[Federal Register Volume 62, Number 156 (Wednesday, August 13, 1997)]
[Rules and Regulations]
[Pages 43444-43447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21448]


      

[[Page 43443]]

_______________________________________________________________________

Part III





Department of the Interior





_______________________________________________________________________



Fish and Wildlife Service



_______________________________________________________________________



50 CFR Part 20



Migratory Bird Hunting; Temporary Conditional Approval of Tungsten-Iron 
Shot as Nontoxic for the 1996-98 Season; Final Rule

Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / 
Rules and Regulations

[[Page 43444]]


=======================================================================
-----------------------------------------------------------------------


DEPARTMENT OF INTERIOR

Fish and Wildlife Service

50 CFR Part 20

RIN 1018-AE09


Migratory Bird Hunting; Temporary Conditional Approval of 
Tungsten-Iron Shot as Nontoxic for the 1997-98 Season

AGENCY: Fish and Wildlife Service, Interior.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The U.S. Fish and Wildlife Service (Service) amends Section 
20.21(j) and temporarily approves tungsten-iron shot as nontoxic for 
the 1997-98 migratory bird hunting season. The toxicological report and 
extensive literature search and analysis suggests that tungsten and 
tungsten-iron are nontoxic under conditions for the proposed shot 
configuration. Analysis of the toxicity study reveals no adverse 
effects over a 30-day period when dosing mallards with 8 BB-size 
tungsten-iron shot.

EFFECTIVE DATE: September 1, 1997.

FOR FURTHER INFORMATION CONTACT: Paul R. Schmidt, Chief, or Carol 
Anderson, 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, when spent, does not pose a significant toxic 
hazard to migratory birds and other wildlife. Currently, steel shot and 
bismuth-tin shot are approved by the Service as nontoxic. 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. The Service is eager to consider 
these other materials for approval as nontoxic shot.
    Federal Cartridge Company's (Anoka, MN) candidate shot is made from 
sintering tungsten and iron, which forms a two-phase alloy. Shot made 
from this material has a density of approximately 10.3 gm/cc, or 94 
percent of the density of lead. The tested shot will contain nominally 
55 percent tungsten and 45 percent iron, by weight; whereas, the 
marketed shot will contain nominally 40 percent tungsten and 60 percent 
iron, by weight. The pellet will have sufficient iron to attract a 
magnet. The Service, in consultation with the U.S. Geological Service, 
Biological Resources Division, considers the higher tungsten ratio of 
the tested shot more potentially toxic and that the lower ratio of the 
marketed shot poses significantly less risk.
    Federal's application includes a description of the new tungsten-
iron shot, a toxicological report, and results of a 30-day dosing study 
(Test 1) to assess the toxicity of this shot in game-farm mallards as 
outlined in 50 CFR 20.134(c)(2). 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.
    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 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).
    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: The expected environmental 
concentration (EEC) is defined as the concentration of a chemical in a 
particular environmental compartment that is based on an estimate or 
modeling simulation of use, disposal, transport, and fate of a 
chemical. Calculation of the 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 of 
shot material left in the soil after the initial degradation of the 
shot. This calculated amount is based on shot composed 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).
    Calculation of the expected 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 left in the 
water after the initial degredation of the shot. This calculated amount 
is based on shot composed 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. 
Ringelman et al.'s (1993) investigation of the effects of ingested 
tungsten-bismuth-tin (TBT) shot on captive mallards found no acute 
toxicity. Orally dosing 28-week old game-farm mallards with 12 to 17 
pellets (1.03g) of TBT shot revealed no evidence of intoxication over a 
period of 32 days. 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 authors 
concluded that TBT shot presents virtually no potential for acute 
intoxication in mallards.
    A study by Kraabel et al. (1996) assessed 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 1g/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 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<greek-m>g/g liver. At this concentration, the

[[Page 43445]]

activity of xanthine dehydrogenase was zero.
    In Federal's dosing study, eight male and 8 female adult mallards 
were given 8 #4 steel shot, 8 #4 lead shot, or 8 BB's of tungsten-iron 
and 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. There was 
some absorption of tungsten in the femur, kidney, and liver, with some 
effect on the bile. In general,however, 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 
was 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. Hematocrit, hemoglobin concentrations, and ALAD activity were 
significantly depressed at day 15 in the lead-dose females, while lead-
dose 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 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. The Service has some concern that the 
absorption of tungsten into the femur, kidney, and liver may have some 
potential effect on the spectacled eider (Somateria fischeri), a 
species already subject to adverse weather, predation, and lead 
poisoning when waterfowl are harvested in its Yukon-Kuskokwim Delta (Y-
K Delta) habitat in Alaska. Until the results of reproductive/chronic 
toxicity tests, which includes the assessment of reproduction, 
fertility rates, and egg hatchability (egg weight, shell thickness, and 
content analysis) have been completed and the Service has reviewed the 
results, tungsten-iron shot cannot be conditionally approved for the Y-
K Delta habitat in Alaska.
    The first condition of final unconditional approval is the 
concurrent running of an adverse condition test (Test 2) and a 
reproductive/chronic toxicity test (Test 3) on game-farm mallards as 
outlined in 50 CFR 20.134 (c)(2) 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 
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 second condition of final unconditional approval is testing for 
residual lead levels. In the Federal Register of August 18, 1995 (60 FR 
43314), the Service indicated it would establish a maximum level for 
residual lead. The Service, in consultation with the USGS--Division of 
Biological Resources, determined the maximum environmentally acceptable 
level of lead in any nontoxic shot is trace amounts or <1 percent and 
is incorporating this requirement into this rule and will incorporate 
it into any subsequent final rule that may be promulgated. Federal 
documented that the tungsten-iron 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 tungsten-iron shot from lead 
shot. Furthermore, tungsten-iron shot can be drawn to a magnet as a 
simple field detection method.
    This rule amends 50 CFR 20.21(j) by temporarily approving tungsten-
iron shot as nontoxic for the 1997-98 migratory bird hunting season 
throughout the United States except for the Y-K Delta habitat in 
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. Results of the toxicological report and 30-
day toxicity test undertaken for Federal Cartridge Company indicate the 
apparent absence of any deleterious effects of tungsten-iron shot when 
ingested by captive-reared mallards or to the ecosystem.

Public Comments and Responses

    The January 31, 1997, proposed rule published in the Federal 
Register (62 FR 4877) invited public comments from interested parties. 
The closing date for receipt of all comments was April 1, 1997. During 
this 60-day comment period, the Service received five comment letters. 
Of these comment letters, three were from individuals and two from 
industry organizations. Individuals expressed support for the temporary 
approval of tungsten-iron shot. Individuals ``. . . would love the 
opportunity to try the new shot'' and believed that ``. . . any 
nontoxic alternative that approaches the effectiveness of lead should 
be explored.''
    The Bismuth Cartridge Company (Bismuth) is concerned that the 
Service should ensure that all applicants for non-toxic shot approval 
are subject to comparable requirements and conditions. The Service does 
ensure that any candidate nontoxic material will comply with current 
regulations set forth in 50 CFR 20.134 for nontoxic shot approval. 
Applications for approval must include a description of the candidate 
shot, a toxicological report on the candidate shot, and a 30-day dosing 
test with mallards. As new information becomes available, applications 
may be revised to include this information, which will assist the 
Service in evaluating the candidate material.
    Furthermore, Bismuth stated that ``...no testing of reproductive 
tissues (i.e., gonads) was conducted in association with Federal's 30-
day toxicity testing.'' The current regulations do not require that 
gonads be chemically analyzed for metals in Test 1. The Service 
notified Federal that this would not be a requirement during the Test 1 
phase because Federal demonstrated that there was existing data on the 
effects of tungsten and iron on the reproductive tissues in the 
scientific literature. Once the shot is conditionally approved, 
guidance for further testing is provided to the applicant. Following 
satisfactory completion of Tests 1, 2, and 3, or their equivalent, and 
publication of a summary of these results in the Federal Register for 
public comment, the candidate material is concomitantly proposed for 
inclusion in 50 CFR 20.21(j).
    Bismuth is also concerned that Federal is not being held to as 
strict a requirement as they were during their application process for 
approval of bismuth-tin. Bismuth states that they

[[Page 43446]]

conducted additional assays to demonstrate that bismuth-tin shot's 
residual lead levels were at levels well below the <1 percent standard. 
Their concern lies in the fact that the proposed rule does not state 
that the applicant will need to provide data demonstrating the absence 
of any carcinogenic materials in its shot. The Service required the 
applicant to demonstrate that the candidate shot contains no 
significant trace levels of lead or other toxic or carcinogenic 
materials. The Service indicated in the August 18, 1995, Federal 
Register, that a maximum level of residual lead would be established. 
The Service, in consultation with the USGS--Division of Biological 
Resources (formerly the National Biological Service), determined the 
maximum environmentally acceptable level of lead in bismuth-tin shot is 
trace amounts or <1 percent. This requirement was incorporated in the 
final rule approving bismuth-tin shot. This same requirement applies to 
tungsten-iron shot.
    Winchester states ``the shot sample submitted for the acute 
toxicity portion of the required testing was significantly different 
from the shot that is being marketed and requested for approval.'' 
Winchester analyzed samples of shot they obtained at retail and found 
that the tungsten-iron alloy phases varied. ``Since the application 
indicates that the shot is heated to thermal equilibrium and not 
chemical equilibrium, this is not surprising.'' Furthermore, two 
different phases of intermetallic compound (Fe<INF>2</INF>W and FeW) 
and pure tungsten were also present in the marketed shot. The Service 
requested additional information from Federal regarding the details of 
the manufacturing process of the tungsten-iron shot. Federal states the 
tungsten-iron shot is sintered at 1520 deg.C under a tight time and 
temperature tolerance. The Fe<INF>7</INF>W<INF>6</INF> compound is 
formed at thermal equilibrium, which takes into account all energy 
factors, unlike chemical equilibrium. The shot is then quickly cooled 
to ambient temperatures much like quenching steel. High cooling rates 
of the tungsten-iron shot, in part due to the small size of the 
tungsten-iron shot, preclude the formation of compounds other than 
Fe<INF>7</INF>W<INF>6</INF>. The Fe<INF>7</INF>W<INF>6</INF> that forms 
at the 1520 deg.C sintering temperature is cooled too quickly to change 
to other compounds. Transformation to other compounds is sluggish; x-
ray diffraction analysis confirms the absence of the other 
intermetallic compounds. The Toxicity Test 1, and subsequent Toxicity 
Tests 2 and 3, will be conducted using tungsten-iron shot representing 
a ``worst-case'' scenario, i.e., the shot being tested has a higher 
concentration of the Fe<INF>7</INF>W<INF>6</INF> compound than the shot 
Federal plans to manufacture for public use.
    Winchester also raised their concern about the fact that the 
``soft'' matrix of this tungsten-iron shot is as hard or harder than 
current gun barrels which have been designed for steel shot. The 
Service agrees that this should be a concern for the consumer. Federal 
recognized that the hardness of the tungsten-iron shot would require a 
new wad to protect shotgun bores from scouring. Federal designed a wad 
made of high-density polyethylene which features three inner petals 
overlapped by three outer petals so there are no exposed wad slits to 
allow the shot to contact the barrel or chokes. The wad's outer petals 
are designed to shear back or off once it exits the barrel. 
Additionally, tungsten-iron shot is not recommended for use with older 
shotguns or for fine double guns not designed to handle steel. Federal 
advises that these tungsten loads should only be shot through barrels 
and chokes approved for use with steel shot.
    Furthermore, Winchester is concerned that the payloads and/or 
pellet counts in the marketed shot have generally not been found to be 
effective, efficient harvesters of game at anything but very modest 
ranges. The primary shortcoming is insufficient pattern density to 
ensure the necessary number of pellet strikes for consistent, clean 
bagging of game. It is reasonable to expect the possibility of a high 
crippling rate for either of these very low pellet count loads. 
Previous uses of low pellet count, relatively high energy pellets have 
generally not yielded satisfactory results. Federal recognized that 
tungsten-iron shot has different ballistic properties than that of 
steel and bismuth-tin shot. Consequently, they conducted ballistic 
tests using ballistic software modeling and test-firing the tungsten 
shot. Their research indicated that a relatively light payload with a 
high velocity was the best alternative. Tests show that the new loads 
shot tight patterns like steel; offered ballistic advantages of high 
velocity; had better downrange energy than steel, bismuth, or lead; and 
produced better penetration than the other pellet materials. The 
Service expects that crippling rates may increase slightly with the 
advent of any new nontoxic shot; however, continued education and 
training of waterfowl hunters will help keep crippling loss to a 
minimum. The effectiveness of any shot is a function of the shooter's 
ability to place the pellets on the bird, the pellet's energy at point-
of-contact, and the pellet's ability to penetrate. Hunters should test 
different loads with their guns before hunting with any new shot so 
that adjustments can be made to their technique in order to reduce 
crippling losses. Initial field testing in Canada has shown that the 
tungsten-iron shot performed exceptionally well.

References

    A list of references is available and will be provided upon 
request.

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 December, 1996. This EA is available to the public 
at the Office of Migratory Bird Management, U.S. Fish and Wildlife 
Service, ms 634--ARLSQ, 1849 C Street NW., Washington D.C. 20240. Based 
on review and evaluation of the information in the EA, the Service 
determined the action to amend 50 CFR 20.21(j) to extend temporary 
conditional approval of tungsten-iron shot as nontoxic for 1997-98 and 
1998-99 migratory bird hunting seasons 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, ``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 ...'' Pursuant to section 7 of the ESA, MBMO 
sought review and concurrence that this action <gr-thn-eq>is not likely 
to adversely affect<gr-thn-eq> threatened, endangered, proposed, and 
category 1 species. Based on review and evaluation of the toxicity 
testing and available information, the Service determined that no 
adverse impact on endangered and threatened species would result from 
the proposed action. The results of this review may be inspected by the 
public in, and will be available to the public from, the Office of 
Migratory Bird Management, U.S. Fish and Wildlife Service, ms 634--

[[Page 43447]]

 ARLSQ, 1849 C Street NW, Washington D.C. 20240.

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), was issued by the Service in 1995. 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 estimated that migratory bird hunters would spend between $10 and 
$59 million at small businesses in 1995. 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.

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.

Authorship

    The primary author of this final rule is Carol Anderson, Office of 
Migratory Bird Management.

List of Subjects in 50 CFR Part 20

    Exports, Hunting, Imports, Reporting and recordkeeping 
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)(2) 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 such shot approved as nontoxic by the Director 
pursuant to procedures set forth in 20.134, provided that:
    (1) * * *
    (2) Tungsten-iron shot (nominally 40 parts tungsten: 60 parts iron 
with <1 percent residual lead) is legal as nontoxic shot for the 1997-
98 migratory bird hunting season, except for the Yukon-Kuskokwim Delta 
habitat in Alaska.

    Dated: August 7, 1997.
Donald J. Barry,
Acting Assistant Secretary for Fish and Wildlife and Parks.
[FR Doc. 97-21448 Filed 8-12-97; 8:45 am]
BILLING CODE 4310-55-F