2470 Federal Register / Vol. 61, No. 18 / Friday, January 26, 1996 / Proposed Rules

3800, 2100 M Street, NW., Suite 140,

Washington, DC 20037.

Provisions of the Regulatory

Flexibility Act of 1980 do not apply to

this proceeding.

Members of the public should note

that from the time a Notice of Proposed

Rule Making is issued until the matter

is no longer subject to Commission

consideration or court review, all ex

parte contacts are prohibited in

Commission proceedings, such as this

one, which involve channel allotments.

See 47 CFR 1.1204(b) for rules

governing permissible ex parte contacts.

For information regarding proper

filing procedures for comments, see 47

CFR 1.415 and 1.420.

List of Subjects in 47 CFR Part 73

Radio broadcasting.

Federal Communications Commission.

John A. Karousos,

Chief, Allocations Branch, Policy and Rules

Division, Mass Media Bureau.

[FR Doc. 96–1421 Filed 1–25–96; 8:45 am]

BILLING CODE 6712–01–F

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.

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 § 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
Federal Register / Vol. 61, No. 18 / Friday, January 26, 1996 / Proposed Rules 2471

invertebrates, although it may not

require in vivo testing, per se.

Applicants would be required to

provide the Service with all the required

information at the time of application or

processing would be delayed. The

information provided by the applicant

will allow the Service, or others, to

conduct an independent analysis and to

make an informed decision on approval.

A schematic representation of the

approval process is provided here to aid

the reader:

BILLING CODE 4310–55–P
2472 Federal Register / Vol. 61, No. 18 / Friday, January 26, 1996 / Proposed Rules

BILLING CODE 4310–55–C
Federal Register / Vol. 61, No. 18 / Friday, January 26, 1996 / Proposed Rules 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 tenthousandths 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):

§ 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.
2474 Federal Register / Vol. 61, No. 18 / Friday, January 26, 1996 / Proposed Rules

(2) Description of the chemical

composition of the intact material.

(i) Chemical names, Chemical

Abstracts Service numbers, and

structures.

(ii) Chemical characterization for

organics and organometallics for coating

and core (e.g., empirical formula,

melting point, molecular weight,

solubility, specific gravity, partition

coefficients, hydrolysis half-life,

leaching rate (in water and soil)

degradation half-life, vapor pressure,

stability and other relevant

characteristics).

(iii) Composition and weight of shot

material.

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

shot), and chemical composition of

coating per shot.

(3) Statement of the expected

variability of shot coating or shot during

production.

(4) Estimate of yearly volume of

coated shot or shot used for hunting

migratory birds in the U.S.

(5) 25 pounds of the candidate shot

and/or shot with coating, as applicable,

in size equivalent to United States

standard size No. 4 (0.17 inches in

diameter).

(B) Applicant provides information on

the toxicological effects of the shot

coating and/or shot as follows:

(1) A brief synopsis of the acute and

chronic mammalian toxicity data of the

shot coating and/or shot material

ranking its toxicity (e.g., LD50<5 mg/kg

= super-toxic, 5–50 mg/kg = extremely

toxic, 50–500 mg/kg = very toxic, 500–

5,000 mg/kg = moderately toxic, 5,000–

15,000 = slightly toxic, >15,000 mg/kg =

practically nontoxic).

(2) A summary of known toxicological

data of the chemicals comprising the

shot and/or shot coating material with

respect to birds, particularly waterfowl

(include LD50 or LC50 data, and

sublethal effects).

(3) A narrative description of the toxic

effect of complete erosion and

absorption of the shot and/or coating

material in a 24-hour period. (Define the

nature of toxic effect—e.g., mortality,

impaired reproduction, substantial

weight loss, disorientation and other

relevant associated observations.)

(4) A statement that there is or is not

any basis for concern for shot or coated

shot material ingestion by fish or

mammals. If there is some recognized

impact on mammals or fish, the Service

may require additional study.

(5) Summarize the toxicity data of the

shot and/or shot coating material to

aquatic and terrestrial invertebrates,

amphibians and reptiles.

(C) Applicant provides information on

the environmental fate and transport, if

any, of the shot and/or shot coating

material as follows:

(1) A statement that the shot coatings

and/or shot is or is not chemically or

physically altered upon firing. If so, the

statement must describe any alterations.

(2) An estimate of the environmental

half-life of the shot and/or shot coating

and a description of the chemical form

of the breakdown products of the shot

coating and/or shot.

(3) Information on the Estimated

Environmental Concentration (EEC)

assuming 69,000 shot per hectare

(Bellrose 1959) for:

(i) A terrestrial ecosystem, assuming

complete erosion of material in 5 cm of

soil. What would be the EEC and does

the EEC exceed existing clean soil

standards? (Environmental Protection

Agency [EPA] standards for the Use of

Disposal of Sewage Sludge; 40 CFR Part

503). What is the estimated EEC and

how does that relate to the toxicity

threshold for plants, invertebrates, fish

and wildlife?

(ii) An aquatic ecosystem, assuming

complete erosion of the shot coating

and/or shot in 1 cubic foot of water.

What is the estimated EEC, and how

does it compare to the EPA Water

Quality Criteria and toxicity thresholds

in plants, invertebrates, fish and

wildlife.

(D) Fish and Wildlife Service

evaluation of an application.

(1) The Service will conduct a risk

assessment using 1 LD50/square foot as

the level of concern based on granular

pesticides.

(2) In cooperation with the applicant,

the Service will conduct a risk

assessment using the Quotient Method

(Barnthouse et al. 1982): Risk = EEC/

Toxicological Level of Concern Compare

EEC in ppm to an effect level (e.g., LD50

in ppm). If Q < 0.1 = No Adverse Effects;

If 0.1 ≤ Q ≤ 10.0 = Possible Adverse

Effects; If Q > 10.0 = Probable Adverse

Effects.

(ii) Upon receipt of the Tier 1

application, the Director will review it

to determine if the submission is

complete. If complete, the applicant will

be notified within 30 days of receipt

that a thorough review of the

application will commence. A Notice of

Review will be published in the Federal

Register announcing the initiation of

review of a Tier 1 application. Review

of a Tier 1 application will be

concluded within 60 days of the date

published in the Notice of Review.

(iii) If after review of the Tier 1 test

data materials the Service determines

that the information does not

conclusively establish that the shot and

coating material do not impose a

significant danger to migratory birds

and other wildlife and their habitats or

that significant data are incomplete, the

applicant will be advised to proceed

with the additional testing described in

Tier 2. The public will be informed by

a Notice of Review that Tier 1 test

results are inconclusive and Tier 2

testing has been recommended.

(iv) If review of the Tier 1 test data

results in a preliminary determination

that the candidate materials do not

impose a significant danger to migratory

birds and other wildlife and their

habitats, the Director will publish in the

Federal Register a proposed rule stating

the Service’s intention to approve this

shot and/or coating. The rulemaking

will include a description of the

chemical composition of the candidate

shot and/or coating and a synopsis of

findings under the standards required

for Tier 1. If, at the end of the comment

period, the Service finds no technical or

scientific basis upon which to deny

approval, the candidate material will be

approved by the publication of a final

rule in the Federal Register. If as a

result of the comment period, the

Service determines that the information

does not conclusively establish that the

shot and/or coating material do not

impose a significant danger to migratory

birds and other wildlife and their

habitats, Tier 2 testing will be

recommended and a Notice of Review

will be published in the Federal

Register. If the applicant chooses not to

proceed, the determination denying

approval will be published in the

Federal Register.

(3) Tier 2, (i) Upon determination that

Tier 1 information is inconclusive, the

applicant will be notified by the

Director to submit a Tier 2 testing plan

for conducting further testing as

outlined in paragraphs (b)(3)(ii), (A), (B)

and (C) of this section. The Tier 2

testing plan submitted by the applicant

will be reviewed by the Director within

30 days of receipt. The Director may

decline to approve the plan, or any part

of it, if deficient in any manner with

regard to timing, format or content. The

Director shall apprise the applicant

regarding what parts, if any, of the

submitted testing procedures need not

be conducted and any modifications

that must be incorporated into the Tier

2 testing plan. The Director, or

authorized representative, may elect to

inspect laboratory facilities to be used.

If the plan is accepted, Tier 2 testing

will then be conducted, analyzed and

reported by the applicant to the

Director.

(ii) The candidate shot and/or coating

will first be run through a standardized

test under in vitro conditions (see

below) that will assess its erosion in an
Federal Register / Vol. 61, No. 18 / Friday, January 26, 1996 / Proposed Rules 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
2476 Federal Register / Vol. 61, No. 18 / Friday, January 26, 1996 / Proposed Rules

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 samesex 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
Federal Register / Vol. 61, No. 18 / Friday, January 26, 1996 / Proposed Rules 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 (α=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 (P≤0.05) 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

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric

Administration

50 CFR Part 646

[I.D. 011696E]

Snapper-Grouper Fishery of the South

Atlantic; Public Scoping Meetings

AGENCY: National Marine Fisheries

Service (NMFS), National Oceanic and

Atmospheric Administration (NOAA),

Commerce.

ACTION: Public scoping meetings.

SUMMARY: The South Atlantic Fishery

Management Council (Council) is

holding two public scoping meetings to

solicit comments on the sale of fish (all

species) caught under the recreational

bag limits established by the Council’s

fishery management plans (FMPs) and

on the issue of recreational catch and

the commercial bycatch of wreckfish

under the Fishery Management Plan for

the Snapper-Grouper Fishery of the

South Atlantic (Snapper-Grouper FMP).

DATES: The public scoping meetings are

scheduled to begin at 6:30 p.m. on

Monday, February 12, 1996, in St.

Augustine, FL, and will end when all

business is completed.

ADDRESSES: The public scoping

meetings will be held in conjunction

with the South Atlantic Fishery

Management Council public meetings to

be held February 12–14, 1996, at the

Ponce de Leon, 4000 US Highway 1

North, St. Augustine, FL 32095;

telephone: (800) 228–2821.

Requests for copies of public scoping

documents should be sent to the

Council at the following address: South

Atlantic Fishery Management Council,

One Southpark Circle, Suite 306,

Charleston, SC 29407–4699.

FOR FURTHER INFORMATION CONTACT:

Robert K. Mahood, Council Executive

Director; telephone: (803) 571–4366; fax:

(803) 769–4520.

SUPPLEMENTARY INFORMATION: At the first

scoping meeting, comments will be

solicited on the sale of fish caught under

the recreational bag limits for all species

as established by the Council’s FMPs.

The Council has considered this issue

on numerous occasions over the past

several years, and both commercial and

recreational fishermen have expressed

concern about this matter. Currently, all

of the Council’s FMPs allow for the sale

of fish taken in a legal bag limit. The

issue regarding the sale of fish caught

under bag limits involves several

considerations, including: (1) The

definitions of recreational and