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The Produce Safety Rule of the Food Modernization Act (FSMA) set a new era in food safety for produce growers. As the Food and Drug Administration (FDA) states in the Introduction to the final rule, “The rule establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption.”

With an effective date of Jan. 26, 2016, the first major compliance date (except that for sprouts) comes due on Jan. 26, 2018, which means that produce growers have 2017 to get their (green)houses in order for compliance — even many who are legally exempt.

Two of the key provisions of the rule intended to reduce what FDA assessed to be major routes of contamination of fruits and vegetables include a focus on pathogen detection and prevention in agricultural water and biological soil amendments. A brief overview of these follows.

Agricultural water quality and testing

“The overarching mandate of the requirements for agricultural water quality is that it be safe and sanitary,” says David Acheson, former FDA associate commissioner of foods and founder and president of The Acheson Group. Based on the presence of generic E. coli, which can indicate fecal contamination, the rule establishes two sets of criteria for microbial water quality:

  • No untreated water or water with detectable generic E. coli is allowed for uses such as washing of hands, food-contact surfaces or produce during or after harvest, through which the pathogen could be transferred to produce directly or indirectly. If E. coli is detected, use must be stopped and corrective action taken.
  • For agricultural water that is directly applied to growing produce (other than sprouts), FDA set criteria based on two values: the geometric mean (GM), of 126 or less colony-forming units (CFUs) of generic E. coli per 100 mL of water, and the statistical threshold (STV), of 410 CFU or less of generic E. coli in 100 mL of water. Further details on establishing a microbial water quality profile and tools for conducting these calculations are available through the universities of California and Arizona, with links to both at bit.ly/2jHbaIZ. FDA is also considering the publication of an online tool for growers.

Testing of agricultural water and its frequency is based on the type of source. If untreated surface water is directly applied to produce, an initial survey is to be conducted with at least 20 samples collected near harvest over two to four years. For untreated ground water applied to produce, an initial survey of at least four samples is to be collected close to harvest, during the growing season, over a period of one year. In both cases, the survey results are used to conduct GM and STV calculations. Then, after the initial survey, growers are to conduct annual surveys of at least five samples, combine those with the previous most recent 15 samples, and create a rolling database for updating the calculations.

Biological soil amendments

“Although FDA focuses on biological soil amendments of both animal origin and human waste, FDA would never allow the use of human waste on produce,” Acheson says. As such, this article discusses only those of animal origin, for which the rule addresses two key points: raw manure and stabilized compost.

If your retail customers must be compliant with the Produce Safety Rule, your operation must be compliant as well.
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FDA states that raw manure must be applied so that it does not contact covered produce during application and so post-application contact is minimized. The agency is currently conducting a risk assessment to determine the number of days that should be required between application and harvesting. Meanwhile, it “does not object” to compliance with USDA’s National Organic Program standards, which call for a 120-day interval for crops that contact the soil and 90 days for crops that don’t.

The rule also sets microbial standards for limits on detectable amounts of Listeria monocytogenes, Salmonella, E. coli 0157:H7 and other bacteria for processes used to treat biological soil amendments, including manure. Stabilized compost that meets these standards (two examples of which are given in the rule) is then to be applied in a way that minimizes contact during and after application.

For complete information on the agricultural water, biological soil amendment, and other provisions of the Produce Safety Rule, see the full rule in the Federal Register at bit.ly/2iBEdjg

Regulatory vs. customer requirements

With FDA having determined, in its 2013 Analysis of Economic Impacts of produce standards, that 956 of the 1,128 produce-growing greenhouses (as cited from the 2007 Census of Agriculture) would be considered small or very small operations, up to 85 percent of greenhouse growers could expect to be exempt from the rule or at least have extended compliance dates. However, it’s not quite that simple.

The rule does state that “farms” that have an average annual value of produce sold during the previous three-year period of $25,000 or less are exempted, and qualified exemptions are granted for farms that have food sales averaging less than $500,000 per year and whose sales to local (same state or within 275 miles) end-users exceed all other sales combined.

But, even when legally exempt, produce growers may need to comply with the rule to meet requirements of its downstream customers. That is, if you sell — or want to sell — produce to a retailer whose supplier requirements include compliance with FSMA, you will need to ensure you are following all the rules, even if you are exempted by the language of the law.

For example, in 2007, well before FSMA was introduced as a Congressional bill, Walmart created a rule that all food suppliers who wanted to sell in its stores would have to be certified to the Global Food Safety Initiative (GFSI) standards. “We saw that suppliers were trying to do the right thing, but many were doing different things,” said Walmart Vice President of Food Safety Frank Yiannas. The requirement put many suppliers well on the road to FSMA compliance — even exceeding compliance in some areas. Additionally, as found by a Walmart study which analyzed the impact of GFSI certification on product recalls, “The results suggest that a food manufacturer that achieves a GFSI-recognized certification is significantly less likely to experience a food withdrawal or recall.”

This was further validated in a presentation Acheson made at a GFSI briefing in January, in which he revealed the results of a comparative analysis of the GFSI Benchmarking Requirements V7 and FSMA’s Preventive Controls Rule. “GFSI generally meets or exceeds all of the requirements in the FSMA preventive control rule,” he said. “In some cases, GFSI has requirements not reflected in FSMA.”

With the combination of food companies requiring certification to GFSI standards and FSMA’s new supply chain control requirements, many downstream food facilities and retailers are enforcing increasingly more robust supplier requirements. “Customer requirements are often stricter and of even greater significance to a company’s bottom line than are those of our federal regulators,” Acheson says. Thus, exempt or not, produce growers can either meet the requirements or seek out another buyer with lesser requirements.

Lisa is editor of sister publication Quality Assurance & Food Safety (QA) magazine. llupo@gie.net