FDA Import Operations Initiative-Opportunities & Challenges For Trade

1. FDA Import Operations Initiative-Opportunities & Challenges For Trade Roger Clarke Williams Clarke Company, Inc. President rclarke@williamsclarke. com website: http://www.williamsclarke.com Chairman, Los Angeles Customs Brokers and Freight Forwarders Association Inc. Director & Regulatory Agency Committee Chair National Customs Brokers & Forwarders of America, Inc.

2. PCC Expands To Other Government Agencies • PCC leadership and Board recognizes the increasing role of other government agencies beyond CBP • In April a new PCC Participating Government Agency (PGA) Committee was formed • Ms. Maggie Smith-Ranney assumed leadership of the new committee. • One additional representative from each of the PCC member Association make up the committee.

3. PCC Expands To Other Government Agencies • The PGA Committee will start to address FDA uniformity issues between the five FDA Offices of Import Operation and the three West Coast FDA Districts • The PCC PGA Committee to work with the five member local Associations PGA Committees to help resolve regional issues. • The PCC PGA Committee will coordinate with other regional associations and the NCBFAA Regulatory Agency Committee in working with FDA to increase the level of public health and safety

4. NCBFAA Regulatory Agency Reformed • Mr. Jeff Coppersmith, upon assuming the leadership of the NCBFAA asked Mr. Roger Clarke to assume leadership and reform the NCBFAA Regulatory Agency Committee (RAC) • The RAC was reformed with one participating member from each of the 9 NCBFAA Areas. • Ms. Maggie Smith-Ranney was also asked to participate in the new RAC representing the PCC • The RAC holds monthly phone conference call meetings

5. NCBFAA Regulatory Agency Reformed • Various PGA representatives are asked to participate in the calls to address specific agenda items related the their specific agency • RAC discussions with FDA on specific issues • Files inability to alter or correct the CBP MID database also used for FDA identification purposes • Definition of FDA ultimate consignee as compared to CBP historical interpretation • Use of the FDA Firm Establishment Identifier (FEI) • Regulatory informed and enforced compliance for filers

6. NCBFAA Regulatory Agency Reformed • RAC current projects being worked on • Multiport FDA import operation contact list • Review local FDA import operations to help isolate both problem issues and also identify good practices • Help develop an FDA Binding Ruling System • Develop closer ties with local association through the NCBFAA Associated President Network (APN) for port specific information • Work with the NCBFAA Educational Institute to present webinars on PGA procedures

7. FDA Import Operations-A New Paradigm For The Future • FDA is faced with an ever increasing range and complexity of imported regulated products • Recognizing import inefficiencies and uniformity issues FDA is taking a top to bottom review of their import activities and operations. • FDA developing a nationwide Import Operations Strategic Plan • FDA internal Task Force on Transparency formed

8. FDA Import Operations-A New Paradigm For The Future • FDA secures Bottom-line Solutions Inc. to conduct a survey on import operations • Internal FDA management and employees interviewed • Contacted other Government agencies for comments and suggestions • Approached other stakeholder for input from the trade side • The NCBFAA was asked to make comments and suggestion on current issues, future approach for import operations, and how trade envisions the agency should move in the future

9. FDA Import Operations-A New Paradigm For The Future • The NCBFAA RAC, with input from the PCC PGA Committee developed a 5 page comment document containing 30 import operations issues our industry felt needed to be reviewed such as • Uniform means of communications • Timely response time to queries • Move to an electronic form of communications and document transmission • Develop an electronic trade notification of changes in policy, operations, and FDA concerns

10. FDA Import Operations-A New Paradigm For The Future • Establish a headquarters Trade Relations Officer • A automatic subscription notification of Import Alerts • Move to a electronic notification system • Website port contact listing • Establish published guidelines for filer review • Develop a electronic status query system from beginning to end of the import process • Publish enforced compliance guideline for regulatory action • Additional outreach and informed compliance with the trade.

11. FDA Import Operations-A New Paradigm For The Future • PCC responds to the March 12, 2010 Federal Register FDA Transparency Task Force request for comments on increased agency transparency (handout) • More structured approach for uniformity • Account management approach for filer evaluations • Headquarter developed FDA outreach training guidelines • Agency needs to consider returning to the grass root collaborative approach to address import operation procedures

12. FDA Import Operations-A New Paradigm For The Future • Better guidance by clearly published policy and operational procedures • Better electronic communication • Provide useful and timely answers to trade questions • Develop internal oversight systems more uniform application policies and procedures • Make more use of electronic measures to better increase the review, sampling, and testing process to better facilitate trade

13. Opportunities and Challenges Facing Our Industry • With our industry knowledge we can help FDA understand the whole supply chain process • We can help FDA improve the import process to both support better trade facilitation and increase the level public health and security • While embracing more transparency from FDA we must be willing apply the knowledge we learn

14. Opportunities and Challenges Facing Our Industry • When comments are requested we must all respond individually and through the associations committee structure • As a direct link to importer’s we have an obligation to help bring them into the process • Look to FDA and your association for better understanding and training as changes develop

15. Opportunities and Challenges Facing Our Industry • As we better understand and help develop the process we must also be willing to bring our processes into better compliance • We are the conduit for information between the regulator and regulated and must help to insure that information is complete and accurate as possible