Tag Archives: FSMA

Learn More about BRC & FSMA Readiness

This video on BRC’s FSMA readiness module is designed to help companies understand how well their facilities are prepared for FSMA. Featuring John Kukoly, Director of BRC’s Americas, the video delivers information on what the program is, how it should be prepared for, expectations for audit time, and how to get started.

Scott Gottlieb, M.D., FDA

FDA Commissioner Announces Steps To Support Produce Safety Rule

By Food Safety Tech Staff
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Scott Gottlieb, M.D., FDA

FDA Commissioner Scott Gottlieb, M.D., announced the next steps in their approach to implement the Produce Safety Rule that was established by FSMA. During the September 12th speech at the National Association of State Departments of Agriculture, Dr. Gottlieb outlined new measures the FDA will be taking, including compliance dates for agricultural water standards, recognized water-testing methods, and inspections related to non-water requirements of the produce rule.

According to the press release, Dr. Gottlieb also announced steps the FDA will take to “address concerns related to the complexity and feasibility of implementing standards for agricultural water.” One proposed rule concerning agricultural water compliance dates, if finalized, would extend compliance dates by up to four years for produce other than sprouts.

The press release states the reasoning behind this change is allowing the FDA to revisit those standards, ensuring they are implementable for farmers across the country. Sprouts are an exception here because of their high risk for contamination and will remain subject to original compliance dates.

The announcement also covered key changes to produce farm inspections, water testing methods and training opportunities for producers and regulators. For more information, see the press release here and the full text of Dr. Gottlieb’s speech here.

Chelle Hartzer, Orkin
Bug Bytes

How to Prepare for an Audit at Any Time

By Chelle Hartzer
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Chelle Hartzer, Orkin

Everybody knows to prepare for the worst while hoping for the best. But being prepared for an unannounced audit isn’t something that can be done overnight, especially when it comes to pest management.

That’s why it’s important to carefully review your food safety plan and the specific pest management measures contained within it. Pest management can account for up to 20% of an audit, so it can make or break a facility’s score. There’s no room to gamble—between federal regulations, audit regulations, internal standards and customer expectations, you need to stay in compliance.

With FSMA in full effect, it’s important to become familiar with the regulations found on the FDA’s website if you haven’t yet. Reacting to problems isn’t good enough anymore, as many of these regulations emphasize a preventive strategy. The FDA has the authority to mandate recalls, shut down facilities and more. If you need help determining the rest of your facility’s food safety program, the FDA has a helpful downloadable food safety plan builder.

To make sure pest issues don’t spoil your score during an unannounced audit, remember that pest management is an ongoing partnership that requires your entire staff’s participation. It’s something you should plan for as part of regular maintenance and sanitation schedules.

The first step is to establish an integrated pest management (IPM) program. This plan should be developed with your pest management provider and should be a comprehensive look at all factors that may contribute to pest issues. It should be designed to reduce pest pressure around a facility, address all sanitation and exclusion issues, actively monitor for pests and set action levels.

The goal is to proactively deal with pests and prevent as many issues as possible. An IPM program is tailored to meet a facility’s specific needs based on a wide range of different factors. An IPM program uses pesticide treatments as a final step once all conducive conditions have been identified and addressed. The program should adapt as both the facility and the pest pressures change over time.

Implement regular training for all employees and encourage participation. Something as simple as a poster featuring the “most wanted pests” in break rooms or locker rooms can help train personnel to recognize the signs of potential pests around the facility. Make it clear that each employee is a key player in your program and empower them to speak up should they see something. Ensure you have a pest-sighting log and all personnel are aware of where it is and how to report issues. Their help will be vital to point out issues, ensure sanitation is adequate and identify problem areas on a daily basis. Your pest control professional can host a training meeting for you and your staff if needed.

When implementing an IPM program at your facility, there are numerous preventive tactics you can implement and perform on a regular basis.

  • Monitoring devices: Using devices like fly lights, rodent traps and bait stations can help reduce pest populations and keep them away from food products. These monitoring devices also offer insight as to how many and what kinds of pests are plaguing the facility, which is valuable information when determining a strategy to resolve existing pest problems and minimize pest pressure.
  • Sanitation: Any food source, including the foods you are producing and storing, can draw pests. Clean up product spills quickly. Don’t forget about food in employee areas such as break rooms and locker rooms. While it is impossible to clean up every food particle (you are producing food at your site!), you can work to limit the access pests have to food sources.
  • Take out the trash: Emptying trash daily and cleaning out the trash bins helps prevent the buildup of organic material, which can attract many different pests. Make sure dumpsters are placed away from the building if possible and always keep them closed. Don’t a smelly garbage or a full bin—when in doubt, take it out!
  • Seal cracks and crevices: Keep a constant watch around the facility for any openings big enough for a pest to fit through. Remind employees that rats only need a quarter-size hole to squeeze into a facility, while mice only need an opening the size of a dime. And that’s not the worst of it; cockroaches only need one sixteenth of an inch, making it vital to seal off any openings found. Don’t forget to look at your facility from the outside as well!
  • Install automatic doors: Often, open doorways are prime locations for pests to enter. All doors should remain closed when not in use. Especially in docking areas when loading/unloading, try to open dock doors only when needed and keep the gap from the truck to doorway sealed off if possible. Installing automatic doors can reduce the likelihood flying pests inside the facility by ensuring doors stay closed when not in use.
  • Inspect shipments: Anytime a new shipment arrives, it should be inspected closely for pests. Stored product pests could be in products and spread to others in close proximity quickly, so catching them early is key. Don’t forget to inspect shipping containers for outgoing product too, because if your product goes in an infested truck, your product will be considered infested!
  • Remove clutter: Many pests love to hide under clutter. Remove unused equipment, product and packaging—especially cardboard boxes—to avoid giving pests a convenient hiding place. Don’t forget about clutter outdoors, too.
  • Outdoor concerns: Sanitation is important outside the facility as well. Make sure to remove clutter and garbage on the ground and near the facility to help reduce pest pressure. Many pest issues start outside, so removing clutter outdoors means fewer pests to potentially get into your site. In addition, installing sodium vapor lights instead of mercury vapor lights near the building will attract fewer insects.
  • Install air curtains: The perfect complement to automatic doors, air curtains create positive airflow—or air flowing outwards from building entrances—to push pests away from the building.

Auditors are looking for a number of things when it comes to pest management. One important item they want to see is the record of past pest issues and the steps taken to resolve them. You and your pest management provider should ensure all records are up to date and accurate with pest trends that can be explained.

Documentation is perhaps the most critical part of a strong IPM program. It ensures your efforts are captured, organized and available should an unexpected auditor arrive on site.

The following are six main documents to have ready at all times.

  1. Food Safety Plan
    Perhaps the most important piece of documentation, the overarching food safety plan is absolutely necessary to have on hand. The plan should be a comprehensive document describing all activities to ensure the safety of food during manufacturing, processing, packing and holding. It should include a list of potential hazards, preventive controls and corrective actions to mitigate those risks, along with monitoring and verification procedures.
  2. List of Service Changes
    An IPM program needs to be dynamic. But when modifications are made to meet the ever-changing needs of a facility, make sure to keep careful records of how and why the plans have changed.
  3. List of Monitoring Devices/Traps
    Your plan must include a map documenting all monitoring equipment, traps and any other devices used around the facility to reduce pest pressure. Note the locations and activity levels of each. The trend report from the collected data can show important information and help make management decisions. Your pest management professionals can help with this, as they should be noting activity each time they inspect your property. Auditors will want to see the historical data of pest monitoring devices and the corrective actions associated with any issues. Monitoring devices work as a great early warning system for developing pest issues and are a great proactive approach.
  4. Annual Assessments
    Each year, you should review your food safety plan and current IPM program. These annual assessments will note problem areas and set goals for the coming year. Auditors will be looking for these yearly assessments, and if you’re able to demonstrate year-over-year improvement then you’ll give your facility a better chance at a great audit score.
  5. Sighting Reports
    If a pest is spotted within the facility, employees should document it on the pest-sighting log. The report should include information about the location of the pest within the facility, who found it and the number of pests spotted. Capturing the pest is ideal, but it’s not always feasible to do so. In that case, photo evidence helps with identification, so obtain a close-up picture of the pest(s) if possible. Ensure the pest is identified and any corrective actions documented.
  6. Proof of Training/Certification
    You know that your pest management professional is trained and certified, but an auditor doesn’t. To demonstrate your provider’s expertise, keep a valid license or certification document, written evidence of the pest management professional’s training, and documentation of internal training on IPM and Good Manufacturing Practices (GMPs).

According to FSMA guidelines, a strong food safety plan identifies potential hazards to food products, and focuses on a preventive, risk-based strategy instead of a reactionary one. With an IPM program in place and detailed documentation of actions taken, you’ll be prepared anytime an auditor decides to “pop in” for a “quick chat.”

Compliance

FDA Releases Small Entity Compliance Guide for Produce Safety Rule

By Food Safety Tech Staff
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Compliance

Learn more about FSMA implementation strategy at the 2017 Food Safety Consortium | November 28–December 1FDA has released a Small Entity Compliance Guide (SECG) to help small and very small businesses comply with the Produce Safety Rule. The SECG provides assistance for farmers in determining whether they are eligible for a qualified exemption and can help them understand the modified requirements as a result.

The compliance dates under the Produce Safety rule are as follows:

  • Small businesses: January 28, 2019
  • Very small businesses: January 27, 2020
  • Sprout operations: January 26, 2018 (small businesses) and January 28, 2019 (very small businesses)
  • There are also extended compliance dates for certain agricultural water requirements
FSMA

FDA Releases Chapter 6 of Draft Guidance for PC Rule

By Food Safety Tech Staff
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FSMA

Last week FDA released the sixth chapter of the draft guidance, “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food”. The document aims to assist food facilities in establishing and implementing a heat treatment (i.e., baking or cooking) to prevent bacterial contamination.

Learn more about FSMA compliance at the 2017 Food Safety Consortium | November 28– December 1 | The 60-page draft guidance addresses the use of heat treatments as a process control, providing information on understanding potential hazards, design and validation of the heat treatment, establishing and implementing monitoring procedures (and how often), verification, and record keeping.

FDA states that it intends to publish at least 14 chapters of the guidance. In just two weeks, the compliance date for the preventive controls for human food rule falls for small businesses (fewer than 500 full-time employees).

FSMA

How the Sanitary Transportation Rule Waiver Applies to Retail Food Establishments

By Food Safety Tech Staff
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FSMA

This week the FDA issued another guidance document to explain a waiver to the Sanitary Transportation rule and that it applies to retail food establishments that sell food for humans as well as those that sell both human and animal food. It does not apply to establishments that exclusively sell animal food.

“The Sanitary Transportation rule established a process by which FDA may waive any of the rule’s requirements for certain classes of persons, vehicles, or types of food if doing so will not result in the transportation of food under conditions that would be unsafe for human or animal health, or contrary to the public interest.” – FDA

In April, FDA announced three waivers that apply to businesses with transportation operations subject to State-Federal controls. Since this time, FDA stated that it has received questions regarding whether the term “retail food establishment” also applies to businesses that sell animal food. “The purpose of the guidance document is to clarify that the waiver is intended to apply to establishments that are covered by human food regulations based on the FDA Food Code and administered by state and local authorities,” FDA stated in a news release.

Earlier this month FDA released three guidances related to low-acid canned foods, juice HACCP and seafood HACCP.

FSMA

FSMA Exempt? FDA Guidances Explain

By Food Safety Tech Staff
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FSMA

This week FDA released three guidances to help food producers understand how the FSMA rules apply to their commodities. The regulations covered in the guidances pertain to low-acid canned foods (LACF), juice HACCP and seafood HACCP. Since FDA’s regulations for HACCP and LACF were in place before the FSMA final rules were established, the agency is clarifying the FSMA requirements as well as exemptions for these products.

The following guidances are available on FDA’s website:

FSMA

Company Resources Critical to FSMA Implementation

By Maria Fontanazza
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FSMA

In Part II of Food Safety Tech’s Q&A with Kathy Wybourn, Director Food & Beverage, USA & Canada at DNV-GL, we discuss FSMA preparedness and alignments of the regulation with GFSI.

Food Safety Tech: Now that we’re in the compliance phase, how prepared are food companies to meet FSMA requirements?

Read Part I: Embracing Big Data as an Asset to Your CompanyKathy Wybourn: It depends. Food companies must want to stay informed and make the necessary changes. What is critical in this change is the resources and organization, and not the size of a company. We still see large companies that are not ready for FSMA, same as with smaller companies. It comes down to what they have done proactively to keep up with the regulations, understanding the preventive pieces of that and the shift within their organization.

There are two pieces: It’s about being informed, plus the company’s culture for change. It comes down to management commitment. If you don’t have the management commitment to move an organization to being compliant with FSMA, you can be informed, but the culture isn’t there to support it.

FST: GFSI recently released Version 7.1 to incorporate more harmonization with FSMA. Any thoughts on this new version?

Wybourn: I was in the Technical Work Group for Version 7 guidance document. Adding in the food fraud and food defense components, and the new 7.1 Version brings the GFSI benchmark document closer to FSMA around suppliers and the use of non-approved suppliers.

It puts more requirements on the food manufacturer if they have supplier problems. For example, if there’s an interruption in the supply of a critical ingredient and you don’t have another supplier that’s going through the preventive hazard. It’s very important to know how to follow the requirements around non-approved suppliers. It all fits with the bigger picture of supply chain risks and transferring risks from a supplier (those things you don’t know about), understanding your suppliers and having a contingency plan. And if you don’t have that formal approval through your system, what are the requirements around using a non-approved supplier.

FST: How can the BRC FSMA Readiness Module help food companies with the Preventive Controls rule?

Wybourn: If you’re a BRC-certified site, it gives you guidance on what is needed to be FSMA ready. BRC benchmarked and identified what was missing in the standard and created a module that minimizes the gap. It gives you guidance and reference to the actual CFR and explains what’s needed.

Judy Black, Rentokil
Bug Bytes

How the Internet of Things Helps Pest Management in Food Processing

By Judy Black
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Judy Black, Rentokil

As the applications of connected devices continues to drive innovation and create exciting possibilities throughout the food processing industry, the impact of the Internet of Things (IoT) on pest management in the food supply chain is already easy to recognize. An ecosystem of connected devices streamlines several processes that are integral to an effective integrated pest management plan, providing convenience and saving time for both food manufacturers and their pest management partners. From creating a smart network of devices that detect changes and track movement in the pest population to seamless reporting procedures that cut down on paperwork, we’re already seeing the benefits of a more connected world on a very important aspect of food safety.

Judy Black will host a free webinar, along with her colleague Jeff Robbins, director of commercial pest marketing, on the applications of IoT in pest management throughout the food supply chain on Wednesday, Aug. 9 at 1:00 pm ET/10:00 am PT. Register hereAt the ground level—often quite literally—we have networked traps for pests ranging from stored product insects to rodents. Each trap tracks the pests it captures and reports its readings to a central hub in real time, providing an instant snapshot of changes in the pest population and triggering notifications when that population exceeds pre-set parameters—well before the pests create an issue. Beyond knowing when a pest population increases in a facility, this network of connected monitoring devices can pinpoint where those pests are congregating, allowing the facility’s pest management partner to identify and eliminate the source of the issue quickly.

Beyond those devices on the front lines, the IoT also has a major impact on the behind-the-scenes management of pest management processes. With the increase in reporting requirements brought on by the adoption of FSMA earlier in the decade came a lot of new paperwork for food manufacturers. On the pest management front, the paper trail required to track the steps taken to reduce the risk of pest infestation represents a significant commitment of time and effort on the part of facility managers. Working with a pest management partner that understands the opportunities connected devices provide means less paperwork; a centralized online hub allows facility managers to review their partner’s recommendations, indicate the steps they’ve taken to address issues and close the loop without having to touch a file cabinet.

The availability of this pest-tracking data allows forward-thinking pest management companies to be more efficient and better informed. By compiling and analyzing this data, they can identify regional trends in pest populations, allowing them to be better prepared to recognize and resolve pest issues early and to stay ahead of cyclical fluctuations in the pest population.

We often talk about technology in terms of the impact it will have in the future, but in the pest management business, we’re already seeing the benefits of a connected ecosystem of devices. While the technology will continue to evolve and improve, it’s important for food manufacturers to recognize the benefits of working with a pest management partner that embraces the IoT. By streamlining and centralizing the processes of monitoring and reporting on pest management practices, this technology saves time and reduces the risks pests pose throughout the food supply chain.

USP Food Fraud Database

Why Include Food Fraud Records in Your Hazard Analysis?

By Karen Everstine
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USP Food Fraud Database

Food fraud is a recognized threat to the quality of food ingredients and finished food products. There are also instances where food fraud presents a safety risk to consumers, such as when perpetrators add hazardous substances to foods (e.g., melamine in milk, industrial dyes in spices, known allergens, etc.).

FSMA’s Preventive Controls Rules require food manufacturers to identify and evaluate all “known or reasonably foreseeable hazards” related to foods produced at their facilities to determine if any hazards require a preventive control. The rules apply both to adulterants that are unintentionally occurring and those that may be intentionally added for economically motivated or fraudulent purposes. The FDA HARPC Draft Guidance for Industry includes, in Appendix 1, tables of “Potential Hazards for Foods and Processes.” As noted during the recent GMA Science Forum, FDA investigators conducting Preventive Controls inspections are using Appendix 1 “extensively.”

The tables in Appendix 1 include 17 food categories and are presented in three series:

  • Information that you should consider for potential food-related biological hazards
  • Information that you should consider for potential food-related chemical hazards
  • Information that you should consider for potential process-related hazards

According to the FDA draft guidance, chemical hazards can include undeclared allergens, drug residues, heavy metals, industrial chemicals, mycotoxins/natural toxins, pesticides, unapproved colors and additives, and radiological hazards.

USP develops tools and resources that help ensure the quality and authenticity of food ingredients and, by extension, manufactured food products. More importantly, however, these same resources can help ensure the safety of food products by reducing the risk of fraudulent adulteration with hazardous substances.

Incidents for dairy ingredients, food fraud
Geographic Distribution of Incidents for Dairy Ingredients. Graphic courtesy of USP.

Data from food fraud records from sources such as USP’s Food Fraud Database (USP FFD) contain important information related to potential chemical hazards and should be incorporated into manufacturers’ hazard analyses. USP FFD currently has data directly related to the identification of six of the chemical hazards identified by FDA: Undeclared allergens, drug residues, heavy metals, industrial chemicals, pesticides, and unapproved colors and additives. The following are some examples of information found in food fraud records for these chemical hazards.

Undeclared allergens: In addition to the widely publicized incident of peanuts in cumin, peanut products can be fraudulently added to a variety of food ingredients, including ground hazelnuts, olive oils, ground almonds, and milk powder. There have also been reports of the presence of cow’s milk protein in coconut-based beverages.

Drug residues: Seafood and honey have repeatedly been fraudulently adulterated with antibiotics that are not permitted for use in foods. Recently, beef pet food adulterated with pentobarbital was recalled in the United States.

Heavy metals: Lead, often in the form of lead chromate or lead oxide which add color to spices, is a persistent problem in the industry, particularly with turmeric.

Industrial Chemicals: Industrial dyes have been associated with a variety of food products, including palm oil, chili powder, curry sauce, and soft drinks. Melamine was added to both milk and wheat gluten to fraudulently increase the apparent protein content and industrial grade soybean oil sold as food-grade oil caused the deaths of thousands of turkeys.

Pesticides: Fraud in organic labeling has been in the news recently. Also concerning is the detection of illegal pesticides in foods such as oregano due to fraudulent substitution with myrtle or olive leaves.

Unapproved colors/additives: Examples include undeclared sulfites in unrefined cane sugar and ginger, food dyes in wine, and tartrazine (Yellow No. 5) in tea powder.

Adulteration, chili powder, skim milk powder, olive oil
Time Series Plot of Records for Chili Powder (blue), Skim Milk Powder (green), and Olive Oil (orange)

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