**Purpose of Module for Transport, Movement, and Import:**  This module provides an example template for use in transport, movement, and import that your organization might use as part of your organization’s quality management practices relevant to APHIS regulations found at 7 CFR Part 340 for certain genetically engineered (GE) organisms. 

**Biotechnology Quality Management Support:**  APHIS Biotechnology Regulatory Services has developed this module as one of a series of modules. Biotechnology Quality Management Support is useful for any organization that wishes to develop or improve quality management practices related to the APHIS regulations cited above.

**Approach:**  The module includes a template (below) that your organization can customize specific to your needs and operational practices for transport, movement, and import of regulated GE organisms.  Each section of the template has examples of what might be included in a standardized form for transport, movement, and import.  The template is not a standard, but should be considered as a tool to modify to meet your organization’s needs.  

The example template is found on the APHIS BRS website at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/bqms.  Note that the template text in blue font serves as a prompt for describing your organization’s approach.

**Module:  Transport, Movement and Import**

**Disclaimer:** This module provides a generalized guide for your organization’s quality practices relevant to your obligations under APHIS regulation found at 7 CFR Part 340.  Use of these modules and its content does not guarantee that the user’s activities are in compliance with 7 CFR part 340, and it does not eliminate the user’s obligations under any other statute or regulation.  If your organization wishes to use formal quality management systems, it is best to rely on qualified quality management professionals.

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1.0 **PURPOSE:**This procedure describes the controls your organization uses for transport, movement and import of regulated genetically engineered (GE) organisms; identification of those organisms; the way in which the process is monitored; and whether the monitoring and verification, as well as any changes in those activities, are effective. For example, species of regulated GE organism addressed in this procedure is [species name].

**2.0	DEFINITIONS:**Insert any terms, acronyms or reference to a glossary here that may apply to this procedure.  For the sake of clarity, indicate any deviations in your terminology from the definitions and terms used in 7 CFR part 340.  

**3.0	RESPONSIBILITIES**

**3.1**Identify and record the relevant personnel involved in the transport, movement and import of GE organisms regulated under 7 CFR part 340.  For example, this could be accomplished with an organizational chart or defined directly in the procedure. The level of specificity might identify any quality management representatives, corporate staff, field supervisors, or someone else engaged in the procedures for transport, movement, and import. In some cases, the procedure might require your organization to obtain information from multiple departments according to your organization’s structure (e.g., legal, regulatory) — each of which could be described in this section. 

**4.0	TRANSPORT, MOVEMENT AND IMPORT OF REGULATED GE ORGANISMS PROCEDURE**

**4.1**Describe how regulated GE organisms are physically packaged for transport or shipment in order to maintain containment? For example, describe your organization’s method of ensuring integrity, strength, and durability of shipping containers to withstand rigors of shipping, handling, stacking or dropping.**

**4.2**Describe how regulated GE organisms are tracked from departure to arrival.  For example, you might describe your organization’s possible shippers and respective tracking methods.**

**4.3**	Describe how shipment packages are marked, labeled and identified.  

**4.4**Describe how your organization verifies arrival of regulated GE organisms that are transported or shipped.  For example, describe how the identity of the contents are verified with the shipping record.  Another example might be to describe who inspects the physical packaging to ensure containment integrity, and how this is accomplished?**

**4.5**	Describe how the packaging material is disposed of or returned to use.  For example, describe how your organization’s methods ensure against the unintended release of regulated GE organism, how your organization cleans and inspects packaging material that will be used again, and how any of the methods used by your organization ensure against the unintended release of a regulated GE organism*.*****

**4.6**	Describe how relevant personnel receive training applicable to their defined roles and responsibilities.

**4.7**	Describe how records are kept on all the above activities.

**5.0	REFERENCES**

**5.1**List here any references that your organization uses applicable to this procedure.**

Examples might include: 

Control of Documents

Control of Records

Infrastructure 

List here any records or forms that apply to this procedure.   	Examples might include: 

Master List of Documents Training record(s)

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