[Federal Register Volume 63, Number 201 (Monday, October 19, 1998)]
[Proposed Rules]
[Pages 55840-55843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27906]


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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-

[[Page 55841]]

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

[[Page 55843]]

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]
BILLING CODE 4310-55-P