Compliance to FSMA Produce Safety Rule can Enhance Fruit and Vegetable Exports to USA

India’s exports of fresh fruits and vegetables to USA stood at 3,018 MT valuing 8.61 million USD in 2019-20 as against 2,541 MT valuing 7.97 million USD in 2018-19. Fresh mango exports alone constituted 1,095 MT at 4.35 million USD (Source: APEDA). However, Covid-19 affected the mango exports to US since USDA inspector could not visit India for pre-clearance as part of phytosanitary procedures. Besides mango, other significant fruit and vegetable exports to USA include Pomegranate, Onion, Garlics & Fresh Turmeric which are also covered under the FSMA Produce Safety Rule.

Produce Safety rule (PSR) is one of the seven rules under US FDA’s FSMA which could impact the Indian exporters of fresh produce to USA. The PSR establishes science-based minimum standards (based on a foundation of Good Agricultural Practices (GAPs)) for safe production and harvesting of fresh fruits and vegetables. Requirements of the rule focus on major routes of contamination including: (i) Worker health & hygiene, (ii) Agricultural water (iii) Biological soil amendments of animal origin (iv) Domesticated and wild animals (v) Equipment, tools, buildings, and sanitation; and related topics that include personnel qualifications and training; growing, harvesting, packing, and holding activities; and (vi) sprouts.

The rule does not apply to food grains and produce that is not a raw agricultural commodity. FDA has identified few commodities as rarely consumed raw like kidney beans, sugar beets, cocoa beans, coffee beans, eggplants, ginger, okra, peanuts, potatoes, etc. and hence are excluded from the rule. Under the PSR, agricultural water and biological soil amendments of animal origin are the critical requirements along with respective record keeping requirements and Indian growers/ suppliers could face some challenges in implementing these elements of the rule. However, meeting PSR requirements may be less challenging for growers who have already adopted GAPs (with certification) and are also part of supplier approval programs for global players.

Agricultural Water for Production and Postharvest Uses

The PSR covers the Agricultural water that is intended to, or is likely to, contact the harvestable portion of covered produce or food-contact surfaces. Agricultural water includes (i) Production water used during growing activities for produce and (ii) Postharvest water used for certain activities during and after harvest. For production and postharvest water, PSR has established two different microbial water quality standards based on the presence of generic E. coli. Postharvest water must meet the standard of no detectable generic E. coli/ 100 ml water sample. Untreated surface water cannot be used for postharvest uses and if the produce comes in contact with flood water from overflowing open bodies of water, it is considered adulterated by the FDA and cannot be used for food. The rule requires water testing at a frequency depending on the type of water source. The documentation requirements for agricultural water include findings of the inspection of agricultural water system, results of analytical tests, monitoring of water treatment, and corrective measures taken if agricultural water does not meet the water quality criteria.

In Dec 2021, FDA has proposed revisions to water requirements and recognizing that the current agricultural water compliance dates for covered produce other than sprouts under the PSR are set to begin in January 2022, FDA intends to exercise enforcement discretion for those agricultural water requirements while pursuing to extend the compliance dates for all the agricultural water requirements in the PSR. FDA has given provisions for permitting requests for variances from one or more of the PSR requirements, wherein foreign country may determine that the variance is necessary considering local growing conditions and the procedures and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated and provides the same level of public health protection. Such requests for variances must be submitted to FDA through a petition.

Biological Soil Amendments of Animal Origin (BSAAO)

Implementing Good Agricultural Practices (GAPs) on the farm can help reduce risks associated with the use of soil amendments. Raw manure, aged manure, untreated slurry, etc are considered as untreated soil amendments posing higher risk. PSR defines the treated soil amendment as having been processed to completion to reduce microorganisms of concern. PSR provides the standards for composting processes and provides static and turned composting, as examples of validated options for treating manure and other soil amendments. For farms producing compost on site, process monitoring to meet the microbial standard and recordkeeping are critical to ensure the compost is adequately treated. For BSAAO purchased or received from a third party, documentation must be provided and kept by the growers to show that process used to treat the soil amendment is a scientifically valid, carried out with appropriate monitoring and prove that process minimizes the risk of contamination. In case the BSAAO suppliers do not have documentation of the treatment process (e.g., certificate of conformance), growers should handle them as untreated amendment or consider finding another supplier who can provide appropriate documentation. PSR also has requirements for application method and application to harvest interval.


In addition to above, PSR also has requirements for documenting (i) personnel qualifications and trainings for various operations and (ii) operations related to equipment, tools, buildings, and sanitation used for harvesting, packing, or holding activities.


FSVP importers requirements

Under the FSVP rule, the FSVP importer in US will be accountable for verifying that their Indian or foreign suppliers of fresh fruits and vegetables covered under PSR are producing the food in a manner that provides the same level of protection as produced domestically in accordance with regulation.  FDA began routine inspections of large farms subject to the PSR, including large produce farms in other countries, in 2019. It also began Foreign Supplier Verification Programs (FSVP) inspections of importers of produce from large farms in other countries in Fall 2019.

Indian growers and exporters of fresh fruits and vegetables need to adopt the GAPs, measures & processes that minimize the risks of contamination and develop good documentation system as per PSR requirements. It is also important for exporting firms/ farms to invest in training their farm supervisors on the requirements of PSR. The PSR requires that “at least one supervisor or responsible person on a covered farm must have successfully completed food safety training at least equivalent to that received under the standardized curriculum recognized as adequate by FDA. The Produce Safety Alliance curriculum is recognized as one way to satisfy this training requirement.

Please reach out to Sathguru at for support on Produce Safety Rule compliance and training requirements.



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