Migratory Bird Hunting: Revised Test Protocol for Nontoxic 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: Revised Test Protocol for Nontoxic

Approval Procedures for Shot and Shot Coatings

AGENCY: Fish and Wildlife Service, Interior.

ACTION: Final rule.

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SUMMARY: The purpose of this action is to revise the current nontoxic

shot approval procedures by establishing a tiered approval process.

Shot or shot coating approval is considered at each tier. An

environmentally benign shot or a minor modification of previously

approved shot may receive nontoxic approval after the first tier

contingent on existence of appropriate toxicological data and an

ecological risk assessment. If not, further testing would be required.

DATES: This final rule takes effect December 31, 1997.

ADDRESSES: Director (FWS/MBMO), U.S. Fish and Wildlife Service, 634

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

FOR FURTHER INFORMATION CONTACT: Paul Schmidt, Chief, or Carol

Anderson, Wildlife Biologist, Office of Migratory Bird Management, 703/

358-1714.

SUPPLEMENTARY INFORMATION: The U.S. Fish and Wildlife Service (Service)

is revising the existing nontoxic shot and shot coating approval

procedures (50 CFR 20.134) by establishing a three-tier approval

process. Shot or shot coating approval is considered at each tier. An

environmentally benign shot or a minor modification of previously

approved shot may receive nontoxic approval after the first tier

contingent upon the existence of appropriate toxicological data and an

ecological risk assessment. The Service has modified the existing

regulation because:

1. From an ecosystem management perspective, in addition to

waterfowl, we need to evaluate species such as invertebrates and fish

as these provide a food base for many waterfowl species;

2. Since the original regulations were in effect, advancements in

the field of ecological risk assessment can be applied to this process;

3. Reduction of time, expense and burden on the Federal Government

and applicants can occur without risk to wildlife; and

4. From an animal welfare standpoint, reduction in numbers of test

animals used can occur without risk to wildlife.

The original procedures were put in place in 1986 and the first

submission requesting approval of nontoxic shot came in October of

1993. Our experience with this shot approval process has shown that the

procedures need modification to accommodate situations where existing

information can minimize the need for full testing. Thus, the Service

and the U.S. Geological Survey--Biological Resources Division

cooperatively have developed an alternative set of procedures for

evaluating nontoxic shot and shot coatings to replace the testing

requirements presently in effect. As with the current procedures, the

new set of approval procedures carry the requirement that the applicant

carry the burden of providing that the candidate shot or shot coating

is nontoxic.

The system has three tiers, with each tier enhancing the

information base on the candidate material. Those candidate materials

where appropriate background information, toxicological data,

ecological risk assessment, and reproductive effects information are

available demonstrating the candidate material to be benign may receive

nontoxic approval. Those candidate materials not approved as a result

of subjecting them to the standards set at Tier 1 will be subject to

the standards of Tier 2, Tier 3, or both.

Tier 1 sets out comprehensive and detailed requirements that must

be provided to the Service in order to consider approval. After

evaluation of Tier 1 information, the Service will determine to grant

or deny approval, or require testing of Tier 2, Tier 3, or both.

The scope of Tier 1 includes: (1) Physical and chemical

characterization of candidate shot or shot coating; (2) information on

the toxicity of the candidate material; (3) an ecological risk

assessment; and (4) effects on reproduction in water birds of the

candidate material.

The scope of Tier 2 includes in vitro erosion rate testing, short-

term (30-day) acute toxicity testing on mallards, and toxicity tests

with invertebrates and early-life stage vertebrates to assess potential

impacts on waterfowl habitat. The inclusion of lead shot (positive) and

steel shot (negative) control groups in the waterfowl feeding studies

is necessary to account for the experimental variability associated

with: (1) Tests performed by different laboratories; (2) a series of

tests performed within a given laboratory; and/or (3) an individual

test, given changing conditions which are beyond control of the

experimental protocol. Further, although the positive control group is

essential to every shot ingestion study series, the Service has

considered the documented history of the results of lead shot ingestion

by waterfowl and reduced the numbers of birds required for that aspect

of the protocol.

The scope of Tier 3 includes chronic exposure under adverse

environmental conditions and effects on reproduction in mallards.

Modification of the experimental procedures to address the specific

composition and erosion characteristics of the candidate shot or shot

coating may be made by the Service, if necessary. If the candidate shot

or shot coating is not metal or metalloid, the Service, with the

applicant, may develop other equivalent testing procedures to evaluate

the effects of the components of the candidate shot and/or shot

coating.

Statistical analyses are to 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.

Other conditions of final approval include residual lead levels and

noninvasive field testing devices. The Service has established a

maximum environmentally acceptable level of lead in shot as trace

amounts of 15,000 mg/kg = practically nontoxic) with citations.

(2) A summary of known acute, chronic, and reproductive

toxicological data of the chemicals comprising the shot or shot coating

with respect to birds, particularly waterfowl (include LD50 or LC50

data, and sublethal effects) with citations.

(3) A narrative description, with citations to relevant data,

predicting the toxic effect in waterfowl of complete erosion and

absorption of one shot or coated shot in a 24-hour period. Define the

nature of toxic effect (e.g., mortality, impaired reproduction,

substantial weight loss, disorientation and other relevant associated

clinical observations).

(4) A statement, with supporting rationale and citations to

relevant data, that there is or is not any reasonable basis for concern

for shot or coated shot ingestion by fish, amphibians, reptiles or

mammals. If there is some recognized impact on fish, amphibians,

reptiles, or mammals, the Service may require additional study.

(5) Summarize the toxicity data of chemicals comprising the shot or

shot coating to aquatic and terrestrial invertebrates, fish,

amphibians, reptiles, and mammals.

(C) Applicant provides information on the environmental fate and

transport, if any, of the shot or shot coating as follows:

(1) A statement of the alteration of the shot or shot coating,

chemically or physically, upon firing. The statement must describe any

alterations.

(2) An estimate of the environmental half-life of the organic or

organometallic component of the shot or shot coating, and a description

of the chemical form of the breakdown products.

(3) Information on the Estimated Environmental Concentration (EEC)

assuming 69,000 shot per hectare (Bellrose 1959; Pain 1990) for:

(i) A terrestrial ecosystem, assuming complete dissolution of

material in 5 cm of soil. What would be the EEC and would that EEC

exceed existing clean soil standards? (Environmental Protection Agency

[EPA] standards for the Use of Disposal of Sewage Sludge; 40 CFR Part

503). How does the estimated EEC relate to the toxicity threshold for

plants, invertebrates, fish and wildlife?

(ii) An aquatic ecosystem, assuming complete dissolution of the

shot or shot coating 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) Service evaluation of an application.

(1) In reviewing the submission, the Service will use an exceedence

of 1 LD50/square foot as the level of concern (U.S.E.P.A. 1992) as a

criteria in the risk assessment.

(2) In cooperation with the applicant, the Service will conduct a

risk assessment using the Quotient Method (Environmental Protection

Agency 1986): 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.

(3) Upon receipt of the Tier 1 application, the Director will

review it to determine if the submission is complete. If complete, the

applicant is notified within 30 days of receipt that a thorough review

of the application will commence. A Notice of Application will appear

in the Federal Register announcing the initiation of review of a Tier 1

application. Complete review of a Tier 1 application will occur within

60 days of the date the Notice of Application is published in the

Federal Register.

(E) If, after review of the Tier 1 data, the Service does not

conclude that the shot or shot coating does not impose a significant

danger to migratory birds, other wildlife, and their habitats, the

applicant is advised to proceed with the additional testing described

for Tier 2, Tier 3, or both. A Notice of Review will inform the public

that Tier 1 test results are inconclusive, and Tier 2, Tier 3, or both

testing are required before further consideration.

(F) If review of the Tier 1 data results in a preliminary

determination that the candidate material does not impose a significant

danger to migratory birds, 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 or shot coating based on

the toxicological report and toxicity studies. The rulemaking will

include a description of the chemical composition of the candidate shot

or shot 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 alter its

conclusion, the candidate material will be approved by the publication

of a final rule in the Federal Register. If, after receiving public

comment, the Service determines that all available information does not

establish that the shot and/or shot coating does not impose a

significant danger to migratory birds, other wildlife, and their

habitats, Tier 2, Tier 3, or both testing will be required and a Notice

of Review will appear in the Federal Register. If only one of these two

Tier tests are required, the Service will explain in the notice why the

other is not required. If the applicant chooses not to proceed, the

determination denying approval will appear in the Federal Register.

(ii) Reserved.

(3) Tier 2.

(i) If Tier 2 testing is required, the applicant must submit a plan

that addresses paragraph (b)(3)(ii) requirements. The Director will

review the Tier 2 testing plan submitted by the applicant 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 to disregard and any

modifications to incorporate into the Tier 2 testing plan in order to

gain plan approval. All testing procedures will be in compliance with

the Good Laboratory Practices Standards (40 CFR part 160) except where

they conflict with the regulations in this section or with a provision

of an approved plan. The Director, or authorized representative, may

elect to inspect the applicant's laboratory facilities and may decline

to approve the plan and further consideration of the candidate shot if

the facility does not meet the Good Laboratory Practices Standards.

After the plan is accepted, Tier 2 testing will commence. Required

analyses and reports, in accordance with the regulations in this

section, must be sent to the Director. The applicant will ensure that

copies of all the raw data and statistical analyses accompany the

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laboratory reports and final comprehensive report of this test.

(ii) Evaluation of the candidate shot or shot coating will first be

in a standardized test under in vitro conditions (see paragraph

(b)(3)(ii)(A)) that will assess its erosion and any release of

components into a liquid medium in an environment simulating in vivo

conditions of a waterfowl gizzard. Erosion characteristics are to be

compared with those of lead shot and steel shot of comparable size.

Following the erosion rate testing, the applicant must conduct a 30-day

acute toxicity test in mallards, and a test to determine the candidate

shot and/or shot coating effects on selected invertebrates and fish and

include the results in the report for the Director.

(A) In Vitro Erosion Rate Test. Conduct a standardized in vitro

test to determine erosion rate of the candidate shot or shot coating

using the guidelines in Kimball and Munir (1971), unless otherwise

provided by the Service.

(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; and Lead, steel and candidate shot/coated

shot.

(2) Typical test procedures. Add hydrochloric acid and pepsin 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. Place three test

tubes, each containing either lead shot, steel shot or candidate shot

and/or coated shot, in an aluminum block on the stirring hot plate. Add

a Teflon coated magnet to each test tube and set the hot

plate at 42 degrees centigrade and 500 revolutions per minute.

Determine the erosion of shot or coated shot daily for 14 consecutive

days by weighing the shot and analyzing the digestion solution with an

atomic absorption spectrophotometer. Replicate the 14-day procedure

five times.

(3) Typical test analyses. Compare erosion rates of the three types

of shot by appropriate analysis of variance and regression procedures.

The statistical analysis will determine whether the rate of erosion of

the shot and/or shot coating is significantly greater or less than that

of lead and steel. This determination is important to any subsequent

toxicity testing.

(B) 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

guidelines described as follows or as otherwise provided by the

Service:

(1) Typical test materials: 30 male and 30 female hand-reared

mallards approximately 6 to 8 months old (mallards must have plumage

and body conformation that resemble wild mallards); 60 elevated outdoor

pens equipped with feeders and waterers; Laboratory equipped to perform

fluoroscopy, required blood and tissue assays, and necropsies;

Commercial duck maintenance mash; and Lead, steel and candidate shot.

(2) Typical test procedures. House mallards individually in pens

and give ad libitum access to food and water. After 3 weeks, randomly

assign to 3 groups (10 males and 10 females/group), dose with eight

pellets of either No. 4 lead shot (positive control), steel shot

(negative control), or the candidate shot or coated shot. Fluoroscope

birds at 1 week after dosage to check for shot retention. Observe birds

daily for signs of intoxication and mortality over a 30-day period.

Determine body weight at the time of dosing, and at days 15 and 30 of

the test. On days 15 and 30, collect blood by venipuncture, determine

hematocrit, hemoglobin concentration and other specified blood

chemistries. Sacrifice all survivors on day 30. Remove the liver and

other appropriate organs from the sacrificed birds and from birds that

died prior to sacrifice on day 30 for histopathological analysis.

Analyze the organs for lead and compounds contained in the candidate

shot or coated shot. Necropsy all birds to determine any pathological

conditions.

(3) Typical test analyses. Analyze mortality among the specified

groups with appropriate chi-square statistical procedures. Analyze

physiological data and tissue contaminant data by analysis of variance

or other appropriate statistical procedures to include the factors of

shot type and sex. Compare sacrificed birds and birds that died prior

to sacrifice whenever sample sizes are adequate for meaningful

comparison.

(C) Daphnid and Fish Early-Life Toxicity Tests. Determine the

toxicity of the compounds that comprise the shot or shot coating (at

conditions maximizing solubility without adversely affecting controls)

to selected invertebrates and fish. These methods are 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 (conducted in

accordance with 40 CFR 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 Daphnid exposure to a

chemical in static and flow-through systems, with the agencies

assessing the hazard the compound(s) may present to an aquatic

environment.

(2) The second test is the Daphnid Chronic Toxicity Test (conducted

in accordance with 40 CFR 797.1330). This gathers data on the chronic

toxicity of chemical substances in which Daphnids (Daphnia spp.) 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 the compound(s)

may present to an aquatic environment.

(3) A third test, Fish Early Life Stage Toxicity Test (conducted in

accordance with 40 CFR Section 797.1600), assesses the adverse effects

of chemical substances to fish in the early stages of their growth and

development. Data from this test are used to determine the hazard the

compound(s) may present to an aquatic environment.

(iii) After the Tier 2 testing, the applicant will report the

results to the Director. If, after review of the Tier 2 data, the

Service determines that the information does not establish that the

shot or shot coating does not impose a significant danger to migratory

birds, other wildlife, and their habitats, the applicant is advised to

proceed with the additional testing in Tier 3. A Notice of Review

advises the public that, in conjunction with Tier 1 data, Tier 2 test

results are inconclusive and Tier 3 testing is required for continued

consideration.

(iv) If review of the Tier 2 test data results in a preliminary

determination that the candidate shot or shot coating does not impose a

significant danger to migratory birds, 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 and why Tier 3 testing is unnecessary. The rulemaking will

include a description of chemical composition of the shot or shot

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 or shot coating approval is published as a final rule in

the Federal Register. If, as a result of the comment period, the

Service determines that the information does not establish that the

shot and/or shot coating does not impose a significant danger to

migratory birds, other wildlife, and their habitats, Tier 3 testing

will be required and a Notice of Review published in the

[[Page 63614]]

Federal Register. If the applicant chooses not to proceed, the

determination denying approval of the candidate shot or shot coating

will appear in the Federal Register.

(4) Tier 3.

(i) If the Director determines that the Tier 1 or Tier 2

information is inconclusive, the Director will notify the applicant to

submit a Tier 3 testing plan for conducting further testing as outlined

in paragraphs (b)(4)(i) (A) and (B) of this section. Review, by the

Director, of the Tier 3 testing plan submitted by the applicant will

occur 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 to

disregard and any modifications to incorporate into the Tier 3 plan in

order to gain plan approval. All testing procedures should be in

compliance with the Good Laboratory Practices Standards (40 CFR part

160), except where they conflict with the regulations in this section

or with a provision of an approved plan. The Director, or authorized

representative, may elect to inspect the applicant's laboratory

facilities and may decline to approve the plan and further

consideration of the candidate shot and/or shot coating if the facility

is not in compliance with the Good Laboratory Practices Standards.

After acceptance of the plan, Tier 3 testing will commence. Required

analyses and reports must be sent to the Director. 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.

(A) Chronic Toxicity Test--Tier 3 (Long-term 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 unless otherwise

provided by the Service:

(1) Typical test materials: 36 male and 36 female hand-reared

mallards approximately 6 to 8 months old (Mallards must have plumage

and body conformation that resembles wild mallards); 72 elevated

outdoor pens equipped with feeders and waterers; Laboratory equipped to

perform fluoroscopy, required blood and tissue assays, and necropsies;

Whole kernel corn; and Lead, steel, and candidate shot or coated shot.

(2) Typical test procedures.

(i) Conduct this test 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). Assign

individual mallards to elevated outdoor pens during the first week of

December and acclimate to an ad libitum diet of whole kernel corn for 2

weeks. Randomly assign birds to 5 groups (lead group of 4 males and 4

females, 4 other groups of 8 males and 8 females/group). Dose the lead

group (positive control) with one size No. 4 pellet of lead shot. Dose

one group (8 males and 8 females) with eight size No. 4 pellets of

steel shot (negative control) and dose the 3 other groups (8 males and

8 females/group) with one, four and eight size No. 4 pellets of

candidate shot or coated shot.

(ii) Weigh and fluoroscope birds weekly. Weigh all recovered shot

to measure erosion. Determine blood parameters given in the 30-day

acute toxicity test. Provide body weight and blood parameter

measurements on samples drawn at 24 hours after dosage and at the end

of days 30 and 60. At the end of 60 days, sacrifice all survivors.

Remove the liver and other appropriate organs from sacrificed birds and

birds dying prior to sacrifice on day 60 for histopathological

analysis. Analyze organs for lead and other metals potentially

contained in the candidate shot or shot coating. Necropsy all birds

that died prior to sacrifice to determine pathological conditions

associated with death.

(3) Typical test analyses. Analyze mortality among the specified

groups with appropriate chi-square statistical procedures. Any effects

on the previously mentioned physiological parameters caused by the shot

or shot coating must be significantly less than those caused by lead

shot and must not be significantly greater than those caused by steel

shot. Analyze physiological data and tissue contaminant data by

analysis of variance or appropriate statistical procedures to include

the factors of shot type, dose and sex. Compare sacrificed birds and

birds that died prior to sacrifice whenever sample sizes are adequate

for a meaningful comparison.

(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

unless otherwise provided by the Service:

(1) Typical test materials: 44 male and 44 female hand-reared first

year mallards (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; 44 elevated, pens equipped

with feeders, waterers and nest boxes; Laboratory equipped to perform

fluoroscopy, required blood and tissue assays, and necropsies; Whole

kernel corn, and commercial duck maintenance and breeder mash; and

Lead, steel and candidate shot or coated shot.

(2) Typical test procedures. (i) Randomly assign mallards to 3

groups (Lead group = 4 males and 4 females; steel group = 20 males and

20 females; candidate shot/coated shot group = 20 males and 20 females)

in December and hold 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). Tests conducted in the southern U.S. will need to be

completed in low temperature units. After a 3-week acclimation period

with ducks receiving commercial maintenance mash, provide birds with an

ad libitum diet of corn for 60 days and then pair birds (one pair/pen)

and provide commercial breeder mash. Dosing of the 3 groups with one

pellet of No. 4 lead shot (positive control); eight pellets of No. 4

steel shot (negative control); and eight pellets of No. 4 candidate

shot or coated shot will occur after the acclimation period (day 0) and

redosed after 30, 60, and 90 days. Few, if any, of the lead-dosed birds

(positive control) should survive and reproduce.

(ii) Fluoroscope birds 1 week after dosage to check for shot

retention. Weigh males and females the day of initial dosing (day 0),

at each subsequent dosing, and at death. Measure blood parameters

identified in the 30-Day Acute Toxicity Test in this test using samples

drawn at time of weighing. Note the date of first egg and the mean

number of days per egg laid. Conclude laying after 21 normal, uncracked

eggs are laid or after 150 days. Sacrifice adults after completion of

laying period. Remove the liver and other appropriate organs from

sacrificed birds and from other birds that died prior to sacrifice for

histopathological analysis. Analyze organs and the 11th egg for

compounds contained in the shot or shot coating. Necropsy all birds to

determine any pathological conditions. Check nests daily to collect

eggs. Discard any eggs laid before pairing. Artificially incubate eggs

and calculate the percent shell thickness, percent eggs cracked,

percent fertility (as determined by candling), and percent hatch of

fertile eggs for each female. Provide ducklings with starter mash after

hatching. Sacrifice all ducklings at 14 days of age. Measure survival

to day 14 and weight of the

[[Page 63615]]

ducklings at hatching and sacrifice. Measure blood parameters

identified in the 30-Day Acute Toxicity Test using samples drawn at

sacrificing.

(3) Typical test analyses.

(i) Any mortality, reproductive inhibition or effects on the

physiological parameters in paragraph (b)(4) by the shot or shot

coating must not be significantly greater than those caused by steel

shot. Percentage data is subject to an arcsine, square root

transformation prior to statistical analyses. Physiological and

reproductive data is analyzed by one-tailed t-tests (=0.05),

or other appropriate statistical procedures by the applicant.

(ii) After conclusion of Tier 3 testing, the applicant must report

the results to the Director. If after review of the Tier 3 data

(completion 60 days after receipt of material) the Service determines

that all of the information gathered and submitted in accordance with

Tiers 1, 2, and 3, as applicable, does not establish that the shot or

shot coating does not impose a significant danger to migratory birds,

other wildlife, and their habitats, the applicant will have the option

of repeating the tests that the Director deems are inconclusive. If the

applicant chooses not to repeat the tests, approval of the candidate

shot or shot coating is denied. A Notice of Review will inform the

public that Tier 3 results are inconclusive, the applicant's decision

not to repeat Tier 3 testing, and the Service's subsequent denial of

the shot or shot coating.

(iii) If review of either the initial or repeated Tier 3 test data

results in a preliminary determination that the shot or shot coating

does not impose a significant danger to migratory birds, 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 or

shot coating and providing the public with the opportunity to comment.

The rulemaking will include a description of the chemical composition

of the shot or shot coating and a synopsis of findings under the

standards required by Tier 3. If at the end of the comment period, the

Service concludes that the shot or shot coating does not impose a

significant danger to migratory birds, other wildlife, or their

habitats, the shot or shot coating will be approved as nontoxic with

publication of a final rule in the Federal Register.

(5) Residual lead levels. The Service's maximum environmentally

acceptable level of lead in shot is trace amounts or <1 percent. Any

shot manufactured with lead levels equal to or exceeding 1 percent are

considered toxic and, therefore, illegal.

(6) Field Detection Device. Before approval of any shot for use in

migratory game bird hunting, a noninvasive field testing device must be

available for enforcement officers to determine the shot material in a

given shell in the field.

Dated: November 3, 1997.

Donald J. Barry,

Acting Assistant Secretary for Fish and Wildlife and Parks.

[FR Doc. 97-31328 Filed 11-28-97; 8:45 am]

BILLING CODE 4310-55-P