[Federal Register Volume 78, Number 42 (Monday, March 4, 2013)]
[Proposed Rules]
[Pages 14060-14069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04906]


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DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

50 CFR Part 20

[Docket No. FWS-R9-MB-2011-0077; FF09M21200-134-FXMB1231099BPP0]
RIN 1018-AY59


Migratory Bird Hunting; Revision of Language for Approval of 
Nontoxic Shot for Use in Waterfowl Hunting

AGENCY: Fish and Wildlife Service, Interior.

ACTION: Proposed rule.

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SUMMARY: We, the U.S. Fish and Wildlife Service, propose to revise our 
regulations regarding the approval of nontoxic shot types to make the 
regulations easier to understand. The language governing determination 
of Expected Environmental Concentrations (EECs) in terrestrial and 
aquatic ecosystems is altered to make clear the shot size and number of 
shot to be used in calculating the EECs. We propose to specify the pH 
levels to be used in calculating the EEC in water. We also propose to 
move the requirement for in vitro testing to Tier 1, which will allow 
us to better assess applications and minimize the need for Tier 2 
applications. We propose to add language for withdrawal of alloys that 
have been demonstrated to have detrimental environmental or biological 
effects, or for which no suitable field-testing device is available. We 
expect these changes to reduce the time

[[Page 14061]]

required for nontoxic shot approvals. Finally, we propose to charge 
fees to cover our costs in evaluating these applications.

DATES: Electronic comments on this proposal via http://www.regulations.gov must be submitted by 11:59 p.m. Eastern time on 
June 3, 2013. Comments submitted by mail must be postmarked no later 
than June 3, 2013. Comments on the information collection requirements 
are due no later than April 3, 2013.

ADDRESSES: You may submit comments by either of the following two 
methods:
     Federal eRulemaking portal: http://www.regulations.gov. 
Follow the instructions for submitting comments on Docket No. FWS-R9-
MB-2011-0077.
     U.S. mail or hand delivery: Public Comments Processing, 
Attention: FWS-R9-MB-2011-0077; Division of Policy and Directives 
Management; U.S. Fish and Wildlife Service; 4401 North Fairfax Drive, 
MS 2042-PDM; Arlington, VA 22203-1610.
    We will not accept email or faxes. We will post all comments on 
http://www.regulations.gov. This generally means that we will post any 
personal information that you provide. See the Public Comments section 
below for more information.
    Submit comments on the information collection requirements to the 
Desk Officer for the Department of the Interior at Office of Management 
and Budget, Office of Information and Regulatory Affairs (OMB-OIRA) at 
(202) 395-5806 (fax) or [email protected] (email). Please 
provide a copy of your comments to the Service Information Collection 
Clearance Officer, U.S. Fish and Wildlife Service, MS 2042-PDM, 4401 
North Fairfax Drive, Arlington, VA 22203 (mail), or [email protected] 
(email).

FOR FURTHER INFORMATION CONTACT: Dr. George Allen, 703-358-1825.

SUPPLEMENTARY INFORMATION: 

Background

    The Migratory Bird Treaty Act of 1918 (Act) (16 U.S.C. 703-712 and 
16 U.S.C. 742 a-j) implements migratory bird treaties between the 
United States and Great Britain for Canada (1916 and 1996 as amended), 
Mexico (1936 and 1972 as amended), Japan (1972 and 1974 as amended), 
and Russia (then the Soviet Union, 1978). These treaties protect 
certain migratory birds from take, except as permitted under the Act. 
The Act authorizes the Secretary of the Interior to regulate take of 
migratory birds in the United States. Under this authority, the U.S. 
Fish and Wildlife Service (FWS) regulates the hunting of migratory game 
birds through regulations in 50 CFR part 20.
    Since the mid-1970s, we have sought to identify shot types that are 
not significant toxicity hazards to migratory birds or other wildlife. 
Producers of potential nontoxic shot alloys submit them for FWS 
approval under 50 CFR 20.134 as nontoxic for waterfowl hunting. We 
propose to revise the regulations to clarify them for applicants and to 
provide for withdrawal of approval of a shot type that is not readily 
detectable in the field or has environmental effects or direct 
toxicological effects on biota.

Changes in the Regulations Governing Nontoxic Shot Approval

    We propose to rewrite the regulations at 50 CFR 20.134 in plain 
language and to change or add some provisions. We seek comment on these 
proposed regulations, particularly the following proposed changes:
    1. Eliminating publication of a Notice of Application in the 
Federal Register upon receipt of an application for approval (current 
paragraph (b)(2)(i)(D)(3)). We have found that these notices engender 
few comments, and the public has a meaningful opportunity to 
participate later in the approval process.
    2. Specifying that an application for approval of a nontoxic alloy 
must document that a shotshell loaded with shot of the alloy can be 
readily identified as containing nontoxic shot with a standard field 
shotshell testing device (proposed paragraph (b)(2)). Wildlife law 
enforcement officers should be able to use simple, readily available 
testing devices for nontoxic shotshells. Applicants have consistently 
provided this information, and this requirement is a negligible 
addition to their costs.
    3. Specifying that an application for approval of a nontoxic shot 
must include a statement of the relative hardness of the candidate 
alloy, compared to standard lead shot having a hardness of 1.0. This 
information will help the public decide about the type of firearm in 
which the shot type can safely be used (proposed paragraph (e)(4)). 
Providing this information will not add significantly to the 
application preparation time or cost.
    4. Revising language governing the determination of Expected 
Environmental Concentrations (EECs) in terrestrial and aquatic 
ecosystems to make clear the shot size and number of shot to be used in 
calculating the EECs (proposed paragraph (g)(3)). This information is 
not in the current regulations. This addition will reduce the 
application preparation time and cost because applicants have 
previously had to contact us about this point.
    5. Adding specific pH levels to be used in calculating the EEC in 
water (proposed paragraph (g)(3)(ii)). This information is not in the 
current regulations. Specifying the pH will reduce the application 
preparation time and cost because applicants have previously had to 
contact us about this point.
    6. Moving the former Tier 2 solubility testing to Tier 1 (proposed 
paragraph (h)). This change will allow us to better assess applications 
and minimize the need for Tier 2 applications. We expect it to reduce 
the time required for nontoxic shot approvals. This change will add to 
applicants' initial costs, but will speed up application reviews and 
will help us to avoid requiring Tier 2 testing for some applications. 
We estimate that applicants will incur an additional cost of $25,000 to 
complete the solubility testing.
    7. Adding a provision for withdrawal of an approved shot type 
(proposed paragraph (z)). There is no provision in the current 
regulations for withdrawal of the approval of a shot type. For example, 
changes in manufacturing can render a shot type nonmagnetic despite its 
containing an amount of iron normally sufficient to be detectable in a 
loaded shotshell with a magnet. These loaded shells are then not 
identifiable by the method we approved when approving the shot type for 
use in hunting, and perhaps not by any field-testing method.

Permit Application Processing Fee

    We propose to charge a fee sufficient to offset the estimated costs 
associated with processing and our periodic review of these permits. 
Revised OMB circular A-25 directs Executive Branch agencies to recover 
costs, stating that, ``When a service (or privilege) provides special 
benefits to an identifiable recipient beyond those that accrue to the 
general public, a charge will be imposed (to recover the full cost to 
the Federal Government for providing the special benefit, or the market 
price).'' Further, Circular A-25 directs that, ``Except as provided in 
Section 6c, user charges will be sufficient to recover the full cost to 
the Federal Government (as defined in Section 6d) of providing the 
service, resource, or good when the Government is acting in its 
capacity as sovereign.'' Thus, the directive to the Service is to 
recover the costs for working with applicants and assessing nontoxic 
shot approval applications.

[[Page 14062]]

    We have received less than one application per year, on average, 
for approval of a new nontoxic shot type per year in the last decade. 
However, each application requires staff review time, preparation of an 
environmental assessment to comply with the National Environmental 
Policy Act, consultation with toxicologists about the shot alloy(s), 
and three Federal Register publications, though we propose in this rule 
to reduce that to one standard proposed rule and a final rule.
    Having considered the agency costs and the requirement to recoup 
those costs, we propose a Tier 1 nontoxic shot application fee of $800. 
That amount is $53 more than our estimated current review costs 
reflected in table 1, but is below the Service's costs in the near 
future. Likewise, we propose an additional $700 fee for evaluation of a 
Tier 2 application, if one is needed, and $700 more for evaluation of a 
Tier 3 application, if one is needed (based on current costs of $664 
for each of these reviews, as shown in table 1). If the application is 
approved, then the applicant would incur an additional fee of $20,000 
to cover costs for additional administrative review and Federal 
Register publication of the required proposed and final rule.

              Table 1--Current Hours and Costs for Processing a Nontoxic Shot Approval Application
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                                                                                    Approximate
                              Task                                  Staff hours        cost         Review cost
----------------------------------------------------------------------------------------------------------------
Tier 1..........................................................................................................
----------------------------------------------------------------------------------------------------------------
Review application for completeness.............................               2        \1\ $166            $747
Review by U.S. Geological Survey toxicologist...................               5             415
Consult with U.S. Geological Survey toxicologist................               2             166
----------------------------------------------------------------------------------------------------------------
Tier 2..........................................................................................................
----------------------------------------------------------------------------------------------------------------
Review of Tier 2 application....................................               3             249             664
Review of Tier 2 application by USGS toxicologist...............               5             415
----------------------------------------------------------------------------------------------------------------
Tier 3..........................................................................................................
----------------------------------------------------------------------------------------------------------------
Review of Tier 3 application....................................               3             249             664
Review of Tier 3 application by USGS toxicologist...............               5             415
----------------------------------------------------------------------------------------------------------------
Publication Fees (if application is approved)...................................................................
----------------------------------------------------------------------------------------------------------------
Prepare draft environmental assessment and proposed rule........              20           1,660          19,575
Proposed rule Federal Register charges..........................  ..............      \2\ 11,000
Review comments and prepare final environmental assessment and                 5             415
 final rule.....................................................
Final rule Federal Register charges.............................  ..............       \3\ 6,500
                                                                 -----------------------------------------------
    Total.......................................................  ..............          21,650
----------------------------------------------------------------------------------------------------------------
\1\ Staff review costs are based on Washington, D.C. metro area salary and benefits for a GS13/10 biologist
  ($55.46/hour * 1.5 for benefits, or about $83/hour).
\2\ Average publication cost of nontoxic shot proposed rules from 2001 through 2011 was $10,695.
\3\ Average publication cost of nontoxic shot final rules from 2001 through 2011 was $6,122.50.

Public Comments

    We request comments or suggestions on this proposed rule from any 
interested parties. You may submit comments and materials concerning 
this proposed rule by either one of the methods listed in ADDRESSES. We 
will not consider comments sent by email or fax or to an address not 
listed in ADDRESSES. Please do not submit comments by both 
alternatives.
    If you submit a comment via http://www.regulations.gov, your entire 
comment--including any personal identifying information--will be posted 
on the Web site. If you submit a hardcopy comment that includes 
personal identifying information, you may request at the top of your 
document that we withhold this information from public review. However, 
we cannot guarantee that we will be able to do so. We will post all 
hardcopy comments on http://www.regulations.gov.
    Comments and materials we receive, as well as supporting 
documentation we used in preparing this proposed rule, will be 
available for public inspection at http://www.regulations.gov, or by 
appointment at the U.S. Fish and Wildlife Service (see FOR FURTHER 
INFORMATION CONTACT). You may obtain copies of our previous actions 
concerning this subject by mail (see FOR FURTHER INFORMATION CONTACT) 
or by visiting the Federal eRulemaking Portal at http://www.regulations.gov.

Required Determinations

Regulatory Planning and Review (Executive Orders 12866 and 13563)

    Executive Order 12866 provides that the Office of Information and 
Regulatory Affairs (OIRA) will review all significant rules. OIRA has 
determined that this rule is not significant.
    Executive Order 13563 reaffirms the principles of E.O. 12866 while 
calling for improvements in the nation's regulatory system to promote 
predictability, to reduce uncertainty, and to use the best, most 
innovative, and least burdensome tools for achieving regulatory ends. 
Executive Order 13563 directs agencies to consider regulatory 
approaches that reduce burdens and maintain flexibility and freedom of 
choice for the public where these approaches are relevant, feasible, 
and consistent with regulatory objectives. E.O. 13563 emphasizes 
further that regulations must be based on the best available science 
and that the rulemaking process must allow for public participation and 
an open exchange of ideas. We have developed this rule in a manner 
consistent with these requirements.

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

    Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq., as 
amended by the Small Business Regulatory Enforcement

[[Page 14063]]

Fairness Act (SBREFA) of 1996), whenever an agency is required to 
publish a notice of rulemaking for any proposed or final rule, it must 
prepare and make available for public comment a regulatory flexibility 
analysis that describes the effect of the proposed rule on small 
businesses, small organizations, and small government jurisdictions. 
However, no regulatory flexibility analysis is required if the head of 
an agency certifies that the proposed rule will not have a significant 
economic impact on a substantial number of small entities. Thus, for a 
regulatory flexibility analysis to be required, impacts must exceed a 
threshold for ``significant impact'' and a threshold for a 
``substantial number of small entities.'' See 5 U.S.C. 605(b). SBREFA 
amended the Regulatory Flexibility Act to require Federal agencies to 
provide a statement of the factual basis for certifying that a rule 
would not have a significant economic impact on a substantial number of 
small entities.
    The proposed rule would require additional information in the 
initial application and increase the application fee. As a result, 
companies applying for nontoxic shot approval would incur additional 
costs. These companies include ammunition companies. The U.S. Small 
Business Administration defines a ``small business'' as one with 
employment that meets or is below the established size standard, which 
is 1,000 employees for ``Small Arms Ammunition Manufacturing'' 
businesses (NAICS 332992). In 2010, the U.S. Census Bureau shows that 
about 93 percent of the 112 Small Arms Ammunition Manufacturing 
establishments qualify as small businesses (fewer than 1,000 
employees). We receive an average of only about one application per 
year, so less than one percent of affected small businesses would be 
impacted.
    The proposed rule would have minimal impact on the application 
process for nontoxic shot. Applicants already submit the additional 
application information that the regulations will require. Therefore, 
the information in an application would change minimally.
    The proposed rule includes application fees because, as detailed in 
the preamble, revised OMB circular A-25 directs Executive Branch 
agencies to establish ``user charges * * * sufficient to recover the 
full cost to the Federal Government.'' A large portion of the 
application costs consist of Federal Register publication fees 
($17,500, as reflected in table 1). Because we are required to publish 
each approved nontoxic shot application in the Federal Register, we are 
proposing to recoup publication fees from each company that applies for 
a nontoxic shot approval.
    We have examined this proposed rule's potential effects on small 
entities, and have determined that it will not have a significant 
economic impact on a substantial number of small entities because less 
than one percent of small businesses would be impacted. Therefore, we 
certify that this proposed rule will not have a significant economic 
effect on a substantial number of small entities as defined under the 
Regulatory Flexibility Act (5 U.S.C. 601 et seq.). An initial/final 
Regulatory Flexibility Analysis is not required. Accordingly, a Small 
Entity Compliance Guide is not required.

Small Business Regulatory Enforcement Fairness Act

    This proposed rule is not a major rule under 5 U.S.C. 804(2), the 
Small Business Regulatory Enforcement Fairness Act.
    a. This proposed rule does not have an annual effect on the economy 
of $100 million or more. It will not change the costs for submission of 
shot types for approval as nontoxic.
    b. This proposed rule will not cause a major increase in costs or 
prices for consumers, individual industries, Federal, State, or local 
government agencies, or geographic regions.
    c. This proposed rule will not have significant adverse effects on 
competition, employment, investment, productivity, innovation, or the 
ability of U.S.-based enterprises to compete with foreign-based 
enterprises.

Unfunded Mandates Reform Act

    In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 
et seq.), we have determined the following:
    a. This proposed rule will not ``significantly or uniquely'' affect 
small governments. A Small Government Agency Plan is not required. 
Regulation of nontoxic shot for migratory bird hunting does not affect 
small government activities.
    b. This proposed rule will not produce a Federal mandate of $100 
million or greater in any year, so it is not a ``significant regulatory 
action'' under the Unfunded Mandates Reform Act. The proposed 
regulation revision will not significantly affect State regulations.

Takings

    This proposed rule does not affect private property, and has no 
takings implications. In accordance with Executive Order 12630, a 
takings implication assessment is not required.

Federalism

    This proposed rule does not have sufficient Federalism effects to 
warrant preparation of a Federalism assessment under Executive Order 
13132. It will not interfere with the States' abilities to manage 
themselves or their funds. No significant economic impacts should 
result because of these proposed changes to the regulation of nontoxic 
shot approval.

Civil Justice Reform

    In accordance with Executive Order 12988, the Office of the 
Solicitor has determined that the proposed rule does not unduly burden 
the judicial system and meets the requirements of sections 3(a) and 
3(b)(2) of the Order.

Paperwork Reduction Act

    This proposed rule contains a collection of information that we are 
submitting to the Office of Management and Budget (OMB) for review and 
approval under Sec. 3507(d) of the Paperwork Reduction Act (PRA). OMB 
has reviewed and approved the current information collection 
requirements associated with the approval of nontoxic shot for use in 
waterfowl hunting and assigned OMB Control Number 1018-0067, which 
expires May 31, 2015. An agency may not conduct or sponsor and you are 
not required to respond to a collection of information unless it 
displays a currently valid OMB control number.
    We propose to revise the regulations at 50 CFR 20.134 to add the 
following new requirements:
     Application must document that a shotshell loaded with 
shot of the alloy can be readily identified as containing nontoxic shot 
with a standard field shotshell testing device. Wildlife law 
enforcement officers should be able to use simple, readily available 
testing devices for nontoxic shotshells.
     Application must include a statement of the relative 
hardness of the candidate alloy, compared to standard lead shot having 
a hardness of 1.0. This information will help the public decide about 
the type of firearm in which the shot type can be used safely.
     Required shot size and number of shot to be used in 
calculating the Expected Environmental Concentrations (EECs) in 
terrestrial and aquatic ecosystems.
     Specific pH levels to be used in calculating the EEC in 
water.
    We expect that the above requirements will add very little to the 
application preparation time or cost;

[[Page 14064]]

therefore, we have not increased the completion time from that 
currently approved. In addition to the above requirements, we are also 
proposing to move the former Tier 2 solubility testing to Tier 1. This 
change will allow us to better assess applications and minimize the 
need for Tier 2 applications.
    We are also proposing fees for different stages of an application 
sufficient to offset the estimated costs associated with processing the 
application. See Permit Application Processing Fee, above, for an 
explanation of this fee. We have increased our estimate of the nonhour 
burden cost by including the $800 application fee for Tier 1 
applications.
    Title: Approval Procedures for Nontoxic Shot and Shot Coatings, 50 
CFR 20.134.
    OMB Control Number: 1018-0067.
    Service Form Number: None.
    Type of Request: Revision of a currently approved collection.
    Description of Respondents: Businesses that produce and/or market 
approved nontoxic shot types or nontoxic shot coatings.
    Respondent's Obligation: Required to obtain or retain a benefit.
    Frequency of Collection: On occasion.
    Estimated Number of Respondents: 1.
    Estimated Number of Annual Responses: 1.
    Estimated Completion Time per Response: 3,200 hours.
    Estimated Total Annual Burden Hours: 3,200.
    Estimated Total Nonhour Burden Cost: $25,800 ($800 for application 
processing fees, plus $25,000 for solubility testing).
    As part of our continuing effort to reduce paperwork and respondent 
burdens, we invite the public and other Federal agencies to comment on 
any aspect of the reporting burden, including:
    (1) Whether or not the collection of information is necessary, 
including whether or not the information will have practical utility;
    (2) The accuracy of our estimate of the burden for this collection 
of information;
    (3) Ways to enhance the quality, utility, and clarity of the 
information to be collected; and
    (4) Ways to minimize the burden of the collection of information on 
respondents.
    Send your comments and suggestions on this information collection 
to the Desk Officer for the Department of the Interior at OMB-OIRA at 
(202) 395-5806 (fax) or [email protected] (email). Please 
provide a copy of your comments to the Service Information Collection 
Clearance Officer, U.S. Fish and Wildlife Service, MS 2042-PDM, 4401 
North Fairfax Drive, Arlington, VA 22203 (mail), or [email protected] 
(email).

National Environmental Policy Act

    We have analyzed this proposed rule in accordance with the criteria 
of the National Environmental Policy Act and 516 DM. This proposed rule 
does not constitute a major Federal action significantly affecting the 
quality of the human environment, and does not require the preparation 
of an environmental impact statement or an environmental assessment. 
The changes we propose are largely to reorganize the regulations and 
put them into easier-to-understand language. Because the revision of 50 
CFR 20.134 is administrative, it will have no environmental effects. It 
is categorically excluded from further NEPA requirements (43 CFR 
46.210(i)).

Environmental Consequences of the Proposed Action

    The changes we propose are primarily in the reorganizing and 
rewriting of the regulations. The environmental impacts of this action 
are minimal.
    Socio-economic. We do not expect the proposed regulations change to 
have any socio-economic impacts.
    Wildlife populations. This proposed regulations change does not 
significantly alter the approval of nontoxic shot in the United States. 
This proposed rule will have no effects on wildlife populations.
    Endangered and Threatened Species. The proposed regulations change 
will have no effect on the status of threatened or endangered species.

Government-to-Government Relationship With Tribes

    In accordance with the President's memorandum of April 29, 1994, 
``Government-to-Government Relations with Native American Tribal 
Governments'' (59 FR 22951), Executive Order 13175, and 512 DM 2, we 
have determined that there are no potential effects on federally 
recognized Indian tribes. This proposed rule will not interfere with 
Tribes' abilities to manage themselves or their funds or to regulate 
migratory bird hunting on tribal lands.

Energy Supply, Distribution or Use

    Executive Order 13211 requires agencies to prepare Statements of 
Energy Effects when undertaking certain actions. This proposed rule 
will not affect energy supplies, distribution, or use, so it does not 
require a Statement of Energy Effects.

Compliance With Endangered Species Act Requirements

    Section 7 of the Endangered Species Act (ESA) of 1973, as amended 
(16 U.S.C. 1531 et seq.), requires that ``The Secretary [of the 
Interior] shall review other programs administered by him and utilize 
such programs in furtherance of the purposes of this chapter'' (16 
U.S.C. 1536(a)(1)). It further states that the Secretary must ``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'' (16 U.S.C. 1536(a)(2)). The proposed 
regulations change would not affect listed species.

Clarity of This Regulation

    We are required by Executive Orders 12866 and 12988 and by the 
Presidential Memorandum of June 1, 1998, to write all rules in plain 
language. This means that each rule we publish must:
    (a) Be logically organized;
    (b) Use the active voice to address readers directly;
    (c) Use clear language rather than jargon;
    (d) Be divided into short sections and sentences; and
    (e) Use lists and tables wherever possible.
    If you feel that we have not met these requirements, send us 
comments by one of the methods listed in the ADDRESSES section. To 
better help us revise the rule, your comments should be as specific as 
possible. For example, you should tell us the numbers of the sections 
or paragraphs that are not clearly written, which sections or sentences 
are too long, the sections where you feel lists or tables would be 
useful, etc.

List of Subjects in 50 CFR Part 20

    Exports, Hunting, Imports, Reporting and recordkeeping 
requirements, Transportation, Wildlife.

    For the reasons discussed in the preamble, we propose to amend part 
20, subchapter B, chapter I of title 50 of the Code of Federal 
Regulations as set forth below.

PART 20--[AMENDED]

0
1. The authority citation for part 20 is revised to read as follows:

    Authority:  16 U.S.C. 703-712 and 742 a-j; Pub. L. 106-108.


[[Page 14065]]


0
2. Revise Sec.  20.134, including the section heading, to read as 
follows:


Sec.  20.134  Approval of nontoxic shot alloys and coatings.

    The U.S. Fish and Wildlife Service conducts a process to approve 
shot material determined not to impose a significant toxicity danger to 
migratory birds and other wildlife or their habitats. The regulations 
in this section set forth the approval process. Upon receipt of an 
application and supporting data submitted in accordance with this 
section, the Service will review the application materials together 
with all other relevant available evidence, including public comment. 
If the Director concludes that the spent shot material will not present 
a significant toxicity danger to migratory birds and other wildlife or 
their habitats, we will add the shot material to the list of approved 
nontoxic shot materials at 50 CFR 20.21(j).
    (a) Information collection approval. The Office of Management and 
Budget approved the information collection requirements contained in 
this section under 44 U.S.C. 3501 et seq. and assigned OMB Control No. 
1018-0067. We collect this information so that we can conduct a 
methodical and objective review of an alloy you submit as nontoxic for 
hunting waterfowl. An agency may not conduct or sponsor and you are not 
required to respond to a collection of information unless it displays a 
currently valid OMB control number. You may submit comments on this 
information collection to the Service Information Collection Officer, 
U.S. Fish and Wildlife Service, 1849 C Street NW., Mailstop 2042-PDM, 
Washington, DC 20240.
    (b) Limitations on nontoxic alloy approval. We will not approve as 
nontoxic any alloy or shot coating with a lead content of 1 percent or 
more.
    (1) Before we will approve any alloy or shot coating as nontoxic, a 
shotshell loaded with the alloy or coated shot must be demonstrated to 
be identifiable as not being lead in a portable field testing device 
used by enforcement officers.
    (2) The testing device can be regular magnets, rare-earth magnets, 
or the ``HOT*SHOT'' field-testing device from Stream Systems of 
Concord, CA. We will consider other field-testing devices that may be 
readily available to law enforcement officers.
    (c) Application submission and review. We use a 3-tier strategy for 
approval of nontoxic alloys and shot coatings. You must submit any 
application for approval under this section with supporting 
documentation in accordance with the following procedures and must 
include at least the supporting materials and information for Tier 1 in 
the approval system. If your application is not complete, we will 
return it to you with an explanation of the additional information we 
need to initiate review of your submission.
    (d) Tier 1 application fee. The fee for consideration of a Tier 1 
application is $800. Submit the fee, payable to the U.S. Fish and 
Wildlife Service, with your application.
    (e) Tier 1 application. If you wish to submit an alloy or shot 
coating for consideration as nontoxic for waterfowl hunting, you must 
provide statements of use, chemical characterization, production 
variability, volume of use of the candidate material, and a sample of 
the shot or shot coating.
    (1) Provide a statement of how you propose to use the candidate 
material in creating waterfowl hunting shotshells.
    (2) Provide a description of the chemical composition of the 
material comprising the shot.
    (i) Provide the chemical names, Chemical Abstracts Service numbers 
(consult the American Chemical Society), and structures of the 
components of the shot.
    (ii) Provide a chemical characterization for organics and 
organometallics for the core and/or coating, including the empirical 
formula, melting point, molecular weight, solubility, specific gravity, 
partition coefficients, hydrolysis half-life, leaching rate in water 
and in soil, degradation half-life, vapor pressure, stability, and 
other relevant characteristics for each component.
    (iii) Provide data on the composition, weight, and sectional 
density of the shot material.
    (iv) Provide data on the thickness, quantity in milligrams (mg) per 
shot, and chemical composition of any coating on the shot.
    (3) Provide documentation that the shot can be readily identified 
as nontoxic with a standard field shotshell testing device.
    (4) Provide a statement of the relative hardness of the candidate 
alloy, compared to standard lead shot having a hardness of 1.0.
    (5) Provide a statement of the expected variability of shot during 
production.
    (6) Provide an estimate of yearly volume of candidate alloy and/or 
coated shot expected to be produced for use in hunting migratory birds 
in the United States.
    (7) Provide 5 pounds (approximately 2.18 kilograms (kg)) of the 
candidate alloy or shot with the proposed coating in size equivalent to 
U.S. standard size No. 4 of 0.13 inches (approximately 3.3 millimeters 
(mm)) in diameter.
    (i) We or an independent laboratory may analyze the composition of 
the shot or the shot coating.
    (ii) We will reject your application if the composition of the shot 
or shot coating differs substantially from what you describe in your 
application.
    (f) Toxicological effects. You must provide information on the 
toxicological effects of the shot or any coating on it.
    (1) Provide a summary of the acute and chronic toxicity data of the 
metals or compounds in the shot or the shot coating, ranking the 
toxicity of each. Use the following criteria to assess the toxicity of 
the shot or shot coating. These criteria are based on the estimated 
median lethal dose of the candidate alloy or shot coating. That is, the 
statistically derived single dose estimate of the candidate material 
that can be expected to cause death in 50 percent of the animals tested 
(LD50).

------------------------------------------------------------------------
        If the LD50 is                 the material is considered
------------------------------------------------------------------------
no more than 5 mg/kg,          super toxic.
over 5 to 50 mg/kg,            extremely toxic.
over 50 to 500 mg/kg,          very toxic.
over 500 to 5,000 mg/kg,       moderately toxic.
over 5,000 to 15,000 mg/kg,    slightly toxic.
over 15,000 mg/kg,             nontoxic.
------------------------------------------------------------------------

     (2) Provide 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 
(concentrations in water lethal to 50 percent of test populations) 
data, and sublethal effects, with citations.
    (3) Provide 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 the toxic effect, such as mortality, impaired reproduction, 
substantial weight loss, disorientation, or other relevant associated 
clinical observations.
    (4) Provide a statement with supporting rationale and citations to 
relevant data about whether ingestion of the shot or shot coating by 
fish, amphibians, reptiles, or mammals is cause for concern. If there 
is a recognized impact on fish, amphibians, reptiles, or mammals, we 
reserve the right to require additional study of the shot or shot 
coating.
    (g) Environmental fate and transport. You must provide information 
on the

[[Page 14066]]

environmental fate and transport, if any, of the shot and any coating 
on it.
    (1) Provide a statement describing any chemical or physical 
alteration of the shot and shot coating upon firing.
    (2) Provide an estimate of the environmental half-life of the 
organic or organometallic components of the shot and shot coating, and 
a description of the chemical form of the breakdown products of the 
component(s).
    (3) For each metal or other component of the shot or shot coating, 
determine the Estimated Environmental Concentration (EEC).
    (i) Determine the EEC in a terrestrial ecosystem if 69,000 U.S. 
standard size No. 4 shot of 0.13 in (3.3 mm) in diameter are completely 
dissolved in 1 hectare (ha) (107,639 square feet (ft\2\)) of soil 5 
centimeters (cm) (1.97 in) deep. Assess whether the EEC would exceed 
the clean soil standards for the Use or Disposal of Sewage Sludge at 40 
CFR part 503. Explain how the estimated EEC relates to the toxicity 
thresholds for plants, invertebrates, fish, and wildlife.
    (ii) Determine the EEC in an aquatic ecosystem if 69,000 U.S. 
standard size No. 4 shot of 0.13 in (3.3 mm) in diameter are completely 
dissolved in 1 ha, or 107,639 ft\2\, of water 1 ft (30.48 cm) deep. 
Express the calculated concentrations in standard units such as 
micrograms per liter, for water with pH of 4.0, 7.0, and 9.0. Explain 
how the estimated EEC compares to the U.S. Environmental Protection 
Agency (EPA) Water Quality Criteria and toxicity thresholds in plants, 
invertebrates, fish, and wildlife.
    (4) Conduct a risk assessment using the Quotient Method. Calculate 
the risk of the submitted shot material, the EEC/the Toxicological 
Level of Concern. For example, compare the EEC in parts per million (p/
m) to an effect level such as the LD50 in p/m. Use the following 
criteria to assess the risk of the components of the shot or shot 
coating.

------------------------------------------------------------------------
          If the risk ratio is                         then
------------------------------------------------------------------------
less than 0.1,                           adverse effects are not likely.
0.1 to 10.0,                             adverse effects are possible.
greater than 10.0,                       adverse effects are likely.
------------------------------------------------------------------------

     (h) In vitro evaluation. You must evaluate the candidate alloy or 
shot coating in a standardized test under conditions that will assess 
its erosion and any release of components into a liquid medium in an 
environment simulating the conditions of a waterfowl gizzard. Compare 
the erosion characteristics to those of lead shot and steel shot of 
comparable size.
    (1) Test materials. You will need appropriate analysis equipment, 
such as for atomic absorption spectrophotometry or inductively coupled 
plasma mass spectrometry, a drilled aluminum block to support test 
tubes, a thermostatically controlled stirring hot plate, small 
Teflon[supreg]-coated magnets, hydrochloric acid of pH 2.0, pepsin, 
capped test tubes, and U.S. No. 4 lead, steel, and candidate alloy or 
shot with the proposed coating.
    (2) Test procedures.
    (i) Add hydrochloric acid and pepsin to each capped test tube at a 
volume and concentration that will erode a single U.S. No. 4 lead shot 
at the rate of 5 mg per day.
    (ii) Place three test tubes, each containing lead shot, steel shot, 
or the candidate alloy or shot with the proposed coating in an aluminum 
block on the stirring hot plate. Add a Teflon[supreg]-coated magnet to 
each test tube and set the hot plate at 42 degrees Centigrade and 500 
revolutions per minute.
    (iii) Determine the erosion of shot or shot with the proposed 
coating daily for 14 consecutive days by weighing the shot and 
analyzing the digestion solution with an atomic absorption 
spectrophotometer.
    (iv) Replicate the 14-day procedure five times.
    (3) Test analyses. Compare erosion rates of the three types of shot 
by appropriate analysis of variance and regression procedures. The 
statistical analyses will determine whether the rate of erosion of the 
shot and/or shot coating is significantly greater or less than that of 
lead and/or steel shot. This determination is important to any 
subsequent toxicity testing.
    (i) Tier 1 application review. Upon receipt of your completed Tier 
1 application, we will promptly perform an overview. We will notify you 
within 30 days of receipt that our thorough review of the application 
will commence, and we will complete our review within 60 days of the 
date of publication. We will use half of the LD50/ft\2\ in terrestrial 
and aquatic systems as the level of concern in evaluating your 
application.
    (j) Approval after Tier 1 testing. If we determine that the Tier 1 
data show that the shot or shot coating does not pose a significant 
toxicity danger to migratory birds, other wildlife, or their habitats, 
we will notify you and request payment of a $20,000 final review and 
publication fee (payable to the U.S. Fish and Wildlife Service).
    (1) After receipt of payment, we will publish a proposed rule in 
the Federal Register stating that we intend to approve this shot or 
shot coating as nontoxic and provide the public with the opportunity to 
comment on our decision. The proposed rule 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 1.
    (2) If, after considering public comment on the proposed rule, we 
conclude that the shot or shot coating does not pose a significant 
toxicity danger to migratory birds, other wildlife, or their habitats, 
we will approve the shot or coating as nontoxic with publication of a 
final rule in the Federal Register and addition of the shot or coating 
to the list in Sec.  20.21(j).
    (k) Additional testing. If we conclude that the Tier 1 data are 
inconclusive, or if we conclude that the shot or shot coating may pose 
a significant toxicity danger to migratory birds, other wildlife, or 
their habitats, we will advise you to proceed with some or all of the 
additional testing described for Tier 2, Tier 3, or both.
    (1) We will inform you that we consider the Tier 1 test results to 
be inconclusive. We will request Tier 2, and possibly Tier 3, testing 
before we evaluate the shot any further.
    (2) If you choose not to do further testing, we will deny approval 
of the candidate alloy or shot coating.
    (l) Tier 2 application fee. The fee for consideration of a Tier 2 
application is $700. Submit the fee, payable to the U.S. Fish and 
Wildlife Service, with your application.
    (m) Tier 2 testing. Your Tier 2 testing procedures must be in 
compliance with the Good Laboratory Practice Standards (40 CFR part 
160) except where they conflict with the requirements in this section 
or with a provision of an approved plan. We reserve the right for us or 
an authorized representative to inspect your laboratory facilities. We 
will not approve the plan and further consideration of the candidate 
alloy if the laboratory does not meet the Good Laboratory Practice 
Standards.
    (n) Tier 2 plan review. We will review the Tier 2 testing plan you 
submit within 30 days of the day on which we receive it. We may decline 
to approve the plan, or any part of it, if we deem it deficient in any 
manner with regard to timing, format, or content. We will inform you 
regarding what parts, if any, of the submitted testing procedures to 
disregard and any modifications to incorporate into the Tier 2 testing 
plan to gain plan approval. After we accept your plan, you may conduct 
Tier 2 testing.
    (o) Tier 2 in vivo evaluation. Conduct a 30-day acute toxicity test 
in mallards

[[Page 14067]]

using the following method unless we specify otherwise.
    (1) Test materials. You will need 30 male and 30 female hand-reared 
mallards approximately 6 to 8 months old with plumage and body 
conformation of wild mallards; 60 elevated outdoor pens equipped with 
feeders and waterers; a laboratory equipped to perform fluoroscopy, 
required blood and tissue assays, and necropsies; commercial duck 
maintenance mash; and lead, steel, and candidate alloy.
    (2) Test procedures.
    (i) House the mallards individually in pens and give them 
unrestricted access to food and water.
    (ii) After 3 weeks, randomly assign them to 3 groups of 10 males 
and 10 females per group. Dose each duck with eight pellets of either 
U.S. No. 4 lead shot (positive control), steel shot (negative control), 
or the candidate alloy or shot with the proposed coating.
    (iii) Fluoroscope each bird at 1 week after dosing to check for 
shot retention.
    (iv) For 30 days, observe the birds daily for signs of intoxication 
and mortality.
    (v) Determine the body weight for each bird at the time of dosing 
and at days 15 and 30.
    (vi) On days 15 and 30, collect blood by venipuncture and determine 
hematocrit, hemoglobin concentration, and other measures of blood 
chemistry.
    (vii) Euthanize all survivors on day 30. Remove the liver and other 
appropriate organs from each bird and those from birds that died prior 
to day 30.
    (viii) Analyze the organs for lead and compounds contained in the 
candidate alloy or shot with the proposed coating.
    (ix) Perform a necropsy of all birds to determine any pathological 
conditions.
    (3) Test analyses.
    (i) Analyze mortality among the specified groups with appropriate 
statistical procedures, such as chi-square, with [alpha] = 0.05, and 
[beta] = 0.8.
    (ii) Analyze physiological data and tissue contaminant data by 
analysis of variance or other appropriate statistical procedures to 
include the factors of alloy and sex, with [alpha] = 0.05 and [beta] = 
0.8.
    (iii) Compare euthanized birds and birds that died prior to day 30 
whenever sample sizes are adequate for meaningful comparison.
    (p) Daphnia 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 Daphnia (Daphnia species) Acute Toxicity 
Test, must be conducted in accordance with 40 CFR 797.1300. It provides 
data on the acute toxicity of chemical substances. The guideline 
prescribes an acute toxicity test in which Daphnia are exposed to a 
chemical in static and flow-through systems for assessing the hazard 
the compound(s) may present to an aquatic environment.
    (2) The second test, the Daphnia Chronic Toxicity Test, must be 
conducted in accordance with 40 CFR 797.1330. It provides 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 
also are used to assess the hazard that the compound(s) may present to 
an aquatic environment.
    (3) The third test, the Fish Early-Life-Stage Toxicity Test, must 
be conducted in accordance with 40 CFR 797.1600. It assesses the 
adverse effects of chemical substances to fish in the early stages of 
their growth and development. Data from this test also are used to 
determine hazards of the compound(s) in an aquatic environment.
    (q) Evaluation of Tier 2 testing. If, after Tier 2 testing, you 
wish to continue the application process, send the Tier 2 testing 
results and analyses to us. You must ensure that copies of all the raw 
data and statistical analyses accompany the laboratory reports and 
final comprehensive report of this test. We will review the data within 
60 days of the day on which we receive your Tier 2 application 
materials.
    (r) Approval after Tier 2 testing. If we determine that the Tier 2 
test data show that the shot or shot coating does not pose a 
significant toxicity danger to migratory birds, other wildlife, or 
their habitats, we will notify you and request payment of a $20,000 
final review and publication fee (payable to the U.S. Fish and Wildlife 
Service).
    (1) After receipt of payment, we will publish a proposed rule in 
the Federal Register stating that we intend to approve this shot or 
shot coating and provide the public with the opportunity to comment. 
The proposed rule 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 2.
    (2) If, at the end of the comment period, we conclude that the shot 
or shot coating does not pose a significant toxicity danger to 
migratory birds, other wildlife, or their habitats, we will approve the 
shot or coating as nontoxic with publication of a final rule in the 
Federal Register and subsequent addition of the shot or coating to the 
list in Sec.  20.21(j).
    (s) Additional testing. If we conclude that the Tier 2 data are 
inconclusive, or if we conclude that the shot or shot coating may pose 
a significant toxicity danger to migratory birds, other wildlife, or 
their habitats, or if public comment on the proposed rule indicates 
that we should require further testing, we will advise you to proceed 
with the additional testing described for Tier 3. We will require Tier 
3 testing before we evaluate the shot any further. If you choose not to 
do Tier 3 testing, we will deny approval of the candidate alloy or shot 
coating.
    (t) Tier 3 application fee. The fee for consideration of a Tier 3 
application is $700. Submit the fee, payable to the U.S. Fish and 
Wildlife Service, with your application.
    (u) Tier 3 testing. We will review your Tier 3 testing plan within 
30 days of the day on which we receive it. All testing procedures in 
the plan should be in compliance with the Good Laboratory Practice 
Standards (40 CFR part 160), except where they conflict with the 
requirements in this section or with a provision of an approved plan. 
We, or our authorized representative, may elect to inspect your 
laboratory facilities and may decline to approve the plan and further 
consideration of the candidate alloy and/or shot coating if the 
facility is not in compliance with the Good Laboratory Practice 
Standards.
    (1) We will not approve the plan, or any part of it, if we deem it 
deficient in any manner with regard to timing, format, or content. We 
will tell you what parts, if any, of the submitted testing procedure to 
disregard, and any modifications to incorporate into the Tier 3 plan 
needed for us to approve it.
    (2) After acceptance of the plan, you may conduct the Tier 3 
testing. You must ensure that copies of the raw data and the 
statistical analyses accompany the laboratory reports and final 
comprehensive report on this test.
    (i) Chronic toxicity test. This is a 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 following general guidelines unless we tell you otherwise.
    (A) Test materials. You will need 36 male and 36 female hand-reared 
mallards approximately 6 to 8 months old with plumage and body 
conformation of wild mallards; 72 elevated outdoor pens equipped with

[[Page 14068]]

feeders and waterers; a laboratory equipped to perform fluoroscopy, 
required blood and tissue assays, and necropsies; whole kernel corn; 
and lead, steel, and candidate alloy or shot with the proposed coating.
    (B) Test procedures.
    (1) 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).
    (2) Assign individual mallards to elevated outdoor pens during the 
first week of December and give them an unrestricted diet of whole 
kernel corn for 2 weeks.
    (3) Randomly assign birds to five groups--a lead group of four 
males and four females, and four other groups of eight males and eight 
females per group.
    (4) Dose each bird in the lead group (the positive control) with 
one U.S. No. 4 pellet of lead shot. Dose each bird in one group of 
eight males and eight females with eight U.S. No. 4 pellets of steel 
shot (the negative control). Dose each bird in one remaining group of 
eight males and eight females with one U.S. No. 4 pellet of the 
candidate alloy or shot with the proposed coating, each bird in one of 
the remaining two groups of eight males and eight females with four 
U.S. No. 4 pellets of the candidate alloy or shot with the proposed 
coating, and each bird in the final group of eight males and eight 
females with eight U.S. No. 4 pellets of the candidate alloy or shot 
with the proposed coating.
    (5) Weigh and fluoroscope the birds weekly.
    (6) Weigh all recovered shot to measure erosion.
    (7) 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 dosing, and at the end of days 30 and 60.
    (8) Remove the liver and other appropriate organs from all birds 
that die prior to day 60.
    (9) At the end of 60 days, euthanize all survivors. Remove the 
liver and other appropriate organs from the euthanized birds. Analyze 
the organs for lead and other metals in the candidate alloy or shot 
coating.
    (10) Necropsy all birds that died prior to day 60 to determine any 
pathological conditions associated with their deaths.
    (C) Test analyses.
    (1) 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.
    (2) Analyze physiological data and tissue contaminant data by 
analysis of variance or appropriate statistical procedures to include 
the factors of alloy, dose, and sex.
    (3) Compare euthanized birds and birds that died prior to being 
euthanized whenever sample sizes are adequate for a meaningful 
comparison.
    (ii) Chronic dosing study. This moderately long-term study includes 
an assessment of reproduction. Conduct a chronic exposure reproduction 
trial within the following general guidelines unless we tell you 
otherwise.
    (A) Test materials. You will need 44 male and 44 female hand-reared 
first-year mallards with plumage and body conformation of wild 
mallards; pens suitable for quarantine and acclimation and for 
reasonably holding 5 to 10 ducks each; 44 elevated pens equipped with 
feeders, waterers, and nest boxes; a laboratory equipped to perform 
fluoroscopy, required blood and tissue assays, and necropsies; whole 
kernel corn, and commercial duck maintenance and breeder mash; and U.S. 
No. 4 lead, steel, and candidate alloy or shot with the proposed 
coating.
    (B) Test procedures.
    (1) In December, randomly assign the mallards to 3 groups--a 
positive control group of 4 males and 4 females that will be tested 
with lead; a negative control group of 20 males and 20 females that 
will be tested with steel; and a final group with 20 males and 20 
females that will be tested with the candidate alloy or shot with the 
proposed coating. Hold the ducks in same-sex groups until mid-January. 
If the test is not conducted in the northern United States or 
comparable latitudes, the test must be completed in low-temperature 
units.
    (2) After a 3-week acclimation period in which the ducks are fed 
with commercial maintenance mash, provide them an unrestricted diet of 
corn for 60 days and then pair them, put one pair in each pen, and 
provide them with commercial breeder mash.
    (3) After the acclimation period, dose each bird in the lead group 
with 1 pellet of U.S. No. 4 lead shot, each bird in one of the groups 
of 20 males and 20 females with 8 pellets of U.S. No. 4 steel shot, and 
each bird in the remaining group of 20 males and 20 females with 8 
pellets of U.S. No. 4 candidate alloy or shot with the proposed 
coating.
    (4) Redose each bird with the appropriate shot after 30, 60, and 90 
days. Few, if any, of the lead-dosed birds should survive and 
reproduce.
    (5) Fluoroscope each bird 1 week after dosing it to check for shot 
retention.
    (6) Weigh each bird the day of initial dosing (day 0), at each 
subsequent dosing, and at death.
    (7) Collect a blood sample from each bird on the days on which they 
are dosed and immediately prior to euthanizing them.
    (8) Check nests daily and collect any eggs laid. Note the date of 
first egg laid and the mean number of days per egg laid. Conclude 
monitoring of laying after 21 normal, uncracked eggs are laid or after 
150 days.
    (9) Collect eggs and discard any eggs laid before pairing.
    (10) Euthanize the adults after they complete laying or after 150 
days.
    (11) Remove the liver and other appropriate organs from each 
euthanized bird and from each bird that dies prior to being euthanized.
    (12) Analyze the organs and the eleventh egg for compounds 
contained in the shot or shot coating.
    (13) Necropsy all the birds to determine any pathological 
conditions that affected them.
    (14) Artificially incubate the normal eggs and calculate the 
percent shell thickness for each (compared to typical shell thickness), 
the percent of eggs cracked, the percent fertility (as determined by 
candling), and the percentage of fertile eggs hatched for each female.
    (15) Provide ducklings that hatch with starter mash. Euthanize all 
ducklings at 14 days of age.
    (16) Determine survival to day 14 and weight of the ducklings at 
hatching and at being euthanized.
    (17) Measure duckling blood for hemoglobin concentration and other 
blood chemistries using blood samples drawn when the ducklings are 
euthanized.
    (C) Test analyses. Any mortality, reproductive inhibition, or 
effects on physiological parameters due to the shot or shot coating 
must not be significantly greater than those caused by steel shot. If 
necessary, transform percentage data with an arcsine, square root, or 
other suitable transformation prior to statistical analyses. Analyze 
the physiological and reproductive data with one-tailed t-tests or 
other appropriate statistical procedures with [alpha] = 0.05, and 
[beta] = 0.8.
    (v) Evaluation of Tier 3 testing. Report the results of your Tier 3 
testing to us. We will review the data within 60 days of the day on 
which we receive your Tier 3 application materials. You must ensure 
that copies of the raw data and the statistical analyses accompany the

[[Page 14069]]

laboratory reports and final comprehensive report on this test.
    (w) Approval after Tier 3 testing. If we determine that the Tier 3 
test data show that the shot or shot coating does not pose a 
significant toxicity danger to migratory birds, other wildlife, or 
their habitats, we will notify you and request payment of a $20,000 
final review and publication fee (payable to the U.S. Fish and Wildlife 
Service).
    (1) After receipt of payment, we will publish a proposed rule in 
the Federal Register stating that we intend to approve this shot or 
shot coating and provide the public with the opportunity to comment. 
The proposed rule 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.
    (2) If, at the end of the comment period, we conclude that the shot 
or shot coating does not pose a significant toxicity danger to 
migratory birds, other wildlife, or their habitats, we will approve the 
shot or coating as nontoxic with publication of a final rule in the 
Federal Register and subsequent addition of the shot or coating to the 
list in Sec.  20.21(j).
    (x) Additional testing after Tier 3. If we conclude that the Tier 3 
data are inconclusive, or if we conclude that the shot or shot coating 
may pose a significant toxicity danger to migratory birds, other 
wildlife, or their habitats, we may ask you to repeat tests we deem 
inconclusive. If you choose not to repeat the tests, we will deny 
approval of the candidate alloy or shot coating.
    (y) Denial after Tier 3 testing. If we conclude that the shot or 
shot coating may pose a significant toxicity danger to migratory birds, 
other wildlife, or their habitats, we will notify you that we deny 
approval of the candidate alloy or shot coating.
    (z) Withdrawal of the approval of an alloy or shot coating. If we 
find that an approved alloy or shot coating is not readily detectable 
in the field or has environmental effects or direct toxicological 
effects on biota, we may withdraw our approval of the alloy or shot 
coating. This includes any previously approved alloy or shot coating.
    (1) We may consult the Service Law Enforcement Laboratory to 
determine whether any particular alloy or shot coating is readily 
detectable in the field by law enforcement officers.
    (2) We may consider new evidence that meets the standards of the 
Information Quality Act (Pub. L. 106-554, 2001) under Office of 
Management and Budget Guidance (67 FR 8452-8460, February 22, 2002) 
that shows that an approved alloy or shot coating has significant 
environmental effects or direct toxicological effects that were not 
known when we approved the alloy or shot coating.
    (3) In either case, we will publish a notice in the Federal 
Register informing manufacturers and the public of our pending 
withdrawal of the approval of the alloy or shot coating. We will revise 
the table of approved alloys at Sec.  20.21(j) to reflect the 
withdrawal of the approval, to be effective on January 1st, after 
allowing manufacturers 1 full calendar year to prepare for the change.

    Dated: February 21, 2013
Rachel Jacobson,
Principal Deputy Assistant Secretary for Fish and Wildlife and Parks.
[FR Doc. 2013-04906 Filed 3-1-13; 8:45 am]
BILLING CODE 4310-55-P