03-518. Migratory Bird Hunting; Approval of Tungsten-Iron-Nickel-Tin Shot as Nontoxic for Hunting Waterfowl and Coots

AGENCY:

Fish and Wildlife Service, Interior.

ACTION:

Final rule.

SUMMARY:

We approve shot formulated of 65% tungsten, 10.4% iron, 2.8% nickel, and 21.8% tin as nontoxic for hunting waterfowl and coots. We assessed possible effects of the tungsten-iron-nickel-tin (TINT) shot, and we believe that it does not present a significant toxicity threat to wildlife or their habitats and that further testing of the shot is not necessary. Approval of this shot provides another nontoxic option for hunters.

DATES:

This rule takes effect on January 10, 2003.

ADDRESSES:

Copies of the Environmental Assessment are available from the Chief of the Division of Migratory Bird Management, U.S. Fish and Wildlife Service, 4401 North Fairfax Drive, Room 634, Arlington, Virginia 22203-1610.

FOR FURTHER INFORMATION CONTACT:

Bob Blohm, Acting Chief, or John J. Kreilich, Jr., Division of Migratory Bird Management, 703-358-1714.

SUPPLEMENTARY INFORMATION:

The Migratory Bird Treaty Act of 1918 (Act) (16 U.S.C. 703B-712 and 16 U.S.C. 742 a-j) implements migratory bird treaties between the United States and Great Britain for Canada (1916 and 1996 as amended), Mexico (1936 and 1972 as amended), Japan (1972 and 1974 as amended), and Russia (then the Soviet Union, 1978). These treaties protect certain migratory birds from take, except as permitted under the Act. The Act authorizes the Secretary of the Interior to regulate take of migratory birds in the United States. Under this authority, the Fish and Wildlife Service controls the hunting of migratory game birds through regulations in 50 CFR part 20.

Since the mid-1970s, we have sought to identify shot that is not significantly toxic to migratory birds or other wildlife. Compliance with the use of nontoxic shot has increased over the last few years (Anderson et al. 2000), and we believe that it will continue to increase with the approval and availability of other nontoxic shot types. Currently, steel, bismuth-tin, tungsten-iron, tungsten-polymer, tungsten-matrix, and tungsten-nickel-iron shot are approved as nontoxic.

The purpose of this rule is to approve the use of TINT shot in the tested formulation (65% tungsten, 10.4% iron, 2.8% nickel, and 21.8% tin by weight) for waterfowl and coot hunting. This rule amends 50 CFR 20.21(j), which describes prohibited types of shot for waterfowl and coot hunting, to allow the use of this shot.

Background

On October 12, 2001, we received an application (Tier 1) under 50 CFR 20.134 from ENVIRON-Metal, Inc. for approval of HEVI-SHOT^TM brand of Soft Shot in a 65% tungsten, 10.4% iron, 2.8% nickel, and 21.8% tin formulation. The application included information on chemical characterization, production variability, use volume, toxicological effects, environmental fate and transport, and evaluation. In accordance with our regulation, on May 10, 2002, we published in the Federal Register a proposed rule indicating our intention to approve TINT shot. We have reviewed the Tier 1 application, the supporting data, and the public comment, and the Director, U.S. Fish and Wildlife Service, has concluded that this shot does not impose a significant danger to migratory birds and other wildlife or their habitats.

In addition, since the 2000-2001 hunting season is completed, tin (99.9 percent tin with 1 percent residual lead) shot is no longer authorized for use and therefore the reference to it in 50 CFR 20.21(j) is deleted.

Toxicity Information

Tungsten may be substituted for molybdenum in enzymes in mammals. Ingested tungsten salts reduce growth and can cause diarrhea, coma, and death in mammals (Bursian et al. 1996, Cohen et al. 1973, Karantassis 1924, Kinard and Van de Erve 1941, National Research Council 1980, Pham-Huu-Chanh 1965), but elemental tungsten is virtually insoluble and therefore essentially nontoxic. A dietary concentration of 94 parts-per-million (ppm) did not reduce weight gain in growing rats (Wei et al. 1987). Lifetime exposure to 5 ppm tungsten as sodium tungstate in drinking water produced no discernible adverse effects in rats (Schroeder and Mitchener 1975). At 100 ppm tungsten as sodium tungstate in drinking water, rats had decreased enzyme activity after 21 days (Cohen et al. 1973).

Chickens given a complete diet showed no adverse effects of 250 ppm sodium tungstate administered for 10 days in the diet. However, 500 ppm in the diet had detrimental effects on day-old chicks (Teekell and Watts 1959). Adult hens had reduced egg production and egg weight on a diet containing 1,000 ppm tungsten (Nell et al. 1981a). EPT (1999) concluded that 250 ppm in the diet would produce no observable adverse effects. Kelly et al. (1998) demonstrated no adverse effects on mallards dosed with tungsten-iron or tungsten-polymer shot according to nontoxic shot test protocols.

Most toxicity tests reviewed were based on soluble tungsten compounds rather than elemental tungsten. As we found in our reviews of other tungsten shot types, we have no basis for concern about the toxicity of the tungsten in TINT shot to fish, mammals, or birds.

Nickel is a dietary requirement of mammals, with necessary consumption set at 50 to 80 parts per billion for the rat and chick (Nielsen and Sandstead 1974). Though it is necessary for some enzymes, nickel can compete with calcium, magnesium, and zinc for binding sites on many enzymes. Water-soluble nickel salts are poorly absorbed if ingested by rats (Nieboer et al. 1988). Nickel carbonate caused no treatment effects in rats fed 1,000 ppm for 3 to 4 months (Phatak and Patwardhan 1950). Rats fed 1,000 ppm nickel sulfate for 2 years showed reduced body and liver weights, an increase in the number of stillborn pups, and decrease in weanling weights through three generations (Ambrose et al. 1976). Nickel chloride was even more toxic; 1,000 ppm fed to young rats caused weight loss in 13 days (Schnegg and Kirchgessner 1976).

Soluble nickel salts are toxic to mammals, with an oral LD₅₀ (lethal dose) of 136 mg/kg in mice, and 350 mg/kg in rats (Fairchild et al. 1977). Nickel catalyst (finely divided nickel in vegetable oil) fed to young rats at 250 ppm for 16 months, however, produced no detrimental effects (Phatak and Patwardhan 1950).

In chicks from hatching to 4 weeks of age, 300 ppm nickel as nickel carbonate or nickel acetate in the diet produced no observed adverse effects. However, concentrations of 500 ppm or more reduced growth (Weber and Reid 1968). A diet containing 200 ppm nickel as nickel sulfate had no observed effects on mallard ducklings from 1 to 90 days of age. Diets of 800 ppm or more caused significant changes in physical condition of the ducklings (Cain and Pafford 1981). Eastin and O'Shea (1981) observed no apparent significant changes in pairs of breeding mallards fed diets containing up to 800 ppm nickel as nickel sulfate for 90 days. We have no basis for concern about the toxicity of nickel in TINT shot to fish, mammals, or birds.

Iron is an essential nutrient, so reported iron toxicosis in mammals, such as livestock, is primarily a phenomenon of overdosing. Maximum recommended dietary levels of iron range from 500 ppm for sheep to 3,000 ppm for pigs (National Research Council [NRC] 1980). Chickens require at least 55 ppm iron in the diet (Morck and Austic 1981). Chickens fed 1,600 ppm iron in an adequate diet displayed no ill effects (McGhee et al. 1965), and turkey poults fed 440 ppm in the diet also suffered no ill effects. The tests in which eight No. 4 tungsten-iron shot were administered to each mallard in a toxicity study indicated that the 45% iron content of the shot had no adverse effects on the test animals (Kelly et al. 1998). We have no basis for concern about the toxicity of iron in TINT shot to fish, mammals, or birds.

Elemental and inorganic tins have low toxicity, due largely to low absorption rate, low tissue accumulation, and rapid excretion rates. Inorganic tin is only slightly to moderately toxic to mammals. The oral LD₅₀ values for tin (II) chloride for mice and rats are 250 and 700 mg/kg of body weight, respectively (WHO 1980).

A 150-day chronic toxicity/reproductive study conducted for tin shot revealed no adverse effects in mallards dosed with eight No. 4 sized shot. There were no significant changes in egg production, fertility, or hatchability of birds dosed with tin when compared to steel-dosed birds (Gallagher et al. 2000).

Environmental Fate

Elemental tungsten and iron are virtually insoluble in water and do not weather or degrade in the environment. Tungsten is stable in acids and does not easily form compounds with other substances. Preferential uptake by plants in acidic soil suggests uptake of tungsten when it has formed compounds with other substances rather than when it is in its elemental form (Kabata-Pendias and Pendias 1984).

Nickel is common in fresh waters, though usually at concentrations of less than 1 part per billion in locations unaffected by human activities. Pure nickel is not soluble in water. Free nickel may be part of chemical reactions, such as sorption, precipitation, and complexation. Reactions of nickel with anions are unlikely. Complexation with organic agents is poorly understood (U.S. Environmental Protection Agency [EPA] 1980). Water hardness is the dominant factor governing nickel effects on living things (Stokes 1988).

Tin occurs naturally in soils at 2 to 200 mg/g with areas of enrichment at much higher concentrations (up to 1,000 mg/g) (WHO 1980). However, in the United States, soil concentrations are between 1 and 5 ppm (Kabata-Pendias and Pendias 2001).

Environmental Concentrations

Calculation of the estimated environmental concentration (EEC) of a candidate shot in a terrestrial ecosystem is based on 69,000 shot per hectare (2.47 acre) (Bellrose 1959, 50 CFR 20.134). Assuming complete dissolution of the shot, the EEC for tungsten in soil is 15.09 mg/kg. The EECs for nickel and iron would be 0.65 and 2.41 mg/kg, respectively. The EEC for nickel (the only one of the four elements with an application limit) is substantially below the U.S. Environmental Protection Agency (EPA) biosolid application limit. The 0.65 mg/kg EEC for nickel also is far below the 16 to 35 mg/kg concentrations suggested as minimum sediment concentrations at which effects of the metal are likely to occur (EPA 1997, Ingersoll et al. 1996, Long and Morgan 1991, MacDonald et al. 2000, Smith et al. 1996). The EEC for tungsten from TINT shot is below that for the already-approved TNI shot. The EEC for iron is less than 0.01% of the typical background concentration, and the iron is in an insoluble form. The EEC for tin in soil is 5.06 mg/kg, one order of magnitude smaller than the 50 mg/kg suggested maximum concentration in surface soil tolerated by plants (Kabata-Pendias and Pendias 2001).

Calculation of the EEC in an aquatic ecosystem assumes complete erosion of 69,000 shot in one hectare (2.47 acre) of water 1 foot deep. The EECs for the elements in TINT shot in water are 3,218 μg/L for tungsten, 515 μg/L for iron, 139 μg/L for nickel, and 1,079 μg/L for tin. We concluded that a tungsten concentration of 10,500 μg/L posed no threat to aquatic life (62 FR 4877). The EEC for nickel from TINT shot is below the EPA acute water quality criterion of 1,400 μg/L in fresh water, but would exceed the 75 μg/L criterion for salt water. However, tests showed that corrosion of TINT shot occurs at very low rates. The amount of nickel liberated into seawater by eight No. 4 TINT shot for a 30-day exposure was 23% of the amount liberated by TNI. TINT shot is predicted to release 1.8 μg/L of nickel into 1 ha-ft of seawater over 1 year. This value is 2.4% of the acute criterion and less than 23% of the chronic criterion.

The EEC for iron is below the chronic criterion for protection of aquatic life and for tin; it is four times less than the Minnesota Water Quality Standard. Previous assessments of tungsten demonstrated dissolution at a rate of 10.5 mg/L (equal to 10,500 μg/L) and concluded no risk to aquatic life (62 FR 4877). The EEC of tungsten from TINT shot is 3,218 μg/L. This level is three times less than the 10,500 μg/L level previously mentioned.

Effects on Birds

Kraabel et al. (1996) surgically embedded tungsten-bismuth-tin shot in the pectoralis muscles of ducks to simulate wounding by gunfire and to test for toxic effects of the shot. The shot neither produced toxic effects nor induced adverse systemic effects in the ducks during the 8-week period of their study.

Nell et al. (1981a) fed laying hens (Gallus domesticus) 0.4 or 1.0 g/kg tungsten in a commercial mash for 5 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. 1981b). 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 ppm in the liver.

A 150-day chronic toxicity/reproductive study conducted for tin shot revealed no adverse effects in mallards dosed with eight No. 4 sized shot. In this investigation, there were no significant changes in egg production, fertility, or hatchability of birds dosed with tin when compared to steel-dosed birds (Gallagher et al. 2000).

Toxicity Studies

Ringelman et al. (1993) conducted a 32-day acute toxicity study that involved dosing game-farm mallards with tungsten-bismuth-tin shot in a relative composition of 39%, 44.5%, and 16.5% by weight, respectively. No dosed birds died during the trial, and their behavior was normal. Post-euthanization examination of tissues revealed no toxicity or damage related to shot exposure. Blood calcium differences between dosed and undosed birds were judged as unrelated to shot exposure. That study indicated that tungsten presented little hazard to waterfowl.

The Tier 1 application of TINT shot included analyses comparing corrosion data of TNI shot to TINT shot. Samples of both shot types were exposed to seawater for 10.8 days. The two seawater samples were then analyzed for nickel, iron, tungsten, and tin. Samples were then returned to fresh seawater and exposed for an additional 44.5 days, whereupon the seawater solutions were again analyzed for nickel, iron, tungsten, and tin.

The total release of nickel from TINT shot over the 55.3-day exposure was only 13% that of TNI shot. The results indicate that TINT shot shows lower rates of nickel release due to the collection of corrosive materials on surfaces that inhibit additional corrosion.

Assuming that a duck eats 10 No. 4 TINT shot in 1 day and that the shot are completely eroded in the gizzard in 24 hours, the duck would be exposed to .061g of nickel. This amount is slightly more than half of the .102g/day that Eastin and O'Shea (1981) found produced no ill effects on mallards. We believe, therefore, that consumption of nickel from TINT shot is unlikely to have detrimental effects on waterfowl.

Ingestion by Fish, Amphibians, Reptiles, or Mammals

Based on the best available information and past reviews of tungsten-based and tin shot, we expect no detrimental effects due to tungsten, iron, or tin on animals that might ingest TINT shot. We know of no studies of ingestion of nickel by reptiles or amphibians. The exposure of nickel to any animal in these taxa that might consume a TINT shot pellet would be lower, because the pellet likely would not be retained in most animals that might consume one. Their exposure to nickel would therefore be much lower than the worst-case scenario for waterfowl.

Nontoxic Shot Approval

The first condition for nontoxic shot approval is toxicity testing, Tiers 1, 2, or 3 (50 CFR § 20.134). Based on the results of past toxicity tests, we conclude that TINT shot does not pose a significant danger to migratory birds, other wildlife, or their habitats.

The second condition for approval is testing for residual lead levels. We determined that the maximum environmentally acceptable level of lead in shot is 1% (50 CFR § 20.134(b)(5)). ENVIRON—Metal, Inc. has documented that TINT shot meets this requirement.

The third condition for approval involves enforcement. Approval of any nontoxic shot is contingent upon the development and availability of a noninvasive field testing device (50 CFR § 20.134(b)(6)). TINT shotshells can be drawn to a magnet as a simple field detection method.

Public Comments

We received two comments on the May 10, 2002 proposed rule (67 FR 31754) to approve TINT shot for hunting waterfowl and coots. Both comments supported granting approval for use of the shot.

References

Anderson, W. L., S. P. Havera, and B. W. Zercher. 2000. Ingestion of lead and nontoxic shotgun pellets by ducks in the Mississippi flyway. Journal of Wildlife Management 64:848-857.

Ambrose, P., P. S. Larson, J. F. Borzelleca, and G. R. Hennigar, Jr. 1976. Long term toxicologic assessment of nickel in rats and dogs. Journal of Food Science and Technology 13:181-187.

Bellrose, F. C. 1959. Lead poisoning as a mortality factor in waterfowl populations. Illinois Natural History Survey Bulletin 27(3): 235-288.

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 Company. 71 pages.

Cain, B. W. and E. A. Pafford. 1981. Effects of dietary nickel on survival and growth of mallard ducklings. Archives of Environmental Contamination and Toxicology 10:737-745.

Cohen, H. J., R. T. Drew, J. L. Johnson, and K. V. Rajagopalan. 1973. Molecular basis of the biological function of molybdenum: the relationship between sulfite oxidase and the acute toxicity of bisulfate and SO₂. Proceedings of the National Academy of Sciences 70:3655-3659.

Eastin, W. C., Jr. and T. J. O'Shea. 1981. Effects of dietary nickel on mallards. Journal of Toxicology and Environmental Health 7:883-892.

Ecological Planning and Toxicology, Inc. 1999. Application for approval of t-n-i metal^TM nontoxic shot: Tier 1 report. Cherry Hill, New Jersey. 28 pages plus appendixes.

Fairchild, E. J., R. J. Lewis, and R. L. Tatken (editors). 1977. Registry of toxic effects of chemical substances, Volume II. Pages 590-592. U.S. Department of Health, Education, and Welfare Publication (NIOSH) 78-104B. 227 pages.

Gallagher, S.P., J.B. Beavers, R. Van Hoven, M. Jaber. 2000. Pure tin shot: A chronic exposure study with the mallard including reproductive parameters. Wildlife International, Ltd. Project No. 476-102. Easton, Maryland. 322pp.

Ingersoll, C. G., P. S. Haverland, E. L. Brunson, T.J. Canfield, F. J. Dwyer, C. E. Henke, N. E. Kemble, and D. R. Mount. 1996. Calculation and evaluation of sediment effect concentrations for the amphipod Hyalella azteca and the midge Chironomus riparius. EPA 905-R96-008, Great Lakes National Program Office, Region V, Chicago, Illinois. Mixed pagination.

Kabata-Pendias, A. and H. Pendias. 1984. Trace elements in soils and plants. CRC Press, Inc. Boca Raton, FL. 315 pages.

Kabata-Pendias, A. and H. Pendias. 2001. Trace elements in soils and plants. 3rd edition. CRC Press, Inc. Boca Raton, FL. 411 pages.

Karantassis, T. 1924. On the toxicity of compounds of tungsten and molybdenum. Annals of Medicine 28:1541-1543.

Kelly, M. E., S. D. Fitzgerald, R. J. Aulerich, R. J. Balander, D. C. Powell, R. L. Stickle. W. Stevens, C. Cray, R. J. Tempelman, and S. J. Bursian. 1998. Acute effects of lead, steel, tungsten-iron and tungsten-polymer shot administered to game-farm mallards. Journal of Wildlife Diseases 34:673-687.

Kinard, F. W. and J. Van de Erve. 1941. The toxicity of orally-ingested tungsten compounds in the rat. Journal of Pharmacology and Experimental Therapeutics 72:196-201.

Kraabel, F. W., M. W. Miller, D. M. Getzy, and J. K. Ringelman. 1996. Effects of embedded tungsten-bismuth-tin shot and steel shot on mallards. Journal of Wildlife Diseases 38:1-8.

Long, E. R. and L. G. Morgan. 1991. The potential for biological effects of sediment-sorbed contaminants tested in the National Status and Trends Program. NOAA Technical Memorandum NOS OMA 52, National Oceanic and Atmospheric Administration, Seattle, Washington. 175 pages + appendices.

MacDonald, D. D., C. G. Ingersoll, and T. A. Berger. 2000. Development and evaluation of consensus-based sediment quality guidelines for freshwater ecosystems. Archives of Environmental Contamination and Toxicology 39:20-31.

McGhee, F., C. R. Creger, and J. R. Couch. 1965. Copper and iron toxicity. Poultry Science 44:310-312.

Morck, T. A. and R. E. Austic. 1981. Iron requirements of white leghorn hens. Poultry Science 60:1497-1503.

National Research Council. 1980. Mineral tolerance of domestic animals. National Research Council, National Academy of Sciences, Washington, DC. 577 pages.

Nell, J. A., W. L. Bryden, G. S. Heard, and D. Balnave. 1981a. Reproductive performance of laying hens fed tungsten. Poultry Science 60:257-258.

Nell, J. A., E. F. Annison, and D. Balnave. 1981b. The influence of tungsten on the molybdenum status of poultry. British Poultry Science 21:193-202.

Nieboer, E., R. T. Tom, and W. E. Sanford. 1988. Nickel metabolism in man and animals. Pages 91-122 in Metal ions in biological systems, volume 23: nickel and its role in biology. H. Sigel and A. Sigel, editors. Marcel Dekker, New York.

Nielsen, F. H. and H. H. Sandstead. 1974. Are nickel, vanadium, silicon, fluoride, and tin essential for man? American Journal of Clinical Nutrition 27:515-520.

Pham-Huu-Chanh. 1965. The comparative toxicity of sodium chromate, molybdate, tungstate, and metavanadate. Archives Internationales de Pharmacodynamie et de Therapie 154:243-249.

Phatak, S. S. and V. N. Patwardhan. 1950. Toxicity of nickel. Journal of Science and Industrial Research 9B:70-76.

Ringelman, J. K., M. W. Miller, and W. F. Andelt. 1993. Effects of ingested tungsten-bismuth-tin shot on captive mallards. Journal of Wildlife Management 57:725-732.

Schnegg, S. and M. Kirchgessner. 1976. [Toxicity of dietary nickel]. Landwirtsch. Forsch. 29:177. Cited in Chemical Abstracts 86:101655y (1977).

Schroeder, H. A. and M. Mitchener. 1975. Life-term studies in rats: effects of aluminum, barium, beryllium, and tungsten. Journal of Nutrition 105:421.

Smith, S. L., D. D. MacDonald, K. A. Keenleyside, C. G. Ingersoll, and J. Field. 1996. A preliminary evaluation of sediment quality assessment values for freshwater ecosystems. Journal of Great Lakes Research 22:624-638.

Stokes, P. 1988. Nickel in aquatic systems. Pages 31-46 in Metal ions in biological systems, volume 23: nickel and its role in biology. H. Sigel and A. Sigel, editors. Marcel Dekker, New York.

Teekel, R. A. and A. B. Watts. 1959. Tungsten supplementation of breeder hens. Poultry Science 38:791-794.

U.S. Environmental Protection Agency. 1980. Ambient water quality criteria for nickel. U.S. Environmental Protection Agency, Washington, DC. 207 pages.

U.S. Environmental Protection Agency. 1997. The incidence and severity of sediment contamination in surface waters of the United States: National sediment quality survey, Volume 1. EPA 823-R-97-006. Office of Science and Technology, Washington, DC. 182 pages plus appendices.

Weber, C. W. and B. L. Reid. 1968. Nickel toxicity in growing chicks. Journal of Nutrition 95:612-616.

Wei, H. J., X-M. Luo, and X-P. Yand. 1987. Effects of molybdenum and tungsten on mammary carcinogenesis in Sprague-Dawley (SD) rats. Chung Hua Chung Liu Tsa Chih 9:204-7. English abstract.

WHO [World Health Organization]. 1980. Tin and organotin compounds. A preliminary review. Environmental Health Criteria 15. World Health Organization. Geneva. 109pp.

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), we have prepared an Environmental Assessment (EA) for approval of TINT shot. The EA is available to the public at the location indicated in the ADDRESSES section.

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 Ainsure 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 * * *” We have completed a Section 7 consultation under the ESA for this rule. The result of our consultation under Section 7 of the ESA is available to the public at the location indicated in the ADDRESSES section.

Executive Order 12866

This rule is not a significant regulatory action subject to OMB review under Executive Order 12866. OMB makes the final determination under E.O. 12866.

a. This rule will not have an annual economic effect of $100 million or adversely affect an economic sector, productivity, jobs, the environment, or other units of government. A cost-benefit and economic analysis is not required.

b. This rule will not create inconsistencies with other agencies' actions because the Service is the sole agency responsible for regulating activities under the Migratory Bird Treaty Act.

c. This rule will not materially affect entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients because it has no mechanism to affect entitlements, grants, user fees, loan programs or the rights and obligations of their recipients.

d. This rule will not raise novel legal or policy issues because the Service has already approved six other nontoxic shot types.

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 economic impact on a substantial number of small entities, which includes small businesses, organizations, or governmental jurisdictions. This rule approves an additional type of nontoxic shot that may be sold and used to hunt migratory birds; this rule provides one shot type in addition to the existing six that are approved. We have determined, however, that 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. We anticipate no dislocation or other local effects, with regard to hunters and others.

Small Business Regulatory Enforcement Fairness Act

Similarly, this rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act.

a. This rule does not have an annual effect on the economy of $100 million or more.

b. This rule will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions. This rule does not deal with traded commodities and, therefore, does not have an impact on prices for consumers.

c. This rule does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

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. We have examined this regulation under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) and found it to contain no information collection requirements.

Unfunded Mandates Reform Act

We have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502, et seq., that this rule-making will not impose a cost of $100 million or more in any given year on local or State government or private entities. This rule does not impose an unfunded mandate of more than $100 million per year or have a significant or unique effect on State, local, or tribal governments or the private sector because it is the Service's responsibility to regulate the take of migratory birds in the United States.

Civil Justice Reform—Executive Order 12988

We have determined 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, this rule, authorized by the Migratory Bird Treaty Act, does not have significant takings implications and does not affect any constitutionally protected property rights. This rule will not result in the physical occupancy of property, the physical invasion of property, or the regulatory taking of any property. In fact, this rule will allow hunters to exercise privileges that would be otherwise unavailable and, therefore, reduces 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. This rule does 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 13132, this proposed regulation does not have significant federalism effects and does 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) Executive Order 13175, and 512 DM 2, we have determined that this rule has no effects on Federally recognized Indian tribes.

Energy Effects

In accordance with Executive Order 13211, this rule, authorized by the Migratory Bird Treaty Act, does not significantly affect energy supply, distribution, and use. This rule is not a significant energy action and no Statement of Energy Effects is required.

Effective Date

Under the Administrative Procedure Act (5 U.S.C. 551-553), our normal practice is to publish rules with a 30-day delay in effective date. In this case, however, we use the “good cause” exemption under 5 U.S.C. 553(d)(3) to make this rule effective upon publication. This rule relieves a restriction, and it is not in the public interest to delay its effective date.

List of Subjects in 50 CFR Part 20

• Exports
• Hunting
• Imports
• Reporting and recordkeeping requirements
• Transportation
• Wildlife

For the reasons discussed in the preamble, we 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; 16 U.S.C. 742 a-j, Pub. L. 106-108.

2. In § 20.21, revise paragraph (j) to read as follows:

§ 20.21

What hunting methods are illegal?

* * * * *

(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 (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 tungsten-nickel-iron (50% tungsten: 35% nickel: 15% iron with <1 percent residual lead) shot, or tungsten-iron-nickel-tin (65% tungsten: 10.4% iron: 2.8% nickel: 21.8% tin 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 this restriction applies only to the taking of Anatidae (ducks, geese, (including brant) and swans), coots (Fulica americana) and any species that make up aggregate bag limits during concurrent seasons with the former in areas described in § 20.108 as nontoxic shot zones.

Dated: December 11, 2002.

Craig Mason,

Assistant Secretary for Fish and Wildlife and Parks.