Poison cantaloupes, courtesy U.S. FDA

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    Poison cantaloupes, courtesy U.S. FDA

    Writing in the Denver Post of January 11, Michael Booth calls attention to lack of FDA food regulations as a significant element in a September, 2011, outbreak of Listeria spread through cantaloupes, poisoning at least 146 people and killing 31 of them. FDA had issued only "guidance," which was ignored. [ Report on Listeria outbreak blames Jensen Farms and third-party auditors, at http://www.denverpost.com/news/ci_19716704 ]

    During the Reagan administration, FDA sleazebags began frequently publishing so-called "guidance" documents instead of regulations. The advantage of a "guidance" to regulated industries was that it was a mere option, not a requirement. The advantage to FDA staff was much less work, no public notice and easy evasion of their responsibilities. In the event of problems, FDA staff could always say, "We warned you." FDA was then led by Dr. Arthur Hayes, Jr., whose conflicts of interest were later exposed, leading to his abrupt resignation.

    As with many topics involving public safety, current FDA sleazebags actually wrote only a "draft guidance" on processing melons. [ Guide to minimize microbial food safety hazards of melons; Draft Guidance; Contains Nonbinding Recommendations, U.S. Food and Drug Administration, July 31, 2009, at http://www.food-label-compliance.com/Sites/5/Downloads/USFDA-Draft-Guidance-MELONS-issued-073109-complete-text.pdf ]

    Like many agricultural processors, Jensen Farms, producer of the poison cantaloupes, employed a totally unregulated "third-party auditor," Primus Labs, to check on processing safety. Primus Labs, in turn, said while it looks for violations of FDA regulations it otherwise "does not have the expertise to determine which practices should be pushed by industry." As far as Primus Labs and Jensen Farms were concerned, an FDA "draft guidance" on melons meant what it said: "Contains Nonbinding Recommendations; Draft--Not for implementation." [ Dan Flynn, Congressional probe finds many to blame for Listeria cantaloupe outbreak, Food Safety News, January 11, 2012, at http://www.foodsafetynews.com/2012/01/congress-gets-report-on-listeria-investigation/ ]

    It is common for FDA "draft guidance" documents to remain on file for years, never even made into "guidance" documents, and for "guidance" documents to persist for decades, never made into regulations. In this instance, current FDA sleazebags have tried to shut the barn door and cover their rumps with yet another such document. [ Guidance for Industry: Letter to firms that grow, harvest, sort, pack, process or ship fresh cantaloupe; Contains Nonbinding Recommendations; U.S. Food and Drug Administration, November, 2011, at http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/UCM278474.pdf ]

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    FDA uses "guidance" to evade responsibility

    U.S. FDA has had responsibility to prevent contaminated food from reaching the public since the Food, Drug and Cosmetic Act of 1938. In Section 402 of the 1938 act, "A food shall be deemed to be adulterated...[i]f it bears or contains any poisonous or deleterious substance which may render it injurious to health." Likewise, FDA has had powers to issue food processing regulations and inspect food processors involved in interstate commerce since the 1938 act. [PL75-717, 52 Stat 1040]

    Listeria monocytogenes is not some newly-discovered organism. It was identified in 1921, and its role in food contamination was shown in 1924. Several Listeria epidemics spread by food contamination have occurred in North America and Europe during the past 30 years, with high fatality rates despite antibiotic treatment. [ Jose A. Vazquez-Boland, et al., Listeria pathogenesis and molecular virulence determinants, Clinical Microbiology Reviews 14(3):584-640, 2001, at http://cmr.asm.org/content/14/3/584.full ]

    The FDA began issuing "guidance" in 1949 with publication of the document, Procedures for the Appraisal of the Toxicity of Chemicals in Food. Until the Reagan administration began to abuse it in the 1980s, FDA "guidance" played a useful role in informing regulated industries and the public about developing issues and potentially effective ways to cope with them, when there were not yet referenceable studies of sufficient scope or power to inform regulations. [ Significant dates in U.S. food and drug law history, U.S. Food and Drug Administration, 2011, at http://www.fda.gov/aboutfda/whatwedo/history/milestones/ucm128305.htm ]

    A federal case decided "guidance" is not enforceable. In the 1990s, EPA had begun to imitate the slippery FDA practice of issuing "guidance" instead of regulation. One such EPA "guidance" involved more frequent monitoring of power-plant emissions than regulations required. It was challenged and vacated. The DC Circuit Court, whose rulings are precedents binding on national activities of FDA, held that the informal process of issuing a "guidance" is insufficient to modify or comprise a regulation. A federal agency must comply "with the rulemaking procedures required by 42 USC 7607(d)." [ Appalachian Power v. Environmental Protection Agency, DC Circuit No. 98-1512, 208 F.3d 1015 at 1029, April 14, 2000, available at http://caselaw.findlaw.com/us-dc-circuit/1074158.html ]

    Reacting to the proliferation of "guidance" documents, during the Walker Bush administration OMB tried to make procedures more orderly and transparent, but its internal regulation of agencies did not meet the standard of Appalachian Power v. EPA (2000) and applies only to "significant guidance" that, among other factors, has "an annual effect on the economy of $100 million or more." [ Final bulletin for agency good guidance practices, U.S. Office of Management and Budget, 72 FR 3432-3440, January 25, 2007, available at http://www.whitehouse.gov/sites/default/files/omb/fedreg/2007/012507_good_guidance.pdf ]

    When FDA fobs off issuing regulations in favor of writing "guidance" and when it leaves inspection of food processing to unlicensed, unregulated, unsupervised "third-party auditors," it forfeits public trust.

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    Poisoned behaviors, poisoned food

    The FDA was indeed set up during Republican administrations but probably not in ways the last reader, writing like a child who lacks knowledge, meant to suggest. Its predecessor, the Bureau of Chemistry in the Department of Agriculture, was created during the Lincoln administration. The Food, Drug and Insecticide Administration, as first known, was established by executive reorganization during the Coolidge administration, still within Agriculture, and was renamed the Food and Drug Administration during the Hoover administration.

    Attempts to identify changes with particular administrations are usually vapor. Documented subversion of FDA during the Reagan administration is one of the few good counterexamples. [ for samples of gross corruption drawn from the early era of the AIDS crisis, see Jim Eigo, et al., FDA Action Handbook, ACT UP Coalition, 1988, at http://www.actupny.org/documents/FDAhandbook1.html ]

    A century and a half after its origins, FDA has become a major feature of the permanent government. More than 99 percent of its personnel are career employees. It responds only slowly to changes in political appointments. A change that the Reagan administration promoted, evading responsibility for regulations by instead issuing "guidances," had its start more than 30 years earlier, as explained, and it played into longstanding bureaucratic preferences to avoid litigation and silo the work.

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    Re: Poison cantaloupes, courtesy U.S. FDA

    Thats right Appdev. Abuse posters that do not agree with you. You post a lot of opinionated crap, with details you do not read critically so people who disagree are children? I NEVER told my children that their ideas are wrong, I just wanted them to get more facts. Just like I encourage You to get more facts. Cause you need to know how to ask questions when doing research. And your questions need work. Career employees have made many significant contributions due to their experience in the feild. Or should we only hire new people to run complex engineering strutures. Only fresh new people should run the big corporations. Only the newest buisness grads for APPLE and GE. That would work. NOT.