States and FDA prepare for on-farm inspections

Former U.S. president Ronald Reagan once said the most terrifying words in the English language are, "I'm from the government and I'm here to help."

Whether helpful or terrifying, fruit and vegetable growers will experience a new layer of government involvement beginning in 2018, when government food safety inspectors will be tasked with performing inspections on U.S. farms.

The Food and Drug Administration is working with states as it enters the unchartered territory of first educating and then enforcing produce safety rules at the farm level.
For fiscal year 2018, the FDA plans to work with states to design and pilot an initial model for inspections on farms, according to Sylvia Ballinger, health communications specialist for the FDA.

In September, the FDA awarded a total of $21.8 million to support the 42 states that requested assistance with implementing the produce safety rule.

Representing food safety inspectors, Joe Corby, executive director of the Association of Food and Drug Officials, York, Pa., said the FDA's approach to enlist state assistance is sound.

Corby expects states will work with cooperative extension officials and explain the rules to growers, including who is exempt, who will comply, and what rules growers need to follow.

"This is probably the first time that FDA has decided to go educate before they regulate," he said.

The National Association of State Departments of Agriculture and states are working with the FDA to develop and maintain a record or roster of produce operations in each state, said Jim Gorny, vice president for food safety and technology at the Newark, Del.-based Produce Marketing Association.

Many states are preparing to play a role in education and outreach about the produce safety rule, and also are designing and implementing a produce safety rule compliance program, Gorny said.

FDA will lean on state inspectors to do produce safety inspections on farms, said David Acheson, former FDA official and founder and CEO of The Acheson Group.

"Historically, the FDA only goes on a farm when it has been linked to an outbreak," he said. "States are much more familiar with agriculture than the FDA has been traditionally and is right now."

Ballinger said in an e-mail that the FDA will conduct inspections if any state is unwilling or unable to do so.

Acheson said the states have a greater agricultural expertise, and perhaps to some degree, so does the U.S. Department of Agriculture's Agricultural Marketing Service.

"The fact is the (FDA) doesn't have the resources or the people to be able to adequately inspect produce farms in any way," he said. "They don't have the people and they don't have the funding to hire them."

The Food Safety Modernization Act mandates that the FDA builds partnerships to get the job done, including relationships with regulatory and public health agencies both at the federal, state and local levels and the private sector.

There is precedence for FDA working with state inspectors. The FDA has used state inspectors to inspect milk plants and operations subject to federal seafood regulations.
The FDA may also acknowledge the value of Global Food Safety Initiative and Leafy Greens Marketing Agreement-type certifications which the industry has developed, Acheson said.

"Put all that together and that's about the only way they can get the job done," he said.


Nearly $22 million was awarded to the states last September in the cooperative agreement, and the California Department of Food and Agriculture received more than $1 million.

Compliance with the Produce Safety Rule may begin as early as January 2018, according to Steve Lyle, director of public affairs for California's

department of agriculture. Additional time has been allotted by FDA for the requirements related to water testing. Compliance timelines are based on sales, with the largest operations due to comply the earliest.

California and other states are communicating with the FDA and the association of state agriculture departments on implementation procedures, data collection, and education/outreach activities, Lyle said in an e-mail.

All states that received grant funding will be attending a consortium workshop the end of February.

"FDA objectives and goals will be outlined and states will have the opportunity to share information and work together to ensure uniformity and consistency," Lyle said.

The FDA's Ballinger said the cooperative agreement provides states with the resources to create a multi-year plan to implement a produce safety system, hire staff, develop and provide education, outreach and technical assistance, and create programs to address specific needs of growers.

States and territories that did not apply for funding will have the opportunity to do so in subsequent years of the program, she said in the e-mail. States could apply for funds for education and outreach of their produce growers or seek funds for education, outreach and also inspection work.

Five states applied to receive funds for only education and outreach; most of the states also requested funds for pending inspection work.

The FDA is revising/expanding the original announcement to allow states that only applied for funding for education and outreach to also apply for inspection funds, Ballinger said.

On the same page

Acheson said a key to produce safety inspections will be consistent training across all 50 states to set expectations for compliance.

"We don't want to hear that somebody in New Jersey got nailed for all sort of trivial (issues) and Iowa is getting away with murder," he said. "That is going to cause the industry to get in all sorts of knots and tangles."

In the end, Acheson said cooperation is best.

"I think if it is done correctly, it will absolutely be better for the produce industry than having the FDA guys do it, because at least you will get people who are inherently more familiar with the produce industry than (FDA officials) who have spent their life as a drug inspector," he said.

Ballinger said the FDA is working with states to harmonize inspections, training and education for regulators and growers.

"We have been building the Produce Safety Network to collaborate with states on work planning, provide FSMA and produce safety rule education, perform foreign inspections and foster industry compliance through partnerships," Ballinger said in the e-mail.

The network represents produce safety specialists across the country, she said.

For fiscal year 2017, the FDA requested $25.3 million in added budget authority to implement food safety regulations, $11.3 million of which would be used to support state capacity to assist with implementation of the produce safety rule. However, the agency is still operating under a continuing resolution and Ballinger said it was unclear whether the agency will receive new funds in fiscal year 2017.