FDA Registration Requirements

 

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires that domestic and foreign facilities register with FDA if they manufacture, process, pack, or hold food for human or animal consumption in the U.S. The Act also includes record keeping provisions in order to provide FDA with information on the origin and distribution of food and feed products and thereby aid in the detection and quick response to actual or potential threats to the U.S. food supply.  In November of 2005, FDA provided additional guidance on record keeping requirements, which are available at http://www.cfsan.fda.gov/%7Edms/fsbtact.html and the NIAS web site.  At the request of the NIAS Board, Dr. Nipp inquired with FDA about the extensiveness of these requirements for universities and research facilities.  Dr. Nipp was told by FDA officials that the universities do have to keep records if they sell food and feed products to the public; however, whatever records they currently keep would be sufficient.  No new or additional record keeping is required; rather, the university or research facility must be able to provide such records that they have in the event of an inquiry.  It was assumed that a research facility would be already keeping some sort of records about their food and feed products.  Universities and research facilities may wish to upgrade or modify their record keeping processes, but this is at their discretion for their own purposes and is not required by the law if some form or records are currently being kept.     

 

Animal HF-AID

 

At the U.S. Animal Health Association annual meetings in the fall, a session on new and emerging technologies for Animal Identification included a talk from a private sector company about High Frequency RFID.  This technology was originally developed for the military for covert operations and has been adapted for medical research.  Unlike passive RFID technologies and lower frequency RFID systems, High Frequency-Animal Identification (HF-AID) provides real time detection of moving animals through metal barriers at a considerable distance.  Recognizing the implications of this emerging technology for biosecurity “trace back” and animal movement forecasting, Dr. Nipp and Dr. Coston met with the company leadership about the state of this new technology.  Dr. Nipp has subsequently met with the USDA FSIS Undersecretary and Deputy Under-Secretary about the implications of the technology, which then led to meetings with APHIS, FSIS, USDA Homeland Security, the USDA Deputy Secretary, and the White House Council on Homeland Security.  Dr. Nipp has concurrently had meetings with the National Cattlemen and Beef Association (NCBA).  As an outgrowth of these meetings, NIAS was asked to host a workshop on the status of this technology, to review scientific and technical issues regarding its adoption as well as practical implications for the private sector.  An “invitational” workshop was convened in conjunction with the annual NCBA annual meetings in Colorado in February 2006.  Approximately 45 people attended, including ranchers, processors, distributors, university scientists and administrators, and federal agency representatives.  The participants recommended the development of further evaluation and testing of the technologies in large scale pilot tests, with additional workshops focusing specifically on the implications of HF-AID for electronic animal health certificates, USDA’s, National Animal Identification System, and interstate transport.  NIAS has been asked to consider hosting these workshops and will be exploring this possibility with the federal agencies and the private sector.

 

EDEN, NCFPD and Extension

 

Dr. Coston provided a briefing about NIAS at the annual meeting of the Extension Disaster Education Network (EDEN) and spoke with their leadership about closer collaboration between EDEN and NIAS.  Concurrently, the DHS National Center for Food Protection and Defense is interested in working with Extension to develop and distribute educational materials that it will be developing for DHS.  NIAS will be facilitating a series of discussions between the leadership of EDEN, NCFPD, and Extension to consider how to best collaborate in the future.

 

DHS Food and Agriculture Sector Coordinating Council

 

Dr. Nipp participated in the DHS Food and Agriculture Sector Coordinating Council (FASCC) meeting in January 2006.  As a member of the FASCC, Dr. Nipp has been receiving “sensitive” briefing materials and alerts that have been issued, from time to time, by DHS.  At the recent Council meeting, Dr. Nipp asked if a protocol could be developed that would allow him to share some of these sensitive materials, as appropriate, with the NIAS leadership and membership. Similarly, DHS has developed a web site (HSIN) that is intended to share sensitive information with industry leadership in a secured environment.  DHS and other federal agency personnel indicated that they understood that this was a critical issue and there was interest in working out a process whereby information was shared more broadly, but that in fact this remained a challenging issue and they had not fully worked out a process for sharing information with industry groups, beyond the identified points of contact represented in the FASCC.  The issue of “sensitivity” is being examined again by the National Academy of Sciences.  Having reviewed the status of this issue with the NIAS Board, Dr. Nipp will continue to look for ways to strengthen communications protocols with the agencies.      

 

FBI Conference

 

Last summer, the FBI hosted an international conference on agrosecurity.  A similar conference is being proposed for this September.  Dr. Nipp has been in conversations with university and agency specialists about the possibility of “science and education” component in the next conference, or, the possibility of a concurrent workshop on agrosecurity science and education issues pertinent to FBI’s counterterrorism interests.  NIAS will seek to be part of the planned activities, or to facilitate complementary concurrent activities, as is determined to be of most interest to the involved federal agencies.

 

National Science Advisory Board for Biosecurity

 

The next National Science Advisory Board for Biosecurity (NSABB) meeting will be held on March 30^th.  The discussions will focus on criteria for identifying dual use research, a code of conduct for life scientists, principles and tools for the responsible communication of dual use research results, international perspectives on the dual use dilemma, and biosecurity issues relevant to synthetic genomics.  Dr. Nipp will be providing information about NIAS activities at t he NSABB meeting. 

 

Hazardous Non-Select Agents

 

Last year, USDA and CDC made some adjustments to their recommendations for handling select agents.  NIAS has incorporated these changes in a model “decision-aid” for voluntary management of hazardous non-select agents (HNSA).  Over two dozen representatives HNSA have been categorized for management purposes by the decision-aid, and an initial sort on a large array of materials has been developed.  This initial classification will be returned to several collaborating universities to evaluate the practical implications of this aid and the initial classification, and the aid and classifications will be adjusted as appropriate.  A report on the decision aid and the voluntary management guidelines will be available for review at the next annual meeting of the Experiment Station Directors in 2006.