[Federal Register Volume 61, Number 18 (Friday, January 26, 1996)]
[Proposed Rules]
[Pages 2470-2477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1179]
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DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 20
RIN 1018-AB80
Migratory Bird Hunting: Amended Test Protocol for Nontoxic Shot
Approval Procedures for Shot and Shot Coatings
AGENCY: Fish and Wildlife Service, Interior.
ACTION: Proposed rule.
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SUMMARY: The principal purpose of this action is to promulgate a
rulemaking that will update and amend the current nontoxic shot
approval procedures by establishing a 3-tiered approval process. Shot
approval will be considered at each tier with the testing becoming
progressively more demanding. An environmentally benign shot could be
granted approval at the first tier. This process is designed to include
both candidate shot and shot coatings.
DATES: Comments on this proposal must be received by March 26, 1996.
ADDRESSES: Comments regarding this notice should be addressed to:
Director (FWS/MBMO), U.S. Fish and Wildlife Service, 634 ARLSQ, 1849 C
St., NW., Washington, DC 20240. Comments received on this notice will
be available for public inspection during normal business hours in Room
634, Arlington Square Building, 4401 No. Fairfax Drive, Arlington, VA
22203.
FOR FURTHER INFORMATION CONTACT: Paul Schmidt, Chief, or Keith
Morehouse, Staff Specialist, Office of Migratory Bird Management, 703/
358-1714.
SUPPLEMENTARY INFORMATION: The Service is proposing to revise and
update the existing nontoxic shot approval procedures by establishing a
3-tiered approval process. Shot approval will be considered at each
tier with the testing becoming progressively more demanding. An
environmentally benign shot could be granted approval at the first
tier. This approval process is designed to include both candidate shot
and shot coatings. The Service and applicant have concluded much of the
currently identified nontoxic testing required for bismuth-tin shot and
the process was shown to be both confusing and cumbersome. The Service
believes that this procedure needs to be modified because:
1. From an ecosystem management standpoint, species in addition to
waterfowl species need to be considered;
2. Since the original regulations were promulgated, important
advances have occurred in the field of ecological risk assessment that
can be applied to this process;
3. Time, expense and burden on applicants and the Federal
Government can be reduced without risk to wildlife; and
4. From an animal welfare standpoint, the numbers of test animals
used can be reduced.
It should be noted, however, that while these procedures were put
in place in 1986, the Service had not had any submission requesting
approval of nontoxic shot until the bismuth-tin shot application of
1994. From our experience with the bismuth-tin shot approval process,
it has been determined that procedures should be modified to
accommodate situations where less than full testing is indicated. Thus,
the Service and the National Biological Service (NBS) have
cooperatively developed an alternative draft set of procedures proposed
to be used for approving nontoxic shot as well as coatings that would
replace the testing requirements presently contained in Sec. 20.134. As
with the current procedures, the proposed set of approval procedures
carries the assumption that the applicant has the burden of proof that
the candidate coating or shot is nontoxic.
The system proposed is 3-tiered and is meant to gradually increase
the difficulty of the level of testing based on a test-in/test-out
principle. That is, those candidate materials not approved as a result
of subjecting them to the standards set at Tier 1 would be subjected to
the standards of Tier 2, and so forth, i.e., test-in. If the candidate
material is approved at Tier 1 there would be no requirement to proceed
to Tier 2 or 3, i.e., test-out. The criteria for requiring testing
under Tier 2 standards would be met if data is incomplete or
inconclusive as a result of review of materials and analyses conducted
at Tier 1. Similarly, the criterion for requiring testing under Tier 3
standards would be met if material is found to have some poorly defined
level of toxic effects at Tier 2.
As currently proposed by this regulation, Tier 1 would set out
comprehensive and detailed requirements that must be provided to the
Service in order for the Service to grant approval. Based on the
Service's evaluation of whatever Tier 1 information could be gathered,
the Service would make a decision to grant approval or require Tier 2
testing. That is, the scope of the new procedures outlined in Tier 1
would include: (1) Statements of use, chemical characterization,
production variability and volume of use. The Service would request the
specifics on the chemical compound(s) to be used and a complete
analysis of potential environmental toxicity, as well as the thickness
in the case of coating(s) and percentage of the coating in comparison
to the total shot weight; (2) information on the toxicological effects
of the material, including an ecological risk assessment on the
toxicological effects of the coating and an assessment explaining why
the applicant believes the coating or base material(s) does not pose
toxicity problems for wildlife; and (3) information on the
environmental fate and transport of the material. The Service would
seek information on changes, if any, that are produced by firing the
shot, the estimated half-life of the material and estimates of the
environmental concentrations that are apt to be expected. Tier 1
procedures also contain a set of requirements defining the Service's
responsibility in evaluating the submitted data/information.
Previously codified candidate shot testing procedures would be
divided between Tiers 2 and 3, with the in vitro erosion rate testing
and the short-term (30-day) acute toxicity testing part of Tier 2, and
the chronic exposure under adverse conditions and the chronic exposure
reproduction testing part of Tier 3. Tier 2 will also include a test
protocol that would assess the potential for the candidate shot to
affect aquatic organisms, such as fish and/or
[[Page 2471]]
invertebrates, although it may not require in vivo testing, per se.
Applicants would be required to provide the Service with all the
required information at the time of application or processing would be
delayed. The information provided by the applicant will allow the
Service, or others, to conduct an independent analysis and to make an
informed decision on approval.
A schematic representation of the approval process is provided here
to aid the reader:
BILLING CODE 4310-55-P
[[Page 2472]]
[GRAPHIC] [TIFF OMMITTED] TP26JA96.000
BILLING CODE 4310-55-C
[[Page 2473]]
Although this new set of proposed approval procedures appears to be
more lengthy, the Service feels that it is more flexible and simplifies
the approval process. It is intended that these proposed changes will
allow materials that are somewhat innocuous, with regard to known
toxicity, to be processed more quickly, at lower cost and with less
paperwork for both the applicant and the Service while ensuring that
natural resources are protected.
In 50 CFR 20.134, the Service provides a procedure for approval of
nontoxic shot which has been in effect since 1986; however, it was not
clear that this procedure also pertained to the shot coating which is
applied to prevent corrosion and potential fusion of the shot. Shot
coatings were not given consideration since they are typically quite
thinly applied and constitute a small percent of the pellet by weight.
Nonetheless, the Service is concerned that the coating, although
present in small amounts, may in and of itself be toxic and pose a
hazard to migratory birds or other wildlife. Therefore, the Service is
proposing by this regulation to codify its informal policy on approval
of the types of shot coatings with which a waterfowler may hunt and to
establish a process for that approval.
Earlier, the Service responded to a request from industry and
approved the use of both copper and nickel coatings for steel shot used
in waterfowl hunting. This request specified that coating thickness
would be, nominally, 2 ten-thousandths of an inch thick (0.0002'') and
1 percent or less of the total weight of the shot. These two coatings
had been the only ones approved for waterfowling since May, 1986. More
recently, the Service received a request to approve zinc as a coating
and learned, in the process of acquiring more information, that one
ammunition manufacturer was already marketing a zinc coated steel shot
and another had been planning to market a zinc coated steel shot for,
what was then, an upcoming season (1993-94). Apparently, despite past
efforts to publicize the information, there was no recognition of the
Service's role in this aspect of nontoxic shot regulation in some
quarters and a definite recognition of that role in others. Thus, the
Service perceives there is a need to incorporate into this regulation
standards which allow only approved coatings on pellets utilized in
waterfowl hunting.
In summary, the principal purpose of this action is to promulgate a
rulemaking that will update and amend the current nontoxic shot
approval procedures to include both candidate nontoxic shot and
nontoxic shot coatings.
NEPA Consideration
Pursuant to the requirements of section 102(2)(C) of the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4332(C), and the
Council on Environmental Quality's regulation for implementing NEPA (40
CFR 1500-1508), the Service will comply with NEPA prior to adopting a
final rule.
Endangered Species Act Considerations
Section 7 of the Endangered Species Act (ESA), as amended (16
U.S.C. 1531-1543; 87 Stat. 884), provides that, ``The Secretary shall
review other programs administered by him and utilize such programs in
furtherance of the purposes of this Act'' (and) shall ``insure that any
action authorized, funded or carried out * * * is not likely to
jeopardize the continued existence of any endangered species or
threatened species or result in the destruction or adverse modification
of (critical) habitat * * *'' Consequently, the Service will initiate
Section 7 consultation under the ESA for this proposed rulemaking to
amend the nontoxic shot and shot coating approval process. When
completed, the results of the Service's consultation under Section 7 of
the ESA may be inspected at, and will be available from, the Office of
Migratory Bird Management, U.S. Fish and Wildlife Service, Department
of the Interior, Washington, DC 20240.
Regulatory Flexibility Act, Executive Order 12866, and the Paperwork
Reduction Act
The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.)
requires the preparation of flexibility analyses for rules that will
have a significant effect on a substantial number of small entities,
which includes small businesses, organizations and/or governmental
jurisdictions. However, since this is an amendment to existing
procedures and is designed to reduce the cost and time that is required
to determine the toxicity of a candidate shot, this rule will have no
significant effect on small entities. No dislocation or other local
effects, with regard to hunters and others, are apt to be evidenced.
This rule was not subject to Office of Management and Budget (OMB)
review under Executive Order 12866. This rule does not contain any
additional information collection efforts requiring approval by the OMB
under Public Law 104-13. This rule is being promulgated under existing
Office of Management and Budget information collection requirements
clearance number 1018-0067.
Authorship
The primary authors of this proposed rule are Drs. Keith A.
Morehouse, U.S. Fish and Wildlife Service, and Barnett Rattner,
Patuxent Environmental Science Center, National Biological Service,
Laurel, Maryland.
List of Subjects in 50 CFR Part 20
Exports, Hunting, Imports, Reporting and recordkeeping
requirements, Transportation, Wildlife.
Accordingly, Part 20, Subchapter B, Chapter I of Title 50 of the
Code of Federal Regulations is proposed to be amended as follows:
PART 20--[AMENDED]
1. The authority citation for Part 20 continues to read as follows:
Authority: Migratory Bird Treaty Act (July 3, 1918), as amended
(16 U.S.C. 703-711); the Fish and Wildlife Improvement Act of 1978
(November 8, 1978), as amended (16 U.S.C. 712); and the Fish and
Wildlife Act of 1956 (August 8, 1956), as amended (16 U.S.C. 742 a-d
and e-j).
2. Section 20.134 is amended by revising paragraph (b) as set forth
below and removing paragraph (c):
Sec. 20.134 Nontoxic shot.
* * * * *
(b) Application and review. Tiered Strategy for Approval of
Nontoxic Shot and Anti-corrosion Thin-Coating for Nontoxic Shot.
(1) All applications for approval under these sections will be
submitted with supporting documentation to the Director in accordance
with the following procedures, and will include at a minimum the
supporting materials and information covered by Tier 1 in the tiered
approval system as follows:
(2) Tier 1. (i) (A) Applicant provides statements of use, chemical
characterization, production variability, volume of use of material
requested to be approved and shot sample as listed in paragraphs
(b)(2)(i)(A) (1) through (5) of this section. The candidate shot and/or
coating may be chemically analyzed by the Service or an independent
laboratory and the results will be compared to the applicant's
descriptions of shot composition and composition variability. If the
application is incomplete or if the composition of the candidate
material, upon analysis, varies from that described by the applicant it
will be rejected.
(1) Statement of proposed use, i.e., purpose and types.
[[Page 2474]]
(2) Description of the chemical composition of the intact material.
(i) Chemical names, Chemical Abstracts Service numbers, and
structures.
(ii) Chemical characterization for organics and organometallics for
coating and core (e.g., empirical formula, melting point, molecular
weight, solubility, specific gravity, partition coefficients,
hydrolysis half-life, leaching rate (in water and soil) degradation
half-life, vapor pressure, stability and other relevant
characteristics).
(iii) Composition and weight of shot material.
(iv) Thickness, quantity (e.g., mg/shot), and chemical composition
of coating per shot.
(3) Statement of the expected variability of shot coating or shot
during production.
(4) Estimate of yearly volume of coated shot or shot used for
hunting migratory birds in the U.S.
(5) 25 pounds of the candidate shot and/or shot with coating, as
applicable, in size equivalent to United States standard size No. 4
(0.17 inches in diameter).
(B) Applicant provides information on the toxicological effects of
the shot coating and/or shot as follows:
(1) A brief synopsis of the acute and chronic mammalian toxicity
data of the shot coating and/or shot material ranking its toxicity
(e.g., LD50<5 mg/kg = super-toxic, 5-50 mg/kg = extremely toxic, 50-500
mg/kg = very toxic, 500-5,000 mg/kg = moderately toxic, 5,000-15,000 =
slightly toxic, >15,000 mg/kg = practically nontoxic).
(2) A summary of known toxicological data of the chemicals
comprising the shot and/or shot coating material with respect to birds,
particularly waterfowl (include LD50 or LC50 data, and sublethal
effects).
(3) A narrative description of the toxic effect of complete erosion
and absorption of the shot and/or coating material in a 24-hour period.
(Define the nature of toxic effect--e.g., mortality, impaired
reproduction, substantial weight loss, disorientation and other
relevant associated observations.)
(4) A statement that there is or is not any basis for concern for
shot or coated shot material ingestion by fish or mammals. If there is
some recognized impact on mammals or fish, the Service may require
additional study.
(5) Summarize the toxicity data of the shot and/or shot coating
material to aquatic and terrestrial invertebrates, amphibians and
reptiles.
(C) Applicant provides information on the environmental fate and
transport, if any, of the shot and/or shot coating material as follows:
(1) A statement that the shot coatings and/or shot is or is not
chemically or physically altered upon firing. If so, the statement must
describe any alterations.
(2) An estimate of the environmental half-life of the shot and/or
shot coating and a description of the chemical form of the breakdown
products of the shot coating and/or shot.
(3) Information on the Estimated Environmental Concentration (EEC)
assuming 69,000 shot per hectare (Bellrose 1959) for:
(i) A terrestrial ecosystem, assuming complete erosion of material
in 5 cm of soil. What would be the EEC and does the EEC exceed existing
clean soil standards? (Environmental Protection Agency [EPA] standards
for the Use of Disposal of Sewage Sludge; 40 CFR Part 503). What is the
estimated EEC and how does that relate to the toxicity threshold for
plants, invertebrates, fish and wildlife?
(ii) An aquatic ecosystem, assuming complete erosion of the shot
coating and/or shot in 1 cubic foot of water. What is the estimated
EEC, and how does it compare to the EPA Water Quality Criteria and
toxicity thresholds in plants, invertebrates, fish and wildlife.
(D) Fish and Wildlife Service evaluation of an application.
(1) The Service will conduct a risk assessment using 1 LD50/square
foot as the level of concern based on granular pesticides.
(2) In cooperation with the applicant, the Service will conduct a
risk assessment using the Quotient Method (Barnthouse et al. 1982):
Risk = EEC/Toxicological Level of Concern Compare EEC in ppm to an
effect level (e.g., LD50 in ppm). If Q < 0.1 = No Adverse Effects; If
0.1 Q 10.0 = Possible Adverse Effects; If Q >
10.0 = Probable Adverse Effects.
(ii) Upon receipt of the Tier 1 application, the Director will
review it to determine if the submission is complete. If complete, the
applicant will be notified within 30 days of receipt that a thorough
review of the application will commence. A Notice of Review will be
published in the Federal Register announcing the initiation of review
of a Tier 1 application. Review of a Tier 1 application will be
concluded within 60 days of the date published in the Notice of Review.
(iii) If after review of the Tier 1 test data materials the Service
determines that the information does not conclusively establish that
the shot and coating material do not impose a significant danger to
migratory birds and other wildlife and their habitats or that
significant data are incomplete, the applicant will be advised to
proceed with the additional testing described in Tier 2. The public
will be informed by a Notice of Review that Tier 1 test results are
inconclusive and Tier 2 testing has been recommended.
(iv) If review of the Tier 1 test data results in a preliminary
determination that the candidate materials do not impose a significant
danger to migratory birds and other wildlife and their habitats, the
Director will publish in the Federal Register a proposed rule stating
the Service's intention to approve this shot and/or coating. The
rulemaking will include a description of the chemical composition of
the candidate shot and/or coating and a synopsis of findings under the
standards required for Tier 1. If, at the end of the comment period,
the Service finds no technical or scientific basis upon which to deny
approval, the candidate material will be approved by the publication of
a final rule in the Federal Register. If as a result of the comment
period, the Service determines that the information does not
conclusively establish that the shot and/or coating material do not
impose a significant danger to migratory birds and other wildlife and
their habitats, Tier 2 testing will be recommended and a Notice of
Review will be published in the Federal Register. If the applicant
chooses not to proceed, the determination denying approval will be
published in the Federal Register.
(3) Tier 2, (i) Upon determination that Tier 1 information is
inconclusive, the applicant will be notified by the Director to submit
a Tier 2 testing plan for conducting further testing as outlined in
paragraphs (b)(3)(ii), (A), (B) and (C) of this section. The Tier 2
testing plan submitted by the applicant will be reviewed by the
Director within 30 days of receipt. The Director may decline to approve
the plan, or any part of it, if deficient in any manner with regard to
timing, format or content. The Director shall apprise the applicant
regarding what parts, if any, of the submitted testing procedures need
not be conducted and any modifications that must be incorporated into
the Tier 2 testing plan. The Director, or authorized representative,
may elect to inspect laboratory facilities to be used. If the plan is
accepted, Tier 2 testing will then be conducted, analyzed and reported
by the applicant to the Director.
(ii) The candidate shot and/or coating will first be run through a
standardized test under in vitro conditions (see below) that will
assess its erosion in an
[[Page 2475]]
environment simulating in vivo conditions of a waterfowl gizzard, and
any release of components into a liquid medium. Erosion characteristics
will be compared to those of lead shot and steel shot of comparable
size. Following the erosion rate testing, the candidate shot and/or
coating will be subjected to a 30-day acute toxicity test and a test to
determine its affects on selected fish and invertebrates.
(A) Conduct a standardized in vitro test to determine erosion rate
of the candidate shot and/or coating using the general guidelines as
follows: Standardized Test for Erosion Rate. (Ref.: Kimball, W.H., and
Z.A. Munir. 1971. The corrosion of lead shot in a simulated waterfowl
gizzard. J. Wildl. Manage. 35(2):360-365.)
(1) Typical Test Materials.
Atomic absorption spectrophotometer.
Drilled aluminum block to support test tubes.
Thermostatically controlled stirring hot plate.
Small teflon-coated magnets.
Hydrochloric acid (pH 2.0) and pepsin.
Capped test tubes.
Lead, steel and candidate shot (if appropriate).
(2) Typical Test Procedures. Hydrochloric acid and pepsin are added
to each capped test tube at a volume and concentration that will erode
a single #4 lead shot at a rate of 5 mg/day. Three test tubes, each
containing either lead shot, steel shot or candidate shot and/or
coating, are placed in the aluminum block on the stirring hot plate. A
teflon coated magnet is added to each test tube and the hot plate is
set at 42 degrees centigrade and 500 revolutions per minute. Erosion of
shot and/or coating will be determined on a daily basis for 14
consecutive days by weighing the shot and analyzing the digestion
solution with an atomic absorption spectrophotometer. The 14-day
procedure will be replicated five times.
(3) Typical Test Analyses. Erosion rates of the three types of shot
will be compared by appropriate analysis of variance and regression
procedures. The statistical analysis will determine whether the rate of
erosion of the candidate shot and/or coating is significantly greater
or less than that of lead and steel. This determination is important to
any subsequent toxicity testing.
(ii) Acute Toxicity Test--Tier 2 (Short-term, 30-day acute toxicity
test using a commercially available duck food.). Over a 30-day period,
conduct a short-term acute toxicity test that complies with the general
guidelines described as follows:
(1) Typical Test Materials.
48 male and 48 female hand-reared mallards approximately 6 to 8
months old.
Mallards must have plumage and body conformation that resemble wild
mallards.
96 outdoor pens equipped with food containers and water.
Laboratory equipped to perform fluoroscopy, required blood and
tissue assays.
Commercial duck food.
Lead, steel and candidate shot.
(2) Typical Test Procedures. Mallards will be housed individually
in pens and given ad libitum access to food and water. After 3 weeks,
they will be randomly assigned to 6 groups (8 males and 8 females/
group), dosed with 8 pellets of No. 4 lead, steel, or the candidate
shot and/or coatings. Birds will be fluoroscoped 1 week after dosage to
check for shot retention. Birds will be observed daily for signs of
intoxication and mortality over a 30-day period. Body weight will be
determined at the time of dosing, and at day 15 and 30 of the test. On
days 15 and 30 blood will be collected by venipuncture for
determination of hematocrit, hemoglobin concentration and other
specified blood chemistries. All survivors will be sacrificed on day
30. The liver and other appropriate organs will be removed from the
sacrificed birds and from other birds dying prior to sacrifice on day
30 for histopathological analysis. The organs will be analyzed for lead
and compounds contained in the candidate shot and/or shot coatings. All
birds will be necropsied to determine any pathological conditions.
(3) Typical Test Analyses. Mortality among the specified groups
will be analyzed with appropriate chi-square statistical procedures.
Physiological data and tissue contaminant data will be analyzed by
analysis of variance or other appropriate statistical procedures to
include the factors of shot type and sex. Comparison between sacrificed
birds and birds dying before sacrifice will be made whenever sample
sizes are adequate for meaningful comparison. Procedures should be in
compliance with the Good Laboratory Practices Standards (40 CFR Part
160). The applicant will ensure that copies of all the raw data and
statistical analyses accompany the laboratory reports and final
comprehensive report of this test when they are sent to the Director.
(C) Daphnid and Fish Early-Life Toxicity Tests. Determine the
toxicity of the shot or shot coating (whole shot and eroded coating) to
selected fish and invertebrates subject to the environmental effects
test regulations developed under the authority of the Toxic Substances
Control Act (15 U.S.C. 2601 et seq.), as follows:
(1) The first test, the Daphnid Acute Toxicity Test (40 CFR Section
797.1300), is a guideline for use in developing data on the acute
toxicity of chemical substances. This guideline prescribes an acute
toxicity test in which daphnids are exposed to a chemical in a static
and flow-through system with the resulting data used by the agencies to
assess the hazard that the chemical may present to an aquatic
environment.
(2) The second test is the Daphnid Chronic Toxicity Test (40 CFR
Section 797.1330) and is used to develop data on the chronic toxicity
of chemical substances in which daphnia are exposed to a chemical in a
renewal or flow-through system. The data from this test are again used
to assess the hazard that chemical may present to an aquatic
environment.
(3) A third test, Fish Early Life Stage Toxicity Test (40 CFR
Section 797.1600), is required and is a test to assess the adverse
effects of chemical substances to fish in the early stages of their
growth and development. Data from this test are also used to determine
the hazard a chemical may present to an aquatic environment.
(iii) After the Tier 2 testing is concluded, the applicant will
report the results to the Director. Submitted materials will include
test results (data analysis reports, lab data) and a written final
report. If after review of the Tier 2 test data the Service determines
that the information does not conclusively establish that the shot and/
or coating material do not impose a significant danger to migratory
birds and other wildlife and their habitats or that significant data
are missing and/or incomplete, the applicant will be advised to proceed
with the additional testing described in Tier 3. The public will be
informed by a Notice of Review that Tier 2 test results are
inconclusive and Tier 3 testing has been recommended.
(iv) If review of the Tier 2 test data results in a preliminary
determination that the candidate shot and/or coating materials do not
impose a significant danger to migratory birds and other wildlife and
their habitats, the Director will publish in the Federal Register a
proposed rule stating the Service's intention to approve this shot and/
or coating. The rulemaking will include a description of chemical
composition of the candidate shot and/or coating and a synopsis of
findings under the standards required at Tier 2. If at the end of the
comment period, the Service finds no technical or scientific basis upon
which to deny approval, the candidate shot and/or coating material will
be
[[Page 2476]]
approved by publication of a final rule in the Federal Register. If, as
a result of the comment period, the Service determines that the
information does not conclusively establish that the shot and coating
material do not impose a significant damage to migratory birds and
other wildlife habitats, Tier 3 testing will be recommended and a
Notice of Review will be published in the Federal Register. If the
applicant chooses not to proceed, the determination denying approval
will be published in the Federal Register denying approval of the
candidate shot.
(4) Tier 3.
(i) Upon determination that the Tier 2 information is inconclusive,
the applicant will be notified by the Director to submit a Tier 3
testing plan for conducting further testing as outlined in paragraphs
(b)(4)(i) (A) and (B) of this section. The Tier 3 testing plan
submitted by the applicant will be reviewed by the Director within 30
days of receipt. The Director may decline to approve the plan, or any
part of it, if deficient in any manner with regard to timing, format or
content. The Director shall apprise the applicant regarding what parts,
if any, of the submitted testing procedure need not be conducted and
any modifications that may be necessary to incorporate into the Tier 3
plan. The Director, or authorized representative, may elect to inspect
laboratory facilities to be used. If the plan is accepted, Tier 3
testing will then be conducted, analyzed and reported by the applicant
to the Director.
(A) Chronic Toxicity Test--Tier 3 (Long-term, 8-9 week toxicity
test under depressed temperature conditions using a nutritionally-
deficient diet.). Conduct a chronic exposure test under adverse
conditions that complies with the general guidelines described as
follows:
(1) Typical Test Materials.
36 male and 36 female hand-reared mallards approximately 6 to 8
months old. The mallards must have plumage and body conformation
that resembles wild mallards.
72 elevated outdoor pens equipped with food containers and waterers.
Laboratory equipped to perform fluoroscopy, required blood and
tissue assays, and necropsies.
Whole kernel corn.
Lead, steel, and candidate shot with or without coating, or coating,
as applicable.
(2) Typical Test Procedures. (i) This test will be conducted at a
location where the mean monthly low temperature during December through
March is between 20 and 40 degrees Fahrenheit (-6.6 and 4.4 degrees
centigrade, respectively). Mallards will be individually assigned to
elevated outdoor pens during the first week of December and acclimated
to an ad libitum diet of whole kernel corn for 2 weeks. Birds will be
randomly assigned to 5 groups (lead group of 4 males and 4 females, 4
other groups of 8 males and 8 females/group). The lead group will be
dosed with 1 size No. 4 pellet of lead. One group (8 males and 8
females) will be dosed with 8 size No. 4 pellets of steel and the 3
other groups (8 males and 8 females/group) will be dosed with 1, 4 and
8 size No. 4 pellets of candidate shot and/or coating, respectively.
(ii) Birds will be weighed and fluoroscoped weekly. All recovered
shot will be weighed to measure erosion. Blood parameters given in the
30-day acute toxicity test will again be determined in this procedure.
Body weight and blood parameter measurements will be made on samples
drawn at 24 hours after dosage and at the end of days 30 and 60. At the
end of 60 days, all survivors will be sacrificed. The liver and other
appropriate organs will be removed from the sacrificed birds and birds
dying prior to sacrifice on day 60 for histopathological analysis. The
organs will be analyzed for lead and other metals contained in the
steel and candidate shot and/or coating. All birds dying prior to
sacrifice will be necropsied to determine pathological conditions
associated with death.
(3) Typical Test Analyses. Mortality among the specified groups
will be analyzed with appropriate chi-square statistical procedures.
Any effects on the previously mentioned physiological parameters caused
by the candidate shot and/or coating must be significantly less than
those caused by lead shot and must not be significantly greater than
those caused by steel shot. Physiological data and tissue contaminant
data will be analyzed by analysis of variance or appropriate
statistical procedures to include the factors of shot type, dose and
sex. Comparisons between sacrificed birds and birds dying before
sacrifice will be made whenever sample sizes are adequate for a
meaningful comparison. Procedures should be in compliance with the Good
Laboratory Practices Standards (40 CFR Part 160). The applicant will
ensure that copies of all the raw data and statistical analyses
accompany the lab analyses and final comprehensive reports of this test
when they are sent to the Director.
(B) Chronic Dosage Study--Tier 3 (Moderately long-term study that
includes reproductive assessment.). Conduct chronic exposure
reproduction trial with the general guidelines described as follows:
(1) Typical Test Materials.
60 male and 60 female hand-reared first year mallards. These
mallards must have plumage and body conformation that resemble wild
mallards.
Pens suitable for quarantine and acclimation and for reasonably
holding 5-10 ducks each.
60 elevated, pens equipped with feeders, waterers and nest boxes.
Laboratory equipped to perform fluoroscopy and required blood
assays.
Corn and commercial duck breeder mash.
Steel and candidate shot and/or coating, as applicable.
(2) Typical Test Procedures. (i) Mallards will be randomly assigned
to 2 groups (30 males and 30 females/group) in December and held in
same-sex groups until mid-January (dates apply to outdoor test facility
only and will reflect where in the U.S. tests are conducted). After a
3-week acclimation period, birds will be provided an ad libitum diet of
corn for 60 days and are then paired (one pair/pen) and switched to
commercial mash. Dosing of the 2 groups with 8 pellets of No. 4 steel
(group 1) and candidate shot and/or coating (group 2) will occur after
the acclimation period (day 0) and redosed after 30, 60, and 90 days.
(ii) Birds will be fluoroscoped 1 week after dosage to check shot
retention. Males and females will be weighed the day of initial dosing
(day 0), at each subsequent dosing, and at death. Blood parameters
identified in the 30-Day Acute Toxicity Test will again be measured in
this test using samples drawn at time of weighing. The date of first
egg will be noted as will the mean number of days per egg laid. Laying
will be concluded after 21 normal, uncracked eggs are laid or after 150
days, at which time the adults will be sacrificed. The liver and other
appropriate organs will be removed from the sacrificed birds and from
other birds dying prior to sacrifice for histopathological analysis.
The organs and the 11th egg will be analyzed for compounds contained in
the candidate shot or shot coatings. All birds will be necropsied to
determine any pathological conditions. Nests will be checked daily to
collect eggs. Any eggs laid before pairing will be discarded. Eggs will
be artificially incubated and the percent shell-less, percent eggs
cracked, percent fertility (as determined by candling), and percent
hatch of fertile eggs will be calculated for each female. Ducklings
will be provided with starter mash after hatching. All ducklings will
be sacrificed when reaching 14 days of age. Survival to day 14 and
weight of the ducklings at hatching and sacrifice will be measured.
Blood parameters identified in the 30-Day Acute Toxicity Test will be
[[Page 2477]]
measured using samples drawn when sacrificed.
(3) Typical Test Analyses.
Any mortality, reproductive inhibition or effects on the previously
mentioned physiological parameters by the candidate shot and/or coating
must not be significantly greater that those caused by steel shot.
Percentage data will be subjected to an arcsine, square root
transformation prior to statistical analyses. Physiological and
reproductive data will be analyzed by one-tailed t-tests
(=0.05), or other appropriate statistical procedures.
Procedures should be in compliance with the Good Laboratory Practice
Standards (40 CFR Part 160). The applicant will ensure that copies of
all raw data and statistical analyses accompany the lab analyses and
comprehensive reports of this test when they are sent to the Director.
(ii) After the Tier 3 testing is concluded, the applicant will
report the results to the Director. Submitted materials will include
test results (data analysis reports, lab data) and a written final
report. If after review of the Tier 3 test data (to be completed 60
days after receipt of material) the Service determines that the
information does not conclusively establish that the shot and/or
coating material do not impose a significant danger to migratory birds
and other wildlife and their habitats, or that significant data are
incomplete, the applicant will be given the option of repeating the
tests in Tier 3 that were deemed inconclusive. If the applicant chooses
not to repeat the tests, approval of the candidate shot and/or coating
will be denied. The public will be informed by a Notice of Review that
Tier 3 test results are inconclusive and of the applicant's decision
not to repeat Tier 3 testing. The publication will state that approval
of candidate shot and/or coating is denied.
(iii) If review of either the initial or repeated Tier 3 test data
results in a preliminary determination that the candidate materials do
not impose a significant danger to migratory birds and other wildlife
and their habitats, the Director will publish in the Federal Register a
proposed rule stating the Service's intention to approve this shot and/
or coating. The rulemaking will include a description of chemical
composition of the candidate shot and/or coating and a synopsis of
findings under the standards required by Tier 3. If at the end of the
comment period, the Service finds no technical or scientific basis upon
which to deny approval, the candidate shot and/or coating material will
be approved by publication of a final rule in the Federal Register. If,
as a result of the comment period the Service determines that the
information does not conclusively establish that the shot and/or
coating material do not impose a significant danger to migratory birds
and other wildlife and their habitats, the applicant will be given an
opportunity to answer the concerns expressed by the comments with
additional testing. The decision to conduct additional testing will be
published as a Notice of Review. If the applicant chooses not to
proceed, the final determination denying approval will be published in
the Federal Register.
(iv)(A) The Tier 2 toxicity tests involving invertebrates and
early-life stage vertebrates are intended to assess potential impacts
on waterfowl habitat. The three toxicity tests with waterfowl described
in Tiers 2 and 3 represent an evaluation of the three major categories
of toxic effects: short-term periodic exposure; chronic exposure under
adverse environmental conditions; and chronic exposure impact on
reproduction. In the appropriate situations, the test animals will be
exposed to the candidate material: both acutely and chronically; both
stressed and non-stressed by diet and temperature; and with comparisons
made to lead and steel shot regarding mortality and sublethal effects.
The inclusion of lead shot and steel shot control groups in the
waterfowl feeding studies is considered necessary for dealing with the
experimental variability associated with tests being performed by
different laboratories under a variety of conditions beyond control of
the experimental protocol. Toxicity tests described in this rule are
designed for testing the effects of metal or metalloid shot. The
details of the experimental procedures can be modified, if necessary,
to address the specific composition and erosion characteristics of the
candidate shot. If the candidate shot is not metal or metalloid, other
testing procedures will have to be developed and approved to evaluate
the effects of the components of the candidate shot and/or coating
materials.
(B) Statistical analyses will be performed on all data from each
test. For the purpose of this section (20.134) the terms significant
and significantly refer to a (P0.05) finding of
significance.
Dated: October 25, 1995.
George T. Frampton, Jr.,
Assistant Secretary for Fish and Wildlife and Parks.
[FR Doc. 96-1179 Filed 1-25-96; 8:45 am]
BILLING CODE 4310-55-P