Phone conference with SBA Office of Advocacy hosted by INNOVATE Hawaii and the Hawaii Foreign-Trade Zone #9.


This proposed rule requires importers to conduct risk-based foreign supplier verification activities to verify that imported food is not, among other things, adulterated and that it was produced in compliance with FDA's preventive controls or produce safety requirements, where applicable.
To facilitate discussion on these proposed rules, INNOVATE Hawaii and the Hawaii Foreign-Trade Zone, in cooperation with the U.S. Small Business Administration Office of Advocacy, will hold a special phone conference to obtain food manufacturers/industry thoughts and comments on the proposed rules. Interested parties are invited to attend the phone conference either at FTZ9, Manoa Innovation Center, or call-in directly to the phone number below:

Thursday, December 5, 2013
Time: 9:00 am - 11:00 am
to choose from:
Foreign-Trade Zone No. 9
521 Ala Moana Blvd. Conference Room 202, Honolulu, HI 96813
Manoa Innovation Center
2800 Woodlawn Drive, Orange Room #160, Honolulu, HI  96822
Call In: 888-858-2144  Code: 5707588#



  The FDA published its proposed rule on Foreign Supplier Verification Programs (FSVP) on July 13, 2013 for importers of food for humans and animals (78 Fed. Reg. 45729, July 29, 2013). The FSVP rule is required under the Food Safety and Modernization Act (FSMA). FSMA aims to ensure that the U.S. food supply is safe by shifting the focus from responding to food contamination to preventing it. Under the proposed rule, importers would need to, among other things:

Maintain a list of their foreign suppliers;

  • Create and follow written procedures for supplier verification activities;
  • Review results of verification activities and, if hazards are not adequately controlled, take appropriate corrective action.
  • The FDA also published its proposed rule on Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and Issue Certifications as established by the FSMA (78 Fed. Reg. 45781, July 29, 2013).
  • This proposed rule establishes a program for accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities and their foods.
  • This voluntary program is for foreign facilities and foods only.



1. Introduction
By SBA Office of Advocacy, INNOVATE Hawaii and FTZ#9

2. FDA’s Notice on Re-inspection Fees
Discussion and Request for Suggestions:

  • On status and implementation of the FDA’s Notice and the status of the Agency’s Economic Hardship Guidelines.
  • Industry discussion regarding calculation of re-inspection fees.
  • Industry suggestions on development of Guidelines including how small businesses should be defined, and how to reduce regulatory burdens on covered small entities.
  • Industry thoughts on re-inspection fees as they relate to domestic and foreign facilities and agent/brokers.
  • Status of re-inspection fees as they pertain to review of laboratory submissions in response to entities on “Detention without Physical Examination.”
  • Industry suggestions on how best to resolve re-inspection fee issues.

3. Foreign Supplier Verification Proposed Rule
Discussion and Request for Suggestions:

  • Industry concerns with the reliability of FDA inspections of foreign facilities and consistency by third-party auditors/ inspectors.
  • Industry thoughts on FDA’s definition of very small importer and supplier and its assumptions on costs related to compliance and record-keeping.
  • Industry suggestions on how to achieve consistency in the product clearance process at U.S. ports and border concerns in general.
  • Industry suggestions on how to achieve consistency in the review of private laboratory packages and requirements at different FDA districts.
  • Who is ultimately responsible for compliance in state or municipality owned terminal markets, the state or municipality or the individual wholesaler?
  • Concerns about the relationship between foreign facilities and U.S. agents/brokers raising questions about responsibilities and liabilities under the proposed rule.



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