[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