Transcripts For CSPAN Food Safety Modernization Act 20140222

Interested in, will we have any musical entertainment . I can assure you if you do not come, your spouse will be saying i cannot believe you missed that. I am limited about what their agents will let us say. Contract. Nder a i can promise you this. We will have several entertainers that you will say wow, i cannot believe it got to be in a small group and listen with them. You can swing by the most visited National Park in the country or head west and go see memphis your room is our that elvis is still in the building at times. And on Good Authority that the king will be here tomorrow. You can sample some great to see products at our booth tomorrow. Every day in tennessee we make m ms. Illion minimu we also have some googoo clust ers. Makee is another product we that starts with jack. You and in gauging meeting. We realize the summer is a busy. Ime with promises will be informative and entertaining and one that you will not want to miss. Will beomise it informative and entertaining and one that you will not want to miss. I hope you got that you did say that elvis may be in the ring tomorrow. That will be exciting. You do not want to miss tomorrows session. We are concluding our open session. Governors, if youll please join us in the governors only session which will start at 12 45 p. M. You have a quick break and well see out of her governors in that session. Thank you very much. Of our governors in that session. Thank you very much. We will see all of our governors in that session. Thank you very much. We will have more live coverage at 3 00 eastern time today. States will be talking about their preparedness and response to natural disasters. We will have live coverage tomorrow starting with the Iowa Governor on washington journal. You will be taking your calls, emails and tweets starting at 7 30 a. M. Eastern. 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The complaints we have seen in the africanamerican not thinkas they do that president obama has put in enough focus on the Africanamerican Community during the time in office. Are in the second term, do you still think the atte house is looking america too widely and not focusing on the africanamerican unemployment issues that you and your organization specifically are interested in . They are looking much more strategically. I think the president realizes that the Africanamerican Community has been a bedrock of support. An absolute that rocked. I look at my own church. I think he is looking at a more strategically at how he can make an impact on the africanamerican communities both with employment, health care and all the kind of issues that we are facing every day. You saying the white house has not been doing this before . They have been. From ave been doing it much larger lens. Now that they are now or in the narrowing it focusing on strategic things, i think they feel that they can really make a difference. They see the met checks of it. They can go down certain areas. You watch the entire newsmakers tomorrow 10 00 a. M. And at 6 00 p. M. Eastern here on cspan. The all new cspan. Org website is now mobile friendly. That means you can access our comprehensive coverage of politics, nonfiction books, american history, where you want, when you want, and how you want. It scales to fit any of your screens from the monitor of your desktop and peter to your laptop tablet or smart phone. Cspan livewatch coverage of washington. Check our Program Schedules or search our extensive Video Library whenever and wherever you want. The new cspan. Org makes it easy for you to keep an eye on what is happening in washington. Last week, the Farm Foundation hosted a discussion about whod saved the in implementing the 2010 food safety modernization act signed into law by president obama. It aims to prevent food or illnesses and recommended guidelines for improving domestic and foreign food. This is about two hours. Good morning. To our participants. While our audio cast audience cannot see the speakers this morning, they will see the powerpoint presentations and have an opportunity to participates by asking questions. The questions can be submitted at any time. This is made possible through a grant from the farm credit system. We ask that you come to the microphone, identify yourself, present your question, and proceed from there. Our topic this morning is implementing the food safety modernization act. Since the legislation was signed into law in 2010, the Food Drug Administration has been addressing the process of issuing final rules. Rules have been proposed in seven areas with comments closed. One maybe we reissue. Fda continues to work to the thousands of comments received. In fact, fda declined our invitation to participate in this forum, citing their heavy workload. The food safety modernization act shifts the focus of federal regulators to prevention of foodborne illnesses rather than simply responding to contamination. New regulations are proposed at the farm level. For some, Food Processing facilities and for food importers. We have a distinguished panel with us this morning, of those being affected by this new rule, or this new law come to discuss the impacts of this legislation. Opening our session this morning is christopher waldrop, director of the Food Policy Institute at the Consumer Federation of america. His bio is in your hand out and available on the audio cast. Chris is going to provide some background on the act as well as consumer perspectives. Chris . Thanks, charlie, thanks for the farmed foundation for the invitation. Again my name is Chris Waldrop codirector of food policy. Cfa is a nonprofit consumer advocacy or decision founded in 1968 to advance the consumer interest of research, education and advocacy and we are made up of about 300 member Organizations National as a small state and local organizations all across the country. Since fd is not here today i will do a little background on fsma and talk about the context of how fsma came into being because i think thats important as were thinking about implementation. Cpcs at 49 americans are second every year from foodborne illness, 3000 won a 20,000 are hospitalized. The Economic Costs society of foodborne els elves have been estimated to be 77 billion per year in terms of lost wages, medical costs, time off of work and that sort of thing. In the years leading up to fsma consumer saw just a sort of steady stream of large nationwide foodborne illness outbreaks linked to common everyday foods that most consumers have in the house and consume on a regular basis, things like spinach, Peanut Butter, eggs, peppers, a number of other foods where consumers were seeing these outbreaks repeatedly and over and over again. In addition consumers were expressing concern about the safety of imported foods and the inability of fda to police the imports coming into this country. Fda can only expect about one to 2 of all imports into the u. S. In addition we were seeing Economic Cost of the Food Industry as well. So the 2006 e. Coli outbreak that was linked to spinach cost the leafy green entry 350 million, and kelloggs was broke and the pca Peanut Butter recall that was nationwide and caused kelloggs itself 75 million as a result of that recall. So there were some real Economic Costs to producers and processors of cracks in a food Safety System and a lead to declines Consumer Confidence both in terms of government as well as industry. And incidentally just last month a harris poll came out looking at consumer concerns and issues around food safety, and they found 73 of Consumers Want more oversight of the federal government around food safety issue. So clearly consumers expect the government to play a role in food safety and fsma was sort of the result of that and that 20062010 area. There were strong support for fsma by both consumer groups and the Food Industry. There were strong bipartisan support for the bill. Congress passed the bill with bipartisan support in 2010 and president obama then signed in early 2011. Now, the sort of key elements of fsma as charlie said, it fundamentally shifts fda approach from reaction to prevention because a huge shift and most of the components in fsma were guided and focused around that. Theres a new inspection mandate for fda that increases inspection frequency for both domestic and imported facilities. A requirement that food plants develop and implement preventive process controls to reduce contamination in food plants, requirement for the First Time Ever that standards for safe production of fresh fruits and vegetables on the farm. Required fda to develop systems to address important safety and a Better Safety of imported food and theres such a different element, the voluntary qualified Importer Program and Third Party Certification all kind of Work Together as well as working with foreign governments to develop, better ensure the import of food to push back towards the country that are exporting to the u. S. It requires enhanced traceability high risk Food Products come enhanced surveillance of foodborne illness outbreaks and better cooperation between fda and other Government Agencies including state and local agencies, provides fda with a 30 to set standards to reduce pathogen and then provides a day with mandatory recall authority. Those are sort of the fundamental and key elements of fsma. In addition to was that test the tester amendment which provided exemptions for certain Small Businesses that market the majority of their food to it directly to consumers or to certain restaurant and Retail Companies within a particular radius and that exempted these forms are these facilities from safety regulations. It provides, requires facilities to adopt modified preventive controls or to demonstrate document compliance with state and local, and for the farmed it requires the farms to label or have some sort of signage, Contact Information for the farm when they are selling the products. Now as charlie mentioned, all seven of the major proposals have been released. You can see them here. The first four, the Public Comment period has close although fda is going to reopen the Public Comment period for certain key provisions of the preventive controls and approaches the safety rules that were particularly controversial or fda want to sort of take a second attempt at them. And get additional comments and kind of see what they can do. The last three are still open to build the additional provisions like traceability, performance standards that will come later. Fda also has to define sort of how theyre going to fight high risk food for certain at this provision. They released the methodology on that and will begin develop in the list at some point in the future. The other thing to know about implementation is fda is now under a court order to publish all the final rules by june 2015, so the clock is ticking on this and fda is needing to work very hard to make sure theyre reading all the comments, incorporating all the changes, repurposing the key provisions and finalizing these rules by 2015. So just in my remaining few minutes i want to highlight a few consumer concerns, consumer issues would like to see in terms of changes to these rules. Consumers, groups of jelly want to make sure that fda is something fsma in a timely way and consistent with the law and make sure that adequate protections for consumers but we generally have supported the rules that have come out so far weve commented on by the are some key areas we would like to see change. In terms of preventive control, fda did not record the companys to implement either environmental or finished product testing other products. That was not a requirement in the rule, neither did it get require food manufacturers to develop and maintain a supply of Verification Program. Both of these things are best practices in Food Industry today. They are, practices and we think fda needs to restore those elements into a final rule so that it is a requirement for testing and a requirement for supplier for vacation program. On the produce side, cfa supported fdas approach to regulate risky practices as opposed to risky products. So the practices that are going into the product in terms of worker hygiene, soil and menace, water, that sort of thing, but fda did carve out an exemption for certain products that they defined is rarely consumed raw. And we dont think that that is an appropriate exception. We think a lot of the products on the list actual our consumed raw by consumers, and that the crosscontamination issue that can occur in the kitchen if some of those products, with pathogen. We would like to see that exemption closed. We do support some sort of numerical standard for Water Testing to be able to have some determination that the water thats being used has met Safety Standards to fda is going to we propose that so were looking for commenting and see what that is proposal is similar for two that. We do think fda should require some sort of Environmental Testing in packing shed. This was particularly highlighted in the wisteria outbreak in 2011th link to cantaloupes weather was with us to contamination in that packing shed. Had he been testing for that they may been able to find and avoid an outbreak of those deaths and illnesses. Fda get require importers to develop and verify that their suppliers are producing food safety. The agency gave importers to options. One is an annual onsite audit of their suppliers any other sort of a range of options, a menu of options. We believe in annual onsite audit is essential so that the importer has some assurance on an annual basis that their supplier is producing safe food, providing them with safe food and not just doing a paperwork check so that they are on seconds he was going on and maintain a relationship with their suppliers. And finally Third Party Certification program, this is a new area for fda, sort of uncharted territory for the agency although they tried to align what to do with some of things that are of enough that are out there now. Third Party Certification programs has been hurt by things like jensen forms npca and Wright County as where Third Party Auditors went into these farms are these facilities, gave them very high marks and then weeks or months later there was a huge nationwide outbreak that sickened hundreds of consumers. So conference in the systems isnt high. So for fda to build to incorporate those they need to ensure that the adequate transparency which includes things like providing the public with robust information about the entities involved, selfassessment reports, audit reports, unannounced audits and be an important part of that element as well and then adequate oversight of program, making sure fda has a good sense of whats going on with the different entities that are performing these certifications so they can oversee that program and not just set it up, let it run and never Pay Attention to it again. Those are just a few o of the areas where cfa has raised concerns and wants to see some changes. Im sure well get into more detail in the commentary to look forward to that, and thank you very much for the time it. Thank you, chris. [applause] next we welcome to the podium richard gilmore, ceo of gci trade in incorporated and founder of the Global Food Safety Forum which develop Publicprivate Partnership risk minimization. Food Safety Strategies in asian markets in a global food chain. Rick is going discuss the legislation issues related to food importers. Good morning, everyone. So, fsma is really, we regard fsma in the International Perspective as a catalyst for change, both in the u. S. Context but also globally. And our focus in Global Food Safety Forum has been the asian markets with prime attention in china where we have an office and are active and so probably what i have to say is certainly to a large extent influenced by the work were doing in global food forum. The current problems that exist in the Global Supply chain, which this and is designed at least, its objective, to address, art, for example, regulatory gaps for the mitigation of risk, protection, protecting Consumer Health and racing Consumer Confidence as noted in the previous speaker. We have as another problem, inability to handle emergency contamination issues consistently and reliably. Theres an absence of uniform treatment domestic and international product. I will be coming back to that and im sure that will be perhaps a source of interest for you since theres been a lot of discussion around that set of issues. Frequently, there are less reliable technologies from foreign suppliers for tracing and certification from the point of origin in foreign supplier markets, or if you take just in an anecdotal way, when product is transported by truck and documentation is required for refrigeration, if youve ever been to some of these, some of these locations where we source product, the ability to do that and conform to that documentation can be very difficult, and fsma nonetheless rightly requires. Concerns regarding independent verifiable certification on site. This is the third party audits. If it was difficult in a domestic context, its even more difficult in the international context. The acceptance of that Third Party Certification and the problems that surround that. There is potential for fraud and gaming the system, and im sure youve all read some of the most flagrant abuses in that regard. And the absence of harmonized standards with International Acceptance of those harmonized standards is a need for private, public platforms. Theres hosts for information sharing and collaboration. I want to stress that. Thats our niche, but thats i think welcomed in the fsma strategy. The lack of equivalency in regularly systems worldwide. These disparities notwithstanding this month and the u. S. A. , et cetera, are considerable. Here are the International Provisions that i would highlight, the sanitary within fsma, that certainly foreign suppliers are focusing on and gearing up to try to address. Our moderator introduced me in saying that i would be addressing it from the importer site. I do want to note that fsma is also, helps to identify the u. S. Brand for food safety and food quality as an exporter. So sanitary transportation, focused mitigation strategies to protect food against intentional alteration, accreditation of Third Party Auditors, foreign supplier Verification Programs, preventive controls for food and animals, and the private sector and preventive controls for human food. Heres a bit of a status report of implementation, previous speaker certainly covered the first issue, namely the deadline of june 2015. And thats going with one respect to accommodate all the concerns of growth and industry is an important timeframe, but at the same time having passed the fsma and introduced some of those regulations and announced them in draft form create a level of uncertainty for producers and manufacturers, not only in the United States but globally. Fdas budgetary constraints which fda in testimony just last week on the hill didnt hesitate to say how they need 400600 million more to get their inspections up to target and so that remains an important issue. Continuing and potentially growing discord in the roar manufacturing a National Supplier communities. There isnt a manifestly clear single voice when it comes to the endorsement of fsma, the application, and its acceptance locally. Whats the international footprint, we call it, for, that is impacted by fsma . This is just a little summary display that tries to show the relationships that all or involve inherently in the implementation of fsma. So in the center, because this is not, i mean, most importantly of course its Human Element and Consumer Confidence, that at the same time this is an industry and is a very important one to our economy. So the commercial stakes are huge. And thats why theyre in the center in this little organizational chart. Trade and National Security interest, we dont always touch on those, but they are there. Passage in viruses and fraud are disrupted to international trade. Security concerns are very much there related to undetected viruses. Theres the potential for international misunderstanding and weakening the fabric of International Organizations and standards around codex and, of course, iso 9000. I forgot we got a very fancier. So my apologies. Partially because im colorblind because i cant see red. The role of the private public platforms thats a Global Food Safety Forum. It is come one, maybe for some foremost is information exchange, too, its joint Venture Investment in new food Safety Technologies from the operating system, tracing, certification, all of that is addressed within forums such as ours. And collaboration, businesstobusiness and with government regulators to ensure uniform compliance with International Standards and reduced incentives for fraud. The achievements of Global Food Safety Forum, we did receive a usda grant and we received Chinese Government in kind support. Weve had several conferences worldwide. We did corporate site visits. We have partners like the center food safety, defense what you probably know of in minnesota, its a consortium of 40 universities. We work closely with food and drug law institute. So these partnerships would like to integrate into these handson activities that we do. Chinese delegations visit to the United States, this year we intend to launch online courses on food safety for Chinese Companies and government regulators. And most certainly in that context there will be fsma compliance courses as well. And launching food safety comment and our big project which may not be completed this year but we been working on for about six months is launching a food safety Liability Insurance product for recall contamination in china trade, which does not currently, and surprisingly, exists even to the satisfaction of international buyers, as well as suppliers. Heres what we think we can do for u. S. Products. Again, very much in the context and in synchronization with the implementation of fsma. We did as noted received a usda grant and that is to promote the brand of u. S. Food safety and quality in our exports. Collaboration as noted with businesses, harmonization of standards, the ability for self revelation, something that is again presumed within fsma, because fsma and fda has to work closely with industry for successful implementation and compliance. A forum for dialogue and policy formulation, both industry and government, and a platform for regulatory agencies to broaden and widen their outreach and achieve greater and more uniform compliance. I look forward to questions. Thank you very much. Lets hold our applause. We did chris, he gives a little extra for today but since we have to allow the listening audience to participate it doesnt seem fair so we will appoint everybody when we finished today. Thanks, rick. Next well hear from dennis nuxoll, representing farm families growing Fresh Produce in arizona and california. The members of western gross provide half of the nations fruits and vegetables. Including onethird of the fresh organic produce. Dennis. Thank you very much, charlie. Good morning, everybody. Good morning to you out on the internet. Again my name is dennis nuxoll, im the Vice President for federal affairs for western growers, as charlie mentioned, our growers, we are a trade association of growers who grow fruits, vegetables, tree nuts. We were founded roughly 90 years ago. In california and arizona. Most of our members are headquartered there but we grow in roughly 30 states and some 20 odd foreign countries. As charlie mentioned when you aggregate all of our volume together, our growers collectively represent 50 , roughly 50 of the fruits and vegetables in the United States, and roughly 99 of the tree nuts grown in the United States and about a third of all the organic production in the United States. And i should say we are all sizes, were small, medium and large operations of all sizes. Ive been asked to talk about the control rules on the product safety rules, pursuant to fsma, and im going to limit myself because of time to the produce rule, what i look for to talking of preventive control rules as well. I wanted to start about talking some passionate about some overarching thoughts and this is going to sound like a lot of criticism, and i think all of us have talked about ways that the fda can improve the rule. So let me start by saying we think the fda did a really good job in executing the food safety modernization act. I think chris mentioned that they were required to issue seven very detailed, very specific rules over what are really very different topics. We think that they did a very good job doing that. Think about the produce rule. In the produce rule, fda has to start thinking about, for example, agricultural water, how agricultural water can be a pathogen, a vector of pathogen and contamination for literally every single crop grown in the United States, across every growing region in the United States. Its a significant challenge, one that we think that they did a very good job in tackling. I will, however, say were very appreciative that this year we are going to have an opportunity and fda is looking again at at least a couple of the critical element of the produce rule, a couple of the critical elements around water, soil, a couple items similarly with the preventive control. So we are very appreciative of that opportunity and its in that spirit that i want to talk about some of our thoughts about specific suggestions. To start off with, western growers believes that every operation regardless of scale should have some type of food safety plant. There is a very complete body of literature that talk about food safety outbreaks at all scales, whatever the scale of operation. And to we think that every operation showed and could have a food safety plant. In fact, we know that this is possible because over the last three or four years usda has had outreach programs to engage producers of all scale on food safety. So you know that is for is one of the fundamental premises when we talk about food safety. We think that a food safety plant is appropriate for every farming operation regardless of scale and size. Secondly, we think about the food safety modernization act and the resulting rule, one of the objectives we believe that is important to consider is that the rule should reduce the need for multiple redundant audits. And, frankly, its one of the things that isnt talked a lot about, but for growers who have a standard set by albertsons and the standard set by safely in the standards set by whole foods and a standard set by walmart come you might have a grower green 100 acres for giveaways because those standards for food safety are not uniform. As i think chris mentioned certainly consumers are very focused on food safety. That is reflected not only in the legislation that was passed by the clearly in food safety efforts that individual retailers are now pursuing and creating their own standards or looking for standards that they can adopt in food safety. So thats one of the things that we believed needs to be perhaps thought about a little bit more is how can we have this federal standard eliminate and reduce multiple redundant audits and multiple and redundant systems. Thats over growers are already safe. Lets not add another audit and another system on top of some of the commercial standards that are already in place. Finally, all operation should be covered by only one rule rather than fragmented rules that preventive control and produce rule currently have. Ill talk about that in the next slide. In the produce rule, a couple of, a couple of thoughts. Again, and i just talked about this but we believe every operation should have a written food safety plan. We think that the way fda implemented the tester amendment, i think chris mentioned the tester amendment, an amendment that attempted to exempt certain small growers. We think that the fda as they wrote the produce rule has actually exempted a larger universe of growers then the tester amendment originally envisioned. And again since we believe that every farm operation, regardless of scale, can create, and should have a food safety plant of some type, we think that thats over encompassing definition from fda should be amended. Speaking of definition, we think that definition should be clear, or size, and standalone. I suppose i could talk about five or six or seven dozen, you know, very technical definitions here. Im not sure, charlie, the audience would appreciate the. Suffice it to say, we think that definition should be clear and concise and standalone. Ownership of the product should not determine the rule to which the product is subject. What does that mean . Well, in the preventive control and the produce rule, one of the elements that fda looks at any coming which rule do you fall under, is who owns the product. So we have lots of growers, this is a fairly common circumstance, i met 100 acres of lets say cabbage and 50 of those acres when i go out and harvest, i harvest for my own label, my own brand, and that enters the system of commerce under my name, or my logo and brand. But the other 50 acres i may be contracting with some other entity. So maybe im contracting with one of the grocery chains that i just talked about, albertsons or walmart or whole foods and maybe its their brand, their logo on the cabbage your way the fda has these rules interacting, i may now be subject to two different rules, even though its the same operation, the same process, the same product. We think that there needs to be some rationalization of their, and specifically what were interested in, in that regard is looking at the risk of the product and the risk of the activity, and what is the activity, rather than worrying about what the Ownership Structure is for that particular, in this case, harvest, and that really should dictate how the rules, what compound operation is subject to a rule. Finally, apply the rules uniform a to both domestic and foreign operations. Rick, we just heard rick talk about that so i will leave that aside. Some of the general requiremen requirements, here i think one of the medical things that we would like to see revised if possible in the rule is, in both subpar to be in the will talk about this later, subpart p, and that is creating greater flexibility to create alternatives and variances, conception they are very similar. The idea is if fda sets out standards and rules to accomplish a certain level of Food Safety Health protection, there should be some mechanism to create alternatives for the. There may be other ways to accomplish the same objective. Flexibility, right . Conceptually, fda tested it on a. They have actually created not one but two mechanisms to create alternatives. Theres a mechanism subpart d. , subpart p, and so we applaud that but one of things that we would like them to refine and improve is with respect to the alternative mechanism in subpart p regattas limi limited on wated soil components of the rule. There are several components to the produce rule. We think that if youre able to demonstrate an alternative that a conscious the Public Health objective, you ought to be able to demonstrate that with respect to all components of the rule, not just water and soil. Secondly, the rule talks about establishing the same level, quote the same level of public protection. That seems quite reasonable, but when you actually read the rule there isnt a clear criteria and method and process by which you can accomplish that and show that. And in that regard, you know, we would consider, and weve suggested the fda that having an extra review process in order to approve alternates, allow those was approved to be widely available to other growers, makes a lot of sense. And then we also talked, the rule talks about meet the same microbiological standards. And again, i think when we talk about trading alternatives, conceptually the idea of creating flexibility is useful, and certainly as a member of congress, charlie, i know when you wrote rules and the laws you always thought about alternatives and things being flexible so we applaud that. But we need to make sure that fda creates a real method and process and system that produces an action create alternatives, published in and have been working on the ground. And so that sort of the idea on that concept. Subpart c. Talk about personal and qualifications and training. For us, the critical component here is that the way the rule currently is written, and this gets very technical but for those of us in washington and the beltway, the rule talks about the need to training and education and experience in order to be certified as an individual. When you make all three of those things requirements, im not sure how a new employee would ever be certified, and ever be allowed to participate in this system. And the one of the things weve argued, this is i guess its a minor fix, but the idea is that you should have the ability for individuals to demonstrate qualification separately, trading or education or expand rather than the and clauses. And thats a very technical but for those of you, especially for those of you out in the countryside, it seems technical. For anyone in the room you understand the sort of regulatory speak and how that could be a problem. Subpart d. , agricultural water. This is a part of the rule e. Has been very controversial. Chris, you mentioned it in your introduction. I would say from western growers perspective, we do not support road testing the road testing programs. Instead of what we think about is that the rule has to recognize that one size does not fit all, and water use in different agricultural, for different crops and different settings has different risks. And so that is part of the rule that we would like to see altered. And let me to you an example. Testing, testing frequency, the testing criteria for lettuce, lets say, which is a crop that is intensely watered, water touches about crop all the time. The testing regime for lettuce ought to be significantly different than a testing regime for an orchard crop where water is used clear to, you irrigate the crop, you are irrigating the tree come you are occasionally sprang into the tree for temperature control. But the testing regime and the amount of water that touches the crop, the edible portion of the plant in an orchard context versus a lettuce context are radically different. And so from our perspective, we think that programs the layout every single crop test, every seven days as i think the rule states, a certain testing regime and having apply to physical crop in their single growing region without variants, that doesnt seem logical to him. And what we want fda to focus on is the proper focus on the focus that chris talked about early on and the intent of this which is to focus on the wrist, right . How do we minimize risk . We sorely are not going to eliminate risk in the system figures was going to be some risk by the idea of this is to make food safer. We acknowledged that, and the idea really than is how do you have Water Testing calibrator of programming for the risk associated with that crop, that cropping system, that region, that doing space . So thats on agricultural water, conceptually where we would like fda to go. On soil amendments, and you know, there is a large body of literature that talks about raw manure being a significant and animal feces being a significant factor of pathogen contamination. From our perspective we want to discourage all, i repeat, all overall and untreated manure on crops. We are also similarly as a consequence concerned about some of the yard trimming standards that are in the rule. But from our perspective, you know, there is a significant, i think theres a significant debate around how to treat many were, how to heat treat it, how to compost it up properly to remove the risk factors of pathogen contamination that manure can have. Thats a significant body of size. There is a lot of literature on the subject. I think that he is doing the right thing by reexamining that space, but fundamentally, making sure that were all raw untreated manure is not in contact with product is absolutely appropriate, absolutely correct, and looking at the side sites to make sure t the science is right on soil amendments and making sure that we have the right standards set for composting, for example, for organic product. I think thats another place were fda has gone back, is in the process of reevaluating. Is another example of fda really handling this appropriate, which is going back, taking sure the site is right and what is a critical area. One of the things on soil amendment. Imbecile a minute rule there is requirement to test for, i think its wisteria. Were not entirely sure there is a valid way currently to do that. So its a little, we are a little unclear what fda would be mandating testing for substance where no test yet actually exist, right . So maybe thats an aspirational goal, but that may be something fda wants to clarify. Animals, and we have talked a little bit about animals and action works nice with this concept of manure in feces. Western growers was involved in the wake of the spinach outbreak that chris mentioned roughly 10 years ago. We were involved, heavily involved in writing was called the leafy Green Marketing agreement. It is a cloud of agreement between the industry, states and federal food safety officials. And its an agreement that lays out, sets out comprehensive, very detailed food Safety Standards. And from that experience we have seen differences in how animals are treated in the food safety context. And the one thing that im will leave you with is the need, i think for fda, they need to recognize Different Levels of risk. Initially on animals, the idea was to prevent animals from ever entering a field. There were scientists that would come out to her feels 10 years ago and they would would be aghast that birds were flying above the field. God forbid that a bird actually and in your field and there might be feces on your field. Its not a sterile environment, right . And i think over time people have got that, but certainly the initial expense was to try to great a sterile environment, tried to exclude animals, remove all the while of habitat around the field, terribly destructive, frankly. But now over time in leafy greens weve learned and i think the state and federal authorities have been involved in this process have all learned, really have to determine the risk. So, for example, if there are deer prints in your field and it looks like do you have eaten your cabbage, lets stick with the cabbage analogy, maybe, and the rule now states lets cordoned off that section of your field, you just that section of the field, as a rather than setting 30foot fences around every field in america with netting to prevent birds, lets have a Safety Program in place that identifies animal intrusion. When you identify you cordoned that ofcom you cordoned that section off rather than what was the old practice which was i had to exclude everything, if a single to cut in fuel, you just the entire field to not just the section that the animals in but you just the entire field. So i think we are hopeful that fda recognizes that. Thank you. Next wrong one. Thank you, dennis. Our wrapup presented this morning is paul muller of fully belly farms, a Certified Organic farm near sacramento, california. Poll . Thank you, charlie. Thank you to the Farm Foundation for having me here. Certainly see the issues running food safety as complex. Of the food safety organ of food system that sources food from all over the world where theres issues to be dealt with there. We have complex agricultural system in this country with small farms and large farms, and each one occupying a different space in the market system. Its a complex issue where we fit into all skills and capacities of farms to go ahead and deal with the fsma rules that are being handed down and impose on agriculture. Its tending to say that one kind of regulation will fail. I think that may not work in the real world. The rule creates a assurance of action which i think you do need to bury preventative in, and looking at how we approach food safety but there are worlds apart with us walk around washington, d. C. , i came from a from yesterday of walking around, its a different world, a different reality. Its totally incredible space between understanding of what goes on in a biologicallybased agricultural system and the bagel that i had this morning, and i had a lettuce and tomato on them that was to live ethically in a complex chain of relationships that moved up from california to here. And i could consume it with relative confidence is going to be good but i think that we need to think about how we as urban consumers expect our food to be safe. We also expect it to be cheap. I think thats a conflict that is inherent in the system where we are looking at a system where cheaper food is mandated summit in the system and keeps on pressing agriculture i think integrator greater levels of concentration. Far fewer people producing our food in the fields. Theres fewer eyes per acre out there. People actually responsible for the product and out of that field. Today with less than 1 of the u. S. Population that farms. We pay 9 of our disposable income for food. Far less than any industrialized nation. I think on the whole, agriculture has been safety within a pretty good job. There are tragedies that shake all of agriculture to its roots. As far as i talk to have incredibly been affected by the virulence of some of the microbes and how those can pass through a system. And it becomes an indictment of the whole system, becomes the indictment of reform. I think thats part of the tragedy that is taking place right now. I wanted to bring to this form of a small farms perspective. Our farm is like a lot of other farms. It started about 30 years ago. I grew up on a dairy farm in san jose, california. We have a farm about 350 acres now. Our farm has been focused on growing about 70 different crops on those acres and were focused on the health of us will come on stewardship, of natural resources, fostering more life and health in this welcome growing farm pollinators in a diverse system where we are trying to create a form that is ecologically sound and impact. We are looking to create Market Access as passionate as a beginning farmer. We started with borrowing 10,000 trying to figure out we buy a tractor. That some of the skill youre looking at. We where to go in able to get into the farming business . A lot of young, Small Farmers are asking the same questions. We were interested in country at we deal with pesticides and food. Fair return for our workers. The health and vitality of a form that can be generated several communities once again thrive but the issue of food safety needs to be put into this larger context of this larger matrix of issues around agriculture and rural communities. That is not sustained or in its focus, that it will, in fact, destroyed a lot of the people that i think are producing high according fruits and vegetables in this country through excessive amounts of paperwork, regulation, oversight, et cetera. We focus on marketing locally. About 95 of our commodity or product that we produce is sold within 150 miles of farm. Were focused on relationship driven marketing. Most of our customers will notice for 30 years, we still include customers whose children have been raised on our food. In those 30 years of selling produce locally weve never had a food incident, any kind of incident that we know. We sorting dont know everything that happens in someones kitchen but we feel fairly confident the food were selling is healthy, wholesome and vibrant food. We have 30 years of direct conversation with many of the customers about the quality and safety of the products in our field. I think our sciencebased approach to food safety is that we have intimate trade stability with the customers we serve. I think we represent many of what are called these food systems, new urban edge phones, small firms run the country that are beginning to crop up. Weve never seen on our farm so many people applying for internships with us, so many Young Farmers interested in beginning in agriculture. A lot of them are not from a farm family to a lot of them are looking at this issue and wanted to find someplace where they can make a positive change and the larger issues about food, obesity, diabetes, the fact that half of our population has a Health Related right issue, or diet related issue, i should put it that way. Looking at these larger issues in trying to figure out what kind of farms to we really want. This is not intended to be a criticism a largescale agriculture. This is intended to be a focused discussion on this month and how fsma will, in fact, create burdens to entry, create burdens to compliance, create burdens to moving up for farms that are in the middle and needed to supply local and regional markets. I didnt have a slide presentation because im not that slick, and i dont, not criticizing you guys. I didnt actually realize what i want to say into last night. My wife and i love said dont give them hell. I molded over and about midnight after couldnt sleep because i was nervous about talking to all you guys. I had, i came up with an idea thaand that even though it may e too late to deflect fsmas implementation in the produce rule, hoping we can affect the produce rule in these ways. I think i want to say that fda, some of this is the wrong way. Were going the wrong way with his rule ever going to wrongly because of the impact on small and mid size from come on the risk activities. We are going in the wrong way because we know that we need the people eat more fresh fruits and vegetables, and we dont want them to be frightened of the food safety issues associated with those. We want them to be knowledgeable to whether produced and how they produced and the care that is taken in going to get we want money to circuit locally. We know that in sacramento area, for example, close to where we live, 8 billion in trade and food in that region that could be sourced locally. Or a percentage of that could be sourced locally. You can begin to create jobs and Economic Movement around agriculture that can exist in places like sacramento and cleveland and boston. Food systems thinking is becoming to become part of the discussion that we create a safer food system. I think were going the wrong way because i think farmers are being put into a box and there are being put into the box where i could use more, if i could. Being put into a box where there can be chilling to the idea of stability. They are beginning to say that, that we can control risk and create a more sterile and vibrant after in the fields that will, in fact, make food safety. We can control all the points of potential contamination in our fields in these widely dynamic biological systems. And individually that point i think you will get themselves in trouble because once you in that box you cant get out of it. Initially i think farmers were so taken aback by this is that doing everything they can to seek to comply with any point of contamination. I have farmers who talk to me, talked last week visited the coyotes are driving us crazy, theres no water. Theyre coming in and shooting up our orchards. In californias drought, in californias drought there is no green space for wildlife to go in a few. Kind of space around on the field rededicating and growing are covered crops and other things. We are involved in this dynamic system, not approach are saying that turkeys are coming in and out of and how to keep them out. To what i going to do . Are going to destroy the wildlife after i going to fans it and turkeys are to because they will go over a 10foot fence. Are you going to begin to say it made we need to rethink this little bit my point here today is to say that i think weve gone the wrong way in understanding biological systems. Id like to point out that each one of you has 100 trillion bacteria right now working in each of their bodies, 100. 10 times more than the cells you have in your body. You may have taken a shower this morning and you might have not that that a little bit but for the most part they are there in every one of us. We dont understand our fundamental relationship with the microbial world. We dont understand but we dont understand how we begin to create healthier outcomes by understanding our relationship with the microbial world. We are shooting from the hip in these standards by creating mechanisms, which again, prevention is important. As a small farm we have a gap program. Were looking a point on our farm where we may have problems that could arise in our whole chain of relationship between ourselves and the consumer. But, in fact, we dont understand, and we dont argue for, the fact that we live in a biological funk. That the food, and in your very got, the food that you consume inoculates your very got with the beneficial, hopefully beneficial microorganisms. That creates everything that you need to become your own ecosystem. Robert dunn of the universe of north carolina, a biologist calls it wildlife in our bodies. Stanford michael biologist Justin Sonnenberg talks about the kennedys of bacteria in your system. How your indian system is really a microbial interaction system. We are just beginning to understand the science, and this is where we want sciencebased rule but we are excluding the whole area of trying to understand the science of complex microbiology and how that affects the very healthy plant, also held as part of this dynamic of how you grow healthier foods, out each one of us is impacted, has a distinct relationship without food, how your dog can be of greater source of inoculation for you than most anything else, it links you and your family becomes a biological community because you are sharing microbes. Its a fantastic, elegant, complex world that were just beginning to understand. We are just beginning to look at. You take the fda rule, and i think the way farmers look at it, is that i cant monitor all of us. I cant do what is required of me to monitor my fencing every day, go and check for any potential source of contamination, this king of you wanted your walks across the because he may have a suspected fecal contamination. I think we need to begin to think about, isnt really a source of contamination. R. R. Which is jumping to conclusion. And with all due respect to consumers that are out there that had kind of tragic incidents of foodborne illnesses, i think we have to look deeper. We have to look deeper at this whole level of soil, human, plant interaction, and how we began to shoot for a healthier outcome. I wish that we would have called this food safety modernization act, food safety more Better Health outcomes act. Because its not an absolute. I think, i think that farmers gave up a lot just in calling this a modernization act, because if it seems that the way it is presented to us, we had seven years of stagnation in agriculture, and farmers havent changed over the last seven years, and thank god weve done something. Its important we do something and its critical that we begin to think about prevention. But its critical we begin to think more broadly about the ecological framework, that the prevention is placed into, and we think more broadly about how we are a part of a complex microbiology coal system, that if you deny your existence committee tried to great star really, if you claim that some consequences that are profoundly off target, a third of people going to hospitals these they would have some form where they have diarrhea, that somehow created by the environment, overuse of antibiotics. They are doing fecal transplants into gut is that the vector load that they need in order to be healthy. Is a crazy idea. Its whats happening. All right. Im going to stop there and give one notion that in looking at this in a broader sense we need to solve for pattern. Gregory basin talked about solving for pattern. These issues are much broader, much bigger and we dont want to take the wrong action. We want to ask for the science, create preventive measures and look at the greatest source of risk but not create perhaps impediments for some of those most interesting areas where there is innovation, entrepreneurship and renewal going on in urban areas. So thank you very much. Thank you, paul now its your turn. I want to thank cspan on behalf of the foundation for covering this this morning. The purpose of the floor in the foundation is to bring education to the 300 million americans that enjoy the food that is produced in the United States so we thank cspan for making this coverage and the panelists for sharing their views. Now its your turn. To those on the audio cast, please send us your questions. To those in the room, please come to the microphone and state your name and organization. I am Charlie Stenholm former member of congress now with the law. Im a member of the house and do not dissipate in filibusters. I will recognize you as soon as someone gets a question. [laughter] and announce your name come who youre with and state your question. Thank you for the presentations. I name is well fischer with the institute of technologists into the food global traceability center. I have a twopart question and richard, this might start with you. How well has this new law i will try that again. How has this new law been accepted and understood by countries outside of the u. S. . And the second part of that is what are the Educational Outreach efforts and how are they going . Well, i will base my answer on the question mainly on our experience in china, which of course is a huge market for u. S. Consumers. The fda has located a number of offices in china. They have the level of collaboration between the fda, usda and counterpart organizations in china, the ministry of health, ministry of agriculture, has a frequency in the training courses, the conferral systems has improved greatly, and thats hosted to a large extent by the drafting of the food safety law as it was last amended in 2012 in china. So the architecture i would argue for that collaboration is now better than it ever was. As far as probably implicit in your question is how deep does it go in terms of the education and what are some of the flashpoint. The biggest flashpoint from the perspective and there are counterpart agencies in china to our knowledge is the thirdparty certified auditor system. It still hasnt been resolved. As to the status of that organization namely the independent certifier and above regulatory body responsible for the trade in china wants to be responsible for those auditors and for the certification and training of those auditors. The argument is mainly a question of how trustworthy is a thirdparty independent particularly in the china context. Thereve been lots of articles im sure many of you have read about the risk that might be incurred if there is training in the thirdparty certified auditor in china and that party sets up its own Certification Organization and it sends out auditors, certified auditors who are not indeed certified, but nonetheless, the original owner is certified that dilutes the effectiveness of the program. That is the argument it presents for its position to be the sole party responsible for auditors in china. There are cultural questions as to the level of intrusiveness that compliance might require with respect to fisma there is a little different approach. Nonetheless, there is certainly acceptance and a recognition of its importance commercially and its contribution to the health example for china itself the new food and Drug Administration is styled in my opinion after the fda, so this is really catalytic in its broad reach in terms of trying to service its domestic and foreign markets. If i could add to that, once the rule is finalized, they will have a big job in trying to communicate with the final rule to all the Different Countries that import to us and communicate the different entities and doing a lot of training in that regard into the technical assistance. There also has to be a lot of training in their own staff comes about when the inspectors are going to the food plants were going overseas, they are inspecting to the new model as opposed to the old model they were going in and doing the top to bottom inspections. The whole inspection has to beat me trained so that they are giving fisma inspections in looking at it in that context as opposed to their old one. I am the director of the Equitable Food Initiative which is according to the compliance for the food safety labor and pest management. Im curious about the role of the farm labor in this discussion. Dennis mentioned that the produce full of talked about training and so forth that we would see the farm workers not only as a potential risk factor in terms of the pathogens but also as a part of the solution and im curious to hear your thoughts about the role of the leader in fisma. I can answer that. Our workers are all given food Safety Training for the design of the farm is that we tried a fiveyear deployment for the workers and that makes them invested in the success of the farm and fulltime observers and all across. They have the food Safety Training and there are talked about the cleanliness and hygiene. One of the things that is left out, theres a larger chain of relationships we have an essential valley of california one of the greatest fruit, nuts and touchable producers in the world and the poverty that is far greater than any other part of the country and it is linked to people who are a part of the farm working through the system working the fields. This is poverty i think there are a lot of people that are working that are undocumented. I wish that you would include and folding to the discussion something broader in king about immigration. How are these peoples lives when they are home . If they are living an unhealthy conditions because they are not paid fairly or they are living lives where they can actually be healthy or they are not given the tools to be healthy we are expecting them to com come out o the fields and wash their hands and i think we have a much bigger issue. Most every farm is talking to their farm workers about how to do personal hygiene, how they take care of the requirements for bathrooms and sanitation of those things are in place. But in fact the bigger question of who is picking our food and how are they living in a much larger context i think is left out entirely. I entirely agree tha that farmworkers are a critical element of any food Safety System. What i talked about in my presentation, animal intrusion in the fields, the old paradigm was much like what paul was talking about the sort of sterilization field and build fences and keep everything out, the new paradigm certainly in the Marketing Agreement and subsequent agreements and other crops is more nuanced, and you have to identify risk and to identify and intrusion, and you corner off an area tha that maye had an intrusion and that portion of the field, rather than the whole field, is what you would prevent from being harvested. Its obvious that the individuals who were doing the identification, the individuals identifieidentifying the intrusd individuals are going to be farm labor and farm workers and those workers have to be trained adequately. So clearly there is a critical element to implementing the food safety rules and having a formulary part of it. We see a huge role for the farmworkers and as an element they are the eyes and ears in the field. They know whats going on and they can provide that sort of first alert went to be able to identify problems when they exist you have to create a sort of culture on the farm to bring those problems up. So ill call the farmworkers too be able to raise those issues that they are sort of a key element. If you look at the Processing Plant all of the workers are trained into safety and understand its a critical component of the jobs and bringing that into the farmworkers to i think through the education and training is only going to enhance the efforts. I am with the Progressive Farmer and i have a question for paul. You express concern generally with the direction the fda would go and i gather that is not likely could you point out one change that could be made in one rule under the proposed rules that would relieve a significant part that you are feeling about this . There are ways that the group gets together. We as a small farms and many other farms are focused on the market direct, marketing directly to the enduser. Its the only way you can survive in a very competitive and efficient produce industry. One they need to take a good look at is the definition of the facility if we are a farm that is growing our own product and cleaning it, putting it in a box and giving it to consumers, we are a farm, not a facility. We have information on how to keep all of the processes healthier. I think i would ask the fda to step up a bit and offer guidelines, but what is happening is i think the Insurance Industry tells the supermarket they need to have the information theres a chain of relationship and in one way it works really well and in another way it walks up the Small Farmers from entering those markets. So i would ask them generally to step back and look at the low risk activities that are perhaps more focus on the test side of this and not the same basket as one facility. I am Vice President of International Relations for the International Food Information Council and foundation. I would like to ask a question initially to eric but would welcome comments from the rest of the panel, too on behalf of our organization, and the International Networks that we helped to facilitate an alliance to be the future, Educational Outreach program, and an International Center of excellence in the food risk communication. This builds on another question about education, and i know the panel has elaborated the focus on communication to protect food against contamination and that is the ultimate goal. As highlighted the major potential for international misunderstandings and we dont need to think too far many issues where Different Countries around the world see the same set of scientific facts in a totally different light. He also highlighted a significant importance of Consumer Health and Consumer Confidence. This raises the question of Public Outreach and education and a stakeholder outreach and education so i would like to ask the panel if they could elaborate on any initiatives they have or are aware of that moving to the area of Public Education so that consumers understand whats safe and what isnt and these Good Measures are being put in place. And i would also like to ask them to take it a little bit further and ask them if they see locally, regionally and internationally opportunities for coordination and Publicprivate Partnerships, which i think may be a very important element in making this whole thing extremely successf successful. Thank you, randy. Good to see you. I consider that a very friendly question. Because in the mission that we are trying to correct our attention to in the global food safety form, we do kind of conventional modalities that are quite standard and with Different Levels of conferral but the new and the most Exciting Initiative that we think is to offer these courses which we are now in the process of designing and targeting chinese corporate managers, the technicians for operating systems as food safety regulators we are meeting with the regulatory counterparts in china to get their support to bring this on our endeavor as well as those others to collaborate with other organizations. To get as diffuse as possible into china. I think its important also to realize that in china the system in the food safety regulation which had to be done in a very accelerated rate because of the abuses was and has been a topdown approach directed from the central government, and what as a westerner was brought home to me was that thats best only half the story, and i think thats kind of part of the section thats in your question and an answer to your question because reaching the level of popularizing food safety and raising the consciousness has to be the introduction of novel my the regulatory piece, but the educational piece at the provincial level. And ive often said also that with respect to fraud, the system isnt in china going to change until the costs of fraud are recognized as greater than the benefits and there is a long way to go as far as that is concerned. But we are trying to do our little effort and try to leverage that as best as we can through these new electronic means it through the broadening of our network to raise the consciousness, which is absolutely essential you are quite right. Its in the domestic model in the case of china. Thank you for that question. It is going to be relying on a lot of Publicprivate Partnerships to get education out the stakeholders so they have the Safety Alliance working on the Training Programs and also one getting information out about fisma they have a preventative control alliance that works at the industry to give guidance, documents and those sort of things out to get information to the members, consumer groups and public i think they are going to be relying on those different elements that are out there to sort of spread the word once they have the final rules Everybody Knows heres the new law of the land. You raise a question about the opportunity to create public and private partnerships. Not only is it an opportunity, it is already occurring. At least here domestically. I mentioned the Marketing Agreement. That was an attempt to near zero where you have Industry Groups working collaboratively with the states authorities, federal authorities is a variety of other efforts in california and there is a wonderful effort in florida for the tomato industry in florida has worked collaboratively with the states to create food safety regimes. Part of that regime structure is not only to help create the standards, but also to help enforce the standards and then also to help educate members on what that standard is. So i think there is a half dozen or so examples already in place of the Publicprivate Partnership. I should note from our perspective those existing Publicprivate Partnerships, those existing standards are somehow incorporated into these rules. There is specific industry guidance for tomatoes in florida the leafy greens in california, cantaloupe, etc. In some ways that will be location specific and it is more comprehensive than anything that the fda could create a sort of macro level. So we do hope at some point they will begin incorporating those systems partnerships concretely into the framework that they already have. At one piece to that. We talked to consumers all the time and they have no idea what the reality of agriculture is and what goes on in the farm and how food is actually produced. And in fact, the guidelines are seeing visitors to the farm is potential biohazard. The whole system needs to be more transparent and open and we need to be able to bring people to the farm so they understand the processes are. But its catching on. People are talking about local food because they have a relationship that is a fundamental relationship in the place anface and it is becomingt of the dialogue. It is a place to demystify the Food Production and begin to change the relationships that are healthy, not top down and are bottomup and they are based on a direct relationship. We have to grow. Two worlds. Somehow those have to inform each other how we create a healthy outcome. I would like to make an observation at this point. This is a law that was created by congress. Very few created by congress are perfect and therefore they arent obligated to the regulatory body to implement to that which congress in its wisdom decided needs to be done. To those that may have gotten your a little bit to invite to participate but that is what they should have done. But i can guarantee you that a bunch of them are listening into this discussion because it is this discussion at which they are now having to do which i would guesstimate very few ever have a clue what goes on on the farm. That was not of their predominant reason of being. And now they have been told by the congress to begin regulating in the areas in which they have an educational curve to bring themselves up to also, and they are going to try to do that. But its a complicated procedure that we are going through. And this morning i think hopefully will be an additional educational efforts answer many of the questions that have already been posed. I have a question about the import and environmental also touches on the u. S. Consumers as well and i think we have a sort of chicken and egg problem. I know that the usda that [laughter] the linchpin seems to be as far as the imports are concerned. But in order to get confidence and this is where the consumers link in to have the confidence you need to have systems in place that will allow the importers to verify the safety of the food. How do you do that short of having these equipment unseen mutual recognition regimes in place which take a long time to establish and are not based on adopting u. S. Rules but sort of rather a mixture as i said in recognition and so forth . It seems to me that theres going to have to be an intermediate step of recognizing and accrediting if not auditing bodies and Testing Companies in order to do some of that work partly because of the confidence of how do i know that companies backcountry has the right to food safety mechanisms and standards in place . I have more confidence that this International Testing company is going to be able to go to a facility and make sure the control points are in place etc. I would be interested to hear from what can be done to establish the fsvp and from the consumer perspective, u. S. Perspective, what is going to provide the confidence that india there are equivalent levels of safety in the foreign market. Of the important thing is very complicated you point out, and the fda has never done a lot in that space. They have inspectors at the board and wait to come in and expecandexpectedandexpected they are not really catching. They are all interlocking so they almost have to Work Together in the thirdParty Certification program has to sit with the Verification Program as well on the comparability side. All of that has to kind of Work Together and its a little unclear how they are going to start falling into place. That i think that the intent is to push a lot of th it out of ty requirements back into the foreign country city made sure that they are developing the systems that would assure them that their suppliers are producing food safety and the fda to work in the country to make sure that regime is up to speed and to be able to enforce some of their lives and the thirdParty Certification, which is sort of limited and what is going to focus on sort of higher risk areas where the fda deems there is a need and i know im not giving you an exact answer to your question but all these systems have to walk together to create that assurance. I think we provided a partial answer that it is that there has to be a synchronization of that in the systems and from the china perspective that the match is end of their i could pick up the point that paul has made in the u. S. Context that has relevance with respect to your question in a broad issue of the impact of regulation in china is that the only compliance to the extent its uniform and successful is in my estimation only at the Largest Company level where theres innovative operations and the documentation from the point of origin to the point of delivery is secure. So there is also to take an example in the sector in china there is a very intense and accelerated consolidation trend in china. And certainly part of that is incentivized by the need to respond to the foreign market requirements but also by the regulatory requirements designed to match and spend and satisfy fisma in this case in the european case. So, but if you the minute you start to address the question at this level, certainly the smallscale level which by the way does enter the Global Supply chain because even the integrated food and feed the companies have to go outside of their own integrated operations to source the product because they are operating at 100 capacity. So, its a huge problem. In my estimation in the china context, theres no way that its going to be solved overnight, and the infrastructure and the technologies required to achieve that level are not there. The further you get away from the source of the production the harder it is to understand and control all of the pieces of the supply chain and to think about the farmers that might be supplying the leafy greens to california or the u. S. To mexico or do they have the capacity to test the water every week if they are getting it from a source that surfaced that water. I dont think that capacity probably exists. You have multiple layers of problems that you need to develop the infrastructure for those problems to have guarantees that they are being adhered to. If you look at organic production there is a bit of a model that the program has already developed standards where you cant use it in organic production. They have the standards in place. Fisma has looked to sort of plant goes against the congress as well but there is an International Standard and a body that oversees the implementation of the organic food internationally. Theyve developed uniform standards and protocols for inspections. Is it foolproof . Im sure its not that its probably closer than at the International Body looking at the regulating of the smallest producers serving the Large International market. With cornell foods we talked about collaboration and private efforts but what are your thoughts from each of the panelists with regards to the fda collaborations in the states . We are looking to add 50 different states and rules. But is there an opportunity in your opinion for the collaboration with the state department of agriculture to the department of health in understanding the fda limited resources and particularly of limited resources being able to train people quickly enough to get an implementation to understand agriculture farming etc. Is there an opportunity here . They are going to be working with the states in terms of inspections and outreach and those sort of things, and they recognize that the workforce isnt big enough to conduct the inspections and they historically work with the sta state. So they are making sure that the state capacity and the states training and ability to conduct those types of inspections for the fda is equal to what the inspectors would do so we want to make sure the states have the resources to do those inspections but also are doing them in the same level we would expect an inspector to do when he goes into a food plant. They will rely almost entirely on the states to work with farmers and to then conduct any kind of inspections work investigations. It simply doesnt have the capacity to be on the farm. They will be able to go on the pharmaceutical them or if they are investigating something, but theyve pretty much said that they are leaving that up to the states and work with the states on that and. There is a structure in place we have the land grant colleges that have offices in almost every county in the country and those Extension Offices or give it a suicide us testified usinge farmers with information about their how to do best practice for a lot of things but i think that they could be involved in the discussion on best practices thabut we have defunded a lot of the extension, the services are a fraction of what they used to be. And if you are asking for a relationship driven in an accountability change and if you are asking for those folks to be involved and they have Something Else to fund them, i would say that is a good place because a lot of those folks understand intimately the agricultural environment that they are working in and they are the working directly with farmers. We have a very, very Good Organization with the National Association of state department of agriculture that if the fda isnt working with that entity, consider starting this afternoon. Im with the American Veterans association. And my question pg backs off of the last question of the state involvement of how are we planning on thinking fisma with county level regulations because say you are a Small Agricultural producer you might need a permit and Different Levels of safety to sell in five different counties and that can make it economically impossible for you to attend farmers markets and a lot of that work is coordinated by the agricultural Extension Offices which are severely underfunded and understaffed right now. You have any further thoughts about the county level . Policies and how the extension would be involved ex what you are seeing the county offices become much more involved in this discussion of how do they support their regional agriculture . So they are looking at all of the mechanisms to create a prosperous agriculture because that is where their purview is. They are doing certification, promotion, education, farmer and outreach as the best practices that might be doing watershed management work and a lot of the holistic thinking about how to make that integrated with what they are providing further farmers. Thats not true across the country. You have a lot of offices that need some a shot in the arm they need people who are talking about this whole notion of there being proactive and creating a much healthier local system so that they are prospering and can make better choices in food safety. So i think that they are a critical piece to this. You know, that theyve done some really interesting work in convening people around soil and i think the other place my talk was about how do we enliven soil so that it is incredibly viable to be the viable and that every piece of that chain is a healthier outcome because soil is more vigorous and this complex biology of microorganisms and a billion are working in a healthy manner. It goes back to soil and that fundamental work i think could happen in the county offices. They are the places that farmers can begin to learn how they fundamentally change from a very singular focus on the nutrients to a biological focus on making soil a cornerstone to the processes. The National Association from the state department is standing and he may ask a question its very clear that they understand their own limitations. There is no ive never had a conversation where they wish to have the 50,000 employees or doing this so they understand their own limitations. They need to and will be accessing existing systems. Certainly the state inspection systems are part of that and they wont necessarily have to be part of this process. Certainly in the last several years they have had intense conversations in the department of agriculture and how the department of agriculture can be part of this and that the education and training for the e department of difficult or has gap certification process. How was that a part of this . How were some of the Publicprivate Partnerships that i have mentioned part of the system, and so from that perspective i am quite heartened because i think that the fda over the last several years as charlie has been ginned as they have gotten educated about thise same as they have gone from book learning to practical learning, theyve gotten very good at understanding the systems and how to integrate the systems and, you know, certainly all of us on this panel are going to be part of the process to make sure that they are guided. But i have a fairly high degree of confidence that the fda will be integrating with some of the county extensions and usda systems in the state systems that are collaborative systems already in existence to try to execute what is a very completed process. Congressman, thanks for the pl plug. I will say the fda has done a lot of work so far and i would also say that they have a lot more impact before these rules will be implemented. We are in discussions with them that the implementation can happen any time soon. Because you mentioned the gap i feel i just want to make one other statement. We are finding the requirements of the certification on the gap versus what is going to be required for fisma are yards apart. We are worried about the message it actually gets to the farmers because we have said if you are there you are partway there. I think anybody that knows and understands a is much further along, but the purpose of something to look at quality versus food safety are magnitudes apart and we have a long way to go in making that happen. Education, the amount of education, for the most part, the farm activities have never been regulated before. So now we are moving into doing that to make sure people understand where we are going into the value of having the farm assessments done we actually look at what is going on to be an extremely helpful thing to make sure that we get to that point. And some of the things almost all of the things we have been talking about i keep finding myself going back to the work funding. The fda has funding to get where they are now or at least through some parts of the implementation plan. There is not funding or a stream recognized how they are going to get from where they are today to something beyond this including working with the states and the question about the countys. They are pretty clear about the need for the collaboration of the federal state and local food Safety System. So theres a lot more effort that needs to happen at the county level. I dont think it is any secret that the budget will come out and about a month is going to propose the fees as a way of funding a good deal of the programs. They do that traditionally it is the way that the model they have is based on what they do so now we are expanding in the area of the food safety. I would like to hear how people view the right way. I dont think there is a right way that the right way to fund the activity to get from where we are today. We have long said that they need additional funding not only to do the basic job is to implement fisma as well as of the other responsibilities. Its been a longterm problem to get the resources they need to do the job to protect the Public Health and to ensure that it has those resources. In the past several years the congress has providing the fda additional funding and thereve been small increases but its also been doing very tough budget times, so its been hopeful and so the congress i think is recognized the importance and the need to continue funding and has recognized fisma. That needs to continue and we would like to see it grow. We would much rather see that the appropriate funding than to start turning to the user fees on the food side. However, we have been willing to think about that user fee if that is a way to bring in some sort of resources for the fda and get at the resources that it needs. So we would rather see the appropriations and we are looking to have a conversation about the feed to see if that in get some sort of information. We dont think it needs to be defined in the same way and it shouldnt be designed in the same way on the drug and device side it should be more of a regulation food facility fee. But its i would say the next five years we need to do a lot of hard thinking and try to figure out how we can get them the resources that we need. I teach a state at the university on monday nights we had a good discussion of this issue in this last monday and i want to give some opinions. As i tell my class im going to share with you my opinion based on 26 years of experience in the congress and the before and after. And they always ask, you know, do you gave ppapa tests . Though i dont. Im going to give you opinions. How can i greet yo grade you dor opinion is different than mine when you may be right . Do with that disclaimer, i want to make some observations and i would appreciate the reaction of the panel on any or all of them. I think the name of your farm was a very good educational operation for the panel today. When you have extra costs on those that propose the food, who is going to pay for it . The people. Who can least afford the amount of paying for the additional cost . Those on the very poorest end of the scale. So when we Start Talking about regulations that satisfy someones opinion, rather than really dealing with the problem, we are not living in the right direction. I put my budget hav budget hat i wouldnt be very supportive of giving the fda any more money or any other regulatory body until they demonstrate a better job of doing what they were supposed to be doing in the first place. My question to you is anyone on the panel of where anyone that doesnt believe these decisions should be made on the sound science consensus sound science . You can drive a mack truck through sound science cant you . How much science in this country is influenced by the questions asked and how the question is framed. And the opinion of the investigator. I think that if you define the very sound science as being open and looking at all of the issues that are not starting from the point of assumptions. You know, chris, you mentioned the 126,000 hospitalizations. That is a pretty big number until you look at the over 1 billion that occur in the United States to get to 126,000 hospitalizations. Are you aware of do we have a trendline is food safety going up . I mean hospitalization, foodborne illnesses going up in the United States and at what rate . We do not have the data to be able to look at the trends over time. They have been able to do estimates. So they have done a new estimate and that is where they do that, that they havent been able to say year by year, the hospitalization or death number of hospitalization. Said about to be a little bit comforting to all of the policymakers. If we really dont have that information, then how much credibility should we put in someones opinion. The hospitalizations out of a building in him is it possible that we would ever get to zero . I want to answer my own question. I am aware of people that have had and are having a tremendous amount of influence on the food safety questions that are not using the sound science. Of those that oppose the biotechnology of those that oppose genetically modifying plants. They have opinions that they are welcome to. They may be right. But until there is some Scientific Evidence that they are right,y