REPORT OF the COMMITTEE ON GOVERNMENT RELATIONS - …



REPORT OF the COMMITTEE ON GOVERNMENT RELATIONSChair: Bruce King, UTThe Committee on Government Relations met on February 25-26, 2013 in Washington, D.C., in conjunction with the American Association of Veterinary Laboratory Diagnosticians. There were 33 participants on behalf of the two organizations. The Committee convened at the office of the American Veterinary Medical Association on Tuesday, February 25. A summary of the meetings and discussion items is as follows.American Veterinary Medical Association (AVMA) Dr. Mark Lutschaunig, Director of AVMA Governmental Relations Division in DC, introduced the AVMA and Dr. Ron DeHaven, Executive Director of AVMA who joined the meeting via two-way video conferencing. AVMA also included Ms. Gina Luke, Dr. Whitney Miller and Dr. Ashley Morgan.Dr. DeHaven illustrated the current three main areas of involvement of AVMA relevant to USAHA’s Food Animal perspective and AAVLD’s veterinary diagnostics.Building practice and careerPromoting and protecting the professionKeeping veterinarians in all areas and disciplines connectedDr. DeHaven also indicated plans to review and if necessary revise existing AVMA governance structure: currently the Executive Board is composed of 15 members; there are 30 committees and councils, with some potentially ‘superfluous’ redundancies; the 136-member House of Delegates includes 68 organizations; and the organization is staffed by 143 employees, with potential for more efficient use of volunteers. A Taskforce is evaluating accreditation of foreign colleges (currently 13 accredited in mostly English speaking countries) – two sides of the same coin are the solid reputation of US accreditation standards, vs. the concern voice of flooding of the US veterinary job market by graduates from foreign schools.AVMA responded to early February article in New York Times on veterinary new graduates school debt.Mark Lutschaunig provided two hand-outs: the listing of staff members and their areas of responsibilities, and two, AVMA’s priorities in front of the 113th Congress. A comment illustrated a concern with ‘turn-over’ in Congress and the problem of losing champions for veterinary professional issues. Response: AVMA works in a bi-partisan mode and therefore has good relationships with Congress. There also are currently 2 veterinarians in the House, and the profession is well respected.Other key points included: Ms Luke discussed turn-over on congressional ag committees; tax exemption for Loan Repayment Program Enhancement Act, AVMA request for Level funding at $4.7M, handed out information on 175 awards to 555 applicants for total awards of $ 17M. Dr. Miller presented AVMA position on Animal Fighting Spectator Prohibition Act (support), Hose Transportation Safety Act (support), Horse Slaughter (oppose), Horse Protection Act Amendments (support), Egg Products Inspection Act Amendments of 2012 (not set). She responded to a question on how AVMA develops positions – bills provided to committees with oversight or impacted by bill, committees send recommendation to legislative advisory committee to Executive Board, after intro of bill in congress AVMA provides either ‘passive or active pursuit of defeat,’ ‘no action,’ or ‘passive or active pursuit of passage.’ Dr. Morgan presented on Animal Drug User Fee Act (ADUFA), with conditional support of AVMA.Association of American Veterinary Medical Colleges (AAVMC)Executive Director Andy MacCabe introduced the new director of governmental relations, Kevin Cain, who explained some of the current opportunities and challenges. The AAVMC agenda is closely aligned with the AVMA agenda, whose executive leaderships work closely together; Idea of ‘creation’ of veterinary medicine caucus, with 2 current House members being veterinarians, plus adding members from districts with veterinary ics of presentation and discussion were educational financial burden to veterinary students, the opportunities associated with the loan repayment program; need for financial literacy of students, for whom burden of financial commitment has changed from the state to the students; recruitment of a more diverse student body – establishment of a national strategic recruiting plan (student body currently 80% female, 90% Caucasian, 94% suburban, with 94% of seats managed by AAVMC allocation; no change in enrollment in 2 decades, from 1981-2000 (~2300 seats in colleges), since 2001 increase to ~ 3000 seats in US schools; 3-4 new private schools to come into operation in the next few years; initiatives regarding improvement of day 1 readiness of graduates, NAVMEC, regional resource sharing between colleges to create Centers of ‘Excellence?’ among 28 US AAVMC member colleges. Animal Ag CoalitionAAC is chaired by Damon Wells, National Turkey Federation and Gina Luke, AVMA. AAC shared its vision and planning moving forward as a coalition, looking at different opportunities to continue to be a successful voice for animal ag and the best means for hosting meetings and addressing issues. AAC has recently spent most of its focus on Farm Bill passage and appropriations for agriculture programs.Agriculture Research Service Dr. Cyril Gay presented to the Committee on the following key topics:-?????? 150 year anniversary of USDA celebrated in 2012. USDA signed into law by Abraham Lincoln in 1862. In 1862 50% of population rural, in 2012 only 2% of population rural. -?????? 15% of ARS budget is for animal (85% for plant).?-?????? USDA-ARS organized with OIE a symposium of antibiotic usage in animals in 2012. Effort to start bringing focus on development of new tools for animal agriculture and reduce reliance on antibioticso?? Need to integrate nutrition and disease research to enhance synergies and understand antibiotic usage (Highlights of symposium). The current gap in knowledge about alternatives to antibiotics being filled by feed companies. Thus, private industry is getting a lot of products to animal owners without knowledge of how to use the product or how the product works. o?? Clearly need to produce new products for alternatives to antibiotics but also need to support basic research to investigate mechanism of action and optimal utilization.·?????? Budget Requestso?? ARS will not likely have to implement furloughs, which is not compatible with developing new scientists.·?????? Key Research initiativeso?? Biodefense Research Program§? Support NAHLN and other programs to respond to catastrophic disease introduction. §? National Veterinary Stockpile (HSPD-9) requires stockpile be ready in disease outbreak. §? Improvement of countermeasure or development of new counter measures§? Gaps identified through ARS sponsored workshops. Examples include FMD and CSF. In 2013 will host two workshops. One at FADDL (April 2013) on African Swine Fever. Second on High Path Avian Influenza (March 2013) sponsored by U. Georgia. Both will have post workshop report to APHIS and NAHLN. Third workshop (May 14-16) on Orbiviruses (first to address endemic USA disease versus foreign animal disease). Dr. Gay then reviewed responses on 2012 USAHA Resolutions.o?? 8: Support for research on mycobacterial diseases in animalso?? 14: Research on Seneca Valley Viruso?? 15: Vaccine for various strains of EHD16: National review of research needs for bluetongue and related orbivirusesARS Will be workshop identifying gap analysis in May 2013. ·Dr. Gay then addressed questions from the Committee, as outlined below:Is orbivirus workshop in response to USAHA resolution? Yes.Is vaccine development for brucella and tuberculosis priority? Yes ·?????? Current programs in place and funded at NADC on brucellosis and TB (led by Ray Waters and Mitch Palmer). o??What is ARS response to Seneca Valley virus (USAHA resolution)?§? No appropriations from Congress for Seneca Valley virus. After USAHA, ARS leadership discussed resolution. Decided to have Dr. Marcus Kerhli take lead at NADC. Obtaining samples from Hawaii for study (Dr. William Willer). Will inoculate pigs to study pathogenesis and basic virology.§? Funding for new or emerging disease currently through NBAF and FADDL. New program on ASF within ARS ongoing without additional funding. Example of expanding on 5 year research cycle only to include ongoing responses to stakeholder needs (such as USAHA resolutions). o?? Can ARS do a gap analysis on FMD vaccine development and use?§? Current ARS research focused on vaccination to live. That is, vaccine development not only for disease prevention but also disease control (counter measure tool). §? Gap analysis of FMD vaccines is primary role of CEAH (APHIS). ARS is trying to generate information for CEAH to use in their deliberations. Food and Drug Administration – Center for Veterinary Medicine (FDA-CVM)The Committee next met with FDA-CVM, including Dr. Bernadette Dunham, Dr. Renate Reimschuessel; Dr. Bill Flynn and Dr. David White. A summary of the discussion is as followsDr. Bernadette Dunham, Director of CVM (Center for Veterinary Medicine) spoke about Budget.CVM is currently operating on a continuing resolution (CR) congressional action which keeps funding at the previous fiscal year level. This is a total budget of $109 million, $23 million of this is from user fees.Budget sequestration on March 1 is probable, meaning FDA will tighten further, but Dr. Dunham does not foresee any staff furloughs this year.Budget sequestration beyond 2013 would be a bigger problem unless FDA was allowed flexibility to meet budget cuts up to 10%. Higher cuts would also be a problem.FSMA (the Food Safety Modernization Act) should mean more dollars for both CVM and CFSAN (Center for Food Safety and Nutrition). FDA collects user fees from approving animal drugs and generic drugs. There is a hearing on Capitol Hill on the reauthorization of this authority February 27. Dr. Dunham will testify.FDA will continue to interact with constituents, but must conserve funding. Tightening the budget means less travel, more meetings via phone and video, and district office staff may be attending some meetings rather than headquarters staff.Dr. Renate Reimschuessel spoke about the Vet-LIRN (Veterinary Laboratory Investigation and Response Network).Vet-LIRN has grown from an idea in 2010 to a network of 32 laboratories today.Vet-LIRN has awarded 11 cooperative agreements to study salmonella in pets.Vet-LIRN collaborated with 6 laboratories to test a number of animal feed products for various contaminants.Vet-LIRN collaborated with 3 laboratories to optimize methods and test pig tissues for triazine contaminants.Vet-LIRN will contract for a feed survey to identify and prioritize issues.Vet-LIRN conducted investigations and case evaluations, including pet jerky treats.Budget will be an issue in 2013, and grants will be fewer-possibly 3 to 5 rather than 8 to 11.Dr. Bill Flynn briefed the group on CVM antimicrobial strategies, concerns about resistance.A 2010 policy statement began the phasing in of more veterinary oversight and the phasing out of using antimicrobials for growth promotion in livestock.Regulation of animal antimicrobials is impacted by the medical importance of each.Some antimicrobials used for growth promotion may have therapeutic uses added to the approvals.There is a draft guidance out for comment to the pharmaceutical industry on implementation of the above points.Another document is being developed on changing OTC (over-the-counter) products to prescription use. It is recognized that this will involve revamping specific rules related to the VFD (veterinary feed directive) so this change is not onerous. Changes would be implemented in 2016.FDA is collecting data on the use of veterinary drugs—sales and distribution data are not necessarily an accurate description of volumes used.There was discussion of the FDA sampling survey of milk, tissue residues, and whether the two are directly related. There is also concern about how the data will be released and used.Consumer activist groups have filed lawsuits trying to pressure FDA to withdraw approvals for some of the antimicrobials used in livestock.The group discussed the need for better public understanding of these issues and risk (or lack of) involved.Dr. David White, FDA’s Acting Chief Science Officer and Research Director, discussed focusing the research investments of the agency.Between CVM and CFSAN, the agency has 180 scientists. There are efforts currently to prioritize their work and to impact the agency mission (not just publish papers).A high priority will be to validate FDA’s detection methods, particularly since FSMA will allow third parties to use the same methods.FDA is undertaking a major effort to map 100,000 bacterial genomes, geared toward food borne pathogens and animal health targets.The antibiotic development pipeline is almost dry; possibly FDA research on genomes can help. FDA is doing an inventory of all food safety research in the various agencies of the U.S. government (DHS, FDA, CDC, USDA, etc.) with the goal of better coordination and less duplication (also communicating with Canadian government counterparts).The discussion concluded with NARMS (National Antimicrobial Resistance Monitoring System), which has been and ARS (USDA Agricultural Research Service) program. FDA recognizes the value of cooperating with USDA on this and is looking at ways to enhance it.Department of Homeland Security (DHS), Office of Health AffairsDr. Jamie Johnson and Dr. Doug Meckes were welcomed next by the Committee.Dr. Johnson provided and update on the National Bio and Agro Defense Facility (NBAF) and plum Island. DHS received the “green light” to proceed with construction of the utility plant at the NBAF site in Manhattan, KS. The contract for this work has been awarded. Estimated cost for this portion of the construction is $40M. The utility plant construction is considered the middle phase of the construction project. The third phase is the construction of the laboratory proper. DHS is hoping that the budget, anticipated to passed in March, will include full funding for the construction of the NBAF, but there are real challenges due to the tight economic climate, and the effort to cut federal spending.Both the DHS Administration and the people in important positions in Kansas remain committed to seeing this project through. DHS Secretary is supportive. She is optimistic that some money will be allocated in FY ’14 budget. Ideally DHS would get like to have it all allocated because that makes construction cheaper in the long run that way. DHS has not stopped working on other important FAD tools. They are making good progress with FMD vaccines at Plum Island while they work to secure the new NBAF facility. The NBAF facility will be a large building (>600 sq feet). This will take about five years to construct, followed by another 1.5 to 2 years to “commission” the building so that everything is accredited. This means that the current facility on Plum needs to stay operational for another 7-9 years. DHS has invested > $100M in PIADC to keep it functioning. All things considered this is a challenging time to build a new building in the face of current budget challenges. Updated figures for completion of NBAF = $1.2B. $200M has been appropriated to date. KS has provided $150 M leaving $900M still to be appropriated. In response to questions about the decision to build a new laboratory on the US mainland verses refurbishing the existing lab at Plum Island Jamie pointed out the the United Kingdom elected to tear down their lab located in Pirbright and building a new lab because retrofitting old labs is very expensive. Additionally, the cost of construction in NY is high. Add to that the added expense of working on an island, and the feeling is that taxpayer will get much more for his money building a new laboratory on the mainland. Operational expense on a per sq foot basis in the new laboratory will be cheaper than current operating expenses are at Plum Island due to modernizations. Labor will be $ 5-10M cheaper per year in KS than in NY. There are currently 275 employees at Plum Island. It is anticipated that in the new NBAF there will be 350-375.There have been many opportunities for input during planning phase of NBAF. This includes two committees commissioned by the National Academy of Sciences. One of these groups evaluated three options for NBAF: - No Change from the current plan- NBAF light (a similar, but smaller, laboratory option- Stay on Plum IslandThis group found that a new laboratory is needed, that most of the savings of downsizing the current plan would be eaten up in the redesign process. They felt that the US needs to replace the aging facility at Plum Island, so the summary was basically to continue with the current plan.One new thing to come from all of the input in the laboratory design is the inclusion of a bio-development module (BDM). The BDM will helps expedite experimental vaccine development. DHS is going to hold a workshop in Kansas City to hear what the industry thinks about potential uses for the BDM. Can it be leased out to industry, etc. Dr. Meckes provided an update on the Office of Health Affairs.Doug has worked hard keep the importance of the food and agriculture sector before management of DHS. The Secretary asked for an FMD table top to include broad sections of DHS and others. This tabletop stressed importance of ag, and provided some numbers which capture the importance of agriculture to the US economy.bh Quoted from Dermot Hayes study to emphasize importance of ag in economy.HSPD 9 - DHS has experienced variable success with the implementation of HSPD 9. The Health Affairs group has been charged with reviewing the status of HSPD9 implementation. A review has been written and is being circulated within DHS. There is some concern that the ag sector may not have enough visibility in this report. There have been lots of successes that should be included, and may be included in an edited version of the report. This review may be available in 6-9 months (best case scenario). ICLN – lab networks - Matt Coats – Office of University Programs (by phone).Matt works for the Science &Technology (S&T) Directorate within DHS. They partner extensively with USDA and FDA. One of their main goals is to try to harness the knowledge and capabilities in the universities for the Feds.He spoke primarily about the ag center: There are two centers of excellence funded by DHS which share the same mission. One at TX A&M and the other at K-State. This group is called the Zoonotic and Animal Disease Defense Center. It is scheduled to go for six years. They are currently half way through (3 years gone and 3 to go). This program looks at the strategic position of the research portfolio of DHS funded programs for FADs and zoonotic diseases – with a focus on 3 main areas:- Bio-theme: Novel vaccine platforms (Rift Valley fever, African swine fever, and classical swine fever) -Detections themes: Focuses on corresponding assays needed by first responders for the diseases identified in the Bio-theme area. This group has a strong relationship with the Chem-Bio branch of S&T which is overseen by Michelle Colby. - Information anlyisis – how do you link the good work that USDA and DHS do with the industry. This group considers the importance of maintaining business continuity as a part of disease control. Some pilots are underway which are mostly IT-centric. This area focuses on partnerships with industry and producers. Education and training piece – This group also oversees formal education programs and generalized outreach programs which leverage state extensions and adult ed programs. The National Center for Food Protection and Defense (NCFDD) at the University of MN has a unique relationship with the other centers. It conducts research in 3 areas: - Agent behavior and threats in food- Event modeling, horizon scanning, systems strategy – looking at risk. Chem Bio Center - Michelle Colby – Ag Defense Branch Chief in S&TAll three of the people presenting today work together – Jamie, Matt, Michele. They have strong interrelationships with USDA and the Centers of Excellence, allowing the programs to be closely aligned. This group is working on several projects. Several of which are listed below:- Vaccines projects:1) FMD vaccines – this is the longest running project. In the near term they are wrapping up transitioning some molecular-based vaccines for FMD to the private sector. In the mid-term they are working on the characterization of off-the-shelf vaccines for FMD with the goal of being able to supplement the number of doses which are available in the North American FMD Vaccine Bank in the event of a large FMD outbreak. TABBY – transboundary ????? They are evaluating some FMD vaccines being made by Biogenesis, Inc. in Argentina. They are also exploring other foreign manufacturers of FMD vaccine to meet this need.2) Marked molecular vaccines – They are working on vaccines which allow for the differentiation of vaccinated and infected animals. A vaccine for one serotype of FMD is licensed through a private-public partnership. This was started in USDA & DHS, and completed by a private company. This is currently in a field safety study. The plan is to continue to pursue this platform for other serotypes of FMD; and to continue to partner with large vaccine companies with the goal of having 18 vaccines through pipeline by 2018.3) DHS is also investing in other vaccine platforms for other FADS: CSF, RVF ASF, Nipah (Hendra vaccine protect against Nipah?). 4) DHS has several contracts with small companies who will take a research vaccine and turn it into a pre manufacture seed vaccine that can be used for further studies required for licensure. - Diagnostics projects: 1) Diagnostics which support Differentiating Infected from Vaccinated Animals (DIVA) vaccines2) Ag screening tools for the rapid detection of disease. They are working with the FAZD center (TX). Focusing on the use of PCR for FMDv in bulk milk tank samples.3) Pen-side testing for use during an outbreak.4) Evaluating oral fluids in swine for fad testing for surveillance or post event surveillance. 5) Investing in some other technologies – infrared thermographry to identify sick animals from a distance. 6) Also Looking at decontamination strategies, disposal strategies, and depopulation strategies for use during and FAD outbreak.- FAD modeling1) They are building a national scale model which estimates the need and supply of workforce and supplies, etc. for responding in the case of an outbreak. There was a discussion on vaccine from off the shelf for use in the USA. The last discussion item included certified training courses for agriculture, and delivery and effectiveness of making these available. Dr. Meckes sought input from the group.The Committee then adjourned for the day, to reconvene the next morning at the USDA Whitten Building.USDA-APHISThe first meeting for Wednesday, February 26 was with USDA-APHIS, Veterinary Services. Participants included Drs. John Clifford, Jon Zack, John Picanso, Neil Hammerschmidt, LeeAnn Thomas, Beth Lautner, and Sharon Fisher. Dr. Clifford first addressed the pending sequestration and expectations. VS has lost approximately 200 positions due to recent budget adjustments, including several not being filled or re-filled because of budgetary concerns. Actions have been taken since the beginning of the FY to adjust spending in anticipation of this. Furloughs are not expected, but there will likely be reductions in services, especially in the area of 2013-2014 cooperative agreements.2014 budget: not yet released by President Obama. 2013 budget contained ~$5 million for animal disease programs. VS will not receive this under the continuing resolution (CR) now in place.John Picanso provided an update on two modernization initiatives:Surveillance Collaboration System (SCS; re-branded Core One product)Emergency Management Response System (EMRS) The previous platforms, GDB and previous version EMRS, were built on Lotus Notes platform which is being retired. Data migration from GDB to SCS has been completed in two years (approx. 2 billion rows of information). COGNOS, a reporting and potentially an analytical tool, is available to SCS users and is coupled in all SCS installs.The NAHLN data system has been re-named to the Laboratory Messaging Service (LMS). There is a target date of 26 March 2013 to start receiving the Cornell laboratory information under a pilot project. The intent is to make LMS the conduit for any lab info into SCS and EMRS.Data Standards for data elements and data exchange are being developed within VS through a recently initiated subcommittee of lab personnel, industry, state animal health officials, and others. A Federal Register posting of draft data standards is available on the VS website. These data conventions are now available for use.Jon Zack presented the latest developments in Foot and Mouth disease (FMD) and emergency preparedness. FMD – the overall policy and approach are the same as always, starting with the priority of containment and control on a single premises. The larger approach picture is a much more complex one of expanded options, contingencies, and flexibility including the use of vaccine and vaccination scenarios, movement controls, and animal identification. A state animal health official working group may be convened to identify and discuss from a project management perspective similar to that used to develop the Animal Disease Traceability model.The US, Canada, New Zealand, and Australia developed and submitted to the OIE Scientific Committee a paper on nations using high potency FMD vaccine maintaining FMD Free status – not Free With Vaccination status. OIE internal consideration is expected to require a couple years. This position will need our support (USAHA, SAHOs) when/if it is favorably received within OIE.Another OIE issue is that of the use of new technologies in disease management. A survey of member countries is being conducted on how new technologies such as diagnostic imaging, GPS, and others are being used in disease surveillance and management. The OIE will consider how to best incorporate these tools and what standards should be established for acceptance of programs that use these tools for disease status classifications.A final point on consumer acceptance of food products from FMD vaccinated animals was discussed. Communications professionals will need to be engaged well ahead of any outbreak for assistance regarding this issue and others associated with FMD management.Animal Disease Traceability was next addressed by Neil Hammerschmidt. ID tags and devices which are not collected with a sample (ie granuloma submission) will be given to APHIS VS. VS is working on a plan to ‘retire’ those tags by entering all manmade ID collected from slaughter into a searchable database.A recent VS study indicated that more ID is collected at slaughter than current opinion would support. The results of this study will be available soon.The ADT regulation requires that the establishment collect ID and maintain throughout slaughterVS is working on an MOU with FSIS so that FSIS can establish clear directives to plants. This will also give better direction to VS employees for uniform enforcement of the regulations regarding:Collection of ID at slaughter – there will be a checklist for VS staffReviewing protocol (HACCP-type) to ensure complianceWhat to do with tags after we have them??There are two Pilot projects dealing with retired numbers:Tag retirement center (WI)The start-up plan involves 2 plants which will send tags to the center where they will be entered into a database with an event code. This includes production tags as well as official ID.Outreach and Training to DVMsVS is planning to add a module to the accreditation site. This will take several months to develop.ADT Roadmaps will support AVICs in providing training to DVMsHandouts, CDs, PowerpointsClifford, along with Lee Ann Thomas led discussion on identification of Mexican origin feeder cattle.Mexican ID – Mexico using SINIIGA tags, which are tracked by an industry coordinated computer system.to synchronize EID and other tagsMexican officials are pushing to use SINIIGA tags in place of blue ear tagsVS inspectors review blue tags at importChallenges at port re-screening re: SINIIGA tagsIf we had EID systems, electronic certification would workUSDA does not currently have electronic capabilitiesLong term goal is that VS intends to have an electronic systemDr. Bob Meyer (WY) asked if VS might consider recognizing SINIIGA EID in roping cattle, recognizing that metal tags are often removed (illegally) from roping cattle due to complications with their intended use. Dr. Clifford indicated that VS would look into this possibility.There is concern among all involved for illegal removal of tags.Dr. Jere Dick noted that Dr. TJ Meyer is working on VS’ ability to write administrative tickets.Would relieve OJC attorneys and allow them to focus on “upper end” problemsIn addition, states could / should have administrative authority, under state regulations, to deal with these issues as well.A question was asked about Electronic CVIs – Explore use of eCVIs for International movementDr. Clifford noted that the proposed VS Service Center development is based upon the use of electronic CVIs for international movement.Discussion continued on some of the brucellosis vaccination and research projects:Gonacon for the use in bison, looking to test efficacy and effectiveness of rendering brucella infection ineffective in bison.RB51 use in elk and bison - vaccination response using RB51 in bison and elkTB vaccination:No activities relating to TB vaccination of cattle in U.S.Some work by ARS on TB vaccination for cervidsTB StatPak & DPP:Just initiated Feb 4th, closely monitoring results.When compare the skin test in the field to a laboratory test, we want to carefully evaluate the field test positives from the new test...we have seen about 10 cases of DPP-positive cervids. Any animals that are DPP positive on the first test or DPP positive on the second test, we will heavily screen them for TB. We will indemnify the animals after the first DPP positive and necropsy. The guidelines do provide for a second DPP test if the first DPP is positive.StatPak is an antibody response test and read visually but a good screening test; still need to evaluate tests against necropsy results.Can it be approved in mule deer? Will be stockpiling some serum to evaluate its possible use for mule deer - initial results don't look promising. Specificity for cervids is 99.4 and sensitivity is 87.1. Would state animal health officials consider it as an official test for unapproved cervid species?? It is hard to validate for other species when have limited samples in those species.Swine brucellosis & pseudorabies:Published new regulations and up for comment. States are considered free for BR and PRV but may have feral swine with those diseases. The concept paper looks at combining swine BR and PRV regulations as the diseases have some of the same risk factors. The new regs will streamline the rules and will move away from state based disease status. Similar to cattle BR and TB regs. State swine health plans should include feral and "transitional" swine. Please look at the concept paper and make comment. Not looking at setting up a separate working group but want stakeholder input through web, webinars, etc. Need stakeholder input!Do the states want a working group to work on these rules? The classification of a state would be similar to other disease programs...they would be consistent, inconsistent, or provisionally consistent. The rules are basically risk based and flexible.A comment was post regarding bovine spongiform encephalopathy (BSE) indicating the possible need to review the present protocol for renderers so that carcasses which are submitted for rabies, are flagged at the render and held until testing for rabies and BSE is completed.The NAHLN Coordinator Position is listed, needs to be a DVM or Microbiologist (as defined by USDA)Dr. Clifford then discussed VS participation for the 2013 USAHA Annual MeetingThe Committee next discussed Cooperative Agreement funding, and the shift to a more umbrella cooperative agreement to increase flexibility for the states. The VS Staff then provided an overview on VS Reorganization:Organized around 4 categories of function:Science and Technology ServicesAdministrative Support Group (Program Support Services)National Import & Export ServicesSurveillance and Response GroupThe Committee next welcomed Dr. Beth Lautner with NAHLN/NVSL, joined by teleconference with Drs. Sarah Tomlinson and Christie Loiacono. Dr. Lautner led the discussion providing the following updates:Dr. Mia (Kim) Torchetti is the new Avian Viruses Section Head in the Diagnostic Virology Laboratory (DVL) at NVSL (Mia.Kim.Torchetti@aphis. and (515) 337-7551.The NAHLN Coordinator position was approved for refilling and has been posted internally and externally, to be open for a minimum of 3 weeks. Outlets include USAJobs, AAVLD, USAHA, and AVMA websites. AAVLD will be represented on the interview panel.A2LA accreditation of NVSL included the Veterinary Laboratory Accreditation Program Requirements, increasing to 62% the percentage of accredited tests offered. For the first time, the scope encompassed proficiency tests (AI/END/FMD/CSF PCR) and reference materials (Brucella and AI AGID materials). Reorganization will allow growth in the number of PTs available.The state/federal relationships forged between NVSL/NAHLN and the State Veterinarians during the SIV A cases in fair goers last summer augmented those between APHIS/ARS and CDC. NVSL’s whole-genome sequencing allowed CDC to compare with human cases and ARS to keep SIV experts in the loop. Voluntary, anonymous surveillance program is evolving this summer to include NAHLN labs PCR subtyping and collection of clinical histories.NVSL and SEPRL evaluated pooling 11 swabs/tube vs 5/tube to decrease costs for AIV surveillance and found no differences in diagnostic sensitivity and specificity. The test is not valid if 11 swabs are used with the small volume of media appropriate for 5 swabs. Logistics still to be worked out before implementing the increased swab count include media volume or pooling from 2 tubes, changing tube size, rack size, centrifuge time, filtration instead of autoclaving. NVSL and AAVLD are coordinating a non-regulatory ring test for PCR-based EHV detection and typing to distinguish neuropathic EHV-1 and to establish performance limits using different platforms with the goal of determining relative sensitivity and specificity. Dr. Tim Baszler has been coordinating the AAVLD labs, and 8 isolates (HV-1, HV-2, HV-5) have been submitted. These will be sequenced by Dr. Udeni Balasuriya at the Gluck Center, and hopefully ready to begin the collaborative study this summer.Three new Scrapie/CWD testing platforms have been approved by NVSL/VS for use in the 21 NAHLN labs performing surveillance to replace the Ventana NexES (being obsoleted). Labs may select from: Biocare Medical’s IntelliPATH FLX?, Leica Microsystem’s BOND MAX, or the Ventana Discovery XT. NVSL-PL will continue to provide SOP, PT, reagent QA and confirmatory testing on each of the platforms.The NAHLN Coordinating Council has reviewed the NAHLN reorganization concept paper (2011) to meet missions of early detection, rapid response, and appropriate recovery from adverse animal health events. The Notice of Availability of a National Animal Health Laboratory Network Reorganization Concept Paper will be published in the Spring 2013 Federal Register for stakeholder comment.The NAHLN IT system has been transformed to a Laboratory Messaging Service (LMS)able to accept HL7 messages from any lab for any disease of interest for NVSL-VS. In March 2013, it will begin to accept messages about SIV and PRV surveillance testing. The LMS group is working with State Animal Laboratory Messaging Services (SALMS) to ensure compatibility and integration.CoreShield secure communication and information sharing mechanisms was used to develop a NAHLN Portal. A module of information on laboratories, their scopes of testing, their funding and their equipment inventories is currently in service. A partial module for registration and tracking proficiency testing is newly released. The next modules planned are for SOP and performance monitoring. The Portal also allows workgroup and webinar collaborations.In 2012, NVSL-FADDL completed an FMD penside negative cohort study (2 NAHLN labs) and an FMD milk PCR interlaboratory comparison (5 NAHLN labs, NVSL-FADDL, & Pirbright). The negative cohort study validating the real-time PCR for FMDV in bulk tank milk samples will be completed in March 2013. Also planned for 2013: a larger FMD penside negative cohort study (FAZD and NVSL-FADDL) to validate a commercial penside assay and an FMD serological negative cohort study (NAHLN labs and NVSL-FADDL).USDA, National Institute for Food and Agriculture NIFAThe Committee welcomed Dr. Meryl Broussard, Dr. Gary Sherman,and Dr. Mark Murano The representatives covered several topics, and related to budgeting and programming updates.Budget – There is a high level of uncertainty continues. Working on FY14 & FY15 budgets with no FY13 budget adopted is a challenge. Currently under a Continuing Resolution with 50 separate line items in budget. Sequester would likely result in 5% cuts to each line item with no flexibility to move between line items for NIFA. While sequester is a concern, the bigger concern is a final appropriations bill for this year. Lack of a final appropriations bill for the full FY has held up the various grant programs.NAHLN – NIFA remains committed to the NAHLN and working in concert with APHIS on NAHLN – both agencies are on the same page.NAHLN – recognize the need for continued improvement in communications on the merits of NAHLN to OMB, the Director of NIFA and others.NIFA expects to maintain the same percentages that currently exists in distributing the budget line item that funds not only the NAHLN but also the plant lab network and EDEN. This would apply to cuts and increases.VMLRP – 107 awards have been made through the program to date. Expectation is for $4.7-4.8M in new funding which would allow for approximately 50 new awards.VMLRP – discussion about the possibility of cross border nominations, state level input in selection and allowing applicants to apply for more than one shortage situation simultaneously covered the advantages of these options but also the reasons why NIFA procedures have not allowed these up to this point. No immediate changes on this front are expected.AFRI – reviewed the grant programs (outlined on handout). $260M currently available in this program.FARAD – currently at its highest funding level ever. Nature of this funding is that it will continue to be an every year battle for funding. Small line items such as FARAD will continue to be at high risk as a target for elimination from people who do not understand the program and are looking for cuts or offsets. FARAD is unique within NIFA as a continuing service program – other programs are time limited research.USDA, Food Safety Inspection ServiceThe Committee next welcomed FSIS representatives Phil Derfler, Dan Englejohn and Patty BennettThey addressed collection of identification at slaughter, particularly on disease traces. FSIS and APHIS are developing an MOU for this process. They are reviewing SOPs on lymph collection vs. cross contamination. There is incentive within plants on collection.The Committee asked if there would be input on the MOU process outside of USDA.Mr. Derfler addressed the FSIS plan in regards to furlough, expecting 5% across the board. Within the FSIS budget, 83% is workforce. Any furloughs would have 30-day notice, and also considerations as the positions are union. The Committee asked about the PHIS system, which is fully implemented domestically, with data coming in. Plants are beginning to use to identify problems. Poultry modernization rule was also addressed, they received more than 100,000 comments on rule. A number of significant issues were identified, including worker safety. The final rule in the review process.Mr. Derfler provided information on the reorganization update, now in phase II. This is part of the strategic plan for 2011-2016, which includes annual performance plan, organizational efficiencies. The final item for discussion included horse slaughter. FSIS has received five inquiries for processing facilities. The Committee then adjourned the meeting. ................
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