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!

Hello, this is Julia Stewart and welcome back to PMA’s new audio series, “Ask Dr. Bob Whitaker.” Today I am talking with Kathy Means, PMA’s vice president of government relations and public affairs. She and Bob Whitaker form the dynamic duo that heads PMA’s food safety team.

Kathy, an Associated Press reporter recently asked you if the tomato traceback process would be going faster if mandatory country of origin labeling was already in place. Would you please share with our audience how you responded to that question?

Kathy Means:

While at first glance one might think that logic seems to make sense, in fact country of origin labeling would not speed the traceback – which makes sense when you think about your own produce consumption.

Bob has talked a bit about how difficult epidemiological investigations can be a previous briefing. Let’s imagine you ate something that made you sick. It may take up to three days for you to get sick. Then you’re sick for a few days before you see the doctor, and then the tests they do take another week or so.

So by the time the public health folks get to you, they are asking you what you ate over the course of three days two weeks ago — try it now, can you do it? Think about everything you ate June 2nd, 3rd and 4th – what you ate, where you ate it, et cetera. Write it all down. Now, can you also remember the sticker on every fresh produce item you bought – and remember, country of origin labeling only applies to the produce you bought at retail, not at foodservice. And also remember, you may have bought the produce earlier than June 2nd, 3rd and 4th. It’s tough, isn’t it?

The goal of country of origin labeling is to inform consumers at point of sale – it’s not a food safety tracking system. What’s key in a traceback is the information the buyer has about where it sourced its products. As a consumer, you may remember that you bought your produce at Store A and/or Store B. And you may remember that you ate out at Restaurant X, a graduation party and a community pot luck. Then it’s up to the retailers and foodservice operators to work with public health officials to trace back all of those points of service. It’s not up to you as a consumer.

What’s important for traceback is that everyone in the industry must know and be able to document where they got the product from and whom they sent it to – one up, one back – as required by the federal bioterrorism law. It’s also important that this process be quick and efficient – that’s why PMA is so strongly behind the ongoing industry-wide traceability initiative we are leading with United Fresh Produce Association and the Canadian PMA.

But even when all of that is in place, traceability may hit a snag when products are commingled and repacked, as they often are in the case of tomatoes and other items. This is one example of a practice we’ll all have to take another look at in the future.

So if country of origin labeling is not a food safety system, what is it? It is a way to let consumers know where their produce was grown – and for a lot of producers, it’s a marketing opportunity they can use proudly. Right now the top 20 fruits and top 20 vegetables make up more than 90 percent of the fresh produce sold to consumers at retail in the United States. And more than 60 percent of them have some sort of origin information – might be a country or a U.S. state or region. So we’re already well on our way to providing consumers with the information that the law will require us to do when country of origin labeling becomes mandatory starting this fall.

Julia:

Thank you, Kathy. To help our members get ready for the September 30 start date for mandatory country of origin labeling, PMA and Western Growers will be hosting a free Webinar June 24. The Webinar will introduce best practices developed by a task force made up of industry leaders from across the supply chain. For more information about the Webinar, or to access the best practices, please go to our Web site www.pma.com, and then to our country of origin labeling issues page. Remember, the June 24 Webinar is free, but you do have to register, so please register today.

Thanks for listening. Please join us again next time!