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    FDA Docket on Food Safety Standards

    Tuesday, March 23rd, 2010

    Julia Stewart:
    Hello, this is PMA PR Director Julia Stewart, and welcome back to PMA’s audio blog, “Ask Dr. Bob”. PMA’s Chief Science and Technology Officer Dr. Bob Whitaker is with me again today. Bob, we currently have a very unique opportunity to shape the future of the food safety regulations that will govern us. Can you explain to our listeners what is happening and what it has to do with them?

    Sure, Julia. As our listeners may recall, I have spoken about President Obama’s Food Safety Working Group and their focus on upgrading U.S. food safety laws, fostering coordination of food safety efforts throughout the various Government agencies that have responsibility for food safety, and ensuring laws are being adequately enforced. We also discussed the resulting Commodity Specific Guidance which was developed for certain commodities in our industry late last year and how FDA would be looking to expand it in the future.

    Well, now we’re at that point!  FDA has announced they are working on a proposed produce Food Safety Rule with an expected release date of this October.  So, we have a tremendous opportunity for input right at the beginning of the process! FDA has announced the opening of a docket to obtain information about current production and packing practices for fresh produce. They are establishing this docket so that interested parties can provide information and share views to help in the development of safety standards for fresh produce, as well as strategies and cooperative efforts to ensure compliance. FDA will use these comments to develop the proposed rule. It’s great to have the chance to get our comments and input in now while the ideas are still being formulated, as opposed to being re-active once the rule is drafted. 

    What exactly are they looking for, do we know?

    Yes, FDA is inviting comments on a number of critical food safety issues, many of which occupy much of our food safety conversations today. They are seeking input on product testing, food safety auditing, the role the agency should play in produce safety, and the intersection of food safety practices and environmental sustainability among other important issues. FDA is also trying to gather industry’s thoughts on how FDA should measure compliance. You know, it’s one thing to comment on setting standards, but it’s a different prospect altogether to have input into how to feasibly implement and enforce those standards. 

    Bob, do you think the agency pays attention to the comments they receive? We invest a lot of time in developing comments.

    I can tell you, one of the key eye-openers I’ve had in my first 2 years with PMA, is to see how FDA really pays attention to these comments, and how writing them has opened up a dialogue between ourselves and FDA. 

    You know, when I first started at PMA I had several opportunities to comment on various FDA initiatives and guidelines.  To provide substantive – and hopefully helpful – comments takes some thought, and most importantly, time.  I found myself wondering if the time commitment was worth it; I mean was FDA really reading what we were submitting? 

    Well, last summer I had the good fortune to participate in a tour the Center for Produce Safety, set up for FDA officials in California.  The tour was designed to help the FDA folks gain a better understanding of agricultural production and what the industry was doing to improve their food safety practices – but it turned out to be informative for me.  During one of our long bus rides down through the Central Valley, I was speaking with a senior FDA scientist about a number of food safety topics only to have her start reciting back to me some of what I had commented on a few months earlier. This led into a very positive discussion on those comments and an opportunity to expand upon them.  In truth, I think she had a better grasp of what I wrote than what I had!  I became a convert right then and there and I truly believe that FDA does indeed review and consider all the comments they receive. 

    Bob, when is it appropriate for our members to comment?

    Our listeners should check out the Federal Register notice, Volume 75, number 35 posted on February 23, 2010 on page 8086.  Provide comments on those questions or topics where you have experience or a point of view that can give FDA some valuable, constructive input. You can find a link to the Federal Register notice at our food safety page on www.pma.com   

    PMA will be submitting written comments as well, and as always, we appreciate any input you might have for us. Just email me at askdrbob@pma.com.  I’d also like to take this chance to thank those who have offered helpful comments in the past. I greatly value the interaction I have in talking with people around the industry.

    Thank you, Bob, for giving us more background on this important public comment opportunity – and to hear your personal experience that we are in fact being heard.
    Listeners, we do encourage all of you to take a look at the FDA docket and seriously consider submitting some constructive comments that will help them in their process of writing the Proposed Produce Food Safety Rule. Again, for more information on this, go to www.pma.com and look for the food safety page under the Issues tab.

    Thanks to our listeners, and please join us next time!

    GFSI Introduction

    Thursday, March 4th, 2010

    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 and Technology Officer Dr. Bob Whitaker. Bob, in early February you attended a Global Food Safety Conference hosted by the Consumer Goods Forum that was held Washington, D.C. The Consumer Goods Forum sponsors something called the Global Food Safety Initiative. Would you explain to our listeners what GFSI is, and what they’re doing?

    Thanks, Julia. The Global Food Safety Initiative or GFSI was formed nearly 10 years ago by a group of retailers in Europe, to try to bring some cohesiveness to the proliferation of food safety audits. GFSI is a global benchmarking organization that benchmarks different food safety standards or schemes, against GFSI defined set of standards. The goal is to try to bring some equivalency to all the different food safety schemes and audits out there, on a global basis. In effect, GFSI believes that by using a benchmarking approach, the various food safety standards can be equilibrated and brought to a common level.

    Here’s how it works: Their technical group goes through and analyzes each scheme, then reports back on its strengths and weaknesses. If the scheme meets the requirements of their benchmarking guidance, GFSI can then approve or “recognize” the scheme. Alternatively, if they find the scheme to be deficient, or they need further clarification, they can ask the owner of the standard to go back and revise it and re-submit it for future evaluation. The GFSI credo is ‘Once Audited, Accepted Everywhere.’

    Bob, you keep using this word ‘scheme’. What does that mean in this particular context?

    Good point, Julia. In the world of global benchmarking, ‘scheme’ is used to denote an entire food safety program. That is, the technical pieces around risk assessment and management, foundation programs like standard operating procedures, sanitation, good manufacturing practices, training, traceability and also the auditing operations. By auditing, I mean the requirements for auditing the scheme; how the auditor will perform the audit, the requirements for auditing, auditor training, the dispute resolution process, and development of corrective actions.

    SQF 1000 (or Safe Quality Food) and BRC (the British Retail Consortium) are two schemes that have already been recognized by GFSI and are operational in North America. Just last week, GFSI announced that Primuslabs has also successfully achieved recognition.

    So, what happened at this most recent meeting, and why is it significant?

    The most recent meeting in Washington is significant because in North America, we are now broadening our view of standards and what’s going on elsewhere in the world in food safety. GFSI coming to the U.S. for this meeting emphasizes this. The meeting had just shy of 700 participants from all sectors of the food industry — a clear indication of the growing importance of GFSI’s work.

    Also, the discussion at this meeting indicates GFSI is working to address some of the challenges which have been brought up in the past about their approach. The biggest issue revolves around whether they can really reduce the cost of food safety auditing and be relevant to small growers – for example, benchmarked audits so far have been more expensive than other audits. GFSI is recognizing they need to have a system that is accessible to small suppliers as well as large ones. If the higher costs of benchmarked standards exclude smaller suppliers, it may prove to be a major stumbling block for retailers dealing with local growers and seasonal sources.

    Another issue that was discussed at the Washington, DC meeting was that of auditor competency and consistency. No matter what your scheme is, it all comes down to the person who visits your facility and performs the audit. GFSI is committed to working with their approved scheme owners to achieve a higher level of consistency in their auditors’ performance. In the end, in order for buying groups to have confidence that an audit truly represents the food safety performance of their supplier, they must believe that the auditor is conducting audits in an efficient and comprehensive fashion.

    At this point, Bob, why should our listeners care about this?

    Having formal boundaries between scheme-holders, accreditation bodies and certification bodies is something that hasn’t always been the case in the U.S. produce industry. However, this global benchmarking concept is gaining momentum, and a number of companies across the food supply chain are already embracing the concept. Companies like Kroger, WalMart, US Foodservice, McDonald’s and a number of others have said they want their suppliers to adopt a globally benchmarked food safety scheme. Retailers recognize they’re sourcing product globally, and suppliers are increasingly facing a multitude of different audit schemes. Simplifying the audit process worldwide will be beneficial to them.

    It’s also clear that the Food and Drug Administration is looking at, and is willing to work with, folks like GFSI to improve the performance and safety of the food industry. We need to learn about this and be involved with it, because it is a trend we see emerging for our industry.

    Julia:Thank you, Bob, for that interesting introduction to global benchmarking. We’ll look forward to future updates on the topic. Thanks to our listeners, and please join us next time!

    FDA Commodity Specific Guidance

    Tuesday, September 22nd, 2009

    Julia Stewart:
    Hi, this is PMA PR Director Julia Stewart, and welcome back to PMA’s audio blog, “Ask Dr. Bob.” Chief Science Officer Dr. Bob Whitaker is with me today to talk about new commodity specific guidelines currently being developed by FDA.

    Bob, FDA has just recently released the draft Commodity Specific Guidance for tomatoes, melons and leafy greens. So, what does this mean for those commodities and for our industry in general?

    Bob Whitaker:
    Julia, these current actions are rooted in a long history of work by industry to minimize food pathogens in our products. Back in 1998, FDA issued guidance to minimize the risk of pathogen contamination in fruits and vegetables which has now become known as Good Agricultural Practices or GAPs. Later, the industry and FDA recognized there were some crops that seemed to have repeated food-borne illness outbreaks associated with them, like tomatoes, certain types of leafy greens and melons. So the FDA asked the industry to develop commodity specific GAPs to try to identify what it is about those particular crops that makes them more susceptible to outbreaks and what can be done to reduce the likelihood of an outbreak. These three commodity groups worked diligently, with input from FDA, to develop their commodity specific GAPs.

    This July, at President Obama’s Council for Food Safety, FDA officials announced they would be coming out with Commodity Specific Guidance for these three crops, and on August 1 the agency released draft guidelines for tomatoes, melons and leafy greens. These documents should be very familiar to most of the produce industry, because FDA has basically taken the documents industry developed, made some changes based on what we’ve learned recently, and put them out as the draft guidance.

    We now have the opportunity to review and comment on these draft guidelines until November 2, to find where they are weak, overly prescriptive, or don’t make any sense for our industry. PMA is working with commodity groups and members to gather input, and working with other trade associations and regional groups to make sure we properly reflect the industry’s perspective. Then we’ll prepare and submit comments to FDA. Generally, FDA weights these comments and then makes changes where they see fit based on the feedback. This process will take at least a year, maybe two. After the comments are submitted, PMA will most certainly meet periodically with FDA to answer any questions they have and provide any technical information they need.

    Right now, both the GAPs as well as the Guidance FDA is working on are VOLUNTARY. Industry is asked to use these when developing their own food safety programs, and many of the auditing companies use these guidelines as a basis for their audit checklists. However, there is also a lot happening on the legislative front. The Waxman Bill has cleared the House of Representatives, and the Senate will likely take action on food safety legislation this Fall.  This is important because much of what we see as guidelines today could eventually become regulation tomorrow, so we need to follow all of this very closely and carefully. PMA’s government relations blog Field to Fork is a great way to keep on top of what is going on legislatively. You can find them online at: fieldtofork.pma.com

    Thank you, Bob. This is definitely an issue PMA will be watching and updating as things progress. Listeners and readers please do give us your comments. Thanks very much to our listeners, please join us again next time!