FSMA Consulting

FSMA Consulting

FDA & Food Safety Modernization Act

Each year, foodborne illness strikes approximately 48 million Americans (1 in 6), according to the Center for Disease Control (CDC). The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

FSMA Consulting and Training Services

Our PCQI credentialed consultants are Lead FSPCA Instructors with years of practical FDA-related experience. Our industry experts will assess where you are and clarify next steps to achieve FDA compliance. In fact, our plans have been reviewed and praised by the FDA. Based on your unique needs, and working closely with your team, we will:
  • Perform a FSMA Readiness Assessment
  • Prepare your FDA–compliant Food Safety Plan
  • Ensure your preventive controls are risk-based and effective
  • Develop a comprehensive Foreign Supplier Verification Program
  • Develop a robust Sanitary Transportation Program
  • Conduct a vulnerability assessment and develop your Food Defense Plan
  • Develop and implement proven strategies for Food Fraud Prevention
  • Facilitate client-dedicated FSMA Training at your location

Five Key Areas Of This Landmark Legislation:

  1. Preventive Controlsfor the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply to prevent or significantly minimize the likelihood of problems occurring.
  2. Inspection and Compliancethe legislation recognizes that inspection is an important means of holding industry accountable for its responsibility to produce safe food. FDA is committed to applying its inspection resources in a risk-based manner and adopting innovative inspection approaches.
  3. Imported Food SafetyFDA has new tools to ensure that imported foods meet U.S. standards and are safe for our consumers. For example, for the first time, importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety, and FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with U.S. food safety standards.
  4. Responsefor the first time, FDA has mandatory recall authority for all food products. FDA expects that it will only need to invoke this authority infrequently since the food industry largely honors our requests for voluntary recalls. This includes expanded administrative detention of products that are potentially in violation of the law, and suspension of a food facility’s registration.
  5. Enhanced Partnerships—the legislation recognizes the importance of strengthening existing collaboration among all food safety agencies—U.S. federal, state, local, territorial, tribal and foreign—to achieve our public health goals. For example, it directs FDA to improve training of state, local, territorial and tribal food safety officials.

The New Power of the FDA

  • Mandatory Recall Authority
  • Voluntary (no capability) to Mandatory (full capability)
  • Records Access
  • Very limited access historically to Full Access on any suspicion of non-compliance
  • Standards for Produce Safety
  • Greater definition/compliance to growing and handling of produce
  • Food Defense / Intentional Adulteration
  • Voluntary Food Defense Plan to a Required Food Defense Plan
  • Sanitary Transportation of Food
  • No focus on the movement of food materials to ESTABLISHED roles & responsibilities for all parts of the supply chain
  • Import of Food – Foreign Supplier Verification Program
  • No requirements to FULL compliance of Hazard Analysis by US manufacturers

The Seven FSMA Rules

  1. Preventive Controls for Human Food — the rules on preventive controls are intended to set safety requirements for facilities that process, package and store food.
  2. Preventive Controls for Animal Food — these rules are intended to better protect animal food and feed from contaminants.
  3. Produce Safety Rule — the Produce Safety Rule is intended to set new standards for growing, harvesting, packing and holding produce on domestic and foreign farms.
  4. Foreign Supplier Verification Program — the FSVP rule is intended to hold importers responsible for ensuring that foreign food suppliers meet the same public health standards required of U.S. food producers.
  5. Third Party Certification of Auditors for Foreign Suppliers — the third party certification program will establish a program for the accreditation of third-party auditors to inspect and evaluate foreign facilities and the foods they produce.
  6. Sanitary Transportation Rule — this rule will require the use of sanitary practices for transporting food.
  7. Intentional Adulteration Rule — the Intentional Adulteration Rule will require facilities to implement a food defense plan to prevent actions intended to cause public harm.