63608 Federal Register / Vol. 62, No. 230 / Monday, December 1, 1997 / Rules and Regulations

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.

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 (P≤0.05) 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 <1 percent

(August 15, 1995, 61 FR 42492). Any

shot manufactured with lead levels

equal to or exceeding 1 percent are toxic

and therefore, illegal. Further, the

Service has established approval

contingent upon the availability of a

noninvasive field testing device (August

15, 1996, 61 FR 42492) to determine

shot material in the shell in the field.

A schematic representation of the

approval process follows:

BILLING CODE 4310–55–P
Federal Register / Vol. 62, No. 230 / Monday, December 1, 1997 / Rules and Regulations 63609

BILLING CODE 4310–55–C
63610 Federal Register / Vol. 62, No. 230 / Monday, December 1, 1997 / Rules and Regulations

The intent of the shot and shot

coating approval procedure is to ensure

that, in addition to waterfowl, other

natural resources will be protected.

Furthermore, materials that

toxicologically are innocuous will

complete the procedures at lower cost

and with less paperwork for both the

Service and the applicant.

In summary, the purpose of this rule

is to revise the current shot approval

procedures and to include shot coatings.

Public Comment and Responses

The January 26, 1996, proposed rule

published in the Federal Register (61

FR 2470) invited comments from

interested parties. The closing date for

receipt of all comments was May 10,

1996. During this 115-day comment

period, the Service received five

comment letters. A brief summary of

those comments and the Service’s

response follows:

The National Institute of

Environmental Health Sciences limited

their comments to the toxicity testing

(clinical observation, tissue analysis,

and histopathology) of bismuth only,

and as such, are not incorporated into

the overall testing protocol.

The Missouri Department of

Conservation asked if coatings of

copper, nickel, and zinc on steel shot,

which already are approved, will have

‘‘grandfathered’’ approval. Yes, they

will. In December of 1986, based on a

review and evaluation of information in

an environmental assessment, the

Director issued a Finding Of No

Significant Impact and chose to approve

the use of copper or nickel coating on

steel shot. In May of 1993, based on

information from the National

Biological Survey (now the Biological

Resources Division of the U.S.G.S.), the

Service, and manufacturers, the Service

issued an approval for zinc chloride

and/or zinc chromed coating. These

coatings will retain the Service’s

approval. However, the Service may

reconsider both approvals at some

future date if it is determined that the

coatings may be creating toxicological

problems for migratory birds.

The Wisconsin Department of Natural

Resources requested deletion of ‘‘the

requirement for assessing toxicity after

complete absorption [because] we

suspect that most substances that would

pass all of the other tests would fail this

test.’’ This is a worst-case scenario

assumed in the risk assessment, and not

an actual toxicity test that the applicant

must complete. To ensure that

waterfowl will be protected, this

analysis must be completed.

The National Wildlife Federation

expressed concern that the Service’s

proposal to ‘‘scale back the testing

procedures’’ will increase the potential

for environmental harm. The Service’s

decision to revise the present testing

protocol is based on scientific

advancements in risk assessment,

toxicity testing, and modeling. In

actuality, the new test protocol is far

more demanding and scientifically

rigorous than the current three phase

nontoxic shot approval process because

it approaches the issue from an

ecosystem management perspective

incorporating recent advancements in

science. The new test protocol will

increase protection of the environment

by incorporating an ecosystem approach

and multi-species testing rather than

just a single species test with mallards.

The NWF also commented that ‘‘the

USFWS argues that from an animal

welfare standpoint, the numbers of test

animals used can be reduced. In fact, it

can be said that granting approval for a

shot compound which has not been

throughly tested makes the whole of the

wild waterfowl population test

animals.’’ Under the current testing

procedures, the entire ecosystem is the

test subject because it ignores every

environmental and biological

component other than waterfowl. The

Service is striving for a balanced

ecosystem approach to testing without

being overly burdensome. Instead of

using large numbers of one species, the

Service is incorporating the test with

several different species. The NWF also

stated that, ‘‘there are numerous cases

(e.g., the pesticide DDT) in which the

harmful effects of a product became

apparent only after loss of reproductive

viability of wildlife became chronic, by

which time the environmentally

harmful substance was widely dispersed

throughout the ecosystem.’’

Reproductive test data is an integral part

of the new test protocol. We recognize

the importance of reproductive testing,

and its importance in determining the

safety of a product. A reproductive

assessment with no adverse or

inconclusive results is required for final

approval of a candidate material as

nontoxic. ‘‘We [NWF] remain firmly

opposed to granting full or final

approval without completion of all three

phases of testing. At a minimum,

conditional approval should be granted

only after the currently mandated phase

one testing is complete.’’ Granting of

final approval will occur only when an

applicant sufficiently has satisfied Tier

1 and shown the candidate material to

be nontoxic. If Tier 1 testing results are

inconclusive, completion of Tier 2, Tier

3, or both will be required showing the

candidate material to be nontoxic. This

does not mean that completion of each

tier by each applicant is always

necessary. For example, if toxicity or

reproductive data on the candidate

material and mallards already exists, it

may be incorporated into the Tier 1

package and may be sufficient to

determine that the shot and/or shot

coating should be approved.

Safety Shot General Partner, Inc.

reiterates their original concerns from

their August 27, 1991, letter on the

proposed protocol. Safety Shot states

that ‘‘the proposed rule appears to

address our concerns about timing

issues and unreasonable testing.’’

NEPA Consideration

In compliance with 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 prepared

an Environmental Assessment (EA) in

November, 1996. This EA is available to

the public at the Office of Migratory

Bird Management, U.S. Fish and

Wildlife Service, ms 634-ARLSQ, 1849

C Street NW., Washington D.C. 20240.

Based on review and evaluation of the

information in the EA, the Service

determined the action to amend 50 CFR

20.134 would not be a major Federal

action that significantly would affect the

quality of the human environment.

Endangered Species Act Considerations

Section 7 of the Endangered Species

Act (ESA) of 1972, as amended (16

U.S.C. 1531 et seq.), provides that, ‘‘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 * * *’’ The Service

completed a Section 7 consultation

under the ESA for this rule. The

conclusion of that consultation is that

the long-term effect of the rule would be

beneficial, and that the rule itself is not

likely to adversely affect listed species.

However, as the nature of substances to

be reviewed is not known at this time,

each application will be reviewed for

potential effects to listed species. The

result of the Service’s consultation

under Section 7 of the ESA is available

to the public through the Office of

Migratory Bird Management, U.S. Fish

and Wildlife Service, ms 634 ARLSQ,

1849 C Street NW., Washington D.C.

20240.
Federal Register / Vol. 62, No. 230 / Monday, December 1, 1997 / Rules and Regulations 63611

Regulatory Flexibility Act, Executive

Order 12866, and the Paperwork

Reduction Act

The Regulatory Flexibility Act of 1980

(5 U.S.C. 601 et seq.) requires the

preparation of flexibility analyses for

rules that will have a significant effect

on a substantial number of small

entities, which includes small

businesses, organizations or

governmental jurisdictions. Since this is

a revision to existing procedures

designed to reduce cost and time

requirements in determining the toxicity

of a candidate material, 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. The

information collection requirements

contained within this part have been

approved by the Office of Management

and Budget (OMB) under 44 U.S.C. 3507

and assigned Clearance Number 1018–

0067 which expires on 06/30/2000. The

information must be provided in order

to obtain the benefit of being approved

as nontoxic shot. This information is

being collected to evaluate an

applicant’s candidate material.

The likely respondents to this

collection of information will be

companies producing and/or marketing

shot and/or shot coatings who wish to

obtain approval of the candidate shot as

nontoxic for use in hunting waterfowl

and coots. In order to make this

decision, the Service requires that

applicants submit information collected

about the toxicity of their candidate

material to migratory birds and the

environment. This data provides the

bulk of the application. The information

from scientific literature, risk

assessment analysis, and toxicity

studies, will be gathered and packaged

by the applicant. The Service expects to

receive one request each year. The

annual burden of reporting and record

keeping is estimated to be about 3,200

hours.

The principal economic effect of this

rule will be to allow sport hunting

retailers sales of more nontoxic shot

types. This will provide some additional

sales, however these sales are within a

niche market and not likely to dislocate

any other products. It is thought that

these sales may slightly reduce some of

the lead shot sales. The overall effect to

hunting expenditures in general will be

minor. This rule will accommodate

situations where existing information

can minimize the need for full testing

thereby reducing the time, expense, and

burden on the Federal Government and

applicant without risk to wildlife.

Therefore, this rulemaking was not

subject to review by the Office of

Management and Budget under

Executive Order 12866.

The potential applicants are likely to

be small entities, therefore, the

economic effects as described in

Executive Order 12866 are the same or

similar to the economic impacts of

annual hunting on small business

entities. The economic impacts of

annual hunting on small business

entities were analyzed in detail and a

Small Entity Flexibility Analysis

(Analysis), under the Regulatory

Flexibility Act (5 U.S.C. 601 et seq.),

was issued by the Service in 1995

(copies available upon request from

Office of Migratory Bird Management).

The Analysis documented the

significant beneficial economic effect on

a substantial number of small entities.

The primary source of information

about hunter expenditures for migratory

game bird hunting is the National

Hunting and Fishing Survey, which is

conducted at 5-year intervals. The

Analysis utilized the 1991 National

Hunting and Fishing Survey and the

U.S. Department of Commerce’s County

Business Patterns from which it was

estimated that migratory bird hunters

would spend between $10 and $59

million at small businesses in 1995. The

approval of other nontoxic alternative

shot to steel will have a minor positive

impact on small businesses by allowing

them to sell an additional nontoxic shot

to the hunting public. However, the

overall effect to hunting expenditures in

general would be minor.

Unfunded Mandates Reform

The Service has determined and

certifies pursuant to the Unfunded

Mandates Act, 2 U.S.C. 1502 et seq., that

this rulemaking will not impose a cost

of $100 million or more in any given

year on local or State government or

private entities.

Civil Justice Reform—Executive Order

12988

The Service, in promulgating this

rule, has determined that these

regulations meet the applicable

standards provided in Sections 3(a) and

3(b)(2) of Executive Order 12988.

Authorship

The primary authors of this rule are

Cynthia M. Perry and Keith A.

Morehouse, U.S. Fish and Wildlife

Service, and Barnett Rattner, Biological

Research Division of the U.S. Geological

Survey.

List of Subjects in 50 CFR Part 20

Exports, Hunting, Imports, Reporting

and recordkeeping requirements,

Transportation, Wildlife.

Accordingly, the Service amends part

20, Subchapter B, Chapter I of Title 50

of the Code of Federal Regulations as

follows:

PART 20—[AMENDED]

1. The authority citation for part 20

continues to read as follows:

Authority: 16 U.S.C. 703–712; and 16

U.S.C. 742 a–j.

2. Amend § 20.134 by revising

paragraph (b) as set forth below and

removing paragraph (c):

§ 20.134 Nontoxic shot.

* * * * *

(b) Application and review. Tiered

Strategy for Approval of Nontoxic Shot

and Shot Coating. (1) All applications

for approval under this section must be

submitted with supporting

documentation to the Director in

accordance with the following

procedures and must 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 candidate material and

shot sample as listed in paragraphs

(b)(2)(i)(A)(1) through (5), (b)(2)(i)(B)(1)

through (5), and (b)(2)(i)(C)(1) through

(3) of this section. The candidate shot or

shot coating may be chemically

analyzed by the Service or an

independent laboratory to compare the

results with the applicant’s descriptions

of shot composition and composition

variability. Rejection of the application

will occur if it is incomplete or if the

composition of the candidate material,

upon analysis, varies significantly from

that described by the applicant.

(1) Statement of proposed use, i.e.,

purpose and types.

(2) Description of the chemical

composition of the intact material.

(i) Chemical names, Chemical

Abstracts Service numbers (if available),

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.
63612 Federal Register / Vol. 62, No. 230 / Monday, December 1, 1997 / Rules and Regulations

(iv) Thickness, quantity (e.g., mg/

shot), and chemical composition of shot

coating.

(3) Statement of the expected

variability of shot during production.

(4) Estimate of yearly volume of

candidate shot and/or coated shot

expected for use in hunting migratory

birds in the U.S.

(5) Five pounds of the candidate shot

and/or coated shot, as applicable, in size

equivalent to United States standard

size No. 4 (0.13 inches in diameter).

(B) Applicant provides information on

the toxicological effects of the shot or

shot coating as follows:

(1) A summary of the acute and

chronic mammalian toxicity data of the

shot or shot coating 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) 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 < 0.1

= No Adverse Effects; If 0.1 ≤ 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
Federal Register / Vol. 62, No. 230 / Monday, December 1, 1997 / Rules and Regulations 63613

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 ι4

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
63614 Federal Register / Vol. 62, No. 230 / Monday, December 1, 1997 / Rules and Regulations

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 midJanuary (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
Federal Register / Vol. 62, No. 230 / Monday, December 1, 1997 / Rules and Regulations 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 (α=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