[Federal Register Volume 67, Number 51 (Friday, March 15, 2002)]
[Rules and Regulations]
[Pages 11561-11565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-6268]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 93
[Docket No. 00-028-2]
Importation of Horses, Ruminants, Swine, and Dogs; Inspection and
Treatment for Screwworm
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are adopting as a final rule, with two changes, an interim
rule that amended the animal import regulations to require horses,
ruminants, and swine that are imported from regions of the world where
screwworm is considered to exist to be inspected and treated, under
certain conditions, for screwworm. In the interim rule, we also amended
the regulations to require dogs that are imported from regions of the
world where screwworm is considered to exist to be inspected, and if
necessary, treated for screwworm. The interim rule was necessary to
prevent the introduction of screwworm into the United States.
EFFECTIVE DATE: March 15, 2002.
FOR FURTHER INFORMATION CONTACT: Dr. Glen I. Garris, Senior Staff
Officer, Invasive Species Team, Animal Health Programs, VS, APHIS, 4700
River Road Unit 33, Riverdale, MD 20737-1231; (301) 734-8093.
SUPPLEMENTARY INFORMATION:
Background
Screwworm is a pest native to tropical areas of South America, the
Indian subcontinent, Southeast Asia, tropical and sub-Saharan Africa,
and the Arabian peninsula that causes extensive damage to livestock and
other warmblooded animals. The adult female screwworm typically lays
her eggs in open wounds on warmblooded host animals. Screwworm larvae
hatch in as little as 12 hours and begin to feed on the flesh of the
host animal; they are fully grown within 5 to 7 days after hatching.
The fully grown larvae then drop from the host and tunnel into the
soil, where they form protective cases to house themselves while they
pupate. Adult screwworm flies emerge from these pupal cases and are
ready to mate again within 3 to 5 days.
Screwworm was eradicated from the United States in 1966. However,
in July of 1999, and again in February and March of 2000, screwworm
larvae were found in horses that were imported into the United States
from Venezuela and Argentina.
The regulations in 9 CFR part 93 (referred to below as the
regulations) prohibit or restrict the importation of certain animals
and birds into the United States to prevent the introduction of
communicable diseases of livestock and poultry. Subparts C, D, E, and F
of the regulations govern the importation of horses, ruminants, swine,
and dogs, respectively.
In an interim rule effective and published in the Federal Register
on November 13, 2000 (65 FR 67617-67624, Docket No. 00-028-1), we
amended the regulations to require horses, ruminants, and swine that
are imported from regions of the world where screwworm is considered to
exist to be inspected and treated, under certain conditions, for
screwworm. We also amended the regulations to require dogs that are
imported from regions of the world where screwworm is considered to
exist to be inspected, and if necessary, treated for screwworm. The
interim rule was necessary to prevent the introduction of screwworm
into the United States.
We solicited comments concerning the interim rule for 60 days
ending January 12, 2001. We received five comments by that date. They
were from foreign and State governments, a trade association, and a
U.S. veterinary medical association. We have carefully considered all
of the comments we received. They are discussed below by topic.
Note: As explained below, we are amending the regulations in
this final rule to require that horses that are imported from
screwworm-affected regions must be tranquilized or sedated, rather
than anesthetized, for the final examination so that the
veterinarian performing that examination can thoroughly examine the
horses' external genitalia. We are also amending the regulations to
clarify that only male horses must be tranquilized or sedated for
the purposes of the final examination. For consistency's sake, in
the preamble of this final rule, we use the terms ``sedate or
tranquilize'' in place of ``anesthetize'' in discussing the comments
submitted by the public when it is consistent with the intent of the
issues raised.
Anesthetization Requirement
In the interim rule, we set out inspection and treatment
requirements for horses, ruminants, swine, and dogs imported from any
region of the world where screwworm is considered to exist. Among other
requirements, the interim rule established that horses that are
imported from screwworm-affected regions be quarantined for a minimum
of 7 days upon arrival in the United States at an Animal and Plant
Health Inspection Service (APHIS) animal import center. On the seventh
day of quarantine, prior to a horse's release, a veterinarian must
examine the horse for screwworm at the expense of the owner or broker.
For this final examination, the interim rule provided that the
veterinarian must anesthetize the horse so that he or she can
thoroughly examine the horse's external genitalia. If screwworms are
found during this examination, the horse must be held in quarantine and
treated until free.
Several commenters took issue with requiring that horses imported
from screwworm-affected regions be anesthetized for the final
examination. These commenters stated that anesthesia is unnecessary and
that tranquilization or sedation will be sufficient in order to perform
the final examination. Two of these commenters expressed concern over
the physical risk associated with the use of anesthetics. One commenter
recommended that if APHIS finds it necessary to examine the horses for
screwworm during quarantine, then that examination could be performed
on the final day of quarantine without anesthetization. This commenter
suggested that if the veterinarian performing the final examination
determined that further examination requiring anesthetization was
necessary, then the horse could be held and examined at a later point
in time.
We agree with these commenters that sedating or tranquilizing the
horses will
[[Page 11562]]
be sufficient so that the veterinarian performing the final examination
can thoroughly examine the horses' external genitalia. Many of the
horses imported into or entering the United States from screwworm-
affected regions are valuable purebred horses. Tranquilizing or
sedating the male horses will help to ensure the safety of the horses
and the veterinarian during the examination. Therefore, we are amending
the regulations to require that horses that are imported from
screwworm-affected regions be tranquilized or sedated, rather than
anesthetized, for the final examination so that the horses' external
genitalia can be thoroughly examined by the veterinarian.
Horses Subject to the Sedation or Tranquilization Requirement
One commenter stated that, while it has been assumed that the
tranquilization or sedation requirement applies only to male horses
because of the difficulties in examining their external genitalia, the
interim rule does not specify only male horses are subject to this
requirement. This commenter recommended that we specify that male
horses must be tranquilized or sedated for the final examination.
We appreciate this commenter's suggestion. The interim rule
required that horses be tranquilized or sedated for the final
examination so that the external genitalia of the horses can be
thoroughly examined. However, we did not state that this requirement
only pertains to male horses. For greater clarity, we are amending the
regulations in Sec. 93.301(j)(7) in this final rule to specify that
only male horses are subject to this requirement.
Different Examination Requirements for Horses Than for Ruminants
and Swine
Two commenters questioned the rationale for requiring the
tranquilization or sedation of only horses for the final examination;
both commenters noted that there is no similar requirement for
ruminants or swine. One of these commenters asked if APHIS had
determined that tranquilizing or sedating ruminants and swine is
unnecessary to thoroughly examine their external genitalia, or if APHIS
had gathered information from other countries confirming that screwworm
infestations are not found on the prepuce of ruminants and swine.
Another commenter stated that if horses are tranquilized or sedated for
the final examination so that the veterinarian can thoroughly examine
the horses' external genitalia, then the genitals of all species should
be examined because screwworm infestations do not occur exclusively on
the prepuce of horses. This commenter also stated that, because of the
final examination requirement and extended quarantine period for horses
that are imported from screwworm-affected regions, the interim rule
placed a greater regulatory burden on the horse industry than on
importers of other species mentioned in the rule.
Protocol requirements for ruminants and swine are the same as for
horses, other than for the 7-day quarantine and final examination of
the tranquilized or sedated animal. Due to the life cycle of screwworm,
a minimum quarantine period of 7 days is necessary to ensure the
detection of screwworm infestations in animals that were infested just
prior to their export to the United States. Because ruminants and swine
are already required under the regulations to be quarantined for at
least 7 days, it was not necessary to adjust the length of time those
animals must be held in quarantine. It was necessary, however, to
extend to 7 days the length of time that horses, when imported from
screwworm-affected regions, must be held in quarantine, given the life
cycle of the pest.
After hatching, screwworm larvae are fully grown within 5 to 7
days. Because horses are released from quarantine close to the time
that any screwworm infestations that may have occurred just prior to
export would mature and become visible upon inspection, it is necessary
to perform an examination on the final day of quarantine to ensure that
any infestations are detected and eliminated. Due to the difficulties
in examining the external genitalia of male horses, those animals must
be tranquilized or sedated for that examination so that the
veterinarian can thoroughly examine the external genitalia while
ensuring his or her own safety, as well as the safety of the horses.
Screwworm infestations can be detected on the prepuce of ruminants
and swine. However, except for those ruminants imported from Central
America and the West Indies, ruminants and swine are already required
under Secs. 93.411 and 93.510 of the regulations to be quarantined for
15 and 30 days, respectively. During this period, the animals are
observed for disease or infestation with animal pests. These quarantine
and inspection requirements provide ample time and opportunity to
detect and eliminate any screwworm infestations on these animals.
Therefore, a final examination for these animals is unnecessary.
Ruminants from Central America and the West Indies are subject to
different importation requirements than ruminants from all other
regions. Out of those countries and regions that constitute Central
America and the West Indies, only Panama is affected by screwworm.
Panama does not have a history of ruminant exports to the United
States; within the last 10-15 years, only one ruminant, a prized bull,
was imported from Panama into the United States. In the event that
ruminants were imported from Panama, or in the event that ruminants
were imported from any other region in Central America or the West
Indies that becomes affected by screwworm, the ruminants are required
under Sec. 93.423 to be quarantined for 7 days upon arrival in the
United States, during which time they are subject to dippings and blood
tests or other tests necessary to determine if these animals are free
from communicable diseases. We believe that these requirements are
sufficient to prevent the introduction of screwworm from ruminants
imported from those regions.
Treatment Protocols
Several commenters questioned the need to quarantine horses for 7
days before performing the final examination for screwworm infestation
and recommended alternative treatment protocols. One of these
commenters suggested that if ivermectin was administered at recommended
doses 2 weeks prior to export and again 24 hours prior to export, there
would be sufficient tissue concentration of the drug to ensure that any
larvae present are killed. Another commenter questioned whether the 7-
day quarantine could be cut to 5 days with a second administration of
ivermectin upon arrival in the United States.
Research has shown that ivermectin is effective within 3 to 5 days
after treatment against the early stages of screwworm infestation,
which are difficult to observe during visual inspection of the animals.
Screwworm larvae hatch in as little as 12 hours and are fully grown
within 5 to 7 days after hatching. Although additional doses of
ivermectin administered just prior to export or upon arrival in the
United States would reduce the risk of the horses becoming infested
with screwworm, a 7-day quarantine is necessary to allow time for any
screwworms that infested the animals just prior to export to the United
States to mature and for any infestations to become visible upon
inspection.
Cancellation of Reservations at APHIS Quarantine Facilities
One commenter expressed concern over the cancellation policy for
[[Page 11563]]
reservations at quarantine facilities maintained by APHIS. This
commenter stated that reservation fees should not be forfeited if
services provided by carriers are unavailable within the required
period because of unforseen circumstances. In particular, this
commenter was concerned that transportation services for livestock from
Argentina to the United States are unreliable due to a limited number
of regularly scheduled flights and frequent, unscheduled delays that
exceed 24 hours.
The regulations in Sec. 93.304(a)(3) set out the reservation fee
requirements for securing space at quarantine facilities for horses.
The importer or importer's agent must pay or ensure payment of a
reservation fee for each lot of horses to be quarantined in a facility
maintained by APHIS. With certain exceptions, reservation fees will be
forfeited if the importer or the importer's agent fails to present for
entry, within 24 hours following the designated time of arrival, the
horse for which the reservation was made. The reservation system is
necessary in order to ensure that there is sufficient space in the
quarantine facilities and that APHIS recovers its expenses for
providing these services. Because this system is necessary and applies
to all horses quarantined at an APHIS quarantine facility, not just
those horses imported from screwworm affected regions, and because the
interim rule did not make any changes to the reservation system, this
comment falls outside the scope of this rulemaking. Therefore, we are
not making any changes to the rule as a result of this comment.
Exemptions for the 7-Day Quarantine Requirement
One commenter requested that APHIS consider allowing registered
thoroughbred horses imported temporarily into the United States and
registered thoroughbred horses returning to the United States from
screwworm-affected regions to enter the United States without meeting
the extended 7-day quarantine requirement. This commenter argued that
the risk of screwworm being introduced into the United States would be
negligible provided that these horses are kept under intensely managed
and controlled conditions while in the screwworm-affected region.
We are not making changes in this final rule as a result of this
comment. We do not currently have an assessment of the risk associated
with the importation of horses under the conditions described by the
commenter and, therefore, cannot confirm that importing horses under
those conditions would ensure against the further introduction of
screwworm into the United States. However, we may consider amending the
regulations in future rulemaking to address the issues raised by this
commenter.
Approved 7-Day Quarantine Facilities
Two commenters expressed concern over the lack of space in, and the
limited numbers of, APHIS animal import centers approved as 7-day
quarantine facilities. One of these commenters was concerned that,
because the quarantine facility located at Hollywood Park, CA, is not
approved as a 7-day quarantine center, horses entering the United
States to race at Hollywood Park from screwworm-affected countries must
be quarantined at another facility approved as a 7-day quarantine
facility. The other commenter argued that no scientific rationale
supports limiting approved quarantine centers to APHIS-owned
facilities. This commenter requested that APHIS consider authorizing
those public or private quarantine facilities that are equipped to
undertake the required inspection and testing protocols for screwworm
as approved 7-day quarantine centers.
Authorizing public or private quarantine facilities as approved 7-
day quarantine centers is outside the scope of this rulemaking.
Therefore, we are not making any changes to the rule based on this
comment. However, because recent demand for quarantine services for
horses has exceeded the space available at existing facilities, we are
considering developing standards for allowing the establishment of
permanent, privately owned quarantine facilities.
Increases in User Fees for Quarantine Services
In a final rule published in the Federal Register on August 28,
2000 (65 FR 51997-52010, Docket No. 97-058-2), we changed our user fees
for import- and export-related services for animals, animal products,
birds, germ plasm, organisms, and vectors. That final rule increased
user fees for quarantine services, among other services, for fiscal
years 2001 through 2004. One commenter requested that APHIS review
those increases in user fees for quarantine services in light of the
increased costs associated with the additional inspection and
quarantine requirements for horses imported from screwworm-affected
countries.
The annual increases in user fees for quarantine services set out
in the August 2000 final rule mentioned above reflect standard annual
increases in expenses and are necessary for APHIS to recover the
anticipated cost of providing those services each year. Because the
user fees must be adjusted annually for APHIS to recover its expenses,
and because the interim rule did not make any changes to the user fees,
reviewing or making changes to the user fees charged for quarantine
services falls outside the scope of this rulemaking.
Emergency Action and Opportunity to Comment on Rulemaking
One commenter objected to the issuance of an interim rule ``without
sufficient time to consider the issues.'' This commenter stated that,
at the time of publication, the United States was not facing such
emergency conditions that would have warranted an interim rule.
We disagree with this comment. Screwworm was eradicated from the
United States in 1966. However, in July 1999, and again in February and
March 2000, screwworm larvae were found in horses imported into the
United States from Argentina and Venezuela. The Administrator of APHIS
determined that immediate action was necessary to prevent further
introductions of screwworm into the United States. Prior notice was
impracticable and contrary to public interest under these
circumstances. The preembarkation requirements for ruminants, swine,
and dogs and preembarkation and postarrival requirements for horses
imported from any region of the world where screwworm is considered to
exist were considered necessary on an emergency basis to safeguard the
United States from screwworm.
Economic Effects
One commenter stated that the economic information presented in the
interim rule underestimated the number of horses exported from the
United Arab Emirates to the United States between 1995 and 1998. In the
interim rule, we stated that, out of those screwworm-affected regions
where other diseases that would require at least a 7-day quarantine are
not known to exist, only Argentina is a significant source of horses
imported into the United States. To support this point, we stated that
China, the Philippines, Taiwan, and the United Arab Emirates also
exported horses to the United States during the period 1995-1998, but
collectively they exported only 5 horses in 1995, 9 horses in 1996, 14
horses in 1997, and 13 horses in 1998. The commenter stated that the
number of horses exported from the United Arab Emirates alone in each
of those years exceeded the collective
[[Page 11564]]
number of horses exported from China, the Phillippines, Taiwan, and the
United Arab Emirates cited in the interim rule.
This commenter is indeed correct; while the interim rule's economic
analysis accurately estimated the number of horses imported permanently
into the United States from those regions, it did not account for
horses imported under temporary permits, such as competition or race
horses. Out of all breeding, commercial, competition, purebred, and
race horses imported, both permanently and temporarily, from screwworm-
affected regions, Argentina accounted for 83 percent (1,730 of 2,094)
of horses imported between 1996 and 2001. The United Arab Emirates
supplied 14 percent (299 of 2,094) of horses imported from affected
regions during the same 6-year period. The remaining 3 percent of
horses imported from screwworm-affected regions were from China, India,
Malaysia, Philippines, Qatar, Singapore, Taiwan, and Thailand. However,
because only 2 percent (1,952 of 94,729) of all horses imported into
the United States between 1996 and 2001 were from screwworm-affected
regions, we continue to expect that the interim rule will not have a
significant economic effect on a substantial number of small entities.
Several commenters expressed concern that the economic effects of
the interim rule on the horse industry were underestimated in the
interim rule's economic analysis. Several commenters stated that the
costs associated with the additional inspection and quarantine
requirements for horses imported from screwworm-affected regions will
have a significant impact on the U.S. horse industry, especially in
light of the increase in quarantine fees at APHIS quarantine
facilities. Several commenters also opposed the additional inspection
and quarantine requirements because the resulting cost increases, along
with reservation deposits, time away from training for horses,
additional post-quarantine time to allow for drug residues to be
eliminated prior to competition, and any potential complications, will
inhibit the movement of foreign horses to and from the United States.
For example, one commenter stated that these costs alone exceed the
value of a green polo pony from Argentina.
The additional inspection requirement for horses contained in the
interim rule affects only those importers moving horses into the United
States from regions of the world where screwworm is considered to
exist. In addition, the quarantine period is extended to 7 days only
for those horses that are imported from screwworm-affected regions
where other diseases that require at least a 7-day quarantine are not
known to exist. These requirements affect a limited number of regions.
As mentioned above, Argentina and the United Arab Emirates accounted
for 83 percent and 14 percent, respectively, of horses imported from
regions subject to these requirements during the period 1996-2001. The
remaining 3 percent of horse imports from affected regions were from
China, India, Malaysia, Philippines, Qatar, Singapore, Taiwan, and
Thailand during that same 6-year period. Furthermore, the additional
costs borne by importers moving horses into the United States from
screwworm-affected regions as a result of the additional inspection and
treatment requirements are small when compared to the import value of
the horses. For example, the average value of purebred horses imported
from screwworm-affected countries in the Western Hemisphere, excluding
Argentina, between 1998 and 2000 was $10,697. The costs for the
preembarkation inspection of and treatment for screwworm represent 1 to
2 percent of this average value.
For horses imported from screwworm-affected regions that are not
already affected by other diseases that require at least a 7-day
quarantine, the additional cost will have a larger impact. Between 1998
and 2000, the average value of purebred horses imported from Argentina
was $6,625; the preembarkation inspection and treatment costs for
screwworm, as well as the 4 additional days in quarantine, are about 13
to 14.6 percent of the average value of these horses.\1\ However, a
relatively small percentage of horses imported into the United States
are expected to be affected. Out of 94,729 horses imported into the
United States between 1996 and 2001, only 2 percent (1,952 of 94,729)
were from screwworm-affected regions.
---------------------------------------------------------------------------
\1\ The cost estimates quoted in the interim rule for horse
imports have been updated here to incorporate up-to-date import
figures for 1999 through 2001 and reflect the annual cost increases
in user fees for quarantine services provided by APHIS.
---------------------------------------------------------------------------
As only a small percentage of horses are imported into the United
States from screwworm-affected regions, it can be concluded that the
additional requirements set out in the interim rule will not
significantly impact the entire U.S. horse industry nor inhibit the
movement of foreign horses to and from the United States. The largest
impact will be borne by the importers of horses from Argentina and
other countries that must quarantine their animals for 4 additional
days. Nonetheless, we continue to expect that the interim rule will not
have a significant economic effect on a substantial number of small
entities.
In addition to the changes mentioned above, we are adding, to
Secs. 93.301, 93.405, 93.505, and 93.600, the Office of Management and
Budget control numbers assigned to the information collection
requirements associated with the interim rule, as required by the
Paperwork Reduction Act.
Therefore, for the reasons given in the interim rule and in this
document, we are adopting the interim rule as a final rule, with the
changes discussed in this document.
This final rule also affirms the information contained in the
interim rule concerning Executive Order 12866 and the Regulatory
Flexibility Act, Executive Orders 12372 and 12988, and the Paperwork
Reduction Act.
Effective Date
Pursuant to the administrative procedure provisions in 5 U.S.C.
553, we find good cause for making this rule effective less than 30
days after publication in the Federal Register. The interim rule
adopted as final by this rule was effective on November 13, 2000. This
rule provides that horses that are imported from regions of the world
where screwworm is considered to exist must be sedated or tranquilized,
rather than anesthetized, for the purposes of the examination on the
seventh day of quarantine. In addition, this rule specifies that only
male horses must be sedated or tranquilized during that examination.
Immediate action is necessary to provide for the use of an appropriate
level of chemical restraint and clarify that female horses do not
require such restraint. These changes are, therefore, necessary to
relieve requirements that we no longer find warranted. Therefore, the
Administrator of the Animal and Plant Health Inspection Service has
determined that this rule should be effective upon publication in the
Federal Register.
List of Subjects in 9 CFR Part 93
Animal diseases, Imports, Livestock, Poultry and poultry products,
Quarantine, Reporting and recordkeeping requirements.
Accordingly, the interim rule amending 9 CFR part 93 that was
published at 65 FR 67617-67624 on November 13, 2000, is adopted as a
final rule with the following changes:
[[Page 11565]]
PART 93--IMPORTATION OF CERTAIN ANIMALS, BIRDS, AND POULTRY, AND
CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR MEANS
OF CONVEYANCE AND SHIPPING CONTAINERS
1. The authority citation for part 93 continues to read as follows:
Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; 21 U.S.C. 102-105,
111, 114a, 134a, 134b, 134c, 134d, 134f, 136, and 136a; 31 U.S.C.
9701; 7 CFR 2.22, 2.80, and 371.4.
2. In Sec. 93.301, paragraph (j)(7) is revised to read as follows:
Sec. 93.301 General prohibitions; exceptions.
* * * * *
(j) * * *
(7) Horses must be held at the animal import center for a minimum
of 7 days. On day 7, prior to the horses' release, the horses must be
examined by a veterinarian at the expense of the owner or broker. For
this examination, male horses must be tranquilized or sedated so that
the external genitalia of the horses can be thoroughly examined. If
screwworm is found during this examination, the horses must be held in
quarantine and treated until free of infestation. (Approved by the
Office of Management and Budget under control numbers 0579-0040 and
0579-0165)
Sec. 93.405 [Amended]
3. Section 93.405 is amended by revising the OMB control number
citation at the end of the section to read as follows: ``(Approved by
the Office of Management and Budget under control numbers 0579-0040 and
0579-0165)''.
Sec. 93.505 [Amended]
4. Section 93.505 is amended by adding, at the end of the section,
the following: ``(Approved by the Office of Management and Budget under
control number 0579-0165)''.
Sec. 93.600 [Amended]
5. Section 93.600 is amended by adding, at the end of the section,
the following: ``(Approved by the Office of Management and Budget under
control number 0579-0165)''.
Done in Washington, DC, this 11th day of March 2002.
W. Ron DeHaven,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 02-6268 Filed 3-14-02; 8:45 am]
BILLING CODE 3410-34-P