President Obama is expected to sign a sweeping food safety bill into law today, marking the end of a lengthy legislative drama and turning the focus to whether the U.S. Food and Drug Administration will get the additional funding needed to implement the bill.

On the heels of a Tea Party-fueled midterm election, House Republicans have pledged to use their new majority to rein in federal spending and decrease the size of the bureaucracy–a tough environment for any government agency seeking greater resources.  Rep. Jack Kingston (R-GA), a fiscal conservative who will chair the subcommittee that oversees FDA’s budget, recently raised serious questions about the justification for the new food safety bill’s price tag.  The Congressional Budget Office estimates the new provisions will cost $1.4 billion over five years.

“I would not identify it as something that will necessarily be zeroed out, but it is quite possible it will be scaled back if it is significant overreach,” Kingston told the Washington Post in late December.  “We still have a food supply that’s 99.99 percent safe. No one wants anybody to get sick, and we should always strive to make sure food is safe. But the case for a $1.4 billion expenditure isn’t there.”

FDA Commissioner Margaret Hamburg told reporters on a White House media call Monday that she remains “optimistic” that the agency will be able to move forward and implement the bill, but declined to say whether the entire CBO estimate would be critical to carrying out all of the new responsibilities.  Those tasks include mandatory recall authority, increased inspection frequencies of high-risk facilities, and enforcing new requirements that growers and food facilities have food safety plans and that foreign facilities importing food to the U.S. must meet the same standards.

Shifting the federal food safety system, which haphazardly oversees a now global food system, from a reactive to a preventive system that enforces food safety regulations and inspects food facilities more than once a decade is no small feat.

“This is a major, historic piece of legislation … and it’s really Congress asking us to build a whole new system for food safety with all of the elements that you’ve been hearing about, some of those elements we’ve already been working on and will be able to put in place fairly quickly with existing resources.  Other components will require additional resources, dollar and human resources,” said Hamburg.   “We will be working closely with Congress and key stakeholders to try to really specify some of those needs.”

“Obviously the money that we have available in the annual budget cycle … ultimately impacts the way we are able to implement the bill,” said Hamburg, adding that FDA has been “very fortunate” to receive recent budget increases in recent years despite tough budgetary conditions.

When asked about Kingston’s comments about justifying the cost of implementing the bill,  Hamburg said that shifting the food safety system toward being preventive was “the appropriate way to go” and that the cost of not implementing the reforms would be “simply unacceptable.”

“We are very fortunate that we do have one of the safest food supplies in the world, however, every day we see preventable illness.   We see unnecessary hospitalization and too many people have died from foodborne disease that could have been prevented,” said Hamburg. “We are committed to taking on these new responsibilities and mandates given to us by Congress and we will work closely with Congress to implement this as efficiently and effectively as possible.”

Secretary of Health Kathleen Sebelius, also on the media briefing, called on Congress to fund the bill.

“The change won’t happen overnight and it’s still essential that Congress provide sufficient funding for these improvements to take shape,” she said.  “Thanks to the legislation, we can seriously begin building the 21st century food safety system that we desperately need.”

Advocates for the new law, including consumer lobbyists and the leading food industry groups, are gearing up to fight for the funding.

“FDA is going to need the resources to enable this landmark new law to fulfill its promise.  The costs of not implementing this new law are staggering,” said Erik Olson, director of food initiatives for the Pew Health Group, citing a study last year that estimates the total health care costs for foodborne illness at $152 billion annually.

“Those costs dwarf any costs of implementing costs for this legislation,” added Olson. “That doesn’t even consider the costs to industry of these recalls.  A single company announced, back in 2009, that the peanut recall alone cost them $60-70 million.  This will save a great deal of money for consumers and industry.”

Olson said consumer, industry, public health, and foodborne illness victim lobbying groups are all set to “vigorously” make the case for funding the new provisions.  “This is money that is extremely well spent.  It’s wise to spend money in order to save money in the long run.  We will be seeking to make the case to Congress that it is important to public health.”

Pam Bailey, president and CEO of the Grocery Manufacturers Association, a strong supporter of the bill, said the food industry “has long recognized that strong government oversight is a critical and necessary part of our nation’s food safety net” and pledged GMA’s continued support for successfully implementing the new law.

Bailey said that the food sector expects the reforms will prevent contamination and “raise the bar for the entire industry.”

President Obama is expected to sign the FDA Food Safety Modernization Act into law today when he returns from a family vacation in Hawaii.  The signing will likely be low key.  As of publication time, the signing was not on the president’s official schedule and White House aides have indicated there will not be a formal bill signing ceremony.

  • Instead of talking about the cost of implementing the bill they should do more to eliminate its imperfections such as the right to inspect the producers regardless of whether a law has been broken or not.

  • DCG

    This legislation misses the vital ingredient of any real “risk-based” approach which is purportedly its basis. The assessment of food safety risk – normally the likelihood of contamination coupled with the severity of the pathogen – is not apparent in the new regulations. In the end the Bill does nothing to foment development of private sector capacity to improve food safety.
    As the rest of the World embraces voluntary standards and private 3rd party verification to encourage “better agricultural practices” and food safety systems through market-based incentives, the US seems compelled to regulate its way out of the unique and broken system it has created.
    By consolidating its regualtory apparoach and leaving execution to “duly authorized representatives of the Secretary” (e.g. regulators) farmers and processors will now have to absorb the additional costs of carefully documenting their practices as well as the public’s risks. It would seem that small farmers selling into local markets – conventional or organic – now have exactly the same risk profile as large interstate factory farms.
    It is very unclear how this legislation meets up to its name or that it will do anything other than further advance farm and processing consolidation and ultimately increase the risk of catastrphic food-based calamities.

  • dangermaus

    I wonder what current percentage of the FDA’s (non-drug) budget is for administration vs. actual inspectors.
    One thing about FSMA that did seem to make some sense to me, more funding for more frequent inspection of (interstate, industrial-scale) producers, but I guess it’s possible that they’re spending a larger portion than necessary of their money in offices in Washington, instead of actually inspecting.

  • Michael Bulger

    There’s risk assessment in several places within the law. For example:
    “(i) IN GENERAL.—In promulgating
    the regulations under subparagraph (A), the Secretary shall consider the results of the science-based risk analysis conducted under subparagraph (C), and shall exempt certain facilities from the requirements in section 418 of the Federal Food, Drug, and Cosmetic Act (as added by this section), including hazard analysis and preventive controls, and the mandatory inspection frequency in section 421 of such Act (as added by section 201), or modify the requirements in such sections 418 or 421, as the Secretary determines appropriate, if such facilities are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities that the Secretary determines to be low risk involving specific foods the Secretary determines to be low risk.”
    “‘‘(4) PRIORITIZATION.—The Secretary shall prioritize the implementation of the regulations under this section for specific fruits and vegetables that are raw agricultural commodities based on known risks which may include a history and severity of foodborne illness outbreaks.”
    “(e) AUTOMATED RISK ASSESSMENT.—The report developed under subsection (a)(1) shall include a description of progress toward developing and improving an automated risk assessment system for food safety surveillance and allocation of resources”
    There are plenty more examples. Try reading through it again.