FDA regulations grow fresh demands for Delaware farmers

By Christi Milligan

The University of Delaware Cooperative Extension has incorporated the impact of FSMA into their workshops and educational materials.

The University of Delaware Cooperative Extension has incorporated the impact of FSMA into their workshops and educational materials.

David Marvel Jr. just finished planting nearly a quarter of a million watermelon seeds on his family’s Houston, Delaware, farm. August should bring both the harvest and news about federal regulations that could impact the future of his 106-year-old operation.

The Food Safety Modernization Act (FSMA) is the most significant overhaul of the food safety guidelines since the 1930s. Signed into law by President Obama in 2011, the regulations focus almost solely on preventive measures throughout the fresh-food supply chain.

It also marks the first time the U.S. Food and Drug Administration will be given the authority to enforce food safety regulations it’s charged with promulgating —everything from food handling practices on the farm to product recall at the store.

Complete FSMA regulations for fresh produce won’t be published until August, but officials already anticipate what it will mean for a number of Delaware’s major fruit and vegetable growers: additional paperwork, mandatory third-party audits, and an overall grasp of the “farm to fork” rules aimed at preventing food-borne illnesses.

“The fact is that a lot of things the FDA is going to be requiring we’ve been educating (about) for a long time,” said Professor Gordon Johnson of the University of Delaware Cooperative Extension. “The difference is it’s now going to be regulated.”

For large farming operations, third-party audits are simply the cost of doing business with grocery store chains, restaurants, and wholesalers that demand proof of Good Agriculture Practices (GAP). But FSMA could be a tipping point for smaller to midsize farmers who don’t regularly use third-party audits. FSMA regulations include steps to prevent hazards related to animals, workers, and water sources.

According to Johnson, anything that improves food safety is a good thing. But he conceded the federal regulations could be an added burden, particularly to small and midsize farming operations. Still, the Cooperative Extension program has been intentional about including both GAP and Good Handling Practices in its education of and partnerships with Delaware farmers.

“Over the last 20 years there’s been so much additional regulation — progressive folks realize it’s the cost of doing business,” said Johnson. Delaware is home to roughly 150 to 200 fruit and vegetable producers; many of them sell to wholesalers who Johnson said are driving the FSMA initiative to mitigate the risk of selling produce that might contain bacteria.

(It was a 2006 outbreak of E. coli from bagged spinach that originated from a single farm in California that spurred regulations and education. More than 200 people across the U.S. were sickened and three people died.)

Department of Agriculture Secretary Ed Kee said the industry knows the regulations are coming and the challenge will be implementation.

“The impact of regulations will unfold in two ways,” said Kee. “The farms that do all those things will see this as a way to ensure their relationship and credibility with their customers by showing they’re a good supplier and high-quality vendor.

“The midsize to smaller farmer may decide to stay small or get out because he can’t step up to the plate for all these regulations.”

Marvel said he worries he might fall into the second group. Third-party audits can cost nearly $1,000, but the ensuing compliance and paperwork generate the real headaches and expense. Kee said he knows of large farms that have spent upward of $100,000 in compliance for paperwork and audits.

“We might be at a crossroads,” said Marvel, who also grows sweet corn on the 140-acre farm. “Dad is 67 and he doesn’t want to deal with any more paperwork. Liability is the issue. You can do everything right and still be wrong.”

Curt Fifer grows fresh produce on his farm in Wyoming, Del.  Annual third-party audits are an integral part of his business relationships with area grocery stores.
Curt Fifer grows fresh produce on his farm in Wyoming, Del. Annual third-party audits are an integral part of his business relationships with area grocery stores.

Curt Fifer is a fourth-generation farmer with 2,000 acres in Wyoming, Delaware. He grows a wide variety of vegetables and fruits, including asparagus, strawberries, peaches, and brussel sprouts. Fifer regularly pays nearly $1,500 annually for a third-party GAP audit so he can sell to Delaware restaurants, grocery store chains, wholesale middlemen, and just about “everyone you can think of.”

“It does change the way you start doing things on the farm,” he said. While he said he can afford the audits, compliance is costly. Fifer estimates he’s spent nearly $100,000 in the last eight years on capital improvements, and he can easily recite the list of projects and materials he’s purchased: a Global Food Safety Initiative number ($5,000) to meet traceability requirements, stickers for the labels ($3,000), and a printer ($1,000) to produce them.

He’s also built a cart to transport a Porta Potty and sink in his fields. “Our spray shed had to be nonflammable, so we had to line our whole shed with metal,” said Fifer. “It looks beautiful, but that cost us $8,000.” This year he’ll spend $5,000 on a food safety consultant in preparation for the annual audit.

“We have no choice,” said Fifer. “I sound like I’m complaining but I understand why it’s being done. At the end of the day, it’s making farms safer.”  But Fifer said he doesn’t understand the need for FSMA, citing the potential for overlap.

“For most growers in the industry, if they’re doing food safety audits, then they’re already doing what FSMA is asking,” said Fifer. “And if small growers are exempt, then I think it’s a waste.”

“It’s about record keeping and documenting,” said Kee, who praised the FDA for extended public-comment periods and its initiative in partnering with states and the farming industry. “But at some point, you do have to ask, ‘Is this regulatory overkill?’”

Kee said he thinks there will be some sort of contractual relationship and funding for the regulatory programs mandated by the FDA. Delaware could hire up to four or five employees to oversee compliance.

The Produce Marketing Association (PMA) is a trade organization with global reach in the fresh produce and floral supply chain. Jim Gorny, vice president of food safety and technology for PMA, said the regulations represent a sea change for food safety.

“It’s turning audits from a ‘thou should’ to a ‘thou shall’ regulatory requirement,” said Gorny. But Gorny cautioned that federal and state audits should be harmonized to avoid redundancy and to save money.

President Obama has asked for a $109.5 million increase to the federal budget for FSMA implementation. The FDA has proposed $11.5 million toward education and technical assistance for the food industry impacted by FSMA.

“Food safety is like stop signs,” said Gordy. “It benefits the pedestrian and the driver. And so it should be paid for by the federal government.” Gordy agreed that large farming operations will not notice a big change with the release of FSMA. But mom-and-pop operations might.

“It may be a mechanism that avoids some outbreak-related food-borne illness,” said Kee. “Having said that, in my career I don’t know of any outbreak that has happened in Delaware from fresh fruits and vegetables grown by a Delaware farmer.”

What farms could be impacted by FSMA?
The Food Safety Modernization Act includes regulations of the following areas:

1. Produce Safety — Establishes standards for international and domestic produce growers focused on growing, harvesting, packing, and holding of produce on farms.

2. Preventive Controls for Human Food — Sets standards for firms that manufacture, process, pack, or hold human food.

3. Preventive Controls for Animal Food — Improves safety of animal feed by preventing its adulteration.

4. Foreign Supplier Verification Programs — Addresses import safety; closely tied to the preventive controls and produce safety requirements.

5. Third-Party Accreditation of Auditors — Establishes a comprehensive, credible, and reliable program of oversight based on third-party audits and certification of foreign food facilities to aid FDA.

6. Mitigation Strategies to Protect Food against Intentional Adulteration — Requires that the largest food businesses in the U.S. prevent FDA-registered food facilities from being targeted by intentional attempts to contaminate food supply.

7. Sanitary Food Transportation — Requires certain shippers, receivers, and carriers that transport food consumed or distributed in U.S. to take steps to prevent the contamination of human and animal food during transportation.

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