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US FSMA Compliance

The US Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) is considered the most sweeping reform of US food safety laws in more than 70 years. SGS Global FSMA Program Director Hank Karayan explores the first steps.

The US FDA Food Safety Modernization Act shifts the focus from responding to contamination to preventing it, and is based on seven foundational rules for compliance:

  1. Preventive Controls for Human Food
  2. Preventive Controls for Food for Animals
  3. Standards for Produce Safety
  4. Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
  5. Accredited Third-Party Certification
  6. Sanitary Transportation of Human and Animal Food
  7. Mitigation Strategies to Protect Food Against Intentional Adulteration

Preventive Controls for Human Food

The Preventive Controls for Human Food (PCHF) rule lays the foundation of preventive food safety in FSMA. It applies to domestic and foreign facilities that manufacture, process, pack, or hold human food.

There are modified requirements for certain “Qualified facilities” such as very small businesses or warehouses that solely engage in storage of unexposed packaged food. Seafood, juice, alcoholic beverages and dietary supplements are exempt from hazard analysis and preventive controls (but not GMP) provisions under the rule. All other entities are expected to comply with the full letter of the law.

Getting Started

One of the main questions most facilities ask about FSMA is how to take the first steps towards compliance.

External factors such as geography, food sector and country-specific regulatory requirements influence corporate food safety. However, one of the main internal factors in setting the first compliance steps is the maturity of the existing food system (including systems, preparedness, culture and awareness).

The food safety system in place will determine the required path to FSMA compliance. That’s because food safety in general has witnessed many phases in its evolution from Codex HACCP all the way to current revisions of international standards. At each phase, requirements were adjusted or added to address specific market, product, regulatory and stakeholder needs. In addition, subsequent scheme-specific requirements inject another variable into the formula, thus differentiating one scheme from the other and influencing the path to FSMA compliance.

In general, the more advanced the current management system is, the shorter the path to FSMA compliance. The way the company is positioned on the food safety evolution (or maturity) curve is therefore an indicator of the work required to achieve FSMA compliance.

While GFSI certification is a popular option, the majority of players in the global food supply chain supplying to the US have no GFSI certification. For these entities the food safety compliance scheme of choice remains HACCP, or a combination of HACCP with a management system either as two separate systems (e.g. HACCP & ISO 9001) or a combined system such as ISO 22000. In other cases, suppliers may have no formal food safety system in place except those required by specific clients and verified at client-imposed frequencies. However, as illustrated by Table 1, GFSI certification offers a closer fit to FSMA compliance.

Table 1 shows the maturity curve and the correlation between food safety systems and FSMA compliance for facilities covered by the regulation, with some scenarios.

Graph 1

Early Identification of Gaps

Once FSMA applicability criteria are established, the first step would be identifying gaps in the current system through self-assessment or third party gap analysis against FSMA requirements. This essential step also helps you evaluate the time, energy and resources needed to address any gaps in your system. 

Next, determine your training needs. Training is a critical success factor in FSMA implementation, and has been identified as a FSMA requirement. The regulation has PCQI (Preventive Controls Qualified Individual), QI (Qualified Individual), Auditors and Sanitary training requirements that must be considered.

Steps to FSMA Compliance

Graph 2

Foundation for Success

If you already have a food safety system in place, use it to build your food safety plan. The regulation may have specific terminology in place, but eventually you may want to reference documents from your existing system and include them in your Food Safety Plan.

While your existing food safety system will be of help in addressing FSMA requirements, it is important to note that with FSMA, there is a shift in philosophy when it comes to hazard analysis and food safety in general. Your critical control points (CCPs) would become process controls, but you would still need to address other process controls, food allergen preventive controls, sanitation and supply chain preventive controls. It is therefore recommended to complete a separate hazard analysis for FSMA and then determine the elements of your existing food safety system to reference (and include) in your food safety plan. This would be one of the main tasks to be undertaken by the facility PCQI along with the other functions specified under the rule.

Once you have your food safety plan ready for review, consider a gap assessment. This is an objective means of reviewing your food safety plan and verifying its implementation onsite. It would certainly be a valuable exercise in preparation for your FDA inspection. 

From conformance to compliance – FSMA has proven to be a game changer in food safety. While voluntary schemes help reduce the gap, FSMA compliance remains a requirement of its own for US and foreign companies covered by the regulation. Soon, foreign suppliers will also have the option of FSMA certification within the Voluntary Qualified Importer Program (VQIP), opening the door to new possibilities in food safety evolution.

SGS FSMA Services

Using a variety of tools and services SGS is a leader in FSMA compliance:

  • FSMA self-assessment by SGS is a complementary online tool for FSMA readiness. Start your self-assessment today
  • SGS offers FSMA PCQI and other FSMA-related courses through public, onsite and virtual classrooms. Check out the SGS training schedule
  • Gap assessment services for facilities and suppliers with or without existing certification, to help prepare for FDA inspection and FSMA certification.

SGS can meet all your audit, technical expertise, training and testing needs related to FSMA. 

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For the complete range of SGS services and support visit SGS Food Safety page.

For further information, please contact: 

Hank Karayan
Global FSMA Program Director 
t: +1 (514) 402-5810