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!

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. There is so much happening on the food safety front right now that we decided to do a series of posts about PMA’s government affairs activities in that area.  Bob, I know there’s a lot of ground to cover, so where should we start in this first post?
 
Bob:
Meg, lots of food industry groups are involved in government affairs, so let’s start off by talking about how PMA is different. For many industries, the typical approach to government relations is to be combative, to try to avoid government oversight wherever possible – understandable since past government oversight has often meant more work and cost. But in reality, our industry can no longer expect to avoid government involvement, especially on issues like food safety.  Increased regulation is our new reality, and in fact it may help us restore consumer confidence in the safety of fresh produce. The best way to ensure smart, cost-effective governance of our industry is to work with those who govern us, help educate them about our industry and ultimately develop solutions that work for everybody.

For several years now, PMA has taken a “solution provider” approach, to inform and influence government. We don’t want to walk in the door of an office, say at the Food and Drug Administration, just to complain about some injustice; instead we want to be sure FDA understood the issue. Then we want to offer potential solutions that address FDA’s need to protect public health while at the same time not burden the industry with unnecessary requirements that don’t reflect good science or current industry practices. We view our role not as being there to argue, but rather to inform and influence. It’s a balancing act.

Meg:
So can I ask, how’s that working?

Bob:
We can already point to a number of recent examples when we and our members have told our stories and shared our industry insight – in testimony, during visits to Capitol Hill or different agencies, and in comments submitted about proposed regulations – where we know our voice has been heard and we’ve made a difference in the outcome.

Another difference is our new Government Relations Committee, which met for the first time in January. Its mission includes overseeing PMA’s food safety advocacy work. Members aren’t professional lobbyists – and that’s exactly the point. They’re business people who want to help tell our industry’s story to government, to help inform and influence.

Meg:
So our strategic approach to food safety government relations is to “inform and influence”. How does that manifest itself, exactly?

Bob:
We’ve begun referring to the food safety and technology work we do at PMA as our “practice”.  This practice includes our work in education, such as seminars, symposia, Fresh Connections, and food safety training – in research, for example, our work with the Center for Produce Safety – and in advocacy, that is, working with government affairs, outreach to regulatory agencies like FDA, the Centers for Disease Control and Prevention, the Department of Agriculture and visits to Congress. 

Additionally, our work on government affairs has two distinct components. The first is operational. Our operational work is very member- and industry-focused. What do our members need to know to ensure safe food, and how do we help them deal with current and future food safety rules or requirements? This further breaks down into non-emergency and emergency areas. On a non-emergency basis, we meet with members routinely to listen to and help them when they have problems. On the emergency side, it seems not a week goes by without a call from a member involved in some type of traceback investigation with FDA or a state health department. We can help members interpret testing data, advise them on a course of action, and even help with communications strategies.

Meg:
You mentioned there are two components?

Bob:
Yes, Meg, the second is governmental. Our work with government is really split between working with members of Congress and their staff, and working with the regulatory agencies. We work to improve their knowledge of our industry, and of the science of food safety. Often the information they need is as simple as where particular crops are grown at different times of the year, or how products are harvested and handled. We also extend into microbiology, genetics, and physiology — the science behind food safety.

Related to all this is the interaction we have with the academic community on food safety research. It’s an important bridge between our operational focus in helping members navigate government affairs and our efforts to work with the government directly. By working with the academic community to educate researchers on what our industry does, we can shape their food safety research to yield findings that our members can use to build science and risk-based food safety programs that will improve industry’s food safety performance. At the same time, we can also use this interaction to help ensure the government agencies that fund research, fund the best research.

The Center for Produce Safety in particular has taken on this task of working closely with our funded researchers to help them understand current industry practices and establish working relationships with individual companies, so their work is relevant to our industry.  Time will tell how valuable this approach is, but thus far I believe we are seeing fantastic productivity from researchers, and very effective interaction between the research community and the produce industry.  We will actually feature a session at the CPS’s second annual Research Symposium in Orlando, Florida in June on this interaction between industry and research.  I should also note that CPS has partnered with FDA to hold symposia where research priorities are discussed with industry. This helps complete the circle of academic food safety research, the industry and FDA working together to influence regulations based on science and risk.

Meg: 
Thanks so much, Bob. It is great to see how all these programs are connected and the scope of the work PMA and our volunteers are doing on food safety and government affairs. Next time we’ll talk about our specific areas of activity. Listeners, you can learn more about any of our food safety topics at AskDrBob.pma.com. Thanks for joining us!