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taken the documents industry developed, made some changes based on what we’ve learned recently, and put them out as the draft guidance.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

Julia:
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!

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 Officer Dr. Bob Whitaker is with me today to talk about new developments regarding the U.S. Food and Drug Administration’s food safety guidance to the fruit and vegetable industry. The agency’s voluntary guidance for produce suppliers is called “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables.” It was originally published in 1998 – the agency recently asked the public for comments on how it could update that guidance.

Bob, you wrote PMA’s response to FDA’s request for input on its guide. What exactly did you have to say to the agency?

Bob Whitaker:

Julia, we urged the agency to go beyond good agricultural practices and good manufacturing practices – known as GAPs and GMPs – to instead develop food safety benchmark guidance that could be used to then develop produce-specific food safety standards. Anyone who wants to develop standards, whether in the public or private sector, would then use FDA’s guidance as a framework to develop their standards.

Here’s why we asked for this. We know that our industry’s suppliers are being pressured to comply with more and more food safety standards from all their different customers – and the more standards they have to meet, the more work they have to do and the more money they have to spend. This proliferation of competing standards isn’t necessary, nor is it necessarily helpful in safeguarding the food supply. This is a case where smarter standards would get the job done better.

If FDA would go beyond voluntary guidance like its GAP and GMP guide, and develop mandatory, science-based standards, there would be a lot less confusion and variability in the marketplace. We know our members would appreciate that.

That’s not all we asked for, though. We also urged the agency to then become the agency that would evaluate potential standards against its own benchmarks, and recognize valid standards that meet those benchmarks – or disapprove ones that are found lacking against the benchmarks.

This would be a monumental shift in FDA practice that would catapult the agency from the passive role of just offering voluntary guidance, to actively mandating food safety programs measured by the agency against its own benchmarks. This would go a long way to clarify how to produce fruits and vegetables safely, by reinforcing the importance of risk- and science-based practices across the entire supply chain. That, in turn, would help address the growing wariness that consumers have regarding the safety of fresh produce.

Julia:

Thank you, Bob. I think our members will agree that the approach that PMA has proposed – that FDA become a standards-setting and evaluating body – would help reduce or eliminate the audit fatigue we’re all experiencing, and leave us with better, stronger food safety programs in the end. That’s a goal that all of us can support.

PMA also offered lots of comments on how FDA can update its guide. If you’d like to read PMA’s full comments, then visit PMA.com; look up “food safety” under the issues tab, the comments we submitted to FDA on Dec. 30, 2008, are posted on that page.

Thanks very much to our listeners, please join us again next time!

Hello, this is PMA PR Director Julia Stewart and welcome back to PMA’s audio series, “Ask Dr. Bob Whitaker.” With us today is PMA’s government relations consultant, Tom O’Brien of O’Brien DC, from Washington, D.C. Tom is here to talk about country of origin labeling – also known as COOL. In particular, he’s here to talk about the brand new interim final rule from the U.S. Department of Agriculture regarding COOL for produce and other commodities. Tom, I have two questions for you – first, why is this an interim final rule, and what does that mean? And second, what is the average PMA member going to want to know about what’s in that interim final rule, and what they need to be able to do when it goes into effect on Sept. 30?

Tom O’Brien:
To answer your first question, it’s an interim final rule because the agency’s rulemaking process isn’t over yet. The term “interim” is not that important – what matters is that these rules become law on September 30, and in the meantime that USDA wants to hear what they got wrong and right, and will be accepting comments from us.

And to your second question, here are the basic highlights of the rules on COOL:

• What commodities does it apply to? COOL applies to fresh and frozen fruits and vegetables – the same foods that are covered by the Perishable Agricultural Commodities Act. It applies as well to peanuts, macadamias, pecans and ginseng, and various meats.
• What does origin mean? For produce, it’s simply where the product is grown.
• What commodities are excluded? Processed foods are excluded, and USDA has a very broad definition of “processed.” For example:
• Any two or more substantial commodities combined in a single package is considered processed, and therefore COOL does not apply. A single commodity that is chopped, such as romaine, would need to be labeled, because it is still a single commodity and therefore would have to have COOL information at retail. USDA’s rules take the position that different varieties of a commodity such as red and green leaf lettuce combined together remain a single commodity that must provide the COOL information.
• But if you combine two or more substantial commodities combined in a single package is considered “processed,” and therefore COOL does not apply. A bagged salad mix of lettuce and carrots, or even a mix of chopped lettuce with dressing does not have to have COOL information.
• Processing can take many forms beyond just the combination of several commodities. While chopping is insufficient as I mentioned to make a commodity “processed”, roasting or other processing does remove the COOL obligation, because roasting is a significant process. On the other hand, apple slices that have been treated to prevent browning must be labeled, because it’s still all apples and the anti-browning treatment addition is minor.
• How are the foods to be marked, those that have to have COOL? Fortunately, we have a lot of latitude here, as long as the information gets to consumers – it’s up to us whether to use a sticker, a band, a twist tie, or a label or sign. It is perfectly acceptable to provide the origin information by use of a shipping carton marked with COOL in a display. If you are using a sticker, it doesn’t need to be on every item, just on a majority. Labels that denote the state, region or locality of the produce are satisfactory – for example, “Washington apples” or “Florida Fresh” – are sufficient. This applies to non-U.S. regions as well.
• What about recordkeeping? The key question here is whether the product is pre-labeled. That question determines whether or not there is an obligation to provide origin information. If produce carries the information on its package or a sticker, then no other recordkeeping of the origin is required as that labeled product travels through the supply chain. However, if it not prelabeled, if instead is going to have a store sign created at retail, then the person responsible for initially labeling the product must keep records to prove the truthfulness of the claim, and all others must be able to trace the product back to the originator of the claim.
• If the commodity is not pre-labeled, such as a bulk product, then the COOL information must travel with the product so that the retailer can provide the information to consumers, often by producing a sign. Retailers must retain the origin information ONLY for those items that are not pre-labeled. These records – and they can be bills of lading or other information, and they can be electronic or paper – can be kept anywhere; the retailer is not required to maintain the records at the store.
• What are the penalties for failing to comply? USDA will only impose penalties on retailers if their actions rise to the level of “bad faith”, which it defines as failing to comply after a warning with 30 days to reply. The retailer will first be notified by USDA, then have a chance to correct the problem. Only then can USDA impose fines, and the maximum fine is $1,000 per violation.
• USDA has said, however, that it will spend the first six months on outreach and education about the rules, and will not issue any fines during that time.

Julia:
Thank you, Tom, for that summary. We know COOL is a hot topic with PMA members, as more than 850 sites registered for a Webinar that we held on the rule on Aug. 6.

Our listeners should know that PMA has several resources available to help them implement COOL by the Sept. 30 deadline.

• If you missed the Aug. 6 Webinar, you can listen to a recording of it free of charge, by visiting the COOL resource page at PMA’s Web site. Go to www.pma.com, then to Issues, then to the Country of Origin Labeling page. (Reading this transcript? Go to http://www.pma.com/issues/labeling.cfm.) That’s also where you’ll find USDA’s answers to the questions posed by your peers during the webinar.
• You will also find COOL best practices on that page that were developed by a joint task force of PMA and Western Growers members from across the entire supply chain.
• And finally, we will host a workshop at our Fresh Summit Convention & Exposition in October, by that time we will have lots of feedback on how compliance is going to share with members. For more information about that conference, visit www.pma.com/freshsummit.

We know this is an important topic for our members, and we’re working hard to get you the information you need to make compliance as easy as it can be for you.

Thanks to Tom, very much to our listeners, please join us again next time!