Confirmation Number:261475 Event Started: 9/22/2004 2:23:30 PM Event Ended: 1/1/0001 12:00:00 AM

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PLEASE STAND BY, THE CONFERENCE WILL BEGIN MOMENTARILY. &%F0

PLEASE STAND BY, THE CONFERENCE WILL BEGIN SHORTLY.

WE DON'T WE BEGIN. I WANT TO THANK EVERYBODY FOR THEIR ATTENTION AND THEIR INPUT INTO THIS PROCESS. AND I WAS GOING TO SPEND A MINUTE SORT OF GENERALLY WRAPPING UP THE DISCUSSIONS WITH SOME OVERARCKING POINTS AND THEN FOR THOSE WHO DON'T KNOW THERE ARE HANDOUTS ON THE TABLE OUTSIDE WHICH INCLUDE THE POINTS TO CONSIDER ALONG WITH SOME EXAMPLE TEMPERATURE PLATES THAT WE WILL BE -- TEM DC PLATES WE WILL BE DISCUSSING THAT CAME OUT OF PREVIOUS DISCUSSIONS AND DISCUSSIONS FROM LAST NIGHT AND THE MEMBERS AT THE TABLE HAVE THOSE IN FRONT OF THEM. SO, I WANT TO SAY TO BEGIN WITH THAT THE MEETING AND THE DEVELOPMENT OF THE POINTS TO CONSIDER IS ONLY A BEGINNING OF AN ONGOING PROCESS NECESSARY TO KEEP IBCs UP TO DATE WITH THE SCIENTIFIC AND MEDICAL ADVANCES THAT THEY USE TO INFORM THEIR CONTAINMENT DECISIONS. AND THAT THE POINTS TO CONSIDER ARE MEANT TO BE A RESOURCE FOR IBCs, NOT ONLY FOR THE INFECTIOUS AGENTS DISCUSSED AT THIS MEETING BUT ALSO TO PROVIDE A FRAMEWORK FOR IBCs DELIBERATIONS OF CONTAINMENTISH SHIES ATTENDANT TO RESEARCH ON EMERGING INFECTIOUS DISEASES AND AGENTS. AND THE RESEARCH INTO VIRAL VIRULENCE MECHANISMS AND THE DEVELOPMENT OF VACCINES AND ANTIVIRAL DRUGS ARE PUBLIC HEALTH PRIORITIES AND WHILE THIS RESEARCH IS OF CRITICAL IMPORTANCE IT IS EQUALLY IMPORTANT THAT THE RESEARCH BE FORMED RESPONSIBLY TO PROTECT THE HEALTH OF LABORATORY WORKERS, MEDICAL WORKERS AND THE PUBLIC. SO WHAT ARE SOME OF THE OVERARMING PRINCIPLES THAT WERE DISCUSSED AND HAVE COME OUT OF THIS MEETING? ONE OF WHICH IS A PROCESS EEDS TO BE ESTABLISHED WHEREBY IBCs CAN SHARE INFORMATION AND THEIR EXPERIENCES IN DETERMINING APPROPRIATE CONTAINMENT LEVELS. AND THAT IS A VERY IMPORTANT PART OF IBC TO IBC COMMUNICATION AND SHARING OF INFORMATION. A SECOND PART IS THAT EDUCATION, FORMAL TRAINING, MEANTORING OF PERSONNEL WHO WORK WITH INFECTIOUS AGENTS IS PARAMOUNT TO ASSURE APPROPRIATE BIOSAFETY PRACTICES ARE FOLLOWED. A THIRD POINT IS THAT APPROPRIATE INSTITUTIONAL SUPPORT AND OVERSIGHT IS NECESSARY FOR IC IBCs TO FUNCTION OPTIMALLY AND THIS IS SOMETHING THAT WE HAVE HEARD OVER AND OVER AGAIN IS THAT IBCs REQUIRE MORE SUPPORT FROM THE INSTITUTIONS IN ORDER TO BE ABLE TO DO THEIR WORK CORRECTLY. WHAT ARE FUTURE EFFORTS TO HELP IBCs AND INVESTIGATORS? OBA HAS AND WILL CONTINUE TO PROVIDE EDUCATIONAL PROGRAMS AND ASSISTANCE TO IBCs AND AS WAS TALKED ABOUT YESTERDAY, IN THIS MEETING AND CERTAINLY LAST NIGHT AS WELL, THE FIFTH REVISION OF THE BIOSAFETY AND MICROBIOLOGICAL AND MEDICAL LBTS THE BMBL IS IN PROGRESS AND WILL PROVIDE SPECIFIC GUIDANCE FOR INFLUENZA AND AS A COLLABORATIVE PROCESS BETWEEN HHS AND THE USDA. THEREFORE, SOME OF THE ISSUES WITH RESPECT TO NOT KNOWING WHO TO GO TO WHEN YOU ARE TRYING TO WORK WITH A PARTICULAR ORGANISM, ESPECIALLY THE H5N1 OR ANY OF THE ORGANISMS THAT HAVE AGRICULTURAL EFFECTS WILL BE TALKED ABOUT AND HOPEFULLY CLARIFIED IN THE UPCOMING RELEASE OF THE BMBL. REMEMBERING THAT, THE WORK WITH THOSE STRAINS IS A PERMIT PROCESS THAT REQUIRES USDA PERMIT. SO WITH THAT, I'M GOING TO STOP ON THE OVERARCHING POINTS AND IN FRONT OF YOU ALL ARE THE POINTS TO -- SAFETY CONSIDERATIONS AND POINTS TO CONSIDER WHICH INCLUDES THE GENERAL POINTS I JUST WENT OVER AND I WILL -- THE OTHER POINTS THAT CAME OUT DURING THE SESSIONS AND INCLUDING LAST NIGHT'S AND WE WILL START A DISCUSSION OF THOSE. AND I WILL TURN IT BACK OVER TO NEAL AND KAY.

GOOD MORNING. I GUESS WE SHOULD JUMP RIGHT INTO THIS. IT IS FAIRLY LONG DOCUMENT. WITH RESPECT TO THE GENERAL POINTS THAT STEVE HAS JUST DISCUSSED, MAYBE WE SHOULD JUST GO OVER THOSE FIRST. AND ELICIT ANY COMMENTS REGARDING CHANGES IN THOSE POINTS. NOW, ON THE DRAFT TAY HAVE, I -- THAT I HAVE, I DON'T HAVE THE BMBL. IS THAT --

NO, THAT WAS NOT INCLUDED IN THAT.

OKAY. SO THE POINT NO. FIVE REGARDING THE MODIFICATION OR UPDATING OF THE BMBL IS NOT ON THIS DOCUMENT BUT WILL BE ON THE FINAL DOCUMENT. I GUESS LET'S START WITH THESE GENERAL POINTS AND I JUST WOULD LIKE TO THROW IT OUT DOES ANY ONE HAVE ANY COMMENT ON THESE GENERAL POINTS?

WHOSE RESPONSIBILITY WILL BE IT TO DEVELOP THE PROCESS FOR SHARING IBC INFORMATION? SHOULD THIS BE OBA'S RESPONSIBILITY TO ESTABLISH SOME KIND OF INTERACTION OR ARE YOU JUST ENCOURAGING THE IBCs TO CALL EACH OTHER UP?

I'D LIKE TO HEAR CERTAINLY OBA IS WILLING TO PROVIDE SUPPORT TO IBCs BUT WE CANNOT BE A TOTAL CLEARINGHOUSE FOR EVERYTHING THAT GOES ON SO THE QUESTION IS WHAT ARE THE IBC SOCIETIES IN THE SAME WAY THEIR SOCIETIES FOR PROFESSIONALS IN SCIENCES AND HOW CAN THEY TAKE PART IN THIS PROCESS.

ONE OF THE WAYS THAT THIS MIGHT BE DONE IN A SORT OF A PASSIVE MANNER IS TO AT FREDERICK WHAT WE DO EVERY MONTH IS AT THE CONCLUSION OF OUR IBC MEETING WE SUMMARIZE THE DISCUSSIONS AND POST THEM ON A WEBSITE AND ANYBODY CAN ACCESS THAT WEBSITE AND READ THE PROTOCOLS OR AT LEAST A SUMMARY OF THE PROTOCOLS THAT WERE DISCUSSED AT THE MEETING. THAT WOULD AT LEAST GIVE ANOTHER IBC THE OPPORTUNITY TO CONTACT AN INVESTIGATOR WHO IS PERHAPS DOING RESEARCH WITH A SIMILAR ORGANISM OR THE SAME ORGANISM. IT WOULDN'T GIVE YOU DETAILED INFORMATION BUT WOULD AT LEAST GIVE YOU AN IDEA OF WHO TO CALL.

I THINK ALL OF -- FOR MANY MEMBERS OF EACH IBC ARE PROBABLY ASSOCIATES OR MEMBERS OF THE AMERICAN BIOLOGICAL SAFETY ASSOCIATION AND I THINK I HAVE HEARD ON A NUMBER OF OCCASIONS THE WILLING NECESSARY OF THAT ORGANIZATION TO SERVE AS A CLEARINGHOUSE. THEY CERTAINLY HAVE A MISSION FOR TRAINING AND I THINK WE HAVE HEARD FROM MEMBERS AND I THINK JAN IS A COUNCIL MEMBER AND IS KEEPING THE LEADERSHIP OF ABSA AWARE OF THESE ISSUES BUT IT MIGHT BE A SITE THAT MIGHT BE A NEUTRAL CLEARING GROUND AS WELL IN ADDITION TO THE WEBSITES THAT INDIVIDUAL INSTITUTIONS SET UP.

I THINK ALSO AS PEOPLE PREPARE REPORTS FOR JOURNALS OF THEIR SCIENTIFIC RESEARCH IF THEY ARE WORKING WITH NEWER AND NOVEL ORGANISMS IF THEY COULD BE ENCOURAGED TO PROVIDE IN THE BODY OF THE REPORT AS WELL AS IN THE ABSTRACT SOME INFORMATION REGARDING THE CONTAINMENT LEVEL THAT WAS CHOSEN AND WHAT THINKING WENT INTO HAVING THAT CONTAINMENT LEVEL IT WOULD BE VERY HELPFUL TO IBCs AS WELL AS OTHER RESEARCHERS. AND I DON'T KNOW IF THERE IS ANY WAY THAT WE COULD ENCOURAGE THAT KIND OF INFORMATION TO BE ADDED TO PAPERS.

I THINK IF YOU DECREASE THE PAGE CHARGES. IT IS POSSIBLE ONE WAY THAT WE COULD CONTACT THE JOURNAL EDITORS OR -- AND ASK THEM TO BE AWARE OF THAT SITUATION TO ENCOURAGE CONTRIBUTORS TO ADD THAT KIND OF INFORMATION.

I DON'T KNOW WHETHER AMERICAN SOCIETY FOR MICROBIOLOGY MIGHT TAKE A POSITION ON THIS AND THAT WOULD AT LEAST AFFECT ASM JOURNALS. IT MIGHT BE ABLE, FOR EXAMPLE, TO BE PROVIDED AS SUPPLEMENTAL ONLINE INFORMATION WHICH WOULD BE READILY AVAILABLE TO PEOPLE SO THAT MIGHT BE ONE VENUE.

ANY ADDITIONAL COMMENTS ON THESE GENERAL POINTS?

ON THE GENERAL POINTS, OFTEN PEOPLE KIND OF READ FROM TOP DOWN AND I WOULD JUST SUGGEST MOVING THE FIRST POINT TO NUMBER 3 AND HAVING THE WHOLE ISSUE OF EDUCATION AND TRAINING BE RIGHT AT THE TOP AND THEN FOLLOWED IMMEDIATELY BY PROVIDING APPROPRIATE INSTITUTIONAL SUPPORT BECAUSE I THINK THAT THAT HAS BEEN REITERATED A NUMBER OF TIMES AT THIS TABLE BY THE RESEARCHERS HERE THAT THEIR MOST IMPORTANT SAFETY CONSIDERATION IS APPROPRIATE TRAINING AND MONITORING OF THE PEOPLE WHO WORK IN THESE LABS ON THESE ORGANISMS AND THAT SHOULD REALLY COME OUT FIRST.

YOU RAISED AN INTERESTING POINT THERE. ARE YOU SUGGESTING THAT THE INSTITUTIONAL SUPPORT SHOULD INCLUDE TRAINING AND EDUCATION? OR IS THAT THE RESPONSIBILITY OF THE PRINCIPAL INVESTIGATOR?

WELL, I DON'T KNOW HOW THE PRINCIPAL INVESTIGATOR WOULD DO IT UNLESS THEY HAD SOME SUPPORT TO DO IT ALSO. I MEAN I THINK IT IS A CHICKEN OR EGG THING. BUT IF PEOPLE ARE JUST SORT OF DOING TRAINING AS AN ADD ON IT IS GOING TO GET SHORT SHIFT AND AGAIN SOME OF THE COMMENTS THAT WE HAD IN OUR DISCUSSIONS AT DINNER WAS, YOU KNOW, ARE THE IBCs WHEN THEY SEE THESE PROTOCOLS SUPPLIED WITH A REAL EXPLICIT TRAINING PLAN OR DOES THE COMMENT JUST SAY IN RESPONSE TO, YOU KNOW, WHAT IS THE TRAINING OF THE PERSONNEL WE WILL PROVIDE THE TRAINING PROGRAM AND A MONITORING PROGRAM. AND THERE CAN BE A BIG DIFFERENCE IN THE QUALITY OF WHAT IS PRO PROPOSED. AND ANY TIME YOU IMPOSE SOMETHING LIKE THAT I THINK THAT RESOURCES ARE NEEDED FOR IT. WHETHER IT COMES DIRECTLY FROM THE SPONSORING INSTITUTION OR FROM THE GRANT IT NEEDS TO HAVE RESOURCES ASSOCIATED WITH IT.

UNFUNDED MANDATES HAVE A LONG HISTORY IN THE GOVERNMENT. AND MY CONCERN IS THAT PEOPLE WILL BE TOLD TO DO THIS BUT NOT PROVIDED WITH ASSISTANCE AND I WOULD LIKE TO SEE SOMETHING COME FORWARD AS RECOMMENDATIONS FOR EXACTLY WHAT THE TRAINING WOULD INVOLVE AND I THINK THAT COULD BE A CENTRAL UNCTION. WHAT IS THE OVERSIGHT INVOLVED HERE IN THE POINT NO. THREE? WHO IS THE INSTITUTIONAL OVERSIGHT THERE?

THAT REFERS TO THE INSTITUTIONAL OFFICIAL WHO IS RESPONSIBLE FOR IBC FUNCTION AND MANAGEMENT AND IT CAN BE DIFFERENT PEOPLE AT DIFFERENT INSTITUTIONS WHETHER IT BE THE DEAN OF RESEARCH, THE PROVOST OR THE QUOTE, UNQUOTE RESPONSIBLE ADMINISTRATION OFFICIAL BUT THERE IS SOMEBODY WHO THE IBC REPORTS TO.

SO ARE WE -- ARE WE JUST MAKING PEOPLE AWARE OF THE NIH GUIDELINES? IS THAT WHAT THIS IS BECAUSE THIS IS IN THE NIH GUIDE LINES.

THE ANSWER IS WE ARE REITERATING WHAT IS IN THE -- AND EMPHASIZING WHAT IS IN THE NIH GUIDELINES WITH RESPECT TO IBC AND INSTITUTIONAL RESPONSIBILITY.

CAN WE USE A BETTER WORD THAN APPROPRIATE? MAYBE WE NEED TO GIVE MORE EMPHASIS LIKE STRONG INSTITUTIONAL SUPPORT.

APPROPRIATE IS -- ENABLES ANYTHING TO HAPPEN. &%F0. SUGGESTING WE USE THE WORD STRONG OR FOR APPROPRIATE OR SOME OTHER WORD TO EMPHASIZE THE IMPORTANCE OF A TRUE LEADERSHIP AND VERSIGHT.

I'M INTERESTED IN WHAT -- WHAT KATE RAISE THE ABOUT UNFUNDED MANDATES BECAUSE I DO THINK, YEAH, YOU DO NEED FUNDING FOR SOME OF THESE THINGS AND WHETHER YOU SAY TO AN INSTITUTION, YOU KNOW F YOU'RE GOING TO GO FOR THESE GRANTS THEN YOU ALSO NEED TO FUND WHAT IS NEEDED TO SUPPORT THEM PROPERLY OR THAT THE GRANTS NEED TO INCLUDE AN ELEMENT THAT PROVIDES RESEARCH -- THAT PROVIDES SUPPORT FOR THE OVER"SIGHT" OVERSIGHT AND THE TRAINING BUT, YES, PEOPLE NEED TO KNOW THAT IT IS NOT JUST SOMETHING THAT CAN BE TAGGED ON AND IT IS OH, BY THE WAY, DO THIS ALSO. BUT THAT IT NEEDS TO BE WELL CONSIDERED ELEMENT OF THE RESEARCH.

LET ME JUST COMMENT ON THAT. INSTITUTIONAL OFFICIAL IS REQUIRED TO -- THEY HAVE TO DO THAT. THE INSTITUTIONAL SUPPORT OFTEN THAT -- WELL, ALL THE TIME, THAT IS WHAT THE INSTITUTIONAL OFFICIAL IF HE IS THE -- IF HE OR SHE IS THE DEAN OR IF THERE IS MONEY AVAILABLE THAT WILL DEPEND ON HOW MUCH SUPPORT IBCs GET AND THAT IS GOING BE DRIVEN BY WELL, HOW -- WHAT IS THE CULTURE THAT -- AT THAT UNIVERSITY? HOW MUCH RESEARCH ARE THEY DOING? HOW CONCERNED ARE THEY ABOUT BEING COMPLIANT? AND I DON'T KNOW IF WE CAN MANDATE THAT AT ALL. I MEAN WE CAN'T DO ANYTHING ABOUT THAT. AND FOR ALL I KNOW, A LOT OF INSTITUTIONS MIGHT -- THEY HAVE AGREED TO OR THEIR INDIRECT COST IS SUPPOSED TO TAKE CARE OF THIS SORT OF THING SO IN TERMS OF GETTING MORE MONEY FROM THE GOVERNMENT TO DO THIS, I'M NOT SURE THAT YOU WILL BE ABLE TO DO THAT BECAUSE THEY WILL JUST SAY, WELL THAT IS WHAT INDESKTOP COSTS -- INDIRECT COSTS ARE FOR.

I DON'T THINK WE CAN MANDATE ANYTHING GI MEAN ONE OF THE ISSUE -- I MEAN ONE OF THE ISSUES HERE OF THE RAC AND THE IBCs ARE WE ARE NOT REGULATORY. I THINK THAT IS GOOD. BUT I CERTAINLY THINK WE HAVE A BELIEVE OPEN AND WE SHOULD USE IT. THE OTHER THING, THE LAST POINT WHICH IS NOT ON THIS LIST BUT WHICH STEVE SHOWED ABOUT THE THREE AGENCIES COMING TOGETHER TO CREATE THE BMBL. I FOUND THAT ONE OF THE MOST HOPEFUL AND ENCOURAGING THINGS THAT I HEARD THAT THE MEETING. I THINK IT IS REALLY WONDERFUL AND I HAVE HEARD A LOT OF PEOPLE IN THE PAST SAYING, YOU KNOW, WE HAVE TO -- WE HAVE TO MARCH TO ALL THESE DIFFERENT DRUMMERS. WE HAVE TO -- WE HAVE TO GO TO THIS AGENCY AND THAT AGENCY AND THE WHOLE IDEA THAT THIS IS BEING BROUGHT TOGETHER AND THE PEOPLE THAT ARE WRITING THESE RECOMMENDATIONS ARE MEETING AHEAD OF TIME AND THIS WAS APPARENT ALSO IN OUR TELECONFERENCES WHEN WE WERE PREPARING FOR THIS SEMINAR. I JUST THINK THAT WHATEVER WE CAN DO TO ENCOURAGE THAT AND TO PRAISE THE PEOPLE WHO HAVE DECIDED TO DO THIS AND IN FACT ARE DOING THE WORK FOR IT THAT THAT SHOULDN'T JUST GO BY THE BOARDS AND THANK YOU VERY MUCH. BUT I THINK THAT REALLY SHOULD BE HIGHLIGHTED AND ENCOURAGED AND THE PEOPLE WHO ARE MOVING ON THIS SHOULD BE SUPPORTED BECAUSE MY GUESS IS TO SOME EXTENT IT IS ALSO AN ADD-ON FOR SOME OF THEIR JOBS AND TO PROVIDE WHATEVER KIND OF SUPPORT WE CAN EVEN IF IT IS -- IF IT IS ONLY VERBAL SUPPORT FOR THEIR CONTINUING WITH THIS WORK AND THEN MOVING IT TO THE LEVEL OF THE USERS OF THESE DOCUMENTS BECAUSE THESE -- EACH OF THESE AGENCIES HAS A SEPARATE GROUP OF USERS AND THE USERS NEED TO THEN BE BROUGHT TOGETHER. SO IT IS -- ONE COULD LOOK UPON IT AS NO GOOD DEED GOES UNPUNISHED, THANK YOU VERY MUCH, DO SOME MORE. THE OTHER WAY IS TO SAY THANK YOU FOR DOING THIS AND WE REALLY ENCOURAGE YOU TO CONTINUE IN THIS WORK. &%F0.

AS THE FEDERAL GOVERNMENT SUPPORTS MORE AND MORE BSL FACILITIES AND FUNDING FOR HIGH PASSITY AGENTS I THINK THERE WILL COME A TIME WHEN WE NEED SOME KIND OF CERTIFICATION FOR THE PEOPLE WHO ARE BEING TRAINED AND WISH TO MOVE FROM ONE PROGRAM TO ANOTHER AND I THINK IT IS TIME, IF NOT IN THIS DOCUMENT, BUT CERTAINLY AROUND THIS TABLE FOR PEOPLE TO CONSIDER HOW SUCH CENTRALIZED TRAINING AND CERTIFICATION MIGHT BE ACHIEVED.

JUST WANTED TO COMMENT ON THE VALUE OF THIS KIND OF TRAINING GUIDANCE. INSTITUTIONAL SUPPORT IN MY OBSERVATION IS LESS OF AN ISSUE IN LARGER GRANT RECIPIENTS. WE -- I SEE A WIDE VARIETY IN THE COMMUNITY THAT I LIVE IN. THERE ARE MANY SMALLER AND MANY LARGER INSTITUTIONS THAT ARE ATTEMPTING TO CONFORM TO THE GUIDELINES. AS A RULE, THE LARGER INSTITUTIONSS, THE ACADEMIC INSTITUTIONS HAVE TRAINING PERFORMED BY CENTRALIZED STAFF THAT ARE ALREADY THERE FULL TIME. THEY DO IT OVER AND OVER AGAIN AND ON A REGULAR SCHEDULE. WHAT CONCERNS ME ARE THESE ALL LER RECIPIENTS ARE GRANTS OR IN THE CASE OF COMPANIES THAT AREN'T GRANT RESAWYER INTERNATIONARECIPIENTSTHAT ARE SIMPLY TRYING TO CONFORM TO THE GUIDELINES. IN THOSE CASES I THINK THE KIND OF GUIDANCE MATERIAL WE TALKED ABOUT WOULD BE EXTREMELY USEFUL. A -- A TEM PLATE FOR TRAINING AND A CHECK LIST AND THAT SORT OF THING.

I AGREE THAT MOST INSTITUTIONS HAVE SAFETY SUPPORT PERSONNEL WHO PROVIDE TRAINING TO RESEARCHERS BUT IT IS ON -- AND SO THAT IS THE SUPPORT THE FACILITY IS PROVIDING. BUT IT IS MORE ON AN EXPLAIN TORRE ACADEMIC LEVEL AND IT IS NOT -- WE DON'T HAVE THE ABILITY TO BE IN THE LAB AND ACTUALLY TRAIN SOMEONE IN THE PROCEDURES AND OVERSEE WHAT THEY ARE GOING TO BE DOING AND I THINK PERHAPS THIS DOCUMENT COULD ENCOURAGE THE HEADS OF LABORATORIES WHO ARE RESPONSIBLE FOR THE SAFETY IN THEIR LABS TO HAVE ACTUALLY A WRITTEN TRAINING PROGRAM OF THIS APPRENTICESHIP OF WHAT THEY -- WHAT THEIR PROGRAM IS BEFORE THEY ALLOW PEOPLE WHO WORK IN THEIR LAB TO ACTUALLY GO IN AND WORK WITH THE PATHOGENIC ORGANISMS.

I THINK THAT IS AN IMPORTANT DISTINCTION BETWEEN THE TWO. THE TRAINING IN TERMS OF THE GENERAL GUIDELINES I THINK IS FAIRLY COMPLETE IN MOST INSTITUTIONS. THE PRACTICE IN THE LABORATORY IS REALLY DEPENDENT UPON THE EXPECTATIONS OF THE PRINCIPAL INVESTIGATOR AND KAY TALKED ABOUT A CERTIFICATION PROGRAM. IT WOULD SEEM TO ME THAT WITH THE DEVELOPMENT OF THE REGIONAL CONTAINMENT FACILITIES AND HIGH CONTAINMENT FACILITIES THAT THE GOVERNMENT IS INVESTING IN AND THE RECOGNITION THAT THEY ARE GOING TO BE -- THERE ARE GOING TO BE MANY MORE PEOPLE WORKING WITH PATHOGENIC AGENTS IN THE FUTURE WHO HAVE NEVER WORKED WITH THEM BEFORE, THAT IT WOULD BE APPROPRIATE FOR THESE CENTERS TO REALLY HAVE DEDICATED COURSES IN HANDLING INFECTIOUS AGENTS WHERE THE SKILLS OF DOING THE EXPERIMENTAL PROTOCOLS SO THAT THEY REDUCE THE RELEASE OF ORGANISMS BECOMES ENGRAINED EARLY ON. I CAN REMEMBER IN THE EARLY DAYS OF THE BIOENTOLING PROGRAM THE GOVERNMENT SPONSORED A MAJOR TRAINING INITIATIVE WHAT THE ASM TO BASICALLY INTRODUCE PEOPLE WHO HAD NEVER WORKED WITH THESE MATERIALS TO A CONCEPT OF STERILE TECHNIQUE AND I THINK ARE ENCOURAGING SOME EFFORT ON THE PART OF THE GOVERNMENT TO SPOARNS PROGRAMS OF -- SPONSOR PROGRAMS OF THIS TYPE, PARTICULARLY FOR A VERY DANGEROUS PATHOGENS. IT WOULD BE OF GREAT VALUE AND A STARTUP SOON I THINK WOULD BE TREMENDOUS.

I WAS GOING TO COMMENT ABOUT I HAVE SOME KNOWLEDGE ABOUT THE TRAINING THAT THEY HAVE PLANNED FOR THE BIOCONTAINMENT LABORATORY IN BOSTON. PART OF THE FACILITY IS INTENDED TO TRAIN PEOPLE TO WORK AT A HIGH CONTAINMENT LEVEL. I HAD SEEN SOME OF THE EARLY DESIGNS. IT IS VERY NICE. I'M NOT SURE HOW MUCH OF A RESOURCE IT IS GOING TO BE FOR THOSE WHO ARE WORKING AT BL3 ONLY BECAUSE OF THE SHEER VOLUME OF THE NUMBER OF LABS. OBVIOUSLY BL3 IS GOING UP OF LATE AND THE NUMBER OF PEOPLE WHO WOULD BE WORKING IN THOSE LABS HAS ALSO -- WELL, OR WILL GO UP. BUT THAT WAS SOMETHING THAT WAS TAKEN INTO ACCOUNT APPARENTLY WHEN THEY CONSTRUCTD THAT LABORATORY.

CAN YOU GO TO THE MICROPHONE, PLEASE?

I'M RESPONSIBLE FOR AN RDL AT THE UNIVERSITY OF PITTSBURGH THAT IS AT THE LEVEL OF BL3, OKAY. SO WHEN YOU ARE TALKING ABOUT BOSTON AND BL4 YOU ARE RIGHT, THERE IS -- THERE IS -- THE NAID IS SUPPORTING EVEN PERSONNEL TO RUN THAT FACILITY OR THERE IS THOUGHTS ABOUT THAT. BUT DR. BARKLEY YOU RAISE A HUGE CONCERN OF MY OWN AND THAT IS FORMAL TRAINING AT THE BL3 LEVEL BECAUSE WE ARE STILL HANDLING DEADLY AGENTS THAT WE WOULD RATHER NOT GET INTO THE ENVIRONMENT. THE BL3 ENHANCED AGENTS OR PLUS OR WHATEVER WE WANT TO CALL THEM IS CERTAINLY UNDER THAT PURVIEW AND THAT IS YOU DISCUSSED TODAY. THERE IS NO MECHANISM OR FUNDING FOR PERSONNEL. THE FUNDING FOR LABORATORIES ARE UP TO THE INSTITUTION TO PROVIDE THIS SORT OF THING AND IF YOU HAVE GOOD ENVIRONMENTAL HEALTH AND SAFETY SUPPORT WHICH I THINK WE DO AT THE UNIVERSITY OF PITTSBURGH THEN YOU CAN SEE A MECHANISM MONTREAL EXPOS NICE TO DO IT BUT I THINK THAT -- AMECHANISM TO DO IT BUT NOT EVERY UNIVERSITY HAS THE SUPPORT THAT WE DO AT THE UNIVERSITY OF PITTSBURGH. I LAD THAT THAT MAYBE THE SUGGESTIONS THAT YOU ARE MAKING THAT THERE BE SPECIFIC INITIATIVES FOR FORMAL TRAINING. I THINK THERE IS A REAL DEFICIT THERE.

ANY MORE COMMENTS ON THE GENERAL OINTS? FLUSH LEASE STAND BY. AUDIO CONNECTION HAS BEEN LOST &%F0.

CLEAR TO ME THAT SIGNIFICANT PROPORTION OF THE INFORMATION THAT WOULD BE RELEVANT TO UNDERSTANDING HOW AN IBC CAME TO THE DETERMINATION OF THE APPROPRIATE LEVEL OF CONTAINMENT FOR A PARTICULAR PROTOCOL SHOULD BE INCLUDED IN THE MINUTES OF THOSE MEETINGS. SO, THEREFORE, IT SEEMS TO BE TO BE OBVIOUS I'M A BIT CONCERND THAT THIS WASN'T MENTIONED IN THE COMMITTEE DISCUSSION THAT THE MINUTES THEMSELVES OF THE MEETINGS SHOULD FORM AN IMPORTANT BASIS ON WHICH IBCs CAN EXCHANGE INFORMATION ABOUT HOW THEY HAVE GONE ABOUT ASSIGNING THE APPROPRIATE CONTAINMENT LEVELS FOR A PARTICULAR PROTOCOLS, PARTICULARLY THE KIND OF PROTOCOLS THAT WE ARE TALKING ABOUT NOW WHICH WOULD INVOLVE IN ALMOST ALL CIRCUMSTANCES FULL COMMITTEE REVIEW AND WHICH WOULD INVOLVE RATHER MORE DETAILED DISCUSSIONS THAN IF IT WERE A MORE ROUTINE TYPE OF MATTER. THE SECOND OBSERVATION.

DO YOU A QUESTION? LET ME JUST SAY SOMETHING ABOUT THAT POINT, FIRST OF ALL. THOSE ARE -- I -- I -- I THINK ANYBODY WHO IS INVOLVED IN IBCs WOULD AGREE WITH ALL OF THOSE COMMENTS. AND THOSE -- THAT IS -- THAT IS EXACTLY WHAT IBCs ARE SUPPOSED TO DO FOR ALL RECOMBINANT DNA TYPE EXPERIMENTS AND THE PROCEDURE MOST IBCs GO THROUGH TO DETERMINE THE CONTAINMENT LEVEL OR MOST BIOSAFETY OFFICERS GO THROUGH IS USUALLY A RATHER SIMPLE ONE BECAUSE MOST ARE STRAIGHTFORWARD. THE WORST YOU CAN DO WITH RECOMBINANT DNA IS WORK WITH THE WILD-TYPE ORGANISM. THAT IS RATHER SIMPLE. HERE WE HAVE THIS MEETING IS -- THIS MEETING HERE IS TO PROVIDE IBCs GUIDANCE TO WORK ON THESE DEADLY ORGANISMS THAT THERE IS NOT A CLEAR -- A CLEAR WAY -- WHERE THERE IS NOT A CLEAR WAY FOR THEM TO TELL HOW TO MAKE THAT ASSESSMENT. THAT IS WHAT WE ARE TRYING TO COME UP WITH HERE.

OKAY.

SO WE WANT -- THE FLOOR IS NOT SUPPOSED TO BE OPEN FOR PUBLIC DISCUSSION AT PRESENT. WHAT WE ARE TRYING TO DO HERE IS LIMIT THE DISCUSSION TO SIMPLY PROVIDING IBCs GUIDANCE FOR WORKING WITH HIGHLY PATHOGENIC ORGANISMS.

PERHAPS I MISSPOKE. THE DISCUSSION WAS HOW TO ESTABLISH A MECHANISM FOREX CHANGE OF INFORMATION AND MY POINT WAS THAT IN VIEW OF THE FACT THAT REVIEW OF THESE PROTOCOLS REQUIRES FULL COMMITTEE AND REQUIRES THAT THE COMMITTEE GO OVER ALL OF THESE CONSIDERATIONS PRESUMABLY. OF THAT INFORMATION WOULD BE REFLECTED IN THE MINUTES SO MY SUGGESTION IS THAT THE RAC WOULD CONSIDER THE MINUTES TO BE AN IMPORTANT MECHANISM FOR THE EXCHANGE OF THE TYPE OF INFORMATION THAT WAS PUT DOWN IN GENERAL POINTS. THE SECOND OBSERVATION WAS THAT I -- WHILE DR. DeLUCA YOU WERE, OF COURSE, I THINK TECHNICALLY CORRECT IN SAYING THAT THE RAC CAN'T MANDATE COMPLIANCE -- THAT'S -- THE ACTUAL SITUATION IS A LITTLE MORE COMPLICATED BECAUSE, OF COURSE, NIH POLICY, USDA REGULATION, DOE RULE AND PROBABLY SOME OTHER THEY'S CAN'T THINK OF RIGHT NOW, OF COURSE, REQUIRE RECIPIENTS OF FUNDING TO MAINTAIN IBCs THAT ARE COMPLIANT. SO WHEN WE ARE TALKING ABOUT THIS I'M A BIT CONCERNED AT THE CONSISTENT RETREAT FROM ASSERTIVENESS ABOUT GOING ABOUT THE IMPLEMENTATION OF THESE RECOMMENDATIONS BY SAYING THAT WE CAN'T MANDATE OR WE CAN'T SORT OF COMPEL WHILE IN FACT GIVEN THE STRUCTURE OF RESEARCH FUNDING THE RAC DOES HAVE SIGNIFICANT ABILITY TO ENSURE THAT THESE RECOMMENDATIONS WOULD BE TAKEN ONBOARD OR, INDEED, ANY OTHER PROVISION THAT IS DEVELOPED UNDER THE GUIDE LINES.

ALL RIGHT. WE WILL TAKE ONE MORE COMMENT IF IT IS RELEVANT.

JUST VERY BRIEFLY. MY NAME IS MIKE HAHN. THE BIOSAFETY OFFICER WITH UNIVERSITY OF MICHIGAN AND EX OFFICIO ON THE IBC. I WANTED TO MENTION BRIEFLY THE COPING MECHANISMS FOR LARGE INSTITUTIONS THERE ARE OPPORTUNITIES THAT ARE AVAILABLE AT LARGE INSTITUTIONS THAT AREN'T AVAILABLE AT SMALLER ONES LIKE WE HAVE A CORE LABORATORY THAT PRODUCES AID KNOW VIE ROW VEKT VECTORS FOR THE RESEARCH COMMUNITY AND IT WAS SET UP TO CREATE A GOLD STANDARD FOR PRODUCTION IN OPERATIONS AND TECHNIQUES AND CONTAINMENT FOR BL2 VECTORS FOR HUMAN GENE TRANSFER AND THAT HAS BEEN AN OPPORTUNITY FOR US TO PARTNER WITH THEM FROM THE OX PAIKSAL SAFETY AND HEALTH OUR DEPARTMENT IS FUNDED FOR OVERHEAD TO PROVIDE PROVIDE TRAINING FOR BIOSAFETY TO THE CAM PUTS. WE NEEDED AN ACADEMIC AND RESEARCH BACK BOHN SO WITH THE IBC SANCTION WE ARE ABLE TO PARTNER WITH THE CORE LAB AND COME UP WITH THE CURRICULUM WITH THE GOLD STANDARDS FOR THE BMBL AND NIH GUIDELINES ALONG WITH THE ACADEMIC AND PRODUCTION PERSPECTIVE OF A CORE LABORATORY THAT IS FUNDED IN PART OF THEIR CHARGE IS TO PROVIDE THOSE OUTREACH SERVICES TO ROOT RESEARCH COMMUNITY SKWR S. IT HAS BEEN A SUCCESSFUL PROGRAM IN THAT IT IS FUNDED OUT OF OUR DEPARTMENT ON BEHALF OF THE IBC TO SUPPORT THE UNIVERSITY'S RESEARCH COMMUNITY AND NOT ONLY THE PRODUCTION OF THE VECTORS FOR POTENTIAL HUMAN GENE TRANSFER AND PRECLINICAL WORK BUT ALSO TO PROVIDE THAT TYPE OF TRAINING FROM THE LABORATORY DIRECTOR GIVES THE TRAINING IT IS A FOUR HOUR SESSION AND GIVEN EVEN REGULAR BASIS AND IT HAS BEEN VERY POPULAR. IT HAS BEEN MUCH MORE WELL RECEIVED BY THE RAOARJ OMMUNE RESEARCH COMMUNITY THAN WE EXPECTED AND WE HAVE TO COME UP WITH LARGER VENUES TO HOLD THIS BECAUSE PEOPLE WANT THE STAFFS TRAINED AND DON'T HAVE THE BACKGROUND TO DO THE WORK SAFELY. THAT IS BL2, SMALL STEPS. ONCE YOU START GETTING INTO THE MORE BIOHAZARDOUS MATERIALS THEN YOU HAVE TO STEP UP THAT TYPE OF PROGRAM SO MY RECOMMENDATION IS THAT YOU START LOOKING AT THESE SIMPLE BL2 TRAINING MECHANISMS FOR PEOPLE WHO COME FROM MB BACK GROUNDS AND DON'T HAVE THE MYCOBIOLOGY AND THEN STEP UP FROM THERE TO SOME OF THESE HIGH CONTAINMENT OPERATIONS.

OKAY. ANY MORE COMMENT ON THE GENERAL POINTS?

I -- MY OPINION IS IT IS THE RESPONSIBILITY OF THE PI. I HAVE BEEN RUNNING A BL3 LAB FOR THE PAST 30 YEARS. I WAS TRAINED IN AGRICULTURE AND THEN TRAINED SEVERAL OF THE PEOPLE AT THE TABLE. AND IT IS MY RESPONSIBILITY TO TAKE WHAT I'M DOING TO THE IBC AND SO WE CAN'T MOVE THIS TO THE INSTITUTION. I CAN'T MOVE THIS TO MY INSTITUTION. I HAVE TO BE RESPONSIBLE FOR THE TRAINING OF THE PEOPLE WE HAVE COURSES AND WE HAVE SOPs AND THE -- ALL THE STAFF MUST BE TRAINED AS APPRENTICES UNTIL THE REST OF THE STAFF FEEL COMFORTABLE WITH THESE PEOPLE BEFORE THEY ARE TURNED LOOSE SO I CAN'T MOVE THIS RESPONSIBILITY FROM ME TO MY INSTITUTION. AND SO I HAVE TO CONVINCE THE IBC THAT I HAVE DONE A PROPER JOB AND THE IBC NEEDS TO LOOK AT ME AND SEE THAT I HAVE DONE SO.

I THINK -- LET ME JUST AGREE WITH -- AGREE WITH THAT THAT WHAT YOU ARE TALKING ABOUT IS THE AGE OLD PROCESS OF MEANTORING STUDENT -- MENTORING STUDENTS AND POST DOCS INTO PROPERLY WORKING IN THE LABORATORY AND TEACHING THEM. AND DONE AT A HIGHER LEVEL. I GUESS THE ONLY QUESTION THAT REMAINS HERE IS WHAT TO DO WITH THESE CONTAINMENT AREAS THAT ARE MORE LIKE CORE FACILITIES. WHERE THERE WILL BE A LOT OF PEOPLE WORKING IN ONE CORE, A LOT OF DIFFERENT GROUPS WORKING IN A CORE IN A CONTAINMENT FACILITY LIKE THE ONE THAT WAS DESCRIBED MICKEY OR THE ONE IN BOSTON. I DON'T IMAGINE THAT THERE IS MANY PEOPLE OTHER THAN YOU WORKING IN YOUR -- YOUR FACILITY, IS THAT --

AGREED. BUT AGAIN, THE -- AT THIS FACILITY THERE IS GOING TO BE A NUMBER OF PRINCIPAL INVESTIGATORS AND THEY AGAIN HAVE TO TAKE RESPONSIBILITY FOR.

I AGREE.

-- IN THEIR PROGRAMS. BUT I THINK THIS IS A VERY IMPORTANT ISSUE TO GET INTO THE DOCUMENT. TRAINING IS ABSOLUTELY ESSENTIAL. YOU CAN BUILD THE WORLD-CLASS BL WHATEVER, BUT UNLESS YOUR STAFF ARE TRAINED AS WE HAVE SEEN IN CHINA AND TAIWAN -- UNLESS THE STAFF ARE TRAINED, WE WILL HAVE ACCIDENTS.

AND I THINK IT IS IMPORTANT TO INCLUDE THAT THE TRAINING BE PRACTICAL AS WELL AS THEORETICALAL. NOT SIMPLE.

GOING TO A CLASS AND HAVING PEOPLE TALK TO THEM BUT SOMETHING THAT IS A PROGRAM IN THE LABORATORY WHERE THEY ARE ACTUALLY APPRENTICED IN FOR LACK OF A BETTER WORD AND ACTUALLY WORK IN THE LABORATORY AND HAVE OVERSIGHT THERE.

WHILE WE ARE TALKING ABOUT TRAINING LET'S MOVE ON TO THE NEXT PAGE, EDUCATION AND TRAINING. THESE ARE SOME OF THE POINTS THAT WERE BROUGHT UP. THIS IS WHERE IS COULD PERHAPS EMPHASIZE THE RESPONSIBILITIES OF THE PI.

THESE TRAINING THINGS ON THIS PAGE DEAL WITH WHAT TO DO IN CASE OF AN INCIDENT AND WHO AND HOW SHOULD RESPOND TO THE INCIDENT AND WHO SHOULD BE TRAINED IN ADVANCE AND WHO SHOULD BE CONTACTED AND HOW WILL PEOPLE KNOW WHAT THE -- THE CHAIN OF EVENTS IS THAT SHOULD OCCUR IF SOMEONE WHO IS WORKING WITH A HIGH PATHOGEN BELIEVES THEY MAY HAVE BEEN INFECTED OR SOMEONE ELSE IS CONCERNED ABOUT A BREAK-IN -- BREAK IN PROCESS. I THINK THAT THAT PROBABLY NEEDS A -- A LITTLE DIFFERENT TITLE, THE OCCUPATIONAL MEDICINE SERVICES I THINK IS WHAT WE ARE CONSIDERING HERE. AND I THINK THAT THIS HAS BEEN SOMETHING THAT PERHAPS IBCs HAVE NOT CONSIDERED IN -- IN DEALING WITH MANY OF THE PROTOCOLS. THEY HAVE DEALT WITH WHAT WILL HAPPEN IN THE LABORATORY AND I THINK IT IS CLEAR THAT THE EXTENSION OF WHAT HAPPENS IN THE LAB HAS TO INCLUDE WHAT HAPPENS IF THERE IS A PROBLEM. AND I THINK THIS REALLY LAYS OUT IN A VERY CLEAR WAY WHO ARE THE PEOPLE WHO NEED TO BE INFORMED AND HOW THAT COORDINATION NEEDS TO BE PLANNED. ANY COMMENTS FROM THE COMMITTEE ON THIS PAGE?

I JUST WANT TO POINT OUT THAT AS PART OF THE DOCUMENT I TALK ABOUT THE ATTACHED DOCUMENT ENTITLED OCCUPATIONAL MEDICAL SERVICES FOR BIOMEDICAL RESEARCH PROVIDED BY DOCTOR SCHMITT AS AN EXAMPLE OF THE NIH PROCESS AND AS I SAY, AS THE POINTS TO CONSIDER SAY, IT IS AN EXCELLENT SET OF CONSIDERATIONS AND THE ONES THAT ARE BULLETED HERE WERE PART OF THE DISCUSSION LAST NIGHT THAT SORT OF FLESH OUT SOME MORE SOME OF THE ISSUES AND SOME OF THE POINTS THAT -- THAT MAY WANT TO BE CONSIDERED IN TALKING ABOUT A PLAN.

MAYBE THIS WOULD BE A PLACE, THOUGH TORTION EM-- TO EMPHASIZE THE RESPONSIBILITY OF THE PI FOR TRAINING. I COULD SEE IT STARTING WITH EMPHASIS ON TRAINING AND SAFE LABORATORY METHODS. AND THE PI IS THE ONE THAT IS GOING TO ASSUME THAT RESPONSIBILITY AND THEN HAVE A CATEGORY OF EMERGENCY RESPONSEN PLANNING WHICH IS DEALING HERE WITH HOW DO YOU RESPOND TO EVENTS THAT DO GO AWRY BUT EMPHASIZING FIRST THE IMPORTANCE OF TRAINING AND SAFE LABORATORY METHODS THAT RELATE TO THE PROTOCOLS THAT ARE BEING CARRIED OUT WHICH PRESENT THE HAZARDS EVER EXPOSURE IF PEOPLE ARE NOT WELL PREPARED OR IF ACCIDENTS OCCUR AT THE TIME.

THE CONCERN THAT I HAVE HERE AND I AGREE WITH WHAT DR. WEBSTER MENTIONED IS THAT I WOULD ASSUME WE WILL SEE MORE PIs BECOMING ATTRACTED TO THIS KIND OF WORK AND THEY MAY NOT ALL HAVE BEEN PREPARED PROPERLY TO REALLY PROVIDE THE TRAINING THAT THEIR STAFF WILL NEED EVEN IF THEY ARE DOING THEIR BEST AND SO AN ADDITIONAL MECHANISM TO BE SURE THAT PIs ARE REALLY AWARE OF WHAT THEY NEED TO BE DOING I THINK IS IMPORTANT. I THINK THIS WAS ALSO MENTIONED BY SOMEONE ELSE WHO RAISED CONCERNS ABOUT SOME OF THE SMALLER ORGANIZATIONS AND I THINK WE NEED TO MAKE SOME STATEMENT ABOUT THIS.

I WOULD TAKE DOCTOR ROZEN BERGS'S COMMENTS ONE STEP FURTHER IN THAT I DID -- THE IBCs I SIT ON COME FROM RATHER LARGE TUBES WHERE WE HAVE ADDITIONAL STAFF TO PROVIDE TRAINING AND OVERSIGHT AND SO FORTH. AND I SEE A SPECTRUM OF HOW PIs REGARD THE TRAINING PROCESS. THERE ARE SOME THAT REALLY TAKE ON THE ROLE AS DR. WEBSTER DESCRIBED IT. IT IS MY RESPONSIBILITY, I NEED TO THINK ABOUT THE PLAN. I NEED TO ENSURE THAT THE PEOPLE THAT I ALLOW INTO MY LAB HAVE REALLY GONE THROUGH IT. BUT THE OTHER END OF THE SPREK TRAUMA IS WE HAVE A LARGE INSTITUTION AND -- SPECTRUM IS WE HAVE A LARGE INSTITUTION AND THERE ARE PEOPLE TO TAKE CARE OF THIS AND SOMETIMES I WONDER IF THE PI IS AS KNOWLEDGEABLE OR WELL TRAINED AS THE TECHNICIAN THAT HE IS PUTTING INTO THE LAB. AND I THINK IT IS IMPORTANT TO RAISE TO THE CONSCIOUS SS OF THE IBCs THAT THEY NEED TO BE CONVINCED THAT THE PI IS AN ACTIVE THOUGHTFUL MEMBER OF THE CREATION OF THE SAFETY PLANS CONTAINMENT PLANS AND TRAINING PLANS. THAT IT IS NOT JUST, OKAY, WE HAVE A BIOSAFETY OFFICER, TRAIN MY PEOPLE, AND THEN TELL ME WHEN THEY CAN GO INTO THE FACILITY. BUT THAT THEY REALLY HAVE BEEN -- EVEN IF THEY ARE RELYING ON THE INSTITUTIONAL TRAINERS THAT THEY HAVE ACTUALLY INTERACTED WITH THOSE PEOPLE AND HAVE THOUGHT ABOUT AND INFORMED THESE PEOPLE INTO COMING FORTH WITH A PLAN FOR CONTAINMENT, FOR LAB PRACTICES, AND FOR EMERGENCY PROCEDURES IN CASE OF AN ACCIDENT. AND I THINK IT NEEDS TO BE MADE EXPLICIT IN OUR RECOMMENDATIONS.

I THINK EVERYBODY IS RIGHT. I THINK THERE IS A PIECE OF THIS FOR EVERYONE. AND IT IS MORE OF A -- I THINK WE COULD TAKE A STEP BACK AND LOOK AT THIS AND -- IN KIND OF A SYSTEMS APPROACH. THERE ARE RESPONSIBILITIES THAT FLOW FROM THE TOP OF THE INSTITUTION DOWN. AND ONE OF THOSE ARE SETTING POLICIES AND PROCEDURES FOR EDUCATION AND TRAINING OF PERSONNEL AT ALL LEVELS WHETHER THEY ARE STUDENTS OR WHEN THEY ARE MAINTENANCE PERSONNEL OTHER WHAT -- OR WHAT HAVE YOU, EMERGENCY RESPONSE PERSONNEL. AND SO CERTAINLY THERE IS A ROLE FOR THE INSTITUTION AND INSTITUTION-WIDE TRAINING PROGRAMS BECAUSE EACH INSTITUTION HAS A VERY SITE-SPECIFIC REQUIREMENTS. LOCAL REQUIREMENTS. LOCAL PRESSURES. LOCAL RELATIONSHIPS WITH THEIR PUBLIC AND THEIR COMMUNITY. AND THOSE KINDS OF EXPECTATIONS, HOW YOU GET RID OF YOUR MEDICAL WASTE, WHAT THE EXPECTATIONS FOR THE BEHAVIOR ARE AND OPERATING YOUR LABORATORIES ARE CERTAINLY INSTITUTIONAL RESPONSIBILITIES. I LIKE TO CALL THE -- A GENERAL COURSE LIKE THAT HOW TO LIVE AND SURVIVE AT HARVARD OR HOW NOT TO REALLY GET INTO TROUBLE. AND THOSE -- THE EXPECTATIONS HAVE TO BE VERY CLEAR ON AN INSTITUTIONAL LEVEL. THERE IS NO WAY, HOWEVER, THAT AN INSTITUTION CAN TRAIN INDIVIDUAL RESEARCHERS IN A PARTICULAR BIOSAFELY LEVEL 3 LABORATORY. AS I WILL TELL YOU, DOCTOR SUBBARAO BY A SAFETY LEVEL 3 LABORATORY IS DIFFERENT AND HAS DIFFERENT PROCEDURES THAN OTHER BIOSAFETY LEVEL 3 LABORATORIES BECAUSE OF THE PROTOCOL DRIVEN RISK ASSESSMENT. I WOULD SUGGEST THAT WE -- AND DR. WEBSTER IS TRUE, THE BUCK STOPS THERE. HE IS RESPONSIBLE FOR WHAT GOES ON IN HIS LABORATORY AND THE SPECIFIC PROTOCOL AND PROTOCOLS THAT ARE USED FOR HIS LABORATORY AND HIS SPECIFI RESEARCH. THERE ARE MANY LEVELS ARE TRAINING THAT ARE REQUIRED TO HAVE A SUCCESSFUL TRAINING PROGRAM AT YOUR INSTITUTION NO MATTER HOW LARGE OR HOW SMALL AAHOR AND IT STARTS WITH INSTITUTIONAL POLICIES, REQUIREMENTS, EXPECTATIONS AND SERVICES THAT MUST BE PROVIDED TO SUPPORT THE PI. A BASIC DESCRIPTION OF WHAT THOSE EXPECTATIONS ARE. AND THEN CERTAINLY VERY, VERY SPECIFIC RESPONSIBILITIES THAT -- AND WITH -- DON'T END WITH THE PI. THEY PERHAPS IN PROTOCOL-SPECIFIC START WITH THE PI BUT THERE ARE ALSO RESPONSIBILITIES THAT GO IN THE HIERARCHY BELOW THE PI. THERE ARE EXPECTATIONS FOR BEHAVIOR. THERE ARE EXPECTATIONS FOR CONDUCT. IT IS NOT JUST THE PI. IT AS WHOLE SYSTEMS APPROACH AND THE NEED FOR EDUCATION AN TRAINING IS AT EVERY LEVEL AND EVEN WITH THE EMPLOYEES. THEY ARE EXPECTED, THEY HAVE TO BE TOLD AND TRAINED AND INFORMED AS TO WHAT THEIR EXPECTATIONS, WHAT THE INSTITUTION'S EXPECTATIONS OF THEM IS OR ARE -- ARE. AND THAT IS VERY, VERY IMPORTANT. AND SO WE NEED TO CONSIDER THE ENTIRE PYRAMID, I BELIEVE.

ANY MORE COMMENTS?

THERE WAS ONE OTHER COMMENT ABOUT THIS SECTION, EDUCATION AND TRAINING. THERE WAS ONE IDEA THAT HAD OPINION RAISED THAT I WASN'T SURE MADE IT ON HERE WHICH WAS ABOUT COMMUNICATION, PRIOR PLANNING WITH THE OCCUPATIONAL HEALTH PROVIDER TO ENSURE THAT THEY HAVE THE FAMILIARITY THAT THEY NEED TO HAVE OR THAT THEY HAVE THE RESOURCES THAT THEY CAN REFER TO, TO RESPOND TO ISSUES, SITUATIONS THAT MIGHT COME UP DEPENDING ON THE AGENTS THAT ARE BEING WORKED WITH. THERE IS -- AS WITH ALL OF THESE THINGS THERE IS UNEVENNESS IN THE DEGREE OF PREPARATION THAT OH PROGRAMS MAY HAVE, ESPECIALLY THIRD-PARTY PROGRAMS.

I BELIEVE THAT THAT POINT IS COVERED IN THAT SUPPLEMENTAL SECTION AT THE VERY END OF YOUR HANDOUT. IT IS A CRITICAL POINT.

OKAY.

I THINK WE SHOULD MOVE ON TO THE NEXT ISSUE WHICH IS SURVEILLANCE AND WE TALKED YESTERDAY A GOOD DEAL ABOUT TAKING BLOOD SPECIMENS TO SERVICE INDICATORS OF -- TO SERVE AS INDICATORS OF WHETHER SOMEONE HAD BEEN INFECTED WITH A PATHOGEN FROM THE LABORATORY AND THIS OUR BELIEF WAS IN RESPONSE TO THAT THERE WAS SOME QUESTION ABOUT WHETHER IT WAS LEGAL TO TAKE THEM, WHO SHOULD TAKE THEM, WHAT SHOULD BE DONE WITH THEM AND THIS SECTION IS ATTEMPTING TO PROVIDE GUIDANCE IN THAT REGARD. SO, IT SHOULD BE CLEAR THAT THESE PROGRAMS CAN'T BE MANDATED, YOU CAN'T FORCE SOMEONE TO GIVE YOU A BLOOD SAMPLE BUT ON THE OTHER HAND, AS WAS STATED YESTERDAY IF ONE -- SOMEONE WISHES NOT TO PARTICIPATE IN THE PROGRAM IT IS WITHIN THE PURVIEW OF THE PI TO SAY YOU CAN'T GO INTO THE BL3 AND WORK WITH THIS AGENT ZWLA IS ANOTHER POSSIBILITY, I BELIEVE. AND INSTITUTIONS ARE ENCOURAGED TO IMPLEMENT THESE PROGRAMS, INCLUDING A BASELINE BLOOD SAMPLE BEFORE WORKING WITH THE AGENT WHICH WOULD BE COLLEG -- COLLECTED BY AN OCCUPATIONAL HEALTH STAFF AND STORED BY THEM BUT I THINK WE ALSO HAVE THE RESPONSIBILITY FOR INFORMED CONSENT WHEN THE BLOOD SAMPLE IS TAKEN, WHEN EACH BLOOD SAMPLE IS TAKEN SO PEOPLE KNOW WHAT CAN BE DONE WITH THEM AND WHAT USES THEY WILL BE PUT TO AND THAT IN FACT THEIR NAMES WILL REMAIN ASSOCIATED WITH THESE AGENTS. SO WE HAVE TO INVOLVE OUR IRBs IN THIS AS WELL, I BELIEVE. AND THIS REFERS ONLY TO THE BASELINE GOOD SAMPLE AND ROUTINE PACK FIES IN -- PRACTICE IN OUR INSTITUTION HAS BEEN TO TAKE YEARLY OR TWICE YEARLY SPECIMENS AND STORE THEM TO PROVIDE MORE UP-TO-DATE SAMPLES IN CASE SOMEBODY HAS AN INCIDENT. ANY ADDITIONAL COMMENTS ON THIS? YES?

ON -- IN LOOKING AT THE OCCUPATIONAL MEDICAL SERVICES DOCUMENT AT POINT F WHERE IT SAYS MEDICAL SUPPORT SERVICES AND INJURY DATA SHOULD BE EVALUATED ANNUALLY, I WOULD SUGGEST THAT THE WORDS "AT LEAST ANNUALLY" BE INSERTED THERE BECAUSE IN TERMS OF REALLY BEING PROACTIVE AND PLACING INTERVENTIONS IN PLACE TO BRING ACCIDENT INJURY RATES DOWN YOU REALLY NEED TO BE DOING MORE THAN A CUR SORRY ANNUAL REVIEW. YOU SHOULD BE ACTIVELY LOOKING AT YOUR PROGRAMS. I THINK JUST INSERTING THOSE TWO WORDS WOULD HELP IMPORT THAT.

A COMMENT. I THINK THAT IT IS CONFUSING TO LINK OBTAINING A SERUM SAMPLE FOR STORAGE WITH SURVEILLANCE. IT IS NOT REALLY SURVEILLANCE. IT AS MEDICAL SUPPORT SERVICE. SURVEILLANCE WOULD IMPLY THAT YOU ARE GOING TO BE TESTING IN SOME FASHION TO SURVEY TO SEE IF SOMETHING HAS HAPPENED. INSTEAD YOU'RE SIMPLY STORING A POTENTIAL RESOURCE FOR THE FUTURE. I WOULD CLASSIFY TOWARDS THE END OF OX OCCUPATIONAL MED SAL SERVICES AS ONE OF THE TESTS OR ONE OF THE SERVICES TO BE OFFERED BY YOUR SUPPORT MEDICAL SERVICES.

I BELIEVE THERE IS ALSO A COMMENT MADE YESTERDAY, THOUGH, I DON'T SEE IT IN HERE, THAT ONLY APPROVED TESTS SHOULD BE USED FOR THESE. IS THAT PART OF YOUR DOCUMENT?

THE POINT WAS FOR ROUTINE TESTING WHETHER PREPLACEMENT OR DURING THE COURSE OF IMPLEMENT THAT IS NONINCIDENT DRIVEN EITHER EXPOSURE OR SYMPTOMS YOU SHOULD LIMIT YOUR TESTING TO COMMERCIALLY AVAILABLE TESTS. IF YOU ARE EXPLORING A POTENTIAL LABORATORY ACQUIRED INFECTION OR AN EXPOSURE, YOU MAY WANT TO GO BEYOND THOSE LIMITS.

DO YOU WANT THAT TO BE IN HERE, DR. SCHMITT?

IT NS THAT ATTACHMENT AT THE END. IT IS MENTION.

ANY ADDITIONAL COMMENTS?

IF SOMEBODY ACTUALLY WANTED TO DO SURVEILLANCE WHICH WAS TO LOOK FOR THE OCCURRENCE OF INADVERTENT OR UNRECOGNIZED TRANSMISSION OF AN AGENT FROM A HOOD TO A LABORATORY WORKER AND IF THESE SERUM SPECIMENS THAT ARE COLLECTED ARE NOT TO BE USED FOR THAT PURPOSE F THAT WAS A GOAL OR DESIRE WOULD THAT HAVE -- SIMPLY BE DONE UNDER A RESEARCH PROTOCOL AND REQUESTING SPECIFIC SPECIMENS? IS THAT HOW THAT WOULD BE HANDLED?

IF COY MENTION THAT AT THE NIH -- IF I COULD MENTION AT THE NIH WE DO HAVE A RATHER LARGE REPOS EITFERRY FOR SERUM SAMPLES AND SPECIFIES WHAT CAN BE TON WITH THE RESULT. WE HAVE USED OUR SERUM STORAGE PROGRAM FOR WHAT WAS IN ESSENCE RESEARCH, LOOKING FOR MARKERS FOHIV IN THE MID 3/08S AND WE STRIPPED THE IDENTIFIERS FROM THE SERUM SPECIMEN SO AS TO BLIND THEM AND RETAINED MORE THAN ENOUGH FOR OUR FUTURE NEEDS BEFORE GIVING THESE TO THE RESEARCHERS BUT IT WAS ALWAYS DONE THROUGH A RESEARCH PROTOCOL.

THAT WAS GOING TO BE MY POINT, IS THAT WE HAVE TO BE VERY CAREFUL THAT WE DON'T LOOK FOR SOMETHING AND THEN WE CAN'T TELL THE EMPLOYEE IF WE FIND A BLIP WHAT IT MEANS AND WHAT THE IMPACT IS ON THEIR FUTURE HEALTH. AND YOU KNOW, WE CAN'T HAVE DID ASH YOU KNOW, AN ASSAY LOOKING FOR A DISEASE IN ROUTINE MEDICAL SURVEILLANCE. WE HAVE -- THIS IS A SURVEILLANCE PROGRAM IS A CLINICAL PROGRAM. IT AS MEDICAL PROGRAM. AND HAS TO ABIDE BY ALL ATTENDANT STANDARDS ARE MEDICAL PRACTICE. SO TO DO WHAT YOU ARE SUGGESTING, WHICH I KNOW INTELLECTUALLY ENTISES US ALL, WE WOULD, INDEED, HAVE A WRITE A RESEARCH PROTOCOL AND GO THROUGH AN IRB AND YOU WOULD HAVE TO GET RELEASE FROM PARTICIPANT.

THAT IS REALLY THE ONLY WAY THAT THAT TYPE OF ACTIVITY. IT WAS TALKED ABOUT HOW MANY LABORATORY ACCIDENTS THERE ARE. TO GET A BASE OF INFORMATION LIKE THAT WOULD YOU YOU WOULD HAVE TO COLLECT THIS TYPE OF INFORMATION IN THIS FORM MATT BUT THAT WOULD HAVE TO BE PROTOCOL DRIVE ONE CONSENT FORMS AND ET CETERA.

EXACTLY.

RIGHT.

AND WE WOULD HAVE TO BE ABLE TO TELL PEOPLE --

RIGHT.

-- WHO PARTICIPATED WE MIGHT NOT KNOW WHAT THE RESULTS MEAN OR WHAT THE IMPACT IS ON THEIR PERSONAL HEALTH.

RIGHT.

ONE OF THE HANDOUTS FOR THIS MEETING INCLUDED AN ARTICLE WRITTEN BY TOM FOULKE AT THE CDC AND THIS WOULD BE THE EXAMPLE OF A TEST LOOKING FOR THE DISEASE. AND WHEN IT WAS PROPOSED ON MORE THAN ONE OH OCCASION TO THE NIH THE POSITION OF THE NIH WAS THAT IS RESEARCH. IF WHAT YOU ARE DOING IS CONDUCTING RESEARCH YOU NEED TO TAKE THIS THROUGH AN APPROPRIATE IRB AND SOLICIT VOLUNTEERS WHETHER EMSO EMPLOYEES OF THE THROUGH A. WE NEED TO BE CAREFUL IN PROVIDING MEDICAL SUPPORT SERVICES FOR WORKERS THAT WE UNDERSTAND THAT THAT IS WHAT THEY ARE RECEIVING AND THEY ARE NOT BEING AN UNWITTING PARTICIPANT IN SOME FORM OF RESEARCH.

I WOULD LIKE TO COMMENT ON THE USE OF THE WORD COMMERCIAL RATHER THAN WHAT I THINK IS A VALIDATED ASSAY. THERE ARE SOME ASSAYS THAT MAY BE VERY GOOD THAT MAY NOT BE CORPORATE SPONSORED THAT MAY HAVE A REFERENCE LAB THAT MIGHT BE AN ACADEMIC LAB THAT IS USED FOR DIAGNOSIS THAT HAS BEEN DONE FOR MANY YEARS FOR THINGS SUCH AS LIDINOL. MAYBE IT COULD BE A GOOD ASSAY THAT HAS BEEN VALIDATED BUT IT MAY NOT BE A COMMERCIAL ASSAY AND THAT WOULD STILL BE APPROPRIATE IF YOU ARE DOING FOR MEDICAL DIAGNOSIS IN SOME CASE.

I WOULD PREFER THAT WE USE PERHAPS THE TERM FDA-APPROVED THEN. BECAUSE ALTHOUGH ONE LABORATORY MAY BE CONFIDENT OF THEIR RESULTS I'M NOT CERTAIN THAT THAT COULD BE EXTENDED AND ONCE YOU OPEN THAT DOOR I'M NOT SURE WHAT THE LIMITS ARE ON THAT. AGAIN, I THINK THIS IS AN INSTITUTION-BASED DECISION ON HOW THEY ARE GOING TO DO THINGS. MY STRONG PREFERENCE WOULD BE THAT THE TESTING THAT YOU OFFER AND A ROUTINE BASIS BE FDA APPROVED.

THAT WOULD MEAN THAT YOU COULDN'T DO TESTING FOR EMERGING PATHOGENS THEN BECAUSE MOST OF THOSE WOULD BE THINGS THAT ARE BEING DEVELOPED IN THE RENCH LAB RESEARCH LABS.

THAT'S CORRECT.

I DON'T AGREE. I'M NOT SURE I AGREE WITH THAT POINT.

I THINK THAT YOU REALLY WOULD NEED TO MAKE A DISTINCTION HERE BECAUSE IF YOU ARE DEALING WITH VIRUSES THAT JUST REMERGED LIKE SARS WHERE THERE ARE NO COMMERCIAL ESTS AND YOU HAVE A LABORATORY WORKER THAT DEVELOPS A SARS-LIKE ILLNESS THAT IS A DIFFERENT SITUATION. YOU WOULD WANT TO DO VIRUS ISOLATIONS ON THAT INDIVIDUAL AND TAKE SERUM SAMPLES AND ANTIBODY ASSAYS NONE OF WHICH ARE COMMERCIALLY AVAILABLE. THAT HAS TO COME UNDER SOME KIND OF DIFFERENT --

MY POINT WAS FOR ROUTINE TESTING, EVERY SIX WEEKS OR SIX O MONTHS OR YEAR OR WHATEVER THAT THE ROUTINE TESTS BE FDA APPROVED. IN THE CASE OF AN EXPOSURE OR SYMPTOMS SUGGESTIVE OF A PROBLEM ALL HOLDS ARE OFF.

I WANTED TO CLIER FIE CLARIFY THAT.

OUR OCCUPATIONAL MEDICAL PROVIDERS ARE LICENSED PHYSICIANS AND HAVE A MEDICAL PRACTICE. THEY ARE HELD TO CERTAIN STANDARDS OF CARE. AND THAT DOESN'T CHANGE BECAUSE YOU ARE IN A RESEARCH ENVIRONMENT. YOU ARE STILL PROVIDING MEDICAL CARE AS A LICENSED PHYSICIAN. AND THE STAN THE STANDARDS OF CARE DON'T CHANGE AND I THINK THAT THAT IS THE POINT THAT WE ARE TRYING TO MAKE HERE IN TERMS OF THE SURVEILLANCE PROGRAMS. THEY ARE MEDICAL PROGRAMS AND MEDICAL SERVICES. AND THEY ARE VERY DISTINCT AND DIFFERENT FROM THE RESEARCH ENVIRONMENT.

THAT IS EXACTLY THE POINT THAT IS TRYING TO BE MADE. AND ONE OF THE THINGS JUST AS A HISTORICAL EXAMPLE POST EXPOSURE PRO FA LAX IS FOR HIV WHEN THE ONLY DRUG AVAILABLE WAS AZ T IT WAS LICENSED FOR USE AS A PROPHYLACTIC AGENT. THERE WAS STUDIES DONE BY SEVERAL RESEARCHERS USING MICE AND CATS AND ANALOGOUS AND IT WAS SHOWN THAT THAT MEDICATION MAY HAVE SOME BENEFIT BUT IT WAS NOT APPROVED AND HAD NOT BEEN STUDIED IN HUMANS AND YET SEVERAL OF US WENT AHEAD AND PRESCRIBED IT BUT IT WAS A DIFFICULT POSITION FOR THE INSTITUTION TO BE IN TO BE BLESSING THAT ACTION AT. AT THE MIH THERE WAS -- AT THE NIH THERE WAS A MEETING OF THE MEDICAL BOARD AND THEY DID CONCUR WITH THE PRACTICE THAT HAD ALREADY BEEN UNDERWAY BUT IT GETS BACK TO WHAT DR. WILSON WAS SAYING A SECOND AGO, THERE ARE EXTERNAL RESTRICTIONS ON WHAT PEOPLE LICENSED TO PRACTICE MEDICINE CAN DO AND OFTEN TIMES THEY ARE WORRIED ABOUT THEIR OWN LIABILITY. SHOULD THEY GO BEYOND THE NARROW LIMITS THAT ARE IN PLACE AT THE TIME.

I THINK PEOPLE -- AS A PRACTICING PHYSICIAN, I THINK PEOPLE ARE A LITTLE BIT OVERCONFIDENT IN THE TESTS THAT ARE USED FOR DIAGNOSIS AND TREATMENT. I MEAN SIMPLE INTERPRETATIONS OF A CHEST X-RAY WHICH A ROUTINELY DONE FOR A LOT OF THINGS IS NOT SO SIM IMAND YOU GET TWO PEOPLE AND HALF THE TIME THEY MAY HAVE A DIFFERENT IN PER PRA EXPECTATION. SOME OF THE TESTS ARE GOOD. SOME OF THE TESTS ARE NOT. MOST OF THE TESTS IF THEY HAVE A SENSITIVITY AND SPES FIESITY OF 80% THEY ARE CONSIDERED OUTSTANDING BUT THERE IS NO PERFECT TEST AND A LOT OF TIMES THERE IS DATE THAT THAT IS NEW AND EVOLVEING THAT LEADS YOU THE CORRECT DIAGNOSIS AND I THINK TO RESTRICT IT TO SAY THAT AN EXAMINATION IS ONLY USEFUL IF IT IS FDA APPROVED I THINK IS INACCURATE AND NOT THE WAY MEDICINE IS PRACTICED IN THE 21st CENTURY.

LET ME CLARIFY WHAT WE ARE TALKING ABOUT. WE ARE TALKING ABOUT MEDICAL SURVEILLANCE. ROUTINE MEDICAL SURVEILLANCE. WE ARE NOT TALKING ABOUT DIAGNOSIS OF AN ILLNESS, TREATMENT OF A PATIENT FOR AN ILLNESS. THAT IS CLEARLY AND I AGREE, YOU ARE ABSOLUTELY CORRECT BUT IAN INSTITUTION WHO IS GOING TO UNDERTAKE A SEROLOGICAL SURVEILLANCE PROGRAM SHOULD NOT BE USING RESEARCH ASSAYS TO DO SO. THEY SHOULD LIMIT THEMSELVES TO TSH THIS IS A STRONG RECOMMENDATION FROM THE NIH LIMIT THEM SSMS TO FDA APPROVED ASSAYS AVAILABLE FOR SURVEILLANCE IF IT IS NOT PART OF A RESEARCH PROTOCOL. VERY DIFFERENT FROM DIAGNOSIS AND TREATMENT OF A PATIENT.

PERHAPS THE LANGUAGE SHOULD BE THAT FOR STRICTLY FOR SEROLOGICAL ASSAYS AND ANYTHING BEYOND THAT SHOULD BE -- THAT ARE NOT ROUTINE THAT SHOULD MAKE IT CLEAR THAT WE ARE TALKING ABOUT RESEARCH. THERE SHOULD BE AN IRB APPROVAL IN ADDITION TO -- ANY ROUTINE TESTING THAT IS NOT FDA APPROVED SHOULD HAVE AN ACCOMPANYING IRB APPROVAL, I GUESS.

AND I LIKE YOUR SUGGESTION BEFORE, DR. SCHMITT MA THE INCIDENT-BASED INVESTIGATION CAN GO BEYOND THAT AND I THINK THAT WE CAN DISTINGUISH THOSE THREE TYPES OF USES OF THE SURVEILLANCE. SHOULD WE MOVE ON THEN TO THE RISK ASSESSMENT TOOLS? WE HAVE INDICATED BEFORE THAT RISK ASSESSMENT IS A DYNAMIC PROCESS AND THAT NEW INFORMATION IS COMING UP VERY, VERY QUICKLY. AND THAT MANY SUGGESTIONS WERE MADE YESTERDAY IN REGARD TO THIS. SOMETIMES AS IN THE CASE OF THE HIGH PATHOGENIC AVIAN INFLUENZA THEIR THERE -- THERE ARE PERMIT PROCESSES THAT REGULATE WHAT IBCs MAY OR MAY NOT WISH TO APPROVE AND IN OTHER CASES THE IBC HAS A GREAT DEAL OF LATITUDE BECAUSE THE THINGS ARE NOT PERMIT DRIVEN, PARTICULARLY IF IT IS NOT A SELECT AGENT WITH SPECIFIC REQUIREMENTS ON IT. AND SUGGESTIONS ARE MADE HERE ABOUT HOW IBCs CAN GAIN INFORMATION IN A RAPID AND UP-TO-DATE MANNER INCLUDING BIOSAFETY LIST SERVE, ABSA AND A SUGGESTION IS MADE HERE ABOUT PROFESSIONAL SCIENTIFIC AND MEDICAL SOCIETIES FOR EXAMPLE LIKE THE AMERICAN SOCIETY FOR VIROLOGY OR THE AMERICAN SOCIETY FOR MICROBIOLOGY. THERE ARE NOT RESOURCES IN THOSE INSTITUTIONS AT PRESENT FOR THIS KIND OF IBC INTERACTION AND I THINK IF UCH WERE CONSIDERED IT WOULD HAVE TO BE ESTABLISHED. THE THING I THINK WILL BE MOST HELPFUL TO DISCUSS BECAUSE I FEEL WE HAVE DISCUSSED ALREADY SOME OF THE IBC COMMUNICATIONS A BIT EARLIER ARE THE USE OF THE TEMPLATES THAT HAVE BEEN PROVIDED HERE TO HELP THE PIs TO DECIDE WHAT THEY NEED TO TELL TO THE IBCs IN TERMS OF THE RING OF SPECIFIC EX--- THE RISK OF SPECIFIC EXPERIMENT. PROTOCOL-DRIVEN RISKS THAT MAY BE UNDER TAKEN IN THE IBCs TO EVALUATE THOSE. SO THE IDEA OF THESE TEMPLATES WAS TO HELP TO FOCUS ON THE INFORMATION THAT IBCs WOULD NEED AND THEY ARE SIMPLY INTENDED AS A WAY OF SUGGESTING POINTS TO CONSIDER.

COWE HAVE A DISCUSSION NOW BASED ON THE USE OF THE TEMPLATES, THE RING ASSESSMENT -- RISK ASSESSMENTTEMPLATES THAT HAVE BEEN PROVIDED?

BEFORE WE DO THAT, CAN I MAKE A SUGGESTION AND IN THAT WE START OFF BY INCLUDING A STATEMENT AT THE VERY BEGINNING OF THIS THAT THE -- THE MAJOR -- THE POINT 5 THAT IS NOT INCLUDED FROM THE GENERAL POINTS, OKAY, BECAUSE JUST THE PROCESS OF WORKING -- JUST WORKING WITH THESE AGENTS THERE IS GOING BE GUIDANCE IN THE BMBL, OKAY, WHICH HASN'T BEEN ESTABLISHED YET. THIS IS THE KIND OF THINK THAT MOST IBCs LOOK FOR WHEN THEY ARE ASSESSING RISK. THEY SEE THAT AND THEN THEY REALLY DON'T NEED TO DO THEIR RISK -- THEY REALLY DON'T DO RISK ASSESSMENT UNTIL THEY START MA MANIPULATING THE SYSTEM, OKAY. THEN PERHAPS IT SHOULD SAY GIVEN -- GIVEN THE -- THE NATURE OF RECOMBINANT DNA NOT EVERY EXPERIMENT CAN BE IMAGINED TO THE PROCESS OF DETERMINING APPROPRIATE CONTAINMENT AND GO ON FROM THERE. AND THESE TEMPLATES ARE MOSTLY GOING TO BE USED, I WOULD IMAGINE, NOT FOR WORKING WITH THE WILD-TYPE VIRUS, BUT RATHER FOR WORKING WITH VIRUSES THAT HAVE BEEN MANIPULATED TO BE LESS PATHOGENIC.

DO YOU ALWAYS KNOW IN ADVANCE THAT THEY WILL BE LESS?

NO, NO, NO, NO, NO. THAT WOULD BE THE INTENT OF THE INVESTIGATOR I WOULD IMAGINE BECAUSE WE HAVE THEARD QUITE OFT -- HEARD THAT QUITE OFTEN TO ATTENUATE VIRUSES. REDUCES THE PATHOGENICITY BUT NO, THAT IS PART OF THE ASSESSMENT. IF THEY CLONE -- IF THEY CLONE SOMETHING IN TO THESE -- A DIFFERENT GENE INTO THESE VIRUSES, FOR CAM EXAMPLE, AN EX-ONLY US IN GENE WHICH I'M SURE PEOPLE WILL START TO DO THAT THEN YOU HAVE TO CONSIDER THE ACTIVITY OF THAT GENE AND THAT WOULD BE PART OF THE RISK ASSESSMENT.

I THOUGHT PERHAPS TO FOLLOW UP ON OUR RATHER ANIMATED DISCUSSION YESTERDAY EVENING OF THE HYPOTHETICAL TABLE PERHAPS IN ORDER TO CAPTURE THE THOUGHT PROCESS THAT WENT INTO -- INTO P. DEVELOPING THAT TABLE WITHOUT INCLUDING THE BIOSAFETY LEVELS WE COULD ENCLOSE A LIST OF POINTS TO CONSIDER FOR RING ASSESSMENT FOR MAKING RECOMBINANT OR REASSORTMENT INFLUENZA VIRUSES THAT WOULD HAVE POINTS THAT THE RESEARCHER COULD ADDRESS THAT WOULD PROVIDE INFORMATION FOR THE IBC TO ASSESS. I MEAN ALL THE IBCs KNOW THAT YOU ARE SUPPOSED TO DO A RISK ASSESSMENT BUT WE NEED SOME INFORMATION ON SPECIFIC POINTS THAT ARE RELEVANT AND SO WE COULD INCLUDE POINTS SUCH AS THE PRESENCE OF HIGH PATH AVIAN INFLUENZA OR THE PRESENCE OF THE 1918 STRAIN OR ASK WHETHER THE HEMOBLUET HEMOGLIEWT THEN HEMOGLUE CONTINUE HAS THE. IN THE CONSTRUCT CARRIES THE SURFACE GENES IN FROM THE HIGH PATH AVIAN INFLUENZA PARENT. IS THE REASSORTANT HIGHLY PATHOGENIC FOR CHICKENS OR IN OTHER TEST ANIMALS OR ARE THE REASSORTANTS LIKELY TO BE SENSITIVE OR KNOWN TO BE SENSITIVE TO ANTIVIRALS AND THAT WOULD PROVIDE AT LEAST A LITTLE -- THOUGH IT IS VERY SPECIFIC -- FOR INFLUENZA, IT WOULD PROVIDE INFORMATION THAT THE IBCs COULD USE. IT WOULD PROVIDE A TOOL THE IBCs COULD USE TO GET THE INFORMATION TO DO A RISK ASSESSMENT.

A SPECIFIC LIST IN LIEU OF THE TEMPLATE?

IT WOULD BE IN ADDITION TO THE TEMPLATE, THAT THAT INFORMATION WOULD HELP.

BECAUSE I BELIEVE AT LEAST THE -- AS YOU POINTED OUT, I GUESS, THE TEMPLATE DOESN'T REALLY ASK FOR THE REASSORTANTS OR THE RESULT OF MIXING AND MATCHING.

I'D LIKE TO HEAR FROM THE FLU PEOPLE ABOUT THAT.

RIGHT.

JUST --

WHAT I SUGGEST THE ARE JUST A FEW OF THE POINTS IT WOULD HAVE TO BE MORE HIGHLY DEVELOPED BY THE EXPERT INFLUENZA RESEARCHERS. THEY COULD ADD A LOT MORE TO IT.

THAT BRINGS AN IMPORTANT POINT TO ME THAT IT WOULD BE NICE TO HAVE A PLACE WHERE IBCs COULD LEARN WHAT IS ARE THE RELEVANT FACTORS FOR PATHOGENICITY FOR INFLUENZA FOR EXAMPLE A WEBSITE AND EXPERT RECOMMENDATION THAT IS WHAT THE TEM PLATE CONCEPT WAS. COMMENTS FROM THE FLU PEOPLE ON THAT?

NO.

WE AT LEAST IN MY PROTOCOL WE DO THOSE THINGS GO THROUGH THOSE POINTS ANYWAY TO PROVIDE INFORMATION TO IBC MEMBERS. SO BUT SINCE WE APPEAR TO PROVIDE GUIDANCE FOR THE PEOPLE WHO DON'T DO IT IT MAY BE A GOOD IDEA TO HAVE THOSE FINALLY N THIS TABLE. BUT I DON'T KNOW HOW FAR WE CAN DO, YOU KNOW, ALL THOSE POINTS. WE CAN THINK OF MANY DIFFERENT THINGS. SO, IT -- THE ONE THAT WE HAVE IS SORT OF GENERAL SO IT IS THAT HOW FAR SPECIFIC POINTS WE WILL GO FOR. SO THAT IS -- WE NEED TO DISCUSS MORE.

I JUST THINK WITH THAT KIND OF EXAMPLE WE ARE TALKING ABOUT A VERY LIMITED SET OF EXPERIMENTS AND A LIMITED AND VERY -- THE REASSORTANTS FOR EXAMPLE, CAN BE DONE WITHOUT THE USE OF RECOMBINANT DNA. SO WE ARE REALLY ONLY TAKING CARE OF PEOPLE WHO ARE GOING TO MAKE REASSORTANTS BY REVERSE GENETICS AND THERE ARE SO MANY MORE EXAMPLES THAT WE COULDN'T POSSIBLY -- WE COULD BE HERE ALL DAY LISTING THE POSSIBLE THINGS YOU CAN WITH RECOMBINANT DNA WITH REVERSE GENETICS WITH FLU AND I DON'T KNOW HOW THAT SPECIFIC EXAMPLE OF REASSORTANTS IS GOING TO BE GENERALLY HELPFUL TO IBCs IN REVIEWING FLU RESEARCH WHEN THIS FACT THEY DON'T EVEN NEED TO -- THEY DON'T EVEN NEED TO CONSIDER RECOMBINANT DNA WHEN THEY ARE TALKING ABOUT REASSORTANTS.

I THINK THAT PROCESS SHOULD BE MORE OR LESS UP TO THEM. THERE IS -- THERE ARE PLACES WHERE THEY CAN GO AND THIS IS THE IMPORTANT THING THAT WE KEEP COMING BACK TO, TO -- TO GAIN INFORMATION FROM THE BIOLOGY OF THE SYSTEM. THE GENERAL RISK ASSESSMENT THERE ARE -- THERE IS A TABLE HERE. A GENERAL TABLE. AND ONE THAT CAME OUT, THIS IS EVEN IN THE NIH GUIDELINES I THINK PERHAPS WE SHOULD POINT THEM TO THAT SECTION IN THE NIH GUIDELINES BECAUSE UNTIL NOW I DON'T THINK IBCs HAVE HAD THE NEED TO REALLY GO THAT DEEP INTO THE NIH GUIDELINES AND DO RISK ASSESSMENT SO THIS STUFF REALLY IS THERE AND THEY NEED TO BE AWARE IT IS THERE AND THAT IT IS THEIR RESPONSIBILITY NOW TO TAKE THESE THINGS INTO CONSIDERATION AND OBTAIN THE INFORMATION ABOUT THE BIOLOGY OF THESE PARTICULAR AGENTS THAT APPLY TO THAT RISK ASSESSMENT.

ARE YOU TALKING NOW ABOUT THAT RISK ASSESSMENT TEMPLATE WITH AGENT FACTORS ON IT, ET CETERA? I THOUGHT ONE OF THE THINGS WE DISCUSSED YESTERDAY WAS MAYBE ADDING AN ECONOMIC CATEGORY TO THAT SO I JUST WANTED TO MAKE SURE THAT IF YOU ARE SORT OF -- I'M NOT TALKING ABOUT ANY DOCUMENT THAT IS SPECIFIC --

I THOUGHT YOU WERE TALKING ABOUT THE NIH GUIDELINES FOR RESEARCH.

IT SAYS NIH GUIDELINES RESEARCH RISK ASSESSMENT TEM PLATE. I THOUGHT YESTERDAYS IT CONVERSATION ONE OF THE POINTS THAT WE WANTED TO INCLUDE ON THAT WAS THE POSSIBLE ECONOMIC IMPACT THAT A PARTICULAR EXPERIMENT MIGHT HAVE. JUST AS ANOTHER CATEGORY WHERE YOU HAVE AGENT FACTORS GENE MODIFICATION, MANIPULATION, MIGHT HAVE A LITTLE LINE GOING ACROSS CALLED ECONOMIC IMPACT AND CONSIDERATIONS.

ALL RIGHT. IN -- AND POSSIBLY THESE -- THIS WAS OBVIOUSLY MADE BEFORE SELECT AGENTS. SELECT AGENTS ARE ALSO ANOTHER ISSUE.

I JUST WANTED TO CLARIFY, I THINK A POINT YOU JUST MADE ABOUT WHETHER IBCs SHOULD BE EXPECTED TO CONSIDER REASSORTMENT. THE DISCUSSION -- THERE WAS A DISCUSSION YESTERDAY BY DOCTOR DR. WILSON THAT HERE AT NIH THEY CONSIDER BOTH. AND I JUST WANTED TO BE CLEAR I WAS PT CLEAR IF YOU WERE -- I WASN'T CLEAR IF YOU WERE SUGGESTING THAT REACCOURTMENTS WERE NOT THE DOMAIN -- REASSORTMENTS WERE NOT THE DOMAIN OF THE IBC?

THIS IS ANOTHER DISCUSSION THAT WE HAVE HAD. IBCs ARE DIFFERENT IN DIFFERENT PLACES. SOME PLACES HAVE TWO COMMITTEES, BIOHAZARD COMMITTEE AND A COMMITTEE THAT JUST DEALS WITH THE NILE GUIDELINES. THE NIH GUIDELINES DOESN'T DEAL WITH FLU REASSORTMENTS MADE BY JUST CROSSING THE TWO VIRUSES BUT IT DOES USE THE -- OR THE USE OF REVERSE GENETICS TO DO THAT. THAT EXAMPLE WAS JUST A -- YOU KNOW, JUST THE TIP OF THE ICEBERG OF WHAT YOU CAN DO WITH -- WITH RECOMBINANT DNA AND INFLUENZA AND THAT SPECIFIC EXAMPLE COULD -- DOESN'T EVEN COME -- MAY NOT EVEN COME UNDER THE PURVIEW OF THE NIH GUIDELINES. G IT'S DONE BY -- IF IT'S DONE BY JUST CROSSING.

MAY I USE YOUR COMMITTEE FOR A MOMENT? LET ME POSE A QUESTION THEN IF THAT IS AN ISSUE AND THERE SEEMS TO BE AS I IDENTIFIED YESTERDAY, A GAP IN THE BMBL WILL TRY TO HELP FILL THAT GAP BETWEEN RECOMBINANT DNA AND THEN MORE NATURALLY OCCURRING KINDS OF RECOMBINATION LIKE REASSORTANTS. WOULD IT BE USEFUL TO THE USER COMMUNITY FOR THE BMBL TO ADDRESS THE CONSTITUTION OF BUYEE SAFETY COMMITTEES AND THE KINDS OF THINGS THAT MAY BE EXPECTED BY A BIOSAFETY COMMITTEE ABOVE AND BEYOND THAT DESCRIBED IN THE RECOMBINANT DNA GUIDELINES. PLEASE STAND BY FOR CHANGE OF CAPTIONERS.

BECAUSE MANY INSTITUTIONS DO CONSIDER ONLY THINGS THAT HAVE RECOMBINANT DNA IN THEIR LINEAGE.

SO, SO YOU COULD SAY THAT AND THEN SAY SOMEHOW THE INSTITUTION IS RESPONSIBLE FOR BOTH.

I THINK WHILE PROVIDING LATITUDE FOR THE INSTITUTIONS, I THINK SOME INSTITUTIONS MAY NOT HAVE EVEN THOUGHT ABOUT THE FACT THAT IT COULD BE A COMBINED COMMITTEE OR AS KATE SAID, THAT THEY HAVE A RESPONSIBILITIES IN THAT OTHER DOMAIN AS WELL. SO, SOMETIMES IT'S JUST RAISING THE AWARENESS AND SAYING OH, AND, BY THE WAY, YOU COULD PERHAPS SAVE YOURSELF SOME TIME AND TROUBLE AND BE MORE EFFICIENT -- EFISHIENT IF YOU USE SOME OF THE SAME PEOPLE TO DO THIS.

ONE OF THE -- JUST TO SHARE WITH YOU, IF I MAY, A TECHNICAL APPROACH THAT WE FOUND BECAUSE WE WERE SUCH A HUGE INSTITUTION HERE IN THE PROGRAM, YOU KNOW, THOUSANDS AND THOUSANDS OF LABORATORIES AND MANY, MANY MORE INFECTIOUS DISEASE PROTOCOLS, WE HAVE A POLICY THAT EACH AND EVERY ONE OF THOSE PROTOCOLS AND THE REGISTRATION OF EVERY PATHO -- PATHOGEN MUST BE REVIEWED BY THE INSTITUTIONAL BIOSAFETY COMMITTEE. THAT'S ALL FINE AND GOOD BUT IT QUICKLY MEANS THE COMMITTEE BETTER BE MEETING EVERY DAY TO KEEP UP WITH THE WORKLOAD. IT WAS VERY CLEAR THAT WAS NOT GOING TO WORK. THE IBC ESTABLISHED A POLICY FOR REVIEW ANDY THAT ARE THE ULTIMATE -- AND THEY ARE THE ULTIMATE SPOL 40, IF YOU WILL, USING THE TERM LOOSE LIE -- LOOSELY AT NIH, BUT THEN THEY DELL GATED THAT AUTHORITY TO THE BIOSAFETY OFFICE FOR THE MORE TYPICAL REVIEW OF THE HUMAN PATHOGENS AND DOING THOSE KEENS OF RISK ASSESSMENTS BUT THERE IS A CLEAR CHAIN OF AUTHORITY THAT IS DESIGNATED WITHIN THE NIH. AND SO WE HAVE MANAGED TO WORK WITHIN THE IBC STRUCTURE BUT SUPPLEMENT AND REDELEGATE CERTAIN AUTHORITIES BUT CLEARLY MAKE SURE THAT THE INSTITUTION IS, INDEED, DOING THIS IN A BROADER SENSE BEYOND THE GUIDELINES. JUST, YOU KNOW, AS ONE MODEL FOR DOING IT .

HAVE ANY OTHER COMMENTS?

I WOULD LIKE TO EMPHASIZE ONE OF THE RISK ASSESSMENT TOOLS OR THE STATEMENT, I THINK IT'S IMPORTANT THAT THE PIs ALSO MAINTAIN THEIR RESPONSIBILITY TO REPORT TO THE IBC ON ANY OCCURRENCE OF UNEXPECTED RESULT THAT WOULD ALTER THEIR RISK CHARACTERISTICS OF THE PARTICULAR PROTOCOL, WHETHER IT'S UP OR DOWN AND IT JUST, THE RISK ASSESSMENT IS A CONTINUING PROCESS AND IF, IN FACT, THEY FIND A RESULT OF, THAT ALTERS THE RISK OR WAS UNEXPECTED THAT MAY HAVE A RISK INFLUENCE, IT SHOULD BE BROUGHT TO THE ATTENTION OF THE IBC.

PROMPTLY.

PROMPTLY.

I THINK THAT'S A GOOD EDITION. AND WE HAVE GUIDELINES HERE. WE HAVE SOME GUIDELINES HERE THAT WERE DEALT IN PREPARING THE BMBL, I THINK, FOR HIGH-PATH INFLUENZA, AND WE TRIED TO MAKE A SIMILAR DOCUMENT FOR DEALING WITH SARS, WHICH IS A VIRUS THAT, THAT'S BEING STUDIED IN MANY LABS AND THE RISKS ARE, ARE BEING DECIDE IN EACH INSTITUTION AND RECOMMENDED BY EACH DIFFERENT PE. THERE IS NO UNIFORMITY -- PI. THERE IS NO UNIFORMITY EXCEPT AS INFORMALLY PEOPLE WHO HAVE DONE A CAREFUL JOB HAVE GENEROUSLY SHARED THEIR PROTOCOLS FROM PEOPLE FROM OTHER INSTITUTIONS AND THEN THAT KIND OF IBC INTERACTION THAT WE HAVE JUST DISCUSSED HAS BEEN IN FACT GOING ON AN INFORMAL BASIS WITH SARS, BUT NOT IN THE ORGANIZED WAY. WE FOUND THAT IN MAKING UP THIS EXAMPLE RISK ASSESSMENT TEMPLATE, NOT ALL EXPERTS AGREE, AND THAT, SO THIS IS REALLY NOT INTENDED TO BE GUIDANCE FOR IBCs. IT WAS REALLY AN EXERCISE IN SEEING HOW WE COULD WORK IT OUT. I WOULD NOT LIKE IT TO GO FORWARD AS RECOMMENDED GUIDANCE THAT IS STILL IN THE DRAFT FORM. BUT I WOULD BE INTERESTED IN COMMENTS ON WHETHER SUCH A DOCUMENT IS WORTH BEING CONTINUELY JUST UP, YOU KNOW, FURTHER DISCUSSED BY EXPERTS IN THE SARS FIELD SO THAT SOMETHING LIKE THAT MIGHT BE PROVIDED ON A WEB SITE THROUGH THE -- [ INDISCERNIBLE ] TWO OTHER IBCs. IS THERE MERIT IN THIS OR A DIFFERENT FORM AT THAT MIGHT BE HELPFUL? IS THE EXTRA OPINION NEEDED? HOW, HOW WITH A NEW AGENT WOULD IT BE MOST HELPFUL TO IBCs TO PROCEED IN ORDER TO ALLOW THE IMPORTANT RESEARCH TO BE DONE THAT WILL GET US TO DRUGS AND VACCINES AND UNDERSTANDING THE APPROPRIATENESS OF SAFETY .

YEAH, I THINK SO, TOO. I THINK IT'S DIFFICULT PROBLEM WHEN THERE IS A NEW AND EMERGING ORGANISM AND WE DON'T KNOW TOO MUCH ABOUT IT, BUT I THINK WE NEED TO SHARE AS MUCH AS POSSIBLE WITH EXPERIENCE FROM LABORATORIES THAT HAVE GOT GOOD APPROVED PROTOCOL, AND I THINK THAT'S PERHAPS THE FIRST IMPORTANT THING. DO YOU HAVE A COMMENT?

BRUCE FROM THE AIDS CAMPAIGN NATIONAL INSTITUTE IN FREDERICK. I WAS NOTICING THE CORONA VIRUS MEAT REX, THERE WAS A LOT TO -- MATRIX, THERE WAS A LOT TO DRAW ON PREVIOUS VIRUSES FROM THE HISTORY OF STRAND VIRUSES THAT HAVE BEEN LONG USED SINCE STRIKING OUT YELLOW, CLONE THE FIRST POLIO VIRUS. IT WOULD BE INTERESTING TAKING THAT HISTORY OF THE STRAND RNA VIRUSES INTO CONSIDERATION, AS WELL AS OTHER INFECTIOUS VIRUSES SUCH AS PROVIRUSES FROM MURINE SYMPTOMS TO LETHAL HUMAN RETROVIRUSES. WHAT IS THE HISTORY OF INFECTION USE THOSE DNAs AS INFECTIOUS DNAs FOR PEOPLE WORKING IN THE LABORATORY. THERE WAS SOME DISCUSSION YESTERDAY ABOUT INCREASING THE AMOUNT OF BIOSAFETY REGULATIONS WHEN MANIPULATING THE DNAs. I THINK THERE HAS BEEN A LONG HISTORY OF PEOPLE MANIPULATING PROVIRAL DNA AND INFECTIOUS DNA CAUSING THE STRAND RNA VIRUSES THAT WOULD PROVE THOSE ARE RELATIVELY BENIGN UNLESS THERE WAS A SHARP EXPOSURE. WAS THERE ANY -- I HAD TO LEAVE EARLY TO PARTICIPATE IN THE DISCUSSION, BUT A LARGE PORTION OF THE MATRIX DEALING WITH THE SARS SEEMS TO BE CONSIDERING THINGS AND THAT MAY NOT BE AS RELEVANT BY DRAWING ON OTHER EXPERIENCES FROM OTHER VIRUSES.

Reporter: THINK YOU'RE TALKING ABOUT A SPECIFIC EXAMPLE OF HOW TO DEAL WITH CLONES AND INFECTIOUS CLONES. THAT WOULD BE THE ONLY, I THINK, MOST WOULD AGREE THAT WOULD BE THE ONLY RISK IN DEALING WITH INFECTIOUS CLONES AND THAT WOULD BE THE SHARP EXPOSURES, WHICH IS SOMETHING THAT PEOPLE NEED TO KNOW ABOUT, ALL RIGHT, SO WHEN PEOPLE DO OFF THEN -- .

THAT'S NOT NECESSARILY TRUE. CAN YOU GET INFECTED WITH DNAs OF -- OF ORGANISMS, SOME OF THE EARLY RISK ASSESSMENTS WERE DONE WITH THE POLYOMA GIVEN AS A DNA EARLY AND THAT INITIATED INFECT. I MEAN VERY POORLY INFECTIONS AND IT'S -- YOU SHOULD NOT MAKE THE ASSUMPTION THAT THE ONLY ROUTE YOU CAN BE INFECTED WITH BY DNA IS, IS A BIPERENNIAL ROUTE.

RIGHT. THAT IS A MAJOR. THAT'S THE MAJOR PROBLEM --

ABSOLUTELY. GREATER INFECTIVITY BY THAT ROUTE. VERY LOW BY THE OTHER ROUTE BUT NOT NO INFECTIVITY.

THE ISSUE HERE IS PEOPLE WHEN THEY DO MANIPULATE RECOMBINANT DNA, THEY'RE USING POINT GRADIENTS AND USING SHARPS AND THAT HAS TO, THEY HAVE TO BE AWARE OF THAT WHEN DEALING WITH INFECTIOUS CLONE.

I JUST WANTED TO MAKE A STATEMENTY THAT I THINK WHAT KAY AND I WANTED TO IMPART WAS THAT COMPARED TO FLU, WHICH GENERALLY HAS ONE GENETIC SYSTEM, CORONA VIRUS, WHICH HAS ALL SYSTEMS, THE COMMITTEE SHOULD CONSIDER THAT IN THEIR EVALUATION. OTHERWISE, I AGREE WITH THE STATEMENTS MADE ABOUT THE SAFETY ISSUE .

GO AHEAD.

BEFORE WE LEAVE -- [ INDISCERNIBLE ] LET'S MOVE ON. I APOLOGIZE FOR NOT BEING HERE YESTERDAY. IF THIS WAS COVERED, YOU CAN STOP ME. THERE ARE A LOT OF PARALLELS BETWEEN IOCOKES AND IBCs. IOCOKES HAVE REGULATIONS AND RULES AS FAR AS CONSTITUTION OF MEMBERS SO THERE IS REPRESENTATION FROM VARIOUS DIFFERENT BACKGROUNDS AND THE OTHER THING REQUIRE SIDE TRAINING. RELATED BACK TO THE FIRST ISSUE WE TALKED ABOUT ON TRAINING, WE TALKED ABOUT TRAPPING IN THE PIs AND PEOPLE DOING EXPERIMENTS. I WONDER IF THERE HAS TO BE TRAINING FOR IBC MEMBERS AS WELL. AND THAT MEET RELATE SPECIFICALLY ON RISK ASSESSMENT. RISK ASSESSMENT AS IT CAN BE DONE, GUT FEELINGWISE, BUT THERE IS A REAL SCIENCE BEHIND IT. CAN YOU BE TRAINED ON HOW TO DO A RIDICULOUS ASSESSMENT TO PUT PROCESS BEHIND THAT. THAT'S WHAT WE'RE TACKING ABOUT HERE. IT MAY EXTEND THAT TO OTHER THINGS IF YOU WANT TO THINK ABOUT TRAINING OF IBC MEMBERS IN OTHERIARIES WITH THE BACKGROUND AND EXPERTISE. ALSO, THE CONSTITUTION OF THE IBC. I KNOW THAT'S GETTING MORE INTO THE PROCESS, BUT I JUST THROW THAT OUT AS A THOUGHT. MAYBE WE HAVE MORE STRUCTURE BEHIND THAT.

DOES THAT FALL INTO THE CATEGORY WHERE WE HAD, IN THE PREPARATION TELECONFERENCE BEAT UP THESE AND MARINA ABOUT THE TRAINING COMPONENT AND WE WERE PROMISED THAT THIS IS THE FIRST OF THE MEETINGS. AND TRAINING AS WELL AS ALSO I THINK EDUCATION OF THE PUBLIC AND BEING ABLE TO DISCUSS THIS IN A MANNER THAT THE PUBLIC CAN ALSO COMPREHEND. THOSE ARE TWO THINGS THAT WE'RE JUST -- WERE JUST CONSIDERED TOO LARGE TO JAM INTO THIS ONE MEETING, BUT THAT'S NOT GOING TO BE LEST TO DIE.

NO. AS, AS DR. PATTERSON POINTED OUT IN HER OPENING REMARKS IN THIS PART OF THE GENERAL COMMENT, OBA HAS AND WILL CONTINUE TO PROVIDE EDUCATIONAL PROGRAMS AND ASSISTANCE TO IBCs. CERTAINLY THAT IS ONIARY THAT WE ARE WELL-AWARE OF THAT NEEDS TO BE TAKEN CARE OF, AND WE'LL BE WORKING TOWARD MEETING THAT, THAT NEED IN THE FUTURE AND WORKING WITH ABSA AND GETTING INFORMATION ON WHO CAN PROVIDE THAT TYPE OF TRAINING FOR EBC MEMBERS GOING FORWARD . I THINK WE HAVE COVERED A LARGE AMOUNT OF TERRITORY, A LARGE NUMBER OF ISSUES. AS IT SAYS, THIS IS A BEGINNING OF THE DEVELOPMENT OF THE POINTS TO CONSIDER AND BETWEEN NOW AND THE NEXT RAC MEETING, WE WILL BE COMING BACK WITH REFINEMENT OF THE DOCUMENT TO THE PANEL MEMBERS FOR THEIR INPUT AND THEN AT THE DECEMBER RAC MEETING, WE ENVISION PRESENTING THE POINTS TO CONSIDER FOR PUBLIC COMMENT AND AND RAC COMMENTS AND ENDORSEMENT AS A FORMAL SET OF POINTS TO CONSIDER TO GO FORWARD FOR THE COMMUNITY. ARE THERE ANY OTHER COMMENTS FROM THE PANEL MEMBERS, THINGS THAT THEY WISH TO SAY AS PART OF THEIR CLOSING REMARKS WITH RESPECT TO THIS? I THINK WITH THAT WE THANK YOU ALL. WE'RE EARLY AND ADJOURN