BACKGROUND:

Turtles may carry Salmonella genus (including Salmonella arizona strains) bacteria and may transmit these bacteria to humans, causing salmonellosis. Salmonellosis is characterized by severe gastrointestinal symptoms (abdominal pain, nausea, fever, and diarrhea) and occasionally results in death.

POLICY:

The sale or commercial distribution of viable turtle eggs and small turtles (carapace length less than 4 inches) for use as pets is banned under 21 CFR 1240.62. The ban is based on the Public Health Service Act (section 361, 58 Stat. 703) and therefore applies to both intrastate and interstate sale and distribution. Exceptions to the ban under 21 CFR 1240.62 permit sales of turtles and turtle eggs for use in bona fide scientific, educational, or exhibitional purposes other than as pets and of marine (ocean) turtles. Other exceptions to the ban are the sale of turtles and turtle eggs not in connection with a business (e.g., limited sales between turtle fanciers have been permitted) or that are intended only for export. The ban applies to small turtles (under 4 inch carapace length) because these are most likely to be held for sale as children's pets, and the purpose of the ban is to protect children from turtle-born salmonellosis.

FDA will respond to consumer and state and local government complaints. If illegal turtles are encountered during the course of regular FDA activities appropriate action should be taken. If illegal pet turtles are found in distribution channels, the following are recommended:

1. Determine whether the State or local government has regulations controlling turtles. If so, they should be encouraged to assume primary responsibility and report the source or subsequent distribution of the turtles outside their jurisdiction to FDA for appropriate followup. If a State or local government is unable or unwilling to take appropriate action, FDA will assume primary responsibility for the investigation.

2. Advise the person or persons who are offering for sale, or other commercial distribution, turtles with a carapace length of less than four (4) inches in length or viable turtle eggs, that they are in violation of 21 CFR 1240.62. Provide a copy of the regulations to the person in charge.

3. Determine, if possible, the source and subsequent distribution of illegal turtles. Send surveillance reports to the home districts of the turtle suppliers and distributors and report sub-distribution so that followup may be made to effect removal of turtles from distribution. Also, report purported &quotlegal"distribution under the exceptions listed in 21 CFR 1240.62 (e.g., shipments to pet stores invoiced as &quotfor scientific purposes") so that investigations can be made of diversions to pet sales.

4. Encourage appropriate voluntary disposition whenever possible (see paragraph 6).

5. If voluntary disposition cannot be obtained, issue a Demand for Disposition letter. If sale or distribution of turtles or turtle eggs in violation of 21 CFR 1240.62 has already been documented by a State or local government agency, the Demand for Disposition letter may be issued on that basis. (For a guide for preparation of the Demand for Disposition letter see Attachment A.) After service of the Demand for Disposition, take all reasonable precautions to insure that the person in possession of the turtles or turtle eggs will not sell, distribute, or otherwise dispose of any of the turtles or turtle eggs except in a manner that precludes children obtaining the turtles.

6. Any reasonable voluntary or on-demand method of disposition that accomplishes the goal of removing small turtles from general sale, or distribution is acceptable (e.g., donation to a zoo). The Humane Society may be willing to supervise release to the wild in an appropriate habitat. Destruction of the turtles by FDA personnel at the district office using a humane method is indicated if an acceptable alternative method of disposition is not available. Because turtles are &quotcold blooded,"freezing is a humane method of destruction.

7. Following destruction, the turtles should be disposed of in a manner to preclude spread of any contaminating organism.

8. Forward a copy of the investigation (including the source, any subsequent distribution and disposition) to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*.

REGULATORY ACTION GUIDANCE:

If a dealer refuses to comply after receiving the Demand for Disposition letter (Attachment A), and evidence is obtained that turtles continue to be held for sale or distribution in violation of 21 CFR 1240.62, *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* should be contacted before submission of a regulatory action proposal.

GUIDE LETTER FOR DEMAND FOR DISPOSITION

On June 1, 1983, FDA investigator Jones inspected (insert name of organization, company, person, or persons).

The inspection showed that turtles were being offered for sale or public commercial distribution (recite with particularity the facts which justify the demand).

Pursuant to the Code of Federal Regulations, Title 21, section 1240.62, a copy of which is attached, demand is made that these turtles shall not be sold, distributed or otherwise disposed of except by an approved method of disposition (e.g., destruction by a humane method such as by freezing, release to the wild, or donation to a zoo) by or under the Supervision of the ____________ District of the Food and Drug Administration.

You may comply with this demand for disposition or within 10 working days appeal the demand to the Director of the *Center for Food Safety and Applied Nutrition*, Food and Drug Administration, 200 C Street, S.W., Washington, DC 20204. Such manner of appeal is described in section 1240.62(c) of the attached regulation (21 CFR 1240.62). Please contact _________________ at (telephone No.) to arrange for supervision of the disposition of the turtles.

/s/

District Director

*Material between asterisks is new or revised*

Issued: 5/1/84

Revised: 8/31/89, 3/95

Model Certificate for Export

The U.S. Food and Drug Administration certifies for [COUNTRY] the following information concerning the product listed below manufactured or distributed by [NAME OF COMPANY], [ADDRESS]:

PREMARKET APPROVAL IDENTIFIER (IF APPLICABLE, I.E., NDA, NADA, PMA NUMBER, 510(k) Number)

The product (and the plant which produces it) described above are subject to the jurisdiction of the Food and Drug Administration.

It is certified that the above listed product may be freely marketed in, or may otherwise be exported, from the United States of America at this time.

The manufacturing plant in which the products are produced is subject to periodic inspections, and the last such inspection showed that the plant, at that time, appeared to be in compliance with current Good Manufacturing Practice (GMP) required by the Federal Food, Drug, and Cosmetic Act.

Signature

Title

Food an Drug Administration

_____________________________________________________________________________________________

Country of _________________

State of _________________

Subscribed and sworn to before me this _________________ day of _________________.

APPENDIX 2 - EC EXPORT HEALTH CERTIFICATE

CERTIFICATE NO. _________________

HEALTH CERTIFICATE

Covering fishery products for import into the European Community.

Country of dispatch: __________________________________

Competent authority (1): __________________________________

Inspection body (1): ____________________________________________________

Reference number of health certificate: __________________________________

1. Details identifying the fishery products

Description

- Species (scientific name) __________________________________

- State (2) or type of processing __________________________________

Type of packaging: __________________________________

Number of packaging: __________________________________

Net Weight: __________________________________

Temperature required during storage and transport:_____________________________

2. Provenance of the fishery products

Address(es) and number(s) of preparation or processing establishment(s) authorized for exports by the competent authority: _______________________________________________________________________

3. Destination of the fishery products

The fishery products are to be dispatched from :__________________________________________________

(Place of dispatch)

to:__________________________________________________________________________________

(Country and place of destination)

by the following means of transport:__________________________________________________________

Name and address of consignor:_______________________________________________________________

Name of consignee and address at place of destination: __________________________________________

Signature:__________________________________ Date:__________________________________

4. Health Attestation

The undersigned official inspector hereby certifies that:

1. The fishery products above have been handled, prepared or processed, identified, stored and transported under conditions at least equivalent to those laid down in Council Directives 91/493/EC of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products.

2. In addition, in the case of frozen or processed bivalva mollusks, the latter have been gathered in production areas subject to conditions at least equivalent to those laid down in Council Directive 91/492/EC of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve mollusks.

Done at __________________________________ on __________________________________

(Place) (Date)

__________________________________

Signature of Official Inspector

__________________________________