[Federal Register Volume 63, Number 143 (Monday, July 27, 1998)]
[Proposed Rules]
[Pages 40077-40080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19891]
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DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 20
RIN 1018-AE35
Migratory Bird Hunting; Extension of Temporary Approval of
Tungsten-Iron 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) is proposing to
amend Section 20.21(j) to grant temporary approval of tungsten-iron
shot as nontoxic for the 1998-99 migratory bird hunting season, except
in the Yukon-Kuskokwim (Y-K) Delta, Alaska. The Service had previously
granted temporary approval of tungsten-iron shot as nontoxic for the
1997-98 season. The toxicological report, which is an extensive
literature search and analysis of tungsten and tungsten-iron, suggests
that these compounds are nontoxic under assumed use and in the
environment. Analysis of the toxicity study reveal no adverse effects
over a 30-day period when dosing mallards (Anas platyrhynchos) with 8
BB size tungsten-iron shot. However, there is some concern that the
absorption of tungsten into the femur, kidney, and liver could
potentially affect the spectacled eider (Somateria fischeri), a species
already subject to adverse weather, predation, and lead poisoning on
the Y-K Delta. Until a reproductive/chronic toxicity test has been
completed and the Service has reviewed the results, tungsten, iron shot
will not be approved for the Y-K Delta.
DATES: Comments on the proposed rule must be received no later than
August 26, 1998.
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., room 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: Paul R. Schmidt, Chief, Office of
Migratory Bird Management, (703) 358-1714.
SUPPLEMENTARY INFORMATION: Since the mid-1970s, the Service has sought
to identify shot that, when spent, does not pose a significant toxic
hazard to migratory birds and other wildlife. The
[[Page 40078]]
Service established procedures and requirements for approval of shot
and shot coatings as nontoxic in 1986 and published them in 50 CFR
20.134. The Service adopted new procedures in December 1997. These are
published at 50 CFR 20.134. Currently, only steel shot and bismuth-tin
shot are approved by the Service as nontoxic shot. The Service granted
temporary approval of bismuth-tin as nontoxic on two separate actions
for the hunting seasons of 1994-95 and 1995-96. Tungsten-iron shot was
given temporary approval for the 1997-98 migratory bird hunting season
(62 FR 43444 published August 18, 1997). The Service believes approval
for other suitable candidate shot materials as nontoxic is feasible.
Compliance with the use of nontoxic shot is 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.
Federal Cartridge Company's (Anoka, Minnesota) candidate shot is
made from sintering tungsten and iron, which together forms a two-phase
alloy. Shot made from this material has a density of approximately 10.3
g/cc or 94 percent of the density of lead. The shot will contain
nominally 55 percent tungsten and 45 percent iron, by weight. The
pellet will have sufficient iron to attract a magnet.
Federal's application includes a description of the new tungsten-
iron shot, a toxicological report, and results of a 30-day dosing study
to assess the toxicity of this shot in game-farm mallards (Anas
platyrhynchos). The toxicological report incorporates toxicity
information (a synopsis of acute and chronic toxicity data for birds,
acute effects on mammals, potential for environmental concern, toxicity
to aquatic and terrestrial invertebrates, amphibians and reptiles), and
information on environmental fate and transport (shot alteration,
environmental half-life, and environmental concentration). The toxicity
study is a 30-day dosing test to determine if the candidate shot poses
any deleterious effects to game farm mallards. This meets the
requirements of Tier 1 and Tier 2, 50 CFR Sec. 20.134(b)(2) and
(b)(3)(B).
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, therefore, are expected to be nontoxic.
After completion of the literature review, there appears to be no known
basis for concern of toxicity to wildlife for the candidate shot
material (metallic tungsten and iron) via ingestion by fish, birds, or
mammals (Bursian et al., 1996; Gigiena, 1983; Patty, 1981; Industrial
Medicine, 1946; Karantassis, 1924). However, there is some concern that
the absorption of tungsten into the femur, kidney, and liver could
potentially affect certain endangered or threatened species such as the
spectacled eider (Somateria fischeri) on the Y-K Delta, Alaska. Until a
reproductive/chronic toxicity test has been completed and the Service
has reviewed the results, tungsten-iron shot will not be approved for
the Y-K Delta.
Environmental Fate and Transport
Tungsten is insoluble in water and, therefore, not mobile in
hypergenic 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-Peddias, 1984).
Environmental Concentration
Calculation of the environmental concentration (EEC) for a
terrestrial ecosystem is on 69,000 shot per hectare (Pain 1990),
assuming complete erosion of material in 5 cm of soil. The EEC for
tungsten in soil is 32.9 mg/kg for a shot composition of 62.9 percent
tungsten-iron alloy, 11.87 percent tungsten, and 25.31 percent iron.
Adverse effects on biota are not expected to occur for shot components,
given the Hazard Quotients (HQs).
Environmental Concentration
Calculation of the environmental concentration (EEC) for an aquatic
ecosystem assumes complete erosion of the shot in one cubic foot of
water. The EEC in water for tungsten was 10.5 mg/L for a shot
composition of 62.9 percent tungsten-iron alloy, 11.87 percent
tungsten, and 25.31 percent iron. Given these HQs, adverse effects on
biota are not expected to occur for shot components.
An extensive literature search and review provides information on
the toxicity of elemental tungsten to waterfowl and other birds. In
Ringelman et al. (1993) effects of ingested tungsten-bismuth-tin shot
(TBT) on captive mallards saw no acute toxicity. Orally dosing 20 8-
week-old game farm mallards with 12 to 17 pellets (1.03g) TBT and
monitoring for 32 days for evidence of intoxication saw no effect. No
birds died during the trial. Gross lesions were not observed during the
postmortem examination. Histopathological examination did not reveal
any evidence of toxicity or tissue damage. Tungsten was not detectable
in kidney or liver samples. The author's conclusion is that TBT shot
presents virtually no potential for acute intoxication in mallards.
A study by Kraabel et al. (1996) assesses the effects of embedded
tungsten-bismuth-tin shot on mallards. The authors' conclusion was that
TBT is not acutely toxic when implanted in mallard muscle tissue.
Inflammatory reactions to TBT shot were localized, and had no
detectable systemic effects on mallard health.
Nell (1981) fed laying hens 0.4 or 1 g/kg tungsten in a commercial
mash for five months to assess the reproductive performance. Weekly egg
production was normal and hatchability of fertile eggs was not
affected.
Large doses of tungsten given to chickens (Gallus domesticus)
either through injection or by feeding saw an increase in tissue
concentration of tungsten and a decreased tissue concentration of
molybdenum (Nell, 1981). The loss rate of tungsten from the liver
occurred in an exponential manner with a half-life of 27 hours. The
alterations in molybdenum metabolism seem to identify with tungsten and
not of molybdenum deficiency. Death due to tungsten occurred when
tissue concentrations were increased to 25 mg/g liver. At this
concentration, the activity of xanthine dehydrogenase was zero.
In Federal's 30-day dosing study 8 male and 8 female adult mallards
given 8 No. 4 steel shot, 8 No. 4 lead shot or 8 BB's of tungsten-iron
were observed over a 30-day period. An additional 8 males and 8 females
were given no shot. All tungsten-iron birds survived the test with a
slight increase in body weight. There were no changes in hematocrit,
hemoglobin concentration, and ALAD activity, as well as 25 plasma
chemistry parameters. Five of the 16 tungsten-iron birds had a mild
hepatocellular biliary stasis, but the authors felt this was not
remarkable. No other histopathological lesions were found. In general,
no adverse effects were seen when mallards were given 8 BB size
tungsten-iron shot and monitored over a 30-day period. 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. Alteration of body weights is not significant in any of the
treatments, although lead-dosed birds which died during the trial lost
an average of 30 percent of their body weight.
[[Page 40079]]
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 in comparison to the other three groups. There were no
significant differences in these whole-blood parameters at day 30.
As a result of the toxicological report and toxicity test, the
Service concludes at this time that the available information indicates
that tungsten-iron shot, nominally 40-55 percent tungsten and 60-45
percent iron, by weight with <1 percent="" residual="" lead,="" does="" not="" impose="" significant="" danger="" to="" migratory="" birds="" and="" other="" wildlife="" and="" their="" habitats,="" but="" that="" reproductive/chronic="" toxicity="" data="" is="" lacking.="" lacking="" sufficient="" reproductive/chronic="" toxicity="" data="" on="" the="" candidate="" shot,="" the="" applicant="" was="" advised="" to="" conduct="" additional="" testing="" as="" described="" in="" tier="" 2="" and="" tier="" 3="" as="" outlined="" in="" 50="" cfr="" 20.134="" (b)(3)="" and="" (4),="" and="" in="" consultation="" with="" the="" service's="" office="" of="" migratory="" bird="" management="" and="" the="" u.s.="" geological="" survey's="" division="" of="" biological="" resources="" (brd).="" one="" test="" includes="" assessment="" of="" reproduction,="" fertility="" rates,="" and="" egg="" hatchability="" (egg="" weight,="" shell="" thickness,="" and="" content="" analysis).="" the="" test="" requires="" the="" applicant="" to="" demonstrate="" that="" tungsten-iron="" shot="" is="" nontoxic="" to="" waterfowl="" and="" their="" offspring.="" the="" service's="" maximum="" environmentally="" acceptable="" level="" of="" residual="" lead="" in="" shot="" is="" trace="" amounts="" of=""><1 percent="" (50="" cfr="" 20.134="" (b)="" (5)).="" the="" service="" will="" consider="" any="" tungsten-iron="" shot="" manufactured="" with="" lead="" levels="" equal="" to="" or="" exceeding="" 1="" percent="" as="" toxic="" and,="" therefore,="" illegal.="" at="" this="" time,="" the="" tungsten-iron="" shot="" meets="" the="" acceptable="" specifications.="" before="" approval="" of="" any="" shot="" for="" use="" in="" migratory="" game="" bird="" hunting,="" a="" noninvasive="" field="" testing="" device="" must="" be="" available="" for="" enforcement="" officers="" to="" determine="" the="" shot="" material="" in="" a="" given="" shell="" in="" the="" field="" (50="" cfr="" 20.134="" (b)(6)).="" several="" noninvasive="" field="" testing="" devices="" are="" under="" development="" to="" separate="" tungsten-iron="" shot="" from="" lead="" shot.="" tungsten-iron="" shot="" can="" be="" drawn="" to="" a="" magnet="" as="" a="" simple="" field="" detection="" method.="" in="" summary,="" this="" proposed="" rule="" would="" amend="" 50="" cfr="" 20.21(j)="" by="" extending="" temporary="" approval="" of="" tungsten-iron="" shot="" as="" nontoxic="" for="" the="" 1998-99="" migratory="" bird="" hunting="" season,="" except="" in="" the="" y-k="" delta,="" alaska.="" it="" is="" based="" on="" the="" original="" request="" made="" to="" the="" service="" by="" federal="" cartridge="" company="" on="" august="" 20,="" 1996,="" the="" toxicological="" report,="" and="" acute="" toxicity="" study="" reviewed="" by="" the="" service="" in="" its="" initial="" decision="" to="" grant="" temporary="" approval="" for="" the="" 1997-98="" season="" (62="" fr="" 43444).="" results="" of="" the="" toxicological="" report="" and="" 30-day="" toxicity="" test="" undertaken="" for="" federal="" cartridge="" company="" document="" the="" apparent="" absence="" of="" any="" deleterious="" effects="" of="" tungsten-iron="" shot="" when="" ingested="" by="" captive-="" reared="" mallards="" or="" to="" the="" ecosystem.="" information="" since="" the="" service's="" initial="" decision="" has="" not="" changed="" or="" been="" supplemented="" to="" date.="" a="" reproductive/chronic="" toxicity="" test="" will="" be="" completed="" and="" the="" service="" will="" review="" the="" results,="" prior="" to="" any="" final="" unconditional="" approval="" of="" tungsten-iron="" shot="" for="" migratory="" bird="" hunting.="" references="" barr="" engineering="" company.="" 1996.="" toxicology="" report="" on="" new="" shot.="" contract="" report="" 2302118/40970-1/cet.="" 21="" pp.="" bursian,="" s.="" j.,="" m.="" e.="" kelly,="" r.="" j.="" aulerich,="" d.="" c.="" powell,="" and="" s.="" fitzgerald.="" 1996.="" thirty-day="" dosing="" test="" to="" assess="" the="" toxicity="" of="" tungsten-iron="" shot="" in="" game-farm="" mallards.="" 1996.="" report="" to="" federal="" cartridge="" co.="" 77="" pp.="" gigiema="" i.="" sanitariya.="" 1983.="" mezhdunarodnaya="" kniga.="" moscow,="" ussr.="" 48(7):77.="" 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.="" interagency="" ecosystem="" management="" task="" force.="" 1995.="" the="" ecosystem="" approach:="" healthy="" ecosystems="" and="" sustainable="" economics.="" volume="" ii-="" implementation="" issues.="" kabata-peddias,="" 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.="" 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.="" 1981.="" wiley="" interscience.="" wiley="" &="" sons,="" inc.="" ny,="" ny.="" third="" ed.="" 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.="" 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),="" the="" service="" prepared="" an="" environmental="" assessment="" (ea)="" in="" may,="" 1998.="" this="" ea="" is="" available="" to="" the="" public="" at="" the="" location="" indicated="" under="" the="" addresses="" caption.="" based="" on="" review="" and="" evaluation="" of="" the="" information="" in="" the="" ea,="" the="" service="" has="" determined="" that="" amending="" 50="" cfr="" 20.21(j)="" to="" extend="" temporary="" approval="" of="" tungsten-iron="" shot="" as="" nontoxic="" for="" the="" 1998-99="" migratory="" bird="" hunting="" season="" 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="" .="" .="" .''="" the="" service="" has="" completed="" a="" section="" 7="" consultation="" under="" the="" esa="" for="" this="" rule="" and="" determined="" that="" granting="" temporary="" approval="" of="" tungsten-iron="" shot="" for="" the="" 1998-99="" hunting="" season,="" except="" on="" the="" yukon-kuskokwin="" (y-k)="" delta,="" is="" not="" likely="" to="" affect="" any="" threatened,="" endangered,="" proposed="" or="" candidate="" species.="" the="" result="" of="" the="" service's="" consultation="" under="" section="" 7="" of="" the="" esa="" is="" 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="" economic="" impacts="" of="" annual="" hunting="" on="" small="" business="" entities="" were="" analyzed="" in="" detail="" and="" a="" small="" entity="" flexibility="" analysis="" (analysis),="" under="" the="" regulatory="" flexibility="" act="" (5="" u.s.c.="" 601,="" et="" seq.),="" was="" issued="" by="" the="" service="" in="" 1996="" (copies="" available="" upon="" request="" from="" the="" office="" of="" migratory="" bird="" management).="" the="" analysis="" documented="" the="" significant="" beneficial="" economic="" effect="" on="" a="" substantial="" number="" of="" small="" entities.="" the="" primary="" source="" of="" information="" about="" hunter="" expenditures="" for="" migratory="" game="" bird="" hunting="" is="" the="" national="" hunting="" and="" fishing="" survey,="" which="" is="" conducted="" at="" 5-year="" intervals.="" the="" analysis="" utilized="" the="" 1991="" national="" hunting="" and="" fishing="" survey="" and="" the="" u.s.="" department="" of="" commerce's="" county="" business="" patterns="" from="" which="" it="" was="" [[page="" 40080]]="" estimated="" that="" migratory="" bird="" hunters="" would="" spend="" between="" $254="" and="" $592="" million="" at="" small="" businesses="" in="" 1996.="" the="" approval="" of="" tungsten-iron="" as="" an="" alternative="" shot="" to="" steel="" and="" bismuth-tin="" will="" have="" a="" minor="" positive="" impact="" on="" small="" businesses="" by="" allowing="" them="" to="" sell="" a="" third="" nontoxic="" shot="" to="" the="" hunting="" public.="" however,="" the="" overall="" effect="" to="" hunting="" expenditures="" in="" general="" would="" be="" minor.="" therefore,="" the="" service="" determined="" 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.="" the="" service="" anticipates="" 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.="" the="" service="" has="" examined="" this="" regulation="" under="" the="" paperwork="" reduction="" act="" of="" 1995="" and="" found="" it="" to="" contain="" no="" information="" collection="" requirements.="" however,="" the="" service="" does="" have="" omb="" approval="" (1018-0067;="" expires="" 06/30/="" 2000)="" for="" information="" collection="" relating="" to="" what="" manufacturers="" of="" shot="" are="" required="" to="" provide="" the="" service="" for="" the="" nontoxic="" shot="" approval="" process.="" for="" further="" information="" see="" 50="" cfr="" 20.134.="" 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="" service,="" in="" promulgating="" this="" rule,="" determines="" that="" these="" regulations="" meet="" the="" applicable="" standards="" provided="" in="" sections="" 3(a)="" and="" 3(b)(2)="" of="" executive="" order="" 12988.="" list="" of="" subjects="" in="" 50="" cfr="" part="" 20="" exports,="" hunting,="" imports,="" reporting="" and="" recordkeeping="" requirements,="" transportation,="" wildlife.="" accordingly,="" the="" service="" proposes="" 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.="" amend="" section="" 20.21="" by="" revising="" paragraph="" (j)(2)="" to="" read="" as="" follows:="" sec.="" 20.21="" hunting="" methods.="" *="" *="" *="" *="" *="" (j)="" *="" *="" *="" (2)="" tungsten-iron="" shot="" (nominally="" 40="" parts="" tungsten:="" 60="" parts="" iron="" with=""><1 percent="" residual="" lead)="" is="" legal="" as="" nontoxic="" shot="" for="" the="" 1998-="" 99="" migratory="" bird="" hunting="" season,="" except="" in="" the="" yukon-kuskokwim="" (y-k)="" delta,="" alaska.="" dated:="" july="" 14,="" 1998.="" donald="" j.="" barry,="" assistant="" secretary="" for="" fish="" and="" wildlife="" and="" parks.="" [fr="" doc.="" 98-19891="" filed="" 7-24-98;="" 8:45="" am]="" billing="" code="" 4310-55-p="">