As FDA issued a rule in March that finalized its extension of the Food Safety Modernization Act Produce Safety Rule (PSR) compliance dates, researchers at Cornell University’s Produce Safety Alliance are working to simplify the process of compliance with agricultural water standards. In a paper published in mid-February, the Produce Safety Alliance—a partnership between Cornell, the FDA, and USDA—reflected on the national water summit it held last winter in Covington, Ky., to better understand agricultural water implementation challenges for both growers and FDA. At issue in last year’s discussion was Subpart E of the PSR, which deals with agricultural water, and above all the most pressing subject for many has been the cost of testing water according to PSR demands.
Don Stoeckel, PhD, Midwest regional extension associate, Produce Safety Alliance, is one of the authors of the paper, which concluded by calling for training, outreach, and technical assistance for farmers, and increased transparency from FDA. He tells Food Quality & Safety that the details are important: With the cost of a single water test ranging from $30 to $60, not counting the time to collect the sample, transport it to the lab, evaluate test results, and maintain records, he says a year’s worth of tests can easily add up in the hundreds or thousands of dollars for an individual farm. However, he stresses that we still know so little about agricultural water safety that the benefits of such testing are uncertain.
The Complexity of Water
“There is little by way of direct evidence that [EPA] standards [for recreational water, to which FDA’s standards are similar] have the same link to public health when applied to consuming irrigated produce,” Dr. Stoeckel says. “EPA established a scientific basis for their criteria from illness resulting from incidental ingestion of swimming-beach water. In other words, EPA has science to show that the standards help know when water is safe enough to swim in, but FDA does not have much science to show that the same standards help know when water is safe enough to irrigate with.”
Though there is plenty of proof that the quality of agricultural water affects the safety of produce, Dr. Stoeckel says, “To my knowledge, epidemiological data to correlate any water quality parameter with public health outcomes is lacking. Without such underlying data, science-based quantitative standards are more difficult to support.”
The reason for both the compliance-date extension and the water summit last year were simple: Water is complex, and agricultural water is even more complicated. FDA said March 18 that compliance-date extensions were necessary “to address questions about the practical implementation of compliance with certain provisions and to consider how we might further reduce the regulatory burden or increase flexibility while continuing to protect public health.”
Betsy Bihn, PhD, senior extension associate and director, Produce Safety Alliance, and another of the paper’s authors, added, in a press release, “The United States is a big place with many different water sources and systems.”
Complying with Requirements
One of the key results from the water summit, comments Dr. Stoeckel, was the conclusion that “meeting PSR water requirements, as currently written, is a concern in terms of cost and value to risk assessment.”
Dr. Stoeckel specifies that the costs of testing simply added up to far more than the benefits to produce safety, particularly considering that to date, scientists and regulators have not been able to make a quantitative link between more expensive sampling and management acting on sample results and reduced food safety risk.
“We generally agree that less fecal material and other contamination on produce means less risk to public health,” Dr. Stoeckel says. “However, it is very difficult to propose action levels/standards based on generic E. coli concentration or other measurements.”
Dr. Stoeckel is quick to say that water with fecal contamination is bad for produce safety, and that fact will not change.
“The main things that may change,” he says, “are how that fecal contamination is measured, and what steps are taken to protect produce safety based on the level of fecal contamination. Good Agricultural Practices call for analysis of generic E. coli in water used for fresh produce to detect fecal contamination, and farmers should continue that type of testing to help understand the quality of their water.”
Farmers are adaptable, and Dr. Stoeckel has no doubt they will be able to adapt to and meet requirements necessary to produce safe and healthy food. However, farmers need to understand the changes FDA is implementing and the reasoning behind them—which is why it was important to discuss and simplify the rule.
“All of us will benefit from plain language […] from FDA to explain compliance strategies for any new requirements,” he says. “Given sufficient time, and support (education, financial, infrastructure), the farms will be able to meet the requirements.”
The next steps will be FDA’s. The federal agency came away from the meeting last year with information from stakeholders across the industry about their needs, and Dr. Stoeckel says he trusts FDA will build on that knowledge to “re-evaluate and possibly alter the requirements of Subpart E.”