Specific Training Required Under FSMA: A Look at Each Rule

By James Cook
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All seven core rules of FSMA require general training of individuals or employees and qualified individuals requiring education, training or experience to perform specific tasks. By including training in these regulations, the FDA has made specific training mandatory.

Training Required by FSMA Final Rules

In the current Good Manufacturing Practices (cGMP) and preventive control rules, as per 21 CFR 117.4 and 507.4, all individuals engaged in the manufacturing, processing, packing and holding of food must have the education, training or experience to perform assigned duties and must be trained in the principles of food hygiene and food safety. However, the preventive controls qualified individual (PCQI) and qualified auditor, to rules 21 CFR 117.180 and 507.53, can be an individual who has successfully completed a class equivalent in curriculum to that recognized by the FDA, or have the necessary job experience. In both cases, the training must be documented, including the date of training, type of training and those personnel trained.

This means that all employees are to be trained in food hygiene and food safety to at least the standard presented in the regulations and more specifically as per the cGMP requirements. Additionally, individuals who are responsible for a specific critical control point will still need to be trained in HACCP. However, this will probably not be sufficient for an employee responsible for preventive control, as he or she may require training in Hazard Analysis Risk-Based Preventive Control (HARPC), or training specific to the area in which the employee is involved (e.g., allergens, sanitation, supply chain or recall programs, or preventive controls).

For the preventive control qualified individual and qualified auditor, the training needed may be that of the approved FDA curriculum, as developed by the Food Safety Preventive Control Alliance (FSPCA). Although this training course is not a regulatory requirement, FDA inspectors and other regulatory personnel who are auditing facilities will have completed this training, meaning qualified auditors will be expected to have this training, and eventually preventive controls qualified individuals (PCQIs) will be expected to do so too. The qualified auditor and a PCQI will still require the education, experience and other training to perform the specific job duties as listed in the regulations. Unfortunately, it is likely that neither the industry nor the government will have enough lead instructors ready to train everyone who would want or need to be trained before the compliance dates become effective. Additionally, this training course is not yet available for animal food, and the industry has been informed by FSPCA that a Foreign Supplier Verification Program (FSVP) training module will be added to the training course. The FSVP is discussed in the Supply-Chain Preventive Control module, and the fact that there are some similarities between these regulations helps individuals involved in the FSVP program, or in auditing it.

In the produce safety rule, training requirements are listed in subpart C 21 CFR 112.21, 112.22, 112.23 and 112.30. Personnel who require training are those handling covered produce and their supervisors. As with the cGMP and preventive control rules, the principles of food hygiene and food safety must be taught to these personnel. More specifically they must learn how to identify an ill or infected person, and be taught about microorganisms of public health significance, such as Salmonella, Listeria and E. coli O157 on food contact surfaces. Additionally, personnel who harvest covered produce must be trained in recognizing produce that is contaminated with known or reasonably foreseeable hazards to ensure it isn’t harvested. These personnel must be trained in the use of harvest containers and equipment to ensure that they are functioning properly, clean and maintained, and to identify when they are not. At the same time, employees must be trained in correcting any issues or in reporting them to a supervisor in order to have them corrected. All this training must be documented in the same way as the cGMP and preventive control programs.

Unlike the cGMP and preventive control rules, the produce safety rule’s requirement to have a qualified individual, supervisor or responsible party on each farm that has completed a recognized FDA course, or equivalent, is not optional. This course will be available through the Produce Safety Alliance and is anticipated to start in September 2016. The grower food safety course required for supervisors will include an introduction to produce safety, worker health and hygiene training, soil amendments, wildlife, domestic animals and land use, agricultural water, post-harvest handling and sanitation, as well as how to develop a food safety plan.

The training for produce, conducted by the Produce Safety Alliance and/or trained trainers, does not cover training for sprouts; training for sprouts is being developed by the Sprout Safety Alliance and will include topics specifically for sprouts, such as antimicrobial treatment of sprouting seeds.

In the FSVP, the qualified individuals must have the education, training or experience necessary to perform activities as per 21 CFR 1.503. These qualified individuals will develop the FSVP and those activities such as hazard analysis, supplier approval, determining verification activities and frequency, corrective actions and other activities for the FSVP. These personnel must be able to read and understand the records to be reviewed for this program. This means they must know English and may also need to know the local language at point of product manufacture or farming. 

At this time there is no structured training program for these individuals, but the FSPCA training program, alongside education and experience can provide the training necessary for these people to perform the job activities. A PCQI would be qualified for the role of a FSVP qualified individual, but the FSVP probably would not be qualified for the PCQI role. This is because the activities in the FSVP are not as complicated as those required by the cGMP and preventive controls rules, and therefore the FSVP qualifications would not need to be as stringent.

Training Under Proposed Rules

In the proposal for Sanitary Transportation of Human and Animal Foods, 21 CFR 1.910, the FDA requires carriers of these products to train personnel who are engaged in transportation operations. This should include awareness of potential food safety problems that may occur to food during transport, basic sanitary practices that would address those problems and the responsibilities of the carriers in the regulation. As with all training in these regulations, the type of training, who was trained and when they were trained must be documented.

Since this is a proposal, the training for teaching the carrier’s responsibility is not yet finalized but will require nothing more than explaining that section of the regulation. The training of potential food safety issues and the problems that might occur during transport are handled during standard cGMP and food safety training.

For the proposed Intentional Adulteration rule, per 21 CFR 121.160, the personnel and supervisors assigned to the actionable process steps must receive training in food defense awareness and their responsibilities in implementing the migration strategies. Also, as per 21 CFR 121.130, the vulnerability assessment is to be performed by a qualified individual, and this individual is to be qualified through experience and/or appropriate training.

For basic food defense, the FDA offers various courses and information, such as Food Defense 101, on their food defense webpage. An online course is offered in English and Spanish and covers the awareness training and the regulations for employees. Upon course completion, a certificate is provided. The agency also has a downloadable food defense plan builder that can be used to develop a food defense program. The agency also provides vulnerability assessment software, but additional training in PAS 96 or ISO/TS 22000 food defense would aid qualified personnel in making sure that this vulnerability assessment is correct and that the strategies to reduce risks are appropriate and not excessive.

There is an abundance of training courses and materials available from the FDA, USDA FSIS, associations and industry. FSMA employee training requires having personnel with the proscribed education and experience to perform specific tasks, and that they be trained as soon as possible in order for them to develop the programs. Additionally, all personnel should be trained at least annually in food hygiene, food safety and food defense.

Veterinary Drugs Analysis, Food Safety

Veterinary Drugs Analysis to Ensure Food Safety

By Olga I. Shimelis
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Veterinary Drugs Analysis, Food Safety

Monitoring for veterinary drug residues is conducted to ensure food safety and compliance with approved veterinary medicine practices. Veterinary drugs are used in animal husbandry for a variety of reasons, including as a curative/preventive of disease in herd and flock, to improve meat quality, and to promote growth. The chemical classes of drugs that may be used are broad, but major classes include antibiotics, anti-parasitics, and hormones. While risk-modifiers are used to minimize risk for consumption, residues from these drugs, their breakdown metabolites, or associated impurities of the drug may persist in animal tissue, necessitating the requirement that contaminant testing be undertaken.

In the United States, trace analysis of contaminants in food products began in the early 1970s following amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA) in 1968. Worldwide, the regulatory requirements for contaminants in food have seen significant tightening due to a number of high-profile contamination crises and increased trade of food across country borders. From the technology standpoint, lower detection limits have been made possible by improvement of the detection capabilities of the analytical methods and instruments. Some of the most stringent requirements for contaminants in food are found in the European Union, where the levels of contamination should be below Minimum Residue Limits (MRLs), whereas in the United States, such limits are called U.S. tolerances.

Veterinary Drugs Analysis, Food Safety
Image courtesy of MilliporeSigma

When analyzing for drug residues, the choice of tissue has historically been the liver and kidney tissues, as these organs serve to remove the contaminants from the body and, as a result, the concentration of contaminants there is higher and easier to detect. Muscle tissue now often is added to the target list, as its contamination would have a direct impact on consumers.

With regards to veterinary drugs testing, one can distinguish between screening methods and confirmatory methods. The former should be fast and high-throughput and used to detect the presence of an analyte. The confirmatory methods should be able to provide confirmation of an analyte’s identity and quantitation at the levels of interest. Microbiological methods were popular for screening of antimicrobial drugs since these drugs inhibit growth of microorganisms, but suffer from a lack of specificity since not all microorganisms are equally sensitive to all antibiotics. Rapid screening methods include immunoassay-based testing kits, which are specific, fast, and can include multiple antibiotic classes in one test. Confirmatory methods typically include chemical analysis techniques with LC-MS detection, which provides the best ionization for most classes of veterinary drugs, along with better selectivity for focused analysis and lower detection limits. LC-MS can provide specific analysis of compounds from multiple classes in the same run through either targeted MS/MS or non-targeted analysis of unknowns through high mass resolution methods. The speed of LC-MS analysis has improved with the introduction of ultra-high pressure liquid chromatography-MS (UHPLC-MS) instruments. In the last few years, UHPLC-MS methods simultaneously serve as screening and confirmation methods for multiple classes, so called “multi-residue methods”. Some of these methods use MS/MS detectors and some use high-resolution mass spectrometers utilizing time-of-flight and ion trap detectors. These methods now can provide fast turn-around time and better accuracy in comparison to microbiological methods. They may be preferentially used by testing laboratories that are equipped and capable of utilizing the latest MS instrument technologies.

The 4th Annual Food Labs conference provides practical solutions and best practices on running, managing and equipping a food lab. | March 7–8, 2016, Atlanta, GA | LEARN MOREAll mass spectrometry methods that strive to perform simultaneous analysis of multiple veterinary drug classes are prone to the same drawbacks. Due to the differences in the analytes’ polarity, acidity and hydrophobicity, the quantitative extraction of analytes from tissue samples could be difficult. Ideally, the sample preparation methods should be compatible for compounds with varying physico-chemical properties but still provide selective separation from the matrix components to avoid occurrence of matrix effects during quantitation. The co-extracted matrix impurities are undesirable since they can affect the ionization of targeted analytes and result in under- or over-estimation of their concentration (ion suppression or enhancement). Due to the difficulty in designing a method that works for a wide variety of analytes, cleanup is often omitted for multi-class multi-analytes methods, and the stable isotope internal standards are used to correct for ionization effects during quantitation. However, omitting the sample cleanup could lead to other methodology problems.

As noted in the veterinary drug analysis session during the 2015 AOAC Annual meeting, sample cleanliness can result not only in matrix effects and impact quantitation, but it can also have an effect on the mass accuracy when high-resolution mass spectrometry is used and, therefore, can affect the identification of the analytes and lead to false negatives.

The most often used methodologies for sample cleanup during analysis of veterinary drugs in tissues is solid-phase extraction (SPE), both in cartridge and dispersive formats. C18 SPE proved to be a very versatile sorbent that often resulted in the best cleanup and best precision of analysis, closely followed by polymeric sorbents when applied to multi-class LC-MS analysis.

Aminoglycosides Antibiotics

Aminoglycosides is one class of veterinary antibiotics that is hard to include into multi-class methods. The aminoglycoside structures include connected modified sugars with different number of substituents including hydroxy- and amino-groups. The higher degree of polarity for aminoglycosides contributes to their solubility properties: these compounds are freely soluble in water and to some extent are soluble in lower alcohols, but are not soluble in common organic solvents and have solubility issues in solvent-water mixtures with high organic contents. Therefore, the normal extraction conditions that include organic solvents and are frequently applied to most other classes of veterinary drugs do not work well for aminoglycosides. A separate method is often used to extract and analyze these antibiotics.

Most often aminoglycosides are detected by mass spectrometry through the formation of positive ions during electrospray ionization. The LC separation of aminoglycosides could be done by either a reversed-phase (RP) method with ion-pair mobile phase additive to insure the retention of compounds or by HILIC chromatography. We have investigated both methods and looked at the sensitivity for detection of these compounds. The use of ion-pair is most often presented as a disadvantage, as it can reduce the analyte signal through the decrease of ionization efficiency and fouling the LC-MS instrument. While the use of ion-pair in our study decreased the ionization for some of the lighter compounds in this class (streptomycin, puromycin), ionization efficiency increased for the heavier mass compounds (gentamycin, neomycin). RP chromatography resulted in improved separation of the analytes compared to HILIC. LC-MS fouling from the use of HFBA was not observed in our investigation that spanned the course of a couple of years. In the HILIC mode with use of formic acid as a mobile phase additive, the detection of neomycin was problematic due to very low sensitivity. It was as low as one seventh of the sensitivity obtained by RP method.

The instrument response for aminoglycosides also depends on sample extraction and cleanup and the accompanying matrix ionization effects. The extraction from animal tissues has been traditionally done using the McIlvaine buffer that includes 2% Tricloroacetic acid (TCA) to precipitate proteins and release any bound analytes and 0.4 mM EDTA to prevent the binding of the analytes to cations and/or glass. Then the extract undergoes cleanup steps using SPE. The SPE sorbent most often used is a cation exchange phase, as the aminoglycosides have ionizable amino-groups and can be retained from the extract through ion-exchange interactions. Another option for the SPE cleanup became recently available—molecularly imprinted polymeric (MIP) SPE. MIPs, which are sometimes called “chemical antibodies”, mimic the performance of immunoaffinity sorbents. MIPs have binding sites that conform to the shape and functionality of  a specific compound or a compound class. Strong binding of the analyte to the MIP makes it possible to perform intensive SPE washes that lead to very clean samples. Unlike immunoaffinity sorbents, MIPs are compatible with organic solvents and strong acids and bases.

Selective interactionWe have tested the MIP SPE versus the traditional weak cation exchange (WCX) SPE cleanup for aminoglycosides spiked into pork tissue. The resulting ionization effects were compared as an indication of samples cleanliness. The quantitation in both cases was done using matrix-matched calibration curves and in both cases the recoveries for most of the ten tested aminoglycosides were above 70% (with exception of spectinomycin at 33% in case of WCX cleanup and tobramycin at 55% in case of MIP cleanup). For the two cleanup methods, there was a significant difference in matrix effects. In Figure 1, matrix factors close to 1.0 indicate little to no matrix influence for analyte detection: the ionization of the analyte in mass spectrometer is not influenced by co-extracted matrix impurities and quantitation values are not skewed. Values for matrix factors that are significantly greater than 1.0 suggest matrix enhancement for the analyte and values less than 1.0 are considered to be the result of matrix suppression. Significant matrix suppression was observed for all analytes when WCX SPE was used for cleanup. The ion suppression effect was significantly less for samples cleaned using MIP SPE. In addition, we observed significant time savings when using the MIP SPE cleanup method, as it did not require sample evaporation after using water-containing elution solvent.

Figure 1. Matrix factors close to 1.0 indicate little to no matrix influence for analyte detection
Figure 1. Matrix factors close to 1.0 indicate little to no matrix influence for analyte detection

Conclusions

While improvement in the laboratory instrumentation allows the simultaneous and fast analysis of multiple contaminants, sample preparation remains important for reliable identification of contaminants in screening methods and error-free quantitation in confirmatory methods. Both the extraction and sample cleanup methods can contribute to accurate multi-class methods analyzing wide variety of veterinary drugs. New and upcoming technologies such as molecularly-imprinted polymers could be used for more targeted analysis of specific classes of analytes via instrumental methods.

Audit

The Multi-Step Process of Third-Party Accreditation

By Charles Breen
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Audit

The FSMA Third Party Accreditation (TPA) final rule was published in the Federal Register in final form on November 27, 2015. Although TPA is not limited to imported food, its primary use will most likely be for food imports. TPA offers foreign food facilities and food importers a way to show FDA that the items coming to the United States meet federal food safety requirements.

An acceptable audit by a certified auditor is the only way an importer can take advantage of another FDA program, the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food. If FDA deems it necessary, the agency can also require certified audits for the import of specific foods.

The TPA process requires a number of administrative steps by FDA and non-FDA entities before the first third-party inspection is made. The four major steps are:

  • FDA is responsible for officially recognizing accreditation bodies.
  • An officially recognized accreditation body will accredit third-party certification bodies.
  • The accredited third-party certification body will certify third-party auditors.
  • The certified auditors will conduct consultative and regulatory audits of food facilities.

If FDA does not find an applicant that it can officially recognize as an accreditation body within two years, it may directly accredit third-party certification bodies.

In order to recognize an accreditation body, FDA must review an applicant’s legal authority, competency, capacity, conflict-of-interest safeguards, quality assurance and record procedures. By using an already existing framework familiar to industry, accreditation bodies and certification bodies will be allowed to use documentation of their conformance with the International Organization for Standardization and the International Electrotechnical Commission (ISO/IEC) standards, supplemented if necessary, in meeting program requirements under this rule. An official recognition of an accreditation body is granted for up to five years.

FDA is authorized to recognize a foreign government/agency or a private third party as an accreditation body under TPA.

Recognized accreditation bodies under TPA will be required to:

  • Evaluate potential third-party certification bodies for accreditation, including observing representative samples of the prospective certification body’s work
  • Monitor performance of the third-party certification bodies it has accredited, including periodical on-site observations, and notifying the FDA of any change in, or withdrawal of, accreditations it has granted
  • Self-evaluate and correct any problems in their own performance
  • Submit monitoring and self-assessment reports and other notifications to the FDA
  • Maintain and provide the FDA access to records required to be kept under the program

Once accredited, third-party certification bodies under TPA are required to perform unannounced facility audits, and to notify the FDA if a condition is found that could cause or contribute to a serious risk to public health.

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Employee learning, Huddle guide

Trends in Digital Learning

By Holly Mockus
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Employee learning, Huddle guide

The food industry is becoming increasingly fast-paced. Regulations are changing, the supply chain is becoming more transparent, and resources are harder to access. To meet the needs of an ever-changing industry, digital learning is becoming the go-to solution for training managers and frontline food handlers alike, as it can be done quickly and efficiently. Now that most people have smartphones and mobile devices, there are multiple ways to make learning accessible.

Employee learning
Image courtesy of Alchemy Systems

The “Mind of the Food Worker” study conducted by the Center for Research and Public Policy (CRPP) points out that food workers have developed a preference for digital training over traditional classroom or instructor-conducted training. There are many new approaches to learning, including web-based eLearning, kiosk, gamification/competition, social media, digital signage, and coordinated communication programs. Let’s take a closer look at each of these.

eLearning

eLearning is no longer about reading through a PowerPoint presentation or watching a pre-recorded video. The number of companies offering eLearning continues to increase, as do the topics, content and format of the content. In addition, eLearning carries the added benefit of being affordable. For many companies, saving on the cost of travel when an individual attends a workshop provides an attractive incentive.

The ability to learn at one’s own pace at the time and place of one’s choosing has special appeal for today’s learners. The availability of eLearning via mobile devices is meeting that desire. It can be seen everywhere—people glued to their mobile devices while waiting in line, taking a lunch break, or in the evenings on their own time. This is multitasking at its finest.

Kiosks

The ability to take a device to a quiet environment helps with concentration and efficiency in training. Kiosks can be set up in an area that is conducive to learning with no traffic, noise or other distractions and are popping up at workplaces more and more. Learners can come and go at their convenience. A learning lab set up in a manufacturing facility will pay for itself very quickly. Sending workers to the lab one at a time is much more cost effective than shutting down a line or area of the plant for group or classroom training.

Gamification

Gamification, the use of interactive tools in conjunction with learning, is a term being used more often in training industry vocabulary. For example, it can involve the addition of a word and a definition-matching exercise in conjunction with a training module to encourage learners to retain what they have just learned. It also makes the education process more fun—and it seems to be working.

Gone are the days of sitting through hours and hours of dry lectures or reading textbooks that simply do not resonate. This method has always been especially difficult for employees working in a food plant. Sitting in a warm darkened room listening to a droning presentation is an invitation to sleep. Gamification eliminates the droning, and requires attention and participation.

The Association for Psychological Science has confirmed that competition engages learners, drives retention, and leads to higher test scores. Got a boring topic for training?  Get your game on!  A great example of gamified learning that is readily available is Merriam-Webster’s Word of the Day. Sign up for free and receive a daily email with a new word, along with its pronunciation, definition(s), use and history. The email also links to several great games that provide word calisthenics for the brain.

Social Media

Leveraging social media helps to expand and continuously improve training programs. This mode of technology will ensure that every employee in a company has timely, consistent answers to questions. Using private company social media provides a safe environment for posting questions and answers while complementing a training program and filling any knowledge gaps. The CRPP study points out that 80% of workers regularly use public social media platforms such as Facebook and LinkedIn.

Companies can take full advantage of this familiarity with social media by providing an internal forum that encourages open discussion and group learning. This approach enables the workforce to engage in an interactive learning path that is continually up to date. Internal social media also encourages networking, which fosters a sense of camaraderie between individuals, along with company loyalty. One major food company that has used this approach has seen employee questions flourish from 3,000 entries in the first year to more than 15,000 the following year. What an incredible way to keep the workforce updated minute by minute with appropriate, relevant answers to their inquiries.

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The Future of Technology, Compliance and Food Safety

By Jason Dea
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There is no question that we are in the midst of a unique time period in history. Technology is continuing to innovate at an increasingly rapid rate, which has led to drastic changes that affect nearly every corner of day-to-day life. From the way we find information to our food choices, technology is influencing our lives in new ways.

The Rise of the Internet

Mary Meeker, the venture capitalist who was dubbed the “Queen of the Internet” more than 15 years ago, has described the current Internet age as a period of reimagining. At the heart of this reimagining has been the rapid growth, maturity and adoption of the Internet and Internet-enabled technologies.

In her most recent 2015 research, Meeker published some fascinating statistics. The number of people online has ballooned more 80 times, from a user base of a mere 35 million in 1995 to a staggering 2.8 billion users in less than 20 years. This figure translates into nearly 40% of the total global population.

InternetUsers_2014
A breakdown of the 2.8 billion Internet users in 2014. This figure (39% global penetration) exploded from the approximately 35 million users in 1995. Source: Internet Trends 2015 – Code Conference

It hasn’t just been the volume of usage that has evolved radically. The nature by which those billions of users are signing online has also changed. It’s hard to believe that the original iPhone was released in 2007, less than 10 years ago. In that time, the mobile Internet has gone from a novelty to a necessity for many of us in our daily lives. This smartphone adoption has fueled Internet use and has drastically increased the ease with which consumers can get online.

Reimagining Communication and Compliance

The result of our new “always-on,” globally connected world (to borrow Meeker’s term) is a complete reimagining of communication. Consumers expect a velocity and volume of communication that the world has never before experienced. We now take for granted that we can reach friends, family and acquaintances anywhere in the world—at any time—in an instant. This has also drastically changed our expectations of business relationships.

Consumers in an ever-connected world have an expectation of availability and transparency of information from the brands with which they interact and the establishments they frequent. What this means for businesses is that customers expect to have a degree of access to business data that they’ve never asked for previously.

A tangible side effect of this desire for data transparency can be seen within the regulatory environment that organizations operate. Governments and regulatory bodies have increased their expectations of data access and availability over time, resulting in more stringent regulations across the board.

Research from Enhesa shows that the regulatory growth rate is nearly as staggering as Internet growth rates. According to the firm’s research, from 2007–2014 regulatory increases by region were as follows:

  • North America: +146%
  • Europe: +206%
  • Asia: +104%

Impact on Food Safety: Consumer Engagement and Regulatory Growth

One particular area of regulatory growth has occurred within the food and beverage sector. Arguably no product category has a more direct impact on consumers than food, as it literally fuels us each day. It’s no wonder that in an environment of increasing regulations and more empowered consumers that food quality and food safety are under increased scrutiny.

In today’s environment, it becomes much more challenging to brush aside product recalls and food safety incidents or bury these stories in specialized media. The latest news is not just a fleeting negative headline. In a worst-case scenario these incidents are viral, voracious and more shareable than ever before. From Listeria outbreaks to contaminated meat to questionable farming practices—when fueled by the Internet, the negative branding impact of these stories can be staggering. Consumers are paying attention and engaging with these stories—for example, during a Listeria or Salmonella outbreak, online searches for these terms significantly rise.

The rise of hyper-aware consumers has had a measurable impact. As a result, governments have been quick to respond and have beefed up existing regulations for the food and beverage sector via FSMA and GFSI.

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FSMA

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

By Marsha Madrigal
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FSMA

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.

Resources

  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

Top 10 Tips for Creating a Sustained Food Safety Culture

By Holly Mockus
5 Comments

After much anticipation, FDA has finally published the FSMA final rules. If you’ve had time to dig into the details, you most likely noted the new initiative that requires companies to measure food safety culture. The industry is also seeing SQF, BRC and other GFSI audit schemes ramping up discussions around measuring food safety culture. However, FDA and GFSI audits aside, how do you create a culture for sustained compliance with this initiative? Follow these 10 tips to ensure your food safety culture is constant and in line with the new requirements

Photo credit: Dennis Burnett for Alchemy Systems
Set clear expectations for employees across the board. Photo credit: Dennis Burnett for Alchemy Systems

1: Create a solid foundation of programs, procedures and policies

Have a preset annual schedule for review and update of all programs, procedures and policies. Don’t let the schedule slide because there are competing priorities. A small pebble is all it takes to start ripple effect in the company, making it difficult to recover.

2: Set clear expectations, driven from the top down

Everyone should follow the rules and guidelines—from visitors to the CEO to the plant manager to the hourly employee. A “no exceptions” policy will drive a culture that is sustainable and drive a “this-is-just-how-we-do-things” mindset.

3: Use record keeping to ensure that food safety culture is well documented and data-driven

Collect the data that is measureable and non-subjective to help drive continuous improvement. If you collect it, you must do something with it. Good documentation is imperative to proving you did what you said you were going to do, especially in the event of an audit. Be stringent in training, and review all documentation before it hits the file cabinet to ensure it is accurate and appropriate.

4: Implement a robust continuous improvement process

Forward momentum through a continuous improvement process cannot be achieved unless management nurtures the program. If you are not continuously improving, you are falling behind.

5: Have a 360-degree approach to employee engagement with 24/7 awareness and communication

Top-down communication is critical to highlighting the priorities and needs of an organization and will not be effective unless an organized program is in place. Organizations that are not making the necessary pivots to communicate with the multiple generations within their workplace today will struggle to sustain change.

6: Foster an atmosphere of mutual respect

Treat people as you would like to be treated, turn the other cheek, etc. There may be lots of adages you quote, but which one best describes your facility and the relationships with management and peers on a daily basis?

7: Be sure employees have consumer awareness for the products they produce

Do your employees know who the end consumer is of the product that they are producing every day?  Does your culture include a review of consumer complaints and customer complaints with your frontline workers?  Listening in to a call center is a very powerful way to help employees understand what affects consumers and how their job is critical to avoiding a food safety or quality issue.

8: Create accountability across the board

Hold folks who do not support the culture in which you are striving to develop or maintain accountable, regardless of their position or stature.

9: Provide positive reinforcement. It’s the best motivator

Work to catch people doing things right and make a big fuss when you do. Positive reinforcement for a job well done is the most powerful motivator. It helps keep every team member on board with food safety commitments.

10: Celebrate often

We spend too much time at work not to celebrate all the good things that are accomplished. Whether it’s a cake and recognition for those that served in the armed forces on Veterans Day or a successful launch of a new product—celebrations are a great way to recognize and reinforce your employees’ hard work. Identifying and correcting mistakes should also be celebrated; they are fertile ground for making changes and provide great nutrients for continuous improvement.

Prevent Contamination from Defects in Metal Can Food Packaging

By Wayne D. Niemeyer
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Millions of aluminum and tin-plated steel cans enter the marketplace every day, yet despite the extensive efforts of manufacturing plant quality control systems, a small percentage of the cans may have defects that can result in loss of the can integrity and subsequent contamination of the food products. Quality control operations within manufacturing plants typically have limited analytical chemistry capabilities and must rely on the manufacturer’s laboratory or independent laboratories to help identify and characterize the defects and troubleshoot the operations to eliminate the root cause of the defects. This article will present some of the current technology utilized for evaluating metal can defects.

Metal cans made from aluminum for beer and beverage products have been in use for about 50 years, whereas tin-plated steel cans for food products, have been in use for more than 100 years. Throughout that time, many improvements have been made to the design of the cans, the materials used for the cans (metal and internal/external protective organic coatings), the manufacturing equipment, chemical process monitoring, and quality control methods/instrumentation. The can manufacturing plants and their material suppliers are responsible for product integrity prior to distribution of the cans to food and beverage manufacturing operations throughout the world. Incoming quality control and internal quality control are also quite extensive at those manufacturing locations. Many of the can defects that would result in potential consumer issues are quickly eliminated from the consumer pipeline as a result of the rigorous quality control procedures. Occasionally, defective cans find their way into the marketplace, resulting in consumer complaints that must be addressed by the manufacturers.

The cause of the defects must be determined quickly, even if it means shutting down production lines while waiting for answers and corrective actions. Anything that results in a major product recall will have a high priority for the manufacturers to determine the root cause and take corrective actions. Major manufacturers have extensive analytical laboratories with a vast array of instrumentation and technical expertise for troubleshooting the defects. Smaller manufacturers usually have to rely on a network of independent laboratories to assist with their troubleshooting analyses.

Instrumentation and Methodology

Most major can manufacturing plants produce several hundred thousand to several million cans per day, and any can defects detected during quality control inspections will obviously have major implications. Most aluminum and tin-plated steel cans have an organic protective coating applied on the interior surface. One of the major quality control tests is to determine the amount of metal exposure inside the cans. This is done through the use of Enamel Rater instrumentation in which a sampling of cans are filled with an electrolyte. An electrode is immersed into the liquid and external contact is made with the can’s bottom or side wall. When a voltage is applied to the system, the current generated is directly proportional to the amount of exposed metal; a very small amount of exposed metal is acceptable. By reversing the polarity of the system, exposed metal regions produce gas bubbles as a result of the electrochemical reactions. This allows the inspector to identify the location of the exposed metal.  When too much metal exposure is encountered, the troubleshooting process begins immediately.

Crater defect, stereomicroscope
Figure 1. Stereomicroscope image of a crater defect with an iron oxide (rust) particle in the center. (Click to enlarge)

Visual examination of additional cans from the production line is done, followed by examination with a low-power microscope, typically a stereo microscope, in order to characterize metal exposure defects. Typical defects are craters and/or fisheyes, which are seen as circular dewetting (also known as pullback) of the coating from a solid contaminant on the metal (see Figure 1) or an incompatible liquid, such as machine oil mist (fisheye). Additionally, broken blisters in the coating, known as solvent pops, can occur in the curing oven for the coating, resulting in exposed metal. The metal exposure produces two main problems for the filled food product: Metal migration into the product and corrosion of the metal, which eventually results in perforation and product leakage. Manufacturing plants typically do not have the necessary analytical instrumentation available to identify the contaminants and must send selected samples to the laboratory for the analysis.

Another critical test that is conducted in the can manufacturing plants looks for adhesion characteristics of the internal coatings and external coatings (inks and over varnish). A typical adhesion test involves cutting open the sidewalls and immersing the cans into hot water for a period of time. Upon removal from the water, the cans are dried and a tool is used to scribe the coatings. A tape is applied over the scribe marks and rapidly pulled off. If any coating comes up with the tape, the troubleshooting process must begin. Often, over-cure and under-cure conditions can result in coating adhesion failure. The failure can also be caused by a contaminant on the surface of the metal. Loss of internal coating adhesion can result in flakes of the coating contaminating the product and also metal exposure issues. Adhesion failure analysis is typically conducted in the analytical laboratories.

Analytical laboratories are well equipped with a vast array of instrumentation used to identify and characterize various can defects, including:

  • Optical microscopes, both stereomicroscopes and compound microscopes, are used with a variety of lighting conditions and filters to observe/photograph the defects and in some cases perform microchemical tests to help characterize contaminants. They are also used to examine metal fractures and polished cross sections of metals looking for defects in the metal that may have caused the fractures.
  • Scanning electron microscope (SEM) equipped with the accessory for energy dispersive X-ray spectrometry (EDS) are used, in conjunction with the optical microscopes, to observe/photograph the defects in the SEM and then obtain the elemental composition of the defect material with the EDS system. This method is typically used for characterizing inorganic materials. Imaging can be done at much higher magnifications compared to the optical microscopes, which is particularly useful for analysis of fractures.
  • Infrared spectroscopy, commonly referred to as Fourier Transform Infrared (FTIR) spectroscopy, is used mainly to identify organic materials, such as, oils, inks, varnishes, cleaning chemical surfactants that are commonly found in the can manufacturing operations. Solvent extractions from adhesion failure metal surfaces and the mating back side of the coating are often done to look for very thin films of organic contamination.
  • Differential scanning calorimetry (DSC) instrumentation is often used to determine the degree of cure for protective coatings on cans exhibiting adhesion failure issues.

Other more specialized instrumentation that is more likely available in independent analytical laboratories includes:

  • X-ray photoelectron spectroscopy (XPS), also known as electron spectroscopy for chemical analysis (ESCA), is used to analyze the outermost molecular layers of materials. The technique is particularly useful for detecting minute quantities of contaminants, typically thin films involved in adhesion failures. Depth profiles can also be done on the metal to determine thickness of oxidation or the presence/absence of surface enhancement chemical treatments. High-resolution binding energy measurements on various elements can provide some chemical compound information as part of the characterization.
  • Secondary ion mass spectrometry (SIMS) is also an outer molecular layer type of analysis method. Depth profiling also be accomplished with this instrumentation, but one of the major advantages is the ability to detect boron and lithium which are found in some greases and other materials in the manufacturing facility. To help identify organic films that may have resulted in the adhesion failures, it is often crucial to know if boron or lithium is present, which helps identify a potential source.
  • X-ray diffraction (XRD) instrumentation is used to identify crystalline compounds, mainly inorganic materials but can also be used for certain organic materials. Inorganic materials, isolated from coating craters, are often identified with a combination of SEM/EDS and XRD analyses.

Three case studies are presented to show how analytical lab instruments can be used to identify and characterize metal can defects.Metal can defects can take on numerous forms, some of which have been discussed in this article. Extensive quality control activities in can manufacturing plants often prevent defective cans from entering the marketplace. Characterizing the cause of the defects often requires major troubleshooting activities within the production plants, supplemented by the analytical laboratories with a vast array of instrumentation and personnel expertise. Due to the huge quantities of metal cans produced each day, it is inevitable that some defective cans will make it to the marketplace, resulting in consumer complaints. High priorities must be assigned to consumer complaints to not only identify and characterize the defects, but also to determine how widespread the defective cans are within the marketplace. In this way, decisions can be made regarding product recalls.

Spherulites under can coating

Case Study: Using Analytical Lab Instruments to Find Defects in Cans

By Wayne D. Niemeyer
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Spherulites under can coating

Learn more about using current technology to evaluate defects in cans: “Prevent Contamination from Defects in Metal Can Food Packaging”

 

Case 1

Dark stains were observed on the outer surfaces of ends on tin-plated steel food cans when the cans came out of the retort sterilization system. During gentle scraping with a needle, it was determined that the stains were deposits on the surface of the clear organic protective coating. Portions of the deposits were mounted for analysis by SEM/EDS and revealed a composition mainly of iron oxide with elevated levels of calcium, chlorine and silicon. Other minor and trace elements included sodium, magnesium, aluminum, phosphorus, potassium, and zinc. It was concluded that the residues were water salts and iron corrosion products, which would be consistent with retort water residue. Apparently the retort water was not sufficiently rinsed from the cans upon exiting the retort system. These deposits, being rather loosely adhered to the surface of the coating, could easily wash off into the product when the steel ends are opened with a circumferential can opener.

Case 2

Drawn & Ironed (D&I) tin plated steel food cans are formed in high-speed machines using an emulsified lubricant in the tooling. The cans then go through a cleaning process and as a final step in the process, a water-soluble organic coating, known as a wash coat, is put on the outside of the cans by a flow curtain application method. Numerous consumer complaints were received in which the internal protective coating on the cans was losing adhesion and depositing into the product brine. Examination of the interior sidewalls of sample cans revealed film-like stains near the top of the cans where the adhesion failure was occurring. FTIR analysis of the stains identified them as the wash coat. In this case, some of the wash coat had migrated into the inside of the cans by capillary action during the can washing process. The internal protective coating that was applied later in the can manufacturing operation was not compatible with the wash coat. Several corrective actions had to be taken, which included some modifications to the wash coat flow curtain system and reformulations of the wash coat and internal coatings to make them more compatible for adhesion.

Case 3

Spherulites under can coating
Figure 1. Polarized light microscope image, with fully crossed polarizing filters, of the spherulites under the can coating. Click to enlarge

Consumer complaints were received concerning orange/brown stains in or under the internal protective coating of tin-plated steel food cans. Optical microscopy examination revealed that the stains were underneath the coating. Polarizing filters, added to the compound microscope, revealed more optical properties of the stains as shown in Figure 1. They appeared as clusters of spherulites with black crossing lines, known as isogyre lines, and seemed, at first, like typical starch grains. The coating was carefully sliced away with a razor blade in order to expose the spherulites. SEM/EDS analysis of the exposed spherulites revealed high iron, carbon and oxygen content. In order to obtain a better identification of the spherulites, a portion of the can wall was placed into a low-temperature ashing system that removed the organic coatings exposing the spherulites, which could then be isolated and mounted for analysis by XRD. The analysis revealed that the spherulites were iron carbonate. To further confirm the carbonate composition, additional spherulites were mounted on a glass microscope slide and covered with a thin glass coverslip. While observing with a stereo microscope, a drop of 1N HCl acid was placed at the side of the coverslip to wick under the coverslip to make contact with the spherulites. Upon contact with the acid, the spherulites dissolved while emitting large quantities of gaseous bubbles, which is indicative of carbon dioxide gas evolution when carbonates are dissolved in acid.

Imports

FSMA’s FSVP: Clearing the Confusion of Importing Rules

By Charles Breen
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Imports

On November 27, 2015, the Foreign Supplier Verification Programs for Food Importers (FSVP Rule) published in the Federal Register. The most significant new element is that importers are now responsible for assuring that the food they import complies with FDA requirements. Instead of action against violative food, FDA is now equipped to take regulatory action against importers that fail to provide necessary assurance of food safety.

“Importer” is defined as: “the U.S. owner or consignee of an article of food that is being offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under the FSVP regulations.” This differs from the importer of record as defined by Customs and Border Protection (CBP) as the person primarily responsible for paying any duties or an authorized agent acting on his behalf.

Under FSVP, an importer’s basic responsibilities are to:

  • Determine hazards reasonably likely to cause illness or injury
  • Evaluate the risk, using hazard analysis
  • Evaluate the foreign supplier’s performance
  • Perform supplier verification activities

Determining hazards and evaluating risk parallel the preventive control rules for human food (PCHF) and animal food (PCAF). Evaluation of a foreign supplier’s food safety performance and conducting verification activities are substantially aligned with supply-chain verification in 21 CFR 117 Subpart F (PCHF) and 21 CFR 507 Subpart E (PCAF). The importer is responsible for assuring compliance with FDA standards and requirements.

Deciding what parts of FSVP are applicable to each importer’s operation requires a comparison between what the importer does, and the exemptions, exceptions and modified requirements offered in the rule. These depend on what is imported, the food safety system in country of origin, the size of the importer, and the size of the foreign supplier. FDA delivered on its promise of flexibility, but deciding what applies requires some analysis.

If a food importer meets the definition of importer and does not fall into an exempted category or qualify for exceptions or modifications, then some or all of the FSVP rule applies to them. FDA estimates that about 55,000 importers will be covered by FSVP or some portion of it.

Who Is an Importer?

The U.S. owner or consignee of an article of food that is being offered for import into the United States is the importer. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the U.S. agent or representative of the foreign owner or consignee at the time of entry is the importer.

All importers must provide an identification number for each entry line of food that the importer brings into the country. FDA will be issuing more guidance on what it considers “an acceptable identification number.”  The agency is not mandating that each facility use a DUNS number, but is has ruled out other suggestions for the unique identification number that is required.

Exemptions to FSVP

FSVP does not apply to the following foods:

  • Fish and fishery products (in compliance seafood HACCP in 21 CRF 123)
  • Juice (in compliance with juice HACCP in 21 CFR 120)
  • Food for research or evaluation
  • Alcoholic beverages
  • Meat, poultry, and egg products regulated by USDA
  • Food imported for personal consumption,
  • Food that is transshipped through the United States
  • Food that is imported for processing and later export
  • U.S. food that is exported and returned without further manufacturing or processing in a foreign country (U.S. foods returned)

Partial exemption for import of low-acid canned foods (LACF). LACF are exempt from FSVP with respect to microbiological hazards for that food. To be exempt, the importer must verify and document that the food was produced in accordance with LACF requirements (21 CFR part 113). Other hazards not controlled by the LACF rule, if any, must be documented as controlled under FSVP.

Modified Requirements

Modified requirements for a receiving facility in compliance with the PCHF or PCAF rules that imports food:

  • If the process used controls the hazards of the imported food, the facility is considered in compliance with most of the FSVP rule.
  • If the food does not have any identified hazards requiring control, then the facility is considered in compliance with most of the FSVP rule.
  • If the facility has implemented a supply-chain program for the food in compliance with either PCHF or PCAF requirements, the facility is considered to be in compliance with most of the FSVP rule.

Receiving facilities must also accurately identify themselves to FDA for each entry line of food being imported.

Modified requirements for imported dietary supplements manufactured in compliance with CGMP requirements in 21 CFR part 111:

The importer must accurately identify itself to FDA for each entry line of dietary supplement or dietary ingredient being imported.

Modified requirements for very small importers:

Defined as less than $1 million in sales of human food a year, or less than $2.5 million in sales of animal food per year, very small importers would not have to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurances of compliance from those facilities.

Modified requirements for imports from small suppliers (i.e., qualified facilities under PCHF or PCAF, and some small farms not covered farms under the produce safety standards, and some small egg producers):

The importer must obtain written assurance before importing the food, and at least every two years after, that the foreign supplier is producing the food in compliance with applicable FDA food safety regulations or the laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States.

Modified requirements for food imported from a country with an officially recognized or equivalent food safety system:

Importers must determine that the supplier is in compliance with FDA requirements, or that the supplier is in compliance with food safety regulations or relevant laws in the country that FDA recognizes as equivalent.

At present, only New Zealand is officially recognized as comparable to the United States. FDA is in the process of auditing and evaluating audit results for mutual recognition with additional countries. The next countries to be recognized will most likely be Australia and Canada.

One final note: FSVP requires coverage of food contact surfaces, such as packaging. Manufacturers of food contact surfaces are not required to register with FDA. PCHF and PCAF rules are limited to those facilities required to register. The language requiring FSVP makes no exception for food contact surfaces.