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 the 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”

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 severe strains such as Ebola virus and Marburg virus.

Continue reading “CGMPs and HACCP: The Dukes of Hazards”

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 the 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

Remco Products Inc.

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 unsanitary 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.

Five Things You Maybe Didn’t Know About HACCP

If you work in food processing, chances are you’re probably familiar with the concept of a Hazard Analysis Critical Control Point or HACCP. Here’s a little about what we’ve learned about HACCP.

HACCP food safety sample verificationAs part of a HACCP Plan, a Hazard Analysis identifies “Critical Control Points” or CCPs — those points, steps or procedures in food manufacturing process at which control can be applied and as a result, a food safety hazard can be prevented, eliminated or reduced to an acceptable level. With CCPs identified, a HACCP Plan provides a series of procedures to control the process and sensitive points in the food chain, with the ultimate goal of producing foods that are safe for consumers’ health.

HACCP is a part of the Food Safety and Modernization Act (FSMA) proposed by the Federal Drug Administration (FDA) in 2011. While FSMA is fairly new, did you know the concept of HACCP has actually been around for some time? Here is the answer to that question along with some other interesting things about HACCP that many people may not be aware of.

1. HACCP is not a new system.

HACCP is a concept that’s been around since the 1960s. It was developed by the Pillsbury Company, the US Army Laboratories and NASA to help produce safe food for space missions. Today, HACCP is a recognized international standard for safe food production. It is endorsed by the Food and Agricultural Organization (FAO), the World Health Organization (WHO), and in the United States by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF).

2. Not every hazard is a CCP.

As part of putting together a HACCP Plan, there’s a thought-process or Decision Matrix one can use to review each step in a food workflow process and determine the likelihood of hazards that could occur. Once a hazard is identified, then it is evaluated whether or not it is a CCP. Going through this evaluation, one will soon discover that not every hazard is a CCP. If a control measure is already in place to address the hazard, then chances are the hazard is not a CCP.

3. It takes a team to put together a HACCP Plan.

Through our experiences working with food processors, we’ve seen that some of the best HACCP Plans are the result of a team effort by the key individuals responsible for food safety within a food processing operation. The team may include managers from quality assurance, plant operations, engineering, maintenance, sanitation, and shipping & receiving. In addition, it’s often advised that someone who works on the line, such as a Line Supervisor and/or Machine Operator, provide input to the HACCP Plan to help assure alignment with day-to-day operations.

4. One person should be responsible for the HACCP Plan.

While it often takes a team to put together a well-structured HACCP Plan, we’ve also observed that maintaining the plan should ideally be the responsibility of just one person within a food processing organization. That person is usually the HACCP Coordinator. However, if there is no HACCP Coordinator, then the responsibility often falls to the Quality Manager, or even the company’s CEO.

5. Review the HACCP Plan regularly.

In a perfect world, anytime something changes within a food process, then the HACCP Coordinator should review the HACCP Plan and update it accordingly. At the very least, it’s suggested that a HACCP Plan be reviewed every 3 to 6 months.

How does your food processing facility deal with HACCP? If you have any additional tips or observations about putting together and maintaining a successful HACCP Plan, we’d love to hear them.

10 Things to Know About Color-Coding: Zones and Critical Control Points

Understanding Zones and Critical Control Points in Color-coding

Just about every food processor knows that complying with food safety regulations from the FDA and other regulatory bodies is a vital aspect to the success of their overall operation. Without achieving this compliance, it would be fairly difficult to run an effective food processing program. The list of recalled food products seems to grow every day, most being the result of some sort of cross-contamination, and those recalls can cost millions of dollars. The old adage, “better safe than sorry,” definitely comes into play when talking about protecting against recalls. Color-coding is one simple method to help keep your food processing operation as “safe” as possible.

One of the most important FDA-proposed rules is HACCP. Complying with HACCP regulations is an important part of any food processing operation, and knowing where the critical zones are and preventing cross-contamination from happening is an integral part of this compliance. Currently, there are HACCP procedures for dairy, juice, retail seafood, and retail and food service.

Let’s back up for a second, HACCP stands for Hazard Analysis and Critical Control Points. HACCP is a preventative approach to the identification, evaluation, and control of food safety hazards that may cause illness or injury when not properly controlled. Put simply, HACCP is designed to help control the threat of cross-contamination from biological, chemical, and physical agents. According to the FDA, “any action or activity that can be used to prevent, eliminate or reduce a significant hazard” is considered a control measure. Color-coding is an excellent example of a control measure.

Once potential food safety hazards are identified, critical control points can be documented. The FDA defines a critical control point in a food manufacturing process as “a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.” Knowing where the critical control points exist in a food production process is essential to designing an effective HACCP plan.

Included in the many HACCP compliance resources available from the FDA is an example of a decision tree to help a food processing operation identify critical control points, seen below. Using a decision tree like this is not a mandatory part of the process, but it is valuable as a tool to facilitate the development of a thorough food safety program.

FDA Example of Decision Tree

Since color-coding is a control measure, color-coding zones often coincide with critical control points or groups of critical control points. For instance, a color zone may be assigned to an area where raw meat exists in a facility, since raw meat poses increased risks of bacterial contamination. There may be several critical control points that require other control measures within that one color zone, such as testing for contaminants or refrigeration of the raw meat prior to processing. Once the meat has been cooked, a different color may be assigned to the zone following the raw meat area to prevent bacterial cross-contamination into the finished product. For this purpose, color-coding is an excellent and simple way to visually confirm that equipment is in the appropriate critical zone in a food processing facility.

When color-coding is implemented, it is easily apparent which zones are which, and what they represent. Because of this instant recognition, separating contaminated food before it goes out to the public becomes easier. And we all know that internal recalls (or no recalls!) are less costly than public recalls.

To find out if color-coding is appropriate for your food processing facility, download our worksheet below.