Category Archives: HACCP

Research – High Genetic Diversity and Virulence Potential in Bacillus cereus sensu lato Isolated from Milk and Cheeses in Apulia Region, Southern Italy



The Bacillus cereus group includes species that act as food-borne pathogens causing diarrheal and emetic symptoms. They are widely distributed and can be found in various foods. In this study, out of 550 samples of milk and cheeses, 139 (25.3%) were found to be contaminated by B. cereus sensu lato (s.l.). One isolate per positive sample was characterized by Multilocus Sequence Typing (MLST) and for the presence of ten virulence genes. Based on MLST, all isolates were classified into 73 different sequence types (STs), of which 12 isolates were assigned to new STs. Virulence genes detection revealed that 90% and 61% of the isolates harboured the nheABC and the hblCDA gene cluster, respectively. Ninety-four percent of the isolates harboured the enterotoxin genes entS and entFM; 8% of the isolates possessed the ces gene. Thirty-eight different genetic profiles were identified, suggesting a high genetic diversity. Our study clearly shows the widespread diffusion of potentially toxigenic isolates of B. cereus s.l. in milk and cheeses in the Apulia region highlighting the need to adopt GMP and HACCP procedures along every step of the milk and cheese production chain in order to reduce the public health risk linked to the consumption of foods contaminated by B. cereus s.l.

UK – APHA part of 5 UK E. coli outbreaks in 2022

Food Safety News

The Animal and Plant Health Agency (APHA) was involved in another two E. coli outbreaks in the United Kingdom in the final quarter of 2022.

In the first, APHA helped Public Health Wales investigate two human cases of Shiga toxin-producing E. coli (STEC) O145 linked to a private collection of animals on a smallholding. Multiple species were onsite including cattle, goats, deer, and pigs. Some food consumed by people was grown in the garden where cattle manure was used. Thirty environmental fecal samples were collected but a match to the outbreak strain was not found.

In the second, APHA visited an open farm at the request of an incident management team following an outbreak of E. coli O157 in people. The outbreak strain was detected in one environmental sample from a pig enclosure. The incident is ongoing so it is unclear how many people are sick. The advice was provided to reduce the risk to the public by making improvements to the supervision of animal contact, enhancing handwashing facilities, and improving some animal exhibits.

In all of 2022, APHA was part of five E. coli investigations. The agency helped the UK Health Security Agency (UKHSA) investigate E. coli O103, O145, and O26 outbreaks between July and September.

The E. coli O26 outbreak also involved cryptosporidium. There were 11 cases of cryptosporidium and two people had confirmed E. coli O26. Cryptosporidium patients had visited an open farm attraction during the incubation period of illness. The E. coli patients had links to the same premises.

The E. coli O103 outbreak with 11 cases was associated with soft, raw milk cheese from a dairy farm in the East of England. Pasteurization was put in place for the production of the soft cheese, HACCP processes were reviewed, and enhanced control measures were taken.

The E. coli O145 outbreak with 10 patients was traced to the consumption of milk products from a dairy farm in North West England, with illness onset from mid-July. Investigations identified an issue with pasteurization and problems with the cleaning and storage of milk crates.

Research – Implementation of the HACCP System for Apple Juice Concentrate Based on Patulin Prevention and Control



Patulin (PAT) is a toxic secondary metabolite produced by Aspergillus sp. and Penicillium sp., which acts as a contaminant of most apples and their products. The internationally recognized HACCP system is selected as the theoretical basis to more effectively reduce the PAT in apple juice concentrate (AJC). Through field investigation of apple juice concentrate (AJC) production enterprises, we collected 117 samples from 13 steps of AJC production, including whole apple, apple pulp, and apple juice. PAT contents were analyzed via high-performance liquid chromatography (HPLC) and compared with samples from the different production processes. The result demonstrated that the PAT content was significantly (p < 0.05) influenced by five processes, receipt of raw apples, sorting of raw apples, adsorption step, pasteurization, and aseptic filling. These processes were determined as the CCPs. Monitoring systems for maintaining CCPs within acceptable limits were established, and corrective actions were proposed in case a CCP was surpassed. Based on the above-identified CCPs, critical limits, and control methods (corrective actions), a HACCP plan related to the production process of AJC was established. This study provided important guidance for juice manufacturers wishing to effectively control the PAT content in their products.

Research – Pre-Harvest Strategies to Reduce Foodborne Pathogens in Red Meat Production

Food Safety Magazine

Consumers expect and rightfully demand a plentiful supply of affordable, safe, and wholesome red meat. Concerns about the safety of meat have been important to the industry, the public, and the government since the implementation of the Pure Food and Drug Act of 1906. Unfortunately, despite the effort expended in controlling foodborne illnesses in the U.S., foodborne pathogens cost the GDP more than $17.6 billion each year in direct and indirect costs.1

One of the most notable improvements to food safety is the implementation of Hazard Analysis and Critical Control Points (HACCP), which has been globally adopted as a method to systematically improve food safety. The implementation of other procedures, such as “test and hold” for ground beef prior to shipment to consumers, has significantly improved consumer safety. As a result of these systematic improvements in the food supply chain driven by industry and government actions, the U.S. food supply is safer than ever before.

Read more at the link above

USA – FDA Warning Letter – Bainbridge Beverage West, LLC- Microbial Risk


The U.S Food and Drug Administration (FDA) inspected your juice manufacturing facility, located at 2335 Del Monte Street, West Sacramento, CA 95691 on June 9, 10, 22, 24, and 29, 2022. We found that you have serious violations of the FDA’s juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120). In accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP plan that complies with the requirements of 21 CFR Part 120 renders the juice products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)]. Accordingly, your juice products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act, FDA’s juice HACCP regulations and the Juice HACCP Hazards and Controls Guidance through links in FDA’s home page at Link Disclaimer

To date, the agency has not received a written response from your firm regarding the violations noted on the Form FDA-483, Inspectional Observations, which was issued to your firm at the conclusion of the inspection.

Research – An Evaluation of Food Safety Performance in Wineries


Wine production has food safety hazards. A Hazard Analysis Critical Control Point (HACCP) system makes it possible to identify, evaluate, and control significant food safety hazards throughout the wine production process. The Prerequisites Programs (PPRs) and HACCP performance in Protected Denomination of Origin “Vinos de Madrid” wineries were analyzed. Winery performances were evaluated for every critical control point (CCPs) in each winemaking process stage, including their implementation of PPR and HACCP principles. This study was developed through a survey of 55 questions divided into 11 sections, and it was conducted on a sample of 21 wineries. The results revealed that the CCPs worst performance level are for the control of metals (Cd, Pb, As) in grapes and fungicides or pesticide control in the harvest reception. A total of 91.5% of the wineries had implemented a prerequisites program (PPRs), regardless of their annual wine production. However, there was variability in the type of prerequisite plans, training, level of knowledge of operators, and annual budget allocation. Three out of four wineries had an HACCP, although corrective action procedures and verification procedures had the lowest and the worst HACCP practical implementation. The significant barriers for HACCP performance in wineries are linked with a lack of food safety staff training, low involvement of all staff in food safety tasks, and poor application of CCP chemical and microbiologic control methods.

USA -FDA Warning Letter – 5,000 Years Foods, Inc.


The U.S. Food and Drug Administration (FDA or we) inspected your kimchi operation located at 3465 N. Kimball Ave, Chicago, IL 60618 from June 14, 2021 through August 3, 2021. FDA conducted this inspection as a follow up to the Regulatory Meeting held with your firm on February 21, 2019.

During the inspection, FDA investigators found serious violations, described below, of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, FDA issued an FDA Form 483, Inspectional Observations, listing deviations found at your facility.

Based on FDA’s inspectional findings, we have determined that the ready-to-eat kimchi products manufactured in your facility are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Codes (U.S.C.) § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. In addition, failure to comply with the requirements under Section 418 of the Act [21 U.S.C. § 350h] is a prohibited act under section 301(uu) of the Act [21 U.S.C. § 331(vv)]. You can find the Act and FDA’s regulations through internet links in FDA’s home page at Link Disclaimer

We received your written responses dated July 3, 2021, and August 17, 2021, which included a summary of corrective actions by your facility. After reviewing the inspectional findings and your response to the observations listed in the FDA Form 483, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.

Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):

1. Your hazard analysis did not evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control for your ready-to-eat kimchi products (e.g., sliced cabbage kimchi, cube cut radish kimchi, and white whole kimchi), as required by 21 CFR 117.130(a). Your “Hazard List” consisted of a number of potential hazards but did not evaluate which ones actually require a preventive control. Specifically:

a. You did not evaluate environmental pathogens, such as Listeria monocytogenes, to determine whether they are a hazard requiring a preventive control, to comply with 21 CFR 117.130(c)(1)(ii). For example, you manufacture ready-to-eat sliced cabbage kimchi which is exposed to the environment at the steps of cabbage halving, brining, rinsing, draining, chopping, mixing with sauce, and packaging. The kimchi does not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. Thus, environmental pathogens are a hazard likely to occur in the absence of preventive controls (i.e., sanitation controls). Your “Hazard List” identified but did not otherwise evaluate contamination from the “food handling environment.”

We note that at the start of the inspection, your written procedures for sanitation of food-contact surfaces consisted of a generic “Cleaning and Disinfection” document downloaded from the internet, which indicated general tips for completing and checking sanitation tasks. The document was not specific to your facility or food. In addition, your monitoring record was a general-facility (b)(4) “Cleaning Record” which did not specify what was being cleaned or monitored and which was not subject to record review. Further, deficiencies in your sanitation monitoring are evidenced by FDA investigators’ observations on June 14-15, 2021, that the (b)(4) that was cleaned, sanitized, and deemed ready for production of ready-to-eat kimchi had apparent food residue on the blades and behind the feed mechanism used to push the (b)(4) through the (b)(4) blades.

During the closeout meeting at the end of the inspection, you provided an updated blank sanitation monitoring record (“Environm[en]tal Cleaning & Sanitizing Log”) with a statement at the top on how to clean and sanitize specific pieces of food-contact equipment such as the (b)(4), cutting boards, preparing tables, utensils, and kimchi mixer. The form did not cover your tanks for cabbage brining and mixing. The form instructed to clean with soap and water but did not describe the type and concentration of soap or the tools and technique for cleaning. The form instructed to sanitize the equipment “using a mixture of (b)(4) of (b)(4) to (b)(4)” but did not actually describe how to sanitize the equipment with the solution.

FDA’s current inspection included the collection of environmental swabs on June 15, 2021, during the production of ready-to-eat kimchi, and confirmed five (5) of sixty-six (66) swabs positive for Listeria monocytogenes. Of the positive findings, three (3) swabs were collected from areas adjacent to food-contact surfaces where RTE ingredients were being prepared, including:

• Topside of a large white cutting board used to hold baskets of cabbage for draining after brining and rinsing. During our inspection, cabbage was observed hanging off the side of the baskets and in direct contact with cutting boards.
• Underside of a white cutting board was used to hold draining baskets of cabbage.
• Side of wet and difficult to clean wooden crate used to hold cutting boards that were holding the draining baskets of cabbage.

Whole genome sequencing (WGS) was conducted on the above referenced L. monocytogenes isolates obtained from the FDA environmental samples. Based on the results of the WGS analysis, the environmental samples collected at your facility represent one (1) unique strain. We advised you of the importance of these WGS results via a conference call on September 10, 2021.

L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans or equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the areas of the food processing plant where this organism is able to survive, and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.

Note that environmental monitoring is required when contamination of a ready-to-eat food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR 117.165(a)(3)). Environmental monitoring is used to verify that sanitation preventive controls are designed and functioning to reduce the hazard of environmental pathogens such as Listeria monocytogenes contaminating your finished product.

UK – Hazard Analysis and Critical Control Point (HACCP)


HACCP is a way of managing food safety hazards. Food safety management procedures should be based on HACCP principles.

HACCP involves:

  • looking closely at what you do in your business, what could go wrong and what risks there are to food safety
  • identifying any critical control points the areas a business needs to focus on to ensure those risks are removed or reduced to safe levels
  • deciding what action you need to take if something goes wrong
  • making sure that your procedures are being followed and are working
  • keeping records to show your procedures are working

It is important to have food safety management procedures that are appropriate for your business.

Explaining hazards

A hazard is something that is dangerous. A food hazard is something that could make food unsafe or unfit to eat. It’s important you can identify those stages in your business when hazards could be present so they can be removed or reduced to safe levels.

There are three main types of food safety hazards:

  • microbiological – involving harmful bacteria
  • chemical – involving chemical contamination
  • physical – involving objects getting into food

Food safety management procedures

You must develop your own procedures based on the principles of HACCP.

Businesses must comply with the legal requirements by following good hygiene practice.

HACCP system in meat plants

Meat plants are required to implement and maintain hygiene procedures based on Hazard Analysis and Critical Control Point (HACCP) principles for meat plants.


MyHACCP is a free web tool that will guide you through the process of developing a food safety management system based on the HACCP principles.

This tool will produce a food safety management system for your business. This will show how your business can identify and control any hazards that occur in the food you manufacture.

MyHACCP is aimed at small food manufacturing businesses in the UK. This can include businesses with fifty or fewer employees. Access to the tool is not available to food businesses outside the UK.

MyHACCP step by step

You will need to:

  • sign up for a MyHACCP account(Opens in a new window)
  • start the process at the beginning or at any point – you can come back and finish it at any time
  • complete the MyHACCP process – you can preview what the output will look like at any stage
  • print or download the completed food safety management system documents for your records

Smaller businesses and retailers

Our Safer Food Better Business (SFBB) or Safe Catering (Northern Ireland) packs provide a simpler approach if your food production processes are simple.

Research – Application of peroxyacetic acid for decontamination of raw poultry products and comparison to other commonly used chemical antimicrobial interventions – A Review

Journal of Food Protection

Poultry remains one of the top food commodities responsible for foodborne illness in the U.S., despite poultry industry efforts since the inception of HACCP to reduce the burden of foodborne illness implicating poultry products. The appropriate use of antimicrobial compounds during processing of raw poultry can help minimize this risk. Currently, peroxyacetic acid (PAA) is the most popular antimicrobial in the poultry industry, displacing chlorine compounds and others. The aim of this review was to compare the effectiveness of PAA to that of other antimicrobials for the decontamination of raw poultry carcasses and parts. Twenty-six articles were found that compared PAA to over 20 different antimicrobials, applied as spray or immersion treatments for different exposure times and concentrations. The most common comparisons were to chlorine compounds (17 articles), to lactic acid (LA) compounds (5 articles) and to cetylpyridinium chloride (CPC, 6 articles). Studies measured effectiveness by reductions in native flora or inoculated bacteria, usually Salmonella or Campylobacter . PAA was found to be more effective than chlorine under most conditions studied. Effectiveness of PAA was higher or comparable to that of LA and CPC depending on product and treatment conditions. Overall, the results of primary literature studies support the popularity of PAA as an effective intervention against pathogenic bacteria during poultry processing.