Which topics does the FSMA PSR add-on address?

FSMA is a comprehensive modification of the US food safety regulatory framework. One element of this, the PSR, establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. The FSMA PSR add-on was developed as an initiative of the National Technical Working Group USA, harnessing expertise from across the value chain to reduce the audit burden for producers whose production processes are already certified to the IFA standard.

Core topics in the FSMA PSR add-on v1.2 include:

• Worker qualification and training

• Biological soil amendments

• Growing, harvesting, packing, and holding activities

• Equipment, tools, buildings, and sanitation

• Records

• Agricultural water (preharvest)

• Agricultural water (harvest, postharvest water)

Discover how the FSMA PSR add-on helps you address challenges in the agricultural sector.

How does the FSMA PSR add-on work?

• Compliance with the add-on requirements is audited annually by an accredited and independent third-party CB together with the annual IFA audit (or an audit against a benchmarked scheme/checklist).

• Producers can choose from any GLOBALG.A.P. approved CB active in the relevant country – although the same CB which conducts the IFA audit must also conduct the FSMA PSR audit.

• A successful CB audit results in a letter of conformance valid for one year.

• The IFA and FSMA PSR add-on audit reports are provided to the producer to share with their supply chain as evidence of FSMA compliance.

The add-on is composed of principles and criteria (P&Cs). P&Cs are graded in two levels: Major Must and Recommendation.

Principless

• Fundamentals that set the foundation of a GLOBALG.A.P. requirement

• Written in statement form

• Describe the outcome to achieve in the corresponding criteria

Criteria

• Methods that producers can use to demonstrate a principle to be true

• Compliance can be demonstrated in different ways, e.g., data, record of procedure, etc.

• Evidence must demonstrate that the outcome is achieved

Read more about the audit process and add-on requirements.

How is conformance status verified?

Every producer registered in the GLOBALG.A.P. certification system is assigned a 13-digit GLOBALG.A.P. identification number (e.g., a GLOBALG.A.P. Number (GGN)). This number allows real-time verification of conformance status in the GLOBALG.A.P. IT systems, upholding our rigorous transparency requirements throughout the supply chain.

Producers can control data access and privacy rights for audit reports, and the reports are not shared publicly or with third parties. This process is handled via your chosen CB.

How do GLOBALG.A.P. solutions help meet FSMA requirements?

• FSMA contains nine rules to ensure a safe food supply in the US market. 

• The most relevant FSMA rules for fruit and vegetable production are the PSR, FSVP, and Preventive Controls for Human Food.

• The FDA requires importers to apply the PSR and Preventive Controls for Human Food to their suppliers through the FSVP.

• The IFA standard v5.4-1-GFS for fruit and vegetables with the FSMA PSR add-on v1.3 is officially recognized by the FDA, removing the need for importers to conduct an individual audit of each producer – saving both time and costs for supply chain stakeholders.

Alongside the FSMA PSR add-on, we offer two further solutions to support producers and supply chain stakeholders in meeting both FSMA requirements and market expectations for responsible farming practices. The Harmonized Produce Safety Standard (HPSS) and the Produce Handling Assurance (PHA) standard both support a streamlined audit and reporting experience.

Learn more about GLOBALG.A.P. smart farm assurance solutions related to FSMA compliance.

Which industry challenges does the FSMA PSR add-on address?

• According to the US Centers for Disease Control and Prevention, approximately 48 million people in the United States – one in six – suffer from foodborne illnesses each year.

• FSMA was introduced by the FDA to shift the attention from responding to food safety issues to preventing them, viewing the topic as not only a public health problem but also a threat to the long-term sustainability of the food supply chain.

• The FDA now requires all importers of fruit and vegetable products to the US market to apply the FSMA rules through the Foreign Supplier Verification Program (FSVP) – ensuring that these products meet consistent science-based standards for food safety, preventive controls, and more.

• In addition to other market demands on topics such as environmental sustainability and workers’ well-being, buyers are seeking a growing range of assurances, and producers are undergoing an increasing number of audits to satisfy them.

• The FSMA PSR add-on is designed to build on existing principles and criteria in the IFA standard and is audited at the same time, allowing both producers and buyers to demonstrate compliance while reducing audit fatigue in the supply chain.

Follow our five steps to the FSMA PSR add-on to get started today.

Which solutions can be combined with the FSMA PSR add-on?

The FSMA PSR add-on is designed to be paired with IFA certification for fruit and vegetables. Audits are conducted together with the IFA audit, allowing producers to extend their certification scope flexibly and efficiently through a single audit. The GLOBALG.A.P. portfolio also offers further solutions to address FSMA requirements for producers based in or exporting to the US market.

Learn more about GLOBALG.A.P. core solutions.

Implementation and CB audit process

How does the CB audit process work?

• Designed to complement existing Integrated Farm Assurance (IFA) certification, compliance with the FSMA PSR add-on requirements is audited annually together with the IFA audit by accredited and independent third-party CBs.

• Producers can choose from any GLOBALG.A.P. approved CB active in the relevant country – although the same CB which conducts the IFA audit must also conduct the FSMA PSR add-on audit.

• A successful CB audit results in a letter of conformance valid for one year.

• The CB is responsible for uploading the audit report and maintaining the accuracy of producer data in the GLOBALG.A.P. IT systems.

• Producers will be audited annually by a CB as part of the renewal process.

Which documents are required?

• FSMA PSR add-on general rules specifications: Rules that define how the audit process works, from the scope of the add-on to the audit requirements.

• Principles and criteria (P&Cs): Principles are the fundamental requirements for each add-on. They describe the outcome to achieve and are accompanied by corresponding criteria that detail the various ways in which a producer can demonstrate compliance.

• Checklist: The full list of add-on criteria as used by CB auditors, enabling producers to perform a self-assessment in preparation for the on-site audit.

Which versions of the FSMA PSR add-on are currently valid?

There are currently two valid versions of the FSMA PSR add-on.

• The FSMA PSR add-on v1.3 is designed to be paired with IFA v5.4-1-GFS for fruit and vegetables (recognized by GFSI). It was published on 7 September 2022 and became obligatory on 7 December 2022. This combination of IFA plus the FSMA PSR add-on remains available until GFSI recognition of IFA v6 GFS is achieved.

• The FSMA PSR add-on v2 was published on 28 August 2023. It becomes obligatory to combine with IFA v6 from 1 January 2024.

The FAQ contains more information on documents, the renewal process, and more.

How much does a FSMA PSR add-on audit cost?

Each farm is unique, and the total audit costs depend on a combination of factors such as farm size, number of sites, location, necessary preparation measures (such as establishing new procedures), and more. The FSMA PSR add-on contains three cost elements:

1. Implementation costs: Incurred by the producer to prepare for the CB audit

2. CB service fees: Determined and invoiced by the CB to cover audit time and travel costs

3. GLOBALG.A.P. registration and assessment license fee: See the GLOBALG.A.P. fee table for information on regional fees

The GLOBALG.A.P. fee table contains full information on the fee structure for each standard and add-on.