Food Safety Modernization Act FAQ

Fruit and vegetable producers who are either based in or export to the United States must meet the requirements for the growing, harvesting, packing, and holding of produce for human consumption contained in the Produce Safety Rule (PSR). Produce currently exempt from the PSR can be found on the FDA website.

The PSR key requirements include:

• Agricultural water

• Biological soil amendments

• Domesticated and wild animals

• Worker training, health and hygiene

• Equipment

• Tools and buildings

• Recordkeeping

On 2 December 2022, the FDA published the FSMA Proposed Rule on Agricultural Water, removing agricultural water (preharvest) testing requirements and inserting preharvest water risk assessment requirements. Currently, the GLOBALG.A.P. FSMA PSR add-on does not require conformance with FSMA PSR-specific microbial water quality criteria for preharvest water. However, these requirements were included as unscored recommendations and will be removed from the FSMA PSR add-on control points and compliance criteria if and when the final rule is published. Agricultural water requirement compliance dates for the previous rule started January 2022, however the FDA has determined that they will offer “enforcement discretion” clarifying that producers should focus on the requirements in the proposed rule.

• Very small businesses, those with more than $25,000 but no more than $250,000 in average annual produce sales during the previous three-year period: 27 January 2020

• Small businesses, those with more than $250,000 but no more than $500,000 in average annual produce sales during the previous three-year period: 28 January 2019

• All other farms: 26 January 2018

The compliance dates for certain aspects of the water quality standards, and related testing and recordkeeping provisions, allow an additional two years beyond each of these compliance dates for the rest of the final rule.

Latest information for compliance dates should be reviewed on the FDA website.

The combination of IFA v5.4-1-GFS for fruit and vegetables plus the FSMA PSR add-on v1.3 is recognized by the FDA as being in alignment with the existing requirements of the PSR.

At the time of review, the applicability of PSR Subpart E, related to Agricultural Water, was under reconsideration for produce, and was not included in the review for alignment. At the conclusion of the pilot, FDA did not plan to review additional standards or versions. IFA v6 GFS plus the FSMA PSR add-on v2 include all of the PSR requirements reviewed in the alignment pilot to ensure continued coverage.

Audits conducted against GLOBALG.A.P. standards and add-ons are not a substitute for FDA or state regulatory inspections of compliance with FDA regulations. Please refer to the FDA website for more details.

The GLOBALG.A.P. Harmonized Produce Safety Standard (HPSS) is a food safety standard that includes the International Fresh Produce Association (IFPA) Produce GAP Harmonization Initiative’s Combined Harmonized Standard. It also contains additional content that is necessary to achieve certification recognized by the Global Food Safety Initiative (GFSI).

The FDA released a statement in 2018 stating that the US Department of Agriculture’s Harmonized Good Agricultural Practices Audit Program (H-GAP) is aligned with the PSR. As this is formed of the same Combined Harmonized Standard that is included in full in HPSS, there is reasonable assurance that HPSS is also aligned.

The PSR requires that “at least one supervisor or responsible party for your farm must have successfully completed food safety training at least equivalent to that received under standardized curriculum recognized as adequate by the Food and Drug Administration (112.22c).” The Produce Safety Alliance (PSA) Grower Training course is one way to satisfy the PSR requirement for supervisor training.

The GLOBALG.A.P. Secretariat has coordinated with PSA lead trainers to offer this course in Mexico, Latin America, South Africa, and elsewhere as needed by our stakeholders. The dates and registration for these trainings are available in the GLOBALG.A.P. Academy course catalog.

When a producer has achieved a letter of conformance for the FSMA PSR add-on, the public will be able to see basic information including producer name, audit status, GLOBALG.A.P. identification number (GGN), city, and country in the GLOBALG.A.P. database.

The audit reports are not visible to the public. By default, the letter of conformance and report will not be visible to anyone except the certification body (CB) and the GLOBALG.A.P. Secretariat.  The CB must send the completed reports to the letter of conformance holder, who may then share it with importers and buyers directly.

A product handling unit (PHU) facility may be required to follow the PSR or the Preventive Control for Human Food (PCHF) Rule, depending on whether the facility fits under the definition of “farm” or “food facility”.

The definitions include varying examples of the percentage of a producer's product that is handled, and the activities undertaken at the facility. However, the FDA currently is enforcing "discretion" on produce PHUs – meaning that PHUs with raw agricultural commodities are currently being inspected under the PSR until the FDA further updates the PSR to include PHUs that handle, but do not process, raw fruits and vegetables.

The PHUs must still comply with the current Good Manufacturing Practices (cGMP) requirements of both the PSR and the PCHF.

Parallel ownership (PO) is not possible in the FSMA PSR add-on.

The producer can decide to include all or only one of the products originating from IFA-certified production processes. However, if the FSMA PSR add-on letter of conformance includes a product, it must include all of the area for that crop produced under the IFA-certified production processes.

For example, a producer has IFA-certified production processes for both tomatoes and lettuce. The producer can include tomatoes produced under production processes audited to the FSMA PSR add-on, but exclude lettuce that is also produced under IFA-certified production processes.

Therefore, if the FSMA PSR add-on letter of conformance includes tomatoes, it must include all tomatoes that are produced under the IFA-certified production processes for tomatoes.

The CB audit for the FSMA PSR add-on must be conducted in combination with the IFA for fruit and vegetables audit. However, understanding that buying contracts may develop over a certification cycle, the GLOBALG.A.P. Secretariat allows CBs to add the FSMA PSR add-on during the certification cycle.

To do so, the CB must conduct a full IFA audit with the FSMA PSR add-on audit. The CB may use the existing IFA audit report and record only new information in order to simplify the process. This option is only available to producers already holding IFA certification and seeking their first FSMA PSR add-on letter of conformance, during an on-site audit that occurs after the IFA certification or re-certification audit and before the next scheduled annual audit.

All add-on letters of conformance must not exceed the IFA certificate expiry date, and therefore the letter of conformance for the FSMA PSR add-on will be less than one year. Remote auditing is only available with non-GFSI recognized versions of IFA, and only possible in emergency situations.

The duration depends on the complexity of activities and the size of the area under certification, among other factors. The minimum audit planning guideline for certification bodies is one hour per site.

In the principles and criteria and general rules specifications, with the exception of the fee tables, “covered” means the product is included in the PSR and therefore included in the FSMA PSR add-on, just as the FDA uses the term in the PSR.

The “covered” area registered under the FSMA PSR add-on letter of conformance must be the same as the area registered/certified for Integrated Farm Assurance (IFA) for each product “covered” by the FSMA PSR add-on.

However, to determine the applicable fees, the fee table indicates that “covered” means the traditional GLOBALG.A.P. definition of the term. For example, products grown in a greenhouse or other permanent structure must use the “covered” fee table and those grown in an open field must use the “non-covered” fee table for all areas included in the FSMA PSR add-on.

For Option 2 producer groups where the certificate holder wishes to obtain a FSMA PSR add-on letter of conformance, all IFA-certified producers for the selected product(s) are required to be audited against the FSMA PSR add-on.

Parallel ownership (PO) is not allowed within the FSMA PSR add-on. However, if an Option 2 group (or multisite with QMS) has already registered for PO, then all IFA-certified production processes for the selected products must be included in the FSMA PSR add-on.

The certificate annex, report, and certification body (CB)/internal register must reflect actual producers included in the add-on. The sample of external producer inspections shall include producers registered for the add-on. The internal inspection must include an internal audit of the add-on for each producer registered to the add-on, and the CB auditor must review the add-on audit reports during the quality management system (QMS) audit.

Additionally, the CB shall check that the QMS internal inspector and auditor maintain FSMA PSR qualifications and ensure independence, impartiality, and confidentiality.

Requirements for either the PSR or the PCHF depend on whether you fall under the definition of a “farm” or a “food facility”. Draft guidance has been developed by FDA on this distinction.

Whether your business is a "farm" depends on certain definitions, i.e., the definitions for "farm," "mixed-type facility" (including a "farm mixed-type facility"), "harvesting," "packing," "packaging," "holding" and "manufacturing/processing" that are established in the regulation for Registration of Food Facilities.

The guidance includes several examples of hypothetical operations that conduct various activities. The FDA is currently reviewing these definitions and updates will be provided.

The PCHF key requirements include:

• Hazard analysis and preventive controls

• Monitoring, corrections, and corrective actions

• Supply chain approval process

• Allergen management

• cGMPs

The FDA delayed the compliance date for FDA registered food facilities which are solely packing and holding Raw Agricultural Commodities (RACs) to comply with the PCHF from 26 January 2018.

This is the date when larger businesses must comply with certain new standards. Human food facilities must meet PCHF and cGMP requirements; animal food facilities must meet cGMPs.

The first year of compliance affected the larger businesses, generally those with 500 or more employees. The human and animal food rules have staggered compliance dates, while smaller businesses have a year or more additional time to comply.

Many businesses that fall under the PCHF already have a Hazard Analysis and Critical Control Points (HACCP) program. The responses to comments written by the FDA in the PCHF rule state that the FDA does not expect facilities would need to make many changes to come into compliance.

Aspects of the cGMP and preventive controls rules are similar to HACCP and existing food safety system certification programs. See General Comment and Response 215 for more information.

You first must determine whether the packing house fits under the FDA definition of "farm" or "food facility". It is then possible to identify if the operation would be regulated by the PSR or the PCHF, and therefore exempt and controlled by the importer's Foreign Supplier Verification Program (FSVP).

Importers and manufacturers (those that will fall under the PCHF or FSVP) are responsible to ensure that the raw materials are received from "approved suppliers". This is defined as suppliers which are approved by the facility after the facility considers factors such as hazard analysis of the food and hazard controls. Supplier performance must also be verified.

Under the PCHF however, if a third party does not audit the facility for the PSR, the receiving facility must obtain written assurance that the raw material or other ingredient provided by the supplier is not subject to the PSR on an annual basis.

For PSR-exempt products, IFA or IFA plus the FSMA PSR add-on can be used as the verification step for the manufacturer (facility) or importer if it is in their supplier approval program procedures.

The Produce Handling Assurance (PHA) standard provides food safety and traceability certification of preprocessing postharvest activities such as the cooling, packing, handling, and storage of crops for human consumption. The standard incorporates FSMA requirements from both the PSR and the PCHF, aiding producers in identifying FSMA requirements that must be addressed at facility level. It is recognized by the Global Food Safety Initiative (GFSI).

Regarding environmental sampling, PHA requires that a risk assessment is conducted for pathogens, including deciding whether or not a facility must test for environmental pathogens. The control points and compliance criteria contain an annex for environmental monitoring which includes a prefatory five-question decision model to determine whether or not sampling is required. This decision will depend on whether or not the facility falls under the PCHF. For those that should test, the annex explicitly refers to the Draft Guidance for Listeria spp. sampling requirements.

If you are an importer, e.g., a US-based owner or consignee of food offered for import into the United States, or the US agency/representative of the foreign owner at the time of entry, you must comply with the FSVP for Importers of Food for Humans and Animals.

This rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets the applicable US safety standards.

The FSVP provides FDA regulatory tools to oversee food safety and ensure international growers of fresh produce comply with minimum food safety regulatory compliance. This rule is the product of a significant level of outreach by the FDA to industry, consumer groups, the agency's federal, state, local, and international regulatory counterparts, academia, and other stakeholders. FSVP requirements are risk-based according to types of foods, food hazards, and supplier performance. Importers have some flexibility in how they meet these requirements.

Importers of food from large farms that grow, harvest, pack, or hold RACs that are subject to the PSR must comply with FSVP requirements since 26 July 2018.

A single importer may have several compliance dates if they are sourcing from farms of various sizes (because the farms will need to comply with the PSR on different dates) and/or they are importing a variety of produce items, some of which are covered by the PSR and some of which are not.

Check the FDA website for latest compliance dates and information.

The FSMA PSR add-on addresses the performance of suppliers for the requisite verification activities. It serves as a record of verification efforts and audit (as one identified means of verification) of suppliers, as noted in the FSVP rule section 1.506:

• “You must retain documentation of each onsite audit, including the audit procedures, the dates the audit was conducted, the conclusions of the audit, any corrective actions taken in response to significant deficiencies identified during the audit, and documentation that the audit was conducted by a qualified auditor. The FDA has already audited importers that use GFSI-level certifications (such as GLOBALG.A.P. and others), however each importer bears responsibility for ensuring their elected standard(s) includes the required control points for the products in question.”

The successful completion of the IFA for fruit and vegetables audit with the FSMA PSR add-on, and the submission of non-compliance summaries with corrective actions as issued by a third-party accredited CB, is an example of a possible verification activity an importer could offer to a regulatory reviewer. The importer would request this information from the supplier directly.

Additionally, the GLOBALG.A.P. certification system exceeds the minimum surveillance requirements (e.g., audits per year) of the FSVP. The Qualified Individual (QI) of the importer must be able to provide evidence that the IFA audit report and FMSA PSR add-on audit was reviewed prior to approval as a supplier.

Please note that GLOBALG.A.P. certification is not a guarantee of compliance with any federal regulation, but rather contributes to FSMA implementation readiness through our standards and add-ons.

Conformance status for the FSMA PSR add-on is noted in the GLOBALG.A.P. IT systems for each producer that has successfully demonstrated compliance.

Integrated Farm Assurance (IFA) audit reports, FSMA PSR add-on audit reports, and corrective action reports are acquired directly from the producer or producer group awarded the FSMA PSR letter of conformance.

IFA for fruit and vegetables plus the FSMA PSR add-on includes key control points and compliance criteria addressed by FSMA regulations. Accordingly, producers can use this combination to demonstrate implementation efforts for FSMA compliance.

The audit must be conducted together with the IFA for fruit and vegetables audit. However, given that buying contracts may develop over a certification cycle, the add-on audit may be conducted during the current IFA for fruit and vegetables certification cycle. They will then be audited together during the next certification renewal process.

The CB may refer to the original IFA audit report in their justifications, as long as the information is still valid/current. The certification cycle for the FSMA PSR add-on will then be shortened to match the IFA certification cycle, as the expiry date on the FSMA PSR add-on certificate of conformance cannot be later than the IFA for fruit and vegetables certificate expiry date.

Producers are required by the PSR (if they are required to follow the PSR) to take the PSA Grower Training course or be trained in the course materials or an equivalent. Therefore, the GLOBALG.A.P. Secretariat included this minimum level of training for all FSMA PSR add-on auditors.

The minimum expectation for auditors is the PSA Grower Training course – with a minimum 8-hour duration, as offered by any approved trainer. This can be conducted via the GLOBALG.A.P. Academy or via a private training by an approved trainer.

See the list of Grower Training courses registered with PSA for upcoming dates.

While there is no official requirement for uploading to Audit Online Hub (AOH) in English, importers and buyers may require English-language documentation, and the GLOBALG.A.P. Secretariat requires certification bodies (CBs) to follow these requests.

Additionally, the FDA requires reports to be available in English within a reasonable time period if asked for (21 CFR 1.512(b)(5)(ii)(A)).

We recommend that this period does not exceed five days, based on the complexity of records requested and industry comment responses from the FDA. If reports are uploaded in a language other than English, the CB shall therefore be prepared to translate them within days when and if needed.