43444 Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Rules and Regulations

DEPARTMENT OF INTERIOR

Fish and Wildlife Service

50 CFR Part 20

RIN 1018-AE09

Migratory Bird Hunting; Temporary

Conditional Approval of Tungsten-Iron

Shot as Nontoxic for the 1997–98

Season

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Final rule.

SUMMARY: The U.S. Fish and Wildlife

Service (Service) amends Section

20.21(j) and temporarily approves

tungsten-iron shot as nontoxic for the

1997–98 migratory bird hunting season.

The toxicological report and extensive

literature search and analysis suggests

that tungsten and tungsten-iron are

nontoxic under conditions for the

proposed shot configuration. Analysis of

the toxicity study reveals no adverse

effects over a 30-day period when

dosing mallards with 8 BB-size

tungsten-iron shot.

EFFECTIVE DATE: September 1, 1997.

FOR FURTHER INFORMATION CONTACT: Paul

R. Schmidt, Chief, or Carol Anderson,

Wildlife Biologist, Office of Migratory

Bird Management (MBMO), (703) 358–

1714.

SUPPLEMENTARY INFORMATION: Since the

mid-1970s, the Service has sought to

identify shot that, when spent, does not

pose a significant toxic hazard to

migratory birds and other wildlife.

Currently, steel shot and bismuth-tin

shot are approved by the Service as

nontoxic. The Service believes approval

for other suitable candidate shot

materials as nontoxic is feasible.

Compliance with the use of nontoxic

shot is increasing over the last few

years. The Service believes that this

level of compliance will continue to

increase with the availability and

approval of other nontoxic shot types.

The Service is eager to consider these

other materials for approval as nontoxic

shot.

Federal Cartridge Company’s (Anoka,

MN) candidate shot is made from

sintering tungsten and iron, which

forms a two-phase alloy. Shot made

from this material has a density of

approximately 10.3 gm/cc, or 94 percent

of the density of lead. The tested shot

will contain nominally 55 percent

tungsten and 45 percent iron, by weight;

whereas, the marketed shot will contain

nominally 40 percent tungsten and 60

percent iron, by weight. The pellet will

have sufficient iron to attract a magnet.

The Service, in consultation with the

U.S. Geological Service, Biological

Resources Division, considers the higher

tungsten ratio of the tested shot more

potentially toxic and that the lower ratio

of the marketed shot poses significantly

less risk.

Federal’s application includes a

description of the new tungsten-iron

shot, a toxicological report, and results

of a 30-day dosing study (Test 1) to

assess the toxicity of this shot in gamefarm mallards as outlined in 50 CFR

20.134(c)(2). The toxicological report

incorporates toxicity information (a

synopsis of acute and chronic toxicity

data for birds, acute effects on

mammals, potential for environmental

concern, toxicity to aquatic and

terrestrial invertebrates, amphibians and

reptiles), and information on

environmental fate and transport (shot

alteration, environmental half-life, and

environmental concentration). The

toxicity study is a 30-day dosing test to

determine if the candidate shot poses

any deleterious effects to game-farm

mallards.

Toxicity Information: There is

considerable difference in the toxicity of

soluble and insoluble compounds of

tungsten and iron. Elemental tungsten

and iron are virtually insoluble and,

therefore, are expected to be nontoxic.

After completion of the literature

review, there appears to be no basis for

concern of toxicity to wildlife for the

candidate shot material (metallic

tungsten and iron) via ingestion by fish,

birds, or mammals (Bursian et al. 1996;

Gigiena 1983; Patty 1981; Industrial

Medicine 1946; Karantassis 1924).

Environmental Fate and Transport:

Tungsten is insoluble in water and,

therefore, not mobile in hypergenic

environments. Tungsten is very stable

with acids and does not easily complex.

Preferential uptake by plants in acid soil

suggests uptake of tungsten in the

anionic form associated with tungsten

minerals rather than elemental tungsten

(Kabata-Peddias 1984).

Environmental Concentration: The

expected environmental concentration

(EEC) is defined as the concentration of

a chemical in a particular

environmental compartment that is

based on an estimate or modeling

simulation of use, disposal, transport,

and fate of a chemical. Calculation of

the EEC for a terrestrial ecosystem is on

69,000 shot per hectare (Pain 1990),

assuming complete erosion of material

in 5 cm of soil. The EEC for tungsten in

soil is 32.9 mg/kg of shot material left

in the soil after the initial degradation

of the shot. This calculated amount is

based on shot composed of 62.9 percent

tungsten-iron alloy, 11.87 percent

tungsten, and 25.31 percent iron.

Adverse effects on biota are not

expected to occur for shot components,

given the Hazard Quotients (HQs).

Calculation of the expected

environmental concentration (EEC) for

an aquatic ecosystem assumes complete

erosion of the shot in one cubic foot of

water. The EEC in water for tungsten

was 10.5 mg/L left in the water after the

initial degredation of the shot. This

calculated amount is based on shot

composed of 62.9 percent tungsten-iron

alloy, 11.87 percent tungsten, and 25.31

percent iron. Given these HQs, adverse

effects on biota are not expected to

occur for shot components.

An extensive literature search and

review provides information on the

toxicity of elemental tungsten to

waterfowl and other birds. Ringelman et

al.’s (1993) investigation of the effects of

ingested tungsten-bismuth-tin (TBT)

shot on captive mallards found no acute

toxicity. Orally dosing 28-week old

game-farm mallards with 12 to 17

pellets (1.03g) of TBT shot revealed no

evidence of intoxication over a period of

32 days. No birds died during the trial.

Gross lesions were not observed during

the postmortem examination.

Histopathological examination did not

reveal any evidence of toxicity or tissue

damage. Tungsten was not detectable in

kidney or liver samples. The authors

concluded that TBT shot presents

virtually no potential for acute

intoxication in mallards.

A study by Kraabel et al. (1996)

assessed the effects of embedded

tungsten-bismuth-tin shot on mallards.

The authors’ conclusion was that TBT is

not acutely toxic when implanted in

mallard muscle tissue. Inflammatory

reactions to TBT shot were localized,

and had no detectable systemic effects

on mallard health.

Nell (1981) fed laying hens 0.4 or 1g/

kg tungsten in a commercial mash for

five months to assess the reproductive

performance. Weekly egg production

was normal and hatchability of fertile

eggs was not affected.

Large doses of tungsten given to

chickens either through injection or by

feeding saw an increase in tissue

concentration of tungsten and a

decreased tissue concentration of

molybdenum (Nell 1981). The loss rate

of tungsten from the liver occurred in an

exponential manner with a half-life of

27 hours. The alterations in

molybdenum metabolism seem to

identify with tungsten and not of

molybdenum deficiency. Death due to

tungsten occurred when tissue

concentrations were increased to 25μg/

g liver. At this concentration, the
Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Rules and Regulations 43445

activity of xanthine dehydrogenase was

zero.

In Federal’s dosing study, eight male

and 8 female adult mallards were given

8 #4 steel shot, 8 #4 lead shot, or 8 BB’s

of tungsten-iron and observed over a 30-

day period. An additional 8 males and

8 females were given no shot. All

tungsten-iron birds survived the test

with a slight increase in body weight.

There were no changes in hematocrit,

hemoglobin concentration, and ALAD

activity, as well as 25 plasma chemistry

parameters. Five of the 16 tungsten-iron

birds had a mild hepatocellular biliary

stasis, but the authors felt this was not

remarkable. No other histopathological

lesions were found. There was some

absorption of tungsten in the femur,

kidney, and liver, with some effect on

the bile. In general,however, no adverse

effects were seen when mallards were

given 8 BB-size tungsten-iron shot and

monitored over a 30-day period. Fifty

percent of the lead-dosed birds (5 males

and 3 females) died during the 30-day

test while there were no mortalities in

the other groups. Lead-dosed birds were

the only ones to display green excreta,

lethargy, and ataxia. Alteration of body

weights was not significant in any of the

treatments, although lead-dosed birds

which died during the trial lost an

average of 30 percent of their body

weight. Hematocrit, hemoglobin

concentrations, and ALAD activity were

significantly depressed at day 15 in the

lead-dose females, while lead-dose

males had significantly depressed

hematocrit and hemoglobin

concentration in comparison to the

other three groups. There were no

significant differences in these wholeblood parameters at day 30.

As a result of the toxicological report

and toxicity test the Service concludes

that tungsten-iron shot, nominally 40–

55 percent tungsten and 60–45 percent

iron, by weight with <1 percent residual

lead, does not impose significant danger

to migratory birds and other wildlife

and their habitats. The Service has some

concern that the absorption of tungsten

into the femur, kidney, and liver may

have some potential effect on the

spectacled eider (Somateria fischeri), a

species already subject to adverse

weather, predation, and lead poisoning

when waterfowl are harvested in its

Yukon-Kuskokwim Delta (Y-K Delta)

habitat in Alaska. Until the results of

reproductive/chronic toxicity tests,

which includes the assessment of

reproduction, fertility rates, and egg

hatchability (egg weight, shell thickness,

and content analysis) have been

completed and the Service has reviewed

the results, tungsten-iron shot cannot be

conditionally approved for the Y-K

Delta habitat in Alaska.

The first condition of final

unconditional approval is the

concurrent running of an adverse

condition test (Test 2) and a

reproductive/chronic toxicity test (Test

3) on game-farm mallards as outlined in

50 CFR 20.134 (c)(2) and in consultation

with the Service’s Office of Migratory

Bird Management and the U.S.

Geological Survey’s Division of

Biological Resources. This study

includes assessment of reproduction,

fertility rates, and egg hatchability (egg

weight, shell thickness, and content

analysis). The test requires the applicant

to demonstrate that tungsten-iron shot is

nontoxic to waterfowl and their

offspring.

The second condition of final

unconditional approval is testing for

residual lead levels. In the Federal

Register of August 18, 1995 (60 FR

43314), the Service indicated it would

establish a maximum level for residual

lead. The Service, in consultation with

the USGS—Division of Biological

Resources, determined the maximum

environmentally acceptable level of lead

in any nontoxic shot is trace amounts or

<1 percent and is incorporating this

requirement into this rule and will

incorporate it into any subsequent final

rule that may be promulgated. Federal

documented that the tungsten-iron shot

had no residual lead levels equal to or

exceeding 1 percent.

The third condition of final

unconditional approval involves

enforcement. In the August 18, 1995,

Federal Register (60 FR 43314), the

Service indicated that final

unconditional approval of any nontoxic

shot would be contingent upon the

development and availability of a

noninvasive field testing device. Several

noninvasive field testing devices are

under development to separate

tungsten-iron shot from lead shot.

Furthermore, tungsten-iron shot can be

drawn to a magnet as a simple field

detection method.

This rule amends 50 CFR 20.21(j) by

temporarily approving tungsten-iron

shot as nontoxic for the 1997–98

migratory bird hunting season

throughout the United States except for

the Y-K Delta habitat in Alaska. It is

based on the original request made to

the Service by Federal Cartridge

Company on August 20, 1996, the

toxicological report, and acute toxicity

study. Results of the toxicological report

and 30-day toxicity test undertaken for

Federal Cartridge Company indicate the

apparent absence of any deleterious

effects of tungsten-iron shot when

ingested by captive-reared mallards or

to the ecosystem.

Public Comments and Responses

The January 31, 1997, proposed rule

published in the Federal Register (62

FR 4877) invited public comments from

interested parties. The closing date for

receipt of all comments was April 1,

1997. During this 60-day comment

period, the Service received five

comment letters. Of these comment

letters, three were from individuals and

two from industry organizations.

Individuals expressed support for the

temporary approval of tungsten-iron

shot. Individuals ‘‘. . . would love the

opportunity to try the new shot’’ and

believed that ‘‘. . . any nontoxic

alternative that approaches the

effectiveness of lead should be

explored.’’

The Bismuth Cartridge Company

(Bismuth) is concerned that the Service

should ensure that all applicants for

non-toxic shot approval are subject to

comparable requirements and

conditions. The Service does ensure that

any candidate nontoxic material will

comply with current regulations set

forth in 50 CFR 20.134 for nontoxic shot

approval. Applications for approval

must include a description of the

candidate shot, a toxicological report on

the candidate shot, and a 30-day dosing

test with mallards. As new information

becomes available, applications may be

revised to include this information,

which will assist the Service in

evaluating the candidate material.

Furthermore, Bismuth stated that

‘‘...no testing of reproductive tissues

(i.e., gonads) was conducted in

association with Federal’s 30-day

toxicity testing.’’ The current

regulations do not require that gonads

be chemically analyzed for metals in

Test 1. The Service notified Federal that

this would not be a requirement during

the Test 1 phase because Federal

demonstrated that there was existing

data on the effects of tungsten and iron

on the reproductive tissues in the

scientific literature. Once the shot is

conditionally approved, guidance for

further testing is provided to the

applicant. Following satisfactory

completion of Tests 1, 2, and 3, or their

equivalent, and publication of a

summary of these results in the Federal

Register for public comment, the

candidate material is concomitantly

proposed for inclusion in 50 CFR

20.21(j).

Bismuth is also concerned that

Federal is not being held to as strict a

requirement as they were during their

application process for approval of

bismuth-tin. Bismuth states that they
43446 Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Rules and Regulations

conducted additional assays to

demonstrate that bismuth-tin shot’s

residual lead levels were at levels well

below the <1 percent standard. Their

concern lies in the fact that the

proposed rule does not state that the

applicant will need to provide data

demonstrating the absence of any

carcinogenic materials in its shot. The

Service required the applicant to

demonstrate that the candidate shot

contains no significant trace levels of

lead or other toxic or carcinogenic

materials. The Service indicated in the

August 18, 1995, Federal Register, that

a maximum level of residual lead would

be established. The Service, in

consultation with the USGS—Division

of Biological Resources (formerly the

National Biological Service), determined

the maximum environmentally

acceptable level of lead in bismuth-tin

shot is trace amounts or <1 percent.

This requirement was incorporated in

the final rule approving bismuth-tin

shot. This same requirement applies to

tungsten-iron shot.

Winchester states ‘‘the shot sample

submitted for the acute toxicity portion

of the required testing was significantly

different from the shot that is being

marketed and requested for approval.’’

Winchester analyzed samples of shot

they obtained at retail and found that

the tungsten-iron alloy phases varied.

‘‘Since the application indicates that the

shot is heated to thermal equilibrium

and not chemical equilibrium, this is

not surprising.’’ Furthermore, two

different phases of intermetallic

compound (Fe2W and FeW) and pure

tungsten were also present in the

marketed shot. The Service requested

additional information from Federal

regarding the details of the

manufacturing process of the tungsteniron shot. Federal states the tungsteniron shot is sintered at 1520°C under a

tight time and temperature tolerance.

The Fe7W6 compound is formed at

thermal equilibrium, which takes into

account all energy factors, unlike

chemical equilibrium. The shot is then

quickly cooled to ambient temperatures

much like quenching steel. High cooling

rates of the tungsten-iron shot, in part

due to the small size of the tungsteniron shot, preclude the formation of

compounds other than Fe7W6. The

Fe7W6 that forms at the 1520°C sintering

temperature is cooled too quickly to

change to other compounds.

Transformation to other compounds is

sluggish; x-ray diffraction analysis

confirms the absence of the other

intermetallic compounds. The Toxicity

Test 1, and subsequent Toxicity Tests 2

and 3, will be conducted using

tungsten-iron shot representing a

‘‘worst-case’’ scenario, i.e., the shot

being tested has a higher concentration

of the Fe7W6 compound than the shot

Federal plans to manufacture for public

use.

Winchester also raised their concern

about the fact that the ‘‘soft’’ matrix of

this tungsten-iron shot is as hard or

harder than current gun barrels which

have been designed for steel shot. The

Service agrees that this should be a

concern for the consumer. Federal

recognized that the hardness of the

tungsten-iron shot would require a new

wad to protect shotgun bores from

scouring. Federal designed a wad made

of high-density polyethylene which

features three inner petals overlapped

by three outer petals so there are no

exposed wad slits to allow the shot to

contact the barrel or chokes. The wad’s

outer petals are designed to shear back

or off once it exits the barrel.

Additionally, tungsten-iron shot is not

recommended for use with older

shotguns or for fine double guns not

designed to handle steel. Federal

advises that these tungsten loads should

only be shot through barrels and chokes

approved for use with steel shot.

Furthermore, Winchester is concerned

that the payloads and/or pellet counts in

the marketed shot have generally not

been found to be effective, efficient

harvesters of game at anything but very

modest ranges. The primary

shortcoming is insufficient pattern

density to ensure the necessary number

of pellet strikes for consistent, clean

bagging of game. It is reasonable to

expect the possibility of a high crippling

rate for either of these very low pellet

count loads. Previous uses of low pellet

count, relatively high energy pellets

have generally not yielded satisfactory

results. Federal recognized that

tungsten-iron shot has different ballistic

properties than that of steel and

bismuth-tin shot. Consequently, they

conducted ballistic tests using ballistic

software modeling and test-firing the

tungsten shot. Their research indicated

that a relatively light payload with a

high velocity was the best alternative.

Tests show that the new loads shot tight

patterns like steel; offered ballistic

advantages of high velocity; had better

downrange energy than steel, bismuth,

or lead; and produced better penetration

than the other pellet materials. The

Service expects that crippling rates may

increase slightly with the advent of any

new nontoxic shot; however, continued

education and training of waterfowl

hunters will help keep crippling loss to

a minimum. The effectiveness of any

shot is a function of the shooter’s ability

to place the pellets on the bird, the

pellet’s energy at point-of-contact, and

the pellet’s ability to penetrate. Hunters

should test different loads with their

guns before hunting with any new shot

so that adjustments can be made to their

technique in order to reduce crippling

losses. Initial field testing in Canada has

shown that the tungsten-iron shot

performed exceptionally well.

References

A list of references is available and

will be provided upon request.

NEPA Consideration

In compliance with the requirements

of section 102(2)(C) of the National

Environmental Policy Act of 1969

(NEPA) (42 U.S.C. 4332(C)), and the

Council on Environmental Quality’s

regulation for implementing NEPA (40

CFR 1500–1508), the Service prepared

an Environmental Assessment (EA) in

December, 1996. This EA is available to

the public at the Office of Migratory

Bird Management, U.S. Fish and

Wildlife Service, ms 634—ARLSQ, 1849

C Street NW., Washington D.C. 20240.

Based on review and evaluation of the

information in the EA, the Service

determined the action to amend 50 CFR

20.21(j) to extend temporary conditional

approval of tungsten-iron shot as

nontoxic for 1997–98 and 1998–99

migratory bird hunting seasons would

not be a major Federal action that would

significantly affect the quality of the

human environment.

Endangered Species Act Considerations

Section 7 of the Endangered Species

Act (ESA) of 1972, as amended (16

U.S.C. 1531 et seq.), provides that, ‘‘The

Secretary shall review other programs

administered by him and utilize such

programs in furtherance of the purposes

of this Act’’ (and) shall ‘‘insure that any

action authorized, funded or carried out

... is not likely to jeopardize the

continued existence of any endangered

species or threatened species or result in

the destruction or adverse modification

of (critical) habitat ...’’ Pursuant to

section 7 of the ESA, MBMO sought

review and concurrence that this action

≥is not likely to adversely affect≥

threatened, endangered, proposed, and

category 1 species. Based on review and

evaluation of the toxicity testing and

available information, the Service

determined that no adverse impact on

endangered and threatened species

would result from the proposed action.

The results of this review may be

inspected by the public in, and will be

available to the public from, the Office

of Migratory Bird Management, U.S.

Fish and Wildlife Service, ms 634—
Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Rules and Regulations 43447

ARLSQ, 1849 C Street NW, Washington

D.C. 20240.

Regulatory Flexibility Act, Executive

Order 12866, and the Paperwork

Reduction Act

The Regulatory Flexibility Act of 1980

(5 U.S.C. 601 et seq.) requires the

preparation of flexibility analyses for

rules that will have a significant effect

on a substantial number of small

entities, which includes small

businesses, organizations or

governmental jurisdictions. The

economic impacts of annual hunting on

small business entities were analyzed in

detail and a Small Entity Flexibility

Analysis (Analysis), was issued by the

Service in 1995. The Analysis

documented the significant beneficial

economic effect on a substantial number

of small entities. The primary source of

information about hunter expenditures

for migratory game bird hunting is the

National Hunting and Fishing Survey,

which is conducted at 5-year intervals.

The Analysis utilized the 1991 National

Hunting and Fishing Survey and the

U.S. Department of Commerce’s County

Business Patterns from which it was

estimated that migratory bird hunters

would spend between $10 and $59

million at small businesses in 1995. The

approval of tungsten-iron as an

alternative shot to steel and bismuth-tin

will have a minor positive impact on

small businesses by allowing them to

sell a third nontoxic shot to the hunting

public. However, the overall effect to

hunting expenditures in general would

be minor. Therefore, the Service

determined this rule will have no effect

on small entities since the approved

shot merely will supplement nontoxic

shot already in commerce and available

throughout the retail and wholesale

distribution systems. The Service

anticipates no dislocation or other local

effects, with regard to hunters and

others. This rule was not subject to

Office of Management and Budget

(OMB) review under Executive Order

12866. The Service has examined this

regulation under the Paperwork

Reduction Act of 1995 and found it to

contain no information collection

requirements.

Unfunded Mandates Reform

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 government or

private entities.

Civil Justice Reform—Executive Order

12988

The Service, in promulgating this

rule, determines that these regulations

meet the applicable standards provided

in Sections 3(a) and 3(b)(2) of Executive

Order 12988.

Authorship

The primary author of this final rule

is Carol Anderson, Office of Migratory

Bird Management.

List of Subjects in 50 CFR Part 20

Exports, Hunting, Imports, Reporting

and recordkeeping requirements,

Transportation, Wildlife.

Accordingly, Part 20, Subchapter B,

Chapter 1 of Title 50 of the Code of

Federal Regulations is amended as

follows:

PART 20—[AMENDED]

1. The authority citation for Part 20

continues to read as follows:

Authority: 16 U.S.C. 703–712 and 16

U.S.C. 742 a—j.

2. Section 20.21 is amended by

revising paragraph (j), introductory text,

and adding paragraph (j)(2) to read as

follows:

§ 20.21 Hunting methods.

* * * * *

(j) While possessing shot (either in

shotshells or as loose shot for

muzzleloading) other than steel shot, or

bismuth-tin (97 parts bismuth: 3 parts

tin with <1 percent residual lead) shot,

or tungsten-iron (nominally 40 parts

tungsten: 60 parts iron with <1 percent

residual lead) shot or such shot

approved as nontoxic by the Director

pursuant to procedures set forth in

20.134, provided that:

(1) * * *

(2) Tungsten-iron shot (nominally 40

parts tungsten: 60 parts iron with <1

percent residual lead) is legal as

nontoxic shot for the 1997–98 migratory

bird hunting season, except for the

Yukon-Kuskokwim Delta habitat in

Alaska.

Dated: August 7, 1997.

Donald J. Barry,

Acting Assistant Secretary for Fish and

Wildlife and Parks.

[FR Doc. 97–21448 Filed 8–12–97; 8:45 am]

BILLING CODE 4310–55–F