[Federal Register Volume 66, Number 3 (Thursday, January 4, 2001)]
[Rules and Regulations]
[Pages 737-742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-139]


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DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

50 CFR Part 20

RIN 1018-AH64


Migratory Bird Hunting; Approval of Tungsten-Nickel-Iron Shot as 
Nontoxic for Hunting Waterfowl and Coots

AGENCY: Fish and Wildlife Service, Interior.

ACTION: Final rule.

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SUMMARY: We amend 50 CFR 20.21(j) to approve shot formulated of 50% 
tungsten, 35% nickel, and 15% iron as nontoxic for hunting waterfowl 
and coots. We assessed possible effects of the tungsten-nickel-iron 
(TNI) shot, and we believe that it is not a significant threat to 
wildlife or their habitats and that further testing of the shot is not 
necessary. In addition, approval of TNI shot may induce more waterfowl 
hunters to switch away from illegal use of lead shot, reducing lead 
risks to species and habitats.

DATES: This rule takes effect on January 4, 2001.

ADDRESSES: Copies of the Environmental Assessment are available from 
the Chief of the Division of Migratory Bird Management, U.S. Fish and 
Wildlife Service, 4401 North Fairfax Drive, Room 634, Arlington, 
Virginia 22203-1610.

FOR FURTHER INFORMATION CONTACT: Jon Andrew, Chief, or Dr. George T. 
Allen, Division of Migratory Bird Management, 703-358-1714.

SUPPLEMENTARY INFORMATION: The Migratory Bird Treaty Act of 1918 (Act) 
(16 U.S.C. 703-712 and 16 U.S.C. 742 a-j) implements migratory bird 
treaties between the United States and Great Britain for Canada (1916 
and 1996 as amended), Mexico (1936 and 1972 as amended), Japan (1972 
and 1974 as amended), and Russia (then the Soviet Union, 1978). These 
treaties protect certain migratory birds from take, except as permitted 
under the Act. The Act authorizes the Secretary of the Interior to 
regulate take of migratory birds in the United States. Under this 
authority, the Fish and Wildlife Service controls the hunting of 
migratory game birds through regulations in 50 CFR part 20.
    Since the mid-1970s, we have sought to identify shot that does not 
pose a significant toxicity hazard to migratory birds or other 
wildlife. Compliance with the use of nontoxic shot has increased over 
the last few years (Anderson et al. 2000). We believe that it will 
continue to increase with the approval and availability of other 
nontoxic shot types. Currently, steel, bismuth-tin, tungsten-iron, 
tungsten-polymer, and tungsten-matrix shot are permanently approved as 
nontoxic. We have approved tin shot for the 2000-2001 hunting season 
(65 FR 76886). The purpose of this rule is to approve the use of TNI 
shot in the tested formulation (50% tungsten, 35% nickel, and 15% iron 
by weight) for waterfowl and coot hunting. On October 30, 2000 (65 FR 
64650) we proposed to amend 50 CFR 20.21 (j), to include TNI shot on 
the list of approved nontoxic shot types.
    On April 9, 1999 (64 FR 17308), we announced receipt of an 
application from Standard Resources Corporation (Standard) of Cherry 
Hill, New Jersey for nontoxic approval of HEVI-METAL shot in the 50% 
tungsten, 35% nickel, 15% iron formulation. The density of the shot in 
that formulation is 11.0 grams/cm\3\. The manufacturer believes that 
the shot does not need a coating because it is sufficiently 
noncorrosive under neutral pH. It is not chemically or physically 
altered by firing from a shotgun.

[[Page 738]]

    On April 19, 1999 (64 FR 19191), we announced that Standard's 
application did not provide sufficient information for us to conclude 
that the candidate shot is not a significant danger to migratory birds. 
We advised Standard to proceed with additional testing of the candidate 
shot. Subsequently, development of HEVI-METAL was transferred to 
ENVIRON-Metal, Inc., of Albany, Oregon (Environ-metal), and the shot 
was re-named HEVI-SHOT<SUP>TM</SUP>.
    On August 10, 2000, Environ-metal submitted an application for 
permanent approval of the tungsten-nickel-iron shot as nontoxic for 
hunting waterfowl and coots. The application included a description of 
the shot, results and a toxicological report of a preliminary 30-day 
dosing study of the toxicity of the shot in game-farm mallards 
(Ecological Planning and Toxicology, Inc. [EPT] 1999), and results of a 
more comprehensive 30-day acute toxicity study (Brewer and Fairbrother 
2000).

Toxicity Information

    Tungsten may be substituted for molybdenum in enzymes in mammals. 
Ingested tungsten salts reduce growth, and can cause diarrhea, coma, 
and death in mammals (e.g. Bursian et al. 1996, Cohen et al. 1973, 
Karantassis 1924, Kinard and Van de Erve 1941, National Research 
Council 1980, Pham-Huu-Chanh 1965), but elemental tungsten is virtually 
insoluble and therefore essentially nontoxic. In rats, a dietary 
concentration of 94 parts-per-million (ppm) did not reduce weight gain 
in growing rats (Wei et al. 1987). Lifetime exposure to 5 ppm tungsten 
as sodium tungstate in drinking water produced no discernible adverse 
effects in rats (Schroeder and Mitchener 1975). At 100 ppm tungsten as 
sodium tungstate in drinking water, rats had decreased enzyme activity 
after 21 days (Cohen et al. 1973). These studies indicate that tungsten 
salts are very toxic to mammals.
    Chickens given a complete diet showed no adverse effects of 250 ppm 
sodium tungstate administered for 10 days in the diet. However, 500 ppm 
in the diet had detrimental effects on day-old chicks (Teekell and 
Watts 1959). Adult hens had reduced egg production and egg weight on a 
diet containing 1,000 ppm tungsten (Nell et al. 1981a). EPT (1999) 
concluded that 250 ppm in the diet would produce no observable adverse 
effects. Kelly et al. (1998) demonstrated no adverse effects on 
mallards dosed with tungsten-iron or tungsten-polymer shot according to 
nontoxic shot test protocols.
    Most toxicity tests reviewed were based on soluble tungsten 
compounds rather than elemental tungsten. As we found in our reviews of 
other tungsten shot types, we believe that there is no basis for 
concern about the toxicity of the tungsten in TNI shot to fish, 
mammals, or birds.
    Nickel is a dietary requirement of mammals, with necessary 
consumption set at 50 to 80 parts per billion for the rat and chick 
(Nielsen and Sandstead 1974). Though it is necessary for some enzymes, 
nickel can compete with calcium, magnesium, and zinc for binding sites 
on many enzymes. Water-soluble nickel salts are poorly absorbed if 
ingested by rats (Nieboer et al. 1988). Nickel carbonate caused no 
treatment effects in rats fed 1,000 ppm for 3 to 4 months (Phatak and 
Patwardhan 1952). Rats fed 1,000 ppm nickel sulfate for 2 years showed 
reduced body and liver weights, an increase in the number of stillborn 
pups, and decrease in weanling weights through three generations 
(Ambrose et al. 1976). Nickel chloride was even more toxic; 1,000 ppm 
fed to young rats caused weight loss in 13 days (Schnegg and 
Kirchgessner 1976).
    Soluble nickel salts can be classified as very toxic to mammals, 
with an oral LD<INF>50</INF> of 136 mg/kg in mice, and 350 mg/kg in 
rats (Fairchild et al. 1977). Nickel catalyst (finely divided nickel in 
vegetable oil) fed to young rats at 250 ppm for 16 months, however, 
produced no detrimental effects (Phatak and Patwardhan 1952).
    In chicks from hatching to 4 weeks of age, 300 ppm nickel as nickel 
carbonate or nickel acetate in the diet produced no observed adverse 
effects. However, concentrations of 500 ppm or more reduced growth 
(Weber and Reid 1968). A diet containing 200 ppm nickel as nickel 
sulfate had no observed effects on mallard ducklings from 1 to 90 days 
of age. Diets of 800 ppm or more caused significant changes in physical 
condition of the ducklings (Cain and Pafford 1981). Eastin and O'Shea 
(1981) observed no apparent significant changes in pairs of breeding 
mallards fed diets containing up to 800 ppm nickel as nickel sulfate 
for 90 days.
    Iron is an essential nutrient, so reported iron toxicosis in 
mammals is primarily a phenomenon of overdosing of livestock. Maximum 
recommended dietary levels of iron range from 500 ppm for sheep to 
3,000 ppm for pigs (National Research Council [NRC] 1980). Chickens 
require at least 55 ppm iron in the diet (Morck and Austic 1981). 
Chickens fed 1,600 ppm iron in an adequate diet displayed no ill 
effects (McGhee et al. 1965). Turkey poults fed 440 ppm in the diet 
suffered no adverse effects. The tests in which eight #4 tungsten-iron 
shot were administered to each mallard in a toxicity study indicated 
that the 45% iron content of the shot had no adverse effects on the 
test animals (Kelly et al. 1998).

Environmental Fate

    Elemental tungsten and iron are virtually insoluble in water and do 
not weather and degrade in the environment. Tungsten is stable in acids 
and does not easily form compounds with other substances. Preferential 
uptake by plants in acidic soil suggests uptake of tungsten when it has 
formed compounds with other substances rather than when it is in its 
elemental form (Kabata-Pendias and Pendias 1984).
    Nickel is common in fresh waters, though usually at concentrations 
of less than 1 part per billion in locations unaffected by human 
activities. Pure nickel is not soluble in water. Free nickel may be 
part of chemical reactions, such as sorption, precipitation, and 
complexation. Reactions of nickel with anions are unlikely. 
Complexation with organic agents is poorly understood (U.S. 
Environmental Protection Agency [EPA] 1980). Water hardness is the 
dominant factor governing nickel effects on biota (Stokes 1988).

Environmental Concentrations

    Calculation of the estimated environmental concentration (EEC) of a 
candidate shot in a terrestrial ecosystem is based on 69,000 shot per 
hectare (Bellrose 1959, 50 CFR 20.134). Assuming complete dissolution 
of the shot, the EEC for tungsten in soil is 19.3 mg/kg. The EECs for 
nickel and iron would be 7.7 and 3.3 mg/kg, respectively. The EEC for 
nickel (the only one of the three elements with an application limit) 
is substantially below the U.S. Environmental Protection Agency (EPA) 
biosolid application limit. The 3.3 mg/kg EEC for nickel also is far 
below the 16 to 35 mg/kg concentrations suggested as minimum sediment 
concentrations at which effects of the metal are likely to occur (EPA 
1997, Ingersoll et al. 1996, Long and Morgan 1991; MacDonald et al. 
2000, Smith et al. 1996). The EEC for tungsten from TNI shot is below 
that for the already-approved tungsten-matrix shot. The EEC for iron is 
less than 0.01% of the typical background concentration, and the iron 
is in an insoluble form.
    Calculation of the EEC in an aquatic ecosystem assumes complete 
erosion of the 69,000 shot/hectare in water 1 foot deep. The EECs for 
the elements in TNI shot in water are 2,348 <greek-m>g/L for tungsten, 
1,643 <greek-m>g/L for nickel, and 704 <greek-m>g/L for iron. We 
concluded that a tungsten concentration of 10,500 <greek-m>g/L

[[Page 739]]

posed no threat to aquatic biota (62 FR 4877). The EEC for nickel, if 
the shot were completely dissolved, would exceed the EPA acute water 
quality criterion of 1,400 <greek-m>g/L in fresh water, and would 
greatly exceed the 75 <greek-m>g/L criterion for salt water. However, 
tests showed that corrosion of TNI shot is negligible in neutral pH 
fresh water. Actual tests in water with a pH of 2 showed that the EEC 
for nickel would be 83.98 <greek-m>g/L, and in salt water it would be 
7.92 <greek-m>g/L; both are far below the EPA criterion of 160 
<greek-m>g/L for chronic exposure.

Effects on Birds

    Kraabel et al. (1996) surgically embedded tungsten-bismuth-tin shot 
in the pectoralis muscles of ducks to simulate wounding by gunfire and 
to test for toxic effects of the shot. The authors found that the shot 
neither produced toxic effects nor induced adverse systemic effects in 
the ducks during the 8-week period of their study.
    Nell et al. (1981a) 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 et al. 1981b). 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 ppm in the liver. At that concentration, xanthine dehydrogenase 
activity was zero.

Toxicity Studies

    Ringelman et al. (1993) conducted a 32-day acute toxicity study 
that involved dosing game-farm mallards with a shot alloy which was 
39%, 44.5%, and 16.5% by weight, respectively. No dosed birds died 
during the trial, and behavior was normal. Post-euthanization 
examination of tissues revealed no toxicity or damage related to shot 
exposure. Blood calcium differences between dosed and undosed birds 
were judged to be unrelated to shot exposure. That study indicated that 
tungsten presented little hazard to waterfowl.
    Initial analyses of corrosion of TNI shot in 0.1N HCl and in 
seawater indicated that it is more corrosion resistant than copper-
plated tungsten-iron shot and steel shot, and that it will release 
tungsten into the environment more slowly than does tungsten-iron shot. 
In addition, only a portion of the tungsten is soluble, and not all of 
that is absorbed. Therefore, EPT (1999) suggested that ingested TNI 
shot should pose minimal risks to migratory birds that might ingest it.
    EPT conducted a preliminary 30-day oral toxicity study of TNI shot 
that followed the general approach outlined for a short-term acute 
toxicity test (50 CFR 20.134). Eight #4 TNI shot pellets were 
administered to each of three healthy adult male and three healthy 
adult female mallards by placing them in a gelatin capsule and placing 
the capsule in the bird's gizzard. All of the birds retained seven or 
eight of the pellets for the 30-day test period. During that time the 
birds behaved normally, and none of them exhibited signs of metal 
intoxication. Body weights of the birds did not change significantly 
during the test period.
    Upon postmortem examination, all body organs looked normal. 
Histopathology showed that one of the females had a fatty liver, and 
also had elevated liver enzymes. Liver abnormalities due to fatty 
changes (accumulation of glycogen or fat) were considered the likely 
cause of the problem.
    Brewer and Fairbrother (2000) reported on the outcome of more 
extensive corrosion/erosion testing of TNI shot, and steel and lead 
shot. Eight #4 TNI shot pellets were administered to each of 20 male 
mallards and 20 female mallards by placing the shot in a gelatin 
capsule and placing the capsule in the bird's gizzard. The same 
procedure was followed for dosing 20 male mallards and 20 female 
mallards with 8 #4 steel shot, and for dosing 5 males and 5 females 
with 8 #4 lead shot. The birds had been fasting prior to placement of 
the gelatin capsules to facilitate movement of the capsule to the 
gizzard. During the 30-day test period, the researchers monitored loss 
of shot through the digestive system, and they determined retention of 
shot in the gizzard upon necropsy. They also carefully monitored food 
consumption of the test birds and their health.
    No mortality occurred in birds treated with TNI shot or steel shot. 
Nine of the ten birds dosed with lead died during the test period. 
Therefore, most measures of health and measures of shot erosion were 
not valid for the lead-dosed group. No significant differences in body 
weight changes emerged between the steel shot group and the TNI shot 
group during the test period.
    The evaluation focused on corrosion/erosion of the steel shot and 
the TNI shot, and associated changes in organs and blood chemistry. A 
total of 134 of the TNI shot pellets and 138 of the steel shot were 
recovered from the gizzards of the test birds after 30 days. TNI shot 
pellets recovered from gizzards at the end of the test retained an 
average of 88.6% of their initial weight; steel pellets retained an 
average of 49.7% of their weight.
    Histopathological examination of kidney tissues from the 41 ducks 
alive at the end of the test period revealed no significant lesions. 
Livers also appeared to have been unaffected by steel pellets or TNI 
shot. Hemoglobin, white blood cell counts, hematocrits, and blood serum 
chemistry results did not differ between the steel shot test group and 
the TNI shot test group, with the exception that the mean for plasma 
protein was significantly higher in the TNI shot-treated ducks.
    Analytical chemistry of liver, kidney, and blood samples showed 
some differences between the steel shot and TNI shot test groups. Mean 
tungsten concentrations in blood, liver, and kidney tissues were 0.24 
ppm in the blood, 0.64 ppm in kidney tissue, and 1.65 ppm in liver 
tissue. No tungsten was detected in tissues of mallards dosed with 
steel shot. Mean nickel concentrations in blood (0.03 ppm), liver (0.09 
ppm), and kidney (0.44 ppm) tissues were significantly higher in ducks 
dosed with TNI shot than in those dosed with steel shot. Mean nickel 
concentrations in blood, liver, and kidney tissues of mallards treated 
with 800 ppm in the diet for 90 days were 0.139, 0.52, and 1.94 ppm, 
respectively (Eastin and O'Shea 1991). Those ducks suffered no apparent 
ill effects from their treatment. Mean iron concentrations in the blood 
and liver were higher for the ducks dosed with steel shot, but kidney 
concentrations did not differ.
    EPT (1999) calculated that the mallards studied by Eastin and 
O'Shea (1981) consumed approximately 102 mg of nickel each day during 
the study. Under the Tier 2 protocol, each test mallard is dosed with 8 
#4 shot at 0, 30, 60, and 90 days, which in the case of TNI shot would 
contain a total of 32 shot, and 2.3 g of nickel per bird. At pH 2, with 
continual grinding of ingested shot, eight #4 pellets would lose 0.176 
mg of nickel per day. The maximum exposure for a mallard under such 
conditions would be 0.704 mg/day, substantially less than the estimated 
consumption by mallards in the Eastin

[[Page 740]]

and O'Shea study (EPT 1999). We believe, therefore, that consumption of 
nickel from TNI shot is unlikely to have detrimental effects on 
waterfowl.

Ingestion by Fish, Amphibians, Reptiles, or Mammals

    Based on the available information and past reviews of tungsten-
based shot, we expect no detrimental effects due to tungsten or iron on 
animals that might ingest TNI shot. However, we know of no studies of 
ingestion of nickel by herpetofauna. In the worst case, assuming 
complete erosion of a #4 TNI shot pellet equal to that found in a 
mallard gizzard, exposure to a vertebrate would be approximately 0.022 
mg of nickel per day if the shot were retained in the animal. The 
exposure actually would be substantially less because a shot pellet 
likely would not be retained in most animals that might consume one.

Nontoxic Shot Approval

    The first condition for nontoxic shot approval is toxicity testing. 
Based on the results of the toxicological reports and the toxicity 
tests, we conclude that TNI shot does not pose a significant danger to 
migratory birds, other wildlife, or their habitats.
    The second condition for approval is testing for residual lead 
levels. Any shot with a lead level of 1% or more will be illegal. We 
determined that the maximum environmentally acceptable level of lead in 
shot is 1%, and incorporated this requirement in the nontoxic shot 
approval process we published on December 1, 1997 (62 FR 63607). 
ENVIRON-Metal, Inc. has documented that TNI shot meets this 
requirement.
    The third condition for approval involves enforcement. On August 
18, 1995 (60 FR 43313), we stated 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. TNI shotshells can be drawn to a 
magnet as a simple field detection method.
    This final rule will amend 50 CFR 20.21(j) by approving TNI shot as 
nontoxic for migratory bird hunting. It is based on the toxicological 
reports, acute toxicity studies, and assessment of the environmental 
effects of the shot. Those results indicate no deleterious effects of 
TNI shot to ecosystems or when ingested by waterfowl.

Public Comments

    We received one comment on the October 30, 2000 proposed rule to 
approve TNI shot for hunting waterfowl and coots. That comment 
supported granting approval for use of the shot.

References

Anderson, W. L., S. P. Havera, and B. W. Zercher. 2000. Ingestion of 
lead and nontoxic shotgun pellets by ducks in the Mississippi 
flyway. Journal of Wildlife Management 64:848-857.
Ambrose, P., P. S. Larson, J. F. Borzelleca, and G. R. Hennigar, Jr. 
1976. Long term toxicologic assessment of nickel in rats and dogs. 
Journal of Food Science and Technology 13:181-187.
Bellrose, F. C. 1959. Lead poisoning as a mortality factor in 
waterfowl populations. Illinois Natural History Survey Bulletin 
27(3): 235-288.
Brewer, L. and A. Fairbrother. 2000. Corrosion/erosion of Hevi-shot 
nontoxic shot in mallard duck gizzards. EBA, Inc., Snow Camp, North 
Carolina. 152 pages.
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 Company. 71 pages.
Cain, B. W. and E. A. Pafford. 1981. Effects of dietary nickel on 
survival and growth of mallard ducklings. Archives of Environmental 
Contamination and Toxicology 10:737-745.
Cohen, H. J., R. T. Drew, J. L. Johnson, and K. V. Rajagopalan. 
1973. Molecular basis of the biological function of molybdenum: the 
relationship between sulfite oxidase and the acute toxicity of 
bisulfate and SO2. Proceedings of the National Academy of Sciences 
70:3655-3659.
Eastin, W. C., Jr. and T. J. O'Shea. 1981. Effects of dietary nickel 
on mallards. Journal of Toxicology and Environmental Health 7:883-
892.
Ecological Planning and Toxicology, Inc. 1999. Application for 
approval of t-n-i metal\TM\ nontoxic shot: Tier 1 report. Cherry 
Hill, New Jersey. 28 pages plus appendixes.
Fairchild, E. J., R. J. Lewis, and R. L. Tatken (editors). 1977. 
Registry of toxic effects of chemical substances, Volume II. Pages 
590-592. U.S. Department of Health, Education, and Welfare 
Publication (NIOSH) 78-104B. 227 pages.
Ingersoll, C. G., P. S. Haverland, E. L. Brunson, T.J. Canfield, F. 
J. Dwyer, C. E. Henke, N. E. Kemble, and D. R. Mount. 1996. 
Calculation and evaluation of sediment effect concentrations for the 
amphipod Hyalella azteca and the midge Chironomus riparius. EPA 905-
R96-008, Great Lakes National Program Office, Region V, Chicago, 
Illinois. Mixed pagination.
Kabata-Pendias, A. and H. Pendias. 1984. Trace elements in soils and 
plants. CRC Press, Inc. Boca Raton, FL. 315 pages.
Karantassis, T. 1924. On the toxicity of compounds of tungsten and 
molybdenum. Annals of Medicine 28:1541-1543.
Kelly, M. E., S. D. Fitzgerald, R. J. Aulerich, R. J. Balander, D. 
C. Powell, R. L. Stickle. W. Stevens, C. Cray, R. J. Tempelman, and 
S. J. Bursian. 1998. Acute effects of lead, steel, tungsten-iron and 
tungsten-polymer shot administered to game-farm mallards. Journal of 
Wildlife Diseases 34:673-687.
Kinard, F. W. and J. Van de Erve. 1941. The toxicity of orally-
ingested tungsten compounds in the rat. Journal of Pharmacology and 
Experimental Therapeutics 72:196-201.
Kraabel, F. W., M. W. Miller, D. M. Getzy, and J. K. Ringelman. 
1996. Effects of embedded tungsten-bismuth-tin shot and steel shot 
on mallards. Journal of Wildlife Diseases 38:1-8.
Long, E. R. and L. G. Morgan. 1991. The potential for biological 
effects of sediment-sorbed contaminants tested in the National 
Status and Trends Program. NOAA Technical Memorandum NOS OMA 52, 
National Oceanic and Atmospheric Administration, Seattle, 
Washington. 175 pages + appendices.
MacDonald, D. D., C. G. Ingersoll, and T. A. Berger. 2000. 
Development and evaluation of consensus-based sediment quality 
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Contamination and Toxicology 39:20-31.
McGhee, F., C. R. Creger, and J. R. Couch. 1965. Copper and iron 
toxicity. Poultry Science 44:310-312.
Morck, T. A. and R. E. Austic. 1981. Iron requirements of white 
leghorn hens. Poultry Science 60:1497-1503.
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animals. National Research Council, National Academy of Sciences, 
Washington, D.C. 577 pages.
Nell, J. A., W. L. Bryden, G. S. Heard, and D. Balnave. 1981a. 
Reproductive performance of laying hens fed tungsten. Poultry 
Science 60:257-258.
Nell, J. A., E. F. Annison, and D. Balnave. 1981. The influence of 
tungsten on the molybdenum status of poultry. British Poultry 
Science 21:193-202.
Nieboer, E., R. T. Tom, and W. E. Sanford. 1988. Nickel metabolism 
in man and animals. Pages 91-122 in Metal ions in biological 
systems, volume 23: nickel and its role in biology. H. Sigel and A. 
Sigel, editors. Marcel Dekker, New York.
Nielsen, F. H. and H. H. Sandstead. 1974. Are nickel, vanadium, 
silicon, fluoride, and tin essential for man? American Journal of 
Clinical Nutrition 27:515-520.
Pham-Huu-Chanh. 1965. The comparative toxicity of sodium chromate, 
molybdate, tungstate, and metavanadate. Archives Internationales de 
Pharmacodynamie et de Therapie 154:243-249.
Phatak, S. S. and V. N. Patwardhan. 1950. Toxicity of nickel. 
Journal of Science and Industrial Research 9B:70-76.
Ringelman, J. K., M. W. Miller, and W. F. Andelt. 1993. Effects of 
ingested tungsten-bismuth-tin shot on captive mallards. Journal of 
Wildlife Management 57:725-732.
Schnegg, S. and M. Kirchgessner. 1976. [Toxicity of dietary nickel]. 
Landwirtsch. Forsch. 29:177. Cited in Chemical Abstracts 86:101655y 
(1977).
Schroeder, H. A. and M. Mitchener. 1975. Life-term studies in rats: 
effects of aluminum, barium, beryllium, and tungsten. Journal of 
Nutrition 105:421.

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Smith, S. L., D. D. MacDonald, K. A. Keenleyside, C. G. Ingersoll, 
and J. Field. 1996. A preliminary evaluation of sediment quality 
assessment values for freshwater ecosystems. Journal of Great Lakes 
Research 22:624-638.
Stokes, P. 1988. Nickel in aquatic systems. Pages 31-46 in Metal 
ions in biological systems, volume 23: nickel and its role in 
biology. H. Sigel and A. Sigel, editors. Marcel Dekker, New York.
Teekel, R. A. and A. B. Watts. 1959. Tungsten supplementation of 
breeder hens. Poultry Science 38:791-794.
U.S. Environmental Protection Agency. 1980. Ambient water quality 
criteria for nickel. U.S. Environmental Protection Agency, 
Washington, D.C. 207 pages.
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severity of sediment contamination in surface waters of the United 
States: National sediment quality survey, Volume 1. EPA 823-R-97-
006. Office of Science and Technology, Washington, D.C. 182 pages 
plus appendices.
U.S. Fish and Wildlife Service. 1986a. Environmental Assessment: 
copper/nickel plating on nontoxic shot. U.S. Fish and Wildlife 
Service, Washington, D.C. 3 pages.
U.S. Fish and Wildlife Service. 1986b. Finding of no significant 
impact: copper/nickel plating on nontoxic shot. U.S. Fish and 
Wildlife Service, Washington, D.C. 1 page.
Weber, C. W. and B. L. Reid. 1968. Nickel toxicity in growing 
chicks. Journal of Nutrition 95:612-616.
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tungsten on mammary carcinogenesis in Sprague-Dawley (SD) rats. 
Chung Hua Chung Liu Tsa Chih 9:204-7. English abstract.

Required Determinations

NEPA Consideration

    In compliance with the requirements of section 102(2)(C) of the 
NEPA and the Council on Environmental Quality's regulation for 
implementing NEPA (40 CFR 1500), we prepared a final Environmental 
Assessment (EA) for approval of TNI shot in December 2000. The EA is 
available to the public at the location indicated in the ADDRESSES 
section. Based on review and evaluation of the information contained in 
the EA, we have determined that amending 50 CFR 20.21(j) to approve TNI 
shot as nontoxic for waterfowl and coot hunting would not be a major 
Federal action that would significantly affect the quality of the human 
environment within the meaning of section 102(2)(c) of the National 
Environmental Policy Act of 1969 (NEPA). Accordingly, the preparation 
of an Environmental Impact Statement on this action is not required.

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 completed a Section 7 consultation 
under the ESA for this rule, which is available to the public at the 
location indicated in the ADDRESSES section. The Division of Endangered 
Species concurred with our determination that this rule is ``Not Likely 
to Affect'' endangered or threatened species.

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. This rule approves an additional type of nontoxic shot 
that may be sold and used to hunt migratory birds; this rule will add 
one shot type to those already approved. We have determined, however, 
that this rule will have no effect on small entities since the approved 
shot 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 or 
others.

Executive Order 12866

    This rule has not been reviewed by the Office of Management and 
Budget (OMB) review under Executive Order 12866. OMB makes the final 
determination of significance under Executive Order 12866.

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. We have received OMB 
approval of continued collection of information from shot manufacturers 
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 
Reform 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.

Small Business Regulatory Enforcement Fairness Act

    This rule is not a major rule under 5 U.S.C. 804(2), the Small 
Business Regulatory Enforcement Fairness Act. It does not have an 
annual effect on the economy of $100 million or more; nor will it cause 
a major increase in costs or prices for consumers, individual 
industries, Federal, State, or local government agencies, or geographic 
regions. This rule has the potential for reducing the present cost of 
nontoxic shot by making additional materials available for consumers. 
It does not have significant adverse effects on competition, 
employment, investment, productivity, innovation, or the ability of 
U.S.-based enterprises to compete with foreign-based enterprises. This 
rule may provide beneficial effects to competition, employment, 
investment, productivity, innovation, and the ability of U.S.-based 
enterprises to compete with foreign-based enterprises.

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, this rule, authorized by 
the Migratory Bird Treaty Act, does not have significant takings 
implications and does not affect any constitutionally protected 
property rights. This rule will not result in the physical occupancy of 
property, the physical invasion of property, or the regulatory taking 
of any property. In fact, this rule will allow hunters to exercise 
privileges that would be otherwise unavailable; and, therefore, reduces 
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. This rule does 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 13132, 
this regulation does not have significant federalism effects and does 
not have sufficient federalism implications to

[[Page 742]]

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 determined that this 
rule has no effects on Federally recognized Indian tribes.

Effective Date

    Under the APA (5 U.S.C. 551-553) our normal practice is to publish 
policies with a 30-day delay in effective date. In this case, however, 
we use the ``good cause'' exemption under 5 U.S.C. 553(d)(3) to make 
this rule effective upon publication. This rule relieves a restriction, 
and it is not in the public interest to delay its effective date. We 
believe that another nontoxic shot option likely will improve hunter 
compliance, thereby reducing the amount of lead shot in the 
environment.

List of Subjects in 50 CFR Part 20

    Exports, Hunting, Imports, Reporting and recordkeeping 
requirements, Transportation, Wildlife.

    For the reasons discussed in the preamble, we propose to amend 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) to read as 
follows:


Sec. 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 tungsten-
nickel-iron (50% tungsten: 35% nickel: 15% iron with 1 percent residual 
lead), or such shot approved as nontoxic by the Director pursuant to 
procedures set forth in Sec. 20.134, provided that this restriction 
applies only to the taking of Anatidae (ducks, geese, (including brant) 
and swans), coots (Fulica americana) and any species that make up 
aggregate bag limits during concurrent seasons with the former in areas 
described in Sec. 20.108 as nontoxic shot zones, and further provided 
that:
    (1) Tin shot (99.9 percent tin with 1 percent residual lead) is 
legal as nontoxic shot for waterfowl and coot hunting for the 2000-2001 
hunting season only.
    (2) [Reserved]

    Dated: December 27, 2000.
Kenneth L. Smith,
Assistant Secretary for Fish and Wildlife and Parks.
[FR Doc. 01-139 Filed 1-3-01; 8:45 am]
BILLING CODE 4310-55-P