The Food Safety Act Wants to Catch Outbreaks Before They Start

This blog post is a 25 minute read

Food safety inspections are an important part of the industry that grows, produces, and distributes our food. About one in six Americans—around 48 million—get sick every year from foodborne illnesses. Even more alarming nearly 128,000 are hospitalized, and 3,000 people die each year from foodborne diseases according to the Centers for Disease Control and Prevention.

Strengthening our food safety system is intended to save lives and reduce illness. Industry participation with federal regulators’ oversight is central to a functioning system, but the complex regulations themselves can be confusing. The history of food safety in the United States provides some context as to why such programs are needed but unwinding the webs of federal rules to determine who is covered by which regulations and how they will be implemented can be tricky. In this post, we’ll look at what the Food Safety Modernization Act is, what the key provisions of it are (and who is affected), and how to build a smart risk-based program that incorporates best practices for managing microbial, chemical, and physical hazards at your plant.

What is the Food Safety Modernization Act?

The Food Safety Modernization Act (FSMA) is the first major overhaul of the regulations governing food safety in the US since 1938. It was passed into law in 2011 and signed by President Obama. Like many federal laws, the name is a bit unwieldy and so it is often referred to as the Food Safety Act or the FSMA—just as we’ll do in this piece.

Microbes causing food-related illnesses have a DNA profile that allows trace back to the raw material and to the manufacturing plant doing the packaging (click above to view full version).

There were a few factors that led to the belief that legislative changes were necessary to update the laws that governed food safety. The advent of several high-profile incidences of widespread foodborne illness outbreaks—that included such diverse products as Salmonella in peanut butter, and issues with raw juices, honey, farmed fish, hamburgers, fresh spinach and cookie dough—and potential vulnerabilities that might exist in our food system that might make it susceptible to bioterrorism were big concerns. Identifying these risks and concerns and then proposing legislative fixes for them on this scale takes time. Changes were first introduced and debated in 2009 and 2010, leading to the creation of working groups, a task force, and a lot of input from affected parties. After much discussion and debate, the Food Safety Modernization Act passed in 2011, with multi-year implementation plan starting with education. One of the key differences put into place by the law is that food safety is no longer a reactive process of addressing outbreaks when they occur—the idea behind much of the direction in the law is to prevent as many outbreaks as possible from happening in the first place, and then responding quickly and efficiently when they do. This concept builds off Hazard Analysis Critical Control Point (HACCP) plans that were implemented in juice, fish, and milk industries in earlier decades. Changing the focus to prevention means fundamental changes in how those who process food for human consumption must do business. The law also significantly increases the FDA’s authority to monitor food that comes into the U.S. from other countries.

FSMA Key Implementation Dates (click above to view full version)

Passing legislation is one step, and the next is implementation. Implementing a law such as the Food Safety Act means that the regulatory agency (or agencies) involved develop agency rules, which have the force and effect of law—these are the federal regulations that govern food producers under FSMA.

A Short History of Food Safety Laws

The government agency spearheading compliance is the Food and Drug Administration (FDA), which is the same body that was first tasked with food safety by Congress. In 1906 the Pure Food and Drug Act was passed to regulate interstate commerce of food and drugs, and the oversight provisions in that law led to the eventual formation of the FDA. Prior to the passage of the Federal Food, Drug, and Cosmetic Act (FFDCA) in 1938, there was little regulation that governed the safety of foods, medicines, and cosmetics. In 1937 a pharmaceutical company developed a sulfanilamide medication—a form of an antibiotic—that contained a poisonous solvent called diethylene glycol. Source. It seems hard to believe now, but at the time the level of toxicity was not widely known or understood—and it was added to a medication that was ingested. More than 100 people died after taking the medication, and public outcry led Congress to pass the FFDCA, which among other things required products to be tested before they could be sold to the public. Over the intervening years, additional laws have passed that were more limited in scope, such as the Fair Packaging and Labeling Act of 1966 and the Food Quality Protection Act in 1996. The Food Safety Act that was passed in 2011 is the most substantive overhaul since the 1938 law was passed.

What Are Some of the Key Provisions of the FSMA?

The three primary foundational rules that the Food Safety Act covers are the: Produce Safety Rule, the Preventative Controls Rule, and the Foreign Supplier Verifications Program rule. The Produce Safety Rule governs food and farming operations that grow, pack, or hold food, and the Preventative Controls Rule governs facilities that process food that is then distributed for human consumption. The Foreign Supplier Verifications Program rule governs those who import food into the U.S. The scope of the Food Safety Act is considerable, and the FDA was granted considerable new authority under the law. As noted earlier, industry participation with risk assessment and prevention is a key goal. The law requires mandatory preventative controls for food facilities, which include the need for written prevention (Risk Analysis and HACCP) plan that takes into account what hazards might be present that could compromise food safety. It also requires a clear plan—in writing—as to what steps and controls must be in place in order to mitigate any hazards including validation of effectiveness, verification of on-going practices and a recall plan should these measures fail.

In addition to industry mandatory participation and prevention, other areas of broad authority for FDA are in inspection and compliance; response when problems are identified; regulating imports; and spearheading necessary partnerships with other agencies (international, state, and local) to ensure compliance.

Is Training Available to Assist with Food Safety Act Compliance?

The Food Safety Act was designed to improve the U.S. food safety system by emphasizing three core strategies: a focus on risk assessment and prevention, increased surveillance to detect problems early, and better response and recovery when problems do surface. Because the scope of the law is enormous, touching on virtually every aspect of getting food from a farm to the table, training is available, important, and required. The FDA does not conduct trainings themselves, but instead partners with public-private groups and alliances that administer training of FSMA-compliant curricula. Trained Preventive Controls Qualified Individuals (PCQI) stationed in the plant and who are available for audits and inspections are integral to the success of the information transfer to the food production plants required to implement FSMA.

The established Alliances are where the majority of food producers will receive training. The Produce Safety Alliance (PSA) and the Food Safety Preventative Controls Alliance (FSPCA) are two well-established programs, each of which has a target audience. PSA offers a training course for growers that covers agricultural best practices and produce safety requirements and developing a farm food safety plan. FSPCA focuses on training for Preventative Controls rules compliance, which has two separate tracks, one designed for those who handle and produce animal food, and another for those who are involved in the production of food designated for human consumption.

Agencies focused on certain food manufacturers have a deep understanding of the microbial, chemical, and physical hazards challenging the industry and putting the food at risk. In partnership with suppliers, and food safety device manufacturers, like Charm Sciences, risk management strategies are developed, monitored, and  maintained. Additionally, other government organizations have started systems aimed at preventing outbreaks. Each year, around 1,500 clusters of diseases are discovered by state health agencies. The CDC also started the program PulseNet, a system that uses DNA fingerprinting of bacteria causing illness to detect outbreaks. Since starting in 1996, PulseNet has been able to prevent an estimated 270,000 illnesses.

Moving Forward

Although the Food Safety Act has been the law for a number of years, there are still parts of it that are yet to be fully implemented. There is a requirement that rules enacted be based on data and science—and sometimes that can make developing a rule tough. One of the most significant components of the law that remains on hold is the development of standards for testing agricultural water.

 When government agencies propose rules, they are posted for public feedback, and the feedback the proposed agricultural water testing rule received was that the testing criteria were too complex and difficult to implement—so FDA has issued an extension for compliance and is revising the rule. Consumers want food they can trust, whether it’s for their table or for their pets. While a prevention mindset and mandatory recalls when there is a problem are good steps, much of the reputational burden will fall on the industry. The fewer recall headlines there are, the more the public’s trust will build. Producers can take the important steps of making certain they are compliant, receive the necessary training, and develop sound plans for monitoring and remediation.

Keeping Your Products Safe

The Food Safety Act’s focus on microbial and chemical hazard prevention is one that Charm knows a lot about—our food safety solutions are designed to meet a wide range of needs. Contact us today to learn more about how our sanitation monitoring, microbial detection, and chemical prevention solutions can help you meet the requirements of the FSMA.

About Charm Sciences

Established in 1978 in Greater Boston, Charm Sciences helps protect consumers, manufacturers, and global brands from a variety of issues through the development of food safety, water quality, and environmental diagnostics tests and equipment. Selling directly and through its network of distributors, Charm’s products serve the dairy, feed and grain, food and beverage, water, healthcare, environmental, and industrial markets in more than 100 countries around the globe. https://www.charm.com

Challenges When Testing for Enterobacteriaceae

This blog post is a 23 minute read

In the food and beverage industry, there are few things as important to quality and reputation as microbial safety.

The Centers for Disease Control and Prevention (CDC) estimates that each year, around 9.4 million Americans will get sick from a foodborne illness. Studies that have examined the cost of recalls estimate that the average cost of a food product recall in the U.S. is $10 million—and there are hundreds of recalls every year.

With this in mind, there is clearly a lot to be considered when selecting the right microbial indicator test and method of sampling.

Let’s take a close look at what indicator testing is, some of the challenges of conducting testing, and what factors are important to consider when picking the right test to meet specific situational requirements. In this example, we’re looking at the situation requirements of the poultry industry and why Enterobacteriaceae is used as one of the indicator microorganisms in that industry.

What is Indicator Testing?

Indicator testing detects generic strains of bacteria, as opposed to testing for specific organisms or pathogens. Enterobacteriaceae are a large family of different types of bacteria containing generic coliform and E. coli subgroups. Enterobacteriaceae (EB)  are commonly found in fecal material, which nobody wants in their food.

Source.

Many EB are harmless, but may be more prevalent in certain industries, such as poultry, and are closely related to pathogens frequently named in the news during outbreaks. Some of these Enterobacteriaceae pathogens are Salmonella, Shigella, Yersinia, and hemorrhagic E. Coli.

Indicator testing is useful for monitoring broad microbial trends of commonly found and easily tested microbes, like Enterobacteriaceae, rather than hunting for exact matches of less frequently found and harder to detect pathogenic bacteria. Because pathogenic bacteria can be hard to detect, poultry indicator testing, such as Enterobacteriaceae, broadly looks to identify the relatives to pathogens, such as Salmonella, that may be present in the food production process.

This is beneficial for two reasons. First, many kinds of pathogenic bacteria typically exist in the environment at low levels, making them difficult to find and testing for these pathogens can be very expensive.

And second, because this kind of testing detects more common and prevalent generic strains, it can be an important bellwether showing that the right conditions exist for pathogenic bacteria to flourish. Indicators are common bacteria that serve as indirect warnings that more dangerous bacteria are likely to be present.

This allows for proactive remediation and cleaning of surfaces on the indicator result, rather than the long wait, where surfaces can be potentially harboring harmful bacteria, potential product hold or plant shutdown, and detailed notification/follow-up testing that has to occur to verify the existence of a pathogen.

Simply stated, indicator testing is like a warning light blinking on your dashboard—it gets your attention and tells you some kind of mitigation is necessary.

Testing Challenges

Traditional methods of bacterial indicator testing require preparation time and proficient lab skills. Unfortunately, due to a lack of microbiological expertise in food plants, samples are frequently sent out to an offsite third-party lab for culturing and results. This is almost always a more time-consuming and expensive route than onsite testing, whether that means using the standard method pour plates or an alternative, ready-to-use method.

There are many different onsite testing methods available, but how do you know which one is right for your facility? Even some of the faster, ready-to-use microbial test options available for onsite testing can be problematic, mostly when trying to determine their results.

Image Source.

Some require the use of a spreader device, which can cause the test sample to spread outside of the testing area, even when performed by an experienced technician. When this occurs, the test is invalid and requires time-consuming (and expensive) retesting. When interpreting results, methods requiring gas and acid halo-identification can provide ambiguous, hard-to-read results. This necessitates significant in-house expertise to conduct, read, and interpret tests because this isn’t a time for guesswork.

Conducting Enterobacteriaceae indicator testing with Peel Plate® EB Microbial Tests is faster than traditional methods and older, ready-to use tests, allowing for speedier remediation and less downtime. Peel Plate® tests were specifically designed to be easy to use and easy to interpret by using color indicators.

For example, to read the results in the image below you must determine which colonies are associated with gas bubbles and/or yellow halos to identify the EB colonies. This differentiation requires training and expertise.

3M™ Petrifilm™ Enterobacteriaceae Count Plates

In contrast, to determine the results in the next image, all you need to do is count the colonies.

Charm Peel Plate® EB Microbial Test

The second test is easier to prepare, due to a self-wicking medium that doesn’t require a spreader device. It is also easier to read and interpret—just count all of the colonies that show up on the test, regardless of size, color, gas production, etc.

Poultry Industry Testing

A recent CDC report confirmed that chicken was the most frequent cause of foodborne illness outbreaks in the U.S., comprising 12% of the confirmed cases. While only a small percentage of the reported illnesses in the U.S. are connected to recognized outbreaks, poultry safety is a top priority for manufacturers and government agencies.

The poultry processing industry is under constant scrutiny from regulatory bodies in the United States. USDA-FSIS inspectors work onsite at processing plants conducting daily inspections and pulling product samples for microbial (pathogen) testing. Concurrently, plants are required to self-monitor their manufacturing and sanitation processes by performing their own additional indicator and pathogen testing. Plants are allowed to use their data to show due diligence in their microbial control and sanitation efforts.

Plants are scored by regulatory agencies on a scale of 1-3, based on pathogen test results:

• Facilities with a score of 1 are considered in microbiologic control and have “achieved 50 percent or less of the maximum allowable percent positive during the most recent completed 52-week moving window.”
• Facilities with a score of 2 are considered marginally in control and have met “the maximum allowable percent positive but have results greater than 50 percent of the maximum allowable percent positive during the most recent completed 52-week moving window.”
• Facilities with a score of 3 need some improvement and have “exceeded the maximum allowable percent positive during the most recent completed 52-week moving window.”

In short, a score of 1 is good, and a score of 3 is problematic.

FSIS inspectors use buffered peptone water (BPW) to conduct tests of raw poultry. BPW is essentially a sampling medium that helps food safety inspectors recover Salmonella and other pathogenic bacteria in raw poultry. Many of the existing indicator tests for poultry on the market are not validated specifically for poultry testing.

Image Source.

The industry needs a simple-to-use, affordable test method that provides accurate and timely results when testing a variety of food and environmental matrices.

Charm Peel Plate EB Microbial Tests

Charm’s microbial test addresses many of the common challenges of Enterobacteriaceae testing. In addition, this test has been validated by OMA for specific industry uses, including poultry carcass rinse testing in BPW.

OMA (the Official Methods of Analysis program of AOAC International) validation is recognized worldwide, something ever-important in today’s global marketplace.

Charm’s Peel Plate EB Microbial Test is an easy to use, easy to understand test for Enterobacteriaceae that produces fast results (24 hours). And, it’s approved specifically for poultry testing with BPW, which is used by most processors.

With the availability of a validated indicator method for Enterobacteriaceae in poultry rinse with BPW, industry members can take steps towards aligning their sampling methods with the USDA-FSIS method and performing their required testing with just a single test sample. This sample can be used for both indicator testing and required pathogen testing and meets the FSIS sampling requirements.

Not only are the tests easier to interpret and faster to perform than other indicator test methods, they also comply with FSIS sampling requirements. The tests are easier to justify and defend during audits and inspections.

This sample can be used for both indicator testing and required pathogen testing and meets the FSIS sampling requirements.

Don’t Just Take Our Word for It…

We’re of course proud of the Peel Plate EB Microbial Test, but what matters most is how the product works for our customers. Here’s what one customer had to say about the Peel Plate EB test:

“Charm Peel Plates have provided exceptional benefits to our manufacturing plant. The ease of use was a must have for us. We were able to teach plant operators, who have no lab background, how to dilute and properly plate, incubate, and read samples without having to hire additional staff.

Prior to implementing the program, there was a lot of lead time waiting on results and hoping what we made was good. We would send out 5-6 samples to the lab for a single lot of product. Now, we can plate our samples, wait the short period for the results, and package or immediately implement corrective actions. We are down to sending one sample out per lot as a formality and confirmation of results. The plates have saved us significant time and money.”

Using Charm’s Products to Keep Your Facility Safe

Microbial indicator tests are an important low-cost and simple approach used by the food industry to verify their sanitation control programs and reduce customer risk spoilage and disease by monitoring microbial levels. The poultry industry is an excellent example of a proactive food supplier that performs these tests, choosing EB as an indicator because of its relationship to a Salmonella risk.

But there remain cost and performance challenges that need solutions. Charm Sciences is helping the food industry address those challenges with low cost, simple-to-use tests and sampling methods that are validated for their intended purpose. Saving our customers time and money while protecting their brand with accurate, easy-to-use tests is what Charm Sciences work towards every day.

If you’re in the poultry processing or food industry and want to try Charm Peel Plate EB Microbial Tests, please contact us. We’ll work with you to select the right combination for a free trial.

About Charm Sciences

Established in 1978 in Greater Boston, Charm Sciences helps protect consumers, manufacturers, and global brands from a variety of issues through the development of food safety, water quality, and environmental diagnostics tests and equipment. Selling directly and through its network of distributors, Charm’s products serve the dairy, feed and grain, food and beverage, water, healthcare, environmental, and industrial markets in more than 100 countries around the globe. https://www.charm.com