Food Safety Modernization Act, Self Assessments, and Guidance Tools

The Food Safety Modernization Act was signed into law in 2011 and the Food and Drug Administration (FDA) was charged with leading the implementation process. The Produce Safety Rule was prepared with input from the industry, and finalized in late 2015. The rule became effective on 26 January 2016. The FDA has prepared a website which contains guidance documents and the full text of the rule at:

GLOBALG.A.P. recommends that producers go directly to the FDA for their source of information and guidance whenever possible. FSMA compliance is frequently misinterpreted and stakeholders should rely on official information from federal agencies whenvener possible.

How GLOBALG.A.P. can help

Many synergies exist between the GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard for Fruit and Vegetables and the FSMA Produce Safety Rule. Recognizing the need to aid producers in understanding how FSMA compliance relates to the leading GLOBALG.A.P. IFA Standard, the GLOBALG.A.P. United Statues Crops National Technical Working group conducted a detailed comparative analysis of the GLOBALG.A.P. Integrated Farm Assurance Standard Version 5 against the Produce Safety Rule. The results showed that producers complying with the complete requirements of the GLOBALG.A.P. IFA Standard meet the majority of the Produce Safety Rule requirements, but some fundamental differences also exist. A guidance document was prepared to help growers understand where the FSMA Produce Safety Rule and the GLOBALG.A.P. are aligned, and were the differences are. A grower can complete the self-assessment to assist in compliance with FSMA.

It should be noted that this document does not replace knowledge of the FSMA Produce Safety Rule or guarantee compliance. GLOBALG.A.P. is not a regulatory agency, and the control points noted will not be included or scored with any official GLOBALG.A.P. Integrated Farm Assurance Fruit and Vegetable audit.

At this time, GLOBALG.A.P. has provided guidance documents in support of the Produce Safety Rule. Guidance documents in support of the Foreign Supplier Verification Program and the Good Manufacturing Practices Rule have not been developed by GLOBALG.A.P. and there are no immediate plans to do so, as these rules fall outside of the scope of GLOBALG.A.P.'s primary field-based farm assurance standards.

GLOBALG.A.P. is developing an Add-on to our Integrated Farm Assurance (IFA) Standard for Fruit & Vegetables that will complete our coverage of the FSMA Produce Safety Rule. The Add-on content is based on the FSMA User's Guide and Self-Assessment published in December 2016.  We have received overwhelming affirmation of the need for an auditable FSMA solution for producers in the USA and around the world with USA as a destination market.

Public Consultation

GLOBALG.A.P. now seeks public consultation from interested stakeholders.  We invite you to review the draft Control Points and Compliance Criteria, and the Add-on Rules available here until 13 March 2018.  Please focus your attention on the clarity of the questions and auditability of the points, since the requirements themselves are dictated by the FSMA Produce Safety Rule. It is foreseen that the final Add-on will be available from April/May 2018.

Third-parties will audit against the GLOBALG.A.P. FSMA Add-on to serve as evidence of FSMA implementation efforts at the farm level, in keeping with the current version of the FDA Produce Safety Rule (21 C.F.R. Part 112). When accompanied by the GLOBALG.A.P. Integrated Farm Assurance certification, the FSMA Add-on will aid producers in identifying FSMA requirements that must be addressed at the farm level. The Add-on and IFA certificate can be provided to retailers and value-chain participants as evidence of a producer’s efforts toward FSMA implementation. The Add-on 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.

Get more information

If you have additional questions about the FSMA Self-Assessment or would like more information about the commonalities and differences between the GLOBALG.A.P IFA Fruit & Vegetables and the FSMA Produce Safety Rule, please contact our North American office at: