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Comments on a Previously Adopted NACMCF Final Report
Dr. David Goldman, Acting NACMCF Chairperson and Assistant Administrator, Office of Public Health Science, U.S. Department of Agriculture/Food Safety and Inspection Service (FSIS) opened the meeting at 9:00 a.m. on Friday March 20, 2009. Dr. Goldman and Ms. Janice Oliver, Deputy Director for Operations, Food and Drug Administration (FDA)/Center for Food Safety and Applied Nutrition, delivered opening remarks.
Dr. Donald Zink, Chair of the past Subcommittee that developed the adopted NACMCF report: "The Assessment of the Food Safety Importance of Mycobacterium avium subspecies paratuberculosis (MAP)" reported that the Subcommittee would like to update their report with current references since it would be valuable to have the report reflect the most recent and relevant references. Dr. Zink said that 19 new references were before the Committee and they will be reviewed and if found appropriate will be included in the document. Dr. Zink indicated that in his preliminary examination of the references, there was nothing warranting changing the conclusions of the document. There were no objections to adding these references by the Committee members. One member suggested that there should be an amendment to the report indicating the references were added after the full Committee adopted the report. Dr. Zink indicated that adding the new references would be completed within a couple of weeks and that this work would be given a high priority.
Presentation of Reports
Dr. Donald Zink, Chair of the Subcommittee on Parameters for Inoculated Pack/Challenge Study Protocols, presented this Subcommittee's draft final report to the full Committee for consideration of adoption. Dr. Zink led the group through the document, asking if members had questions. The Committee deliberated with members asking questions and providing input to the report. A point brought out by a number of members was that microbiologists and statisticians should work together in the design of these studies and that an expert microbiologist should interpret study results. A motion was made and seconded to adopt the document as final, with the understanding that the agreed upon changes would be incorporated, and that the tables would be finalized in a format suitable for publication (first motion by Alejandro Mazzotta, second motion by Lee-Ann Jaykus). Dr. Zink thanked the Committee and especially the Subcommittee members who worked very diligently in developing this report.
Dr. Uday Dessai, Chair of the Subcommittee on the Determination of the Most Appropriate Technologies for the Food Safety and Inspection Service to Adopt in Performing Routine and Baseline Microbiological Analyses, presented this Subcommittee's draft final report to the full Committee for consideration of adoption. Dr. Dessai provided an overview of the charge and the Subcommittee's approach to addressing the charge and developing the report. Dr. Dessai explained how the responses to the questions appear over multiple sections of the report and that the questions were not necessarily answered in a systematic order and that this was done to maintain the flow of the report.
Dr. Dessai led the group through the document, asking if members had questions. The Committee deliberated with members asking questions and providing input to the report. A main topic discussed was the Subcommittee's response on FSIS conducting in-house research and how it could be interpreted as being a policy issue (page 73, item number 4). The Subcommittee felt that there was a scientific component to their work and they redesigned their wording so that there would not be a direct policy implication. It was agreed that the wording of the report should be as follows: "The Committee is concerned that FSIS has no clearly defined mandate and limited infrastructure for method development and validation activities to support its public health regulatory program. This Committee is concerned with the current interpretation that method development constitutes a research activity and therefore falls outside the FSIS mandate. Consequently, this Committee recommends that FSIS assess the needs to conduct method development and validation and seek resources for this effort
Deliberations continued and a motion was made and seconded to adopt the document as final, with the understanding that all agreed upon changes would be incorporated (first motion by Irene Wesley, second motion by Michael Jahncke). Dr. Dessai thanked the Subcommittee and acknowledged the approximately 20 experts and FSIS scientists that presented their new technologies to the Subcommittee in support of this NACMCF work. Dr. Dessai gave a special mention of thanks to Peter Feng of FDA for his contributions and guidance to this work.
Introduction of a New Work Charge
COL Timothy Stevenson introduced a future Department of Defense (DoD) charge to the Committee: "Study of Microbiological Criteria as Indicators of Process Control or Insanitary Conditions." COL Stevenson provided background, details of this work charge, and the charge questions. He indicated that DoD is asking NACMCF to help with their food safety initiatives to protect and preserve the food supply of the men and women that are serving our country in uniform. He explained how his group, the Army Veterinary Service, is responsible for the food safety for our troops of all branches of the military outside of the U.S. DoD has a need to assure food suppliers and processors are offering safe foods to the troops and NACMCF input on acceptable standards for raw materials, finished products, and shelf life is needed. DoD has a food safety system audit program and they have drawn from many sources in the food safety community to develop and or adopt the standards used.
A main part of this charge is that DoD is asking for a strong scientific approach to developing standards for different commodities. This will include asking NACMCF to consider pathogens and various indicator organisms to indicate insanitary conditions or poor process control for different commodities. A number of Committee members made comments and asked questions. COL Stevenson indicated that statistical issues will be included in the charge such as sampling plans to go along with criteria that are developed and coverage of the importance of statistical analysis.
One member pointed out that an issue with using microorganisms as process control indicators is their heterogeneous distribution in foods and asked if there was any thought to using biomarkers. COL Stevenson affirmed that those types of ideas are welcome and pointed out that NACMCF is already bringing value. COL Stevenson indicated that as technology develops and as food processing systems develop, alternative indicators such as phage and biomarkers may be included for consideration.
A number of members agreed that the charge has broader implications and can serve other food safety agencies and that large private food companies would have an interest as they deal with these types of issues around the world. It was also brought out that this charge presents a different twist for the Committee as charges generally cover science supporting regulatory actions while this charge will be dealing with science for assessing food for purchase.
No comments were received from members of the public.
Dr. David Goldman adjourned the meeting at 11:00 am on Friday March 20, 2009.
A list of NACMCF members and outside participants in attendance follows. Further meeting details are available in the March 20, 2009 meeting transcript at: http://www.fsis.usda.gov/ About_FSIS/NACMCF_Meetings/index.asp.
3-20-09 NACMCF Meeting Participants
- Acting Chairperson: Dr. David Goldman
- FDA Representative: Ms. Janice Oliver
- NACMCF Members:
- Dr. Gary Ades
- Dr. Scott Brooks
- Dr. V. Kelly Bunning
- Dr. Peggy Cook
- Dr. Uday Dessai
- Dr. Daniel Engeljohn
- Dr. Timothy Freier
- Mr. Spencer Garrett
- Dr. Kathleen Glass
- Dr. Linda Harris
- Dr. Walt Hill
- Dr. Michael Jahncke
- Dr. Lee-Ann Jaykus
- Dr. Julie Ann Kase
- Dr. Stephen Knabel
- Ms. Barbara Kowalcyk
- Dr. Joseph Madden
- Dr. Alejandro Mazzotta
- Dr. Jianghong Meng
- Dr. Donald Schaffner
- Ms. Virginia (Jenny) Scott
- Dr. John Sofos
- Dr. Robert Tauxe
- Dr. Irene Wesley
- Dr. Donald Zink
- NACMCF Executive Committee:
- Dr. LeeAnne Jackson, FDA Liaison
- COL Tim Stevenson, DOD Liaison
- FSIS Staff Members
- Ms. Gerri Ransom, Executive Secretary
- Mrs. Karen Thomas-Sharp, Advisory Committee Specialist
- Dr. Evelyne Mbandi, Technical Assistant to NACMCF