ZeptoMetrix Corporation
Export Compliance
Program Design and Implementation
 Business Review and Capability Assessments (Internal vs.
External)
 Mandated Requirements for Exporting Companies
 Manual Design and Integration with Current Quality
System, (ISO 13485 / QSR cGMP)
 Define Employee Roles and Responsibilities
 Employee Training and Review
 Monitoring and Continual Improvement
ZeptoMetrix Corporation
Business Review
 ZMC is a fully integrated biotechnology company that
services diagnostic and pharmaceutical companies
worldwide
 Company manufactures raw materials and diagnostic
kit components used by scientists to develop testing kits
and also products to maintain their quality control
 Company ships biological materials, inactivated
organisms, test kits and other related diagnostic
products
United States Export Compliance
Requirements
 Appropriate Export Commodity Jurisdiction
 Dept. of Commerce (BIS) v. Dept. of Defense (DTC)
 Overlapping and intersecting export controls
 Primary: Export Administrative Regulations (EAR), Dept. of
Treasury (OFAC); Foreign Trade Regulations (FTR), Dept. of
Defense through ITAR
 Know your product/service---see where it fits in the export
regulatory scheme
 There is no substitute for reading and cross-referencing
those regulations applicable to your product and industry
to understand your export responsibilities.
Manual Design
 Design Manual with focus on integration into Current Quality
System
 Manual should be written for hands on use, not as a show
piece for auditors
 Operations & Legal were the key drivers of the compliance
development process.
 Staff from various affected departments were consulted as needed
 Delegate revision responsibilities; maintained one working draft
 Research and determine which US regulations are appropriate
to your business
 Identify key positions within the company that will play a role
in Export Compliance (organizational chart)
 Develop process maps to include Export Compliance into
current company activities
Export Compliance Manual Sections
1. Export Management System Summary

Policy Statement; Scope of EAR
2. Administrative Elements

Responsibilities; Record Keeping; Training
3. Order Processing System


Flowcharts for New Customer Set-up, Order Process, & Export
Compliance Officer Decision Tree
Narrative indicates where to screen, “hold” an order, and instructions
for resolving a “hold”
4. Export Licensing Requirements

Product Commodity Classification Process
5. Export Licensing Requirements

Restricted End-Uses and End-Users
6. Export Clearance
7. Appendices 1 – 19
ZMC Export Compliance Requirements
 Dept of Commerce: BIS, subject to EAR (15 CFR 730 et seq)
 ZMC products are intended for commercial use, some capable of
military application: “Dual-Use”
 “General Prohibitions” of EAR are applied to all
ZMC Product Orders:




Restricted End-Users, End-Uses, Embargoed Countries
Red Flags and Anti-boycott Provisions
Identify those ZMC Products on the CCL that require export licenses
Special attention paid to those regulations dealing with Chemical and
Biological Weapons
Organization Chart
Order Process Flowchart
New Customer Set-up Flowchart
Employee Roles and Responsibilities
 Operations
 Lead Export Compliance planning and design meetings
 Process map new export requirements into current
operations and optimize current system where
appropriate
 Legal
 Conduct research and generate draft Export
Compliance Manual applicable to ZMC business
focus
 Work with Operations to streamline processes :
minimize workflow interruption while staying export
compliant
 Assists in implementing and updating export
compliance program
Employee Roles and Responsibilities
 Regulatory/Quality Assurance
 Design new /modify existing standard operating
procedures to integrate export compliance requirements
 Implementation and training of new procedures
 Monitoring and continual improvement
 Act as on-site Export Compliance Officer
 Scientists
 Assess new ZMC Products against Commerce Control
List (CCL) for ECCN
 Update MRP /database system with code for each new
product with ECCN; inform Export Compliance Officer
 Prepare technical description of ZMC Products with
ECCN for BIS license application
Employee Roles and Responsibilities
 Sales
 New Customer Approval and set-up in billing system
 Screen initial ZMC product inquires for “Red Flags” and
Anti-boycott compliance
 Process Orders: screen for restricted users/uses and
whether product requires BIS export license due to ECCN
designation
 Marketing
 Update of company literature and website with Export
Disclaimers
Employee Roles and Responsibilities
 Distributors
 Define processes for ZMC products with ECCN
 Letter of commitment for following US Export
Regulations
 Shipping / Receiving
 Screen each order against restricted uses/users, Red Flags
and embargo lists –e.g. “Shipping Solutions” software
 Apply for BIS licenses when required
 Appropriate labeling and packaging
 Maintain shipping records in accordance with applicable
government regulations
Employee Training and Review
 Identify Departments that require training (org chart)
 Set up initial training sessions
 Document compliance with written tests and keep on file
with other employee training records
 Troubleshoot system with various go, no-go situations
 Monitor for continual improvement
Monitoring and Continual Improvement
 Conduct annual training meeting for updates to export
compliance
 Export Compliance Officer and Legal are enrolled with
BIS for regulatory updates via email
 Annual Audits by Export Compliance Officer
 New Customer Records, Outbound Shipment Records, Employee
Training Records
 Review/amend where necessary standard operating procedures
that include export compliance components
Challenges
 Complexity of Export Compliance: Resources
 (1) BIS website: “Compliance Guideline: How to Develop
an Effective Management and Compliance Program and
Manual”
http://www.bis.doc.gov/complianceandenforcement/emcp_
guidelines.pdf; see training modules, seminars, contacts
 (2) EAR and related export regulations on-line
 (3) Professional Organizations: e.g. Tradewin, Association
of Corporate Counsel, Law Libraries: white papers, forms,
seminars, consulting
 (4) Massachusetts Export Center: consult and assistance
Challenges
 Streamlining Export Compliance
 Understand export requirements well enough so that you can integrate
compliance measures without strangling business efforts
 Examples:
 (1) Sell ZMC Products with ECCN directly, not through distributors—
limit liability and processing time for license
 (2) Only code/document those Products with ECCN—not all ZMC
Products
 (3) Export Screening Software; expedite Export Compliance Officer
review of positive screenings
 (4) Company policy: do not bother with applying for license where have
verified positive screening for a restricted end-user, end-use, embargoed
country
 (5)Standardize forms: e.g. Product Commodity Classification, Customer
Profile, Distributor Letters
 New Export Compliance Regime Anticipated
ZeptoMetrix Corporation
Contact Information
878 Main Street
Buffalo, NY 14202
(800) 274-5487
(716) 882-0920
(716) 882-0959 (FAX)
Elise S. Nulton
enulton@zeptometrix.com
25 Kenwood Circle
Suite 6
Franklin, MA 02038
(866) 520-0588
(508) 553-5800
(508) 520-1525
John Paul
jpaul@zeptometrix.com
www.zeptometrix.com