COLUMBUS, Ohio — Ever since the Food Safety Modernization Act was signed into law in January 2011 and the act’s Produce Safety Rule was proposed two years later, fruit and vegetable growers have waited for the U.S. Food and Drug Administration to finalize the regulations they will be expected to follow on the farm.
Now that the FDA has done so — the final Produce Safety rule was printed in the Federal Register on Nov. 27, 2015 — growers and fresh produce handlers must learn what it means for their operations, said Peggy Hall, field specialist in agricultural and resource law for Ohio State University Extension.
OSU Extension is the outreach arm of The Ohio State University’s College of Food, Agricultural, and Environmental Sciences.
The rule is designed to reduce the frequency of foodborne illness outbreaks associated with contaminated produce. The FDA estimates that about 348,000 illnesses per year could be prevented because of the new rule’s provisions.
“There’s a lot to this rule,” Hall said.
That’s one reason why it took so long to finalize — that, and the fact that the FDA made numerous revisions to the original proposal based on comments from growers nationwide, she said.
“I think the first thing to look at is who the law does and does not apply to,” Hall said.
Farms that sell an average of $25,000 per year or less of produce during the previous three years are exempt, as are farms of any size that grow only produce normally cooked or processed before being eaten, such as asparagus, dry beans, beets, sweet corn, potatoes and pumpkins.
In addition, larger farms could meet the standards for a “qualified exemption,” which would exempt them from some of the new regulations, Hall said. To qualify, their overall food sales would have to average less than $500,000 per year in the last three years, and most of those sales need to be direct to consumers or to local restaurants or retail establishments — those located in the same state or not more than 275 miles away. Farms with a qualified exemption must still keep certain documentation and must disclose on a label or at the point of purchase the name and location of the farm where the food was grown.
“There are going to be a good number of growers in Ohio who are not subject to the rule or that will fall under the qualified exemption,” Hall said.
Still, even if growers are exempt, commercial buyers might insist that any farms they buy produce from follow the new rule voluntarily, she said.
“A lot of these requirements are GAPs (good agricultural practices), and there’s talk that they are going to become the new industry standards,” Hall said. “Purchasing produce from farms that follow these standards, even if not required by the FDA, could reduce a buyer’s liability if anything happens.”
The rule covers:
- Biological soil amendments, or using manure or compost as fertilizer.
- Water quality and testing, for irrigation water, handwashing water, and water used elsewhere on the farm.
- Potential contamination of produce by domestic and wild animals.
- Worker training, health and hygiene.
- Standards for equipment, tools and buildings.
- Special requirements for growers of sprouts, which are especially vulnerable to microbes because of the warm, mois, nutrient-rich conditions necessary to grow them.
The rule covers not only farms but firms that pack or store fresh produce, Hall said.
A summary of the rule’s key requirements is online at www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm.
Manure and other biological soil amendments
During the comment period of the original proposed rule, many growers in Ohio and elsewhere voiced concern about a potential 270-day waiting period — essentially, nine months — between the application of untreated manure on land and harvest.
Organic growers, who commonly use manure as fertilizer, had been operating under regulations requiring just a 90- or 120-day waiting period depending on whether the edible portion of the crop comes into contact with the soil. A 270-day waiting period would be unreasonable and would make it impossible to farm, they said.
Government officials listened, Hall said.
“The FDA really backed away on that 270-day period,” Hall said. “What they decided to do is to conduct a risk assessment to try to clarify the waiting period needed in order to remove the risk associated with manure coming into contact with produce growing in a field.
“The science required to determine that could take five to 10 years.”
In the meantime, the FDA says it “does not object” to farmers complying with the U.S. Department of Agriculture’s National Organic Program standards, which require the 90- or 120-day interval. The rule also states that raw manure and other untreated biological soil amendments of animal origin must be applied in a manner that does not contact produce during application and that minimizes the potential for contact after application.
The rule also provides standards for compost and other treated soil amendments.
The FDA is concerned about food safety problems resulting from defecation of wild and domestic animals in produce fields, but initially growers openly wondered how they could prevent that from happening. The final rule requires farmers to continuously examine their growing areas for potential contamination by animals,to not harvest produce that is likely to be contaminated, and to take other measures in special circumstances as well.
The rule’s provisions regarding water quality on produce farms might be its most complex part, Hall said. It has a strict standard — no detectable generic E. coli is permitted — for water used on the farm that could potentially come into contact with produce, such as water used for washing workers’ hands during and after harvest, and water used on food-contact surfaces. Water used for growing produce, such as irrigation water, must meet a lower standard but still must be tested to be sure it meets the requirements. If water doesn’t meet the new criteria initially, farms have some time to make improvements.
In fact, most of the new requirements don’t require compliance for two years for the largest farms, Hall said, and up to four years for smaller farms. Growers are given an additional two years for meeting certain aspects of the water quality standards.
“It allows a lot of our smaller growers to take a deep breath and figure things out,” she said.
However, the timeline for growing sprouts is faster, Hall said. And farms operating under modified requirements under the qualified exemption must retain records as of Jan. 16, 2016 — the effective date of the rule — to prove they qualify.
The rule contains many more details that growers should become familiar with, Hall said. The FDA has an hourlong webinar on the Final Rule on Produce Safety online at www.fda.gov/Food/GuidanceRegulation/FSMA/ucm471649.htm. The final rule itself is online at www.regulations.gov/ - !documentDetail;D=FDA-2011-N-0921-18558.
OSU Extension’s Fruit and Vegetable Safety Program will offer seven-hour workshops to assist growers in complying with the new rule after OSU Extension faculty and staff undergo training by the Produce Safety Alliance and become certified by the Association of Food and Drug Officials, which is necessary to meet FDA approval. This training is tentatively scheduled for March but may be delayed depending on the finalization of the Produce Safety Alliance curriculum.
Workshops for growers will be scheduled after trainers become certified and will be on the program’s website, producesafety.osu.edu/.