What’s a good corrective action process? Training often misses the mark, because organizations fail to embed it correctly.

For FSMS to thrive, management must commit to the FSMS being a required way of doing things throughout the entire organization. A FSMS is most effective when it benchmarked against a proven standard and verified by an independent third party. Certification against a proven standard will reduce risk within your business.

Select your independent third-party verifier carefully. Do they have the resources and time, and do they know what they are doing? Do they add value to your organization? This is important since once you get certified, your journey starts and it doesn’t end. The value comes in two areas: Identifying risks and developing the appropriate control measures, and ensuring that the process drive continuous improvement in your organization. FSMS is focused on how continuous improvement applies to the management of risk and business operations.

The most effective way to establish an FSMS is to have leadership that recognizes its importance. The worst way is to have a recall or an incident, which draws attention to the fact that there is a problem and something needs to happen. In the case of Blue Bell, they probably understood the importance of food safety and thought they were taking the right actions. However, their management system led them to problems. FSMS must be independently verified against world-class standards to ensure effective performance.

Auditing and FSMS
A thorough auditor won’t look the other way and will find the problems. Call it as you see it–don’t be too soft when getting an assessment.

Companies can develop blind spots where they cannot see their own bad practices, and they become institutionalized over time. Fortunately, experienced independent third-party assessors can shine a spotlight on those bad practices. That is the true value in bringing in outsiders to look at your operations and culture to uncover those blind spots.

At PCA, their poor culture and actions to the problem sealed their fate. In some ways, this criminal case presented a wake-up call to boardrooms across America and highlights how badly leadership mismanaged matters. This case came to light in the context of the public complaining to the regulators that they were not doing enough following several highly visible food poisoning cases. A FSMS would have prevented these problems because the structure would not allow such bad decisions to be made and would have been verified by an independent third party that would test and check everything. A reputable third-party verifier would not miss poor GMP/ HACCP processes.

A good assessor can help a company understand what is really important and what is not so important when it comes to findings (i.e., context). We don’t waste a client’s time with insignificant issues and that is where the experience and judgment of the auditor becomes critical. Last year I met with a client and said, “you need to be checking for Salmonella in your environment—how do you know it is not there?” I pushed them into checking because I understood the changing regulatory environment. I came back a year later, and they had confirmed that regulators were interested in their Salmonella monitoring program during a recent inspection. As an auditor, you have to be confident enough to provide advice and context to the client in a way that is understood and accepted, and that helps to build trust.

With FSMA, the government can now take specific actions against companies. If I am plant manager or CEO, how do I know for sure that I am in compliance with the requirements? How do I know that I don’t have any of these potential issues? The only way to know for sure is to have the FSMS assessed. Just like a bank or publicly traded company hires financial auditors to assure everything is done correctly, companies need to audit their FSMS to ensure compliance. Get a process audit and ensure they drill down deep into the organization—that is where we find issues and gaps. A thorough auditor will find your problems instead of looking the other way. It is important to call it the way you see it and not be too “soft” when getting an assessment.

If I am the CEO, I want to know where those problems exist. Independent third party assurance is the best way to find out how compliant you are with regulations. No CEO wants to deal with the inevitable lawsuits and lost business impacts. At least with an effective FSMS, you can show a level of due diligence when the regulators show up at your doorstep and the culture is such that you want to address any problems.

We have entered an important time for the food industry with FSMA implementation and other food safety regulatory requirements in the United States. These new rules place an emphasis on management accountability, risk assessment and control of supply chains. The bar for due diligence has been raised and it up to all us to show that we have done everything possible, and the best way is with an effective FSMS.

Jim Lassiter, president and COO of Ingredient Identity

Will FSMA Push Ingredients into a New Era of Scrutiny?

By Maria Fontanazza
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Jim Lassiter, president and COO of Ingredient Identity

In June FDA officially deemed the use of partially hydrogenated oils (PHOs) as unsafe, or technically, not generally recognized as safe (GRAS). The use of PHOs has been debated for more than a decade, and as a result of FDA’s latest ruling on PHOs, food processors must remove these ingredients from their products within three years.

From preservatives to artificial sweeteners to natural flavors, the list of ingredients that go into processed foods can be quite extensive. Consumers are becoming more vigilant about what they put into their bodies, and FSMA will give FDA the authority to act immediately in instances related to safety. Does this mean that some ingredients could be in danger? The answer is yes, according to Jim Lassiter, president and COO of Ingredient Identity.  “[Ingredients] are products that you literally take inside your body, and there is nothing more personal than that,” says Lassiter. Combine this simple yet fundamental fact with consumer awareness and the entrance of FSMA, and food and beverage manufacturers may be entering a new era of scrutiny.

Food Safety Tech: From an ingredients perspective, what challenges are the industry facing?

Jim Lassiter: Implementation of FSMA. Although it’s being implemented at a slower pace than Congress desired, and I believe slower than [FDA’s] original intent, that pace is accelerating. And while the increase in challenges related to the composition and manufacturing of products will be significant, FSMA will be an overall benefit to consumer confidence.

Consumer confidence. Whether the issue is bioengineered foods or disclosure of bioengineered foods through the business of trans fats, or just the general composition and healthful nature of foods. Slowly but surely, increasing consumer awareness of food choices and diet will have a significant impact. Regardless of the type of product, this is going to be universal and will increasingly play a role in decisions that food companies make during product development.

The unknowns. We don’t know what is coming around the corner, whether it’s positive or negative. A lot of effort is being extended within the food sector to discover the next big thing—whether it’s probiotics or prebiotics; addressing product reformulation in light of the elimination of trans fat [requirement]; or something that strikes out of the blue. That is always the most challenging aspect of the ingredients industry. Foods themselves, regardless of what country you are in, are cultural in nature; they are the most personal consumer good that you can obtain. As a result, our awareness as an industry of what we do to products must bear both of those pieces in mind. We have to recognize the cultural nature of food and simultaneously recognize the personal nature of products. As a result, we won’t necessarily have insights into the great unknown or the next big thing, but at least we will have the perspective necessary to deal with any unknowns as we move forward.

FST: In the coming year, what overall effect will FSMA have on food and beverage manufacturers related to ingredients themselves?

Lassiter: From an ingredients perspective, what’s going to happen is simple and straightforward. FSMA grants FDA the broad authority to assist and act in instances where there are issues with safety. That is, however, still nebulously defined and interpreted. So, there’s potential for FDA to suddenly make a determination that an ingredient is not safe or [that it] poses some degree of safety risk. FSMA authorizes FDA to take immediate action rather than [submit] a new process notification, etc. They will also have the authority to take immediate action in the case of violations of good manufacturing practices if the perception can be tied to any aspect of safety. FSMA stands for safety; that is the hinge point on which all of this occurs.

For example, with the revised good manufacturing practice for the manufacturing of food products coming out and the full implementation of HACCP across all food categories, it’s conceivable that FDA will take immediate action on inspection deficiencies in the food manufacturing realm. I think that’s one of the big issues. I don’t want to make it sound like the boogey man is out there, but it is a very real possibility. Ingredients themselves can suddenly be identified as unsafe. I don’t see that necessarily being a very radical reaction. The potential impact is more likely to be broad, but I suspect that at some point in time, there will be an ingredient that pops up out of a FSMA ruling that will suddenly be declared to be unsafe and [consequently] removed from market.

Second, I think the implementation of HACCP across all food categories will have notable impact, initially through common regulatory action (i.e., via inspection deficiencies reports, which are very common in terms of dietary supplement manufacturer inspections). I think you’ll see those becoming increasingly common in food manufacturing operations, because of the implementation of HACCP more broadly. The first round will be more likely for increased regulatory activity in food manufacturing inspections. If that message is not received and implemented rapidly, then the extension of FSMA is that [FDA] can shut down the plant without any due process whatsoever. That looms as part of the implementation. In terms of ingredients, you’re likely to see [some] that folks may not have previously thought about [as unsafe] identified as potentially hazardous. I’m not sure in what area it will occur, but I’m fairly confident that it will happen at some point in time.  

Part II of Food Safety Tech’s conversation with Jim Lassiter takes a closer look at GRAS self declarations and the areas of confusion among companies.

Developing an Effective Environmental Monitoring, Sampling and Testing Program

By Food Safety Tech Staff
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As the food industry is moving toward a more preventive food safety strategy, environmental monitoring is playing an increasingly critical role in testing. Hazard analysis is shifting the focus from finished product testing to proactively testing the environment and the processing as critical control points to continuously monitor and reduce risk. Today many facilities are adding or strengthening their environmental monitoring programs to enhance their food safety risk reduction efforts.

In a recent webinar, Ann Draughon, Emeritus Professor of Food Microbiology and Toxicology, University of Tennessee spoke about Developing an Effective Environmental Monitoring, Sampling and Testing (EMS) Program. We present some excerpts from her presentation.

What do you need to get started with an EMS program?

“You need to first identify the right team; think about what kind of food you are processing (raw products or ready-to-eat products) and if it has had any food safety outbreak associated with it; determine critical or hygiene zones in your facility; determine sample locations; finalize which indicator tests will be done, and in which zones; determine which pathogens you will test for; choose the right test methods; set a baseline, and link that with your sampling plan, and establish testing frequency once you have finalized the number of samples and zones,” explains Draughon.

To establish critical hygiene zones, she advises to:

  • Survey entire facility and have a map of that facility;
  • Study that map and identify traffic patterns to divide the facility into critical hygiene zones, GMP zones, and non-processing zones;
  • Put in place barriers between these zones and dedicate equipment to the critical hygiene zone, and restrict access between zones; and
  • Establish strict cleaning, sanitation and monitoring plans for these diff zones.

Sampling of zones should be based on risk of contamination and/ or transmission of pathogens to food from environment, says Draughon. The sampling should also take into account potential sources of product contamination by whatever means during food processing (see image 1 for examples of 4 zone and 3-zone hygiene systems).

Selecting the right assays for your EMS program

There are many options, and it can be confusing to select the right assay for your needs. Draughon advises that companies need to look their monitoring needs and consider both indicator bacteria and pathogenic bacteria to select the right assay.

For monitoring with indicator bacteria, most companies look at ATP for environmental sanitation, often before start-up to make sure facility is clean before processing begins. Protein assays are also used to pick up any allergen on equipment.

APC or total viable count is a simple assay offering many choices, which tests for the number of live bacteria on your equipment or in your environment that can grow under air or oxygen at room temperature.

Yeast/ mold count assays are good for two purposes: 1. Mold frequently is the cause of spoilage in food, so it’s useful to understand if there are any present to determine shelf life, and 2. It also helps us understand the number of particulates in the air.

We can also select specific microbial groups as indicators, such as total Enterobacteriacae, fecal coliform or E.coli or Listeria species.

Sample collection and prep

When we collect a sample, we have to clearly document the sample including information such as when it was taken, from where, by whom, what happened to that sample etc. Use clean SOPs to reduce error. Use the assays previously selected and do it as quickly as feasible. If you are working with an outside company, decide how they are going to handle the sample. Finally, always keep in mind plant safety and leave nothing behind after sampling, and avoid cross-contamination.

For characterizing pathogens, you may want to genetically fingerprint any pathogenic isolates from your facilities. This will allow you to see if you have a constant harborage of a particular pathogen or if it changes. Draughon recommends using a contract lab for characterizing pathogens, as they would be better suited, and have better resources to do this. Destroy the isolates after characterization – you don’t want any chance of the pathogen spreading into the product or the environment.

Written SOPs for EMS programs

It’s critical to have clear written SOPs for EMS programs which include the following:

  • Frequency of sampling;
  • When, where , how and duration of sampling;
  • Procedure for recording data and coding;
  • Sample number, size or volume;
  • Specific sampling and analysis validated protocols;
  • Monitoring of incubators and use of equipment;
  • Handling and shipping of samples; and
  • Alert and action levels and appropriate response to deviations from alert or action levels.

It’s also important that we train and validate the personnel performing EMS. Each individual doing this needs to demonstrate proficiency of doing this. They need to understand proper recording of EMS program data, alert and action levels, and zero tolerance levels. The personnel should be comfortable and qualified for sampling protocol, and using all the equipment.

In summary, sampling plans should be adaptable, which highest risk sites being tested initially. Establish a baseline and modify sampling plan as needed. Establish your sampling and testing criteria and sample as needed with each zone to fully assess the environmental program.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Pet Food Safety: Regulations and Challenges

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

Alan Baumfalk is Pet Food Safety Specialist and food safety Auditor at Eurofins US Foods Division. After more than three decades of experience in human food production facilities, Baumfalk began inspecting and auditing pet food companies with a fresh pair of eyes and in his opinion, “pet food plants typically are very well maintained, embrace technology, are highly automated, have great productivity and are very efficient with their sanitation and production.”

In an interview with Food Safety Tech, Baumfalk talks about differences in production of human food and pet food; lessons learned from historical incidents such as melamine in pet food and contaminated chicken jerky; what are some gaps in pet food safety he’s noticing and impact of the Food Safety Modernization Act or FSMA on this sector.

Food Safety Tech (FST): What are the differences between the production of human food and pet food?
Baumfalk: In most cases, pet food facilities are dry facilities, making kibbles and similar products, and their cleaning sanitation processes are mostly sweeping and dusting, with very little water involved. When it comes to regulations covering pet food facilities, most of these fall under FDA jurisdiction, and pet food facilities need to have in place risk-based HACCP plans to ensure food safety. Some of the challenges involved in pet foods are how do you do sensory testing on dry pet food or test for taste or consistency? Pet food testers look at certain quality attributes such as color, look, smell and taste of the product. They look for data such as amount of protein in the food etc. They also need to consider if humans – especially the elderly, or children – would consume the pet food product, because this can have many food safety implications.

FST: Humans have allergic reactions to certain food ingredients. Do pets have similar concerns of allergens?
Baumfalk: We don’t know if pets suffer allergic reactions to any specific food ingredients similar to humans. Pet food manufacturers are not subject to allergens and are exempt under FDA’s allergen management regulations. However, there are strict GMPs maintained in pet food production facilities, so that known allergens are identified. Pet food manufacturers give attention to allergens though they are exempt because it’s possible that the allergens could get transferred to a human in the house who could be allergic to nuts or soy, and this could be a huge problem. In our experience, we have seen that pet food can be occasionally consumed by a child or an elderly pet owner, out of curiosity.

FST: How about pathogens such as Salmonella and E.coli, are pets susceptible to these?
Baumfalk: Pets are not typically affected by pathogens such as Salmonella or E.coli, and this goes back to their genetic background, which is, dogs coming from wolves, and cats from tigers and lions. These animals are used to eating things with pathogens, fecal matter etc. However, humans are at risk of infection by Salmonella and E.coli, so while the end consumer of pet foods are not affected by these pathogens, their handlers are. Hence, pet foods are tested for Salmonella and E.coli to make sure they are pathogen free. They have Critical Control Points (CCPs) and kill-steps just like human foods, and pet foods are diligently sampled before they are released in the market. Environmental monitoring is also strictly carried out – such as extensive swabbing of processing floor, walls etc. to test for Salmonella/ E.coli/ mycotoxins etc. If a raw material exceeds FDA guidance for mycotoxins, then they are rejected. Many manufacturers test for mycotoxin levels in finished product as well.

FST: Are there differences in auditing pet food companies versus human food manufacturers?
Baumfalk: All pet food companies are looking to get certified and audited under a GFSI-recognized scheme. SQF is probably the biggest standard though some choose BRC. Eurofins has close ties with the American Feed industry Association (AFIA) which recommends SQF, and so we follow the same standard when auditing pet food facilities. SQF has modules specific to pet food category and dry pet food products. There are a lot of similarities with requirements for human food – for instance, pest control within a pet food plant is the same as within a human plant. The commitment and requirement for compliance is the same.

FST: What are some gaps or challenges in pet food safety?
Baumfalk: Most of the folks working in the pet food industry have a background in human food and are very much aware of the technical and regulatory requirements for making human food, so they end up carrying it over to pet food production. They typically follow GMPs and HACCP, and safety plans to ensure there are no food safety gaps. While most pet food companies meet, or even exceed, compliance requirements, there are always some people in the industry that don’t get the message.

FST: When we think about pet food safety, the history of melamine contamination of pet food, and tainted chicken jerky from China come to mind. What are lessons learned and how can the pet food industry be prepared for the unknown?
Baumfalk: The melamine adulteration and chicken jerky contamination incidents have taught the industry to be on guard. The industry has to make sure that they are in close alignment with their industry association which speaks for them, read technical documents, hire and train knowledgeable staff – all of which helps constantly look for the next thing that we weren’t aware of. Apart from diligently monitoring the global supply chain, it would help to have strict audit specifications for global suppliers. If something is coming from the other part of the world, where there’s a history of food safety standards not always being up to par, the pet food industry needs to make sure to buy only from a known and approved entity. Also look for lessons that can be learned from the human foods industry. Read about recalls and withdrawals and find out why that happened, if the pet food industry has similar exposure, and how this can be addressed.

FST: What will be the impact of the proposed pet food safety rule under FSMA be on this industry?
Baumfalk: FSMA is going to tighten things up, paying a lot of attention to the global supply chain and any vulnerabilities. While regulations are still being finalized, the pet food industry is already aligning itself with these proposed regulations. The technical and regulatory folks in the industry are following it; they are reading food safety journals and interacting with their associations for guidance and for making comments on the regulations. We are also updating our auditing checklists to see how we can align better with new FSMA requirements.

For more information on Eurofins, it’s pet food and auditing capabilities, click here.

5 Tips for Conducting a Successful Internal Audit

By Michael Biros
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A strong internal audit program will help drive continuous improvement, promote a food safety culture within the organization, and help improve the external audit score.

Beyond achieving compliance with the SQF program requirements, internal audits help drive continuous improvement and can facilitate a food safety culture throughout all levels of an organization. Gary Smith, Senior Technical Director at SAI Global, discusses 5 key factors to successfully conducting an internal audit.

What is the SQF Standard: Item 2.5.7 Internal Audit?

This requirement includes methods and responsibilities for scheduling and conducting internal audits to verify the effectiveness of the SQF system including facility and equipment inspections, PRPs, food safety plans, food quality plans, and regulation controls. Companies must have an internal audit schedule with scope and frequency and records of internal audits, corrections, and corrective actions. The internal audit must be conducted by staff trained in internal audit procedures and the audit results must be communicated to relevant management.

In the SQF program, a major nonconformance indicates a systematic failure where an element is failing or not existing. Some common major nonconformances include not having a schedule of internal audits, having verification and validation activities defined but not having an internal audit program, not having a facilitator for an internal audit program assigned, and having the internal audit only cover GMPs, but not the SQF system. Some of the minor nonconformances include not having an internal auditor training for the lead auditor, not defining how results are to be communicated to leadership, not taking corrective actions for internal audits, or not having records of corrective actions.

5 Keys to Success

  1. Reach out to leadership. Work with your leadership to define objectives of the internal audit program with management to facilitate management commitment. Build the internal audit program with management objectives. Remember, it’s not the QA’s program certification, it’s the entire company’s.
  2. Formalize the audit process. Set an audit schedule and keep to it. Assign an audit team with responsibilities. Use an audit checklist. Develop an audit plan. Conduct interviews during the audit. Conduct opening and closing meetings with staff.
  3. Communicate well. Regularly provide updates to leadership at routine meetings. Provide the audit plan and checklist to auditees one week prior to the audit. Take photos of good practices and nonconformances. Provide the audit results in a timely manner.
  4. Manage internal audits as its own program. Have standard operating procedures describing the responsibilities and procedures. Have the facilitator be trained as a lead auditor and appropriate training for all team members. Include as many people as possible in the audit team from all departments within the company.
  5. Use corrective action management program for all internal audit findings. Keep an internal log of all your internal nonconformances. Use root cause analysis to understand why nonconformances occur and include internal audit findings, regulatory audit findings, nonconforming products, and customer complaints in the corrective action management plan.

A strong internal audit program will help drive continuous improvement. It will help promote ownership of the entire SQF system and promote a food safety culture within the organization. Lastly, a strong internal audit program can improve the external audit score.

For more information, see this archived webinar: SQF 5 Tips for Conducting a Successful Internal Audit