Farmers prepare to comply with food-safety rule

Issue Date: January 24, 2018
By Christine Souza

With a phase-in of additional food-safety regulations beginning this week, California farmers say they have adjusted facilities, procedures and staffing to comply with the federal rules.

On Jan. 26, the Produce Safety Rule takes effect for "large farms" as defined by the U.S. Food and Drug Administration, marking the latest phase of Food Safety Modernization Act implementation. The law, passed seven years ago this month, led to regulations that affect produce growers, processors of human and animal food, importers, auditors, transportation firms and others involved in the food chain.

Jeff Marchini of Marchini Farms in Le Grand, who grows radicchio, kale, fennel and other crops, said his operation is prepared for what's to come under the Produce Safety Rule, adding that he has hired a full-time employee to serve as manager of food safety.

"We had been addressing food safety by committee, but realized that we are better off if we had someone working on food safety full time. We put a full-time person on it because we knew it would be changing, especially with the new FSMA law," Marchini said.

"The amount of attention we put on food safety and the amount of dollars that we have in food safety is a cost of doing business," he said. "We can't afford to have a food-borne illness."

Farmer Tim Chiala of George Chiala Farms in Morgan Hill, who grows and processes peppers, garlic and leafy greens, noted that growing produce falls under the Produce Safety Rule and processing produce falls under a separate FSMA rule: Preventive Controls for Human Food. That rule pertaining to large farms took effect in 2016.

"On the processing side, there's much more detail. You are pretty much taking it from an audit approach to, if this happens, how are you going to prove your innocence?" Chiala said.

Despite the added requirements, Karen Dawes, director of quality assurance for George Chiala Farms, said, "We are well prepared for the change."

For food processors, Dawes said, the Preventive Controls for Human Food Rule means additional monitoring and documentation to ensure the company is controlling the hazards of identified risks.

The Produce Safety Rule includes regulations on biological soil amendments; domesticated and wild animals; worker training, health and hygiene; agricultural water and testing; and equipment, tools and buildings.

The rule's phase-in this week applies to farms with more than $500,000 in annual sales over three years. The FDA proposed that compliance for the agricultural water and testing part of the rule for large farms take effect on Jan. 26, 2022.

Enforcement will be carried out by California Department of Food and Agriculture inspectors, starting with large farms in 2019. Agencies have said they intend to focus on education and readiness, rather than enforcement, during the first year of implementation.

Many large California produce farms already comply with similar food safety regulations as members of the Leafy Greens Marketing Agreement, which was established in 2007. But Josh Rolph, California Farm Bureau Federation manager of federal policy, said the new requirements under FSMA will be burdensome and costly, especially for fruits, vegetables and nuts with no prior links to food-borne illness.

"Where FDA erred is to regulate all commodities the same, regardless of whether they have been linked to food-borne illness in the past," Rolph said.

For medium-sized farms as defined by FDA—those that generate $250,000 to $500,000 in annual sales over three years—the Produce Safety Rule begins to take effect a year from now; for small farms—$25,000 to $250,000 in annual sales over three years—it takes effect in 2020. Very small farms, with $25,000 in annual sales or less, are exempt, as are commodities FDA has identified as rarely consumed raw. As with large farms, enforcement is set to begin one year after the rule takes effect, with additional time to comply with regulations related to agricultural water and testing.

David Runsten, Community Alliance with Family Farmers policy director, said he expects small farmers definitely will be affected by the added FSMA regulations.

"The big cost to people is going to be implementing these practices and keeping records all of the time. It will just be very time consuming. It's not going to be good for your small farmer," Runsten said.

"There's just a bunch of records that are required along the way with this rule, and I think that's something that a lot of people aren't used to doing," he said, adding that small farms that farm organically may be more familiar with recordkeeping and could better adjust to the new regulations.

To meet the rule's requirement that at least one supervisor or responsible party from the farm is trained in food safety, CFBF, the Farm Employers Labor Service and the Safe Food Alliance formed the Food Safety Training Partnership to offer FDA-approved training for farmers and employees.

Katie Ward, senior marketing manager for the Safe Food Alliance, said medium-sized and small farms should begin familiarizing themselves with the rule soon, if they haven't already done so.

"I know we are a year away from the small businesses to the very small businesses that have to be in compliance, but if you can be prepared for it, the sooner the better," Ward said.

Meanwhile, Rolph said, the FDA has yet to release an implementation-guidance document that will outline how FSMA regulations will be applied.

"The guidance should give our growers more specific direction on how to comply with the rule," Rolph said. "Training is happening, yet we still don't have the guidance, which leaves a lot of unanswered questions about how specifically to comply."

The FDA said it expects to publish the guide this spring.

For information about upcoming Food Safety Training Partnership workshops, offered in English and in Spanish, seeĀ; call 916-561-5672 or email For more information about FSMA, see

(Christine Souza is an assistant editor of Ag Alert. She may be contacted at

Permission for use is granted, however, credit must be made to the California Farm Bureau Federation when reprinting this item.