Salmonella Enteritidis Phage-Type 4; Remove Import Restrictions

From: GPO_OnLine_USDA
Date: 2002/12/16


[Federal Register: December 16, 2002 (Volume 67, Number 241)]
[Proposed Rules]
[Page 77004-77007]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de02-17]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 71, 82, and 94

[Docket No. 00-107-1]
RIN 0579-AB31

Salmonella Enteritidis Phage-Type 4; Remove Import Restrictions
and Salmonella Enteritidis serotype Enteritidis; Remove Regulations

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the regulations to remove import
restrictions on eggs (other than hatching eggs) of poultry, game birds,
and other birds from regions where Salmonella enteritidis phage-type 4
exists. Previously, Salmonella enteritidis phage-type 4 had not been
isolated in the United States; therefore, those import restrictions
were necessary to help prevent Salmonella enteritidis phage-type 4 from
being introduced into this country. However, Salmonella enteritidis
phage-type 4 is now known to be present in the United States. This
action would eliminate restrictions on the importation of eggs from
regions where Salmonella enteritidis phage-type 4 exists. We are also
proposing to remove our regulations regarding poultry disease caused by
Salmonella enteritidis serotype enteritidis.
    These regulations are no longer enforced, and it is necessary to
remove them to make our regulations consistent with our enforcement.

DATES: We will consider all comments that we receive on or before
February 14, 2003.

ADDRESSES: You may submit comments by postal mail/commercial delivery
or by e-mail. If you use postal mail/commercial delivery, please send
four copies of your comment (an original and three copies) to: Docket
No. 00-107-1, Regulatory Analysis and Development, PPD, APHIS, Station
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that your comment refers to Docket No. 00-107-1. If you use e-mail,
address your comment to regulations@aphis.usda.gov. Your comment must
be contained in the body of your message; do not send attached files.
Please include your name and address in your message and ``Docket No.
00-107-1'' on the subject line.
    You may read any comments that we receive on this docket in our
reading room. The reading room is located in

[[Page 77005]]

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 dockets, are available on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. Michael David, Assistant Director,
Sanitary International Standards Team, National Center for Import and
Export, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231;
(301) 734-3577.

SUPPLEMENTARY INFORMATION:

Background

    The regulations in 9 CFR part 94 (referred to below as the
regulations) govern the importation of specified animals and animal
products into the United States in order to prevent the introduction of
various animal diseases including Salmonella enteritidis phage-type 4.
S. enteritidis phage-type 4 is one of several kinds of Salmonella
bacteria, and it has been isolated and identified as the cause of
numerous outbreaks of salmonellosis in poultry in many parts of the
world. Additionally, it has become one of the most prevalent serotypes
causing salmonellosis in humans.
    In this document, we are proposing to remove the import
restrictions related to S. enteritidis phage-type 4 contained in part
94, as well as the interstate movement restrictions related to S.
enteritidis serotype enteritidis contained in our regulations in 9 CFR
parts 71 and 82 (S. enteritidis phage-type 4 is one of several strains
of S. enteritidis serotype enteritidis). As explained in greater detail
in the following paragraphs, the regulations in parts 71 and 82
regarding poultry disease caused by Salmonella enteritidis serotype
enteritidis are no longer enforced, and it is necessary to remove them
to make our regulations consistent with our enforcement. Further,
because those interstate movement restrictions are not enforced, it is
necessary to remove the import restrictions in part 94 in order to
eliminate, consistent with our obligations under international
agreements, import requirements that are more restrictive than our
domestic movement requirements.
    When S. enteritidis phage-type 4 was first identified as affecting
poultry, it was seen as a serious threat. S. enteritidis phage-type 4
can cause significant mortality in poultry flocks, sometimes as high as
20 percent. Once introduced, salmonellosis can spread rapidly
throughout a flock. It may also be passed from one generation to the
next by transovarial transmission and eggshell penetration.
    The regulations in Sec. 94.6 restrict, among other things, the
importation of eggs (other than hatching eggs) into the United States
that were produced by poultry, game birds, or other birds that were
raised in any region where S. enteritidis phage-type 4 is considered to
exist, imported from any region where S. enteritidis phage-type 4 is
considered to exist, or moved into or through any region where S.
enteritidis phage-type 4 is considered to exist at any time before
importation or during shipment to the United States. Canada is listed
in Sec. 94.6(b)(2) as the only region considered to be free of S.
enteritidis phage-type 4.
    At the time the import restrictions in Sec. 94.6 concerning S.
enteritidis phage-type 4 were established, S. enteritidis phage-type 4
had not been isolated in the United States, so these import
restrictions were necessary to help prevent the introduction of the
disease into this country. However, in May of 1994, S. enteritidis
phage type 4 was detected in the State of California in a commercial
layer flock. Since that initial detection, S. enteritidis phage-type 4
has been found in flocks across the United States.
    State and Federal programs are in place to monitor and control S.
enteritidis phage-type 4 in the United States. In addition to State
laws, the cooperative State/Federal/industry National Poultry
Improvement Plan includes a ``U.S. S. Enteritidis Clean'' program for
certifying the freedom of hatching eggs and chicks from S. enteritidis.
    There are regulations in subpart C of 9 CFR part 82 that contain,
in part, restrictions on the interstate movement of eggs from flocks
affected with S. enteritidis serotype enteritidis. As noted previously,
S. enteritidis phage-type 4 is one of several strains of S. enteritidis
serotype enteritidis.
    There are also regulations in 9 CFR 71.3(a) that prohibit the
interstate movement of poultry and animals affected by certain
diseases, including S. enteritidis serotype enteritidis, with certain
exceptions. Specifically, paragraph (c)(4) of Sec. 71.3 provides that
poultry affected with disease caused by S. enteritidis serotype
enteritidis may be moved interstate in accordance with 9 CFR part 82.
    However, the regulations regarding S. enteritidis in subpart C of
part 82 and Sec. 71.3 are no longer enforced and have not been
enforced since the mid-1990s. In 1995, as a result of the Department of
Agriculture Reorganization Act of 1994 (Pub. L. 103-354, October 13,
1994), the U.S. Department of Agriculture's Food Safety and Inspection
Service (FSIS) received the authority and resources to support pathogen
reduction programs relating to S. enteritidis, including the authority
to administer and enforce the regulations in subpart C of part 82 and
Sec. 71.3. This reorganization streamlined authority to allow FSIS to
control and monitor S. enteritidis as, primarily, a human health
concern. Then, in fiscal year 1996, Congress determined that the egg
industry had developed its own S. enteritidis program and deferred
funding for the enforcement of the regulations regarding S. enteritidis
in subpart C of part 82 and Sec. 71.3 and for other Federal S.
enteritidis programs.
    Because those regulations are no longer enforced, flocks in the
United States that are affected with S. enteritidis serotype
enteritidis, including phage-type 4, are not subject to the interstate
movement restrictions contained in Sec. 71.3 and subpart C of part 82.
We are, therefore, proposing to amend Sec. 71.3 by removing its
references to S. enteritidis serotype enteritidis and to amend part 82
by removing subpart C.
    Additionally, because S. enteritidis phage-type 4 is known to exist
in the United States and the movement of eggs from affected flocks is
not subject to interstate movement or other restrictions, we are
proposing to remove the import restrictions in Sec. 94.6 on the
importation of eggs (other than hatching eggs) of poultry, game birds,
and other birds from regions where S. enteritidis phage-type 4 exists
to eliminate import requirements that are more restrictive than our
domestic movement requirements. Removing those provisions would mean
that the definitions in Sec. 94.0 for the terms Salmonella
enteritidis, Salmonella enteritidis, phage-type 4, and Salmonellosis
would no longer be needed. We would, therefore, remove those
definitions from Sec. 94.0.

Miscellaneous

    We are also proposing to remove a reference in Sec. 94.6 to
Velogenic Viscerotropic Newcastle Disease (VVND). This disease is now
called Exotic Newcastle Disease (END) and is referred to as such
elsewhere in our regulations. Additionally, we are

[[Page 77006]]

proposing to correct a footnote in Sec. 94.6. This footnote refers to
``Operational Support'' staff, which is an outdated title. The new name
for that staff is ``Animal Health Programs.'' We would also make
several nonsubstantive editorial changes to the regulations for clarity
and consistency.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been reviewed under Executive Order 12866.
The rule has been determined to be significant for the purposes of
Executive Order 12866 and, therefore, has been reviewed by the Office
of Management and Budget.
    We are proposing to amend the regulations to remove import
restrictions on eggs (other than hatching eggs) of poultry, game birds,
and other birds from regions where S. enteritidis phage-type 4 exists.
Previously, S. enteritidis phage-type 4 had not been isolated in the
United States; therefore, those import restrictions were necessary to
help prevent S. enteritidis phage-type 4 from being introduced into
this country. However, S. enteritidis phage-type 4 is now known to be
present in the United States. This action would eliminate restrictions
on the importation of eggs from regions where S. enteritidis phage-type
4 exists. We are also proposing to remove our regulations regarding
poultry disease caused by S. enteritidis serotype enteritidis. These
regulations are no longer enforced, and it is necessary to remove them
to make our regulations consistent with our enforcement.
    The following analysis, which also serves as our cost-benefit
analysis, considers the potential economic effects of this proposed
rule on domestic egg producers.
    S. enteritidis phage-type 4 is considered to exist in all parts of
the world except Canada. Under the current regulations, the importation
of eggs (other than hatching eggs) from or through regions affected
with S. enteritidis phage-type 4 is restricted, but not prohibited.
However, in 1999, the last year for which relevant census information
is available, the United States imported only 5.8 million dozen eggs
(other than hatching eggs), which is equivalent to less than 0.1
percent of U.S. production that year. Eighty percent of these shell egg
imports were from China. Imported eggs from Canada, the only region not
subject to import restrictions because of its freedom from S.
enteritidis phage-type 4, accounted for less than 1 percent of all U.S.
shell egg imports in 1999.
    The United States does not export a significant amount of its egg
supply. In 1999, the United States exported 117 million dozen eggs
(other than hatching eggs), which is equivalent to only 2 percent of
the U.S. nonhatching egg production for that year. As these figures
indicate, virtually all eggs produced in the United States are consumed
domestically.
    After China, the United States is the world's second largest egg
producer. In China and other top egg-producing countries, including
Japan, India, Russia, Mexico, and France, virtually all eggs produced
are consumed domestically. Combined, these 6 countries exported 122
million dozen eggs in 1999, less than 1 percent of their combined
production that year. While the Netherlands exported the most eggs (226
million dozen), that region is not among the top 7 egg-producing
nations. Mexico reported no egg exports between 1996 and 1999.
    We expect that this proposed rule would have little or no effect on
U.S. producers, large or small, for the following reasons:
    [sbull] Current restrictions on eggs (other than hatching eggs)
from regions where END exists are quite similar to the restrictions
regarding S. enteritidis phage-type 4 that we are proposing to remove.
    [sbull] END is considered to exist in five of the top six foreign
egg-producing regions. Therefore, with the exception of France, where
END is not considered to exist, import restrictions on eggs would still
be in place for the regions most likely to export eggs to the United
States.
    [sbull] Transporting eggs to the United States from foreign markets
is expensive.
    [sbull] Egg production in the United States is highly mechanized,
which offsets potential cost advantages that foreign producers may have
over U.S. producers with regard to labor wage rates.
    Based on these considerations, we believe that the proposed removal
of the restrictions on the importation of eggs from regions where S.
enteritidis phage-type 4 exists would not result in any appreciable
increase in egg imports or otherwise affect domestic egg producers.
    Additionally, we do not expect any impact on domestic egg producers
or other poultry producers to result from our proposed removal of the
regulations regarding S. enteritidis in subpart C of part 82 and Sec.
71.3 since these regulations are no longer enforced and have not been
enforced since fiscal year 1995.
    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 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 inconsistent with this rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.

Paperwork Reduction Act

    This proposed rule contains no information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).

List of Subjects

9 CFR Part 71

    Animal diseases, Livestock, Poultry and poultry products,
Quarantine, Reporting and recordkeeping requirements, Transportation.

9 CFR Part 82

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

9 CFR Part 94

    Animal diseases, Imports, Livestock, Meat and meat products, Milk,
Poultry and poultry products, Reporting and recordkeeping requirements.

    Accordingly, we propose to amend 9 CFR parts 71, 82, and 94 as
follows:

PART 71--GENERAL PROVISIONS

    1. The authority citation for part 71 would be revised to read as
follows:

    Authority: 7 U.S.C. 8304-8306, 8308, 8310, 8313, and 8315; 7 CFR
2.22, 2.80, and 371.4.

Sec. 71.3 [Amended]

    2. Section Sec. 71.3 would be amended as follows:
    a. In paragraph (a), by removing the words ``poultry disease caused
by Salmonella enteritidis serotype enteritidis,''.
    b. By removing paragraph (c)(4) and redesignating paragraph (c)(5)
as paragraph (c)(4).

PART 82--EXOTIC NEWCASTLE DISEASE (END) AND CHLAMYDIOSIS

    3. The authority citation for part 82 would continue to read as
follows:

    Authority: 7 U.S.C. 8304-8306, 8308, 8313, and 8315; 7 CFR 2.22,
2.80, and 371.4.

[[Page 77007]]

    4. The title for part 82 would be revised to read as above.

Subpart C--[Removed]

    5. In part 82, subpart C (Sec. Sec. 82.30 through 82.38) would be
removed.

PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL
PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, HOG
CHOLERA, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND
RESTRICTED IMPORTATIONS

    6. The authority citation for part 94 would continue to read as
follows:

    Authority: 7 U.S.C. 450, 7711-7714, 7751, 7754, 8303, 8306,
8308, 8310, 8311, and 8315; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701;
42 U.S.C. 4331 and 4332; 7 CFR 2.22, 2.80, and 371.4.

Sec. 94.0 [Amended]

    7. Section 94.0 would be amended by removing the definitions of
Salmonella enteritidis, Salmonella enteritidis, phage-type 4, and
Salmonellosis.
    8. Section 94.6 would be amended as follows:
    a. By revising the section heading to read as follows.
    b. By removing paragraph (b) and redesignating paragraphs (c), (d),
and (e) as paragraphs (b), (c), and (d), respectively.
    c. In newly redesignated paragraph (b)(2), by removing the comma
after the word ``Administrator'' and, at the end of the paragraph, by
removing the word ``him'' and adding the words ``the Administrator'' in
its place.
    d. In newly redesignated paragraph (b)(6), in the first sentence,
by removing the words ``paragraph (c)'' and adding the words
``paragraphs (b)(1) through (b)(5)'' in their place and by removing the
words ``,Veterinary Services'', and, in the third sentence, by removing
the words ``paragraph (e)'' and adding the words ``paragraph (d)'' in
their place.
    e. In newly redesignated paragraph (c), by revising the paragraph
heading and the introductory text to read as follows.
    f. In newly redesignated paragraph (c)(1)(ix)(C)(1), footnote 7, by
removing the words ``Operational Support,'' and adding the words
``Animal Health Programs,'' in their place.
    g. In newly redesignated paragraph (c)(1)(ix)(C)(2), in the last
sentence, by removing the word ``VVND'' and adding the word ``END'' in
its place.
    h. By removing newly redesignated paragraph (c)(1)(x).
    i. In newly redesignated paragraph (c)(2), in the last sentence, by
removing the words ``or S. enteritidis, phage-type 4,''.
    j. In newly redesignated paragraph (c)(3), by removing the words
``or S. enteritidis, phage-type 4,'' both times they occur, and by
removing the words ``paragraph (e)'' and adding the words ``paragraph
(d)'' in their place.
    k. In newly redesignated paragraph (c)(4), by removing the words
``or S. enteritidis, phage-type 4,'' both times they occur, and by
removing the words ``paragraph (e)'' and adding the words ``paragraph
(d)'' in their place.

Sec. 94.6 Carcasses, parts or products of carcasses, and eggs (other
than hatching eggs) of poultry, game birds, or other birds;
importations from regions where Exotic Newcastle Disease is considered
to exist.

* * * * *
    (c) Eggs (other than hatching eggs) from regions where END is
considered to exist. Eggs (other than hatching eggs \6\) from poultry,
game birds, or other birds may be imported only in accordance with this
section if they: Are laid by poultry, game birds, or other birds that
are raised in any region where END is considered to exist (see
paragraph (a) of this section); are imported from any region where END
is considered to exist; or are moved into or through any region where
END is considered to exist at any time before importation or during
shipment to the United States.
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    \6\ The requirements for importing hatching eggs are contained
in part 93 of this chapter.
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    Done in Washington, DC, this 11th day of December 2002.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 02-31569 Filed 12-13-02; 8:45 am]

BILLING CODE 3410-34-P



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