FSVP Meeting Summaries

July 1, 2015
Bob Lake and Cathy Carnevale, the consultants to IIT who are developing FSVP training, had taken a pilot FSPCA Preventive Controls for Human Foods class and asked whether there was an expectation that they use the same format for creating a FSVP course. The PC courses are more technical, given that they are intended primarily for food manufacturers/processors, while the FSVP course is intended for importers, who could also be manufacturers, but may also be retailers and other business persons with little technical background. There was a conversation on the differences between the new supplemental FSVP proposal and the original FSVP proposal. Lake and Carnevale wanted to know more about how FDA planned to reach out to foreign food suppliers regarding the new PC and produce rule requirements – once those rules are finalized, the concern being that the foreign supplier should have awareness of these rules prior to importers contacting them about a requirements under the FSVP rule. The proposed roles of Qualified Individuals under PC and FSVP rules were also considered.

July 29, 2015
Lake and Carnevale stated that a major challenge with FSVP training is that importers may not be aware of the proposed FSVP requirements, although they will be subject to them, because some of them do not see themselves as “importers” as the term is defined under the proposed FSVP definition. The consultants also mentioned that it will be necessary to have course segments devoted to describing the Preventive Controls and Produce Safety rules, as FSVP importers are verifying that their foreign suppliers are following those rules. It will be important for importers to be able to explain to their suppliers how the FSVP program requirements fit together with the PC and produce rules. FDA expressed their hope that the tentative delivery date for the course could be late spring/early summer 2016, recognizing that none of the rules are presently final.

August 12, 2015
Lake and Carnevale have started on an outline for the course and a tentative table of contents. After the last biweekly meeting the consultants had prepared and sent to FDA and IIT a draft timeline for preparation of a 1.5 day FSVP course, FSVP modules for incorporation into the PC and produce courses, and a train-the-trainer course. The timeline was discussed in detail at this meeting. There was a question about the timelines for the PC and produce courses and how they might affect the FSVP launch date, which was projected in the draft timeline for late summer/early fall 2016. Lake and Carnevale were hopeful that the final FSVP course could also incorporate FDA guidance on FSVP, if it is available, so importers could better understand how the rule is to be implemented in practice, as it will present a major change for food importers

August 26, 2015
Participants agreed that a conference call with importers should be considered a high priority, as input from many types of importers is needed to determine the type and level of FSVP training needed. A draft outline of the course, developed by Carnevale and Lake, will be sent to IIT and FDA for review very soon, noting, of course, that it is based on their understanding of the FSVP proposed rule (original and supplemental). Carnevale and Lake are planning to meet with FDA to gain a better understanding of the interrelationships among the PC, Produce and FSVP rules, recognizing that FDA cannot share information on development of the final rules.

September 9, 2015
Carnevale and Lake thanked FDA for their comments on the course outline. They also reported that the first Importers Working Group call is scheduled for September 14. The agenda includes introductions, a description of the project, a discussion on what the importers think is most important for the FSVP course to cover, and possible roles for the Importers WG in the project. Carnevale and Lake have prepared questions for FDA for an upcoming conference call with FDA to clarify how the PC, produce and FSVP rules will fit together as they need to understand these interactions in preparing the course curriculum. A new revised course outline based on the comments had been sent to FDA and IIT.

September 23, 2015
Lake and Carnevale gave a status report on the FSVP course progress, as they continue to work on the curriculum. They are also busy digesting the Preventive Controls final rules for human and animal food that just published on September 17, 2015. They felt the Webinar Series that FDA had held September 15, 16, and 17, were very useful to them, especially when the questions touched on food imports. They also mentioned that the Importers WG call had good turnout and discussion of the FSVP course objectives. Future Importers Working Group meetings will take place every three weeks, the next taking place on October 5.

October 7, 2015
Lake and Carnevale have prepared seven chapters of draft slides for FSVP training. They will be sending some of these chapters to FDA and IIT for review to see if they are on the right track for the course presentations. It was noted that the Importers WG has some significant gaps in representation. More members will be invited to the Importer Working Group.

October 21, 2015
Bob Brackett gave a brief summary of the FDA FSMA meeting held in Chicago on October 20 in which he participated. Both Lake and Carnevale felt that the comments received from FDA on Chapters 1-3 slides were quite useful. Work is continuing on the rest of the chapters, pending publication of the final FSVP rule. Lake and Carnevale discussed feedback from the Importers WG meeting on importer concerns about how FSVP will work in practice and how FDA will enforce compliance with the rule. Lake and Carnevale reported on the additional retail member added to the Importers Working Group, a discussion with a brokers organization, and the efforts to have a representatives from the pet food industry and ethnic grocery stores added to the group.

November 4, 2015
Carnevale and Lake gave an update of the FSPCA Lead Instructor training for PCHF they attended in Vancouver, Washington. Carnevale said she had been researching Adult Learning techniques to help with the FSVP curriculum. There was a detailed discussion of how a number of things learned in refining the PC curriculum could be adapted for the FSVP curriculum. In a conversation about how the FSVP rule would be implemented, FDA indicated that very little would change in the food importation process itself, however, FDA’s regulatory oversight of the US importers responsible for complying with FSVP requirements, in particular the recordkeeping requirements, will be new. The industry will need time and training to transition into these new requirements.

November 18, 2015
Lake said that the preamble for the FSVP Final Rule, which went on display November 17, gave both him and Carnevale insights into FDA’s thinking on the benefits and practical implementation of the FSVP rule. They said that they were busy reading the hundreds of pages of the final FSVP and produce rules. They acknowledged that most of their work to date, utilizing only the proposed rules, was groundwork for developing the course, and now they could work with some certainty based on the FSVP preamble guidance and final rule to prepare the entire course. They were enthusiastic to get started with fresh knowledge. Lake and Carnevale will be setting up meetings with the FDA to discuss remaining questions and with IIT to discuss logistics.

January 13, 2016
Lake and Carnevale stated that the FSVP slides based on the final rule are in process and work is being done on the exercises. They estimate that slides for all chapters of the course should be ready for initial review by FDA and IIT on February 8. IIT will consider how the Importers Working Group will be utilized in reviewing later iterations of the course, once manual text and course exercises are added. Lake and Carnevale had requested that a different slide design be utilized to distinguish the FSVP course from the PCHF and PCAF courses. The group also discussed the need for more graphics in the course to show the interfaces between FSVP and the PC and Produce rules. It was noted that IIT’s FSPCA website now has a FSVP section that is to be populated with links for further information, as well as meeting summaries and a timeline to show progress on the FSVP course development.

January 27, 2016
Lake and Carnevale reported that the first draft slides for the curriculum are still on track for completion by February 8. Daria Kleinmeier of the FDA will be taking charge of the review as Sharon Mayl will be away for the month of February. There was some discussion on comments from foreign produce growers in regards to the new produce rules, indicating that outreach to foreign produce suppliers is much needed before FSVP implementation begins. This information will also be helpful in determining the produce-related sections of the FSVP course.