Guidelines for Preparing Export License Applications for Chemical and Biological Items

I. Introduction

The Chemical & Biological Controls Division has prepared this guide for exporters to use in submitting license applications involving chemical and biological items. You are encouraged to follow these guidelines to assist us in processing your license application more efficiently. Due to regulatory time limits for processing license applications, it is in the interest of each exporter to provide all information needed to analyze the transaction when the application is submitted.

II. Basic Information

In addition to the instructions for filling out a license application, we recommend the following when completing the form.

CONTACT INFORMATION: Provide the telephone extension of the person to be contacted and any other people authorized to be contacted regarding the export license application in the Additional Information Section (Block 24).

NAMES and ADDRESSES:

  1. No acronyms- If the name of the party is too long to fit into the allowed spaces – spell out as much of the name as possible and then provide the complete name in the Additional Information Section (Block 24).
  2. No P.O. Box numbers – need a physical address
  3. Provide English translations of names.

END USERS: For chemical & biological items, we need the final end users. Distributors can be identified as the ultimate consignee or as additional end users and provide a detailed explanation of the transaction in the Additional Information Section or attach a Letter of explanation

END USE: Provide exact description of the end-use. For example, “for research purposes” is not sufficient. Explain the nature of the research. Provide information about the appropriateness of the item for the end-use.

COMMODITY DESCRIPTION: Provide the technical characteristics of the item as noted in the ECCN. For example, valves ranging from 1 to 3 inches made from PTFE.

ADDITIONAL INFORMATION Provide additional background on persons and/or institutions involved in the end-use. Please list support documents included in the application such as MOFCOMS, business licenses, etc.

III. Technical Information

Be sure to include the information listed below for each commodity in either the commodity description or end use section.

1. Chemical Precursors (1C350, 1C355, 1C395)

* Name of chemical or mixture

* Chemical Abstract Service Registry (C.A.S.) numbers

* Quantity in “kilograms” only

* Statement about the reasonableness of quantity requested

* Weight percentage of each chemical (if a mixture) (Total weight percentof ingredients in the mixture must add up to 100%) Note: The Manufacturers Safety Data Sheet (MSDS) is not often acceptable because it does not disclose the proprietary input required for evaluation.

If the chemical is to be used in manufacturing an end-product, include:* Input/output ratio of the controlled chemical to the end-product

2. Microorganisms and Toxins (1C351, 1C352, 1C353, 1C354, 1C360, 1C991)

* Any alternative names for the organism: For example, Variola virus is thesame as smallpox, Lyssa virus is the same as rabies.

* A summary of current research activities of the institution when the organism is intended for use in research.

* For individual researchers, place the name of the institution or university where the product is to be delivered in the Ultimate Consignee or end user block. Provide the researcher’s name, date & place of birth, academic background, work experience, summary of research history, and recent publications in the Additional Information section – do not place an individual’s name in the Consignee or End user block.

* Identify the specific department in which the item will be used, i.e., biology,pathology, radiology, etc in the End Use block.

3. Chemical and Biological Equipment (2B350, 2B351, 2B352)

* Specific type of equipment as defined in Category 2 of the Commerce Control List, Export Control Classification Numbers 2B350, 2B351 and 2B352

* Technical parameters to describe the equipment in terms of the ECCN For example, for reactors controlled under ECCN 2B350 include their “total internal (geometric) volume.”

* Surface materials that come into direct contact with chemicals, i.e., nickel, glass, zirconium, etc.

4. Technical Data and Software Related to Chemicals and Chemical and Biological Equipment (1E001, 1E351, 2E001, 2E002, 2E301)

* Process flow chart for the main processing stages

* Description of manufacturing process relating to the flow chart

* Equipment, control systems and raw materials used in the process

* Output capacity of manufacturing plant

* Description of technical assistance and training of foreign nationals,

* Safeguards to prevent diversion of both the technology and the direct product to chemical or biological weapons use

IV. Special Considerations

* Describe any special funding source, such as an international institution, i.e., World Health Organization, DTRA, etc.

* Indicate if the end-user is a U.S. subsidiary or a joint venture, or if there is some other relationship with the exporter, i.e., periodic servicing or on-site visitation.

* Provide information on licensing history, i.e., approvals, denials, RWA’s and the reasons for RWA’s.

* For items classified under EAR99, indicate the reason why the application is being submitted.

V. Application Checklist

* Double check your Export Control Classification Number (ECCN) determination and number.

* Review your application carefully to ensure that requirements in Sections II and III above have been met.

* Are the quantities and dollar values correct?

* Have you properly noted supporting documentation ?

* Have you described the specific end-use in detail?

* Have you identified all end-users and provided appropriate background information?

* Include a letter of explanation if additional information is needed to adequately describe the transaction.