Currently browsing posts about: GAO(Government Accountability Office)

The Government Accountability Office is complaining again about the inadequacies of the American food safety system, and with good reason.

Its 2012 Annual Report, Opportunities to Reduce Duplication, Overlap and Fragmentation, Achieve Savings, and Enhance Revenue, says that the food safety system is:

fragmented and results in inconsistent oversight, ineffective coordination, and inefficient use of resources.

In 2007, GAO added food safety to its list of high-risk areas that warrant attention by Congress and the executive branch.

More recently GAO found that this fragmentation extends to the responsibilities across multiple agencies to defend food and agricultural systems against terrorist attacks and natural disasters…Many of these activities are everyday functions or part of the broader food and agriculture defense initiative and would be difficult for the agencies to separately quantify.

This report repeats what the GAO has been saying since the early 1990s:

there is no centralized coordination to oversee the federal government’s overall progress in implementing the nation’s food and agriculture defense policy.

Because the responsibilities outlined in this policy (HSPD-9) are fragmented and cut across at least nine different agencies, centralized oversight is important to ensure that efforts are coordinated to overcome this fragmentation, efficiently use scarce funds, and promote the overall effectiveness of the federal government.

Reminder: the present food safety system is mainly divided between two agencies: USDA (meat and poultry) and FDA (everything else).

Centralized oversight of food safety?  What a concept.

Politics does indeed make strange bedfellows. 

The American Enterprise Institute, a conservative (to say the least) think tank, has just issued a report on reforming the farm bill to ensure a safer food system.  Its stunning conclusion:

More feasibly, in the short to medium term, changes in food safety regulation should aim at correcting inconsistencies or loopholes that exist in US food safety laws.

For example, policymakers could merge the FSIS and the FDA to allow for a better allocation of resources and exploit potential return to scales.

Standardizing states’ detection systems for food-borne illnesses and collecting better data about the incidence of food-borne illnesses would make firms more accountable and help construct better food safety policies.

Merge the food safety functions of USDA and FDA?  This, of course, is precisely what food safety advocates and the Government Accountability Office have been urging since the early 1990s. 

Now, maybe, it has a chance?

According to rumors passed along by Dan Flynn at Food Safety News via the Hagstrom Report (an agricultural subscription news service costing $999 a year), the Office of Management and Budget wants to merge federal agencies, among them the food safety components of FDA and USDA.

Rumors are that the Obama administration wants to do this to make “food safety independent of USDA, which primarily exists to market and promote American farm products.”

If this happens, it could be one major benefit of cost-cutting measures.  At the moment, USDA gets about three quarters of the total appropriation for food safety (for roughly one quarter of the food supply) whereas FDA gets one quarter of the appropriation for three quarters of the food supply.

This inequity is a result of the way Congress funds the FDA—through agricultural appropriations committees, not, as any sensible person might expect, through health committees (this too needs to change).

The merger also would eliminate the dysfunctional distinctions between regulations for meat and poultry (USDA) and practically all other foods (FDA).   A merged agency could deal with the unpleasant fact that animal waste is the cause of many food safety problems with fruits and vegetables.

The idea of a single food safety agency is not new.  The Government Accountability Office (GAO) has been calling for its creation since 1990 or earlier, most recently in 2011.

In the 2011 report, GAO said, as it has for years:

Fragmented food safety system has caused inconsistent oversight, ineffective coordination, and inefficient uses of resources…The Department of Agriculture’s (USDA) Food Safety and Inspection Service and the Food and Drug Administration are the primary food safety agencies, but 15 agencies are involved in some way.

These, GAO points out, administer at least 30 food-related laws.

In addition, GAO urges Congress to ask the National Academy of Science to consider several organizational structures that might work better than the current system:

• A single food safety agency, either housed within an existing agency or established as an independent entity, that assumes responsibility for all aspects of food safety at the federal level
• A single food safety inspection agency that assumes responsibility for food safety inspection activities, but not other activities, under an existing department, such as USDA or FDA
•  A data collection and risk analysis center for food safety that consolidates data collected from a variety of sources and analyzes it at the national level to support risk-based decision making
• A coordination mechanism that provides centralized, executive leadership for the existing organizational structure, led by a central chair who would be appointed by the president and have control over resources

The rumors do not say which of these options is favored.

Not everyone is as enthusiastic about a single food safety agency as I am, in part because this and other issues remain to be resolved: where the new agency would go and what its resources might be.

And, as food safety lawyer Bill Marler points out, legal matters are also at stake:

We can’t overlook the legal issues in food safety. Right now there are too few legal consequences for sickening or killing customers by selling contaminated food. We should impose stiff fines, and even prison sentences, for violators, and even stiffer penalties for repeat violators.

So, let’s make some progress in stopping food poisoning and then later pick out the new stationery.

Former USDA official Richard Raymond, writing in Food Safety News argues:

It is my sincere belief that a merger of the two food safety agencies would be an unmitigated disaster in the short term because the cultures are so very different. And unless megadollars flowed with the merger, nothing more could be accomplished than is currently done.

And there are dozens of other valid reasons to “just say no” to the Administration’s thinking.

He suggests reading the comment posted on Dan Flynn’s article from Carol Tucker Foreman, also a former USDA official and a long-time food safety advocate.

The major point of her very long comment is that moving USDA’s meat and poultry inspection responsibilities to FDA

Would likely reduce the current level of health protection provided by food safety laws and curtail the progress that has been made in reducing foodborne illness.

The FDA, saddled by lack of funds, sufficient legal authority, and food safety leadership has been criticized…for its inability to provide a decent level of food safety protection in the domestic and imported food products it regulates.

…Today the FSIS [USDA] has surpassed the FDA in some areas. The agency has adequate resources and high official status in a relatively small Cabinet agency…FDA, despite its new law, is still strapped for funds, burdened by its low position at HHS and the need to manage multiple agendas…Reorganization would not address the continuing problems of either agency.

…We’re confident that trying to move other agencies to the FDA or HHS won’t save money. In fact we are confident it would reduce the effectiveness of the meat and poultry inspection program…leading to a potential increase in foodborne illness and the related costs. That makes it bad policy and a bad bargain.

But what if the new hypothetical single food safety agency does not go to FDA?  What if it goes someplace independent of either agency?   And what if the new entity started out with the highest possible safety standards, funded adequately?

If we are dealing with rumors, we can deal with dreams too, no?

Update, January 29:  Food SafetyNews says all rumors are false.  This isn’t going to happen because the meat industry doesn’t want it to happen.

The Government Accountability Office (GAO) recently released a tough report on the FDA’s dispute with the Gulf Coast shellfish harvesting industry about oyster safety: Food Safety: FDA Needs to Reassess Its Approach to Reducing an Illness Caused by Eating Raw Oysters.

To better ensure oyster safety, says GAO, FDA should work with the oyster industry to (in my paraphrase):

• Agree on a nationwide goal for reducing the number of illnesses caused by the consumption of Gulf Coast raw oysters
• Develop strategies to achieve that goal
• Recognize that consumer education and time-and-temperature controls have not worked
• Recognize that the capacity to use postharvest processing methods does not currently exist.

As I explain in my book, Safe Food: The Politics of Food Safety, the FDA for more than a decade has been trying to prevent deaths caused by Vibrio vulnificus bacteria that contaminate raw oysters grown in the Gulf of Mexico.

These “flesh-eating” bacteria proliferate in warm months and are especially deadly; they kill half of the thirty or so people who develop infections from it each year.

In 2001, the oyster industry trade association, the Interstate Shellfish Sanitation Conference (ISSC), promised the FDA that this industry would substantially reduce Vibrio infections in oysters within seven years through a program of voluntary self-regulation and education aimed at high-risk groups.

If this program failed to reduce the infection rate, the ISSC agreed that the FDA could require oysters to be treated after harvesting to kill pathogenic Vibrio.

Postharvest processing involves techniques such as quick freezing, frozen storage, high hydrostatic pressure, mild heat, or low dose gamma irradiation, any of which reduces Vibrio vulnificus to undectable levels.

By most reports, the effect of treatment on the taste and texture of oysters is slight (although raw oyster aficionados might argue otherwise).

The California actions are instructive: In 2003, California refused to allow Gulf Coast oysters from entering the state unless they had undergone postharvest processing.  The result?  Sales of oysters remained the same but oyster-related deaths dropped to zero!

In contrast, states that did not require postharvest processing experienced no change in the number of deaths, meaning that the ISSC program had failed.

Late in 2009, the FDA announced that it intended to issue rules requiring postharvest processing of Gulf Coast oysters in summer months.

But less than a month later, the FDA backed off.  Under protest from Gulf Coast oyster harvesters, state officials, and elected representatives, the FDA agreed to postpone the oyster-processing rules indefinitely.

As the GAO understates the matter,

FDA and the ISSC do not agree on a common V. vulnificus illness reduction goal….If FDA and the ISSC are not in agreement on the illness reduction goal and strategies to achieve it, it will be difficult for the Gulf Coast states to move forward to significantly reduce the number of consumption-related V. vulnificus illnesses.

The GAO report further explains:

the ISSC continues to include California’s results in its illness rate reduction calculation along with Florida, Louisiana, and Texas. Doing so overstates the effectiveness of consumer education and time and temperature controls….

My translation: Despite years of warnings and promises that it has no intention of meeting, the Gulf oyster industry has been able to stave off FDA regulations for ten years at the expense of about 15 preventable deaths a year.

This is yet another example of political pressures blocking the FDA from carrying out its mandated food safety responsibilities.

Let’s hope the GAO report induces Congress to push this industry to get its act in order and the FDA to issue those regulations.

FDA’s program is generally limited to enforcing the Hazard Analysis and Critical Control Point—the internationally recognized food safety management system—by conducting inspections of foreign seafood processors and importers each year.

These inspections involve FDA inspectors reviewing records to ensure the processors and importers considered significant hazards, including those resulting from drug residues if the seafood they receive are from fish farms.

The inspectors generally do not visit the farms to evaluate drug use or the capabilities, competence, and quality control of laboratories that analyze the seafood.

• Aquaculture assessments have been limited by FDA’s lack of procedures, criteria, and standards. In contrast, the EU reviews foreign government structures, food safety legislation, the foreign country’s fish farm inspection program, and visits farms to ensure that imported seafood products come from countries with seafood safety systems equivalent to that of the EU.
• FDA’s sampling program does not generally test for drugs that some countries and the EU have approved for use in aquaculture. Consequently, seafood containing residues of drugs not approved for use in the United States may be entering U.S. commerce.
• FDA’s sampling program is ineffectively implemented. For example, for fiscal years 2006 through 2009, FDA missed its assignment plan goal for collecting import samples by about 30 percent.
• In fiscal year 2009, FDA tested about 0.1 percent of all imported seafood products for drug residues.
• FDA’s reliance on 7 of its 13 laboratories to conduct all its aquaculture drug residue testing raises questions about the agency’s use of resources.
• FDA has inspected 1.5 percent of Chinese seafood processing facilities in the last 6 years.

And Congress wants to cut FDA’s resources.  I have no doubt that the FDA could be more efficient but the scope of what it is expected to do with limited resources is beyond absurd.

From where I sit, the entire food safety system needs an overhaul and the problems with food imports are a good reason for doing that.

Just a couple of weeks ago, the Government Accountability Office (GAO), the congressional watchdog agency, issued a report calling for a single food safety agency (see my post on this). 

The GAO is working hard on this issue.  It has just issued yet another report, this one called FEDERAL FOOD SAFETY OVERSIGHT: Food Safety Working Group Is a Positive First Step but Governmentwide Planning Is Needed to Address Fragmentation.

The report points out some of the alternatives it has suggested in the past:

• A single food safety agency
• A food safety inspection agency
• A data collection and risk analysis center
• A coordination mechanism led by a central chair

GAO says:

GAO and other organizations have regularly paired proposals for alternative food safety organizations with calls for comprehensive, unified, risk-based food safety legislation.

New food safety legislation that was signed into law in January 2011 strengthens a major part of the food safety system; however, it does not apply to the federal food safety system as a whole or create a new risk-based food safety structure.

GAO recommends that the Director of OMB, in consultation with the federal food safety agencies, develop a governmentwide performance plan for food safety that includes results oriented goals and performance measures for food safety oversight and a discussion about strategies and resources.

As I have mentioned in previous posts, GAO has been making these kinds of recommendations for 20 years.  Does anyone in government listen?  This report notes that the Office of Management and Budget declined to respond to its recommendations.

Responsive government anyone?  This seems like a reorganization well worth trying.  We only have one food supply.  We should not need two agencies to manage its safety risks.

Thanks to FoodSafetyNews for the heads up on the latest Government Accountability Office(GAO) attempt to get Congress to consolidate federal food safety functions on one agency.

The GAO’s latest 345-page report on how the federal government can save money lists its proposals in alphabetical order by area.  Agriculture comes first and, therefore, so does food safety.  You have to love the way GAO titles its sections: “Fragmented food safety system has caused inconsistent oversight, ineffective coordination, and inefficient use of resources.”

GAO has been saying this for 20 years.  In 1990, for example, it published reports on who does what in the federal government about food safety and the inconsistencies in oversight.

As I wrote in Safe Food: The Politics of Food Safety (2010),

Today, an inventory of federal food safety activities reveals a system breathtaking in its irrationality: 35 separate laws administered by 12 agencies housed in six cabinet-level departments….

At best, a structure as fragmented as this one would require extraordinary efforts to achieve communication let alone coordination, and more than 50 interagency agreements govern such efforts.

Among the six agencies with the broadest mandates, all conduct inspections and collect and analyze samples, and at least three–though not necessarily the same ones–have something to do with regulating dairy products, eggs and egg products, fruits and vegetables, grains, and meat and poultry.

Until recently, the system had no mission statement (for whatever such statements are worth) and it still does not have consistent rules, clear lines of authority, a rational allocation of resources, or standards against which to measure success.

With such a system, some issues–such as use of animal manure to fertilize food crops—inevitably fall between the cracks and are governed by no rules whatsoever.

Not much has changed in the subsequent 20 years, as this new report attests.  As is inevitably the case, some of the areas of overlap are simply absurd:

The 2008 Farm Bill assigned USDA responsibility for catfish, thus splitting seafood oversight between USDA and FDA. In September 2009, GAO also identified gaps in food safety agencies’ enforcement and collaboration on imported food.

Specifically, the import screening system used by the Department of Homeland Security’s Customs and Border Protection (CBP) does not notify FDA’s or FSIS’s systems when imported food shipments arrive at U.S. ports.

But the worst is the situation with shell eggs, seemingly unfixable, given the 2010 recall of 500 million eggs:

FDA is generally responsible for ensuring that shell eggs, including eggs at farms such as those where the outbreak occurred, are safe, wholesome, and properly labeled and FSIS [USDA] is responsible for the safety of eggs processed into egg products.

In addition, while USDA’s Agricultural Marketing Service sets quality and grade standards for the eggs, such as Grade A, it does not test the eggs for microbes such as Salmonella.

Further, USDA’s Animal and Plant Health Inspection Service helps ensure the health of the young chicks that are supplied to egg farms, but FDA oversees the safety of the feed they eat.

I repeat.  This is not a new issue.  The hope was that the food safety act passed in January would pave the way to establish a single food safety agency.  The GAO report, while urging its creation, doubts that it will cut costs.

But it might save lives.

Let’s hear it for the Government Accountability Office, the congressional watchdog agency that has still managed to remain independent of the more corrupt aspects of Washington food politics.  In its most recent investigation, the GAO took a tough look at the inability of the FDA to hold health claims on food packages to reasonable scientific standards.

The new GAO report, Food Labeling: FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims, appeared on January 14.

The report reviews the history of health claims on food labels.  By law, these must be supported by “significant scientific agreement,” but court decisions in 2002 led the FDA to allow “qualified health claims.”  These claims have less—and, sometimes, no—scientific support.

Parke Wilde, who writes the U.S. Food Policy Blog, brilliantly parses the categories of health claims now allowed by the FDA:

• Health claims — aka REAL health claims — which must have evidence that meets a standard called “significant scientific agreement”
• Qualified health claims — aka WISHFUL health claims — which can meet a weaker standard of evidence, so long as the company admits the weaker evidence on the label.
• Structure / function claims — aka STEALTHY health claims — which purport not to be health claims (for example, a high-fiber product that “keeps your bowels moving” without explicitly claiming to “treat constipation”; or a high-calcium product that “builds strong bones” without explicitly claiming to “prevent osteoporosis”)

The GAO reviews evidence that consumers can’t tell the difference between one kind of health claim and another (I could have told them that).

Food companies take advantage of this confusion and increasingly use the stealth structure/function claims, which the FDA pretty much ignores.

The FDA has to ignore them.  It doesn’t have much choice.  The FDA has no authority to require companies to submit evidence of scientific substantiation.  The FDA is permitted to ask for the information, but it has no legal authority to force companies to provide it.

GAO says this situation does not sufficiently protect the public from unscrupulous marketers.  It says the FDA should:

• Ask Congress to grant it the authority to access companies’ evidence for the scientific support of potentially false or misleading structure/function claims on foods.
• Provide guidance to industry on the evidence it needs to support such claims.
• Provide direction to FDA inspectors to help identify claims for further review.

FDA: Do this, please, and right away.  Congress: Pay attention and act.

Imagine: health claims on food packages that actually have some science behind them.  What a concept!