[Federal Register Volume 68, Number 213 (Tuesday, November 4, 2003)]
[Rules and Regulations]
[Pages 62353-62369]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 03-27557]



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Rules and Regulations
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Federal Register / Vol. 68, No. 213 / Tuesday, November 4, 2003 / 
Rules and Regulations

[[Page 62353]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 1240

[Docket No. 2003N-0400]
RIN 0910-ZA21

Centers for Disease Control and Prevention

42 CFR Part 71


Control of Communicable Diseases; Restrictions on African 
Rodents, Prairie Dogs, and Certain Other Animals

AGENCIES: Centers for Disease Control and Prevention, Food and Drug 
Administration (HHS).

ACTION: Interim final rule; opportunity for public comment.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC) and the 
Food and Drug Administration (FDA) are issuing this interim final rule 
to amend their regulations to establish new restrictions and modify 
existing restrictions on the import, capture, transport, sale, barter, 
exchange, distribution, and release of African rodents, prairie dogs, 
and certain other animals. We are taking this action to prevent the 
spread of monkeypox, a communicable disease, in the United States.

DATES: The interim final rule is effective on November 4, 2003. Submit 
written or electronic comments on this interim final rule by January 
20, 2004.

ADDRESSES: For FDA: Send written comments on the rule and on the 
information collection to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to http://www.fda.gov/dockets/
ecomments.
    For CDC: Send written comments on the information collection to 
Anne O'Connor, CDC Assistant Reports Clearance Officer, 1600 Clifton 
Rd., MS E11, Atlanta, GA 30333. Comments on the rule itself should be 
sent to FDA's Division of Dockets Management (see FDA addresses).

FOR FURTHER INFORMATION CONTACT: 
    For information regarding FDA: Philip L. Chao, Office of Policy and 
Planning (HF-23), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-0587.
    For information regarding CDC: James E. Barrow, National Center for 
Infectious Diseases, Centers for Disease Control and Prevention, 
Mailstop C-14, 1600 Clifton Rd., Atlanta, GA 30333, 404-498-1600.

SUPPLEMENTARY INFORMATION:

I. What Is Monkeypox, and How Did It Spread in the United States?

    Monkeypox is a rare, zoonotic, viral disease that occurs primarily 
in the rain forest countries in central and west Africa. (A zoonotic 
disease is a disease of animals that can be transmitted to humans under 
natural conditions.) The illness was first noted in monkeys in 1958 
(which explains its name), but, in Africa, serologic evidence of 
monkeypox infection has been found in many other species, including 
some species of primates, rodents, and lagomorphs (which includes such 
animals as rabbits). African rodents are considered to be the most 
likely natural host of the monkeypox virus (Ref. 1).
    In humans, monkeypox is marked by rashes that are similar to those 
seen in smallpox; other signs and symptoms include a temperature at or 
above 99.3 degrees, chills and/or sweats, headache, backache, 
lymphadenopathy (a disease of the lymph nodes), sore throat, cough, and 
shortness of breath (Ref. 2). The disease's incubation period is 
approximately 12 days (Ref. 3). In Africa, monkeypox has a mortality 
rate in humans ranging from 1 to 10 percent.
    As of July 8, 2003, there have been 35 laboratory-confirmed cases 
of monkeypox in people in the United States, and about another three 
dozen suspect and probable cases under investigation, in Illinois, 
Indiana, Kansas, Ohio, Missouri, and Wisconsin (Ref. 4). As of July 11, 
2003, 16 persons were reported to have been hospitalized; however, some 
of these hospitalizations were for isolation purposes unrelated to 
illness. Among those hospitalized, two were children who required 
intensive care, one for severe monkeypox-associated encephalitis 
(encephalitis is an inflammation of the brain), and one with profound 
painful cervical and tonsillar adenopathy (adenopathy refers to an 
enlargement of the glands) and diffuse pox lesions, including lesions 
in the oropharynx. Both children recovered from their illness.
    In the United States, individuals apparently began contracting 
monkeypox in early May, 2003, primarily as a result of contact with 
prairie dogs that had contracted monkeypox from diseased African 
rodents. Investigations indicate that a Texas animal distributor 
imported a shipment of approximately 800 small mammals from Ghana on 
April 9, 2003, and that shipment contained 762 African rodents, 
including rope squirrels (Funiscuirus sp.), tree squirrels 
(Heliosciurus sp.), Gambian giant pouched rats (Cricetomys sp.), 
brushtail porcupines (Atherurus sp.), dormice (Graphiurus sp.), and 
striped mice (Hybomys sp.). Some animals were infected with monkeypox, 
and CDC laboratory testing confirmed the presence of monkeypox in 
several rodent species, including one Gambian giant pouched rat, three 
dormice, and two rope squirrels (Ref. 4). Of the 762 rodents from the 
original shipment, 584 have been traced to distributors in six states. 
A total of 178 African rodents could not be traced beyond the point of 
entry in Texas because records were not available (Ref. 4). The number 
of animals traced may change as the investigation continues.

II. What Actions Have Been Taken to Prevent the Spread of Monkeypox?

    Non-native animal species, such as the African rodents, can create 
serious public health problems when they introduce a new disease, such 
as monkeypox, to the native animal and human populations. The 
transportation, sale, or distribution of an infected animal, or the 
release of an infected animal into the environment can result in the 
further spread of disease to other animal species and to humans.
    Several States have issued orders or emergency rules to prohibit 
the

[[Page 62354]]

importation, sale, distribution, release, disposal, and/or display of 
prairie dogs and certain rodents (Refs. 5 through 11). However, these 
State efforts are limited to their respective jurisdictions, and some 
State orders or rules expire on a specific date, while others differ in 
the types of animals and actions that are covered. Communicable 
diseases, such as monkeypox, are not confined by State borders and, as 
shown by the presence of the monkeypox virus in prairie dogs, may 
affect multiple animal species. Consequently, Federal action was 
necessary to help prevent the spread of monkeypox. On June 11, 2003, 
the Director of CDC and the Commissioner of Food and Drugs, under 42 
CFR 70.2 and 21 CFR 1240.30 respectively, issued a joint order (Ref. 
12) prohibiting, until further notice, the transportation or offering 
for transportation in interstate commerce, or the sale, offering for 
sale, or offering for any other type of commercial or public 
distribution, including release into the environment, of:
    [sbull] Prairie dogs (Cynomys sp.);
    [sbull] Tree squirrels (Heliosciurus sp.);
    [sbull] Rope squirrels (Funisciurus sp.);
    [sbull] Dormice (Graphiurus sp.);
    [sbull] Gambian giant pouched rats (Cricetomys sp.);
    [sbull] Brush-tailed porcupines (Atherurus sp.), and
    [sbull] Striped mice (Hybomys sp.).
    The June 11, 2003, order did not apply to the transport of these 
animals to veterinarians or animal control officials or other entities 
under guidance or instructions issued by Federal, State, or local 
government authorities. In addition, under 42 CFR 71.32(b), CDC 
implemented an immediate embargo on the importation of all rodents from 
Africa (order Rodentia).
    Both CDC and FDA are also working closely with other Federal 
agencies, such as the Animal and Plant Health Inspection Service 
(APHIS) in the Department of Agriculture (USDA), the Fish and Wildlife 
Service (FWS) in the Department of the Interior, Customs and Border 
Protection in Department of Homeland Security, and the Department of 
Transportation. FDA and CDC are also working with numerous State and 
local agencies to prevent further exposure of animals and people to the 
monkeypox virus.

III. What Does The Interim Final Rule Do?

A. Why Are FDA and CDC Issuing an Interim Final Rule?

    We issued the June 11, 2003, order to address quickly what was then 
a new and rapidly developing monkeypox outbreak (Ref. 13). We now are 
able to provide a more detailed set of measures aimed at creating a 
regulatory approach to prevent the monkeypox virus from becoming 
established and spreading in the United States, with exemption 
procedures to accommodate special circumstances, and are doing so by 
issuing this interim final rule. This interim final rule supersedes the 
June 11, 2003, order. As appropriate, we will amend the interim final 
rule in response to comments and to any new developments in the 
monkeypox outbreak.
    This interim final rule creates two complementary regulations. 
First, with respect to certain animals that are in the United States, 
the interim final rule adds 21 CFR 1240.63, entitled ``African rodents 
and other animals that may carry the monkeypox virus.'' FDA will 
enforce 21 CFR 1240.63. Second, for African rodents that are being 
imported or offered for import to the United States, the interim final 
rule adds 42 CFR 71.56, that is also entitled ``African rodents and 
other animals that may carry the monkeypox virus.'' CDC will enforce 42 
CFR 71.56. Together, 21 CFR 1240.63 and 42 CFR 71.56 are intended to 
prevent the establishment and spread of the monkeypox virus in the 
United States.
    Section 361 of the Public Health Service Act (PHS act) (42 U.S.C. 
264) serves as the legal authority for both 21 CFR 1240.63 and 42 CFR 
71.56. Section 361 of the PHS act gives the Secretary of Health and 
Human Services the authority to make and enforce regulations to prevent 
the introduction, transmission, and spread of communicable diseases 
from foreign countries into the States or from one State to another 
State. As we explain in section IV of this document, both FDA and CDC 
have issued regulations under section 361 of the PHS act, and several 
FDA regulations are similar or identical to CDC regulations. Here, 
however, the responsibilities are being divided between our two 
agencies. FDA's regulation focuses on animals moving between and within 
States while CDC's regulation focuses on imported animals. Our goal in 
creating separate FDA and CDC regulations is to use our limited 
resources to deal with the current monkeypox situation in the most 
efficient manner possible.

B. What Does FDA's Rule Say?

1. Where Is the Rule Codified? (21 CFR 1240.63)
    As we stated in section III.A of this document, the interim final 
rule adds 21 CFR 1240.63, entitled ``African rodents and other animals 
that may carry the monkeypox virus.''
2. What Does the Rule Prohibit? (21 CFR 1240.63(a))
    21 CFR 1240.63(a)(1) contains several general prohibitions. In 
brief, under 21 CFR 1240.63(a)(1)(i), regardless of your status (such 
as a pet dealer, pet owner, researcher, animal trapper, zoological park 
administrator, etc.), you must not capture, offer to capture, 
transport, offer to transport, sell, barter, or exchange, offer to 
sell, barter, or exchange, distribute, offer to distribute, or release 
into the environment:
    [sbull] Prairie dogs (Cynomys sp.),
    [sbull] African Tree squirrels (Heliosciurus sp.),
    [sbull] Rope squirrels (Funisciurus sp.),
    [sbull] African Dormice (Graphiurus sp.),
    [sbull] Gambian giant pouched rats (Cricetomys sp.),
    [sbull] Brush-tailed porcupines (Atherurus sp.),
    [sbull] Striped mice (Hybomys sp.), or
    [sbull] Any other animal so prohibited by order of the Commissioner 
of Food and Drugs because of that animal's potential to transmit the 
monkeypox virus.
    For convenience, this preamble will refer to the above animals as 
``listed animals.''
    The interim final rule covers the listed animals because animals 
from those species have been associated, either directly through 
laboratory tests or indirectly through epidemiological evidence, in the 
current outbreak of the monkeypox virus in humans (Ref. 14). In 
general, the animals identified in 21 CFR 1240.63 are the same as those 
listed in the CDC-FDA order dated June 11, 2003, except that the rule 
also refers to other, yet-unspecified kinds of animals that the 
Commissioner of Food and Drugs may prohibit by order. FDA included the 
latter ``catch-all'' provision in Sec.  1240.63 because the agency 
cannot preclude the possibility that monkeypox may spread to other 
animal species, and, if monkeypox is found in other animals, FDA needs 
to be able to list those animals quickly. FDA derives its authority to 
list such animals by order from section 361 of the Public Health 
Service Act, which is the same statutory authority under which it is 
issuing this interim final rule. This statutory provision authorizes 
the Secretary to make and enforce regulations to prevent the 
introduction, transmission, and spread of communicable diseases. 
Section 1240.63(b)(1) of the interim final rule (which we discuss later 
in this section) allows FDA to issue orders causing such animals to be 
quarantined or destroyed and to ``take any other action necessary to 
prevent the spread

[[Page 62355]]

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

[[Page 62356]]

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

[[Page 62357]]

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

C. What Does CDC's Rule Say?

1. Where Is the Rule Codified? (42 CFR 71.56)
    The interim final rule creates a new 42 CFR 71.56 titled, ``African 
rodents and other animals that may carry the monkeypox virus.''
2. What Does the Rule Prohibit? (42 CFR 71.56(a))
    42 CFR 71.56(a) contains only two general prohibitions. In brief, 
under 42 CFR 71.56(a)(1)(i), you must not import or offer to import any 
rodents, whether dead or alive, that were obtained, directly or 
indirectly, from Africa, or whose native habitat is Africa; any 
products derived from such rodents, any other animal, whether dead or 
alive, whose importation the Director of CDC has prohibited by order, 
or any products derived from such animals. This provision is intended 
to prevent the further importation of infected and potentially-infected 
rodents and represents a slight modification from the import 
restriction that appeared in the June 11, 2003, order. The June 11, 
2003, order barred importation of ``all rodents from Africa.'' The 
rule's import prohibition is intended to make clear that it covers any 
rodents that were caught in Africa and then shipped directly to the 
United States or shipped to other countries before being imported to 
the United States. The prohibition also applies to rodents whose native 
habitat is in Africa, even if those rodents

[[Page 62358]]

were born elsewhere. For example, 42 CFR 71.56(a)(1)(i) would apply to 
a Gambian giant pouched rat even if that animal was born outside 
Africa. A broad import ban on African rodents is necessary because 
there is no quick, practical method for determining whether a specific 
animal was born in a particular geographic region. The import 
restriction complements efforts taken by the U.S. Fish and Wildlife 
Service to prevent the importation of infected animals (Ref. 20).
    Similarly to 21 CFR 1240.63, 42 CFR 71.56 applies to dead animals. 
Some individuals have attempted to conceal ``bushmeat'' (a term used to 
describe meat obtained from animals taken in the wild or the ``bush'') 
from Federal authorities since the June 11, 2003, order was issued and 
others have attempted to import preserved specimens of listed species. 
The monkeypox virus can remain infectious in bushmeat (Refs. 1, 21, and 
38), and CDC is unaware of data demonstrating the safety of raw or even 
prepared bushmeat. Preparation methods such as smoking, salting, or 
brining bushmeat may slow down bushmeat's decay, but may not render 
bushmeat free of infectious agents. Therefore, 42 CFR 71.56(a)(1) 
applies to live and dead African rodents.
    42 CFR 71.56(a)(1)(ii) states that you must not prevent or attempt 
to prevent CDC from causing an animal to be quarantined, re-exported, 
or destroyed pursuant to a written order for that animal's quarantine, 
re-export, or destruction. (For purposes of this rule, ``quarantine'' 
means that the animal is held or stored in an isolated area, and all 
further movement has been restricted so as not to expose other 
animals.) Most individuals will cooperate with a written order to 
quarantine, re-export, or destroy an infected animal, but some 
individuals may attempt to avoid those consequences by releasing the 
animal instead. Releasing an infected or potentially infected animal 
would create a serious risk to animal and human health because the 
monkeypox virus could then spread to native animal species and become 
established in the United States. Therefore, if you prevent or attempt 
to prevent us from causing an animal to be quarantined, re-exported, or 
destroyed, you may be subject to criminal penalties. (For more 
information on penalties, section IV of this document.)
    Similarly to 21 CFR 1240.63(a)(2), 42 CFR 71.56(a)(2) recognizes 
that there are limited circumstances warranting exemptions from some 
prohibitions. Consequently, under 42 CFR 71.56(a)(2), an individual may 
seek written permission from CDC to import any rodents that were 
obtained, directly or indirectly, from Africa, or whose native habitat 
is Africa, or any other kind of animal whose importation the Director 
has prohibited by order. The interim final rule describes the 
procedures for seeking written permission from CDC and the information 
that should be submitted with any request and also states that the 
request must be limited to scientific, exhibition (such as exhibition 
of an animal at a zoo), or educational purposes. CDC is limiting the 
request to scientific, exhibition, or educational purposes because it 
recognizes the important contributions that these rodents may make to 
science, education, and conservation. CDC will respond, in writing, to 
all requests, and it also may impose conditions in granting an 
exemption. If CDC decides against granting written permission, that 
decision may be appealed by writing to the CDC official whose office 
denied the request. The appeal must state the reasons for the appeal 
and show there is a genuine and substantial issue of fact in dispute. 
CDC will issue a written response to the appeal which will constitute 
final agency action.
    42 CFR 71.56(a)(3) represents another exemption from the import 
restrictions. Some individuals have asked whether they could import 
taxidermied animals or animal trophies, while other questions have 
involved products derived from animals, such as brushes that use animal 
hair and animal skins. Products derived from rodents, such as products 
that use rodent hair, quills, bones, and skins, may contain viable 
monkeypox virus if the animal from which they are derived was infected 
with monkeypox. This is based on the fact that variola virus, a related 
pox virus, has been shown to remain viable in proteinaceous exudates 
for as long as 1 year (Ref. 22). If these products are properly 
processed to render them noninfectious, they pose no disease risk. Such 
processes would include inactivation by:
    [sbull] Heat (heated to an internal temperature of 70 [deg]C or 
placed in boiling water for a
    minimum of 30 minutes);
    [sbull] Preservation in 2 percent formaldehyde;
    [sbull] Chemically treating in acidic or alkaline solutions 
(soaking in a solution below pH 3.0 or above pH 11.5 for 24 hours); or
    [sbull] The use of hypertonic salts.
Vaccinia virus, a related pox virus, was shown to be inactivated after 
heating in neutral salt buffer solution for 90 minutes at 50 [deg]C or 
after heating for 60 minutes at 55 [deg]C (Ref. 23). Support for these 
methods can be found in the pox virus material safety data sheet 
compiled by Health Canada, http://www.hc-sc.gc.ca/pphb-dgspsp/msds-
ftss/msds160e.html, which states that pox viruses are rendered 
nonviable by 2 percent formaldehyde, and heating to 60 
[deg]C. Procedures for alkaline and acid inactivation are based on the 
OIE 2003 Terrestrial Animal Code procedures for food and mouth disease 
(Article 3.6.2.1) (http://www.oie.int/eng/normes/MCode/A--00144.htm). 
(FDA has verified the Web site address, but FDA is not responsible for 
any subsequent changes to the Web site after this document publishes in 
the Federal Register.) Products derived from African rodents, if 
treated using one of these methods, are not subject to the import 
prohibition at 42 CFR 71.56(a)(1) and may be imported without written 
permission from CDC. Similarly, fully taxidermied African rodents and 
completely finished trophies present no disease risk and therefore may 
be imported without written permission from CDC. Products imported 
under the exception in 42 CFR 71.56(a)(3) are subject to inspection to 
ensure that they do meet the conditions set forth in 42 CFR 
71.56(a)(3).
3. What Actions Can CDC Take? (42 CFR 71.56(b))
    To prevent the monkeypox virus from spreading and becoming 
established in the United States, 42 CFR 71.56(b) gives CDC the 
authority to:
    [sbull] Issue an order causing an animal to be placed in 
quarantine;
    [sbull] Issue an order causing an animal to be re-exported;
    [sbull] Issue an order causing an animal to be destroyed; or
    [sbull] Take any other action necessary to prevent the spread of 
the monkeypox virus.
    The Director of CDC can also use other authorities to help prevent 
the spread of monkeypox. For example, under 42 CFR 71.32(b), if the 
Director has reason to believe that there is an article (including an 
animal) arriving at a United States port and that article is or may be 
infected with a communicable disease, the Director may require such 
actions as detention, disinfection, or other related measures necessary 
to prevent the introduction, transmission, or spread of communicable 
disease. Consequently, 42 CFR 71.56(b) recognizes that the Director may 
use other authorities, and states that the authority to issue orders or 
to take other action is ``in addition to any other authorities under 
this part.''
    Any orders issued by CDC, similar to those issued by FDA, will be 
in writing and will contain other details, such as

[[Page 62359]]

the animals covered by the order, the ability to appeal an order, and 
any other conditions on quarantine, re-export, or destruction. CDC 
officials ordinarily will not themselves quarantine, re-export, or 
destroy an animal. Instead, CDC officials will order that the animal be 
quarantined, re-exported, or destroyed, and the individual receiving 
the order will be reponsible for placing the animal in quarantine or 
having it re-exported or destroyed and be responsible for any costs 
associated with quarantining, re-exporting, or destroying the animal. 
CDC has issued guidance to animal health officials on the disposition 
of animals.
    CDC emphasizes that there may be instances where it is difficult to 
identify an animal as belonging to a particular species. Some species 
may resemble another, and juvenile animals may look different from 
adult animals. Thus, if you import any rodent, CDC strongly advises you 
to take steps to accurately and reliably identify the species involved. 
Accurate and reliable identification will reduce the potential for 
disagreements as to whether an animal is or should be subject to an 
order and avoid potential, unfortunate instances where animals that 
cannot be readily identified or whose species identification is in 
dispute are included in an order to cause their destruction.
4. Can You Appeal an Order? (42 CFR 71.56(c))
    If you received a written order to cause an animal to be placed in 
quarantine, re-exported, or destroyed, 42 CFR 71.56(c) explains that 
you may appeal that order. Your appeal must be in writing and be 
submitted to the CDC official whose office issued the order, and you 
must submit the appeal within 2 business days after you receive the 
order. Your appeal must state the reasons for the appeal and show that 
there is a genuine and substantial issue of fact in dispute. CDC will 
issue a written response to the appeal which will constitute final 
agency action.

D. When Does the Rule Become Effective?

    For the effective date of the interim final rule see the DATES 
section of this document.

E. Will We Revoke Or Amend the Rule if Monkeypox Is Eradicated in the 
United States?

    Monkeypox is endemic in parts of Africa. Therefore, we do not 
anticipate revoking the prohibition on import of African rodents and 
any other animals that the Director of CDC has specified under 42 CFR 
71.56(a)(1)(i). However, FDA will revoke or amend, as warranted, all or 
parts of 21 CFR 1240.63 if FDA concludes that monkeypox is eradicated 
or adequately controlled so that the virus does not become established 
in the United States. FDA's decision would depend on scientific 
principles for controlling zoonotic diseases. For example, if the 
incubation period is known, then it would be prudent to continue the 
restrictions for a time period that is double the incubation period to 
ensure that there is little further risk of infection or restarting the 
monkeypox outbreak. CDC tests on some animals involved in the original 
April 9, 2003, shipment from Ghana suggest that, insofar as dormice are 
concerned, the incubation period may be as long as 2.5 months. If FDA 
rounds this time frame up to 3 months, and then doubles the incubation 
period, there would appear to be little further risk of infection after 
6 months had passed with no further evidence of monkeypox identified, 
and FDA would be able to take actions to revoke or amend 21 CFR 
1240.63. The last infected animal from the April 9, 2003, shipment that 
died from monkeypox died on July 20, 2003. There have been no 
identified monkeypox cases in animals or people in the United States 
since that date. If no further monkeypox cases are identified in the 
United States, and if there is no new information warranting an 
extension of the 6-month time period, FDA intends to revoke or amend 21 
CFR 1240.63 as early as January 20, 2004, which will be 6 months after 
July 20, 2003. At that time, if FDA decided to revoke or amend 21 CFR 
1240.63, it would publish an appropriate document (such as a proposed 
rule or direct final rule) in the Federal Register. FDA invites 
comments on this approach.
    We emphasize that any possible revocation or amendment of 21 CFR 
1240.63 may also depend on new data or new developments. For example, 
various animal studies are being conducted to learn more about the 
incubation period and transmission dynamics of monkeypox. If those 
studies suggest that the period for incubation and transmission may be 
longer than 2.5 months, FDA could decide to recalculate the date on 
which it might revoke or amend 21 CFR 1240.63. Studies are also 
underway to determine whether certain species that may be infected with 
the virus, but not display any symptoms, can infect other species. To 
illustrate how the virus could spread from an asymptomatic animal, 
assume that an animal can carry the monkeypox virus, but that the 
animal does not develop monkeypox. If that animal later comes into 
contact with prairie dogs, a species which is already known to be 
susceptible to monkeypox, then the prairie dogs could become infected, 
and another monkeypox outbreak in prairie dogs could erupt. Again, if 
studies suggest that species can be asymptomatic, but still infectious, 
those results could cause FDA to recalculate the date on which it could 
revoke or amend 21 CFR 1240.6.

F. What Actions Can be Taken to Prevent Outbreaks of Other Zoonotic 
Diseases?

    If another outbreak of a different zoonotic disease occurred in the 
United States, we would take actions comparable to those we have taken 
to address monkeypox, modifying those actions as appropriate to the new 
circumstances. However, we believe that the introduction of monkeypox 
into the United States shows that we need to develop measures to 
prevent or minimize the likelihood of other zoonotic disease 
introductions or outbreaks. As noted in section IV of this document, 
section 361 of the PHS Act authorizes the Secretary to make and enforce 
such regulations as judged necessary to prevent the introduction, 
transmission, or spread of communicable diseases from foreign countries 
into the States or from one State to another State. We may regulate 
intrastate transactions under this authority as appropriate (see State 
of Louisiana v. Mathews, 427 F. Supp. 174 (E.D. La. 1977)). We may, 
therefore, publish a document in the Federal Register that would 
discuss possible regulatory approaches, such as:
    [sbull] Banning the import into the United States, as well as the 
capture, sale and distribution within the United States, of certain 
categories of: Animals (e.g., rodents, marsupials, and bats), or 
animals captured in the wild, or animals captured in the wild from 
certain regions of the world, including regions within the United 
States (e.g., prairie dogs in the United States due to their potential 
to carry plague or tularemia); or
    [sbull] Requiring health certifications and subsequent quarantine 
and health examination and/or testing prior to import or domestic 
distribution of certain categories of animals; or
    [sbull] Requiring assessments of potential disease risks prior to 
import or domestic distribution of certain categories of animals, with 
the imposition of conditions or restrictions depending on the level of 
risk presented.
If we decide to publish a document in the Federal Register that 
addresses the

[[Page 62360]]

broader issues of zoonotic diseases and exotic species, that document 
will provide an opportunity for public comment on those issues.

IV. What Is the Legal Authority for This Rulemaking?

    Because the public health objective is to prevent the spread of 
communicable disease, we are issuing the rule under section 361 of the 
Public Health Service Act (PHS act) (42 U.S.C. 264). Section 361 of the 
PHS act authorizes the Secretary to make and enforce such regulations 
as judged necessary to prevent the introduction, transmission, or 
spread of communicable diseases from foreign countries into the States 
or from one State to another State. We may regulate intrastate 
transactions under this authority as appropriate (see State of 
Louisiana v. Mathews, 427 F. Supp. 174 (E.D. La. 1977)).
    Section 361 of the PHS act also provides for such inspection and 
destruction of articles found to be so infected or contaminated as to 
be sources of dangerous infection to humans, and other measures, as may 
be deemed by the Secretary to be necessary.
    We have invoked section 361 of the PHS act to regulate various 
activities and articles. FDA has invoked this authority, for example, 
to prevent the transmission of communicable disease through certain 
shellfish, turtles, certain birds, and human tissue intended for 
transplantation (see 21 CFR 1240.60 (molluscan shellfish), 1240.62 
(turtles), 1240.65 (psittacine birds), and 1270.1 through 1270.43 
(human tissue)). CDC has invoked section 361 of the PHS act to control 
the importation of dogs and cats, turtles, nonhuman primates, 
etiological agents, and dead bodies (see 42 CFR 71.51 through 71.55, 
respectively). CDC has also regulated the interstate shipment of 
etiologic agents under this authority (see 42 CFR part 72).
    Section 368 of the PHS act (42 U.S.C. 271) provides the authority 
to enforce section 361 of the PHS act. Under section 368(a) of the PHS 
act, any person who violates a regulation prescribed under section 361 
of the PHS act may be punished by imprisonment for up to 1 year (42 
U.S.C. 271(a)). Individuals may also be punished for violating such a 
regulation by a fine of up to $100,000 per violation if death has not 
resulted from the violation or up to $250,000 per violation if death 
has resulted (18 U.S.C. 3559, 3571(b)). Organizations may be fined up 
to $200,000 per violation not resulting in death and $500,000 per 
violation resulting in death (18 U.S.C. 3559, 3571(c)). In addition, 
Federal district courts have jurisdiction to enjoin individuals and 
organizations from violating regulations implementing section 361 of 
the PHS Act. You should also note that if we add more animals under 21 
CFR 1240.63(a)(1)(i)(H) or 42 CFR 71.56(a)(1)(i), any violation 
involving those additional animals would be considered to be a 
violation of a regulation prescribed under section 361 of the PHS act.
    We are proceeding without notice and comment rulemaking because we 
need to have regulations in place immediately to address the monkeypox 
situation. Under the provisions of the Administrative Procedure Act at 
5 U.S.C. 553(b)(B), we find for good cause that prior notice and 
comment on this rule are impracticable and contrary to the public 
interest. It is imperative that we act quickly to clarify and maintain 
restrictions on the African rodents, prairie dogs, and other animals to 
prevent the monkeypox virus from spreading and becoming established in 
the United States.

V. What Is the Environmental Impact?

    FDA has determined under 21 CFR 25.32(g) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.
    In the absence of an applicable categorical exclusion, the 
Director, CDC, has determined that provisions amending 42 CFR part 70 
will not have a significant impact on the human environment. This 
determination is consistent with the FDA determination that the 
provisions in 21 CFR part 1240 are covered by a categorical exclusion.

VI. What Is the Result of the Analysis of Impacts?

    We have examined the impacts of the interim final rule under 
Executive Order 12866, and the Regulatory Flexibility Act (5 U.S.C. 
601-612), and under the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 
1501 et seq.). Executive Order 12866 directs agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages, distributive impacts, and 
equity). Unless we certify that the rule is not expected to have a 
significant economic impact on a substantial number of small entities, 
the Regulatory Flexibility Act, as amended by the Small Business 
Regulatory Flexibility Act (SBREFA), requires agencies to analyze 
regulatory options that would minimize any significant economic impact 
of a rule on small entities. Section 202 of UMRA requires that agencies 
prepare a written statement of anticipated costs and benefits before 
proposing any rule that may result in an expenditure by State, local, 
and tribal governments in the aggregate, or by the private sector, of 
$100 million in any one year (adjusted annually for inflation). We have 
conducted analyses of the rule, and have determined that the rule is 
consistent with the principles set forth in the Executive Order and in 
these statutes.
    The interim final rule is not a significant regulatory action as 
defined by the Executive Order. This regulatory action is also not a 
major rule under the Congressional Review Act. However, the Regulatory 
Flexibility Analysis concludes that the rule may have a significant 
impact on a substantial number of small entities. The Unfunded Mandates 
Reform Act does not require us to prepare a statement of costs and 
benefits for the interim final rule because the rule is not expected to 
result in any one-year expenditure that would exceed $100 million 
adjusted for inflation. The current inflation-adjusted statutory 
threshold is about $110 million.

A. Objectives and Basis for the Action

    Incomplete data preclude us from developing a quantitative estimate 
of the economic benefits or costs of this rule. However, we believe 
that the rule is necessary to minimize the risk of establishing and 
spreading the monkeypox virus. The rule formalizes an administrative 
ban on trade, transport, and import of certain animals and sets forth a 
process to obtain exemptions. In particular, the interim final rule 
prohibits the capture, offer to capture, transport, offer to transport, 
sale, barter, or exchange, offer to sell, barter, or exchange, 
distribution, offer to distribute, and release into the environment of 
prairie dogs and other specific animals, and it prohibits importation 
of African rodents. The interim final rule supersedes the June 11, 
2003, order and allows permits for exemptions in cases that pose little 
risk of establishing or spreading the monkeypox virus.

B. The Nature of the Impacts

    This rule has several impacts. It continues and clarifies the 
prohibition of the import of African rodents, as well as the capture, 
offer to capture,

[[Page 62361]]

transport, offer to transport, sale, barter, or exchange, offer to 
sell, barter, or exchange, distribution, offer to distribute, and 
release into the environment of prairie dogs and other specific 
animals, but allows parties to apply for exemptions in instances that 
would not pose a risk of establishing or spreading the monkeypox virus. 
Thus, importers of small mammals would have to find animals other than 
African rodents to satisfy market demands for unusual pets. Firms that 
supply prairie dogs and other listed animals as pets would be unable to 
do so and would have to switch to different animals. In addition, some 
animals may be destroyed if it is determined that such action is 
necessary to prevent the further spread of monkeypox in the United 
States. While we have not generated quantitative estimates of the 
magnitude of these effects, available evidence suggests that they are 
relatively small.
    We invite comment on the economic analysis in support of this 
interim final rule.

C. Need for the Rule

    A new infectious disease, if uncontrolled, can have large adverse 
economic effects. It does so because a single infection can lead to a 
few new cases, which in turn can lead to many others. Through this 
multiplier effect, a single uncontrolled case of a new disease may 
trigger an epidemic. For example, West Nile virus, a mosquito-borne 
zoonotic disease originally from Africa, sickened more than four 
thousand Americans and killed 284 in 2002 alone, although it was not 
recorded in the United States before 1999 (Ref. 24). West Nile virus 
has also affected populations of many indigenous species of birds and 
mammals. Existing economic incentives to control such risks are 
generally inadequate because the costs of such risks to third parties 
are not borne by the owners of infected animals.
    Notwithstanding the inadequacy of incentives to control risks 
associated with monkeypox virus, trade in some of the animal species 
affected by this rule fell before any announced government action. An 
on-line trading service, exoticpets.com, listed on June 13, 2003, all 
of the advertisements to sell prairie dogs that had been posted since 
May 15, 2003. These data, though they represent advertised prices and 
not the actual prices of completed transactions at a single website, 
suggest that the market responded very quickly to rumors linking 
prairie dogs to the monkeypox outbreak. Five announcements to sell or 
to buy prairie dogs as pets appeared in the 7 days beginning May 15, 
2003. Three more advertisements appeared in the 7 days starting May 22, 
2003, and ending May 28, 2003, with the very last announcement posted 
on May 27, 2003.
BILLING CODE 4160-01-S

[[Page 62362]]

[GRAPHIC] [TIFF OMITTED] TR04NO03.002

BILLING CODE 4160-01-C

[[Page 62363]]

    The prairie dog trading market then seemed to vanish, even before 
the earliest report linking prairie dogs to the outbreak of monkeypox. 
On June 6, 2003, one day before any announcement by CDC, Wisconsin 
health officials banned the sale, importation, and display of prairie 
dogs because of human disease outbreak associated with animal-borne 
transmission (Ref. 25). Three notices mentioning the illness and the 
restrictions on trade appear at exoticpets.com in lieu of 
advertisements on June 8 and 9, 2003. No subsequent announcements or 
advertisements appear on the website. These data, summarized in Figure 
1, suggest that the market reactions to risks of contaminated pets may 
have already curtailed most, if not all, of the retail trade.\1\ 
Statistical testing of the prairie dog advertisement appearance rates 
before and after the CDC announcement shows a 99.3 percent chance that 
there was a real change in the daily advertisement appearance rate 
(i.e., the rate difference is very likely not the result of mere 
chance).\2\ According to the prices listed in classified advertisements 
posted at exoticpets.com, neither the markets for other pets, such as 
rabbits, nor the frequency of such advertisements, have been affected.
---------------------------------------------------------------------------

    \1\ Figure 1 excludes one advertisement because it was a 
solicitation to buy without reference to price.
    \2\ From May 15, 2003, through May 28, 2003 (14 days inclusive), 
there were 8 days when advertisements for prairie dogs appeared at 
the web site for exoticpets.com. Thus, on about 57 percent (8/
14=0.571) of the days, prairie dog advertisements appeared. From May 
29, 2003 through June 6, 2003 (9 days inclusive), there were no 
(zero) days when prairie dog advertisements appeared. According to 
Fisher's Exact Test, the probability that these two statistics came 
from the same distribution is 0.0072. In other words, we are 99.3 
percent certain that there was a change in the daily appearance of 
prairie dog advertisements between these two time periods.
---------------------------------------------------------------------------

    While the market has responded quickly to the outbreak, it is also 
important to note that the market enabled the outbreak to occur in the 
first place. With less vigilant public health surveillance, or with 
private parties that were less cooperative or less responsible, 
infected prairie dogs could have been distributed more broadly in 
commerce, posing greater disease risks. In addition, infected prairie 
dogs might have been released into the wild, posing large risks to 
native mammals and, through them, to humans. This rule would minimize 
the risks that such events could occur by requiring permits if 
individuals capture, transport, sell, barter, exchange, distribute, or 
release animals that have been implicated in the monkeypox outbreak.

D. Baseline

    Economic analysis of a regulatory action requires as a first step 
the identification of a baseline, a depiction of the world in the 
absence of any action, from which to calculate the effects of the 
regulations. The baseline for this rule is complicated by at least two 
issues. First, as noted, news of the epidemic has curtailed trade in 
advance of Federal action. Buyers and sellers do not want to trade 
animals that may be infected with a virus that can make people sick. To 
distinguish between the effects of our actions to ban trade in certain 
animals and the effects of monkeypox on such trade, this analysis uses 
as a baseline the current state of affairs; that is, it recognizes that 
the outbreak is ongoing and that the market has responded.
    An administrative order issued by FDA and CDC on June 11, 2003, and 
intended to manage the same risks as this interim final rule also 
complicates efforts to identify a baseline. We propose to use two 
baselines to provide full information about the effects of our actions. 
First, we assume that there is no administrative order, and second, we 
assume that the baseline includes the June 11, 2003, order.
    With the second baseline there are no costs and no benefits because 
the interim rule formalizes and clarifies the June 11, 2003, order, 
with the important exception of a new procedure for Federal permits 
allowing people to import, capture, offer to capture, transport, offer 
to transport, sell, barter, or exchange, offer to sell, barter, or 
exchange, distribute, offer to distribute, and release into the 
environment prairie dogs and other specific animals when it otherwise 
would be prohibited. Relative to the outright prohibition in the June 
11, 2003, order, permits would lower costs to parties seeking to 
import, capture, offer to capture, transport, offer to transport, sell, 
barter, or exchange, offer to sell, barter, or exchange, distribute, 
offer to distribute, and release into the environment listed animals. 
For example, zoos and related animal facilities, prairie dog relocation 
services, and research labs may request permission to import, capture, 
transport, or sell listed animals, and, if permission is granted, they 
may continue such activities that would otherwise be prohibited by the 
June 11, 2003, order. Generating quantitative estimates of the cost 
savings from such permits is not possible because of the uncertainty 
associated with how and when such permits would be granted. While these 
exemptions may in principle pose some risks, we believe that these are 
negligible because permits would be granted only in instances where 
prohibited activities pose minimal risk of establishing or spreading 
the monkeypox virus.

E. Alternatives

    Sound economic analysis requires an assessment of reasonable 
alternatives. The key alternative, and one on which we solicit comment, 
is a ``sunset'' provision ending the domestic restrictions by January, 
2004, unless we made a determination that the ban was necessary to 
protect health and safety. The economic advantage of this alternative 
relative to this interim final rule may be the elimination of 
permitting costs for capturing, transporting, selling, bartering, 
exchanging, distributing, or releasing an animal that has been only a 
conduit and not a source of infection, as well as allowing for 
resumption of a prairie dog market as existed before the disease. It 
may, however, provide for later capture, transport, sale, barter, 
exchange, distribution, or release of an animal that may carry other 
diseases.
    We also considered whether it would be possible to devise a 
regulatory program that would allow for testing and certification of 
animals, whereby animals that had been certified to be free of the 
monkeypox virus would not be subject to the rule's prohibitions. We did 
not pursue this alternative because studies are being conducted to 
determine the incubation period in various animal species and the 
manner in which the virus may be transmitted. In other words, 
scientific knowledge about monkeypox is still evolving, so it may be 
unlikely that a quick, reliable testing method, particularly when 
incubation periods and the extent to which animals may be asymptomatic 
carriers of the monkeypox virus are unknown, will be developed in the 
immediate future.
    Assessment of other alternatives is limited because the interim 
final rule would allow exceptions to the prohibited activities provided 
that parties have Federal permits. The specific criteria for these 
exceptions have not been determined, but can be expected to include 
those activities that pose no risk of establishing or spreading the 
monkeypox virus.

F. Benefits

    A recent report indicates that 71 cases of monkeypox in humans have 
been reported in Illinois, Indiana, Kansas, Ohio, Missouri, and 
Wisconsin (Ref. 4). Detailed clinical information was available for 30 
cases reported in Illinois and Wisconsin. Among these, the

[[Page 62364]]

earliest reported onset of illness was on May 15, 2003. For the 
majority of patients (22 (73 percent)), a febrile illness has either 
preceded or accompanied the onset of a papular rash; respiratory 
symptoms (16 (64 percent)), lymphadenopathy (14 (47 percent)), and sore 
throat (10 (33 percent)) also were prominent signs and symptoms. The 
rash typically progressed through stages of vesiculation, pustulation, 
umbilication, and encrustation. Early lesions became ulcerated in some 
patients. Rash distribution and lesions have occurred on the head, 
trunk, and extremities; many patients had initial and satellite lesions 
on palms, soles, and extremities. Rashes were generalized in some 
patients. No fatalities have yet been reported in the United States 
although the case fatality rate in remote and medically underserved 
areas of Africa is between 1 percent and 10 percent (Ref. 26).
    We lack data to estimate the value in monetary terms that people 
might assign to specific reductions in the risk of monkeypox 
infections.
    This rule would also reduce the risk to public health that would 
result if monkeypox became endemic in the United States. (An 
``endemic'' disease is one that is confined to or characteristic of a 
particular locality.) The potential risks to humans from exposure to 
monkeypox established among wild animal populations would be 
potentially large if the disease were not controlled. Inadvertent 
contact between infected pets and wild animals could spread monkeypox 
into established wild animal populations, causing widespread disruption 
to ecosystems and potentially exposing large numbers of people to a new 
infectious agent. In Africa, serologic evidence of monkeypox infection 
has been found in a wide variety of nonhuman primates, rodents, and 
squirrels; monkeypox virus has been isolated from a species of squirrel 
in Zaire, but the role of any particular species as a reservoir has not 
been established. Some species of primates, rodents, and lagomorphs 
(such as rabbits) are known to be susceptible. Although no infections 
have been previously reported in dogs or cats, these species may also 
be susceptible to monkeypox (Ref. 27). Thus, there is significant risk 
that common, native mammalian species, such as squirrels and rabbits, 
could become reservoirs of this new disease if it were released into 
the environment. CDC has reported that a pet rabbit treated at a 
veterinary clinic that also had an infected prairie dog became ill and 
died. The rabbit died spontaneously, but the owner of that rabbit 
became ill with a disease compatible with the clinical description of 
monkeypox; however, the rabbit owner was not a laboratory-confirmed 
case (Ref. 28). This rule would reduce the risk of the monkeypox virus 
spreading among both species known to carry it, as well as the 
possibility of it spreading through wild and pet species currently not 
known to carry it.
    Because this interim final rule would be expected to reduce the 
frequency of monkeypox outbreaks, there would also be a commensurate 
reduction in outbreak traceback efforts by the Federal Government, as 
well as possible state and local government efforts. The costs of these 
traceback efforts would vary depending on the size of the outbreak.

G. Costs

    The costs of this interim rule are the lost value to consumers and 
producers associated with not being able to import, capture, transport, 
sell, barter, exchange, distribute, or release prairie dogs and certain 
African rodents. We believe that the costs are not likely to be high, 
because the monkeypox outbreak has already sharply curtailed the trade 
in prairie dogs, as described above. This curtailment occurred prior to 
Federal regulatory action. Unfortunately, we lack data on the magnitude 
of trade that has occurred since the outbreak was publicized in June, 
and so we present instead data from before the outbreak. These data 
overstate the costs of the rule insofar as they ignore the reduction in 
volume of trade likely already to have resulted from the outbreak 
itself. Indeed, if the data shown in Figure 1 are representative of 
broader and long-lasting market conditions, then the interim final 
rule's prohibition has no impact on sales of prairie dogs as pets 
because trade has vanished as a result of the outbreak. If the trade in 
prairie dogs would otherwise have resumed in the absence of this order, 
then costs would occur. Although we do not have trade data for the 
other listed animals during the same periods, we surmise that similar 
reductions in trade of these animals has also occurred.
    Generally, the trade in prairie dogs falls into several categories. 
In terms of volume, the largest category with the greatest number of 
animals traded involves the market for pets. There are currently about 
10 to 15 million prairie dogs in the United States (Ref. 29). In 2001, 
30,000 prairie dogs were sold for pets (Ref. 30). About 15,000 of the 
30,000 sold were captured in Texas by registered dealers (Ref. 31). 
Some 15,000 are exported annually (Ref. 29). Sales over the last few 
years have remained relatively constant, with sales and prices slightly 
down since Japan, the largest foreign market, banned importation of 
prairie dogs on March 1, 2003.
    Typically, pet stores purchase prairie dogs from dealers for $50 to 
$60 each, and re-sell to pet owners for about $150 each (Ref. 32). If 
average retail prices of prairie dogs were $150 prior to the monkeypox 
outbreak, annual prairie dog sales in the pet market would appear to be 
$4.5 million, although this estimate must be seen as very approximate 
because it is based on a market survey.
    A ban on the capture, transport, sale, barter, exchange, 
distribution, or release of prairie dogs would have a noticeable effect 
on prairie dog trappers who supply the pet market, if it occurred in 
the absence of an outbreak. Prairie dog trappers would not be expected 
to incur serious economic effects this year because the peak of the 
prairie dog sales season (April through June 1) has passed (Ref. 32). A 
permanent prohibition on transportation of prairie dogs, however, could 
have a very serious effect. Suppliers of pet supplies and equipment 
intended for prairie dogs and the other small, listed rodents may also 
be affected by this action, but we believe such effects will be small 
because this equipment may also be suitable for some other mammalian 
pets, such as hamsters or guinea pigs.
    A variety of relocation activities involving prairie dogs are 
undertaken in part because the Federal Fish and Wildlife Service has 
assigned at least one prairie dog species a status of ``warranted'' 
under the Endangered Species Act. Many of these activities already 
require permits from State agencies (Ref. 33). We lack information on 
the scope or magnitude of such activities or how they might be affected 
by the June 11, 2003, order or by this rule, but would expect some of 
them to qualify for exemptions.
    Another category of trade affected by this rule is zoos, which 
routinely trade animals for a variety of purposes, although we lack 
information about the extent of trade in prairie dogs or African 
rodents. The American Zoo and Aquarium Association (AZA) is the largest 
zoo and aquarium organization in the world. The AZA's mission is to 
establish, uphold, and raise the highest zoological and aquarium 
industry standards. It has accredited over 200 organizations, of which 
about 170 are zoos in the United States. As of June 6, 2003, about 79 
zoos in the United States held 758 prairie dogs according to a survey 
of data at the website for the International Species Information

[[Page 62365]]

System.\3\ We recognize that AZA has an accreditation process for 
institutions such as zoological parks, and a separate certification 
process for related facilities, such as wildlife refuges, conservation 
research facilities, survival or rehabilitation centers, breeding 
farms, and educational organizations (Ref. 34). AZA accreditation 
requires that institutions follow the guidelines of the American 
Association of Zoo Veterinarians regarding medical programs and zoo 
hospitals.
---------------------------------------------------------------------------

    \3\ The International Species Information System (ISIS) 
maintains a computer-based information system for wild animal 
species held in captivity. The database contains information on ten 
thousand species held in 586 institutions in 72 countries on 6 
continents. Roughly 250 of these institutions are professionally 
managed United States zoos, most of which have been accredited by 
AZA. The ISIS Web site allows web-based searches by species and is 
updated weekly (see International Species Information System (ISIS); 
conversation with Mr. Nate Flesness, ISIS director; ISIS Web site 
information (www.ISIS.org)). ISIS is located in Apple Valley, 
Minnesota.
---------------------------------------------------------------------------

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

[[Page 62366]]

unless we determine that the ban was necessary to protect health and 
safety. The economic advantage of this alternative relative to this 
interim final rule may be the elimination of permitting costs for 
transport in domestic animals in the case that monkeypox has not become 
endemic. It may, again, provide for later capture, transport, sale, 
barter, exchange, distribution, or release of an animal that may carry 
other diseases. This alternative was not accepted because of the 
uncertainty in predicting when a ban would no longer be necessary.
    A second alternative would have been to allow the continued 
capture, transport, sale, barter, exchange, distribution, or release of 
the listed animals, effectively doing nothing to reduce the risk of 
further spread of monkeypox. Although the market for at least prairie 
dogs was apparently greatly reduced due to public knowledge of the 
monkeypox issue and seasonal variation in the prairie dog market, this 
option would have allowed those few in the market that dismissed the 
severity of the problem to continue to pose a risk that monkeypox would 
become endemic to domestic pets and wildlife and further affect human 
health. For this reason it was determined to be not acceptable.
    A third alternative would have been to exempt small businesses from 
this interim final rule. However, because about 94 percent of pet 
stores and probably a large portion of small animal trappers and 
wholesalers/distributors are small businesses, this option would have 
compromised the rule's ability to reduce the risk of establishing or 
spreading the monkeypox virus in the United States.

VII. Paperwork Reduction Act of 1995

    This interim final rule contains information collections that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). A 
description of these provisions is given below with an estimate of the 
annual reporting burden. Included in the estimate is the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    Both FDA and CDC have requested emergency processing of this 
proposed collection of information under section 3507(j) of the PRA (44 
U.S.C. 3507(j) and 5 CFR 1320.13). Such emergency processing is 
necessary in order to respond immediately to the monkeypox outbreak. 
This interim final rule, at 21 CFR 1240.63(a)(2)(ii)(A) and (B) and 42 
CFR 71.56(a)(2)(i) and (ii), contains information collection 
requirements. In compliance with the PRA (44 U.S.C. 3507(d)), we have 
submitted a copy of the information collection provisions of this 
interim final rule to OMB for review.
    The information collections in this interim final rule have been 
approved under OMB control number 0910-0519 (for 21 CFR 1240.63) and 
OMB control number 0920-0615 (for 42 CFR 71.56). An agency may not 
conduct or sponsor and a person is not required to respond to a 
collection of information unless it contains a currently valid OMB 
control number.
    Title: Control of Communicable Diseases; Requests for Exemptions 
from the Restrictions on African Rodents, Prairie Dogs, and Certain 
Other Animals.
    Description: Monkeypox is a rare zoonotic viral disease that occurs 
primarily in the rain forest countries of central and west Africa. 
Studies have shown that infected rodents are capable of transmitting 
the monkeypox virus to humans. Limited person-to-person spread of 
infection has been reported in disease-endemic areas in Africa. It is 
likely the virus is entering the United States by way of rodent species 
imported from Africa. Further transmission of the virus likely occurred 
in the storage and handling of these rodents during sale and 
distribution within the United States. This resulted in secondary 
transmission to domestic prairie dogs in this country housed in the 
same animal-holding facility or pet shop. Introduction of exotic 
species, such as African rodents, poses a serious public health threat 
because of the potential of human monkeypox virus infection. Transport, 
sale, or any other type of distribution, including release into the 
environment, of certain species of rodents poses a serious public 
health threat because of the potential for further spread of the 
monkeypox virus to other animal species and to humans. To prevent the 
establishment and spread of the monkeypox virus in the United States, 
we are prohibiting the capture, offer to capture, transport, offer to 
transport, sale, barter, or exchange, offer to sell, barter, or 
exchange, distribution, offer to distribute, or release into the 
environment of prairie dogs and certain rodents and any other animal so 
prohibited by order of the Commissioner of Food and Drugs. We are also 
prohibiting the importation of all rodents that were obtained, directly 
or indirectly, from Africa, or whose native habitat is Africa, or any 
other animal whose importation the Director of CDC has prohibited by 
order. The rule provides for exemptions from these prohibitions and 
discusses our authority to issue orders causing an animal to be 
quarantined, re-exported, or destroyed. The information collection 
burden is associated with the process for seeking an exemption.
    Description of Respondents: Persons who capture, offer to capture, 
transport, offer to transport, sell, barter, or exchange, offer to 
sell, barter, or exchange, distribute, offer to distribute, import, 
offer to import, or release into the environment certain rodents.

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                  Annual Frequency     Total No. of     Hours per
       CFR Section          No. of Respondents      per Response        Responses       Response     Total Hours
----------------------------------------------------------------------------------------------------------------
21 CFR                             60                    1                       60             2           120
 1240.63(a)(2)(ii)(A) and
 (B)
----------------------------------------------------------------------------------------------------------------
42 CFR 71.56(a)(2)(i) and          12                    1                       12       0.5-1.0            10
 (ii)
----------------------------------------------------------------------------------------------------------------
                           ....................  ..................  ...............        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 experience to date with the June 11, 
2003, order and on similar requests under FDA regulations. To estimate 
the number of respondents, we examined the number of requests and 
inquiries we have received since the June 11, 2003, order. Both FDA and 
CDC have received fewer than 10 requests, and most requests involved 
requests to move an animal from one location to another. (FDA also has 
received many inquiries.)

[[Page 62367]]

 As we cannot predict how the monkeypox outbreak will be resolved, we 
will tentatively estimate that there will be 60 respondents for FDA's 
provisions and 10 respondents for CDC's provisions. Furthermore, based 
on FDA's experience with submissions seeking exemptions or waivers, we 
will tentatively estimate that each respondent will need 2 hours to 
complete its request for an exemption. Therefore, the total reporting 
burden under 21 CFR 1240.63(a)(2)(ii)(A) and (B) will be 120 hours (60 
respondents x 2 hours per response = 120 hours).
    CDC's estimates for the burden of its data collection are based on 
its experience with the importation of non-human primates. CDC 
estimates that there will be 12 respondents annually for this data 
collection. Respondents will include individuals, businesses, and 
organizations. Although CDC estimates that most respondents will submit 
only one request per year, CDC feels that organizations may submit 2 
requests per year. Individuals and businesses submitting requests will 
need 30 minutes to prepare the request. Organizations will need 1 hour 
to prepare an initial request and 10 minutes for subsequent requests. 
The total annualized burden under 42 CFR 71.56(a)(2)(i) and (ii) will 
be 10 hours.
    The requirements contained in 21 CFR 1240.63(c) and 42 CFR 71.56(c) 
are not subject to review by OMB because they are exempted under 5 CFR 
Sec.  1320(a)(4), which exempts ``administrative actions * * * 
involving an agency against specific individuals or entities.''

VIII. Federalism

    We have analyzed this interim final rule in accordance with the 
principles set forth in Executive Order 13132 and have determined that 
the rule has federalism implications. Federal restrictions on the 
capture, offering to capture, transport, offering to transport, sale, 
barter, or exchange, or offering to sell, barter, or exchange, 
distribution, offering to distribute, or release into the environment 
of certain rodents and prairie dogs are both necessary and appropriate 
to prevent the establishment and spread of monkeypox virus in the 
United States. In accordance with section 361(e) of the PHS act (42 
U.S.C. 264(e)), nothing in this interim final rule supersedes any 
provisions of State or local law except to the extent that such a 
provision conflicts with this interim final rule. For example, the 
interim final rule does not prevent a State from taking stronger 
measures to deal with infected or possibly infected animals or to cover 
additional species. Furthermore, while some States have issued orders 
with restrictions that cover fewer animal species, those State 
requirements do not conflict with the interim final rule and would also 
not be superseded. However, in accordance with section 361(e) of the 
PHS act, any State or local law that would permit any activity 
prohibited under this interim final rule would be in conflict with this 
rule and, therefore, would be superseded.
    We note that we have been in direct contact with many States 
regarding the June 11, 2003, order and efforts to prevent the spread of 
monkeypox. We believe that the public health requires us to give this 
regulation immediate effect. Through this interim final rule, and under 
to section 4(e) of Executive Order 13132, we are providing all affected 
State, local, and tribal officials notice and opportunity to 
participate in this rulemaking.

IX. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

X. References

    The following references have been placed on display in the 
Division of Dockets Management and may be seen by interestes persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Khodakevich, L., Jezek, Z. and Messinger, D., ``Monkeypox 
Virus: Ecology and Public Health Significance,'' Bulletin of the 
World Health Organization, 66: 747-752, 1988. This reference 
identifies several species of squirrels as playing a major role as a 
reservoir for the monkeypox virus.
    2. Centers for Disease Control and Prevention, ``Updated Interim 
Case Definition for Human Case of Monkeypox,'' dated July 2, 2003 
(available through www.cdc.gov/ncidod/monkeypox). FDA has verified 
the Web site addresses in this document, but FDA is not responsible 
for any subsequent changes to the Web site after this document 
publishes in the Federal Register.
    3. Centers for Disease Control and Prevention, ``Questions and 
Answers About Monkeypox,'' dated July 7, 2003 (available through 
www.cdc.gov/ncidod/monkeypox).
    4. Centers for Disease Control and Prevention, ``Update: 
Multistate Outbreak of Monkeypox--Illinois, Indiana, Kansas, 
Missouri, Ohio, and Wisconsin, 2003,'' Morbidity and Mortality 
Weekly Report, 52: 642-646 (July 11, 2003)
    5. State of Colorado, Wildlife Commission, ``Emergency 
Regulation,'' dated July 10, 2003.
    6. State of Illinois, ``Executive Order in Response to Orthopox 
Outbreak,'' dated June 7, 2003.
    7. State of Indiana, Board of Animal Health, Emergency Rule, 
dated June 9, 2003.
    8. State of Michigan, Department of Community Health, ``Order 
Finding Imminent Danger to the Public Health and Requiring 
Corrective Action,'' dated June 13, 2003, and later amended on June 
27, 2003.
    9. State of North Dakota, State Board of Animal Health, ``In the 
matter of: Monkeypox in Prairie Dogs and Gambian Giant pouched 
Rats,'' Order No. 2003-04, dated June 11, 2003.
    10. State of Wisconsin, Department of Agriculture, Trade, and 
Consumer Protection, ``Emergency Rule,'' dated June 9, 2003.
    11. State of Wisconsin, Department of Health and Family 
Services, ``Emergency Order - June 12, 2003,'' dated June 12, 2003.
    12. Order dated June 11, 2003, signed by Julie Louise 
Gerberding, Director, Centers for Disease Control and Prevention, 
and Mark B. McClellan, Commissioner of Food and Drugs, titled 
``Joint Order of the Centers for Disease Control and Prevention and 
the Food and Drug Administration, Department of Health and Human 
Services.
    13. 68 FR 36566, June 18, 2003.
    14. Centers for Disease Control and Prevention, ``Update: 
Multistate Outbreak of Monkeypox-- Illinois, Indiana, Kansas, 
Missouri, Ohio, and Wisconsin, 2003,'' Morbidity and Mortality 
Weekly Report, 52: 616-618, July 4, 2003, (describing how animal 
laboratory testing demonstrated that a Gambian giant pouched rat, 
three dormice, and two rope squirrels from an April 9, 2003, 
shipment of animals from Ghana were infected with the monkeypox 
virus).
    15. North Carolina Department of Health and Human Services, 
``State Health Official Reminds Public Not to Release Prairie Dogs 
Into the Wild,'' dated June 19, 2003.
    16. Colorado Division of Wildlife, ``Wildlife Report: Black-
Footed Ferrets Back in Colorado,'' dated November 19, 2001 
(available at www.dnr.state.co.us/cdr_news/wildlife/
2001111985112.htm).
    17. Food and Drug Administration and Centers for Disease Control 
and Prevention, ``Wild-to-Wild Translocation or Transportation of 
Prairie Dogs'' (undated).
    18. Centers for Disease Control and Prevention, ``Interim 
Guidance to State and Local Governments for the Removal of State- 
and Locally Imposed Quarantine Orders and the Euthanasia of Animals 
Affected by the Monkeypox Outbreak,'' dated July 1, 2003.
    19. Centers for Disease Control and Prevention, ``Questions and 
Answers: Quarantine and Euthanasia of Animals Affected by the 
Monkeypox Outbreak,'' dated July 10, 2003.
    20. Fish and Wildlife Service, ``Notice to the Wildlife Import/
Export Community,'' dated June 11, 2003 (describing import and 
export prohibitions on certain rodents, including any rodents from 
Africa, whether alive or dead, for any purpose).
    21. Peeters, M., et al., ``Risk to Human Health from a Plethora 
of Simian

[[Page 62368]]

Immunodeficiency Viruses in Primate Bushmeat,'' Emerging Infectious 
Diseases, 8: 451-457 (May, 2002) (showing that humans who hunt and 
handle bushmeat are exposed to many viruses).
    22. Downie, A.W., and Dumbell, K. R., ``Survey of Variola Virus 
in Dried Exudate and Crusts from Smallpox Patients,'' Lancet, 1: 
550-3, 1947.
    23. Woodruffe, G. M., ``The Heat Inactivation of Vaccinia 
Virus,'' Virology, 10: 379-82 (1960).
    24. http://www.cdc.gov/od/oc/media/wncount.htm.
    25. Wisconsin Division of Public Health, Press Release: ``6/6/
03, Wisconsin Division of Public Health Bans Sale of Prairie 
Dogs.
    26. Centers for Disease Control and Prevention, ``Multistate 
Outbreak of Monkeypox - Illinois, Indiana and Wisconsin,'' Morbidity 
and Mortality Weekly Report, 52: 537-540, June 13, 2003.
    27. Centers for Disease Control and Prevention, ``Monkypox 
Infections in Animals: Updated Interim Guidance for Veterinarians,'' 
dated July 22, 2003 (available through http://www.cdc.gov/ncidod/
monkeypox/pdf/mpoxanimalguidance.pdf).
    28. Centers for Disease Control and Prevention, ``CDC 
Telebriefing Transcript: Monkeypox Investigation,'' dated June 7, 
2003 (available through http://www.cdc.gov/od/oc/media/transcripts/
t030607.htm).
    29. Data Source: ``Pet Your Prairie Dog,'' Wall Street Journal, 
posted April 24, 2003. This article can be found at http://
www.twincities.com/mld/twincities/living/5698532.htm.
    30. Data Source: http://www.prairiedog.info/prairie--dog--
reintroduction.htm.
    31. Robert E Pierre, ``Newfound Scrutiny for a Pest to Some, a 
Beloved Pet to Others,'' Washington Post, June 11, 2003. Page A-03.
    32. Phone conversation with prairie dog trapper in Lubbock, 
Texas, on June 16, 2003.
    33. U.S. Fish and Wildlife Service, Mountain-Prairie Region, 
``Black Tailed Prairie Dog-The Black-tailed Prairie Dog Conservation 
Assessment and Strategy,'' dated September 9, 1999 (available 
through http://www.r6.fws.gov/btprairiedog/
conassstrat.htm[numsign]strategy).
    34. http://www.aza.org/Accreditation/[numsign]acc.
    35. 2003 2004 QPPMA National Pet Owners Survey, American Pet 
Product
    36. Axtman, K., ``The Prairie Dog: Pest or Pet?,'' The Christian 
Science Monitor, August 13, 2002, taken from the web on June 12, 
2003, from http://www.csmonitor.com/2002/0813/p03s01-usgn.html.
    37. Exotic Pets.com, taken from http://www.exoticpets.com/Show_
Ads.asp?petid=16 on June 12, 2003.
    38. Hutin, Y. J. F., et al., ``Outbreak of Human Monkeypox, 
Democratic Republic of Congo, 1996-1997,'' Emerging Infectious 
Diseases, 7:434-438 (May through June, 2001).

List of Subjects

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 1240

    Communicable diseases, Public health, Travel restrictions, Water 
supply.

42 CFR Part 71

    Airports, Animals, Communicable diseases, Harbors, Imports, 
Pesticides and pests, Public health, Quarantine, Reporting and 
recordkeeping requirements.

0
Therefore, under the Public Health Service Act and under authority 
delegated to the Commissioner of Food and Drugs and to the Director, 
Centers for Disease Control and Prevention, 21 CFR parts 16 and 1240 
and 42 CFR part 71 are amended as follows:

21 CFR CHAPTER I

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
1. The authority citation for 21 CFR Part 16 continues to read as 
follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

0
2. Section 16.1 is amended in paragraph (b)(2) by numerically adding an 
entry for Sec.  1240.63(c)(3) to read as follows:


Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (2) * * *
    Sec.  1240.63(c)(3), relating to a written order to cause an animal 
to be placed in quarantine or to cause an animal to be destroyed.
* * * * *

PART 1240--CONTROL OF COMMUNICABLE DISEASES

0
3. The authority citation for 21 CFR part 1240 continues to read as 
follows:

    Authority: 42 U.S.C. 216, 243, 264, 271.
0
4. Section 1240.63 is added to subpart D to read as follows:


Sec.  1240.63  African rodents and other animals that may carry the 
monkeypox virus.

    (a) What Actions Are Prohibited? What Animals Are Affected?
    (1) Except as provided in paragraph (a)(2) of this section,
    (i) You must not capture, offer to capture, transport, offer to 
transport, sell, barter, or exchange, offer to sell, barter, or 
exchange, distribute, offer to distribute, or release into the 
environment, any of the following animals, whether dead or alive:
    (A) Prairie dogs (Cynomys sp.),
    (B) African Tree squirrels (Helioscirurus sp.),
    (C) Rope squirrels (Funisciurus sp.),
    (D) African Dormice (Graphiurus sp.),
    (E) Gambian giant pouched rats (Cricetomys sp.),
    (F) Brush-tailed porcupines (Atherurus sp.),
    (G) Striped mice (Hybomys sp.), or
    (H) Any other animal so prohibited by order of the Commissioner of 
Food and Drugs because of that animal's potential to transmit the 
monkeypox virus; and
    (ii) You must not prevent, or attempt to prevent, the Food and Drug 
Administration (FDA) from causing an animal to be quarantined or 
destroyed under a written order for the animal's quarantine or 
destruction.
    (2) The prohibitions in paragraph (a)(1) of this section do not 
apply if you:
    (i) Transport an animal listed in paragraph (a)(1) of this section, 
or covered by an order by the Commissioner of Food and Drugs, to 
veterinarians or animal control officials for veterinary care, 
quarantine, or destruction purposes; or
    (ii) Have written permission from FDA to capture, offer to capture, 
transport, offer to transport, sell, barter, or exchange, offer to 
sell, barter, or exchange, distribute, offer to distribute, and/or 
release into the environment an animal listed in paragraph (a)(1) of 
this section, or covered by an order by the Commissioner of Food and 
Drugs. You may not seek written permission to sell, barter, or 
exchange, or offer to sell, barter, or exchange, as a pet, an animal 
listed in paragraph (a)(1) of this section or covered by an order by 
the Commissioner of Food and Drugs.
    (A) To obtain such written permission from FDA, you must send a 
written request to the Division of Compliance (HFV-230), Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, Attn: Listed Animal Permit Official. You may also 
fax your request to the Division of Compliance (using the same address 
in the previous sentence) at 301-827-1498.
    (B) Your request must state the reasons why you need an exemption, 
describe the animals involved, describe the number of animals involved, 
describe how the animals will be transported (including carrying 
containers or cages, precautions for handlers, types of vehicles used, 
and other procedures to minimize exposure of animals and precautions to 
prevent animals from escaping into the environment), describe any 
holding facilities, quarantine procedures, and/or veterinarian 
evaluation involved in the animals' movement, and explain why an

[[Page 62369]]

exemption will not result in the spread of monkeypox within the United 
States.
    (C) We (FDA) will respond, in writing, to all requests, and we also 
may impose conditions in granting an exemption.
    (b) What Actions Can FDA Take?
    (1) To prevent the monkeypox virus from spreading and becoming 
established in the United States, we may, in addition to any other 
authorities under this part:
    (i) Issue an order causing an animal to be placed in quarantine,
    (ii) Issue an order causing an animal to be destroyed, or
    (iii) Take any other action necessary to prevent the spread of the 
monkeypox virus.
    (2) Any order to cause an animal to be placed in quarantine or to 
cause an animal to be destroyed will be in writing.
    (c) How Do I Appeal an Order?
    (1) If you receive a written order to cause an animal to be placed 
in quarantine or to cause an animal to be destroyed, you may appeal 
that order. Your appeal must be in writing and be submitted to the Food 
and Drug Administration District Director whose office issued the 
order, and you must submit the appeal within two business days after 
you receive the order.
    (2) As part of your appeal, you may request an informal hearing. 
Your appeal must include specific facts showing there is a genuine and 
substantial issue of fact that requires a hearing.
    (3) If we grant your request for an informal hearing, we will 
follow the regulatory hearing requirements at in part 16, except that:
    (i) The written order will serve as notice of opportunity for that 
hearing, for purposes of Sec.  16.22(a) of this chapter;
    (ii) The presiding officer will issue a decision rather than a 
report and a recommended decision. The presiding officer's decision 
constitutes final agency action.

42 CFR CHAPTER I

PART 71-FOREIGN QUARANTINE

0
5. The authority citation for 42 CFR part 71 continues to read as 
follows:

    Authority: Secs. 215 and 311 of the Public Health Service (PHS) 
Act, as amended (42 U.S.C. 216, 243), secs. 361-369, PHS Act, as 
amended (42 U.S.C. 264-272).

0
6. Section 71.56 is added to subpart F read as follows:


Sec.  71.56  African rodents and other animals that may carry the 
monkeypox virus.

    (a) What Actions Are Prohibited? What Animals Are Affected?
    (1) Except as provided in paragraphs (a)(2) and (a)(3) of this 
section,
    (i) You must not import or attempt to import any rodents, whether 
dead or alive, that were obtained, directly or indirectly, from Africa, 
or whose native habitat is Africa, any products derived from such 
rodents, any other animal, whether dead or alive, whose importation the 
Director has prohibited by order, or any products derived from such 
animals; and
    (ii) You must not prevent or attempt to prevent the Centers for 
Disease Control and Prevention (CDC) from causing an animal to be 
quarantined, re-exported, or destroyed under a written order.
    (2) The prohibitions in paragraph (a)(1) of this section do not 
apply if you have written permission from CDC to import a rodent that 
was obtained, directly or indirectly, from Africa, or whose native 
habitat is Africa, or an animal whose importation the Director has 
prohibited by order.
    (i) To obtain such written permission from CDC, you must send a 
written request to Division of Global Migration and Quarantine, 
National Center for Infectious Diseases, Centers for Disease Control 
and Prevention, 1600 Clifton Rd., Atlanta, GA 30333. You may also fax 
your request to the Division of Global Migration and Quarantine (using 
the same address in the previous sentence) at 404-498-1633.
    (ii) Your request must state the reasons why you need an exemption, 
describe the animals involved, describe the number of animals involved, 
describe how the animals will be transported (including carrying 
containers or cages, precautions for handlers, types of vehicles used, 
and other procedures to minimize exposure of animals and precautions to 
prevent animals from escaping into the environment), describe any 
holding facilities, quarantine procedures, and/or veterinarian 
evaluation involved in the animals' movement, and explain why an 
exemption will not result in the spread of monkeypox within the United 
States. Your request must be limited to scientific, exhibition, or 
educational purposes.
    (iii) We will respond in writing to all requests, and we also may 
impose conditions in granting an exemption. If we deny your request, 
you may appeal that denial. Your appeal must be in writing and be 
submitted to the CDC official whose office denied your request, and you 
must submit the appeal within two business days after you receive the 
denial. Your appeal must state the reasons for the appeal and show that 
there is a genuine and substantial issue of fact in dispute. We will 
issue a written response to the appeal, which shall constitute final 
agency action.
    (3) The prohibitions in paragraph (a) of this section do not apply 
to products derived from rodents that were obtained, directly or 
indirectly, from Africa, or whose native habitat is Africa, or products 
derived from any other animal whose importation the Director has 
prohibited by order if such products have been properly processed to 
render them noninfectious so that they pose no risk of transmitting or 
carrying the monkeypox virus. Such products include, but are not 
limited to, fully taxidermied animals and completely finished trophies; 
and they may be imported without written permission from CDC.
    (b) What Actions Can CDC Take?
    (1) To prevent the monkeypox virus from spreading and becoming 
established in the United States, we may, in addition to any other 
authorities under this part:
    (i) Issue an order causing an animal to be placed in quarantine,
    (ii) Issue an order causing an animal to be re-exported,
    (iii) Issue an order causing an animal to be destroyed, or
    (iv) Take any other action necessary to prevent the spread of the 
monkeypox virus.
    (2) Any order causing an animal to be quarantined, re-exported, or 
destroyed will be in writing.
    (c) How Do I Appeal an Order? If you received a written order to 
quarantine or re-export an animal or to cause an animal to be 
destroyed, you may appeal that order. Your appeal must be in writing 
and be submitted to the CDC official whose office issued the order, and 
you must submit the appeal within 2 business days after you receive the 
order. Your appeal must state the reasons for the appeal and show that 
there is a genuine and substantial issue of fact in dispute. We will 
issue a written response to the appeal, which shall constitute final 
agency action.

    Dated: October 6, 2003.
Tommy G. Thompson,
Secretary of Health and Human Services.
[FR Doc. 03-27557 Filed 11-3-03; 8:45 am]
BILLING CODE 4160-01-S