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HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) TRAINING COURSE

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VIRTUAL COURSE

January 23, 2024 @ 12:00 pm – January 25, 2024 @ 12:00 pm

January 23, 2024 @ 12:00 pm – January 25, 2024 @ 12:00 pm

The Deibel Laboratories HACCP training program is designed to meet the USDA’s training requirements (9 CFR 417) and provides hazard analysis training for FDA regulated facilities that must have a FSMA mandated Food Safety Plan in place. Food Safety Plans must include an analysis of hazards with associated risk-based preventive controls. This course is accredited by the International HACCP Alliance. Participants receive a certificate with the HACCP Alliance seal upon completion of the course. The training program is conducted by our HACCP Alliance Lead Instructors.
Dr. Robert Deibel was one of the original pioneers of HACCP. He developed the HACCP concept from its original three HACCP principles to five, paving the way for the seven principles in place today. He also developed the first “HACCP Short Course” and pioneered training for industry leaders in the early 1970’s. We are proud of this history and continue this excellent tradition in the courses we teach today.

ABOUT THE COURSE
• This is a 2.5 day interactive virtual class that includes a HACCP Training Manual and a certificate with the HACCP Alliance seal.
• Participants will gain an understanding of HACCP systems and how they are used to manage and control the hazards encountered in food manufacturing facilities. This will include the development of a model HACCP plan
• Discussions will include how to perform a hazard analysis, conduct process validations, prepare for and develop HACCP plan audits, and establish pre-requisite program verifications.
• The integration of HACCP plans into FSMA mandated Food Safety Plans will also be discussed in relation to the FDA regulated food industry.

AT THE CONCLUSION, PARTICIPANTS WILL


• Understand the importance of HACCP Pre-requisite programs including GMPs, Pest Control and Sanitation.
• Be able to recognize the hazards that must be identified when conducting a hazard analysis.
• Learn how manage significant food safety hazards through the use of preventive controls and Critical Control Points (CCPs).
• Understand how to develop and implement a HACCP plan that manages identified hazards with associated controls, and maintains the effectiveness of those controls through verification and validation activities.

HACCP Instructors

Regulatory Watch Out!

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Use of Unapproved Food Additives – FDA’s Public Inventory

Any substance used or intended for use in food must be authorized by the FDA for use as a food additive under the Federal Food, Drug, and Cosmetic (FD&C) Act, unless the use of that substance is generally recognized as safe (GRAS) by qualified experts or qualifies for an exemption.


As part of its on-going compliance activities, FDA conducts post-market activities to monitor the food supply for chemical contaminants. FDA identifies foods that contain a substance for which there is no authorization as a food additive and then reviews the regulatory status of this substance. FDA scientists analyze whether there is a basis to conclude that the intended use of the substance is GRAS or meets a
listed exception to the food additive definition. When FDA scientists determine that a substance is an unapproved food additive because it is not GRAS for its intended use (and does not meet a listed exception), they deem the additive to be unsafe and any food that contains the additive is adulterated.

On July 12, 2023, FDA released a public inventory of certain food ingredients that do not have GRAS status as determined by the agency and are therefore deemed unsafe. The inventory is a useful tool to assure the use of authorized ingredients.


The FDA Concludes Voluntary Pilot Program to Evaluate Alignment of Third-Party Food Safety Standards
with FSMA Rules


Food manufacturers may find that they are required to comply with one of the Global Food Safety Initiative standards in addition to the FDA’s Preventive Controls for Human Food or Produce Safety Rules. The FDA recently concluded a voluntary pilot program to evaluate alignment of private third-party food safety audit standards including BRC, FSSC22000, SQF and Global G.A.P. with applicable FDA regulations.


The pilot program was launched to help both FDA and industry gain a better understanding of whether these standards align with FDA regulations. Alignment between these standards may allow a company to structure their food safety plan to eliminate redundancy in their documentation and auditing programs.

Buyers and others in the food supply-chain often use third-party audits to assess the quality and safety of a product. Buyers, such as importers and receiving facilities, might stipulate an audit as part of a purchase agreement. In addition, three FSMA regulations – the Preventive Controls for Human Food rule, Preventive Controls for Animal Food (PC Animal Food) rule, and Foreign Supplier Verification Programs (FSVP) rule – allow for third-party audits to be used as supplier verification activities. Points of alignment would provide confidence that, in general, the third-party standards used to audit suppliers adequately address applicable FDA food safety requirements.


The results of the pilot program can be found in The FDA Concludes Voluntary Pilot Program to Evaluate Alignment of Third-Party Food Safety Standards with FSMA Rules. The FDA’s statements regarding alignment of the standards are referenced in the table below and apply only to the specified audit standards and addenda listed.


The reviews listed in the table focused on assessing third-party food safety standards and not the overall quality of the audit programs or qualifications of auditors. The FDA’s review and the findings from this pilot do not constitute an endorsement of any one food safety audit standard, or audits conducted under such standards. The FDA also adds a qualifying statement that third-party audits are not a substitute for FDA or state regulatory inspections for compliance with FDA regulations, including the Preventive Controls for Human Food Rule or the Produce Safety Rule.

Third-Party Food Safety Audit Standard and Applicable
Addendum		Scope Name
BRC Global Standard Food Safety plus the Global Standard Food Safety,
Issue 9, Interpretation Guideline		Preventive Controls for Human Food (PCHF)
FSSC 22000 Scheme 5.1 for Food Manufacturing plus the FSSC 22000, Version 3 FSMA PCHF Report Addendum
Preventive Controls for Human Food (PCHF
SQF Food Safety Code: Food Manufacturing, Edition 9 plus the SQF
Addendum for the Preventive Controls for Human Food		Preventive Controls for Human Food (PCHF)
GLOBALG.A.P. Integrated Farm Assurance – All Farm Base Crops Base – Fruit and Vegetables Checklist. Version 5.4-1- GFS plus the GLOBALG.A.P. Food Safety Modernization Act Produce Safety Rule Add-on Module Version 1.3Produce Safety Rule (PSR)
*Did not include Subpart E, related to Agricultural Water (as applicable to non-sprout produce) or Subpart M, related to sprouts

Current Recall a Reminder of Past Incident Involving Frozen Vegetables Contaminated with Listeria monocytogenes

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A new recall of frozen vegetables was published on August 23, 2023, due to the finding of Listeria monocytogenes in sweet cut corn. Recalled products were distributed to major retailers across the U.S. having best by dates as far away as December 2024. Listeria monocytogenes, like many pathogens, will not be eliminated by freezing and will persist in the frozen product. While little information is given in the recall, findings from a 2016 listeriosis outbreak involving frozen vegetables is highlighted in the following.


In 2016, the first multistate outbreak of L. monocytogenes involving frozen vegetables occurred in the U.S. Initially three persons reported illness in 2016, but six more illnesses occurring between 2013 – 2015 were identified using PulseNet traceback data. Two outbreak strains were identified in patients ranging in age from 56 to 91 years and three deaths were reported.


Routine sample of frozen vegetables, and the use of whole genome sequencing (WGS), revealed that eight illnesses were closely related to a strain found in frozen organic white sweet cut corn and one illness to a strain found in frozen organic petite green peas produced by CRF Frozen Foods of Pasco, WA. At the same time, an investigation of the Oregon Potato Company of Pasco, WA found that environmental samples matched the whole genome sequence associated with the eight clinical cases and the CRF frozen organic white sweet cut corn. However, a connection between the companies is unknown because the FDA is prohibited by law from releasing publicly certain information about supply chains, which may constitute confidential commercial information.


A recent publication describes the investigational findings by federal and state regulatory agencies at the two frozen vegetable manufacturers. Observations at the CRF Frozen Foods’ facility indicated that the materials and design of equipment and utensils did not allow proper cleaning and maintenance, and could be potential sources of contamination. An investigation of the facility did not find L. monocytogenes in the environment, but L. innocua was found in zones 1 – 3 which FDA considers evidence of conditions that would be suitable for L. monocytogenes.


Seven L. monocytogenes positive zone 1 swabs, two positive zone 2 swabs, ten positive zone 3 were found in the Oregon Potato Company’s facility. Two of these positives, one zone 1 swab and one zone 3 swab,- matched an outbreak strain also found in CRF’s frozen organic white sweet cut corn. Inspectional observations made include:

  • failure to clean food‐contact surfaces as frequently as necessary to protect against contamination
  • facility construction that did not prevent condensate from contaminating food‐contact surfaces
  • food‐contact surfaces not adequately cleaned and sanitized
  • failure to maintain physical facilities in a sanitary condition
  • facility construction not allowing adequate cleaning of floors and walls

A FDA warning letter was issued and noted the presence of L. monocytogenes in the facility as being indicative of inadequate sanitation efforts to effectively control pathogens in the facility. Although these products are considered not ready‐to‐eat, many consumers may use these products
without proper cooking. Cooking instructions should be clear and validated, and consumers should be informed that consuming undercooked or uncooked frozen vegetables could lead to foodborne illness.

IAFP 2023 – Intentional Adulteration (IA) Rule – Update

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The IAFP Food Defense PDG heard a regulatory update on the
Intentional Adulteration (IA) Rule at the annual meeting in Toronto.
Colin Barthel, a policy analyst at FDA (FDECS, OAO, CFSAN) discussed the status of ongoing Food Defense Plan Quick Checks, the Food Defense Plan Builder version 2.0, and what’s next for future full Food Defense Plan inspections.


Food Defense Plan Quick Checks have been occurring during Food Safety (Preventive Controls) inspections conducted by FDA since October 2020. Inspectors assess if a firm is subject to the IA Rule and conduct a visual inspection for presence or absence of a Food Defense Plan. Currently, about 1,000 Quick Checks have been conducted with 70% occurring at domestic facilities and 30% at foreign facilities. Sixty percent of facilities have used the Key Activity Types to conduct their vulnerability assessment while 5% of facilities did not do a vulnerability assessment or have a Food Defense Plan in place.

The Food Defense Plan Builder version 2.0 is a user-friendly tool available to help owners and operators of a food facility to develop a food defense plan that is specific to their facility and meet the requirements of the IA Rule. It has been downloaded 11,489 times. This is more than the estimated 10,000 registered
domestic facilities revealing that many others are also finding this tool useful. The FDA is accepting feedback on the Food Defense Plan Builder version 2.0 for use in updating a future version.


Next steps for FDA involve developing a Food Defense Inspection Team to begin conducting full Food Defense Plan inspections in the next fiscal year. A supervisor for the team was hired and five investigators are to be trained over the next 12 months to conduct full inspections. The FDA identified 25-30 factors that will be used to identify facilities that will be prioritized for full inspection. Currently, all FDA inspections are transitioning to be unannounced. Violations occurring in full Food Defense Plan inspections will be handled as they are for Preventive Controls inspections; they will begin with a FDA form 482 and end with a FDA form 483 being issued.

IA Rule regulatory requirements for covered facilities include the need for a Food Defense Plan. Components of the Plan are a vulnerability assessment; implemented mitigation strategies; documented monitoring activities, corrective actions, and verification procedures. Training and recordkeeping are also requirements. More information is available on FDA’s website. The Food Defense Plan is overseen by a Food Defense Qualified Individual. Training developed to align with regulatory requirements is available from FSPCA.


Resources to assist industry comply with the IA Rule include:

FDA Releases Findings on RTE Dips and Spreads

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In 2021, the U.S. Food and Drug Administration (FDA) conducted a routine assignment to collect domestic multi-commodity ready-to-eat (RTE) refrigerated dips and spreads to test for Listeria monocytogenes and Salmonella spp. The agency’s goal in conducting this assignment was to determine the prevalence of these pathogens in RTE dips and spreads and remove adulterated products from the market, when possible.

The assignment, which ran from March 2021 to January 2022, found that four out of the 747 samples tested were contaminated with Salmonella or L. monocytogenes. Ready-to-eat foods can become contaminated with environmental pathogens from harborage sites in the food manufacturing environment or process. Cross-contamination from ingredients can also occur.   Additionally, dips and spreads often have a pH and water activity that favor bacterial survival and outgrowth.  Consumers typically eat these dips and spreads without a ‘kill step,’ such as cooking, to reduce or eliminate any pathogenic bacteria that may be present. As such, dips and spreads contaminated with L. monocytogenes or Salmonella can present a significant public health risk. Ready-to-eat dips such as hummus and cheese spreads have been associated with multiple recalls over the past few years. The FDA’s assignment was initiated due to five recalls of hummus products and six recalls of multi-commodity dips found to be contaminated with L. monocytogenes or Salmonella from FY2017 through FY2020.

During the sampling assignment, the FDA identified Salmonella Havana in a sample of hummus from a retail establishment in California.  The FDA notified the manufacturer of the hummus and a recall was initiated.  The FDA conducted a follow-up inspection at the manufacturer of the contaminated product to evaluate the firm’s manufacturing operations and collect environmental samples. The FDA found that the firm did not establish and implement adequate written procedures for monitoring sanitation control procedures (i.e., cleanliness of food-contact surfaces). The environmental samples collected at the follow-up inspection did not yield any positive pathogens, however, the agency still issued a warning letter after the follow-up inspection.  After taking corrective actions, the firm was unable to identify a root cause for the Salmonella Havana contamination in the hummus.

The FDA identified L. monocytogenes in three samples from a retail establishment in Colorado and the agency notified the firm where the positive samples were manufactured. All three of the samples contaminated with L. monocytogenes were produced by the same manufacturer. Upon notification of the contaminated samples, the firm recalled and destroyed the products associated with the positive findings. The agency issued a Consumer Advisory in conjunction with the firm’s recall.

The agency conducted a follow-up inspection at the manufacturer of the three contaminated products. The follow-up inspection sought to evaluate the firm’s manufacturing operations and collect environmental samples to determine potential sources and routes of contamination. The FDA found L. monocytogenes in 23 swabs collected within the production environment, including samples collected from food contact surfaces. WGS analysis was conducted on the L. monocytogenes isolates obtained from both the retail product samples and the inspection environmental samples. The isolates were a genomic match to each other.

The FDA’s follow-up inspection determined the firm’s employees were not trained in food safety or hygiene practices and found multiple instances of deficient sanitation practices related to equipment, utensils, and employees. The agency determined that the firm did not respond appropriately to the positive samples identified in the sampling assignment and had not addressed objectionable conditions observed by the FDA during a previous 2020 inspection.  The firm went out of business at the end of June 2021.

Underscored in the FDA’s report is the necessity for manufacturing firms to have good manufacturing practices in place, as well as a proper environmental monitoring program and adequate training for its staff as part of their standard business operating procedures.

Deibel Laboratories has years of experience in conducting shelf-life studies, formulation reviews, and validations for refrigerated dips and spreads.  Our staff of industry experts is ready to assist you in assuring that your manufacturing processes and facilities comply with the stringent food safety standards required by the FDA and USDA.  With a complete suite of accredited pathogen testing methods and the testing capacity of 15 laboratories strategically placed throughout North America, Deibel Laboratories is your one-stop for assuring food safety compliance.

Contact us at Sales@DeibelLabs.com for more information about a laboratory near you. Visit us at https://deibellabs.com/services/deibel-guardianemp/ to learn more about our environmental monitoring program, Deibel GuardianEMPsm. Link to FDA findings: FY21-22 Sample Collection and Analysis of Domestic Refrigerated RTE Dips and Spreads | FDA