Christopher Doering, Gannett Washington Bureau
WASHINGTON -- With thousands of Americans falling ill and public confidence shaken after a series of high-profile foodborne outbreaks several years ago involving consumer staples such as lettuce, peppers, peanuts and eggs, Congress and the White House moved aggressively to bring food safety into the 21st century.
But two years after President Obama signed a sweeping food safety bill into law, the rules at the heart of the largest food safety overhaul in more than 70 years have yet to be put in place, blocked by their sheer length, growing complexity and a White House that critics contend has delayed their implementation for political gain.
At the same time, the Food and Drug Administration, the government agency charged with implementing the new law, has been the victim of a push in Washington to rein in spending and some Republicans in Congress who have questioned the necessity and cost of the regulations.
FDA Commissioner Margaret Hamburg said in October that unless the agency's food safety budget is increased by millions of dollars from its current level of $1.2 billion it would continue to struggle to implement the expansive new regulations. "Implementing that broadly expansive mandate with limited resources has been a challenge," Hamburg said at an event hosted by the Center for Strategic and International Studies, a think tank. "It has been harder and slower than any of us would have wanted."
The longer it takes the food laws to be enacted, proponents of the law argue, the more time the country's food supply remains exposed to an unnecessarily high level of risk. They point to the example this fall of Salmonella found at a Sunland Inc. peanut butter
processing plant in New Mexico that caused 42 people, mostly children, in 20 states to become ill. The facility had a history of food safety violations.
"The Obama administration has already seen a number of very serious outbreaks while we have been waiting for these rules to be released," said Caroline Smith DeWaal, food safety director with the Center for Science in the Public Interest. "The cost of delay is really the likelihood that more people will get sick and some may get seriously ill, may end up in the hospital and some could even die while we're waiting for these rules to be finalized."
Foodborne illnesses strike an estimated 48 million people in the United States each year, or about one in six Americans, killing 3,000, according to data from the U.S. Centers for Disease Control and Prevention. A study released in 2010 by consumer and public health groups said foodborne diseases cost the United States $152 billion in health-related expenses each year, far more than prior estimates. Despite the outbreaks, the United States is widely regarded as having one of the safest food supplies in the world.
The Food Safety Modernization Act signed into law by President Obama in January 2011 marked the biggest change of U.S. food safety laws since 1938 when Congress gave the FDA authority to oversee the safety of food, drugs and cosmetics.
For years, the FDA, tasked with regulating 80 percent of the U.S. food supply, was widely seen by lawmakers, consumer groups and the agency itself as understaffed and underfunded. That leaves the agency able to inspect only of a fraction of the plants under its watch.
A handful of power-boosting rules went in place immediately after Obama signed the new law. Among the most prominent were regulations that:
Gave the FDA access to documents at a food company tied to an illness or death
Increased the frequency of plant inspections
Gave the agency the power to order a mandatory recall
Allowed the FDA to suspend a company's operation's "" something the agency did last month in the case of Sunland.
But implementation of other measures -- such as requiring food production facilities to have a plan in place to identify and prevent contamination along with stricter requirements for overseeing the production and harvesting of fresh produce -- are months behind. Tougher oversight of imported foods also has been delayed. The law requires importers to verify the food they bring into the United States meets domestic safety standards. The food could be denied entry if it fails to do so.
The produce rule, for example, has been besieged with criticism that it was poorly written, and an insufficient job was done analyzing the costs and benefits for producers. All this has caused the rule to swell in excess of 700 pages, likely contributing to its subsequent delay, according to those who follow the food safety legislation.
"It is a broader ranging bill than Congress thought it passed," said Chad Hart, an associate professor of economics at Iowa State University. "Once you begin to look at the agricultural production and transport systems here in the U.S. that's a mammoth task so it doesn't surprise me that it's taken quite a while."
Rep. Kristi Noem, a South Dakota Republican and a member of the House Agriculture Committee, was sympathetic to the complexity of the rule-making process required to implement the new regulations. A host of factors must be considered such as if the measures are needed, how much they will cost and the degree to which they will impact food delivery and safety. Still, she said: "Two years "¦ is too long not to come forward with rules and regulations especially when it is as important as food safety."
The FDA submitted them to the White House's Office of Management and Budget in late 2011 for approval, but the administration has yet to sign off on them. Once the OMB gives the okay, implementation of the food safety laws is likely still several years away. The public must first be given the chance to comment on the proposals before the FDA can incorporate their suggestions into the final rules. After that, larger companies are usually given a year to comply with the new measures with smaller businesses having three years.
The White House referred questions on the food safety rules to the OMB. Moira Mack, a spokeswoman with the OMB, said the Obama Administration remains committed to food safety, citing a rule enacted to crack down on salmonella in eggs and the expansion of E. coli testing for beef. "We are working as expeditiously as possible to implement the food safety legislation we fought so hard for," said Mack. "When it comes to rules with this degree of importance and complexity, it is critical that we get it right."
Even if the rules went into effect on time it's unlikely they would have been able to prevent recent major recalls. David Acheson, the FDA's former food safety czar, said it takes time before companies can make the necessary changes that will have a noticeable effect on public health. "The change does not move that quickly. They are going to take a long time before they have an impact," he said.
Acheson, food safety groups and others said the administration should release the proposed rules so the public and businesses affected by them could comment. They put the blame directly on the White House, which they claim likely delayed releasing the proposed rules before the election amid fears that higher costs imposed on companies would be passed on to consumers. "It's time to stop playing with them just get them out there, warts at all, and have at it," said Acheson, who is now a partner at Leavitt Partners and oversees the firm's food and import safety practice.
"There is a high level of frustration in the (FDA) about this and they genuinely believe these things are ready to go," said Acheson. "I believe the holdup is political and thus by process of elimination sits at the White House door and ultimately with the president."
The FDA has not been the only consumer protection agency to have its regulatory arsenal strengthened by Congress in recent years.
After a series of highly publicized recalls involving lead-painted toys from China, lawmakers passed a law in August 2008 to strengthen the Consumer Production Safety Commission. The new law increased its budget and staff, imposed stiffer testing and product labeling requirements on businesses and established thresholds for several substances such as lead and chemicals called phthalates that are found in plastics and have been linked to birth defects in lab animals. Businesses that violated the law were slapped with higher fines and in some cases jail time.
In the last four years, the CPSC, which is responsible for monitoring more than 15,000 types of products, has seen the number of recalls drop for items it oversees from 107 in the quarter when the law was passed by Congress to 70 in the third-quarter of 2012, according to data from Stericycle ExpertRECALL, an Indianapolis-based firm that has provided advice and helped major U.S. companies carry out recalls. Meanwhile, the FDA, without its full arsenal of funding and enforcement tools, has seen recalls rise from 113 recalls in the first quarter of 2011 when the Food Safety Modernization Act was signed to 169 in the second quarter of this year, a 50 percent increase.
Gale Prince, a consultant for Stericycle ExpertRECALL, said companies affected by the CPSC rules have had more time to adopt and implement the new regulations in their business operations. "It's the difference in maturing of the legislation," said Prince. "The awareness of the activity of the CPSC has had an effect, they have gotten the word out and I think that may be part of the downward trend."
While some businesses are waiting until the food safety rules are published, many companies are already incorporating their own food safety handling and transportation measures into their operations. The threat of potential litigation, long-term damage to their brand and a surge in the use of social media tools by the public to communicate has put more pressure on businesses to meet or exceed existing food safety requirements, said Acheson.
Hy-Vee, the 234-store, West Des Moines-based grocery chain has hired an outside auditor to do inspections of its stores. It also has worked with its distribution centers to make sure they handle and transport food using the same standards, such as ensuring sanitary conditions and uniform temperatures are maintained.
"There is cost involved but it's a cost of doing business and certainly it's nothing compared to not doing it," said Ruth Comer, assistant vice president of media relations with Hy-Vee. "If something isn't done and there is a food borne illness outbreak or another situation that one incident could be far more costly than any protective measures."
Contact Christopher Doering at firstname.lastname@example.org
Gannett Washington Bureau