[Federal Register Volume 63, Number 235 (Tuesday, December 8, 1998)]
[Rules and Regulations]
[Pages 67619-67624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32470]


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DEPARTMENT OF INTERIOR

Fish and Wildlife Service

50 CFR Part 20

RIN 1018-AE38


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

AGENCY: Fish and Wildlife Service, Interior.

ACTION: Final rule.

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SUMMARY: The U.S. Fish and Wildlife Service (Service) amends Section 
20.21(j) to grant temporary conditional approval of tungsten-matrix 
shot as nontoxic for the 1998-99 migratory bird hunting season only, 
except in the Yukon-Kuskokwim (Y-K) Delta, Alaska, while chronic 
toxicity/reproductive testing is being completed. Tungsten-matrix shot 
has been submitted for consideration as nontoxic by Kent

[[Page 67620]]

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

DATES: This rule takes effect immediately upon publication on December 
8, 1998.

ADDRESSES: Copies of the 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, DC 20240. 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 has increased 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 will grant 
temporary conditional approval for the 1998-99 hunting season only. 
Final approval will not be granted until chronic toxicity/reproductive 
testing is successfully completed and the results are reviewed and 
approved by the Director.
    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-
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 several metal components. 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's updated application includes a description of the 
reformulated tungsten-matrix 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, the 
Service determined that testing of the reformulated shot in the form of 
a new 30-day dosing study was not necessary.
    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 tungsten-matrix 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. Tungsten-matrix 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

[[Page 67621]]

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 tungsten-matrix 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 tungsten-matrix; whereas 
the control group received no shot. The 2 tungsten-matrix 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 
tungsten-matrix-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 
tungsten-matrix 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 
tungsten-matrix 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 tungsten-matrix 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, 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 chronic toxicity/reproductive testing has 
been successfully completed and the Service has reviewed and approved 
the results, tungsten-matrix 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 tungsten-matrix shot is nontoxic to waterfowl and 
their offspring.
    The second condition of final unconditional approval is testing for 
residual lead levels. Any tungsten-matrix 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 
tungsten-matrix shot has 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. This requirement was incorporated 
into regulations at 50 CFR 20.134(b)(6) in the December 1, 1997, final 
rule (62 FR 63608). A noninvasive field testing device is under 
development to separate tungsten-matrix shot from lead shot. Tungsten-
matrix shot cannot be drawn to a magnet as a simple field detection 
method. The Service incorrectly stated in the proposed rule of October 
19, 1998, that tungsten-matrix was magnetic (63 FR 55842).
    In summary, this rule amends 50 CFR 20.21(j) by temporarily 
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. Final unconditional approval of tungsten-matrix shot as 
nontoxic for the entire U.S. will not be considered until all required 
chronic toxicity/reproductive tests have been successfully completed 
and the results are reviewed and approved by the Director.

Public Comments and Responses

    The October 19, 1998, proposed rule published in the Federal 
Register (63 FR 55840) invited public comments from interested parties. 
The closing date for receipt of all comments was November 18, 1998. 
During this 30-day comment period, the Service received eight comments.
    The California Waterfowl Association strongly supported the 
proposed temporary approval of tungsten-matrix shot for the 1998-99 
season. They believed that temporary approval of tungsten-matrix shot 
was an important step to address concerns relating to efforts to reduce 
unnecessary crippling of waterfowl through development of more 
effective nontoxic shot materials.
    The Wildlife Legislative Fund of America encouraged the Service to 
approve tungsten-matrix shot for the 1998-99 season. They believe that 
approval of tungsten-matrix would help fulfill the objective of making 
lead shot substitutes available to hunters.
    The International Association of Fish and Wildlife Agencies 
supported temporary and conditional approval of tungsten-matrix shot 
for the 1998-99 season. They acknowledged that final approval is 
pending successful completion of further testing.
    The Wisconsin Department of Natural Resources (Wisconsin) supported 
temporary approval of tungsten-matrix

[[Page 67622]]

provided there is no scientific evidence that indicates it is toxic to 
waterfowl or the environment. However, Wisconsin expressed concern 
about the timing of the proposed and final rules and the confusion that 
it creates for hunters. They encouraged the Service to initiate 
publication of rules concerning nontoxic shot before August 1 to allow 
proper planning by States.
    The National Rifle Association urged the Service to temporarily 
approve tungsten-matrix shot for the remainder of the 1998-99 season. 
They further expressed their support of research and development of 
ballistically efficient nontoxic shot ammunition.
    The WILDFOWL.NET organization expressed concern that the Service 
has not taken steps to approve tungsten-matrix shot in a prompt manner. 
They questioned why the Service could not approve a generic tungsten 
shotload, in a manner similar to steel shot. Finally, they inquired 
whether the Service intends to either arrest and/or cite waterfowl 
hunters that use tungsten-matrix shot prior to granting final approval 
of the shot.
    Kent Cartridge Company (Kent) supported prompt conditional approval 
of tungsten-matrix shot for the 1998-99 waterfowl hunting season. They 
stated that they fully intend to complete chronic toxicity/reproductive 
testing on tungsten-matrix shot that is required before final approval 
can be considered. Kent pointed out that the concentration of lead in 
their shot is below the 1 percent level that the Service has stipulated 
for nontoxic shot. Furthermore, they indicated that noninvasive field 
testing equipment for detecting tungsten-matrix shot is expected to be 
available shortly.
    The Federal Cartridge Company (Federal) noted that a complete 
description of candidate shot materials must be submitted to the 
Director, and that a complete description of tungsten-matrix shot was 
not published in the Federal Register. Federal also questioned whether 
the 2 percent iron, referenced in the initial application, was removed 
from the candidate shot as it was not mentioned in the October 19 
proposed rule description. Lastly, Federal questioned whether tungsten-
matrix shot could be drawn to a magnet as a field test method.
    Service Response: Regarding the timing of the rulemaking, the 
Service recognizes the information dissemination problems caused by 
conditionally approving tungsten-matrix shot at this time. However, the 
Service acts on nontoxic shot applications as they are received. 
Therefore, when applications are approved, either conditionally or 
permanently, the Service proceeds with the application process 
regardless of the timing of hunting seasons. Because Kent's application 
was being treated under the old nontoxic shot approval process, which 
provided for conditional approval, the Service decided to proceed with 
this rulemaking. Providing another nontoxic shot option for hunting 
waterfowl and coots likely will improve hunter compliance, thereby 
reducing the amount of lead shot in the environment.
    Regarding the assertion that the Service has not processed 
temporary approval of tungsten-matrix shot in a prompt manner, we 
stress that the Service made every attempt to process Kent's 
application as quickly as possible.
    Regarding the question of whether approval can be given for generic 
tungsten shots, we point out that for the three tungsten shot 
applications currently being processed by the Service (tungsten-iron, 
tungsten-polymer, and tungsten-matrix), no data has been submitted on 
the required chronic toxicity/reproductive tests. Without such 
information, it would not be prudent to approve a generic tungsten shot 
type. The revised test protocol for nontoxic approval procedures (50 
CFR 20.134) published in the Federal Register on December 1, 1997 (62 
FR 63608) established a three-tier approval process. The system has 
three tiers, with each tier enhancing the information base on the 
candidate material. Those candidate materials where appropriate 
background information, toxicological data, ecological risk assessment, 
and reproductive effects information are available demonstrating the 
candidate material to be benign may receive nontoxic approval. 
Applications for nontoxic approval of candidate shots submitted after 
December, 1997, must satisfy all information requirements determined by 
the Service before any form of approval can be granted. Without chronic 
toxicity/reproductive test data (Tier 3) there would be insufficient 
information to approve future tungsten shot applications under the new 
test protocol. Furthermore, depending on the specific composition of 
future tungsten candidate shot types and associated concerns over their 
toxicity, there may be sufficient cause for requiring additional 
information before approval can be granted.
    Regarding whether the Service intends to arrest or cite waterfowl 
hunters that use tungsten-matrix shot prior to granting final permanent 
approval of the shot, we would like to clarify that the Service is not 
requiring final permanent approval of tungsten-matrix shot before 
making it legal for the 1998-99 season. Final permanent approval of 
tungsten-matrix will not be considered until results from chronic 
toxicity/reproductive testing, scheduled to be conducted during spring 
1999, are submitted to the Service for review. We emphasize that this 
rule grants temporary approval of the shot for hunting waterfowl and 
coots for the remainder of the 1998-99 hunting season only. Therefore, 
as of the publication date of this rule and for the remainder of the 
1998-99 season only, hunters using tungsten-matrix to hunt waterfowl 
and coots during the current season would be in compliance with the law 
and should not be cited.
    The Service is pleased that Kent intends to complete the required 
chronic toxicity/reproductive testing of their tungsten-matrix shot. We 
look forward to reviewing the results of such tests as soon as possible 
so that a decision can be made on the shot's nontoxic status before the 
1999-2000 hunting season.
    Regarding the questions on shot composition, the composition of 
tungsten-matrix shot approved by this rule is not magnetic and no 
longer contains 2 percent iron. Both of these issues were oversights on 
our part in the October 19 proposed rule. Regarding the completeness of 
the description of the subject shot material, Kent included a complete 
description of tungsten-matrix shot in their application to the 
Service, including the specific polymers used in the shot. Sufficient 
information was contained in Kent's application to allow the Service to 
assess short-term toxicity of the shot and subsequently grant temporary 
approval for the remainder of the 1998-99 hunting season. Because Kent 
requested that the Service not divulge proprietary information 
concerning the nature of the polymers used in their shot, the exact 
description of the polymers will not be published.

Effective Date

    Under the APA (5 U.S.C. 553 (d)) the Service waives the 30-day 
period before the rule becomes effective and finds that ``good cause'' 
exists, within the terms of 5 U.S.C. 553(d)(3) of the APA, and this 
rule will, therefore, take effect immediately upon publication. This 
rule relieves a restriction and, in addition, it is not in the public 
interest to delay the effective date of this rule. During the public 
comment period for temporary conditional approval the Service received 
eight comments. Of these comment letters, six were from conservation 
organizations, one was from a State natural resource agency,

[[Page 67623]]

and one was from an ammunition manufacturer. All objections/comments 
have been remedied satisfactorily and are discussed under the Public 
Comment and Responses section of this document. It is in the best 
interest of migratory birds and their habitats to grant temporary 
conditional approval to tungsten-matrix shot as nontoxic for the 1998-
99 migratory bird hunting season. It is in the best interest of the 
hunting public to provide them an additional legal option for hunting 
waterfowl and coots for the 1998-99 season, which began on September 1, 
1998. It is in the best interest of small retailers who have stocked 
tungsten-matrix shot for the current season. The Service believes 
another nontoxic shot option likely will improve hunter compliance, 
thereby reducing the amount of lead shot in the environment.

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 (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 in 
October 1998. This EA is available to the public at the location 
indicated under the ADDRESSES caption. Based on review and evaluation 
of the information in the EA, the Service has determined that amending 
50 CFR 20.21(j) to extend temporary approval of tungsten-matrix shot as 
nontoxic for the 1998-99 migratory bird hunting season 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 Federal agencies 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 completed 
a Section 7 consultation under the ESA for this rule and determined 
that granting temporary approval of tungsten-matrix shot for the 1998-
99 hunting season, except on the Yukon-Kuskokwin (Y-K) Delta, is not 
likely to affect any threatened, endangered, proposed or candidate 
species. The result of the Service's consultation under Section 7 of 
the ESA is available to the public at the location indicated under the 
ADDRESSES caption.

Regulatory Flexibility 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), under the Regulatory Flexibility Act (5 U.S.C. 
601, et seq.), was issued by the Service in 1998 (copies available upon 
request from the Office of Migratory Bird Management). 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 1996 National Hunting and Fishing Survey which it 
was estimated that migratory bird hunters would spend between $429 and 
$1084 million nationwide at small businesses in 1998. The approval of 
tungsten-matrix as an alternative shot to steel will have a minor 
positive impact on small businesses by allowing them to sell another 
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.

Executive Order 12866

    This rule was not subject to Office of Management and Budget (OMB) 
review under Executive Order 12866. E.O. 12866 requires each agency to 
write regulations that are easy to understand. The Service invites 
comments on how to make this rule easier to understand, including 
answers to questions such as the following: (1) Are the requirements in 
the rule clearly stated? (2) Does the rule contain technical language 
or jargon that interferes with its clarity? (3) Does the format of the 
rule (grouping and order of sections, use of headings, paragraphing, 
etc.) aid or reduce its clarity? (4) Would the rule be easier to 
understand if it were divided into more (but shorter) sections? (5) Is 
the description of the rule in the ``Supplementary Information'' 
section of the preamble helpful in understanding the rule? What else 
could the Service do to make the rule easier to understand?
    Send a copy of any comments that concern how this rule could be 
made easier to understand to: Office of Regulatory Affairs, Department 
of the Interior, Room 7229, 1849 C Street, N.W., Washington, D.C. 
20240. Comments may also be e-mailed to: E[email protected].

[[Page 67624]]

Congressional Review

    In accordance with Section 251 of the Small Business Regulatory 
Enforcement Fairness Act of 1996 (5 U.S.C. 8), this rule has been 
submitted to Congress. Because this rule deals with the Service's 
migratory bird hunting program, this rule qualifies for an exemption 
under 5 U.S.C. 808(1); therefore, the Department determines that this 
rule shall take effect immediately.

Paperwork Reduction Act

    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The Service has examined this 
regulation under the Paperwork Reduction Act of 1995 and found it to 
contain no information collection requirements. However, the Service 
does have OMB approval (1018-0067; expires 06/30/2000) for information 
collection relating to what manufacturers of shot are required to 
provide the Service for the nontoxic shot approval process. For further 
information see 50 CFR 20.134.

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.

Takings Implication Assessment

    In accordance with Executive Order 12630, these rules, authorized 
by the Migratory Bird Treaty Act, do not have significant takings 
implications and do not affect any constitutionally protected property 
rights. These rules will not result in the physical occupancy of 
property, the physical invasion of property, or the regulatory taking 
of any property. In fact, these rules allow hunters to exercise 
privileges that would be otherwise unavailable; and, therefore, reduce 
restrictions on the use of private and public property.

Federalism Effects

    Due to the migratory nature of certain species of birds, the 
Federal government has been given responsibility over these species by 
the Migratory Bird Treaty Act. These rules do not have a substantial 
direct effect on fiscal capacity, change the roles or responsibilities 
of Federal or State governments, or intrude on State policy or 
administration. Therefore, in accordance with Executive Order 12612, 
these regulations do not have significant federalism effects and do not 
have sufficient federalism implications to warrant the preparation of a 
Federalism Assessment.

Government-to-Government Relationship With Tribes

    In accordance with the President's memorandum of April 29, 1994, 
``Government-to-Government Relations with Native American tribal 
Governments'' (59 FR 22951) and 512 DM 2, we have evaluated possible 
effects on Federally recognized Indian tribes and have determined that 
there are no effects.

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 record-keeping 
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)(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) shot, 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: December 1, 1998.
Donald J. Barry,
Assistant Secretary for Fish and Wildlife and Parks.
[FR Doc. 98-32470 Filed 12-7-98; 8:45 am]
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