Covered facilities must establish and implement a food safety system with a written food safety plan that includes hazard analysis, preventive controls, and the oversight and management of preventive controls (this encompasses monitoring, corrective actions and verification).
The “farm” definition has been clarified to include two types of farm operations, primary production farm and secondary activities farm. Such farms that conduct produce activities will also have to comply with the Produce Safety Rule (to be finalized at the end of October).
A more flexible supply chain program, with separate compliance dates.
Update and clarification to CGMPs.
This year’s Food Safety Consortium conference will feature first-hand perspectives from FDA and USDA on FSMA implementation and enforcement. REGISTER NOWCompliance dates range between one and three years depending on the size and type of business. Several guidance documents will be created by FDA in an effort to further help companies with compliance, including on hazard analysis and preventive controls, environmental monitoring, food allergen controls, and the validation of process controls.
The Federal Register will publish the 930-page document on September 17. In the meantime, the pre-publication version can be viewed here.
CGMPs established for the production of animal food, taking into account the diverse types of animal food facilities.
Covered facilities must establish and implement a food safety system with a written food safety plan that includes hazard analysis, preventive controls, the oversight and management of preventive controls (this encompasses monitoring, corrective actions and verification), and a recall plan.
A more flexible supply chain program, with separate compliance dates.
The “farm” definition has been clarified to include two types of farm operations, primary production farm and secondary activities farm.
Feed mills associated with farms (vertically integrated operations) are not covered.
As with the preventive controls for human food, FDA will be creating guidance documents that address CGMP requirements, hazard analysis and preventive controls, human food by-products for use as animal food, and a small-entity compliance guide.
The Federal Register will also publish this 666-page document on September 17. The pre-publication version can be viewed here.
At this year’s Food Safety Consortium Conference, the industry will have the opportunity to hear directly from FDA and USDA on what companies need to know to be FSMA compliant and how the agency will be enforcing the regulation. Michael Taylor, JD, deputy commissioner for foods and veterinary medicine at FDA, will delivery the opening plenary presentation, which will be followed by an “Ask the FDA” Q&A town hall meeting.
From sanitation and processing to testing and analysis to transportation and imports, government requirements of companies in the food industry are changing. Many companies are already prepared for the transformation that FSMA will bring. Within food testing and analysis, expectations will be higher than ever. Companies should be able to more accurately and rapidly identify contamination in order to take immediate action. What are some of the biggest concerns in testing and analysis? What changes can we expect? In a roundtable discussion with Sample6 executives, Michael Koeris, Ph.D., founder and vice president of operations, Tim Curran, CEO, and Jim Godsey, vice president of research & development, share their perspective on the hurdles that industry is facing and how innovative technology plays an important role in the future of food safety.
Key trends:
Focus in testing shifts from not just testing and recording data, but also analyzing and communicating results. Having data analysis and reporting skills will be a critical function for the next generation of food safety professionals.
Be proactive, not reactive. If you’re finding problems at the finished product level, it’s too late.
The need for stronger partnerships between industry and government, especially relating to providing industry with the tools to effectively gather and analyze data in a timely manner.
Food Safety Tech: What are the current industry challenges, especially related to advances in pathogen detection technology?
Tim Curran, CEO of Sample6
Tim Curran: When I look at food companies and food safety managers, [their jobs] have become harder to do well, instead of easier. The environment in which they’re working is more challenging, and the pressures are increasing. There’s more regulatory scrutiny, whether we talk about FSMA or the regulatory environment [in general], and there are more testing and inspection [expectations].
Second, the nature of the foods that we need make for the U.S. population (and I think it is a trend around the world): Ready-to-eat products. We’re producing products that are more convenient for families where they won’t necessarily have a cook step down the road. The kinds of foods in demand have a higher risk profile.
Third is the globalization of food supplies. Raw materials are coming in from all different directions, and there is an increasing number of shipping points. That creates more pressure, and from a food safety perspective, that is a bad thing.
“It is okay to find positives for Listeria or Salmonella in the appropriate zones that are far away from food contact surfaces. It is inconceivable to have a plant that has no actual bacterial organisms living there.” -Michael KoerisFinally, there’s social media. There’s a lot of scrutiny from the public. Information around any kind of fear or recall is rapidly disseminated.
These factors add up to higher pressure, a higher bar, and a harder job to accomplish—and the tools and methods available to keep the plant safe and food safe are not keeping pace.
Although I think food plants want to test more at the point of contamination, it’s just not possible. Unless they have a sophisticated lab, most food companies ship out samples because enrichment is required. As a result, they’re getting feedback on the safety of their plant and food in two, three, or four days, depending on where they fall as a priority to that outside lab.
Jim Godsey: With FSMA, testing is decentralizing from the larger lab, which is typically staffed with experienced personnel, to the facility where those personnel don’t exist. Having a test with a workflow that can be easily accommodated by someone with a high school education is absolutely critical for the field.
Michael Koeris, Ph.D., founder and vice president of operations
Michael Koeris: Visibility of data is generally extremely poor, because many people touch individual data points or pockets of data. The hand-off between the different groups is usually shaky, and the timeliness of delivering data to the operators has been a huge issue. This has been an opportunity for us: Our control offering is an operating system for environmental control. It’s an open system, so it accepts both our data and other people’s data, enabling visibility across an entire corporate infrastructure. Plant managers and other [users] of these systems can generate timely reports so they can see what is happening on a daily basis.
FST: In considering professional development, what skills are necessary to ensure that employees will be well equipped to address the issues discussed here?
Godsey: The role of the food safety manager becomes a much more critical and challenging role. To support that, they need better tools; they need to know with a high degree of confidence that their facility has been tested, that the testing was done at the proper times and intervals, and that the data has been analyzed in a timely manner. It’s not just assay/analysis [or] reporting results anymore; it’s the holistic review of those results and translating that [information] into whether or not the plant is safe at that point in time.
Koeris: The persona of the food safety manager is changing. They need to see themselves as the brand protection manager. If you have food safety issues, your brand is at risk. We need to empower the food safety manager at the local level to act, remediate and change processes.
Jim Godsey, vice president of research & development
There also has to be fundamental change in the industry in how results are viewed. Not all tests are created equal. It is okay to find positives for Listeria or Salmonella in the appropriate zones that are far away from food contact surfaces. It is inconceivable to have a plant that has no actual bacterial organisms living there. This is not a pharmaceutical production facility. Setting the wrong goals at the corporate level of zero positives disincentivizes operators to not look hard enough. You have to actually understand the plant and then make sure that you’re safe with regards to your control plan.
FST: How do you expect the final FSMA rules and implementation process will impact industry?
Koeris: Most of the larger food players are already doing what FSMA mandates or will mandate. The medium and smaller processors will have to adapt and change. They have to implement better standards and more standards, more surveillance, and implement more rigorous processes. The [key] is to help them do this on a tight budget.
FSMA has increased awareness of food safety across the supply chain. It is still focused on the processors, but we know it doesn’t stop there; it doesn’t stop at the distributor or the retailer. Food safety has to be throughout that supply chain.
Having an understanding and awareness of all of the challenges that exist downstream—that will [lead to] the real innovation and increase in foods safety.
UPDATE: September 9: According to the CDC, 341 people have been reportedly infected with Salmonella from 30 states. Since September 3, the number of cases has increased by 56. Two deaths have now been reported (California and Texas). Andrew & Williamson Fresh Produce has voluntarily recalled all cucumbers sold under the “Limited Edition” label (between August 1 through September 3, 2015).
More information has been posted on the CDC website.
Across 27 states, an outbreak of Salmonella Poona linked to cucumbers grown in Mexico has led to one death and 53 reported hospitalizations, according to FDA. The agency released an update on Friday with the latest figures and information related to the outbreak and the product.
The product:
Cucumbers supplied by Andrew and William Fresh Produce of San Diego
Cucumbers grown in Baja, Mexico
Referred to as a “slicer” or “American” cucumber
Shipped in black, green, yellow cartons that read “Limited Edition Pole Grown Cucumbers”
The Salmonella outbreak (as of 9/3):
Where: Alaska (8), Arizona (60), Arkansas (6), California (51), Colorado (14), Idaho (8), Illinois (5), Kansas (1), Louisiana (3), Minnesota (12), Missouri (7), Montana (11), Nebraska (2), Nevada (7), New Mexico (15), New York (4), North Dakota (1), Ohio (2), Oklahoma (5), Oregon (3), South Carolina (6), Texas (9), Utah (30), Virginia (1), Washington (9), Wisconsin (2), and Wyoming (3)
Date range: July 3 to August 26, 2015
1 death
53 reported hospitalizations
Additional details are available on FDA’s website, and the agency will provide an update when new information is available.
As with any potential health hazard related to consumption of a food product, FDA is advising consumers not to eat the cucumbers. They are also urging restaurants to ask their suppliers what company supplied their cucumbers.
In June FDA officially deemed the use of partially hydrogenated oils (PHOs) as unsafe, or technically, not generally recognized as safe (GRAS). The use of PHOs has been debated for more than a decade, and as a result of FDA’s latest ruling on PHOs, food processors must remove these ingredients from their products within three years.
From preservatives to artificial sweeteners to natural flavors, the list of ingredients that go into processed foods can be quite extensive. Consumers are becoming more vigilant about what they put into their bodies, and FSMA will give FDA the authority to act immediately in instances related to safety. Does this mean that some ingredients could be in danger? The answer is yes, according to Jim Lassiter, president and COO of Ingredient Identity. “[Ingredients] are products that you literally take inside your body, and there is nothing more personal than that,” says Lassiter. Combine this simple yet fundamental fact with consumer awareness and the entrance of FSMA, and food and beverage manufacturers may be entering a new era of scrutiny.
Food Safety Tech: From an ingredients perspective, what challenges are the industry facing?
Jim Lassiter: Implementation of FSMA. Although it’s being implemented at a slower pace than Congress desired, and I believe slower than [FDA’s] original intent, that pace is accelerating. And while the increase in challenges related to the composition and manufacturing of products will be significant, FSMA will be an overall benefit to consumer confidence.
Consumer confidence. Whether the issue is bioengineered foods or disclosure of bioengineered foods through the business of trans fats, or just the general composition and healthful nature of foods. Slowly but surely, increasing consumer awareness of food choices and diet will have a significant impact. Regardless of the type of product, this is going to be universal and will increasingly play a role in decisions that food companies make during product development.
The unknowns. We don’t know what is coming around the corner, whether it’s positive or negative. A lot of effort is being extended within the food sector to discover the next big thing—whether it’s probiotics or prebiotics; addressing product reformulation in light of the elimination of trans fat [requirement]; or something that strikes out of the blue. That is always the most challenging aspect of the ingredients industry. Foods themselves, regardless of what country you are in, are cultural in nature; they are the most personal consumer good that you can obtain. As a result, our awareness as an industry of what we do to products must bear both of those pieces in mind. We have to recognize the cultural nature of food and simultaneously recognize the personal nature of products. As a result, we won’t necessarily have insights into the great unknown or the next big thing, but at least we will have the perspective necessary to deal with any unknowns as we move forward.
FST: In the coming year, what overall effect will FSMA have on food and beverage manufacturers related to ingredients themselves?
Lassiter: From an ingredients perspective, what’s going to happen is simple and straightforward. FSMA grants FDA the broad authority to assist and act in instances where there are issues with safety. That is, however, still nebulously defined and interpreted. So, there’s potential for FDA to suddenly make a determination that an ingredient is not safe or [that it] poses some degree of safety risk. FSMA authorizes FDA to take immediate action rather than [submit] a new process notification, etc. They will also have the authority to take immediate action in the case of violations of good manufacturing practices if the perception can be tied to any aspect of safety. FSMA stands for safety; that is the hinge point on which all of this occurs.
For example, with the revised good manufacturing practice for the manufacturing of food products coming out and the full implementation of HACCP across all food categories, it’s conceivable that FDA will take immediate action on inspection deficiencies in the food manufacturing realm. I think that’s one of the big issues. I don’t want to make it sound like the boogey man is out there, but it is a very real possibility. Ingredients themselves can suddenly be identified as unsafe. I don’t see that necessarily being a very radical reaction. The potential impact is more likely to be broad, but I suspect that at some point in time, there will be an ingredient that pops up out of a FSMA ruling that will suddenly be declared to be unsafe and [consequently] removed from market.
Second, I think the implementation of HACCP across all food categories will have notable impact, initially through common regulatory action (i.e., via inspection deficiencies reports, which are very common in terms of dietary supplement manufacturer inspections). I think you’ll see those becoming increasingly common in food manufacturing operations, because of the implementation of HACCP more broadly. The first round will be more likely for increased regulatory activity in food manufacturing inspections. If that message is not received and implemented rapidly, then the extension of FSMA is that [FDA] can shut down the plant without any due process whatsoever. That looms as part of the implementation. In terms of ingredients, you’re likely to see [some] that folks may not have previously thought about [as unsafe] identified as potentially hazardous. I’m not sure in what area it will occur, but I’m fairly confident that it will happen at some point in time.
Part II of Food Safety Tech’s conversation with Jim Lassiter takes a closer look at GRAS self declarations and the areas of confusion among companies.
According to an FDA alert, the agency has submitted the final preventive controls rules for human and animal food to the Federal Register. FDA notes it can take several days from the date of submission to final publication.
“The FDA is committed to sharing information about the final rules and how food facilities can comply as soon as we are able to do so.” The agency will be providing more information on the FSMA section of its website.
Next month Stewart Parnell, the former CEO of Peanut Corporation of America (PCA), is scheduled to be sentenced for his role in a deadly salmonella outbreak involving shipping contaminated peanut products nationwide. Parnell, who could spend the rest of his life in jail, was found guilty on 71 counts, including conspiracy, obstruction of justice and wire fraud. This landmark case sends a strong message about accountability to both industry and consumers, said Darin Detwiler, senior policy coordinator for food safety at STOP Foodborne Illness, at the IAFP 2015 conference in July.
“His actions resulted in technically more deaths than that of Charles Manson,” said Detwiler, who indicated that Parnell is still very much in denial over his role in the salmonella outbreak. “This might be one snapshot—one look at one person in one industry, in one business—but think about how many companies are out there [and] of this mindset—the idea that they’ll never get caught.”
Food companies should be held strictly liable when it comes to consumer safety, ensuring that they take preventive measures so that illness and death never happen. The sentencing of Parnell next month could set a precedent for how future cases involving companies responsible for foodborne illnesses and outbreaks are handled.
At this year’s IAFP 2015 conference, there was a lot of buzz surrounding food safety culture and employee behavior. Laura Nelson, vice president of business development at Alchemy, shares her insights on the importance of empowering employees. This is achieved through providing training that gives them the confidence to make immediate decisions on the facility floor.
“We have to own the fact that employees are the key. They are exposed to the product and they’re really the ones touching our food every day,” says Nelson. “And yet, we don’t do a really good job at training and measuring that effectiveness in their execution of the behaviors that we train them on, on the plant floor.”
In the following video, Nelson talks about what industry is doing right in food safety culture, and the areas in which improvement is needed moving forward.
With publication of the first set of final rules for FDA’s Food Safety Modernization Act (FSMA) expected any day now, food safety teams are busy strategizing as to how they are going to prepare for compliance and be “FSMA-ready” on Day 1.
Across industry, it is generally agreed that being certified to a GFSI scheme is a solid foundation for FSMA compliance. In a new three-part online series, “GFSI in the Age of FSMA: How GFSI Schemes Align With and Prepare You for FSMA”, the North American leaders of the three major GFSI schemes – SQF, BRC and FSSC 22000 – will discuss the following topics:
How certification to their scheme prepares a company for FSMA compliance in terms of alignment with:
Supplier Controls
Building a food safety plan
Migrating from HACCP to HARPC
Being audit ready all the time
Environmental monitoring … human & animal food rules … and much more
What changes to the scheme have been made (or are planned) to better align with FSMA
Gaps the leaders see in FSMA that are filled by their scheme
What companies who are, or plan to be, GFSI certified should be doing now for Day 1 FSMA compliance
(left to right) John Kukoly of BRC, Jacqueline Southee of FSSC 22000, and Robert Garfield of SQFI are the featured speakers of the GFSI series.
Food company teams working in Regulatory, Food Safety & Quality Assurance, Operations, C-Suite, Legal and other related positions in companies who are – or are planning to become – certified in a GFSI scheme are encouraged to attend one, two or all three sessions.
The series is being sponsored by SafetyChain Software with media partner Food Safety Tech.
As FSMA promises to increase the responsibility of food laboratories, companies must pave a path forward by working more closely with industry as a whole, government and non-government organizations, as well as with each other. This was the clear message relayed by Pamela Wilger , assistant director of global food safety at Cargill, at IAFP 2015.
“We consider a lab any person generating data,” said Wilger, who emphasized the “lab” is not just the room itself. Lab testing should not focus on a single narrow view (i.e., one test); companies should be efficiently applying their resources, considering both science and risk. “Non-science based testing can lead to conflicts between suppliers and customers and manufacturers and regulators, and destruction of wholesome product.”
Here’s where improvement is needed in food labs:
Disseminating best practices. “We don’t even share that [as an industry],” said Wilger. “We don’t have time to replicate the same work.”
Aligning international rules
Cooperating with national regulators, including local/regional entities.
Testing and improving compliance policies
Building consumer trust and confidence
Training/competency development. Finding the right people, and encouraging employee knowledge sharing
Being prepared for the next intentional economic adulteration
Palmer Orlandi, Ph.D., CAPT, U.S. Public Health Service Sr. Science Advisor in the Office of Foods and Veterinary Medicine at FDA, shared insights on how FSMA will affect lab responsibilities moving forward, with a focus on prevention versus reaction. The objective for lab capacity programs is to facilitate submission and acceptance of meaningful and actionable data to all regulatory agencies, he said.
Reset, expand and integrate: A need to focus on resources
Method performance and “fit for purpose”, harmonized standards
Large-scale focused surveillance activities; statistical significance, real-time evaluation of data generated
Real-time communications, bioinformatics, IT infrastructure, data-sharing platforms
Technology and innovation partnerships, including on an international basis
With the upcoming regulations right around the corner, the good news is that FDA is still on track to meet the FSMA deadlines for August (preventive controls for human and animal food). But as industry looks to the future of FSMA and its implementation, resources and funding will be a challenge. Michael Taylor, deputy commissioner for foods and veterinary medicine at FDA, continued this message (which he declared several months ago) at the 2015 IAFP conference in Portland, OR.
“We’ve been given a brand new mandate by Congress to do things we haven’t done before,” said Taylor, as he emphasized that FDA will be in a do-more-with-less resource-challenged state. FDA would need, over the five years following the enactment of FSMA, $580 million, said Taylor. Over the first five years, FDA has received about $162 million (through 2015). “2016 is the absolute crunch year for FSMA funding,” he said. President Obama’s budget request for FY2016 would provide $109.5 million.
The issue is that there simply isn’t enough funding to get it all done, or as Taylor put it, not enough money to “maintain momentum towards comprehensive implementation of the FSMA vision.” As a result of the funding limitations, Taylor said that FDA will be making “hard choices” and will be forced to prioritize the funding that it receives. He indicated that the agency will focus on preventive controls implementation first. But this leaves a potential for disruption due to the investments needed for implementing the produce safety rule and building a strong system for imports, which may pose the biggest challenge over the next decade, Taylor warned. While trying to remain positive, the deputy commissioner also maintained that he wanted to be transparent about the situation.
FSMA will give FDA the ability and technology to act in real-time when issues occur, but it will also require new skills and training, as well as a shift in culture. In November, Taylor will be the opening plenary speaker for the Food Safety Consortium Conference and will surely have more insights, as industry will be entering the implementation phase.
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