Meg:
Hello, this is PMA public relations manager Meg Miller, and welcome back to our audio blog, “Ask Dr. Bob” with PMA’s Chief Science & Technology Officer Dr. Bob Whitaker. In recent posts, Bob and I talked about how PMA plans to generally approach the Obama administration’s implementation of the new Food Safety Modernization Act. The Food and Drug Administration is now charged with translating the law into implementing regulations. In those posts, we talked about the different approach that PMA takes to government relations, striving to collaboratively work with government, to inform and educate their work so that we get the best governance possible.

In this post we’re going to look at a specific component of FSMA – its mandates regarding traceability – and discuss what FSMA implementation may mean for the industry’s ongoing Produce Traceability Initiative.

Bob, can you start by giving us the basic 411 – what does FSMA have to say about traceability?

Bob:
Meg, as we talked about in those earlier posts, the FSMA law is basically a blueprint. Congress provided general direction, and now it’s up to FDA to build regulations that define the specifics to implement that general direction. At this point in time, it’s not possible to say exactly what the implementing regulations will look like.

The law’s traceability component provides a great example of what we know, and what we don’t know for now. For example, FSMA calls for better traceability of foods in general, and heightened recordkeeping for so-called “high risk” commodities. Well, it will be up to FDA to identify the commodities it deems to be “high risk” (though we can probably make some well educated guesses.) As for the recordkeeping system, the law also specifies that FDA will develop a system to “effectively and rapidly” trace and track food – it will be up to FDA to determine what such a system might look like. 

The good news is, the law specified that those additional recordkeeping requirements must be science-based – Meg, you and our listeners know that PMA is always advocating for food safety decisions that are based on sound science, and that are prioritized based on the risk posed by a particular food.

In terms of what else we know at this point, the law also provided FDA with some instructions to undertake before deciding what traceability and recordkeeping systems should look like.  The law requires that there be a produce-specific pilot program, and that FDA evaluates the costs and benefits of traceability solutions that are already available.

Meg:
I know some members have asked whether they should wait for those final implementing regulations before moving forward with implementing the Produce Traceability Initiative. What are your thoughts on that?

Bob:
There are several reasons why they shouldn’t wait. First, it’s going to take several years before implementing regulations are developed and go into effect. In fact, the law lays out some ambitious timelines that we think are going to be difficult to achieve. In the meantime, our industry simply can’t afford to wait that long to begin the work of building traceability systems that can minimize the scope and severity of recalls.  We know these recalls are expensive for our members.  We also know that we need to start restoring consumer confidence in the safety of our foods that has been battered by a series of high-profile foodborne illness outbreaks in recent years. PMA research indicates that consumers are not increasing consumption in part because of food safety concerns. 

Second, as Ed Treacy – my colleague who directs PMA’s supply chain efficiency efforts including the PTI – recently wrote, if altruism doesn’t sufficiently motivate you, then consider that we’ve also gotten the legal community’s attention. These days, a foodborne illness outbreak is at the very least expensive and in some cases could well cost you your business, and that’s a price no one wants to pay. We need a better system now.

I think it is also important to note that the buying side of our business is busy at work implementing traceability programs – and for all fresh foods, not just produce.  We have seen tremendous support for PTI from leading retail and foodservice buyers.  It is going to be important for suppliers to be able to demonstrate that they too are working to meet PTI timelines and have the systems in place to provide for sufficient traceback should the need arise. 

As we talked about in the earlier posts about PMA’s approach to food safety government relations, our strategy is to inform and influence their work and collaborate with those responsible for governing us so that we get workable solutions to our needs. We’re planning to apply that strategy to outreaching to FDA on FSMA implementation.  The industry has already developed a working, efficient, cost-effective traceability solution in the Produce Traceability Initiative, we’re going to make the case early and often that FDA doesn’t need to look any further than that.

Meg:
Am I remembering correctly that the law specifically doesn’t require case-level tracking, which is a key component of the PTI?

Bob:
That’s right, but I wouldn’t read a whole lot into that right now; the law also didn’t prohibit case-level tracking, nor did it mandate item-level tracking. The industry steering committee that developed the PTI back in 2008 settled on case-level tracking after looking at all the available options, and determining case-level tracking to be the most efficient, effective way to achieve the goal of whole-chain traceability. We think FDA will come to the same conclusion after looking at the matter themselves.

For example, we know from public comments that FDA official have made that the thing about traceback investigations that is giving them the most trouble is the lack of a common identifier as a food moves through the supply chain. They’ve also complained about the inconsistency of recordkeeping from company to company, and the amount of time it takes to access those records. The PTI addresses all of those concerns by establishing a common product identifier – the Global Trade Item Number or GTIN – and with standardized, computerized recordkeeping.

Meg: 
Thanks, Bob. We’ll look forward to talking with you more about PMA’s work on FSMA implementation in future posts as that work gets underway. Let’s stop there for today, since I know we’re going to have Ed Treacy join us in the near future to give an update on the PTI.

Listeners, if you’d like specifics on the Food Safety Modernization Act – including a paper that covers more of the details on what it means for the PTI – please check out the PMA Resources section on PMA’s website on the Government Relations page.  You’ll also want to check out our new online Food Safety Resource Center there. And for more information regarding the Produce Traceability Initiative, including tools to help you implement it within your company, visit the PTI website at www.producetraceability.org. Thanks for joining us…until next time!

Meg:
Hello, this is PMA public relations manager Meg Miller, and welcome back to our audio blog, “Ask Dr. Bob” with PMA’s Chief Science & Technology Officer Dr. Bob Whitaker. This is the third, and last, post in a series on PMA’s government affairs activities in the food safety area. In the previous post, Bob told us much of his effort over the next few years will be spent on implementation of the new food safety law. Bob, why is the rulemaking process so important?

Bob:
Meg, the law is basically a blueprint. Now it’s up to FDA to build regulations to fit it. We can break the process into two areas: pre-rulemaking and rulemaking.  Pre-rulemaking is the period before the agency publishes a proposed rule, when it can talk freely with industry. We’re in this period now and we need to interact as much as possible with FDA.  We’ll be focusing on one-on-one meetings with FDA to discuss key issues within the legislation. We’ll use these encounters to put forward our member’s position on specific issues, and then offer ideas on how FDA might accomplish its goals in a way that considers industry’s needs. 

We’ll also use combined PMA committee meetings that will be held in Washington, D.C., in June 2011.  We have three PMA committee meetings happening simultaneously at this time: the Produce Safety, Science & Technology, the Government Affairs and the Supply Chain Technologies Committees. They’ll work both together and separately on key food safety issues.  We’ll harness all the expertise assembled to make government decision makers aware of issues we may have with aspects of the current bill, and to enhance our ability to influence the rulemaking process.

We’ll also leverage the Center for Produce Safety’s credibility to affect rulemaking, including pushing for more produce-specific research funding to better define food safety measureables. CPS’s role is bigger than just providing input on rulemaking. Produce-specific food safety research has not historically been a government priority, so the rulemaking process gives us an opportunity to elevate the role of research with FDA.

Meg:
Now, once the rulemaking process officially begins, the environment will change, right?

Bob:
That’s right. At that point, the agency cannot discuss anything related to its implementing regulation work with any stakeholders. At that point, FDA will only be able to receive input through formal channels related to the rulemaking process, including any public hearings it might hold, and the public comment process. Our focus will then turn to providing written comments, participating in hearings, and encouraging our members to do the same. 

I think this is where PMA can be especially effective.  We can leverage our volunteer committees to provide FDA with comprehensive, supply chain input on key facets of the food safety rules, and help shape the direction of those implementing regulations.

Meg:
Are there particular parts of the legislation that we’re planning to focus on?

Bob:
Definitely. There are some parts of the legislation that PMA won’t be able to influence at all because FDA will address them internally. There are other parts we can probably influence somewhat, and then there are still other parts that we think we’ve got lots of room to work on.

Parts we consider included in the “not much room to influence” bucket include the law’s sections regarding access to record, registration, and the small and local farms and facilities exemption that we couldn’t support. Our main concern there is that we feel exemption could limit market opportunities for small growers who become exempt.  It’s important to remember, in addition to  government regulation, there are also marketplace pressures, such as food safety standards set by buyers – and ultimately the marketplace holds the hammer, so the marketplace really decides who gets to sell their products to whom. With all the focus on food safety, product liabilities and brand protection, it is increasingly hard to see any buyers wanting to source products from a company that doesn’t have a food safety plan. Having said that, PMA is committed to helping exempt growers that still want to have market access and develop food safety programs. In fact PMA has been conducting local and smaller grower food safety training seminars around the country to help growers develop food safety programs.

The “more room to work” bucket includes the law’s requirements regarding laboratory accreditation and testing, importer verification of foreign suppliers, fast track entry, accreditation of third-party auditors, FDA inspections, foreign inspections, and recall and outbreak response. The law’s requirement that food be tested and testing laboratories be accredited is certainly an important area for us. Anyone who has listened to our posts on product testing knows that there are complex issues surrounding the question of testing. As producers of perishable products, we’re very aware of the market impacts of anything that slows our products getting to market. So, issues of perishability, timing and who gets the test results will be front and center in this discussion. The rules for third-party auditors to inspect foreign facilities will be another big change for our industry.  And, FDA’s beefed-up recall authority will present issues of implementation and cooperation.

As for where we’re hoping to have significant room to provide input and guide FDA’s rules, those include the areas of food safety plans, produce standards, traceability and recordkeeping, and posting of recalls.  We’ll want emphasize some guiding principles with FDA as they look at requirements for food safety plans and produce standards.  We’ll also want to make sure to provide input on the traceability and recordkeeping requirements, and closely monitor how any new rules fit with the Produce Traceability Initiative. These areas, as well as how recall notices get posted at grocery chains, are all areas where PMA and our industry can work as a “solution provider” with FDA.

Meg: 
Wow! It’s quite the task we have ahead of us, Bob. Listeners, if you’d like specifics on the Food Safety Modernization Act please check out the PMA Resources section on PMA’s website for the Government Relations page.  You’ll also want to check out our new online Food Safety Resource Center there. Thanks for joining us…until next time!

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!