[Federal Register Volume 63, Number 233 (Friday, December 4, 1998)]
[Proposed Rules]
[Pages 67037-67039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32236]
[[Page 67037]]
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DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 20
RIN 1018-AE39
Migratory Bird Hunting; Temporary Conditional Approval of Tin
Shot as Nontoxic for the 1998-99 Season
AGENCY: Fish and Wildlife Service, Interior.
ACTION: Proposed rule.
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SUMMARY: The U.S. Fish and Wildlife Service (Service) proposes to amend
Section 20.21(j) and grant temporary and conditional approval of tin
shot as nontoxic for the 1998-99 migratory bird hunting season while
chronic toxicity/reproductive testing is being completed. Tin shot has
been submitted for consideration as nontoxic by the International Tin
Research Institute, Ltd. (ITRI), of Uxbridge, Middlesex, Great Britain.
DATES: Comments on the proposed rule or draft Environmental Assessment
(EA) (see caption NEPA CONSIDERATION) must be received no later than
January 4, 1999.
ADDRESSES: Copies of the EA are available by writing 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.
Comments may also be forwarded to this same address. 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: Robert J. Blohm, Acting Chief, or
James R. Kelley, Jr., Wildlife Biologist, Office of Migratory Bird
Management (MBMO), (703) 358-1714.
SUPPLEMENTARY INFORMATION: Since the mid-1970s, the Service has 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 by the Service as nontoxic. Tungsten-iron and
tungsten-polymer shot have been given temporary conditional approval
for the 1998-99 hunting season. Compliance with the use of nontoxic
shot has been increasing over the last few years. The Service believes
that this level of compliance will continue to increase with the
availability and approval of other nontoxic shot types. The Service is
eager to consider these other materials for approval as nontoxic shot.
The revised procedures for approving nontoxic shot (50 CFR 20.134)
consist of a three-tier process whereby existing information can
minimize the need for full testing of a candidate shot. However,
applicants still carry the burden of proving that the candidate shot is
nontoxic. By developing the new approval procedure, it was the
Service's intent to discontinue the practice of granting temporary
conditional approval to candidate shot material. However, the
application by ITRI was initiated prior to implementation of the new
protocol. To date, scientific information presented in the application
suggests that tin is nontoxic under conditions for the proposed shot
configuration. Therefore, the Service proposes to grant temporary
conditional approval for the 1998-99 hunting season. Permanent approval
will not be granted until chronic toxicity/reproductive testing is
successfully completed and the results are reviewed and approved by the
Director.
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. The shot material has a density of
approximately 7.29 g/cm3. The shot is 99.97 percent tin,
with a low level of iron pickup due to the steel production equipment.
ITRI's application includes a statement of proposed use, a
description of the new tin shot, a toxicological report (Thomas 1997),
and results of a 30-day dosing study of the toxicity of the candidate
shot in game-farm mallards (Wildlife International, Ltd. 1998). The
toxicological report 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), effects of firing on tin shot,
and information on environmental fate and transport. The toxicity study
is a 30-day dosing test to determine if the candidate shot poses any
deleterious effects to game-farm mallards. This will meet the
requirements for Tier 2, as described in 50 CFR 20.134(b)(3).
Toxicity Information
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, which is the material used in this
shot, 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.
Environmental Fate and Transport
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 Concentrations
Calculation of the estimated environmental concentration (EEC) of
tin in a terrestrial ecosystem is based on 69,000 shot per hectare
(Pain 1990). The EEC for tin in soil is 19.3 g/m3.
Calculation of the EEC in an aquatic ecosystem assumes complete erosion
of the shot in one cubic foot of water. The EEC in water for tin is
19.3 mg/L. Tin shot is considered insoluble and is stable in basic,
neutral, and mildly acidic environments. Therefore, erosion is expected
to be minimal, and adverse effects on biota are not expected to occur.
Effects on Birds
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.
Ringelman et al. (1993) 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. Blood calcium differences between
dosed and un-dosed birds were judged to be unrelated to shot exposure.
This study concluded that ``. . . TBT shot presents virtually no
potential for acute intoxication in mallards under the conditions of
this study.''
Kraabel et al. (1996) surgically embedded TBT shot in the
pectoralis muscles of ducks to simulate wounding by gunfire and to test
for toxic effects of
[[Page 67038]]
the shot. These authors found that TBT shot produced no toxic effects
nor induced any adverse systemic effects on the health of ducks during
the 8-week period.
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. 1997).
The studies cited above summarize the available published
information on shot types in which tin is a component. However, these
studies involve either short-term acute toxicity tests, or shot
compositions in which tin is a minor component. Additional information
is needed to fully assess the toxicity of tin shot.
ITRI's 30-day dosing study (Wildlife International Ltd., 1998) with
the candidate shot 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 TM; 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.
Based on the results of the toxicological report and the toxicity
test (Tier 1 and 2), the Service concludes that tin shot,
(approximately 99.9 percent tin by weight with <1 percent="" residual="" lead),="" does="" not="" appear="" to="" pose="" a="" significant="" danger="" to="" migratory="" birds="" or="" other="" wildlife="" and="" their="" habitats.="" however,="" the="" service="" is="" concerned="" that="" available="" information="" on="" the="" effect="" of="" tin="" on="" reproduction="" in="" birds="" is="" based="" on="" shot="" alloys="" in="" which="" tin="" is="" a="" small="" component.="" therefore,="" effects="" of="" the="" candidate="" shot="" on="" reproduction="" in="" birds="" is="" relatively="" unknown.="" the="" first="" condition="" of="" approval="" is="" toxicity="" testing.="" candidate="" materials="" not="" approved="" under="" tier="" 1="" and/or="" 2="" testing="" are="" subjected="" to="" standards="" of="" tier="" 3="" testing.="" the="" scope="" of="" tier="" 3="" includes="" chronic="" exposure="" under="" adverse="" environmental="" conditions="" and="" effects="" on="" reproduction="" in="" game-farm="" mallards,="" as="" outlined="" in="" 50="" cfr="" 20.134="" (b)(4)(a="" and="" b)="" (tier="" 3),="" and="" in="" consultation="" with="" the="" service's="" office="" of="" migratory="" bird="" management="" and="" the="" u.s.="" geological="" survey's="" division="" of="" biological="" resources.="" this="" study="" includes="" assessment="" of="" long-term="" toxicity="" under="" depressed="" temperature="" conditions="" using="" a="" nutritionally-="" deficient="" diet,="" as="" well="" as="" a="" moderately="" long-term="" study="" that="" includes="" reproductive="" assessment.="" the="" tests="" require="" the="" applicant="" to="" demonstrate="" that="" tin="" shot="" is="" nontoxic="" to="" waterfowl="" and="" their="" offspring.="" the="" second="" condition="" of="" final="" unconditional="" approval="" is="" testing="" for="" residual="" lead="" levels.="" any="" tin="" shot="" with="" lead="" levels="" equal="" to="" or="" exceeding="" 1="" percent="" will="" be="" considered="" toxic="" and,="" therefore,="" illegal.="" in="" the="" federal="" register="" of="" august="" 18,="" 1995="" (60="" fr="" 43314),="" the="" service="" indicated="" that="" it="" would="" establish="" a="" maximum="" level="" for="" residual="" lead.="" the="" service="" has="" determined="" that="" the="" maximum="" environmentally="" acceptable="" level="" of="" lead="" in="" any="" nontoxic="" shot="" is="" trace="" amounts="" of=""><1 percent="" and="" has="" incorporated="" this="" requirement="" (50="" cfr="" 20.134(b)(5))="" in="" the="" december="" 1,="" 1997,="" final="" rule="" (62="" fr="" 63608).="" itri="" documented="" that="" tin="" shot="" had="" no="" residual="" lead="" levels="" equal="" to="" or="" exceeding="" 1="" percent.="" the="" third="" condition="" of="" final="" unconditional="" approval="" involves="" enforcement.="" in="" the="" august="" 18,="" 1995="" federal="" register="" (60="" fr="" 43314),="" the="" service="" indicated="" that="" final="" unconditional="" approval="" of="" any="" nontoxic="" shot="" would="" be="" contingent="" upon="" the="" development="" and="" availability="" of="" a="" noninvasive="" field="" testing="" device.="" several="" noninvasive="" field="" testing="" devices="" are="" under="" development="" to="" separate="" tin="" shot="" from="" lead="" shot.="" furthermore,="" tin="" shot="" can="" be="" drawn="" to="" a="" magnet="" as="" a="" simple="" field="" detection="" method.="" this="" requirement="" was="" incorporated="" into="" regulations="" at="" 50="" cfr="" 20.134(b)(6)="" in="" the="" december="" 1,="" 1997,="" final="" rule="" (62="" fr="" 63608).="" this="" proposed="" rule="" would="" amend="" 50="" cfr="" 20.21(j)="" by="" temporarily="" and="" conditionally="" approving="" tin="" shot="" as="" nontoxic="" for="" the="" 1998-99="" migratory="" bird="" hunting="" season="" throughout="" the="" united="" states.="" it="" is="" based="" on="" the="" request="" made="" to="" the="" service="" by="" itri="" on="" november="" 17,="" 1997,="" the="" toxicological="" reports,="" and="" the="" acute="" toxicity="" studies.="" results="" of="" the="" toxicological="" report="" and="" 30-day="" toxicity="" test="" undertaken="" for="" itri="" indicate="" the="" apparent="" absence="" of="" any="" deleterious="" effects="" of="" tin="" shot="" when="" ingested="" by="" captive-reared="" mallards="" or="" to="" the="" ecosystem.="" the="" comment="" period="" for="" the="" proposed="" rule="" has="" been="" shortened="" to="" 30="" days.="" this="" time="" frame="" will="" make="" it="" possible="" for="" tin="" shot,="" if="" temporarily="" approved,="" to="" be="" available="" for="" use="" by="" hunters="" during="" the="" 1998-99="" hunting="" season.="" this="" will="" increase="" the="" number="" of="" nontoxic="" shot="" options="" available="" to="" hunters.="" literature="" cited="" 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,="" dc="" 85="" pp.="" 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.="" 32:483-488.="" huntingdon="" research="" centre="" ltd.="" 1987.="" the="" effects="" of="" dosing="" mallard="" ducks="" with="" safe="" shot.="" huntingdon,="" cambridge,="" u.k.="" report="" dated="" dec.="" 19,="" 1987.="" 15pp.="" hoiland,="" k.="" 1995.="" reaction="" of="" some="" decomposer="" basidiomycetes="" to="" toxic="" elements.="" nordic="" j.="" bot.="" 15:305-318.="" 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.="" 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.="" 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.="" 1997.="" 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.="" 1997.="" 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.="" wildlife="" international,="" ltd.="" 1998.="" tin="" shot:="" an="" oral="" toxicity="" study="" with="" the="" mallard.="" project="" no.="" 476-101.="" 158="" pp.="" [[page="" 67039]]="" nepa="" consideration="" in="" compliance="" with="" the="" requirements="" of="" section="" 102(2)(c)="" of="" the="" national="" environmental="" policy="" act="" of="" 1969="" (nepa)="" (42="" u.s.c.="" 4332(c)),="" and="" the="" council="" on="" environmental="" quality's="" regulation="" for="" implementing="" nepa="" (40="" cfr="" 1500-1508),="" the="" service="" prepared="" an="" environmental="" assessment="" (ea)="" in="" october="" 1998.="" this="" ea="" is="" available="" to="" the="" public="" for="" comment="" 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,="" ``the="" secretary="" shall="" review="" other="" programs="" administered="" by="" him="" and="" utilize="" such="" programs="" in="" furtherance="" of="" the="" purposes="" of="" this="" act''="" (and)="" 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="" *="" *="" *''="" the="" service="" has="" initiated="" a="" section="" 7="" consultation="" under="" the="" esa="" for="" this="" proposed="" rule.="" the="" result="" of="" the="" service's="" consultation="" under="" section="" 7="" of="" the="" esa="" will="" be="" available="" to="" the="" public="" at="" the="" location="" indicated="" under="" the="" addresses="" caption.="" regulatory="" flexibility="" act,="" executive="" order="" 12866,="" and="" the="" paperwork="" reduction="" 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.="" the="" department="" of="" the="" interior="" certifies="" that="" this="" document="" will="" not="" have="" a="" significant="" economic="" effect="" on="" a="" substantial="" number="" of="" small="" entities="" under="" the="" regulatory="" flexibility="" act.="" the="" approved="" shot="" will="" merely="" supplement="" nontoxic="" shot="" already="" in="" commerce="" and="" available="" throughout="" the="" retail="" and="" wholesale="" distribution="" systems,="" therefore,="" this="" rule="" would="" have="" minimal="" effect="" on="" such="" entities.="" the="" service="" anticipates="" no="" dislocation="" or="" other="" local="" effects="" with="" regard="" to="" hunters="" and="" others.="" this="" document="" is="" not="" a="" significant="" rule="" subject="" to="" office="" of="" management="" and="" budget="" review="" under="" executive="" order="" 12866.="" this="" rule="" does="" not="" contain="" collections="" of="" information="" that="" require="" approval="" by="" the="" office="" of="" management="" and="" budget="" under="" 44="" u.s.c.="" 3501="" et="" seq.="" unfunded="" mandates="" reform="" the="" service="" has="" determined="" and="" certifies="" 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="" the="" department="" has="" determined="" that="" these="" proposed="" regulations="" meet="" the="" applicable="" standards="" provided="" in="" sections="" 3(a)="" and="" 3(b)(2)="" of="" executive="" order="" 12988.="" 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="" record-keeping="" requirements,="" transportation,="" wildlife.="" accordingly,="" part="" 20,="" subchapter="" b,="" chapter="" 1="" of="" title="" 50="" of="" the="" code="" of="" federal="" regulations="" is="" proposed="" to="" be="" amended="" 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,="" and="" adding="" paragraph="" (j)(5)="" to="" read="" as="" follows:="" sec.="" 20.21="" hunting="" methods.="" *="" *="" *="" *="" *="" (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="" ([nominally]="" 40="" parts="" tungsten:="" 60="" parts="" iron="" with=""><1 percent="" residual="" lead)="" shot,="" or="" tungsten-polymer="" (95.5="" parts="" tungsten:="" 4.5="" parts="" nylon="" 6="" 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:="" *="" *="" *="" *="" *="" (5)="" tin="" shot="" (99.9="" percent="" tin="" with=""><1 percent="" residual="" lead)="" is="" legal="" as="" nontoxic="" shot="" for="" waterfowl="" and="" coot="" hunting="" for="" the="" 1998-1999="" hunting="" season="" only.="" dated:="" november="" 17,="" 1998.="" stephen="" c.="" saunders,="" acting="" assistant="" secretary="" for="" fish="" and="" wildlife="" and="" parks.="" [fr="" doc.="" 98-32236="" filed="" 12-3-98;="" 8:45="" am]="" billing="" code="" 4310-55-p="">