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!

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!

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 and Technology Officer Dr. Bob Whitaker is with me again today. Bob, we currently have a very unique opportunity to shape the future of the food safety regulations that will govern us. Can you explain to our listeners what is happening and what it has to do with them?

Bob:
Sure, Julia. As our listeners may recall, I have spoken about President Obama’s Food Safety Working Group and their focus on upgrading U.S. food safety laws, fostering coordination of food safety efforts throughout the various Government agencies that have responsibility for food safety, and ensuring laws are being adequately enforced. We also discussed the resulting Commodity Specific Guidance which was developed for certain commodities in our industry late last year and how FDA would be looking to expand it in the future.

Well, now we’re at that point!  FDA has announced they are working on a proposed produce Food Safety Rule with an expected release date of this October.  So, we have a tremendous opportunity for input right at the beginning of the process! FDA has announced the opening of a docket to obtain information about current production and packing practices for fresh produce. They are establishing this docket so that interested parties can provide information and share views to help in the development of safety standards for fresh produce, as well as strategies and cooperative efforts to ensure compliance. FDA will use these comments to develop the proposed rule. It’s great to have the chance to get our comments and input in now while the ideas are still being formulated, as opposed to being re-active once the rule is drafted. 

Julia:
What exactly are they looking for, do we know?

Bob:
Yes, FDA is inviting comments on a number of critical food safety issues, many of which occupy much of our food safety conversations today. They are seeking input on product testing, food safety auditing, the role the agency should play in produce safety, and the intersection of food safety practices and environmental sustainability among other important issues. FDA is also trying to gather industry’s thoughts on how FDA should measure compliance. You know, it’s one thing to comment on setting standards, but it’s a different prospect altogether to have input into how to feasibly implement and enforce those standards. 

Julia:
Bob, do you think the agency pays attention to the comments they receive? We invest a lot of time in developing comments.

Bob:
I can tell you, one of the key eye-openers I’ve had in my first 2 years with PMA, is to see how FDA really pays attention to these comments, and how writing them has opened up a dialogue between ourselves and FDA. 

You know, when I first started at PMA I had several opportunities to comment on various FDA initiatives and guidelines.  To provide substantive – and hopefully helpful – comments takes some thought, and most importantly, time.  I found myself wondering if the time commitment was worth it; I mean was FDA really reading what we were submitting? 

Well, last summer I had the good fortune to participate in a tour the Center for Produce Safety, set up for FDA officials in California.  The tour was designed to help the FDA folks gain a better understanding of agricultural production and what the industry was doing to improve their food safety practices – but it turned out to be informative for me.  During one of our long bus rides down through the Central Valley, I was speaking with a senior FDA scientist about a number of food safety topics only to have her start reciting back to me some of what I had commented on a few months earlier. This led into a very positive discussion on those comments and an opportunity to expand upon them.  In truth, I think she had a better grasp of what I wrote than what I had!  I became a convert right then and there and I truly believe that FDA does indeed review and consider all the comments they receive. 

Julia:
Bob, when is it appropriate for our members to comment?

Bob:
Our listeners should check out the Federal Register notice, Volume 75, number 35 posted on February 23, 2010 on page 8086.  Provide comments on those questions or topics where you have experience or a point of view that can give FDA some valuable, constructive input. You can find a link to the Federal Register notice at our food safety page on www.pma.com   

PMA will be submitting written comments as well, and as always, we appreciate any input you might have for us. Just email me at askdrbob@pma.com.  I’d also like to take this chance to thank those who have offered helpful comments in the past. I greatly value the interaction I have in talking with people around the industry.

Julia:
Thank you, Bob, for giving us more background on this important public comment opportunity – and to hear your personal experience that we are in fact being heard.
Listeners, we do encourage all of you to take a look at the FDA docket and seriously consider submitting some constructive comments that will help them in their process of writing the Proposed Produce Food Safety Rule. Again, for more information on this, go to www.pma.com and look for the food safety page under the Issues tab.

Thanks to our listeners, and please join us next time!