Proposed Rule

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Federal Register / Vol. 78, No. 42 / Monday, March 4, 2013 / Proposed Rules

Dated: February 21, 2013.
Paul F. Thomas,
Director of Inspections and Compliance, U.S.
Coast Guard.

M. Scott Johnson and Daniel A.
Kirkpatrick, Fletcher, Heald & Hildreth,
P.L.C., 1300 North 17th Street, 11th
Floor, Arlington, VA 22209.

[FR Doc. 2013–04866 Filed 3–1–13; 8:45 am]

FOR FURTHER INFORMATION CONTACT:

BILLING CODE 9110–04–P

Peter Saharko, [email protected],
Media Bureau, (202) 418–1856.

FEDERAL COMMUNICATIONS
COMMISSION

SUPPLEMENTARY INFORMATION:

47 CFR Part 73
[MB Docket No. 13–40, RM–11691; DA 13–
160]

Television Broadcasting Services;
Seaford, Delaware and Dover,
Delaware
Federal Communications
Commission.
ACTION: Proposed rule.
AGENCY:

The Commission has before it
a petition for rulemaking filed by
Western Pacific Broadcast, LLC
(‘‘Western Pacific’’), the permittee of
unbuilt station WMDE(TV), Channel 5,
Seaford, Delaware, requesting an
amendment of the DTV Table of
Allotments to delete Channel 5 at
Seaford and substitute Channel 5 at
Dover, Delaware. Western Pacific
further requests modification of
WMDE(TV)’s construction permit to
specify Dover, Delaware as the station’s
community license and seeks a waiver
of the Commission’s freeze on the filing
of petitions for rulemaking by
televisions stations seeking to change
their community of license. Western
Pacific asserts that its proposal to reallot
Channel 5 to Dover is based on the
technical specifications currently
authorized for WMDE(TV), and
therefore the new allotment will be
mutually exclusive with the station’s
existing allotment. Western Pacific
further states that its proposal meets the
Commission’s allotment priorities by
providing Dover with its first local
television service, and that Seaford will
remain well-served after the reallotment
because full-power noncommercial
station WDPB(TV), Channel *44, will
remain licensed to that community.
Therefore, Western Pacific submits that
this rulemaking will serve the public
interest.

sroberts on DSK5SPTVN1PROD with PROPOSALS

SUMMARY:

Comments must be filed on or
before April 3, 2013, and reply
comments on or before April 18, 2013.
ADDRESSES: Federal Communications
Commission, Office of the Secretary,
445 12th Street SW., Washington, DC
20554. In addition to filing comments
with the FCC, interested parties should
serve counsel for petitioner as follows:
DATES:

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This is a
synopsis of the Commission’s Notice of
Proposed Rule Making, MB Docket No.
13–40, adopted February 12, 2013, and
released February 13, 2013. The full text
of this document is available for public
inspection and copying during normal
business hours in the FCC’s Reference
Information Center at Portals II, CY–
A257, 445 12th Street SW., Washington,
DC, 20554. This document will also be
available via ECFS (http://www.fcc.gov/
cgb/ecfs/). (Documents will be available
electronically in ASCII, Word 97, and/
or Adobe Acrobat.) This document may
be purchased from the Commission’s
duplicating contractor, Best Copy and
Printing, Inc., 445 12th Street SW.,
Room CY–B402, Washington, DC 20554,
telephone 1–800–478–3160 or via email
www.BCPIWEB.com. To request this
document in accessible formats
(computer diskettes, large print, audio
recording, and Braille), send an email to
[email protected] or call the Commission’s
Consumer and Governmental Affairs
Bureau at (202) 418–0530 (voice), (202)
418–0432 (TTY). This document does
not contain proposed information
collection requirements subject to the
Paperwork Reduction Act of 1995,
Public Law 104–13. In addition,
therefore, it does not contain any
proposed information collection burden
‘‘for small business concerns with fewer
than 25 employees,’’ pursuant to the
Small Business Paperwork Relief Act of
2002, Public Law 107–198, see 44 U.S.C.
3506(c)(4).
Provisions of the Regulatory
Flexibility Act of 1980 do not apply to
this proceeding. Members of the public
should note that from the time a Notice
of Proposed Rule Making is issued until
the matter is no longer subject to
Commission consideration or court
review, all ex parte contacts (other than
ex parte presentations exempt under 47
CFR 1.1204(a)) are prohibited in
Commission proceedings, such as this
one, which involve channel allotments.
See 47 CFR 1.1208 for rules governing
restricted proceedings.
For information regarding proper
filing procedures for comments, see 47
CFR 1.415 and 1.420.
List of Subjects in 47 CFR Part 73
Television, Television broadcasting.

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Federal Communications Commission
Barbara A. Kreisman,
Chief, Video Division, Media Bureau.

Proposed Rules
For the reasons discussed in the
preamble, the Federal Communications
Commission proposes to amend 47 CFR
part 73 as follows:
PART 73—RADIO BROADCAST
SERVICES
1. The authority citation for part 73
continues to read as follows:

■

Authority: 47 U.S.C. 154, 303, 334, 336,
and 339.
§ 73.622

[Amended]

2. Section 73.622(i), the PostTransition Table of DTV Allotments
under Delaware is amended by
removing channel 5 from Seaford and
adding channel 5 at Dover.

■

[FR Doc. 2013–04832 Filed 3–1–13; 8:45 am]
BILLING CODE 6712–01–P

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
Fish and Wildlife Service,
Interior.
ACTION: Proposed rule.
AGENCY:

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 fieldtesting device is available. We expect
these changes to reduce the time

SUMMARY:

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Federal Register / Vol. 78, No. 42 / Monday, March 4, 2013 / Proposed Rules

sroberts on DSK5SPTVN1PROD with PROPOSALS

required for nontoxic shot approvals.
Finally, we propose to charge fees to
cover our costs in evaluating these
applications.
DATES: Electronic comments on this
proposal via http://www.regulations.gov
must be submitted by 11:59 p.m. Eastern
time on June 3, 2013. Comments
submitted by mail must be postmarked
no later than June 3, 2013. Comments on
the information collection requirements
are due no later than April 3, 2013.
ADDRESSES: You may submit comments
by either of the following two methods:
• Federal eRulemaking portal: http://
www.regulations.gov. Follow the
instructions for submitting comments
on Docket No. FWS–R9–MB–2011–
0077.
• U.S. mail or hand delivery: Public
Comments Processing, Attention: FWS–
R9–MB–2011–0077; Division of Policy
and Directives Management; U.S. Fish
and Wildlife Service; 4401 North Fairfax
Drive, MS 2042–PDM; Arlington, VA
22203–1610.
We will not accept email or faxes. We
will post all comments on http://
www.regulations.gov. This generally
means that we will post any personal
information that you provide. See the
Public Comments section below for
more information.
Submit comments on the information
collection requirements to the Desk
Officer for the Department of the
Interior at Office of Management and
Budget, Office of Information and
Regulatory Affairs (OMB–OIRA) at (202)
395–5806 (fax) or
[email protected]
(email). Please provide a copy of your
comments to the Service Information
Collection Clearance Officer, U.S. Fish
and Wildlife Service, MS 2042–PDM,
4401 North Fairfax Drive, Arlington, VA
22203 (mail), or [email protected]
(email).
FOR FURTHER INFORMATION CONTACT: Dr.
George Allen, 703–358–1825.
SUPPLEMENTARY INFORMATION:
Background
The Migratory Bird Treaty Act of 1918
(Act) (16 U.S.C. 703–712 and 16 U.S.C.
742 a–j) implements migratory bird
treaties between the United States and
Great Britain for Canada (1916 and 1996
as amended), Mexico (1936 and 1972 as
amended), Japan (1972 and 1974 as
amended), and Russia (then the Soviet
Union, 1978). These treaties protect
certain migratory birds from take, except
as permitted under the Act. The Act
authorizes the Secretary of the Interior
to regulate take of migratory birds in the
United States. Under this authority, the
U.S. Fish and Wildlife Service (FWS)

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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

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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 fieldtesting 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.

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Federal Register / Vol. 78, No. 42 / Monday, March 4, 2013 / Proposed Rules

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

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.

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

TABLE 1—CURRENT HOURS AND COSTS FOR PROCESSING A NONTOXIC SHOT APPROVAL APPLICATION
Task

Approximate
cost

Staff hours

Review cost

Tier 1
Review application for completeness ..........................................................................................
Review by U.S. Geological Survey toxicologist ..........................................................................
Consult with U.S. Geological Survey toxicologist .......................................................................

2
5
2

1 $166

3
5

249
415

664

3
5

249
415

664

1,660

19,575

$747

415
166

Tier 2
Review of Tier 2 application ........................................................................................................
Review of Tier 2 application by USGS toxicologist .....................................................................
Tier 3
Review of Tier 3 application ........................................................................................................
Review of Tier 3 application by USGS toxicologist .....................................................................
Publication Fees (if application is approved)
Prepare draft environmental assessment and proposed rule .....................................................
Proposed rule Federal Register charges ...................................................................................
Review comments and prepare final environmental assessment and final rule ........................
Final rule Federal Register charges ..........................................................................................

20

Total ......................................................................................................................................

........................

2 11,000

5

415
3 6,500

21,650

1 Staff

review costs are based on Washington, D.C. metro area salary and benefits for a GS13/10 biologist ($55.46/hour * 1.5 for benefits, or
about $83/hour).
2 Average publication cost of nontoxic shot proposed rules from 2001 through 2011 was $10,695.
3 Average publication cost of nontoxic shot final rules from 2001 through 2011 was $6,122.50.

sroberts on DSK5SPTVN1PROD with PROPOSALS

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.

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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

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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

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sroberts on DSK5SPTVN1PROD with PROPOSALS

Federal Register / Vol. 78, No. 42 / Monday, March 4, 2013 / Proposed Rules
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

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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

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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;

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

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comments to the Service Information
Collection Clearance Officer, U.S. Fish
and Wildlife Service, MS 2042–PDM,
4401 North Fairfax Drive, Arlington, VA
22203 (mail), or [email protected]
(email).
National Environmental Policy Act
We have analyzed this proposed rule
in accordance with the criteria of the
National Environmental Policy Act and
516 DM. This proposed rule does not
constitute a major Federal action
significantly affecting the quality of the
human environment, and does not
require the preparation of an
environmental impact statement or an
environmental assessment. The changes
we propose are largely to reorganize the
regulations and put them into easier-tounderstand 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

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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]
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.

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

■

sroberts on DSK5SPTVN1PROD with PROPOSALS

§ 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

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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 halflife, 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

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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,
over 5 to 50 mg/kg,
over 50 to 500 mg/kg,
over 500 to 5,000 mg/kg,
over 5,000 to 15,000 mg/
kg,
over 15,000 mg/kg,

super toxic.
extremely toxic.
very toxic.
moderately toxic.
slightly toxic.
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

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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 (ft2)) 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 ft2, 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.
adverse effects are possible.
adverse effects are likely.

0.1 to 10.0,

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greater than 10.0,

(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.

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(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®-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®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/ft2 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

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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 § 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

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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 chisquare, with a = 0.05, and b = 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 a = 0.05 and b = 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

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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-LifeStage 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

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14067

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 § 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 longterm 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

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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 chisquare statistical procedures. Any
effects on the previously mentioned
physiological parameters caused by the
shot or shot coating must be

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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 firstyear 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 midJanuary. 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.

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(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 a
= 0.05, and b = 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

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sroberts on DSK5SPTVN1PROD with PROPOSALS

Federal Register / Vol. 78, No. 42 / Monday, March 4, 2013 / Proposed Rules
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 § 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

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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 § 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

DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 622
RIN 0648–BC58

Fisheries of the Caribbean, Gulf of
Mexico, and South Atlantic; Shrimp
Fishery Off the Southern Atlantic
States; Amendment 9
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Notice of availability; request
for comments.
AGENCY:

The South Atlantic Fishery
Management Council (Council) has
submitted Amendment 9 (Amendment
9) to the Fishery Management Plan for
the Shrimp Fishery of the South
Atlantic Region (FMP) for review,
approval, and implementation by
NMFS. Amendment 9 would revise the
criteria and procedures by which South
Atlantic states may request a concurrent
closure of the penaeid shrimp (brown,
pink, and white shrimp) commercial
sector in the exclusive economic zone
(EEZ) in order to protect overwintering
white shrimp. Amendment 9 would also
update the current overfished and
overfishing status determination criteria
for pink shrimp.
DATES: Written comments must be
received on or before May 3, 2013.
ADDRESSES: You may submit comments
on the amendment identified by
‘‘NOAA–NMFS–2012–0227’’ by any of
the following methods:
SUMMARY:

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14069

• Electronic submissions: Submit
electronic comments via the Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Kate Michie, Southeast
Regional Office, NMFS, 263 13th
Avenue South, St. Petersburg, FL 33701.
Instructions: All comments received
are a part of the public record and will
generally be posted to http://
www.regulations.gov without change.
All Personal Identifying Information (for
example, name, address, etc.)
voluntarily submitted by the commenter
may be publicly accessible. Do not
submit Confidential Business
Information or otherwise sensitive or
protected information.
To submit comments through the
Federal e-Rulemaking Portal: http://
www.regulations.gov, enter ‘‘NOAA–
NMFS–2012–0227’’ in the search field
and click on ‘‘search’’. After you located
the notice of availability, click on
‘‘Submit a Comment’’ link in that row.
This will display the comment Web
form. You can enter your submitter
information (unless you prefer to remain
anonymous), and type your comment on
the Web form. You can also attach
additional files (up to 10 MB) in
Microsoft Word, Excel, WordPerfect, or
Adobe PDF file formats only.
Comments received through means
not specified in this rule will not be
considered.
For further assistance with submitting
a comment, see the ‘‘Commenting’’
section at http://www.regulations.gov/
#!faqs or the Help section at http://
www.regulations.gov.
Electronic copies of Amendment 9
may be obtained from the Southeast
Regional Office Web site at http://
sero.nmfs.noaa.gov. Amendment 9
includes a Regulatory Impact Review
and a Fishery Impact Statement.
FOR FURTHER INFORMATION CONTACT: Kate
Michie, telephone: 727–824–5305, or
email: [email protected].
SUPPLEMENTARY INFORMATION: The
Magnuson-Stevens Fishery
Conservation and Management Act
(Magnuson-Stevens Act) requires each
regional fishery management council to
submit any fishery management plan or
amendment to NMFS for review and
approval, partial approval, or
disapproval. The Magnuson-Stevens Act
also requires that NMFS, upon receiving
a plan or amendment, publish an
announcement in the Federal Register
notifying the public that the plan or
amendment is available for review and
comment.
The penaeid shrimp fishery of the
South Atlantic is managed under the

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