Tag Archive for: hazard analysis

HACCP vs. Preventive Controls

The world of HACCP (Hazard Analysis and Critical Control Points) versus Preventive Controls is an interesting conversation we are seeing at connectfood.com and across the entire food industry. FDA has trained hundreds of inspectors in Preventive Controls for Human Food and there are thousands of Preventive Controls Qualified Individuals (PCQI’s) across the country and the world. There are tens of thousands of HACCP trained individuals. I have used the analogy that food safety best practices are like a sport; the more you train and the more you focus on “basics done well,” the better your plan will be on a day-to-day basis. The focus is making the food supply safer. This does not mean that HACCP is not valid, as a matter of fact HACCP and Good Manufacturing Practices (GMP’s) should be looked at as the foundation of Preventive Controls for Human Food. Local departments of public health still rely on HACCP as their main line of defense for the food safety industry. We have seen so many small processors and restaurants that have inspections at which HACCP is still the focus, even though Preventive Controls has some more advanced techniques for protection.

Both HACCP and Preventive Controls focus on making sure you have good sanitation practices, employee training and have done a hazard analysis for biological, chemical and physical hazards. I feel like the lines are blurring a bit as companies, academics, and regulators don’t often understand the differences between the two and – to be honest, the differences are not that great from a fundamental level. Here is where I come in with some definitions for you…

    “HACCP: A systematic approach to the identification, evaluation, and control of food safety hazards.

    HACCP Plan: The written document which is based upon the principles of HACCP and which delineates the procedures to be followed.

    HACCP System: The result of the implementation of the HACCP Plan.

    HACCP Team: The group of people who are responsible for developing, implementing and maintaining the HACCP system.

    Hazard: A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.

    Hazard Analysis: The process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan.” FDA.gov

The fundamental principles of HACCP come through in Preventive Controls with some additional areas to focus on as we enhance our food safety plans.

    “In general, you are a covered facility if you are required to register with FDA under section 415 of the Federal Food, Drug, and Cosmetic (FD&C) Act. Covered facilities are required to have and implement a written food safety plan that includes:

Hazard analysis: The first step is hazard identification, which must consider known or reasonably foreseeable biological, chemical, and physical hazards. These hazards could be present because they occur naturally, are unintentionally introduced, or are intentionally introduced for economic gain (if they affect the safety of the food).

If the hazard analysis reveals one or more hazards that require a preventive control, the facility must have and implement written preventive controls for the identified hazards.

Preventive controls: Facilities have the flexibility to tailor preventive controls to address hazards that occur in the products they manufacture. The preventive controls, which must be written, must be implemented to ensure that any hazards requiring a preventive control will be significantly minimized or prevented and help ensure that the food is not adulterated. The rule includes the following preventive controls:

Process controls include procedures that ensure the control parameters are met. Process controls can include operations such as cooking, refrigerating, and acidifying foods. They must include parameters and values (e.g., critical limits), as appropriate to the nature of the applicable control and its role in the facility’s food safety system.

Food allergen controls are written procedures the facility must have and implement to control allergen cross-contact and ensure allergens are appropriately listed on the labels of packaged food products.
Sanitation controls are procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition to minimize or prevent hazards such as environmental pathogens, hazards from employees handling food, and food allergen hazards.

Other Controls are controls that are not described above but are necessary to ensure that a hazard requiring a preventive control will be significantly minimized or prevented.

Oversight and management of preventive controls: Once a facility has identified a preventive control for a hazard, the facility must make sure that the controls are being met.

Monitoring: These procedures are designed to provide assurance that preventive controls are consistently performed. Monitoring is conducted as appropriate to the preventive control. For example, monitoring of a heat process to kill pathogens would include recording temperature values. Monitoring must be documented.

Corrections: These are steps taken, in a timely manner, to identify and correct a minor, isolated problem that occurs during food production.

Corrective actions: These include actions to identify and correct a problem implementing a preventive control, reduce the likelihood the problem will recur, evaluate affected food for safety, and prevent that food from entering commerce if you cannot ensure that the affected food is not adulterated. Corrective actions must be documented with records.

Verification: These activities are required to ensure that preventive controls are consistently implemented and effective in minimizing hazards. Examples of verification activities include scientifically validating process preventive controls to ensure that the control measure is capable of effectively controlling an identified hazard and calibrating (or checking the accuracy of) process monitoring and verification instruments such as thermometers. Verification activities also include reviewing records to ensure that monitoring and corrective actions (if necessary) are being conducted. Verification activities must be documented.

Product testing and environmental monitoring are also possible verification activities, required as appropriate to the food, facility, nature of the preventive control, and the role of that control in the facility’s food safety system. Environmental monitoring is required if the contamination of a ready-to-eat food with an environmental pathogen is a hazard the facility identified as requiring a preventive control.

Supply chain program: Manufacturers must have and implement a risk-based supply chain program if the hazard analysis identifies a hazard that

    (1) requires a preventive control and
    (2) the control will be applied in the facility’s supply chain.

Facilities do not need to have a supply-chain program if they control the hazard in their own facility, or if a subsequent entity (such as another processor) will control the hazard, and the facility follows applicable requirements.

Manufacturers are responsible for ensuring that raw materials and other ingredients requiring a supply-chain-applied control are received only from approved suppliers, or on a temporary basis from unapproved suppliers whose materials are subject to verification activities before being accepted for use. (Suppliers are approved by the facility after the facility considers several factors, such as a hazard analysis of the food, the entity that will be controlling that hazard, and supplier performance.)

Another entity in the supply chain, such as a broker or distributor, can conduct supplier verification activities, but the receiving facility must review and assess that entity’s documentation that they verified the supplier’s control of the hazard.

Recall plan: If the hazard analysis identifies a hazard requiring a preventive control, the facility must have a written recall plan that describes the procedures to perform a recall of the product. The recall plan must include procedures to notify consignees, to notify the public when necessary, to conduct effectiveness checks and to appropriately dispose of recalled product.” FDA.gov

In conclusion, HACCP and Preventive Controls are both food safety risk management systems. connectfood.com provides the ability for all facilities that handle or process food to create a plan depending on what the regulatory authority or a clients needs. Contact us and let us assist you in your food safety planning.

About the Author
Matthew Botos is the CEO and Founder of ConnectFood. ConnectFood offers a step-by-step, “Do-It-Yourself” food safety plan generator to help companies comply with the Food Safety Modernization Act and On-Demand plan reviews from a national network of food experts. Mr. Botos is currently on the Food Safety and Preventive Controls Alliance (FSPCA) International Subcommittee. He is also one of few approved Train the Trainer instructors of the FSPCA Lead Instructor program launched in October 2015 and has taught over 800 of the nation’s leading food safety experts.

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Logs & Record Keeping

In this blog we are going to talk about logs and record keeping. If you seem to continue seeing this topic as a constant theme within the food safety industry, it is because it is the way that all companies have to keep “score” in the food safety world. Documentation is what allows us to benchmark our progress. Records and logs exist so that an organization can tell their food safety story to both regulators and to their customers. Logs are a necessity for your food safety chain, and you can find example forms for logs and record keeping on connectfood.com.

An example of where records are important is if you have a deviation in the food production process. An instance of this would be that your chart recorder ceases to work during a thermal process, say batch heating a product with a pH below 4.1, and at the end of the run you realize that you do not have the chart-recorded log. In this case, other measurements such as handheld temperature monitoring or visual readouts of a redundant thermocouple could be used to showcase that you still have a safe product for the target consumer. You will then use these records and logs to show that you did, in fact, follow your process and that with adequate testing and record review the product would be safe to ship.

    “Implementation records document the actual implementation of the Food Safety Plan. In other words, implementation records demonstrate that you did what you were supposed to do. Examples of implementation records include, where applicable, records that document the actual monitoring of preventive controls, corrective actions taken, different verification activities performed, validation activities performed (if needed), the supply‐chain program checks and applicable training records.” –FSPCA Preventive Controls for Human Food course curriculum.

Records and logs tell a story: from the time a supplier provides an ingredient until the time the product is delivered to the consumer, there is documentation. This story can include a manufacturer asking for the records and logs of how an ingredient was processed to how it was shipped and stored before arriving. This story could follow the documentation of a low moisture ingredient that is shipped at ambient temperature but needs certain humidity controls. Or, it could be an example of fresh fish where the records must show temperature control and amount of time the product has been in transit. These records are all things that an FDA regulator will ask for and that a facility must be able to provide within the 24-hour restriction set by the Food Safety Modernization Act’s Preventive Controls for Human Food rule.

Another area that companies wonder about in regards to record keeping is: how long do I need to keep records, and what if I want to use electronic records?

“Electronic or computerized records are acceptable in a preventive controls system as long as they are equivalent to paper records and electronic signatures are equivalent to traditional handwritten signatures. Controls are necessary to ensure that records are authentic, accurate and protected from unauthorized changes.” – FSPCA Preventive Controls for Human Food course curriculum. ConnectFood talked about the move towards electronic records in a recent online interview with Food Safety News.

When it comes to how long records need to be kept, the answer is a minimum of two years from the date the log or the record was created. The records that relate directly to the food safety plan and the product’s completed food safety plan must be kept on site. Collecting proper records and logs and having them readily available is how companies demonstrate that the food safety plan is working. You can find many of these best practices in the FSPCA manual.

Most important to remember when it comes to records and logs are that, 1. you know what you are monitoring and, 2. you have trained personnel in your facility. All the logs and records in the world will not make a difference if the person tracking and monitoring the records do not know why they are taking these records and how they impact the food safety plan. Having A Preventive Controls Qualified Individual on site that can review and sign off on logs is a critical part of your food safety process. The worst-case scenario is to have a complete plan and a detailed hazard analysis but then have records and logs that do not reflect the accuracy of your production. This can lead to recalls and other issues that jeopardize the company and the consumer.

Your recordkeeping is your product’s story: make sure you’re telling a good one. ConnectFood can help you get your documentation in order and provide you with example sheets for logging. Send us a message.

About the Author

Matthew Botos is the CEO and Founder of ConnectFood. ConnectFood offers a step-by-step, “Do-It-Yourself” food safety plan generator to help companies comply with the Food Safety Modernization Act and On-Demand plan reviews from a national network of food experts. Mr. Botos is currently on the Food Safety and Preventive Controls Alliance (FSPCA) International Subcommittee. He is also one of few approved Train the Trainer instructors of the FSPCA Lead Instructor program launched in October 2015 and has taught over 800 of the nation’s leading food safety experts.

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How do I Add Radiological Hazards into My Food Safety Plan?

Radiological hazards are chemical hazards.
Radioactive chemicals emit harmful radiation that at large doses is harmful soon after exposure and at small doses is harmful years or decades later. Our food may become contaminated through the absorption of radioactive chemicals found in soil or water. Radioactive chemicals in air may settle onto food, water, or soil. Terms used to describe radioactive chemicals include: radioactive isotopes, radioactive elements, and radionuclides. Examples include: radioactive cesium, uranium, and strontium.

You may be familiar with radon testing before purchase of a home; this is standard practice in real estate. I was at the house we were purchasing when the radon test was done – it was a beautiful day, but I could not open the windows or the test would be invalid. Radon is a gas. When a radon test is done inside a house, the air is tested for a given time. (Our house passed the radon test.) Radon is not a chemical hazard of major concern in the food industry.

Radioactive chemicals are naturally present in some rock formations. As rainwater filters through soil and is collected in aquifers below the surface, the water may pick up radioactive chemicals. If your facility uses well water, research the location of the aquifer. What is known about the soil and rock formation surrounding the aquifer? Is the location known to have a risk of radioactive chemicals? If your facility uses municipal water, your water treatment facility tests for radioactive chemicals. Add your annual water report from your water treatment facility to your food safety plan. If you have questions on the report, talk with your local water treatment facility.

When you write your hazard analysis, include radiological hazard as a chemical hazard once for your water supply.
In the hazard analysis you may determine that the hazard does not require a preventive control and will remain as a Good Manufacturing Practice for potable water.

Approve suppliers using your own criteria.
If ingredients for your product include a crop, you may have concerns about the location of the field and water used for irrigation. Theoretically, there could be an uptake of radioactive chemicals if present in the soil or if present in the water used for irrigation. Know the location for the crop and communicate with your supplier if you have any concerns.

Radioactive chemicals are of concern after nuclear power plant accidents. In the 1986 Chernobyl nuclear power plant accident in what is now the Ukraine, plumes of radioactive material were sent into the air in updrafts from a steam explosion and resulting fire. The radioactive material settled into the surrounding area as the wind blew away from the facility. In the 2011 Fukushima nuclear power plant accident in Japan, a tsunami hit the coast. Loss of electricity to cooling pumps caused a reactor meltdown, explosions, and release of radioactive material to the air, ground water, and the Pacific Ocean.

What can you do about the potential for a nuclear power plant accident near you? First, locate the nearest nuclear power plant to your facility. The website for the Nuclear Regulatory Commission has a feature for locating nuclear power plants. Second, determine if you are within an emergency planning zone and review the plume exposure pathway. If your facility is within 50 miles of a nuclear power plant and an accident occurs, there is a ban of contaminated water and food.

When you write your hazard analysis, include radiological hazard as a chemical hazard for your location.
If your facility is within 50 miles of a nuclear power plant, identify a hazard requiring a preventive control and write an emergency plan. Being prepared for an emergency is the best insurance that it won’t happen.

Please comment on this blog post below. I love feedback! Still have questions? The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in prevention of Intentional Adulteration (IA). She has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

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Recall: Lessons Learned – Part 2

In a previous ConnectFood blog, Recalls: Lessons Learned, I wrote about some personal experience working with industry during recalls. I discussed:

  • Are you sure you must initiate a recall?
  • Get yourself a good lawyer.
  • Don’t move that product!

There are two important reasons to have a written recall plan. First, the rule requires it, and, second, the written recall plan will get you organized in the case of an actual recall.

There is a requirement for a written recall plan in the rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food. In Subpart C of the rule, any facility that manufactures, processes, packs, or holds food must complete a written hazard analysis. There are facilities which are exempt from a hazard analysis. Farms are exempt. Facilities earning an average of less than $1,000,000 in revenue are exempt. Food service operations like grocery stores and restaurants are exempt. If a food facility does not perform a hazard analysis, the facility must provide evidence of oversight by a non-federal entity, like a state department of agriculture or a local health department.

It is in the hazard analysis that hazards requiring a preventive control are identified. Right up front in Subpart C we see the Contents of a food safety plan

, and (4) The written recall plan as required by § 117.139(a).

Turning to 21 CFR 117.139(a), we see Recall plan.
For food with a hazard requiring a preventive control:
Does your product potentially have a hazard? Have you identified a hazard requiring a preventive control in the hazard analysis? If you have a ready-to-eat product, you have a hazard, namely an environmental pathogen. If your product has an allergen, you have a hazard. Does your process have metal-on-metal or other physical hazards?

If you have identified a hazard requiring a preventive control in the hazard analysis, you must have a written recall plan as part of your food safety plan.

The recall plan must include written procedures which the company will follow in the event of a recall. Most recalls are announced on Fridays, and then it is all hands-on-deck. The recall plan must name the position of who will do each procedure. You can include names and contact numbers in the recall plan; just remember to keep it updated. Here are some examples. Who is the:

  1. Single person to initiate the recall. Who has the responsibility to pull the trigger on a recall?
  2. Internal recall coordinator. This person may not be a Preventive Controls Qualified Individual.
  3. FDA recall coordinator
  4. State recall coordinator
  5. Accountant. A recall is going to be costly.
  6. Attorney or firm for the recall. Find an attorney who has recall experience.
  7. Contact for communication to the public and press. The public must be notified of the hazard.
  8. Sales personnel who must notify each customer, communicate if the product is to be returned or disposed, and calculate the daily effectiveness check which accounts for how much product has been recovered.

A team of experts must decide the fate of the recalled food. The company will work with the state and/or FDA recall coordinator, attorney, quality assurance personnel, and contract lab. The company may hire a consultant to investigate the cause of the hazard and advise through the recall. If a plan is developed for the food to be reconditioned, reprocessed including relabeling, reworked, diverted, or destroyed, the company will present the plan to the FDA for acceptance.

A mock recall is not required, but highly encouraged.

A mock recall is when the recall team tests and updates the information in the written recall plan. I was reviewing a food safety plan with a client, and we came to the recall plan section. The quality manager informed me that she had just emailed with the FDA recall coordinator during the previous week, when I asked about mock recalls and the testing of the plan. The contact information was on the email signature for the FDA recall coordinator. On a whim, I said let’s call the number. The recorded message told us that the person could no longer be reached!

Since the mock recall is not required, the company will determine the frequency of the mock recall and if the date is announced or surprise. There are advantages and disadvantages both ways. The important concept in a mock recall is to go one step back to the source of an ingredient and one step forward to your customers. For every mock recall you do, take the practice seriously, and you will learn more about your systems and become more organized in your company.

Unfortunately, food recalls are an every-day occurrence in the food industry. Not only is a written plan required by law, but the written recall plan will help your company be organized in the case of an actual recall.

The search for forms and checklists can be overwhelming. The ConnectFood website has free resources. After you sign in for free, you will have access to forms and checklists. The folks at ConnectFood are here to help! Contact us.

Dr. Kathy Knutson has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

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Risk-based Preventive Controls

If you are new to the food manufacturing industry or at least new to food safety, you may not know that the food industry heavily relied on finished product testing to determine safety. It wasn’t until the US manned space program was developed in the 1960s that industry looked at building safety in to the process. Now we look more at farm-to-fork and identify preventive controls outside of processing, as well as within processing. Because of this all-inclusive trip down the food highway, some managers have a difficult time choosing the controls most important to food safety.

One analogy I use is my frightening drive from Green Bay to Chicago one January. I worked until 6:30 pm and left Green Bay in the dark. As I drove out of Green Bay and into the darker countryside, it started to rain. The rain mixed with buckets of snow that alternated between rain and snow for the first hour of my drive. I was in a hurry, driving fast, and actually hydroplaned at least once. As fast as I was going, I was still being passed by semis and other trucks. By the time I reached Milwaukee, the rubber of the driver’s side wiper was flapping around and giving me a marginal view.

In this scenario, what were the most important controls for a safe drive? I stopped in Milwaukee to install a new wiper. My tire tread kept me on the road. The lights were working, as was the engine. I used my seatbelt. The air bags were assumed to be in working condition. The brakes worked. The gasoline is analogous to utilities. My cell phone was charged, if needed as a communication tool.

It was not important how much trunk space I had for my bags. It was not important that the radio worked. Optional features like automatic windows or adjustable mirrors were not important.

Similarly, much of your process is not related to safety. In the hazard analysis for our food safety plans, we are asked to identify hazards and their preventive controls. When you are deciding if a preventive control is needed, imagine taking it away. In my driving scenario, my safety would be compromised without working wipers, lights, tires, engine, seatbelt, air bags, and brakes. These parts of driving received my utmost focus that night. What, if taken away, will compromise safety?

I cannot take credit for the following analogy to define risk vs. severity, but it is a good one. When we are out walking in the world, there is a risk of getting hit and hurt by a car. It is a hazard we all experience. When I leave a building and walk through the parking lot to my car, the probability or severity of getting hit and hurt is small. It hasn’t happened yet! If I do get bumped by car, my injuries might not even be treatable. Now let’s say I walk across an LA highway-six lanes going each way. The risk of getting hit is high, and the injuries will be severe. Think about it; it is the same hazard!

Since I scored high in Harmony on the StrengthsFinder survey, I like my team to be happy and get along. If you have food safety teammates who want to list every hazard in the world in your hazard analysis, keep the peace, and go ahead and list them! Then, your team will debate the risk vs. the severity. By the way, at the end of Chapter 1 in the book for Preventive Controls for Human Food, there is a nice definition for your team of both risk and severity. If loss of control results in a class I recall due to an allergen or pathogen, then the hazard is automatically severe and must have a preventive control. Other hazards, while theoretically possible, may be concluded to be of low risk and low severity. These hazards to not require a preventive control.

As a team:

  • Identify hazards.
  • Define risk vs. severity.
  • Debate and assign risk and severity to each hazard.
  • Identify hazards requiring a preventive control.

The folks at ConnectFood are here to walk across the farm-to-fork path together, hand-in-hand.

Dr. Kathy Knutson has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

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The Language of the Preventive Controls for Human Food Rule

Recently, I sat in a room with 20-some food safety experts eager to learn about the curriculum for the Preventive Controls for Human Food rule. The FDA-recognized curriculum is used as the primary means to call oneself a Preventive Controls Qualified Individual. At the start and at hearing the use of “preventive,” my colleagues and I whipped out our cell phones to look up the existence and meaning of the word. Well, I will tell you it is a word, is chosen for use by FDA, and means the same as “preventative.” Out loud, say to yourself, “preventive measures.” Sounds good, doesn’t it?

Preventive is not the only new word to the rule. The terms of HARPC, still in its infant stage, and its older siblings of HACCP, CCPs, and critical limits are fading into the sunset. If you are a food safety expert who has grown up on the use of HACCP and CCPs, don’t worry. FDA is not making you use the new language. There is still room for use of HACCP and CCPs when identifying process preventive controls. After all, processing is where much of the highest risk in food safety is controlled. Water is removed to prevent growth of mold and production of harmful toxins. Heat is used in pasteurization, canning and baking to kill pathogens. We use metal detectors. The youth in our business will label these process preventive controls, not CCPs. The youth will be studying the rule and the language of the rule.

There are three additional labels of preventive controls-allergen, sanitation, and supply chain. We do not apply the terms of HACCP, CCPs or critical limits to preventive controls in these three areas. Your hazard analysis will identify if you need a preventive control in any of these areas. We identify preventive controls for known or reasonably foreseeable hazards, and set parameters and values. Parameters are just the name of the measurement like temperature, time, belt speed or bed depth. Values are the number and corresponding unit which must be achieved for safety like 185oF, 25 minutes, 1 foot per second, or 2 cm.

Another new kid on the block is the term “correction.” We will still issue corrective action when a food safety issue affects finished product. What about when product has not been affected? The wrong label is moved from storage to the packaging line. Get the right label. A post-sanitation inspection observes areas not cleaned properly. Reclean. A correction allows the righting of a wrong at a preventive control step and before any product is affected.

It takes practice to adopt the new language of the rule. As an educator, I encourage you to say the terms out loud. After some time and in our future, we will hear a colleague say, “What’s HACCP?”

Dr. Kathy Knutson has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

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What is the Food Safety Modernization Act?

In June 2016 I started teaching a workshop with FDA-recognized curriculum. Everyone was there to get a certificate as a Preventive Controls Qualified Individual (PCQI). After a day of training, someone asked, “What is FSMA?” Much to my own surprise I could not succinctly articulate the extent of FSMA nor did the curriculum do a great job of summarizing FSMA. After much research on the FDA and Federal Register websites, I have this summary for you.

FSMA is the federal Food Safety Modernization Act, signed by President Obama in January of 2011. The purpose is to ensure the U.S. food supply is safe by shifting the focus from responding to hazards to preventing them (https://www.fda.gov/Food/GuidanceRegulation/FSMA/). I now understand there are seven foundation rules with FSMA, all under the jurisdiction of the FDA. All seven rules were published from September 2015 to May 2016 with unique compliance dates. Most of you reading this are going to want information on the rule for the manufacture of human food. The preventive controls for human food final rule requires a written food safety plan, record-keeping, a recall plan, and oversight by a PCQI. A future blog will detail the role of a PCQI.

Final rule: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
Who? Human food manufacturers and their ingredient suppliers

When? Initial compliance date of September 2016 for large businesses

FDA actually calls large businesses “other businesses.” That is because the large businesses by definition are not small, very small, qualified facilities, or subject to the Pasteurized Milk Ordinance. All of these have compliance dates beyond September 2016.

Small businesses have a compliance date of September 2017 and are defined as having fewer than 500 employees. Therefore, “other businesses” have more than 500 employees. Very small businesses have a compliance date of September 2018 and are defined as having less than $1,000,000 in annual sales and holdings. By default, very small businesses have fewer than 500 employees. With only $1,000,000 in revenue, that makes sense that the business employs fewer than 500.

Very small businesses are qualified facilities. Having a designation as a qualified facility exempts the facility from the hazard analysis, preventive controls and supply chain requirements. This is a big deal. The business is still required to follow Good Manufacturing Practices, provide attestations in support of their status, provide evidence of oversight and compliance in their location, maintain records, and provide evidence of status annually. Even though a qualified facility is not required to conduct a hazard analysis and identify preventive controls for those hazards, the qualified facility is required to state how they are controlling hazards in their process. In other words, what is the qualified facility doing to make their product safe for the consumer? If a very small business believes they are a qualified facility, their status records must already now be in place.

Businesses subject to the Pasteurized Milk Ordinance (PMO) have a compliance date of September 2018. These grade A milk processors come into compliance after the next revision of the PMO is published. The PMO will include elements of preventive control requirements.

What are the foundation rules of FSMA? Here is a summary of them:

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
This is the animal food rule.
Who? Animal food manufacturers and their ingredient suppliers
When? Initial compliance date of September 2016
In the same way that food for human consumption must be made in a safe manner, the diverting of human food to animal food and the production of animal food must be done safely.

Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
This is the import rule.
Who? Importers of ingredients or food for humans or animals
When? Initial compliance date of May 30, 2017
To see descriptions of who has later dates, go to this FDA document at https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm517545.htm.

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
This is the produce rule.
Who? Raw agricultural commodity farmers
When? Produce growers with more than $500,000 in annual sales must be compliant starting in November 2017. Small businesses with annual sales between $250,000 and $500,000 must be compliant November 2018. Very small businesses with annual sales between $25,000 and $250,000 must be compliant November 2019. Due to high risk, sprout growers must be compliant in November 2016, with small and very small sprout growers compliant in November 2017 and 2018, respectively.
Growers may have modified compliance dates for parts of the rule including water quality standards, testing and recordkeeping; labeling; or retention of records supporting eligibility for a qualified exemption. Many commodities are exempt from parts of the rule due to the nature of the crop.

Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications
This is the audit rule.
Who? Third-party auditors
When? The rule was published November 2015. The Model Accreditation Standards when published will include FDA’s final recommendations on third-party auditor/certification body qualifications and incorporate requirements. Thereafter, auditors will be able to apply for FDA recognition. See the draft guidance for the Model Accreditation Standards at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm455328.htm.

Sanitary Transportation of Human and Animal Food
This is the transportation rule.
Who? Motor carriers, shippers, and receivers of human or animal food
When? Initial compliance date of April 2017
Motor carriers employing fewer than 500 persons and having less than $27.5 million in annual receipts must be compliant in April 2018.

Mitigation Strategies to Protect Food Against Intentional Adulteration
This is the intentional adulteration rule.
Who? Human food manufacturers
When? This being the last of the rules was published in May 2016. The first compliance date is May 2019. Small businesses employing fewer than 500 employees must be compliant in May 2020.
The definition of the very small business is annual sales and holdings less than $10,000,000 and not $1,000,000 as defined in the preventive controls for human foods rule. The very small business must be compliant in May 2021.

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