Www.ncbfaa.org



NCBFAA REGULATORY AGENCIES COMMITTEE (RAC) STATUS REPORT JUNE, 2017Presented by Roger Clarke, ChairpersonSince the Annual Conference the committee has directed most of its attention and efforts on FDA implementation of its Food Safety Verification Program(FSVP) and enforcement of LED data transmission through ACE. On May 31st management of the NCBFAA, members of the RAC, along with Mr. Jon Kent and Cindy Thomas meet with Mr. Douglas Stearn, FDA Director of Enforcement and Import Operations, Office of Regulatory Affairs and Mr. John Verbeten, Director Division of Import Operations. This meeting was a follow to the NCBFAA letter sent to Mr. Stearn and the agencies written response on the implementation of FSVP and mandatory data elements in ACE. Also discussed was the enforcement of FDA reporting requirements for LED and other light emitting elements in ACE entry filing. A very candid discussion was conducted on extending the FSVP implementation date due to a lack of understand by trade on all of the FSVP new requirements. FDA stood firm on the implementation date but gave trade some leeway on furnishing the Duns number by allowing the use of UNK when the Duns number is unknown. This provision would be a temporary measure and FDA would be contacting the FSVP importer when it is used to ascertain why the Duns number was not available. The use of UNK would also trigger a document review by FDA as the complete entry data is necessary for FDA to enforce the FSVP requirements. Mr. Stearn did state that FDA would be taking an informed compliance approach in FSVP audits and would be furnishing additional outreach with webinars, FDA Q&A web page updates, and training during the FSVP audits.The RAC recommended that the FDA FSMA Technical Assistance Network (TAN) be expanded to include policy question and update the FSMA Q&A web page faster, like within 72 hours for simple questions and to notify the sender if more time would be necessary for complex questions. Mr. Stearn did make the statement that FDA would respond rapidly when FSVP issues arise preventing the movement of cargo. Any cargo movement issues should be directed to FDA and the NCBFAA RAC who can work with the Division of Import Operations for resolution. The meeting continued with a discussion on the enforcement of LED reporting in ACE entry transmission. There was still a lack of understand by trade on just what LED items FDA is interested in and what manufactured items would be excluded. FDA did put out a CSMS message on LED requirements indicating one HTS number that the committee felt was incorrect and not inclusive enough. The RAC volunteered to furnish FDA a list of HTS numbers which we feel should be flagged and some manufactured items that need clarification. On June 16, 2017, a letter was sent back to Mr. Stearn furnishing the NCBFAA HTS number recommendations and a list of commodities that need further clarification.When needed FDA will have representation present on future RAC conference calls. Mr. John Verbeten and Ms. Gayle Gehrman, FDA ACE Team, FDA Division of Compliance Systems participated in the June conference call. The RAC looks forward to continuing our past working relationship with FDA to address both ACE technical and policy issues as new regulations are implemented. The RAC is investigating an issue where a member filed FDA Prior Notice data that was furnished by the importer and was accepted by FDA but later the registration number was found to be incorrect. FDA issued a potential penalty notice to the importer and also one to the filer specifying a violation had occurred spelling out the filer firm name and specific CBP license holder name. The correct registration number was obtained and furnish to FDA Prior Notice Center and the shipment was allowed to proceed. The entry was NOT rejected by FDA and the filer was being held as one of the responsible parties for filing incorrect FDA data. FDA has since followed up with a formal warning letter to the filer of a FDA regulatory compliance infraction which will be on the firms record. This action is public record and could affect the FDA PREDICT score for all FDA regulated shipments handled by the broker. The RAC also received a report that FSIS has taken similar action on a broker for missed delivery of cargo for inspection by a trucker. The broker had not made any of the trucking arrangements or had any control over the physical movement of the cargo. The RAC will work with Mr. Alan Klestadt and the association leadership on how to address PGA regulatory action against a member for correctly transmitting data given to them, where no anomaly is present. This type of enforcement action a broker is held responsible for actions which they have no control over.The RAC will continue to monitor the follow PGA’s which have programs scheduled to be implemented into ACE in the near future:Fish & Wildlife Service- FWS HTS flags changed to be more specific but new ACE programing guidelines are still a work in process.DEA- Mandatory ACE filing scheduled to become effect on August 1, 2017.NOAA-National Marine Fisheries- Seafood Import Monitoring Program software development is in the process of being completed. Vast amounts of ACE data will be required as no DIS or hardcopy documentation permitted. Program scheduled to become effective on January 1, 2018Dept. of State-Office of Marine Conversation- Seafood monitoring program in in the pilot stage with partial documentation permitted through DIS. This may change with the NMFS monitoring program requiring full data input.EPA- Agency reports they are being inundated with questions from filers and importers that were unaware of the EPA requirements. As with many other PGA’s filers have no ability to file correction through the system. The RAC will continue to address these agencies programs through it sub-committee structure. The sub-committee chairs report to the full committee when specific problem issues arise or in areas where it is felt the NCBFAA can add suggestions to make the system be more efficient or better help the agency meet their goals. The committee needs feedback from the membership on any PGA issues as they arise so they can be timely addressed. We ask area Directors and APN members to convey this request to their respective area membership and local associations convey this request to their members. ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download