[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]]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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