With several FSMA compliance dates now in effect, much of the focus is on where companies need help. According to Kathy Gombas, former deputy director at CFSAN, the industry is struggling with FSMA training. Many companies don’t understand the FSMA rule exemptions and supply chain requirements, and they just don’t know where to start. “Industry needs affordable and timely resources,” said Gombas during a panel discussion at the Food Safety Summit earlier this month. “There are a lot of tools out there, but they’re costly.”
Efforts are underway to address these challenges. FDA has issued more than a dozen guidance documents pertaining to the rule. In addition, tools such as model plans and templates can help companies with their food safety plans, and the agency is almost ready to publish a web-based food safety plan builder that will be freely accessible on FDA’s website, according to Gombas. Several sources of technical assistance are available, including state and trade associations, academia, and the technical assistance network (TAN). However, when companies have inquiries, the key is to provide them with a response in a timely manner, said Gombas.
The Produce Safety rule is another hot spot for hurdles. Although 90% of it aligns with Good Agricultural Practices that have been in place for more than a decade, industry’s response to the rule remains one of fear and confusion, said David Gombas, former vice president of technical services for the United Fresh Produce Association. “Water testing is probably the most complicated aspect of the regulation,” he said. The rule calls for testing procedures that many produce companies never had to conduct before. Some testing must be done within a certain period of time, and the lower number of testing labs in rural areas of the United States will pose a problem for some producers, warned David Gombas.
There is also confusion among producers regarding whether they should follow the Produce Safety Rule or the Preventive Controls rule, which could significantly impact the steps they must take to be in compliance of either rule. To further complicate matters, Gombas pointed out that many foreign suppliers aren’t even aware that they have to be in compliance with the rule. Finally, the Produce Rule does provide a lot of room for flexibility, so Gombas predicts much of the responsibility will fall on the agency inspectors and how they expect rule to be met.
FDA, as part of FSMA, released its rule titled “Protecting Food Against Intentional Adulteration” on May 27, 2016. This rule was proposed in 2013. FDA received and responded to 200+ comments prior to its final release.
FDA states that this rule “is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Such acts, while not likely to occur, could cause illness, death, [and] economic disruption of the food supply absent mitigation strategies.”1
The rule requires a documented “Food Defense Plan” that at a minimum includes the following:
Vulnerability assessment
Mitigation strategies
Procedures for food defense monitoring
Food defense corrective action procedures
Food defense verification procedures
Records confirming implementation, maintenance and conformance to the defined requirements
Evidence of effective training
As a food safety professional with more than 30 years in the industry, reviewing this rule brought back many memories. These memories combined with information gained from a recently completed Food Defense/ Crisis Management workshop presented by Rod Wheeler really set my brain into motion.2
Years ago, industry focused on crisis management and product recall. Requirements included having a crisis management team that was led by associates representing both upper and middle management. In addition, most programs included the following:
Posted identification of the crisis management team (i.e., pictures, phone numbers, etc.)
Specific training for receptionist and guards
Mock crisis exercises (i.e., fire drills)
Planned crisis calls to the operation’s direct incoming phone numbers (i.e., receptionist and guards)
Mock recalls (from supplier through finished product and distribution)
Security inspections which may now be considered the pre-cursor to today’s “Vulnerability Assessment”
With the introduction of the GFSI approved schemes (FSSC 22000, BRC, SQF, GlobalG.A.P., Primus, etc.), requirements for crisis management, emergency preparedness, security programs, food defense training and continuity planning gained an increase focus. Do any or all of these programs meet the requirement for a “vulnerability assessment”?
In the 2013 publication, Food Safety Management Programs, this subject-matter chapter was titled “Security, Food Defense, Biovigilance, and Bioterrorism (chapter 14)”.3 An organization must identify the focus/requirements that are necessary for its operation. This decision may relate to many different parameters, including the organization’s size, design, location, food sectors represented, basic GMPs, contractor and visitor communication/access, traceability, receiving, and any other PRP programs related to ensuring the safety of your product and your facility. Requirements must be defined and associates educated to ensure that everyone has a strong and effective understanding of the requirements and what to do if a situation or event happens.
Confirming the security of a facility has always been a critical operational requirement. Many audits have been performed that included the following management statement: “Yes, of course, all the doors are locked. Security is achieved through key cards or limited distribution of door keys, thus no unwanted intruder can access our building.” This statement reminds me of a preliminary assessment that I did not too long after the shootings at a Pennsylvania manufacturer in September of 2010. The organization’s representor and myself were walking the external parameter of a food manufacturer at approximately 7:30 PM (still daylight). We found two doors (one in shipping and one accessing the main office), with the inside door latch taped so that the doors were not secure. The tape was not readily evident. The doorknob itself was locked, but a simple pull on knob opened the door. Our investigation found that a shipping office associate was waiting for his significant other to bring his dinner and was afraid that he would not be at his desk when she arrived. An office associate admitted that that door had been fixed to pull open without requiring a key several months earlier because associates frequently forgot their keys and could not gain access to start work.
Debby Newslow will present ” Sanitary Transportation for Human & Animal Food – Meeting the new FDA Requirements” at the Food Safety Supply Chain Conference | June 5–6, 2017 | Attend in Rockville, MD or via webcast | LEARN MORE
We also observed a large overhead door adjacent to the boiler room along the street side of the facility open, allowing direct access to the processing area by passing through the boiler room and then the maintenance shop. It was stated that the door had been opened earlier in the day waiting for the delivery of new equipment. No one at the time knew the status of the shipment or why the door was still open.
Finding open access to facilities is becoming more and more common. A formal vulnerability assessment is not necessary to identify unsecured doors (24/7) in our facilities. Education and due diligence are excellent tools for this purpose.
Another frequently identified weakness is with organization’s visitor and contractor sign-in prerequisite programs. What type of “vulnerability” are we creating for ourselves (false confidence) with these programs? Frequently these programs provide more questions than answers:
Does everyone really sign in?
What does signing the visitor log mean?
Are visitors required to show identification?
Are the IDs actually reviewed and if so, what does this review include?
Who is monitoring visitors and contractors and are they trained?
Do all contractors have to sign the log or are they allowed to access the building at different locations?
Do those contractors who make frequent or regular trips have their own badges and/or keys (keycards) so they don’t have to take the time to sign-in (i.e., pest control, uniform supplier vending services)?
How are contractor badges controlled?
Are visitors required to be accompanied during the visit or does it depend on the visitor and whom they are visiting?
Are visitors and contractors trained in company requirements?
Do visitors and contractors have an identifying item to alert your associates of their status (i.e., visitor badge, visitor name badge, specifically colored bump cap, colored smock, etc.)?
How are truck drivers monitored? Do they have a secured room for them or do they have complete access to the facility to access the restrooms and breakroom?
How are terminated associates or associates that have voluntarily left the company controlled?
Can these associates continue to access the facility with keys, access cards, or just through other associates (i.e., friends or associates that did not know that they were no longer an employee)?
Getting employees on board can be one of the most difficult parts of any major change within a company. When things are operating just fine from the perspective of the employee, the cries of, “but we’ve always done it this way!” can be deafening. As a manager, it is our job to explain the new requirements in a way that encourages buy-in from employees at all levels of the organization, and to always present a united front with the company, even if we do not fully understand why a change is important. It is almost a guarantee a business would not spend money implementing a major change if there was not an impetus behind it. One crack in the façade can lead to an entire shift becoming demoralized and disheartened.
Compliance with FSMA is no exception. Although the aim of the act is to reduce food safety risks to the population of the United States, the added paperwork and regulatory requirements can seem onerous to the employees responsible for doing the work. I would encourage any managers who are experiencing some feelings of “why me?” to search YouTube for the videos made by families touched by major foodborne illness outbreaks. The pregnant mothers whose babies are infected with Listeria from deli meat sandwiches are particularly heartbreaking for those who have children.
Once a manager has convinced him or herself of the importance of compliance with the new food safety regulations, it’s time to get your employees on board as well. If you can, show them the same videos you saw to encourage their buy-in. Listeria is a danger in any plant handling a ready-to-eat product or one that could be improperly cooked by the end user. Remember, cooking instructions do not absolve the manufacturer of the responsibility to produce food free of hazards! With the internet, impactful videos are only a click away. Just remember to always fully vet the video before attempting an at-work viewing party—lots of people on the internet have senses of humor that may not translate well to the workplace.
Making the issue personal also works well. This is a great way to get the message home about allergens. In any group of associates, chances are good that at least one of them will have a close friend or family member who is affected by a food allergy. Ask people to raise their hands if they know anyone who is allergic to food. Ask them what that person must do to protect themselves. Frequently, the answer is that the allergic consumer can only read the label. This is a great teaching tool for the importance of proper labeling and can be used as a lead-in to the introduction of a new Allergen Preventive Control, if one is required. Ask the employees to visualize the people they know with food allergies when completing the required records, or performing the onerous tasks, and imagine themselves as the last line of defense.
Many companies employ the services of temporary agencies. These companies can offer a great solution for a company that is concerned about the exposure to litigation that can occur through employee separation. Some industries have high levels of turnover or seasonal operations, which can prove difficult to manage for busy HR departments. Turnover can lead to a loss of accountability as well, such as when an employee informs you that their training was deficient (leading to a major snafu). If their predecessor was not in the position long enough and the chain of training was broken, it can take a substantial investment of time and energy from a senior individual to train that relatively low-paid position back to base minimum level. Outsourcing some of the work to a temporary agency can seem like a godsend at first. They find them, they train them, and all the hiring company must do is eliminate downtime. Who wouldn’t?
However, over time, many companies find the time and money they saved at the outset comes back around to bite them in the end. Temp agencies often do not keep good records, and if you are relying on them to deliver crucial introductory food safety training before they send candidates to you to begin, you may end up in a bind when your auditor or FDA investigator asks to see your training records. The obvious solution is to bring all training back in-house, but that can partly defeat the purpose of having the temp agency in the first place.
Today FDA updated its FSMA training strategy to reflect the progress made during 2016. The program, which targets farmers, small food processors and small produce merchant wholesalers, includes the following updates:
Cooperative agreement for small and mid-size businesses involved in local food production awarded to the National Farmers Union Foundation
Cooperative agreement for preparing food producers in Native American tribes awarded to the University of Arkansas in Fayetteville
Federal grants awarded for establishing regional centers to facilitate training under FDA’s partnership with USA’s National Institute of Food and Agriculture
Allergenic foods are a serious safety risk. While harmless to most of the consumer population, they are harmful and even life threatening to some, causing serious medical reactions, such as anaphylactic shock, when foods with the allergenic protein are consumed. Scientific research and legislation have helped us understand a great deal about managing these food allergens in manufacturing. Yet so much more needs to be done in making these risks safer for the growing allergic population. In 2013, the CDC reported that food allergies among children increased by half from 1997 to 2011. As these numbers continue to rise for children and adults alike, what are the best practices for food manufacturers to include in managing food allergens? Here’s what you need to know.
Evan Rosen is participating as a panelist in the session “Rubber Meets the Road: Practical Compliance with FSMA and Preventive Controls” at the 2016 Food Safety Consortium. The session will be moderated by Rajan Gupta and Dana Johnson Downing of TraceGains | LEARN MOREResearch and Development for Allergen Programs
Thorough development and foresight are essential for any food manufacturer to succeed when implementing an allergen program in its processing. It is wise for food manufacturers to select the individuals in their company who are a good fit to lead the allergen program. When developing your program, create an “allergen map” to understand where allergenic ingredients are located in your plant and how they travel while products are processed.
The R&D stage is the optimal time to plan every step of the allergen management process—from supplier sourcing to cross contact in processing, to labeling and every step in between—before the risks are actually encountered. This is in line with the new preventive controls approach to be taken with FSMA’s Food Safety Plan model.
Purchasing, Labeling and Storing Ingredients
When purchasing ingredients from suppliers, your supply sources should be just as stringent about allergen management as you are in order to reduce liability. Require your suppliers to have an allergen map of their own and lettered documentation declaring that the items you are purchasing are free from contact with food allergens. The FDA food label law currently recognizes the top eight food allergens as:
Peanuts,Tree nuts—including almonds, walnuts and hazelnuts, among others
Milk (not to be confused with lactose intolerance)
Also, be mindful of allergens that apply to the country of export, such as Sesame Seeds, Sulfites and Mustard Seed in Canada.
When receiving and storing supplier ingredients, check the labeled contents for any updates and tag the units that contain allergens so they can be easily identified and stored separately. A pictorial system is very effective. Ensure that each unit is tightly sealed, as even slight amounts of leaked allergens can pose recalls and elevated risks to your consumers.
Processing and Cleaning Cross-Contamination
Human error is only one factor that predisposes risk of cross-contact; production timing, processing lines, facility traffic, protein structure (e.g. powder, liquid, paste) and even the type of equipment used can be a game changer when it comes to the proper handling of allergens. In order to prevent allergen cross contact, scheduling long lines of products with common allergens is recommended to minimize changeovers. Dedicate unique tools, utensils and equipment that will handle the allergen if possible, as every piece contacting an allergen must be washed before handling allergen-free processing.
Assign plant employees to specific locations to avoid risk of cross-contact travel—color coding uniforms helps a great deal in managing this concept. Manufacturing equipment that is designed for easy cleaning is also ideal. For cleaning procedure of cross-contact removal, wet cleaning methods are most effective followed by dry methods. These procedures should be validated using a recognized protein-specific test method such as lateral flow or ELISA. When flushing, be sure to keep the flushed material isolated from all allergen-free areas. Careful separation and mindfulness is key to a successful allergen program.
Staff Training and Education
In order for any allergen program to be effective, all plant, production staff, contractors and visitors must be aware of the importance of it and understand the impact it has on consumers. Incorporating different learning methods helps to communicate this to them. Occasional testing and validation of applying this knowledge ensures the integrity of your allergy-free claims and establishes trust. Passion and commitment also play a vital role in achieving success in your program as a whole.
From purchasing ingredients to staff education and cross-contact prevention, one can see that plenty of work and forethought goes into having an allergen management program. With these best practices in place, food manufacturers can be well prepared for the increasing demand of allergen safe products for consumers across national and international markets.
Form a multi-year plan to implement a produce safety system
Education, outreach and technical assistance
Prioritize farming operations covered by the rule
Develop programs to address the needs of farming communities
According to FDA, “the intended outcomes of this cooperative agreement program are to:
Advance efforts for a nationally integrated food safety system (IFSS)
Plan, establish, and/or enhance state and territorial produce safety programs.
Encourage the safe production of fresh fruits and vegetables.
Promote understanding and compliance with the requirements of the Produce Safety Rule.”
Applicants were classified into five tiers of funding eligibility based on the number of farms growing covered produce within the jurisdiction. The agency has also provided a list of funding award amounts by state.
Learn more about FSMA at the 2016 Food Safety Consortium | December 7–8, 2016 | Schaumburg, IL | VIEW AGENDA
At the 2016 Food Safety Consortium, STOP Foodborne Illness will have a fundraiser to honor heroes in food safety. |December 6, 2016, 7–9 pm | LEARN MOREIn 2012 STOP Foodborne Illness established a relationship, which evolved into a partnership, with the California Leafy Green Marketing Agreement (LGMA) organization. On my first visit to LGMA, I met key staff members and observed a mock audit. We had good initial conversations. Scott Horsfall, CEO of LGMA, and I continued to talk and a second visit ensued, this time with individuals who had been ill with E-Coli from Leafy Greens. Everyone was a bit nervous, but it was a productive and even healing experience. We visited farms and processing plants, heard from farmers and shared a lovely meal outdoors with the farmers. On the last day, we sat in a room with tables configured in a large square and each person took turns introducing themselves, talking about why they were at the table, what roles they had in the leafy green business, and the visitors shared personal heart wrenching stories of illness and death from foodborne illness. There was not a dry eye in the room during and after this encounter. Every farmer vowed to do everything possible to prevent pathogens from making their way into the market place. This was a profound experience for everyone involved.
The following year, Scott proposed that STOP Foodborne Illness and LGMA jointly create a video for training purposes. That project came to life in the summer of 2014. It is a video and a project that LGMA and STOP Foodborne Illness professionals are deeply proud of and love to share with others (the video comes in several versions and is available in Spanish). Scott and I continue to speak about the partnership and look for additional ways to collaborate.
Food safety is about collaboration and finding solutions and preventing illness and death from foodborne pathogens. This week I spoke with a mother whose daughter died a year ago from foodborne illness (not from produce). I told her that I so badly wish that we could have prevented her beautiful daughter’s death and vowed to continue this important work. We are not there yet: Each of us must be completely committed to getting to a place where we don’t hear these stories. And we will get there by keeping the “why” at the forefront and continuing to develop critical strategies that reduce and work to eliminate the problem. Thank you to all who are dedicated to creating and sustaining a safe food supply and a special thanks to LGMA. You can see the LGMA video, “Video: The Why Behind Food Safety”, on our homepage.
This year is a big year for food safety at FDA. All seven of the FSMA rules have been finalized, and the first compliance date is right around the corner (compliance with the Preventive Controls for Human Food rule starts in September for large companies). Stephen Ostroff, M.D., just took the helm from Michael Taylor as the agency’s deputy commissioner for foods and veterinary medicine. And finally, FDA is taking a hard line in both improving the tools and methods used to detect outbreaks as well as working with the Department of Justice to prioritize enforcement actions against companies that introduce adulterated foods into the supply chain.
Yesterday Ostroff provided an update on FDA’s recent initiatives and its plan of action to achieve success in FSMA implementation and pathogen detection at the IAFP annual meeting in St. Louis. Ostroff highlighted several tenets of FSMA:
Keys to FSMA success will be dependent upon achieving high rates of compliance
Domestic and import parity
Education before and while regulating (establishment of training and education networks)
Taking a risk-based approach to inspection and planning
Partnerships are critical
FDA’s Stephen Ostroff will be the opening keynote at the 2016 Food Safety Consortium, December 7 in Schaumburg, IL. LEARN MORE
Industry can expect three more rulemakings as required by FSMA in the areas of lab accreditation, a reportable food registry and product tracing. In addition, FDA is working on guidances related to the preventive controls, produce, and foreign supplier verification program rules. “We’re tantalizingly close so stay tuned,” Ostroff said.
Expect to see more program alignment with the Office of Regulatory Affairs as well. The inspection and compliance staff will be trained as specialists and there will be horizontal integration of programs between field activity and agency headquarters. Although the next fiscal year will be a transition year, Ostroff is hopeful that changes that need to be made at the agency, along with program alignment, will be in place by fiscal year 2018.
Other notable actions at FDA over the past year include:
In response to the OIG’s conclusion that FDA’s food recall program is not efficient or effective, the agency is ramping up its use of the strategic CORE (Coordinated Outbreak Response and Evaluation) network in order to examine recalls that might not be moving as smoothly or quickly as the agency prefers. FDA is also leveraging greater application of whole genome sequencing (WGS).
GenomeTrakr network and WGS. More than 50,000 genome sequences have been added to the database (largely Salmonella). Ostroff called WGS a game changer that holds the opportunity to more quickly identify problems and detect outbreaks while they’re still quite small. In partnership with the CDC, FDA set up a successful module for WGS of Listeria and the agency hopes to expand the model for use with other pathogens.
Nutrition (Not just what consumers are eating, but how much of it): The move that declared partially hydrogenated oils as no longer GRAS with compliance required by 2018. The agency also issued a final guidance on menu and vending labeling in May, issued levels for arsenic in infant rice cereal, made determination for folic acid fortification in corn/masa, made revisions to nutrition facts labels that takes effect in 2018, issued a draft guidance on voluntary sodium reduction, and will continue to exam the terms “natural” and “healthy”.
Genetic engineering. FDA approval of GE salmon following one of the longest reviews in the history of FDA (20-year review), along with issuing voluntary labeling guidance.
Monitoring antimicrobial resistance through NARMS (National Antimicrobial Resistance Monitoring System). FDA will be collecting antimicrobial sales by species and, in cooperation with USDA, hopes to release farm-based data about antimicrobial use at the farm level.
Ostroff emphasized FDA’s strategic 10-year plan, released this year, pointing to public health as a first priority, maintaining partnerships as a key to success (including re-establishing overseas offices), continuing research as a foundation, and maintaining transparently.
Today’s workforce includes several different generations of employees and learning preferences. In part II of a Q&A series with Food Safety Tech, Laura Nelson, vice president of business development at Alchemy Systems, explains how food companies need to adjust to this new environment.
Nelson: Yes. Our employee demographics are continuously changing and, as a result, those changes impact the effectiveness of our training program. We have five different generations, and each has a learning preference—and some are directly opposed to each other. We have employees who like to learn by reading—baby boomers like things clearly spelled out like detailed sanitation SOPs. And then we have employees who would absolutely not want to read detailed protocols but prefer learning from their fellow colleagues and their supervisor – millennials who prefer micro-burst training and learning through interactions. [Based on] our research conducted in partnership with The Center for Research and Public Policy, when we asked employees their learning preference and what works best for them, the majority (57%) said on the job with a supervisor, and (56%) said on the job with a coworker. Clearly, learning beyond the formal classroom training is taking place every day. We have to ask ourselves how consistent is the food safety program learning experience on the plant floor? Are bad habits, incorrect behaviors and short cuts being reinforced by fellow employees? In a follow-up research question, we asked how much coaching employees receive from their manager and more than 43% of the responding employees said they rarely or never receive coaching.
Our challenge as an industry is to make sure employees are learning in a consistent way through their supervisors and colleagues. It speaks to the all-important role of the frontline supervisor and the fact that we have to arm them with the knowledge and skill to effectively mentor and coach their employees and give them time and the responsibility to do it. It’s important to include soft skills training for supervisors: How do you communicate and motivate employees? How do you encourage them in a way that [facilitates] improvement and reinforces appropriate food safety behaviors?
We also have data that says the quality of onboarding training is an area for improvement—over 20% of respondents rated the quality of their onboard training not good. Some companies are still executing the ‘one-and-done’ training where you spend a full day or two trying to do all the training that the employee needs prior to starting their new job. If an employee is bombarded with food safety training—all the different sanitation information, GMPs, operational controls, SOPs, industry regulations, etc.— by the time the employee leaves for the day, the reality is that they forget more than 80% of it within 30 days. So, our challenges extend beyond the employee learning preferences and where training takes place. We have to improve our training content to really meet [employee] education level, language, and learning preferences and provide in smaller chunks to improve knowledge retention. Our critical food safety messages need to be part of a continuous rolling thunder of communication, meaning you’re not trying to train all at once but rather are building a food safety awareness program, maybe through posters, shift huddle talks or digital signage. It’s the different things you can do that don’t require additional training time but impacts employees with multiple touch points to reinforce these key food safety messages.
STOP Foodborne Illness receives many requests to speak at conferences, trainings and meetings. I recently spoke at the Harris County Food Safety Summit in Houston, along with David, one of our Texas volunteers. David became ill from Salmonella after eating at a hospital. The event’s audience consisted of health inspectors, and restaurant owners and managers. It was a great crowd.
At this year’s Food Safety Consortium, STOP Foodborne Illness is holding a fundraiser and honoring heroes in food safety. LEARN MOREAt the United Fresh meeting, I participated on a panel with Rylee, a STOP Nevada volunteer, who spoke about her experiences as a victim of a foodborne illness. Also include on the panel were folks from The California Leafy Green Marketing Agreement to talk about our collaborative training video project. STOP Board Member Jorge Hernandez, also the Chief Food Safety Officer for Wholesome International, moderated the discussion. The video was played (available on STOP’s website). I was asked what I thought about competitive marketing advantage as it relates to food safety. To be honest, I don’t really think about that: STOP Foodborne Illness has an obligation to do what we can to prevent illness and death that stems from foodborne illness. We know that sharing personal stories makes a difference in training.
Now that I’m back in the office, our team has three requests, one for speaking and two requests from media to talk about food safety. We hear a lot about food safety culture these days, but actually taking the steps to facilitate, implement and monitor that change can be more of a challenge. We are reading about so many new technologies and practices related to food safety, which is great, but they must be accompanied by a company’s knowledge and commitment in order to be successful.
We will continue to contribute to the conversation. We are most interested in prevention and in solutions and like you, want to make a difference. We want to have fewer and fewer conversations with devastated family members about their experience with foodborne illness. Thanks again for all you do to create a strong food safety culture. How is your organization instilling a strong culture? Let us know how we can help.
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