[Federal Register Volume 64, Number 160 (Thursday, August 19, 1999)]
[Rules and Regulations]
[Pages 45400-45405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21525]
[[Page 45399]]
_______________________________________________________________________
Part VI
Department of the Interior
_______________________________________________________________________
Fish and Wildlife Service
_______________________________________________________________________
50 CFR Part 20
Migratory Bird Hunting; Final Approval of Tungsten-Iron and Tungsten-
Polymer Shots and Temporary Approval of Tungsten-Matrix and Tin Shots
as Nontoxic for Hunting Waterfowl and Coots; Final Rule
Federal Register / Vol. 64, No. 160 / Thursday, August 19, 1999 /
Rules and Regulations
[[Page 45400]]
DEPARTMENT OF INTERIOR
Fish and Wildlife Service
50 CFR Part 20
RIN 1018-AF65
Migratory Bird Hunting; Final Approval of Tungsten-Iron and
Tungsten-Polymer Shots and Temporary Approval of Tungsten-Matrix and
Tin Shots as Nontoxic for Hunting Waterfowl and Coots
AGENCY: Fish and Wildlife Service, Interior.
ACTION: Final rule.
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SUMMARY: The U.S. Fish and Wildlife Service (Service or we) amends
Section 20.21(j) to grant final approval of tungsten-iron and tungsten-
polymer shots as nontoxic for hunting waterfowl and coots. We also
grant temporary approval of tungsten-matrix and tin shots as nontoxic
for hunting waterfowl and coots during the 1999-2000 hunting season
only. Acute toxicity studies reveal no adverse effects over a 30-day
period on mallards (Anas platyrhynchos) dosed with either tungsten-
iron, tungsten-polymer, tungsten-matrix, or tin shot. Reproductive/
chronic toxicity testing over a 150-day period indicated that tungsten-
iron and tungsten-polymer administered to adult mallards did not
adversely affect them or the offspring they produced. We will not
consider final approval of tungsten-matrix and tin shots until all
required reproductive/chronic toxicity tests are successfully completed
and the results are received and approved by the Director. Tungsten-
iron and tungsten-polymer shots are produced by Federal Cartridge
Company (Federal) of Anoka, Minnesota. Tungsten-matrix shot is produced
by Kent Cartridge Company (Kent) of Kearneysville, West Virginia. Tin
shot is produced by the International Tin Research Institute (ITRI) of
Uxbridge, Middlesex, Great Britain.
DATES: This rule takes effect immediately upon publication on August
19, 1999.
ADDRESSES: Copies of the Environmental Assessments are available by
writing to the Chief, Office of Migratory Bird Management (MBMO), U.S.
Fish and Wildlife Service, 4401 N. Fairfax Dr., Suite 634, Arlington,
VA 22203.
FOR FURTHER INFORMATION CONTACT: Jon Andrew, Chief, Office of Migratory
Bird Management, (703) 358-1714.
SUPPLEMENTARY INFORMATION: Since the mid-1970s, we have sought to
identify shot that does not pose a significant toxic hazard to
migratory birds or other wildlife. Currently, only steel and bismuth-
tin shot are approved as nontoxic. We previously granted temporary
approval for tungsten-iron shot during the 1997-98 (August 13, 1997; 62
FR 43444) and 1998-99 (October 7, 1998; 63 FR 54016) migratory bird
hunting seasons. We also granted temporary approval for tungsten-
polymer (October 7, 1998; 63 FR 54022) and tungsten-matrix (December 8,
1998; 63 FR 67619) shots during the 1998-99 migratory bird hunting
season. Compliance with the use of nontoxic shot has increased over the
last few years. We believe that compliance will continue to increase
with the approval and availability of other nontoxic shot types.
Federal Cartridge Company's (Federal) tungsten-iron shot is an
alloy of approximately 40 percent tungsten and 60 percent iron, by
weight, and has a density of approximately 10.3 g/cm\3\. Tungsten-
polymer shot is a matrix of Nylon 6 or 11 polymer surrounding particles
of elemental tungsten. Shot made from this material has a density of
approximately 11.2 g/cm\3\ or approximately the density of lead. The
shot will contain approximately 95.5 percent tungsten and 4.5 percent
Nylon 6 or 11 by weight).
Kent's original candidate shot was fabricated from what is
described in their application as a mixture of powdered metals in a
plastic matrix whose density is comparable to that of lead. All
component metals are present as elements, not compounds. The tungsten-
matrix material from which pellets are formulated has a specific
gravity of 9.8 g/cm\3\ and is composed of 88 percent tungsten, 4
percent nickel, 2 percent iron, 1 percent copper, and 5 percent
polymers by mass. After consultation with us, Kent has subsequently
changed the composition of their shot and removed nickel and copper.
The new shot material being considered has a density of 10.7 g/cm\3\
and is composed of approximately 95.9 percent tungsten and 4.1 percent
polymers.
ITRI's candidate shot is made from commercially pure tin; no
alloying or other alterations are intentionally made to the chemical
composition of the shot. This shot material has a density of
approximately 7.29 g/cm\3\, and is 99.9 percent tin, with a low level
of iron pickup due to the steel production equipment.
Each of Federal's applications for tungsten-iron and tungsten-
polymer include a description of the shot, a toxicological report (Barr
1996), results of a 30-day dosing study of the toxicity of the shot in
game-farm mallards (Bursian et al. 1996a, Bursian et al. 1996b), and
results of a 150-day reproductive/chronic toxicity study (Bursian et
al. 1999). Kent's application for tungsten-matrix includes a
description of the shot, a toxicological report (Thomas 1997a), and
results of a 30-day toxicity study (Wildlife International, Ltd.
1998a). The tin shot application from ITRI contains a description of
the shot, a toxicological report (Thomas 1997b), and results of a 30-
day toxicity study (Wildlife International, Ltd. 1998b). Toxicological
reports for each shot type incorporates toxicity information (a
synopsis of acute and chronic toxicity data for mammals and birds,
potential for environmental concern, and toxicity to aquatic and
terrestrial invertebrates, amphibians and reptiles) and information on
environmental fate and transport (shot alteration, environmental half-
life, and environmental concentration).
Toxicity Information
There is considerable difference in the toxicity of soluble and
insoluble compounds of tungsten and iron. Elemental tungsten and iron
are virtually insoluble and are therefore expected to be relatively
nontoxic. Even though most toxicity tests reviewed were based on
soluble tungsten compounds rather than elemental tungsten, there
appears to be no basis for concern of toxicity to wildlife for either
candidate shot via ingestion by fish or mammals (Bursian et al. 1996b,
Gigiena 1983, Karantassis 1924, Patty 1982, Industrial Medicine 1946).
Detailed reviews of the toxicological impacts of different tin
compounds have been conducted by Eisler (1989) and Cooney (1988). Both
reviews indicate that elemental tin is non-toxic to animals. Tin shot
designed for waterfowl hunting is utilized in several European
countries and no reports exist that suggest that tin shot is causing
toxicity problems for wildlife in those countries.
The potential toxicity of nylon compounds due to degradation is
primarily associated with the stabilizers, antioxidants, plasticizers,
and unreacted prepolymers. Residual caprolactum has been found in some
commercial Nylon 6 products, but little concern regarding this compound
has been developed (Patty, 1982). The toxicity of Nylon 6 and 11 are
negligible due to their insolubilities.
Environmental Fate and Transport
Tungsten is insoluble in water and therefore not mobile in
hypergenic
[[Page 45401]]
environments. Tungsten is very stable with acids and does not easily
complex. Preferential uptake by plants in acid soil suggests uptake of
tungsten in the anionic form associated with tungsten minerals rather
than elemental tungsten (Kabata and Pendias 1984). Tin pellets will
undergo slow surface oxidation to form hydrated tin oxide, which is
extremely insoluble in water (Lide 1990). Therefore dissolution will be
slow, and highly localized aqueous concentrations will not arise. This
means that elemental tin will over time remain largely in the same
inorganic form as when it is discharged. Tin pellets discharged into
wetlands where sulphur ions are released during organic decomposition
would become coated with tin sulphide, which is highly insoluble in
water and resistant to aquatic hydrolysis (Hoiland 1995).
Environmental Concentration
The effective environmental concentration (EEC) for a terrestrial
ecosystem was calculated based on 69,000 shot per hectare (Pain 1990),
assuming complete erosion of material in 5 cm of soil. For tungsten-
iron shot, the EEC for tungsten in soil was calculated at 32.9 mg/kg.
For tungsten-polymer shot, the EECs for tungsten and Nylon (6 and 11)
in soil are 58.3 mg/kg and 2.7 mg/kg, respectively. The EECs for
tungsten and the 2 polymers found in tungsten-matrix are 25.7 mg/kg,
4.2 mg/kg, and 0.14 mg/kg, respectively. The EEC for tin in soil is
19.3 g/m3.
The environmental concentration (EEC) for an aquatic ecosystem was
calculated assuming complete erosion of the shot in one cubic foot of
water. For tungsten-iron shot, the EEC in water for tungsten was 10.5
mg/L. For tungsten-polymer shot, the EECs in water for tungsten and
Nylon (6 and 11) are 18.7 mg/L and 0.9 mg/L, respectively. The EECs in
water for tungsten and the 2 polymers found in tungsten-matrix are 4.2
mg/L, 0.2 mg/L, and 0.02 mg/L, respectively. The EEC in water for tin
is 19.3 mg/L.
Effects on Birds
An extensive literature review in each application provided
information on the toxicity of elemental tungsten and tin to waterfowl
and other birds. Ringelman et al. (1993) orally dosed 20 8-week-old
game-farm mallards with 12-17 (1.03 g average weight) tungsten-bismuth-
tin (TBT) pellets and monitored them for 32 days for evidence of
intoxication. No birds died during the trial, gross lesions were not
observed during the postmortem examinations, histopathological
examinations did not reveal any evidence of toxicity or tissue damage,
and tungsten was not detectable in kidney or liver samples. The authors
concluded that TBT shot presented virtually no potential for acute
intoxication in mallards.
Kraabel et al. (1996) assessed the effects of embedded TBT shot on
mallards and concluded that TBT was not acutely toxic when implanted in
muscle tissue. Inflammatory reactions to TBT shot were localized and
had no detectable systemic effects on mallard health.
Nell (1981) fed laying hens (Gallus domesticus) 0.4 or 1.0 g/kg
tungsten in a commercial mash for five months to assess reproductive
performance. Weekly egg production was normal and hatchability of
fertile eggs was not affected. Exposure of chickens to large doses of
tungsten either through injection or by feeding resulted in an
increased tissue concentration of tungsten and a decreased
concentration of molybdenum (Nell 1981). The loss of tungsten from the
liver occurred in an exponential manner with a half-life of 27 hours.
The alterations in molybdenum metabolism seemed to be associated with
tungsten intake rather than molybdenum deficiency. Death due to
tungsten occurred when tissue concentrations increased to 25 mg/g
liver. At that concentration, xanthine dehydrogenase activity was zero.
Ringelman et al. (1992) conducted a 32-day acute toxicity study
which involved dosing game-farm mallards with a shot alloy of tungsten-
bismuth-tin (TBT), which was 39, 44.5 and 16.5 percent by weight,
respectively. No dosed birds died during the trial, and behavior was
normal. Examination of tissues post-euthanization revealed no toxicity
or damage related to shot exposure. This study concluded that ``. . .
TBT shot presents virtually no potential for acute intoxication in
mallards under the conditions of this study.''
Several studies have been conducted in which pellets made of tin or
tin alloys have been placed inside the digestive tract or tissues of
ducks to determine if toxic effects occur. Grandy et al. (1968) and the
Huntingdon Research Centre (1987) conducted 30- and 28-day,
respectively, acute toxicity tests on mallard ducks and reported that
all treatment ducks survived with insignificant weight loss or
development of pathological lesions. The potential for bismuth-tin (BT)
shot to produce toxicological effects in ducks during reproduction has
been investigated under both acute and chronic testing conditions. Tin
as a 2% component of the tested shot, did not pose a toxic risk to
ducks when fed a nutritionally-imbalanced, corn-based diet. Neither has
BT shot been shown to pose an adverse risk to the health of ducks, the
reproduction by male and female birds, nor the survival of ducklings
over the long term (Sanderson et al. 1997a,b).
Nylon 6 is the commercially important homopolymer of caprolactum.
Most completely polymerized nylon materials are physiologically inert,
regardless of the toxicity of the monomer from which they are made
(Peterson 1977). Few data exist on the toxicity of Nylon 6 in animals.
Most toxicity studies are related to thermal degradation products and
so are not relevant to the exposure of wildlife to shot containing
nylon. Montgomery (1982) reported that feeding Nylon 6 to rats at a
level of 25 percent of the diet for 2 weeks caused a slower rate of
weight gain, presumably due to a decrease in food consumption and feed
efficiency. However, the rats suffered no anatomic injuries due to the
consumption of nylon.
The two plastic polymers used in tungsten-matrix shot act as a
physical matrix in which the tungsten is distributed as ionically-bound
fine particles. Most completely polymerized nylon materials are
physiologically inert, regardless of the toxicity of the monomer from
which they are made (Peterson 1977). A literature review did not reveal
studies in which either of the two polymers were evaluated for toxicity
in birds.
Acute Toxicity Studies
Federal contracted with Michigan State University--Department of
Animal Science, to conduct an acute toxicity study of tungsten-iron and
tungsten-polymer. Both Kent and ITRI contracted with Wildlife
International Ltd. to conduct an acute toxicity study of tungsten-
matrix and tin shots, respectively. The acute toxicity test is a short-
term (30-day) study where ducks are dosed with shot and fed
commercially available duck food. Survival, body weight, blood
hematocrit, and organ analysis are recorded.
Tungsten-iron and tungsten-polymer
The 30-day dosing study revealed no adverse effects when mallards
were dosed with either 8 BB size tungsten-iron shot or 8 BB size
tungsten-polymer shot and monitored over a 30-day period (Bursian et
al. 1996a, Bursian et al. 1996b). Eight male and 8 female adult
mallards were dosed with either 8 No.4 steel shot, 8 No.4 lead shot, 8
BB size tungsten-iron shot, or 8 BB size tungsten-polyer shot and
observed over
[[Page 45402]]
a 30-day period. An additional 8 males and 8 females received no shot.
Fifty percent of the lead-dosed birds (5 males and 3 females) died
during the 30-day test while there were no mortalities in the other
groups. Lead-dosed birds were the only ones to display green excreta,
lethargy, and ataxia. Body weights were not significantly altered by
any of the treatments, although lead-dosed birds which died during the
trial lost an average of 30 percent of their body weight. Hematocrit,
hemoglobin concentrations, and ALAD activity were significantly
depressed at day 15 in the lead-dosed females, while lead-dosed males
had significantly depressed hematocrit and hemoglobin concentration
compared with the other four groups. There were no significant
differences in these whole-blood parameters at day 30. Three tungsten-
polymer-dosed males developed mild biliary stasis. The authors
attributed this to the intubating of mallards with 8 BBs of tungsen-
polymer shot inducing a pathological condition--however slight--that
was not found in the control birds. No other histopathological lesions
were found. Tungsten was detected in the femur of two tungsten-polymer-
dosed females and the kidneys of two tungsten-polymer-dosed birds; in
both tissues, concentrations were only slightly above detection limits.
In general, no adverse effects were seen in mallards given 8 BB-size
tungsten-polymer shot and monitored over a 30-day period.
Tungsten-matrix
Kent's 30-day dosing study (Wildlife International Ltd. 1998a)
included 4 treatment and 1 control group of game-farm mallards.
Treatment groups were exposed to 1 of 3 different types of shot: 8 #4
steel, 8 #4 lead, or 8 #4 tungsten-matrix; whereas the control group
received no shot. The 2 tungsten-matrix treatment groups (1 group
deficient diet, 1 group balanced diet) each consisted of 16 birds (8
males and 8 females); whereas remaining treatment and control groups
consisted of 6 birds each (3 males and 3 females). All tungsten-matrix-
dosed birds survived the test and showed no overt signs of toxicity or
treatment-related effects on body weight. There were no differences in
hematocrit or hemoglobin concentration between the tungsten-matrix
treatment group and either the steel shot or control groups. No
histopathological lesions were found during gross necropsy. In general,
no adverse effects were seen in mallards given 8 #4 size tungsten-
matrix shot and monitored over a 30-day period. Tungsten was found to
be below the limit of detection in all samples of femur, gonad, liver,
and kidney from treatment groups.
Tin
ITRI's 30-day dosing study (Wildlife International Ltd. 1998b)
included 4 treatment and 1 control group of game-farm mallards.
Treatment groups were exposed to 1 of 3 different types of shot: 8 #4
steel, 8 #4 lead, or 8 #4 tin shot; whereas the control group received
no shot. The 2 tin treatment groups (1 group deficient diet, 1 group
balanced diet) each consisted of 16 birds (8 males and 8 females);
whereas remaining treatment and control groups consisted of 6 birds
each (3 males and 3 females). All tin-dosed birds survived the test and
showed no overt signs of toxicity or treatment-related effects on body
weight. There were no differences in hematocrit or hemoglobin
concentration between the tin treatment group and either the steel shot
or control groups. No histopathological lesions were found during gross
necropsy. In general, no adverse effects were seen in mallards given 8
#4 size tin shot and monitored over a 30-day period. No levels of tin
above the limit of detection were observed in any tissues collected
from either tin treatment group.
Reproductive/Chronic Toxicity Study
Federal contracted with Michigan State University--Department of
Animal Science, to conduct an a reproductive/chronic toxicity studies
for both tungsten-iron and tungsten-polymer shot types. The
reproductive/chronic toxicity study is a long-term (150-day) study
where ducks are dosed with shot and fed commercially available duck
food. Survival, body weight, blood hematocrit, organ analysis, and
reproductive performance are recorded.
Tungsten-Iron and Tungsten-Polymer
The reproductive/chronic toxicity study revealed no adverse effects
when mallards were dosed with either 8 No. 4 size tungsten-iron shot,
or 8 No. 4 size tungsten-polymer shot, and monitored over a 150-day
period (Bursian et al. 1999). Sixteen male and 16 female adult mallards
were orally dosed with either 8 No.4 steel shot, 8 No.4 tungsten-iron
shot, or 8 No. 4 tungsten-polymer shot. An additional 6 male and 6
female mallards were dosed with 8 No. 4 lead shot. All lead-dosed birds
died by day 25 of the study, whereas no mortalities occurred in the
other test groups. Lead-dosed birds had significantly decreased
hematocrit, hemoglobin concentration and whole-blood delta
aminolevulinic dehydratase activity on day 7 of the study. Mallards
dosed with tungsten-iron or tungsten-polymer shot had occasional
significant differences in hematocrit and plasma chemistry values when
compared to steel-dosed mallards over the 150-day period, but these
changes were within the normal range reported for mallards and were not
considered to be deleterious. Relative kidney, heart, brain and gizzard
weights of lead-dosed birds were significantly greater in comparison to
relative weights of those organs in the other 3 treatment groups.
Marked liver hemosiderosis was present in all steel and tungsten-dosed
males, in 5 of 8 steel-and 3 of 8 tungsten-iron-dosed females, and in 1
tungsten-polymer-dosed male examined. Small amounts of tungsten were
detected in gonad and kidney samples from males and females, in femur
samples of males, and in liver samples from females dosed with
tungsten-polymer shot. Higher concentrations of tungsten were detected
in femur, gonad, kidney, and liver samples from tungsten-iron-dosed
ducks. The rate of shot erosion was 99% for tungsten-polymer, 72% for
tungsten-iron, 55% for steel, and 37% for lead. There were no
significant differences in percent egg production, and percent
fertility and hatchability of eggs from tungsten-iron- and tungsten-
polymer-dosed ducks when compared to steel-dosed ducks. There were no
biological differences in percent survivability and body weight of
ducklings from tungsten-iron-or tungsten-polymer-dosed ducks when
compared to ducklings from steel-dosed ducks. The hematocrit of
ducklings from tungsten-iron-dosed ducks was slightly but significantly
lower when compared to ducklings from steel-dosed ducks. Histological
examination of duckling kidneys and liver indicated no abnormalities.
Tungsten was detected in 25%, 9%, and 13% of the femur, kidneys, and
liver samples, respectively, from ducklings of the tungsten-iron and
tungsten-polymer groups. Overall, results of this study indicated that
tungsten-iron and tungsten-polymer shot repeatedly administered to
adult mallards did not adversely affect them or the offspring they
produced during the 150-day trial.
Nontoxic Shot Approval
The first condition of nontoxic shot approval is toxicity testing.
Based on the results of the toxicological report and the toxicity tests
(Tiers 1, 2, and 3) discussed above, we conclude that tungsten-iron and
tungsten-polymer shot does not pose a significant danger to migratory
birds or other wildlife and their habitats. Based on the results of
toxicological reports and acute toxicity tests (Tier 1 and 2), we
conclude that tungsten-matrix and tin shots do not
[[Page 45403]]
appear to pose a significant danger to migratory birds or other
wildlife and their habitats. However, final approval of either shot
type will not be considered until all required reproductive/chronic
toxicity tests have been successfully completed and our Director has
reviewed and approved the results.
The second condition of approval is testing for residual lead
levels. Any shot with lead levels equal to or exceeding 1 percent will
be considered toxic and, therefore, illegal. We have determined that
the maximum environmentally acceptable level of lead in any nontoxic
shot is trace amounts of <1 percent,="" and="" incorporated="" this="" requirement="" in="" the="" nontoxic="" shot="" approval="" process="" that="" was="" published="" on="" december="" 1,="" 1997="" (62="" fr="" 63608).="" federal="" has="" documented="" that="" tungsten-iron="" and="" tungsten-polymer="" shots="" meet="" this="" requirement.="" kent="" and="" itri="" have="" documented="" that="" tungsten-matrix="" and="" tin="" shot,="" respectively,="" meet="" this="" requirement.="" the="" third="" condition="" of="" approval="" involves="" enforcement.="" in="" the="" august="" 18,="" 1995,="" federal="" register="" (60="" fr="" 43314),="" we="" indicated="" that="" approval="" of="" any="" nontoxic="" shot="" would="" be="" contingent="" upon="" the="" development="" and="" availability="" of="" a="" noninvasive="" field="" testing="" device.="" this="" requirement="" was="" incorporated="" in="" the="" nontoxic="" shot="" approval="" process="" that="" was="" published="" on="" december="" 1,="" 1997="" (62="" fr="" 63608).="" tungsten-iron="" shotshells="" can="" be="" drawn="" to="" a="" magnet="" as="" a="" simple="" field="" detection="" method.="" electronic="" field="" testing="" devices="" can="" distinguish="" shells="" containing="" tungsten-="" polymer="" and="" tungsten-matrix="" from="" shells="" containing="" lead.="" at="" the="" present="" time,="" we="" are="" not="" aware="" of="" any="" noninvasive="" field="" testing="" devices="" for="" distinguishing="" shells="" containing="" tin="" shot="" from="" those="" containing="" lead.="" we="" will="" not="" consider="" final="" approval="" of="" tin="" shot="" until="" such="" a="" device,="" or="" other="" noninvasive="" field="" testing="" method,="" has="" been="" developed="" for="" identifying="" tin="" shot.="" in="" summary,="" this="" rule="" amends="" 50="" cfr="" 20.21(j)="" by="" approving="" tungsten-="" iron="" and="" tungsten-polymer="" shots="" as="" nontoxic="" for="" migratory="" bird="" hunting.="" it="" is="" based="" on="" the="" toxicological="" reports,="" acute="" toxicity="" studies,="" and="" reproductive/chronic="" toxicity="" studies="" submitted="" by="" federal.="" results="" of="" these="" studies="" indicate="" the="" absence="" of="" any="" deleterious="" effects="" of="" tungsten-iron="" or="" tungsten-polymer="" shot="" when="" ingested="" by="" captive-reared="" mallards="" or="" to="" the="" ecosystem.="" this="" rule="" also="" grants="" temporary="" approval="" to="" tungsten-matrix="" and="" tin="" shots="" for="" the="" 1999-2000="" hunting="" season="" only.="" temporary="" approval="" is="" based="" on="" the="" toxicological="" reports="" and="" acute="" toxicity="" studies="" submitted="" by="" kent="" and="" itri.="" during="" the="" 1998-99="" hunting="" season,="" we="" granted="" temporary="" approval="" of="" several="" shot="" types="" that="" contained="" tungsten="" (october="" 7,="" 1998,="" 63="" fr="" 54016-54026;="" december="" 8,="" 1998,="" 63="" fr="" 67619).="" we="" gave="" these="" approvals="" with="" the="" restriction="" that="" the="" shot="" types="" could="" not="" be="" used="" in="" the="" yukon-kuskokwim="" (y-k)="" delta,="" alaska.="" this="" restriction="" was="" implemented="" out="" of="" concern="" for="" potential="" effects="" of="" tungsten="" on="" the="" spectacled="" eider="" (somateria="" fischeri);="" a="" species="" subject="" to="" adverse="" weather,="" predation,="" and="" lead="" poisoning="" on="" the="" y-k="" delta.="" based="" on="" the="" results="" of="" reproductive/chronic="" toxicity="" studies="" of="" tungsten-iron="" and="" tungsten-="" polymer,="" we="" see="" no="" need="" for="" the="" y-k="" delta="" restriction="" on="" any="" tungsten-="" based="" shot="" types.="" public="" comments="" and="" responses="" we="" invited="" public="" comments="" from="" interested="" parties="" in="" the="" june="" 17,="" 1999,="" proposed="" rule="" published="" in="" the="" federal="" register="" (64="" fr="" 32752).="" during="" the="" 30-day="" comment="" period,="" we="" received="" 4="" comments.="" the="" wildlife="" legislative="" fund="" of="" america="" strongly="" supported="" the="" temporary="" approval="" of="" tungsten-matrix="" and="" tin="" shots="" for="" hunting="" migratory="" birds="" in="" order="" to="" provide="" additional="" nontoxic="" shot="" alternatives="" to="" hunters.="" senator="" john="" d.="" rockefeller="" iv="" also="" supported="" the="" temporary="" approval="" of="" tungsten-matrix="" shot.="" kent="" acknowledged="" the="" conditions="" for="" nontoxic="" approval="" and="" indicated="" that="" chronic="" toxicity/reproductive="" test="" results="" for="" tungsten-="" matrix="" shot="" are="" proceeding="" satisfactorily.="" itri="" indicated="" that="" chronic="" toxicity/reproductive="" tests="" are="" being="" completed="" for="" tin="" shot="" and="" a="" noninvasive="" field="" testing="" device="" will="" be="" available.="" service="" response:="" we="" are="" encouraged="" that="" chronic="" toxicity/="" reproductive="" testing="" is="" being="" completed="" for="" tungsten-matrix="" and="" tin="" shots,="" and="" look="" forward="" to="" reviewing="" results="" of="" such="" tests="" when="" they="" become="" available.="" it="" is="" our="" hope="" that="" providing="" additional="" nontoxic="" shot="" alternatives="" will="" improve="" hunter="" compliance="" and="" reduce="" the="" amount="" of="" lead="" shot="" in="" the="" environment.="" effective="" date="" under="" the="" apa="" (5="" u.s.c.="" 553="" (d))="" we="" waive="" the="" 30-day="" period="" before="" this="" rule="" becomes="" effective="" and="" find="" that="" ``good="" cause''="" exists,="" within="" the="" terms="" of="" 5="" u.s.c.="" 553(d)(3)="" of="" the="" apa,="" and="" this="" rule="" will,="" therefore,="" take="" effect="" immediately="" upon="" publication.="" this="" rule="" relieves="" a="" restriction="" and,="" in="" addition,="" it="" is="" not="" in="" the="" public="" interest="" to="" delay="" the="" effective="" date="" of="" this="" rule.="" it="" is="" in="" the="" best="" interest="" of="" migratory="" birds="" and="" their="" habitats="" to="" grant="" approval="" to="" tungsten-iron="" and="" tungsten-polymer="" shot="" as="" nontoxic="" for="" hunting="" migratory="" birds,="" and="" to="" grant="" temporary="" approval="" to="" tungsten-matrix="" and="" tin="" shot="" for="" the="" 1998-99="" migratory="" bird="" hunting="" season="" only.="" it="" is="" in="" the="" best="" interest="" of="" the="" hunting="" public="" to="" provide="" them="" an="" additional="" legal="" option="" for="" hunting="" waterfowl="" and="" coots="" for="" the="" 1999-2000="" season,="" which="" begins="" on="" september="" 1,="" 1999.="" it="" is="" in="" the="" best="" interest="" of="" small="" retailers="" who="" have="" stocked="" the="" above="" shot="" types="" for="" the="" current="" season.="" we="" believe="" that="" availability="" of="" additional="" nontoxic="" shot="" options="" likely="" will="" improve="" hunter="" compliance,="" thereby="" reducing="" the="" amount="" of="" lead="" shot="" in="" the="" environment.="" references="" barr="" engineering="" company.="" 1996.="" toxicology="" report="" on="" new="" shot.="" bursian,="" s.="" j.,="" m.="" e.="" kelly,="" r.="" j.="" aulerich,="" d.="" c.="" powell,="" and="" s.="" fitzgerald.="" 1996a.="" thirty-day="" dosing="" test="" to="" assess="" the="" toxicity="" of="" tungsten-iron="" shot="" in="" game-farm="" mallards.="" report="" to="" federal="" cartridge="" co.="" 77="" pp.="" bursian,="" s.="" j.,="" m.="" e.="" kelly,="" r.="" j.="" aulerich,="" d.="" c.="" powell,="" and="" s.="" fitzgerald.="" 1996b.="" thirty-day="" dosing="" test="" to="" assess="" the="" toxicity="" of="" tungsten-polymer="" shot="" in="" game-farm="" mallards.="" report="" to="" federal="" cartridge="" co.="" 71="" pp.="" bursian,="" s.="" j.,="" r.="" m.="" mitchell,="" r.="" j.="" tempelman,="" r.="" j.="" aulerich,="" and="" s.="" d.="" fitzgerald.="" 1999.="" chronic="" dosing="" study="" to="" assess="" the="" health="" and="" reproductive="" effects="" of="" tungsten-iron="" and="" tungsten-polymer="" shot="" on="" game-farm="" mallards.="" report="" to="" federal="" cartridge="" co.="" 115="" pp.="" cooney,="" j.j.="" 1988.="" microbial="" transformations="" of="" tin="" and="" tin="" compounds.="" j.="" industr.="" microbiol.="" 3:195-204.="" eisler,="" r.="" 1989.="" tin="" hazards="" to="" fish,="" wildlife,="" and="" invertebrates:="" a="" synoptic="" review.="" biological="" rep.="" 85="" (1.15).="" contaminant="" hazard="" reviews="" report="" no.="" 15.="" fish="" and="" wildlife="" service,="" u.s.="" dept.="" interior.="" washington,="" d.c.="" 85="" pp.="" gigiema="" i.="" sanitariya.="" 1977.="" mezhdunarodnaya="" kniga.="" moscow,="" ussr.="" 42(8):30.="" gigiema="" i.="" sanitariya.="" 1983.="" mezhdunarodnaya="" kniga.="" moscow,="" ussr.="" 48(7):71.="" grandy,="" j.="" w.,="" l.="" n.="" locke,="" and="" g.="" e.="" bagley.="" 1968.="" relative="" toxicity="" of="" lead="" and="" five="" proposed="" substitute="" shot="" types="" to="" pen-="" reared="" mallards.="" j.="" wildl.="" manage.="" 32(3):483-488.="" hoiland,="" k.="" 1995.="" reaction="" of="" some="" decomposer="" basidiomycetes="" to="" toxic="" elements.="" nordic="" j.="" bot.="" 15:305-318.="" huntingdon="" research="" centre="" ltd.="" 1987.="" the="" effects="" of="" dosing="" mallard="" ducks="" with="" safe="" shot.="" huntingdon,="" cambridge,="" u.k.="" report="" dated="" dec.="" 19,="" 1987.="" 15pp.="" industrial="" medicine.="" 1946.="" 15:482.="" interagency="" ecosystem="" management="" task="" force.="" 1995.="" the="" ecosystem="" approach:="" healthy="" ecosystems="" and="" sustainable="" economics.="" volume="" ii--="" implementation="" issues.="" [[page="" 45404]]="" kabata-pendias,="" a.="" and="" h.="" pendias.="" 1984.="" trace="" elements="" in="" soil="" and="" plants.="" crc="" press,="" inc.="" boca="" raton,="" fl.="" karantassis,="" t.="" 1924.="" on="" the="" toxicity="" of="" compounds="" of="" tungsten="" and="" molybdenum.="" ann.="" med.="" 28:1541-1543.="" kraabel,="" f.="" w.,="" m.="" w.="" miller,="" d.="" m.="" getzy,="" and="" j.="" k.="" ringleman.="" 1996.="" effects="" of="" embedded="" tungsten-bismuth-tin="" shot="" and="" steel="" shot="" on="" mallards.="" j.="" wildl.="" dis.="" 38(1):1-8.="" lide,="" d.r.="" 1990.="" crc--handbook="" of="" chemistry="" and="" physics.="" 71st="" edition,="" 1990-1991.="" crc="" press,="" boca="" raton,="" florida.="" montgomery,="" r.r.="" 1982.="" polymers.="" in="" patty's="" industrial="" hygiene="" and="" toxicology,="" vol.="" iiia="" (g.d.="" clayton="" and="" f.e.="" clayton,="" eds.)="" pp.="" 4209-4526.="" john="" wiley="" and="" sons,="" ny.="" nell,="" j.a.,="" e.f.="" annison,="" and="" d.="" balnave.="" 1981.="" the="" influence="" of="" tungsten="" on="" the="" molybdenum="" status="" of="" poultry.="" br.="" poult.="" sci.="" 21:193-202.="" pain,="" d.j.="" 1990.="" lead="" shot="" ingestion="" by="" waterbirds="" in="" the="" carmarque,="" france:="" an="" investigation="" of="" levels="" and="" interspecific="" difference.="" environ.="" pollut.="" 66:273-285.="" patty's="" industrial="" hygiene="" and="" toxicology.="" 1982.="" wiley="" interscience.="" wiley="" &="" sons,="" inc.="" ny,="" ny.="" third="" ed.="" peterson,="" j.e.="" 1977.="" industrial="" health.="" prentice-hall,="" englewood="" cliffs,="" nj.="" ringelman,="" j.k.,="" m.w.="" miller,="" and="" w.f.="" andelt.="" 1992.="" effects="" of="" ingested="" tungsten-bismuth-tin="" shot="" on="" mallards.="" co="" div.="" wildl.,="" fort="" collins,="" 24="" pp.="" ringelman,="" j.k.,="" m.w.="" miller,="" and="" w.f.="" andelt.="" 1993.="" effects="" of="" ingested="" tungsten-bismuth-tin="" shot="" on="" captive="" mallards.="" j.="" wildl.="" manage.="" 57:725-732.="" sanderson,="" g.c.,="" w.l.="" anderson,="" g.l.="" foley,="" l.m.="" skowron,="" j.d.="" brawn,="" and="" j.w.="" seets.="" 1997a.="" acute="" toxicity="" of="" ingested="" bismuth="" alloy="" shot="" in="" game="" farm="" mallards.="" illinois="" nat.="" history="" survey="" bull.="" 35:185-216.="" sanderson,="" g.c.,="" w.l.="" anderson,="" g.l.="" foley,="" k.l.="" duncan,="" l.m.="" skowron,="" j.d.="" brawn,="" and="" j.w.="" seets.="" 1997b.="" toxicity="" of="" ingested="" bismuth="" alloy="" shot="" in="" game="" farm="" mallards:="" chronic="" health="" effects="" and="" effects="" on="" reproduction.="" illinois="" nat.="" history="" survey="" bull.="" 35:217-="" 252.="" thomas,="" v.g.="" 1997a.="" application="" for="" approval="" of="" tungsten-matrix="" shot="" as="" non-toxic="" for="" the="" hunting="" of="" migratory="" birds.="" 39="" pp.="" thomas,="" v.g.="" 1997b.="" application="" for="" approval="" of="" tin="" shot="" as="" non-="" toxic="" for="" the="" hunting="" of="" migratory="" birds.="" 26="" pp.="" wildlife="" international,="" ltd.="" 1998a.="" tungsten-matrix="" shot:="" an="" oral="" toxicity="" study="" with="" the="" mallard.="" project="" no.="" 475-101.="" 162="" pp.="" wildlife="" international,="" ltd.="" 1998b.="" tin="" shot:="" an="" oral="" toxicity="" study="" with="" the="" mallard.="" project="" no.="" 476-101.="" 158="" pp.="" nepa="" consideration="" in="" compliance="" with="" the="" requirements="" of="" section="" 102(2)(c)="" of="" the="" national="" environmental="" policy="" act="" of="" 1969="" (42="" u.s.c.="" 4332(c)),="" and="" the="" council="" on="" environmental="" quality's="" regulation="" for="" implementing="" nepa="" (40="" cfr="" 1500-1508),="" we="" prepared="" environmental="" assessments="" (ea)="" in="" july,="" 1999.="" the="" eas="" are="" available="" to="" the="" public="" at="" the="" location="" indicated="" under="" the="" addresses="" caption.="" based="" on="" review="" and="" evaluation="" of="" the="" information="" in="" the="" eas,="" we="" have="" determined="" that="" amending="" 50="" cfr="" 20.21(j)="" to="" provide="" final="" approval="" of="" tungsten-iron="" and="" tungsten-="" polymer="" shots,="" and="" temporary="" approval="" of="" tungsten-matrix="" and="" tin="" shots="" for="" the="" 1999-2000="" season,="" as="" nontoxic="" for="" migratory="" bird="" hunting="" would="" not="" be="" a="" major="" federal="" action="" that="" would="" significantly="" affect="" the="" quality="" of="" the="" human="" environment.="" endangered="" species="" act="" considerations="" section="" 7="" of="" the="" endangered="" species="" act="" (esa)="" of="" 1972,="" as="" amended="" (16="" u.s.c.="" 1531="" et="" seq.),="" provides="" that="" federal="" agencies="" shall="" ``insure="" that="" any="" action="" authorized,="" funded="" or="" carried="" out="" *="" *="" *="" is="" not="" likely="" to="" jeopardize="" the="" continued="" existence="" of="" any="" endangered="" species="" or="" threatened="" species="" or="" result="" in="" the="" destruction="" or="" adverse="" modification="" of="" (critical)="" habitat="" *="" *="" *''="" we="" have="" completed="" a="" section="" 7="" consultation="" under="" the="" esa="" for="" this="" rule,="" which="" stated="" the="" use="" of="" tungsten-iron,="" tungsten-polymer,="" tungsten-matrix,="" and="" tin="" shots="" is="" not="" likely="" to="" adversely="" affect="" listed="" species.="" the="" result="" of="" our="" consultation="" under="" section="" 7="" of="" the="" esa="" is="" available="" to="" the="" public="" at="" the="" location="" indicated="" under="" the="" addresses="" caption.="" regulatory="" flexibility="" act;="" small="" business="" regulatory="" enforcement="" and="" fairness="" act="" the="" regulatory="" flexibility="" act="" of="" 1980="" (5="" u.s.c.="" 601="" et="" seq.)="" requires="" the="" preparation="" of="" flexibility="" analyses="" for="" rules="" that="" will="" have="" a="" significant="" effect="" on="" a="" substantial="" number="" of="" small="" entities,="" which="" includes="" small="" businesses,="" organizations="" or="" governmental="" jurisdictions.="" this="" rule="" approves="" additional="" types="" of="" nontoxic="" shot="" that="" may="" be="" sold="" and="" used="" to="" hunt="" migratory="" birds;="" this="" rule="" provides="" 4="" types="" of="" shot="" in="" addition="" to="" the="" existing="" 2="" that="" are="" approved.="" we="" have="" determined,="" however,="" that="" this="" rule="" will="" have="" no="" effect="" on="" small="" entities="" since="" the="" approved="" shots="" merely="" will="" supplement="" nontoxic="" shot="" already="" in="" commerce="" and="" available="" throughout="" the="" retail="" and="" wholesale="" distribution="" systems.="" we="" anticipate="" no="" dislocation="" or="" other="" local="" effects,="" with="" regard="" to="" hunters="" and="" others.="" similarly,="" this="" is="" not="" a="" major="" rule="" under="" 5="" u.s.c.="" 804(2).="" executive="" order="" 12866="" this="" rule="" is="" not="" subject="" to="" office="" of="" management="" and="" budget="" (omb)="" review="" under="" executive="" order="" 12866.="" e.o.="" 12866="" requires="" each="" agency="" to="" write="" regulations="" that="" are="" easy="" to="" understand.="" we="" invite="" comments="" on="" how="" to="" make="" this="" rule="" easier="" to="" understand,="" including="" answers="" to="" questions="" such="" as="" the="" following:="" (1)="" are="" the="" requirements="" in="" the="" rule="" clearly="" stated?="" (2)="" does="" the="" rule="" contain="" technical="" language="" or="" jargon="" that="" interferes="" with="" its="" clarity?="" (3)="" does="" the="" format="" of="" the="" rule="" (grouping="" and="" order="" of="" sections,="" use="" of="" headings,="" paragraphing,="" etc.)="" aid="" or="" reduce="" its="" clarity?="" (4)="" would="" the="" rule="" be="" easier="" to="" understand="" if="" it="" were="" divided="" into="" more="" (but="" shorter)="" sections?="" (5)="" is="" the="" description="" of="" the="" rule="" in="" the="" ``supplementary="" information''="" section="" of="" the="" preamble="" helpful="" in="" understanding="" the="" rule?="" what="" else="" could="" we="" do="" to="" make="" the="" rule="" easier="" to="" understand?="" paperwork="" reduction="" act="" an="" agency="" may="" not="" conduct="" or="" sponsor,="" and="" a="" person="" is="" not="" required="" to="" respond="" to,="" a="" collection="" of="" information="" unless="" it="" displays="" a="" currently="" valid="" omb="" control="" number.="" we="" have="" examined="" this="" regulation="" under="" the="" paperwork="" reduction="" act="" of="" 1995="" (44="" u.s.c.="" 3501)="" and="" found="" it="" to="" contain="" no="" information="" collection="" requirements.="" however,="" we="" do="" have="" omb="" approval="" (1018-0067;="" expires="" 06/30/2000)="" for="" information="" collection="" relating="" to="" what="" manufacturers="" of="" shot="" are="" required="" to="" provide="" to="" us="" for="" the="" nontoxic="" shot="" approval="" process.="" for="" further="" information="" see="" 50="" cfr="" 20.134.="" unfunded="" mandates="" reform="" we="" have="" determined="" and="" certify="" pursuant="" to="" the="" unfunded="" mandates="" act,="" 2="" u.s.c.="" 1502,="" et="" seq.,="" that="" this="" rulemaking="" will="" not="" impose="" a="" cost="" of="" $100="" million="" or="" more="" in="" any="" given="" year="" on="" local="" or="" state="" government="" or="" private="" entities.="" civil="" justice="" reform--executive="" order="" 12988="" we,="" in="" promulgating="" this="" rule,="" have="" determined="" that="" these="" regulations="" meet="" the="" applicable="" standards="" provided="" in="" sections="" 3(a)="" and="" 3(b)(2)="" of="" executive="" order="" 12988.="" takings="" implication="" assessment="" in="" accordance="" with="" executive="" order="" 12630,="" these="" rules,="" authorized="" by="" the="" migratory="" bird="" treaty="" act,="" do="" not="" have="" significant="" takings="" implications="" and="" do="" not="" affect="" any="" constitutionally="" protected="" property="" rights.="" these="" rules="" will="" not="" result="" in="" the="" physical="" occupancy="" of="" property,="" the="" physical="" invasion="" of="" property,="" or="" the="" regulatory="" taking="" of="" any="" property.="" in="" fact,="" these="" rules="" allow="" hunters="" to="" exercise="" privileges="" that="" would="" be="" otherwise="" unavailable;="" and,="" therefore,="" reduce="" restrictions="" on="" the="" use="" of="" private="" and="" public="" property.="" [[page="" 45405]]="" federalism="" effects="" due="" to="" the="" migratory="" nature="" of="" certain="" species="" of="" birds,="" the="" federal="" government="" has="" been="" given="" responsibility="" over="" these="" species="" by="" the="" migratory="" bird="" treaty="" act.="" these="" rules="" do="" not="" have="" a="" substantial="" direct="" effect="" on="" fiscal="" capacity,="" change="" the="" roles="" or="" responsibilities="" of="" federal="" or="" state="" governments,="" or="" intrude="" on="" state="" policy="" or="" administration.="" therefore,="" in="" accordance="" with="" executive="" order="" 12612,="" these="" regulations="" do="" not="" have="" significant="" federalism="" effects="" and="" do="" not="" have="" sufficient="" federalism="" implications="" to="" warrant="" the="" preparation="" of="" a="" federalism="" assessment.="" government-to-government="" relationship="" with="" tribes="" in="" accordance="" with="" the="" president's="" memorandum="" of="" april="" 29,="" 1994,="" ``government-to-government="" relations="" with="" native="" american="" tribal="" governments''="" (59="" fr="" 22951)="" and="" 512="" dm="" 2,="" we="" have="" evaluated="" possible="" effects="" on="" federally="" recognized="" indian="" tribes="" and="" have="" determined="" that="" there="" are="" no="" effects.="" authorship.="" the="" primary="" author="" of="" this="" rule="" is="" james="" r.="" kelley,="" jr.,="" office="" of="" migratory="" bird="" management.="" list="" of="" subjects="" in="" 50="" cfr="" part="" 20="" exports,="" hunting,="" imports,="" reporting="" and="" recordkeeping="" requirements,="" transportation,="" wildlife.="" accordingly,="" we="" are="" amending="" part="" 20,="" subchapter="" b,="" chapter="" 1="" of="" title="" 50="" of="" the="" code="" of="" federal="" regulations="" as="" follows:="" part="" 20--[amended]="" 1.="" the="" authority="" citation="" for="" part="" 20="" continues="" to="" read="" as="" follows:="" authority:="" 16="" u.s.c.="" 703-712="" and="" 16="" u.s.c.="" 742="" a-j.="" 2.="" section="" 20.21="" is="" amended="" by="" revising="" paragraph="" (j)="" introductory="" text,="" revising="" paragraphs="" (j)(2)="" and="" (j)(3),="" and="" removing="" paragraph="" (j)(4)="" as="" follows:="" 20.21="" what="" hunting="" methods="" are="" illegal?="" *="" *="" *="" *="" *="" (j)="" while="" possessing="" shot="" (either="" in="" shotshells="" or="" as="" loose="" shot="" for="" muzzleloading)="" other="" than="" steel="" shot,="" or="" bismuth-tin="" (97="" parts="" bismuth:="" 3="" parts="" tin="" with=""><1 percent="" residual="" lead)="" shot,="" or="" tungsten-="" iron="" (40="" parts="" tungsten:="" 60="" parts="" iron="" with=""><1 percent="" residual="" lead)="" shot,="" or="" tungsten-polymer="" (95.5="" parts="" tungsten:="" 4.5="" parts="" nylon="" 6="" or="" 11="" with=""><1 percent="" residual="" lead)="" shot,="" or="" tungsten-matrix="" (95.9="" parts="" tungsten:="" 4.1="" parts="" polymer="" with=""><1 percent="" residual="" lead)="" shot,="" or="" tin="" (99.9="" percent="" tin="" with=""><1 percent="" residual="" lead)="" shot,="" or="" such="" shot="" approved="" as="" nontoxic="" by="" the="" director="" pursuant="" to="" procedures="" set="" forth="" in="" 20.134,="" provided="" that:="" *="" *="" *="" *="" *="" (2)="" tungsten-matrix="" shot="" (95.9="" parts="" tungsten:="" 4.1="" parts="" polymer="" with=""><1 percent="" residual="" lead)="" is="" legal="" as="" nontoxic="" shot="" for="" waterfowl="" and="" coot="" hunting="" for="" the="" 1999-2000="" hunting="" season="" only,="" and="" (3)="" tin="" shot="" (99.9="" percent="" tin="" with=""><1 percent="" residual="" lead)="" is="" legal="" as="" nontoxic="" shot="" for="" waterfowl="" and="" coot="" hunting="" for="" the="" 1999-2000="" hunting="" season="" only.="" dated:="" august="" 12,="" 1999.="" stephen="" c.="" saunders,="" acting="" assistant="" secretary="" for="" fish="" and="" wildlife="" and="" parks.="" [fr="" doc.="" 99-21525="" filed="" 8-18-99;="" 8:45="" am]="" billing="" code="" 4310-55-p="">