[Federal Register Volume 78, Number 143 (Thursday, July 25, 2013)]
[Proposed Rules]
[Pages 44915-44917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17752]


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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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
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 would reduce the need for investigator 
training and the time for the care and humane destruction of these 
animals.

DATES: Submit either electronic or written comments by October 8, 2013. 
If FDA receives any significant adverse comments, the Agency will 
publish a document withdrawing the direct final rule within 30 days 
after the comment period ends. FDA will then proceed to respond to 
comments under this proposed rule using the usual notice and comment 
procedures.

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 Sec.  1240.62 (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

[[Page 44916]]

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 proposing to amend 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 would 
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 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 would retain 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 proposed 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. Those provisions of the regulations would remain in effect. 
Violators would still be 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 (the PHS 
Act) (42 U.S.C. 271).

II. Companion Document to Direct Final Rulemaking

    This proposed rule is a companion to the direct final rule 
published elsewhere in this issue of the Federal Register. FDA proposes 
to amend Sec.  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 proposed 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 
direct final rule. The direct final rule and this companion proposed 
rule are substantively identical. This 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 proposed rule runs 
concurrently with the comment period of the companion direct final 
rule. Any comments received in response to the companion direct final 
rule will also be considered as comments regarding this proposed rule.
    FDA is providing a comment period for the proposed rule of 75 days 
after the date of publication in the Federal Register. If FDA receives 
a significant adverse comment, we intend to withdraw the 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 (5 U.S.C. 553).
    Comments that are frivolous, insubstantial, or outside the scope of 
the proposed 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 proposed rule would not be considered a 
significant adverse comment unless the comment states why the proposed 
rule would be ineffective without the additional change. In addition, 
if a significant adverse comment applies to an amendment, paragraph, or 
section of this proposed rule and that provision can be severed from 
the remainder of the rule, FDA may adopt as final those provisions of 
the proposed rule that are not the subject of a significant adverse 
comment.
    If FDA does not receive significant adverse comment in response to 
the proposed 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 proposed 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. Preliminary Regulatory Impact Analysis

    FDA has examined the impacts of the proposed rule under Executive 
Order

[[Page 44917]]

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 proposed 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 proposed 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 could result in a small 
savings to the Agency from reduced investigator training for the care 
and humane destruction of these animals. The Agency proposes to certify 
that the proposed rule if finalized would 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 
proposed rule to result in any 1-year expenditure that would meet or 
exceed this amount.

VI. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized, would 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 tentatively concludes that the proposed 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 proposed rule contains no collection of information. 
Therefore, clearance by the Office of Management and Budget 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, it is proposed that 21 
CFR part 1240 be amended as follows:

PART 1240--CONTROL OF COMMUNICABLE DISEASES

0
1. The authority citation for 21 CFR part 1240 continues to read as 
follows:

    Authority:  42 U.S.C. 216, 243, 264, 271.


Sec.  1240.62  [Amended]

0
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. 2013-17752 Filed 7-24-13; 8:45 am]
BILLING CODE 4160-01-P