Tag Archives: inspection

Tim Curran, Sample6
FST Soapbox

Putting FSMA Into Practice

By Tim Curran
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Tim Curran, Sample6

High-profile food recalls and food-borne illnesses continue to keep food safety top of mind. Yet, many in the industry are still struggling to put the best practices we’ve learned over the years about how to properly secure our global food chain into practice. Put simply: The focus needs to be on prevention rather than reaction.

Food safety procedures must be strengthened across the board to meet increasing regulatory pressures and prevent massive recalls and illness outbreaks. FSMA puts the principles of prevention into law. The first major update of federal food safety laws since 1938, it was signed into law by President Obama at the start of 2011. After years of debate, it is now finalized and implementation can begin. The objective of FSMA is to ensure that the U.S. food supply is safe by shifting the focus from reaction to prevention. Now, who can argue with that?

FSMA also pushes the FDA to extend beyond its traditional reactive role. For the first time, the FDA has the power to stop unsafe and possibly contaminated food from entering the food supply.

Let’s take a quick step back so we can explore how to best put it into action. FSMA is made up of five primary provisions:

  • Preventive controls
  • Inspection and compliance
  • Imported food safety
  • Response
  • Enhanced partnerships

I’d argue that the first provision is the true heart of FSMA: Prevention. The first provision focuses on preventative controls and provides a framework for an effective food safety program. In FSMA, this is broken into five key parts, including hazard analysis, preventative controls, monitoring, corrective action and verification. But what does that mean to you? You can best comply with these requirements by implementing better visualization, documentation and communication tools. Let’s walk through each section and the types of tools that you should consider.

Hazard Analysis. Most companies have strong HACCP plans in place, taking account food safety hazards at all stages of production. Risk assessment and risk management must be taken into account and critical control points defined. However, to manage this going forward, consider tools that enable visibility into the current and historical situation at those control points to allow your team to see their proximity to each other, as well as to other components in the plant.

Preventive Controls. Preventative controls are also called out as part of the FSMA requirements. This includes food allergen, supply-chain and sanitation controls in place, as well as sound recall plans. Again, critical control points (CCPs) are the key to ensuring your controls are effective. Also, consider trying indicator test points to stay one step ahead! Indicator test points, as advocated by food safety leader, John Butts, are one or more steps removed from your CCPs. By testing in these areas, you can identify possible risk areas before they even reach control points. This enables a much more proactive approach.

Monitoring. Your plant should have a monitoring plan that includes written procedures for monitoring preventive controls and how frequently they should be performed. This plan should take into account zone coverage, randomization, test frequency, test timing and sampling order. Depending on the business and regulatory rules of a plant, testing should include non-food contact and food contact surfaces. In order to ensure that testing is representative of the conditions in the plant, randomization of test points is important. In addition, test frequency and test timing should be defined, and organizations should seek tools that help to automate these business rules.

Corrective Action. Hope for the best, but always plan for the worst. What is your corrective action plan? You must have a written procedure for identifying and correcting a problem. For both your plant and for regulators, a clear record of your plan and that the steps were followed to close out any issues is required. Make sure that the team understands the steps that are required, number of re-tests and any recall requirements. Look for tools that automatically alert the relevant team members of the situation and track response and testing so that you can easily share this level of detail as needed.

Verification. Trust but verify. Having a plan is only half the job. Using your environmental and finished product testing programs to ensure that controls and corrective actions are effective turns your plan into action. Rapid testing technologies keep the time between testing and results tight. Also, communication of verification results keeps the team coordinated around food safety.

The move to more preventative food safety procedures does not have to create massive headaches. Compliance with FSMA will ultimately help your business and guarantee that you are providing safe food for your customers to consume. Many food companies have been implementing these best-practice guidelines for years. Thanks to FMSA, we all now get an easy-to-follow checklist.

Shifting from reaction to prevention makes food safer—and now, it is also the law. The first step is to make sure you have a good understanding of the components. Only then can you find the best tools and technologies to support you. Lastly, make sure that your team is well aligned around the goals and objectives of your food safety program. Together, we can make food safer.

Huisken Meat, beef patty recall

More Than 89,000 Pounds of Beef Recalled Over Fear of Wood Contamination

By Food Safety Tech Staff
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Huisken Meat, beef patty recall

After uncovering foreign material in an incoming ingredient during the production process, Huisken Meat Company has recalled 89,568 pounds of beef patties. According to the USDA, the recall is due to concern that the products may be contaminated with “extraneous wood materials”. The Sam’s Choice Black Angus Vidalia Onion patties come in 2-lb boxes and were shipped to retailers across the country, including Walmart.

There have been no reports of adverse reactions, and the USDA is advising that consumers throw out the items or return them to the retailer.  

Beyond incidental contamination, are food companies prepared for intentional contamination?

FSMA: Biggest Challenge is Preparation, Outbreaks Still to Come, Says FDA

By Maria Fontanazza
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FDA's Michael Taylor called the journey to FSMA an "amazingly robust process". (Click to enlarge)
FDA’s Michael Taylor called the journey to FSMA an “amazingly robust process”. VIEW VIDEO

FSMA isn’t about zero risk but rather minimizing the hazards, said Michael Taylor, FDA’s deputy commissioner for foods and veterinary medicine at the opening of the Food Safety Consortium conference yesterday. “We have hundreds of thousands of businesses that are subjected to something that they weren’t before,” said Taylor. “The reality is, we’re still going to have outbreaks this year and the next year.”

In his first public speech since three final FSMA rules (on produce safety, foreign supplier verification, and accredited third-party certification) were filed on the Federal Register last week, Taylor shared some of the highs of the formation of the regulation as well as the challenges that are to come with implementation. “Many of us who were involved in the process 20 years ago didn’t imagine we’d get here today,” he said.

Syed Hassan of PepsiCo asks Michael Taylor how FDA will handle the shift in mindset that FSMA requires of agency investigators.
Syed Hassan of PepsiCo asks Michael Taylor how FDA will handle the shift in mindset that FSMA requires of agency investigators. (Click to enlarge)

Right now FDA is looking at the big picture challenge of preparing the agency and industry, and actually getting the work done. Taylor called the implementation challenge “enormous”, thanks to the significant scale of the food system, and said the import piece of the regulation will take the most hands on deck. The ultimate goal of FSMA is real-time prevention versus reaction, and the regulation will require a lot of change within FDA. According to Taylor, the agency is revamping its internal management processes, along with its training and orientation programs, which also includes food safety culture training. Other activities include restructuring the inspection and compliance approach by realigning its field force to have fully specialized teams of inspectors.

One of the challenges that industry sees is the mindset shift in investigators from a resolutions approach to a systematic approach in assessing systems. When asked how FDA will get investigators to this level, Taylor admitted he was a lot more worried about the issue than he is now. The district folks in the front line are enthusiastic about the new approach and feel empowered by FDA’s new mission, he said. And while he didn’t want to be a Pollyanna about the extent of the effort, FDA knows that the agency workforce will not be 100% aligned on day one of implementation and is managing the process with this awareness.

Voluntary compliance is key, and while the weight of ultimate accountability stands on the shoulders of food and beverage companies, success cannot happen without collaboration with FDA. “We are convinced we’ll get 90% of the job done by working with those who are committed to doing the right thing,” said Taylor. “When that fails, there are other ways to deal with that issue.”

Five of the seven FSMA rules have been finalized. Michael Taylor and Rick Biros, publisher of Food Safety Tech and conference director of the Food Safety Consortium take a selfie to capture the "Kodak" moment.
Five of the seven FSMA rules have been finalized. Michael Taylor and Rick Biros, publisher of Food Safety Tech and conference director of the Food Safety Consortium, take a selfie to capture the “Kodak” moment.

All images by amyBcreative photography.

Listeria in Retail a Complex Challenge

By Maria Fontanazza
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The presence of Listeria monocytogenes in retail establishments can become a persistent problem. While maintaining vigilant and strict cleaning practices is key to reducing the risk, Haley Oliver, Ph.D., associate professor of food science at Purdue University cautions there is no silver bullet for a cleaning strategy, because every store is different. The rate of Listeriosis has not decreased but rather has plateaued, and controlling Listeria is a growing problem, forcing it to be a hot topic at this year’s IAFP conference.

“Attempting to regulate an industry as broad as retail in the United States is a huge challenge,” said Kevin Smith, Ph.D., senior advisor for food safety at FDA’s Center for Food Safety and Applied Nutrition. According to Smith, more than 2200 agencies are responsible for the licensing and inspection of retail facilities. Due to the massive size of the industry, much of the actions surrounding driving compliance and enforcing regulations occur through state, local, and tribal authorities.

The Food Safety and Inspection Service (FSIS) attributed 83% of Listeriosis cases to deli meats that were sliced at a retail counter, (as opposed to meats prepackaged at a facility). Retailers should be using the FSIS guidelines released in June,  “Best Practices Guidance for Controlling Listeria monocytogenes in Retail Delicatessens“, for specific information about how they can ensure the safety of products such as deli meats. Revisions to the guidance include a clarification that food processing equipment should be taken apart during cleaning and sanitizing; an added recommendation that retailers scrub surfaces during cleaning to prevent biofilm formation; and clarification that retailers rotate sanitizers to avoid development of resistance. According to Kristina Barlow of FSIS, these practices can extend beyond deli meats to any products that are prepared at retail.

Learn more about Preventing Listeria Contamination: A Practical Guide to Food Safety Controls

Date: Wednesday, August 5

Time: 2 pm – 3 pm ET

Barlow outlined areas that the Listeria best practices guidelines address, including:

  •  Product handling. “Use products formulated with antimicrobial agents to prevent growth of Lm—96% illnesses could be reduced if retailers used these products,” said Barlow.
  • Cleaning and sanitizing. It is recommended that retailers develop written sanitation procedures outlining the daily frequency in which utensils and equipment should be cleaned and sanitized. Equipment should be cleaned every four hours, and surfaces scrubbed to prevent biofilm formation. Barlow advised that retailers document all actions they perform to ensure that procedures are carried out each day.
  • Facility and equipment controls. Ensure that the floors, walls and overhead structures are clean. Listeria that is harbored in drains is more likely to creep its way into equipment, and the bacteria can also hide under dust and floors, so it is important to avoid construction when food products are exposed.
  • Employee practices. Use gloves, train in sanitation practices, and make sure that information is available to employees in multiple ways (i.e., other languages and use of images). In addition, implement policies to ensure that ill employees are not working with food; and limit employee traffic in the deli area—develop traffic flow plans for product, employees and other items to prevent contamination by both consumers and employees. Finally, employees should change aprons or other frocks when soiled. “Gone are the days when the butcher is covered in blood [and] serving people,” said Barlow.
Melanie J Neumann is Vice President and Chief Financial Officer for The Acheson Group
Beltway Beat

FSMA: Get Inspection-Ready with These Best Practices

By Melanie J. Neumann
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Melanie J Neumann is Vice President and Chief Financial Officer for The Acheson Group

Although FDA immediately gained increased authority for records access upon the signing of FSMA in January 2011, some companies haven’t gotten the memo yet.  

The following best practices will help food and beverage manufacturing facilities get inspection ready and offer guidance on how to push back if overreaching occurs.

  • Keep a paper trail. Documentation and recordkeeping is crucial. Disclosure is relevant only to the documents that FDA is allowed to have, such as production documentation. This does not apply to proprietary/trade secret information (i.e., financials and recipes).
  • Appoint a designated person to guide FDA during the inspection. This person should be the sole contact for all requests of documents, information, samples, etc., and accommodate requests for information from the inspector, as long as they are reasonable and in scope. This point person must have adequate training and experience in regulatory requirements and recent changes to have an awareness of what records inspectors are and are not technically authorized to review or access. If you are unsure of what the inspector is asking for at any point, we have a word of advice: Never speculate; always ask for clarification.
  • Duplicate everything. If the inspector takes swabs or photos, shadow him/her and take duplicate swabs and/or photos so you have a record of what was taken by the agency. It’s another question whether to take the swabs to test or not—but at least have a replica of what the agency has so you have the same or very similar information.
  • Engage legal if you feel that lines are being crossed. When you think inspectors have crossed the line into records to which they should not have access, it’s okay to respectfully state that you would like to speak with your legal counsel prior to disclosing the record. Make it clear you are not outright refusing to produce the document; rather that you are unsure what the company policy and/or regulation is on disclosure of that particular document/piece of information; and, as such, you wish to seek legal counsel prior to disclosing.
  • If you do refuse outright to produce requested information, do so wisely. Inspectors are given clear guidance on what actions to take if met with refusals.  Criminal provisions of the Act may be invoked but this is in the most egregious of cases. Some of the guidance relevant to inspectors that food companies should be aware of are stated in the FDA Inspector Inspection Manual and are included below to give you an idea of the response you may receive to an outright inspection refusal or refusal to allow copying of records:
    • 2.6 – INSPECTION WARRANT. A refusal to permit inspection or a refusal to permit access to or copying of records may invoke criminal provisions of sections 301(e) and 301(f) of the FD&C Act [21 U.S.C. 331(e), (f)].
    • However, as stated in 5.2.5, the request still needs to be fair and reasonable:
    • 2.5 – INSPECTION REFUSAL. Refusal as used in your IOM means refusing to permit an inspection or prohibiting you from obtaining information to which FDA is entitled under the law. In the case of a refusal you must show your conduct was reasonable, fair, and you exercised reasonable precaution to avoid refusal. You must have shown your credentials and given the responsible individual a properly prepared and signed Notice of Inspection, FDA 482.
    • 2.5.2 – Refusal to Permit Access to or Copying of Records. If management objects to the manner of the inspection or coverage of specific areas or processes, do not argue the matter but proceed with the inspection. However, if management refuses to permit access to or copying of any record to which you are entitled under law, call attention to Section 301(e) of the FD&C Act[21 U.S.C. 331] or applicable sections of the PHS Act. If management still refuses, proceed with the inspection until finished.
  • Mark documents confidential/proprietary. Mark all documents and materials disclosed to the inspector as Confidential/Proprietary or Company Confidential Information if you wish to even attempt to maintain confidentiality and keep the information from being disclosed in a Freedom of Information Act (FOIA) release. If not marked as such,  483 information is generally discoverable through FOIA requests.
  • Request your own FOIA. After the inspection, the FDA inspector will write a report called the Establishment Inspection Report (EIR). Best practice is for the company to submit a FOIA request for both a redacted (confidential information removed) and an unredacted copy of the EIR to ensure the information in the report matches the one that the inspector provided to the company. This is requested through the FDA Freedom of Information Office in Rockville, Maryland.
  • If you don’t agree with a 483 item, it can be disputed/appealed. This is done in the standard 483 response in which a firm provides information on corrective actions it will take on issues that do need correcting. As stated in the FDA Field Directive No. 120, “The firm may request clarification, criticize FDA 483 items, disagree with the FDA 483, or raise other questions or issues. In these cases, the District will evaluate the firm’s information and send the District’s conclusion to the firm. A copy shall also be sent to the official establishment file.”

For more details on the topic, see Neumann’s blog, “How Do you Graciously Push Back in an FDA Inspection?”