[Federal Register Volume 61, Number 18 (Friday, January 26, 1996)]
[Proposed Rules]
[Pages 2470-2477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1179]



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DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

50 CFR Part 20

RIN 1018-AB80


Migratory Bird Hunting: Amended Test Protocol for Nontoxic Shot 
Approval Procedures for Shot and Shot Coatings

AGENCY: Fish and Wildlife Service, Interior.

ACTION: Proposed rule.

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SUMMARY: The principal purpose of this action is to promulgate a 
rulemaking that will update and amend the current nontoxic shot 
approval procedures by establishing a 3-tiered approval process. Shot 
approval will be considered at each tier with the testing becoming 
progressively more demanding. An environmentally benign shot could be 
granted approval at the first tier. This process is designed to include 
both candidate shot and shot coatings.

DATES: Comments on this proposal must be received by March 26, 1996.

ADDRESSES: Comments regarding this notice should be addressed to: 
Director (FWS/MBMO), U.S. Fish and Wildlife Service, 634 ARLSQ, 1849 C 
St., NW., Washington, DC 20240. Comments received on this notice will 
be available for public inspection during normal business hours in Room 
634, Arlington Square Building, 4401 No. Fairfax Drive, Arlington, VA 
22203.

FOR FURTHER INFORMATION CONTACT: Paul Schmidt, Chief, or Keith 
Morehouse, Staff Specialist, Office of Migratory Bird Management, 703/
358-1714.

SUPPLEMENTARY INFORMATION: The Service is proposing to revise and 
update the existing nontoxic shot approval procedures by establishing a 
3-tiered approval process. Shot approval will be considered at each 
tier with the testing becoming progressively more demanding. An 
environmentally benign shot could be granted approval at the first 
tier. This approval process is designed to include both candidate shot 
and shot coatings. The Service and applicant have concluded much of the 
currently identified nontoxic testing required for bismuth-tin shot and 
the process was shown to be both confusing and cumbersome. The Service 
believes that this procedure needs to be modified because:
    1. From an ecosystem management standpoint, species in addition to 
waterfowl species need to be considered;
    2. Since the original regulations were promulgated, important 
advances have occurred in the field of ecological risk assessment that 
can be applied to this process;
    3. Time, expense and burden on applicants and the Federal 
Government can be reduced without risk to wildlife; and
    4. From an animal welfare standpoint, the numbers of test animals 
used can be reduced.
    It should be noted, however, that while these procedures were put 
in place in 1986, the Service had not had any submission requesting 
approval of nontoxic shot until the bismuth-tin shot application of 
1994. From our experience with the bismuth-tin shot approval process, 
it has been determined that procedures should be modified to 
accommodate situations where less than full testing is indicated. Thus, 
the Service and the National Biological Service (NBS) have 
cooperatively developed an alternative draft set of procedures proposed 
to be used for approving nontoxic shot as well as coatings that would 
replace the testing requirements presently contained in Sec. 20.134. As 
with the current procedures, the proposed set of approval procedures 
carries the assumption that the applicant has the burden of proof that 
the candidate coating or shot is nontoxic.
    The system proposed is 3-tiered and is meant to gradually increase 
the difficulty of the level of testing based on a test-in/test-out 
principle. That is, those candidate materials not approved as a result 
of subjecting them to the standards set at Tier 1 would be subjected to 
the standards of Tier 2, and so forth, i.e., test-in. If the candidate 
material is approved at Tier 1 there would be no requirement to proceed 
to Tier 2 or 3, i.e., test-out. The criteria for requiring testing 
under Tier 2 standards would be met if data is incomplete or 
inconclusive as a result of review of materials and analyses conducted 
at Tier 1. Similarly, the criterion for requiring testing under Tier 3 
standards would be met if material is found to have some poorly defined 
level of toxic effects at Tier 2.
    As currently proposed by this regulation, Tier 1 would set out 
comprehensive and detailed requirements that must be provided to the 
Service in order for the Service to grant approval. Based on the 
Service's evaluation of whatever Tier 1 information could be gathered, 
the Service would make a decision to grant approval or require Tier 2 
testing. That is, the scope of the new procedures outlined in Tier 1 
would include: (1) Statements of use, chemical characterization, 
production variability and volume of use. The Service would request the 
specifics on the chemical compound(s) to be used and a complete 
analysis of potential environmental toxicity, as well as the thickness 
in the case of coating(s) and percentage of the coating in comparison 
to the total shot weight; (2) information on the toxicological effects 
of the material, including an ecological risk assessment on the 
toxicological effects of the coating and an assessment explaining why 
the applicant believes the coating or base material(s) does not pose 
toxicity problems for wildlife; and (3) information on the 
environmental fate and transport of the material. The Service would 
seek information on changes, if any, that are produced by firing the 
shot, the estimated half-life of the material and estimates of the 
environmental concentrations that are apt to be expected. Tier 1 
procedures also contain a set of requirements defining the Service's 
responsibility in evaluating the submitted data/information.
    Previously codified candidate shot testing procedures would be 
divided between Tiers 2 and 3, with the in vitro erosion rate testing 
and the short-term (30-day) acute toxicity testing part of Tier 2, and 
the chronic exposure under adverse conditions and the chronic exposure 
reproduction testing part of Tier 3. Tier 2 will also include a test 
protocol that would assess the potential for the candidate shot to 
affect aquatic organisms, such as fish and/or 

[[Page 2471]]
invertebrates, although it may not require in vivo testing, per se.
    Applicants would be required to provide the Service with all the 
required information at the time of application or processing would be 
delayed. The information provided by the applicant will allow the 
Service, or others, to conduct an independent analysis and to make an 
informed decision on approval.
    A schematic representation of the approval process is provided here 
to aid the reader:

BILLING CODE 4310-55-P
      

[[Page 2472]]
    [GRAPHIC] [TIFF OMMITTED] TP26JA96.000
    


BILLING CODE 4310-55-C

[[Page 2473]]

    Although this new set of proposed approval procedures appears to be 
more lengthy, the Service feels that it is more flexible and simplifies 
the approval process. It is intended that these proposed changes will 
allow materials that are somewhat innocuous, with regard to known 
toxicity, to be processed more quickly, at lower cost and with less 
paperwork for both the applicant and the Service while ensuring that 
natural resources are protected.
    In 50 CFR 20.134, the Service provides a procedure for approval of 
nontoxic shot which has been in effect since 1986; however, it was not 
clear that this procedure also pertained to the shot coating which is 
applied to prevent corrosion and potential fusion of the shot. Shot 
coatings were not given consideration since they are typically quite 
thinly applied and constitute a small percent of the pellet by weight. 
Nonetheless, the Service is concerned that the coating, although 
present in small amounts, may in and of itself be toxic and pose a 
hazard to migratory birds or other wildlife. Therefore, the Service is 
proposing by this regulation to codify its informal policy on approval 
of the types of shot coatings with which a waterfowler may hunt and to 
establish a process for that approval.
    Earlier, the Service responded to a request from industry and 
approved the use of both copper and nickel coatings for steel shot used 
in waterfowl hunting. This request specified that coating thickness 
would be, nominally, 2 ten-thousandths of an inch thick (0.0002'') and 
1 percent or less of the total weight of the shot. These two coatings 
had been the only ones approved for waterfowling since May, 1986. More 
recently, the Service received a request to approve zinc as a coating 
and learned, in the process of acquiring more information, that one 
ammunition manufacturer was already marketing a zinc coated steel shot 
and another had been planning to market a zinc coated steel shot for, 
what was then, an upcoming season (1993-94). Apparently, despite past 
efforts to publicize the information, there was no recognition of the 
Service's role in this aspect of nontoxic shot regulation in some 
quarters and a definite recognition of that role in others. Thus, the 
Service perceives there is a need to incorporate into this regulation 
standards which allow only approved coatings on pellets utilized in 
waterfowl hunting.
    In summary, the principal purpose of this action is to promulgate a 
rulemaking that will update and amend the current nontoxic shot 
approval procedures to include both candidate nontoxic shot and 
nontoxic shot coatings.

NEPA Consideration

    Pursuant to 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 will comply with NEPA prior to adopting a 
final rule.

Endangered Species Act Considerations

    Section 7 of the Endangered Species Act (ESA), as amended (16 
U.S.C. 1531-1543; 87 Stat. 884), 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 * * *'' Consequently, the Service will initiate 
Section 7 consultation under the ESA for this proposed rulemaking to 
amend the nontoxic shot and shot coating approval process. When 
completed, the results of the Service's consultation under Section 7 of 
the ESA may be inspected at, and will be available from, the Office of 
Migratory Bird Management, U.S. Fish and Wildlife Service, Department 
of the Interior, Washington, DC 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 and/or governmental 
jurisdictions. However, since this is an amendment to existing 
procedures and is designed to reduce the cost and time that is required 
to determine the toxicity of a candidate shot, this rule will have no 
significant effect on small entities. No dislocation or other local 
effects, with regard to hunters and others, are apt to be evidenced. 
This rule was not subject to Office of Management and Budget (OMB) 
review under Executive Order 12866. This rule does not contain any 
additional information collection efforts requiring approval by the OMB 
under Public Law 104-13. This rule is being promulgated under existing 
Office of Management and Budget information collection requirements 
clearance number 1018-0067.

Authorship

    The primary authors of this proposed rule are Drs. Keith A. 
Morehouse, U.S. Fish and Wildlife Service, and Barnett Rattner, 
Patuxent Environmental Science Center, National Biological Service, 
Laurel, Maryland.

List of Subjects in 50 CFR Part 20

    Exports, Hunting, Imports, Reporting and recordkeeping 
requirements, Transportation, Wildlife.

    Accordingly, Part 20, Subchapter B, Chapter I 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: Migratory Bird Treaty Act (July 3, 1918), as amended 
(16 U.S.C. 703-711); the Fish and Wildlife Improvement Act of 1978 
(November 8, 1978), as amended (16 U.S.C. 712); and the Fish and 
Wildlife Act of 1956 (August 8, 1956), as amended (16 U.S.C. 742 a-d 
and e-j).

    2. Section 20.134 is amended by revising paragraph (b) as set forth 
below and removing paragraph (c):


Sec. 20.134  Nontoxic shot.

* * * * *
    (b) Application and review. Tiered Strategy for Approval of 
Nontoxic Shot and Anti-corrosion Thin-Coating for Nontoxic Shot.
    (1) All applications for approval under these sections will be 
submitted with supporting documentation to the Director in accordance 
with the following procedures, and will include at a minimum the 
supporting materials and information covered by Tier 1 in the tiered 
approval system as follows:
    (2) Tier 1. (i) (A) Applicant provides statements of use, chemical 
characterization, production variability, volume of use of material 
requested to be approved and shot sample as listed in paragraphs 
(b)(2)(i)(A) (1) through (5) of this section. The candidate shot and/or 
coating may be chemically analyzed by the Service or an independent 
laboratory and the results will be compared to the applicant's 
descriptions of shot composition and composition variability. If the 
application is incomplete or if the composition of the candidate 
material, upon analysis, varies from that described by the applicant it 
will be rejected.
    (1) Statement of proposed use, i.e., purpose and types. 
    
[[Page 2474]]

    (2) Description of the chemical composition of the intact material.
    (i) Chemical names, Chemical Abstracts Service numbers, and 
structures.
    (ii) Chemical characterization for organics and organometallics for 
coating and core (e.g., empirical formula, melting point, molecular 
weight, solubility, specific gravity, partition coefficients, 
hydrolysis half-life, leaching rate (in water and soil) degradation 
half-life, vapor pressure, stability and other relevant 
characteristics).
    (iii) Composition and weight of shot material.
    (iv) Thickness, quantity (e.g., mg/shot), and chemical composition 
of coating per shot.
    (3) Statement of the expected variability of shot coating or shot 
during production.
    (4) Estimate of yearly volume of coated shot or shot used for 
hunting migratory birds in the U.S.
    (5) 25 pounds of the candidate shot and/or shot with coating, as 
applicable, in size equivalent to United States standard size No. 4 
(0.17 inches in diameter).
    (B) Applicant provides information on the toxicological effects of 
the shot coating and/or shot as follows:
    (1) A brief synopsis of the acute and chronic mammalian toxicity 
data of the shot coating and/or shot material ranking its toxicity 
(e.g., LD50<5 mg/kg = super-toxic, 5-50 mg/kg = extremely toxic, 50-500 
mg/kg = very toxic, 500-5,000 mg/kg = moderately toxic, 5,000-15,000 = 
slightly toxic, >15,000 mg/kg = practically nontoxic).
    (2) A summary of known toxicological data of the chemicals 
comprising the shot and/or shot coating material with respect to birds, 
particularly waterfowl (include LD50 or LC50 data, and sublethal 
effects).
    (3) A narrative description of the toxic effect of complete erosion 
and absorption of the shot and/or coating material in a 24-hour period. 
(Define the nature of toxic effect--e.g., mortality, impaired 
reproduction, substantial weight loss, disorientation and other 
relevant associated observations.)
    (4) A statement that there is or is not any basis for concern for 
shot or coated shot material ingestion by fish or mammals. If there is 
some recognized impact on mammals or fish, the Service may require 
additional study.
    (5) Summarize the toxicity data of the shot and/or shot coating 
material to aquatic and terrestrial invertebrates, amphibians and 
reptiles.
    (C) Applicant provides information on the environmental fate and 
transport, if any, of the shot and/or shot coating material as follows:
    (1) A statement that the shot coatings and/or shot is or is not 
chemically or physically altered upon firing. If so, the statement must 
describe any alterations.
    (2) An estimate of the environmental half-life of the shot and/or 
shot coating and a description of the chemical form of the breakdown 
products of the shot coating and/or shot.
    (3) Information on the Estimated Environmental Concentration (EEC) 
assuming 69,000 shot per hectare (Bellrose 1959) for:
    (i) A terrestrial ecosystem, assuming complete erosion of material 
in 5 cm of soil. What would be the EEC and does the EEC exceed existing 
clean soil standards? (Environmental Protection Agency [EPA] standards 
for the Use of Disposal of Sewage Sludge; 40 CFR Part 503). What is the 
estimated EEC and how does that relate to the toxicity threshold for 
plants, invertebrates, fish and wildlife?
    (ii) An aquatic ecosystem, assuming complete erosion of the shot 
coating and/or shot in 1 cubic foot of water. What is the estimated 
EEC, and how does it compare to the EPA Water Quality Criteria and 
toxicity thresholds in plants, invertebrates, fish and wildlife.
    (D) Fish and Wildlife Service evaluation of an application.
    (1) The Service will conduct a risk assessment using 1 LD50/square 
foot as the level of concern based on granular pesticides.
    (2) In cooperation with the applicant, the Service will conduct a 
risk assessment using the Quotient Method (Barnthouse et al. 1982): 
Risk = EEC/Toxicological Level of Concern Compare EEC in ppm to an 
effect level (e.g., LD50 in ppm). If Q < 0.1 = No Adverse Effects; If 
0.1  Q  10.0 = Possible Adverse Effects; If Q > 
10.0 = Probable Adverse Effects.
    (ii) Upon receipt of the Tier 1 application, the Director will 
review it to determine if the submission is complete. If complete, the 
applicant will be notified within 30 days of receipt that a thorough 
review of the application will commence. A Notice of Review will be 
published in the Federal Register announcing the initiation of review 
of a Tier 1 application. Review of a Tier 1 application will be 
concluded within 60 days of the date published in the Notice of Review.
    (iii) If after review of the Tier 1 test data materials the Service 
determines that the information does not conclusively establish that 
the shot and coating material do not impose a significant danger to 
migratory birds and other wildlife and their habitats or that 
significant data are incomplete, the applicant will be advised to 
proceed with the additional testing described in Tier 2. The public 
will be informed by a Notice of Review that Tier 1 test results are 
inconclusive and Tier 2 testing has been recommended.
    (iv) If review of the Tier 1 test data results in a preliminary 
determination that the candidate materials do not impose a significant 
danger to migratory birds and other wildlife and their habitats, the 
Director will publish in the Federal Register a proposed rule stating 
the Service's intention to approve this shot and/or coating. The 
rulemaking will include a description of the chemical composition of 
the candidate shot and/or coating and a synopsis of findings under the 
standards required for Tier 1. If, at the end of the comment period, 
the Service finds no technical or scientific basis upon which to deny 
approval, the candidate material will be approved by the publication of 
a final rule in the Federal Register. If as a result of the comment 
period, the Service determines that the information does not 
conclusively establish that the shot and/or coating material do not 
impose a significant danger to migratory birds and other wildlife and 
their habitats, Tier 2 testing will be recommended and a Notice of 
Review will be published in the Federal Register. If the applicant 
chooses not to proceed, the determination denying approval will be 
published in the Federal Register.
    (3) Tier 2, (i) Upon determination that Tier 1 information is 
inconclusive, the applicant will be notified by the Director to submit 
a Tier 2 testing plan for conducting further testing as outlined in 
paragraphs (b)(3)(ii), (A), (B) and (C) of this section. The Tier 2 
testing plan submitted by the applicant will be reviewed by the 
Director within 30 days of receipt. The Director may decline to approve 
the plan, or any part of it, if deficient in any manner with regard to 
timing, format or content. The Director shall apprise the applicant 
regarding what parts, if any, of the submitted testing procedures need 
not be conducted and any modifications that must be incorporated into 
the Tier 2 testing plan. The Director, or authorized representative, 
may elect to inspect laboratory facilities to be used. If the plan is 
accepted, Tier 2 testing will then be conducted, analyzed and reported 
by the applicant to the Director.
    (ii) The candidate shot and/or coating will first be run through a 
standardized test under in vitro conditions (see below) that will 
assess its erosion in an 

[[Page 2475]]
environment simulating in vivo conditions of a waterfowl gizzard, and 
any release of components into a liquid medium. Erosion characteristics 
will be compared to those of lead shot and steel shot of comparable 
size. Following the erosion rate testing, the candidate shot and/or 
coating will be subjected to a 30-day acute toxicity test and a test to 
determine its affects on selected fish and invertebrates.
    (A) Conduct a standardized in vitro test to determine erosion rate 
of the candidate shot and/or coating using the general guidelines as 
follows: Standardized Test for Erosion Rate. (Ref.: Kimball, W.H., and 
Z.A. Munir. 1971. The corrosion of lead shot in a simulated waterfowl 
gizzard. J. Wildl. Manage. 35(2):360-365.)
    (1) Typical Test Materials.

Atomic absorption spectrophotometer.
Drilled aluminum block to support test tubes.
Thermostatically controlled stirring hot plate.
Small teflon-coated magnets.
Hydrochloric acid (pH 2.0) and pepsin.
Capped test tubes.
Lead, steel and candidate shot (if appropriate).

    (2) Typical Test Procedures. Hydrochloric acid and pepsin are added 
to each capped test tube at a volume and concentration that will erode 
a single #4 lead shot at a rate of 5 mg/day. Three test tubes, each 
containing either lead shot, steel shot or candidate shot and/or 
coating, are placed in the aluminum block on the stirring hot plate. A 
teflon coated magnet is added to each test tube and the hot plate is 
set at 42 degrees centigrade and 500 revolutions per minute. Erosion of 
shot and/or coating will be determined on a daily basis for 14 
consecutive days by weighing the shot and analyzing the digestion 
solution with an atomic absorption spectrophotometer. The 14-day 
procedure will be replicated five times.
    (3) Typical Test Analyses. Erosion rates of the three types of shot 
will be compared by appropriate analysis of variance and regression 
procedures. The statistical analysis will determine whether the rate of 
erosion of the candidate shot and/or coating is significantly greater 
or less than that of lead and steel. This determination is important to 
any subsequent toxicity testing.
    (ii) Acute Toxicity Test--Tier 2 (Short-term, 30-day acute toxicity 
test using a commercially available duck food.). Over a 30-day period, 
conduct a short-term acute toxicity test that complies with the general 
guidelines described as follows:
    (1) Typical Test Materials.

48 male and 48 female hand-reared mallards approximately 6 to 8 
months old.
Mallards must have plumage and body conformation that resemble wild 
mallards.
96 outdoor pens equipped with food containers and water.
Laboratory equipped to perform fluoroscopy, required blood and 
tissue assays.
Commercial duck food.
Lead, steel and candidate shot.

    (2) Typical Test Procedures. Mallards will be housed individually 
in pens and given ad libitum access to food and water. After 3 weeks, 
they will be randomly assigned to 6 groups (8 males and 8 females/
group), dosed with 8 pellets of No. 4 lead, steel, or the candidate 
shot and/or coatings. Birds will be fluoroscoped 1 week after dosage to 
check for shot retention. Birds will be observed daily for signs of 
intoxication and mortality over a 30-day period. Body weight will be 
determined at the time of dosing, and at day 15 and 30 of the test. On 
days 15 and 30 blood will be collected by venipuncture for 
determination of hematocrit, hemoglobin concentration and other 
specified blood chemistries. All survivors will be sacrificed on day 
30. The liver and other appropriate organs will be removed from the 
sacrificed birds and from other birds dying prior to sacrifice on day 
30 for histopathological analysis. The organs will be analyzed for lead 
and compounds contained in the candidate shot and/or shot coatings. All 
birds will be necropsied to determine any pathological conditions.
    (3) Typical Test Analyses. Mortality among the specified groups 
will be analyzed with appropriate chi-square statistical procedures. 
Physiological data and tissue contaminant data will be analyzed by 
analysis of variance or other appropriate statistical procedures to 
include the factors of shot type and sex. Comparison between sacrificed 
birds and birds dying before sacrifice will be made whenever sample 
sizes are adequate for meaningful comparison. Procedures should be in 
compliance with the Good Laboratory Practices Standards (40 CFR Part 
160). The applicant will ensure that copies of all the raw data and 
statistical analyses accompany the laboratory reports and final 
comprehensive report of this test when they are sent to the Director.
    (C) Daphnid and Fish Early-Life Toxicity Tests. Determine the 
toxicity of the shot or shot coating (whole shot and eroded coating) to 
selected fish and invertebrates subject to the environmental effects 
test regulations developed under the authority of the Toxic Substances 
Control Act (15 U.S.C. 2601 et seq.), as follows:
    (1) The first test, the Daphnid Acute Toxicity Test (40 CFR Section 
797.1300), is a guideline for use in developing data on the acute 
toxicity of chemical substances. This guideline prescribes an acute 
toxicity test in which daphnids are exposed to a chemical in a static 
and flow-through system with the resulting data used by the agencies to 
assess the hazard that the chemical may present to an aquatic 
environment.

    (2) The second test is the Daphnid Chronic Toxicity Test (40 CFR 
Section 797.1330) and is used to develop data on the chronic toxicity 
of chemical substances in which daphnia are exposed to a chemical in a 
renewal or flow-through system. The data from this test are again used 
to assess the hazard that chemical may present to an aquatic 
environment.

    (3) A third test, Fish Early Life Stage Toxicity Test (40 CFR 
Section 797.1600), is required and is a test to assess the adverse 
effects of chemical substances to fish in the early stages of their 
growth and development. Data from this test are also used to determine 
the hazard a chemical may present to an aquatic environment.

    (iii) After the Tier 2 testing is concluded, the applicant will 
report the results to the Director. Submitted materials will include 
test results (data analysis reports, lab data) and a written final 
report. If after review of the Tier 2 test data the Service determines 
that the information does not conclusively establish that the shot and/
or coating material do not impose a significant danger to migratory 
birds and other wildlife and their habitats or that significant data 
are missing and/or incomplete, the applicant will be advised to proceed 
with the additional testing described in Tier 3. The public will be 
informed by a Notice of Review that Tier 2 test results are 
inconclusive and Tier 3 testing has been recommended.

    (iv) If review of the Tier 2 test data results in a preliminary 
determination that the candidate shot and/or coating materials do not 
impose a significant danger to migratory birds and other wildlife and 
their habitats, the Director will publish in the Federal Register a 
proposed rule stating the Service's intention to approve this shot and/
or coating. The rulemaking will include a description of chemical 
composition of the candidate shot and/or coating and a synopsis of 
findings under the standards required at Tier 2. If at the end of the 
comment period, the Service finds no technical or scientific basis upon 
which to deny approval, the candidate shot and/or coating material will 
be 

[[Page 2476]]
approved by publication of a final rule in the Federal Register. If, as 
a result of the comment period, the Service determines that the 
information does not conclusively establish that the shot and coating 
material do not impose a significant damage to migratory birds and 
other wildlife habitats, Tier 3 testing will be recommended and a 
Notice of Review will be published in the Federal Register. If the 
applicant chooses not to proceed, the determination denying approval 
will be published in the Federal Register denying approval of the 
candidate shot.
    (4) Tier 3.
    (i) Upon determination that the Tier 2 information is inconclusive, 
the applicant will be notified by the Director to submit a Tier 3 
testing plan for conducting further testing as outlined in paragraphs 
(b)(4)(i) (A) and (B) of this section. The Tier 3 testing plan 
submitted by the applicant will be reviewed by the Director within 30 
days of receipt. The Director may decline to approve the plan, or any 
part of it, if deficient in any manner with regard to timing, format or 
content. The Director shall apprise the applicant regarding what parts, 
if any, of the submitted testing procedure need not be conducted and 
any modifications that may be necessary to incorporate into the Tier 3 
plan. The Director, or authorized representative, may elect to inspect 
laboratory facilities to be used. If the plan is accepted, Tier 3 
testing will then be conducted, analyzed and reported by the applicant 
to the Director.
    (A) Chronic Toxicity Test--Tier 3 (Long-term, 8-9 week toxicity 
test under depressed temperature conditions using a nutritionally-
deficient diet.). Conduct a chronic exposure test under adverse 
conditions that complies with the general guidelines described as 
follows:
    (1) Typical Test Materials.

36 male and 36 female hand-reared mallards approximately 6 to 8 
months old. The mallards must have plumage and body conformation 
that resembles wild mallards.
72 elevated outdoor pens equipped with food containers and waterers.
Laboratory equipped to perform fluoroscopy, required blood and 
tissue assays, and necropsies.
Whole kernel corn.
Lead, steel, and candidate shot with or without coating, or coating, 
as applicable.

    (2) Typical Test Procedures. (i) This test will be conducted at a 
location where the mean monthly low temperature during December through 
March is between 20 and 40 degrees Fahrenheit (-6.6 and 4.4 degrees 
centigrade, respectively). Mallards will be individually assigned to 
elevated outdoor pens during the first week of December and acclimated 
to an ad libitum diet of whole kernel corn for 2 weeks. Birds will be 
randomly assigned to 5 groups (lead group of 4 males and 4 females, 4 
other groups of 8 males and 8 females/group). The lead group will be 
dosed with 1 size No. 4 pellet of lead. One group (8 males and 8 
females) will be dosed with 8 size No. 4 pellets of steel and the 3 
other groups (8 males and 8 females/group) will be dosed with 1, 4 and 
8 size No. 4 pellets of candidate shot and/or coating, respectively.
    (ii) Birds will be weighed and fluoroscoped weekly. All recovered 
shot will be weighed to measure erosion. Blood parameters given in the 
30-day acute toxicity test will again be determined in this procedure. 
Body weight and blood parameter measurements will be made on samples 
drawn at 24 hours after dosage and at the end of days 30 and 60. At the 
end of 60 days, all survivors will be sacrificed. The liver and other 
appropriate organs will be removed from the sacrificed birds and birds 
dying prior to sacrifice on day 60 for histopathological analysis. The 
organs will be analyzed for lead and other metals contained in the 
steel and candidate shot and/or coating. All birds dying prior to 
sacrifice will be necropsied to determine pathological conditions 
associated with death.
    (3) Typical Test Analyses. Mortality among the specified groups 
will be analyzed with appropriate chi-square statistical procedures. 
Any effects on the previously mentioned physiological parameters caused 
by the candidate shot and/or coating must be significantly less than 
those caused by lead shot and must not be significantly greater than 
those caused by steel shot. Physiological data and tissue contaminant 
data will be analyzed by analysis of variance or appropriate 
statistical procedures to include the factors of shot type, dose and 
sex. Comparisons between sacrificed birds and birds dying before 
sacrifice will be made whenever sample sizes are adequate for a 
meaningful comparison. Procedures should be in compliance with the Good 
Laboratory Practices Standards (40 CFR Part 160). The applicant will 
ensure that copies of all the raw data and statistical analyses 
accompany the lab analyses and final comprehensive reports of this test 
when they are sent to the Director.
    (B) Chronic Dosage Study--Tier 3 (Moderately long-term study that 
includes reproductive assessment.). Conduct chronic exposure 
reproduction trial with the general guidelines described as follows:
    (1) Typical Test Materials.

60 male and 60 female hand-reared first year mallards. These 
mallards must have plumage and body conformation that resemble wild 
mallards.
Pens suitable for quarantine and acclimation and for reasonably 
holding 5-10 ducks each.
60 elevated, pens equipped with feeders, waterers and nest boxes.
Laboratory equipped to perform fluoroscopy and required blood 
assays.
Corn and commercial duck breeder mash.
Steel and candidate shot and/or coating, as applicable.

    (2) Typical Test Procedures. (i) Mallards will be randomly assigned 
to 2 groups (30 males and 30 females/group) in December and held in 
same-sex groups until mid-January (dates apply to outdoor test facility 
only and will reflect where in the U.S. tests are conducted). After a 
3-week acclimation period, birds will be provided an ad libitum diet of 
corn for 60 days and are then paired (one pair/pen) and switched to 
commercial mash. Dosing of the 2 groups with 8 pellets of No. 4 steel 
(group 1) and candidate shot and/or coating (group 2) will occur after 
the acclimation period (day 0) and redosed after 30, 60, and 90 days.
    (ii) Birds will be fluoroscoped 1 week after dosage to check shot 
retention. Males and females will be weighed the day of initial dosing 
(day 0), at each subsequent dosing, and at death. Blood parameters 
identified in the 30-Day Acute Toxicity Test will again be measured in 
this test using samples drawn at time of weighing. The date of first 
egg will be noted as will the mean number of days per egg laid. Laying 
will be concluded after 21 normal, uncracked eggs are laid or after 150 
days, at which time the adults will be sacrificed. The liver and other 
appropriate organs will be removed from the sacrificed birds and from 
other birds dying prior to sacrifice for histopathological analysis. 
The organs and the 11th egg will be analyzed for compounds contained in 
the candidate shot or shot coatings. All birds will be necropsied to 
determine any pathological conditions. Nests will be checked daily to 
collect eggs. Any eggs laid before pairing will be discarded. Eggs will 
be artificially incubated and the percent shell-less, percent eggs 
cracked, percent fertility (as determined by candling), and percent 
hatch of fertile eggs will be calculated for each female. Ducklings 
will be provided with starter mash after hatching. All ducklings will 
be sacrificed when reaching 14 days of age. Survival to day 14 and 
weight of the ducklings at hatching and sacrifice will be measured. 
Blood parameters identified in the 30-Day Acute Toxicity Test will be 

[[Page 2477]]
measured using samples drawn when sacrificed.
    (3) Typical Test Analyses.
    Any mortality, reproductive inhibition or effects on the previously 
mentioned physiological parameters by the candidate shot and/or coating 
must not be significantly greater that those caused by steel shot. 
Percentage data will be subjected to an arcsine, square root 
transformation prior to statistical analyses. Physiological and 
reproductive data will be analyzed by one-tailed t-tests 
(=0.05), or other appropriate statistical procedures. 
Procedures should be in compliance with the Good Laboratory Practice 
Standards (40 CFR Part 160). The applicant will ensure that copies of 
all raw data and statistical analyses accompany the lab analyses and 
comprehensive reports of this test when they are sent to the Director.
    (ii) After the Tier 3 testing is concluded, the applicant will 
report the results to the Director. Submitted materials will include 
test results (data analysis reports, lab data) and a written final 
report. If after review of the Tier 3 test data (to be completed 60 
days after receipt of material) the Service determines that the 
information does not conclusively establish that the shot and/or 
coating material do not impose a significant danger to migratory birds 
and other wildlife and their habitats, or that significant data are 
incomplete, the applicant will be given the option of repeating the 
tests in Tier 3 that were deemed inconclusive. If the applicant chooses 
not to repeat the tests, approval of the candidate shot and/or coating 
will be denied. The public will be informed by a Notice of Review that 
Tier 3 test results are inconclusive and of the applicant's decision 
not to repeat Tier 3 testing. The publication will state that approval 
of candidate shot and/or coating is denied.
    (iii) If review of either the initial or repeated Tier 3 test data 
results in a preliminary determination that the candidate materials do 
not impose a significant danger to migratory birds and other wildlife 
and their habitats, the Director will publish in the Federal Register a 
proposed rule stating the Service's intention to approve this shot and/
or coating. The rulemaking will include a description of chemical 
composition of the candidate shot and/or coating and a synopsis of 
findings under the standards required by Tier 3. If at the end of the 
comment period, the Service finds no technical or scientific basis upon 
which to deny approval, the candidate shot and/or coating material will 
be approved by publication of a final rule in the Federal Register. If, 
as a result of the comment period the Service determines that the 
information does not conclusively establish that the shot and/or 
coating material do not impose a significant danger to migratory birds 
and other wildlife and their habitats, the applicant will be given an 
opportunity to answer the concerns expressed by the comments with 
additional testing. The decision to conduct additional testing will be 
published as a Notice of Review. If the applicant chooses not to 
proceed, the final determination denying approval will be published in 
the Federal Register.
    (iv)(A) The Tier 2 toxicity tests involving invertebrates and 
early-life stage vertebrates are intended to assess potential impacts 
on waterfowl habitat. The three toxicity tests with waterfowl described 
in Tiers 2 and 3 represent an evaluation of the three major categories 
of toxic effects: short-term periodic exposure; chronic exposure under 
adverse environmental conditions; and chronic exposure impact on 
reproduction. In the appropriate situations, the test animals will be 
exposed to the candidate material: both acutely and chronically; both 
stressed and non-stressed by diet and temperature; and with comparisons 
made to lead and steel shot regarding mortality and sublethal effects. 
The inclusion of lead shot and steel shot control groups in the 
waterfowl feeding studies is considered necessary for dealing with the 
experimental variability associated with tests being performed by 
different laboratories under a variety of conditions beyond control of 
the experimental protocol. Toxicity tests described in this rule are 
designed for testing the effects of metal or metalloid shot. The 
details of the experimental procedures can be modified, if necessary, 
to address the specific composition and erosion characteristics of the 
candidate shot. If the candidate shot is not metal or metalloid, other 
testing procedures will have to be developed and approved to evaluate 
the effects of the components of the candidate shot and/or coating 
materials.
    (B) Statistical analyses will be performed on all data from each 
test. For the purpose of this section (20.134) the terms significant 
and significantly refer to a (P0.05) finding of 
significance.

    Dated: October 25, 1995.
George T. Frampton, Jr.,
Assistant Secretary for Fish and Wildlife and Parks.
[FR Doc. 96-1179 Filed 1-25-96; 8:45 am]
BILLING CODE 4310-55-P