United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No.: MDP-SHIP-03 Page 1 of 9

Title: Procedures for Packaging, Shipping, and Archiving Microbiological Cultures

Revision: 05 Replaces: 9/25/2009 Effective: 09/01/2011

1. Purpose

To provide standard procedures to ensure that all shipments of microbial cultures 

isolated by USDA, AMS Microbiological Data Program (MDP) laboratories are 

properly prepared and documented in accordance with applicable U.S. Department of 

Transportation (DOT), U.S. Public Health Service, the Centers for Disease Control 

and Prevention (CDC), and the International Air Transport Association (IATA) 

regulations. To provide destination addresses and contacts as well as shipment 

schedules. To communicate MDP minimum requirements and/or standard procedures 

regarding the shipment and archival of microbiological isolates.

2. Scope

This standard operating procedure (SOP) shall be followed by all laboratories 

conducting microbiological studies for MDP, including support laboratories 

conducting non-routine activities that may impact the program.

3. Outline of Procedures

Shipments by MDP Participating Laboratories.............. 5.1

Packaging Requirements........................................ 5.2

Shipping Requirements.......................................... 5.3

Documentation Requirements.................................. 5.4

Requirements of the Culture Repository..................... 5.5

Shipments by Culture Repository............................. 5.6

Repository Inventory............................................ 5.7

4. References

 2011 Dangerous Goods Regulations. International Air Transport Association 

publication, 52nd edition, Montreal, Quebec, Canada.

 Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). US Department of 

Transportation, Pipeline and Hazardous Materials Safety Administration. 

http://phmsa.dot.gov/portal/site/PHMSA (last accessed 3/11)

 Introduction to Commerce Department Export Controls. Bureau of Industry & 

Security, US Department of Commerce. 

http://www.bis.doc.gov/licensing/exportingbasics.htm (last accessed 3/11)

 Application for Permit to Import or Transport Etiologic Agents, Hosts, or Vectors 

of Human Disease. US Department of Health and Human Services, Public Health, 
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No.: MDP-SHIP-03 Page 2 of 9

Title: Procedures for Packaging, Shipping, and Archiving Microbiological Cultures

Revision: 05 Replaces: 9/25/2009 Effective: 09/01/2011

Centers for Disease Control and Prevention. 

http://www.cdc.gov/od/eaipp/forms/Permit_to_Import_or_Transport_Etiologic_A

gents_Hosts_or_Vectors_of_Human_Diseases_fillable1-17.pdf

 Pro-Lab Diagnostic (MicrobankTM) Storage System, Instructions for Use, Revision 

2005 06.

 SOP MDP-DATA-01, Data Entry, Record Keeping and Results Reporting

5. Procedures

This SOP represents minimum MDP requirements and is presented as a general 

guideline. Each laboratory shall have written operating procedures that provide 

specific details concerning the manner in which the procedures have been 

implemented in that laboratory.

5.1 Shipments by MDP Participating Laboratories

5.1.1 Addresses of destinations are listed in Attachment 01. Addresses for MDP 

participating laboratories are listed in Attachment 02.

5.1.2. Laboratories may be requested to send samples to additional facilities for 

testing. Details regarding the type of sample, the shipping address, and the facility 

point of contact will be provided in writing by the Monitoring Programs Office.

5.1.3 Prior to shipping isolates to the MDP Repository, provide notification via 

email to: achen@agri.ohio.gov and jbalogh@agri.ohio.gov. Attach the Results 

Notification Form, MDP-DATA-01 Attachment 1, Isolate Information Form,

MDP-DATA-01 Attachment 4 (Form 001) and Isolate Shipment Form, MDPSHIP-03, Atch 4, to the notification email. 

5.1.4 For ALL organisms (including E. coli O157:H7), prepare and package 

three Potato-Sucrose agar slants or three Nutrient Agar slants or three Tryptic Soy 

Agar slants per isolate, labeled with the following information:

 Organism type (Salmonella, etc.) 

 Remote Data Entry (RDE) unique number

 Isolation date (date isolate put onto slants for shipping)

 SIF code
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No.: MDP-SHIP-03 Page 3 of 9

Title: Procedures for Packaging, Shipping, and Archiving Microbiological Cultures

Revision: 05 Replaces: 9/25/2009 Effective: 09/01/2011

The three slants and completed Isolate Shipment Form, Attachment 04 of this 

SOP, shall be shipped to the MDP Repository at the following address within five 

(5) business days after isolation: 

Ohio Department of Agriculture Consumer Analytical Laboratory

Building 3, 8995 East Main Street

Reynoldsburg, OH 43068

Clearly annotate on the Isolate Shipment form, Atch 4, that accompanies the slants, 

whether PFGE and serotyping have been completed or if it still needs to be done.

NOTE: Laboratories are encouraged to archive a vial of the isolates in their 

laboratories in case further analysis is required by their State.

 5.2 Packaging Requirements - Each laboratory must comply with all applicable 

federal, state, and international regulations pertinent to the shipment of microorganisms. 

5.2.1 Laboratories shall follow the IATA regulatory requirements for 

classification, documentation, packaging, and labeling of the materials to be 

shipped. Laboratories shall follow the IATA regulatory requirements for 

emergency response procedures and contacts for notification as well as training 

requirements for personnel involved in the preparation of shipments.

5.2.2 The CDC and Department of Transportation do not currently require any 

permit to transport Salmonella, E. coli, or E. coli O157:H7 within the U.S.

5.2.3 If shipping to international destinations, export permits MAY be 

required. The shipper shall notify the intended recipient that their government 

agencies should be contacted regarding needed permits. E. coli O157:H7 has been 

placed on the Department of Commerce’s Control List, requiring a CDC permit 

for international shipments but not domestic shipments. 

 5.2.4 MDP cultures shall be considered infectious bacteria.

5.2.5 MDP laboratories will ship only microorganisms which are classified as 

Biosafety Level (BSL) 2 or lower. 

 5.3 Shipping Requirements

 5.3.1 All shipments shall be handled by a traceable overnight delivery service. 

5.3.2 The Isolate Shipment Form, Attachment 04, shall be completed and 

accompany each shipment. 
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No.: MDP-SHIP-03 Page 4 of 9

Title: Procedures for Packaging, Shipping, and Archiving Microbiological Cultures

Revision: 05 Replaces: 9/25/2009 Effective: 09/01/2011

5.3.3 Slants shall be shipped with adequate packing (bubble wrap, etc.) and/or 

appropriate refrigerant (coldpack or ice) to ensure their integrity during transport.

5.3.4 Other materials (cultures, wash eluate, samples, etc.) shall be shipped as 

specified in section 5.1.2.

 5.4 Documentation Requirements

 5.4.1 RDE documentation requirements reside in SOP MDP-DATA-01.

5.4.2 An internal record shall document the transport for each vial by containing 

the following information:

 Identity of bacterium shipped

 Isolation date (date isolate was put on slants for shipping)

 Quantity shipped in each package, i.e., total volume (ml) or total 

mass size (g) of material in all test tubes and number of such primary 

containers

 Laboratory reference number for the individual culture and sample 

identifier (RDE unique number)

 Date shipped and commercial shipping company used

 Identity of produce from which each bacterium was isolated, and the 

State of origin in the United States, if available

 Shipping conditions used shall be described as ambient temperature, 

ice packs, etc. (specify net weight)

 Printed name of person performing the packaging

 Printed name of person shipping cultures

 The identity of the facility to which each package is shipped and the 

date the receiving laboratory was notified of shipment

 Confirmation of sample receipt

 5.5 Requirements of the Culture Repository

5.5.1 Unless specifically requested by the Monitoring Programs Division (MP), 

the laboratory acting as the culture repository shall not perform analytical 

examinations or verification analyses on the materials sent for archival. 

5.5.2 All isolates shall be archived in MicrobankTM vials and held at -70oC or 

lower, for an indeterminate period of time. 

5.5.3 Labeling of vials: MicrobankTM vials of target organisms shall be identified 

by accessing the Tools section of the RDE system and entering the future 
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No.: MDP-SHIP-03 Page 5 of 9

Title: Procedures for Packaging, Shipping, and Archiving Microbiological Cultures

Revision: 05 Replaces: 9/25/2009 Effective: 09/01/2011

shipment date to the destination(s). (An identification number was automatically 

provided to the originating laboratory by RDE for use in labeling the vials prior to 

shipment to the Repository.) The number generated will consist of the last two 

digits of the calendar year, followed by a dash and the next available number 

consisting of five digits. (i.e. 11-00001) The Repository will insure transfer of the 

RDE number from the slant/shipment documentation to the cryovial prior to 

storage. 

5.5.4 Subculturing Repository Organisms - The laboratory responsible for 

maintaining the repository shall develop and implement internal procedure(s) for 

the recovery and subculturing of organisms. 

 5.6. Shipments by Culture Repository (Ohio Department of Agriculture (ODA) 

Consumer Analytical Laboratory)

5.6.1 Salmonella spp: Within five business days after Salmonella sp. culture 

isolation, one slant of of each isolate received from participating and reference 

laboratories shall be labeled as “MDP-yy-xxxxx”, no spaces (this will become the 

PulseNet key number - Please refer to MDP-DATA-01 SOP, Atch 3, QRG) and 

transfer to the Ohio Department of Health (ODH) for Salmonella serotyping and 

PFGE. Once PFGE and serotyping are completed, ODH/ODA will relay results to 

MP and CDC. Data upload to PulseNet shall be completed within three business 

days of PFGE completion.

5.6.2 E.coli O157: H7: Within five business days after E.coli O157:H7 culture 

isolation, one slant of each isolate received from participating and reference 

laboratories shall be labeled as “MDP-yy-xxxxx”, no spaces (this will become the 

PulseNet key number - Please refer to MDP-DATA-01 SOP, Atch 3, QRG) and 

transfer to the ODH for PFGE. Once PFGE is completed, ODH/ODA will relay 

results to MP and CDC. Upload to PulseNet for E.coli O157:H7 isolates shall be 

completed within three business days after completion of PFGE. The MDP 

Repository will also ship an E.coli O157: H7 isolate slant to Pennsylvania State 

University (PSU) for further characterization. PSU will report its test results to 

the MDP Repository and MP. The information from PSU shall also be uploaded 

to PulseNet. 

5.6.3 Non-O157 STEC: Within five business days of receipt of non-O157 STEC 

isolates from participating and reference laboratories, the isolates shall be labeled 

as “MDP-yy-xxxxx”, no spaces (this will become the PulseNet key number -

Please refer to MDP-DATA-01 SOP, Atch 3, QRG) and one isolate slant shall be 
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No.: MDP-SHIP-03 Page 6 of 9

Title: Procedures for Packaging, Shipping, and Archiving Microbiological Cultures

Revision: 05 Replaces: 9/25/2009 Effective: 09/01/2011

shipped to PSU for further characterization and one isolate slant transferred to 

ODH for PFGE. PSU will report its test results to the MDP Repository and MP. 

Within two business days of receipt of the results from PSU, the Repository shall 

relay PSU results to ODH so that the PulseNet record for the particular isolate 

shall be updated. Once PFGE and upload is completed, ODH/ODA will notify 

MP and CDC. 

5.6.4 For all isolates: ODA/MP will be responsible for populating the repository 

database with information. (Repository database has been placed on MP

Extranet). The repository may ship isolates of appropriate number and type of 

slants to other facilities as requested in writing by MP.

5.7 Repository Inventory - The repository inventory database may be manual, 

electronic or a combination of both. At a minimum, the inventory control system 

must document:

 Unique RDE number

 Laboratory ID

 Organism

 MDP lab/commodity

 SIF code

 Isolation Date (date isolate was put on slants for shipping)

 Date received by ODA

 Transfer date to ODH

 Transfer date to PSU

 Date frozen/location

 PFGE result

 Serotyping result

 ETEC/STEC results

 Comments (outbreak related, recall, etc.)

Disclaimer: Reference to brand names (kits, equipment, media, reagents, etc.) does not 

constitute endorsement by this agency.
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No.: MDP-SHIP-03 Page 7 of 9

Title: Procedures for Packaging, Shipping, and Archiving Microbiological Cultures

Revision: 05 Replaces: 9/25/2009 Effective: 09/01/2011

Mary Tijerina 22 June 2011

_____________________________________________________________

Revised by: Mary Tijerina Date

Microbiologist, Microbiological Data Program

8609 Sudley Road, Suite 206, Manassas, VA 20110

(703) 330-2300 x111

Maya Achen 27 June 2011

_____________________________________________________________

Reviewed by: Maya Achen Date

Chairperson, MDP Technical Advisory Group

Ohio Department of Agriculture Consumer Analytical Laboratory

Bldg 3, 8995 E Main Street, Reynoldsburg, OH 43068

(614) 728-2790

Shanker Reddy 6 July 2011

_____________________________________________________________

Reviewed by: Shanker Reddy, PhD Date

Molecular Biologist, Microbiological Data Program

8609 Sudley Road, Suite 206, Manassas, VA 20110

(703) 330-2300 x135

Diana Haynes 7 July 2011

Approved by: Diana Haynes Date

Deputy Director, Monitoring Programs Division

8609 Sudley Road, Suite 206, Manassas, VA 20110

(703) 330-2300 x134

ELECTRONICALLY REPRODUCED SIGNATURES - ORIGINAL SIGNATURE PAGE MAINTAINED BY USDA, AMS, S&T, MONITORING PROGRAMS 

OFFICE
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No.: MDP-SHIP-03 Page 8 of 9

Title: Procedures for Packaging, Shipping, and Archiving Microbiological Cultures

Revision: 05 Replaces: 9/25/2009 Effective: 09/01/2011

Revision 05 May 2011 Monitoring Programs Division

 Add words “shipment and” to last sentence of Section 1

 Added Outline of Procedures, Section 3

 Updated References, Section 4

 Revised old Section 4.1.3 (new 5.1.3) by adding “Attach the Results Notification 

Form, MDP-DATA-01 Attachment 1 and the Isolate Information Form, MDPDATA-01 Attachment 4 (Form 001) to the notification email.” 

 Revised old Section 4.1.3 (new 5.1.4) by changing (in bold) “For ALL organisms 

(including E. coli O157:H7), three Potato-Sucrose agar slants or three Nutrient 

Agar slants or three Tryptic Soy Agar slants per organism, labeled with:

o Organism type (Salmonella, etc.) 

o Remote Data Entry (RDE) unique number

o Isolation date (date isolate put onto slants for shipping)

o SIF code

The three slants and completed MDP Shipment Form, Attachment 04 of this 

SOP, shall be shipped to the MDP Repository at the following address within 

five (5) business days after isolation: 

Ohio Department of Agriculture Consumer Analytical Laboratory

Building 3, 8995 East Main Street

Reynoldsburg, OH 43068

Clearly annotate on the shipment form that accompanies the 

slants, whether PFGE and serotyping have been completed or if it 

still needs to be done.”

 Replaced the word “import” with “export”, Section 5.2.3

 Revised old Section 4.6. (new 5.6) (subsection changes in bold type) to read as:

“5.6.1 ....Once PFGE and serotyping are completed, ODH/ODA will relay 

results to MP and CDC....”

“5.6.2 .... Within five business days after E.coli O157:H7 culture isolation, one 

slant of each isolate received .... Once PFGE is completed, ODH/ODA will relay 

results to MP and CDC. Upload to PulseNet for E.coli O157:H7 isolates shall be 

completed within three business days after completion of PFGE. The MDP 

Repository will also ship an E.coli O157: H7 isolate slant to Pennsylvania 

State University (PSU) for further characterization. PSU will report its test 

results to the MDP Repository and MP. The information from PSU shall also 

be uploaded to PulseNet.”

 Added new subsections 5.6.3 and 5.6.4
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No.: MDP-SHIP-03 Page 9 of 9

Title: Procedures for Packaging, Shipping, and Archiving Microbiological Cultures

Revision: 05 Replaces: 9/25/2009 Effective: 09/01/2011

 Revised Attachment 01, Shipment Destinations

 Revised Attachment 02, Shipment Addresses

 Revised Attachment 03, Shipment Flowchart

 Revised Attachment 04, MDP Isolate Shipment Form

Revision 04 September 2009 Monitoring Programs Office

 Updated References, Section 3

 Revised Sections 4.1 through 4.7

 Revised Attachment 1

 Revised Attachment 2

 Revised Attachment 3

Revision 03 March 2009 Monitoring Programs Office

 Updated Outline of Procedures

 Updated References

 Updated Shipments by MDP Participating Labs

 Updated Requirements of the Culture Repository

 Updated Shipments by Culture Repository

 Updated Attachments

Revision 02 January 2006 Monitoring Programs Office

 Removed shipment of vials for mPCR testing

 Updated addresses and added alternate contact person for shipping destinations.

 Added allowance for specific MP request for additional testing on isolates by 

archival laboratory

Revision 01 October 2004 Monitoring Programs Office

 Updated references

 Removed revision numbers from attachments

 Corrected Attachment 01