[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

0
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]

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. 2013-17751 Filed 7-24-13; 8:45 am]
BILLING CODE 4160-01-P