Tag Archives: FDA

Earl Arnold, AIB International
FST Soapbox

HACCP is the Past, Present and a Building Block for the Future

By Earl Arnold
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Earl Arnold, AIB International

“Food safety plan” is a term often used in the food industry to define an operation’s plan to prevent or reduce potential food safety issues that can lead to a serious adverse health consequence or death to humans and animals to an acceptable level. However, depending on the facility, their customers, and or regulatory requirements, the definition and specific requirements for food safety plans can be very different. To ensure food safety, it’s important that the industry finds consensus in a plan that is vetted and has worked for decades.

One of the first true food safety plans was HACCP. Developed in 1959 for NASA with the assistance of the food industry, its goal was to ensure food produced for astronauts was safe and would not create illness or injury while they were in space. This type of food safety plan requires twelve steps, the first five of which are considered the preliminary tasks.

  1. Assemble a HACCP team
  2. Describe the finished product
  3. Define intended use and consumer
  4. Create process and flow diagram
  5. Verify process and flow diagrams

This is followed by the seven principles of HACCP.

  1. Conduct the hazard analysis
  2. Identify critical control points
  3. Establish critical limits
  4. Establish monitoring requirements
  5. Establish corrective actions for deviations
  6. Procedures for verification of the HACCP plan
  7. Record keeping documenting the HACCP system

HACCP is accompanied by several prerequisites that support the food safety plan, which can include a chemical control program, glass and brittle plastics program, Good Manufacturing Practices (GMPs), allergen control program, and many others. With these requirements and support, HACCP is the most utilized form of a food safety plan in the world.

When conducting the hazard analysis (the first principle of HACCP), facilities are required to assess all products and processing steps to identify known or potential biological, chemical and physical hazards. Once identified, if it is determined that the hazard has a likelihood of occurring and the severity of the hazard would be great, then facilities are required to implement Critical Control Points (CCP) to eliminate or significantly reduce that identified hazard. Once a CCP is implemented, it must be monitored, corrective actions developed if a deviation in the CCP is identified and each of these are required to be verified. Records then also need to be maintained to demonstrate the plan is being followed and that food safety issues are minimized and controlled.

HACCP is, for the most part, the standard food safety plan used to meet the Global Food Safety Initiative (GFSI) standards. This is utilized in various third-party audit and customer requirements such as FSSC 22000, SQF, BRC, IFS and others. These audit standards that many facilities use and comply with also require the development of a food safety management system, which includes a food safety plan.

Further, HACCP is often used to demonstrate that potential food safety issues are identified and addressed. FDA has adopted and requires a regulated HACCP plan for both 100% juice and seafood processing facilities. USDA also requires the regulated development of HACCP for meat processing and other types of facilities to minimize potential food safety issues.

For facilities required to register with the FDA—unless that facility is exempt or required to comply with regulated HACCP—there is a new type of food safety plan that is required. This type of plan builds upon HACCP principles and its steps but goes beyond what HACCP requires. Under 21 CFR 117, specific additions assist in identifying and controlling additional food safety hazards that are on the rise. This includes undeclared allergen recalls, which constituted 47% of recalls in the last reportable food registry report published by FDA.

Prior to developing this plan, FDA provided recommendations for preliminary steps that can be completed and are essential in development of a robust food safety plan but are not a regulatory requirement. The steps are very similar to the preliminary tasks required by HACCP, including the following:

  1. Assemble a food safety team
  2. Describe the product and its distribution
  3. Describe the intended use and consumers of the food
  4. Develop a flow diagram and describe the process
  5. Verify the flow diagram on-site

Their recommended plan also requires a number of additional steps, including:

  1. A written hazard analysis. Conducted by or overseen by a Preventive Controls Qualified Individual (PCQI). However, this hazard analysis requires assessing for any known or reasonably foreseeable biological, chemical, physical, radiological, or economically motivated adulteration (food fraud that historically leads to a food safety issue only). You may note that two additional hazards—radiological and EMA—have been added to what HACCP calls for in the assessment.
  2. Written preventive controls if significant hazards are identified. However, similar preventive controls are different than a CCP. There are potentially four types of preventive controls that may be utilized for potential hazards, including Process Preventive Controls (the same as CCP), Allergen Preventive Controls, Sanitation Preventive Controls, Supply Chain Preventive Controls and Others if identified.
  3. A written supply chain program if a Supply Chain Preventive Control is identified. This includes having an approved supplier program and verification process for that program.
  4. A written recall plan if a facility identified a Preventive Control.
  5. Written monitoring procedures for any identified Preventive Control that includes the frequency of the monitoring what is required to do and documenting that monitoring event.
  6. Written corrective actions for identified Preventive Controls in case of deviations during monitoring. Corrective actions must be documented if they occur.
  7. Written verification procedures as required. This could include how monitoring and corrective actions are verified, procedures themselves are verified, and calibration of equipment as required. Also required is training, including a Preventive Control Qualified Individual. Additional training is required for those individuals responsible for performing monitoring, implementing corrective actions, and verification of Preventive Controls. Further, all personnel need to have basic food safety training and all training needs to be documented.

While the term “food safety plan” is used widely, it’s important that operations don’t just use the term, but enact a plan that is vetted, proven to work, and encompasses the principles of HACCP. Doing so will help ensure that their facility is producing foods that customers and consumers will know is safe.

FDA

In a Year of ‘Unprecedented Challenges’ FDA’s Food Program Achieved So Much

By Food Safety Tech Staff
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FDA

Earlier this week FSMA celebrated its 10-year anniversary, and FDA Deputy Commissioner for Food Policy and Response Frank Yiannas reflected on the progress and accomplishments as a result of this legislation, and the path forward. As we round out the first week of 2021, Yiannas is looking back at the achievements of 2020 in the face of the historic COVID-19 pandemic.

“I’m struck by how tirelessly our team members have worked together to help ensure the continuity of the food supply chain and to help keep food workers and consumers alike safe during the COVID-19 pandemic,” said Yiannas on the FDA Voices blog. “Their commitment has not wavered in a time when we’re all dealing personally with the impact of the pandemic on our families, schooling our children from home and taking care of elderly parents.”

  • Response to COVID-19. FDA addressed the concern of virus transmission, assuring consumers that COVID-19 cannot be transmitted via food or its packaging. The agency also worked with CDC and OSHA on resources to help promote worker safety and supply chain continuity.
  • Release of the New Era of Smarter Food Safety Blueprint
  • Release of the 2020 Leafy Greens STEC Action Plan with a focus on prevention, response and research gaps
  • Artificial Intelligence pilot program to strengthen the screening of imported foods
  • Proposed Food Traceability Rule issued in an effort to create more recordkeeping requirements for specific foods
  • New protocol for developing and registering antimicrobial treatments for pre-harvest agricultural water
  • Enhanced foodborne outbreak investigation processes and established the outbreak investigation table (via the CORE Network) to disseminate information about an outbreak right when the agency begins its investigation
Susanne Kuehne, Decernis
Food Fraud Quick Bites

Many Bad Apples Spoil the Bunch

By Susanne Kuehne
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Susanne Kuehne, Decernis
Rotten apples
Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit: Susanne Kuehne

Food fraud can have a substantial impact on a consumer’s health, like in this case of fruit juice that was sold (including to school lunch programs) in spite of contamination with arsenic and mycotoxins. The fruit used for the juice was decomposing, and also processed in a facility that unacceptably violated hygiene and food safety standards. The FDA filed a lawsuit against the company, which in the meantime has ceased operations.

Resource

  1. Vigdor, N. (November 10, 2020) “School Lunch Program Supplier Sold Juice With High Arsenic Levels, U.S. Says in Lawsuit”. The New York Times.

 

Recall

Q3 Food and Beverage FDA Recalls Up 34% Over Q2, USDA Recalls at Record Low

By Food Safety Tech Staff
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Recall

It is being speculated that the short-term decline in the number of food and beverage recalls this year is due to less regulatory oversight as a result of the COVID-19 pandemic. During Q3, FDA food recall activity was up 34% compared to last quarter, but this increase is actually a sign of things returning to normal on the side of regulatory oversight activities, according to the latest Q3 Recall Index from Stericycle.

FDA Food Recalls: Notable Numbers (Q3 2020)

  • Undeclared allergens: 56 recalls, accounting for nearly 53% of all recalls; the top cause of an FDA food recalls for the 13th consecutive quarter
  • Bacterial contamination: Accounting for 62% of recalled units, this was the top cause of recalled units with Salmonella being the most common contaminant (the pathogen was responsible for 17 out of 24 recalls)
  • Foreign materials, quality and mislabeling were the other reasons for recalls

USDA Recalls: Notable Numbers (Q3 2020)

  • Undeclared allergens: Top cause of recalls; 6 recalls accounted of nearly 70% of all recalled pounds
    • A single meat and poultry recall affected more than 242,000 pounds (63%) of all recalled pounds
  • The average recall affected 38,000 pounds
  • Over the last three quarters, recalls have been at record low levels
    • Quarterly recall activity is averaging 8.3 recalls a quarter versus an average quarterly volume of more than 30 recalls over the last five years
FDA

FDA’s New Outbreak Table an Effort Toward Earlier Transparency about Outbreaks

By Food Safety Tech Staff
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FDA

FDA has released an outbreak investigation table that aims to disseminate information about foodborne illness outbreaks right when the agency begins an investigation. The table, published by the FDA’s Coordinated Outbreak Response and Evaluation (CORE) Network, will be updated with important information before a public health advisory or food recall is issued.

“The outbreak investigation table is a demonstration of our continued commitment to more frequent and transparent communication with stakeholders and consumers about outbreaks we’re investigating,” said Frank Yiannas, deputy commissioner for food policy and response at FDA, in an agency statement. “We have already taken steps to release information early, in some cases prior to a specific food being linked to an outbreak, including in our recent communications on investigations into three ongoing E. coli O157:H7 outbreaks.”

As of November 18, the table listed seven outbreak investigations, only one of which identified a product linked to illnesses. Yiannas pointed out that during the early stages of an investigation, there may not be any action that a consumer can take—however, the tool is in line with the New Era of Smarter Food Safety initiative, which commits to releasing outbreak information in the “earliest stages of an investigation”.

The FDA’s outbreak investigation table is available on the agency’s website.

Food Safety Consortium

2020 FSC Episode 11 Preview: Supply Chain Management

By Food Safety Tech Staff
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Food Safety Consortium

This week’s episode of the 2020 Food Safety Consortium Virtual Conference Series will address how food companies can navigate supply chain complexities. The following are highlights for Thursday’s session:

  • Disruptions in the Supply Chain and the Government Response, with Brian Ravitch and Benjamin England, FDA Imports
  • Food Safety Risks and the Cold Supply Chain, with Jeremy Schneider, Controlant
  • A panel discussion on the Third-Party Certification Program, moderated by Trish Wester, AFSAP and featuring Doriliz De Leon and Clinton Priestly of FDA
  • TechTalk on How Restaurant Brands International has Digital Transformed Its Supply Chain to Ensure Food Safety, Quality & Consistency, with Jim Hardeman, CMX

The event begins at 12 pm ET on Thursday, November 19. Haven’t registered? Follow this link to the 2020 Food Safety Consortium Virtual Conference Series, which provides access to all the episodes featuring critical industry insights from leading subject matter experts! We look forward to your joining us virtually.

Tucson Tamale

USDA Issues Public Health Alert for Tamales Due to Potential Foreign Matter Contamination

By Food Safety Tech Staff
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Tucson Tamale

Yesterday USDA’s FSIS issued a public health alert for ready-to-eat chicken and pork tamales because they contain recalled diced tomatoes in puree that have been recalled by the producer due to foreign matter contamination. The puree product is FDA regulated. The RTE tamales were produced by Tucson Tamale Wholesale Co., LLC between October 22 and November 9, 2020, and have the establishment number “EST. 45860” inside the USDA mark of inspection. The products were sold online and shipped for retail and restaurant distribution nationwide.

Tucson Tamale
Tucson Tamale recalled the above-pictured ready-to-eat tamales due to potential contamination with hard plastic.

Tucson Tamale uncovered the issue upon identifying pieces of hard plastic in the cans of diced tomatoes that they received from their ingredients supplier. FSIS is urging consumers who purchased the product to throw them away or return them to the place of purchase.

Tanimura & Antle romaine lettuce

Romaine Lettuce Recall Due to Possible E. Coli Contamination

By Food Safety Tech Staff
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Tanimura & Antle romaine lettuce
Tanimura & Antle romaine lettuce
Tanimura & Antle issued a voluntary recall of single-head packaged romaine lettuce.

Tanimura & Antle, Inc. is voluntarily recalling its packaged single head romaine lettuce, out of an abundance of caution, due to possible E. Coli 0157:H7 contamination. The product has a packaged date of 10/15/2020 or 10/16/2020, and the UPC number 0-27918-20314-9.

Although no illnesses have been reported, the recall is based on the test result of a random sample taken and analyzed by the Michigan Department of Agriculture and Rural Development. The company distributed 3,396 cartons to 20 states. Retailers and distributors can identify the affected products using the Product Traceability Initiative stickers (571280289SRS1 and 571280290SRS1) that are attached to the exterior of the case.

FDA

FDA Releases More Resources for Food Traceability Proposed Rule, Risk-Ranking Model for Food Tracing

By Food Safety Tech Staff
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FDA

Yesterday FDA released more resources to help stakeholders in understanding the FSMA Food Traceability proposed rule. The Risk-Ranking Model for Food Tracing is designed to help users learn more about the methods and criteria for scoring commodity-hazard pairs, along with the results of the scoring that are used to determine the foods included on the Food Traceability List [https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list].

The agency also published a pre-recorded webinar about the proposed rule, featuring Frank Yiannas, deputy commissioner for food policy and response, and Angela Fields, a traceability expert with FDA’s Coordinated Outbreak Response and Evaluation Network.

Other resources include a flowchart to assist with determining who is subject to the rule and a glossary of key terms.