02-6268. 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; [phone].

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 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 § 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 §§ 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 § 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 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 § 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 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.

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 §§ 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:

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 § 93.301, paragraph (j)(7) is revised to read as follows:

§ 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)

§ 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)”.

§ 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)”.

§ 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.

Footnotes

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.