Guidelines for preparing export license applications for chemical and biological items
I. Introduction
The Chemical and Biological Controls Division has prepared this guide for exporters to use in preparing license applications involving chemical and biological items. You are encouraged to follow these guidelines to assist BIS 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 in Part 748 of the EAR, we recommend the following guidelines when completing the application.
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
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).
Regulation does not permit P.O. Box numbers. BIS requires a physical address
Provide English translations of party names, and English translations for valid business certificates along with the native language copy.
End-users
For chemical and biological items, applicants should list the final end-user(s). Distributors can be identified as the ultimate consignee or as additional end-users. If distributors are identified as additional end-users or as the ultimate consignee, please provide a detailed explanation of the transaction in the Additional Information Section or attach a Letter of Explanation.
End-use
Provide a detailed description of the end-use. For example, “for research purposes” or “liquid handling” are not sufficient end use statements. Explain the nature of the research or name the materials the export items will be processing. Provide information about the appropriateness of the item for the end-use.
Commodity description
Provide a technical specification sheet highlighting the technical characteristics of the item as noted in the ECCN. For example, for valves list the following in the technical description and in the technical specification sheet:
Wetted components (i.e., components that come into contact with the fluid being processed (e.g., valve body, liner, closure element)) and their materials of construction. For materials, please use full chemical names. For alloys, please specify 100% elemental composition.
Nominal valve size in inches.
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, valid business licenses/certificates, 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 (names of the active ingredients in the mixture)
Chemical Abstract Service Registry (C.A.S.) numbers
1C3350 Technical Note #3: Precursor chemicals in ECCN 1C350 are listed by name, Chemical Abstract Service (CAS) number and CWC Schedule (where applicable). Precursor chemicals of the same structural formula (e.g., hydrates, isotopically-labeled forms or all possible stereoisomers) are controlled by ECCN 1C350, regardless of name or CAS number. CAS numbers are shown to assist in identifying whether a particular precursor chemical or mixture is controlled under ECCN 1C350, irrespective of nomenclature. However, CAS numbers cannot be used as unique identifiers in all situations because some forms of the listed precursor chemical have different CAS numbers, and mixtures containing a precursor chemical listed in ECCN 1C350 may also have different CAS numbers.
For example: Sodium Sulfide Nonahydrate (CAS #313-84-4), a hydrate of Sodium Sulfide, (1C350d.48; CAS# 1313-82-2), is controlled under 1C350.
Unit of measure in “kilograms” only
Statement about the reasonableness of quantity requested
Weight percentage of each chemical (if a mixture) (Total weight percent of ingredients in the mixture must add up to 100%) Note: The Manufacturers Safety Data Sheet (MSDS) is not often sufficient because it does not disclose the proprietary input required for evaluation.
Provide detailed end use of the export item: what chemicals are being processed and what is the final end product(s), Input/output ratio of the controlled chemical to the end-product.
Provide End-Use Certificate for exports of Schedule 3 chemicals to countries not listed in Supplement No. 2 to part 745 of the EAR.
2. Microorganisms and Toxins (1C351, 1C353, 1C354, 1C991)
In the ‘Units’ block, indicate vial, weight (mg, ug) or volume (mL, uL); ‘EACH’ is not acceptable ‘Units’ in most cases. You may add number of vials X mass or volume/vial = Total quantity.
Ensure the item description clearly names the toxin, microorganism or genetic element (and source organism). For example, ‘1C353 plasmid containing genetic elements from the 1C351 controlled rabies virus’.
Any alternative names for the organism: For example, Variola virus is the same 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. This may include example publications from the institution.
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 unless applying for a Deemed Export license. For additional requirements and information on Deemed Exports, please see Deemed exports and fundamental research for biological and chemical items.
Identify the specific department in which the item will be used, i.e., biology, pathology, radiology, etc. in the End-Use block. Specific laboratories within the department should be noted in “Additional information”.
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. Deemed export/re-export license application: 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
A detailed description of manufacturing process and application for the technology
Technology control plan - Equipment, control systems and raw materials used in the process
The form in which the technology will be released
The address where the technology will be released
Output capacity of manufacturing plant
Description of technical assistance and training of foreign nationals,
Safeguards and training to prevent diversion of both the technology and the direct product to chemical or biological weapons use
Copies of passport, visa, work-authorization and resume of the foreign individual
IV. Special considerations
Describe any special funding source, such as an international institution, i.e., World Health Organization, DTRA, foreign government, 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. If this is a resubmission of an RWA-ed license, please be sure to address the reason it was RWA-ed and provide the requested information or explanation.
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.
Double check all spellings and addresses and make sure address is correct.
Review your application carefully to ensure that requirements in Sections II and III above have been met.
Are the quantities and dollar values correct? BIS cannot accept a dollar value of ‘0’.
Have you properly noted supporting documentation?
Does the supporting documentation match the application? (Correct parties on business certificates, correct items, values and parties in MOFCOM certificates, correct technical specification sheets, etc)
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.