[Federal Register Volume 61, Number 56 (Thursday, March 21, 1996)]
[Rules and Regulations]
[Pages 11515-11525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6834]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 82, 145, and 147
[Docket No. 94-091-2]
National Poultry Improvement Plan and Auxiliary Provisions
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the National Poultry Improvement Plan (the
Plan) and its auxiliary provisions by providing new or modified
administrative and testing procedures for Plan participants and
participating flocks. These changes, which were voted on and approved
by the voting delegates at the Plan's 1992 and 1994 National Plan
Conferences, will keep the provisions of the Plan current with changes
in the poultry industry, reduce paperwork requirements for some Plan
participants, establish new program classifications, and allow the use
of new sampling and laboratory procedures.
EFFECTIVE DATE: April 22, 1996.
FOR FURTHER INFORMATION CONTACT: Mr. Andrew R. Rhorer, Senior
Coordinator, Poultry Improvement Staff, National Poultry Improvement
Plan, Veterinary Services, APHIS, USDA, 1500 Klondike Road, Suite A-
102, Conyer, GA 30207; (404) 922-3496.
SUPPLEMENTARY INFORMATION:
Background
The National Poultry Improvement Plan (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 B, which
provide for certain testing, restrictions on movement, and other
restriction 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. Sanitation Monitored''
under the Plan or they meet the requirements of a State classification
plan that the Administrator of the Animal and Plant Health Inspection
Service (APHIS) has determined to be equivalent to the Plan, in
accordance with 9 CFR 145.23(d).
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. APHIS amends these
provisions from time to time to incorporate new scientific information
and technologies into the Plan.
On July 7, 1995, we published in the Federal Register (60 FR 35343-
35353, Docket No. 94-091-1) a proposal to amend the regulations to:
1. Require the ratio of male to female birds in representative
samples taken from certain flocks for pullorum-typhoid testing to
reflect the ratio of male to female birds in the flock from which the
sample was taken;
2. Alter the number of birds serologically monitored for Mycoplasma
gallisepticum and M. synoviae in egg-type and meat-type chicken
breeding flocks;
3. Allow the use of a federally licensed enzyme-linked
immunosorbent assay (ELISA) test for the serological screening of egg-
type chickens in the ``U.S. S. Enteritidis Monitored'' program;
4. Allow the use of fishmeal as an animal protein source for meat-
type breeding chickens and turkey breeding flocks;
5. Establish a new ``U.S. S. Enteritidis Clean'' classification for
primary meat-type chicken breeding flocks;
6. Establish a new ``U.S. M. Synoviae Clean State'' classification
for turkeys;
[[Page 11516]]
7. Provide alternative reporting methods for participating
waterfowl, exhibition poultry, and game bird flocks;
8. Establish a maximum number of positive samples for Mycoplasma
gallisepticum or M. synoviae to be examined using the hemagglutination
inhibition (HI) and/or serum plate dilution (SPD) tests;
9. Allow the use of a colony lift assay as a supplemental screening
test to aid in the detection of group D salmonella suspect colonies on
selective and non-selective agar culture plates;
10. Establish new procedures for collecting environmental samples
and cloacal swabs from egg-type and meat-type chicken flocks and
waterfowl, exhibition poultry, and game bird flocks for bacteriological
examination;
11. Provide a laboratory protocol for the bacteriological
examination of baby chicks from egg-type and meat-type chicken flocks
and waterfowl, exhibition poultry, and game bird flocks; and
12. Modify the composition of the Plan's General Conference
Committee.
We also proposed to amend several other sections of the regulations
to reflect the proposed changes discussed above or to reflect a change
made in a previously published final rule.
We solicited comments concerning our proposal for 60 days ending
September 5, 1995. We received three comments by that date. They were
from a State agriculture department, a college of veterinary medicine,
and a State egg quality assurance program. We carefully considered all
of the comments we received. They are discussed below.
One commenter pointed out that laboratory procedure for the
bacteriological examination of cull chicks should have specified that
the 25 randomly selected 1- to 5-day-old chicks must be chicks that
have not been housed with any other poultry. The commenter correctly
noted that the ``have not been housed'' provision was part of the
laboratory procedure that was approved by the voting delegates at the
Plan's 1994 National Plan Conference. We agree with the commenter and
acknowledge that the words in question were inadvertently omitted from
the text of the proposed rule. We have, therefore, added the words
``that have not been placed in a brooding house'' to paragraph (a) of
new Sec. 147.17.
Another commenter fully supported several specific aspects of the
proposed rule, including the addition of Sec. 147.17, the laboratory
procedure recommended for the bacteriological examination of cull
chicks for salmonella. The commenter particularly applauded the
inclusion of the bursa of Fabricius in the organ pool for such
examinations, and recommended that the other testing protocols in part
147 be amended to include the bursa of Fabricius in any organ pools
collected for examination. Because the commenter's suggested amendments
were not within the scope of the proposed rule, we cannot make such
changes in this final rule. However, the commenter's recommendation
will be forwarded to the Plan's General Conference Committee for
consideration and could be included in a future rulemaking.
The third commenter was concerned about the use of the word
``clean'' in the ``U.S. S. Enteritidis Clean'' classification.
Specifically, he stated that the word ``clean'' in the classification
would lead one to believe that a flock classified as such is negative
for Salmonella enteritidis serotype Enteritidis (SE), but the testing
procedures within the classification allow a flock with an SE-positive
environment and one SE-positive bird from a 25-bird sample to still be
eligible for ``clean'' status if no SE was recovered from a second 25-
bird sample. To the commenter, the SE-positive environment and bird
were indicative of at least low levels of SE infection in the flock,
even if no SE was recovered from a second 25-bird sample. The commenter
concluded that the classification of a flock from which SE has been
isolated from an environmental sample or in which one bird has been
found to be SE-positive as ``U.S. S. Enteritidis Clean'' is misleading
and could result in the spread of SE through infected chicks.
As we stated in the proposed rule, the introductory text of
Sec. 145.33(h) provides that the ``U.S. S. Enteritidis Clean''
classification is intended for primary meat-type breeders who wish to
assure their customers that the chicks produced are certified free of
SE; the ``clean'' designation does not mean that the entire flock has
been conclusively shown to be negative for SE. The regulations in
Sec. 145.33(h) require that environmental samples be collected once the
flock reaches 4 months of age, then every 30 days thereafter. If SE is
isolated from an environmental sample, 25 randomly selected birds from
the flock must be bacteriologically examined for SE. If only one of the
25 birds is found positive for SE, there is the possibility that there
was some cross-contamination in the laboratory that conducted the
tests. For that reason, we included the provision that allows the Plan
participant to request the bacteriological examination of a second 25-
bird sample if only one bird from the first sample was SE-positive. The
testing of a 25-bird sample is not the only action that must be taken
after SE is isolated in an environmental sample, however; the
regulations also require that blood samples from 300 birds be
officially tested with pullorum antigen every 30 days with no positive
samples found. We believe that this monthly serologic testing of at
least 300 birds will be sufficient to detect the low levels of SE
infection that the commenter feared might remain undetected through the
testing of 25 or 50 birds, so we have made no change in this final rule
based on that comment.
Therefore, based on the rationale set forth in the proposed rule
and in this document, we are adopting the provisions of the proposal as
a final rule, with the changes discussed in this document and other
minor changes for clarity and consistency and to correct typographical
errors.
Executive Order 12866 and Regulatory Flexibility Act
This 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 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 30th and
31st Biennial Conferences. The changes will keep the provisions of the
Plan current with changes in the poultry industry, reduce paperwork
requirements for some Plan participants, establish new program
classifications, and allow the use of new sampling and laboratory
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. Several of the
recommendations in this rule, such as the serological sampling of male
meat-type birds for pullorum-typhoid and the use of fishmeal as a
protein source, are already practiced by the industry. Other changes,
such as the addition of a laboratory protocol for the bacteriological
examination of baby chicks, provide guidelines for practices that may
not currently be in use but are recognized as being potentially
beneficial for the industry. In all cases, the changes have been
generated by the industry itself with the goal of reducing disease risk
and increasing product marketability.
[[Page 11517]]
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.
The only change in this document that will entail additional costs
for some producers is the creation of the ``U.S. S. Enteritidis Clean''
classification for primary meat-type chicken breeding flocks. However,
we expect that any additional costs associated with the new
classification will be slight in comparison to the expected increase in
U.S. poultry exports, particularly to countries that require strict
Salmonella enteritidis testing of poultry.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action will
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 12778
This rule has been reviewed under Executive Order 12778, Civil
Justice Reform. This rule: (1) Preempts all State and local laws and
regulations that are in conflict with this rule; (2) has no retroactive
effect; and (3) does not require administrative proceedings before
parties may file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.), the information collection or recordkeeping requirements
included in this rule have been approved by the Office of Management
and Budget (OMB) under OMB control number 0579-0007.
List of Subjects
9 CFR Part 82
Animal diseases, Poultry and poultry products, Quarantine,
Reporting and recordkeeping requirements, Transportation.
9 CFR Parts 145 and 147
Animal diseases, Poultry and poultry products, Reporting and
recordkeeping requirements.
Accordingly, 9 CFR parts 82, 145, and 147 are amended as follows:
PART 82--EXOTIC NEWCASTLE DISEASE IN ALL BIRDS AND POULTRY:
PSITTACOSIS AND ORNITHOSIS IN POULTRY: POULTRY DISEASE CAUSED BY
SALMONELLA ENTERITIDIS SEROTYPE ENTERITIDIS
1. The authority citation for part 82 is revised to read as
follows:
Authority: 21 U.S.C. 111-113, 115, 117, 120, 123-126, 134a,
134b, and 134f; 7 CFR 2.18, 2.22, 2.53, 2.80, and 371.2(d).
Sec. 82.30 [Amended]
2. In Sec. 82.30, in the definition of certified Salmonella
enteritidis serotype enteritidis tested free flocks, the words
``Sanitation Monitored'' are removed and the words ``S. Enteritidis
Monitored'' added in their place.
Sec. 82.34 [Amended]
3. In Sec. 82.34, the words ``Sanitation Monitored'' are removed
and the words ``S. Enteritidis Monitored'' added in their place.
PART 145--NATIONAL POULTRY IMPROVEMENT PLAN
4. The authority citation for part 145 continues to read as
follows:
Authority: 7 U.S.C. 429; 7 CFR 2.22, 2.80, and 371.2(d).
5. In Sec. 145.10, paragraphs (g) and (h) are revised and new
paragraphs (m) and (n) are added to read as follows:
Sec. 145.10 Terminology and classification; flocks, products, and
States.
* * * * *
(g) U.S. Pullorum-Typhoid Clean State. (See Sec. 145.24(a),
Sec. 145.34(a), Sec. 145.44(a), and Sec. 145.54(a).)
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(h) U.S. Pullorum-Typhoid Clean State, Turkeys. (See
Sec. 145.44(b).)
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[[Page 11519]]
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* * * * *
(m) U.S. S. Enteritidis Clean. (See Sec. 145.33(h).)
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(n) U.S. M. Synoviae Clean State, Turkeys. (See Sec. 145.44(d).)
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6. Section 145.14 is amended by revising the introductory text
immediately after the third sentence (which ends with the words ``in
the house'') to read as follows:
Sec. 145.14 Blood testing.
* * * The ratio of male to female birds in representative samples
of birds from meat-type chicken, waterfowl,
[[Page 11520]]
exhibition poultry, and game bird flocks must be the same as the ratio
of male to female birds in the flock. In houses containing fewer than
30 birds, all birds in the house must be tested.
* * * * *
7. Section 145.23 is amended as follows:
a. Paragraph (c)(1)(i) is amended by removing the words ``with the
approval of the Official State Agency and the concurrence of the
Service, provided that a minimum'' and adding the words ``if all pens
are equally represented and a total'' in their place.
b. Paragraph (c)(1)(ii)(A) is revised to read as set forth below.
c. In paragraph (d)(1)(vii), the first sentence is revised to read
as set forth below.
d. Paragraph (e)(1)(i) is amended by removing the words ``, with
the approval of the Official State Agency and the concurrence of the
Service, provided that a minimum'' and adding the words ``if all pens
are equally represented and a total'' in their place.
e. Paragraph (e)(1)(ii)(A) is revised to read as set forth below.
Sec. 145.23 Terminology and classification; flocks and products.
* * * * *
(c) * * *
(1) * * *
(ii) * * *
(A) At intervals of not more than 90 days, 75 birds from the flock
shall be tested, Provided, that fewer than 75 birds from the flock may
be tested at any one time if all pens are equally represented and a
total of at least 75 birds from the flock is tested within each 90-day
period; or
* * * * *
(d) * * *
(1) * * *
(vii) Blood samples from 300 non-vaccinated birds as described in
paragraph (d)(1)(vi) of this section shall be tested with either
pullorum antigen or by a federally licensed Salmonella enteritidis
enzyme-linked immunosorbent assay (ELISA) test when the flock is more
than 4 months of age. * * *
* * * * *
(e) * * *
(1) * * *
(ii) * * *
(A) At intervals of not more than 90 days, 75 birds from the flock
shall be tested: Provided, That fewer than 75 birds from the flock may
be tested at any one time if all pens are equally represented and a
total of at least 75 birds from the flock is tested within each 90-day
period; or
* * * * *
8. Section 145.33 is amended as follows:
a. Paragraph (c)(1)(i) is amended by removing the words ``with the
approval of the Official State Agency and the concurrence of the
Service, provided that a minimum'' and adding the words ``if all pens
are equally represented and a total'' in their place.
b. Paragraph (c)(1)(ii)(A) is revised to read as set forth below.
c. In paragraph (d)(1)(iii), the first sentence is amended by
removing the word ``should'' and adding the word ``shall'' in its
place, and by adding the words ``or the Fishmeal Inspection Program of
the National Marine Fisheries Service'' immediately before the period.
d. Paragraph (d)(1)(iv) is amended by removing the word ``should''
and adding the word ``shall'' in its place, and by adding the words
``or the Fishmeal Inspection Program of the National Marine Fisheries
Service'' immediately before the semicolon.
e. Paragraph (e)(1)(i) is amended by removing the words ``, with
the approval of the Official State Agency and the concurrence of the
Service, provided that a minimum'' and adding the words ``if all pens
are equally represented and a total'' in their place.
f. Paragraph (e)(1)(ii)(A) is revised to read as set forth below.
g. A new paragraph (h) is added to read as set forth below.
Sec. 145.33 Terminology and classification; flocks and products.
* * * * *
(c) * * *
(1) * * *
(ii) * * *
(A) At intervals of not more than 90 days, 75 birds from the flock
shall be tested, Provided, That fewer than 75 birds from the flock may
be tested at any one time if all pens are equally represented and a
total of at least 75 birds from the flock is tested within each 90-day
period; or
* * * * *
(e) * * *
(1) * * *
(ii) * * *
(A) At intervals of not more than 90 days, 75 birds from the flock
shall be tested: Provided, That fewer than 75 birds from the flock may
be tested at any one time if all pens are equally represented and a
total of at least 75 birds from the flock is tested within each 90-day
period; or
* * * * *
(h) U.S. S. Enteritidis Clean. This classification is intended for
primary meat-type breeders wishing to assure their customers that the
chicks produced are certified free of Salmonella enteritidis.
(1) A flock and the hatching eggs and chicks produced from it shall
be eligible for this classification if they meet the following
requirements, as determined by the Official State Agency:
(i) The flock originated from a U.S. S. Enteritidis Clean flock, or
meconium from the chicks and a sample of chicks that died within 7 days
after hatching have been examined bacteriologically for S. enteritidis
at an authorized laboratory and any group D salmonella samples have
been serotyped.
(ii) All feed fed to the flock meets the following requirements:
(A) Pelletized feed contains either no animal protein or only
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. The
protein products must have a minimum moisture content of 14.5 percent
and must have been heated throughout to a minimum temperature of 190
deg.F, or to a minimum temperature of 165 deg.F for at least 20
minutes, or to a minimum temperature of 184 deg.F under 70 lbs.
pressure during the manufacturing process;
(B) Mash feed contains either no animal protein or only animal
protein product supplements manufactured in pellet form and crumbled;
and
(C) All feed is stored and transported in such a manner as to
prevent possible contamination.
(iii) The flock is maintained in compliance with Secs. 147.21,
147.24(a), and 147.26 of this chapter.
(iv) Environmental samples, as described in Sec. 147.12 of this
chapter, are collected from the flock by an Authorized Agent when the
flock reaches 4 months of age and every 30 days thereafter. The
environmental samples shall be examined bacteriologically for group D
salmonella at an authorized laboratory, and cultures from group D
positive samples shall be serotyped.
(v) Blood samples from 300 birds from the flock are officially
tested with pullorum antigen when the flock is at least 4 months of
age. All birds with positive or inconclusive reactions, up to a maximum
of 25 birds, shall be submitted to an authorized laboratory and
examined for the presence of group D salmonella in accordance with
Secs. 147.10 and 147.11 of this chapter. Cultures from group D positive
samples shall be serotyped.
(vi) Hatching eggs produced by the flock are collected as quickly
as possible, are handled as described in
[[Page 11521]]
Sec. 147.22 of this chapter, and are sanitized or fumigated.
(vii) Hatching eggs produced by the flock are incubated in a
hatchery that is in compliance with the recommendations in Secs. 147.23
and 147.24(b) of this chapter, and the hatchery must have been
sanitized either by a procedure approved by the Official State Agency
or by fumigation.
(2) If Salmonella enteritidis serotype Enteritidis (SE) is isolated
from a specimen taken from a bird in the flock, except as provided in
paragraph (h)(3) of this section, the flock shall not be eligible for
this classification.
(3) If SE is isolated from an environmental sample collected from
the flock in accordance with in paragraph (h)(1)(iv) of this section,
25 randomly selected live birds from the flock must be
bacteriologically examined for SE as described in Sec. 147.11 of this
chapter. If only one bird from the 25-bird sample is found positive for
SE, the participant may request bacteriological examination of a second
25-bird sample from the flock. If no SE is recovered from any of the
specimens in the second sample, the flock will be eligible for the
classification and will remain eligible for this classification if the
flock is tested in accordance with paragraph (h)(1)(v) of this section
each 30 days and no positive samples are found.
(4) In order for a hatchery to sell products of this
classification, all products handled by the hatchery must meet the
requirements of this paragraph.
(5) This classification may be revoked by the Official State Agency
if the participant fails to follow recommended corrective measures. The
Official State Agency shall not revoke the participant's classification
until the participant has been given an opportunity for a hearing in
accordance with rules of practice adopted by the Official State Agency.
(Approved by the Office of Management and Budget under control number
0579-0007)
Sec. 145.43 [Amended]
9. In Sec. 145.43, paragraph (f)(3)(ii) is amended by adding the
words ``or the Fishmeal Inspection Program of the National Marine
Fisheries Service'' immediately before the period.
10. In Sec. 145.44, a new paragraph (d) is added to read as
follows:
Sec. 145.44 Terminology and classification; States.
* * * * *
(d) U.S. M. Synoviae Clean State, Turkeys. (1) A State will be
declared a U.S. M. Synoviae Clean State, Turkeys, if the Service
determines that:
(i) No Mycoplasma synoviae 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. Synoviae Clean or have met equivalent
requirements for M. synoviae control under official supervision;
(iii) All turkey hatcheries within the State only handle products
that are classified as U.S. M. Synoviae Clean or have met equivalent
requirements for M. synoviae control under official supervision;
(iv) All shipments of products from turkey breeding flocks other
than those classified as U.S. M. Synoviae 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. synoviae;
(vi) All reports of M. synoviae 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.
synoviae 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.
Synoviae Clean State, Turkeys, if any of the conditions described in
paragraph (d)(1) of this section are discontinued. The Service shall
not revoke the State's classification as a U.S. M. Synoviae 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 of the
Service.
11. In Sec. 145.52, a new paragraph (c) is added to read as
follows:
Sec. 145.52 Participation.
* * * * *
(c) Subject to the approval of the Service and the Official State
Agencies in the importing and exporting States, participating flocks
may report poultry sales to importing States by using printouts of
computerized monthly shipping and receiving reports in lieu of VS Form
9-3, ``Report of Sales of Hatching Eggs, Chicks, and Poults.''
PART 147--AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN
12. The authority citation for part 147 continues to read as
follows:
Authority: 7 U.S.C. 429; 7 CFR 2.22, 2.80, and 371.2(d).
13. In Sec. 147.5, footnote 4 is amended by removing the words
``Animal and Plant Health Inspection Service, Veterinary Services,
Operational Support, 4700 River Road Unit 33, Riverdale, Maryland
20737-1231'' and adding the words ``National Poultry Improvement Plan,
Veterinary Services, APHIS, USDA, 1500 Klondike Road, Suite A-102,
Conyer, GA 30207'' in their place.
14. Section 147.6 is amended as follows:
a. In Sec. 147.6, paragraph (b)(2) is amended by adding two new
sentences at the end of the paragraph to read as set forth below.
b. In paragraph (b)(8), the words ``on the retest'' are added
immediately after the word ``positive''.
Sec. 147.6 Procedure for determining the status of flocks reacting to
tests for Mycoplasma gallisepticum, Mycoplasma synoviae, and Mycoplasma
meleagridis.
* * * * *
(b) * * *
(2) * * * Provided, that for egg-type and meat-type chicken and
waterfowl, exhibition poultry, and game bird flocks, if more than 50
percent of the samples are positive for either Mycoplasma
gallisepticum, M. synoviae, or both, the HI and/or the SPD test shall
be conducted on 10 percent of the positive samples or 25 positive
samples, whichever is greater. The results of the HI and/or SPD tests
must be followed by the action prescribed in paragraphs (b)(3), (b)(4),
and (b)(5) of this section.
* * * * *
15. Section 147.11 is amended as follows:
a. Paragraph (a)(3) is amended by adding a new sentence at the end
of the paragraph to read as set forth below.
b. In paragraph (a)(4), the last sentence is amended by adding the
words ``and paragraph (a)(5) of this section'' immediately after the
words ``illustration 2'', and by adding the words ``, and a colony lift
assay to aid in the detection of group D salmonella colonies''
immediately after the word ``XLT4''.
c. Paragraph (a)(5) is revised as set forth below.
d. At the end of paragraph (a)(6), illustration 2 is revised as set
forth below.
Sec. 147.11 Laboratory procedure recommended for the bacteriological
examination of salmonella.
(a) * * *
(3) * * * As a supplemental procedure, a colony lift assay may also
[[Page 11522]]
be used as a screening test to aid in the detection of group D
salmonella suspect colonies on selective and nonselective agar culture
plates.
* * * * *
(5) As a supplement to the standard colony pick to triple sugar-
iron (TSI) and lysine-iron (LI) agar slants, a group D colony lift
assay may be utilized to signal the presence of hard-to-detect group D
salmonella colonies on agar culture plates. A system such as the
Analytical Profile Index for Enterobacteriaceae (API) may also be
utilized to aid cultural identifications.
* * * * *
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[[Page 11524]]
Secs. 147.12, 147.14, 147.15, and 147.16 [Amended]
16. In Secs. 147.12, 147.14, 147.15, and 147.16, footnotes 11
through 21 and their references are redesignated as footnotes 12
through 22.
17. Section 147.12 is amended as follows:
a. Paragraphs (a) through (c) are redesignated as follows:
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Old section New section
------------------------------------------------------------------------
147.12(a), introductory text.............. 147.12(b)(1).
147.12(a)(1).............................. 147.12(b)(1)(i).
147.12(a)(2).............................. 147.12(b)(1)(ii).
147.12(b), introductory text.............. 147.12(b)(2).
147.12(b)(1).............................. 147.12(b)(2)(i).
147.12(c), introductory text.............. 147.12(b)(3).
147.12(c)(1).............................. 147.12(b)(3)(i).
147.12(c)(2).............................. 147.12(b)(3)(ii).
147.12(c)(2)(i)........................... 147.12(b)(3)(ii)(A).
147.12(c)(2)(ii).......................... 147.12(b)(3)(ii)(B).
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b. A new paragraph (a) and an introductory paragraph (b) are added
to read as set forth below.
c. In newly redesignated paragraph (b)(1), the introductory text of
the paragraph is amended by removing the reference ``(a)(1) or (2)''
and replacing it with the reference ``(b)(1)(i) or (b)(1)(ii)''.
d. In newly redesignated paragraph (b)(2), the introductory text of
the paragraph is amended by removing the reference ``(a)(1)'' and
replacing it with the reference ``(b)(2)(i)''.
e. In newly redesignated paragraph (b)(3)(ii), the text of newly
redesignated footnote 12 is amended by removing the words ``Animal and
Plant Health Inspection Service, Veterinary Services, National Center
for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-
1231'' and adding the words ``National Poultry Improvement Plan,
Veterinary Services, APHIS, USDA, 1500 Klondike Road, Suite A-102,
Conyer, GA 30207'' in their place.
f. A new paragraph (b)(2)(ii) is added and reserved.
Sec. 147.12 Procedures for collecting environmental samples and
cloacal swabs for bacteriological examination.
* * * * *
(a) For egg- and meat-type chickens, waterfowl, exhibition poultry,
and game birds. All samples and swabs described in this paragraph shall
be cultured in accordance with illustration 2 of Sec. 147.11, including
delayed secondary enrichment. All salmonellae recovered shall be
serogrouped or serotyped.
(1) Environmental samples. Fecal material, litter, dust, or floor
litter surface or nest box drag swab samples to be submitted for
bacteriological examination shall be collected in accordance with the
procedures described in paragraphs (a)(1), (a)(2), or (a)(3) of this
section:
(i) Procedure for sampling in broth. Authorized laboratories will
provide capped tubes 1 to 2 cm in diameter and 15 to 20 cm in length
that are two-thirds full of a recently made, refrigerated, sterile
enrichment broth (Hajna or Mueller-Kauffmann Tetrathionate Brilliant
Green) for each sample. Sufficient tubes shall be taken to the premises
to provide at least one tube per pen or one tube per 500 birds,
whichever is greater. At least one sterile, cotton-tipped applicator
will be needed for each tube. The dry applicator is first placed in or
drawn through fresh manure (under roost, near water troughs, fecal
droppings, or diarrhetic droppings). After each streaking, place the
cotton-tipped applicator in the tube of broth and swirl the applicator
to remove the collected material. Withdraw the applicator from the tube
and use it to take additional specimens by streaking on or through
areas where defecation, trampling of feces, or settling of dust is
common; e.g., on or near waterers, feeders, nests, or rafters, etc.
When the volume of material collected equals approximately 10 percent
of the volume of the broth (usually 10-12 streakings), place the
applicator in the tube and break the stick in half, leaving the lower
or cotton-tipped half in the broth and retaining the upper half for
future disposal. Replace the cap on the inoculated tube and continue
the sampling procedure in other areas of the pen.
(ii) Procedure for sampling in dry containers. Place a sample of
fecal material, litter, or dust in a sterile, sealable container. The
sample shall consist of several specimens of material taken from a
representative location in the pen or house. Collect at least 10 g
(approximately a heaping tablespoonful) of material for each sample.
Collect the specimens in each sample with a sterile tongue depressor or
similar uncontaminated instrument. The samples shall vary in type and
consistency. Half of the samples shall be comprised of material
representing defecated matter from a large portion of the flock; i.e.,
trampled, caked material near waterers and feeders. The minimum number
of samples to be taken shall be determined by the following: Five
samples from pens or houses of up to 500 birds; Ten samples from pens
or houses of 500 to 2,500 birds; Fifteen samples from pens or houses
with more than 2,500 birds. The samples may be pooled to not fewer than
five samples at the laboratory as long as the volume of material
collected equals approximately 10 percent of the volume of the broth.
(2) Cloacal swabs. Cloacal swabs for bacteriological examination
shall be taken from each bird in the flock or from a minimum of 500
birds in accordance with the procedure described in paragraph (a)(2)(i)
of this section.
(i) Procedure for taking cloacal swabs. The authorized laboratory
will provide sterile capped tubes or other suitable containers and
cotton-tipped applicators for use in taking the cloacal swabs. Insert
the cotton-tipped applicator into the cloaca and rectum in such a
manner as to ensure the collection of fecal material. Place the swab
and adhering fecal material in the tube and break the stick in half,
keeping the upper half of the stick for future disposal. The cloacal
swabs may be combined in the sterile tubes in multiples of five or in
combinations specified by the authorized laboratory.
(ii) [Reserved].
(3) Drag-swabs. Utilization of drag swabs (DS) involves the
exposure of gauze pads, a key component of a DS sampler, to the surface
of random, flock-representative floor litter and nest box areas. The
sampler pads shall be sterile and slightly moist to promote adherence
of particulate material, and impregnated with double-strength skim milk
11 to protect salmonella viability during sample collection,
batching, storage, and shipment. Floor litter surface DS sample results
tend to reflect the salmonella carrier/shedder status of a flock.
Nonetheless, other environmental samples as described in paragraphs
(a)(1)(i), (a)(1)(ii), or (a)(3)(iv) of this section shall also be
periodically collected.
\11\ Obtain procedure for preparing double strength skim milk
from USDA-APHIS ``Recommended Sample Collection Methods for
Environmental Samples,'' available from the National Poultry
Improvement Plan, Veterinary Services, APHIS, USDA, 1500 Klondike
Road, Suite A-102, Conyer, GA 30207.
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(i) Drag-swab sampler assembly. Drag-swab (DS) samplers may be
assembled using two 3- by 3-inch sterile gauze pads; size 20 wrapping
twine; and paper clips, staples, or similar fasteners. Fold each gauze
pad in half and attach one pad to a 2-foot-long (60 cm) piece of twine
and the other to a 1-foot-long (30 cm) piece of twine. To attach a pad
to the twine with a paper clip, bend the end wires of the paper clip
slightly and push them through the fabric of the folded pad, thus
securing the clips to the folded pads; then securely tie the twine to
the free rounded end of the paper clip. To attach a pad to the twine
[[Page 11525]]
with a staple, staple the twine to the pad near the center of the fold,
applying the staple at a right angle to the twine and parallel to the
fold. (A pre-tied knot in the free end of the twine will prevent the
twine from slipping under the staple during use.) Once the pads and the
twine have been attached, securely connect the free ends of both
lengths of twine to a small loop tied at the end of a 5-foot-long piece
of twine. The resulting assembly resembles the letter Y, with a long
vertical stem and two diagonal branches of different lengths with a
gauze pad securely attached to the end of each branch. Wrap the twine
around each two-pad DS sampler to produce a small bundle. Autoclave the
assembled DS sampler bundle and transfer it with sterile forceps or
other aseptic method to a resealable sterile bag. Aseptically add 15 mL
of double-strength skim milk to the bag and massage the milk into the
gauze pads. Seal the bags and store at -20 deg.C.
(ii) Procedures and applications for DS samplers. DS samplers shall
be completely thawed prior to use. Complete pad/twine/fastener
assemblies shall be used to sample floor litter surfaces; nest box
surfaces may be sampled using 3- by 3-inch sterile gauze pads
impregnated with double-strength skim milk in the manner described in
paragraph (a)(1) of this section. In either instance, the Plan
participant collecting the samples shall wear a fresh pair of
disposable sterile gloves for each flock or house sampled. Each sampler
bag shall be marked with the type of sample (floor litter or nest box
surface) and the identity of the house or flock from which the sample
was taken.
(iii) Floor litter sampling technique. For flocks with fewer than
500 breeders, at least one DS set (two DS pads) shall be dragged across
the floor litter surface for a minimum of 15 minutes. For flocks with
500 or more breeders, a minimum of two DS sets (four DS pads) shall be
dragged across the floor litter surface for a minimum of 15 minutes per
DS set. Upon completion of dragging, lower each DS pad by its attached
twine into a separate, resealable sterile bag. Alternatively, each DS
set of two pads may be lowered by its attached twine into the storage/
transport bag from which the DS set was originally taken. Remove the
twine from the pad or DS set by grasping the pad or DS set through the
sides of the bag with one hand while pulling on the twine with the
other hand until the connection is broken. Seal the bags and promptly
refrigerate them to between 2 and 4 deg. C. Do not freeze. Discard the
twine in an appropriate disposal bag.
(iv) Nest box sampling technique. The Plan participant shall
collect nest-box samples by using two 3- by 3-inch sterile gauze pads
premoistened with double-strength skim milk and wiping the pads over
assorted locations in about 10 percent of the total nesting area. Upon
completion, place each pad in a separate, resealable sterile bag. Seal
the bags and promptly refrigerate them to between 2 and 4 deg. C. Do
not freeze.
(v) Culturing of litter surface and nest box samples. When
refrigerated to between 2 and 4 deg. C, pads impregnated with double-
strength skim milk may be stored or batched for 5 to 7 days prior to
culturing. Pads shipped singly or paired in a single bag shall not be
pooled for culturing but shall be separately inoculated into 60 mL of
selective enrichment broth.
(b) For turkeys. * * *
* * * * *
18. In Sec. 147.14, paragraph (a)(2)(ii) is revised to read as set
forth below.
Sec. 147.14 Procedures to determine status and effectiveness of
sanitation monitored program.
* * * * *
(a) * * *
(2) * * *
(ii) Tetrathionate selective enrichment broths, competitor-
controlling plating media (XLT4, BGN, etc.), delayed secondary
enrichment procedures, and colony lift assays detailed in paragraph
(a)(5) and illustration 2 of Sec. 147.11.
19. A new Sec. 147.17 is added to subpart B to read as follows:
Sec. 147.17 Laboratory procedure recommended for the bacteriological
examination of cull chicks for salmonella.
The laboratory procedure described in this section is recommended
for the bacteriological examination of cull chicks from egg-type and
meat-type chicken flocks and waterfowl, exhibition poultry, and game
bird flocks for salmonella.
(a) From 25 randomly selected 1- to 5-day-old chicks that have not
been placed in a brooding house, prepare 5 organ pools, 5 yolk pools,
and 5 intestinal tissue pools as follows:
(1) Organ pool: From each of five chicks, composite and mince 1- to
2-gram samples of heart, lung, liver, and spleen tissues and the
proximal wall of the bursa of Fabricius.
(2) Yolk pool: From each of five chicks, composite and mince 1- to
2-gram samples of the unabsorbed yolk sac or, if the yolk sac is
essentially absent, the entire yolk stalk remnant.
(3) Intestinal pool: From each of five chicks, composite and mince
approximately 0.5 cm\2\ sections of the crop wall and 5-mm-long
sections of the duodenum, cecum, and ileocecal junction.
(b) Transfer each pool to tetrathionate selective enrichment broth
(Hajna or Mueller-Kauffmann) at a ratio of 1 part tissue pool to 10
parts broth.
(c) Repeat the steps in paragraphs (a) and (b) of this section for
each five-chick group until all 25 chicks have been examined, producing
a total of 15 pools (5 organ, 5 yolk, and 5 intestinal).
(d) Culture the 15 tetrathionate pools as outlined for selective
enrichment in illustration 2 of Sec. 147.11. Incubate the organ and
yolk pools for 24 hours at 37 deg.C and the intestinal pools at 41.5
deg.C. Plate as described in illustration 2 of Sec. 147.11 and examine
after both 24 and 48 hours of incubation. Confirm suspect colonies as
described. Further culture all salmonella-negative tetrathionate broths
by delayed secondary enrichment procedures described for environmental,
organ, and intestinal samples in illustration 2 of Sec. 147.11. A
colony lift assay may also be utilized as a supplement to TSI and LI
agar picks of suspect colonies.
Sec. 147.26 [Amended]
20. In Sec. 147.26, in paragraph (a), the introductory text is
amended by removing the word ``and'' and by adding the words ``, U.S.
S. Enteritidis Monitored, and U.S. S. Enteritidis Clean'' immediately
before the word ``classifications''.
21. In Sec. 147.43, the introductory text of paragraph (a) is
amended by adding two new sentences before the first sentence to read
as set forth below; by removing the words ``the Assistant Secretary of
Agriculture for Marketing and Inspection Services, or his/her
designee,''; and by removing the words ``and who shall be designated as
vice chairperson,''.
Sec. 147.43 General Conference Committee.
(a) The General Conference Committee Chairperson and the Vice
Chairperson shall be elected by the members of the General Conference
Committee. A representative of the Animal and Plant Health Inspection
Service will serve as Executive Secretary and will provide the
necessary staff support for the General Conference Committee. * * *
* * * * *
Done in Washington, DC, this 15th day of March 1996.
Lonnie J. King,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-6834 Filed 3-20-96; 8:45 am]
BILLING CODE 3410-34-P
