[Federal Register Volume 64, Number 116 (Thursday, June 17, 1999)]
[Proposed Rules]
[Pages 32752-32756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15339]
[[Page 32751]]
_______________________________________________________________________
Part VII
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; Proposed Rule
Federal Register / Vol. 64, No. 116 / Thursday, June 17, 1999 /
Proposed Rules
[[Page 32752]]
DEPARTMENT OF THE 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: Proposed rule.
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SUMMARY: The U.S. Fish and Wildlife Service (Service or we) proposes to
grant final approval of tungsten-iron and tungsten-polymer shots as
nontoxic for hunting waterfowl and coots. We also propose to 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: Comments on the proposed rule must be received no later than
July 19, 1999.
ADDRESSES: Comments may be sent to the Chief, Office of Migratory Bird
Management (MBMO), U.S. Fish and Wildlife Service, 1849 C Street, NW.,
ms 634-ARLSQ, Washington, DC 20240. The public may inspect comments
during normal business hours in room 634, Arlington Square Building,
4401 N. Fairfax Drive, Arlington, Virginia.
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 55 percent tungsten and 45 percent iron, by
weight, and has a density of approximately 10.3 g/cm3.
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/cm3 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/cm3 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/
cm3 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/cm3, 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 environments. Tungsten is very
stable
[[Page 32753]]
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 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
[[Page 32754]]
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 for 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 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.
[[Page 32755]]
The second condition for 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="" for="" 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.="" this="" proposed="" rule="" would="" amend="" 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.="" we="" also="" propose="" to="" grant="" temporary="" approval="" to="" tungsten-matrix="" and="" tin="" shots="" for="" the="" 1999-2000="" hunting="" season="" only.="" temporary="" approval="" would="" be="" based="" on="" the="" toxicological="" reports="" and="" acute="" toxicity="" studies="" submitted="" by="" kent="" and="" itri.="" we="" have="" reduced="" the="" public="" comment="" period="" from="" 60="" days="" to="" 30="" days="" in="" order="" to="" complete="" the="" rulemaking="" process="" prior="" to="" the="" start="" of="" the="" hunting="" season.="" this="" will="" facilitate="" planning="" efforts="" by="" vendors="" and="" state="" wildlife="" agencies.="" 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.="" 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="" draft="" environmental="" assessments="" (ea)="" in="" may,="" 1999.="" the="" eas="" are="" available="" to="" the="" public="" at="" the="" location="" indicated="" under="" the="" addresses="" caption.="" 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="" are="" completing="" a="" section="" 7="" consultation="" under="" the="" esa="" for="" this="" proposed="" rule.="" the="" result="" of="" our="" consultation="" under="" section="" 7="" of="" the="" esa="" will="" be="" available="" to="" the="" public="" at="" the="" location="" indicated="" under="" the="" addresses="" caption.="" [[page="" 32756]]="" regulatory="" flexibility="" act="" the="" regulatory="" flexibility="" act="" of="" 1980="" (5="" u.s.c.="" 601="" et="" seq.)="" requires="" the="" preparation="" of="" flexibility="" analyses="" for="" rules="" that="" will="" have="" a="" significant="" effect="" on="" a="" substantial="" number="" of="" small="" entities,="" which="" includes="" small="" businesses,="" organizations="" or="" governmental="" jurisdictions.="" this="" rule="" would="" approve="" additional="" types="" of="" nontoxic="" shot="" that="" may="" be="" sold="" and="" used="" to="" hunt="" migratory="" birds;="" this="" rule="" would="" provide="" 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="" shot="" merely="" will="" supplement="" nontoxic="" shot="" already="" in="" commerce="" and="" available="" throughout="" the="" retail="" and="" wholesale="" distribution="" systems.="" we="" anticipate="" no="" dislocation="" or="" other="" local="" effects,="" with="" regard="" to="" hunters="" and="" others.="" this="" rule="" was="" not="" subject="" to="" office="" of="" management="" and="" budget="" (omb)="" review="" under="" executive="" order="" 12866.="" 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?="" section="" 20.21="" may="" be="" written="" in="" plain="" language="" format="" in="" the="" final="" rule.="" 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.="" 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="" proposed="" 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="" propose="" to="" amend="" part="" 20,="" subchapter="" b,="" chapter="" 1="" of="" title="" 50="" of="" the="" code="" of="" federal="" regulations="" as="" follows:="" part="" 20--[amended]="" 1.="" the="" authority="" citation="" for="" part="" 20="" continues="" to="" read="" as="" follows:="" authority:="" 16="" u.s.c.="" 703-712="" and="" 16="" u.s.c.="" 742="" a-j.="" 2.="" section="" 20.21="" is="" amended="" by="" revising="" the="" section="" title,="" revising="" paragraph="" (j)="" introductory="" text,="" revising="" paragraphs="" (j)(2)="" and="" (j)(3),="" and="" removing="" paragraph="" (j)(4)="" to="" read="" 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="" (55="" parts="" tungsten:="" 45="" 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="" sec.="" 20.134,="" provided="" that:="" (1)="" *="" *="" *="" (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:="" june="" 8,="" 1999.="" stephen="" c.="" saunders,="" acting="" assistant="" secretary="" for="" fish="" and="" wildlife="" and="" parks.="" [fr="" doc.="" 99-15339="" filed="" 6-16-99;="" 8:45="" am]="" billing="" code="" 4310-55-p="">