Tag Archives: inspections

FDA

FDA Finalizes Rule on Food Facility Registration

By Food Safety Tech Staff
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FDA

As part of FSMA implementation, FDA has announced a final rule, effective today, that will better protect public health by improving accuracy of the food facility registration database. The Amendments to Registration of Food Facilities will also help the agency more efficiently use its resources to conduct inspections and aid in a faster response to food-related emergencies.

The final rule adds provisions to the current regulations to codify certain provisions of FSMA that were self-implementing and effective upon enactment of the regulation, according to an FDA update. Provisions require:

  • Email address for registration
  • Registration renewal every two years
  • Registrations must have assurance that FDA will be allowed to inspect the facility at any time

Important dates:

  • Final rule effective July 14, 2016. Registrations must contain type of activity conducted at the facility for each food product category.
  • Requirement of electronic submission of facility registrations takes effect January 4, 2020.
  • As part of registration proves, food facilities must provide unique facility identifier (UFI) beginning October 1, 2020.

FSMA Raises Pressure on Pest Management

By Maria Fontanazza
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As with many areas in food safety, the future of pest management will place more emphasis on implementing a scientific approach and leveraging digital technologies. Food manufacturers and processors will rely more heavily on their pest management providers to be their eyes and ears to find issues within a facility that may have otherwise gone undetected and could lead to potential deadly outbreaks. “The pest control industry is always trying to control pests. But now the manufacturers are realizing that this [regulation] is pretty serious and people [could] go to jail,” says Ron Harrison, director of technical services at Orkin, LLC. “I think you’re going to find a much more scientific approach to pest control in food processing.” In a discussion with Food Safety Tech, Harrison shares insights on the changes (for the better) that FSMA is having on the relationship between pest management professionals and food manufacturers and processors.

Food Safety Tech: What are the biggest areas of concern surrounding FSMA and pest management? Are companies in the food industry prepared for compliance?

Ron Harrison: The big part about FSMA is that everything is now suspect in reference to food safety—from deliveries to storage to transportation on the backend; there’s a much more holistic approach. It has had a major impact on us—we’re doing more inspections on the front end, when the trucks [deliver] the raw ingredients, and we look for possible pests on the truck, rather than [inspecting] an isolated building.

The elevation has been that owners and managers realize that they’re going to be held responsible for potential food safety issues, and so they’re holding their pest professional at a much higher level to help be their eyes and spot potential problems to ensure compliance with safety issues. For example, take two situations that have come up in the last five years—the Peanut Corporation of America [Salmonella outbreak] and Blue Bell Ice Cream [Listeria outbreak]. In neither one of those cases were pests responsible for the problems. But questions came back to pest control professionals about why they weren’t making [the manufacturers] aware of leaking coming from the ceiling, etc. I think they’re looking for us to support their programs of food safety, not just ‘kill some cockroaches’ or prevent rodents from coming into [a facility]. Manufacturers are asking us to tell them what they’re doing wrong rather than us going back to them. I think there’s a better partnership moving forward.

The industry went from pulling out equipment and spraying [to control pests] to [the present] where it’s not uncommon for a microbiologist to take samples to find out not just if there’s a cockroach, but did it leave anything behind. I think you’re going to find the approach to pest control to be much more scientific.

FST: What digital technologies should food companies leverage as part of a proactive pest management plan?

Harrison: I think this is where the big future is. It’s how do we monitor just in time to provide service based upon that monitor. That’s futuristic looking. For bigger animals, we’re already moving in that direction: A relay goes off when the animal crosses a threshold, and a picture is taken that can be determined by movement and heat. But for the smaller creatures, like rodents and cockroaches, why isn’t there some type of monitoring system as well? From a monitoring and detection standpoint, we’re going to see a lot more technology that helps us very quickly assess what’s going on, which therefore will limit some of the robotic routine services that we do. That’s happening in Europe—it’s not uncommon to have monitors in place and as soon as something happens, you’re out there getting rid of [the pest] rather than putting traditional baits every 25 feet. If you think about it, wouldn’t it be much better that when the mouse is caught in the glue board that immediately a signal goes out and it’s removed rather than sitting there for five days until the pest control professional goes back and checks the device?

The person in charge of pest control wants to come into work and know exactly what’s going on: What pests were seen, what treatments were made, what the local manager is doing, etc. All of it needs to roll up into easy, accessible data. The data collection and reaction would be immediately downloaded every morning or evening when the shift is over. The demand is very clear for what the expectation is.

I’d say within the next year or two you’ll have a variety of companies providing these monitoring systems (inside and outside) to food processing plants.

Syed Hassan of PepsiCo addresses Michael Taylor during FDA Town Hall. Photo: amyBcreative

FDA Investigators Take New Approach with FSMA

By Food Safety Tech Staff
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Syed Hassan of PepsiCo addresses Michael Taylor during FDA Town Hall. Photo: amyBcreative

One of the industry concerns related to FSMA implementation surrounds the change in approach required of FDA investigators—from a resolutions approach to a systematic method of assessing systems and facilities. During an FDA Town Hall at the Food Safety Consortium, Michael Taylor, deputy commissioner for foods and veterinary medicine at the agency explained that he was initially concerned about this shift, but is now pleased with the enthusiasm he sees among FDA investigators. “They’re part of a public health force that is out there empowered and supported in the verifying the systems… as opposed to the historic role of collecting evidence [and] going back to the office…” he said.

Jim Lassiter, president and COO of Ingredient Identity

Will FSMA Push Ingredients into a New Era of Scrutiny?

By Maria Fontanazza
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Jim Lassiter, president and COO of Ingredient Identity

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.

Roberta Wagner, Director, Office of Compliance, for the Center for Food Safety and Applied Nutrition at FDA

How is FDA Surveillance Keeping Pace with FSMA Changes?

By Sangita Viswanathan
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Roberta Wagner, Director, Office of Compliance, for the Center for Food Safety and Applied Nutrition at FDA

Proposed rules under the Food Safety Modernization Act will mandate more inspections, more testing, and better risk-based profiling of food products – both sourced domestically and imported. How is FDA planning to keep pace with these changes? Roberta Wagner, Director, Office of Compliance, for the Center for Food Safety and Applied Nutrition at FDA, provided some insights, while speaking at the recent Food Safety Consortium, organized by Food Safety Tech. 

Section 201 under the Food Safety Modernization Act requires the Food and Drug Administration to designate food facilities at high-risk and non high-risk facilities, and accordingly, establish minimum frequency of inspection of these facilities. While high-risk facilities will have to be inspected by FDA once every three years, facilities deemed non high-risk will be inspected once every five years. Wagner described that the following factors have been considered so far for determining if a domestic food manufacturing facility is determined to be high-risk or otherwise:

  • Whether the facility has been involved in a Class 1 outbreak or recall;
  • Whether the facility has a history of non-compliance (based on Official – Action Indicated (OAI) or Voluntary Action Indicated (VAI) data);
  • If the facility has had any significant violations;
  • Future data considerations (see below);
  • Type of activity the facility is involved in; and
  • Date of last inspection.

Future data for consideration of high-risk and non high-risk categorization will include:

  • Inherent risk factors at product level (for instance is the product bakery goods, or seafood/ fresh produce etc);
  • Has the facility been linked to an outbreak, recall or adverse event (if so the risk profile gets elevated);
  • If any sample testing (product or environmental) is positive;
  • If there’s a history of customer complaints;
  • Robustness of QA/QC programs and 3rd part audit reports;
  • Financial viability of the company; and
  • Food safety culture of the facility/ company.

Foreign facility inspections

Under FSMA, FDA has also been mandated to increase the number of inspections the agency does on foreign facilities, to ensure the safety of imported foods. Wagner explained that FDA currently conducts about 1200 foreign facility inspections a year to determine if those facilities meed FDA regulations. With FSMA rules, FDA will have increased authority to conduct such inspections of foreign faciligies, and look at Foreign Supplier Verification Programs, and Voluntary Qualified Importer Program records, adds Wagner.

Under the new regimen, FDA has been mandated to conduct at least 600 foreign inspections during the first year of FSMA rule implementation. And the target is to double this number every year, for the next five years, taking it to 19,200 inspections by Year 6. Wagner feels this is an impractical number as FDA does not have the resources to do so many foreign inspections. “If we get the Foreign Supplier Verification Program under FSMA rule right, we effectively place the responsibility for ensuring safety of imported foods on the food industry and importers. FDA cannot, and should not be doing this,” she explains.

Risk-based foreign facility site selection

FDA will also adopt a risk-based approach to select foreign facilities for further inspection. This approach will consider:

  • Food safety risk associated with the sector or commodity;
  • Risk associated with manufacturing process;
  • Compliance history of facilities associated with an industry sector commodity in a given country or region (for instance, look at refusal rates for products denied try into the U.S. by country);
  • Quantity or volume of imported product from country or region;
  • Robustness of food safety system in the country; and
  • Portion of resources retained by the facility for compliance, follow up inspections and emergency response situations.

Based on this FDA will continue to diversify the product that it considers high risk, for instance dairy, baby food, candy… Wagner added that economically motivated adulterated continues to be a concern and cause for focus on food products such as oils, honey and dietary supplements.

Wagner also talked about Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting or PREDICT, a risk management tool used by FDA to efficiently and effectively make entry admissibility, decisions that prevent entry of adulterated, mis-branded or otherwise violative imported goods into the U.S., while expediting the entry of non-violative goods. Based on risk scores allocated to different products, this computerized tool targets entries of highest risk for further scrutiny, including field reviews and sampling.

She explained that this dynamic tool, which constantly adapts to different risk situations and products, provides automatic data mining and pattern recognition, provides automated queries of FDA databases including facility registration information, and thus, allows for risk-based allocation of FDA resources.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

FSMA Fridays: Concerns Around High-Risk Food Methodology

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

In February 2014, FDA published a Draft Approach for Designating High-Risk Foods under the Food Safety Modernization Act, with the purpose to identify high-risk foods based on specific parameters for additional recordkeeping requirements to enable rapid, effective tracking in the event of foodborne illness outbreak.

What are the factors by which a food is designated as ‘high-risk?” will FDA do such an analysis for every single food product? And what are concerns about this approach?

At a recent FSMA Fridays webinar, presented by SafetyChain, Dr. David Acheson and Jennifer McEntire, Ph.D., of The Acheson Group focused on this topic.

What will the high-risk foods list be used for?

Dr. David Acheson: What FDA wants to do with the high-risk foods list is to mainly leverage this for better product tracking. FDA will also have greater authority to ask for more information and keep more records for these high-risk foods, though the agency hasn’t clearly specified what information yet. Also the frequency of routine inspections for high-risk foods will be greater: once every three years, compared to once in every five years for non-high risk foods. One area which FDA hasn’t elaborated on is importers needing certificates for high-risk foods entering the U.S. Initially, the agency had considered this, but didn’t have a system in place to require this. Now the requirements are proposed in the FSMA rules and third-party audits can support this.

What are factors that will determine if a food is high risk?

Jennifer McIntyre: FDA considered several areas and has finalized a detailed methodology to identify high-risk foods based on the following parameters:

  • Frequency of outbreak and occurrence of illness associated with that food since 1998;
  • Severity of those illnesses;
  • Likelihood of contamination;
  • Growth potential of that food;
  • Is there an opportunity during processing for that product to become contaminated;
  • Consumption of that food product; and
  • Economic impact associated with that food product in case there’s an outbreak or recall.

This approach is based on an evaluation of chemical and microbial hazards combined with foods using criteria that encompass the FSMA-required factors.

How will each food be scored and is there a distinguishing line between high-risk and non-high risk foods?

McEntire: Food will be rated on a 1 to 9 scale, with 1 being low, 3 being medium, and 9 being high. Companies have these three options to choose from. There’s no clear line the agency has proposed to determine what foods are on the list and what aren’t.

Is FDA going to do this analysis for every single food product? Where will they get the data from?

Acheson: There’s no way the agency can do this for every single food product. They are looking at a lot of parameters to consider. What they might do, and they are already doing, is try to bunch food products and commodities together, so there will be buckets of food identified as high-risk and non high-risk. Getting all that data will prove to be a challenge, considering that what’s available is quite thin. Private sector may have data that could help the agency, but then there’s the concern that if you share the data voluntarily, you have a risk of your product being classified as high-risk.

Are there any concerns being expressed in the industry about this approach?

McEntire: There are many concerns that industry is expressing right now, such as, given the limited data, how do you choose which foods to look at? How do you make sure that the analysis of one food can be applied to another food? How can we factor differences in processing and facilities? How will all the data be used? The parameters specify considering outbreaks going back to 1998 – some of this information has changed tremendously, and this will not factor in new regulations under FSMA.

One major concern is how can I get off the list? If you are considered a high-risk food now, but change your methodologies etc., can you get off the list? We need to see another iteration of this proposed rule from FDA to see if this rule can evolve and address some of these concerns.

What are some next steps for high-risk food methodology and what should industry do to prepare?

Acheson: Determining whether a food is high-risk or low risk will depend on the type of data being collected. The agency’s authority to increase demand for data for purposes of better tracking will require more robust data collection on the part of industry. Food companies will need to assess the data sets they are collecting now, and their product tracking system. Consider the IFT report and its recommendations to learn specifically what data should be collected. If a company determines that some of its products are going to be designated as high-risk, then they need to consider what the criteria will be for gaining that import certificate. Is that food being produced according to the standards that FDA is expecting? Pay attention to your foreign suppliers and ensure that they understand the need to be compliant with FSMA rules, and have sound food safety programs in place.

If this rule is a one-way street, where a food can only be moved from low-risk to being designated as ‘high-risk,’ then that would be disappointing and would detract from seeking improvement and rewarding behavior. The rule needs to consider situations when a company puts in specific mitigation steps in place, so can the food then be categorized as low risk?

For more details and to access FSMA Fridays webinars, please click here.