81 FR 15652 - National Poultry Improvement Plan and Auxiliary Provisions
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service Federal Register Volume 81, Issue 57 (March 24, 2016)
Animal and Plant Health Inspection Service
Federal Register Volume 81, Issue 57 (March 24, 2016)
| Page Range | 15652-15660 | |
| FR Document | 2016-06664 |
[Federal Register Volume 81, Number 57 (Thursday, March 24, 2016)] [Proposed Rules] [Pages 15652-15660] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-06664] ======================================================================== Proposed Rules Federal Register ________________________________________________________________________ This section of the FEDERAL REGISTER contains notices to the public of the proposed issuance of rules and regulations. The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the adoption of the final rules. ======================================================================== Federal Register / Vol. 81, No. 57 / Thursday, March 24, 2016 / Proposed Rules [[Page 15652]] DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Parts 56, 145, 146, and 147 [Docket No. APHIS-2014-0101] RIN 0579-AE16 National Poultry Improvement Plan and Auxiliary Provisions AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: We are proposing to amend the National Poultry Improvement Plan (NPIP, the Plan), its auxiliary provisions, and the indemnity regulations for the control of H5 and H7 low pathogenic avian influenza to clarify participation in the NPIP and amend participation requirements, amend definitions for poultry and breeding stock, amend the approval process for new diagnostic tests, and amend laboratory inspection and testing requirements. These changes would align the regulations with international standards and make them more transparent to Animal and Plant Health Inspection Service stakeholders and the general public. The proposed changes were voted on and approved by the voting delegates at the Plan's 2014 National Plan Conference. DATES: We will consider all comments that we receive on or before May 23, 2016. ADDRESSES: You may submit comments by either of the following methods:Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0101. Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2014-0101, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737- 1238. Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2014- 0101 or in our reading room, which is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming. FOR FURTHER INFORMATION CONTACT: Dr. Denise Brinson, DVM, Director, National Poultry Improvement Plan, VS, APHIS, USDA, 1506 Klondike Road, Suite 101, Conyers, GA 30094-5104; (770) 922-3496. SUPPLEMENTARY INFORMATION: Background The National Poultry Improvement Plan (NPIP, also referred to below as ``the 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. Participation in all Plan programs is voluntary, but breeding flocks, hatcheries, and dealers must first qualify as ``U.S. Pullorum-Typhoid Clean'' as a condition for participating in the other Plan programs. 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. The regulations in 9 CFR parts 145, 146, and 147 (referred to below as the regulations) contain the provisions of the Plan. The Animal and Plant Health Inspection Service (APHIS, also referred to as ``the Service'') of the U.S. Department of Agriculture (USDA, also referred to as ``the Department'') amends these provisions from time to time to incorporate new scientific information and technologies within the Plan. In addition, the regulations in 9 CFR part 56 set out conditions for the payment of indemnity for costs associated with poultry that are infected with or exposed to H5/H7 low pathogenic avian influenza (LPAI) and provisions for a cooperative control program for the disease. The proposed amendments discussed in this document are consistent with the recommendations approved by the voting delegates to the last National Plan Conference, which was held on July 10 through 12, 2014. Participants in the National Plan Conference represented flockowners, breeders, hatcherymen, slaughter plants, poultry veterinarians, laboratory personnel, Official State Agencies from cooperating States, and other poultry industry affiliates. The proposed amendments are discussed in the order they would appear in the regulations. Description of Plan Intention The NPIP regulations in 9 CFR parts 145 and 146 contain requirements that must be observed by flocks that participate in the Plan. Currently, Sec. 145.3 details the process by which a person becomes eligible to participate in the Plan. Any person producing or dealing in products may participate when he/she has demonstrated, to the satisfaction of the Official State Agency, that his/her 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 Sec. 145.2. Affiliated flockowners may participate in the plan without signing an agreement with the Official State Agency. We are proposing to add additional language to this section to clarify that the NPIP is a cooperative Federal-State-Industry program through which new or existing diagnostic technology can be effectively applied to improve poultry and poultry products by controlling or eliminating specific poultry diseases. Because the Plan consists of programs that identify States, flocks, hatcheries, dealers, and slaughter plants that meet specific disease control standards specified in the Plan, we also propose to clarify that recordkeeping is important to demonstrate that participants adhere to the disease control programs in which they participate. We are proposing to add this language to paragraph (a) of Sec. 145.3. Revision of Records Retention Requirement for Hatchery Inspections The regulations in Sec. 145.12 contain requirements for the retention and [[Page 15653]] examination of records for all flocks maintained primarily for hatching eggs. Historically, testing records were retained at the hatchery, which allowed for examination of the records during annual inspections. However, not many commercial hatcheries currently keep testing records for their breeder flocks at the hatchery and may instead keep the records at the corporate office. Therefore, we are proposing a minor change to the regulations to specify that records for all breeder flock hatcheries must be made available for annual examination by a State inspector. This change also maintains flexibility in who must make the records available. Such people may include the hatchery manager, the quality assurance manager, the laboratory manager, the breeder manager, or the hatchery information specialist. Clarification of Official Testing Requirements for Pullorum-Typhoid, Mycoplasma gallisepticum, M. meleagridis, and M. synoviae The regulations in Sec. 145.14 contain requirements for conducting official tests for pullorum-typhoid, Mycoplasma gallisepticum, M. meleagridis, M. synoviae, and avian influenza. Paragraph (a) outlines specific testing requirements for pullorum-typhoid. Currently, paragraph (a)(5) states that the official blood test for pullorum- typhoid shall include the testing of a sample of blood from each bird in the flock, provided that, under specified conditions in Sec. Sec. 145.23, 145.33, 145.43, 145.53, and 145.63, the testing of a portion or sample of birds may be used in lieu of testing each bird. We are proposing to add Sec. Sec. 145.73, 145.83, and 145.93 to the list of sections referenced in Sec. 145.14(a)(5) as those sections are also applicable to pullorum-typhoid blood testing. Paragraph (b) outlines specific testing requirements for M. gallisepticum, M. meleagridis, and M. synoviae. Currently, official tests for M. gallisepticum, M. meleagridis, and M. synoviae include the serum plate agglutination test, the tube agglutination test, the hemagglutination inhibition (HI) test, the microhemagglutination inhibition test, the enzyme-linked immunosorbent assay, and the polymerase chain reaction (PCR)-based test. We are proposing to remove references to the tube agglutination test because that test is outdated and no longer in use. We are also proposing to remove references to the microhemagglutination test as the term microhemagglutination is an outdated term. In addition, we are proposing to remove the reference to the PCR test and replace it with the words ``molecular based test.'' This change is necessary because there are other molecular based tests in addition to the PCR test. Also, changing the language in the regulations to ``molecular based test'' allows for greater testing flexibility in the event that a better and more cost-effective or efficient molecular based test is developed in the future. Finally, while the widely accepted industry standard has been to use either the HI test or a molecular based test to confirm the positive results of serological screening tests, this requirement has not previously been included in our regulations. Therefore, we are proposing to amend the regulations to make that clarification. Requirements for Nest Clean Hatching Eggs for Breeding Turkeys In a final rule \1\ published in the Federal Register on July 9, 2014 (79 FR 38752-38768, Docket No. APHIS-2011-0101), with an effective date of August 8, 2014, we amended the regulations by, among other things, amending the requirements for participation in the Plan by multiplier egg-type breeding chickens, multiplier meat-type breeding chickens, primary egg-type breeding chickens, and primary meat-type breeding chickens to state that hatching eggs produced by the relevant flocks should be nest clean, and that they may be fumigated in accordance with part 147 or otherwise sanitized. ``Nest clean'' eggs are eggs that are collected from nests frequently to keep them clean without further processing. These changes were necessary because it has become standard practice within the industry to avoid sanitizing eggs and instead insist on nest clean eggs, which have been found to hatch better and provide a better chick than other eggs, even when they are sanitized. In addition, removing the requirement for fumigation and instead stating that hatching eggs ``may be'' fumigated or otherwise sanitized addresses changes made due to health restrictions and concerns related to staff safety, as well as aligning with changes made to the provisions for multiplier egg-type and meat-type chicken breeding flocks and primary egg-type and meat-type breeding flocks, following the 2010 NPIP Plan Conference. --------------------------------------------------------------------------- \1\ To view the final rule and related documents, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0101. --------------------------------------------------------------------------- The regulations in Sec. 145.42 outline the requirements with which turkey flocks, and the eggs and poults produced from them, must comply in order to participate in the Plan. Due to the same restrictions and concerns for staff safety for workers in the turkey industry and the same standard practice and benefits of requiring nest clean eggs, we are proposing to make the same changes to paragraph (b) of this section that were made in the July 2014 final rule for Sec. Sec. 145.22(b), 145.32(b), 145.72(b), and 145.82(b). We are also proposing to amend the definition of breeding flock in Sec. 56.1 in order to be more inclusive of both chicken and turkey flocks. Currently, the definition for breeding flock refers to 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 for the ultimate production of eggs or meat for human consumption.'' We propose to amend this definition to remove the word ``chicks'' and replace it with the word ``progeny.'' This change is also consistent with the definition of multiplier breeding flock in Sec. 145.1. Changes to U.S. M. gallisepticum Clean and U.S. M. synoviae Clean Classification for Breeding Flocks of Hobbyist and Exhibition Waterfowl, Exhibition Poultry, and Game Birds The regulations in Sec. 145.53 set out classifications for hobbyist and exhibition waterfowl, exhibition poultry, and game bird breeding flocks and products. Paragraph (c) in Sec. 145.53 sets out the U.S. M. gallisepticum Clean classification for such poultry while paragraph (d) of that section sets out the U.S. M. synoviae Clean classification for such poultry. We are proposing to require targeted bird sampling of the choanal palatine cleft/fissure area using appropriate swabs as an alternative to the random serum or egg yolk sampling currently required for retention of the U.S. M. gallisepticum Clean classification. The choanal palatine cleft/fissure area is easier to swab and is also a very reliable site for detection of M. gallisepticum and M. synoviae. The targeted sampling of this area would provide a greater likelihood of detecting the organism of concern than either the random serum or egg yolk sampling methods. We are also proposing to change the size of the sample for U.S. M. gallisepticum testing from the current 5 percent of birds in the flock to at least 30 birds, or all birds in the flock if the flock size is less than 30. We would make the same change for a multiplier breeding flock which originated as U.S. M. gallisepticum Clean baby poultry from primary breeding flocks. Currently, sampling of such flocks must consist of at least 2 percent of birds in the flock. These changes would provide for a more appropriate level of sampling for M. [[Page 15654]] gallisepticum, particularly for those flocks that contain fewer than 30 birds. Because M. gallisepticum and M. synoviae spread and infect birds similarly, we are proposing to amend the U.S. M. synoviae Clean classification to require that retention of that classification may also be obtained either by random sampling of serum or egg yolk or a targeted bird sample of the choanal palatine cleft/fissure area using appropriate swabs. Currently, the regulations do not specify how sampling is to be conducted. In addition, we are proposing to change the size of the sample for U.S. M. synoviae testing from at least 150 birds in the flock to at least 30 birds, or all birds in the flock if the flock size is less than 30. Finally, for a multiplier breeding flock which originated as U.S. M. synoviae Clean baby poultry from primary breeding flocks, we would remove the requirement for sampling a minimum of 75 birds and instead require that a random sample contain 50 percent of the birds in the flock with a maximum of 200 birds and a minimum of 30 birds, or all birds in the flock if the flock is less than 30 birds. This sampling would have to be conducted on birds that are at least 4 months of age or upon reaching sexual maturity. Assuming a normal distribution and an infection rate of 1 percent, changing the sample sizes as proposed does not greatly affect the chance of detecting a positive sample (confidence interval approximately 95 percent). These proposed sample size changes would allow us to increase the efficiency of the NPIP program by allowing resources to be used elsewhere. Changes to U.S. Salmonella Monitored Certification Requirements The regulations in Sec. 145.83 set out the requirements for the classification of participating flocks, and the eggs and chicks produced from them, with respect to certain diseases. Paragraph (f) of Sec. 145.83 sets out requirements for preventing and controlling Salmonella in the breeding-hatching industry. Currently, a flock may be designated as U.S. Salmonella Monitored when, among other things, feed used for the flock, if containing animal proteins, adheres to certain processing requirements. We are proposing to remove these requirements because we believe that the rendering industry has appropriate standards to deal with the transmission of Salmonella through poultry feed and, therefore, these requirements are not necessary in the NPIP regulations. In addition, most of the primary meat type chicken industry today does not use animal protein products in their feed due to concerns of disease transmission. Therefore, we propose to amend the regulations in paragraph (f)(1)(i) to instead state that ``measures shall be implemented to control Salmonella challenge through the feed, feed storage, and feed transport.'' We also propose to remove paragraphs (f)(1)(ii) and (f)(1)(iii) and renumber paragraphs (f)(1)(iv) through (f)(1)(viii) as paragraphs (f)(1)(ii) through (f)(1)(vi). Revision to Sanitation Requirements for Meat-Type Waterfowl The regulations in Sec. Sec. 145.91 and 145.92 set out special provisions for meat-type waterfowl and the eggs and baby poultry produced from them. Currently, paragraph (b) of Sec. 145.92 requires that hatching eggs produced by primary breeding flocks be fumigated in accordance with part 147 or otherwise sanitized. We are proposing to remove the requirement for fumigation and instead state that hatching eggs should be ``nest clean'' and that they ``may be'' fumigated or otherwise sanitized. We would also extend these requirements to multiplier breeding flocks, as these proposed requirements are meant to mirror the changes made to the provisions for multiplier egg-type and meat-type chicken breeding flocks and primary egg-type and meat-type breeding flocks, following the 2010 NPIP conference as well as the changes we are proposing to the regulations for breeding turkeys in Sec. 145.42. Revision to Sample Size for U.S. H5/H7 Avian Influenza Clean Classification The regulations in Sec. 145.93 set out requirements for the classification of participating flocks of meat-type waterfowl and the eggs and baby poultry produced from them, with respect to certain diseases. Paragraph (c) of Sec. 145.93 sets out requirements for the classification of such flocks as U.S. H5/H7 Avian Influenza Clean. Currently, the regulations state that, in order for multiplier breeding flocks to retain this classification, a sample of at least 30 birds must either be tested negative for avian influenza at intervals of 180 days, a sample of fewer than 30 birds may be tested and found negative for avian influenza at any one time if all pens are equally represented and a total of 30 birds are tested within each 180-day period, or a sample of at least 30 birds are tested and found negative to H5/H7 avian influenza within 21 days prior to movement to slaughter. In the July 2014 final rule, we amended the regulations by changing the number of breeding birds required to be tested for avian influenza prior to movement to slaughter in Sec. Sec. 145.23, 145.33, and 145.73. Rather than requiring 30 spent fowl to be tested, we now require the testing of a sample of 11 birds prior to movement to slaughter. This change was necessary because, generally, the entire flock of egg-type breeding chickens will be moved to slaughter at one time. Testing 11 birds per flock is also consistent with the testing requirements for meat-type commercial chickens moved to slaughter under the U.S. H5/H7 Avian Influenza Monitored program in Sec. 146.33, and provides adequate assurance that the flock is free of avian influenza. We are proposing to make the same change for meat-type waterfowl breeding flocks. Aligning sample numbers across similar flocks simplifies plan participation. Changes to the List of Commercial Poultry Plan Participants Part 146 of the regulations contains the NPIP provisions for commercial poultry. Section 146.3 provides requirements for participation in the Plan by commercial table-egg producers, raised- for-release upland game bird or waterfowl premises, commercial upland game bird or waterfowl slaughter plants, and meat-type chicken or turkey slaughter plants. We propose to amend the regulations to add commercial table-egg layer pullet flocks to the list of Plan participants in paragraph (c)(1) of Sec. 146.2 and paragraph (a) in Sec. 146.3. A commercial table-egg layer pullet flock is currently defined in Sec. 146.1 as a table-egg layer flock prior to the onset of egg production. The inclusion of these flock owners as Plan participants provides a means for NPIP staff to identify participation in the Plan and to help facilitate the movement of birds within States and across State lines. Finally, we are proposing to amend the definition of poultry in Sec. 146.1 to make it more inclusive of all domesticated fowl bred for the purpose of providing eggs or meat, including waterfowl and game birds. This change would be consistent with the poultry definition in Sec. 56.1 and Sec. 145.1. Amendment to Slaughter Plant Inspection Requirements Section 146.11 of the regulations sets out the audit process for participating slaughter plants. Paragraph (b) states that flocks slaughtered at a slaughter plant will be considered to be not conforming to the required protocol of the classifications 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 flocks were not returned before slaughter. We are [[Page 15655]] proposing to amend paragraph (b) to state that a flock will be considered to be conforming to protocol if it meets the requirements described in Sec. Sec. 146.33(a), 146.43(a), or 146.53(a). This change would correct problems inadvertently caused by combining all allowed testing requirements in 9 CFR part 146, subparts C, D, and E for participating slaughter plants into one set of testing requirements. One such problem was that the language in paragraph (b) directly contradicted the requirement allowing for testing at the slaughter plant on a shift basis. This change would also allow for future amendments to testing requirements for each subpart independent of one another and without having to amend the regulations in Sec. 146.11. Addition of Testing Commercial Table-Egg Producing Upland Game Birds and Waterfowl for Avian Influenza The regulations in Sec. Sec. 146.51 through 146.53 contain special provisions related to the participation in the NPIP program by commercial upland game birds, commercial waterfowl, raised-for-release upland game birds, and raised-for-release waterfowl and the classification of such flocks as U.S. H5/H7 Avian Influenza Monitored. Commercial upland game birds and waterfowl are sometimes grown for the primary purpose of producing eggs for human consumption, notably in specialty markets, restaurants, and health food outlets. Because a significant number of these flocks are large in size, we believe that the creation of a mechanism for NPIP participation and avian influenza surveillance for such flocks would be beneficial to the poultry industry as a whole. Therefore, we are proposing to amend the definition for commercial upland game birds and commercial waterfowl in Sec. 146.51 to include birds grown for egg production. Currently, the definitions for these categories of birds include only those birds grown for the primary purpose of producing meat for human consumption. We are also proposing to add commercial upland game birds and commercial waterfowl producing eggs for human consumption to the list of Plan participants in paragraphs (a) and (c) of Sec. 146.52. We would also change the word ``purpose'' under both the definition for commercial upland game birds and commercial waterfowl to ``purposes.'' Paragraph (a) of Sec. 146.53 contains the U.S. H5/H7 Avian Influenza Monitored classification for commercial waterfowl and commercial upland game birds. Currently, the commercial waterfowl and commercial upland game bird industry may earn U.S. H5/H7 Influenza Monitored classification by participating in routine surveillance for H5/H7 avian influenza through participating slaughter plants. We are proposing to add provisions for the regular surveillance of commercial waterfowl and game bird egg-producing flocks for avian influenza in new paragraphs (a)(4) and (a)(5). These provisions would require that a minimum of 11 birds per flock be tested negative to H5/H7 avian influenza as provided in Sec. 146.13 within 30 days of disposal or within a 12 month period or that the participating flock has an on- going active and passive surveillance program for H5/H7 avian influenza approved by the Official State Agency and the Service. Amendments to Authorized Laboratory Requirements Subpart F of part 147 contains provisions for authorized laboratories and approved test and sanitation procedures under the NPIP. Section 147.52 contains the current provisions for approving authorized laboratories. While these provisions currently require laboratories to undergo an annual site visit and recordkeeping audit by their Official State Agency in order to maintain authorization, laboratory procedures and personnel generally do not change on a yearly basis. In addition, the need for Official State Agencies to inspect laboratories in other States serving industry members within their own States has proven to unnecessarily consume time and travel funds best utilized in other areas of the Plan. Therefore, we are proposing to amend the regulations to require that site visits take place at least once every 2 years. Amendments to the Approval Process for New Diagnostic Tests Section 147.54 outlines the required procedures for the approval of diagnostic test kits that are not licensed by APHIS. Current paragraph (a) states that the sensitivity of the kit will be estimated by testing known positive samples, as determined by official NPIP procedures found in the NPIP program standards or via other procedures approved by the Administrator. Because it is difficult to define a minor test modification versus a major test modification and to determine what data might be needed beforehand for a new test, we are proposing to allow the conditional use of a modified test side by side with the approved versions using field samples. This would make it easier for laboratories to participate in the test validation process. Field samples would have to be composed of those samples for which the presence or absence of the target organism or analyte has been determined by the current NPIP test rather than spiked samples or pure cultures. In addition, samples would have to come from a variety of field cases representing a range of low, medium, and high analyte concentrations. Spiked samples should only be used in the event that no other sample types are available. These changes would ensure that samples used for validation represent real samples and contain the same analytes and extraneous material that would be found in clinical samples. Realistic samples are critical to ensuring that a test will perform adequately with normal use. We are also proposing to clarify that laboratories should only be selected for their experience with testing for the target organism or analyte with the current NPIP approved test. Finally, we are proposing to remove the requirement that authorized laboratories be selected by the Service and clarify that the specificity of the kit will be ``evaluated'' rather than ``estimated'' in both current paragraphs (a) and (b) to provide more specific information on test performance. We are proposing this change because authorized NPIP laboratories use the same standards and guidelines. Therefore, any NPIP-authorized laboratory should be able to be utilized by any company seeking approval of a new test. We are also proposing to revise the regulations in current paragraph (c) to remove the requirement for clinical samples to be supplied by the manufacturer of the test kit. Further, we propose to require that at least 50 known negative samples be tested by each laboratory rather than the currently required 50 known negative clinical samples. Because it can be difficult to find clinical samples and to share clinical samples for logistical reasons, removing the requirements for clinical samples and for samples to be supplied by the test kit manufacturer would allow any entity to provide clinical samples. However, the negative samples would have to contain relevant sample matrices/extraneous material which would be found in clinical samples. In addition, requiring at least 50 known negative samples rather than 50 known negative samples is necessary because, in the past, we have received fewer than 50 samples from a company when more samples were unavailable. This change would make it clearer that we view any sample sets consisting of fewer than 50 samples as incomplete and that we [[Page 15656]] would not review such sample sets. We are also proposing to add language allowing cooperating laboratories to perform a current NPIP procedure or test on samples alongside the test kit for comparison, and specific testing procedures for Salmonella, Mycoplasma, and avian influenza, as well as molecular-based testing procedures to better account for the differences among the three agents. Paragraph (d) states that laboratories must submit assay response data to the kit manufacturer along with the official NPIP procedure. We are proposing to require that a worksheet for diagnostic test evaluation be submitted along with the raw data from the assay response and that the data and completed worksheet be submitted to the NPIP Senior Coordinator 4 months before the next General Conference Committee meeting, which is when test approval would be sought. Worksheets would be obtained by contacting the NPIP Senior Coordinator. The diagnostic test evaluation worksheet is intended to provide a standardized template to ensure that all needed data for test evaluation has been prepared and that the data is available in a uniform manner. This would make review of the data easier for the NPIP Technical Committee, which would facilitate the test approval process. Paragraph (e) puts forth the process by which the NPIP Technical Committee will make their decision about whether to approve a new diagnostic test. We propose to clarify that a majority of the members of the Technical Committee would have to recommend whether to approve the test kit and that this recommendation would have to occur at the next scheduled General Conference Committee meeting. Currently, the regulations do not provide procedures for modifying or removing diagnostic tests. Therefore, we are proposing to redesignate the introductory paragraph for Sec. 147.54 as paragraph (a) and the following paragraphs (a) through (f) as paragraphs (a)(1) through (6) and add a new paragraph (b) to describe how diagnostic tests may be modified or removed. The proposed requirements would require the submission of data in support of modifying or removing the test in question to the NPIP Technical Committee in a manner similar to that in place for the approval of new test kits in current paragraph (e). Executive Order 12866 and Regulatory Flexibility Act This proposed 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. In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available by contacting the person listed under FOR FURTHER INFORMATION CONTACT or on the Regulations.gov Web site (see ADDRESSES above for instructions for accessing Regulations.gov). The changes in this proposed rule are recommended by the NPIP General Conference Committee, which represents cooperating State agencies and poultry industry members and advises the Secretary of Agriculture on issues pertaining to poultry health. The proposed amendments to these regulations would improve the regulatory environment for poultry and poultry products. This rulemaking would result in various changes to 9 CFR parts 56 and 145-147, modifying provisions of the NPIP. The proposed rule would clarify participation in the NPIP and amend participation requirements, amend definitions for poultry and breeding stock, amend the approval process for new diagnostic tests, and amend inspection and laboratory testing requirements. The proposed amendments to these regulations would improve the regulatory environment for poultry and poultry products. The establishments that would be affected by the proposed rule-- principally entities engaged in poultry production and processing--are predominantly small by Small Business Administration standards. In those instances in which an addition or modification could potentially result in a cost to certain entities, we do not expect the costs to be significant. This rule embodies changes decided upon by the NPIP General Conference Committee on behalf of Plan members, that is, changes recognized by the poultry industry as in their interest. We note that NPIP membership is voluntary. 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 2 CFR chapter IV.) Paperwork Reduction Act In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB). Please send written comments to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503. Please state that your comments refer to Docket No. APHIS- 2014-0101. Please send a copy of your comments to: (1) APHIS, using one of the methods described under ADDRESSES at the beginning of this document, and (2) Clearance Officer, OCIO, USDA, Room 404-W, 14th Street and Independence Avenue SW., Washington, DC 20250. A comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication of this proposed rule. We are proposing to amend the NPIP, its auxiliary provisions, and the indemnity regulations for the control of H5 and H7 low pathogenic avian influenza to clarify participation in the NPIP and amend participation requirements, amend definitions for poultry and breeding stock, amend the approval process for new diagnostic tests, and amend laboratory inspection and testing requirements. These changes would align the regulations with international standards and make them more transparent to APHIS stakeholders and the general public. Implementing this rule will require certain new information collection activities such as Waterfowl and Game Bird Surveillance and Diagnostic Test Evaluation Worksheets. APHIS is asking OMB to approve, for 3 years, its use of these information collection activities in connection with APHIS' efforts to continually improve the health of the U.S. poultry population and the quality of U.S. poultry products. The NPIP has an existing information collection under OMB control number 0579-0007. At the next renewal of 0579-0007, we will merge the activities added by this proposed rule, subject to OMB approval. We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us: (1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility; [[Page 15657]] (2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses). Estimate of burden: Public reporting burden for this collection of information is estimated to average 1.8 hours per response. Respondents: Flock owners, breeders, hatchery owners, table egg producers, laboratory personnel, and State animal health officials. Estimated annual number of respondents: 10. Estimated annual number of responses per respondent: 1. Estimated annual number of responses: 10. Estimated total annual burden on respondents: 18 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.) Copies of this information collection can be obtained from Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727. E-Government Act Compliance The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727. List of Subjects 9 CFR Part 56 Animal diseases, Indemnity payments, Low pathogenic avian influenza, Poultry. 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 56, 145, 146, and 147 as follows: PART 56--CONTROL OF H5/H7 LOW PATHOGENIC AVIAN INFLUENZA 0 1. The authority citation for part 56 continues to read as follows: Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4. 0 2. Section 56.1 is amended by revising the definition of breeding flock to read as follows: Sec. 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 progeny for the ultimate production of eggs or meat for human consumption. * * * * * PART 145--NATIONAL POULTRY IMPROVEMENT PLAN FOR BREEDING POULTRY 0 3. The authority citation for part 145 continues to read as follows: Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4. Sec. 145.2 [Amended] 0 4. In Sec. 145.2, paragraph (d) is amended by removing the words ``Sec. 145.3(d)'' and adding the words ``Sec. 145.3(e)'' in their place. 0 5. Section 145.3 is amended as follows: 0 a. By redesignating paragraphs (a) through (f) as paragraphs (b) through (g), respectively. 0 b. By adding a new paragraph (a). The addition reads as follows: Sec. 145.3 Participation. (a) The National Poultry Improvement Plan is a cooperative Federal- State-Industry program through which new or existing diagnostic technology can be effectively applied to improve poultry and poultry products by controlling or eliminating specific poultry diseases. The Plan consists of programs that identify States, flocks, hatcheries, dealers, and slaughter plants that meet specific disease control standards specified in the Plan. Participants shall maintain records to demonstrate that they adhere to the disease control programs in which they participate. * * * * * Sec. 145.12 [Amended] 0 6. Section 145.12 is amended by adding, in paragraph (b), the words ``made available to and'' before the word ``examined''. 0 7. Section 145.14 is amended as follows: 0 a. By revising paragraph (a)(5). 0 b. By revising paragraph (b)(1). The revisions read as follows: Sec. 145.14 Testing. * * * * * (a) * * * (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 Sec. Sec. 145.23, 145.33, 145.43, 145.53, 145.63, 145.73, 145.83, and 145.93) the testing of a portion or sample of the birds may be used in lieu of testing each bird. * * * * * (b) * * * (1) The official tests for M. gallisepticum, M. meleagridis, and M. synoviae shall be the serum plate agglutination test, the hemagglutination inhibition (HI) test, the enzyme-linked immunosorbent assay (ELISA) test \3\, or a molecular based test. The HI test or molecular based test shall be used to confirm the positive results of other serological screening 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 this paragraph (b) and in accordance with part 147 of this subchapter. * * * * * \3\ Procedures for the enzyme-linked immunosorbent assay (ELISA) test are set forth in the following publications: A.A. Ansari, R.F. Taylor, T.S. Chang, ``Application of Enzyme-Linked Immunosorbent Assay for Detecting Antibody to Mycoplasma gallisepticum Infections in Poultry,'' Avian Diseases, Vol. 27, No. 1, pp. 21-35, January-March 1983; and H.M. Opitz, J.B. Duplessis, and M.J. Cyr, ``Indirect Micro-Enzyme- Linked Immunosorbent Assay for the Detection of Antibodies to Mycoplasma synoviae and M. gallisepticum,'' Avian Diseases, Vol. 27, No. 3, pp. 773-786, July-September 1983; and H.B. Ortmayer and R. Yamamoto, ``Mycoplasma Meleagridis Antibody Detection by Enzyme-Linked Immunosorbent Assay (ELISA),'' Proceedings, 30th Western Poultry Disease Conference, pp. 63-66, March 1981. 0 8. In Sec. 145.42, paragraph (b) is revised to read as follows: [[Page 15658]] Sec. 145.42 Participation. * * * * * (b) Hatching eggs should be nest clean. They may be fumigated in accordance with part 147 of this subchapter or otherwise sanitized. * * * * * 0 9. Section 145.53 is amended as follows: 0 a. By revising paragraphs (c)(1)(i), (c)(1)(ii) introductory text, and (c)(1)(ii)(A). 0 b. By revising paragraphs (d)(1)(i), (d)(1)(ii) introductory text, and (d)(1)(ii)(A). The revisions read as follows: Sec. 145.53 Terminology and classification; flocks and products. * * * * * (c) * * * (1) * * * (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 Sec. 145.14(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 all the birds in the flock if the 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 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 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 the flock size is less than 30 birds, has been tested for M. gallisepticum as provided in Sec. 145.14(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 all the birds in the flock if flock size is less than 30, but at least 30 birds, shall be tested; or * * * * * (d) * * * (1) * * * (i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. synoviae as provided in Sec. 145.14(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 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 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 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 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 the flock is less than 30 birds, has been tested for M. synoviae as provided in Sec. 145.14(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 palantine cleft/ fissure area using appropriate swabs from all the birds in the flock if the flock size is less than 30, but at least 30 birds shall be tested: Provided, That a sample of fewer 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 total of at least 30 birds, or the entire flock if flock size is less than 30, is tested each time and a total of at least 30 birds is tested within each 90-day period; or * * * * * 0 10. Section 145.83 is amended as follows: 0 a. By revising paragraph (f)(1)(i). 0 b. By removing paragraphs (f)(1)(ii) and (f)(1)(iii). 0 c. By redesignating paragraphs (f)(1)(iv) through (f)(1)(viii) as paragraphs (f)(1)(ii) through (f)(1)(vi). 0 d. In newly redesignated paragraphs (f)(1)(v) and (f)(1)(vi) by removing the words ``(f)(1)(vi)'' and adding the words ``(f)(1)(iv)'' in their place. 0 e. By revising paragraph (f)(3). The revisions read as follows: Sec. 145.83 Terminology and classification; flocks and products. * * * * * (f) * * * (1) * * * (i) Measures shall be implemented to control Salmonella challenge through feed, feed storage, and feed transport. * * * * * (3) In order for a hatchery to sell products of paragraphs (f)(1)(i) through (f)(1)(vi) of this section, all products handled shall meet the requirements of the classification. * * * * * 0 11. In Sec. 145.92, paragraph (b) is revised to read as follows: Sec. 145.92 Participation. * * * * * (b) Hatching eggs produced by primary and multiplier breeding flocks should be nest clean. They may be fumigated in accordance with part 147 of this subchapter or otherwise sanitized. * * * * * Sec. 145.93 [Amended] 0 12. In Sec. 145.93, paragraph (c)(3) is amended by removing the number ``30'' and adding the number ``11'' in its place. PART 146--NATIONAL POULTRY IMPROVEMENT PLAN FOR COMMERCIAL POULTRY 0 13. The authority citation for part 146 continues to read as follows: Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4. 0 14. Section 146.1 is amended by revising the definition of poultry to read as follows: Sec. 146.1 Definitions. * * * * * Poultry. Domesticated fowl, including chickens, turkeys, waterfowl, and game birds, except doves and pigeons, that are bred for the primary purpose of producing eggs or meat. * * * * * 0 15. Section 146.2 is amended by revising paragraph (c) to read as follows: Sec. 146.2 Administration. * * * * * (c)(1) An Official State Agency may accept for participation a commercial table-egg layer pullet flock, commercial table-egg layer flock, or a commercial meat-type flock (including an affiliated flock) located in another participating State under a mutual understanding and [[Page 15659]] agreement, in writing, between the two Official State Agencies regarding conditions of participation and supervision. (2) An Official State Agency may accept for participation a commercial table-egg layer pullet flock, commercial table-egg layer flock, or a commercial meat-type flock (including an affiliated flock) located in a State that does not participate in the Plan under a mutual understanding and agreement, in writing, between the owner of the flock and the Official State Agency regarding conditions of participation and supervision. * * * * * Sec. 146.3 [Amended] 0 16. In Sec. 146.3, paragraph (a) is amended by adding the words ``commercial table-egg layer pullet flock,'' before the words ``table- egg producer''. 0 17. In Sec. 146.11, paragraph (b) is revised to read as follows: Sec. 146.11 Inspections. * * * * * (b) A flock will be considered to be conforming to protocol if it meets the requirements as described in Sec. 145.33(a), Sec. 146.43(a), or Sec. 146.53(a) of this chapter. * * * * * Sec. 146.51 [Amended] 0 18. Section 146.51 is amended as follows: 0 a. In the definition of commercial upland game birds by changing the word ``purpose'' to ``purposes'' and adding the words ``eggs and/or'' before the word ``meat''. 0 b. In the definition of commercial waterfowl, by changing the word ``purpose'' to ``purposes'' and adding the words ``eggs and/or'' before the word ``meat''. 0 19. Section 146.52 is amended by revising paragraphs (a) and (c) to read as follows: Sec. 146.52 Participation. (a) Participating commercial upland game bird slaughter plants, commercial waterfowl slaughter plants, raised-for-release upland game bird premises, raised-for-release waterfowl premises, and commercial upland game bird and commercial waterfowl producing eggs for human consumption premises shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart E. * * * * * (c) Raised-for-release upland game bird premises, raised-for- release waterfowl premises, and commercial upland game bird and commercial waterfowl producing eggs for human consumption premises that raise fewer than 25,000 birds annually are exempt from the special provisions of this subpart E. 0 20. Section 146.53 is amended as follows: 0 a. In paragraph (a) introductory text, by adding the words ``or, in the case of egg-producing flocks, the regular surveillance of these flocks'' after the words ``participating slaughter plant''. 0 b. By adding paragraphs (a)(4) and (a)(5). The additions read as follows: Sec. 146.53 Terminology and classification; slaughter plants and premises. * * * * * (a) * * * (4) It is a commercial upland game bird or waterfowl flock that produces eggs for human consumption where a minimum of 11 birds per flock have been tested negative to the H5/H7 subtypes of avian influenza as provided in Sec. 146.13 (b) within 30 days of disposal or within a 12 month period. (5) It is a commercial upland game bird or waterfowl flock that has an on-going active and passive surveillance program for H5/H7 subtypes of avian influenza that is approved by the Official State Agency and the Service. * * * * * PART 147--AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN 0 21. The authority citation for part 147 continues to read as follows: Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4. 0 22. In Sec. 147.52, paragraph (d) is revised to read as follows: Sec. 147.52 Authorized laboratories. * * * * * (d) State site visit. The Official State Agency will conduct a site visit and recordkeeping audit at least once every 2 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. * * * * * 0 23. Section 147.54 is revised to read as follows: Sec. 147.54 Approval of diagnostic test kits not licensed by the Service. (a) Diagnostic test kits that are not licensed by the Service (e.g., bacteriological culturing kits) may be approved through the following procedure: (1) The sensitivity of the kit will be evaluated in at least three NPIP authorized laboratories 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. Field 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 from a variety of field cases representing a range of low, medium, and high 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, laboratories 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. (2) The specificity of the kit will be evaluated in at least three NPIP authorized laboratories 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 Sec. 147.53(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. (3) 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 samples. In addition, each laboratory will be asked to test at least 50 known negative samples obtained from several sources, to provide a representative sampling of the general population. The cooperating laboratories must perform a current NPIP procedure or NPIP approved test on the samples alongside the test kit for comparison. (4) Cooperating laboratories will submit to the kit manufacturer all raw data regarding the assay response. Each [[Page 15660]] 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 Senior Coordinator. Raw data and the completed worksheet for diagnostic test evaluation must be submitted to the NPIP Senior Coordinator 4 months prior to the next scheduled General Conference Committee meeting, which is when approval will be sought. (5) The findings of the cooperating laboratories will be evaluated by the NPIP Technical Committee, and the Technical Committee will make a majority recommendation whether to approve the test kit to the General Conference Committee at the next scheduled General Conference Committee meeting. If the Technical Committee recommends approval, the final approval will be granted in accordance with the procedures described in Sec. Sec. 147.46, 147.47, and 147.48. (6) 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. (b) Approved tests modification and removal. (1) The specific data required for modifications of previously approved tests will be taken on a case-by-case basis by the technical committee. (2) 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. (3) Approved diagnostic tests may be removed from the Plan by submission of a proposed change from a participant, Official State Agency, the Department, or other interested person or industry organization. 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 majority recommendation whether to remove the test kit to the General Conference Committee at the next scheduled General Conference Committee meeting. If the Technical Committee recommends removal, the final decision to remove the test will be granted in accordance with the procedures described in Sec. Sec. 147.46, 147.47, and 147.48. Done in Washington, DC, this 18th day of March 2016. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2016-06664 Filed 3-23-16; 8:45 am] BILLING CODE 3410-34-P
![15652
Proposed Rules Federal Register
Vol. 81, No. 57
Thursday, March 24, 2016
This section of the FEDERAL REGISTER may be viewed at http:// The proposed amendments discussed
contains notices to the public of the proposed www.regulations.gov/ in this document are consistent with the
issuance of rules and regulations. The #!docketDetail;D=APHIS-2014-0101 or recommendations approved by the
purpose of these notices is to give interested in our reading room, which is located in voting delegates to the last National
persons an opportunity to participate in the room 1141 of the USDA South Building, Plan Conference, which was held on
rule making prior to the adoption of the final
rules.
14th Street and Independence Avenue July 10 through 12, 2014. Participants in
SW., Washington, DC. Normal reading the National Plan Conference
room hours are 8 a.m. to 4:30 p.m., represented flockowners, breeders,
DEPARTMENT OF AGRICULTURE Monday through Friday, except hatcherymen, slaughter plants, poultry
holidays. To be sure someone is there to veterinarians, laboratory personnel,
Animal and Plant Health Inspection help you, please call (202) 799–7039 Official State Agencies from cooperating
Service before coming. States, and other poultry industry
FOR FURTHER INFORMATION CONTACT: Dr. affiliates. The proposed amendments are
9 CFR Parts 56, 145, 146, and 147 Denise Brinson, DVM, Director, discussed in the order they would
National Poultry Improvement Plan, VS, appear in the regulations.
[Docket No. APHIS–2014–0101]
APHIS, USDA, 1506 Klondike Road, Description of Plan Intention
RIN 0579–AE16 Suite 101, Conyers, GA 30094–5104;
(770) 922–3496. The NPIP regulations in 9 CFR parts
National Poultry Improvement Plan and SUPPLEMENTARY INFORMATION: 145 and 146 contain requirements that
Auxiliary Provisions must be observed by flocks that
Background participate in the Plan. Currently,
AGENCY: Animal and Plant Health
The National Poultry Improvement § 145.3 details the process by which a
Inspection Service, USDA.
Plan (NPIP, also referred to below as person becomes eligible to participate in
ACTION: Proposed rule. the Plan. Any person producing or
‘‘the Plan’’) is a cooperative Federal-
SUMMARY: We are proposing to amend State-industry mechanism for dealing in products may participate
the National Poultry Improvement Plan controlling certain poultry diseases. The when he/she has demonstrated, to the
(NPIP, the Plan), its auxiliary Plan consists of a variety of programs satisfaction of the Official State Agency,
provisions, and the indemnity intended to prevent and control poultry that his/her facilities, personnel, and
regulations for the control of H5 and H7 diseases. Participation in all Plan practices are adequate for carrying out
low pathogenic avian influenza to programs is voluntary, but breeding the applicable provisions of the Plan,
clarify participation in the NPIP and flocks, hatcheries, and dealers must first and has signed an agreement with the
amend participation requirements, qualify as ‘‘U.S. Pullorum-Typhoid Official State Agency to comply with
amend definitions for poultry and Clean’’ as a condition for participating the general and the applicable specific
breeding stock, amend the approval in the other Plan programs. provisions of the Plan and any
process for new diagnostic tests, and The Plan identifies States, flocks, regulations of the Official State Agency
amend laboratory inspection and testing hatcheries, dealers, and slaughter plants under § 145.2. Affiliated flockowners
requirements. These changes would that meet certain disease control may participate in the plan without
align the regulations with international standards specified in the Plan’s various signing an agreement with the Official
standards and make them more programs. As a result, customers can State Agency. We are proposing to add
transparent to Animal and Plant Health buy poultry that has tested clean of additional language to this section to
Inspection Service stakeholders and the certain diseases or that has been clarify that the NPIP is a cooperative
general public. The proposed changes produced under disease-prevention Federal-State-Industry program through
were voted on and approved by the conditions. which new or existing diagnostic
voting delegates at the Plan’s 2014 The regulations in 9 CFR parts 145, technology can be effectively applied to
National Plan Conference. 146, and 147 (referred to below as the improve poultry and poultry products
regulations) contain the provisions of by controlling or eliminating specific
DATES: We will consider all comments
the Plan. The Animal and Plant Health poultry diseases. Because the Plan
that we receive on or before May 23, Inspection Service (APHIS, also referred consists of programs that identify States,
2016. to as ‘‘the Service’’) of the U.S. flocks, hatcheries, dealers, and slaughter
ADDRESSES: You may submit comments Department of Agriculture (USDA, also plants that meet specific disease control
by either of the following methods: referred to as ‘‘the Department’’) amends standards specified in the Plan, we also
• Federal eRulemaking Portal: Go to these provisions from time to time to propose to clarify that recordkeeping is
http://www.regulations.gov/ incorporate new scientific information important to demonstrate that
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
#!docketDetail;D=APHIS-2014-0101. and technologies within the Plan. In participants adhere to the disease
• Postal Mail/Commercial Delivery: addition, the regulations in 9 CFR part control programs in which they
Send your comment to Docket No. 56 set out conditions for the payment of participate. We are proposing to add
APHIS–2014–0101, Regulatory Analysis indemnity for costs associated with this language to paragraph (a) of § 145.3.
and Development, PPD, APHIS, Station poultry that are infected with or
Revision of Records Retention
3A–03.8, 4700 River Road Unit 118, exposed to H5/H7 low pathogenic avian
Requirement for Hatchery Inspections
Riverdale, MD 20737–1238. influenza (LPAI) and provisions for a
Supporting documents and any cooperative control program for the The regulations in § 145.12 contain
comments we receive on this docket disease. requirements for the retention and
VerDate Sep<11>2014 16:56 Mar 23, 2016 Jkt 238001 PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 E:\FR\FM\24MRP1.SGM 24MRP1](https://thefederalregister.org/doc/81_FR_15709/page/1.svg)
![Federal Register / Vol. 81, No. 57 / Thursday, March 24, 2016 / Proposed Rules 15657
(2) Evaluate the accuracy of our Accordingly, we propose to amend 9 ‘‘made available to and’’ before the word
estimate of the burden of the proposed CFR parts 56, 145, 146, and 147 as ‘‘examined’’.
information collection, including the follows: ■ 7. Section 145.14 is amended as
validity of the methodology and follows:
assumptions used; PART 56—CONTROL OF H5/H7 LOW ■ a. By revising paragraph (a)(5).
(3) Enhance the quality, utility, and PATHOGENIC AVIAN INFLUENZA ■ b. By revising paragraph (b)(1).
clarity of the information to be The revisions read as follows:
■ 1. The authority citation for part 56
collected; and
continues to read as follows: § 145.14 Testing.
(4) Minimize the burden of the
Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22, * * * * *
information collection on those who are
2.80, and 371.4. (a) * * *
to respond (such as through the use of
(5) The official blood test shall
appropriate automated, electronic, ■ 2. Section 56.1 is amended by revising
include the testing of a sample of blood
mechanical, or other technological the definition of breeding flock to read
from each bird in the flock: Provided,
collection techniques or other forms of as follows:
That under specified conditions (see
information technology; e.g., permitting
§ 56.1 Definitions. applicable provisions of §§ 145.23,
electronic submission of responses).
* * * * * 145.33, 145.43, 145.53, 145.63, 145.73,
Estimate of burden: Public reporting 145.83, and 145.93) the testing of a
burden for this collection of information Breeding flock. A flock that is
composed of stock that has been portion or sample of the birds may be
is estimated to average 1.8 hours per used in lieu of testing each bird.
response. developed for commercial egg or meat
production and is maintained for the * * * * *
Respondents: Flock owners, breeders,
principal purpose of producing progeny (b) * * *
hatchery owners, table egg producers,
for the ultimate production of eggs or (1) The official tests for M.
laboratory personnel, and State animal
meat for human consumption. gallisepticum, M. meleagridis, and M.
health officials.
* * * * * synoviae shall be the serum plate
Estimated annual number of agglutination test, the hemagglutination
respondents: 10. inhibition (HI) test, the enzyme-linked
PART 145—NATIONAL POULTRY
Estimated annual number of IMPROVEMENT PLAN FOR BREEDING immunosorbent assay (ELISA) test 3, or
responses per respondent: 1. POULTRY a molecular based test. The HI test or
Estimated annual number of molecular based test shall be used to
responses: 10. ■ 3. The authority citation for part 145 confirm the positive results of other
Estimated total annual burden on continues to read as follows: serological screening tests. HI titers of
respondents: 18 hours. (Due to Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22, 1:40 or more may be interpreted as
averaging, the total annual burden hours 2.80, and 371.4. suspicious, and final judgment must be
may not equal the product of the annual based on further samplings and/or
number of responses multiplied by the § 145.2 [Amended]
culture of reactors. Tests must be
reporting burden per response.) ■ 4. In § 145.2, paragraph (d) is conducted in accordance with this
Copies of this information collection amended by removing the words paragraph (b) and in accordance with
can be obtained from Ms. Kimberly ‘‘§ 145.3(d)’’ and adding the words part 147 of this subchapter.
Hardy, APHIS’ Information Collection ‘‘§ 145.3(e)’’ in their place.
■ 5. Section 145.3 is amended as
* * * * *
Coordinator, at (301) 851–2727. 3 Procedures for the enzyme-linked
follows:
E-Government Act Compliance ■ a. By redesignating paragraphs (a)
immunosorbent assay (ELISA) test are
through (f) as paragraphs (b) through (g), set forth in the following publications:
The Animal and Plant Health
respectively. A.A. Ansari, R.F. Taylor, T.S. Chang,
Inspection Service is committed to
■ b. By adding a new paragraph (a). ‘‘Application of Enzyme-Linked
compliance with the E-Government Act
The addition reads as follows: Immunosorbent Assay for Detecting
to promote the use of the Internet and
Antibody to Mycoplasma
other information technologies, to § 145.3 Participation. gallisepticum Infections in
provide increased opportunities for
(a) The National Poultry Improvement Poultry,’’ Avian Diseases, Vol. 27,
citizen access to Government
Plan is a cooperative Federal-State- No. 1, pp. 21–35, January-March
information and services, and for other
Industry program through which new or 1983; and
purposes. For information pertinent to
existing diagnostic technology can be H.M. Opitz, J.B. Duplessis, and M.J. Cyr,
E-Government Act compliance related
effectively applied to improve poultry ‘‘Indirect Micro-Enzyme-Linked
to this proposed rule, please contact Ms.
and poultry products by controlling or Immunosorbent Assay for the
Kimberly Hardy, APHIS’ Information
eliminating specific poultry diseases. Detection of Antibodies to
Collection Coordinator, at (301) 851–
The Plan consists of programs that Mycoplasma synoviae and M.
2727.
identify States, flocks, hatcheries, gallisepticum,’’ Avian Diseases,
List of Subjects dealers, and slaughter plants that meet Vol. 27, No. 3, pp. 773–786, July-
specific disease control standards September 1983; and
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
9 CFR Part 56
specified in the Plan. Participants shall H.B. Ortmayer and R. Yamamoto,
Animal diseases, Indemnity maintain records to demonstrate that ‘‘Mycoplasma Meleagridis Antibody
payments, Low pathogenic avian they adhere to the disease control Detection by Enzyme-Linked
influenza, Poultry. programs in which they participate. Immunosorbent Assay (ELISA),’’
* * * * * Proceedings, 30th Western Poultry
9 CFR Parts 145, 146, and 147
Disease Conference, pp. 63–66,
Animal diseases, Poultry and poultry § 145.12 [Amended] March 1981.
products, Reporting and recordkeeping ■ 6. Section 145.12 is amended by ■ 8. In § 145.42, paragraph (b) is revised
requirements. adding, in paragraph (b), the words to read as follows:
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![15658 Federal Register / Vol. 81, No. 57 / Thursday, March 24, 2016 / Proposed Rules
§ 145.42 Participation. (d) * * * ■ e. By revising paragraph (f)(3).
* * * * * (1) * * * The revisions read as follows:
(b) Hatching eggs should be nest (i) It is a flock in which all birds or
§ 145.83 Terminology and classification;
clean. They may be fumigated in a sample of at least 300 birds has been
flocks and products.
accordance with part 147 of this tested for M. synoviae as provided in
subchapter or otherwise sanitized. § 145.14(b) when more than 4 months of * * * * *
age or upon reaching sexual maturity: (f) * * *
* * * * * (1) * * *
■ 9. Section 145.53 is amended as Provided, That to retain this
(i) Measures shall be implemented to
follows: classification, a random sample of
control Salmonella challenge through
■ a. By revising paragraphs (c)(1)(i), serum or egg yolk or a targeted bird
feed, feed storage, and feed transport.
(c)(1)(ii) introductory text, and sample of the choanal palatine cleft/
fissure area using appropriate swabs * * * * *
(c)(1)(ii)(A). (3) In order for a hatchery to sell
■ b. By revising paragraphs (d)(1)(i), (C.P. swabs) from all the birds in the
flock if flock size is less than 30, but at products of paragraphs (f)(1)(i) through
(d)(1)(ii) introductory text, and (f)(1)(vi) of this section, all products
(d)(1)(ii)(A). least 30 birds, shall be tested at intervals
of not more than 90 days: And provided handled shall meet the requirements of
The revisions read as follows: the classification.
further, That a sample comprised of less
§ 145.53 Terminology and classification; than 30 birds may be tested at any one * * * * *
flocks and products. time with the approval of the Official ■ 11. In § 145.92, paragraph (b) is
* * * * * State Agency and the concurrence of the revised to read as follows:
(c) * * * Service, provided that a total of at least
§ 145.92 Participation.
(1) * * * 30 birds is tested within each 90-day
(i) It is a flock in which all birds or period; or * * * * *
a sample of at least 300 birds has been (ii) It is a multiplier breeding flock (b) Hatching eggs produced by
tested for M. gallisepticum as provided that originated as U.S. M. Synoviae primary and multiplier breeding flocks
in § 145.14(b) when more than 4 months Clean chicks from primary breeding should be nest clean. They may be
of age or upon reaching sexual maturity: flocks and from which a random sample fumigated in accordance with part 147
Provided, That to retain this comprised of 50 percent of the birds in of this subchapter or otherwise
classification, a random sample of the flock, with a maximum of 200 birds sanitized.
serum or egg yolk or a targeted bird and a minimum of 30 birds per flock or * * * * *
sample of the choanal palatine cleft/ all birds in the flock if the flock is less § 145.93 [Amended]
fissure area using appropriate swabs than 30 birds, has been tested for M.
from all the birds in the flock if the flock synoviae as provided in § 145.14(b) ■ 12. In § 145.93, paragraph (c)(3) is
size is less than 30, but at least 30 birds, when more than 4 months of age or amended by removing the number ‘‘30’’
shall be tested at intervals of not more upon reaching sexual maturity: and adding the number ‘‘11’’ in its
than 90 days: And provided further, Provided, That to retain this place.
That a sample comprised of less than 30 classification, the flock shall be PART 146—NATIONAL POULTRY
birds may be tested at any one time, subjected to one of the following IMPROVEMENT PLAN FOR
with the approval of the Official State procedures: COMMERCIAL POULTRY
Agency and the concurrence of the (A) At intervals of not more than 90
Service, provided that a total of at least days, a random sample of serum or egg ■ 13. The authority citation for part 146
30 birds, or all birds in the flock if flock yolk or a targeted bird sample of the continues to read as follows:
size is less than 30, is tested within each choanal palantine cleft/fissure area Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22,
90-day period; or using appropriate swabs from all the 2.80, and 371.4.
(ii) It is a multiplier breeding flock birds in the flock if the flock size is less
■ 14. Section 146.1 is amended by
which originated as U.S. M. than 30, but at least 30 birds shall be
revising the definition of poultry to read
Gallisepticum Clean baby poultry from tested: Provided, That a sample of fewer
as follows:
primary breeding flocks and a random than 30 birds may be tested at any one
sample comprised of 50 percent of the time with the approval of the Official § 146.1 Definitions.
birds in the flock, with a maximum of State Agency and the concurrence of the * * * * *
200 birds and a minimum of 30 birds Service, provided that a total of at least Poultry. Domesticated fowl, including
per flock or all birds in the flock if the 30 birds, or the entire flock if flock size chickens, turkeys, waterfowl, and game
flock size is less than 30 birds, has been is less than 30, is tested each time and birds, except doves and pigeons, that are
tested for M. gallisepticum as provided a total of at least 30 birds is tested bred for the primary purpose of
in § 145.14(b) when more than 4 months within each 90-day period; or producing eggs or meat.
of age or upon reaching sexual maturity: * * * * * * * * * *
Provided, That to retain this ■ 10. Section 145.83 is amended as ■ 15. Section 146.2 is amended by
classification, the flock shall be follows: revising paragraph (c) to read as follows:
subjected to one of the following ■ a. By revising paragraph (f)(1)(i).
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
procedures: ■ b. By removing paragraphs (f)(1)(ii) § 146.2 Administration.
(A) At intervals of not more than 90 and (f)(1)(iii). * * * * *
days, a random sample of serum or egg ■ c. By redesignating paragraphs (c)(1) An Official State Agency may
yolk or a targeted bird sample of the (f)(1)(iv) through (f)(1)(viii) as accept for participation a commercial
choanal palatine cleft/fissure area using paragraphs (f)(1)(ii) through (f)(1)(vi). table-egg layer pullet flock, commercial
appropriate swabs from all the birds in ■ d. In newly redesignated paragraphs table-egg layer flock, or a commercial
the flock if flock size is less than 30, but (f)(1)(v) and (f)(1)(vi) by removing the meat-type flock (including an affiliated
at least 30 birds, shall be tested; or words ‘‘(f)(1)(vi)’’ and adding the words flock) located in another participating
* * * * * ‘‘(f)(1)(iv)’’ in their place. State under a mutual understanding and
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![Federal Register / Vol. 81, No. 57 / Thursday, March 24, 2016 / Proposed Rules 15659
agreement, in writing, between the two upland game bird and commercial approved through the following
Official State Agencies regarding waterfowl producing eggs for human procedure:
conditions of participation and consumption premises that raise fewer (1) The sensitivity of the kit will be
supervision. than 25,000 birds annually are exempt evaluated in at least three NPIP
(2) An Official State Agency may from the special provisions of this authorized laboratories by testing
accept for participation a commercial subpart E. known positive samples, as determined
table-egg layer pullet flock, commercial ■ 20. Section 146.53 is amended as by the official NPIP procedures found in
table-egg layer flock, or a commercial follows: the NPIP Program Standards or through
meat-type flock (including an affiliated ■ a. In paragraph (a) introductory text, other procedures approved by the
flock) located in a State that does not by adding the words ‘‘or, in the case of Administrator. Field samples for which
participate in the Plan under a mutual egg-producing flocks, the regular the presence or absence of the target
understanding and agreement, in surveillance of these flocks’’ after the organism or analyte has been
writing, between the owner of the flock words ‘‘participating slaughter plant’’. determined by the current NPIP test
and the Official State Agency regarding ■ b. By adding paragraphs (a)(4) and should be used, not spiked samples or
conditions of participation and (a)(5). pure cultures. Samples from a variety of
supervision. The additions read as follows: field cases representing a range of low,
* * * * * medium, and high analyte
§ 146.53 Terminology and classification; concentrations should be used. In some
slaughter plants and premises.
§ 146.3 [Amended] cases it may be necessary to utilize
■ 16. In § 146.3, paragraph (a) is * * * * * samples from experimentally infected
amended by adding the words (a) * * * animals. Spiked samples (clinical
‘‘commercial table-egg layer pullet (4) It is a commercial upland game sample matrix with a known amount of
flock,’’ before the words ‘‘table-egg bird or waterfowl flock that produces pure culture added) should only be used
producer’’. eggs for human consumption where a in the event that no other sample types
■ 17. In § 146.11, paragraph (b) is minimum of 11 birds per flock have are available. Pure cultures should
revised to read as follows: been tested negative to the H5/H7 never be used. Additionally,
subtypes of avian influenza as provided laboratories should be selected for their
§ 146.11 Inspections. in § 146.13 (b) within 30 days of experience with testing for the target
* * * * * disposal or within a 12 month period. organism or analyte with the current
(b) A flock will be considered to be (5) It is a commercial upland game NPIP approved test. If certain conditions
conforming to protocol if it meets the bird or waterfowl flock that has an on- or interfering substances are known to
requirements as described in going active and passive surveillance affect the performance of the kit,
§ 145.33(a), § 146.43(a), or § 146.53(a) of program for H5/H7 subtypes of avian appropriate samples will be included so
this chapter. influenza that is approved by the that the magnitude and significance of
* * * * * Official State Agency and the Service. the effect(s) can be evaluated.
* * * * * (2) The specificity of the kit will be
§ 146.51 [Amended] evaluated in at least three NPIP
■ 18. Section 146.51 is amended as PART 147—AUXILIARY PROVISIONS authorized laboratories by testing
follows: ON NATIONAL POULTRY known negative samples, as determined
■ a. In the definition of commercial IMPROVEMENT PLAN by tests conducted in accordance with
upland game birds by changing the the NPIP Program Standards or other
word ‘‘purpose’’ to ‘‘purposes’’ and ■ 21. The authority citation for part 147 procedures approved by the
adding the words ‘‘eggs and/or’’ before continues to read as follows: Administrator in accordance with
the word ‘‘meat’’. Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22, § 147.53(d)(1). If certain conditions or
■ b. In the definition of commercial 2.80, and 371.4. interfering substances are known to
waterfowl, by changing the word ■ 22. In § 147.52, paragraph (d) is affect the performance of the kit,
‘‘purpose’’ to ‘‘purposes’’ and adding revised to read as follows: appropriate samples will be included so
the words ‘‘eggs and/or’’ before the that the magnitude and significance of
word ‘‘meat’’. § 147.52 Authorized laboratories. the effect(s) can be evaluated.
■ 19. Section 146.52 is amended by * * * * * (3) The kit will be provided to the
revising paragraphs (a) and (c) to read as (d) State site visit. The Official State cooperating laboratories in its final form
follows: Agency will conduct a site visit and and include the instructions for use.
recordkeeping audit at least once every The cooperating laboratories must
§ 146.52 Participation. perform the assay exactly as stated in
2 years. This will include, but may not
(a) Participating commercial upland be limited to, review of technician the supplied instructions. Each
game bird slaughter plants, commercial training records, check test proficiency, laboratory must test a panel of at least
waterfowl slaughter plants, raised-for- and test results. The information from 25 known positive samples. In addition,
release upland game bird premises, the site visit and recordkeeping audit each laboratory will be asked to test at
raised-for-release waterfowl premises, will be made available to the NPIP upon least 50 known negative samples
and commercial upland game bird and request. obtained from several sources, to
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
commercial waterfowl producing eggs provide a representative sampling of the
* * * * *
for human consumption premises shall general population. The cooperating
■ 23. Section 147.54 is revised to read
comply with the applicable general laboratories must perform a current
as follows:
provisions of subpart A of this part and NPIP procedure or NPIP approved test
the special provisions of this subpart E. § 147.54 Approval of diagnostic test kits on the samples alongside the test kit for
* * * * * not licensed by the Service. comparison.
(c) Raised-for-release upland game (a) Diagnostic test kits that are not (4) Cooperating laboratories will
bird premises, raised-for-release licensed by the Service (e.g., submit to the kit manufacturer all raw
waterfowl premises, and commercial bacteriological culturing kits) may be data regarding the assay response. Each
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![15660 Federal Register / Vol. 81, No. 57 / Thursday, March 24, 2016 / Proposed Rules
sample tested will be reported as test kit to the General Conference printing in the Commission’s Public
positive or negative, and the official Committee at the next scheduled Reference Room, 100 F Street NE.,
NPIP procedure used to classify the General Conference Committee meeting. Washington, DC 20549, on official
sample must be submitted in addition to If the Technical Committee recommends business days between the hours of
the assay response value. A completed removal, the final decision to remove 10:00 a.m. and 3:00 p.m. All comments
worksheet for diagnostic test evaluation the test will be granted in accordance received will be posted without change;
is required to be submitted with the raw with the procedures described in the Commission does not edit personal
data and may be obtained by contacting §§ 147.46, 147.47, and 147.48. identifying information from
the NPIP Senior Coordinator. Raw data Done in Washington, DC, this 18th day of submissions. You should submit only
and the completed worksheet for March 2016. information that you wish to make
diagnostic test evaluation must be Kevin Shea,
publicly available.
submitted to the NPIP Senior FOR FURTHER INFORMATION CONTACT:
Administrator, Animal and Plant Health
Coordinator 4 months prior to the next Inspection Service. Richard Holley III, Assistant Director, at
scheduled General Conference (202) 551–5614, Michael Bradley,
[FR Doc. 2016–06664 Filed 3–23–16; 8:45 am]
Committee meeting, which is when Special Counsel, at (202) 551–5594, or
BILLING CODE 3410–34–P
approval will be sought. Michael Ogershok, Attorney-Advisor, at
(5) The findings of the cooperating 202–551–5541, all in the Office of
laboratories will be evaluated by the Market Supervision, Division of Trading
NPIP Technical Committee, and the SECURITIES AND EXCHANGE and Markets, Securities and Exchange
Technical Committee will make a COMMISSION Commission, 100 F Street NE.,
majority recommendation whether to Washington, DC 20549–7010.
approve the test kit to the General 17 CFR Part 241
SUPPLEMENTARY INFORMATION:
Conference Committee at the next [Release No. 34–77407; File No. S7–03–16]
scheduled General Conference I. Background
Committee meeting. If the Technical Notice of Proposed Commission A. IEX’s Form 1
Committee recommends approval, the Interpretation Regarding Automated
final approval will be granted in Quotations Under Regulation NMS On August 21, 2015, Investors’
accordance with the procedures Exchange LLC (‘‘IEX’’) submitted to the
AGENCY: Securities and Exchange Commission a Form 1 application
described in §§ 147.46, 147.47, and
Commission. seeking registration as a national
147.48.
(6) Diagnostic test kits that are not ACTION: Proposed interpretation; request securities exchange under Section 6 of
licensed by the Service (e.g., for comment. the Securities Exchange Act of 1934
bacteriological culturing kits) and that (‘‘Act’’).1 On September 9, 2015, IEX
SUMMARY: The Securities and Exchange submitted Amendment No. 1 to its Form
have been approved for use in the NPIP Commission is publishing for comment
in accordance with this section are 1 application.2 Notice of IEX’s filing of
a proposed interpretation with respect its Form 1 application, as amended, was
listed in the NPIP Program Standards.
to the definition of automated quotation published for comment in the Federal
(b) Approved tests modification and
under Rule 600(b)(3) of Regulation Register on September 22, 2015.3
removal. (1) The specific data required
for modifications of previously NMS. Recently, IEX submitted three
approved tests will be taken on a case- DATES: Comments should be received on additional amendments to its Form 1
by-case basis by the technical or before April 14, 2016. application.4 Simultaneously with the
committee. ADDRESSES: Comments may be
(2) If the Technical Committee submitted by any of the following 1 15 U.S.C. 78f.
determines that only additional field methods: 2 In Amendment No. 1, IEX submitted updated
data is needed at the time of submission portions of its Form 1 application, including
for a modification of a previously Electronic Comments revised exhibits, a revised version of the proposed
IEX Rule Book, and revised Addenda C–2, C–3, C–
approved test, allow for a conditional • Use the Commission’s Internet 4, D–1, D–2, F–1, F–2, F–3, F–4, F–5, F–6, F–7, F–
approval for 60 days for data collection comment form (http://www.sec.gov/ 8, F–9, F–10, F–11, F–12, and F–13. IEX’s Form 1
side-by-side with a current test. The rules/sro.shtml); or application, as amended, including all of the
Exhibits referenced above, is available online at
submitting party must provide complete • Send an email to rule-comments@ www.sec.gov/rules/other.shtml as well as at the
protocol and study design, including sec.gov. Please include File Number S7– Commission’s Public Reference Room.
criteria for pass/fail to the Technical 03–16 on the subject line. 3 See Securities Exchange Act Release No. 75925
Committee. The Technical Committee (September 15, 2015), 80 FR 57261. On December
Paper Comments 18, 2015, IEX consented to an extension of time to
must review the data prior to final
approval. This would only apply to the • Send paper comments in triplicate March 21, 2016 for Commission consideration of its
Form 1 application. See Letter from Sophia Lee,
specific situation where a modified test to Brent J. Fields, Secretary, Securities General Counsel, IEX, to Brent J. Fields, Secretary,
needs additional field data with poultry and Exchange Commission, 100 F Street Commission, dated December 18, 2015.
to be approved. NE., Washington, DC 20549–1090. 4 In Amendment No. 2, filed on February 29,
2016, IEX proposed changes to its Form 1
(3) Approved diagnostic tests may be All submissions should refer to File application to, among other things, redesign its
removed from the Plan by submission of Number S7–03–16. This file number
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
outbound routing functionality to direct routable
a proposed change from a participant, should be included on the subject line orders first to the IEX router instead of directly to
Official State Agency, the Department, if email is used. To help the the IEX matching engine. See Letter from Sophia
Lee, General Counsel, IEX, to Brent J. Fields,
or other interested person or industry Commission process and review your Secretary, Commission, dated February 29, 2016, at
organization. The data in support of comments more efficiently, please use 1. In this manner, the IEX router would ‘‘interact
removing an approved test will be only one method. The Commission will with the IEX matching system over a 350
compiled and evaluated by the NPIP post all comments on the Commission’s microsecond speed-bump in the same way an
independent third party broker would be subject to
Technical Committee, and the Technical Internet Web site (http://www.sec.gov/ a speed bump.’’ See id. In Amendment No. 3, filed
Committee will make a majority rules/other.shtml). Comments are also on March 4, 2016, IEX proposed changes to its Form
recommendation whether to remove the available for Web site viewing and 1 application to clarify and correct revisions to its
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Document Created: 2016-03-24 00:57:08
Document Modified: 2016-03-24 00:57:08
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Proposed rule. | |
| Dates | We will consider all comments that we receive on or before May 23, 2016. | |
| Contact | Dr. Denise Brinson, DVM, Director, National Poultry Improvement Plan, VS, APHIS, USDA, 1506 Klondike Road, Suite 101, Conyers, GA 30094-5104; (770) 922-3496. | |
| FR Citation | 81 FR 15652 | |
| RIN Number | 0579-AE16 | |
| CFR Citation | 9
CFR
145 9 CFR 146 9 CFR 147 9 CFR 56 | |
| CFR Associated | Poultry and Poultry Products; Reporting and Recordkeeping Requirements; Animal Diseases; Indemnity Payments; Low Pathogenic Avian Influenza and Poultry |
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