Food Safety Modernization Act

In the USA, the Food and Drug Administration (FDA) Food Safety and Modernization Act (FSMA) requires specific practices to be implemented and followed for the production, handling, and import of food products. The FDA maintains a website which contains FSMA rules, guidance documents, compliance dates and other resources. 

GLOBALG.A.P. recommends that producers go directly to the FDA for their source of information and guidance whenever possible. 

How GLOBALG.A.P. can help

Although the FDA does not yet formally recognize private schemes for their coverage of FSMA, GLOBALG.A.P. aims to support its stakeholders with meeting FSMA requirements as well as market expectations for GAP through a single audit experience.

GLOBALG.A.P. FSMA Produce Safety Rule Add-on

GLOBALG.A.P. stakeholders request an auditable FSMA solution for producers in the USA and around the world with USA as a destination market. Producers complying with the complete requirements of the GLOBALG.A.P. IFA FV Standard meet the majority of the FSMA Produce Safety Rule (PSR) requirements. To support implementation efforts at the producer level, GLOBALG.A.P. offers its FSMA Produce Safety Rule Add-on to address control points found in the FSMA PSR that are not explicitly covered by IFA. The Add-on may be used by producers growing fruit and vegetables in the Unites States, as well as producers outside the United States who anticipate their products will be exported to the US market. 

  • The FSMA PSR Add-on is designed to be paired with the GLOBALG.A.P. Integrated Farm Assurance Fruit and Vegetables Standard (IFA FV).
  • The control points found in the FSMA PSR Add-on are reviewed by a third party during the annual GLOBALG.A.P. certification inspection.
  • When accompanied by IFA FV certification, the FSMA PSR Add-on will aid producers in identifying FSMA requirements that must be addressed at the farm level.
  • The FSMA PSR Add-on plus IFA FV certificates can be provided to retailers and other value-chain participants as evidence of a producer’s efforts toward FSMA implementation.  
  • "FSMA Observers" have access to Audit reports, Non-Conformity Summaries and Corrective Action Reports in the GLOBALG.A.P. database.
  • As the FDA is still reviewing elements of the FSMA PSR addressing water quality, the GLOBALG.A.P. FSMA PSR Add-on will not require conformance with FSMA-specific water quality control points.
  • The FSMA PSR Add-on certificate is not an assurance or guarantee of FSMA compliance, as legal compliance can only be determined by a regulatory authority, such as the FDA.

Harmonized Produce Safety Standard (HPSS)

The GLOBALG.A.P. HPSS is a GFSI-recognized food safety standard designed to serve the needs of the United States fruit and vegetable producers, and those selling into the United States market.  The HPSS includes verbatim the  Produce GAP Harmonization Initiative's Harmonized Standards. The Initiative's Technical Committee compared its Harmonized Standards to the FSMA Produce Safety Rule and completed an update to cover the Produce Safety Rule’s requirements in the Harmonized Standards v1.1.  In turn, GLOBALG.A.P. updated HPSS to v1.1 to mirror these changes.

  • The HPSS v1.1 will aid producers in identifying FSMA requirements that must be addressed at the farm level. 
  • The HPSS v1.1 certificate can be provided to retailers and other value-chain participants as evidence of third-party verified producer’s efforts toward FSMA implementation. 
  • The HPSS v1.1 certificate is not an assurance or guarantee of FSMA compliance, as legal compliance can only be determined by a regulatory authority, such as the United States Food and Drug Administration.

Learn more about HPSS. 

Produce Handling Assurance Standard (PHA)

The GLOBALG.A.P. Produce Handling Assurance Standard (PHA) covers pre-process production steps after the point of harvest for crops including cooling, packing, re-packing, handling, and storage of produce for human consumption. Like the FSMA PSR Add-on, the PHA is designed to provide an auditable FSMA solution for packing operations in the USA and around the world with USA as a destination market.  FSMA requirements from both the Produce Safety Rule and Preventive Controls for Human Food Rule are included as applicable.

  • PHA will aid operations in identifying FSMA requirements that must be addressed in pre-processing.
  • The PHA certificate can be provided to retailers and other value-chain participants as evidence of a supplier’s efforts toward FSMA implementation. 
  • "FSMA Observers" have access to Audit reports, Non-Conformity Summaries and Corrective Action Reports in the GLOBALG.A.P. database.
  • The PHA certificate is not an assurance or guarantee of FSMA compliance, as legal compliance can only be determined by a regulatory authority, such as the FDA.

Learn more about PHA. 

Get more information 

If you have additional questions about how GLOBALG.A.P. can support FSMA needs, please contact our North American office at: northamerica-technical@globalgap.org

                 

 

Quicklinks

Harmonized Produce Safety Standard  (HPSS)

Produce Handling Assurance Standard (PHA)

Downloads

FSMA Add-on training - Presentation

FSMA PSR Add-on training for CBs 19 April 2018 -  Recording

FSMA PSR Add-on training for Farm Assurers 23 April 2018 - Recording

FSMA Flyer English (220 KB) Spanish (230 KB)