FSMA

FSMA

FDA Food Safety Modernization Act

FDA Food Safety Modernization Act
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FDA Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA) is a significant change to US food safety legislation with the prevention of food contamination the key focus. The legislative changes impact both US domestic and foreign food facilities manufacturing human and animal foods to be consumed in the US.

All organizations across the world that export human or animal food to the US will need to comply with the expectations of the BSI Qualified Importer Program (QIP). The responsibility of confirming the requirements are met belongs to the US importer as they have the onus of sourcing safe food from the global food supply chain.

In addition to the requirements of the Foreign Supplier Verification Program, the importer may also participate in the BSI Third Party Program Certification (TPP) to facilitate the importation of foods from facilities that have been certified in accordance with FDA’s programme for Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and issue Certifications.

The FSMA (In compliance with the FDA requirements) accredited third-party certification voluntary program allows for the accreditation of third-party certification bodies and auditors to conduct food safety audits and issue certification of foreign food facilities and the foods they produce. This certification will be required for:

  • BSI Third Party Program Certification (TPP) to expedited review entry of imported foods
  • When a food offered for import is required to be accompanied by a certification from an accredited third-party certification body (mandated by the FDA)

How can BSI help?

BSI can support your organization through specialized training programs developed to help you meet FSMA (In compliance with the FDA requirements) for export to the US. These include:

  • BSI Qualified Imported Program (QIP) training to outline the specific requirements for food organizations to obtain FSMA (In compliance with the FDA requirements) certification.
  • Preventative Controls Qualified Individual (PCQI) training. This course will enable you to meet the requirements for a PCQI through the successful completion of training in the development and application of risk-based preventive controls recognized as adequate by FDA. Note that each facility must have a PCQI prepare or oversee the preparation of a food safety plan specific to that facility.

FSMA requirements and compliance timelines

Foreign food facilities required to register with section 415 of the Food, Drug and Cosmetic Act will need to comply with the requirements for risk-based preventive controls mandated by the FDA Food Safety Modernization Act (FSMA) and the modernized Current Good Manufacturing Practices (CGMPs). This requires a food facility to have a documented food safety plan, prepared by a Preventative Controls Qualified Individual (PCQI) with a comprehensive analysis of hazards and risk-based preventive controls to minimize or prevent the identified hazards unique to your product(s) and process(es).

The FSMA (In compliance with the FDA requirements) scopes of certification apply to:

Compulsory Module

  • Preventive Controls for Human Food (PC) (Part 117)

TPP (BSI Third Party Program Certification) Modules

  • Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption (Part 112)
  • Hazard Analysis and Critical Control Point (HACCP) Systems - Juice HACCP (Part 120)
  • Current Food Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food (Part 117)
  • Fish and Fishery Products - Seafood HACCP (Part 123)

BSI Qualified Importer Program (QIP) Modules

  • HACCP (Juice) (Part 120)
  • HACCP (Seafood) (Part 123)
  • Produce (Part 112) - except entities growing, harvesting packing or holding Almonds
  • Acidified Foods (Part 114)
  • Low Acid Canned Food (Part 113)
  • Infant Formula (Part 106)
  • Produce (Part 112)
  • Shell Eggs (Part 115, Part 118)
  • PC for Animal Food (Part 507)
  • Dietary Supplements (Part 111)

The FSMA (In compliance with the FDA requirements) scheme excludes:

  • Meat, Poultry, Breaking Eggs and Alcoholic Beverages
  • Entities growing, harvesting packing or holding Almonds of the Produce (Part 112) module.

FSMA (In compliance with the FDA requirements) compliance dates are staggered, based on the size of the business, with separate dates for the requirements of the supply chain program.

Why BSI?

BSI believes the world should be supplied with food that has been produced to an industry recognised food safety standard. We offer a broad range of food safety certification and risk management services to help all organizations in the food supply chain achieve compliance and industry best practice to grow their business.

We’re a leading food safety and certification provider with extensive auditing capacity and the capability to conduct integrated audits for a wide range of food safety standards across the entire food and beverage supply chain – including GFSI-recognized standards.

Our service solution for food safety includes certification, training, assessment and supply chain software, providing you and your customer’s assurance and enabling you to manage risk more effectively.