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!

Meg Miller:
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 second of a series of posts about PMA’s government affairs activities in the food safety area. In our last post we discussed PMA’s “solution provider” approach, to inform and influence government. This time, let’s talk about where PMA focuses its energies on food safety and its government affairs work.

Bob:
We’ve got a lot of exciting stuff going on, Meg, but one thing we place a priority on is providing written comments to the Food and Drug Administration. I’m talking about when FDA publishes notices in the Federal Register requesting comments to help inform their work, or about a proposed regulation. I have to admit I used to be skeptical about the value of written comments. When I first joined PMA, there were several different opportunities to prepare comments, and I have to say I thought it was a waste of time.  I didn’t think FDA really paid much attention to what we had to say. Boy, was I wrong! 

What I found was that FDA didn’t just read PMA’s comments, they valued them and used them. In fact one time I encountered an FDA person at a professional meeting who actually had PMA’s comments with them and had been reviewing them on the airplane on their way to the meeting.  This person had made handwritten notes on them, and it really struck me how seriously FDA takes these comments and how impactful they can be.

Our efforts in writing comments, along with some “get to know you” meetings that we had at FDA right after I started at PMA, have also led to other ways we interact with FDA. These include conducting field tours for regulators, and making phone connections – that’s what I call fielding those phone calls from FDA when they have questions on industry practices or food safety science questions. This work also includes what we at PMA sometimes refer to as “wise-person” visits – where we’re invited by FDA to spend time with staff to answer their food safety questions, on topics ranging from scientific issues to industry practices and enforcement. 

Our approach as a “solution provider” – combined with our staff’s scientific and industry expertise and our members’ boots-on-the-ground expertise – have well positioned PMA to impact key FDA activities pertaining to produce safety.  And I can’t stress enough how helpful our members’ involvement is, whether they are testifying at a hearing or meeting, or participating in field tours, visiting their congressional staff, or giving us input on comments we plan to submit.

Meg:
So what do you see coming?

Bob:
Our focus over the next few years will be to influence implementation of the new federal food safety law of the land – the Food Safety Modernization Act – as much as possible. PMA supported this bill when it was first introduced because we believed produce-specific legislation was needed to level the playing field for everyone in our industry, and to help restore consumer confidence in the safety of fresh produce. (Meg, you’ll remember we had to withdraw that support late in 2010 after exemptions were added that we thought were counter to food safety.)

Now that the bill has been enacted into law, our attention shifts to FDA, which is charged with developing regulations to implement the new law. If this was a football game, we’d basically midway through the second quarter. The industry has asked for regulation, Congress has responded with legislation and the President has signed it into law. FDA is analogous to the coaching staff that is now gathering information and getting ready for the second half. In our case, this second half includes the pre-rulemaking stage, the rulemaking process, and then getting the rules implemented.  Our goal will be to get regulations that will work as well as possible for our industry, and to help grow our markets, not limit them.

Meg: 
So next time, let’s talk about our game plan for those different stages. Listeners, if you’d like more information about the Food Safety Modernization Act, you can find some great resources on PMA’s website, www.pma.com, in the Resources section – look for the Government Relations page. If you have specific questions on food safety issues, please email Dr. Bob at AskDrBob@pma.com.

Thanks for joining us!