By Charles Breen, Independent Advisor for FSMA
The coming year will be a busy one for food firms as the compliance date for 14 components of the FSMA Final Rule come into effect. FDA has published a helpful tool, Key Dates for Compliance, which runs through 2024 and this quick, color-coded reference offers a handy visual for determining when the compliance date for each area of FSMA goes into effect.
Of particular note is the compliance date of January 26, 2018 for the Produce Safety Requirement for large firms, (except certain water requirements) which applies to growers of fruits and vegetables that are consumed raw, with a few exclusions – specific types of produce that are rarely consumed raw (such as asparagus, coffee beans and pumpkins); those which would undergo further processing reducing the likelihood of contamination by microorganisms that could harm public health; produce which is grown for personal use; farms which have a three year annual sales totaling less than $25,000 and produce which is not a RAC.
A brief review of the water requirements makes clear why the agency is taking more time to find a way to protect consumers that is also practical and efficient for producers. Right now, the Produce Safety requirements and benchmarks for water testing are designed to be flexible, depending on the agricultural use and whether the water is received from municipal sources or other systems that have acceptable established standards, such as valid certificates of compliance that the water meets relevant requirements, or if the water is treated in compliance with the rule. Its very flexibility is leaving many producers wondering what would work best, if at all, in their own particular case.
Agricultural water is estimated to be the most significant pathway of E. coli contamination. So, it is unacceptable for water used in hand washing during and after harvest, water used on food contact surfaces, that comes in direct contact with produce (including ice) during or after harvest, or that is used for sprout irrigation to have any trace of E. coli.
Untreated surface water that is directly applied to growing produce (other than spouts) is considered to be the most vulnerable to external influences. FDA requires farms to do an initial survey, using a minimum of 20 samples, collected as close as is practicable to harvest over the course of two to four years. After that, an annual survey of a minimum of five samples per year is required. Those five newest samples in combination with 15 of the most recent samples will create a “rolling dataset” of 20 samples for use in confirming the safety of the water in use.
For untreated groundwater that is directly applied to growing produce (excluding sprouts) farms must take a minimum of four samples, again collected as close as is practicable to harvest, during the growing season or over a period of one year. After that, a minimum of one sample should be taken annually and that latest sample, combined with three of the previous samples will create the rolling dataset of four samples confirming that the water is appropriate for use.
The water’s safety is calculated using these samples through a complex statistical process with two sets of criteria for microbial water quality called the geometric mean (the average amount of generic E. coli in a water source) and statistical threshold (the amount of variability in the water quality). The sample’s generic mean must be 126 or less CFU of generic E. coli per 100 mL of water and the statistical threshold must be 410 CFU or less of generic E. coli in 100 mL of water. The determination of these statistical analyses may be confusing and FDA is considering the creation of a usable online tool to help make sense of individual data.
In the many US produce growing areas, the only available water for irrigation is untreated surface water that does not and cannot practically be treated to meet the microbiological criteria in the current rule. There is scant evidence of harm to consumers from the use of these water sources in some areas. At the same time, there is ample evidence of the risk that untreated surface water does cause illnesses in human. FDA is taking more time to sort out why what seems to be equally unacceptable agricultural water does cause illness in some situations but not in others.
There are numerous other components to the Produce Safety Rule such as a Biological Soil Amendment, which is somewhat in flux as the agency continues to assess the number of days needed between the applications of raw manure as a soil amendment and crop harvesting in an effort to minimize the risk of contamination. Currently, FDA thinking states that untreated biological soil amendments of animal origin must be applied in a manner so that it does not contact covered produce during application and minimizes the potential for contact with covered produce after application. FDA also feels that the USDA’s National Organic Program standards, which call for a 120-day interval between the application of raw manure for crops in contact with the soil and 90 days for crops not in contact with the soil to be a prudent approach while it continues its own risk assessment.
There is also a provision for working and grazing animals, whereby farmers that allow animal grazing on land where produce is also grown should take every reasonable step to not harvest produce that is likely to be contaminated and should consider (but are not required) to implement waiting periods between grazing and harvesting.
Workers and visitors to the farm or facilities must be educated on and use good hygiene practices such as washing hands, and workers who handle covered produce and food contact substances must have must have training, education, and experience to perform their responsibilities and have adequate tools, equipment and buildings to do so in a manner that prevents contamination such as appropriate storage, maintenance, clean equipment, and tools.
Lastly, sprouts have received much attention as they are particularly susceptible to microbes causing foodborne illness and there are numerous testing requirements under the Produce Safety Requirement, many of which pertain to water usage. Among other requirements, farms must test spent sprout irrigation water from each production batch or in-process sprouts for certain pathogens. In addition, sprouts cannot be allowed to enter commerce until these pathogen test results are confirmed to be negative.
In an agency Q&A on Water Safety Requirements it was noted that the Produce Safety Requirement is anticipated to bring about a reduction of over 60 percent in the risk of contamination from agricultural water, and a reduction of about 20 percent in the total number of foodborne illnesses associated with produce with an expected overall reduction in costs related to foodborne illnesses of $477 million.
What does all this mean? For one, FDA now has enforceable regulations for both domestic and international produce growers for the safe growing, harvesting, packing and holding of fresh produce. The specific requirements with regards to water testing leave no room for interpretation as to what constitutes a safe supply and FDA will request access to that data history for their own assessments of safety. As with any compliance requirement, accurate and complete documentation is necessary to satisfy FDA requirements. Under § 112.161(a)(1), all records required must include, as applicable, the name and farm location, actual values, and observations obtained during monitoring, an adequate description of covered produce applicable to the record, the location of the growing area or other areas applicable to the record, and the date and time of the activity documented, signed and dated. These records must be kept in a safe location, whether electronic or paper storage for a period of time. That time, however, is currently undetermined as FDA has not yet addressed issues related to traceability and additional record keeping of high-risk foods as mandated under FSMA section 204.
Visit FDA’s FSMA Final Rule on Produce Safety for more details on the components of the Produce Safety Rule including Draft Guidance for Industry for the Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption of Sprout Operations.
After January, the next FSMA compliance date will be March 19, 2018, with new requirements for importers of human and animal foods. Stay tuned…