Federal Register / Vol. 62, No. 238 / Thursday, December 11, 1997 / Proposed Rules 65237

fluoroscopy.’’ As a concept for

discussion, fluoroscopic systems

designed for interventional radiology

might be defined as systems that permit

the beam axis to be positioned at an

angle relative to the normal to the table

top. Systems in which the x-ray beam

direction is fixed with respect to the

plane of the tabletop, such as

conventional radiographic/ fluoroscopic

systems, would not be included in this

definition.

5. Amendment to require improved xray field limitation (21 CFR

1020.32(b)(2)(v)). This proposal would

require improved limitation of the x-ray

field for fluoroscopic equipment to

match the actual area of the image

receptor being used for image capture,

thereby reducing the amount of nonuseful beam striking the patient.

6. Amendment to clarify the

requirements for the minimum sourceskin distance for small, mobile, or

portable mini C-arm systems

(§ 1020.32(g)). This amendment would

address numerous requested and

granted variances for fluoroscopic

systems that have limited source-image

receptor distances. The amendment

would specify the conditions under

which a shorter-than-standard sourceskin distance is permitted and would

obviate the need for continued variances

from the standard.

7. Amendment to require indication

of cumulative exposure time on

fluoroscopic systems (§ 1020.32(h)). The

proposed amendment would require the

means to indicate the cumulative time

of fluoroscopic irradiation of a patient

during an examination or procedure.

8. Amendment to require provision of

‘‘last-image-hold’’ feature on

fluoroscopic systems (§ 1020.32(j)). This

amendment would require that all

fluoroscopic x-ray systems be provided

with a means to continuously display

the last image acquired following

termination of any exposure period.

9. Amendment to require indication

of air kerma rate and cumulative air

kerma on fluoroscopic systems

(§ 1020.32(k)). The proposed

amendment would require the means to

display to the fluoroscopist at the

fluoroscopist’s working position the

cumulative air kerma and the air kerma

rate (air kerma per unit time) at which

air kerma accrues during irradiation of

a patient in an examination or

procedure.

III. Electronic Access

The summary of concepts for

amendments entitled ‘‘Concepts for

Proposed Amendments to the

Performance Standard for Diagnostic Xray Systems, August 1, 1997,’’ may be

accessed at the CDRH Home Page on the

World Wide Web. It is available on the

Topic Index page at: http://

www.fda.gov/cdrh/topindx under

‘‘Fluoroscopy’’. A text-only version of

the CDRH site is also available from a

computer or VT–100 compatible

terminal by dialing 800–222–0185

(terminal settings are 8/1/N). Once the

modem answers, press Enter several

times and then select menu choice 1:

FDA BULLETIN BOARD SERVICE.

From there, follow instructions for

logging in, and at the BBS TOPICS

PAGE, arrow down to the FDA Home

Page (do not select the first CDRH

entry). Then select Medical Devices and

Radiological Health. From there, select

CENTER FOR DEVICES AND

RADIOLOGICAL HEALTH for general

information, or arrow down for specific

topics.

The document may also be obtained

by fax by calling the CDRH Facts-OnDemand (FOD) system at 800–899–0381

or 301–827–0111 from a touch-tone

telephone. At the first voice prompt

press 1 to access DSMA Facts, at the

second voice prompt press 2, and then

enter the document number 591

followed by the pound sign (#). Then

follow the remaining voice prompts to

complete your request.

A summary of the TEPRSSC April 8

through 9, 1997, meeting is available on

the CDRH Home Page at the same

address given above for the concepts for

amendments document.

IV. Comments

Interested persons may, on or before

March 11, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposed amendment. Two copies of

any comments are to be submitted,

except that individuals may submit one

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 Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

Interested persons also are invited to

participate in the development of

proposed amendments by submitting

written data, views, or arguments

concerning the subject matter of the

amendments, or related topics suggested

for inclusion in the amendments. In

addition to general comments and

recommendations, respondents are

encouraged to include suggested text for

provisions of the proposed amendments

that reflect their recommended

performance requirements. A statement

of rationale should accompany any such

proposed text. When a determination is

made on the content of the proposed

amendments, they will be published as

notices of proposed rulemaking with

opportunity given for public comment.

Information and comments are

specifically invited on the following

topics:

1. For concepts 4 through 9 in section

II of this document, recommendation for

whether the amendments should be

limited only to equipment designed for

interventional procedures or for all

fluoroscopic systems. If only for

interventional systems, how should

‘‘interventional fluoroscopic systems’’

be defined?

2. The desirability and technical

feasibility of amendments of the type

described in section II of this document.

3. Recommended performance

requirements to be included in the

proposed amendments, including

attendant methods and conditions of

measurement.

4. Suggestions and supporting data for

other amendments to the performance

standard for radiographic or

fluoroscopic equipment, including

moving towards more outcome-based

performance standards, which may be

needed to provide for adequate

radiation safety.

5. The possible environmental impact

of this action, including factors such as

radiation exposure reduction or

prevention and economic consequences

in relation to expected benefits (costbenefit relationship), and the

anticipated costs of providing such

features or meeting the requirements.

6. Any additional terms or definitions

that are needed to better specify the

intent or meaning of the regulations as

they apply to the equipment.

This ANPRM is issued under 21

U.S.C. 321 and under the authority of

the Commissioner of Food and Drugs.

Dated: October 29, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32462 Filed 12–10–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

50 CFR Part 17

RIN 1018–AE45

Endangered and Threatened Wildlife

and Plants; Proposed Revision of

Special Regulations for the Gray Wolf

AGENCY: Fish and Wildlife Service,

Interior.
65238 Federal Register / Vol. 62, No. 238 / Thursday, December 11, 1997 / Proposed Rules

ACTION: Proposed rule.

SUMMARY: On November 22, 1994, the

U.S. Fish and Wildlife Service

published special rules to establish

nonessential experimental populations

of gray wolves (Canis lupus) in

Yellowstone National Park and central

Idaho. The nonessential experimental

population areas include all of

Wyoming, most of Idaho, and much of

central and southern Montana. A close

reading of the special regulations

indicates that, unintentionally, the

language reads as though wolf control

measures apply only outside of the

experimental population area. This

proposed revision is intended to amend

language in the special regulations so

that it clearly applies within the

Yellowstone nonessential experimental

population area and the central Idaho

nonessential experimental population

area. This proposed change will not

affect any of the assumptions and earlier

analysis made in the environmental

impact statement or other portions of

the special rules.

DATES: Comments must be received by

January 12, 1998.

ADDRESSES: Comments and materials

concerning this proposal should be sent

to the Gray Wolf Recovery Program, U.S.

Fish and Wildlife Service, 100 North

Park, Suite 320, Helena, Montana 59601.

Comments and materials received will

be available for public inspection, by

appointment, during normal business

hours at the above address.

FOR FURTHER INFORMATION CONTACT: Mr.

Edward E. Bangs, Wolf Recovery

Coordinator, at the above address, or

telephone (406) 449–5202, extension

204.

SUPPLEMENTARY INFORMATION:

Background

1. Legal: The Endangered Species Act

Amendments of 1982, Public Law 97–

304, made significant changes to the

Endangered Species Act (Act) of 1973,

as amended (16 U.S.C. 1531 et seq.),

including the creation of section 10(j)

which provides for the designation of

populations as ‘‘experimental.’’ It was

under this provision of the Act that on

November 22, 1994, the Service by

special rule established two areas for

nonessential experimental populations

of gray wolves (59 FR 60252 and 60266;

50 CFR 17.84(i)). One area was the

Yellowstone National Park experimental

population area which included all of

Wyoming, and parts of Montana, and

Idaho. The other area, called the central

Idaho experimental population area,

included much of Idaho and parts of

southwestern Montana. These rules

allowed the Service and other

cooperating agencies to manage wolf

recovery so that conflicts with people

were minimized. Under certain

circumstances the rules allowed for

wolves to be captured, relocated, held in

captivity, or killed. Subparts A, B, and

C 50 CFR 17.84 (i)(7)(iii) addressed the

management of reintroduced wolves

that traveled outside the experimental

areas or wolves of unknown status

outside the experimental population.

Subpart D in 50 CFR 17.84 (i)(7)(iii) D,

addressed the management of wolves

and wolf-like canids of unknown but

questionable status. Examples given

under 50 CFR 17.84 (I)(7)(iii) D include

wolves or wolf-like canids that

exhibited behavioral or physical

evidence of hybridization with other

canids, or wolf-like canids that may

have been raised or held in captivity

other than as part of a Service approved

wolf recovery program. The rule in 50

CFR 17.84 (i)(7)(iii) is currently worded

as follows:

All wolves found in the wild within

the boundaries of this paragraph (50

CFR 17.84 (i)(7)) after the first releases

will be considered nonessential

experimental animals. In the

conterminous United States, a wolf that

is outside an experimental area (as

defined in 50 CFR 17.84 (i)(7) of this

section) would be considered as

endangered (or threatened if in

Minnesota) unless it is marked or

otherwise known to be an experimental

animal; such a wolf may be captured for

examination and genetic testing by the

Service or Service-designated agency.

Disposition of the captured animal may

take any of the following courses:

(A) If the animal was not involved in

conflicts with humans and is

determined to be an experimental wolf,

it will be returned to the reintroduction

area.

(B) If the animal is determined likely

to be an experimental wolf and was

involved in conflicts with humans as

identified in the management plan for

the closest experimental area, it may be

relocated, placed in captivity, or killed.

(C) If the animal is determined not

likely to be an experimental animal, it

will be managed according to any

Service-approved plans for that area or

will be marked and released near its

point of capture.

(D) If the animal is determined not

likely to be a wild gray wolf or if the

Service or agencies designated by the

Service determine the animal shows

physical or behavioral evidence of

hybridization with other canids, such as

domestic dogs or coyotes, or of being an

animal raised in captivity, it will be

returned to captivity or killed.

The rule in 50 CFR 17.84(i)(7)(iii) was

intended to allow the Service, or

agencies designated by the Service,

management flexibility should

experimental wolves travel outside the

experimental population areas, and the

ability to (1) manage wolves of

unknown origin, (2) manage wolves that

exhibit abnormal behavior or physical

characteristics (indicative of

hybridization with other canids), and (3)

manage canids suspected of being raised

in captivity and released to the wild

independently of the Service wolf

recovery program. Furthermore, subpart

D was intended to allow for

management of those rare instances

where an individual wild wolf may

exhibit abnormal behavior that is not

conducive to the recovery and

conservation of wild gray wolf

populations in the northern Rocky

Mountains of Montana, Idaho, and

Wyoming. The section was intended to

enhance the survival and reproductive

potential of wild wolves and to remove

canids that could have a negative

impact on the survival and reproductive

potential of wild wolves.

Through an unintentional oversight in

the wording in 50 CFR 17.84 (i)(7)(iii)

subpart D appears to apply only to

activities conducted outside the

experimental population area. This

revision is being proposed to correct

that oversight and clarify that

management of wild wolves and wolflike canids that exhibit abnormal

behavior, wolf hybrids, or wolves that

may have been raised in captivity, also

applies within each experimental area.

2. Biological: This proposed revision

of the special regulations is intended to

clarify that the management flexibility

addressed by 50 CFR 17.84 (i)(7)(iii)

subpart D applies to wolves of

questionable status or wolf-like canids

within the nonessential experimental

population areas. As currently written

the special regulations could be

interpreted to imply that wolf hybrids or

captive wolves that were not part of a

Service-approved recovery program but

that escaped or were released to the

wild within the experimental area,

would be managed in a manner

identical to wild wolves within the

experimental population area. Wolves

or wolf-like canids that are raised in

captivity and released in the wild do not

behave like wild wolves. They often

associate with people or domestic

livestock, raising concerns about human

safety and depredations on domestic

animals. These types of canids also

often cause problems by attacking

domestic animals because they usually

are not able to survive entirely in the

wild. While they have some of the
Federal Register / Vol. 62, No. 238 / Thursday, December 11, 1997 / Proposed Rules 65239

predatory instincts of wild canids, they

are most comfortable around people.

They are likely to be dependent on

humans for food and this increases the

probability that they may attack

domestic animals since domestic

animals are the most common types of

animals near people. The tolerance of

captive raised and released canids for

people also contributes to the

perception that human safety may be in

danger from wild wolves. There are

numerous documented instances of

domesticated wolves and wolf hybrids

attacking and killing people. Although

unlikely, captive wolves or wolf hybrids

associating with wild wolves could

teach young wolves or any hybrid

offspring these undesirable traits. For

these reasons wolves exhibiting the

characteristics described above do not

contribute to the recovery of wild gray

wolf populations in the northern Rocky

Mountains.

When local residents believe wild

wolves behave like captive wolves or

wolf hybrids, public tolerance for wild

wolves is likely reduced. This can lead

to illegal killing of wolves. It was not

the intent of the wolf recovery program

to protect or manage captive wolves or

wolf hybrids that were not part of a

Service approved recovery program.

Those types of canids will not

contribute to the conservation and

recovery of wild gray wolves. The

Service intends to manage such canids

when necessary, to resolve potential

conflicts with humans and to minimize

the likelihood that undesirable genetic

or behavioral characteristics could be

passed on by such animals to wild

wolves within the experimental

population areas.

Captive wolves that have not been

specifically raised for release into the

wild, or wolf hybrids, can also carry

diseases or parasites that are common in

domestic dogs. If released into the wild,

such animals can transmit those

diseases or parasites to wild gray wolves

as well as other wildlife species. Current

DNA and other types of testing can not

reliably distinguish wild wolves from

wolves raised in captivity or from wolf

hybrids. Because captive wolves and

wolf hybrids may look identical to wild

wolves, they can often only be reliably

distinguished from wild wolves by their

behavior in the wild. Their presence can

often confuse the public about what

behavior to expect from wild wolves,

reduce local human tolerance of wild

wolves and lead to an increase in

human related wolf mortality. Local

tolerance of wolves is important for wolf

recovery and conservation since a

majority of wolf mortality in Montana is

caused by humans.

The presence and management of

wolves or wolf-like canids that are not

part of an approved recovery program

may result in substantial expense and

thereby compete for limited gray wolf

recovery program resources, particularly

if their management requires the same

level of effort as that afforded to wild

wolves. Because wolf hybrids and

captive wolves released into the wild

can demand considerable management

time and attention at the expense of

wild wolf conservation, prompt control

of these animals is essential. The

selective removal from the wild of

captive raised and released wolves, wolf

hybrids, and/or wolf-like canids

exhibiting behavior considered

abnormal for wild gray wolves furthers

the conservation and recovery of the

gray wolf by minimizing the probability

of unresolved conflicts with humans.

Wild wolves were taken from the wild

in remote areas of Canada and

reintroduced in January of 1995 and

1996 to the Yellowstone and central

Idaho experimental population areas

and have adapted much better than

predicted. As expected, they continue to

behave like wild wolves. If current

trends continue, it is unlikely that

further reintroductions in the

experimental population areas will be

required. All the wolves that were

reintroduced were radio-collared and

monitored by means of radio-telemetry,

and a number these wolves have

successfully reproduced in the wild.

Current plans do not call for all of the

pups to be individually captured and

radio-collared. As the population grows,

there will be an increasing number of

wolves that have not been marked and

it will not be possible to determine

where most of these wolves originated.

It is also estimated that there may be up

to 300,000 captive wolves and wolf/dog

hybrids (which in many cases are

physically and genetically

indistinguishable from wild wolves) in

North America. Therefore, the special

regulations for establishment of

nonessential experimental populations

of gray wolves need to clearly address

the manner in which wolves, whose

origin is unknown or wolves that

exhibit abnormal behavior will be

managed in the wild when conflicts

develop.

In several areas of the northern Rocky

Mountains, wolf-like canids have been

identified through their behavior or

physical characteristics as released or

escaped wolves that were not part of

Service approved programs or wolf

hybrids of captive origin. Such animals

usually do not survive in the wild long

enough to successfully reproduce and

raise young. In several instances these

animals have been removed from the

wild because they have become a

nuisance or potential human or

domestic animal safety concerns arose.

All wolves, including wild ones, are

individuals, and some wild wolves may

exhibit abnormal or other behavior that

is inconsistent with the continued

survival, reproduction, and recovery of

wild gray wolf populations. For

example, some individual wolves may

attack livestock or domestic pets. The

Service recognizes that such individuals

must be managed (through removal to

another location or placement in

captivity, or lethal means) to minimize

chronic conflicts with domestic animals

if local people are expected to continue

to tolerate the presence of a resident

wolf population. The Service has

determined that removal of such

individuals furthers the conservation

and recovery of the wild gray wolf

population. In a similar although

extremely rare situation, individual

wolves may on occasion exhibit

behaviors that are uncharacteristic of

those normally observed in wild wolves.

Although highly unlikely, it is possible

that a wild wolf may demonstrate

physical or behavioral evidence of

hybridization with other canids, such as

domestic dogs or coyotes. It also is

possible that an individual wolf may

become a nuisance, or pose a potential

risk to people or livestock because of

habituation to food sources, human and

domestic animal companionship, or

other factors. The Service intended that

50 CFR 17.84(i)(7)(iii) subpart D allow

for the management and/or removal of

all such individuals within the

nonessential experimental population

areas for the benefit and conservation of

the wild gray wolf populations.

Location of the Experimental

Population

The Yellowstone experimental

population area includes the State of

Wyoming, that portion of Idaho east of

Interstate Highway 15, and the State of

Montana east of Interstate Highway 15

and south of the Missouri River east of

Great Falls, Montana, to the Montana/

North Dakota border.

The central Idaho experimental

population area includes that portion of

Idaho west of Interstate 15 and south of

Interstate 90, and that portion of

Montana south of Interstate 90, Highway

93 and 12 near Missoula, Montana, and

west of Interstate 15.

Management

Management of wild wolves would

not change from that established by the

special rules, except in those rare

instances when a wild wolf exhibits
65240 Federal Register / Vol. 62, No. 238 / Thursday, December 11, 1997 / Proposed Rules

abnormal behavior. This proposed

revision would apply 50 CFR

17.84(i)(7)(iii) subpart D within the

experimental population areas, which

would further the conservation and

recovery of wild gray wolves in the

northern Rocky Mountains of the United

States. The rule in 50 CFR 17.8e(i)(7)(iii)

would apply to all wolves and wolf-like

canids found within and adjacent to the

experimental population areas in

Montana, Idaho, and Wyoming.

National Environmental Policy Act

This proposed revision does not

significantly change the special

regulations or the effect of the special

regulations on the human environment.

An environmental action statement has

been prepared that determined the

proposed revision is a categorical

exclusion as provided by 516 DM 2,

Appendix 1 and 516 DM 6, Appendix 1.

No further NEPA documentation will

therefore be made.

Required Determinations

This is not a significant rule subject

to Office of Management and Budget

review under Executive Order 12866.

The Department of the Interior certifies

that this document will not have a

significant economic effect on a

substantial number of small entities

under the Regulatory Flexibility Act (5

U.S.C. 601 et seq.). The proposed

revision is purely technical in nature

and intended to correct a technical

oversight in the rule originally adopted

in 1994; it will not increase or alter the

effects brought by the original rule. The

Service has determined and certifies

pursuant to the Unfunded Mandates

Act, 2 U.S.C. 1502 et seq., that this

rulemaking will not impose a cost of

$100 million or more in any given year

on local or State governments or private

entities. The Department has

determined that this proposed

regulation meets the applicable

standards provided in sections 3(a) and

3(b)(2) of Executive order 12988.

Author: The principle author of this

rule is Edward E. Bangs (see ADDRESSES

section).

List of Subjects in 50 CFR Part 17

Endangered and threatened species,

Exports, Imports, Reporting and record

keeping requirements, Transportation.

Proposed Regulation Promulgation

Accordingly, the Service hereby

proposes to amend part 17, subchapter

B of chapter I, title 50 of the Code of

Federal Regulations, as set forth below:

PART 17—[AMENDED]

1. The authority citation for Part 17

continues to read as follows:

Authority: 16 U.S.C. 1361–1407; 16 U.S.C.

1531–1544; 16 U.S.C. 4201–4245; Public Law

No. 99–625, 100 Statute 3500; unless

otherwise noted.

2. Revise § 17.84(i)(7)(iii) to read as

follows:

§ 17.84 Special rules—vertebrates.

* * * * *

(i) * * *

(7) * * *

(iii) All wolves found in the wild

within the boundaries of this paragraph

(i)(7) after the first releases will be

considered nonessential experimental

animals. In the conterminous United

States, a wolf that is outside an

experimental area (as defined in

paragraph (i)(7) of this section) would

be considered as endangered (or

threatened if in Minnesota) unless it is

marked or otherwise known to be an

experimental animal. Wolves in the

wild may be selectively captured,

removed, or killed for examination and

genetic testing by the Service or Service

designated agency. Disposition of such

wolves outside the experimental areas

and in the case of subpart D, those both

outside of and within the experimental

population areas, may take any of the

following courses:

(A) If the animal was not involved in

conflicts with humans and is

determined likely to be a wild

experimental wolf, it will be returned to

the reintroduction area.

(B) If the animal is determined likely

to be a wild experimental wolf and was

involved in conflicts with humans as

identified in the management plan for

the closest experimental area, it may be

relocated, placed in captivity or killed.

(C) If the animal is determined not

likely to be a wild experimental wolf, it

will be managed according to any

Service-approved plans for that area or

will be marked and released near its

point of capture.

(D) If the animal is determined not

likely to be a wild gray wolf or if the

Service or agencies designated by the

Service determine that any wild wolf

exhibits abnormal behavior or that any

wolf or wolf-like canid shows physical

or behavioral evidence of hybridization

with other canids, such as domestic

dogs or coyotes, or of being an animal

raised in captivity other than as part of

a Service-approved wolf recovery

program, it will be killed, or placed in

captivity.

* * * * *

Dated: November 13, 1997.

Donald J. Barry,

Acting Assistant Secretary for Fish and

Wildlife and Parks.

[FR Doc. 97–32440 Filed 12–8–97; 3:42 pm]

BILLING CODE 4310–55–P