Tag Archives: food safety

How is HARPC Different From HACCP?

HACCP and HARPC share more than just four letters. They’re both food safety standards based on prevention, but they do differ on execution. Their differences and their similarities aren’t as important as the way they fit together for most food processors, though. A HARPC plan shouldn’t be considered as a replacement, but as a necessary upgrade to the conventional HACCP plan. Understanding how the systems fit together is the first step toward implementing both.

HACCP HARPC
(1) Is the preventative approach based on a standard, guideline or a set of laws?
Based on a guideline recommended by CODEX and NACMCF Based on FSMA act and principally, the Final Rule for Preventive Controls for Human Food
(2) What food safety risks are considered using the preventative approach?
Conventional – Biological, Chemical, and Physical Beyond the conventional risks for actual and potential food safety hazards
(3) What is the goal of the preventative approach?
To prevent, eliminate (or) reduce hazards to a safe level (in that priority) Preventive controls that prevent or significantly minimize “known or reasonably foreseeable” risks
(4) Who is primarily responsible for the development and maintenance of the preventive plan?
Primarily, a competent HACCP coordinator with assistance from multidisciplinary team Trained Preventive Controls Qualified Individual (PCQI) as described in the FSMA Act
(5) At what frequency is the preventive plan being reviewed by the facility?
At least once a year, or when required At least once in 3 years, or when required
(6) The plan is mandatory for what type of establishments?
For FDA and USDA mandated establishments, or when required for certification purposes For all establishments along the food supply chain that serve U.S. consumers, unless exempted
(7) The plan is excluded or exempted for what type of establishments?
Unless mandated or required for certification, HACCP is voluntary, and GMPs are mandatory Exemption list is provided by FDA, but this does not exempt facilities from following at least CGMPs
(8) Who is the interested party here? For whom is the plan for?
Stakeholders: auditors, inspectors, and customers The FDA
(9) What is the documented approach for making the preventive plan?
12 Steps of HACCP (includes 7 Principles) 7 Steps of Developing a HARPC Plan

HARPC as an Upgrade to HACCP

HACCP, or Hazard Analysis Critical Control Points, is already widely used due to requirements from retailers, auditing standards, and inspectors, though the USDA and the FDA only mandate it for meat, seafood, and juice products. As a global standard conceptualized the 1960s, HACCP has been continually developed and updated. HACCP requires a multi-disciplinary team for implementation and follows prescriptive steps.

HARPC covers food safety concerns beyond Critical Control Points and is mandated by the FDA for most facilities, with some exemptions. Instead of only looking at process steps where controls can be applied (as in HACCP plans), HARPC relies on the applicable FDA regulations, standards, and guidance documents to develop a Preventive Controls Plan.

How HACCP Works

HACCP is a globally recognized risk-based preventative approach recommended by the Codex Alimentarius Commission (or the ‘Food Code’) and the National Advisory Committee on Microbiological Criteria for Foods. It commonly focuses on controlling the three main food safety hazards: biological, chemical, and physical. The primary goals (in order of priority) are to prevent occurrences of the hazard, or eliminate, or reduce the food safety hazard to acceptable or safe levels.

 The HACCP plans are developed, implemented, and maintained by a multi-disciplinary team and the entire process is facilitated by a HACCP Coordinator, a person who is sufficiently knowledgeable and skilled in food safety concepts and principles and has undertaken a training program that has preferably been accredited by the International HACCP Alliance. The responsible person must review the HACCP plan at least annually, or whenever there are significant changes in food safety design layout, processes, product composition, or technology.

 The HACCP program is legally mandated for meat and poultry establishments (under USDA jurisdiction) and juice and seafood processing establishments (under FDA’s jurisdiction). Even though the HACCP program for several food establishments may be voluntary (unless specified by regulations, industrial standards, or by customers), it does not absolve a facility from implementing Current Good Manufacturing Practices (as provided in the 21 CFR 110 legal document) and other relevant pre-requisite program requirements necessary to maintain the safety and legality of the food products. In the Food Code, prior to HACCP recommendation, there are General Principles of Food Hygiene (provided in 10 sections) that have to be followed. Auditors, inspectors, customers, and other stakeholders may inspect the HACCP or food safety plan.

12 Steps of HACCP:

  • Assemble the multidisciplinary HACCP team
  • Describe the product
  • Identify its intended use
  • Construct a flow diagram
  • Conduct on-site confirmation of the flow diagram, and draw up the plant schematic
  • List all potential hazards associated with each step, conduct a hazard analysis, and consider any measures to control identified hazards (Principle 1)
  • Determine Critical Control Limits (Principle 2)
  • Establish Critical Limits for each CCP (Principle 3)
  • Establish a monitoring system for each CCP (Principle 4)
  • Establish corrective actions (Principle 5)
  • Establish verification procedures (Principle 6)
  • Establish documentation and record-keeping (Principle 7)

How HARPC Works

In brief, this preventive control system mandated by FDA’s FSMA Act is to be implemented by all food establishments unless specifically exempted. Thus, it applies to food facilities in the U.S. that manufacture, process, pack, distribute, receive, hold, or import food, and for those firms exporting foodstuff to the US. The FDA has issued implementation deadlines for each of the different facility types (kindly refer to updated guidelines on the FDA site, www.fda.gov). Within a HARPC plan, the food safety hazards assessment is broader; generally, the following risks are considered:

  • Biological, physical, chemical, and radiological hazards
  • Natural toxins, pesticides, drug residues, decomposed material, parasites, allergens, and unapproved food and color additives
  • Naturally occurring hazards
  • Unintentionally introduced hazards
  • Intentionally introduced hazards, including acts of terrorism

Preventive controls are science-based and shall be adequate to significantly minimize or prevent identified hazards “known or reasonably foreseeable” for each type of food subject to the relevant FDA regulation. The HARPC plan is developed, implemented, and maintained by a team of “preventive controls qualified individuals” as defined in the FSMA act, who have been trained or are sufficiently conversant with the FDA FSMA Final Rule for Preventive Controls for Human Food, and any other relevant rulemakings, such as the Final Rules on Animal Food, Produce Safety or Foreign Supplier Verification Program etc. (for more information, refer to the FDA site, www.fda.gov).  The responsible person must review the HARPC plan at least once every 3 years (if no significant changes occur in the plan) or whenever there is a significant change at the facility that might increase a known hazard or introduce a new one.

7 Steps of HARPC

  1. Assess the hazards—This includes the normal product-specific hazards, along with a broad range of other hazards (listed above) and facility-specific concerns such as food defense and emergency management issues.
  2. Institute Preventive Controls—These include sanitation procedures for food contact points, staff hygiene training, environment monitoring, supplier verification, and more.
  3. Monitor effectiveness of the controls—Not all controls are measurable by critical limit numbers, but these Preventive Controls can be evaluated on a routine basis.
  4. Establish corrective action measures—Recall plans may not seem preventive, but the critical steps between knowing something is wrong with a product and keeping it away from consumers’ hands should involve identifying and correcting the weak spots within the controls. The objective is to prevent occurrences of unsafe and non-conforming food product.
  5. Establish verification measures—The process of verification ensures that the facility is effectively meeting its food safety standards on a consistent basis.
  6. Follow proper and required recordkeeping—As with any FDA ruling, nothing is properly done until it’s recorded.
  7. Reanalyze the plan once every 3 years, or when needed—When changes in process or product happen, HARPC plans should be reevaluated.

Recap of Some Key Differences:

Hazard Analysis Method

The three conventional types of hazards that are addressed in the HACCP plans—physical, chemical, and biological—are accompanied by many more concerns in HARPC plans.

Radiation, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, unapproved food or color additives, naturally occurring hazards, and intentionally and unintentionally introduced hazards round out the list of HARPC-related hazards.

Critical Control Points Versus Preventive Controls

Critical Control Points during process steps are central to HACCP. Each control point must include measurable critical limits—the temperature and length of time a sauce must be held at, for example, as a kill step. The objective of each control step is either to prevent, eliminate, or reduce food safety hazards to a safe and acceptable level. Food safety measures that aren’t specific to the process, such as personnel hygiene, are covered under Standard Operating Procedures (SOPs).

HARPC focuses on Preventive Controls that are science- or risk-based, and should be adequate to “significantly minimize or prevent” known or foreseeable hazards for each type of food subject to the federal regulations.

 

To learn more about HACCP, download our whitepaper, “HACCP Planning for Food Safety,” or contact our knowledgeable customer service representatives at cs@remcoproducts.com or at 317.876.9856. Contact us today to schedule a complementary on-site consultation regarding HACCP and HARPC plans.

To view more information about this and other sanitation topics, visit http://www.remcoproducts.com/knowledge-center.

 

SELECTED REFERENCES:

Food and Drug Administration. (2015). FSMA final rule for preventive controls for human food.

Joint FAO/WHO Codex Alimentarius Commission, Joint FAO/WHO Food Standards Programme, & World Health Organization. (2003). Codex Alimentarius: Food hygiene, basic texts. Food & Agriculture Org.

US Food and Drug Administration. (2011). Food safety modernization act (FSMA). Public Law, 2011, 111-353.

Website: www.fda.gov

 

Common Food Industry Cleaning Problems Solved

The goal of any good sanitation plan is to minimize cross-contamination and cross-contact through better hygiene and cleaning practices. But—what happens when workers can’t feasibly reach that tall ceiling fixture or get a brush to follow the curves of a spiraling pipe? If employees don’t have the right tools for the job, they’ll end up improvising sub-par solutions, or—even worse—they just won’t clean that area.

Here are some examples of specialty tools solving common cleaning problems in food processing plants:

High walls

Standard handles just aren’t going to reach all the way up a factory’s walls. Use a telescopic handle to clean walls top-to-bottom. Because they’ll need to be adjusted many times, handles should be easy to extend and shorten. Ideally, they should also be hollow to minimize weight for worker comfort and to make the handles easier to control at longer lengths.

Ceiling and pipe condensation

Sometimes handled by makeshift tools like a sock on a telescopic pole, cleaning condensation is vital to food safety and deserves its own tool. Condensation dripping into food or processing equipment can lead to microbial cross-contamination and a costly recall. Use a condensation squeegee to prevent drops from forming and falling into products. A condensation squeegee catches and drains water from overhead into either tubing or bottles to keep products safe.

Large tanks

Specially designed tank brushes have curved heads to reach every angle. When combined with an easy-to-use telescopic handle, workers can reach to clean the tops, sides, and bottoms of tanks, all without having to pull out a cumbersome ladder.

Long pipes

Pipe brushes need to be the right diameter to reach the interior walls, but they also have to be the right length to reach through the pipe, or debris will build up just out of reach. Remco offers pipe brushes on stainless steel handles that can be lengthened again and again with 30-inch extenders to reach through the longest pipes.

Curved or helical pipes

Stainless steel handles are flexible, but only to a degree. For truly helical pipes, a nylon handle will follow all of its curves while being strong enough to get the pipe walls clean. Nylon is FDA-approved for food contact and can follow through even the most spiraling pipes.

Overhead pipes

Condensation isn’t the only worry when it comes to overhead pipes. These surfaces are often repositories for dirt and contaminants since workers have a hard time reaching around and over them to clean. Use an overhead adjustable-neck brush to get them clean. The brush should have a flexible head to reach over and on the side of pipes. An adjustable neck will allow workers to reach pipes at any angle. Combined with a telescopic handle, an overhead brush is especially useful for reaching high pipes.

Machinery with blades

Though ideally most bladed machinery like bowl cutters are disassembled for cleaning, often this isn’t the case. A brush with a hand guard to help protect workers allows dangerous machinery to be cleaned in place more frequently.

Cross-contamination and allergen cross-contact can both be prevented by better hygiene practices. When you’re able to fully clean your facility, you’re able to control the spread of contaminants. These tools can help solve your common cleaning problems.

 

What you need to know about FSMA: Part 1

If you are in the food industry and have had your eyes and ears open, then most likely you have heard the word FSMA being thrown around… a lot. However, some people might find themselves unfamiliar with the term or have limited knowledge of it, so in this entry we are going to cover some general information regarding FSMA and in upcoming blogs we will go into further detail about each proposed rule issued by the FDA that supports this legislation.

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The people, pathogens and food of today are not those of the past. Our population is living longer and with problems that make them more susceptible to foodborne illness complications. Pathogens are evolving and becoming more adaptable and harder to kill. Our food is traveling more than it ever has. For example, the FDA states that 15% of food we eat is imported. A total 75% of our seafood, 20% of our vegetables, and 50% of our fruit is imported. However, one thing has not changed and that is the threat that foodborne illness presents to the food industry and its consumers. Continue reading What you need to know about FSMA: Part 1

Using Color-Coding for Food Safety and Organization

Lately, I’ve been doing a lot of consulting with food processors to build and improve color-coding systems in their facilities. Color-coding can be approached in a variety of ways, and works well with a number of related programs. One such program is a lean manufacturing practice called 5S, which I encountered often in a previous position working in the steel industry.

I’m starting to see 5S used more often in food processing. Although I am not an expert in this system developed by the Japanese, I do know that the 5 S’s are Sort, Set in Order, Shine, Standardize, and Sustain. The aim is to eliminate waste, keep workspaces organized, and develop procedures that are consistently easy to follow. I can see why this set of guidelines is appealing to food processors. An organized processing facility is agreeable with inspection authorities, because it demonstrates that a food safety procedure is defined and in practice.

Color-coding for food safety

Color-coding is also commonly applied in conjunction with written food safety plans and HACCP programs to further enhance food safety. The purpose of HACCP and the CGMP regulations laid out in 21 CFR 110 is to identify and control hazards that could potentially impact the safety of food. Cleaning and food contact tools can potentially transfer hazards like pathogens and allergens throughout the facility, so it may be important to keep certain tools in designated areas. Color-coding supports this objective by clearly identifying where tools belong or what task they are designated to perform.

food safety color coding for controlled areas and tasks

Color-coding best supports food safety efforts when it is applied with simplicity. A best practice to keep in mind is that the way to create the most effective color-coding program is to implement tools in one solid color. Otherwise the program may become diluted and can introduce more confusion for employees.

Organizing tools with color

When food safety is a concern, it should take precedence over organizational efforts when building a color-coding program. A system like 5S is excellent in supporting a food safety program such as HACCP. However, colors should primarily be determined by the food safety program prior to defining organization principles related to 5S.

Fitting all of these programs together can be challenging, but it is possible and most definitely beneficial to food safety efforts. Anytime you need guidance or advice on building or revising a color-coding system in your food facility, you can call on Remco for support.

Food Contact Tool Storage Best Practices

In many of my visits to food production plants, I see outstanding food safety procedures that can be shared as best practices. One of the easiest and most beneficial best practices to adopt is proper storage of food contact and cleaning tools. Selecting the right tools for specific tasks can mean a significant investment of time and other resources. A good storage plan for those tools will help to protect that investment and enhance food safety efforts.

Wall with Full Red Bracket color-coded food contact toolsThe way a food contact or cleaning tool is stored is almost as important as the tool itself. Implementing a hygienic tool storage system takes some time and effort, but will also provide many benefits once set up correctly. These benefits include better organization, prolonged life of tools, and maintaining the sanitary conditions of tools.

From an organizational perspective, having a storage plan ensures that tools are where you need them, when you need them. Production line supervisors are able to check defined tool locations at the conclusion of each shift. Showing a visual representation of the tools designated for the area enables each supervisor to quickly verify if tools are missing and identify the correct part number for any tools that need to be reordered. Also, tools go missing less often when a storage plan is specified.

Tools that are stored neatly in an area that allows adequate space helps to keep them from colliding or bumping against other objects. Rough contact with other objects can potentially cause breakage, in turn introducing a risk for physical hazards in the facility. In addition, bristles on brushes and brooms can become misshapen and tangled if they are allowed to rest directly on the floor or other surfaces for extended periods of time. It’s a good idea to regularly inspect tools for wear or extraneous damage. If the storage method is contributing to wear, it’s time to make a change. Getting the maximum lifespan out of food contact tools translates to better operational efficiency.

The most important consideration of a storage system for food contact and cleaning tools is that tools are maintained in a sanitary state before being put to use again. Floors are a common surface in a facility for the transport of contaminants, so tools that have been cleaned should be stored off of the floor using a wall bracket or other sanitary mounting option. This is particularly imperative for tools that directly or indirectly contact food, as a tool that has touched the floor introduces a great risk of contamination. In this sense, designating a tool storage location that suspends tools off the ground can protect the integrity of your code-compliant facility and your end product.

Once the tool storage plan has been identified, it should be included in the written food safety plan for the facility. If you need help or guidance with your tool storage program, call Remco. That’s what we’re here for. We can help you determine the best practices to maintain hygiene in your facility. For more information, download a copy of our white paper, “Selection, Care and Maintenance Guide for Food Contact Tools and Equipment.”

Being a Food Safety-Minded Consumer

As a consumer with a passion for food and cooking, I know a thing or two about food safety in the kitchen. In my time at Remco, I’ve learned a lot more and have become acutely aware of all the considerations for the safety of our food as it moves from farm to fork. I am amazed at how much food safety professionals need to know in order to perform their daunting jobs.

Lettuce greens and food safetyI try to be aware of basic food safety guidelines in my kitchen. I use a meat thermometer to be sure the food is within the safe range, but also because I prefer not to overcook it. I avoid the cans with dents at the grocery, because the good ones stack better in the pantry—but also because some dents may compromise the integrity of the product. I clean my grill tools before flipping food if they’ve come into contact with raw meat, and I always use a fresh plate to bring food back inside.

Now that I’ve worked closely within the food industry for over three years, I’m starting to think a little differently about my own food safety. My new awareness goes beyond my own kitchen. Lately I’ve started to wonder about the food safety efforts at the facilities that produce the food I buy. And I’ll tell you, when I hear about a producer going above and beyond for food safety, it sticks with me.

A great example is Earthbound Farms—a California salad greens grower and packager. I read recently that they are BRC validated, which requires very rigorous third-party audits. As a consumer, the fact that they have pursued food safety validations above and beyond requirements tells me that they really care about the safety of their consumers. And they are very transparent about their food safety program. They’ve gained a loyal consumer in me.

With that being said, food safety in my kitchen now starts with getting to know a little bit more about where my food comes from—not just the temperature it arrives at when I’m done cooking it. I now seek information about the food safety programs of producers I purchase from, and I’m willing to spend a bit more if I know that they are diligent in their efforts.

CGMPs and HACCP: The Dukes of Hazards

In the past couple of blog entries, we’ve covered CGMPs or Current food Good Manufacturing Practices. These are procedures and standards set forth by the FDA to help assure safe, quality, consumable food.

salmonella biohazard food safety riskIn this article, we’ll be covering the different types of hazards that can occur in food processing, and also the controls that can be put in place to reduce the risk of those hazards. Many CGMPs exist to control these hazards, so naturally CGMPs can be used to support a HACCP plan.

So what constitutes a hazard? There are basically three types: biological, physical and chemical.

Let’s start with biological hazards. The Centers for Disease Control (CDC) has determined four levels of biohazards starting with Level One which includes bacteria and other microorganisms that can transmit from one person to another via contact or through the air like E. Coli. Each level is more hazardous than the previous, leading to Level Four which includes the most sever strains such as Ebola virus and Marburg virus.

Physical hazards are perhaps the easiest to understand. These include any extraneous objects or foreign matter that could cause illness or injury to a person consuming a food product. Bone chips, injection needles, wood fragments, pieces of packaging, insects or filth are just several of the items possible. Glass fragments physical food safety hazardSources of contamination can be from raw materials, improper production procedures or badly maintained facilities. Harken back to our blog article that referenced Upton Sinclair’s The Jungle and how it revealed the filth and unsafe practices of the meat packing industry in the early 1900s, and one could understand how such a list may have first been developed. CGMPs and other food safety regulations have advanced today’s food processing practices; however it is important to be mindful of how even the most minor change might introduce an opportunity for new physical hazards.

Finally, there are chemical hazards. Some of these, unfortunately, are unavoidable such as pesticides, herbicides, growth hormones and antibiotics, additives and processing aids, and lubricants. Sometimes, improper storage or usage of chemicals like cleaning compounds contributes to contamination of food. Allergens fall in the chemical hazard category, too. The top eight known food allergens reported by the FDA are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans. Thus, the FDA has established tolerance levels to keep chemical hazards in food at a minimum.

So how does a food processor control hazards? A good basic step is to develop a written food safety plan built around the CGMPs outlined by the FDA. These guidelines were created to assist processors in recognizing and controlling hazards. Processors can take due diligence a step further by building a HACCP plan. The first principle of HACCP is conducting a hazard analysis. Following HACCP principles is a thorough and systematic method of approaching quality control. HACCP planning guides processors in identifying and evaluating hazards and critical control points, and establishing a program to monitor, correct, verify and track any potential safety or quality hazards in the food production process. CGMPs can be used on their own or in conjunction with HACCP principles to keep hazards in check.

As the song goes, “we’re only human,” which is exactly why hazards can happen and controls are considered necessary to help minimize the risks of breaches in food safety. Through our experiences with various food producers over the years, we understand food safety is a subject that’s not taken lightly. At the minimum, any company producing food should have someone on staff who understands what constitutes a hazard that requires some effort to control. We continue to want to learn more about how different food producers are minimizing their risks. How does your company control hazards? What’s worked and what hasn’t? We’d appreciate hearing from you. Tell us your thoughts. And for more information on hazards and controls, check out our white paper Understanding GMPs.

What the Government Shutdown Means for Food Safety

As most of you know, our government went into a shutdown last Tuesday. What does that mean for the food industry? The FDA has said that they are maintaining 55% of their almost 15,000 person staff. But since food safety inspectors are considered nonessential, almost half aren’t working during this shutdown. What’s left of the staff will handle emergencies, high-risk recalls, and investigations. On the other hand, most of the meat inspectors for the USDA will continue to work, at least for the time being. But, since the FDA is responsible for about 80% of the food supply, and about a 1/5 of our food supply comes from overseas, we could have a situation on our hands if this shutdown lasts for much longer. The longer food processors go without inspections, the higher the chance of an outbreak. And, the CDC, which monitors foodborne illnesses, also has furloughed employees, only operating at 32%.

family picnic with processed foodEven these agencies’ social media accounts are feeling the hit. Considering that many people get news of recalls, food related illnesses, and other industry news from social media, the public may become more concerned if the shutdown goes on for a while. Also, according to Food Safety News, those furloughed employees aren’t even allowed to check their work email. Here’s what some of agencies tweeted shortly after news of the shutdown:

USDA Food Safety @USDAFoodSafety- “Due to the lapse in federal government funding this channel will not be updated until the federal government reopens.”

U.S. FDA @US_FDA- “We’re sorry, but we will not be tweeting or responding to @ replies during the government shutdown. We’ll be back as soon as possible!”

CDC @CDCgov- “We’re sorry, but we will not be tweeting or responding to @ replies during the government shutdown. We’ll be back as soon as possible!”

Even though there might not be FDA inspections happening right now, we still know that food safety is in full force. That’s because all the hard work related to food safety happens inside the food production facility. Many food processors have and will continue to be their own food safety inspectors. And these companies will be ready for inspections when they resume, as they were before the shutdown happened. It’s these companies that prove that food safety goes beyond the regulations and inspections. Because, isn’t it the right thing to, not just for us, but for our children’s safety? It’s definitely something to think about.

The Birth of Food Safety, the FDA and CGMPs

Lately, we’ve been talking about Current food Good Manufacturing Practices—CGMPs for short—because they are the set of regulations that apply to just about every food processor not regulated by the USDA. CGMPs have also been getting quite a bit of press lately since we may see an update as a result of FSMA. We released an earlier blog article and a white paper on the topic for those who want to learn more.

But did you know that many of the regulations that guide the production of today’s food were largely spawned by the works of investigative journalists? These journalists were referred to as “muckrakers,” and they exposed government and business corruption.

food safety and 1900s meatpackingOne of the most well-known of these journalists was Upton Sinclair, who spent seven weeks working undercover in the Chicago meatpacking district on a research mission to expose the injustices and hazardous working conditions faced by meat industry workers. In Sinclair’s novel, The Jungle, his vivid descriptions of the unsanitary practices of the meatpacking industry captured the attention of the American public and President Theodore Roosevelt.

After reading The Jungle, Roosevelt sent a pair of advisors to assess the truthfulness of the novel’s depictions—and their report swayed the President to believe that Sinclair had provided an accurate representation. Shortly after Sinclair’s works became widespread, the Pure Food and Drugs Act and the Meat Inspection Act were passed in 1906. The passage of these regulations marked a turning point in federal food safety and was the beginning of what we know today as the FDA.

Although Sinclair had hoped that his accounts would improve working conditions for America’s poor laborers, he ended up making a huge and lasting impact on food safety. He was later quoted as saying, “I aimed for the public’s heart, and by accident hit it in the stomach.”

The early regulations were more specific about the standards for pharmaceuticals and accurate product labeling, and policies regarding food were much more ambiguous. Over the next 30 years, gaps in the protections provided to consumers by these regulations were exposed by a new generation of investigative journalists. In 1938, President Franklin D. Roosevelt signed the Food, Drug, and Cosmetic Act, received enthusiastically by an American public that had witnessed one too many food and drug safety disasters. This was the first law that mandated legally enforceable food standards, and CGMPs for food were officially established later on in 1969.

No one can deny that we have come a long, long way for food safety since the days written about by Upton Sinclair. But we may soon see another era of modernization of our food safety regulations. Do you think that the updates proposed by FSMA go far enough in preventing the production of unsafe foods? Are there holes in today’s laws you think should be considered? Tell us your thoughts.

Five Types of GMPs for Food Processing

Assuring quality of a manufactured product requires certain procedures and standards. In many industries, these procedures and standards are often referred to as Good Manufacturing Practices, or GMPs. The Food and Drug Administration (FDA) outlines Current food Good Manufacturing Practices, or CGMPs, in Title 21 of the Code of Federal Regulations, Part 110 (21 CFR 110).

The FDA provides CGMPs to assure that food processors maintain sanitary conditions that minimize the risk of contamination by “hazardous” materials. We’ll cover what the FDA considers hazards in a future blog entry. But for now, we’ll focus on CGMPs.

So what aspects of a food processing operation should be controlled and monitored to assure they conform to CGMPs? Through working with food processors, we’ve found that just about every aspect of a food processing operation might come under scrutiny during an inspection — from the personal hygiene of the workers in the plant, to the equipment used to make the food products, to the processing facility itself.

The FDA outlines CGMPs in five subparts:

1. General Provisions — Do you know the terminology that should be used in describing CGMPs? This first section provides guidelines. It also explains when to use “shall” versus “should” in differentiating between when compliance is necessary (“shall”) and when procedures and practices are directly related to insanitary conditions as specified in Section 402(4)(a) (“should”). It also delineates plant and employee responsibilities with regard to personal hygiene. Food safety education is addressed as well as the need for supervisory personnel to ensure compliance.

2. Building and Facilities — How should a facility be designed and maintained to help assure food safety? In this section, CGMPs are outlined for the maintenance of the grounds, including litter control, waste removal and treatment, and grounds maintenance and drainage. Plants should be designed and built to reduce the potential for contamination. Sanitary operations, facilities and controls are also outlined.

3. Equipment — This section provides requirements and expectations for the design, construction and maintenance of equipment and utensils to ensure sanitary conditions. But did you know it also includes an automatic control for regulating temperature or an alarm system to alert employees to significant change in temperature? Other requirements are general and intended to prevent contamination from any source.

4. Process and Controls — How should a food processing facility keep sanitary conditions in check? This section of CGMPs addresses general sanitation and controls necessary to ensure that food is suitable for human consumption. It addresses the monitoring of physical factors (critical control points or CCPs), such as time, temperature, humidity, pH, flow rate, and acidification. Warehouse and distribution requirements are also included, requiring finished foods to be stored and distributed under conditions that protect against physical, chemical and microbial contamination. The container must also be protected from deterioration. This section also outlines very general requirements for warehousing and distribution.

5. Defect Action Levels — There may be unsanitary circumstances that are simply inescapable. So how does the FDA address this? This last part allows the FDA to define maximum defect action levels (DALs) for a defect that is natural or unavoidable even when foods are produced under CGMPs (as covered in the sections above). These defects are not hazardous to health at low levels and include rodent filth, insects or mold. Those exceeding maximum DALs will be considered in violation.

We continue to appreciate the diligence our food processing customers demonstrate in following CGMPs to assure high-quality food products. What are your facility’s CGMPs, and how do you verify that your operation is in compliance? As you have gained experience in the industry, are there any types of required controls that surprised you? What other aspects of food processing do you think should be controlled that aren’t currently covered in regulations? We’d love to hear more about the policies and procedures that have been successful for you. And to learn more about food safety practices and CGMPs for food processing, check out our white paper, Understanding GMPs in Food Processing.