[Federal Register Volume 63, Number 16 (Monday, January 26, 1998)]
[Proposed Rules]
[Pages 3671-3673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1810]



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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 54 and 79

[Docket No. 97-093-1]
RIN 0579-AA90


Interstate Movement of Sheep and Goats From States That Do Not 
Quarantine Scrapie Infected and Source Flocks

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: We are soliciting public comment to help us develop options 
for potential changes to our regulations for the interstate movement of 
sheep and goats. We believe changes may be necessary to improve control 
and limit the spread of scrapie, a serious disease of sheep and goats. 
After evaluating public comment on the issues presented in this notice, 
we will determine whether proposing changes to our regulations is 
necessary.

DATES: Consideration will be given only to comments received on or 
before March 27, 1998.

ADDRESSES: Comments may be submitted as paper copies or through the 
World Wide Web. If you submit paper copies, please send an original and 
three copies of your comments to Docket No. 97-093-1, Regulatory 
Analysis and Development, PPD, APHIS, suite 3C03, 4700 River Road Unit 
118, Riverdale, MD 20737-1238. Please state that your comments refer to 
Docket No. 97-093-1. We encourage the submission of copies through the 
World Wide Web, since this both facilitates our analysis of the 
comments and allows us to make the text of comments available to the 
public via the Internet. The Web page address for comments on this 
proposed rule is http://www.aphis.usda.gov/ppd/scrapie. This Web page 
also contains copies of the proposed rule in several formats and links 
to related information. Please be sure to include your full name and 
organization in any comments you submit via the Web. If your Web 
comment is a duplicate of a paper copy you have submitted, please state 
this in the first line of your Web message. Both paper and Web comments 
received may be inspected at USDA, room 1141, South Building, 14th 
Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 
4:30 p.m., Monday through Friday, except holidays. Persons wishing to 
inspect comments are requested to call ahead on (202) 690-2817 to 
facilitate entry into the comment reading room.

FOR FURTHER INFORMATION CONTACT: Dr. Joseph VanTiem, Senior Staff 
Veterinarian, National Animal Health Programs, VS, APHIS, 4700 River 
Road Unit 46, Riverdale, MD 20737-1231, (301) 734-7716.

SUPPLEMENTARY INFORMATION:

Background

    Scrapie is a degenerative and eventually fatal disease affecting 
the central nervous systems of sheep and goats. Its control is 
complicated because the disease often has an extremely long incubation 
period without clinical signs of disease, and because there is no 
validated live-animal test for the disease.
    Scrapie is the prototype of the group of diseases known as the 
transmissible spongiform encephalopathies (TSEs). These diseases are 
caused by a transmissible agent which is yet to be fully characterized. 
TSEs share the following common characteristics:
     A prolonged incubation period of months or years;
     A progressive debilitating neurological illness that is 
always fatal;
     When examined by electron microscopy, detergent treated 
extracts of brain tissue from animals or humans affected by these 
diseases reveal the presence of scrapie associated fibrils;
     Pathological changes are confined to the central nervous 
system and include vacuolation, astrocytosis, and glyosis. Amyloid 
plaques may be seen, especially in mice and hamsters; and
     The transmissible agent elicits no detectable specific 
immune response in the host.
    Several recent scientific findings are relevant to the 
understanding and control of scrapie. While there is still no validated 
live animal test for scrapie, a recent study conducted in The 
Netherlands (Schreuder et al., 1996) indicates that immunohistochemical 
analysis of tonsil samples may be useful in detecting scrapie in sheep 
prior to the onset of clinical signs. The Animal and Plant Health 
Inspection Service (APHIS) is currently completing a pilot study to 
harvest various tissues (tonsil, head lymph nodes, and brain) from 
mature sheep at slaughter and then test them using immunohistochemistry 
to ascertain if the partially protease-resistant form of the prion 
protein (PrPsc--the protein associated with scrapie) may be routinely 
detected in the preclinical animal. If this proves to be an effective 
method of surveillance, it may prove useful as a screening tool and 
facilitate tracebacks to infected flocks.
    In addition to the possibility that a validated live-animal test 
for scrapie may be developed, genetic studies have yielded a greater 
understanding of the role of specific genes in determining the 
incubation period of scrapie in sheep. However, there is still much to 
be determined about the role of genetics in scrapie susceptibility. A 
key question is whether certain genotypes fully prevent scrapie 
infection, or merely protect against clinical manifestation in an 
animal while possibly allowing the animal to serve as a carrier of 
scrapie.
    While these advances may come to significantly affect the control 
of scrapie, current control programs rely largely on postmortem 
diagnosis of scrapie, traceback of animal movements, and certification 
of flocks' scrapie status based on monitoring the flock for scrapie 
over a period of years.
    Current APHIS initiatives concerning scrapie include interstate 
movement regulations in 9 CFR part 79, which restrict the interstate 
movement of certain sheep and goats in order to help control the spread 
of scrapie, and the Voluntary Scrapie Flock Certification Program (the 
Voluntary Program), described in regulations in 9 CFR part 54 and in a 
program standards document entitled ``Uniform Methods and Rules--
Voluntary Scrapie Flock Certification'' (UM&R), which is available at 
http://www.aphis.usda.gov/vs/scrapie/umr. A hard-copy of the UM&R may 
be obtained by contacting the individual listed under FOR FURTHER 
INFORMATION CONTACT.
    APHIS worked with industry to develop the Voluntary Program, under 
which participating flocks follow strict identification, recordkeeping 
and other requirements and may eventually be certified free from 
scrapie. If a flock that is participating in the Voluntary Program is 
identified as an infected flock or source flock, it is removed from the 
program until the flock completes a flock plan. The flock plan calls 
for an epidemiologic investigation to remove high-risk animals from the 
flock and includes other conditions, such as cleaning and disinfection 
of flock premises, educating flock personnel in techniques to recognize 
clinical signs of scrapie and control its spread, and maintaining 
records of animals in the flock.
    The regulations in part 79 also restrict the interstate movement of 
scrapie-positive sheep and goats, and sheep and goats from scrapie 
infected and source flocks. The regulations impose minimal restrictions 
on the interstate movement

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of animals \1\ under 1 year of age destined for slaughter and animals 
marked on the jaw with a 1-inch letter ``S.'' Other animals from 
scrapie infected and source flocks may be moved interstate under 
requirements that limit the further spread of scrapie and make it 
feasible to trace back the movements of animals that are later 
diagnosed with scrapie. These requirements include:

    \1\ Throughout this document, when the term ``animals'' is used, 
it refers only to sheep and goats.
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     The owner of the flock or his or her agent has signed 
an agreement with the Administrator in which the owner of the flock 
or his or her agent agrees to comply with the requirements of 9 CFR 
79.2 until the time the flock is no longer an infected flock or 
source flock.
     The owner of the flock or his or her agent shall 
immediately report to a State representative, APHIS representative, 
or an accredited veterinarian any animals in the flock exhibiting 
the following: weight loss despite retention of appetite; behavioral 
abnormalities; pruritus (itching); wool pulling; biting at legs or 
side; lip smacking; motor abnormalities such as incoordination, high 
stepping gait of forelimbs, bunny hop movement of rear legs, swaying 
of back end; increased sensitivity to noise and sudden movement; 
tremor, ``star gazing,'' head pressing, recumbency, or other signs 
of neurological disease or chronic wasting illness. Such animals 
must not be removed from the flock without written permission of an 
APHIS representative or State representative.
     The owner of the flock or his or her agent shall 
identify all animals 1 year of age or over within the flock. All 
animals less than 1 year of age will be identified when a change of 
ownership occurs, with the exception of those moving within 
slaughter channels. The form of identification shall be an 
electronic implant, flank tattoo, or ear tattoo, providing a unique 
identification number that may be applied by the owner of the flock 
or his or her agent in accordance with instructions by an APHIS 
representative, State representative, or an accredited veterinarian.
     The owner of the flock or his or her agent shall 
maintain, and keep for a minimum of 5 years after an animal dies or 
is otherwise removed from a flock, the following records for each 
animal in the flock: The animal's individual identification number 
from its electronic implant, flank tattoo, or ear tattoo, and any 
secondary form of identification the owner of the flock may choose 
to maintain; sex; breed; date of acquisition and source (previous 
flock), if the animal was not born in the flock; and disposition, 
including the date and cause of death, if known, or date of removal 
from the flock.
     The owner of the flock or his or her agent shall allow 
breed associations and registries, livestock markets, and packers to 
disclose records to APHIS representatives or State representatives, 
to be used to trace source flocks and expose animals.
     The owner of the flock or his or her agent shall make 
animals in the flock and records required to be kept under paragraph 
(a)(2)(iv) of 9 CFR 79.2 available for inspection by APHIS 
representatives and State representatives, given reasonable prior 
notice.
     Upon request of an APHIS representative, the owner of 
the flock or his or her agent will have an accredited veterinarian 
collect and submit tissues from animals reported in accordance with 
paragraph (a)(2)(ii) of 9 CFR 79.2 to a laboratory designated by an 
APHIS representative.

    However, part 79 applies only when flock owners wish to move sheep 
interstate. Part 79 does not restrict the intrastate movement of 
animals from infected and source flocks, and such movement may spread 
scrapie to other animals in a State. If these other animals, which are 
not subject to the restrictions in part 79, then move interstate, 
scrapie could be spread interstate.
    Therefore, there is a risk that scrapie infection that originated 
in an infected or source flock could spread interstate despite part 79. 
This risk is very low where State authorities have imposed quarantines 
on infected and source flocks that keep animals in these flocks from 
contact with other animals. The risk is higher in States that do not 
quarantine scrapie infected and source flocks.
    APHIS does not have statutory authority to require intrastate 
movement restrictions for sheep and goats (unless the Secretary has 
declared an extraordinary emergency). However, APHIS does have 
statutory authority to restrict the interstate movement of animals from 
a State if intrastate movement practices result in a threat of 
spreading disease interstate. We are seeking public input on whether 
and how APHIS should restrict the interstate movement of animals from 
States that do not quarantine infected and source flocks.
    We are examining current interstate movement restrictions both to 
ensure effective domestic control of scrapie and to ensure that our 
domestic interstate restrictions are consistent with our requirements 
for importing sheep and goats. The World Trade Organization principles 
of ``national treatment'' and ``transparency'' state that regulations 
shall be applied without discrimination between domestic and imported 
consignments, and that countries shall make available to trading 
partners the rationale of their requirements. Our current regulations 
for importing sheep and goats use equivalency with the Voluntary 
Program to qualify certain animals for import (see 9 CFR 93.435), and 
we wish to ensure consistency between our import requirements and our 
interstate movement requirements.
    We believe the interstate movement restrictions and the definition 
of ``flock plan'' in part 79 provide a good model for how an infected 
or source flock may be effectively quarantined and managed until 
release from quarantine is justified. One possible approach to 
controlling the intrastate contact risks described above would be to 
amend part 79 to prohibit or restrict movement of animals from a State 
unless the State quarantines infected and source flocks in a manner 
that is equivalent to the methods employed by part 79. However, 
commenters may well suggest other approaches to revising part 79 to 
address the risks of intrastate movements from infected and source 
flocks.
    In particular, we ask commenters to address the following areas 
that apply to possible State quarantine standards, the alignment of 
Federal interstate movement restrictions with State standards, and 
Voluntary Program standards:

     Should APHIS further restrict interstate movement of 
animals from States that do not consider scrapie a reportable 
disease or do not quarantine infected flocks or source flocks? If 
so, should restrictions focus on high-risk animals or on broader 
classes of animals? (A high-risk animal is defined in 9 CFR 79.1. In 
short, a high-risk animal is: (1) An animal that is the progeny of a 
scrapie-positive dam; (2) an animal born in the same flock during 
the same lambing season as progeny of a scrapie-positive dam, with 
certain exceptions outlined in the definition; or (3) an animal born 
during the same lambing season as a scrapie-positive ewe or ram in a 
source flock or trace flock.)
     Currently, part 79 does not restrict interstate 
movement of high-risk animals from flocks that are not infected 
flocks or are not source flocks. Should APHIS restrict such 
movements, and if so, how?
     Should APHIS define how a State must conduct a 
quarantine in order to avoid further restrictions on interstate 
movement of animals from that State? If so, how should APHIS 
describe the necessary quarantine conditions (e.g., imposition of 
the quarantine; movement of animals into and from quarantined 
flocks; duration of the quarantine; identification requirements for 
quarantined animals, development and use of a flock plan; procedures 
for release from quarantine and follow-up monitoring)?
     Should any of the definitions in the interstate 
movement regulations in part 79 or the Voluntary Program in part 54 
be revised to better address this problem (e.g., the definitions of 
source flock, trace flock, and high-risk animal)?
     Should there be additional permit or official 
identification requirements for the interstate movement of any 
classes of sheep and goats to allow for a more effective national 
program for surveillance for scrapie and traceback of scrapie-
positive animals?
     Currently APHIS makes the following information 
available on its World Wide Web

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site: The identity of scrapie infected flocks and source flocks 
designated under part 79, and the identity and certification status 
of flocks participating in the Voluntary Program. Should APHIS 
continue to provide this information on the Web?
     To assess the impacts of options regarding the 
interstate movement of sheep and goats, baseline estimates of costs 
and benefits are needed. What are the costs and benefits of the 
current system of part 79, State quarantine standards, and the 
Voluntary Program? For example, what costs are involved in complying 
with State quarantine programs and how large are these costs? 
Similarly, what are the costs to a flock owner who participates in 
the Voluntary Program?

    We invite comments on these topics. We also welcome ideas as to 
different approaches we might take to improve our scrapie programs. In 
responding to the questions posed in this notice, commenters are urged 
to include economic reasons and data supporting their positions.
    Whenever possible, please refer to specific terms, definitions, or 
procedures contained in the current regulations in 9 CFR parts 54 and 
79, and in the program standards UM&R (available at http://
www.aphis.usda.gov/vs/scrapie/umr). A hard-copy of the program 
standards UM&R may be obtained by contacting the individual listed 
under FOR FURTHER INFORMATION CONTACT. These resources should provide a 
common context for discussing suggested changes. You may also wish to 
refer to the Scrapie Flock Status Report on the APHIS Web, which lists 
the certification status of flocks in the Voluntary Program and 
identifies known infected and source flocks nationwide. This report is 
at http://www.aphis.usda.gov/vs/scrapie/status.html.

    Authority: 21 U.S.C. 111-114, 114a, 115, 117, 120, 121, 123-126, 
134a-134h; 7 CFR 2.22, 2.80, and 371.2(d).

    Done in Washington, DC, this 21st day of January 1998.
Thomas E. Walton,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-1810 Filed 1-21-98; 4:40 pm]
BILLING CODE 3410-34-M