Agribusiness and Governmental Oversight

In May, the Centers for Disease Control identified a nationwide increase in the number of salmonella cases documented in the United States.  Approximately three months later Wright County Egg voluntarily conducted a nationwide recall of shell eggs from three of its five farms. The recall was expanded to all Wright County Egg farms on Aug. 18. Two days later a second Iowa farm, Hillandale Farms, also issued a voluntary recall of shell eggs.

Both companies are currently working with the federal Food and Drug Administration (FDA) to help ensure no more Americans are impacted by salmonella; nearly 2,000 people contracted the illness prior to the issuance of the recall and the onset of the associated problem investigation.   While the question of what caused the contamination is obviously critical, no less important questions certainly must be, “Why did it take so long to identify the problem and issue recalls?” and “Did thousands of people fall ill unnecessarily due to food safety violations?”

As the current egg recall is a new addition to a long list of food recalls in recent years, the public and media have become increasingly concerned with the effectiveness of governmental oversight of agribusiness.  Margaret Hamburg, Commissioner of FDA, admits the agency is limited by law to a mostly reactive stance on food safety and argues that it needs a more “preventive approach.”

The Government Accountability Office (GAO) often referred to as “the investigative arm of Congress” is an independent, nonpartisan agency that works for Congress.  The GAO investigates how the federal government spends taxpayer dollars.   The GAO’s High-Risk Series of activities and reports is intended to raise the priority and visibility of government programs that are in need of broad-based transformation to achieve greater economy, efficiency, effectiveness, accountability, and sustainability.

These reports also help Congress and the executive branch carry out their responsibilities while improving the government’s performance and enhancing its accountability for the benefit of the American people.  In January 2007, as part of their regular update of the high risk series for each new Congress, GAO designated the federal oversight of food safety as a high-risk area for the first time.

The GAO noted that the federal oversight of food safety is fragmented, with 15 agencies collectively administering at least 30 laws related to food safety. The two primary agencies are the U.S. Department of Agriculture (USDA), which is responsible for the safety of meat, poultry, and processed egg products, and the Food and Drug Administration (FDA), which is responsible for virtually all other food.

The majority of federal expenditures for food safety inspection were directed toward USDA’s programs for ensuring the safety of meat, poultry, and egg products; however, USDA is responsible for regulating only about 20 percent of the food supply. In contrast, FDA, which is responsible for regulating about 80 percent of the food supply, accounted for only 24 percent of expenditures.

Among the reasons the GAO designated federal oversight of food safety as a high-risk area is the fact that the federal government’s limited control of the food recall process heightens the risk that unsafe food will remain in the food supply, ultimately being consumed.

Recalls of food product (as with drugs) are voluntarily carried out by private enterprises; federal agencies have no authority to compel companies to recall product  (with the exception of FDA’s authority to require a recall for infant formula) from the shelves.  The role of the USDA and FDA in the recall process is limited to providing guidance for companies conducting recalls, and to provide investigative expertise while trying to identify the root cause of the problem that caused the recall.

In that capacity, GAO also reports that the current system renders USDA and FDA unable to;

•    know how promptly and completely companies were carrying out recalls

•    verify that recalls had reached all segments of the distribution chain

•    verify the effectiveness of the recall procedures with regard to the notification of consumers

The fragmented nature of the federal food oversight system leaves little doubt that the government could plan more strategically to inspect food production processes, identify and react more quickly to outbreaks of contaminated food, and more effectively focus on promoting the safety and integrity of the nation’s food supply.

For instance, in addition to the inability to mandate recalls, the Code of Federal Regulations does not currently incorporate standards that would allow inspection of agribusinesses to result in a disposition of the compliance status of the food processing/manufacturing facility.  The FDA does publish guidance on practices meant to promote food safety and sanitation.  The standards within the guidance documents can be adopted by state and local governments but they are not requirements at any level of government.

New legislation, designed to respond to GAO concerns and create a more effective system, has been presented to Congress, and has received wide bipartisan support.  The Act, known as The FDA Food Safety Modernization Act, has unfortunately been delayed in Congress.

The FDA continues to publically encourage the passage of the Act because it will hold agribusiness more responsible for the safety of their product and strengthen federal oversight of the production process.
For example the new legislation will:

•    give the FDA the ability to mandate recalls

•    give the FDA the ability to conduct a greater number of inspections, in a more robust fashion

•    improve traceability of food distribution paths

•    federally require farms to immediately report any finding of unsafe food in their product of supply chain

•    allow the FDA access to records in the course of problem investigations

In the meantime, and in respect to the current contamination of the national egg supply, there is new legislation that is focused solely on egg products: The Egg Safety Action Plan or Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation, 21 CFR Parts 16 and 188l.

This new set of regulations was implemented in July 2009.5  Compliance deadlines for agribusiness are/were July 2010 (facilities with more than 50,000 hens) and July 2012 (facilities with between 3000 and 50,000 hens).  As a result of this legislation, FDA has been given the ability to inspect more than 4,000 farms to which they previously did not have access.

This regulation gives inspectors more authority and also implements biosecurity and pest control programs, environmental and egg testing requirements, and requirements concerning refrigerated storage of eggs at the farm.

The following is a list of examples of the new requirements that agribusiness producing eggs must comply with:

•    facility registration

•    federally mandated refrigeration specifications (i.e., production facilities will need to implement programs to monitor and control temperature, respond to temperature excursions and provide for product disposal as a result of loss of refrigeration control)

•    implementation of pest control programs

•    implementation of SE (Salmonella Enteritidis) plan including managerial role definitions, prevention measures, environmental monitoring , problem investigation and corrective action methods

•    implementation of documentation mechanisms that ensure producers can prove that young hens were SE-monitored or raised under SE-monitored conditions.

•    implementation of documentation mechanisms capable of demonstrating compliance with all requirements

The GAO report, the drafted Food Safety Modernization Act, and the new egg based legislation make it abundantly clear that the federal government is keenly aware of the limitations and weaknesses of its own systems.   While it is clear that improvements are slowly being made to these oversight systems, it is also clear that the pace of change is not contributing to the safety of the American consumer or the protection of the national food supply.

It is worth noting that the Quality System Regulations, under which many of our companies regulated by Title 21 function, require that a large number of data sources be constantly monitored in order to consistently improve process control.  These federally mandated monitoring programs would not be considered complete by the FDA unless they incorporated the review of the data by the officers in charge of decision making and a mechanism that required the leadership’s immediate and effective response.  The leadership’s response would not be considered acceptable unless it moved toward the improvement of the control systems (i.e. the systems meant to ensure safety and quality).

The American public should expect no less of their leadership.

•    On the topic of food safety, the government has evaluated itself and made the results of this evaluation available to the public in the form of the GAO report.

•    The results of that evaluation were considered and legislation drafted, supported by FDA and presented to Congress.

•    Now, more than three (3) years, and various recalls later (e.g., peanut butter, spinach, and eggs), substantial change (response from leadership) has yet to be approved.

The relationship between government and business should be a collaborative partnership; each partner should be held to the same standard.

© Coda Corp USA 2010.  All rights reserved.
__________________________
Authors:
Gina Guido-Redden & Corrine R. Knight
Coda Corp USA

www.CodaCorpUSA.com

References:
1 http://www.gao.gov/new.items/d07785t.pdf
2 http://www.feedstuffs.com/ME2/dirmod.asp?sid=F4D1A9DFCD974EAD8CD5205E15C1CB42&nm=Breaking+News&type=news&mod=News&mid=A3D60400B4204079A76C4B1B129CB433&tier=3&nid=5CCA4DF40E5540AEA5421C0C933DAFC6
3 http://asq.org/qualitynews/qnt/execute/displaySetup?newsID=9484
4 http://www.npr.org/templates/story/story.php?storyId=129373553
5 http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/EggSafety/EggSafetyActionPlan/ucm170746.htm
6 http://www.washingtontimes.com/news/2010/aug/22/farms-involved-in-egg-recall-share-suppliers/
7 http://online.wsj.com/article/SB10001424052748703989304575504241496073512.html
8 http://www.govtrack.us/congress/bill.xpd?bill=s111-510&tab=summary
9 http://energycommerce.house.gov/documents/20100922/Stupak.Statement.09.22.2010.oi.pdf

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One Comment

  1. Posted December 10, 2010 at 5:40 pm | Permalink

    FDA has notified Wright Egg Company that they are now allowed to sell eggs to the market from two of their hen houses on one of its six farms. The company has not sold eggs to the public since August 2010, when the company’s eggs were responsible for the recall of 380 million eggs due to an outbreak of Salmonella Enteritidis (SE).

    FDA Commissioner Margaret Hamburg stated, “During the outbreak, I said that FDA would not agree to the sale of eggs to consumers from Wright County Egg until we had confidence that they could be shipped and consumed safely. After four months of intensive work by the company and oversight, testing, and inspections by FDA, I am satisfied that time has come.”
    Wright County Egg has improved the following threats to public health:

    • Contaminated egg-laying environment – The hens present during the outbreak have been removed and the houses cleaned and tested.

    • Infected pullets – Pullets present during the outbreak have been removed and were replaced with SE negative pullets that have been vaccinated for SE.

    • Rodents – A system has been put in place to control and monitor rodents on a weekly basis

    • Contaminated feed – The feed mill has been cleaned and structurally repaired. Certain components from the feed have been removed and the feed has been tested.

    Since October, FDA inspections at Wright County Egg have involved 13 investigators and over 900 working hours. The FDA has also collected and analyzed 40 feed samples, 236 environmental samples and 13,900 eggs. The FDA claims they will continue to monitor all of the hen houses.
    Austin Decoster’s companies responsible for the egg recall, Wright County Egg and Quality Egg, are still under surveillance. While Wright County Egg has made changes and outlook is now more positive, Quality Egg still needs intensive work.

    In October, Austin Decoster received a Warning Letter for Quality Egg stating that the following actions had not yet been completed and that they not in compliance because they had not yet:

    • Eliminated rodent hiding places

    • Properly sealed all hen houses

    • Properly eliminated all sources of water in manure pits

    • Taken biosecurity measures to ensure that there is no introduction or transfer of SE into or among poultry houses

    • Satisfactorily controlled rodent and pest control

    • Documented properly records in the SE Protection Plan

    In the Warning Letter, FDA reminded Quality Egg, “You should take prompt and aggressive actions to eliminate the Salmonella Enteritidis contamination and the observations described in this letter. Failure to take prompt corrective action may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure and/or injunction.”

    The collaborative partnership between the FDA and Wright Egg Company has yielded positive results. The quality of their product is increasing. The relationship between government and business should be a collaborative partnership; each partner should be held to the same standard. Hopefully Quality Egg will also soon be in compliance and work with the FDA to ensure a high standard of quality for their products.

    © Coda Corp USA 2010. All rights reserved.
    __________________________
    Author:
    Corrine R. Knight
    http://www.CodaCorpUSA.com

    References:
    1 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm235179.htm
    2 http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm229805.htm

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