The Food and Drug Administration (FDA) is under-resourced, under-staffed, and essentially incapable of overseeing potential threats to the US food supply, according to a former FDA official who last week opposed the National Uniformity for Food Act at a Senate hearing.
Recently retired William Hubbard, who spent 33 years in federal service, said he has been repeatedly involved in the issue of national uniformity for food safety laws over the years.
And according to him, implementing the National Uniformity for Food Act at the present time would replace a federal/state partnership that effectively monitors the nation's food safety with an impractical, ineffective system that would create a "vacuum in safety oversight".
Hubbard was speaking at a hearing of the Senate Committee on Health, Education, Labor and Pensions (HELP) last Thursday. The event was designed to examine the support and opposition for the proposed bill, which could standardize warning labels and food safety requirements throughout the US.
The bill, also known as S. 3128, was approved in the House of Representatives in March and is now due to be considered by the Senate.
But Hubbard painted a picture of an FDA regulatory structure that is incapable of meeting the nation's growing demands to oversee food production, food additives, dietary supplements, nutrition labeling, foods produced from biotechnology, foodborne disease outbreaks and dangerous new pathogens that infect food.
He stated that in 1972, around half of FDA's resources were allocated to its food program. Today, that figure has fallen to about one-quarter, even though the agency has little more staff than it had in the 1970's.
He also pointed out that 34 years ago FDA conducted 35,000 inspections of food manufacturing facilities. This year, he said, it will conduct around 5,000.
Another example he used was the volume of food imports from overseas, which is approaching 10 million per year. But the number that FDA inspectors physically examine is in the single digit thousands, according to Hubbard, making it virtually certain that any given food shipment will enter the US with no FDA inspection.
In contrast, the current system of state and federal collaborations has worked relatively well, he told the committee.
"There certainly has not been the sort of mass conflict and confusion that would warrant a fundamental undermining of the strong federal/state partnership that currently exists. And the states have served the valuable function at times of being the first to identify a health risk and, through their actions to protect their own citizens, have alerted the FDA, so that it could extend such protections nationally," he said.
"Yet S. 3128, in the name of 'uniformity,' would remove FDA's partner in protecting against food adulteration, and throw even more responsibilities at the agency-in effect, moving problem solving from a source that has proven to be an effective complement to Federal authorities to one that cannot accept more responsibility and will thus be ineffective," he added.
Hubbard also claimed that the provision in the bill that allows for states to petition the FDA to adopt an existing state standard as the national standard is "simply impractical".
According to the Congressional Budget Office, the FDA would receive at least 200 state petitions during the first year after the bill's enactment, and it would cost $400,000 to review each petition, he said. This would mean that the FDA would be required to spend$80 million to answer those petitions- "for no discernible public health gain."
"Mr. Chairman, the entire budget for salaries and expenses of the scientists in FDA's headquarters food program is under $100 million, so this bill, if enacted, wouldessentially mean that the food program would need to cease all other functions except forthe review of state petitions, if it were to make a sincere effort to comply with Congress'scharge," Hubbard said.
He added that the FDA has "shown demonstrably that resource constraints prevent it from processing the flow of citizen petitions that it currently receives."
Hubbard concluded his address by stressing the FDA's "absolute inability to implement this bill in any reasonable fashion."
"When a well resourced FDA has been able to examine a potential health risk in food, bringing to bear the best scientific data and analytical ability, and resulting in the establishment of a reasoned determination (…) it would be reasonable to consider whether that determination should be dispositive for the entire nation, and whether states should second guess such a carefully reasoned disposition."
"However, until and unless FDA is given the resources and ability to deal with any and all questions about the safety of food constituents, I believe that the existing federal/state cooperative relationship has passed the test of time in its effectiveness and ability to work together to protect our citizenry."
Other speakers at the hearing included William Stadtlander, the owner of Homestat Farm, which manufactures the 'healthy' cereal product Wheatena, and who was sued under California law because his product contains acrylamide.
Peter Hutt, senior counsel at Covington and Burling law firm also addressed the Committee, expressing his support for the bill and outlining its main features.
For the FoodNavigator-USA.com article on the hearing, click here.
For coverage of the address by Stadtlander, click here.
For coverage of the address by Hutt, click here .