Add-on to core solution
Food Safety Modernization Act Produce Safety Rule add-on
The Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR) add-on aims to address the specific requirements of the US Food and Drug Administration (FDA) for the production, handling, and storage of fruit and vegetable products. It is applicable globally for producers exporting to the US market and has been officially recognized by the FDA.
Facilitating regulatory compliance in global supply chains
What is the Food Safety Modernization Act Produce Safety Rule add-on?
The Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR) add-on helps producers to implement the specific requirements of the US Food and Drug Administration (FDA) PSR at farm level. Relating to the production, handling, and storage of fruit and vegetable products destined for the US market, the add-on prepares exporters and assures importers by supporting compliance with the Foreign Supplier Verification Program (FSVP). Designed to be paired with the Integrated Farm Assurance (IFA) standard for fruit and vegetables, the FSMA PSR add-on is tried, tested, and trusted around the world – with over 3,700 producers in more than 15 countries already audited.
FSMA PSR add-on at a glance
Formally recognized
following participation in the FDA’s voluntary pilot program to evaluate third-party food safety standards
Covers the PSR requirements
for fruit and vegetable producers supplying the US market
Offers cost-efficient audits
for a wide range of fruit and vegetable farm sizes and types, including smallholders and producer groups
Delivers credible verification
of producer conformance, including an audit report issued by a GLOBALG.A.P. approved CB
Assures importers
that their international suppliers meet the verification requirements of the FSVP
Audited together
with IFA for fruit and vegetables to minimize the audit burden for producers
Formally recognized
following participation in the FDA’s voluntary pilot program to evaluate third-party food safety standards
Covers the PSR requirements
for fruit and vegetable producers supplying the US market
Offers cost-efficient audits
for a wide range of fruit and vegetable farm sizes and types, including smallholders and producer groups
Delivers credible verification
of producer conformance, including an audit report issued by a GLOBALG.A.P. approved CB
Assures importers
that their international suppliers meet the verification requirements of the FSVP
Audited together
with IFA for fruit and vegetables to minimize the audit burden for producers
Formally recognized
following participation in the FDA’s voluntary pilot program to evaluate third-party food safety standards
Covers the PSR requirements
for fruit and vegetable producers supplying the US market
Offers cost-efficient audits
for a wide range of fruit and vegetable farm sizes and types, including smallholders and producer groups
Delivers credible verification
of producer conformance, including an audit report issued by a GLOBALG.A.P. approved CB
Assures importers
that their international suppliers meet the verification requirements of the FSVP
Audited together
with IFA for fruit and vegetables to minimize the audit burden for producers
Formally recognized
following participation in the FDA’s voluntary pilot program to evaluate third-party food safety standards
Delivers credible verification
of producer conformance, including an audit report issued by a GLOBALG.A.P. approved CB
Covers the PSR requirements
for fruit and vegetable producers supplying the US market
Assures importers
that their international suppliers meet the verification requirements of the FSVP
Offers cost-efficient audits
for a wide range of fruit and vegetable farm sizes and types, including smallholders and producer groups
Audited together
with IFA for fruit and vegetables to minimize the audit burden for producers
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 v2.1 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)
Please note that the FDA published revised agricultural water requirements on 5 May 2024. The new requirements are effective as of 5 July 2024, and enforced as early as 7 April 2025 for the majority of producers. The FSMA PSR add-on v2.1 has been updated accordingly to ensure coverage of the revised requirements.
Discover how the FSMA PSR add-on helps you address challenges in the agricultural sector.
Who should use the FSMA PSR add-on?
The FSMA PSR add-on is applicable globally to fruit and vegetable producers who supply the US market.
The add-on offers cost-efficient audit options for both individual producers (single site and multisite producers) and producer groups, including smallholders. Producers can get audited in any country where a GLOBALG.A.P. approved certification body (CB) conducts audits.
The add-on must be paired with IFA for fruit and vegetables.
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 was officially recognized by the FDA in July 2023 as aligned with the technical requirements of the FSMA PSR – removing the need for importers to conduct an individual audit of each producer – and saving both time and costs for supply chain stakeholders.
The new versions of IFA v6 GFS plus the FSMA PSR add-on v2.1 include all of the requirements reviewed in the pilot program to ensure continued coverage.
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. 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.
Latest news
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The GGN label is a transparent, cross-category consumer label that highlights certified, responsible practices in agriculture, aquaculture, and floriculture. Find out how it can add value to your products and business.
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Technical news updates for all add-ons can be found in our technical news libraries.
Simplify the path to Food Safety Modernization Act compliance
Why choose the Food Safety Modernization Act Produce Safety Rule add-on?
Developed in collaboration with supply chain stakeholders, the Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR) add-on bridges the gap between FSMA PSR requirements and the existing food safety criteria of the Integrated Farm Assurance (IFA) standard for fruit and vegetables. Combined with IFA, the FSMA PSR add-on, as officially recognized by the US Food and Drug Administration (FDA), supports a streamlined audit process and expedites regulatory inspections for importers – providing a practical and cost-effective path for producers to demonstrate 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 the environment and workers’ health, safety, and welfare, 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.
FSMA PSR add-on in numbers (as of 31/12/2023)
3,748
producers audited to the add-on
16
countries with audited production processes
384,270
hectares of audited production
3,748
producers audited to the add-on
16
countries with audited production processes
384,270
hectares of audited production
3,748
producers audited to the add-on
16
countries with audited production processes
384,270
hectares of audited production
3,748
producers audited to the add-on
16
countries with audited production processes
384,270
hectares of audited production
What are the benefits for producers?
Covers the FSMA PSR requirements for both US-based and international producers who supply fruit and vegetables to the US market.
Supports efficiency, with the combination of IFA and the add-on recognized by the FDA and audited together annually.
Delivers credible verification of efforts toward PSR implementation through a letter of conformance and audit report issued by an independent, third-party GLOBALG.A.P. approved certification body (CB).
Benefit from transparency through real-time conformance verification in the GLOBALG.A.P. IT systems.
Apply our farm assurance solutions on a wide range of farm types and sizes, and access certification options for both individual producers and producer groups.
What are the benefits for supply chain stakeholders?
Officially FDA-recognized, following GLOBALG.A.P. participation in the FDA’s voluntary pilot program to evaluate third-party food safety standards.
Provides importers with complete coverage of the PSR requirements for the FSVP.
Source from a growing pool of global suppliers with FSMA-compliant production processes.
Benefit from transparent, real-time online verification of a producer’s conformance status, including audit reports, in the GLOBALG.A.P. IT systems.
Choose from a flexible portfolio of farm assurance solutions that provides all the coverage you need through one certification system – including other solutions targeted at FSMA compliance.
Maintaining trust in GLOBALG.A.P. certification
The GLOBALG.A.P. Integrity Program was founded in 2008 as the first of its kind in food certification. Designed to ensure the consistent delivery and implementation of GLOBALG.A.P. standards and add-ons worldwide, the program monitors and assesses all aspects of the third-party certification process.
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.
You may also be interested in...
Integrated Farm Assurance for fruit and vegetables
IFA is a global standard that aims to promote safer and more responsible farming practices in fruit and vegetable production.
Harmonized Produce Safety Standard
HPSS is a GFSI-recognized, FSMA-aligned food safety standard based on the Combined Harmonized Standard from the IFPA’s Produce GAP Harmonization Initiative.
Produce Handling Assurance
PHA is a GFSI-recognized, FSMA-aligned food safety and traceability standard for postharvest activities such as the packing, handling, and storage of crops.
Ready to get started?
Use our Smart Checklist Builder to easily understand which GLOBALG.A.P. smart farm assurance solutions are recommended for your production practices and generate a personalized checklist for your self-assessment.
Your guide to implementation
How to prepare for a Food Safety Modernization Act Produce Safety Rule add-on audit
Learn more about the key documents and fee structure of the Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR) add-on. Follow our five steps to the FSMA PSR add-on for an overview of the audit process, and find a GLOBALG.A.P. approved certification body (CB) in your area to get started.
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 version of the FSMA PSR add-on.
The FSMA PSR add-on v2.1 was published on 7 January 2025. It must be combined with IFA v6.
The FSMA PSR add-on v2 was published on 28 August 2023, and will be replaced by v2.1 on 7 April 2025.
The FAQ contains more information on documents, the renewal process, and more.
What are the FSMA PSR add-on requirements?
P&Cs are graded in two levels: Major Must and Recommendation.
To pass a CB audit, producers must comply with 100% of the Major Musts.
Corrective actions must be proposed for all non-compliances and submitted to the CB within the specified period.
Non-compliances must then be verified as corrected and compliant by the CB before a letter of conformance can be issued.
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:
Implementation costs: Incurred by the producer to prepare for the CB audit
CB service fees: Determined and invoiced by the CB to cover audit time and travel costs
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.
Five steps to the FSMA PSR add-on
You will need the FSMA PSR add-on general rules specifications, the FSMA PSR add-on P&Cs, and the checklist. All of the required documents are available online, for free, and in multiple languages. They are linked below and can also be found in the GLOBALG.A.P. document center.
Use the documents to guide the implementation of the add-on requirements, and then
conduct a self-assessment using the checklist. Our worldwide network of Registered Trainers
can also provide assistance during audit preparations.
Search the list of GLOBALG.A.P. approved CBs by region, country, scope, and status. Contact the CB of your choice and request an audit. Note that the GLOBALG.A.P. fee table does not cover CB service fees such as audit time or travel costs to your site.
The CB will perform the on-site audit and upload the results to Audit Online Hub. Any non-compliances which are detected during the audit must be corrected within the specified period and verified by the CB before a letter of conformance can be issued.
Once all requirements are met and verified by the CB, they will issue your FSMA PSR add-on letter of conformance. Your conformance status is then publicly visible in the GLOBALG.A.P. IT systems for transparency in the market.
Key documents
The three most relevant documents are linked below. Click ‘view more’ to see further related documents. Remember to always check with your CB that you have all necessary documents prior to audit.
FSMA PSR add-on specifications
Rules and regulations
V2.1
English | Last updated: 10/02/2025
Rules and regulations
V2.1
English | Last updated: 10/02/2025
Rules and regulations define how a specific standard must be implemented – from the certification scope to the audit requirements for certification bodies.
FSMA PSR add-on for fruit and vegetables
Guidelines and supporting documents
V2.1
English | Last updated: 10/02/2025
Guidelines and supporting documents
V2.1
English | Last updated: 10/02/2025
Guidelines and supporting documents are developed by the GLOBALG.A.P. Secretariat to help producers understand the terminology, legal requirements, and farm-level implementation of GLOBALG.A.P. standards and add-ons.
FSMA PSR add-on
Principles and criteria (P&Cs) (CPCCs)
V2.1
English | Last updated: 07/01/2025
Principles and criteria (P&Cs) (CPCCs)
V2.1
English | Last updated: 07/01/2025
Principles and criteria are a complete list of the requirements for a given standard or add-on. The foundational requirements each detail an outcome that must be achieved, and the corresponding ways in which compliance can be demonstrated.
GLOBALG.A.P. approved CBs
The list of GLOBALG.A.P. approved CBs can be filtered by region, country, scope, and status. Click a CB to find more information and contact details.
If you do not filter your search, or filter only according to region and/or country, your search results will also show CBs that offer certification against benchmarked schemes, but which may not have approval for any GLOBALG.A.P. standards and add-ons.
Capacity building
Need assistance with the certification process? Our capacity-building program offers a range of options for training, consultation, and more!
Upcoming events
24 Apr
2025
GLOBALG.A.P. and Stronger Together present free webinar
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Event format: Virtual
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2025
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Event format: On-site
A brief history of the FSMA PSR add-on
The creation of the add-on is initiated by the National Technical Working Group USA in 2018. Initially planned as a self-assessment for producers, the add-on is developed and trialed with support of a dedicated focus group including participants from producers, CBs, supply chain stakeholders, and retailers.
The FSMA PSR add-on v1 launches, bridging the gap between the requirements in IFA for fruit and vegetables and those of the PSR. Over 100 producers in six countries achieve a certificate of conformance in this first year.
A first update incorporating stakeholder feedback after the first year of implementation – FSMA PSR add-on v1.1 – is published in February 2019, replacing v1 in May. Later that year, a v1.2 update is published in November.
The FSMA PSR add-on v1.2 replaces v1.1 from February 2020. There are now over 2,200 producers with production processes audited to the FSMA PSR add-on – a 73% increase on the previous year. The add-on is implemented in 14 different countries.
In October 2020, the US Food and Drug Administration (FDA) launches the “Voluntary Pilot Program to Evaluate Alignment of Third-Party Food Safety Standards with FSMA Rules.” Assessing the alignment of private standards with the requirements in the PSR and Preventive Controls for Human Food, the FDA selects IFA v5.4-1-GFS plus the FSMA PSR add-on v1.2 to take part in the pilot program.
Following review by an FDA technical expert as part of the ongoing pilot program, any inconsistencies of IFA v5.4-1-GFS plus the FSMA PSR add-on v1.2 are discussed and resolved, resulting in the development of v1.3. By the end of 2021, over 3,050 producers’ production processes are audited to the FSMA PSR add-on across 15 countries.
The revised v1.3 is submitted to the FDA and then published in September 2022, replacing v1.2 in December. Development also begins on the FSMA PSR add-on v2 to bring it in line with the new smart approach of IFA v6 (launched in April 2022).
In July 2023, the FDA formally recognizes IFA v5.4-1-GFS plus the FSMA PSR add-on v1.3, marking a major milestone for the add-on. In August, the FSMA PSR add-on v2 is published.
In January 2025, the add-on is updated to v2.1 to include the revised agricultural water requirements of the FDA.
FAQ
The FSMA PSR add-on version 2.1 was published on 7 January 2025, and will replace v2 from 7 April 2025. It must be combined with IFA v6.
There is no GLOBALG.A.P. assessment license fee for producers based in the United States or Canada.
For producers based elsewhere, each farm is unique and the total cost of the audit depends on a combination of factors (such as size, location, existing policies and processes, etc.). The invoice from your certification body (CB) will include CB service fees to cover expenditures (determined by the CB) and the GLOBALG.A.P. assessment license fee.
Download the GLOBALG.A.P. fee table to learn more.
FSMA PSR add-on documents are currently available in:
English
Spanish
All documents are located in the GLOBALG.A.P. document center. More languages are added based on demand – please contact us with requests.
Compliance with the FSMA PSR add-on requirements is audited annually. The certification body (CB) audit must take place within the validity period of the current certificate of conformance in order for your production processes to retain the conformance status. Contact your CB to request an audit.
When developing our standards and add-ons, we aim to receive as much input and feedback as possible. With producers based in more than 135 countries around the world and stakeholders covering every part of the value chain, our standard-setting process ensures that our solutions are both fit for purpose now and built with the future in mind.
The FSMA PSR add-on is updated in response to changing regulatory requirements, interpretation, and/or GLOBALG.A.P. Integrated Farm Assurance (IFA) standard changes to ensure that the add-on meets market and regulatory expectations.
Revisions to the add-on are generally reviewed by the National Technical Working Group USA and an open FSMA PSR Add-on Focus Group. Participation in these groups is voluntary and not limited to any affiliation, role, region, or GLOBALG.A.P. Community Membership status. This helps to uphold transparency in the development and decision-making process.
Technical questions can be addressed to standard_support@globalgap.org. Your query will be forwarded to the relevant technical expert.
The GLOBALG.A.P. Academy offers public trainings on our portfolio of smart farm assurance solutions, while our worldwide network of Registered Trainers offers authorized trainings and other services. See the GLOBALG.A.P. Academy course catalog or find a Registered Trainer for more information.
The CB auditor requirements for the FSMA PSR add-on are detailed in the “GLOBALG.A.P. FSMA PSR add-on general rules specifications”.
Learn more about how to become a GLOBALG.A.P. approved CB or extend your auditing scope.
No, certification to a GLOBALG.A.P. standard/holding a GLOBALG.A.P. certificate is not the same as being a GLOBALG.A.P. Community Member.
GLOBALG.A.P. Community Membership is a paid partnership opportunity, offering a variety of benefits including the ability to support the development of GLOBALG.A.P. standards and add-ons, contribute to the GLOBALG.A.P. governance structure, and access discounted services.
Learn more about how to become a GLOBALG.A.P. Community Member.
GLOBALG.A.P. trademarks may be used in a strictly B2B context and must be accompanied by a GLOBALG.A.P. identification number (e.g., the producer’s GLOBALG.A.P. Number (GGN)) or a QR code to a producer’s conformance status in the GLOBALG.A.P. IT systems. The trademarks should never appear to consumers, for example on product packaging.
Download the GLOBALG.A.P. trademarks use: policy and guidelines and GLOBALG.A.P. trademarks use: FAQ documents for comprehensive information on rules and use cases.
Questions about FSMA?
See our dedicated FAQ for information on FSMA rules for the fresh produce industry, including producers, postharvest facilities, importers, and certification bodies.
Contact us
For technical/interpretation questions, please contact us at standard_support@globalgap.org.
For questions about the audit process or GLOBALG.A.P. IT platform, please contact us at customer_support@globalgap.org.