Tips For Complying With New Food Safety Regulations

By Doug Pedersen, Sesotec Inc.

It should come as no surprise that the food industry faces an incredibly high bar when it comes to federal and state regulation. The reason is simple: Safe food is the fuel of life. Little wonder then that the Food & Drug Administration (FDA) regulates the industry with such a tight leash. It‘s not an accident that „Food“ is the first word in the agency‘s name.

Now that we‘ve established the overall importance of food and the integrity of the supply network, let‘s turn to some new requirements promulgated by the FDA in its landmark new Food and Safety Modernization Act (FSMA).

Here Comes the FSMA

Signed into law by President Obama in January 2011, FSMA tasks the agency with strengthening the food safety system, featuring a special emphasis on prevention. The stakes are high, and the challenge is very real. Nearly 48 million Americans get sick, 128,000 are hospitalized, and 3,000 die each year from food-borne diseases, according to the Centers for Disease Control and Prevention (CDC).

Over the next several months and years, FSMA will phase in new sweeping regulatory powers for the FDA. Those include:

• Mandated Inspection Frequency: The FSMA establishes a mandated inspection frequency for food facilities based on risk. All high-risk domestic facilities must be inspected by 2019.
• Records Access: FDA will have access to records, including industry food safety plans and the records firms will be required to keep documenting implementation of those plans.
• Mandatory Recall: The FSMA gives FDA new authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after an FDA request. As we know, product recalls become big news quickly on TV and in other media. It‘s hard to repair the public relations damage done by a product being so publicly attacked. Here Comes the FSMA Secrets of Effective Food Safety Programs
• Suspension of Registration: In addition to new powers to detain products, FDA will be able to suspend registration of a facility if it finds the food poses a „reasonable probability“ of serious adverse health consequences or death.

It‘s the same north of the U.S. border, where the Canadian Food Inspection Agency (CFIA) recently issued new, and mandatory, federal licensing requirements for all food makers, importers, and exporters. The new requirements will align Canada‘s standards with those of the United States and other nations. The updated Safe Food for Canadians Act requires companies to develop and implement scalable preventative control plans in their facilities, among other mandates.

Clearly, the regulatory landscape has changed significantly for the food industry. The good news is that these new demands will almost certainly improve food safety and the supply network. The bad news is that they present some serious compliance challenges.

Secrets of Effective Food Safety Programs

The key to any effective food safety program is the containment of pathogens or foreign contaminants. Current Hazard Analysis and Critical Control Points (HACCP) programs and International Featured Standards (IFS) provide the blueprint for best managing these risks. The IFS PACsecure, a certification standard for primary and secondary packaging materials, is benchmarked to the Global Food Safety Initiative (GFSI). Product purity threats from pathogens include failure to set and implement high and consistent sanitation standards, and inconsistent product thermal management at the hottest and coldest ends of the temperature spectrum. It‘s a basic and undeniable fact that foreign materials exist within food products. It‘s a basic reality that comes with mass food production, and there‘s no way around it.

However, maintaining the highest levels of Product Purity against invasive foreign materials depends in part on having a genuine awareness of where and how these invaders reach the product. Next, the facility must determine what it must do to manage and remove those contaminants.

A thorough foreign material inspection plan must be divided into three main areas:

“Canada and the United States are significantly raising the regulatory bar for the food supply chain. Companies can use this opportunity to improve their operations and harness new technologies and implement best practices to improve quality, comply with new regulations, and drive profits.“

• Raw ingredients
• In-process
• Final Inspection

 

 

Any effective program includes provisions for multiple inspection areas and the use of several types of technology (e.g., Sesotec Inc. magnetic separation, metal detection, and x-ray inspection).

Focus: Final Inspection

While it may not be self-evident, it is sometimes best to begin with an assessment of a facility’s final inspection process and capabilities and then work backwards. Typically, the final metal detector or an X-ray system on the finished product is defined as a critical control point (CCP) as part of any HACCP plan. From a compliance standpoint, this may be the most important contaminant detection system. However, it still might not be able to guarantee the level of Product Purity a facility needs and expects.

If the facility has implemented a thorough Product Purity program „upstream“, then its end-of-the-line detection system will serve as the true measurement of how well the overall program is operating. Ideally, the end-of-the-line system should never reject a package. There are tools in the marketplace that can become a foundation for a strong program. Sesotec Inc. provides customized systems including the C-SCAN GHF multi-frequency metal detection system. This innovative metal detector will automatically calculate the optimum parameters required for highest detection of all metals. It also incorporates performance audit software, a useful tool for HACCP compliance when the detection system is a CCP.

Focus: In-Process

Moving upstream now to the in-process area, contaminants introduced at this point are likely the result of process machinery wear, breakage, or a flaw in the raw ingredients. Here‘s the tricky part: By the time a contaminant has been spotted at the in-process area, it is often shattered into pieces. That makes it smaller and more difficult to trace.

Sesotec Inc. can customize its inspection system to suit the type of food being manufactured. The Sesotec LIQUISCAN pipeline system is used while pumping products in process. Wide belt Sesotec metal detection systems with slide retract conveyor are positioned after freezing tunnels, coolers, or enrobing equipment, ahead of the packaging lines. This is important because these systems provide high detection levels and are not affected by any limits imposed by packaging.

Sesotec Rare earth magnets are often used at the In-Process area of the plant to trap sand-like ferrous fines produced by size reduction machinery. These fines can cause discoloration in the final product as well as trigger false rejects with metal detection equipment upstream.

Sesotec RAYCON X-ray technology can also be used at the In-Process area on raw meats or bulk flowing products to inspect for dense contaminants such as bone, natural rubber, or glass or when there is cause for more enhanced inspection at this stage in the production process.

The in-process detection system is typically not a CCP, but plays a vital role in achieving Product Purity and reducing production costs, as foreign material is removed before extra production overheads such as cooking, refrigeration and, labor are applied to product that would be wasted from a large product hold that ends up being thrown out.

Focus: Raw Ingredients

The production process begins with the raw ingredients. Unfortunately, too often this is a neglected area for contaminant management. That neglect comes with a price: the earlier in the system contaminants are caught, the greater the cost savings.

It may sound obvious, but industry inattention here suggests it merits more discussion in this paper.

A contaminant detected at the earliest stage will be removed from the line before it is reduced in size and other ingredients are added to it. Catching it early can also save bearing the costs of cooking, labor, and packaging, among others. Contaminants in raw ingredients will damage processing equipment, which in turn causes more contaminants. The result is very expensive — and probably avoidable — downtime.

However, removing contaminants at the front end saves significant waste that is often not accounted for at the finished end. In other words, it is important to demonstrate to others at your facility that money spent in the front end of the process is money well spent down the line.

The Sesotec - GF4000 metal detection system for pneumatic lines removes contaminants right at the start of the line on those conveyors producing items such as flour, sugar, or chocolate powder.

The Sesotec GENIUS GLS and C-SCAN GHF metal detectors configured for frozen meat blocks or bulk ingredient bags will find metal objects before they are broken, reduced in size, and damage machinery. Achieving Product Purity by managing foreign materials requires a robust preventative maintenance program for machinery. It demands enforcement of some common sense ideas, too, such as preventing risky materials like wood pallets and glass from entering the plant. It requires high GMP standards with attention to detail. Seemingly minor, but important, details include establishing rules such as no pens in shirt pockets, no jewelry, and mandatory hair nets worn below the ears. It also means the suppliers of ingredients have to be aware of your plant standards in this area.

The Way Forward

Achieving Product Purity is more than just HACCP compliance that relies on an end-of-the-line metal detector. It includes balancing risk versus cost.

It also requires a philosophical shift at some facilities. Simply put, the inspection system must be recognized as a piece of production machinery of equal status to the mixing or packaging machine. Just as the line will not run unless the packaging machine operates, the line must not run unless inspection systems operate safely and efficiently. A multi-prong inspection approach raises the chances of finding contaminants early. It can also help get to the root cause of a problem before it becomes a serious issue.

Strict regulation of the food industry is not going anywhere. In fact, FSMA provisions phasing in over the next five years are already beginning to change the landscape in a number of critical ways for food facilities.

New and tougher regulatory requirements are coming. However, the food industry cannot say it hasn‘t been warned. The real question now is what it decides to do next.