Proposed Changes Booklet

Transcription

1 Proposed Changes Booklet to be considered at the: NPIP 42nd Biennial Conference 0 P a g e

2 TABLE OF CONTENTS 9-CFR Proposed Changes Proposal Subpart Subpart Page Subject of Proposal Number Delegates , 146 Combined 3 Amends the approval process for new diagnostic tests , 146 Combined 6 Clarifies participation in the National Poultry Improvement Plan , 146 Combined 7 Amends Authorized Laboratory requirements , 146 Combined 8 Amends Authorized Laboratory requirements E 10 Amends testing requirements for Subpart E Mycoplasma Programs B,6C,6D,6E 13 Amends the definition of Poultry , 146 Combined 14 Clarifies hatchery inspection requirements , 146 Combined 15 Amends Authorized Laboratory requirements D 16 Amends participation requirements for turkeys I 17 Amends AI testing requirements for meat-type breeding waterfowl I 18 Amends participation requirements for meat-type breeding waterfowl Combined 19 Amends inspection requirements for commercial slaughter plants B 21 Clarifies testing requirements for commercial table egg layers , 146 Combined 22 Proposes changes to location of Table of Contents in 9CFR , 146 Combined 23 Eliminates tube agglutination as an approved Mycoplasma test , 146 Combined 24 Recognizes molecular examination as option for Mycoplasma diagnosis , 146 Combined 25 Amends definition of breeding flock , 146 Combined 26 Includes the most recent subparts added to NPIP program for PT testing H 27 Amends Salmonella Monitored certification requirements , 146 Combined 29 Amends Mycoplasma Hemagglutination Inhibition test interpretation B 30 Addition of table-egg layer pullet participants E 31 Addition of testing commercial table-egg producing upland game birds and waterfowl for Avian Influenza 1 P a g e Program Standards Proposed Changes 1. PS Combined 33 Allows use of rt-pcr primers for Salmonella Enteritidis detection 2. PS Combined 35 Amends sanitation procedures for Salmonella and Mycoplasma control 3. PS Combined 37 Amends cleaning and disinfection procedures 4. PS Combined 40 Amends flock sanitation procedures 5. PS Combined 43 Amends Mycoplasma serum plate agglutination procedures 6. PS Combined 44 Clarifies rapid methods for detection of Salmonella 7. PS Combined 45 Amends Mycoplasma serum plate agglutination test interpretation 8. PS Combined 46 Clarifies bacteriological examination procedures 9. PS Combined 47 Amends procedures and recommendations for Mycoplasma detection, diagnosis, etc. 10. PS Combined 61 Addition of new diagnostic tests for Salmonella and Mycoplasma

3 Present provisions of the National Poultry Improvement Plan are contained in the U.S. Department of Agriculture publication, "National Poultry Improvement Plan and Auxiliary Provisions," and in Title 9 CFR parts 145, 146, 147, 56 and the Program Standards. The detailed procedure for making changes in the Plan is described in the auxiliary provisions, sections through Copies of the "National Poultry Improvement Plan and Auxiliary Provisions" are available from each Official State Agency or from the National Poultry Improvement Plan staff, Animal and Plant Health Inspection Service, Veterinary Services, Suite 101, 1506 Klondike Road, Conyers, Georgia or at the NPIP web site: Proposed changes and supporting statements in this publication were submitted as provided in section They are compiled in this publication for consideration at the 2014 National Plan Conference. This publication is distributed well in advance of the conference so that participants and other interested persons may review the proposed changes and inform conference delegates of their wishes regarding the proposals. Some proposed changes have a line drawn through a portion of the words while other portions are underlined. The line through the words indicates that they are part of the present provision but would be deleted if the proposal were adopted. The underscored words are the proposed additions to that provision. Each State is entitled to one official delegate for each of the subparts, B, C, D, E, F, G, H and I of part 145 and B, C, D and E of part 146. Each delegate will act on proposals affecting the provisions of the program which he represents. For reference purposes, delegates are designated as follows: subpart B delegates - egg-type chickens subpart C delegates - meat-type chickens subpart D delegates - turkeys subpart E delegates - waterfowl, exhibition poultry, and game birds subpart F delegates - ostrich, emu, rhea, and cassowary subpart G delegates- primary egg-type chickens subpart H delegates- primary meat-type chickens subpart I delegates- meat-type waterfowl subpart 6B delegates- commercial table-egg layers subpart 6C delegates- commercial meat-type chickens subpart 6D delegates- commercial meat-type turkeys subpart 6E delegates-waterfowl, upland gamebirds This compilation of proposed changes includes, in the margin adjacent to the section reference for each proposal, the delegate entitled to vote on the proposal. Some of the changes proposed apply equally to all participants, in which case, conference action will be determined by the combined vote of all delegates. 2 P a g e

4 Proposal No. 1 Combined Approval of diagnostic test kits not licensed by the Service. 1. Diagnostic test kits that are not licensed by the Service (e.g., bacteriological culturing kits) may be approved through the following procedure: (a) The sensitivity of the kit will be estimated in at least three NPIP authorized laboratories selected by the Service by testing known positive samples, as determined by the official NPIP procedures found in the NPIP Program Standards or through other procedures approved by the Administrator. Real clinical samples for which the presence or absence of the target organism or analyte has been determined by the current NPIP test should be used, not spiked samples or pure cultures. Samples representing a range of analyte concentrations should be used. In some cases it may be necessary to utilize samples from experimentally infected animals. Spiked samples (clinical sample matrix with a known amount of pure culture added), should only be used in the event that no other sample types are available. Pure cultures should never be used. Additionally, labs should be selected for their experience with testing for the target organism or analyte with the current NPIP approved test. If certain conditions or interfering substances are known to affect the performance of the kit, appropriate samples will be included so that the magnitude and significance of the effect(s) can be evaluated. (b) The specificity of the kit will be estimated in at least three NPIP authorized laboratories selected by the Service by testing known negative samples, as determined by tests conducted in accordance with the NPIP Program Standards or other procedures approved by the Administrator in accordance with (d)(1). If certain conditions or interfering substances are known to affect the performance of the kit, appropriate samples will be included so that the magnitude and significance of the effect(s) can be evaluated. (c) The kit will be provided to the cooperating laboratories in its final form and include the instructions for use. The cooperating laboratories must perform the assay exactly as stated in the supplied instructions. Each laboratory must test a panel of at least 25 known positive clinical samples supplied by the manufacturer of the test kit. It is strongly preferred that labs secure samples from routine submissions. In addition, each laboratory will be asked to test at least 50 known negative clinical samples obtained from several sources, to provide a representative sampling of the general population. The identity of the samples must be coded so that the cooperating laboratories are blind to identity and classification. The cooperating laboratories must perform a current NPIP procedure or approved test on the samples alongside the test kit for comparison. Each sample must be provided in duplicate or triplicate, so that error and repeatability data may be generated. Special Considerations Salmonella. It may be difficult to find naturally-contaminated positive samples for serotypespecific assays. The use of spiked samples should be avoided. A last resort should be the use of experimentally produced samples, such as bird inoculation and environmental testing. The importance of naturally-contaminated samples comes from the fact that these are wild 3 P a g e

5 (non-lab adapted) isolates, present in various levels competing with other organisms in the samples and may or may not be sub-lethally injured. Mycoplasma. Finding sufficient field positive mycoplasmas (MG, MS and MM) may be difficult, but it is important to test them. Testing naturally contaminated samples provides for detection of various levels of the target organism within the background flora of the tissue. It may also provide opportunities for testing of various strains, including vaccine strains that may be present. Avian Influenza. Avian influenza samples may not be available and may require experimentally infecting birds. It will be important to select laboratories that are equipped and experienced or authorized for handling AIV. PCR-based testing. The production of DNA from a panel of isolates may be sufficient to evaluate PCR-based tests, although real clinical samples are preferred. The panel of isolates could include target and non-target strains and may also represent different detection levels and mixed cultures. The party submitting the test for approval should have generated the initial validation and verification data (specificity, sensitivity, etc.) with known samples prior to submitting the test for approval. Therefore it would be more meaningful for the 3 testing labs to process field samples or samples which simulate the potential diversity of the organism and the actual sample matrix as closely as possible. The party submitting the test for approval must recommend a specific extraction method to be used with the PCR test. NPIP approved laboratories may use an alternative extraction method if they can show equivalency to the recommended extraction method. (d) Cooperating laboratories will submit to the kit manufacturer all raw data regarding the assay response. Each sample tested will be reported as positive or negative, and the official NPIP procedure used to classify the sample must be submitted in addition to the assay response value. A completed worksheet for diagnostic test evaluation is required to be submitted with the raw data and may be obtained by contacting the NPIP office. Raw data and the completed worksheet for diagnostic test evaluation must be submitted to the NPIP office four months prior to the meeting, which is when approval will be sought. (e) The findings of the cooperating laboratories will be evaluated by the NPIP technical committee, and the technical committee will make a recommendation regarding whether to approve the test kit to the General Conference Committee. If the technical committee recommends approval, the final approval will be granted in accordance with the procedures described in and (f) Diagnostic test kits that are not licensed by the Service (e.g., bacteriological culturing kits) and that have been approved for use in the NPIP in accordance with this section are listed in the NPIP Program Standards: 2. Approved tests modification and removal (a.) The specific data required for modifications of previously approved tests will be taken on a case by case basis by the technical committee. 4 P a g e

6 (b.) If the technical committee determines that only additional field data is needed at the time of submission for a modification of a previously approved test, allow for a conditional approval for 60 days for data collection side-by-side with a current test. The submitting party must provide complete protocol and study design, including criteria for pass/fail to the technical committee. The technical committee must review the data prior to final approval. This would only apply to the specific situation where a modified test needs additional field data with poultry to be approved. (c.) Approved diagnostic tests may be removed from the Plan by submission of a proposed change from a member of the technical committee. The data in support of removing an approved test will be compiled and evaluated by the NPIP technical committee, and the technical committee will make a recommendation regarding whether to remove the test kit to the General Conference Committee. If the technical committee recommends removal, the final decision to remove the test will be granted in accordance with the procedures described in and Reason: Due to confusion regarding the requirements for approval of updates to tests which have been previously approved for the NPIP, a review of the entire approval process was conducted by a subcommittee of the NPIP technical committee. The diagnostic test evaluation worksheet provides a standardized template which will both ensure that all needed data has been prepared and will make review easier for the technical committee by capturing all the data for each test in a uniform manner. It is too difficult to broadly define a minor modification versus a major modification and to determine beforehand what data might be needed if not the full data needed for a new test. Allowing the temporary use of a modified test side by side with the approved versions using field samples (as opposed to the 75 defined validation samples required for new tests) would make it easier for labs to participate in the validation process. As new tests are approved, older less accurate tests should be phased out. Sponsor: Sub-committee of the NPIP Technical Committee 5 P a g e

7 Proposal No. 2 Combined Participation. (a) The National Poultry Improvement Plan is a cooperative Federal-State-Industry mechanism for controlling certain poultry diseases. The Plan consists of a variety of programs intended to prevent and control poultry diseases. The Plan identifies States, flocks, hatcheries, dealers, and slaughter plants that meet certain disease control standards specified in the Plan's various programs. As a result, customers can buy poultry that has tested clean of certain diseases or that has been produced under disease-prevention conditions. Participants maintain records to demonstrate that they adhere to the disease control programs in which they participate. Any person producing or dealing in products may participate in the Plan when he has demonstrated, to the satisfaction of the Official State Agency, that his facilities, personnel, and practices are adequate for carrying out the applicable provisions of the Plan, and has signed an agreement with the Official State Agency to comply with the general and the applicable specific provisions of the Plan and any regulations of the Official State Agency under Affiliated flockowners may participate without signing an agreement with the Official State Agency. (b) Each participant shall comply with the Plan throughout the operating year of the Official State Agency, or until released by such Agency. (c) A participant in any State shall participate with all of his poultry hatching egg supply flocks and hatchery operations within such State. The participant shall report to the Official State Agency on VS Form 9 2 (formerly NPIP Form 3B) or through other appropriate means each breeding flock before the birds reach 24 weeks of age or, in the case of ostriches, emus, rheas, and cassowaries, before the birds reach 20 months of age. This report will include: (1) Name and address of flockowner; (2) Flock location and designation; (3) Type: Primary or Multiplier; (4) Breed, variety, strain, or trade name of stock; (5) Source of males; (6) Source of females; (7) Number of birds in the flock; and (8) Intended classification of flock. (d) To ensure that Plan diseases are not spread, flocks should be qualified for their intended Plan classifications before being moved into breeder production facilities. (e)no person shall be compelled by the Official State Agency to qualify products for any of the other classifications described in as a condition of qualification for the U.S. Pullorum-Typhoid Clean classification. (f) Participation in the Plan shall entitle the participant to use the Plan emblem reproduced below: Reason: A statement of intent and/or purpose is necessary to indicate the actual reason of Plan participation and recordkeeping. Sponsor: Dr. Tony Frazier Alabama Department of Agriculture and Industries 6 P a g e

8 Proposal No. 3 Combined Authorized Laboratories (d) State site visit. The Official State Agency will conduct a site visit and recordkeeping audit annually once every five years.. This will include, but may not be limited to, review of technician training records, check test proficiency, and test results. The information from the site visit and recordkeeping audit will be made available to the NPIP upon request. Reason: The current requirement of (d) requires an annual inspection. In implementation this has proven unnecessary since laboratory procedures and personnel generally do not change that frequently and the need for OSA s to inspect laboratories in other States serving industry members within their own States annually unnecessarily consumes time and travel funds best utilized in other areas of the Plan. In coordination with the requirement of (e) that the Service review authorized laboratories every 3 years, inspection every 5 years by the OSA should ensure adequate performance. For information, the American Association of Veterinary Laboratory Diagnosticians (AAVLD) inspects and certifies laboratories once every five years. Sponsor: Dr. Eric Gonder Butterball, LLC 7 P a g e

9 Proposal No. 4 Combined Authorized laboratories. These minimum requirements are intended to be the basis on which an authorized laboratory of the Plan can be evaluated to ensure that official Plan assays are performed in accordance with the NPIP Program Standards or other procedures approved by the Administrator in accordance with (d)(1) and reported as described in paragraph (f) of this section. A satisfactory evaluation will result in the laboratory being recognized by the NPIP office of the Service as an authorized laboratory qualified to perform the assays provided for in this part. (a) Check-test proficiency. The NPIP will serve as the lead agency for the coordination of available check tests from the National Veterinary Services Laboratories. The authorized laboratory must use a regularly scheduled check test for each assay that they it performs. Proficiency tests should be performed by each technician running the assay within the past 3 years. (b) Trained technicians The testing procedures at the laboratory must be run or overseen by a laboratory technician who has satisfactorily completed the check-test proficiency for that assay. If the assay specific check test is not satisfactorily completed, the laboratory technician must attendedattend and satisfactorily complete Serviceapproved laboratory workshops for Plan-specific diseases. within the past 4 years. (c) Laboratory protocol. Official Plan assays must be performed and reported as described in the NPIP Program Standards or in accordance with other procedures approved by the Administrator in accordance with (d)(1). Assays must be performed using control reagents approved by the Plan or the reagent manufacturer. (d) State site visit. The Official State Agency will conduct a site visit and recordkeeping audit annually. This will include, but may not be limited to, review of technician training records, check test proficiency, and test results. The information from the site visit and recordkeeping audit will be made available to the NPIP upon request. (e) Service review. Authorized laboratories will be reviewed by the Service (NPIP staff) every 3 years. The Service s review may include, but will not necessarily be limited to, checking records, laboratory protocol, check-test proficiency, technician training, and peer review. Alternatively, an authorized laboratory may be accredited by a 3 rd party organization (American Association of Veterinary Diagnosticians (AAVLD), American Association for Laboratory Accreditation ( A2L2), etc.) if it meets NPIP minimum requirements in this section. (f) Reporting. (1) A memorandum of understanding or other means shall be used to establish testing and reporting criteria to the Official State Agency, including criteria that provide for reporting H5 and H7 low pathogenic avian influenza directly to the Service. (2) Salmonella Pullorum and Mycoplasma Plan disease reactors must be reported to the Official State Agency within 48 hours. (g) Verification. Random samples may also be required to be submitted for verification as specified by the Official State Agency. Reason: With financial restraints affecting many laboratories, the cost of sending technical staff for training to meet testing requirements of numerous organizations may be difficult. The successful passage of a well-constructed proficiency test is an ideal measure of a laboratory s potential for producing reliable results. This measures both the technician and the procedure and may negate the need for additional training. Please understand, NPIP needs to continue offering the excellent training they currently provide, not only for technical 8 P a g e

10 training but also to inform participants of new or better procedures. The accreditation of laboratories is also an extremely important issue. Currently, there are a number of different accrediting bodies for different organizations or purposes. Efficiency and cost savings could be significant to both NPIP and the many laboratories if a 3 rd party accrediting organization can be found to meet NPIP s needs. Sponsor: Dr. Bruce Charlton California Animal Health & Food Safety Laboratory - Turlock 9 P a g e

11 Proposal No. 5 E Terminology and classification; flocks and products. (c) U.S. M. Gallisepticum Clean. (1) ) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from M. gallisepticum has been demonstrated under the criteria specified in paragraph (c)(1)(i) or (ii) of this section. (i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. gallisepticum as provided in (b) when more than 4 months of age or upon reaching sexual maturity: Provided, That to retain this classification, a random sample of serum or egg yolk or a targeted bird sample of the choanal palatine cleft / fissure area using appropriate swabs from at least 5 percent of the all the birds in the flock if flock size is less than 30, but at least 30 birds, shall be tested at intervals of not more than 90 days: And provided further, That a sample comprised of less than 5 percent 30 birds may be tested at any one time, with the approval of the Official State Agency and the concurrence of the Service, provided that a total of at least 5 percent of the birds in the flock, but at least 30 birds or all birds in the flock if flock size is less than 30, is tested within each 90-day period; or (ii) It is a multiplier breeding flock which originated as U.S. M. Gallisepticum Clean baby poultry from primary breeding flocks and a random sample comprised of 50 percent of the birds in the flock, with a maximum of 200 birds and a minimum of 30 birds per flock or all birds in the flock if flock is less than 30 birds, has been tested for M. gallisepticum as provided in (b) when more than 4 months of age or upon reaching sexual maturity: Provided, That to retain this classification, the flock shall be subjected to one of the following procedures: (A) At intervals of not more than 90 days, a random sample of serum or egg yolk or a targeted bird sample of the choanal palatine cleft/fissure area using appropriate swabs from at least 2 percent of all the birds in the flock if flock size is less than 30, with a minimum of 30 birds per pen, but at least 30 birds shall be tested; or (B) At intervals of not more than 30 days, a sample of 25 cull baby poultry produced from the flock shall be subjected to laboratory procedures acceptable to the Official State Agency and approved by the Service, for the detection and recovery of M. gallisepticum. (2) A participant handling U.S. M. Gallisepticum Clean products shall keep these products separate from other products in a manner satisfactory to the Official State Agency: Provided, That U.S. M. Gallisepticum Clean baby poultry from primary breeding flocks shall be produced in incubators and hatchers in which only eggs from flocks qualified under paragraph (c)(1)(i) of this section are set. (3) U.S. M. Gallisepticum Clean baby poultry shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter. 10 P a g e

12 Proposal No. 5 continued E Terminology and classification; flocks and products. (d) U.S. M. Synoviae Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from Mycoplasma synoviae has been demonstrated under the criteria specified in paragraph (d)(1)(i) or (d)(1)(ii) of this section. (i) It is a flock in which a minimum of all birds or a sample of at least 300 birds has been tested for M. synoviae as provided in (b) when more than 4 months of age or upon reaching sexual maturity: Provided, That to retain this classification, a random sample of serum or egg yolk or a targeted bird sample of the Choanal palatine cleft / fissure area using appropriate swabs (C.P. swabs) from at least 150 all the birds in the flock if flock size is less than 30, but at least 30 birds, shall be tested at intervals of not more than 90 days: And provided further, That a sample comprised of fewer than 150 less than 30 birds may be tested at any one time with the approval of the Official State Agency and the concurrence of the Service, provided that a minimum of 150 birds total of at least 30 birds, is tested within each 90-day period; or (ii) It is a multiplier breeding flock that originated as U.S. M. Synoviae Clean chicks from primary breeding flocks and from which a random sample comprised of a minimum of 75 birds 50 percent of the birds in the flock, with a maximum of 200 birds and a minimum of 30 birds per flock or all birds in the flock if flock is less than 30 birds has been tested for M. synoviae as provided in (b) when more than 4 months of age or upon reaching sexual maturity: Provided, That to retain this classification, the flock shall be subjected to one of the following procedures: (A) At intervals of not more than 90 days, a random sample of serum or egg yolk or a targeted bird sanple of the Choanal palatine cleft / fissure area using appropriate swabs from all the birds in the flock if flock size is less than 30, but at least birds shall be tested: Provided, That a sample of fewer than birds may be tested at any one time, with the approval of the Official State Agency and the concurrence of the Service, provided that a minimum total of at least 30 birds or the entire flock if flock size is less than 30,per flock with a minimum of 15 birds per pen, whichever is greater, is tested each time and a total of at least birds is tested within each 90-day period; or (B) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with part 147 of this subchapter. (2) A participant handling U.S. M. Synoviae Clean products shall keep those products separate from other products in a manner satisfactory to the Official State Agency: Provided, That U.S. M. Synoviae Clean chicks from primary breeding flocks shall be produced in incubators and hatchers in which only eggs from flocks qualified under paragraph (d)(1)(i) or (d)(1)(ii) of this section are set. 11 P a g e

13 (3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter. Reason: We would like to request a change in the rule to standardize the requirements for breeding flocks to be either MG or MS Clean under subpart E. The current requirements for MG Clean and MS Clean are quite different, though the two diseases spread and infect birds similarly. We propose to change the MS Clean requirements so that equal numbers of birds will be tested compared to the MG Clean requirements. In addition, we propose that the language be changed to mention sampling for PCR testing rather than only serological testing for qualification. Sponsor: Dr. Sarah Mason Poultry NC Department of Agriculture and Consumer Services Veterinary Division 12 P a g e

14 Proposal No. 6 6B, 6C, 6D, 6E Definitions. Poultry. Domesticated chickens and turkeys fowl, including chickens, turkeys, ostriches, emus, rheas, cassowaries, water-fowl, and game birds, except doves and pigeons, that are bred for the primary purpose of producing eggs or meat. Reason: This would make the definition in Subpart A consistent with the poultry definition in Subpart A of 145 and Part Part is the general definitions for Part 146. Specific definitions for each of the poultry types are listed in Subpart B, C, D & E of 146. Sponsor: Jennifer Hall Kentucky Poultry Federation 13 P a g e

15 Proposal No. 7 Combined Inspections. (b) The records of all flocks maintained primarily for production of hatching eggs shall be examined annually by a State Inspector. Records shall include VS Form 9 2, Flock Selecting and Testing Report ; VS Form 9 3, Report of Sales of Hatching Eggs, Chicks, and Poults ; set and hatch records; egg receipts; and egg/chick orders or invoices. If records such as the VS Form 9-2 or other approved testing reports are not maintained at the hatchery, the hatchery personnel should make those forms or the location of the forms readily available to the state inspector before the hatchery inspection is performed. Records shall be maintained for 3 years. On-site inspections of flocks and premises will be conducted if the State Inspector determines that a breach of sanitation, blood testing, or other provisions has occurred for Plan programs for which the flocks have or are being qualified. Reason: 9-CFR is about hatchery inspections and the records that the OSA should be examining. Not many commercial hatcheries keep testing records for their breeder flocks at the hatchery. VS 9-2 Selecting and Testing Forms are included on the 9-9 Hatchery Inspection form. Historically all the information was probably kept at the hatchery but is now kept with the breeder departments. Sponsor: Jennifer Hall Kentucky Poultry Federation 14 P a g e

16 Proposal No. 8 Combined Authorized laboratories (b) Trained technicians. The testing procedures at the laboratory must be run or overseen by a laboratory technician who has attended and satisfactorily completed the official check-test proficiency for that assay. If the assay specific check test is not satisfactorily completed, the laboratory technician must attend and satisfactorily complete Service-approved laboratory workshops for Plan-specific diseases. within the past 4 years. Reason: Training in laboratories has changed over period of years. To account for specialized testing requirements and laboratory approval process in place, a National Animal Health Laboratory or AAVLD accredited lab will be exempted from requirement of attending and completing Service-approved laboratory workshops for Plan-specific diseases within the past 3 years. Webinar for annual updates after the meeting addressing the changes about laboratory procedures will be appreciated. Sponsor: Dr. Deepanker Tewari and Dr. Beate Crossley Pennsylvania and California Dr. Julie Helm and Dr. Nan Hanshaw South Carolina and Pennsylvania 15 P a g e

17 Proposal No. 9 D Participation. (a) Participating turkey flocks, and the eggs and poults produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart D. (b) Hatching eggs shallshould be nest clean. They may be fumigated in accordance with part 147 of this subchapter or otherwise sanitized. (c) Any nutritive material provided to poults must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in Reason: In the 2010 NPIP conference, Subparts B, C, G and H changed their requirements for hatching eggs to remove the requirement that they shall be fumigated to may be fumigated and changed the NPIP Provisions language to read as the proposal above. With the continued restrictions from OSHA and concerns related to staff safety with fumigation the Subpart D Turkey Breeding Flocks want to make the similar NPIP Provisions proposal change. Sponsor: Dr. David Hermes Perdue Farms 16 P a g e

18 Proposal No. 10 I Terminology and classification; flocks and products. (c) U.S. H5/H7 Avian Influenza Clean. This program is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of the H5/H7 subtypes of avian influenza. It is intended to determine the presence of the H5/H7 subtypes of avian influenza in meat-type waterfowl breeding flocks through routine surveillance of each participating breeding flock. A flock, and the hatching eggs and baby poultry produced from it, will qualify for this classification when the Official State Agency determines that it has met one of the following requirements: (1) It is a primary breeding flock in which a minimum of 30 birds have been tested negative to the H5/H7 subtypes of avian influenza as provided in (d) when more than 4 months of age. To retain this classification: (i) A sample of at least 30 birds must be tested and found to be negative at intervals of 90 days; or (ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds are tested within each 90- day period. (2) It is a multiplier breeding flock in which a minimum of 30 birds have been tested negative to the H5/H7 subtypes of avian influenza as provided in (d) when more than 4 months of age. To retain this classification: (i) A sample of at least 30 birds must be tested negative at intervals of 180 days; or (ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds are tested within each 180-day period. (3) A sample of at least birds must be tested and found negative to H5/H7 avian influenza within 21 days prior to movement to slaughter. Reason: In the 2012 NPIP conference Subparts B, D and G changed their requirements on the number of breeding birds to be tested for avian influenza prior to movement to slaughter. The change made the avian influenza testing sample number the same prior to movement to the corresponding meat-type slaughter plant. Aligning sample numbers across similar flocks simplifies plan participation. The Subpart I Meat-Type Waterfowl Breeding Flocks want to make the similar NPIP Provisions proposal change. Sponsor: Dr. Daniel Shafer Maple Leaf Farms 17 P a g e

19 Proposal No. 11 I Participation. Participating flocks of meat-type waterfowl and the eggs and baby poultry produced from them shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart I. (a) Started poultry shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in 145.5(a). (b) Hatching eggs produced by primary and multiplier breeding flocks shall should be nest clean. They may be fumigated in accordance with part 147 of this subchapter or otherwise sanitized. (c) Any nutritive material provided to baby poultry must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in Reason: In the 2010 NPIP conference, Subparts B, C, G and H changed their requirements for hatching eggs to remove the requirement that they shall be fumigated to may be fumigated and changed the NPIP Provisions language to read as the proposal above. With the continued restrictions from OSHA and concerns related to staff safety with fumigation the Subpart I Meat-Type Waterfowl Breeding Flocks want to make the similar NPIP Provisions proposal change. Sponsor: Dr. Daniel Shafer Maple Leaf Farms 18 P a g e

20 Proposal No. 12 Combined Inspections. (a) Each participating slaughter plant shall be audited at least once annually or a sufficient number of times each year to satisfy the Official State Agency that the participating slaughter plant is in compliance with the provisions of this part. The yearly audit will consist of an evaluation of 2 weeks' worth of records, selected at random, of the following data: (1) The actual flock slaughter date for each flock. This information must come from a verifiable source. Verifiable sources include electronic record systems that have oversight from the Department's Grain Inspectors, Packers and Stockyards Administration or Food Safety and Inspection Service (FSIS) documents such as FSIS Form (2) Laboratory test results for each flock slaughtered with the sample collection date and test result. The test must be NPIP-approved and performed in an authorized laboratory of the NPIP. (b) A flock will be considered to be not conforming to protocol if it meets the requirements as described in (a), (a) or (a). there are no test results available, if samples from the flock were not collected and tested within 21 days prior to slaughter, or if the test results for the flocks were not returned prior to movement to slaughter. (c) Two or more flocks that are found to be not conforming to protocol in the yearly audit for a slaughter plant shall be cause for a deficiency rating for that plant. However, if the root cause for the deficiency was identified, corrected, and documented, the plant will be eligible for an immediate reevaluation of 2 additional weeks' worth of records, again selected at random. If no more than one missed flock is identified in this reevaluation, the plant will be considered in compliance and no further action will be required. Plants found to be deficient must provide a written corrective action plan to the auditor within 2 weeks of receipt of the deficiency rating. A follow up audit on the information in paragraphs (a)(1) and (a)(2) of this section will occur within 90 days from the receipt of the corrective action plan. Slaughter plants will retain their classification and may continue to use the Plan emblem in 146.9(a) during this process. A failure on the follow up audit may result in disbarment from participation according to the procedures in (d) On-site inspections of any participating flocks and premises will be conducted if a State Inspector determines that a breach of testing has occurred for the Plan programs for which the flocks are certified. (e) The official H5/H7 LPAI testing records of all participating flocks and slaughter plants shall be examined annually by a State Inspector. Official H5/H7 LPAI testing records shall be maintained for 3 years. Reason: A problem was created in the language by a proposed change in 2012 NPIP conference. The proposed change inadvertently combined all the different allowed testing 19 P a g e

21 requirements for each Subpart 146C, 146D and 146E participating slaughter plants into only one limited set of testing requirements. It also inadvertently contradicted the requirement allowing for testing at the slaughter plant on a shift basis. This proposal will undo the inadvertently created problems and correct and improve the language to allow each Subpart 146C Meat-Type Chicken Slaughter Plants, 146D Meat-Type Turkey Slaughter Plants and 146E Commercial Waterfowl and Commercial Upland Game Bird Slaughter Plants to have and set their own testing requirements for their Subpart independent of each other. Moreover, referring to each appropriate NPIP Provisions Subpart number allows for future changes to the testing requirements by each Subpart 146C, 146D or 146E without having to change any language in the Inspections section. Sponsor: Paul Wm. Brennan Indiana State Poultry Association 20 P a g e

22 Proposal No. 13 6B Terminology and classification; flocks and products. (a)u.s. H5/H7 Avian Influenza Monitored (1)Table-egg layer pullet flocks. This program is intended to be the basis from which the table-egg layer industry may conduct a program to monitor for the H5/H7 subtypes of avian influenza. It is intended to determine the presence of the H5/H7 subtypes of avian influenza in table-egg layer pullets through routine surveillance of each participating commercial table-egg layer pullet flock. A flock will qualify for this classification when the Official State Agency determines that it has met one of the following requirements: (i) Table-egg layer pullet flocks. (i) It is a commercial table-egg layer pullet flock in which a minimum of 11 birds have been tested negative to the H5/H7 subtypes of avian influenza as provided in (b) within 30 days prior to movement; or (ii) It is a commercial table-egg layer pullet flock that has an ongoing active and diagnostic surveillance program for the H5/H7 subtypes of avian influenza in which the number of birds tested is equivalent to the number required in paragraph (a)(1)(i) of this section and that is approved by the Official State Agency and the Service. (2) Table-egg layer flocks. This program is intended to be the basis from which the table-egg layer industry may conduct a program to monitor for the H5/H7 subtypes of avian influenza. It is intended to determine the presence of the H5/H7 subtypes of avian influenza in table-egg layer through routine surveillance of each participating commercial table-egg layer flock. A flock will qualify for this classification when the Official State Agency determines that it has met one of the following requirements: (i) It is a commercial table-egg layer flock in which a minimum of 11 birds have been tested negative to for the H5/H7 subtypes of avian influenza as provided in (b) within 30 days prior to disposal; provided, that each premises is tested at least once every calendar year; or (ii) It is a commercial table-egg layer flock in which a minimum of 11 birds have been tested negative for the H5/H7 subtypes of avian influenza as provided in (b) within a 12-month period; or (iii) It is a commercial table-egg layer flock that has an ongoing active and diagnostic surveillance program for the H5/H7 subtypes of avian influenza in which the number of birds tested is equivalent to the number required in paragraph (a)(2)(i) or paragraph (a)(2)(ii) of this section and that is approved by the Official State Agency and the Service. Reason: This proposal is intended to provide a means to ensure that premises that have only a small number of flocks, that may be molted and test 11 birds per flock within 30 days of disposal as required in 9 CFR (a)(2)( i ) are tested at least once every calendar year. Sponsor: Chicken and Egg Association of Minnesota (CEAM) 21 P a g e

23 Proposal No. 14 Combined Table of Contents. I propose that all four Table of Contents be combined into one Table of Contents and put at the beginning of the Regulations on page 3. Reason: It is currently difficult to navigate the NPIP regulations with four Table of Contents. Many people that initially use the Regulations don't even know there is more than one Table of Contents, let alone know where they are. Using the Regulations would be much easier if there was only one Table of Contents. Currently there are four Table of Contents spread throughout the Regulations. The Table of Contents for the Breeding Poultry section is on page 3, the Table of Contents for the Commercial Poultry section is on page 69, the Table of Contents for the Auxiliary Provisions is on page 87 and the Table of Contents for Part 56, C Control of H5/H7 Low Pathogenic Avian Influenza is on page 98. Sponsor: John Metzer Metzer Farms 22 P a g e

24 Proposal No. 15 Combined Testing. (b) For Mycoplasma gallisepticum, M. meleagridis, and M. synoviae. (1) The official tests for M. gallisepticum, M. meleagridis, and M. synoviae shall be the serum plate agglutination test, the tube agglutination test, the hemagglutination inhibition (HI) test, the microhemagglutination inhibition test, the enzyme-linked immunosorbent assay (ELISA) test 3, a polymerase chain reaction (PCR)-based test, or a combination of two or more of these tests. The HI test or the microhemagglutination inhibition test shall be used to confirm the positive results of other serological tests. HI titers of 1:40 or more may be interpreted as suspicious, and final judgment must be based on further samplings and/or culture of reactors. Tests must be conducted in accordance with paragraph (b) and in accordance with part 147 of this subchapter. Reason: Sponsor: Tube agglutination test should be removed because it is now outdated and no longer in common use. The terminology microhemagglutination is also outdated. Dr. Naola Ferguson-Noel University of Georgia-PDRC 23 P a g e

25 Proposal No. 16 Combined Testing. (b) For Mycoplasma gallisepticum, M. meleagridis, and M. synoviae. (1) The official tests for M. gallisepticum, M. meleagridis, and M. synoviae shall be the serum plate agglutination test, the tube agglutination test, the hemagglutination inhibition (HI) test, the microhemagglutination inhibition test, the enzyme-linked immunosorbent assay (ELISA) test 3, a polymerase chain reaction (PCR)-based test, or a combination of two or more of these tests. If the tube agglutination, ELISA, or serum plate test is positive, the hemaglutination inhibition (HI) test, microhemagglutination inhibition test or a molecular examination procedure shall be conducted. The HI test or the microhemagglutination inhibition test shall be used to confirm the positive results of other serologi-cal tests. HI titers of 1:40 or more may be interpreted as suspicious, and final judgment must be based on further samplings and/or culture of reactors. Tests must be conducted in accordance with paragraph (b) and in accordance with part 147 of this subchapter. Reason: The language in Program Standards Subpart A (5)(a)(2), former is inconsistent with (b) (b) does not state that a molecular examination procedure can be conducted after positive serological test and the program standards specifically allow this. Sponsor: Jennifer Hall Kentucky Poultry Federation 24 P a g e

26 Proposal No. 17 Combined 56.1 Definitions. Breeding flock. A flock that is composed of stock that has been developed for commercial egg or meat production and is maintained for the principal purpose of producing chicks or poults for the ultimate production of eggs or meat for human consumption. Reason: Current definition omits newly hatched turkeys. Another suggestion would be to use progeny instead of chicks and poults such as the definition of multiplier breeding flock in Part Sponsor: Jennifer Hall Kentucky Poultry Federation 25 P a g e

27 Proposal No. 18 Combined Testing. (a) For Pullorum-Typhoid. (1) The official blood tests for pullorum-typhoid shall be the standard tube agglutination test, the microagglutination test, the enzyme-linked immunosorbent assay test (ELISA), or the rapid serum test for all poultry; and the stained antigen, rapid whole-blood test for all poultry except turkeys. Office blood tests must be conducted in accordance with part 147 of this subchapter or according to literature provided by the producer. Only antigens approved by the Department and of the polyvalent type shall be used for the rapid whole-blood and tube agglutination tests. Each serial of tube antigen shall be submitted by the antigen producer to the Department for approval upon manufacture and once a year thereafter as long as antigen from that serial continues to be made available for use. All microtest antigens and enzyme-linked immunosorbent assay reagents shall also be approved by the Department. (2) [Reserved] (3) There shall be an interval of at least 21 days between any official blood test and any previous test with pullorum-typhoid antigen. (4) [Reserved] (5) The official blood test shall include the testing of a sample of blood from each bird in the flock: Provided, That under specified conditions (see applicable provisions of , , , , and , , , and ) the testing of a portion or sample of the birds may be used in lieu of testing each bird. Reason: (a)(5) should reference all the subparts. B, C, D, E, F, G, H, & I. The three not included are the most recent subparts added to the 9CFR Part 145. Sponsor: Jennifer Hall Kentucky Poultry Federation 26 P a g e

28 Proposal No. 19 H Terminology and classification; flocks and products. (f) U.S. Salmonella Monitored. This program is intended to be the basis from which the breeding-hatching industry may conduct a program for the prevention and control of salmonellosis. It is intended to reduce the incidence of Salmonella organisms in hatching eggs and chicks through an effective and practical sanitation program at the breeder farm and in the hatchery. This will afford other segments of the poultry industry an opportunity to reduce the incidence of Salmonella in their products. (1) A flock and the hatching eggs and chicks produced from it that have met the following requirements, as determined by the Official State Agency. (i) The flock is maintained in accordance with part 147 of this subchapter with respect to flock sanitation, cleaning and disinfection, and Salmonella isolation, sanitation, and management; (ii)measures should be implemented to control Salmonella challenge through the feed, feed storage and feed transport. If feed contains animal protein, the protein products must have a minimum moisture content of 14.5 percent and must have been heated throughout to a minimum temperature of 190 F or above, or to a minimum temperature of 165 F for at least 20 minutes, or to a minimum temperature of 184 F under 70 lbs. pressure during the manufacturing process; (iii) Feed shall be stored and transported in a manner to prevent possible contamination; (iiiv) Chicks shall be hatched in a hatchery whose sanitation is maintained in accordance with part 147 of this subchapter and sanitized or fumigated in accordance with part 147 of this subchapter. (iv) An Authorized Agent shall take environmental samples from the hatchery every 30 days; i.e., meconium or chick papers. An authorized laboratory for Salmonella shall examine the samples bacteriologically; (vi) An Authorized Agent shall take environmental samples in accordance with part 147 of this sub-chapter from each flock at 4 months of age and every 30 days thereafter. An authorized laboratory for Salmonella shall examine the environmental samples bacteriologically. All Salmonella isolates from a flock shall be serogrouped and shall be reported to the Official State Agency on a monthly basis; (vii) Owners of flocks may vaccinate with a para-typhoid vaccine: Provided, That a sample of 350 birds, which will be banded for identification, shall remain unvaccinated until the flock reaches at least 4 months of age to allow for the serological testing required under paragraph (f)(1)(vi) of this section. (viii) Any flock entering the production period that is in compliance with all the requirements of (f) with no history of Salmonella isolations shall be considered 27 P a g e