Migratory Bird Hunting; Temporary and Conditional Approval of Tungsten-Matrix Shot as Nontoxic for the 1998-99 Season

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

50 CFR Part 20

RIN 1018-AE38

Migratory Bird Hunting; Temporary and Conditional Approval of

Tungsten-Matrix Shot as Nontoxic for the 1998-99 Season

AGENCY: Fish and Wildlife Service, Interior.

ACTION: Proposed rule.

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SUMMARY: The U.S. Fish and Wildlife Service (Service) proposes to amend

its regulations and grant temporary and conditional approval of

tungsten-matrix shot as nontoxic for the 1998-99 migratory bird hunting

season, except in the Yukon-Kuskokwim (Y-K) Delta, Alaska, while

reproductive/chronic toxicity testing is being completed. Tungsten-

matrix shot has been submitted for consideration as nontoxic by Kent

Cartridge Manufacturing Company, Ltd. (Kent), of Kearneysville, West

Virginia.

DATES: Comments on the proposed rule must be received no later than

November 18, 1998.

ADDRESSES: Copies of the draft EA are available by writing to the

Chief, Office of Migratory Bird Management (MBMO), U.S. Fish and

Wildlife Service, 1849 C Street, NW., ms 634-ARLSQ, Washington, D.C.

20240. Comments may also be forwarded to this same address. The public

may inspect comments during normal business hours in room 634,

Arlington Square Building, 4401 N. Fairfax Drive, Arlington, Virginia.

FOR FURTHER INFORMATION CONTACT: Robert J. Blohm, Acting Chief, or

James R. Kelley, Jr., 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 does not pose a significant toxic hazard to

migratory birds or other wildlife. Currently, only steel and bismuth-

tin shot are approved by the Service as nontoxic. On October 7, 1998

tungsten-iron (63 FR 54015) and tungsten-polymer (63 FR 54021) shot

were given temporary conditional approval for the 1998-99 hunting

season. 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.

The revised procedures for approving nontoxic shot (50 CFR 20.134)

consist of a three-tier process whereby existing information can

minimize the need for full testing of a candidate shot. However,

applicants still carry the burden of proving that the candidate shot is

nontoxic. By developing the new approval procedure, it was the

Service's intent to discontinue the practice of granting temporary

conditional approval to candidate shot material. However, the

application by Kent was initiated prior to implementation of the new

protocol. To date, scientific information presented in the application

suggests that tungsten-matrix is nontoxic under conditions for the

proposed shot configuration. Therefore, the Service has agreed to grant

temporary conditional approval for the 1998-99 hunting season.

Permanent approval will not be granted until further testing is

successfully completed; which is consistent with the previous nontoxic

shot approval process.

Kent's original candidate shot was fabricated from what is

described in their application as ``* * * a mixture of powdered metals

in a plastic matrix whose density is comparable to that of lead. All

component metals are present as elements, not compounds. Tungsten-

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matrix pellets have specific gravity of 9.8 g/cm3 and is composed of 88

percent tungsten, 4 percent nickel, 2 percent iron, 1 percent copper,

and 5 percent polymers by mass'' (63 FR 30044; June 2, 1998). After

consultation with the Service, Kent subsequently changed the

composition of their shot and removed nickel and copper. The new shot

material being considered has a density of 10.7 g/cm3 and is

composed of approximately 95.9 percent tungsten and 4.1 percent

polymers.

Kent Cartridge's updated application includes a description of the

reformulated tungsten-matrix (TM) shot, a toxicological report (Thomas

1997), and results of a 30-day dosing study of the toxicity of the

original formulation in game-farm mallards (Wildlife International,

Ltd. 1998). The toxicological report incorporates toxicity information

(a synopsis of acute and chronic toxicity data for mammals and birds,

potential for environmental concern, and toxicity to aquatic and

terrestrial invertebrates, amphibians and reptiles) and information on

environmental fate and transport. The toxicity study is a 30-day dosing

test to determine if the original candidate shot poses any deleterious

effects to game-farm mallards. This will meet the requirements for Tier

2, as described in 50 CFR 20.134(b)(3). Because the re-formulated shot

contains no new components, and in fact has had components removed

(nickel and copper), the Service believes that re-testing of the

reformulated shot in the form of a new 30-day dosing study is not

required.

Toxicity Information

There is considerable difference in the toxicity of soluble and

insoluble compounds of tungsten. Elemental tungsten, which is the

material used in this shot, is virtually insoluble and is therefore

expected to be relatively nontoxic. Even though most toxicity tests

reviewed were based on soluble tungsten compounds rather than elemental

tungsten (while the toxicity of the polymers is negligible due to its

insolubility), there appears to be no basis for concern of toxicity to

wildlife for the TM shot (metallic tungsten and polymers) via ingestion

by fish, birds, or mammals (Wildlife International Ltd., 1998; Bursian

et al., 1996; Gigiema, 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 in acids and does not

easily complex. Preferential uptake by plants in acid soil suggests

that uptake of tungsten in the anionic form is associated with tungsten

minerals rather than elemental tungsten (Kabata-Pendias and Pendias

1984).

Environmental Concentrations

Calculation of the estimated environmental concentration (EEC) of

tungsten in a terrestrial ecosystem is based on 69,000 shot per hectare

(Pain 1990), assuming complete erosion of material in 5 cm of soil. The

EECs for tungsten and the 2 polymers in soil are 25.7 mg/kg, 4.2 mg/kg,

and 0.14 mg/kg, respectively. Calculation of the EEC in an aquatic

ecosystem assumes complete erosion of the shot in one cubic foot of

water. The EECs in water for tungsten and the 2 polymers are 4.2 mg/L,

0.2 mg/L, and 0.02 mg/L, respectively. The TM shot is considered

insoluble and is stable in basic, neutral, and mildly acidic

environments. Therefore, erosion of shot is expected to be minimal, and

adverse effects on biota are not expected to occur.

Effects on Birds

An extensive literature review provided information on the toxicity

of elemental tungsten to waterfowl and other birds. Ringelman et al.

(1993), orally dosed 20 8-week-old game-farm mallards with 12-17

(1.03g) tungsten-bismuth-tin (TBT) pellets and monitored them for 32

days for evidence of intoxication. No birds died during the trial,

gross lesions were not observed during the postmortem examination,

histopathological examinations did not reveal any evidence of toxicity

or tissue damage, and tungsten was not detectable in kidney or liver

samples. The authors concluded that TBT shot presented virtually no

potential for acute intoxication in mallards.

Kraabel et al. (1996) assessed the effects of embedded TBT shot on

mallards and concluded that TBT was not acutely toxic when implanted in

muscle tissue. Inflammatory reactions to TBT shot were localized and

had no detectable systemic effects on mallard health.

Nell et al. (1981) fed laying hens (Gallus domesticus) 0.4 or 1 g/

kg tungsten in a commercial mash for five months to assess reproductive

performance. Weekly egg production was normal and hatchability of

fertile eggs was not affected. Exposure of chickens to large doses of

tungsten either through injection or by feeding, resulted in an

increased tissue concentration of tungsten and a decreased

concentration of molybdenum (Nell et al. 1981). The loss of tungsten

from the liver occurred in an exponential manner with a half-life of 27

hours. The alterations in molybdenum metabolism seemed to be associated

with tungsten intake rather than molybdenum deficiency. Death due to

tungsten occurred when tissue concentrations increased to 25 mg/g

liver. At that concentration, xanthine dehydrogenase activity was zero.

The two plastic polymers used in TM shot act as a physical matrix

in which the tungsten is distributed as ionically-bound fine particles.

Most completely polymerized nylon materials are physiologically inert,

regardless of the toxicity of the monomer from which they are made

(Peterson, 1977). A literature review did not reveal studies in which

either of the two polymers were evaluated for toxicity in birds.

Montgomery (1982) reported that feeding Nylon 6 to rats at a level of

25 percent of the diet for 2 weeks caused a slower rate of weight gain,

presumably due to a decrease in food consumption and feed efficiency.

However, the rats suffered no anatomic injuries due to the consumption

of nylon.

Kent's 30-day dosing study on the original formulation (Wildlife

International Ltd., 1998) included 4 treatment and 1 control group of

game-farm mallards. Treatment groups were exposed to 1 of 3 different

types of shot: 8 #4 steel, 8 #4 lead, or 8 #4 TM; whereas the control

group received no shot. The 2 TM treatment groups (1 group deficient

diet, 1 group balanced diet) each consisted of 16 birds (8 males and 8

females); whereas remaining treatment and control groups consisted of 6

birds each (3 males and 3 females). All TM-dosed birds survived the

test and showed no overt signs of toxicity or treatment-related effects

on body weight. There were no differences in hematocrit or hemoglobin

concentration between the TM treatment group and either the steel shot

or control groups. No histopathological lesions were found during gross

necropsy. In general, no adverse effects were seen in mallards given 8

#4 size TM shot and monitored over a 30-day period. Tungsten was found

to be below the limit of detection in all samples of femur, gonad,

liver, and kidney from treatment groups.

Based on the results of the toxicological report and the toxicity

test of the original shot formulation (Tier 1 and 2), the Service

concludes that TM shot, (approximately 95.9 percent tungsten and 4.1

percent polymer, by weight with <1 percent residual lead), does not

appear to pose a significant danger to migratory birds or other

wildlife and their habitats. However, the Service has some concern that

absorption of tungsten into the femur,

[[Page 55842]]

kidney, and liver, as noted in a separate study on mallards, could

potentially affect the spectacled eider (Somateria fischeri); a species

already subject to adverse weather, predation, and lead poisoning on

the Yukon-Kuskokwim (Y-K) Delta, Alaska. Until a reproductive/chronic

toxicity test has been completed and the Service has reviewed the

results, TM shot cannot be approved for the Y-K Delta.

The first condition of approval is toxicity testing. Candidate

materials not approved under Tier 1 and/or 2 testing are subjected to

standards of Tier 3 testing. The scope of Tier 3 includes chronic

exposure under adverse environmental conditions and effects on

reproduction in game-farm mallards, as outlined in 50 CFR

20.134(b)(4)(i)(A and B) (Tier 3), 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 long-term toxicity under depressed temperature conditions

using a nutritionally-deficient diet, as well as a moderately long-term

study that includes reproductive assessment. The tests require the

applicant to demonstrate that TM shot is nontoxic to waterfowl and

their offspring.

The second condition of final unconditional approval is testing for

residual lead levels. Any TM shot with lead levels equal to or

exceeding 1 percent will be considered toxic and, therefore, illegal.

In the Federal Register of August 18, 1995 (60 FR 43314), the Service

indicated that it would establish a maximum level for residual lead.

The Service has determined that the maximum environmentally acceptable

level of lead in any nontoxic shot is trace amounts of <1 percent and

has incorporated this requirement (50 CFR 20.134(b)(5)) in the December

1, 1997, final rule (62 FR 63608). Kent documented that the TM 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 TM shot from lead shot.

Furthermore, TM shot can be drawn to a magnet as a simple field

detection method. This requirement was incorporated into regulations at

50 CFR 20.134(b)(6) in the December 1, 1997, final rule (62 FR 63608).

This proposed rule would amend 50 CFR 20.21(j) by conditionally

approving tungsten-matrix shot as nontoxic for the 1998-99 migratory

bird hunting season throughout the United States, except for the Y-K

Delta in Alaska. It is based on the request made to the Service by Kent

Cartridge on September 18, 1997 (subsequently modified), the

toxicological reports, and the acute toxicity studies. Results of the

toxicological report and 30-day toxicity test undertaken for Kent

Cartridge indicate the apparent absence of any deleterious effects of

tungsten-matrix shot when ingested by captive-reared mallards or to the

ecosystem. The comment period for the proposed rule has been shortened

to 30 days. This time frame will make it possible for tungsten-matrix

shot, if temporarily approved, to be available for use by hunters

during the 1998-1999 hunting season. This will increase the number of

nontoxic shot options available to hunters.

References

Bursian, S. J., M. E. Kelly, R. J. Aulerich, D. C. Powell, and S.

Fitzgerald. 1996. Thirty-day dosing test to assess the toxicity of

tungsten-polymer shot in game-farm mallards. Report to Federal

Cartridge Co. 77 pp.

Gigiema I Sanitariya. 1983. Mezhdunarodnaya Kniga. Moscow, USSR.

48(7):77.

Industrial Medicine. 1946. Volume 15, p. 482.

Interagency Ecosystem Management Task Force. 1995. The ecosystem

approach: healthy ecosystems and sustainable economics. Volume II--

Implementation Issues.

Kabata-Pendias, A. and H. Pendias. 1984. Trace elements in soil and

plants. CRC Press, Inc. Boca Raton, FL.

Karantassis, T. 1924. On the toxicity of compounds of tungsten and

molybdenum. Ann. Med. 28:1541091543.

Kraabel, F. W., M. W. Miller, D. M. Getzy, and J. K. Ringleman.

1996. Effects of embedded tungsten-bismuth-tin shot and steel shot

on mallards. J. Wildl. Dis. 38(1):1098.

Montgomery, R. R. 1982. Polymers. In Patty's Industrial Hygiene and

Toxicology, Vol. IIIA (G.D. Clayton and F. E. Clayton, Eds.) pp.

4209-4526. John Wiley and Sons, NY.

Nell, J. A; Bryden, W.L.; Heard, G. S.; Balnave, D. 1981.

Reproductive performance of laying hens fed tungsten. Poultry

Science 60(1):257-258.

Pain, D.J. 1990. Lead shot ingestion by waterbirds in the Carmarque,

France: an investigation of levels and interspecific difference.

Environ. Pollut. 66:273-285.

Patty's Industrial Hygiene and Toxicology. 1981. Wiley Interscience.

Wiley & Sons, Inc. NY, NY. Third Ed.

Peterson, J. E. 1977. Industrial Health. Prentice-Hall, Englewood

Cliffs, NJ.

Ringelman, J. K., M. W. Miller and W. F. Andelt. 1993. Effects of

ingested tungsten-bismuth-tin shot on mallards. CO Div. Wildl., Fort

Collins, 24 pp.

Thomas, V.G. 1997. Application for approval of tungsten-matrix shot

as non-toxic for the hunting of migratory birds. 39 pp.

Wildlife International, Ltd. 1998. Tungsten-matrix shot: An oral

toxicity study with the mallard. Project No. 475-101. 162 pp.

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 parts 1500-1508), the Service prepared a draft

Environmental Assessment (EA) in October 1998. This EA is available to

the public for comment at the location indicated under the ADDRESSES

caption.

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 * * * '' The Service has initiated a Section 7

consultation under the ESA for this proposed rule. The result of the

Service's consultation under Section 7 of the ESA will be available to

the public at the location indicated under the ADDRESSES caption.

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 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. The

approved shot will merely supplement nontoxic shot already in

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commerce and available throughout the retail and wholesale distribution

systems, therefore, this rule would have minimal effect on such

entities. The Service anticipates no dislocation or other local effects

with regard to hunters and others. This document is not a significant

rule subject to Office of Management and Budget review under Executive

Order 12866. This rule does not contain collections of information that

require approval by the Office of Management and Budget under 44 U.S.

C. 3501 et seq.

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 Department has determined that these proposed regulations meet

the applicable standards provided in Sections 3(a) and 3(b)(2) of

Executive Order 12988.

Authorship

The primary author of this proposed rule is James R. Kelley, Jr.,

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 I of Title 50 of the Code of Federal Regulations

is proposed to be 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)(4) to read as follows:

Sec. 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 tungsten-polymer (95.5 parts tungsten: 4.5

parts Nylon 6 or 11 with <1 percent residual lead) shot, or tungsten-

matrix (95.9 parts tungsten: 4.1 parts polymer with <1 percent residual

lead), or such shot approved as nontoxic by the Director pursuant to

procedures set forth in 20.134, provided that:

(1) * * *

(4) Tungsten-matrix shot (95.9 parts tungsten: 4.1 parts polymer

with <1 percent residual lead) is legal as nontoxic shot for waterfowl

and coot hunting for the 1998-1999 hunting season only, except for the

Yukon-Kuskokwim Delta habitat in Alaska.

Dated: October 13, 1998.

Donald J. Barry,

Assistant Secretary for Fish and Wildlife and Parks.

[FR Doc. 98-27906 Filed 10-16-98; 8:45 am]

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