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THOMPSON: HELLO, I'M TOMMY THOMPSON, THE SECRETARY OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES. IT'S MY GREAT PLEASURE TO WELCOME YOU TO THIS MEETING. OUR ROLE HERE TODAY IS TO UNDERSCORE MY PERSONAL COMMITMENT AND THE COMMITMENT OF THIS ADMINISTRATION TO THE DEVELOPMENT OF THE NEW REGULATIONS INTENDED TO PROTECT THE UNITED STATES' FOOD SUPPLY. IN THE DAYS AND WEEKS AFTER SEPTEMBER 11th AND STILL TODAY, AMERICANS OFTEN ASK ME WHERE AMERICA IS AT RISK THE MOST FROM TERRORISTS. I THOUGHT LONG AND HARD ABOUT THE ANSWER. THE MORE I THOUGHT ABOUT IT, THE MORE I REALIZED THAT ONE OF OUR GREATEST POTENTIAL VULNERABILITIES IS OUR FOOD SUPPLY. IN THE WAKE OF THE TERRORIST ATTACKS ON OUR COUNTRY, IT WAS CLEAR THAT WE NEEDED TO DO MORE TO PROTECT THE FOOD SUPPLY, AND WE HAVE. THE U.S. FOOD SUPPLY IS SAFE AND EVERY DAY IT BECOMES SAFER AND MORE SECURE. I VIGOROUSLY SUPPORTED OBTAINING ADDITIONAL RESOURCES FOR THE UNITED STATES FOOD & DRUG ADMINISTRATION IN ORDER TO DEAL WITH THE TERRORIST THREAT, AND IN 2002, THANKS TO CONGRESS AND THE PRESIDENT, THE FDA RECEIVED APPROXIMATELY $150^MILLION IN THE EMERGENCY SUPPLEMENT TO DEAL WITH TERRORISM. WITH THAT MONEY, THE FDA WAS ABLE TO HIRE MORE THAN 800^NEW EMPLOYEES FOR COUNTERTERRORISM WORK. APPROXIMATELY 650^OF THOSE NEW EMPLOYEES NOW WORK ON THE FRONT LINES OF THE BATTLE IN ORDER TO IMPROVE FOOD SECURITY AND FOOD SAFETY. I THANK YOU FOR PARTICIPATING IN THIS PUBLIC MEETING, AND I APPRECIATE THE CONTINUED INPUT FROM OUR DOMESTIC INDUSTRY, OUR CONSUMERS, AND OUR TRADING PARTNERS, AS WE IMPLEMENT THESE NEW RULES. THIS ADMINISTRATION IS RESOLUTE IN OUR COMMITMENT TO PROTECTING OUR FOOD SUPPLY, AND I LOOK FORWARD TO CONTINUING TO WORK WITH YOU TO ENSURE THIS GOAL IS ACHIEVED. GOD BLESS YOU, AND GOD BLESS THE UNITED STATES OF AMERICA. \M\M
WELCOME TO THIS LIVE VIDEO TELECONFERENCE. I'M MARK BARNETT OF THE U.S. FOOD AND DRUG ADMINISTRATION, AND I'LL BE SERVING AS YOUR MODERATOR THIS AFTERNOON. TODAY WE'RE GOING TO TALK ABOUT TWO IMPORTANT REGULATIONS THAT WILL HELP PROTECT OUR NATION AGAINST BIOTERRORISM AND OTHER RELATED EMERGENCIES. THESE TWO REGULATIONS WILL EXPAND FDA'S ABILITY TO ADDRESS CONTAMINATION FROM BIOTERRORISM AND FROM ANY OTHER FORM OF CONTAMINATION OF THE FOOD SUPPLY, WHETHER INTENTIONAL OR ACCIDENTAL. BOTH OF THE REGULATIONS APPLY TO FOOD AND FEED THAT'S REGULATED BY THE FDA. ONE REGULATION REQUIRES THE REGISTRATION OF FOOD AND FEED FACILITIES, AND THE OTHER REGULATION REQUIRES PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS. OUR SHOW TODAY IS BEING BROADCAST LIVE THROUGHOUT THE UNITED STATES, IN CANADA, MEXICO, THE CARIBBEAN AND THROUGHOUT SOUTH AMERICA. OUR BROADCAST AUDIENCE INCLUDES MANUFACTURERS, PROCESSORS, DISTRIBUTORS AND TRANSPORTERS OF FOOD AND ANIMAL FEEDS. IN ADDITION, THERE ARE IMPORTERS, AGENTS, BROKERS AND REPRESENTATIVES FROM VARIOUS EMBASSIES THROUGHOUT THE WORLD THAT ARE TUNED IN TO THIS BROADCAST. WE HAVE TWO BASIC GOALS TODAY^-- FIRST, WE WANT TO BE SURE THAT YOU UNDERSTAND THESE REGULATIONS^-- WHY THEY WERE DEVELOPED, WHAT THEY PROVIDE FOR AND WHAT YOU MUST DO TO COMPLY WITH THEM. SO IN A WAY, THIS BROADCAST WILL HELP TO GET YOU READY FOR NEW REQUIREMENTS THAT ARE BEING MANDATED BY U.S. LAW AND WHICH BECOME EFFECTIVE ON DECEMBER 12th. FOR THOSE OF YOU WHO MAY NOT BE FAMILIAR WITH OUR RULEMAKING PROCESS, LET ME EXPLAIN A LITTLE BIT ABOUT HOW IT WORKS. OUR "NOTICE AND COMMENT" FORM OF RULEMAKING REQUIRES THAT PROPOSED REGULATIONS BE PUBLISHED IN A DOCUMENT CALLED THE FEDERAL REGISTER. THIS PROVIDES A NOTICE OF WHAT A GOVERNMENT AGENCY IS CONSIDERING IN A PARTICULAR REGULATION, AND IT ALLOWS INTERESTED PARTIES TO SUBMIT COMMENTS OR SUGGESTIONS TO MAKE THE PROPOSED REGULATION MORE EFFECTIVE OR LESS BURDENSOME. COMMENTS ON A PROPOSED REGULATION ARE ACCEPTED FOR A SPECIFIED PERIOD OF TIME. THEY'RE CAREFULLY CONSIDERED BY THE GOVERNMENT AGENCY PROPOSING THE REGULATION, AND LATER THEY'RE SUMMARIZED AND DISCUSSED IN THE PREAMBLE SECTION OF THE FINAL RULE. IN THE CASE OF THESE TWO REGULATIONS ON REGISTRATION AND PRIOR NOTICE, MANY OF YOU SENT IN COMMENTS TO THE PROPOSED RULES, AND THOSE COMMENTS HELPED SHAPE THEM IN THEIR PRESENT FORM. AT THIS POINT, WE HAVE ISSUED THESE RULES AS INTERIM FINAL REGULATIONS. AND TO DISCUSS WHAT THAT MEANS, LET'S BRIEFLY TURN TO A CONVERSATION I HAD EARLIER WITH THE COMMISSIONER OF THE U.S. FOOD AND DRUG ADMINISTRATION, DR.^MARK McCLELLAN. DR.^McCLELLAN, WHAT WAS THE BASIC REASON FOR THESE NEW REGULATIONS?
McCLELLAN: OUR GOAL IS TO KEEP OUR FOOD SUPPLY SAFE AND SECURE WITHOUT INHIBITING TRADE. TODAY ON THE ONE HAND, WE'VE GOT MORE OPPORTUNITIES FOR AMERICANS TO HAVE GOOD WHOLESOME, TASTY HIGH VARIETIES OF FOODS THAN EVER BEFORE, A LOT OF IT BECAUSE OF THE IMPORTS COMING INTO THIS COUNTRY. WHICH MAKE UP A LARGE PART OF OUR FOOD SUPPLY. ON THE OTHER HAND, WE'RE FACING SOME NEW THREATS, NOT ONLY PROBLEMS THAT CAN GO WRONG WITH FOODS, BUT DELIBERATE ATTEMPTS TO CONTAMINATE OUR FOOD SUPPLY, AND WE NEED TO TAKE NEW STEPS TO BE READY FOR THAT. OUR REGULATIONS WILL GIVE US AN UNPRECEDENTED ABILITY TO MONITOR THE FOODS COMING INTO THIS COUNTRY TO HELP MAKE SURE THEY'RE SAFE AND SECURE AND TAKE ACTION EFFECTIVELY IF THERE IS A PROBLEM.
IT MAY TAKE SOME TIME THOUGH FOR THE PEOPLE WHO ARE GOING TO BE AFFECTED BY THIS REGULATION TO MAKE THE CHANGES THAT THEY'RE GOING TO NEED TO MAKE IN ORDER TO COMPLY. ARE YOU ANTICIPATING SOME FLEXIBILITY IN ENFORCING THIS, AT LEAST IN THE BEGINNING?
McCLELLAN: WE CERTAINLY ARE. FOR THE FIRST FOUR MONTHS AFTER THE RULES GO INTO EFFECT, WE WILL BE FOCUSING OUR EFFORTS ON EDUCATION, ON HELPING PEOPLE COMPLY WITH THE NEW REQUIREMENTS. AND OVER TIME, WE'LL BE PHASING IN THE FULL ENFORCEMENT OF THE RULES.
I NOTICE THAT THEY'RE CALLED "INTERIM FINAL RULES." WHAT DOES THAT MEAN? THAT'S KIND OF UNUSUAL ISN'T IT?
McCLELLAN: IT IS BUT IT IS IMPORTANT IN THIS CASE. INTERIM FINAL MEANS THAT WE'RE TAKING FURTHER COMMENTS ON THE RULES. SO EVEN THOUGH THEY'RE KIND OF FINAL REGULATIONS, AND EVEN THOUGH THEY ARE GOING TO GO INTO EFFECT ON DECEMBER 12th, WE HAVE A 75-DAY COMMENT PERIOD OPEN NOW FOR FURTHER OPPORTUNITIES TO HELP US MAKE SURE THAT THESE REGULATIONS WORK AS EFFECTIVELY AS POSSIBLE.
BUT LET ME MAKE SURE I UNDERSTAND. EVEN THOUGH YOU'RE STILL ACCEPTING COMMENTS ON THE REGULATION, THEY DO HAVE THE FORCE OF LAW ON DECEMBER THE 12th AS THEY GO INTO EFFECT?
McCLELLAN: YES.
OKAY. WHAT'S THE MOST IMPORTANT MESSAGE THAT YOU WOULD LEAVE WITH THE FOLKS THAT ARE WATCHING THIS BROADCAST ABOUT THESE NEW RULES?
McCLELLAN: THE IMPORTANT MESSAGE IS THAT WE ARE ALL IN THIS TOGETHER, TO KEEP OUR FOOD SUPPLY SECURE IN THE UNITED STATES, AND TO GIVE AMERICANS CONFIDENCE THAT THE FOOD THAT THEY ARE EATING ARE SAFE AND SECURE. WE'VE LEARNED A LOT FROM THE PROCESS OF DEVELOPING THESE REGULATIONS. WE GOT A LOT OF USEFUL COMMENTS IN ON OUR PROPOSED RULES THAT ARE REFLECTED IN THE FINAL RULES TO MAKE SURE WE ACHIEVE OUR GOALS WITHOUT IMPOSING ANY UNNECESSARY BURDENS ON FOOD IMPORTERS AND EVERYONE ELSE INVOLVED IN THE FOOD DISTRIBUTION SYSTEM. WE'VE CHANGED VERY SIGNIFICANTLY THE TIME FRAMES REQUIRED FOR PRIOR NOTICE IN THESE REGULATIONS. WE'VE PROVIDED EASY WAYS FOR COMPANIES AND PEOPLE INVOLVED IN FOOD PRODUCTION/DISTRIBUTION TO REGISTER WITH US, SO WE CAN CONTACT THEM IF THERE'S A PROBLEM. WE WANT TO MAKE ALL OF THIS AS SIMPLE AND STRAIGHTFORWARD AS POSSIBLE, BUT WE ALL NEED TO WORK TOGETHER. THERE ARE STEPS THAT EACH AND EVERY ONE OF US CAN TAKE TO MAKE SURE THAT TRADE IN FOOD IS SAFE AND SECURE. THIS IS A GLOBAL PROBLEM THAT WE ALL NEED TO ADDRESS TOGETHER.
NOW, LET ME TALK A LITTLE BIT ABOUT THE FORMAT FOR TODAY'S PROGRAM. WE'RE GOING TO HAVE TWO PANELS OF EXPERTS, THE FIRST ON REGISTRATION OF FOOD FACILITIES, AND THE SECOND ON PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS. WE'LL HAVE A TEN-MINUTE BREAK BETWEEN THE PANELS, AND DURING THE BREAK YOU'LL SEE IMPORTANT INFORMATION ON YOUR SCREEN ABOUT HOW TO SUBMIT COMMENTS ON THESE TWO INTERIM FINAL REGULATIONS TO OUR DOCKETS MANAGEMENT BRANCH. NOW, I'M GOING TO BE ASKING THE PANELISTS QUESTIONS THAT WILL DRAW OUT THE INFORMATION YOU'LL NEED TO KNOW ABOUT COMPLYING WITH THE INTERIM FINAL RULES. YOU'LL ALSO HAVE THE OPPORTUNITY TO ASK QUESTIONS OF THE PANELISTS, EITHER BY PHONE, FAX OR E-MAIL. THE PHONE NUMBER TO CALL IS 1-800-527-1401. THE FAX NUMBER IS 1-888-361-4011. AND THE E-MAIL ADDRESS IS TVQUESTION@CDRH.FDA.GOV. THOSE NUMBERS SHOULD BE APPEARING ON YOUR SCREEN RIGHT NOW, AND THEY'LL REAPPEAR FROM TIME TO TIME DURING THE BROADCAST. NOW, LET ME CLEAR UP A POINT OF POSSIBLE CONFUSION ABOUT YOUR QUESTIONS DURING THIS BROADCAST. WE'RE ENCOURAGING YOU TO ASK QUESTIONS OF OUR PANELISTS TO BE SURE YOU UNDERSTAND THE REGULATIONS. WE'VE ALREADY RECEIVED LITERALLY HUNDREDS OF QUESTIONS AND WE EXPECT TO RECEIVE MANY MORE FROM YOU TODAY. OBVIOUSLY, WE WON'T HAVE TIME TO ANSWER ALL THE QUESTIONS WE RECEIVE, WE'RE GOING TO SELECT THOSE QUESTIONS THAT APPEAR TO BE OF GENERAL INTEREST FIRST. THE QUESTIONS WE DON'T GET TO TODAY, WE'LL TRY TO ANSWER LATER ON OUR WEBSITE. WHEN YOU SUBMIT A QUESTION TODAY DURING THE BROADCAST, BE SURE THAT IT APPLIES TO THESE REGULATIONS IN A GENERAL WAY RATHER THAN TO A SPECIFIC PRODUCT OR A SPECIFIC COMPANY. IN OTHER WORDS, WE'D LIKE YOUR QUESTIONS TO BE OF INTEREST TO AS MANY OF OUR VIEWERS AS POSSIBLE. WELL, NOW LET ME INTRODUCE OUR FIRST PANEL ON THE REGISTRATION OF FOOD FACILITIES. BEFORE I DO, IT'S IMPORTANT TO REMEMBER THAT FOR THIS REGULATION, THE OBLIGATION TO COMPLY WITH THE REGULATION RESTS WITH THE FACILITY. SO THIS PANEL WILL BE OF PARTICULAR INTEREST TO REPRESENTATIVES OF FOOD AND ANIMAL FEED MANUFACTURERS, PROCESSORS, PACKERS, AND HOLDERS OF FOOD. THAT ARE GOING TO BE CONSUMED IN THE U.S. BOB LAKE IS DIRECTOR OF THE OFFICE OF REGULATIONS AND POLICY IN FDA'S CENTER FOR FOOD SAFETY AND APPLIED NUTRITION. LESLYE FRASER IS ASSOCIATE DIRECTOR FOR REGULATIONS IN THAT OFFICE. LANA OGRAM IS DIRECTOR OF THE DIVISION OF COMPLIANCE POLICY IN THE OFFICE OF ENFORCEMENT WITHIN FDA'S OFFICE OF REGULATORY AFFAIRS. AND DR.^RAY RUSSO IS DIRECTOR OF THE DIVISION OF SOFTWARE ENGINEERING SERVICES IN FDA'S OFFICE OF MANAGEMENT AND SYSTEMS. WELL, BOB LAKE, LET'S BEGIN SIMPLY BY ASKING WHY IS IT THAT FDA IS REQUIRING THE REGISTRATION OF FOOD FACILITIES?
LAKE: MARK, THE BIOTERRORISM, OR THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002, OTHERWISE KNOWN AS THE BIOTERRORISM ACT REQUIRES FDA TO TAKE A NUMBER OF STEPS TO BETTER PROTECT THE PUBLIC HEALTH. ONE OF THOSE IS TO REQUIRE FOOD FACILITIES TO REGISTER. THE REGISTRATION INFORMATION WE BELIEVE WILL PUT FDA IN A BETTER POSITION TO DEAL WITH PROBLEMS (*See errata) WITH THE FOOD SAFETY PROBLEMS, WHETHER THOSE ARE INITIATED BY TERRORISTS, OR WHETHER IT'S SIMPLY A ACCIDENTAL CONTAMINATION OF SOME PART OF THE FOOD SUPPLY. WE BELIEVE ALSO THAT HAVING THIS INFORMATION ABOUT FACILITIES WILL ALLOW US TO INTERACT WITH FACILITIES THAT WE NEED TO INTERACT WITH QUICKLY IN THOSE SITUATIONS WHERE WE JOINTLY WILL BE TRYING TO DEAL WITH A FACILITY PROBLEM.
LESLYE, WHO HAS TO REGISTER UNDER THIS REGULATION?
FRASER: THE BURDEN OF REGISTERING IS ON THE OWNER, THE OPERATOR OR THE AGENT IN CHARGE OF ANY DOMESTIC OR FOREIGN FACILITY THAT MANUFACTURES, PROCESSES, PACKS, OR HOLDS FOOD IF THAT FOOD IS INTENDED TO CONSUMPTION BY HUMANS OR ANIMALS IN THE UNITED STATES. THE OWNER, THE OPERATOR, OR THE AGENT IN CHARGE AT EITHER A DOMESTIC OR FOREIGN FACILITY CAN AUTHORIZE SOMEONE TO REGISTER ON THEIR BEHALF, LIKE AN EMPLOYEE, OR IN THE CASE OF A FOREIGN FACILITY, THEY COULD ALSO AUTHORIZE THEIR U.S. AGENT TO REGISTER FOR THEM. I'D LIKE TO NOTE THAT WITH RESPECT TO FACILITIES IN THE UNITED STATES, THEY DO HAVE TO REGISTER IF THEY MANUFACTURE, PROCESS, PACK OR HOLD FOOD, WHETHER OR NOT THAT FOOD ENTERS INTERSTATE COMMERCE.
DO THE FACILITIES, IS THAT FOR ALL FOODS^-- FACILITIES THAT DEAL WITH ALL FOODS?
FRASER: GENERALLY, ALL FOODS UNDER FDA'S JURISDICTION, WITH SOME EXCEPTIONS THAT ARE NOTED IN THE RULE. WE START WITH OUR EXISTING DEFINITION OF "FOOD," WHICH IS IN THE FEDERAL FOOD DRUG AND COSMETIC ACT, AND THAT DEFINES FOOD UNDER OUR JURISDICTION AS ARTICLES USED FOR FOOD OR DRINK, FOR MAN OR OTHER ANIMALS, CHEWING GUM, AND ARTICLES USED FOR COMPONENTS OF ANY SUCH ANIMAL, OR BASICALLY FOOD INGREDIENTS. WE INCLUDE IN THE INTERIM FINAL RULE SOME EXAMPLES OF THE TYPES OF FOOD THAT WE DO REGULATE. THIS IS NOT AN EXHAUSTIVE LIST, BUT IT IS MEANT TO GIVE AN EXAMPLE OF THE DEPTH AND THE SCOPE OF WHAT FDA REGULATES. AND AS SHOWN ON THE SCREEN, THAT INCLUDES DIETARY SUPPLEMENTS, AND DIETARY INGREDIENTS, INFANT FORMULA, BEVERAGES, INCLUDING ALCOHOLIC BEVERAGES AND BOTTLED WATER, FRUITS AND VEGETABLES, FISH AND SEAFOOD, DAIRY PRODUCTS AND SHELL EGGS, RAW AGRICULTURAL COMMODITIES FOR USE AS FOOD OR COMPONENTS OF FOOD, CANNED AND FROZEN FOODS, LIVE FOOD ANIMALS, BAKERY GOODS, SNACK FOOD, CANDY AND CHEWING GUM AND ANIMAL FEEDS AND PET FOOD.
WHAT ABOUT THINGS LIKE FOOD CONTACT SUBSTANCES? I'M THINKING OF PACKAGING, OR LET'S SAY PESTICIDES.
FRASER: YES, THOSE ARE ARTICLES OF FOOD WITHIN OUR JURISDICTION, BUT FOR PURPOSES OF THIS INTERIM FINAL RULE, WE DO EXCLUDE PESTICIDES AND FOOD CONTACT SUBSTANCES, INCLUDING FOOD PACKAGING FROM THE SCOPE OF THE RULE. SO FACILITIES THAT MANUFACTURE, PROCESS, PACK OR HOLD FOOD CONTACT SUBSTANCES OR PESTICIDES DO NOT HAVE TO REGISTER WITH FDA.
NOW, WE'RE USING THE TERM "FACILITY" AND EVERYBODY HAS AN INTUITIVE IDEA OF WHAT A FACILITY MIGHT BE, BUT UNDER THE LAW, WHAT IS A FACILITY?
FRASER: WHAT WE HAVE DEFINED IN THE INTERIM FINAL RULE AS A FACILITY IS AN ESTABLISHMENT OR ONE OR MORE STRUCTURES THAT IS UNDER ONE OWNERSHIP AT ONE GENERAL PHYSICAL LOCATION, AND AGAIN THAT MANUFACTURES, PROCESSES, PACKS OR HOLDS FOOD FOR HUMAN OR ANIMAL CONSUMPTION IN THE U.S. SO IT'S TIED TO LOCATION AND COMMON OWNERSHIP OF THAT LOCATION.
NOW, THERE ARE SOME THINGS THAT ARE NOT FACILITIES UNDER THE LAW.
FRASER: WELL, BEFORE WE GET TO THAT, I'D LIKE TO TALK ABOUT THE TYPES OF FACILITIES THAT ARE INCLUDED. SO, WE COULD HAVE A FACILITY THAT'S ONE PROCESSING PLANT, A LARGE MANUFACTURING COMPANY, FOR EXAMPLE, THAT MAY HAVE MULTIPLE BUILDINGS. AND WE WOULD COUNT THAT AS ONE FACILITY, BECAUSE IT IS IN ONE GENERAL LOCATION UNDER ONE OWNERSHIP. A FACILITY ALSO COULD BE A MOBILE FACILITY THAT TRAVELS FROM SITE TO SITE, AND WHEN IT GETS THERE, IT MAY MANUFACTURE AND PROCESS FOOD, FOR EXAMPLE. AND WE ALSO COULD HAVE A FACILITY THAT HAS ONE MAILING ADDRESS, LET'S SAY IT'S A BUILDING, BUT COMPANY "A" OCCUPIES THE FIRST FLOOR, AND COMPANY "B" OCCUPIES THE SECOND FLOOR, AND BOTH OF THOSE MANUFACTURE OR PROCESS FOOD. WE WOULD COUNT THOSE AS TWO SEPARATE FACILITIES, EVEN THOUGH THEY'RE AT THE SAME LOCATION, BECAUSE THEY HAVE DIFFERENT OWNERS.
NOW, LET'S GET BACK TO WHAT ISN'T A FACILITY.
FRASER: RIGHT. IN THE INTERIM FINAL RULE, WE ALSO DEFINE THINGS THAT ARE NOT FACILITIES, SO THEY DO NOT HAVE TO REGISTER WITH FDA. THE FIRST ARE TRANSPORT VEHICLES IF THEY HOLD FOOD IN THEIR USUAL COURSE OF BUSINESS AS CARRIERS. SO BASICALLY, IF YOU'RE A TRUCK AND YOU HAVE FOOD IN YOUR TRAILER THAT YOU'RE MOVING FROM POINT A TO POINT B, YOU WOULD NOT HAVE TO REGISTER, BECAUSE THAT'S YOUR USUAL COURSE OF BUSINESS AS A CARRIER. HOWEVER, IF THE TRUCKS COME INTO A HOLDING LOCATION, AND THEY TRANSFER FOOD THERE BETWEEN THEMSELVES INTO A HOLDING FACILITY, THAT FACILITY WOULD HAVE TO REGISTER. WE ALSO EXCLUDE A PRIVATE RESIDENCE OF AN INDIVIDUAL, EVEN IF THE PERSON CONDUCTS A FOOD-RELATED BUSINESS FROM THEIR HOME. AND THEN WE ALSO EXEMPT^-- AS FACILITIES, I'M SORRY^-- WE ALSO DON'T COUNT AS FACILITIES NON-BOTTLED DRINKING WATER COLLECTION AND DISTRIBUTION ESTABLISHMENTS, SUCH AS MUNICIPAL WATER SYSTEMS. NONE OF THOSE ARE CONSIDERED FACILITIES.
NOW, THERE ARE ENTITIES UNDER THE LAW THAT WOULD BE CONSIDERED FACILITIES, BUT THAT YOU DO EXEMPT FROM REGISTRATION. IS THAT RIGHT?
FRASER: YES, THERE ARE. THESE ARE FACILITIES, BUT AS YOU NOTED, THEY ARE EXEMPT. AND THERE ARE SIX TO START WITH. THE FIRST IS FARMS, AND FARMS ARE EXEMPT, AND WE DEFINE THEM AS A FACILITY IN ONE GENERAL PHYSICAL LOCATION DEVOTED TO THE GROWING AND HARVESTING OF CROPS, THE RAISING OF ANIMALS, INCLUDING SEAFOOD, OR BOTH. AND A FARM CAN DO SOME MANUFACTURING AND PROCESSING ACTIVITIES OF THE FOOD, PROVIDED ALL OF THE FOOD USED IN SUCH ACTIVITIES IS GROWN, RAISED OR CONSUMED ON THAT FARM, OR ANOTHER FARM UNDER THE SAME OWNERSHIP. THE SECOND EXEMPTION IS FOR RESTAURANTS, WHICH WE DEFINE AS FACILITIES THAT PREPARE AND SELL FOOD DIRECTLY TO CONSUMERS, WHETHER THOSE CONSUMERS ARE HUMANS OR ANIMALS, FOR IMMEDIATE CONSUMPTION. AND SOME EXAMPLES OF RESTAURANTS INCLUDE CAFETERIAS, VENDING MACHINES, PET SHELTERS, KENNELS, AND VETERINARY CLINICS. THE THIRD EXEMPTION IS FOR RETAIL FOOD ESTABLISHMENTS, WHICH WE DEFINE AS ESTABLISHMENTS THAT SELL FOOD PRODUCTS DIRECTLY TO CONSUMERS AS THEIR PRIMARY FUNCTION. WE MEASURE PRIMARY FUNCTION IN TERMS OF WHETHER SALES TO CONSUMERS ARE GREATER THAN THEIR ANNUAL SALES TO OTHER BUYERS, AND WE DO NOT COUNT BUSINESSES AS A CONSUMER IN TERMS OF THE ANNUAL SALES, THE FACILITY CAN CHOOSE WHAT POINT IN TIME THEY WANT TO USE AS THEIR STARTING POINT. FOR EXAMPLE, THEY CAN USE A CALENDAR YEAR, OR THEY CAN USE A FISCAL YEAR. THE FOURTH EXEMPTION IS FOR A NONPROFIT FOOD FACILITY THAT IS RECOGNIZED AS A NONPROFIT BY THE INTERNAL REVENUE SERVICE, AND WE DEFINE THAT AS A CHARITABLE ENTITY THAT PREPARES OR SERVES FOOD DIRECTLY TO THE CONSUMER, OR OTHERWISE PROVIDES FOOD OR MEALS FOR CONSUMPTION BY HUMANS OR ANIMALS IN THE U.S. AND THAT INCLUDES CENTRAL FOOD BANKS, SOUP KITCHENS, AND NONPROFIT FOOD DELIVERY SERVICES. THE FIFTH EXEMPTION IS FOR NONPROCESSING FISHING VESSELS THAT ONLY HARVEST FISH. THEY ALSO MAY DO HEADING OF FISH, EVISCERATING OR FREEZING THE FISH FOR HOLDING ON BOARD THE VESSEL. WE ALSO CLARIFY IN THE RULE THAT MERELY UNLOADING THE FISH ONTO THE DOCK DOES NOT REQUIRE THE FISHING VESSEL TO REGISTER. HOWEVER, THE HOLDING FACILITY ON THE DOCK WOULD HAVE TO REGISTER. AND THEN THE SIXTH EXEMPTION THAT WE HAVE IS FOR FACILITIES THAT MANUFACTURE, PROCESS, PACK OR HOLD MEAT PRODUCTS, POULTRY PRODUCTS OR EGG PRODUCTS THAT ARE REGULATED EXCLUSIVELY THROUGHOUT THE ENTIRE FACILITY BY THE UNITED STATES DEPARTMENT OF AGRICULTURE.
LET'S FOCUS FOR A MOMENT ON FOREIGN FACILITIES. DO THEY ALL HAVE TO REGISTER?
FRASER: GENERALLY, ALL FOREIGN FACILITIES LIKE DOMESTIC FACILITIES THAT MANUFACTURE, PROCESS, PACK OR HOLD FOOD, IF THAT FOOD IS INTENDED FOR CONSUMPTION IN THE UNITED STATES WOULD HAVE TO REGISTER WITH THE FDA. HOWEVER, THERE IS^-- UNLESS THEY WERE OTHERWISE EXEMPTED UNDER ONE OF THE SIX THAT I JUST NOTED. HOWEVER, THERE IS AN ADDITIONAL EXEMPTION THAT ONLY APPLIES TO CERTAIN MANUFACTURING AND PROCESSING FOREIGN FACILITIES, AND THAT IS AFTER THE FIRST MANUFACTURING AND PROCESSING FACILITY, IF THERE IS A SECOND FOREIGN FACILITY, THAT FURTHER MANUFACTURES AND PROCESSES THE FOOD BEFORE IT COMES TO THE UNITED STATES, THEN THE FIRST FOREIGN FACILITY WOULD NOT HAVE TO REGISTER. NOW, THERE'S A COUPLE OF CLARIFICATIONS ON THAT. IF THE SECOND FOREIGN FACILITY IS ONLY DOING SOMETHING WHAT WE CALL A DE MINIMUS ACTIVITY, SUCH AS AFFIXING A LABEL, OR STICKING PLASTIC RINGS AROUND A SIX-PACK, THEN BOTH FOREIGN FACILITIES WOULD HAVE TO REGISTER. WE HAVE GOTTEN A NUMBER OF QUESTIONS ASKING FOR CLARIFICATION ON WHAT ARE DE MINIMUS ACTIVITIES, AND GENERALLY WE DON'T THINK THERE ARE MANY OTHER THAN THE ONES WE HAVE IDENTIFIED WHICH, FROM A FOREIGN FACILITY STANDPOINT, IS PROBABLY GOOD, BECAUSE MOST ACTIVITIES THAT ARE DONE TO AFFECT THE FOOD ITSELF WOULD BE COUNTED AS MANUFACTURING AND PROCESSING, WHICH WOULD EXEMPT ALL UPSTREAM MANUFACTURING AND PROCESSING FOREIGN FACILITIES.
NOW, WHAT IF A FACILITY DOES SOME ACTIVITIES THAT WOULD REQUIRE REGISTRATION, AND THEY DO SOME ACTIVITIES THAT DON'T REQUIRE IT? WHAT HAPPENS THERE?
FRASER: THOSE ARE THE TYPES OF FACILITIES WE CALLED MIXED-TYPE FACILITIES. AND AS LONG AS ANY OF THE FACILITY'S ACTIVITIES FALL UNDER THE SCOPE OF THE RULE, THE FACILITY WOULD HAVE TO REGISTER WITH FDA.
WELL, AN EXAMPLE, LET'S SAY A FARMER GROWS ORANGES. REGISTRATION OR NOT?
FRASER: IF THE FARMER ONLY GREW THE ORANGES, NO, THEY WOULD NOT HAVE TO REGISTER, BECAUSE THEY WOULD BE EXEMPT UNDER THE FARM EXEMPTION. IF THE FARMER THEN TOOK THE ORANGES AND MANUFACTURED AND PROCESSED THEM INTO ORANGE JUICE, AND THEN SOLD THAT ORANGE JUICE INTO A DISTRIBUTOR, FOR EXAMPLE, THE MANUFACTURING AND PROCESSING ACTIVITIES WOULD REQUIRE THE FARM TO BE REGISTERED WITH FDA, UNLESS THEY HAPPEN TO FALL UNDER^-- AS A FOREIGN FARM, THEY FELL UNDER THE FOREIGN FACILITY EXEMPTION, BECAUSE THE JUICE WAS THEN FURTHER MANUFACTURED AND PROCESSED BY ANOTHER FOREIGN FACILITY.
TALK ABOUT DEADLINES. WHEN DOES THE REGISTRATION HAVE TO HAPPEN?
FRASER: ALL FACILITIES SUBJECT TO THE RULE MUST BE REGISTERED WITH FDA BY DECEMBER 12th OF THIS YEAR.
LANA, WHAT IF A FIRM, A FACILITY IS ALREADY REGISTERED WITH THE FDA OR THEY'RE REGISTERED WITH ANOTHER GOVERNMENT AGENCY? WILL THAT SUFFICE, OR DO THEY HAVE TO RE-REGISTER UNDER THIS RULE?
OGRAM: THEY WILL HAVE TO REGISTER. AND THAT IS BECAUSE THE ACT REQUIRES REGISTRATION WITH FDA, EVEN IF A FACILITY HAS REGISTERED WITH FDA OR ANOTHER GOVERNMENT AGENCY UNDER A DIFFERENT PROVISION.
THEN IT MIGHT STRIKE SOME PEOPLE AS BEING REDUNDANT. WHY IS IT THAT THE FDA IS REQUIRING THIS?
OGRAM: THE REGISTRATION INFORMATION REQUIRED BY THE ACT IS SPECIFICALLY GEARED TOWARDS HELPING THE AGENCY PROTECT THE PUBLIC FROM A TERRORIST ATTACK ON THE U.S. FOOD SUPPLY OR TO DEAL WITH ANOTHER FOOD-RELATED EMERGENCY. AND SO A REGISTRATION BY ANOTHER GOVERNMENT AGENCY MAY NOT HAVE THE INFORMATION THAT FDA NEEDS TO FULFILL THIS FUNCTION. ALSO, IN THE EVENT OF AN EMERGENCY, FDA MUST HAVE IMMEDIATE ACCESS TO THAT INFORMATION. AND IF THE DATA WERE OWNED BY A DIFFERENT AGENCY, THERE COULD BE DELAYS IN ACCESSING IT.
NOW, SUPPOSE I'M A COMPANY, AND I HAVE SEVERAL FACILITIES, AND THEY ALL MEET THE DEFINITION AND HAVE TO BE REGISTERED, CAN I REGISTER AS A COMPANY JUST ONCE AND COVER ALL THOSE FACILITIES? OR DOES EVERY ONE OF THEM HAVE TO HAVE ITS OWN REGISTRATION?
OGRAM: A COMPANY MUST REGISTER EACH FACILITY THAT IT OWNS. AND THE ONLINE REGISTRATION SYSTEM HAS BEEN DESIGNED TO FACILITATE THIS PROCESS SO THAT INFORMATION THAT MIGHT BE THE SAME FROM FACILITY-TO-FACILITY WOULD NOT HAVE TO BE REENTERED. FOR EXAMPLE, THE NAME AND ADDRESS OF THE PARENT COMPANY. THE REGULATION ALSO PROVIDES FOR REGISTRATION OF MULTIPLE FACILITIES IN CD-ROM.
BOB, WHAT INFORMATION DOES THE REGISTRATION REQUIRE?
LAKE: OKAY, MARK. I BELIEVE WE HAVE SOME SLIDES TO HELP OUR VIEWERS WITH THIS ONE. FIRST, THE NAME OF THE FACILITY, THE FULL ADDRESS AND THE PHONE NUMBER. THE SAME INFORMATION IS ALSO REQUIRED OF A PARENT COMPANY, IF THERE IS ONE. THE NAME, ADDRESS AND PHONE NUMBER OF THE OWNER, OPERATOR, OR AGENT IN CHARGE, ALL TRADE NAMES USED BY THE FACILITY, THE NAME OF THE U.S. AGENT AND CONTACT INFORMATION, THAT IS FOR FOREIGN FACILITIES. EMERGENCY CONTACT PHONE NUMBER FOR DOMESTIC FACILITIES, FOOD PRODUCT CATEGORIES AS DESCRIBED IN THE REGULATION AND, FINALLY, A STATEMENT THAT THE INFORMATION SUBMITTED IS TRUE AND ACCURATE, AND THAT THE INDIVIDUAL SUBMITTING THE FORM, IF THEY ARE NOT THE OWNER, OPERATOR OR AGENT IN CHARGE, IS AUTHORIZED TO DO SO.
YOU TALKED ABOUT A U.S. AGENT. WHAT ARE THE REQUIREMENTS TO BE A U.S. AGENT? AND, ONCE YOU ARE A U.S. AGENT, WHAT DO YOU DO? WHAT'S THE ROLE?
LAKE: WELL, MARK, WE'VE TRIED TO KEEP THESE REQUIREMENTS TO A MINIMUM. OWNERS, OPERATORS AND FACILITIES OF^-- FOREIGN FACILITIES, ARE REQUIRED TO IDENTIFY A U.S. AGENT. THAT AGENT MUST BE SOMEONE WHO RESIDES OR MAINTAINS A PLACE OF BUSINESS IN THE UNITED STATES AND IS PHYSICALLY PRESENT. A MAILBOX OR ANSWERING MACHINE OR ANYTHING^-- OR ANY OTHER PLACE THAT (*See errata) DOES NOT CORRESPONDENCE TO THE PHYSICAL LOCATION OF THE AGENT IS NOT (*See errata) ACCEPTABLE. THE ROLE OF THE U.S. AGENT IS TO SERVE AS THE COMMUNICATIONS LINK BETWEEN THE FDA AND THE FACILITY, BOTH FOR ROUTINE COMMUNICATIONS AND FOR EMERGENCIES. WE DO PROVIDE THAT A FOREIGN FACILITY MAY, IF THEY WISH, DESIGNATE SOMEONE ELSE TO BE THE EMERGENCY CONTACT. BUT IF^-- AND WE WILL HONOR THAT IN THE EVENT OF AN EMERGENCY, BUT IF WE ARE UNABLE TO CONTACT THAT PERSON, THEN WE WILL CONTACT THE U.S. AGENT. AND IF NO ONE OTHERWISE IS DESIGNATED, WE WILL CONSIDER THE EMERGENCY CONTACT FOR THE FOREIGN FACILITY TO BE THE U.S. AGENT.
NOW, YOU TALKED ABOUT THE U.S. AGENT ACTING AS A LIAISON OR CONTACT, BUT CAN THEY ACTUALLY REGISTER THE FOREIGN FACILITY?
LAKE: YES, MARK, THEY MAY. IF THE FOREIGN FACILITY WANTS THEIR U.S. AGENT OR AUTHORIZES THEIR U.S. AGENT TO DO THE REGISTRATION, THEN THAT IS ACCEPTABLE TO FDA.
WHAT KIND OF ENTITIES CAN ACT AS A U.S. AGENT? LET'S GET SOME EXAMPLES OF WHO COULD DO THIS.
LAKE: WELL, WE EXPECT MANY FOREIGN FACILITIES TO IDENTIFY AN IMPORTER, A BROKER, A TRADE ASSOCIATION. BUT, ACTUALLY, ALMOST ANYONE COULD BE DESIGNATED AS A U.S. AGENT, SO LONG AS THEY MAINTAIN A PRESENCE IN THE UNITED STATES.
LET ME PAUSE FOR A MOMENT TO URGE OUR AUDIENCE TO SEND QUESTIONS IN. WE'RE GOING TO BE PAUSING IN A FEW MINUTES AND TAKING YOUR QUESTIONS ON REGISTRATION. SO FAX THEM, PHONE THEM IN, E-MAIL THEM IN. WE'RE EAGER TO GET THEM. AS I SAID EARLIER, WE HAVE A PILE OF QUESTIONS THAT CAME IN BEFORE THE BROADCAST, BUT WE'D LIKE TO ADD TO THOSE WITH YOUR QUESTIONS DURING THE BROADCAST. SO DON'T HESITATE TO GET THOSE INTO US. LESLYE, BOB TALKED ABOUT REQUIRED INFORMATION, BUT WHAT ABOUT^-- I THINK THE FDA IS ENCOURAGING PEOPLE TO ADD SOME OPTIONAL INFORMATION AS WELL. IS THAT RIGHT?
FRASER: YES, WE ARE. AND SOME OF THE INFORMATION WE ARE REQUESTING IS OPTIONAL INFORMATION ARE^-- IS INFORMATION THAT WE THINK WILL HELP US COMMUNICATE BETTER WITH FACILITIES. FOR EXAMPLE, WE'VE ASKED FOR THE E-MAIL ADDRESS, THE FAX NUMBER AND FOOD PRODUCT CATEGORIES THAT ARE NOT REQUIRED BY OUR ACT, SUCH AS INFANT FORMULA, DIETARY SUPPLEMENTS OR ANIMAL FEED. AND YET, IF THERE IS A FOOD-RELATED EMERGENCY WITH RESPECT TO THOSE FOOD PRODUCTS, WE WANT TO BE ABLE TO CONTACT THE AFFECTED FACILITIES. OTHER INFORMATION THAT WE HAVE REQUESTED IS INFORMATION THAT COMPANIES ASKED US TO INCLUDE, SUCH AS THE PREFERRED MAILING ADDRESS. FOR EXAMPLE, WE HEARD FROM A NUMBER OF COMMENTERS THAT A CORPORATE HEADQUARTERS MAY WANT TO REGISTER ALL OF ITS FACILITIES, EVEN THOUGH IT IS A FACILITY-BY-FACILITY REGISTRATION, AND THAT BY ALLOWING THEM TO INCLUDE THE PREFERRED MAILING ADDRESS AND TO RECEIVE COMMUNICATION FROM FDA AT THAT ADDRESS, THAT WILL BE BETTER FOR THEIR OPERATIONS. I JUST WANTED TO NOTE THAT BOTH, BY PROVIDING THE OPTIONAL INFORMATION GENERALLY DOES NOT EXCUSE ONE FROM COMPLETING THE MANDATORY INFORMATION, WITH THE EXCEPTION OF THE MOST ALL FOOD PRODUCT CATEGORY.
HOW OFTEN DOES THE REGISTRATION TAKE PLACE? IS IT AN ANNUAL THING, YOU RENEW IT?
FRASER: IT'S BASICALLY A ONE-TIME REGISTRATION REQUIREMENT, UNLESS THERE ARE CHANGES TO THE REGISTRATION INFORMATION.
AND WHAT ABOUT A FEE?
FRASER: THERE IS NO FEE.
NOW, YOU TALKED ABOUT THINGS CHANGING. WHAT, IN FACT, IS THE^-- IF THE INFORMATION CHANGES? DO YOU RE-REGISTER?
FRASER: YOU DO NOT RE-REGISTER, BUT YOU UPDATE THE INFORMATION. AND IT IS A REQUIREMENT THAT, IF ANY OF THE REQUIRED INFORMATION THAT BOB TALKED ABOUT CHANGES, THEN THE FACILITY MUST UPDATE ITS REGISTRATION WITHIN 60^DAYS OF THE CHANGE. THERE IS NO REQUIREMENT IN THE INTERIM FINAL RULE TO UPDATE OPTIONAL INFORMATION. BUT, OBVIOUSLY, THE AGENCY IS VERY INTERESTED IN HAVING THAT INFORMATION BE AS ACCURATE AS POSSIBLE FOR THE REASONS WE JUST TALKED ABOUT. AND UPDATES CAN BE PROVIDED OVER THE INTERNET, JUST LIKE YOU DID WHEN YOU INITIALLY REGISTERED, OR WE CAN ACCEPT UPDATES BY PAPER OR CD-ROM AS WELL.
WHAT IF A COMPANY GOES OUT OF BUSINESS OR LET'S SAY IT'S SOLD? THAT'S AN EXTREME CHANGE. WHAT DO YOU DO THERE?
FRASER: THAT IS A^-- A RELATIVELY EXTREME CHANGE, AND IT WOULD REQUIRE AN UPDATE ALSO WITHIN 60^DAYS. AND HERE, TWO TYPES OF INFORMATION WOULD BE REQUIRED IF A FACILITY IS SOLD. IF IT IS SOLD, THE FORMER OWNER NEEDS TO CANCEL ITS REGISTRATION WITHIN 60^DAYS OF THE CHANGE, AS WE JUST TALKED ABOUT. BUT IMPORTANTLY, THE NEW OWNER WOULD HAVE TO RE-REGISTER THE FACILITY BEFORE THAT OWNER BEGAN TO MANUFACTURE, PROCESS, PACK OR HOLD FOOD FOR CONSUMPTION IN THE UNITED STATES, BECAUSE WE DO NOT TRANSFER REGISTRATION NUMBERS FROM ONE OWNER TO ANOTHER.
RAY, TELL US A LITTLE BIT ABOUT HOW FACILITIES REGISTER, WHERE THEY DO IT AND SO ON.
RUSSO: MARK, REGISTRANTS MUST USE FORM 3537^TO REGISTER. FDA RECOMMENDS ONLINE REGISTRATION VIA THE INTERNET AT THE ADDRESS THAT YOU SHOULD BY SEEING ON YOUR SCREEN RIGHT NOW, WHICH IS WWW.ACCESS.FDA.GOV. THAT WEBSITE IS AVAILABLE ESSENTIALLY 24^HOURS A DAY, SEVEN DAYS A WEEK AND CAN BE ACCESSED WHEREVER THE INTERNET IS AVAILABLE, INCLUDING SCHOOLS, LIBRARIES, COPY CENTERS AND INTERNET CAFES. THE WEBPAGE THAT YOU SHOULD BE SEEING ON YOUR SCREEN RIGHT NOW SHOWS THE PAGE WHERE YOU GET YOUR I.D. AND PASSWORD AND SECURELY LOGIN TO REGISTER A FACILITY. REGISTRATION CAN ALSO BE DONE ON A PAPER FORM AVAILABLE FROM FDA.
NOW, THE SYSTEM HAS BEEN UP AND RUNNING SINCE OCTOBER 16th?
RUSSO: YES.
HOW MANY FIRMS ARE ON IT RIGHT NOW?
RUSSO: AS OF YESTERDAY, OCTOBER 27th, APPROXIMATELY 12,000^FIRMS^-- EXCUSE ME, FACILITIES HAVE REGISTERED. ABOUT 8,000^OF THOSE HAVE BEEN FOREIGN AND ABOUT 4,000^DOMESTIC. NOW, FDA ESTIMATES THAT THERE ARE OVER 400,000^FACILITIES THAT HAVE TO REGISTER. WE DON'T WANT ALL OF THOSE TRYING TO REGISTER AT THE LAST MINUTE BEFORE DECEMBER 12th. WE'D LIKE FOR SOME FAIRLY EVEN DISTRIBUTION OF REGISTRATION BETWEEN NOW AND THE DECEMBER 12th DEADLINE.
SO YOU'RE SAYING, AS SOON AS POSSIBLE, DO IT.
RUSSO: AS SOON AS THEY'RE READY, THEY SHOULD GO ONLINE AND REGISTER.
YEAH, WHAT IF THEY NEED HELP?
RUSSO: WELL, MARK, THERE ARE MANY TYPES OF ASSISTANCE THAT WE HAVE AVAILABLE. AGAIN, THEY SHOULD BE SEEING ON THEIR SCREEN THAT WE HAVE ANIMATED TUTORIALS AVAILABLE, WE HAVE ANSWERS TO FREQUENTLY ASKED QUESTIONS, WE HAVE WRITTEN INSTRUCTIONS. ALL OF THOSE ARE AVAILABLE, AGAIN, AT THE WEBSITE, WWW.ACCESS.FDA.GOV. IN THE SYSTEM ITSELF, WE ALSO HAVE A HELP BUTTON THAT PROVIDES PAGE-LEVEL HELP, IF YOU NEED IT. AND, FINALLY, WE HAVE A HELP DESK THAT PEOPLE CAN CALL. AND, AGAIN, YOU SHOULD BE SEEING ON YOUR SCREEN THAT THE REGISTRATION HELP DESK OPERATES FROM 7:00^A.M. TO 11:00^P.M., U.S. EASTERN TIME, MONDAY THROUGH FRIDAY, EXCEPT HOLIDAYS. YOU CAN CALL IT IN THE U.S. AT 1-800-216-7331. FROM OUTSIDE THE U.S., YOU CAN CALL IT AT 301-575-0156. YOU CAN FAX QUESTIONS TO IT AT 301-210-0247. AND, FINALLY, YOU CAN E-MAIL QUESTIONS TO IT AT FURLS@FDA.GOV.
NOW, HAVING SEEN THE SYSTEM WORK FOR AWHILE, WHAT ADVICE WOULD YOU GIVE PEOPLE THAT ARE GETTING READY TO REGISTER?
RUSSO: WELL, IT'S FAIRLY TYPICAL ADVICE FOR SYSTEMS LIKE THIS. FIRST, MAKE SURE YOU GATHER TOGETHER ALL OF THE MATERIALS AND INFORMATION YOU NEED BEFORE YOU GET STARTED AND HAVE THEM ON HAND. TWO, YOU NEED TO THEN GO TO THE WEBSITE, GET YOUR PASSWORD AND I.D. SO YOU CAN SECURELY ACCESS THE SYSTEM AND GET STARTED WHEN YOU'RE READY. DON'T WAIT UNTIL DECEMBER 12th. AND THREE, IF YOU DO NEED ASSISTANCE USE ALL OF THOSE THE MATERIALS I ALLUDED TO BEFORE, OR CALL THE HELP DESK IF YOU NEED ASSISTANCE.
NOW, WHAT IF YOU CAN'T ACCESS THE INTERNET? I MEAN, YOU TALKED ABOUT IT BEING AVAILABLE IN VARIOUS PLACES. BUT THERE ARE GOING TO BE INSTANCES WHERE YOU CANNOT GET TO THE INTERNET. CAN YOU DO IT IN PAPER, AND HOW DO YOU GET THE PAPER FORM?
RUSSO: YES, MARK. IF YOU CAN'T ACCESS THE INTERNET, A PAPER FORM IS AVAILABLE FROM THE FDA. YOU SHOULD BE SEEING ON YOUR SCREEN THAT YOU CAN OBTAIN A COPY OF THE FORM BY CALLING, IN THE U.S., 1-800-216-7331, OR FROM OUTSIDE THE U.S. AT 301-575-0156. OR YOU CAN ALSO MAIL TO THE ADDRESS THAT'S ON THE SCREEN, WHICH IS U.S. FOOD & DRUG ADMINISTRATION, HFS 681, 5600^FISHERS LANE, ROCKVILLE, MARYLAND, 20857, USA.
RAY, THANK YOU. YOU KNOW, RAY^-- BOB, RAY WAS MENTIONING THAT YOU SEEM TO BE (*See errata) ENCOURAGING ONLINE REGISTRATION AS OPPOSED TO PAPER. WHY IS THAT?
LAKE: WELL, THAT IS CORRECT, MARK. WE ARE ENCOURAGING USE OF THE ONLINE SYSTEM. AND THE MAIN REASON FOR THAT IS, WE BELIEVE IT IS THE LEAST COSTLY AND MOST EFFICIENT SYSTEM, BOTH FOR FACILITIES AND ALSO FOR FDA. THE SYSTEM IS DESIGNED TO HELP PEOPLE WALK THROUGH THE SYSTEM. FOR INSTANCE, IF INFORMATION IS INCOMPLETE, THE SYSTEM WILL PROMPT YOU TO FILL IN THAT INFORMATION. BUT MOST IMPORTANT OF ALL, ONCE THE INFORMATION IS COMPLETE AND THE FORM IS SUBMITTED OVER THE WEB, THERE IS AN IMMEDIATE CONFIRMATION, AND A REGISTRATION NUMBER COMES BACK FROM FDA RIGHT THERE, SO THAT YOU GET IT AS PART OF THE REGISTRATION PROCESS. ON THE OTHER HAND, IF YOU TRY TO REGISTER BY PAPER, I MEAN, WE WILL DO THAT, BUT THAT'S GOING TO BE A MUCH SLOWER, MORE COSTLY SYSTEM. WE HAVE TO GET THE^-- YOU KNOW, THE MAILING, WE HAVE TO RE-KEYPUNCH THE INFORMATION OURSELVES. AND, IF THE INFORMATION IS INCOMPLETE, WE WILL NOT BE ABLE TO PROCESS IT. SO WE BELIEVE THAT'S GOING TO BE A MUCH MORE CUMBERSOME SYSTEM. AND WE, THEREFORE, STRONGLY ENCOURAGE PEOPLE TO USE THE WEB-BASED SYSTEM.
LANA, BOB MENTIONED A REGISTRATION NUMBER THAT WOULD COME BACK IMMEDIATELY. DOES THAT NUMBER IMPLY AN ENDORSEMENT BY THE FDA OF THE REGISTRATION OR OF THE FACILITY?
OGRAM: NO, IT DOESN'T. THE REGISTRATION NUMBERS MEANS ONLY THAT A FACILITY HAS COMPLIED WITH THE REQUIREMENT TO REGISTER UNDER THIS REGULATION. IT DOES NOT CONVEY AN APPROVAL OR AN ENDORSEMENT OF THE FIRM, THE FACILITY, OR ITS PRODUCT.
WELL, NOW THAT THE FDA HAS THE INFORMATION, WHAT DOES IT DO WITH IT?
OGRAM: THE INFORMATION WILL BE USED TO CONTACT AFFECTED FACILITIES IN THE EVENT THAT WE RECEIVE INFORMATION THAT WOULD LEAD US TO BELIEVE THERE MIGHT BE A TERRORIST ATTACK ON THE U.S. FOOD SUPPLY, OR TO DEAL WITH ANOTHER FOOD-RELATED EMERGENCY. IT WILL ALSO HELP US TO WORK MORE EFFICIENTLY WITH OTHER RESPONSIBLE FEDERAL, STATE AND LOCAL GOVERNMENT AGENCIES, AS WELL AS THE FIRM AND ITS DISTRIBUTION SYSTEM, TO EITHER PREVENT A CONTAMINATION OR TO LIMIT ITS IMPACT ON THE PUBLIC.
LET'S TALK A LITTLE BIT ABOUT THE PRIVACY ISSUE. IS THIS INFORMATION GOING TO BE AVAILABLE, LET'S SAY, TO THE PUBLIC OR TO OTHER FIRMS THAT ARE REGISTERING?
OGRAM: NO, IT WILL NOT BE AVAILABLE. AND THAT WOULD INCLUDE THE LIST OF REGISTERED FIRMS, THE REGISTRATION DOCUMENTS AND ANY INFORMATION THAT MIGHT BE DERIVED FROM THE LIST OR THE DOCUMENTS THAT WOULD REVEAL THE IDENTIFY OR LOCATION OF A REGISTERED PERSON. THAT WOULD NOT BE CONSIDERED PUBLICLY AVAILABLE INFORMATION RELEASABLE UNDER THE FREEDOM OF INFORMATION ACT. NOW, THERE ARE A COUPLE OF INSTANCES WHERE THAT INFORMATION MIGHT BE DISCLOSED. AND THAT WOULD BE, IF IT HAD ALREADY BEEN DISCLOSED OR IF IT HAD BEEN OBTAINED BY OTHER MEANS.
NOW, YOU'RE SAYING THAT IT'S NOT AVAILABLE TO THE GENERAL PUBLIC, IT'S NOT AVAILABLE TO THE COMPETITOR WHO MAY ALSO BE A REGISTRANT. WHAT ABOUT MAKING IT AVAILABLE TO, LET'S SAY, OTHER FEDERAL AGENCIES OR STATE AGENCIES OR FOREIGN GOVERNMENTS?
OGRAM: YES. WE CAN MAKE THAT TYPE OF INFORMATION AVAILABLE TO OTHER FEDERAL, STATE AND FOREIGN GOVERNMENT AGENCIES, AS LONG AS WE FOLLOW OUR REGULATIONS AND PROCEDURES COVERING INFORMATION-SHARING.
NOW, ARE YOU THEN ASSUMING THAT THE OTHER GOVERNMENT AGENCY ISN'T GOING TO MAKE IT AVAILABLE TO THE PUBLIC?
OGRAM: NO, WE DON'T ASSUME THAT. OUR PROCEDURES REQUIRE THAT A RECIPIENT, ANOTHER AGENCY, WOULD ASSURE TO US, IN WRITING, THAT THEY WOULD MAINTAIN THE CONFIDENTIALITY OF THAT INFORMATION.
LET'S START TALKING A LITTLE BIT, LANA, ABOUT CONSEQUENCES. WHAT HAPPENS IF THE FDA DISCOVERS THAT A FACILITY THAT SHOULD HAVE REGISTERED HAS NOT DONE SO?
OGRAM: THE BIOTERRORISM ACT MAKES IT A PROHIBITED ACT TO FAIL TO REGISTER. AND THAT WOULD BE FOR BOTH A DOMESTIC OR FOREIGN FIRM. AND, IN THAT CASE, THE FEDERAL GOVERNMENT CAN BRING EITHER A CIVIL OR A CRIMINAL ACTION IN FEDERAL COURT AGAINST A PERSON OR PERSONS WHO COMMIT A PROHIBITED ACT.
LET'S TALK WHAT HAPPENS TO THE SHIPMENT. LET'S SAY, A FIRM SHIPS SOMETHING THEY SHOULD HAVE REGISTERED, THEY DON'T, THE IMPORT ARRIVES. WHAT HAPPENS THEN?
OGRAM: IT WOULD BE REFUSED ENTRY OR HELD AT THE PORT OF ENTRY, OR IT COULD BE MOVED TO ANOTHER LOCATION, A SECURED FACILITY IF EITHER FDA OR CUSTOMS AND BORDER PROTECTION DIRECT THAT.
NOW, THE REGISTRATION REQUIREMENT GOES INTO EFFECT DECEMBER 12th. CAN WE ASSUME ON DECEMBER 13th, THAT THE KIND OF THING YOU JUST DESCRIBED IS GOING TO HAPPEN?
OGRAM: ACCORDING TO THE STATEMENTS MADE BY COMMISSIONER McCLELLAN AT THE BEGINNING OF THIS PROGRAM, WE WILL BE WORKING HARD TO PROTECT THE PUBLIC HEALTH. AND FDA WILL FOCUS ITS RESOURCES DURING THE FIRST FOUR MONTHS AFTER DECEMBER 12th ON EDUCATION AND TRAINING TO HELP REGISTERED^-- OR TO HELP FACILITIES IN THE INDUSTRY COMPLY WITH THE REGISTRATION REGULATIONS.
BOB, WHAT ABOUT THE FDA'S OBLIGATIONS UNDER THE WORLD TRADE ORGANIZATION AND NAFTA? HOW DOES REGISTRATION AFFECT THAT, IF IT DOES AT ALL?
LAKE: WELL, MARK, NEITHER THE REGULATION NOR THE STATUTE UNDERPINNING IT HAS ANY IMPACT OF FDA'S OBLIGATIONS UNDER THE WORLD TRADE ORGANIZATION OR NAFTA. WE BELIEVE THAT WE HAVE DEVELOPED THESE REGULATIONS IN A WAY THAT IS CONSISTENT WITH OUR TRADE AND OTHER INTERNATIONAL OBLIGATIONS. ALSO, I WOULD LIKE TO NOTE THAT, WHEN WE PUBLISHED OUR PROPOSED RULES EARLIER THIS YEAR, WE DID OFFICIALLY NOTIFY THE WORLD TRADE ORGANIZATION OF THESE PROPOSALS. AND WITH THE PUBLICATION OF THE REGULATIONS, WE HAVE FILED ADDENDUMS TO THAT NOTIFICATION TO THE WTO.
WHAT'S THE FDA DOING TO MAKE SURE THAT FACILITIES THAT NEED TO REGISTER KNOW ABOUT THIS NEED AND THEY KNOW HOW TO DO IT?
LAKE: WELL, OF COURSE, THIS SATELLITE DOWNLINK IS ONE OF THE THINGS WE'RE DOING. BUT IN ADDITION TO THAT, WE ARE CONTINUING WITH THE EFFORTS THAT WE BEGAN WHEN WE FIRST PUBLISHED THE PROPOSALS WAY BACK IN FEBRUARY OF THIS YEAR. AND NOW THAT WE HAVE PUBLISHED THE REGULATIONS ON OCTOBER THE 10th, WE HAVE SCHEDULED SEVERAL MEETING^-- PUBLIC MEETINGS IN SEVERAL MAJOR (*See errata) CITIES OF THE UNITED STATES TO DISCUSS THESE REGULATIONS AND HOW TO COMPLY WITH THEM. THE INFORMATION ABOUT THE PLACES AND TIMES AND DATES FOR THESE MEETINGS WILL BE POSTED ON THE WEBSITE. THAT'S ON THE DOMESTIC SIDE. ON THE INTERNATIONAL FRONT, WE HAVE^-- WILL BE MEETING WITH SEVERAL (*See errata) GOVERNMENTS TO TALK ABOUT THESE REGULATIONS. WE ALSO, IN COOPERATION WITH THE WORLD BANK, HAVE SCHEDULED A SERIES OF VIDEOCONFERENCES IN WHICH WE WILL BE TALKING ABOUT BOTH OF THESE REGULATIONS, AND THESE ARE DESIGNED TO TARGET DIFFERENT PARTS OF THE WORLD AT DIFFERENT TIMES. BUT WE INTEND TO REACH THE WHOLE GLOBE WITH OUR OUTREACH EFFORTS.
ASIDE FROM MEETINGS AND VIDEOCONFERENCES, WHERE CAN PEOPLE GO THAT NEED INFORMATION ON HOW TO COMPLY?
LAKE: WELL, THERE ARE SEVERAL PIECES OF INFORMATION. ONE, THE FACT SHEETS, THE REGULATIONS THEMSELVES, TUTORIALS THAT HAVE BEEN CREATED THAT RAY REFERRED TO EARLIER TO HELP PEOPLE USE THE WEB-BASED SYSTEM, THESE PIECES OF INFORMATION CAN BE FOUND AT FDA^-- AT WWW.FDA.GOV.
AND YOU'VE GOT A PUBLICATION AS WELL.
LAKE: YES, A NEW PUBLICATION ENTITLED^-- I KEEP FORGETTING.
"WHAT DO I NEED TO KNOW^--"
LAKE: YEAH, "WHAT DO I NEED TO KNOW ABOUT FDA'S NEW BIOTERRORISM REGULATIONS?" THIS IS IN PRESS AND WILL BE GIVEN TO STATE GOVERNMENTS, TRADE ASSOCIATIONS, EMBASSIES AND WILL ALSO BE PUT UP ON THE WEB. FINALLY, THE^-- ALL OF THE INFORMATION WE'VE BEEN TALKING ABOUT IS BEING PUT ON A CD AND WILL BE AVAILABLE IN ENGLISH, FRENCH AND SPANISH. AND WE WILL BE PUTTING INFORMATION ON THE WEB ON HOW TO GET THAT CD IN THE NEAR FUTURE.
SUPPOSE A FACILITY SIMPLY ISN'T SURE ABOUT WHETHER THE REGULATIONS APPLY TO THEM AND HOW THEY APPLY AND SO ON. HOW DO THEY GET INFORMATION ON THAT?
LAKE: WELL, THERE ARE TWO ASPECTS TO THAT. FIRST, WE, OF COURSE, GOT A LOT OF COMMENTS TO THE PROPOSAL AND SPENT A LOT OF TIME ANSWERING THOSE AND BELIEVE THAT THE ANSWERS TO MANY QUESTIONS THAT PEOPLE HAVE ARE ACTUALLY IN THE PREAMBLE. TO FACILITATE USE OF THOSE ANSWERS AND THOSE PREAMBLE DISCUSSIONS, WE HAVE INDEXED THE PREAMBLE ON OUR WEB, SO THAT PEOPLE CAN GO DIRECTLY TO THE TOPICS THAT THEY'RE MOST INTERESTED IN. IN ADDITION TO THAT, AS YOU INDICATED EARLIER, WE WILL BE PUTTING ADDITIONAL Q's AND A's ON THE WEBSITE.
OKAY, WE HAVE A LARGE LIST OF FAXES AND E-MAILS THAT CAME IN BEFORE THE BROADCAST. WE HAVE A WHOLE BUNCH THAT JUST CAME IN, IN THE LAST FEW MINUTES. WE'RE NOT GOING TO BE ABLE TO COVER ALL OF THESE. WE'LL COVER AS MANY AS WE CAN. AND I'M GOING TO ASK YOU TO KEEP YOUR ANSWERS FAIRLY BRIEF SO THAT WE CAN DO AS MANY AS POSSIBLE. I'M SIMPLY GOING TO AIM THEM AT THE PERSON WHO SEEMS TO BE MOST ELIGIBLE TO ANSWER THESE. THE FIRST ONE SEEMS TO BE FOR YOU, BOB. IT SAYS, "ARE LOCAL COLLECTING FACILITIES FOR GRAINS EXEMPTED FROM THE REGISTRATION REQUIREMENTS?"
LAKE: IF BY "COLLECTION," THERE IS STORAGE INVOLVED, SO THAT SEVERAL PEOPLE ARE BRINGING GRAINS INTO A STORAGE FACILITY, EVEN IF IT'S FOR A RELATIVELY SHORT PERIOD OF TIME, THAT IS A FACILITY THAT SHOULD BE REGISTERED.
OKAY, RAY, "CAN AN ENTITY ACTING AS A U.S. AGENT FOR MULTIPLE FOREIGN FACILITIES OPEN AN ENTERPRISE ACCOUNT WITH FDA AND SUBACCOUNTS FOR EACH OF THE FOREIGN FACILITIES IT REPRESENTS?"
RUSSO: YES, THE SYSTEM IS DESIGNED WITH A FAIR AMOUNT OF FLEXIBILITY IN TERMS OF THE ACCOUNT STRUCTURE. AND THAT IS ONE WAY THAT IT CAN BE DONE. AND THE SUBACCOUNTS FOR EACH OF FACILITY CANNOT SEE WHAT'S IN THE OTHER SUBACCOUNT. AND THE U.S. AGENT CAN OVERSEE THEM, IF THAT'S WHAT'S DESIRED.
OKAY, LESLYE, "IS FUMIGATION, SUCH AS BAD COCOA BEANS, CONSIDERED A DE MINIMUS PROCESSING?"
FRASER: NO, IT IS NOT. THAT IS SOMETHING THAT IS AFFECTING THE FOOD. WE WOULD COUNT THAT AS A MANUFACTURING PROCESSING ACTIVITY.
BOB LAKE, "IF PRODUCTS ARE HELD AT A THIRD-PARTY FACILITY BEFORE CONSOLIDATION FOR EXPORT, MUST THIS FACILITY BE REGISTERED?"
LAKE: MARK, THAT DEPENDS. IF THE FACILITY IS STORING FOOD ONLY FOR EXPORT, THEN THEY WOULD NOT HAVE TO REGISTER, BECAUSE THE^-- THESE REGULATIONS APPLY TO FOOD THAT IS TO BE CONSUMED IN THE UNITED STATES. SO, IF IT'S STRICTLY FOR EXPORT, THEN THEY WOULD NOT HAVE TO REGISTER. ON THE OTHER HAND, IF THEY HAVE A MIX OF SOME THINGS FOR EXPORT AND SOME FOR DOMESTIC USE, THEN THEY WOULD HAVE TO REGISTER. BARNETT; OKAY, THIS ONE JUST CAME IN, IN FACT, DURING THE BROADCAST. IT SAYS, "SOME U.S. LAW FIRMS ARE CHARGING EXCESSIVE FEES FOR REGISTRATION. SOME ARE USING NAMES THAT ARE SIMILAR TO FDA, CAUSING CONFUSION. WHAT ARE THE FDA REQUIREMENTS FOR AGENTS?" I'LL THROW THAT OUT TO ANYBODY.
FRASER: I'LL ANSWER THAT ONE. FDA DOES NOT RECOMMEND OR ENDORSE ANY PARTICULAR FIRM FOR REGISTRATION PURPOSES OR FOR U.S. AGENT PURPOSES, AND THERE IS A NOTICE ON OUR WEBSITE TO THAT EFFECT. WE, AS BOB NOTED, WE ONLY REQUIRE AS U.S. AGENT QUALIFICATIONS, THE PERSON RESIDE OR MAINTAIN A PLACE OF BUSINESS HERE AND BE PHYSICALLY PRESENT. AND OTHER THAN THAT, ANYONE CAN SERVE IN THAT CAPACITY. WE RECOMMEND THAT PEOPLE TALK TO THEIR OTHER BUSINESSPEOPLE, TALK TO THEIR TRADE ASSOCIATIONS AND OTHER ENTITIES TO FIND RECOMMENDATIONS THAT PEOPLE FIND APPROPRIATE TO BE U.S. AGENTS.
LAKE: LET ME ADD TO THAT, BECAUSE THE OTHER PART OF THE QUESTION IS THAT (*See errata) EXCESSIVE FEES. THESE ARE ALL, OF COURSE, ENTREPRENEURS DOING WHAT ENTREPRENEURS EVERYWHERE DO. THAT IS OUTSIDE OF FDA'S JURISDICTION. LIKE ANYTHING ELSE, IF PEOPLE ARE CONCERNED ABOUT PRICE, THEY SHOULD SHOP AROUND.
OKAY. I'LL THROW THIS ONE OUT TO THE GROUP AT LARGE. IT SAYS, "CAN AN EMBASSY OR AN EMPLOYEE AT THE EMBASSY IN THE U.S. BE AN AGENT FOR A FOREIGN FACILITY?"
LAKE: LET ME TAKE THAT ONE. I THINK THOSE ARE GOING TO HAVE TO BE ANSWERED ON A CASE-BY-CASE BASIS. BUT IT'S MY UNDERSTANDING THAT^-- THAT DIPLOMATS, THE STATE (*See errata) DEPARTMENT HAS SOME CONCERN ABOUT DIPLOMATS SERVING IN A COMMERCIAL CAPACITY, AND THIS WOULD CLEARLY BE A COMMERCIAL CAPACITY. BUT I THINK ANY GOVERNMENT THAT^-- THAT HAS A QUESTION ABOUT THAT SHOULD CONTACT FDA, AND WE WILL WORK TOGETHER WITH THE STATE DEPARTMENT AND GET AN ANSWER.
OKAY. "DO WAREHOUSE CLUBS THAT SELL TO BOTH CONSUMERS AND BUSINESSES HAVE TO REGISTER, OR ARE THEY CONSIDERED A MIXED-TYPE FACILITY?"
FRASER: WAREHOUSE CLUBS WOULD BE CONSIDERED A RETAILER. AND WHETHER THEY HAVE TO REGISTER OR NOT DEPENDS ON WHETHER THE SALES TO CONSUMERS IS GREATER THAN THEIR SALES TO BUSINESSES. SO A RETAILER, AGAIN, WE DEFINE AS SALES TO CONSUMERS IS THEIR PRIMARY FUNCTION.
OKAY. LET ME THROW ANOTHER ONE AT YOU WHILE YOU'RE WARMED UP HERE.
FRASER: OKAY.
"ARE PROCESSORS WHO HAVE A SEPARATE KITCHEN FOOD MANUFACTURING FACILITY IN THEIR HOME REQUIRED TO REGISTER?"
FRASER: PRIVATE RESIDENCES ARE EXEMPT.
OKAY.
FRASER: SO, NO.
OKAY. HERE'S ONE WE GOT BEFORE THE BROADCAST. "ARE FACILITIES THAT MANUFACTURE AND/OR SELL SEED TO FARMERS REQUIRED TO REGISTER? DOES THIS INCLUDE SEED THAT HAS BEEN TREATED TO INCORPORATE A NUMBER OF INGREDIENTS? WHAT IF THE SEED IS FOR AN AGRICULTURAL PRODUCT ONLY? AND WHAT IF THE SEED IS AN INGREDIENT TO BE INCLUDED IN ANIMAL FEED?"
FRASER: THAT'S A^--
THAT'S ABOUT 12^QUESTIONS.
FRASER: RIGHT. THAT'S A COMPLICATED QUESTION. BASICALLY, IT DEPENDS ON WHAT THE SEED IS BEING USED FOR. IF THE SEED IS TO BE PLANTED INTO THE GROUND, THEN WE WOULD NOT COUNT THAT AS A FACILITY THAT IS MANUFACTURING, PROCESSING, PACKING OR HOLDING FOOD THAT WOULD REQUIRE REGISTRATION. IF THE SEED IS GOING TO BE INCORPORATED INTO ANIMAL FEED, THEN IT IS A COMPONENT OF FOOD OR A FOOD INGREDIENT, AND REGISTRATION WOULD BE REQUIRED FOR ANY OF THE FACILITIES THAT MANUFACTURE, PROCESS, PACKED OR HELD THAT SEED.
OKAY. RAY, THIS ONE IS ON REGISTRATION. IT SAYS, "IF MY COMPANY INITIALLY REGISTERS USING THE PAPER FORMS, WILL WE BE ABLE TO UPDATE OUR REGISTRATION IN THE FUTURE USING THE INTERNET?"
RUSSO: YES. WHAT THEY HAVE TO DO IS ESTABLISH AN ACCOUNT IN THE ELECTRONIC SYSTEM. WHEN PEOPLE REGISTER, THEY'RE ALSO GIVEN A P.I.N. NUMBER. AND THE PURPOSE OF THAT P.I.N. IS SO THAT, WHEN THEY DO GO INTO THE REGISTRATION SYSTEM, THEY CAN USE THE P.I.N. NUMBER AND THE REGISTRATION NUMBER AND LINK THEM TO THEIR ACCOUNT. SO, YES, USING THE P.I.N. NUMBER, THEY WOULD BE ABLE TO ACCESS THE REGISTRATION ELECTRONICALLY AND UPDATE IT.
HERE'S ONE THAT JUST CAME IN. IT SAYS, "WHAT IS THE U.S. AGENCY'S LIABILITY?" (*See errata)
LAKE: LET ME ANSWER THAT, TAKE A SHOT AT IT. WHEN I HEAR PEOPLE ASK ABOUT LIABILITY, I HEAR TWO DIFFERENT KINDS OF QUESTIONS. ONE IS REALLY, WHAT'S THEIR RESPONSIBILITY TO FDA? AND THAT, I THINK, AS WE DESCRIBED EARLIER, IS TO SERVE AS A COMMUNICATIONS LINK BETWEEN FDA AND THE FACILITY. THE OTHER QUESTION THAT I THINK PEOPLE ARE ASKING WHEN^-- BECAUSE (*See errata) WE'VE HEARD THIS QUESTION BEFORE, REALLY RELATES TO, WHAT IS THE LEGAL LIABILITY OF THE AGENT IN THE EVENT THAT SOMETHING GOES WRONG? AND THAT'S A MATTER OF THE LAW OF AGENCY AND IS RESOLVED BY COURTS. IT IS NOT A MATTER TO BE RESOLVED BY FDA. IT IS LARGELY DETERMINED BY THE ARRANGEMENTS THAT THE AGENT MAKES^-- OR THAT THE FACILITY MAKES WITH THE AGENT. SO, AGAIN, I THINK THAT FACILITIES DO NEED TO EXERCISE SOME CARE IN IDENTIFYING THE AGENT. BUT IF ANY LEGAL DISPUTES ARISE BETWEEN THE AGENT AND THE FACILITY, THOSE HAVE TO BE RESOLVED THROUGH THE NORMAL LEGAL PROCESSES, AND IS NOT A PART OF WHAT FDA DOES.
OKAY. LESLYE, THIS ONE SAYS, "IS IT NECESSARY FOR COTTON GINS TO REGISTER IF THEY SELL COTTONSEED AND/OR COTTONSEED HULLS TO A FEED MANUFACTURER WHO THEN FURTHER PROCESSES THESE ITEMS INTO FEED FOR SALE TO LIVESTOCK OPERATIONS?"
FRASER: YES, THEY DO HAVE TO REGISTER. THEY ARE MANUFACTURING AND PROCESSING A FOOD INGREDIENT. IN THIS CASE, IT'S AN INGREDIENT OF ANIMAL FEED.
OKAY, HERE'S ANOTHER ONE. "ARE TRANSLOADING LOCATIONS REQUIRED TO REGISTER IN SITUATIONS WHERE RAILCARS LOADED WITH COMMODITIES, LIKE SOYBEAN, MEAL, DISTILLER, GRAINS AND SO ON, ARRIVE AT LOCATIONS, ARE STORED FOR ONE OR MORE DAYS, AND THEN ARE UNLOADED FROM THE RAILCARS AND LOADED INTO TRUCKS FOR DELIVERY TO FARMERS?"
FRASER: YES, THEY DO. THEY ARE HOLDERS OF THE FOOD. AND YOU CAN THINK OF THEM AS A MASSIVE WAREHOUSE. THEY'RE SIMILAR TO THE TRANSPORTATION HUBS THAT TRUCKS WOULD COME INTO, BUT THEY DO HAVE TO REGISTER.
BOB, THIS ONE LOOKS LIKE IT'S FOR YOU. IT SAYS, "IF A FOREIGN FACILITY MANUFACTURES FOODS IN THREE PRODUCT CATEGORIES, BUT IT EXPORTS FOODS IN ONE PRODUCT CATEGORY TO THE U.S., MUST IT CHECK ALL THREE PRODUCT CATEGORIES ON THE REGISTRATION FORM?"
LAKE: ALL THAT WE CARE ABOUT IS THAT THE FOOD COMING TO THE U.S. IS COMING FROM A FACILITY THAT'S REGISTERED. SO ONLY THE ONE CATEGORY THAT IS COMING TO THE U.S. NEEDS TO BE^-- YOU (*See errata) KNOW, THAT'S A BASIS FOR REGISTRATION, AND THE ONLY CATEGORY THAT HAS (*See errata) TO BE CHECKED. OF COURSE, IF THAT CHANGES DOWN THE ROAD, THEN THE REGISTRATION WOULD HAVE TO BE UPDATED.
OKAY, ANOTHER ONE. "IF A FARM LABELS OR APPLIES INVENTORY CONTROL ITEMS, SUCH AS UNIVERSAL PRODUCT CODES TO FRESH PRODUCE, WILL THIS ACTIVITY CAUSE THE FARM TO LOSE ITS EXEMPTION?"
LAKE: NO, MARK. WE HAVE THE VIEW THAT, IF THAT'S ALL YOU'RE DOING, IS PUTTING A STICKER ON THE FRUIT WHILE IT'S STILL ON THE FARM, THAT THAT WE CONSIDER TO BE WITHIN THE PURVIEW OF FARMING ACTIVITY. AND SO THE FARM DOES NOT LOSE ITS EXEMPTION.
WELL, WE HAVE MORE QUESTIONS. AND I'M GOING TO STOP THIS PANEL NOW SO THAT WE HAVE ENOUGH TIME FOR THE NEXT PANEL TO DO ITS JOB AS WELL. AND SO WE'RE GOING TO GO NOW FOR A TEN-MINUTE BREAK. WHEN WE COME BACK, WE'RE GOING TO PROCEED TO THE SECOND PANEL ON PRIOR NOTICE. DURING THE BREAK, WE'LL BE SHOWING SOME IMPORTANT INFORMATION ON YOUR SCREEN, INCLUDING THE ELECTRONIC AND MAIL ADDRESSES THAT YOU SHOULD USE TO SUBMIT YOUR COMMENTS TO THE DOCKET'S MANAGERS' BRANCH. IF YOU SEND COMMENTS, PLEASE REMEMBER TO ADDRESS THOSE SPECIFIC AREAS FOR WHICH COMMENT WAS REQUESTED IN THE INTERIM FINAL RULE. ALSO REMEMBER THAT, DURING THE BREAK, YOU'LL BE SEEING THE INTERNET ADDRESS FOR FDA'S BIOTERRORISM WEBPAGE. AND ON THAT WEBPAGE, YOU'LL FIND A LINK TO ALL OF THE INFORMATIONAL MATERIALS DEVELOPED BY THE FDA ON THE INTERIM FINAL RULES, YOU'LL FIND UPDATED INFORMATION ON FUTURE SATELLITE DOWNLINKS AND A WIDE VARIETY OF TOPICS ON FDA'S ACTIVITIES INVOLVING BIOTERRORISM. SO COME BACK, WE'LL SEE YOU BACK HERE IN TEN MINUTES.
OKAY, WE'RE BACK LIVE NOW AND READY FOR OUR SECOND PANEL TO DISCUSS THE PROPOSED REGULATION ON PRIOR NOTICE OF IMPORTED FOOD. REMEMBER, THIS REGULATION FOCUSES ON ALL FDA-REGULATED FOOD AND FEEDS. THIS REGULATION REQUIRES FDA TO RECEIVE ADVANCE NOTICE OF ANY FOOD OR IMPORTED OR OFFERED FOR IMPORT INTO THE U.S., SO THIS PANEL IS GOING TO BE OF PARTICULAR INTEREST TO EXPORTERS, IMPORTERS, BROKERS AND ANYONE ASSOCIATED WITH IMPORTED FOOD. LET ME INTRODUCE OUR PANELISTS AT THIS TIME. DEBBIE RALSTON IS DIRECTOR OF THE OFFICE OF REGIONAL OPERATIONS IN FDA'S OFFICE OF REGULATORY AFFAIRS. GEORGE BRUSH IS PROJECT OFFICER IN THE OFFICE OF INFORMATION TECHNOLOGY IN FDA'S OFFICE OF REGULATORY AFFAIRS. LESLYE FRASER IS RETURNING TO JOIN US FOR THIS SECOND PANEL. SHE'S ASSOCIATE DIRECTOR FOR REGULATIONS AT FDA'S CENTER FOR FOOD SAFETY AND APPLIED NUTRITION. AND WE'RE ALSO PLEASED TO WELCOME CATHY SAUCEDAA, WHO'S DIRECTOR, SPECIAL ENFORCEMENT, OFFICE OF FIELD OPERATIONS, CUSTOMS AND BORDER PROTECTION. WELL, LESLYE, LET'S BEGIN BY JUST SIMPLY TALKING ABOUT WHAT PRIOR NOTICE IS.
FRASER: PRIOR NOTICE IS A NEW STATATORY REQUIREMENT IN THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002, WHICH WE CALL THE BIOTERRORISM ACT, THAT BEGINNING DECEMBER^12th OF THIS YEAR, REQUIRES FDA TO RECEIVE ADVANCE NOTICE OF ANY FOOD THAT IS BEING IMPORTED OR OFFERED FOR IMPORT INTO THE UNITED^STATES BEFORE THE FOOD ACTUALLY ARRIVES HERE.
NOW, THE FIRST PANEL, TALKING ABOUT REGISTRATION. DISTINGUISH BETWEEN REGISTRATION AND PRIOR NOTICE.
FRASER: THERE ARE A COUPLE DIFFERENCES, MARK. FIRST, REGISTRATION APPLIES TO FACILITIES, AND IT APPLYING ONLY TO FOOD THAT WILL BE CONSUMED IN THE U.S., AND IT ONLY APPLIES TO FACILITIES THAT MANUFACTURE, PROCESS, PACK OR HOLD THAT FOOD. BY COMPARISON, PRIOR NOTICE APPLIES TO ALL FOOD UNDER OUR JURISDICTION UNLESS IT'S OTHERWISE EXEMPTED IN THE RULE FOR WHATEVER REASON THAT IT COMES INTO THE U.S., AND WHETHER OR NOT THAT FOOD ORIGINATES FROM A FACILITY THAT WAS REQUIRED TO REGISTER WITH FDA OR NOT.
NOW, FDA DOES ALREADY COLLECT SOME INFORMATION ON FOOD SHIPMENTS. DISTINGUISH BETWEEN THAT INFORMATION AND WHAT'S GOING TO BE REQUIRED UNDER PRIOR NOTICE.
FRASER: PRIOR NOTICE IS A NEW REQUIREMENT AND IT DOES NOT REPLACE WHAT WE CURRENTLY DO. CURRENTLY WHEN FOOD IS IMPORTED OR OFFERED FOR IMPORT INTO THE UNITED^STATES, FILERS^-- WHAT THEY CALL FILE ENTRY WITH CUSTOMS AND BORDER PROTECTION, AND THEY CAN DO THAT UP TO 15^DAYS AFTER THE FOOD FIRST ARRIVES HERE. ONCE THEY MAKE THAT FILING, THEN FDA GETS NOTICE THROUGH THE AUTOMATED BROKER INTERFACE, AND WE MAKE DECISIONS ABOUT WHETHER TO ADMIT THAT FOOD UNDER OUR EXISTING AUTHORITY, AND SOME OF THE THINGS THAT WE LOOK AT IS WHETHER THE FOOD APPEARS ADULTERATED, WHICH IS ANOTHER WORD FOR CONTAMINATION, OR MISBRANDED. PRIOR NOTICE IS AN ADDITIONAL REQUIREMENT, AND IT REALLY IS GIVING US INFORMATION THAT WE CURRENTLY GET AT ENTRY, BUT EARLIER IN THE PROCESS. WE NOW WOULD GET THAT INFORMATION SOONER. WE CAN DECIDE WHAT FOOD WE WANT TO INSPECT SOONER, AND IN PARTICULAR WE CAN DECIDE IF THERE'S ANY FOOD FOR WHICH WE HAVE A PARTICULAR PUBLIC HEALTH CONCERN AND STOP THAT FOOD WHEN IT FIRST ARRIVES IN THE UNITED^STATES AND DETERMINE WHETHER INSPECTION IS APPROPRIATE FOR THAT.
I ASSUME YOU CAN CROSS-MATCH THE DATA YOU GET FROM THE OLDER SYSTEM WITH PRIOR NOTICE?
FRASER: YES, WE CAN, AND AS GEORGE AND CATHY WILL BE TALKING ABOUT IN A BIT, THE PRIOR NOTICE INFORMATION WILL BE MATCHED UP WITH THE INFORMATION THAT CUSTOMS NEEDS FOR THEIR PURPOSES.
DEBBIE, WHY IS IT IMPORTANT THAT THE FDA RECEIVE THIS NOTICE AS SOON AS LESLYE WAS TALKING ABOUT.
RALSTON: WE BELIEVE THAT THE INTERIM FINAL RULE WILL RESULT IN A SIGNIFICANT IMPROVEMENT IN OUR ABILITY TO DETECT AND DETER, PREPARE FOR, AND ULTIMATELY TO EFFECTIVELY RESPOND TO ANY (*See errata) BIOTERRORISM TYPE EVENTS, OR ANY SERIOUS ADVERSE HEALTH CONSEQUENCE EVENTS THAT MAY RESULT FROM THE IMPORTATION OF A FOOD PRODUCT.
HOW DOES THIS INFORMATION UNDER PRIOR NOTICE DIFFER FROM WHAT'S ALREADY BEING PROVIDED, LETS SAY, THROUGH CUSTOMS?
RALSTON: MOST OF THE INFORMATION THAT'S REQUIRED UNDER THE PRIOR NOTICE REGULATION IS ALREADY SUBMITTED TO CUSTOMS AND BORDER PROTECTION AS IMPORT ENTRY DATA. THE KEY DIFFERENCE IN THIS NOW IS THE TIMING DURING WHICH THAT (*See errata) SUBMISSION OCCURS. RIGHT NOW THAT KIND OF DATA IS SUBMITTED TO CBP AS LATE AS 15 DAYS AFTER THE ACTUAL PRODUCTS ENTER THE UNITED STATES. PRIOR NOTICE IS GOING TO REQUIRE THAT THAT INFORMATION COME INTO THE AGENCY PRIOR TO THE PRODUCT BEING OFFERED FOR ENTRY INTO THE U.S. (*See errata) THAT'S REALLY GOING TO HELP THE AGENCY, BECAUSE WE'RE GOING TO HAVE THE ABILITY TO REVIEW THIS INFORMATION IN ADVANCE, MAKE DECISIONS AS TO WHETHER OR NOT WE WANT TO HOLD IT TO EXAMINE IT, TO SAMPLE IT, JUST TO ASSURE THAT SUSPECT PRODUCT REALLY IS ABLE TO BE HANDLED BY THE AGENCY IN A TIMELY FASHION.
LESLYE, LET'S GET BACK TO TALKING ABOUT FARMS, WHICH WE TALKED ABOUT DURING THE FIRST PANEL. IN THE FIRST PANEL, YOU SAID FARMS ARE NOT REQUIRED TO REGISTER WITH THE FDA, AT LEAST UNTIL CERTAIN CONDITIONS. WHAT ABOUT PRIOR NOTICE? ARE FARMS REQUIRED TO DO PRIOR NOTICE?
FRASER: IT'S NOT NECESSARILY THE FARMS THAT HAVE TO DO THE PRIOR NOTICE, BUT FDA HAS TO RECEIVE PRIOR NOTICE OF ALL FOOD PRODUCTS, EVEN FOOD COMING FROM A FARM THAT CROSSES OUR BORDER FOR ANY REASON. SO AGAIN, IT'S NOT TIED TO THE SOURCE OF THE FOOD, IT'S TIED TO THE FACT THAT THE FOOD IS COMING INTO THIS COUNTRY, IT IS BEING IMPORTED OR OFFERED FOR IMPORT, AND SOMEONE WITH KNOWLEDGE OF THAT INFORMATION MUST PROVIDE IT TO FDA.
SO SOMEONE WOULD HAVE TO SUBMIT PRIOR NOTICE UNDER THIS REGULATION AND STILL BUT BE EXEMPT FROM THE REGISTRATION REQUIREMENT?
FRASER: ABSOLUTELY.
OKAY.
FRASER: AND WHAT'S IMPORTANT IS THAT PEOPLE LOOK AT BOTH RULES SEPERATELY AND DETERMINE WHETHER THEY ARE SUBJECT TO ONE, BOTH, OR NONE.
WHO'S AUTHORIZED TO SUBMIT PRIOR NOTICE?
FRASER: IN THE INTERIM FINAL RULE, WE AUTHORIZE ANYONE TO SUMBIT THE PRIOR NOTICE WHO HAS KNOWLEDGE OF THE INFORMATION THAT DEBBIE WILL TALK ABOUT SHORTLY.
OKAY. NOW, LET'S TALK A LITTLE BIT ABOUT THE FOODS THAT ARE SUBJECT TO PRIOR NOTICE.
FRASER: AGAIN, WE START WITH THE FOOD THAT IS UNDER OUR JURISDICTION, SO WE START WITH THE FEDERAL FOOD DRUG AND COSMETIC ACT. AND AS WE DID IN REGISTRATION, THAT IS THE BEGINNING, THEN WE HAVE SOME EXEMPTIONS AFTER THAT. BUT THAT BASICALLY IS FOOD THAT IS USED FOR MAN OR ANIMALS, CHEWING GUM, OR COMPONENTS OF THAT FOOD. WE ALSO INCLUDE THE TYPES OF FOOD THAT IS INCLUDED IN THAT, AND THAT WOULD BE DIETARY SUPPLEMENTS AND DIETARY INGREDIENTS, INFANT FORMULA, BEVERAGES, FRUITS AND VEGETABLES, FISH AND SEAFOOD, DAIRY PRODUCTS AND SHELL EGGS, RAW AGRICULTURAL COMMODITIES FOR USE AS FOOD OR COMPONENTS OF FOOD, CANNED AND FROZEN FOOD, LIVE FOOD ANIMALS, BAKERY GOODS, SNACK FOOD, CANDY, AND CHEWING GUM, AND ANIMAL FEEDS AND PET FOOD. I THINK THE PEOPLE WHO ARE DOING THE SLIDES WERE BETTER THAN I WAS. I KIND OF SKIPPED OVER JUST SOME MORE CLARIFICATION ON THE TYPES OF FOOD THAT ARE SUBJECT TO PRIOR NOTICE, AND IN TERMS OF CATEGORIES, IT DOES INCLUDE GIFTS, TRADE SAMPLES, QUALITY ASSURANCE, AND QUALITY CONTROL SAMPLES, FOOD FOR FUTURE EXPORT, AS WELL AS FOOD THAT IS TRANSSHIPPED THROUGH THE UNITED^STATES. AND WHAT WE MEAN BY THAT IS FOOD THAT COMES IN AT ONE PORT, TRAVELS THROUGH THE UNITED^STATES, PERHAPS BY TRUCK, AND THEN IS EXPORTED FROM ANOTHER PORT. FOOD FOR USE IN A FOREIGN TRADE ZONE, FOODS SENT BY INTERNATIONAL MAIL SERVICES, AS WELL AS FOOD SENT BY EXPRESS COURIER, SUCH AS FedEx, UPS OR DHL. AGAIN ALL FOOD CROSSING OUR BORDER IS SUBJECT TO PRIOR NOTICE UNLESS WE HAVE EXEMPTED IT.
GIVE SOME EXAMPLE FDA-REGULATED FOODS THAT ARE GONNA REQUIRE PRIOR NOTICE.
FRASER: THOSE ARE THE ONES WE JUST BRIEFLY WENT THROUGH THAT FROM THE DIETARY SUPPLEMENTS TO THE ANIMAL FEEDS, BUT GENERALLY IT IS FOOD UNDER OUR JURISDICTION. THEN ON THE NEXT SLIDES THAT ARE SHOWING NOW, WE DO TALK ABOUT THE FOOD THAT IS EXCLUDED IN THE INTERIM FINAL RULE, AND THAT INCLUDES FOOD CONTACT SUBSTANCES, PESTICIDES REGULATED BY THE ENVIRONMENTAL PROTECTION AGENCY, THOSE ARE THE SAME EXEMPTIONS THAT WE HAD IN REGISTRATION. SO ANY OF THESE THAT ARE HANDLING FOOD CONTACT SUBSTANCES WHICH DOES INCLUDE PACKAGING AND ENTITIES HANDLING PESTICIDES ARE EXEMPT FROM BOTH REGISTRATION AND PRIOR NOTICE. AND ALSO EXEMPTED FROM PRIOR NOTICE, LIKE THEY ARE FOR REGISTRATION ARE MEAT PRODUCTS, POULTRY PRODUCTS AND EGG PRODUCTS. HERE THEY'RE EXEMPTED FROM PRIOR NOTICE IF AT THE TIME OF IMPORTATION THEY ARE UNDER THE EXCLUSIVE JURISDICTION OF THE U.S.^-- UNITED STATES DEPARTMENT OF AGRICULTURE. WE ALSO HAVE ONE MORE EXEMPTION FOR FOOD THAT IS CARRIED OR OTHERWISE BROUGHT WITH A TRAVELER WHEN THEY COME INTO THIS COUNTRY, PROVIDED THAT THE FOOD IS FOR THEIR OWN PERSONAL USE. AND BY PERSONAL USE WE MEAN THEMSELVES, THEIR FAMILIES OR THEIR FRIENDS. IF A TRAVELER IS BRINGING IN FOOD FOR BUSINESS PURPOSES, THEN PRIOR NOTICE WOULD BE REQUIRED.
LET ME GIVE YOU AN EXAMPLE, ASK YOU ABOUT AN EXAMPLE, LET'S SAY APPLES ARE TRANSPORTED FROM CANADA, THE DESTINATION IS MEXICO, THEY GO THROUGH THE U.S., BUT THERE'S NO U.S. IMPORTER, THERE'S NO U.S.^PURCHASER. IS PRIOR NOTICE GONNA BE REQUIRED?
FRASER: YES, PRIOR NOTICE IS REQUIRED. THIS IS A GOOD EXAMPLE OF A DISTINCTION BETWEEN REGISTRATION AND PRIOR NOTICE. REGISTRATION WOULD NOT BE REQUIRED, BECAUSE THE FOOD IS NOT GOING TO BE CONSUMED IN THE UNITED^STATES, IN YOUR EXAMPLE IT WAS INTENDED FOR MEXICO. BUT PRIOR NOTICE IS REQUIRED, BECAUSE THE FOOD IS COMING INTO OUR COUNTRY, IT IS TRAVELING THROUGH OUR COUNTRY. AND THE REASON WE REQUIRE PRIOR NOTICE IS IF THERE IS A HEALTH RISK ASSOCIATED WITH THAT PRODUCT, WE WANT TO KNOW ABOUT IT BEFORE IT COMES INTO THE COUNTRY AND POSSIBLY COULD BE DIVERTED.
LET ME GIVE YOU ANOTHER EXAMPLE. SUPPOSE I IMPORT BANANAS AND PINEAPPLES, THEY'RE SHIPPED ON THE SAME TRUCK, THERE IS THERE ONE PRIOR NOTICE OR TWO PRIOR NOTICES ONE FOR EACH OF THE TWO FRUITS?
FRASER: PRIOR NOTICE IS TIED TO AN ARTICLE OF FOOD, WHICH IS SIMILAR TO WHAT IS CONSIDERED A LINE ENTRY FOR CUSTOMS AND BORDER PROTECTION PURPOSES. SO SINCE THESE ARE DIFFERENT FOOD PRODUCTS, THEY WOULD REQUIRE DIFFERENT LINE ENTRIES, AND CORRESPONDINGLY, THEY REQUIRE DIFFERENT PRIOR NOTICES.
NOW, WE JUST TALKED ABOUT TWO DIFFERENT KINDS OF FOOD, BANANAS AND PINEAPPLE. LET'S TAKE ONE KIND OF FOOD, LET'S SAY CANNED TUNA FISH. LET'S SAY IT'S ONE SHIPMENT IS ON THE SAME TRUCK, BUT THE CANNED TUNA COMES FROM THREE DIFFERENT MANUFACTURERS. IS THAT ONE PRIOR NOTICE OR THREE PRIOR NOTICES?
FRASER: THAT WOULD BE THREE PRIOR NOTICES, BECAUSE YOU DO HAVE THREE DIFFERENT MANUFACTURERS, AND AS THE SLIDE THAT'S SHOWING NOW IS TRYING TO DISTINGUISH BETWEEN AN ARTICLE OF FOOD AND A SHIPMENT OF FOOD. SO WE KNOW THAT IN A SHIPMENT OF FOOD, SUCH AS ONE THAT COMES IN BY TRUCK, THERE ARE MANY DIFFERENT FOOD PRODUCTS, BUT EVEN IN YOUR EXAMPLE WHERE YOU HAVE DIFFERENT KINDS OF TUNA, BECAUSE YOU HAVE THREE DIFFERENT MANUFACTURERS, THE PRODUCT IDENTITY IS DIFFERENT. AND IF THEY WERE PACKAGED DIFFERENTLY, AS IS SHOWN ON THIS (*See errata) CHART, YOU HAVE^-- MAYBE YOU HAVE 24-OUNCE CANS, 12-OUNCE CANS AND ALSO 6-OUNCE CANS WHERE THEY ARE PACKAGED DIFFERENTLY, THOSE WOULD ALSO BE DIFFERENT PRODUCT IDENTITIES. EACH OF THOSE WOULD REQUIRE A DIFFERENT LINE ENTRY WITH CUSTOMS, AND EACH OF THOSE WOULD REQUIRE A DIFFERENT PRIOR NOTICE WITH FDA.
DEBBIE, TALK ABOUT WHAT KIND OF INFORMATION HAS TO BE INCLUDED WITH PRIOR NOTICE.
RALSTON: WELL, AS I PREVIOUSLY INDICATED, MOST OF THE DATA IS TYPICALLY SUBMITTED TO CUSTOMS AND BORDER PROTECTION AS PRODUCT ENTRY DATA, SO MOST OF THIS IS NOT NEW DATA FOR FOLKS WHO WILL BE IMPORTING PRODUCTS THROUGH CUSTOMS AND BORDER PROTECTION. THE SPECIFIC DATA ELEMENTS ARE DEPICTED ON THIS AND THE NEXT SEVERAL SLIDES. THE FIRST OF THEM IS SUBMITTER, NAME, ADDRESS, PHONE, FAX, AND E-MAIL. TRANSMITTER, NAME, ADDRESS, PHONE, FAX AND E-MAIL. THE CUSTOMS AND BORDER PROTECTION ENTRY TIME. (*See errata) THAT COULD BE A CONSUMPTION ENTRY, WAREHOUSE, TRANSPORTATION AND EXPORTATION ENTRY. CBP ENTRY IDENTIFIER, ENTRY NUMBER OR IN-BOND NUMBER. THE IDENTITY OF THE ARTICLE OF FOOD, COMPLETE FDA PRODUCT CODE, COMMON OR USUAL NAME OR MARKET NAME, ESTIMATED QUANTITY, LOT OR CODE NUMBERS IF REQUIRED BY THE FOOD, DRUG AND COSMETIC ACT OR FDA REGULATIONS. EXAMPLES OF THOSE KINDS OF PRODUCTS FOR WHICH LOT OR CODE NUMBERS ARE REQUIRED ARE LOW-ACID CANNED FOODS, INFANT FORMULA AND ACIDIFIED FOODS. FOOD FOR WHICH^-- FOR FOOD NO LONGER IN ITS NATURAL STATE, MANUFACTURER AND REGISTRATION NUMBER IS REQUIRED. FOR FOOD IN ITS NATURAL STATE, GROWER, IF KNOWN. FDA COUNTRY OF PRODUCTION, SHIPPER AND REGISTRATION NUMBER, COUNTRY FROM WHICH THE ARTICLE IS SHIPPED, ANTICIPATED ARRIVAL INFORMATION, WHICH INCLUDES PORT OF ARRIVAL, WHICH INCLUDES ALSO THE BORDER CROSSING, THE DATE OF THE ARRIVAL AND THE TIME OF THE ARRIVAL. NAME AND ADDRESS OF THE IMPORTER, NAME AND ADDRESS OF OWNER, IF THAT'S DIFFERENT THAN THE IMPORTER OR THE ULTIMATE CONSIGNEE. AND NAME AND ADDRESS OF THE ULTIMATE CONSIGNEE. THE MODE OF TRANSPORTATION IS ALSO REQUIRED. THE CARRIER, THE STANDARD CARRIER ABBREVIATION CODE, AND/OR^--^AND THE INTERNATIONAL^-- EXCUSE ME^-- AND/OR THE INTERNATIONAL AIR TRANSPORTATION ASSOCIATION CODE FOR THE CARRIER THAT CARRIES THE FOOD FROM THE COUNTRY FROM WHICH IT IS SHIPPED, THE HARMONIZED TARIFF SCHEDULE CODE^-- THAT'S ALSO KNOWN AS THE HTS CODE, AND FINALLY THE PLANNED SHIPMENT INFORMATION. FOR MODES OF TRANSPORTATION INVOLVING THE AIRWAY BILL NUMBER OR BILL OF LADING NUMBER AND CONTAINER NUMBER IF CONTAINERIZED CARGO. FOR THE VESSELS, IT'S VESSEL NAME AND VOYAGE NUMBER. FOR AIR IT'S FLIGHT NUMBER. FOR ROAD, IT'S TRIP NUMBER. FOR CAR IT'S^-- FOR RAIL IT'S CAR NUMBER, AND FOR PRIVATE (*See errata) VEHICLES, THE LICENSE PLATE NUMBER AND THE STATE AND PROVINCE IN WHICH THE CAR IS LICENSED.
DEBBIE, TALK A LITTLE BIT ABOUT THE TIMING FOR THIS. WHEN DOES THIS HAVE TO BE SUBMITTED IN RELATION TO WHEN THE SHIPMENT TAKES PLACE?
RALSTON: WELL, THE TIMING DEPENDS UPON THE MODE OF TRANSPORT. PRIOR NOTICE MUST BE SUBMITTED NO MORE THAN FIVE DAYS BEFORE ARRIVAL AND NO FEWER THAN TWO HOURS IF BY LAND VIA ROAD, FOUR HOURS IF BY AIR OR LAND VIA RAIL, AND EIGHT HOURS IF BY WATER.
NOW, SUPPOSE THIS ISN'T AN ACTUAL SHIPMENT, SUPPOSE A PERSON IS CARRYING THIS MATERIAL ON THEIR PERSON, THEN WHAT ABOUT THE TIMING?
RALSTON:: ASSUMING IT'S A SHIPMENT THAT'S DESTINED FOR PERSONAL CONSUMPTION AS LESLYE DESCRIBED, THE TIME FRAME THAT APPLIES TO THAT PARTICULAR FOOD IS THE TIME FRAME THAT APPLIED TO THE MODE OF TRANSPORT BY WHICH THE PERSON ENTERED THE UNITED STATES. FOR EXAMPLE, SOMEONE EITHER DRIVES IN FROM CANADA OR FROM MEXICO BY CAR. THE TIME FRAME PERTINENT TO THAT PARTICULAR ENTRY OF FOOD WOULD BE A TWO-HOUR TIME FRAME.
AND WHAT^--
FRASER: : AND, MARK, IF I COULD JUST CLARIFY, THAT'S IF IT'S FOR BUSINESS REASON. FOR PERSONAL USE, IT WOULD NOT REQUIRE PRIOR NOTICE.
OKAY, WHAT ABOUT INTERNATIONAL MAIL?
RALSTON: FOR FOOD THAT'S SENT BY INTERNATIONAL MAIL, THE PRIOR NOTICE MUST BE SUBMITTED AND CONFIRMED BEFORE THE PACKAGE IS ACTUALLY MAILED INTO THE UNITED^STATES. GIVEN THE NUANCES OF INTERNATIONAL MAIL, THIS IS THE ONLY CIRCUMSTANCE IN WHICH THE PRIOR NOTICE CAN BE SUBMITTED MORE THAN FIVE DAYS IN ADVANCE OF THE PACKAGE'S ARRIVAL INTO THE UNITED^STATES. THE FDA CONFIRMATION MUST ACCOMPANY THE PARCEL WHEN IT ARRIVES IN THE^U.S.
CATHY, HOW IS PRIOR NOTICE SUBMITTED?
SAUCEDA: WELL, THERE'S SEVERAL WAYS TO SUBMIT PRIOR NOTICE. I'M GOING TO TALK ABOUT THOSE THAT ARE RELATED TO OUR AUTOMATED COMMERCIAL SYSTEM, OR ACS. AND I THINK GEORGE IS GOING TO TALK ABOUT SOME OF THE OTHER WAYS. THROUGH OUR AUTOMATED COMMERCIAL SYSTEM, ACS, FOR CONSUMPTION ENTRIES AND WAREHOUSE ENTRIES THAT ARE FILED IN AN AUTOMATED FASHION BY OUR AUTOMATED BROKER INTERFACE, OR ABI, THE PRIOR NOTICE INFORMATION AND THE ENTRY INFORMATION WILL TRAVEL TOGETHER WITH A CERTAIN SWITCH BEING MADE AND THE PRIOR NOTICE INFORMATION WILL GO TO THE FOOD & DRUG ADMINISTRATION, AND THEN THERE WILL BE A RESPONSE BACK, AND THEN WE WILL SEND THE INFORMATION ON TO THE FILER. FOR THOSE TYPES OF ENTRIES LIKE SOME OF OUR IN-BOND ENTRIES AND FTZs THEY'RE AUTOMATED, AND WE'RE DEVELOPING A SPECIAL SYSTEM WHICH WE'RE CALLING EITHER A MINI-ABI OR INTERMEDIATE STEP. AND THE PRIOR NOTICE INFORMATION WILL BE FILED, AND IT WILL^-- THROUGH A NEW^-- THIS NEW PROGRAM, AND IT WILL BE MATCHED UP TO OUR ABI TRANSMISSION. SO IT WILL LOOK TO US AS IF IT'S COMPLETELY AUTOMATED, BUT IT WILL BE SOMETHING THAT'S NEW AND THAT WILL BE OUT THERE AT SOMETIME SOON, SO THAT THIS CAN BE FURTHER DEVELOPED BY THE TRADE COMMUNITY.
GEORGE, ANYTHING TO ADD FOR FDA?
BRUSH: YEAH. IF YOU'RE NOT GOING TO USE A BROKER, THAT IS IF YOU PREFER TO FILE ON YOUR OWN, OR FOR THOSE SUBMISSIONS THAT CANNOT BE FILED THROUGH CBP^ACS, LIKE FOODS ENTERING THROUGH FOREIGN MAIL SYSTEMS, THE FDA HAS CREATED THE PRIOR NOTICE SYSTEM INTERFACE. THIS SYSTEM WILL BE AVAILABLE TO ANY USER THAT HAS TO PROVIDE PRIOR NOTICE (*See errata) SYSTEM. (*See errata) BOTH OF THE SYSTEMS WILL BE AVAILABLE 24^HOURS A DAY, 7^DAYS A WEEK BEGINNING ON DECEMBER^12th OF THIS YEAR.
CATHY YOU TALKED ABOUT ABI, WHAT ARE THE INSTRUCTIONS FOR THOSE GOING TO BE UPDATED TO ACCOMMODATE PRIOR NOTICE?
SAUCEDA: OKAY, THE INSTRUCTIONS AND THE CATAIR WILL BE COMING WITHIN THE NEXT FEW WEEKS.
THE CATAIR IS YOUR NAME FOR^--
SAUCEDA: YES, THAT'S WHAT WE CALL IT.
RIGHT.
SAUCEDA: BUT WE HAVE POSTED NOW TO OUR AUTOMATIVE BROKER INTERFACER, ABI BROKER BULLETIN BOARD WHAT THEY NEED TO KNOW NOW TO START DEVELOPING THEIR SYSTEMS, MAKING CHANGES. I THINK THERE WAS A POSTING YESTERDAY OR THE DAY BEFORE, THERE COULD BE ONE TODAY, OR MAYBE IT WAS FILED YESTERDAY. THAT'S THE WAY, UNTIL WE ACTUALLY UPDATE THE CATAIR, AND POST IT ELECTRONICALLY, WE'LL BE USING THE ABI MESSAGE SYSTEM FOR THESE MESSAGES.
OKAY. GEORGE, WE SAID IN THE PRIOR PANEL THAT WITH REGISTRATION, YOU WOULD PREFER TO HAVE IT ELECTRONICALLY, BUT YOU COULD USE PAPER IF NECESSARY. NOW, FOR PRIOR NOTICE, ARE YOU GOING TO REQUIRE ELECTRONIC SUBMISSION?
BRUSH: YES, MARK. UNLIKE REGISTRATION, ELECTRONIC FILING IS REQUIRED FOR PRIOR NOTICE.
OKAY, SO THE QUESTION THEN GETS, HOW CAN I SUBMIT PRIOR NOTICE IF THE ELECTRONIC SYSTEM ISN'T WORKING?
BRUSH: WELL, THERE'S THREE OR FOUR DIFFERENT SCENARIOS HERE. IF CBP'S ACS SYSTEM IS NOT WORKING, THEN PRIOR NOTICE MUST BE SUBMITTED THROUGH THE PRIOR NOTICE SYSTEM INTERFACE. IF FDA'S PRIOR NOTICE SYSTEM INTERFACE OR THE FDA'S OASIS SYSTEM IS NOT WORKING, THEN THE REQUIRED INFORMATION MUST BE SUBMITTED BY FAX OR E-MAIL TO THE PRIOR NOTICE CONTACT NUMBERS AND ADDRESSES POSTED ON FDA'S WEBSITE.
CATHY, WHAT'S THE DIFFERENCE BETWEEN A PRIOR NOTICE THAT'S SUBMITTED TO CUSTOM'S ACS SYSTEM, AUTOMATED COMMERCIAL SYSTEM, AND ONE THAT'S SUBMITTED TO THE FDA'S PRIOR NOTICE SYSTEM?
SAUCEDA: WELL, THERE'S NO ACTUAL DIFFERENCE IN THE PRIOR NOTICE ITSELF. IT'S STILL THE SAME INFORMATION. IT'S THAT THE INFORMATION THAT'S SUBMITTED THROUGH OUR ACS SYSTEM IS AUTOMATICALLY MATCHED UP TO THE ENTRY DOCUMENTATION. SO OUR CUSTOMS AND BORDER PROTECTION OFFICIALS ARE GOING TO KNOW IMMEDIATELY WHAT THE DISPOSITION OF THIS BIOTERRORISM-RELATED GOOD IS. WHEREAS IF PRIOR NOTICE IS SUBMITTED THROUGH THE WEB PORTAL, THROUGH THE FDA WEB PORTAL, THEN IT DOESN'T AUTOMATICALLY MATCH UP TO OUR INTRADOCUMENTATION, SO IT'S GOING TO BE MORE OF A MANUAL PROCESS FOR OUR CBP OFFICERS TO DETERMINE WHETHER OR NOT THAT GOOD, THAT ARTICLE HAS SATISFIED THE PRIOR NOTICE REQUIREMENTS.
GEORGE, IT'S GOING TO TAKE SOME TIME I THINK FOR PEOPLE TO LEARN HOW TO USE THAT AUTOMATED SYSTEM. IS THERE A TUTORIAL OR A WAY THEY CAN FIND OUT?
BRUSH: WELL, HOPEFULLY, IT WON'T TAKE TOO LONG, MARK. WE HAVE EVERY CONFIDENCE THAT WE HAVE BUILT A GOOD PRODUCT. BUT A TUTORIAL FOR USING THE PRIOR NOTICE SYSTEM INTERFACE WILL BE POSTED ON THE FDA WEBSITE AT^-- WWW.FDA.GOV. AND CLICK ON "BIOTERRORISM."
NOW, IF I SUBMIT A PRIOR NOTICE, HOW DO I KNOW THAT YOU HAVE RECEIVED IT.
BRUSH: WELL, BOTH FDA'S PRIOR NOTICE SYSTEM INTERFACE AND CBP'S ACS SYSTEM WILL ISSUE A CONFIRMATION NUMBER. THIS CONFIRMATION NUMBER ASSURES THE USER THAT THE PRIOR NOTICE HAS BEEN RECEIVED AND THAT IT'S PASSED AN INITIAL VALIDATION.
HOW DO I KNOW IF IT'S NOT BEEN ACCEPTED?
BRUSH: WELL, IF YOU HAVEN'T RECEIVED THE CONFIRMATION NUMBER, THEN THE FDA DOES NOT HAVE THAT PRIOR NOTICE.
OKAY, IF I GET THE NUMBER, DOES THAT TELL ME THAT THE SUBMISSION THEN IS ADEQUATE, AS FAR AS YOU'RE CONCERNED?
BRUSH: NO. NO, NOT NECESSARILY. THE SYSTEM WILL NOT TRANSMIT A DECISION ABOUT THE PRIOR NOTICE. THE SYSTEM ONLY ACKNOWLEDGES THAT THE PRIOR NOTICE HAS BEEN RECEIVED.
WHAT ABOUT THE ONLINE HELP?
BRUSH: UP ON THE SCREEN, THERE'S LOTS OF ONLINE HELP. IT DEPENDS ON HOW YOU'RE SUBMITTING YOUR PRIOR NOTICE. BUT IF YOU'VE SUBMITTED THROUGH CBP'S ACS SYSTEM, THEN YOU NEED TO CALL YOUR CBP ABI CLIENT REP. AND FOR THOSE PEOPLE WHO FILE THROUGH ABI, THEY KNOW WHO THESE PEOPLE ARE. FOR ASSISTANCE WITH SUBMISSION THROUGH THE FDA'S PRIOR NOTICE SYSTEM INTERFACE, YOU WOULD CALL
1-800-216-7331^OR 301-575-0156. OR YOU CAN SEND US A FAX AT
301-210-0247. OR YOU CAN E-MAIL US QUESTIONS AT
FURLS@FDA.GOV.
CATHY, I WANT TO GO BACK TO THE CANNED TUNA EXAMPLE THAT I USED WITH LESLYE. THREE DIFFERENT MANUFACTURERS, SAME PRODUCT. WOULD I HAVE TO REENTER THE IDENTICAL INFORMATION FOR EACH ONE OF THE PRIOR NOTICES I SENT IN?
SAUCEDA: NOT NECESSARILY. THE ABI FILER, OR THE AUTOMATED BROKER INTERFACE FILER, WILL BE ABLE WHEN THEY MAKE CHANGES TO THEIR SYSTEM, TO PROGRAM IT SUCH THAT IT WILL SAVE THE INFORMATION THAT'S THE SAME IN EACH ONE OF THE PRIOR NOTICE FILINGS. SO THEY SHOULD ONLY HAVE TO INPUT THE CHANGES.
OKAY. AND, GEORGE, DO YOU HAVE ANYTHING TO ADD ON THAT?
BRUSH: WELL, FDA'S PRIOR NOTICE INTERFACE PROVIDES A GOOD DEAL OF ONLINE SUPPORT FOR USERS THAT WANT TO SUBMIT SEVERAL DIFFERENT PRODUCTS WITHIN A SHIPMENT. USERS WILL BE ABLE TO COPY A PREVIOUS PRIOR NOTICE AND THEN CHANGE ONLY THOSE FIELDS THAT ARE REQUIRED BY THE NEW SUBMISSION.
LESLYE, SHIPMENT PLANS DO CHANGE. UNDER WHAT CIRCUMSTANCES WOULD I HAVE TO DO A PRIOR NOTICE AGAIN IF I HAVE A CHANGE IN PLANS?
FRASER: IT DEPENDS ON THE NATURE OF THE INFORMATION THAT IS CHANGING. IN THE INTERIM FINAL RULE, WE ALLOW SUBMITTERS TO TELL US WHAT IS THE ESTIMATED QUANTITY OF WHAT THEY'RE BRINGING IN. SO IF THAT INFORMATION CHANGES, THEY SEND MORE THAN THEY TOLD US OR LESS THAN THEY TOLD US, OR THEY DON'T SEND THE PRODUCT AT ALL, THEN NO ACTION IS REQUIRED. SAME THING WITH ANTICIPATED ARRIVAL INFORMATION. WE ONLY ASK FOR THEM TO LET US KNOW WHERE THE FOOD WILL BE ENTERING THE COUNTRY AND IF THERE'S MORE THAN ONE BRIDGE CROSSING TO LET US KNOW THAT, THE DATE AND TIME OF ARRIVAL. AND IF THAT INFORMATION CHANGES AS WELL, THEN WE ALSO DON'T REQUIRE THEM TO SEND US ANY OTHER INFORMATION. THEY ALSO CAN CHANGE THE PLANNED SHIPMENT INFORMATION SUCH AS (*See errata) THE CARRIER. (*See errata) IT ENDS UP ON A DIFFERENT PLANE THAN THE ONE THEY ORIGINALLY TOLD US OR A DIFFERENT VESSEL. OR THEY CAN CHANGE THE ESTIMATED DATE OF MAILING IF THEY'RE SENDING IT INTERNATIONAL MAIL. NONE OF THOSE CHANGES REQUIRE ANY ACTION ON THEIR PART. HOWEVER, IF ANY OF THE OTHER INFORMATION CHANGES, THEN THEY DO NEED TO SEND A NEW PRIOR NOTICE. AND WE ASK THAT THEY CANCEL THE FORMER PRIOR NOTICE, SO THAT WE DON'T HAVE EXCESSIVE CLUTTER IN OUR SYSTEM. AND IF THEY ALSO DECIDE NOT TO SEND THE PRODUCT AT ALL, WE ALSO ASK THAT THEY CANCEL THE PRIOR NOTICE THEY HAVE ORIGINALLY SENT.
LET ME GIVE YOU ANOTHER KIND OF EXAMPLE THAT GOES BEYOND THE THINGS THAT YOU MENTIONED. SUPPOSE THAT I'M GETTING A SHIPMENT OF MIXED SEAFOOD, AND AT THE LAST MINUTE THE SUPPLIER DECIDES TO ADD LOBSTER AND I DIDN'T HAVE THAT ON THERE ORIGINALLY. WHAT ABOUT THAT?
FRASER: IF YOU DIDN'T HAVE THAT ON THERE ORIGINALLY, AND THAT'S A PRACTICE THAT OFTEN IS CALLED "TOPPING OFF THE CONTAINER." YOU CAN NOT DO THAT WITHOUT PROVIDING US ADEQUATE PRIOR NOTICE. SO DEPENDING ON HOW THE LOBSTER IS COMING IN, WE WOULD NEED TO HAVE THE PRIOR NOTICE SUBMITTED IN THE TIME FRAME THAT IS TIED TO THAT MODE OF TRANSPORTATION.
SO IN THIS CASE I COULDN'T SEND YOU AN AMENDMENT, LET'S SAY, TO TALK ABOUT THE LOBSTER?
FRASER: NO, AND EVEN UNDER THE PROPOSED RULE, YOU COULDN'T ADD A NEW ITEM UNDER AN AMENDMENT. BUT WE DON'T HAVE ANY AMENDMENTS OR UPDATES IN THE INTERIM FINAL RULE, BECAUSE THE TIME FRAMES ARE SO SHORT.
DEBBIE, LET'S TALK ABOUT CONSEQUENCES. WHAT HAPPENS IF PRIOR NOTICE ISN'T ADEQUATE OR IT WASN'T SUBMITTED AT ALL.
RALSTON: WELL, IF PRIOR NOTICE SUBMISSION DOESN'T COME IN, IT'S MISSING OR IT IS INADEQUATE, THE FOOD IS SUBJECT TO REFUSAL OF ADMISSION TO THE UNITED STATES UNDER THE PRIOR NOTICE REGULATIONS. ANY INADEQUATE PRIOR NOTICE SUBMISSION, AS GEORGE INDICATED EARLIER, WON'T RECEIVE AN ELECTRONIC CONFIRMATION, AND THE FOOD WILL BE CONSIDERED TO BE REFUSED UNTIL SUCH TIME AS A PROPER PRIOR NOTICE HAS BEEN SUBMITTED.
SO WHAT HAPPENS TO IT?
RALSTON: WELL, IT'S HELD AT THE PORT OF STORAGE^-- HELD AT THE PORT OF ENTRY, OR (*See errata) CUSTOMS OR FDA CAN DIRECT IT TO SECURED STORAGE UNTIL SUCH TIME AS THE^-- (*See errata)
SO LET'S SAY IT'S BEING HELD. DO I STILL HAVE THE OPPORTUNITY THEN TO SUBMIT MY PRIOR NOTICE WHILE IT'S BEING HELD?
TALK A LITTLE BIT ABOUT THE LEGAL (*See errata) CONSEQUENCES OF FAILING TO COMPLY WITH PRIOR NOTICE.
RALSTON: THE INTERIM FINAL RULE PROVIDES THAT IF A PERSON FAILS TO SUBMIT A PRIOR NOTICE, THAT INDIVIDUAL IS POTENTIALLY SUBJECT TO THE CIVIL OR CRIMINAL ACTIONS THAT FDA COULD BRING. IN ADDITION, THE AGENCY CAN SEEK DEBARMENT OF THAT INDIVIDUAL IF THAT PERSON HAS BEEN CONVICTED OF A FELONY INVOLVING THE IMPORTATION OF A FOOD PRODUCT INTO THE UNITED STATES.
LET ME ASK YOU THE SAME QUESTION I ASKED LANA DURING THE FIRST PANEL. AND THAT IS, DOES THE FDA INTEND TO START ENFORCING IN THAT WAY ON DECEMBER THE 13th, A DAY AFTER THIS THING GOES INTO EFFECT?
RALSTON: NO, AS DR.^McCLELLAN SUGGESTED IN HIS OPENING REMARKS FOR THIS BROADCAST, THE AGENCY INTENDS TO EXERCISE DISCRETION IN ITS ENFORCEMENT OF THE PRIOR NOTICE REGULATION WHILE AT THE SAME TIME TRYING TO ENSURE THE SAFETY OF THE PUBLIC. THIS WILL OCCUR DURING THE IMPLEMENTATION PERIOD SHORTLY AFTER DECEMBER^12th, AND IN PART, FOR AN EXTENDED PERIOD THEREAFTER. THE AGENCY RECOGNIZES THAT THERE ARE PERSONS OUT THERE WHO HAVEN'T REALLY HAD A CHANCE TO LEARN THE ENTIRE CONTENT OF THE REGULATION OR UNDERSTAND HOW THEY MUST COMPLY. AND TO THAT END, WE'RE LOOKING TO ASSIST THEM BY CONTINUING OUR OUTREACH AND OUR EDUCATION EFFORTS. WITHIN THE NEXT COUPLE WEEKS, WE EXPECT TO PUBLISH A COMPLIANCE POLICY GUIDE WHICH WILL PROVIDE A GENERAL AND BROAD OVERVIEW OF HOW WE'RE GOING TO BE EXERCISING OUR ENFORCEMENT DISCRETION.
NOW, YOU TALK ABOUT EDUCATION AND OUTREACH AND SO ON FOR THE INITIAL PERIOD. BUT WHAT IF A SITUATION OCCURS THAT POSES A GENUINE PUBLIC HEALTH THREAT. I MEAN, WHAT HAPPENS THEN?
RALSTON: WELL, THERE'S NO QUESTION THAT WHILE WE WOULD LIKE TO EXERCISE THE ENFORCEMENT DISCRETION I JUST DESCRIBED, OUR PRIMARY MISSION IS PROTECTING THE PUBLIC HEALTH. AND THAT IS WHY THE BIOTERRORISM ACT WAS ENACTED. WE INTEND TO TAKE WHATEVER ACTION WE NEED TO TAKE IN ORDER TO ASSURE THAT THE PUBLIC'S HEALTH IS PROTECTED. IT MAY INVOLVE INSPECTION OF PRODUCTS AT THE PORT OF ENTRY, WE MAY BE COLLECTING SAMPLES FOR FOOD SAFETY AND SECURITY REASONS. A NUMBER OF DIFFERENT THINGS CAN HAPPEN THAT WILL HELP US ENSURE THE PUBLIC HEALTH. IN ADDITION, CUSTOMS AND BORDER PROTECTION IS NOT PRECLUDED FROM TAKING INDEPENDENT ACTIONS. THEY HAVE THE ABILITY TO ASSESS PENALTIES, AS WELL AS A NUMBER OF OTHER SANCTIONS AGAINST PRODUCT THAT IS CONSIDERED SUSPECT OR POTENTIALLY HARMFUL.
CATHY, WHAT EFFECT WILL PRIOR NOTICE HAVE ON CUSTOMS CLEARANCE?
SAUCEDA: PRIOR NOTICE UNDER THE BIOTERRORISM ACT WILL HAVE A PRETTY MAJOR IMPACT ON THE FOOD ARTICLES THAT ARE COVERED BY THE ACT. EVEN OUR MOST COMMON ENTRY TYPES OF CONSUMPTION ENTRY LET'S SAY AND WAREHOUSE ENTRY, PRIOR NOTICE IS GOING TO HAVE TO BE SATISFIED BEFORE IT LEAVES CUSTOMS' CUSTODY. IN FACT, IF PRIOR NOTICE ISN'T MET, THE THINGS THAT DEBBIE JUST TALKED ABOUT, HOLDING IT AT THE PORT OR SENDING IT TO SECURE FACILITIES, THAT'S WHAT'S GOING TO GO INTO PLAY. SO EVEN FOR 80% OF OUR TRADE, THERE WILL BE A HUGE IMPACT.
AND THAT INCLUDES IN-BOND ENTRIES, INFORMAL ENTRIES? (*See errata)
SAUCEDA: IN-BOND ENTRIES, INFORMAL ENTRIES, FOREIGN TRADE ZONE ENTRIES, CARNETS^-- ALMOST EVERY SINGLE TYPE OF CUSTOMS ENTRY IS GOING TO BE IMPACTED BY THE ACT.
WHAT IF I HAVE A SHIPMENT THAT'S OF VERY LITTLE MONETARY VALUE? IS THAT GOING TO BE AFFECTED AS WELL?
SAUCEDA: IF IT'S A COMMERCIAL SHIPMENT OF LITTLE MONETARY VALUE, THERE'S NO DE^MINIMUS IN THE ACT. AND AS DEBBIE AND CATHY BOTH TALKED ABOUT, TRADE SAMPLES, COMMERCIAL MERCHANDISE COMING IN A CAR OR SOMETHING, ALL HAS TO SATISFY THE REQUIREMENT TO PRIOR NOTICE.
LESLYE, THE COMMISSIONER TALKED ABOUT THE FACT THAT THIS IS AN INTERIM FINAL RULE. EXPLAIN ONCE AGAIN WHAT THAT MEANS.
FRASER: AT INTERIM FINAL RULE IS A FINAL RULE THAT DOES IMPOSE BINDING REQUIREMENTS ON THE PARTIES THAT ARE SUBJECT TO THE RULE. SO AS OF DECEMBER 12th, BOTH REGISTRATION AND PRIOR NOTICE DO GO INTO EFFECT. AND EVEN THOUGH THE AGENCY MAY BE EXERCISING ENFORCEMENT DISCRETION, THAT TALKS ABOUT HOW WE WILL RESPOND TO VIOLATIONS OF THE ACT. IT DOES NOT SAY THAT THE OBLIGATIONS AND THE REGULATIONS DO NOT TAKE EFFECT. WHAT AN INTERIM FINAL RULE DOES, THOUGH, IS ALLOW AFFECTED PARTIES TO PROVIDE^-- OR ANYONE FOR THAT MATTER, STAKEHOLDERS, TO PROVIDE COMMENTS TO THE AGENCY WHILE "IN THE INTERIM," THE REGULATION IS IN EFFECT. I WANT TO NOTE THAT THOSE COMMENTS ARE ON THOSE AREAS THAT WE HAVE SPECIFIED IN EACH RULE, SO WE'RE NOT ASKING FOR COMMENTS ACROSS THE BOARD. BUT THERE ARE CERTAIN AREAS THAT WE HAVE DESIGNATED THAT WE ARE INTERESTED IN RECEIVING ADDITIONAL COMMENT, AND THEN WE WILL TAKE COMMENTS FOR 75^DAYS OR THROUGH DECEMBER^24th OF THIS YEAR. AND THEN IN ABOUT MARCH, OUR TWO AGENCIES ARE WORKING TOGETHER TO DEVELOP A PLAN IN WHICH WE LOOK FURTHER AT HOW WE CAN BETTER COORDINATE THE REQUIREMENTS WE HAVE UNDER THIS PRIOR NOTICE REGULATION AS WELL AS THE REQUIREMENTS THAT CUSTOMS AND BORDER PROTECTION WILL HAVE UNDER THEIR PRIOR NOTICE ADVANCE MANIFEST INFORMATION. AND WHEN WE PUBLISH THAT PLAN, WE WILL OPEN, OR REOPEN, THE COMMENT PERIOD FOR A PERIOD OF TIME TO TAKE ADDITIONAL COMMENT.
NOW, YOU DO HAVE A WAY THAT PEOPLE CAN GET UPDATED ON INFORMATION ON PRIOR NOTICE ON ALMOST A CONTINUING BASIS. AM I RIGHT?
FRASER: ABSOLUTELY. AND IT GENERALLY APPLIES TO BEING ABLE TO GET INFORMATION ON OUR PROGRESS UNDER THE BIOTERRORISM ACT GENERALLY. SO FOR REGISTRATION, PRIOR NOTICE, AS WELL AS THE OTHER REGULATIONS THAT WE ARE DEVELOPING. AND THAT AGAIN IS AT WWW.FDA.GOV. AND WHEN YOU GET THERE, YOU CAN CLICK ON "BIOTERRORISM." THERE ALSO IS, IF YOU DO NOT HAVE INTERNET ACCESS, YOU ALSO CAN WRITE TO THE FOOD & DRUG ADMINISTRATION AT THE DOCKETS MANAGEMENT BRANCH, AT 5630 FISHERS LANE, ROOM 1061, ROCKVILLE, MARYLAND, USA, 20852. SOME OF THE THINGS I'D LIKE TO POINT OUT THAT YOU CAN FIND ON THAT SITE. YOU CAN FIND FACT SHEETS ABOUT EACH OF THE REGULATIONS THAT SUMMARIZE THE REQUIREMENTS. YOU CAN FIND POWERPOINT PRESENTATIONS IF YOU WANT TO USE TO SHOW TO SOMEONE ELSE. WE ALSO WILL BE POSTING SOME OF OUR INFORMATION IN EIGHT DIFFERENT LANGUAGES FOR PRIOR NOTICE AND REGISTRATION INCLUDING ARABIC, CHINESE, JAPANESE, SPANISH, FRENCH, PORTUGUESE, MALAY, AND HINDI. WE WILL BE REBROADCASTING THIS SATELLITE DOWNLINK ON THURSDAY AND FRIDAY OF THIS WEEK, THE 30th AND 31st, TO OTHER PARTS OF THE WORLD AT THEIR LOCAL TIME. AND INFORMATION ON THAT REBROADCAST CAN BE FOUND AT THAT SAME WEBSITE. WE ALSO WILL BE POSTING A VIDEO STREAM OF THIS SATELLITE BROADCAST THAT PEOPLE CAN GO AND VIEW LIVE FROM THEIR OWN^-- LIVE IN THE SENSE FROM THEIR OWN DESKTOP. AND THAT WILL BE POSTED ON THE WEBSITE IN ABOUT TWO WEEKS. AND LASTLY, WE WILL BE MAKING COPIES OF THIS BROADCAST AND POSTING THEM ON CD-ROM. AND IF PEOPLE WOULD LIKE TO OBTAIN A COPY ON A CD, THEY CAN FIND OUT HOW ON OUR WEBSITE. SO WE DO ENCOURAGE PEOPLE TO LOG IN THERE.
OKAY, NOW, WE HAVE ONLY ABOUT TEN MINUTES LEFT. I HAVE A PILE OF QUESTIONS THAT HAVE COME IN BEFORE THE BROADCAST, ANOTHER PILE THAT CAME IN DURING, WE'LL COVER AS MANY OF THESE AS WE CAN. PLEASE KEEP THEM SHORT, OKAY? OKAY, DEBBIE, WHEN IS FDA SCHEDULED TO ISSUE ITS COMPLIANCE POLICY GUIDE ON PRIOR NOTICE, INCLUDING HOW IT PLANS TO EXERCISE ITS ENFORCEMENT DISCRETION? WILL THESE GUIDES BY OPEN FOR PUBLIC COMMENT?
RALSTON: WELL, THE ANSWER IS WITHIN THE NEXT TWO WEEKS WE INTEND TO PUBLISH. AND YES, IT WILL BE OPEN FOR PUBLIC COMMENT.
LESLYE AND CATHY, COULD FDA GIVE MORE INFORMATION ON PLANNED OUTREACH ACTIVITIES? WILL CUSTOMS BE DOING ACTIVITIES SPECIFICALLY TARGETED TO BROKERS AND IMPORTERS?
SAUCEDA: YOU WANT TO GO FIRST? I'LL GO FIRST?
FRASER: YOU GO AHEAD.
SAUCEDA: OKAY. WE HAVE A VERY FULL SCHEDULE OF OUTREACH ACTIVITIES FOR ALL TYPES OF TRADERS, INCLUDING BROKERS, CARRIERS, EXPORTERS AND MANUFACTURERS. WE HAVE NOT DECLINED AN INVITATION YET TO SPEAK AT VARIOUS FUNCTIONS, SO WE INTEND TO CONDUCT OUTREACH, I WOULD ASSUME, FOR AT LEAST PROBABLY THE NEXT YEAR I THINK THERE WILL STILL BE AN INTEREST.
OKAY.
FRASER: FDA ALSO HAS ACCEPTED A NUMBER OF INVITATIONS TO SPEAK AT VARIOUS MEETINGS. WE WILL BE HAVING OUR OWN MEETINGS ACROSS THE COUNTRY IN VARIOUS CITIES OVER THE NEXT SEVERAL WEEKS. AND AGAIN I ENCOURAGE PEOPLE TO GO TO WWW.FDA.GOV TO FIND OUT HOW TO SIGN UP FOR THOSE MEETINGS. THEY WILL BE FREE. WE BASICALLY WILL BE PRESENTING THE INFORMATION YOU SAW TODAY, SO PLEASE NOTIFY YOUR COLLEAGUES AND THE REST OF OUR OUTREACH ACTIVITIES AND SCHEDULE WILL BE POSTED THERE AS WELL.
OKAY, HOW ARE IN-TRANSIT ENTRIES HANDLED? AGAIN, SLOWLY, BUT BRIEFLY.
FRASER: THEY ARE SUBJECT TO PRIOR NOTICE BECAUSE THE FOOD IS COMING ACROSS OUR BORDER.
OKAY, GEORGE, AS THE CARRIER IS EXTREMELY UNLIKELY TO BE THE PARTY FILING THE PRIOR NOTICE INFORMATION, HOW WOULD IT KNOW IF THE FILER HAS USED THE ABI OR THE PRIOR NOTICE SYSTEM?
BRUSH: WELL, IT'S NOT REALLY THAT IMPORTANT THAT THE CARRIER KNOW HOW THE INFORMATION WAS SUPPLIED, WHETHER IT CAME THROUGH THE PRIOR NOTICE SYSTEM INTERFACE OR WHETHER IT CAME THROUGH CBP'S ACS, THE INFORMATION WILL BE AVAILABLE AT THE BORDER. SO IT'S NOT REALLY IMPORTANT THAT THEY KNOW THAT.
FRASER: WELL, IF I COULD ADD TO THAT, I THINK PERHAPS ONE PART OF THAT IS IF IT'S FILED THROUGH OUR SYSTEM, THEY NEED A COPY OF THE CONFIRMATION, SO THAT IS SOMETHING THAT THE CARRIER NEEDS TO CHECK WITH WHOMEVER THEY'RE PICKING THE FOOD UP FROM, SO THAT THEY CAN MAKE SURE THEY HAVE A COPY OF THE CONFIRMATION IF THAT'S REQUIRED.
BRUSH: THAT'S RIGHT. WE'RE ABSOLUTELY RECOMMENDING THE CARRIER HAVE THE CONFIRMATION NUMBER WITH HIM WHEN HE CROSSES THE BORDER.
OKAY, LESLYE, IF A PRODUCT FROM THE KNOWN GROWER IS COMMINGLED WITH PRODUCT FROM UNKNOWN GROWERS, MAY THE SUBMITTER STILL IDENTIFY THE CONSOLIDATOR INSTEAD OF THE GROWER?
FRASER: THAT'S A VERY COMPLICATED QUESTION AND IT'S ANSWERED IN PRETTY GOOD DETAIL IN THE PREAMBLE TO THE RULE. SO WE DO ENCOURAGE PEOPLE TO READ THE RULE. BUT, BASICALLY, IT DEPENDS ON WHEN THE CONSOLIDATION OCCURS. IF YOU KNOW THE GROWER, THEN THE BIOTERRORISM ACT REQUIRES YOU TO TELL US WHO IS THE GROWER AS PART OF THE INFORMATION. IF YOU TAKE TOMATOES, FOR EXAMPLE, IF THEY'RE COMMINGLED IN ONE BIG CRATE, THEN THEY CAN GIVE US THE CONSOLIDATOR, BUT IF BASICALLY WHAT THEY'RE DOING IS CONSOLIDATING CRATES OF TOMATOES THEY GOT FROM GROWER "A" WITH CRATES OF TOMATOES THEY HAVE FROM FIVE OTHER GROWERS, THEN THEY SHOULD FILE A SEPARATE PRIOR NOTICE FOR THE GROWER "A" TOMATOES, AND THEN THE CONSOLIDATED CAN BE USED FOR THE REST.
LESLYE, IF A FRIEND IN GERMANY WANTS TO MAIL ME CHRISTMAS CAKES HE PURCHASED, DOES HE HAVE TO REGISTER AND SUBMIT PRIOR NOTICE? I AM AN INDIVIDUAL AND SO IS MY FRIEND. HE DOES NOT MANUFACTURE AND I DO NOT RESELL.
FRASER: IF YOUR FRIEND SENDS YOU CHRISTMAS CAKES THAT HE PURCHASED, YES, HE HAS TO FILE PRIOR NOTICE. AND IT'S ALONG^-- CONSISTENT WITH THE REQUIREMENTS FOR INTERNATIONAL MAIL. YOUR FRIEND WOULD NOT HAVE TO REGISTER, HOWEVER, BECAUSE HE IS NEITHER A MANUFACTURER, PROCESSOR, PACKER OR HOLDER OF FOOD OUTSIDE OF HIS HOME.
CATHY, HOW DOES SUBMISSION OF PRIOR NOTICE AFFECT THE TIMING OF EXISTING CUSTOMS ENTRY PROCEDURES FOR THE SAME ARTICLE? FOR INSTANCE, CUSTOMS REGULATIONS MAY NOT PERMIT SUBMISSION OF ENTRY INFORMATION UNTIL WHEELS UP FOR PRODUCT ARRIVING BY AIR. BUT FDA REQUIRES PRIOR NOTICE FOR AIR CARGO FOUR HOURS PRIOR TO ARRIVAL. DOES THE SUBMITTER HAVE TO MAKE TWO SUBMISSIONS, ONE TO CUSTOMS OR ENTRY, AND ONE TO FDA FOR PRIOR NOTICE?
SAUCEDA: WELL, THE WAY THE QUESTION IS PHRASED, IT KIND OF COMBINES ABOUT THREE DIFFERENT THINGS, ENTRY, PRIOR NOTICE, AND THE TRADE ACT. BUT LET ME ANSWER THE SIMPLEST ONE HERE. THE ENTRY INFORMATION THAT IS PRESENTED TO CUSTOMS CAN BE FILED MANY DAYS, AND IN FACT, SEVERAL MONTHS OUT. SO REALLY THE ONLY LIMITATION THAT SOMEONE HAS IS THE FIVE-DAY MAXIMUM THAT FDA HAS ON THE SUBMISSION OF PRIOR NOTICE. BUT IF INDEED SOMEONE FILES ENTRY INFORMATION TWO WEEKS OUT, THEN THEY WOULD HAVE TO FOLLOW UP NO MORE THAN FOUR DAYS OUT WITH A PRIOR NOTICE INFORMATION. BUT GENERALLY SPEAKING, IT SHOULD ALL BE EASY TO SUBMIT AT ONE TIME.
OKAY. I'M GOING TO GO ON TO ANOTHER QUESTION^-- THAT'S A GOOD ANSWER AND A GOOD QUICK ANSWER. LET ME GO ON TO ANOTHER QUESTION. IF A FEED COMPANY IN THE U.S.^WANTED A COMPANY IN CANADA TO MAIL A ONE-POUND SAMPLE OF MULCH SPROUTS FOR EXAMINATION PRIOR TO PURCHASING LARGE AMOUNTS, WOULD PRIOR NOTICE BE REQUIRED FOR THAT SAMPLE?
FRASER: YES. PRIOR NOTICE IS REQUIRED FOR SAMPLES.
OKAY. GEORGE, WILL AN ELECTRONIC-ONLY INTERFACE BE MADE AVAILABLE FOR SOFTWARE VENDORS TO AUTOMATE THE PRIOR NOTICE?
BRUSH: WELL, THE INTERFACE CATHY SPOKE OF EARLIER, UNLESS THEY'RE TALKING ABOUT A DIRECT TO FDA INTERFACE, WE HAVE NO PLANS FOR THAT. BUT IF THEY'RE TALKING ABOUT THE INTERFACE BETWEEN ABI AND ACS, THEN THOSE ARE THE SPECIFICATIONS THAT CATHY REFERENCED AND THEY WILL BE MADE AVAILABLE.
FRASER: AND NO INTERFACE IS NEEDED TO ACCESS THE FDA SYSTEM ONCE YOU HAVE A COMPUTER AND HAVE INTERNET ACCESS.
DEBBIE, WILL THE FDA HAVE RESOURCES AVAILABLE 24/7^AT ALL PORTS OF ARRIVAL? IF NOT, HOW WILL SHIPMENTS IN QUESTION BE PROCESSED AND BY WHOM?
RALSTON: WELL, I THINK THERE'S A BIT OF CONFUSION ON THE PART OF THAT QUESTION. PRIOR NOTICE WILL BE PROCESSED AT A CENTRALIZED LOCATION FOR ALL PORTS OF ENTRY. AND THAT WILL OCCUR 24^HOURS A DAY, 7 DAYS A WEEK.
OKAY, I'M GOING TO DO ONE MORE, BECAUSE I THINK WE'RE RUNNING VERY CLOSE TO TIME HERE. GEORGE, IF A CONTAINER ENTERS THE U.S.^AND PRIOR NOTICE IS GIVEN, BUT THE GOODS GO DIRECTLY TO AN FTZ, THEN^-- I'M TRYING TO READ THIS^-- AND THEN PIECEMEALED OUT WITH SEVERAL CONSUMPTION ENTRIES, WILL YOU USE THE ORIGINAL PRIOR NOTICE WITH EACH CONSUMPTION ENTRY?
SAUCEDA: I SHOULD PROBABLY ANSWER THAT.
BRUSH: SOMEBODY OTHER THAN ME.
WE HAD A FIGHT ON THE LAST ONE. OKAY, GO AHEAD.
SAUCEDA: FOR GOODS BEING ADMITTED INTO A FOREIGN TRADE ZONE, IT IS THE ADMISSION INTO THE FOREIGN TRADE ZONE THAT REQUIRES THE PRIOR NOTICE. IT'S NOT THE WITHDRAWALS FROM THE FOREIGN TRADE ZONES. SO IT WOULD BE PRIOR NOTICE FILED AT THE TIME OF ADMISSION TO THE ZONE.
OKAY. LET'S PLAY IT DANGEROUS AND WE'LL TRY ANOTHER ONE. ARE DUTY-FREE STORES EXEMPT FROM NOTIFICATION?
FRASER: IT DEPENDS ON WHERE THE DUTY-FREE STORE IS LOCATED AND WHETHER IT'S COUNTED AS IMPORTED INTO THE UNITED STATES, AND SO THAT DEPENDS ON THE CUSTOMS.
SAUCEDA: CURRENTLY, WE'RE TAKING THE POSITION THAT DUTY-FREE STORES REQUIRE^-- THOSE FOOD ITEMS REQUIRE PRIOR NOTICE.
LAST ONE, FOR SURE. GEORGE, THIS ONE IS FOR YOU. WILL FIRMS IMPORTING BE ABLE TO TEST THE SYSTEM PRIOR TO DECEMBER THE 12th? SEE IF THEY LIKE IT?
BRUSH: WELL, UNFORTUNATELY NOT. THE SYSTEM WON'T BE AVAILABLE UNDER DECEMBER^12th.
OKAY. AND THAT WAS THE LAST WORD. THANK YOU ALL FOR A VERY GOOD DISCUSSION. THANK YOU FOR WATCHING. WE HOPE YOU FOUND THIS BROADCAST INTERESTING AND THE INFORMATION IN IT USEFUL TO YOU. CAN WE GET OUR PROMPTER MOVING HERE? GOOD. OKAY, AND I WANT TO CLOSE WITH AN IMPORTANT REMINDER. ALTHOUGH THESE ARE INTERIM FINAL RULES, THEY WILL HAVE THE FULL EFFECT OF LAW WHEN THEY GO INTO EFFECT ON DECEMBER^12th. AGAIN, WE REALLY WANT YOUR COMMENTS ON THOSE SPECIFIC AREAS IN THE INTERIM FINAL RULES WHERE WE'RE ASKING FOR COMMENT. SO PLEASE SEND THEM TO OUR DOCKETS MANAGEMENT BRANCH. IN JUST A MOMENT, WE'LL SHOW THAT ADDRESS ON THE SCREEN, AND WE'LL ALSO SHOW THE FDA BIOTERRORISM WEBSITE ADDRESS WHERE YOU CAN GET INFORMATION ON FUTURE BROADCASTS. UNTIL THEN, THIS IS MARK^BARNETT.
(See Errata Sheet)
