[Federal Register Volume 64, Number 160 (Thursday, August 19, 1999)]
[Rules and Regulations]
[Pages 45400-45405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21525]


      

[[Page 45399]]

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Part VI





Department of the Interior





_______________________________________________________________________



Fish and Wildlife Service



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50 CFR Part 20



Migratory Bird Hunting; Final Approval of Tungsten-Iron and Tungsten-
Polymer Shots and Temporary Approval of Tungsten-Matrix and Tin Shots 
as Nontoxic for Hunting Waterfowl and Coots; Final Rule

  Federal Register / Vol. 64, No. 160 / Thursday, August 19, 1999 / 
Rules and Regulations  

[[Page 45400]]



DEPARTMENT OF INTERIOR

Fish and Wildlife Service

50 CFR Part 20

RIN 1018-AF65


Migratory Bird Hunting; Final Approval of Tungsten-Iron and 
Tungsten-Polymer Shots and Temporary Approval of Tungsten-Matrix and 
Tin Shots as Nontoxic for Hunting Waterfowl and Coots

AGENCY: Fish and Wildlife Service, Interior.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The U.S. Fish and Wildlife Service (Service or we) amends 
Section 20.21(j) to grant final approval of tungsten-iron and tungsten-
polymer shots as nontoxic for hunting waterfowl and coots. We also 
grant temporary approval of tungsten-matrix and tin shots as nontoxic 
for hunting waterfowl and coots during the 1999-2000 hunting season 
only. Acute toxicity studies reveal no adverse effects over a 30-day 
period on mallards (Anas platyrhynchos) dosed with either tungsten-
iron, tungsten-polymer, tungsten-matrix, or tin shot. Reproductive/
chronic toxicity testing over a 150-day period indicated that tungsten-
iron and tungsten-polymer administered to adult mallards did not 
adversely affect them or the offspring they produced. We will not 
consider final approval of tungsten-matrix and tin shots until all 
required reproductive/chronic toxicity tests are successfully completed 
and the results are received and approved by the Director. Tungsten-
iron and tungsten-polymer shots are produced by Federal Cartridge 
Company (Federal) of Anoka, Minnesota. Tungsten-matrix shot is produced 
by Kent Cartridge Company (Kent) of Kearneysville, West Virginia. Tin 
shot is produced by the International Tin Research Institute (ITRI) of 
Uxbridge, Middlesex, Great Britain.

DATES: This rule takes effect immediately upon publication on August 
19, 1999.

ADDRESSES: Copies of the Environmental Assessments are available by 
writing to the Chief, Office of Migratory Bird Management (MBMO), U.S. 
Fish and Wildlife Service, 4401 N. Fairfax Dr., Suite 634, Arlington, 
VA 22203.

FOR FURTHER INFORMATION CONTACT: Jon Andrew, Chief, Office of Migratory 
Bird Management, (703) 358-1714.

SUPPLEMENTARY INFORMATION: Since the mid-1970s, we have 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 as nontoxic. We previously granted temporary 
approval for tungsten-iron shot during the 1997-98 (August 13, 1997; 62 
FR 43444) and 1998-99 (October 7, 1998; 63 FR 54016) migratory bird 
hunting seasons. We also granted temporary approval for tungsten-
polymer (October 7, 1998; 63 FR 54022) and tungsten-matrix (December 8, 
1998; 63 FR 67619) shots during the 1998-99 migratory bird hunting 
season. Compliance with the use of nontoxic shot has increased over the 
last few years. We believe that compliance will continue to increase 
with the approval and availability of other nontoxic shot types.
    Federal Cartridge Company's (Federal) tungsten-iron shot is an 
alloy of approximately 40 percent tungsten and 60 percent iron, by 
weight, and has a density of approximately 10.3 g/cm\3\. Tungsten-
polymer shot is a matrix of Nylon 6 or 11 polymer surrounding particles 
of elemental tungsten. Shot made from this material has a density of 
approximately 11.2 g/cm\3\ or approximately the density of lead. The 
shot will contain approximately 95.5 percent tungsten and 4.5 percent 
Nylon 6 or 11 by weight).
    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. The tungsten-
matrix material from which pellets are formulated has a specific 
gravity of 9.8 g/cm\3\ and is composed of 88 percent tungsten, 4 
percent nickel, 2 percent iron, 1 percent copper, and 5 percent 
polymers by mass. After consultation with us, Kent has 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/cm\3\ 
and is composed of approximately 95.9 percent tungsten and 4.1 percent 
polymers.
    ITRI's candidate shot is made from commercially pure tin; no 
alloying or other alterations are intentionally made to the chemical 
composition of the shot. This shot material has a density of 
approximately 7.29 g/cm\3\, and is 99.9 percent tin, with a low level 
of iron pickup due to the steel production equipment.
    Each of Federal's applications for tungsten-iron and tungsten-
polymer include a description of the shot, a toxicological report (Barr 
1996), results of a 30-day dosing study of the toxicity of the shot in 
game-farm mallards (Bursian et al. 1996a, Bursian et al. 1996b), and 
results of a 150-day reproductive/chronic toxicity study (Bursian et 
al. 1999). Kent's application for tungsten-matrix includes a 
description of the shot, a toxicological report (Thomas 1997a), and 
results of a 30-day toxicity study (Wildlife International, Ltd. 
1998a). The tin shot application from ITRI contains a description of 
the shot, a toxicological report (Thomas 1997b), and results of a 30-
day toxicity study (Wildlife International, Ltd. 1998b). Toxicological 
reports for each shot type 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 (shot alteration, environmental half-
life, and environmental concentration).

Toxicity Information

    There is considerable difference in the toxicity of soluble and 
insoluble compounds of tungsten and iron. Elemental tungsten and iron 
are virtually insoluble and are therefore expected to be relatively 
nontoxic. Even though most toxicity tests reviewed were based on 
soluble tungsten compounds rather than elemental tungsten, there 
appears to be no basis for concern of toxicity to wildlife for either 
candidate shot via ingestion by fish or mammals (Bursian et al. 1996b, 
Gigiena 1983, Karantassis 1924, Patty 1982, Industrial Medicine 1946). 
Detailed reviews of the toxicological impacts of different tin 
compounds have been conducted by Eisler (1989) and Cooney (1988). Both 
reviews indicate that elemental tin is non-toxic to animals. Tin shot 
designed for waterfowl hunting is utilized in several European 
countries and no reports exist that suggest that tin shot is causing 
toxicity problems for wildlife in those countries.
    The potential toxicity of nylon compounds due to degradation is 
primarily associated with the stabilizers, antioxidants, plasticizers, 
and unreacted prepolymers. Residual caprolactum has been found in some 
commercial Nylon 6 products, but little concern regarding this compound 
has been developed (Patty, 1982). The toxicity of Nylon 6 and 11 are 
negligible due to their insolubilities.

Environmental Fate and Transport

    Tungsten is insoluble in water and therefore not mobile in 
hypergenic

[[Page 45401]]

environments. Tungsten is very stable with acids and does not easily 
complex. Preferential uptake by plants in acid soil suggests uptake of 
tungsten in the anionic form associated with tungsten minerals rather 
than elemental tungsten (Kabata and Pendias 1984). Tin pellets will 
undergo slow surface oxidation to form hydrated tin oxide, which is 
extremely insoluble in water (Lide 1990). Therefore dissolution will be 
slow, and highly localized aqueous concentrations will not arise. This 
means that elemental tin will over time remain largely in the same 
inorganic form as when it is discharged. Tin pellets discharged into 
wetlands where sulphur ions are released during organic decomposition 
would become coated with tin sulphide, which is highly insoluble in 
water and resistant to aquatic hydrolysis (Hoiland 1995).

Environmental Concentration

    The effective environmental concentration (EEC) for a terrestrial 
ecosystem was calculated based on 69,000 shot per hectare (Pain 1990), 
assuming complete erosion of material in 5 cm of soil. For tungsten-
iron shot, the EEC for tungsten in soil was calculated at 32.9 mg/kg. 
For tungsten-polymer shot, the EECs for tungsten and Nylon (6 and 11) 
in soil are 58.3 mg/kg and 2.7 mg/kg, respectively. The EECs for 
tungsten and the 2 polymers found in tungsten-matrix are 25.7 mg/kg, 
4.2 mg/kg, and 0.14 mg/kg, respectively. The EEC for tin in soil is 
19.3 g/m3.
    The environmental concentration (EEC) for an aquatic ecosystem was 
calculated assuming complete erosion of the shot in one cubic foot of 
water. For tungsten-iron shot, the EEC in water for tungsten was 10.5 
mg/L. For tungsten-polymer shot, the EECs in water for tungsten and 
Nylon (6 and 11) are 18.7 mg/L and 0.9 mg/L, respectively. The EECs in 
water for tungsten and the 2 polymers found in tungsten-matrix are 4.2 
mg/L, 0.2 mg/L, and 0.02 mg/L, respectively. The EEC in water for tin 
is 19.3 mg/L.

Effects on Birds

    An extensive literature review in each application provided 
information on the toxicity of elemental tungsten and tin to waterfowl 
and other birds. Ringelman et al. (1993) orally dosed 20 8-week-old 
game-farm mallards with 12-17 (1.03 g average weight) 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 examinations, 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 (1981) fed laying hens (Gallus domesticus) 0.4 or 1.0 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 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.
    Ringelman et al. (1992) conducted a 32-day acute toxicity study 
which involved dosing game-farm mallards with a shot alloy of tungsten-
bismuth-tin (TBT), which was 39, 44.5 and 16.5 percent by weight, 
respectively. No dosed birds died during the trial, and behavior was 
normal. Examination of tissues post-euthanization revealed no toxicity 
or damage related to shot exposure. This study concluded that ``. . . 
TBT shot presents virtually no potential for acute intoxication in 
mallards under the conditions of this study.''
    Several studies have been conducted in which pellets made of tin or 
tin alloys have been placed inside the digestive tract or tissues of 
ducks to determine if toxic effects occur. Grandy et al. (1968) and the 
Huntingdon Research Centre (1987) conducted 30- and 28-day, 
respectively, acute toxicity tests on mallard ducks and reported that 
all treatment ducks survived with insignificant weight loss or 
development of pathological lesions. The potential for bismuth-tin (BT) 
shot to produce toxicological effects in ducks during reproduction has 
been investigated under both acute and chronic testing conditions. Tin 
as a 2% component of the tested shot, did not pose a toxic risk to 
ducks when fed a nutritionally-imbalanced, corn-based diet. Neither has 
BT shot been shown to pose an adverse risk to the health of ducks, the 
reproduction by male and female birds, nor the survival of ducklings 
over the long term (Sanderson et al. 1997a,b).
    Nylon 6 is the commercially important homopolymer of caprolactum. 
Most completely polymerized nylon materials are physiologically inert, 
regardless of the toxicity of the monomer from which they are made 
(Peterson 1977). Few data exist on the toxicity of Nylon 6 in animals. 
Most toxicity studies are related to thermal degradation products and 
so are not relevant to the exposure of wildlife to shot containing 
nylon. 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.
    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.

Acute Toxicity Studies

    Federal contracted with Michigan State University--Department of 
Animal Science, to conduct an acute toxicity study of tungsten-iron and 
tungsten-polymer. Both Kent and ITRI contracted with Wildlife 
International Ltd. to conduct an acute toxicity study of tungsten-
matrix and tin shots, respectively. The acute toxicity test is a short-
term (30-day) study where ducks are dosed with shot and fed 
commercially available duck food. Survival, body weight, blood 
hematocrit, and organ analysis are recorded.

Tungsten-iron and tungsten-polymer

    The 30-day dosing study revealed no adverse effects when mallards 
were dosed with either 8 BB size tungsten-iron shot or 8 BB size 
tungsten-polymer shot and monitored over a 30-day period (Bursian et 
al. 1996a, Bursian et al. 1996b). Eight male and 8 female adult 
mallards were dosed with either 8 No.4 steel shot, 8 No.4 lead shot, 8 
BB size tungsten-iron shot, or 8 BB size tungsten-polyer shot and 
observed over

[[Page 45402]]

a 30-day period. An additional 8 males and 8 females received no shot. 
Fifty percent of the lead-dosed birds (5 males and 3 females) died 
during the 30-day test while there were no mortalities in the other 
groups. Lead-dosed birds were the only ones to display green excreta, 
lethargy, and ataxia. Body weights were not significantly altered by 
any of the treatments, although lead-dosed birds which died during the 
trial lost an average of 30 percent of their body weight. Hematocrit, 
hemoglobin concentrations, and ALAD activity were significantly 
depressed at day 15 in the lead-dosed females, while lead-dosed males 
had significantly depressed hematocrit and hemoglobin concentration 
compared with the other four groups. There were no significant 
differences in these whole-blood parameters at day 30. Three tungsten-
polymer-dosed males developed mild biliary stasis. The authors 
attributed this to the intubating of mallards with 8 BBs of tungsen-
polymer shot inducing a pathological condition--however slight--that 
was not found in the control birds. No other histopathological lesions 
were found. Tungsten was detected in the femur of two tungsten-polymer-
dosed females and the kidneys of two tungsten-polymer-dosed birds; in 
both tissues, concentrations were only slightly above detection limits. 
In general, no adverse effects were seen in mallards given 8 BB-size 
tungsten-polymer shot and monitored over a 30-day period.

Tungsten-matrix

    Kent's 30-day dosing study (Wildlife International Ltd. 1998a) 
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.

Tin

    ITRI's 30-day dosing study (Wildlife International Ltd. 1998b) 
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 tin shot; whereas the control group received 
no shot. The 2 tin 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 tin-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 tin 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 tin shot and monitored over a 30-day period. No levels of tin 
above the limit of detection were observed in any tissues collected 
from either tin treatment group.

Reproductive/Chronic Toxicity Study

    Federal contracted with Michigan State University--Department of 
Animal Science, to conduct an a reproductive/chronic toxicity studies 
for both tungsten-iron and tungsten-polymer shot types. The 
reproductive/chronic toxicity study is a long-term (150-day) study 
where ducks are dosed with shot and fed commercially available duck 
food. Survival, body weight, blood hematocrit, organ analysis, and 
reproductive performance are recorded.

Tungsten-Iron and Tungsten-Polymer

    The reproductive/chronic toxicity study revealed no adverse effects 
when mallards were dosed with either 8 No. 4 size tungsten-iron shot, 
or 8 No. 4 size tungsten-polymer shot, and monitored over a 150-day 
period (Bursian et al. 1999). Sixteen male and 16 female adult mallards 
were orally dosed with either 8 No.4 steel shot, 8 No.4 tungsten-iron 
shot, or 8 No. 4 tungsten-polymer shot. An additional 6 male and 6 
female mallards were dosed with 8 No. 4 lead shot. All lead-dosed birds 
died by day 25 of the study, whereas no mortalities occurred in the 
other test groups. Lead-dosed birds had significantly decreased 
hematocrit, hemoglobin concentration and whole-blood delta 
aminolevulinic dehydratase activity on day 7 of the study. Mallards 
dosed with tungsten-iron or tungsten-polymer shot had occasional 
significant differences in hematocrit and plasma chemistry values when 
compared to steel-dosed mallards over the 150-day period, but these 
changes were within the normal range reported for mallards and were not 
considered to be deleterious. Relative kidney, heart, brain and gizzard 
weights of lead-dosed birds were significantly greater in comparison to 
relative weights of those organs in the other 3 treatment groups. 
Marked liver hemosiderosis was present in all steel and tungsten-dosed 
males, in 5 of 8 steel-and 3 of 8 tungsten-iron-dosed females, and in 1 
tungsten-polymer-dosed male examined. Small amounts of tungsten were 
detected in gonad and kidney samples from males and females, in femur 
samples of males, and in liver samples from females dosed with 
tungsten-polymer shot. Higher concentrations of tungsten were detected 
in femur, gonad, kidney, and liver samples from tungsten-iron-dosed 
ducks. The rate of shot erosion was 99% for tungsten-polymer, 72% for 
tungsten-iron, 55% for steel, and 37% for lead. There were no 
significant differences in percent egg production, and percent 
fertility and hatchability of eggs from tungsten-iron- and tungsten-
polymer-dosed ducks when compared to steel-dosed ducks. There were no 
biological differences in percent survivability and body weight of 
ducklings from tungsten-iron-or tungsten-polymer-dosed ducks when 
compared to ducklings from steel-dosed ducks. The hematocrit of 
ducklings from tungsten-iron-dosed ducks was slightly but significantly 
lower when compared to ducklings from steel-dosed ducks. Histological 
examination of duckling kidneys and liver indicated no abnormalities. 
Tungsten was detected in 25%, 9%, and 13% of the femur, kidneys, and 
liver samples, respectively, from ducklings of the tungsten-iron and 
tungsten-polymer groups. Overall, results of this study indicated that 
tungsten-iron and tungsten-polymer shot repeatedly administered to 
adult mallards did not adversely affect them or the offspring they 
produced during the 150-day trial.

Nontoxic Shot Approval

    The first condition of nontoxic shot approval is toxicity testing. 
Based on the results of the toxicological report and the toxicity tests 
(Tiers 1, 2, and 3) discussed above, we conclude that tungsten-iron and 
tungsten-polymer shot does not pose a significant danger to migratory 
birds or other wildlife and their habitats. Based on the results of 
toxicological reports and acute toxicity tests (Tier 1 and 2), we 
conclude that tungsten-matrix and tin shots do not

[[Page 45403]]

appear to pose a significant danger to migratory birds or other 
wildlife and their habitats. However, final approval of either shot 
type will not be considered until all required reproductive/chronic 
toxicity tests have been successfully completed and our Director has 
reviewed and approved the results.
    The second condition of approval is testing for residual lead 
levels. Any shot with lead levels equal to or exceeding 1 percent will 
be considered toxic and, therefore, illegal. We have determined that 
the maximum environmentally acceptable level of lead in any nontoxic 
shot is trace amounts of <1 percent, and incorporated this requirement 
in the nontoxic shot approval process that was published on December 1, 
1997 (62 FR 63608). Federal has documented that tungsten-iron and 
tungsten-polymer shots meet this requirement. Kent and ITRI have 
documented that tungsten-matrix and tin shot, respectively, meet this 
requirement.
    The third condition of approval involves enforcement. In the August 
18, 1995, Federal Register (60 FR 43314), we indicated that approval of 
any nontoxic shot would be contingent upon the development and 
availability of a noninvasive field testing device. This requirement 
was incorporated in the nontoxic shot approval process that was 
published on December 1, 1997 (62 FR 63608). Tungsten-iron shotshells 
can be drawn to a magnet as a simple field detection method. Electronic 
field testing devices can distinguish shells containing tungsten-
polymer and tungsten-matrix from shells containing lead. At the present 
time, we are not aware of any noninvasive field testing devices for 
distinguishing shells containing tin shot from those containing lead. 
We will not consider final approval of tin shot until such a device, or 
other noninvasive field testing method, has been developed for 
identifying tin shot.
    In summary, this rule amends 50 CFR 20.21(j) by approving tungsten-
iron and tungsten-polymer shots as nontoxic for migratory bird hunting. 
It is based on the toxicological reports, acute toxicity studies, and 
reproductive/chronic toxicity studies submitted by Federal. Results of 
these studies indicate the absence of any deleterious effects of 
tungsten-iron or tungsten-polymer shot when ingested by captive-reared 
mallards or to the ecosystem. This rule also grants temporary approval 
to tungsten-matrix and tin shots for the 1999-2000 hunting season only. 
Temporary approval is based on the toxicological reports and acute 
toxicity studies submitted by Kent and ITRI.
    During the 1998-99 hunting season, we granted temporary approval of 
several shot types that contained tungsten (October 7, 1998, 63 FR 
54016-54026; December 8, 1998, 63 FR 67619). We gave these approvals 
with the restriction that the shot types could not be used in the 
Yukon-Kuskokwim (Y-K) Delta, Alaska. This restriction was implemented 
out of concern for potential effects of tungsten on the spectacled 
eider (Somateria fischeri); a species subject to adverse weather, 
predation, and lead poisoning on the Y-K Delta. Based on the results of 
reproductive/chronic toxicity studies of tungsten-iron and tungsten-
polymer, we see no need for the Y-K Delta restriction on any tungsten-
based shot types.

Public Comments and Responses

    We invited public comments from interested parties in the June 17, 
1999, proposed rule published in the Federal Register (64 FR 32752). 
During the 30-day comment period, we received 4 comments.
    The Wildlife Legislative Fund of America strongly supported the 
temporary approval of tungsten-matrix and tin shots for hunting 
migratory birds in order to provide additional nontoxic shot 
alternatives to hunters.
    Senator John D. Rockefeller IV also supported the temporary 
approval of tungsten-matrix shot.
    Kent acknowledged the conditions for nontoxic approval and 
indicated that chronic toxicity/reproductive test results for tungsten-
matrix shot are proceeding satisfactorily.
    ITRI indicated that chronic toxicity/reproductive tests are being 
completed for tin shot and a noninvasive field testing device will be 
available.
    Service Response: We are encouraged that chronic toxicity/
reproductive testing is being completed for tungsten-matrix and tin 
shots, and look forward to reviewing results of such tests when they 
become available. It is our hope that providing additional nontoxic 
shot alternatives will improve hunter compliance and reduce the amount 
of lead shot in the environment.

Effective Date

    Under the APA (5 U.S.C. 553 (d)) we waive the 30-day period before 
this rule becomes effective and find 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. It is in the best interest of 
migratory birds and their habitats to grant approval to tungsten-iron 
and tungsten-polymer shot as nontoxic for hunting migratory birds, and 
to grant temporary approval to tungsten-matrix and tin shot for the 
1998-99 migratory bird hunting season only. It is in the best interest 
of the hunting public to provide them an additional legal option for 
hunting waterfowl and coots for the 1999-2000 season, which begins on 
September 1, 1999. It is in the best interest of small retailers who 
have stocked the above shot types for the current season. We believe 
that availability of additional nontoxic shot options likely will 
improve hunter compliance, thereby reducing the amount of lead shot in 
the environment.

References

Barr Engineering Company. 1996. Toxicology Report on New Shot.
Bursian, S. J., M. E. Kelly, R. J. Aulerich, D. C. Powell, and S. 
Fitzgerald. 1996a. Thirty-day dosing test to assess the toxicity of 
tungsten-iron shot in game-farm mallards. Report to Federal 
Cartridge Co. 77 pp.
Bursian, S. J., M. E. Kelly, R. J. Aulerich, D. C. Powell, and S. 
Fitzgerald. 1996b. Thirty-day dosing test to assess the toxicity of 
tungsten-polymer shot in game-farm mallards. Report to Federal 
Cartridge Co. 71 pp.
Bursian, S. J., R. M. Mitchell, R. J. Tempelman, R. J. Aulerich, and 
S. D. Fitzgerald. 1999. Chronic dosing study to assess the health 
and reproductive effects of tungsten-iron and tungsten-polymer shot 
on game-farm mallards. Report to Federal Cartridge Co. 115 pp.
Cooney, J.J. 1988. Microbial transformations of tin and tin 
compounds. J. Industr. Microbiol. 3:195-204.
Eisler, R. 1989. Tin hazards to fish, wildlife, and invertebrates: a 
synoptic review. Biological Rep. 85 (1.15). Contaminant Hazard 
Reviews Report No. 15. Fish and Wildlife Service, U.S. Dept. 
Interior. Washington, D.C. 85 pp.
Gigiema I. Sanitariya. 1977. Mezhdunarodnaya Kniga. Moscow, USSR. 
42(8):30.
Gigiema I. Sanitariya. 1983. Mezhdunarodnaya Kniga. Moscow, USSR. 
48(7):71.
Grandy, J. W., L. N. Locke, and G. E. Bagley. 1968. Relative 
toxicity of lead and five proposed substitute shot types to pen-
reared mallards. J. Wildl. Manage. 32(3):483-488.
Hoiland, K. 1995. Reaction of some decomposer basidiomycetes to 
toxic elements. Nordic J. Bot. 15:305-318.
Huntingdon Research Centre Ltd. 1987. The effects of dosing mallard 
ducks with Safe Shot. Huntingdon, Cambridge, U.K. Report dated Dec. 
19, 1987. 15pp.
Industrial Medicine. 1946. 15:482.
Interagency Ecosystem Management Task Force. 1995. The Ecosystem 
Approach: Healthy Ecosystems and Sustainable Economics. Volume II--
Implementation Issues.

[[Page 45404]]

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. 28:1541-1543.
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):1-8.
Lide, D.R. 1990. CRC--Handbook of Chemistry and Physics. 71st 
Edition, 1990-1991. CRC Press, Boca Raton, Florida.
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., E.F. Annison, and D. Balnave. 1981. The influence of 
tungsten on the molybdenum status of poultry. Br. Poult. Sci. 
21:193-202.
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. 1982. 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. 1992. Effects of 
ingested tungsten-bismuth-tin shot on mallards. CO Div. Wildl., Fort 
Collins, 24 pp.
Ringelman, J.K., M.W. Miller, and W.F. Andelt. 1993. Effects of 
ingested tungsten-bismuth-tin shot on captive mallards. J. Wildl. 
Manage. 57:725-732.
Sanderson, G.C., W.L. Anderson, G.L. Foley, L.M. Skowron, J.D. 
Brawn, and J.W. Seets. 1997a. Acute toxicity of ingested bismuth 
alloy shot in game farm mallards. Illinois Nat. History Survey Bull. 
35:185-216.
Sanderson, G.C., W.L. Anderson, G.L. Foley, K.L. Duncan, L.M. 
Skowron, J.D. Brawn, and J.W. Seets. 1997b. Toxicity of ingested 
bismuth alloy shot in game farm mallards: chronic health effects and 
effects on reproduction. Illinois Nat. History Survey Bull. 35:217-
252.
Thomas, V.G. 1997a. Application for approval of tungsten-matrix shot 
as non-toxic for the hunting of migratory birds. 39 pp.
Thomas, V.G. 1997b. Application for approval of tin shot as non-
toxic for the hunting of migratory birds. 26 pp.
Wildlife International, Ltd. 1998a. Tungsten-matrix shot: An oral 
toxicity study with the mallard. Project No. 475-101. 162 pp.
Wildlife International, Ltd. 1998b. Tin shot: An oral toxicity study 
with the mallard. Project No. 476-101. 158 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), we prepared Environmental Assessments (EA) in July, 
1999. The EAs are available to the public at the location indicated 
under the ADDRESSES caption. Based on review and evaluation of the 
information in the EAs, we have determined that amending 50 CFR 
20.21(j) to provide final approval of tungsten-iron and tungsten-
polymer shots, and temporary approval of tungsten-matrix and tin shots 
for the 1999-2000 season, as nontoxic for migratory bird hunting 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 * * *'' We have completed a Section 7 
consultation under the ESA for this rule, which stated the use of 
tungsten-iron, tungsten-polymer, tungsten-matrix, and tin shots is not 
likely to adversely affect listed species. The result of our 
consultation under Section 7 of the ESA is available to the public at 
the location indicated under the ADDRESSES caption.

Regulatory Flexibility Act; Small Business Regulatory Enforcement 
and Fairness 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. This rule approves additional types of nontoxic shot 
that may be sold and used to hunt migratory birds; this rule provides 4 
types of shot in addition to the existing 2 that are approved. We have 
determined, however, that this rule will have no effect on small 
entities since the approved shots merely will supplement nontoxic shot 
already in commerce and available throughout the retail and wholesale 
distribution systems. We anticipate no dislocation or other local 
effects, with regard to hunters and others. Similarly, this is not a 
major rule under 5 U.S.C. 804(2).

Executive Order 12866

    This rule is 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. We invite 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 we do 
to make the rule easier to understand?

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. We have examined this regulation 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501) and found it 
to contain no information collection requirements. However, we do have 
OMB approval (1018-0067; expires 06/30/2000) for information collection 
relating to what manufacturers of shot are required to provide to us 
for the nontoxic shot approval process. For further information see 50 
CFR 20.134.

Unfunded Mandates Reform

    We have determined and certify 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

    We, in promulgating this rule, have determined 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.

[[Page 45405]]

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 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, we are amending part 20, subchapter B, chapter 1 of 
Title 50 of the Code of Federal Regulations 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, revising paragraphs (j)(2) and (j)(3), and removing paragraph 
(j)(4) as follows:


20.21  What hunting methods are illegal?

* * * * *
    (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 (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 tin 
(99.9 percent tin 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:
* * * * *
    (2) 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 1999-2000 hunting season only, and
    (3) Tin shot (99.9 percent tin with <1 percent residual lead) is 
legal as nontoxic shot for waterfowl and coot hunting for the 1999-2000 
hunting season only.

    Dated: August 12, 1999.
Stephen C. Saunders,
Acting Assistant Secretary for Fish and Wildlife and Parks.
[FR Doc. 99-21525 Filed 8-18-99; 8:45 am]
BILLING CODE 4310-55-P