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

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

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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., LD5015,000 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 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