Legislation pending in the Senate could help bring long-awaited reforms to the U.S. Food and Drug Administration
The statistics are grim. Each year in the U.S., food borne illness affects 76 million people, leading to 300,000 hospitalizations and 5,000 deaths, according to the U.S. Food and Drug Administration estimates.
And, federal inspections of food manufacturing facilities have been on the decline.
A report published earlier this month by the FDA's Office of the Inspector General found that, “between fiscal years 2004 and 2008, FDA inspected annually an average of 24 percent of the food facilities subject to its inspection. Except for a few instances, there are no specific guidelines that govern the frequency with which inspections should occur. Further, the number of food facilities that FDA inspected declined between FYs 2004 and 2008, even as the number of food facilities increased.”
In addition, the OIG found that 56% of U.S. food facilities have gone at least five years without an FDA inspection at all. And, the number of facilities that received “official action indicated” (OAI) classification after inspection — meaning inspectors found violations significant enough to initiate court proceedings to correct the problem — declined from 614 in 2004 to 283 in 2008.
The OAI classification itself is becoming a formality. In 2007, 36% of facilities that received this classification were essentially let off the hook. No one from FDA returned to reinspect the facilities, and no further action was taken. Several of these facilities refused to give FDA access to their records. The report blames the lax inspections and enforcement on declining staffing levels, but also notes that the agency does not have statutory to impose civil penalties on food processors that fail inspections and do not correct the problem.
Clearly, something must be done to correct this situation, and fortunately, it looks like help could be on the way, with legislation pending in the U.S. Senate.
Last July, the U.S. House of Representatives passed the Food Safety Enhancement Act of 2009, and the Senate is expected to debate the bill's companion legislation, the Food Safety Modernization Act, very soon. Several key provisions of these bills are very similar, so if the Senate passes its version in current form, the conference committee reconciliation process should be straightforward. Once the two houses agree on a final version of the legislation, it can be sent to President Obama to be signed into law.
The law would basically expand the FDA's regulatory powers, giving the agency the option to suspend the registration of a food facility, and the authority to order food recalls. It would also allow the agency to assess and collect fees related to food facility reinspection, food recalls and the voluntary qualified importer program.
Food producers will also be required to evaluate hazards within their facilities and implement preventative controls, such as a Hazard Analysis and Critical Control Point (HACCP) program. Currently, these programs are required only for food production facilities that process seafood and juice.
Although the law would lead to increased oversight and additional inspections, most of the industry's major trade groups have been supportive of the legislation, citing its necessity.
In January, the Produce Marketing Association, the National Restaurant Association, the Grocery Manufacturers Association, and the Food Marketing Institute joined with 14 other groups to send a letter to Congress urging quick action on the bill.
The letter stated that “strong food-safety legislation will reduce the risk of contamination and thereby better protect public health and safety, raise the bar for the food industry, and deter bad actors. S. 510 will provide the [FDA] with the resources and authorities the agency needs to help make prevention the focus of our food safety strategies. Among other things, this legislation requires food companies to develop a food safety plan; it improves the safety of imported food and food ingredients; and it adopts a risk-based approach to inspection.”
Opposition to the bill has come primarily from independent farmers and other small producers, who are concerned that a new law designed for large, commercial operations would place undue burdens on small farms.
“Food safety is a priority for us all, but the requirements of the Senate bill will impose significant expenses and burdens on small farmers and food processors that could well put them out of business,” said Judith McGeary, president of the Austin, Texas-based Farm and Ranch Freedom Alliance, in a release issued last week.
While praising the primary goals of the legislation, Senator Jon Tester, D-Mont., this month introduced amendments to the bill that would exempt processors with gross incomes of less than $500,000 per year, as well as producers who sell their food direct-to-consumer via farmers markets or community supported agriculture programs, for example.
“Let's face it, dangerous food-borne outbreaks don't start with family agriculture,” Tester said on his Senate website. “Food produced on that scale shouldn't be subject to the same expensive federal regulations as some big factory that mass produces food for the entire country.”
Sen. Tester may have a point — farmers markets haven't been implicated in the multi-state outbreaks and lapses in oversight that the new law would hope to address. But, the alarm that many small growers are expressing about the law is probably misplaced. With regard to food safety inspections, the FDA has become an underfunded agency that lacks real enforcement powers. If passed, this new law would simply help restore the agency's authority in these matters and help it start to rebuild.