Kam Quarles provided this summary of the Tester amendment today. The food safety debate is ongoing today and below this summary of the Tester amendment is a transcript of Tester remarks to Congress about his amendment.


Summary of Tester Amendment

Senator Jon Tester (D-MT) has sponsored an amendment to the food safety bill (S. 510) to further protect small, local food processors and producers.

Retail Food Establishments:

In the 2002 Bioterrorism Act, Congress required that all facilities that manufacture, process, pack, or hold food must register with FDA, but it  exempted from that requirement “retail food establishments.” FDA defined the term at 21 CFR
1.227(b)(11). For purposes of the definition, the Tester amendment would require FDA to clarify that “direct sales” of food to consumers includes sales that occur other than where the food was manufactured, such as at a roadside stand or farmers’ market.

Qualified Exemptions:

-Facilities:
• Food facilities would qualify for an exemption from the preventive control/HACCP provisions in section 103 of S. 510 under certain conditions:
(1) they are either a “very small business” as defined by FDA in rulemaking; or (2) the average annual monetary value of all food sold by the facility during the previous 3 year period was less than $500,000, but only so long as the majority of the food sold by that facility was sold directly to consumers, restaurants, or grocery stores (as opposed to 3rd party food brokers) and were in the same state where the facility sold the food or within 275 miles of the facility.

• Facilities that qualify would be exempt from the preventive control/HACCP provisions in S. 510, but would still have to comply with one of the following:
(1) They would have to demonstrate that they have identified potential hazards and are implementing preventive controls to address the hazards,
or (2) they would have to demonstrate to FDA that they are in compliance with state or local food safety
laws.
• Disclosure: Any food sold by a facility that opts for compliance option
(2), above, would have to prominently and conspicuously provide the name and address of the facility that produced it on a food packaging label, or at the point of purchase, as appropriate.
• Study: FDA would have to conduct a study of the food processing sector to help inform the definition of what it means to be a “very small” facility for purposes of the exemption above.

-Farms:

• Farms would qualify for an exemption from the produce safety standards in section 105 of S. 510 if, during the previous 3 year period, the average monetary value of the food they sold was less than $500,000, but only so long as the majority of sales were to consumers, restaurants, or grocery stores (as opposed to 3rd party food brokers) and were in the same state where the farm  harvested or produced the food or within 275 miles of the farm.

• Any food sold under the exemption would have to have the same disclosure set forth above.

-Limitation:

• In the event of an active investigation of a foodborne illness outbreak that is directly linked to a facility or farm exempted under this section, or if the Secretary determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a facility or
farm that are material to the safety of food, the Secretary may withdraw the exemption provided to such facility under this section. No activities under this limitation expand existing FDA authorities to inspect farms.

PROGRAM SEGMENT
Senate Session, Part 1
Nov 18, 2010

MR. TESTER

Length: 6 minutes, 21 seconds

TK: Here is transcript from Congress today, taken from the C-Span closed caption. You probably will not like all of what he says.


01:34:11 I WOULD LIKE TO MAKE A BRIEF STATEMENT ABOUT THE FOOD SAFETY BILL.
01:34:15 I VERY MUCH APPRECIATE THE OPPORTUNITY NOW THAT THIS IMPORTANT LEGISLATION IS SHAPING UP TO BE A MUCH BETTER BILL WITH THE INCLUSION OF MY AMENDMENT FOR FAMILY PRODUCERS AND IT PROTECTS THE JOBS OF FAMILY FARMERS, RANCHERS AND PROCESSORS.
01:34:29 THIS IS REALLY TIME TO GET THE BILL PASSED AND STRENGTHEN FOOD SAFETY FOR ALL AMERICANS.
01:34:35 I THINK THERE'S LITTLE AGREEMENT THAT THE NECESSITY OF THIS BILL IS REAL.
01:34:39 I THINK IF YOU TAKE A LOOK AT THE IMPACTS OF -- OF RECENT E.
01:34:45 COLI OUTBREAKS OF SALMONELLA AND THOSE KIND OF FOOD-BORNE DISEASES OUT THERE, IT IS -- IT IS ABSOLUTELY CRITICAL WE GET THIS BILL PASSED.
01:34:53 I HAD HAD SOME CONCERNS WITH INTRODUCED.
01:34:56 THIS BILL AS IT WAS ORIGINALLY ON ITS IMPACTS TO FAMILY-SIZED GROWERS AN PROCESSORS -- AND PROCESSORS.
01:35:07 THE FACT OF THE MATTER IS THESE FOLKS ARE FOLKS THAT REALLY HELP BUILD THIS COUNTRY AND -- AND UNDUE REGULATION ON THEM, AND I DO THINK IT WOULD BE UNDUE REGULATION WOULD SIMPLY STOP A MOVEMENT IN THIS COUNTRY THAT HAS GONE ON SINCE THIS COUNTRY'S INCEPTION, BUT MORE RECENTLY WE'VE KIND OF GONE BACK TO IT WITH LOCALLY PRODUCED FOODS.
01:35:28 SO I THINK IT'S CRITICALLY IMPORTANT THAT THE -- THAT MY AMENDMENT BE A PART OF THIS BILL AND I APPRECIATE EVERYBODY WHO -- WHO WORKED TO MAKE THAT HAPPEN.
01:35:39 AND HERE'S WHY, WE DEAL WITH CONSOLIDATION IN OUR ENERGY SECTOR.
01:35:42 WE DEAL WITH CONSOLIDATION IN OUR BANKING SECTOR.
01:35:44 WE'VE DONE IT SINCE I'VE GOTTEN HERE AND BEFORE.
01:35:48 FOOD INDUSTRY TOO.
01:35:48 WE HAVE CONSOLIDATION IN OUR THE FACT IS IT -- IS THAT WE CONSOLIDATION.
01:35:54 NEED TO NOT ENCOURAGE THAT I THINK IF WE CAN GET MORE LOCALLY GROWN FOOD, IF WE CAN GET PRODUCERS TO CONNECT UP WITH CONSUMERS EYEBALL TO EYEBALL, THAT'S A POSITIVE THING.
01:36:07 ABILITY.
01:36:07 I DON'T WANT TO DIMINISH THIS MY WILL PROTECTS THE FARMER MARKETS TO FLOURISH AND -- AND PROVIDE FOOD FOR PEOPLE LOCALLY.
01:36:16 WITHOUT SHIPPING IT HALFWAY AROUND THE WORLD AND BACK AGAIN.
01:36:22 AND, YET, THIS BILL ALSO PUTS REGULATION ON THE INDUSTRIALIZED FOLKS THAT THE -- THAT, QUITE FRANKLY, BECAUSE OF THE SIZE OF THEIR OPERATION, BECAUSE OF THEM BEING HIGHLY -- WHEN A MISTAKE IS MADE, IT CAN AFFECT HUNDREDS OF THOUSANDS OF PEOPLE IN 10, 20, 30 STATES.
01:36:43 IN THIS BILL REALLY IS WANE-WIN FOR CONSUME -- A WIN-WIN FOR CONSUMERS BOTH LOCALLY AND THE CONSUMERS THAT DEAL WITH THE -- THE MORE HIGHLY INDUSTRIALIZED FOOD SUPPLIERS.
01:36:56 NOW, PEOPLE HAVE ASKED ME, YOU KNOW, WHY DO YOU THINK -- WHY DO YOU THINK THE SMALL GUYS CAN EVEN BE REGULATED BY THE LOCAL AND STATE REGULATORS IN THIS COUNTRY?
01:37:08 FIRST OF ALL, THEY'RE SMALL, THERE IS A PRIDE OF OWNERSHIP THERE THAT IS REAL.
01:37:14 THEY RAISE FOOD.
01:37:16 THEY DON'T RAISE A COMMODITY AS -- AS HAPPENS WHEN -- WHEN THE OPERATIONS GET BIGGER AND BIGGER, AND THERE IS A DIRECT CUSTOMER RELATIONSHIP WITH THAT PROCESSOR OR THAT FARMER THAT MEANS A LOT.
01:37:30 AND IF A MISTAKE IS MADE, WHICH RARELY HAPPENS, IT DOESN'T IMPACT HUNDREDS OF THOUSANDS OF PEOPLE.
01:37:37 WE KNOW EXACTLY WHERE THE PROBLEM WAS AND WE KNOW EXACTLY HOW TO FIX IT.
01:37:44 AND, SO, THE TRACEABILITY OF THE OUTBREAKS IS IMMEDIATE AND IS TAKEN CARE OF WITHOUT IMPACTING 20, 30 STATES AND HUNDREDS OF THOUSANDS OF PEOPLE.
01:37:54 SO AS WE MOVE FORWARD WITH THIS BILL, I THINK IT'S -- IT'S INCREDIBLY IMPORTANT THAT WE DO THINGS LIKE WE DID IN THE LAST FARM BILL.
01:38:04 MOVE FORWARD WITH LOCALLY GROWN FOOD, MOVE FORWARD WITH THE FARMERS MARKET KIND OF MODEL THAT HELPS PEOPLE GET TO KNOW THE PEOPLE WHO PRODUCE AN PROCESS THEIR FOOD -- AND PROCESS THEIR FOOD.
01:38:15 WE DON'T WANT TO THROW UNDUE PAPERWORK ON THOSE FOLKS, THEY DON'T HAVE THE ABILITY TO DO IT, IT TAKES THEM OUT OF THE FIELD TO DO THAT.
01:38:22 AND, QUITE HONESTLY, AS THEY MOVE FORTH, THE CONSUMER AND THE CONNECTION WITH THAT CONSUMER MAKES IT SO THAT LOCAL ENTITIES CAN DO THAT REGULATION MUCH BETTER THAN US ANYWAY.
01:38:36 WE'VE BEEN OVER A PRETTY LONG ROAD HERE OVER THE LAST MANY MONTHS.
01:38:43 I VERY MUCH APPRECIATE THE WORK THAT REPRESENTATIVE DINGELL HAS DONE IN THE HOUSE ON THIS BILL.
01:38:49 I VERY MUCH APPRECIATE THE WORK THAT WAS DONE ON -- ON MY AMENDMENT OVER HERE, KAY HAGAN IN PARTICULAR, THE GREAT SENATOR FROM NORTH CAROLINA, WORKED CLOSELY WITH ME ON THIS AMENDMENT AND HER INPUT WAS INCREDIBLY VALUABLE.
01:39:05 I ALSO WANT TO THANK SENATOR MERKLEY AND THE WORK HE DID ON THE AMENDMENT.
01:39:08 I WANT TO THANK THE CONSUMER GROUPS OUT THERE WHO I THINK WE FOUND A COMMONSENSE SOLUTION TO THIS ISSUE.
01:39:14 AND -- AND MANY OF THE ORGANIZATIONS OUT THERE THAT WE WORK WITH OVER THE LAST MANY MONTHS TO MAKE SURE THIS BILL MEETS THE NEEDS OF THE PEOPLE TO MAKE SURE THAT -- THAT WE DO ADDRESS THE ISSUE OF FOOD-BORNE ILLNESSES AND SAFE FOOD, BUT, YET, ALLOW THE LITTLE GUYS TO GROW, EMPLOY PEOPLE, AND ALLOW THAT ECONOMY TO GET BIGGER AND BETTER AS TIME GOES ON.
01:39:42 SO, WITH THAT, I WANT TO THANK YOU, MADAM CHAIR WITH THE BILL.
01:39:45 OPPORTUNITY TO VISIT ABOUT THIS LIKE I SAID, IT'S A VERY GET DONE.
01:39:48 IMPORTANT BILL THAT WE NEED TO I THINK IT MAKES SENSE FOR THIS COUNTRY AND IT MAKES SENSE FOR PEOPLE IN AGRICULTURE.
01:39:53 THANK YOU VERY MUCH.
01:40:00 I YIELD THE FLOOR AND -- I REQUEST THE ABSENCE OF A QUORUM.