Source: https://www.federalregister.gov/documents/2003/05/23/03-12995/national-poultry-improvement-plan-and-auxiliary-provisions
Timestamp: 2018-04-20 03:44:39
Document Index: 114265984

Matched Legal Cases: ['arts 145', 'art 82', 'art 82', 'arts 145', '§\u2009145', '§\u200982', '§\u200982', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009147', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009147', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009147', '§\u2009147', '§\u2009147', 'arts 82', 'art 145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009145', '§\u2009147', '§\u2009145', 'art 147']

28169-28175 (7 pages)
Docket No. 03-017-1
Update of S. enteritidis Regulations
Blood Testing for Pullorum-Typhoid
Minimum Weight of Hatching Eggs
Flock Sampling Levels for M. Gallisepticum and M. Synoviae Programs
Restrictions on Animal Protein in Mash and Pellet Feed
Reinstatement Procedure for U.S. S. Enteriditis Clean Program
New U.S. Avian Influenza Clean Programs
9 CFR Parts 145 and 147
https://www.federalregister.gov/d/03-12995 https://www.federalregister.gov/d/03-12995
We are proposing to amend the National Poultry Improvement Plan (the Plan) and its auxiliary provisions by providing new or modified sampling and testing procedures for Plan participants and participating flocks. The proposed changes were voted on and approved by the voting delegates at the Plan's 2002 National Plan Conference. These changes would keep the provisions of the Plan current with changes in the poultry industry and provide for the use of new sampling and testing procedures.
You may submit comments by postal mail/commercial delivery or by e-mail. If you use postal mail/commercial delivery, please send four copies of your comment (an original and three copies) to: Docket No. 03-017-1, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 03-017-1. If you use e-mail, address your comment to regulations@aphis.usda.gov. Your comment must be contained in the body of your message; do not send attached files. Please include your name and address in your message and “Docket No. 03-017-1” on the subject line.
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 egg-transmitted, hatchery-disseminated poultry diseases. Participation in all Plan programs is voluntary, but flocks, hatcheries, and dealers must first qualify as “U.S. Pullorum-Typhoid Clean” as a condition for participating in the other Plan programs. Also, the regulations in 9 CFR part 82, subpart C, which provide for certain testing, restrictions on movement, and other restrictions on certain chickens, eggs, and other articles due to the presence of Salmonella enteritidis, prohibit hatching eggs or newly hatched chicks from egg-type chicken breeding flocks from being moved interstate unless they are classified “U.S. S. Enteritidis Monitored” under the Plan or have met equivalent requirements for S. enteritidis control, in accordance with 9 CFR 145.23(d), under official Federal or State supervision. (The name of the “U.S. S. Enteritidis Monitored” classification has changed; as discussed below, we are proposing to amend part 82, subpart C, to reflect this change.)
The regulations in 9 CFR parts 145 and 147 (referred to below as the regulations) contain the provisions of the Plan. The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA or the Department) amends these provisions from time to time to incorporate new scientific information and technologies within the Plan.
The proposed amendments discussed in this document are consistent with the recommendations approved by the voting delegates to the National Plan Conference that was held from May 30 to June 1, 2002. Participants in the 2002 National Plan Conference represented flockowners, breeders, hatcherymen, and Official State Agencies from all cooperating States. The proposed amendments are discussed in greater detail below.
On February 25, 2002, we published in the Federal Register (67 FR 8466-8475, Docket No. 00-075-2) a final rule that, among other things, amended § 145.23(d) by changing the name of the “U.S. S. Enteritidis Monitored” classification to “U.S. S. Enteritidis Clean.” We made this change because the monitoring and prevention elements of this program had been effective enough that the focus of the program had shifted towards maintaining the freedom of flocks from Salmonella enteritidis. At the time we made this change, we should have updated § 82.34 to reflect the classification's new name, but we failed to do so. Therefore, we are proposing to change the reference to “U.S. S. Enteritidis Monitored” in § 82.34 to read “U.S. S. Enteritidis Clean” to make the regulations consistent.
We propose to reorganize § 145.14(a), which specifies the procedures for testing flocks for pullorum-typhoid, to improve that paragraph's clarity. The current paragraph does not clearly state the order in which the various tests for pullorum-typhoid should be administered. To save money and time, testing should begin with the rapid serum test, the enzyme-labeled immunosorbent assay, or the rapid whole blood plate test. These tests are considered screening tests and are highly sensitive, which may lead to false positives. To confirm positive results from these tests, the standard tube agglutination test or the microagglutination test must be used. If the standard tube agglutination test or microagglutination test confirms the earlier positive result, flock owners must submit all the reactors to an authorized laboratory for bacteriological examination. If there are four or more reactors in the flock, at least four reactors must be submitted.
Some owners of small flocks who suspect that the standard tube agglutination or microagglutination tests have produced false-positive results may be reluctant to submit reactors for bacteriological examination, because this process requires that the reactors be destroyed. In such a situation, the regulations provide that rather than immediately submitting reactors for bacteriological examination, the owner may isolate the reactors for 30 days, after which they must be retested. If the Start Printed Page 28170reactors continue to test positive, it is mandatory that the reactors be submitted for bacteriological examination.
While these procedures are enumerated in the current regulations, their presentation is somewhat unclear, with the result that tests may be administered in improper order and reactors may be destroyed unnecessarily for the purposes of bacteriological examination. The proposed reorganization of § 145.14(a) is intended to eliminate that possibility by making the regulations easier to understand.
Additionally, in the current regulations, the procedures for testing for pullorum-typhoid (§ 145.14(a)(9)) are presented after the procedures in § 145.14(a)(7) by which a flock may be determined to be free of pullorum-typhoid once a flock has tested positive for this disease. We propose to reorder these paragraphs to reflect the order in which these procedures would be undertaken by flockowners.
At one time, the Plan served as a certification program for breeders, determining the required characteristics for saleable hatching eggs of various types. Over the years, the Plan's focus shifted towards preventing the establishment and spread of poultry diseases. The poultry industry has developed its own standards for hatching eggs, and these standards are widely accepted among producers. Therefore, we believe that the NPIP requirements for the minimum weights of hatching eggs that are part of the participation criteria for certain Plan programs are no longer applicable or necessary and should be removed from the regulations.
In § 145.22, we propose to remove paragraphs (a) and (b), which require, respectively, that the minimum weight of hatching eggs sold from egg type chicken breeding flocks shall be 11/22 ounces, unless otherwise specified by the purchaser of the eggs, and that Mediterranean breed eggs shall be reasonably free from tints. In § 145.32, we propose to remove paragraph (a), which requires that the minimum weight of hatching eggs sold from meat type chicken breeding flocks shall be 110/12 ounces, except as otherwise specified by the purchaser of the eggs. In § 145.42, we propose to remove paragraph (b), which requires that the minimum weight of hatching eggs from turkey breeding flocks that are shipped interstate shall be 2 ounces for small varieties and 21/2 ounces for large varieties, unless otherwise specified by the purchaser of the eggs.
For both the U.S. M. Gallisepticum Clean and U.S. M. Synoviae Clean programs, as provided in § 145.33(c) and (e), respectively, we propose to modify the current requirements for testing male breeding birds for the diseases before adding these birds to a participating multiplier breeding flock. Instead of requiring that 3 percent of the male breeding birds be tested, we would require that 30 of these birds be tested, or, if fewer than 30 birds are being introduced, that all of these birds be tested. We believe that the 3 percent standard, if used when fewer than 1,000 male breeding birds are being added to a participating flock, can result in sample sizes that are not large enough for the test results to be statistically significant. Requiring that 30 male breeding birds be tested (or that all of the male breeding birds be tested if fewer than 30 are being introduced) would provide greater assurance that the male breeding birds being introduced are free of these diseases.
We also propose to amend § 145.33(c) and (e) by inserting a reference to the diagnostic procedure in § 145.14(b) for M. gallisepticum and M. synoviae to clarify that if the male breeding birds are tested serologically, the test must be carried out as prescribed in § 145.14(b).
For both the U.S. M. Gallisepticum Monitored and U.S. M. Synoviae Monitored programs, as provided in § 145.33(j) and (k), respectively, we propose to increase the sampling level required to retain this classification from 20 birds, 10 from the front half of the house and 10 from the back half of the house, to 30 birds, 15 from the front of the house and 15 from the back of the house. We believe that 20 birds is an insufficient sample size for testing for these diseases, and that the proposed requirement that 30 birds be tested would provide more useful results.
We propose to eliminate the restrictions on the use of animal protein in mash and pelletized feed that are currently found in the regulations governing the U.S. S. Enteriditis Clean program, in paragraphs § 145.33(h)(1)(ii)(A) and (h)(1)(ii)(B); the U.S. Salmonella Monitored program, in paragraph § 145.33(i)(1)(iii); and the U.S. Sanitation Monitored program for turkeys, in § 145.43(f)(3). Currently, animal protein used in either pelletized or mash feed under these programs must be produced under the Salmonella Education/Reduction program of the Animal Protein Products Industry (APPI) or, for the U.S. S. Enteriditis Clean and U.S. Sanitation Monitored programs, the Fishmeal Inspection Program of the National Marine Fisheries Service (NMFS). We are proposing to remove these restrictions and allow the use of any animal protein for feed under these programs.
We originally required animal protein used in pelletized or mash feed for poultry to be produced under the APPI or NMFS programs because we believed that such a requirement was an effective way to lower the risk that animal protein used in feed was contaminated with Salmonella. However, since that requirement was instituted, technological methods, such as thermal lethality treatments, and chemical products have been introduced to control the incidence of Salmonella in protein feed. These technological and chemical methods are generally more effective than the program controls in ensuring that Salmonella is not present in protein used in feed.
In fact, the control programs have often proven ineffective. For example, in 2000, Salmonella Education/Reduction Program test results showed that 20 percent of tested protein samples were positive for Salmonella. This level of positive results is not significantly different from the level of Salmonella positive results found among renderers and processors that did not operate under the APPI program. Removing the requirement that protein used in feed be produced under the APPI or NMFS programs, therefore, is not likely to reduce the quality of protein used in feed, and to the extent that it encourages the use of the more effective technological and chemical Salmonella control methods, is likely to increase that quality.
In addition, we propose to replace the current thermal lethality treatment for pelletized feed specified in the U.S. Sanitation Monitored program for turkeys by providing for the use of any of three specified thermal lethality treatments or any other equivalent thermal lethality treatment. Alternatively, we would require that a Food and Drug Administration-approved Salmonella control product be added to all finished pellets or conditioned mash feed. Turkey flocks are more likely than other poultry flocks to be fed animal protein; we have therefore determined that our regulations for treating animal protein feed for turkeys should be as specific as possible to ensure that the animal protein feed prepared for turkey flocks carries the lowest possible risk of Start Printed Page 28171infecting turkeys with Salmonella. The proposed additional requirements would further reduce the chance that turkey feed is infected with Salmonella under this program.
We propose to add a provision for reinstatement to the U.S. S. Enteriditis Clean program for meat type chicken breeding flocks and products in a new paragraph § 145.33(h)(6). This reinstatement provision would require breeders of meat type flocks to undertake corrective measures to ensure that a flock that has been removed from the U.S. S. Enteriditis Clean program due to infection is no longer affected by that bacterium, in addition to any other measures that may be specified by the Official State Agency. These measures would include testing and slaughtering infected birds based on the testing of every bird in the flock, vaccination, medication, cleaning and disinfection of houses, rodent control, and movement to premises that have been determined to be environmentally negative for S. Enteriditis as described in § 147.12(a). Once these measures have been performed, the flock would be tested and environmental drag swabs would be taken. If both tests do not indicate the presence of S. Enteriditis, the flock would be reinstated into the program.
Currently, there is no reinstatement provision for the U.S. S. Enteriditis Clean program, and as a result primary breeders who wish to participate in the program must destroy foundation level primary breeding birds if those birds are part of a flock affected with S. enteritidis. Such birds often have valuable, specific traits that cannot be duplicated, and their destruction can result in considerable losses to the primary breeder. Allowing for reinstatement of flocks into the U.S. S. Enteriditis Clean program under the proposed conditions would enable primary breeders to retain their foundation level primary breeding birds if they are not infected with S. Enteriditis while continuing to ensure that the flocks that participate in the U.S. S. Enteritidis Clean program are kept free of this disease.
We propose to add new U.S. Avian Influenza Clean programs to the regulations governing turkey breeding flocks and products in § 145.43(g) and to the regulations governing waterfowl, exhibition poultry, and game breeding flocks and products in § 145.53(e). Both of these programs are modeled on the existing U.S. Avian Influenza Clean program for meat type chicken breeding flocks and products, set out at § 145.33(l). Like the U.S. Avian Influenza Clean program for meat type chicken breeding flocks and products, the programs for turkey breeding flocks and products and waterfowl, exhibition poultry, and game breeding flocks and products would require that a sample of at least 30 birds must test negative for antibodies to avian influenza, as indicated by the agar gel immunodiffusion test specified in § 147.9. For primary breeding flocks, the maximum interval between tests would be 90 days; for multiplier breeding flocks, the maximum interval between tests would be 180 days. The program for turkeys would additionally require that if a killed influenza vaccine from a subtype other than the H5 or H7 subtypes is used for turkeys, the hemagglutinin and the neruaminidase subtypes of the vaccine must be reported to the Official State Agency for laboratory and reporting purposes.
Both of these U.S. Avian Influenza Clean programs are intended to provide flockowners with an optional way to improve their flocks' marketability in foreign countries. A program requiring regular testing of turkeys for avian influenza with the agar gel immunodiffusion test would provide a useful certification to turkey flockowners seeking to expand their exports to countries that required such testing.
Since most countries require that waterfowl, exhibition poultry, and game breeding birds be tested for avian influenza before they can be imported, the avian influenza testing program for those birds would not only provide exporters with an additional useful certification but could also save time and expense at export.
Section 145.10 contains illustrative designs or emblems that correspond to the Plan's various classifications. The design for the U.S. Avian Influenza Clean program is found in § 145.10(r), which currently reads “U.S. Avian Influenza Clean. (See §§ 145.23(h) and 145.33(l).)” Because we are proposing to establish a U.S. Avian Influenza Clean program for waterfowl, exhibition poultry, and game breeding birds, we would amend § 145.10(r) so that it also refers to § 145.53(e), which is the section that would contain the requirements of the U.S. Avian Influenza Clean program for waterfowl, exhibition poultry, and game breeding birds.
We are proposing to refer to the similar program for turkeys as the U.S. H5/H7 Avian Influenza Clean program, because its intent is to determine the presence of the H5 and H7 subtypes of avian influenza in participating flocks. However, § 145.10 does not currently contain an illustrative design that bears this title. Therefore, we are proposing to add a new paragraph (t) to § 145.10 which would read “U.S. H5/H7 Avian Influenza Clean. (See § 145.43(g).)” This paragraph would contain an appropriate illustrative design for use with this program.
We propose to modify the regulations governing the isolation and identification of Salmonella in § 147.12(b) by adding a rapid diagnostic method involving a rapid ruthenium-labeled Salmonella sandwich immunoassay to the list of approved diagnostic methods. The steps involved in using this method would be detailed in a new paragraph § 147.12(b)(3). The two other approved methods, tetrathionate enrichment with delayed secondary enrichment and pre-enrichment followed by selective enrichment (listed in paragraphs (b)(1) and (b)(2) of § 147.12, respectively), both require more time and resources to accomplish than the rapid ruthenium-labeled Salmonella sandwich immunoassay, while the latter method provides equally accurate results. Adding this method to the list of approved methods would provide greater flexibility to diagnostic laboratories while continuing to ensure accurate results in testing.
The objective of the NPIP is to provide a cooperative Industry-State-Federal program through which new technology can be effectively applied to the improvement of poultry and poultry products throughout the country. The provisions of the Plan, developed jointly by industry members and State and Federal officials, establish standards for the evaluation of poultry breeding stock and hatchery products with respect to freedom from hatchery-disseminated diseases. Participation in the program is voluntary. Currently, the NPIP has active control programs for pullorum, fowl typhoid, avian mycoplasmas, Salmonella enteritidis, and avian influenza. Start Printed Page 28172
Periodically, provisions of the Plan are amended to keep current with the development of the poultry industry and the utilization of new information as it becomes available, based on the recommendations of representatives of member States, hatcheries, dealers, flockowners, and breeders who take part in the Plan's National Plan Conference meetings. Accordingly, this proposed rule would change some of the Plan's provisions to keep the provisions of the Plan current with changes in the poultry industry, establish new certification programs, modify current disease control practices, and provide for the use of new sampling and testing procedures. The proposed changes were voted on and approved by the voting delegates at the Plan's 2002 National Plan Conference. The proposed changes have been generated by industry representatives, Official State Agencies, or Federal representatives with the goal of reducing disease risk and increasing product marketability.
The United States is the world's largest producer and exporter of poultry meat and the second-largest egg producer. In 2001, U.S. producers held a total of 441.1 million chickens, excluding commercial broilers, whose estimated value was $1.068 billion. Broiler production, which primarily comes from chickens raised under contract with a broiler processor, totaled 8.262 billion broilers with a combined live weight of 41.5 billion pounds. The value of broiler production for that year was $13.9 billion. The United States is also the world's largest turkey producer. In 2001, turkey production totaled 269 million birds with a combined live weight of 6.98 billion pounds and value of $2.8 billion. Finally, in 2000, the United States produced approximately 84.4 million eggs worth an estimated $4.3 billion.[1]
The Regulatory Flexibility Act requires that agencies consider the economic impact of their regulations on small entities. Under the North American Industry Classification System (NAICS) used by the Small Business Administration, chicken egg operations are considered small entities if they have $10.5 million or less in annual receipts (NAICS code 112310). All other poultry products and meat operations are considered small entities if they have $750,000 or less in annual receipts (NAICS code 112320).[4] As this regulation only seeks to make minor changes in a continuing program in an effort to better safeguard poultry health, the economic effects on poultry producers are not expected to be significant.
However, only those producers that voluntarily participate in the Plan will be affected. As is the case in the majority of voluntary control programs, individuals are likely to remain in the program as long as the costs of implementing the program are lower than the added benefits they receive from the program. In any event, the proposed changes would not have a significant economic effect on Plan participants.
Accordingly, we propose to amend 9 CFR parts 82, 145, and 147 as follows:
2. Section 82.34 would be amended by removing the word “Monitored” and adding the word “Clean” in its place.
3. The authority citation for part 145 would continue to read as follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4. 4. Section 145.10 would be amended as follows: a. In paragraph (r), by removing the word “and” and adding a comma in its Start Printed Page 28173place and by adding the words “, and 145.53(e)” after the citation “145.33(l)”. b. By adding a new paragraph (t) to read as set forth below.
5. Section 145.14 would be amended as follows:
6. In § 145.22, paragraphs (a) and (b) would be removed and paragraphs (c) through (e) would be redesignated as paragraphs (a) through (c), respectively.
7. In § 145.32, paragraph (a) would be removed and paragraphs (b) through (d) would be redesignated as paragraphs (a) through (c), respectively.
8. Section 145.33 would be amended as follows:
§ 145.33.
(e) * * * Start Printed Page 28174
(4) Before male breeding birds may be added to a participating multiplier breeding flock, a sample of at least 30 birds to be added, with a minimum of 10 birds per pen, shall be tested for M. synoviae as provided in § 145.14(b) or by a polymerase chain reaction (PCR)-based procedure approved by the Department. If fewer than 30 male breeding birds are being added, all the birds shall be tested as described above. The male birds shall be tested no more than 14 days prior to their intended introduction into the flock. If the serologic testing of the birds yields hemagglutination inhibition titers of 1:40 or higher as provided in § 145.14(b), or if the PCR testing is positive for M. synoviae, the male birds may not be added to the flock and must be either retested or destroyed.
(6) A pedigree, experimental, or great-grand parent flock that is removed from the U.S. S. Enteritidis Clean program may be reinstated whenever the following conditions are met:
9. In § 145.42, paragraph (b) would be removed and paragraphs (c) and (d) would be redesignated as paragraphs (b) and (c), respectively.
10. Section 145.43 would be amended as follows:
(iii) All feed is to be stored and transported in such a manner as to prevent possible contamination with pathogenic bacteria. Start Printed Page 28175
(g) U.S. H5/H7 Avian Influenza Clean. This program is intended to be the basis from which the turkey breeding industry may conduct a program for the prevention and control of the H5 and H7 subtypes of avian influenza. It is intended to determine the presence of the H5 and H7 subtypes of avian influenza in breeding turkeys through routine serological surveillance of each participating breeding flock. A flock, and the hatching eggs and poults produced from it, will qualify for this classification when the Official State Agency determines that it has met one of the following requirements:
(2) It is a multiplier breeding flock in which a minimum of 30 birds has been tested negative for antibodies to the H5 and H7 subtypes of avian influenza by the agar gel immunodiffusion test specified in § 147.9 when more than 4 months of age. To retain this classification:
11. In § 145.53, a new paragraph (e) would be added to read as follows:
(e) U.S. Avian Influenza Clean. This program is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of avian influenza. It is intended to determine the presence of avian influenza in waterfowl, exhibition poultry and game bird breeding flocks through routine serological surveillance of each participating breeding flock. A flock, and the hatching eggs and chicks produced from it, will qualify for this classification when the Official State Agency determines that it has met one of the following requirements:
12. The authority citation for part 147 would continue to read as follows:
13. Section 147.12 would be amended as follows:
a. In paragraph (b), introductory text, the words “or the rapid detection method” would be added after the word “procedures.”
b. A new paragraph (b)(3) would be added to read as set forth below.
[FR Doc. 03-12995 Filed 5-22-03; 8:45 am]