16978 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

DEPARTMENT OF AGRICULTURE state this in the first line of your e-mail variations in the risk of disease message. Comments submitted by e-mail transmission both between regions and Plant Health Inspection will be posted to the APHIS where a disease exists and between Service Regionalization Proposal Web Page those where the disease is not present. within a few days after receipt. This We believe that these policies 9 CFR Parts 92, 93, 94, 95, 96, and 98 Web page also contains copies of the unnecessarily prohibit or restrict the [Docket No. 94±106±1] proposed rule in several formats and importation of and animal related information. The Web page URL products in many situations where such RIN 0579±AA71 is http://www.aphis.usda.gov/PPD/ importation can be carried out with Importation of Animals and Animal region. Both paper and e-mail comments insignificant risk of introducing disease Products received may be inspected at USDA, agents into the United States. room 1141, South Building, 14th Street Therefore, in this document, we are AGENCY: Animal and Plant Health and Independence Avenue SW., proposing to revise the regulations in Inspection Service, USDA. Washington, DC, between 8 a.m. and six different parts of 9 CFR to establish ACTION: Proposed rule. 4:30 p.m., Monday through Friday, importation criteria for certain animals except holidays. Persons wishing to and animal products based on the level SUMMARY: We are proposing to amend inspect comments are requested to call of disease risk in specified geographical the regulations concerning importation ahead on (202) 690–2817 to facilitate regions. We believe that these regulatory of animals and animal products. The entry into the comment reading room. changes are consistent with and meet proposed changes include a complete FOR FURTHER INFORMATION CONTACT: Dr. the requirements of international trade rewrite of 9 CFR part 92, subparts D Gary Colgrove, Chief Staff Veterinarian, agreements that have recently been (ruminants) and E (swine), a transfer of National Center for Import and Export, entered into by the United States, as current part 92 to 9 CFR part 93, and the VS, APHIS, 4700 River Road Unit 38, discussed below under the heading establishment of a new part 92. We are Riverdale, MD 20737–1231, (301) 734– ‘‘International Trade Agreements.’’ proposing to establish criteria for 8590. foreign ‘‘regions’’ based on risk class Limits of This Proposed Rule levels. The criteria would be used to SUPPLEMENTARY INFORMATION: It is important to note that the establish importation requirements for Background changes we are proposing at this time particular animals and animal products apply only to the importation of The Animal and Plant Health from different regions outside of the ruminants and swine, and their Inspection Service (APHIS), United United States. We believe this change is products. The importation of all other States Department of Agriculture in accordance with international trade types of animals would continue to be (USDA), has promulgated regulations agreements entered into by the United governed by the current regulations, regarding the importation of animals States. We are also proposing to allow, rather than by a regionalized, risk class and animal products in order to guard under certain conditions, the unloading approach. It is our intent, however, to against the introduction into the United and reloading at the port of arrival of extend, in future rulemaking, the States of animal diseases not currently meat and other animal products regionalized, risk class approach to the present or prevalent in this country. otherwise prohibited entry into the importation of all animals and animal These regulations are set forth in the United States. We believe this change is products that are subject to the Code of Federal Regulations (CFR), title warranted because it would remove regulations. 9, chapter 1. unnecessary restrictions on the Under the current regulations, with International Trade Agreements importation of meat and other animal several exceptions, restrictions on the products into the United States. Both the North American Free Trade importation of animals and animal Agreement (NAFTA) and the General DATES: Consideration will be given only products are based on whether a Agreement on Tariffs and Trade (GATT) to comments received on or before July particular disease exists in any part of Uruguay Round agreements contain 17, 1996. the foreign country from which the provisions establishing the rights and ADDRESSES: Comments may be animals or animal products originate or obligations of signatory countries submitted as paper copies or by transit before importation into the concerning sanitary and phytosanitary electronic mail. If you submit paper United States. (In a few cases, (SPS) regulation. SPS measures are copies, please send an original and three restrictions are placed on the generally defined as governmental copies of your comments to Docket No. importation of animal products from measures intended to protect human, 94–106–1, Regulatory Analysis and countries where a certain disease is not animal, or plant life or health. The Development, PPD, APHIS, suite 3C03, known to exist, because of risk factors applicable provisions are, respectively: 4700 River Road Unit 118, Riverdale, such as those countries’ importation Articles 709 through 724 of the NAFTA MD 20737–1238. Please state that your policies or proximity to countries where (‘‘NAFTA–SPS’’); and the World Trade comments refer to Docket No. 94–106– the disease exists.) Organization (WTO) Agreement on the 1. We encourage the submission of The current USDA policy of Application of Sanitary and copies by electronic mail, since this prohibiting or restricting importations Phytosanitary Measures (‘‘WTO–SPS’’). both facilitates our analysis of the based solely on whether a disease exists Although the two agreements differ in comments and allows us to make the anywhere within a national entity does a few respects, both NAFTA–SPS and text of comments available to the public not take into account whether regions WTO–SPS provide that: via the Internet. The e-mail address for within a country, or regions made up of comments on this proposed rule is 94– several countries, have in place A Member Country shall recognize the concepts of regions of low pest or disease 106–[email protected]. Please be sure to adequate natural and man-made prevalence, and shall ensure that its sanitary include your full name and organization defenses against the introduction or and phytosanitary measures are adapted to in any comments you submit by e-mail. spread of animal diseases in those take into account the characteristics of If your e-mail comment is a duplicate of regions. Nor, we believe, do the current regions from which products originate and to a paper copy you have submitted, please regulations adequately address which products are destined. In doing so, the Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 16979

Member should take into account relevant to U.S. livestock if no import ban many animals and products affected geography, ecology, methods of surveillance restrictions were in place. New part 92 with other diseases. and effectiveness of control systems. would also include a list of restricted However, we believe that several [NAFTA–SPS, Article 716; WTO–SPS, factors now make it necessary to Articles 6.1–6.2] diseases for the purposes of the import regulations. Each of these provisions is provide specific regulatory restrictions The changes being proposed in this discussed in detail below. for certain diseases not currently regulation are intended to comply with Additionally, new § 92.4 would addressed in the regulations. The first U.S. obligations under NAFTA–SPS and include a listing of the risk classification factor is this proposed revision of the WTO–SPS with respect to the APHIS has assigned to each region of import regulations, which would importation of live animals and animal the world for each restricted disease provide for regionalization and for products. agent. The listing in this proposed rule various classification levels of disease Format Changes to 9 CFR consists, for the most part, of countries, risk. Under this proposal, for example, because, under the existing regulations, and unlike under the current Because we are proposing to make disease status is determined on a regulations, the fact that FMD exists in significant substantive changes to the country-by-country basis. However, this one region of a country may not current regulations in order to proposed rule would allow for significantly restrict the importation of incorporate provisions regarding both application for regional status for areas animals and animal products from regionalization and the risk smaller or larger than individual another region of the same country, if classification of exporting regions, we countries. The application process is the two regions are so separated and believe it is necessary, to aid readers of discussed in this Supplementary monitored that the risk of the disease the regulations, to make several major Information under the heading being transferred from one region to the formatting changes to 9 CFR. Although ‘‘Application for Risk Class other is negligible. This is a departure we are proposing to amend in some way Recognition.’’ from the current regulations, in which parts 92, 93, 94, 95, 96, and 98, only two FMD in any part of country determines of those parts—parts 92 and 93—would Proposed Part 92 the FMD status of the entire country. require extensive structural The second factor is the progress As noted above, we are proposing to reformatting. We would make a number many countries have made in set forth in part 92 the criteria for of substantive changes to part 94, but eradicating, or moving toward classification of regions according to that part would largely retain its current eradication of, rinderpest and FMD in risk assessment as required by NAFTA format. Parts 95, 96, and 98 would specific regions. In countries where and GATT. These criteria would be require fewer substantive changes and FMD exists, an increasing number of incorporated into the amended no format changes. regions have eradicated or come close to regulations in parts 93, 94, 95, 96 and eradicating the disease. Therefore, Parts 92 and 93 98, which contain restrictions on the under this proposal, import restrictions importation of certain animals and The regulations in current parts 92 due to FMD in one part of a country and 93 govern the importation into the animal products. could no longer be relied upon to guard United States of certain live animals, in As revised, § 92.2 would list those against the importation of diseases not order to prevent animals infected with disease agents and vectors of agents that specifically addressed in the certain diseases from transmitting those would be restricted entry into the regulations. diseases to livestock and poultry in the United States, either because they are In addition to FMD and rinderpest United States. The animals regulated by not known to exist in the United States viruses, other disease agents that are current part 92 include birds, poultry, or because they are subject to Federal or specifically addressed in current parts horses, ruminants, swine, dogs, cooperative Federal/State control or 92 and 94 are: In part 94, African swine hedgehogs and possums. Current part 93 eradication programs in the United fever virus, hog cholera (also known as regulates the importation of elephants, States. Some of the diseases that we are classical swine fever virus), swine hippopotami, rhinoceroses, and tapirs. proposing to list in revised § 92.2 are vesicular disease virus, velogenic As part of the format changes we are already addressed in the current import Newcastle disease virus (also known as proposing, we would move the regulations. In addition, we are avian pneumoencephalitis or VVND regulations in current part 92 to part 93. proposing to add other specified virus), fowl pest (also known as fowl Along with this relocation of the current diseases. plague or highly pathogenic avian part 92 regulations, we would make The diseases we would add to those influenza), bovine spongiform extensive changes to two of the subparts already addressed in the regulations encephalopathy, and Salmonella in current part 92—subpart D have, in many cases, been of concern enteritidis phage type 4; in part 92, (ruminants) and subpart E (swine). even under the current regulations, but Akabane virus, bluetongue virus, These changes are discussed in detail have not posed a significant practical epizootic hemorrhagic disease virus, below in this supplementary risk because the countries in which they contagious pleuropneumonia, surra information. exist have also been countries in which caused by Trypanosoma evansi, fever The movement of current part 92 to rinderpest or foot-and-mouth disease and other ticks, vesicular part 93 would leave no regulations at (FMD) exists. The current regulations stomatitis, Trypanosoma vivax, dourine part 92. We are proposing to fill the ban the importation into the United caused by Trypanosoma equigenitalium, vacated part 92 with an entirely new set States of most animals and animal glanders caused by Pseudomonas of regulations, which would include products from countries in which mallei, equine piroplasmosis caused by criteria for establishing geographical rinderpest or foot-and-mouth disease Babesia equi or B. caballi, equine regions for the purpose of importing exists. In those cases where animals and infectious anemia, contagious equine animals and animal products, and animal products are allowed to be metritis caused by Taylorella criteria for classifying regions according imported from these countries, they equigenitalis, African horse sickness to the disease risk (risk assessment and must meet stringent quarantine or virus, Venezuelan equine encephalitis classification) that animals and animal processing requirements. These virus, epizootic lymphangitis caused by products from those regions would pose prohibitions and safeguards effectively Histoplasma farciminosum, and Taenia 16980 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules multiceps (also known as Taenia 55(7):349–350). It could be a potentially primary reservoir. This is potentially a coenurus). serious problem in the southern States costly disease for the milk industry of the United States because of the in the United States. (Mare´, J., 1992, Additions of Exotic Diseases distribution of potential vectors. If it Foreign Animal Diseases, U. S. Animal In this document, we are proposing to were to become established, there Health Assoc., Richmond, VA, 140– add the following exotic diseases to the would be little likelihood that it could 145.) list of restricted diseases mentioned be eradicated. (St. George, T. D., 1992, Globidiosis is due to the protozoan above. A description of the disease that Foreign Animal Diseases, U. S. Animal parasites Besnoitia besnoiti that affect would be added is included with each Health Assoc., Richmond, VA, 125– ruminants, causing damage to skin, entry. 133.) subcutis, blood vessels, mucous African or wildebeest or alcephalene Bovine infectious petechial fever, also membranes and other tissues. They malignant catarrhal fever (MCF) is known as Ondiri disease, is caused by cause large, thick-walled cysts and caused by a herpesvirus found in Africa, the rickettsia Erlichia (Cytocetes) ondiri severe debilitation of the animal. and is primarily transmitted from carrier in and results in high mortality, Convalescence is slow, and permanent wildebeest to cattle when the wildebeest abortion, and reduced lactation. It is sterility can occur in male animals. calve. Wildebeest are the primary found primarily in east Africa, and a Affected animals are lifelong carriers, reservoir of this virus. The ‘‘- vector is suspected. Infected cattle but cats and other felines are the associated form’’ of MCF is present in can remain infected for many months. definitive carrier host. It is found in most of the world, including the United There may be potential ticks or other southern Europe, Africa, Asia, and States. Neither the wildebeest- vectors in the United States that can South America, and is transmitted by transmitted form nor the sheep- transmit the rickettsial cause of this several biting flies, many species of associated form of MCF are known to disease. (Davies, G. 1993. Vet. which exist in the United States. A spread directly from cattle to cattle, so Microbiol. 34(2):103–121.) related species, Besnoitia bennetti is the principal concern would be Brucella melitensis has been rare, but has been found in the southern importation of wildebeest or other host eradicated from the United States, but is States of the United States, and can species from Africa that could increase found in Mexico, Central and South cause a chronic disease in horses. This the spread and seriousness of the America, southern Europe, Asia, and species would not be considered a disease in cattle or native wildlife Africa. It is a serious disease, causing restricted agent. (Levine, N.D., 1985, species, some of which have been abortion in sheep and , and can Veterinary Protozology, Iowa St. U. shown to be susceptible. (Heuschele, W. also infect cattle. It is also a serious Press, Ames, IA, 256–259.) P., 1992, Foreign Animal Diseases, U. S. human health risk. (Alton, G.G., 1990, Goat pox and sheep pox viruses cause Animal Health Assoc., Richmond, VA, in Animal Brucellosis., Ed. Neilson, K. acute to chronic generalized pox 273–284.) Because it cannot be and J. R. Duncan, CRC Press, Boca lesions, fever, and pneumonia with a concluded with certainty that other Raton, FL, 383–410.) long recovery and occasionally high ruminants cannot spread the disease, Congo or Crimean hemorrhagic mortality in sheep and goats. They are the restrictions of this proposal with disease virus is caused by tick- found in Africa, Asia, and parts of regard to MCF would apply to all transmitted virus and causes fever, Europe. Besides loss of animal ruminants. anorexia and depression in cattle and productivity, these viruses cause Aino virus is a Bunyavirus of the goats in Africa and Asia. It may cause damage to hides and wool. The viruses Simbu group that produces fatal a sporadic, severe, and often fatal are very resistant and can be carried on deformities in cattle similarly to disease in people. A tick-rodent-cattle hides or wool. (House, J. A, 1992, Akabane virus. It has been found in cycle maintains the virus in nature. Foreign Animal Diseases, U. S. Animal and Asia, particularly in Japan Birds are responsible for distributing Health Assoc., Richmond, VA, 343– and Taiwan. It is transmitted by various infected ticks, but most birds are 350.) species of Culicoides and, because of resistant. Infection has been reported in Heartwater, also known as the distribution of potential vectors in ratites. Transmission to humans has Cowdriosis, is caused by a rickettsia the southern United States, could been reported to occur with direct Cowdria ruminantium and produces an potentially become endemic in that area contact with blood of infected cattle and acute disease of ruminants transmitted if it were to become established. ostriches. This group of viruses is not by ticks. It is primarily transmitted by (Moriwaki, M. et al. 1977. Natl. Inst. found in the Western hemisphere but ticks of the genus Amblyomma. It is one Anim. Heal. Qtrly, Jap. 17(3):95–106.; could possibly become established, and of the three most serious livestock St. George, T. D. et al. 1989, in The would be virtually impossible to diseases in Africa, and has been found Arboviruses: Epidemiology and Ecology. eradicate. (Lvov, D.K., 1994, in on some of the islands of the Caribbean. Vol IV. Ed. Monath, T.P. CRC Press, Handbook of Zoonoses, 2nd Ed. Section Two native North American species of Boca Raton, FL, 145–166.; Fukutomi, T. B., ed. Beran, G. W., CRC Press, Boca Amblyomma have been found capable 1991. J. Jap. Vet. Med. Assoc. 44(1):17– Raton, FL, 251–252.) of transmitting the disease. Some wild 19.) Contagious agalactia of sheep and ruminant species in Africa are known to Bovine ephemeral fever, also known goats caused by Mycoplasma agalactiae be carriers of the infection. This is as Kotonkan, Obadhiang, Puchong, or results in fever, malaise, arthritis, eye potentially one of the most serious bovine epizootic fever virus, is an lesions, and, in females, mastitis and exotic disease threats to the U. S. -borne viral disease of cattle reduced milk production. Losses are livestock industry. (Mare, J., 1992, and water buffalo in Africa, Australia due to high morbidity and loss of milk Foreign Animal Diseases, U. S. Animal and Asia. Affected cattle suffer severe and meat production. It is found in parts Health Assoc., Richmond, VA, 218– loss of weight and condition, decreased of Europe, Asia, and North Africa and 228.) milk production, and infertility in has been reported from Australia, South Japanese encephalitis virus causes males. The reservoir hosts are not Africa, and South America. Low encephalitis in people and horses. Its known, but water buffalo have been virulence strains are found in North primary reservoir is in birds and in shown to have a prolonged viremia America, but do not cause classical swine, in which it causes stillbirths. It (Young, P.L., 1979, Austl Vet J. disease. Infected animals are the is transmitted by various species of Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 16981 mosquitoes. It is primarily found in Near east encephalomyelitis affects causes abortions and a fatal illness in temperate and tropical eastern Asia. horses and domestic ruminants, causing young animals, and is transmitted by (Shope, R. E., 1992. Foreign Animal a low-grade fever, nervous signs and various species of mosquitoes, including Diseases, U. S. Animal Health Assoc., death. The causative agent is uncertain, native North American species. Its Richmond, VA, 246–253.) but a tick-borne virus is suspected. The distribution has been limited to Africa. Jembrana disease, also known as disease is similar to Borna disease, Animals do not remain carriers of the Tabanan disease, is caused by a which is found in Europe. The disease virus for long periods of time. (Peters, C. retrovirus related to Bovine is found in the Middle East and Asia. J. and K. J. Linthicum, 1994, in Immunodeficiency-like Virus (Robertson, 1976, Handbook on Animal Handbook of Zoonoses, 2nd Ed., Section (Chadwick, B. J., 1995, J. Gen. Virol. Diseases in the Tropics, British Vet. B., Ed. Beran, G. W., CRC Press, Boca 76(1):189–192). It causes a rinderpest- Assoc., London, Eng, UK. 67–68.) Raton, FL, 125–138.) like disease of cattle and buffalo, and Nairobi sheep disease virus, also Teschen disease, also known as has caused heavy losses in . known as Dugbe or Ganjam virus, is polioencephalomalacia of swine, Talfan Recovered cattle may be lifetime transmitted by ticks to sheep and goats disease, or benign enzootic paresis, is an carriers. Ticks are thought to be a vector. and is characterized by acute infectious nervous disease of pigs (Hartaningih, N., et al., 1993. Vet. hemorrhagic gastroenteritis and high caused by an enterovirus similar to Microbiol. 38(1–2):15–23; ibid. 38(1– mortality. The disease is found in Africa human poliomyelitis. It has been found 2):23–29; Darma, D.M.N, et al., 1994. and Asia (Ganjam virus). The primary only in Europe and parts of Africa. Vet. Immunol. & Immunopath. 44(1):31– reservoir is the tick Rhipicephalus Control programs in Europe have 44.) This virus could be a serious appendiculatus, in which transovarial virtually eliminated the virulent form of disease problem in much of the world. transmission of the virus occurs. Other the virus in Europe. Similar Until the epidemiology is better known, ticks have been found able to transmit enteroviruses of swine with low great care should be taken to avoid the virus, but cannot maintain the virus pathogenicity are found throughout the importing animals that may carry this because they do not transmit it through world, including North America. virus into the United States. their eggs. (Groocock, C. M., 1992, Infected swine may shed the virus for Lumpy skin disease virus, also known Foreign Animal Diseases, U. S. Animal several weeks even though they may be as Neethling virus, causes an acute or Health Assoc., Richmond, VA, 285– asymptomatic. (Derbyshire, J. B., 1989, chronic disease in cattle characterized 292.) in Virus Infections of Porcines, Ed. M. by skin nodules and lymphadenitis. The Parafilaria bovicola is a filarial worm B. Pensaert, Elsevier Science Publishers, virus is similar to sheep pox and goat that causes hemorrhagic nodules on the B.V., New York, NY, 225–239.) pox viruses. It is found throughout skin, with bruise-like lesions under the Theileriosis, also known as east coast Africa and the Middle East. It is skin and in muscle tissues. Several fever, corridor disease, or Mediterranean transmitted primarily by biting flies. licking flies have been shown to be fever, are a group of diseases that affect Losses are primarily due to a prolonged capable of transmitting the parasite, cattle and that occur primarily in Africa recovery, with emaciation, lowered milk including some present in the United and the Mediterranean area. The production, hide damage, and other States. Although the parasite has been causative agent of east coast fever, secondary infections. The virus may found in imported cattle in Canada, it Theileria parva, and the causative agent persist for long periods on contaminated does not appear to have become of corridor disease, T. lawrenci, are premises. The disease is very difficult to established. All regions of the world limited in their distribution to Africa by eradicate once it becomes established. except Australia, New Zealand, North the distribution of Rhipicephalus spp. (House, J. A., 1992, Foreign Animal America, and South America appear to ticks, which are the intermediate host. Diseases, U. S. Animal Health Assoc., be affected with this parasite. Losses However, the existence of potential Richmond, VA, 264–272.) include damage to hides, and vectors in the United States could make Melioidosis, caused by the condemnation of meat from slaughtered introduction of this agent an animal saprophytic soil bacteria Pseudomonas animals. (Steen Bech-Nielsen, 1992, health problem in this country. pseudomallei, affects people and a wide Foreign Animal Diseases, U. S. Animal Mediterranean fever is caused by T. variety of animals and resembles Health Assoc., Richmond, VA, 293– annulata, which is found in the glanders. It occurs widely throughout 302.) Mediterranean area and eastern Europe southeastern Asia and parts of the Peste des petits ruminants, also and for which the intermediate host are tropical Americas, including Puerto known as goat plague, is a contagious ticks of the Hyalomma genus. Malignant Rico. It is a serious public health disease due to a virus similar to theileriosis of sheep and goats is caused problem in southeastern Asia and also rinderpest virus in sheep and goats. by T. hirci, and the intermediate host causes serious loss of production in Rare cases have been described in cattle has been shown to be ticks of the genus animals. Animals may be latently and swine, but these animals appear Rhipicephalus and Hyalomma. It is infected for many months. Once the soil unable to transmit the disease to other similar to T. annulata in its distribution. becomes contaminated, it is virtually animals. It occurs in Africa, the Middle (Young, A. S. and C. M. Groocock, 1992, impossible to eliminate the organism. East and southern Asia. Wild ungulates Foreign Animal Diseases, U.S. Anim. The soil of the southeastern States in the such as the white-tailed deer in the Heal. Assoc., Richmond, VA, 177–187; United States could readily become United States are susceptible. The virus 1976, Handbook on Animal Diseases in endemically contaminated with the could become established in sheep or the Tropics, Ed. Robertson, A., British organism. Care must be taken to be goats in the United States and cause Vet. Assoc., London, Eng., 178–189.) certain that imported animals are not severe losses if it became established in Tick-borne encephalitis, also known the source of introduced contamination white-tailed deer herds or other native as louping ill or Central European with the organism, as they would more North American wild ruminants. (Saliki, encephalitis, is caused by a tick- likely result in soil contamination than J. T., 1992, Foreign Animal Diseases, transmitted group of viruses found in infected humans. (Grove, M. G., U.S. Anim. Health Assoc., Richmond, Asia and Europe. Louping ill primarily Harrington, K. S., 1994, Handbook of VA, 303–310.) affects sheep with an acute, often fatal, Zoonoses, Section A. 2nd Ed., CRC Rift Valley fever virus affects encephalitis. Swine, cattle, horses, and Press, Boca Raton, FL, 155–165.) ruminants, dogs, cats and people. It humans may also be affected. There may 16982 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules be ticks in the United States that could identifiable by geological, political, or disease in question, no importations of transmit these agents, but they have not surveyed boundaries.’’ Under this susceptible animals or animal products been sufficiently researched. (Timoney, definition, a region may be a national would be allowed from regions P. J., 1992, Foreign Animal Diseases, entity, part of a national entity, classified as Risk Class R3, R4, or RU. U.S. Animal Health Assoc. Richmond, combined parts of several national Under this proposal, it is possible that VA, 254–263.) entities, or a group of several national a region would have two or more Tick-borne fever (TBF), due to the entities combined into a single trading different classifications for different rickettsia Erlichia (Cytocetes) block. Section 92.5 of this proposed rule diseases that affect the same type of phagocytophilia, affects domestic and contains procedures, discussed below animal. For example, with regard to wild ruminants, causing high fever, under the heading ‘‘Application for Risk diseases that affect swine, a region reduced lactation and abortion. It is Class Recognition,’’ for requesting could theoretically be classified as RN transmitted by various ticks. It is found establishment of a specific region. for African swine fever and R3 for hog in Africa, Asia and Europe. The carrier cholera. In such a case, the risk state in cattle lasts for several months. Criteria for Risk Classification classification with the more stringent The disease is seldom fatal but causes As discussed above, this proposed restrictions (in this case R3 for hog a severe immunosuppression that rule is a departure from the current cholera) would govern the importation exacerbates other latent infections, such regulations in that a region would not be of any swine from the region, in order as Johne’s disease. (Larsen, H. J. S. et al., classified simply as one in which a to assure that the most protective 1994, Res. Vet. Sci. 56(2):216–224.) It specific disease is or is not known to restrictions are applied. may be able to be transmitted by some exist. Rather, a region in which we have Criteria for Risk Classification native North American ticks, so care determined that a certain disease does should be taken to prevent introduction. not exist would be classified as one of A region could seek a particular risk (Robertson, A., 1976, Handbook on three different risk class levels, classification in one of two ways. The Animal Diseases in the Tropics, Brit. depending on the risk that the disease first option would be to demonstrate to Vet. Assoc. London, Eng. U.K. 88–90.) might be introduced into the region. APHIS that it meets a series of Wesselsbron virus causes abortions, Likewise, under this approach, two conditions, discussed below under the neonatal death and congenital separate risk classifications for regions heading ‘‘Risk Class Criteria,’’ regarding abnormalities primarily in sheep, but in which a disease is known to exist such factors as disease history, also has caused mild disease in cattle, would be established, as well as one surveillance, geography, and goats, pigs, equines, camels, rodents, additional risk class category for infrastructure. Assessing disease risk dogs, and humans in sub-Saharan countries or regions that do not yet have based solely on such conditions is Africa. It is carried by many species of specific classification as another risk consistent with APHIS’s current method African wildlife and is transmitted by class level. Therefore, under this of determining the risk that a particular mosquitoes. This disease, if introduced proposed rule, regions would fall into disease exists in a country. It differs into the United States, could probably one of six risk class levels or categories. from our current approach in that it become established. It is likely that The six risk class levels would be would be applicable to regions, rather mosquito vectors in the United States titled ‘‘RN’’ or ‘‘negligible risk class than just to countries, and that it takes could easily transmit the virus. regions,’’ ‘‘R1’’ or ‘‘slight risk class into account different levels of risk. (Barnard, B.J.H., 1990, in Virus region,’’ ‘‘R2’’ or ‘‘low risk class region,’’ We recognize, however, that Infections of Ruminants, Ed. Dinter, Z. ‘‘R3’’ or ‘‘moderate risk class region,’’ qualitative conditions can be used in and B. Morein, Elsevier Sci. Publishers, ‘‘R4’’ or ‘‘high risk class region,’’ and developing a quantitative risk New York, NY, 291–294.) ‘‘RU’’ or ‘‘unknown or unclassified risk assessment (QRA) that estimates the class region.’’ The criteria for each risk probability of the existence of disease in Additions of Domestic Diseases class are set forth in § 92.3 of this numerical terms. We view such a QRA, In addition to import restrictions to proposal. A region classified as RN conducted according to accepted guard against the importation into the would present the least risk of disease scientific standards, as an alternative to United States of animal diseases from transmission, with R1, R2, R3, and R4 assessing disease risk based solely on other countries, the regulations in 9 CFR presenting increasing risk of disease qualitative criteria, and have included contain requirements regarding transmission. An RU region would be such an option in § 92.3 of this livestock disease agents that exist in the one that has not yet been classified. proposed rule. Therefore, under this United States but that are subject to It is important to note that each of the proposed rule, a region seeking a Federal or cooperative Federal/State risk classifications would be based on particular disease classification could control or eradication programs. For unrestricted importation of animals and do so either by meeting the qualitative ruminants and swine, these diseases animal products—i.e., the risk of a criteria for that classification, or by include Brucella abortus, B. suis (9 CFR disease being imported into the United conducting and submitting to APHIS a part 78), Mycobacterium bovis (9 CFR States if no mitigating biosecurity scientifically valid QRA determined by part 77), pseudorabies virus (9 CFR part measures were in place. Under this the Administrator to demonstrate that 85), scabies (9 CFR part 73), and scrapie proposal, the actual biosecurity the probability of the existence in that (9 CFR parts 54 and 79). With our measures for the importation of animals region of a live animal infected with a proposed shift to a regionalized and animal products become particular disease does not exceed the approach, we believe it is now increasingly stringent as the risk class risk limit we propose for that disease necessary to specifically address these number increases. With these classification. The risk limit for each of diseases in the import regulations. biosecurity measures in place, we the risk level classifications is discussed believe that the disease risk from the below. Definition of Region importation of animals and animal Because determination of disease risk In §§ 92.1, 93.401, 93,501, 94.1, 95.1, products from each of the regions would through a scientifically valid QRA and 96.1 of this proposed rule, we be negligible, or equivalent to that of a would constitute a substantial departure would define the term region to mean Risk Class RN. In some cases, however, from our current method of assessing ‘‘any defined geographic land region because of the virulent nature of the the disease risk of an area, we encourage Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 16983 comments from the public on whether beneficial but not necessarily required commitment on the part of the animal such QRA’s constitute a reasonable in all cases. The requirement for surveys health authorities governing the region alternative to assessing risk solely based could depend upon the disease and type and of the animal industry in question on qualitative criteria, and, if so, what of infrastructure in the region. For to respond to any occurrences of a methodologies would be acceptable in instance, although it may be necessary, restricted agent. We would interpret determining disease risk. We are in order to determine the initial ‘‘respond’’ to mean taking action to proposing that a risk classification classification of a region, to have a rapidly control and eradicate any would be assigned by the Administrator survey conducted to establish that a occurrences of the restricted agent that based on a QRA only after the disease does not appear to be present, might occur. Administrator has reviewed the there may be no need for subsequent If a QRA using scientifically accepted assessment and has determined that it surveys as long as passive surveillance methods is done, the results for an RN was developed according to exists. This determination would be region would need to show that fewer scientifically acceptable methods. made by the APHIS evaluation team that than 1 out of 1 million (1 x 10¥6) live For each of the proposed risk evaluates the application for recognition animals would be expected to be classifications we discuss below, we set of a region. Not requiring active affected with the restricted agent. Based forth a risk limit we believe would be surveillance in all cases in an RN region on the standards of negligible risk acceptable for that classification if a would be parallel to the situation in the employed by other Federal agencies, we valid QRA were conducted. For United States, where as a rule routine believe that a region in which 10¥6 live instance, for a region to be classified as surveillance testing is not done for animals would be expected to be Risk Class RN (Negligible Risk), we exotic diseases but passive surveillance infected could reasonably be classified propose that a QRA must conclude that is maintained. as a region of negligible risk. fewer than 1 per 1 million (10¥6) live Additionally, for a region to be A region previously classified as Risk animals in that region would be classified as RN, the restricted agent Class RN in which a restricted agent is expected to be infected with a restricted could not be known to exist within any determined to exist could be reclassified agent. We have proposed these defined region adjacent to the RN as Risk Class RN 3 years after all known numerical limits based on the level of region, and any adjacent R1 or R2 infected and exposed reservoirs of risk we believe should reasonably be regions (described below) for the disease disease in the region have been expected in a region considered to be of would need to be separated from the RN eliminated. ‘‘negligible,’’ ‘‘slight,’’ ‘‘low,’’ region by natural or man-made physical Risk Class R1 Regions ‘‘moderate,’’ ‘‘high,’’ or ‘‘unknown’’ risk, barriers or protected borders. All border respectively. We recognize, however, access points from adjacent R1 or R2 Animals or animal products imported that research and other data may be regions for the disease would need to be without restriction from a region available from the public that will controlled to prevent movement of classified as Risk Class R1 would suggest that the numerical limits we are susceptible animals or animal products present a slight risk of introducing or proposing be adjusted before this rule is from the adjacent regions, except under spreading a disease in the United States. made final. We encourage the conditions that have been reviewed and Again, the dictionary definition of the submission of such information from approved by the Administrator of term would apply. ‘‘Slight’’ is defined as the public. APHIS. Movement of animals and ‘‘small of its kind or in amount’’ A discussion of each of the risk class animal products into the RN region from (Webster’s 3rd New International levels follows. R1, R2, R3, R4 or RU regions for the Dictionary, 1966, Rand McNally and Co. Chicago, Ill.). We would consider a Risk Class RN Regions disease would need to be done only under conditions that have been region that presents a slight risk (Risk Animals or animal products imported determined by the Administrator to Class R1) to be essentially the same as from a region classified as Risk Class RN achieve the same level of biosecurity as one that presents a negligible risk (Risk would present a negligible risk of required for importation from R1, R2, Class RN), except that regions classified introducing or spreading a disease in R3, R4, or RU regions into the United as R1 that have been previously affected the United States. The dictionary States. with a particular disease may not have definition of ‘‘negligible’’ would Also, in general, vaccination of any been without the presence of the disease apply,i.e., ‘‘so small or unimportant or potential carrier animals for restricted for as long a period of time as an RN of so little consequence as to warrant disease agents must have been region, and R1 regions may be regions little or no attention’’ (Webster’s 3rd prohibited within the RN region during that share borders with, or trade New International Dictionary, 1966, the lifetime of any currently living extensively with, regions where the Rand McNally and Co. Chicago, Ill.). susceptible animals. However, disease is known to exist. The To achieve Risk Class RN vaccinations could be allowed for likelihood of residual infection in the classification, the region would have to certain diseases such as vector- R1 region would be considered to be be one in which the restricted agent has transmitted diseases, or for animals negligible. not been diagnosed within the region specifically vaccinated to meet import Vaccination requirements would be during the lifetime of any currently requirements of other regions, when the the same as for Risk Class RN regions, living susceptible animals. The mere Administrator determines that such except that there could be animals fact that the restricted agent has not vaccination would not increase the risk within the region that were vaccinated been reported in a region would not be of importing restricted agents into the prior to the region being classified as considered adequate evidence of United States. Whether such Risk Class R1, provided they are under absence of the disease, if it cannot be vaccination would be allowed would provisional quarantine. In § 92.1 of the shown that surveillance in the region is depend on the disease in question, the proposed regulations, a provisional in place to report, diagnose, and control type of vaccine used, and factors such quarantine would be defined as any occurrences of the disease (passive as whether the vaccinated animals are restrictions placed on movements of surveillance). Occasional or periodic immediately exported from the region. vaccinated livestock where the surveys for the restricted agent in the In a region classified as Risk Class RN, restricted agent in question is not region (active surveillance) would be there would need to be resources and known to exist in livestock, but where 16984 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules the possibility of exposure exists. Under agent in the past, but in which a Risk Class R3 Regions a provisional quarantine, vaccinated sufficient period of time has passed (5 Animals or animal products imported livestock not known to be affected with years for bovine spongiform without restriction from a Risk Class R3 the disease could be moved to affected encephalopathy and scrapie, 1 year for region would present a moderate risk of regions, i.e., to regions having animals all other restricted diseases) with no introducing or spreading a disease in affected with the disease, or to regions reported cases of the disease to make it the United States. Such a region would that do permit vaccination. likely that active disease no longer meet the definition of a ‘‘low prevalence Under the proposed regulations, a exists in the region. In a Risk Class R2 region’’ under the GATT agreement. region classified as R1 could be adjacent region, the maximum annual herd (GATT, Side Agreement on the to regions that are affected with the incidence of the restricted agent over Application of Sanitary and disease in question, but would need to the past 5 years would need to be less be separated from those regions by Phytosanitary Measures, Annex A, Item than 0.1 percent, the likelihood of 7; also GATT Implementing Act, Dec. natural or man-made physical barriers, residual infection would be low and or by protected borders. If border 1994, Sanitary and Phytosanitary there would be a low risk of importation Measures, Section 1, Paragraph f). In an controls were not in place, affected of affected animals, animal products or animals, animal products, or vectors R3 region, a restricted agent may have vectors from adjacent areas or trading been diagnosed within the previous could move or be moved readily across partners. the border. However, to guard against year, but the annual herd incidence of Any adjacent R3, R4, or RU regions the disease over the previous 5 years such movement, all border access points for the disease would need to be from adjacent R2, R3, R4 or RU regions may not have exceeded 0.1 percent. separated by natural or man-made Any adjacent R4 and RU regions for would need to be controlled to prevent physical barriers, or protected borders, movement of susceptible animals or the disease would need to be separated and there would need to be suitable by natural or man-made physical animal products from the adjacent control of border access points from regions, except under conditions that barriers or protected borders, and all adjacent R3, R4, or RU regions for the border access points from adjacent R3, have been reviewed and approved by disease to prevent movement of the Administrator. R4, or RU regions for the disease would susceptible animals or animal products have to be strictly controlled to prevent In an R1 region, there must be active from the adjacent regions, except under surveillance for the restricted agent in movement of susceptible animals or conditions that have been reviewed and the region. However, as a matter of animal products from the adjacent approved by the Administrator. policy, we would not require that the regions, except under conditions that Movement of animals and animal surveillance be continuous, because, in have been reviewed and approved by products into the R2 region from R3, R4, a region classified as Risk Class R1, the the Administrator. Movement of or RU regions for the disease could be concern would not be primarily with animals and animal products into the done only under conditions that have residual infection in the region or with region would need to be carried out been reviewed by the Administrator and vaccine masking of infection. Any only under conditions that have been that have been determined to achieve infection that might be found in the reviewed by the Administrator and that the same level of biosecurity as required region should be an introduced have been determined to achieve the for importation from R3, R4, or RU infection. Because the population in an same level of biosecurity as required for regions into the United States. R1 region would be susceptible and the importation from R4 or RU regions into There would need to be a continuous disease would be one not familiar to the the United States. active surveillance program in the region, passive surveillance would be Vaccination would be allowed under region, as well as a passive surveillance effective in detecting any occurrence of the same conditions as for an R2 region. system, and, as for an R1 region, there the disease. The requirement regarding Such a region would need to have an would need to be resources and adequate response to disease active control and surveillance program, commitment on the part of the animal introduction that is discussed above with the goal of eradicating the disease health authorities governing the region under RN criteria would also apply to in question. and of the animal industry in question R1 regions. The results of a QRA for an R3 region, If a QRA is done using scientifically to respond to (i.e., rapidly control and if done, would need to show that fewer accepted methods, the results for an R1 eradicate) any occurrences of the than 1 per 1,000 (1x10¥3) live animals region would need to show that fewer restricted agent. would be expected to be infected with than 1 per 100,000 (1x10¥5) live Vaccination may be allowed in the R2 the restricted agent. region, under the same conditions as for animals would be expected to be Risk Class R4 Regions infected with the restricted agent. an RN or R1 region, with additional A region previously classified as Risk vaccination allowed for those herds that Animals or animal products imported Class RN or R1 in which a restricted are at greatest risk of exposure from without restriction from a Risk Class R4 agent is determined to exist could be animals from affected regions. region would present a high risk of reclassified as Risk Class R1 2 years Generally, however, as a matter of introducing or spreading a disease in after all known infected and exposed policy, vaccinated animals will not be the United States. A ‘‘high risk’’ region reservoirs of disease in the region have allowed into the United States. Under would be one in which a control and been eliminated. our current regulations in parts 92 and surveillance program exists, but in 94, a country that permits vaccination which the prevalence of the restricted Risk Class R2 Regions would not normally be considered free agent is excessively high or where the Animals or animal products imported of the disease in question. program does not have the goal of without restriction from a Risk Class R2 If a QRA is done using scientifically eradication. In an R4 region, a restricted region would present a low risk of accepted methods, the results for an R2 agent has been diagnosed during the introducing or spreading a disease in region would need to show that fewer previous year, and the annual herd the United States. A Risk Class R2 than 1 per 10,000 (1x10¥4) live animals incidence of the disease over the past 5 region would be one that has been would be expected to be infected with years may have exceeded 0.1 percent in affected with a particular restricted the restricted agent. 1 or more years or may be unknown. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 16985

The R4 region would need to maintain or country factor (explained below) in in the destination risk. We are using this a passive and active surveillance system calculating the final risk. cautious approach to determine risk for restricted disease agents, but the based on the premise that any Calculating Risk level of surveillance may not fully meet importation of a restricted agent is standards for an R3 region. In determining whether a particular undesirable. In an R4 region, vaccination for any commodity (animal or animal product) However, we invite comments on restricted agent may vary from herd to should be imported into the United whether ‘‘destination risk’’ should also herd within the region. If vaccination is States, the ultimate concern is how be factored into ‘‘final risk.’’ We used as the primary control procedure, much of a risk of disease introduction recognize that, in some cases, the at least 80 percent of the livestock in 80 does that commodity present. For the restricted transportation in the United percent of the herds must be vaccinated purposes of this discussion, we refer to States and ultimate restricted use of a as often as recommended by the the ultimate risk of disease introduction regulated product can reduce the risk manufacturers of the vaccine. In an R4 as ‘‘final risk.’’ Before a commodity that the product will endanger the region, movement of animals and would be allowed to be imported under livestock of the United States. For animal products from R3, R4 and RU this proposed rule, the final risk would instance, § 94.12(b)(4) of the current regions for the restricted agent may not have to be negligible. regulations allows, in specific cases, for In arriving at final risk, several be adequately controlled. the importation of small amounts of different types of risk need to be The results of a QRA for an R4 region, pork or pork products whose considered. These risks can be importation is otherwise restricted due if done, would need to show that less identified according to the source than 1 per 100 (1x10¥2) live animals to the existence of swine vesicular (country or region), to the commodity disease in the country of origin, would be expected to be infected with (live animals or animal products), and the restricted agent. provided the pork or product is to the destination (importing country or imported for examination, testing, or Risk Class RU Regions region). All of these risks contribute to analysis, and provided the importation calculating the final risk of disease An additional risk category, Risk is approved by the Administrator. introduction into the importing country We invite comment on whether Class RU, will be defined as an or region. Even commodities from factors such as destination or use should unclassified or unknown risk. Such a regions with a relatively high source be generally considered in establishing region may not have any surveillance or risk can present a negligible final risk if ‘‘final risk’’ under the revised control program. A region classified as adequate mitigating measures are taken regulations. We particularly invite RU may report no known occurrence of to reduce the commodity risk. Measures comment regarding the mitigating a restricted agent, but, because of lack can also be taken at the destination (e.g., effects of the use of products and the of surveillance, cannot be expected to post-entry quarantine) to reduce the destination of animals. For example, provide reliable data about the destination risk. with regard to a vector-borne disease, occurrence of the disease in the region. The risk classifications described in should restrictions on the importation of A region classified as RU may have the § 92.3 of this proposed rule establish the an animal take into account whether the necessary data to qualify as a classified risk only for the source, with no vector is not known to exist in the area region, but if the officials in the region consideration of what kind of product or of the animal’s destination, or is not have not furnished the data, requested commodity is being exported. These risk active at the time of year the animal is classification of the region, or allowed classifications are then used as a starting to be imported? reasonable access as required in point from which to determine the NAFTA, vol. I, part 2, chap. 7, section necessary mitigating measures for each Proposed Risk Model B, article 716 or GATT-AASPM, article commodity, as set forth in §§ 93.415 and The formulae for calculating the risk 6, the region shall remain unclassified. 93.515 of this proposed rule, for live of importing a restricted agent can be The results of a QRA may not be ruminants and swine respectively, and illustrated with the following model: possible from an RU region due to lack as set forth in parts 94, 95, 96, and 98 Assuming that a commodity with a risk of information; or, if information is for meat, germplasm, and other animal factor calculated to be 1 per million (1/ available, the results may exceed 1 per products. 1,000,000) is imported from a source ¥ 100 (1x10 2) live animals in the region The ‘‘commodity risk’’ is distinct from region classified as R3 (risk factor 1 per expected to be infected. the source or destination risk. In thousand (1/1,000)) where a specific In cases where a QRA is not done, the calculating the commodity risk, the QRA has not been done, then the final qualitative criteria for classification of assumption is that the commodity risk per unit of the commodity would be an area, as set forth in proposed § 92.3, begins as infected or contaminated. The 1/1,000,000 times 1/1,000 or 1/ ‘‘Criteria for risk classification,’’ will be commodity risk would be the likelihood 1,000,000,000 (1 per billion or used to classify a region as a Risk Class that the commodity would still be .000,000,001). If 1 million animal units RN (Negligible Risk), R1 (Slight Risk), infected after the storage, handling, were going to be represented in the total R2 (Low Risk), R3 (Moderate Risk), or processing, etc., it must undergo in commodity imported per year, then the R4 (High Risk). Any region that does not reaching the final user. The commodity likelihood of importing one or more meet the qualitative requirements of risk would be the same for like infected units of the commodity would these risk classifications, or does not commodities, regardless of the source or be as follows: meet the minimally acceptable risk level destination risk. Theoretically, the final Given: expected of a QRA, will be classified as risk, i.e., the risk after mitigating P{I=0} = Probability of zero infected Risk Class RU (Unclassified or measures are applied, would be the units in the shipment. Unknown). When the results of a QRA source risk times the commodity risk P{I>0} = Probability of one or more are not available for calculating the risk times the destination risk. However, in infected units in the shipment. of introduction of a restricted agent calculating the ‘‘final risk’’ for p = Risk probability factor = 1 per through a specific commodity, then the importations into the United States, we billion or .000,000,001. upper limits of the QRA for the risk would multiply only the commodity N = Number of animal units represented class region will be used as the source risk times the source risk, and not factor in the shipment. 16986 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

Then: From the Binomial distribution RN, R1, R2, R3 or R4, we have proposed Europe: Albania, Andorra, Austria, function, the following formula is to classify the country as Risk Class RU Belgium, Bosnia-Herzogovania, derived. for unknown risk or unclassified risk. Bulgaria, Bylorus, Croatia, Czech P{I=0} = (1-p)N Where a disease agent has not been Republic, Denmark, Estonia, Finland, Therefore: reported from a country, and there is no France, Germany, Gibraltar, Greece, P{I>0} = 1–P{I=0} = 1-(1-p)N evidence that the disease agent now Greenland, Hungary, Iceland, Ireland, = 1-[1-(.000,000,001)]1,000,000 = .001 (1 exists or has ever existed in the country, Italy, Latvia, Liechtenstein, Lithuania, per 1,000) we have proposed to classify the Luxembourg, Macedonia, Moldavia, or, to calculate the frequency that such country as Risk Class RN. (Because this Monaco, Netherlands, Norway, Poland, an event would be expected to occur: rationale for Risk Class RN classification Portugal, Romania, San Marino, 1÷.001 = 1,000 is the same for most but not all Slovakia, Slovenia, Spain, Sweden, countries, we have used a footnote to Switzerland, Ukraine, United Kingdom Therefore, we could expect refer to this rationale where applicable.) (England, Scotland, Wales, Northern importation of 1 or more infected units The proposed classifications are based Ireland, Channel Islands, Isle of Man), of the commodity every 1,000 years, on the epidemiological, geographical, Vatican City, Yugoslavia. provided the same commodity from 1 and infrastructure data currently Middle America: Belize, Costa Rica, El million animal units were imported available to us. We welcome Salvador, Guatemala, Honduras, each year into perpetuity. APHIS requests comments on information from the public, supported Nicaragua, Panama. whether, or to what extent, the binomial by specific scientific evidence or other Middle East: Bahrain, Cyprus, Iraq, model proposed above is appropriate for data, concurring with or recommending Israel, Jordan, Kuwait, Lebanon, Malta, estimating in the context of animal changes to the classifications. North Yemen, Oman, Palestine, Qatar, populations. Comments should suggest In many cases, the risk classification Saudi Arabia, South Yemen, Syria, and describe alternative statistical for a particular disease is the same for Turkey, United Arab Emirates. models. all the countries in a geographically or New Zealand: New Zealand. politically linked group of countries. North America: Canada, Mexico, Listing of Risk Classifications for Therefore, to avoid unnecessary United States. Individual Regions repetition of individual countries, for Oceania: Brunei, Fiji, French Section 92.4 of this proposed rule the purposes of these regulations we Polynesia, Indonesia, Kiribati, Maldives, contains listings of risk classifications have combined countries of the world Mauritius, Nauru, New Caledonia, for individual regions. This information into groupings. The following groupings Papua New Guinea, Philippines, is presented in two formats. Proposed are set forth in § 92.1, ‘‘Definitions,’’ of Seychelles, Solomon Islands, Tonga, § 92.4(a) is formatted so that each region the proposed regulations. Vanuatu, Western Samoa. listed is followed immediately by the Africa: Algeria, Angola, Benin, South America: Argentina, Bolivia, risk classification assigned to that region Botswana, Burkina Faso, Burundi, Brazil, Chile, Colombia, Ecuador, for each restricted agent. For instance, a Cameroon, Central African Republic, French Guiana, Guyana, Paraguay, Peru, listing for all the regions in Africa is Chad, Comoros, Congo, Djibouti, Egypt, Suriname, Uruguay, Venezuela. followed by the information that those Equatorial Guinea, Gabon, Ghana, Note: We use the term ‘‘Middle regions are classified as Risk Class RN Guinea, Guinea-Bissau, Ivory Coast, America’’ for the area sometimes for Japanese encephalitis virus. Kenya, Lesotho, Liberia, Libya, referred to as ‘‘Central America,’’ in Proposed § 92.4(b) is formatted in Madagascar, Malawi, Mali, Mauritania, order to make clear that Panama is a such a way that all regions that fall Morocco, Mozambique, Namibia, Niger, part of the grouping in question. under a particular risk classification for Nigeria, Rwanda, Sao Tome and Princip, Historically, in some usages, Panama a particular disease are listed together. Senegal, Sierra Leone, Somalia, South was not considered to be part of Central For instance, the listing for RN regions Africa, Sudan, Swaziland, Tanzania, America. for Japanese encephalitis virus would The Gambia, Togo, Tunisia, Uganda, Risk Classification by Region include all regions in Africa and all Western Sahara, Zaire, Zambia, other regions that are classified RN for Zimbabwe. African swine fever virus. Japanese encephalitis virus. Asia: Afghanistan, Armenia, Risk Class RN. All regions of Asia, In the following paragraphs, we list Azerbaijan, Bangladesh, Bhutan, Burma, Atlantic, Australia, Middle America, the proposed classifications of the Cambodia, China, Georgia, Hong Kong, Middle East, New Zealand, North 1 regions of the world, and set forth the , Iran, Japan, Kazakhstan, America, and Oceania. rationale for such classifications. Kygyzstan, Laos, Macau, Malaysia, Risk Class R1. All regions of Europe Because this initial proposed listing is Mongolia, , North Korea, , except Italy, Spain and Portugal; all based on disease statuses as set forth in Russia, Singapore, South Korea, Sri regions of the Caribbean except Cuba the current regulations or, in cases Lanka, Taiwan, Tajikistak, Thailand, and Haiti; and all regions of South where the disease is not specifically Turkistan, Uzbekistan, Vietnam. America except Brazil. listed in the current regulations, on the Atlantic: Bermuda, Cape Verde, African swine fever has been reported published epidemiologic information Falkland Islands, South Georgia. in parts of Italy, Spain and Portugal. The about the disease distribution, it Australia: Australia. rest of Europe is tentatively classified as consists of national entities (countries). Caribbean: Anguilla, Aruba, R1 because the regions there are However, under this proposed rule, Barbados, British Virgin Islands, adjacent to affected regions or conduct requests may be submitted to APHIS for Cayman Islands, Cuba, Dominica, extensive trade with these regions. recognition and classification of regions Dominican Republic, Grenada, African swine fever has been reported in smaller or larger than individual Guadeloupe, Haiti, Jamaica, Martinique, Cuba, Haiti, and Brazil, and the current countries. In all cases where neither Montserrat, Netherlands Antilles, Puerto 1 The restricted agent in question has not been regulatory precedent nor adequate Rico, Saint Lucia, Saint Vincent, The reported from these countries, nor is there any published epidemiologic data existed to Bahamas, Trinidad and Tobago, Turks evidence that it now or has ever existed in these classify a country as either Risk Class and Caicos, U.S. Virgin Islands. countries. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 16987 status of the disease in these countries Middle East, New Zealand, North Finland, French Polynesia, Hungary, is uncertain. America, and South America.1 Israel, Norway, Papua New Guinea, Risk Class R2. None. Risk Class R1. None. Romania, Sweden, and Switzerland. Risk Class R3. None. Risk Class R2. None. All of these regions have reported Risk Class R4. None. Risk Class R3. None. eradication of Brucella abortus from Risk Class RU. All regions of the Risk Class R4. None. their livestock populations over 15 years world except those specifically listed as Risk Class RU. All regions of the ago. (Crawford RP, Huber JD, Adams BS. Risk Class RN, R1, R2, R3 or R4. world except those specifically listed as Epidemiology and Surveillance. in Aino virus. Risk Class RN, R1, R2, R3 or R4. Animal Brucellosis edited by Nielsen K, Risk Class RN. All regions of Atlantic, Bovine spongiform encephalopathy. and Duncan JR. CRC Press, Boca Raton, Risk Class RN. All regions of Africa, Caribbean, Europe, Middle America, Florida, 33431, 131–151, 1990.) New Zealand, North America, and Asia, Atlantic, Australia, Caribbean, Risk Class R1. Australia, Canada, South America.1 Middle America, New Zealand, Czech Republic, Germany, Slovakia, Risk Class R1. None. Oceania, and South America; all regions United Kingdom except Channel 1 Risk Class R2. None. of North America except Canada. Islands. Risk Class R3. None. Risk Class R1. All regions of the All of these regions have reported Risk Class R4. None. Middle East except Oman; All regions of eradication of Brucella abortus from Risk Class RU. All regions of the Europe except Denmark, France, Great their livestock population more than 5 world except those specifically listed as Britain, Northern Ireland, Republic of years ago. (Crawford RP, Huber JD, Risk Class RN, R1, R2, R3 or R4. Ireland, and Switzerland. Adams BS. Epidemiology and Akabane virus. Bovine spongiform encephalopathy Surveillance. in Animal Brucellosis Risk Class RN. All regions of Atlantic, has never been reported from the edited by Nielsen K, and Duncan JR. Caribbean, Europe, Middle America, Middle East except for Oman. No CRC Press, Boca Raton, Florida, 33431, New Zealand, North America, and country of Europe except those listed as 131–151, 1990.) South America.1 exceptions to Risk Class R1 have ever Risk Class R2. None. Risk Class R1. None. reported the disease. They are listed as Risk Class R3. None. Risk Class R2. None. Risk Class R1 because of adjacency to Risk Class R4. None. Risk Class R3. None. affected countries and/or extensive Risk Class RU. All regions of the Risk Class R4. None. trade with those countries. world except those specifically listed as Risk Class RU. All regions of the Risk Class R2. Canada. Risk Class RN, R1, R2, R3 or R4. world except those specifically listed as Canada had a single case of bovine Brucella melitensis. Risk Class RN, R1, R2, R3 or R4. spongiform encephalopathy in a bovine Risk Class RN. All regions of Oceania, Bluetongue virus (except serotypes 10, imported from the United Kingdom. The Australia, Canada, Czech Republic, 11, 13 and 17). animal was destroyed and the United Denmark, Estonia, Finland, Greenland, Risk Class RN. Canada, New Zealand, States has been kept well informed of Iceland, Ireland, Latvia, Lithuania, Mexico, and all regions of Europe the status of all contact animals. Luxembourg, Netherlands, New except Greece. There is no evidence of further cases Zealand, Norway, Poland, Slovakia, Bluetongue virus has not been in Canada. Sweden, United Kingdom, and Taiwan. reported in Europe, except recently in Risk Class R3. None. None of these regions has ever Risk Class R4. Denmark, France, Greece. Bluetongue type 10 occurred in reported Brucella melitensis (Alton GG. United Kingdom, Republic of Ireland, Spain and Portugal in the 1950’s but Brucella melitensis. in Animal Oman, and Switzerland. never became established. New Zealand Brucellosis edited by Nielsen K, and These are all countries that have Duncan JR. CRC Press, Boca Raton, has never had Bluetongue of any type. reported one or more cases of bovine Canada and Mexico are known only to Florida, 33431, 393–409, 1990.) spongiform encephalopathy. All of these Risk Class R1. None. be affected with the same types as the countries have programs to control the United States (10, 11, 13 and 17). Risk Class R2. None. disease. Some of these countries or Risk Class R3. None. Risk Class R1. None. regions within them may qualify as Risk Risk Class R4. None. Risk Class R2. None. Class R1, R2 or R3 regions but we do not Risk Class RU. All regions of the Risk Class R3. None. have sufficient information at present to world except those specifically listed as Risk Class R4. None. consider them for a higher class. Risk Class RN, R1, R2, R3 or R4. Risk Class RU. All regions of the Risk Class RU. All regions of the Brucellosis due to Brucella suis except world except those specifically listed as world except those specifically listed as biovar 4. Risk Class RN, R1, R2, R3 or R4. Risk Class RN, R1, R2, R3 or R4. Risk Class RN. Canada, Ireland, Besnoitia besnoiti (globidiosis). Bovine infectious petechial fever. United Kingdom. Risk Class RN. All regions of Atlantic, Risk Class RN. All regions of Asia, None of these regions has ever Australia, Caribbean, Middle America, Atlantic, Australia, Caribbean, Europe, reported Brucella suis (Alton GG. New Zealand, North America, and Middle America, Middle East, New Brucella suis. in Animal Brucellosis 1 Oceania. Zealand, North America, Oceania, and edited by Nielsen K, and Duncan JR. Risk Class R1. None. South America.1 CRC Press, Boca Raton, Florida, 33431, Risk Class R2. None. Risk Class R1. None. 411–422, 1990.) Risk Class R3. None. Risk Class R2. None. Risk Class R1. None. Risk Class R4. None. Risk Class R3. None. Risk Class R2. None. Risk Class RU. All regions of the Risk Class R4. None. Risk Class R3. None. world except those specifically listed as Risk Class RU. All regions of the Risk Class R4. None. Risk Class RN, R1, R2, R3 or R4. world except those specifically listed as Risk Class RU. All regions of the Bovine ephemeral fever virus group Risk Class RN, R1, R2, R3 or R4. world except those specifically listed as (Kotonkan, Obodhiang). Brucella abortus. Risk Class RN, R1, R2, R3 or R4. Risk Class RN. All regions of Atlantic, Risk Class RN. Belize, Bulgaria, Brucellosis due to Brucella suis biovar Caribbean, Europe, Middle America, Channel Island (U.K), Cyprus, Denmark, 4. 16988 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

Risk Class RN. Africa, Asia except Risk Class R2. None. rinderpest or FMD, or that have a Russia, Atlantic, Australia, Caribbean, Risk Class R3. None. contiguous border with countries Europe, Mexico, Middle America, Risk Class R4. None affected with rinderpest or FMD. Middle East, New Zealand, Oceania, Risk Class RU. All regions of the Because the current regulations do not South America.1 world except those specifically listed as distinguish between countries affected Risk Class R1. None. Risk Class RN, R1, R2, R3 or R4. with rinderpest and those affected with Risk Class R2. None. Contagious caprine pleuropneumonia FMD, at this time we cannot separate Risk Class R3. None. (Mycoplasma mycoides subsp. capri) those that import from countries that are Risk Class R4. None. Risk Class RN. All regions of Atlantic, infected with rinderpest but not with Risk Class RU. All regions of the Caribbean, Middle America, New FMD. We are proposing to include Fiji, world except those specifically listed as Zealand, North America, and South New Caledonia and Panama as Risk Risk Class RN, R1, R2, R3, or R4. America.1 Class R1 regions because they are Congo virus (Crimean Hemorrhagic Risk Class R1. None. adjacent to regions that are considered Disease). Risk Class R2. None. to be affected with FMD. Risk Class RN. All regions of Atlantic, Risk Class R3. None. Risk Class R2. Argentina. Caribbean, Middle America, New Risk Class R4. None. The effect of this classification would Zealand, North America, Oceania, and Risk Class RU. All regions of the be to allow the importation into the South America.1 world except those specifically listed as United States from Argentina of Risk Class R1. None. Risk Class RN, R1, R2, R3 or R4. ruminants and fresh, chilled, and frozen Risk Class R2. None. Epizootic hemorrhagic disease virus meat of ruminants. However, those Risk Class R3. None. of deer (Ibaraki) (except serotypes 1 and importations would be subject to certain Risk Class R4. None. 2). restrictions, as set forth in § 93.415 of Risk Class RU. All regions of the Risk Class RN. Canada, Europe, this proposal. This classification would world except those specifically listed as Mexico, New Zealand. Europe and New also relieve certain prohibitions and Risk Class RN, R1, R2, R3 or R4. Zealand have never reported the restrictions on the importation from Contagious agalactia of sheep and presence of this agent and there is no Argentina of milk and milk products of goats due to Mycoplasma agalactiae. evidence that it now exists or has ever ruminants. Risk Class RN. All regions of existed in these regions. Canada and We believe classifying Argentina as a Australia, Caribbean, Middle America, Mexico have been affected only by Risk Class R2 region for FMD is New Zealand, North America, South serotypes 1 and/or 2, which are endemic appropriate. The last outbreak of FMD America.1 in the United States. in Argentina occurred in 1994. Risk Class R1. None Risk Class R1. None. However, vaccinations for FMD in Risk Class R2. None. Risk Class R2. None. Argentina still continue. Additionally, Risk Class R3. None. Risk Class R3. None. Argentina supplements its national meat Risk Class R4. None. Risk Class R4. None. supply by importing fresh, chilled and Risk Class RU. All regions of the Risk Class RU. All regions of the frozen meat of ruminants and swine world except those specifically listed as world except those specifically listed as from countries listed in this proposed Risk Class RN, R1, R2, R3 or R4. Risk Class RN, R1, R2, R3 or R4. rule as Risk Class R3, R4 or RU. Contagious bovine pleuropneumonia Foot-and-mouth disease virus. Argentina also shares land borders with due to Mycoplasma mycoides var Risk Class RN. Australia; Barbados; Brazil and Bolivia, which are both mycoides (CBPP). Bermuda; all regions of North and designated in this proposed rule as Risk Risk Class RN. All regions of Atlantic, Middle America except Panama; all Class RU regions. Caribbean, Middle America, New regions of the Caribbean except The In determining the proposed Zealand, North America, and South Bahamas; Greenland, Iceland, Territory classification for Argentina, APHIS America. of St. Pierre and Miquelon, Trust reviewed the documentation submitted These regions have never reported the territory of the Pacific Islands. by the government of Argentina in presence of this agent, or the agent has These regions are listed in § 94.1(a)(2) support of its request to be considered been eradicated for more than 15 years. of the current regulations as countries free of FMD, and a team of APHIS (Brown C. Contagious Bovine free of both rinderpest and foot-and- officials traveled to that country in 1994 Pleuropneumonia, in Foreign Animal mouth disease. They are not listed in to conduct an on-site evaluation of the Diseases, edited by Buisch WW, Hyde current § 94.11(a) as countries that, country’s animal health program. The JL, Mebus CA. United States Animal because of importations of meat from or evaluation consisted of a review of Health Association, Richmond VA. 146– proximity to rinderpest or FMD-affected Argentina’s veterinary services, 151, 1992.) countries, are subject to restrictions on diagnostic procedures, vaccination Risk Class R1. Australia, all regions of importations of meat or meat products practices, and administration of laws Europe except Portugal and Spain. into the United States. and regulations intended to prevent the Europe has been free of CBPP for over Risk Class R1. Austria, The Bahamas, introduction of FMD into Argentina 15 years, except for recent outbreaks in Belgium, Chile, Denmark, Fiji, Finland, through the importation of animals, Portugal and Spain. Australia eradicated France, Germany, United Kingdom, meat, or animal products. The APHIS the disease in 1975, but the status of Hungary, Japan, New Caledonia, The officials conducting the on-site neighboring areas in Oceania is more Netherlands, Norway, Papua New evaluation concluded that Argentina is uncertain. Therefore, we have proposed Guinea, Panama, Poland, Portugal, a low risk region for FMD. (Details to classify Australia and all regions of Republic of Ireland, Republic of Korea, concerning the on-site evaluation are Europe as Risk Class R1 until further Sweden, Spain, Switzerland, and available from the person listed under data can be reviewed. (Clay AL, Lloyd Uruguay. FOR FURTHER INFORMATION LC. The Eradication of Contagious These regions are listed in § 94.11(a) CONTACT.’’) Bovine Pleuropneumonia from as countries free of rinderpest and FMD Based on our proposed risk Australia. Bull. Off. Inter. Epiz., 81(7/ that supplement their meat supply with classification of Argentina, meat and 8):533–546, 1975.) imports from countries affected with other animal products of ruminants or Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 16989 swine, as well as the ship’s stores, extensively with regions where hog on the north; the State of Baja California airplane meals, or baggage containing cholera is known to exist, we propose Norte, Mexico and the Gulf of California such meat or other animal products that these regions be classified as Risk on the west; The State of Chihuahua, originating in Argentina would be Class R1. Mexico on the east; and the State of subject to the restrictions specified in In June, 1994, the Department Sinaloa, Mexico on the south. The § 94.11 of these proposed regulations. received a request from the Chief border between Sonora and Chihuahua Risk Class R3. Greece and Italy. Animal Health Officials in the country is separated by the Sierra Madre Greece and Italy recently have had of Mexico for recognition of the State of mountains. There are few mountain localized outbreaks of FMD, which have Sonora as a region free of hog cholera passes crossing from Chihuahua to been controlled. Until more information under the sanitary and phytosanitary Sonora along this entire border, from the is available, we are proposing to classify provisions of the North American Free United States to Sinaloa, with only these countries as Risk Class R3 regions. Trade Agreement (NAFTA) and the minor road crossings at Puerto San Luis However, it is possible this General Agreement on Tariffs and Trade and Maycoba. The southern border of classifications could be limited to (GATT). the State of Sonora is separated for most smaller areas of these countries when Under the current regulations, there is of the eastern part of the border by the the situation is further reviewed under no provision for recognition of regions same mountains that separate it from the procedures provided in § 92.5 of this of a country as free of a disease if the Chihuahua. Major highway and rail proposal. entire country is not free of that disease. crossings near Estacion Don are on the Risk Class R4. None. However, such recognition would be coastal plain within a few miles of the Risk Class RU. All regions of the possible under this proposed rule. Gulf of California. This would meet the world except those specifically listed as Therefore, as a result of the request from requirements for a Risk Class R1 region Risk Class RN, R1, R2, R3 or R4. Mexico, a team of APHIS personnel for hog cholera according to § 92.3(b)(5) Getah virus. reviewed the request in accordance with of this proposed part. Risk Class RN. All regions of Africa, § 92.3 of this proposed rule. A site visit 5. All border access points from Atlantic, Caribbean, Europe, Middle by personnel from APHIS was adjacent States of Mexico are controlled America, Middle East, New Zealand, conducted on October 24–28, 1994, to prevent movement of swine or swine North America, and South America.1 which confirmed the facts of the request products into the State of Sonora. The Risk Class R1. None. from the Mexican government.2 only major ports with other States of Risk Class R2. None. Therefore, in this proposed rule, we Mexico are to Sinaloa on Mexico Risk Class R3. None. are proposing that the State of Sonora in Federal Highway 15 near Estacion Don, Risk Class R4. None. the country of Mexico be included as a Sonora, Mexico, and a rail crossing near Risk Class RU. All regions of the Risk Class R1 region for hog cholera, the same town. Estacion Don has world except those specifically listed as because we believe the region meets washing and disinfection facilities for Risk Class RN, R1, R2, R3 or R4. some of the criteria for a Risk Class RN livestock trucks entering Sonora, cattle Heartwater due to rickettsia Cowdria region for hog cholera, and some of the corrals and dipping facilities for tick ruminantium. criteria for an R1 region according to control, and an incinerator for Risk Class RN. All regions of Asia, § 92.3 of this proposed rule. confiscated meats. Swine are not Atlantic, Australia, Europe, Middle We believe this classification would allowed to enter through this port from America, Middle East, New Zealand, be warranted due to the following facts: other areas of Mexico. The disinfection North America, Oceania, and South 1. Hog cholera virus has not been of trucks that have carried swine is America.1 diagnosed in Sonora, Mexico for 10 funded by the pork producers Risk Class R1. None. years (since 1985). This would meet the associations of Sonora. Other road and/ Risk Class R2. None. requirements for a Risk Class RN or rail crossings are near San Luis, Risk Class R3. None. (negligible risk) region for hog cholera Sonora, Mexico, and Riito, Sonora, Risk Class R4. None. according to § 92.3(a)(1) of this Mexico, where bridges cross the Risk Class RU. All regions of the proposed rule. Colorado river from Sonora to Baja world except those specifically listed as 2. Hog cholera virus is currently not California Norte, Mexico, and to Puerto Risk Class RN, R1, R2, R3 or R4. known to exist in any of the States of San Luis and Maycoba where minor Hog cholera (classical swine fever). Mexico or the United States that adjoin roads cross from the State of Chihuahua, Risk Class RN. Australia, Canada, the State of Sonora, Mexico. This would Mexico. Inspection procedures for Dominican Republic, Fiji, United meet the requirements of a Risk Class trucks moving from Chihuahua are Kingdom, Iceland, New Zealand, RN region for hog cholera according to similar to those for trucks moving from Norway, the Republic of Ireland, § 92.3(a)(2) of this proposed rule. Sinoloa at Estacion Don. Airports with Sweden, and Trust Territory of the 3. Vaccination for hog cholera has commercial connections to other areas Pacific Islands. been prohibited since 1989. This would of Mexico include numerous local These regions are listed in §§ 94.9 and meet the requirements for a Risk Class airports and 3 international airports 94.10 of the current regulations as R1 (slight risk) region for hog cholera located at Obregon, Hermosillo, and countries where hog cholera does not according to § 92.3(b)(4) of this Guaymas. The principle seaport is exist, and they neither are adjacent to proposed rule. located at Guaymas on the Gulf of nor trade extensively with regions 4. Adjacent States of Mexico are California. This would meet the where hog cholera is known to exist. separated by natural physical barriers or requirements for a Risk Class R1 region Risk Class R1. Denmark, Finland, manmade fences. The State of Sonora, for hog cholera according to § 92.3(b)(6) Spain, and the State of Sonora in Mexico is bordered by the United States of this proposed rule. Mexico. 6. Movement of swine and swine Denmark, Finland, and Spain are 2 Copies of the State of Sonora site visit report products into the State of Sonora from listed in §§ 94.9 and 94.10 of the current may be obtained from USDA, APHIS, National other States of Mexico has been Center for Import and Export, 4700 River Road Unit regulations as countries where hog 39, Riverdale, MD 20837–1231. Requests may be reviewed by the Administrator and cholera does not exist. However, made by telephone to (301) 734–7511 or by FAX to appears to meet the same level of because they are adjacent to or trade (301) 734–6402. biosecurity as required in proposed 16990 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

§ 93.515(e)(1) of this chapter. This Risk Class R2. None. Risk Class R1. None. would meet the requirements for a Risk Risk Class R3. None. Risk Class R2. None. Class R1 region for hog cholera Risk Class R4. None Risk Class R3. None. according to § 92.3(b)(7) of this Risk Class RU. All regions of the Risk Class R4. None. proposed part. world except those specifically listed as Risk Class RU. All regions of the 7. The State of Sonora maintains a Risk Class RN, R1, R2, R3 or R4. world except those specifically listed as passive surveillance system that Lumpy skin disease (Neethling virus). Risk Class RN, R1, R2, R3 or R4. includes reporting all suspect cases in Risk Class RN. All regions of Asia, Nairobi sheep disease (Ganjam, back yard herds and commercial herds. Atlantic, Australia, Caribbean, Europe, Dugbe) virus. The state of Sonora also has active Middle America, New Zealand, North Risk Class RN. All regions of Atlantic, surveillance that consists of periodic America, Oceania, and South America. Australia, Caribbean, Europe, Middle surveys of swine on farms and at Risk Class R1. None. America, Middle East, New Zealand, slaughter plants. In a serological survey, Risk Class R2. None. North America, Oceania, and South Risk Class R3. None. 50 percent of the commercial operations America.1 Risk Class R4. None. Risk Class R1. None. were sampled in 1991, and 25 percent Risk Class RU. All regions of the Risk Class R2. None. of the commercial operations were world except those specifically listed as sampled in 1993. No evidence of hog Risk Class R3. None. Risk Class RN, R1, R2, R3 or R4. Risk Class R4. None. cholera was found in these surveys. Malignant catarrhal fever virus Risk Class RU. All regions of the These surveys did not include small (wildebeest form). backyard operations. Continuous Risk Class RN. All regions of Asia, world except those specifically listed as monitoring of swine at slaughter plants Atlantic, Australia, Caribbean, Europe, Risk Class RN, R1, R2, R3 or R4. Parafilariosis due to Parafilaria is planned until the State of Sonora Middle America, Middle East, New bovicola. achieves recognition as a Risk Class RN Zealand, North America, Oceania, and Risk Class RN. All regions of North region for hog cholera according to South America.1 § 92.3(a) of this proposed part. Passive America, Middle America, South Risk Class R1. None. 1 and active surveillance in the State of Risk Class R2. None. America and Caribbean. Sonora would meet the requirements for Risk Class R3. None. Risk Class R1. None. a Risk Class R1 region for hog cholera Risk Class R4. None. Risk Class R2. None. according to § 92.3(b)(8) of this Risk Class RU. All regions of the Risk Class R3. None. proposed rule. world except those specifically listed as Risk Class R4. None. 8. The laws, regulations, policies, and Risk Class RN, R1, R2, R3 or R4. Risk Class RU. All regions of the infrastructure in the State of Sonora and Mycobacterium bovis. world except those specifically listed as the country of Mexico have been Risk Class RN. Bermuda, The Risk Class RN, R1, R2, R3 or R4. reviewed by the Administrator and are Bahamas, Falkland Islands, Peste des petits ruminants (Kata) believed to be adequate to maintain Luxembourg, Norway, Isle of Jersey virus. surveillance and control and to (United Kingdom), Cyprus. Risk Class RN. All regions of Atlantic, eradicate hog cholera rapidly in the These regions have reported complete Europe, North America, South America, 1 event of any outbreaks in the State of absence of bovine tuberculosis for over Australia, and Oceania. Sonora, and to curtail and restrict 15 years. (Regional and Country Status Risk Class R1. None. movements of swine or swine products Reports, in ‘‘Mycobacterium bovis Risk Class R2. None. from any other regions of Mexico where Infection in Animals and Humans,’’ Risk Class R3. None. hog cholera exists. This would appear to Edited by Thoen, C.D. and Steele, J.H., Risk Class R4. None. Risk Class RU. All regions of the meet the requirements for a Risk Class pp. 169–345, Iowa State University world except those specifically listed as R1 region for hog cholera according to Press, Ames Iowa, 1995). Risk Class RN, R1, R2, R3 or R4. § 92.3(b)(9) of this proposed rule. Risk Class R1. None. Risk Class R2. None. Risk Class R2. Canada. Pseudomonas pseudomallei Risk Class R3. None. All Provinces of Canada are either (melioidosis). Risk Class R4. None. accredited-free or modified-accredited Risk Class RN. All regions of Europe, Risk Class RU. All regions of the for bovine tuberculosis. Accredited-free Canada, and Atlantic.1 world except those specifically listed as provinces could be classified as Risk Risk Class R1. None. Risk Class RN, R1, R2, R3 or R4. Class R1 regions, and modified- Risk Class R2. None. Japanese encephalitis virus. accredited as Risk Class R2 if at least 1 Risk Class R3. None. Risk Class RN. All regions of Africa, year has elapsed without the discovery Risk Class R4. None. Atlantic, Caribbean, Europe, Middle of any infected herds. Canada follows a Risk Class RU. All regions of the America, Middle East, New Zealand, tuberculosis eradication program world except those specifically listed as North America, and South America.1 equivalent to that conducted in the Risk Class RN, R1, R2, R3 or R4. Risk Class R1. None. United States. Other countries may be Pseudorabies (Aujesky’s) virus. Risk Class R2. None. equivalent to Canada, but we currently Risk Class RN. None. Risk Class R3. None. cannot evaluate their status. Risk Class R1. Canada. Risk Class R4. None. Risk Class R3. None. Canada eradicated pseudorabies over Risk Class RU. All regions of the Risk Class R4. None. 15 years ago. However, because it is world except those specifically listed as Risk Class RU. All regions of the adjacent to the United States, which is Risk Class RN, R1, R2, R3 or R4. world except those specifically listed as affected with pseudorabies, we are Jembrana (Tabanan) virus. Risk Class RN, R1, R2, R3 or R4. proposing to classify Canada as a Risk Risk Class RN. All regions of Africa, Near east encephalomyelitis virus. Class R1 region for this disease, which Atlantic, Caribbean, Europe, Middle Risk Class RN. All regions of Atlantic, would be equivalent in status to America, Middle East, New Zealand, Australia, Caribbean, Europe, Middle pseudorabies-free States in the United North America, and South America.1 America, New Zealand, North America, States. Risk Class R1. None. Oceania, and South America.1 Risk Class R2. None. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 16991

Risk Class R3. None. supplemented from a rinderpest or from Risk Class R4. None. Risk Class R4. None. an FMD-affected country, we cannot Risk Class RU. All regions of the Risk Class RU. All regions of the separate those that import from world except those specifically listed as world except those specifically listed as countries infected with foot-and-mouth Risk Class RN, R1, R2, R3 or R4. Risk Class RN, R1, R2, R3 or R4. disease but not rinderpest. Fiji and New Taenia (Multiceps) multiceps (dog Restricted ectoparasites. Caledonia would be classified as Risk tapeworm) in livestock handling dogs. Risk Class RN. Canada.1 Class R1 for rinderpest because they are Risk Class RN. All regions of North Risk Class R1. None. adjacent to regions that are considered America, Middle America, and Risk Class R2. None. to be infected with rinderpest. Caribbean.1 Risk Class R3. None. Risk Class R2. None. Risk Class R1. None. Risk Class R4. None. Risk Class R3. None. Risk Class R2. None. Risk Class RU. All regions of the Risk Class R4. None. Risk Class R3. None. world except those specifically listed as Risk Class RU. All regions of the Risk Class R4. None. Risk Class RN, R1, R2, R3 or R4. world except those specifically listed as Risk Class RU. All regions of the Rift Valley fever virus. Risk Class RN, R1, R2, R3 or R4. world except those specifically listed as Risk Class RN. All regions of Asia, Scrapie disease agent. Risk Class RN, R1, R2, R3 or R4. Atlantic, Australia, Caribbean, Europe, Risk Class RN. All regions of Australia Teschen disease virus. Middle America, New Zealand, North and New Zealand.1 Risk Class RN. All regions of Africa, America, Oceania, and South America.1 Risk Class R1. None. Asia, Atlantic, Australia, Caribbean, Risk Class R1. None. Risk Class R2. None. Middle America, Middle East, New Risk Class R2. None. Risk Class R3. Canada. Zealand, North America, Oceania, and Risk Class R3. None. Scrapie exists at a low prevalence in South America.1 Risk Class R4. None. Canada, which has a program to Risk Class R1. None. Risk Class RU. All regions of the eradicate this disease that is equivalent Risk Class R2. None. world except those specifically listed as to the scrapie eradication program in the Risk Class R3. None. Risk Class RN, R1, R2, R3 or R4. United States. Risk Class R4. None. Rinderpest virus. Risk Class R4. None. Risk Class RU. All regions of the Risk Class RN. Australia; Bermuda; all Risk Class RU. All regions of the world except those specifically listed as regions of North America, Middle world except those specifically listed as Risk Class RN, R1, R2, R3 or R4. America, South America except Chile, Risk Class RN, R1, R2, R3 or R4. Theileriosis (east coast fever, corridor and the Caribbean except The Bahamas; Sheep pox and/or goat pox virus. disease, Mediterranean fever). Greenland; Iceland; New Zealand; Risk Class RN. All regions of Atlantic, Risk Class RN. All regions of Atlantic, Territory of St. Pierre and Miquelon; Australia, Caribbean, Middle America, Asia, Australia, Caribbean, Europe, and Trust Territory of the Pacific New Zealand, and North America.1 Middle America, Middle East, New Islands. Risk Class R1. None. Zealand, North America, Oceania, and 1 These regions are currently listed in Risk Class R2. None. South America. § 94.1(a)(2) as countries free of both Risk Class R3. None. Risk Class R1. None. rinderpest and FMD. They are not listed Risk Class R4. None. Risk Class R2. None. in current § 94.11(a) as countries that, Risk Class RU. All regions of the Risk Class R3. None. Risk Class R4. None. because of importations of meat from or world except those specifically listed as Risk Class RU. All regions of the proximity to rinderpest or FMD-affected Risk Class RN, R1, R2, R3 or R4. world except those specifically listed as countries, are subject to restrictions on Swine vesicular disease. importations of meat or meat products Risk Class RN. Australia, all regions of Risk Class RN, R1, R2, R3 or R4. Tick-borne encephalitis (louping ill, into the United States. We are proposing North America, Middle America, Central European encephalitis) virus. to include South America and the Dominican Republic, Fiji, Finland, Risk Class RN. All regions of Africa, Caribbean as Risk Class RN regions for Greenland, Haiti, Iceland, New Zealand, Atlantic, Australia, Caribbean, Middle rinderpest because they have never Norway, Rumania, Sweden, and Trust America, Middle East, New Zealand, reported rinderpest and there is no Territory of the Pacific Islands. North America, Oceania, and South reason to believe these regions are now These regions are listed in § 94.12 of America.1 or have ever been infected with the current regulations as countries Risk Class R1. None. rinderpest. where swine vesicular disease does not Risk Class R2. None. Risk Class R1. Austria, The Bahamas, exist, and are not listed in current Risk Class R3. None. Belgium, Channel Islands, Chile, § 94.13 as countries that supplement Risk Class R4. None. Denmark, Finland, France, Germany, their pork supply from countries Risk Class RU. All regions of the United Kingdom, Hungary, Japan, The affected with swine vesicular disease. world except those specifically listed as Netherlands, Norway, Papua New Risk Class R1. Austria, The Bahamas, Risk Class RN, R1, R2, R3 or R4. Guinea, Poland, Republic of Ireland, Bosnia-Herzogovania, Bulgaria, Chile, Tick-borne fever due to Erlichia Republic of Korea, Spain, Sweden, Fiji, Croatia, Denmark, Finland, Hungary, (Cytoecetes) phagocytophilia. New Caledonia. Luxembourg, Macedonia, Republic of Risk Class RN. All regions of Atlantic, These regions are listed in current Ireland, Slovenia, Switzerland, United Australia, Caribbean, Middle America, § 94.11(a) as countries that are free of Kingdom, and Yugoslavia. Middle East, New Zealand, North both rinderpest and FMD, but that These regions are listed in § 94.12 as America, Oceania, and South America.1 supplement their meat supply with countries free of swine vesicular Risk Class R1. None. imports from areas affected with disease, but are listed in § 94.13 as Risk Class R2. None. rinderpest or FMD, or that share borders countries that supplement their national Risk Class R3. None. with countries affected with rinderpest pork supply from countries that are Risk Class R4. None. or FMD. Because the current regulations affected with swine vesicular disease. Risk Class RU. All regions of the in § 94.11 do not distinguish whether a Risk Class R2. None. world except those specifically listed as country’s meat supply is being Risk Class R3. None. Risk Class RN, R1, R2, R3 or R4. 16992 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

African (salivarian- or tsetse- Proposed Part 93 In setting forth specific importation transmitted) Trypanosoma spp. (T. Current 9 CFR part 93 contains criteria in proposed part 93, we would brucei, T. congolense, T. evansi, T. suis, provisions governing the importation of refer to the various risk classification T. simiae, T. uniforme, T. vivax). elephants, hippopotami, rhinoceroses, levels set forth in proposed part 92, Risk Class RN. All regions of Asia, and tapirs into the United States. As discussed above under the heading Atlantic, Australia, Caribbean, Europe, discussed above in this ‘‘Supplementary ‘‘Criteria for Risk Classification.’’ The Middle America, Middle East, New Information’’ under the heading ‘‘Parts discussion that follows in this Zealand, North America, Oceania, and SUPPLEMENTARY INFORMATION explains 1 92 and 93,’’ we are proposing to keep South America. these provisions in part 93, and are also what would be required to import Risk Class R1. None. proposing to add to part 93 the specific types of animals from each Risk Class R2. None. provisions regarding the importation of region based on the region’s risk Risk Class R3. None. classification for the disease in question. Risk Class R4. None. birds, poultry, horses, ruminants, swine, Risk Class RU. All regions of the dogs, and hedgehogs and possums that Removal of Country-By-Country world except those specifically listed as are currently set forth in part 92. These Exemptions Risk Class RN, R1, R2, R3 or R4. provisions would be grouped according Subparts D and E of part 92 of the Trypanosoma spp. transmitted by to the same subpart designations as in current regulations restrict the vectors other than tsetse flies (NTT- current part 92 (e.g., provisions importation of ruminants and swine Trypanosomas). regarding the importation of birds from various countries, due to the Risk Class RN. All regions of Asia, would continue to be subpart A, existence of certain animal diseases in Atlantic, Australia, Europe, Middle provisions for poultry would continue those countries. For the most part, the America, Middle East, New Zealand, to be subpart B, etc.), and the current regulations are structured so that the and North America.1 part 93 provisions for elephants, restrictions are applied to a list of Risk Class R1. None. hippopotami, rhinoceroses, and tapirs countries in which the diseases in Risk Class R2. None. would be designated as subpart H. question exist. However, because of Risk Class R3. None. The only changes to the provisions for individual circumstances particular to Risk Class R4. None. elephants, hippopotami, rhinoceroses, several individual countries, some of Risk Class RU. All regions of the and tapirs would be to correct cross the provisions of the regulations refer world except those specifically listed as references and to amend the definitions only to those countries. These include Risk Class RN, R1, R2, R3 or R4. and the introductory text to the provisions for the importation of Vesicular stomatitis virus. definitions section to bring the language ruminants and swine from Canada in Risk Class RN. All regions of Africa, in line with that in the other subparts. current §§ 92.417, 92.418, 92.419, Asia, Atlantic, Australia, Caribbean, Aside from being moved to part 93, the 92.420, 92.421, 92.516, 92.517, 92.518, Europe, Middle East, New Zealand, regulations regarding birds (subpart A), and 92.519; from the Caribbean North America except Mexico, and poultry (subpart B), horses (subpart C), 1 countries in §§ 92.422, 92.423, and Oceania. dogs (subpart F), and hedgehogs and 92.520; and from Mexico in §§ 92.424, Risk Class R1. None. possums (subpart G) would be changed 92.425, 92.426, 92.427, 92.428, 92.429, Risk Class R2. None. only to correct cross references. The and 92.521. They also include Risk Class R3. None. only changes to those subparts would be Risk Class R4. None. provisions for the importation of cattle to correct cross references. Risk Class RU. All regions of the from the Republic of Ireland in § 92.432, However, in this proposal, we are world except those specifically listed as and for sheep from New Zealand in proposing significant substantive Risk Class RN, R1, R2, R3 or R4. §§ 92.433. changes to the provisions of subpart D Wesselsbron virus. In this proposed rule, we do not Risk Class RN. All regions of Asia, (ruminants) and subpart E (swine) in include special provisions for specific Atlantic, Australia, Caribbean, Europe, current part 92. These changes would be countries, but rather we set forth Middle America, Middle East, New in accordance with NAFTA and GATT requirements for importation that would Zealand, North America, Oceania, and provisions regarding the assessment of apply to all countries or regions that South America.1 the risk of importing animals and meet the criteria for a particular risk Risk Class R1. None. animal products from foreign regions. classification for a specific restricted Risk Class R2. None. In subparts D and E of proposed part agent. In some cases, these criteria may, Risk Class R3. None. 93, we would set forth specific criteria practically speaking, apply to only one Risk Class R4. None. for the importation of ruminants and or two countries—for instance, Risk Class RU. All regions of the swine from foreign regions, based on the countries that import into the United world except those specifically listed as risk classification of a region for a States through land border ports Risk Class RN, R1, R2, R3 or R4. particular restricted agent, and on the (discussed below under the heading type of animal intended for importation. ‘‘Exemption from Import Permit Application for Risk Class Recognition (Unlike current part 92, no criteria for Requirements’’). However, we believe it Section 92.5 of this proposed rule the importation of animal products is appropriate not to refer to individual contains procedures for applying for would be included in proposed part 93. countries in this proposal, in light of the recognition of a risk class for a region, Those provisions that currently appear requirement in GATT that sanitary and procedures that would be followed by in part 92 regarding products would be phytosanitary measures must not APHIS in making a determination of a incorporated into part 94, and would be arbitrarily or unjustifiably discriminate region’s risk class, and provisions for revised as necessary to accommodate between members where identical or the removal or change of status of a our proposed changes to regionalization similar conditions prevail (Agreement region due to a failure of the region to and risk assessment. These revised on the Application of Sanitary and meet the criteria of its current risk class, criteria for the importation of animal Phytosanitary Measures, GATT, article or due to the discovery of a restricted products are discussed in this 2, paragraph 3). In future rulemaking, agent in a Risk Class RN, R1, or R2 SUPPLEMENTARY INFORMATION in the we would adapt the regulations to region. discussion of changes to part 94.) recognize regions that do not meet any Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 16993 of the risk categories we are proposing African swine fever, or swine vesicular certificate issued in the country of to establish in this document. In such disease. These provisions would apply origin. This document must certify that future rulemaking, we would establish only to animals being imported by land the ruminants and swine have been in classifications appropriate to that risk from either Canada or Mexico. We the country of origin for at least 60 days posed by those regions. Any other believe these exemptions are warranted, immediately preceding the date of region that meets the criteria established because, if the animals are found upon intended exportation from that country, for a new risk classification would be inspection at the port of entry to be and must also certify that the country or assigned that same classification. affected with any communicable district of origin has been free of certain disease, the animals are not accepted specified diseases during that 60-day General Prohibitions; Inspection; into the United States, whereas animals period. In addition, the certificate for Importation Ports transported to the United States by air sheep and goats must contain certain In the current regulations, §§ 92.401, or ship are difficult and costly to return statements related to scrapie. 92.402, and 92.403 (ruminants), and to their origin, and holding them at the In this proposed rule, in §§ 93.405 §§ 92.501, 92.502, and 92.503 (swine) quarantine facility may create a space (ruminants) and 93.505 (swine), we include, respectively, provisions problem. would require that all ruminants and regarding general import prohibitions, Import permits are used primarily as swine imported, except for ruminants the inspection, unloading, and cleaning reservations for space in the quarantine and swine imported for immediate of means of conveyance; and ports for stations. The need for permits for slaughter from regions classified as RN importation. In this proposal, these importation at facilities other than land for all restricted disease agents of sections would be redesignated as being border ports is to assure that the port ruminants and swine, respectively, must in part 93, but would remain facilities have sufficient space to handle be accompanied by a certificate of substantively unchanged. animals as they are imported. At land export. This certificate of export, which Import Permit Requirements border ports there may be a limited would have to be issued and signed by amount of space, but the animals can be an authorized veterinarian and endorsed Under the current regulations, with unloaded on the Canadian or Mexican by an official of the National Veterinary certain exceptions, before ruminants side of the border until space becomes Services of the country of export, would and swine may be imported into the available. It is not possible to hold need to certify that the ruminants or United States, the importer must first animals for any length of time on planes swine originate from premises that are apply for and obtain from APHIS an or ships at other ports. not known to have been affected with import permit. The requirements for an In the current regulations, any communicable disease or restricted application for the import permit are set § 92.404(a)(2) includes the statement ectoparasites of the type of animal in forth in the current regulations in that ‘‘An application for permit to question for the previous 60 days. The §§ 92.404 and 92.504 for ruminants and import will be denied for domestic certificate would also need to state that swine, respectively. On the application, ruminants from any country where it during transportation to the port of the importer must include information has been declared, under section 306 of embarkation, there was no direct or regarding the type, number, and the Act of June 17, 1930, that foot-and- indirect exposure to potential carrier identification of the animals to be mouth disease (FMD) or rinderpest has animals from any region affected with imported, and information on the origin, been determined to exist, except as restricted disease agents; that while en intended arrival, route, and destination provided in § 92.430.’’ Section route to the port of entry, the animals of the animals. These requirements are 92.504(a)(2) includes a like statement were not trailed or driven through any the same in this proposal. for swine. In §§ 93.404 and 93.504 of Risk Class R3, R4, or RU region for (i.e., Under the current regulations, this proposal, we are not including this region affected by) any tick-borne however, an import permit is not statement. While it is true that restricted diseases; and that while en required, under certain conditions, for ruminants and swine may not be route to the port of entry, the animals ruminants or swine from certain imported, without stringent restrictions, were not trailed, driven, transported, or specified countries or areas of the world from countries at high risk for such otherwise moved through any Risk Class (e.g., Canada, Mexico, the West Indies, animals being affected with FMD or R3, R4, or RU region for any restricted and Central America). In this proposed rinderpest, we believe it is misleading to insect-transmitted diseases during a rule, we are not setting forth permit imply that such importations are time of year when insect vectors are exemptions for specifically named prohibited except in rare cases. Under active. Finally, the certificate would countries or regions, because of the need §§ 93.415 and 93.515 of this proposed need to certify that the animals either for general applicability of requirements rule, ruminants and swine imported were inspected on the day of as discussed above. However, we from regions classified as R3, R4, or RU embarkation and were found to be free continue to believe that certain for FMD and rinderpest would be of restricted ectoparasites, or were importations from countries with land required to be quarantined at the Harry treated for ectoparasites within 10 to 14 border ports to the United States can be S Truman Animal Import Center days of embarkation. carried out without the need for import (HSTAIC), just as is required under the As noted above, only ruminants or permits, for the reasons discussed current regulations for ruminants and swine that are from Risk Class RN below. swine from countries where FMD or (negligible risk) regions for all restricted In §§ 93.404 and 93.504 of this rinderpest exists. disease agents of ruminants or swine, proposal, we are setting forth provisions respectively, and that are imported for that would exempt certain ruminants or Certificate Requirements immediate slaughter would be swine presented at a land border port In the current regulations, §§ 92.405 exempted from the requirements for a from the import permit requirements. (ruminants) and 92.505 (swine) require certificate of export. Most ruminants or To be eligible for this exemption, the that, with certain exceptions based on swine would still be required to have a animals would have to originate in whether the animals come from certificate of export even though they regions that are not known to be affected specifically named countries of origin, may not be required to have an import with foot-and-mouth disease and ruminants and swine imported into the permit under proposed §§ 92.404 and rinderpest, and for swine, hog cholera, United States be accompanied by a 92.504. 16994 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

The value of the required certification §§ 93.415 and 93.515 of this proposed Requirements for Importation Based on would be dependent on the integrity rule include quarantine requirements Disease Risk and quality of inspections in the specific to the risk class of the region of As discussed above in this exporting country. The animal health origin and the disease in question, it ‘‘Supplementary Information’’ under the infrastructure of a country is a factor in would no longer be adequate or heading ‘‘Parts 92 and 93,’’ the current assigning a risk classification to a appropriate to have a uniform length of regulations in part 92 include region. For regions with higher risk, quarantine, as currently is the case with restrictions on the importation of certain quarantine or testing requirements swine, or, alternatively, to refer to ruminants and swine due to their risk of validate the export certification. specific countries, as currently is the transmitting diseases to animals in the case with ruminants. The quarantine Current §§ 92.407/92.506 United States. Current part 92, in requirements for animals from any general, bases restrictions on In the current regulations, §§ 92.407 particular country or region would be (ruminants) and 92.506 (swine) set forth importation on whether a disease in governed by the risk class of the region question is considered to exist or not provisions regarding the presentation of of origin. certificates, declarations, and affidavits exist in a particular country. In this proposed rule, we are required by the regulations. These Current §§ 92.412/92.511 and 92.413/ proposing to move from a country-by- provisions are set forth in §§ 93.406 and 92.512 country approach to one based on 93.506 of this proposal, and except for Under the current regulations, individual regions, and are also the addition of clarification as to which §§ 92.412 and 92.413 (ruminants) and proposing to substitute a gradation of documents are being referred to, would §§ 92.511 and 92.512 (swine) include risk levels for an ‘‘exist/does not exist’’ remain unchanged. requirements regarding importation consideration of disease risk. Current §§ 92.408/92.507 quarantine facilities. These provisions Restrictions on the importation of are set forth in §§ 93.411 and 93.412 ruminants and swine from regions, The current regulations in §§ 92.408 (ruminants) and §§ 93.511 and 93.512 (ruminants) and 92.507 (swine) contain based on risk level, are set forth in this (swine) of this proposed rule and would proposed rule in §§ 93.415 (ruminants) requirements for the inspection, at the remain unchanged. port of entry, of imported ruminants and and 93.515 (swine). The requirements swine. These requirements are set forth Current §§ 92.414/92.513 and 92.415/ for a particular importation would in §§ 93.407 and 93.507 of this proposed 92.514 depend on three factors: (1) The type of animal to be imported; (2) the disease in rule, and would be amended in one Under the current regulations, respect. The inspection requirements in question; and (3) the risk classification §§ 92.414 and 92.415 (ruminants) and level of the region from which the current §§ 92.408 and 92.507 refer to §§ 92.513 and 92.514 (swine) set forth, certain exceptions for animals from animals are to be imported. As the risk respectively, provisions regarding milk increases that unrestricted importations specific countries—i.e., Canada, Mexico, and manure from quarantined animals. and the British Virgin Islands when from a region will result in disease These provisions are set forth in transmission, the need for greater importing into the United States Virgin §§ 93.413 and 92.414 (ruminants) and Islands. In accordance with GATT, these import restrictions also increases. To §§ 92.513 and 92.514 (swine) of this mitigate disease risk, several broad risk exceptions for specific countries would proposed rule and would remain be removed. management options, applied unchanged. individually or in combination, are Current §§ 92.409/92.508 and 92.410/ Appearance of Disease Among available. These options can be applied 92.509 Ruminants in Quarantine to either animals or their products. The The current regulations in §§ 92.409 risk management options available are: (ruminants)/92.508 (swine) and In the current regulations, §§ 92.416 1. Certification of origin of animals §§ 92.410/92.509 set forth requirements (ruminants) and 92.515 (swine) provide and animal products. regarding articles accompanying that if any contagious disease appears 2. Tests and inspection of imported imported animals and regarding among the animals in quarantine, animals or products. movement from conveyances to special precautions must be taken to 3. Tests and inspection of herds or quarantine stations. These provisions prevent the spread of the infection to premises of origin. are set forth in §§ 93.408 and 93.509 other animals in the quarantine station 4. Treatment of animals or products. (ruminants) and §§ 93.508 and 93.509 of or those outside the grounds. Under this 5. Quarantine of imported animals. this proposal, and would remain provision, the Administrator may take 6. Restricted use or movement of unchanged. action to deal with outbreaks of clinical imported animals or products to reduce disease while the animals are in costs of failure. Current §§ 92.411/92.510 quarantine. These provisions are in In this proposed rule each of these The current regulations in §§ 92.411 proposed §§ 93.414 (ruminants) and management options is used for various (ruminants) and 92.410 (swine) include 93.514 (swine). disease agents. Not all of the options are quarantine requirements for ruminants Additionally, the proposed rule appropriate for every disease agent, so and swine, respectively, imported into would provide that, if there are test- different strategies will be necessary for the United States. The length of positive animals during quarantine (in different agents. Some of the required quarantine for swine as set the absence of clinical signs of disease), variabilities of the disease agents forth in current § 92.410 is the same (15 the Administrator may require include: days) no matter what the origin of the additional testing of both the test- 1. Incubation period. swine. However, the length of required positive and the test-negative animal(s). 2. Duration of carrier status in quarantine for ruminants varies We believe that this provision is animals. according to which country the necessary because many diseases are not 3. Number of potential host species ruminants originated in. immediately manifested in a clinical that may be affected. Under this proposed rule, these form and depend upon serological or 4. Survivability of agent outside the provisions would be removed. Because other tests for diagnosis in live animals. host animal. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 16995

5. Effectiveness of available test such regions would ensure that the of animals in source herds would be procedures to detect the disease agent. animals intended for export are not considered to be more uncertain, and 6. Effectiveness of available treatment vaccinated, and would ensure that more difficult for the veterinarians in procedures to eliminate the disease animals from other higher risk regions the region of origin to certify. The agent. are not presented as being from the Risk likelihood of incubating animals, 7. Availability of technology to Class R2 regions. Again, such testing innately resistant animals, or animals eradicate agent if it were introduced. would provide some additional active that have been vaccinated and not 8. If agent were introduced, potential surveillance for the exporting region. identified as such would be greater than cost to eradicate, or potential costs into Requiring a serological test at the U.S. for Risk Class R3 regions. The pre- perpetuity if agent cannot be eradicated. post-importation quarantine facility embarkation quarantine and testing Rationale for Import Requirements for would ensure that animals have not would be generally the same as for R3 Ruminants and Swine from Differing been exposed to a restricted disease regions, but the post-importation Risk Class Levels agent during pre-embarkation quarantine may require using U.S.- quarantine, and that any incubating source sentinel animals that would be Although the import requirements in animals during the pre-embarkation highly susceptible to any foot-and- this proposal differ for different animals quarantine period have had ample mouth disease, hog cholera, African and diseases, a broad model of opportunity to develop antibodies to the swine fever, or swine vesicular disease requirements based on risk class levels disease. virus that may be shed by infected can be drawn, and we believe that Risk Class R3 Regions: Risk Class R3 animals in the shipment. A 30- to 60- certain generalizations can be made regions would be low prevalence day pre-embarkation and post- about the type of mitigation measures regions with a good history of disease importation quarantine period would be necessary for each risk class level. In surveillance and control. Herds would necessary to detect these agents. general, the measures established for be identified that are free of the each level of risk are built upon the contagious disease of concern. Although Solicitation of Information protections proposed for levels of lesser the risk of importing a restricted disease The following proposed import risk. For example, the requirements for agent from an established herd is small, requirements have been formulated importation from a region classified as the risk of disease exposure to such a based on current import requirements R4 for foot-and-mouth disease would herd while in transit or while being and the most recent epidemiological incorporate and add to the requirements assembled is much higher. Due to the data available to us. We welcome for an R3 region. The requirements for incubation period for many of the information from the public, supported an R3 region would incorporate and add diseases of concern, the proposed by scientific evidence or other data, to the requirements for an R2 region, requirements for Risk Class R3 regions regarding the proposed requirements. and so on. The rationale for the broad would generally require a 30- to 60-day Requirements for Importation From requirements for each Risk Class level pre-embarkation quarantine period for Risk Class RN Regions are as follows (specific requirements for animals assembled. We believe this specific diseases are discussed later in would be necessary to detect any Although, for the most part, the this Supplementary Information under incubating animals, depending upon the importation restrictions in proposed the heading ‘‘Risk Level Classifications disease. Although vaccination is often §§ 93.415 and 93.515 vary according to other than Risk Level RN’’): an important method of control of some the restricted agent in question, the Risk Class R1 Regions: From a Risk contagious diseases, we would be requirement for one risk class level, that Class R1 region, there should be no concerned that vaccinated animals may of RN for negligible risk, would be the concern about possible residual mask a low prevalence of disease in the same for all diseases. This requirement, infection in the region. The principal herd. Therefore, we would expect that set forth in §§ 93.415(a) (ruminants) and concern is the possible deliberate animals being prepared for export 93.515(a) (swine), would be a introduction of animals into this region would not be vaccinated and would certification that the animal in question from regions with higher risk serve as sentinels for possible residual have only been on premises in RN classifications in order to qualify them infection in the source herd. regions. A region that is classified as RN as animals from a Risk Class R1 region. Unvaccinated animals would therefore for all restricted disease agents would be Requiring a negative serological test for be more likely to develop disease during able to import animals into the United any animals imported from R1 regions the pre-embarkation quarantine, but this States without any quarantine or testing would ensure that animals offered for would also serve to monitor the requirements. Such animals would still importation are not vaccinated, and that presence of any agent that may be need to be inspected at the U.S. port of animals from regions of higher risk are introduced into the quarantine center. If entry for the general freedom from not being presented as being from the there are any incubating animals in the communicable diseases and, if found to Risk Class R1 region. Requiring such group of animals intended for export, be affected with a disease agent, would tests would also provide some the exposed susceptible animals should be quarantined either until they additional active surveillance for the develop clinical illness either during the recovered from the disease, were exporting region. pre-embarkation or, when required, destroyed, reexported or were returned Risk Class R2 Regions: There could during the post-importation quarantine. to the region of origin. Animals possibly be residual infection in Risk For this reason we do not believe that imported through land border ports Class R2 regions. Requiring a pre- additional sentinel animals are could be returned directly to the region embarkation quarantine for animals necessary for the importation of animals of origin. At this time, based on the from such regions for importation into from this Risk Class level where sentinel information available to us, there are no the United States would ensure that any animals are generally specified. countries in the world that would imported animals are not incubating the Risk Class R4 and RU Regions: Risk qualify as Risk Class RN for all disease when they are presented for Class R4 or RU regions would be higher restricted disease agents of ruminants or export. As for Risk Class R1 regions, a prevalence regions, or regions that may swine, although individual regions in negative serological test during the have less than adequate control and some countries may be able to meet quarantine period for any animals from surveillance programs. The health status such requirements. 16996 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

At this time, there are many countries disease in question, as well as the M. bovis can affect a wide variety of that may be classified as Risk Class RN animal. As discussed above in this animals, including most species of for certain restricted disease agents. SUPPLEMENTARY INFORMATION under the ruminants, swine and rodents. The Therefore, specific testing and heading ‘‘Proposed Part 92,’’ there are United States has been working since quarantine would not be required for certain restricted diseases that are not 1917 to eradicate this disease agent. At those disease agents, even though specifically mentioned in the current present, there are a few cases of bovine testing or quarantine would be required regulations, because, practically tuberculosis in some States of the for other agents. For example, Canada speaking, animals that may have been United States. and Mexico would both be considered affected with these diseases were Bovine tuberculosis has a long as Risk Class RN for foot-and-mouth prohibited or restricted importation due incubation period, often measured in disease virus and rinderpest virus in to the existence of other diseases in the months or years. Affected animals may ruminants and swine. Canada would country of origin. With the proposed not show any external clinical evidence also be considered as Risk Class RN for establishment of risk class levels for of the disease until the final terminal hog cholera in swine, but because hog regions, however, a region may be of stages, but most will remain carriers for cholera does exist in parts of Mexico, low risk for a disease that is addressed life. There is no cost effective treatment those Mexican regions would be in the current regulations, but of high for bovine tuberculosis, even though required to meet specific test and risk for a disease not specifically treatments with various antibacterial quarantine requirements to import addressed in the current regulation. chemicals are routinely done for swine into the United States. However, Therefore, we believe it is necessary to humans affected with tuberculosis. The we would not have any greater establish distinct restrictions regarding use of similar treatments in animals is requirements for Mexico for foot-and- all disease agents of concern, even those not desirable because of the risk of mouth disease or rinderpest virus than not addressed in the current regulations. developing resistant strains of the we would have for Canada. One broad category of diseases not organism, and the prohibitive cost. The criteria for a Risk Class RN region addressed consistently in the current The only effective method of include the requirement that all importation regulations is that of detecting infected carrier animals is by susceptible animals present in the disease agents that are present in the use of various tests. Intradermal tests region were not living when the region United States, but that are subject to have generally been applied. These tests was last infected. Arriving at an control or eradication programs. The estimate for the specific time interval require injection of tuberculin into the requirements that do exist are specific to skin of the animal, and then observation this requires will vary with the species particular importing countries. For involved. In the case of cattle, although of the reaction at a later time, usually 72 example, current § 92.418 includes hours. Animals generally cannot be the lifespan of a few cattle can exceed testing requirements for tuberculosis 20 years, for practical purposes most retested again for at least 60 days, and brucellosis for cattle from Canada. because the test usually results in cattle in a domestic herd would be Current § 92.419 includes requirements culled before 15 years. In swine, desensitization of the skin at the test for scrapie certification for sheep and site. The skin test is relatively occasionally a sow or boar may live 15 goats from Canada. Current § 92.427 years, but in practice, nearly all sows insensitive and may miss many infected includes requirements for fever ticks, animals. It is generally more sensitive in and boars in domestic farm operations tuberculosis, and brucellosis for cattle are culled before 5 years of age, detecting infected herds when applied from Mexico. Each of these to the entire herd of origin. Quarantine although there may be some marginal requirements is particular to the country farm operations that keep a boar for up beyond the period of time necessary to specified. In this proposal, we are conduct an intradermal test is not to 10 years. In determining the setting forth requirements regarding the birthdates of ruminants and swine in a effective for bovine tuberculosis, except importation of ruminants and swine to prevent the quarantined animals from region for the purpose of classifying the from countries affected with restricted region RN, we would use 15 years as the contacting infected animals. disease agents subject to control or The domestic regulations for bovine estimated life expectancy for cattle and eradication programs in the United 10 years for swine. These time spans tuberculosis are set forth in 9 CFR part States, and we apply these requirements 77. Essentially, the program in the reflect the pragmatic management of according to the Risk Class levels of domestic livestock. Although other United States is based on domestic foreign regions, rather than to ‘‘regionalization,’’ through the susceptible ruminants such as elk, specifically named countries. camels, llamas, or bison may classification of States based on their theoretically be kept longer than the 15 Restricted Diseases That are Present in risk status. Each of the States in the years we are considering as the the United States But Are Subject to United States qualifies as either maximum life span, we do not believe Control or Eradication Programs. Accredited free or Modified accredited, as defined in § 77.1. In order for a State that in these species survival after 15 Mycobacterium Bovis years would occur at a high frequency. to become accredited free, 5 years must Proposed §§ 93.415(b) and 93.515(g) pass without any known infection in the Risk Level Classifications Other Than include requirements for the State. Risk Class RN importation of ruminants and swine, If each State classified under the Except for Risk Class RN, the respectively, from Risk Classes R1 domestic bovine tuberculosis program requirements for the importation of through RU with regard to were a foreign region, the State animals from regions of each risk class Mycobacterium bovis (M. bovis), the classifications would fall into regional level would be dependent on the causative agent of bovine tuberculosis. risk classifications as follows:

Comparable Domestic classification Conditions risk class

``Modified Accredited'' ...... Infected herds in State; more than 0.1% of herds infected. No States in the United R4 States currently in this category. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 16997

Comparable Domestic classification Conditions risk class

``Modified Accredited'' ...... Infected herds in State; fewer than 0.1% of herds infected ...... R3 ``Modified Accredited'' ...... No known infected herds in State for at least 1 year ...... R2 ``Accredited Free'' ...... No known infected herds in State for at least 5 years ...... R1 ``Accredited Free'' ...... No known infected herds in State for at least 15 years ``Accredited Free'' at least 10 RN years.

Currently, there are no States in the classified as Risk Class R2 for M. bovis, interpreted to mean ‘‘Mexican origin,’’ United States that are not at least only non-neutered ruminants or swine but we propose the ‘‘M’’ be used to ‘‘Modified Accredited.’’ If there were would be required to be tested, 60 to 90 indicate high risk for ‘‘Mycobacterium’’ such areas, they would be equivalent to days prior to export, with a retest at the from any origin. proposed Risk Class R4 if testing were port of entry. We believe these tests The proposed requirements for the being done to achieve a ‘‘Modified would be necessary, because these are importation of ruminants and swine Accredited’’ status or as proposed Risk the animals most likely to move into from regions classified as R4 and RU Class RU if such testing were not being established breeding herds in the United regions for M. bovis would be similar to done. States. Because neutered animals those for R3 regions. However, because As indicated above, the risk classes usually remain separate from other the equivalent of accredited herds are we are proposing for foreign regions animals, and are slaughtered soon after not recognized in R4 or RU regions, all with regard to M. bovis are comparable reaching the United States, combined ruminants or swine would be required to the domestic classifications of with the low risk of the source region to originate from a herd that has had a accredited free and modified accredited. and the low risk of transmission once in negative test for bovine tuberculosis 4 to The proposed requirements for the United States, we believe neutered 12 months prior to export. The animals importations from Risk Class R1 regions animals do not need to be tested. to be exported would be required to be would be similar to interstate movement For importation from a region quarantined for at least 60 days prior to requirements in the United States from classified as Risk Class R3 for M. bovis, export to prevent exposure to infection ‘‘Accredited Free’’ States. A certification the ruminants and swine must either to other untested animals before export. of origin would be required for originate from a herd that meets the importation from both Risk Class RN criteria for ‘‘accredited-free’’ as defined Brucella Abortus, B. Suis, and B. and R1 regions to prevent presentation in § 77.1, or the herd of origin must have Melitensis of ruminants or swine from higher risk had a negative test for bovine In § 93.415(c) of this proposal, we set regions as originating from Risk Class tuberculosis 4 to 12 months prior to forth the requirements for the RN or R1 regions. Because of the export to the United States. We believe importation of ruminants imported from prolonged incubation period for bovine the minimum 4-month requirement is Risk Class R1 through Risk Class RU for tuberculosis, this requirement would be necessary to allow at least 60 days Brucella abortus, B. suis biovar 4, and applicable during the lifetime of any before the individual exported animals B. melitensis. The United States ruminant or swine intended for must be retested, because the currently has an eradication program for importation from these regions. If intradermal tests for M. bovis must be at B. abortus, which exists at a low animals that originated in a Risk Class least 60 days apart. prevalence in a few States. Brucella suis R2, R3, R4 or RU region were presented For importation from a Risk Class R3 biovar 4 does not occur in the United for export from Risk Class RN or R1 region, the certificate of export for swine States except in caribou in the State of regions, they would be required to meet must certify that the swine have never Alaska. Brucella melitensis has been the requirements for importation from been on any premises while animals eradicated from the United States. the region of greater risk. affected with M. bovis have been present The proposed requirements for on those premises. Both neutered and The bovine brucellosis eradication importation of ruminants or swine from non-neutered ruminants and swine program in the United States in effect regions classified as R2 and R3 for would need to be tested 60 to 90 days regionalizes the United States according bovine tuberculosis would be similar to before export, and non-neutered animals to the prevalence of brucellosis infected the requirements for interstate would be required to be tested again at herds in the individual States. The movement requirements in the United the port of entry. Because of the regulations regarding brucellosis in the States from modified accredited States. increased risk that neutered animals United States are set forth in 9 CFR part Although the Federal regulations do not from Risk Class R3 regions might be 78. In § 78.1, definitions for the disease require a test for breeding cattle or infected, such animals would need to be risk status of individual States are set swine moving interstate from modified identified with a permanent mark on the forth for Class Free, Class A, Class B, or accredited States, most States do have left hip, consisting of the letter ‘‘M’’ for Class C for bovine brucellosis. such a requirement for cattle and other males and ‘‘Mx’’ for neutered females. It is possible to gauge where each of ruminants entering their State from Traditionally most animals imported these classes would fall if the States to modified accredited States. into the United States that would fit into which they apply were foreign regions In the case of ruminants or swine this class have been from Mexico, so, classified by Risk Class level. The intended for importation from regions currently, such an ‘‘M’’ has been following comparison could be made:

Comparable Domestic classification Conditions risk class

Class Free ...... Class Free for more than 15 years and vaccination not permitted except for export RN Class Free ...... Class Free for more than 4 years and vaccination not permitted except for export R1 Class Free ...... No known infected herds for more than 1 year and/or vaccination permitted R2 16998 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

Comparable Domestic classification Conditions risk class

Class A ...... Less than 0.1% herd incidence rate ...... R3 Class A ...... More than 0.1% herd incidence rate ...... R4 Class B Class C Quarantined area ...... Does not meet minimum standards of eradication program ...... RU

Currently, all States in the United region, they would be subject to the can be made with regard to swine States are either Class Free or Class A. requirements for importation from Risk brucellosis, as follows: If the individual States were in a foreign Class R2 regions. To qualify for importation from a country, all of the Class A States would Swine brucel- Comparable be classified as Risk Class R3, because region classified as either Risk Class R2 losis classifica- Conditions risk class the herd infection rate is less than 0.1% or (if a certified brucellosis-free herd) as tion Risk Class R3, these proposed rules (1 per 1000). Class A status allows for Validated Bru- Validated RN herd infection rates up to 0.25% (2.5 per would require a certification of origin cellosis-Free. Free for 1000) so in theory it would be possible for the ruminants to be imported from more than for a Class A State to be Risk Class R4. either a Class RN, R1, R2, or (if a 10 years. All of the Class Free States in the United certified brucellosis-free herd) R3 No adjacent States would be Risk Class R2 because region, negative results to a brucellosis States risk they all permit, and some even test of the animals to be imported class R3, encourage, calfhood vaccination. Some conducted 30 to 60 days before being R4 or RU. of these States could easily qualify as presented for export, and a retest with Validated Bru- No known in- R1 Risk Class RN or R1 if they were to negative results at the port of entry. The cellosis-Free fected do- prohibit calfhood vaccination except for ruminants may have been vaccinated Stage II. mesticated herds for animals that were to be exported to only with B. abortus Strain 19 in more than 5 other States. accordance with the procedures in 9 years, Vali- Because the only clinical evidence of CFR part 78. dated Free brucellosis in animals is abortion, For non-neutered ruminants from for more inspection of animals is not a reliable herds not certified as brucellosis-free in than 3 indicator of infection. Brucella affects Risk Class R3 regions, or for non- years. only breeding animals, so there is no neutered ruminants from Risk Class R4 Validated Bru- No known in- R2 need to test neutered animals for and Risk Class RU regions, the herd of cellosis-Free fected do- brucellosis. The approved testing origin must have been tested and found Stage III. mestic procedures for brucellosis are very negative for brucellosis within 6 to 12 herds for sensitive, and most infected animals months prior to export of the ruminants. more than 1 year and/or that have had a sufficient incubation If any test-positive animals were found infected period will be positive to the test. The during the test, they must have been feral swine incubation period for brucella infections removed from the herd and all in region. can be quite variable, depending remaining animals must be retested May include primarily on the stage of pregnancy in with negative results not less than 6 some Stage the infected animal. For this reason, months after any test-positive animals II areas under the restrictions for importation were removed. Additionally, individual qualifying from Risk Class R3, R4, and RU regions, ruminants to be imported must have for Stage III. we would not allow animals to be undergone a minimum of 30 days pre- Non-validated Less than R3 imported from infected herds, even if Stage II. 0.1% herd embarkation quarantine prior to export, incidence the individual animals test negative. must have had a negative result to an rate. There is no cost-effective treatment approved test for B. abortus, B. suis Non-validated More than R4 for brucella infections in animals. Since biovar 4, and/or B. melitensis within the Stage I. 0.1% herd most animals will show some 30 days prior to export, must be incidence serological signs of brucellosis after 30 quarantined for at least 15 days at a rate. days, quarantines of 30 to 60 days are post-importation quarantine designated Non-validated Does not RU an effective method of preventing and approved by the Administrator, and meet mini- introduction of exposed animals. must have a negative result to approved mum stand- To qualify for importation from a tests for B. abortus, B. suis biovar 4, ards of region classified as either Risk Class RN and/or B. melitensis during the post- eradication program. or R1 for brucellosis, non-neutered importation quarantine period. ruminants over 6 months of age would need to be accompanied to the United Brucella Suis Currently all States in the United States with a certification of origin and Proposed § 93.515(b) specifies States are either validated brucellosis- certification that the ruminants were not requirements for swine intended for free or, if non-validated, have less than vaccinated with any live brucella export from regions classified from Risk 0.1% herd incidence rates. If the States vaccine. However, if ruminants to be Class R1 through RU for Brucella suis. in this country were foreign regions, all imported originate from a Risk Class R1 Just as comparisons can be made of the validated brucellosis-free States region and had been vaccinated with between domestic State Risk Class would be Risk Class RN, R1, or R2, and Brucella abortus Strain 19 vaccine status and foreign Risk Class status for the non-validated States would be Risk before the region became a Risk Class R1 bovine brucellosis, similar comparisons Class R3. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 16999

Vaccination is not permitted or imported are removed from the herd. If parturition. Any seropositive animal recommended in swine herds. Some any swine were found to be positive on should be considered a potential virus States have known infection in feral a herd test, the herd would need to have carrier. Carrier swine would not be swine located in the State. These States, undergone a herd cleanup plan expected to have any clinical signs of if foreign regions, would fall into the equivalent to the plan required in 9 CFR the infection. Risk Class R2 classification, provided part 78. The complete herd test, and Current tests for PRV are very there has been no transmission of B. suis clean-up of each infected herd, would sensitive, and infected swine will be to domesticated swine herds within the essentially qualify the herd as a expected to have detectable antibody as previous year. States in which validated brucellosis-free herd. early as 6–7 days after exposure, with transmission to domestic swine herds Therefore, individual swine peak antibody titers about 5 weeks after has occurred would, if foreign regions, subsequently intended for importation exposure. Antibodies in recovered or be Risk Class R3. from R3 regions would be subject to the carrier swine may persist for years. Under proposed § 93.515(b) regarding same requirements as swine from R3 Vaccinated swine may be protected B. suis, swine from any regions regions intended for importation from from clinical disease, but the virulent classified as Risk Class R1 or R2 for the validated brucellosis-free herds. virus may still replicate and become disease, or from an R3 region if from a No swine from any risk category established in a carrier state. validated brucellosis-free herd, would would be eligible for importation if they Pseudorabies virus is relatively stable be allowed to move for slaughter to any have been vaccinated with a live at mild acidic or alkaline conditions, approved slaughter plant in the United Brucella vaccine. Vaccination of swine although strong acids and strong alkalis States, provided they move in vehicles for brucellosis has not been found to be readily kill the virus. The virus can closed with official seals of the United efficacious in the United States. Some survive for long periods in the States government applied and removed areas of the world use a live attenuated environment if the pH and humidity by an APHIS representative, or an B. suis biovar 2 vaccine. Brucella suis remain within an optimal range of ph 6– individual authorized for this purpose biovar 2 is not known to exist in the 8, and the temperature remains between by an APHIS representative. United States, so this vaccine, even ¥8° C to 25° C. The virus generally dies For swine to be otherwise imported though attenuated, would be considered out rapidly when frozen at ¥13° C to from regions classified as Risk Class R1, an exotic disease agent in the United ¥20° C. However, although freezing in these proposed rules would require that States. most cases rapidly kills the virus, it can the swine be accompanied by a be preserved for years frozen at ¥90° C. Pseudorabies certification that they originated in a Direct sunlight rapidly destroys the Risk Class RN or R1 region, and that the In this proposed rule, § 93.515(c) sets virus. Although the virus can survive for animals were not vaccinated with any forth import requirements for swine relatively long periods of time in meat, live brucella vaccine. intended for importation from regions usually little virus is found in the For swine to be imported from regions classified from Risk Class R1 through muscle of naturally infected swine. The classified as Risk Class R2, or for swine RU for pseudorabies virus (PRV). virus exists primarily in the lymphoid from validated brucellosis-free herds in Pseudorabies affects all classes of swine and nerve tissue. There are no known Risk Class R3 regions, a certification of and can occasionally affect other treatment procedures that will clear origin in a Risk Class RN, R1, or R2 animals, such as sheep or cattle, which infected carrier swine of the infection. region, or from a validated brucellosis- are dead-end hosts. The primary Currently, a cooperative Federal/State free herd would be required, along with reservoir is in swine. On breeding swine eradication program for PRV is a negative test of the imported animals farms, reproductive disorders and conducted in all States of the United for B. suis 30 to 60 days before being nervous disorders in baby pigs are the States. The PRV eradication program in presented for export. A negative retest at most frequently seen clinical signs of the United States in effect regionalizes the port of entry would also be required. PRV. The incubation period of PRV in the country by State, according to the For the importation of non-neutered susceptible swine is usually variable, prevalence of PRV infected herds and swine over 6 months of age from herds ranging from 36 to 48 hours in newborn the progress in the eradication program not validated brucellosis-free in Risk pigs, and 3 to 5 days in older swine. in each State. The State classifications Class R3 regions, and for non-neutered Most infected swine excrete virus are Stage I (Preparation), Stage II swine over 6 months of age from Risk only for 14 to 28 days following (Control), Stage III (Mandatory herd Class R4 or RU regions, all swine over infection, but some do become cleanup), Stage IV (Surveillance), and 6 months of age in the herd of origin persistent carriers of the virus for long Stage V (Free). If the States of the United would need to have had negative results periods of time. Recrudescence with States were foreign regions, they would to a test for B. suis within 6 months virus excretion can occur following be classified according to Risk Class as prior to the date the swine to be stress or other stimuli, such as follows:

Comparable Pseudorabies classification Conditions risk class

Stage V (Free) ...... Stage V for more than 10 years and vaccination not permitted except for export ...... RN Stage V (Free) ...... Stage V (Free) for more than 3 years and vaccination not permitted except for export R1 Stage V (Free) ...... Stage V (Free) after 2 years. No known infected herds for more than 2 years ...... R2 Stage IV (Surveillance) ...... Stage IV (Surveillance) for at least 1 year. No known infected herds for at least 1 R2 year. Vaccination permitted. Stage IV (Surveillance) ...... Stage IV for less than 1 year ...... R3 Stage III ...... Less than 0.1% herd incidence rate ...... Stage III ...... More than 0.1% herd incidence rate ...... R4 Stage II Stage I ...... Does not meet minimum standards of eradication program ...... RU 17000 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

Currently all States in the United Scrapie and found free of evidence of scrapie, States are in stages II through V of the and of any other communicable disease; In this proposed rule, § 93.415(h) sets PRV program. Under proposed (2) That, as far as it has been possible forth requirements for sheep and goats § 93.515(c), swine from any region with to determine, such animals have not imported from regions classified as Risk regard to pseudorabies would be been exposed to any such disease Class R1 through Risk Class RU for allowed movement to slaughter under during the preceding 60 days; scrapie. Scrapie disease of sheep and the same conditions as those described (3) That, as far as can be determined, goats exists in the United States at a low above for direct movement to slaughter scrapie has not existed on any premises prevalence. The United States has with regard to B. suis. There is no on which such sheep or goats were attempted to eradicate scrapie disease known evidence that PRV is transmitted located during the 42 months since the 1950’s, when it was first to swine from meat or infected meat immediately prior to shipment to the imported in sheep. The nature of the scraps fed in garbage. United States; causative agent for scrapie is somewhat Under this proposal, to be imported controversial, as it is not a true virus, (4) That each of such animals is not from a Risk Class R1 region, swine although there are many attributes of the the progeny of a sire or dam that has would need to be accompanied only infection that resemble a virus infection. been affected with scrapie; and with certification that the swine Sheep and goats are usually infected at (5) That, as far as it has been possible originated in a Risk Class RN or R1 a young age, but the disease does not to determine, each of such animals is region, and that the animals were not appear until several years later as an not a sheep or goat that would have vaccinated with any PRV vaccine. encephalopathy. The incubation period been slaughtered under the current To be imported from either a Risk for scrapie can last up to 5 years. Canadian scrapie eradication program Class R2 region or from a qualified Currently, the only certain method of had that program been in effect since pseudorabies-negative (QPN) herd in a diagnosing scrapie is by microscopic April 1957. Risk Class R3 region, swine would need examination of the brain tissue of Sheep and goats would be prohibited to be accompanied by certification that infected animals. Reliable serologic tests importation from regions classified as they originated in a Risk Class RN, R1 are generally not available. The only Risk Class R4 and RU for scrapie, or R2 region, or in an R3 region if from practical method of certifying sheep or because we believe that the a qualified pseudorabies-negative herd goats for movement is by flock or herd requirements for Risk Class R3 regions that has been qualified according to history of the flock of origin, or regional are necessary to guard against the procedures equivalent to those set forth history of scrapie. importation of scrapie-affected animals, in part 85 of this chapter, and by and we do not believe that the Only a few countries of the world are certification that the swine tested certifications of Risk Class R3 regions considered to be free of scrapie. Others negative for PRV within 30 days before can be made in Risk Class R4 or RU have eradication programs similar to the being presented for export. The purpose regions. of the test is to prevent importation of United States, but are low prevalence any residual infection that may occur in infected areas. According to the risk Contagious Diseases Exotic to the the region. We believe the testing is class criteria proposed in § 92.2 of this United States necessary to detect animals that may be proposal, the United States, if a foreign In this proposal, § 93.415(d) sets forth vaccinated but not recorded as region, would be classified as a Risk requirements for ruminants imported vaccinated animals. Class R3 region. from regions classified as Risk Class R1 For swine to be imported from herds Under this proposal, for sheep and through RU for foot-and-mouth disease not QPN in Risk Class R3 regions, and goats to be imported from regions (FMD) virus in ruminants, and from Risk Class R4 and Risk Class RU classified as risk class RN, R1 or R2 for § 93.515(e) sets forth requirements for regions, the swine intended for export scrapie, the sheep and goats would need swine moving from regions classified as must have had a negative test within 30 to be accompanied by certification that Risk Class R1 through RU for FMD, days prior to export and must have been they have been only in one of those rinderpest (RP), African swine fever quarantined separate from all swine not regions during their entire life, and have (ASF), hog cholera (HC), and swine in the shipment, for 30 days prior to only been on premises where no cases vesicular disease (SVD). The export. The imported swine would be of scrapie have been diagnosed during requirements governing these diseases subjected to a post-importation the 5 years immediately preceding the are set forth in the same paragraph of quarantine for at least 15 days, during date of intended exportation. this proposal, because the importation which time they must have a negative The requirements for the importation requirements for each of the diseases are test for PRV. Certain vaccines are of sheep and goats from regions similar for each of the risk classes. permitted in the United States under classified as risk class R3 for scrapie These diseases are grouped also because part 85 of this chapter. Because tests are would be similar to the current scrapie the epidemiology is similar and all of available that will distinguish between importation requirements for sheep and these diseases can be transmitted to new the vaccine strains and virulent PRV, goats from Canada, set forth in § 92.419 animals in meat and other animal the vaccinated swine should create no of the current regulations. The proposed products. problem in the testing procedure. We regulation equivalent to requirement The incubation periods for FMD, RP, believe the 30 day pre-embarkation ‘‘(5)’’ below, regarding the Canadian ASF, HC, and SVD are all relatively quarantine would be adequate to detect scrapie eradication program, would be short, and all of these diseases are any swine that were incubating PRV the requirement that the region in highly contagious, with spread by infection when they entered the farm. question conduct a scrapie eradication contact, aerosol, and feed or water being The additional 15 days post-importation program equivalent to that conducted in the most common methods of spread. quarantine would be to assure that there the United States. The provisions in Vector transmission of ASF by was no transmission from possible current § 92.419 require a certificate Ornithodoros ticks has been shown to silent carrier swine or from stating: occur and mechanical vector environmental contamination while in (1) That the sheep and goats have transmission of HC has also been pre-embarkation quarantine. been inspected on the premises of origin demonstrated. Mechanical transmission Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17001 of each of these disease agents by ticks effective treatments for any of these and swine would need to test negative and insects is possible. viruses, and any recovered animals to an approved serological test for FMD, would be likely to be carriers. Therefore, RP, ASF, HC, and/or SVD. Foot-and-Mouth Disease if there is evidence of infection in a For ruminants and swine to be Foot-and-mouth disease affects all quarantine facility, none of the exposed imported from regions classified as Risk members of the family artiodactyla, as animals would be allowed to enter the Class R3 for FMD, and for swine to be well as some rodents such as the United States. imported from regions classified as Risk hedgehog. Cattle are readily infected Class R3 for RP, ASF, HC, or SVD, the and may be carriers of the virus for long FMD Requirements for Ruminants and animals would need to be accompanied periods of time through localization of Swine, and RP, ASF, HC, and SVD by certification that they (1) were born the virus in the pharyngeal lymphoid Requirements for Swine and resided only in regions listed as (tonsil) tissue. Vaccinated cattle may Under this proposal, we would Risk Class RN, R1, R2, or R3 for FMD; become infected and either not show prohibit the importation of any (2) have not been on any premises any clinical signs or have a mild ruminants and swine that have been affected with FMD virus during the 12 atypical disease. Carrier cattle do not vaccinated for FMD, RP, ASF, HC, or months prior to export; (3) have not readily transmit the virus to other SVD. Ruminants and swine to be been on any premises located within 25 animals, but are a constant threat to do imported from regions classified as R1 miles (40 km) of any premises affected so. Swine produce and disseminate for FMD, RP, ASF, HC, or SVD would with FMD virus in the 90 days prior to large quantities of virus when infected, be required to be accompanied by a export; (4) have undergone pre- but do not remain carriers for long certification that the ruminants or swine embarkation quarantine for at least 60 periods of time. Foot-and-mouth disease were born and resided only in regions days prior to export, under USDA virus is relatively resistant outside the classified as Risk Class RN or R1 for the supervision in a facility approved by the host animal, provided the pH remains disease in question, and have had a Administrator; and (5) have had, during near neutral. Acidic or alkaline negative test for the disease in question the pre-embarkation quarantine, conditions readily kill the virus. within 30 days prior to the date of negative results to two tests conducted export. for FMD, using an approved serological African Swine Fever, Hog Cholera, and The only ruminants and swine from Swine Vesicular Disease test. If indicated, oesophageal- R1 regions excepted from the testing pharyngeal fluid samples would be Only swine are affected with ASF, HC requirements, and also from the taken for further testing. Additionally, and SVD viruses. These viruses are quarantine requirements for R2 regions the ruminants and swine would have to primarily transmitted directly between discussed below, would be ruminants be quarantined for at least 60 days swine, but ASF particularly can be and swine imported for immediate without sentinel animals at the Harry S transmitted by Ornithodoros ticks. slaughter that were born and raised in Truman Animal Import Center, during Infected swine that recover may remain regions classified as Risk Class R1 or R2 which time they would be tested for the carriers of these agents for long periods for the diseases in question. Such disease in question at least once. of time. The viruses of ASF and SVD are animals would be required to be The requirements for ruminants and quite resistent to heat, putrefaction, and consigned from the port of entry to a swine to be imported from regions acidic and alkaline conditions. Wild recognized slaughtering establishment, classified as R4 or RU for FMD, and for swine such as the wart hog, bush pig and there slaughtered within 2 weeks of swine to be imported from regions and giant forest pig in Africa are the the date of entry. The ruminants would classified as R4 or RU for RP, ASF, HC, primary reservoir of ASF. Infected pork need to be moved from the port of entry or SVD, would be the same as those for and pork products can readily carry HC, in conveyances closed with official seals ruminants and swine imported from R3 ASF and SVD. Sheep and calves can be of the United States government applied regions, except for the certification of infected with SVD but do not develop and removed by an APHIS residency, and except that ruminants a clinical illness and are not likely to representative, or by an individual and swine from R4 regions would need spread the virus unless meat from authorized for this purpose by an APHIS to be quarantined at HSTAIC for at least affected animals is fed to swine. Only representative. 90 days with sentinel animals from the swine are susceptible to HC virus, in For ruminants and swine to be United States. which acute, subacute and chronic imported from regions classified as Risk disease occurs. Congenital infection of Class R2 for FMD, and for swine to be Rinderpest and Peste de Petits pigs helps maintain the disease in a imported from regions classified as Risk Ruminants herd, but movement of carrier swine or Class R2 for RP, ASF, HC, or SVD, the In § 93.415(e) of this proposal, we set feeding of meat scraps to swine is the animals would need to be accompanied forth requirements for ruminants to be primary method of transmission by a certificate that certifies that they imported from regions classified as Risk between herds. Acidic and alkaline were born and resided only in regions Class R1 through RU for rinderpest and conditions readily destroy HC virus but classified as Risk Class RN, R1, or R2 for peste de petits ruminants (PPR). the virus is very stable in refrigerated the diseases in question. The ruminants Rinderpest virus primarily affects cattle and frozen meat. and swine would also be required to and buffalo but a wide variety of cloven Viral infections with FMD, ASF, HC, meet the testing requirements required hoofed animals are susceptible. and SVD are readily detected with for animals from R1 regions, and, European swine do become infected, but modern serological tests. Testing the additionally, would need to undergo a the disease is primarily inapparent. The herd of origin as well as any exported 30-day pre-embarkation quarantine (for incubation period ranges from 3 to 15 pigs from areas known to be affected swine from regions classified as Risk days, and affected animals have a high will significantly reduce the risk of Class R2 for ASF, the pre-embarkation mortality rate. Recovered animals do not introducing any of these viruses. quarantine must be conducted in a remain carriers. Subacute infections Quarantines are necessary to detect any vector-proof facility approved by the may occur in regions where the disease animals that may be incubating the Administrator), and a 15-day post- is endemic or in breeds of animals or virus or be inapparent carriers upon importation quarantine. During the post- species that have an innate resistance. entry into the quarantine. There are no importation quarantine, the ruminants Rinderpest virus is not very stable 17002 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules outside the host, and is readily Although BSE is not known to affect CA, SP, GP, or CCPP, sheep and goats destroyed by acidic or alkaline humans, the fear of the disease would need to be accompanied by conditions, and by direct sunlight. The generated in the United Kingdom has certification that they were born and virus of PPR is closely related to caused severe economic hardship to the resided only in regions classified as Risk rinderpest virus but primarily affects cattle industry in the British Isles. Class RN or R1, and that they have had sheep and goats. Because of the long incubation period a negative test for the disease in Viral infections with rinderpest and and the lack of a suitable diagnostic test, question within 30 days prior to export. PPR are readily detected with modern the only way of preventing introduction Sheep and goats to be imported from serological tests. Testing the herd of of the disease is by certification of herd regions classified as Risk Class R2 for origin, as well as any exported animals and regional history of the disease, CA, SP, GP, or CCPP would be required from areas known to be affected, will along with the presence of a strong to be accompanied by certification that significantly reduce the risk of regional animal health infrastructure they were born and resided only in introducing any of these viruses. capable of recognizing and diagnosing regions classified as Risk Class RN, R1, Quarantines are necessary to detect any the disease if it should occur. or R2, and that they have had a negative animals that may be incubating the Under this proposal, cattle imported result to an approved serological test for virus or be inapparent carriers upon from regions classified as Risk Class R1 the disease in question 30 to 60 days entry into the quarantine. There are no or R2 for BSE would need to be prior to exportation to the United States. known effective treatments for these accompanied by certification that the Additionally, the sheep and goats would viruses. Although any recovered cattle were born and resided only in R1 have to be quarantined for at least 15 animals do not remain as carriers, as a or R2 regions, and that the cattle have days at a post-importation quarantine matter of precaution, animals with a only been on premises where no cases facility designated and approved by the known history of infection or exposure, of BSE have been diagnosed during the Administrator, and would have to test including those exposed to infection in 10 years immediately preceding the date negative to an approved serological test a quarantine center, should be of exportation. for the disease in question during the prohibited entry into the United States. Cattle from regions classified as Risk post-importation quarantine. As with rinderpest, any animal Class R3, R4, or RU for BSE would be In addition to residency certification, vaccinated for PPR would be prohibited prohibited importation into the United sheep and goats to be imported from importation into the United States. States. regions classified as Risk Class R3 for Ruminants intended for importation CA, SP, GP, or CCPP would have to Contagious Agalactia due to from regions classified as R1 or R2 for meet one of the following requirements: Mycoplasma agalactia, Sheep Pox RP and PPR would be required to meet Either (1) test negative to an approved Virus, Goat Pox Virus, and Contagious the same requirements as ruminants serological test for the disease in Caprine Pleuropneumonia due to from regions classified as R1 and R2 for question 30–60 days prior to exportation Mycoplasma Mycoides Subsp. Capri FMD. The requirements for ruminants to the United States; or (2) originate from R3 regions for RP and PPR would Section 93.415(i) of this proposal sets from a herd or flock in which all sheep be the same as for R3 for FMD, except forth requirements for sheep and goats and goats over 6 months of age have had that, in the case of RP and PPR, the intended for importation from regions a negative result to an approved ruminants would be required to undergo classified as R1 through RU for serological test within 12 months prior pre-embarkation quarantine for at least Contagious agalactia due to Mycoplasma to the time of export. Additionally, the 30 days, would have to test negative to agalactiae (CA), Sheep pox (SP), goat sheep and goats would have to be two tests conducted not less than 15 pox (GP), and contagious caprine quarantined and isolated for at least 30 days apart (if indicated, nasal swabs or pleuropneumonia (CCPP due to days prior to export from all animals not other tissues or samples would be taken Mycoplasma mycoides subsp. capri). part of the shipment, in facilities for further testing), and would be These diseases are grouped together approved by the Administrator. The required to be quarantined at HSTAIC because they affect only sheep and goats sheep and goats would also have to for at least 30 days without sentinel and the epidemiology is similar. Both undergo at least a 15-day post- animals. The requirements for CA and CCPP are chronic diseases with importation quarantine, and have a ruminants from regions classified as R4 long incubation periods. Antibodies negative result to an approved or RU for RP and PPR would be the generally are found in infected animals serological test during that quarantine. same as those for R3 regions, except long before the appearance of clinical To be imported from regions that, for animals from R4 regions, the signs. Both SP and GP are acute viral classified as R4 or RU for CA, SP, GP, quarantine at HSTAIC would have to be diseases in which the virus can remain or CCP, sheep and goats would have to conducted with sentinel animals. in the recovered host or host materials be certified as having undergone at least for long periods after recovery. a 60-day pre-embarkation quarantine, Bovine Spongiform Encephalopathy Serological tests for these disease agents and as testing negative to two approved Section 93.415(g) of this proposal are adequate to detect either recovered tests for the disease in question, at least specifies requirements for the carriers in the case of SP or GP, or 30 days apart, with the second test importation of cattle from regions prodromal carriers in the case of CA or during the pre-embarkation period and classified as Risk Class R1 through RU CCPP. Although each of these diseases not more than 30 days before export. for bovine spongiform encephalopathy could probably be easily eradicated if Additionally, the sheep and goats would (BSE). BSE is a scrapie-like disease of detected in the United States, they have to be quarantined for at least 30 cattle that has appeared in the past could become widespread before they days post-importation, and be tested decade in Europe, particularly in were detected and therefore would be negative there to an approved Britain. It is thought to have been costly to eradicate. serological test for the disease in introduced into cattle from scrapie- All sheep or goats that have been question. infected sheep brains that were vaccinated for CA, SP, GP, or CCPP included in rendered protein meal would be prohibited importation into Malignant Catarrhal Fever added to cattle feed. The disease has an the United States. To be imported from In this proposal, § 93.415(j) sets forth incubation period of from 5 to 7 years. regions classified as Risk Class R1 for requirements for the importation of Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17003 ruminants from regions classified as accompanied by certification that they bovine pleuropneumonia (CBPP) in Risk Class R1 through RU for malignant were born and resided only in regions cattle due to Mycoplasma mycoides catarrhal fever—African or Wildebeest classified as Risk Class RN, R1, or R2 for subsp. mycoides. This disease was Type (MCF–A). This disease is MCF–A, and have had a negative result eradicated from the United States in the transmitted from infected wildebeest to an approved serological test for MCF 19th century. The disease has a long and other wild reservoirs in Africa to 30–60 days prior to the date of export. incubation, and infected cattle may not cattle. There is little evidence of The ruminants would also be required demonstrate clinical signs until the late transmission from cattle to cattle. The to be quarantined for at least 15 days at stages of infection. Serologic tests have causative agent for this disease has been a post-importation quarantine facility sufficient sensitivity to detect identified as a herpesvirus. The designated and approved by the incubating animals long before any causative agent for the sheep-associated Administrator, and would need to have other clinical evidence is apparent. Any type of malignant catarrhal fever (MCF– a negative result to an approved serologically positive animal would be S) has not been positively identified, serological test for MCF–A during the excluded from import. although several candidate viruses have post-importation period. Any ruminant vaccinated for CBPP been recovered. MCF–S is transmitted Ruminants intended for importation would be prohibited importation into from sheep to cattle and is found world- from regions classified as Risk Class R3 the United States. Cattle intended for wide, including in the United States. for MCF–A would be required to be importation from regions classified as Therefore, it would not be considered a accompanied by certification that they Risk Class R1 for CBPP would be restricted type of the disease agent in were born and resided only in regions required to be accompanied by this proposed rule. classified as Risk Class RN, R1, R2, or certification that the cattle were born (Although we refer simply to ‘‘MCF’’ R3 for MCF–A, that they have been in and resided only in regions classified as when discussing malignant catarrhal a pre-embarkation quarantine facility, Risk Class RN or R1 for CBPP, that they fever in § 93.415(j) of the proposed rule, approved by the Administrator, for a have undergone a minimum 30-day pre- because the MCF–A type would be the minimum of 30 days prior to export, embarkation quarantine, and that they only type considered a restricted disease and that they either (1) have had a have had a negative result to an agent, in this Supplementary negative result to an approved approved serological test for CBPP Information we specify ‘‘MCF–A’’ when serological test for MCF–A 30 to 60 days within 30 days prior to export. referring to the African or wildebeest prior to the date of export, or (2) Cattle intended for importation from type, to differentiate it from the MCF– originate from a herd in which all regions classified as Risk Class R2 for S type.) ruminants in the herd over 6 months of CBPP would be required to be The principal concern with the age have had a negative result to an accompanied by certification that they importation of MCF–A would be the approved test for MCF–A within the were born and resided only in regions importation of infected wildebeest or previous 12 months. Additionally, the classified as Risk Class RN, R1, or R2 for other African wildlife that may carry the ruminants would need to be CBPP and that they have had a negative virus, rather than introduction in quarantined for at least 15 days at a result to an approved serological test for domestic livestock. However, although post-importation facility designated and CBPP 30 to 60 days prior to the date of the research done indicates that MCF– approved by the Administrator, and export. The cattle would also be A is not transmitted from cattle to cattle, would need to have a negative result to required to be quarantined for at least 15 we believe there is sufficient doubt to an approved serological test for MCF–A days at a post-importation quarantine warrant requiring that any ruminant at during the post-importation quarantine facility designated and approved by the least test serologically negative before period. Administrator, and would need to test importation. MCF–A virus has been Ruminants intended for importation negative to an approved serological test isolated from antelope and deer in two from regions classified as R4 or RU for for CBPP during the post-importation zoos and a wild animal park in the MCF–A would be required to be quarantine period. United States. Serologic tests for MCF– accompanied by certification that they The requirements for importation A are sufficiently sensitive to detect originate from herds that have not been from regions classified as Risk Class R3 possible carrier animals from affected affected with MCF–A during the for CBPP would be similar to those for regions. Because, as with most previous 12 months, that they have importation from regions classified as herpesvirus infections, an infected undergone a minimum of 60 days pre- Risk Class R3 for MCF–A, discussed animal probably remains infected for embarkation quarantine, and that, above. life, any animal with a serologic titer during the pre-embarkation quarantine, The requirements for importation should be excluded from importation. they have had negative results to two from regions classified as Risk Class R4 Any ruminant that has been tests conducted not less than 15 days and RU for CBPP would be similar to vaccinated for MCF–A would be apart with an approved serological test those for importation from regions prohibited importation into the United for MCF–A. Additionally, the ruminants classified as Risk Class R4 or RU for States. Ruminants intended for would be required to undergo post- MCF–A, discussed above, except that importation from regions classified as importation quarantine for at least 15 the interval between pre-embarkation Risk Class R1 for MCF–A would be days at a facility designated and negative tests would have to be at least required to be accompanied by approved by the Administrator, and 30 days for CBPP, as compared to 15 certification that they were born and would need to test negative to an days for MCF–A, and the post- resided only in regions classified as Risk approved serological test for MCF–A importation quarantine for CBPP would Class RN or R1 for MCF–A, and that during the post-importation quarantine be at least 30 days for CBPP, rather than they have had a negative result to an period. 15 days as for MCF–A. approved serological test for MCF–A within 30 days prior to the date of Contagious Bovine Pleuropneumonia Teschen Disease Virus export. In this proposal, § 93.415(k) sets forth In this proposal, § 93.515(h) sets forth Ruminants intended for importation requirements for the importation of requirements for the importation of from regions classified as Risk Class R2 ruminants from regions classified as swine from regions classifies as Risk for MCF–A would be required to be Risk Class R1 through RU for contagious Class R1 through RU for Teschen 17004 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules disease (TDV, also known as from herds in which the entire herd For ruminants and swine to be polioencephalomyelitis). TDV causes an over 6 months of age has had a negative imported from regions classified as Risk encephalomyelitis in swine, due to an result to an approved test for Teschen Class R3, R4 and RU for ectoparasites, enterovirus similar to poliovirus in disease within 60 to 180 days prior to the animals offered for export would be humans. Teschen disease virus is due to the date of exportation; that the swine required to be treated 10 to 14 days porcine enterovirus type 1. Other were quarantined for at least 60 days before export, and to be inspected prior porcine enterovirus types are found prior to export, and that during the pre- to export to be certain they have been throughout the world, including in the embarkation quarantine period, the cleared of any ectoparasites. Except for United States. Except for TDV, the swine have had negative results to an animals imported for immediate porcine enteroviruses generally produce approved test for TDV 30 to 60 days slaughter, ruminants and swine would a mild inapparent infection in swine. prior to the date of export. Additionally, also have to be inspected at the port of Enteroviruses are very resistent to the swine would be required to be entry and retreated for ectoparasites. If inactivation and may remain in the quarantined at a post-importation animals are found to be infested with environment for long periods. quarantine facility for at least 30 days, ectoparasites at the port of entry, they Recovered swine usually do not shed and, during this quarantine period, have would be returned to the country of the virus for long periods after two negative results, not less than 30 origin after treatment if offered for entry appearance of antibody. Animals with days apart, to an approved test for at a land border port, or would be stabilized or declining antibody levels Teschen disease. quarantined for at least 15 days if at would not be expected to be carriers, other ports. but generally any animal with antibody Ectoparasites The purpose of port of entry to TDV antigen would be avoided if In this proposal, §§ 93.415(f) and inspection is to discover any from a TDV-affected region. Cross 93.515(d) set forth requirements for ectoparasites that may have survived the reactions with other enterovirus types ruminants and swine intended for previous treatment in the region of may produce some confusion if swine importation from regions classified as origin. Any ectoparasites found would from areas not affected with TDV are Risk Class R1 through RU for restricted indicate that the animals had not been tested. ectoparasites. Based on the information adequately treated or had become Any swine that has been vaccinated currently available to us, every region of reinfected after treatment in the region with any live TDV is prohibited the world except Canada has one or of origin. At least 10 days must pass importation into the United States. more restricted ectoparasites. Therefore, after treatment to allow the treatment to Swine intended for importation from except for Canada, there are currently have full effect because some treatments regions classified as Risk Class R1 or R2 no regions that would qualify as Risk do not immediately kill the for TDV would be required to be class RN, R1 or R2. Although such ectoparasites. accompanied by certification that the regions may exist, at the present time swine were born and resided only in Vector-Borne Diseases That Are Exotic we do not have information that would to the United States regions classified as Risk Class RN, R1, allow us to make such classifications. or R2 for TDV, and that the swine have Control of ectoparasites is important, Aino and Akabane Virus had a negative result to an approved test not only because of the damage that can for Teschen disease within 30 days of In this proposal, § 93.415(l) sets forth be done by the ectoparasite itself, but the date of exportation. requirements for ruminants offered for Swine intended for importation from also because certain restricted diseases importation from regions classified as regions classified as Risk Class R3 for are known to be transmitted or carried Risk Class R1 through RU for Aino and TDV would be required to be only by certain ectoparasites. By Akabane virus. The incubation periods accompanied by certification that the preventing or intercepting the for Aino and Akabane virus are short, swine were born and resided only in ectoparasite, we effectively prevent and mature ruminants do not remain regions classified as Risk Class RN, R1, transmission of the restricted agent, carriers of the virus for more than 7 to R2, or R3 for TDV, that the swine meet even if it were to be brought into the 14 days, or for 4 to 6 days after one of the following requirements: United States in infected animals. An appearance of antibody. Both these Either (1) they have had a negative example of this situations is bovine viruses cause fetal deformities, and the result to an approved test for TDV 30 to piroplasmosis due to Babesia bigemina, carrier status of affected fetuses is more 60 days before exportation; or (2) they which is transmitted solely by the ticks uncertain. Serologically positive originate from herds in which the entire Boophilus annulatus or B. microplus. pregnant cattle would not be imported. herd over 6 months of age has had This disease has been eliminated from After a 30-day period with no evidence negative results to an approved test for the United States by eliminating the of increasing serological titer, even TDV within 12 months prior to the date tick, rather than addressing the infection serologically positive animals are of of exportation. Unless swine meet the status of the animals. negligible risk for introducing infection. latter of the above two options, they Under this proposal, for ruminants The disease is seasonal and, even from would also be required to be and swine to be imported from regions high risk regions, there is no need to quarantined for at least 30 days prior to classified as Risk Class R1 or R2 regions have insect-secure quarantine facilities export. Additionally, the swine would for ectoparasites, the animals would be during times of the year when insect be required to be quarantined for at least required to be inspected for restricted vectors are not active. During seasons 15 days at a post-importation quarantine ectoparasites at the port of entry. If when insect vectors are active or from station approved by the Administrator, restricted ectoparasites are found, the areas where insect vectors are always and would need to test negative to an animals may not enter until they have active, insect-secure quarantine approved serological test for TDV been treated again in 10 to 14 days. This facilities would be required to be during that quarantine period. time period is necessary because the provided to prevent infection of the Swine intended for importation from treatment will not kill the eggs of the animals to be exported during the pre- regions classified as R4 and RU for TDV parasites, and if any eggs have hatched embarkation quarantine period. Non- would be required to be accompanied they must be destroyed by a second pregnant animals with stabilized or by certification that the swine originate dipping. declining serological titers are a Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17005 negligible risk source of infection in the test results to an approved serological first killing frost in the fall of the year, United States. test for aino and/or akabane virus. would be required to be accompanied by certification that they were Any ruminant that has been Bluetongue, Epizootic Hemorrhagic quarantined and isolated from all vaccinated for aino or akabane virus Disease, Bovine Ephemeral Fever, Rift animals not part of the shipment for at would be prohibited importation into Valley Fever, and Wesselbron the United States. Ruminants offered for least 60 days prior to embarkation in a importation from regions classified as In this proposal, § 93.415(m) sets forth vector-proof facility approved by the Risk Class R1 or R2 for aino or akabane importation requirements for ruminants Administrator. If the ruminants are virus would be required to be from regions classified as Risk Class R1 offered for export during a season of the accompanied by certification that, for at through RU for Bluetongue virus (BTV), year when insect vectors are not active, least 60 days preceding importation, the other than serotypes 10, 11, 13, and 17 the certification must state that the ruminants have been only on premises which are already endemic in parts of ruminants have remained on premises in regions classified as Risk Class RN, the United States; Epizootic in areas where the first killing frost in R1, or R2. The certification would also hemorrhagic disease virus (EHDV), the fall occurred at least 60 days prior need to state that the ruminants have except serotypes 1 and 2 which are to the date of embarkation. had a negative result to an approved already endemic in parts of the United In either case, the certification would serological test for aino and/or akabane States; bovine ephemeral fever (BEF, also need to state that the ruminants virus within 30 days prior to the date of also known as Kotankan or Obodhiang) have had negative results to an virus; Rift valley fever (RVF) virus, and export. If, upon being tested, any of the approved serological test 30 to 60 days Wesselsbron (WB) virus. ruminants in the shipment had a prior to the embarkation. If any of the There are at least 20 serotypes of BTV ruminants tested positive to this test, for positive result to the test, for any of the and 6 serotypes of EHDV that have been remaining ruminants to be imported, all the remaining ruminants to be imported, identified in the world that are not the positive animals would need to be positive pregnant female ruminants known to be present in the United would need to be removed from the removed from the shipment, and the States. Each of these could possibly remaining ruminants would have to test shipment, and all remaining ruminants become established, and would be as (both positive and negative) would need negative to an approved serological test. difficult to eliminate as the types If any of the ruminants has a positive to be retested with either negative, already present in the United States. decreasing, or stabilized test results at test result to this second test, and it is Bovine ephemeral fever, RVF and WB a season of the year in the exported least 30 days following the first test. are viruses that could also find ready region when insect vectors are active, For ruminants to be imported from vectors in the United States because then the remaining animals may not be regions classified as Risk Class R3, R4, they are transmitted by Culicoides or imported during the insect vector or RU for aino or akabane, the mosquitoes. The incubation periods for season. If it is a season of the year when ruminants would be required to be these viruses is much longer than for insect vectors are not active, then the accompanied by certification that they Akabane and Aino. In each case, the ruminants testing positive may be did not originate from a herd that has virus either produces prolonged removed and the remaining animals been known to be infected with aino viremias even after the appearance of may be imported if they all test negative and/or akabane within 12 months of the antibody, or there is insufficient history to a retest at least 30 days following the date of export. Additionally, if the about the duration of the viremia. Any previous test. ruminants are offered for export during animal with specific antibody with any The imported ruminants would need a time of the year when vectors are of these agents from affected regions to be quarantined for at least 15 days at active, the certification would need to would be avoided, because they present a post-importation quarantine facility state that the ruminants were a moderate, high or unknown risk of designated and approved by the quarantined for at least 60 days prior to introducing virus into the United States. Administrator if imported during a export in a vector-proof facility Serologically positive animals with season of the year in the United States approved by the Administrator and by stable titers may be introduced safely if when insect vectors are not active, and the national veterinary services in the they are negative to virus isolation tests. must be quarantined for 60 days if country of origin. If the ruminants are To be imported from regions imported during a season of the year offered for export during a time of the classified as Risk Class R1 or R2 for BT, when insect vectors are active in the year when insect vectors are not active, EHD, BEF, RVF, and WB, ruminants United States. During this quarantine the certification would need to state that would be required to be accompanied period, the ruminants would need to at least 60 days has passed since the by certification that they have resided test negative to an approved serological first killing frost of the season. The for at least 60 days prior to export only test for BT, EHD, BEF, RVF, and or WB certification would also need to state on premises located in regions classified virus. that the ruminants were tested twice as Risk Class RN, R1, or R2, and also with negative results to approved that they have had a negative result to Nairobi Sheep Disease serological tests for aino and/or akabane an approved serological test for BT, In this proposal, § 93.415(n) sets forth virus, at least 30 days apart, with the EHD, BEF, RVF, and/or WB virus. If any requirements for the importation of second test conducted within 30 days of the ruminants in the group test ruminants from regions classified as prior to export. If any of the ruminants positive, then the remaining ruminants Risk Class R1 through RU for Nairobi in the shipment tested positive, then the could be imported only if they qualify sheep disease (NSD, also known as same procedure as for R1 and R2 regions as being from a Risk Class R3, R4, or RU Dugbe or Ganjam) virus. This is a tick- regarding retesting after removal of region. borne virus disease that has a relatively pregnant positives would be followed. To be imported from regions long incubation period and The ruminants would need to be classified as Risk Class R3, R4, or RU for convalescent carrier status. Animals quarantined for at least 15 days at a BT, EHD, BEF, RVF, and WB, ruminants without antibody titers from affected post-importation quarantine facility, that are offered for export during a regions would be difficult to find in the during which time the ruminants must season of the year when insect vectors population, because the infection rate in have negative, decreasing, or stabilized are active, or less than 60 days after the affected regions is often quite high. 17006 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

Serologically positive animals with tick-borne encephalitis, or Louping Ill is disease, does find a number of vectors. stabilized titers may be safely imported prohibited importation into the United Once an animal becomes infected with if they are negative upon virus isolation. States. Ruminants intended for these agents it probably remains Any ruminant vaccinated for NSD importation from regions classified as infected for life. virus would be prohibited importation Risk Class R1 or R2 for Cowdria Any ruminant that has been into the United States. Ruminants ruminantium, tick-borne encephalitis, vaccinated for Theileria is prohibited intended for importation from regions or Louping Ill would be required to be importation into the United States. classified as Risk Class R1 or R2 for NSD accompanied by certification that the Ruminants intended for importation would be required to be accompanied ruminants have resided on premises from regions classified as Risk Class R1 by certification that the ruminants have located in RN, R1, or R2 regions for at or R2 for Theileria would be required to resided for at least 60 days in RN, R1, least 60 days immediately prior to be accompanied by certification that the or R2 regions, and that the ruminants export and have had a negative result to ruminants, for at least 1 year have tested negative to an approved an approved serological test for Cowdria immediately prior to export, have serological test for NSD virus within 30 ruminantium, tick-borne encephalitis, resided only on premises located in RN, days prior to export to the United States. and/or Louping Ill within 30 days prior R1, or R2 regions, and have had a If any of the ruminants test positive, to export. negative result to an approved then the remainder of the animals Ruminants intended for importation serological test for Theileria within 30 would have to meet the requirements for from regions classified as Risk Class R3, days prior to export. ruminants from Risk Class R3, R4, or RU R4, or RU for Cowdria ruminantium, Ruminants intended for importation regions. tick-borne encephalitis, or Louping Ill from regions classified as Risk Class R3, Ruminants intended for importation would be required to be accompanied R4, or RU for Theileria would be from regions classified as Risk Class R3, by certification that the ruminants were required to be quarantined for at least 60 R4, or RU for NSD would have to be quarantined for at least 60 days days prior to export in a vector-proof accompanied by certification that the immediately prior to export in a vector- facility approved by the Administrator ruminants were quarantined, for at least proof facility approved by the and the National Veterinary Services of 60 days prior to export, in a vector-proof Administrator and the National the country of export, and that, during facility approved by the Administrator Veterinary Services in the country of this quarantine period, the ruminants and by the national veterinary services export, and that during the quarantine tested negative twice, at least 30 days of the country of origin, and that, during period the ruminants were tested apart, to an approved serological test for this quarantine period, the ruminants negative twice, within 60 days prior to Theileria. Additionally, the ruminants tested negative twice, within 60 days export and at least 30 days apart, using would need to be quarantined for at prior to export and at least 30 days an approved serological test for Cowdria least 30 days at a post-importation apart, using an approved serological test ruminantium, tick-borne encephalitis, quarantine facility designated and for NSD virus. If any ruminants in the and/or Louping Ill. Additionally, the approved by the Administrator, and, shipment tested positive to the first ruminants must be quarantined for at during this period, would need to test serological test, then all ruminants least 30 days at a post-importation negative at least once using an approved (positive and negative) would need to be quarantine facility designated and serological test for Theileria. retested at least 30 days following the approved by the Administrator, during Besnoitia Besnoiti, Vesicular Stomatitis, previous test, with negative, decreasing, which time the ruminants must be Lumpy Skin Disease, and Parafilaria or stabilized test results. Only those tested negative at least once using an Bovicola animals that were negative to both tests, approved serological test. In this proposal, § 93.415(r) sets forth or that were negative on virus isolation Theileria procedures could be imported into the requirements for the importation of United States. In this proposal, § 93.415(p) sets forth ruminants from regions classified as Additionally, the ruminants from the requirements for the importation of Risk Class R1 through RU for globidiosis R3, R4, and RU regions would need to ruminants from regions classified as due to Besnoitia besnoiti, lumpy skin be quarantined for at least 15 days at a Risk Class R1 through RU for Theileria disease (LSD) virus, and parafilariosis post-importation quarantine facility spp. Of particular concern for cattle are caused by Parafilaria bovicola in approved by the Administrator, and T. parva, the cause of east coast fever; ruminants. would need to test negative to an T. lawrencei, the cause of Corridor Any animal that has been vaccinated approved serological test during that disease; and T. annulata, the cause of for Besnoitia besnoiti, LSD, or quarantine. Mediterranean fever; and, for sheep and Parafilaria bovicola is prohibited goats, T. hirci, the cause of malignant importation into the United States. Cowdria ruminantium, Tick-Borne bovine or caprine theileriosis. Theileria Ruminants offered for importation from Encephalitis, and Louping Ill are transmitted by ticks, and are rather regions classified as R1 or R2 for In this proposal, § 93.416(o) sets forth host specific both for the primary hosts Besnoitia besnoiti, LSD, or Parafilaria importation requirements for ruminants and for the vector. The specific bovicola, would be required to be intended for importation from regions Theileria species are usually not found accompanied by certification that, for at classified as Risk Class R1 through RU outside the range of their secondary host least 60 days prior to export, the for heartwater due to Cowdria tick. The primary control mechanism is animals have resided only on premises ruminantium, tick-borne encephalitis, to keep the transmitting tick out of the located in Risk Class RN, R1, or R2 and Louping Ill, which is a form of tick- United States, but there is also some regions, and have had a negative result borne encephalitis. These diseases are concern with Theileria-infected to an approved serological test for the tick-borne infections that have long animals, because there may be native disease in question within 30 days prior carrier periods and that may be able to ticks in the United States that could to export to the United States. be transmitted by ticks already present transmit one or more of these agents. T. Ruminants offered for importation in the United States. mutans is a species that is found from regions classified as R3, R4, or RU Any ruminant that has been throughout the world, and although for Besnoitia besnoiti, LSD, or vaccinated for Cowdria ruminantium, apparently not associated with any Parafilaria bovicola, must be Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17007 accompanied by certification that the accompanied by certification that the negative twice, at least 30 days apart, to animals were quarantined and isolated, animals originated from premises that an approved serological test for NTT- for at least 60 days prior to export, from have not had trypanosomiasis diagnosed Trypanosomes, TBF, and/or BPF. all animals not part of the shipment, in during the previous 24 months, that If the ruminants are imported during a vector-proof facility approved by the they were quarantined and isolated for a season of the year when vectors are Administrator. During this quarantine, at least 60 days prior to export in a not active in the United States, they the animals would need to be tested vector-proof facility approved by the would be required to be quarantined for negative twice, at least 30 days apart, Administrator, and that during the pre- at least 15 days at a post-importation using an approved serological test for embarkation quarantine period, they quarantine facility designated and Besnoitia besnoiti, LSD, and/or had negative results to an approved approved by the Administrator. The Parafilaria bovicola. Additionally, the serological test for trypanosomes. post-importation quarantine period animals would need to be quarantined Additionally, the ruminants and swine would need to be at least 60 days if the for at least 15 days at a post-importation would need to be quarantined for at ruminants are imported during a season quarantine facility designated and least 30 days at a post-importation of the year when vectors are active in approved by the Administrator, and, quarantine facility designated and the United States. In either case, during during this quarantine, would need to approved by the Administrator, and, the post-importation quarantine period, be tested negative at least once using during this quarantine period, would the ruminants would need to test approved serological tests. need to be tested negative at least once negative to an approved serological test for trypanosomes using an approved for NTT-Trypanosomes, TBF, and/or Trypanasomes Transmitted by Tsetse serological test. BPF. Flies In this proposal, §§ 93.415(q) and Trypanosomes Transmitted Other Than Vesicular Stomatitis Virus 93.515(i) specify importation by Tsetse Flies In this proposal §§ 93.415(t) and requirements for ruminants and swine, In this proposal, § 93.415(s) sets forth 93.515(j) set forth importation respectively, from regions classified as importation requirements for ruminants requirements for ruminants and swine, Risk Class R1 through RU for tsetse fly from regions classified as Risk Class R1 respectively, from regions classified as transmitted Trypanosoma spp. through RU for Trypanosoma spp. that Risk Class R1 through RU for vesicular including T. brucei, T. congolense, T. affect ruminants and that are stomatitis virus (VSV). evansi, T. simiae, T. suis, T. uniforme, transmitted by species other than tsetse Ruminants and swine intended for and T. vivax. The tsetse fly does not flies (Glossina spp.) (NTT- importation from regions that are occur outside of Africa, but some of the Trypanosomas), tick-borne fever due to classified as Risk Class R1 for VSV trypanosomes that are found to be Erlichia (Cytoecetes) phagocytophilia, or would be required to be accompanied transmitted by the tsetse fly have been bovine petechial fever due to Erlichia by certification that the ruminants and able to be transmitted by Tabanids and (Cytoecetes) ondiri. The NTT- swine have resided for at least 60 days other biting flies, which allows them to Trypanosomas include T. brucei, T. prior to export only on premises located become established outside the areas of evansi, and T. vivax, which may also be in Risk Class RN or R1 regions for VSV, tsetse fly presence. Trypanosoma vivax transmitted by biting flies other than and have not been vaccinated for VSV. has become established throughout tsetse. Trypanosoma evansi causes a Ruminants and swine intended for South and Central America, where it is disease called surra that affects importation from regions that are transmitted by species other than the primarily equines, camels, goats, and classified as Risk Class R2 for VSV tsetse fly, and T. evansi is primarily carnivores, but cattle may be would be required to be accompanied transmitted by biting flies other than the asymptomatic carriers of the parasite. by certification that the ruminants and tsetse fly. It is possible that some native Any ruminant that has been swine have resided for a minimum North American biting flies could vaccinated for NTT-Trypanosomes, period of time (60 days for ruminants; become adapted to transmit one or more TBF, or BPF is prohibited importation 30 days for swine) prior to export only of the Trypanosomes, so care must be into the United States. Ruminants on premises located in Risk Class RN, taken to assure that animals infected offered for importation from regions R1 or R2 regions for VSV, that the with the parasites are not imported. classified as Risk Class R1 or R2 for animals have not been vaccinated with Once an animal is infected, it probably NTT-Trypanosomes, TBF, and/or BPF any live attenuated vaccines for VSV, remains infected for life. would be required to be accompanied and that the animals have not been Any ruminant or swine that has been by certification that the ruminants have vaccinated with inactivated vaccines for vaccinated for trypanosomes may not be resided for their entire life only on VSV within 60 days prior to export. imported into the United States. premises located in regions classified as Ruminants and swine intended for Ruminants and swine to be imported Risk Class RN, R1, or R2, and have had importation from regions that are from regions classified as R1 or R2 for a negative result to an approved classified as Risk Class R3, R4, or RU for African trypanosomes and tsetse flies serological test for NTT-Trypanosomas, VSV would be required to be would be required to be accompanied TBF, and/or BPF within 30 days prior accompanied by certification that the by certification that the ruminants have to export. ruminants and swine have not been resided only on premises located in Risk Ruminants offered for importation vaccinated with any live attenuated Class RN, R1, or R2 regions for from regions classified as Risk Class R3, vaccines for VSV, have not been trypanosomes and tsetse flies for their R4, or RU for NTT-Trypanosomas, TBF, vaccinated with inactivated vaccines for entire life, and have had a negative or BPF would be required to be VSV within 60 days prior to export, and result to an approved serological test for accompanied by certification that the have not been located on any premise African trypanosomes within 30 days ruminants were quarantined for at least where VSV has occurred within 60 days prior to export to the United States. 60 days prior to export, in a vector-proof prior to export. Additionally, if the Ruminants and swine to be imported facility approved by the Administrator animals are exported during a season of from regions classified as Risk Class R3, and the National Veterinary Services of the year when insect vectors were R4, and RU for African trypanosomes the country of origin, and that, during active, the certification must state that and tsetse flies would be required to be the quarantine, the ruminants tested the animals were quarantined and 17008 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules isolated from all other animals not part Virus, and have had a negative result to veterinarian, case, contagious disease, of the shipment for at least 30 days prior an approved serological test for JEV driven, ectoparasites, equivalent test, to export in a vector-proof facility and/or Getah within 30 days prior to exposed, identification, import approved by the Administrator, and, export. (imported, importation) into the United during the pre-embarkation quarantine Swine intended for importation from States, livestock, official seal, operator, period, had negative results to an regions classified as Risk Class R2 for permitted treatment, post-importation approved serological test for VSV within JEV or Getah Virus would be required to quarantine, pre-embarkation quarantine, 14 days prior to export. If the ruminants be accompanied by certification that the quarantine, region, restricted agents, and swine are imported during a season swine have resided for at least 60 days risk class regions, susceptible animals, of the year when insect vectors are only on premises located in Risk Class trail, transported, vector-borne disease, active within the United States, the RN, R1, or R2 regions. The certification and Veterinarian in Charge. animals must be quarantined for at least would also need to state that the swine Additionally, in proposed § 93.400 we 15 days at a post-importation quarantine have undergone a 30-day pre- would add a definition of approved facility designated and approved by the embarkation quarantine, which, if bovine tuberculosis test, and in Administrator, and, during the post- conducted during a time of year when proposed § 93.500 we would add a importation quarantine period, the insect vectors are active, would need to definition of approved pseudorabies animals must have negative results to an be in a vector-proof facility approved by test. approved serological test for VSV. the Administrator. Additionally, the certification would need to state that the Part 94 Japanese Encephalitis and Getah swine have tested negative to an The regulations in current 9 CFR part In this proposal, § 93.515(f) sets forth approved serological test for JEV and/or 94 govern the importation into the importation requirements for swine Getah within 30 days prior to export. United States of specified animals and from regions classified as Risk Class R1 The swine would also need to undergo animal products, in order to prevent the through RU for Japanese encephalitis a post-importation quarantine of at least introduction into the United States of virus (JEV) and Getah virus in swine. 15 days at a facility designated and various animal diseases, including Japanese encephalitis virus (JEV) is a approved by the Administrator. rinderpest, foot-and-mouth disease, flavivirus transmitted by various species Swine intended for importation from bovine spongiform encephalopathy, primarily of the genus Culex found regions classified as Risk Class R3, R4, African swine fever, hog cholera, and throughout eastern Asia. The disease or RU for JEV or Getah Virus would be swine vesicular disease. These are primarily affects horses and humans, required to be accompanied by dangerous and destructive but swine and birds are the primary certification that they have undergone communicable diseases of ruminants reservoir and amplifying host for the pre-embarkation quarantine for at least and swine. Part 94 also restricts the virus. The disease is primarily 60 days immediately prior to export. If movement of certain garbage, and the inapparent in swine, except in pregnant the quarantine is conducted during a importation of carcasses, products, and sows, in which stillborn and weak pigs time of the year when insect vectors are eggs of poultry, game birds, and other may be born. The disease can also cause active, it would have to be carried out birds. infertility in breeding boars. in a vector-proof facility approved by Under the regulations in current part The viremia in swine may persist the Administrator. 94, countries are identified in which throughout the vector season and While in pre-embarkation quarantine, rinderpest, foot-and-mouth disease, provide a constant source of virus for the swine would also need to test African swine fever, hog cholera, swine mosquitoes. Although the introduction negative twice, within 60 days prior to vesicular disease, and/or bovine of this virus into North America is a export and at least 30 days apart, to an spongiform encephalopathy are constant threat, it is not known whether approved serological test for Japanese considered to exist. Also under part 94, the virus could be established if encephalitis and/or Getah. swine and/or ruminants from these introduced. Infected swine would be the If the swine are imported during a countries are prohibited or restricted most likely means of introducing the time of the year when vectors are active importation into the United States. infection, as infected horses and in the United States, the swine would Certain of the conditions governing humans usually have a very short, low- need to be quarantined for at least 60 restricted importation are set forth in level, viremia that cannot infect days at a post-importation quarantine current part 94. The remainder of the mosquitoes. facility designated and approved by the conditions are set forth in current part Getah virus is an alphavirus with Administrator. Otherwise, the post- 92, in either subpart D (ruminants) or roughly the same distribution and importation quarantine would need to subpart E (swine). vectors as JEV. It causes similar be at least 15 days. In either case, during In this proposed rule, we are problems in swine as does JEV virus. the post-importation quarantine, the proposing to remove from part 94 all Swine and horses are the primary swine would need to test negative to provisions regarding the existence of amplifying hosts for this virus, and JEV and/or Getah virus, using approved diseases affecting ruminants or swine in affected horses may develop a febrile serological tests. specific countries, and all provisions illness characterized by skin lesions and regarding the importation of live edema. Pregnant sows may have Definitions animals. reproductive failure due to Getah virus In §§ 93.400 (ruminants) and 93.500 The provisions in current part 94 that infection. (swine) of this proposed rule, we have list countries in which specific diseases Swine intended for importation from added definitions to those already affecting ruminants and swine are regions classified as Risk Class R1 for included in current §§ 92.400 and considered to exist would not be JEV or Getah Virus would be required to 92.500. The definitions that would be necessary, because they would be be accompanied by certification that the added in both §§ 93.400 and 93.500 are: replaced by the criteria for risk class swine have resided for at least 60 days Adjacent regions, affected animals, levels we are proposing to set forth in immediately prior to export only on affected premises or regions, approved revised part 92, discussed above. premises located in regions classified as brucellosis test, approved tests for (However, until there is future Risk Class RN or R1 for JEV or Getah restricted diseases or agents, authorized rulemaking on the provisions in current Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17009

§ 94.6 regarding the importation of eggs, the disease in question require, among a country free of a particular disease, carcasses, and other products from other requirements, cooking or curing of and meat and meat products could be poultry or birds, those provisions would the meat or meat products. In this imported from those countries with remain the same and continue to be proposed rule, except as discussed in little restriction. based on specified countries where this ‘‘Supplementary Information’’ Under this proposal, regions classified exotic Newcastle disease or S. under the heading ‘‘Proposed § 94.5,’’ as Risk Class R1 would be similar to enteritidis is considered to exist.) we are proposing essentially to retain those countries listed in current All requirements for the importation the cooking and curing requirements in §§ 94.11 and 94.13, that are considered of live animals would be incorporated the current regulations for meat and to be free of a disease, but that present into the importation requirements in meat products intended for importation some increased risk due to importation proposed part 93, discussed above. So from countries where rinderpest, foot- practices or proximity to countries that, as revised, part 94 would include and-mouth disease, bovine spongiform affected with a disease. Meat and meat only restrictions and requirements for encephalopathy, African swine fever, products from Risk Class R1 countries the importation of meat and other hog cholera, or swine vesicular disease could be imported only if certain animal products, and for the movement exists. The requirements for all cooked specified requirements, discussed below of regulated garbage into the United or cured meat products, other than those are met. States. that are dry-cured, would be set forth in Proposed Risk Class R2 would be a Section 94.1(a) of the current new § 94.5. The requirements for dry- risk class that essentially straddles our regulations sets forth a list of countries cured products that are set forth in current designations of ‘‘free’’ and ‘‘not- considered to be free of both rinderpest § 94.17 of the current regulations are set free.’’ As defined in this proposal, a Risk and foot-and-mouth disease. All forth in § 94.11 of this proposal. Class R2 region would be one in which countries not on this list are considered The current regulations in part 94, in a particular disease is not known to to be those in which rinderpest or foot- most cases, do not set forth exist, but in which vaccination of and-mouth disease exists. A similar list requirements for the importation of animals for the disease is carried out or for countries considered free of hog fresh, chilled, or frozen meat from the disease has recently been known to cholera is set forth in § 94.9. Section foreign countries. This is because, under exist. Under our current policy, such a 94.8 of the current regulations sets forth the current regulations, in most cases, country would not be considered free of a list of countries in which African either a country is considered to be one a disease, for reasons discussed above in swine fever is considered to exist, and in which a particular disease exists, or this SUPPLEMENTARY INFORMATION, under §§ 94.12(a) and 94.18(a) set forth such it is considered free of the disease. If the the heading ‘‘Risk Class R3 Regions.’’ lists for swine vesicular disease and disease exists in the country, meat from Under this proposal, however, an R2 bovine spongiform encephalopathy, that country must be cooked or cured region would be one that does not respectively. As noted above, these lists before importation. If the country is present as much risk as a region in would not be necessary under the considered free of the diseases, meat which the disease exists (R3, R4, RU), regionalized approach to risk class and meat products may be imported but that presents a greater risk than a levels set forth in this proposed rule. from that country with relatively few region in which vaccination is not Therefore, we are proposing to remove restrictions. The only exceptions to this carried out (RN, R1). them from the regulations. Additionally, ‘‘free/not free’’ approach in part 94 are Regions in the proposed Risk Class current § 94.1a, which sets forth criteria the provisions in §§ 94.11 and 94.13, R3, R4, and RU levels would, under the for determining the separate status of a which list countries in which current regulations, be considered territory or possession as to rinderpest rinderpest/foot-and-mouth disease or countries in which a particular disease and foot-and-mouth disease, would be swine vesicular disease, respectively, is considered to exist. Under this removed. are not considered to exist, but that are proposal, meat and meat products from In the current regulations, each of the considered to present some risk of these regions, with the exceptions paragraphs listing those countries in disease introduction due to their discussed below, would be prohibited which specified disease exists, except importation policies or proximity to importation, just as they are under the for those in § 94.1 for rinderpest and countries in which the disease exists. current regulations. The requirements foot-and-mouth disease, are followed by Meat to be imported from countries for importation of meat and meat provisions for the restricted importation listed in §§ 94.11 or 94.13 must either be products from the different risk class of meat and meat products from those cooked (in the case of swine vesicular levels are discussed below. countries. Similar provisions for meat disease) or must be accompanied to the Prohibitions from rinderpest and foot-and-mouth United States with certification that the disease-affected countries are set forth facility where the animals were The importation of fresh, chilled or in current § 94.4. slaughtered follows preparation and frozen meat from swine in regions Additionally, current § 94.11 includes processing practices to ensure it does classified as Risk Class R3, R4, or RU for requirements for the importation of not handle contaminated meat, and also hog cholera, African swine fever, or meat and other animal products from that the animals to be slaughtered have swine vesicular disease would be countries that are free of rinderpest and never been in a country affected with prohibited (proposed § 94.1(b)). The foot-and-mouth disease, but that present the disease in question. destruction of virus in fresh meat by some disease risk due to their Under the risk class levels that would methods generally employed to process importation policies or their proximity be established by this proposal, the fresh meat are not sufficient to remove to a country in which the diseases exist. number of disease-risk categories a hog cholera, African swine fever, or Similar provisions regarding swine country could fall into would be swine vesicular disease from swine vesicular disease are set forth in current expanded from ‘‘free,’’ ‘‘not free,’’ or meat, or bovine spongiform § 94.13. ‘‘free with some risk,’’ to any one of six encephalopathy from bovine meat. In all of the sections described in the different risk classes. This proposal would, in § 94.1(a), above two paragraphs, the requirements Regions classified as RN for a prohibit the importation of fresh, for the importation of meat and meat particular disease would, under the chilled, or frozen meat of ruminants or products from countries affected with current regulations, be considered to be swine from regions classified as Risk 17010 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

Class R4 or RU for rinderpest or foot- export; (4) the meat originated from has not been in contact with meat from and-mouth disease, and, in § 94.1(c), premises located in regions where foot- regions that are classified as Risk Class would prohibit the importation of fresh, and-mouth disease or rinderpest has not R3, R4 or RU for African swine fever, chilled, or frozen meat of ruminants been diagnosed within the previous 12 hog cholera, and/or swine vesicular from Risk Class R4 or RU levels for months; (5) the meat originated from disease; (3) the meat originated from bovine spongiform encephalopathy. premises on which ruminants and premises where African swine fever, We believe that fresh, chilled, or swine have not been vaccinated with hog cholera, and/or swine vesicular frozen meat can be imported from modified or attenuated live viruses for disease has not been present during the regions classified as R3 for rinderpest or foot-and-mouth disease at any time lifetime of swine slaughtered for export; foot-and-mouth disease, because an R3 during the lifetime of any of the (4) the meat originated from premises region is by definition regarded as a ruminants or swine slaughtered for located in regions where African swine region of low disease prevalence. The export; (6) the meat originated from fever, hog cholera, and/or swine GATT sanitary and phytosanitary ruminants or swine that have not been vesicular disease has not been provisions allow imports from low vaccinated for rinderpest, African swine diagnosed within the previous 12 prevalence regions for FMD and fever, hog cholera or swine vesicular months; (5) the meat originated from rinderpest, and the virus in FMD and disease at any time during the lifetime premises on which ruminants and rinderpest carrier animals is largely of any of the ruminants or swine swine have not been vaccinated with eliminated by deboning and standard slaughtered for export; (7) all bone, modified or attenuated live viruses for curing of the meat, by which the meat blood clots, and lymphoid tissue have foot-and-mouth disease at any time is hung for 36 hours to increase its been removed from the meat; and (8) the during the lifetime of any of the swine tenderness. Quantitative risk meat comes from carcasses that have slaughtered for export; (6) the meat assessments done for meat estimate that been allowed to maturate at 40° to 50°F originated from swine that have not meat from fewer than 7 per billion FMD- (4° to 10°C) for a minimum of 36 hours been vaccinated for rinderpest, African infected animals would still be infective after slaughter and have reached a swine fever, hog cholera or swine after the standard curing and deboning maximum pH of 6.0 in the loin muscle vesicular disease at any time during the process. at the end of the maturation period. As lifetime of any of the swine slaughtered Importation Requirements for Fresh, proposed, any carcass in which the pH for export; and (7) all bone, blood clots, Chilled, or Frozen Meat of Ruminants does not reach a maximum of 6.0 may and lymphoid tissue have been removed and Swine be allowed to maturate an additional 24 from the meat. hours and be retested, and, if the carcass Our primary concern regarding meat Under § 94.1(d) of this proposed rule, still does not reach a maximum pH of from regions classified as Risk Class R2 fresh, chilled, or frozen meat from 6.0 after 60 hours, the meat from the for African swine fever, hog cholera, ruminants and swine raised and carcass may not be imported into the and/or SVD would be possible residual slaughtered in regions classified as Risk United States. virus infection on previously infected Class RN or R1 for foot-and-mouth The rationale for proposed premises in the region, and also some disease, rinderpest, bovine spongiform requirements ‘‘(5)’’ through ‘‘(8),’’ above, risk of recent introductions from encephalopathy, African swine fever, is as follows: Vaccination with modified adjacent affected areas. The certification hog cholera, and/or swine vesicular or attenuated live viruses for foot-and- of the premises of origin as being free of disease could be imported into the mouth disease could create the risk of the disease would be the principal United States provided the authorized the live virus being present in meat method of risk mitigation in these official of the exporting country certifies imported into the United States. regions. We believe this would create on the required foreign meat inspection Because any vaccine that currently little hardship in these areas, because certificate that the shipment originated exists for rinderpest, African swine fewer than 0.1% of the farms would be in regions that are classified as Risk fever, hog cholera, or swine vesicular expected to have a recent history of one Class RN or R1 for the disease in disease contains a live virus, all of these diseases. Because the only question, and that the meat has not been vaccination for those diseases would be proven method of eliminating the in contact with meat from regions that prohibited. The proposed requirement diseases is complete herd depopulation are classified as Risk Class R2, R3, R4, that certain parts of the animal product of the affected premises and restocking or RU regions for the disease in be removed is necessary because those with fresh swine after a suitable fallow question. locations on the carcass can be period, such a restocked herd would Under proposed § 94.1(e), fresh, reservoirs of the disease agent. The qualify for export, since none of the chilled, or frozen meat from ruminants requirement that a maximum pH of 6.0 restocked swine would have been or swine raised and slaughtered in be reached would be necessary to present when the restricted disease regions that are classified as Risk Class ensure any foot-and-mouth disease agent was present. R2 for foot-and-mouth disease or agent has been destroyed. Under § 94.1(g) of this proposal, fresh, rinderpest could be imported into the Under § 94.1(f) of this proposal, fresh, chilled, or frozen meat from ruminants United States provided that the chilled, or frozen meat from swine or swine raised and slaughtered in authorized official of the exporting raised and slaughtered in regions that regions that are classified as Risk Class country certifies the following: (1) The are classified as Risk Class R2 for R3 for foot-and-mouth disease and/or shipment originated in a region African swine fever, hog cholera, and/or rinderpest could be imported into the classified as Risk Class RN, R1, or R2 for swine vesicular disease could be United States, provided the authorized foot-and-mouth disease or rinderpest in imported into the United States official of the exporting country certifies ruminants or swine; (2) the meat has not provided that the authorized official of the following: (1) The shipment been in contact with meat from Risk the exporting country certifies the originated from a region that is Class R3, R4 or RU regions; (3) the meat following: (1) The shipment originated classified as Risk Class RN, R1, R2 or R3 originated from premises where foot- from regions that are classified as Risk for foot-and-mouth disease and/or and-mouth disease or rinderpest has not Class RN, R1, or R2 for African swine rinderpest; (2) the meat has not been in been present during the lifetime of any fever, hog cholera, and/or swine contact with meat from regions that are ruminants or swine slaughtered for vesicular disease in swine; (2) the meat classified as Risk Class R4 or RU for Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17011 foot-and-mouth disease and/or been known to be present; (4) the meat Proposed § 94.3 rinderpest; (3) the meat originated from originated from premises where protein premises where foot-and-mouth disease of ruminant origin has not been fed to Section 94.2(a) of the current and rinderpest have not been present ruminants during the lifetime of any regulations prohibits the importation of during the lifetime of any ruminants or animals currently living on the fresh, chilled, or frozen products (other swine slaughtered for export; (4) the premises; (5) the meat is from cattle that than meat, and milk and milk products) meat originated from premises where have not been in any region classified as derived from ruminants or swine foot-and-mouth disease and/or Risk Class R3, R4 or RU for bovine originating in, shipped from, or rinderpest has not been diagnosed spongiform encephalopathy during any transiting any country designated as one within 15 statute miles (25 kilometers) period when the region permitted the in which rinderpest or foot-and-mouth within the previous 12 months; (5) the use of ruminant protein in ruminant disease exists. An exception to this meat originated from premises on which feed; and (6) the cattle were examined prohibition is made in current § 94.3 for ruminants and swine have not been prior to slaughter by a veterinarian organs, glands, extracts, or secretions of vaccinated with modified or attenuated employed by the national government of ruminants and swine that are imported live viruses for foot-and-mouth disease the country in which the ruminants for pharmaceutical or biological at any time during the lifetime of any of were slaughtered, and were found not to purposes, and in current parts 95 and 96 the ruminants or swine slaughtered for display any signs indicative of a for other specified animal products, export; (6) the meat originated from neurological disorder. We believe such as casings, glue stock, etc., ruminants or swine that have not been requirements ‘‘(4)’’ and ‘‘(5),’’ above, processed under certain conditions. vaccinated for rinderpest, African swine regarding ruminant feed, are necessary In this proposed rule, we would fever, hog cholera or swine vesicular because the bovine spongiform redesignate § 94.2(a) as § 94.3(a) and disease at any time during the lifetime encephalopathy agent can exist in, and apply its prohibitions to regions of any of the ruminants or swine be transmitted by, feed processed from classified as Risk Class R3, R4, or RU for slaughtered for export; (7) the meat has ruminants infected with the disease. rinderpest, foot-and-mouth disease. all bone, blood clots, and lymphoid Because the symptoms of bovine Under this proposal, regions classified tissue removed; (8) the meat comes from spongiform encephalopathy include as Risk Class R3, R4, or RU are carcasses that have been allowed to neurological disorder, cattle exhibiting considered those in which the disease maturate at 40° to 50°F (4° to 10°C) for such a disorder must be presumed to be in question exists. a minimum of 36 hours after slaughter affected with the disease. Current § 94.2(b) prohibits the and that have reached a maximum pH Under § 94.1(i) of this proposal, fresh, importation of milk and milk products of 6.0 in the loin muscle at the end of chilled or frozen meat derived from from countries in which FMD or the maturation period (any carcasses in animals in the family Cervidae from rinderpest exists. This paragraph would which the pH did not reach a maximum regions that are classified as Risk Class be redesignated as § 94.3(b). In addition of 6.0 may be allowed to maturate an R2, R3, or R4 for bovine spongiform to prohibitions because of FMD and additional 24 hours and be retested, and encephalopathy could be imported into rinderpest, we are proposing to also if the carcass still does not reach a the United States, provided the prohibit the importation of milk and maximum pH of 6.0 after 60 hours, the authorized official of the exporting milk products of ruminants and swine meat from the carcass may not be country certifies the following: (1) The originating in, shipped from, or exported to the United States); and (9) meat was derived either from wild transiting any region that is classified as the meat was held at no more than 40°F cervidae, or from farm-raised cervidae Risk Class R3, R4, or RU for Brucella (4°C) for a minimum of 14 days before that have never been fed ruminant melitensis. Under this proposal, such export, during which time the premises protein; (2) all bones and visually regions are those in which the disease of origin of all animals in the shipment identifiable lymphatic tissue and nerve is considered to exist. We are proposing remained free of foot-and-mouth tissue have been removed from the to add Brucella melitensis to this list disease, rinderpest, African swine fever, meat; (3) the meat is from cervidae that because it is exotic to the United States hog cholera, and swine vesicular have not been in any region classified as and is a hazard to both animals and disease. This 14-day period would be Risk Class R3, R4, or RU for bovine humans that may be exposed to fresh sufficient to ensure that the incubation encephalopathy during a period of time milk from infected animals. The period for the disease agent in question when the region permitted the use of primary concern with milk is the has elapsed. ruminant protein in ruminant feed; and possible feeding of raw milk or milk Under § 94.1(h) of this proposal, fresh, (4) the cervidae were examined prior to products to young ruminants or swine. slaughter by a veterinarian employed by chilled, or frozen meat from cattle from Proposed § 94.5 regions that are classified as Risk Class the national government of the country R2 or R3 for bovine spongiform in which the ruminants were As stated above, the cooking and encephalopathy could be imported into slaughtered, and were found not to processing requirements for meat the United States provided the display any signs indicative of a imported from countries in which authorized official of the exporting neurological disorder. diseases of concern exist, that are set country certifies the following: (1) The We believe it is warranted to provide forth in current §§ 94.4, 94.8, 94.9, shipment originated from a region that different requirements for the 94.11, 94.12, 94.13, and 94.18, would be is classified as Risk Class RN, R1, R2, or importation of cervidae from Risk Class consolidated in proposed § 94.5. Also, R3 for bovine spongiform R3 regions for BSE than for cattle, as noted above, the references to encephalopathy; (2) the meat has not because, as a general practice, cervidae countries in which a disease is been in contact with meat from regions feed by grazing and are less likely than considered to exist would be replaced that are classified as Risk Class R4 or RU cattle to have been fed ruminant protein by references to regions classified as for bovine spongiform encephalopathy; and to have been in contact with Risk Class R3, R4, or RU. All of the (3) the meat originated from premises ruminants infected with the disease. current regulations for such cooking and where, for at least 10 years, bovine Except in zoos, there have been no processing would be included in this spongiform encephalopathy has not reports of BSE in cervidae. proposed rule. 17012 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

Current § 94.5 includes provisions Therefore, we are proposing to extend being offloaded, and as long as their restricting the movement and handling the provisions accordingly, and include overland movement in the United States of certain international garbage. These them in proposed § 94.9(b). is confined to the port of arrival, we do provisions would remain unchanged by Sections 94.11 and 94.13 of the not believe that such meat or other this proposal, but would be current regulations set forth animal products pose a risk to livestock redesignated as § 94.6. requirements for the importation of in this country. Therefore, we are Current § 94.6 includes provisions meat and meat products from countries proposing in proposed § 94.9(d) to allow regarding the importation of carcasses, in which rinderpest, foot-and-mouth such movement. To qualify for such or parts or products of carcasses, and disease, and swine vesicular disease are transiting, notification of the transiting eggs (other than hatching eggs) of not known to exist, but that pose an would have to be made by the importer poultry, game birds, or other birds from increased disease risk due to to the Plant Protection and Quarantine countries where exotic Newcastle importation policies or proximity to Officer at the port of arrival prior to the disease or S. enteriditis is considered to affected countries. One of the transiting. The animal products and exist. These provisions would remain requirements for such importation is materials would have to be contained in unchanged by this proposal, but would that the meat or meat product be a sealed, leakproof carrier or container be redesignated as 94.7. prepared in inspected establishments or other means of conveyance, or, if the Current § 94.7 includes provisions for that are eligible to have their products container or carrier in which the animal the disposal of animals, meats, and imported into the United States under product or material is transported were other articles ineligible for importation the Federal Meat Inspection Act (21 offloaded in the United States for under the regulations regarding U.S.C. 601 et seq.) Current § 94.15(c) reshipment, it would have to remain rinderpest and foot-and-mouth disease allows meat and other animal products sealed at all times. The animal product in current § 94.1. In this proposal, we from countries listed in §§ 94.11 or or material could be held or stored for would redesignate current § 94.7 as 94.13, that were not prepared in eligible no more than 24 hours at the port of § 94.8 and amend it by removing all establishments, to be imported for arrival. references to animals and by expanding transit through the United States for Current § 94.16 includes importation the regulations so that they refer to immediate export. Under this proposal, requirements for specified milk and African swine fever, hog cholera, swine countries that are listed under §§ 94.11 milk products. In this proposal, these vesicular disease, and bovine and 94.13 would be classified as Risk provisions are set forth in § 94.9. The spongiform encephalopathy, as well as Class R1 or R2 regions. We are references in current § 94.16 to to rinderpest and foot-and-mouth proposing to provide in § 94.9(c) of this countries in which rinderpest or foot- disease. Provisions regarding the proposal that meat and other animal and-mouth disease exists have been disposal of animals are set forth in products from R1 or R2 regions that are changed to references to regions §§ 93.407 and 93.507 of this proposed not otherwise eligible for importation classified as Risk Class R3, R4, or RU for rule, for ruminants and swine, may transit the United States for rinderpest or foot-and-mouth disease. respectively. immediate export, provided the References to countries free of Current § 94.15(a) includes requirements of § 94.8(a) regarding rinderpest and foot-and-mouth disease requirements for products that would be notification and movement in a sealed have been changed to references to eligible for entry into the United States leakproof container are met. regions classified as RN, R1, or R2 for and that transit the United States for In § 94.9(d) of this proposal, we are the restricted diseases. Except for these export. These provisions would be set also proposing to add provisions to the and one other change, the provisions in forth in § 94.9(a) of this proposed rule, regulations that would allow the limited current § 94.16 would remain but would not otherwise be changed. transiting in the United States of meat unchanged. In proposed § 94.10(b)(2), Current § 94.15(b) includes provisions and other animal products not we are proposing to remove the that allow pork and pork products from otherwise eligible for entry into the requirement in current § 94.16(b)(2) that Chihuahua and Sonora, Mexico that are United States. This transiting would be dry milk products intended for not otherwise eligible for entry into the limited to movement at the port of importation must be processed for United States to transit the United arrival. Under the current regulations, if human food. We believe that as long as States for immediate export under a ship or aircraft that arrives in the they are processed in a manner specified conditions. These conditions United States is carrying meat or other determined by the Administrator to be include the obtaining of an APHIS animal products that are prohibited adequate to prevent the introduction of permit, movement from the region of entry into the United States, the livestock diseases into the United origin in a leakproof container with containers in which the meat or other States, their use does not need to be serially-numbered seals approved by animal products are contained may not restricted to human food. APHIS, submission of information to be offloaded from the means of We are also proposing to add a new APHIS concerning the route and seal conveyance to another means of § 94.10(f) that would provide that milk numbers of the shipment, and conveyance, even if the second means of or milk products from regions that are exportation from the United States conveyance is scheduled for immediate classified as Risk Class R3, R4, or RU for within a time limit specified on the departure from the United States. When Brucella melitensis may enter the permit. We do not believe that it is such offloading does occur, it is a United States only under the following necessary to limit the opportunity for violation of the regulations and the conditions: (1) The milk is pasteurized transiting to pork and pork products carrier is fined. This restriction has according to Food and Drug from Chihuahua and Sonora, and reduced the number of transport routes Administration (FDA) requirements; (2) believe that the provisions currently in available to producers and shippers of milk and milk products, including place for pork and pork products from meat and meat products. cheese, meet FDA requirements for Chihuahua and Sonora would be We believe that the current imported milk; (3) milk products, adequate to guard against disease risk regulations are unnecessarily restrictive. including cheese, are prepared from from any meat or meat product As long as meat and other animal milk treated according to current imported through a land border port for products are securely contained aboard requirements for milk from rinderpest transiting and immediate export. the carrier while in the port or while and foot-and-mouth disease countries, Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17013 in facilities that process only milk and mean ‘‘determination of whether meat United States without certification may milk products according to FDA has been thoroughly cooked by be disinfected, and would state instead requirements. observation of whether the flesh and that such casings may be forwarded to In this proposal, we are also juices have lost all red and pink color.’’ a USDA-approved facility for proposing to add provisions at new disinfection. We are proposing to make 9 CFR Part 95 § 94.13 that meat or meat products this change because the facilities in the consigned from the port of arrival to an The regulations in 9 CFR part 95 cities specified are no longer in approved establishment must be moved contain restrictions on the importation operation, and such disinfection, if it under Customs or APHIS seal, and must of certain animal products and hay and were necessary, could be done at any be otherwise handled as the straw in order to prevent the facility approved by APHIS. Administrator may direct in order to introduction of certain animal diseases. Finally, we are proposing to remove guard against the introduction and In this proposal, we are proposing to § 96.15, ‘‘Common carriers; marking dissemination of contagious diseases of make three types of substantive changes papers,’’ and § 96.16, ‘‘Form for livestock. The required seals would not to part 95. First, in each section where reporting release,’’ because they specify be permitted to be broken except by the current regulations refer to administrative procedures that have persons authorized by the Administrator ‘‘country’’ of origin, we would replace been discontinued for a number of to do so. the word ‘‘country’’ with the word years. Section 94.15 of this proposal ‘‘region.’’ Second, in each case where includes provisions for the cancellation reference is made to a country in which 9 CFR Part 98 of compliance agreements, and a particular disease is not considered to The regulations in 9 CFR part 98 provisions for the appeal of such a exist, we would refer instead to a region govern the importation of animal germ cancellation. classified as Risk Class RN, R1, or R2 for plasm so as to prevent the introduction We are also proposing to amend the disease in question. Third, in each of contagious diseases of livestock or current § 94.0, ‘‘Definitions,’’ to include case where reference is made to a poultry into the United States. definitions currently set forth in country in which a particular disease is In this proposal, we are proposing to § 94.4(h), and are proposing to add to considered to exist, we would refer replace references to ‘‘country’’ with part 94, in § 94.0, definitions of cervid, instead to a region classified as Risk references to ‘‘region’’ in the headings contact, pink juice test, region, Class R3, R4, or RU for the disease in for subparts A and B, and in §§ 98.3, restricted agents, risk class regions, question. ruminants, and veterinarian in charge. The sections in part 95 in which we 98.4, 98.7, 98.12, 98.13, 98.14, 98.15, The proposed definitions of region, would make the changes described 98.16, 98.17, and 98.34. Also, we would restricted agents, and risk class regions above are §§ 95.2, 95.4, 95.5, 95.7, 95.9, replace references to countries free of are the same as those in §§ 93.400 and 95.14, 95.15, 95.17, 95.21, and 95.23. rinderpest and foot-and-mouth disease 93.500 of this proposed rule. The Additionally, in § 95.28, which deals with references to regions classified as proposed definition of veterinarian in with hay, straw, grass, and similar Risk Class RN, R1, or R2 in the heading charge is the same as that used material, we would replace the for subpart A and in § 98.3, and would elsewhere (e.g., § 78.1) in the current reference to ‘‘tick-infested pastures, replace references to countries in which regulations. A definition of cervid ranges, and premises’’ with a reference rinderpest or foot-and-mouth disease would be included to make clear that to ‘‘regions classified as R3, R4, or RU exists with references to regions the term applies to all species of deer, for restricted ticks.’’ classified as Risk Class R3, R4, or RU in elk, and moose. Additionally, we would add the heading to subpart B, and in The proposed definition of contact definitions of region and risk class §§ 98.12, 98.13, 98.14, 98.15, 98.16, and reads as follows: ‘‘Known or potential regions to the definitions in § 95.1, and 98.34. commingling of products of animals would make several non-substantive Pending Proposed Rules during processing or storage, or while wording changes in part 95 for clarity being transported from any point to any and to clarify internal APHIS On May 11, 1995 (60 FR 25151– other point. Contact includes management procedures. 25162, Docket No. 94–085–2), APHIS simultaneous processing in the same published in the Federal Register a facility, or storage or shipment in the 9 CFR Part 96 proposed rule regarding the importation same room, locker, or container. but not The regulations in 9 CFR part 96 of sheep and goats and sheep and goat necessarily the same storage facility or govern the importation of animal germ plasm. That document proposed to conveyance, as long as security casings into the United States to prevent amend provisions concerning who may measures provided are determined to be the introduction of contagious livestock issue health certificates for ruminants adequate by an authorized APHIS diseases. offered for importation into the United representative.’’ The purpose of this We are proposing to replace States, and proposed to significantly definition is to set forth the various references to ‘‘country’’ in §§ 96.2 and revise the conditions for importing ways disease agents can be transmitted 96.3 with references to ‘‘region,’’ are sheep and goats and sheep and goat among animal products. proposing to replace the reference in germ plasm. The proposal also In § 94.0 of the current regulations, § 96.3 to countries free of African swine contained provisions concerning the definition of Indicator piece refers to fever to regions classified as Risk Class privately operated quarantine facilities meat to be used for the ‘‘pink juice test.’’ RN, R1, or R2 for African swine fever, for goats. Because no final rule has been This test is a visual method of and are proposing to replace the issued, those provisions are not determining whether meat has been references to countries in which reflected in this proposed rule. sufficiently heated to destroy the foot- specified diseases exist with references However, the provisions of Docket No. and-mouth disease virus. However, the to regions classified as Risk Class R3, 94–085–2 that are made final, and any current regulations do not define ‘‘pink R4, or RU for those diseases. future rulemaking affecting this juice test.’’ Therefore, to clarify the Additionally, in § 96.10, we would proposal (Docket No. 94–106–1), will be meaning of this term, we are proposing remove the references to specific cities reflected in the final rule to this to add a definition of pink juice test to in which casings that arrive in the proposal (Docket No. 94–106–1). 17014 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

National Performance Review classified regions would be used to marginal costs at different risk levels. This regulatory action is being taken establish importation requirements for However, data limitations, analytical as part of the National Performance particular animals and animal products complexity, and the inherent Review program to eliminate from those regions. We are also imprecision in calculating biological unnecessary regulations and improve proposing to allow, under certain risks and quantitative economic effects those that remain in force. conditions, the unloading and reloading make such comparisons impractical. at the port of arrival of meat and other The changes being proposed in this Executive Order 12866 and Regulatory animal products otherwise prohibited regulation are intended to comply with Flexibility Act entry into the United States. U.S. obligations under provisions This proposed rule has been reviewed This proposed rule, if adopted, would concerning sanitary and phytosanitary under Executive Order 12866. The rule revise the process for establishing (SPS) regulation in both the North has been determined to be economically United States importation policies American Free Trade Agreement regarding live ruminants and swine, and (NAFTA) and the World Trade significant and was reviewed by the the meat and products of such animals. Organization (WTO) Agreement on the Office of Management and Budget. Under this proposal, the United States Application of Sanitary and This proposed rule has been would in some cases look at the disease Phytosanitary Measures under the determined not to be major as provided risk in defined production regions, General Agreement on Tariffs and Trade by Public Law 103–354, the Federal rather than entire countries, and would (GATT) Uruguay Round agreements. Crop Insurance Reform and Department assess the risk of specific disease Although the two agreements differ in of Agriculture Reorganization Act of introduction according to risk class a few respects, both NAFTA–SPS and 1994. This law requires that certain levels, rather than only by WTO–SPS provide that: economically significant USDA rules determination of whether a region is or A member Country shall recognize the published in the Federal Register is not free of a particular disease. concepts of regions of low pest or include an analysis of the risks, costs, This proposed rule is a departure disease prevalence, and shall ensure and benefits of the action, and that this from the current regulations in that a that its sanitary and phytosanitary analysis be reviewed by the USDA region would not be classified simply as measures are adapted to take into Office of Risk Assessment and Cost one in which a specific disease is or is account the characteristics of regions Benefit Analysis. However, P.L. 103–54 not known to exist. Rather, a region in from which products originate and to applies this requirement only to rules which we have determined that a which products are destined. In doing the primary purpose of which is to certain disease does not exist would be so, the Member should take into account regulate issues of human health, human classified as one of three different risk relevant geography, ecology, methods of safety, or the environment. This class levels, depending on the length of surveillance and effectiveness of control proposed rule does not fall under these time the region has been free of the systems. [NAFTA–SPS, Article 716; criteria, and consequently has not been disease, and the risk that the disease WTO–SPS, Articles 6.1–6.2] reviewed by the Office of Risk might be introduced into the region. At the same time, the agreements Assessment and Cost Benefit Analysis. Likewise, under this approach, two explicitly recognize the right of In accordance with 5 U.S.C. 603, we separate risk classifications for regions governments to take measures to protect have performed an Initial Regulatory in which a disease is known to exist human, animal, and plant health, as Flexibility Analysis regarding the would be established, as well as one long as these are based on science, are impact of this proposed rule on small additional risk class category for necessary for the protection of health, entities. This proposed action may have countries or regions that do not yet have and do not unjustifiably discriminate a significant economic impact on a specific classification as another risk among foreign sources of supply. In substantial number of small entities. class level. Therefore, under this considering this proposed rulemaking, Therefore, we are inviting comments proposed rule, regions would fall into APHIS identified and considered four concerning potential impacts. In one of six risk class levels or categories. options, keeping in mind the two goals particular, we are interested in Under this proposal, biosecurity of compliance with the international determining the number and kind of measures for the importation of animals agreements and protection of domestic products, countries, and small entities and animal products become more animal health. that may incur benefits or costs from stringent as the risk class number The first option was to retain the implementation of this proposed rule. increases, in order to protect domestic current regulatory system that bases In accordance with 21 U.S.C. 111, the agriculture from exotic animal diseases. animal and animal product import Secretary of Agriculture is authorized to The six risk categories in the proposed requirements on whether a disease is promulgate regulations to prevent the rule are described qualitatively and considered to exist or not exist introduction or dissemination of any quantitatively in terms of the expected anywhere in a country. APHIS believes contagious, infectious, or communicable range of results from quantitative risk this alternative would not be in disease of animals from a foreign assessments using scientifically compliance with NAFTA–SPS or WTO– country into the United States. This accepted methods. Decisions whether SPS, cited in the preceding paragraph. proposed rule would establish criteria an animal or animal product may be This alternative would likely lead to a for foreign ‘‘regions’’ based on risk class imported depend on the risk negative economic impact on the United levels. In this proposed rule, we define classification of the source region and States, as U.S. policies would be the term region to mean ‘‘any defined whether there exist biosecurity challenged under NAFTA and GATT, geographic land region identifiable by measures to mitigate the risk to a with reciprocal measures likely being geological, political, or surveyed negligible level. Thus, within the taken by foreign countries. boundaries.’’ Under this definition, a proposed rule, the standard for Further, we believe that the current region may be a national entity, part of imported animals and products after regulatory policy unnecessarily a national entity, combined parts of mitigation is one of negligible risk. prohibits or restricts the importation of several national entities, or a group of Economic theory would call for this animals and animal products in many several national entities combined into standard to be discovered by an explicit situations where such importation can a single trading block. The criteria for comparison of marginal benefits and be carried out with insignificant risk of Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17015 introducing disease agents into the and would be unwieldy on a working further information is needed, or will United States. For example, under the level to administer. recommend to the Administrator that current regulations, a country in which By making distinctions that can be the request be approved. If the cattle are vaccinated for FMD is not practicably made between different risk recommendation is to approve the considered to be a country in which class levels, we believe that it is request, a notice of proposed FMD does not exist, even if there have appropriate to establish more than three rulemaking will be published in the been no recently reported cases of the risk categories. APHIS believes that six Federal Register, proposing the status of disease in the country. This situation risk class levels are scientifically the region for the restricted agent in exists because vaccinated cattle could defensible for imports from other question, evaluating the relative risks, potentially become infected with the countries. Also, similar categorizations and analyzing the impacts of the FMD virus and not show any clinical could in the future justifiably be classification. Public comment will be signs. However, animals from countries considered by other countries regarding solicited on the proposed risk class in which the disease has not been exports from the United States. designation. If, after reviewing public reported, but in which vaccination is In this proposed rule, we propose comment, APHIS continues to believe carried out, do not present the same risk classifications of ‘‘regions’’ of the world the proposed risk class should be made as animals from countries in which the which consist almost exclusively of final, a final rule will be published, disease is considered to exist. We national entities (countries), to develop along with an updated evaluation of the believe that the risk from countries a baseline similar to the disease statuses risks and an updated impact analysis. which carry out vaccination can be as set forth in the current regulations. In The long-range impact of this rule reduced to a negligible level through cases where a disease is not specifically will depend on trade decisions made by mitigating measures. Under the current listed in the current regulations, the foreign importers and foreign regulations, however, the two types of baseline is based on the published governments, and on market countries are subject to the same epidemiologic information about the considerations. This concept is perhaps prohibitions. disease distribution. In all cases where the most significant policy and neither regulatory precedent nor A second alternative considered by regulatory issue facing APHIS and our adequate published epidemiologic data APHIS was to establish levels of risk, trade partners. It is expected to create existed to classify a country as either with accompanying mitigating new opportunities for the United States, Risk Class RN (negligible risk), R1, R2, measures, but to establish a fewer as well as for other countries, to export R3, or R4, we have proposed to classify not only from areas that are number of such levels than the six set the country as Risk Class RU for demonstrated to be free of particular forth in this proposed rule. While this unknown or unclassified risk. Where a diseases, but also from areas of low option would be less restrictive than the disease agent has not been reported disease or pest prevalence under ‘‘free/not-free’’ approach, we believe from a country, and there is no evidence mitigated circumstances. that it would unnecessarily group that the disease agent now exists or has As discussed above, the risk class countries and regions that have distinct ever existed in the country, we have designations in this proposed rule are levels of risk. For example, if the proposed to classify the country as Risk largely based on the country regulations were to establish the risk Class RN. It is important to note, classifications set forth in the current categories of ‘‘low risk,’’ ‘‘moderate however, that the classifications set regulations. However, based on risk,’’ and ‘‘high risk’’ for FMD, both forth in this proposed rule are subject to epidemiological evidence and other data Canada and Uruguay would be change based on information supplied available to us, and site (country) visits categorized as low risk, because the to APHIS by members of the public, or to review animal health programs, we disease does not exist in either country. by countries or other regions, that are proposing to use the proposed This would make both countries subject indicates that the region size or risk process to implement risk classification to the same requirements for the class should be changed. for two countries differently than would importation of ruminants and swine and This proposed rule sets forth be the case solely based on the current their products into the United States. procedures for requesting recognition of regulations. The rationale for these However, we believe that these an area as a region and for establishment designations is set forth in the countries present different levels of risk. of risk class designations that differ supplementary information of this A longer period of time has elapsed from those set forth in this proposal. document under the heading ‘‘Listing of since the last reported case of FMD in These procedures are set forth in § 92.5 Risk Classifications for Individual Canada than in Uruguay. Vaccination of this proposed rule. In general, they Regions.’’ We are proposing that for FMD was conducted in Uruguay provide that the official of the national Argentina be designated Risk Class R2 until relatively recently, whereas government of any country, who has the (low risk) for FMD, and the State of vaccination has not been carried out in authority in that country to request such Sonora in Mexico be designated as Risk Canada because the last reported a change, may request at any time that Class R1 for hog cholera. In the current outbreak there was in the 1950s. all or part of the country be classified or regulations, Argentina is listed as a Additionally, Uruguay shares borders, reclassified as a Risk Class RN, R1, R2, country in which FMD is considered to albeit protected ones, with countries R3, or R4 region, or be included within exist, and Mexico is listed as a country where FMD exists, whereas Canada does an adjacent previously classified region. in which hog cholera is considered to not. Under this proposal, therefore, After receiving a formal questionnaire exist. As such, the current regulations Canada is considered a region of from APHIS, the Chief Veterinary prohibit or restrict certain animal and negligible risk for FMD and Uruguay is Officer of the region must return the product imports from these countries. considered a region of slight risk. completed questionnaire to APHIS, At this time, we have conducted an Another alternative APHIS considered along with a copy of the region’s analysis for two countries, Argentina was to establish more than six risk class applicable agricultural laws and and Mexico, that could be affected in levels. However, the distinctions among regulations. This information will be the short term by the regulation change. an increased number of risk classes evaluated by a committee formed by the Although Argentina and Mexico would would be extremely difficult to identify Administrator of APHIS, which will initially be the most likely countries to consistently based on current research, either deny the request or indicate be affected by this rule as proposed, we 17016 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules are moving in the direction of cattle fed on grain. Most of the grass-fed Although the aggregate domestic multilateral regionalization with much meat production is suitable for low- producer welfare losses would appear to broader effects than implied by this quality uses in the United States. be significant, total industry sales and partial analysis. A more complete Selected cuts from grass-fed cattle could the large number of operations make the analysis is not possible now, but over possibly classify as grain-fed beef. per farm producer losses relatively time the United States will have With large present and potential beef small. Beef and dairy farms with annual additional export opportunities as well production, Argentina is likely to sales of less than $0.5 million are as import competition. increase its beef exports. With considered small according to Small Business Administration (SBA) size Imports From Argentina comparable or higher returns from chilled product (as compared with criteria. Recent Census data show that Argentina is currently considered a prepared product), trade sources suggest about 99.8 percent of operations with country in which foot-and-mouth that sufficient economic incentive and beef cows have herds with fewer than disease (FMD) exists. With such a product exists to encourage Argentina to 1,000 head.3 On average, these 801,940 designation, the importation of fresh fill (and possibly exceed) its 20,000 MT operations had sales of under $0.5 meat and meat products of ruminants tariff-rate uncooked beef quota with the million while maintaining 92.9 percent and swine from Argentina is prohibited. U.S. through increased production and/ of beef cow inventories. Farms with less Under this rule, however, fresh meat or diversion of current exports. than $0.5 million of cattle and calves from ruminants and swine could be Impact on U.S. Consumers: Assuming sales averaged sales of $20,976 in 1992, imported from Argentina, because it Argentina fills its 20,000 MT beef tariff- as opposed to average sales of $1.3 would be classified as Risk Class R2 rate quota limit in the U.S.’s uncooked million on larger farms. Similarly for (low risk) for FMD, because it has a beef market with grass-fed beef, dairy operations, most producers fall in maximum herd incidence of a restricted consumer welfare gains of $90 million the ‘‘small’’ business category. Recent disease at less than 0.1 percent and has annually are possible. Grass-fed beef is USDA data show that 95.6 percent of effective border control between other used mainly in ‘‘non-table-cut’’ beef operations with milk cows have fewer countries. If this rule is adopted, we applications, such as in hamburger meat than 200 head in their herds. Census expect Argentina to export up to 20,000 patties, sausages, and other prepared data is available on farms with dairy metric tons of fresh meat to the United meals and foods. This analysis assumes product sales, but not by herd size. States. These data show that 95.2 percent of The changes in the regulations would that 22 percent of U.S. beef consumption goes into such non-table- these farms have sales of less than $0.5 be expected to mainly affect bovine million. Assuming that both data are meat and meat products (beef). Other cut applications while 78 percent goes into consumer applications, such as tracking roughly the same dairy livestock sectors that would be expected operations, we can deduce that 68.2 to be marginally affected are: swine, table cut use at home and away-from- home eating that utilizes beef made percent of milk cow inventories are on dairy, and the mutton/lamb/goat the 152,500 operations with sales of less complex. from grain-fed beef. Grain-fed beef production dominates U.S. domestic than $0.5 million and average dairy Analysis beef production (87 percent). Thus, product sales of less than $93,800 per farm in 1992. Besides the sale of dairy imports consisting of grass-fed beef Beef: The proposed regulation products, the sale of cull dairy cattle affect consumer prices more than changes would relax the FMD- and and young stock (not selected to be domestic producer prices because of rinderpest-related restrictions imposed retained for milking or breeding grass-fed beef’s higher quantity weight on the importation of live cattle, bovine purposes) contribute to farm income. in consumption compared to meat and prepared products from USDA budget data for 1992 indicated production. When imports are assumed Argentina. This rule change would be that, on an average U.S. dairy operation, to consist mainly of grass-fed beef, expected to substantially alter beef the sale of culled cattle contributed consumers stand to gain almost $90 imports from Argentina, since the $1.27 (around 8 percent) for every million as average retail beef prices drop United States has had restrictions on $15.85 of receipts. Census data indicate by $8.27 per MT carcass weight uncooked beef imports from Argentina that cattle sales contribute about $8,000 equivalent (CWE). since the 1930 Tariff Act. However, this toward gross farm sales on a small dairy Impact on U.S. Livestock Sector: analysis assumes that Argentine farm (total sales average about Primary producers of livestock and beef uncooked beef exports to the U.S. would $102,000), also about 8 percent of total products would be detrimentally not exceed their 20,000 MT tariff-rate gross farm income. quota limit. Future economic impact on affected by increased beef imports. The Maximum per farm drops in producer U.S. beef producers would depend on magnitude and the type of beef gross sales would be expected to range demand-side factors, such as consumer imported would determine the size and from $15 to $35 for cow-calf beef acceptance of Argentine product, but distribution of domestic producer operators. In either case, gross farm also on whether the uncooked beef welfare loss across the farm and income would drop less than one-sixth imports consist mainly of grass-fed beef secondary production levels. When of one percent. Expected maximum per as expected, and whether Argentina imports are assumed to consist mainly farm percentage drops in dairy producer reaches or exceeds 20,000 MT’s of of grass-fed beef, domestic producer gross sales would be even lower than uncooked beef shipments to the U.S. welfare throughout the system is those for cow-calf beef operators. Recent speculation is that Argentina lowered by an estimated $41 million Impact on Feedlot Operators: No would most likely start with grass-fed ($3.84/MT CWE). quantity effect would be registered if beef product and attempt, over time, to Imports of Argentine, uncooked, imports consist of grass-fed beef. With produce product that would be suitable grass-fed beef would be expected to increased imports of grass-fed beef, the for the U.S. grain-fed beef market. dampen demand for low-quality beef increased market beef supplies would Argentine beef production is made up (made from both culled beef and dairy be expected to displace low-quality of mostly grass fed product. These cows), and force some of the domestic animals take longer to reach slaughter producer losses to be shared by both the 3 Source: 1992 US Census, Beef Cow Herd Size by weights and are lighter at slaughter than U.S. dairy and beef sectors. Inventory and Sales: 1992, Table 28, pg. 30. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17017 beef, mainly affecting dairy and beef Argentina during this period rose from 1. The production of live hogs in cow-calf operations and indirectly 1,363 MT to 25,392 MT, while exports Sonora would be maintained at the affecting feedlots by reducing the declined from 2,755 MT to 67 MT. current 1.5 million head level; number of cattle available to be placed Dairy: With regards to the sale of 2. Twenty percent of total production on feed. This increased culling of dairy dairy products, we do not anticipate a would continue to be shipped out of the and beef cows would reduce the supply major increase in exports of milk and region live for slaughter and processing of beef calves and raise the prices for milk products from Argentina into the (currently most of these shipments go to both yearlings and grain-fed cattle. United States as a result of this Mexico City, some 1,500 miles away). Gains from output price increases (on proposed rule. Only about 5 percent of The Los Angeles, California area is only grain-fed cattle) would be offset by Argentina’s cow herd is made up of 500 miles away and is currently receiving live slaughter hogs from other losses incurred by price increases on dairy cows, and it is expected that the 4 parts of the U.S., including the U.S. purchased calves. The net per head loss increase in beef cattle returns will not Midwest, making it a potentially would be $0.24. Such small losses significantly alter this situation. In attractive demand site for live slaughter would not be expected to substantially addition, all dairy products imported change production. The potential hog shipments from Sonora; into the United States are restricted by 3. The remaining 80 percent of aggregate domestic feedlot operators’ quotas except for casein, caseinate, and producer welfare loss is estimated at production would be processed in other casein derivatives (hereafter Sonora with about 15 percent going as $5.4 million with increased imports of referred to as casein), which are dry grass-fed beef. This aggregate loss is specialized pork cuts to Japan; the milk products. The United States does expected to translate into less than a $30 remaining 85 percent would be not produce casein. Argentina has not per year drop in gross sales on an available for use in Mexico or shipment exported casein to the United States in average ‘‘small’’ feedlot (about a 0.03 to the U.S.; recent years, and this proposed rule percent drop). 4. Current hog feeders in Mexico Impact on Live Cattle Dealers/ would be expected to have minimal if would be able to hedge on currency and Transporters: Close estimation of the any effect on the amount of casein commodity markets, so as to minimize impact on this sub-sector is not possible imported into the United States. short-run financial risk of exchange rate given the available data. Because census Miscellaneous. The United States has and feed price fluctuations. These data on transporters is in a general not imported any mutton, lamb, or goat instruments are not capable of shielding category with other agricultural product meat from Argentina in the past 2 years. long-lasting currency devaluations, such shipments, it is unclear how important This situation would not be expected to as what has recently occurred in cattle transportation is to a particular change as a result of this proposed rule. Mexico. Operations which require large ‘‘small’’ firm’s business. Additional data Miscellaneous animal products from amounts of imported feeds, such as hog are also needed on average miles Argentina, including embryos, semen, feeding operations that rely on U.S. traveled and net returns per trip. breeding animals, and other products, feedstuffs—bought with Mexican However, it appears that there would be are already allowed importation into the currency—are probably experiencing a negligible reduction in transporter United States under certain restrictions. considerable financial difficulties. Such trips needed due to this proposed rule— This proposed rule would lessen the pressure, in the short term, may lead to ranging from negligible if potential restrictions on the importation of these cutbacks in Mexican production and/or imports are assumed to be grass-fed products. We welcome information from trade from Mexico to the U.S. However, beef, to less than 1,500 if potential the public regarding any potential such devaluations would assist in the imports are assumed to be grain-fed impact this lessening of restrictions export of finished products from beef. A negligible increase in transport might have. Mexico, such as live swine and processed pork products. Also, in the of imported meat and meat products Imports From Mexico from ports of arrival would be expected. longer run, some appreciation of the Impact on Cattle Slaughterers/ It appears that the State of Sonora, Mexican peso is expected. Uncertainty Primary Processors: As in the case with Mexico would meet all the criteria in as to when and what extent such cattle dealers/transporters, the reduction proposed § 92.3 to be classified as a Risk appreciation will occur leads to the in cattle marketings would be expected Class R1 region for hog cholera. The following assumption: The influence on to be very small in relation to current changes in the regulations would be Mexican production and trade due to marketings. With increased beef imports expected to primarily affect feeder pigs, exchange rate fluctuation is assumed to consisting of grass-fed beef, slaughterers slaughter hogs, and pork products. No be neutral in this analysis; 5. 1994 US marketings of 95.697 would receive virtually the same other livestock sectors are expected to million head of slaughter hogs at the number of marketings, but enjoy lower be affected by the proposed average price of $40.03 per CWT priced culled beef and dairy cows while classification of Sonora. facing lower wholesale prices for their liveweight are used as the U.S. base output. On average, the losses from Analysis year; lower retail grass-fed beef prices would 6. A low-impact scenario is The regulation changes would relax constructed consisting of 75,000 live be expected to almost equal the gains the hog cholera-related restrictions from price drops on purchased culled hogs and 18.6 million pounds carcass imposed on the importation of live weight equivalent (CWE) of pork cows. swine and prepared pork products from Swine: No significant impacts because products. This assumes that one-quarter Sonora, Mexico. This rule change could of Argentine swine production and of current live slaughter hog shipments significantly alter current swine imports trade would be expected as a result of out of Sonora is diverted to the from Mexico. Based on various this proposed rule. Argentine swine Southwest (mostly to Los Angeles), as assumptions, some combination of production has declined considerably well as about 10 percent of the Mexican live swine and/pork exports to since the early 1990s. Pork imports into processed pork production of Sonora. the U.S. would be expected to take Imported swine and pork are assumed place. 4 Yearling prices go up more per head ($0.64 per to substitute perfectly for U.S. product head) than for fed cattle ($0.40 per head). Important assumptions are: and displace it; 17018 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

7. A high-impact scenario is Impact on U.S. Consumers: Assuming declining farm numbers (but almost constructed consisting of 300,000 live Mexico swine producers find it in their stable production) and persistent hogs and 92.9 million pounds carcass interest to ship swine and/or pork competitive pressure on producers to weight equivalent (CWE) of pork products to the U.S., consumer welfare adopt least-cost production methods to products. This assumes that all of gains of $28 million (low-impact the extent available. Dividing the current live hog shipments out of scenario) to $150 million (high-impact adjusted aggregate economic impact Sonora is diverted to the Southwest as scenario) annually would be possible generated under the two scenarios listed well as about 50 percent of the depending on the volume and above (low- and high-impact scenarios) processed pork production of Sonora. composition of imports from Mexico. by the number of small swine Again, imported swine and pork are Impact on U.S. Livestock Sector: operations results in a potential loss in assumed to perfectly substitute for U.S. Primary producers of livestock and net annual farm income of almost $154 product and displace it. swine products would be detrimentally and $808, respectively. Future economic impact on U.S. affected whether live slaughter hogs or Impact on Live Hog Dealers/ swine producers will depend on pork product imports increase. When Transporters: Reductions in the number demand-side factors, such as consumer imports are assumed to be in the low- of hogs produced in the United States as acceptance of Mexican product, but impact range, producer welfare a result of imports under either the low- probably most heavily on two supply- throughout the system would be or high-impact scenario would be side factors—increases in total Mexican lowered by an estimated $28 million expected to be minimal—225 and 1,035 production and the composition of ($0.13/CWT CWE) as opposed to $149 less trips, respectively. The impact of product shipped from Mexico. This million ($0.66/CWT CWE) when the worst case scenario represents less supply effect will be heavily affected by imports are assumed to be in the high- than .2 percent of total hauls of US hog the long-term exchange rate between the impact scenario. A further break-down shipments in 1994. U.S. and Mexico. Composition of of the potential impact on the U.S. Most firms in this industry are product will affect producer and livestock sector follows: considered ‘‘small’’ according to SBA consumer effects as follows: Impact on Farrow-to-Finish Swine guidelines (i.e., sales of less than $12.5 Operators: Imports in the low-impact million and fewer than 500 employees). 1. If the weight of increased imports scenario are assumed to represent about Firms in this industry are assumed to be are in the form of feeder pigs, adverse 178,200 hogs per year in a combination classified in the general Census economic impacts would be localized of live slaughter hogs and pork product category, motor freight transportation on feeder pig producers, not feed grain imports. Barrow and gilt slaughter hog and warehousing (SIC 4212 and SIC producers or slaughters/processors. prices would decrease by about 15 cents 4213) with over 10,600 firms in 1992. Increased feed pig shipments could be per CWT. This lower price would elicit SIC 4212 pt. (other local trucking, particularly important in times of high a cut in total U.S. hog production of without storage, of agricultural feed costs in Mexico, such as occurs at about 45,000 hogs per year. The lower products) contained 6,203 times in the U.S. Southeast. production level at a slightly lower establishments with $2.197 billion in 2. Live slaughter hog imports would price would reduce producer receipts by revenue in 1992 and employed 26,897 be expected to directly displace U.S. about $28 million per year. employees. The average firm revenue produced hogs. For every four hogs or When imports are assumed to fall in was $354,183, with employment of 4 to hog equivalents imported, one U.S. hog the high impact scenario, increased 5 workers. Thus, the average firm in the would be expected to be displaced and imports would be expected to represent industry would fall under the SBA its economic contribution to slaughter up to 816,000 hogs per year in a category of ‘‘small’’ with sales of less and processing lost. Feed grain combination of live slaughter hog and than $12.5 million and less than 500 producers would experience some loss pork product imports. Barrow and gilt employees. SIC 4213 pt. (trucking, if Mexican producers do not rely on slaughter hog prices would be expected except local, of agricultural products) U.S. grain. However, it is possible that to decrease by about 66 cents per CWT. contained 4,483 establishments with a greater amount of U.S. feed would be This lower price would elicit a cut in $3.3 billion in revenue in 1992 and used if some amount of Mexican pork/ total US hog production of about employed 30,518 employees. The swine is imported, given that Mexican 200,000 hogs per year. This lower average firm revenue was $736,114, hog producers use U.S. feedgrains. production level, along with a lower with employment of 6 to 7 workers. Activity at the slaughter/processor level price, would reduce producer receipts Thus, the average firm in the industry would be increased with Mexican live by about $149 million per year. would fall under the SBA category of hog slaughter imports. Although the aggregate potential ‘‘small,’’ with sales of less than $12.5 3. The impact of pork product imports producer welfare losses appear million and less than 500 employees. is difficult to forecast because of the significant, total industry sales and the More detailed data on the actual uncertainty as to how they would large number of operations would make distribution of firms by size are not substitute for foreign and/or domestic the per-farm producer losses relatively available at this time. product. For example, certain Mexican small. In 1992, there were about 191,347 Estimation of the potential impact on pork imports might not affect U.S. hog and pig farms in the United States, this sub-sector is not possible given the producers at all. These imports might of which it is estimated that about 96.4 available data. Census data on not substitute for a U.S.-produced pork percent would be considered ‘‘small’’ transporters is in a general category with product, or they might completely entities (annual sales of less than $0.5 other agricultural product shipments, substitute for and displace a similar million, according to Small Business thus it is unclear how important pork product currently imported from Administration (SBA) size criteria). livestock transportation is to a particular another country. In those cases where Total value of hog inventories on ‘‘small’’ firm’s business. Additional data Mexican pork products would displace December 1992 exceeded $4,146.6 are also needed concerning average U.S. product, U.S. prices would million, producing $9.9 billion in sales. miles traveled and net returns per trip. decrease, U.S. production would The small hog and pig entities maintain The relatively small reductions in trips decrease, and activity at the slaughter/ over 70 percent of these hog and pig needed suggest that the economic processor level would drop. inventories. Historical U.S. data show impact on this sub-sector would Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17019 probably be very small. Further, if we Paperwork Reduction Act Estimate of burden: Public reporting assume that these reductions would be In accordance with section 3507(d) of burden for this collection of information expected to fall evenly across all firms, the Paperwork Reduction Act of 1995 is estimated to average 7 hours and 4.5 this reduced level of economic activity (44 U.S.C. 3501 et seq.), the information minutes per response for animal is not expected to drive any small collection or recordkeeping importations and 27 minutes per livestock dealers/transporters out of requirements included in this proposed response for animal product business. Some increase in transport of rule have been submitted for approval to importations. swine or pork products from ports of the Office of Management and Budget Respondents: Importers and arrival would be expected. (OMB). Please send written comments veterinarians. Estimated number of respondents (for Impact on Swine Slaughterers/ to the Office of Information and animal importations): 208,065 total Primary Processors: As was the case Regulatory Affairs, OMB, Attention: (30,030 of which would be new with livestock dealers/transporters, the Desk Officer for APHIS, Washington, DC respondents as a result of our reduction in swine marketings would be 20503. Please state that your comments rulemaking). very small in relation to current refer to Docket No. 94–106–1. Please Estimated number of respondents (for marketings. However, it should be kept send a copy of your comments to: (1) animal product importations): 8,955 in mind that hog slaughterers and Docket No. 94–106–1, Regulatory total (1,829 of which would be new processors would benefit if imports Analysis and Development, PPD, respondents as a result of our consist of higher proportions of live APHIS, Suite 3C03, 4700 River Road hogs relative to processed pork. Under rulemaking). Unit 118. Riverdale, MD 20737–1228, Estimated number of responses per the two scenarios considered, increased and (2) Clearance Officer, OIRM, USDA, slaughter (brought about by increased respondent (for animal importations): room 404–W, 14th Street and 8.158. slaughter hog imports) would more than Independence Avenue SW., offset production losses from processed Estimated number of responses per Washington, DC 20250. A comment to respondent (for animal product pork product imports. In the low-impact OMB is best assured of having its full scenario, processors would realize a net importations): 11.64. effect if OMB receives it within 30 days Estimated total annual burden on increase of 30,000 slaughter hogs. Under of publication of the proposed rule. the high-impact scenario, an increase of respondents (for animal importations): This proposed rule contains 241,067 hours (178,684 of which would 93,000 slaughter hogs appears possible. paperwork and recordkeeping The size distribution of firms in this be new hours due to our rulemaking). requirements. Under this proposed rule, sub-sector makes it difficult to allocate Estimated total annual burden on officials in foreign countries that wish to the small benefits estimated above respondents (for animal product have a region recognized and classified across large and small firms. In the past, importations): 47,080 hours (15,926 of by APHIS would be required to submit the desire to reduce transportation costs which would be new hours due to our an application, along with data of cattle and product, to gain economies rulemaking). supporting their request for a specific of scale in plant operations, and to shift Copies of this information collection classification. This rule would to newer plants (without existing labor can be obtained from: Clearance Officer, necessitate the introduction of various contracts) has lead to increased industry OIRM, USDA, room 404–W, 14th Street information collection requirements to concentration in this U.S. sub-sector. and Independence Avenue SW., enable us to monitor accurately the The exit of many older, smaller plants Washington, DC 20250. health status of regions and the and companies have also contributed to movement of animals and animal National Environmental Policy Act increased market concentration. Most products from those regions into the This proposed rule raises some issues firms have multi-million dollar United States. We are soliciting that could include potential operations made up of new, large, state- comments from the public (as well as environmental impacts. Such issues are of-the-art slaughter and packing plants. affected agencies) concerning our being examined by APHIS in the context In 1992, there were 1,385 meat packing proposed information collection and of an environmental assessment (EA). establishments in the U.S. down from recordkeeping requirements. We need We invite comments from the public on 1,434 such establishments in 1987.5 The this outside input to help us accomplish this proposed rule, including those 1987 data indicate that 88 pork- the following: regarding potential environmental slaughter companies had more than 20 (1) Evaluate whether the proposed impacts. Prior to, or in conjunction employees. These companies had a total information collection is necessary for with, a final rule, APHIS will issue an of 34,300 employees, with a payroll of the proper performance of our agency’s EA addressing such issues in $713.8 million and shipments of pork functions, including whether the accordance with: (1) The National valued at $11.6 billion. information will have practical utility; Environmental Policy Act (NEPA) (42 Executive Order 12778 (2) Evaluate the accuracy of our U.S.C. 4321 et seq.), (2) Regulations of This proposed rule has been reviewed estimate of the burden of the proposed the Council on Environmental Quality under Executive Order 12778, Civil information collection, including the for Implementing the Procedural Justice Reform. If this proposed rule is methodology and assumptions used; Provisions of NEPA (40 CFR parts 1500– adopted: (1) All State and local laws and (3) Enhance the quality, utility, and 1508), (3) USDA Regulations regulations that are inconsistent with clarity of the information to be Implementing NEPA (7 CFR part 1b), this rule will be preempted; (2) no collected; and and (4) APHIS’ NEPA Implementing (4) Minimize the burden of the retroactive effect will be given to this Procedures (7 CFR part 372). information collection on those who are rule; and (3) administrative proceedings to respond (such as through the use of Unfunded Mandate Reform Act of 1995 will not be required before parties may appropriate automated, electronic, Title II of the Unfunded Mandates file suit in court challenging this rule. mechanical, or other technological Reform Act of 1995 (UMRA), Pub. L. 5 Source: 1992 Census of Manufacturers, MC92– collection techniques or other forms of 104–4, establishes requirements for SUM–1(P), Preliminary Report, Summary Series, information technology, e.g., permitting Federal agencies to assess the effects of pg. 9. electronic submission responses). their regulatory actions on State, local, 17020 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules and tribal governments and the private PARTS 92 AND 93Ð[AMENDED] expected to be infected, infested, or sector. Under section 202 of the UMRA, exposed to a communicable disease APHIS generally must prepare a written §§ 93.1±93.8 [Redesignated as §§ 92.800± agent. statement, including a cost-benefit 92.807] Affected premises or region. A analysis, for proposed and final rules 1. Part 93 would be amended by premises or region where a with ‘‘Federal mandates’’ that may removing the heading and the authority communicable disease agent is known result in expenditures to State, local, or citation and by redesignating §§ 93.1 to exist; that is adjacent to or proximate tribal governments, in the aggregate, or through 93.8 as §§ 92.800 through to any known infected or infested to the private sector, of $100 million or 92.807, and adding a subpart heading premises or region so that airborne, more in any one year. When such a before these sections to read: ‘‘Subpart vector, or mechanical transmission of statement is needed for a rule, section H—Elephants, Hippopotami, the disease agent could occur; or that, 205 of the UMRA generally requires Rhinoceroses, and Tapirs’’. because of lack of surveillance data, APHIS to identify and consider a could reasonably be expected to be PART 92Ð[REDESIGNATED AS PART reasonable number of regulatory infected, infested, or exposed to a 93] alternatives and adopt the least costly, communicable disease agent. more cost-effective or least burdensome 2. Part 92 would be redesignated as Africa. The continent of Africa alternative that achieves the objectives part 93. including the countries of: Algeria, of the rule. 3. A new part 92 would be added to Angola, Benin, Botswana, Burkina Faso, This proposed rule contains no read as follows: Burundi, Cameroon, Cent. African Rep., Federal mandates (under the regulatory Chad, Comoros, Congo, Djibouti, Egypt, PART 92ÐRESTRICTED AGENTS AND provisions of Title II of the UMRA) that Equatorial Guinea, Ethiopia, Gabon, VECTORS, AND CRITERIA FOR may result in expenditures to State Ghana, Guinea, Guinea-Bissau, Ivory REGIONAL RISK CLASSIFICATION local, and tribal governments, in the Coast, Kenya, Lesotho, Liberia, Libya, Madagascar, Malawi, Mali, Mauritania, aggregate, or to the private sector, of Sec. $100 million or more in any one year. 92.1 Definitions. Morocco, Mozambique, Namibia, Niger, Thus, this proposed rule is not subject 92.2 Restricted agents and vectors. Nigeria, Rwanda, Sao Tome and Princip, to the requirements of sections 202 and 92.3 Criteria for risk classification. Senegal, Sierra Leone, Somalia, South 205 of the UMRA. 92.4 Risk classification by region and Africa, Sudan, Swaziland, Tanzania, restricted disease agent. The Gambia, Togo, Tunisia, Uganda, List of Subjects 92.5 Application for recognition of Risk Western Sahara, Zaire, Zambia, Class RN, R1, R2, R3, or R4. 9 CFR Part 92 Zimbabwe. Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; Animal and Plant Health Inspection Animal diseases, Imports, Livestock, 21 U.S.C. 102–105, 111, 114a, 134a, 134b, Service (APHIS). The Animal and Plant 134c, 134d, 134f, 135, 136, and 136a; 31 Health Inspection Service of the United Poultry and poultry products, U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.2(d). Quarantine, Reporting and States Department of Agriculture. recordkeeping requirements. § 92.1 Definitions. Animals. All species of the animal kingdom including: Cattle, sheep, goats, 9 CFR Part 93 Wherever in this subpart the following terms are used, unless the other ruminants, swine, horses, asses, Animal diseases, Imports, Reporting context otherwise requires, they shall be mules, zebras, dogs, and poultry that are and recordkeeping requirements. construed, respectively, to mean: susceptible to communicable diseases of Active surveillance. Sample collection livestock or capable of being carriers of 9 CFR Part 94 using a systematic or statistically those diseases or their arthropod designed survey methodology to vectors. Animal diseases, Imports, Livestock, actively seek out and find cases of APHIS representative. Any individual Meat and meat products, Milk, Poultry animals with a disease agent, or to employed by the Animal and Plant and poultry products, Reporting and determine the prevalence of the disease Health Inspection Service, United States recordkeeping requirements. agent in the population. Department of Agriculture, who is 9 CFR Part 95 Adjacent region. Any defined authorized to perform the services geographic land area identifiable by required by this part. Animal feeds, Hay, Imports, geological, political or surveyed Asia. Part of the continent of Asia, Livestock, Reporting and recordkeeping boundaries that shares common including the countries of: Afghanistan, requirements, Straw, Transportation. boundaries with, or is proximate to any Armenia, Azerbaijan, Bangladesh, Bhutan, Burma, Cambodia, China, 9 CFR Part 96 region of a different risk class, as determined by the Administrator. Georgia, Hong Kong, India, Iran, Japan, Imports, Livestock, Reporting and Administrator. The Administrator of Kazakhstan, Kygyzstan, Laos, Macau, recordkeeping requirements. the Animal and Plant Health Inspection Malaysia, Mongolia, Nepal, North Service or any other employee of the Korea, Pakistan, Russia, Singapore, 9 CFR Part 98 Animal and Plant Health Inspection South Korea, , Taiwan, Tajikistak, Thailand, Turkistan, Animal diseases, Imports. Service, United States Department of Agriculture, delegated to act in the Uzbekistan, Vietnam. Accordingly, under the authority Administrator’s stead. Atlantic. Island countries located in provided in 7 U.S.C. 147a, 150ee, 161, Affected animals. Animals currently the Atlantic Ocean including: Bermuda, 162, 450, 1622; 19 U.S.C. 1306; 21 infected or infested with, or exposed to, Cape Verde, Falkland Islands, South U.S.C. 102–105, 111, 114a, 134a, 134b, a communicable disease agent, or that Georgia. 134c, 134d, 134f, 135, 136, 136a; 31 are not known to be infected, infested, Australia. The continent of Australia U.S.C. 9701; 42 U.S.C. 4331, and 4332, or exposed but that because of, including the country of Australia. we propose to amend 9 CFR chapter I, proximity, location, season, or lack of Border definitions. subchapter D, as follows: surveillance data could reasonably be (1) Natural physical barriers: Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17021

(i) Rivers, lakes or oceans with all (2) For premises or regions, having on or more parts of a single premises (farm, crossing points such as bridges, ferries, or within the premises or region, ranch, feedlot, etc.); or or ports identified as controlled entry animals, feed, water, air, soil, tools or (2) A group of animals under common points; other objects, insects, or ectoparasites ownership or supervision maintained (ii) Mountains with all crossing points infected or contaminated with a on geographically separated premises, (passes, etc.) identified as officially communicable disease agent. but that have been interchanged controlled entry points. Contagious disease. Any between the different premises or have (2) Man-made physical barriers. communicable disease transmitted from been otherwise intermingled. Constructed fences, walls, moats, etc., one animal to another by direct contact Herd incidence rate. The proportion that prevent animals from straying or or by feed, water, aerosol, or of herds, flocks or other groups of being transported, trailed, or driven contaminated objects. animals affected with a communicable across the borders except at officially Driven. Moved (animals) from one disease within a specified period of time controlled entry points. place to another by walking under their (usually 1 year). A herd, flock, or other (3) Protected borders: Border areas own power and being herded and group of animals would be counted only that are identifiable geo-political guided by persons or trained animals. once during the specified time period boundaries between adjacent geographic Ectoparasites. Acarid (, ticks) or regardless of the number of cases that regions. Protected border areas may be insect members of the Phylum may occur in the group of animals separated by man-made physical Arthropoda that spend all or part of during the time period. barriers with all gates or crossings their life cycle on the exterior of avian, Import (imported, importation) into identified as officially controlled entry reptilian or mammalian hosts, and that the United States. To bring into the points. Animals shall cross only at are known or suspected to be vectors of territorial limits of the United States. officially controlled entry points. communicable disease agents or are the Livestock. Domesticated species of (4) Uncontrolled borders: Animals cause of disease or irritation to animals cattle, swine, sheep, goats, llamas, or may cross unchecked at any point along or birds. horses that normally and historically the border. Europe. The continent of Europe have been kept and raised on farms. (5) Officially controlled entry points: including the countries of: Albania, ‘‘Livestock’’ also includes bison, Land border check stations, airports, Andorra, Austria, Belgium, Bosnia- cervidae, and other species kept in ship ports or other points of entry where Herzogovania, Bulgaria, Bylorus, captivity for production of food or fiber, animals or animal products may enter a Croatia, Czech Republic, Denmark, or other commercial purposes. region from any other region, but at Estonia, Finland, France, Germany, Middle America. Part of the continent which animals and animal products are Gibraltar, Greece, Greenland, Hungary, of North America including the barred from entry at all times that the Iceland, Ireland, Italy, Latvia, countries of: Belize, Costa Rica, El entry points are not staffed. Liechtenstein, Lithuania, Luxembourg, Salvador, Guatemala, Honduras, Caribbean. The islands of the Macedonia, Moldavia, Monaco, Nicaragua, Panama. Caribbean Sea and nearby areas in the Netherlands, Norway, Poland, Portugal, Middle East. Parts of the continent of Atlantic Ocean including the countries Romania, San Marino, Slovakia, Asia and islands of the Mediterranean and territories of: Anguilla, Aruba, Slovenia, Spain, Sweden, Switzerland, Sea, including the countries of: Bahrain, Barbados, British Virgin Islands, Ukraine, United Kingdom (England, Cyprus, Iraq, Israel, Jordan, Kuwait, Cayman Islands, Cuba, Dominica, Scotland, Wales, Northern Ireland, Lebanon, Malta, North Yemen, Oman, Dominican Republic, Grenada, Channel Islands, Isle of Man), Vatican Palestine, Qatar, Saudi Arabia, South Guadeloupe, Haiti, Jamaica, Martinique, City, Yugoslavia. Yemen, Syria, Turkey, United Arab Montserrat, Netherlands Antilles, Puerto Exposed. (1) An animal or means of Emirates. Rico, Saint Lucia, Saint Vincent, The conveyance that has been in contact Moved directly. Moved (shipped, Bahamas, The Bahamas, Trinidad and with or that can reasonably be expected transported, or otherwise moved) Tobago, Turks and Caicos, U.S. Virgin to have been in contact with an animal, without unloading and without Islands. feed, water, air, soil, tools, or other stopping except for refueling, or for Case. An individual animal affected objects, insects, or ectoparasites infected traffic conditions such as traffic lights or by a communicable disease agent. or contaminated with a communicable stop signs. Depending on the condition, this may disease agent, as determined by the New Zealand. The islands that be an animal with clinical signs, or an Administrator. comprise the country of New Zealand. animal with serological or pathological (2) A region or premises where an North America. Part of the continent evidence of infection, or an infested animal, feed, water, air, soil, tools or of North America including the animal. other objects, insects, or ectoparasites countries of Canada, Mexico, United Cattle. Animals of the bovine species. contaminated with a communicable States. Communicable disease. Any disease agent are or have been present. Oceania. Islands of the Pacific and contagious or infectious disease of (i) Direct exposure. Exposure by Indian Oceans including the countries animals. It can be transmitted either coming into direct contact with an of: Brunei, Fiji, French Polynesia, directly or indirectly to a susceptible infected animal, or with feed, water, air, Indonesia, Kiribati, Maldives, Mauritius, animal from an infected animal, vector, soil, tools, or other objects that have Nauru, New Caledonia, Papua New inanimate source, or other sources. been contaminated by discharges from Guinea, Philippines, Seychelles, Contact. (1) For animals, being in the an infected animal. Solomon Islands, Tonga, Vanuatu, same pen, pasture or means of (ii) Indirect exposure. Exposure by Western Samoa. conveyance with animals affected with coming into contact with vector insects Passive surveillance. A surveillance a communicable disease, or being or ectoparasites, or objects that have system that does not depend on active located in pens, pastures, or means of been contaminated other than by participation by the responsible agency conveyance that are adjacent to, adjoin discharge from an infected animal. to seek out and monitor a restricted or otherwise come into contact with Herd. (1) A group of animals under disease agent. The system relies on those containing animals affected with a common ownership or supervision that mandatory reporting, a pool of trained communicable disease. are maintained and intermingle on one investigators, diagnostic submission 17022 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules procedures and laboratory support, and Class RN region is less than 10¥6 per their own power, and by leading them periodic public information and live animal. by ropes or other devices tied to the continuing education programs on (2) Risk Class R1 Region (Slight Risk). animal and guided by persons or trained diseases. A Risk Class R1 region is not known to animals. Person. Any individual, corporation, be affected with a restricted agent. The Transported. Moved or shipped from company, association, firm, partnership, probability in a Quantitative Risk one place to another by means of society, joint stock company, or other Assessment of the introduction of a aircraft, truck, train, cart, or other means legal entity. restricted agent through an unrestricted of conveyance. Provisional quarantine. Restrictions importation from a Risk Class R1 region United States. All of the States of the placed on movements of vaccinated is less than 10¥5 per live animal. United States, the District of Columbia, livestock where the restricted agent in (3) Risk Class R2 Region (Low Risk). Guam, the Northern Mariana Islands, question is not known to exist, but the A Risk Class R2 region is not known to Puerto Rico, the Virgin Islands of the livestock may be exposed. Limited be affected with a restricted agent. The United States, and all other Territories movement may be allowed from such a probability in a Quantitative Risk and Possessions of the United States. premises for livestock to go directly to Assessment of the introduction of a Vector-borne disease. A disease slaughter or to a slaughter animal restricted agent through an unrestricted transmitted to an animal through an assembly point, or, in the case of importation from a Risk Class R2 region intermediate arthropod vector, vaccinated livestock not known to be is less than 10¥4 per live animal. including ticks or insects. affected, the animals may be moved to (4) Risk Class R3 Region (Moderate affected regions or regions that permit Risk). A Risk Class R3 region is § 92.2 Restricted agents and vectors. vaccination. currently known to be affected with a (a) Restricted contagious disease Quarantine. Confinement of all restricted agent. The probability in a agents that affect livestock or poultry susceptible animals, animal products, Quantitative Risk Assessment of the and that are not known to exist in the feed, farm machinery, other equipment, introduction of a restricted agent United States. means of conveyance, and any other through an unrestricted importation African swine fever virus potentially contaminated objects to a from a Risk Class R3 region is less than Bovine spongiform encephalopathy (BSE) premises or region where infection with 10¥3 per live animal. agent a specific restricted agent has been (5) Risk Class R4 Region (High Risk). Brucella melitensis found or is suspected to exist. A Risk Class R4 region is currently Contagious agalactia of sheep and goats Region. Any defined geographic land known to be affected with a restricted (Mycoplasma agalactiae) region identifiable by geological, agent. The probability in a Quantitative Contagious bovine pleuropneumonia (Mycoplasma mycoides subsp. mycoides) political or surveyed boundaries. A Risk Assessment of the introduction of Contagious caprine pleuropneumonia region may consist of any of the a restricted agent through an (Mycoplasma mycoides subsp. capri) following: unrestricted importation from a Risk Foot-and-mouth disease virus (1) A national entity (country); Class R4 region is less than 10¥2 per Goat pox virus (2) Part of a national entity (premises, live animal. Hog Cholera (Classical swine fever) virus zone, County, Department, (6) Risk Class RU Region (Unknown Malignant catarrhal fever virus (African or Municipality, Parish, Province, State, Risk). A Risk Class RU region is an Wildebeest form) etc.); unclassified region that, due to lack of Peste des petits ruminants (Kata) virus (3) Parts of several national entities reliable information or other reasons, Pseudomonas pseudomallei (melioidosis) combined into a region; or does not meet the requirements of any Rinderpest virus Sheep pox virus (4) A group of national entities of the above classifications. The (countries) combined into a single Swine vesicular disease virus probability in a Quantitative Risk Teschen disease virus trading block. Assessment of the introduction of a Vesicular Stomatitis virus Restricted agent. A livestock restricted agent through an unrestricted communicable disease agent, vector, or importation is greater than 10¥2 per live (b) Restricted contagious disease host of an agent, not known to exist in animal or unknown. agents that affect livestock and that the United States or that is subject to a Ruminants. All animals that chew the exist in the United States, but that are Federal or cooperative Federal/State cud, such as cattle, buffaloes, sheep, subject to cooperative Federal/State control or eradication program within goats, deer, antelopes, camels, llamas control or eradication programs: the United States. and giraffes. Brucella abortus (brucellosis or Bangs Risk Class regions. Exporting regions South America. The continent of disease) designated by the Administrator South America including the countries Brucella suis according to the results of qualitative or of: Argentina, Bolivia, Brazil, Chile, Mycobacterium bovis (bovine tuberculosis) quantitative risk assessment criteria, as Colombia, Ecuador, French Guiana, Pseudorabies virus Scrapie disease agent set forth in § 92.3, based on the risk of Guyana, Paraguay, Peru, Suriname, importing a restricted agent by Uruguay, Venezuela. (c) Restricted ectoparasites. The unrestricted importation of live animals. Surveillance. Systems to find, following ectoparasites of animals are Exporting regions will be classified into monitor, and confirm the existence or not known to exist in the United States one of the following risk classes: absence of a disease agent or agents in or are subject to cooperative Federal/ (1) Risk Class RN (Negligible Risk). A livestock, poultry and other animals. State control programs in the United Risk Class RN region is not known to be Surveillance may be passive or active. States: affected with a restricted agent, and is Susceptible animals. Animals that can (1) Ticks. physically isolated from any region become infected with a specific disease Amblyomma astrion known to be affected with a restricted agent. A. cohaerens agent. The probability in a Quantitative Swine. The domestic hog and all A. gemma Risk Assessment of the introduction of varieties of wild hogs. A. hebraeum a restricted agent through an Trail. Move animals from one place to A. javanense unrestricted importation from a Risk another by having them walk under A. lepidum Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17023

A. marmoreum (d) Restricted vector-borne disease Administrator determines that such A. pomposum agents that affect animals and that are vaccination would not increase the risk A. sparsum not known to exist in the United States of importing restricted agents into the A. testudinarium but which could be transmitted by United States); A. tholloni (iv) Any adjacent R1 or R2 regions for A. variegatum native vectors in the United States. the restricted agent are separated by Boophilus annulatus (1) Tick-borne agents. B. decoloratus natural or man-made physical barriers Bovine petechial fever (Ondiri disease) due B. florae or protected borders; to (Cytoecetes) ondiri B. geigyi (v) All border access points from Congo (Crimean Hemorrahagic Disease) virus B. kohlsi adjacent R1 or R2 regions for the Heartwater due to Cowdria ruminatium B. microplus restricted agent are controlled to prevent Jembrana (Tabanan) virus Dermacentor daghestanicus Nairobi sheep disease (Dugbe, Ganjam) virus movement of susceptible animals or D. marginatus Theileria spp. (east coast fever, corridor animal products from the adjacent D. nuttalli disease, Mediterranean fever) regions except under conditions that D. pictus Tick-borne encephalitis (louping ill, Central have been reviewed and approved by D. reticulatus European encephalitis) virus D. silvarium the Administrator; Tick-borne fever due to Erlichia (Cytoecetes) bispinosa (vi) Movement of animals and animal phagocytophilia H. leachii products into the region from R1, R2, H. longicornis (2) Insect-transmitted agents. R3, R4 or RU regions for the restricted H. otophila agent is done only under conditions that African (salivarian- or tsetse-transmitted) H. punctata Trypanosoma spp. (T. brucei, T. have been reviewed by the H. sulcata congolense, T. evansi, T. suis, T. simiae, T. Administrator and that have been Hyalomma anatolicum anatolicum uniforme, T. vivax) determined to achieve the same level of H. anatolicum excavatum Aino virus biosecurity as required for importations H. detritum Akabane virus from R1, R2, R3, R4, or RU regions into H. dromedarii Besnoitia besnoiti (globidiosis) H. marginatum marginatum the United States; Bluetongue virus (except serotypes 10, 11, 13 H. marginatum rufipes (vii) The region maintains a passive and 17) H. marginatum turanicum surveillance system to detect restricted Bovine ephemeral fever group (Kotonkan, H. scupense agents in a timely fashion, as Obodhiang) virus H. truncatum determined by the Administrator; and Epizootic hemorrhagic disease of deer Ixodes persulcatus (viii) The region maintains policies (Ibaraki) virus (except serotypes 1 and 2) I. pilosus Getah virus and infrastructure to respond to any I. Japanese encephalitis virus occurrences of a restricted agent. Onithodoros erraticus Lumpy Skin disease virus (2) The region or country requesting O. moubata Parafilariosis due to Parafilaria bovicola Risk Class RN classification submits a O. moubata porcinus Rift Valley fever virus quantitative risk assessment that is Rhipicephalus appendiculatus Trypanosoma spp. transmitted by vectors R. bursa determined by the Administrator to be other than tsetse flies (NTT-Trypanosomas) R. capensis scientifically valid and to demonstrate Wesselsbron virus that fewer than 1 per 1 million (1 × R. compositus (e) Other agents affecting domestic 10¥6) live animals in the region would R. evertsi evertsi livestock. R. evertsi mimeticus be expected to be affected with the R. glabroscutatum Taenia (Multiceps) multiceps (dog tapeworm) restricted agent. R. kochi in livestock handling dogs (3) A region previously classified as R. lunulatus Risk Class RN that has an occurrence of § 92.3 Criteria for risk classification. R. pulchellus the restricted agent may be reclassified R. simus (a) Risk Class RN Region (Negligible as Risk Class RN 3 years after all known R. turanicus Risk). A Risk Class RN region must meet infected and exposed reservoirs of the R. zambeziensis either the provisions of paragraphs disease in the region have been (a)(1)(i) through (a)(1)(viii) of this (2) Mites. eliminated. section or the provisions of paragraph (b) Risk Class R1 Region (Slight Risk). Chorioptes bovis, various subspecies of (a)(2) of this section, and, if applicable, A Risk Class R1 region must meet either which cause mange in horses, cattle, and the provisions of paragraph (a)(3) of this the provisions of paragraphs (b)(1)(i) sheep. section. through (b)(1)(ix) of this section or the Psorergates ovis, the causative agent of sheep (1)(i) The restricted agent has not been scabies. provisions of paragraph (b)(2) of this Psoroptes cuniculi, the causative agent of ear diagnosed within the region during the section, and, if applicable, the mange in goats and rabbits. lifetime of any currently living provisions of paragraph (b)(3) of this P. ovis, various subspecies of which cause susceptible animal; section. Common scabies in sheep, cattle, and (ii) The restricted agent is not known (1)(i) Except for BSE, the restricted horses. to exist within any adjacent defined agent has not been diagnosed within the Sarcoptes scabiei, various subspecies of region; region within the past 5 years; which cause scabies and mange in horses, (iii) Vaccination for the restricted (ii) For BSE, no cases have been cattle, sheep, and swine. agent has been prohibited within the diagnosed in the region within the last (3) Insects. region during the lifetime of any 10 years; currently living susceptible animal (iii) Vaccination for the restricted Chrysomyia bezziana (Old world screwworm) (exceptions may be made for certain agent is prohibited within the region Cochliomyia hominivorax (Callitroga diseases such as vector-transmitted (exceptions may be made for certain americana) (New world screwworm) diseases, or animals specifically restricted agents such as vector Hippobosca spp. and Lipoptema spp. (louse vaccinated to meet import requirements transmitted diseases or for animals flies) of other regions, when the specifically vaccinated to meet import 17024 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules requirements of other regions, when the (1)(i) Except for BSE or scrapie, the of the disease over the past 5 years has Administrator determines that such restricted agent has not been diagnosed not exceeded 0.1 percent; vaccination would not increase the risk within the region during the past year (ii) An active control program with a of importing restricted agents into the and the maximum annual herd goal of eradication for the restricted United States); incidence of the restricted agent over agent is in operation in the region; (iv) Any animals previously the past 5 years is less than 0.1 percent; (iii) Vaccination for the restricted vaccinated against the disease have been (ii) For BSE and scrapie, there have agent is currently limited to those herds slaughtered or moved out of the region, been no cases of the disease during the at greatest risk of infection (exceptions or are under provisional quarantine past 5 years; may be made for certain diseases, such (exceptions may be made for certain (iii) Vaccination for the restricted as vector-transmitted diseases, or for restricted agents such as vector- agent is prohibited within the region or animals specifically vaccinated to meet transmitted diseases or animals is limited to those herds that are at import requirements of other regions, specifically vaccinated to meet import greatest risk of exposure from animals when the Administrator determines that requirements of other regions, when the from affected regions (exceptions may such vaccination would not increase the Administrator determines that such be made for certain diseases such as risk of importing restricted agents into vaccination would not increase the risk vector-transmitted diseases or animals the United States); of importing restricted agents into the specifically vaccinated to meet import (iv) Any adjacent R4 or RU regions for United States); requirements of other regions, when the the restricted agent are separated by (v) Any adjacent R2, R3, R4 or RU Administrator determines that such natural or man-made physical barriers regions for the restricted agent are vaccination would not increase the risk or protected borders; separated by natural or man-made of importing restricted agents into the (v) All border access points from physical barriers or protected borders; United States); adjacent R3, R4 or RU regions for the (vi) All border access points from (iv) Any adjacent R3, R4 or RU restricted agent are strictly controlled to adjacent R2, R3, R4 or RU regions for regions for the restricted agent are prevent movement of susceptible the restricted agent are strictly separated by natural or man-made animals or animal products from the controlled to prevent movement of physical barriers, or protected borders; adjacent regions except under susceptible animals or animal products (v) All border access points from conditions that have been reviewed and from the adjacent regions, except under adjacent R3, R4 or RU regions for the approved by the Administrator; (vi) Movement of animals and animal conditions that have been reviewed and restricted agent are controlled to prevent products into the region is done only approved by the Administrator; movement of susceptible animals or (vii) Movement of animals and animal under conditions that have been animal products from the adjacent products into the region from R2, R3, R4 reviewed by the Administrator and that regions except under conditions that or RU regions for the restricted agent is have been determined to achieve the have been reviewed and approved by done only under conditions that have same level of biosecurity as required for the Administrator; been reviewed by the Administrator and importation from R4 or RU regions into (vi) Movement of animals and animal have been determined to achieve the the United States; products into the region from R3, R4 or same level of biosecurity as required for (vii) The region maintains passive and RU regions for the restricted agent is importation from R2, R3, R4, or RU active surveillance systems to detect the done only under conditions that have regions into the United States; restricted agent in a timely fashion, as been reviewed by the Administrator and (viii) The region maintains passive determined by the Administrator; and and active surveillance systems to that have been determined to achieve (viii) The region maintains policies detect restricted agents in a timely the same level of biosecurity as required and infrastructure to eliminate any fashion, as determined by the for importation from R3, R4, or RU outbreaks of the restricted agent that Administrator; and regions into the United States; may occur. (ix) The region maintains policies and (vii) The region maintains passive and (2) The region or country requesting infrastructure to respond to any active surveillance systems to detect the Risk Class R3 classification submits a occurrences of a restricted agent. restricted agent in a timely fashion, as quantitative risk assessment that is (2) The region or country requesting determined by the Administrator; and determined by the Administrator to be Risk Class R1 classification submits a (viii) The region maintains policies scientifically valid and to demonstrate quantitative risk assessment that is and infrastructure to respond to any that fewer than 1 per 1,000 (1×10¥3) live determined by the Administrator to be occurrences of the restricted agent. animals in the region would be expected scientifically valid and to demonstrate (2) The region or country requesting to be affected with the restricted agent. that fewer than 1 per 100,000 (1 × 10¥5) Risk Class R2 classification submits a (e) Risk Class R4 Region (High Risk). live animals in the region would be quantitative risk assessment that is A Risk Class R4 region must meet either expected to be affected with the determined by the Administrator to be the provisions of paragraphs (e)(1)(i) restricted agent. scientifically valid and to demonstrate through (e)(1)(vi) of this section or the (3) A region previously classified as that fewer than 1 per 10,000 (1×10¥4) provisions of paragraph (e)(2) of this Risk Class RN or R1 that has an live animals in the region would be section. (1)(i) A restricted agent has occurrence of a restricted agent may be expected to be affected with the been diagnosed within the region within reclassified as R1 2 years after all known restricted agent. the past year and the annual herd infected and exposed reservoirs of the (d) Risk Class R3 Region (Moderate incidence of the disease over the past 5 restricted agent in the region have been Risk). A Risk Class R3 region must meet years may have exceeded 0.1 percent in eliminated. either the provisions of paragraphs 1 or more years or is unknown; (c) Risk Class R2 Region (Low Risk). (d)(1)(i) through (d)(1)(viii) of this (ii) A control program for restricted A Risk Class R2 region must meet either section or the provisions of paragraph agents may be in operation in the region the provisions of paragraphs (c)(1)(i) (d)(2) of this section. but does not meet the minimum through (c)(1)(viii) of this section or the (1)(i) The restricted agent has been standards for a Risk Class R3 region; provisions of paragraph (c)((2) of this diagnosed within the region during the (iii) Vaccination for the restricted section. past year, but the annual herd incidence agent may vary from herd to herd. If Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17025 vaccination is used as the primary reviewed and acted upon according to HC = Hog Cholera (Classical swine control procedure, at least 80 percent of the procedures set forth in § 92.5. fever) virus the livestock in 80 percent of the herds HW = Heartwater due to Cowdria must be vaccinated as often as § 92.4 Risk classification by region and ruminatium restricted disease agent. recommended by the manufacturers of JEM = Jembrana (Tabanan) virus the vaccine; (a) Risk classification by region. JEV = Japanese encephalitis virus (iv) Movement of animals and animal Abbreviations used: LSD = Lumpy Skin disease virus products into the region may not be AIN = Aino virus MCF = Malignant catarrhal fever virus adequately controlled from regions that AKA = Akabane virus (African or Wildebeest form) are Risk Class R3, R4, or RU for the ASF = African swine fever virus MEL = Pseudomonas pseudomallei restricted agent; BB = Besnoitia besnoiti (globidiosis) (melioidosis) (v) The region maintains a passive BEF = Bovine ephemeral fever group NEE = Near East Encephalitis virus (Kotonkan Obodhiang) virus and active surveillance system for the NSD = Nairobi sheep disease (Dugbe, BLU = Bluetongue virus (except restricted agent at a level that may not Ganjam) virus serotypes 10, 11, 13 and 17) fully meet standards for a Risk Class R3 PARF = Parafilariosis due to Parafilaria BPF = Bovine petechial fever (Ondiri region; and bovicola disease) due to Erlichia (Cytoecetes) (vi) The region maintains policies and PPR = Peste des petits ruminants (Kata) ondiri infrastructure to effectively control and BR-A = Brucella abortus (brucellosis or virus restrict spread of any outbreaks of the Bangs disease) PRV = Pseudorabies virus restricted agent that may occur. BR-M = Brucella melitensis RP = Rinderpest virus (2) The region or country requesting BR-S = Brucella suis RVF = Rift Valley fever virus Risk Class R4 classification submits a BR-S4 = Brucella suis biovar 4 SCR = Scrapie disease agent quantitative risk assessment that is BSE = Bovine spongiform SPV = Sheep pox virus determined by the Administrator to be encephalopathy (BSE) agent SVD = Swine vesicular disease virus scientifically valid and to demonstrate CASG = Contagious agalactia of sheep TB = Mycobacterium bovis (bovine × ¥2 that fewer than 1 per 100 (1 10 ) live and goats (Mycoplasma agalactiae) tuberculosis) animals in the region would be expected CBPP = Contagious bovine TBE = Tick-borne encephalitis (louping to be affected with the restricted agent. pleuropneumonia (Mycoplasma ill, Central European encephalitis) (f) Risk Class RU Region (Unknown mycoides subsp. mycoides) virus Risk). A Risk Class RU region will be CCPP = Contagious caprine TBF = Tick-borne fever due to Erlichia classified using the following criteria: pleuropneumonia (Mycoplasma (Cytoecetes) phagocytophilia. (1) All countries and regions of the mycoides subsp. capri) TD = Teschen disease virus world that do not have specific CHD = Congo (Crimean Hemorrhagic TM = Taenia (Multiceps) multiceps (dog classification as Risk Class RN, R1, R2, Disease) virus tapeworm) in livestock handling dogs R3 or R4, and that have not been ECF = Theileria spp. (east coast fever, TRY-NTT = Trypanosoma spp. previously designated as a country not corridor disease, Mediterranean fever) transmitted by vectors other than affected with a restricted agent will be ECTO = Restricted ectoparasites tsetse flies (NTT-Trypanosomas) classified as an RU region. EHD = Epizootic hemorrhagic disease of TRY-TT = African (salivarian- or tsetse- (2) Any region classified in this part deer (Ibaraki) virus (except serotypes transmitted) Trypanosoma spp. (T. as an RU region for any restricted agents 1 and 2) brucei, T. congolense, T. evansi, T. of livestock may request classification as FMD = Foot-and-mouth disease virus suis, T. simiae, T. uniforme, T. vivax) an RN, R1, R2, R3, or R4 region. All GET = Getah virus VSV = Vesicular Stomatitis virus requests for reclassification will be GPV = Goat pox virus WB = Wesselsbron virus 17026 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules BB, BEF, BPF, BR-A, BR-M, BR-S, CASG, CBPP, CHD, CCPP, ECF, ECTO, EHD, FMD, GPV, HC, HW, LSD, MCF, MEL, NEE, NSD, PARF, PPR, PRV, RP, RVF, SCR, SPV, SVD, TM, TB, TBF, TRY-NTT, TRY-TT, WB. Risk class RU regions AIN, AKA, ASF, BLU, Risk class R4 regions Risk class R3 regions Risk class R2 regions Risk class R1 regions ...... JEV, TD, TBE, VSV Risk class RN regions BSE, BR-S4, GET, JEM, Region Princip ...... Algeria Angola Benin Botswana Burkina Faso Burundi Cameroon Cent. African Rep. Chad Comoros Congo Djibouti Egypt Equatorial Guinea Gabon Ghana Guinea Guinea-Bissau Ivory Coast Kenya Lesotho Liberia Libya Madagascar Malawi Mali Mauritania Morocco Mozambique Namibia Niger Nigeria Rwanda Sao Tome and Senegal Sierra Leone Somalia South Africa Sudan Swaziland Tanzania The Gambia Togo Africa Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17027 Japan & except Japan & South

except

BEF, BR±A Japan; BR±M, BR±S, CASG, CBPP, CHD, CCPP, ECTO, EHD, FMD South Korea; GET, GPV, HW, HC, JEV, MEL, NEE, NSD, PARF, PPR, PRV, RP except Korea; SCR, SPV, SVD, TM, TB, TBE, TBF, TRY±NTT. JEM JEM JEM BR±S4 JEM JEM AIN, AKA, BLU, BB, JEM JEM JEM JEM JEM JEM ...... BR±A ...... FMD, RP FMD, RP . Russia; ECF, ......

except LSD, MCF, RVF, TD, TRY±TT, VSV, WB ASF, BPF, BSE, BR±S4 JEM JEM JEM JEM JEM JEM JEM JEM JEM JEM JEM JEM JEM JEM JEM JEM JEM JEM JEM JEM JEM JEM ...... Tunisia Uganda Western Sahara Zaire Zambia Zimbabwe Afghanistan Armenia Azerbaijan Bangladesh Bhutan Burma Cambodia China Georgia Hong Kong India Iran Japan Kazakhstan Kygyzstan Laos Macau Malaysia Mongolia Nepal North Korea Pakistan Russia Singapore South Korea Sri Lanka Taiwan Tajikistak Thailand Turkistan Ukraine Uzbekistan Vietnam Asia 17028 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

ex- the

except

except except

except Bermuda; SCR, S, CASG, ECTO, EHD, FMD Bermuda; HW, HC, PARF, PRV, RP SVD, TM, TB Bermuda and Falkland Islands. BEF, BR±S, CHD, CCPP, ECTO, EHD, GET, GPV, JEV, MEL, PARF, PRV, TM, TB. Haiti, Dominican Re- public, and The Baha- mas; TB Bahamas, TRY±NTT. cept S, BSE, ECTO, EHD, HW, HC, MEL, PRV, SCR, SVD Risk class RU regions ASF BLU, BR±A, BR±M, BR± AIN, AKA, ASF, BLU, ASF BLU, BR±A, BR±M, BR± Risk class R4 regions Risk class R3 regions Risk class R2 regions ...... Cuba and ......

except Haiti, Risk class R1 regions ...... FMD, RP BR±A, CBPP, JEM ASF . . The

except .

except ...... BR±S4, BSE, CASG, ECF, FMD, HW, HC, LSD, MCF, NEE, NSD, PPR, RP, RVF, SCR, SPV, SVD, TBE, TBF, TD, TRY±NTT, TRY±TT, VSV, WB Bahamas GET, GPV, JEV, JEM, LSD, MCF, NEE, NSD, PARF, PPR, RVF, RP The Bahamas, SPV, TM, TBE, TBF, TD, TRY±TT, VSV, WB BEF, BPF, BSE, BR± S4, CHD, CBPP, CCPP, ECF, GET, GPV, JEV, JEM, LSD, MCF, MEL, NEE, NSD, PPR, NEE, RVF, SPV, TD, TBE, TBF, TRY±NTT, TRY± TT, VSV, WB BPF, BR±S4, CASG, CBPP, CHD, CCPP, ECF, FMD Risk class RN regions TB ASF, BB, BPF, BR±M, SVD, TB ASF, AIN, AKA, BB, FMD, RP, TB AIN, AKA, BB, BEF, SVD SVD ...... Region ...... Bermuda Cape Verde Falkland Islands South Georgia Anguilla Aruba Barbados British Virgin Islands Cayman Islands Cuba Dominica Dominican Republic Grenada Guadeloupe Haiti Jamaica Martinique Montserrat Netherlands Antilles Puerto Rico Saint Lucia Saint Vincent The Bahamas Atlantic Australia Caribbean Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17029 Ireland

except and United Kingdom; CASG, CHD, CCPP, ECTO, GPV, PARF, PRV, SCR, SPV, TM, TBE, TBF, TD. SVD, TB. SVD, TB. FMD, TB. TB. TB. SVD, TB. SVD, TB. SVD, TB. FMD, RP, TB. TB. SVD, RP, TB. TB. BR±A, BSE, SVD, TB. TB. BR±A, BR±M, SVD, TB. BR±M, SVD, TB. BR±A, SVD, TB. BR±A, BSE, TB. BB, BR±S BR±A, BR±M, FMD, RP, BR±A, BR±M, FMD, RP, BR±A, BR±M, TB. BR±A, BR±M, SVD, TB. BR±A, BR±M, RP, SVD, FMD, RP, SVD, TB. BR±A, FMD, RP, SVD, BR±A, FMD, RP, SVD, FMD, RP, SVD, TB. BSE, TB. BR±A, BR±M, FMD, RP, TB. BR±A, BR±M, FMD, RP, BR±A, BR±M, FMD, RP, BR±A, BR±M, SVD, BR±A, SVD, FMD, RP, BR±A, BR±M, FMD, BR±A, FMD, RP. BR±M, SVD, TB. BR±A, FMD, SVD, RP, ...... Italy, Spain, ......

except BSE and Portugal SVD FMD, RP CBPP, RP, BSE CBPP, FMD, RP, SVD, CBPP, RP, BSE CBPP, RP, BSE CBPP, RP, BSE BR±A, BSE, CBPP, RP CBPP, RP, BSE CBPP FMD, RP CBPP, RP, BSA CBPP, RP, BSE CBPP, BSE CBPP, FMD, BSE, RP CBPP, BSE CBPP, FMD, RP, SVD CBPP, RP, BSE CBPP, RP, BSE CBPP, RP, BSE, SVD ASF CBPP, RP, BSE CBPP, FMD, RP, BSE CBPP, RP, BSE CBPP, FMD, RP, SVD CBPP, FMD, BSE, RP CBPP, BR±A, BSE, CBPP, RP BSE CBPP, RP, BSE ......

except ...... Greece BEF, BPF, BR±S4, ECF, EHD, GET, HW, JEV, JEM, LSD, MCF, MEL, NEE, NSD, PPR, RVF, TRY±NTT, TRY±TT, VSV, WB ...... BR±A BR±M BR±A, BR±M BR±M BR±A, BR±M, TB BR±M, FMD, RP BR±A BR±M, FMD, RP BR±M, BR±S BR±M BR±M, TB AIN, AKA, BLU FMD, RP BR±M ...... St......

...... except ...... bago Pierre and Miquelon St Pierre and Miquelon) Trinidad and To- Turks and Caicos U.S. Virgin Islands Albania Andorra Austria Belgium Bosnia-Herzogovina Bulgaria Bylorus Croatia Czech Republic Denmark Estonia Finland France France France (Territory of Germany Gibraltar Greece Greenland Hungary Iceland Ireland Italy Latvia Liechtenstein Lithuania Luxembourg Europe 17030 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

except SVD, RP, TB. TB. SVD, TB. SVD, RP, TB. SVD, RP, TB. TB. SVD, RP, TB. SVD, TB. Jersey. TB. SVD, TB. Belize; BR±M, BR±S, ECTO, EHD, HC, MEL, PRV, SCR, TB, TRY±NTT, VSV. Risk class RU regions BRA±A, SVD. CBPP, BR±A, BR±M, FMD, BSE, SVD, RP, BR±A, BR±M, CBPP, BR±M, BSE, RP, TB. BR±A, BR±M, FMD, BR±A BR±M, FMD, BR±M, FMD, SVD, RP, BR±A, BR±M, FMD, BR±A, BR±M, FMD, RP, BSE, TB except Isle of TB. BR±A, BR±M, SVD, RP, BR±A, BR±M, FMD, RP, BLU, BR±A BR±A, SVD, TB. RP, TB. Risk class R4 regions Risk class R3 regions Risk class R2 regions ...... SVD BSE Risk class R1 regions ...... CBPP, RP, BSE CBPP, FMD, BSE, RP FMD, BSE, RP CBPP, RP, BSE CBPP, RP, BSE CBPP, BR±A, RP CBPP, RP, BSE FMD, RP, BSE CBPP, FMD, RP, SVD CBPP, RP, BSE FMD CBPP, RP, BSE CBPP, FMD, RP, BSE, CBPP, FMD, RP, SVD, CBPP, RP, SVD CBPP, BR±A, RP, SVD CBPP, RP, BSE CBPP, FMD, BSE, RP ...... Panama; ......

except ...... GET, GPV, HW, JEV, JEM, LSD, MCF, NEE, NSD, PARF, PPR, RP, RVF, SPV, SVD, TM, TBE, TBF, TD, TRY±TT, WB BEF, BPF, BSE, BR± S4, CASG, CBPP, CHD, CCPP, ECF, FMD Risk class RN regions BR±M BR±A BR±M BR±A BR±A, BR±M, BR±S BR±M, BR±S TB BR±A BR±M BR±A, BR±M, TB BR±A, BR±M ASF, AIN, AKA, BB, ...... Region (Channel Islands) (England, North- ern Ireland, Scot- land, Wales, Isle of Man) (Isle of Jersey) Moldavia Monaco Netherlands Norway Poland Portugal Romania San Marino Slovakia Slovenia Spain Sweden Switzerland United Kingdom United Kingdom United Kingdom Vatican City Yugoslavia Belize Costa Rica El Salvador Guatemala Honduras Nicaragua Panama Middle America Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17031

except Cyprus

except BR±A & Israel; BR±M, BR± S, CASG, CBPP, CHD, CCPP, ECTO, EHD, FMD, GPV, HC, LSD, MEL, NEE, PARF, PPR, PRV, RP, RVF, SCR, SPV, SVD, TM, TB Cyprus; TBF, TRY± NTT. ECTO, PRV, TM, TB. AIN, AKA, BLU, BB, BR±A, BR±S, CASG, BR±S4 ...... SCR ...... TB ...... Oman ......

except ...... BSE BR±A ...... ECF, GET, HW, JEV, JEM, NSD, MCF, TBE, TD, TRY±TT, VSV, WB BB, BEF, BPF, BR±M, BR±S4, BSE, CBPP, CHD, CCPP, ECF, EHD, FMD, GET, GPV, HW, HC, JEV, JEM, LSD, MCF, MEL, NEE, NSD, PARF, PPR, RP, RVF, SCR, SPV, SVD, TBE, TBF, TD, TRY±NTT, TRY±TT, VSV, WB BEF, BPF, BLU, CASG, CBPP, CHD, CCPP, ECF, EHD, FMD, GET, GPV, HW, JEV, JEM, LSD, MCF, NEE, NSD, PARF, PPR, RP, RVF, SPV, SVD, TM, TBE, TBF, TD, TRY±NTT, TRY± TT, WB HC, MEL, PRV ASF, BEF, BPF, BR±S4, BR±A, TB BR±A ASF, AIN, AKA, BLU, ASF, AIN, AKA, BB, BR±M, BR±S, ECTO, ...... ates Bahrain Cyprus Iraq Israel Jordan Kuwait Lebanon Malta North Yemen Oman Palestine Qatar Saudi Arabia South Yemen Syria Turkey United Arab Emir- New Zealand Canada Middle East North America 17032 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

ex- French Argen- Chile; TM, TB, except

except the State of So-

cept nora; MEL, BR±M, BR±S, PRV, SCR, TB, VSV. BR±A Polynesia & Papua New Guinea; BR±S, CASG, CBPP, CCPP, ECF, ECTO, EHD, GET, GPV, HC, JEV, JEM, MEL, PARF, PRV, SCR, SPV, TM, TB, TRY±NTT. BR±S, ECTO, EHD, FMD tina, Chile, and Uru- guay; GPV, HC, MEL, PRV, SCR, SPV, SVD except TRY±NTT, VSV. Risk class RU regions FMD, SVD, RP. FMD, SVD, RP. FMD, SVD, RP. FMD, SVD, RP. FMD, SVD, RP. ASF. BR±A, ECTO, HC AIN, AKA, BEF, BLU, FMD, SVD, RP. FMD, SVD, RP. FMD, SVD, RP. FMD, SVD, RP. FMD, SVD, RP. FMD, SVD, RP. FMD, SVD. SVD. FMD, SVD, RP. FMD, SVD, RP. BLU, BB, BR±A, BR±M, Risk class R4 regions Risk class R3 regions Risk class R2 regions FMD ...... Brazil ......

except . Risk class R1 regions ...... HC ASF FMD, RP, SVD FMD, RP FMD, RP FMD, RP Chile, .

except ...... BR±S4, BSE, CASG, CBPP, CHD, CCPP, ECF, GET, HW, JEV, JEM, LSD, MCF, NEE, NSD, PARF, PPR, RP RVF, TBE, TBF, TD, TRY±TT, WB BR±M, BR±S4, CHD, HW, LSD, MCF, NEE, NSD, PPR, RVF, TBE, TBF, TD, TRY±TT, VSV, WB Risk class RN regions ...... FMD, RP, SVD AIN, AKA, BEF, BPF, ASF, BB, BPF, BSE, SVD BR±A BR±A ...... Region ...... in Mexico Pacific Islands Mexico The State of Sonora United States Brunei Fiji French Polynesia Indonesia Kiribati Maldives Mauritius Nauru New Caledonia Papau New Guinea Philippines Seychelles Solomon Islands Tonga Trust territory of the Vanuatu Western Samoa Argentina Bolivia Brazil Chile Oceania South America Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17033 FMD ...... Risk classification by restricted disease agent. Colombia Ecuador French Guiana Guyana Paraguay Peru Suriname Uruguay Venezuela (b) 17034 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules those specifi- Do. Do. Do. Do. Do. Do. Do. Do.

except cally listed as Risk Class RN, R1, R2, R3 or R4 Risk class RU regions All regions of the world ...... Risk class R4 regions ...... do ...... do ...... do ...... do None ...... do ...... do ...... do ...... do ...... Risk class R3 regions ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do None ...... Risk class R2 regions ...... do ...... do ...... do ...... do None ...... do ...... do ...... do Canada . Brazil . except Italy, . except except

except

except ...... Spain and Portugal; Caribbean Cuba and Haiti; South America Oman; Europe Denmark, France, United Kingdom, Re- public of Ireland, and Switzerland Czech Republic, Ger- many, Slovakia, Unit- ed Kingdom except Channel Islands Risk class R1 regions Europe None ...... do ...... do ...... do Middle East Australia, Canada, ...... do ...... do . Can- Greece, . .

except .

except . . . . . Middle America, New Zealand, North Amer- ica, Oceania rope, Middle America, New Zealand, North America, South Amer- ica rope, Middle America, New Zealand, North America, South Amer- ica bean, Middle America, North America, Oce- ania Caribbean, Europe, Middle America, Mid- dle East, New Zea- land, North America, Oceania, South Amer- ica Australia, Caribbean, Middle America, New Zealand, Oceania, South America, North America ada nel Islands (United Kingdom), Cyprus, Denmark, Finland, French Polynesia, Hungary, Israel, Nor- way, Papua New Guinea, Romania, Sweden, Switzerland New Zealand, Can- ada, Mexico rope, Middle America, Middle East, New Zealand, North Amer- ica, Oceania, South America Risk class RN regions Asia, Atlantic, Australia, Atlantic, Caribbean, Eu- Atlantic, Caribbean, Eu- Atlantic, Australia, Carib- Europe Asia, Atlantic, Australia, Africa, Asia, Atlantic, Belize, Bulgaria, Chan- Atlantic, Caribbean, Eu- ...... (globidosis) serotypes 10, 11, 13, 17) virus group (Kotonkan, Obodhiang) chial fever encephalopathy Restricted disease agent

African swine fever Aino virus Akabane virus Besnoitia besnoitii Bluetongue virus (except Bovine ephemeral fever Bovine infectious pete- Bovine spongiform Brucella abortus Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17035 Do. Do. Do. Do. Do. Do. Do. Do. Do...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do Argentina . Portugal ...... except ...... and Spain; Australia; Oceania Belgium, Chile, Den- mark, Fiji, Finland, France, Germany, United Kingdom, Hun- gary, Japan, New Cal- edonia, The Nether- lands, Norway, Papua New Guinea, Panama, Poland, Portugal, Re- public of Ireland, Re- public of Korea, Swe- den, Spain, Switzer- land, Uruguay None ...... do ...... do ...... do Europe ...... do Mexico Austria, The Bahamas, None . . The . Rus- Pan- .

except

except

except . . . . . Zealand, Canada, Czech Republic, Den- mark, Estonia, Fin- land, Greenland, Ice- land, Ireland,Latvia, Lithuania, Luxem- bourg, Netherlands, Norway, Poland, Slo- vakia, Sweden, United Kingdom, Taiwan Kingdom sia; Atlantic; Australia; Caribbean; Europe; Mexico; Middle Amer- ica; Middle East; New Zealand; Oceania, South America dle America, New Zealand; North Amer- ica, Oceania; South America Middle America, New Zealand, North Amer- ica, South America dle America, New Zealand, North Amer- ica, South America Bermuda; all regions of North and Middle America ama; all regions of the Caribbean dle America, New Zealand, North Amer- ica, and South Amer- ica Zealand Bahamas; Greenland; Iceland; Territory of St. Pierre and Miquelon; Trust terri- tory of the Pacific Is- lands Oceania, Australia, New Canada, Ireland, United Africa; Asia Atlantic, Caribbean, Mid- Australia, Caribbean, Atlantic, Caribbean, Mid- Australia; Barbados; Atlantic, Caribbean, Mid- Canada, Europe, New ...... except except . subsp. subsp. ). . . ). .

Mycoplasma

Mycoplasma Mycoplasma biovar 4 biovar 4 Hemorrhagic Disease) sheep and goats due to agalactiae pleuro-pneumonia ( mycoides mycoides pleuro-pneumonia ( mycoides capri disease of deer (Ibaraki) virus (except serotypes 1 and 2) virus

Brucella melitensis Brucella suis Brucella suis Congo virus (Crimean Contagious agalactia of Contagious bovine Contagious caprine Epizootic hemorrhagic Foot-and-mouth disease 17036 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules Do. Do. Do. Do. Do. Do. Do. Risk class RU regions ...... Risk class R4 regions ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... Risk class R3 regions ...... do ...... do ...... do ...... do ...... do ...... do None ...... Risk class R2 regions ...... do ...... do None None ...... do ...... do ...... do ...... Spain, the State of Sonora in Mexico Risk class R1 regions None Denmark, Finland, ...... do None None ...... do ...... do

ex- ...... for Bangladesh, .

bean; Europe; Middle America; Middle East; New Zealand; North America; and South America Europe; Middle Amer- ica; Middle East; New Zealand; North Amer- ica; Oceania; and South America minican Republic, Fiji, United Kingdom, Ice- land, New Zealand; Northern Ireland, Nor- way, the Republic of Ireland, Sweden, and Trust Territory of the Pacific Islands bean, Europe, Middle America, Middle East, New Zealand, North America, and South America cept Bhutan, Burma, Cam- bodia, India, Laos, Malaysia, Singapore, Sri Lanka, Thailand, and Vietnam; Carib- bean; Europe; Middle America; Middle East; New Zealand; North America; South Amer- ica Caribbean, Europe, Middle America, New Zealand, North Amer- ica, Oceania, South America Caribbean, Europe, Middle America, Mid- dle East, New Zea- land, North America, Oceania, and South America Risk class RN regions Africa; Atlantic; Carib- Asia; Atlantic; Australia; Australia, Canada, Do- Africa, Atlantic, Carib- Africa; Atlantic; Asia Asia, Atlantic, Australia, Asia, Atlantic, Australia, ......

Cowdria ruminantium swine fever) virus virus (Neethling virus) virus (African or wilde- beest form) Restricted disease agent Getah virus Heartwater due to Hog cholera (classical Japanese encephalitis Jembrana (Tabanan) Lumpy skin disease Malignant catarrhal fever Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17037 Do. Do. Do. Do. Do. Do. Do. Do. Do. Do. Do. Do...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... None ...... do ...... do ...... do ...... do Canada ...... do ...... do ...... do ...... do ...... do ...... do ...... Belgium, Chile, Den- mark, Finland, Fiji France, Germany, United Kingdom, Hun- gary, Japan, The Netherlands, New Cal- edonia, Norway, Papua New Guinea, Poland, Ireland, South Korea, Spain, Sweden ...... do ...... do ...... do Canada Austria, The Bahamas, None ...... do ...... do ...... do None ...... do ...... do . . . . The Ba- . Chile; Car- . . . except ...... except Falkland Islands, Lux- embourg, Norway, Isle of Jersey (United Kingdom), Cyprus bean, Europe, Middle America, Middle East, New Zealand, North America, Oceania, and South America bean, Europe; Middle America, New Zea- land, North America, Oceania, and South America America, South Amer- ica, Caribbean America, South Amer- ica, Australia, Oceania Caribbean, Europe, Middle America, New Zealand, North Amer- ica, Oceania, South America North America; Middle America; South Amer- ica ibbean hamas; Greenland; Iceland, Japan, Terri- tory of St. Pierre and Miquelon, Trust terri- tory of the Pacific Is- lands, Papua New Guinea, Republic of Korea bean, Middle America, New Zealand, North America Bermuda, The Bahamas, Atlantic, Australia, Carib- Atlantic, Australia, Carib- North America, Middle Atlantic, Europe, North None Asia, Atlantic, Australia, Australia; Bermuda; Australia, New Zealand Europe, Canada, Atlantic Canada Atlantic, Australia, Carib- ......

(Ganjam, Dugbe) virus virus Parafilaria bovicola ruminants (Kata) virus pseudomallei (melioidosis) (Aujesky's) virus pox virus

Mycobacterium bovis Nairobi sheep disease Near East encephalitis Parafilariosis due to Peste des petits Pseudomonas Pseudorabies Restricted ectoparasites Rift Valley fever virus Rinderpest virus Scrapie disease agent Sheep pox and/or goat 17038 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules Do. Do. Do. Do. Do. Do. Do. Do. Do. Risk class RU regions ...... Risk class R4 regions ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... Risk class R3 regions ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... Risk class R2 regions ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... do ...... Bosnia-Herzogovania, Bulgaria, Chile, Cro- atia, Denmark, Ireland, Luxembourg, Macedo- nia, Ireland, Slovenia, Switzerland, United Kingdom, Yugoslavia Risk class R1 regions Austria, The Bahamas, None ...... do ...... do ...... do ...... do ...... do ...... do ...... do . . Mex- . . .

except . . . . Middle America, Do- minican Republic, Fiji, Finland, Greenland, Haiti, Iceland, New Zealand, Norway, Ru- mania, Sweden, Trust Territories of the Pa- cific Islands America, Caribbean Caribbean, Europe, Middle America, Mid- dle East, New Zea- land, North America, Oceania, South Amer- ica Caribbean, Middle America, Middle East, New Zealand, North America, Oceania, South America bean, Middle America, Middle East, New Zealand, North Amer- ica, Oceania, South America Caribbean, Europe, Middle America, Mid- dle East, New Zea- land, North America, Oceania, South Amer- ica rope, New Zealand, and North America ico; Oceania Australia, Caribbean, Middle America, Mid- dle East, New Zea- land, North America, Oceania, South Amer- ica Australia; Caribbean; Europe; Middle East; New Zealand; North America Risk class RN regions Australia, North America, North America, Middle Atlantic, Asia, Australia, Africa, Atlantic, Australia, Atlantic, Australia, Carib- Asia, Atlantic, Australia, Atlantic, Australia, Eu- Africa, Asia, Atlantic, Africa; Asia; Atlantic; ... .

T. . . . African spp. trans- (dog tape- ). . . worm) in livestock handling dogs virus multiceps fever, corridor disease Mediterranean fever) (louping ill, Central Eu- ropean encephalitis) virus Erlichia (Cytoecetes) phagocytophilia (salivarian-or tsetse- transmitted) spp. ( brucei, T. congolense, T. evansi, suis, simiae, T. uniforme, vivax mitted by vectors other than tsetse flies (NTT± Trypano-somas) Restricted disease agent

Swine vesicular disease Taenia (Multiceps) Teschen disease virus Theileriosis (east coast Tick-borne encephalitis Tick-borne fever due to Trypanosoma Trypanosoma Vesicular Stomatitis virus Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17039 Do...... do ...... do ...... do ...... do . Caribbean, Europe, Middle America, Mid- dle East, New Zea- land, North America, Oceania, South Amer- ica Asia, Atlantic, Australia, ...... Wesselsbron virus 17040 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

§ 92.5 Application for recognition of Risk health infrastructure, livestock recommendations. These Class RN, R1, R2, R3, or R4. populations, diagnostic facilities and recommendations may include, but are (a) Evaluation procedure. (1) The procedures, control, eradication, and not limited to: official of the national government of surveillance of the specific disease(s) in (i) Requesting additional information any country who has the authority in question. about the region, or the country if the that country to request such a change (5) When all of the requested region is part of a country, or other may request at any time that all or part information is received by APHIS, the countries if the region is made up of of the country be classified or Administrator will initiate an more than one country; reclassified as a Risk Class RN, R1, R2, investigation to document those claims (ii) Deferring any decision until a R3, or R4 region, or be included within represented in the completed veterinary team composed of staff an adjacent previously classified region. questionnaire. Following this representatives of APHIS can personally (2) Requests for classifying or investigation, a committee, composed of visit the region in question and do an reclassifying a region must be sent to the USDA veterinary experts, will be on-site evaluation of any concerns; Administrator, stating that the official convened to evaluate the information (iii) Denying the request, but making the request believes the region provided by the Chief Veterinary Officer specifying certain conditions that would is prepared to document all claims for the region and the investigative warrant further consideration, should represented that would permit the report submitted by APHIS. This the region decide to implement the region to be eligible for consideration committee will be formed by the committee’s recommendations; for a change in disease risk classification. Administrator when necessary to (iv) Denying the request, listing the (3) The Chief Veterinary Officer of the address any such requests for change in specific reasons for that action; region will then be sent a formal region risk class status and may be (v) Recommending reclassifying the questionnaire relating to the specific composed of representatives from region into a risk class other than the disease(s) in question. APHIS, other branches of the USDA, or risk class specifically requested; and (4) The Chief Veterinary Officer of the other persons knowledgeable about the (vi) Approving the request by the region must submit to APHIS the disease(s) in question from other region and recommending that the completed questionnaire, along with a Federal agencies. region be added to the list of risk class complete set of the region’s applicable (b) Decision procedures. (1) regions for which it applied. agricultural laws and regulations, Depending upon the information (2) After the committee has met and written in English (if the official provided by the Chief Veterinary Officer made a recommendation, a letter to the language of the country or region is of the region and the results of the Administrator will be prepared, stating other than English, there must be investigation by APHIS, the committee the recommendation of the committee, supplied an official certified translation may complete a risk analysis of the and will be signed by the committee into English), relative to the animal region and may make one of several chairperson. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17041

(c) Action on the committee’s appeal as outlined in this paragraph (c) committee and has furnished that recommendations. (1) If the and paragraph (d) of this section. information in writing, and this Administrator concurs with the (iii) If the request is still being information has been documented by committee’s recommendation, a letter considered, the letter will state that: the APHIS investigator assigned to will be sent to the foreign official who (A) Additional information is needed; conduct the investigation. made the request, informing him or her if furnished, the request will be (2) After the committee has as follows whether the request was reconsidered according to the reconvened and reconsidered the approved or denied, or is still being procedures outlined in paragraphs (a)(5) request, a letter to the Administrator considered: and (b) of this section; will be prepared stating the revised (B) An on-site visit is required before recommendation of the committee, and (i) If the request is approved, the letter a final decision can be made; and/or will be signed by the chairperson of the will state that a notice of proposed (C) The region must implement committee. rulemaking will be published in the certain actions for compliance with (e) Removal or change of status of Federal Register, proposing the status of APHIS requirements before it will be region due to failure to meet the criteria the region for the restricted agent in eligible for a reclassification. of the present risk class, or discovery of question. (iv) Final approval will be given by a restricted agent in the region. the Administrator by publishing a final (ii) If the request is denied, the letter (1) Whenever the Administrator rule Federal Register stating the status will state the reasons for that action. receives notice from the Chief The region will continue to be classified of the region for the restricted agent in question and the effective date of the Veterinary Officer representing any according to its current risk class or be region classified as Risk Class RN, R1 or classified as Risk Class RU if the region risk class change. The Administrator will notify the Chief Veterinary Official R2, either directly or through the had not been previously classified as of the country(ies) where the International Office of Epizootics, that a Risk Class RN, R1, R2, R3, or R4. The reclassified region is located when the restricted agent has been discovered decision may be appealed by final rule is published in the Federal within the region or that animals in the resubmitting the request to the Register. region have been exposed to a restricted Administrator and specifically (d) Committee follow-up, if needed. agent, the Administrator may responding to each of the reasons stated (1) The committee may be reconvened immediately suspend the current risk for denying the request, and supplying for final recommendation after: classification and reclassify the region any supporting information or data (i) An appeal has been made or as a Risk Class R3, R4 or RU region, and related to the reasons stated for denial. additional information needed is will publish a rule to that effect in the The committee will evaluate the appeal received; Federal Register. following the procedures outlined in (ii) An on-site evaluation report is (2) Whenever the Administrator paragraphs (a)(5) and (b) of this section. received; or determines that a region no longer meets The Administrator will act on the (iii) The region has implemented the criteria of its current Risk Class committee’s recommendation of the specific recommendations made by the classification, the Administrator shall 17042 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules take action to change the classification be removed and a reference to § 93.103 [Amended] of the region as he or she deems ‘‘§ 93.105’’ would be added in its place; 8. Newly designated § 93.103 would appropriate. g. In paragraph (c)(2)(i), the reference be amended as follows: (3) Reclassification pursuant to to ‘‘§ 92.101(c)(1)’’ would be removed a. In paragraph (a)(1), the reference to paragraph (e)(1) or (e)(2) of this section and a reference to ‘‘§ 93.101(c)(1)’’ ‘‘§§ 92.101 (b) and (c), 92.103(c), and shall remain in effect until either: would be added in its place; 92.214’’ would be removed and a (i) The official of the national h. In paragraph (c)(3), the reference to ‘‘§§ 93.101 (b) and (c), government of the country of origin who introductory text, the reference to 93.103(c), and 93.214’’ would be added has the authority to request a change ‘‘§ 92.102(a)’’ would be removed and a in its place; does so in accordance with the reference to ‘‘§ 93.102(a)’’ would be b. In paragraph (a)(1)(x), the reference procedures in paragraph (a) of this added in its place; to ‘‘§ 92.106(c)(5)’’ would be removed section; or i. In paragraph (c)(3)(ii), the references and a reference to ‘‘§ 93.106(c)(5)’’ (ii) The Administrator makes a to ‘‘§ 92.103(a)(3)’’ would be removed would be added in its place; determination based on the procedures both times they appear and references to c. In paragraph (a)(1)(xii), the in paragraph (b) of this section. ‘‘§ 93.103(a)(3)’’ would be added in their reference to ‘‘§§ 92.100 through 92.107’’ place, and the references to would be removed and a reference to PART 93ÐIMPORTATION OF CERTAIN ‘‘§ 92.102(a)’’ would be removed each ‘‘§§ 93.100 through 93.107’’ would be ANIMALS AND POULTRY; time they appear and references to added in its place; INSPECTION AND OTHER ‘‘93.102(a)’’ would be added in their d. In paragraph (a)(2)(i), the reference REQUIREMENTS FOR CERTAIN place; to ‘‘§ 92.106(c)’’ would be removed and ANIMALS; INSPECTION AND OTHER j. In paragraph (c)(3)(iv), the reference a reference to ‘‘§ 93.106(c)’’ would be REQUIREMENTS FOR CERTAIN to ‘‘§ 92.106(a)’’ would be removed and added in its place; and MEANS OF CONVEYANCE AND a reference to ‘‘93.106(a)’’ would be e. In paragraph (a)(2)(v), the reference SHIPPING CONTAINERS THEREON added in its place; to ‘‘§ 92.101 (b)(3)(i)(G) and (b)(3)(i)(J)’’ k. In paragraph (c)(3)(v), the reference would be removed and a reference to to ‘‘§ 92.210 (b) and (c)’’ would be 4. The authority citation for part 93 ‘‘§ 93.101 (b)(3)(i)(G) and (b)(3)(i)(J)’’ removed and a reference to ‘‘§ 93.210(b) would continue to read as follows: would be added in its place, and the and (c)’’ would be added in its place; Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; reference to ‘‘§ 92.101 (b)(3)(i)(B) and 21 U.S.C. 102–105, 111, 114a, 134a, 134b, l. In paragraph (d), the introductory text, the reference to ‘‘§ 92.103’’ would (b)(3)(i)(C)’’ would be removed and a 134c, 134d, 134f, 135, 136, and 136a; 31 reference to ‘‘§ 93.101(b)(3)(i)(B) and U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.2(d). be removed and a new references ‘‘§ 93.103’’ would be added in its place; (b)(3)(i)(C)’’ would be added in its place. 5. The heading for part 93 would be m. In paragraph (d)(1)(ii), the revised to read as set forth above. § 93.104 [Amended] reference to ‘‘§ 92.103(c)’’ would be 9. Newly designated § 93.104 would removed and a reference to Subpart A—Birds be amended as follows: ‘‘§ 93.103(c)’’ would be added in its § 93.101 [Amended] a. In paragraph (a), the reference to place; ‘‘§ 92.101 (b) and (c)’’ would be removed n. In paragraph (e), the reference to 6. Newly designated § 93.101 would and a reference to ‘‘§ 93.101 (b) and (c)’’ ‘‘§§ 92.102(a), 92.103, 92.104, 92.105(a), be amended as follows: would be added in its place; and 92.106(a)’’ would be removed and a. In paragraph (b)(1), the reference to b. In paragraph (c)(14), the reference a reference to ‘‘§§ 93.102(a), 93.103, ‘‘§§ 92.205, 92.214, and 92.216’’ would to ‘‘§ 92.101(b)(3)(i)(B)’’ would be 93.104, 93.105(a), and 92.106(a)’’ would be removed and a reference to removed and a reference to ‘‘§§ 93.205, 93.214, and 93.216’’ would be added in its place; and o. In paragraph (f), the reference to ‘‘§ 93.101(b)(3)(i)(B)’’ would be added in be added in its place; its place, and the reference to b. In paragraph (b)(3)(i)(B), the ‘‘§ 92.102 or 92.203’’ would be removed and a reference to ‘‘§ 93.102 or 93.203’’ ‘‘§ 92.101(b)(3)(i)(C)’’ would be removed reference to ‘‘§ 92.103(a)(2)(iv)’’ would and a reference to ‘‘§ 93.101(b)(3)(i)(C)’’ be removed, and a reference to would be added in its place; and the reference to ‘‘§ 92.103’’ would be would be added in its place; ‘‘§ 93.103(a)(2)(iv)’’ would be added in c. In paragraph (d)(9), the reference to its place; removed and a reference to ‘‘§ 93.103’’ added in its place. ‘‘§ 92.101(b)(2)(iii)(I)’’ would be c. In paragraph (b)(3)(i)(I), the removed and a reference to reference to ‘‘§ 92.103(a)(2)(iv)’’ would § 93.102 [Amended] ‘‘§ 93.101(b)(2)(iii)(I)’’ would be added be removed, and a reference to 7. Newly designated § 93.102 would in its place; and ‘‘§ 93.103(a)(2)(iv)’’ would be added in be amended as follows: d. In paragraph (d)(10), the reference its place; a. In paragraph (a), the reference to to ‘‘§ 92.101(b)(3)(i)(B)’’ would be d. In paragraph (b)(3)(i)(J), the ‘‘§ 92.101(c)’’ would be removed and a removed and a reference to reference to ‘‘§ 92.104(a)’’ would be reference to ‘‘§ 93.101(c)’’ would be ‘‘§ 93.101(b)(3)(i)(B)’’ would be added in removed, and a reference to added in its place, and the reference to its place, and the reference to ‘‘§ 93.104(a)’’ would be added in its ‘‘§ 92.101(f)’’ would be removed and a ‘‘§ 92.101(b)(3)(i)(C)’’ would be removed place; reference to ‘‘§ 93.101(f)’’ would be and a reference to ‘‘§ 93.101(b)(3)(i)(C)’’ e. In paragraph (b)(3)(i)(K), the added in its place; would be added in its place. reference to ‘‘§ 92.104(a)’’ would be b. In paragraph (c), the reference to removed, and a reference to ‘‘§ 92.105(a)’’ would be removed and a § 93.105 [Amended] ‘‘§ 93.104(a)’’ would be added in its reference to ‘‘§ 93.105(a)’’ would be 10. In newly designated § 93.105, place; added in its place; and paragraph (b) would be amended as f. In paragraph (c)(1), the reference to c. In paragraph (d), the reference to follows: ‘‘§§ 92.102 or 92.203’’ would be ‘‘§ 92.101(c) (1) or (2)’’ would be a. The reference to ‘‘§ 92.101(c)(2)’’ removed and a reference to ‘‘§§ 93.103 removed and a reference to would be removed both times it appears or 93.203’’ would be added in its place, ‘‘§ 93.101(c)(1) or (2)’’ would be added and a reference to ‘‘§ 93.101(c)(2) would and the reference to ‘‘§ 92.105’’ would in its place. be added in its place; Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17043

b. The reference to ‘‘§ 92.102(a)’’ ‘‘§ 92.209’’ and adding in its place a removed and a reference to ‘‘§ 93.204’’ would be removed and a reference to reference to ‘‘§ 93.209’’. would be added in its place, and the ‘‘§ 93.102(a)’’ would be added in its reference to ‘‘§ 92.201’’ would be place; and § 93.201 [Amended] removed and a reference to ‘‘§ 93.201’’ c. The reference to ‘‘§ 92.102 and 15. Newly designated § 93.201 would would be added in its place. 92.203’’ would be removed and a be amended as follows: reference to ‘‘§§ 93.102 and 93.203’’ a. In paragraph (b), the introductory § 93.216 [Amended] would be added in its place. text, the reference to ‘‘part 92’’ would be 22. Newly designated § 93.216 would removed and a reference to ‘‘part 93’’ be amended by removing the reference § 93.106 [Amended] would be added in its place, and the to ‘‘§ 92.209’’ and adding in its place a 11. Newly designated § 93.106 would reference to ‘‘§ 92.204’’ would be reference to ‘‘§ 93.209’’. be amended as follows: removed and a reference to ‘‘§ 93.204’’ 23. In subpart B, footnote 7 would be a. In paragraph (a), the reference to would be added in its place; amended by removing the reference to ‘‘§ 92.101(c)’’ would be removed and a b. In paragraph (b)(1)(ii), the reference ‘‘§ 92.217’’ and adding in its place a reference to ‘‘§ 93.101(c)’’ would be to ‘‘§ 92.204(c)’’ would be removed and reference to ‘‘§ 93.217’’. added in its place, and the reference to a reference to ‘‘§ 93.204(c)’’ would be § 93.217 [Amended] ‘‘§ 92.103’’ would be removed and a added in its place; and reference to ‘‘§ 93.103’’ would be added c. In paragraph (c), the reference to 24. Newly designated § 93.217 would in its place; ‘‘§ 92.203’’ would be removed and a be amended as follows: b. In paragraph (b)(1), the reference to reference to ‘‘§ 93.203’’ would be added a. In paragraph (a), the reference to ‘‘§ 92.103’’ would be removed and a in its place, and the reference to ‘‘§ 92.204’’ would be removed and a reference to ‘‘§ 93.103’’ would be added ‘‘§ 92.204’’ would be removed and a reference to ‘‘§ 93.204’’ would be added in its place; reference to ‘‘§ 93.204’’ would be added in its place; c. In paragraph (c)(2)(ii)(L), the in its place. b. In paragraph (b), the reference to ‘‘§ 92.206’’ would be removed and a reference to ‘‘§ 92.103’’ would be § 93.204 [Amended] removed and a reference to ‘‘§ 93.103’’ reference to ‘‘§ 93.206’’ would be added would be added in its place; 16. In newly designated § 93.204, in its place; and d. In paragraph (c)(2)(ii)(M), the paragraph (a)(1) would be amended by c. In paragraph (c), the reference to reference to ‘‘§ 92.103’’ would be removing the reference to ‘‘§§ 92.204(c), ‘‘§§ 92.205, 92.207, 92.209, and 92.210’’ removed and a reference to ‘‘§ 93.103’’ 92.214, 92.217, and 92.218’’ and adding would be removed and a reference to would be added in its place; in its place a reference to ‘‘§§ 93.204(c), ‘‘§ 93.205, 93.207, 93.209, and 93.210’’ e. In the ‘‘Cooperative and Trust Fund 93.214, 93.217, and 93.218’’. would be added in its place. 25. In subpart B, footnote 8 would be Agreement,’’ paragraph (A)(5), the § 93.207 [Amended] reference to ‘‘§ 92.106(c)’’ would be amended by removing the reference to 17. Newly designated § 93.207 would ‘‘§§ 92.218 to 92.220’’ and adding in its removed and a reference to be amended by removing the reference ‘‘§ 93.106(c)’’ would be added in its place a reference to ‘‘§§ 93.218 to to ‘‘§§ 92.215 and 92.220’’ and adding in 93.220’’. place; its place a reference to ‘‘§§ 93.215 and f. In the ‘‘Cooperative and Trust Fund 93.220’’. § 93.218 [Amended] Agreement,’’ paragraph (A)(13), the 26. In newly designated § 93.218, § 93.209 [Amended] reference to ‘‘§ 92.106(c)(3)(ii)(C)’’ paragraph (a) would be amended by would be removed and a reference to 18. In newly designated § 93.209, removing the reference to ‘‘§ 92.204’’ ‘‘§ 93.106(c)(3)(ii)(C)’’ would be added paragraph (a)(1) would be amended by and adding in its place a reference to in its place; and removing the reference to ‘‘§ 92.216’’ ‘‘§ 93.204’’. g. In the ‘‘Cooperative and Trust Fund and adding in its place a reference to Agreement,’’ paragraph (A)(20), the ‘‘§ 93.216’’. § 93.219 [Amended] reference to ‘‘§ 92.106(c)’’ would be 19. In subpart B, footnote 6 would be 27. Newly designated § 93.219 would removed and a reference to amended by removing the reference to be amended by removing the reference ‘‘§ 93.106(c)’’ would be added in its ‘‘§§ 92.214 to 92.216’’ and adding in its to ‘‘§ 92.206’’ and adding in its place a place. place a reference to ‘‘§§ 93.214 to reference to ‘‘§ 93.206’’. 12. In subpart A, footnote 13 would be 93.215’’. amended by removing the reference to § 93.220 [Amended] ‘‘§ 92.107’’ and adding in its place a § 93.214 [Amended] 28. In newly designated § 93.220, reference to ‘‘§ 93.107’’. 20. Newly designated § 93.214 would paragraph (b) would be amended by be amended as follows: removing the reference to ‘‘§ 92.203’’ § 93.107 [Amended] a. In paragraph (a), the reference to and adding in its place a reference to 13. Newly designated § 93.107 would ‘‘§ 92.204’’ would be removed and a ‘‘§ 93.203’’. be amended by removing the reference reference to ‘‘§ 93.204’’ would be added to ‘‘§ 92.103’’ and adding in its place a in its place, and the reference to Subpart CÐHorses reference to ‘‘§ 93.103’’, and by ‘‘§ 92.203(b)’’ would be removed and a § 93.301 [Amended] removing the reference to ‘‘§ 92.101’’ reference to ‘‘§ 93.203(b)’’ would be and adding in its place a reference to added in its place; and 29. Newly designated § 93.301 would ‘‘§ 93.101’’. b. In paragraph (b), the reference to be amended as follows: ‘‘§ 92.206’’ would be removed and a a. In paragraph (b), the reference to Subpart BÐPoultry reference to ‘‘§ 93.206’’ would be added ‘‘§ 92.304’’ would be removed and a in its place. reference to ‘‘§ 93.304’’; § 93.200 [Amended] b. In paragraph (c)(2)(i), the reference 14. In newly designated § 93.200, the § 93.215 [Amended] to ‘‘§ 92.301(a)’’ would be removed and definition of Operator would be 21. In newly designated § 93.215(a)(1), a reference to ‘‘§ 93.301(a)’’ would be amended by removing the reference to the reference to ‘‘§ 92.204’’ would be added in its place; 17044 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

c. In paragraph (c)(2)(ii), the reference be removed and a reference to e. In paragraph (a)(4)(i), the reference to ‘‘§ 92.314’’ would be removed and a ‘‘§ 93.304(a)(5)(iii)’’ would be added in to ‘‘§ 92.301(c)(1)’’ would be removed reference to ‘‘§ 93.314’’ would be added its place; and a reference to ‘‘§ 93.301(c)(1)’’ in its place; r. In paragraph (c)(2)(x), the reference would be added in its place, and the d. In paragraph (c)(2)(iii), the to ‘‘§ 92.304(a)’’ would be removed and reference to ‘‘§ 92.301(c)(2)(iv) or reference to ‘‘§ 92.304’’ would be a reference to ‘‘§ 93.304(a)’’ would be § 92.301(c)(2)(ix)’’ would be removed removed and a reference to ‘‘§ 93.304’’ added in its place, the reference to and a reference to ‘‘§ 93.301(c)(2)(iv) or would be added in its place; ‘‘§ 92.304(a)(7)(ii)’’ would be removed § 93.301(c)(2)(ix)’’ would be added in its e. In paragraph (c)(2)(iv), introductory and a reference to ‘‘§ 93.304(a)(7)(ii)’’ place; text, the reference to ‘‘§ 92.304’’ would would be added in its place, and the f. In paragraph (a)(4)(ii), the reference be removed and a reference to reference to ‘‘§ 92.304(a)(8)(iii)’’ would to ‘‘§ 92.301(c)(2)(iv) and ‘‘§ 93.304’’ would be added in its place, be removed and a reference to § 92.301(c)(2)(ix)’’ would be removed and the reference to ‘‘§ 92.314’’ would ‘‘§ 93.304(a)(8)(iii)’’ would be added in and a reference to ‘‘§§ 93.301(c)(2)(iv) be removed and a reference to its place; and 93.301(c)(2)(ix)’’ would be added in ‘‘§ 93.314’’ would be added in its place; s. The second paragraph its place; f. In paragraph (c)(2)(v)(A)(1), the (c)(2)(xi)(C)(2) would be redesignated as g. In paragraph (a)(5)(ii)(A), the reference to ‘‘§ 92.304’’ would be paragraph (c)(2)(xi)(C)(3); reference to ‘‘§ 92.301(c)(1)’’ would be removed and a reference to ‘‘§ 93.304’’ t. In newly designated paragraph removed and a reference to would be added in its place; (c)(2)(xi)(C)(3), the reference to ‘‘§ 93.301(c)(1)’’ would be added in its g. In paragraph (c)(2)(v)(A)(2), the ‘‘§ 92.304’’ would be removed and a place, and the reference to reference to ‘‘§ 92.314’’ would be reference to ‘‘§ 93.304’’ would be added ‘‘§ 92.301(c)(2)(iv) or § 92.301(c)(2)(ix)’’ removed and a reference to ‘‘§ 93.314’’ in its place; and would be removed and a reference to would be added in its place; u. In paragraph (c)(2)(xi)(E), the ‘‘§ 93.301(c)(2)(iv) or § 93.301(c)(2)(ix)’’ h. In paragraph (c)(2)(v)(G), the reference to ‘‘§ 92.308(a), (b), and (c)’’ would be added in its place; reference to ‘‘§ 92.401(c)(2)(v)’’ would would be removed and a reference to h. In paragraph (a)(5)(iii), introductory be removed and a reference to ‘‘§ 93.308 (a), (b), and (c)’’ would be text, the reference to ‘‘§ 92.301(c)(1)’’ ‘‘§ 93.401(c)(2)(v)’’ would be added in added in its place. would be removed and a reference to its place; ‘‘§ 93.301(c)(1)’’ would be added in its i. In paragraph (c)(2)(vi)(A)(1), the § 93.303 [Amended] place, and the reference to reference to ‘‘§ 92.304’’ would be 30. Newly designated § 93.303 would ‘‘§ 92.301(c)(2)(iv) or § 92.301(c)(2)(ix)’’ removed and a reference to ‘‘§ 93.304’’ be amended as follows: would be removed and a reference to would be added in its place; a. In paragraph (a), the reference to ‘‘§ 93.301(c)(2)(iv) or § 93.301(c)(2)(ix)’’ j. In paragraph (c)(2)(vi)(A)(2), the ‘‘§§ 92.308 (a), (b), and (c) and 92.317’’ would be added in its place; reference to ‘‘§ 92.314’’ would be would be removed and a reference to i. In paragraph (a)(7)(i), the reference removed and a reference to ‘‘§ 93.314’’ ‘‘§§ 93.308 (a), (b), and (c) and 93.317’’ to ‘‘§ 92.301(c)(1)’’ would be removed would be added in its place; would be added in its place; and k. In paragraph (c)(2)(vi)(E), the b. In paragraph (e), the reference to and a reference to ‘‘§ 93.301(c)(1)’’ reference to ‘‘§ 92.308’’ would be ‘‘§§ 92.301(c), 92.304(a), 92.306, 92.308 would be added in its place, and the removed and a reference to ‘‘§ 93.308’’ (a), (b), and (c), and 92.314’’ would be reference to ‘‘§ 92.301(c)(2)(v), would be added in its place; removed and a reference to § 92.301(c)(2)(vi), § 92.301(c)(2)(vii) or l. In paragraph (c)(2)(vi)(G), the ‘‘§§ 93.301(c), 93.304(a), 93.306, 93.308 § 92.301(c)(2)(x)’’ would be removed reference to ‘‘§ 92.304(a)’’ would be (a), (b), and (c), and 93.314’’ would be and a reference to ‘‘§ 93.301(c)(2)(v), removed and a reference to added in its place. § 93.301(c)(2)(vi), § 93.301(c)(2)(vii) or ‘‘§ 93.304(a)’’ would be added in its § 93.301(c)(2)(x)’’ would be added in its place; § 93.304 [Amended] place; m. In paragraph (c)(2)(vii)(A), the 31. Newly designated § 93.304 would j. In paragraph (a)(7)(ii), the reference reference to ‘‘§ 92.304’’ would be be amended as follows: to ‘‘§ 92.301(c)(2)(v), § 92.301(c)(2)(vi), removed and a reference to ‘‘§ 93.304’’ a. In paragraph (a)(1)(i), the reference § 92.301(c)(2)(vii) and § 92.301(c)(2)(x)’’ would be added in its place; to ‘‘§ 92.301(c)(1)’’ would be removed would be removed and a reference to n. In paragraph (c)(2)(vii)(B), the and a reference to ‘‘§ 93.301(c)(1)’’ ‘‘§§ 93.301(c)(2)(v), 93.301(c)(2)(vi), reference to ‘‘§ 92.314’’ would be would be added in its place, and the 93.301(c)(2)(vii) and 93.301(c)(2)(x)’’ removed and a reference to ‘‘§ 93.314’’ reference to ‘‘§§ 92.315, 92.319, and would be added in its place; would be added in its place; 92.321’’ would be removed and a k. In paragraph (a)(8), introductory o. In paragraph (c)(2)(viii)(A), the reference to ‘‘§§ 93.315, 93.319, and text, the reference to ‘‘§ 92.301(c)(2)(v), reference to ‘‘§ 92.304’’ would be 93.321’’ would be added in its place; § 92.301(c)(2)(vi), § 92.301(c)(2)(vii) or removed and a reference to ‘‘§ 93.304’’ b. In paragraph (a)(1)(ii), introductory § 92.301(c)(2)(x)’’ would be removed would be added in its place; text, the two references to and a reference to ‘‘§ 93.301(c)(2)(v), p. In paragraph (c)(2)(viii)(E), the ‘‘§ 92.301(c)(2)(viii)’’ would be removed § 93.301(c)(2)(vi), § 93.301(c)(2)(vii) or reference to ‘‘§ 92.304’’ would be and references to ‘‘§ 93.301(c)(2)(viii)’’ § 93.301(c)(2)(x)’’ would be added in its removed and a reference to ‘‘§ 93.304’’ would be added in their place; place; would be added in its place; c. In paragraph (a)(1)(iii), the l. In paragraph (a)(8)(ii), the reference q. In paragraph (c)(2)(ix), the reference reference to ‘‘§ 92.301(c)(2)(viii)’’ would to ‘‘§ 92.301(c)(1)’’ would be removed to ‘‘§ 92.304(a)’’ would be removed and be removed and a reference to and a reference to ‘‘§ 93.301(c)(1)’’ a reference to ‘‘§ 93.304(a)’’ would be ‘‘§ 93.301(c)(2)(viii)’’ would be added in would be added in its place, and the added in its place, the reference to its place; reference to ‘‘§ 92.301(c)(2)(v), ‘‘§ 92.304(a)(4)(ii)’’ would be removed d. In paragraph (a)(2), the reference to § 92.301(c)(2)(vi), § 92.301(c)(2)(vii) or and a reference to ‘‘§ 93.304(a)(4)(ii)’’ ‘‘§ 92.301(c)(1)’’ would be removed and § 92.301(c)(2)(x)’’ would be removed would be added in its place, and the a reference to ‘‘§ 93.301(c)(1)’’ would be and a reference to ‘‘§ 93.301(c)(2)(v), reference to ‘‘§ 92.304(a)(5)(iii)’’ would added in its place; § 93.301(c)(2)(vi), § 93.301(c)(2)(vii) or Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17045

§ 93.301(c)(2)(x)’’ would be added in its reference to ‘‘§ 93.303’’ would be added reference to ‘‘§ 93.317(b)’’ would be place; in its place; added in its place. m. In paragraph (a)(8)(iii), b. In paragraph (a)(1), the reference to 40. In subpart C, footnote 19 would be introductory text, the reference to ‘‘§§ 92.317 and 92.324’’ would be amended by removing the reference to ‘‘§ 92.301(c)(1)’’ would be removed and removed and a reference to ‘‘§§ 93.317 ‘‘§§ 92.319 and 92.320’’ and adding in a reference to ‘‘§ 93.301(c)(1)’’ would be and 92.324’’ would be added in its its place a reference to ‘‘§§ 93.319 and added in its place, and the reference to place, and the reference to ‘‘§ 92.303’’ 93.320’’. ‘‘§ 92.301(c)(2)(v), § 92.301(c)(2)(vi), would be removed and a reference to § 93.319 [Amended] § 92.301(c)(2)(vii) or § 92.301(c)(2)(x)’’ ‘‘§ 93.303’’ would be added in its place; 41. Newly designated § 93.319 would would be removed and a reference to c. In paragraph (b), the reference to be amended by removing the reference ‘‘§ 93.301(c)(2)(v), § 93.301(c)(2)(vi), ‘‘§ 92.303(e)’’ would be removed and a to ‘‘§ 92.305’’ and adding in its place a § 93.301(c)(2)(vii) or § 93.301(c)(2)(x)’’ reference to ‘‘§ 93.303(e)’’ would be reference to ‘‘§ 93.305’’. would be added in its place; added in its place; and n. In paragraph (a)(8)(iii)(B), the d. In paragraph (c)(4)(ii), the reference § 93.320 [Amended] reference to ‘‘§ 92.301(c)(2)(vii)’’ would to ‘‘§ 92.308(a)’’ would be removed and 42. Newly designated § 93.320 would be removed and a reference to a reference to ‘‘§ 93.303(a)’’ would be be amended by removing the reference ‘‘§ 93.301(c)(2)(vii)’’ would be added in added in its place. to ‘‘§ 92.306’’ and adding in its place a its place; § 93.314 [Amended] reference to ‘‘§ 93.306’’, by removing the o. In paragraph (a)(8)(iii)(C), reference to ‘‘§ 92.314’’ and adding in its introductory text, the reference to 34. In newly designated § 92.314, the place a reference to ‘‘§ 93.314’’, and by ‘‘§ 92.304(a)(8)(iii)(B)’’ would be reference to ‘‘§ 92.301(c)(2) (i) through removing the reference to ‘‘§ 92.308 (a), removed and a reference to (viii)’’ would be removed and a (b) and (c)’’ and adding in its place a ‘‘§ 93.301(a)(8)(iii)(B)’’ would be added reference to ‘‘§ 93.301(c)(2) (i) through reference to ‘‘§ 93.308 (a), (b), and (c)’’. in its place; (viii)’’ would be added in its place, and 43. In subpart C, footnote 20 would be p. In paragraph (a)(8)(iii)(D), the the reference to ‘‘§ 92.301(c)(1)’’ would amended by removing the reference to reference to ‘‘§ 92.301(c)(1)’’ would be be removed and a reference to ‘‘§§ 92.321 to 92.326’’ and adding in removed and a reference to ‘‘§ 93.301(c)(1) would be added in its their place a reference to ‘‘§§ 93.321 to ‘‘§ 93.301(c)(1)’’ would be added in its place. 93.326’’. place, the reference to ‘‘§ 92.301(c)(2)(v) 35. In subpart C, footnote 18 would be or § 92.301(c)(2)(vii)’’ would be removed amended by removing the reference to § 93.322 [Amended] and a reference to ‘‘§ 93.301(c)(2)(v) or ‘‘§§ 92.315, 92.316, 92.317 and 92.318’’ 44. Newly designated § 93.322 would § 93.301(c)(2)(vii)’’ would be added in would be removed and a reference to be amended by removing the reference its place, and the reference to ‘‘§§ 93.315, 93.316, 93.317 and 93.318’’ to ‘‘§ 92.305’’ and adding in its place a ‘‘§ 92.301(c)(2)(v)(G), would be added in its place. reference to ‘‘§ 93.305’’. § 92.301(c)(2)(vi)(F), or § 93.323 [Amended] § 92.301(c)(2)(vi)(G)’’ would be removed § 93.315 [Amended] and a reference to ‘‘§ 93.301(c)(2)(v)(G), 36. Newly designated § 93.315 would 45. In newly designated § 93.323, § 93.301(c)(2)(vi)(F), or be amended by removing the reference paragraphs (a) and (b) would be § 93.301(c)(2)(vi)(G)’’ would be added in to ‘‘§ 92.305’’ and adding in its place a amended by removing the references to its place; reference to ‘‘§ 93.305’’. ‘‘§ 92.324’’ and adding in their place a q. In paragraph (a)(8)(iii)(E), the reference to ‘‘§ 93.324’’. § 93.316 [Amended] reference to ‘‘§ 92.301(c)(1)’’ would be § 93.324 [Amended] 37. Newly designated § 93.316 would removed and a reference to 46. Newly designated § 93.324 would be amended by removing the reference ‘‘§ 93.301(c)(1)’’ would be added in its be amended by removing the reference to ‘‘§ 92.306’’ and adding in its place a place, and the reference to to ‘‘§ 92.303(a)’’ and adding in its place reference to ‘‘§ 93.306’’. ‘‘§ 92.301(c)(2)(vii) or § 92.301(c)(2)(x)’’ a reference to ‘‘§ 93.303(a)’’. would be removed and a reference to § 93.317 [Amended] ‘‘§ 93.301(c)(2)(vii) or § 93.301(c)(2)(x)’’ § 93.325 [Amended] would be added in its place; and 38. In newly designated § 93.317(a), 47. Newly designated § 93.325 would r. In paragraph (b), the reference to the reference to ‘‘§ 92.306’’ would be be amended by removing the reference ‘‘§ 92.301(c)(1)’’ would be removed and removed and a reference to ‘‘§ 93.306’’ to ‘‘§§ 92.306 and 92.323’’ and adding in a reference to ‘‘§ 93.301(c)(1)’’ would be would be added in its place, and the its place a reference to ‘‘§§ 93.306 and added in its place. reference to ‘‘§ 92.314’’ would be 92.323’’, by removing the reference to removed both times it appears and a ‘‘§ 92.314’’ and adding in its place a § 93.306 [Amended] reference to ‘‘§ 93.314’’ would be added reference to ‘‘93.314’’, and by removing 32. In newly designated § 93.306, each time in its place. the reference to ‘‘§ 92.324’’ and adding paragraph (a) would be amended by § 93.318 [Amended] in its place a reference to ‘‘§ 93.324’’. removing the reference to ‘‘§§ 92.318 and 92.323’’ and adding in its place a 39. Newly designated § 93.318 would § 93.326 [Amended] reference to ‘‘§§ 93.318 and 93.323’’. be amended as follows: 48. Newly designated § 93.326 would a. In paragraph (a)(1), the reference to be amended by removing the reference § 93.308 [Amended] ‘‘§ 92.304’’ would be removed and a to ‘‘§§ 92.321, 92.322, 92.323’’ and 33. Newly designated § 92.308 would reference to ‘‘§ 93.304’’ would be added adding in its place a reference to be amended as follows: in its place, and the reference to ‘‘§§ 93.321, 93.322, and 93.323’’, and by a. In paragraph (a), the reference to ‘‘§ 92.301’’ would be removed and a removing the reference to ‘‘§ 92.324’’ the ‘‘§ 92.324’’ would be removed and a reference to ‘‘§ 93.301’’ would be added second time it appears and adding in its reference to ‘‘§ 93.324’’ would be added in its place; and place a reference to ‘‘§ 93.324’’. in its place, and the reference to b. In paragraph (b), the reference to 49. Subparts D and E would be ‘‘§ 92.303’’ would be removed and a ‘‘§ 92.317(b)’’ would be removed and a revised to read as follows: 17046 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

Subpart DÐRuminants a communicable disease agent, or that Depending on the condition, this may Sec. are not known to be infected, infested, be an animal with clinical signs, or an 93.400 Definitions. or exposed but that because of animal with serological or pathological 93.401 General prohibitions; exceptions. information, proximity, location, evidence of infection, or an infested 93.402 Inspection of certain aircraft and season, or lack of surveillance data animal. other means of conveyance and shipping could reasonably be expected to be Cattle. Animals of the bovine species. containers thereon; unloading, cleaning, infected, infested, or exposed to a Communicable disease. Any and disinfection requirements. contagious or infectious disease of 93.403 Ports designated for the importation communicable disease agent. of ruminants. Affected premises or region. A animals. It can be transmitted either 93.404 Import permits for ruminants and premises or region where a directly or indirectly to a susceptible for ruminant specimens for diagnostic communicable disease agent is known animal from an infected animal, vector, purposes; and reservation fees for space to exist; that is adjacent to or proximate inanimate reservoir, or other source. at quarantine facilities maintained by to any known infected or infested Contagious disease. Any APHIS. premises or region so that airborne, communicable disease transmitted from 93.405 Certificate of export and other vector, or mechanical transmission of one animal to another. Such requirements for ruminants. the disease agent could occur; or that, transmission includes, but is not limited 93.406 Permit, certificate, declaration and to, contact with other animals or by other documents for ruminants. because of lack of surveillance data, 93.407 Inspection at the port of entry. could reasonably be expected to be feed, water, aerosol, or contaminated 93.408 Articles accompanying ruminants. infected, infested, or exposed to a objects. 93.409 Movement from conveyances to communicable disease agent. Department. The United States quarantine station. Animal and Plant Health Inspection Department of Agriculture (USDA). 93.410 Ruminant quarantine facilities. Service (APHIS). The Animal and Plant Driven. Moved (animals) from one 93.411 Quarantine stations, visiting Health Inspection Service of the United place to another by walking under their restricted; sales prohibited. States Department of Agriculture. own power and being herded and 93.412 Milk from quarantined ruminants. Animals. All species of the animal guided by persons or trained animals. 93.413 Manure from quarantined kingdom including: Cattle, sheep, goats, Ectoparasites. Acarid (mites, ticks) or ruminants. insect members of the Phylum 93.414 Appearance of disease among other ruminants, swine, horses, asses, ruminants in quarantine. mules, zebras, dogs, and poultry that are Arthropoda that spend all or part of 93.415 Requirements for importation of live susceptible to communicable diseases of their life cycle on the exterior of avian, ruminants from various risk class livestock or capable of being carriers of reptilian or mammalian hosts and that regions. those diseases or their arthropod are known or suspected to be the vectors 93.416 Importation of ruminants through vectors. of communicable disease agents, or are the Harry S. Truman Animal Import APHIS representative. Any individual the cause of disease or irritation in Center (HSTAIC). employed by the Animal and Plant animals or birds. 93.417 Pre-embarkation quarantine facility; Equivalent test. A serologic, criteria and standards for approval. Health Inspection Service, United States Department of Agriculture, who is microbiologic, chemical, or physical test Subpart DÐRuminants authorized to perform the services approved for use in a region exporting required by this part. livestock or livestock products to the § 93.400 Definitions. Approved bovine tuberculosis test. United States and recognized by the Wherever in this subpart the Any test recognized as an Official Administrator as providing results equal following terms are used, unless the tuberculosis test in the United States to a test approved by the United States context otherwise requires, they shall be according to § 77.1 of this chapter or a Department of Agriculture. Recognition construed, respectively, to mean: test recognized as an equivalent test by of a test as an ‘‘equivalent test’’ will be Accredited veterinarian. A the Administrator and that is recognized made by the Administrator after he or veterinarian approved by the as an official test in a country exporting she reviews scientific data that shows Administrator in accordance with part animals to the United States. that the results of the test are equal to 161 of this chapter to perform functions Approved brucellosis test. Any test the USDA-approved test. specified in parts 1, 2, 3, and 11 of recognized as an official brucellosis test Exposed. (1) An animal or means of subchapter A, and subchapters B, C, and in the United States according to § 78.1 conveyance that has been in contact D of this chapter, and to perform of this chapter, or a test recognized as with or that can reasonably be expected functions required by cooperative State- an equivalent test by the Administrator to have been in contact with an animal, Federal disease control and eradication and that is recognized as an official test feed, water, air, soil, tools, or other programs. in a country exporting animals to the objects, insects, or ectoparasites infected Adjacent regions. Any defined United States. or contaminated with a communicable geographic land area identifiable by Approved tests for restricted diseases disease agent, as determined by the geological, political or surveyed or agents. Diagnostic tests or procedures Administrator. boundaries that shares common that are determined by the (2) A region or premises where an boundaries with, or is proximate to any Administrator to be scientifically valid animal, feed, water, air, soil, tools or region of a different risk class, as to diagnose a restricted animal disease. other objects, insects, or ectoparasites determined by the Administrator. Authorized veterinarian. A contaminated with a communicable Administrator. The Administrator of veterinarian accredited, employed or disease agent are or have been present the Animal and Plant Health Inspection authorized by the National Veterinary within the known incubation period for Service or any other employee of the Services of the country to carry out the the disease agent. Animal and Plant Health Inspection required inspection and certification (i) Direct exposure. Exposure by Service, United States Department of services. coming into direct contact with an Agriculture, delegated to act in the Border definitions. See § 92.1 of this infected animal, or with feed, water, air, Administrator’s stead. chapter. soil, tools, or other objects, that have Affected animals. Animals currently Case. An individual animal affected been contaminated by discharges from infected or infested with, or exposed to, by a communicable disease agent. an infected animal. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17047

(ii) Indirect exposure. Exposure by which cannot be reused if opened, or a Shipping container. For the purposes coming into contact with vector insects serially numbered, self-locking button of § 93.402, any container of a type or ectoparasites, or objects that have which can be used for this purpose. specially adapted for use in transporting been contaminated other than by Operator. Any person operating an any article on the means of conveyance discharges from an infected animal. approved quarantine facility. involved. Herd. (1) A group of animals under Permitted treatment. A treatment Susceptible animals. Species of common ownership or supervision that authorized by the Administrator to be ruminants or other animals that can are maintained and intermingle on one used in the official treatment of animals become infected with a specific disease or more parts of a single premises (farm, for control or removal of ectoparasites. agent. ranch, feedlot, etc.); or Person. Any individual, corporation, Trail. Move animals from one place to (2) A group of animals under common company, association, firm, partnership, another by having them walk under ownership or supervision maintained society, joint stock company, or other their own power, and by leading them on geographically separated premises legal entity. by ropes or other devices tied to the but that have been interchanged Port Veterinarian. A veterinarian animal and guided by persons or trained between the different premises or have employed by APHIS to perform duties animals. been otherwise intermingled. required under this part at a port of Transported. Moved or shipped from Identification. (1) Permanent entry. one place to another by any means of identification. Brands, tattoos, or Post-importation quarantines. conveyance, such as airplane, ship, electronic identification that cannot be Quarantines applied in the importing boat, barge, truck, train, cart, or other readily removed or altered. region at a facility specially designated vehicle. (2) Semi-permanent identification. as an import quarantine facility. United States. All of the States of the Identification such as metal or plastic Pre-embarkation quarantines. United States, the District of Columbia, ear tags that may remain on an animal Quarantines applied in the exporting Guam, the Northern Mariana Islands, permanently but can be easily altered, region. May be on the premises of Puerto Rico, the Virgin Islands of the lost or removed. origin, a separate quarantine facility, a United States, and all other Territories (3) Non-permanent identification. border station, or other facility used to and Possessions of the United States. Identification such as temporary ear hold animals while in transit. Vector-borne disease. A disease tags, chain tags, back tags, or tail tags. Quarantine. Confinement of all transmitted indirectly to an animal (4) Temporary identification. Lot susceptible animals, animal products, through an intermediate arthropod identification if lots are not mixed, or feed, farm machinery, other equipment, vector, including ticks or insects. Veterinarian in Charge. The the origin of all lots in a mixed lot. means of conveyance, and any other veterinary official of the Animal and Immediate slaughter. Consignment potentially contaminated objects to a Plant Health Inspection Service, United directly from the port of entry to a premises or area where infection or 1 States Department of Agriculture, who recognized slaughtering establishment infestation with a specific restricted is assigned by the Administrator to and slaughter thereat within two weeks agent has been found or is suspected to supervise and perform the official from the date of entry. exist. Import (imported, importation) into animal health work of the Animal and Recognized slaughtering the United States. To bring into the Plant Health Inspection Service in the establishment. An establishment 2 where territorial limits of the United States. State or area concerned. slaughtering operations are regularly Inspector. An employee of the Animal Wether. A castrated male sheep or carried on under Federal or State and Plant Health Inspection Service goat. inspection and that has been approved authorized to perform duties required Zoological park. A zoo, park, garden by APHIS to receive animals for under this subpart. or other place, maintained under the slaughter under this part. Livestock. Domesticated species of surveillance of a licensed Doctor of cattle, swine, sheep, goats, llamas, Region. Any defined geographic land Veterinary Medicine, for the exhibition horses, or poultry that normally and region identifiable by geological, of live animals, pigeons or birds, for the historically have been kept and raised political or surveyed boundaries. purpose of public recreation or on farms. Livestock also includes bison Restricted agents. A livestock education. and cervidae or other species kept in communicable disease agent, vector, or § 93.401 General prohibitions; exceptions. captivity for producing food or fiber, or host of an agent not known to exist in for other commercial purposes. the United States or that is subject to (a) No ruminant subject to the Moved directly. Moved (shipped, Federal or cooperative Federal/State provisions of this part may be imported transported, other otherwise moved) control or eradication program within into the United States except in without unloading and without the United States. Restricted agents are accordance with the regulations in this stopping except for refueling, or for listed in § 92.2 of this chapter. part, nor may any such ruminant be traffic conditions such as traffic lights or Risk Class regions. Exporting regions handled or moved after physical entry stop signs. designated by the Administrator into the United States before final Official seal. A serially numbered, according to the results of a risk release from quarantine or any other metal or plastic strip, consisting of a assessment as defined in § 92.1 of this form of Federal governmental detention self-locking device on one end and a chapter, and determined by criteria as except in compliance with such slot on the other end, which forms a set forth in § 92.3 of this chapter, are regulations; Provided that: Except as loop when the ends are engaged and incorporated herein and are applicable prohibited by section 306 of the Act of to this part. June 17, 1930, as amended (19 U.S.C. 1 The name of recognized slaughtering Ruminants. All animals that chew the 1306), the Administrator may, upon establishments approved under this part may be cud, such as cattle, buffaloes, sheep, request in specific cases, allow obtained from the Area Veterinarian in Charge goats, deer, antelopes, camels, llamas ruminants to be brought into or through (AVIC), Veterinary Services, Animal and Plant and giraffes. Health Inspection Service, for the State of the United States under such conditions destination of the shipment. AVIC telephone as he or she may prescribe, when he or numbers can be found in the local telephone book. 2 See footnote 1 in § 93.400. she determines in the specific case that 17048 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules such action will not endanger the such means of conveyance or in an or she deems it necessary to enable him livestock or poultry of the United States. approved holding facility during or her to determine whether the means (b) Except for ruminants prohibited transshipment as required by this of conveyance or container is in fact so entry by section 306 of the Act of June paragraph. contaminated. The principal operator of 17, 1930, as amended (19 U.S.C. 1306), (c) Provisions for the approval of the means of conveyance and his or her the provisions in this part relating to facilities required in this paragraph are: agent in charge of the means of ruminants shall not apply to healthy (1) They must be sufficiently isolated conveyance must comply with any such ruminants in transit through the United to prevent direct or indirect contact requirements under the immediate States if they are not known to be with all other animals and birds while supervision of, and in the time and infected with or exposed, within 60 in the United States. manner prescribed by, the inspector. days preceding the date of export from (2) They must be so constructed that (c) Cleaning and disinfection. the region of origin, to communicable they provide adequate protection Whenever, upon inspection under this diseases of ruminants, and if an import against environmental conditions and section, an inspector determines that a permit 3 has been properly applied for can be adequately cleaned, washed and means of conveyance or shipping and obtained under § 93.404 of this disinfected. container is contaminated with material chapter and all conditions therein are (3) They must provide for disposal of of animal origin so as to present a observed; and if the following ruminant carcasses, manure, bedding, danger of the spread of any conditions are also met: waste and any related shipping communicable animal disease, he or she (1)(i) The ruminants are maintained materials in a manner that will prevent shall notify the principal operator of the under continuous confinement in transit dissemination of disease. means of conveyance or his or her agent through the United States aboard an (4) They must have provisions for in charge, of such determination and the aircraft, ocean vessel, or other means of adequate sources of feed and water and requirements under this section. The conveyance; or for attendants for the care and feeding person so notified must cause the (ii) The ruminants are unloaded, in of ruminants in the facility. proper cleaning and disinfection of such the course of such transit, into a (5) They must comply with additional means of conveyance and container ruminant holding facility that is requirements as may be imposed by the under the immediate supervision of, provided by the carrier or its agent and Administrator if deemed applicable for and in the time and manner prescribed has been approved 4 in advance by the a particular shipment. by, the inspector. Administrator in accordance with (6) They must also comply with all paragraph (c) of this section as adequate applicable local, State and Federal § 93.403 Ports designated for the importation of ruminants. to prevent the spread within the United requirements for environmental quality States of any livestock disease, and the and with the provisions of the Animal (a) Air and ocean ports. The following ruminants are maintained there under Welfare Regulations in chapter I of this ports have APHIS inspection and continuous confinement until loaded title, as applicable. quarantine facilities necessary for aboard a means of conveyance for quarantine stations and all ruminants § 93.402 Inspection of certain aircraft and shall be entered into the United States transportation from the United States other means of conveyance and shipping and are maintained under continuous only through these stations, except as containers thereon; unloading, cleaning, otherwise provided in this section; confinement aboard such means of and disinfection requirements. conveyance until it leaves the United Miami, Florida; Honolulu, Hawaii; and (a) Inspection. All aircraft and other Newburgh, New York. States; the import permit will specify means of conveyance (including any additional conditions necessary to (b) Canadian border ports. The shipping containers thereon) moving following land border ports are ensure that the transit of the ruminants into the United States from any foreign through the United States can be made designated as having the necessary country are subject to inspection inspection facilities for the entry of without endangering the livestock or without a warrant by properly identified poultry of the United States, and that ruminants from Canada: Eastport, Idaho; and designated APHIS inspectors to Houlton and Jackman, Maine; Detroit, Department inspectors may inspect the determine whether they are carrying any ruminants on board such means of Port Huron, and Sault Ste. Marie, animal, carcass, product or article Michigan; Baudette, Minnesota; conveyance or in such holding facility regulated or subject to disposal under as provided in section 5 of the Act of Opheim, Raymond, and Sweetgrass, any law or regulation administered by Montana; Alexandria Bay, Buffalo, and July 2, 1962 (21 U.S.C. 134d) to the Secretary of Agriculture for ascertain whether the requirements of Champlain, New York; Dunseith, prevention of the introduction or Pembina, and Portal, North Dakota; this paragraph are met, and dispose of dissemination of any communicable them in accordance with section 2 of the Derby Line and Highgate Springs, animal disease (21 U.S.C. 134d). Vermont; Blaine, Lynden, Oroville, and Act of July 2, 1962 (21 U.S.C. 134a) if (b) Unloading requirements. such conditions are not met; and Sumas, Washington. Whenever in the course of any such (c) Mexican border ports. The (2) The carrier or its agent executes inspection at any port in the United following land border ports are and furnishes to the collector of U.S. States the APHIS inspector has reason to designated as having the necessary Customs at the first port of arrival in the believe that the means of conveyance or inspection facilities for the entry of United States a declaration stating that container is contaminated with material ruminants from Mexico: Brownsville, the ruminants will be retained aboard of animal origin, such as, but not Hidalgo, Laredo, Eagle Pass, Del Rio, limited to, meat, organs, glands, and Presidio, Texas; Douglas, Naco, 3 Such permit may be obtained from the National Center for Import and Export, Veterinary Services, extracts, secretions, fat, bones, blood, Nogales, Sasabe, and San Luis, Arizona; APHIS, 4700 River Road Unit 39, Riverdale, MD lymph, urine, or manure, so as to Calexico and San Ysidro, California; and 20737–1231. present a danger of the spread of any Antelope Wells, Columbus, and Santa 4 Requests for approval of ruminant holding communicable animal disease, the Teresa, New Mexico. facilities should be made to the National Center for Import and Export, Veterinary Services, APHIS, inspector may require the holding and (d) Special ports. Charlotte Amalie, 4700 River Road Unit 39, Riverdale, MD 20737– unloading of the means of conveyance St. Thomas, and Christiansted, St. Croix, 1231. and the emptying of the container if he in the United States Virgin Islands, are Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17049 hereby designated as quarantine stations to be imported; the purpose of the importer’s agent must pay the for the entry of ruminants from the importation; individual ruminant reservation fee by check or U.S. money British Virgin Islands into the United identification that includes a order or ensure payment of the States Virgin Islands for immediate description of the ruminant, name, age, reservation fee by an irrevocable letter slaughter. markings, if any, registration number, if of credit from a commercial bank (the (e) Limited ports. The following ports any, and tattoo or eartag; the region of effective date on such letter of credit are designated as having inspection origin; the name and address of the must run to 30 days after the date the facilities for the entry of ruminants and exporter; the port of embarkation in the ruminants are scheduled to be released ruminant test specimens that do not foreign country; the mode of from quarantine); except that anyone appear to require restraint and holding transportation, route of travel, and the who issues a check to the Department inspection facilities: Anchorage and port of entry in the United States; the for a reservation fee that is returned Fairbanks, Alaska; San Diego, proposed date of arrival of the because of insufficient funds shall be California; Jacksonville, St. Petersburg- ruminants or ruminant test specimens to denied any further request for Clearwater, and Tampa, Florida; be imported; and the name of the person reservation of a quarantine space until Atlanta, Georgia; Chicago, Illinois; New to whom the ruminants or ruminant test the outstanding amount is paid. Orleans, Louisiana; Portland, Maine; specimens will be delivered and the (iii) Any reservation fee paid by check Baltimore, Maryland; Boston, location of the place in the United or U.S. money order shall be applied Massachusetts; Minneapolis, Minnesota; States to which delivery will be made against the expenses incurred for Great Falls, Montana; Portland, Oregon; from the port of entry. Additional services received by the importer or San Juan, Puerto Rico; El Paso, information may be required in the form importer’s agent in connection with the Galveston and Houston, Texas; and of certificates concerning specific quarantine for which the reservation Seattle, Spokane, and Tacoma, diseases to which the ruminants are was made. Any part of the reservation Washington. susceptible, as well as vaccinations or fee that remains unused after being (f) Designation of other ports. The other precautionary treatments to which applied against the expenses incurred Secretary of the Treasury has approved the ruminants or ruminant test for services received by the importer or the designation as quarantine stations of specimens have been subjected. Notice the importer’s agent in connection with the ports specified in this section. In of any such requirement will be given the quarantine for which the reservation special cases other ports may be to the applicant in each case.5 was made, shall be returned to the designated as quarantine stations under (2) An application for permit to individual who paid the reservation fee. this section by the Administrator, with import ruminants and/or ruminant test If the reservation fee is ensured by a the concurrence of the Secretary of the specimens may also be denied because letter of credit, the Department will Treasury. of: Communicable disease conditions in draw against the letter of credit unless (g) Ports and privately operated the region of origin, or in a region where payment for services received by the quarantine facilities for sheep. Sheep the shipment has been or will be held importer or importer’s agent in may be entered into the United States at or through which the shipment has been connection with the quarantine is any port specified in paragraph (a) of or will be transported; deficiencies in otherwise made at least 3 days prior to this section, or at any other port the regulatory programs for the control the expiration date of the letter of credit. designated as an international port or or eradication of animal diseases and (iv) Any reservation fee shall be airport by the U.S. Customs Service and the unavailability of veterinary services forfeited if the importer or the quarantined at privately operated in the above mentioned regions; the importer’s agent fails to present for quarantine facilities provided the importer’s failure to provide satisfactory entry, within 24 hours following the applicable provisions of §§ 93.401, evidence concerning the origin, history, designated time of arrival, the lot of 93.404(a), 93.405, 93.406, and 93.407 and health status of the ruminants; the ruminants for which the reservation was are met. lack of satisfactory information made: Except that a reservation fee shall necessary to determine that the not be forfeited if: § 93.404 Import permits for ruminants and importation will not be likely to (A) Written notice of cancellation for ruminant specimens for diagnostic transmit any communicable disease to from the importer or the importer’s purposes; and reservation fees for space at livestock or poultry of the United States; agent is received by the office of the quarantine facilities maintained by APHIS. or any other circumstances that the veterinarian in charge of the quarantine (a) Application for import permit; Administrator believes require such facility 6 during regular business hours reservation required. (1) To import denial to prevent the dissemination of (8:00 a.m. to 4:30 p.m. Monday through ruminants and ruminant test specimens any communicable disease of livestock Friday, excluding holidays) no later for diagnostic screening purposes from or poultry into the United States. than 15 days prior to the beginning of any part of the world, the importer must (3)(i) The importer or importer’s agent the time of importation of the ruminants first apply for and obtain from APHIS an must pay or ensure payment of a as specified in the import permit or as import permit, except that, the reservation fee for each lot of ruminants arranged with the veterinarian in charge following types of ruminants are exempt to be quarantined in a facility of the quarantine facility if no import from import permit requirements when maintained by USDA. For ruminants, permit is required (the 15 days period they are imported through a land border the reservation fee shall be 100 percent shall not include Saturdays, Sundays, or port: sheep and goats from regions of the cost of providing care, feed, and holidays); or classified as Risk Class RN for foot-and- handling during quarantine, as (B) The Administrator determines that mouth disease and rinderpest, when estimated by the quarantine facility’s services, other than provided by imported for immediate slaughter; and veterinarian in charge. carriers, necessary for the importation of cattle, bison, and wethers whether or (ii) At the time the importer or the not they are imported for immediate importer’s agent requests a reservation 6 The addresses of USDA quarantine facilities slaughter. The application must specify may be found in telephone directories listing the of quarantine space, the importer or facilities or by contacting the National Center for the name and address of the importer; Import and Export, Veterinary Services, APHIS, the species, breed, number or quantity 5 See §§ 93.405, 93.406, and 93.415 for additional 4700 River Road Unit 39, Riverdale, MD 20737– of ruminants or ruminant test specimens requirements for the importation of ruminants. 1231. 17050 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules the ruminants within the requested specimens imported are different from date applied must be recorded on the period are unavailable because of those described in the permit; if the health certificate; and unforeseen circumstances as determined ruminants or ruminant test specimens (7) The ruminants were transported to by the Administrator (such as the are not handled as outlined in the the United States only in means of closing of an airport due to inclement application for the import permit and as conveyance or vehicles that were weather or the unavailability of the specified in the permit issued; or if cleaned and disinfected prior to use. reserved space due to the extension of ruminants or swine other than those (b) Prior to entry into the United another quarantine). covered by the import permits are States, the ruminants must be identified (v) If the reservation fee was ensured aboard the transporting carrier. in accordance with § 71.18 of this by a letter of credit and the fee is to be chapter. forfeited under paragraph (a)(3)(iv) of § 93.405 Certificate of export and other (c) Cattle, sheep, and goats that are this section, the Department will draw requirements for ruminants. from a region classified as RN for all against the letter of credit unless the (a) All ruminants imported or offered restricted diseases affecting the type of reservation fee is otherwise paid at least for importation from any part of the animal in question, and that are to be 3 days prior to the expiration date of the world, except for ruminants that are transported in-bond through the United letter of credit. imported for immediate slaughter from States for immediate export, shall be (vi) When a reservation is canceled in regions classified as Risk Class RN for inspected at the border port of entry accordance with paragraph (a)(3)(iv)(A) all restricted agents of ruminants, and and, when accompanied by an import of this section and the provisions of except as provided in paragraphs (c) and permit obtained under § 93.404 and paragraph (a)(3)(iv)(B) of this section do (d) of this section,7 must be when all conditions therein are not apply, a $40.00 cancellation fee accompanied by a certificate of export observed, shall be allowed entry into the shall be charged. If a reservation fee was issued and signed by an authorized United States and shall be otherwise paid, the cancellation fee shall be veterinarian and endorsed by an official handled in accordance with § 93.401(b). deducted from any reservation fee of the National Veterinary Services of (d) Ruminants originating in the returned to the importer or the the country of export, who certifies that United States and transported directly importer’s agent. If the reservation fee the veterinarian signing and issuing the through a region classified as RN for all was ensured by a letter of credit, the certificate is authorized to do so and restricted diseases for the type of Department will draw the amount of the who certifies that: ruminant being transported, may re- cancellation fee against the letter of (1) The ruminants originate from enter the United States without foreign credit unless the cancellation fee is premises that are not known to have health or test certificates when otherwise paid at least 3 days prior to been affected with any communicable accompanied by copies of the United the expiration date of the letter of credit. diseases of ruminants during the States export health certificates properly (b) Import Permit. When an import previous 60 days; issued and endorsed in accordance with permit is issued, the original and two (2) The ruminants originate from the regulations in part 91 of this copies will be sent to the importer. It premises that are not known to have chapter: Provided, That, to qualify for shall be the responsibility of the been affected with restricted reentry into the United States, the date, importer to forward the original import ectoparasites of ruminants during the time, port of entry, and signature of the permit and one copy to the shipper in previous 60 days; port veterinarian of the foreign country the country of origin, and it shall also (3) During transportation to the port of that inspected the ruminants for entry be the responsibility of the importer to embarkation there was no direct or into the foreign country shall be insure that the shipper presents the indirect exposure to any potential recorded on the United States health copy of the import permit to the carrier carrier animals from any region affected certificate, or a paper containing such and makes proper arrangements for the with restricted agents that affect information shall be attached to the original permit to accompany the ruminants; certificate that accompanies the shipment to the specified U.S. port of (4) While en route to the port of entry, ruminants. In all cases, it shall be entry for presentation to the collector of the ruminants were not trailed or driven determined by the veterinary inspector customs. All ruminants and ruminant through any Risk Class R3, R4 or RU at the United States port of entry that test specimens for diagnostic screening region for any tick-borne restricted the ruminants are the identical purposes intended for importation into agents that affect ruminants; ruminants covered by said certificate. the United States for which an import (5) While en route to the port of entry, (e) If any ruminants are permit has been issued, must be the ruminants were not trailed, driven, unaccompanied by the export certificate received at the specified port of entry transported, or otherwise moved as required by paragraph (a) of this within the time prescribed in the import through any Risk Class R3, R4, or RU section, or if such ruminants are found permit and shall not exceed 14 days region for any restricted insect- upon inspection at the United States from the first day that the permit is transmitted agents that affect ruminants, port of entry to be affected with or to effective for all permits relevant to the during a time of year when insect have been exposed to a communicable shipment or shipments. All ruminants vectors were active; disease, they shall be refused entry and and ruminant test specimens for which (6) The ruminants were either shall be handled thereafter in an import permit is required by these inspected on the day of embarkation accordance with the provisions of regulations will not be eligible for entry and were found to be free of restricted section 8 of the Act of August 30, 1890 into the United States if an import ectoparasites as listed in § 92.2 of this (26 Stat. 416; 21 U.S.C. 103), or permit has not been issued; if the chapter, or were treated with one of the quarantined, or otherwise disposed of as ruminants or ruminant test specimens permitted treatments listed in § 72.13(b) the Administrator may direct. are unaccompanied by such a permit; if of this chapter within 10 to 14 days of the shipment is from any port other than embarkation. If treated, the pesticide, § 93.406 Permit, certificate, declaration the one designated in the permit; if active ingredient, concentration, and and other documents for ruminants. arrival in the United States is at any port (a) The export certificates, import other than the one designated in the 7 See § 93.415 for additional requirements for permits, declarations, and affidavits permit; if the ruminants or ruminant test ruminants imported from specific risk class regions. required by the regulations in this part Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17051 must be presented by the importer or his said ruminants may not be moved over When it is found necessary to extend or her agent to the collector of customs any highways nor allowed to come in the usual minimum quarantine period, at the port of entry upon arrival of contact with other animals, but must be the importer, or his or her agent, shall ruminants at such port, for the use of transferred from the conveyance to the be so advised in writing and must pay the veterinary inspector at the port of quarantine grounds only in boats, cars, for such additional quarantine and other entry. or vehicles approved by the inspector in services required. Payment for all (b) For all ruminants imported or charge at the port of entry. Such cars, services received by the importer, or his offered for importation, the importer or boats, or vehicles must be cleaned and or her agent, in connection with each his or her agent must first present two disinfected under APHIS supervision separate lot of ruminants must be made copies of a declaration that lists the port immediately after such use, by the by certified check or U.S. money order of entry, the name and address of the carrier moving the same. The railway prior to release of the ruminants. If such importer, the name and address of the cars so used must be either cars reserved payment is not made, the ruminants broker, the origin of the ruminants, the for this exclusive use or box cars not may be sold in accordance with the number, breed, species, and purpose of otherwise employed in the procedure described in paragraph (b) of the importation, the name of the person transportation of animals or their fresh this section, or otherwise disposed of as to whom the ruminants will be products. When movement of the directed by the Administrator. delivered, and the location of the place aforesaid ruminants upon or across a (b) Quarantine facilities maintained to which such delivery will be made. public highway is unavoidable, it shall by APHIS. The importer, or his or her be under such careful supervision and § 93.407 Inspection at the port of entry. agent, of ruminants subject to restrictions as the inspector in charge at quarantine under the regulations in this Ruminants imported from any part of the port of entry and the local subpart must arrange for acceptable the world must be inspected at the authorities may direct. transportation to the quarantine facility, United States port of entry. All § 93.410 Ruminant quarantine facilities. and for the care, feed, and handling of ruminants found to be free from the ruminants from the time they arrive communicable disease and not to have (a) Privately operated quarantine facilities. The importer, or his or her at the quarantine port to the time of been exposed thereto within 60 days release from quarantine. Such prior to their exportation to the United agent, of ruminants subject to quarantine under the regulations in this arrangements shall be agreed to in States shall be admitted subject to the advance by the Administrator. The other provisions in this part; all other subpart must arrange for acceptable transportation to the privately operated importer or his or her agent shall ruminants shall be refused entry. request in writing such inspection and Ruminants refused entry, unless quarantine facility and for the care, feed, and handling of the ruminants from the other services as may be required, and exported within a time fixed in each shall waive all claim against the United case by the Administrator, and in time of unloading at the quarantine port to the time of release from quarantine. States and APHIS or any employee of accordance with other provisions he or APHIS, for damages that may arise from she may require in each case for their Such arrangements shall be agreed to in advance by the Administrator. All such services. All expenses resulting handling, shall be disposed of as the therefrom or incident thereto shall be Administrator may direct, in accordance expenses resulting therefrom or incident thereto shall be the responsibility of the the responsibility of the importer; with provisions of section 2 of the Act APHIS assumes no responsibility with of July 2, 1962 (21 U.S.C. 134a), or the importer; APHIS assumes no responsibility with respect thereto. The respect thereto. The Administrator may provisions of section 8 of the Act of quarantine facility must be suitable for prescribe reasonable rates for the August 30, 1890 (21 U.S.C. 103). Such the quarantine of such ruminants and services provided under this paragraph. portions of the transporting vessel, and must be approved by the Administrator When it is found necessary to extend of its cargo, that have been exposed to prior to the issuance of any import the usual minimum quarantine period, any such ruminants or their emanations, permit. The facilities occupied by the importer, or his or her agent, shall must be disinfected in such manner as ruminants must be kept clean and be so advised in writing and must pay may be considered necessary by the sanitary. If for any cause the care, feed, for such additional quarantine and other inspector in charge at the port of entry or handling of ruminants, or the services required. Payment for services to prevent the introduction or spread of sanitation of the facilities, is neglected, received by the importer, or his or her livestock or poultry disease, before the in the opinion of the inspector assigned agent, in connection with each separate cargo is allowed to land. to supervise the quarantine, such lot of ruminants must be made by § 93.408 Articles accompanying services may be furnished by APHIS in certified check or U.S. money order ruminants. the same manner as though prior to release of the ruminants. If such No litter or manure, fodder or other arrangements had been made for such payment is not made, the ruminants aliment, nor any equipment such as services as provided by paragraph (b) of may be sold in accordance with the boxes, buckets, ropes, chains, blankets, this section, and/or the ruminants may procedure described in this paragraph or other things used for or about be disposed of as the Administrator may or otherwise disposed of as directed by ruminants governed by the regulations direct, including sale in accordance the Administrator. When payment is not in this subpart, may be landed from any with the procedure described in made and the ruminants are to be sold conveyance except under such paragraph (b) of this section. The to recover payment for services restrictions as the inspector in charge at importer, or his or her agent, must received, the importer, or his or her the port of entry shall direct. request in writing such inspection and agent, will be notified by the inspector other services as may be required, and that if said charges are not immediately § 93.409 Movement from conveyances to shall waive all claim against the United paid or satisfactory arrangements made quarantine station. States and APHIS or any employee of for payment, the ruminants will be sold Platforms and chutes used for APHIS for damages that may arise from at public sale to pay the expense of care, handling imported ruminants must be such services. The Administrator may feed, and handling during that period. cleaned and disinfected under APHIS prescribe reasonable rates for the The sale will be held after the expiration supervision after being so used. The services provided under this paragraph. of the quarantine period, at such time 17052 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules and place as may be designated by the special precautions shall be taken to be imported were born and resided only General Services Administration of the prevent spread of the infection to other in regions that are classified as Risk United States Government or other animals in the quarantine station or to Class RN or R1 for M. bovis. designated selling agent. The proceeds those outside the grounds. The affected (2) Regions classified as Risk Class R2 of the sale, after deducting the charges ruminants in post-importation for M. bovis. for care, feed, and handling of the quarantine shall be disposed of as the (i) In addition to the export ruminants and other expenses, Administrator may direct, depending requirements of § 93.405, the certificate including the expense of the sale, shall upon the nature of the disease. of export for live ruminants over 6 be held in a Special Deposit Account in (b) If there are test-positive animals months of age from regions that are the United States Treasury for 6 months during the post-importation quarantine classified as Risk Class R2 for M. bovis, from the date of sale. If not claimed by (in the absence of clinical signs of must certify that: the importer, or his or her agent, within disease), the Administrator may require (A) The ruminants to be imported 6 months from the date of sale, the additional testing of the test-positive were born and resided only in regions amount so held shall be transferred from animal(s) and/or test-negative animals that are classified as Risk Class RN, R1, the Special Deposit Account to the to determine if any of the animals will or R2 for M. bovis; and General Fund Account in the United be eligible for entry into the United (B) If the ruminants to be imported are States Treasury. States. not neutered, that the ruminants have § 93.411 Quarantine stations, visiting § 93.415 Requirements for importation of had a negative result to an approved test restricted; sales prohibited. live ruminants from various risk class for M. bovis not less than 60 nor more Visitors shall not be admitted to the regions. than 90 days (not less than 90 nor more quarantine enclosure during any time Ruminants may be imported from any than 120 days for any non-neutered that ruminants are in quarantine except regions of the world only if they meet cervidae) prior to export. that an importer (or his or her the requirements of this section, and all (ii) Non-neutered ruminants must be accredited agent or veterinarian) may be other applicable requirements of this detained at the port of entry or admitted to the yards and buildings part.8 designated entry quarantine facility for containing his or her quarantined (a) Regions classified as Risk Class RN a minimum of 72 hours until tested with ruminants at such intervals as may be for all restricted agents affecting negative results to an approved test for deemed necessary, and under such ruminants. In addition to the export M. bovis. reasonable conditions and restrictions certificate requirements of § 93.405, the (3) Regions classified as Risk Class R3 as may be imposed, by the inspector in certificate of export for live ruminants for M. bovis. (i) In addition to the export charge of the quarantine station. On the from regions that are classified as Risk certificate requirements of § 93.405, the last day of the quarantine period, Class RN must certify that the ruminants certificate of export for live ruminants owners, officers or registry societies, to be imported have only been on over 6 months of age from regions that and others having official business or premises located in regions listed as are classified as R3 for M. bovis must whose services may be necessary in the Risk Class RN for the specific restricted certify that: removal of the ruminants may be agent and that they meet all other (A) The ruminants to be imported admitted upon written permission from requirements of this subpart. were born and resided only in regions the said inspector. No exhibition or sale (b) Mycobacterium bovis. Any classified as Risk Class RN, R1, R2, or shall be allowed within the quarantine ruminant with positive results to an R3 for M. bovis; grounds. approved test for M. bovis shall be (B) The ruminants to be imported refused entry. Ruminants with negative have had a negative result to an § 93.412 Milk from quarantined ruminants. results may be eligible for entry based approved test for M. bovis not less than Milk or cream from ruminants on their status as determined by part 77 60 nor more than 90 (not less than 90 quarantined under the provisions of this of this chapter. However, all ruminants nor more than 120 days for cervidae) subpart may not be used by any person imported for immediate slaughter are days prior to export; and other than those in charge of such exempt from M. bovis testing and (C) If the ruminants to be imported are ruminants, nor be fed to any animals quarantine requirements. Such non-neutered ruminants from herds of other than those within the same ruminants must be consigned from the origin that do not meet the requirements enclosure, without permission of the port of entry to a recognized for accredited free herd status in part 77 inspector in charge of the quarantine slaughtering establishment and there of this chapter, the ruminants come station and subject to such restrictions slaughtered within 2 weeks from the from herds that have had a negative as he or she may consider necessary to date of import. Such ruminants must be result to an approved test for M. bovis each instance. No milk or cream may be moved from the port of entry in no less than 4 months nor more than 12 removed from the quarantine premises conveyances closed with official seals of months prior to the date of export. except in compliance with all State and the United States Government applied (ii) Neutered ruminants must be local regulations. and removed by an APHIS identified by a permanent, legible mark § 93.413 Manure from quarantined representative, or an individual on the right hip. The mark must consist ruminants. authorized for this purpose by an APHIS of an ‘‘M’’ for neutered males and an representative. ‘‘Mx’’ for neutered females, not less than No manure may be removed from the ′′ ′′ quarantine premises until the release of (1) Regions classified as Risk Class R1 2 nor more than 3 high. the ruminants producing the manure. for M. bovis. In addition to the export (iii) Non-neutered ruminants must be certificate requirements of § 93.405, the detained at the United States port of § 93.414 Appearance of disease among certificate of export for live ruminants entry or designated entry quarantine ruminants in quarantine. over 6 months of age from regions that facility a minimum of 72 hours until (a) If any restricted agent or other are classified as Risk Class R1 for M. tested with negative results to an communicable disease appears among bovis, must certify that the ruminants to approved test for M. bovis. ruminants during the pre-embarkation (4) Regions classified as R4 and RU or post-importation quarantine periods, 8 8 See §§ 93.404, 93.405, and 93.406. for M. bovis. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17053

(i) In addition to the export certificate regions classified as Risk Class R3 for B. (C) Have undergone a minimum of 30 requirements of § 93.405, the certificate abortus, B. suis biovar 4, and B. days pre-embarkation quarantine prior of export for live ruminants over 6 melitensis. to export; and months of age from regions that are (i) To be considered as from a (D) Have had a negative result to an classified as Risk Class R4 or RU for M. brucellosis certified-free herd, an approved test for B. abortus, B. suis bovis must certify that the ruminants to animal’s herd must be the requirements biovar 4, and B. melitensis within the 30 be imported: for a brucellosis certified-free herd in days prior to export. (A) Have had a negative result to an part 78 of this chapter. (ii) The ruminants must be approved test for M. bovis not less than (ii) In addition to the export certificate quarantined for at least 15 days at a 30 nor more than 60 days (60–90 days requirements of § 93.405, the certificate post-importation quarantine designated for cervidae) prior to export; of export for live non-neutered and approved by the Administrator. (B) Originate from herds in which the ruminants over 6 months of age from (iii) The ruminants must have a entire herd has had a negative result to regions that are classified as Risk Class negative result to approved tests for B. an approved test for M. bovis not less R2 or (if the ruminants are from abortus, B. suis biovar 4, and B. than 4 nor more than 12 months prior brucellosis certified-free herds) as Risk melitensis during the post-importation to the date of exportation; and Class R3 for B. abortus, B. suis biovar 4, quarantine period. (C) Non-neutered ruminants have and B. melitensis must certify that the (d) Foot-and-mouth disease (FMD) undergone at least 60 days (90 days for ruminants to be imported: virus. All ruminants imported for cervidae) of pre-embarkation quarantine (A) Were born and resided only in immediate slaughter that are born and prior to export. regions that are classified as Risk Class raised in regions classified as Risk Class (ii) Neutered ruminants must be RN, R1, or R2, or regions that are R1 or R2 for FMD are exempt from the identified by a permanent, legible mark classified as Risk Class R3 (if brucellosis test and quarantine requirements of this on the right hip. The mark must consist certified-free herds) for B. abortus, B. section. The ruminants must be of an ‘‘M’’ for neutered males and an suis biovar 4, and B. melitensis; consigned from the port of entry to a ‘‘Mx’’ for neutered females, not less than recognized slaughtering establishment ′′ ′′ (B) If vaccinated, have only been 2 nor more than 3 high. vaccinated with B. abortus Strain 19 and there slaughtered within 48 hours (iii) Non-neutered ruminants to be according to the procedures in part 78 from the date of entry. The ruminants imported must be quarantined at a post- of this chapter; and must be moved from the port of entry importation quarantine facility (C) Had a negative result to an in conveyances closed with official seals designated and approved by the approved test for brucellosis no less of the United States Government Administrator for a minimum of 30 than 30 nor more than 60 days prior to applied and removed by an APHIS days, during which time they must be the date of exportation. representative, or an individual tested with negative results with an (iii) The ruminants must be detained authorized for this purpose by an APHIS approved test for M. bovis. at the port of entry or quarantine facility representative. (c) Brucella abortus, B. suis biovar 4, (1) Regions classified as Risk Class R1 until tested with negative results for B. and B. melitensis. All ruminants for FMD virus. In addition to the export abortus, B. suis biovar 4, and B. imported for immediate slaughter are certificate requirements of § 93.405, the melitensis under the supervision of the exempt from all brucellosis test and certificate of export for live ruminants port veterinarian. quarantine requirements. Such from regions that are classified as Risk (3) Regions classified as Risk Class R3 ruminants must be consigned from the Class R1 for FMD must certify that the (if the ruminants are not from herds port of entry to a recognized ruminants to be imported: certified free of brucellosis), R4, and RU slaughtering establishment and there be (i) Were born and resided only in for B. abortus, B. suis biovar 4, and B. slaughtered within 2 weeks from the regions listed as Risk Class RN or R1 for melitensis. (i) In addition to the export date of entry. Such ruminants must be FMD; moved from the port of entry in certificate requirements of § 93.405, the (ii) Have not been vaccinated for conveyances closed with official seals of certificate of export for live non- FMD; and the United States Government applied neutered ruminants from regions that (iii) Have had a negative result to an and removed by an APHIS are classified as Risk Class R3 (if the approved serological test for FMD representative, or an individual ruminants are not from herds certified within 30 days prior to the date of authorized for this purpose by an APHIS as free of brucellosis), R4, and RU for B. export. representative. abortus, B. suis biovar 4, and B. (2) Regions classified as Risk Class R2 (1) Regions classified as Risk Class R1 melitensis must certify that the for FMD virus. (i) In addition to the for B. abortus, B. suis biovar 4, and B. ruminants to be imported: export certificate requirements of melitensis. In addition to the export (A) Originated from a herd where all § 93.405, the certificate of export for live certificate requirements of § 93.405, the non-neutered ruminants over 6 months ruminants from regions that are certificate of export for live non- of age had negative results to an classified as Risk Class R2 for FMD neutered ruminants over 6 months of approved brucellosis test not more than virus must certify that the ruminants to age from regions that are classified as 12 months nor less than 6 months prior be imported: Risk Class R1 for B. abortus, B. suis to export; If any test-positive animals (A) Were born and resided only in biovar 4, and B. melitensis must certify were found during the herd test, they regions classified as Risk Class RN, R1 that the ruminants to be imported: were removed from the herd and all or R2 for FMD; (i) Were born and resided only in remaining animals were re-tested with (B) Have not been vaccinated for regions that are classified as Risk Class negative results not less than 6 months FMD; RN or R1 for B. abortus, B. suis biovar after any test positive animals were (C) Have had a negative result to an 4, and B. melitensis; and removed; approved serological test for FMD (ii) Have not been vaccinated with (B) If vaccinated, have been within 30 days prior to export; and any live brucella vaccine. vaccinated only with B. abortus Strain (D) Underwent pre-embarkation (2) Regions classified as Risk Class R2 19 according to the procedures in part quarantine for a minimum of 30 days or (if brucellosis certified-free herds) 78 of this chapter; prior to export. 17054 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

(ii) The ruminants must undergo post- (D) Have undergone pre-embarkation (ii) Approval of a zoological park for importation quarantine for a minimum quarantine for at least 60 days prior to the receipt and maintenance of of 15 days at a facility designated and export under USDA supervision in a imported wild ruminants as described approved by the Administrator. facility approved by the Administrator in this paragraph, shall be on the basis (iii) The ruminants must have a according to § 93.431; and of an inspection, by an authorized negative result to an approved (E) During pre-embarkation representative of the Department, of the serological test for FMD during the post- quarantine, have had negative results to physical facilities of the establishment importation quarantine period. two tests conducted not less than 15 and its methods of operation. Standards (3) Regions classified as Risk Class R3 days apart for FMD virus using an for acceptable physical facilities shall for FMD virus. approved serological test. If indicated, include satisfactory pens, cages, or (i) In addition to the export certificate oesophageal-pharyngeal fluid samples enclosures in which the ruminants can requirements of § 93.405, the certificate were taken for further testing. be maintained so as not to be in contact of export for live ruminants from (ii) The ruminants to be imported with the general public and free from regions that are classified as Risk Class must be quarantined at the Harry S contact with domestic livestock; natural R3 for FMD virus, must certify that the Truman Animal Import Center or established drainage from the ruminants to be imported: according to the procedures of § 93.430 zoological park that will avoid (A) Were born and resided only in for at least 90 days with sentinel contamination of land areas where regions listed as Risk Class RN, R1, R2 animals, during which time such domestic livestock are kept or with or R3 for FMD; animals will be subjected to a test for which domestic livestock may (B) Have not been vaccinated for FMD virus at least once using an otherwise come in contact; provision for FMD; approved serological test. If indicated, the disposition of manure, other wastes, (C) Have not been on any premises oesophageal-pharyngeal fluid samples and dead ruminants within the affected with FMD virus during the 12 will be taken for further testing. zoological park; and other reasonable months prior to export; facilities considered necessary to (D) Have not been on any premises (5) Wild ruminants from R3, R4, or RU regions affected with foot-and-mouth prevent the dissemination of diseases located within 25 miles (40 km) of any from the zoological park. The operator premises affected with FMD virus in the disease or rinderpest. (i) Wild ruminants originating in regions classified as Risk of the zoological park must have 90 days prior to export; available the services of a full-time or (E) Have undergone pre-embarkation Class R3, R4 or RU for foot-and mouth disease or rinderpest may be carriers of part-time veterinarian, or a veterinarian quarantine for at least 60 days prior to on a retainer basis, who must make export under USDA supervision in a such diseases even though the animals do not show clinical evidence of the periodic examinations of all animals facility approved by the Administrator maintained at the zoological park for according to § 93.431 of this subpart; diseases. In view of these circumstances and in order to prevent the introduction evidence of disease; who must make a and post-mortem examination of each (F) Have had, during the pre- and dissemination of restricted agents of animal that dies; and who must make a embarkation quarantine, negative results livestock and to protect the livestock of prompt report of suspected cases of to two tests not less than 15 days apart the United States, import permits for the contagious or communicable diseases to for FMD virus using an approved importation of wild ruminants, such as, appropriate State or Federal livestock serological test. If indicated, but not limited to, giraffes, deer and sanitary officials. oesophageal-pharyngeal fluid samples antelopes, will be issued only if such will be taken for further testing. animals are intended for exhibition (iii) Manure and other animal wastes (ii) The ruminants to be imported purposes in a zoological park previously must be disposed of within the must be quarantined at the Harry S approved by the Administrator, in zoological park for a minimum of 1 year Truman Animal Import Center accordance with the standards specified following the date a ruminant enters the according to the procedures of § 93.430 in paragraph (d)(5)(ii) of this section and park. If an APHIS veterinarian for at least 60 days without sentinel if the operator of such approved determines that a ruminant shows no animals, during which time such zoological park and the importer, if such signs of any illness at the end of this 1- animals will be subjected to a test for operator and importer are different year period, its manure and other wastes FMD virus at least once using an parties, has or have entered into the need not be disposed of within the park. approved serological test. If indicated, agreement set forth in paragraph If, however, an APHIS veterinarian oesophageal-pharyngeal fluid samples (d)(5)(iv) of this section with APHIS for determines that a ruminant does show will be taken for further testing. the maintenance and handling of such signs of any illness at the end of this 1- (4) Regions classified as Risk Class R4 wild ruminants in the manner specified year period, an APHIS veterinarian will or RU for FMD virus. in the agreement to prevent the investigate the illness and determine (i) In addition to the export certificate introduction and dissemination of whether the ruminant’s manure and requirements of § 93.405, the certificate communicable disease. The New York other wastes may safely be disposed of of export for live ruminants from port of entry is the only port at which outside the zoological park. regions that are classified as Risk Class facilities are available that are adequate (iv) Prior to the issuance of an import R4 or RU for FMD must certify that the for the quarantining of wild ruminants. permit under this section and § 93.404, ruminants to be imported: Accordingly, permits issued for the the operator of the approved zoological (A) Have not been vaccinated for importation of such wild ruminants will park to which the wild ruminants are to FMD; require that the ruminants be imported be consigned, and the importer of the (B) Have not been on any premises through the port of New York and be wild ruminants, if such operator and affected with FMD virus during the 12 quarantined at that port. The importer are different parties, must months prior to export; Administrator may cancel such a permit execute an agreement covering each (C) Have not been on a premises when he or she finds that any provision wild ruminant or group of wild located within 25 miles (40 km) of any of this section or any other provision of ruminants for which the import permit premises affected with FMD virus in the the regulations has not been or is not is requested. The agreement shall be in 90 days prior to export; being complied with. the following form: Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17055

Agreement for the Importation, Quarantine lllllllllllllllllllll (3) Regions classified as Risk Class R3 and Exhibition of Certain Wild Ruminants (Title of officer) for rinderpest and PPR. and Wild Swine Subscribed and sworn to before me this ll lllll (i) In addition to the export certificate , operator(s) of the zoological day of lllll, 19ll. lllll requirements of § 93.405, the certificate park known as (Name) located at lllllllllllllllllllll lllll lllll of export for live ruminants from (City and state), and (Title or designation) (Importer) hereby request a permit for the regions that are classified as Risk Class importation of lllll (Number and (e) Rinderpest and peste de petits R3 for rinderpest and/or PPR must kinds of animals) for exhibition purposes at ruminants (PPR). Ruminants imported certify that the ruminants to be the said zoological park, said animals for immediate slaughter that are born imported: originating in a Risk Class R3, R4, or RU and raised in regions classified as Risk (A) Were born and resided only in region for foot-and-mouth disease or Class R1 or R2 for rinderpest and/or PPR regions listed as Risk Class RN, R1, R2 rinderpest, and being subject to restrictions are exempt from the test and quarantine or R3 for rinderpest and/or PPR; under regulations contained in part 93, title requirements of this section. Such (B) Have not been vaccinated for 9, Code of Federal Regulations. ruminants must be consigned from the rinderpest or PPR; In making this request, it is understood and port of entry to a recognized (C) Have not been on any premises agreed that: slaughtering establishment and there affected with rinderpest and/or PPR 1. The animals for which an import permit virus during the 12 months prior to is requested will be held in isolation at a port slaughtered within 2 weeks from the date of entry, and be moved from the export; of embarkation in the country of origin, (D) Have not been on a premises approved by the Administrator as a port port of entry in conveyances closed with official seals of the United States located within 25 miles (40 km) of any having facilities that are adequate for premises affected with rinderpest and/ maintaining wild animals in isolation from Government applied and removed by an or PPR virus in the 90 days prior to all other animals and having veterinary APHIS representative, or an individual supervision by officials of the country of authorized for this purpose by an APHIS export; origin of the animals. Such animals will be representative. (E) Have undergone pre-embarkation held in such isolation for not less than 60 (1) Regions classified as Risk Class R1 quarantine for a minimum of 30 days days under the supervision of the veterinary for rinderpest and PPR. In addition to prior to export under USDA supervision service of that country to determine whether the export certificate requirements of in a facility approved by the the animals show any clinical evidence of § 93.405, the certificate of export for live Administrator in accordance with restricted agents or other communicable ruminants from regions that are § 93.431; disease and to assure that the animals will classified as Risk Class R1 for rinderpest (F) During pre-embarkation not have been exposed to such a disease quarantine, have had negative results to within the 60 days prior to their exportation and/or PPR must certify that the ruminants to be imported: two tests conducted not less than 15 from that country. days apart for rinderpest and/or PPR 2. Shipment will be made directly from (i) Were born and resided only in regions classified as Risk Class RN or R1 virus using an approved serological test. such port of embarkation to the port of New If indicated, nasal swabs or other tissues York as the port of entry into the United for rinderpest and/or PPR; States. If shipment is made by ocean vessel (ii) Have not been vaccinated for or samples will be taken for further the animals will not be unloaded in any rinderpest or PPR; and testing. foreign port en route. If shipment is made by (iii) Have had a negative result to an (ii) The ruminants to be imported air, the animals will not be unloaded at any approved serological test for rinderpest must be quarantined at the Harry S port or other place of landing except at a port and/or PPR within 30 days prior to Truman Animal Import Center approved by the Administrator as a port not export. according to the procedures of § 93.430 located in a region classified as R3, R4, or RU (2) Regions classified as Risk Class R2 for at least 30 days without sentinel for rinderpest or foot-and-mouth disease or as for rinderpest and PPR. (i) In addition animals, during which time the animals a port in such a region having facilities and to the export certificate requirements of will be subjected to a test for rinderpest inspection approved by the Administrator as § 93.405, the certificate of export for live and/or PPR virus at least once using an adequate for maintaining wild animals in ruminants from regions that are approved serological test. If indicated, isolation from all other animals. nasal swabs or other samples will be 3. No ruminants or swine will be aboard classified as Risk Class R1 for the transporting vehicle, vessel or aircraft Rinderpest and/or PPR must certify that taken for further testing. except those for which an import permit has the ruminants offered to be imported: (4) Regions classified as Risk Class R4 been issued. (A) Were born and resided only in or RU for rinderpest and PPR. 4. The animals will be quarantined for not regions listed as Risk Class RN, R1 or R2 (i) In addition to the export certificate less than 30 days in the Department’s Animal for rinderpest and/or PPR; requirements of § 93.405, the certificate Import Center in Newburgh, New York. (B) Have not been vaccinated for of export for live ruminants from 5. Upon release from quarantine, the rinderpest or PPR; regions that are classified as Risk Class animals will be delivered to the zoological (C) Have undergone pre-embarkation R4 or RU for rinderpest and PPR must park named in this agreement to become the quarantine for a minimum of 30 days certify that the ruminants to be property of the park and they will not be prior to export; and imported: sold, exchanged or removed from the (D) Have had a negative result to an (A) Have not been vaccinated for premises without the prior consent of APHIS. approved serological test for rinderpest rinderpest or PPR; lllllllllllllllllllll and/or PPR 30 days prior to export. (B) Have not been on any premises (Signature of importer) (ii) The ruminants must undergo post- affected with rinderpest and PPR virus Subscribed and sworn to before me this importation quarantine for a minimum during the 12 months prior to export; lllll day of lllll, 19ll. of 15 days at a facility designated and (C) Have not been on a premises lllllllllllllllllllll approved by the Administrator. located within 25 miles (40 km) of any (Title or designation) (iii) The ruminants must have a premises affected with rinderpest and lllllllllllllllllllll negative result to an approved PPR virus in the 90 days prior to export; (Name of zoological park) serological test for rinderpest and/or (D) Have undergone pre-embarkation By lllll (Signature of officer of PPR during the post-importation quarantine for a minimum of 30 days zoological park) quarantine period. prior to export under USDA supervision 17056 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules in a facility approved by the ruminants will be refused entry until addition to the export certificate Administrator according to § 93.431; treated with one of the permitted requirements of § 93.405, the certificate and treatments listed in § 72.13(b) of this of export for sheep or goats from regions (E) During pre-embarkation chapter, and retreated 10 to 14 days that are classified as Risk class R1 for quarantine, have had negative results to after the initial treatment. CA, SP, GP, and/or CCPP must certify two tests conducted not less than 15 (g) Bovine Spongiform that the sheep and goats to be imported: days apart for rinderpest and PPR virus Encephalopathy (BSE)—(1) Regions (i) Were born and resided only in using an approved serological test. If classified as Risk Class R1 or R2 for regions classified as Risk Class RN or R1 indicated, nasal swabs or other samples BSE. In addition to the export certificate for CA, SP, GP, or CCPP; will be taken for further testing. requirements of § 93.405, the certificate (ii) Have had a negative result to an (ii) The ruminants to be imported of export for live cattle from regions approved serological test for CA, SP, GP, must be quarantined at the Harry S classified as Risk Class R1 or R2 for BSE and/or CCPP within 30 days prior to Truman Animal Import Center must certify that the cattle offered to be export; and according to the procedures of § 93.430 imported were born and resided only in (iii) Have not been vaccinated for CA, for at least 30 days with sentinel R1 or R2 regions, and that the cattle SP, GP, and/or CCPP. animals, during which time such have only been on premises where no (2) Regions classified as Risk Class R2 animals will be subjected to a test for cases of BSE have been diagnosed for CA, SP, GP, and/or CCPP. Rinderpest and/or PPR virus at least during the 10 years immediately (i) In addition to the export certificate once using an approved serological test. preceding the date of exportation. requirements of § 93.405, the certificate If indicated, nasal swabs or other (2) Regions classified as Risk Class of export for sheep or goats from regions samples will be taken for further testing. R3, R4, RU for BSE. The importation of classified as Risk Class R2 for CA, SP, (f) Restricted ectoparasites—(1) live cattle from regions that are GP, and/or CCPP must certify that the Regions classified as Risk Class R1 or R2 classified as Risk Class R3, R4, or RU for sheep or goats to imported: regions for restricted ectoparasites. (i) In BSE is prohibited. (A) Were born and resided only in addition to the export certificate (h) Scrapie—(1) Regions classified as regions listed as Risk Class RN, R1 or R2 requirements of § 93.405, the certificate Risk Class R1 or R2 for scrapie. In for CA, SP, GP, and CCPP; of export for live ruminants from addition to the export certificate (B) Have had a negative result to an regions that are classified as Risk Class requirements of § 93.405, the certificate approved serological test for CA, SP, GP, R1 or R2 for restricted ectoparasites of export for live sheep or goats from and/or CCPP 30 to 60 days prior to must certify that the ruminants to be regions that are classified as Risk Class export to the United States; and imported resided for the 60 days prior R1 or R2 for scrapie must certify that the (C) Have not been vaccinated for CA, to export only in regions listed as Risk imported sheep or goats have only been SP, GP, or CCPP. Class RN, R1, or R2 for restricted on premises where no cases of scrapie (ii) The sheep or goats to be imported ectoparasites. have been diagnosed during the 5 years must be quarantined for at least 15 days (ii) All ruminants to be imported must immediately preceding the date of at a post-importation quarantine facility be inspected at the port of entry for intended exportation, and have resided designated and approved by the ectoparasites, and given a precautionary only in regions listed as R1 or R2. Administrator. treatment with one of the permitted (2) Regions classified as Risk Class R3 (iii) The sheep or goats must have a treatments listed in § 72.13(b) of this for scrapie. In addition to the negative result to an approved chapter. If found to be infested with requirements of § 93.405, the certificate serological test for CA, SP, GP, and/or restricted ectoparasites, the ruminants of export for live sheep or goats from CCPP during the post-importation will be refused entry until treated with regions that are classified as classified quarantine period. one of the permitted treatments listed in as Risk Class R3 for scrapie must certify (3) Regions listed as Risk Class R3 for § 72.13(b) of this chapter, and retreated that the sheep and goats to be imported: CA, SP, GP, and/or CCPP. (i) In addition 10 to 14 days after the initial treatment. (i) Have been inspected on the to the export certificate requirements of (2) Regions classified as Risk Class premises of origin and found free of § 93.405, the certificate of export for R3, R4, or RU for restricted scrapie; sheep or goats from regions classified as ectoparasites. (i) In addition to the (ii) That, as far as can be determined, Risk class R3 for CA, SP, GP, and/or export certificate requirements of scrapie has not existed on any premises CCPP must certify that the sheep or § 93.405, the certificate of export for live on which such sheep or goats were goats to be imported: ruminants from regions that are located during the 42 months (A) Were born and resided only in classified as Risk Class R3, R4 or RU for immediately prior to shipment to the regions listed as Risk Class RN, R1, R2 restricted ectoparasites must certify that United States; and or R3 for CA, SP, GP, and CCPP; the ruminants to be imported: (iii) That each of the animals is not (B) Have not been vaccinated for CA, (A) Were treated for ectoparasites the progeny of a sire or dam that has SP, GP, or CCPP; with an approved treatment 10 to 14 been affected with scrapie. (C) Meet one of the following days prior to export. If quarantine in a (3) Regions classified as Risk Class R4 requirements: pre-embarkation facility is required or RU for scrapie. The importation of (1) Have had a negative result to an under this subpart, the ruminants were live sheep or goats from regions that are approved serological test for CA, SP, GP, treated immediately prior to entering a classified as R4 or RU for scrapie is and/or CCPP 30 to 60 days prior to pre-embarkation facility; and prohibited. export to the United States; or (B) Were inspected while at the pre- (i) Contagious agalactia (CA) due to (2) Originate from a herd or flock in embarkation facility and found to be Mycoplasma agalactiae, sheep pox virus which all sheep and goats over 6 free of any ectoparasites. (SP), goat pox virus (GP), and months of age have had a negative result (ii) The ruminants to be imported contagious caprine pleuropneumonia to an approved serological test within must be inspected at the port of entry due to Mycoplasma mycoides subsp. 12 months prior to the time of export; for any ectoparasites, and given a capri (CCPP). and precautionary treatment. If found to be (1) Regions classified as Risk Class R1 (D) Were quarantined for at least 30 infested with any ectoparasites, the for CA, SP, GP, and/or CCPP. In days prior to export from all animals not Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17057 part of the group to be imported in (A) Were born and resided only in two tests conducted not less than 15 facilities approved by the regions classified as Risk Class RN, R1 days apart with an approved serological Administrator. or R2 for MCF; test for MCF. (ii) The sheep and goats to be (B) Have not been vaccinated for (ii) The ruminants to be imported imported must be quarantined for at MCF; and must undergo post-importation least 15 days at a post-importation (C) Have had a negative result to an quarantine for at least 15 days at a quarantine facility designated and approved serological test for MCF 30 to facility designated and approved by the approved by the Administrator. 60 days prior to the date of export. Administrator. (iii) The sheep and goats must have a (ii) The ruminants to be imported (iii) The imported ruminants must negative result to an approved must be quarantined for at least 15 days have a negative result to an approved serological test for CA, SP, GP, and/or at a post-importation quarantine facility serological test for MCF during the post- CCPP during the post-importation designated and approved by the importation quarantine period. quarantine period. Administrator. (k) Contagious bovine (iii) The imported ruminants must (4) Regions classified as Risk Class R4 pleuropneumonia (CBPP)—(1) Regions have a negative result to an approved or RU for CA, SP, GP, and/or CCPP. classified as Risk Class R1 for CBPP. In serological test for MCF during the post- addition to the export certificate (i) In addition to the export certificate importation quarantine period. requirements of § 93.405, the certificate requirements of § 93.405, the certificate (3) Regions classified as Risk Class R3 of export for live cattle from regions of export for sheep and goats from for MCF. (i) In addition to the export classified as Risk Class R1 for CBPP regions that are classified as Risk Class certificate requirements of § 93.405, the must certify that the cattle to be R4 or RU for CA, SP, GP, and/or CCPP certificate of export for live ruminants imported: must certify that the sheep and goats to from regions classified as Risk Class R3 (i) Were born and resided only in be imported: for MCF must state that the ruminants regions classified as Risk Class RN or R1 (A) Have not been vaccinated for CA, to be imported: for CBPP; SP, GP, or CCPP; (A) Were born and resided only in (ii) Have not been vaccinated for (B) Have undergone a minimum 60- regions classified as Risk Class RN, R1, CBPP; day pre-embarkation quarantine; and R2 or R3 for MCF; (iii) Have undergone a minimum 30- (C) Have had negative results to two (B) Have not been vaccinated for day pre-embarkation quarantine; and approved tests conducted no sooner MCF; (iv) Have had a negative result to an than 30 days apart for CA, SP, GP and/ (C) Meet one of the following approved serological test for CBPP or CCPP, with the second test during the requirements: within 30 days prior to export. pre-embarkation quarantine period and (1) Have had a negative result to an (2) Regions classified as Risk Class R2 not more than 30 days before export. approved serological test for MCF 30 to for CBPP. (i) In addition to the export (ii) The sheep and goats to be 60 days prior to the date of export; or certificate requirements of § 93.405, the imported must be quarantined for at (2) Originate from a herd in which all certificate of export for live cattle from least 30 days at a post-importation ruminants in the herd over 6 months of regions classified as Risk Class R2 for quarantine facility designated and age have had a negative result with an CBPP must certify that the cattle to be approved by the Administrator. approved test for MCF within the imported: (iii) The sheep or goats to be imported previous 12 months; and (A) Were born and resided only in must have a negative result to an (D) Have been in a pre-embarkation regions classified as Risk Class RN, R1 approved serological test for CA, SP, GP, quarantine facility approved by the or R2 for CBPP; and/or CCPP during the post- Administrator for a minimum of 30 days (B) Have not been vaccinated for importation quarantine period. prior to export. CBPP; and (j) Malignant catarrhal fever—African (ii) The ruminants to be imported (C) Have had a negative result to an type (MCF)—(1) Regions classified as must be quarantined for at least 15 days approved serological test for CBPP 30 to Risk Class R1 for MCF. In addition to at a post-importation quarantine facility 60 days prior to the date of export. (ii) The imported cattle must be the export certificate requirements of designated and approved by the quarantined for at least 15 days at a § 93.405, the certificate of export for live Administrator. (iii) The imported ruminants must post-importation quarantine facility ruminants from regions that are have a negative result to an approved designated and approved by the classified as Risk Class R1 for MCF must serological test for MCF during the post- Administrator. certify that the ruminants to be importation quarantine period. (iii) The imported cattle must have a imported: (4) Regions classified as Risk Class R4 negative result to an approved (i) Were born and resided only in or RU for MCF. (i) In addition to the serological test for CBPP during the regions classified as Risk Class RN or R1 export certificate requirements of post-importation quarantine period. for MCF; § 93.405, the certificate of export for live (3) Regions classified as Risk Class R3 (ii) Have had a negative result to an ruminants from regions classified as for CBPP. (i) In addition to the export approved serological test for MCF Risk Class R4 or RU for MCF must certificate requirements of § 93.405, the within 30 days prior to the date of certify that the ruminants to be certificate of export for live cattle from export; and imported: regions classified as Risk Class R3 for (iii) Have not been vaccinated for (A) Originate from herds that have not CBPP must certify that the cattle to be MCF. been affected with MCF during the imported: (2) Regions classified as Risk Class R2 previous 12 months; (A) Were born and resided only in for MCF. (i) In addition to the export (B) Have not been vaccinated for regions classified as Risk Class RN, R1, certificate requirements of § 93.405, the MCF; R2 or R3 for CBPP; certificate of export for live ruminants (C) Have undergone a minimum of 60 (B) Have not been vaccinated for from regions classified as Risk Class R2 days pre-embarkation quarantine; and CBPP; for MCF must certify that the ruminants (D) During pre-embarkation (C) Meet one of the following to be imported: quarantine, have had negative results to requirements: 17058 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

(1) Have had a negative result to an imported had a positive result to the (EHD); Bovine Ephemeral Fever virus approved serological test for CBPP 30 to test, then: group (Kotonkan, Obodhiang) (BEF); 60 days prior to export; or (A) All positive pregnant female Rift Valley Fever virus (RVF); and/or (2) Originate from a herd in which all ruminant animals were removed from Wesselsbron(WB) virus—(1) Regions cattle in the herd over 6 months of age the group to be imported; and classified as Risk Class R1 and R2 for have had a negative result to an (B) All remaining ruminants (both BT, EHD, BEF, RVF, and WB virus. In approved test for CBPP within the positive and negative) were re-tested at addition to the export certificate previous 12 months; and least 30 days following the first test, and requirements of § 93.405, the certificate (D) Have been quarantined and all had negative, decreasing or stabilized of export for live ruminants from isolated for at least 30 days prior to test results. regions classified as Risk Class R1 and export from all animals not part of the (2) Regions classified as Risk Class R2 for BT, EHD, BEF, RVF, and/or WB group to be imported. R3, R4, and RU for aino and/or akabane virus must certify that the ruminants to (ii) The imported cattle must be virus. (i) In addition to the export be imported: quarantined for at least 15 days at a certificate requirements of § 93.405, the (i) Have resided for at least 60 days post-embarkation quarantine facility certificate of export for live ruminants prior to export only on premises located designated and approved by the imported from regions classified as Risk in regions classified as Risk Class RN, Administrator. Class R3, R4, or RU for aino and/or R1 or R2; (iii) The imported cattle must have a akabane must certify that the ruminants (ii) Have not been vaccinated for BT, negative result to an approved to be imported: EHD, BEF, RVF, or WB virus; serological test for CBPP during the (A) Do not originate from a herd that (iii) Have had a negative result to an post-embarkation quarantine period. has been known to be infected with aino approved serological test for BT, EHD, (4) Regions classified as Risk Class R4 and/or akabane virus within 12 months BEF, RVF, and/or WB virus within 30 or RU for CBPP. (i) In addition to the prior to the date of export; days prior to export. If any of the export certificate requirements of (B) Have not been vaccinated for aino ruminants in the group to be imported § 93.405, the certificate of export for live or akabane virus; test positive, then all the remaining (C) If offered for export during a time cattle from regions that are classified as ruminants in that group must qualify as of year when vectors are active, were Risk Class R4 or RU for CBPP must ruminants from a Risk Class R3, R4 or quarantined for at least 60 days prior to certify that the cattle to be imported: RU region according to paragraph (m)(2) export in a vector-proof facility (A) Originate from herds that have not of this section. approved by the Administrator and by been affected with CBPP during the (2) Regions classified as Risk Class the national veterinary services in the previous 12 months; R3, R4, and RU for BT, EHD, BEF, RVF, country of origin; and/or WB virus. (i) In addition to the (B) Have not been vaccinated for (D) If offered for export during a time export certificate requirements of CBPP; of year when insect vectors are not § 93.405, the certificate of export for live (C) Have undergone a minimum 60- active, at least 60 days has passed since ruminants from regions classified as day pre-embarkation quarantine; and the first killing frost of the season, and (D) During pre-embarkation (E) Were tested twice with negative Risk Class R3, R4 or RU for BT, EHD, quarantine, have had negative results to results at least 30 days apart with the BEF, RVF, and/or WB virus must certify two tests for CBPP conducted not less second test within 30 days prior to the that the ruminants to be imported: than 30 days apart with an approved date of export, using an approved (A) If offered for export during a serological test. serological test for akabane and/or aino season of the year when insect vectors (ii) The imported cattle must be virus. The tests must be conducted at are active, or less than 60 days after the quarantined for at least 30 days at a least 30 days apart. If any of the first killing frost in the fall of the year, post-importation quarantine facility ruminants in the shipment to be were quarantined and isolated from all designated and approved by the imported had a positive result to either animals not part of the group to be Administrator. test, then: imported for at least 60 days prior to (iii) The imported cattle must have a (1) All pregnant female ruminant embarkation in a vector-proof facility negative result to an approved animals were removed from the group to approved by the Administrator; serological test for CBPP during the be imported; and (B) If offered for export during a post-importation quarantine period. (2) All remaining ruminants (both season of the year when insect vectors (l) Aino and Akabane virus—(1) positive and negative) were re-tested at are not active, have remained on Regions classified as Risk Class R1 and least 30 days following the first test, premises located in areas where the first R2 for aino and/or akabane virus. In with negative, decreasing or stabilized killing frost in the fall occurred at least addition to the export certificate test results. 60 days prior to date of embarkation; requirements of § 93.405, the certificate (ii) The imported ruminants must be (C) Have not been vaccinated for BT, of export for live ruminants from quarantined for at least 15 days at a EHD, BEF, RVF, or WB virus; regions classified as Risk Class R1 and post-importation quarantine facility (D) Have had negative results to an R2 for aino and/or akabane must certify designated and approved by the approved serological test 30 to 60 prior that the ruminants to be imported: Administrator. to embarkation; (i) For at least 60 days have been only (iii) During the post-importation (E) If any of the ruminants in the on premises in regions classified as Risk quarantine period, all the imported group to be imported tests positive, then Class RN, R1 and R2; ruminants must have negative, the positive animals must be removed (ii) Have not been vaccinated for decreasing, or stabilized test results to from the group and all ruminants that akabane or aino virus; an approved serological test for akabane tested negative to the first test required (iii) Have had a negative result using and/or aino virus. in paragraph (m)(2)(i)(D) of this section an approved serological test for akabane (m) Bluetongue virus except for have had negative results to a second and/or aino virus within 30 days prior serotypes 10, 11, 13 and 17 (BT); approved serological test for BT, EHD, to the date of export. If any of the Epizootic Hemorrhagic Disease virus BEF, RVF, and/or WB virus within 30 ruminants in the shipment to be (Ibaraki) except serotypes 1 and 2 days prior to embarkation; and Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17059

(F) If any of the ruminants in the (B) Have not been vaccinated for NSD (A) Were quarantined for at least 60 group to be imported tests positive to virus; and days immediately prior to export in a the second test required in paragraph (C) During the pre-embarkation vector-proof facility approved the (m)(2)(i)(E) of this section, then: quarantine period, were tested twice, Administrator and the national (1) If during a season of year in the within 60 days prior to export and at Veterinary Services in the country of exporting region when insect vectors are least 30 days apart, with negative export; active, the remaining animals may not results, using an approved serological (B) Have not been vaccinated for be exported to the United States during test for NSD virus. If any ruminants in Cowdria riminantium, tick-borne the insect vector season; or the group to be imported tested positive encephalitis, and Louping Ill; and (2) If during a season of year when to the first serological test, then all (C) During the pre-embarkation insect vectors are not active: animals (positive and negative) were quarantine period, were tested twice, (i) All positive animals were removed retested at least 30 days following the within 60 days prior to export and at from the group to be imported; and previous test with negative, decreasing, least 30 days apart, with negative results (ii) All remaining animals were or stabilized test results to an approved using an approve serological test for negative to a third test at least 30 days serological test. Only those ruminants Cowdria ruminantium, tick-borne following the second test required in that are negative on both tests, or that encephalitis, and/or Louping Ill. paragraph (m)(2)(i)(E) of this section. were negative on virus isolation (ii) The imported ruminants must be (ii) Imported ruminants must be procedures may be exported to the quarantined for at least 30 days at a quarantined for at least 15 days at a United States. post-importation quarantine facility post-importation quarantine facility (ii) The imported ruminants must be designated and approved by the designated and approved by the quarantined for at least 15 days at a Administrator. Administrator if imported during a post-importation quarantine facility (iii) During the post-importation season of the year in the United States designated and approved by the quarantine period the imported when vectors are not active, and must Administrator. ruminants must be tested at least once, be quarantined for 60 days if imported (iii) During the post-importation with negative results, for Cowdria during a season of the year when vectors quarantine period, all the imported ruminantium, tick-borne encephalitis, are active in the United States. ruminants must have a negative test and/or Louping Ill using an approved (iii) During the post-importation result to an approved serological test for serological test. quarantine period, all the imported NSD. (p) Theileria—(1) Regions classified ruminants must have negative results to (o) Cowdria ruminantium as Risk Class R1 and R2 for Theileria. an approved serological test for BT, (Heartwater), tick-borne encephalitis, In addition to the export certificate EHD, BEF, RVF, and/or WB virus. (n) Nairobi Sheep Disease (Dugbe, and/or Louping Ill—(1) Regions requirements of § 93.405, the certificate Ganjam) virus (NSD)—(1) Regions classified as Risk Class R1 and R2 for of export for the live ruminants from classified Risk Class R1 and R2 for NSD. Cowdria ruminantium, tick-borne regions that are classified as Risk Class In addition to the export certificate encephalitis, and Louping Ill. In R1 and R2 for Theileria must certify that requirements of § 93.405, the certificate addition to the export certificate the ruminants to be imported: of export for live ruminants from requirements of § 93.405, the certificate (i) For at least 1 year immediately regions classified as Risk Class R1 and of export for live ruminants from prior to export, have resided only on R2 for NSD must certify that the regions classified as Risk Class R1 and premises located in regions classified as ruminants to be imported: R2 for Cowdria ruminantium, tick-borne Risk Class RN, R1 or R2; (i) Have resided for at least 60 days on encephalitis, and Louping Ill must (ii) Have not been vaccinated for premises located in regions classified as certify that the ruminants to be Theileria; and Risk Class RN, R1 or R2 for NSD; imported: (iii) Had a negative result to an (ii) Have not been vaccinated for NSD; (i) Have resided on premises located approved serological test for Theileria (iii) Have had a negative result to an in Risk Class RN, R1 and R2 regions for within 30 days prior to export. approved serological test for NSD virus Cowdria ruminantium, tick-borne (2) Regions classified as Risk Class within 30 days prior to export. If any of encephalitis, or Louping Ill for at least R3, R4, and RU for Theileria. (i) In the ruminants tests positive, then all the 60 days immediately prior to export; addition to the export certificate remaining ruminants in the group to be (ii) Have not been vaccinated for requirements of § 93.405, the certificate imported must meet the requirements Cowdria ruminantium, tick-borne of export for live ruminants imported for ruminants from Risk Class R3, R4 or encephalitis, or Louping Ill; and from regions classified as Risk Class R3, RU regions, as set forth in paragraph (iii) Have had a negative result to an R4, and RU for Theileria must certify (n)(2) of this section. approved serological test for Cowdria that the ruminants to be imported: (2) Regions classified as Risk Class ruminantium, tick-borne, and/or (A) Were quarantined for at least 60 R3, R4, and RU for NSD. (i) In addition Louping Ill within 30 days prior to days prior to export in a vector-proof to the export certificate requirements of export. facility approved by the Administrator § 93.405, the certificate of export for live (2) Regions classified as Risk Class and the National Veterinary services of ruminants from regions classified as R3, R4, and RU for Cowdria the country of export; Risk Class R3, R4, or RU for NSD virus ruminantium, tick-borne encephalitis, (B) Have not been vaccinated for must certify that the ruminants to be and/or Louping Ill. (i) In addition to the Theileria; and imported: export requirements of § 93.405, the (C) During the pre-embarkation (A) Were quarantined from all certificate of export for ruminants quarantine period, we were tested twice, animals not part of the group to be imported directly from regions at least 30 days apart, with negative imported, for at least 60 days prior to classified as Risk Class R3, R4, and RU results using an approved serological export, in a vector-proof facility for Cowdria ruminantium, tick-borne test for Theileria. approved by the Administrator and by encephalitis, and/or Louping Ill must (ii) The imported ruminants must be the national Veterinary Services in the certify that the ruminants to be quarantined for at least 30 days at a country of export; imported: port-importation quarantine facility 17060 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules designated and approved by the certificate requirements of § 93.405, the BPF must certify that the ruminants to Administrator. certificate of export for live ruminants be imported: (iii) During the post-importation from regions that are classified as Risk (i) Have resided for their entire life quarantine period, the imported Class R1 and R2 for Besnoitia besnoiti, only on premises located in regions ruminants must be tested at least once LSD, and/or Parafilaria bovicola must classified as Risk Class RN, R1 and R2 with negative results using an approved certify that the ruminants to be for NTT-Trypanosomas, TBF, and BPF; serological test for Theileria. imported: (ii) Have not been vaccinated for NTT- (q) African (Salivarian or Tsetse- (i) For at least 60 days immediately Trypanosomas, TBF, or BPF; and transmitted) Trypanosomes— prior to export, have resided only on (iii) Had a negative result to an (1) Regions classified as Risk Class R1 premises located in Risk Class RN, R1 approved serological test for NTT- and R2 for African trypanosomes. In and R2 regions for Besnoitia besnoiti, Trypanosomas, TBF, and/or BPF within addition to the export certificate LSD, and/or Parafilaria bovicola; 30 days prior to export. requirements of § 93.405, the certificate (ii) Have not been vaccinated for (2) Regions classified as Risk Class of export for live ruminants from Besnoitia besnoiti, LSD, or Parafilaria R3, R4, and RU for NTT-Trypanosomas, regions that are classified as Risk Class bovicola; and TBF, and/or BPF. (i) In addition to the R1 and R2 for African trypannosomes (iii) Had a negative result to an export certificate requirements of must certify that the ruminants to be approved serological test for Besnoitia § 93.405, the certificate of export for live imported: besnoiti, LSD, and/or Parafilaria ruminants imported from regions that (i) Have resided only on premises bovicola within 30 days prior to export. are classified as Risk Class R3, R4, and/ located in Risk Class RN, R1 or R2 (2) Regions classified as Risk Class or RU for NTT-Trypanosomas, TBF, regions for trypanosomes and tsetse flies R3, R4, and RU for Besnoitia besnoiti, and/or BPF must certify that the (Glossina spp.) for their entire life; LSD, and/or Parafilaria bovicola. (i) In ruminants to be imported: (ii) Have not been vaccinated for addition to the export certificate (A) Were quarantined from all trypanosomes; and requirements of § 93.405, the certificate animals not part of the group to be (iii) Have had a negative result to an of export for live ruminants imported imported, for at least 60 days prior to approved serological test for African from regions that are classified as Risk export, in a vector-proof facility trypanosomes within 30 days prior to Class Regions R3, R4, and/or RU for approved by the Administrator and the export. Besnoitia besnoiti, LSD, and/or National Veterinary Services of the (2) Regions classified as Risk Class Parafilaria bovicola must certify that the country of export; R3, R4, and RU for African (B) Have not been vaccinated for NTT- ruminants to be imported: trypanosomes. (i) In addition to the Trypanosomas, TBF, or BPF; and (A) Were quarantined, for at least 60 export certificate requirements of (C) During the pre-embarkation days prior to export, from all animals § 93.405, the certificate of export for quarantine period, were tested twice at not part of the shipment, in a vector- ruminants imported from regions least 30 days apart with negative results, proof facility approved by the classified as Risk Class R3, R4, and RU using an approved serological test for Administrator; for African trypanosomes and Tsetse NTT-Trypanosomas, TBF, and/or BPF. (B) Have not been vaccinated for flies (Glossina spp.) must certify that the (ii) If imported during a season of the Besnoitia besnoiti, LSD, or Parafilaria ruminants to be imported: year when vectors are not active in the (A) Originated from premises that bovicola; and United States, the ruminants imported have not had trypanosomiasis diagnosed (C) During the pre-embarkation must be quarantined for at least 15 days during the previous 24 months; quarantine period, were tested twice at at a post-importation quarantine facility (B) Were quarantined for least 60 days least 30 days apart with negative results, designated and approved by the prior to export in a vector-proof facility using an approved serological test for Administrator approved by the Administrator and the Besnoitia besnoiti, LSD, and/or (iii) if imported during a season of the National Veterinary Services of the Parafilaria bovicola. year when vectors are active in the country of export; (ii) The imported ruminants must be United States, the ruminants imported (C) Have not been vaccinated for quarantined for at least 15 days at a must be quarantined for at least 60 days trypanosomes; and post-importation quarantine facility at a post-importation quarantine facility (D) During the pre-embarkation designated and approved by the designated and approved by the quarantine period, had negative results Administrator. Administrator. to an approved serological test for (iii) During the post-importation (iv) During the post-importation trypanosomes. quarantine period the ruminants must quarantine period the imported (ii) The imported ruminants must be be tested at least once, with negative ruminants must be retested at least once quarantined for at least 30 days at a results, using approved serological tests. with negative results to an approved post-importation quarantine facility (s) Trypanosoma spp. transmitted by serological test for NTT-Trypanosomas, designated and approved by the vectors other than tsetse flies (Glossina TBF, and/or BPF. Administrator. spp.) (NTT-Trypanosomas), tick-borne (t) Vesicular Stomatitis virus (VSV)— (iii) During the post-importation fever due to Erlichia (Cytoecetes) (1) Regions classified as Risk Class R1 quarantine period, the imported phagocytophilia (TBF), bovine for VSV. In addition to the requirements ruminants must be tested at least once infectious petechial fever (Ondiri of § 93.405 of this part, the certificate of for trypanosomes, with negative results, disease) due to Erlichia(Cytoecetes) export for live ruminants from regions using approved serological tests. ondiri (BPF)—(1) Regions classified as that are classified as Risk Class R1 for (r) Globidiosis due to Besnoitia Risk Class R1 and R2 for NTT- VSV must certify that the ruminants to besnoiti, Lumpy Skin Disease (LSD) Trypanosomas, TBF, and/or BPF. In be imported: virus, and/or Parafilaria bovicola addition to the export certificate (i) Have resided for at least 60 days (parafilariasis)—(1) Regions classified requirements of § 93.405, the certificate prior to export only on premises located as Risk Class R1 and R2 for Besnoitia of export for live ruminants from in Risk Class RN or R1 regions for VSV; besnoiti, LSD, and/or Parafilaria regions classified as Risk Class R1 and and bovicola. In addition to the export R2 for NTT-Trypanosomas, TBF, and/or (ii) Have not been vaccinated for VSV. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17061

(2) Regions classified as Risk Class R2 agreement to use HSTAIC will not be (ii) Each applicant for the importation for VSV. In addition to the requirements offered to or entered into with, any of animals through HSTAIC must make of § 93.405 of this part, the certificate of person who has debts owing to APHIS a deposit of $32,000 in the form of a export for live ruminants imported from that have not been paid by the date certified check or money order, payable regions that are classified as Risk Class specified in APHIS’s original billing in U.S. funds. The deposit of each R2 for VSV must certify that the notification to the person. Any person applicant who is not given the ruminants to be imported: who has debts owing to APHIS that opportunity to use HSTAIC will be (i) Have resided for at least 60 days have not been paid by the date specified returned to the applicant at the end of prior to export only on premises located in APHIS’s original billing notification the calendar year of the prospective in Risk Class RN, R1 or R2 regions for to that person will be removed from the importation, or whenever the applicant VSV; current priority list. An importer removes his or her name from the (ii) Have not been vaccinated with granted the exclusive right to use priority list described in paragraph any live attenuated vaccines for VSV; HSTAIC may include in his or her (b)(4) of this section. The Animal and and allotted number, animals of the same Plant Health Inspection Service will (iii) Have not been vaccinated with species belonging to other persons draw on the deposit of the applicant inactivated vaccines for VSV within 60 interested in importing animals through whose application is selected, to pay for days prior to export. HSTAIC, except that llamas and alpacas the costs of preparing and maintaining (3) Regions classified as Risk Class may be included in the same HSTAIC in readiness for the applicant’s R3, R4, and RU regions for VSV. (i) In importation. However, APHIS will deal animals. A charge of $1,067 will be addition to the requirements of § 93.405 exclusively with the importer in whose made for each day that HSTAIC is not of this part, the certificate of export for name the application for use of HSTAIC available to another importer, starting live ruminants imported from regions was submitted. The Animal and Plant on the date the cooperative-service that are classified as Risk Class R3, R4, Health Inspection Service will hold this agreement is delivered to the address and/or RU for VSV must certify that the importer solely responsible for all costs listed on the importer’s HSTAIC ruminants to be imported: (excepting capital expenditures at application, and ending either with the (A) Have not been vaccinated with HSTAIC) incurred during the animal day that APHIS receives the signed any live attenuated vaccines for VSV; qualification process. The animal cooperative-service agreement or the (B) Have not been vaccinated with qualification process begins on the date day the applicant notifies APHIS in inactivated vaccines for VSV within 60 the cooperative-service agreement is writing that he or she does not intend days prior to export; delivered to the address listed on the to sign the cooperative-service (C) Have not been located on any importer’s HSTAIC application, for the agreement, up to a maximum of 30 days. premises where VSV has occurred importer’s signature, if HSTAIC is not A cooperative-service agreement will be within 60 days prior to export; and available to other importers, up to a deemed to have been delivered when (D) If exported during a season of the maximum of 30 days. A cooperative- the importer signs the U.S. Postal year when insect vectors were active: service agreement will be deemed to Service domestic return receipt, or (1) Were quarantined and isolated have been delivered when the importer refuses delivery of the cooperative- from all other animals not part of the signs the U.S. Postal Service domestic service agreement by the U.S. Postal shipment for at least 30 days prior to return receipt, or the importer refuses Service, or the cooperative-service export in a vector-proof facility delivery of the cooperative-service agreement is returned by the U.S. Postal approved by the Administrator; and agreement by the U.S. Postal Service, or Service as either unclaimed or (2) During the pre-embarkation the cooperative-service agreement is undeliverable. quarantine period, had negative results returned by the U.S. Postal Service as (2)(i) During the first seven days of to an approved serological test for VSV either unclaimed or undeliverable. December,10 APHIS will hold a lottery, within 14 days prior to export. HSTAIC can accommodate a finite randomly drawing the names of (ii) If imported during a season of the number of animals at one time, but the applicants in an order that will year when insect vectors are active maximum allowed for a particular determine the order in which they will within the United States, the imported importation will vary, depending on the be offered use of HSTAIC for an ruminants: size of the species. The Animal and importation during the next calendar (1) Must be quarantined for at least 15 Plant Health Inspection Service will year. To be included in the annual days at a post-importation quarantine specify this figure in the cooperative- December lottery, applications must facility designated and approved by the service agreement, reproduced in reach the Import-Export Animals Staff, Administrator; and paragraph (d) of this section. Veterinary Services, no earlier than (2) During the post-importation (b) Scheduling. Applications from October 1 and no later than October 15 quarantine period, must have negative prospective users of HSTAIC are of that year. results to an approved serological test processed according to the following (ii) One application is required for for VSV. system: each importation proposed. Deposits § 93.416 Importation of ruminants through (1) All applications for use of required by paragraph (b)(1)(ii) of this the Harry S Truman Animal Import Center HSTAIC. (i) To qualify to use HSTAIC, section must be received by APHIS at (HSTAIC). an importer must submit a completed least 7 calendar days prior to the date (a) Exclusive right to use HSTAIC. The application,9 providing estimates when of the lottery. Animal and Plant Health Inspection exact information as required on the (3) The priority list established by the Service will enter into a cooperative- application form is unavailable. annual December lottery will remain service agreement with only one effective from January 1 through importer for each importation through 9 Application forms are available from, and must December 31 of the next calendar year, the Harry S Truman Animal Import be submitted to Import/Export Animals Staff, National Center for Import and Export, Veterinary 10 The Animal and Plant Health Inspection Center (HSTAIC). Applications for the Services, Animal and Plant Health Inspection Service will publish a notice announcing the exact HSTAIC lottery will not be accepted Service, 4700 River Road Unit 39, Riverdale, MD date in the Federal Register at least 30 days in from, and a cooperative-service 20737–1231. advance of the December drawing. 17062 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules superseding all previous lists. Which agency of the United States Government HSTAIC, in accordance with the year’s list is used is governed by the must submit its application in procedures in this section. date exclusive use of HSTAIC is offered accordance with this section, except (2) The importer may not abrogate and not by the date the applicant’s that, an agency of the United States his/her responsibility for costs incurred animals are scheduled to arrive at Government must enter into an after the signing of the cooperative- HSTAIC. interagency agreement with APHIS for a service agreement, regardless of any (4) The names of all applicants whose deposit of $32,000 by certified check or occurrences that prevent the applications have reached the Import- money order, payable in U.S. funds. importation from proceeding as Export Animals Staff, Veterinary HSTAIC importations by agencies of the planned. Services, no earlier than October 1 and United States government will be (3) The importer signing the no later than October 15 (see paragraphs limited to one per year, except when cooperative-service agreement returned (b) (1) and (2) of this section), and HSTAIC is available and the Import- to APHIS is responsible for paying all whose deposits have reached APHIS at Export Animals Staff, Veterinary costs, excluding capital expenditures at least 7 calendar days prior to the date Services, has received no other HSTAIC, incurred in qualifying the of the lottery, will be drawn during the applications for its use during that year. specified animals for importation December lottery. The order in which (c) Responsibilities of the Applicant through HSTAIC. A partial list of costs names appear on the priority list will Selected. By certified mail, return for which the importer must assume correspond to that established by the receipt requested, APHIS will send a responsibility includes: expenses for lottery. If the person first offered the cooperative-service agreement to the preparing and maintaining HSTAIC in right to use HSTAIC does not ensure applicant being offered the exclusive readiness for the importation; expenses receipt of the cooperative-service right to use HSTAIC, as provided in for sentinel animals in the United agreement by the Import-Export paragraph (d) of this section. The States, when required, and for tested Animals Staff, Veterinary Services, applicant must, within 30 days of animals prevented, for any reason, from within 30 days of receiving the receipt, sign and ensure that the Import- moving from HSTAIC elsewhere within cooperative-service agreement, APHIS Export Animals Staff, Veterinary the United States; laboratory tests; will void that offer, and make an offer Services, receives the cooperative- medical treatment; official travel by to the applicant next on the priority list. service agreement. The cooperative- APHIS personnel, including per diem The Animal and Plant Health Inspection service agreement must be accompanied expenses in the country from which Service will limit importations to one by a certified check or money order, or animals are being exported, when per importer for the period an irrevocable letter of credit (the letter required; courier services to transport encompassing the calendar year for of credit having an effective date 90 test samples to the Foreign Animal which the lottery is held and the days after the animals’ scheduled Disease Diagnostic Laboratory, when following two calendar years, except release date from HSTAIC), payable in required; salaries of HSTAIC personnel; when no other lottery participants are U.S. funds, for the amount specified in all supplies for animals care, prepared to use HSTAIC during the time the cooperative-service agreement. Any maintenance, and testing during the it would be available in those years. The funds remaining from the $32,000 quarantine and in the post-quarantine priority list established during the deposit will be applied to the cleaning and disinfection of HSTAIC; December lottery will remain in effect quarantine costs, and will be deducted utilities and overhead, including during the calendar year following the from the balance due with the support staff, during the quarantine and lottery, and will take precedence over cooperative-service agreement. For post-quarantine cleanup. any applications received after October importations requiring use of a pre- (4) Capital expenditures at HSTAIC 15th. Applications received after embarkation quarantine facility, constitute the only costs for which the October 15th will be added to the physical plans for the facility, including importer will not be held responsible. (5) For costs incurred during any stage priority list, with precedence site-specific blueprints and location, of the importation through HSTAIC— established by the order in which the must be included when the cooperative- that is, costs not calculated into the Import-Export Animals Staff, Veterinary service agreement is returned to the amount collected from the importer in Services, receives them. Import-Export Animals Staff, Veterinary (5) If the Import-Export Animals Staff, Services. accordance with the cooperative-service Veterinary Services, does not receive (1) An importer interested in animals agreement—APHIS will bill the more than one application between ineligible for importation because importer at a later date. Payment will be October 1st and October 15th for the officials in the exporting country or area due upon receipt of the bill. (6) The Animal and Plant Health December lottery, the December lottery will not allow APHIS to provide the Inspection Service will return to the for that year will be canceled, and services prescribed in the cooperative- importer any part of the money remitted APHIS will grant the exclusive right to service agreement, may, upon with the cooperative-service agreement use HSTAIC for an importation during notification of this ineligibility from set forth in paragraph (d) of this section the next calendar year in the order APHIS, propose to substitute animals that is not used to cover the non-capital applications are received. available from another location. If this (6) The Secretary of Agriculture may importer has not returned the signed costs of the importation through grant priority over other applications to cooperative-service agreement within HSTAIC. (d) Cooperative-Service Agreement. an application from an agency of the the 30 days specified in the cooperative- Each importer being granted the right to United States Government, if for an service agreement, APHIS will return use HSTAIC must sign, and comply importation potentially of value to the any portion of the importer’s deposit with, the cooperative-service agreement general public, and if received before that has not been expended. In that case, with APHIS. A sample cooperative- July 15 of the year preceding the the applicant next in priority will be service agreement for importers other proposed importation.11 However, an offered the exclusive right to use than agencies of the United States 11 If the Secretary grants priority to an application will publish a notice in the Federal Register prior government is reproduced in this from an agency of the United States Government, to October 1 of the year preceding the proposed paragraph. (Agencies of the United the Animal and Plant Health Inspection Service importation. States government being granted the Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17063 right to use HSTAIC must enter into an HSTAIC; utilities and overhead, including and handling of animals on premises of interagency agreement with APHIS.) support staff, during the quarantine and post- origin, in the PEQF when quarantine in a The amount of money the importer must quarantine cleanup.) PEQF is required, and in HSTAIC. advance, left blank in the following 5. To obtain from foreign government 2. To inform the importer of any officials authorizations granting Animal and quarantined animals in the PEQF or in sample, will depend on figures unique Plant Health Inspection Service personnel HSTAIC that fail to qualify for entry into the to a particular importation. This amount free access to the PEQF, when quarantine in United States, and to inform the importer will be specified in the cooperative- a PEQF is required, and permits for export. that he/she must assume responsibility for service agreement the importer receives. 6. To secure from animal carriers their disposal. permission for Animal and Plant Health 3. To finance capital expenditures at Cooperative-Services Agreement Between Inspection Service personnel to accompany HSTAIC without charging the importer. (Name of Importer) and the United States the animals to the PEQF, when quarantine in 4. To account for all money disbursed from Department of Agriculture, Animal and a PEQF is required, and from the PEQF to the amount remitted, and to provide the Plant Health Inspection Service HSTAIC. importer with a complete written accounting The importer, llllllll, wishes to 7. To maintain and operate the PEQF, upon termination of this cooperative-service qualify animals for importation into the when quarantine in a PEQF is required, in agreement. United States. The United States Department compliance with 9 CFR 93.417 of the Code 5. To refund to the importer any part of the of Agriculture, Animal and Plant Health of Federal Regulations. money remitted with this cooperative-service Inspection Service, administers the Harry S 8. To accept as final the findings of the agreement that is not used to cover the non- Truman Animal Import Center (HSTAIC), a Administrator, Animal and Plant Health capital costs of the importation through facility through which the importer may Inspection Service, on the animals’ eligibility HSTAIC. import animals into the United States. to enter the PEQF, when quarantine in a Both parties agree: To effect this importation, both parties PEQF is required, to enter HSTAIC, and to be 1. That this cooperative-service agreement agree to the following terms: released from HSTAIC. is effective upon signature by both parties. The importer agrees: 9. To follow procedures prescribed by the 2. That this cooperative-service agreement 1. To have this cooperative-service Animal and Plant Health Inspection Service, will not be signed by the Administrator if the agreement in the office of the Animal and appropriate to the disease and pest status of Import-Export Animals Staff, Veterinary Plant Health Inspection Service’s Import- the quarantined animals. (When quarantine Services, Animal and Plant Health Inspection Export Animals Staff, Veterinary Services, in a PEQF is required, the presence in the Service, has not received this signed within 30 days of the date of receipt, PEQF of even one animal either exposed to, cooperative-service agreement, including the evidenced by the postal return-receipt. or infected with, rinderpest, foot-and-mouth specified remittance for the amount due, by 2. To remit with the cooperative-service disease, hog cholera, African swine fever, 4:30 p.m. on the thirtieth calendar-day after agreement a certified check, money order, or swine vesicular disease, or certain other the date on the United States Postal Service’s irrevocable letter of credit having an effective contagious, exotic diseases, automatically return receipt, evidencing its receipt by the date that extends 90 days beyond the disqualifies all animals in the PEQF from importer. animals’ scheduled release from HSTAIC, entering HSTAIC. The presence in HSTAIC 3. That this cooperative-service agreement payable in U.S. funds to the United States of even one animal either exposed to, or will not be signed by the Administrator if the Department of Agriculture, Animal and Plant infected with, one of the diseases referred to cooperative-service agreement is not Health Inspection Service, in the amount of in this paragraph, automatically disqualifies accompanied by the physical plans for the $llllll. (This amount represents the all animals in HSTAIC from moving PEQF, including its location and site-specific estimated cost (except capital expenditures at anywhere within the United States after the blueprints (except when quarantine in a HSTAIC) of qualifying the animals for period in quarantine.) PEQF is not required). importation through HSTAIC, less any 10. To assume responsibility for disposal of 4. That this cooperative-service agreement unused portion of the $32,000 deposited in quarantined animals that do not qualify to will be voided if the Administrator, Animal conjunction with the application for the move into or within the United States. (In the and Plant Health Inspection Service, exclusive right to use HSTAIC. case of animals disqualified while determines that the importer has not 3. To limit to llllll the number of quarantined in HSTAIC, the Animal and completed arrangements with the responsible animals, species llllll transported to Plant Health Inspection Service will stipulate officials in the exporting country by 4:30 HSTAIC for an importation scheduled to the conditions under which the disqualified p.m. on the date 42 calendar-days after the begin on or about llllll and to end animals in HSTAIC must be destroyed. The importer’s signing of this cooperative-service with the animals’ release from HSTAIC, importer must, within 10 days of notification agreement. scheduled for llllll. from the Animal and Plant Health Inspection 5. That, if both parties agree, this 4. To assume liability for all costs (except Service, remove from the PEQF or HSTAIC, cooperative-service agreement may be capital expenditures at HSTAIC) attributable animals untreatable or treated for, but not amended in writing. to preparing and maintaining HSTAIC in cured of, a communicable disease other than 6. That either party may terminate this readiness for the importation, and to foot-and-mouth disease or any of certain cooperative-service agreement upon giving qualifying animals for and through other exotic diseases. Animals removed from 30 days written notice to the other party, but quarantine in the pre-embarkation quarantine HSTAIC must be moved out of the United premature termination will not relieve the facility (PEQF), when quarantine in a PEQF States or be destroyed under conditions importer of responsibility for costs incurred, is required, and in HSTAIC for importation stipulated by the Animal and Plant Health as provided in this cooperative-service into the United States. (A partial list of these Inspection Service.) agreement, nor will it relieve the Animal and costs would include expenses for sentinel 11. To assume responsibility for all costs Plant Health Inspection Service of animals in the United States and for tested the Animal and Plant Health Inspection responsibility for providing the importer animals prevented, for any reason, from Service incurs during this importation, with a complete written accounting of money moving from HSTAIC elsewhere within the excluding capital expenditures at HSTAIC. disbursed from the amounts remitted. United States; laboratory tests; medical 12. To pay, upon receipt, post-quarantine 7. That during the performance of this treatment; official travel by Animal and Plant billings incurred during this importation, for cooperative-service agreement, the importer Health Inspection Service personnel, costs exceeding the amount remitted with agrees to be bound by the Equal Employment including per diem expenses in the country this cooperative-service agreement plus the Opportunity and Nondiscrimination from which the animals are being exported; initial $32,000 deposit. provisions set forth in Exhibit A and the courier services to transport test samples to The Animal and Plant Health Inspection Nonsegregation of Facilities provisions set the Foreign Animal Disease Diagnostic Service Agrees: forth in Exhibit B,1 which are attached to and Laboratory; salaries of HSTAIC personnel; all 1. To provide the personnel required to supplies for animal care, maintenance, and perform inspections, laboratory procedures, 1 1 Import-Export Animal Staff, National Center testing during the quarantine and in the post- and examinations, and to provide on-site for Import and Export, Veterinary Services, APHIS, quarantine cleaning and disinfection of supervision of the isolation, quarantine, care Continued 17064 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules made part of this cooperative-service cooperative-service agreement, as water and waste effluents from local agreement. provided in § 93.430(d), is not approved livestock or poultry. Water and waste 8. That no member of, or delegate to, by APHIS, the importer may use an effluents from the facility must be Congress may participate in, or benefit from, alternative PEQF, provided it is disposed of in a manner determined by this cooperative-service agreement. lllllllllllllllllllll approved by the Animal and Plant the Administrator to be adequate to Date Health Inspection Service during the 42 ensure no exposure to local livestock or lllllllllllllllllllll days following the date the importer poultry. Importer signs the cooperative-service agreement. (2) Building. (i) The exterior of the lllllllllllllllllllll If a PEQF closes down or loses its building must be of durable low Date ‘‘approved’’ status for any reason, maintenance, waterproof type lllllllllllllllllllll APHIS may approve a replacement construction that will withstand Administrator, Animal and Plant Health following the method specified in this repeated cleaning and disinfecting. Inspection Service, United States Department paragraph (a)(4). of Agriculture. (ii) Roofs must be watertight. The (5) Permission to place ruminants in styling and configuration of the roof of § 93.417 Pre-embarkation quarantine the foreign PEQF shall be given to any the ruminant holding building must facility; criteria and standards for approval. person who has received permission to provide for optimum air circulation Criteria for establishment of a pre- import ruminants through the Harry S throughout the facility. embarkation quarantine facility outside Truman Animal Import Center, unless (iii) The interior finish of the building the United States for the purpose of the Administrator determines that must be durable, washable, and of low importing ruminants into the United sufficient grounds exist whereby such maintenance type construction. The States that are eligible for importation person may be denied such permission. floor must be concrete with no cracks or only through the Harry S Truman (6) Fees charged by the owner or crevices. Animal Import Center are as follows: operator for the use of such facility shall (iv) Mesh double screens must protect (a) Establishment. (1) The be provided in private agreements all open regions, so that insects cannot Administrator may enter into an between the owner or operator of the gain access to the ruminant holding facility and the owners of the ruminants agreement with one or more parties for region. If the ruminants are removed proposed for importation. Such fees the establishment of such a facility from the double-screened building shall be nondiscriminatory and pursuant to the standards in paragraph before export to the HSTAIC, or if the reasonable as determined by the (b) of this section. United States Department of Agriculture Administrator. (2) To qualify for designation as a pre- Veterinarian in Charge of the quarantine (7) Approval of any approved PEQF embarkation quarantine facility (PEQF) operation determines that insects may be withdrawn at any time by the for a specifically authorized capable of transmitting communicable Administrator, upon his or her importation, the facility must meet the animal diseases are entering the determination that any requirement of requirements of paragraph (b) of this ruminant holding region, APHIS will this section is not being met. Before section. require implementation of a program of such action is taken, the operator of the (3) All costs associated with the insect vector control. This vector control facility will be informed of the reasons establishment and operation of such a program will involve treating for the proposed action and afforded pre-embarkation quarantine facility ruminants, building interiors, and opportunity to present his or her views shall be borne by the owner or operator environs with United States thereon in accord with rules of practice of such facility. Environmental Protection Agency- adopted by the Administrator. Upon (4) The Animal and Plant Health registered pesticides. The pesticides withdrawal of approval, the operator, Inspection Service requires that the must be used in the manner prescribed upon request, shall be afforded importer submit the physical plans for on the United States Environmental opportunity for a hearing with respect to the PEQF for which he/she is requesting Protection Agency-approved label, and the merits or validity of such action; but approval. The physical plans must in accordance with the requirements of such withdrawal or refusal shall include location of the facility and site- the government of the country in which continue in effect unless otherwise specific blueprints. The importer must the PEQF is located. send these physical plans, due with the ordered by the Administrator. Rules of practice concerning the hearing will be (v) Stalls, pens, and runways must be cooperative-service agreement as constructed of sufficient height and provided in § 93.430(d) to the Import- adopted by the Administrator. (b) Standards for approval of pre- strength to confine and restrain all Export Animals Staff, National Center ruminants simultaneously for daily for Import-Export, Veterinary Services, embarkation quarantine facilities—(1) Location. (i) The PEQF must be in a veterinary examinations. Animal and Plant Health Inspection (vi) At least 70-foot-candle lighting Service, United States Department of region isolated from ruminants, swine, and poultry. It must be located near the must be provided in the inspection Agriculture, 4700 River Road Unit 39, region. A minimum light of 30-foot- Riverdale, MD 20737–1231. Approval of point of embarkation: A dock, if the ruminants will travel by ocean vessel; candle must be available in all other a PEQF will expire at the end of the regions of the facility. specifically authorized quarantine. an airport, if the ruminants will travel by plane. (vii) A dipping vat of a concrete pit Subsequent importers granted use of type with inspection chute, holding HSTAIC and proposing to use one of the (ii) The ruminants’ route from the PEQF to the point of embarkation must pen, dripping pen, and post-drip region existing PEQFs must apply for approval similar to USDA Extension Plan 5940, as if for a new facility. No more than be limited to regions free of ruminants, revised, must be provided.12 one PEQF will receive approval for a swine, and poultry. specific HSTAIC importation. If the (iii) The facility must be so situated 12 PEQF specified in the signed that there will be no contact between Copies of USDA Extension Plan 5940, revised, ruminants held in the facility with any may be obtained from the Import-Export Animals Staff, National Center for Import and Export, USDA, will send each importer copies of Exhibits other species of animals. Animal and Plant Health Inspection Service, United A and B along with the cooperative-services (iv) The facility must be so situated States Department of Agriculture, 4700 River Road agreement. that it will be free from contact with Unit 39, Riverdale, MD 20737–1231. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17065

(viii) The waste management system (v) If lunch is to be eaten within the 93.509 Movement from conveyances to must be carefully designed to meet all facility, a lunch room must be provided quarantine station. applicable sanitation and quarantine and all food entered into the facility 93.510 Swine quarantine facilities. requirements and the existing must be approved by the supervising 93.511 Quarantine stations, visiting restricted; sales prohibited. environmental standards of the country United States government veterinarian. 93.512 Milk from quarantined swine. in which the pre-embarkation (vi) A separate room containing the 93.513 Manure from quarantined swine. quarantine facility is located. equipment for preparation and 93.514 Appearance of disease among swine (3) Fencing. (i) The outer perimeter of packaging of laboratory specimens with in quarantine. all facilities must be surrounded by a adequate office space, as determined by 93.515 Requirements for importation of live fence that must be of sufficiently small the Administrator, to perform his or her swine from various risk class regions. mesh as to preclude the entrance of duties must be provided for the 93.516 Importation of swine through the small farm animals, including dogs, and supervising veterinary official. All Harry S Truman Animal Import Center of such height and strength as to prevent records, equipment, and other materials (HSTAIC). 93.517 Pre-embarkation quarantine facility; entrance of larger animals. This fence used in the facility must be maintained criteria and standards for approval. must be located at least 200 feet from within the quarantine facility for the the building in which quarantined entire quarantine period. Subpart EÐSwine ruminants are to be held, except that, in (vii) A separate area situated apart an urban or industrial region the from the ruminant holding area must be § 93.500 Definitions. location of the fence may be less than provided for necropsies, and a means Wherever in this subpart the 200 feet as determined by the for the removal of the carcasses of dead following terms are used, unless the Administrator, if such action will not ruminants must be provided without context otherwise requires, they shall be increase the risk that communicable breaking quarantine security. construed, respectively, to mean: diseases of livestock or poultry will be (viii) A ruminant receiving area and a Accredited veterinarian. A disseminated from the facility. chute or stocks for restraint during veterinarian approved by the (ii) In regions affected by cattle fever examination and veterinary inspection, Administrator in accordance with the ticks, all such facilities must be double as determined to be appropriate by the provisions of part 161 of this chapter to fenced with the inner perimeter fence Administrator, to permit examination of perform functions specified in parts 1, located at least 15 feet from the outer the ruminant, must be provided. 2, 3, and 11 of subchapter A, and perimeter fence. When double fencing is (ix) Feed must be stored in such a subchapters B, C, and D of this chapter, required, the space between the outer manner that replenishment during the and to perform functions required by and inner perimeter fences must be kept quarantine period does not require cooperative State-Federal disease free from all foliage at all times. transporting vehicles to enter the control and eradication programs. (iii) The outer fence of the facility quarantine area. Adjacent regions. Any defined must be posted with signs in (x) Equipment necessary for the care, geographic land area identifiable by appropriate language, which shall cleaning, feeding, waste disposal, and geological, political or surveyed convey the following: Restricted handling of the ruminants must be boundaries that shares common Region—Keep Out, Quarantine Region— provided and maintained within the boundaries with, or is proximate to any Keep Out, or Registered Quarantine quarantine area. region of a different risk class, as Region—Keep Out. (xi) Additional requirements as to determined by the Administrator. (4) Feed. The animal feed supply in security, physical plant and facilities, Administrator. The Administrator of the PEQF must consist only of feed and sanitation may be imposed by the the Animal and Plant Health Inspection obtained from a region that is classified Administrator, in each specific case in Service or any other employee of the as Risk Class RN, R1, or R2 for foot-and- order to assure that the quarantine of the Animal and Plant Health Inspection mouth disease, and for any other exotic ruminants in a facility will be adequate Service, United States Department of disease necessitating the quarantine or to enable determination of their health Agriculture, delegated to act in the that could jeopardize the quarantine. status, prevent the spread of disease Administrator’s stead. (5) Other requirements. (i) Access into among ruminants in quarantine, and Affected animals. Animals currently the quarantine area must be through a prevent escape of animal disease agents infected or infested with, or exposed to, single door that must lead into a walk- from the facility. a communicable disease agent, or that through shower area with clothes are not known to be infected, infested, change areas located on either side of Subpart EÐSwine or exposed but that because of the shower and adjacent thereto. Sec. information, proximity, location, (ii) Toilet and lavatory facilities as 93.500 Definitions. season, or lack of surveillance data determined by the Administrator to be 93.501 General prohibitions; exceptions. could reasonably be expected to be adequate to preclude transmission of 93.502 Inspection of certain aircraft and infected, infested, or exposed to a other means of conveyance and shipping livestock or poultry disease agents from containers thereon; unloading, cleaning, communicable disease agent. the facility must be located within the and disinfection requirements. Affected premises or region. A ruminant holding areas. 93.503 Ports designated for the importation premises or region where a (iii) A sufficient supply of clean of swine. communicable disease agent is known clothing, including towels and footwear, 93.504 Import permits for swine specimens to exist; that is adjacent to or proximate as determined by the Administrator to for diagnostic purposes; and reservation to any known infected or infested be adequate to prevent the transmission fees for space at quarantine facilities premises or region so that airborne, of livestock or poultry disease agents maintained by APHIS. vector, or mechanical transmission of 93.505 Certificate of export and other from the facility, must be maintained requirements for swine. the disease agent could occur; or that, within the quarantine area. 93.506 Permit, certificate, declaration and because of lack of surveillance data, (iv) A continuous supply of hot and other documents for swine. could reasonably be expected to be cold running water, including potable 93.507 Inspection at the port of entry. infected, infested, or exposed to a water for personnel, must be provided. 93.508 Articles accompanying swine. communicable disease agent. 17066 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

Animal and Plant Health Inspection Driven. Moved (animals) from one (2) Semi-permanent identification: Service (APHIS). The Animal and Plant place to another by walking under their Identification such as metal or plastic Health Inspection Service of the United own power and being herded and ear tags that may remain on an animal States Department of Agriculture. guided by persons or trained animals. permanently but can be easily altered, Animals. All species of the animal Ectoparasites. Acarid (mites, ticks) or lost or removed. kingdom including: Cattle, sheep, goats, insect members of the Phylum (3) Non-permanent identification: other ruminants, swine, horses, asses, Arthropoda that spend all or part of Identification such as temporary ear mules, zebras, dogs, and poultry that are their life cycle on the exterior of avian, tags, chain tags, back tags, or tail tags. susceptible to communicable diseases of reptilian or mammalian hosts and that (4) Temporary identification: Lot livestock or capable of being carriers of are known or suspected to be the vectors identification if lots are not mixed, or those diseases or their arthropod of communicable disease agents, or are the origin of all lots in a mixed lot. vectors. the cause of disease or irritation in Immediate slaughter. Consignment APHIS representative. Any individual animals or birds. directly from the port of entry to a 1 employed by the Animal and Plant Equivalent test. A serologic, recognized slaughtering establishment Health Inspection Service, United States microbiologic, chemical, or physical test and slaughter thereat within two weeks Department of Agriculture, who is approved for use in a region exporting from the date of entry. Import (imported, importation) into authorized to perform the services livestock or livestock products to the the United States. To bring into the required by this part. United States and recognized by the territorial limits of the United States. Approved brucellosis test. Any test Administrator as providing results equal Inspector. An employee of the Animal recognized as an official brucellosis test to a test approved by the United States and Plant Health Inspection Service in the United States according to § 78.1 Department of Agriculture. Recognition authorized to perform duties required of this chapter, or a test recognized as of a test as an ‘‘equivalent test’’ will be under this subpart. an equivalent test by the Administrator made by the Administrator after he or Livestock. Domesticated species of and that is recognized as an official test she reviews scientific data that shows cattle, swine, sheep, goats, llamas, in a country exporting animals to the that the results of the test are equal to horses, or poultry that normally and United States. the USDA-approved test. historically have been kept and raised Approved pseudorabies test. Any test Exposed. (1) An animal or means of on farms. Livestock also includes bison recognized as an official pseudorabies conveyance that has been in contact and cervidae or other species kept in test in the United States according to with or that can reasonably be expected captivity for producing food or fiber, or § 85.1 of this chapter, or a test to have been in contact with an animal, for other commercial purposes. recognized as an equivalent test by the feed, water, air, soil, tools, or other Moved directly. Moved (shipped, Administrator and that is recognized as objects, insects, or ectoparasites infected transported, or otherwise moved) an official test in a country exporting to or contaminated with a communicable without unloading and without the United States. disease agent, as determined by the stopping except for refueling, or for Approved tests for restricted diseases Administrator. traffic conditions such as traffic lights or or agents. Diagnostic tests or procedures (2) A region or premises where an stop signs. that are determined by the animal, feed, water, air, soil, tools or Official seal. A serially numbered, Administrator to be scientifically valid other objects, insects, or ectoparasites metal or plastic strip, consisting of a to diagnose a restricted animal disease. contaminated with a communicable self-locking device on one end and a Authorized veterinarian. A disease agent are or have been present slot on the other end, which forms a veterinarian accredited, employed or within the known incubation period of loop when the ends are engaged and authorized by the National Veterinary the disease agent. which cannot be reused if opened, or a Services of the country to carry out the (i) Direct exposure: Exposure by serially numbered, self-locking button required inspection and certification coming into direct contact with an which can be used for this purpose. services. infected animal, or with feed, water, air, Operator. Any person operating an Border definitions. See § 92.1 of this soil, tools, or other objects, that have approved quarantine facility. chapter. been contaminated by discharges from Permitted treatment. A treatment Case. An individual animal affected an infected animal. authorized by the Administrator to be by a communicable disease agent. (ii) Indirect exposure: Exposure by used in the official treatment of animals Depending on the disease condition, coming into contact with vector insects for control or removal of ectoparasites. this may be an animal with clinical or ectoparasites, or objects that have Persons. Any individual, corporation, signs, or an animal with serological or been contaminated other than by company, association, firm, partnership, society, joint stock company, or other pathological evidence of infection, or an discharges from an infected animal. legal entity. infested animal. Herd. (1) A group of animals under Port Veterinarian. A veterinarian Cattle. Animals of the bovine species. common ownership or supervision that employed by APHIS to perform duties Communicable disease. Any are maintained and intermingle on one required under this part at a port of contagious or infectious disease of or more parts of a single premises (farm, entry. animals. It can be transmitted either ranch, feedlot, etc.); or Post-importation quarantines. directly or indirectly to a susceptible (2) A group of animals under common Quarantines applied in the importing animal from an infected animal, vector, ownership or supervision maintained region at a facility specially designated inanimate reservoir, or other source. on geographically separated premises as an import quarantine facility. Contagious disease. Any but that have been interchanged communicable disease transmitted from between the different premises or have 1 The name of recognized slaughtering one infected animal to another by direct been otherwise intermingled. establishments approved under this part may be contact or by feed, water, aerosol, or Identification. (1) Permanent obtained from the Area Veterinarian in Charge contaminated objects. (AVIC), Veterinary Services, Animal and Plant identification: Brands, tattoos, or Health Inspection Service, for the State of Department. The United States electronic identification that cannot be destination of the shipment. AVIC telephone Department of Agriculture (USDA). readily removed or altered. numbers can be found in the local telephone book. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17067

Pre-embarkation quarantines. Guam, the Northern Mariana Islands, (1)(i) The swine are maintained under Quarantines applied in the exporting Puerto Rico, the Virgin Islands of the continuous confinement in transit region. May be on the premises of United States, and all other Territories through the United States aboard an origin, a separate quarantine facility, a and Possessions of the United States. aircraft, ocean vessel, or other means of border station, or other facility used to Vector-borne disease. A disease conveyance; or hold animals while in transit. transmitted indirectly to an animal (ii) The swine are unloaded, in the Quarantine. Confinement of all through an intermediate arthropod course of such transit, into a swine susceptible animals, animal products, vector, including ticks or insects. holding facility that is provided by the feed, farm machinery, other equipment, Veterinarian in Charge. The carrier or its agent and that has been means of conveyance, and any other veterinary official of the Animal and approved in advance by the potentially contaminated objects to a Plant Health Inspection Service, United Administrator in accordance with premises or area where infection or States Department of Agriculture, who paragraph (c) of this section as adequate infestation with a specific restricted is assigned by the Administrator to to prevent the spread within the United agent has been found or is suspected to supervise and perform the official States of any livestock disease, and the exist. animal health work of the Animal and swine are maintained there under Recognized slaughtering Plant Health Inspection Service in the continuous confinement until loaded 2 establishment. An establishment where State or area concerned. aboard a means of conveyance for slaughtering operations are regularly Zoological park. A zoo, park, garden transportation from the United States carried on under Federal or State or other place, maintained under the and are maintained under continuous inspection and that has been approved surveillance of a licensed Doctor of confinement aboard such means of by APHIS to receive animals for Veterinary Medicine, for the exhibition conveyance until it leaves the United slaughter under this part. of live animals, pigeons or birds, for the States; the import permit will specify Region. Any defined geographic land purpose of public recreation or any additional conditions necessary to region identifiable by geological, education. assure that the transit of the swine political or surveyed boundaries. through the United States can be made Restricted agent. A livestock § 93.501 General prohibitions; exceptions. without endangering the livestock or communicable disease agent, vector, or (a) No swine subject to the provisions poultry of the United States, and that host of an agent not known to exist in of this part may be imported into the Department inspectors may inspect the the United States or that is subject to a United States except in accordance with swine on board such means of Federal or cooperative Federal/State the regulations in this part; 3 nor may conveyance or in such holding facility control or eradication program within any such swine be handled or moved as provided in section 5 of the Act of the United States. Restricted agents are after physical entry into the United July 2, 1962 (21 U.S.C. 134d) to listed in § 92.2 of this chapter. States before final release from ascertain whether the requirements of Risk Class regions. Exporting regions quarantine or any other form of this paragraph are met, and dispose of designated by the Administrator governmental detention except in them in accordance with section 2 of the according to the results of a risk compliance with such regulations; Act of July 2, 1962 (21 U.S.C. 134a) if assessment as defined in § 92.1 of this Provided That, except as prohibited by such conditions are not met; and chapter, and determined by criteria as section 306 of the Act of June 17, 1930, (2) The carrier or its agent executes set forth in § 92.3 of this chapter are as amended (19 U.S.C. 1306), the and furnishes to the collector of U.S. incorporated herein and are applicable Administrator may upon request in Customs at the first port of arrival a to this part. specific cases permit swine to be declaration stating that the swine will Ruminants. All animals that chew the brought into or through the United be retained aboard such means of cud, such as cattle, buffaloes, sheep, States under such conditions as he or conveyance or in an approved holding goats, deer, antelopes, camels, llamas she may prescribe, when he or she facility during transshipment as and giraffes. required by paragraphs (a)(1)(i) and Shipping container. For the purposes determines in the specific case that such (a)(1)(ii) of this section. of § 93.402, any container of a type action will not endanger the livestock or specially adapted for use in transporting poultry of the United States. (c) Provisions for the approval of any article on the means of conveyance (b) Except for swine prohibited entry facilities required in this paragraph are: involved. by section 306 of the Act of June 17, (1) They must be sufficiently isolated Susceptible animals. Species of 1930, as amended (19 U.S.C. 1306), the to prevent direct or indirect contact ruminants or other animals that can provisions in this part relating to swine with all other animals and birds while become infected with a specific disease shall not apply to healthy swine in in the United States; agent. transit through the United States, if they (2) They must be so constructed that Trail. Move animals from one place to are not known to be infected with or they provide adequate protection another by having them walk under exposed, within 60 days preceding the against environmental conditions and their own power, and by leading them date of export from the region of origin, can be adequately cleaned, washed and by ropes or other devices tied to the to communicable diseases of swine: disinfected; animal and guided by persons or trained and, if an import permit 4 has been (3) They must provide for disposal of animals. obtained under § 93.504 of this chapter swine carcasses, manure, bedding, Transported. Moved or shipped from and all conditions therein are observed; waste and any related shipping one place to another by any means of and if the following conditions are met: materials in a manner that will prevent conveyance, such as airplane, ship, dissemination of disease; boat, barge, truck, train, cart, or other 3 Importations of certain animals from various (4) They must have provisions for vehicle. countries are absolutely prohibited under part 94 adequate sources of feed and water and United States. All of the States of the because of specified diseases. for attendants for the care and feeding 4 Such permit may be obtained from the National of swine in the facility; United States, the District of Columbia, Center for Import and Export, Veterinary Services, APHIS, 4700 River Road Unit 39, Riverdale, MD (5) They must comply with additional 2 See footnote 1 in § 93.500. 20737–1231. requirements as may be imposed by the 17068 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

Administrator if deemed applicable for time and manner prescribed by, the the ports specified in this section. In a particular shipment; and inspector. special cases, other ports may be (6) They must also comply with all designated as quarantine stations under applicable local, State and Federal § 93.503 Ports designated for the this section by the Administrator, with importation of swine. requirements for environmental quality the concurrence of the Secretary of the and with the provisions of the Animal (a) Air and ocean ports. The following Treasury. Welfare Regulations in chapter I of this ports have APHIS inspection and title, as applicable. quarantine facilities necessary for § 93.504 Import permits for swine and for quarantine stations and all swine must swine specimens for diagnostic purposes; § 93.502 Inspection of certain aircraft and be entered into the United States only and reservation fees for space at quarantine other means of conveyance and shipping through these stations, except as facilities maintained by APHIS. containers thereon; unloading, cleaning, otherwise provided in this section: Los (a) Application for import permit; and disinfection requirements. Angeles, California; Miami, Florida; reservation required. (1) To import (a) Inspection. All aircraft and other Honolulu, Hawaii; and Newburgh, New swine and swine test specimens for means of conveyance (including York. diagnostic screening purposes from any shipping containers thereon) moving (b) Canadian border ports. The part of the world, the importer must first into the United States from any foreign following land border ports are apply for and obtain from APHIS an country are subject to inspection designated as having the necessary import permit. Swine imported through without a warrant by properly identified inspection facilities for the entry of land border ports from regions classified and designated APHIS inspectors to swine from Canada: Eastport, Idaho; as Risk Class RN for foot-and-mouth determine whether they are carrying any Houlton and Jackman, Maine; Detroit, disease, rinderpest, hog cholera, African animal, carcass, product or article Port Huron, and Sault Ste. Marie, swine fever, and swine vesicular disease regulated or subject to disposal under Michigan; Baudette, Minnesota; are exempt from import permit any law or regulation administered by Opheim, Raymond, and Sweetgrass, requirements. The application must the Secretary of Agriculture for Montana; Alexandria Bay, Buffalo, and specify the name and address of the prevention of the introduction or Champlain, New York; Dunseith, importer; the species, breed, number or dissemination of any communicable Pembina, and Portal, North Dakota; quantity of swine or swine test animal disease (21 U.S.C. 134d). Derby Line and Highgate Springs, specimens to be imported; the purpose (b) Unloading requirements. Vermont; Blaine, Lynden, Oroville, and of the importation; individual swine Whenever, in the course of any such Sumas, Washington. identification that includes a inspection at any port in the United (c) Mexican border ports. The description of the swine, name, age, States, the APHIS inspector has reason following land border ports are markings if any, registration number if to believe that the means of conveyance designated as having the necessary any, and tattoo or eartag; the region of or container is contaminated with inspection facilities for the entry of origin; the name and address of the material of animal (including poultry) swine from Mexico: Brownsville, exporter; the port of embarkation in the origin, such as, but not limited to, meat, Hidalgo, Laredo, Eagle Pass, Del Rio, foreign country; the mode of organs, glands, extracts, secretions, fat, Presidio, and El Paso, Texas; Douglas, transportation, route of travel, and the bones, blood, lymph, urine, or manure, Naco, Nogales, Sasabe, and San Luis, port of entry in the United States; the so as to present a danger of the spread Arizona; Calexico and San Ysidro, proposed date of arrival of the swine or of any communicable animal disease, California; and Antelope Wells, and swine test specimens to be imported; the inspector may require the unloading Columbus, New Mexico. and the name of the person to whom the of the means of conveyance and the (d) Special ports. Charlotte Amalie, swine or swine test specimens will be emptying of the container if he or she St. Thomas, and Christiansted, St. Croix, delivered and the location of the place deems it necessary to enable him or her in the United States Virgin Islands, are in the United States to which delivery to determine whether the means of hereby designated as quarantine stations will be made from the port of entry. conveyance or container is in fact so for the entry of swine from the British Additional information may be required contaminated. The principal operator of Virgin Islands into the United States in the form of certificates concerning the means of conveyance and his or her Virgin Islands for immediate slaughter. specific disease agents to which the agent in charge of the means of (e) Limited ports. The following ports swine are susceptible, as well as conveyance must comply with any such are designated as having inspection vaccinations or other precautionary requirement under the immediate facilities for the entry of swine and treatments to which the swine or swine supervision of, and in the time and swine products such as swine test test specimens have been subjected. manner prescribed by, the inspector. specimens that do not appear to require Notice of any such requirements will be 5 (c) Cleaning and disinfection. restraint and holding inspection given to the applicant in each case. (2) An application for permit to Whenever, upon inspection under this facilities: Anchorage and Fairbanks, import swine and/or swine test section, an inspector determines that a Alaska; San Diego, California; specimens may be denied because of: means of conveyance or shipping Jacksonville, St. Petersburg-Clearwater, Communicable disease conditions in the container is contaminated with material and Tampa, Florida; Atlanta, Georgia; region of origin, or in a region where the of animal origin so as to present a Chicago, Illinois; New Orleans, shipment has been or will be held or danger of the spread of any Louisiana; Portland, Maine; Baltimore, through which the shipment has been or communicable animal disease, he or she Maryland; Boston, Massachusetts; will be transported; deficiencies in the shall notify the principal operator of the Minneapolis, Minnesota; Great Falls, regulatory programs for the control or means of conveyance or his or her agent Montana; Portland, Oregon; San Juan, eradication of animal diseases and the in charge, of such determination and the Puerto Rico; Galveston and Houston, unavailability of veterinary services in requirements under this section. The Texas; and Seattle, Spokane, and the above mentioned regions; the person so notified must cause the Tacoma, Washington. cleaning and disinfection of such means (f) Designation of other ports. The 5 5 See §§ 93.505, 93.506, and 93.515 for of conveyance and container under the Secretary of the Treasury has approved additional requirements for the importation of immediate supervision of, and in the the designation as quarantine stations of swine. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17069 importer’s failure to provide satisfactory made: Except that a reservation fee shall the specified U.S. port of entry for evidence concerning the origin, history, not be forfeited if: presentation to the collector of customs. and health status of the swine; the lack (A) Written notice of cancellation All swine and all swine test specimens of satisfactory information necessary to from the importer or the importer’s for diagnostic screening purposes for determine that the importation will not agent is received by the office of the which an import permit has been issued be likely to transmit any communicable veterinarian in charge of the quarantine for importation into the United States disease to livestock or poultry of the facility 6 during regular business hours will be received at the specified port of United States; or any other (8:00 a.m. to 4:30 p.m. Monday through entry within the time prescribed in the circumstances that the Administrator Friday, excluding holidays) no later import permit. That time shall not believes require such denial to prevent than 15 days prior to the beginning of exceed 14 days from the first day that the dissemination of any communicable the time of importation of the swine as the permit is effective for all permits disease of livestock or poultry into the specified in the import permit or as relevant to the shipment or shipments. United States. arranged with the veterinarian in charge All swine and swine test specimens for (3)(i) The importer or importer’s agent of the quarantine facility if no import which an import permit is required by must pay or ensure payment of a permit is required (the 15 day period this subpart will not be eligible for entry reservation fee for each lot of swine to shall not include Saturdays, Sundays, or into the United States if an import be quarantined in a facility maintained holidays); or permit has not been issued; if the swine by USDA. For swine, the reservation fee (B) The Administrator determines that or swine test specimens are shall be 100 percent of the cost of services, other than provided by unaccompanied by such an import providing care, feed, and handling carriers, necessary for the importation of permit; if shipment is from any port during quarantine, as estimated by the the swine within the requested period other than the one designated in the quarantine facility’s veterinarian in are unavailable because of unforeseen import permit; if arrival in the United charge. circumstances as determined by the States is at any port other than the one (ii) At the time the importer or the Administrator (such as the closing of an designated in the import permit; if the importer’s agent requests a reservation airport due to inclement weather or the swine or swine test specimens imported of quarantine space, the importer or unavailability of the reserved space due are different from those described in the importer’s agent must pay the to the extension of another quarantine). import permit; if the swine or swine test (v) If the reservation fee was ensured reservation fee by check or U.S. money specimens are not handled as outlined by a letter of credit and the fee is to be order or ensure payment of the in the application for the import permit forfeited under paragraph (a)(3)(iv) of reservation fee by an irrevocable letter and as specified in the permit issued; or this section, the Department will draw of credit from a commercial bank (the if ruminants or swine other than those against the letter of credit unless the effective date on such letter of credit covered by the import permits are must run to 30 days after the date the reservation fee is otherwise paid at least aboard the transporting carrier. swine are scheduled to be released from 3 days prior to the expiration date of the quarantine); except that anyone who letter of credit. § 93.505 Certificate of export and other issues a check to the Department for a (vi) When a reservation is canceled in requirements for swine. reservation fee that is returned because accordance with paragraph (a)(3)(iv)(A) (a) All swine imported or offered for of insufficient funds shall be denied any of this section and the provisions of importation from any part of the world, further request for reservation of a paragraph (a)(3)(iv)(B) of this section do except for swine that are imported for quarantine space until the outstanding not apply, a $40.00 cancellation fee immediate slaughter from regions that amount is paid. shall be charged. If a reservation fee was are classified as Risk Class RN for all (iii) Any reservation fee paid by check paid, the cancellation fee shall be restricted agent(s) of swine, and except or U.S. money order shall be applied deducted from any reservation fee as provided in paragraphs (c) and (d) of against the expenses incurred for returned to the importer or the this section,7 must be accompanied by services received by the importer or importer’s agent. If the reservation fee a certificate of export signed by an importer’s agent in connection with the was ensured by a letter of credit, the authorized veterinarian and endorsed by quarantine for which the reservation Department will draw the amount of the the National Veterinary Services of the was made. Any part of the reservation cancellation fee against the letter of country of export who certifies that the fee that remains unused after being credit unless the cancellation fee is veterinarian signing and issuing the applied against the expenses incurred otherwise paid at least 3 days prior to certificate is authorized to do so and for services received by the importer or the expiration date of the letter of credit. who certifies that: the importer’s agent in connection with (b) Import Permit. When an import (1) The swine originate from premises the quarantine for which the reservation permit is issued, the original and two that are not known to have been affected was made, shall be returned to the copies will be sent to the importer. It with any communicable diseases of individual who paid the reservation fee. shall be the responsibility of the swine during the previous 60 days; If the reservation fee is ensured by a importer to forward the original permit (2) The swine originate from premises letter of credit, the Department will and one copy to the shipper in the that are not known to have been affected draw against the letter of credit unless country of origin, and it shall also be the with restricted ectoparasites of swine payment for services received by the responsibility of the importer to ensure during the last previous days; importer or importer’s agent in that the shipper presents the copy of the (3) During transportation to the port of connection with the quarantine is import permit to the carrier and makes embarkation there was no direct or otherwise made at least 3 days prior to proper arrangements for the original indirect exposure to any potential the expiration date of the letter of credit. permit to accompany the shipment to carrier animals from any region affected (iv) Any reservation fee shall be with restricted agents that affect swine; forfeited if the importer or the 6 The addresses of USDA quarantine facilities (4) While en route to the port of entry, importer’s agent fails to present for may be found in telephone directories listing the facilities or by contacting the National Center for the swine were not trailed or driven entry, within 24 hours following the Import and Export, Veterinary Services, APHIS, designated time of arrival, the lot of 4700 River Road Unit 39, Riverdale, MD 20737– 7 See § 93.515 for additional requirements for swine for which the reservation was 1231. swine imported from specific risk class regions. 17070 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules through any Risk Class R3, R4 or RU have been exposed to a communicable may be landed from any conveyance region for any tick-borne restricted disease, they shall be refused entry and except under such restrictions as the agents; and shall be handled thereafter in inspector in charge at the port of entry (5) While en route to the port of entry, accordance with the provisions of shall direct. the swine were not trailed, driven, section 8 of the Act of August 30, 1890 transported, or otherwise moved § 93.509 Movement from conveyances to (26 Stat. 416; 21 U.S.C. 103), or quarantine station. through any Risk Class R3, R4 or RU quarantined, or otherwise disposed of as region for any restricted insect- the Administrator may direct. Platforms and chutes used for transmitted agents during a time of year handling imported swine must be when the insect vectors were active; § 93.506 Permit, certificate, declaration cleaned and disinfected under APHIS (6) The swine were inspected on the and other documents for swine. supervision after being so used. The day of embarkation and found to be free (a) The export certificates, import said swine must not be moved over any of restricted ectoparasites as listed in permits, declarations, and affidavits highways nor allowed to come in § 92.2 of this chapter, or were treated required by the regulations in this part contact with other swine, but must be with one of the permitted treatments in must be presented by the importer or his transferred from the conveyance to the § 72.13(b) of this chapter within 10 to 14 or her agent to the collector of customs quarantine grounds only in boats, cars, days of embarkation. If treated, the at the port of entry, upon arrival of the or other vehicles approved by the pesticide, active ingredient, swine at such port, for the use of the inspector in charge at the port of entry. concentration, and date applied must be veterinary inspector at the port of entry. Such cars, boats, or vehicles must be recorded on the certificate of export; (b) For all swine imported or offered cleaned and disinfected under APHIS and for importation, the importer or his or supervision immediately after such use, (7) The swine were transported to the her agent must first present two copies by the carrier moving the same. The United States only in means of of a declaration that lists the port of railway cars so used must be either cars conveyance or vehicles that were entry, the name and address of the reserved for this exclusive use or box cleaned and disinfected prior to use. importer, the name and address of the cars not otherwise employed in the (b) Prior to entry into the United broker, the origin of the swine, the transportation of animals or their fresh States, the swine must be identified in number, breed, species, and purpose of products. When movement of the accordance with § 71.19 of this chapter. the importation, the name of the person aforesaid swine upon or across a public (c) Swine that are from a region to whom the swine will be delivered, highway is unavoidable, it shall under classified as RN for all restricted and the street address of the place to such careful supervision and diseases of swine and that are to be which such delivery will be made. restrictions as the inspector in charge at transported in-bond through the United the port of entry may direct. States for immediate export, shall be § 93.507 Inspection at the port of entry. inspected at the border port of entry Inspection shall be made at the port § 93.510 Swine quarantine facilities. and, when accompanied by an import of entry of all swine imported from any (a) Privately operated quarantine permit obtained under § 93.504 and part of the world. All swine found to be facilities. The importer, or his or her when all conditions therein are free from communicable disease and not agent, of swine subject to quarantine observed, shall be allowed entry into the to have been exposed thereto within 60 under the regulations in this part must United States and shall be otherwise days prior to their exportation to the arrange for acceptable transportation to handled in accordance with § 93.501(b). United States shall be admitted subject the privately operated quarantine (d) Swine originating in the United to the other provisions in this part; all facility and for the care, feed, and States and transported directly through other swine shall be refused entry. handling of the swine from the time of a region classified as RN for all Swine refused entry, unless exported unloading at the quarantine port to the restricted diseases of swine, may reenter within a time fixed in each case by the time of release from quarantine. Such the United States without foreign health Administrator, and in accordance with arrangements shall be agreed to in or test certificates when accompanied other provisions he or she may require advance by the Administrator. All by copies of the United States export in each case for their handling, shall be expenses resulting therefrom or incident health certificates properly issued and disposed of as the Administrator may thereto shall be the responsibility of the endorsed in accordance with the direct, in accordance with provisions of importer; APHIS assumes no regulations in part 91 of this chapter: section 2 of the Act of July 2, 1962 (21 responsibility with respect thereto. The Provided, That, to qualify for reentry U.S.C. 134a), or the provisions of quarantine facility must be suitable for into the United States, the date, time, section 8 of the Act of August 30, 1890 the quarantine of such swine and must port of entry, and signature of the port (21 U.S.C. 103). Such portions of the be approved by the Administrator prior veterinarian of the foreign country that transporting vessel, and of its cargo, that to the issuance of any import permit. inspected the swine for entry into the have been exposed to any such swine or The facilities occupied by swine must foreign country shall be recorded on the their emanations, must be disinfected in be kept clean and sanitary. If for any United States health certificate, or a such manner as may be considered cause the care, feed, or handling of paper containing such information shall necessary by the inspector in charge at swine, or the sanitation of the facilities, be attached to the certificate that the port of entry, to prevent the is neglected, in the opinion of the accompanies the swine. In all cases, it introduction or spread of livestock or inspector assigned to supervise the shall be determined by the veterinary poultry disease, before the cargo is quarantine, such services may be inspector at the United States port of allowed to land. furnished by APHIS in the same manner entry that the swine are the identical as though arrangements had been made swine covered by said certificate. § 93.508 Articles accompanying swine. for such services as provided by (e) If the swine are unaccompanied by No litter or manure, fodder or other paragraph (b) of this section, and/or the the certificate of export as required by aliment, nor any equipment such as swine may be disposed of as the paragraph (a) of this section, or if such boxes, buckets, ropes, chains, blankets, Administrator may direct, including swine are found upon inspection at the or other things used for or about swine sale in accordance with the procedure port of entry to be affected with or to governed by the regulations in this part, described in paragraph (b) of this Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17071 section. The importer, or his or her Administrator. When payment is not removed from the quarantine premises agent, must request in writing such made and the swine are to be sold to except in compliance with all State and inspection and other services as may be recover payment for services received, local regulations. required, and shall waive all claim the importer, or his or her agent, will be against the United States and APHIS or notified by the inspector that if said § 93.513 Manure from quarantined swine. any employee of APHIS for damages charges are not immediately paid or No manure may be removed from the that may arise from such services. The satisfactory arrangements made for quarantine premises until the release of Administrator may prescribe reasonable payment, the swine will be sold at the swine producing the manure. rates for the services provided under public sale to pay the expense of care, § 93.514 Appearance of disease among this paragraph. When it is found feed, and handling during that period. swine in quarantine. necessary to extend the usual minimum The sale will be held after the expiration (a) If any restricted agent or other quarantine period, the importer, or his of the quarantine period, at such time communicable disease appears among or her agent, shall be so advised in and place as may be designated by the swine during the pre-embarkation or writing and must pay for such General Services Administration of the post-importation quarantine period, additional quarantine and other services Federal Government or other designated special precautions shall be taken to required. Payment for all services selling agent. The proceeds of the sale, prevent spread of the infection to other received by the importer, or his or her after deducting the charges for care, animals in the quarantine station or to agent, in connection with each separate feed, and handling of the swine and those outside the grounds. Affected lot of swine must be made by certified other expenses, including the expense swine in post-importation quarantine check or U.S. money order prior to of the sale, shall be held in a Special shall be disposed of as the release of the swine. If such payment is Deposit Account in the United States Administrator may direct, depending not made, the swine may be sold in Treasury for 6 months from the date of upon the nature of the disease. accordance with the procedure sale. If not claimed by the importer, or (b) During the post-importation described in paragraph (b) of this his or her agent, within 6 months from quarantine period, the Administrator section, or otherwise disposed of as the date of sale, the amount so held may require additional testing of the test directed by the Administrator. shall be transferred from the Special positive animal(s) and/or test negative (b) Quarantine facilities maintained Deposit Account to the General Fund animals to determine if the animals will by APHIS. The importer, or his or her Account in the United States Treasury. be eligible for importation into the agent, of swine subject to quarantine (c) Amounts collected from the United States. under the regulations in this part must importer, or his or her agent, for service rendered shall be deposited so as to be § 93.515 Requirements for importation of arrange for acceptable transportation to live swine from various risk class regions. the quarantine facility, and for the care, available for defraying the expenses involved in this service. Swine may be imported from any feed, and handling of the swine from the regions of the world only if they meet time they arrive at the quarantine § 93.511 Quarantine stations, visiting the requirements of this section, and all facility, and for the care, feed, and restricted; sales prohibited. other applicable requirements of this handling of the swine from the time Visitors shall not be admitted to the part.8 they arrive at the quarantine port to the quarantine enclosure during any time (a) Regions classified as Risk Class RN time of release from quarantine. Such that swine are in quarantine, except that for all restricted agents affecting swine. arrangements shall be agreed to in an importer (or his or her accredited In addition to the export certificate advance by the Administrator. The agent or veterinarian) may be admitted requirements of § 93.505, the certificate importer or his or her agent must to the yards and buildings containing of export for live swine from regions request in writing such inspection and his or her quarantined swine at such that are classified as Risk Class RN for other services as may be required, and intervals as may be deemed necessary, all restricted agents of swine must shall waive all claim against the United and under such reasonable conditions certify that the swine to be imported States and APHIS or any employee of and restrictions as may be imposed, by have only been on premises located in APHIS, for damages that may arise from the inspector in charge of the quarantine regions classified as Risk Class RN for such services. All expenses resulting station. On the last day of the the specific restricted agent, and that therefrom or incident thereto shall be quarantine period, owners, officers or they meet all other requirements of this the responsibility of the importer; registry societies, and others having part. APHIS assumes no responsibility with official business or whose services may (b) B. suis. Swine imported for respect thereto. The Administrator may be necessary in the removal of the swine immediate slaughter from regions prescribe reasonable rates for the may be admitted upon written classified as Risk Class R1 or R2 for B. services provided under this paragraph. permission from the said inspector. No Suis, or from regions classified as R3 if When it is found necessary to extend exhibition or sale shall be allowed from herds that would meet the criteria the usual minimum quarantine period, within the quarantine grounds. for validated brucellosis-free herds the importer, or his or her agent, shall under § 78.1 of this chapter, are exempt be so advised in writing and shall pay § 93.512 Milk from quarantined swine. from B. suis testing and quarantine for such additional quarantine and other Milk or cream from swine requirements. Such swine must be services required. Payment for services quarantined under the provisions of this consigned from the port of entry to a received by the importer, or his or her part may not be used by any person recognized slaughtering establishment agent, in connection with each separate other than those in charge of such and there be slaughtered within 2 weeks lot of swine must be made by certified swine, nor be fed to any animals other from the date of entry. Such swine must check or U.S. money order prior to than those within the same enclosure, be moved from the port of entry in release of the swine. If such payment is without permission of the inspector in conveyances sealed with seals of the not made, the swine may be sold in charge of the quarantine station and United States Government, applied and accordance with the procedure subject to such restrictions as he or she removed by an APHIS representative, or described in this paragraph, or may consider necessary to each otherwise disposed of as directed by the instance. No milk or cream may be 8 8 See §§ 93.504, 03.505, and 93.506. 17072 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules an individual authorized for this plan, the animals may be imported regions that are classified as Risk Class purpose by an APHIS representative. under paragraph (b)(2) of this section. R3, or for live swine from any herd in (1) Regions classified as Risk Class R1 (c) Pseudorabies virus. Swine regions classified as risk class R4, or RU for B. suis. In addition to the export imported for immediate slaughter from for pseudorabies virus, must certify that certificate requirements of § 93.505, the any region of the world are exempt from the swine to be imported: certificate of export for live non- pseudorabies virus testing and (A) Have not been vaccinated with neutered swine over 6 months of age quarantine requirements. Such swine any pseudorabies vaccine, other than an from regions that are classified as Risk must be consigned from the port of approved gene-altered vaccine as listed Class R1 for B. suis must certify that the entry to a recognized slaughtering in part 85 of this chapter. If the swine swine to be imported: establishment and there be slaughtered are vaccinated, the date of vaccination (i) Were born and resided only in within 2 weeks from the date of entry. and the type of vaccine used must be regions classified as Risk Class RN or R1 Such swine must be moved from the recorded on the certificate of export; for B. suis; and port of entry in conveyances closed with (B) Have had a negative result to an (ii) Have not been vaccinated with official seals of the United States approved test for pseudorabies within any live brucella vaccine. Government applied and removed by an 30 days before exportation; and (2) Regions classified as Risk Class R2 APHIS representative, or an individual (C) Have undergone a 30-day pre- or (for swine from validated swine authorized for this purpose by an APHIS embarkation quarantine. brucellosis-free herds) regions classified representative. (ii) The swine must undergo a 15-day as Risk Class R3 for B. suis. (1) Regions classified as Risk Class R1 minimum post-importation quarantine (i) In addition to the export certificate for pseudorabies virus. In addition to in a facility designated and approved by requirements of § 93.505, the certificate the export certificate requirements of the Administrator. of export for live non-neutered swine § 93.505, the certificate of export for live (iii) During the post-importation over 6 months of age from regions that swine from regions that are classified as quarantine, the swine must be tested are classified as Risk Class R2, or from Risk Class R1 for pseudorabies virus with negative results using an approved regions classified as R3 for B. suis if must certify that the swine to be test. This test must be administered a from a validated brucellosis-free herd,9 imported: minimum of 30 days after the test must certify that the swine to be (i) Were born and resided only in administered in the region of origin. imported: regions classified as Risk Class RN or R1 (d) Restricted ectoparasites—(1) (A) Were born and resided only in for pseudorabies virus; and Regions classified as Risk Class R1 and regions classified as Risk Class RN, R1, (ii) Have not been vaccinated with R2 for restricted ectoparasites. (i) In or R2, or (if the swine are from validated any pseudorabies vaccine. addition to the export certificate brucellosis-free herds in Risk Class R3 (2) Regions classified as Risk Class R2 requirements of § 93.505, the certificate regions) regions that are classified as and (if swine are from qualified of export for live swine from regions Risk Class R3 for B. suis; pseudorabies-negative herds) regions that are classified as Risk Class R1 or R2 (B) Have not been vaccinated with classified as Risk Class R3 for for restricted ectoparasites must certify any live brucellosis vaccine; and pseudorabies virus. In addition to the that the swine to be imported resided (C) Had a negative result to an export certificate requirements of for the previous 60 days only in regions approved test for brucellosis no less § 93.505, the certificate of export for live classified as Risk Class RN, R1, or R2 for than 30 days nor more than 60 days swine from regions classified as Risk restricted ectoparasites. prior to export; and Class R2, and for live swine from (ii) All imported swine will be (ii) The swine must be detained at the qualified pseudorabies-negative herds 10 inspected at the port of entry for any port of entry or animal import center from regions classified as R3 for ectoparasites, and given a precautionary until tested with negative results under pseudorabies virus, must certify that the treatment. If found to be infested with the supervision of the port veterinarian swine to be imported: any ectoparasites, the swine will be for B. suis with negative results. (i) Were born and resided only in refused entry until treated with one of (3) Regions classified as Risk Class R3 regions classified as Risk Class RN, R1 the permitted treatments listed in (if the swine are not from validated-free or R2 for pseudorabies virus, or (if the § 72.13(b) of this chapter, and retreated swine brucellosis herds), R4, and RU for swine are from qualified pseudorabies- 10 to 14 days after the initial treatment. B. suis. Herds in regions classified as negative herds in Risk Class R3 regions) (2) Regions classified as Risk Class Risk Class R3 for B. suis that do not regions that are classified as Risk Class R3, R4, or RU for restricted meet the criteria set forth in § 78.1 of R3; ectoparasites. (i) In addition to the this chapter for a brucellosis validated- (ii) Have not been vaccinated with export certificate requirements of free herd, and herds from regions any live pseudorabies vaccine; and § 93.505, the certificate of export for live classified as Risk Class R4 or RU must (iii) Have had a negative result to an swine from regions classified as Risk undergo a pre-embarkation complete approved test for pseudorabies within Class R3, R4 or RU for restricted herd test of all test eligible animals. If 30 days prior to the date of exportation. ectoparasites must certify that the swine no test-positive animals are found the (3) Regions classified as Risk Class R3 to be imported: animals may then be imported (for herds that do not qualify as (A) Were treated for ectoparasites according to the requirements in pseudorabies-negative herds), R4 or RU with an approved treatment 10 to 14 paragraph (b)(2) of this section. If test- for pseudorabies virus. days prior to export. If quarantine in a positive animals are found, the animals (i) In addition to the export certificate pre-embarkation facility is required, the are not eligible for export until the herd requirements of § 93.505, the certificate swine were treated immediately prior to has completed a herd cleanup plan as of export for live swine over 6 months entering a pre-embarkation facility; and stated in part 78 of this chapter. After of age from herds that do not qualify as (B) Were inspected while at the pre- the herd has completed a herd cleanup pseudorabies-negative herds, from embarkation facility and found to be free of any ectoparasites. 9 To be considered as validated brucellosis-free, a 10 To be considered as qualified pseudorabies- (ii) The imported swine will be herd must meet the standards set forth in § 78.1 of negative, a herd must meet the standards set forth inspected at the port of entry for any this chapter. in § 85.1 of this chapter. ectoparasites, and given a precautionary Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17073 treatment. If found to be infested with (ii) The imported swine must be SVD during the 12 months prior to any ectoparasites, the swine will be quarantined for at least 15 days at a export; refused entry until treated with one of post-importation quarantine facility (C) Have not been on a premises the permitted treatments listed in designated and approved by the located with 25 miles (40 km) of any § 72.13(b) of this chapter, then retreated Administrator. premises affected with FMD, RP, ASF, 10 to 14 days after the initial treatment. (iii) The swine must have a negative HC, or SVD in the 90 days prior to (e) Foot and mouth disease (FMD), result to an approved serological test for export; rinderpest (RP), African swine fever FMD, RP, ASF, HC, and/or SVD during (D) Have undergone pre-embarkation (ASF), hog cholera (classical swine the post-importation quarantine period. quarantine, for at least 60 days, from all fever) (HC), and swine vesicular disease (3) Regions classified as Risk Class R3 animals not part of the group to be (SVD). Swine imported for immediate for FMD, RP, ASF, HC, and/or SVD. imported, under USDA supervision in a slaughter that are born and raised in (i) In addition to the export certificate facility approved by APHIS under regions classified as Risk Class R1 or R2 requirements of § 93.505, the certificate § 93.517; and for FMD, RP, ASF, HC and/or SVD are of export for live swine from regions (E) During pre-embarkation exempt from the test and quarantine classified as Risk Class R3 for FMD, RP, quarantine, have negative results to two requirements in this paragraph. The HC, and/or SVD must certify that the tests conducted no sooner than 15 days swine must be consigned from the port swine to be imported: apart for FMD, RP, ASF, HC, and/or of entry to a recognized slaughtering (A) Were born and resided only in SVD, using an approved serological test. establishment and there slaughtered regions classified as Risk Class RN, R1, If indicated, oesophageal-pharyngeal within 2 weeks from the date of entry. R2 or R3 for FMD, RP, ASF, HC, and/ fluid samples will be taken for further The swine must be moved from the port or SVD; testing. of entry in conveyances closed with (B) Have not been vaccinated for (ii) The imported swine must be official seals of the United States FMD, RP, ASF, HC, or SVD; quarantined with sentinel animals at Government applied and removed by an (C) Have not been on any premises HSTAIC for at least 90 days, during APHIS representative, or an individual affected with FMD, RP, ASF, HC, or which time the swine must be re-tested for FMD, RP, ASF, HC, and/or SVD at authorized for this purpose by an APHIS SVD virus during the 12 months prior least twice with negative results using representative. to export; (1) Regions classified as R1 for FMD, (D) Have not been on any premises an approved serological test. If RP, ASF, HC, and/or SVD. In addition located within 25 miles (40 km) of any indicated, oesophageal-pharyngeal fluid to the export certificate requirements of premises affected with R3 for FMD, RP, samples will be taken for further testing. (5) Wild swine from any Risk Class § 93.505, the certificate of export for live ASF, HC, and/or SVD virus in the 90 R3, R4, or RU regions for foot-and- swine from regions classified as Risk days prior to export; mouth disease, rinderpest, hog cholera, Class R1 for FMD, RP, ASF, HC, and/or (E) for at least 60 days prior to export, swine vesicular disease, or African SVD must certify that the swine to be have undergone pre-embarkation swine fever. (i) Wild swine originating imported: quarantine from all animals not part of in the regions that are classified as Risk (i) Were born and resided only in the group to be imported, under USDA Class R3, R4, or RU for foot-and-mouth regions classified as Risk Class RN or R1 supervision in a facility approved by the disease, hog cholera, rinderpest, African for FMD, RP, ASF, HC, and SVD; USDA according to § 93.517; and (ii) Have not been vaccinated for (F) During pre-embarkation swine fever, and/or swine vesicular FMD, RP, ASF, HC, and/or SVD; and quarantine, have had negative results to disease may be carriers of such (iii) Have had a negative result to an two tests conducted no sooner than 15 restricted agents, even though the swine approved serological test for FMD, RP, days apart, for R3 for FMD, RP, ASF, do not show clinical evidence of the ASF, HC, and/or SVD within 30 days HC, and/or SVD, using an approved diseases. In view of these circumstances prior to exportation. serological test. If indicated, and in order to prevent the introduction (2) Regions classified as Risk Class R2 oesophageal-pharyngeal fluid samples and dissemination of communicable for FMD, RP, ASF, HC, and/or SVD. will be taken for further testing. diseases affecting livestock and protect (i) In addition to the export certificate (ii) The imported swine must be the livestock of the United States, requirements of § 93.505, the certificate quarantined at the Harry S Truman import permits for the importation of of export for live swine from regions Animal Import Center for at least 60 wild swine will be issued only if such classified as Risk Class R2 for FMD, RP, days without sentinel animals, during swine are intended for exhibition ASF, HC, and/or SVD must certify that which time the swine must be re-tested purposes in a zoological park previously the swine to be imported: at least once with negative results for approved by the Administrator, in (A) Were born and resided only in FMD, RP, ASF, HC, and/or SVD, using accordance with the standards specified regions classified as Risk Class RN, R1 an approved serological test. If in paragraph (e)(5)(ii) of this section, or R2 for FMD, RP, ASF, HC, and/or indicated, oesophageal-pharyngeal fluid and if the operator of such approved SVD; samples will be taken for further testing. zoological park and the importer, if such (B) Have not been vaccinated for (4) Regions classified as R4 or RU for operator and importer are different FMD, RP, ASF, HC, or SVD; FMD, RP, ASF, HC, and/or SVD. parties, has or have entered into the (C) Have undergone a 30-day pre- (i) In addition to the export certificate agreement set forth in paragraph embarkation quarantine. For swine from requirements of § 93.505, the certificate (e)(5)(iv) of this section with APHIS for regions classified as R2 for African of export for live swine from regions the maintenance and handling of such swine fever, the pre-embarkation that are classified as Risk Class R4 or RU wild swine in the manner specified in quarantine must be conducted in a for FMD, RP, ASF, HC, and/or SVD the agreement to prevent the vector-proof facility approved by the must certify that the swine to be introduction and dissemination of Administrator; and imported: communicable disease. The New York (D) Have had a negative result to an (A) Have not been vaccinated for port of entry is the only port at which approved serological test for FMD, RP, FMD, RP, ASF, HC, and/or SVD; facilities are available that are adequate ASF, HC, and/or SVD within 30 days (B) Have not been on any premises for the quarantining of wild swine. prior to exportation. affected with FMD, RP, ASF, HC, or Accordingly, permits issued for the 17074 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules importation of such wild swine will consigned, and the importer of the wild (Signature of importer) Subscribed and sworn require that the swine be imported swine, if such operator and importer are to before me this ll day of lllll, 19 ll. through the port of New York and be different parties, must execute an lllllllllllllllllllll quarantined at that port. The agreement covering wild each swine or (Title or designation) Administrator may cancel such a permit group of wild swine for which the lllllllllllllllllllll when he or she finds that any provision import permit is requested. The (Name of zoological park) By llllll (Signature of officer of zoological park) of this section or any other provision of agreement shall be in the following lllllllllllllllllllll the regulations has not been or is not form: (Title of officer) Subscribed and sworn to being complied with. Agreement for the Importation, Quarantine before me this ll day of llllll, 19 (ii) Approval of a zoological park for and Exhibition of Certain Wild Ruminants ll. the receipt and maintenance of and Wild Swine lllllllllllllllllllll imported wild swine as described in llllll, operator(s) of the zoological (Title or designation) this paragraph (e)(5)(ii) shall be on the park known as llllll (Name) located (f) Japanese encephalitis virus (JEV) llllll basis of an inspection, by an authorized at (City and state), and and Getah virus—(1) Regions classified llllll (Importer) hereby request a representative of the Department, of the llllll as Risk Class R1 for JEV and/or Getah physical facilities of the establishment permit for the importation of virus. In addition to the export (Number and kinds of animals) for exhibition and its methods of operation. Standards purposes at the said zoological park, said certificate requirements of § 93.505, the for acceptable physical facilities shall animals originating in a Risk Class R3, R4, or certificate of export for live swine from include satisfactory pens, cages, or RU region for rinderpest or foot-and-mouth regions classified as Risk Class R1 for enclosures in which the swine can be disease, and being subject to restrictions JEV and/or Getah virus must certify that maintained so as not to be in contact under regulations contained in part 93, title the swine to be imported: with the general public and free from 9, Code of Federal Regulations. (i) Have resided for at least 60 days contact with domestic livestock; natural In making this request, it is understood and immediately prior to export only on or established drainage from the agreed that: premises located in regions classified as zoological park that will avoid 1. The animals for which an import permit Risk Class RN or R1 for JEV and/or contamination of land areas where is requested will be held in isolation at a port Getah virus; domestic livestock are kept or with of embarkation in the region of origin, (ii) Have not been vaccinated for JEV which domestic livestock may approved by the Administrator as a port or Getah virus; and otherwise come in contact; provision for having facilities that are adequate for (iii) Have had a negative result to an maintaining wild animals in isolation from approved serological test for Japanese the disposition of manure, other wastes, all other animals and having veterinary and dead swine within the zoological supervision by officials of the country of encephalitis and/or Getah within 30 park; and other reasonable facilities origin of the animals. Such animals will be days prior to export. considered necessary to prevent the held in such isolation for not less than 60 (2) Regions classified as Risk Class R2 dissemination of disease agents from the days under the supervision of the veterinary for JEV and/or Getah virus. (i) In zoological park. The operator of the service of the country in which the region of addition to the export certificate zoological park must have available the origin is located to determine whether the requirements of § 93.505, the certificate services of a full-time or part-time animals show any clinical evidence of of export for live swine from regions veterinarian, or a veterinarian on a restricted agents or other communicable that are classified as Risk Class R2 for retainer basis, who must make periodic disease and to assure that the animals will JEV and/or Getah virus must certify that examinations of all swine maintained at not have been exposed to such a disease the swine to be imported: the zoological park for evidence of within the 60 days prior to their exportation (A) Have resided for at least 60 days disease; who must make a post-mortem from that region. immediately prior to their pre- 2. Shipment will be made directly from examination of each animal that dies; such port of embarkation to the port of New embarkation quarantine only on and who must make a prompt report of York as the port of entry into the United premises located in regions classified as suspected cases of contagious or States. If shipment is made by ocean vessel, Risk Class RN, R1, or R2 for JEV and/ communicable disease agents to the animals will not be unloaded in any or Getah virus; appropriate State or Federal livestock foreign port en route. If shipment is made by (B) Have not been vaccinated for JEV sanitary officials. air, the animals will not be unloaded at any or Getah virus; (iii) Manure and other animal wastes port or other place of landing except at a port (C) Have undergone a 30 day pre- must be disposed of within the approved by the Administrator as a port not embarkation quarantine. The pre- zoological park for a minimum of 1 year located in a region classified as R3, R4, or RU embarkation quarantine must be in a following the date the swine enters the for rinderpest or foot-and-mouth disease, or vector-proof facility approved by the park. If an APHIS veterinarian as a port in such a region having facilities Administrator and the National determines that the swine shows no and inspection approved by the Veterinary Services of the country of Administrator as adequate for maintaining signs of any illness at the end of this 1- wild animals in isolation from all other export if during a time of year when the year period, its manure and other wastes animals. insect vectors are active; and need not be disposed of within the park. 3. No ruminants or swine will be aboard (D) Have had a negative result to an If, however, an APHIS veterinarian the transporting vehicle, vessel or aircraft, approved serological test for JEV and/or determines that the swine does show except those for which an import permit has Getah during the pre-embarkation signs of any illness at the end of this 1- been issued. quarantine. year period, an APHIS veterinarian will 4. The animals will be quarantined for not (ii) The imported swine must undergo investigate the illness and determine less than 30 days in the Department’s Animal a minimum 15 day post-importation whether the swine’s manure and other Import Center in Newburgh, New York. quarantine in a facility designated and wastes may safely be disposed of 5. Upon release from quarantine, the approved by the Administrator. outside the zoological park. animals will be delivered to the zoological (3) Regions classified as Risk Class (iv) Prior to the issuance of an import park named in this agreement to become the property of the park, and they will not be R3, R4, or RU for JEV and/or Getah permit under this section, the operator sold, exchanged or removed from the virus. of the approved zoological park to premises without the prior consent of APHIS. (i) In addition to the export certificate which the wild swine are to be lllllllllllllllllllll requirements of § 93.505, the certificate Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17075 of export for live swine from regions (A) Were born and resided only in Administrator, until tested for M. bovis that are classified as Risk Class R3, R4, regions classified as Risk Class RN, R1, with negative results. or RU for JEV and/or Getah virus must or R2 forM. bovis; and (h) Teschen disease virus—(1) Regions certify that the swine to be imported: (B) That all boars and intact females classified as Risk Class R1 or R2 for (A) Have undergone pre-embarkation have had a negative result to an Teschen disease virus. In addition to the quarantine for at least 60 days approved test forM. boviswithin 60 days export certificate requirements of immediately prior to export, in a vector- prior to export. § 93.505, the certificate of export for live proof facility approved by the (ii) All boars and intact females must swine from foreign regions that are Administrator if during a time of year be detained at the port of entry or post- classified as Risk Class R1 or R2 for when the insect vectors are active; importation quarantine a minimum of Teschen disease virus must certify that (B) Have not been vaccinated for 72 hours until tested for M. bovis with the swine to be imported: Japanese encephalitis or Getah virus; negative results. (i) Were born and resided only in and (3)Regions classified as Risk Class R3 regions classified as Risk Class RN, R1 (C) Have been tested twice, within 60 for M. Bovis.(i) In addition to the export or R2 for Teschen disease virus; days prior to export and at least 30 days certificate requirements of § 93.505, the (ii) Have not been vaccinated with apart, with negative results using a certificate of export for live swine from any Teschen disease vaccine; and serological test approved by the regions that are classified as R3 forM. (iii) Had a negative result to an Administrator for JEV and/or Getah bovismust certify that the swine to be approved test for Teschen disease virus. imported: within 30 days of the date of (ii) The imported swine must be exportation. quarantined at a post-importation (A) Have never been on any premises while animals affected withM. (2) Regions classified as Risk Class R3 quarantine facility designated and for Teschen disease virus. (i) In addition approved by the Administrator for at bovishave been present on those same premises; to the export certificate requirements of least 15 days if imported during a § 93.505, the certificate of export for live season of the year when vectors are not (B) Were born and resided only in regions classified as Risk Class RN, R1, swine from regions that are classified as active or at least 60 days if imported Risk Class R3 for Teschen disease virus during a season of the year when vectors R2, or R3 for M. bovis; (C) Have had a negative result to an must certify that the swine to be are active in the United States. imported: (iii) During the post-importation approved test for M. bovis no less than 60 days nor more than 90 days prior to (A) Were born and resided only in quarantine period, the swine must be regions classified as Risk Class RN, R1, tested with negative results for JEV and/ export; and (D) For boars and intact females, the R2 or R3 for Teschen disease virus; or Getah virus, using approved (B) Have not been vaccinated with herd of origin has had a negative result serological tests. any Teschen disease vaccine; and to an approved test for M. bovis no less (g)Mycobacterium bovis (M. (C) Meet one of the following than 4 months nor more than 12 months bovis).Any swine responding to an requirements: approved test forM. bovis shall be prior to the date of export. (1) Have had a negative result with an refused entry into the United States. (ii) All boars and intact females must approved test for Teschen disease 30 to Non-responders may be eligible for be detained at the port of entry or post- 60 days before exportation; entry based on their status as importation quarantine facility a (2) Originated from herds in which determined by part 77 of this chapter. minimum of 72 hours until tested with the entire herd over 6 months of age, has Swine imported for immediate slaughter negative results for M. bovis. had negative results to an approved test are exempt from theM. bovis testing and (4) Regions classified as R4 and RU for Teschen disease within 12 months quarantine requirements. Such swine for M. bovis. (i) In addition to the export prior to the date of exportation; or must be consigned from the port of certificate requirements of § 93.505, the (3) Were quarantined at least 30 days entry to a recognized slaughtering certificate of export for live swine over prior to export. establishment and there slaughtered 6 months of age from regions that are (ii) Swine must be quarantined after within 2 weeks from the date of entry. classified as Risk Class R4 or RU for M. being imported for at least 15 days at a Such swine must be moved from the bovis must certify that the swine to be post-importation quarantine station port of entry in conveyances closed with imported: approved by the Administrator. official seals of the United States (A) Have never been on any premises (iii) During the post-importation Government applied and removed by an while animals affected with M. bovis quarantine, the imported swine must APHIS representative, or an individual have been present on those same have negative results to an approved authorized for this purpose by an APHIS premises; serological test for Teschen disease representative. (B) Have had a negative result to an virus. (1)Regions classified as Risk Class R1 approved test for M. bovis 60 to 90 days (3) Regions classified as Risk Class R4 for M. bovis.In addition to the export prior to export; and RU for Teschen disease virus. (i) In certificate requirements of § 93.505, the (C) Originate from herds in which the addition to the export certificate certificate of export for live swine over entire herd has had a negative result to requirements of § 93.505, the certificate 6 months of age from regions that are an approved test for M. bovis no less of export for live swine from regions classified as Risk Class R1 forM. than 4 months nor more than 12 months that are classified Risk Class R4 or RU bovis,must certify that the swine to be prior to the date of exportation; and for Teschen disease virus must certify imported were born and resided only in (D) For boars and intact females, have that the swine to be imported: foreign regions that are classified as Risk undergone at least 60 days of pre- (A) Have not been vaccinated with Class RN or R1 forM. bovis; embarkation quarantine prior to export. any Teschen disease vaccine; (2)Regions classified as Risk Class R2 (ii) Boars and intact females must be (B) Originate from herds in which the for M. bovis.(i) In addition to the export quarantined after being imported for a entire herd over 6 months of age has had certificate requirements of § 93.505, the minimum of 30 days at a post- a negative result to an approved test for certificate of export for such swine must importation quarantine facility Teschen disease within 60 to 180 days certify that the swine to be imported: designated and approved by the prior to the date of exportation; 17076 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

(C) Were quarantined for at least 60 (j) Vesicular Stomatitis virus (VSV)— § 93.516 Importation of swine through the days prior to export; and (1) Regions classified as Risk Class R1 Harry S Truman Animal Import Center (D) During pre-embarkation for VSV. In addition to the export (HSTAIC). quarantine period, have had negative certificate requirements of § 93.505, the (a) Exclusive right to use HSTAIC. The results to an approved test for Teschen certificate of export for live swine from Animal and Plant Health Inspection disease 30 to 60 days prior to the date regions that are classified as Risk Class Service will enter into a cooperative- of export. R1 for VSV must certify that the swine service agreement with only one (ii) The swine must be quarantined to be imported: importer for each importation through after being imported for at least 30 days (i) Have resided for at least 60 days the Harry S Truman Animal Import at a post-importation quarantine facility. prior to export only on premises located Center (HSTAIC). Applications for the (iii) During the post-importation in Risk Class RN or R1 regions for VSV; HSTAIC lottery will not be accepted quarantine the imported swine must and from, and a cooperative-service have two negative results not less than (ii) Have not been vaccinated for VSV. agreement to use HSTAIC will not be 30 days apart to an approved test for (2) Regions classified as Risk Class R2 offered to or entered into with, any Teschen disease. for VSV. In addition to the export person who has debts owing to APHIS (i) African (Salivarian or Tsetse certificate requirements of § 93.505, the that have not been paid by the date transmitted) Trypanosomes—(1) certificate of export for live swine specified in APHIS’s original billing Regions classified as Risk Class R1 and imported from regions that are classified notification to the person. Any person R2 for African trypanosomes. In as Risk Class R2 for VSV must certify who has debts owing to APHIS that addition to the export certificate that the swine to be imported: have not been paid by the date specified requirements of § 93.505, the certificate (i) Have resided for at least 30 days in APHIS’s original billing notification of export for live swine from regions prior to export only on premises located to that person will be removed from the that are classified as Risk Class R1 and in Risk Class RN, R1, or R2 regions for current priority list. An importer R2 for African trypanosomes must VSV; granted the exclusive right to use certify that the swine to be imported: (ii) Have not been vaccinated with HSTAIC may include in his or her (i) Have resided only on premises any live attenuated vaccines for VSV; allotted number, animals of the same located in regions classified as Risk and species belonging to other persons Class RN, R1 and R2 for trypanosomes (iii) Have not been vaccinated with interested in importing animals through and tsetse flies (Glossina spp.) for their inactivated vaccines for VSV within 60 HSTAIC, except that llamas and alpacas entire life; days prior to export. may be included in the same (2) Regions classified as Risk Class (ii) Have not been vaccinated for importation. However, APHIS will deal R3, R4, and RU regions for VSV. (i) In trypanosomes; and exclusively with the importer in whose addition to the export certificate (iii) Have had a negative result to an name the application for use of HSTAIC requirements of § 93.505, the certificate approved serological test for African was submitted. The Animal and Plant of export for live swine imported from trypanosomes within 30 days prior to Health Inspection Service will hold this regions that are classified as Risk Class entry into the United States. importer solely responsible for all costs R3, R4, and/or RU for VSV must certify (2) Regions classified as Risk Class (excepting capital expenditures at that the swine to be imported: R3, R4, and RU for African HSTAIC) incurred during the animal (A) Have not been vaccinated with Trypanosomes. (i) In addition to the qualification process. The animal any live attenuated vaccines for VSV; qualification process begins on the date export certificate requirements of (B) Have not been vaccinated with the cooperative-service agreement is § 93.505, the certificate of export for inactivated vaccines for VSV within 60 delivered to the address listed on the swine from regions classified as Risk days prior to export; Class R3, R4, and RU for African (C) Have not been located on any importer’s HSTAIC application, for the trypanosomes and Tsetse flies (Glossina premises where VSV has occurred importer’s signature, if HSTAIC is not spp.) must certify that the swine to be during the 60 days prior to export; and available to other importers, up to a imported: (D) If exported during a season of the maximum of 30 days. A cooperative- (A) Originated from premises that year when insect vectors were active: service agreement will be deemed to have not had trypanosomiasis diagnosed (1) Were quarantined and isolated have been delivered when the importer during the previous 24 months; from all animals not part of the signs the U.S. Postal Service domestic (B) Were quarantined and isolated at shipment for at least 30 days prior to return receipt, or the importer refuses least 60 days prior to export in a vector- export, in a vector-proof facility delivery of the cooperative-service proof facility approved by the approved by the Administrator; and agreement by the U.S. Postal Service, or administrator; (2) During the pre-embarkation the cooperative-service agreement is (C) Have not been vaccinated for quarantine period, had negative results returned by the U.S. Postal Service as trypanosomes; and to an approved serological test for VSV either unclaimed or undeliverable. (D) During the pre-embarkation within 14 days prior to export. HSTAIC can accommodate a finite quarantine period, had negative results (ii) If imported during a season of the number of animals at one time, but the to an approved serological test for year when insect vectors are active maximum allowed for a particular trypanosomes. within the United States, the imported importation will vary, depending on the (ii) The imported swine must be swine: size of the species. The Animal and quarantined for at least 30 days at a (A) Must be quarantined for at least 15 Plant Health Inspection Service will post-importation quarantine facility days at a post-importation quarantine specify this figure in the cooperative- designated and approved by the facility designated and approved by the service agreement, reproduced in Administrator. Administrator; and paragraph (d) of this section. (iii) During the post-embarkation (B) During the post-importation (b) Scheduling. Applications from quarantine period the swine will be quarantine period, must have negative prospective users of HSTAIC are retested at least once for trypanosomes results to an approved serological test processed according to the following using approved serological tests. for VSV. system: Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17077

(1)(i) All applications for use of October 1 and no later than October 15 (6) The Secretary of Agriculture may HSTAIC. To qualify to use HSTAIC, an of that year. grant priority over other applications to importer must submit a completed (ii) One application is required for an application from an agency of the application,11 providing estimates when each importation proposed. Deposits United States Government, if for an exact information as required on the required by paragraph (b)(1)(ii) of this importation potentially of value to the application form is unavailable. section must be received by APHIS at general public, and if received before least 7 calendar days prior to the date (ii) Each applicant for the importation July 15 of the year preceding the of the lottery. proposed importation.13 of animals through HSTAIC must make However, an (3) The priority list established by the agency of the United States Government a deposit of $32,000 in the form of a annual December lottery will remain must submit its application in certified check or money order, payable effective from January 1 through accordance with this section, except in U.S. funds. The deposit of each December 31 of the next calendar year, that, an agency of the United States applicant who is not given the superseding all previous lists. Which Government must enter into an opportunity to use HSTAIC will be year’s list is used is governed by the interagency agreement with APHIS for a returned to the applicant at the end of date exclusive use of HSTAIC is offered deposit of $32,000 by certified check or the calendar year of the prospective and not by the date the applicant’s money order, payable in U.S. funds. importation, or whenever the applicant animals are scheduled to arrive at HSTAIC importations by agencies of the removes his or her name from the HSTAIC. United States government will be priority list described in paragraph (4) The names of all applicants whose limited to one per year, except when (b)(4) of this section. The Animal and applications have reached the Import- HSTAIC is available and the Import- Plant Health Inspection Service will Export Animals Staff, Veterinary Export Animals Staff, Veterinary draw on the deposit of the applicant Services, no earlier than October 1 and Services, has received no other whose application is selected, to pay for no later than October 15 (see paragraphs applications for its use during that year. the costs of preparing and maintaining (b) (1) and (2) of this section), and (c) Responsibilities of the applicant HSTAIC in readiness for the applicant’s whose deposits have reached APHIS at selected. By certified mail, return animals. A charge of $1,067 will be least 7 calendar days prior to the date receipt requested, APHIS will send a made for each day that HSTAIC is not of the lottery, will be drawn during the cooperative-service agreement to the available to another importer, starting December lottery. The order in which applicant being offered the exclusive on the date the cooperative-service names appear on the priority list will right to use HSTAIC, as provided in agreement is delivered to the address correspond to that established by the paragraph (d) of this section. The listed on the importer’s HSTAIC lottery. If the person first offered the applicant must, within 30 days of application, and ending either with the right to use HSTAIC does not ensure receipt, sign and ensure that the Import- day that APHIS receives the signed receipt of the cooperative-service Export Animals Staff, Veterinary cooperative-service agreement or the agreement by the Import-Export Services, receives the cooperative- day the applicant notifies APHIS in Animals Staff, Veterinary Services, service agreement. The cooperative- writing that he or she does not intend within 30 days of receiving the service agreement must be accompanied to sign the cooperative-service cooperative-service agreement, APHIS by a certified check or money order, or agreement, up to a maximum of 30 days. will void that offer, and make an offer an irrevocable letter of credit (the letter A cooperative-service agreement will be to the applicant next on the priority list. of credit having an effective date 90 deemed to have been delivered when The Animal and Plant Health Inspection days after the animals’ scheduled the importer signs the U.S. Postal Service will limit importations to one release date from HSTAIC), payable in Service domestic return receipt, or per importer for the period U.S. funds, for the amount specified in refuses delivery of the cooperative- encompassing the calendar year for the cooperative-service agreement. Any service agreement by the U.S. Postal which the lottery is held and the funds remaining from the $32,000 Service, or the cooperative-service following two calendar years, except deposit will be applied to the agreement is returned by the U.S. Postal when no other lottery participants are quarantine costs, and will be deducted Service as either unclaimed or prepared to use HSTAIC during the time from the balance due with the undeliverable. it would be available in those years. The cooperative-service agreement. For priority list established during the (2)(i) During the first seven days of importations requiring use of a pre- December lottery will remain in effect December 12, APHIS will hold a lottery, embarkation quarantine facility, during the calendar year following the randomly drawing the names of physical plans for the facility, including lottery, and will take precedence over applicants in an order that will site-specific blueprints and location, any applications received after October determine the order in which they will must be included when the cooperative- 15th. Applications received after be offered use of HSTAIC for an service agreement is returned to the October 15th will be added to the importation during the next calendar Import-Export Animals Staff, Veterinary priority list, with precedence year. To be included in the annual Services. established by the order in which the (1) An importer interested in animals December lottery, applications must Import-Export Animals Staff, Veterinary ineligible for importation because reach the Import-Export Animals Staff, Services, receives them. officials in the exporting country or Veterinary Services, no earlier than (5) If the Import-Export Animals Staff, region will not allow APHIS to provide Veterinary Services, does not receive the services prescribed in the 11 Application forms are available from, and must more than one application between cooperative-service agreement, may, be submitted to Veterinary Services, Animal and Plant Health Inspection Service, Import/Export October 1st and October 15th for the upon notification of this ineligibility Animals, National Center for Import and Export, December lottery, the December lottery 4700 River Road Unit 39, Riverdale, MD 20737– for that year will be canceled, and 13 If the Secretary grants priority to an application 1231. APHIS will grant the exclusive right to from an agency of the United States Government, 12 The Animal and Plant Health Inspection the Animal and Plant Health Inspection Service Service will publish a notice announcing the exact use HSTAIC for an importation during will publish a notice in the Federal Register prior date in the Federal Register at least 30 days in the next calendar year in the order to October 1 of the year preceding the proposed advance of the December drawing. applications are received. importation. 17078 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules from APHIS, propose to substitute (d) Cooperative-Service Agreement. United States; laboratory tests; medical animals available from another location. Each importer being granted the right to treatment; official travel by Animal and Plant If this importer has not returned the use HSTAIC must sign, and comply Health Inspection Service personnel, signed cooperative-service agreement with, the cooperative-service agreement including per diem expenses in the country from which the animals are being exported; within the 30 days specified in the with APHIS. A sample cooperative- courier services to transport test samples to cooperative-service agreement, APHIS service agreement for importers other the Foreign Animal Disease Diagnostic will return any portion of the importer’s than agencies of the United States Laboratory; salaries of HSTAIC personnel; all deposit that has not been expended. In government is reproduced in this supplies for animal care, maintenance, and that case, the applicant next in priority paragraph. (Agencies of the United testing during the quarantine and in the post- will be offered the exclusive right to use States government being granted the quarantine cleaning and disinfection of HSTAIC, in accordance with the right to use HSTAIC must enter into an HSTAIC; utilities and overhead, including procedures in this section. interagency agreement with APHIS.) support staff, during the quarantine and post- quarantine cleanup.) (2) The importer may not abrogate The amount of money the importer must his/her responsibility for costs incurred 5. To obtain from foreign government advance, left blank in the following officials authorizations granting Animal and after the signing of the cooperative- sample, will depend on figures unique Plant Health Inspection Service personnel service agreement, regardless of any to a particular importation. This amount free access to the PEQF, when quarantine in occurrences that prevent the will be specified in the cooperative- a PEQF is required, and permits for export. importation from proceeding as service agreement the importer receives. 6. To secure from animal carriers planned. permission for Animal and Plant Health (3) The importer signing the Cooperative-Services Agreement Between Inspection Service personnel to accompany cooperative-service agreement returned (Name of Importer) and the United States the animals to the PEQF, when quarantine in to the APHIS is responsible for paying Department of Agriculture, Animal and a PEQF is required, and from the PEQF to Plant Health Inspection Service all costs, excluding capital expenditures HSTAIC. llllll at HSTAIC, incurred in qualifying the The importer, , wishes to 7. To maintain and operate the PEQF, when quarantine in a PEQF is required, in specified animals for importation qualify animals for importation into the United States. The United States Department compliance with 9 CFR 92.431 of the Code through HSTAIC. A partial list of costs of Agriculture, Animal and Plant Health of Federal Regulations. for which the importer must assume Inspection Service, administers the Harry S 8. To accept as final the findings of the responsibility includes: expenses for Truman Animal Import Center (HSTAIC), a Administrator, Animal and Plant Health preparing and maintaining HSTAIC in facility through which the importer may Inspection Service, on the animals’ eligibility readiness for the importation; expenses import animals into the United States. to enter the PEQF, when quarantine in a for sentinel animals in the United To effect this importation, both parties PEQF is required, to enter HSTAIC, and to be States, when required, and for tested agree to the following terms: released from HSTAIC. animals prevented, for any reason, from The importer agrees: 9. To follow procedures prescribed by the moving from HSTAIC elsewhere within 1. To have this cooperative-service Animal and Plant Health Inspection Service, agreement in the office of the Animal and appropriate to the disease and pest status of the United States; laboratory tests; Plant Health Inspection Service’s Import- the quarantined animals. (When quarantine medical treatment; official travel by Export Animals Staff, Veterinary Services, in a PEQF is required, the presence in the APHIS personnel, including per diem within 30 days of the date of receipt, PEQF of even one animal either exposed to, expenses in the country from which evidenced by the postal return-receipt. or infected with, rinderpest, foot-and-mouth animals are being exported, when 2. To remit with the cooperative-service disease, hog cholera, African swine fever, required; courier services to transport agreement a certified check, money order, or swine vesicular disease, or certain other test samples to the Foreign Animal irrevocable letter of credit having an effective contagious, exotic diseases, automatically Disease Diagnostic Laboratory, when date that extends 90 days beyond the disqualifies all animals in the PEQF from required; salaries of HSTAIC personnel; animals’ scheduled release from HSTAIC, entering HSTAIC. The presence in HSTAIC all supplies for animals care, payable in U.S. funds to the United States of even one animal either exposed to, or Department of Agriculture, Animal and Plant infected with, one of the diseases referred to maintenance, and testing during the Health Inspection Service, in the amount of in this paragraph, automatically disqualifies quarantine and in the post-quarantine $llllll. (This amount represents the all animals in HSTAIC from moving cleaning and disinfection of HSTAIC; estimated cost (except capital expenditures at anywhere within the United States after the utilities and overhead, including HSTAIC) of qualifying the animals for period in quarantine.) support staff, during the quarantine and importation through HSTAIC, less any 10. To assume responsibility for disposal of post-quarantine cleanup. unused portion of the $32,000 deposited in quarantined animals that do not qualify to (4) Capital expenditures at HSTAIC conjunction with the application for the move into or within the United States. (In the constitute the only costs for which the exclusive right to use HSTAIC. case of animals disqualified while 3. To limit to llllll the number of quarantined in HSTAIC, the Animal and importer will not be held responsible. llllll (5) For costs incurred during any stage animals, species transported to Plant Health Inspection Service will stipulate HSTAIC for an importation scheduled to the conditions under which the disqualified of the importation through HSTAIC— begin on or about llllll and to end animals in HSTAIC must be destroyed. The that is, costs not calculated into the with the animals’ release from HSTAIC, importer must, within 10 days of notification amount collected from the importer in scheduled for llllll. from the Animal and Plant Health Inspection accordance with the cooperative-service 4. To assume liability for all costs (except Service, remove from the PEQF or HSTAIC, agreement—APHIS will bill the capital expenditures at HSTAIC) attributable animals untreatable or treated for, but not importer at a later date. Payment will be to preparing and maintaining HSTAIC in cured of, a communicable disease other than due upon receipt of the bill. readiness for the importation, and to foot-and-mouth disease or any of certain (6) The Animal and Plant Health qualifying animals for and through other exotic diseases. Animals removed from Inspection Service will return to the quarantine in the pre-embarkation quarantine HSTAIC must be moved out of the United importer any part of the money remitted facility (PEQF), when quarantine in a PEQF States or be destroyed under conditions is required, and in HSTAIC for importation stipulated by the Animal and Plant Health with the cooperative-service agreement into the United States. (A partial list of these Inspection Service.) set forth in paragraph (d) of this section costs would include expenses for sentinel 11. To assume responsibility for all costs that is not used to cover the non-capital animals in the United States and for tested the Animal and Plant Health Inspection costs of the importation through animals prevented, for any reason, from Service incurs during this importation, HSTAIC. moving from HSTAIC elsewhere within the excluding capital expenditures at HSTAIC. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17079

12. To pay, upon receipt, post-quarantine 7. That during the performance of this the importer’s physical plans and billings incurred during this importation, for cooperative-service agreement, the importer conducting an on-site inspection, costs exceeding the amount remitted with agrees to be bound by the Equal Employment approve a PEQF found to meet the this cooperative-service agreement plus the Opportunity and Nondiscrimination requirements of this section. Approval initial $32,000 deposit. provisions set forth in Exhibit A and the The Animal and Plant Health Inspection Nonsegregation of Facilities provisions set of a PEQF will expire at the end of the Service Agrees: forth in Exhibit B,1 which are attached to and specifically authorized quarantine. 1. To provide the personnel required to made part of this cooperative-service Subsequent importers granted use of perform inspections, laboratory procedures, agreement. HSTAIC and proposing to use one of the and examinations, and to provide on-site 8. That no member of, or delegate to, existing PEQFs must apply for approval supervision of the isolation, quarantine, care Congress may participate in, or benefit from, as if for a new facility. No more than and handling of animals on premises of this cooperative-service agreement. one PEQF will receive approval for a lllllllllllllllllllll origin, in the PEQF when quarantine in a specific HSTAIC importation. If the PEQF is required, and in HSTAIC. Date PEQF specified in the signed 2. To inform the importer of any lllllllllllllllllllll quarantined animals in the PEQF or in Importer cooperative-service agreement, as HSTAIC that fail to qualify for entry into the lllllllllllllllllllll provided in § 93.526(d), is not approved United States, and to inform the importer Date by APHIS, the importer may use an that he/she must assume responsibility for lllllllllllllllllllll alternative PEQF, provided it is their disposal. Administrator, Animal and Plant Health approved by APHIS during the 42 days 3. To finance capital expenditures at Inspection Service, United States Department following the date the importer signs the HSTAIC without charging the importer. of Agriculture. cooperative-service agreement. If a 4. To account for all money disbursed from § 93.517 Pre-embarkation quarantine PEQF closes down or loses its the amount remitted, and to provide the ‘‘approved’’ status for any reason, importer with a complete written accounting facility; criteria and standards for approval. upon termination of this cooperative-service Criteria for establishment of a pre- APHIS may approve a replacement agreement. embarkation quarantine facility outside following the method specified in this 5. To refund to the importer any part of the the United States for the purpose of paragraph (a)(4). (5) Permission to place swine in the money remitted with this cooperative-service importing swine into the United States foreign PEQF shall be given to any agreement that is not used to cover the non- that are eligible for importation only person who has received permission to capital costs of the importation through through the Harry S Truman Animal HSTAIC. import swine through the Harry S Import Center are as follows: Both parties agree: Truman Animal Import Center, unless (a) Establishment. (1) The 1. That this cooperative-service agreement the Administrator determines that Administrator may enter into an is effective upon signature by both parties. sufficient grounds exist whereby such agreement with one or more parties for 2. That this cooperative-service agreement person may be denied such permission. will not be signed by the Administrator if the the establishment of such a facility (6) Fees charged by the owner or Import-Export Animals Staff, Veterinary pursuant to the standards in paragraph Services, Animal and Plant Health Inspection operator for the use of such facility shall (b) of this section. be provided in private agreements Service, has not received this signed (2) To qualify for designation as a pre- between the owner or operator of the cooperative-service agreement, including the embarkation quarantine facility (PEQF) facility and the owners of the swine specified remittance for the amount due, by for a specifically authorized 4:30 p.m. on the thirtieth calendar-day after proposed for importation. Such fees importation, the facility must meet the the date on the United States Postal Service’s shall be nondiscriminatory and return receipt, evidencing its receipt by the requirements of paragraph (b) of this reasonable as determined by the importer. section. Administrator. 3. That this cooperative-service agreement (3) All costs associated with the (7) Approval of any approved PEQF will not be signed by the Administrator if the establishment and operation of such a may be withdrawn at any time by the cooperative-service agreement is not pre-embarkation quarantine facility Administrator, upon his or her accompanied by the physical plans for the shall be borne by the owner or operator PEQF, including its location and site-specific determination that any requirement of of such facility. this section is not being met. Before blueprints (except when quarantine in a (4) The Animal and Plant Health such action is taken, the operator of the PEQF is not required). Inspection Service requires that the facility will be informed of the reasons 4. That this cooperative-service agreement importer submit the physical plans for will be voided if the Administrator, Animal for the proposed actions and will be the PEQF for which he or she is and Plant Health Inspection Service, afforded opportunity to present his or requesting approval. The physical plans determines that the importer has not her views thereon, in accord with rules must include location of the facility and completed arrangements with the responsible of practice adopted by the site-specific blueprints. The importer officials in the exporting country by 4:30 Administrator. Upon withdrawal of p.m. on the date 42 calendar-days after the must send these physical plans, due approval, the operator, upon request, importer’s signing of this cooperative-service with the cooperative-service agreement shall be afforded opportunity for a agreement. as provided in § 93.526(d), to the hearing with respect to the merits or 5. That, if both parties agree, this Import-Export Animals Staff, National validity of such action; but such cooperative-service agreement may be Center for Import-Export, Veterinary amended in writing. withdrawal or refusal shall continue in Services, Animal and Plant Health 6. That either party may terminate this effect unless otherwise ordered by the Inspection Service, United States cooperative-service agreement upon giving Administrator. Rules of practice Department of Agriculture, 4700 River 30 days written notice to the other party, but concerning the hearing shall be adopted Road Unit 39, Riverdale, MD 20737– premature termination will not relieve the by the Administrator. importer of responsibility for costs incurred, 1231. The Animal and Plant Health (b) Standards for approval of pre- as provided in this cooperative-services Inspection Service will, after reviewing agreement, nor will it relieve the Animal and embarkation quarantine facilities— (1) Location. (i) The PEQF must be in Plant Health Inspection Service of 1 Import-Export Animal Staff, National Center for responsibility for providing the importer Import-Export, Veterinary Services, APHIS, USDA, an area isolated from ruminants, swine, with a complete written accounting of money will send each importer copies of Exhibits A and and poultry. It must be located near the disbursed from the amounts remitted. B along with the cooperative-services agreement. point of embarkation: A dock, if the 17080 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules swine will travel by ocean vessel; an (vii) A dipping vat of a concrete pit the facility must be located within the airport, if the swine will travel by plane. type with inspection chute, holding swine holding areas. (ii) The swine’s route from the PEQF pen, dripping pen, and post-drip area (iii) A sufficient supply of clean to the point of embarkation must be similar to USDA Extension Plan 5940, clothing, including towels and footwear, limited to regions free of ruminants, revised, must be provided.14 as determined by the Administrator to swine, and poultry. (viii) The waste management system be adequate to prevent the transmission (iii) The facility must be so situated must be carefully designed to meet all of livestock or poultry disease agents that there will be no contact between applicable sanitation and quarantine from the facility, must be maintained swine held in the facility with any other requirements and the existing within the quarantine area. species of animals. environmental standards of the country (iv) A continuous supply of hot and (iv) The facility must be so situated in which the pre-embarkation cold running water, including potable that it will be free from contact with quarantine facility is located. water for personnel, must be provided. water and waste effluents from local (3) Fencing. (i) The outer perimeter of (v) If lunch is to be eaten within the livestock or poultry. Water and waste all facilities must be surrounded by a facility, a lunch room must be provided effluents from the facility must be fence that must be of sufficiently small and all food entered into the facility disposed of in a manner determined by mesh as to preclude the entrance of must be approved by the supervising the Administrator to be adequate to small farm animals, including dogs, and United States government veterinarian. (vi) A separate room containing the insure no exposure to local livestock or of such height and strength as to prevent equipment for preparation and poultry. entrance of larger animals. This fence packaging of laboratory specimens with (2) Building. (i) The exterior of the must be located at least 200 feet from adequate office space, as determined by building must be of durable low- the building in which quarantined the Administrator, to perform his or her maintenance, waterproof type swine are to be held, except that, in an construction that will withstand duties must be provided for the urban or industrial area the location of supervising veterinary official. All repeated cleaning and disinfecting. the fence may be less than 200 feet as (ii) Roofs must be watertight. The records, equipment, and other materials determined by the Administrator, if styling and configuration of the roof of used in the facility, must be maintained such action will not increase the risk the swine holding building must within the quarantine facility for the that communicable disease agents of provide for optimum air circulation entire quarantine period. livestock or poultry will be throughout the facility. (vii) A separate area situated apart (iii) The interior finish of the building disseminated from the facility. from the swine holding area must be must be durable, washable, and of low (ii) In regions affected by cattle fever provided for necropsies and a means for maintenance type construction. The ticks all such facilities must be double the removal of the carcasses of dead floor must be concrete with no cracks or fenced, with the inner perimeter fence swine must be provided without crevices. located at least 15 feet from the outer breaking quarantine security. (iv) Mesh double screens must protect perimeter fence. When double fencing is (viii) A swine receiving area and a all open areas, so that insects cannot required, the space between the outer chute or stocks for restraint during gain access to the swine holding area. If and inner perimeter fences must be kept examination and veterinary inspection, the swine are removed from the double- free from all foliage at all times. as determined to be appropriate by the screened building before export to the (iii) The outer fence of the facility Administrator to permit examination of HSTAIC, or if the United States must be posted with signs in the swine, must be provided. Department of Agriculture Veterinarian appropriate language, which must (ix) Feed must be stored in such a in Charge of the quarantine operation convey the following: Restricted Area— manner that replenishment during the determines that insects capable of Keep Out, Quarantine Area—Keep Out, quarantine period does not require transmitting communicable animal or Registered Quarantine Area—Keep transporting vehicles to enter the disease agents are entering the swine Out. quarantine area. holding area, APHIS will require (4) Feed. The animal feed supply in (x) Equipment necessary for the care, implementation of a program of insect the PEQF must consist only of feed cleaning, feeding, waste disposal, and vector control. This vector control obtained from a country or region that handling of the swine must be provided program will involve treating swine, is classified as Risk Class RN, R1, or R2 and maintained within the quarantine building interiors, and environs with for foot-and-mouth disease, and for any area. (xi) Additional requirements as to United States Environmental Protection other exotic disease necessitating the security, physical plant and facilities, Agency-registered pesticides. The quarantine or that could jeopardize the and sanitation may be imposed by the pesticides must be used in the manner quarantine. Administrator in each specific case in prescribed on the United States (5) Other requirements. (i) Access into order to assure that the quarantine of the Environmental Protection Agency- the quarantine area must be through a swine in such facility will be adequate approved label, and in accordance with single door that must lead into a walk- to enable determination of their health the requirements of the government of through shower area with clothes status, prevent the spread of disease the country in which the PEQF is change areas located on either side of among swine in quarantine, and prevent located. the shower and adjacent thereto. (v) Stalls, pens, and runways must be (ii) Toilet and lavatory facilities as escape of animal disease agents from the constructed of sufficient height and determined by the Administrator to be facility. adequate to preclude transmission of strength to confine and restrain all Subpart HÐElephants, Hippopotami, livestock or poultry disease agents from swine simultaneously for daily Rhinoceroses, and Tapirs veterinary examinations. (vi) At least 70-foot-candle lighting 14 Copies of USDA Extension Plan 5940, revised, 50. In subpart H, § 93.800 would be must be provided in the inspection area. may be obtained from the Import/Export Animals amended by revising the introductory Staff, National Center for Import and Export, A minimum light of 30-foot-candle must Animal and Plant Health Inspection Service, United text and the definitions of Accredited be available in all other areas of the States Department of Agriculture, 4700 River Road veterinarian, Administrator, and United facility. Unit 39, Riverdale, MD 20737–1231. States, to read as follows: Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17081

§ 93.800 Definitions. 94.11 Dry-cured pork products from regions individual who is authorized by the classified as Risk Class R3, R4, or RU for Administrator to enforce this part. Whenever in this subpart the foot-and-mouth disease, rinderpest, following terms are used, unless the Birds. All members of the class Aves African swine fever, hog cholera, or (other than poultry or game birds). context otherwise requires, they shall be swine vesicular disease. construed, respectively, to mean: 94.12 Ruminant meat and edible products Carrier. For the purposes of § 94.6, from ruminants that have been in regions this term means the principal operator Accredited veterinarian. A classified as Risk Class R3, R4, or RU for of a means of conveyance. veterinarian approved by the bovine spongiform encephalopathy. Cervid. All species of deer, elk, and Administrator in accordance with part 94.13 Movement of meat and meat moose. 161 of this chapter to perform functions products. Cold spot. The area in a flexible specified in parts 1, 2, 3, and 11 of 94.14 Seizure, quarantine, and disposal of plastic cooking tube or other type of subchapter A, and subchapters B, C, and meat and meat products. container loaded with meat product, or D of this chapter, and to perform 94.15 Cancellation of compliance agreements. the areas at various points along the belt functions required by cooperative State- in an oven chamber, slowest to reach Federal disease control and eradication Authority: 7 U.S.C. 147a, 150ee, 161, 162, 450; 19 U.S.C. 1306; 21 U.S.C. 111, 114a, the required temperature during the programs. 134a, 134b, 134c, 134f, 136 and 136a; 31 cooking process. The cold spot(s) for Administrator. The Administrator of U.S.C. 9701; 42 U.S.C. 4331 and 4332; 7 CFR each container is experimentally the Animal and Plant Health Inspection 2.22, 2.80, and 371.2(d). determined before the cooking process Service, or any other employee of the begins and, once identified, remains § 94.0 Definitions. Animal and Plant Health Inspection constant. Service, United States Department of As used in this part, the following Contact. Known or potential Agriculture, delegated to act in the terms shall have the meanings set forth commingling of products of animals Administrator’s stead. in this section. during processing or storage, or while Administrator. The Administrator of being transported from any point to any * * * * * the Animal and Plant Health Inspection other point. Contact includes United States. All of the States of the Service, or any other employee of the simultaneous processing in the same United States, the District of Columbia, Animal and Plant Health Inspection facility, or storage or shipment in the Guam, the Northern Mariana Islands, Service, United States Department of same room, locker, or container, but not Puerto Rico, the Virgin Islands of the Agriculture, delegated to act in the necessarily the same storage facility or United States, and all other Territories Administrator’s stead. conveyance, as long as security and Possessions of the United States. Animal and Plant Health Inspection measures provided are determined to be * * * * * Service (APHIS). The Animal and Plant adequate by an authorized APHIS Health Inspection Service, United States representative. 51. Part 94 would be revised to read Department of Agriculture. Container. A receptacle, sometimes as follows: APHIS representative. Any individual refrigerated, that is designed to be filled employed by the Animal and Plant with cargo, sealed, and then moved, PART 94ÐIMPORTATION OF MEAT Health Inspection Service, United States without unsealing or unloading, aboard AND UNPROCESSED PRODUCTS Department of Agriculture, who is a variety of different transporting means FROM ANIMALS authorized to perform the services of conveyance. Sec. required by this part. Continental United States. The 49 94.0 Definitions. Approved facility. A facility approved States located on the continent of North 94.1 Importation of fresh, chilled, or frozen by the Administrator, upon his or her America and the District of Columbia. meat from ruminants or swine. determination that it has equipment and Department. The United States 94.2 Additional conditions for importation uses procedures that are adequate to Department of Agriculture (USDA). of fresh, chilled, or frozen meat from prevent the dissemination of plant pests Directly. Without unloading and ruminants and swine. and livestock or poultry diseases, and without stopping except for refueling, or 94.3. Fresh, chilled, or frozen products that it is certified by an appropriate for traffic conditions such as traffic (other than meat) and milk and milk government official as currently lights or stop signs. products of ruminants and swine. complying with the applicable laws for Exotic Newcastle disease (VVND). 94.4 Organs, glands, extracts, or secretions environmental protection. The velogenic, viscerotropic form of of ruminants or swine. Newcastle disease. 94.5 Importation of cured or cooked meat of Approved sewage system. A sewage ruminants or swine into the United system approved by the Administrator, Flock of origin. The flock in which the States from regions classified as Risk upon his or her determination that the eggs were produced. Class R3, R4, or RU for foot and-mouth system is designed and operated in such Food Safety and Inspection Service disease, rinderpest, African swine fever, a way as to preclude the discharge of (FSIS). The Food Safety and Inspection swine vesicular disease, and/or hog sewage effluents onto land surfaces or Service of the United States Department cholera. into lagoons or other stationary waters, of Agriculture. 94.6 Regulation of certain garbage. and otherwise is adequate to prevent the FSIS inspector. An individual 94.7 Carcasses, or parts or products of dissemination of plant pests and authorized by the Administrator, FSIS, carcasses, and eggs (other than hatching livestock or poultry diseases, and that it to perform the function involved. eggs) of poultry, game birds, or other is certified by an appropriate Game birds. Migratory birds, birds; importations from countries where Exotic Newcastle disease (VVND) or S. government official as currently including certain ducks, geese, pigeons, enteritidis is considered to exist. complying with the applicable laws for and doves (‘‘migratory’’ refers to 94.8 Disposal of meats ineligible for environmental protection. seasonal flight to and from the United importation. Authorized inspector. Any employee States); and free-flying quail, wild 94.9 Meat and other animal products; in- of the Animal and Plant Health grouse, and wild pheasants (as opposed transit movement and handling. Inspection Service, United States to those that are commercial, domestic, 94.10 Milk and milk products. Department of Agriculture, or any other or pen-raised). 17082 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

House. A structure, enclosed by walls Salmonella enteritidis, phage-type 4. regions that are classified as Risk Class and a roof, in which poultry are raised. A virulent type of Salmonella enteritidis R4 or RU for rinderpest or foot-and- Import (imported, importation) into serotype enteritidis. mouth disease is prohibited. the United States. To bring into the Salmonellosis. An infectious disease (b) Importation of fresh, chilled, or territorial limits of the United States. caused by species of Salmonella frozen meat from swine in regions that Incineration. Reduction to ash by bacteria. are classified as Risk Class R3, R4 or RU burning. Sentinel bird. A chicken that has been for hog cholera, African swine fever, or Indicator piece. A cube or slice of raised in an environment free of swine vesicular disease is prohibited. meat to be used for the pink juice test, pathogens that cause communicable (c) Importation of fresh, chilled, or required to meet minimum size diseases of poultry and that has not frozen meat from ruminants from specifications. been infected with, exposed to, or regions that are classified as Risk Class Operator. The operator responsible for immunized with any strain of virus that R4 or RU for bovine spongiform the day-to-day operations of a facility. causes Newcastle disease. encephalopathy is prohibited. Person. Any individual, corporation, Shelf-stable. The condition achieved (d) Fresh, chilled, or frozen meat from company, association, firm, partnership, in a product, by application of heat ruminants or swine raised and society, joint stock company, or other alone or in combination with other slaughtered in regions classified as Risk legal entity. ingredients and/or other treatments, of Class RN or R1 for foot-and-mouth Pink juice test. Determination of being rendered free of microorganisms disease, rinderpest, bovine spongiform whether meat has been thoroughly capable of growing in the product under encephalopathy, African swine fever, cooked by observation of whether the nonrefrigerated conditions (over 50 °F hog cholera, and/or swine vesicular flesh and juices have lost all red and or 10 °C). disease may be imported into the United pink color. Sterilization. For purposes of § 94.6, States provided: Port of arrival. Any place in the this term means the cooking of regulated (1) The authorized official of the United States at which a product or garbage at 212 °F. (100 °C.) for 30 exporting country certifies on the article arrives, unless the product or minutes. foreign meat inspection certificate that article remains on the means of Swine. The domestic hog and all the shipment originated from regions conveyance on which it arrived within varieties of wild hogs. that are classified as Risk Class RN or R1 the territorial limits of the United States. Temperature indicator device (TID). A for foot-and-mouth disease, rinderpest, Poultry. Chickens, turkeys, swans, precalibrated temperature-measuring bovine spongiform encephalopathy, partridges, guinea fowl, pea fowl; instrument containing a chemical African swine fever, hog cholera, and nonmigratory ducks, geese, pigeons, and compound activated at a specific swine vesicular disease in ruminants or doves; commercial, domestic, or pen- temperature (the melting point of the swine; raised grouse, pheasants, and quail. chemical compound) identical to the (2) The authorized official of the Premises of origin. The premises processing temperature that must be exporting country certifies on the where the flock or herd of origin is kept. reached by the meat being cooked. foreign meat inspection certificate that Region. Any defined geographic land Territories or possessions. For § 94.6, the meat has not been in contact with region identifiable by geological, territories or possessions means Guam, meat from regions that are classified as political or surveyed boundaries. the Northern Mariana Islands, Puerto Risk Class R2, R3, R4, or RU for foot- Region of origin. For meat and meat Rico, and the Virgin Islands of the and-mouth disease, rinderpest, bovine products, the region in which the United States, and all other territories or spongiform encephalopathy, African animal from which the meat or meat possessions of the United States. swine fever, hog cholera, and/or swine product was derived was raised and Thoroughly cooked. Heated vesicular disease. slaughtered; and for eggs, the region in sufficiently to inactivate any pathogen (e) Fresh, chilled, or frozen meat from which the eggs were laid. In those cases that may be present, as indicated by the ruminants or swine raised and where the animal was raised in one required TID or pink juice test. slaughtered in regions that are classified region and slaughtered in another, the United States. All of the States of the as Risk Class R2 for foot-and-mouth region of origin is the region with the United States, the District of Columbia, disease or rinderpest may be imported classification of greater disease risk. Guam, the Northern Mariana Islands, into the United States provided that the Restricted agents. Livestock disease Puerto Rico, the Virgin Islands of the authorized official of the exporting agents, vectors, or hosts of those agents United States, and, for the purposes of country certifies on the foreign meat not known to exist in the United States this part other than § 94.6, all other inspection certificate that: or that are subject to control or territories or possessions of the United (1) Each shipment originates from eradication programs within the United States. regions that are classified as Risk Class States. Restricted agents are listed in Veterinarian in Charge. The RN, R1, or R2 for foot-and-mouth § 92.2 of this chapter. veterinary official of the Animal and disease or rinderpest in ruminants or Risk Class regions. Foreign exporting Plant Health Inspection Service, United swine; regions designated by APHIS according States Department of Agriculture, who (2) The meat has not been in contact to the results of a risk assessment as is assigned by the Administrator to with meat from regions that are defined in § 92.1 of this chapter and supervise and perform the official classified as Risk Class R3, R4 or RU for determined by criteria set forth in § 92.3 animal health work of the Animal and foot-and-mouth disease or rinderpest in of this chapter are incorporated herein Plant Health Inspection Service in the ruminants or swine; and are applicable to this part. State concerned. (3) The meat originates from premises Ruminants. All animals that chew the Wild swine. Any swine that are where foot-and-mouth disease or cud, such as cattle, buffaloes, sheep, allowed to roam outside an enclosure. rinderpest has not been present during goats, deer, antelopes, camels, llamas the lifetime of any ruminants or swine and giraffes. § 94.1 Importation of fresh, chilled, or slaughtered for export; Salmonella enteritidis. Salmonella frozen meat from ruminants or swine. (4) The meat originates from premises enteritidis serotype enteritidis, an (a) Importation of fresh, chilled, or located in regions where foot-and- organism that causes salmonellosis. frozen meat from ruminants or swine in mouth disease or rinderpest has not Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17083 been diagnosed within the previous 12 (6) The meat originates from swine before export, during which time the months; that have not been vaccinated for premises of origin of all animals in the (5) The meat originates from premises rinderpest, African swine fever, hog shipment remained free of foot-and- on which ruminants or swine have not cholera or swine vesicular disease at mouth disease, rinderpest, African been vaccinated with modified or any time during the lifetime of any of swine fever, hog cholera, and swine attenuated live viruses for foot-and- the swine slaughtered for export; and vesicular disease. mouth disease at any time during the (7) All bone, blood clots, and (h) Fresh, chilled, or frozen meat from lifetime of any of the ruminants or lymphoid tissue have been removed cattle from regions that are classified as swine slaughtered for export; from the meat. Risk Class R2 or R3 for bovine (6) The meat originates from (g) Fresh, chilled, or frozen meat from spongiform encephalopathy may be ruminants or swine that have not been ruminants or swine raised and imported into the United States vaccinated for rinderpest, African swine slaughtered in regions that are classified provided the authorized official of the fever, hog cholera or swine vesicular as Risk Class R3 for foot-and-mouth exporting country certifies that: disease at any time during the lifetime disease and/or rinderpest may be (1) Each shipment originates from a of any of the ruminants or swine imported into the United States, region that is classified as Risk Class slaughtered for export; provided the authorized official of the RN, R1, R2, or R3 for bovine spongiform (7) The meat comes from carcasses exporting country certifies that: encephalopathy; that have been allowed to maturate at 40 (1) Each shipment originates from a (2) The meat has not been in contact to 50 °F (4 to 10 °C) for a minimum of region that is classified as Risk Class with meat from regions that are 36 hours after slaughter and have RN, R1, R2 or R3 for foot-and-mouth classified as Risk Class R4 or RU for reached a maximum pH of 6.0 in the disease and/or rinderpest in ruminants bovine spongiform encephalopathy; loin muscle at the end of the maturation or swine; (3) The meat originates from premises period. Any carcass in which the pH (2) The meat has not been in contact where, for at least 10 years, bovine does not reach a maximum of 6.0 may with meat from regions that are spongiform encephalopathy has not be allowed to maturate an additional 24 classified as Risk Class R4 or RU for been known to be present; hours and be retested, and, if the carcass foot-and-mouth disease and/or (4) The meat originates from premises still does not reach a maximum pH of rinderpest; where protein of ruminant origin has 6.0 after 60 hours, the meat from the (3) The meat originates from premises not been fed to ruminants during the carcass may not be exported to the where foot-and-mouth disease and lifetime of any animals currently living United States; and rinderpest have not been present during on the premise; (8) All bone, blood clots, and the lifetime of any ruminants or swine (5) The meat is from cattle that have lymphoid tissue have been removed slaughtered for export; not been in any region that is classified from the meat. (4) The meat originates from premises as Risk Class R3, R4, or RU for bovine (f) Fresh, chilled, or frozen meat from where foot-and-mouth disease and/or spongiform encephalopathy during any swine raised and slaughtered in regions rinderpest has not been diagnosed period of time when the region that are classified as Risk Class R2 for within 15 statute miles (25 kilometers) permitted the use of ruminant protein in African swine fever, hog cholera, and/or within the previous 12 months; ruminant feed; and swine vesicular disease may be (5) The meat originates from premises (6) The cattle were examined prior to imported into the United States on which ruminants or swine have not slaughter by a veterinarian employed by provided that the authorized official of been vaccinated with modified or the national government of the country the exporting country certifies that: attenuated live viruses for foot-and- in which the ruminants were (1) Each shipment originates from mouth disease at any time during the slaughtered, and were found not to regions that are classified as Risk Class lifetime of any of the ruminants or display any signs indicative of a RN, R1, or R2 for African swine fever, swine slaughtered for export; neurological disorder. hog cholera, and/or swine vesicular (6) The meat originates from (i) Fresh, chilled or frozen meat disease in swine; ruminants or swine that have not been derived from animals in the family (2) The meat has not been in contact vaccinated for rinderpest, African swine Cervidae (cervids) from regions that are with meat from regions that are fever, hog cholera or swine vesicular classified as Risk Class R2, R3, or R4 for classified as Risk Class R3, R4 or RU for disease at any time during the lifetime bovine spongiform encephalopathy may African swine fever, hog cholera, and/or of any of the ruminants or swine be imported into the United States, swine vesicular disease; slaughtered for export; provided the authorized official of the (3) The meat originates from premises (7) The meat comes from carcasses exporting country certifies that: where African swine fever, hog cholera, that have been allowed to maturate at 40 (1) The meat was derived either from and/or swine vesicular disease has not to 50 °F (4 to 10 °C) for a minimum of wild cervidae, or from farm-raised been present during the lifetime of 36 hours after slaughter and that have cervidae that have never been fed swine slaughtered for export; reached a maximum pH of 6.0 in the ruminant protein; (4) The meat originates from premises loin muscle at the end of the maturation (2) All bones and visually identifiable located in regions where African swine period. Any carcasses in which the pH lymphatic tissue and nerve tissue have fever, hog cholera, and/or swine did not reach a maximum of 6.0 may be been removed from the meat; vesicular disease has not been allowed to maturate an additional 24 (3) The meat is from cervidae that diagnosed within the previous 12 hours and be retested, and if the carcass have not been in any region that is months; still does not reach a maximum pH of classified as Risk Class R3, R4, or RU for (5) The meat originates from premises 6.0 after 60 hours, the meat from the bovine spongiform encephalopathy, on which ruminants or swine have not carcass may not be exported to the during a period of time when the region been vaccinated with modified or United States; permitted the use of ruminant protein in attenuated live viruses for foot-and- (8) The meat has all bone, blood clots, ruminant feed; and mouth disease at any time during the and lymphoid tissue removed; and (4) The cervidae were examined prior lifetime of any of the swine slaughtered (9) The meat was held at no more than to slaughter by a veterinarian employed for export; 40 °F (4 °C) for a minimum of 14 days by the national government of the 17084 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules country in which the ruminants were log signed by the officer-in-charge, or cholera only under the following slaughtered, and were found not to certification from a foreign government conditions and the applicable display any signs indicative of a that the original seal was removed and conditions of paragraph (b), (c), (e), (f), neurological disorder. the new seal was applied by officials of (h), or (i) of this section: that government) that demonstrates to (1) All cured or cooked meat and meat § 94.2 Additional conditions for the satisfaction of the Administrator that products prepared under this section importation of fresh, chilled, or frozen meat the meat was not contaminated or must be prepared in an inspected from ruminants and swine. exposed to contamination during establishment that is eligible to have its All fresh, chilled, or frozen meat movement from the region of origin to products imported into the United permitted to be imported may be the United States; and States under the Federal Meat imported into the United States only (f) The meat is found by an authorized Inspection Act (21 U.S.C. 601 et seq.) under the conditions of § 94.1 and the inspector to be as represented on the and § 327.2 of this title. A foreign meat following conditions: foreign meat inspection certificate. inspection certificate required by (a) The meat is accompanied by the § 327.4 of this title shall be issued by an foreign meat inspection certificate § 94.3 Fresh, chilled, or frozen products official of the national government of required by § 327.4 of this title and, (other than meat) and milk and milk products of ruminants and swine. the country of origin who is authorized upon arrival of the meat in the United to issue the certificate, who further (a) The importation of fresh, chilled, States, the foreign meat inspection certifies on the same foreign meat or frozen products (other than meat, and certificate is presented to an authorized inspection certificate that the conditions milk and milk products) derived from inspector at the port of arrival; of this section have been fulfilled; and (b) The meat is placed in the ruminants or swine, originating in, (2) Upon arrival of the cured or transporting means of conveyance in a shipped from, or transiting any region cooked meat or meat products in the hold or compartment, or, if the meat is that is classified as Risk Class R3, R4 or United States, the accompanying foreign containerized, in a container, that was RU for rinderpest or foot-and-mouth meat inspection certificate must be sealed in the region of origin by an disease is prohibited, except as presented to an authorized inspector at official of the country of origin with provided in § 94.4 and parts 95 and 96 the port of arrival. serially numbered seals approved by the of this chapter. (b) The importation of cured meats Administrator of APHIS, so as to (b) The importation of milk and milk derived from ruminants or swine from prevent contact of the meat with any products of ruminants and swine any region of origin that is classified as other cargo, handling of the meat after originating in, shipped from, or Risk Class R3, R4, or RU for foot-and- the hold, compartment, or container is transiting any region that is classified as mouth disease or rinderpest is sealed, and the loading of any cargo into Risk Class R3, R4 or RU for rinderpest, prohibited, unless the requirements of and the removal of any cargo from the foot-and-mouth disease, or Brucella paragraph (a) of this section and the sealed hold, compartment, or container melitensis is prohibited, except as following conditions have been met: 3 en route to the United States; provided in § 94.10. (1) All bones have been completely (c) If any foreign official breaks a seal § 94.4 Organs, glands, extracts, or removed in the region of origin; applied in the region of origin in order secretions of ruminants or swine. (2) The meat has been held in an to inspect the meat, he or she must then The importation of fresh, chilled, or unfrozen, fresh condition for at least 3 reseal the hold, compartment, or frozen organs, glands, extracts, or days immediately following the container with a new serially numbered secretions derived from ruminants or slaughter of the animals from which it seal; and, if any member of a ship’s crew swine, from any region of origin was derived; breaks a seal, the serial number of the classified as Risk Class R3, R4 or RU (3) The meat has been thoroughly seal, the location of the seal, and the regions for foot-and-mouth disease, cured and fully dried in such a manner reason for breaking the seal must be rinderpest, African swine fever, hog that it may be stored and handled recorded in the ship’s log; cholera, swine vesicular disease, bovine without refrigeration, as in the case of (d) The serial numbers of the seals spongiform encephalopathy, or Brucella salami and other summer sausages, used to seal the hold, compartment, or melitensis is prohibited, except for tasajo, xarque, or jerked beef, bouillon container must be recorded on the pharmaceutical or biological purposes cubes, dried beef, and Westphalia, foreign meat inspection certificate that under conditions prescribed by the Italian and similar type hams. The term must accompany the meat; Administrator in each instance. ‘‘fully dried’’ as used in this paragraph (e) Upon arrival of the means of (b)(3) means dried to the extent that the conveyance in the United States port of § 94.5 Importation of cured or cooked water-protein ratio in the wettest arrival, the seals are found by an APHIS meat of ruminants or swine into the United portion of the product does not exceed representative to be intact, and the States from regions classified as Risk Class 2.25 to 1; and representative finds that there is no R3, R4 or RU for foot-and-mouth disease, (4) Laboratory analysis of samples to rinderpest, African swine fever, swine determine the water-protein ratios will evidence indicating that any seal has vesicular disease, and/or hog cholera. been tampered with; Provided that, if not be made in the case of all shipments the representative finds that any seal (a) Cured meats derived from of cured and dried meats. However, in ruminants or swine, except dry-cured any case in which the inspector is has been broken or has a different 1 2 number than is recorded on the foreign pork, or cooked meat may be imported uncertain whether the meat complies meat inspection certificate, then the into the United States from regions or with the requirements of paragraph meat may remain eligible for entry into origin that are classified as Risk Class (b)(3) of this section, he or she will send the United States only if APHIS R3, R4 or RU for foot-and-mouth a sample of the meat representative of personnel are available to inspect the disease, rinderpest, African swine fever, the wettest portion to the Meat hold, compartment, or container, the swine vesicular disease, and/or hog packages of meat, and all accompanying 3 See also other provisions of this part (including 1 See § 94.11 for importation requirements § 94.11) and parts 92, 95, and 96 of this chapter, and documentation; and the importer regarding dry-cured pork products. part 327 of this title for other prohibitions and furnishes additional documentation 2 This does not include any meat that has been restrictions upon importation of swine and swine (either copies of pages from the ship’s sterilized by heat in hermetically sealed containers. products. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17085

Inspection Division for analysis of the hours. Thoroughness of cooking must be (ii) The Administrator may deny water-protein ratio. Pending such determined by the TID registering at approval of any defrost facility if the analysis, the meat shall not be released least 79.4 °C at the cold spot, or by the Administrator determines that the or removed from the port of arrival. pink juice test, as follows: defrost facility does not meet the (c) The importation of cooked meat (i) Cubes of meat. At least 50 percent conditions for approval. If approval is from ruminants or swine originating in of meat pieces per tube must be 3.8 denied, the operator of the defrost any region classified as Risk Class R3, centimeters or larger in each dimension facility will be informed of the reasons R4, or RU for foot-and-mouth disease or after cooking or, if more than 50 percent for denial and be given an opportunity rinderpest is prohibited unless the of meat pieces per tube are smaller than to respond. The operator will be requirements of paragraph (a) of this 3.8 centimeters in any dimension after afforded an opportunity for a hearing section and the following conditions cooking and no TID is being used, an with respect to any disputed issues of have been met: indicator piece of sufficient size for a fact. The hearing will be conducted in (1) The cooked meat is boneless and pink juice test to be performed (3.8 accordance with rules of practice that has been thoroughly cooked; centimeters or larger in each dimension will be adopted for the proceeding. (2) The cooked meat has been after cooking) must have been placed at (iii) The Administrator may withdraw prepared in an establishment that is the cold spot of the tube. approval of any defrost facility as eligible to have its products imported (ii) Slices of meat. At least 50 percent follows: into the United States under the Federal of the slices of meat must be 3.8 (A) When the operator of the defrost Meat Inspection Act (21 U.S.C. 601 et centimeters or larger in each dimension facility notifies the Administrator in seq.) and the regulations in § 327.2 of after cooking or, if more than 50 percent writing that the defrost facility no longer this title; that meets all other applicable of meat pieces are smaller than 3.8 performs the required services; or requirements of the Federal Meat centimeters in any dimension after (B) When the Administrator Inspection Act and regulations cooking, and no TID is being used, an determines that the defrost facility does thereunder (9 CFR Chapter III); and that indicator piece of sufficient size for a not meet the conditions for approval. has been approved by the Administrator pink juice test to be performed (3.8 Before the Administrator withdraws in accordance with paragraph (d) of this centimeters or larger in each dimension approval from any defrost facility, the section; after cooking) must be placed at the cold operator of the defrost facility will be (3) Canned product (canned meat), as spot of the tube. informed of the reasons for the proposed defined in § 318.300(d) of this title, is (iii) Anatomical cuts of meat. An withdrawal and given an opportunity to exempt from the requirements in this indicator piece removed from an respond. The operator will be afforded section; anatomical cut of meat after cooking (4) Ground meat cooked in an oven. a hearing with respect to any disputed must be removed from the center of the The ground meat must be shaped into issues of fact. The hearing will be cut, farthest from all exterior points and patties no larger than 5 inches in conducted in accordance with rules of must be 3.8 centimeters or larger in each diameter and 1-inch thick. Each patty practice that will be adopted for the dimension for performance of the pink must weigh no more than 115 grams, proceeding. If approval of a defrost with fat content no greater than 30 juice test; facility is withdrawn, the Administrator (6) Any TID used in accordance with percent. These patties must be broiled at will remove its name from the list of § 94.5 (c)(4) or (c)(5) must remain in the 210 °C (410 °F) for at least 133 seconds, approved defrost facilities. meat, as originally inserted, and must then cooked in moist heat (steam heat) (d) Meat processing establishment; accompany the cooked meat whose in a continuous, belt-fed oven for not standards. (1) Before the Administrator temperature it has gauged when that less than 20 minutes, to yield an will approve a meat processing meat is shipped to the United States; internal exit temperature of at least 99.7 establishment for export shipment of and °C, (211.5 °F) as measured by cooked meat to the United States, the (7) The cooked meat must be temperature indicator devices (TID’s) Administrator must determine: inspected by an FSIS inspector at a port placed in temperature monitor patties (i) That the meat processing of arrival in a defrost facility approved positioned, before the belt starts moving establishment has furnished APHIS by the Administrator 4 and the meat through the oven, on each of the with a description of the process used must be found to be thoroughly cooked. to inactivate rinderpest or foot-and- predetermined cold spots along the (i) Request for approval of any defrost oven belt. TID’s approved by the mouth disease virus that may be present facility must be made to the in meat intended for export to the Administrator as activating at the Administrator. The Administrator will appropriate temperature must be placed United States, and with blueprints of approve a defrost facility only under the the facilities where this meat is cooked on the front, last, and predetermined following conditions: interior rows on the belt at the and packaged; (A) The defrost facility must have (ii) That an APHIS representative has beginning of each processing run; equipment and procedures that permit (5) Meat cooked in plastic. The inspected the establishment and found FSIS inspectors to determine whether ground meat, cubes of meat, slices of that it meets the standards set forth in meat is thoroughly cooked; meat, or anatomical cuts of meat (cuts paragraph (d)(2) of this section; (B) The defrost facility must be (iii) That the operator of the taken from the skeletal muscle tissue) located at a port of arrival; and must weigh no more than 5 kilograms, establishment has signed a cooperative (C) The defrost facility must be service agreement with APHIS, stating: and must be loaded into a flexible approved by FSIS.5 cooking tube constructed of plastic film (A) That all cooked meat processed or other material approved by the Food for importation into the United States 4 The names and addresses of approved defrost will be processed in accordance with Safety and Inspection Service, U.S. facilities and conditions for approval may be Department of Agriculture. The meat obtained from the National Center for Import and the requirements of this part; must be cooked in boiling water or in a Export, 4700 River Road Unit 39, Riverdale, MD 20737–1231. obtained from the Import Inspection Division, steam-fed oven to reach a minimum 5 ° Conditions for the approval of any defrost International Programs, Food Safety and Inspection internal temperature of 79.4 C at the facility by the Food Safety and Inspection Service, Service, United States Department of Agriculture, cold spot after cooking for at least 1.75 United States Department of Agriculture, may be Washington, DC 20250. 17086 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

(B) That a full-time, salaried meat with cold and hot water, soap, or RU for hog cholera), in a closed inspection official of the National disinfectants, paper towels, clothes container sealed by the national Government of the exporting country hampers and waste baskets for disposal, veterinary authorities of the region will supervise the processing (including and changing rooms stocked with the classified as Risk Class RN, R1, or R2 for certification of the cold spot) and clean clothing and rubber boots into hog cholera by seals of a serially examination of the product, and certify which all persons must change upon numbered type approved by the that it has been processed in accordance entering the establishment. Workers and Administrator; and with this section; and all other persons entering the (ii) The numbers of the seals used (C) That APHIS personnel or other establishment must wash their hands were entered on the meat inspection persons authorized by the Administrator and change into the clean clothing and certificate of the region that is classified may enter the establishment, boots provided in the changing rooms as Risk Class RN, R1, or R2 for hog unannounced, and will be given full before entering the cooking facilities, cholera that accompanied the shipment access to inspect the establishment and and must leave this clothing for from such region: And, provided its records; and laundering and disinfecting before further, that the certification 7 required (iv) That the operator of the exiting from the establishment, by paragraph (e) of this section also establishment has entered into a trust regardless of the amount of time spent states that: The container seals specified fund agreement with APHIS and is inside or away from the establishment; in paragraph (e)(3)(i) of this section current in paying all costs for an APHIS and were found intact and free of any representative to inspect the (iv) Original records identifying the evidence of tampering, by a national establishment for initial evaluation, and slaughtering facility from which the veterinary inspector upon arrival at the periodically thereafter, including travel, meat was obtained and the date the processing establishment; and the salary, subsistence, administrative meat entered the meat processing processing establishment from which overhead, and other incidental expenses establishment, and original certification the pork or pork product is shipped to (including an excess baggage provision (including temperature recording charts the United States does not receive or up to 150 pounds). In accordance with and graphs), must be kept for all cooked process any live swine; and uses only the terms of the trust fund agreement, meat by the full-time salaried meat pork or pork products that originate in before the APHIS representative’s site inspection official of the National regions that are classified as Risk Class inspection, the operator of the Government of the exporting country RN, R1 or R2 for hog cholera; and processing establishment must deposit assigned to the establishment, and must processes all such pork or pork products with the Administrator an amount equal be retained for 2 years. in accordance with this section. to the approximate cost of one (e) Importation of cured meats derived (f) Importation of cured meats derived inspection by an APHIS representative, from swine from any region of origin from swine from any region of origin including travel, salary, subsistence, that is classified as Risk Class R3, R4, or that is classified as Risk Class R3, R4, or administrative overhead, and other RU for hog cholera is prohibited, unless RU for swine vesicular disease is incidental expenses (including an the requirements of paragraph (a) of this prohibited, unless the requirements of excess baggage provision up to 150 section and the following conditions paragraph (a) of this section and the pounds). As funds from that amount are have been met and are certified to by the following conditions have been met and obligated, a bill for costs incurred based authorized official of the exporting are certified to by the authorized official on official accounting records will be country on the foreign meat inspection of the exporting country on the foreign issued to restore the deposit to the certificate: 6 meat inspection certificate: 8 original level, revised as necessary to (1) All bones have been completely (1) All bones have been completely allow for inflation or other changes in removed in the region of origin; removed in the region of origin; and estimated costs. To be current, bills (2) The meat has been held in an (2) Such pork or pork products either must be paid within 14 days of receipt. unfrozen, fresh condition for at least 3 are consigned directly from the port of (2) Establishment. An APHIS days immediately following the entry in the United States to a meat representative will conduct an on-site slaughter of the animals from which it processing establishment operating evaluation, and subsequent inspections, was derived; and under Federal meat inspection and 9 as provided in § 94.5(d)(1), to determine (3) The meat has been thoroughly approved by the Administrator, for whether the following conditions are heating to an internal temperature of cured and fully dried for a period of not ° ° met: less than 90 days so that the product is 166 F (74.4 C); or (i) The facilities used for processing shelf stable without refrigeration: (3) Such pork or pork product, if it is cooked meat in the meat processing Provided, That the period of curing and from a region of origin designated as a establishment are separate from the drying may be 45 days if the pork or Risk Class RN, R1, or R2 for swine facilities used for processing raw meat pork product is accompanied to the (precooking, boning, preparation, and 7 See footnote 6 in § 94.5(e). processing establishment by a certificate curing), with only the through-the-wall 8 See footnote 6 § 94.5(e). of an official of the national government cooking system through which the meat 9 The names and addresses of approved of a Risk Class RN, R1, or R2 region that product is delivered at the end of the establishments may be obtained from, and request specifies that: for approval of any establishment may be made to cooking cycle connecting them; and (i) The pork involved originated in a the National Center for Import and Export, there is at all times a positive air flow Veterinary Services, APHIS, 4700 River Road Unit region that is classified as Risk Class from the cooked to the raw product side; 39, Riverdale, MD 20737–1231. Establishments will (ii) The cooking equipment has the RN, R1, or R2, and the pork or pork be approved only if the Administrator determines capacity to cook all meat pieces in product was consigned to a processing that the imported articles will be so handled at the establishment in llllll (name of establishments as to prevent the introduction and accordance with § 94.5(c)(4) or (c)(5); dissemination of livestock or poultry diseases into (iii) Workers who process cooked a region classified as Risk Class R3, R4, the United States. Approval of any establishment meat are at all times kept separate from may be refused, suspended, or withdrawn only after 6 The certification required may be placed on the the operator thereof has been given notice of the workers who process raw meat, and foreign meat inspection certificate prescribed by proposed action and has had an opportunity to have for their exclusive use: A separate § 327.4 of this title, or may be contained in a present his or her views thereon, in accordance entrance, dining area, toilets, lavatories separate document. with rules of practice adopted by the Administrator. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17087 vesicular disease has been cured and country on the foreign meat inspection in a closed container sealed with dried and is in compliance with the certificate 10: serially numbered seals applied by an following requirements: (1) Such pork and pork product has official of the national government of (i) Such pork or pork product is been fully cooked by a commercial the country of origin; accompanied from the Risk Class RN, method in a container hermetically (B) The swine were accompanied R1 or R2 region of origin to the Risk sealed promptly after filling but before from the foreign region of origin to such Class R3, R4 or RU region by a such cooking, so that such cooking and processing establishment by a certificate certificate signed by an official of the sealing produced a fully sterilized signed by an official of the national National Government of the Risk Class product that is shelf-stable without government of the country of origin RN, R1 or R2 region of origin specifying refrigeration; or specifying the region of origin, the that the pork or pork product involved (2) Such pork or pork product is in processing establishment to which the originated in that region and that the compliance with the following pork was consigned, and the numbers of pork or pork product was consigned to requirements: the seals applied; a processing establishment in (i) All bones have been completely (C) The swine were taken out of the (llllll) (name of a region listed removed in the region of origin; and container at such processing as a Risk Class R3, R4 or RU region for (ii) Such pork or pork product has establishment only after an official of swine vesicular disease), in a closed received heat treatment in a the national government of the country container sealed by the national commercially accepted manner used for where such processing establishment is veterinary authorities of the Risk Class perishable canned pork products that located determined that the seals were RN, R1, or R2 region of origin by seals produces an internal temperature of intact and free of any evidence of of a serially numbered type approved by 156° F. tampering, and had so stated by the the Administrator. The numbers of these (i) Importation of cooked meat from certification referred to in paragraph seals must be entered on this certificate; swine originating in any region that is (i)(3)(i)(B) of this section; and classified as Risk Class R3, R4, or RU for (D) All bones were completely (ii) The certification required by African swine fever is prohibited, unless removed from the pork or pork product; paragraph (f)(3)(i) of this section must the requirements of paragraph (a) of this (E) The pork or pork product was also state that: section and the following conditions heated by other than a flash-heating (A) The container seals were found have been met and are certified to by the method at the foreign processing intact and free of any evidence of authorized official of the exporting establishment referred to in paragraph tampering upon arrival at the processing country on the foreign meat inspection (i)(3)(i)(A) of this section, to an internal ° ° establishment in the Risk Class R3, R4 certificate: temperature of at least 69 C. (156 F.) or RU region, by a national veterinary (1) Such pork or pork product has throughout (this must have occurred inspector of the country in which the been fully cooked by a commercial after the bones had been removed); and region is located; method in a container hermetically (F) The processing establishment (B) The processing establishment from sealed promptly after filling but before referred to in paragraph (i)(3)(i)(A) of which the pork or pork product was such cooking, so that such cooking and this section: shipped to the United States does not sealing produced a fully-sterilized (1) Does not receive or process any receive or process any live swine, and product that is shelf-stable without live swine, uses only pork or pork uses only pork or pork products that are refrigeration; or products that originate in regions that from regions of origin that are classified (2) Such pork or pork product is not are classified as Risk Class RN, R1 or R2 as Risk Class RN, R1, or R2 for swine otherwise prohibited importation under for African swine fever, and processes vesicular disease; and this part and is consigned directly from pork or pork products only in (C) Such establishment processes all the port of arrival in the United States accordance with paragraphs (i)(3)(i) and such pork or pork products in to a meat processing establishment (i)(3)(ii) of this section; accordance with this section. operating under Federal meat (2) Is operated by persons who have (g) Small amounts of pork or pork entered into a valid written compliance products subject to the restrictions of inspection, and approved by the Administrator, for further processing of agreement with APHIS whereby such this section, may, in specific cases, be persons have agreed to maintain on file imported for purposes of examination, such pork or pork product by heat; or (3) Such pork or pork product meets at the establishment for at least 2 years testing, or analysis, if the importer copies of the certifications referred to in applies for and receives written the following conditions: (i) It was derived from pork or pork paragraph (i)(3)(i)(B) of this section, and approval for such importation from the products that originated from swine to allow APHIS personnel to make Administrator, authorizing such raised and slaughtered in a region that unannounced inspections as necessary importation. Approval will be granted to monitor compliance with the only when the Administrator is classified as Risk Class RN, R1 or R2 for African swine fever, which were provisions of this section, and have determines that the articles have been agreed to otherwise comply with the processed by heat in a manner so that handled in the following manner: (A) The swine were shipped from the provisions of this section; and such importation will not endanger the (3) Is operated by persons who have livestock of the United States. region of origin to a processing establishment 11 in region that is entered into a trust fund agreement (h) Importation of cooked meat from executed by such persons and APHIS; swine from any region of origin that is classified as Risk Class RN, R1 or R2 for African swine fever, and were shipped pursuant to the trust fund agreement the classified as Risk Class R3, R4, or RU for establishment is current in paying the hog cholera and/or swine vesicular 10 cost for APHIS personnel to inspect the disease is prohibited unless the See footnote 6 in § 94.5(e). 11 As a condition of entry into the United States, establishment (it is anticipated that such requirements of paragraph (a) of this pork or pork products must also meet all of the inspections will occur once per year), section and the following conditions requirements of the Federal Meat Inspection Act (21 including travel, salary, subsistence, have been met and are certified to by the U.S.C. 601 et seq.) and regulations thereunder (9 administrative overhead, and other authorized official of the exporting CFR part 301), including requirements that the pork or pork products be prepared only in approved incidental expenses (including excess establishments. baggage provisions up to 150 pounds); 17088 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules and, in addition, the establishment has means of conveyance as prescribed by conveyance has not moved to the on deposit with APHIS, an unobligated this paragraph (b)(1)(i)(A) have been continental United States from any amount equal to the cost for APHIS disposed of according to the procedures territory or possession or from Hawaii; personnel to conduct one inspection; for disposing of regulated garbage, as to any territory or possession from any and specified in paragraph (f)(1) of this other territory or possession or from (ii) The pork or pork product was section. Hawaii; or to Hawaii from any territory processed at only one processing (B) That the means of conveyance had or possession. establishment in a region classified as been cleaned and disinfected in the (2) Exception 2. Garbage on or Risk Class R3, R4, or RU. presence of the inspector; and removed from an aircraft is exempt from (ii) Since being cleaned and requirements under paragraph (c) of this § 94.6 Regulation of certain garbage. disinfected, the means of conveyance section if the following two conditions (a) Garbage. For purposes of this has not been in a country other than the are met when the garbage is on or section, garbage means all waste United States or Canada. removed from the means of conveyance: material derived in whole or in part (2) Exception 2. Garbage on or (i) The aircraft had been cleared of all from fruits, vegetables, meats, or other removed from an aircraft is exempt from garbage and all fresh fruits and plant or animal (including poultry) requirements under paragraph (b) of this vegetables; and the items cleared from material, and other refuse of any section if the following two conditions the aircraft as prescribed by this character whatsoever that has been are met: paragraph (c)(2)(ii) have been disposed associated with any such material on (i) The aircraft had been cleared of all of according to the procedures for board any means of conveyance, and garbage and all stores; and the items disposing of regulated garbage, as including food scraps, table refuse, cleared from the aircraft as prescribed specified in paragraph (f)(1) of this galley refuse, food wrappers or by this paragraph (b)(2)(i) have been section; and packaging materials, and other waste disposed of according to the procedures (ii) After the garbage and stores material from stores, food preparation for disposing of regulated garbage, as referred to in paragraph (c)(2)(i) of this areas, passengers’ or crews’ quarters, specified in paragraph (f)(1) of this section were removed, the aircraft has dining rooms, or any other areas on the section. not moved to the continental United means of conveyance. For purposes of (ii) After the garbage and stores States from any territory or possession this subpart, garbage also means meals referred to in paragraph (b)(2)(i) of this or from Hawaii; to any territory or and other food that were available for section were removed, the aircraft has possession from any other territory or consumption by passengers and crew on not been in a country other than the possession or from Hawaii; or to Hawaii an aircraft but were not consumed. Not United States or Canada. from any territory or possession. all garbage is regulated for the purposes (c) Garbage regulated because of (d) Garbage that is commingled with of this section. Garbage regulated for the certain movements to or from Hawaii, regulated garbage is also regulated purposes of this section is defined as territories, or possessions. For purposes garbage. ‘‘regulated garbage’’ in paragraphs (b), of this section, garbage on or removed (e) Restrictions on regulated garbage. (c), and (d) of this section. from a means of conveyance is regulated (1) Regulated garbage may not be on or (b) Garbage regulated because of garbage, if the means of conveyance has removed from a means of conveyance, movements outside the United States or moved during the previous one-year or be disposed of, unless in accordance Canada. For purposes of this section, period, either directly or indirectly, to with the provisions of this part. garbage on or removed from a means of the continental United States from any (2) Regulated garbage is subject to conveyance is regulated garbage, if, territory or possession or from Hawaii; general surveillance for compliance when the garbage is on or removed from to any territory or possession from any with this section by APHIS inspectors, the means of conveyance, the means of other territory or possession or from and to such disposal measures as conveyance has been in any port or area Hawaii; or to Hawaii from any territory authorized by section 105 of the Federal outside the United States and Canada or possession. There are, however, two Plant Pest Act (7 U.S.C. 150dd), section within the previous 2-year period. There exceptions to this provision. These 10 of the Plant Quarantine Act of 1912, are, however, two exceptions to this exceptions are as follows: as amended (7 U.S.C. 164a), section 2 of provision. These exceptions are as (1) Exception 1. Garbage on or the Act of February 2, 1903, as amended follows: removed from a means of conveyance (21 U.S.C. 111), and section 306 of the (1) Exception 1. Garbage on or other than an aircraft is exempt from Act of July 17, 1930, as amended (19 removed from a means of conveyance requirements under paragraph (c) of this U.S.C. 1306), to prevent the other than an aircraft is exempt from section if the following two conditions dissemination of plant pests and requirements under paragraph (b) of this are met when the garbage is on or livestock or poultry diseases. section if the following conditions are removed from the means of conveyance: (f)(1) All regulated garbage must be met when the garbage is on or removed (i) The means of conveyance is contained in tight, leak-proof covered from the means of conveyance: accompanied by a certificate from an receptacles during storage on board a (i) The means of conveyance is APHIS inspector, stating that the means means of conveyance while in the accompanied by a certificate from an of conveyance has been cleared of all territorial waters, or while otherwise APHIS inspector stating the following: garbage and all fresh fruits and within the territory of the United States. (A) That the means of conveyance had vegetables; and the items cleared from All such receptacles must be contained first been cleared of all garbage and of the means of conveyance as prescribed inside the guard rail if on a watercraft. the following: All meats and meat by this paragraph (c)(1)(i) have been Such regulated garbage shall not be products, whatever the region of origin, disposed of according to the procedures unloaded from such means of except meats that are shelf-stable; all for disposing of regulated garbage, as conveyance in the United States unless fresh and condensed milk and cream specified in paragraph (f)(1) of this such regulated garbage is removed in from regions classified as Risk Class R3, section; and tight, leak-proof receptacles under the R4, or RU for foot-and-mouth-disease; (ii) After being cleared of the garbage direction of an APHIS inspector to an all fresh fruits and vegetables; and all and stores referred to in paragraph approved facility for incineration, eggs; and the items cleared from the (c)(1)(i) of this section, the means of sterilization, or grinding into an Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17089 approved sewage system, under regulated garbage must first enter into material fact. Rules of practice supervision by such an inspector, or an agreement with APHIS. Compliance concerning a hearing will be adopted by such regulated garbage is removed for agreement forms (PPQ Form 519) are the Administrator. This administrative other handling in such manner and available without charge from local remedy must be exhausted before a under such supervision as may, upon USDA, APHIS, Plant Protection and person can file suit in court challenging request in specific cases, be approved by Quarantine Offices, which are listed in the cancellation of a compliance the Administrator as complying with telephone directories. agreement. the applicable laws for environmental (2) A person who enters into a (5) Where a compliance agreement is protection and as adequate to prevent compliance agreement, and employees denied or canceled, an APHIS inspector the dissemination into or within the or agents of that person, must comply may allow the regulated garbage to be United States of plant pests and with the following conditions and any unloaded from a means of conveyance livestock or poultry diseases. supplemental conditions that shall be and disposed of at an approved facility (2) Application for approval of a listed in the compliance agreement, as in accordance with paragraph (f)(1) of facility or sewage system may be made deemed by the Administrator to be this section. in writing by the authorized necessary to prevent the dissemination representative of any carrier or by the into or within the United States of plant (Approved by the Office of Management and official having jurisdiction over the port pests and livestock or poultry diseases: Budget under control number 0579–0015) or place of arrival of the means of (i) Comply with the provisions of this § 94.7 Carcasses, or parts or products of conveyance, to the Administrator, section; carcasses, and eggs (other than hatching Animal and Plant Health Inspection (ii) Allow APHIS inspectors access to eggs) of poultry, game birds, or other birds; Service, U.S. Department of Agriculture, all records maintained by the person importations from countries where Exotic Washington, DC 20250. The application regarding handling or disposal of Newcastle disease (VVND) or S. enteritidis must be endorsed by the operator of the regulated garbage, and to all areas where is considered to exist. facility or sewage system. Approval will handling or disposal of regulated (a) Countries where Exotic Newcastle be granted if the Administrator garbage occurs; disease (VVND) is considered to exist. determines that the requirements set (iii) Remove regulated garbage from a (1) Exotic Newcastle disease (VVND) is forth in this section are met. Approval means of conveyance only in tight, leak- considered to exist in all countries of may be denied or withdrawn at any proof receptacles; the world except those listed in time, if the Administrator determines (iv) Move the receptacles of regulated paragraph (a)(2) of this section. that such requirements are not met, after garbage only to a facility approved in (2) The following countries are notice of the proposed denial or accordance with paragraph (f)(2) of this considered to be free of Exotic withdrawal of the approval and the section; and Newcastle disease (VVND): Australia, reasons therefor, and an opportunity to (v) At the approved facility, dispose of Canada, Chile, Denmark, Fiji, Finland, demonstrate or achieve compliance with the regulated garbage only through Great Britain (England, Scotland, Wales, such requirements, has been afforded to incineration, sterilization, grinding into and the Isle of Man), Iceland, New the operator of the facility or sewage a sewage system approved in Zealand, Northern Ireland, Norway, system and to the applicant for accordance with paragraph (f)(2) of this Republic of Ireland, Sweden, and approval. However, approval may also section, or in any other manner Switzerland. approved by the Administrator and be withdrawn without such prior (b) Countries where S. enteritidis, described in the compliance agreement. procedure in any case in which the phage-type 4, is considered to exist. (1) public health, interest or safety requires (3) Approval for a compliance agreement may be denied at any time if S. enteritidis, phage-type 4, is immediate action, and in such case, the considered to exist in all countries of operator of the facility or sewage system the Administrator determines that the requirements set forth in this section are the world except those listed in and the applicant for approval shall paragraph (b)(2) of this section. promptly thereafter be given notice of not met, after notice of, and the reasons (2) The following countries are the withdrawal and the reasons therefor for, the proposed denial of the approval, considered to be free of S. enteritidis, and an opportunity to show cause why and an opportunity to demonstrate or phage-type 4: Canada. the approval should be reinstated. achieve compliance with such (g) APHIS will cooperate with other requirements, has been afforded to the (c) Carcasses, and parts or products of Federal, State, and local agencies compliance agreement applicant. carcasses, from countries where VVND responsible for enforcing other statutes (4) Any compliance agreement may be is considered to exist. Carcasses, and and regulations governing disposal of canceled in writing by the parts or products of carcasses, of regulated garbage to the end that such Administrator whenever it is found that poultry, game birds, or other birds may disposal shall be adequate to prevent the person who has entered into the be imported only in accordance with the dissemination of plant pests and compliance agreement has failed to this section if they: are of poultry, game livestock or poultry diseases and comply with this section. Any person birds, or other birds that were raised or comply with applicable laws for whose compliance agreement has been slaughtered in any country where VVND environmental protection. The canceled may appeal the decision, in is considered to exist (see paragraph (a) inspectors, in maintaining surveillance writing, within 10 days after receiving of this section); are imported from any over regulated garbage movements and written notification of the cancellation. country where VVND is considered to disposal, shall coordinate their activities The appeal must state all of the facts exist; or are moved into or through any with the activities of representatives of and reasons upon which the person country where VVND is considered to the Environmental Protection Agency relies to show that the compliance exist at any time before importation or and other Federal, State, and local agreement was wrongfully canceled. As during shipment to the United States. agencies also having jurisdiction over promptly as circumstances allow, the (1) Carcasses of game birds may be such regulated garbage. Administrator will grant or deny the imported if eviscerated, with heads and (h) Compliance agreement and appeal, in writing, stating the reasons feet removed. Viscera, heads, and feet cancellation. (1) Any person engaged in for the decision. A hearing will be held removed from game birds are ineligible the business of handling or disposing of to resolve any conflicts as to any for entry into the United States. 17090 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

(2) Carcasses, or parts or products of where VVND or S. enteritidis, phage- before the certificate was signed. There carcasses, of poultry, game birds, and type 4, is considered to exist at any time was at least 1 sentinel bird per 1,000 other birds may be imported for before importation or during shipment poultry, with at least 30 sentinel birds consignment to any museum, to the United States. per house. The sentinel birds remained educational institution or other (1) With a certificate. The eggs may be free of clinical and immunological establishment that has provided the imported if they are accompanied by a evidence of VVND as demonstrated by Administrator with evidence that it has certificate signed by a salaried negative hemagglutination inhibition the equipment, facilities, and veterinarian of the national government tests conducted on blood samples capabilities to store, handle, process, or of the country of origin and: drawn at 10-day intervals by a salaried disinfect such articles so as to prevent (i) The eggs are imported in cases veterinary officer of the national the introduction or dissemination of marked with the identity of the flock of government of the country of origin. The viscerotropic velogenic Newcastle origin and sealed with the seal of the tests were conducted in a laboratory disease into the United States, and that national government of the country of located in the country of origin, and the is approved by the Administrator.12 origin. laboratory was approved to conduct the (3) Carcasses, or parts or products of (ii) The certificate accompanying the tests by the national government of that carcasses, of poultry, game birds, and eggs is presented to an authorized country; or other birds, may be imported if packed inspector when the eggs reach the port (2) Once every week, beginning at in hermetically sealed containers and if of arrival in the United States. least 60 days before the certificate was cooked by a commercial method after (iii) The certificate identifies the flock signed, a salaried veterinary officer of such packing to produce articles that are of origin and shows the country of the national government of the country shelf-stable without refrigeration. origin, the port of embarkation, the port of origin collected carcasses of all (4) Carcasses, or parts or products of of arrival, the name and address of the poultry that died during that week, and carcasses, of poultry, game birds, and exporter and importer, the total number the carcasses were examined for VVND other birds may be imported if of eggs, and cases of eggs, shipped with using the embryonated egg inoculation the certificate, and the date the thoroughly cooked, and if, upon technique. Once a month, beginning at certificate was signed. inspection by a representative of the least 60 days before the certificate was (iv) The certificate states that the eggs United States Department of Agriculture signed, a salaried veterinary officer of at the port of arrival, the carcasses or qualify for importation in accordance with this section. the national government of the country parts or products thereof have a of origin collected tracheal and cloacal thoroughly cooked appearance (v) No more than 90 days before the certificate was signed, a salaried swabs from not less than 10 percent of throughout. the poultry in the flock, and the swabs (5) Carcasses or parts or products of veterinary officer of the national were tested for VVND. All examinations carcasses, of poultry, game birds, and government of the country of origin and tests were conducted in a laboratory other birds that do not otherwise qualify inspected the flock of origin and found located in the country of origin, and the for importation under paragraph (c) of no evidence of communicable diseases laboratory was approved to conduct the this section may be imported only if the of poultry. tests and examinations by the national importer applies to, and is granted a (vi) The eggs were washed, to remove government of that country. All results permit by the Administrator authorizing foreign material from the surface of the were negative for VVND. such importation. Permission will be shells, and sanitized on the premises of origin with a hypochlorite solution of (x) And, if the eggs were laid in any given only when the Administrator country where S. enteritidis, phage-type determines that such importation will from 100 ppm to 200 ppm available chlorine. 4 is considered to exist (see paragraph not constitute a risk of introduction or (b) of this section): dissemination of viscerotropic velogenic (vii) The eggs were packed on the premises of origin in previously unused (A) No salmonellosis caused by S. Newcastle disease into the United enteritidis occurred on the premises of States. Application for a permit may be cases. (viii) Before leaving the premises of origin or on adjoining premises during made in accordance with paragraph (e) origin, the cases in which the eggs were the 90 days before the certificate was of this section. packed were sealed with a seal of the signed. (d) Eggs (other than hatching eggs) national government of the country of (B) There is no evidence that the flock from countries where VVND or S. origin by the salaried veterinarian who of origin was exposed to S. enteritidis enteritidis is considered to exist. Eggs signed the certificate. during the 90 days before the certificate (other than hatching eggs 13) from (ix) And, if the eggs were laid in any was signed. poultry, game birds, or other birds may country where VVND is considered to (C) The eggs are from a flock of origin be imported only in accordance with exist (see paragraph (a) of this section): found free of S. enteritidis as follows: this section if they: Are laid by poultry, (A) No VVND occurred on the (1) At least 60 days before the game birds, or other birds that were premises of origin or on adjoining certificate was signed, a veterinary raised in any country where VVND or S. premises during the 90 days before the medical officer of the national enteritidis, phage-type 4, is considered certificate was signed. government of the country of origin took to exist (see paragraphs (a) and (b) of (B) There is no evidence that the flock a blood specimen from a representative this section); are imported from any of origin was exposed to VVND during sample of at least 300 poultry in each country where VVND or S. enteritidis, the 90 days before the certificate was house, or, if any house contained fewer phage-type 4, is considered to exist; or signed. than 300 poultry, from all the poultry in are moved into or through any country (C) The eggs are from a flock of origin that house. The blood specimens were found free of VVND in one of the tested for S. enteritidis with Salmonella 12 The names and addresses of approved following ways: pullorum or S. enteritidis antigen using establishments may be obtained from, and requests 14 for approval may be made to the National Center (1) Sentinel birds were present in a tube or plate test. The tests were for Import and Export, 4700 River Road Unit 39, the flock of origin for at least 60 days Riverdale, Maryland 20737–1231. Services, Animal and Plant Health Inspection 13 The requirements for importing hatching eggs 14 For information on sources of sentinel birds, Service, 4700 River Road Unit 33, Riverdale, MD are contained in part 93 of this chapter. contact the Operational Support Staff, Veterinary 20737–1228. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17091 conducted in a laboratory located in the must be moved and handled as to section 306 of the Act of June 17, country of origin, and the laboratory specified on the permit to prevent the 1930, as amended (19 U.S.C. 1306), was approved to conduct the tests by introduction of VVND or S. enteritidis, unless they are exported by the the national government of that country. phage-type 4, into the United States. consignee within 8 hours on the same (2) Beginning the week after the flock (4) Other. The eggs may be imported means of conveyance and meanwhile was tested and found negative as when the Administrator determines that are retained under such isolation and required in paragraph (d)(1)(x)(C)(1) of the eggs have been cooked or processed other safeguards as the Administrator this section, and continuing once a or will be handled in a manner that will may require to prevent the introduction week thereafter, a salaried veterinarian prevent the introduction of VVND or S. or dissemination of livestock or poultry of the national government of the enteritidis, phage-type 4, into the United diseases into the United States. country of origin collected 25 carcasses, States. The eggs must be accompanied (d) Fresh, chilled, or frozen meats, or 10 percent of the carcasses, by a permit obtained from APHIS prior prohibited importation under §§ 94.1 whichever was greater, of all the poultry to the importation in accordance with and 94.2, that come into the United that died in each house during the paragraph (e) of this section, and they States by any means but are not offered previous week. The carcasses were must be moved and handled as for entry into this country; and other bacteriologically examined and found specified on the permit to prevent the animals, meats, and other articles negative for S. enteritidis. The introduction of VVND or S. enteritidis, prohibited importation under other examinations were conducted in a phage-type 4, into the United States. sections of this part that come into the laboratory located in the country of (e) To apply for a permit, contact the United States by any means, whether origin, and the laboratory was approved Administrator, c/o National Center for they are offered for entry into this to conduct the examinations by the Import and Export, 4700 River Road, country or not, shall be immediately national government of that country. Unit 39, Riverdale, 20737–1231. detained, removed, destroyed or (3) After the blood specimens were (Approved by the Office of Management and otherwise disposed of as the drawn as required in paragraph Budget under control number 0579–0015) Administrator may direct at any time in (d)(1)(x)(C)(1) of this section, no poultry accordance with section 2 of the Act of were added to the flock of origin until § 94.8 Disposal of meats ineligible for importation. February 2, 1903, as amended, or a blood specimen from each was tested section 2 of the Act of July 2, 1962 (21 (a) Fresh, chilled, or frozen meats, for S. enteritidis with Salmonella U.S.C. 111, 134a). pullorum or S. enteritidis antigen using prohibited importation under §§ 94.1 a plate or tube test, and the specimen and 94.2, that come into the United § 94.9 Meat and other animal products; in- was found negative. The tests were States by ocean vessel and are offered transit movement and handling. conducted in a laboratory located in the for entry and refused admission into (a) Any meat or other animal product country of origin, and the laboratory this country, shall be destroyed or that would be eligible for entry into the was approved to conduct the tests by otherwise disposed of as the United States, as specified in the the national government of that country. Administrator may direct pursuant to regulations in this part, may transit (2) To an approved establishment for section 306 of the Act of June 17, 1930, through the United States for immediate breaking and pasteurization. The eggs as amended (19 U.S.C. 1306), unless export if the following conditions are may be imported if they are moved from they are exported by the consignee met: the port of arrival in the United States, within 48 hours, and meanwhile are (1) Notification of the transiting of under seal of the United States retained under such isolation and other such meat or other animal product is Department of Agriculture, to an safeguards as the Administrator may made by the importer to the Plant approved establishment 15 for breaking require to prevent the introduction or Protection and Quarantine Officer at the and pasteurization. Establishments will dissemination of livestock or poultry United States port of arrival prior to be approved when the Administrator diseases into the United States. such transiting; and determines that pasteurization and (b) Fresh, chilled, or frozen meats (2) The meat or other animal product sanitation procedures for handling the prohibited importation under §§ 94.1 transited is contained in a sealed, eggs, and for disposing of egg shells, and 94.2, that come into the United leakproof carrier or container that must cases, and packing materials, are States aboard an airplane or railroad car remain sealed while aboard the adequate to prevent the introduction of and are refused entry into this country, transporting carrier or other means of VVND or S. enteritidis, phage-type 4, shall be destroyed or otherwise conveyance, or if the container or carrier into the United States. disposed of as the Administrator may in which the meat or other animal (3) For scientific, educational, or direct pursuant to section 306 of the Act product is transported is offloaded in research purposes. The eggs may be of June 17, 1930, as amended (19 U.S.C. the United States for reshipment, it imported if they are imported for 1306), unless they are exported by the must remain sealed at all times. scientific, educational, or research consignee within 24 hours, and (b) Meat or other animal products that purposes and the Administrator has meanwhile are retained under such are not otherwise eligible for entry into determined that the importation can be isolation and other safeguards as the the United States in accordance with the made under conditions that will prevent Administrator may require to prevent regulations in this part may enter the the introduction of VVND or S. the introduction or dissemination of United States through land border ports enteritidis, phage-type 4, into the United livestock or poultry diseases into the for transit through the United States and States. The eggs must be accompanied United States. immediate export if the following by a permit obtained from APHIS prior (c) Fresh, chilled, or frozen meats conditions are met: to the importation in accordance with prohibited importation under §§ 94.1 (1) The person desiring to move the paragraph (e) of this section, and they and 94.2 that come into the United meat or other animal products through States by any means other than ocean the United States obtains a United 15 The names and addresses of approved vessel, airplane, or railroad car and are States Veterinary Permit for Importation establishments may be obtained from, and requests refused entry into this country, shall be and Transportation of Controlled for approval may be made to National Center for Import and Export, 4700 River Road Unit 39, destroyed or otherwise disposed of as Materials and Organisms and Vectors Riverdale, MD 20737–1231. the Administrator may direct pursuant (VS Form 16–6). (An application for the 17092 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules permit may be obtained from the carrier or other means of conveyance, in a manner approved by the Animal and Plant Health Inspection or, if the container or carrier in which Administrator as adequate to prevent Service, Veterinary Services, National the meat or other animal product is the introduction or dissemination of Center for Import-Export, 4700 River transported is offloaded in the United livestock diseases into the United Road Unit 38, Riverdale, Maryland States for reshipment, it remains sealed States. However, in specific cases, upon 20737–1231.) at all times; request by the importer to the (2) The meat or other animal products (3) Such transit is limited to the Administrator, and with approval by the are sealed in the region of origin in a maritime or airport port of arrival only, Administrator, they may be stored for a leakproof container with serially with no overland movement outside the temporary period in an approved numbered seals approved by APHIS, airport terminal area or dock area of the warehouse 16 under the supervision of and the container remains sealed during maritime port; and an APHIS inspector pending movement the entire time that it is in transit across (4) The meat or other animal product to an approved establishment. Such the United States, from the point of is not held or stored for more than 24 products must be transported from the arrival to its exportation. hours at the maritime or airport port of United States port of first arrival to an (3) The person moving the meat or arrival. approved establishment or an approved other animal products through the warehouse, and from an approved § 94.10 Milk and milk products. United States notifies, in writing, the warehouse to an approved Plant Protection and Quarantine Officer (a) The following milk products are establishment only under Department at the United States port of arrival prior exempt from the provisions of this part: seals or seals of the U.S. Customs to such transiting. The notification must (1) Cheese, but not including cheese Service. Such seals may be broken only include the following information with liquid and not including cheese by such an inspector or other person regarding the meat or other animal made with unpasteurized milk, and not authorized to do so by the products: including cheese containing any item Administrator. Such products may not (i) Permit number; that is regulated by other sections of this be removed from the approved (ii) Times and dates of arrival in the part, unless such item is independently warehouse or approved establishment United States; eligible for importation into the United except upon special permission by the (iii) Time schedule and route to be States under this part; Administrator, and upon compliance followed through the United States; and (2) Butter; and with all the conditions and (iv) Serial numbers of the seals on the (3) Butteroil. requirements specified by him or her for containers. (b) Milk and milk products originating such movement in each specific case. (4) The meat and other animal in, or shipped from, any region products transit the United States under classified as Risk Class R3, R4 or RU for (3) Milk and milk products not Customs bond and are exported from rinderpest or foot-and-mouth disease exempted under paragraph (a) of this the United States within the time limit may be imported into the United States section and not of classes included specified on the permit. Any meat and if they are certified as having met the within the provisions of paragraphs (b) other animal products that have not requirements of paragraphs (b) (1), (2), (1) or (2) of this section may be been exported within the time limit or (3) of this section: imported if the importer first applies to specified on the permit or that have not (1) They are in a concentrated liquid and receives written permission from been transited in accordance with the form and have been processed by heat the Administrator authorizing such permit or applicable requirements of by a commercial method in a container importation. Permission will be granted this part will be destroyed or otherwise hermetically sealed promptly after only when the Administrator disposed of as the Administrator may filling but before such heating, so as to determines that such action will not direct pursuant to section 2 of the Act be shelf stable without refrigeration. endanger the health of the livestock of of February 2, 1903, as amended (21 (2) They are dry milk or dry milk the United States. Products subject to U.S.C. 111). products, including dry whole milk, this provision include but are not (c) Meat and other animal products nonfat dry milk, dried whey, dried limited to condensed milk, long-life from regions listed as R1 or R2 regions buttermilk, and formulations that milks such as sterilized milk, casein and for restricted agents of ruminants or contain any such dry milk products, and caseinates, lactose, and lactalbumin. swine, that are not otherwise eligible for are consigned directly to an approved (4) Small amounts of milk and milk importation, may transit the United establishment 16 for further processing products subject to the restrictions of States for immediate export, provided this part may in specific cases be the requirements of paragraph (a) of this 16 The names and addresses of approved imported for purposes of examination, section are met. establishments or warehouses or information as to testing, or analysis, if the importer (d) Any meat or other animal products approved manner of processing, and request for applies to and receives written approval approval of any such establishment, warehouse, or not otherwise eligible for entry into the manner of processing may be made to the National for such importation from the United States, as provided in this part Center for Import and Export Unit 40, 4700 River Administrator. Approval will be granted and part 95 of this chapter, may transit Road, Riverdale, MD 20737–1231. Any only when the Administrator the United States for immediate export establishment or warehouse will be approved for determines that such action will not the purpose of this section only if the operator has if the following conditions are met: provided the Administrator with satisfactory (1) Notification of the transiting of evidence that the establishment or warehouse has by the Administrator only after the operator thereof such meat or other animal product is the equipment, facilities, and capability to store, has been given notice of the proposed action and made by the importer to the Plant handle and process the imported dry milk or dry has had an opportunity to present his views milk product subject to § 94.9(b)(2) in a manner thereon, and upon a determination by the Protection and Quarantine officer at the which will prevent the introduction or Administrator that the conditions for approval are United States port of arrival prior to dissemination of livestock diseases into the United not met. Approval of an establishment or such transiting; States. Similarly, processing methods will be warehouse may also be withdrawn after such notice (2) The meat or other animal product approved only if the Administrator determines they and opportunity if the Administrator determines are adequate to prevent the introduction or that such imported dry milk or milk products have is contained in a sealed, leakproof dissemination of such diseases into the United been stored, handled, or processed by the operator carrier or container, which remains States. Approval of any establishment or warehouse thereof other than at an approved establishment or sealed while aboard the transporting or processing method may be refused or withdrawn warehouse or other than in an approved manner. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17093 endanger the health of the livestock of ruminants may be imported into the § 94.11 Dry-cured pork products from the United States. United States if accompanied by regions classified as Risk Class R3, R4, or (c) Milk and milk products originating documentation indicating the region of RU for foot-and-mouth disease, rinderpest, in and shipped from regions that are African swine fever, hog cholera, or swine origin of the milk or milk product, and vesicular disease. classified as Risk Class RN, R1, or R2 for if they are not otherwise prohibited A dry-cured ham, pork shoulder, or rinderpest and foot-and-mouth disease, importation under paragraph (c) of this pork loin shall not be permitted but that have entered a port or otherwise section. transited any region that is classified as importation into the United States from Risk Class R3, R4 or RU for rinderpest (e) Milk or milk products imported a region that is classified as Risk Class or foot-and-mouth disease shall not be from a region classified as R1 or R2 for R3, R4, or RU for foot-and-mouth imported into the United States unless: rinderpest and foot-and-mouth disease disease, rinderpest, African swine fever, (1) The product was transported must be accompanied by a certificate hog cholera, or swine vesicular disease under serially numbered official seals endorsed by a full-time, salaried unless it meets the following conditions: applied at the point of origin of the veterinarian employed by the country of (a) The ham, pork shoulder, or pork shipment by an authorized export. The certificate must state that loin came from a region determined by representative of the country of such the milk was produced and processed in the Administrator to have and to enforce origin; except that, if any seal applied at a region that is classified as RN, R1 or laws requiring the immediate reporting the point of origin was broken by any R2 for rinderpest and foot-and-mouth to the national veterinary services of foreign official to inspect the shipment, disease, or that the milk product was that region any premises found to have an authorized representative of that processed in a foreign region that is any animal infected with foot-and- country applied a new serially classified as RN, R1, or R2 for rinderpest mouth disease, rinderpest, African numbered official seal to the hold, and foot-and-mouth disease, from milk swine fever, hog cholera, or swine compartment, or container in which the produced in a region classified as RN, vesicular disease; milk or milk products were transported; R1, or R2 for rinderpest and foot-and- (b) The ham, pork shoulder, or pork and if any member of a ship’s crew mouth disease. The certificate must loin came from a swine that was not on broke a seal, the serial number of the name the region in which the milk was any premises where foot-and-mouth seal, the location of the seal, and the produced and the foreign region in disease, rinderpest, African swine fever, reason for breaking the seal were which the milk or milk product was hog cholera, or swine vesicular disease recorded in the ship’s log. processed. Further, the certificate must exists or had existed within 60 days (2) The numbers of such seals are state that, except for movement under prior to slaughter; listed on, or are on a list attached to, the (c) The ham, pork shoulder, or pork seal as described in § 94.10(c), the milk bill of lading or similar document loin was accompanied from the or milk product has never been in a accompanying the shipment. slaughtering facility to the processing region that is classified as R3, R4, or RU (3) Upon arrival of the carrier at the establishment by a numbered certificate for rinderpest or foot-and-mouth first United States port, an APHIS issued by a person authorized by the disease. Milk or milk products from a inspector determines that the seals are government of the country of origin intact and that their numbers are in region that is classified as RN, R1, or R2 stating that the provisions of paragraph agreement with the numbers appearing for rinderpest and foot-and-mouth (b) of this section have been met; on the accompanying document; disease, that were processed in whole or (d) The ham, pork shoulder, or pork Provided that, if the representative finds in part from milk or milk products from loin was processed as set forth in that any seal has been broken or has a a foreign region classified as R3, R4, or paragraph (h) of this section in only one different number than is recorded on the RU, may be imported into the United processing establishment; 17 accompanying document, the milk or States in accordance with § 94.10(b)(3). (e) The ham, pork shoulder, or pork milk products may remain eligible for (f) Milk or milk products from regions loin was processed in a processing entry into the United States only if listed that are classified as Risk Class establishment that, prior to the APHIS personnel are available to R3, R4 or RU for Brucella melitensis processing of any hams, pork shoulders, inspect the hold, compartment, or shall enter the United States only under or pork loins in accordance with this container, the cartons or other the following conditions: section, was inspected by a veterinarian containers of milk or milk products, and of APHIS and determined by the (1) The milk must be pasteurized all accompanying documentation; and Administrator to be capable of meeting according to the Food and Drug also provided that the representative the provisions of this section for Administration requirements of 21 CFR determines that such products meet all processing hams, pork shoulders, or 131.3; of the importation requirements, and the pork loins for importation into the importer furnishes additional (2) Milk and milk products, including United States; documentation (either copies of pages cheese, must meet the Food and Drug (f) The ham, pork shoulder, or pork from the ship’s log signed by the officer- Administration requirements of 21 CFR loin was processed in a processing in-charge, or certification from a foreign part 1210 and any other applicable establishment for which the operator of government that the original seal was regulations for imported milk; the establishment has signed an removed and the new seal applied by (3) Milk products, including cheese, agreement with APHIS within 12 officials of the government) that must be prepared from milk treated as months prior to receipt of the hams, demonstrates to the satisfaction of the described in paragraph (f)(1) of this pork shoulders, or pork loins for Administrator that the milk or milk section before being used to processing, stating that all hams, pork products were not contaminated or manufacture milk products; and exposed to contamination during 17 As a condition of entry into the United States, movement from the region of origin to (4) Milk or milk products must be pork and pork products must also meet all of the the United States. processed in a facility where only milk requirements of the Federal Meat Inspection Act (21 or milk products are processed as U.S.C. 601 et seq.) and the regulations thereunder (d) Milk and milk products from (9 CFR part 301), including requirements that the regions that are classified as Risk Class described in paragraph (f)(1) of this pork or pork products be prepared only in approved RN for disease agents affecting section. establishments. 17094 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules shoulders, or pork loins processed for chamber maintained at a temperature of must be maintained at that level an importation into the United States will 1 to 6 °C. (33.8 to 42.8 °F.) and at a additional 370 days, until at least 560 be processed only in accordance with relative humidity of 65–80 percent for days after the start of the curing process. the provisions of this part; between 52 and 72 days; thereafter the (3) Iberian hams. Iberian hams were (g) Workers who handle fresh pork in ham was brushed and rinsed with processed as follows (365-day minimum the processing establishment where the water; thereafter the ham was placed in curing process): dry-cured ham, pork shoulder, or pork a chamber for 5–7 days at a temperature (i) If the ham was received frozen, it loin was processed are required to of 15 to 23 °C. (59 to 73.4 °F.) and a was thawed in a chamber with relative shower and put on a full set of clean relative humidity of 55–85 percent; humidity between 70 and 80 percent, clothes, or to wait 24 hours after thereafter the ham was placed for curing with room temperature maintained at handling fresh pork, before handling in a chamber maintained for a minimum 5.5 to 6.5 °C. (41.9 to 43.7 °F.) for the hams, pork shoulders, or pork loins that of 314 days at a temperature of 15 to 20 first 24 hours, then at 9.5 to 10.5 °C. have progressed in the aging/curing °C. (59 to 68 °F.) and at a relative (49.1 to 50.9 °F.) until the internal process as follows: humidity of 65–80 percent at the temperature of the ham reached 3 to 4 (1) In the case of Italian-type hams beginning and increased by 5 percent °C. (37.4 to 39.2 °F.), at which point the processed in accordance with paragraph every 21⁄2 months until a relative blood vessels at the end of the femur (h)(1) of this section, those that have humidity of 85 percent was reached. were massaged to remove any remaining progressed beyond the final wash stage; (2) Serrano hams. Serrano hams were blood. (2) In the case of Serrano hams or processed as follows (190-day minimum (ii) The ham was covered in salt and Iberian hams or pork shoulders curing process): placed in a chamber maintained at a processed in accordance with (i) If the ham is received frozen, it was temperature from 0 to 4 °C. (32 to 39.2 paragraphs (h)(2), (h)(3), or (h)(4) of this thawed in a chamber with relative °F.), with relative humidity between 75 section, those that have progressed humidity between 70 and 80 percent, and 95 percent, and kept in the chamber beyond salting; and with room temperature maintained at 12 for a period no less than 0.65 days per (3) In the case of Iberian pork loins to 13 °C. (53.6 to 55.4 °F.) for the first kg., and no more than 2 days per kg., of processed in accordance with paragraph 24 hours, then at 13 to 14 °C. (55.4 to the weight of the ham. (h)(5) of this section, those that have 57.2 °F.) until the internal temperature (iii) The ham was rinsed with water progressed beyond being placed in a of the ham reached 3 to 4 °C. (37.4 to and/or brushed to remove any casing; and 39.2 °F.), at which point the blood remaining surface salt. (h) The dry-cured ham, pork shoulder, vessels at the end of the femur were (iv) The ham was placed in a chamber or pork loin was processed in ° massaged to remove any remaining maintained at a temperature of 0 to 6 C. accordance with this paragraph. Except (32 to 42.8 °F.), with relative humidity ° blood. for pork fat treated to at least 76 C. of 70 to 95 percent, for no less than 40 ° (ii) The ham was covered in salt and (168.8 F.), which may have been placed placed in a chamber maintained at a and no more than 60 days. over the meat during curing, the dry- temperature from 0 to 4 °C. (32 to 39.2 (v) The ham was placed for curing in cured pork product must have had no °F.), with relative humidity between 75 a chamber with a temperature of 6 to 16 contact with any other meat or animal ° ° and 95 percent, for a period no less than C. (42.8 to 60.8 F.) and relative product during processing: 0.65 days per kg., and no more than 2 humidity of 60 to 80 percent for a (1) Italian-type hams. The ham was minimum of 90 days. processed for a period of not less than days per kg., of the weight of the ham. (iii) The ham was rinsed with water (vi) The temperature was raised to 16 400 days in accordance with the ° ° and/or brushed to remove any to 26 C. (60.8 to 78.8 F.) and the following conditions: after slaughter the remaining surface salt. relative humidity reduced to 55 to 85 ham was held at a temperature of 0 to percent, for a minimum of 90 days. ° ° (iv) The ham was placed in a chamber 3 C. (3 to 34.7 F.) for a minimum of maintained at a temperature of 0 to 6 °C. (vii) Finally, with the relative 72 hours, during which time the ‘‘aitch’’ (32 to 42.8 °F.), with a relative humidity humidity raised to 60 to 90 percent, the ° bone and the foot was removed and the of 70 to 95 percent, for no less than 40 temperature was lowered to 12 to 22 C. ° blood vessels at the end of the femur and no more than 60 days. (53.6 to 71.6 F.) and maintained at that were massaged to remove any remaining (v) The ham was placed for curing in level for a minimum of 115 days, until blood; thereafter the ham was covered a chamber with a relative humidity of at least 365 days after the start of the with an amount of salt equal to 4 to 6 60 to 80 percent and a temperature curing process; Except that: In a region percent of the weight of the ham, with gradually raised in 3 phases, as follows: that is classified as R3, R4, or RU for a sufficient amount of water added to (A) A temperature of 6 to 16 °C. (42.8 swine vesicular disease, the ham must ensure that the salt had adhered to the to 60.8 °F.), maintained for a minimum be maintained at that level an additional ham; thereafter the ham was placed for of 45 days; 195 days, until at least 560 days after 5 to 7 days on racks in a chamber (B) A temperature of 16 to 24 °C. (60.8 the start of the curing process. maintained at a temperature of 0 to 4 °C. to 75.2 °F.), maintained for a minimum (4) Iberian pork shoulders. Iberian (32 to 39.2 °F.) and at a relative of 35 days; and pork shoulders were processed as humidity of 70 to 85 percent; thereafter (C) A temperature of 24 to 34 °C. (75.2 follows (240-day minimum curing the ham was covered with an amount of to 93.2 °F.), maintained for a minimum process): salt equal to 4 to 6 percent of the weight of 30 days. (i) If the pork shoulder was received of the ham, with a sufficient amount of (vi) Finally, with the relative frozen, it was thawed at a room water added to ensure that the salt had humidity unchanged at 60 to 80 percent, temperature of 12 to 13 °C. (53.6 to 55.4 adhered to the ham; thereafter the ham the temperature was lowered to 12 to 20 °F.), with the relative humidity between was placed for 21 days in a chamber °C. (53.6 to 68 °F.) and maintained at 75 and 85 percent, for approximately 24 maintained at a temperature of 0 to 4 °C. that level for a minimum of 35 days, hours, until the internal temperature (32 to 39.2 °F.) and at a relative until at least 190 days after the start of reached 3 to 4 °C. (37.4 to 39.2 °F.), at humidity of 70 to 85 percent; thereafter the curing process; Except that: In a which point the blood vessels in the the salt was brushed off the ham; region that is classified as R3, R4, or RU scapular region were massaged to thereafter the ham was placed in a for swine vesicular disease, the ham remove any remaining blood. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17095

(ii) The pork shoulder was covered in (B) A temperature of 6 to 15 °C. (42.8 establishment under the direct salt and placed in a chamber maintained to 59.0 °F.), maintained for a minimum supervision of a person authorized to at a temperature of 0 to 4 °C. (32 to 39.2 of 20 days; supervise such activity by the veterinary °F.) with the relative humidity between (C) A temperature of 15 to 25 °C. (59.0 services of the national government of 75 and 95 percent, for a period of no to 77.0 °F), maintained for a minimum the country of origin, and bears a less than 0.65 days per kg., and no more of 40 days; tamper-proof plastic tag, securely than 2 days per kg., of the weight of the (v) Finally, with the relative humidity attached to the pork loin itself, that pork shoulder. unchanged at 60 to 80 percent and the states the identifying number of the ° (iii) The pork shoulder was rinsed temperature lowered to 0 to 5 C. (32.0 slaughtering establishment and the date ° with water and/or brushed to remove to 41.0 F.), the pork loin was vacuum- the pork loin was placed in the pickle any remaining surface salt. packed and maintained under those preparation under the supervision of a (iv) The pork shoulder was placed in conditions for a minimum of 15 days, person authorized to supervise such a chamber maintained at a temperature until at least 130 days after the start of activity by the veterinary service of the of 0 to 6 °C. (32 to 42.8 °F.) and a the curing process. national government of the country of relative humidity of 70 to 95 percent for (i)(1) The ham, if it is Italian-type ham origin. not less than 40 days and not more than processed in accordance with paragraph (j) The dry-cured ham, pork shoulder, 60 days. (h)(1) of this section, bears a hot iron or pork loin came from an establishment (v) The pork shoulder was placed for brand or an ink seal (with the where a person authorized by the identifying number of the slaughtering curing in a chamber at a temperature of veterinary services of the national establishment) that was placed thereon 6 to 16 °C. (42.8 to 60.8 °F.) and a government of the country of origin to at the slaughtering establishment under relative humidity of 60 to 80 percent for conduct activities under this paragraph the direct supervision of a person a minimum of 90 days. maintained original records (which authorized to supervise such activity by (vi) The temperature was raised to 16 shall be kept for a minimum of 2 years) the veterinary services of the national to 26 °C. (60.8 to 78.8 °F.) and the identifying the dry-cured ham, pork government of the country in which the relative humidity was changed to 55 to shoulder, or pork loin by the date it region of origin is located bears a button 85 percent, and those levels were entered the processing establishment, by seal (approved by the Administrator as the slaughtering facility from which it maintained for a minimum of 90 days. being tamper-proof) on the hock that (vii) Finally, the temperature was came, and by the number of the states the month and year the ham certificate that accompanied the dry- reduced to 12 to 22 °C. (53.6 to 71.6 °F.) entered the processing establishment cured ham, pork shoulder, or pork loin and the relative humidity was raised to and a hot iron brand (with the from the slaughtering facility to the 60 to 90 percent for a minimum of 45 identifying number of the processing processing establishment, and where days, until at least 240 days after the establishment and the date salting such original records are maintained start of the curing process. began) that were placed thereon at the under lock and key by such person, (5) Iberian pork loins. Iberian pork processing establishment immediately with access to such original records loins were processed as follows (130- prior to salting, under the supervision of restricted to officials of the government day minimum curing process): a person authorized to supervise such of the country of origin, officials of the (i) If the pork loin was received activity by the veterinary services of the United States government, and such frozen, it was thawed at a room national government of the country of ° person maintaining the records. temperature maintained at 11 to 12 C. origin; ° (k) The dry-cured ham, pork shoulder, (51.8 to 53.6 F.), with the relative (2) The dry-cured ham, if it is or pork loin came from a processing humidity between 70 and 80 percent for processed in accordance with establishment that allows the the first 24 hours, then between 75 and paragraphs (h)(2) or (h)(3) of this unannounced entry into the 85 percent, until the loin’s internal section, or the dry-cured pork shoulder, establishment of APHIS personnel, or ° temperature reached 3 to 4 C. (37.4 to if it is processed in accordance with other persons authorized by the ° 39.2 F.), at which point the external fat, paragraph (h)(4) of this section, bears an Administrator, for the purpose of aponeurosis, and tendons were cleaned ink seal (with the identifying number of inspecting the establishment and from the loin. the slaughtering establishment) that was records of the establishment. (ii) The pork loin was covered in a placed thereon at the slaughtering (l) The dry-cured ham, pork shoulder, pickle preparation (25–30 grams of salt establishment under the direct or pork loin was processed in for each kilogram of pork loin) and supervision of a person authorized to accordance with one of the following placed in a chamber where it was supervise such activity by the veterinary criteria: maintained at a relative humidity of 75 services of the national government of (1) The ham, if it is an Italian-type to 95 percent and a temperature of 3 to the country of origin, and an ink seal ham processed in accordance with 4 °C. (37.4 to 39.2 °F.) for 72 hours. (with the identifying number of the paragraph (h)(1) of this section, was (iii) The pork loin was removed from processing establishment and the date processed in a region that is classified the pickle preparation (25–30 grams of the salting began) that was placed as either an RN, R1, or R2 region for salt for each kilogram of pork loin), thereon at the processing establishment, rinderpest, and which has, through the externally cleaned (brushed or rinsed), immediately prior to salting, under the veterinary services of the country in placed in an artificial casing, and supervision of a person authorized to which it is located, submitted to the fastened shut with a metal clip. supervise such activity by the veterinary Administrator a written statement (iv) The pork loin was placed for services of the national government of stating that it conducts a program to curing in a chamber with a relative the country of origin; or authorize persons to supervise activities humidity of 60 to 90 percent and a (3) The dry-cured pork loin, if it is specified under this section; temperature gradually raised in 3 processed in accordance with paragraph (2) The Serrano ham, processed in phases, as follows: (h)(5) of this section, is packaged with accordance with paragraph (h)(2) of this (A) A temperature of 2 to 6 °C. (35.6 material that bears a seal of the section, and came from any breed of to 42.8 °F.), maintained for a minimum government of the country of origin that large, white swine, including but not of 20 days; was placed thereon at the slaughtering limited to Landrace, Pietrain, Duroc, 17096 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

Jersey, Hampshire, and Yorkshire (ii) Is a Serrano ham processed under and Organisms and Vectors by filing a breeds, and crosses of such breeds; paragraph (h)(2) of this section, it was: permit application on VS form 16–3.18 (3) The Iberian ham, processed in (A) Processed for a minimum of 190 (3) The permit application must state accordance with paragraph (h)(3) of this days in a region that is classified as the intended use of the gelatin and the section, and came from a swine of the either RN, R1, or R2 for swine vesicular name and address of the consignee in Iberico breed of pigs; disease, in a facility authorized by the the United States. (4) The Iberian pork shoulder, veterinary services of the national (b) Transit shipment of articles. Fresh, processed in accordance with paragraph government of the country in which the chilled, or frozen meat, and edible (h)(4) of this section, and came from a region of origin is located to process products other than meat, that are swine of the Iberico breed of pigs; meat only from regions classified as prohibited importation into the United (5) The Iberian pork loin, if processed either RN, R1, or R2 for swine vesicular States from regions that are classified as in accordance with paragraph (h)(5) of disease; or Risk Class R3, R4 or RU for bovine this section, and came from a swine of (B) Processed for a minimum of 560 spongiform encephalopathy may transit the Iberico breed of pigs. days in any region, in a facility that may the United States for immediate export (m) The dry-cured ham, pork also process meat from regions that are if the following conditions are met: shoulder, or pork loin came from a classified as R3, R4, or RU for swine (1) The person moving the articles processing establishment that has vesicular disease; obtains a United States Veterinary entered into a trust fund agreement (iii) Is an Iberian ham processed Permit for Importation and executed by the operator of the under paragraph (h)(3) of this section, it Transportation of Controlled Materials establishment or a representative of the was: and Organisms and Vectors by filing a establishment and APHIS, and that (A) Processed for a minimum of 365 permit application on VS form 16–3. pursuant to the trust fund agreement is days in a region that is classified as RN, (2) The articles are sealed in leakproof current in paying all costs for a R1, or R2 for swine vesicular disease, in containers bearing serial numbers veterinarian of APHIS to inspect the a facility authorized by the veterinary during transit. Each container must establishment (it is anticipated that such services of the national government of remain sealed during the entire time inspections will occur up to four times the country in which the region is that it is in the United States. per year), including travel, salary, located to process only meat from (3) The person moving the articles subsistence, administrative overhead, countries that are classified as RN, R1, notifies, in writing, the Plant Protection and other incidental expenses or R2 for swine vesicular disease; or and Quarantine Officer at both the place (including an excess baggage provision (B) Processed for a minimum of 560 in the United States where the articles up to 150 pounds). In accordance with days in any region, in a facility that may will arrive and the port of export prior the terms of the trust fund agreement, also process meat from regions that are to such transit. The notification must the operator of the processing classified as R3, R4, or RU for swine include the: establishment must deposit with the vesicular disease; (i) United States Veterinary Permit for Administrator an amount equal to the (iv) Is a dry-cured pork shoulder, it Importation and Transportation of approximate costs for a veterinarian to was processed in accordance with Controlled Materials and Organisms and inspect the establishment one time, paragraph (h)(4) of this section for a Vectors permit number; including travel, salary, subsistence, minimum of 240 days; or (ii) Times and dates of arrival in the administrative overhead and other (v) Is a dry-cured pork loin, it was United States; incidental expenses (including an processed in accordance with paragraph (iii) Times and dates of exportation excess baggage provision up to 150 (h)(5) of this section for a minimum of from the United States; (iv) Mode of transportation; and pounds), and as funds from that amount 130 days. (v) Serial numbers of the sealed are obligated, bills for costs incurred (Approved by the Office of Management and containers. based on official accounting records will Budget under control number 0579–0015) (4) The articles transit the United be issued to restore the deposit to its States in Customs bond. original level. Amounts to restore the § 94.12 Ruminant meat and edible deposit to its original level must be paid products from ruminants that have been in (Approved by the Office of Management and regions classified as Risk Class R3, R4, or Budget under control number 0579–0015) within 14 days of receipt of such bills. RU for bovine spongiform encephalopathy. (n) The dry-cured ham, pork shoulder, § 94.13 Movement of meat and meat or pork loin is accompanied at the time (a) Gelatin. The importation of gelatin products. derived from ruminants that have been of importation into the United States by Meat or meat products consigned a certificate issued by a person in any region that is classified as Risk Class R3, R4 or RU for bovine from the port of arrival to an approved authorized to issue such certificates by establishment under the provisions of the veterinary services of the national spongiform encephalopathy is prohibited unless the following this part (e.g., § 94.5 (f) and (i)) must be government of the country of origin, moved from the port of arrival to the stating: conditions have been met: (1) The gelatin must be imported for approved establishment under Customs (1) That all the provisions of this seals or seals of the Administrator, and section have been complied with, use in human food, human pharmaceutical products, photography, must be otherwise handled as the including paragraphs (h) and (l) of this Administrator may direct in order to section; and or some other use that will not result in the gelatin coming in contact with guard against the introduction and (2) The paragraph of this section dissemination of contagious diseases of under which the dry-cured ham, pork ruminants in the United States. (2) The person importing the gelatin livestock. Seals applied under this shoulder, or pork loin was processed; section may not be broken except by and stating further that, if the product must obtain a United States Veterinary Permit for Importation and persons authorized to do so by the covered by the certificate: Administrator. (i) Is an Italian-type ham processed Transportation of Controlled Materials under paragraph (h)(1) of this section, it 18 VS form 16–3 may be obtained from National was processed for a minimum of 400 Center for Import and Export, 4700 River Road Unit days; 40, Riverdale, MD 20737–1231. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17097

§ 94.14 Seizure, quarantine, and disposal 95.7 Wool, hair, and bristles; requirements Animal byproducts. Hides, skins, hair, of meat and meat products. for unrestricted entry. wool, glue stock, bones, hoofs, horns, Meat or meat products imported into 95.8 Wool, hair, and bristles; importations bone meal, hoof meal, horn meal, blood the United States from a region that is permitted subject to restrictions. meal, meat meal, tankage, glands, classified as Risk Class R3, R4, or RU for 95.9 Glue stock; requirements for unrestricted entry. organs, or other parts or products of foot-and-mouth disease, rinderpest, 95.10 Glue stock; importations permitted ruminants and swine unsuitable for African swine fever, bovine spongiform subject to restrictions. human consumption. encephalopathy, hog cholera, and/or 95.11 Bones, horns, and hoofs for trophies Approved chlorinating equipment. swine vesicular disease that do not meet or museum; disinfected hoofs. Equipment approved by the the requirements specified in this part 95.12 Bones, horns, and hoofs; importations Administrator as effective for the shall be seized, quarantined, and permitted subject to restrictions. disinfection of effluents against the disposed of as the Administrator may 95.13 Bone meal for use as fertilizer or as contagions of foot-and-mouth disease, direct in order to guard against the feed for domestic animals; requirements rinderpest, lumpy skin disease introduction and dissemination of the for entry. (Neethling virus), Sheep pox, goat pox, 95.14 Blood meal, tankage, meat meal, and contagion of the disease. similar products, for use as fertilizer or African swine fever, hog cholera, and animal feed; requirements for entry. swine vesicular disease. § 94.15 Cancellation of compliance Approved establishment. An agreements. 95.15 Blood meal, blood albumin, intestines, and other animal byproducts establishment approved by the Any compliance agreement may be for industrial use; requirements for Administrator for the receipt and canceled orally or in writing by the unrestricted entry. handling of restricted import animal inspector who is supervising its 95.16 Blood meal, blood albumin, byproducts. enforcement whenever the inspector intestines, and other animal byproducts Approved sewerage system. A finds that such person has failed to for industrial use; importations drainage system equipped and operated comply with the provisions of this permitted subject to restrictions. so as to carry and dispose of sewage section or any conditions imposed 95.17 Glands, organs, ox gall, and like materials; requirements for unrestricted without endangering livestock through pursuant to such provisions. If the the contamination of streams or fields cancellation is oral, the decision and the entry. 95.18 Glands, organs, ox gall, and like and approved by the Administrator. reasons therefor shall be confirmed in materials; importations permitted subject Approved warehouse. A warehouse writing, as promptly as circumstances to restrictions. having facilities approved by the allow. Any person whose compliance 95.19 Animal stomachs. Administrator for the handling and agreement has been canceled may 95.20 Animal manure. storage, apart from other merchandise, appeal the decision, in writing, within 95.21 Hay and straw; requirements for of restricted import products. ten (10) days after receiving written unrestricted entry. Blood meal. Dried blood of animals. notification of the cancellation. The 95.22 Hay and straw; importations Bone meal. Ground animal bones and appeal shall state all of the facts and permitted subject to restrictions. hoof meal and horn meal. reasons upon which the person relies to 95.23 Previously used meat covers; importations permitted subject to Department. The United States show that the compliance agreement restrictions. Department of Agriculture. was wrongfully canceled. The 95.24 Methods for disinfection of hides, Glue stock. Fleshings, hide cuttings Administrator shall grant or deny the skins, and other materials. and parings, tendons, or other appeal, in writing, stating the reasons 95.25 Transportation of restricted import collagenous parts of animal carcasses. for such decision, as promptly as products; placarding cars and marking Hay and straw. Dried grasses, clovers, circumstances allow. If there is a billing; unloading enroute. legumes, and similar materials or stalks conflict as to any material fact, a hearing 95.26 Railroad cars, trucks, boats, aircraft or stems of various grains, such as shall be held to resolve such conflict. and other means of conveyance, barley, oats, rice, rye, and wheat. Rules of practice concerning such a equipment or containers, yards, and Inspector. An employee of the Animal premises; cleaning and disinfection. and Plant Health Inspection Service hearing will be adopted by the 95.27 Regulations applicable to products Administrator. from territorial possessions. authorized to perform duties required 52. Part 95 would be revised to read 95.28 Hay or straw and similar material under this part. as follows: from tick-infested regions. Meat meal or tankage. The rendered and dried carcasses or parts of the PART 95ÐSANITARY CONTROL OF Authority: 21 U.S.C. 111, 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.2(d). carcasses of animals. ANIMAL BYPRODUCTS (EXCEPT Region. Any defined geographic land CASINGS), AND HAY AND STRAW, § 95.1 Definitions. region identifiable by geological, OFFERED FOR ENTRY INTO THE political or surveyed boundaries. Whenever in the regulations in this UNITED STATES Risk Class Regions. Foreign exporting part the following words, names, or regions designated by APHIS according Sec. terms are used they shall be construed, to the results of a risk assessment as 95.1 Definitions. respectively, to mean: 95.2 Region of origin. defined in § 92.1 of this chapter, and 95.3 Prohibited animal byproducts. Administrator. The Administrator of determined by criteria as set forth in 95.4 Bone meal, blood meal, meat meal, the Animal and Plant Health Inspection § 92.3 of this chapter are incorporated offal, fat, glands, and serum from Service, or any other employee of the herein and are applicable to this part. ruminants in regions classified as Risk Animal and Plant Health Inspection Shipped directly. Shipped (moved, Class R3, R4, or RU for bovine Service, United States Department of transported, or otherwise shipped) spongiform encephalopathy according to Agriculture, delegated to act in the without unloading and without criteria in § 92.3 of this chapter. Administrator’s stead. 95.5 Untanned hides and skins; stopping except for refueling, or for requirements for unrestricted entry. Animal and Plant Health Inspection traffic conditions such as traffic lights or 95.6 Untanned hides and skins; Service. The Animal and Plant Health stop signs. importations permitted subject to Inspection Service of the United States United States. All of the States of the restrictions. Department of Agriculture (APHIS). United States, the District of Columbia, 17098 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

Guam, the Northern Mariana Islands, products, amniotic liquids or extracts, § 95.5 Untanned hides and skins; Puerto Rico, the Virgin Islands of the placental liquids or extracts, serum requirements for unrestricted entry. United States, and all other territories albumin, and serocolostrum, derived Untanned hides and/or skins of cattle, and possessions of the United States. from ruminants that have been in any buffalo, sheep, goats, other ruminants, region classified as Risk Class R3, R4, or and swine that do not meet the § 95.2 Region of origin. RU region bovine spongiform conditions of requirements specified in No products or materials specified in encephalopathy is prohibited unless the any one of paragraphs (a) to (e) of this the regulations in this part may be following conditions are met: section may not be imported except imported into the United States unless (1) The article is imported for use as subject to handling and treatment in there be shown upon the commercial an ingredient in cosmetics. accordance with § 95.6 after arrival at invoice, or in some other manner (2) The person importing the article the port of entry: satisfactory to the Administrator, the obtains a United States Veterinary (a) Hides or skins originating in and name of the region of origin of such Permit for Importation and shipped directly from a region classified product or material: Provided, That the Transportation of Controlled Materials as a Risk Class RN, R1, or R2 region for region of origin shall be construed to and Organisms and Vectors by filing a foot-and-mouth disease, rinderpest, mean: permit application on VS form 16–3.1 lumpy skin disease (Neethling virus), (a) In the case of an animal byproduct, (3) The permit application states the Sheep pox, goat pox, African swine the region in which such product was intended use of the article and the name fever, hog cholera, or swine vesicular taken from an animal or animals; and and address of the consignee in the disease may be imported without (b) In the case of other materials, the United States. further restriction. region in which such materials were (d) Transit shipment of articles. (b) Hides or skins may be imported produced. Articles that are prohibited importation without other restriction if found upon into the United States in accordance inspection by an inspector, or by § 95.3 Prohibited animal byproducts. with this section may transit the United certificate of the shipper or importer The importation of any animal States for immediate export if the satisfactory to said inspector, to be hard byproduct taken or removed from an following conditions are met: dried hides or skins. animal affected with anthrax, foot-and- (1) The person moving the articles (c) Abattoir hides or skins taken from mouth disease, rinderpest, bovine obtains a United States Veterinary animals slaughtered under national spongiform encephalopathy, Lumpy Permit for Importation and government inspection in a region 2 and skin disease (Neethling virus), Sheep Transportation of Controlled Materials in an abattoir in which is maintained an pox, goat pox, African swine fever, hog and Organisms and Vectors by filing a inspection service determined by the cholera, or swine vesicular disease is permit application on VS form 16–3.1 Administrator to be adequate to assure prohibited. (2) The articles must be sealed in that they have been removed from leakproof containers bearing serial § 95.4 Bone meal, blood meal, meat meal, animals found at time of slaughter to be offal, fat, glands, and serum from ruminants numbers during transit. Each container free from anthrax, foot-and-mouth in regions classified as Risk Class R3, R4 must remain sealed with a Customs seal disease, rinderpest, bovine spongiform or RU for bovine spongiform or seal of the Administrator during the encephalopathy, lumpy skin disease encephalopathy according to criteria in entire time that it is in the United States, (Neethling virus), Sheep pox, goat pox, § 92.3 of this chapter. and must be otherwise handled as the African swine fever, hog cholera, and (a) Except as provided in paragraphs Administrator may direct in order to swine vesicular disease, and to assure (c) and (d) of this section, the guard against the introduction and further the identity of such materials importation of bone meal, blood meal, dissemination of contagious diseases of until loaded upon the transporting meat meal or tankage, offal, fat, and livestock. vessel, may be imported into the United glands from ruminants that have been in (3) The person moving the articles States without other restriction if any region classified as a Risk Class R3, must notify, in writing, the Plant accompanied by a certificate bearing the R4, or RU region for bovine spongiform Protection and Quarantine Officer at seal of the proper department of such encephalopathy is prohibited. both the place in the United States national government and signed by an (b) Except as provided in paragraphs where the articles will arrive and the official veterinary inspector of such (c) and (d) of this section, the port of export prior to such transit. The region showing that the therein importation of serum from ruminants notification must include the: described hides or skins were taken that have been in any region classified (i) United States Veterinary Permit for from animals slaughtered in such as a Risk Class R3, R4, or RU region for Importation and Transportation of specified abattoir and found free from bovine spongiform encephalopathy is Controlled Materials and Organisms and anthrax, foot-and-mouth, rinderpest, prohibited, except that serum from Vectors permit number; bovine spongiform encephalopathy, ruminants may be imported for (ii) Times and dates of arrival in the lumpy skin disease (Neethling virus), scientific, educational, or research United States; Sheep pox, goat pox, African swine purposes if the Administrator (iii) Times and dates of exportation fever, hog cholera, and swine vesicular determines that the importation can be from the United States; disease. made under conditions that will prevent (iv) Mode of transportation; and (d) Hides or skins may be imported (v) Serial numbers of the sealed the introduction of bovine spongiform without other restriction if shown upon containers. encephalopathy into the United States. inspection by an inspector, or by (4) The articles must transit the certificate of the shipper or importer Serum from ruminants imported in United States in Customs bond. accordance with this paragraph must be satisfactory to said inspector, to have accompanied by a permit issued by (Approved by the Office of Management and been pickled in a solution of salt APHIS in accordance with § 104.3 of Budget under control number 0579–0015) this chapter, and must be moved and 2 Names of regions of this character will be 1 VS form 16–3 may be obtained from the furnished upon request made to the National Center handled as specified on the permit. National Center for Import and Export, Veterinary for Import and Export, Veterinary Services, APHIS, (c) Articles for cosmetics. The Services, APHIS, 4700 River Road Unit 39, 4700 River Road Unit 39, Riverdale, MD 20737– importation of collagen, collagen Riverdale, MD 20737–1231. 1231. Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17099 containing mineral acid and packed in mouth disease, rinderpest, bovine the therein described wool, hair, or barrels, casks, or tight cases while still spongiform encephalopathy, lumpy skin bristles were taken from animals wet with such solution. disease (Neethling virus), Sheep pox, slaughtered in such specified abattoir (e) Hides or skins may be imported goat pox, African swine fever, hog and found free from anthrax, foot-and- without other restriction if shown upon cholera, and swine vesicular disease. mouth disease, rinderpest, lumpy skin inspection by an inspector, or by They may not be removed therefrom disease (Neethling virus), Sheep pox, certificate of the shipper or importer except upon special permission of the goat pox, African swine fever, hog satisfactory to said inspector, to have Administrator, and upon compliance cholera, and swine vesicular disease. been treated with lime in such manner with all the conditions and (d) Wool, hair, or bristles that have and for such period as to have become requirements of this section relative to been scoured, thoroughly washed, or dehaired and to have reached the stage the movement of the said hides and dyed may be imported without other of preparation for immediate skins from the port of arrival to the said restriction. manufacture into products ordinarily establishment. (Approved by the Office of Management and made from rawhide. (Approved by the Office of Management and Budget under control number 0579–0015) (Approved by the Office of Management and Budget under control number 0579–0015) § 95.8 Wool, hair, and bristles; Budget under control number 0579–0015) § 95.7 Wool, hair, and bristles; importations permitted subject to § 95.6 Untanned hides and skins; requirements for unrestricted entry. restrictions. importations permitted subject to Wool, hair, or bristles derived from Wool, hair, or bristles imported into restrictions. ruminants and/or swine that do not the United States that do not meet the Hides or skins imported or offered for meet the conditions or requirements conditions or requirements of § 95.7 importation into the United States that specified in any one of paragraphs (a) to must be handled and treated in the do not meet the conditions or (d) of this section may not be imported following manner after arrival at the requirements of § 95.5 shall be handled except subject to handling and port of entry: and treated in the following manner treatment in accordance with § 95.8 (a) Such wool, hair, or bristles must after arrival at the port of entry: after their arrival at the port of entry: be consigned from the coast or border (a) They shall be consigned from the provided, however, that no bloodstained port of arrival to an approved coast or border port of arrival to an wool, hair, or bristles may be imported establishment: provided, however, that approved establishment and shall be under any condition: upon permission by the Administrator, subject to disinfection by such method (a) Such wool, hair, or bristles may be such wool, hair, or bristles may be or methods as the Administrator may imported without other restriction if stored for a temporary period in prescribe unless the said establishment originating in and shipped directly from approved warehouses under bond and discharges drainage into an approved a region classified as a Risk Class RN, under the supervision of an inspector: sewerage system or has approved R1, or R2 region for foot-and-mouth and provided further, that in-transit or chlorinating equipment adequate for the disease, rinderpest, lumpy skin disease in-bond shipments of wool, hair, or proper disinfection of effluents: (Neethling virus), Sheep pox, goat pox, bristles may go forward under customs provided, however, that, upon African swine fever, hog cholera, and seals from a coast or border port of permission of the Administrator, such swine vesicular disease. arrival, with the approval of an hides or skins may be stored for a (b) Wool or hair clipped from live inspector at said port, to another port for temporary period in approved animals or pulled wool or hair may be consumption entry, subject to the other warehouses under bond, and under the imported without other restriction if the provisions of this section. supervision of an inspector: and said wool or hair is reasonably free from (b) Such wool, hair, or bristles must provided further, that in-transit or in- animal manure in the form of dung be moved from the coast or border port bond shipments of hides or skins may locks or otherwise. of arrival or, in the case of in-transit or go forward under customs seals from a (c) Wool, hair, or bristles taken from in-bond shipments, from the interior coast or border port of arrival, with the sheep, goats, cattle, or swine, when such port to the approved establishment in approval of an inspector at said port, to animals have been slaughtered under cars or trucks or in vessel compartments another port in the United States for national government inspection in a with no other materials contained consumption entry subject to the other region 3 and in an abattoir in which is therein, sealed with seals of the provisions of this section. maintained an inspection service Department, that may not be broken (b) They must be moved from the determined by the Secretary of except by inspectors or other persons coast or border port of arrival or, in case Agriculture to be adequate to assure that authorized by the Administrator to do of in-transit or in-bond shipments, from such materials have been removed from so, or without sealing as aforesaid and the interior port to the approved animals found at time of slaughter to be with other freight when packed in tight establishment in cars or trucks or in free from anthrax, foot-and-mouth cases acceptable to an inspector. vessel compartments with no other disease, rinderpest, lumpy skin disease (c) Such wool, hair, or bristles must materials contained therein, sealed with (Neethling virus), Sheep pox, goat pox, be handled at the approved seals of the Department, that may not be African swine fever, hog cholera, and establishment under the direction of an broken except by inspectors or other swine vesicular disease, and to assure inspector, in a manner approved by the persons authorized by the Administrator further the identity of such materials Administrator to guard against the to do so, or without sealing as aforesaid until loaded upon the transporting dissemination of foot-and-mouth and with other freight when packed in vessel, may be imported without other disease, rinderpest, lumpy skin disease tight cases or casks acceptable to the restriction if accompanied by a (Neethling virus), Sheep pox, goat pox, inspector in charge at the port of entry. certificate bearing the seal of the proper African swine fever, hog cholera, and (c) They must be handled at the department of said national government swine vesicular disease. Such products approved establishment under the and signed by an official veterinary may not be removed therefrom except direction of an inspector in a manner inspector of such region showing that upon special permission of the approved by the Administrator to guard Administrator, and upon compliance against the dissemination of foot-and- 3 See footnote 2 in § 95.5. with all the conditions and 17100 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules requirements of this section relative to (Approved by the Office of Management and as trophies or for consignment to the movement of the said wool, hair, or Budget under control number 0579–0015) museums may be imported without bristles from the port of arrival to the § 95.10 Glue stock; importations permitted other restrictions. said establishment. subject to restrictions. (b) Clean, dry, hoofs disinfected in the country of origin may be imported (Approved by the Office of Management and Glue stock imported into the United without other restrictions if the Budget under control number 0579–0015) States that does not meet the conditions following conditions are met: or requirements of § 95.9 must be § 95.9 Glue stock; requirements for (1) The hoofs have been disinfected handled and treated in the following unrestricted entry. using one of the following methods: manner after arrival at the port of entry: (i) Dry heat at 180 °F (82.3 °C) for 30 Glue stock that does not meet the (a) It must be consigned from the minutes; conditions or requirements specified in coast or border port of arrival to an any one of paragraphs (a) to (c) of this (ii) Soaking in boiling water for 20 approved establishment and shall be minutes; section may not be imported into the subject to disinfection by such method United States, except subject to (iii) Soaking in a 0.1 percent chlorine or methods as the Administrator may bleach solution for 2 hours; handling and treatment in accordance prescribe, unless the said establishment with § 95.10 after arrival at the port of (iv) Soaking in a 5 percent acetic acid discharges drainage into an approved solution for 2 hours; or entry: sewerage system or has an approved (a) Glue stock originating in and (v) Soaking in a 5 percent hydrogen chlorinating equipment adequate for the peroxide solution for 2 hours. shipped directly from a region classified proper disinfection of effluents: as a Risk Class RN, R1, or R2 region for (2) The hoofs are accompanied by a Provided, however, that upon certificate issued by the national foot-and-mouth disease, rinderpest, permission by the Administrator, glue lumpy skin disease (Neethling virus), government of the country of origin and stock may be stored for a temporary signed by an official veterinary Sheep pox, goat pox, African swine period in approved warehouses under fever, hog cholera, and swine vesicular inspector of that country stating that the bond and under the supervision of an hoofs have been disinfected and disease may be imported without other inspector: And provided further, that in- restriction. describing the manner in which the transit or in-bond shipments of glue disinfection was accomplished. (b) Glue stock may be imported stock may go forward under customs without other restriction if found upon seals from a coast or border port of § 95.12 Bones, horns, and hoofs; inspection by an inspector, or by arrival with the approval of an inspector importations permitted subject to certificate of the shipper or importer at said port to another port for restrictions. satisfactory to said inspector, to have consumption entry, subject, after arrival Bones, horns, and hoofs, imported been properly treated by acidulation or at the latter port, to the other provisions into the United States, that do not meet by soaking in milk of lime or a lime of this section. the conditions or requirements of paste; or to have been dried so as to (b) It must be moved from the coast § 95.11 must be handled and treated in render each piece of the hardness of a or border port of arrival or, in case of in- the following manner after arrival at the sun-dried hide. transit or in-bond shipments, from the port of entry: (c) Glue stock taken from cattle, interior port to the approved (a) They must be consigned from the sheep, goats, or swine slaughtered under establishment in cars or trucks or in coast or border port of arrival to an national government inspection in a vessel compartments with no other approved establishment having facilities region and in an abattoir in which is materials contained therein, sealed with for their disinfection or their conversion maintained an inspection service seals of the Department, that may not be into products customarily made from determined by the Secretary of broken except by inspectors or other bones, horns, or hoofs: provided, Agriculture to be adequate to assure that persons authorized by the Administrator however, that in-transit or in-bond such materials have been removed from to do so, or without sealing as aforesaid shipments of bones, horns, or hoofs may animals found at time of slaughter to be and with other freight when packed in go forward under customs seals from a free from anthrax, foot-and-mouth tight cases or casks acceptable to an coast or border port of arrival, with the disease, rinderpest, bovine spongiform inspector at the port of entry. approval of an inspector at said port, to encephalopathy, lumpy skin disease (c) It must be handled at the approved another port for consumption entry (Neethling virus), Sheep pox, goat pox, establishment under the direction of an subject to the other provisions of this African swine fever, hog cholera, and inspector in a manner approved by the section. swine vesicular disease, and to assure Administrator to guard against the (b) They must be moved from the further the identity of such materials dissemination of foot-and-mouth coast or border port of arrival or, in the until loaded upon the transporting disease and rinderpest. It may not be case of in-transit or in-bond shipments, vessel, may be imported without other removed therefrom except upon special from the interior port to the approved restriction if accompanied by a permission of the Administrator, and establishment in cars or trucks with no certificate bearing the seal of the proper upon compliance with all the other materials contained therein, department of said national government conditions and requirements of this sealed with seals of the Department, that and signed by an official veterinary section relative to the movement of the may not be broken except by inspectors inspector of such country showing that said glue stock from the port of arrival or other persons authorized by the the therein described glue stock was to the said establishment. Administrator to do so, or without taken from animals slaughtered in such (Approved by the Office of Management and sealing as aforesaid and with other specified abattoir and found free from Budget under control number 0579–0015) freight when packed in tight cases or anthrax, foot-and-mouth disease, casks acceptable to an inspector at the rinderpest, bovine spongiform § 95.11 Bones, horns, and hoofs for port of entry. encephalopathy, lumpy skin disease trophies or museum; disinfected hoofs. (c) They must be handled at the (Neethling virus), Sheep pox, goat pox, (a) Clean, dry bones, horns, and hoofs, approved establishment under the African swine fever, hog cholera, and that are free from undried pieces of direction of an inspector, in a manner to swine vesicular disease. hide, flesh, and sinew and are imported guard against the dissemination of Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17101 anthrax, foot-and-mouth disease, § 95.15 Blood meal, blood albumin, spongiform encephalopathy, lumpy skin rinderpest, lumpy skin disease intestines, and other animal byproducts for disease (Neethling virus), Sheep pox, (Neethling virus), Sheep pox, goat pox, industrial use; requirements for goat pox, African swine fever, hog unrestricted entry. African swine fever, hog cholera, and cholera, and swine vesicular disease. swine vesicular disease, and the bags, Blood meal, blood albumin, bone They may not be removed therefrom meal, intestines, or other animal burlap, or other containers thereof, except upon special permission of the materials intended for use in the before leaving the establishment, must Administrator, and upon compliance industrial arts may not be imported into be disinfected by heat or otherwise, as with all the conditions and the United States except subject to directed by the Administrator, or requirements of this section relative to handling and treatment in accordance the movement of the said products from burned at the establishment. They may with § 95.16, unless such products not be removed therefrom except upon the port of arrival to the said originated in and were shipped directly establishment. special permission of the Administrator, from a region classified as Risk Class and upon compliance with all the RN, R1, or R2 region for foot-and-mouth (Approved by the Office of Management and Budget under control number 0579–0015) conditions and requirements of this disease, rinderpest, bovine spongiform section relative to the movement of the encephalopathy, lumpy skin disease § 95.17 Glands, organs, ox gall, and like said bones, horns, and hoofs. (Neethling virus), Sheep pox, goat pox, materials; requirements for unrestricted entry. (Approved by the Office of Management and African swine fever, hog cholera, and Budget under control number 0579–0015) swine vesicular disease. Glands, organs, ox gall or bile, bone (Approved by the Office of Management and marrow, and various like materials § 95.13 Bone meal for use as fertilizer or Budget under control number 0579–0015) derived from domestic ruminants or as feed for domestic animals; requirements for entry. § 95.16 Blood meal, blood albumin, swine, intended for use in the intestines, and other animal byproducts for manufacture of pharmaceutical products Steamed or degelatinized or special industrial use; importations permitted may not be imported except subject to steamed bone meal, that, in the normal subject to restrictions. handling and treatment in accordance process of manufacture, has been Blood meal, blood albumin, bone with § 95.18, unless such glands, organs, prepared by heating bone under a meal, intestines, or other animal or materials originated in and were minimum of 20 pounds steam pressure materials intended for use in the shipped directly from a region classified for at least one hour at a temperature of industrial arts, that do not meet the as a Risk Class RN, R1, or R2 region for not less than 250 °F (121 °C), may be conditions or requirements of § 95.15 foot-and-mouth disease, rinderpest, imported into the United States without must be handled and treated in the bovine spongiform encephalopathy, further restrictions for use as fertilizer or following manner after arrival at the lumpy skin disease (Neethling virus), as feed for domestic animals if such port of entry: Sheep pox, goat pox, African swine products are free from pieces of bone, (a) They must be consigned from the fever, hog cholera, and swine vesicular hide, flesh, and sinew and contain no coast or border port of arrival to an disease. more than traces of hair and wool. Bone approved establishment: provided, § 95.18 Glands, organs, ox gall, and like meal for use as fertilizer or as feed for however, that upon permission by the materials; importations permitted subject to domestic animals that does not meet Administrator, they may be stored for a restrictions. temporary period in approved these requirements will not be eligible Glands, organs, ox gall or bile, bone for entry. warehouses under bond and under the supervision of an inspector: and marrow, and various like materials § 95.14 Blood meal, tankage, meat meal, provided further, that in-transit or in- derived from domestic ruminants or and similar products, for use as fertilizer or bond shipments of such products may swine, that do not meet the animal feed; requirements for entry. go forward under customs seals from a requirements of § 95.17 may be imported for pharmaceutical purposes Dried blood or blood meal, lungs or coast or border port of arrival, with the approval of an inspector at said port, to only if they are in tight containers and other organs, tankage, meat meal, wool another port of consumption entry, consigned to an approved waste, wool manure, and similar subject after arrival at the latter port to establishment: provided, however, that products, for use as fertilizer or as feed the other provisions of this section. upon special permission of the for domestic animals, may not be (b) They must be moved from the Administrator, they may be stored for a imported into the United States except coast or border port of arrival or, in the temporary period in approved subject to handling and treatment in case of in-transit or in-bond shipments, warehouses under bond and under the accordance with paragraphs (a), (b), and from the interior port to the approved supervision of an inspector. They must (c) of § 95.16, unless: establishment in cars or trucks or in be handled and processed at the said (a) Such products originated in and vessel compartments with no other establishment in a manner approved by were shipped directly from a region materials contained therein, sealed with the Administrator, and the containers must be destroyed or disinfected as classified as a Risk Class RN, R1, or R2 seals of the Department, that may not be prescribed by him or her. They shall not region for foot-and-mouth disease, broken except by inspectors or other persons authorized by the Administrator be removed therefrom except upon rinderpest, bovine spongiform special permission of the Administrator, encephalopathy, lumpy skin disease to do so, or without sealing as aforesaid and with other freight when packed in and upon compliance with all the (Neethling virus), Sheep pox, goat pox, conditions and requirements of this African swine fever, hog cholera, and tight cases or casks acceptable to an inspector at the port of entry. section relative to the movement of the swine vesicular disease; or (c) They must be handled at the said glands, organs, ox gall, and like (b) The inspector at the port of entry approved establishment under the materials from the port of arrival to the finds that such products have been fully direction of an inspector in a manner to said establishment. processed by tanking under live steam guard against the dissemination of foot- (Approved by the Office of Management and or by dry rendering. and-mouth disease, rinderpest, bovine Budget under control number 0579–0015) 17102 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules

§ 95.19 Animal stomachs. § 95.23 Previously used meat covers; other than those in tight cases or casks, Stomachs or portions of the stomachs importations permitted subject to must affix to and maintain on both sides of ruminants or swine, other than those restrictions. of all such vehicles durable placards not imported for food purposes under the Cloth or burlap that has been used to less than 51⁄2 by 6 inches in size, on meat-inspection regulations of the cover fresh or frozen meats originating which must be printed with permanent Department, may not be imported into in any region classified as a Risk Class black ink and in boldface letters not less R3, R4, or RU region for rinderpest, foot- the United States without permission than 11⁄2 inches in height the words from the Administrator. Importations and-mouth disease, lumpy skin disease ‘‘Restricted import product.’’ These (Neethling virus), Sheep pox, goat pox, permitted shall be subject to such placards must also bear the words African swine fever, hog cholera, and restrictions as the Administrator may ‘‘Clean and disinfect this car or truck.’’ swine vesicular disease may not be deem necessary in each instance. Each of the waybills, conductors’ imported into the United States except (Approved by the Office of Management and manifests, memoranda, and bills of Budget under control number 0579–0015) under the following conditions: (b) The cloth or burlap must be lading pertaining to such shipments § 95.20 Animal manure. consigned from the coast or border port must have the words ‘‘Restricted import Manure of horses, cattle, sheep, other of arrival to an establishment product, clean and disinfect car or ruminants, and swine may not be specifically approved for the purpose by truck,’’ plainly written or stamped upon imported except upon permission from the Administrator. its face. If for any reason the placards the Administrator. Importations (c) The cloth or burlap must be required by this section have not been permitted shall be subject to such immediately moved from the coast or affixed to each car, or the billing has not restrictions as the Administrator may border port of arrival, or in the case of been marked by the initial or the deem necessary in each instance: in-transit or in-bond shipments from the connecting carrier, or the placards have Provided, however, That manure interior port, to the approved been removed, destroyed, or rendered produced by animals while in transit to establishment, in railroad cars or trucks, illegible, the placards must be the United States shall be subject only or in vessel compartments, with no immediately affixed or replaced and the to the requirements of the Department other material contained therein, sealed billing marked by the initial or regulations governing the importation of with seals of the Department, that may connecting carrier, the intention being livestock and other animals. not be broken, except by inspectors or that the billing accompanying the other persons authorized by the (Approved by the Office of Management and shipment must be marked and each car, Budget under control number 0579–0015) Administrator: provided, however, that truck or other vehicle placarded as upon permission of the Administrator, specified in this section from the time § 95.21 Hay and straw; requirements for such cloth or burlap may be stored for such shipment leaves the port of entry unrestricted entry. a temporary period in approved until it is unloaded at final destination Except as provided in § 95.28, hay or warehouses at the port of arrival under and the cars, trucks or other vehicles are straw may not be imported into the bond and under the supervision of an cleaned and disinfected as required by United States except subject to handling inspector. The material must be and treatment in accordance with disinfected and otherwise handled at § 95.26. § 95.22 after arrival at the port of entry, the establishment under the direction of (b) If it is necessary to unload enroute unless such hay or straw originated in an inspector in a manner approved by any of the materials or products and was shipped directly from a region the Administrator to guard against the transported in a placarded car, truck or classified as a Risk Class RN, R1, or R2 dissemination of foot-and-mouth other vehicle as provided in this region for foot-and-mouth disease, disease, rinderpest, lumpy skin disease section, the car, truck or other vehicle rinderpest, lumpy skin disease (Neethling virus), Sheep pox, goat pox, from which the transfer is made and any (Neethling virus), Sheep pox, goat pox, African swine fever, hog cholera, and part of the premises in or upon which African swine fever, hog cholera, swine swine vesicular disease, and the the product or material may have been vesicular disease, and restricted material may not be removed therefrom, placed in the course of unloading or ectoparasites. except upon special permission of the reloading must be cleaned and Administrator, until all of the disinfected by the carrier, in accordance § 95.22 Hay and straw; importations conditions and requirements of this permitted subject to restrictions. with the provisions of § 95.26, and the section have been complied with. Except as provided in § 95.28, hay or said carrier must immediately report the straw that does not meet the conditions (Approved by the Office of Management and matter, by telephone or FAX, to the or requirements of § 95.21 must be Budget under control number 0579–0015) Import/Export Products Staff, National handled and treated in the following § 95.24 Methods for disinfection of hides, Center for Import Export, APHIS, USDA, manner upon arrival at the port of entry: skins, and other materials. Telephone: 301–734–3294. Such report (a) Hay or straw packing materials Hides, skins, and other materials must include the following information: must be burned or disinfected at the required by the regulations in this part Nature of emergency; place where expense of the importer or consignee in to be disinfected must be subjected to product or material was unloaded; the manner and within the time directed disinfection by methods found original points of shipment and by the Administrator to prevent the satisfactory and approved by the destination; number and materials of the introduction of disease. Administrator. original car or truck; and number and (b) Hay or straw for use as feeding initials of the car, truck or other vehicle material, bedding, or similar purposes § 95.25 Transportation of restricted import into which the product or material is must be stored and held in quarantine products; placarding cars and marking reloaded in case the original car or truck for a period of not less than 90 days in billing; unloading enroute. is not used. an approved warehouse at the port of (a) Transportation companies or other entry and must be otherwise handled as operators of cars, trucks or other (Approved by the Office of Management and directed by the Administrator to prevent vehicles carrying import products or Budget under control number 0579–0015) the introduction of disease. materials moving under restriction, Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17103

§ 95.26 Railroad cars, trucks, boats, part, and from the portable chutes or and-mouth disease, lumpy skin disease aircraft and other means of conveyance, other appliances, fixtures or areas used (Neethling virus), Sheep pox, goat pox, equipment or containers, yards, and in loading and unloading same, and African swine fever, hog cholera, and premises; cleaning and disinfection. destroy the litter and other refuse by swine vesicular disease and tick Railroad cars, trucks, boats, aircraft burning or by other methods approved infestation; or other disinfectants or and other means of conveyance, by the Administrator, and saturate the treatments approved by the equipment or containers, yards, and entire surface of the said decks, Administrator. premises that have been used in the compartments, and other parts of the transportation, handling, or storing of boat with a permitted disinfectant § 95.27 Regulations applicable to products from Territorial possessions. restricted import products or materials, approved for use in this part. other than those contained in leakproof (3) Buildings, sheds, and premises The regulations in this part shall be cases or casks, must be cleaned and required by this part to be disinfected applicable to all the products and disinfected with a disinfectant approved must be treated in the following materials specified in this part that are for use in this part under the manner: Collect all litter and other imported into the United States from supervision of an inspector within the refuse therefrom and destroy the same any place under the jurisdiction of the time and in the manner provided in this by burning or other approved methods, United States to which the animal- section. Except as provided in and saturate the entire surface of the quarantine laws of this country do not paragraph (a) of this section, such fencing, chutes, floors, walls, and other apply. railroad cars, trucks, boats, aircraft and parts with a permitted disinfectant other means of conveyance, equipment § 95.28 Hay or straw and similar material approved for use in this part. from tick-infested regions. or containers, may not be moved in (c) Permitted disinfectants. The Hay or straw, grass, or similar interstate or foreign commerce until disinfectants permitted for use in they have been so treated. material from tick-infested pastures, disinfecting railroad cars, trucks, boats, ranges, or premises may disseminate the (a) Cars to be cleaned and disinfected aircraft and other means of conveyance, by final carrier at destination. Cars contagion of splenetic, Southern or equipment or containers, yards, and Texas fever when imported for animal required by this part to be cleaned and premises against infection of foot-and- disinfected must be so treated by the feed or bedding; therefore, such hay or mouth disease, rinderpest, lumpy skin straw, grass, or similar materials may final carrier at destination as soon as disease (Neethling virus), Sheep pox, possible after unloading and before the not be imported into the United States goat pox, African swine fever, hog from regions classified as Risk Class R3, same are moved from such final cholera, and swine vesicular disease are destination for any purpose: Provided, R4, or RU regions for restricted ticks, freshly prepared solutions of: unless such material is first disinfected however, That when the products or (1) Sodium carbonate (4 percent) in with a disinfectant specified in materials are destined to points at the proportion of 1 pound to 3 gallons § 95.26(d). which an inspector or other authorized of water; representative of APHIS is not (2) Sodium carbonate (4 percent) plus maintained or present or where proper PART 96ÐRESTRICTION OF sodium silicate (0.1 percent) in the IMPORTATIONS OF FOREIGN ANIMAL facilities cannot be provided, the proportion of 1 pound of sodium transportation company must seal, bill, CASINGS OFFERED FOR ENTRY INTO carbonate plus sodium silicate to 3 THE UNITED STATES and forward the cars in which the gallons of water; or products or materials were transported (3) Sodium hydroxide (Lye) prepared 53. The authority citation for part 96 to a point to be agreed upon between the in a fresh solution in the proportion of would continue to read as follows: transportation company and APHIS, and not less than 1 pound avoirdupois of Authority: 21 U.S.C. 111, 136, 136a; 7 CFR the transportation company must there sodium hydroxide of not less than 95 2.22, 2.80, and 371.2(d). clean and disinfect the said cars under percent purity to 6 gallons of water, or 54. In § 96.1, the definition of the supervision of an inspector. one 131⁄2-ounce can to 5 gallons of Administrator would be revised to read (b) Methods of cleaning and water.4 as follows: disinfecting. (1) Railroad cars, trucks, (d) Permitted disinfectants against aircraft and means of conveyance other ticks. The disinfectants permitted for § 96.1 Definitions. than boats, equipment or containers, use against tick infestation are liquefied Administrator. The Administrator of required by this part to be cleaned and phenol (U. S. P. strength 87 percent the Animal and Plant Health Inspection disinfected must be treated in the phenol) in the proportion of at least 6 Service or any other employee of the following manner: Collect all litter and fluid ounces to one gallon of water; or Animal and Plant Health Inspection other refuse therefrom and destroy by chlorinated lime (U. S. P. strength 30 Service, United States Department of burning or other method approved by percent available chlorine) in the Agriculture, delegated to act in the the Administrator; clean the exterior proportion of one pound to three gallons Administrator’s stead. and interior of the cars or trucks, and of water; or any one of the cresylic the areas of the aircraft or other means * * * * * disinfectants permitted by APHIS in 55. Section 96.2 would be revised to of conveyance, equipment or containers §§ 71.10 and 71.11 of this chapter, in the read as follows: that may have been contaminated; and proportion of at least four fluid ounces saturate the entire surface with a to one gallon of water; or through § 96.2 Casings from regions classified as permitted disinfectant approved for use application of boiling water if the Risk Class R3, R4, or RU for African swine in this part. treatment is against rinderpest, or foot- fever or bovine spongiform (2) Boats required by this part to be encephalopathy. cleaned and disinfected must be treated 4 Due to the extreme caustic nature of sodium (a) The importation of swine casings in the following manner: Collect all hydroxide solution, precautionary measures such as that originated in or were processed in litter and other refuse from the decks, the wearing of rubber gloves, boots, raincoat and a region that is classified as Risk Class goggles should be observed. An acid solution such compartments, and all other parts of the as vinegar shall be kept readily available in case any R3, R4, or R4 for African swine fever is boat used for the transportation of the of the sodium hydroxide should come in contact prohibited, with the following products or materials covered by this with the body. exception: Swine casings that originated 17104 Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules in a region designated as Risk Class RN, imported into the United States unless 68. In § 98.14, the introductory text to R1, or R2 for African swine fever may it is from a region that is classified as paragraph (a) would be revised to read be processed in a region classified as R3, Risk Class RN, R1, or R2 for rinderpest as follows: R4, or RU for African swine fever, if and foot-and-mouth disease, and: processed in an establishment that (a) The embryo is exported to the § 98.14 Health certificate. meets the criteria set forth in § 94.5(d) United States from the region in which (a) Ruminant and swine embryos may of this chapter. it was conceived; be imported into the United States from (b) The importation of ruminant * * * * * a region that is classified as R3, R4, or casings that originated in or were (f) There is no basis for denying an RU for rinderpest or foot-and-mouth processed in any region that is classified import permit for the donor sire or disease only if accompanied by a health as Risk Class R3, R4, or RU for bovine donor dam under § 93.304(a)(2) of this certificate issued by: spongiform encephalopathy is chapter for horses, § 93.404(a)(2) of this * * * * * prohibited, except for bovine stomachs. chapter for ruminants, and 69. In § 98.15, paragraph (a)(5)(ii) § 96.3 [Amended] § 93.504(a)(2) of this chapter for swine; would be amended by removing the word ‘‘country’’ and replacing it with 56. Section 96.3, paragraph (a), would * * * * * the word ‘‘region’’ and the introductory be amended by removing the words § 98.4 [Amended] text of the section would be revised to ‘‘foreign country’’ and adding in their 62. In § 98.4, paragraphs (c)(1) and read as follows: place the words ‘‘foreign region’’. (c)(5), the word ‘‘country’’ would be 57. Section 96.10 would be amended removed and the word ‘‘region’’ would § 98.15 Health requirements. by revising the introductory text of be added in its place. Ruminant and swine embryos may be paragraph (a) to read as follows: 63. Section 98.6 would be revised to imported from a region that is classified § 96.10 Uncertified casings; transportation read as follows: as Risk Class R3, R4, or RU for for disinfection; original shipping rinderpest or foot-and-mouth disease containers; disposition of salt. § 98.6 Ports of entry. only if all of the following conditions (a) Foreign animal casings imported An embryo shall not be imported into are met: into the United States without the United States unless at a port of * * * * * certification may be forwarded in entry listed in § 93.303 of this chapter 70. In § 98.16, the introductory text, customs custody to a USDA-approved for horses, § 93.403 of this chapter for the first sentence would be revised to facility for disinfection under APHIS ruminants, or § 92.503 of this chapter read as follows: supervision and release by the United for swine. § 98.16 The embryo collection unit. States Customs authorities, provided § 98.7 [Amended] that before being transported over land Ruminant and swine embryos may be in the United States each and every 64. In § 98.7, paragraph (g) would be imported into the United States from a container of such casings shall be amended by removing the word region that is classified as R3, R4, or RU disinfected by the application of a ‘‘country’’ and adding the word for rinderpest or foot-and-mouth disease solution of sodium hydroxide prepared ‘‘region’’ in its place. only if they were conceived, collected, as follows: 65. In part 98, the heading for subpart processed, and stored prior to B would be revised to read: * * * * * importation at an embryo collection 58. Sections 96.15 and 96.16 would be Subpart BÐRuminant and Swine unit. * * * removed. Embryos from Regions Classified as * * * * * Risk Class R3, R4, or RU for § 98.17 [Amended] PART 98ÐIMPORTATION OF CERTAIN Rinderpest or Foot-and-Mouth Disease ANIMAL EMBRYOS AND ANIMAL 71. In § 98.17, paragraphs (f)(6)(i) and SEMEN 66. Section 98.12, paragraph (a), (f)(6)(ii) would be amended by removing would be revised to read as follows: 59. The authority citation for part 98 the word ‘‘country’’ each time it appears, and adding in its place the would continue to read as follows: § 98.12 General prohibitions. word ‘‘region.’’ Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; (a) Ruminant and swine embryos may 72. Section 98.34 would be amended 21 U.S.C. 103–105, 111, 134a, 134b, 134c, not be imported from regions that are as follows: 134d, 134f, 136, and 136a; 31 U.S.C. 9701; 7 classified as Risk Class R3, R4, or RU for a. The word ‘‘country’’ would be CFR 2.22, 2.80, and 371.2(d). rinderpest or foot-and-mouth disease, removed and the word ‘‘region’’ would except in accordance with this subpart. 60. In part 98, the heading for subpart be added in its place in the following A would be revised to read: * * * * * places: 67. Section 98.13, paragraph (a), i. Paragraph (a)(1), each time it Subpart AÐRuminant and Swine would be revised to read as follows: Embryos from Regions Classified as appears; Risk Class RN, R1, or R2 for § 98.13 Import permit. ii. Paragraph (a)(3), each time it Rinderpest and Foot-and-Mouth (a) Ruminant and swine embryos and appears; Disease; and Embryos of Horses and all test samples required by this subpart iii. Paragraph (c)(1)(ii); Asses may be imported into the United States iv. Paragraph (c)(3); v. Paragraph (c)(4); and 61. In § 98.3, the introductory text, from regions that are classified as Risk paragraph (a), and paragraph (f) would Class R3, R4, or RU for rinderpest or vi. Paragraph (c)(5). be revised to read as follows: foot-and-mouth disease only if b. Paragraph (a)(2) would be revised accompanied by import permits issued to read as set forth below. § 98.3 General conditions. by the Animal and Plant Health c. Paragraph (c), the heading and Except as provided in subpart B of Inspection Service (APHIS). introductory text, would be revised to this part, an animal embryo shall not be * * * * * read as set forth below: Federal Register / Vol. 61, No. 76 / Thursday, April 18, 1996 / Proposed Rules 17105

§ 98.34 Import permits for poultry semen and animal semen. (a) * * * (2) An application for permit to import animal semen will be denied for semen from ruminants or swine from any region that is classified as Risk Class R3, R4, or RU for foot-and-mouth disease or rinderpest, except as provided in paragraph (c) of this section. * * * * * (c) Animal semen from regions classified as Risk Class R3, R4, or RU for foot-and-mouth disease or rinderpest. Importation of semen of ruminants or swine, originating in any region that is classified as Risk Class R3, R4, or RU for foot-and-mouth disease or rinderpest is prohibited, except that semen from ruminants or swine originating in such a region may only be imported into the United States at the port of New York and later released from such port, provided the following conditions have been fulfilled: * * * * * Done in Washington, DC, this 26th day of March 1996. Lonnie J. King, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 96–9027 Filed 4–17–96; 8:45 am] BILLING CODE 3410±34±P