[Federal Register: May 6, 2005 (Volume 70, Number 87)]
[Proposed Rules]               
[Page 23954-23960]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06my05-20]                         

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DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

50 CFR Part 20

RIN 1018-AT87

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

AGENCY: Fish and Wildlife Service, Interior.

ACTION: Proposed rule, availability of Draft Environmental Assessment.

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SUMMARY: The U.S. Fish and Wildlife Service (we, us, or USFWS) proposes 
to approve shot formulated of 62 percent iron, 25 percent tungsten, and 
13 percent nickel as nontoxic for waterfowl and coot hunting in the 
United States. We assessed possible toxicity effects of the Iron-
Tungsten-Nickel (ITN) shot, and have determined that it is not a threat 
to wildlife or their habitats, and that further testing of ITN shot is 
not necessary. We have concluded that because all of the metals in ITN 
shot type have been approved in higher concentrations in other nontoxic 
shot types and in ITN shot are very unlikely to adversely affect fish, 
wildlife, their

[[Page 23955]]

habitats, or the human environment, we do not need to prepare an 
Environmental Assessment for this action. We believe that the toxicity 
risks from ITN shot are small.
    This rule also corrects the formulation of Tungsten-Tin-Bismuth 
shot. We inadvertently left the iron in the formulation out of our 
August 9, 2004, approval of the shot type (69 FR 48163).

DATES: Send comments on this proposal by June 6, 2005.

ADDRESSES: You may submit comments, identified by RIN 1018-AT87, by any 
of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the instructions for submitting comments.
     Agency Web Site: http://migratorybirds.fws.gov. Follow the 

links to submit a comment.
     E-mail address for comments: George_T_Allen@fws.gov. 
Include ``RIN 1018-AT87'' in the subject line of the message. Please 
submit electronic comments as text files; do not use file compression 
or any special formatting.
     Fax: 703-358-2217.
     Mail: Chief, Division of Migratory Bird Management, U.S. 
Fish and Wildlife Service, 4401 North Fairfax Drive, Mail Stop MBSP-
4107, Arlington, Virginia 22203-1610.
     Hand Delivery: Division of Migratory Bird Management, U.S. 
Fish and Wildlife Service, 4501 North Fairfax Drive, Room 4091, 
Arlington, Virginia 22203-1610.
    We will not accept anonymous comments. Comments will become part of 
the Administrative Record for the review of the application. You may 
inspect comments at the mailing address above during normal business 
hours.
    The Draft Environmental Assessment for approval of ITN shot is 
available from the Division of Migratory Bird Management, U.S. Fish and 
Wildlife Service, 4501 North Fairfax Drive, Room 4091, Arlington, 
Virginia 22203-1610. You may call 703-358-1825 to request a copy of the 
Draft Environmental Assessment.
    The complete file for this rule is available, by appointment, 
during normal business hours at the same address. You may call 703-358-
1825 to make an appointment to view the files.

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

SUPPLEMENTARY INFORMATION:

Background

    The Migratory Bird Treaty Act of 1918 (Act) (16 U.S.C. 703-711) and 
the Fish and Wildlife Improvement Act of 1978 (16 U.S.C. 712) implement 
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 Acts. The Acts authorize the Secretary of the 
Interior to regulate take of migratory birds in the United States. 
Under this authority, the U.S. Fish and Wildlife Service controls the 
hunting of migratory game birds through regulations in 50 CFR part 20.
    Deposition of toxic shot and release of toxic shot components in 
waterfowl hunting locations are potentially harmful to many organisms. 
Research has shown that ingested spent lead shot causes significant 
mortality in migratory birds. Since the mid-1970s, we have sought to 
identify shot types that do not pose significant toxicity hazards to 
migratory birds or other wildlife. We addressed the issue of lead 
poisoning in waterfowl in an Environmental Impact Statement in 1976, 
and again in a 1986 supplemental EIS. The 1986 document provided the 
scientific justification for a ban on the use of lead shot and the 
subsequent approval of steel shot for hunting waterfowl and coots that 
began that year, with a complete ban of lead for waterfowl and coot 
hunting in 1991. We have continued to consider other potential 
candidates for approval as nontoxic shot. We are obligated to review 
applications for approval of alternative shot types as nontoxic for 
hunting waterfowl and coots.
    We have received an application from ENVIRON-Metal, Inc. of Sweet 
Home, Oregon, for approval of Iron-Tungsten-Nickel shot formulated as 
62 percent iron, 25 percent tungsten, and 13 percent nickel by weight 
for waterfowl and coot hunting. We have reviewed the shot under the 
criteria in Tier 1 of the revised nontoxic shot approval procedures 
contained in 50 CFR 20.134 for permanent approval of shot as nontoxic 
for hunting waterfowl and coots. We propose to amend 50 CFR 20.21 (j) 
to add ITN shot to the list of the approved types of shot for waterfowl 
and coot hunting.
    The taxonomic family Anatidae, principally subfamily Anatinae 
(ducks) and their habitats, comprise the affected environment. 
Waterfowl habitats and populations in North America this year were 
described by the U.S. Fish and Wildlife Service (2004). In the Breeding 
Population and Habitat Survey traditional survey area (strata 1-18, 20-
50, and 75-77), the total-duck population estimate was 32.2 < plus-
minus> 0.6 ( 1 standard error) million birds, 11% below 
last year's estimate of 36.2  0.7 million birds and 3% 
below the 1955-2003 long-term average. Mallards (Anas platyrhynchos) 
numbered 7.4  0.3 million, similar to last year's estimate 
of 7.9  0.3 million birds and to the long-term average. 
Blue-winged teal (A. discors) numbered 4.1  0.2 million, 
26% below last year's estimate of 5.5  0.3 million, and 10% 
below the long-term average. Among other duck species, northern 
shovelers (A. clypeata, 2.8  0.2 million) and American 
wigeon (A. americana, 2.0  0.1 million) were both 22% below 
their 2003 estimates. As in 2003, gadwall (A. strepera, 2.6 < plus-
minus> 0.2 million, +56%), green winged teal (A. crecca, 2.5  0.1 million, +33%), and northern shovelers (+32%) were above 
their long-term averages. Northern pintails (A. acuta, 2.2  
0.2 million, -48%), scaup (Aythya affinis and A. marila, 3.8 < plus-
minus> 0.2 million, -27%), and American wigeon (-25%) were well below 
their long-term averages in 2004.
    Total May ponds in Prairie Canada and the north-central U.S. were 
3.9  0.2 million, or 24% lower than last year and 19% below 

the long-term average. The projected mallard fall flight (which is 
fundamental for setting waterfowl hunting regulations) was 9.4 < plus-
minus> 0.1 million birds, compared to the estimate of 10.3  
0.1 million in 2003.
    The 2004 total-duck population estimate for the eastern survey area 
(strata 51-56 and 62-69) was 3.9  0.3 million birds. This 
estimate was similar to last year's estimate of 3.6  0.3 
million birds and to the 1996-2003 average. Individual species 
estimates for this area were similar to 2003 estimates and to 1996-2003 
averages, with the exception of American wigeon (0.1  0.1 
million) and goldeneyes (Bucephala clangula and B. islandica, 0.4 
 0.1 million), which were 61% and 42% below their 1996-2003 
averages, respectively, and ring-necked ducks (Aythya collaris, 0.7 
 0.2 million), for which the estimate was up 67% from 2003.

Other Biota

    Waterfowl hunting occurs in habitats used by many taxa of migratory 
birds, as well as by aquatic invertebrates, amphibians, and some 
mammals. Fish also may be found in many hunting locations.

Shot Formulation and Production

    Iron-Tungsten-Nickel shot is an alloy of 62% iron, 25% tungsten, 
and 13% nickel. Its density is about 9 grams/cm\3\. The shot has no 
coating, nor is it chemically or physically altered when fired from a 
shotgun. Neither

[[Page 23956]]

manufacturing the shot nor firing shotshells containing the shot will 
alter the metals or increase their susceptibility to dissolving in the 
environment.
    ENVIRON-Metal estimates that the volume of ITN shot for use in 
hunting migratory birds in the United States will be approximately 
200,000 pounds (90,719 kilograms) during the first year of sale, and 
perhaps 500,000 pounds (227,000 kg) per year thereafter.

Environmental Fate of the Metals in ITN Shot

    Elemental tungsten and iron are virtually insoluble in water, and 
therefore 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 usually found at less than 1 part per billion (ppb) in 
fresh waters 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 (USEPA 1980). Water hardness is the dominant factor 
governing nickel effects on biota (Stokes 1988).

Possible 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 (50 CFR 20.134). For ITN shot, if the shot are completely 
dissolved in dry, porous soil, the EEC for iron is 14.55 g/m\3\, or 
11.19 parts per million (ppm). Iron is naturally widespread, comprising 
approximately 2% of the composition of soils and sediments in the U.S. 
The EEC for iron from ITN shot is much lower than that level.
    Tungsten is rare (1.5 ppm in the earth's crust), and is never found 
free in nature. The EEC for tungsten in soil is 5.92 g/m\3\, or 4.55 
ppm. This is below the EEC for several other tungsten-based shot types 
that we have previously approved. We are not aware of any problems 
associated with those shot types. The U.S. Environmental Protection 
Agency (USEPA) does not have a biosolids application limit for 
tungsten.
    The EEC for nickel in ITN shot in soils is 3.08 g/m\3\, or 4.55 
ppm. This concentration is far below the USEPA biosolids application 
limit of 420 ppm (USEPA 2000).
    The EEC for water assumes that 69,000 4 shot are 
completely dissolved in 1 hectare of water 1 foot (30.48 cm) deep. For 
ITN shot, the EEC for iron in water is 2.39 milligrams per liter (mg/
l). The USEPA chronic water quality criterion for iron in fresh water 
is 1 mg/l.
    The EEC for tungsten from ITN shot is 0.97 mg/l. The USEPA has set 
no acute or chronic criteria for tungsten in aquatic systems.
    The aquatic EEC for nickel from ITN shot is 505 mcg/l. The USEPA 
(1980) acute criterion for nickel in fresh water is 1400 mcg/l; the 
chronic criterion is 160 mcg/l. The acute and chronic criteria for salt 
water are 75 and 8.3 mcg/l, respectively.

Effects of Iron-Tungsten-Nickel Shot

    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).
    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. Tungsten powder added to 
the food of young rats at 2, 5, and 10% by mass for 70 days did not 
affect health or growth (Sax and Lewis 1989). A dietary concentration 
of 94 parts ppm did not reduce weight gain in growing rats (Wei et al. 
1987). Exposure to pure tungsten through oral, inhalation, or dermal 
pathways is not reported to cause any health effects (Sittig 1991).
    Tungsten salts are toxic to mammals. 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).
    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. They found that the shot neither 
produced toxic effects nor induced adverse systemic effects in the 
ducks during the 8-week period of their study.
    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 reduced xanthine oxidase activity and reduced growth of 
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. 1981). Ecological Planning and Toxicology (1999) concluded that 
the No Observed Adverse Effect Level for tungsten for chickens should 
be 250 ppm in the diet; the Lowest Observed Adverse Effect Level should 
be 500 ppm. Kelly et al. (1998) demonstrated no adverse effects on 
mallards dosed with tungsten-iron or tungsten-polymer shot according to 
nontoxic shot test protocols.
    Ringelman et al. (1993) conducted a 32-day acute toxicity study 
which involved dosing game-farm mallards with a shot alloy of 39% 
tungsten, 44.5% bismuth, and 16.5% tin (TBT shot) by weight, 
respectively. All the test birds survived, showed normal behavior, and 
suffered no tissue toxicity or damage. Kraabel et al. (1996) determined 
that imbedded tungsten-bismuth-tin shot neither produced toxic effects 
nor induced any adverse systemic effects on the health of ducks.
    Nickel is a dietary requirement of mammals, with necessary 
consumption set at 50 to 80 ppb 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).

[[Page 23957]]

    Soluble nickel salts are very toxic to mammals, with an oral 
LD50 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, but 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. Mallard ducklings fed 1,200 ppm nickel as nickel sulfate 
from one to 90 days of age experienced reduced growth rates, tremors, 
paresis, and death (71% within 60 days) (Cain and Pafford 1981). 
Weights of ducklings receiving 200 and 800 ppm nickel were not 
significantly different than controls, but the humerus weight/length 
ratio, a measure of bone density, was significantly lower than controls 
among females in the 800 ppm group and all birds in the 1,200 ppm 
group. There was no mortality in the 200 and 800 ppm groups. Assuming a 
mean daily consumption of 128 g per bird (Heinz 1979), the 800 ppm 
treatment group would have consumed 102 mg nickel each day and 9.2 g 
nickel during the course of the 90-day study. In a Tier 2 dosing study 
under the regulations governing approval of nontoxic shot, mallard 
ducks birds would each be given eight number 4 ITN shot (each 
containing 0.02206 g of nickel) during the study. A duck would be 
exposed to 0.176 g of nickel during the study if the nickel were 
completely dissolved. This is much less than the nickel exposure 
experienced by the mallards in the Eastin and O'Shea (1981) study.
    Toxicity of nickel to aquatic organisms is dependent upon water 
hardness, pH, and organic content, as well as other minor environmental 
parameters (Allen and Hansen 1996). In soft water, as few as 7 ppb may 
be acutely toxic to fish fry, but in harder waters toxicity thresholds 
may be an order of magnitude higher (Stokes 1988). General toxicity 
ranges for aquatic organisms are as variable, with an acute toxicity of 
as low as 82 mcg/l for some oligochaetes to 138,000 mcg/l for some 
gastropods; chronic toxicity values range from fewer than 100 mcg/l for 
some green algae to 10,000 mcg/l for filamentous algae (Stokes 1988).
    The freshwater criterion maximum concentration is dependent on 
hardness. For a water body with hardness of 50 mg/l (generally 
associated with highly oligotrophic systems that would not support 
large numbers of waterfowl), this results in a criterion of 1,400 mcg/
l. However, because early fish life stages are more sensitive to 
nickel, the freshwater chronic criterion is 160 mcg/l at a hardness of 
50 mg/l (USEPA 1986).
    The aquatic EEC for nickel from ITN shot is 505 mcg/l. The USEPA 
(1980) acute criterion for nickel in fresh water is 1400 mcg/l; the 
chronic criterion is 160 mcg/l. The acute and chronic criteria for salt 
water are 75 and 8.3 mcg/l, respectively. Based on the EEC, the maximum 
release of nickel from ITN shot would be well below the fresh water 
acute criterion for protection of aquatic life. The EEC exceeds the 
chronic criterion for fresh water and both acute and chronic values for 
seawater. However, ENVIRON-Metal reported that corrosion studies 
recently performed by an independent laboratory show that the corrosion 
rate for ITN shot is essentially equivalent to that of common steel, 
which is roughly linear with exposure time. Assuming that the rate of 
loss in the corrosion study continued, ITN shot would release about 11% 
of the calculated EEC per year; or about 4% of the acute water quality 
criterion and 35% of the chronic criterion for nickel in fresh water. 
After accounting for the dissolution of the shot, the EEC would be 
below the chronic criterion for salt water, but still about 7 times the 
acute criterion. However, the 11% dissolution would occur over a full 
year. Deposition of ITN shot in salt water environments would occur 
only during the hunting season, so worst-case nickel concentrations 
would be well below the chronic criterion. In addition, in most 
settings, shot deposition is far below that upon which the EEC is 
based.
    Based on the information provided about ITN shot provided to us, we 
have little concern for the organisms from ingestion of ITN shot or 
from dissolution of the shot in aquatic settings.
    We have previously approved as nontoxic other shot types that 
contain tungsten, iron, and nickel. Previous assessments of tungsten-
containing alloys indicated that neither the tungsten nor the iron in 
ITN shot should be of concern in terrestrial or aquatic systems. The 
release of iron from the shot would be insignificant in natural 
settings. Reviews of past studies for approvals of other tungsten-alloy 
nontoxic shot types also support the idea that ingestion of ITN shot 
will not cause harm to birds or mammals.

Impacts of Approval of ITN Shot as Nontoxic

    The status quo would be maintained by not authorizing use of ITN 
shot for hunting waterfowl and coots. By regulation, 10 other nontoxic 
shot types are authorized for use by waterfowl and coot hunters. 
Because these shot types are nontoxic to migratory birds, using only 
those shot types would have no adverse impact on waterfowl and their 
habitats.
    Based on past test results of shot types containing the metals in 
ITN shot, we believe it too is nontoxic to waterfowl, other biota, and 
their habitats. Furnishing another approved nontoxic shot will likely 
result in a minor positive long-term impact on waterfowl and wetland 
habitats. Approval of ITN shot as nontoxic would have a positive impact 
on the waterfowl resource.
    The impact on endangered and threatened species of approval of the 
shot will be small but positive. We obtain a biological opinion 
pursuant to Section 7 of the Endangered Species Act prior to 
establishing the seasonal hunting regulations. The hunting regulations 
promulgated as a result of this consultation remove and alleviate 
chances of conflict between migratory bird hunting and endangered and 
threatened species.
    Our consultations do not address take resulting from noncompliance. 
Indeed, a factor considered when we developed the regulations banning 
the use of lead for migratory waterfowl hunting was the impact of lead 
on endangered and threatened species. Hunter failures to comply with 
the ban on lead for waterfowl and coot hunting are of concern to us. We 
believe noncompliance is of some concern, but failure to approve ITN 
shot as nontoxic would have only a small negative impact on the 
resource.
    The impact of approval of ITN shot on endangered and threatened 
species is similar to that described for waterfowl. In the short- and 
long-term, approval would provide a positive impact on endangered and 
threatened species because all indications are that ITN shot is 
nontoxic. Also, as an alternative shot, it will further discourage the 
use of lead during waterfowl hunting and perhaps extend to upland game.
    Approval of ITN shot as nontoxic would have a short-term positive 
impact on ecosystems. Some hunters still

[[Page 23958]]

shooting lead shot might switch to ITN shot. Approval of an additional 
nontoxic shot type will result in positive long-term impact on 
ecosystems.

Cumulative Impacts

    We foresee no negative cumulative impacts of approval of ITN shot 
for waterfowl hunting. Approval of an additional nontoxic shot type 
should help to further reduce the negative impacts of the use of lead 
shot for hunting waterfowl and coots. We believe the impacts of 
approval of ITN shot for waterfowl hunting should be positive both in 
the United States and elsewhere.

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 preliminarily conclude that ITN 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 in December 1997 (62 FR 63608). 
International Nontoxic Composites, Inc. has documented that ITN shot 
meets this requirement.
    The third condition for approval involves enforcement. In 1995 (60 
FR 43314), 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. ITN shotshells can be drawn to a magnet as a simple 
field detection method.
    For these reasons, and in accordance with 50 CFR 20.134, we propose 
to approve Iron-Tungsten-Nickel shot as nontoxic for migratory bird 
hunting, and propose to amend 50 CFR 20.21(j) accordingly. This 
decision is based on data about the components of this shot, assessment 
of concentrations in aquatic settings, and assessment of the 
environmental effects of the shot. Those results indicate no likely 
deleterious effects of ITN shot to ecosystems or when ingested by 
waterfowl. Earlier testing of shot types containing tungsten and/or tin 
and/or iron indicated no environmental problems due to those metals in 
nontoxic shot. We do not believe the nickel in ITN shot will pose a 
significant environmental hazard, and we propose to approve ITN shot 
with no further testing.

References

Allen, H. E. and D. J. Hansen. 1996. The importance of trace metal 
speciation to water quality criteria. Water Environment Research. 
68:42-54.
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.
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.
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 Hevi-metalTM nontoxic shot: Tier 1 report. 
Cherry Hill, New Jersey.
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.
Heinz, G.H. 1979. Methylmercury: Reproductive and behavioral effects 
on three generations of mallard ducks. Journal of Wildlife 
Management 43:394-401.
Kabata-Pendias, A. and H. Pendias. 1984. Trace elements in soils and 
plants. CRC Press, Inc. Boca Raton, FL.
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. Ringleman. 
1996. Effects of embedded tungsten-bismuth-tin shot and steel shot 
on mallards. Journal of Wildlife Diseases 38:1-8.
McGhee, F., C. R. Greger, 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.
National Research Council. 1980. Mineral tolerance of domestic 
animals. National Research Council, National Academy of Sciences, 
Washington, DC.
Nell, J. A., W. L. Bryden, G. S. Heard, and D. Balnave. 1981. 
Reproductive performance of laying hens fed tungsten. Poultry 
Science 60:257-258.
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. 1952. 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.
Sax, N. I., and R. J. Lewis. 1989. Dangerous Properties of 
Industrial Materials. Seventh Edition, Volume II. Van Nostrand 
Reinhold, New York.
Schnegg, S. and M. Kirchgessner. 1976. [Toxicity of dietary nickel]. 
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effects of aluminum, barium, beryllium, and tungsten. Journal of 
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chicks. Journal of Nutrition 95:612-616.
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Chung Hua Chung Liu Tsa Chih 9:204-7. English abstract.

Public Comments Solicited

    Our past experience with nontoxic shot approvals has been that 30 
days is sufficient time for those interested in these actions to 
comment. Tungsten, iron, and nickel have been reviewed for use in 
nontoxic shot. Therefore, we will accept comments on this proposal for 
a 30-day period. A longer public comment period could unnecessarily 
delay approval of this shot for subsequent production and use.

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), though all of the metals in this shot type have been 
approved in higher concentrations in other shot types and are not 
likely to pose adverse toxicity effects on fish, wildlife, their 
habitats, or the human environment, we have prepared a Draft 
Environmental Assessment for this action. We will finalize the 
Environmental Assessment before we publish a final rule on this action.

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 concluded that because all of the 
metals in this shot type have been approved in higher concentrations in 
other shot types and should not be available to biota due to use of ITN 
shot, this action will not affect endangered or threatened species. A 
Section 7 consultation under the ESA for this rule is not needed.

Cumulative Impacts

    We foresee no negative cumulative impacts from approval of this 
additional nontoxic shot type. Approval of an additional shot type with 
metals already approved as nontoxic will not additionally impact the 
human environment.

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 proposes to approve an additional type of 
nontoxic shot that may be sold and used to hunt migratory birds; this 
rule would provide one shot type in addition to the types that are 
approved. We have determined, however, that 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. We anticipate no dislocation or 
other local effects, with regard to hunters and others.

Executive Order 12866

    This rule is not a significant regulatory action subject to Office 
of Management and Budget (OMB) review under Executive Order 12866. This 
rule will not have an annual economic effect of $100 million or more or 
adversely affect an economic sector, productivity, jobs, the 
environment, or other units of government. Therefore, a cost-benefit 
economic analysis is not required. This action will not create 
inconsistencies with other agencies' actions or otherwise interfere 
with an action taken or planned by another agency. No other Federal 
agency has any role in regulating nontoxic shot for migratory bird 
hunting. The action is consistent with the policies and guidelines of 
other Department of the Interior bureaus. This action will not 
materially affect entitlements, grants, user fees, loan programs, or 
the rights and obligations of their recipients because it has no 
mechanism to do so. This action will not raise novel legal or policy 
issues because the Service has already approved several other nontoxic 
shot types.
    OMB makes the final determination under E.O. 12866. 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? (A 
``section'' appears in bold type and is preceded by the symbol ``Sec.  
'' and a numbered heading; for example, ``Sec.  20.134 Approval of 
nontoxic shot types.'') (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. OMB has approved 
collection of information for the nontoxic shot approval process, and 
has assigned control number 1018-0067, which expires on December 31, 
2006, to collection of information shot manufacturers 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 
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.

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.

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

[[Page 23960]]

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 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.

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 I 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; 16 U.S.C. 742a-j; Pub. L. 106-108.

    2. Section 20.21 is amended by revising paragraph (j)(1) to read as 
follows:


Sec.  20.21  What hunting methods are illegal?

* * * * *
    (j)(1) While possessing loose shot for muzzle loading or shotshells 
containing other than the following approved shot types.

------------------------------------------------------------------------
           Approved shot type             Percent composition by weight
------------------------------------------------------------------------
bismuth-tin............................  97 bismuth, 3 tin.
iron (steel)...........................  iron and carbon.
iron-tungsten (2 types)................  60 iron, 40 tungsten and 78
                                          iron, 22 tungsten.
iron-tungsten-nickel...................  62 iron, 25 tungsten, 13
                                          nickel.
tungsten-bronze........................  51.1 tungsten, 44.4 copper, 3.9
                                          tin, 0.6 iron.
tungsten-matrix........................  95.9 tungsten, 4.1 polymer.
tungsten-nickel-iron...................  50 tungsten, 35 nickel, 15
                                          iron.
tungsten-polymer.......................  95.5 tungsten, 4.5 Nylon 6 or
                                          11.
tungsten-tin-bismuth...................  49-71 tungsten, 29-51 tin; 0.5-
                                          6.5 bismuth, 0.8 iron.
tungsten-tin-iron-nickel...............  65 tungsten, 21.8 tin, 10.4
                                          iron, 2.8 nickel.
------------------------------------------------------------------------

* * * * *

    Dated: February 1, 2005.
Craig Manson,
Assistant Secretary for Fish and Wildlife and Parks.
[FR Doc. 05-9022 Filed 5-5-05; 8:45 am]

BILLING CODE 4310-55-P