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    PMA Comments for FDA Produce Food Safety Rule

    Julia Stewart:
    Hello, this is PMA PR Director Julia Stewart, and welcome back to PMA’s audio blog, “Ask Dr. Bob” with PMA’s Chief Science & Technology Officer Dr. Bob Whitaker. Bob, hopefully most everyone in our industry is aware that the Food and Drug Administration has been working on developing produce-specific food safety rules. Can you tell us a little more about the most recent action on that front?

    Bob:
    Sure, Julia. You’ll recall that shortly after taking office, President Obama established a Food Safety Working Group and tasked them with focusing on upgrading U.S. food safety laws. One of that group’s recommendations was that FDA should increase its regulation of the produce industry. They looked at the incidence of foodborne illnesses linked to produce, and decided that action needed to be taken to reduce that incidence. Earlier this year, FDA established a docket so interested parties could share views to help in the development of produce-specific food safety regulation. (“Docket” is government-speak for a formal opportunity for the public to provide input to government on a particular topic.) Specifically, they asked what preventive controls could be put in place to avoid contamination of produce by pathogens, since our industry doesn’t have access to viable steps such as cooking to kill microbes that might get on our products. PMA prepared and submitted extensive comments in July.

    Julia:
    Bob, I know you and our members have been working with folks at FDA to educate them on our industry, the particular food safety challenges we face as fresh foods grown under an open sky, and the current state of our industry’s food safety capability. PMA believes the days of fighting government in an adversarial way are gone – in fact, its in our best interests to get the smartest oversight we can get. We look at working hand-in-hand with regulators to help them better regulate us.  So, how do these comments fit into our cooperative strategy, and lead to smarter governance of our industry?

    Bob:
    You’re precisely right Julia. We must work with government to get what we want and need. FDA really is trying to understand where we are on food safety right now, and the best way to move forward. The docket is a tool for them to gather input from various stakeholders around the country.  We chose to prepare comments because it’s a critical time when the agency is reaching out to us for direction in developing controls for the safety of our products that will impact us well into the future.

    Also, as you mentioned, PMA has been very involved in coordinating educational opportunities for FDA staff. For example, Bryan Silbermann hosted FDA Commissioner Peggy Hamburg and her number two Michael Taylor on a tour of farms in the Delaware area last fall. I’ve hosted several tours for FDA and Center for Disease Control and Prevention officials out West, including a tour this spring in Nogales. We hosted several FDA scientists at a program with the PMA-founded Center for Produce Safety, which had an incredible first research symposium in June, we’ve talked about CPS in other blog posts. And most recently, our food safety director Johnna Hepner helped with a field tour for Agriculture Secretary Tom Vilsack.

    There’s nothing more impactful than showing them what we are doing on the ground, every day. All these activities are stepping stones — part of the process of helping FDA create effective and workable rules and standards for our industry.

    Julia:
    Tell us how these comments were developed.

    Bob:
    Our comments document a lot of the things we’ve been saying to FDA over the years. However, this is the first time we’ve been able to leverage PMA’s new volunteer leadership structure, and our new Produce Safety, Science &Technology Committee, chaired by Joe Pezzini of Ocean Mist and vice-chaired by Martin Ley of DelCampo. Staff developed the comments based on our real-world industry experience and with industry input, and then we took them to this committee as a sounding board to ensure they reflected industry needs and interests.

    Julia:
    So what’s notable in our comments?

    Bob:
    There is so much of critical value in them…first and foremost we called on FDA to better define produce-specific food safety standards. This means not only defining the core  aspects of how to design a food safety program, such as beginning with a risk assessment process to drive your program –  but also the more technical and operational elements, such as conducting audits and auditor qualifications. We know that most audits are virtually identical, so the current lack of recognition of audit equivalency is a major issue complicating our industry’s food safety work. FDA has the chance to resolve that.

    Another important theme in our comments revolves around the wealth of food safety data that’s out there, just waiting to be mined for answers.  We specifically suggested that FDA partner with the industry to share their data – for example, we can learn a lot from the information they collect as part of their outbreak investigations.  And the industry can offer our expertise in helping them better understand our processes and mechanisms. We can combine the data that we’re both collecting to better affect food safety.

    The third key theme I want to mention from our comments is that of how to make sure that everyone in our industry fulfills their commitment to food safety. One of the big questions surrounding produce food safety is how to accommodate small and local growers. In our comments we’ve made the case that food safety is completely scalable to any size operation, large and small. From a food safety perspective, it doesn’t matter where the produce comes from; consumers do not expect to be injured in the consumption of a food product. FDA and the produce industry need to and can operate under a common set of expectations regardless of the size or origin of the source production.

    Julia:
    Wow, Bob. Just those few issues will really affect our industry. So, what’s next as far as FDA’s march toward regulation is concerned?

    Bob:
    The next step is for FDA to develop draft regulation for public review. That was originally scheduled to be published in October of this year, but now it looks like it won’t be coming out till 2011. They’ve recognized the complexity of our industry and the enormous amount of crucial issues which must be addressed. After the draft rule is published, we’ll get another chance to provide comments on it and work with FDA. This is very much a give-and-take between the industry and the agency.

    Julia:
    Thank you Bob.

    Listeners, you can read PMA’s preventive controls comments by visiting the PMA website; go to PMA Resources, then Government Relations, then Regulatory Interaction – and look for our comments to FDA dated July 23, 2010. We’ll also include a link in the written version of this blog post.  These comments cover a lot of other significant issues in our comments, and I encourage you to take a look at the full document. I’m sure some of our future posts will cover other specific issues mentioned in our comments. 

    Until next time, thanks for joining us!

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