Tag Archives: Preventive Controls

Audit

Webinar Series: Improve Your Hazard Analysis

By Food Safety Tech Staff
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Audit
Patricia Wester, PA Wester Consulting
Patricia Wester, PA Wester Consulting and Founder, The Association for Food Safety Auditing Professionals

The most commonly cited observation during a Preventive Controls inspection is an incomplete or incorrect hazard analysis, according to FDA data. Food Safety Tech is hosting a special complimentary webinar series, instructed by Patricia Wester, founder of The Association for Food Safety Auditing Professionals, that will provide attendees with important tips on conducting and documenting a thorough hazard analysis. During the one-hour event, Wester will help participants understand how to recognize gaps in a hazard analysis as well as share best practices for closing those gaps. The content is geared toward food safety professionals and auditors who develop, manage or review food safety plans in a Preventive Controls landscape.

What: “Did You Know?” Tips on Improving Your Hazard Analysis
Date: Wednesday, September 18, 2019
Time: 12pm – 1pm ET
Register for the webinar

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Top Tips for PCQI Training Success

By Maria Fontanazza
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In a recent exclusive column on Food Safety Tech, Laura Lombard, CEO of ImEPIK, discusses why food companies should be investing in PCQI training beyond basic FSMA requirements. During the following Q&A, she expands on these insights further to shed light on some of the misunderstandings companies have when it comes to the PCQI requirements under FSMA as well as tips for how to approach PCQI training itself.

Food Safety Tech: What are some of the misconceptions with the FSMA PCQI requirements?

Laura Lombard, IMEPIK
Is Your Facility Properly Prepared to Ensure Preventive Controls Are Met? Read this exclusive column by Laura Lombard.

Laura Lombard: The FSMA rule allows for alternate PCQI training in addition to the original FSPCA training. PCQI trainings are accepted as long as they meet the standardized curriculum recognized by the FDA. The FDA never intended that one organization have a monopoly over PCQI training but equally wants to ensure that core competencies in preventive controls are met.

The FSMA regulation does not require you to have a different PCQI per facility. However, it does require a PCQI to be in charge of an individual food safety plan per location. Depending on how many facilities your particular company has, you may want to consider more than one PCQI to oversee these different food safety plans to ensure that food safety plans are regularly updated and properly implemented.

FST: How should food companies be investing in PCQI training beyond the basic FSMA requirements?

Lombard: It’s very important to have at least one back up PCQI in place to ensure you are always covered if your head PCQI is out sick, on family leave, departs from the company, etc. This isn’t only to meet the FDA requirement of having a PCQI on your team, but also to ensure you are keeping your brand, product, and customers safe. The more you can protect yourself from having to do a recall of your product, the better. Recalls cost an average of $10 million, and this does not including damage to your brand and customer retention.

ImEpik and Food Safety Tech have partnered to offer PCQI online training, with special pricing options for attendees of the 2019 Food Safety Consortium Conference & Expo | Learn moreFST: What are your top tips for companies regarding PCQI training?

Lombard: Be proactive in ensuring your employees are trained. The regulation is the minimum required, but for a small investment, you can ensure more of your food safety staff is current on best practices to ensure your products’ quality and safety.

Look for training that fits your individual or company needs and learning styles. Look for training that is interactive and going to test knowledge rather than just death by PowerPoint. Again, the goal shouldn’t be to check a regulatory box but to ensure that your staff has the knowledge needed to maintain your brands quality, reputation and customer base.

FST: What are some of the differences between the various PCQI trainings on the market?

Lombard: There are three types of trainings that all require 20-hours of content: 1) An in-person version where an instructor leads a 2 or 2.5 day training, 2) a blended-online version that has some content that is self-paced but also requires a set time and date for a webinar portion, and 3) a 100% self-paced online course that does not require a webinar. Some of the blended versions claim to be 100% online. It is true in the sense that both the self-paced content and webinar are computer-based, but it is not as convenient as being able to do the entire training on your schedule. All versions have their pros and cons, but doing the course online can save your company significant time and money by not requiring travel or set timeframes. We have learned that online versions allow learners more opportunity for mastering the material through regular assessments and remediation as needed. It is also an opportunity to practice knowledge through scenarios in a low-risk environment. Lastly, done correctly, online training can be more interactive through the use of games, videos and audio tools to keep learners engaged.

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FSMA Supply Chain IQ Test (Part II)

By Food Safety Tech Staff
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Food Safety Tech’s FSMA Supply Chain IQ test series continues with Part II. The test was put together by the subject matter experts at Kestrel Management, LLC. Before taking Part II, let’s review the results from Part I below. (If you have not taken Part I, take the test now!)

  1.  FSMA requires all records for the reevaluation of cGMPs every three years.
    • FALSE. Only 28% knew this.
  2. Implementation records are required for every FSMA requirement.
    • TRUE. 74% got this right.
  3. Under some circumstances, FSMA requires that conformance of a customer’s control of a hazard is required.
    • TRUE. 90% answered correctly.
  4. Under FSMA cGMPs, you must be able to identify at least 95% all possible contaminated product.
    • FALSE. Respondents were almost evenly split. 51% answered correctly.
  5. Monitoring of frequency of preventive controls must be conducted by the operation as part of the food safety plan.
    • TRUE. 92% answered on target.
  6. Written supply chain plans are not included in FSMA food safety plans.
    • FALSE. 81% answered correctly.
  7. Mandatory recalls are provided under FSMA as a new requirement.
    • TRUE. 63% answered correctly.
  8. Verification effectiveness of the implementation of preventive controls needs to be evident but not documented under FSMA.
    • FALSE. 74% got this right.
  9. cGMPs under FSMA require that outer garments be suitable to protect against allergen contamination.
    • TRUE. 77% answered correctly.
  10. You do not need to document records of all product testing under FSMA.
    • FALSE. 82% answered correctly.
  11. FSMA preventive controls does not require hazards be addressed under the HACCP plan.
    • FALSE. 69% got this right.
  12. The food safety plan does not require hazards that are unintentionally introduced within an operation’s processes.
    • FALSE. 82% answered correctly.

Surprised by the results? Provide feedback in the comments section.

We invite you to take Part II below and then learn more about important supply chain issues at our Food Safety Supply Chain Conference, May 29–30. You can attend in person or virtually.

Create your own user feedback survey

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FSMA Supply Chain IQ Test (Part I)

By Food Safety Tech Staff
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Food Safety Tech’s FSMA IQ test series continues with a two-part series that addresses supply chain considerations under FSMA. Once again, the test was put together by the subject matter experts at Kestrel Management, LLC. We invite you to take the 12-question test and then learn more about important supply chain issues at our Food Safety Supply Chain Conference, May 29–30. You can attend in person or virtually.

Results of Part I will be posted next week, at which point Part II will be available.

Create your own user feedback survey

Melody Ge, Kestrel Management
FST Soapbox

Still Have Questions about FSMA Preventive Controls?

By Melody Ge
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Melody Ge, Kestrel Management

In September 2015, the FSMA Preventive Controls for Human Food Rule was published, requiring affected companies to comply with all FDA timelines. The last of these deadlines required that all very small businesses (less than $1 million per year) be in compliance with the FSMA rule by September 17, 2018.

With most companies having implemented FSMA preventive controls at this point, what have we learned? What’s still not clear? What major challenges remain? This article shares some questions that could help more companies on their journey to FSMA compliance.

What Is the Preventive Controls (PC) for Human Food Rule?

In plain language, under FSMA’s preventive controls for human food, FDA asks companies to identify any known and foreseeable potential hazards to finished products, and then apply control measures to prevent those hazards from happening and to ensure companies produce safe products. This rule changes the mentality from reactive to proactive.

Let’s break the term preventive control apart:

  1. What are we preventing? We are preventing any potential hazards that could occur. FDA identified four major categories of hazards. Food companies must look at their production processes and identify any foreseeable hazards within these categories:
    • Physical
    • Chemical
    • Biological
    • Intentional adulteration for economic gain
  2. What are we controlling? We are controlling the risks from all those hazards identified. Control measures should be identified for each risk from a particular hazard identified so they can be effectively applied.

Melody Ge will close out the 2018 Food Safety Consortium with the Plenary Session, “What Have We Learned After FSMA Implementation?” | November 15Where Do We Start?

A logical starting point involves understanding all hazards at your production facility. How can you ensure all hazards are assessed and evaluated? Consider mapping out the process line as one effective way. It is important to thoroughly understand your processes, as well as all raw materials, equipment, and personnel associated with each processing step. The more details gathered at the beginning, the easier it is to understand the hazards and risks as a foundation. A hazard can always be eliminated later if it is not applicable nor likely to occur.

Are All Control Measure or PRPs Considered Preventive Controls?

The short answer is not necessarily. Only those associated with a potential hazard will be considered a preventive control. For example, for an approved supplier program controlling incoming goods and suppliers, if an allergen is identified as a potential foreseeable hazard, the approved supplier program at the receiving step will be identified as a preventive control. Once a preventive control is determined, it must be evaluated to ensure it is proper and applicable to control and minimize the risks (117.420).

The same mentality should be applied for other control measures. Is there is a hazard and, if so, can this control measure actually control the risk? Once preventive controls are determined and identified, monitoring and validation are the next steps to ensure preventive controls are functioning effectively to control the risks as expected. If not, proper corrective actions should be identified.

Are Corrective Actions Always Required?

Not always—it depends! It is important to remember the intent of FSMA’s preventive controls, which is to prevent any potential hazards and control the risks to ensure safe products are produced. Per 117. 150, corrective action is a must when:

  • There is a potential pathogen threat in RTE products
  • There is a potential pathogen threat from the environmental monitoring program
  • A preventive control is not properly implemented and a corrective action procedure has not been established
  • A preventive control(s) or the food safety plan as a whole is not effective
  • Records are not completed after review

Other than the above-mentioned, corrections can be applied to address minor and isolated problems in a timely manner. As with all other food safety management systems (FSMS), once a corrective action is determined and implemented, a verification of its effectiveness shall be conducted. In addition, everything should be documented, as records are a vital component of the preventive control rule.

The FSMA Preventive Controls Rule is not scary. It is simply a series of requirements to assist the industry in proactively identifying the best control measure for operations. Foreseeable hazards must be controlled. As with all other management systems, knowledgeable and experienced personnel can help develop a valid food safety plan, including preventive controls, and ensure it is effectively implemented and maintained onsite.

FSMA Preventive Controls Corrective Action Requirements

FDA

FDA Issues Guidance Document for Qualified Facilities Under FSMA Rules

By Food Safety Tech Staff
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FDA

Last week FDA released a guidance document to help facilities understand whether they are subject to the “qualified facility” definition under the FSMA preventive controls rules for human and animal food. Titled “Determination of Status as a Qualified Facility”, the guidance offers frequently asked questions about the requirements for facilities that manufacture, process, pack or hold human as well as animal food (defined separately—Part 117 for human food and Part 507 for animal food).

“Under each rule, qualified facilities are exempt from the hazard analysis and risk-based preventive controls requirements, and instead are subject to modified requirements. These requirements include the submission of a form to attest to the facility’s status as a qualified facility, and attest that it is controlling potential hazards associated with its food or complying with applicable non-federal food safety laws and regulations.” – FDA

Facilities that fall under the PC Human Food rule must submit the first required attestation forms by December 17, 2018, and those subject to the PC Animal Food role must submit the first required attestation forms by December 16, 2019.

More information about the new guidance for industry is available on FDA’s website.

Chelle Hartzer, Orkin
Bug Bytes

Don’t Let Pests Wreck Your Supply Chain

By Chelle Hartzer
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Chelle Hartzer, Orkin

In today’s global marketplace, it has become necessary for facility managers to implement more detailed inspection and documentation policies for incoming shipments as part of the larger food safety plan. But plan as you might, pests are adept at infiltrating food products and contaminating shipments. Their resilience and persistence will make you pay, literally, if you’re not paying close attention.

Pest management is a key component of any facility manager’s food safety plan, but understanding how best to prevent pests from compromising shipments—and by extension the supply chain—takes diligence. An integrated pest management (IPM) program is the best way to ensure that insects and rodents are kept away from processing, packaging and storing food products. Again, this information shouldn’t be anything new if you’re a food processing facility manager, but it’s important to note that IPM focuses on proactive prevention of pests, to align with FSMA’s Hazard Analysis and Risk-Based Preventive Control (HARPC) regulations. These newer regulations shift the focus from reacting to potential contamination concerns to preventing as many issues as possible. Being proactive is a must.

Aside from the legal backlash a facility could face if found if violating these rules, pest issues can also have a major negative impact on a business’ bottom line. Imagine the cost of even one of your outgoing shipments being contaminated by cockroaches or stored product pests. Now, imagine the impact on your business from consumer backlash if the pest-ridden shipment travels further down the line. Simply put, it’s never good if the pest problems are traced back to your facility.

So, what’s the best way to protect your supply chain from potential pest issues and remain compliant under FSMA and HARPC?

All food safety plans should have considerations in place based on a review from a Preventive Controls Qualified Individual (PCQI). This individual is responsible for preparing the document, with the input of as many departments and people as possible, such as QA/QC, maintenance, production teams, and more. Since pests are a common potential hazard, a pest management program should be included in the plan.

That being said, it’s important to inspect all incoming shipments. Even if suppliers have implemented measures to help keep pests away from their sites and products, pests are tough to entirely prevent and it’s always a possibility some have slipped through the cracks (literally!). Pests are attracted by food, water and shelter, so a truck transporting products to your facility is going to be chock-full of attractants! Carefully inspecting incoming shipments will not only help ensure pests don’t enter your facility, but it will help you and your supply chain partners target exactly where problems may be occurring. Forming good relationships with your suppliers, and keeping communication open can help to manage any issues that may pop up.

The faster pest issues are detected, the better. It’s easier to address a pest problem and more accurately pinpoint where it originated if it can be caught early. Otherwise, pests can reproduce quickly and spread, making it harder to pin down the source of an infestation and to treat it. It’s tough to overstate the importance of open lines of communicated between supply chain partners!

To avoid allowing pests into your facility or sending them to a supply chain partner, implement the following processes:

  • Inspect shipments for pest activity, especially incoming shipments. Some common signs include live or dead insects, droppings and damage to the product and packaging.
  • Ensure packaged products are properly sealed and undamaged before transport, and then check the transportation vehicle before loading product for shipping.
  • If there is a pest sighting, remove any compromised product to avoid allowing pests to spread to other goods or find a way into the facility. If it can’t be removed from the facility, isolate it in a contained area and call your pest management provider immediately.
  • Empower employees to call out pest issues as well by implementing a “see something, say something” policy. Don’t forget to have a pest sighting log, and let the employees know where it is and what to record.
  • Use monitoring devices to detect pest activity levels. Devices like insect light traps, pheromone monitors, and glue boards can be easily placed in shipping and receiving areas as an early warning sign of pest activity.

With an untrained eye, pest issues can be difficult to notice. Ask your pest control professional about a free training session for employees. Most pest management companies offer this service free of charge, and it can be a big help. There’s no reason you shouldn’t take advantage.

The pest pressure a facility faces is dependent on a variety of factors including location, geography and the type of product being produced and stored. No two facilities are the same, which is why every pest management program should be customized to meet the needs of the business.

As a start, the following pests are the most common to find in the food processing industry.

  • Rodents: Rats and mice can carry disease-causing pathogens that can be deposited onto other surfaces by simply making contact with equipment or products. Both are capable of fitting through tiny gaps (mice can fit through a hole the size of a dime, while rats can fit through a hole the size of a quarter), meaning any openings on the exterior of a building serve as a welcome mat to a curious rodent. To spot the signs of rodent activity, look for droppings and yellowish-brown grease marks around corners and along baseboards, as these marks can be caused as a rodent rubs against these areas. In addition, look for gnaw marks around any gaps or openings in walls and on products.
  • Cockroaches: Able to squeeze their bodies through miniscule gaps, cockroaches will feed on just about anything. With a good food source, they can reproduce quickly. A couple cockroaches can become an infestation in a matter of months, especially with an abundant food supply. Cockroaches are most active at night, so if you see one during the day it’s a good sign that it’s time to act quickly!
  • Flies: While less likely to find their way into packaged products, flies can spread dangerous, potentially disease-spreading pathogens on everything they touch. They usually don’t travel too far from their larval food source, but their ability to reproduce quickly can make them a nightmare to get rid of if steps aren’t taken to remove them immediately.
  • Stored Product Pests: There are numerous kinds of stored product pests, but all are adept at thriving in and around products undetected. The Indian meal moth, for example, is a moth with small, cream colored larvae that will eat just about anything. Stored product pests are some of the most likely pests you’ll find on incoming shipments and in storage areas, as they’re right at home breaking into and surviving within product packaging.

Keep these pests on the radar, and make sure to take note of where pests are found and how many are spotted. The more information, the better, as it helps pest management professionals get to the root of pest problems.

Documentation is always a major key. It shows an auditor that careful planning and proactive prevention are points of emphasis, which will be important. Although there are numerous documents to keep on hand, add the following to your list in order to more easily demonstrate compliance with pest related FSMA regulations:

  1. Supply chain program, including suppliers and ingredients.
  2. Receiving procedures, including the pest management program that helps prevent pests from entering the facility on products or through loading areas.
  3. Receiving records, or, in other words, documentation of shipments received from suppliers.
  4. Monitoring records of any captured pests in or around the facility and any corrective actions.
  5. Application records for treatments used in and around the facility.

If suppliers are located in another country, note the requirements differ from facilities located in the United States. The FDA breaks this down on their website, but importing products from another country means a facility must follow the Foreign Supplier Verification Program. This comes with a different set of compliance documents and means the importing facility must monitor foreign suppliers’ food safety plans.

Remember: Preventing pests needs to be a proactive process included in the food safety plan. If you want your supply chain to remain pest free, partner with a pest management company and talk to your supply partners to establish standards for documentation and communication. All will benefit, as you’ll be able to catch problems early and have a better chance of keeping pests from wrecking your supply chain.

Read on for more articles by Chelle Hartzer.

How to Prepare for an Audit at Any Time

Minimize the Risk of Pests by Maximizing Your Staff

 

Melody Ge, Kestrel Management
FST Soapbox

8 Tips to Food Safety Program Development for Small and Entrepreneurial Businesses

By Melody Ge
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Melody Ge, Kestrel Management

The FSMA HARPC regulation has been in the implementation phase for approximately a year. Many small and entrepreneurial businesses are in the process of starting or finalizing the development of a food safety plan to comply with FSMA requirements. This includes program development, operational awareness and employee training. Often, small companies find this development more challenging compared to mature companies for several reasons, including a lack of resources or simply not knowing where to start.

The following eight tips can help small businesses that are developing a food safety plan to comply with FSMA.

1. Don’t be scared.

FSMA Preventive Controls is nothing scary. It is simply a series of food safety protocols and related documentation. It might seem overwhelming at the beginning with many documents and changes; however, it is actually a good method and tool to help strengthen operation lines and management.

FSMA helps businesses sustain and streamline processes. It is helpful to first map out the production process from the very beginning (when raw materials are received) through the end (when finished products leave the facility). The more details that are documented on the process, the easier and less time consuming it will be later to prevent potential risks.

2. Be familiar with the process and the FDA hazard types.

Once all processes are mapped, take time to study and get familiar with them. It will be helpful to have a team of individuals with different job functions review process maps together. The objectives are to identify the following:

  • Where is the weakness?
  • Where can weaknesses be controlled?
  • What should be monitored?
  • When is a good time to monitor each process step?

According to FDA, five hazard types need to be considered and prevented: Physical, chemical, biological, intentional adulteration and radiological. These five types should always be kept in mind when reviewing and analyzing the direct production and non-direct production processes.

3. Thoroughly understand the entire supply chain.

Supply chain management is one of the key preventive controls required by FSMA. Just like mapping out the process, FDA requires each business to have a thorough understanding and control of its supply chain to ensure the risks are minimized from raw materials to end consumers. Whether you have foreign suppliers, distribution centers or co-manufacturers, finished product safety must not be compromised by any party. If foreign suppliers are being used, FSVP (Foreign Supplier Verification Program) must be implemented and communicated to vendors.

4. Think in food safety mindset.

If your business has just been established, then congratulations! You have the opportunity to start everything right from the beginning. Take food safety into consideration throughout every step in the process and operation. Considering food safety aspects and preventing hazard types might help you make your next good business decision.

5. Get everyone involved!

Food safety is not only the food safety and quality departments’ responsibilities; it reflects the entire company’s operational structure—from building structure, security, production line, and supply chain to procurement, HR and finance. Get everyone involved, from top management to line workers. Their expertise, experiences and feedback will help the entire program’s implementation and execution. With the inputs from each department function, the food safety program will be more practical to the entire business operation and, therefore, will be more solid and sustained, especially when it comes to ongoing implementation.

6. Designate one project leader.

If FSMA program development is considered a project that the whole company engages in, a project leader is required to make the journey efficient and smooth. The leader needs to have both the company operational experience, as well as food safety knowledge. The leader plays an important role in leading the project, coordinating the timeline, prioritizing work across departments, and communicating with all levels of employees.

7. Keep everything documented and recorded.

Documentation and recordkeeping are core to the entire program. Say what you do by writing down all procedures, policies, programs and SOPs. Do what you say by demonstrating what is contained in all records kept onsite. This is not only for audit purposes, but also for your own business growth. Your own operation data is the best data to improve and modify your processes, if needed. Records can be used for trend study and analysis after years in business. Records can reveal whether methods or programs implemented are working effectively and helping the business. Records can also provide strong support/evidence when there is an unexpected event.

8. Utilize free third-party resources.

There are many technologies linking the entire world together—leverage them to learn from your peers. GFSI-recognized certification programs, such as SQF, FSSC22000 and IFS, are releasing a global market program to specifically help small business start their programs. Webinars and trainings are available on many program development and food safety hot topics to help address challenges, and there are many tools and templates available for download to assist with documentation and recordkeeping.

Although there are a lot of perspectives and aspects to be considered to comply with FSMA, compliance can be achieved one step at a time. Start by mapping out your own production process today.

FSMA

FDA Issues Draft Guidance on Supply Chain Program for PC Animal Food

By Food Safety Tech Staff
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FSMA

Under the FSMA Preventive Controls Animal Food rule, certain animal food manufacturers that receive raw materials and ingredients must develop and implement a risk-based supply chain program. This is required if the facility determines that a supply-chain-applied control is the appropriate preventive control for a hazard of an incoming ingredient. In order to better help animal food facilities meet these requirements, the FDA released a draft guidance, “Guidance for Industry #246: Hazard Analysis and Risk-Based Preventive Controls for Foods for Animals: Supply-Chain Program”.

According to an agency news release, the draft guidance will help facilities in the following areas:

  • “Determine whether they need a supply-chain program;
  • Identify and implement the appropriate supply-chain program activities required to approve their suppliers and verify their supplier is controlling the hazard in raw materials or other ingredients;
  • Establish frequency of supplier verification activities;
  • Meet documentation and recordkeeping requirements; and
  • Recognize situations that necessitate or allow for flexibility or different supplier verification activities.”

In addition, the document offers clarification for receiving facilities that are animal food importers and subject to the supply-chain program requirements of the FSVP rule.

The FDA is accepting public comments on the draft for the next 180 days.

Omar A. Oyarzabal, Ph.D.

Unraveling the Impact of FSMA On Acidified Food Regulations

By Omar A. Oyarzabal, Ph.D.
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Omar A. Oyarzabal, Ph.D.

The world of acidified foods is complicated—the question of how an acidified food is distinguished from an acid food, how to measure pH of acidified foods that are not homogeneous, what kinds and how records should be maintained and finally, how FDA enforces requirements? As consultants to FDA regulated industries, we receive numerous questions, as does FDA directly, on acid and acidified foods. This Q&A, answered by EAS Independent Consultant, Omar Oyarzabal offers insight into commonly received questions and their answers.

Q: How you distinguish an acid food from an acidified food?

Omar Oyarzabal: Acid ingredients have a natural pH of 4.6 or below, while low acid ingredients have a natural pH above 4.6. Acidified foods are comprised of low acid ingredients mixed with acid ingredient or acid to bring the finished product equilibrium pH to less than 4.6. Remember, all pH meters have a normal variation in the measurements, and therefore that variation must be understood and accounted for when measuring the equilibrium pH. For instance, if you measure a pH of 4.3, and may have a ± 0.02, the actual pH is between 4.28 and 4.32. If the variation is ± 0.05, the actual pH may be between 4.35 and 4.25. We would like to see some room for safety and therefore the highest target equilibrium pH is, in many cases, 4.4. The finished equilibrium pH is the pH of all components of the product. It can happen quickly after mixing and final preparation, or it may take hours or days.

Note: pH meters perform potentiometric measurements, meaning that the electrode measures a potential of [H+] or [OH-] in the test solution by comparison against known [H+] or [OH-] standard buffers. The numerical numbers produced by a pH meter are calculated following a scale. Therefore, we need to verify that the calculated pH scale is reliable by proper and regular calibrations.

Total Cases Reported for Previous Years
Botulism Cum 2017 Five-year weekly average  2016  2015  2014  2013  2012
Total 79  4  201 195 161 152 168
Foodborne 5  0  31 37 15 4 27
Infant 71  3  144 138 127 136 123
Other (wound and unspecified) 3  0  26 20 19 12 18
Table I. The main biological hazard of concern in acidified foods continues to be Clostridium botulinum. The latest Notifiable Diseases and Mortality Table was released by the CDC on January 5, 2018. Cases of botulism reported in the United States (Week ending December 23, 2017).

Q: Is there a formal procedure for assessing initial/raw pH? Specifically, should pH be immediately measured or should the system be given time to come to equilibrium?

Oyarzabal: There are two important pH measurements, the raw pH and the equilibrium pH. The raw pH is the pH of all the low acid food ingredients without the addition of the acid ingredients or acid to bring the finished product equilibrium pH to below 4.6. The equilibrium pH is tested in finished product after the pH has “equilibrated” and all particles and components of the finished product have the same pH. It is customary to measure the equilibrium pH after 24 hours of manufacturing, but the actual time depends on the products. If the product has particles with high buffer capacity, the product may take more than 24 hours to achieve an equilibrium pH. The shift from raw pH to equilibrium pH is called the “pH shift”.

Q: What is the basis for the 10% rule for non-acid ingredients, and is it acceptable to have more than 10% but still have acceptable shift in pH?

Oyarzabal: There is no regulation requiring less than 10%. It is a rule of thumb based on experience that has been used for some acidified products over the years. It is not part of any regulation per-se. The actual amount of acidification in a formulation is something for a process authority to evaluate and make a final recommendation.

Q: A challenge study is generally requested for an acidified food filing, however, the detail for the challenge study is not specified. Previously the three main pathogens were suggested for evaluation (pathogenic E. coli O157:H7, Salmonella and Listeria monocytogenes) and a 5-log reduction as criteria. What are current requirements?

Oyarzabal: A challenge study may be needed when developing a new product. But the microorganism of public health concern and/or spoilage concern will depend on the type of product (ingredient formulation) and process. New product should be treated on a cases-by-case basis and a processing authority should make recommendations.

Q: What is the focus of the FDA inspections of acidified foods? What are the agency recommendations for processors?

Oyarzabal: FDA has stated in the Preamble to the final Preventive Controls for Human Foods (PCHF) regulation that acidified foods would not be exempt from 21 CFR 117, Subparts C (specific preventive control requirements) and G (supplier management). Essentially, an acidified food manufacturer, during an FDA inspection, will be have to demonstrate compliance with both 21 CFR 114 (acified foods) and 21 CFR 117 (all foods). During any given FDA inspection, the FDA investigator may focus their attention on just part of the acidified food operation and the applicable regulations or on the entire acidified food operations and all applicable regulations. It is dependent upon the individual FDA investigator, the circumstances triggering the investigation, any recent illness outbreaks or deaths associated with a similar acidified foods, written FDA headquarters programs on acidified foods, etc.

Q: Is a continuous recording method required to prove compliance in meeting Critical Control Points at all times or is periodic manual check acceptable?

Oyarzabal: From a preventive controls perspective, there is no requirement for continuous monitoring. Monitoring has to be performed frequently enough to make sure there is “demonstrated” control of the hazard(s) addressed at that process or step. It may come down to what equipment is in place. But at the end of the day, the preventive control regulation provides flexibility for frequency, so long as it is appropriate to control the identified hazard. If a firm has justification that monitoring at a certain frequency is sufficient to control a hazard, it would be helpful to provide that justification if the issue came up during an inspection. Justification should be emphasized for the frequency of monitoring and verification, and must be robust enough to guarantee safety.

Q: Are salad dressings exempt from the acidified food regulations? What about cold brew coffee?

Oyarzabal: Most salad dressings may be exempt, but it would be wise for any salad dressing manufacturer to ensure that they are using a processing authority with expertise in the type of product to conduct a food safety evaluation and put their recommendations in writing, just in case there is a challenge by FDA, a customer or competitor.

All the cold brew coffees we are aware of are sold under refrigeration and therefore are exempt from low acid or acidified food product regulations.

Note: Most states have individuals that will help the industry identify the laws covering their products. The FDA also has a portal for submission of industry request related to food safety regulations that may apply to specific products.

Q: I want to produce a cold-fill beverage that will have preservatives in the recipe, do I still require a process authority to create a process schedule?

Oyarzabal: You need to have someone to review the product formulation and the process to see if it is a low-acid or acidified food, and determine the food safety regulation under which the product falls. It may be exempt from some regulations, but someone with the appropriate knowledge, such as an FDA recognized “Process Authority”, needs to make that determination. The FDA also has a portal for submission of industry questions related to food safety regulations that may provide a more direct answer to this question.

Q: What are FDA’s expectations on cold-filled acidified foods? Do we need to hold the products till the product formulation ensures 5-log reduction of relevant pathogens?

Oyarzabal: This is a product-related question and without the full understanding of the formulation and process, it is hard to provide any recommendation. The cold-filled process can be managed for acidified foods in a manner that would maintain the safety of the food and not impact the pH requirements or result in recontamination.

Q: Does FDA consider “water” ingredient as a “low-acid” ingredient? What about under the FSMA Rule?

Oyarzabal: Yes, traditionally water has been considered a low acid ingredient as it has the ability to modify the pH of the food. In some recipes water is added in such a low amount that it doesn’t change the rest of the formulation. The addition of water in those cases doesn’t change the rest.

Q: Are inspectors using the Acidified Guidance Document that was pulled a couple of years ago for inspections?

Oyarzabal: The 2010 draft received lots of comments, and ultimately was never finalized from draft form. Investigators inspecting acidified foods are aware of the 2010 guidance, but they should not be enforcing the provisions in this draft guidance. A guidance document is not binding on FDA or industry, but provides recommendations to consider as it contains the agency’s thinking at a given time in relation to a given piece of regulation. That being said, based on observations and comments from the acidified food manufacturing industry, FDA investigators are using the draft guidance as a reference source.

Q: Are electronic records permitted for process controls (e.g., electronic record of temperature instead of chart recorders)?

Oyarzabal: Yes. The Preventive Controls rule speaks to the acceptability, in theory, of electronic records, though, as stated in 117.305(g) they are not required comply with 21 CFR 11 (Electronic Records; Electronic Signatures). These along with any other records should be accessible and retrievable as appropriate in a reasonable time frame for review by an FDA investigatory.