By Lisa Lupo
Employee hygiene is an essential aspect of food safety with two critical components being prevention of contamination from workers’ hands and that from their clothes. But these are not always easy to control. How do you ensure that all personnel know, understand, and follow correct handwashing procedures and that their garments, themselves, don’t present potential contamination?
TRUST, BUT VERIFY. Handwashing prior to working with any food or even entering the food processing area is a standard in the food industry, but are your employees doing it right? According to the Food Code, every food or beverage plant is to have handwashing facilities that are adequate, convenient, and furnished with running water at a suitable temperature.
The primary way to comply with this rule is to have handwashing and, as appropriate, hand-sanitizing facilities “at each location in the plant where good sanitary practices require employees to wash and/or sanitize their hands.”
But even with handwashing stations located at the entry to food processing areas, it is difficult for plant managers to really know if employees thoroughly wash their hands every time or if they just go through the motions. Some large companies have automated sanitation stations, but most businesses provide “adequate, convenient” stations along with hygiene training and trust employees to comply.
While trust may work most of the time, observational studies conducted by University of Arkansas Distinguished Doctoral Fellow Jeffrey Clark have shown that trust, but verify, may be a better tact for plants to take.
Although the studies were conducted at a childcare facility, the results are applicable to any facility where handwashing and employee hygiene are critical, and for which the employees receive regular training. Additionally, Clark’s study is of particular interest because there are specific handwashing guidelines for child-care workers, and the facility has two-way observation mirrors and 24-hour video surveillance.
But, even knowing their actions could be on display any time, the workers were not always diligent in washing hands as frequently as required or in following CDC’s five-step handwashing procedure. (See “How Should You Wash Your Hands?”, page 25.) This, along with other findings of the study, he said, can provide a number of lessons for both the healthcare and food industries.
THE STUDY. To conduct the research, Clark randomly selected 25 hours of video from the facility’s recordings and coded it for compliance with handwashing guidelines. Negative findings were that:
- Increased training does not necessarily increase compliance. Whether observing the habits of supervisors or workers, degreed or trained, there was not much difference seen in compliance from a statistical standpoint, regardless of the amount of training or education the person had undergone. Thus, training alone does not necessarily make for more compliant handwashing.
- Trainers don’t always follow their own training. Somewhat surprisingly, even the teachers and caregivers who spent a lot of time teaching the children how to wash their hands didn’t always do it well or consistently themselves.
- A lack of understanding or thought about all the potential contamination points can be a key factor in the spread of bacteria.
APPLYING LESSONS LEARNED. With the purpose of the study being not only to find problem points, but also to develop solutions, Clark provided the following insights.
- A new environment can positively impact behavior change. Whether talking about a young child still developing behaviorally or an adult being engrained into a new environment, that fresh start provides the best opportunity for developing good habits. “A new environment makes habit change more conducive,” Clark said. The takeaway lesson is to train new employees on hygiene expectations immediately. “The earlier these habits can be established and enforced, the more likely they are to be followed,” he said. This also means that the high turnover rate of the food industry can be worked to its advantage, as new employees mean new opportunities to educate on good habits.
- The greater the relevance, the greater the compliance. It is very important to make hygiene training relevant and memorable to the person. With children, this often can be done by teaching with songs. While the same technique can be used with adults (e.g., singing the ABCs while you wash hands, or Smithfield Foods’ employee-written food safety jingles, bit.ly/2bAzcBL), using anything that is meaningful to your employees — incorporating a logo or cheer from local sports team, a catch phrase of your state or city, etc. can spark interest and make lessons more memorable.
- Personalizing training makes it “hit home.” As is also discussed in the Letter to the Editor which was received in response to the allergen articles of the July/August 2016 issue of QA, making it personal makes it more real. For example, norovirus can be spread through unwashed hands — which means that fixing or eating dinner or a snack without washing your hands, especially after using the bathroom, can make you or a family member violently sick. “Highlighting risks can play a role, but the more personal you make it, the more it hits home,” Clark said.
- Teach through example. One of the most interesting findings of Clark’s study was that those who spent a lot of time teaching the children how to wash their hands, and enforcing the handwashing, didn’t necessarily do it themselves. It is crucial that managers and supervisors set the example, not just expect compliance. Even if you are simply walking into the production area to talk with a worker, or passing through to another area, a worker who sees you walk in without washing your hands will think it doesn’t matter if he/she does that too. “What a manager does speaks volumes,” Clark said. “Don’t forget to wash your hands even when it seems inconsequential.”
- Ensure everyone understands all the potential contamination points. “It is important that everyone has a deep, acute awareness of all contamination points that could occur in a food facility from poor hygiene,” Clark said. For example, think about the times you have carried an item (pen, paper, cell phone, purse, etc.) into the restroom; set it down to use the facilities, then took it back out and laid it on the sink counter while you washed and dried your hands. Then picked it up to carry it back out. You’ve touched the item before you washed your hands, then touched it again afterward — potentially getting germs back on your hands. The same can happen from simply touching the face, nose, or even uniform, then going back to work on the food.
KEEPING CLOTHING CLEAN. While handwashing is a critical aspect of employee hygiene, it is not the only one to be considered. To determine best practices in another key area of hygiene, we asked COO of Aramark Uniform Services and Refreshment Services COO Brad Drummond about how workers’ garments can be a potential source of contamination and best practices in prevention.
QA. Why is uniform/garment sanitation so important in food/beverage processing plants?
Drummond. If employees wear dirty, damaged, or unsuitable outer garments, like a lab coat with buttons, it could introduce contaminants that could impact the product. It’s important for food and beverage processing plants to analyze all potential hazards, including what their employees wear on the job. Not only is it critical for food safety, but regulators continue to put more emphasis on identifying preventive controls.
QA. How can garments protect the workers (as well as the food)?
Drummond. Typical food processing garments are designed with features to minimize risk of product contamination, like having snaps or ties instead of buttons, knit cuffs, no pockets, etc. Requiring employees to leave soiled uniforms at the facility for washing also helps prevent them from introducing contaminants into their homes.
QA. How can a uniform service help a processor meet employee-apparel audit and/or regulatory requirements?
Drummond. Protective clothing requirements vary but, at minimum, a rental service that properly launders and delivers uniforms can help ensure employees have clean uniforms to wear every day. A provider that has a HACCP-based approach and third-party audit may provide documentation for processors to share with their auditors to help demonstrate their compliance with protective clothing and laundry requirements.
QA. What is most critical in the cleaning of clothing/uniforms worn in the processing area?
Drummond. It’s important to launder garments in a process that has quality control and verification steps. Garments should be washed in effective temperatures and formulas, and then covered in plastic to help prevent cross-contamination throughout the remaining laundry and delivery process.
QA. Are there any new/innovative technologies in uniform sanitation or the garments themselves?
Drummond. Advances in automated laundry technologies help ensure the wash formulas are consistent and accurate. Wash formulas are also improving in strength to disinfect the garments to help protect against a number of harmful organisms, including E. coli,Listeria and Salmonella.
QA. What else does the food/beverage processor need to know about employee hygiene and uniform sanitation?
Drummond. Processors should know how their garments are being laundered and delivered, including what chemicals and temperatures are being used and how the clean garments are protected from potential contaminants. A closely monitored process with quality control steps can help minimize cross-contamination and enhance their food safety efforts.
SUMMARY. Whether discussing handwashing, worker garments, or other employee hygiene, there are a lot of little things that can add up to big risk. But the more you know, the more you can implement education and preventive controls for sanitation.
The author is Editor of QA magazine. She can be reached at firstname.lastname@example.org.
Editor Lisa Lupo made the 3,000-mile journey from Ohio to Alaska to provide a first-hand view of doing business from “The Last Frontier.”
Photos by Taylor Balkom
t was early August in Alaska. The salmon had pretty much run their annual course up Ketchikan Creek, except for the last of the stragglers and those that had died in the attempt, leaving their decaying bodies in the creek and a pervasive smell across this southeastern Alaska city. It is a smell that may seem repellent to some, but it is the life-force of this “Salmon Capital of the World,” whose population of just over 8,000 swells by more than 900,000 each summer as a popular salmon-run stop on Alaskan cruise ship tours.
While it is this same seasonality that drives the production of seafood-processing facilities in Alaska, its schedule is much less predictable and its access less grand than those of the average 500 cruise ship dockings that dominate the city for five months — and for which the personnel of any tourist shop or hotel can tell you the daily schedule.
If only the fish were as reliable.
FISH SET THE SCHEDULE. As Trident Seafoods Vice President of Food Safety and Quality Assurance (FSQA) Kenny Lum said, the catch determines the processing schedule for the plant. As a vertically integrated harvester, processor, and marketer of seafood, Trident controls every part of the process from its fleet of 40+ vessels in the waters of Alaska that catch, catch-process, or transport the fish to its 12 shore-based plants that process and ship the fresh fish. And all seafood is shipped within 24 to 48 hours for direct sale or further processing in its plants in the Lower 48, China, Japan, or Europe.
As such, said FSQA Manager of Value-Added Products Jeff Hermanson, “We maintain a traceable chain of custody through the seafood supply chain.” And even in the plants located overseas, “there are Trident employees on the ground wherever we are processing,” Lum said.
But because its fish comes directly off the boats into processing, Trident has little control over the amount of fish that comes into the dock from day to day. Not only is this dependent on the number of fish in the waters at the particular time of year, but, Lum said, “A lot of it is about how much fish are allowed to be caught, based on fishing rights and quotas that are managed to ensure a sustainable resource. Then we have to process the fish rapidly to maintain quality, and get it out the door as soon as possible.”
To understand the vast variability of a day’s (or week’s or month’s) catch, take, for example, the contrast of my August salmon-scarce experience (described in the first paragraph) with that of the height of the salmon run in the same creek. As described by the Alaska Channel, “Thousands of fish work persistently to get up the creek, in an amazing sight that makes you wonder if you could walk across the water on their backs. At the height of the run, Ketchikan Creek is literally black with salmon.” (www.alaska.org/detail/ketchikan-creek-falls)
While the salmon run occurs “regularly” between May and September, it can peak anywhere in that time, with vast variation year to year, then virtually stop from October to April. Similarly, the availability of other fish is greatly reduced during the off-season, with the Alaska Department of Fish and Game completely closing off waters to fishing at times, and even short-notice closures occurring in-season by emergency order of the department. And even during open season, the catch may be limited by the fishing license or catch restrictions of the individual vessel.
So, all the fishing vessels, transporters, and processors can do is be prepared at all times during the season and shut down once the fish has run its course — which is exactly what happens at most of Trident‘s Alaska plants.
THE LAST FRONTIER. Adding to the business challenges of seasonal catch is the remote nature of Alaska, for which the state nickname is, aptly enough, “The Last Frontier.” Of Trident’s 12 Alaska plants, six are located on islands — of which the state has 2,670. While a land surrounded by water may be conducive to the transportation of fish, it is not necessarily as convenient for the people who live and work there. For example, the Ketchikan International Airport, on Gravina Island, is a ferry ride across the Tongass Narrows from the city of Ketchikan on Revillagigedo Island. The ferry runs on the quarter or half hour, and with the 2005 rescinding of funding for a bridge across the Narrows (which has become known as “The Bridge to Nowhere”), the ferry provides the only access between the city and its airport — unless, of course, one chooses to charter a private boat or one of the many seaplanes that tour visitors around the island and its Tongass National Forest.
It also doesn’t help that Alaska is both the largest and the most sparsely populated state in the U.S., which means limited availability of workers.
So, how has a business the size of the family-owned Trident Seafoods, which was founded by Tennessee-native Chuck Bundrant in 1973 with a single fishing boat, overcome the challenges of this “Last Frontier” to grow into the largest seafood company in the U.S., processing 500,000 metric tons of fish each year and generating nearly $2 billion in annual revenue?
By emulating the pioneering spirit that brought Bundrant to Alaska those 40-some years ago and allowing the nature of Alaska to control its processes and growth rather than attempting to control Alaska.
PIONEERING INNOVATION. Since the build-ing of its first vessel in 1973, funded by a partnership of Bundrant with “two other like-minded crab fishermen” Kaare Ness and Mike Jacobson, the company has invested in innovation. That first 135-foot Billikin was the first to have onboard cookers and freezing equipment, so that the catch could be processed as soon as it was pulled out of the water. Though its vessels are now larger and more modern, Trident continues this process today, with much of its fish caught, prepared, and frozen onboard within minutes of capture.
To enable this, the Trident fleet includes catchers, catcher-processors, floating processors, tenders, and freighters.
- Catcher vessels may catch any of virtually all the commercial species common to Alaska and the North Pacific, including king and snow crab, salmon, halibut, pollock, rockfish, pacific cod, flounder, and sole.
- While floating processors receive fish from the catchers and process it at sea, catcher-processor vessels both catch and process the fish, with the purpose of all at-sea processing vessels (or “factory trawlers”) being to bring the processing step as close as possible to the resource so the fish are frozen only once between catch and consumer, enhancing the quality of the finished product. The primary target species in Alaska is Pollock, which makes up the waters’ greatest biomass. Caught primarily in late winter and summer, it is filleted and frozen in blocks on these boats then shipped to a Trident or Trident-customer land-based facility for further processing. In the spring and fall, the ships and crew move down to the Pacific Northwest for fish such as Pacific Whiting, which is processed into surimi (imitation crab sticks). And when not engaged in harvesting at either area, the vessels are in the shipyard undergoing repair and maintenance, and getting ready for their next season.
- Tenders transport the caught and/or processed fish to the Alaska plants for further processing and/or packaging, and as deckhand Tim Steiner stated, act as a sort of “24-hour gas station and mini-mart” for the crews of the catching and processing boats. As the tender aligns itself with the fishing vessel to gather in its catch, the crew of the vessel will cross to the tender themselves to check out and make purchases from the tender’s pantry and freezer which is filled with everything from paper goods to lettuce to steaks, do laundry, take showers, and offload their garbage. While this is happening, the fish are being sucked out of the hold of the fishing vessel into that of the tender, going through a sorting and weighing process until the tender’s three holds are filled. Once everything is completed, the fishing vessel heads back out to sea to catch more, and the tender begins its trip back to the Trident dock to drop off the fish, get any needed service, and restock the pantry. Altogether, Steiner said, a round trip can take nine to 12 hours depending on the tide. The four or five crewmembers of a tender will generally live aboard for about three months at a time.
- Freighters support the processing vessels and land-based facilities, transporting freight to Alaska and Washington.
AN ALASKAN OPERATION. Representative of Trident’s shore-based Alaskan operations, the Ketchikan facility operates only during the season — three to five months of the year. And even when in season, the plant may or may not be in operation depending on the catch. As evidence of that, the plant had expected a catch to come in the night before my August visit, which would have put them into full operation. But an at-sea delay meant the catch would not come in until the evening, leaving much of the equipment and workers off for the day.
And in a Trident seafood plant of Alaska, that is simply the way of the world, as are the dynamics and demographics of the workforce, of which there were about 450 for the 2016 season. Before the season begins each year, Trident assembles its workforce, comprised of residents, university students, and many international workers primarily from Mexico and the Philippines, to travel to Alaska to work at the Ketchikan plant. Trident not only pays the workers’ travel costs, but provides housing and meals for all workers through the season. While this is of benefit to the workers, many of whom come back year after year and recruit family members as well, it also provides an on-site crew, so the plant can quickly begin operations when a catch arrives.
With only a radio call to alert the plant that fish are on the way into the dock, the first step when a tender arrives at the Ketchikan dock, carrying 150,000 to 300,000 pounds of fish, is a quality control check. The fish will be inspected, the temperature measured, and reports passed along. “We have a compensation program for the fishermen. If they have maintained the fish at 350F or less, they get a bonus,” said Plant FSQA Manager George Vigil.
Then the caught salmon will be pumped out of the hold and sorted by species (primarily pink, sockeye, and chum), with the amounts of each varying by season. Once off the boat, the plant process begins with the fish placed in tanks of refrigerated sea water to control the first wash of the fish. Water temperature is closely monitored, and the fish may be held in this tank for minutes up to a day.
If not already done on a processing boat, the head is cut off, the guts removed, and the salmon eggs (roe) pulled out and separated from the viscera to be processed in the egghouse. The viscera are not discarded, however, they are simply separated to be used in fish oil, meal, or other byproduct. “We use everything; nothing goes to waste,” Vigil said. Because the roe is a ready-to-eat (RTE) food, its operations are completely separated from the cannery and fillet operations, following the more intensive RTE guidelines with increased ATP environmental swabbing, and a dedicated brining line — through which the eggs travel for exactly 45 minutes for curing. The vacuum-packed eggs then go through a metal detector and into a freezer to be shipped out. Altogether, it will have been only 24 to 48 hours from the time the boat docked with the fish until the packaged roe goes out the door.
As the roe is being processed in one part of the plant, the fish is being filleted, skinned, sorted by size and quality, and put into totes to be iced down for 24 to 48 hours. This is done, in part, to let it age as needed to remove the pin bones.
THE CANNERY. As one of the largest cannery operations in Alaska, the plant has 12 lines on which it processes RTE canned salmon in four sizes: quarter-pound, half-pound, one-pound, and four-pound cans — there are only three companies in Alaska that produce four-pound cans.
But because a catch had not come in, the workers were conducting the once-a-season recanning operation of underweight cans. The process is labor intensive, so cans are brought in from all of Trident’s Alaskan plants so the work is consolidated into a single location a single time each season. Each can is manually opened by a worker; the contents are poured into a new can and weighed. The new can is then sealed, cleaned and coded — with both an ink stamp and embossing, because the oiliness of the fish could cause rub-off of the ink.
Whether undergoing canning or recanning, cans are frequently visually examined as CCPs to ensure container integrity. Once the cans are sealed, they undergo a retort cook step, with validation through colored tags — purple changing to light green and white stripes turning to black indicating that the cans were subject to the steam process and had not bypassed the retort.
Continuous recording charts and manual records are meticulously reviewed to verify all product was cooked for the proper time at the proper temperature. Seam checking is also a CCP, with the facility utilizing a seam scope that takes electronic images of the seam cross-section to validate its overlap and show any wrinkling as an indication of tightness. Another FSQA function is monitoring weight control. To ensure accuracy and regulatory compliance, all scales are recalibrated and batteries checked on a daily basis.
Although the canned salmon is a finished product, individual cans are labeled offsite, so the cans leave Ketchikan on pallets as unlabeled “brite stack” with pallet tags carrying the information necessary for full traceability. As an exception to FDA regulation, canned salmon is allowed to be shipped unlabeled to offsite warehouses because Alaska salmon canners participate in a unique voluntary cooperative agreement between FDA, industry, and the Seafood Products Association (SPA), the internationally recognized thermal processing authority. The agreement includes the requirement for every lot of canned salmon to undergo sensory evaluation and additional container integrity screening when labeled at the offsite warehouse.
THE LOWER 48. In addition to its Alaskan vessels and processing operations, Trident has six processing plants in the Continental U.S. — in Washington, Oregon, Minnesota, and its newest in Georgia. “We needed a presence on the East Coast because about 70% of battered and breaded product is sold on the East Coast,” Hermanson said. So, to see the next step in the source-to-plate process, we continued our journey along Trident’s operations at two Seattle-area plants: the Anacortes “value added” production and Everett smoked fish facilities.
One of the primary products made at Anacortes, Trident’s ultimate fish sticks, are cut from whole Pollock fillet (not minced fish) which were frozen into “head-to-tail” blocks on one of its factory trawlers or Alaskan shore facilities and shipped south. At Anacortes, the fish block is removed from its cardboard container and sliced horizontally then vertically into strips, while maintaining its frozen state throughout. The sticks are battered and breaded and par-fried to be shipped to retail. At Anacortes, a number of other value-added products also are made from a variety of fish species, such as cod, salmon, tilapia, and mahi mahi, some of which are made into burgers. The Anacortes plant has three lines, all of which are on wheels, so they can be reconfigured daily. This is both to enable best fit for the intended production and for sanitation purposes. The lines are wheeled out each night, the area and equipment completely cleaned and sanitized, and the equipment brought back in the next morning. The only permanent fixtures are the fryers, freeze tunnels, and packaging lines.
In addition to its three CCPs — metal detection, batter maintaining temperatures below 500F, and label verification for allergens — the facility is transitioning to a custom all-digital data-management system. With its real-time access and monitoring, the data can be viewed anywhere in the system, and will enable the facility to go paperless within the next year.
The Everett facility produces cold- and hot-smoked perishable salmon products and retort smoked salmon non-perishable products, with its smokehouse operating 24 hours a day year round, and the plant producing both retail and foodservice smoked-salmon products along with industrial byproducts that will be further processed into human or pet products. The CCPs at Everett are the fish dry curing or wet brining, smokehouse temperatures to control Clostridium botulinum and vegetative pathogens during hot smoking, cooler temperatures, metal detection, and labeling of allergens and handling statements. Hot-smoked fish are maintained at a minimum internal temperature of 1450F for 30 minutes while cold-smoked must stay below 900F ambient throughout the cold-smoking step.
The plant is also highly focused on pre-requisite programs. “We are always doing environmental testing and looking for niches in order to be proactive. Our pre-requisite programs are the cornerstone of our food safety system. As production has increased, the pre-requisite programs have increased to offset the increased risk,” said FSQA Manager of RTE Foods Scott Thacker. “Our RTE food safety mantra is based on the risk of occurrence in relation to the rate of introduction or residence and rate of removal. Essentially our rate of microbial removal through pre-requisite programs (GMPs and SCPs) must be greater than the rate of microbial introduction; or residence equals reduced risk of pathogen occurrence.”
Throughout the day, sanitation and quality assurance visually monitor and verify the pre-requisite programs, and the plant’s environmental monitoring program verifies that the microbial levels are acceptable. “We choose to seek and destroy transient and resident microbial risks through extensive food contact and non-food contact environmental testing,” Thacker said.
SUSTAINING ALASKA. While sustainability is the cornerstone of the company’s long-term business philosophy, going back to that of its founder, Trident has been working to further these efforts over the last few years. “We optimize what nature gives us, utilizing every bit of it that we can,” Lum said.
As such, the company follows intense responsible-fisheries-management practices in Alaska and is very careful about ensuring its practices are sustainable. “There is a minimum amount of the product that goes unused,” Lum said. “We know there is not an unlimited supply.”
To ensure waste is minimized as much as possible, the company invests in research and development aimed at extracting every bit of value from the fish, and it has been diversifying its markets to create better use of the byproducts, such as for fish meal and animal feed and food.
TRIDENT FOOD SAFETY. “There is no ‘budget’ for food safety; meaning we spare no expense to produce safe food,” Lum said. In addition to strong internal food safety systems, Trident participates with industry associations on food safety initiatives that go well beyond fundamental regulatory requirements. For example, Trident participates in the National Fisheries Institute (NFI) RTE task force, focused on sound science-based pathogen control strategies.
As part of the voluntary industry, FDA, SPA cooperative agreement previously mentioned, Trident also works directly with FDA as a participant in the Salmon Control Plan, through which a sample of every lot of canned salmon out of Alaska is examined by the SPA sensory team, with the results reported back to FDA. The samples are tested for quality and compliance and the reports provide support documentation for certification of canned salmon export shipments.
All Trident fish is inspected thoroughly head to tail, and all processes are continuously monitored through GMPs and seafood HACCP, Lum added. In addition to regulatory compliance, all Trident plants participate in a number of voluntary inspection programs including those of the SPA, National Oceanic and Atmospheric Administration (NOAA) Seafood Inspection Program, and National Fisheries Institute (NFI). Most of its plants are also GFSI certified, including its three catcher-processor vessels — the first vessels to achieve BRC certification in the food industry.
NORTH TO THE FUTURE. From its founding on the 135-foot Billikin in the pristine waters of Alaska to its current status as the largest vertically integrated seafood company in North America, Trident Seafoods has held to the philosophy by which Bundrant founded the company, focused on respect for the sea and its resources: “working toward sustaining a thriving and abundant ocean for generations to come ...
“Because we are fishermen at our core, and we have a bond with the ocean — when it prospers, we prosper too.”
The author is Editor of QA magazine. She can be reached at email@example.com.
The first of the compliance dates for FSMA is in the books, and with it came midnight-hour reprieves for some through extended deadlines, relief for others in the form of five chapters of draft guidance, and questions remaining for many with FDA’s promise of nine more guidance chapters to be published at some point and modified farm definitions to be considered.
EXTENSIONS AND DEFINITIONS. Of the seven compliance date extensions that FDA made, four focused specifically on farms, with extensions made to align the dates for farms conducting similar activities as under the Produce Safety rule and/or included in FDA’s plan to consider modifying the definition of a farm, i.e., to address ownership issues, “coloring” activities, and cotton-industry ginning concerns.
As such, it has set the earliest compliance dates as being late January 2018 for certain operations that:
- Would be secondary-activities farms except that they do not meet the ownership criterion, and thus are under the preventive controls rule.
- Color raw agricultural commodities.
- Are solely engaged in cotton ginning that provide products without further processing for use as animal food.
With its deadline extension for secondary-activities farms, FDA has provided some desperately needed clarification on manufacturing and processing versus farm activities, i.e., “Am I a farm or am I not a farm?”
That is, a secondary-activities farm qualifies even if it does not meet the ownership criterion if the operation:
- Is not located on a primary production farm;
- Is devoted to harvesting, packing, and/or holding of raw agricultural commodities;
- And is under common ownership with the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested or packed, and/or is held by the operation.
However, as even FDA indicates in its plans to consider farm definition modifications, there are still a lot of unanswered questions. My advice to those struggling with this is get started anyway. Don’t sit out the extended timeframe waiting for FDA’s definition; instead, pick a lane that you can justify and makes sense based on what has been published, then plan to make adjustments as needed when we hear more from FDA.
Other extensions granted by FDA were a two-year extension for provisions that allow for modified requirements or exemptions if a hazard is validated as being controlled downstream, and two years for the importation of food-contact substances under the FSVP rule. The extended time of both also provides time for FDA to consider the best approach to address feasibility concerns.
Additionally, FDA created a single compliance date, September 17, 2018, for facilities producing Grade “A” milk products to comply with all requirements, and clarified that covered farms under the Produce Safety rule must begin sampling and testing untreated surface water no later than the compliance date (January 26, 2018). FDA clarified that it does not mean the two- to four-year testing must be completed by that date. (For the full rule on extensions and clarification, visit bit.ly/2cGKQwq.)
For some, these extended compliance dates will be helpful. My view is that at least some of the deadline extensions, such as that for the letters of assurance, are a reflection of FDA really not knowing how to enforce the requirements.
But an extension is an extension whatever the reason.
THE FOOD SAFETY PLAN. With the food safety plan (FSP) being the heart of the Preventive Controls rule, which is, essentially, the heart of FSMA as a whole, FDA devoted the first chapter of its 14-chapter draft guidance to this. Not only does it provide guidance on the writing of the FSP, it compares the FSP with HACCP, drawing out the similarities and differences. (In this article, we address only the FSP writing; for a discussion of FSP vs. HACCP, see my online article, FDA Begins to Clarify the PC Rule [bit.ly/2d8Aysp].) However, be sure to understand that a FSP is not the same as HACCP.
FDA defines the FSP as consisting of “the primary documents in a preventive controls food safety system that provides a systematic approach to the identification of food safety hazards that must be controlled to prevent or minimize the likelihood of foodborne illness or injury."
So, what does that mean in application? The FSP is a collection of written documents — that can be of any format and consolidated in a single location (e.g., a binder or folder) or tabulated then located in various sites in the plant. But, either way, it must include a hazard analysis of all ingredients and process/manufacturing steps to identify hazards requiring a preventive control; what the preventive control(s) are for each, along with a recall plan; and the procedures for implementation monitoring, corrective action, and verification.
Additionally, the analysis must be written, even if you have not identified any hazards that require preventive controls; and the FSP must be signed and dated by the owner, operator or agent in charge of the facility once completed and whenever modified.
FDA also makes it clear that the FSP is intended to only cover hazards that are capable of causing illness or injury, not simply “undesirable” conditions (e.g., insects, hair, filth, spoilage, etc.) unless any of these directly affect food safety. However, such hazards do need to be analyzed and the hazard analysis document included in the FSP.
There also is some discussion of the “preventive controls qualified individual” (PCQI), including the fact the FSP is to be developed by a PCQI with the education, recognized training, and/or experience to develop and apply a food safety system. However, it leaves it to industry to consult the rule and/or connect with the Food Safety Preventive Controls Alliance for complete information.
The FSP must be reanalyzed at least once every three years, and the applicable portions reanalyzed anytime there is a system or equipment change, new information about applicable potential hazards, an unanticipated food safety problem; a preventive control, combination of preventive controls; or the FSP is found to be ineffective. (For the complete Draft Guidance, link to http://bit.ly/2cGMjmc.)
STILL NOT READY? If you have found that the compliance date has come and gone and you are still not ready, your first step should be to move compliance to the very top of your priority list and get all applicable persons involved to get it moving. The second step should be to take a close look at all the compliance dates that apply to you, including the new extensions, and prioritize based on those.
Your third step should be to not panic or let your team get overstressed. With the new mandates, the complexity of some aspects of the rule, and the late issuance of any guidance, a lack of absolute compliance may be understandable if FDA shows up at your door. I would hope that the inspectors will exert a lot of enforcement discretion, and realize we are all in a learning curve and are in this together, but you do need to ensure you know the mandates of the rule and exactly what applies to you; be in compliance as much as possible; and be prepared to show FDA what you do have, explain exactly what you don’t have, why you don’t have it, and what you are doing to have it ASAP.
With all that said, you also need to remember that the compliance date is the date by which compliance is required. So you can’t sit back and relax thinking partial compliance is good enough and FDA is unlikely to show up at your facility right away anyway. FDA is knocking on someone’s door today.
David Acheson is Founder and CEO, The Acheson Group.
The controversy went briefly viral, then, like the “Food Police” section of the fact sheet itself, faded into the virtual infamy of the Internet as the next political controversy took over the headlines. While QA generally steers away from politics, and this column is not meant to indicate a partiality for either side of the Presidential race, the brief moment that FDA and food safety took on an international spotlight was significant if only because regulation vs. self-policing has been a long-standing industry controversy, with QA coverage nearly as far back as we’ve been in existence (e.g., “Can We Self-Police?” August/September 2008; “Viewpoint: A Merging of Camps,” March/April 2009.)
In case you missed it (which is, in fact, rather likely), the controversy was stirred by a September fact sheet posted online by the Trump campaign, which included a statement that, among the “specific regulations to be eliminated” in his economic plan would be “The FDA Food Police, which dictate how the federal government expects farmers to produce fruits and vegetables and even dictates the nutritional content of dog food. The rules govern the soil farmers use, farm and food production hygiene, food packaging, food temperatures and even what animals may roam which fields and when. It also greatly increased inspections of food ‘facilities,’ and levies new taxes to pay for this inspection overkill.”
But don’t try to go to the campaign site and find it. Soon after its publication, the fact sheet was deleted, amended, and reposted without the FDA references … but not before the page was picked up, highlighted, and tweeted — and retweeted over 700 times.
It is that original Tweeted screenshot that generated headlines ranging from MSNBC’s “Trump’s FDA plan should raise concerns for Americans who eat food” to Forbes’ “But Donald Trump Was Right — Heinz Ketchup Is Why We Can Kill FDA Food Regulations.” While the majority of responses decried the elimination of FDA policing and rules, there were those who saw the statement as having some validity.
A New York Times article provides some balance, citing the passage of the Food Safety Modernization Act (FSMA) as being in response to the 2010 peanut Salmonella outbreak, noting the more recent cantaloupe and ice cream Listeria outbreaks, and citing former FDA Deputy Commissioner for Foods Michael Taylor as saying, “Eliminating FDA’s food safety role would make more consumers sick, destroy consumer confidence at home, and damage American competitiveness in global food markets.”
As a counterpoint, the article also cites Alabama Republican Senator Jeff Sessions as saying, “In Washington, if you propose to pull back any regulation that has a good title, like food safety, then somebody says you want to poison the American people, and so forth. But if it can be established that they are not really beneficial, oftentimes the regulations can actually make things more unsafe.”
An article that may be of even greater interest to the food industry is that by Forbes contributor Tim Worstall of the UK. Countering a Think Progress fact-sheet response that Heinz Ketchup’s market dominance is proof that regulation is needed, Worstall writes, “Regulation, in general, followed the clean up of the food marketplace, not caused it. And those big brands that are still with us from those unregulated days are the ones which killed rather fewer of their customers back then. That is, the general free market story, that manufacturers tend not to want to kill their customers, is the correct one.”
And with Heinz being the leading brand long before the food regulations were adopted, Worstall states, “Heinz Ketchup is not proof that we need food regulation. It’s that markets, brands and reputations already provide regulation for us.”
Perhaps rather than taking down the post at the first sign of dissension, the campaign should have given an explanation for the stance. I’m certain it’s a position the industry would be interested in hearing.
What are your thoughts?
The author is Editor of QA magazine. She can be reached at firstname.lastname@example.org.