[Federal Register Volume 64, Number 153 (Tuesday, August 10, 1999)]
[Proposed Rules]
[Pages 43301-43314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20540]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 145 and 147
[Docket No. 98-096-1]
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 (the Plan) and its auxiliary provisions by establishing new
program classifications and 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 1998 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.
DATES: We invite you to comment on this docket. We will consider all
comments that we receive by October 12, 1999.
ADDRESSES: Please send your comment and three copies to: Docket No. 98-
096-1, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03 4700
River Road, Unit 118, Riverdale, MD 20737-1238. Please state that your
comment refers to Docket No. 98-096-1.
You may read any comments that we receive on this docket in our
reading room. The reading room 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) 690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS rules, are available on the Internet at http://
www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Mr. Andrew R. Rhorer, Senior
Coordinator, Poultry Improvement Staff, National Poultry Improvement
Plan, Veterinary Services, APHIS, USDA, 1498 Klondike Road, Suite 200,
Conyers, GA 30094-5104; (770) 922-3496.
[[Page 43302]]
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 egg-transmitted, hatchery-
disseminated poultry diseases. Participation in all Plan programs is
voluntary, but flocks, hatcheries, and dealers must qualify as ``U.S.
Pullorum-Typhoid Clean'' before participating in any other Plan
program. 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, require that no hatching eggs or
newly hatched chicks from egg-type chicken breeding flocks may be 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
supervision.
The Plan identifies States, flocks, hatcheries, and dealers 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 and 147 (referred to below as
the regulations) contain the provisions of the Plan. The Animal and
Plant Health Inspection Service (APHIS) amends these provisions from
time to time to incorporate new scientific information and technologies
within the Plan. In this document, we are proposing to amend the
regulations to:
1. Establish two new classifications: ``U.S. Avian Influenza
Clean'' for primary and multiplier egg- and meat-type breeding chicken
flocks and ``U.S. Mycoplasma Meleagridis Clean State, Turkeys.''
2. Identify the agar gel immunodiffusion (AGID) test and the
enzyme-linked immunosorbent assay (ELISA) as official tests for avian
influenza in the Plan.
3. Allow the use of Food and Drug Administration (FDA) approved
feed sanitizing agents or salmonella control products in certain
chicken and turkey breeding flocks.
4. Eliminate references to Salmonella typhimurium throughout the
regulations.
5. Add the colony lift assay for group D salmonella and eliminate
the referral of all group D salmonella to APHIS' National Veterinary
Services Laboratories (NVSL) in the laboratory protocol for isolation
and identification of salmonella in breeding turkeys.
6. Make several changes to the duties of the General Conference
Committee of the NPIP.
7. Establish technical protocol for culturing chick meconium.
8. Provide for the use of either chick papers or meconium as
testing samples in the ``U.S. Salmonella Monitored'' program of meat-
type breeding chickens.
9. Amend the procedure for determining the status of a flock
reacting to tests for Mycoplasma gallisepticum, M. synoviae, and M.
meleagridis.
10. Provide for the participation of emu, rhea, and cassowary
breeding flocks in the provisions of the Plan.
11. Remove exceptions to the requirements for pullorum typhoid
clean States that pertain to turkey hatcheries or supply flocks.
12. Add or amend several definitions.
These proposed amendments are consistent with the recommendations
approved by the voting delegates to the National Plan Conference that
was held from July 15 to 17, 1998.
Participants in the 1998 National Plan Conferences represented
flockowners, breeders, hatcherymen, and Official State Agencies from
all cooperating States. The proposed amendments are discussed in
greater detail below.
U.S. Avian Influenza Clean
We are proposing to add a new Sec. 145.23(h) to establish a new
``U.S. Avian Influenza Clean'' classification for egg-type chickens and
meat-type chickens. This proposed program is intended to be the basis
from which the breeding-hatchery industry could conduct a program for
the prevention and control of avian influenza. The program would enable
flockowners to determine the presence of avian influenza in breeding
chickens through routine serological surveillance of each participating
breeding flock. A flock and the hatching eggs and chicks produced from
it would qualify for this proposed classification when the Official
State Agency determined that they have met the qualifying requirements.
For primary breeding flocks, a minimum of 30 birds would have to
have been tested negative for antibodies to avian influenza when the
flock is more than 4 months of age to qualify for the classification.
After qualifying, a sample of at least 30 birds from the flock would
have to be tested negative at intervals of 90 days to retain the
classification. As noted above, this routine serological surveillance
would allow flockowners to monitor their flocks for the presence of
avian influenza. Under the proposed classification criteria,
flockowners could test samples of fewer than 30 birds at any one time
if all pens were equally represented and a total of 30 birds was tested
within each 90-day period. This would provide an alternative for
flockowners who may find it easier to spread the necessary testing out
over a period of time rather than testing all the birds at the same
time.
The qualifying requirements for multiplier breeding flocks would be
the same as for primary breeding flocks with one exception: Instead of
having to test a sample of 30 birds every 90 days to retain the
classification, the testing interval for multiplier breeding flocks
would be 30 birds every 180 days. This longer testing interval for
multiplier breeding flocks is used throughout the Plan in other disease
classifications and is appropriate because there are many more
multiplier breeding flocks than primary breeding flocks--the ratio is
roughly 5\1/2\ to 1. With the much larger number of multiplier breeding
flocks, it works out that multiplier breeding flocks would actually be
tested nearly three times more often during the course of a year than
the primary breeding flocks in a given State. Given that the multiplier
breeding flocks are held in comparatively closer proximity and looser
biosecurity conditions, relative to the primary breeding flocks, the
health status of one multiplier flock is considered a reliable
indicator of the health status of the surrounding multiplier flocks.
This is especially true with regard to avian influenza, given the fact
that the level of avian influenza infection in the flocks in an area
where the disease is present would be very high, if not 100 percent.
Given these considerations, we believe that this longer interval for
testing multiplier breeding flocks would provide an appropriate level
of surveillance for avian influeza.
U.S. M. Meleagridis Clean State, Turkeys
We are proposing to add a new Sec. 145.44(e) to establish a new
``U.S. M. Meleagridis Clean State'' classification for turkeys. This
proposed new classification would be given to qualifying States in
which all turkey flocks have been shown to be free of Mycoplasma
meleagridis and in which no M. meleagridis has been detected in
[[Page 43303]]
turkey flocks for at least the previous 12 months.
For a State to qualify for this proposed new classification, all
turkey breeding flocks in production in the State would have to qualify
as ``U.S. M. Meleagridis Clean'' or its equivalent, and all turkey
hatcheries within the State would have to handle only products that are
classified as ``U.S. M. Meleagridis Clean'' or its equivalent.
Additionally, all shipments of products from turkey breeding flocks
other than those classified as ``U.S. M. Meleagridis Clean'' or its
equivalent into the State would be prohibited.
All persons performing poultry disease diagnostic services within
the State would be required to report to the Official State Agency
within 48 hours the source of all turkey specimens that are identified
as being infected with M. meleagridis; such reports would have to be
followed by an investigation by the Official State Agency to determine
the origin of the infection. Any turkey breeding flock found to be
infected with M. meleagridis would have to be quarantined until
marketed under supervision of the Official State Agency.
If a State no longer met any of the above conditions, or if
repeated outbreaks of M. meleagridis occurred in turkey breeding
flocks, or if an infection spread from the premises on which it
originated, APHIS would have grounds to revoke its determination that
the State was entitled to the classification. Such action would not be
taken until APHIS had conducted a thorough investigation and the
Official State Agency had been given an opportunity for a hearing in
accordance with rules of practice adopted by the Administrator.
Tests for Avian Influenza
We are proposing to amend Sec. 145.14, ``Blood testing,'' to
designate the agar gel immunodiffusion (AGID) test and the enzyme-
linked immunosorbent assay (ELISA) as the official Plan blood tests for
avian influenza. These tests would have to be conducted using antigens
or test kits approved by the Department and the Official State Agency
and would have to be performed in accordance with the recommendations
and instructions provided by the test's producer or manufacturer. These
proposed requirements would ensure that the tests are routinely
conducted in a consistent and accurate manner. We would allow the use
of either test because some laboratories find the ELISA a less labor-
intensive test to perform, but the AGID is recognized by the Office of
International Epizootics as the international standard test for avian
influenza. We would require, however, that any ELISA positive tests
would have to be check tested using the AGID, since the AGID test is
specifically required by many of the countries to which the United
States poultry industry exports its products.
The instructions for conducting the AGID and ELISA tests would be
set out in a new Sec. 147.9. Paragraph (a) of the proposed new section
would provide detailed instructions regarding the use of AGID test as a
screening test for avian influenza, including lists of the materials
and reagents needed for the test and directions for preparing the avian
influenza AGID agar, performing the AGID test, and interpreting test
results. Paragraph (b) of the proposed new section would explain that
the ELISA may also be used as a screening test for avian influenza and
would require the use of federally licensed ELISA kits in accordance
with the manufacturer's instructions. The AGID testing protocols, which
are set out in Sec. 147.9 in the rule portion of this document, were
developed by NVSL and have been reviewed by avian influenza technical
experts. Because proposed Sec. 147.9 contains a footnote, we would also
renumber the remaining footnotes in part 147 to accommodate its
inclusion.
Feed and Salmonella Control Products
The definitions of baby poultry in Sec. 145.1, chicks in
Secs. 145.21 and 145.31, and poults in Sec. 145.41 all refer to newly
hatched birds that have not been fed or watered. The limitation on
feeding and watering can be traced back to the standard practices for
shipping mail order chicks and poults that were developed when it was
impractical to include food or water in the chick or poult boxes. Now,
however, gels are available that can easily be placed in chick and
poult boxes. The use of these gels has become widespread in the
industry and has virtually eliminated primary mortality in baby poultry
due to dehydration. Therefore, we are proposing to amend the
definitions of baby poultry, chicks, and poults to remove the words
``that have not been fed or watered'' in order for the regulations in
part 145 to reflect actual poultry industry practice.
We do believe, however, that it is important to ensure that the
gels or other nutrients provided to the baby poultry in participating
flocks and hatcheries do not expose the chicks or poults to any of the
diseases addressed by Plan programs. Accordingly, we are proposing to
add a paragraph to each of the subparts in part 145 to inform Plan
participants that any nutritive material provided to baby poultry must
be free of the avian pathogens that are officially represented in Plan
disease classifications, which are listed in Sec. 145.10. This
paragraph would be added to Sec. 145.6, ``Specific provisions for
participating hatcheries,'' in subpart A and to the ``Participation''
sections (i.e., Secs. 145.21, 145.31, 145.41, 145.51, and 145.61) of
the other five subparts.
We are also proposing to amend Secs. 145.23(d), 145.33(h), and
145.43(f) to provide for the use of FDA-approved salmonella control
products on finished feed as an additional measure for reducing
salmonella in breeding flocks. The Plan's provisions currently provide
for the use of feed with no animal protein or require feed containing
animal protein to meet specified requirements. Allowing salmonella
control products that have been approved by the FDA to be used in
poultry feed would provide flockowners with an alternative means of
reducing the likelihood of salmonella being introduced into their
breeding flocks through feed.
Addition of Emus, Rheas, and Cassowaries
We are proposing to amend parts 145 and 147 to provide for the
participation of emu, rhea, and cassowary breeding flocks in the
provisions of the Plan. The proposed addition to the Plan of provisions
for emu, rhea, and cassowary breeding flocks was voted on and approved
by the voting delegates at the Plan's 1998 National Plan Conference and
follows the addition in 1998 of provisions for the participation of
ostrich breeding flocks. Adding provisions to the Plan for emu, rhea,
and cassowary breeding flocks would make it possible for the owners of
those flocks to voluntarily participate in the Plan's programs for the
prevention and control of egg-transmitted, hatchery-disseminated
poultry diseases. To integrate emus, rheas, and cassowaries into the
provisions of the Plan, we are proposing to amend several sections of
the regulations.
First, we would add emus, rheas, and cassowaries to the definition
of poultry in Sec. 145.1 to ensure that the general provisions of the
regulations would apply, where applicable, to emus, rheas, and
cassowaries as well as to the types of poultry already covered by the
Plan. With the proposed addition of emus, rheas, and cassowaries, the
definition of poultry would read: ``Domesticated fowl, including
chickens, turkeys, ostriches, emus, rheas, and cassowaries, waterfowl,
and game birds, except doves and pigeons, which are bred for the
[[Page 43304]]
primary purpose of producing eggs or meat.''
Under Sec. 145.3(c), ``Participation,'' a Plan participant in any
State must participate with all of his poultry hatching egg supply
flocks and hatchery operations in that State. To demonstrate compliance
with that requirement, the Plan participant must submit a report of
each of his breeding flocks within the State to the Official State
Agency before the birds in a breeding flock reach 24 weeks of age or,
in the case of ostriches, before the birds reach 20 months of age.
Under the provisions of this proposed rule, those participation
requirements would also apply to emu, rhea, and cassowary hatching egg
supply flocks and hatchery operations. Because emus, rheas, and
cassowaries mature at a rate comparable to that of ostriches, a
participant would have to report his or her emu, rhea, or cassowary
breeding flocks to the Official State Agency before the birds in the
flock reach 20 months of age, as is the case for ostriches, rather than
24 weeks of age as required for other poultry.
We would amend the introductory text of Sec. 145.14 by adding a
provision regarding the blood testing of emus, rheas, and cassowaries.
That text currently states that poultry must be more than 4 months of
age when blood tested for an official classification, except for
turkeys, which may be blood tested at 12 weeks of age; game birds,
which may be blood tested when more than 4 months of age or upon
reaching sexual maturity, whichever comes first; and ostriches, which
must be more than 12 months of age.
In providing for the blood testing of emus, rheas, and cassowaries,
we are also proposing to amend the exception regarding ostriches.
Specifically, we would provide that ostrich, emu, rhea, and cassowary
candidates would be blood tested when at least 12 months of age or upon
reaching sexual maturity, depending upon the species and at the
discretion of the Official State Agency. (As noted in the previous
paragraph, ostriches currently must be ``more than 12 months of age''
when blood tested.) We would provide for blood testing to occur when
the birds are at least 12 months of age or upon reaching sexual
maturity because these four species will not reach sexual maturity at
the same age, although approximately a year after hatching is an
appropriate general time frame. The immature birds are kept in a
juvenile rearing facility for about a year after hatching, so it would
not be necessary to test them for an official classification until such
time as they were ready to be integrated into a breeding flock.
The special provisions for emu, rhea, and cassowary breeding flocks
would be added to subpart F (Secs. 145.61 through 145.63), which
currently pertains only to ostriches. To include emus, rheas, and
cassowaries in subpart F, we would add the words ``emu, rhea, and
cassowary'' after the word ``ostrich'' in the following places:
The title of the subpart. As amended, the title would read
``Special Provisions for Ostrich, Emu, Rhea, and Cassowary Breeding
Flocks.''
The introductory text of Sec. 145.62. Emus, rheas, and cassowaries
would be subject to the section's requirement that participating
flocks, and the eggs and chicks produced from them, must comply with
the applicable general provisions of subpart A and the special
provisions of subpart F.
Paragraph (a) of Sec. 145.62. Emus, rheas, and cassowaries would
lose their identity under Plan terminology--that is, they would not be
considered U.S. Pullorum-Typhoid Clean poultry--if they were not
maintained under the conditions prescribed in Sec. 145.5(a). Under
Sec. 145.5(a), poultry equipment, poultry houses, and the land in their
immediate vicinity must be kept in sanitary condition, and the
participating flock, its eggs, and all equipment used in connection
with the flock must be kept separated from nonparticipating flocks. The
sanitation and segregation described in Sec. 145.5(a) are important
factors in maintaining the health of flocks, which is why we would
require that those conditions be met in order for started poultry to
retain its identity under Plan terminology.
Paragraph (b) of Sec. 145.62. The hatching eggs produced by emu,
rhea, and cassowary primary breeding flocks would have to be fumigated
or otherwise sanitized; that paragraph also refers the reader to
Sec. 147.22, which contains procedures for the sanitation of hatching
eggs. This proposed requirement for the sanitation of hatching eggs
would serve to help prevent the transmission of egg-disseminated
diseases that could be spread by unsanitized eggs.
Paragraph (a) of Sec. 145.63. Emu, rhea, and cassowary flocks would
be subject to the same qualifying criteria for the U.S. Pullorum-
Typhoid Clean classification as are ostrich flocks. Emu, rhea, and
cassowary flocks seeking the U.S. Pullorum Typhoid Clean classification
would have to demonstrate their freedom from pullorum and typhoid to
the Official State Agency through annual blood testing or a
bacteriological monitoring program.
The regulations in Sec. 147.45 regarding official delegates to Plan
conferences refer to the programs prescribed in subparts B, C, D, and E
of part 145. Similarly, the regulations in Sec. 147.46 refer to four
committees within the Plan (egg-type chickens, meat-type chickens,
turkeys, and waterfowl, exhibition poultry, and game birds) that have
been established to consider possible changes to the Plan's provisions.
In order to fully integrate ostrich, emu, rhea, and cassowary flocks
into the Plan and provide for the full participation of their
flockowners, we are proposing to amend Sec. 147.45 so that it refers to
subpart F and Sec. 147.46 so that it refers to a committee for
ostriches, emus, rheas, and cassowaries.
Mycoplasma Status of Flocks
In Sec. 147.6, ``Procedure for determining the status of flocks
reacting to tests for Mycoplasma gallisepticum, Mycoplasma synoviae,
and Mycoplasma meleagridis,'' paragraph (a)(14) currently provides that
a flock will be considered infected with mycoplasma based on the
results of an in vivo bio-assay, polymerase chain reaction (PCR) based
procedures, or cultural examinations. That paragraph does, however,
provide that if only the bio-assay is positive, additional in vivo bio-
assays, PCR-based procedures, or cultural examinations may be conducted
by the Official State Agency before a final determination on the
flock's mycoplasma status is made. In this document, we are proposing
to amend that paragraph to provide the same opportunity for additional
testing in instances when only the results of the PCR-based procedure
are positive. This proposed change would allow Official State Agencies
to corroborate the findings of the PCR-based procedures through the use
of seroconversion or culture isolation of the mycoplasma organism.
Colony Lift Assay
We are proposing to amend Sec. 147.11(b), which contains
bacteriological examination procedures for use with turkey specimens
and environmental specimens from turkey flocks, to provide for the use
of the colony lift assay as a means for laboratories to pick group D
salmonella colonies from selective and non-selective agar culture
plates. Group D salmonella colonies are difficult to detect on agar
culture plates, so allowing the use of a group D colony lift assay
would increase the sensitivity of the culture procedure by eliminating
the randomness of selecting colonies, as the
[[Page 43305]]
randomness could lead to group D cultures being missed on the agar
plate.
We are also proposing to amend the turkey culturing provisions in
Sec. 147.11(b) to remove the requirement that all salmonella group D
cultures be referred to NVSL for serotyping. Authorized laboratories
are capable of conducting the serotyping themselves, so there is no
need for the cultures to be referred to NVSL. These proposed changes
would make the turkey culturing requirements consistent with the
corresponding requirements for egg-type and meat-type chickens.
Chick Meconium Testing Procedure
We are proposing to add a new Sec. 147.18 to provide a testing
procedure for chick meconium. This procedure, which is set out in the
rule portion of this document, would be added because the ``U.S.
Salmonella Monitored'' classification requires the testing of chick
meconium. Because the testing is required by the Plan, it is necessary
to provide an official procedure for the collection of samples and
laboratory testing. The testing protocol was developed by scientists
from the Primary Poultry Breeders Veterinarian Roundtable who have
expertise in salmonella isolation and identification.
General Conference Committee
Section 147.43 explains the membership, duties, and functions of
the Plan's General Conference Committee (GCC), which is the body that
provides advice and assistance to the Department in its administration
of the NPIP. At the 1998 National Plan Conference, the voting delegates
approved additional duties that the Plan membership wishes the GCC to
undertake. Those additional duties are:
Advise and make recommendations to the Department to the
relative importance of maintaining, at all times, adequate Department
funding for the NPIP to enable the Senior Coordinator and staff to
fully administer the provisions of the Plan.
Advise and make yearly recommendations to the Department
with respect to the NPIP budget well in advance of the start of the
budgetary process.
Serve as a direct liaison between the NPIP and the United
States Animal Health Association.
Advise and make recommendations to the Department
regarding NPIP involvement or representation at poultry industry
functions and activities as deemed necessary or advisable for the
purposes of the NPIP.
We are, therefore, proposing to amend Sec. 147.43 to reflect these
additional advisory and liaison duties.
Definitions
In Sec. 145.1, we are proposing to amend the definition of
authorized laboratory and to add a definition of independent flock. The
definition of authorized laboratory currently reads: ``A laboratory
designated by an Official State Agency, subject to review by the
Service, to perform the blood testing and bacteriological examinations
provided for in this part.'' We are proposing to add to the end of that
definition the following: ``The Service's review will include, but will
not necessarily be limited to, checking records, laboratory protocol,
check-test proficiency, periodic duplicate samples, and peer review. A
satisfactory review will result in the authorized laboratory being
recognized by the Service as a nationally approved laboratory qualified
to perform the blood testing and bacteriological examinations provided
for in this part.'' Authorized laboratories have developed into a
significant component of the Plan, and the types of tests that are
conducted by authorized laboratories on behalf of the NPIP have become
more varied in recent years as the Plan has become involved in the
certification of essentially all of the live poultry and poultry meat
products produced in the United States. The delegates at the Plan's
1998 National Plan Conference voted to add the specific review elements
described above to the definition of authorized laboratory in order to
provide for uniformity and consistency among the Plan's 125 authorized
laboratories.
There are three categories of participation in the NPIP:
Hatcheries, independent flocks, and dealers. Hatcheries and dealers are
already addressed in Sec. 145.1, but there is not currently a
definition of the term ``independent flock.'' Therefore, we are
proposing to add the following definition of independent flock to
Sec. 145.1: ``A flock that produces hatching eggs and that has no
ownership affiliation with a specific hatchery.''
We are also proposing to amend Sec. 145.61, which provides
definitions for the specific provisions of subpart F. That section does
not currently include a definition for the term ``chick,'' which is
used several times in that subpart. Therefore, we are also proposing to
amend Sec. 145.61 to add a definition of chick, which would read
``Newly hatched ostriches, emus, rheas, or cassowaries.'' Adding this
definition, which is consistent with the definition provided for the
same term in the other four subparts of part 145, would clarify what is
intended when the term ``chick'' is used in subpart F.
Miscellaneous
Prior to 1970, the provisions of the regulations that apply to
turkeys were not part of the NPIP, but were instead part of the
National Turkey Improvement Plan (NTIP). Because turkeys were not
included in the NPIP, the NPIP regulations specifically excluded turkey
hatcheries, hatchery supply flocks, and breeding flocks from the
criteria used to determine the pullorum-typhoid status of meat-type and
egg-type chicken breeding flocks and waterfowl, exhibition poultry, and
game bird breeding flocks. When the NTIP was integrated into the NPIP,
those exemptions should have been removed from the regulations but were
not, which has resulted in a discrepancy between the U.S. Pullorum-
Typhoid Clean classification criteria for turkeys and the same criteria
for chickens and waterfowl, exhibition poultry, and game birds. A
similar discrepancy exists between the U.S. Pullorum-Typhoid Clean
classification criteria for egg- and meat-type chicken supply flocks
and the requirements for waterfowl, exhibition poultry, and game bird
supply flocks. In order to eliminate those discrepancies, we are
proposing to amend Secs. 145.23, 145.33, and 145.53 to eliminate the
incorrect exemptions discussed in this paragraph.
We are also proposing to amend Sec. 145.1 to remove the definition
of S. typhimurium infection or typhimurium because the disease is not
referred to, nor is the term itself used, in part 145. Further, because
the Plan does not include any programs for the prevention or control of
Salmonella typhimurium, the instructions provided in Sec. 147.4, ``The
tube agglutination test for S. typhimurium,'' are unnecessary.
Therefore, we are proposing to remove Sec. 147.4 from the regulations.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
The rule has been determined to be not significant for the purposes of
Executive Order 12866 and, therefore, has not been reviewed by the
Office of Management and Budget.
The proposed changes contained in this document are based on the
recommendations of representatives of member States, hatcheries,
dealers, flockowners, and breeders who took part in the Plan's 1998
National Plan Conference. The proposed changes would amend the Plan and
its auxiliary
[[Page 43306]]
provisions by establishing new program classifications and 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 1998 National Plan
Conference. These changes would keep the provisions of the Plan current
with changes in the poultry industry and provide for the use of new
sampling and testing procedures.
The Plan serves as a ``seal of approval'' for egg and poultry
producers in the sense that tests and procedures recommended by the
Plan are considered optimal for the industry. In all cases, the changes
proposed in this document have been generated by the industry itself
with the goal of reducing disease risk and increasing product
marketability. Because participation in the Plan is voluntary,
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.
Assuming they wished to voluntarily remain in the program, the cost
to comply with the proposed protocols, tests, classification schemes,
etc. would be borne primarily by the approximately 12 primary breeders
in NPIP. However, the net economic effect of the proposed changes on
those breeders is expected to be positive over the long term. This is
because the breeders' compliance costs should be more than offset by
the expected benefits resulting from compliance, i.e., increased U.S.
poultry exports. U.S. exports are expected to increase because, by
serving to reduce disease risk, the proposed protocols and procedures
should make domestic poultry more marketable in foreign markets. That
the net economic effect of the proposed changes on the poultry industry
is expected to be positive is evidenced by the fact the industry
participants of NPIP themselves initiated the proposed changes.
The precise dollar amount of the costs that the breeders would
incur to comply with the proposed changes is not available. However,
those costs are not expected to be significant, especially since many
of the proposed changes are no more than technical corrections to the
provisions of the Plan or are intended to bring those provisions into
conformity with current developments in the scientific community. In
1997, the dollar value of U.S. exports of meat and edible offal of
poultry (fresh, chilled, and frozen) totaled $2.2 billion (World Trade
Atlas, September 1998 edition). Even if exports increased by only 1
percent as a result of the proposed changes, the benefit would be $22
million.
In any event, the breeder participants in NPIP always have the
option of withdrawing from the Plan, in which case they would not be
subject to the proposed changes. As indicated above, industry
participation in the NPIP is voluntary.
Economic Effects on Small Entities
The Regulatory Flexibility Act requires that agencies consider the
economic effects of its rules on small entities, i.e., small
businesses, organizations, and governmental jurisdictions. The changes
proposed in this document are not expected to have a significant
economic effect on a substantial number of small entities, if for no
other reason than few, if any, of those entities most affected by the
proposed changes--i.e., NPIP-participating breeders and producers--are
small in size. The U.S. Small Business Administration's small entity
threshold for almost all standard industrial classification categories
for poultry and egg producers is annual revenues of $0.5 million or
less. We believe that most, if not all, breeders and producers
participating in the Plan generate annual revenues in excess $0.5
million.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action would
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 7 CFR part 3015, subpart V.)
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are in conflict with this rule will
be preempted; (2) no retroactive effect will be given to this rule; and
(3) administrative proceedings will not be required before parties may
file suit in court challenging this rule.
Paperwork Reduction Act
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. 98-096-1.
Please send a copy of your comments to: (1) Docket No. 98-096-1,
Regulatory Analysis and Development, PPD, APHIS, suite 3C03, 4700 River
Road, Unit 118, Riverdale, MD 20737-1238, 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.
The NPIP is a voluntary Federal-State-industry mechanism for
controlling certain poultry diseases and for improving poultry breeding
flocks and products through disease control techniques. APHIS is
responsible for administering the Plan, the primary purpose of which is
to protect the health of the U.S. poultry population.
This proposed rule would, among other things, amend the provisions
of the Plan to provide for the participation of emu, rhea, and
cassowary breeding flocks in the Plan. This would make it possible for
the owners of these breeding flocks to voluntarily participate in the
NPIP's programs for the prevention and control of egg-transmitted,
hatchery-disseminated poultry diseases. Including emu, rhea, and
cassowary in the provisions of the Plan would enhance our ability to
protect the United States against certain poultry diseases.
Our proposed rule would also establish a new ``U.S. M. Meleagridis
Clean State'' classification for turkeys that would be awarded to
qualifying States in which all turkey flocks have been shown to be free
of this disease. Achieving this classification would enhance the value
of turkey products in national and international trade, and would
provide flock owners with added incentive to eliminate this disease
from their flocks.
Expanding the Plan to include emu, rhea, and cassowary breeding
flocks and establishing a ``U.S. M. Meleagridis Clean State''
classification for turkeys will necessitate the use of two information
collection activities that will (1) alert us to the disease status of
turkeys in any given State and (2) alert us when any given owner of
emu, rhea, or cassowary flocks opts to enroll these flocks in the Plan.
We are asking OMB to approve our use of these information collection
activities, which are a necessary element of the Plan's
[[Page 43307]]
programs to prevent the spread of contagious poultry diseases within
the United States.
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;
(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 0.2 hours per response.
Respondents: Flock owners, breeders, hatchery operators, and State
veterinary medical officers.
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: 2 hours.
Copies of this information collection can be obtained from:
Clearance Officer, OCIO, USDA, room 404-W, 14th Street and Independence
Avenue, SW., Washington, DC 20250.
List of Subjects in 9 CFR Parts 145 and 147
Animal diseases, Poultry and poultry products, Reporting and
recordkeeping requirements.
Accordingly, we are proposing to amend 9 CFR parts 145 and 147 as
follows:
PART 145--NATIONAL POULTRY IMPROVEMENT PLAN
1. The authority citation for part 145 would continue to read as
follows:
Authority: 7 U.S.C. 429; 7 CFR 2.22, 2.80, and 371.2(d).
2. Section 145.1 would be amended as follows:
a. The definition of authorized laboratory would be revised to read
as set forth below.
b. The definition of baby poultry would be revised to read as set
forth below.
c. A new definition of independent flock would be added, in
alphabetical order, to read as set forth below.
d. The definition of poultry would be amended by adding the words
``emus, rheas, cassowaries,'' immediately after the word
``ostriches,''.
e. The definition of S. typhimurium infection or typhimurium would
be removed.
Sec. 145.1 Definitions.
* * * * *
Authorized laboratory. A laboratory designated by an Official State
Agency, subject to review by the Service, to perform the blood testing
and bacteriological examinations provided for in this part. The
Service's review will include, but will not necessarily be limited to,
checking records, laboratory protocol, check-test proficiency, periodic
duplicate samples, and peer review. A satisfactory review will result
in the authorized laboratory being recognized by the Service as a
nationally approved laboratory qualified to perform the blood testing
and bacteriological examinations provided for in this part.
Baby poultry. Newly hatched poultry (chicks, poults, ducklings,
goslings, keets, etc.).
* * * * *
Independent flock. A flock that produces hatching eggs and that has
no ownership affiliation with a specific hatchery.
* * * * *
Sec. 145.3 [Amended]
3. In Sec. 145.3, the introductory text of paragraph (c) would be
amended by adding the words ``emus, rheas, cassowaries,'' immediately
after the word ``ostriches,''.
4. In Sec. 145.6, paragraph (e) would be redesignated as paragraph
(f) and a new paragraph (e) would be added to read as follows:
Sec. 145.6 Specific provisions for participating hatcheries.
* * * * *
(e) Any nutritive material provided to baby poultry must be free of
the avian pathogens that are officially represented in the Plan disease
classifications listed in Sec. 145.10.
* * * * *
5. In Sec. 145.10, new paragraphs (r) and (s) would be added to
read as follows:
Sec. 145.10 Terminology and classification; flocks, products, and
States.
* * * * *
(r) U.S. Avian Influenza Clean. (See Secs. 145.23(h) and
145.33(l).)
BILLING CODE 3410-34-U
[GRAPHIC] [TIFF OMITTED] TP10AU99.018
[[Page 43308]]
(s) U.S. M. Meleagridis Clean State, Turkeys. (See Sec. 145.44(e).)
[GRAPHIC] [TIFF OMITTED] TP10AU99.019
BILLING CODE 3410-34-C
6. Section 145.14 would be amended as follows:
a. In the introductory text at the end of the first sentence, the
words ``and ostriches blood tested under subpart F must be more than 12
months of age'' would be removed and the words ``and ostrich, emu,
rhea, and cassowary candidates must be blood tested when at least 12
months of age or upon reaching sexual maturity, depending upon the
species and at the discretion of the Official State Agency'' would be
added in their place.
b. A new paragraph (d) would be added to read as follows:
Sec. 145.14 Blood testing.
* * * * *
(d) For avian influenza. The official blood tests for avian
influenza are the agar gel immunodiffusion (AGID) test and the enzyme-
linked immunosorbent assay (ELISA).
(1) The AGID test must be conducted on all ELISA-positive samples.
Positive tests by AGID or ELISA must be further tested by Federal
Reference Laboratories. Final judgment may be based upon further
sampling or culture results.
(2) The tests must be conducted using antigens or test kits
approved by the Department or the Official State Agency and must be
performed in accordance with the recommendations of the producer or
manufacturer.
* * * * *
7. In Sec. 145.21, the definition of chicks would be revised to
read as follows:
Sec. 145.21 Definitions.
* * * * *
Chicks. Newly hatched chickens.
* * * * *
8. In Sec. 145.22, a new paragraph (e) would be added to read as
follows:
Sec. 145.22 Participation.
* * * * *
(e) Any nutritive material provided to chicks must be free of the
avian pathogens that are officially represented in the Plan disease
classifications listed in Sec. 145.10.
9. Section 145.23 would be amended as follows:
a. In paragraph (b)(3)(i), the words ``, except turkey
hatcheries,'' would be removed.
b. In paragraph (b)(3)(ii), the words ``, except turkey flocks,''
would be removed.
c. In paragraph (b)(3)(viii), the words ``, other than turkey
flocks,'' would be removed.
d. In paragraph (b)(4), the words ``, other than turkey, waterfowl,
exhibition poultry, and game bird supply flocks,'' would be removed.
e. Paragraph (d)(1)(ii)(B) would be revised.
f. A new paragraph (h) would be added to read as follows:
Sec. 145.23 Terminology and classification; flocks and products.
* * * * *
(d) * * *
(1) * * *
(ii) * * *
(B) Mash feed may contain no animal protein other than an APPI
animal protein product supplement manufactured in pellet form and
crumbled: Provided, that mash feed may contain non-pelleted APPI animal
protein product supplements if the finished feed is treated with a
salmonella control product approved by the Food and Drug
Administration.
* * * * *
(h) 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 breeding chickens 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
[[Page 43309]]
determines that they have met one of the following requirements:
(1) It is a primary breeding flock in which minimum of 30 birds
have been tested negative for antibodies to avian influenza when more
than 4 months of age. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at
intervals of 90 days; or
(ii) A sample of fewer than 30 birds may be tested, and found to be
negative, at any one time if all pens are equally represented and a
total of 30 birds is tested within each 90-day period.
(2) It is a multiplier breeding flock in which minimum of 30 birds
have been tested negative for antibodies to avian influenza when more
than 4 months of age. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at
intervals of 180 days; or
(ii) A sample of fewer than 30 birds may be tested, and found to be
negative, at any one time if all pens are equally represented and a
total of 30 birds is tested within each 180-day period.
* * * * *
10. In Sec. 145.31, the definition of chicks would be revised to
read as follows:
Sec. 145.31 Definitions.
* * * * *
Chicks. Newly hatched chickens.
* * * * *
11. In Sec. 145.32, a new paragraph (d) would be added to read as
follows:
Sec. 145.32 Participation.
* * * * *
(d) Any nutritive material provided to chicks must be free of the
avian pathogens that are officially represented in the Plan disease
classifications listed in Sec. 145.10.
12. Section 145.33 would be amended as follows:
a. In paragraph (b)(3)(i), the words
``, except turkey hatcheries,'' would be removed.
b. In paragraph (b)(3)(ii), the words
``, except turkey flocks,'' would be removed.
c. In paragraph (b)(3)(viii), the words ``, other than turkey
flocks,'' would be removed.
d. In paragraph (b)(4), the words
``, other than turkey, waterfowl, exhibition poultry, and game bird
supply flocks,'' would be removed.
e. Paragraph (h)(1)(ii)(B) would be revised.
f. Paragraph (i)(1)(vi) would be amended by removing the words
``meconium and'' and adding the words ``meconium or'' in their place.
g. A new paragraph (l) would be added to read as follows:
Sec. 145.33 Terminology and classification; flocks and products.
* * * * *
(h) * * *
(1) * * *
(ii) * * *
(B) Mash feed may contain no animal protein other than an APPI/NMFS
animal protein product supplement manufactured in pellet form and
crumbled: Provided, that mash feed may contain non-pelleted APPI/NMFS
animal protein product supplements if the finished feed is treated with
a salmonella control product approved by the Food and Drug
Administration.
* * * * *
(l) 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 primary breeding chickens
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 they have met one of the following requirements:
(1) It is a primary breeding flock in which a minimum of 30 birds
have been tested negative for antibodies to avian influenza when more
than 4 months of age. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at
intervals of 90 days; or
(ii) A sample of fewer than 30 birds may be tested, and found to be
negative, at any one time if all pens are equally represented and a
total of 30 birds is tested within each 90-day period.
(2) It is a multiplier breeding flock in which minimum of 30 birds
have been tested negative for antibodies to avian influenza when more
than 4 months of age. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at
intervals of 180 days; or
(ii) A sample of fewer than 30 birds may be tested, and found to be
negative, at any one time if all pens are equally represented and a
total of 30 birds is tested within each 180-day period.
* * * * *
13. In Sec. 145.41, the definition of poults would be revised to
read as follows:
Sec. 145.41 Definitions.
* * * * *
Poults. Newly hatched turkeys.
14. In Sec. 145.42, a new paragraph (d) would be added to read as
follows:
Sec. 145.42 Participation.
* * * * *
(d) Any nutritive material provided to poults must be free of the
avian pathogens that are officially represented in the Plan disease
classifications listed in Sec. 145.10.
15. In Sec. 145.43, paragraphs (f)(3)(ii) and (f)(3)(iii) would be
revised to read as follows:
Sec. 145.43 Terminology and classification; flocks and products.
* * * * *
(f) * * *
(3) * * *
(ii) Initial feed for poults to 2 weeks of age must be manufactured
in pellet form. Initial feed may contain no animal protein other than
animal protein products produced under the Animal Protein Products
Industry (APPI) Salmonella Education/Reduction Program or the Fishmeal
Inspection Program of the National Marine Fisheries Service (NMFS).
Finished feed must be treated with a Food and Drug Administration (FDA)
approved salmonella control product at FDA-approved levels.
(iii) Succeeding feed for turkeys 2 weeks or older must be either:
(A) Pelleted feed that meets the requirements of paragraph
(f)(3)(ii) of this section; or
(B) Mash feed that contains no animal protein products; or
(C) Mash feed that contains an APPI/NMFS animal protein products
supplement that has been manufactured in pellet form and crumbled.
Finished feed must be treated with an FDA-approved salmonella control
product at FDA-approved levels.
* * * * *
16. In Sec. 145.44, a new paragraph (e) would be added to read as
follows:
Sec. 145.44 Terminology and classification; States.
* * * * *
(e) U.S. M. Meleagridis Clean State, Turkeys. (1) A State will be
declared a U.S. M. Meleagridis Clean State, Turkeys, if the Service
determines that:
(i) No Mycoplasma meleagridis is known to exist nor to have existed
in turkey breeding flocks in production within the State during the
preceding 12 months;
(ii) All turkey breeding flocks in production are tested and
classified as U.S. M. Meleagridis Clean or have met equivalent
requirements for M. meleagridis control under official supervision;
(iii) All turkey hatcheries within the State only handle products
that are classified as U.S. M. Meleagridis Clean
[[Page 43310]]
or have met equivalent requirements for M. meleagridis control under
official supervision;
(iv) All shipments of products from turkey breeding flocks other
than those classified as U.S. M. Meleagridis Clean, or equivalent, into
the State are prohibited;
(v) All persons performing poultry disease diagnostic services
within the State are required to report to the Official State Agency
within 48 hours the source of all turkey specimens that have been
identified as being infected with M. meleagridis;
(vi) All reports of M. meleagridis infection in turkeys are
promptly followed by an investigation by the Official State Agency to
determine the origin of the infection; and
(vii) All turkey breeding flocks found to be infected with M.
meleagridis are quarantined until marketed under supervision of the
Official State Agency.
(2) The Service may revoke the State's classification as a U.S. M.
Meleagridis Clean State, Turkeys, if any of the conditions described in
paragraph (d)(1) of this section are discontinued. The Service will not
revoke the State's classification as a U.S. M. Meleagridis Clean State,
Turkeys, until it has conducted an investigation and the Official State
Agency has been given an opportunity for a hearing in accordance with
rules of practice adopted by the Administrator.
* * * * *
17. In Sec. 145.52, a new paragraph (d) would be added to read as
follows:
Sec. 145.52 Participation.
* * * * *
(d) Any nutritive material provided to baby poultry must be free of
the avian pathogens that are officially represented in the Plan disease
classifications listed in Sec. 145.10.
Sec. 145.53 [Amended]
18. In Sec. 145.53, paragraph (b) would be amended as follows:
a. In paragraph (b)(3)(i), the words ``, except turkey
hatcheries,'' would be removed.
b. In paragraph (b)(3)(ii) the words ``, except turkey flocks,''
would be removed.
c. In paragraph (b)(3)(viii), the words ``, other than turkey
flocks,'' would be removed.
d. In paragraph (b)(4), the words ``, other than turkey flocks,''
would be removed.
19. The subpart heading for subpart F would be revised to read as
follows:
Subpart F--Special Provisions for Ostrich, Emu, Rhea, and Cassowary
Breeding Flocks and Products
20. In 145.61, a definition of chicks would be added, in
alphabetical order, to read as follows:
Sec. 145.61 Definitions.
* * * * *
Chicks. Newly hatched ostriches, emus, rheas, or cassowaries.
* * * * *
21. In Sec. 145.62, the introductory text would be amended by
adding the words ``emus, rheas, and cassowaries,'' immediately after
the word ``ostriches,'' and a new paragraph (c) would be added to read
as follows:
Sec. 145.62 Participation.
* * * * *
(c) Any nutritive material provided to chicks must be free of the
avian pathogens that are officially represented in the Plan disease
classifications listed in Sec. 145.10.
Sec. 145.63 [Amended]
22. In Sec. 145.63, paragraph (a)(2) would be amended by adding the
words ``, emus, rheas, or cassowaries'' immediately after the word
``ostriches''.
PART 147--AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN
23. The authority citation for part 147 would continue to read as
follows:
Authority: 7 U.S.C. 429; 7 CFR 2.22, 2.80, and 371.2(d).
Sec. 147.4 [Removed and reserved]
24. Section 147.4 would be removed and reserved.
25. In Sec. 147.6, paragraph (a)(14) would be revised to read as
follows:
Sec. 147.6 Procedure for determining the status of flocks reacting to
tests for Mycoplasma gallisepticum, Mycoplasma synoviae, and Mycoplasma
meleagridis.
* * * * *
(a) * * *
(14) If the in vivo bio-assay, PCR-based procedures, or culture
procedures are positive, the flock will be considered infected.
However, the following considerations may apply:
(i) In PCR-positive flocks for which there are other negative
mycoplasma test results, the flock's mycoplasma status should be
confirmed through either seroconversion or culture isolation of the
organism, or through both methods, before final determination of the
flock's status is made.
(ii) In flocks for which only the bio-assay is positive, additional
in vivo bio-assay, PCR-based procedures, or cultural examinations may
be conducted by the Official State Agency before final determination of
the flock's status is made.
* * * * *
Secs. 147.11, 147.12, 147.14, 147.15, 147.16 [Footnotes redesignated]
26. In Secs. 147.11, 147.12, 147.14, 147.15, 147.16, footnotes 6
through 22 and their references would be redesignated as footnotes 7
through 23, respectively.
27. A new Sec. 147.9 would be added to read as follows:
Sec. 147.9 Standard test procedures for avian influenza.
(a) The agar gel immunodiffusion (AGID) test should be considered
the basic screening test for antibodies to Type A influenza viruses.
The AGID test is used to detect circulating antibodies to Type A
influenza group-specific antigens, namely the ribonucleoprotein (RNP)
and matrix (M) proteins. Therefore, this test will detect antibodies to
all influenza A viruses, regardless of subtype. The AGID test can also
be used as a group-specific test to identify isolates as Type A
influenza viruses. The method used is similar to that described by
Beard.\6\ The basis for the AGID test is the concurrent migration of
antigen and antibodies toward each other through an agar gel matrix.
When the antigen and specific antibodies come in contact, they combine
to form a precipitate that is trapped in the gel matrix and produces a
visible line. The precipitin line forms where the concentration of
antigen and antibodies is optimum. Differences in the relative
concentration of the antigen or antibodies will shift the location of
the line towards the well with the lowest concentration or result in
the absence of a precipitin line. Electrolyte concentration, pH,
temperature, and other variables also affect precipitate formation.
---------------------------------------------------------------------------
\6\ Beard, C.W. Demonstration of type-specific influenza
antibody in mammalian and avian sera by immunodifussion Bull. Wld.
Hlth. Orig. 42:779-785. 1970.
---------------------------------------------------------------------------
(1) Materials needed.
(i) Refrigerator (4 deg.C).
(ii) Freezer (-20 deg.C).
(iii) Incubator or airtight container for room temperature
(25 deg.C) incubations.
(iv) Autoclave.
(v) Hot plate/stirrer and magnetic stir bar (optional).
(vi) Vacuum pump.
(vii) Microscope illuminator or other appropriate light source for
viewing results.
[[Page 43311]]
(viii) Immunodiffusion template cutter, seven-well pattern (a
center well surrounded by six evenly spaced wells). Wells are 5.3 mm in
diameter and 2.4 mm apart.
(ix) Top loading balance (capable of measuring 0.1 gm differences).
(x) Pipetting device capable of delivering 50 l portions.
(xi) Common laboratory supplies and glassware--Erlenmeyer flasks,
graduated cylinders, pipettes, 100 x 15 mm or 60 x 15 mm petri
dishes, flexible vacuum tubing, side-arm flask (500 mL or larger), and
a 12-or 14-gauge blunt-ended cannula.
(2) Reagents needed.
(i) Phosphate buffered saline (PBS), 0.01M, pH 7.2 (NVSL media
#30054 or equivalent).
(ii) Agarose (Type II Medium grade, Sigma Chemical Co. Cat.# A-6877
or equivalent).
(iii) Avian influenza AGID antigen and positive control antiserum
approved by the Department and the Official State Agency.
(iv) Strong positive, weak positive, and negative control antisera
approved by the Department and the Official State Agency (negative
control antisera optional).
(3) Preparing the avian influenza AGID agar.
(i) Weigh 9 gm of agarose and 80 gm of NaCl and add to 1 liter of
PBS (0.01 M, pH 7.2) in a 2 liter Erlenmeyer flask.
(ii) To mix the agar, either:
(A) Autoclave the mixture for 10 minutes and mix the contents by
swirling after removing from the autoclave to ensure a homogeneous
mixture of ingredients; or
(B) Dissolve the mixture by bringing to a boil on a hot plate using
a magnetic stir bar to mix the contents in the flask while heating.
After boiling, allow the agar to cool at room temperature
(25 deg.C) for 10 to 15 minutes before dispensing into
petri plates.
(iii) Agar can be dispensed into small quantities (daily working
volumes) and stored in airtight containers at 4 deg.C for several
weeks, and melted and dispensed into plates as needed.
Note: Do not use agar if microbial contamination or precipitate
is observed.
(4) Performing the AGID. (i) Detection of serum antibodies.
(A) Dispense 15 to 17 mL of melted agar into a 100 x 15 mm petri
plate or 5 to 6 mL agar into a 60 x 15 mm petri plate using a 25 mL
pipette. The agar thickness should be approximately 2.8 mm.
(B) Allow plates to cool in a relatively dust-free environment with
the lids off to permit the escape of water vapor. The lids should be
left off for at least 15 minutes, but not longer than 30 minutes, as
electrolyte concentration of the agar may change due to evaporation and
adversely affect formation of precipitin lines.
Note: Plates should be used within 24 hours after they are
poured.
(C) Record the sample identification, reagent lot numbers, test
date, and identification of personnel performing and reading the test.
(D) Using the template, cut the agar after it has hardened. Up to
seven template patterns can be cut in a 100 x 15 mm plate and two
patterns can be cut in a 60 x 15 mm plate.
(E) Remove the agar plugs by aspiration with a 12-to 14-gauge
cannula connected to a side arm flask with a piece of silicone or
rubber tubing that is connected to a vacuum pump with tubing. Adjust
the vacuum so that the agar surrounding the wells is not disturbed when
removing the plugs.
(F) To prepare the wells, either:
(1) Place 50 l of avian influenza AGID antigen in the
center well using a micropipette with an attached pipette tip. Place 50
l AI AGID positive control antiserum in each of two opposite
wells, and add 50 l per well of test sera in the four
remaining wells. This arrangement provides a positive control line on
one side of the test serum, thus providing for the development of lines
of identity (see figure 1); or
(2) Place 50 l AI AGID positive control antiserum in each
of three alternate peripheral wells, and add 50 l per well of
test sera in the three remaining wells. This arrangement provides a
positive control line on each side of the test serum, thus providing
for the development of lines of identity on both sides of each test
serum (see figure 2).
Note: A pattern can be included with positive, weak positive,
and negative reference serum in the test sera wells to aid in the
interpretation of results (see figure 3).
(G) Cover each plate after filling all wells and allow the plates
to incubate for 24 hours at room temperature (25 deg.C) in
a closed chamber to prevent evaporation. Humidity should be provided by
placing a damp paper towel in the incubation chamber. Note: Temperature
changes during migration may lead to artifacts.
(ii) Interpretation of test results.
(A) Remove the lid and examine reactions from above by placing the
plate(s) over a black background, and illuminate the plate with a light
source directed at an angle from below. A microscope illuminator works
well and allows for varying intensities of light and positions.
(B) The type of reaction will vary with the concentration of
antibody in the sample being tested. The positive control serum line is
the basis for reading the test. If the line is not distinct, the test
is not valid and must be repeated. The following types of reactions are
observed (see figure 3):
(1) Negative reaction. The control lines continue into the test
sample well without bending or with a slight bend away from the antigen
well and toward the positive control serum well.
(2) Positive reaction. The control lines join with, and form a
continuous line (line of identity) with, the line between the test
serum and antigen. The location of the line will depend on the
concentration of antibodies in the test serum. Weakly positive samples
may not produce a complete line between the antigen and test serum but
may only cause the tip or end of the control line to bend inward toward
the test well.
(3) Non-specific lines. These lines occasionally are observed
between the antigen and test serum well. The control lines will pass
through the non-specific line and continue on into the test serum well.
The non-specific line does not form a continuous line with positive
control lines.
BILLING CODE 3410-34-U
[[Page 43312]]
[GRAPHIC] [TIFF OMITTED] TP10AU99.020
[[Page 43313]]
[GRAPHIC] [TIFF OMITTED] TP10AU99.021
BILLING CODE 3410-34-C
[[Page 43314]]
(b) The enzyme-linked immunosorbent assay (ELISA) may be used as a
screening test for avian influenza. Use only federally licensed ELISA
kits and follow the manufacturer's instructions. All ELISA-positive
serum samples must be confirmed with the AGID test conducted in
accordance with paragraph (a) of this section.
Sec. 147.11 [Amended]
28. Section 147.11 would be amended as follows:
a. In paragraph (b)(2)(iii) the words ``A group D colony lift assay
may be utilized to signal the presence of the hard-to-detect group D
salmonella colonies on agar culture plates.'' would be added after the
final sentence.
b. In paragraph (b)(2)(v), the words ``at the National Veterinary
Services Laboratory'' would be removed.
29. A new Sec. 147.18 would be added to read as follows:
Sec. 147.18 Chick meconium testing procedure for salmonella.
Procedure:
(a) Record the date, source, and flock destination on the
``Meconium Worksheet.''
(b) Shake each plastic bag of meconium until a uniform consistency
is achieved.
(c) Transfer a 25 gm sample of meconium to a sterile container. Add
225 mL of a preenrichment broth to each sample (this is a 1:10
dilution), mix gently, and incubate at 37 deg.C for 18-24 hours.
(d) Enrich the sample with selective enrichment broth for 24 hours
at 42 deg.C.
(e) Streak the enriched sample onto brilliant green-Novobiocin
(BGN) agar and xylose-lysine-tergitol 4 (XLT4) agar.
(f) Incubate both plates at 35 deg.C for 24 hours and process
suspect salmonella colonies according to Sec. 147.11.
30. In Sec. 147.43, paragraphs (d)(1) through (d)(4) would be
redesignated as paragraphs (d)(3) through (d)(6), respectively, and new
paragraphs (d)(1), (d)(2), (d)(7), and (d)(8) would be added to read as
follows:
Sec. 147.43 General Conference Committee.
* * * * *
(d) * * *
(1) Advise and make recommendations to the Department on the
relative importance of maintaining, at all times, adequate departmental
funding for the NPIP to enable the Senior Coordinator and staff to
fully administer the provisions of the Plan.
(2) Advise and make yearly recommendations to the Department with
respect to the NPIP budget well in advance of the start of the
budgetary process.
* * * * *
(7) Serve as a direct liaison between the National Poultry
Improvement Plan and the United States Animal Health Association.
(8) Advise and make recommendations to the Department regarding
NPIP involvement or representation at poultry industry functions and
activities as deemed necessary or advisable for the purposes of the
NPIP.
Sec. 147.45 [Amended]
31. Section 147.45 would be amended by removing the words ``and E''
and adding the words ``E, and F'' in their place.
32. In Sec. 145.46, the introductory text of paragraph (a) would be
amended by removing the word ``four'' and adding the word ``five'' in
its place, and a new paragraph (a)(5) would be added to read as
follows:
Sec. 147.46 Committee consideration of proposed changes.
(a) * * *
(5) Ostriches, emus, rheas, and cassowaries.
* * * * *
Done in Washington, DC, this 4th day of August 1999.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-20540 Filed 8-9-99; 8:45 am]
BILLING CODE 3410-34-U