Economically motivated adulteration (EMA) has considerable economic ramifications, impacting businesses from a financial and liability perspective, posing dangers to consumers, and eroding product confidence. One of the biggest issues with monitoring the volume and type of adulterated products is the fact that the landscape of food fraud is ever changing. “The perpetrators are always two steps ahead, so innovation is needed to keep up,” said Jeff Moore, Ph.D., director of science, food program at U.S. Pharmacopeial Convention (USP), at the GMA Science Forum last week.
GMA and Battelle have teamed up to launch EMAlert, a tool that companies can use to quantitatively assess the vulnerability of their supply chains to EMA. The secure, cloud-based platform comes with 50 commodities off the shelf (including spices, grains, dairy, seafood, meat, oils, fruits, veggies, and food ingredients). It was developed fairly rapidly (Battelle, which serves as the technology provider, started development at the beginning of this year) and still needs to be validated; full validation will be presented at the IAFP meeting this summer. And if EMAlert lives up to its potential, it could help companies be more nimble in monitoring and acting on threats in their supply chain.
The purpose of the tool is to generate quantitative vulnerability results that allow people to make actionable decisions based on numeric values. As such, it has been designed to be dynamic and customizable, since every company has its own risk tolerance. In addition, it looks at real-time environmental changes, because you can’t have a static tool to monitor vulnerability when it’s always changing, said Joseph A. Scimeca, Ph.D., vice president, global regulatory & scientific affairs at Cargill, Inc.
A screenshot of EMAlert
“The EMA threat is changing,” said Ashley Kubatko, principal research scientist at the Battelle Memorial Institute. “A static assessment is only a snapshot in time.” EMAlert pulls live, automated data that takes into account economic drivers (value, volume, and scarcity of product), historical drivers (how often has product adulteration occurred in the past, geopolitical stability), and ease drivers (how frequently the commodity is tested; whether there are government regulations around the commodity group; how often the product changes hands or is repackaged). Data is pulled from several databases, including FDA, UN Comtrade, USP, Quandi, and Transparency International.
When creating the tool Battelle borrowed from its approach in working with the U.S. Department of Homeland Security to develop models that predict terrorist decision making and used the same mathematical methodology, providing a predictive model of fraudster behavior. Keeping in mind that perpetrators are also constantly monitoring how law enforcement and industry is keeping track of their strategies, EMAlert not only requires a subscription, but Kubatko says that Battelle will also be monitoring its users to ensure there is no suspicious activity within EMAlert.
Retail food establishments face many challenges, and employee retention is one of the major concerns. Employee retention affects scheduling, hiring, and the overall effectiveness of training. Food safety training usually suffers when turnover occurs.
The safety of customers is dependent on an employee’s knowledge and execution of the food safety standards that are in place.
The biggest challenge in training in the retail/hospitality industry is the risk that the employee may leave within the first year (or less) of employment. According to Restaurant.org, the average turnover rate for the restaurant/hospitality sector was 66.3% in 2014.1 This turnover rate creates a challenge for maintaining a solid food safety culture.
Restaurants can take proactive steps to create and maintain a food safety culture that is always visible to new and current employees by adopting various techniques.
Signage Is Your Friend
Signage throughout your restaurant is a great way to continuously relay a food safety message without confining employees to a computer or module-based system. This signage should be simple, sometimes playful and right to the point. An employee or manager takes roughly 30 seconds, on average, to read a message, so the shorter the better.
Visual signage is always a great tool to use in the back of house to relay food safety standards (e.g., proper cooking temperatures, order of storing food in coolers, etc.). Signage (photos specifically) may also assist employees who may not communicate in English proficiently. A picture is worth a thousand words, so utilize photos, cartoons or captions in order to relay the message.
Target the Leader
A quality assurance/food safety team should focus its training on the leaders of a region and/or district. Managers have more incentive to stay with companies longer; therefore, food safety training will be retained for a longer period. They may also visit their locations more frequently than the food safety professional, which gives them additional contact with the restaurant-level staff.
To assist these managers in their communication and verification of standards, compose a customized checklist for them to complete during a restaurant visit. The checklist should fulfill the following:
Highlight the top opportunities they seek out (hand washing, sanitizer concentration, etc.)
Provide the proper corrective action to eliminate the opportunities
Considers their time. A manager does not have the ability to complete a five-page checklist. Keep it simple—just the facts!
If these managers are well versed on food safety and sanitation and procedures, they will be able to hold their restaurants to a higher level of compliance. So provide them with all of the tools they need to communicate to their employees.
Informed Employees Are Powerful Employees
Creating newsletters or publications serve as a great tool to keep employees informed of food safety policies. These articles can highlight trends in your company and new products available for use (i.e., chemicals, thermometers, etc.).
By law, every restaurant must have an area where employee information is listed (minimum wage, disability rights, etc.). This board is the perfect place to post your publication.
In conclusion, keeping employees trained on proper food safety standards is the best way to ensure your customers are safe and your brand is protected. Implementing various forms of communication of these standards will create a strong foundation for an excellent food safety culture to exist.
Since 2002, the amount of FDA-regulated food imported to the United States has nearly doubled. With the implementation of FSMA well underway, expect that FDA will be increasing its inspections at foreign manufacturing facilities. When prioritizing inspections, FDA looks at a facility’s compliance history, the risk of the product manufactured in the plant, the date of its last inspection, and any import alerts associated with the site.
First and foremost, it’s important to make sure your foreign facility understands what a food safety plan under FSMA requires, said Chengboey Lau, principal scientist for North America scientific & regulatory affairs at Mondelēz International. Today at the GMA Science Forum Lau pulled from the experience of Mondelez (the $30 billion-company has more than 165 manufacturing plants worldwide and requires all of its suppliers to be GFSI certified) to provide some helpful tips on how a company can get ready for an FDA inspection of a foreign facility, what it should do during the event, and the steps that should be taken afterwards.
Prepare for the Inspection
Develop an internal policy for foreign inspections
To ensure readiness at all times, implement a proactive program that involves the following activities
Annual review of registered facilities
Review of any products or materials made for U.S. markets (including R&D samples)
Gap assessments to ensure compliance with FDA requirements, followed by an action plan to close identified gaps
Employee training on FDA requirements
Create a site-specific FDA inspection manual for all necessary documentation
Survive the Inspection
Align expectations with the inspector at the start of the inspection
Have an employee who has strong English skills present to help with translation (the employee should have an understanding of American slang, too)
Consider having a U.S. regulatory support colleague available for questions during the inspection
Post-inspection
Email the inspector or make a Freedom of Information Act request if you don’t receive an establishment inspection report after six months
If a form 483 letter is issued, respond in writing within 15 days, and follow up within 40 days to inform FDA of the completion of any corrective actions
At the end of the day, make sure you have a firm understanding of which final FSMA rules apply to your organization, advised Lau. From there companies should perform a gap analysis, identify the resources necessary and any constraints involved, train employees on the new FSMA expectations, and be prepared to implement new and/or modify current policies and procedures to ensure inspection readiness.
FDA intends to pursue criminal investigations against any food company executives or quality assurance (QA) managers involved in cases in which a link is made between a positive sample collected by the agency from a food facility or product and a foodborne illness.
In fact, the agency and the U.S. Department of Justice just announced that they will be working together to aggressively enforce food safety laws, including the Food, Drug and Cosmetic Act. In prepared remarks at a food safety conference last week, Benjamin C. Mizer, principal deputy assistant attorney, indicated that criminal prosecution of food companies is a priority moving forward. “When it comes to food safety, we have to rely on the companies who manufacture and distribute food to ensure that the food we buy is safe,” Mizer stated in his remarks. “That is why food safety is a priority for the Justice Department. Our role in protecting consumer safety is at its apex when consumers can least protect themselves.”
In addition, the FDA is exercising nearly limitless authority to access company records during an inspection and investigation—and in many cases doing so without a warrant.
The Park Doctrine. In 1975, the Park Doctrine solidified FDA’s authority to criminally charge corporate executives and high-level managers. The Supreme Court upheld the conviction of the president of a major grocery chain who was found to be criminally liable for unsanitary conditions existing in a company distribution center, notwithstanding the argument that he had delegated the responsibility for maintaining the cleanliness of the site to his subordinates. The Supreme Court concluded that if a company ships adulterated food, the management of that company can be charged, even if they have no direct knowledge or intent. Under this standard, a food industry executive or QA manager can be sentenced to prison if he or she is aware of a circumstance or condition within his or her facility that could lead to a foodborne illness and fails to take action to correct it. If charged with this type of misdemeanor, the executive could be sentenced to up to a year in prison and a $250,000 fine for each count. On a case-by-case basis, FDA will consider the individual’s position within the company, his or her relationship to the violation, and whether in fact he or she was in a position (or had the authority) to correct the violation. The government is demonstrating that it intends to use criminal sanctions to create a deterrent and compel compliance.
Peanut Corporation of America (PCA): Salmonella outbreak (2008). PCA owner Stewart Parnell was sentenced to 28 years in prison for knowingly selling peanut products contaminated with Salmonella. His brother, a peanut broker, was sentenced to 20 years, and Parnell’s QA manager was sentenced to five years.
Quality Egg: Salmonella outbreak (2010). Quality Egg distributed products linked to a Salmonella outbreak that sickened more than 1,000 people. Company executives did not know that their products were sickening consumers but were nevertheless cited by FDA for failing to control Salmonella in the growing and processing environment. When the outbreak was over, FDA conducted a criminal investigation, and company executives were sentenced to three months in jail and slapped with significant fines for food safety violations.
Learn new and innovative approaches to Listeria detection & control at Food Safety Tech’s workshop | May 31–June 1, 2016 | St. Paul, MN | LEARN MOREJensen Farms: Listeria monocytogenes (2011). The company distributed cantaloupe contaminated with Listeria monocytogenes and, over a two-month period, the tainted product sickened nearly 150 people and killed more than 30. Company owners were unaware of product contamination, but federal prosecutors brought criminal charges against the company regardless, arguing that Jensen Farms failed to take appropriate steps to reduce Listeria contamination in its facility. Company owners were sentenced to five years’ probation, six months’ home detention, 100 hours of community service, and assessed individual fines of $150,000.
ConAgra: Salmonella (2006–2007). In 2014 FDA urged criminal charges be brought against ConAgra for distributing Salmonella-contaminated peanut butter, which sickened about 700 people, between 2006 and 2007. The company pled guilty to the charges and paid more than $11 million infines.
On May 2, 2014 FDA announced its intent to pursue “[c]riminal prosecution for falsifying records, lying to FDA, knowingly putting consumers at risk, or in other appropriate cases.”
Blue Bell: Listeria monocytogenes (2010–2015). In 2015, Blue Bell Creameries was linked to an outbreak in which FDA connected positive samples from those taken at retail and those taken at production facilities to seven case patients in the CDC database who carried the same strain of Listeria. Last year the agency urged the company to recall all of its products. What’s most concerning about the investigation is the fact that the first people who became sick fell ill more than five years ago (January 2010); two more illnesses were recorded in 2011, followed by one in 2012, and three in 2014. The final illness was reported January 2015.
The U.S. Department of Justice (DOJ) confirmed that FDA and the DOJ are making criminal sanctions “a priority” when companies “fail to live up to their obligations to protect the safety of the food that all of us eat.” The DOJ, working with FDA, has served federal grand jury subpoenas to Blue Bell, and is likely scanning food company records and executive emails to justify any criminal charges. If criminal charges are indeed brought against Blue Bell, FDA will likely argue that the company was periodically finding LM in its facilities over the past five years and failed to take sufficient action to correct the condition, which (as proven by the seven matching cases in PulseNet ), resulted in human illness. Although this seems like an extreme approach, given the ubiquitous nature of LM, it is the approach the agency is aggressively pursuing.
Chipotle Mexican Grill: Norovirus (2015). For several months last year, Chipotle was unable to contain and manage numerous foodborne illness outbreaks. In a public filing the national restaurant chain confirmed that it received a federal grand jury subpoena from the DOJ in connection with a norovirus outbreak that occurred at a location in which more than 200 customers became ill.
According to reports, Chipotle executives became aware that numerous employees had reported being sick in August 2015, yet they waited a few days before informing the local health department of the illnesses and closing the restaurant. In turn, it appears that FDA and the DOJ initiated a criminal investigation and served the grand jury subpoenas in order to gain access to corporate emails and determine whether company executives waited “too long” after learning about the illnesses to take action. On January 28, officials from Chipotle confirmed that the restaurant chain was served with a subpoena that broadened the scope of the initial criminal investigation by the U.S. Attorney’s office for the Central District of California. This subpoena requires Chipotle to produce documents and information related to company-wide food safety matters dating back to January 1, 2013, and supersedes the subpoena served in December 2015 that was limited to a restaurant in Simi Valley, California. Although FDA is trying to uncover how the recent outbreaks occurred, the agency is also engaging in a broader “fishing expedition” to determine whether there is further justification to bring criminal sanctions as a result of any of the company’s broader food safety conduct.
Multiple Non-public Cases
The DOJ, in cooperation with FDA, is currently pursuing criminal investigations against many other companies connected to other reported illnesses. As these are ongoing investigations, the underlying facts cannot be disclosed publicly. However, the most important lesson to be learned is that food companies must be prepared to better control pathogens in their environment in order to protect themselves from criminal prosecutions. My subsequent column will discuss these strategies.
In remarks made at the Consumer Federation of America’s annual food policy conference this week, Benjamin C. Mizer, principal deputy assistant attorney general, stated that the federal government has made consumer safety a top priority. With this announcement comes an announced intention on the part of the U.S. Department of Justice (DOJ) to use “various enforcement tools that we have at our disposal,” and maintain a stronger partnership with FDA to go after companies that “introduce adulterated foods into interstate commerce”.
“In deciding whether to use our civil or our criminal enforcement tools, the Justice Department follows the same set of guidelines that apply to every criminal prosecution,” said Mizer. “Among other things, prosecutors evaluate the nature and seriousness of the offense, the deterrent effect of the prosecution and the culpability of the individuals or entities involved.” Criminal charges brought against a food company can be either misdemeanor or felony, and Mizer emphasized that misdemeanor violations can still result in “serious penalties”. He cited a case in which the owner and CEO of an egg production company in Iowa pled guilty to a misdemeanor and received three months in jail and one year supervised release, and was slapped with a $100,000 fine.
“In some cases, the facts are so egregious that it is appropriate for the Justice Department to bring the full force of the law to bear,” stated Mizer. “When we can show an intent to defraud or to mislead consumers or the FDA, a defendant can face felony charges.” To illustrate this scenario, Mizer referred to the landmark case against the Peanut Corporation of America, which is perhaps the most commonly referenced case in recent months, as many in the industry have voiced their opinion that it has set a precedent as to how the government will handle such situations moving forward.
FDA has finalized the FSMA rule Sanitary Transportation of Human and Animal Food. The rule establishes sanitary requirements for shippers, loaders, motor and rail vehicle carriers, and receivers involved in transporting human and animal food. The rule does not apply to exporters that ship food through the United States.
“Consumers deserve a safe food supply and this final rule will help to ensure that all those involved in the farm-to-fork continuum are doing their part to ensure that the food products that arrive in our grocery stores are safe to eat,” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine in an agency press release.
The sanitary transportation rule puts forth requirements for the following:
Vehicles and transportation equipment, including design and maintenance
Transportation operations, including temperature control, preventing contamination between ready-to-eat food and raw food
Training of carrier personnel
Record maintenance, including written procedures, agreements and training
Those exempt from the rule include:
Food transportation shippers, receivers and carriers with less than $500,000 in annual revenue
Farms that perform transportation
Transport of compressed food gases and food contact substances
Transport of live food animals
Transport of human food byproducts for use as animal food without additional processing
Businesses must comply with the regulation one year following publication; smaller businesses (those with fewer than 500 employees and motor carriers with less than $27.5 million in annual receipts) have two years to comply.
Additional information is available on FDA’s website.
Most recently we have seen an increase in foodborne illness outbreaks from Listeria to Salmonella to Norovirus to E.coli, many of which are a result of post-lethal contamination of processed foods. This is often a direct result of a gap in the sanitation programs that were in place at the processing facilities. Every facility should conduct a sanitation gap analysis on an annual basis. In order to receive unbiased feedback, this activity is best performed by a third party that is not a chemical provider.
Join Gina Kramer at the Listeria Detection & Control Workshop, May 31–June 1 in St. Paul, MN | LEARN MOREDeveloping and implementing a sound environmental hygiene program at a food processing facility is essential to its success in producing safe food for consumer consumption. There are fundamental basics of sanitation that every plant must follow in developing a strong program. The fundamental basics include: Developing sanitation standard operating procedures (SSOPs) for; Floors and drains, walls, ceilings, equipment and utensils, and employees. SSOPs must also contain perimeter control, foot traffic control into food preparation areas, zoning, and environmental sampling procedures.
VIDEO: Jeff Mitchell and Gina Kramer discuss the increase in Listeria recalls. | WATCH NOW
When developing SSOPs, using the proper risk reduction formula will lead to sanitation success. To determine the best risk reduction formula, I sought the advice of sanitation expert, Jeff Mitchell, vice president of food safety at Chemstar. Before working for Chemstar, Mitchell was the Command Food Safety Officer for the United States Department of Defense (DOD). Serving more than 20 years for the DOD has given him the opportunity to visit thousands of processing facilities all over the world, seeing the best and the worst, and assisting in finding the root cause of contamination issues and negative environmental sampling results. In this article, I share Mitchell’s risk reduction formula for sanitation success and how to use the formula to build a solid and successful sanitation program.
Foundational Science
“An understanding of the difference between transient and persistent (or resident) pathogens is a key part in the foundational science of sanitation solutions,” explained Mitchell as we discussed the details of the risk reduction formula. Transient pathogens are those that are introduced to the processing facility from the external environment. Entrance occurs from deliveries on transportation vehicles and pallets, food, and non-food products and its packaging, employees and visitors, pests and rodents, along with leaks in the roof or improper cleaning of drains, which are known reservoirs.
“Persistent pathogens are those pathogens that establish residency within the processing facility. Most bacteria will aggregate within a biofilm, allowing them to live in communities. A biofilm is a survival mode for the bacteria; it protects it from sanitizer penetration. The biofilm layers actually masks it from sampling detection. You could swab a surface or an area and not get a positive pathogen test result, because the biofilm is masking it,” Mitchell stated. He continued to explain that most contamination risks are likely from established populations. Four things need to exist for resident populations to form: Pathogen introduction, water, trace organics and niche area for attachment and growth. Food processing facilities should be most concerned about these populations, as they’re being traced to many recent outbreaks and recalls.
In his experience, Mitchell shared that sanitation efforts should focus on areas within the processing facility where moisture and nutrients are collected; both are needed for biofilm formation. Disruption of these niche areas containing biofilm can result in direct (food contact) and indirect (non-food contact) contamination if the biofilm is not completely penetrated or removed. This can occur through active and passive dispersal of pathogens. Active dispersal refers to mechanisms that are initiated by the bacteria themselves where they naturally eject from the biofilm and land on other surfaces. Passive dispersal refers to biofilm cell detachment that is mediated by external forces that shear the biofilm, causing it to move and further spread. This can be caused through fluid shear, abrasion and/or vibration due to power washing, equipment vibration, or deep cleaning/scrubbing that does not penetrate and remove all the aggregate layers of biofilm. In other words, the biofilm and pathogens are just smeared around the facility like cleaning a mirror with a greasy wiping cloth.
Chemistry and Application
The cleaning matrix must be considered to properly remove soils that house both transient and persistent pathogens. This is done by combining proper cleaning and sanitizing agent concentration (PPM), adequate exposure time, proper temperature and mechanical action (agitation) or good old elbow grease. If there is a decrease in one area of the matrix, then an increase in the other areas needs to be made as an accommodation to the cleaning process. My years working in industry have taught me that the most expensive quadrant of the cleaning matrix is agitation, because it requires manual labor. Reduction of labor is one of the first ways companies build in efficiencies to increase profit margins. That means a solution must be built that focuses on temperature, concentration and proper contact time to produce the sanitation results necessary to prevent persistent pathogens from establishing residency within processing facilities.
Temperature should be regulated by the type of soils that need to be removed. High fat soils need a higher temperature of about 140⁰ F. However, when removing high protein soils, the temperature needs to be reduced so that the protein is not baked onto the surface. Baked proteins that are not removed become nutrients for bacteria to aggregate and reside. High temperature is does not work in every food processing plant, Jeff explained.
Proper balance of detergent and sanitizer is necessary to remove and destroy both transient and persistent pathogens. The detergent needs to be the right formulation and contact time to break down soils and biofilms with application of the right concentration and contact time of sanitizer to kill the exposed pathogens. Without the right balance in place it can create the perfect storm for spread and contamination within the processing facility.
Validation
Do your homework. Research is the most valuable tool when validating the effectiveness of a cleaning process. Private research is good but not the only form of validation on which to base a business decision. I have found that peer reviewed published research is best to use in validating all quadrants of the cleaning matrix. Academic research based on sound science that has practical application results is worth the investment to make sound business decisions.
Many products have been developed to penetrate and destroy the biofilm layers that bacteria aggregate. Again, do your homework. Choose a product that also provides a pathogen kill once the biofilm has been penetrated. I cannot stress enough to make sure that the SSOPs follow the manufacturer’s validated processes and the sanitation team follows the SSOPs’ directions.
Solution
Applying the desired solution requires dividing the processing facility into zones to designate specific sanitation requirements. This will assist in the development of specific SSOPs that apply the right solution in the right zone throughout the site.
Mitchell also gave great advice about cleaning tools and cleaning chemical basics. He explained that a facility should color code the cleaning tools according to zone and only use them in the designated zone area. This prevents cross contamination from occurring, because cleaning tools can be vehicles of contamination transfer. Utilize foam detergents and foam sanitizers as they are more forgiving and increase contact time, and sanitation crew can see where they have applied the chemicals. Use the Ross-Miles foam test for stability: Foam should last more than three minutes before breaking and turning into a liquid solution that runs down the drain, costing a site money and opening up the potential for introducing pathogens into production rooms.
Mitchell advised the development of sanitation procedures that focus on daily thorough cleaning of everything from the knees down in Zones 1-3. “You want to knock everything down and keep it down. The objective is to keep bacterial creep from occurring,” he said. “Creep is where bacteria are moved by processes like water spray, splash and aerosolization, causing the bacteria to move from one area (it usually develops on the floor) to then move up walls and the legs of equipment, etc.— eventually causing contamination of food during food production and packaging.” Obviously, all food contact surfaces in Zone 1 need to have specialized SSOPs according to the equipment, food processing shifts per day, and type of foods that are being processed.
Mitchell stressed that perimeter and foot traffic control entry programs should incorporate a good foam sanitizer that stands up to the Ross-Miles test with optimal duration of five minutes. The distribution of the foam should cover a large enough area that the employees’ foot path and equipment must travel through the foam to achieve contact to control transient pathogen entrance into Zones 1–3. Concentration levels of these areas should be at least double what the food contact area strength is for effectiveness of log kill needed for control.
Environmental monitoring procedures should follow the zoning process set up for sanitation. “Swabbing for Adenosine Triphosphate (ATP) and/or Aerobic plate count (APC) are tools that can be used to help identify biofilm locations. One thing to note is that the bacteria located under the biofilm are in a modified dormant state requiring less energy and making less ATP available for detection. With that said, ATP and APC swabbing are still both viable tools to use in sanitation verification,” said Mitchell. If you only test for general risk pathogens in your facility you may receive false negatives due to biofilm masking the pathogen from showing up as a positive in environmental testing. Utilizing both general pathogen, ATP and APC in concert, is the best combination in a facility’s environmental monitoring program. The goal is to seek and find then destroy and verify.
I recently discovered a great biofilm visual detection test from Realzyme that is wonderful to use to verify whether the sanitation system in place is working. It can also differentiate between protein build-up and biofilm formation. In my professional opinion, this visual detection test is essential to incorporate in a robust environmental testing system.
Safe Food: The End Product
Our responsibility as food safety/quality professionals is to provide the safest, most delicious food for our customers to enjoy. To ensure safe food in our end product, we need to develop a robust sanitation and environmental testing program that follows the risk reduction formula (Foundational Science + Chemistry & Application + Validation = Solution) and conduct an annual sanitation gap analysis by a third-party expert for continuous improvements.
Apply these steps to protect your food, protect your brand and protect your customers so that they Savor Safe Food in every bite!
Food laboratories in the United States may voluntarily choose to become accredited to an international standard known as ISO/IEC 17025:2005. This standard outlines the general requirements for the competence of testing laboratories.
More recently, the FDA issued a final rule on the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Third-Party rule). Effective January 26, 2016, this final rule states that “for a regulatory audit, (when) sampling and analysis is conducted, the accredited third-party certification body must use a laboratory accredited in accordance with ISO/IEC 17025:2005 or another laboratory accreditation standard that provides at least a similar level of assurance in the validity and reliability of sampling methodologies, analytical methodologies, and analytical results.” In short, for a segment of food laboratories, accreditation has become a necessary credential. At present, it remains a voluntary activity for most food laboratories.
There are accreditation bodies that accredit food laboratories to the ISO/IEC 17025 standard. The major accreditation bodies report on their individual websites which U.S. food laboratories are accredited under their watch.
To find the number of accredited laboratories, a quick search of the websites of four major food laboratory accreditation bodies, A2LA (American Association for Laboratory Accreditation), AIHA-LAP (American Industrial Hygiene Association – Laboratory Accreditation Programs, LLC), ANAB (American National Standards Institute-American Society for Quality), and PJLA (Perry Johnson Laboratory Accreditation) was performed on February 24, 2016. It yielded some debatable results. Here are some of the reasons for the skepticism:
The numbers are self-posted to individual websites. The frequency with which these websites are reviewed or updated is unknown.
Sites list both domestic and international laboratories. While foreign addresses were excluded from the count, those laboratories could perform testing for U.S. entities.
It can be difficult to separate the names of laboratories performing testing on human food versus animal feed.
There are several ways to duplicate or even exclude numbers. As examples, laboratories may be accredited within a food testing program, but may also be accredited under “biological” and/or “chemical” schemes—or vice versa.
In some cases, it is difficult to discern from the listings which laboratories are accredited for food testing versus environmental or pharmaceutical testing.
With all these caveats, the four major laboratory accreditation bodies accredit approximately 300 food laboratories. A2LA captures the lion’s share of this overall number with approximately 200 laboratories.
Let’s move to another source of numbers. A Food Safety News article about food testing and accreditation published in October 2013 states:
But, when it comes to testing our food, experts estimate that less than five percent of the food testing laboratories in the U.S. are accredited according to international standards…
Some believe that FDA will begin requiring accreditation for at least some significant segment of the food testing industry, of which the U.S. has roughly 25,000 laboratories. Whether that’s restricted to third-party labs – numbering roughly 5,000 – or will also include all food manufacturers’ internal labs is yet to be seen.
Using the writer’s sources, simple arithmetic finds 25,000 laboratories multiplied by the estimated 5% accreditation equals roughly 1,250 accredited laboratories in the United States. This, of course, falls far short of the 300 accredited laboratories noted by the major accreditation bodies. This is not to question either the writer’s sources or the websites of the accreditation bodies, but it does highlight an inconsistency in how we account for the laboratories testing our food.
To go a step further, Auburn Health Strategies produced in 2015, a survey of food laboratory directors, technical supervisors and quality assurance managers on the state of food testing. The survey, commissioned by Microbiologics, asked a series of questions, including: “Are the laboratories you use accredited?” The respondents replied that, for their on-site laboratories, 42% were accredited and 58% were not. For their outside, contract laboratories, 90% of respondents stated that these laboratories were accredited and five percent did not know.
A second question asked: “Some laboratories are accredited to an internationally-recognized standard known as ISO 17025. Is this important to you?” Approximately 77% of respondents answered affirmatively. Equally telling, 15% said they did not know or were unsure.
What we do know is that there is not a definitive accounting of food laboratories—accredited or not. This lack of accounting can present very real problems. For example, we do not have a centralized way of determining if a particular laboratory has deficiencies in testing practices or if its accreditation has been revoked. Without knowing where and by whom testing is conducted, we are at a disadvantage in developing nationwide systems for tracking foodborne disease outbreaks and notifying laboratory professionals of emerging pathogens. We most certainly do not know if all food laboratories are following recognized testing methods and standards that affect the food we all consume.
What We Need Now
FSMA includes a provision calling for the establishment of a public registry of accreditation bodies recognized by the Secretary of Health and Human Services. The registry would also contain the laboratories accredited by such recognized organizations. The name and contact information for these laboratories and accreditation bodies would be incorporated into the registry. Rules for the registry have not yet been promulgated by the FDA, but should be. This is a small step toward greater accountability.
This article was part of our April Fool’s edition. 15% of poll participants guessed that this story was fake. Nope! It’s true.
A group of organizations have united to file a lawsuit against FDA following the agency’s approval of the first-ever genetically engineered (GE) salmon. The salmon is made with the DNA from Atlantic salmon, Pacific king salmon and Arctic ocean eelpout.
Represented by counsel from the Center for Food Safety and Earthjustice, the coalition is challenging FDA’s claim to have authority to approve and regulate GE animals as “animal drugs” under the FD&C Act. The group is upset that approval of GE salmon also paves the way for the entrance of additional GE fish, shellfish and animals including chickens, cows, goats, pigs, sheep and rabbits into the market.
They are also concerned about the fact that accidental release of man-made salmon into the environment could threaten the natural population via mating or introduce new diseases. “Once they escape, you can’t put these transgenic fish back in the bag. They’re manufactured to outgrow wild salmon, and if they cross-breed, it could have irreversible impacts on the natural world,” said Dune Lankard, a salmon fisherman and the Center for Biological Diversity’s Alaska representative, in a press release. “This kind of dangerous tinkering could easily morph into a disaster for wild salmon that will be impossible to undo.”
The GE salmon has been developed by Massachusetts-based AquaBounty Technologies, Inc. On its website, the company states that if salmon escape into the wild, there should not be an issue, because the fish are sterile. “Fish grown from AquAdvantage eggs are all female and sterile, making it impossible for them to breed among themselves and with other salmon. In addition, FDA approval requires them to be grown in physically contained land-based systems, further reducing any potential impact on wild populations.”
Golden Gate Salmon Association executive director John McManus, disagrees. “There’s never been a farmed salmon that hasn’t eventually escaped into the natural environment,” he stated. “Why should we believe that long term, these frankenfish won’t be the same?”
The use of Bisphenol A (BPA) in bottles, canned foods, and even medical products has been hotly debated for more than a decade. The toxic chemical has been cited in numerous studies as a hormonal disruptor, contributing to a higher risk of asthma, certain types of cancers, type-2 diabetes, obesity, infertility, and attention deficit disorder, along with other health issues.
Nearly 200 cans were tested for the presence of BPA-based epoxy resins and other chemicals.
“This report is meant to serve as a wake-up call for national brands and retailers of canned food who are jumping from the frying pan into the fire by eliminating BPA and potentially replacing it with regrettable substitutes,” the report’s authors state. “Consumers want BPA-free canned food that is truly safer, not canned food lined with chemicals that are equally or more toxic.”
The Good News
The following food companies are no longer using BPA, and the chemical was not found in any of the cans tested from:
Amy’s Kitchen
Annie’s Homegrown
Hain Celestial
ConAgra
“Our analysis showed that, across the board, canned food manufacturers both large and small are not making good on their promises to discontinue use of BPA.” – Buyer Beware: Toxic BPA & Regrettable Substitutes in the Linings of Canned Food
The Bad News
“Grocery stores, big box retailers and dollar stores are not doing enough to eliminate and safely replace BPA in their canned food,” according to the report. About 62% of retailers’ private label canned food tested positive for BPA-based epoxy resins, including those from Albertsons, Dollar General, Dollar Tree, Kroger, Target (100%), Trader Joe’s, Walmart (88%) and Whole Foods. However, some of these retailers have adopted policies to lower BPA use in their cans. Whole Foods, for example, has stated that its buyers are not accepting new cans that have BPA in the lining. The report called out the following national companies for testing positive for BPA in its cans:
Campbell Soup Company: 15 out of 15 cans
Del Monte: 10 out of 14 cans
General Mills: 6 out of 12 cans
McCormick & Co: (Thai Kitchen). 3 out of 3
Nestle Carnation: 3 out of 3
According to the report, Campbell’s, McCormick and Nestle have stated that they will move away from using BPA either this year or in 2017.
Although some companies may have initiatives in place to halt the use of BPA-based epoxy in canned goods, some of the other substitutes could be harmful as well. Aside from BPA, the main types of coatings found among the tested cans were acrylic resins (some of which were polystyrene, which is a potential human carcinogen), oleoresin, polyester resin, and polyvinyl chloride copolymers (a known carcinogen, PVC was found in 18% of private-label cans and 36% of national brands).
The report recommends that manufacturers and retailers make a commitment (and provide a timeframe) to eliminate BPA from all packaging and find safe substitutes. This may be easier said than done considering there isn’t a wealth of data on the safety of BPA-epoxy substitutes. The authors called on industry to take several additional actions:
Accountability on the part of can-lining suppliers via public disclosure of the chemical composition of can linings, along with assessment of their effect on health
Twenty-two organizations in 19 states and Ontario, Canada participated in the report, which was produced by the Breast Cancer Fund, Campaign for Healthier Solutions, Clean Production Action, Ecology Center, Safer Chemicals Healthy Families’ Mind the Store Campaign, and Environmental Defence.
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