[Federal Register Volume 63, Number 143 (Monday, July 27, 1998)]
[Proposed Rules]
[Pages 40074-40077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19890]


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DEPARTMENT OF INTERIOR

Fish and Wildlife Service

50 CFR Part 20

RIN 1018-AE66


Migratory Bird Hunting; Temporary Approval of Tungsten-Polymer 
Shot as Nontoxic for the 1998-99 Season

AGENCY: Fish and Wildlife Service, Interior.

ACTION: Proposed rule.

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SUMMARY: The U.S. Fish and Wildlife Service (Service) proposes to amend 
Section 20.21(j) and provide temporary approval of tungsten-polymer 
shot as nontoxic for the 1998-99 migratory bird hunting season, except 
in the Yukon-Kuskokwim (Y-K) Delta, Alaska. A toxicological report 
includes an extensive literature review, and analysis of tungsten and 
Nylon 6 (the polymer) suggests that these compounds are nontoxic under 
assumed use and in the environment. The toxicity study reveals no 
adverse effects over a 30-day period on mallards (Anas platyrhynchus) 
dosed with 8 BB-size tungsten-polymer 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 Yukon-Kuskokwim (Y-K) Delta, Alaska. Until a 
reproductive/chronic toxicity test has been completed and the Service 
has reviewed the results, the Service proposes not to approve the use 
of tungsten-polymer shot on the Y-K Delta.

DATES: Comments on the proposed rule must be received no later than 
August 26, 1998.

ADDRESSES: Comments may be sent 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: 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 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. The Service 
previously granted temporary approval

[[Page 40075]]

for bismuth-tin 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. The Service believes 
that approval of other suitable candidate shot materials as nontoxic is 
feasible. Compliance with the use of nontoxic shot has increased over 
the last few years. The Service believes that compliance will continue 
to increase with the approval and availability of other nontoxic shot 
types.
    Federal Cartridge Company's (Anoka, Minnesota) candidate shot is a 
matrix of Nylon 6 or 11 polymer surrounding particles of elemental 
tungsten. Shot made from this material has a density of approximately 
11.2 g/cm3 or approximately the density of lead. The shot 
will contain approximately 95.5 percent tungsten and 4.5 percent Nylon 
6 or 11 by weight, plus sufficient iron to attract a magnet.
    Federal's application includes a description of the new tungsten-
polymer (TP) shot, a toxicological report (Barr, 1996), and the results 
of a 30-day dosing study of 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 
mammals and birds, potential for environmental concern, and 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 will meet the 
requirements for Tier 2 consideration, as described in 50 CFR 
20.134(b)(3).

Toxicity Information

    There is considerable difference in the toxicity of soluble and 
insoluble compounds of tungsten. Elemental tungsten is virtually 
insoluble and is, therefore, expected to be relatively nontoxic. The 
potential toxicity of nylon compounds due to degradation is primarily 
associated with the stabilizers, antioxidants, plasticizers, and 
unreacted prepolymers. Residual caprolactum has been found in some 
commercial Nylon 6 products, but little concern regarding this compound 
has been developed (Patty, 1981). Even though most toxicity tests 
reviewed were based on soluble tungsten compounds rather than elemental 
tungsten (while the toxicity of Nylon 6 is negligible due to its 
insolubility), there appears to be no basis for concern of toxicity to 
wildlife for the TP shot (metallic tungsten and Nylon 6) 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 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 Nylon 6 in soil are 58.3 mg/kg and 2.7 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 Nylon 6 are 18.7 mg/L and 0.9 mg/L, 
respectively. The Hazard Quotients assume that complete erosion of the 
shot components would occur; however, the TP 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

    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 (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, 1981). The loss of tungsten from the 
liver occurred in an exponential manner with a half-life of 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.
    Nylon 6 is the commercially important homopolymer of caprolactum. 
Most completely polymerized nylon materials are physiologically inert, 
regardless of the toxicity of the monomer from which they are made 
(Peterson, 1977). Few data exist on the toxicity of Nylon 6 in animals. 
Most toxicity studies relate to thermal degradation products and so are 
not relevant to the exposure of wildlife to shot containing nylon. 
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.
    Federal's 30-day dosing study (Bursian et al., 1996) included four 
treatment groups of game-farm mallards (16 birds in each group, 8 males 
and 8 females) exposed to different types of shot: 8 No. 4 steel, 8 No. 
4 lead, 8 BBs of tungsten-polymer, and none (control). All TP-dosed 
birds survived the test with no significant alteration in body weight. 
There were no changes in hematocrit, hemoglobin concentration, or ALAD 
activity. The only significant difference between no-shot, steel, and 
TP males in any of the 25 plasma chemistry parameters at day 15 was an 
increase in the albumin/globulin ratio in the TP birds when compared to 
the other two groups, but the authors felt this was not remarkable. 
Three TP-dosed males developed mild biliary stasis. The authors 
attributed this to the intubating of mallards with 8 BBs of TP shot 
inducing a pathological condition, however, slight, that is not found 
in the control birds. No other histopathological lesions were found. In 
general, no adverse effects were seen in mallards

[[Page 40076]]

given 8 BB-size TP shot and monitored over a 30-day period. Tungsten 
was detected in the femur of 2 TP-dosed females and the kidneys of 2 
TP-dosed birds; in both tissues, concentrations were only slightly 
above detection limits.
    Based on the results of the toxicological report and the toxicity 
test (Tier 1 and 2), the Service concludes that TP shot (95.5 percent 
tungsten and 4.5 percent Nylon 6 or 11, by weight with <1 percent 
residual lead), does not pose a significant danger to migratory birds 
or other wildlife and their habitats. However, the Service has 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 Yukon-Kuskokwim (Y-K) Delta, Alaska. Until a 
reproductive/chronic toxicity test has been completed and the Service 
has reviewed the results, TP 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)(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 TP shot is nontoxic to waterfowl and their offspring.
    The second condition of approval is testing for residual lead 
levels. Any TP shot with lead levels equal to or exceeding 1 percent 
will be considered toxic and, therefore, illegal. In the August 18, 
1995, Federal Register (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).
    The third condition of 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 TP shot from lead shot. Furthermore, TP 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 approving 
temporary approval of TP shot as nontoxic for migratory bird hunting, 
except in the Yukon-Kuskokwim (Y-K) Delta, Alaska. It is based on the 
original request made to the Service by Federal Cartridge Company on 
July 16, 1997, the toxicological report, and acute toxicity study. 
Results of the toxicological report and 30-day toxicity test undertaken 
for Federal Cartridge Company document the apparent absence of any 
deleterious effects of TP shot when ingested by captive-reared mallards 
or to the ecosystem.
References
Barr Engineering Company. 1996. Toxicology report on new shot. 
Contract Report 2302118/40970091/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-polymer shot in game-farm mallards. 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. Journal of Wildlife Management 32(3):483-488.
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. Journal of Wildlife Diseases 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, W. L. Bryden, G. S. Heard, and D. Balnave. 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 Edition.
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. Colorado Division of 
Wildlife, 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 provide approval of TP shot as nontoxic for 
migratory bird hunting 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 proposed rule, which stated the 
``use of tungsten-polymer shot is not likely to adversely affect listed 
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

[[Page 40077]]

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 estimated that migratory bird hunters would spend 
between $254 and $592 million at small businesses in 1996. The approval 
of tungsten-polymer 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 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. 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 governments 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.

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. Section 20.21 is amended by revising paragraph (j) introductory 
text and adding paragraph (j)(3) to read as follows:


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 part tungsten: 4.5 parts 
Nylon 6 or 11 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:
* * * * *
    (3) Tungsten-polymer shot (95.5 parts tungsten: 4.5 parts Nylon 6 
or 11 with <1 percent residual lead) is legal as nontoxic shot for the 
1998-99 migratory bird hunting season, except for the Yukon-Kuskokwim 
Delta habitat in Alaska.

    Dated: July 14, 1998.
Donald J. Barry,
Assistant Secretary for Fish and Wildlife and Parks.
[FR Doc. 98-19890 Filed 7-24-98; 8:45 am]
BILLING CODE 4310-55-P