[Federal Register Volume 62, Number 230 (Monday, December 1, 1997)]
[Rules and Regulations]
[Pages 63608-63615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31328]



[[Page 63607]]

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Part II





Department of the Interior





_______________________________________________________________________



Fish and Wildlife Service



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50 CFR Part 20



Migratory Bird Hunting: Revised Test Protocol for Nontoxic Approval 
Procedures for Shot and Shot Coating; Final Rule

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

[[Page 63608]]


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DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

50 CFR Part 20

RIN 1018-AB80


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

AGENCY: Fish and Wildlife Service, Interior.

ACTION: Final rule.

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SUMMARY: The purpose of this action is to revise the current nontoxic 
shot approval procedures by establishing a tiered approval process. 
Shot or shot coating approval is considered at each tier. An 
environmentally benign shot or a minor modification of previously 
approved shot may receive nontoxic approval after the first tier 
contingent on existence of appropriate toxicological data and an 
ecological risk assessment. If not, further testing would be required.

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

ADDRESSES: Director (FWS/MBMO), U.S. Fish and Wildlife Service, 634 
ARLSQ, 1849 C ST., NW, Washington, D.C. 20240.

FOR FURTHER INFORMATION CONTACT: Paul Schmidt, Chief, or Carol 
Anderson, Wildlife Biologist, Office of Migratory Bird Management, 703/
358-1714.

SUPPLEMENTARY INFORMATION: The U.S. Fish and Wildlife Service (Service) 
is revising the existing nontoxic shot and shot coating approval 
procedures (50 CFR 20.134) by establishing a three-tier approval 
process. Shot or shot coating approval is considered at each tier. An 
environmentally benign shot or a minor modification of previously 
approved shot may receive nontoxic approval after the first tier 
contingent upon the existence of appropriate toxicological data and an 
ecological risk assessment. The Service has modified the existing 
regulation because:
    1. From an ecosystem management perspective, in addition to 
waterfowl, we need to evaluate species such as invertebrates and fish 
as these provide a food base for many waterfowl species;
    2. Since the original regulations were in effect, advancements in 
the field of ecological risk assessment can be applied to this process;
    3. Reduction of time, expense and burden on the Federal Government 
and applicants can occur without risk to wildlife; and
    4. From an animal welfare standpoint, reduction in numbers of test 
animals used can occur without risk to wildlife.
    The original procedures were put in place in 1986 and the first 
submission requesting approval of nontoxic shot came in October of 
1993. Our experience with this shot approval process has shown that the 
procedures need modification to accommodate situations where existing 
information can minimize the need for full testing. Thus, the Service 
and the U.S. Geological Survey--Biological Resources Division 
cooperatively have developed an alternative set of procedures for 
evaluating nontoxic shot and shot coatings to replace the testing 
requirements presently in effect. As with the current procedures, the 
new set of approval procedures carry the requirement that the applicant 
carry the burden of providing that the candidate shot or shot coating 
is nontoxic.
    The system has three tiers, with each tier enhancing the 
information base on the candidate material. Those candidate materials 
where appropriate background information, toxicological data, 
ecological risk assessment, and reproductive effects information are 
available demonstrating the candidate material to be benign may receive 
nontoxic approval. Those candidate materials not approved as a result 
of subjecting them to the standards set at Tier 1 will be subject to 
the standards of Tier 2, Tier 3, or both.
    Tier 1 sets out comprehensive and detailed requirements that must 
be provided to the Service in order to consider approval. After 
evaluation of Tier 1 information, the Service will determine to grant 
or deny approval, or require testing of Tier 2, Tier 3, or both.
    The scope of Tier 1 includes: (1) Physical and chemical 
characterization of candidate shot or shot coating; (2) information on 
the toxicity of the candidate material; (3) an ecological risk 
assessment; and (4) effects on reproduction in water birds of the 
candidate material.
    The scope of Tier 2 includes in vitro erosion rate testing, short-
term (30-day) acute toxicity testing on mallards, and toxicity tests 
with invertebrates and early-life stage vertebrates to assess potential 
impacts on waterfowl habitat. The inclusion of lead shot (positive) and 
steel shot (negative) control groups in the waterfowl feeding studies 
is necessary to account for the experimental variability associated 
with: (1) Tests performed by different laboratories; (2) a series of 
tests performed within a given laboratory; and/or (3) an individual 
test, given changing conditions which are beyond control of the 
experimental protocol. Further, although the positive control group is 
essential to every shot ingestion study series, the Service has 
considered the documented history of the results of lead shot ingestion 
by waterfowl and reduced the numbers of birds required for that aspect 
of the protocol.
    The scope of Tier 3 includes chronic exposure under adverse 
environmental conditions and effects on reproduction in mallards.
    Modification of the experimental procedures to address the specific 
composition and erosion characteristics of the candidate shot or shot 
coating may be made by the Service, if necessary. If the candidate shot 
or shot coating is not metal or metalloid, the Service, with the 
applicant, may develop other equivalent testing procedures to evaluate 
the effects of the components of the candidate shot and/or shot 
coating.
    Statistical analyses are to be performed on all data from each 
test. For the purpose of this section (20.134) the terms significant 
and significantly refer to a (P0.05) finding of 
significance.
    Other conditions of final approval include residual lead levels and 
noninvasive field testing devices. The Service has established a 
maximum environmentally acceptable level of lead in shot as trace 
amounts of <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:

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[GRAPHIC] [TIFF OMITTED] TR01DE97.000



BILLING CODE 4310-55-C

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    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.

[[Page 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 Sec. 20.134 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 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.

[[Page 63612]]

    (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

[[Page 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 4 lead shot at a rate of 5 mg/day. Place three test 
tubes, each containing either lead shot, steel shot or candidate shot 
and/or coated shot, in an aluminum block on the stirring hot plate. Add 
a Teflon coated magnet to each test tube and set the hot 
plate at 42 degrees centigrade and 500 revolutions per minute. 
Determine the erosion of shot or coated shot daily for 14 consecutive 
days by weighing the shot and analyzing the digestion solution with an 
atomic absorption spectrophotometer. Replicate the 14-day procedure 
five times.
    (3) Typical test analyses. Compare erosion rates of the three types 
of shot by appropriate analysis of variance and regression procedures. 
The statistical analysis will determine whether the rate of erosion of 
the shot and/or shot coating is significantly greater or less than that 
of lead and steel. This determination is important to any subsequent 
toxicity testing.
    (B) Acute Toxicity Test--Tier 2 (Short-term, 30-day acute toxicity 
test using a commercially available duck food.). Over a 30-day period, 
conduct a short-term acute toxicity test that complies with the 
guidelines described as follows or as otherwise provided by the 
Service:
    (1) Typical test materials: 30 male and 30 female hand-reared 
mallards approximately 6 to 8 months old (mallards must have plumage 
and body conformation that resemble wild mallards); 60 elevated outdoor 
pens equipped with feeders and waterers; Laboratory equipped to perform 
fluoroscopy, required blood and tissue assays, and necropsies; 
Commercial duck maintenance mash; and Lead, steel and candidate shot.
    (2) Typical test procedures. House mallards individually in pens 
and give ad libitum access to food and water. After 3 weeks, randomly 
assign to 3 groups (10 males and 10 females/group), dose with eight 
pellets of either No. 4 lead shot (positive control), steel shot 
(negative control), or the candidate shot or coated shot. Fluoroscope 
birds at 1 week after dosage to check for shot retention. Observe birds 
daily for signs of intoxication and mortality over a 30-day period. 
Determine body weight at the time of dosing, and at days 15 and 30 of 
the test. On days 15 and 30, collect blood by venipuncture, determine 
hematocrit, hemoglobin concentration and other specified blood 
chemistries. Sacrifice all survivors on day 30. Remove the liver and 
other appropriate organs from the sacrificed birds and from birds that 
died prior to sacrifice on day 30 for histopathological analysis. 
Analyze the organs for lead and compounds contained in the candidate 
shot or coated shot. Necropsy all birds to determine any pathological 
conditions.
    (3) Typical test analyses. Analyze mortality among the specified 
groups with appropriate chi-square statistical procedures. Analyze 
physiological data and tissue contaminant data by analysis of variance 
or other appropriate statistical procedures to include the factors of 
shot type and sex. Compare sacrificed birds and birds that died prior 
to sacrifice whenever sample sizes are adequate for meaningful 
comparison.
    (C) Daphnid and Fish Early-Life Toxicity Tests. Determine the 
toxicity of the compounds that comprise the shot or shot coating (at 
conditions maximizing solubility without adversely affecting controls) 
to selected invertebrates and fish. These methods are subject to the 
environmental effects test regulations developed under the authority of 
the Toxic Substances Control Act (15 U.S.C. 2601 et seq.), as follows:
    (1) The first test, the Daphnid Acute Toxicity Test (conducted in 
accordance with 40 CFR 797.1300), is a guideline for use in developing 
data on the acute toxicity of chemical substances. This guideline 
prescribes an acute toxicity test in which Daphnid exposure to a 
chemical in static and flow-through systems, with the agencies 
assessing the hazard the compound(s) may present to an aquatic 
environment.
    (2) The second test is the Daphnid Chronic Toxicity Test (conducted 
in accordance with 40 CFR 797.1330). This gathers data on the chronic 
toxicity of chemical substances in which Daphnids (Daphnia spp.) are 
exposed to a chemical in a renewal or flow-through system. The data 
from this test are again used to assess the hazard that the compound(s) 
may present to an aquatic environment.
    (3) A third test, Fish Early Life Stage Toxicity Test (conducted in 
accordance with 40 CFR Section 797.1600), assesses the adverse effects 
of chemical substances to fish in the early stages of their growth and 
development. Data from this test are used to determine the hazard the 
compound(s) may present to an aquatic environment.
    (iii) After the Tier 2 testing, the applicant will report the 
results to the Director. If, after review of the Tier 2 data, the 
Service determines that the information does not establish that the 
shot or shot coating does not impose a significant danger to migratory 
birds, other wildlife, and their habitats, the applicant is advised to 
proceed with the additional testing in Tier 3. A Notice of Review 
advises the public that, in conjunction with Tier 1 data, Tier 2 test 
results are inconclusive and Tier 3 testing is required for continued 
consideration.
    (iv) If review of the Tier 2 test data results in a preliminary 
determination that the candidate shot or shot coating does not impose a 
significant danger to migratory birds, other wildlife, and their 
habitats, the Director will publish in the Federal Register a proposed 
rule stating the Service's intention to approve this shot and/or 
coating and why Tier 3 testing is unnecessary. The rulemaking will 
include a description of chemical composition of the shot or shot 
coating, and a synopsis of findings under the standards required at 
Tier 2. If, at the end of the comment period, the Service finds no 
technical or scientific basis upon which to deny approval, the 
candidate shot or shot coating approval is published as a final rule in 
the Federal Register. If, as a result of the comment period, the 
Service determines that the information does not establish that the 
shot and/or shot coating does not impose a significant danger to 
migratory birds, other wildlife, and their habitats, Tier 3 testing 
will be required and a Notice of Review published in the

[[Page 63614]]

Federal Register. If the applicant chooses not to proceed, the 
determination denying approval of the candidate shot or shot coating 
will appear in the Federal Register.
    (4) Tier 3. 
    (i) If the Director determines that the Tier 1 or Tier 2 
information is inconclusive, the Director will notify the applicant to 
submit a Tier 3 testing plan for conducting further testing as outlined 
in paragraphs (b)(4)(i) (A) and (B) of this section. Review, by the 
Director, of the Tier 3 testing plan submitted by the applicant will 
occur within 30 days of receipt. The Director may decline to approve 
the plan, or any part of it, if deficient in any manner with regard to 
timing, format or content. The Director shall apprise the applicant 
regarding what parts, if any, of the submitted testing procedure to 
disregard and any modifications to incorporate into the Tier 3 plan in 
order to gain plan approval. All testing procedures should be in 
compliance with the Good Laboratory Practices Standards (40 CFR part 
160), except where they conflict with the regulations in this section 
or with a provision of an approved plan. The Director, or authorized 
representative, may elect to inspect the applicant's laboratory 
facilities and may decline to approve the plan and further 
consideration of the candidate shot and/or shot coating if the facility 
is not in compliance with the Good Laboratory Practices Standards. 
After acceptance of the plan, Tier 3 testing will commence. Required 
analyses and reports must be sent to the Director. The applicant will 
ensure that copies of all the raw data and statistical analyses 
accompany the laboratory reports and final comprehensive report of this 
test.
    (A) Chronic Toxicity Test--Tier 3 (Long-term toxicity test under 
depressed temperature conditions using a nutritionally-deficient diet). 
Conduct a chronic exposure test under adverse conditions that complies 
with the general guidelines described as follows unless otherwise 
provided by the Service:
    (1) Typical test materials: 36 male and 36 female hand-reared 
mallards approximately 6 to 8 months old (Mallards must have plumage 
and body conformation that resembles wild mallards); 72 elevated 
outdoor pens equipped with feeders and waterers; Laboratory equipped to 
perform fluoroscopy, required blood and tissue assays, and necropsies; 
Whole kernel corn; and Lead, steel, and candidate shot or coated shot.
    (2) Typical test procedures.
    (i) Conduct this test at a location where the mean monthly low 
temperature during December through March is between 20 and 40 degrees 
Fahrenheit (-6.6 and 4.4 degrees centigrade, respectively). Assign 
individual mallards to elevated outdoor pens during the first week of 
December and acclimate to an ad libitum diet of whole kernel corn for 2 
weeks. Randomly assign birds to 5 groups (lead group of 4 males and 4 
females, 4 other groups of 8 males and 8 females/group). Dose the lead 
group (positive control) with one size No. 4 pellet of lead shot. Dose 
one group (8 males and 8 females) with eight size No. 4 pellets of 
steel shot (negative control) and dose the 3 other groups (8 males and 
8 females/group) with one, four and eight size No. 4 pellets of 
candidate shot or coated shot.
    (ii) Weigh and fluoroscope birds weekly. Weigh all recovered shot 
to measure erosion. Determine blood parameters given in the 30-day 
acute toxicity test. Provide body weight and blood parameter 
measurements on samples drawn at 24 hours after dosage and at the end 
of days 30 and 60. At the end of 60 days, sacrifice all survivors. 
Remove the liver and other appropriate organs from sacrificed birds and 
birds dying prior to sacrifice on day 60 for histopathological 
analysis. Analyze organs for lead and other metals potentially 
contained in the candidate shot or shot coating. Necropsy all birds 
that died prior to sacrifice to determine pathological conditions 
associated with death.
    (3) Typical test analyses. Analyze mortality among the specified 
groups with appropriate chi-square statistical procedures. Any effects 
on the previously mentioned physiological parameters caused by the shot 
or shot coating must be significantly less than those caused by lead 
shot and must not be significantly greater than those caused by steel 
shot. Analyze physiological data and tissue contaminant data by 
analysis of variance or appropriate statistical procedures to include 
the factors of shot type, dose and sex. Compare sacrificed birds and 
birds that died prior to sacrifice whenever sample sizes are adequate 
for a meaningful comparison.
    (B) Chronic Dosage Study--Tier 3 (Moderately long-term study that 
includes reproductive assessment). Conduct chronic exposure 
reproduction trial with the general guidelines described as follows 
unless otherwise provided by the Service:
    (1) Typical test materials: 44 male and 44 female hand-reared first 
year mallards (Mallards must have plumage and body conformation that 
resemble wild mallards); Pens suitable for quarantine and acclimation 
and for reasonably holding 5-10 ducks each; 44 elevated, pens equipped 
with feeders, waterers and nest boxes; Laboratory equipped to perform 
fluoroscopy, required blood and tissue assays, and necropsies; Whole 
kernel corn, and commercial duck maintenance and breeder mash; and 
Lead, steel and candidate shot or coated shot.
    (2) Typical test procedures. (i) Randomly assign mallards to 3 
groups (Lead group = 4 males and 4 females; steel group = 20 males and 
20 females; candidate shot/coated shot group = 20 males and 20 females) 
in December and hold in same-sex groups until mid-January (dates apply 
to outdoor test facility only and will reflect where in the U.S. tests 
are conducted). Tests conducted in the southern U.S. will need to be 
completed in low temperature units. After a 3-week acclimation period 
with ducks receiving commercial maintenance mash, provide birds with an 
ad libitum diet of corn for 60 days and then pair birds (one pair/pen) 
and provide commercial breeder mash. Dosing of the 3 groups with one 
pellet of No. 4 lead shot (positive control); eight pellets of No. 4 
steel shot (negative control); and eight pellets of No. 4 candidate 
shot or coated shot will occur after the acclimation period (day 0) and 
redosed after 30, 60, and 90 days. Few, if any, of the lead-dosed birds 
(positive control) should survive and reproduce.
    (ii) Fluoroscope birds 1 week after dosage to check for shot 
retention. Weigh males and females the day of initial dosing (day 0), 
at each subsequent dosing, and at death. Measure blood parameters 
identified in the 30-Day Acute Toxicity Test in this test using samples 
drawn at time of weighing. Note the date of first egg and the mean 
number of days per egg laid. Conclude laying after 21 normal, uncracked 
eggs are laid or after 150 days. Sacrifice adults after completion of 
laying period. Remove the liver and other appropriate organs from 
sacrificed birds and from other birds that died prior to sacrifice for 
histopathological analysis. Analyze organs and the 11th egg for 
compounds contained in the shot or shot coating. Necropsy all birds to 
determine any pathological conditions. Check nests daily to collect 
eggs. Discard any eggs laid before pairing. Artificially incubate eggs 
and calculate the percent shell thickness, percent eggs cracked, 
percent fertility (as determined by candling), and percent hatch of 
fertile eggs for each female. Provide ducklings with starter mash after 
hatching. Sacrifice all ducklings at 14 days of age. Measure survival 
to day 14 and weight of the

[[Page 63615]]

ducklings at hatching and sacrifice. Measure blood parameters 
identified in the 30-Day Acute Toxicity Test using samples drawn at 
sacrificing.
    (3) Typical test analyses.
    (i) Any mortality, reproductive inhibition or effects on the 
physiological parameters in paragraph (b)(4) by the shot or shot 
coating must not be significantly greater than those caused by steel 
shot. Percentage data is subject to an arcsine, square root 
transformation prior to statistical analyses. Physiological and 
reproductive data is analyzed by one-tailed t-tests (=0.05), 
or other appropriate statistical procedures by the applicant.
    (ii) After conclusion of Tier 3 testing, the applicant must report 
the results to the Director. If after review of the Tier 3 data 
(completion 60 days after receipt of material) the Service determines 
that all of the information gathered and submitted in accordance with 
Tiers 1, 2, and 3, as applicable, does not establish that the shot or 
shot coating does not impose a significant danger to migratory birds, 
other wildlife, and their habitats, the applicant will have the option 
of repeating the tests that the Director deems are inconclusive. If the 
applicant chooses not to repeat the tests, approval of the candidate 
shot or shot coating is denied. A Notice of Review will inform the 
public that Tier 3 results are inconclusive, the applicant's decision 
not to repeat Tier 3 testing, and the Service's subsequent denial of 
the shot or shot coating.
    (iii) If review of either the initial or repeated Tier 3 test data 
results in a preliminary determination that the shot or shot coating 
does not impose a significant danger to migratory birds, other wildlife 
and their habitats, the Director will publish in the Federal Register a 
proposed rule stating the Service's intention to approve this shot or 
shot coating and providing the public with the opportunity to comment. 
The rulemaking will include a description of the chemical composition 
of the shot or shot coating and a synopsis of findings under the 
standards required by Tier 3. If at the end of the comment period, the 
Service concludes that the shot or shot coating does not impose a 
significant danger to migratory birds, other wildlife, or their 
habitats, the shot or shot coating will be approved as nontoxic with 
publication of a final rule in the Federal Register.
    (5) Residual lead levels. The Service's maximum environmentally 
acceptable level of lead in shot is trace amounts or <1 percent. Any 
shot manufactured with lead levels equal to or exceeding 1 percent are 
considered toxic and, therefore, illegal.
    (6) Field Detection Device. Before approval of any shot for use in 
migratory game bird hunting, a noninvasive field testing device must be 
available for enforcement officers to determine the shot material in a 
given shell in the field.

    Dated: November 3, 1997.
Donald J. Barry,
Acting Assistant Secretary for Fish and Wildlife and Parks.
[FR Doc. 97-31328 Filed 11-28-97; 8:45 am]
BILLING CODE 4310-55-P