Contact Representatives

The regulations in Sec. Sec. 145.2(a) and 146.2(a) state that the Department cooperates through a Memorandum of Understanding with the Official State Agency in the administration of the Plan. One key component of the Memorandum of Understanding is the Official State Agency's designation of a contact representative to serve as a liaison between the Service and the Official State Agency. The contact representative facilitates communication between the two organizations.

While we have requested that Official State Agencies designate contact representatives in their Memoranda of Understanding, we currently do not require them to do so in the regulations. However, because this position is crucial to the effective operation of the NPIP, we are proposing to make the designation of a contact representative by the Official State Agency a requirement. To accomplish this, we would add a sentence to the end of Sec. Sec. 145.2(a) and 146.2(a) that would read as follows: ``In the Memorandum of Understanding, the Official State Agency must designate a contact representative to serve as a liaison between the Service and the Official State Agency.''

Official Tests for Avian Influenza

The regulations in Sec. Sec. 145.14(d) and 146.13(b) set out the NPIP approved tests for avian influenza in breeding poultry and commercial poultry, respectively. These paragraphs provide for the use of the agar gel immunodiffusion (AGID) test, under the procedures set forth in Sec. 147.9, and the enzymelinked immunosorbent assay (ELISA). The AGID test must be conducted on all ELISApositive samples. Positive tests by AGID or ELISA must be further tested by Federal Reference Laboratories. Final judgment may be based upon further sampling or culture results. In addition, the tests must be conducted using antigens or test kits approved by the Service. Test kits for ELISA must be licensed by the Service and approved by the Official State Agency, and tests must be performed in accordance with the recommendations of the producer or manufacturer.

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Paragraph (b) of Sec. 146.13 further requires that the official determination of a flock as positive for the H5 or H7 subtypes of low pathogenic avian influenza may be made only by the Service's National Veterinary Services Laboratories (NVSL). This paragraph also states that the AGID and ELISA tests may be performed either on egg yolk or blood samples. Otherwise, Sec. Sec. 145.14(d) and 146.13(b) are substantively identical.

We are proposing to amend Sec. Sec. 145.14(d) and 146.13(b) to include two agent detection tests in addition to the AGID and ELISA antibody detection tests. To accommodate the addition of the agent detection tests, we would reorganize Sec. Sec. 145.14(d) and 146.13(b) by splitting each of those paragraphs into two subparagraphs. The requirements related to the antibody detection tests would then appear under the heading ``Antibody detection tests'' in Sec. Sec. 145.13(d)(1) and 146.13(b)(1), respectively. We would indicate in both paragraphs that the AGID test must be conducted using reagents approved by the Department and the Official State Agency, and that it can be performed on egg yolk or blood samples. (The ELISA could still be performed on egg yolk or blood samples as long as it is performed in accordance with the recommendations of the producer or manufacturer.)

We are also proposing to add the new provisions for agent detection tests in Sec. Sec. 145.14(d)(2) and 146.13(b)(2), respectively. Authorized laboratories would be allowed to perform tests that detect influenza A matrix gene or protein, but not tests that determine hemagglutinin or neuraminidase subtypes; all tests that determine those subtypes should be performed by National Animal Health Laboratory Network members, to ensure the reliability of their results. Samples for agent detection testing would be collected from naturally occurring flock mortality or clinically ill birds, to increase the sensitivity of the testing.

We would provide for the use of two agent detection tests: The real time reverse transcriptase/polymerase chain reaction (RRTPCR) assay and the USDAlicensed type A influenza antigen capture immunoassay (ACIA). The RRTPCR and the ACIA are rapid flock screening tools that can provide highly specific, scalable results on the same day (the RRT PCR within 3 to 5 hours and the ACIA within 15 minutes). These tests would have significant value both as screening tests and as part of initial State response and containment plans to control avian influenza (as described in 9 CFR 56.10).

The RRTPCR tests would have to be conducted using reagents approved by the Department and the Official State Agency. The RRTPCR would have to be conducted using the NVSL official protocol for RRTPCR (AVPR01510) and be conducted by personnel who have passed an NVSL proficiency test. Positive results from the RRTPCR would have to be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment could be based upon further sampling and appropriate tests for confirmation.

The USDAlicensed type A influenza ACIA would have to be conducted using test kits approved by the Department and the Official State Agency and would have to be conducted in accordance with the recommendations of the producer or manufacturer. Positives on the ACIA would have to be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment could be based upon further sampling and appropriate tests for confirmation.

Finally, we would amend Sec. 145.14(d) to indicate there as well that the official determination of a flock as positive for the H5 or H7 subtypes avian influenza may be made only by NVSL.

In a related change, we are proposing to move the requirements in Sec. 145.15, ``Approved tests,'' to a new Sec. 147.52. We would also add a new Sec. 147.51 to describe the requirements for authorized laboratories; these proposed changes are discussed later in this document under the heading ``Authorized Laboratories.'' The new Sec. Sec. 147.51 and 147.52 would be placed in a new subpart in 9 CFR part 147 to collect the provisions governing approval of laboratories and tests.
Diagnostic Surveillance Plan for H5/H7 Low Pathogenic Avian Influenza

In an interim rule published and effective September 26, 2006 (71 FR 5360156333, Docket No. APHIS20050109), we amended the regulations to establish a voluntary control program for the H5/H7 subtypes of low pathogenic avian influenza (H5/H7 LPAI) in commercial poultry specifically, in tableegg layers, meattype chickens, and meattype turkeys. This voluntary control program includes a requirement for participating States to develop a diagnostic surveillance program that includes all poultry in the State, not just commercial poultry. The regulations governing the development of such a program are found in Sec. 146.14. Participation in the voluntary control program is a condition for States and large producers to be eligible to receive 100 percent indemnity for costs related to an outbreak of H5/H7 LPAI under 9 CFR part 56.

We are proposing to add a new Sec. 145.15 that duplicates the regulations in Sec. 146.14 to ensure that participants in the NPIP for breeding poultry are aware that States participating in the voluntary control program must develop a diagnostic surveillance program that includes both breeding and commercial poultry.
Testing Requirements for U.S. Avian Influenza Clean Programs for Multiplier EggType Chicken, MeatType Chicken, and Turkey Breeding Flocks

The regulations set out requirements for the U.S. Avian Influenza Clean classifications for multiplier eggtype chicken breeding flocks, multiplier meattype chicken breeding flocks, and multiplier turkey breeding flocks at Sec. Sec. 145.23(h)(2), 145.33(l)(2), and 145.43(g)(2), respectively. These paragraphs all require that, for a multiplier breeding flock to retain the U.S. Avian Influenza Clean classification, a sample of at least 30 birds must be tested negative at intervals of 180 days, or 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 is tested within each 180 day period.

However, due to the virulence of the avian influenza virus and the minute amount of infective fecal material and respiratory secretions required to transmit the virus and infect a flock, industry participants have determined that the 180day interval between tests is too long to provide satisfactory assurance that the flocks being tested are U.S. Avian Influenza Clean for these types of poultry.

The U.S. Avian Influenza Clean programs for primary breeding flocks of eggtype chickens, meattype chickens, and turkeys (in Sec. Sec. 145.73(f)(1), 145.83(g)(1), and 145.43(g)(1), respectively) require testing every 90 days. We believe this interval is appropriate for all flocks of these types of poultry. Therefore, we are proposing to replace references to the 180day testing interval in Sec. Sec. 145.23(h)(2), 145.33(l)(2), and 145.43(g)(2) with references to a 90 day testing interval. We believe this change would help to ensure that flocks with the U.S. Avian Influenza Clean classification are free of avian influenza.

The regulations currently require that 30 birds be tested negative at intervals of 180 days. For multiplier breeding flocks of eggtype chickens and turkeys, we would retain the requirement that 30 birds be tested while reducing the
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interval at which they are tested to 90 days. For multiplier breeding flocks of meattype chickens, we would require that 15 birds be tested negative every 90 days. Eggtype chicken and turkey breeding flocks receive much more regular supervision than meattype chicken breeding flocks, and those industries determined that testing the same number of birds over a shorter interval would be practical. The changes to the testing requirement for meattype chicken breeding flocks would result in the same number of these birds being tested as are tested under the current regulations, but would still increase the assurance that the flocks tested are U.S. Avian Influenza Clean by providing more frequent results.

The waterfowl, exhibition poultry, and game bird breeding industry considered this change and determined that it is not appropriate at this time; multiplier waterfowl, exhibition poultry, and game bird breeding flocks participating in the U.S. Avian Influenza Clean program would continue to be tested at intervals of 180 days.
Option for Reporting Poultry Sales for Waterfowl, Exhibition Poultry, and Game Bird Breeding Flocks and Products

The regulations for the participation of waterfowl, exhibition poultry, and game bird breeding flocks in Sec. 145.52 state that, subject to the approval of the Service and the Official State Agencies in the relevant States, participating flocks may report poultry sales by using printouts of computerized monthly shipping and receiving reports in lieu of Veterinary Services (VS) Form 93, ``Report of Sales of Hatching Eggs, Chicks, and Poults.'' The regulations do not state what information would need to be included in such monthly shipping and receiving reports if they are used in lieu of VS Form 93. We are proposing to add requirements for these monthly shipping and receiving reports to the regulations.

The regulations would state specifically that a hatchery invoice form (93I) approved by the Official State Agency and the Service may be used in lieu of VS Form 93 to identify poultry sales to clients. If the selling hatchery uses the 93I form, we would require that the following information be included on the form:

This change would ensure that reports provided in lieu of VS Form 93 would have standard information and make it easy to use such reports in place of that form.
New U.S. Avian Influenza Clean Classification for Ostrich, Emu, Rhea, and Cassowary Breeding Flocks and Products

Subpart F of 9 CFR part 145 contains the special Plan provisions for ostrich, emu, rhea, and cassowary breeding flocks and products. Section 145.63 contains the requirements for ostrich, emu, rhea, and cassowary breeding flocks to earn the U.S. PullorumTyphoid Clean classification. We are proposing to add a U.S. Avian Influenza Clean classification to Sec. 145.63, in a new paragraph (b). This classification would be the basis from which the breedinghatchery industry may conduct a program for the prevention and control of avian influenza. It would be intended to determine the presence of avian influenza in all ostrich, emu, rhea, and cassowary breeding flocks through routine serological surveillance of each participating breeding flock.

Acceptable tests would include antigen and antibody detection tests, as approved by the Official State Agency.

An ostrich, emu, rhea, or cassowary breeding flock, and the hatching eggs and chicks produced from it, would qualify for this classification when the Official State Agency determines that it has met one of the following requirements:

These requirements are similar to the requirements in the U.S. Avian Influenza Clean classification for waterfowl, exhibition poultry, and game bird breeding flocks and products.

Audit Process for Commercial Poultry Slaughter Plants

In part 146, which contains the NPIP provisions for commercial poultry, Sec. 146.11 sets out the process for inspecting participating slaughter plants. Paragraph (a) of Sec. 146.11 requires each participating slaughter plant to 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 9 CFR part 146. Paragraph (b) provides that onsite 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. Paragraph (c) provides that the official H5/H7 LPAI testing records of all participating flocks and slaughter plants shall be examined annually by a State Inspector and that official H5/H7 LPAI testing records shall be maintained for 3 years.

The regulations currently do not provide any detail regarding the audit process described in paragraph (a). We are proposing to describe this process in detail in the regulations, to inform regulated parties, trading partners, and the general public regarding the information we examine and the consequences if an audit finds that a slaughter plant is not complying with the regulations.

The yearly audit would consist of an evaluation of 2 weeks' worth of records,
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selected at random, of the following data:

We would redesignate current paragraphs (b) and (c) as paragraphs (d) and (e), respectively, and add new paragraphs (b) and (c) to further describe the audit process. Under proposed paragraph (b), a flock would be considered to be not conforming to protocol if there are no test results available, if the flock was not tested within 21 days before slaughter, or if the test results for the flock were not returned before slaughter.

Under proposed paragraph (c), two or more flocks that are found to be not conforming to protocol in the yearly audit for a slaughter plant would be cause for a deficiency rating for that plant. However, if the root cause for the deficiency was identified, corrected, and documented, the plant would be eligible for an immediate reevaluation of 2 additional weeks' worth of records, again selected at random. If no more than one missed flock was identified in this reevaluation, the plant would be considered in compliance and no further action would be required. Plants found to be deficient would have to provide a written corrective action plan to the auditor within 2 weeks of receipt of the deficiency rating. A followup audit on the information in proposed paragraphs (a)(1) and (a)(2) would occur within 90 days from the receipt of the corrective action plan. Slaughter plants would retain their Plan classification and could continue to use the Plan emblem during this process. However, a failure on the followup audit could result in disbarment from participation in the NPIP according to the procedures in Sec. 146.12.

Sampling at Commercial MeatType Turkey Slaughter Plants

The regulations in Sec. 146.43(a) set out the requirements meat type turkey slaughter plants must fulfill in order to qualify for the U.S. H5/H7 Avian Influenza Monitored classification. Paragraphs (a)(1) and (a)(2) offer two options for qualifying for the classification: The plant must either test a sample of a minimum of 60 birds each month for antibodies to type A avian influenza virus or have 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 60 each month and that is approved by the Official State Agency and the Service.

We are proposing to amend paragraph (a)(1) to indicate that a participating meattype turkey slaughter plant may accept only meat type turkeys from flocks where a minimum of 6 birds per flock has tested negative for antibodies to type A avian influenza virus with an approved test no more than 21 days prior to slaughter. This level of testing is sufficient to establish the meattype turkey slaughter plant as U.S. H5/H7 Avian Influenza Monitored under the Plan.

The proposed provisions would also explicitly allow for testing at the flock level (prior to slaughter), an option that has been requested by the meattype turkey industry. Testing at slaughter would still be authorized under paragraph Sec. 146.43(a)(2), which allows slaughter plants to use any 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) and that is approved by the Official State Agency and the Service. Testing at slaughter could fulfill this requirement, subject to approval by the Official State Agency and the Service.
New U.S. H5/H7 Avian Influenza Classification for RaisedforRelease Upland Game Birds, RaisedforRelease Waterfowl, Commercial Upland Game Birds and Commercial Waterfowl

The regulations in 9 CFR part 146 provide for the participation of commercial tableegg layers, commercial meattype chickens, and commercial meattype turkeys in the NPIP and in the U.S. H5/H7 Avian Influenza Monitored classification. The commercial upland game bird and waterfowl industries and the raisedforrelease upland game bird and waterfowl industries have expressed interest in controlling H5/H7 avian influenza in their flocks by participating in part 146 and in a U.S. H5/H7 Avian Influenza Monitored classification. In this document, we are proposing to provide for such a classification.

We would add provisions for the participation of these birds in the NPIP in a new Subpart E of part 146, titled ``Special Provisions for Commercial Upland Game Birds, Commercial Waterfowl, RaisedforRelease Upland Game Birds, and RaisedforRelease Waterfowl.'' Specifically, the subpart would provide for the participation of commercial upland game bird slaughter plants, commercial waterfowl slaughter plants, raisedforrelease upland game bird premises, and raisedforrelease waterfowl premises in the Plan. It would also describe the testing that would be required for commercial upland game bird and commercial waterfowl slaughter plants and raisedforrelease upland game bird and waterfowl premises to achieve the U.S. H5/H7 Avian Influenza Monitored classification.

Section 146.51 of this new subpart would define the types of birds to which these special provisions would apply as follows:

Commercial upland game birds. Upland game bird pheasants, quail, or partridges grown under confinement for the primary purpose of producing meat for human consumption.

Commercial waterfowl. Domesticated ducks or geese grown under confinement for the primary purpose of producing meat for human consumption

Raisedforrelease upland game birds. Pheasants, quail, and partridge that are raised under confinement for release in game preserves and are not breeding stock.

Raisedforrelease waterfowl. Waterfowl that are raised under confinement for release in game preserves and are not breeding stock.

This section defines commercial upland game bird and commercial waterfowl slaughter plants as plants that are federally inspected or under State inspection that FSIS has recognized as equivalent to Federal inspection. It also defines shift as: ``The working period of a group of employees who are on duty at the same time.''

Section 146.52, ``Participation,'' would state that participating commercial upland game bird slaughter plants, commercial waterfowl slaughter plants, raisedforrelease upland game bird premises, and raisedforrelease waterfowl premises shall comply with applicable general provisions of subpart A of part 146 and the special provisions of proposed subpart E, which include the proposed testing requirements. However, the section would provide exemptions from the special provisions of subpart E for:

The proposed size standard for commercial waterfowl and commercial upland game bird slaughter plants is consistent with the National Duck Council's definitions for such plants. The proposed size standard for raisedforrelease upland game bird premises and raisedforrelease waterfowl premises is consistent with the North American Gamebird Association's definition of a commercial premises of these types.

Section 146.53, ``Terminology and classification; slaughter plants and premises,'' would set out active surveillance requirements for participating commercial upland game bird slaughter plants, commercial waterfowl slaughter plants, raisedforrelease upland game bird premises, and raisedforrelease waterfowl premises.

Paragraph (a) would set out active surveillance requirements for commercial upland game bird slaughter plants and commercial waterfowl slaughter plants. The active surveillance requirements we are proposing to add in Sec. 146.53(a) are intended for commercial upland game bird slaughter plants and commercial waterfowl slaughter plants that slaughter 50,000 or more of these types of poultry annually. However, smaller commercial upland game bird slaughter plants and commercial waterfowl slaughter plants are eligible to participate in the NPIP, as long as the State in which they are located participates in the NPIP. We believe that diagnostic surveillance in accordance with Sec. 146.14 and inspections in accordance with Sec. 146.11, which are required in the general provisions in subpart A, are adequate to determine whether H5/H7 LPAI is present on such premises.

Under paragraph (a) of proposed Sec. 145.53, a commercial upland game bird slaughter plant or commercial waterfowl slaughter plant would be eligible for the U.S. H5/H7 Avian Influenza Monitored classification if it meets one of the following requirements:

Both of the first two of these proposed testing requirements would be sufficient to establish the commercial waterfowl or commercial upland game bird slaughter plants as U.S. H5/H7 Avian Influenza Monitored under the Plan, consistent with the other U.S. H5/H7 Avian Influenza Monitored classifications in 9 CFR part 146. Allowing participating slaughter plants to choose between them would give the slaughter plants some flexibility.

Any ongoing active and diagnostic surveillance program that is approved by the Official State Agency and APHIS would have to test a number of birds equivalent to the other two options, but this by itself would not be sufficient to secure approval for the program; the Official State Agency and APHIS would have to agree that the detailed testing plan for the alternate program is sufficient to establish a level of confidence for the detection of AI that is equivalent to that of the other two options. Allowing participating slaughter plants to develop an alternative ongoing active and diagnostic surveillance program of equivalent efficacy would give the plants some additional flexibility.

Paragraph (b) would set out active surveillance requirements for raisedforrelease upland game bird premises and raisedforrelease waterfowl premises. The active surveillance requirements we are proposing to add in Sec. 146.53(b) are intended for raisedforrelease upland game bird premises and raisedforrelease waterfowl premises that raise 25,000 or more of these types of poultry annually. However, smaller raisedforrelease upland game bird premises and raisedfor release waterfowl premises are eligible to participate in the NPIP, as long as the State in which they are located participates in the NPIP. We believe that diagnostic surveillance in accordance with Sec. 146.14, which is required in the general provisions in subpart A, is adequate to monitor whether H5/H7 LPAI is present on such premises.

Under paragraph (b), a raisedforrelease upland game bird premises or raisedforrelease waterfowl premises would qualify for the U.S. H5/ H7 Avian Influenza Monitored classification when the Official State Agency determines that a representative sample of 30 birds from the participating premises has been tested with negative results for the H5/H7 subtypes of avian influenza every 90 days. This testing would be for premises monitoring purposes and would not be intended to establish the premises as free of the H5/H7 subtypes of avian influenza.

Because this change would expand the ranks of commercial poultry producers who are eligible to participate in the Plan, we would amend the definition of commercial meattype flock in Sec. 146.1 to include commercial upland game birds and commercial waterfowl; amend Sec. 146.3 to reflect the participation of the commercial upland game bird slaughter plants, commercial waterfowl slaughter plants, raisedfor release upland game bird premises, and raisedforrelease waterfowl premises; make appropriate changes to Sec. 146.6 to reflect the addition of the two new types of slaughter plants; and amend Sec. 146.9 to indicate that the new participants may use the U.S. H5/H7 Avian Influenza Monitored illustrative design.

We would amend Sec. 147.45 to indicate that each cooperating State is entitled to one delegate for the program we are proposing to describe in a new subpart E in 9 CFR part 146. (In addition, in a final rule that was published in the Federal Register on January 12, 2007 (72 FR 14161426, Docket No. APHIS20060008), and effective on February 12, 2007, we added new subparts G and H for primary eggtype and meat type chicken breeding flocks, but neglected to update Sec. 147.45 to indicate that each cooperating State would be entitled to one delegate for each of these subparts. We are proposing to correct that error in this document.) We would also amend Sec. 147.46(a) to establish a committee to give preliminary considerations to proposed changes falling in the field of commercial upland game birds and waterfowl and raisedforrelease upland game birds and waterfowl.
Amendment to Standard AGID Test Procedure for Avian Influenza

The regulations in Sec. 147.9(a) describe the standard AGID test procedure for avian influenza. Within Sec. 147.9(a), paragraph (a)(4)(i)(F) describes two options for placing AGID antigen, AI AGID positive control antiserum, and test sera into wells formed in agar on a petri plate. Paragraph (a)(4)(i)(F)(1) describes a method (shown in figure 1) in which AGID antigen is placed in the center well, AI AGID positive control antiserum is placed in each of two opposite wells, and test sera are placed in each of the four remaining wells. Paragraph (a)(4)(i)(F)(2) describes a method (shown in figure 2) in which [[Page 30534]]
AGID antigen is placed in the center well, AI AGID positive control antiserum is placed in each of three alternate peripheral wells, and test sera are placed in each of the three remaining wells.
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The arrangement in figure 1 provides a positive control line on one side of the test serum, thus providing for the development of lines of identity; the arrangement in figure 2 provides a positive control line on each side of the test serum, thus providing for the development of lines of identity on both sides of each test serum. While most positive test sera will result in clearcut evidence of a positive agar gel reaction, there are times early in AI infection when the test sera may only contain small amounts of antibody. This will cause the tips of the lines of identity to bend slightly inward, which is indicative of a weak positive on the AGID. Having two lines converging towards a test well provides a better opportunity to have an accurate and precise interpretation of the positive reaction or to distinguish a nonspecific reaction.

Therefore, we are proposing to remove the option described in paragraph (a)(4)(i)(F)(1) from the regulations. A revised (a)(4)(i)(F) would only set out the second option; figure 1 would be removed, and figures 2 and 3 would be redesignated as figures 1 and 2, respectively. Laboratory Procedures for New RealTime Polymerase Chain Reaction Test for Mycoplasma Gallisepticum

Subpart D of 9 CFR part 147 sets out procedures to follow when performing molecular examinations for Plan diseases. We are proposing to add a new description of the laboratory procedures recommended for the realtime polymerase chain reaction (PCR) test for Mycoplasma gallisepticum (MGLP ReTi) in Sec. 147.31. The method described in proposed Sec. 147.31 has been published in peerreviewed journals and validated with over 1,200 samples. It has also been shown to be more sensitive than traditional isolation methods. Adding this testing procedure to the regulations would keep Plan molecular examination procedures current with recent science. A detailed description of the procedure can be found in the text of proposed Sec. 147.31 that appears at the end of this document.

In a related change, we are proposing to add a new paragraph (b)(5) to Sec. 145.14(b), which describes the official tests for M. gallisepticum and M. synoviae. This new paragraph would state that the official molecular examination procedures for M. gallisepticum and M. synoviae are the PCR test described in Sec. 147.30 and the realtime PCR test described in proposed Sec. 147.31. Adding this language in Sec. 145.14(b)(5) would clearly indicate that the tests described in Sec. 147.30 and proposed Sec. 147.31 are considered official tests of the Plan.

Amendments to General Conference Committee Description

The regulations in Sec. 147.43(d) describe the duties and functions of the General Conference Committee (GCC) of the National Poultry Improvement Plan in advising and administering the Plan. We are proposing to make two changes in this paragraph:

Authorized Laboratories

In the definitions in Sec. Sec. 145.1 and 146.1, authorized laboratory is defined as a laboratory designated by an Official State Agency, subject to review by the Service, to perform the blood testing and bacteriological examinations provided for in 9 CFR part 145. Under this definition, the Service's review will include, but will not necessarily be limited to, checking records, laboratory protocol, checktest proficiency, periodic duplicate samples, and peer review. A satisfactory review will result in the authorized laboratory being recognized by the Service as a nationally approved laboratory qualified to perform the blood testing and bacteriological examinations provided for in 9 CFR part 145 or the diagnostic assays provided for in 9 CFR part 146.

In this document, we are proposing to add more detailed requirements for authorized laboratories to the regulations. We would establish a new Sec. 147.51 with the heading ``Authorized laboratory minimum requirements.'' This section would be added in a new subpart F with the heading ``Authorized laboratories and approval of tests.''

The introductory text of Sec. 147.51 would state that the section contains minimum requirements that 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 and reported as described in 9 CFR part 147. A satisfactory evaluation would 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 9 CFR part 147. The minimum requirements would be the following:

These requirements would ensure that authorized laboratories perform accurate and rigorous testing in the service of Plan programs.

To reflect this change, we would revise the definitions of authorized laboratory in Sec. Sec. 145.1 and 146.1. The new definitions would read: ``An authorized laboratory is a laboratory that meets the requirements of Sec. 147.51 and is thus qualified to perform the assays described in part 147 of this subchapter.''

Miscellaneous Change

In the January 2008 final rule mentioned earlier in this document, we removed and reserved paragraph (b) of Sec. 147.11, which contained footnotes 8 through 11 in 9 CFR part 147. However, we neglected to redesignate the other footnotes in that part to reflect the removal of those four footnotes. In this proposal, we would correct that error by redesignating footnotes 12 through 24 as footnotes 8 through 20. Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

We are proposing to amend the Plan and its auxiliary provisions by providing new or modified sampling and testing procedures for Plan participants and participating flocks. The proposed changes were voted on and approved by the voting delegates at the Plan's 2006 National Plan Conference. These changes would keep the provisions of the Plan current with changes in the poultry industry and provide for the use of new sampling and testing procedures.

The United States is the world's largest poultry producer, the secondlargest egg producer, and the largest exporter of poultry meat. U.S. poultry meat production totals over 42 billion pounds annually; over fourfifths is broiler meat, most of the remainder is turkey meat, and a small fraction is other chicken meat. Cash receipts (see table 1) from sales of poultry and eggs (broilers, farm chickens, eggs, turkey, ducks, and other poultry) were about $28.9 billion in 2005 (with preliminary value for 2006 and forecasted value for 2007 being a little higher).\1\ Of this total, 72 percent was from broilers, 14 percent from eggs, 11 percent from turkeys, and 3 percent from other poultry. \1\ USDA/Economic Research Service (ERS), Farm Income/Cash receipts, 20022007.
Table 1.Cash Receipts for Poultry and Eggs, United States, 200005, 2006, and 2007 Commodity 2002 2003 2004 2005 2006 \P\ 2007 \F\ $1,000
Poultry/eggs.......................... 21,138,999 23,959,134 29,540,692 28,903,545 27,700,000 29,600,000 Broilers.............................. 13,437,700 15,214,945 20,446,096 20,901,934 19,000,000 20,100,000 Farm chickens......................... 49,850 47,508 57,260 63,963 + + Chicken eggs.......................... 4,232,433 5,273,099 5,239,082 4,000,142 4,400,000 5,100,000 Turkeys............................... 2,643,273 2,631,862 2,995,802 3,157,637 3,500,000 3,500,000 Ducks................................. 15,300 19,200 20,900 21,390 + + Other poultry......................... 760,443 772,521 781,553 758,479 800,000 900,000 P = preliminary, F = forecast, + = included in other poultry. Source: USDA/Economic Research Service (ERS), Farm Income/Farm cash Receipts, 19242005, 2006\P\, and 2007\F\) (http://www.ers.usda.gov/data/FarmIncome/ finfidmuxls.htm).

In terms of tonnage, poultry production and trade exceeds that of beef or pork. For instance, in 2006, the U.S. produced 41.4 billion pounds of poultry meat, compared with 26.2 billion pounds of beef and 21 billion pounds of pork. The U.S. also produced 6.5 billion dozen eggs in 2006. Per capita consumption of poultry meat (103.8 pounds in 2006) exceeds per capita consumption of both beef (65.7 pounds) and pork (49.3 pounds). Furthermore, the U.S. exports more poultry meat (5.8 billion pounds in 2006) than beef and veal (1.2 billion pounds) or pork (3 billion pounds).\2\
\2\ USDA/ERS, Livestock, Dairy, and Poultry Outlook/LDPM158, August 20, 2007.

Broiler production is concentrated in a group of States stretching from Delaware south along the Atlantic coast to Georgia, then westward through Alabama, Mississippi, and Arkansas. The top broilerproducing State is Georgia, followed by Arkansas, Alabama, North Carolina, Mississippi, and Texas. Operations in these States account for over 65 percent of broiler cash receipts.

Most U.S. broiler production is conducted under contract with broiler processors. The grower normally supplies the growout house with all the necessary heating, cooling, feeding, and watering systems. The grower also supplies the labor needed in growing the birds. The broiler processor supplies the chicks, feed, and veterinary medicines. The processor schedules transportation of the birds from the farm to the slaughter plant. In many cases, the processor also supplies the crews who place broilers into cages for transportation to the slaughter plant.

The U.S. turkey industry produces over onequarter of a billion birds annually, with the live weight of each bird averaging over 25 pounds. Production of turkeys is somewhat more scattered geographically than broiler production. The top five turkeyproducing States are Minnesota, North Carolina, Missouri, Arkansas, and Virginia. The United States is by far the world's largest turkey producer, followed by the European Union. Even though exports are a major component of the U.S. turkey industry, the United States consumes more turkey per capita than any other country.

U.S. egg operations produce over 77 billion eggs annually. Over threefourths of egg production is for human consumption (the tableegg market). The remainder of production is for the hatching market. These eggs are hatched to provide replacement birds for the egglaying flocks and broiler chicks for growout operations. The top five eggproducing States are Iowa, Ohio, Pennsylvania, Indiana, and California.\3\ \3\ USDA/ERS, Livestock, Dairy, and Poultry Outlook/LDPM158, August 20, 2007.

The United States is the world's largest exporter of poultry meat. Annual poultry meat exports totaled about 5.8 billion pounds in 2006, which is about 14.5 percent of U.S. production. (All trade statistics in this and the following
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paragraph are for 2006.) Demand for U.S. poultry meat products has fluctuated over the last several years due to changing economic conditions and currency exchange rates in major importing countries. The largest importers of U.S. broiler products are Russia, Mexico, China, Canada, Hong Kong, Turkey, Taiwan, Angola, South Korea, and Ukraine. Together, these markets accounted for over 74 percent of U.S. poultry meat exports, on a quantity basis. The United States imports only small amounts of poultry meat, accounting for less than twotenths of 1 percent of domestic production. Over 98 percent of imports come from Canada.

As in the case of poultry meat, U.S. exports of live poultry and exports of fresh shell eggs are widely distributed and significantly outweigh imports of these products. The United States exported 1.302 million eggs and imported 65.4 million eggs in 2006. The major importers of eggs are Canada, Mexico, Jamaica, United Kingdom, Hong Kong, Brazil, Trinidad and Tobago, Dominican Republic, Guyana, and Nicaragua. These countries altogether accounted for about 80 percent of U.S. egg exports. U.S. imports are mainly from Canada, China, France, and Taiwan. These countries together accounted for 91 percent of U.S. imports of eggs. The United States exported 51 million live poultry and imported 13.7 million live poultry in 2006. Major destinations include Canada, Mexico, China, Thailand, Peru, Colombia, Guatemala, Indonesia, Egypt, and El Salvador. These countries accounted for 70 percent of U.S. total live poultry exports. All U.S. imports of live poultry came from Canada, United Kingdom, and Italy.

The decision to participate in the NPIP program is voluntary. Being a participating flock in NPIP has many benefits. These include: The flock being recognized as a participating member of NPIP; the flock having an approval number which may be used on shipping labels, certificates, invoices, and other documents for identification purposes; the flock being listed in the official NPIP Directory of Participants; free listing in various State fair brochures; and receiving emergency disease management updates. Furthermore, being a participant in the NPIP allows for greater ease in moving hatching eggs and live birds within a State, across State lines, and into international markets. In fact, most countries will not accept hatching eggs, live birds, table eggs, or broilers unless they can be shown to be from a NPIP participant.

Any increased cost to NPIP participants due to the proposed rule would be minor compared to the expected benefits of the proposed program changes. Additional costs are likely to be minor because most of the participants already had been implementing these changes for several years. Even if additional tests were required, the additional number of birds tested would be very small compared to the size of flocks in the industry. Individual producers will continue to participate in the NPIP program only if the benefits they receive from participation outweigh the costs. Over 99 percent of poultry breeders and hatcheries, commercial tableegg layer flocks, and commercial meat type chicken and turkey slaughter plants are Plan participants. Impact on Small Entities

The Regulatory Flexibility Act requires that agencies consider the economic effects of their rules on small entities. According to the Small Business Administration's (SBA's) Office of Advocacy, regulations create economic disparities based on size when they have a significant economic impact on a substantial number of small entities.

Entities engaged in production of breeding stock and hatcheries would be affected by the rule. Currently there are four major firms that produce primary breeding stock of eggtype chickens, three breeders of meattype chickens, two breeders of turkeys, and one firm producing breeding stock of both eggtype and meattype chickens.\4\ All of these are large facilities headquartered in the United States that operate in domestic and international markets, and would not be considered small entities. Few, if any, small producers would be directly affected by this proposed rule.
\4\ Mary E. Delany, Genetic Diversity and Conservation of Poultry, p.261, in W.M. Muir and S.E. Aggrey, Poultry Genetics, Breeding and Biotechnology, August 2003; Susanne Gura, Livestock Genetics Companies: Concentration and Proprietary Strategies of an Emerging Power in the Global Economy (http://pastoralpeoples.org/ docs/Livestockgenetics.pdf).

Broiler operations (North American Industry Classification System [NAICS] code 112320), turkey operations (NAICS 112330), hatcheries (NAICS 112340), and other poultry operations (112390) could also be affected by the proposed changes. All of these operations are considered to be small if they have annual sales of $750,000 or less (U.S. Small Business Administration Table of Small Business Size Standards, http://www.sba.gov/idc/groups/public/documents/sba_ homepage/serv_sstd_tablepdf.pdf). Commercial egg producers (NAICS 112310) are considered small if they have annual sales of not more than $11.5 million.

The broiler industry has evolved from small backyard flocks to fewer than 50 highly specialized, vertically integrated agribusiness firms. A measure of the changing structure is the number and size of chicken hatcheries. In 1973, there were 989 facilities that hatched all chickens in the United States. Those hatcheries had the capacity to incubate 436 million eggs at one time for an average capacity of 440,849 eggs. In 2006, there were 313 chicken hatcheries, with an incubator capacity of 910 million eggs for an average capacity of 2.9 million eggs. Similarly, there were 203 turkey hatching facilities with capacity to incubate 45 million eggs at one time, for an average capacity of 221,675 eggs. In 2006, there were 55 turkey hatcheries, with an incubator capacity of 39 million eggs for an average capacity of 703,927 eggs.\5\
\5\ USDA, ERS, Hatchery Production, March 1975; Hatchery Production 2006 Summary, April 2007.

We do not foresee any significant impact of the proposed rule on small entities. The NPIP is a voluntary program, so poultry producers can decide if it is beneficial for them to participate.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.

Executive Order 12372

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are in conflict with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.

Paperwork Reduction Act

This proposed rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
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List of Subjects in 9 CFR Parts 145, 146, and 147

Animal diseases, Poultry and poultry products, Reporting and recordkeeping requirements.

Accordingly, we propose to amend 9 CFR parts 145, 146, and 147 as follows:
PART 145NATIONAL POULTRY IMPROVEMENT PLAN FOR BREEDING POULTRY

1. The authority citation for part 145 continues to read as follows:

Authority: 7 U.S.C. 83018317; 7 CFR 2.22, 2.80, and 371.4.

2. Section 145.1 is amended as follows:

a. By revising the definition of authorized laboratory to read as set forth below.

b. By adding, in alphabetical order, new definitions of NPIP Technical Committee and Senior Coordinator to read as set forth below.

c. In the definition of equivalent or equivalent requirements, by adding the words ``or exceed'' after the words ``equal to'' and the words ``they are'' after the words ``with which.''
Sec. 145.1 Definitions.

* * * * *

Authorized laboratory. An authorized laboratory is a laboratory that meets the requirements of Sec. 147.51 and is thus qualified to perform the assays described in part 147 of this subchapter. * * * * *

NPIP Technical Committee. A committee made up of technical experts on poultry health, biosecurity, surveillance, and diagnostics. The committee consists of representatives from the poultry and egg industries, universities, and State and Federal governments and is appointed by the Senior Coordinator and approved by the General Conference Committee.

* * * * *

Senior Coordinator. An employee of the Service whose duties may include, but will not necessarily be limited to:
(1) Serving as executive secretary of the General Conference Committee;
(2) Serving as chairperson of the Plan Conference described in Sec. 147.47;
(3) Planning, organizing, and conducting the Plan Conference; (4) Reviewing NPIP authorized laboratories as described in Sec. 147.51;
(5) Coordinating the State administration of the NPIP through periodic reviews of the administrative procedures of the Official State Agencies, according to the applicable provisions of the Plan and the Memorandum of Understanding;
(6) Coordinating rulemaking to incorporate the proposed changes of the provisions approved at the Plan conference into the regulations in parts 145, 146, and 147 of this subchapter;
(7) Directing the production of official NPIP publications; (8) Proposing an annual budget for plan activities and the General Conference Committee; and
(9) Providing overall administration of the NPIP.

* * * * *

3. In Sec. 145.2, paragraph (a) is amended by adding a new sentence at the end of the paragraph to read as follows:
Sec. 145.2 Administration.
(a) * * * In the Memorandum of Understanding, the Official State Agency must designate a contact representative to serve as a liaison between the Service and the Official State Agency.
* * * * *

4. Section 145.14 is amended as follows:

a. By adding a new paragraph (b)(5) to read as set forth below.

b. By revising paragraph (d) to read as set forth below. Sec. 145.14 Blood testing.
* * * * *
(b) * * *
(5) The official molecular examination procedures for Mycoplasma gallisepticum and M. synoviae are the polymerase chain reaction (PCR) test described in Sec. 147.30 of this subchapter and the realtime PCR test described in Sec. 147.31 of this subchapter.
* * * * *
(d) For avian influenza. The official tests for avian influenza are described in paragraphs (d)(1) and (d)(2) of this section.
(1) Antibody detection tests(i) Enzymelinked immunosorbent assay (ELISA). ELISA must be conducted using test kits approved by the Department and the Official State Agency and must be conducted in accordance with the recommendations of the producer or manufacturer. (ii) The agar gel immunodiffusion (AGID) test. (A) The AGID test must be conducted on all ELISApositive samples.
(B) The AGID test must be conducted using reagents approved by the Department and the Official State Agency.
(C) Standard test procedures for the AGID test for avian influenza are set forth in Sec. 147.9 of this subchapter. The test can be conducted on egg yolk or blood samples.
(D) Positive tests for the AGID must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation.
(2) Agent detection tests. Tests that detect influenza A matrix gene or protein may be performed by an authorized laboratory. Tests that determine hemagglutinin or neuraminidase subtypes may not be performed by an authorized laboratory. Samples for agent detection testing should be collected from naturally occurring flock mortality or clinically ill birds.
(i) The real time reverse transcriptase/polymerase chain reaction (RRTPCR) assay. (A) The RRTPCR tests must be conducted using reagents approved by the Department and the Official State Agency. The RRTPCR must be conducted using the National Veterinary Services Laboratories (NVSL) official protocol for RRTPCR (AVPR01510) and must be conducted by personnel who have passed an NVSL proficiency test.
(B) Positive results from the RRTPCR must be further tested by Federal Reference Laboratories using appropriate tests for confirmation.

FOR FURTHER INFORMATION CONTACT Mr. Andrew R. Rhorer, Senior Coordinator, Poultry Improvement Staff, National Poultry Improvement Plan, Veterinary Services, APHIS, USDA, 1498 Klondike Road, Suite 101, Conyers, GA 300945104; (770) 9223496.