importance of the basing inspection and product testing in any other interventions by the agency on sound science. the bill does have a poor and directives to improve testing in the science base of the agency's activities and is critical from top to bottom activities are more efficient and effective and not just more frequent. this bill's requirement that the agency's activities are risk-based is particularly critical. ..

>> in every discussion i has been in pertaining to food safety the importance of the inadequacy of effective information sharing is probably the most vocal topic. to see the issue addressed in the bill to prove the technological information is important to accomplish this but perhaps more important sharing policies far beyond any logical limit the failure to do so threatens the public health. these mandates fda will have two increase interaction incorporation of the state and local agencies which require funding and focused attention.

federal regulatory agencies frequently are prohibited from sharing proprietary permission obtained during investigations. both directions between fda and cbc as well as the public part partners is critical of include such things as distribution during recall, information unsuspected products or producers an informational potentially exposed people. the fda, cdc must have the authority and expectation to share actionable information with public health partners to the extent necessary to protect the public's health program will conclude with a final comment about the importance of ensuring the fda with the state and local partners to have adequate resources to meet their responsibilities for which they are charged in this bill. no one would argue the fda is currently underfunded, overworked and overwhelmed state and local food capacity must me robust

in order to maintain an effective food safety system. consistent funding must be dedicated explicitly to sustain the food safety program at fda as well as the state and local partners to work with them to keep the food supply safe. americans will each 1 billion biel's today i cannot think of a better investment than one that would keep every single one of those meals safe. >> good afternoon mr. chairman pallone and members of the subcommittee i am pleased to do to the fresh produce industry has been a leading proponent of strong federal oversight of food safety. my name is tom stenzel i am ceo of united fresh produce association we have been privileged to testify 10 times in the last two years before this committee or other members of congress perhaps only runner up to caroline on this panel. [laughter]

our board of directors jittery 2007 adopted a series of principles calling for mandatory science based regulation by the federal government and we congratulate you of the full committee to present the draft of the food safety enhancement act of 2009 for consideration. my written statement contains a number of suggestions for strengthening the bill i will focus on three key areas of concern. let me start by repeating the policy principles to protect public health and to ensure consumer confidence produce safety standards must allow for a commodity specific approach based on the best available science of us consistent and applicable to the identified commodity no matter grown in the united states are imported and have federal oversight with compliance in order to be credible to consumers rear please these principles are recognized in the draft of the food safety enhancement act of 2009 looking specifically at the draft we strongly support

the bill's intent section 104 and 58 focus on maximizing public health by implementing regulatory standards for those specific raw agricultural commodities it believes are most critical. the at have estimated only five commodities associate with 80 percent all produce related outbreaks the past 10 years that is where we must direct our resources in a highly diverse industry described as hundreds of different commodities one size does not fettle. we support congress specifying it has broad authority it determines necessary but with a clear mandate to develop will making up focuses resources for maximum public health benefit of the specific types of commodities that the secretary determines such as necessary to minimize the risk of adverse health consequences. we recommend section 104 strengthen for collaboration

between hhs and usda and allstate agency's education, research, enforceme nt with regard to produce progress important we have the broadest base possible to hubbell stakeholders understand and comply with the fda said public health standards. section 107 entrees ability the fresh produce industry is committed to trees ability of our products and as i presented in detail testimony on appropriations on the subcommittee earlier this year we have underway a produce trees ability initiative to provide electronic trace ability for 6 billion cases of fresh produce the movie annually within the united states a mass of an extremely expensive long-term undertaking but a commitment we have made. however we are concerned the prescriptive nature of section 107 could derail these important efforts to bring

these costs efficient and cost-effective technology to bear on the challenge for graduate provisions we urge congress set a goal the mandate for future stability but not overly prescriptive requirements such as those in this bill. we believe congress to be more effective in mandating the intensive vibration of technology systems and pilot test that will feed to the end result we desire. to the point* this legislation should set a goal for supply chain to disability and not a single out individual food categories fortress ability. finally on the question of imports, i believe the committee should carefully examine all of the provisions regulating imported crude to ensure equal treatment and fair standards for imported and domestically produced food. it should be maintained for all provisions section 213 support the intent to require importers to register with fda

and comply with importer practices. this is the standard protocol and the limitations and restrictions envisioned in section 100 by provide very extreme authority to be used by fda only in the worst-case scenario when required to minimize the risk of severe adverse health consequences. with imports we have a safe and secure importation program in section 113 that the bill require fda to implement a program with clear direction that it shall be implemented rather than maybe. 143 and country of origin label the fresh produce agency is already required under the 2008 farm bill to provide mandatory country of origin labeling we have moved rapidly to ensure compliance and urge those products that are already covered be specifically exempted from new

coverage from the act. let me conclude with a comment about public health. the very department of health and human services the regulates air safety has a dual responsibility to promote public-health but consider the fact we need as americans to double our consumption of fruits and vegetables to meet with a dietary guidelines for the with that imperative years of food safety have no place in the fresh produce a department. pinky for your leadership. >> thank all of you we will now take questions from the panel five minutes each. i will start. there are many in the industry that have called for prevention and a stronger emphasis on prevention and many feel we should share the responsibility for making food safety a as well as manufacturers to be responsible for the foods that they make the draft proposes

to do this three new emphasis on prevention the requires companies to conduct has an analysis to identify potential safety risks for the food the handled and requires the facility owner adopt preventative measures to adopt or eliminate the risks. can you elaborate how the preventative controls put forth will help to make you safer and can you give us examples of preventive controls and how they may be implemented or applied? >> thank you chairman pallone. the systems that are going to be applied in this bill are well tested. we have watched the implementation of what are called hazard analysis conchata cool control point systems in the seafood industry, beef and poultry industry, and fresh juice and other industries. the problem with the approach

fda has been taking up until now and the solution your bill will bring is they have been trying to apply the systems one by one, industry by industry. what you see is a unitary view among industry and consumer organizations that these systems are needed across the board. there developed by the industry, driven by the industry, they design the programs but the government can use them to actually go in and conduct inspections which are much more meaningful than the ones they do today. >> gumby ask each of you then quickly if you would respond if you support these preventative approaches to food safety? >> of some of eight yes, sir. >> yes. >> yes, sir,, we do. >> great.

obviously we have a consensus on the preventative approach being critical but access to records to one of the new requirements references access to section 106 requires food manufacturers and producers retain records relating to the foods they read -- and provide them to the fda and in the event of an outbreak or inspection have access to information how foods are produced manufactured transported or stored. dr. jones can you describe how this access will be helpful to the fda with a foodborne disease outbreak? >> access to those records are critical for them to pinpoint the interventions by also think the ability for fda to share that data with other agencies that assist them in

investigations is critical part of that is a huge barrier. have worked on outbreaks where fda has the names and phone numbers of people who have consumed contaminated product, or thought they could not sure that information with public health departments for responsible for calling those people and telling them not to eat the stuff. that is mind-boggling. it is subtle but there is some addressing that issue in the bell. >> you want to comment on ms. dewaal that you believe access to records provision we'll help to protect public health? >> the access gives the agency the ability to look at plants. take a look at them as they operate over time. today when the fda inspector goes into the planned they see the four walls, they may not even get access to any records of that facility.

they can look at production practices as they happen that day. but with access to records provision with this preventative control system and written food safety plan, the inspector will be able to go and look back where the company has faced challenges in its operation and how they address them. >> thank you does anybody else want to address it? that is fine. thank you. mr. deal? >> thank you. i guess i will start with you from the producers' side of it. in a general context do see any problem or potential of this legislation and creating overlap with the fda jurisdiction and requirements to do things versus courage usda requirements to do things in our food supply? >> we don't see any

jurisdictional issues of public health. fda has the statutory authority now to regulate the fresh produce industry. we do suggest strongly there be a good coordination with the u.s. department of agriculture and education, enforcement and certainly one of the keys to implementing this bill will be an effective structure with fda working with usda and state and local agencies with compliance, enforcement inspections that needs to be strengthened but not a jurisdictional issue of competing authorities the. >> minder standing at the production level could agricultural practices are the primary preventative tool and mechanism for dealing with it at the production level. do use the perhaps updating or improvement on those agricultural practices standards as they apply to

fruits and vegetables is important and is there anything hear that will prevent that from taking place? >> yes, sir, that is an extremely important part. the fda agricultural practices are called to be updated with this draft legislation. we support that as a baseline guidance. for those specific commodities which fda has determined a significant level of risk and then you move into the rulemaking procedure but that is one of the key things the way to best focus resources on the greatest risk i said in my testimony 80% of all outbreaks have been associated with five commodities. the basic practices are very appropriate for all fruits and vegetables so let's focus rulemaking on those specific commodities. >> i believe you made the point* that since we have

mandated studies and pilot projects that those be completed before we start trying to break the rules and regulations? is that one of the points you're making? >> entrees ability. >> it seems if we do the studies and pilot projects we ought to do that before we write regulations because they would give us the information to guide us in the rulemaking progress -- process. in that regard mr. stenzel you have put interest ability standards. how do you see you're current efforts of trees ability, how do they correspond with this legislation? >> this is proving to be a massive, massive undertaking. we are committed to doing it on a voluntary basis before requirement but extremely, a complex system of creating that interoperable system that can see lifecycle all the way

through of the products. the specific language in the bill, the full pedigree of each product gives us great cause for concern also removed down a path of hundreds of millions of dollars invested in interoperability systems we don't think they may be to the terms of this bill. we was strong reifies fda the mandated to be involved in the technology, pilot test come and learn about each industry and then it right to the regulation. it is premature to tell every industry exactly how we should be done until we have the greater learning. >> one of the stairs we have alluded to is the mexican pepper scare that adversely impacted the tomato industry. we'll ask you again how to reinsure that foreign producers need that kind of standards that we would need would it require a foreign

producer verification system of some sort? >> the requirements are appropriate importers will be required to register with the fda and is part of good practices they have to ensure the products have been grown in accordance with these standards. we believe that is an appropriate step to be taken know when envisions going searching around for every farmer around the world nor every farm in america that simply will not be the case for the authority should be there for fda if they need to investigate, but the basic responsibility we'll lie with the importer or the food manufacturer. >> does your organization represent organics? >> yes we have a number of organic suppliers in our group. >> i have a statement i think

we have cleared it with your staff from the frozen food institute to be inserted into the record. >> chairman dingell? >> thank you. like to commend the panel for their very helpful testimony. i would protect the like to address my questions to ms. bailey with gm may. welcome. by to follow-up and thank you for the way in which gm may have then working with the staff to resolve the difficulties which we can find out like to express my particular thanks and the most helpful way in which you have behaved and a remarkable change that has occurred under your leadership so i think you. first of all, am i fare is stating fda has been so underfunded they cannot provide the necessary services

to protect the industry or the consumers for a number of years? >> that is right. >> as a result they have been an adequate week to ensure the safety of the nation's food supply? >> yes. you are correct. >> unfortunately our report 88 -- reported a -- reporter. >> i said yes fda has not been able to update good manufacturing practices since 1986 that is just one example of something they have not been able to do. >> that sounds like a serious matter. >> good manufacturing practices serve the basis to make those are required food and drug and cosmetics and pharmaceuticals. >> that is right. the preventive controls we are talking about is one step up from manufacturing practices you want to have them updated and there have been enormous

advances with pathogen control environmental testing and all of the advancements and fda has not been able to incorporate them into good manufacturing practices guidance for industry. >> would you agree that science base has eroded? >> that the technology systems are inadequate? >> yes. >> fda has not been doing an acceptable level of serve valence for research? >> would you agree they have not conducted satisfactory inspections over the years? this figure i got which seems interesting fda conducted 6,562 domestic food facility inspections 2008. the total number of registered facility is 378,000 of many more out there in the world is

that a fair statement? >> that is accurate. >> i am sure you agree as you have said fda needs additional resources to do their job? >> yes. >> i want to commend you very much for the way you have been working with us i want you to know we will try very hard to see to it we come up with something that enables industry to work, prosper and have a satisfactory fda that protects the consumer but also does not overburden the industry. we look forward to continuing our efforts on that and i hope you will continue to give us that assistance. again the reporter does not have a nod. >> we look forward to that i thought dr. hamburg at this morning way a good basis for those

discussions going forward. >> i am troubled about four people who deliver crude into the united states. it does not have the right number of inspectors at the border? and do they? >> no. that is right. they do not. >> the only inspect 1% of food coming into the united states. and games are played oftentimes where they are turned back where food shipments are turned back with the results they go out and come into another port. are you troubled about that? >> yes. we need strong inspections at the border. >> i am also troubled about the fact food and drug has no understanding with their sister agencies, customs, immigration

, as a result there inspectors are at the ports and no food and drug folks there we ought to see to it there is a proper agreement to make that possible so they work together instead of ignoring each other's business? is that right. >> that sounds like a good idea. >> i am three seconds over time it is a pleasure to be with us. >> thank you chairman dingell. >> mr. shimkus? >> i will try to be quick i sat in on the first testimony can anyone tell me what caused means? what does may cause been? >> and it is a very vague terms. >> i am not certain. >> the actual subsection says

if the secretary has reason to believe they use or consumption of or exposures to an article of feared may cause adverse health consequences of the actual standard is reason to believe and of the may cause is in there but it really is a standard of which is very protective of public health. >> dr. jones? >> i agree with those comments the. >> i believe it is much more vague them that. >> i hope we can work to clean up that language and i think there is an opportunity then ask the subpoena question again to those who want to talk about there are three criteria of section 311 which i did not delude to is any other proceeding respecting a violation of the act?

i think most people agree. and a hearing or investigation to determine if a person is in violation or provision of this act? i think the average person would say okay. subpoenaed of the babies. >> any other matter relative to the commissioners jurisdiction and the public health prithee anti-tampering after any other matter. vague? >> mr. ambrosio? >> it is vague. >> yes. it is paid. >> actually these acts are important to protect us against swine flu, bios terrorism, so if in fact, these acts, if you understand the relationship between the food drug cosmetic act and legal statutes i think the language maybe appropriate. >> maybe but it may not.

>> like i am a physician and not all lawyers. >> neither am i but i will pretend to be one. >> my tendency is to err on the side of protecting the public health but i agree. >> my tendency is to question the legal language of the law may harmful swept eight language of the law is very important i have found. interesting things can be done. >> it is also a general standard and i do suggest an area to look at. >> mr. stenzel section 104 which calls for the secretary to issue regulations on produce safety standard language says the standard may include nonstandard for safety. this is a lot of the language stuff that i have been focusing on today why would we want the agency to issue minimum standards instead of

the appropriate standards? lire thank you for addressing that i put that in my a testimony we should not put nonstandard three should have the agency right the standards that are most appropriate that all producers should follow. as soon as we have mentioned standards the first thing that will happen someone we'll say that is not a good enough so if we go down this path make sure that agency rights the most appropriate standards. >> industry need 70. if we have paid language there is uncertainty and with that comes higher risk because of trying to comply. i appreciate that. ms. bailey, what was surprising in the draft i cannot talk about it hearings