Tag Archives: FSIS

Manuel Orozco, AIB International
FST Soapbox

Detecting Foreign Material Will Protect Your Customers and Brand

By Manuel Orozco
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Manuel Orozco, AIB International

During the production process, physical hazards can contaminate food products, making them unfit for human consumption. According to the USDA’s Food Safety and Inspection Service (FSIS), the leading cause of food recalls is foreign material contamination. This includes 20 of the top 50, and three of the top five, largest food recalls issued in 2019.

As methods for detecting foreign materials in food have improved over time, you might think that associated recalls should be declining. To the contrary, USDA FSIS and FDA recalls due to foreign material seem to be increasing. During the entire calendar year of 2018, 28 of the 382 food recalls (7.3%) in the USDA’s recall case archive were for foreign material contamination. Through 2019, this figure increased to approximately 50 of the 337 food recalls (14.8%). Each of these recalls may have had a significant negative impact on those brands and their customers, which makes foreign material detection a crucial component of any food safety system.

The FDA notes, “hard or sharp foreign materials found in food may cause traumatic injury, including laceration and perforation of tissues of the mouth, tongue, throat, stomach and intestine, as well as damage to the teeth and gums”. Metal, plastic and glass are by far the most common types of foreign materials. There are many ways foreign materials can be introduced into a product, including raw materials, employee error, maintenance and cleaning procedures, and equipment malfunction or breakage during the manufacturing and packaging processes.

The increasing use of automation and machinery to perform tasks that were once done by hand are likely driving increases in foreign matter contamination. In addition, improved manufacturer capabilities to detect particles in food could be triggering these recalls, as most of the recalls have been voluntary by the manufacturer.

To prevent foreign material recalls, it is key to first prevent foreign materials in food production facilities. A proper food safety/ HACCP plan should be introduced to prevent these contaminants from ending up in the finished food product through prevention, detection and investigation.
Food manufacturers also have a variety of options when it comes to the detection of foreign objects from entering food on production lines. In addition to metal detectors, x-ray systems, optical sorting and camera-based systems, novel methods such as infrared multi-wavelength imaging and nuclear magnetic resonance are in development to resolve the problem of detection of similar foreign materials in a complex background. Such systems are commonly identified as CCPs (Critical Control Points)/preventive controls within our food safety plans.

But what factors should you focus on when deciding between different inspection systems? Product type, flow characteristics, particle size, density and blended components are important factors in foreign material detection. Typically, food manufacturers use metal and/or x-ray inspection for foreign material detection in food production as their CCP/preventive control. While both technologies are commonly used, there are reasons why x-ray inspection is becoming more popular. Foreign objects can vary in size and material, so a detection method like an x-ray that is based on density often provides the best performance.

Regardless of which detection system you choose, keep in mind that FSMA gives FDA the power to scientifically evaluate food safety programs and preventive controls implemented in a food production facility, so validation and verification are crucial elements of any detection system.

It is also important to remember that a key element of any validation system is the equipment validation process. This process ensures that your equipment operates properly and is appropriate for its intended use. This process consists of three steps: Installation qualification, operational qualification and performance qualification.

Installation qualification is the first step of the equipment validation process, designed to ensure that the instrument is properly installed, in a suitable environment free from interference. This process takes into consideration the necessary electrical requirements such as voltage and frequency ratings, as well as other factors related with the environment, such as temperature and humidity. These requirements are generally established by the manufacturer and can be found within the installation manual.

The second step is operational qualification. This ensures that the equipment will operate according to its technical specification. In order to achieve this, the general functions of the equipment must be tested within the specified range limits. Therefore, this step focuses on the overall functionality of the instrument.

The third and last step is the performance qualification, which is focused on providing documented evidence through specific tests that the instrument will performs according to the routine specifications. These requirements could be established by internal and industry standards.

Following these three steps will allow you to provide documented evidence that the equipment will perform adequately within the work environment and for the intended process. After completion of the equipment validation process, monitoring and verification procedures must be established to guarantee the correct operation of the instrument, as well procedures to address deviations and recordkeeping. This will help you effectively control the hazards identified within our operation.

There can be massive consequences if products contaminated with foreign material are purchased and consumed by the public. That’s why the development and implementation of a strong food safety/ HACCP plan, coupled with the selection and validation of your detection equipment, are so important. These steps are each key elements in protecting your customers and your brand.

FST Soapbox

FDA Announces Inspections Will Resume…Sort Of

By Trish Wester
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FDA Commissioner Stephen Hahn, M.D. recently announced that food safety inspections will resume in July, but inspectors will be given leeway to accommodate the coronavirus pandemic. Inspections will be prearranged by appointments. The agency suspended routine inspections in late March as a result of the pandemic response, which closed down much of the country.

USDA/FSIS has continued to provide inspection services for eggs, meat and poultry throughout the COVID-19 outbreak, with a significant number of establishments involved in outbreak clusters and periodic shutdowns.

The “White House Guidelines for Opening Up America Again” calls for the FDA to send out investigators for on-site inspections by the week of July 20, using the COVID-19 Advisory Rating system, which utilizes state and national data about infection rates to determine the regions where enforcement can resume.

In a July 10 FDA statement Hahn noted, “resuming prioritized domestic inspections will depend on the data about the virus’ trajectory in a given state and locality, and the rules and guidelines that are put in place by state and local governments.”

One of the most significant modifications for domestic inspections in the announcement is that they will be pre-announced to FDA-regulated businesses. “This will help assure the safety of the investigator and the firm’s employees, providing the safest possible environment to accomplish our regulatory activities, while also ensuring the appropriate staff is on-site to assist FDA staff with inspection activities,” Hahn said. Previously, most inspections were unannounced.

It’s not entirely clear how FDA will use the White House guidelines to determine where they can schedule inspections. There is mention of a prioritization mechanism that will identify high-risk operations, but that has traditionally been part of FDA’s approach to inspections.

The CDC published phased guidelines for states to follow in reopening, which are referred to in the announcement. The guidelines document outlines the gating criteria for states, but published versions do not mention inspection requirements. Many states began reopening without meeting all of the gateway criteria for Phase 1, and continued to accelerate reopening activities in a way that makes it unclear which phase criteria they may have actually met when compared to the phase under which they claim to be operating.

Further complicating the safety issue is the recent rising number of COVID-19 cases that is causing some states to pause or rollback reopening activities. Since publishing the announcement, several states have emerged as new COVID-19 hot spots, including Texas, Arizona and Florida; In addition, Florida has surpassed New York in total cases. California, another food producing state heavily affected by the pandemic, is seeing a significant increase in cases and is considering issuing new shelter-in-place orders. It was recently reported that CDC has identified 21 states as “Red Zones”, with at least 11 states on the verge of surging cases.

In other words, with the virus on the rise, there may not be a significant number of inspections actually performed, regardless of whether or not inspections have technically resumed, simply because there just isn’t a safe way to send inspectors out.

The FDA has also published the “New Era of Smarter Food Safety Blueprint”, which includes ways the agency could use technology to support compliance activities. There may be an opportunity for the FDA to implement new tools such as remote verification in lieu of onsite inspections, but that remains to be seen. Among such tools, remote audit pilots were recently completed and those results will be available for public presentation at the end of August.

In the short term, should FDA determine you are an inspection candidate, you will contacted in advance to schedule a day and time.

Marketside Ground Beef

Nearly 43,000 Pounds of Ground Beef Recalled Due to Potential E. Coli Contamination

By Food Safety Tech Staff
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Marketside Ground Beef

Swedesboro, NJ-based Lakeside Refrigerated Services recalled about 42,922 pounds of ground beef products over concern of potential E. coli O157:H7 contamination. The Class I recall involves raw ground beef products that were produced on June 1.

The issue was uncovered during routine FSIS testing. The products were reportedly distributed to retailers, including Walmart, nationwide. Thus far there are no reports of adverse reactions due to consumption of the affect products.

A full list of the recalled products are available on the USDA’s website.

Coronavirus, COVID-19

Fourth USDA Food Safety Inspector, at Least 30 Meat Plant Workers Dead from COVID-19

By Food Safety Tech Staff
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Coronavirus, COVID-19

Last week another USDA food safety inspector died as a result of COVID-19. Time reported the unidentified inspector was located in Dodge City, Kansas, and cited a brief USDA statement: “USDA can confirm the passing of an employee. The safety and well being of our employees is our top priority. We thank those working on the front lines of our food supply chain for remaining on the job and for making sure the American people have access to safe food.”

Attend the webinar, “Is Your Plant COVID-19 Safe?” | May 27,2020 at 12 pm ET According to the report, at least 30 workers at meat plants have died of coronavirus, and a fourth USDA inspector as of May 14. More 100 USDA FSIS employees were self-quarantining as a result of exposure to COVID-19 and 171 field employees were diagnosed with the virus and did not report to work.

Worker safety at meat plants has been a concern for months, and the industry has been grappling with the threat of a meat shortage. On April 28, President Trump signed an executive order to keep meat and poultry processing facilities open during the COVID-19 crisis.

Paul Kiecker, FSIS, USDA

Paul Kiecker Takes Reins as FSIS Administrator

By Food Safety Tech Staff
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Paul Kiecker, FSIS, USDA

In an announcement from U.S. Secretary of Agriculture Sonny Perdue, Paul Kiecker has been named the administrator of USDA’s Food Safety and Inspection Service. The move comes with the departure of Carmen Rottenberg, who served in the role as administrator for almost two years, and is leaving federal service altogether.

“As Administrator, Rottenberg spearheaded efforts to modernize the agency and implemented several key initiatives to target foodborne illness. Through her leadership and oversight, an unprecedented level of collaboration was achieved with federal, state and municipal agencies and other stakeholders,” according to a USDA press release.

Paul Kiecker began serving as deputy administrator for FSIS in May 2018 and was the USDA’s acting administrator until January 2019. He has been at FSIS for 30 years, beginning his career at the agency as a food inspector.

Recall

Simmons Prepared Foods Recalls More than 2 Million Pounds of Poultry Products

By Food Safety Tech Staff
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Recall

Yesterday Arkansas-based Simmons Prepared Foods, Inc. initiated a Class I recall of 2,071,397 pounds of poultry products over concern of foreign matter contamination. The products, which were produced between October 21 and November 4, were shipped to Alabama, Arizona, Arkansas, California, Georgia, Minnesota, Oklahoma and Pennsylvania.

Thus far there have been no confirmed reports of adverse reactions related to product consumption.

In an FSIS news release, the agency expressed concern that some of the products may be frozen at institutions and is advising that the products be thrown away or returned to where they were purchased.

Recall

Tyson Recall Affects 30,000+ Pounds of Frozen Chicken Patties

By Food Safety Tech Staff
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Recall

Yesterday Tyson Foods, Inc. announced a recall of its Weaver brand frozen chicken patties over concern that they could be contaminated with foreign materials. The Class I recall affects 39,078 pounds of frozen, fully cooked product that were produced on January 31 of this year and shipped to retailers nationwide. The recall was initiated after Tyson informed FSIS of consumer complaints.

Recall

Smoked Sausage Links and Organic Poultry Products Recalls Due to Foreign Matter Contamination

By Food Safety Tech Staff
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Recall

Last week USDA announced two Class I recalls involving possible foreign matter contamination. Perdue Foods, LLC has recalled about 31,703 pounds of certain ready-to-eat chicken products that may be contaminated with bone material. The products, which were shipped nationwide and include plastic trays of Simply Smart Organics Breaded Chicken Breast Tenders (gluten free and whole grain), and Chef Quik Breaded Chicken Tenders Boneless Tender Shaped Chicken Breast Patties with Rib Meat were produced on March 21. The full list of products is on the FSIS website and have the establishment number “EST. P-369” inside the USDA mark of inspection. Thus far there have been no confirmed reports of adverse reactions following consumption of these products.

Johnsville, LLC has recalled nearly 95,400 pounds of its ready-to-eat jalapeno cheddar smoked sausage products after a consumer complaint involving green hard plastic in the product. The 14-oz packages of the product were shipped both nationwide and internationally, were produced on March 12 and 13, and have the establishment number “EST. 34224” inside the USDA mark of inspection. Thus far there have been no confirmed reports of adverse reactions following consumption of these products.

magnifying glass

FDA, USDA Formally Agree to Regulate Human Food Made from Cells of Livestock and Poultry

By Food Safety Tech Staff
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magnifying glass

Today FSIS and FDA announced a formal agreement regarding the regulatory oversight of human food products derived from the cell lines of livestock and poultry. The agencies will jointly oversee regulation of these cell-cultured products to ensure both safe production as well as accurate labeling.

The agreement involves a joint regulatory framework in which the FDA will manage cell collection, cell banks, and cell growth and differentiation. During the cell harvest stage, FDA will transition oversight to FSIS and from there, FSIS will oversee production and labeling of the human food products that are derived from the cells of livestock and poultry.

“We recognize that our stakeholders want clarity on how we will move forward with a regulatory regime to ensure the safety and proper labeling of these cell-cultured human food products while continuing to encourage innovation,” said FDA Deputy Commissioner for Food Policy and Response Frank Yiannas in a USDA press release.

Alert

How the Government Shutdown Affects Food Safety

By Food Safety Tech Staff
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Alert

–UPDATE —January 9, 2019 – Today FDA Commissioner Scott Gottlieb, M.D. gave an update about food inspections in the context of the government shutdown. He chose Twitter to deliver his statement. He said FDA is expanding the scope of food safety surveillance inspections that are occurring during the shutdown to ensure that high-risk food facilities are address (31% of domestic inspections are high risk). He added that the agency continues to conduct all foreign food inspections.

“We assess risk based on an overall, cross-cutting risk profile. The primary factors contributing to a facility’s risk profile include: the type of food, the manufacturing process, and the compliance history of the facility. Commodities deemed high risk include, but aren’t limited to: modified atmosphere packaged products; acidified and low acid canned foods; seafood; custard filled bakery products; dairy products including soft, semi-soft, soft ripened cheese and cheese products, unpasteurized juices; sprouts ready-to-eat; fresh fruits and vegetables and processed fruits and vegetables; spices; shell eggs; sandwiches; prepared salads; infant formula; and medical foods.” – Scott Gottlieb, M.D., FDA

–END UPDATE–

As the third-longest government shutdown in U.S. history continues, businesses across industries are concerned about what resources are available.

At FDA, “All our work is important, but only some of our work is permitted to continue during a lapse in funding,” according to an agency statement. This work includes any activities that are considered “mission critical”:

  • Maintaining core functions that handle and respond to foodborne illness outbreaks
  • High-risk food recalls
  • Screening foods imported into the United States
  • The pursuit of civil and/or criminal investigations when the agency believes that the public health is at risk

At USDA, FSIS will continue much of its food safety activities Field inspection of meat, poultry and egg products will continue, as well as regulatory enforcement and product testing in labs. The agency will also continue its enforcement and food safety surveillance and investigations, which includes recall initiation, traceback/traceforward investigations.

“The agency must ensure adequate senior level management and coordination of the agency’s public health responsibilities during a shutdown. Excepted activities include responding to intentional and unintentional food safety events. A small number of individuals will support these activities for the duration of the shutdown, while others will be available on call if such an event occurs, including recall staff, scientists; recall communication specialists, significant incident specialists.” – USDA

In addition USDA/FSIS personnel at the agency’s three field labs are considered “excepted” during the shutdown. A full breakdown of FSIS activities that will continue are available on the USDA’s website.