Changes coming? FDA’s proposed safety rules will impact farmers
By MARTHA FILIPIC
MEDINA — Ohio’s produce farmers may want to take some time to review the U.S. Food and Drug Administration’s newly proposed Produce Safety rule. They have until May 16 to comment before the rule is finalized, said Ashley Kulhanek, agriculture and natural resources educator for Ohio State University Extension.
After finalization, the rule will take effect for some operators within a mere 60 days.
“That’s a short period of time after finalization before they have to comply with the new rules,” she said.
The proposed Produce Safety rule, announced on Jan. 4 and published in the Federal Register today, is one way the government is putting the Food Safety Modernization Act into practice. The act was signed into law in January 2011, and growers and the food industry have been waiting since then to get details on what it will mean for their operations.
Also announced Jan. 4 was the proposed rule for Preventive Controls for Human Food, geared toward facilities that process, package or store food. Still in the works are additional rules regarding the safety of imported food and for facilities producing animal feed.
The proposed Produce Safety rule focuses on standards for growing, harvesting, packing and holding produce on farms. It is geared toward fruits and vegetables that will likely be eaten fresh. Not included is produce that is rarely consumed raw (such as potatoes) or is destined for commercial processing.
The hope is that the new rules will reduce the incidence of foodborne illness related to fresh produce: According to the FDA, between 1996 and 2010, approximately 131 produce-related outbreaks were reported, resulting in 14,132 illnesses, 1,360 hospitalizations and 27 deaths.
The rule addresses a number of areas that could affect the safety of produce on the farm, including: Irrigation and other agricultural water. Farm worker hygiene. Manure and other additions to the soil. Intrusion of animals in the growing fields. Sanitation conditions affecting buildings, equipment and tools.
The rule contains special provisions for sprouts, which are considered much more risky and vulnerable to disease-causing bacteria.
A fact sheet summarizing the rule is available at http://www.fda.gov/Food/FoodSafety/FSMA/ucm334114.htm and basic information about the rule is available at http://www.fda.gov/Food/FoodSafety/FSMA/ucm334554.htm. To comment, click the link from the Federal Register page, or go to http://www.regulations.gov and search for FDA-2011-N-0921. The Federal Register page also includes information to submit comments in writing. The 120-day comment period began today with the publication of the draft rule in the Federal Register.
After reviewing summaries of the rule, Kulhanek said she sees no real surprises.
“There’s an exemption for small farms just like the FDA said there would be,” she said. “And the proposed rule allows states to request variances from some or all provisions depending on local growing conditions.
“So, if there’s an instance where one of the rules might seem unattainable by the farms in the region, the state can apply for a variance, or a different way of doing things, so farmers can still grow their produce as long as it’s proven safe.”
To determine if an operation is exempt from the rules, see the flow chart available here: http://www.fda.gov/Food/FoodSafety/FSMA/ucm334554.htm — happen.
Kulhanek said she expects Ohio State will be asked to do some research in the future to help determine those safe alternative practices for local growers.
Before taking her new position as an OSU Extension educator in Medina County, Kulhanek was the coordinator and primary instructor of Ohio State’s Good Agricultural Practices (GAPs) Education Program (http://producesafety.osu.edu), a program sponsored by the Department of Horticulture and Crop Science in Ohio State’s College of Food, Agricultural, and Environmental Sciences, and delivered by Kulhanek and county Extension educators.
The three-hour GAPs workshops have been held throughout the state for about five years to assist Ohio’s produce growers in adopting practices to keep produce safe. Currently, a grant from the Ohio Department of Agriculture’s Specialty Crop Program allows the workshops to be offered for just $10 per person, a significant discount.
Kulhanek, who remains one of the instructors of the GAPs programs and is Ohio’s representative to the National Produce Safety Alliance, said she believes the new regulations on water quality may be the biggest challenge for Ohio’s growers.
The proposed rule states that water used for produce “be safe and of adequate sanitary quality for its intended use,” and that “specific criteria for the quality of agricultural water be established for water that is used for certain purposes, with proposed requirements for periodic analytical testing.”
“If you’re irrigating, getting clean water for crops it not always easy,” Kulhanek said. “A lot of growers use streams or creeks, ponds, reservoirs, open sources, and the quality of water can change from day to day.
“If an animal dies in the water, bacterial counts will go way off the charts. And the cost or frequency of testing water quality might be an issue. I think it’s going to be something a lot of people will comment on.”
Paying for new equipment or training of employees might also be an issue for some growers, she said, “but it can be done.”
The risk posed by wildlife or other animals defecating in fields may also be a difficult issue for growers to manage, Kulhanek said.
“It’s my assumption that the FDA understands that it’s not going to be perfect,” she said. “Wildlife is unavoidable.”
One key is scouting and inspection, Kulhanek said.
“Growers are going to have to take some time to walk or drive the perimeter of produce fields to see if wildlife have been walking through, if there’s been some heavy deer traffic, for instance. If they find signs of wildlife, they’ll have to figure out a way to handle it.
That can be done by adding fencing, noisemakers, or some other kind of repellent, she said.
According to information on the FDA’s website, FDA will not require fencing of farms, habitat destruction, or animals to be harmed in order to comply with animal intrusion regulations, Kulhanek said.
“The FDA or auditors will want to see that growers have used due diligence, that they have made the effort to do a preliminary risk assessment before planting and before harvesting, and have taken pro-active measures to prevent those risks where possible,” Kulhanek said.
She encourages all Ohio produce growers to attend GAPs training, even if they are small farmers or are otherwise exempt from the new rules.
“Any grower can make improvements to help make produce safer overall,” she said.
Besides, although the FDA may not force small growers to abide to the new rules, grocery chains or produce auctions may decide that even those exempt by FDA’s standards are not exempt in their eyes.
“Buyers want safe food, period,” she said.
Upcoming trainings were held in January as part of the Ohio Produce Growers and Marketers Association Congress.
More programs will be planned when a new program coordinator is hired, said Doug Doohan, professor of horticulture and crop science, and the originator and leader of the GAPs training program.
“Everyone has to realize that there’s no such thing as 100 percent risk reduction,” Kulhanek said. “There’s no such thing as 100 percent safe when you’re talking about fresh produce.
“But there’s always room for improvement.”