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FSMA

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Food Safety Modernization Act & temperature monitoring

Today, the global food system poses many challenges. Goods from across the world are being imported and exported before entering distribution and becoming available to the public. Varying transportation times and ineffective temperature monitoring of products create a risk of spoilage and the spread of foodborne diseases.

In response, the U.S. Food and Drug Administration (FDA) established the FDA Food Safety Modernization Act (FSMA), which focuses on the sanitary — and monitored — transportation of food products. With FSMA’s passing, it’s become paramount for companies in the food industry to adapt their processes to achieve FSMA compliance.

Learn more about FSMA, as well as how to meet its standards, below.

 

What Is FSMA?

FSMA demonstrates a global movement to secure the quality of food, from farm to table. It’s one of seven foundational rules proposed by the U.S. government to establish a risk-based framework for food safety that meets the challenges of today’s modern world. The primary target of FSMA is to eliminate contamination during transportation.

By focusing on sanitary transportation, the FDA plans for FSMA to eliminate day-to-day practices that lead to food-safety risks, such as a failure to store food items at the appropriate temperature. If you’re familiar with the Sanitary Food Transportation Act (SFTA), you’ll find FSMA shares some of its qualities. The overarching goals of FSMA include to:

  • Improve public health: Decreasing foodborne illnesses is a critical goal of the FDA. To accomplish this task, it plans to develop prevention systems for shippers and members of their supply chain. It will also emphasize the importance of voluntary corrective action.
  • Optimize resources for a global food-safety network: Due to the encompassing nature of food shipments, which travel across state and international borders, the FDA intends to create a global food-safety network with partner agencies as well as state and local governments.
  • Use risk-based industry oversight: A global food-safety network offers a sophisticated and massive challenge, which is why the FDA will implement an expanded oversight toolkit that includes technical assistance to companies within the industry, as well as incentives for compliance, such as less frequent inspections.

 

Like other legislation, FSMA continues to adapt its statutes to address industry concerns or questions.

 

What Are the Standards of FSMA?

FSMA features an expansive list of requirements, from requesting the Centers for Disease Control and Prevention (CDC) to optimize their surveillance systems for foodborne illnesses by mandating food facilities to produce a preventative-controls plan. To narrow down the requirements of FSMA, consider its defining standards:

 

Prevention

Science-based, preventative controls are a significant requirement of FSMA and include the following:

  • Preventative-controls plan: Per FSMA, all food facilities must create a written preventative-controls plan. Your company’s strategy must assess any food-safety hazards, evaluate how to minimize or eliminate these risks and detail how your facility will ensure these controls are successful. You’ll also need to keep routine records for monitoring these hazards, plus inform inspectors of how you’ll handle problems.
  • Safety standards: For companies involved in the produce market, know that the FDA is still developing its safety standards for fruits and vegetables. Like its preventative controls, however, the goal is to find potential hazards. Another intention of these rules is to establish temperature controls and soil amendments, as well as packaging and hygiene standards.
  • Intentional contamination regulations: Another preventative mandate in development is for deliberate food contamination at vulnerable points throughout the supply chain, such as packaging and loading goods in a motor vehicle for transport. Other areas prone to spoilage include railways, as employees of the rail are often uninvolved in the inspection of products.

 

Inspection

To ensure the prevention of foodborne illnesses, the FDA will also conduct investigations to check for compliance. They will:

  • Inspect facilities: With FSMA’s passing, the FDA intends to evaluate domestic and foreign centers on a frequent basis. Operations labeled as “high-risk” will receive visits from inspectors more often — around every three years. As mentioned above, businesses that are “low-risk” can expect visits less often. Due to this system, it’s critical your company becomes compliant with FSMA.
  • Review records: Like many regulatory agencies, the FDA values documentation. That’s why FSMA requires comprehensive records documenting the manufacturing, shipping and distributing of goods. Safety plans, as well as standard operation procedures (SOPs), are also valued by inspectors. Requests to access your company’s records may occur during an inspection or inquiry from the FDA.
  • Examine food: According to FSMA, the FDA is permitted to test samples of your product. Accredited laboratories conduct the tests. It’s important to note that the FDA must still develop a program for certifying labs to ensure they match its quality standards for food distributed in the U.S.

 

Reaction

To ensure the proper response to food hazards, the FDA has developed the following reactions:

  • Recall: While many companies issue voluntary recalls when they discover a food-product contamination, others may decide not to release one. With FSMA, the FDA has been given the power of authority to submit mandatory recalls — they must, however, request that the company submits a recall voluntarily first.
  • Detain: With FSMA, the FDA is provided a more versatile standard for detaining food items that may violate FDA and FSMA regulations. While the FDA has used administrative detention for years, FSMA gives the regulatory body an expanded standard for assessing and detaining goods that may pose a risk.
  • Suspend: To encourage compliance and sanitary transportation, FSMA allows the FDA to suspend facilities from distributing their food products. If a company produces and distributes food with a reasonable chance of causing death or health issues, the FDA can suspend their registration.
  • Track: Many companies monitor the progress of their goods throughout the supply chain. The FDA wants to track domestic and imported items. It also wants to develop procedures for preventing a widespread outbreak of foodborne illnesses by tracing the end recipients of a food product.
  • Record: For facilities that manufacture, process, pack or store high-risk foods, the FDA is setting specific recordkeeping standards. While these measures are still in development, they will entail thorough details regarding the handling and production of these products.

 

Authorization

FSMA’s focus is on a global food-safety network, which is why the FDA has included standards for imported goods:

  • Accountability: Per FSMA, all importers must verify that their foreign suppliers produce food with preventative controls in place. If international suppliers deny the FDA access to inspect their facility, or the country denies FDA inspectors admission, the FDA can prohibit the importing of your goods. It can also require third-party certification for high-risk foods.
  • Certification: To expedite the process of importing goods, the FDA offers two programs — a voluntary program for importers and one for qualified third parties. The first requires that you work with a certified facility to receive faster processing times, while the other is for certifying that a foreign food facility meets U.S. standards for food safety, which allows it to import goods.

 

Collaboration

Due to the breadth of FSMA, the FDA partners with governments and agencies at every level, including:

  • State: Aiding the FDA in implementing FSMA requires an investment, which is why the legislation provides the FDA with a multi-year grant mechanism. Select state and local agencies can then receive a grant for assisting the FDA with things like inspections, record reviews and more.
  • Federal: Complying with FSMA’s inspection frequency requires the FDA to work with federal, as well as state and local agencies. FSMA also allows the FDA to create interagency agreements, providing multiple government bodies the opportunity to leverage their resources for inspecting seafood facilities.
  • Foreign: Creating a global food-safety network also asks the FDA to collaborate with foreign governments. The plan developed by the FDA focuses on a training plan for government bodies and members of their food industry to follow if they’re interested in importing goods to the U.S.

 

Prevent. Inspect. React. Authorize. Collaborate.

It’s a five-step process that the FDA is implementing with FSMA — and directly influences its requirements for shippers, carriers and many other parties in the supply chain of the food industry.

 

What Are the Requirements of FSMA?

With FSMA requirements, companies must focus on many of the standards discussed above. From developing preventable controls — as well as action plans in the event of contamination — to coordinating with supply-chain links, FSMA features a complete regulatory cycle. Phases of this cycle include:

 

Training

A critical component of sanitary transportation is knowledge. That’s why FSMA requires carrier personnel, which are people who physically move food by rail or motor vehicle in the U.S., to learn about sanitary transportation practices and potential contamination issues, as well as documentation practices for these items.

Carriers may be exempt from this rule, however. Depending on your carrier contract, you may be responsible for ensuring the sanitary conditions of transport vehicles. The only time your carrier holds this responsibility is when it’s agreed upon in the contract.

No matter which party is responsible, training must happen upon hiring. Documentation demonstrating that training took place must also be stored and made available to the FDA, or another government agency, upon request.

 

Transportation Operations

Transportation operations play a substantial role in FSMA compliance. They encompass all the preventative measures, from SOPs to training, that your facility takes to ensure the quality of your goods throughout the transportation process. Required preventative controls for transportation operations include:

  • Implementing temperature controls
  • Preventing cross-contamination of products
  • Prohibiting touching of ready-to-eat food items

 

It’s essential to note that these regulations apply to both human and animal food. In some instances, however, the FDA will permit the use of different transportation equipment — which is separate from transportation operations standards.

 

Vehicles and Transportation Equipment

Two vital factors in FSMA’s goal for sanitary transportation are vehicles and transportation equipment. Vehicles, which are either motor vehicles or railcars, and transportation equipment, which are either bulk or non-bulk containers, must meet a few requirements, including that they:

  • Provide clean and suitable conditions for food transport
  • Maintain sanitary conditions for protecting food items
  • Prevent contamination and the harboring of pests

 

If you ship temperature-sensitive goods, your vehicles and transportation equipment must provide temperature control measures to ensure your food items remain safe for consumption. In many cases, companies will use temperature data loggers to confirm temperatures stay stable.

 

Records

For many regulatory agencies, documentation is critical. Neither the FDA nor FSMA is an exception to this preference. Per FSMA, your team must maintain several types of original or electronic records, as well as store them for a set duration — storage periods do not exceed 12 months. Records mandated by the FDA include:

  • Written procedures
  • Shipment records
  • Contractual agreements
  • Training documentation

 

For written processes, it’s critical to note that you may need to develop three types of written practices. If you ship bulk items, for example, you will need to create SOPs that ensure the previous cargo doesn’t contaminate your newest shipment.

Though many of FSMA’s sanitary-transportation requirements are new, others — like recordkeeping — reference Title 21 of the Code of Federal Regulations (CFR). If you’re familiar with 21 CFR requirements, such as for electronic and digital signatures, it may be a more seamless process to comply with FSMA.

 

Who Is Exempt From FSMA?

Before diving into meeting the requirements of FSMA, it’s essential to highlight the numerous parties that are exempt from FSMA. While many companies within the food industry will find that they must adhere to FSMA, if you’re an air carrier, small- to medium-sized business or transhipper, you may not have to. FSMA applies to the following groups if they transport food in the U.S. by motor or rail vehicle:

  • Shippers
  • Receivers
  • Loaders
  • Carriers

 

If you’re a shipper based in Canada or Mexico and use motor or rail vehicles to deliver your food products to the U.S. market, you are also required to meet FSMA’s sanitary-transportation standards. Any country that ships food items to the U.S. and then distributes them to suppliers via rail or motor vehicle must also be FSMA compliant. Parties exempt from FSMA include:

  • Rail carriers: In early drafts of FSMA, rail carriers were required to meet FSMA standards. After receiving feedback, however, the FDA recognized that rail operators don’t often own, prepare or operate the rail cars they transport. Thus, shippers are now responsible for assessing their rail car unless a contract between the rail carrier and shipper shifts that responsibility.
  • Air carriers: Due to legislation limitations, FSMA does not regulate air carriers. That’s why countries that ship food by air to the U.S. for distribution only become accountable to the FSMA when moving their goods to a motor or rail vehicle. Even though airways are exempt from FSMA, it’s critical to ensure your air carriers provide a sanitary and secure cargo area for your goods to maintain their quality.
  • Ocean carriers: Like with air carriers, the FDA is unable to enforce its policies on ocean carriers as they travel between jurisdictions. The FDA’s move to establish a global food-safety network, as well as partner with foreign governments, may lead to FSMA applying to both ocean and air carriers. As with your air carriers, it’s essential to develop written protocols to secure the safety and edibility of your food items.
  • Transhippers: FSMA’s sanitary-transportation requirements do not apply to shipments that bypass U.S. distribution. Cargo from Mexico, for example, may travel by rail through the U.S. to reach its destination in Canada. A note to make about transshipments is that if your goods originate from the U.S., but are intended for export, FSMA standards apply until your shipment reaches a port or the U.S. border.

 

If your transport operations include select goods, such as the following, you can also bypass FSMA requirements:

  • Compressed gases for food or beverage products
  • Food contact substances
  • Human-food byproducts
  • Enclosed-food products
  • Live food animals

 

The FDA also offers FSMA waivers, per SFTA, to the following applicants:

  • Food establishments: Restaurants, retail food locations and nonprofit food establishments may all receive an exemption from the FDA. You must, however, have the authorization to operate these businesses from a regulatory authority. You’ll also need to meet certain transportation operations standards, such as delivering food directly to consumers. Your receivers must also transfer food shipments to your location immediately.
  • NCIMS-inspected companies: Businesses with a certification and up-to-date inspection from the National Conference on Interstate Milk Shipments (NCIMS) for their Grade “A” Milk Safety Program may request an FSMA wavier. Your transportation operations, however, must include bulk milk products — including Grade “A” ones.
  • NSSP-certified businesses: If your company carries an Interstate Shellfish Sanitation Conference’s National Shellfish Sanitation Program (NSSP) certification, you can receive an FSMA waiver. This waiver is only applicable if your transportation operations include molluscan shellfish and motor or rail vehicles approved by the NSSP.

 

If your food transportation operations, whether as a shipper, receiver or carrier, also have an annual revenue that’s below $500,000 — on average — you are also exempt from FSMA’s sanitary-transportation requirements.

 

How to Meet FSMA Standards

For many shippers, carriers, receivers and loaders, FSMA requirements are non-negotiable, which is why it’s critical to develop a plan for meeting these new FDA standards. By doing so, you not only avoid the potential fines of non-compliance but also prevent future losses due to contamination. To meet the sanitary-transportation regulations of FSMA, take the following steps:

 

Train Team Members

Training is a core goal of the FDA’s global food-safety network — which is one of the reasons it’s an FSMA requirement. It’s also why the FDA has partnered with the Produce Safety Alliance (PSA), Food Safety Preventative Controls Alliance (FSPCA) and Sprout Safety Alliance (SSA) to create a coalition of standardized training programs.

By funding these organizations, the FDA has created a platform for building approved training seminars. Third parties, such as the Association of Food and Drug Officials and the Association of State and Territorial Health Officials, host these training sessions, which include proof of participation.

Ensure your team, from loaders to receivers, attends one of these seminars on risk-based preventative controls, as well as basic sanitary-transportation standards. Depending on your agreement with your carrier, their team may also be required to undergo training. In such a case, request proof of their attendance for your records.

 

Establish Written Procedures

As a shipper, it’s essential that your team develops thorough, yet concise written procedures for your carriers and loaders to reference. If your company ships multiple types of food products, you will likely have to develop several write-ups for your contacts. When writing your protocols, note the following factors:

  • Temperature control
  • Shipment types
  • Sanitation standards
  • Cross-contamination controls

 

Before providing your carriers and loaders with your SOPs, test them beforehand. If your temperature-control protocol, for example, involves data loggers, evaluate and assess their accuracy and ease of use before giving them to your carrier. By taking this approach, you can modify your written procedures without losing goods.

 

Monitor Goods Throughout the Supply Chain

While the FSMA does not require temperature monitoring — only adequate temperature controls — many companies opt to track the condition of their food products in real time. If you’re working with a new carrier, this approach can often provide you with insight into their professionalism and adherence to your written protocols.

To ensure your food items are meeting their temperature requirements, use temperature data loggers. Many, like Emerald, feature Bluetooth® technology for hassle-free data collection. With these tools, data is uploaded to the cloud. Carriers may also access the information via a smartphone app, which lets them adjust conditions to prevent spoilage.

Outside of carriers, there are several other parties in the supply chain that benefit from temperature data loggers.

Production facilities and warehouses, for example, use wireless data loggers like the OCEASOFT Cobalt L3 to ensure goods are manufactured and stored at the appropriate temperature. The final links in the cold chain, such as supermarkets and restaurants, also rely on data loggers and their recordkeeping features to document their compliance with overseeing agencies, as well as the SOPs of suppliers.

With accurate temperature monitoring via data loggers, you can trust your company will meet FSMA’s transportation requirements for human and animal foods. You’ll also receive live feedback on your existing written procedures, which you may update afterward

 

Record Training, Temperature and Transportation

Documentation plays a critical role in complying with FSMA. Evaluate your existing documentation procedures and ensure you’re maintaining and storing vital records, such as your written protocols, data-logger data and contracts with members of your supply chain.

Other records you should maintain include:

  • Identification of potential hazards
  • Implementation of preventative controls
  • Documentation of compliance with local, state, federal and all other applicable regulations

 

If your company keeps electronic records and signatures, check your protocols for creating, editing and deleting these documents, as 21 CFR Part 11 likely applies to your operations. Make sure you also have quick access to these records and can deliver them to the FDA or another regulatory agency within two business days.

By taking the above steps, your company can ensure compliance with FSMA standards for sanitary transportation.

 

Secure Your FSMA Temperature-Monitoring Data Loggers

While not explicitly required by the FSMA, temperature-monitoring data loggers simplify the process of assessing the condition and status of your food products, which lets you react fast to changes in temperature or product quality, thus avoiding the potential setbacks of contaminated goods.

At OCEASOFT, our USB and Bluetooth® data loggers provide your company with not only accurate readings in real-time for some models but also compliance with FSMA’s standards for monitoring temperature during transportation operations, as well as production, distribution and sale processes. No matter the cold chain stage or facility type, from warehouses to retail facilities, temperature monitoring is critical to your company’s success.

 

Learn more about our FDA-compliant data loggers and ISO-certified company by contacting us today!