[Federal Register Volume 78, Number 42 (Monday, March 4, 2013)]
[Proposed Rules]
[Pages 14060-14069]
From the Federal Register Online via the Government Printing 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 OIRA_Submission@omb.eop.gov (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 hope_grey@fws.gov
(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
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Tier 1..........................................................................................................
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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
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Tier 2..........................................................................................................
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Review of Tier 2 application.................................... 3 249 664
Review of Tier 2 application by USGS toxicologist............... 5 415
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Tier 3..........................................................................................................
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Review of Tier 3 application.................................... 3 249 664
Review of Tier 3 application by USGS toxicologist............... 5 415
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Publication Fees (if application is approved)...................................................................
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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
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Total....................................................... .............. 21,650
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\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 OIRA_Submission@omb.eop.gov (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 hope_grey@fws.gov
(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