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Better enforcement of FDA food-safety guidelines needed

The total value of the fresh produce industry is now worth over $35 billion, up from $15 billion in 2001. Along with this rapid increase in produce has come an increase in food-borne illnesses across the country. Recent data from the Centers for Disease Control and Prevention (CDC) shows that one in six Americans (or 48 million) come down with a food-borne illness each year. Nine million of these cases are attributed to pathogens found on fresh produce.

Since 1998, most of the fresh produce industry has been operating under a voluntary set of Food and Drug Administration (FDA) guidelines, when the agency published its Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables. Keep in mind that the guide was a voluntary list of “best practices and standards” for the produce industry.

Food Safety Modernization Act of 2011
Even though the guidelines were evaluated by third-party auditors, the public was still concerned about the issue of safety. Many in the produce industry went so far as to carry certification showing their compliance with the guidelines. Then, along came the Food Safety Modernization Act of 2011 (FSMA). This act gave the FDA a mandate to pursue a system of checks-and-balances based on science, addressing hazards from the farm to the table.

Signed into law on Jan. 4, 2011, the FSMA was meant to transform food safety, and contains four major provisions.
1. Food facilities must have a written preventative control plan spelling out possible hazards that could affect the safety of their products. Actions taken to prevent or minimize the likelihood of problems need to be written out.
2. The FDA was to establish science-based standards for the safe production and harvesting of produce, including man-made and natural hazards.
3. FDA inspections were to be increased. This also includes the inspection of at minimum, 600 foreign food facilities over a period of five years from the inception of the act.
4. The FDA was given the authority to mandate, or demand a recall of unsafe food if the company would not do it
voluntarily. The FDA was also given the flexibility to suspend registration of those companies associated with unsafe food production.

A couple of the flaws seen in the FSMA’s voluntary model
Let’s go back to the third-party auditors for a moment. Even though the FSMA promised “sweeping changes,” there is still a lot of doubt over the FDA’s ability to carry out the new regulations. The majority of the produce industry is complying with the regulations, and it has produced beneficial results, but serious flaws in the third-party auditing have cropped up.

The biggest flaw involves the lack of scientific knowledge of the fresh produce industry, leading to bias in the audit process. There are no requirements for the construction of facilities or the type of utilities needed. Requirements are lacking for the application of manure, safety standards for irrigation water, the construction of wells, and land use. All these aspects of an operation are just as important as the produce itself and are a major setback to sources of pollution.

The use of water in packing and processing is another source of contamination, especially when it is reused in the washing process. The mechanics behind water-process controls is well understood, but the science behind the use of antimicrobial applications is almost nil. There are no antimicrobial formulations approved by The U.S. Department of Agriculture or the FDA for use on whole fruits and vegetables at this time, even though the agencies have authority to set standards for their use.

Not having an antimicrobial formulation is even more important when looking at the actual farming and harvest part of fresh produce operations. Infectious agents, like Salmonella and E. coli, are easily picked up on fresh produce at the farm level, and can be spread at the packing and processing level. We all are aware of some of the “high-risk” produce easily contaminated in the fields. Think of leafy vegetables, sprouts, and cantaloupes. But, any fruit or vegetable can be contaminated.

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We are deeply saddened to announce the passing of our dear friend Karen Graham, who served as Editor-at-Large at Digital Journal. She was 78 years old. Karen's view of what is happening in our world was colored by her love of history and how the past influences events taking place today. Her belief in humankind's part in the care of the planet and our environment has led her to focus on the need for action in dealing with climate change. It was said by Geoffrey C. Ward, "Journalism is merely history's first draft." Everyone who writes about what is happening today is indeed, writing a small part of our history.

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