[Federal Register Volume 78, Number 248 (Thursday, December 26, 2013)]
[Rules and Regulations]
[Pages 78275-78284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-30873]


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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: Final rule.

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SUMMARY: We, the U.S. Fish and Wildlife Service, revise our regulations 
regarding the approval of nontoxic shot types to make the regulations 
easier to understand. The language governing determination of Estimated 
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 specify the pH level to be used in 
calculating the EEC in water. We also 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 add language for 
withdrawal of shot types 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 required for nontoxic shot approvals. Finally, we add 
fees to cover our costs in evaluating these applications.

DATES: This rule is effective on January 27, 2014.

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 or USFWS) 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 types submit them for FWS approval 
under 50 CFR 20.134 as nontoxic for waterfowl hunting.
    We 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.

Comments on the Proposed Rule

    We published a proposed rule on this regulations revision on March 
4, 2013 (78 FR 14060). We received eight comments or sets of comments 
on the proposed rule. We respond to the significant comments below and 
explain subsequent changes we are making to the proposed regulations.
    Comment. We agree . . . that there is no need to publish a ``Notice 
of Application'' in the Federal Register.
    Comment. ``. . . I speak principally for the handloading hunter 
when I explain how simple it should be to identify his shotshells as 
non-lead in nature. The shot he might be using will be of two types 
usually; either steel or tungsten/alloy balls. Steel is easy to detect 
by simple magnet identification. Tungsten alloys usually deflect at 
least slightly when they are exposed to a rare earth magnet. A simple 
exam of the pellets involves using a needle nose pliers to open up the 
shell and squeeze the shot, and makes obvious to the agent how much 
softer the lead ball is compared to a tungsten/alloy ball. The shell is 
able to be reclosed usually on the spot and no big harm or 
inconv[en]ience has been done to either hunter or agents.
    Now, it is important to understand that these Tungsten alloys are 
not purposely made to be non magnetic. When we make them, if we use 
high enough concentrations of iron to make them more magnetic in 
nature, they spuriously loose [sic] density and become harder, both of 
which is unacceptable to the user . . . So why do we want to create 
entrepreneurial as well as manufacturing hurdles when it is usually 
accepted hunters are doing the right thing and using non-toxic shells. 
Simple common sense should

[[Page 78276]]

prevail, tungsten alloys DO NOT look like lead, and are dissimilar as 
well when manipulated by pliers. I would suggest we concentrate our 
efforts in other areas where we might be able to solve important 
issues.''
    Response. We agree that shells used in waterfowl hunting are often 
loaded with either steel or tungsten-alloy pellets. However, there may 
be other suitable shot types in the future, for which a test device or 
devices may be needed. In addition, testing as the commenter suggests 
will require rendering any tested shell unusable for hunting, at least 
until it is recrimped. A law enforcement officer may not wish to take 
the time in the field to open and test shells, or to have to replace 
any that he or she opens.
    Comment. ``No field test shall be approved if it requires human 
intervention and/or interpretation. In other words the results of a 
field test cannot be influenced by the administer[er]. As an example, a 
field test using rare-earth magnets HELD by a human from a string and 
OBSERVING the effects of the magnets when a shotgun shell was 
introduced to the magnet field requires human intervention and 
interpretation. Such field tests should not be approved.''
    Comment. ``A valid field test must not be influenced by external 
conditions such as wind, snow, rain.''
    Comment. All field tests must be non-invasive. Meaning no officer 
can cut open a shell to conduct a field test. However a game officer 
can cut open a shell to investigate further if given probable cause.
    Response. We agree, and attempt to approve easily-applied field 
tests.
    Comment. ``ANY shot that has a negative impact on the environment 
and/or wildlife shall be denied and revoked if approved.''
    Response. These considerations are the reasons for, and the 
provisions of, this regulation.
    Comment. ``ANY shot that has a negative impact on a game officer's 
ability to use existing practices or equipment in their ability to 
identify Lead shall be denied and revoked if approved.''
    Response. We disagree with this suggestion. We need to be prepared 
to accept new technologies and new ways of ensuring compliance with the 
prohibition on lead shot in waterfowl hunting.
    Comment. ``While it is a good idea to specify pH for water testing, 
one should apply the pH and other parameters specified by EPA for this 
purpose. pH should accordingly be 6.5-9.0 to represent normal range of 
typical freshwater bodies suitable for waterfowl habitat. It is my 
professional opinion that testing at pH of 4.0 will automatically cause 
most presently approved shot types to exceed SMAV's [sic, Species Mean 
Acute Values] for many sensitive organisms. This would include most, if 
not all, types of coated/plated steel shot types!''
    Comment. ``We understand the intent behind specifying the pH levels 
to be used in calculating the EEC I water in item 5 [adding 
specific pH levels to be used in calculating the EEC in water], but we 
believe the new regulations for testing in vitro shot should use the 
extensive database of freshwater parameters specified by the US EPA, as 
they are continuously monitored and updated tor many different 
conditions and for use in a variety of applications (fish and wildlife, 
agriculture, municipal water supply, waste disposal, etc.). We 
understand that the currently approved and accepted requirements are 
those published in a series of documents, ``Aquatic Life Ambient 
Freshwater Quality Criteria-- ``for a wide spectrum of specific water 
parameters''-- and which also reference other EPA documents.
    A specific example of problems that can occur when the EPA 
standards are arbitrarily replaced by other criteria concerns the range 
of pH that should be addressed when performing corrosion testing in 
aqueous environments. EPA recommends that a pH range of 6.5-9.0 should 
be investigated as representative of normal levels encountered in 
natural waters of importance. The newly proposed USFWS range of 4.0-9.0 
appears to represent extreme values that EPA has not included as 
reasonably ``normal''.
    Imposition of a pH value as low as 4.0 would have a catastrophic 
impact on most, it not all, types of currentlyapproved nontoxic shot. 
It is our professional opinion, as a company heavily involved in 
material science, that perhaps only bare, uncoated steel shot would 
survive this type of scrutiny, as all of the metallic shot coatings 
currently approved for corrosion protection of steel (Zn, Cu, Ni, Cr) 
would be rapidly solubilized.
    Indeed, unprotected steel is already known to have its own set of 
problems, including rusting and forming agglomerated ``slugs'' within 
shotshells, resulting in dangerous barrel obstruction. It is our 
opinion that this level of acidity would cause most metals to exceed 
allowable EEC's for 69,000 shot in 3.048 x 10\6\ liters of freshwater, 
and that the most important ``indicator species'' of aquatic organisms 
(e.g., Daphnia, Gammarus, et al.) would not thrive in water of such low 
pH, especially if such acidic values were intermittent or seasonal in 
nature, thereby impeding genetic adaptation of the organisms. In other 
words, at a pH of 4.0, there would be little aquatic life to preserve, 
and metal dissolution would not be a significant additional problem.''
    Response. We agree with these comments. Calculating for a pH range 
of 6.5 to 9.0 will provide a useful assessment of the potential 
concentration (see paragraph (g)(3)(ii) of the rule portion of this 
document).
    Comment. ``Inventing an entirely new (and arbitrary) method of 
measuring and comparing shot hardness values is not a valid materials 
testing approach. Simply require the applicant to certify that the shot 
is softer than gun barrel steels, as determined by standard (e.g., ASTM 
testing) methods.''
    Comment. ``In item 3, specifying that applicants must 
submit a relative hardness value referenced to that of lead as ``1.0'' 
is not very meaningful. The many different material hardness 
measurement methods (e.g., ``Rockwell'' of at least six different 
scales, ``Vickers,'' ``Mohs,'' ``Brinell,'' ``Shore,'' ``Durometer,'' 
et al.) are designed for specific ranges of values and types of 
materials. Perhaps a more meaningful requirement would be to simply 
state whether the submitted shot type is harder or softer than standard 
steel shot. This is meaningful because shotgun manufacturers currently 
differentiate between guns rated for steel and those that are not, 
taking into account important factors other than hardness, notably gun 
barrel bursting strength/pressure ratings.
    Response. We have changed this requirement to state that the 
submitter must inform us of the method used to determine the hardness 
of the shot and the hardness value (see paragraph (e)(4) of the rule 
portion of this document).
    Comment. ``With respect to solubility (and/or ``artificial 
gizzard'') testing, allow applicants to either perform the indicated 
testing or submit published (``in vitro'' and/or ``in vivo'') data 
acceptable to USFWS. (There is no reason to ``reinvent'' data for 
common materials which have already been thoroughly evaluated in prior 
art.)''
    Response. Though we understand the intent of this comment, it would 
be arbitrary to accept test results from similar shot types or shot 
coatings, because different production methods or slightly different 
alloys could mean different solubility test results.
    Comment. ``We agree with item 6 [moving the former Tier 2 
solubility testing to Tier 1], but we believe the

[[Page 78277]]

qualifying condition should be added that original solubility data must 
be submitted with the application ``unless sufficient published data 
from scientific sources acceptable to USFWS can be cited.''
    Response. We will continue to require original solubility testing 
with each application for a new shot type or coating.
    Comment. ``Moving the in vitro evaluation of erosion rate from Tier 
II into Tier I is reasonable. It would be helpful if the citation of 
this method (Kimball, W.H. and Z.A. Munir. 1971. The corrosion of lead 
shot in a simulated waterfowl gizzard. Journal of Wildlife Management 
35(2):360-365) was provided in the document. It should also be stated 
that this testing should be in compliance with Good Laboratory 
Practices Standards.''
    Response. We added the citation for the benefit of applicants, and 
we agree that applicants should follow the standards in 40 CFR 160. We 
added this requirement in paragraph (h).
    Comment. ``Require applicants to demonstrate effectiveness and 
availability of shot detection methods to USFWS's satisfaction, rather 
than calling out one particular type and source of a specific 
instrument.''
    Comment. ``We think the regulation in item 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] for detection in the field should say only that a method for 
confirming that a shotshell contains nontoxic shot must be demonstrated 
by the applicant. It seems inappropriate for the government to make 
reference to one specific commercial product from one small source 
(e.g., ``HOT SHOT'' device from Stream Systems) when metal detection 
technologies (especially electronic types) are continually being 
advanced. We believe USFWS would be better served by simply stating 
that availability of a field method acceptable to USFWS must be 
demonstrated. This approach would encourage innovation and competition 
that may actually benefit law enforcement efforts. It would also 
provide some flexibility to USFWS and manufacturers in the event that a 
particular detection method becomes unavailable or unaffordable to law 
enforcement agencies.''
    Response. The footnote at the end of the approved shot types table 
in 50 CFR 20.21(j)(1) states ``The information in the ``Field Testing 
Device'' column is strictly informational, not regulatory.'' The 
listing is not an endorsement of any particular field testing device, 
such as the ``Hot Shot'' tool. We provide the information about field 
test methods for the use of law enforcement officers. If we become 
aware of any additional suitable field test devices, or if another type 
device is required for a newly approved shot type, we will add it or 
them to the ``Field Testing Device'' column.
    Comment. ``We strongly disagree with item 7 [adding a 
provision for withdrawal of an approved shot type] as a matter of 
resource stewardship. If the shot is nontoxic, changes in detectability 
in the field should not lead to its withdrawal from the market. 
Instead, USFWS can require applicants to demonstrate detectability 
again. If detectability becomes a problem in the field, USFWS can give 
the manufacturer a complete description of the technical problem and a 
reasonable period, perhaps 180 days, to remedy the situation by 
improving either the shot or the detection method.
    These new, nontoxic alloys are not generally materials with years 
of metallurgical practice behind them, and withdrawing approvals on the 
basis of occasional field reports of detection difficulty seems 
arbitrary and capricious, especially when manufacturers could 
potentially fix the problems and continue to offer the products to 
consumers.
    After all the years, solubility testing, animal gavage, process 
development, and quality assurance efforts that a small company 
undertakes to qualify one of these products, allowing USFWS to withdraw 
approval without some kind of reasonable due process seems unfair.
    It also seems to invite competitive manipulation, where competitors 
could allege detection difficulties to slow the adoption of a better 
nontoxic alternative. This area clearly requires more thought before 
USFWS changes policy.''
    Response. Competitors cannot allege detection difficulties; we rely 
on tribal, State, and Federal law enforcement officers to advise us 
about field testing problems. We revised the relevant language at 
paragraph (z)(1) to give shotshell producers opportunities to resolve 
field detection problems.
    Comment. ``I firmly believe that the USFW and tax payers should not 
absorb the costs associated with the approval process of non-toxic 
shot. Adopting fees for the approval process would insure those 
individuals applying for the approval are serious and not wasting the 
USFW time and tax payer's money.''
    Response. We proposed to add the fees to recoup costs to the 
government.
    Comment. ``We strongly disagree with the proposal to increase fees. 
The ``service'' USFWS renders does not ``provide special benefits to an 
identifiable recipient beyond those that accrue to the general 
public.'' The easiest shotshell to make is a lead shotshell. The 
public, that is the nation as a whole, benefits when manufacturers 
advance nontoxic shot technology because it helps conserve the 
migratory waterfowl resource. Once a new shot type is approved, any 
manufacturer with the technology can use the approval. Those without 
the technology can buy approved shot from the producer.
    Our company pioneered high-density tungsten-nickel-iron shot in 
2001, and by 2006 all major ammunition companies had competing 
products. The public benefited from choice and falling prices for 
nontoxic shot. The manufacturers certainly earned no special benefits 
that did not also accrue to the general public.
    Small innovators who manage to surmount the toxicology, solubility, 
and process technology challenges of introducing new nontoxic products 
for the public should not see this effort squashed by a looming $20,000 
fee at the end of the line. This proposal will slow innovation in the 
field, and deprive the public of improvements that lower the cost of 
and encourage compliance with nontoxic regulations.
    We could agree with the higher review fees, which we do not think 
will impede innovation. But the Federal Register fee is prohibitively 
high for a small company, and small companies have been behind most of 
the innovation in nontoxic shot products.''
    Response. Office of Management and Budget Circular A-25 establishes 
Federal policy regarding fees assessed for Government services. We 
proposed to add fees to cover costs that we would continue to have to 
absorb in reviewing nontoxic shot or shot coating submissions and 
changing the regulations to approve them. The Federal Register fee will 
be a burden for companies that submit nontoxic shot or shot coatings, 
but it has been a burden for the Division of Migratory Bird Management. 
This provision of the proposed rule is unchanged.
    Comment. Recovery of staff costs for the review of a submission is 
a great notion . . . However, I believe the proposed staff hours for 
review may underestimate the actual cost and value. I would propose 40 
hours for each of the Tiers.
    Response. In the proposed rule, we estimated fewer hours for 
reviews conducted by our colleagues at the U.S.

[[Page 78278]]

Geological Survey (USGS) than the commenter suggests. After considering 
this comment and further reviewing the work required of USGS, which 
involves conducting and checking calculations, determining if the 
literature review is thorough and accurate, and drafting a response 
with comments to provide for our use in carrying out the rulemaking 
process, we change the estimated review time for the USGS toxicologist 
for each tier from 5 to 15 hours. The estimated cost for the Tier 1 
USGS review, therefore, rises from $415 in the proposed rule to $1,245. 
Subsequently, we revise the Tier 1 review fee from $800 to $1,630. We 
revise the Tier 2 fee and Tier 3 fees to $1,530 each (see paragraphs 
(d), (l), and (t) in the rule portion of this document.).
    Comment. ``As a non-hunter who picks up litter, I note a lot of 
plastic shot gun shells are discarded during hunting. Any chance of 
looking at whether those plastics are laden with BPAs and other toxins 
that can leach as well? Might there ever be a safe (for the hunter) and 
truly biodegradable shell? Were there paper casings before plastic?''
    Response. Paper shotgun shells were in use long before plastic 
shells, but the bases of the shells are still metal. The idea of a 
biodegradable shell is laudable, but it might create problems for 
hunters because the shells may get wet and dirty before they are used. 
We agree that fired shotgun shells should not be discarded in the 
field. However, this regulation is limited to the approval of the shot 
types and shot coatings used in waterfowl and coot hunting.

Other Changes From the Proposed Rule

    We added invertebrates to the listing of potentially affected biota 
in paragraph (f)(4). Assessment of impacts of a shot type or coating on 
invertebrates is required in paragraph (g). We intended to be 
consistent between paragraphs (f) and (g), but we inadvertently left 
``invertebrates'' out of paragraph (f)(4).
    We added a requirement in paragraph (o)(2)(x) to weigh all 
recovered shot and determine shot erosion. Weighing the shot and 
determining erosion should have been in the proposed rule because, 
without this analysis, the erosion testing is not complete.

Required Determinations

Regulatory Planning and Review (Executive Orders 12866 and 13563)

    Executive Order 12866 provides that the Office of Information and 
Regulatory Affairs (OIRA) in the Office of Management and Budget 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 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 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 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 rule requires additional information in the initial application 
and increases the application fee. As a result, companies applying for 
nontoxic shot approval will 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, and in some years we receive none. Less 
than one percent of affected small businesses would be impacted.
    The rule has minimal impacts 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 rule includes application fees because 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 in the proposed 
rule). Because we are required to publish each approved nontoxic shot 
application in the Federal Register, we will recoup these fees from 
each company that applies for a nontoxic shot approval.
    We have examined this 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. We certify that this 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 is not a major rule under 5 U.S.C. 804(2), the Small Business 
Regulatory Enforcement Fairness Act.
    a. This 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 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 rule will not have significant adverse effects on 
competition, employment, investment, productivity, innovation, or the 
ability of U.S.-based

[[Page 78279]]

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 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 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 regulation revision will 
not affect State regulations.

Takings

    This 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 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 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 this 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 rule contains a collection of information that we submitted to 
the Office of Management and Budget (OMB) for review and approval under 
Sec. 3507(d) of the Paperwork Reduction Act (PRA). OMB has approved the 
information collection requirements associated with the approval of 
nontoxic shot for use in waterfowl hunting and assigned OMB Control 
Number 1018-0067, which expires ----. 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.
    The regulations at 50 CFR 20.134 contain the following new 
information collection 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.
     For shot types, the application must include a statement 
of the hardness of the candidate alloy and the method used to determine 
the hardness. 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 Estimated Environmental Concentrations (EECs) in 
terrestrial and aquatic ecosystems.
     A provision for testing loaded shotshells containing an 
approved shot type and revoking approval of that shot type if it is not 
identifiable in loaded shotshells held in the hand in the field. Slight 
manufacturing changes can alter the chemical and magnetic properties of 
an approved shot so that it cannot be detected in the field. This has 
created enforcement problems for law enforcement officers.
     Requirement to weigh all recovered shot and determine shot 
erosion.
     Specific pH level 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; therefore, we have not increased 
the completion time for an application. In addition to the above 
requirements, we 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 adding fees for different stages of an application 
sufficient to offset the estimated costs associated with processing the 
application. We have increased our estimate of the nonhour burden cost 
by including the $1,630 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.
    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: $26,630 ($1,630 for 
application processing fees, plus $25,000 for solubility testing).
    You may send comments on any aspect of these information collection 
requirements to the Service Information Collection Clearance Officer, 
U.S. Fish and Wildlife Service, 4401 N. Fairfax Drive, Mail Stop 2042-
PDM, Arlington, VA 22203 (mail) or hope_grey@fws.gov (email).

National Environmental Policy Act

    We have analyzed this rule in accordance with the criteria of the 
National Environmental Policy Act and 516 DM. This 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 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 Action

    The changes are primarily in the reorganizing and rewriting of the 
regulations. The environmental impacts of this action are minimal.
    Socio-economic. This rule will have no socio-economic impacts.
    Wildlife populations. This regulations change does not 
significantly alter the approval of nontoxic shot in the United States. 
This rule will not affect wildlife populations.
    Endangered and threatened species. The regulations change will not 
affect 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 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 rule will not 
affect energy

[[Page 78280]]

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.

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 hereby 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 continues to read as follows:

    Authority: 16 U.S.C. 703-712.


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


Sec.  20.134  Approval of nontoxic shot types and shot 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 a shot type 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., Washington, 
DC 20240.
    (b) Limitations on nontoxic shot type approval. We will not approve 
as nontoxic any shot type or shot coating with a lead content of 1 
percent or more.
    (1) Before we will approve any shot type or shot coating as 
nontoxic, a shotshell loaded with the shot type or coated shot must be 
demonstrated to be identifiable as not being lead in a portable field 
testing device for use 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 shot types 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 $1,630. Submit the fee, payable to the U.S. Fish and 
Wildlife Service, with your application.
    (e) Tier 1 application. If you wish to submit a shot type 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 hardness of the candidate shot type 
and the method used to determine the hardness.
    (5) Provide a statement of the expected variability of shot during 
production.
    (6) Provide an estimate of yearly volume of candidate shot type 
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 shot type 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 shot type 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).

[[Page 78281]]



------------------------------------------------------------------------
              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 
invertebrates, fish, amphibians, reptiles, or mammals is cause for 
concern. If there is a recognized impact on invertebrates, 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 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, and other 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 6.5 to 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 shot type 
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 (see 
W.H. Kimball and Z.A. Munir, 1971, The corrosion of lead shot in a 
simulated waterfowl gizzard, Journal of Wildlife Management 35:360-365) 
for basic test procedures. 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 shot type 
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 shot type 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

[[Page 78282]]

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 shot type or shot coating.
    (l) Tier 2 application fee. The fee for consideration of a Tier 2 
application is $1,530. 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 will cease further consideration of the 
candidate shot type 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 using the following method unless we specify otherwise. The 
testing should be done in accordance with Good Laboratory Practices 
Standards at 40 CFR part 160.
    (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 shot type.
    (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 8 pellets of either U.S. 
No. 4 lead shot (positive control), steel shot (negative control), or 
the candidate shot type 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 shot type or shot with the proposed coating.
    (ix) Perform a necropsy of all birds to determine any gross and/or 
microscopic pathological conditions.
    (x) Weigh all recovered shot and determine shot erosion.
    (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 shot type 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

[[Page 78283]]

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 shot type or shot 
coating.
    (t) Tier 3 application fee. The fee for consideration of a Tier 3 
application is $1,530. 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 shot type 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 
feeders and waterers; a laboratory equipped to perform fluoroscopy, 
required blood and tissue assays, and necropsies; whole kernel corn; 
and lead, steel, and candidate shot type 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 4 males 
and 4 females, and 4 other groups of 8 males and 8 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 8 
males and 8 females with 8 U.S. No. 4 pellets of steel shot (the 
negative control). Dose each bird in 1 remaining group of 8 males and 8 
females with one U.S. No. 4 pellet of the candidate shot type or shot 
with the proposed coating, each bird in 1 of the remaining 2 groups of 
8 males and 8 females with 4 U.S. No. 4 pellets of the candidate shot 
type or shot with the proposed coating, and each bird in the final 
group of 8 males and 8 females with 8 U.S. No. 4 pellets of the 
candidate shot type or shot with the proposed coating.
    (5) Weigh and fluoroscope the birds weekly.
    (6) Weigh all recovered shot and determine shot 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 shot type or shot 
coating.
    (10) Necropsy all birds that died prior to day 60 to determine any 
gross and/or microscopic 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, with [alpha] 
= 0.05, and [beta] = 0.8.
    (2) 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 with [alpha] = 0.05, and [beta] 
= 0.8.
    (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 shot type 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 shot type 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 shot type 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 it 
is dosed and immediately prior to euthanizing it.
    (8) Check nests daily and collect any eggs laid. Note the date of 
first egg laid

[[Page 78284]]

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 gross and/or 
microscopic 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 
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 shot type 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 shot type or shot coating.
    (z) Withdrawal of the approval of a shot type or shot coating. If 
we find that an approved shot type 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 
shot type or shot coating. This includes any previously approved shot 
type or shot coating.
    (1) We may consult the Service Law Enforcement Laboratory to 
determine whether any particular shot type or shot coating is readily 
detectable in the field by law enforcement officers. If the shot type 
is not readily detectable in the field, we will give the shotshell 
producer 180 days to remedy the situation by improving either the shot 
or the detection method.
    (2) We may consider new evidence, consistent with the provisions of 
the Migratory Bird Treaty Act and the Information Quality Act (Pub. L. 
106-554, 2001; Office of Management and Budget Guidance, 67 FR 8452-
8460, February 22, 2002) that shows that an approved shot type or shot 
coating has significant environmental effects or direct toxicological 
effects that were not known when we approved the shot type or shot 
coating.
    (3) After the 180-day period for a shot type that cannot be tested 
in the field (see paragraph (z)(1) of this section), or at any time 
after we learn of significant environmental effects or direct 
toxicological effects, we will publish a notice in the Federal Register 
informing manufacturers and the public of our pending withdrawal of the 
approval of the shot type or shot coating. We will revise the table of 
approved shot types 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: December 19, 2013.
Rachel Jacobson,
Principal Deputy Assistant Secretary for Fish and Wildlife and Parks.
[FR Doc. 2013-30873 Filed 12-24-13; 8:45 am]
BILLING CODE 4310-55-P