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FDA Compliance

FDA to Set Production Standards for Safer Fruit and Vegetables

Farmers and consumers invited to comment on proposed produce safety regulation

Published: Wednesday, July 13, 2011 - 06:00

As headlines from Europe implicate tainted vegetable sprouts in more than 4,000 illnesses and dozens of deaths, American consumers may wonder, “Could that happen here?”

The United States has had its own headline-grabbing outbreaks from contaminated vegetables—such as lettuce in 2010, peppers in 2008, and spinach in 2006—but a new law has set in motion sweeping improvements to the safety of the U.S. food supply.

President Obama signed the Food and Drug Administration (FDA) Food Safety Modernization Act into law on Jan. 4, 2011, but the year before, the FDA was already gearing up for important work that was mandated by the act: the produce safety regulation.

This regulation will establish mandatory, science-based, minimum standards for the safe growing, harvesting, sorting, packing, and storage of fresh fruits and vegetables. “This will be a monumental shift in food safety,” says James Gorny, Ph.D., senior advisor on safety of fresh produce at the FDA’s Office of Food Safety.

Since 1998, produce growers have had available the “Good Agricultural Practices” issued by the FDA and the U.S. Department of Agriculture (USDA). But this guidance is not an enforceable regulation like the produce safety regulation will be, says Gorny.

Farmers have their say

As part of the regulatory process, the FDA publishes a “proposed rule” and then invites comments to the proposed rule “docket” (public record) online or by mail. Anyone can comment on a proposed rule, and the agency considers all comments submitted to the docket before drawing up the final rule, or regulation. The FDA also intends to hold public meetings about the proposed produce safety rule after it is published, to provide additional opportunities for the public to comment. The agency expects to publish a proposed produce safety rule by spring 2012.

Due to the diversity of produce farms throughout the country—ranging from a few acres to thousands of acres, and growing from a few crops to dozens of vegetable varieties—the FDA decided to reach out to growers before drafting the proposed rule.

In 2010, technical experts, scientists, and other staff from the FDA and USDA went on the road to meet with growers as well as produce industry groups, public policy groups, state agricultural departments, and public health departments in 13 states. They toured farms—both big and small—and talked to the owners. Some of the farm tours were attended by FDA leadership, including Dr. Margaret A. Hamburg, Commissioner of Food and Drugs, and Michael R. Taylor, Deputy Commissioner for Foods. At the invitation of the FDA, Ann Wright,  Deputy Under Secretary for Marketing and Regulatory Programs at the USDA, joined several of the tours, as did a number of state commissioners of agriculture.

“Before we put pen to paper, we wanted to find out what growers are doing now and the food safety challenges they face,” says Gorny.

“It was a refreshing change in the process that was welcomed by the growers and that allowed them to be a part of the process,” says Robert Jones Jr., director of production of The Chef’s Garden, a multi-generational family farm in Huron, Ohio, specializing in sustainably-grown gourmet vegetables for four- and five-star restaurants nationwide and in 12 additional countries.

“The Ohio growers, in general, have a great appreciation and understanding of the necessity of good food safety,” says Jones, who also serves on the board of several agricultural associations in the state. “We have a social responsibility to consumers who purchase and consume the food we grow.”

Several themes emerged from the visits, says Gorny. Many growers commented that produce safety standards should:
• Be appropriate and flexible
• Be science-based and risk-based
• Be practical—not overly burdensome
• Apply to both imported produce and domestic produce
• Be accompanied by a strong education and outreach program

The agency is working to create a regulation that will be flexible and appropriate for both large-farm operators and smaller farmers—including sustainable, organic, and Amish farmers the FDA met when touring the country.

Education and outreach

“One of the themes we heard over and over is ‘educate before you regulate,’” says Gorny.
The FDA doesn’t make produce safer, he adds. “We make the rules that must be followed to keep produce safe. So we need to assist growers with knowledge and training to comply with those rules.”

The FDA is exploring partnerships with state agricultural departments and extension services, produce industry groups, and coalitions such as the Produce Safety Alliance—a collaboration between Cornell University, the USDA, and the FDA—to reach out to growers and provide them with training regarding on-farm produce safety.

Jones says everybody who handles food—growers, packers, transporters, processors, grocers, and consumers—has an important part to play in food safety. “You can educate growers on all they can do in the field—for instance, with water quality and worker hygiene—to lower the likelihood of microbial contamination,” he says. But it won’t be effective unless all the other food handlers practice food safety, too.

The bottom line, says Gorny, is that the FDA wants U.S. consumers to be able to buy healthful fruits and vegetables with the utmost confidence in their safety.


About The Author

FDA’s picture


The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.


Be cautious

It's good to see that more measure are being put into place about the safer treatent and storage of consumables! There's just so many things that can affect us, it's good to be more cautious!