Gao

  • Posted: March 10th, 2012 - 12:50am by Doug Powell

    A new report concludes the federal government should provide more specific public guidance on the license approval requirements of vaccines that could reduce the incidence of E. coli O157:H7 and friends in cattle.

    Because right now, it’s bureaucratic, and no one can offer a clear explanation.

    The U.S Government Accountability Project in report GAO-12-257 (for sticklers) also concluded the Secretary of Agriculture should explore practices employed by other countries that are not currently used in the U.S. for reducing shiga-toxin producing E. coli (STEC) in cattle and consider whether the identified practices can inform U.S. efforts.

    From the report:

    U.S. Department of Agriculture (USDA) and university researchers identified several treatments administered before cattle are slaughtered, or preslaughter interventions, that could reduce Shiga toxin-producing Escherichia coli (STEC) in cattle. Such preslaughter interventions include bacteriophages (viruses that infect and kill bacteria), probiotics (live bacteria that can benefit the digestive system), vaccines (biological preparations that alter the immune system), and sodium chlorate (chemical that kills the STEC O157:H7 strain). However, few manufacturers have submitted applications for preslaughter intervention products to target STEC according to officials from USDA and the Food and Drug Administration. One exception is for vaccines to reduce STEC O157:H7.

    For preslaughter interventions, USDA exercises responsibilities for licensing and regulating STEC vaccines. However, USDA’s approval requirements for these vaccines are unclear, according to some industry representatives. Specifically, USDA’s general guidance does not address some of the unique challenges faced by manufacturers of animal health products seeking STEC vaccine approval. For example, the guidance does not explain that, if studies conducted in the laboratory are insufficient to demonstrate efficacy, the manufacturer would also need to demonstrate that the vaccine is effective in a field setting such as a feedlot. In contrast, the Canadian Centre for Veterinary Biologics provides more specific guidance about when it requires the use of laboratory or field studies to demonstrate efficacy for vaccine license applications. Without guidance that gives manufacturers clear and more specific information they need to submit for an acceptable application, the approval process for STEC vaccines could face potential delays.

    In addition to STEC O157:H7, which it stated in 1994 was an adulterant—a substance that renders food injurious to human health—in September 2011, USDA determined that six other STEC strains were adulterants in raw ground beef and beef trim (meat left after steaks and roasts are cut from beef). USDA has tests for these six strains and plans to use them in slaughter plants starting in June 2012. However, it may be difficult and time-consuming to confirm positive test results because certain test components are either not commercially available for all strains or do not always provide clear results. USDA is working to improve the tests and to find a commercial supplier for one key test component. Also, a few companies voluntarily test for these strains.

    Some foreign governments have practices that could be relevant to U.S. efforts to reduce STEC in cattle such as the following:

    The European Parliament and the Council of the European Union require certain measures, such as verification of cleanliness by an inspector, to ensure that the cattle going to slaughter are clean. In contrast, USDA assesses the health of cattle but does not inspect for cleanliness.
    At least 12 European Union member countries collected and reported data on STEC in live cattle in 2009. USDA has conducted STEC testing in live cattle, but has not tested since 1999.
    When a person becomes ill from E. coli in Sweden, government officials try to determine the specific farm that sold the contaminated cattle so that other carcasses from the farm can be tested for STEC. USDA does not trace the STEC source back to the farm.

    The complete report is available at http://www.gao.gov/products/GAO-12-257.

    Your rating: None (1 vote)
    Bookmark and Share
  • Posted: September 26th, 2008 - 3:12pm by Doug Powell

    The U.S. Government Accountability Office reported today that the Food and Drug Administration's efforts to combat foodborne illness are hampered by infrequent inspections, not enough staff and the failure to implement a program devoted to the safety of fresh produce.

    The report said that inspections at produce-processing facilities are rare and that when problems are discovered, the FDA relies on the industry to correct them without oversight or follow-up. …

    The report also cited previously unpublished FDA data showing that 14 people died and 10,253 were sickened in 96 outbreaks associated with fresh produce from 1996 through 2006. This summer, salmonella sickened at least 1,440 people in 43 states and Washington, D.C.

    But the report found that only 3% of the FDA's food safety budget goes toward efforts to protect fresh produce.


     

    Your rating: None
    Bookmark and Share
  • Posted: July 16th, 2008 - 6:49am by Doug Powell

    When it comes to the safety of the food supply, I generally ignore the chatter from Washington. If a proposal does emerge, such as the creation of a single food inspection agency, I ask, Will it actually make food safer? Will fewer people get sick?

    Much is being made this morning about a new report from the U.S. General Accounting Office, and how the U.S. is lagging behind other countries – countries that have single food inspection systems. The Chicago Tribune says, On food safety, U.S. not No. 1, while the L.A. Times  offers an editorial, U.S. lags on food regulation.

    So I spent the end of another stellar day in Melbourne, and the beginning of a new day back home, by reading the report and comparing it to some of the Washington chatter.

    Senator Dick Durbin (D-IL) said,

    "Today's GAO report shows that America ranked eighth out of eight countries -- dead last -- in terms of national food safety systems.”

    There was no such ranking in the report. There was no ranking at all in the report.

    Congresswoman Rosa L. DeLauro (CT-3) said,

    “This GAO report highlights how effectively a single food safety agency could protect our food supply. … By focusing on the entire food supply chain, placing primary responsibility for food safety on producers, and ensuring that food imports meet equivalent safety standards. …”

    The U.S. system already does that. And the report says nothing about how a single food inspection agency could better accomplish such tasks.

    The Center for Science in the Public Interest says,

    “The GAO report also shows that creating a unified food safety program is technologically and economically feasible, and most important, effective in helping to reduce foodborne illness.”


    There were no measures of effectiveness for any of the single food inspection agencies, other than whether public opinion or confidence in the shiny, happy new agencies increased over time based on self-reported surveys. A few advertisements could have accomplished that.

    There was certainly no mention of any agency reducing the incidence of foodborne illness. The seven countries studied – Canada, UK, New Zealand, Ireland, Denmark, Germany and The Netherlands – said they reorganized their food inspection agencies to improve effectiveness and efficiency; not one said to improve public health and have fewer sick people.

    The GAO report -- Selected Countries’ Systems Can Offer Insights into Ensuring Import Safety and Responding to Foodborne Illness – did say:

    “The burden for food safety in most of the selected countries lies primarily with food producers, rather than with inspectors, although inspectors play an active role in overseeing compliance. This principle applies to both domestic and imported products.”

    That’s good.

    “None of the selected countries had comprehensively evaluated its reorganized food safety system … Most of the selected countries use proxy measures, such as public opinion surveys, to assess their effectiveness. Public opinion in several countries has improved in recent years.”

    That’s bad.

    In Canada, “At the consumer end of the spectrum, the food safety agency educates Canadians about safe food-handling practices and various food safety risks through its Web site, food safety fact sheets, and the Canadian Partnership for Consumer Food Safety Education, a group of industry, consumer, and government organizations that jointly develop and implement a national program to educate consumers on how to safely handle food.”

    That’s awful.

    To summarize: no rankings, no measures of effectiveness, and not much fact-checking.

    Should there be a single food inspection agency in the U.S.? Maybe. But will it enhance the safety of the food supply? Will it mean fewer sick people?



    Your rating: None
    Bookmark and Share
  • Posted: January 29th, 2008 - 1:18pm by Doug Powell

    Christopher Doering of Reuters reports that the U.S. Government Accountability Office said in a report today that the U.S. Food and Drug Administration's failure to discuss clearly its strategy and the money needed to better protect the country's food supply could make it harder for a plan to succeed.

    The GAO report also noted that FDA must better leverage its existing resources "as staffing levels and funding have not kept pace with the agency's growing responsibilities" to oversee the food supply.

    GAO noted that even as food imports surge, FDA inspectors of foreign food firms has dropped from 211 in fiscal year 2001 to fewer than 100 in 2007. About 15 percent of the overall U.S. food supply is imported.

    Rep. John Dingell, chairman of the House Energy and Commerce committee, said,

    "Our constituents are growing weary of these events. They are losing confidence in this agency's ability to protect them from the products they use daily."
    Your rating: None
    Bookmark and Share