[Federal Register: August 24, 2005 (Volume 70, Number 163)]
[Proposed Rules]               
[Page 49541-49553]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24au05-20]                         

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

50 CFR Part 20

RIN 1018-AU04; 1018-AU 09; 1018-AU13; 1018-AU28

 
Migratory Bird Hunting; Approval of Tungsten-Iron-Copper-Nickel, 
Iron-Tungsten-Nickel Alloy, and Tungsten-Bronze (Additional 
Formulation), and Tungsten-Tin-Iron Shot Types as Nontoxic for Hunting 
Waterfowl and Coots; Availability of Environmental Assessments

AGENCY: Fish and Wildlife Service, Interior.

ACTION: Proposed rule; notice of availability.

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

SUMMARY: The U.S. Fish and Wildlife Service (we, us, or USFWS) proposes 
to approve four shot types or alloys for hunting waterfowl and coots 
and to change the listing of approved nontoxic shot types in 50 CFR 
20.21(j) to reflect the cumulative approvals of nontoxic shot types and 
alloys.
    These four shot types or alloys were submitted to us separately, 
and we published advance notices of proposed rulemakings for these shot 
types under RINs 1018-AU04, 1018-AU09, 1018-AU13, and 1018-AU28, 
respectively. We now combine all these actions under RIN 1018-AU04.
    In addition, we propose to approve alloys of several metals because 
we have approved the metals individually at or near 100% in nontoxic 
shot.

DATES: Send comments on this proposal by September 23, 2005.

ADDRESSES: You may submit comments, identified by RIN 1018-AU04, 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-AU04'' 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.
    For specific instructions on submitting or inspecting public 
comments, inspecting the complete file for this rule, or requesting a 
copy of the draft environmental assessment, see Public Comments in 
SUPPLEMENTARY INFORMATION.

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, amended), Mexico (1936, amended), Japan (1972, 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 applications for approval of four shot types as 
nontoxic for hunting waterfowl and coots. Those shot types are:
    1. Tungsten-Iron-Copper-Nickel (TICN) shot, of 40-76 percent 
tungsten, 10-37 percent iron, 9-16 percent copper, and 5-7 percent 
nickel (70 FR 3180, January 21, 2005);
    2. Iron-Tungsten-Nickel (ITN) alloys composed of 20-70 percent 
tungsten, 10-40 percent nickel, and 10-70 percent iron (70 FR 22625, 
May 2, 2005);
    3. Tungsten-Bronze (TB) shot made of 60 percent tungsten, 35.1 
percent copper, 3.9 percent tin, and 1 percent iron (70 FR 22624, May 
2, 2005, Note: This formulation differs from the Tungsten-Bronze 
nontoxic shot formulation approved in 2004.); and
    4. Tungsten-Tin-Iron (TTI) shot composed of 58 percent tungsten, 38 
percent tin, and 4 percent iron.
    The metals in these shot types have already been approved in other 
nontoxic shot types. In considering approval of these shot types, we 
were particularly concerned about the solubility and bioavailability of 
the nickel and copper in them. In addition, because tungsten, tin, and 
iron have already been approved at very high proportions of other 
nontoxic shot types with no known negative effects of the metals, we 
will propose approval of all alloys of these four metals.
    The data provided to us indicate that the shot types are nontoxic 
when ingested by waterfowl and should not pose a significant danger to 
migratory birds, other wildlife, or their habitats. We conclude that 
they raise no particular concerns about deposition in the environment 
or about ingestion by waterfowl or predators.
    The process for submission and evaluation of new shot types for 
approval as nontoxic is given at 50 CFR 20.134. The list of shot types 
approved as nontoxic for use in hunting migratory birds is provided in 
the table at 50 CFR 20.21(j). With this proposed rule, we also propose 
to revise the listing of approved nontoxic shot types in Sec.  20.21(j) 
to include the cumulative approvals of the shot types considered in 
this proposed rule with the other nontoxic shot types already in the 
table.
    Many hunters believe that some nontoxic shot types do not compare 
favorably to lead and that they may damage some shotgun barrels, and a 
small percentage of hunters have not complied with nontoxic shot 
regulations. Allowing use of additional nontoxic shot types may 
encourage greater hunter compliance and participation with nontoxic 
shot requirements and discourage the use of lead shot. The use of 
nontoxic shot for waterfowl hunting has increased in recent years 
(Anderson et al. 2000), but we believe that compliance will continue to 
increase with the availability and approval of other

[[Page 49542]]

nontoxic shot types. Increased use of nontoxic shot will enhance 
protection of migratory waterfowl and their habitats. More important, 
however, is that the Fish and Wildlife Service is obligated to consider 
all complete nontoxic shot submissions.
    We also propose to add a column to the table of approved shot types 
that lists the field testing device suitable for each shot type. The 
information in this column is strictly informational, not regulatory. 
Because these regulations are used by both waterfowl hunters and law 
enforcement officers, we believe that information on suitable testing 
devices is a useful addition to the table.

Affected Environment

Waterfowl Populations

    The taxonomic family Anatidae, principally subfamily Anatinae 
(ducks) and their habitats, comprise the affected environment. 
Waterfowl habitats and populations in North America in 2004 were 
described by the U.S. Fish and Wildlife Service (Garrettson et al. 
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  0.6 ( 1 standard error) 
million birds, 11 percent below the 2003 estimate of 36.2  
0.7 million birds, and 3 percent below the 1955-2003 long-term average. 
Mallards (Anas platyrhynchos) were estimated at 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 percent below last 
year's estimate of 5.5  0.3 million and 10 percent below 
the long-term average. Among other duck species, only northern 
shovelers (A. clypeata, 2.8  0.2 million) and American 
wigeon (A. americana, 2.0  0.1 million) were both 22 
percent below their 2003 estimates. As in 2003, gadwall (A. strepera, 
2.6  0.2 million, +56 percent), green-winged teal (A. 
crecca, 2.5  0.1 million, +33 percent), and northern 
shovelers (+32 percent) were above their long-term averages. Northern 
pintails (A. acuta, 2.2  0.2 million, -48 percent), scaup 
(Aythya affinis and A. marila, 3.8  0.2 million, -27 
percent), and American wigeon (-25 percent) were well below their long-
term averages in 2004.

Habitats

    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. In 2004, 
total May ponds in Prairie Canada, and the north-central United States 
combined were estimated at 3.9  0.2 million, which was 24 
percent lower than the figure for 2003 and 19 percent below the long-
term average. Pond numbers in both Canada (2.5  0.1 
million) and the U. S. (1.4  0.1 million) were below 2003 
estimates (-29 percent in Canada, and -16 percent in the United 
States), and pond numbers in Canada were 25 percent below the long-term 
average for the region.

Fall Flight Forecasts

    The projected mallard fall flight index was 9.4  0.1 
million birds, similar to the 2003 estimate of 10.3  0.1 
million. 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 the 2003 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 percent and 42 percent below 
their 1996-2003 averages, respectively, and ring-necked ducks (Aythya 
collaris, 0.7  0.2 million), which increased by 67 percent 
relative to the 2003 estimate of their numbers.

Characterization of the Four Shot Types

TICN Alloys

    Spherical Precision, Inc. of Tustin, CA, submitted Tungsten-Iron-
Copper-Nickel (TICN) shot for approval. The advance notice of proposed 
rulemaking for this group of alloys was published in the Federal 
Register on January 21, 2005, under RIN 1018-AU04 (70 FR 3180). This is 
an array of layered alloys or metals of 40-76 percent tungsten, 10-37 
percent iron, 9-16 percent copper, and 5-7 percent nickel. TICN shot 
has a density ranging from 10.0 to 14.0 grams per cubic centimeter (g/
cm3), is noncorrosive, and is magnetic. Spherical Precision 
estimates that the volume of TICN shot for use in hunting migratory 
birds in the United States will be approximately 50,000 pounds (lb) 
(22,700 kilograms (kg)) during the first year of sale, and perhaps 
100,000 lb (45,400 kg) per year thereafter.

ITN Alloys

    ENVIRON-Metal of Sweet Home, OR, submitted Iron-Tungsten-Nickel 
(ITN) alloys, which are cast alloys containing 10-70 percent iron, 20-
70 percent tungsten, and 10-40 percent nickel. The advance notice of 
proposed rulemaking for this group of alloys published in the Federal 
Register on May 2, 2005, under RIN 1018-AU09 (70 FR 22625). The 
proposed shot types have densities ranging from about 8.5 to about 13.5 
g/cm3. The compositions of the alloys are shown in table 1.

                                                        Table 1.--Composition of ITN Shot Alloys
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Iron                    Tungsten                   Nickel
                                                  Density  (g/ Shot weight -----------------------------------------------------------------------------
                      Alloy                        cm\3\) \1\    (mg) \2\                   Weight                    Weight                    Weight
                                                                              Percent        (mg)       Percent        (mg)       Percent        (mg)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1...............................................          8.8       165.89           70       116.12           20        33.18           10        16.59
2...............................................          9.0       169.65           40        67.86           20        67.86           40        33.93
3...............................................          9.8       184.73           44        81.28           33        60.96           23        42.49
4...............................................         11.3       213.00           10        21.30           50       106.50           40        85.20
5...............................................         13.3       250.71           20        50.14           70       175.49           10        25.07
6...............................................        13.55       255.42           10        25.54           70       178.79           20       51.08
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note.--Weights are based on one number 4 shot.

    ENVIRON-Metal estimated that the yearly volume of ITN shot types 
with densities between those of steel (7.86 g/cm3) and lead 
(11.3 g/cm3) expected for use in hunting migratory birds in 
the United States is approximately 200,000 lb (113,500 kg) during the 
first year of sale. In the second year and beyond, sales upwards of 
500,000 lb (227,000 kg) per year are anticipated. ITN shot types with 
densities greater than that of lead may ultimately attain sales levels 
of 1,000,000 lb (454,000 kg) per year.

[[Page 49543]]

TB Shot

    The Olin Corporation of East Alton, IL, submitted Tungsten-Bronze 
(TB) shot for approval. The advance notice of proposed rulemaking for 
this shot type was published in the Federal Register on May 2, 2005, 
under RIN 1018-AU13 (70 FR 22624). This is a sintered composite with an 
average composition of 60 percent tungsten, 35.1 percent copper, 3.9 
percent tin, and 1 percent iron. The copper and tin make up 39 percent 
of the shot as a 90:10 ratio, respectively, in the form of a bronze 
alloy. The shot has a density of 12.0 g/cm3, compared to 
11.1-11.3 g/cm3 for lead, and 7.9 g/cm3 for 
steel. Olin estimated that the yearly volume of the TB shot in hunting 
migratory birds in North America will be approximately 300,000 lb 
(136,200 kg).

TTI Shot

    Tungsten-Tin-Iron (TTI) shot, submitted by Nice Shot, Inc., of 
Albion, PA, is a cast alloy composed of 58 percent tungsten, 38 percent 
tin, and 4 percent iron. This shot type has a density of 11.0 g/
cm3. Nice Shot, Inc. estimated that approximately 5,000 lb 
(2,270 kg) of TTI shot are expected to be sold for use in hunting 
migratory birds in the United States during the first year of sale. TTI 
shot contains less than 1 percent lead, and will not be coated.
    Each of the four shot types has a residual lead level of less than 
1 percent. To inhibit corrosion, TICN shot may be coated with tin, and 
ITN shot may be surface-coated with thin petroleum-based films. Neither 
TB nor TTI shot will be coated.

Environmental Fate of the Metals in the Four Shot Types

    All of the metals in these shot types have been approved in other 
nontoxic shot types, and the submitters asserted that the four shot 
types pose no adverse toxicological risks to waterfowl or other forms 
of terrestrial or aquatic life. Our particular concern in considering 
approval of these shot types is the solubility and bioavailability of 
the nickel and copper in them.
    The metals in the four shot types are insoluble under hot and cold 
(Weast 1986). Neither manufacturing the shot nor firing shotshells 
containing the shot will alter the metals or change how they dissolve 
in the environment. The shot types are not chemically or physically 
altered by firing from a shotgun.
    Iron is naturally widespread. It comprises approximately 2 percent 
of the composition of soils and sediments in the United States. The 
iron in the shot types is not soluble.
    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).
    Elemental copper can be oxidized by organic and mineral acids that 
contain an oxidizing agent. Elemental copper is not oxidized in water 
(Aaseth and Norseth 1986).
    Nickel is common in fresh waters, though usually at concentrations 
of less than 1 part per billion (p/b) in locations unaffected by human 
activities. Pure nickel is not soluble in water, and resists corrosion 
at temperatures between -20 [deg]C and 30 [deg]C (Chau and Kulikovsky-
Cordeiro 1995). Free nickel may be part of chemical reactions, such as 
sorption, precipitation, and complexation. ``Under anaerobic 
conditions, typical of deep groundwater, precipitation of nickel 
sulfide keeps nickel concentrations low'' (Eisler 1998). Reactions of 
nickel with anions are unlikely. Complexation with organic agents is 
poorly understood (U.S. Environmental Protection Agency [EPA] 1986). 
Water hardness is the dominant factor governing nickel effects on biota 
(Stokes 1988).
    Tin is only very slightly soluble at pH values from 4 to 11, as 
found in natural settings. Tin occurs naturally in soils at 2 to 200 
mg/g (parts per thousand or ppt) with areas of enrichment at 
concentrations up to 1,000 mg/g (WHO 1980). In general, however, soil 
concentrations in the United States are between 1 and 5 parts per 
million (p/m) (Kabata-Pendias and Pendias 1984).

Possible Environmental Concentrations for Metals in the Four Shot Types 
in Terrestrial Systems

    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). These calculations assume that the shot 
dissolves promptly and completely after deposition.

TICN Alloys

    The maximum EEC for TICN shot for tungsten in soil is 21.3 p/m. 
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. EPA does not have a 
biosolids application limit for tungsten.
    For TICN shot, if the shot are completely dissolved in dry, porous 
soil, the maximum EEC for iron is 7.40 p/m. Iron is naturally 
widespread, comprising approximately 2 percent of the composition of 
soils and sediments in the United States. The EEC for iron from TICN 
shot is much lower than that level.
    For copper in TICN shot, the maximum EEC in soils is 3.36 p/m. In 
comparison, the ceiling concentration limit for biosolids application 
for copper is 4,300 p/m (EPA 2000).
    The maximum EEC for nickel in TICN shot in soils is 1.62 p/m. This 
concentration is a small fraction of the EPA biosolids application 
limit of 420 p/m (EPA 2000).
    If TICN shot is coated with tin, the EEC for tin in dry soils is 
1.31 p/m. There is no EPA biosolids application limit for tin, but it 
occurs naturally in soils at 2 to 200 p/m, with areas of enrichment at 
concentrations up to 1,000 p/m (WHO 1980). In general, soil 
concentrations in the United States are between 1 and 5 p/m; the 
suggested maximum concentration in surface soil tolerated by plants is 
50 p/m dry weight (Kabata-Pendias and Pendias 1984).

ITN Alloys

    The terrestrial EECs for the iron and tungsten from any ITN alloy 
(table 2) are below those from approved shot types, and we do not 
believe they are a problem in soils. Though data on iron concentrations 
in biosolids are unavailable, natural soil background concentrations 
range from 5,000 to 50,000 p/m. This is equivalent to 32,500 to 325,000 
kg per hectare (kg/h). We do not believe that the worst-case additional 
8.01 kg of iron per hectare (about 0.025 percent of natural background 
concentrations) would have any effect on plants or animals, especially 
since the iron in the shot is not in a soluble form.

[[Page 49544]]



                                 Table 2.--Expected Terrestrial Environmental Concentrations of the Metals in ITN Alloys
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Deposition (kg)                     Terrestrial EEC (p/m)
                       Alloy  (% I/T/N)                        Shot weight -----------------------------------------------------------------------------
                                                                   (kg)         Iron       Tungsten      Nickel        Iron       Tungsten      Nickel
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 (70/20/10).................................................       11.446         8.01         2.29         1.15        12.33         3.52         1.76
2 (40/20/40).................................................       11.706         4.68         2.34         4.68         7.20         3.60         7.20
3 (44/33/23).................................................       12.746         5.61         4.21         2.93         8.63         6.47         4.51
4 (10/50/40).................................................       14.700         1.47         7.35         5.88         2.26        11.31         9.05
5 (20/70/10).................................................       17.299         3.46        12.11         1.73         5.32        18.63         2.66
6 (10/70/20).................................................       17.624         1.76        12.34         3.52         2.71        18.98         5.42
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Data from biosolid studies indicate that tungsten generally is 
present at 40 to 180 p/m, about four times the worst EEC for tungsten 
from ITN shot. Therefore, it is unlikely that tungsten from the shot 
would exceed concentrations obtained from biosolid applications.
    The estimated soil concentration (p/m soil) of nickel for ITN alloy 
4 (the highest in nickel) is a very small fraction of the 420 p/m 
maximum concentration allowed for terrestrial application of biosolids 
and is two orders of magnitude less than the maximum cumulative loading 
rate for nickel of 420 kg/h per year (http://www.epa.gov/cgi-bin/claritgw
). We do not believe that nickel from ITN shot would pose an 

environmental problem in soils.

TB Shot

    Based on the maximum concentration of each metal in any formulation 
of TB shot, the increased concentrations in soils for the metals are 
14.4 p/m for tungsten, 8.43 p/m for copper, 0.94 p/m for tin, and 0.24 
p/m for iron. The EEC for tungsten is lower than the value for ITN 
shot, and considerably lower than the values for previously approved 
shot types. As noted earlier, the ceiling concentration limit for 
biosolids application for copper is 4,300 p/m (EPA 2000). The EEC for 
iron from TB shot is extremely small.

TTI Shot

    The EEC for tungsten in TTI shot in soil (the increase in soil 
concentration) is 12.77 mg/kg or p/m. 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 EPA 
does not have a biosolids application limit for tungsten. Data from 
biosolid studies indicate that tungsten generally is present at 40 to 
180 p/m, about four times the worst EEC for tungsten from ITN shot. 
Therefore, it is unlikely that tungsten from the shot would exceed 
concentrations obtained from biosolid applications.
    The EEC for tin in dry soils is 8.37 p/m. In general, soil 
concentrations in the United States are between 1 and 5 p/m; the 
suggested maximum concentration in surface soil tolerated by plants is 
50 p/m dry weight (Kabata-Pendias and Pendias 1984), about six times 
the worst-case concentration to be expected from TTI shot.
    If the shot are completely dissolved in dry, porous soil, the 
maximum EEC for iron is 0.88 p/m. Iron is naturally widespread, 
comprising approximately 2 percent of the composition of soils and 
sediments in the United States. The EEC for iron from TTI shot is much 
lower than that level.
    Though data on iron concentrations in biosolids are unavailable, 
natural soil background concentrations range from 5,000 to 50,000 p/m. 
This is equivalent to 32,500 to 325,000 kg per hectare. We do not 
believe that the extremely small addition of the insoluble iron from 
TTI shot would have any effect on plants or animals, especially because 
the iron in the shot is not in a soluble form.

Possible Environmental Concentrations for Metals in the Four Shot Types 
in Aquatic Systems

    The EEC for water assumes that 69,000 number 4 shot are completely 
dissolved in 1 hectare of water 1 foot (ft) (30.48 cm) deep. The 
submitter then calculates the concentration of each metal in the shot 
if the shot pellets dissolve completely. For our analyses, we assume 
complete dissolution of the shot type containing the highest proportion 
of each metal in the range of alloys submitted.

TICN Alloys

    For TICN shot, the EEC for tungsten is 4.541 milligrams per liter 
(mg/l). The EPA has set no acute or chronic criteria for tungsten in 
aquatic systems.
    The EEC for iron from TICN shot in water is 1.579 mg/l. The chronic 
water quality criterion for iron in fresh water is 1 mg/l (EPA 1986). 
EPA has no criterion for salt water.
    For copper, the aquatic EEC is 0.717 mg/l. This value is above both 
the acute and chronic criteria for freshwater and saltwater. This issue 
is discussed in the ``In Vitro Solubility Evaluation of TICN Shot'' 
section.
    The aquatic EEC for nickel from TICN shot is 0.346 mg/l. The EPA 
(1986) acute criterion for nickel in fresh water is 1,400 micrograms 
per liter ([mu]g/l); the chronic criterion is 160 [mu]g/l. The acute 
and chronic criteria for salt water are 75 and 8.3 [mu]g/l, 
respectively. Based on the EEC, the maximum release of nickel from TICN 
shot would be well below the fresh water acute criterion for protection 
of aquatic life.
    For the tin in TICN shot, the aquatic EEC is 0.280 mg/l. The lowest 
published standard for tin in water is the 4 mg/l water quality 
standard for the state of Minnesota. Even in the worst case, the tin 
concentration from dissolved TICN shot would be well below this 
standard.

ITN Alloys

    The aquatic EECs for the metals in ITN shot are shown in table 3. 
The EEC for nickel exceeds aquatic water quality criteria (table 4). 
However, corrosion studies demonstrated that corrosion rates for all 
types of ITN shot are relatively low in both fresh water and seawater. 
This corrosion is discussed under ``In Vitro Solubility Evaluation of 
ITN Shot.''

[[Page 49545]]



                                   Table 3.--Expected Aquatic Environmental Concentrations of the Metals in ITN Alloys
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Deposition (kg)                       Aquatic EEC (p/m)
                       Alloy  (% I/T/N)                        Shot weight -----------------------------------------------------------------------------
                                                                   (kg)         Iron       Tungsten      Nickel        Iron       Tungsten      Nickel
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 (70/20/10).................................................       11.446         8.01         2.29         1.15        2,629          751          376
2 (40/20/40).................................................       11.706         4.68         2.34         4.68        1,536          768        1,536
3 (44/33/23).................................................       12.746         5.61         4.21         2.93        1,840        1,380          962
4 (10/50/40).................................................       14.700         1.47         7.35         5.88          482        2,411        1,929
5 (20/70/10).................................................       17.299         3.46        12.11         1.73        1,135        3,973          568
6 (10/70/20).................................................       17.624         1.76        12.34         3.52          578        4,048        1,156
--------------------------------------------------------------------------------------------------------------------------------------------------------


               Table 4.--Aquatic Life Criteria and Worst-Case Concentrations of Metals in ITN Shot
----------------------------------------------------------------------------------------------------------------
                                     Acute water quality   Chronic water quality
               Metal                criterion for aquatic  criterion for aquatic    Maximum EEC from ITN alloys
                                       life  ([mu]g/l)        life  ([mu]g/l)
----------------------------------------------------------------------------------------------------------------
Iron..............................  No Criterion.........  1,000................  2,629 (Alloy 1).
Tungsten..........................  No Criterion.........  No Criterion.........  4,048 (Alloy 6).
Nickel (fresh water)..............  1,400................  160..................  1,929 (Alloy 4).
Nickel (salt water)...............  75...................  8.3..................  1,929 (Alloy 4).
----------------------------------------------------------------------------------------------------------------

TB Shot

    The aquatic EECs for metals in TB shot are shown in table 5. The 
EEC for copper is considerably above the criteria for protection of 
fresh water and salt water life. However, a solubility study for this 
shot type demonstrated that corrosion of TB shot is low. This is 
discussed under ``In Vitro Solubility Evaluation of TB Shot.''

                     Table 5.--Aquatic Life Criteria and Concentrations of Metals in TB Shot
----------------------------------------------------------------------------------------------------------------
                                              Acute water quality        Chronic water quality
                  Metal                   criterion for aquatic life  criterion for aquatic life    Maximum EEC
                                                   ([mu]g/l)                   ([mu]g/l)           from TB shot
----------------------------------------------------------------------------------------------------------------
Tungsten................................  No Criterion..............  No Criterion..............           3,073
Copper (Fresh Water)....................  13.0......................  9.0.......................           1,797
Copper (Salt Water).....................  4.8.......................  3.1.......................           1,797
Tin.....................................  4,0001 \1\................  No Criterion..............           199.7
Iron....................................  No Criterion..............  1,000.....................           51.2
----------------------------------------------------------------------------------------------------------------
\1\ Minnesota water quality standard, no federal standard for comparison.

TTI Shot

    The EEC for tungsten is 2.72 milligrams per liter (mg/1). The EPA 
has set no acute or chronic criteria for tungsten in aquatic systems.
    The aquatic EEC for tin is 1.78 mg/1. The lowest published standard 
for tin in water is the 4 mg/1 water quality standard for the state of 
Minnesota. Tin concentration from dissolved TTI shot would be well 
below this standard.
    The EEC for iron from TTI shot in water is 0.19 mg/1. The chronic 
water quality criterion for iron in fresh water is 1 mg/1 (EPA 1986). 
EPA has no criterion for salt water.

In Vitro Solubility Evaluation of TICN Shot

    When nontoxic shot is ingested by waterfowl, both physical breakup 
of the shot, and dissolution of the metals that comprise the shot, may 
occur in the highly acidic environment of the gizzard. In addition to 
the standard Tier 1 application information, Spherical Precision 
provided the results of an in vitro gizzard simulation test conducted 
to quantify the release of metals in solution under the prevailing pH 
conditions of the avian gizzard. The metal concentrations released 
during the simulation test were, in turn, compared to known levels of 
metals that cause toxicity in waterfowl. The evaluation followed the 
methodology of Kimball and Munir (1971) as closely as possible. The 
average amount of copper and nickel released from eight TICN shot per 
day are 1.87 mg and 1.77 mg, respectively.
    The maximum tolerable level of dietary copper during the long-term 
growth of chickens (Gallus domesticus) and turkeys (Meleagris species) 
has been reported to be 300 p/b (Committee on Mineral Toxicity in 
Animals (CMTA) 1980). At the maximum tolerable level for chronic 
exposure of 300 ppb for poultry, a 1.8 kg chicken consuming 100 g of 
food per day (Morck and Austic 1981) would consume 30 mg copper per day 
(16.7 mg of copper per kg of body weight per day). The average amount 
of copper released from eight TICN shot is 1.87 mg per day, which is 
well below concentrations that cause copper toxicosis in waterfowl. A 
bird would have to ingest 129 TICN shot to exceed the maximum tolerable 
level.
    No reproductive or other effects were observed in mallards that 
consumed the equivalent of 102 mg of nickel as nickel sulfate each day 
for 90 days (Eastin and O'Shea 1981). Therefore, the average amount of 
nickel released from eight TICN shot/day of 1.77 mg will pose no risk 
of adverse effects to waterfowl. Additionally, metallic nickel likely 
has a lower absorption from the gastrointestinal tract than does the 
nickel sulfate used in the mallard reproduction study, further 
decreasing the absorbed dose of TICN shot compared to the published 
toxicity study described above.
    We concluded that TICN shot is very resistant to degradation, and 
that it poses no risk to waterfowl if ingested in the field. The slow 
breakdown rate of

[[Page 49546]]

1.53 mg per shot per day only permits the release of 0.233 mg of copper 
and 0.221 mg of nickel per shot per day, both of which are 
concentrations that are orders of magnitude below toxic levels of 
concern for copper and nickel in waterfowl.

In Vitro Solubility Evaluation of ITN Shot

    Fresh water, seawater, and an ``artificial gizzard'' environment 
(Kimball and Munir, 1971) were evaluated to determine their corrosion 
rates on each of the six alloys, plus steel as a standard. The 
``artificial gizzard'' test, although developed for lead alloy 
evaluation, proved to reliably simulate the mallard gizzard for both 
steel and ITN alloys and constitutes a very conservative approach for 
evaluation of nontoxic shot. This test resulted in corrosion/erosion 
rates up to twice those measured in steel and Tungsten-Nickel-Iron 
mallard in-vivo studies (January 4, 2001, 66 FR 737).
    The ITN alloys with relatively low concentrations of tungsten and 
nickel corrode in a manner similar to that of steels. Corrosion rates 
of such steels are roughly linear over a wide range of exposure time. 
This corrosion is in contrast with that of alloys such as stainless 
steel, tungsten-nickel iron, or ``high-alloy'' varieties of ITN, which 
readily form passivating oxide layers that impede further corrosion. 
Assuming that the short-term rate of shot weight loss would continue 
for one month in a static aqueous environment (a conservative 
assumption, because natural fresh water and seawater environments are 
dynamic, and because corrosion products forming on metal surfaces tend 
to progressively retard corrosion rates), the actual EECs are presented 
in table 6. These data show that the nickel concentration from ITN shot 
actually will be well below both the acute and chronic criteria for 
nickel in aquatic settings.

            Table 6.--Environmental Concentrations of Metals in ITN Shot Based on Solubility Testing
----------------------------------------------------------------------------------------------------------------
                                                   Fresh Water EEC ([mu]g/l)         Salt Water EEC ([mu]g/l)
               Alloy  (% I/T/N)                -----------------------------------------------------------------
                                                   Iron     Tungsten    Nickel      Iron     Tungsten    Nickel
----------------------------------------------------------------------------------------------------------------
1 (70/20/10)..................................      27.16       7.76       3.87       3.36       0.97       0.23
2 (40/20/40)..................................       1.95       0.97       1.95          0          0          0
3 (44/33/23)..................................      12.61       9.69       6.70      10.66       7.99       2.60
4 (10/50/40)..................................       1.45       7.27       5.82          0          0          0
5 (20/70/10)..................................       6.79      23.77       3.40       2.72      20.37       2.90
6 (10/70/20)..................................          0          0          0          0          0          0
----------------------------------------------------------------------------------------------------------------

    ENVIRON-Metal also provided the results of an in-vitro gizzard 
simulation test conducted to quantify the release of metals in solution 
under the prevailing pH conditions of the avian gizzard (table 7). 
These data also demonstrate that the hazards from these alloys to 
wildlife would be very minimal.

                Table 7.--Metal Loss From ITN Alloys in a Simulated Gizzard Over a 14-Day Period.
----------------------------------------------------------------------------------------------------------------
                                                   Initial               Weight Loss (mg)
                                                  weight of  ---------------------------------------   Percent
                Alloy  (% I/T/N)                  10  number                                         weight loss
                                                 4 shot  (g)      Iron       Tungsten      Nickel
----------------------------------------------------------------------------------------------------------------
1 (70/20/10)...................................        1.994       179.90        51.40        25.70         12.9
2 (40/20/40)...................................        2.687        64.00        32.00        64.00          5.9
3 (44/33/23)...................................        2.766        72.60        54.45        37.95          5.9
4 (10/50/40)...................................        3.479        13.10        65.50        52.40          3.7
5 (20/70/10)...................................        3.462        18.80        65.80         9.40          2.7
6 (10/70/20)...................................        3.418        19.40       135.80         38.8          5.7
----------------------------------------------------------------------------------------------------------------

In Vitro Solubility Evaluation of TB Shot

    The EEC for copper EEC was over 138 times the freshwater acute 
criterion of 13 g/l, and 200 times the freshwater chronic criterion of 
9.0 g/l. However, Olin noted that the very conservative assumptions 
used to calculate the copper EEC are only an indication of the likely 
effect of deposition of TB shot in an aquatic setting. Therefore, as an 
addendum to the application for TB shot, Olin had an in-vitro 
dissolution test in water conducted. The test was conducted to quantify 
the release of metals from TB shot at pH values of 5.6, 6.6, and 7.6 in 
synthetic buffered waters. The highest EEC for copper from the 
dissolution evaluations was 0.15 [mu]g/l at pH 5.6. The hardness-
adjusted chronic water quality criterion for copper was 9.7 [mu]g/l, 
approximately 65 times the worst-case EEC. Therefore, detrimental 
effects in aquatic systems from dissolution of TB shot would be highly 
unlikely.
    Olin provided the results of an in-vitro gizzard simulation test 
conducted to quantify the release of metals in solution under the 
prevailing pH conditions of the avian gizzard. The simulation test 
demonstrated that a number 4 TB shot would release about 0.67 mg of the 
alloy per day. This, in turn, would mean release of approximately 0.24 
mg of copper per day.
    Olin pointed out that the theoretical availability of copper from 
this in-vitro gizzard simulation test should be considered maximal when 
compared to the Irby et al. (1967) study results or the CMTA (1980) 
guideline. Unlike the in-vivo gizzard, which resembles an open 
corrosion system in which the products of the corrosion process are 
constantly being eliminated (Kimball and Munir 1971), the test design 

for this in-vitro gizzard simulation was a closed corrosion system. 
Therefore, fine pieces of shot that would be released, and normally 
discarded from the gizzard, remained in the dissolution medium and 
potentially yielded more copper. Additionally, the analytical samples 
were analyzed for total metals with no

[[Page 49547]]

filtration or centrifugation prior to analysis. As a result, the fine 
pieces of shot that were not fully dissolved and would normally be 
excreted were included in the total copper concentrations reported.

Summary: Solubility Evaluations

    We have previously approved as nontoxic other shot types that 
contain tungsten, iron, and tin. Previous assessments of nontoxic shot 
types indicated that the potential release of iron, tungsten, or tin 
from TICN, ITN, or TB shot should not harm aquatic or terrestrial 
systems and we believe the small amount of tin in TB shot is not likely 
to harm waterfowl. The solubility testing further indicates that the 
release of nickel from ITN shot and copper from TICN or TB shot is not 
sufficient to present a hazard to aquatic systems or to biota. We 
propose to approve the four shot types as nontoxic. Our approval is 
based on the toxicological report, acute toxicity studies, 
reproductive/chronic toxicity studies, and other published research. 
The available information indicates that the four shot types are 
nontoxic when ingested by waterfowl and that they pose no significant 
danger to migratory birds, other wildlife, or their habitats.

Impacts of Approval of the Four Shot Types

Effects of the Metals

Iron
    Iron is an essential nutrient. Iron toxicosis in mammals is 
primarily a phenomenon of overdosing of livestock. Maximum recommended 
dietary levels of iron range from 500 p/m for sheep to 3000 p/m for 
pigs (National Research Council [NRC] 1980). The amount of iron in any 
of the four shot types would not pose a hazard to mammals.
    Chickens require at least 55 p/m iron in the diet (Morck and Austic 
1981). There were no ill effects on chickens fed 1,600 p/m iron in an 
adequate diet (McGhee et al. 1965), and chicks tolerated 1,600 p/m iron 
in the diets that included adequate copper, although decreased weight 
gains and increased mortality were observed in copper-deficient diets 
(McGhee et al. 1965). At the maximum tolerable level for chronic 
exposure of 1,000 p/m for poultry (NRC 1980), a 1.8 kg chicken 
consuming 100 grams of food per day (Morck and Austic 1981) would 
consume 100 mg iron per day (56 mg per kg of body weight per day).
    Deobald and Elvehjem (1935) reported that 4,500 p/m iron in the 
diet produced rickets in chicks. Adverse effects were not observed when 
turkey poults were fed diets amended with 440 p/m iron (Woerpel and 
Balloun 1964).
    Turkey poults fed 440 p/m in the diet suffered no adverse effects. 
The tests, in which eight number 4 tungsten-iron shot were administered 
to each mallard in a toxicity study indicated that the 45 percent iron 
content of the shot had no adverse effects on the test animals (Kelly 
et al. 1998).
    We are not aware of acute toxicity data for iron in waterfowl. 
Zinc-coated iron shot appeared to have little or no effect on ducks 
dosed with eight number 6 shot; mortality and weight loss for treated 
ducks were comparable to those for control animals (Irby et al. 1967).
    Game-farm mallards administered eight number 4 pellets of tungsten-
iron shot, indicated no adverse effects from either the tungsten or the 
iron (Kelly et al. 1998). This shot formulation has a much greater iron 
content (45 percent) than do the shot types considered here.
Tungsten
    Tungsten salts are toxic to mammals. Lifetime exposure to 5 p/m 
tungsten as sodium tungstate in drinking water produced no discernible 
adverse effects in rats (Rattus species) (Schroeder and Mitchener 
1975). However, with 100 p/m tungsten as sodium tungstate in drinking 
water, rats had decreased enzyme activity after 21 days (Cohen et al. 
1973).
    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 percent by mass for 70 days did 
not affect health or growth (Sax and Lewis 1989). A dietary 
concentration of 94 p/m 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).
    Acute tungsten toxicosis results in death from respiratory 
paralysis, often preceded by diarrhea and coma. Chronic intoxication is 
most evident in reduced growth rates. However, the most sensitive sign 
is reduced xanthine oxidase activity. Xanthine oxidase is an enzyme 
that is dependent upon molybdenum for proper functioning. It is thought 
that tungsten readily substitutes for molybdenum, with subsequent 
reduction in enzyme activity; supplemental dietary molybdenum will 
reverse the symptoms. The National Research Council Committee on Animal 
Nutrition recommends a maximum tolerable dose of 20 p/m tungsten in the 
diet for effective rearing of livestock (NRC 1980).
    The LD50 of tungsten as sodium tungstate 
(Na2WO4) administered by intraperitoneal 
injection is 112 p/b body weight in male rats and 79 p/b body weight in 
mice (Mus species) (Pham-Huu-Chanh 1965). This would classify tungsten 
as ``very toxic'' when administered intraperitoneally as a soluble 
salt. Kinard and Van de Erve (1941) showed that 
Na2WO4 is the most toxic tungsten salt, when 
compared with tungsten oxide and ammonium paratungstate.
    Tungsten administered in the diet had no effects on rats until 
reaching 150 p/m diet when carcinoma incidence was increased in female 
Sprague-Dawley rats (Wei et al. 1987). Higgins et al. (1956a, b) noted 
that dietary concentrations of 45 or 94 p/m tungsten produced no 
adverse effects on weight gain in growing rats. Other studies with rats 
indicate that dietary exposure to 5,000 p/m tungsten oxide 
(WO3) or Na2WO4 results in 90 percent 
and 80 percent mortality, respectively, by the 70th day of exposure 
(NRC 1980). However, lifetime exposure of rats to 5 p/m tungsten as 
Na2WO4 in drinking water resulted in no 
observable adverse effects (Schroeder and Michener 1975). At 100 p/m 
tungsten as Na2WO4 in drinking water, rats had 
decreased enzyme activity after 21 days of exposure (Cohen et al. 
1973).
    Goats (Capra hircus) appear to be less tolerant of dietary 
tungsten. A 5-month exposure to 22.5 p/m dietary tungsten as 
Na2WO4 resulted in depressed liver xanthine 
oxidase activity in growing kids. Milk production in goats and cows 
(Bos species) was unaffected by a single oral exposure to 25.0 p/b body 
weight of Na2WO4 (Owen and Proudfoot 1968). Anke 
and Groppel (1985) established that goats require at least 0.06 p/m 
tungsten in their diets for optimal reproduction.
    Chickens given a complete diet showed no adverse effects of 250 p/m 
sodium tungstate administered for 10 days in the diet. However, 500 p/m 
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 p/m tungsten (Nell 
et al. 1981). Ecological Planning and Toxicology (1999) concluded that 
the No Observed

[[Page 49548]]

Adverse Effect Level for tungsten for chickens should be 250 p/m in the 
diet; the Lowest Observed Adverse Effect Level should be 500 p/m. Kelly 
et al. (1998) demonstrated no adverse effects on mallards dosed with 
tungsten-iron or tungsten-polymer shot according to nontoxic shot test 
protocols.
    Breeder hen exposure to 250 p/m tungsten as sodium tungstate for 10 
days had no adverse effects, but increasing the diet to 500 p/m 
tungsten for an additional 20 days resulted in decreased xanthine 
oxidase activity (Teekell and Watts 1959). Similarly, day-old chicks on 
a 500 p/m tungsten diet with adequate molybdenum showed reduced rate of 
gain (Selle 1942).
    Nell et al. (1981) fed laying hens diets containing 1,000 p/m 
tungsten (unspecified salt) for five months; control diets contained 
0.4 p/m tungsten. Hens were artificially inseminated and eggs were 
collected and set weekly. Three of 40 hens on the high-tungsten diet 
died, and the remaining 37 had reduced egg production and egg weight. 
Egg fertility and hatchability were not affected. Liver tungsten was 
significantly elevated in treated birds, although there was no effect 
on body weight.
    Day-old white leghorn chickens placed on a molybdenum-deficient 
diet for 35 days showed a decreased rate of growth and increased 
mortality at 45 p/m tungsten as sodium tungstate (Higgins et al. 1956a, 
b). However, this is not an accurate reflection of tungsten toxicity 
because low molybdenum levels potentiate the effects of tungsten (NRC 
1980).
    Ecological Planning and Toxicology (1999) concluded that the No 
Observed Adverse Effect Level (NOAEL) for tungsten for chickens should 
be 250 p/m in the diet; the Lowest Observed Adverse Effect Level should 
be 500 p/m. An adult chicken fed a diet of 1,000 p/m tungsten for 150 
days would ingest about 100 mg of tungsten per day, or a total of 15 
grams. In the USFWS guidelines for a reproduction study for shot, 
mallards would receive eight number 4 shot on four dosing periods. A 
total of 32 TICN shot during the course of the study, each containing 
0.2006 grams of tungsten, would result in a total exposure of 6.42 
grams of tungsten, if the tungsten in the shot is totally dissolved. 
This estimated exposure of 6.42 grams of tungsten during a TICN shot 
mallard reproductive study is about 43 percent of the 15 grams 
demonstrated to cause reproductive effects in chickens.
    The effects of ingestion of tungsten by mallards as elemental metal 
in a shot pellet were studied by Ringelman et al. (1993). Birds were 
given pellets of 39 percent tungsten, 44.5 percent bismuth, and 16.5 
percent tin by weight, per bird. No evidence of toxicity or other 
histological changes were reported. Tungsten was not detected in liver 
or kidney tissue.
    Dosing mallards with eight number 4 Iron-Tungsten shot (with 55 
percent tungsten) also produced no tungsten toxicity in the ducks 
(Kelly et al. 1998). In that study, birds received eight number 4 
pellets by oral gavage and were observed for changes in serum enzymes, 
organ weights, histology of tissues and accumulation of metals in bone. 
Tungsten was detected in femur, liver, and kidneys of dosed ducks, but 
no other significant changes were measured. Iron-Tungsten shot eroded 
by 55 percent and Tungsten-Polymer shot eroded by 80 percent over the 
course of the study; however, tissue concentrations were lower in the 
Tungsten-Polymer birds than in the Iron-Tungsten group. The shot were 
55 percent tungsten for the Iron-Tungsten formulation and 95.5 percent 
tungsten for the polymerized shot. The amount of tungsten in TICN shot 
(40-76 percent) is similar to that in the Iron-Tungsten shot (55 
percent). Tungsten-Nickel-Iron shot in the study by Ecotoxicology & 
Biosystems Associates, Inc. (2000), conducted with a proportion of 
tungsten similar to that in TICN shot, was not toxic.
    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 shot produced no toxic 
effects nor induced adverse systemic effects during the 8-week study.
Copper
    Copper is a dietary essential for all living organisms. In most 
mammals, ingestion of one TICN shot pellet would result in release of 8 
to 25 mg of copper, not all of which would be absorbed. In humans, 
ingestion of a pellet could mobilize approximately 8 mg of copper. 
These low levels of copper would not pose any risk to mammals.
    Copper requirements in birds may vary depending on intake and 
storage of other minerals (Underwood 1971). The maximum tolerable level 
of dietary copper during the long-term growth of chickens and turkeys 
is 300 p/m (CMTA 1980). Eight-day-old ducklings were fed a diet 
supplemented with 100 p/m copper as copper sulfate for eight weeks. 
They showed greater growth than controls, but some thinning of the 
caecal walls (King 1975). Studying day-old chicks, Poupoulis and Jensen 
(1976) reported that no gizzard lining erosion could be detected in 
chicks fed 125 p/m of copper for four weeks, but they detected slight 
gizzard erosion in chicks fed 250 p/m copper. The authors found that it 
required 500 to 1,000 p/m of copper to depress growth and weight gain 
of chicks. Jensen et al. (1991) found that 169 p/m copper in the diet 
produced maximal weight gain in chickens.
    Stevenson and Jackson (1979) studied the influence of dietary 
copper addition on the body mass and reproduction of mature domestic 
chickens. Hens fed on a diet containing 250 p/m copper for 48 days 
showed a similar rate of food intake as control hens that had no copper 
in their diet. Additionally, the mean number of eggs laid daily did not 
differ between hens fed 250 p/m copper and the controls. After 4 months 
of being fed at dietary copper levels in excess of 500 p/m, negative 
effects on the daily food intake, body mass loss, and egg-laying rates 
were observed.
    At the 300 p/m level for chronic exposure for poultry, a 1.8 kg 
chicken consuming 100 g of food per day (Morck and Austic 1981) would 
consume 30 mg of copper per day (16.7 mg of copper per kg of body 
weight/day). One number 4 TICN shot contains a maximum of 31.7 mg of 
copper. However, at the 0.233 mg of copper per shot per day release 
rate from the solubility testing, a bird would have to ingest at least 
128 TICN shot to exceed the maximum tolerable level. Thus, the copper 
release from the TICN shot appears to be well below the level that 
could cause copper toxicosis in waterfowl. The average amount of copper 
released from 8 TB nontoxic shot per day is 7.87 mg, so a bird would 
have to ingest over 30 shot to exceed the maximum tolerable level.
    Day-old poults fed diets containing 500 p/m ration for 24 weeks 
showed reduced growth and increased gizzard histopathology (Kashani et 
al. 1986). Growing domestic turkeys showed no long-term effects when 
fed 300 p/m copper in the daily diet, but 800 p/m of copper in the diet 
for 3 weeks inhibited growth with no adverse effects on survival 
(Supplee 1964). No effect of feeding 400 p/m of copper as copper 
sulfate to turkey poults in the daily diet for 21 weeks was reported, 
and it was concluded that poults could tolerate 676 p/m of copper 
without deleterious effects. Growth was reduced in poults fed 800 p/m 
and 910 p/m of copper over the same time (Vohra and Kratzer 1968). 
Their conclusion was supported by another study that found that copper 
in the diet of domestic turkeys had to rise to 500 to 750 p/m level 
before signs of slight toxicity appeared, assuming that

[[Page 49549]]

adequate methionine also was present (Christmas and Harms 1979).
    Henderson and Winterfield (1975) reported acute copper toxicity in 
3-week-old Canada geese (Branta canadensis) that had ingested water 
contaminated with copper sulfate. The authors calculated the copper 
intake to be about 600 mg copper sulfate/kg body weight, or 239 mg 
copper/kg. The amount of copper released from eight number 4 shot would 
be 42.26 mg, which is much less that the 239 p/b toxic level.
    Irby et al. (1967) dosed 24 Mallard ducks with 8 number 6 pure 
copper shot to observe if they were toxic over a 60-day exposure 
period. They calculated that the total mass of copper in the gizzard 
was 0.6 gram, and observed that none of the ducks died from copper 
toxicosis after 60 days. TB shot is 35.1 percent copper by weight, so 
eight shot would contain 0.64 grams of copper.
    International Nontoxic Composites, Inc. (2003) reported that pure 
copper control shot breaks down at the rate of 18.42 mg copper per gram 
of shot per day, or 11.05 mg copper per day for 0.6 grams of copper 
shot, under in vitro gizzard simulation test conditions. However, TB 
shot releases only 4.35 mg copper per gram of shot per day or 7.87 mg 
of copper per day for 1.81 grams of shot under the same test 
conditions. This indicates that TB shot should not be a hazard for 
wildlife that consume it.
    The EPA (2002) provided both acute and chronic freshwater quality 
criteria for copper, which are functions of water hardness. The 
freshwater acute criterion for a water body with hardness of 100 mg/l, 
for example, is 13 [mu]g/l, and the chronic criterion is 9.0 [mu]g 
copper per liter. The EPA acute and chronic saltwater quality criteria 
are not affected by hardness, and are 4.8 and 3.1 [mu]g/l.
Nickel
    Deficiencies have been reported in diets ranging from 2 to 40 
billion p/b nickel (NRC 1980). The dietary requirement for nickel has 
been set at 50 to 80 p/b for the rat and chick (Nielsen and Sandstead 
1974). Humans consume up to 900 [mu]g per day as a normal dietary 
intake (Nieboer et al. 1988). Though it is necessary for some enzymes, 
nickel competes with zinc, calcium, and magnesium for binding sites on 
most of the metal-dependent enzymes, resulting in various levels of 
inactivation, although it is essential for functioning of some enzymes, 
particularly urease (Andrews et al. 1988, Nieboer et al. 1988). Water-
soluble nickel salts are poorly absorbed from the gastrointestinal 
tract, averaging only 3 percent to 6 percent assimilation efficiency in 
rats (Nieboer et al. 1988).
    Rats fed nickel carbonate concentrations up to 1,000 p/m for 3 to 4 
months did not show treatment-related effects, nor was body weight of 
pups affected (Phatak and Patwardhan 1950). Elevated nickel 
concentrations in pups were observed in the 500 and 1,000 p/m treatment 
groups. Young rats were fed nickel catalyst (finely divided nickel 
suspended in vegetable oil and supported on kieselguhr) at 250 p/m for 
16 months with no effects (Phatak and Patwardhan 1952).
    Rats fed 1,000 p/m nickel sulfate for 2 years exhibited mild 
effects, such as reduced body weight and liver weight, but increased 
heart weight (Ambrose et al. 1976). Also, there was an increase in the 
number of stillborn pups and a decrease in weanling weights through 
three generations. Nickel chloride was most toxic to rats. Young rats 
decreased food consumption and lost body weight within 13 days in diets 
containing 1,000 p/m nickel as nickel chloride (Schnegg and 
Kirchgessner 1976).
    Calves showed weight loss and decreased feed intake, organ size, 
and nitrogen retention when fed 1,000 p/m nickel and nickel carbonate 
for 8 weeks (O'Dell et al. 1970a, 1971). Calves fed 250 p/m nickel did 
not show effects. Lactating dairy cows were not affected by 50 or 250 
p/m dietary nickel (Archibald 1949, O'Dell et al. 1970b). Soluble 
nickel salts are very toxic to mammals, with an oral LD50 of 136 p/b in 
mice, and 350 p/b in rats (Fairchild et al. 1977). Nickel catalyst 
(finely divided nickel in vegetable oil) fed to young rats at 250 p/m 
for 16 months, however, produced no detrimental effects (Phatak and 
Patwardhan 1952).
    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 p/m for 3 to 4 months (Phatak and Patwardhan 1952). Rats 
fed 1,000 p/m 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 p/m fed to young rats caused 
weight loss in 13 days (Schnegg and Kirchgestiner 1976).
    In chicks from hatching to 4 weeks of age, 300 p/m nickel as nickel 
carbonate or nickel acetate in the diet produced no observed adverse 
effects, but concentrations of 500 p/m or more reduced growth (Weber 
and Reid 1968). A diet containing 200 p/m nickel as nickel sulfate had 
no observed effects on mallard ducklings from 1 to 90 days of age. 
Diets of 800 p/m or more caused significant changes in physical 
condition of the ducklings (Cain and Pafford 1981).
    Mallard ducklings fed 1,200 p/m nickel as nickel sulfate from 1 to 
90 days of age experienced reduced growth rates, tremors, paresis, and 
death (71 percent within 60 days) (Cain and Pafford 1981). Weights of 
ducklings receiving 200 and 800 p/m 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 p/m group and all birds in the 1,200 p/m group. There was no 
mortality in the 200 and 800 p/m groups.
    Breeding pairs of mallards were fed diets containing 0, 12.5, 50, 
200, and 800 p/m nickel as nickel sulfate for 90 days (Eastin and 
O'Shea 1981). No treatment-related effects were observed on egg 
production, hatchability, or survival of ducklings. At the end of the 
90-day treatment period, there were no significant differences in 
hematocrit, concentrations of hemoglobin, plasma triglycerides, 
cholesterol, or plasma activities of ornithine carbamoyl transferase 
and alanine aminotransferase. The only treatment-related observation 
was a black, tarry feces in the 800 p/m group. Assuming a mean daily 
consumption of 128 grams per bird (Heinz 1979), the 800 p/m treatment 
group would have consumed 102 mg nickel each day and 9.2 grams of 
nickel during the course of the 90-day study. In the nontoxic shot Tier 
2 approval process, birds could be given eight number 4 shot. For ITN 
shot, each shot would contain 0.02206 grams of nickel, so each duck 
would receive 0.176 grams of nickel, assuming complete solubilization 
of the nickel from the shot during the study. This is a very small 
fraction of the 9.2 grams of total nickel exposure or 102 mg per day 
experienced by the mallards in the Eastin and O'Shea (1981) study. 
Therefore, we expect no effect of the nickel on birds ingesting the 
shot.
    No reproductive or other effects were observed in mallards 
consuming the equivalent of 102 mg of nickel as nickel sulfate each day 
for 90 days (Eastin and O'Shea 1981). Therefore, the 15.3 mg of nickel 
in each TICN shot, if completely eroded and absorbed in 24 hours, would 
not be expected to affect waterfowl. Based on the 0.221 mg of nickel 
per shot per day rate of release from the solubility study, a mallard 
would have to ingest in excess of 450 TICN shot to exceed the 102 mg 
nickel amount. Additionally, metallic nickel likely has a lower 
absorption from the

[[Page 49550]]

gastrointestinal tract than does the nickel sulfate used in the mallard 
reproduction study, further decreasing the absorbed dose of TICN shot 
compared to the published toxicity study described above.
    Adult mallards dosed with eight tungsten-nickel-iron number 4 
pellets were fed a whole kernel corn and grit and observed for signs of 
toxicity for 30 days following dosing (January 4, 2001; 66 FR 737). No 
adverse effects were observed on body weight, food consumption or 
clinical chemistry, hematology, and histopathology. The tungsten-
nickel-iron pellets lost an average of 7.9 percent of their initial 
weight during the study, releasing nickel at a rate of 1.85 mg per day 
per bird, for a total of 55.5 mg over the 30-day study.
    In a Tier 2 dosing study under the regulations governing approval 
of nontoxic shot, mallard ducks would each be given eight number 4 TICN 
shot (each containing 0.02206 grams of nickel) during the study. A duck 
would be exposed to 0.176 grams 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. We conclude that the nickel in TICN shot will not be significant 
to waterfowl that ingest the shot.
    Water hardness is the dominant factor governing nickel effects on 
aquatic biota (Stokes 1988). 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 little as 7 p/b nickel may be acutely toxic to fish fry, 
while in harder waters toxicity thresholds may be an order of magnitude 
higher (Stokes 1988).
    The EPA (1986) acute water quality criteria reflect this 
insensitivity of aquatic organisms to nickel. For a water body with 
hardness of 50 mg/l (generally associated with highly oligotrophic 
systems that would not support large numbers of waterfowl), the 
criterion is 1,400 [mu]g/l. However, early fish life stages are more 
sensitive to nickel (Stokes 1988), which is reflected in the order of 
magnitude lower Freshwater Chronic Criterion of 160 [mu]g/l at a 
hardness of 50 mg/l (EPA 1986).
    The saltwater chronic criterion of 8.3 [mu]g/l is much lower than 
the measured mysid shrimp (Mysidopsis bahia) chronic value, which is 
from the only chronic saltwater study in the EPA guidelines (EPA 1986).
    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 p/b may 
be acutely toxic to fish fry, but in harder waters toxicity thresholds 
may be an order of magnitude higher. General toxicity ranges for 
aquatic organisms are as variable, with an acute toxicity of as low as 
82 [mu]g/l for some oligochaetes to 138,000 [mu]g/l for some 
gastropods; chronic toxicity values range from fewer than 100 [mu]g/l 
for some green algae to 10,000 [mu]g/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 
[mu]g/l. However, because early fish life stages are more sensitive to 
nickel, the freshwater chronic criterion is 160 [mu]g/l at a hardness 
of 50 mg/l (EPA 1986).
Tin
    It is generally agreed that inorganic tin and tin compounds are 
comparatively harmless (Eisler 1989). Inorganic tin and its salts are 
poorly absorbed, their oxides are relatively insoluble, and they are 
rapidly lost from tissues (see Eisler 1989 for reviews). Reviews 
indicate that elemental tin is not toxic to birds (Cooney 1988, 
Eisler1989). Tin shot designed for waterfowl hunting is used in several 
European countries. We are aware of no reports that suggest that tin 
shot causes toxicity problems for wildlife.
    Tin (II) chloride was toxic to juvenile eels at 6.0 mg/l and 1.2 
mg/l, with death coming at 2.8 and 50 hours, respectively. This 
inorganic tin salt was also toxic to daphnids, at concentrations of 2.5 
mg/l or more. Metelev et al. (1971) found that 1 g/l of Tin (II) 
chloride dihydrate (530 mg of tin per liter) was lethal to all fish 
species tested (Bandman 1993).
    Grandy et al. (1968) and the Huntingdon Research Centre (1987) 
conducted 30-day and 28-day, respectively, acute toxicity tests on 
mallard ducks by placing tin pellets inside the digestive tract or 
tissues of ducks. They reported that all treated ducks survived without 
deleterious effects.
    Ringelmann et al. (1993) examined the effects of Tungsten-Bismuth-
Tin shot consumption in ducks. The authors found no signs of toxicosis, 
and tin was not detected in the liver or kidney (< 6 p/m) during the 32-
day test period. In a 30-day dosing study of game-farm mallards dosed 
with eight number 4 size tin shot, there were no overt signs of 
toxicity or treatment-related effects on body weight. Tin was not 
detected in any tissues (Gallagher et al. 1999).
    The 2 percent tin in bismuth-tin shot produced no toxicological 
effects in ducks during reproduction. It did not affect the health of 
ducks, the reproduction by male and female birds, or the survival of 
ducklings over the long term (Sanderson et al. 1997).
    Chronic and acute studies documenting the nontoxic properties of 
99.9 percent tin shot were conducted for the application for USFWS 
approval of tin shot as a nontoxic alternative. A 150-day chronic 
toxicity/reproductive study conducted for tin shot revealed no adverse 
effects in mallards dosed with eight number 4 sized shot. Additionally, 
there were no significant changes in egg production, fertility, or 
hatchability of birds dosed with tin when compared to steel-dosed 
birds. A 30-day acute study was also completed by the International Tin 
Research Institute (Federal Register 64:17308, 1999). Treatment 
mallards were dosed with eight number 4 tin shot and hematocrit and 
hemoglobin concentrations, body weight and indications of toxicity were 
compared to those of control (no shot) and steel shot-dosed birds. No 
adverse effects were seen in ducks dosed with tin. Hematocrit and 
hemoglobin concentrations did not differ from those of either negative 
control group, nor were there treatment-related effects on body weight. 
Ducks dosed with tin exhibited no sign of toxicity.
    In a study by Kraabel et al. (1996), shot pellets containing 39 
percent tungsten, 44.5 percent bismuth, and 16.5 percent tin were 
embedded into the breast muscle of mallards. There were no adverse 
systemic effects observed in the study and the localized inflammatory 
reactions surrounding the shot were reduced in the tin-containing shot 
when compared to the steel shot control group.
    Based on the toxicological report and toxicity tests, we concluded 
that shot that was 99.9 percent tin posed no significant danger to 
migratory birds or other wildlife and their habitats (65 FR 76886, 
December 7, 2000). Temporary approval was given because field detection 
techniques had not been approved, not due to any toxicity concerns. In 
support of the nontoxic application, chronic and acute toxicity tests 
demonstrated no adverse effects of tin shot on mallards. We do not 
believe the tin in any of the proposed shot types that contain it will 
pose toxicological risks due to wildlife.

[[Page 49551]]

Impacts of Approval of Alloys of Previously Approved Metals

    We propose to extend the past approvals of some nontoxic shot types 
to broader alloys. We have, for example, approved nontoxic shot of 
almost 100 percent tungsten, and steel shot is essentially 100 percent 
iron. We are not aware of any synergistic effects of these metals, and 
approval of other shot types containing them in different proportions 
has indicated that negative effects on wildlife, fish, or their 
habitats from approval of alloys of these metals are very unlikely. 
Therefore, we propose to approve alloys containing any proportion of 
tungsten and 1 percent or more iron.
    Similarly, as noted above, we gave temporary approval to shot of 
100 percent tin (65 FR 76885), though the submitter did not seek final 
approval of that shot type. We also propose to approve shot alloys with 
any proportions of tungsten and tin and at least 1 percent iron.

Effects of the Approvals on Migratory Waterfowl

    Approving additional nontoxic shot types will likely result in a 
minor positive long-term impact on waterfowl and wetland habitats. 
Approval of the four shot types and additional alloys as nontoxic would 
have a positive impact on the waterfowl resource.

Effects on Endangered and Threatened Species

    The impact on endangered and threatened species of approval of the 
four shot types and the additional alloys would be very small, but 
positive. The metals in all four shot types and the additional alloys 
have been approved in other nontoxic shot types, and we see no 
potential effects on threatened or endangered species due to approval 
of these shot types.

Effects on Ecosystems

    Previously approved shot types have been shown in test results to 
be nontoxic to the migratory bird resource, and we believe that they 
cause no adverse impact on ecosystems. There is concern, however, about 
noncompliance and potential ecosystem effects. The use of lead shot has 
a negative impact on wetland ecosystems due to the erosion of shot, 
causing sediment/soil and water contamination and the direct ingestion 
of shot by aquatic and predatory animals. Though we believe 
noncompliance is of concern, approval of the four shot types and the 
additional alloys will have little impact on the resource.

Cumulative Impacts

    We foresee no negative cumulative impacts of approval of the four 
shot types and the additional alloys for waterfowl hunting. Their 
approval should help to further reduce the negative impacts of the use 
of lead shot for hunting waterfowl and coots.

Literature Cited

    For a complete list of the literature cited in this proposed rule, 
contact the person listed under FOR FURTHER INFORMATION CONTACT.

Public Comments

    In accordance with the Administrative Procedures Act and our 
nontoxic shot approval regulations, we seek comments on this proposal. 
Of particular relevance is information regarding the potential impacts 
of these shot types and the approval of alloys of metals already 
approved in other formulations on migratory birds, other wildlife, and 
their habitats.
    In addition, Executive Order 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? (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?
    You may submit written comments on this proposal to the location 
identified in the ADDRESSES section, or you may submit electronic 
comments to the internet address or the e-mail address listed in the 
ADDRESSES section. We must receive your comments before the date listed 
in the DATES section. While our normal practice is to open public 
comment periods on our proposed rules for 60 days, in this case we are 
opening the comment period for only 30 days. We believe a 30-day 
comment period will be sufficient because we have approved several 
other nontoxic shot types through the rulemaking process and have 
received very few comments on those rulemaking actions and because the 
changes in this proposed rule should not be controversial. Following 
review and consideration of comments, we will issue a final rule on the 
proposed regulation changes.
    When submitting electronic comments, please include your name and 
return address in your message, identify it as comments on the nontoxic 
shot proposed rule, and submit your comments as an ASCII file, 
preferably as part of the e-mail text. Include RIN 1018-AU04 in the 
subject line of your message. Do not use special characters or any 
encryption. Written comments on this proposed rule must be on 8\1/2\-
inch by 11-inch paper.
    We make comments, including names and home addresses of 
respondents, available for public review during regular business hours. 
Individual respondents may request that we withhold their home address 
from the rulemaking record, which we will honor to the extent allowable 
by law. In some circumstances, we would withhold from the rulemaking 
record a respondent's identity, as allowable by law. If you wish us to 
withhold your name or address, you must state this prominently at the 
beginning of your comment. We will not accept anonymous comments. We 
will make all submissions from organizations or businesses, and from 
individuals identifying themselves as representatives or officials of 
organizations or businesses, available for public inspection in their 
entirety. Comments will become part of the Administrative Record for 
the review of the application. You may inspect comments at the mailing 
address in ADDRESSES during normal business hours.
    The Draft Environmental Assessment (DEA) for approval of the four 
shot types is available from the Division of Migratory Bird Management, 
U.S. Fish and Wildlife Service, 4501 North Fairfax Drive, Room 4091, 
Arlington, VA 22203-1610. You may call 703-358-1825 to request a copy 
of the DEA.
    The complete file for this rule is available, by appointment, 
during normal business hours at the same address. You may make an 
appointment at 703-358-1825 to review the files.

Required Determinations

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 regulations for implementing NEPA 
(40 CFR 1500-

[[Page 49552]]

1508), though all of the metals in these shot types have been approved 
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 Draft Environmental Assessments for this action. We will 
finalize the Environmental Assessments 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 these shot types have been approved in other shot types and 
will not be available to biota in significant amounts due to use of any 
of the four shot types, this action will not affect endangered or 
threatened species.

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.

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 economic impact on a substantial number of small 
entities, which include small businesses, organizations, or 
governmental jurisdictions. This rule proposes to approve four 
additional types of nontoxic shot that may be sold and used to hunt 
migratory birds. We have determined, however, that this rule will have 
no effect on small entities since the approved shot merely will 
supplement nontoxic shot types 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.

Small Business Regulatory Enforcement Fairness Act

    This proposed rule is not a major rule under 5 U.S.C. 804(2), the 
Small Business Regulatory Enforcement Fairness Act. This rule will not 
have an annual effect on the economy of $100 million or more; will not 
cause a major increase in costs or prices for consumers, individual 
industries, Federal, State, or local government agencies, or geographic 
regions; and 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.

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 new information collection requirements. OMB has assigned 
control number 1018-0067 to the collection of information that shot 
manufacturers are required to provide to us for the nontoxic shot 
approval process. This approval expires December 31, 2006. 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 
significantly or uniquely affect small governments or produce a Federal 
mandate of $100 million or more in any given year. Therefore, this rule 
does not constitute a significant regulatory action under the Unfunded 
Mandates Reform Act.

Civil Justice Reform--Executive Order 12988

    In promulgating this rule, we have determined that these 
regulations meet the applicable standards provided in Sections 3(a) and 
3(b)(2) of Executive Order 12988.

Takings

    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. A takings assessment is not required.

Federalism Effects

    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. In 
accordance with Executive Order 13132, this regulation does not have 
significant federalism effects, nor does it 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 proposed to be 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.

[[Page 49553]]



------------------------------------------------------------------------
                                        Percent
       Approved shot type           composition by       Field testing
                                        weight              device
------------------------------------------------------------------------
bismuth-tin.....................  97 bismuth, 3 tin.  Hot Shot[supreg]*.
iron (steel)....................  iron and carbon...  Magnet or Hot
                                                       Shot[supreg].
iron-tungsten...................  any proportion of   Magnet or Hot
                                   tungsten, >= 1      Shot[supreg].
                                   iron.
iron-tungsten-nickel............  >= 1 iron, any      Magnet or Hot
                                   proportion of       Shot[supreg].
                                   tungsten, up to
                                   40 nickel
tungsten-bronze.................  51.1 tungsten,      Rare Earth Magnet.
                                   44.4 copper, 3.9
                                   tin, 0.6 iron and
                                   60 tungsten, 35.1
                                   copper, 3.9 tin,
                                   1 iron.
tungsten-iron-copper-nickel.....  40-76 tungsten, 10- Hot Shot[supreg]
                                   37 iron, 9-16       or Rare Earth
                                   copper, 5-7         Magnet.
                                   nickel
tungsten-matrix.................  95.9 tungsten, 4.1  Hot Shot[supreg].
                                   polymer.
tungsten-polymer................  95.5 tungsten, 4.5  Hot Shot[supreg].
                                   Nylon 6 or 11.
tungsten-tin-iron...............  any proportions of  Magnet or Hot
                                   tungsten and tin,   Shot[supreg].
                                   >= 1 iron.
tungsten-tin-bismuth............  49-71 tungsten, 29- Rare Earth Magnet.
                                   51 tin; 0.5-6.5
                                   bismuth, 0.8
                                   iron.
tungsten-tin-iron-nickel........  65 tungsten, 21.8   Magnet.
                                   tin, 10.4 iron,
                                   2.8 nickel.
------------------------------------------------------------------------
* The information in the ``Field Testing Device'' column is strictly
  informational, not regulatory.
** The ``Hot Shot'' field testing device is from Stream Systems of
  Concord, CA.

* * * * *

    Dated: July 26, 2005.
Craig Manson,
Assistant Secretary for Fish and Wildlife and Parks.
[FR Doc. 05-16718 Filed 8-23-05; 8:45 am]

BILLING CODE 4310-55-P