[Federal Register Volume 63, Number 235 (Tuesday, December 8, 1998)]
[Rules and Regulations]
[Pages 67619-67624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32470]
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DEPARTMENT OF INTERIOR
Fish and Wildlife Service
50 CFR Part 20
RIN 1018-AE38
Migratory Bird Hunting; Temporary Conditional Approval of
Tungsten-Matrix Shot as Nontoxic for the 1998-99 Season
AGENCY: Fish and Wildlife Service, Interior.
ACTION: Final rule.
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SUMMARY: The U.S. Fish and Wildlife Service (Service) amends Section
20.21(j) to grant temporary conditional approval of tungsten-matrix
shot as nontoxic for the 1998-99 migratory bird hunting season only,
except in the Yukon-Kuskokwim (Y-K) Delta, Alaska, while chronic
toxicity/reproductive testing is being completed. Tungsten-matrix shot
has been submitted for consideration as nontoxic by Kent
[[Page 67620]]
Cartridge Manufacturing Company, Ltd. (Kent), of Kearneysville, West
Virginia.
DATES: This rule takes effect immediately upon publication on December
8, 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., 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: 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. On October 7, 1998
tungsten-iron (63 FR 54015) and tungsten-polymer (63 FR 54021) shot
were given temporary conditional approval for the 1998-99 hunting
season. Compliance with the use of nontoxic shot has increased 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 Kent was initiated prior to implementation of the new
protocol. To date, scientific information presented in the application
suggests that tungsten-matrix is nontoxic under conditions for the
proposed shot configuration. Therefore, the Service will grant
temporary conditional approval for the 1998-99 hunting season only.
Final approval will not be granted until chronic toxicity/reproductive
testing is successfully completed and the results are reviewed and
approved by the Director.
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. Tungsten-
matrix pellets have 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'' (63 FR 30044; June 2,
1998). After consultation with the Service, Kent subsequently changed
the composition of their shot and removed several metal components. 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.
Kent's updated application includes a description of the
reformulated tungsten-matrix shot, a toxicological report (Thomas
1997), and results of a 30-day dosing study of the toxicity of the
original formulation 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) and information on
environmental fate and transport. The toxicity study is a 30-day dosing
test to determine if the original 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). Because the re-formulated shot
contains no new components, and in fact has had components removed, the
Service determined that testing of the reformulated shot in the form of
a new 30-day dosing study was not necessary.
Toxicity Information: There is considerable difference in the
toxicity of soluble and insoluble compounds of tungsten. Elemental
tungsten, which is the material used in this shot, is virtually
insoluble and is therefore expected to be relatively nontoxic. Even
though most toxicity tests reviewed were based on soluble tungsten
compounds rather than elemental tungsten (while the toxicity of the
polymers is negligible due to its insolubility), there appears to be no
basis for concern of toxicity to wildlife for tungsten-matrix shot
(metallic tungsten and polymers) via ingestion by fish, birds, or
mammals (Wildlife International Ltd., 1998; Bursian et al., 1996;
Gigiema, 1983; Patty, 1981; Industrial Medicine 1946; Karantassis
1924).
Environmental Fate and Transport: Tungsten is insoluble in water
and, therefore, not mobile in hypergenic environments. Tungsten is very
stable in acids and does not easily complex. Preferential uptake by
plants in acid soil suggests that uptake of tungsten in the anionic
form is associated with tungsten minerals rather than elemental
tungsten (Kabata-Pendias and Pendias 1984).
Environmental Concentrations: Calculation of the estimated
environmental concentration (EEC) of tungsten in a terrestrial
ecosystem is based on 69,000 shot per hectare (Pain 1990), assuming
complete erosion of material in 5 cm of soil. The EECs for tungsten and
the 2 polymers in soil are 25.7 mg/kg, 4.2 mg/kg, and 0.14 mg/kg,
respectively. Calculation of the EEC in an aquatic ecosystem assumes
complete erosion of the shot in one cubic foot of water. The EECs in
water for tungsten and the 2 polymers are 4.2 mg/L, 0.2 mg/L, and 0.02
mg/L, respectively. Tungsten-matrix shot is considered insoluble and is
stable in basic, neutral, and mildly acidic environments. Therefore,
erosion of shot is expected to be minimal, and adverse effects on biota
are not expected to occur.
Effects on Birds: An extensive literature review provided
information on the toxicity of elemental tungsten to waterfowl and
other birds. Ringelman et al. (1993), orally dosed 20 8-week-old game-
farm mallards with 12-17 (1.03g) 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
examination, 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 et al. (1981) fed laying hens (Gallus domesticus) 0.4 or 1 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 et al. 1981). The loss of tungsten
from the liver occurred in an exponential manner with a half-life of
[[Page 67621]]
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.
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. 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.
Kent's 30-day dosing study on the original formulation (Wildlife
International Ltd., 1998) 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.
Based on the results of the toxicological report and the toxicity
test of the original shot formulation (Tier 1 and 2), the Service
concludes that tungsten-matrix shot, (approximately 95.9 percent
tungsten and 4.1 percent polymer, 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="" has="" some="" concern="" that="" absorption="" of="" tungsten="" into="" the="" femur,="" kidney,="" and="" liver,="" as="" noted="" in="" a="" separate="" study="" on="" mallards,="" could="" potentially="" affect="" the="" spectacled="" eider="" (somateria="" fischeri);="" a="" species="" already="" subject="" to="" adverse="" weather,="" predation,="" and="" lead="" poisoning="" on="" the="" yukon-kuskokwim="" (y-k)="" delta,="" alaska.="" until="" chronic="" toxicity/reproductive="" testing="" has="" been="" successfully="" completed="" and="" the="" service="" has="" reviewed="" and="" approved="" the="" results,="" tungsten-matrix="" shot="" cannot="" be="" approved="" for="" the="" y-k="" delta.="" 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)(i)(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="" tungsten-matrix="" shot="" is="" nontoxic="" to="" waterfowl="" and="" their="" offspring.="" the="" second="" condition="" of="" final="" unconditional="" approval="" is="" testing="" for="" residual="" lead="" levels.="" any="" tungsten-matrix="" 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).="" kent="" documented="" that="" tungsten-matrix="" shot="" has="" 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.="" this="" requirement="" was="" incorporated="" into="" regulations="" at="" 50="" cfr="" 20.134(b)(6)="" in="" the="" december="" 1,="" 1997,="" final="" rule="" (62="" fr="" 63608).="" a="" noninvasive="" field="" testing="" device="" is="" under="" development="" to="" separate="" tungsten-matrix="" shot="" from="" lead="" shot.="" tungsten-="" matrix="" shot="" cannot="" be="" drawn="" to="" a="" magnet="" as="" a="" simple="" field="" detection="" method.="" the="" service="" incorrectly="" stated="" in="" the="" proposed="" rule="" of="" october="" 19,="" 1998,="" that="" tungsten-matrix="" was="" magnetic="" (63="" fr="" 55842).="" in="" summary,="" this="" rule="" amends="" 50="" cfr="" 20.21(j)="" by="" temporarily="" approving="" tungsten-matrix="" shot="" as="" nontoxic="" for="" the="" 1998-99="" migratory="" bird="" hunting="" season="" throughout="" the="" united="" states,="" except="" for="" the="" y-k="" delta="" in="" alaska.="" it="" is="" based="" on="" the="" request="" made="" to="" the="" service="" by="" kent="" cartridge="" on="" september="" 18,="" 1997="" (subsequently="" modified),="" the="" toxicological="" reports,="" and="" the="" acute="" toxicity="" studies.="" results="" of="" the="" toxicological="" report="" and="" 30-day="" toxicity="" test="" undertaken="" for="" kent="" cartridge="" indicate="" the="" apparent="" absence="" of="" any="" deleterious="" effects="" of="" tungsten-matrix="" shot="" when="" ingested="" by="" captive-reared="" mallards="" or="" to="" the="" ecosystem.="" final="" unconditional="" approval="" of="" tungsten-matrix="" shot="" as="" nontoxic="" for="" the="" entire="" u.s.="" will="" not="" be="" considered="" until="" all="" required="" chronic="" toxicity/reproductive="" tests="" have="" been="" successfully="" completed="" and="" the="" results="" are="" reviewed="" and="" approved="" by="" the="" director.="" public="" comments="" and="" responses="" the="" october="" 19,="" 1998,="" proposed="" rule="" published="" in="" the="" federal="" register="" (63="" fr="" 55840)="" invited="" public="" comments="" from="" interested="" parties.="" the="" closing="" date="" for="" receipt="" of="" all="" comments="" was="" november="" 18,="" 1998.="" during="" this="" 30-day="" comment="" period,="" the="" service="" received="" eight="" comments.="" the="" california="" waterfowl="" association="" strongly="" supported="" the="" proposed="" temporary="" approval="" of="" tungsten-matrix="" shot="" for="" the="" 1998-99="" season.="" they="" believed="" that="" temporary="" approval="" of="" tungsten-matrix="" shot="" was="" an="" important="" step="" to="" address="" concerns="" relating="" to="" efforts="" to="" reduce="" unnecessary="" crippling="" of="" waterfowl="" through="" development="" of="" more="" effective="" nontoxic="" shot="" materials.="" the="" wildlife="" legislative="" fund="" of="" america="" encouraged="" the="" service="" to="" approve="" tungsten-matrix="" shot="" for="" the="" 1998-99="" season.="" they="" believe="" that="" approval="" of="" tungsten-matrix="" would="" help="" fulfill="" the="" objective="" of="" making="" lead="" shot="" substitutes="" available="" to="" hunters.="" the="" international="" association="" of="" fish="" and="" wildlife="" agencies="" supported="" temporary="" and="" conditional="" approval="" of="" tungsten-matrix="" shot="" for="" the="" 1998-99="" season.="" they="" acknowledged="" that="" final="" approval="" is="" pending="" successful="" completion="" of="" further="" testing.="" the="" wisconsin="" department="" of="" natural="" resources="" (wisconsin)="" supported="" temporary="" approval="" of="" tungsten-matrix="" [[page="" 67622]]="" provided="" there="" is="" no="" scientific="" evidence="" that="" indicates="" it="" is="" toxic="" to="" waterfowl="" or="" the="" environment.="" however,="" wisconsin="" expressed="" concern="" about="" the="" timing="" of="" the="" proposed="" and="" final="" rules="" and="" the="" confusion="" that="" it="" creates="" for="" hunters.="" they="" encouraged="" the="" service="" to="" initiate="" publication="" of="" rules="" concerning="" nontoxic="" shot="" before="" august="" 1="" to="" allow="" proper="" planning="" by="" states.="" the="" national="" rifle="" association="" urged="" the="" service="" to="" temporarily="" approve="" tungsten-matrix="" shot="" for="" the="" remainder="" of="" the="" 1998-99="" season.="" they="" further="" expressed="" their="" support="" of="" research="" and="" development="" of="" ballistically="" efficient="" nontoxic="" shot="" ammunition.="" the="" wildfowl.net="" organization="" expressed="" concern="" that="" the="" service="" has="" not="" taken="" steps="" to="" approve="" tungsten-matrix="" shot="" in="" a="" prompt="" manner.="" they="" questioned="" why="" the="" service="" could="" not="" approve="" a="" generic="" tungsten="" shotload,="" in="" a="" manner="" similar="" to="" steel="" shot.="" finally,="" they="" inquired="" whether="" the="" service="" intends="" to="" either="" arrest="" and/or="" cite="" waterfowl="" hunters="" that="" use="" tungsten-matrix="" shot="" prior="" to="" granting="" final="" approval="" of="" the="" shot.="" kent="" cartridge="" company="" (kent)="" supported="" prompt="" conditional="" approval="" of="" tungsten-matrix="" shot="" for="" the="" 1998-99="" waterfowl="" hunting="" season.="" they="" stated="" that="" they="" fully="" intend="" to="" complete="" chronic="" toxicity/reproductive="" testing="" on="" tungsten-matrix="" shot="" that="" is="" required="" before="" final="" approval="" can="" be="" considered.="" kent="" pointed="" out="" that="" the="" concentration="" of="" lead="" in="" their="" shot="" is="" below="" the="" 1="" percent="" level="" that="" the="" service="" has="" stipulated="" for="" nontoxic="" shot.="" furthermore,="" they="" indicated="" that="" noninvasive="" field="" testing="" equipment="" for="" detecting="" tungsten-matrix="" shot="" is="" expected="" to="" be="" available="" shortly.="" the="" federal="" cartridge="" company="" (federal)="" noted="" that="" a="" complete="" description="" of="" candidate="" shot="" materials="" must="" be="" submitted="" to="" the="" director,="" and="" that="" a="" complete="" description="" of="" tungsten-matrix="" shot="" was="" not="" published="" in="" the="" federal="" register.="" federal="" also="" questioned="" whether="" the="" 2="" percent="" iron,="" referenced="" in="" the="" initial="" application,="" was="" removed="" from="" the="" candidate="" shot="" as="" it="" was="" not="" mentioned="" in="" the="" october="" 19="" proposed="" rule="" description.="" lastly,="" federal="" questioned="" whether="" tungsten-="" matrix="" shot="" could="" be="" drawn="" to="" a="" magnet="" as="" a="" field="" test="" method.="" service="" response:="" regarding="" the="" timing="" of="" the="" rulemaking,="" the="" service="" recognizes="" the="" information="" dissemination="" problems="" caused="" by="" conditionally="" approving="" tungsten-matrix="" shot="" at="" this="" time.="" however,="" the="" service="" acts="" on="" nontoxic="" shot="" applications="" as="" they="" are="" received.="" therefore,="" when="" applications="" are="" approved,="" either="" conditionally="" or="" permanently,="" the="" service="" proceeds="" with="" the="" application="" process="" regardless="" of="" the="" timing="" of="" hunting="" seasons.="" because="" kent's="" application="" was="" being="" treated="" under="" the="" old="" nontoxic="" shot="" approval="" process,="" which="" provided="" for="" conditional="" approval,="" the="" service="" decided="" to="" proceed="" with="" this="" rulemaking.="" providing="" another="" nontoxic="" shot="" option="" for="" hunting="" waterfowl="" and="" coots="" likely="" will="" improve="" hunter="" compliance,="" thereby="" reducing="" the="" amount="" of="" lead="" shot="" in="" the="" environment.="" regarding="" the="" assertion="" that="" the="" service="" has="" not="" processed="" temporary="" approval="" of="" tungsten-matrix="" shot="" in="" a="" prompt="" manner,="" we="" stress="" that="" the="" service="" made="" every="" attempt="" to="" process="" kent's="" application="" as="" quickly="" as="" possible.="" regarding="" the="" question="" of="" whether="" approval="" can="" be="" given="" for="" generic="" tungsten="" shots,="" we="" point="" out="" that="" for="" the="" three="" tungsten="" shot="" applications="" currently="" being="" processed="" by="" the="" service="" (tungsten-iron,="" tungsten-polymer,="" and="" tungsten-matrix),="" no="" data="" has="" been="" submitted="" on="" the="" required="" chronic="" toxicity/reproductive="" tests.="" without="" such="" information,="" it="" would="" not="" be="" prudent="" to="" approve="" a="" generic="" tungsten="" shot="" type.="" the="" revised="" test="" protocol="" for="" nontoxic="" approval="" procedures="" (50="" cfr="" 20.134)="" published="" in="" the="" federal="" register="" on="" december="" 1,="" 1997="" (62="" fr="" 63608)="" established="" a="" three-tier="" approval="" process.="" the="" system="" has="" three="" tiers,="" with="" each="" tier="" enhancing="" the="" information="" base="" on="" the="" candidate="" material.="" those="" candidate="" materials="" where="" appropriate="" background="" information,="" toxicological="" data,="" ecological="" risk="" assessment,="" and="" reproductive="" effects="" information="" are="" available="" demonstrating="" the="" candidate="" material="" to="" be="" benign="" may="" receive="" nontoxic="" approval.="" applications="" for="" nontoxic="" approval="" of="" candidate="" shots="" submitted="" after="" december,="" 1997,="" must="" satisfy="" all="" information="" requirements="" determined="" by="" the="" service="" before="" any="" form="" of="" approval="" can="" be="" granted.="" without="" chronic="" toxicity/reproductive="" test="" data="" (tier="" 3)="" there="" would="" be="" insufficient="" information="" to="" approve="" future="" tungsten="" shot="" applications="" under="" the="" new="" test="" protocol.="" furthermore,="" depending="" on="" the="" specific="" composition="" of="" future="" tungsten="" candidate="" shot="" types="" and="" associated="" concerns="" over="" their="" toxicity,="" there="" may="" be="" sufficient="" cause="" for="" requiring="" additional="" information="" before="" approval="" can="" be="" granted.="" regarding="" whether="" the="" service="" intends="" to="" arrest="" or="" cite="" waterfowl="" hunters="" that="" use="" tungsten-matrix="" shot="" prior="" to="" granting="" final="" permanent="" approval="" of="" the="" shot,="" we="" would="" like="" to="" clarify="" that="" the="" service="" is="" not="" requiring="" final="" permanent="" approval="" of="" tungsten-matrix="" shot="" before="" making="" it="" legal="" for="" the="" 1998-99="" season.="" final="" permanent="" approval="" of="" tungsten-matrix="" will="" not="" be="" considered="" until="" results="" from="" chronic="" toxicity/reproductive="" testing,="" scheduled="" to="" be="" conducted="" during="" spring="" 1999,="" are="" submitted="" to="" the="" service="" for="" review.="" we="" emphasize="" that="" this="" rule="" grants="" temporary="" approval="" of="" the="" shot="" for="" hunting="" waterfowl="" and="" coots="" for="" the="" remainder="" of="" the="" 1998-99="" hunting="" season="" only.="" therefore,="" as="" of="" the="" publication="" date="" of="" this="" rule="" and="" for="" the="" remainder="" of="" the="" 1998-99="" season="" only,="" hunters="" using="" tungsten-matrix="" to="" hunt="" waterfowl="" and="" coots="" during="" the="" current="" season="" would="" be="" in="" compliance="" with="" the="" law="" and="" should="" not="" be="" cited.="" the="" service="" is="" pleased="" that="" kent="" intends="" to="" complete="" the="" required="" chronic="" toxicity/reproductive="" testing="" of="" their="" tungsten-matrix="" shot.="" we="" look="" forward="" to="" reviewing="" the="" results="" of="" such="" tests="" as="" soon="" as="" possible="" so="" that="" a="" decision="" can="" be="" made="" on="" the="" shot's="" nontoxic="" status="" before="" the="" 1999-2000="" hunting="" season.="" regarding="" the="" questions="" on="" shot="" composition,="" the="" composition="" of="" tungsten-matrix="" shot="" approved="" by="" this="" rule="" is="" not="" magnetic="" and="" no="" longer="" contains="" 2="" percent="" iron.="" both="" of="" these="" issues="" were="" oversights="" on="" our="" part="" in="" the="" october="" 19="" proposed="" rule.="" regarding="" the="" completeness="" of="" the="" description="" of="" the="" subject="" shot="" material,="" kent="" included="" a="" complete="" description="" of="" tungsten-matrix="" shot="" in="" their="" application="" to="" the="" service,="" including="" the="" specific="" polymers="" used="" in="" the="" shot.="" sufficient="" information="" was="" contained="" in="" kent's="" application="" to="" allow="" the="" service="" to="" assess="" short-term="" toxicity="" of="" the="" shot="" and="" subsequently="" grant="" temporary="" approval="" for="" the="" remainder="" of="" the="" 1998-99="" hunting="" season.="" because="" kent="" requested="" that="" the="" service="" not="" divulge="" proprietary="" information="" concerning="" the="" nature="" of="" the="" polymers="" used="" in="" their="" shot,="" the="" exact="" description="" of="" the="" polymers="" will="" not="" be="" published.="" effective="" date="" under="" the="" apa="" (5="" u.s.c.="" 553="" (d))="" the="" service="" waives="" the="" 30-day="" period="" before="" the="" rule="" becomes="" effective="" and="" finds="" 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.="" during="" the="" public="" comment="" period="" for="" temporary="" conditional="" approval="" the="" service="" received="" eight="" comments.="" of="" these="" comment="" letters,="" six="" were="" from="" conservation="" organizations,="" one="" was="" from="" a="" state="" natural="" resource="" agency,="" [[page="" 67623]]="" and="" one="" was="" from="" an="" ammunition="" manufacturer.="" all="" objections/comments="" have="" been="" remedied="" satisfactorily="" and="" are="" discussed="" under="" the="" public="" comment="" and="" responses="" section="" of="" this="" document.="" it="" is="" in="" the="" best="" interest="" of="" migratory="" birds="" and="" their="" habitats="" to="" grant="" temporary="" conditional="" approval="" to="" tungsten-matrix="" shot="" as="" nontoxic="" for="" the="" 1998-="" 99="" migratory="" bird="" hunting="" season.="" it="" is="" in="" the="" best="" interest="" of="" the="" hunting="" public="" to="" provide="" them="" an="" additional="" legal="" option="" for="" hunting="" waterfowl="" and="" coots="" for="" the="" 1998-99="" season,="" which="" began="" on="" september="" 1,="" 1998.="" it="" is="" in="" the="" best="" interest="" of="" small="" retailers="" who="" have="" stocked="" tungsten-matrix="" shot="" for="" the="" current="" season.="" the="" service="" believes="" another="" nontoxic="" shot="" option="" likely="" will="" improve="" hunter="" compliance,="" thereby="" reducing="" the="" amount="" of="" lead="" shot="" in="" the="" environment.="" references="" 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-polymer="" shot="" in="" game-farm="" mallards.="" report="" to="" federal="" cartridge="" co.="" 77="" pp.="" gigiema="" i="" sanitariya.="" 1983.="" mezhdunarodnaya="" kniga.="" moscow,="" ussr.="" 48(7):77.="" industrial="" medicine.="" 1946.="" volume="" 15,="" p.="" 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.="" 28:1541091543.="" 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):1098.="" 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;="" bryden,="" w.="" l.;="" heard,="" g.="" s.;="" balnave,="" d.="" 1981.="" reproductive="" performance="" of="" laying="" hens="" fed="" tungsten.="" poultry="" science="" 60(1):257-258.="" 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.="" peterson,="" j.="" e.="" 1977.="" industrial="" health.="" prentice-hall,="" englewood="" cliffs,="" nj.="" ringelman,="" j.="" k.,="" m.="" w.="" miller="" and="" w.="" f.="" andelt.="" 1993.="" effects="" of="" ingested="" tungsten-bismuth-tin="" shot="" on="" mallards.="" co="" div.="" wildl.,="" fort="" collins,="" 24="" pp.="" thomas,="" v.="" g.="" 1997.="" application="" for="" approval="" of="" tungsten-matrix="" shot="" as="" non-toxic="" for="" the="" hunting="" of="" migratory="" birds.="" 39="" pp.="" wildlife="" international,="" ltd.="" 1998.="" tungsten-matrix="" shot:="" an="" oral="" toxicity="" study="" with="" the="" mallard.="" project="" no.="" 475-101.="" 162="" 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="" in="" october="" 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-matrix="" 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-matrix="" 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="" 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="" 1998="" (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="" 1996="" national="" hunting="" and="" fishing="" survey="" which="" it="" was="" estimated="" that="" migratory="" bird="" hunters="" would="" spend="" between="" $429="" and="" $1084="" million="" nationwide="" at="" small="" businesses="" in="" 1998.="" the="" approval="" of="" tungsten-matrix="" as="" an="" alternative="" shot="" to="" steel="" will="" have="" a="" minor="" positive="" impact="" on="" small="" businesses="" by="" allowing="" them="" to="" sell="" another="" 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.="" executive="" order="" 12866="" this="" rule="" was="" 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.="" the="" service="" invites="" 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="" the="" service="" do="" to="" make="" the="" rule="" easier="" to="" understand?="" send="" a="" copy="" of="" any="" comments="" that="" concern="" how="" this="" rule="" could="" be="" made="" easier="" to="" understand="" to:="" office="" of="" regulatory="" affairs,="" department="" of="" the="" interior,="" room="" 7229,="" 1849="" c="" street,="" n.w.,="" washington,="" d.c.="" 20240.="" comments="" may="" also="" be="" e-mailed="" to:="">xsec@ios.doi.gov.
[[Page 67624]]
Congressional Review
In accordance with Section 251 of the Small Business Regulatory
Enforcement Fairness Act of 1996 (5 U.S.C. 8), this rule has been
submitted to Congress. Because this rule deals with the Service's
migratory bird hunting program, this rule qualifies for an exemption
under 5 U.S.C. 808(1); therefore, the Department determines that this
rule shall take effect immediately.
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. 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.
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 record-keeping
requirements, Transportation, Wildlife. Accordingly, Part 20,
subchapter B, chapter 1 of Title 50 of the Code of Federal Regulations
is 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)(4) 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="" 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="" such="" shot="" approved="" as="" nontoxic="" by="" the="" director="" pursuant="" to="" procedures="" set="" forth="" in="" 20.134,="" provided="" that:="" (1)="" *="" *="" *="" (4)="" 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="" 1998-1999="" hunting="" season="" only,="" except="" for="" the="" yukon-kuskokwim="" delta="" habitat="" in="" alaska.="" dated:="" december="" 1,="" 1998.="" donald="" j.="" barry,="" assistant="" secretary="" for="" fish="" and="" wildlife="" and="" parks.="" [fr="" doc.="" 98-32470="" filed="" 12-7-98;="" 8:45="" am]="" billing="" code="" 4310-55-p="">