Committee on the Use of Public Health Data in FSIS Food Safety Programs. Meeting Recap

Transcription

1 Committee on the Use of Public Health Data in FSIS Food Safety Programs Meeting Recap September 22-23, 2011 The Keck Center of the National Academies Washington, DC Disclaimer: This meeting recap was prepared by National Research Council (NRC) staff at the request of the Food Safety and Inspection Service (FSIS) of USDA as an informal record of issues that were discussed during public sessions of the meeting of the NRC s Committee on the Use of Public Health Data in FSIS Food Safety Programs (Standing Committee), held on September 22-23, This document was prepared for information purposes only and as a supplement to the meeting agenda and presentations. This document has not been reviewed and should not be cited or quoted, as the views expressed do not necessarily reflect the views of the NRC or the Standing Committee. Committee Members Present: Craig A. Reed (Chair), Gary R. Acuff, Douglas L. Archer, Julie A. Caswell, LeAnn B. Chuboff, Louis Anthony Cox, Jr, Roy Curtiss, III, Sandra B. Eskin, Kathleen A. Glass, Lawrence Goodridge, Craig Hedberg, Lee-Ann Jaykus, Jeffrey Lejeune, Jianghong Meng, Greg M. Paoli, Steven C. Ricke, William H. Ross, Juliana M. Ruzante, William H. Sperber, Christopher A. Waldrop, and Martin Wiedmann. Committee Members Absent: Thomas A. Louis, Donald W. Schaffner, John N. Sofos, and Robert V. Tauxe. NRC Staff Present: Camilla Y. Ables, Ruthie S. Arieti, Winyoo Chowanadisai, Austin J. Lewis, Shan Ma, Janet Mulligan, Maria P. Oria, Robin A. Schoen, and Peggy Tsai. Page 1 of 18

2 Thursday, September 22, 2011 A. Update on A Study of Food Safety and Other Consequences of Publishing Establishment- Specific Data (This was an update on the progress of the study, not a report of the study findings.) Lee-Ann Jaykus (Chair of the Committee) provided an introduction of the study committee and statement of task. The committee is currently preparing a letter report to be sent out for review within the next few days. The 12-member panel has met twice (May and July 2011). Open sessions featured presentations made by FSIS, an expert in psychological effects of data release, an industry expert, and EPA. Report organization Chapter 1: Introduction, discusses transparency, and provides the charge to the committee and the approach the committee took. Chapter 2: Discusses FSIS data, what types could be considered for release, and the FSIS current data management programs. Chapter 3: Extensive literature review on establishment-specific information release and programs already in place; may have relevance to how FSIS releases data. Chapter 4: Examines specific types of data; discusses information that FSIS may want to release and what issues need to be addressed before that release is enacted; also includes anticipated consequences of that data release. Report provides a set of conclusions. The study involved a very vigorous debate among the committee members. Discussion among the meeting participants led Lee-Ann to provide additional clarifications, such as the following: That the effects on international trade agreements were considered in the study. That issues of biosecurity were also raised. That there may be a difference in what has been documented in the academic literature to happen when data are released and what may be perceived to have happened. B. The FSIS National Residue Program I. Introduction to the National Residue Program David Goldman (Assistant Administrator, Office of Public Health Science, FSIS) introduced the session and identified the issues: The FSIS is looking forward to practical and meaningful changes to the National Residue Program (NRP), which focuses primarily on veterinary drugs (their appropriate/inappropriate use) and the inadvertent exposure to these drugs. Residues is a hot topic, as evidenced by the recent release or posting of reports/documents/guidance from the OIG, FDA, the Codex Alimentarius Commission, CDC, and GAO that pertain to the use of antimicrobial drugs and antimicrobial resistance Page 2 of 18

3 (AMR) in animals. The GAO report on antibiotic resistance highlights the questions that will be discussed by the Standing Committee at this meeting. Antimicrobial resistance is a classic preharvest issue and more knowledge of live animal practices is needed. There has been a resurgence of interest in AMR. Part of the AMR issue is the use of antibiotics in the farm, specifically the inappropriate use of veterinary drugs and their negative impacts. II. An Overview of the National Residue Program Patty Bennett (Chief, Chemical Residue Risk Branch, FSIS) described some of the specific elements of the NRP (see Appendix for PowerPoint presentation). Items mentioned included: The FSIS mission, activities, and responsibilities. The agencies involved in the NRP. FSIS residue sampling plans. Compounds commonly detected by the program (i.e., what producers are mostly using; these are more or less the same in the last years). Testing procedures (how the new (KIS) test is better than the older (FAST) test). Examples of classes of animals (production classes) with the greatest numbers of violations and the top violative residues per production class, which are fairly constant, for reasons that may include their convenience or accessibility (over the counter) to producers. (FSIS would like to know more about why producers make the decisions they make, and why they use these substances). Proposed changes to the NRP (the FSIS is ready to make changes in response to the OIG criticism that they are not testing for more chemicals; FSIS is proposing to use new methods for testing to detect more chemicals). Knowledge gaps (What does the industry need in order to treat animals effectively? How does the industry decide which drugs to use? FSIS grapples with off-label use by producers; do the producers understand the rules? FSIS wants to know if the drugs being used affect the pathogens that they are seeing; would better sampling improve production? What is FSIS not thinking about? FSIS needs advice on a 10-year plan). The discussion that followed included the following topics: Comment: Is the overall goal of FSIS to reduce human exposure to chemicals or to reduce the development of microbial resistance to these chemicals? Response: FSIS understands the exposure of humans to veterinary drugs, pesticides, and other chemicals. FSIS is more cognizant of what animals are exposed to, the agency needs help to create a program that will test for those chemicals in order to make food safe. Comment: How much does FSIS know about the specific public health impacts of these chemicals (e.g., do they have data on allergic reactions in people eating FSIS-regulated products)? Response: FSIS does not have these types of data. Comment: With regard to targeted sampling, is this based on time or volume? Response: Based on volume. Plants with higher slaughter volumes get sampled more. Any plant that slaughters 2,000 animals is eligible. Animals to be checked are selected randomly at the time of sampling. Page 3 of 18

4 Comment: Is special attention given to plants that have history of high residues? Response: FSIS doesn t consider a plant s history. Where violations are found, inspectors are given instructions to retest. Plants without a testing program get more USDA inspection. Some targeted samples are taken to follow up. Primarily, violations come from an inspector doing screening because of the appearance of the animal. Comment: Do the plants know when they will be sampled because the producer might work around this known schedule. Response: They do. They are allowed to collect a sample at the same time the agency does. They know they re going to get a certain number of samples per year. When an inspector receives a request, (s)he has a window in which to collect the sample. Comment: A committee member responded that based on his experience with FSIS, the veterinarians would know when testing would occur but not everyone in the plant would know. Comment: To what extent is exposure assessment done for setting tolerances? Does human health consequence, animal health, environmental health play a role? Response: FSIS does not set the tolerances. The FDA and EPA do this. FSIS collects samples, determines if levels are above or below the set tolerance, makes dispositions based on carcass results, using the tolerances of EPA and FDA and decides which parts of the animal are safe. Then FSIS holds the plant responsible, shares information with FDA (who then decides whether to investigate the producer). Thus, FSIS regulates but does not set tolerances. Comment: One approach would be to compare sampling results against theoretical results based on good behavior or other assumptions (what would sample results look like if a plant operated perfectly?). This would set levels at which one takes action. Also would relate samples to how public health is affected. Comment: Is the number of animals sampled representative, given the large number of animals? Response: FSIS would like to have a better idea of baselines. Response: Beyond the tolerance, we cannot prove that the meat is safe for consumption. Comment: Why is FSIS shifting from FAST to KIS? Response: KIS provides results faster; hence it helps in making decisions sooner. It is also a better detector than FAST, generally. However, it is less sensitive for some residues (neomycin). Comment: It seems that FSIS is regulating the plant that is not responsible. How is residue program testing enough to make a significant difference? Response: Residues are considered under HAACP. So plants are responsible for controlling residues in their plant, even if they are not responsible for the presence of residues. III. The FDA Drug Residue Program Neal Bataller (Director, Division of Surveillance, Center for Veterinary Medicine, FDA) discussed the role that FDA plays in the NRP (see Appendix for PowerPoint presentation). Items mentioned included: What a residue is. Acute vs. chronic effects. Animal drugs with chronic effects. How risk analysis is done; determination of risk score. How FDA builds a case against a violator. Communication. Page 4 of 18

5 Databases (information obtained during inspections of firms involved in tissue residue violations). The discussion that followed included the following topics: Comment: How often are new drugs added to the list to be tested for? Response: It depends on the FDA s capacity to determine what new drugs are being used; however, drugs/chemicals used by producers haven t really changed much over the years. Response: The methods to be used by FSIS are better than what they have been using before. For the scheduled sampling, new methods will be used to test for antibiotics and non-steroidal drugs. Perhaps not finding chemicals is due to the methods used in the past. Comment: A side-by-side comparison of the old and new methods would be helpful. IV. Chemical Use in Pork Production Scott Hurd (Associate Professor, Veterinary Diagnostic and Production Animal Medicine, Iowa State University) gave a presentation on modern pork production (see Appendix for PowerPoint presentation). Items mentioned included: When there are residues in pork, it is an indication of a mistake somewhere along the system (e.g., administered incorrect dose, inability to read dosage, delivery date was moved up). How can the swine industry treat animals more effectively? Most products have been on the market for 50 years. Better individual pig care is needed, and there is a need to train people to identify sick pigs early on. Better outcome analysis is needed. New labels for products are needed because there are challenges with off-label usage. Why do producers make the choices they do on products? Based on historical usage, what growers have done in the past. Based on necropsy data to determine prevalence of pathogens. What are pigs dying from? Biggest percentage for baby pig deaths is attributed to crushing by sows (hence reason for farrowing crates), with the next being diarrhea and starvation caused by refusal to eat. Leading cause of death overall is related to respiratory problems. Challenge in drug identification. Farmers are more familiar with the drug name label rather than the active drug ingredients, therefore some respond incorrectly to questions about drug usage. Three general purpose areas for antibiotic use: growth promotion, prevention, and therapy. Growth promotion is nontherapeutic for boosting production. Prevention is to assure health prior to clinical signs, based on history. Treatment is to respond directly to overt illness, with pathogen identified. The route antibiotics are administered should not be confused for the purpose of their use. For example, antibiotics used in feed can be for growth promotion, prevention, and treatment. However, antibiotics are never used in water for growth promotion, but are used in water only for prevention and for treatment. Intentional illegal uses by growers are rare or accidental because there is a large business investment at stake. Packers such as Cargill and Hormel are concerned about such residues; therefore it is not worth the risk for these big businesses. There are still challenges for offlabel use. Guidelines are provided by AVMA for treatment protocols. If growers are using extra-label drugs, they need supervision of a veterinarian, however, veterinarians will not recommend extra-label use unless absolutely necessary. Packers require producers to be PQA certified (required for > 95% of packers). Biggest challenge is educating animal caretakers Page 5 of 18

6 on proper administration techniques and needle use. For example, there is anecdotal evidence that wrong feed is delivered to the wrong bin. When residues are detected, it s an outlier. What are the underlying problems related to chemotherapeutic uses? There s a shortage of new and effective anti-infective drugs. Big shortage of data on withdrawal times as they relate to injection site. Not allowed to alter dosage because of the veterinary feed directive. Conflict between welfare of animal (veterinarian would want to treat) vs. challenges of withdrawal times (would say that you do not treat). FSIS should get on the farm to understand the challenges. The discussion that followed included the following topics: Comment: Do producers have the liberty to administer drugs? What is the need for licensure? Response: Growers have authority to administer dosage via prescription. Comment: Are there procedures in place for identifying and resolving producer mistakes? Response: Yes. If FSIS detects residue, they can trace that back to the grower. That producer will not repeat the mistake because of the associated economic consequences. Veterinarians can also set up an intervention to help producers convince the buyer that they ve improved. Comment: Is the usage of higher doses of antibiotics more prevalent now than in the past? Response: It is unknown. Comment: What is the issue with single site injection as it relates to residues? Response: There seems to be problem of putting too much drug in any one injection site. V. U.S. Poultry Industry Residue Avoidance Stephen Roney (Veterinary Medical Officer, NPIP, VS, APHIS) gave a presentation on the integrated poultry industry (see Appendix for PowerPoint presentation). Items mentioned included: 8.5 Billion broilers are the majority of the 9 billion birds slaughtered annually; $40B industry. Trend: consumption of chicken has increased in the last 25 years % Of the industry has been totally integrated, which means the same company owns, oversees, and pays for birds from beginning to end, therefore there is no need for license to treat their own animals (but still need license to prescribe drugs). Pullets, which are grown to be breeders, lay eggs but are not slaughtered for meat, so residues are not really an issue. Treatment for pullets is via water or feed, as producers don t touch the birds. The hatchery is the only time producers touch the chickens: in the past, nearly all day-old chicks were given gentamicin injections, now it s only 50%. There s a 35-day withdrawal for gentamicin. No growth hormones are used because they are ineffective for avian species. Growout farms: farmers own the house ($250,000/house), very strict biosecurity program (no visitors on farms to prevent bioterrorism). Feed Additive Compendium lists approved antibiotics. For broiler feeds, bacitracin and virginiamycin are used. These do not cross the intestinal barrier. However, there is an argument over whether this is prevention or growth promotion. Page 6 of 18

7 Pesticide Residue Monitoring Program. Results must be back before the chickens are processed. Feed ingredients are tested for pesticides. Soil samples are taken (looking for petroleum) before farms may be set up. Bedding and litter are tested every 6 months. Residue avoidance standard operating procedures. Twice the amount of withdrawal time. No systematic antibiotics in broilers. Disinfectants label growers subject to termination. Pesticides used/labeled example of sevin (all poultry companies dropped it because the company did not seek reapproval for poultry usage). Pesticides stored separately from medication. Plant security (bioterrorism). The discussion that followed included the following topics: Comment: What about aflatoxin? Response: Every load of grain is tested, but this can be detected more quickly by the performance and growth of the birds than the assays. Birds are really sensitive to any mycotoxin. VI. General Discussion Comment: What is the approximate cost of the NRP? Response: It would be really hard to calculate this because it is a cross-agency program. Comment: How do you strategically determine which tolerance receives the highest priorities? Does the sampling program reflect public health priorities? If you re not finding drug residues in all this testing, is testing necessary to prevent people from misusing? Response: FSIS is unsure which compounds should receive highest priority. Violations drive testing. Example of penicillin: will see why there s a problem and address it with the producers. The potential exposure to the public helps determine what receives priority. The agency conducts target testing and has been looking at these chemicals for many years. FSIS welcomes advice on how to make strategic changes to the program based on various factors that help determine priorities. Comment: So moving forward you re going to have a different set of criteria? Response: The algorithm is in the Blue Book. We need to overhaul the algorithm because it currently requires information that we cannot get. We need to be able to justify what we re doing. If we find lots of negatives, is it necessary to keep testing? We test in order to have a baseline so then we can tell if we see anything that s unusual. But then, what about items not regulated (melamine, etc)? Maybe pigs are important to test because of high public consumption, or milk, because there are more residues found. Response: We re not at a point right now to prioritize tolerances. Comment: It seems to be a year by year assessment. Does the program assess trends over time? Response: FSIS wants to know if they are doing an adequate job of sampling, and hope they can do more trend analysis and even be predictive of future usage. But we re not there yet. Comment: The GAO report was critical of the NRP in areas of imports that are not being tested for. Is intelligence on what to test being provided by the Foreign Agricultural Service? Response: FSIS is working closely with FAS. FSIS is interested in certain chemicals, but that list can certainly be expanded. FSIS has an equivalence program with foreign countries. Response: These are self-policing industries, so the economic consequences that deter producers from making mistakes are great. Page 7 of 18

8 Response: The FSIS certifies exported meat to US tolerances, but if countries have more stringent requirements, it is up to the industry to meet them. Comment: Some chemicals have a higher public health risk but you say a tolerance is your focus. Response: FSIS does not set the tolerances, but enforces those set (on the basis of public health risk) by FDA and EPA. Comment: Is it FSIS s goal to reduce drug-resistant pathogens? Is there a connection between residues and amounts of total actual antibiotic use? Response: Yes, the long-term goal is to reduce drug-resistant pathogens. At this time, FSIS is not using violation data to extrapolate and correlate with actual drug use. In any case, FSIS does not have usage data. Comment: What is the acute problem FSIS is focused on? Response: Both acute and chronic effects of drugs are important (e.g., an acute effect would be penicillin and sulfa drug allergies). Chronic effects are difficult to measure. Comment: How long ago were these tolerance levels set? Response: When the drug was first approved or the last major change in dosage regimen. Comment: How does FSIS determine its sampling algorithm? It seems that FSIS needs a strategic means for testing, not just testing for the sake of testing. Response: FSIS has prioritized which residues to test; however, they will capture both penicillin and gentamicin in the same method. Comment: Does FSIS regulate dairy products? Response: No. FDA is the agency that regulates dairy products. They are only looking for betalactams. CVM never sees those violations. Comment: It appears that you want to get the most value for your investment, but there is a limit to the number of samples the laboratories are able to run. For 9 billion birds, there are 2,000 tests to examine the prevalence of violation. What is the sensitivity for these sampling strategies? Response: Answer unknown. Comment: Is there any other way to deal with the violations, aside from better record keeping? Response: Should look at what behavior change you want in the producers. The industry structure and accountability differ among commodity groups (for example, feedlot beef); therefore sampling strategy needs to be different. FSIS Remarks: FSIS is an enforcement and public health agency. The list of what they test changes each year. An algorithm is developed based on public health considerations, and this is developed by their surveillance advisory team (an interagency group). The algorithm will be discussed tomorrow. There are certain questions in today s discussion that are broader than FSIS can handle, and the agency is currently in the process of a redesign. One question FSIS has is: what is the cumulative impact of drugs that are below tolerance? The current framework is unable to address that sort of question. Page 8 of 18

9 Friday, September 23, 2011 VII. Refocusing the Committee s Task Patty Bennett showed a PowerPoint slide (see Appendix) to reemphasize the primary questions the agency would like addressed. VIII. Identifying Emerging Contaminants in Livestock and Poultry Charles Santerre (Professor of Food Toxicology, Department of Foods and Nutrition, Purdue University) gave a presentation on ways to identify emerging contaminants (see Appendix for PowerPoint presentation). Items mentioned included: In the US, we are in a reactive mode when compounds are newly detected. Chemical contamination of food affects the industry because it is costly and reduces the confidence of the public in the industry. Chemical contamination primarily enters production at the preharvest stage, and this stage should be the focus. There are four types of chemical contaminants of concern namely: accidental contaminants, economic adulterants, unknown chemicals, and environmental contaminants. For each type, incidents were cited and the cost of these incidents to the industry was discussed. Food contamination affects consumer confidence on the industry and producers. Animals are important sentinels of food contamination. It is important to gather intelligence on emerging chemical contaminants although there are several challenges to accomplishing this goal. The discussion that followed included the following topics: Comment: Federal agency or agencies, industry, and academic institutions can all work together to gather intelligence. An advisory panel (composed of members from the agencies, industry, and academe) that will meet on a regular basis could help assess the current situation. Comment: Perhaps there should be improved food composition analysis to screen the food and also to check the claims that are being made by producers. Response: This (composition analysis) has been done before but the problem now is that there is not enough expertise in this field (chemical analysis of food) in the US. Comment: Is the national feed program coordinated with the NRP (because feeds are source of contamination)? Response: Feeds should be looked into because they are a major source of contaminants. Response: FDA has a feed contaminants program that addresses contaminants in feeds. Comment: A comment was also made about Dr. Santerre s suggestion to look for 10,000 chemicals perhaps most of them are benign and the public will only be scared by the mention of their detection. The shotgun approach may not be the best and care needs to be taken to not scare the public. Comment: A comment was also made about the TTC, about its hypothetical risk. Response: The TTC is needed for the instruments to do detection otherwise there is no way to see what is popping up until the animal dies. Page 9 of 18

10 Comment: There was also a comment on water as the source of contamination and the need to check water. IX. EU Monitoring Systems for Residues: The Role of EFSA Jordi Serratosa (Senior Officer, European Food Safety Authority (Liaison Officer with US FDA)) gave a presentation on residues in Europe (see Appendix for PowerPoint presentation). Items mentioned included: Main concerns in the EU: chemical products, pesticides, toxic substances, veterinary drugs, and food poisoning (Salmonella, etc). However, the concerns differ in each country of the EU, based on the culture and also on past experiences with contamination. In the US, the main concerns are (1) bacteria in food and (2) chemicals. US federal agencies and EU agencies that work on food residues. EFSA regulatory framework (all tolerances were revised in 1990; after 2002, a risk-based approach was adopted). The main role of EFSA is to analyze data and publish the results (interpret the data). It was mentioned that the system needs to help the inspector deal with the stress of suspecting contamination but having no way to prove it or block the product from entering the market. Challenges for EFSA: respect rules and MRL, the need for risk assessments, definition of pathways, understand the continuum concept. The discussion that followed included the following topics: Comment: It is good to be aware of what s going on at the international level. Is there is enough attribution data for contaminants entering preharvest? Response: Surveillance of residues is a preharvest issue for the EU and for each incident EFSA needs to understand how it (contaminant) got there. Comment: How is chemical testing prioritized? Response: Each member country decides which chemical to test for based on its own reasons. But one task of EFSA is to harmonize this process. Comment: How are emerging or potential risks assessed? Response: First, emerging risk needs to be defined and then indicators need to be determined, there needs to be a meeting to decide parameters to examine. Comment: During the melamine incident there were laboratories that shared information with each other and it is important to know what each other are doing and know our capacity to do things as a global unit. Response: Ranking (of important contaminants) and priority setting (for testing) should also take into consideration the local context with its constituency. Page 10 of 18

11 X. Open Discussion Comment: Has FSIS partnered with APHIS/NAHMS to help them with their surveys and to make use of their data? Response: Yes. FSIS staff has participated with NAHMS in their planning. However, it is a voluntary system. The questions that can be asked are limited and the information from their findings is made public. However, it is a source of information for FSIS. Response: USDA also is very much involved in the One Health Program. Comment: When FSIS meets with CDC/FDA/EPA for strategic planning is that with just the pesticide section of EPA or does it deal with broader EPA issues? Response: Mostly with the health effects division. The focus is on pesticides for which there are tolerances in edible tissue. Comment: How about heavy metals such as cadmium? Response: FSIS is just starting to look at heavy metals. Comment: How much of what you do is fixed by the regulatory role and how much discretion is there? Response: The priority has been on veterinary drugs and pesticides. However, the agency is very interested in adding to the list if there are important substances that animals are exposed to. Comment: There is a focus in toxicology today on biomonitoring and FSIS has the potential to be the sentinel for lipophilic contamination of the environment. Because in ground beef, for example, there is a sample that is about 20 minutes away from being in a person s body and ultimately in their fat. Response: That is a possibility. FSIS needs to be able to justify the testing that they do. How important is that relative to other things the agency needs to address? Response: Under the previous administration, endocrine disruptors were a major priority. The emphasis on that diminished for a while but is returning now. Comment: Focus on diseased animals and take a look at specific tissues in diseased animals to predict what humans may be exposed to. Examine the pathology of diseased animals and focus on what is revealed. Rare and unusual events are not likely to surface in the programmed testing. So, perhaps more focus on the diseased animals would be warranted. Comment: Is there a possibility of having part of the FSIS staff spend time to scope the environment and improve information service? Response: That may be a challenge to do in house, but may be able to partner with others to do this. Jurisdiction boundaries may also be an issue. Comment: Please explain the algorithm used so we can understand the priorities? Response: The algorithm takes into account the public health risk of each compound. We are changing the algorithm. We consider the production classes of concern. Once the optimized list is developed then there are practical issues (e.g., testing for residues vs. E. coli O157H7). There is information from CDC. Withdrawal times and toxicity are taken into account. Then the ranking is developed. Also the availability and development of methods is important. In general, the algorithm has not changed dramatically over the years. Some of the methods are old, so effort is expanded because of the methods. When tolerances are made, the method that is used becomes the gold standard. There can be bridging studies that can bring in new methods. There is a move away from the requirement to bridge and use performance-based criteria. This is not yet in place. Page 11 of 18

12 Comment: Lipid-soluble contaminants are important because they can be present for a long time. This would include PCB etc. and some pesticides. How important is public health in the algorithm? Response: It is a balance between the two [public health and enforcement of tolerance levels] and they cannot really be separated. Comment: We need to know where feed is made, how it is made, etc. More focus on the feed would be a good idea. Apparently antibiotic residues are a rare thing and therefore perhaps not a major public health concern. Response: Not all residues are accidental. Before testing was instituted, there were lots of positives; after testing considerably fewer. Many feed additives come from China. These are not thoroughly checked and could be a source of contamination. Comment: Let s think about your 10,000 chemicals proposal. Which ones should we screen for? Perhaps resources might be better focused on mounting a response when problem occurs instead of totally on prevention. Quality improvement how will you know if you ve done a good job? What metrics are used to determine if things are doing well? Are there measurable public health benefits? It would be good to revisit the scoring algorithm and see if it could serve as a platform to work in other factors. Response: We want this to be open-ended so you can help us think about what to consider. Comment: A high level recommendation is to develop some metrics. That drives incentives. Response: One of the difficulties is that there are many different sources of exposure and many of these FSIS has no control over. Multiple exposures are recognized to be a problem, but are difficult to quantify. Metrics are very important but difficult to measure. Comment: There are two principal concerns: public health and regulatory compliance. The solution could be two parallel approaches: (1) continue the NRP and (2) establish a feed program to consider public health impact from these contaminants getting into feed. Perhaps an early warning system on animal feed could be developed. Comment: The high level concept is perhaps to focus on quantifiable public health outcomes. If consumer confidence is a goal then test for 10,000 chemicals. If the primary goal is public health then come up with a list of known chemicals and a method to search for unknown ones and focus maybe 70% on known and then 30% on that approach for unknowns. Maybe focus on fat-soluble compounds. If you want to be considered a public health agency, you have to link what you do to public health. Response: I think it would be helpful for the FSIS group to get together and come back with additional responses this afternoon. Comment: I think you re doing what you re supposed to do in the plants; the planned residue monitoring part. I want to talk about response to problems. The agency will get a lot of credit for their response to chemical spills due to tornadoes, natural disasters, land application of biosolids. You can do this by making use of state health department data and state departments of environmental quality. The state departments know where these all are located because they are all licensed. The data could be matched with information from the Farm Services Administration and then within a certain radius check any animals that are being raised for residues of heavy metals or other toxic compounds. EPA has information on similar events. That kind of intelligence gathering would make the agency appear to be much more responsive. Comment: How does what the agency doing fit into a risk-based model? Thinking beyond the current regulatory framework may be helpful. Comment: How do FDA and EPA establish their priority list? Is there a model there for FSIS to follow? Page 12 of 18

13 Response: The animal feed safety system has a method and this is laid out on the website. Page 13 of 18

14 XI. Open Discussion Continued FSIS Remarks: We appreciate the inputs and comments from the committee. An emerging theme is whether our program is for public health or regulatory? We are doing both. We are a regulatory agency as we have established and are also a public health agency. The tolerances set for regulation are based on public health considerations. We cannot separate regulatory compliance from public health. We are the enforcement arm of FDA and EPA. Comment: Shall our recommendations be restricted to animal testing? FSIS Remarks: We collect meat samples, but we also need to collaborate with other agencies that have the capability to collect data in other areas and are able to inform us. We are developing exploratory assessments. The committee has already given us a good suggestion on conducting animal pathology. We have sophisticated equipment, but we don t have a systematic approach. We are interested in approaches to find information about where hazards would be. How can we best position ourselves to look for high hazards and those that most affect public health? Comment: Searching for residues is like trying to find a needle in a haystack. Not evident that best choice of expenses is finding a needle in the haystack or would you like us to assume that is your objective? Response: We are open to your suggestions. Would like to start with what we might do. It s hard to weigh the importance of any single exposure to 1 ppm tolerance. But if you eat it every day and it s there every day, maybe it becomes problematic. Also the issue of the multiple exposures is problematic. Comment: You should try to collect the usage data of antibiotics (in addition to sales of antibiotics). NAHMS is related to antibiotics. It can be used to guide regulation. Response: The recent GAO report has a section on current usage of antibiotics. Comment: Maybe go to AVMA meetings and pick up some knowledge there. Action level is important to FSIS. Try to reach out to the practitioner groups and industrial groups. Share what you do with them and learn from their practices. Examples are the bovine practitioners group and the chicken council. Response: Both FSIS and FDA representatives have interactions with these types of practitioners. FSIS has talked to practitioner group in a previous study. CVM meets with practitioner groups on a regular basis. Comment: Could you elaborate more about the prioritization of the compound list in the slide? Response: The chemicals are those that have been used on farms. Some are pesticides. Some are based on political considerations, but are rotated in and out. Comment: Is there a number of chemicals that are tested? Response: Yes. Need to check. There are different numbers of chemicals under different categories. Comment: What is the algorithm used for? Response: Prioritizing the chemicals for which we should test. Ranking is based on toxicity, exposure, and withdrawal time. We have rotated one chemical out because of years without finding anything. Comment: What do you want the algorithm to do? Response: Rank chemicals in terms of public health effect. Comment: What would be the impact if the program is cancelled tomorrow? Response: We won t know the exposure we have. Page 14 of 18

15 Comment: Why do we care? Response: People died and got sick from the chemicals acute issues. In long term, we cannot track the health problem to the food we eat chronic level. Response: If we stop testing, we d stop trade. But it is not just an economic issue because the other issues are looking to see that our food is safe. Comment: One issue is the use of animal drugs and chemicals as opposed to how often residues are detected. The frequency of detection should reflect the frequency of usage. Perhaps use should be more evaluated than it is. Penicillin in milk is a problem, but not in meat. How do you evaluate the detection of chemicals in terms of public health effect? Response: FSIS has documented really high levels of antibiotic, at a toxic level. It is better to quickly detect problems via quick sampling than having the baseline of finding no violation. Comment: To be approved for use all drugs have to go through trials. How many drugs have unknown effects? Response: When FDA/FSIS sets levels of concern, those levels = safety. Action level equates to safety. Comment: Are these tolerances arbitrarily set or based on study? Response: They are based heavily on scientific studies. They are extrapolated from chronic studies on animals. Assumptions on metabolism and public health are examined. We are trying to set guidelines for behaviors. We need to be careful about targeting one rather than the other chemicals. The specter of the agency taking action is what keeps people behaving. Comment: Are the numbers of samples different between public health and regulatory purposes? Response: You cannot test to compliance. We are looking at what are the good practices; trying to put quality into the whole system. Response: We do sample plants for public health. When violations are found, we make sure that their food products are not going into the market. The process is much bigger than we are. Each agency is covering one trunk of it. We encourage better behavior by our regulatory authority. Comment: If you are trying to protect people from cancer risk you need to make connections. Look at animal testing, or precursors (better). A decision tree for testing may be helpful. Comment: You cannot sample enough to find everything, but you can sample enough to change behaviors and help producers. Comment: Public health is not equivalent to regulation. You still have a lot of tolerances you don t test for. Which do you go after? That should come from a public health perspective rather than someone is in violation. Response: FSIS tests for certain drug residues because we know the drugs are available. But do we need to test for emerging substances? Perhaps connect with practitioners to know about their concerns and which drugs are they reaching for. Comment: Once new veterinary drugs are approved, are they automatically added on your list? Response: We need to validate the new drugs and new applications of drugs. We get a lot of intelligence from FDA. There are not many new veterinary drugs. Response: It is a thorough process. We test not only new drugs, but some old drugs that people switch back to. The extension of drug approvals to new species is a concern. Comment: Would it be useful to include practices before you get the hazard? Response: We have made some efforts to go to producers for factors influencing their behaviors. Page 15 of 18

16 Comment: The prevalence of certain behaviors may affect the prevalence of hazards. You may need to include the economic forces more formally in your models. Currently, there is no connection between the decision to test and frequency of the behaviors. Think about problems in behavior, how to deal with the emergence of the chemical uses from other countries, such as melamine. Comment: What is the impact of the program? How do you quantify the impact on behavior? What is the impact from your deterrence? Response: In 2009, we created a list of violations. The plants and industry were going wild. Recently some practitioners came back to ask for revision of the list it really draws attention to plants in violation. However, we still need to work with chronic offenders who have not been affected. Comment: Do offenders have short memories or there are other factors affecting their behaviors? How do you get the message heard? Response: We are thinking about how we connect with the industry to encourage them to make a good decision on food purchases. Response: The FSIS Residue Violation Information System is online. Comment: You could do a long-term social analysis; add some kind of surprise element. Comment: Interaction between one compound and other prevalent compounds could be important. For example, if there was an interaction of penicillin with other compounds, screening for those compounds would be valuable. Response: There are interactions among compounds, and between compounds and other food ingredients. Comment: The interacting compound could either enhance or diminish the effect of the substance found to be in violation. Comment: Regulatory thresholds are based on risk assessment. Once you have impact on behaviors, the differential of changes in risk can be evaluated using the risk assessment behind the threshold (i.e., a sensitivity analysis of risk, especially for chronic illness). Behaviors may have large differences in their impacts. Response: The industry uses risk assessment for drug testing. The issue is whether we can have access to the risk assessments. It will depend on whether they are proprietary. Comment: Was there an economic rationale behind the exercise that Dr. Santerre conducted to determine likely contaminants in the future? Response: It was based on the likely scenario for an adulterant. The approach is to find out a critical control point and work on it. Once the expensive options (substitutions for protein, for example) were eliminated, there seemed to be less of an economic case that other nutrients would be mimicked using adulterants. In that sense it was an analysis of what would be likely to be an economic adulterant. Comment: What is the international and domestic market effect of compounds that create residue violations? Response: DHS, FDA, etc. are working with universities to investigate the economic incentives to use adulterants of one kind or another. Page 16 of 18

17 Abbreviations AMR APHIS AVMA CDC CVM DHS EFSA EPA EU FAS FAST FDA GAO HAACP KIS MRL NAHMS NPIP NRP OIG PCB ppm PQA TTC USDA VS Anti-Microbial Residue Animal and Plant Health Inspection Service American Veterinary Medical Association Centers for Disease Control Center for Veterinary Medicine Department of Homeland Security European Food Safety Authority Environmental Protection Agency European Union Foreign Agricultural Service Fast Antimicrobial Screen Test Food and Drug Administration Government Accountabilities Office Hazard Analysis and Critical Control Points Kidney Inhibition Swab [Test] Maximum Residue Limit National Animal Health Monitoring System National Poultry Improvement Plan National Residue Program Office of Inspector General Polychlorinated biphenyl Parts per million Pork Quality Assurance Tetracycline hydrochloride United States Department of Agriculture Veterinary Services Page 17 of 18

18 Appendix Page 18 of 18

19 10/5/2011 FSIS Mission National Residue Program Food Safety & Inspection Service To ensure that meat, poultry, and processed egg products distributed in commerce for use as human food are safe, wholesome, and accurately labeled. P Bennett, DVM, MS, DACVPM, MPP Food Safety and Inspection Service 22 September FSIS Activities 9,600 FSIS employees Nearly 8,000 Office of Field Operations employees 7,730 front line employees, including 6,600 inspectors 800 veterinarians 3 FSIS Activities 6,200 Federal plants (800 livestock slaughter) Inspect 150 million livestock and 9 billion birds each year Egg products billion pounds Agency also inspects allied industries custom exempt, warehouses Import Houses 4 1

20 10/5/2011 Production classes under FSIS regulatory authority: Cattle: bulls, beef cows, dairy cows, heifers, steers, bob b veal calves, formula-fed veal calves, non formula-fed calves, heavy calves Swine: market hogs, roaster pigs, boars, sows, Sheep, lambs Goats Poultry: young chickens, mature chickens, young turkeys, mature turkeys, ducks, geese Egg products National Residue Program 5 6 Interagency Program Interagency Program Memorandum of Understanding 1984 FSIS, AMS, FDA, and EPA Provides authority for the Surveillance Advisory Team (SAT) Provides authority for Interagency Residue Control Group (IRCG) 7 Food and Drug Administration (FDA) Establishes Tolerances Approves feed and drug usage Regulatory action: on-farm Environmental Protection Agency (EPA) Establishes Tolerances Food Safety and Inspection Service (FSIS) Prevents Chemically Adulterated Product from entering Food Supply Regulatory action: establishment 8 2

21 10/5/2011 National Residue Program Ensure meat, poultry, and egg products are safe from chemical residue violations Systematically sample and analyze imported and domestic products Residue Sampling Plans Verify that plants are fulfilling their responsibilities under HACCP 9 10 Sampling Plans in the NRP Domestic Sampling Plan Scheduled Sampling Inspector Generated Sampling Import Sampling Plan Normal Sampling Increased Sampling Intensified Sampling 11 Domestic Sampling Plan Scheduled Sampling Exposure Assessments Exploratory Assessments Note: Random Sampling Inspector Generated Sampling Individual Suspect Animal Suspect Population or Slaughter Class- directed by regulation, directive or notice Note: Target Sampling 12 3

22 10/5/2011 Compounds in 2010 NRP Blue Book/Red Book - NRP Antibiotics (bioassay) Arsenic Avermectins Beta Agonists Carbadox Chloramphenicol CHC/COP Florfenicol Flunixin Lead and Cadmium Nitrofurans Nitroimidazoles Sulfonamides Thyreostats Trenbolone Zeranol ue_book/index.asp Book.pdf Fast Antimicrobial Screen Test (FAST) & Kidney Inhibition Swab Test (KIS ) Testing Procedures Antibiotic detection tests for fresh or thawed kidney tissue FAST is an adaptation of the antimicrobial screening test that has been used in FSIS laboratories for many years KIS Test implemented in all cattle classes and now implemented in some swine plants starting 11 September

23 10/5/2011 FAST vs. KIS Test FAST KIS Organism B. megaterium B. stearothermophilus Test Media Swab/Plate Swab/Test Tube Equipment Air Incubator Dry Well Heating Block Temperature 44 ± 1 C 64 ± 2 C NRP Sampling Results Time 6-18 hr 3-16 hr 18 Samples by Animal class by CY Inspector Generated Samples by Animal class by CY Domestic Scheduled Production Class Number of Samples (In-plant Screening) Number of Confirmed Lab violations Number of Samples (In-plant Screening) Number of Confirmed Lab violations Number of Samples (In-plant Screening) Number of Confirmed Lab violations Production Class Number of Samples Number of Confirmed Lab violations Number of Samples Number of Confirmed Lab violations Number of Samples Number of Confirmed Lab violations Beef* 12, , , Beef* 3, , ,065 1 Bob veal 27, , , Bob veal Dairy cows 94, , , Dairy cows 2, , ,837 1 Market Hogs 6, , ,185 0 Chickens 1, , ,430 0 Sows 1, , ,676 1 Market Hogs 1, , ,610 1 Sows , Total 142,362 1, ,619 1, ,054 1,070 Turkeys 1, ,357 0 Total 10, , ,477 5 * Beef includes : Beef Cows, Heifers, and Steers * Beef includes : Beef Cows, Heifers, and Steers

24 10/5/2011 Top Violative Residue Per production class by CY - National Residue Program Production Class Beef* Bob veal Dairy cows Market Hogs Top Violative Compounds 2007 Penicillin, Sulfamethazine and Flunixin Neomycin, Flunixin, and Penicillin Penicillin, Flunixin, and Sulfadimethoxine N/A Top Violative Compounds 2008 Penicillin, Gentamycin Sulfate, and Sulfamethazine Neomycin, Flunixin, and Penicillin Penicillin, Flunixin, and Sulfadimethoxine Gentamycin Sulfate, and Sulfamethazine Top Violative Compounds 2009 Penicillin, Gentamycin Sulfate, and Tilmicosin Neomycin, Gentamycin Sulfate, and Sulfadimethoxazole Flunixin, Penicillin, and Sulfadimethoxine N/A Proposed Changes to NRP Current Sampling Plan 2011 Compound by production class pairing Samples tested for limited number of chemicals Proposed Sampling Plan 2012 Multi-analytic methods 1 sample screened for several chemicals * Beef includes : Beef Cows, Heifers, and Steers Knowledge Gaps What does industry need in order to treat production animals effectively? How does industry decide which drugs to use for which purpose? Given that some uses are off-label, what advice should be given to producers on how to avoid illegal use of off-label drugs? Knowledge Gaps GAO Recommendations (GAO ) Identify and evaluate approaches to collecting detailed data on antibiotic use in animals Collect more representative data on resistance

25 10/5/2011 QUESTIONS? 25 7

26 FDA/CVM Div. of Compliance FDA Drug Residue Program Neal Bataller, ME, DVM Director of Surveillance FDA/Center for Veterinary Medicine A drug residue is Any compound present in the edible tissues of an animal that results from the use of the drug Edible tissues are muscle (meat), liver, kidney, fat, milk, and eggs Any compound means the drug itself, its metabolites, or any substance formed in or on edible tissue as a result of the use of the drug FDA/CVM 1 FDA/CVM 2 Acute Effects Fairly immediate reaction (usually within 7 14 days) to single dose exposure May be reversible Very few volatile animal drug residues in food have acute (immediate, sometimes lifethreatening) effects on human health but some do Usually occur at higher doses than chronic effects Beta-agonists such as clenbuterol/ ractopamine/zilpaterol Increased heart rate, muscle tremors, headache, nausea, dizziness, fever and chills Penicillin/sulfa drugs Allergenic reactions, including swelling, shock, skin rashes, asthma and fever FDA/CVM 3 FDA/CVM 4 08/02/00 1

27 FDA/CVM Div. of Compliance Chronic Effects Occur after prolonged, repeated exposures Symptoms usually not immediately apparent and may be irreversible after a period of time, contributing to organ failure, disability and death Apparently mild chronic effects seen in toxicity studies may be markers for more significant effects in larger populations or at higher doses Health effects are very difficult to attribute to a single, chronic source, such as animal drug residues Chronic exposure to animal drug residues may contribute to health problems (e.g., liver or kidney failure), but may not be the sole cause of such problems FDA/CVM 5 FDA/CVM 6 Flunixin Decreased body weight gain, hemoglobin, hematocrit, serum total protein and albumin in monkeys Gastrointestinal erosion/ulceration and renal papillary p necrosis in rats Mutagenic in mouse lymphoma cells Pirlimycin Reductions in serum protein and globulin levels in rats Gastric irritation in beagle dogs Hazard: Residue Toxicity (RT) Acceptable Daily Intake (ADI) Drug Not approved for food animals AMDUCA-prohibited drug Human Carcinogen Likelihood of Exposure: Firm Violation Frequency (VF) Exposure Level Tolerance Exceedance (TE) FDA/CVM 7 FDA/CVM 8 08/02/00 2

28 FDA/CVM Div. of Compliance RT/5 + VF/5 + TE/8 = RISK SCORE Hazard Residue Toxicity 1 Residue with high ADI > 50 µg/kg/day 2 10 < ADI 50 µg/kg/day Low High Risk < ADI 10 µg/kg/day 0.2 < ADI 3 µg/kg/day 5 Residue with low ADI < 0.2 µg/kg/day or Drug not approved for food animals or AMDUCAprohibited drug or Human Carcinogen Likelihood of Exposure Violation Frequency Exposure Level Tolerance Exceedance Current Violation: 1 animal; 1 residue /animal 1 10X 2 10X 20X Current Violations: >1 animal; 1 residue /animal 3 20X 30X 4 30X 40X Current Violations: 1 animal; >1 residues /animal 5 40X 50X Previous violation(s) prior to 1 year ago 6 50X 100X Previous regulatory action or Previous violation(s) within 1 year X 250X >250X tolerance CVM issues an assignment to the appropriate District Office requesting an FDA on-site inspection be conducted when the risk score of the residue reported by FSIS exceeds the annually calculated FDA risk threshold. District Program Monitor will issue assignments to cooperating State Agencies for as many of the residues below the FDA risk threshold as cooperative agreements allow. FDA/CVM 9 FDA/CVM 10 FDA and/or State inspection based on risk ranking Documentary sample collection Affidavits Complete Attachments C & G Issue Notice of Adverse Findings (FD-483) Write up Establishment Inspection Report (EIR) Recommend enforcement action as appropriate Obtain supervisory concurrence on recommendation Case sent to District Compliance Officer District Compliance Officer drafts charges Case sent to CVM Compliance Officer for review Case sent to OGC for final concurrence Action taken FDA/CVM 11 FDA/CVM 12 08/02/00 3

29 FDA/CVM Div. of Compliance Communication Warning Letters Untitled Letters Injunctive Actions Contempt Actions FY-07 FY-08 FY-09 FY-10 Interagency Residue Control Group (IRCG) Surveillance Advisory Team FSIS District Conferences Veterinary Field Committee Quarterly Conference Calls with District Program Monitors FDA/CVM 13 FDA/CVM 14 Databases Residue Violation Information System (RVIS) Information on FSIS Sampling & Results TISSUE RESIDUES IN DAIRY CATTLE - RVIS DRUG Total Percent Amikacin % Ampicillin % Ceftiofur * * * % Dihydrostreptomycin % Florfenicol % Flunixin % Furazolidone % Gentamicin % Kanamycin % Lincomycin % FDA/CVM 15 08/02/00 4

30 FDA/CVM Div. of Compliance TISSUE RESIDUES IN DAIRY CATTLE - RVIS DRUG Total Percent Neomycin % Oxytetracycline % Penicillin % Phenylbutazone % Sulfachlorpyridazine % Sulfadimethoxine % Sulfamethazine % Sulfathiazole % Tetracycline % Tilmicosin % Tylosin % * Prior to July 28, 2008 USDA could not quantitate Cefiofur Tissue Residue Information Management System (TRIMS) Information on Federal and State t inspectional findings Ensures Consistent Data Collection Characterizes causes for residue violations FDA/CVM 18 An Interactive Database Containing Information Obtained During FDA/State Inspections of Firms Involved/Responsible for Tissue Residue Violations. Attachment C Ensures Consistent Data Collection by both Federal and State Investigators. Attachment C Data Entered into TRIMS Preventive 12% Reason Drug Used - FY08 FDA/CVM 19 FDA/CVM Illness 88% /02/00 5

31 FDA/CVM Div. of Compliance Treatment Records Not Maintained Failure to Maintain Animal Id Withdrawal Time Not Followed Exceeded Approved Dose FDA/CVM Extra Label Use by Laymen Could Not Determine 21 A1- Animal fed colostrum A2- Animal fed medicated feed by mistake A3- Drug given by mistake A4-Failure to maintain animal id & medication records A5- Inadequate animal segregation A6- Failure to follow withdrawal time A7- Feed manufacturing cgmps B1- Vet s prescribed withdrawal time not followed B2- Vet s verbal withdrawal time not followed B3- Animal treated with higher dose B4- Labeled route of administration not followed B5- No withdrawal period prescribed B6- Drug not approved for species B7- Frequency different than labeled B8- Duration of treatment longer than labeled C- Could not Determine D- Drug not same as reported by FSIS E- Told purchaser that animal was medicated and it was later diverted F- All labeled directions followed and documented G. Miscellaneous other causes FDA/CVM A1A2A3A4A5A6 B1 B2 B3B4B5B6B7B8 C D E F G Yes 30% FY08 0 No 70% FDA/CVM 23 FDA/CVM 24 08/02/00 6

32 FDA/CVM Div. of Compliance Quantity Marketed Antimicrobial Animal Drug Marketed Required for all approved animal drugs Total number of distributed ib t d units of each size, strength, or potency Quantities distributed domestically and quantities exported Facilitates assessment of adverse events Required for all approved antimicrobial drugs for food-producing animals For the same calendar year Amount of active ingredient Summary report for the public Facilitates monitoring of antimicrobial resistance FDA/CVM 25 FDA/CVM 26 Marketed Food Animal Antibiotics Annual Totals (kg) Antimicrobial Class 2009 Aminoglycosides 339,678 Cephalosporins 41,328 Ionophores 3,740,627 Lincosamides 115,837 Domestic D Macrolides M 861,985 Penicillins 610,514 Sulfas 517,873 Tetracyclines 4,611,892 NIR 2,227,366 Tetracyclines 515,819 Export NIRE 1,115,728 Questions? FDA/CVM 27 FDA/CVM 28 08/02/00 7

33 10/4/2011 Questions to answer Chemical use in Pork Production H. Scott Hurd College of Veterinary Medicine, Department of Production Animal Medicine Former Deputy Undersecretary of Food Safety, USDA Director of World Health Organization Collaborating Center for Risk Analysis and Hazard Surveillance and Intervention in Food Animals Co-Director Collaboration for Comparative Outcomes Research Evaluation (CCORE), Iowa State University, Ames IA What does the industry need to treat animals effectively? Why does industry reach for the products they reach for? Given that some uses are illegal/ off-label, what advice would we give producers on how to avoid residues? In short, can you help us (FSIS) understand/identify the underlying problems relative to chemotherapeutic uses? 2 What does the food animal (pork) industry need to treat animals effectively? Opinions of multiple swine practitioners Treatment for Erysipelothrix rhusiopathiae is Extra-label More products and antibiotic classes Single dose products with short withdrawal Methods for early identification of sick pigs Objective measure of effectiveness and length of treatment Many new labels for existing drugs Label = FDA approved route, dose, and pathogen e.g. Penicillin for Erysipelothrix insidiosa in swine Multi-Site Production Breeding-Gestation Farrowing >100 m Nursery N N N >100 m F Finishing F F F F F F 3 1

34 10/4/2011 Why does industry reach for the products they reach for? Farm or flow history Necropsy Lab results (pathogen, histopathology) Culture and Sensitivity Routine surveillance (serology data) The products that work??? It is the only option Cost/benefit or Outcomes analysis - occasionally Preweaning piglet death NAHMS Swine Survey Pig causes of death Treatment protocols on most farms Developed by consulting veterinarian Respiratory problems are major cause of death, same for growfinish pigs 7 Real example from major pork producer 8 2

35 10/4/2011 Growth promotion v. Prevention v. Therapy Three general areas of antibiotic use Purpose NOT Route Types of IN FEED antibiotics used Growth Promotion production uses, nontherapeutic, no specific disease or pathogen Prevention Before clinical signs, based on history FDA considers uses that are associated with the treatment, control, or prevention of specific diseases, including administration through feed and water, to be uses that are necessary for assuring the health of food producing animals FDA believes that some prevention indications are necessary and judicious (FDA Draft Guidance 209) Treatment overt illness, death, pathogen identification Not listed in FDA 152 Bacitracin Bacitracin Zinc Bambermycins Carbadox Roxarsone withdraw from market Sulfamethazine Sulfathiazole Tiamulin Highly or critically important Chlortetracycline Lincomycin Neomycin Penicillin Virginiamycin Tilmicosin Tylosin Not a measure of public health risk from resistance or residues 9 See upcoming paper by M Apley in Foodborne Pathogens and Diseases 10 Antibiotic use For growth promo, prevention and treatment For prevention and treatment

36 10/4/2011 Given that some uses are illegal, what advice would we give producers on how to avoid illegal use of drugs? Intentional Illegal use is RARE Given that some uses are extra label, what advice would we give producers on how to avoid residues These are big businesses, cannot take a risk Large investment in the farm Most have their name on the product Extra label l use in feed is NOT PERMITTED in U.S Head veterinarian reviews protocols routinely Drugs not allowed for EDLU Drugs Prohibited for Extralabel Use in Food Animals (Current as of June Check for updates on the FDA Web site atwww.fda.gov/cvm) Chloramphenicol Clenbuterol Diethylstilbestrol (DES) Dimetridazole Ipronidazole Other Nitroimidazoles Furazolidone, Nitrofurazone, Other Nitrofurans Sulfonamide drugs in lactating dairy cows (except approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine) Fluoroquinolones Glycopeptides (example: vancomycin) Phenybutazone in female dairy cattle 20 months of age or older Adamantane and neuraminidase inhibitor classes of drugs that are approved for treating or preventing influenza A are prohibited therapy in chickens, turkeys, and ducks (Effective: June 20, 2006) 15 Extra label drug use is allowed for NONfeed antimicrobials From the American Veterinary Medical Association REQUIREMENTS FOR USE ELDU is permitted only by or under the supervision of a veterinarian. ELDU is allowed only for FDA approved animal and human drugs. A valid Veterinarian/Client/Patient Relationship is a prerequisite for all ELDU. ELDU for therapeutic purposes only (animal's health is suffering or threatened). Not drugs for production use. Rules apply to dosage form drugs and drugs administered in water. ELDU in feed is prohibited. ELDU is not permitted if it results in a violative food residue, or any residue which may present a risk to public health. FDA prohibition of a specific ELDU precludes such use. (See gray box below 16 4

37 10/4/2011 Quality Assurance A Program for America s Pork Producers 17 PQA Plus required by > 95% of packers GPP #1 Establish and implement an efficient and effective herd health management plan. GPP #2 Use a veterinarian/client/patient relationship (VCPR) as the basis for medication decision-making. GPP #3 Use antibiotics responsibly. GPP #4 Identify and track all treated animals. GPP #5 Maintain medication and treatment records. GPP #6 Properly store, label, and account for all drug products and medicated feeds. GPP #7 Educate all animal caretakers on proper administration techniques, needle-use, withdrawal times, etc GPP #8 Follow appropriate on-farm feed processing and commercial feed processor procedures. GPP #9 Develop, implement, and document an animal caretaker training program. PQA Plus required by > 95% of packers GPP #6 Properly store, label, and account for all drug products and medicated feeds. GPP #7 Educate all animal caretakers on proper administration techniques, needle-use, withdrawal times, etc GPP #8 Follow appropriate on-farm feed processing and commercial feed processor procedures. GPP #9 Develop, implement, and document an animal caretaker training program. GPP #10 Provide proper swine care to improve swine well-being. When residues occur, it is an ACCIDENT, mistake, outlier. 5

38 10/4/2011 Help (FSIS) understand/identify the underlying problems relative to chemotherapeutic uses? Shortage of new and effective anti-infectives Route of administration and dose data are LIMITED Veterinary Feed Directive does not allow Extra Label Change of FDA approved label is costly and dangerous Increase information on withdrawal times for different doses, routes etc. Conflict between welfare (need to treat) and withdrawal SUMMARY What does the industry need to treat animals effectively? More products Better information on how to use existing products wider labels Why does industry reach for the products they reach for? Lab work, history, professional judgment No other choice SUMMARY Given that some uses are off-label, what advice would we give producers on how to avoid residues? Add more to withdrawal times Be careful with amount put in an animal In short, can you help us (FSIS) understand/identify the underlying problems relative to chemotherapeutic uses? Get on the farm Seek 1 st to understand 23 6

39 The United States Poultry Industry Birds Number Pounds Young Chickens 8,544,285,285 47,776,488,239 Mature Chickens 138,692, ,037,624 Young Turkeys 245,590,672 7,099,906,243 Mature Turkeys 1,810,634, 47,820,431, Residue Avoidance Ducks 22,896, ,923,719 C. Stephen Roney DVM, MAM Director, National Poultry Improvement Plan U.S. Department of Agriculture Animal and Plant Health Inspection Service Veterinary Services September 22, 2011 Safeguarding Animal Health 1 Geese 178,434 2,489,307 Other Fowl 2,953,823 2,923,171 SUBTOTAL 8,956,407,690 55,879,588,734 Safeguarding Animal Health 2 Consumption - Pounds Per Capita Broiler Industry Changes U.S. Annual Per Capita a Consumption (in lbs.) f CAGR ( 80 04) Chicken = +2.3% Beef = -0.6% Pork = -0.4% Percent of Produ uction U. S. Broiler Production 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Billions of Broile ers whole cut-up further # Broilers (billions) Per capita consumption has grown consistently for 25 years Safeguarding Animal Health Safeguarding Animal Health 1

40 Poultry Production Integrated production scheme Same company owns birds, feed mill, processing plant, associated capital Pays for feed, vaccinations, medications, etc. Contract growers own farms and raise birds for the company Commercial broilers, turkeys and table-egg layers Primary breeding companies have mostly company owned farms, few contract growers. Safeguarding Animal Health Vertical Integration Overview Pullet Average complex in the industry today processes about 1.2 million broiler chickens per week. Breeder Hatchery Debone Product Formed Cook Freeze Growout Primary Processing Safeguarding PackageAnimal Health Feed Mill Inject & Package Pullet These are baby breeder chickens bought from companies who improve chicken genetics. Average complex has about 40 Pullet Houses. Pullets (and Breeders) are 10% Male, 90% Female Baby pullets raised for 20 weeks then moved to breeder houses. Breeder Breeders are raised in specialized houses. The average complex also has about 40 breeder houses where the hens are bred for eggs. These hens lay eggs that become chickens. 400,000 hens make 260,000 eggs/day One hen produces 160 hatching eggs per lifetime. Breed for weeks, sold as spent hens. Safeguarding Animal Health Safeguarding Animal Health 2

41 Hatchery Hatch fertile eggs received from breeder farms. Eggs placed in incubators for 18 days and carefully monitored. Average Temp is F 82% hatching rate for eggs. Extra unneeded eggs sold as brown eggs. Safeguarding Animal Health Feed Mill Convert ingredients into finished feed. Main Feed Ingredients for a complex: 5,000 tons of Corn per week 1,000 tons of Soybean Meal per week 1.75 pounds of feed are needed for every 1 pound of chicken No growth hormones ever used Deliver to farms usually within a 50 mile delivery radius around the feed mill. Safeguarding Animal Health FEED ADDITIVE COMPENDIUM FDA/CVM- 21 CFR REGISTERED FEED MILLS-SUBJECT TO INSPECTION APPROVED DRUGS APPROVED SPECIES AND TYPE APPROVED LEVELS AND COMBINATIONS SPECIFIED WITHDRAWAL TIMES Safeguarding Animal Health 11 Safeguarding Animal Health 12 3

42 Growout Farms Newly hatched chickens transported by processor to growout farms. Processor owns the chickens. Farmers own the houses ($200,000+/house investment today) and are paid to raise chickens to market weight pounds ave. live weight Takes 5-7 weeks to raise to slaughter weight Processor provides chickens, feed, vets About 300 broiler houses per complex 25,000 chickens raised per house Housing standards well ventilated with room to grow, no cages. Safeguarding Animal Health Bio-Security Program Restrict visitors on farms Post bilingual bio-security procedures and no trespassing signage Safeguarding Animal Health BROILER FEEDS STARTER DAYS GROWER DAYS FINISHER DAYS WITHDRAWAL 33-38(63) DAYS PESTICIDE RESIDUE MONITORING PROGRAM BIRD ABDOMINAL FAT SAMPLES- 6/FARM/2/HOUSE--ALL RESULTS MUST BE RECORDED BEFORE PROCESSING ANY SUSPECT OF PESTICIDE RESIDUE PROMPTS RETESTING BEFORE BIRDS SLAUGHTERED COMMONLY USED PRODUCTS- IONOPHORE ANTICOCCIDIAL CHEMICAL ANTICOCCIDIAL BACITRACIN VIRGINIAMYCIN ROXARSONE ** 3-4 WEEKS MAYBE TIL PROCESSING FEED INGREDIENTS-LIQUID FAT, ANIMAL PROTEINS, BAKERY MEAL, WHEAT MIDS POULTRY HOUSE SOIL- 6 SAMPLES/PAD AT NEW CONSTRUCTION LITTER- SUPPLY TESTED EVERY SIX MONTHS Safeguarding Animal Health 15 Safeguarding Animal Health 16 4

43 Processing Plant Eviscerated whole bird weight is 72% of live weight Enhanced Security RESIDUE AVOIDANCE SOPs BREEDERS- DRUG USE = 2X WD TIME NO SYSTEMIC ANTIBIOTICS IN BROILERS DISINFECTANTS LABEL DIRECTIONS/APPROVED-GROWERS SUBJECT TO TERMINATION PESTICIDES LABELED AND APPROVED PESTICIDES STORED SEPARATE FROM MEDICATIONS PESTICIDE TESTING-BIRDS/SOIL/FEED PLANT- RANDOM FAT SAMPLES PLANT- SECURITY Safeguarding Animal Health Safeguarding Animal Health 18 Questions? Safeguarding Animal Health 19 5

44 Emerging Which Hazards?? Pre Harvest Priority Ranking Algorithm sample #s/sample size Testing Tolerance/Action Levels Decisions

45 10/4/2011 Overview Use of Public Health Data in FSIS Food Safety Programs: Identifying Emerging Contaminants in Livestock and Poultry Where chemical contaminants enter foods Chemicals of concern Gathering intelligence on emerging chemicals Identifying high risk contaminants Challenges we face Charles R. Santerre, Purdue University 1 2 Where do chemicals and pathogens enter the food system for livestock and poultry? Pathogens Production Processing Storage & Distribution Chemicals Retail & Home Preparation Which chemical contaminants are a concern in livestock and poultry products (excluding veterinary drugs)? Cases Accidental contaminants e.g., industrial oil Economic adulterants e.g., melamine Unknown chemicals e.g., used restaurant oil Environmental contaminants e.g., cadmium 3 4 1

46 10/4/2011 German Feed Contamination Accidental Contaminants Random testing of eggs Dec 10 found high dioxin levels Contaminated oil had 77x the limit for dioxins ~150,000 tons of feed involved Sales from 4,700 farms suspended causing losses of $70 million/week Lost exports - S. Korea suspended pork; Slovakia, eggs/poultry; China, pork Contamination by industrial oil may have dated back to March 10 Every animal-feed manufacturer should be forced to carry out dioxin tests (Foodwatch) 5 6 Belgian PCB/Dioxin Incident Accidental contamination of spent oil 99 Transformer oil (~100 L) added to feed as recycled food-grade oil Fed to poultry and swine Animal illness - chick edema disease; swine not affected PCB/Dioxin concentrations ~250x limits Past Feed Episodes 69 AK; poultry; heptachlor; $4 mil (estimated cost) MS; cattle; dieldrin; $50k OR; cattle; dieldrin; $250k 70 NY; ;poultry; dieldrin; ;$ $500k NM; swine; mercury; $63k 71 NC; swine; dieldrin; $10k NY; poultry; PCB; $1 mil SE US; poultry; PCB; $2.5 mil CA; poultry; PCB; $50k GA; poultry; dieldrin; $2.5k Reich AJPH. 73(3):

47 10/4/2011 Past Feed Episodes Past Feed Episodes 72 ME; poultry; PCB; $3 mil (estimated cost) MN; poultry; PCB; $336k ME; poultry; dieldrin; $150k MO; poultry; dieldrin; $78k CA; poultry; dieldrin; $90k 73 NC; poultry; chlordane; $2 mil NC; poultry; dieldrin; $88k CA; lambs; HCB; $25k MO; poultry; PCB; $567k LA; cattle; HCB; $400k MS; poultry; dieldrin; $6.9 mil Reich AJPH. 73(3): MI; cattle/dairy; PBB; $215 million (estimated cost) lbs of flame retardant added to cattle feed Exposed 9 million consumers 82 HI; dairy cows; heptachlor; $10 mil* Contaminated pineapple mash added d to feed 86 AR; cattle; heptachlor and chlordane; $16 mil* Pesticide-treated seed added to feed 89 AR; poultry; heptachlor; $5 mil* Contaminated grain 9 *Basu Proc. US An. Health Assn. : Past Feed Episodes 97 U.S.; chicken, eggs, catfish from dioxin-contaminated ball clay (anti-caking feed additive) 06 Bangladesh; fried foods Transformer oil containing PCBs contaminated cooking oil used in roadside shops Unscrupulous edible oil traders have been buying used transformer oil and mixing it with edible oil (Bangladesh News) Economic Adulterants

48 10/4/2011 Melamine 2008 Melamine U.S. dogs and cats suffered renal failure following consumption of pet foods containing melaminecontaminated wheat flour Melamine was added to wheat flour to increase its apparent protein content and thereby mimic wheat gluten More than 50,000 cases of kidney stones (nephrolithiasis) had been reported in China and linked to consumption of melamine-contaminated powdered infant formula FDA discovered that melamine reacts with cyuranic acid to form crystals in the kidney melamine melamine cyanurate crystals in kidney cyanuric acid Photo from NTP; Melamine Tests conducted in China on samples of the powdered infant formula found 0.1 2,500 ppm melamine. FDA initially set the Tolerable Daily Intake (TDI) at 0.63 mg melamine/kg bw-day day. Due to interactions between melamine and melamine analogs (e.g., cyanuric acid), FDA added an additional 10-fold uncertainty factor to the TDI - to mg melamine + melamine analogs/kg bw-day. Unknown Chemicals

49 10/4/2011 Used Restaurant Oil Used Restaurant Oil Grease types: White Grease = rendered from swine ($0.35/lb) Yellow Grease = includes used-restaurant oil and possibly lower grades of tallow ($ /lb) Brown Grease = collected from grease traps in commercial, industrial food processing or municipal sewage facilities ($ /lb) /lb) Annual production of Yellow Grease: 2.6 billion lbs/yr (2000) Est. 9 lbs./person-yr (1998) 47% exported Most Yellow Grease is added to animal feed; primarily for swine, poultry (egg layers, broilers, turkeys), and farmed fish Controls dust in barns which can carry diseases 1% in feed by 40% 2% in feed by 60% Energy source Swine, 5-6% fat except during hotter seasons, up to 10% Poultry, 2-3% fat Processing aid At low concentrations, may be added to beef cattle diets to prevent clogging of the extruder die Biodiesel Not the best source since by-product glycerol must be disposed of after spent oil is processed. Glycerol is often used as a dust suppressant on dirt roads Used Restaurant Oil Polycyclic aromatic hydrocarbons (PAHs) products of incomplete combustion of organic products Heterocyclic amines (HCAs) products of creatine and amino acids formed during heating of meat and poultry. Of the 19 mutagenic HCAs, 10 are carcinogenic (liver, mammary gland, small and large intestine, etc.) Maillard reaction products formed during the heating of reducing sugars and amino acids Nitrosamines products of nitrites and secondary amines in acidic or high temperatures Other products acrolein Environmental Contaminants

50 10/4/2011 Cadmium N Positive count* Positive % Mean (ppm) Median (ppm) Max. (ppm) 3465 Beef Cow Kidney Muscle Dairy Cow Kidney Muscle Market Hogs Kidney Muscle Mature Chicken How should we gather intelligence on emerging chemical contaminants? Conduct exploratory assessments and scan for unexpected compounds w/ lab instruments Monitor popular press, regulatory and scientific reports Communicate with domestic and foreign regulatory agencies to ID contaminants or significant scientific studies ie i.e., EFSA s Emerging Risk Identification (EMRISK) Program Encourage FSIS and FDA field staff to identify vulnerabilities Kidney Muscle Steer Kidney Muscle * The number of animals with residues above the limit of detection (0.010 ppm for cadmium ). (data courtesy of FSIS, 2011) Identifying High Risk Contaminants High relative chronic toxicity toxic at lower concentrations Polarity fat soluble Delayed biological effects i.e., cancer Thermally stable i.e., can survive cooking Lower toxicity in animals i.e., no canary Costly and/or slow to analyze i.e., makes source difficult to identify through trace back (e.g., dioxin, PCBs, PBDEs) Minimal affect on taste and aroma Identifying High Risk Contaminants Past foodborne episodes involving the contaminant (e.g., PCBs, dioxins, PBBs) High probability that compound is found where spent oil is produced or processed i.e., accidental cross-contamination (e.g., PBBs) Public fear (i.e., carcinogen, radioisotope) Economic incentive i.e., use in feed to avoid disposal cost (e.g., transformer oil) Accessibility easy to obtain Not typically found in food. Thus, we don t look for it (e.g., melamine)

51 10/4/2011 Challenges Conclusions Develop a regulatory response for chemicals that pose an unacceptable health risk to consumers and for which there are no Action Levels or Tolerances. Improve our analytical methods to allow us to rapidly scan for 10, chemicals at lower detection limits. Implement the use of a Threshold of Toxicological Concern (TTC) below which, the risk to consumers from most chemicals is negligible. The TTC is an approach for limiting the concentration of any chemical in food products to a daily exposure of 1.5 µg. 25 Chemicals typically enter our meat, poultry and egg products from the animal s diet and this is where our first line of defense should be established Chemicals may be present in these products due to intentional or accidental addition Improved analytical methods are needed to scan for the 100,000 1 million chemicals that are found in our foods Exploratory assessments are needed to find emerging chemicals and also to estimate human exposure We should identify high risk chemicals and use rapid assays to detect their presence Intelligence gathering is critical and it requires high level coordination between all state, national, and international agencies 26 7

52 OUTLINE EU monitoring system for residues Role of EFSA Role of EFSA Standing Committee on the use of Public Health data in FSIS Food Safety programs Jordi Serratosa PhD EFSA liaison officer at the FDA, Sept 2011, NAS, Washington DC Introduction - how important are residues in EU? Legislative overview in EU Veterinary Medicines Contaminants Pesticides Role of EFSA Reports on residues Main results and trends Current challenges Final remarks EUROBAROMETER: EU consumer concerns on food Chemical products, pesticides and other toxic substances are the major concerns Risk perception: residues Country differences Top concerns in Member States Pesticide residues: GREECE, LITHUANIA, ITALY, LUXEMBOURG, BULGARIA, HUNGARY, FRANCE, MALTA, SLOVENIA, GERMANY, BELGIUM, AUSTRIA Antibiotics residues in meat: CYPRUS, THE NETHERLANDS Pollutants like mercury: FRANCE Quality and freshness of food: LATVIA, LITHUANIA, PORTUGAL, SPAIN, DENMARK, MALTA, ESTONIA, IRELAND The welfare of farmed animals: SWEDEN, UNITED KINGDOM, FINLAND Additives in food and drinks: POLAND, ROMANIA GMOs: AUSTRIA Food poisoning from bacteria: BULGARIA, CZECH REPUBLIC, SLOVAKIA Source: 2010 Eurobarometer on Food-related Risks QF3: Could you tell me in your own words, what are all the things that come to your mind when thinking about possible problems or risks associated with food and eating? QF4: Please tell me to what extent you are worried or not about the following issues. 1

53 Overview of U.S. Federal organizations & EU/ EFSA on food residues The EU Food Safety regulatory framework U.S. EFSA Risk Assessment Risk management DG SANCO FDA/CFSAN Food Allergies, Food toxicology and microbiology FDA/CVM Feed additives, Vet. Medicines USDA/FSIS Microbiological i l risks in meat, EPA Pesticides, Env. Toxicology USDA/APHIS Plant Health and Animal Health and welfare USDA/ARS CDC and NIH/ NTP/NIEHS FDA/ ORA USDA /FSIS Research & data on Nutrition (exposure) Food borne diseases and Toxicology (AMR) Control their respective types of foods as legally competent Legislative proposals to EU member states, European Council and EU parliament. Stakeholder meetings & impact assessment Database coordination with Member States Epidemiology EU Member States + FVO (SANCO) auditing EU and Third countries Official controls (FVO) 882/2004/EC 854/2004/EC Hygiene Regulation HACCP 852/2004/EC 853/2004/EC Hygiene Package 2073/ / / /2006 Feed Additives 1831/2003/EC 429/2008/EC Plant Health 2000/29 575/2006/EC Contaminants 1881/2006/EC Residues -96/22;96/23;2377/90 Pesticides 396/2005/EC (91/414) EU Food legislation EFSA and RASFF Regulation 178/2002 Animal Health and Welfare F. Additives 1333/2008 Reevaluation of Food additives 257/2010 Food contact materials 1935/2004/EC Enzymes 1332/2008 Flavourings 1334/2008 Novel Food 258/97/EC Labelling;2000/13/EC GMO Nutrition Lab. 90/ /2003 Health Claims 1924/2006 Legislative overview on residues in EU Role of EFSA in residues Directive 91/414/EC: pesticides Directive 96/22/EC: prohibition of substances Dir. 96/23/EC: monitoring of substances & residues Reg.(EEC) No 2377/90: MRLs vet. Med. (4-Annex) Regulation (EC) No 178/2002, GFL Reg. (EC) No 882/2004: official controls Reg. (EC) No 1881/2006: MRL contaminants in foodstuffs Reg. (EC) No 396/2005: MRLs for pesticides Reg.(EC) No 37/2010 MRL for vet. med. (1 Annex) Com Decision No 2002/675 on MRPL(Detection limits) Data collected from Member States under Directive 96/23/EC and Data stored in DG SANCO s residue application, coordination of data collection Regulation EC 178/2002, article 31 of the European Commission; Annual report on the results of residue monitoring in live animals and animal products (Directive 96/23/EC) (EFSA-Q ) Results published by European Food Safety Authority (EFSA) during 2009 and every year From the 2006 EFSA/ECDC annual monitoring report on antimicrobial resistance Residue Application SANCO EFSA 8 2

54 Production and number of targeted samples over : EU overall Poultry Animal category Year Production (animals) Targeted samples % Animals tested (a) Minimum 96/23/EC Bovines 2006 (EU 27) (EU 27) (EU 27) Pigs 2006 (EU 27) (EU 27) (EU 27) Sheep/Goats 2006 (EU 27) '000 tonnes Samples/20 00 t 2007 (EU 27) (EU 27) Horses 2006 (EU 27) (EU 27) Not specified FR UK ES DE IT PL NL HU BE RO PT CZ GR DK IE SK SE AT FI BG SI LT LV CY EE MT LU (EU 27) (a): reported to the production of the previous year Non-compliant targeted samples Antibacterials Total 0.32 A 0.18 A % A A A A A B 0.39 Compliant B B B2a % B2b 1.00 B2c 0.02 B2d 0.00 B2e 0.11 B2f 0.21 B B3a 0.19 B3b 0.04 B3c 2.58 B3d 0.22 B3e 1.65 B3f 0.05 Honey Farmed game Rabbit meat targeted samples were analysed for antibacterials 332 (0.21 %) were non-compliant Eggs Milk Aquaculture Poultry Horses Sheep/goats Pigs Bovines Number of samples analysed Honey Farmed game Rabbit meat Eggs Milk Aquaculture Poultry Horses Sheep/goats Pigs Bovines % Non-compliant samples

55 Distribution (targeted sampling EFSA recommendations More detailed data on matrix should be reported (individual results for each sample) 2. Pesticides residues data cannot be aggregate 3. Non compliant samples should be better documented (reason for violation) 4. Corticoesteroids should be included either as -A3 banned- or B2f -with MRL) 5. Results of inhibitor tests are not part of residue plan, but transmitted separately. 13 Scientific basis for policy-driven legislation Surveillance/monitoring : improve trend watching as to enable following-up of trends science-based, informed, prioritized risk managing decisions MSs, COM, EFSA EFSA COM Virtuous circle MSs 15 Current challenges Lack of consistency Dir. 96/23 EC Reg (882/2004 Ø Lack of flexibility not permitting risk based allocation and changes of controls (fixed minimum frequencies) Ø Burdensome annual approval of national monitoring plans Overlaps resulting from implementation of different legislation Ø Contaminants legislation (Regulations (EC) No 315/93 and No 1881/2006) & Pesticides legislation (Regulation (EC) No 396/2005): Ø Specific legislation on contaminants (consumer exposure and no minimum sampling) Ø Pesticides in food of animal origin with coordinated multianunual EU and annual national control programme Enforcement Ø Dir 96/23 EC very precise and lack of flexibility Ø Reg 882/2004 More flexible rationalised approach (case by case) 4

56 EMA report: EU trends in Vet AM sales Vet. Med. Sales in 2009 (9 EU countries) u/ema/index 15 September 2011 Some factors of the equation: SPS Agreement Art. 5.1 : Risk Assessment Members shall ensure that their SPS measures are based on an assessment, as appropriate, of the risks to human, animal or plant life or health, taking into account risk assessment techniques developed by the relevant international organizations. 20 5

57 Risk Assessment: Define the pathways Hazard assessment Timeline for response Establish risk profile Establish risk pathways Determine resources Build model Write model Discuss Results Address additional requests Generate Report Decide on type of RA quantitativ e qualitative Decide whether to proceed with QRA Collect & evaluate data Analyze the data Conduct a qualitative RA FOOD PRODUCTION CONTINUUM CONCEPT Production & primary processing level (abattoir, dairy) Measures relating to animal health + food safety ENSV = for any events that can have an impact on the subsequent ent safety of food products Production conditions & quality of products during and more especially after the primary processing stage. FS best assured by an integrated, multidisciplinary approach OIE CAC 21 Categories of housing systems World pig population densities ( FAO, maps)

58 Pig husbandry systems: Fattening and Breeding Food intake Animal products evolution - Final Remarks Questions??? For risk based approach Drugs used/species (rotation of drugs) Therapeutic treatments/ preventive treatments: Mode of use Environmental impact and public health impact of drugs Consumption data Base (exposure) Trends in consumption Good Agricultural & Veterinary practices (husbandry &Withdrawal) Animal density /areas/ husbandry systems & techno pathies Structure of the sector (integrated, medium size, small) Analytical capacities / harmonization Targeting sampling to optimize cost/public Health Risk/benefit Epidemiology: seasonal trends & Emerging Risks For risk management Socio economic impact: Significant amount of info. available (cf. Residue Database) but lack of data on costs Enforcement capacities Coordination with all stakeholders worldwide 28 7