[Federal Register Volume 78, Number 143 (Thursday, July 25, 2013)]
[Rules and Regulations]
[Pages 44878-44881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17751]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1240
[Docket No. FDA-2013-N-0639]
Turtles Intrastate and Interstate Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations regarding the prohibition on the sale, or other commercial
or public distribution, of viable turtle eggs and live turtles with a
carapace length of less than 4 inches to remove procedures for
destruction as FDA believes it is not necessary to routinely demand
this destruction to achieve the purpose of the regulations. This action
will reduce
[[Page 44879]]
the need for investigator training and the time for the care and humane
destruction of these animals.
DATES: This rule is effective January 16, 2014. Submit either
electronic or written comments by October 8, 2013. If FDA receives no
significant adverse comments within the specified comment period, the
Agency will publish a document confirming the effective date of the
final rule in the Federal Register within 30 days after the comment
period on this direct final rule ends. If timely significant adverse
comments are received, the Agency will publish a document in the
Federal Register withdrawing this direct final rule before its
effective date.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0639, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
Mail/Hand delivery/Courier (For paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2013-N-0639 for this rulemaking. All comments
received may be posted without change to http://www.regulations.gov,
including any personal information provided. For additional
instructions on submitting comments, see the ``Comments'' heading of
the SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Dillard Woody, Center for Veterinary
Medicine (HFV-231), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9237, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA published regulations in 21 CFR 1240.62 on May 23, 1975 (40 FR
22543), that ban the sale and distribution of viable turtle eggs and
turtles with a carapace length of less than 4 inches to stop the spread
of turtle-associated salmonellosis in humans, especially in young
children.
The regulations provide that viable turtle eggs and live turtles
with a carapace length of less than 4 inches shall not be sold, held
for sale, or offered for any other type of commercial or public
distribution. The ban does not apply to such distribution for bona fide
scientific, educational, or exhibitional purposes other than use as
pets; to such distribution not in connection with a business; and to
such distribution intended for export only. In addition, the turtle ban
does not apply to marine turtles and their eggs.
The regulations further provide that any turtle eggs or live
turtles with a carapace length of less than 4 inches that are held for
sale or offered for any other type of commercial or public distribution
in violation of the regulations shall be subject to destruction in a
humane manner by or under the supervision of an officer or employee of
FDA, in accordance with specified procedures. Once a written demand for
destruction is served, the rule prohibits the selling, distributing, or
otherwise disposing of the viable turtle eggs or live turtles in a
manner other than destroying them under FDA supervision.
FDA is amending the regulations to remove the provisions making
violative turtle eggs and live turtles routinely subject to destruction
by or under the supervision of an officer or employee of FDA. FDA does
not believe that it is necessary to routinely demand destruction of
viable turtle eggs and live turtles with a carapace length of less than
4 inches. FDA believes that other activities will achieve the purpose
of the regulations, which were enacted to prevent the spread of turtle-
associated salmonellosis, especially to young children. These other
alternatives include: Raising the turtles until the turtles achieve a
carapace length of 4 inches or greater; donating the viable turtle eggs
or live turtles to an entity that meets one of the bona fide
scientific, educational, or exhibitional exemptions, as provided in the
regulations; or exporting the turtles in compliance with all applicable
laws.
Although FDA does not believe that it is necessary to routinely
demand destruction of viable turtle eggs and live turtles with a
carapace length of less than 4 inches, as provided for in the
regulations, FDA recognizes that it has the authority and obligation to
take appropriate measures to prevent the spread of communicable
disease, especially in the face of widespread outbreaks or other public
health emergencies. FDA retains the authority to destroy or order the
destruction of viable turtle eggs or live turtles of any size under 21
CFR 1240.30, which provides that, ``[w]henever the Commissioner of Food
and Drugs determines that the measures taken by health authorities of
any State or possession (including political subdivision thereof) are
insufficient to prevent the spread of any of the communicable diseases
. . . he may take such measures to prevent such spread of the diseases
as he deems reasonably necessary, including . . . destruction of
animals or articles believed to be sources of infection.''
This direct final rule does not affect the ban on the sale of
viable turtle eggs and live turtles with a carapace length of less than
4 inches. Those provisions of the regulations remain in effect.
Violators are subject to a fine of not more than $1,000 or imprisonment
for not more than 1 year, or both, for each violation, in accordance
with section 368 of the Public Health Service Act (PHS Act) (42 U.S.C.
271).
II. Direct Final Rulemaking
FDA has determined that the subject of this rulemaking is suitable
for a direct final rule. FDA is amending 21 CFR 1240.62 by removing the
provisions making viable turtle eggs and live turtles with a carapace
length of less than 4 inches that are held for sale or offered for any
other type of commercial or public distribution in violation of the
regulations routinely subject to destruction and the associated
required procedures. This rule is intended to make noncontroversial
changes to existing regulations. The Agency does not anticipate
receiving any significant adverse comment on this rule.
Consistent with FDA's procedures on direct final rulemaking, we are
publishing elsewhere in this issue of the Federal Register a companion
proposed rule. The companion proposed rule and this direct final rule
are substantively identical. The companion proposed rule provides the
procedural framework within which the rule may be finalized in the
event the direct final rule is withdrawn because of any significant
adverse comment. The comment period for this direct final rule runs
concurrently with the comment period of the companion proposed rule.
Any comments received in response to the
[[Page 44880]]
companion proposed rule will also be considered as comments regarding
this direct final rule.
FDA is providing a comment period for the direct final rule of 75
days after the date of publication in the Federal Register. If FDA
receives a significant adverse comment, we intend to withdraw this
direct final rule before its effective date by publication of a notice
in the Federal Register within 30 days after the comment period ends. A
significant adverse comment is one that explains why the rule would be
inappropriate, including challenges to the rule's underlying premise or
approach, or would be ineffective or unacceptable without a change. In
determining whether an adverse comment is significant and warrants
withdrawing a direct final rule, the Agency will consider whether the
comment raises an issue serious enough to warrant a substantive
response in a notice-and-comment process in accordance with section 553
of the Administrative Procedure Act (APA) (5 U.S.C. 553).
Comments that are frivolous, insubstantial, or outside the scope of
the direct final rule will not be considered significant or adverse
under this procedure. For example, a comment recommending a regulation
change in addition to those in the rule would not be considered a
significant adverse comment unless the comment states why the rule
would be ineffective without the additional change. In addition, if a
significant adverse comment applies to an amendment, paragraph, or
section of this rule and that provision can be severed from the
remainder of the rule, FDA may adopt as final those provisions of the
rule that are not the subject of a significant adverse comment.
If FDA does not receive significant adverse comment in response to
the direct final rule, the Agency will publish a document in the
Federal Register confirming the effective date of the final rule. The
Agency intends to make the direct final rule effective 30 days after
publication of the confirmation document in the Federal Register.
A full description of FDA's policy on direct final rule procedures
may be found in a guidance document published in the Federal Register
of November 21, 1997 (62 FR 62466). The guidance document may be
accessed at http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.
III. Legal Authority
FDA is issuing this direct final rule under the public health
provisions of the PHS Act. Section 361 of the PHS Act (42 U.S.C. 264)
allows the Secretary of the Department of Health and Human Services to
make and enforce regulations that are necessary ``to prevent the
introduction, transmission, or spread of communicable diseases.''
IV. Environmental Impact
FDA has determined under 21 CFR 25.32(g) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
V. Regulatory Impact Analysis
FDA has examined the impacts of the direct final rule under
Executive Order 12866, Executive Order 13563, the Regulatory
Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct
agencies to assess all costs and benefits of available regulatory
alternatives and, when regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety, and other advantages;
distributive impacts; and equity). The Agency believes that this direct
final rule is not a significant regulatory action as defined by
Executive Order 12866.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. This direct final rule would not affect the ban on
the sale of viable turtle eggs and live turtles with a carapace length
of less than 4 inches. Since it would allow for, but not require, a
change in the disposition of any seized turtles or eggs, it would not
impose any additional compliance costs. Further, it may result in a
small savings to the Agency from reduced investigator training for the
care and humane destruction of these animals. The Agency certifies that
the direct final rule will not have a significant economic impact on a
substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ''any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $141 million, using the most current (2012) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
direct final rule to result in any 1-year expenditure that would meet
or exceed this amount.
VI. Federalism
FDA has analyzed this direct final rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the direct final rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
the Agency concludes that the direct final rule does not contain
policies that have federalism implications as defined in the Executive
order and, consequently, a federalism summary impact statement is not
required.
VII. Paperwork Reduction Act of 1995
This direct final rule contains no collection of information.
Therefore, clearance by OMB under the Paperwork Reduction Act of 1995
is not required.
VIII. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday and will be posted to the docket at http://www.regulations.gov.
List of Subjects in 21 CFR Part 1240
Communicable diseases, Public health, Travel restrictions, Water
supply.
Therefore under the Public Health Service Act and under authority
delegated to the Commissioner of Food and Drugs, 21 CFR part 1240 is
amended as follows:
PART 1240--CONTROL OF COMMUNICABLE DISEASES
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1. The authority citation for 21 CFR part 1240 continues to read as
follows:
[[Page 44881]]
Authority: 42 U.S.C. 216, 243, 264, 271.
Sec. 1240.62 [Amended]
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2. In Sec. 1240.62, remove paragraph (c) and redesignate paragraphs
(d) and (e) as paragraphs (c) and (d), respectively.
Dated: July 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17751 Filed 7-24-13; 8:45 am]
BILLING CODE 4160-01-P