{"id":7317,"date":"2012-04-30T00:01:55","date_gmt":"2012-04-30T04:01:55","guid":{"rendered":"https:\/\/www.beyondpesticides.org\/dailynewsblog\/?p=7317"},"modified":"2012-04-29T22:36:29","modified_gmt":"2012-04-30T02:36:29","slug":"citing-lack-of-efficacy-epa-orders-hospital-disinfectant-removed-from-market","status":"publish","type":"post","link":"https:\/\/beyondpesticides.org\/dailynewsblog\/2012\/04\/citing-lack-of-efficacy-epa-orders-hospital-disinfectant-removed-from-market\/","title":{"rendered":"Citing Lack of Efficacy, EPA Orders Hospital Disinfectant Removed from Market"},"content":{"rendered":"<p><font size=\"2\">(<em>Beyond Pesticides<\/em>, April 30, 2012)<img loading=\"lazy\" decoding=\"async\" alt=\"\" src=\"http:\/\/textbookofbacteriology.net\/MTBCDC.jpg\" title=\"http:\/\/textbookofbacteriology.net\/MTBCDC.jpg\" class=\"alignright\" align=\"right\" width=\"300\" height=\"202\" \/> The U.S. Environmental Protection Agency (EPA) has ordered the manufacturer of an antimicrobial disinfectant intended for use in hospitals to remove the product from sale. Citing a violation of the <em>Federal Insecticide, Fungicide, Rodenticide Act <\/em>(FIFRA), EPA issued a <a href=\"https:\/\/www.beyondpesticides.org\/documents\/Zep%20SSURO.pdf\">Stop Sale, Use, or Removal Order<\/a> (SSURO) on April 16 to Zep, Inc. for its product \u201cZEP Formula 165.\u201d EPA determined through its Antimicrobial Testing Program (ATP) that this antimicrobial disinfectant was, contrary to label claims, ineffective against the debilitating and potentially fatal human pathogen <em>Mycobacterium Tuberculosis<\/em> (pictured right).<\/p>\n<p>EPA identified multiple FIFRA labeling violations after analyzing a sample of the product, which it collected on May 26, 2011.  FIFRA requires a pesticide labeled as an antimicrobial pesticide to \u201cdisinfect, sanitize, reduce or mitigate growth or development of microbiological organisms.&#8221; When laboratory analysis established that \u201cZEP Formula 165\u201d used in accordance with the label instructions was not effective against <em>Mycobacterium Tuberculosis<\/em>, the false label claim constituted a FIFRA violation. EPA cited the manufacturer for a second violation after determining that the sample it collected contained an amount of the active ingredient Para-tertiary-amyl phenyl that exceeded the upper certified limit that was established for that ingredient in the registration for that specific pesticide formulation.<\/p>\n<p>The SSURO prohibits all further sale of \u201cZEP Formula 165\u201d under the manufacturer\u2019s control or custody. The manufacturer is also required to notify EPA of the location and amount of product that it distributed during the past year. Furthermore, EPA recommended that the manufacturer take immediate steps to remove the pesticide from market by initiating a voluntary recall of all product shipped within the U.S. in the last year.<\/p>\n<p>Through ATP, EPA is requires testing of antimicrobial products, including hospital disinfectants and tuberculocides, to ensure that they meet health standards and that the claims on the product labels are accurate. However, a <a href=\"http:\/\/www.epa.gov\/oig\/reports\/2011\/20101215-11-P-0029.pdf\">2011 report<\/a> from the EPA\u2019s Office of the Inspector General (OIG) found that ATP was largely inadequate for testing products to ensure safety and efficacy, and also failed to remove products that did not meet program standards. The report noted that although testing began in 1991, more than 40% of antimicrobials (or 277 of 656) on the market have yet to be tested. <a href=\"https:\/\/www.beyondpesticides.org\/dailynewsblog\/?p=4748\">OIG concluded<\/a> that, \u201cEPA does not have a strategy for informing hospitals and other likely end-users of failed test results or when enforcement actions are taken\u201d and that, \u201cEPA\u2019s implementation of the ATP has not delivered on its mission.\u201d<\/p>\n<p>A surprisingly high number of products that were eventually tested by ATP failed to meet EPA standards and were found to require regulatory action. Since 2004, an average of one-third of products tested in a year failed. However, according to the OIG report, \u201cEPA does not have a strategy for informing hospitals and other likely end-users of failed test results or when enforcement actions are taken.\u201d It simply relies on posting a notice to the ATP website. This means that ineffective products that can potentially be of risk to public health often remain in use by hospitals and health professionals.<\/p>\n<p>The OIG report is especially of concern because some antimicrobials, such as <a href=\"https:\/\/www.beyondpesticides.org\/antibacterial\/triclosan.htm\">triclosan<\/a>, are known to cause dangerous public health and environmental hazards. Triclosan is one of the most prevalent antibacterial compounds found in products ranging from soaps and toothpastes to fabrics and toys. Studies have increasingly linked triclosan (and its chemical cousin triclocarban) to a range of adverse health and environmental effects, from skin irritation, allergy susceptibility, bacterial, endocrine disruption, and compounded antibiotic resistant, tainted water, and dioxin contamination to destruction of fragile aquatic ecosystems.<\/p>\n<p><em>Source: <a href=\"http:\/\/yosemite.epa.gov\/opa\/admpress.nsf\/0\/1E674FDCCBF8DCFC852579E60050663D\">U.S. Environmental Protection Agency<\/a><\/p>\n<p><em>Image of <em>Mycobacterium Tuberculosis <\/em>courtesy Centers for Disease Control and Prevention<\/em><\/p>\n<p>All unattributed positions and opinions in this piece are those of Beyond Pesticides.<\/em><br \/>\n<\/font><\/p>\n","protected":false},"excerpt":{"rendered":"<p>(Beyond Pesticides, April 30, 2012) The U.S. Environmental Protection Agency (EPA) has ordered the manufacturer of an antimicrobial disinfectant intended for use in hospitals to remove the product from sale. Citing a violation of the Federal Insecticide, Fungicide, Rodenticide Act (FIFRA), EPA issued a Stop Sale, Use, or Removal Order (SSURO) on April 16 to Zep, Inc. for its product \u201cZEP Formula 165.\u201d EPA determined through its Antimicrobial Testing Program (ATP) that this antimicrobial disinfectant was, contrary to label claims, ineffective against the debilitating and potentially fatal human pathogen Mycobacterium Tuberculosis (pictured right). EPA identified multiple FIFRA labeling violations after analyzing a sample of the product, which it collected on May 26, 2011. FIFRA requires a pesticide labeled as an antimicrobial pesticide to \u201cdisinfect, sanitize, reduce or mitigate growth or development of microbiological organisms.&#8221; When laboratory analysis established that \u201cZEP Formula 165\u201d used in accordance with the label instructions was not effective against Mycobacterium Tuberculosis, the false label claim constituted a FIFRA violation. EPA cited the manufacturer for a second violation after determining that the sample it collected contained an amount of the active ingredient Para-tertiary-amyl phenyl that exceeded the upper certified limit that was established for that ingredient in [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[155],"tags":[],"class_list":["post-7317","post","type-post","status-publish","format-standard","hentry","category-antibacterial"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.3 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Citing Lack of Efficacy, EPA Orders Hospital Disinfectant Removed from Market - Beyond Pesticides Daily News Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/beyondpesticides.org\/dailynewsblog\/2012\/04\/citing-lack-of-efficacy-epa-orders-hospital-disinfectant-removed-from-market\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Citing Lack of Efficacy, EPA Orders Hospital Disinfectant Removed from Market - Beyond Pesticides Daily News Blog\" \/>\n<meta property=\"og:description\" content=\"(Beyond Pesticides, April 30, 2012) The U.S. Environmental Protection Agency (EPA) has ordered the manufacturer of an antimicrobial disinfectant intended for use in hospitals to remove the product from sale. Citing a violation of the Federal Insecticide, Fungicide, Rodenticide Act (FIFRA), EPA issued a Stop Sale, Use, or Removal Order (SSURO) on April 16 to Zep, Inc. for its product \u201cZEP Formula 165.\u201d EPA determined through its Antimicrobial Testing Program (ATP) that this antimicrobial disinfectant was, contrary to label claims, ineffective against the debilitating and potentially fatal human pathogen Mycobacterium Tuberculosis (pictured right). EPA identified multiple FIFRA labeling violations after analyzing a sample of the product, which it collected on May 26, 2011. FIFRA requires a pesticide labeled as an antimicrobial pesticide to \u201cdisinfect, sanitize, reduce or mitigate growth or development of microbiological organisms.&#8221; When laboratory analysis established that \u201cZEP Formula 165\u201d used in accordance with the label instructions was not effective against Mycobacterium Tuberculosis, the false label claim constituted a FIFRA violation. EPA cited the manufacturer for a second violation after determining that the sample it collected contained an amount of the active ingredient Para-tertiary-amyl phenyl that exceeded the upper certified limit that was established for that ingredient in [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/beyondpesticides.org\/dailynewsblog\/2012\/04\/citing-lack-of-efficacy-epa-orders-hospital-disinfectant-removed-from-market\/\" \/>\n<meta property=\"og:site_name\" content=\"Beyond Pesticides Daily News Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/beyondpesticides\" \/>\n<meta property=\"article:author\" content=\"https:\/\/www.facebook.com\/beyondpesticides\/\" \/>\n<meta property=\"article:published_time\" content=\"2012-04-30T04:01:55+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/textbookofbacteriology.net\/MTBCDC.jpg\" \/>\n<meta name=\"author\" content=\"Beyond Pesticides\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ByondPesticides\" \/>\n<meta name=\"twitter:site\" content=\"@ByondPesticides\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Beyond Pesticides\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/beyondpesticides.org\/dailynewsblog\/2012\/04\/citing-lack-of-efficacy-epa-orders-hospital-disinfectant-removed-from-market\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/beyondpesticides.org\/dailynewsblog\/2012\/04\/citing-lack-of-efficacy-epa-orders-hospital-disinfectant-removed-from-market\/\"},\"author\":{\"name\":\"Beyond Pesticides\",\"@id\":\"https:\/\/beyondpesticides.org\/dailynewsblog\/#\/schema\/person\/1b5c0a0981b549cc5b628770073031f4\"},\"headline\":\"Citing Lack of Efficacy, EPA Orders Hospital Disinfectant Removed from Market\",\"datePublished\":\"2012-04-30T04:01:55+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/beyondpesticides.org\/dailynewsblog\/2012\/04\/citing-lack-of-efficacy-epa-orders-hospital-disinfectant-removed-from-market\/\"},\"wordCount\":629,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/beyondpesticides.org\/dailynewsblog\/#organization\"},\"image\":{\"@id\":\"https:\/\/beyondpesticides.org\/dailynewsblog\/2012\/04\/citing-lack-of-efficacy-epa-orders-hospital-disinfectant-removed-from-market\/#primaryimage\"},\"thumbnailUrl\":\"http:\/\/textbookofbacteriology.net\/MTBCDC.jpg\",\"articleSection\":[\"Antibacterial\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/beyondpesticides.org\/dailynewsblog\/2012\/04\/citing-lack-of-efficacy-epa-orders-hospital-disinfectant-removed-from-market\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/beyondpesticides.org\/dailynewsblog\/2012\/04\/citing-lack-of-efficacy-epa-orders-hospital-disinfectant-removed-from-market\/\",\"url\":\"https:\/\/beyondpesticides.org\/dailynewsblog\/2012\/04\/citing-lack-of-efficacy-epa-orders-hospital-disinfectant-removed-from-market\/\",\"name\":\"Citing Lack of Efficacy, EPA Orders Hospital Disinfectant Removed from Market - 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By forging ties with governments, nonprofits, and people who rely on these natural resources, we reduce the need for unnecessary pesticide use and protect public health and the environment. Beyond Pesticides provides hands-on services to the public and supports local action by: identifying and interpreting hazards; and, designing safe pest management programs. With the information provided by Beyond Pesticides, people may not only be able to make informed choices and adopt practices that protect themselves and their families from unnecessary exposure to pesticides, but they will be able to effect changes on community-wide pest management decisions and policies that govern pesticide use, such as pesticide uses in parks, schools, for community insect control and along roadsides. 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Citing a violation of the Federal Insecticide, Fungicide, Rodenticide Act (FIFRA), EPA issued a Stop Sale, Use, or Removal Order (SSURO) on April 16 to Zep, Inc. for its product \u201cZEP Formula 165.\u201d EPA determined through its Antimicrobial Testing Program (ATP) that this antimicrobial disinfectant was, contrary to label claims, ineffective against the debilitating and potentially fatal human pathogen Mycobacterium Tuberculosis (pictured right). EPA identified multiple FIFRA labeling violations after analyzing a sample of the product, which it collected on May 26, 2011. FIFRA requires a pesticide labeled as an antimicrobial pesticide to \u201cdisinfect, sanitize, reduce or mitigate growth or development of microbiological organisms.&#8221; When laboratory analysis established that \u201cZEP Formula 165\u201d used in accordance with the label instructions was not effective against Mycobacterium Tuberculosis, the false label claim constituted a FIFRA violation. 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