62353

Rules and Regulations Federal Register Vol. 68, No. 213

Tuesday, November 4, 2003

This section of the FEDERAL REGISTER Submit electronic comments to http:// were reported to have been hospitalized; contains regulatory documents having general www.fda.gov/dockets/ecomments. however, some of these hospitalizations applicability and legal effect, most of which For CDC: Send written comments on were for isolation purposes unrelated to are keyed to and codified in the Code of the information collection to Anne illness. Among those hospitalized, two Federal Regulations, which is published under O’Connor, CDC Assistant Reports were children who required intensive 50 titles pursuant to 44 U.S.C. 1510. Clearance Officer, 1600 Clifton Rd., MS care, one for severe monkeypox- The Code of Federal Regulations is sold by E11, Atlanta, GA 30333. Comments on associated encephalitis (encephalitis is the Superintendent of Documents. Prices of the rule itself should be sent to FDA’s an inflammation of the brain), and one new books are listed in the first FEDERAL Division of Dockets Management (see with profound painful cervical and REGISTER issue of each week. FDA addresses). tonsillar adenopathy (adenopathy refers FOR FURTHER INFORMATION CONTACT: to an enlargement of the glands) and For information regarding FDA: Philip diffuse pox lesions, including lesions in DEPARTMENT OF HEALTH AND L. Chao, Office of Policy and Planning the oropharynx. Both children HUMAN SERVICES (HF–23), Food and Drug recovered from their illness. Administration, 5600 Fishers Lane, In the United States, individuals Food and Drug Administration Rockville, MD 20857, 301–827–0587. apparently began contracting For information regarding CDC: James monkeypox in early May, 2003, 21 CFR Parts 16 and 1240 E. Barrow, National Center for Infectious primarily as a result of contact with [Docket No. 2003N–0400] Diseases, Centers for Disease Control prairie dogs that had contracted and Prevention, Mailstop C–14, 1600 monkeypox from diseased African RIN 0910–ZA21 Clifton Rd., Atlanta, GA 30333, 404– rodents. Investigations indicate that a 498–1600. Texas animal distributor imported a Centers for Disease Control and SUPPLEMENTARY INFORMATION: shipment of approximately 800 small Prevention mammals from Ghana on April 9, 2003, I. What Is Monkeypox, and How Did It and that shipment contained 762 42 CFR Part 71 Spread in the United States? African rodents, including rope Monkeypox is a rare, zoonotic, viral squirrels (Funiscuirus sp.), tree squirrels Control of Communicable Diseases; disease that occurs primarily in the rain (Heliosciurus sp.), Gambian giant Restrictions on African Rodents, forest countries in central and west pouched rats (Cricetomys sp.), brushtail Prairie Dogs, and Certain Other Africa. (A zoonotic disease is a disease porcupines (Atherurus sp.), dormice Animals of animals that can be transmitted to (Graphiurus sp.), and striped mice humans under natural conditions.) The (Hybomys sp.). Some animals were AGENCIES: Centers for Disease Control and Prevention, Food and Drug illness was first noted in monkeys in infected with monkeypox, and CDC Administration (HHS). 1958 (which explains its name), but, in laboratory testing confirmed the Africa, serologic evidence of presence of monkeypox in several ACTION: Interim final rule; opportunity monkeypox infection has been found in rodent species, including one Gambian for public comment. many other species, including some giant pouched rat, three dormice, and SUMMARY: The Centers for Disease species of primates, rodents, and two rope squirrels (Ref. 4). Of the 762 Control and Prevention (CDC) and the lagomorphs (which includes such rodents from the original shipment, 584 Food and Drug Administration (FDA) animals as rabbits). African rodents are have been traced to distributors in six are issuing this interim final rule to considered to be the most likely natural states. A total of 178 African rodents amend their regulations to establish new host of the monkeypox virus (Ref. 1). could not be traced beyond the point of restrictions and modify existing In humans, monkeypox is marked by entry in Texas because records were not restrictions on the import, capture, rashes that are similar to those seen in available (Ref. 4). The number of transport, sale, barter, exchange, smallpox; other signs and symptoms animals traced may change as the distribution, and release of African include a temperature at or above 99.3 investigation continues. degrees, chills and/or sweats, headache, rodents, prairie dogs, and certain other II. What Actions Have Been Taken to backache, lymphadenopathy (a disease animals. We are taking this action to Prevent the Spread of Monkeypox? prevent the spread of monkeypox, a of the lymph nodes), sore throat, cough, communicable disease, in the United and shortness of breath (Ref. 2). The Non-native animal species, such as States. disease’s incubation period is the African rodents, can create serious approximately 12 days (Ref. 3). In public health problems when they DATES: The interim final rule is effective Africa, monkeypox has a mortality rate introduce a new disease, such as on November 4, 2003. Submit written or in humans ranging from 1 to 10 percent. monkeypox, to the native animal and electronic comments on this interim As of July 8, 2003, there have been 35 human populations. The transportation, final rule by January 20, 2004. laboratory-confirmed cases of sale, or distribution of an infected ADDRESSES: For FDA: Send written monkeypox in people in the United animal, or the release of an infected comments on the rule and on the States, and about another three dozen animal into the environment can result information collection to the Division of suspect and probable cases under in the further spread of disease to other Dockets Management (HFA–305), Food investigation, in Illinois, Indiana, animal species and to humans. and Drug Administration, 5630 Fishers Kansas, Ohio, Missouri, and Wisconsin Several States have issued orders or Lane, rm. 1061, Rockville, MD 20852. (Ref. 4). As of July 11, 2003, 16 persons emergency rules to prohibit the

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importation, sale, distribution, release, outbreak (Ref. 13). We now are able to and other animals that may carry the disposal, and/or display of prairie dogs provide a more detailed set of measures monkeypox virus.’’ and certain rodents (Refs. 5 through 11). aimed at creating a regulatory approach 2. What Does the Rule Prohibit? (21 CFR However, these State efforts are limited to prevent the monkeypox virus from 1240.63(a)) to their respective jurisdictions, and becoming established and spreading in some State orders or rules expire on a the United States, with exemption 21 CFR 1240.63(a)(1) contains several specific date, while others differ in the procedures to accommodate special general prohibitions. In brief, under 21 types of animals and actions that are circumstances, and are doing so by CFR 1240.63(a)(1)(i), regardless of your covered. Communicable diseases, such issuing this interim final rule. This status (such as a pet dealer, pet owner, as monkeypox, are not confined by State interim final rule supersedes the June researcher, animal trapper, zoological borders and, as shown by the presence 11, 2003, order. As appropriate, we will park administrator, etc.), you must not of the monkeypox virus in prairie dogs, amend the interim final rule in response capture, offer to capture, transport, offer may affect multiple animal species. to comments and to any new to transport, sell, barter, or exchange, Consequently, Federal action was developments in the monkeypox offer to sell, barter, or exchange, necessary to help prevent the spread of outbreak. distribute, offer to distribute, or release monkeypox. On June 11, 2003, the This interim final rule creates two into the environment: • Director of CDC and the Commissioner complementary regulations. First, with Prairie dogs (Cynomys sp.), • of Food and Drugs, under 42 CFR 70.2 respect to certain animals that are in the African Tree squirrels (Heliosciurus and 21 CFR 1240.30 respectively, issued United States, the interim final rule sp.), • Rope squirrels (Funisciurus sp.), a joint order (Ref. 12) prohibiting, until adds 21 CFR 1240.63, entitled ‘‘African • further notice, the transportation or rodents and other animals that may African Dormice (Graphiurus sp.), • Gambian giant pouched rats offering for transportation in interstate carry the monkeypox virus.’’ FDA will enforce 21 CFR 1240.63. Second, for (Cricetomys sp.), commerce, or the sale, offering for sale, • Brush-tailed porcupines (Atherurus African rodents that are being imported or offering for any other type of sp.), commercial or public distribution, or offered for import to the United • Striped mice (Hybomys sp.), or including release into the environment, States, the interim final rule adds 42 • Any other animal so prohibited by of: CFR 71.56, that is also entitled ‘‘African • order of the Commissioner of Food and Prairie dogs (Cynomys sp.); rodents and other animals that may Drugs because of that animal’s potential • Tree squirrels (Heliosciurus sp.); carry the monkeypox virus.’’ CDC will • to transmit the monkeypox virus. Rope squirrels (Funisciurus sp.); enforce 42 CFR 71.56. Together, 21 CFR For convenience, this preamble will • Dormice (Graphiurus sp.); 1240.63 and 42 CFR 71.56 are intended • refer to the above animals as ‘‘listed Gambian giant pouched rats to prevent the establishment and spread animals.’’ (Cricetomys sp.); of the monkeypox virus in the United The interim final rule covers the • Brush-tailed porcupines (Atherurus States. listed animals because animals from sp.), and Section 361 of the Public Health • those species have been associated, Striped mice (Hybomys sp.). Service Act (PHS act) (42 U.S.C. 264) either directly through laboratory tests The June 11, 2003, order did not serves as the legal authority for both 21 or indirectly through epidemiological apply to the transport of these animals CFR 1240.63 and 42 CFR 71.56. Section evidence, in the current outbreak of the to veterinarians or animal control 361 of the PHS act gives the Secretary monkeypox virus in humans (Ref. 14). officials or other entities under guidance of Health and Human Services the In general, the animals identified in 21 or instructions issued by Federal, State, authority to make and enforce CFR 1240.63 are the same as those listed or local government authorities. In regulations to prevent the introduction, in the CDC-FDA order dated June 11, addition, under 42 CFR 71.32(b), CDC transmission, and spread of 2003, except that the rule also refers to implemented an immediate embargo on communicable diseases from foreign other, yet-unspecified kinds of animals the importation of all rodents from countries into the States or from one that the Commissioner of Food and Africa (order Rodentia). State to another State. As we explain in Drugs may prohibit by order. FDA Both CDC and FDA are also working section IV of this document, both FDA included the latter ‘‘catch-all’’ provision closely with other Federal agencies, and CDC have issued regulations under in § 1240.63 because the agency cannot such as the Animal and Plant Health section 361 of the PHS act, and several preclude the possibility that monkeypox Inspection Service (APHIS) in the FDA regulations are similar or identical may spread to other animal species, Department of Agriculture (USDA), the to CDC regulations. Here, however, the and, if monkeypox is found in other Fish and Wildlife Service (FWS) in the responsibilities are being divided animals, FDA needs to be able to list Department of the Interior, Customs and between our two agencies. FDA’s those animals quickly. FDA derives its Border Protection in Department of regulation focuses on animals moving authority to list such animals by order Homeland Security, and the Department between and within States while CDC’s from section 361 of the Public Health of Transportation. FDA and CDC are regulation focuses on imported animals. Service Act, which is the same statutory also working with numerous State and Our goal in creating separate FDA and authority under which it is issuing this local agencies to prevent further CDC regulations is to use our limited interim final rule. This statutory exposure of animals and people to the resources to deal with the current provision authorizes the Secretary to monkeypox virus. monkeypox situation in the most make and enforce regulations to prevent efficient manner possible. III. What Does The Interim Final Rule the introduction, transmission, and Do? B. What Does FDA’s Rule Say? spread of communicable diseases. Section 1240.63(b)(1) of the interim A. Why Are FDA and CDC Issuing an 1. Where Is the Rule Codified? (21 CFR final rule (which we discuss later in this Interim Final Rule? 1240.63) section) allows FDA to issue orders We issued the June 11, 2003, order to As we stated in section III.A of this causing such animals to be quarantined address quickly what was then a new document, the interim final rule adds 21 or destroyed and to ‘‘take any other and rapidly developing monkeypox CFR 1240.63, entitled ‘‘African rodents action necessary to prevent the spread

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of the monkeypox virus.’’ Such ‘‘other ‘‘capture’’ within 21 CFR extent possible, 21 CFR 1240.63(a)(1)(i) actions’’ may include issuing orders 1240.63(a)(1)(i). We recommend that pertains to dead animals. necessary to prevent the spread of you dispose of dead prairie dogs 21 CFR 1240.63(a)(1)(ii) states that monkeypox. An order adding animals to appropriately in consultation with State you must not prevent or attempt to those ‘‘listed animals’’ that have the wildlife control officials and following prevent FDA from causing a listed potential to transmit the monkeypox applicable CDC guidance. The animal to be quarantined or destroyed virus is such an order since control of prohibition against capture and offers to pursuant to a written order for the animals that may transmit monkeypox capture is an appropriate and logical animal’s quarantine or destruction. (For is necessary to prevent the spread of this extension of the June 11, 2003, order purposes of this rule, ‘‘quarantine’’ communicable disease. because, for example, it would be means that the animal is held or stored The interim final rule prohibits illogical to prohibit wild prairie dogs in an isolated area, and all further capture, offers to capture, transport, from being transported, but still allow movement has been restricted so as not offers to transport, sale, barter, or them to be captured. An infectious to expose other animals.) Although most exchange, offers to sell, barter, or animal could transmit the monkeypox individuals will cooperate with a exchange distribution, offers to virus to humans during its capture, just written order to destroy an infected distribute, or release of a listed animal as it could transmit the monkeypox animal, some individuals may want to into the environment regardless of virus when a human handled the animal avoid causing an animal’s destruction whether the activity is interstate or during transport. Therefore, the interim by releasing the animal instead (Ref. 15). intrastate. The June 11, 2003, order final rule prohibits the capture of listed Releasing an infected or potentially referred to ‘‘transportation in interstate animals and offers to capture such infected animal would create a serious commerce.’’ This created some animals. risk to animal and human health confusion about whether the order Furthermore, 21 CFR 1240.63(a)(1)(i) because the monkeypox virus could applied to activities occurring within a prohibits the distribution of listed then spread to domestic animal species State. In this interim final rule, FDA animals. Prohibiting distribution is and to humans and could become makes clear that the restrictions apply to another appropriate and logical established in the United States. both interstate and intrastate activities. extension of the June 11, 2003, order. Therefore, if you prevent or attempt to The interim final rule must reach The June 11, 2003, order prohibited, in prevent FDA from causing an animal to intrastate activities because FDA cannot relevant part, ‘‘offering for commercial be quarantined or destroyed, you may effectively prevent interstate or public distribution,’’ yet was silent be subject to criminal penalties. transmission of communicable disease regarding the actual distribution of Penalties are discussed in part IV below. without addressing intrastate listed animals. To clarify FDA’s intent, FDA repeats that prohibiting the transmission. This is due to the fact that 21 CFR 1240.63(a)(1)(i) prohibits the capture, offer to capture, transport, offer an infected animal could transmit the distribution of listed animals in to transport, sale, barter, or exchange, monkeypox virus to other animals addition to the other prohibitions. FDA offer to sell, barter, or exchange, within a State, and eventually and has also simplified the rule by distribution, offer to distribute, and inevitably the monkeypox virus would prohibiting offers to distribute listed release of listed animals is vital to be transmitted to other States as infected animals rather than ‘‘offers for prevent the monkeypox virus from wild animals or even infected, commercial or public distribution’’ that becoming established and spreading in domesticated animals crossed State were in the June 11, 2003, order. The the United States. Nevertheless, the borders. Effective intrastate controls are, June 11, 2003, order made no agency also recognizes that there are therefore, an integral part of efforts to distinction between ‘‘commercial or limited circumstances warranting prevent interstate transmission of public distribution’’ and other types of exemptions from some prohibitions, communicable disease. distribution, nor did it indicate that such as the need to transport an animal 21 CFR 1240.63(a)(1)(i) also prohibits non-commercial or nonpublic for zoological, educational, medical, the capture and offers to capture listed distribution presented lesser risk of scientific, or other purposes. animals. For purposes of this rule, transmitting the monkeypox virus. Consequently, 21 CFR 1240.63(a)(2) ‘‘capture’’ means the act of catching or Consequently, 21 CFR 1240.63(a)(1)(i) allows you to: confining an animal in the wild with the now states, in relevant part, that you • Transport a listed animal to a intent of removing that animal for sale, must not ‘‘offer to distribute’’ a listed veterinarian or animal control official barter, or exchange, distribution, and/or animal. for veterinary care, quarantine, or release into the environment. So, for 21 CFR 1240.63(a)(1)(i) also prohibits destruction purposes; and example, 21 CFR 1240.63(a)(1)(i) ‘‘sale, barter, or exchange’’ and ‘‘offers • Capture, offer to capture, transport, prohibits a person from taking prairie to sell, barter, or exchange’’ listed offer to transport, sell, barter, or dogs from their burrows for purposes of animals. Animals are sometimes traded exchange, offer to sell, barter, or selling those prairie dogs, but it would or exchanged at ‘‘swap meets,’’ and such exchange, distribute, offer to distribute, not consider the act of immobilizing a trades or exchanges might not be and/or release a listed animal into the prairie dog, taking measurements or considered to be ‘‘sales.’’ Therefore, 21 environment after receiving written biological samples (such as blood CFR 1240.63(a)(1)(i) prohibits the sale, permission from FDA. Section samples), and then releasing the prairie barter, or exchange of listed animals and 1240.63(a)(2)(ii) states, however, that dog as constituting ‘‘capture.’’ Similarly, offers to sell, barter, or exchange listed you may not seek written permission to if a prairie dog escaped from its cage in animals. sell, barter, exchange, or offer to sell, a pet store, catching the prairie dog to FDA wishes to clarify that 21 CFR barter, or exchange a listed animal as a put it back in its cage would not 1240.63 applies regardless of whether pet. We do not intend to permit pet constitute ‘‘capture’’ within 21 CFR an animal is alive or dead. Dead animals sales (or barter or exchange) because the 1240.63(a)(1)(i). As another example, could still harbor the monkeypox virus monkeypox outbreak developed in the individuals sometimes shoot prairie and could be infectious, so the agency pet industry, and exposure to infected dogs because their burrows may present cannot ignore such dead animals as a animals intended as pets led to a hazard to cattle and horses; shooting potential source for infection. Therefore, infections in prairie dogs. The infected a prairie dog would not constitute to protect the public health to the best prairie dogs, in turn, infected humans.

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Thus, compared to animals in the wild guidance document to describe the Translocation or Transportation of pets present a greater potential risk for types of information it would like to see Prairie Dogs’’ (‘‘Wild-to-Wild transmitting the monkeypox virus. in an exemption request. Under 21 CFR document’’) (Ref. 17). The Wild-to-Wild To illustrate when transport of a listed 1240.63(a)(2)(ii)(C), FDA will respond, document was intended to address animal to a veterinarian or animal in writing, to all requests, and it also situations where a wild population of control official would be allowed, may impose conditions in granting an prairie dogs would be relocated to assume that an individual has a prairie exemption. If FDA decides against another wild habitat, and the document dog that appears to be ill. Section granting written permission, that suggested that States that have not been 1240.63(a)(1)(i) would prohibit decision could be reviewed under 21 implicated in the monkeypox outbreak transportation of that animal, yet, under CFR 10.75 (‘‘Internal agency review of issue guidance or instructions for 21 CFR 1240.63(a)(2)(i), an individual decisions’’). translocating prairie dogs within a State, could transport the prairie dog to a To illustrate when a person might and it listed the States that had been veterinarian for treatment. As another seek written permission from FDA, the implicated in the monkeypox outbreak example, individuals might shoot agency notes that efforts to reintroduce as of June 27, 2003. The Wild-to-Wild prairie dogs because their burrows black-footed ferrets into certain areas document was interpreted as giving present a hazard to cattle and horses. In may depend on the ability to transport State and local governments in such a situation, 21 CFR 1240.63(a)(1)(i) wild prairie dogs and release them into nonimplicated States the ability to would prohibit transportation of the the environment (Ref. 16). The black- decide on translocating prairie dogs prairie dog carcasses. However, under footed ferrets use prairie dog burrows without having to obtain an exemption 21 CFR 1240.63(a)(2)(i), an individual for shelter and also feed on prairie dogs. from FDA or CDC. However, the policies could transport the prairie dog carcasses Thus, in this example, biologists expressed in the Wild-to-Wild to animal control officials for working to reintroduce black-footed document have caused some incineration or other appropriate means ferrets would seek written permission uncertainty, particularly as some States of disposal. from FDA to capture, transport, and have been listed as being affected by the 21 CFR 1240.63(a)(2)(ii)(A) describes release prairie dogs in connection with monkeypox virus, and then ‘‘de-listed.’’ the procedures for seeking written each black-footed ferret program. They For example, if a person began permission from FDA. 21 CFR would also remain subject to any other translocating prairie dogs in a non-listed 1240.63(a)(2)(ii)(B) requires you to state Federal, State, local or tribal State, but the State was then listed the reasons why you need an requirements. before the translocation process could exemption, describe the animals In the previous example, the efforts be completed, should that person seek involved, describe the number of involving the black-footed ferrets may an exemption from FDA for those animals involved, describe how the have been the subject of other Federal prairie dogs that had not been animals will be transported (including and State permits. We acknowledge that translocated before the State was listed? carrying containers or cages, the June 11, 2003, order stated that its Or could the person complete the precautions for handlers, types of prohibitions did not apply to persons translocation process without an vehicles used, and other procedures to who transport listed animals to exemption from FDA because the minimize exposure of animals and veterinarians or animal control officials translocation process began when the precautions to prevent animals from ‘‘or other entities pursuant to guidance State was not listed? The Wild-to-Wild escaping into the environment), or instructions issued by federal, State, document also created the potential for describe any holding facilities, or local government authorities.’’ The conflicting policies between States. For quarantine procedures, and/or order’s reference to Federal, State, and example, one State could adopt strict veterinarian evaluation involved in the local government authorities has created criteria to ensure that certain safeguards animals’ movement, and explain why an some confusion as to whether any were observed, while a neighboring exemption will not result in the spread Federal or State permit issued before State could have no criteria at all and of monkeypox within the United States. June 11, 2003, constituted ‘‘guidance or decide on wild-to-wild translocations For example, the description of the instructions’’ that would create an on an ad hoc basis. Given these issues animals involved should identify the exception to the order. Through this and potential problems, we have animal(s) and discuss the number of interim final rule, we are clarifying that decided that the written permits in 21 animals involved, their environment, we do not consider all Federal, State, or CFR 1240.63(a)(2)(ii)(B) must be and health conditions. The explanation local government permits as obtained and will no longer observe the of your reasons for seeking an automatically creating an exception to policies expressed in the Wild-to-Wild exemption should show the the prohibitions against transport, sale, document. In other words, all wild-to- justification, including need and etc., because we have no assurance that wild translocations or transportation of benefits, relating to the requested such Federal, State, or local government prairie dogs, other than those that exemption (such as public health permits provide adequate safeguards to occurred before the date of this interim reasons, scientific research, ecological prevent the spread of the monkeypox final rule, will need a written permit reasons, etc.). FDA will grant virus. Therefore, 21 CFR under 21 CFR 1240.63(a)(2)(ii)(B), and exemptions on a case-by-case basis and 1240.63(a)(2)(ii) requires you to obtain the interim final rule supersedes the only for specific purposes and in written permission from FDA to Wild-to-Wild document. specific circumstances. Thus, for capture, offer to capture, transport, offer example, if you receive written to transport, sell, barter, or exchange, 3. What Actions Can FDA Take? (21 permission to transport prairie dogs offer to sell, barter, or exchange, CFR 1240.63(b)) from city A to city B, but you later want distribute, offer to distribute, and/or FDA has limited knowledge as to to move the same prairie dogs to a third release a listed animal into the which kinds of animals in the United location, city C, you would have to seek environment. States may be vulnerable to the written permission to move the prairie We also acknowledge that 21 CFR monkeypox virus, but it is extremely dogs from city B to city C. Depending 1240.63(a)(2)(ii) appears to conflict with difficult, if not impossible, to eradicate on the number and nature of exemption a position that we took on July 2, 2003, a virus once it becomes established in requests it receives, FDA may publish a in a document titled, ‘‘Wild-to-Wild a country or region. For example, the

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West Nile virus was unknown in the or destroying the animal. CDC has for a hearing for purposes of initiating United States before 1999. The virus issued guidance to animal health the hearing under 21 CFR 16.22(a). apparently arrived in the eastern United officials on the disposition of animals Additionally, 21 CFR 1240.63(c)(3) States and quickly spread, via (Refs. 18 and 19). states that the presiding officer will mosquitoes, to domestic bird species, Additionally, there may be instances issue a decision instead of issuing a other animal species (such as horses), where it is difficult to identify an report and a recommended decision as and to humans. In 1999, the virus was animal as belonging to a particular would normally be required under 21 reported in 4 States; by October 2003, 45 species. Some species may resemble CFR 16.60(e) and (f). (Under pre-existing States had reported cases of the West another, and juvenile animals may look FDA regulations, the Commissioner of Nile virus activity in humans or other different from adult animals. Thus, if Food and Drugs may delegate the animals. The virus’s continued spread you capture, offer to capture, transport, authority to an FDA employee to serve in the United States suggests that it is offer to transport, sell, barter, or as the presiding officer (see 21 CFR now permanently established in the exchange, offer to sell, barter, or 16.42(a).) The interim final rule gives United States. exchange, distribute, or offer to the presiding officer the authority to To prevent the monkeypox virus from distribute any rodent, FDA strongly issue a decision so that the agency may spreading and becoming established in advises you to take steps to accurately deal with infected or potentially the United States, 21 CFR 1240.63(b)(1) and reliably identify the species infected animals quickly; otherwise, if authorizes FDA to take the following involved. Accurate and reliable the presiding officer were to issue actions: identification will reduce the potential • reports and recommendations, final Issue an order causing an animal to for disagreements as to whether an action on an animal’s status would be be placed in quarantine. An order animal or group of animals is or should delayed, and this would increase the causing an animal to be placed in be subject to an order and avoid possibility that the animal, if infected, quarantine could extend to kinds of potential, unfortunate instances where could escape or otherwise transmit the animals not named in this interim final animals that cannot be readily identified monkeypox virus to humans or other rule. For example, if a potentially or whose species identification is in animals. infected prairie dog had been in contact dispute are included in an order to FDA has also amended 21 CFR with a ferret, it would be reasonable to cause their destruction. 16.1(b)(2) to add 21 CFR 1240.63 to the quarantine the ferret to ensure that it If a person violates 21 CFR 1240.63, list of regulatory provisions for which a was not infected with the monkeypox that person may be subject to fines, part 16 regulatory hearing is available. virus; imprisonment, and inspections. • Issue an order causing an animal to Penalties for violating the rule are C. What Does CDC’s Rule Say? be destroyed; and discussed in section IV of this 1. Where Is the Rule Codified? (42 CFR • Take other actions as necessary to document. 71.56) prevent the spread of the monkeypox virus. 4. Can You Appeal an Order? (21 CFR The interim final rule creates a new For example, if a pet store were going 1240.63(c)) 42 CFR 71.56 titled, ‘‘African rodents out of business, FDA could, under the If you receive a written order to cause and other animals that may carry the interim final rule, make arrangements an animal to be placed in quarantine or monkeypox virus.’’ with the appropriate Federal, State, to cause an animal to be destroyed, 21 2. What Does the Rule Prohibit? (42 CFR local and tribal authorities to take CFR 1240.63(c) allows you to appeal 71.56(a)) temporary possession of the animals. that order. Your appeal must be in 21 CFR 1240.63(b)(1) also states that writing and be submitted to FDA within 42 CFR 71.56(a) contains only two the authority to issue these orders or to 2 business days after you receive the general prohibitions. In brief, under 42 take any other action is ‘‘in addition to order. As part of your appeal, you may CFR 71.56(a)(1)(i), you must not import any other authorities in this part.’’ The request an informal hearing, and your or offer to import any rodents, whether reference to other authorities includes, appeal must include specific facts dead or alive, that were obtained, for example, 21 CFR 1240.30, which showing there is a genuine and directly or indirectly, from Africa, or allows FDA to take measures to prevent substantial issue of fact that requires a whose native habitat is Africa; any the spread of communicable disease, hearing. For example, if the order was products derived from such rodents, any ‘‘including inspection, fumigation, to cause the destruction of prairie dogs, other animal, whether dead or alive, disinfection, sanitation, pest and you have beavers instead of prairie whose importation the Director of CDC extermination, and destruction of dogs, a genuine and substantial issue of has prohibited by order, or any products animals or articles believed to be fact (i.e., whether you have the animals derived from such animals. This sources of infection.’’ described in the order) would exist. In provision is intended to prevent the FDA will issue all orders in writing. contrast, if the order was to cause the further importation of infected and The order will contain other details, destruction of prairie dogs, and you potentially-infected rodents and such as the animals covered by the simply disagreed with the idea of represents a slight modification from the order, your ability to appeal the order destroying any animal, there would be import restriction that appeared in the (including instructions on filing an no genuine and substantial issue of fact, June 11, 2003, order. The June 11, 2003, appeal), and any other conditions on and FDA would not conduct a hearing order barred importation of ‘‘all rodents quarantine or destruction. FDA officials for your appeal. The interim final rule from Africa.’’ The rule’s import ordinarily will not themselves instructs you to send your appeal to the prohibition is intended to make clear quarantine or destroy an animal. FDA District Director whose office that it covers any rodents that were Instead, FDA officials will order that the issued the order. caught in Africa and then shipped animal be quarantined or destroyed, and If FDA grants your request for an directly to the United States or shipped the individual receiving the order will informal hearing, FDA will follow the to other countries before being imported be responsible for placing the animal in regulatory hearing requirements at 21 to the United States. The prohibition quarantine or having it destroyed and CFR part 16, except that the written also applies to rodents whose native any costs associated with quarantining order will serve as notice of opportunity habitat is in Africa, even if those rodents

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were born elsewhere. For example, 42 permission from CDC to import any these methods can be found in the pox CFR 71.56(a)(1)(i) would apply to a rodents that were obtained, directly or virus material safety data sheet Gambian giant pouched rat even if that indirectly, from Africa, or whose native compiled by Health Canada, http:// animal was born outside Africa. A broad habitat is Africa, or any other kind of www.hc-sc.gc.ca/pphb-dgspsp/msds- import ban on African rodents is animal whose importation the Director ftss/msds160e.html, which states that necessary because there is no quick, has prohibited by order. The interim pox viruses are rendered nonviable by 2 practical method for determining final rule describes the procedures for percent formaldehyde, and heating to ≤ whether a specific animal was born in seeking written permission from CDC 60 °C. Procedures for alkaline and acid a particular geographic region. The and the information that should be inactivation are based on the OIE 2003 import restriction complements efforts submitted with any request and also Terrestrial Animal Code procedures for taken by the U.S. Fish and Wildlife states that the request must be limited food and mouth disease (Article 3.6.2.1) Service to prevent the importation of to scientific, exhibition (such as (http://www.oie.int/eng/normes/MCode/ infected animals (Ref. 20). exhibition of an animal at a zoo), or Al00144.htm). (FDA has verified the Similarly to 21 CFR 1240.63, 42 CFR educational purposes. CDC is limiting Web site address, but FDA is not 71.56 applies to dead animals. Some the request to scientific, exhibition, or responsible for any subsequent changes individuals have attempted to conceal educational purposes because it to the Web site after this document ‘‘bushmeat’’ (a term used to describe recognizes the important contributions publishes in the Federal Register.) meat obtained from animals taken in the that these rodents may make to science, Products derived from African rodents, wild or the ‘‘bush’’) from Federal education, and conservation. CDC will if treated using one of these methods, authorities since the June 11, 2003, respond, in writing, to all requests, and are not subject to the import prohibition order was issued and others have it also may impose conditions in at 42 CFR 71.56(a)(1) and may be attempted to import preserved granting an exemption. If CDC decides imported without written permission specimens of listed species. The against granting written permission, that from CDC. Similarly, fully taxidermied monkeypox virus can remain infectious decision may be appealed by writing to African rodents and completely finished in bushmeat (Refs. 1, 21, and 38), and the CDC official whose office denied the trophies present no disease risk and CDC is unaware of data demonstrating request. The appeal must state the therefore may be imported without the safety of raw or even prepared reasons for the appeal and show there written permission from CDC. Products bushmeat. Preparation methods such as is a genuine and substantial issue of fact imported under the exception in 42 CFR smoking, salting, or brining bushmeat in dispute. CDC will issue a written 71.56(a)(3) are subject to inspection to may slow down bushmeat’s decay, but response to the appeal which will ensure that they do meet the conditions may not render bushmeat free of constitute final agency action. set forth in 42 CFR 71.56(a)(3). infectious agents. Therefore, 42 CFR 42 CFR 71.56(a)(3) represents another 71.56(a)(1) applies to live and dead exemption from the import restrictions. 3. What Actions Can CDC Take? (42 CFR African rodents. Some individuals have asked whether 71.56(b)) 42 CFR 71.56(a)(1)(ii) states that you they could import taxidermied animals To prevent the monkeypox virus from must not prevent or attempt to prevent or animal trophies, while other spreading and becoming established in CDC from causing an animal to be questions have involved products the United States, 42 CFR 71.56(b) gives quarantined, re-exported, or destroyed derived from animals, such as brushes CDC the authority to: pursuant to a written order for that that use animal hair and animal skins. • Issue an order causing an animal to animal’s quarantine, re-export, or Products derived from rodents, such as be placed in quarantine; destruction. (For purposes of this rule, products that use rodent hair, quills, • Issue an order causing an animal to ‘‘quarantine’’ means that the animal is bones, and skins, may contain viable be re-exported; • held or stored in an isolated area, and monkeypox virus if the animal from Issue an order causing an animal to all further movement has been restricted which they are derived was infected be destroyed; or • so as not to expose other animals.) Most with monkeypox. This is based on the Take any other action necessary to individuals will cooperate with a fact that variola virus, a related pox prevent the spread of the monkeypox written order to quarantine, re-export, or virus, has been shown to remain viable virus. destroy an infected animal, but some in proteinaceous exudates for as long as The Director of CDC can also use individuals may attempt to avoid those 1 year (Ref. 22). If these products are other authorities to help prevent the consequences by releasing the animal properly processed to render them spread of monkeypox. For example, instead. Releasing an infected or noninfectious, they pose no disease risk. under 42 CFR 71.32(b), if the Director potentially infected animal would create Such processes would include has reason to believe that there is an a serious risk to animal and human inactivation by: article (including an animal) arriving at health because the monkeypox virus • Heat (heated to an internal a United States port and that article is could then spread to native animal temperature of 70 °C or placed in or may be infected with a species and become established in the boiling water for a communicable disease, the Director may United States. Therefore, if you prevent minimum of 30 minutes); require such actions as detention, or attempt to prevent us from causing an • Preservation in 2 percent disinfection, or other related measures animal to be quarantined, re-exported, formaldehyde; necessary to prevent the introduction, or destroyed, you may be subject to • Chemically treating in acidic or transmission, or spread of criminal penalties. (For more alkaline solutions (soaking in a solution communicable disease. Consequently, information on penalties, section IV of below pH 3.0 or above pH 11.5 for 24 42 CFR 71.56(b) recognizes that the this document.) hours); or Director may use other authorities, and Similarly to 21 CFR 1240.63(a)(2), 42 • The use of hypertonic salts. states that the authority to issue orders CFR 71.56(a)(2) recognizes that there are Vaccinia virus, a related pox virus, was or to take other action is ‘‘in addition to limited circumstances warranting shown to be inactivated after heating in any other authorities under this part.’’ exemptions from some prohibitions. neutral salt buffer solution for 90 Any orders issued by CDC, similar to Consequently, under 42 CFR 71.56(a)(2), minutes at 50 °C or after heating for 60 those issued by FDA, will be in writing an individual may seek written minutes at 55 °C (Ref. 23). Support for and will contain other details, such as

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the animals covered by the order, the FDA will revoke or amend, as animal does not develop monkeypox. If ability to appeal an order, and any other warranted, all or parts of 21 CFR that animal later comes into contact conditions on quarantine, re-export, or 1240.63 if FDA concludes that with prairie dogs, a species which is destruction. CDC officials ordinarily monkeypox is eradicated or adequately already known to be susceptible to will not themselves quarantine, re- controlled so that the virus does not monkeypox, then the prairie dogs could export, or destroy an animal. Instead, become established in the United States. become infected, and another CDC officials will order that the animal FDA’s decision would depend on monkeypox outbreak in prairie dogs be quarantined, re-exported, or scientific principles for controlling could erupt. Again, if studies suggest destroyed, and the individual receiving zoonotic diseases. For example, if the that species can be asymptomatic, but the order will be reponsible for placing incubation period is known, then it still infectious, those results could cause the animal in quarantine or having it re- would be prudent to continue the FDA to recalculate the date on which it exported or destroyed and be restrictions for a time period that is could revoke or amend 21 CFR 1240.6. responsible for any costs associated double the incubation period to ensure F. What Actions Can be Taken to with quarantining, re-exporting, or that there is little further risk of Prevent Outbreaks of Other Zoonotic destroying the animal. CDC has issued infection or restarting the monkeypox Diseases? guidance to animal health officials on outbreak. CDC tests on some animals the disposition of animals. involved in the original April 9, 2003, If another outbreak of a different CDC emphasizes that there may be shipment from Ghana suggest that, zoonotic disease occurred in the United instances where it is difficult to identify insofar as dormice are concerned, the States, we would take actions an animal as belonging to a particular incubation period may be as long as 2.5 comparable to those we have taken to species. Some species may resemble months. If FDA rounds this time frame address monkeypox, modifying those another, and juvenile animals may look up to 3 months, and then doubles the actions as appropriate to the new different from adult animals. Thus, if incubation period, there would appear circumstances. However, we believe you import any rodent, CDC strongly to be little further risk of infection after that the introduction of monkeypox into advises you to take steps to accurately 6 months had passed with no further the United States shows that we need to and reliably identify the species evidence of monkeypox identified, and develop measures to prevent or involved. Accurate and reliable FDA would be able to take actions to minimize the likelihood of other identification will reduce the potential revoke or amend 21 CFR 1240.63. The zoonotic disease introductions or outbreaks. As noted in section IV of this for disagreements as to whether an last infected animal from the April 9, document, section 361 of the PHS Act animal is or should be subject to an 2003, shipment that died from authorizes the Secretary to make and order and avoid potential, unfortunate monkeypox died on July 20, 2003. There enforce such regulations as judged instances where animals that cannot be have been no identified monkeypox necessary to prevent the introduction, readily identified or whose species cases in animals or people in the United transmission, or spread of identification is in dispute are included States since that date. If no further communicable diseases from foreign in an order to cause their destruction. monkeypox cases are identified in the countries into the States or from one United States, and if there is no new 4. Can You Appeal an Order? (42 CFR State to another State. We may regulate information warranting an extension of 71.56(c)) intrastate transactions under this the 6-month time period, FDA intends authority as appropriate (see State of If you received a written order to to revoke or amend 21 CFR 1240.63 as Louisiana v. Mathews, 427 F. Supp. 174 cause an animal to be placed in early as January 20, 2004, which will be (E.D. La. 1977)). We may, therefore, quarantine, re-exported, or destroyed, 6 months after July 20, 2003. At that publish a document in the Federal 42 CFR 71.56(c) explains that you may time, if FDA decided to revoke or Register that would discuss possible appeal that order. Your appeal must be amend 21 CFR 1240.63, it would in writing and be submitted to the CDC regulatory approaches, such as: publish an appropriate document (such • Banning the import into the United official whose office issued the order, as a proposed rule or direct final rule) and you must submit the appeal within States, as well as the capture, sale and in the Federal Register. FDA invites distribution within the United States, of 2 business days after you receive the comments on this approach. order. Your appeal must state the certain categories of: Animals (e.g., reasons for the appeal and show that We emphasize that any possible rodents, marsupials, and bats), or there is a genuine and substantial issue revocation or amendment of 21 CFR animals captured in the wild, or animals of fact in dispute. CDC will issue a 1240.63 may also depend on new data captured in the wild from certain written response to the appeal which or new developments. For example, regions of the world, including regions will constitute final agency action. various animal studies are being within the United States (e.g., prairie conducted to learn more about the dogs in the United States due to their D. When Does the Rule Become incubation period and transmission potential to carry plague or tularemia); Effective? dynamics of monkeypox. If those or For the effective date of the interim studies suggest that the period for • Requiring health certifications and final rule see the DATES section of this incubation and transmission may be subsequent quarantine and health document. longer than 2.5 months, FDA could examination and/or testing prior to decide to recalculate the date on which import or domestic distribution of E. Will We Revoke Or Amend the Rule it might revoke or amend 21 CFR certain categories of animals; or if Monkeypox Is Eradicated in the 1240.63. Studies are also underway to • Requiring assessments of potential United States? determine whether certain species that disease risks prior to import or domestic Monkeypox is endemic in parts of may be infected with the virus, but not distribution of certain categories of Africa. Therefore, we do not anticipate display any symptoms, can infect other animals, with the imposition of revoking the prohibition on import of species. To illustrate how the virus conditions or restrictions depending on African rodents and any other animals could spread from an asymptomatic the level of risk presented. that the Director of CDC has specified animal, assume that an animal can carry If we decide to publish a document in under 42 CFR 71.56(a)(1)(i). However, the monkeypox virus, but that the the Federal Register that addresses the

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broader issues of zoonotic diseases and 3571(c)). In addition, Federal district as amended by the Small Business exotic species, that document will courts have jurisdiction to enjoin Regulatory Flexibility Act (SBREFA), provide an opportunity for public individuals and organizations from requires agencies to analyze regulatory comment on those issues. violating regulations implementing options that would minimize any section 361 of the PHS Act. You should significant economic impact of a rule on IV. What Is the Legal Authority for This also note that if we add more animals small entities. Section 202 of UMRA Rulemaking? under 21 CFR 1240.63(a)(1)(i)(H) or 42 requires that agencies prepare a written Because the public health objective is CFR 71.56(a)(1)(i), any violation statement of anticipated costs and to prevent the spread of communicable involving those additional animals benefits before proposing any rule that disease, we are issuing the rule under would be considered to be a violation of may result in an expenditure by State, section 361 of the Public Health Service a regulation prescribed under section local, and tribal governments in the Act (PHS act) (42 U.S.C. 264). Section 361 of the PHS act. aggregate, or by the private sector, of 361 of the PHS act authorizes the We are proceeding without notice and $100 million in any one year (adjusted Secretary to make and enforce such comment rulemaking because we need annually for inflation). We have regulations as judged necessary to to have regulations in place conducted analyses of the rule, and prevent the introduction, transmission, immediately to address the monkeypox have determined that the rule is or spread of communicable diseases situation. Under the provisions of the consistent with the principles set forth from foreign countries into the States or Administrative Procedure Act at 5 in the Executive Order and in these from one State to another State. We may U.S.C. 553(b)(B), we find for good cause statutes. regulate intrastate transactions under that prior notice and comment on this The interim final rule is not a this authority as appropriate (see State rule are impracticable and contrary to significant regulatory action as defined of Louisiana v. Mathews, 427 F. Supp. the public interest. It is imperative that by the Executive Order. This regulatory 174 (E.D. La. 1977)). we act quickly to clarify and maintain action is also not a major rule under the Section 361 of the PHS act also restrictions on the African rodents, Congressional Review Act. However, the provides for such inspection and prairie dogs, and other animals to Regulatory Flexibility Analysis destruction of articles found to be so prevent the monkeypox virus from concludes that the rule may have a infected or contaminated as to be spreading and becoming established in significant impact on a substantial sources of dangerous infection to the United States. number of small entities. The Unfunded humans, and other measures, as may be Mandates Reform Act does not require V. What Is the Environmental Impact? deemed by the Secretary to be us to prepare a statement of costs and necessary. FDA has determined under 21 CFR benefits for the interim final rule We have invoked section 361 of the 25.32(g) that this action is of a type that because the rule is not expected to PHS act to regulate various activities does not individually or cumulatively result in any one-year expenditure that and articles. FDA has invoked this have a significant effect on the human would exceed $100 million adjusted for authority, for example, to prevent the environment. Therefore, neither an inflation. The current inflation-adjusted transmission of communicable disease environmental assessment nor an statutory threshold is about $110 through certain shellfish, turtles, certain environmental impact statement is million. birds, and human tissue intended for required. transplantation (see 21 CFR 1240.60 In the absence of an applicable A. Objectives and Basis for the Action (molluscan shellfish), 1240.62 (turtles), categorical exclusion, the Director, CDC, Incomplete data preclude us from 1240.65 (psittacine birds), and 1270.1 has determined that provisions developing a quantitative estimate of the through 1270.43 (human tissue)). CDC amending 42 CFR part 70 will not have economic benefits or costs of this rule. has invoked section 361 of the PHS act a significant impact on the human However, we believe that the rule is to control the importation of dogs and environment. This determination is necessary to minimize the risk of cats, turtles, nonhuman primates, consistent with the FDA determination establishing and spreading the etiological agents, and dead bodies (see that the provisions in 21 CFR part 1240 monkeypox virus. The rule formalizes 42 CFR 71.51 through 71.55, are covered by a categorical exclusion. an administrative ban on trade, respectively). CDC has also regulated transport, and import of certain animals VI. What Is the Result of the Analysis the interstate shipment of etiologic and sets forth a process to obtain of Impacts? agents under this authority (see 42 CFR exemptions. In particular, the interim part 72). We have examined the impacts of the final rule prohibits the capture, offer to Section 368 of the PHS act (42 U.S.C. interim final rule under Executive Order capture, transport, offer to transport, 271) provides the authority to enforce 12866, and the Regulatory Flexibility sale, barter, or exchange, offer to sell, section 361 of the PHS act. Under Act (5 U.S.C. 601–612), and under the barter, or exchange, distribution, offer to section 368(a) of the PHS act, any Unfunded Mandates Reform Act distribute, and release into the person who violates a regulation (UMRA) (2 U.S.C. 1501 et seq.). environment of prairie dogs and other prescribed under section 361 of the PHS Executive Order 12866 directs agencies specific animals, and it prohibits act may be punished by imprisonment to assess all costs and benefits of importation of African rodents. The for up to 1 year (42 U.S.C. 271(a)). available regulatory alternatives and, interim final rule supersedes the June Individuals may also be punished for when regulation is necessary, to select 11, 2003, order and allows permits for violating such a regulation by a fine of regulatory approaches that maximize exemptions in cases that pose little risk up to $100,000 per violation if death has net benefits (including potential of establishing or spreading the not resulted from the violation or up to economic, environmental, public health monkeypox virus. $250,000 per violation if death has and safety, and other advantages, resulted (18 U.S.C. 3559, 3571(b)). distributive impacts, and equity). Unless B. The Nature of the Impacts Organizations may be fined up to we certify that the rule is not expected This rule has several impacts. It $200,000 per violation not resulting in to have a significant economic impact continues and clarifies the prohibition death and $500,000 per violation on a substantial number of small of the import of African rodents, as well resulting in death (18 U.S.C. 3559, entities, the Regulatory Flexibility Act, as the capture, offer to capture,

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transport, offer to transport, sale, barter, We invite comment on the economic risks to third parties are not borne by or exchange, offer to sell, barter, or analysis in support of this interim final the owners of infected animals. exchange, distribution, offer to rule. Notwithstanding the inadequacy of distribute, and release into the incentives to control risks associated C. Need for the Rule environment of prairie dogs and other with monkeypox virus, trade in some of specific animals, but allows parties to A new infectious disease, if the animal species affected by this rule apply for exemptions in instances that uncontrolled, can have large adverse fell before any announced government would not pose a risk of establishing or economic effects. It does so because a action. An on-line trading service, spreading the monkeypox virus. Thus, single infection can lead to a few new exoticpets.com, listed on June 13, 2003, importers of small mammals would cases, which in turn can lead to many all of the advertisements to sell prairie have to find animals other than African others. Through this multiplier effect, a dogs that had been posted since May 15, rodents to satisfy market demands for single uncontrolled case of a new 2003. These data, though they represent unusual pets. Firms that supply prairie disease may trigger an epidemic. For advertised prices and not the actual dogs and other listed animals as pets example, West Nile virus, a mosquito- prices of completed transactions at a would be unable to do so and would borne zoonotic disease originally from single website, suggest that the market have to switch to different animals. In Africa, sickened more than four responded very quickly to rumors addition, some animals may be thousand Americans and killed 284 in linking prairie dogs to the monkeypox destroyed if it is determined that such 2002 alone, although it was not outbreak. Five announcements to sell or action is necessary to prevent the recorded in the United States before to buy prairie dogs as pets appeared in further spread of monkeypox in the 1999 (Ref. 24). West Nile virus has also the 7 days beginning May 15, 2003. United States. While we have not affected populations of many Three more advertisements appeared in generated quantitative estimates of the indigenous species of birds and the 7 days starting May 22, 2003, and magnitude of these effects, available mammals. Existing economic incentives ending May 28, 2003, with the very last evidence suggests that they are to control such risks are generally announcement posted on May 27, 2003. relatively small. inadequate because the costs of such BILLING CODE 4160–01–S

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BILLING CODE 4160–01–C

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The prairie dog trading market then D. Baseline negligible because permits would be seemed to vanish, even before the Economic analysis of a regulatory granted only in instances where earliest report linking prairie dogs to the action requires as a first step the prohibited activities pose minimal risk outbreak of monkeypox. On June 6, identification of a baseline, a depiction of establishing or spreading the 2003, one day before any announcement of the world in the absence of any monkeypox virus. by CDC, Wisconsin health officials action, from which to calculate the E. Alternatives banned the sale, importation, and effects of the regulations. The baseline Sound economic analysis requires an display of prairie dogs because of for this rule is complicated by at least human disease outbreak associated with assessment of reasonable alternatives. two issues. First, as noted, news of the The key alternative, and one on which animal-borne transmission (Ref. 25). epidemic has curtailed trade in advance Three notices mentioning the illness we solicit comment, is a ‘‘sunset’’ of Federal action. Buyers and sellers do provision ending the domestic and the restrictions on trade appear at not want to trade animals that may be exoticpets.com in lieu of advertisements restrictions by January, 2004, unless we infected with a virus that can make made a determination that the ban was on June 8 and 9, 2003. No subsequent people sick. To distinguish between the announcements or advertisements necessary to protect health and safety. effects of our actions to ban trade in The economic advantage of this appear on the website. These data, certain animals and the effects of summarized in Figure 1, suggest that the alternative relative to this interim final monkeypox on such trade, this analysis rule may be the elimination of market reactions to risks of uses as a baseline the current state of contaminated pets may have already permitting costs for capturing, affairs; that is, it recognizes that the transporting, selling, bartering, curtailed most, if not all, of the retail outbreak is ongoing and that the market trade.1 Statistical testing of the prairie exchanging, distributing, or releasing an has responded. animal that has been only a conduit and dog advertisement appearance rates An administrative order issued by before and after the CDC announcement not a source of infection, as well as FDA and CDC on June 11, 2003, and allowing for resumption of a prairie dog shows a 99.3 percent chance that there intended to manage the same risks as was a real change in the daily market as existed before the disease. It this interim final rule also complicates may, however, provide for later capture, advertisement appearance rate (i.e., the efforts to identify a baseline. We rate difference is very likely not the transport, sale, barter, exchange, propose to use two baselines to provide distribution, or release of an animal that result of mere chance).2 According to full information about the effects of our the prices listed in classified may carry other diseases. actions. First, we assume that there is no We also considered whether it would advertisements posted at administrative order, and second, we be possible to devise a regulatory exoticpets.com, neither the markets for assume that the baseline includes the program that would allow for testing other pets, such as rabbits, nor the June 11, 2003, order. and certification of animals, whereby frequency of such advertisements, have With the second baseline there are no animals that had been certified to be been affected. costs and no benefits because the free of the monkeypox virus would not While the market has responded interim rule formalizes and clarifies the be subject to the rule’s prohibitions. We quickly to the outbreak, it is also June 11, 2003, order, with the important did not pursue this alternative because important to note that the market exception of a new procedure for studies are being conducted to enabled the outbreak to occur in the first Federal permits allowing people to determine the incubation period in place. With less vigilant public health import, capture, offer to capture, various animal species and the manner surveillance, or with private parties that transport, offer to transport, sell, barter, in which the virus may be transmitted. were less cooperative or less or exchange, offer to sell, barter, or In other words, scientific knowledge responsible, infected prairie dogs could exchange, distribute, offer to distribute, about monkeypox is still evolving, so it have been distributed more broadly in and release into the environment prairie may be unlikely that a quick, reliable commerce, posing greater disease risks. dogs and other specific animals when it testing method, particularly when In addition, infected prairie dogs might otherwise would be prohibited. Relative incubation periods and the extent to have been released into the wild, posing to the outright prohibition in the June which animals may be asymptomatic large risks to native mammals and, 11, 2003, order, permits would lower carriers of the monkeypox virus are through them, to humans. This rule costs to parties seeking to import, unknown, will be developed in the would minimize the risks that such capture, offer to capture, transport, offer immediate future. events could occur by requiring permits to transport, sell, barter, or exchange, Assessment of other alternatives is if individuals capture, transport, sell, offer to sell, barter, or exchange, limited because the interim final rule barter, exchange, distribute, or release distribute, offer to distribute, and would allow exceptions to the animals that have been implicated in release into the environment listed prohibited activities provided that the monkeypox outbreak. animals. For example, zoos and related parties have Federal permits. The animal facilities, prairie dog relocation specific criteria for these exceptions 1 Figure 1 excludes one advertisement because it services, and research labs may request have not been determined, but can be was a solicitation to buy without reference to price. permission to import, capture, transport, 2 From May 15, 2003, through May 28, 2003 (14 expected to include those activities that days inclusive), there were 8 days when or sell listed animals, and, if permission pose no risk of establishing or spreading advertisements for prairie dogs appeared at the web is granted, they may continue such the monkeypox virus. site for exoticpets.com. Thus, on about 57 percent activities that would otherwise be (8/14=0.571) of the days, prairie dog advertisements prohibited by the June 11, 2003, order. F. Benefits appeared. From May 29, 2003 through June 6, 2003 (9 days inclusive), there were no (zero) days when Generating quantitative estimates of the A recent report indicates that 71 cases prairie dog advertisements appeared. According to cost savings from such permits is not of monkeypox in humans have been Fisher’s Exact Test, the probability that these two possible because of the uncertainty reported in Illinois, Indiana, Kansas, statistics came from the same distribution is 0.0072. associated with how and when such Ohio, Missouri, and Wisconsin (Ref. 4). In other words, we are 99.3 percent certain that there was a change in the daily appearance of permits would be granted. While these Detailed clinical information was prairie dog advertisements between these two time exemptions may in principle pose some available for 30 cases reported in Illinois periods. risks, we believe that these are and Wisconsin. Among these, the

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earliest reported onset of illness was on spontaneously, but the owner of that relatively constant, with sales and May 15, 2003. For the majority of rabbit became ill with a disease prices slightly down since Japan, the patients (22 (73 percent)), a febrile compatible with the clinical description largest foreign market, banned illness has either preceded or of monkeypox; however, the rabbit importation of prairie dogs on March 1, accompanied the onset of a papular owner was not a laboratory-confirmed 2003. rash; respiratory symptoms (16 (64 case (Ref. 28). This rule would reduce Typically, pet stores purchase prairie percent)), lymphadenopathy (14 (47 the risk of the monkeypox virus dogs from dealers for $50 to $60 each, percent)), and sore throat (10 (33 spreading among both species known to and re-sell to pet owners for about $150 percent)) also were prominent signs and carry it, as well as the possibility of it each (Ref. 32). If average retail prices of symptoms. The rash typically spreading through wild and pet species prairie dogs were $150 prior to the progressed through stages of currently not known to carry it. monkeypox outbreak, annual prairie dog vesiculation, pustulation, umbilication, Because this interim final rule would sales in the pet market would appear to and encrustation. Early lesions became be expected to reduce the frequency of be $4.5 million, although this estimate ulcerated in some patients. Rash monkeypox outbreaks, there would also must be seen as very approximate distribution and lesions have occurred be a commensurate reduction in because it is based on a market survey. on the head, trunk, and extremities; outbreak traceback efforts by the Federal A ban on the capture, transport, sale, many patients had initial and satellite Government, as well as possible state barter, exchange, distribution, or release lesions on palms, soles, and extremities. and local government efforts. The costs of prairie dogs would have a noticeable Rashes were generalized in some of these traceback efforts would vary effect on prairie dog trappers who patients. No fatalities have yet been depending on the size of the outbreak. supply the pet market, if it occurred in reported in the United States although G. Costs the absence of an outbreak. Prairie dog the case fatality rate in remote and trappers would not be expected to incur The costs of this interim rule are the medically underserved areas of Africa is serious economic effects this year lost value to consumers and producers between 1 percent and 10 percent (Ref. because the peak of the prairie dog sales associated with not being able to import, 26). season (April through June 1) has capture, transport, sell, barter, exchange, We lack data to estimate the value in passed (Ref. 32). A permanent distribute, or release prairie dogs and monetary terms that people might assign prohibition on transportation of prairie certain African rodents. We believe that to specific reductions in the risk of dogs, however, could have a very the costs are not likely to be high, monkeypox infections. serious effect. Suppliers of pet supplies because the monkeypox outbreak has This rule would also reduce the risk and equipment intended for prairie dogs already sharply curtailed the trade in to public health that would result if and the other small, listed rodents may prairie dogs, as described above. This monkeypox became endemic in the also be affected by this action, but we United States. (An ‘‘endemic’’ disease is curtailment occurred prior to Federal believe such effects will be small one that is confined to or characteristic regulatory action. Unfortunately, we because this equipment may also be of a particular locality.) The potential lack data on the magnitude of trade that suitable for some other mammalian pets, risks to humans from exposure to has occurred since the outbreak was such as hamsters or guinea pigs. monkeypox established among wild publicized in June, and so we present A variety of relocation activities animal populations would be instead data from before the outbreak. involving prairie dogs are undertaken in potentially large if the disease were not These data overstate the costs of the rule part because the Federal Fish and controlled. Inadvertent contact between insofar as they ignore the reduction in Wildlife Service has assigned at least infected pets and wild animals could volume of trade likely already to have one prairie dog species a status of spread monkeypox into established wild resulted from the outbreak itself. animal populations, causing widespread Indeed, if the data shown in Figure 1 are ‘‘warranted’’ under the Endangered disruption to ecosystems and representative of broader and long- Species Act. Many of these activities potentially exposing large numbers of lasting market conditions, then the already require permits from State people to a new infectious agent. In interim final rule’s prohibition has no agencies (Ref. 33). We lack information Africa, serologic evidence of impact on sales of prairie dogs as pets on the scope or magnitude of such monkeypox infection has been found in because trade has vanished as a result activities or how they might be affected a wide variety of nonhuman primates, of the outbreak. If the trade in prairie by the June 11, 2003, order or by this rodents, and squirrels; monkeypox virus dogs would otherwise have resumed in rule, but would expect some of them to has been isolated from a species of the absence of this order, then costs qualify for exemptions. squirrel in Zaire, but the role of any would occur. Although we do not have Another category of trade affected by particular species as a reservoir has not trade data for the other listed animals this rule is zoos, which routinely trade been established. Some species of during the same periods, we surmise animals for a variety of purposes, primates, rodents, and lagomorphs that similar reductions in trade of these although we lack information about the (such as rabbits) are known to be animals has also occurred. extent of trade in prairie dogs or African susceptible. Although no infections Generally, the trade in prairie dogs rodents. The American Zoo and have been previously reported in dogs falls into several categories. In terms of Aquarium Association (AZA) is the or cats, these species may also be volume, the largest category with the largest zoo and aquarium organization susceptible to monkeypox (Ref. 27). greatest number of animals traded in the world. The AZA’s mission is to Thus, there is significant risk that involves the market for pets. There are establish, uphold, and raise the highest common, native mammalian species, currently about 10 to 15 million prairie zoological and aquarium industry such as squirrels and rabbits, could dogs in the United States (Ref. 29). In standards. It has accredited over 200 become reservoirs of this new disease if 2001, 30,000 prairie dogs were sold for organizations, of which about 170 are it were released into the environment. pets (Ref. 30). About 15,000 of the zoos in the United States. As of June 6, CDC has reported that a pet rabbit 30,000 sold were captured in Texas by 2003, about 79 zoos in the United States treated at a veterinary clinic that also registered dealers (Ref. 31). Some 15,000 held 758 prairie dogs according to a had an infected prairie dog became ill are exported annually (Ref. 29). Sales survey of data at the website for the and died. The rabbit died over the last few years have remained International Species Information

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System.3 We recognize that AZA has an conservation efforts. These requests are rodents, trappers and distributors of accreditation process for institutions estimated to take 2 hours to complete. prairie dogs, other small animal such as zoological parks, and a separate We cannot confidently estimate an distributors, as well as retail pet stores. certification process for related average wage for those seeking The Small Business Administration facilities, such as wildlife refuges, permission to transport listed animals, (SBA) sets criteria by which it qualifies conservation research facilities, survival but at a total annual burden of about 120 businesses as small entities. The SBA or rehabilitation centers, breeding farms, hours, we would expect the total cost limit for small pet and pet supply stores and educational organizations (Ref. 34). burden to range from $3,000 to $6,000. is $6 million in revenues. Census AZA accreditation requires that FDA resource costs to process and Bureau data shows that about 6,500 institutions follow the guidelines of the respond to each request are estimated to retail pet store companies operate about American Association of Zoo total about 6 hours distributed across 8,300 establishments in the United Veterinarians regarding medical various staff levels. We estimate that the States. A substantial number of these programs and zoo hospitals. average pay level of these staff positions firms (about 94%) have a single Data on the sale and imports of the at about $37 per hour. The establishment with average annual other rodents that would be prohibited administrative effort to process these revenues of about $356,000, thereby with this interim rule are limited. Data requests would result in about $13,300 qualifying them as small businesses. We from the U.S. International Trade (60 requests x 6 hours per request x $37 believe it is unlikely that the total sales Commission show that about $38,000 per hour = $13,320) in costs to FDA. of all of the listed animals would worth of live African animals that could Similar costs would be incurred by represent a significant portion of total reasonably be expected to include these those that would request written pet store sales. However, due to the lack specific rodents were imported into the permission from CDC to import a listed of data on total sales of these animals, United States in 2002. Information from animal. We estimate that CDC would as well as the possibility that some pet the Fish and Wildlife Service indicates receive about 12 requests annually, stores may specialize in the small that, in 2002, nearly 8,000 African resulting in a cost burden of about $500 animals that are listed in this rule, we rodents were imported into the United to these individuals. CDC would also be cannot rule out the possibility that the States. We do not have information that expected to incur administrative costs to rule may have a significant impact on a confirms that these separate database process and respond to these requests substantial number of these small measurements relate to the same that would be similar to those incurred entities. animals, but suggest that African rodent by FDA. We estimate that those costs The SBA limit for small business imports appear to be relatively small. may total to about $3,000. qualification for trappers is $3.5 million Retail sales of such animals as pets This interim final rule may result in or less in revenues. Prairie dog trappers, would be expected to be somewhat the quarantine and/or destruction of an as described previously, would surely higher than the value shown above due unknown number of listed animals if we qualify as small businesses under this to retailer price markups. Further, we determine that such action is necessary definition (Ref. 32). For at least some of are unable to confidently estimate the to prevent the further spread of these trappers, the loss of their profits number of other listed animals (except monkeypox in the United States. We do from the effects of this rule would likely for prairie dogs) from either domestic or not have an estimate of the marginal represent a significant impact on their imported origin that are sold each year cost to quarantine, destroy or dispose of businesses. as pets in the United States. A recent an individual animal. Further, the The SBA limit for all small business American Pet Products Manufacturers uncertainty surrounding the total wholesale activities is set at 100 Association survey does not list any of number of animals that would be employees. We lack the data to the animals listed in this interim final affected by this provision of the rule determine the extent to which rule in its section on small animals (Ref. makes it difficult to estimate a total cost wholesalers and distributors of all small 35). Accordingly, we conclude that the for such circumstances. We believe that animals listed in this interim final rule number of such animals is relatively facilities for such purposes are available (including those that import animals small. and would not be expected to impose and those that handle domestic animals) The interim final rule would allow for substantial costs to the Government. would be affected by this rule. That being the case, we allow for the persons wishing to seek exemptions 1. Regulatory Flexibility Analysis from the rule’s prohibitions by possibility that a substantial number of The Regulatory Flexibility Act requesting written permission from FDA those that are affected may be small requires agencies to examine regulatory or CDC. We have tentatively estimated entities, and in some instances may alternatives for small entities if that rule that about 60 such requests would be incur significant impacts due to this may have a significant impact on a made annually to FDA. We would rule. substantial number of small entities. We request public comment on the expect these requests to be made by a. Objective of the rule. The size and structure of those firms or animal relocation specialists or others implementation of this interim final rule persons involved in the trade of all involved in biological research or would ensure the safety of the human animals listed in this interim final rule and animal populations in the United 3 The International Species Information System and the rule’s effects on such firms and (ISIS) maintains a computer-based information States from the monkeypox virus. The persons. The incompleteness of data, as system for wild animal species held in captivity. objective of this interim final rule is to described previously, precludes us from The database contains information on ten thousand reduce the risk to public health from the developing quantitative estimates of the species held in 586 institutions in 72 countries on spread of the monkeypox virus 6 continents. Roughly 250 of these institutions are costs of this rule for each type of small professionally managed United States zoos, most of throughout the United States. entity. which have been accredited by AZA. The ISIS Web b. Small entity definitions and site allows web-based searches by species and is impacts. A regulatory flexibility 2. Analysis of Alternatives updated weekly (see International Species analysis (RFA) is required to estimate As stated previously, one alternative Information System (ISIS); conversation with Mr. Nate Flesness, ISIS director; ISIS Web site the number of small entities to which is a ‘‘sunset’’ provision ending the information (www.ISIS.org)). ISIS is located in the interim final rule would apply. This prohibitions on prairie dogs or other Apple Valley, Minnesota. rule would affect importers of African animals at some point in the future,

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unless we determine that the ban was 3501–3520). A description of these imported from Africa. Further necessary to protect health and safety. provisions is given below with an transmission of the virus likely occurred The economic advantage of this estimate of the annual reporting burden. in the storage and handling of these alternative relative to this interim final Included in the estimate is the time for rodents during sale and distribution rule may be the elimination of reviewing instructions, searching within the United States. This resulted permitting costs for transport in existing data sources, gathering and in secondary transmission to domestic domestic animals in the case that maintaining the data needed, and prairie dogs in this country housed in monkeypox has not become endemic. It completing and reviewing each the same animal-holding facility or pet may, again, provide for later capture, collection of information. shop. Introduction of exotic species, transport, sale, barter, exchange, Both FDA and CDC have requested such as African rodents, poses a serious distribution, or release of an animal that emergency processing of this proposed public health threat because of the may carry other diseases. This collection of information under section potential of human monkeypox virus alternative was not accepted because of 3507(j) of the PRA (44 U.S.C. 3507(j) infection. Transport, sale, or any other the uncertainty in predicting when a and 5 CFR 1320.13). Such emergency type of distribution, including release ban would no longer be necessary. processing is necessary in order to into the environment, of certain species A second alternative would have been respond immediately to the monkeypox of rodents poses a serious public health to allow the continued capture, outbreak. This interim final rule, at 21 threat because of the potential for transport, sale, barter, exchange, CFR 1240.63(a)(2)(ii)(A) and (B) and 42 further spread of the monkeypox virus distribution, or release of the listed CFR 71.56(a)(2)(i) and (ii), contains to other animal species and to humans. animals, effectively doing nothing to information collection requirements. In To prevent the establishment and reduce the risk of further spread of compliance with the PRA (44 U.S.C. spread of the monkeypox virus in the monkeypox. Although the market for at 3507(d)), we have submitted a copy of United States, we are prohibiting the least prairie dogs was apparently greatly the information collection provisions of capture, offer to capture, transport, offer reduced due to public knowledge of the this interim final rule to OMB for to transport, sale, barter, or exchange, monkeypox issue and seasonal variation review. offer to sell, barter, or exchange, The information collections in this in the prairie dog market, this option distribution, offer to distribute, or interim final rule have been approved would have allowed those few in the release into the environment of prairie under OMB control number 0910–0519 market that dismissed the severity of the dogs and certain rodents and any other (for 21 CFR 1240.63) and OMB control problem to continue to pose a risk that animal so prohibited by order of the number 0920–0615 (for 42 CFR 71.56). monkeypox would become endemic to Commissioner of Food and Drugs. We An agency may not conduct or sponsor domestic pets and wildlife and further are also prohibiting the importation of and a person is not required to respond affect human health. For this reason it all rodents that were obtained, directly to a collection of information unless it was determined to be not acceptable. or indirectly, from Africa, or whose A third alternative would have been contains a currently valid OMB control native habitat is Africa, or any other to exempt small businesses from this number. animal whose importation the Director interim final rule. However, because Title: Control of Communicable of CDC has prohibited by order. The about 94 percent of pet stores and Diseases; Requests for Exemptions from rule provides for exemptions from these probably a large portion of small animal the Restrictions on African Rodents, prohibitions and discusses our authority trappers and wholesalers/distributors Prairie Dogs, and Certain Other to issue orders causing an animal to be are small businesses, this option would Animals. quarantined, re-exported, or destroyed. have compromised the rule’s ability to Description: Monkeypox is a rare The information collection burden is reduce the risk of establishing or zoonotic viral disease that occurs associated with the process for seeking spreading the monkeypox virus in the primarily in the rain forest countries of an exemption. United States. central and west Africa. Studies have shown that infected rodents are capable Description of Respondents: Persons VII. Paperwork Reduction Act of 1995 of transmitting the monkeypox virus to who capture, offer to capture, transport, This interim final rule contains humans. Limited person-to-person offer to transport, sell, barter, or information collections that are subject spread of infection has been reported in exchange, offer to sell, barter, or to review by the Office of Management disease-endemic areas in Africa. It is exchange, distribute, offer to distribute, and Budget (OMB) under the Paperwork likely the virus is entering the United import, offer to import, or release into Reduction Act of 1995 (PRA) (44 U.S.C. States by way of rodent species the environment certain rodents.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Annual Frequency Total No. of Hours per CFR Section No. of Respondents per Response Responses Response Total Hours

21 CFR 1240.63(a)(2)(ii)(A) and (B) 60 1 60 2 120

42 CFR 71.56(a)(2)(i) and (ii) 12 1 12 0.5–1.0 10

Total 130 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Our estimates are based on our number of respondents, we examined fewer than 10 requests, and most experience to date with the June 11, the number of requests and inquiries we requests involved requests to move an 2003, order and on similar requests have received since the June 11, 2003, animal from one location to another. under FDA regulations. To estimate the order. Both FDA and CDC have received (FDA also has received many inquiries.)

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As we cannot predict how the some States have issued orders with 5. State of Colorado, Wildlife Commission, monkeypox outbreak will be resolved, restrictions that cover fewer animal ‘‘Emergency Regulation,’’ dated July 10, we will tentatively estimate that there species, those State requirements do not 2003. will be 60 respondents for FDA’s conflict with the interim final rule and 6. State of Illinois, ‘‘Executive Order in Response to Orthopox Outbreak,’’ dated June provisions and 10 respondents for would also not be superseded. However, 7, 2003. CDC’s provisions. Furthermore, based in accordance with section 361(e) of the 7. State of Indiana, Board of Animal on FDA’s experience with submissions PHS act, any State or local law that Health, Emergency Rule, dated June 9, 2003. seeking exemptions or waivers, we will would permit any activity prohibited 8. State of Michigan, Department of tentatively estimate that each under this interim final rule would be Community Health, ‘‘Order Finding respondent will need 2 hours to in conflict with this rule and, therefore, Imminent Danger to the Public Health and complete its request for an exemption. would be superseded. Requiring Corrective Action,’’ dated June 13, Therefore, the total reporting burden We note that we have been in direct 2003, and later amended on June 27, 2003. under 21 CFR 1240.63(a)(2)(ii)(A) and contact with many States regarding the 9. State of North Dakota, State Board of June 11, 2003, order and efforts to Animal Health, ‘‘In the matter of: Monkeypox (B) will be 120 hours (60 respondents x in Prairie Dogs and Gambian Giant pouched 2 hours per response = 120 hours). prevent the spread of monkeypox. We Rats,’’ Order No. 2003–04, dated June 11, CDC’s estimates for the burden of its believe that the public health requires 2003. data collection are based on its us to give this regulation immediate 10. State of Wisconsin, Department of experience with the importation of non- effect. Through this interim final rule, Agriculture, Trade, and Consumer Protection, human primates. CDC estimates that and under to section 4(e) of Executive ‘‘Emergency Rule,’’ dated June 9, 2003. there will be 12 respondents annually Order 13132, we are providing all 11. State of Wisconsin, Department of for this data collection. Respondents affected State, local, and tribal officials Health and Family Services, ‘‘Emergency will include individuals, businesses, notice and opportunity to participate in Order - June 12, 2003,’’ dated June 12, 2003. and organizations. Although CDC this rulemaking. 12. Order dated June 11, 2003, signed by Julie Louise Gerberding, Director, Centers for estimates that most respondents will IX. Comments Disease Control and Prevention, and Mark B. submit only one request per year, CDC McClellan, Commissioner of Food and Drugs, feels that organizations may submit 2 Interested persons may submit to the titled ‘‘Joint Order of the Centers for Disease requests per year. Individuals and Division of Dockets Management (see Control and Prevention and the Food and businesses submitting requests will ADDRESSES) written or electronic Drug Administration, Department of Health need 30 minutes to prepare the request. comments regarding this document. and Human Services.≥ Organizations will need 1 hour to Submit a single copy of electronic 13. 68 FR 36566, June 18, 2003. prepare an initial request and 10 comments or two paper copies of any 14. Centers for Disease Control and minutes for subsequent requests. The mailed comments, except that Prevention, ‘‘Update: Multistate Outbreak of total annualized burden under 42 CFR individuals may submit one paper copy. Monkeypox— Illinois, Indiana, Kansas, Comments are to be identified with the Missouri, Ohio, and Wisconsin, 2003,’’ 71.56(a)(2)(i) and (ii) will be 10 hours. Morbidity and Mortality Weekly Report, 52: The requirements contained in 21 docket number found in brackets in the 616–618, July 4, 2003, (describing how CFR 1240.63(c) and 42 CFR 71.56(c) are heading of this document. Received animal laboratory testing demonstrated that a not subject to review by OMB because comments may be seen in the Division Gambian giant pouched rat, three dormice, they are exempted under 5 CFR of Dockets Management between 9 a.m. and two rope squirrels from an April 9, 2003, § 1320(a)(4), which exempts and 4 p.m., Monday through Friday. shipment of animals from Ghana were ‘‘administrative actions * * * involving infected with the monkeypox virus). X. References an agency against specific individuals or 15. North Carolina Department of Health entities.’’ The following references have been and Human Services, ‘‘State Health Official placed on display in the Division of Reminds Public Not to Release Prairie Dogs VIII. Federalism Dockets Management and may be seen Into the Wild,’’ dated June 19, 2003. We have analyzed this interim final by interestes persons between 9 a.m. 16. Colorado Division of Wildlife, rule in accordance with the principles ‘‘Wildlife Report: Black-Footed Ferrets Back and 4 p.m., Monday through Friday. in Colorado,’’ dated November 19, 2001 set forth in Executive Order 13132 and 1. Khodakevich, L., Jezek, Z. and (available at www.dnr.state.co.us/cdrlnews/ Messinger, D., ‘‘Monkeypox Virus: Ecology have determined that the rule has wildlife/2001111985112.htm). and Public Health Significance,’’ Bulletin of federalism implications. Federal 17. Food and Drug Administration and the World Health Organization, 66: 747–752, restrictions on the capture, offering to Centers for Disease Control and Prevention, 1988. This reference identifies several ‘‘Wild-to-Wild Translocation or capture, transport, offering to transport, species of squirrels as playing a major role as sale, barter, or exchange, or offering to a reservoir for the monkeypox virus. Transportation of Prairie Dogs’’ (undated). sell, barter, or exchange, distribution, 2. Centers for Disease Control and 18. Centers for Disease Control and offering to distribute, or release into the Prevention, ‘‘Updated Interim Case Prevention, ‘‘Interim Guidance to State and environment of certain rodents and Definition for Human Case of Monkeypox,’’ Local Governments for the Removal of State- and Locally Imposed Quarantine Orders and prairie dogs are both necessary and dated July 2, 2003 (available through www.cdc.gov/ncidod/monkeypox). FDA has the Euthanasia of Animals Affected by the appropriate to prevent the establishment Monkeypox Outbreak,’’ dated July 1, 2003. and spread of monkeypox virus in the verified the Web site addresses in this document, but FDA is not responsible for any 19. Centers for Disease Control and United States. In accordance with subsequent changes to the Web site after this Prevention, ‘‘Questions and Answers: section 361(e) of the PHS act (42 U.S.C. document publishes in the Federal Register. Quarantine and Euthanasia of Animals 264(e)), nothing in this interim final rule 3. Centers for Disease Control and Affected by the Monkeypox Outbreak,’’ dated supersedes any provisions of State or Prevention, ‘‘Questions and Answers About July 10, 2003. local law except to the extent that such Monkeypox,’’ dated July 7, 2003 (available 20. Fish and Wildlife Service, ‘‘Notice to a provision conflicts with this interim through www.cdc.gov/ncidod/monkeypox). the Wildlife Import/Export Community,’’ dated June 11, 2003 (describing import and final rule. For example, the interim final 4. Centers for Disease Control and Prevention, ‘‘Update: Multistate Outbreak of export prohibitions on certain rodents, rule does not prevent a State from taking Monkeypox—Illinois, Indiana, Kansas, including any rodents from Africa, whether stronger measures to deal with infected Missouri, Ohio, and Wisconsin, 2003,’’ alive or dead, for any purpose). or possibly infected animals or to cover Morbidity and Mortality Weekly Report, 52: 21. Peeters, M., et al., ‘‘Risk to Human additional species. Furthermore, while 642–646 (July 11, 2003) Health from a Plethora of Simian

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Immunodeficiency Viruses in Primate 21 CFR Part 1240 (B) African Tree squirrels Bushmeat,’’ Emerging Infectious Diseases, 8: Communicable diseases, Public (Helioscirurus sp.), 451–457 (May, 2002) (showing that humans (C) Rope squirrels (Funisciurus sp.), health, Travel restrictions, Water who hunt and handle bushmeat are exposed (D) African Dormice (Graphiurus sp.), to many viruses). supply. (E) Gambian giant pouched rats 22. Downie, A.W., and Dumbell, K. R., 42 CFR Part 71 (Cricetomys sp.), ‘‘Survey of Variola Virus in Dried Exudate (F) Brush-tailed porcupines and Crusts from Smallpox Patients,’’ Lancet, Airports, Animals, Communicable (Atherurus sp.), 1: 550–3, 1947. diseases, Harbors, Imports, Pesticides (G) Striped mice (Hybomys sp.), or 23. Woodruffe, G. M., ‘‘The Heat and pests, Public health, Quarantine, Inactivation of Vaccinia Virus,’’ Virology, 10: (H) Any other animal so prohibited by Reporting and recordkeeping order of the Commissioner of Food and 379–82 (1960). requirements. 24. http://www.cdc.gov/od/oc/media/ Drugs because of that animal’s potential ■ wncount.htm. Therefore, under the Public Health to transmit the monkeypox virus; and 25. Wisconsin Division of Public Health, Service Act and under authority (ii) You must not prevent, or attempt Press Release: ‘‘6/6/03, Wisconsin Division of delegated to the Commissioner of Food to prevent, the Food and Drug Public Health Bans Sale of Prairie Dogs.≥ and Drugs and to the Director, Centers for Administration (FDA) from causing an 26. Centers for Disease Control and Disease Control and Prevention, 21 CFR animal to be quarantined or destroyed Prevention, ‘‘Multistate Outbreak of parts 16 and 1240 and 42 CFR part 71 are under a written order for the animal’s Monkeypox - Illinois, Indiana and amended as follows: quarantine or destruction. Wisconsin,’’ Morbidity and Mortality Weekly 21 CFR CHAPTER I (2) The prohibitions in paragraph Report, 52: 537–540, June 13, 2003. (a)(1) of this section do not apply if you: 27. Centers for Disease Control and (i) Transport an animal listed in Prevention, ‘‘Monkypox Infections in PART 16—REGULATORY HEARING Animals: Updated Interim Guidance for BEFORE THE FOOD AND DRUG paragraph (a)(1) of this section, or Veterinarians,’’ dated July 22, 2003 (available ADMINISTRATION covered by an order by the through http://www.cdc.gov/ncidod/ Commissioner of Food and Drugs, to monkeypox/pdf/mpoxanimalguidance.pdf). ■ 1. The authority citation for 21 CFR veterinarians or animal control officials 28. Centers for Disease Control and Part 16 continues to read as follows: for veterinary care, quarantine, or Prevention, ‘‘CDC Telebriefing Transcript: Authority: 15 U.S.C. 1451–1461; 21 U.S.C. destruction purposes; or Monkeypox Investigation,’’ dated June 7, 141–149, 321–394, 467f, 679, 821, 1034; 28 (ii) Have written permission from 2003 (available through http://www.cdc.gov/ U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364. FDA to capture, offer to capture, od/oc/media/transcripts/t030607.htm). ■ 2. Section 16.1 is amended in transport, offer to transport, sell, barter, 29. Data Source: ‘‘Pet Your Prairie Dog,’’ or exchange, offer to sell, barter, or Wall Street Journal, posted April 24, 2003. paragraph (b)(2) by numerically adding exchange, distribute, offer to distribute, This article can be found at http:// an entry for § 1240.63(c)(3) to read as www.twincities.com/mld/twincities/living/ follows: and/or release into the environment an 5698532.htm. animal listed in paragraph (a)(1) of this 30. Data Source: http:// § 16.1 Scope. section, or covered by an order by the www.prairiedog.info/ * * * * * Commissioner of Food and Drugs. You prairieldoglreintroduction.htm. (b) * * * may not seek written permission to sell, 31. Robert E Pierre, ‘‘Newfound Scrutiny (2) * * * barter, or exchange, or offer to sell, for a Pest to Some, a Beloved Pet to Others,’’ § 1240.63(c)(3), relating to a written barter, or exchange, as a pet, an animal Washington Post, June 11, 2003. Page A–03. order to cause an animal to be placed in listed in paragraph (a)(1) of this section 32. Phone conversation with prairie dog or covered by an order by the trapper in Lubbock, Texas, on June 16, 2003. quarantine or to cause an animal to be 33. U.S. Fish and Wildlife Service, destroyed. Commissioner of Food and Drugs. (A) To obtain such written permission Mountain-Prairie Region, ‘‘Black Tailed * * * * * Prairie Dog-The Black-tailed Prairie Dog from FDA, you must send a written Conservation Assessment and Strategy,’’ PART 1240—CONTROL OF request to the Division of Compliance dated September 9, 1999 (available through COMMUNICABLE DISEASES (HFV–230), Center for Veterinary http://www.r6.fws.gov/btprairiedog/ Medicine, Food and Drug conassstrat.htm#strategy). ■ 3. The authority citation for 21 CFR Administration, 7500 Standish Pl., 34. http://www.aza.org/Accreditation/#acc. part 1240 continues to read as follows: Rockville, MD 20855, Attn: Listed 35. 2003 2004 QPPMA National Pet Animal Permit Official. You may also Owners Survey, American Pet Product Authority: 42 U.S.C. 216, 243, 264, 271. 36. Axtman, K., ‘‘The Prairie Dog: Pest or ■ 4. Section 1240.63 is added to subpart fax your request to the Division of Pet?,’’ The Christian Science Monitor, August D to read as follows: Compliance (using the same address in 13, 2002, taken from the web on June 12, the previous sentence) at 301–827–1498. 2003, from http://www.csmonitor.com/2002/ § 1240.63 African rodents and other (B) Your request must state the 0813/p03s01–usgn.html. animals that may carry the monkeypox reasons why you need an exemption, 37. Exotic Pets.com, taken from http:// virus. describe the animals involved, describe www.exoticpets.com/ (a) What Actions Are Prohibited? the number of animals involved, ShowlAds.asp?petid=16 on June 12, 2003. What Animals Are Affected? describe how the animals will be 38. Hutin, Y. J. F., et al., ‘‘Outbreak of (1) Except as provided in paragraph transported (including carrying Human Monkeypox, Democratic Republic of (a)(2) of this section, containers or cages, precautions for Congo, 1996–1997,’’ Emerging Infectious Diseases, 7:434–438 (May through June, (i) You must not capture, offer to handlers, types of vehicles used, and 2001). capture, transport, offer to transport, other procedures to minimize exposure sell, barter, or exchange, offer to sell, of animals and precautions to prevent List of Subjects barter, or exchange, distribute, offer to animals from escaping into the 21 CFR Part 16 distribute, or release into the environment), describe any holding environment, any of the following facilities, quarantine procedures, and/or Administrative practice and animals, whether dead or alive: veterinarian evaluation involved in the procedure. (A) Prairie dogs (Cynomys sp.), animals’ movement, and explain why an

VerDate jul<14>2003 14:51 Nov 03, 2003 Jkt 203001 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\FR\FM\04NOR1.SGM 04NOR1 Federal Register / Vol. 68, No. 213 / Tuesday, November 4, 2003 / Rules and Regulations 62369

exemption will not result in the spread (1) Except as provided in paragraphs substantial issue of fact in dispute. We of monkeypox within the United States. (a)(2) and (a)(3) of this section, will issue a written response to the (C) We (FDA) will respond, in writing, (i) You must not import or attempt to appeal, which shall constitute final to all requests, and we also may impose import any rodents, whether dead or agency action. conditions in granting an exemption. alive, that were obtained, directly or (b) What Actions Can FDA Take? indirectly, from Africa, or whose native (3) The prohibitions in paragraph (a) (1) To prevent the monkeypox virus habitat is Africa, any products derived of this section do not apply to products from spreading and becoming from such rodents, any other animal, derived from rodents that were established in the United States, we whether dead or alive, whose obtained, directly or indirectly, from may, in addition to any other authorities importation the Director has prohibited Africa, or whose native habitat is Africa, under this part: by order, or any products derived from or products derived from any other (i) Issue an order causing an animal to such animals; and animal whose importation the Director be placed in quarantine, (ii) You must not prevent or attempt has prohibited by order if such products (ii) Issue an order causing an animal to prevent the Centers for Disease have been properly processed to render to be destroyed, or Control and Prevention (CDC) from them noninfectious so that they pose no (iii) Take any other action necessary causing an animal to be quarantined, re- risk of transmitting or carrying the to prevent the spread of the monkeypox exported, or destroyed under a written monkeypox virus. Such products virus. order. include, but are not limited to, fully (2) Any order to cause an animal to (2) The prohibitions in paragraph taxidermied animals and completely be placed in quarantine or to cause an (a)(1) of this section do not apply if you finished trophies; and they may be animal to be destroyed will be in have written permission from CDC to imported without written permission writing. import a rodent that was obtained, from CDC. (c) How Do I Appeal an Order? directly or indirectly, from Africa, or (1) If you receive a written order to whose native habitat is Africa, or an (b) What Actions Can CDC Take? cause an animal to be placed in animal whose importation the Director (1) To prevent the monkeypox virus quarantine or to cause an animal to be has prohibited by order. from spreading and becoming destroyed, you may appeal that order. (i) To obtain such written permission established in the United States, we Your appeal must be in writing and be from CDC, you must send a written may, in addition to any other authorities submitted to the Food and Drug request to Division of Global Migration under this part: Administration District Director whose and Quarantine, National Center for office issued the order, and you must Infectious Diseases, Centers for Disease (i) Issue an order causing an animal to submit the appeal within two business Control and Prevention, 1600 Clifton be placed in quarantine, days after you receive the order. Rd., Atlanta, GA 30333. You may also (ii) Issue an order causing an animal (2) As part of your appeal, you may fax your request to the Division of to be re-exported, request an informal hearing. Your Global Migration and Quarantine (using (iii) Issue an order causing an animal appeal must include specific facts the same address in the previous showing there is a genuine and sentence) at 404–498–1633. to be destroyed, or substantial issue of fact that requires a (ii) Your request must state the (iv) Take any other action necessary to hearing. reasons why you need an exemption, prevent the spread of the monkeypox (3) If we grant your request for an describe the animals involved, describe virus. informal hearing, we will follow the the number of animals involved, (2) Any order causing an animal to be regulatory hearing requirements at in describe how the animals will be quarantined, re-exported, or destroyed transported (including carrying part 16, except that: will be in writing. (i) The written order will serve as containers or cages, precautions for notice of opportunity for that hearing, handlers, types of vehicles used, and (c) How Do I Appeal an Order? If you for purposes of § 16.22(a) of this other procedures to minimize exposure received a written order to quarantine or chapter; of animals and precautions to prevent re-export an animal or to cause an (ii) The presiding officer will issue a animals from escaping into the animal to be destroyed, you may appeal decision rather than a report and a environment), describe any holding that order. Your appeal must be in recommended decision. The presiding facilities, quarantine procedures, and/or writing and be submitted to the CDC officer’s decision constitutes final veterinarian evaluation involved in the official whose office issued the order, agency action. animals’ movement, and explain why an and you must submit the appeal within 42 CFR CHAPTER I exemption will not result in the spread 2 business days after you receive the of monkeypox within the United States. order. Your appeal must state the PART 71–FOREIGN QUARANTINE Your request must be limited to reasons for the appeal and show that scientific, exhibition, or educational there is a genuine and substantial issue ■ 5. The authority citation for 42 CFR purposes. of fact in dispute. We will issue a part 71 continues to read as follows: (iii) We will respond in writing to all written response to the appeal, which Authority: Secs. 215 and 311 of the Public requests, and we also may impose shall constitute final agency action. Health Service (PHS) Act, as amended (42 conditions in granting an exemption. If U.S.C. 216, 243), secs. 361–369, PHS Act, as we deny your request, you may appeal Dated: October 6, 2003. amended (42 U.S.C. 264–272). that denial. Your appeal must be in Tommy G. Thompson, ■ 6. Section 71.56 is added to subpart F writing and be submitted to the CDC Secretary of Health and Human Services. read as follows: official whose office denied your [FR Doc. 03–27557 Filed 11–3–03; 8:45 am] request, and you must submit the appeal BILLING CODE 4160–01–S § 71.56 African rodents and other animals within two business days after you that may carry the monkeypox virus. receive the denial. Your appeal must (a) What Actions Are Prohibited? state the reasons for the appeal and What Animals Are Affected? show that there is a genuine and

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