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Archive for August, 2011

FDA Tells Farmers: We need to learn from you

August 20, 2011 59 comments

Michael R. Taylor, FDA and Bob Nolan, Deer Run FarmsMichael R. Taylor, FDA and Bob Nolan, Deer Run Farms
Photo taken by Erica Pomeroy

Last week, farmers from across the North and South forks of Suffolk county Long Island showed a group of us from the U.S. Departments of Agriculture and Health and Human Services, the Food and Drug Administration (FDA), and the New York State Department of Agriculture and Markets the incredible diversity of their farms and the challenges FDA faces in writing a “produce safety” rule.

Bob Nolan, who farms 30 acres with his son and uncle, invited us because he heard that we had walked the rows of other fresh fruit and vegetable farms across the country.  In fact, this was the 14th state we visited in the last year or so.  We have seen the orchards of Oregon, the vast vegetable fields of California, Amish farms in Ohio, irrigation-dependent produce operations in Texas, vegetable farms in Delaware, North Carolina family farms, and Florida tomato fields to name just a few.

And each time, we have come away with new insights from the farmers and their families about how they are already addressing produce safety concerns, what they expect from an FDA rule, and the challenges of maintaining their way of life.

Our Long Island tour was a microcosm of the diversity we have seen across the country.  Organized by Cornell extension agent Sandy Menasha and Long Island Farm Bureau executive director Joe Gergela, the tour of seven farms ranged from small to large, conventional to organic, first-generation farmer to twelfth generation.

Let’s face it, the first question a federal official gets asked on a farm is as blunt as the summer day is long: Why are you here?  Mike Taylor, the FDA deputy commissioner for foods, has a pretty good answer: If we’re going to get this produce safety rule right, we need to learn from you.

That’s it in a nutshell.  While FDA and its colleagues at USDA bring to the table scientific and public health expertise, we all know that farms are very much the real world of soil, air and water open to the elements 24/7 and worked by humans and animals.  Farmers can inform us from their experience and practices.

Just see the different perspectives shared with us last week: the first-generation organic farm of the Garden of Eve; the 225-acre Ed Zilnicki and Sons’ potato farm; Nolan’s 30-acre Deer Farms devoted to leafy greens; the “agritainment” and “u-pick” farms like Hank’s Pumpkin Town, Harbes’ Family Farm, and the Milk Pail; and the farm stand run by Jim and Jennifer Pike.

And we got to hear loud and clear what the farmers expect from the FDA.  “I can’t hire a food safety guy. I am the food safety guy,” Bob Nolan said.  Hank Kraszewski wants the produce safety rule to be “crystal clear.”  Tell farmers straight out, “What do I have to do,” he said.  Record-keeping can’t become burdensome for small farmers like themselves, Eve Kaplan-Walbrecht and Jim Pike told us.

Farmers are also thirsty to learn more.  Horse manure is a time-honored soil amendment for the sandy fields of Long Island.  How can they apply it safely, they want to know.

And, while we heard that while farmers get it about food safety, they also want us to get it about the economic realities they face.  Several had struggled in the ‘90s when wholesale potato farming became less profitable and they moved to other commodities and on-farm retail sales.

Successful produce safety is possible if farmers and food safety officials work together, listening to each other and learning from each other.

Sharon Natanblut, Senior Advisor to the Deputy Commissioner for Foods, FDA

Fostering Innovation Through Better Science

August 17, 2011 21 comments

Science is the backbone of everything we do at FDA.  Which is why today’s release of the agency’s Strategic Plan for Regulatory Science is a significant next step in the agency’s Regulatory Science Initiative, originally announced in October, 2010.  We are releasing the plan along with a podcast and a consumer article to make it easier for everyone to join this conversation about regulatory science and understand what this plan really means.

“As new discoveries yield increasingly complex products,” says FDA Commissioner Margaret A. Hamburg, M.D. “this strategic plan ensures that our experts are equipped to make science-based decisions resulting in sound regulatory policy.  It positions us to foster innovation through better science without compromising our high safety standard.”

This plan calls for a sweeping modernization of the science used in developing and evaluating products critical to the nation’s health, economy and security.  It recognizes the important role the agency must play in fostering innovations in the marketplace today to address the public health challenges of tomorrow.                       

All around us we see evidence that new technologies are creating unprecedented opportunities to prevent and cure disease as well as to grow our high tech economy.  As my colleague and FDA’s Chief Scientist Dr. Jesse Goodman says:  “This plan will help turn advances in science into products that benefit people, and help FDA assure that happens more quickly and safely.  It is win-win-win, because it will help the public, the agency and developers of new products.” 

This plan signals clearly the agency’s intent to work collaboratively with our colleagues in academia and industry to enhance the process for developing and evaluating promising new products and novel materials emerging from fields such as cell therapies, tissue engineering, genomics and personalized medicine, and through use of advanced computing and information technology.  

As we move forward, we welcome ideas and comments.  We are inviting our partners, domestic and international, and the public to join the conversation as we take the steps necessary to advance and target the best regulatory science to help meet the nation’s highest public health priorities and medical needs.

Thank you.

Vicki Seyfert-Margolis

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