From jhollar at pwaste.com Mon Dec 1 12:23:04 2014 From: jhollar at pwaste.com (Jeff Hollar) Date: Mon Dec 1 12:23:16 2014 Subject: [Pharmwaste] YouTube DEA Webinar Message-ID: <001701d00d8b$782796a0$6876c3e0$@pwaste.com> Check out this DEA webinar from November 6th on YouTube. DEA summarizes some of the new regulations as they pertain to community agencies. They also provide a segment on Alameda County. Webinar for Community Agencies: The DEA's Final Rule on Disposal of Controlled Substances https://www.youtube.com/watch?v=xzJOJnhgZZ8 Jeff Hollar President PharmWaste Technologies, Inc. 4164 NW Urbandale Dr., Ste A Urbandale, IA 50322 515-276-5302 (general) 515-331-7310 (direct) 515-360-9785 (cell) www.pwaste.com -------------- next part -------------- An HTML attachment was scrubbed... URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141201/bc26a2b8/attachment.htm From Burke.Lucy at CalRecycle.ca.gov Thu Dec 4 12:41:59 2014 From: Burke.Lucy at CalRecycle.ca.gov (Lucy, Burke@CalRecycle) Date: Thu Dec 4 12:48:25 2014 Subject: [Pharmwaste] Pharmaceutical Hazardous Waste Regulations Bring Compliance Challenges Message-ID: Happy Holidays! This article touches on some state-level regulation of pharmaceutical waste from consumers... Pharmaceutical Hazardous Waste Regulations Bring Compliance Challenges November 20, 2014 http://www.environmentalleader.com/2014/11/20/pharmaceutical-hazardous-waste-regulations-bring-compliance-challenges/ Complying with the complex array of hazardous waste handling and disposal requirements under the Resource Conservation and Recovery Act ("RCRA") and its state analogues is a substantial undertaking for retail pharmacies and other "healthcare facilities." Increased federal and state enforcement against these facilities regarding, among other things, pharmaceutical waste disposal practices has prompted discussion between regulatory agencies and the regulated community about the appropriateness of applying these hazardous waste requirements to the healthcare and retail contexts. Since 2007, the EPA has issued several guidance documents clarifying various regulatory issues related to the management and disposal of pharmaceuticals that are considered hazardous waste when discarded. Alongside these guidance documents, the EPA continues the formal rule-making process to more fundamentally reshape the regulatory regime for such waste pharmaceuticals when handled and/or disposed of by retail pharmacies, other healthcare facilities, and reverse distributors. The EPA continues to divulge few details about the pending proposed rule, but it has signaled that the rule will address three broad problem areas: reverse distribution of pharmaceuticals; compliance difficulties caused by RCRA's "manufacturing-oriented framework;" and problems caused by flushing of waste pharmaceuticals. In the meantime, however, a patchwork of pharmaceutical waste regulatory regimes exist among the states, and several states have recently undertaken additional pharmaceutical waste regulatory reform efforts, further complicating compliance efforts by the regulated community, particularly for entities with operations in multiple states. For example, Rhode Island has recently adopted changes to its rules applicable to hazardous waste generators, exempting "household hazardous waste pharmaceuticals" when such waste is collected in the course of consumer take-back programs. As Rhode Island's Department of Environmental Management has noted in summarizing the state's recent changes to rules governing hazardous waste management by generators, Rhode Island has implemented the aforementioned exemption to avoid "creating confusing jurisdictional issues between DEA controlled substance requirements and hazardous waste rules for household waste." Not every state is taking this "jurisdictional issue" into account necessarily, however. New York recently enacted legislation endorsing pharmaceutical take-back events and is prompting further legislation that would establish a prescription drug disposal program in which pharmacies accept and dispose of unused drugs prescribed to residents of the state. Illinois and Pennsylvania both have pending legislation pertaining to pharmaceutical take-back events. Even though it is clear that legislated take-back events are on the rise, the legislation itself varies and seemingly further complicates the management of pharmaceutical waste. For example, while Illinois' pending legislation does not provide for compulsory take-back events, it seemingly fails at the same time to provide clear guidance to pharmacies should they decide to provide a receptacle for pharmaceutical take-backs. Pennsylvania's pending legislation, on the other hand, requires retailers of pharmaceutical drugs (which includes over-the counter products) to have in place a system for the acceptance and collection of such drugs for proper disposal. And were a retailer to not comply with Pennsylvania's pending legislation, that retailer "may not make a retail sale." Thus, while retail pharmacies operating in multiple states should anticipate state-mandated and/or regulated pharmaceutical take-back programs, states are not implementing one-size-fits-all systems for these programs that could have potentially draconian impacts should compliance become a problem. Indeed, already in place in several states are regulations covering substances in addition to those regulated by RCRA, thereby subjecting additional pharmaceuticals to heightened handling and storage requirements. Connecticut, for example, regulates many non-RCRA pharmaceutical wastes as "Connecticut Regulated Waste" (even though the state's Department of Energy and Environmental Protection has concurrently established a stakeholder group to develop regulations to manage pharmaceutical waste in a different manner - as "universal waste"). "Connecticut Regulated Waste" is subject to the same storage requirements as RCRA hazardous waste and must be transported and disposed by state-permitted vendors. Michigan, in contrast, regulates pharmaceutical waste as "universal waste," which designation entails handling and disposal requirements greater than those applicable to non-hazardous solid waste but lesser than those applicable to RCRA hazardous waste. Moreover, Michigan distinguishes between various types of pharmaceutical waste (such as "bulk hazardous pharmaceutical waste" and "non-hazardous pharmaceutical waste"), each of which carries different requirements and has resulted in state regulation of more than 150 wastes in addition to RCRA-wastes. Florida, too, has a Universal Pharmaceutical Waste Rule, but the rule itself is not as straightforward as it might seem, since numerous pharmaceuticals have special exemptions and handling requirements within the state. Of course, these state-specific requirements become even more complicated when pharmaceutical waste is transported through or managed in multiple states, compounding the attention pharmacy retailers and health care facilities must pay to nuanced state regulations. EPA has expressed that one of the goals of the current pharmaceutical waste rule-making is to promote consistency of pharmaceutical waste handling and disposal requirements. As is evident to regulators and the regulated community alike, this consistency is sorely needed. The pending proposed rule is expected to be published in December 2014 and the final rule could become effective around mid-2016. In the meantime, retail pharmacies, other healthcare facilities, and reverse distributors will have to continue working through the constantly evolving regulatory patchwork. Ted Wolff is a partner in Manatt, Phelps & Phillips' New York office and focuses his environmental practice on litigation and transactional work. He regularly counsels clients on compliance with environmental laws, including those that regulate the handling, storage, treatment and disposal of hazardous substances and waste. Mr. Wolff can be reached at (212) 790-4575 or twolff@manatt.com. Matthew Dombroski is an associate with Manatt, Phelps & Phillips in New York and regularly counsels clients on environmental matters relating to corporate and regulatory compliance. Mr. Dombroski can be reached at (212) 790-4556 or mdombroski@manatt.com. Judd Grutman is an associate in Manatt, Phelps & Phillips' Litigation Division and is based in the firm's Los Angeles and New York offices. He can be reached at 310.312.4282 or jgrutman@manatt.com. This column is part of a series of articles by law firm Manatt, Phelps & Phillips, LLP's Energy, Environment & Natural Resources practice. Earlier columns in the fourth edition of this series discussed Measures to Address Drought Conditions, Guidance Pending from NEPA on Climate Change, California's Proposed Overhaul of Standards for Transportation-related Environmental Impact Analysis, CPUC's Energy Storage Rulemaking, EPA's Proposed Rule for Reducing Carbon Emissions from Power Plants, Nanomaterial Safety Research Plans, the Obama Administration's Plans to Reduce Methane Emissions, US Ban on Oil Exports and Environmental Risks in Buying Contaminated Properties. Mr. Burke Lucy Environmental Scientist Department of Resources Recycling and Recovery (CalRecycle) 1001 I Street, PO Box 4025 Sacramento, CA 95812 Burke.Lucy@CalRecycle.ca.gov 916.341.6592 [California Department of Resources Recycling and Recovery (CalRecycle)] Connect with us! [Visit CalRecycle on FaceBook] [Follow CalRecycle on Twitter] [Subscribe to CalRecycle Feeds] [Find CalRecycle videos on YouTube] [CalRecycle Mobile App] -------------- next part -------------- An HTML attachment was scrubbed... URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141204/1ab0d45e/attachment.htm -------------- next part -------------- A non-text attachment was scrubbed... Name: image001.jpg Type: image/jpeg Size: 2661 bytes Desc: image001.jpg Url : http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141204/1ab0d45e/image001.jpg -------------- next part -------------- A non-text attachment was scrubbed... Name: image002.png Type: image/png Size: 2143 bytes Desc: image002.png Url : http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141204/1ab0d45e/image002.png -------------- next part -------------- A non-text attachment was scrubbed... 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Name: image006.png Type: image/png Size: 3260 bytes Desc: image006.png Url : http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141204/1ab0d45e/image006.png From Heidi at calpsc.org Mon Dec 8 20:03:38 2014 From: Heidi at calpsc.org (Heidi Sanborn) Date: Mon Dec 8 20:04:09 2014 Subject: [Pharmwaste] FW: FYI...Groups merge to form big California biotech lobbying group In-Reply-To: <5485D1EF0200005D00011952@isdgrpwinet2vsp01.co.sanmateo.ca.us> References: <5485D1EF0200005D00011952@isdgrpwinet2vsp01.co.sanmateo.ca.us> Message-ID: <24D2A3DBD4377240A1B613A8B5293DBD1F400780@MBX029-E1-VA-8.EXCH029.DOMAIN.LOCAL> Groups merge to form big California biotech lobbying group By Stephanie M. Lee on December 8, 2014 11:31 AM The Bay Area biotech industry?s advocacy organization is merging with another group to become a newly created organization that will represent all of California?s biomedical industry. The new group, the California Biomedical Innovation Alliance, will be made up of the Bay Area Bioscience Association, or BayBio, and the California Healthcare Institute, a San Diego think tank focused on the state?s biopharmaceutical community, the groups said Monday. The CEO will be Sara Radcliffe, who brings a familiarity with federal health and drug regulations as the current executive vice president for health at the Biotechnology Industry Organization, the biotech industry?s national lobbying and policy group. In another sign that California?s biotech companies want to increase their influence in Washington, the new group will have an office in the nation?s capital in addition to La Jolla, South San Francisco and Sacramento. The Alliance will be chaired by Rick Winningham, chairman and CEO of Theravance BioPharma and chairman of the California Healthcare Institute. Hal Van Wart, president and CEO of CymaBay Therapeutics and chairman of BayBio, will become the initial vice chairman. The merger is expected to be completed by the end of March. ?I have worked with many CHI and BayBio staff and member organizations during my career,? Radcliffe said in a statement, ?and I am very much looking forward to leading the newly formed CBI?s efforts to fortify and expand the breadth, depth and reach of CHI and BayBio?s mission of advocacy on behalf of biomedical innovation throughout the state.? -------------- next part -------------- An HTML attachment was scrubbed... URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141209/4864c4ed/attachment.html From Laurie.Tenace at dep.state.fl.us Tue Dec 16 08:05:25 2014 From: Laurie.Tenace at dep.state.fl.us (Tenace, Laurie) Date: Tue Dec 16 08:09:03 2014 Subject: [Pharmwaste] remembering Theo Colburn Message-ID: <01a5b4b0b772416193513102dae5a15e@CY1PR09MB0555.namprd09.prod.outlook.com> Remembering the genius who got BPA out of your water bottles, and so much more http://grist.org/business-technology/remembering-the-genius-who-got-bpa-out-of-your-water-bottles-and-so-much-more/ It was the late 1970s and Theo Colborn was, like pretty much everyone else in the '70s, getting divorced. She was in her 50s and already retired from a career as a pharmacist. She'd moved to a hobby farm that was close to the Rocky Mountain Biological Station in Colorado and volunteered as a field researcher, sampling water and insects for signs that they were picking up toxics released by mining operations in the area. When she thought about what she should do next with her life, the answer that came to her was "become an expert in water sampling techniques." So Colborn went back to school. In 1985, at 58, she graduated from the University of Wisconsin-Madison with a Ph.D. in zoology and minors in epidemiology, toxicology, and water chemistry. "I wanted to get the education," she said, in a 1988 Frontline interview,"so that I could maybe undo some of the things that my generation basically foisted on society." By the time Colborn died yesterday, at the age of 87, she had immersed herself in decades of research - and inspired even more research - that sought to do just that. The many, many proposed BPA bans? Go back to the very beginning, and you'll find Colborn. The concern over dwindling sperm counts? Same thing. After she graduated, Colborn went to work in Washington, D.C., first as a Congressional Fellow and then as an analyst, researching industrial emissions and ozone for the Clean Air Act. When those projects ended, she was hired by two conservation organizations, the World Wildlife Fund and The Conservation Foundation, to put together an overview of Great Lakes water quality with another researcher, Richard Liroff. In the Frontline interview, she talked about what happened next: I was working on a book on the state of the environment of the Great Lakes. And I pulled all this literature together, lots of papers, you know: fellows working in Canada, people working in the United States, one out on Lake Superior, others over, way over on Lake Ontario had done some work, written their papers, had them published in a number of different journals. None of them knew what the other was doing. And basically, I sat in a wonderful position where I pulled all this information together. And looking at it I said, "There is something wrong here." And the easiest thing for me to do is to use - thank goodness for computers - use a spreadsheet at a computer and start producing these spreadsheets. And as I plotted those names of the animals in the column on the left-hand side, this is called the "Y" column, and then on the "X" column I plotted the effects that were seen in the animals, it began to fall out that there were serious problems and actually population declines, population crashes, actually extirpation of some populations. They disappeared in some places. What Colborn was seeing was the result of a wide variety of synthetic chemicals that had come into being in the 1950s and '60s. Even though they were present in the water at very low concentrations, they were subtly changing how the animals in that system developed - how their genes were programmed, how their cells differentiated and spread out through their bodies, and, ultimately, how they were able to survive and reproduce into the next generation. The healthy wildlife around the Great Lakes, often, were those animals that had grown up elsewhere and migrated as adults. When their offspring failed to reach adulthood, or couldn't reproduce, they were replaced by a fresh fleet of new arrivals. The lakes looked healthy, in other words, but they were a death trap. Colborn credited this breakthrough, in part, to her unconventional scientific background. I looked at it from an entirely different perspective. I looked at endocrinology differently. I began to look at toxicology. I was not trained in toxicology. I was trained in pharmacology until I went back to college to get my Ph.D. in my old age. Only then did I begin to sit in on toxicology courses. There is a reductionism in scientists, in the scientific community. I have never been a reductionist. I am always thinking about the big picture. My thesis committee for my Ph.D. will tell you that. They had trouble with me. At the time, Colborn said, scientists working on environmental issues had primarily been looking for cancer, which she described as "the big bugaboo." Cancer was a rare event: In order to emerge, it had to circumvent the body's defenses, and in a polluted community, not everyone would come down with it. What Colborn found was different: To a developing organism, even an infinitesimally small exposure could alter fetal development and the possible effects - lower IQ, organ damage, trouble reproducing - could be spread out across a community like jam on toast. The concept was so new there wasn't even a term for it. In 1991, Colborn and a team of 21 international scientists working on the issue came up with one: endocrine disruption. Unlike a lot of scientists, Colborn was not shy about becoming a public figure. She co-authored a popular science book with the dramatic title of Our Stolen Future. She founded a nonprofit called the Endocrine Disruption Exchange, which, among other things, helped fund and cheerlead more research into endocrine disruption and its causes. Colborn continued to do solid research and she also went pretty far out on quite a few limbs, blaming chemicals derived from fossil fuels for everything from Parkinsons to Alzheimers to obesity to autism spectrum disorder. "Governments must take heed immediately," she wrote, earlier this year, "or there will be too few healthy, intelligent individuals left to preserve our humanitarian society and create some semblance of world peace." (As if we don't have a pretty significant historical record showing that humans were more than eager to be complete jerks to each other long before anyone started messing with the benzene ring.) Still, her big message was incontestable - that over 60 years ago, we began to introduce all of these chemicals into the environment, and we still have no idea what most of them do to us. In raising these questions, Colburn got us closer to looking for answers. Laurie Tenace Environmental Specialist Waste Reduction Section Florida Department of Environmental Protection 2600 Blair Stone Road, MS 4555 Tallahassee, FL 32399-2400 850.245.8759 Laurie.Tenace@dep.state.fl.us -------------- next part -------------- An HTML attachment was scrubbed... URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141216/8b9fd126/attachment.html From zenllc at usfamily.net Tue Dec 16 10:07:55 2014 From: zenllc at usfamily.net (Catherine Zimmer) Date: Tue Dec 16 10:09:02 2014 Subject: [Pharmwaste] remembering Theo Colburn In-Reply-To: <01a5b4b0b772416193513102dae5a15e@CY1PR09MB0555.namprd09.prod.outlook.com> References: <01a5b4b0b772416193513102dae5a15e@CY1PR09MB0555.namprd09.prod.outlook.com> Message-ID: <003901d01942$12dccaa0$38965fe0$@usfamily.net> Hi Laurie and all, Laurie, Thanks so much for sending this. Yes, Theo was a genius-she brought together environmental contaminants and hormonal problems first noticing them in wildlife-where they persist and then linking to humans. She was instrumental in getting EPA to develop testing for endocrine disruptors, although after years and years the process is not complete. If you haven't read "Our Stolen Future", or visited the website, I encourage you to do so. The issue of pharmaceuticals in our water is but the tip of the iceberg. Very truly yours, Catherine Zimmer, MS, BSMT Zimmer Environmental Improvement, LLC St. Paul, MN Ph: 651.645.7509 zenllc@usfamily.net From: pharmwaste-bounces@lists.dep.state.fl.us [mailto:pharmwaste-bounces@lists.dep.state.fl.us] On Behalf Of Tenace, Laurie Sent: Tuesday, December 16, 2014 7:10 AM To: 'pharmwaste@lists.dep.state.fl.us' Subject: [Pharmwaste] remembering Theo Colburn Remembering the genius who got BPA out of your water bottles, and so much more http://grist.org/business-technology/remembering-the-genius-who-got-bpa-out- of-your-water-bottles-and-so-much-more/ It was the late 1970s and Theo Colborn was, like pretty much everyone else in the '70s, getting divorced. She was in her 50s and already retired from a career as a pharmacist. She'd moved to a hobby farm that was close to the Rocky Mountain Biological Station in Colorado and volunteered as a field researcher, sampling water and insects for signs that they were picking up toxics released by mining operations in the area. When she thought about what she should do next with her life, the answer that came to her was "become an expert in water sampling techniques." So Colborn went back to school. In 1985, at 58, she graduated from the University of Wisconsin-Madison with a Ph.D. in zoology and minors in epidemiology, toxicology, and water chemistry. "I wanted to get the education," she said, in a 1988 Frontline interview,"so that I could maybe undo some of the things that my generation basically foisted on society." By the time Colborn died yesterday, at the age of 87, she had immersed herself in decades of research - and inspired even more research - that sought to do just that. The many, many proposed BPA bans ? Go back to the very beginning, and you'll find Colborn. The concern over dwindling sperm counts ? Same thing. After she graduated, Colborn went to work in Washington, D.C., first as a Congressional Fellow and then as an analyst, researching industrial emissions and ozone for the Clean Air Act. When those projects ended, she was hired by two conservation organizations, the World Wildlife Fund and The Conservation Foundation, to put together an overview of Great Lakes water quality with another researcher, Richard Liroff. In the Frontline interview, she talked about what happened next: I was working on a book on the state of the environment of the Great Lakes. And I pulled all this literature together, lots of papers, you know: fellows working in Canada, people working in the United States, one out on Lake Superior, others over, way over on Lake Ontario had done some work, written their papers, had them published in a number of different journals. None of them knew what the other was doing. And basically, I sat in a wonderful position where I pulled all this information together. And looking at it I said, "There is something wrong here." And the easiest thing for me to do is to use - thank goodness for computers - use a spreadsheet at a computer and start producing these spreadsheets. And as I plotted those names of the animals in the column on the left-hand side, this is called the "Y" column, and then on the "X" column I plotted the effects that were seen in the animals, it began to fall out that there were serious problems and actually population declines, population crashes, actually extirpation of some populations. They disappeared in some places. What Colborn was seeing was the result of a wide variety of synthetic chemicals that had come into being in the 1950s and '60s. Even though they were present in the water at very low concentrations, they were subtly changing how the animals in that system developed - how their genes were programmed, how their cells differentiated and spread out through their bodies, and, ultimately, how they were able to survive and reproduce into the next generation. The healthy wildlife around the Great Lakes, often, were those animals that had grown up elsewhere and migrated as adults. When their offspring failed to reach adulthood, or couldn't reproduce, they were replaced by a fresh fleet of new arrivals. The lakes looked healthy, in other words, but they were a death trap. Colborn credited this breakthrough, in part, to her unconventional scientific background . I looked at it from an entirely different perspective. I looked at endocrinology differently. I began to look at toxicology. I was not trained in toxicology. I was trained in pharmacology until I went back to college to get my Ph.D. in my old age. Only then did I begin to sit in on toxicology courses. There is a reductionism in scientists, in the scientific community. I have never been a reductionist. I am always thinking about the big picture. My thesis committee for my Ph.D. will tell you that. They had trouble with me. At the time, Colborn said, scientists working on environmental issues had primarily been looking for cancer, which she described as "the big bugaboo." Cancer was a rare event: In order to emerge, it had to circumvent the body's defenses, and in a polluted community, not everyone would come down with it. What Colborn found was different: To a developing organism, even an infinitesimally small exposure could alter fetal development and the possible effects - lower IQ, organ damage, trouble reproducing - could be spread out across a community like jam on toast. The concept was so new there wasn't even a term for it. In 1991, Colborn and a team of 21 international scientists working on the issue came up with one: endocrine disruption. Unlike a lot of scientists, Colborn was not shy about becoming a public figure. She co-authored a popular science book with the dramatic title of Our Stolen Future. She founded a nonprofit called the Endocrine Disruption Exchange , which, among other things, helped fund and cheerlead more research into endocrine disruption and its causes. Colborn continued to do solid research and she also went pretty far out on quite a few limbs, blaming chemicals derived from fossil fuels for everything from Parkinsons to Alzheimers to obesity to autism spectrum disorder. "Governments must take heed immediately," she wrote, earlier this year, "or there will be too few healthy, intelligent individuals left to preserve our humanitarian society and create some semblance of world peace." (As if we don't have a pretty significant historical record showing that humans were more than eager to be complete jerks to each other long before anyone started messing with the benzene ring.) Still, her big message was incontestable - that over 60 years ago, we began to introduce all of these chemicals into the environment, and we still have no idea what most of them do to us. In raising these questions, Colburn got us closer to looking for answers. Laurie Tenace Environmental Specialist Waste Reduction Section Florida Department of Environmental Protection 2600 Blair Stone Road, MS 4555 Tallahassee, FL 32399-2400 850.245.8759 Laurie.Tenace@dep.state.fl.us -------------- next part -------------- An HTML attachment was scrubbed... URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141216/d00e2194/attachment.htm From GILLIAM at adeq.state.ar.us Tue Dec 16 11:10:03 2014 From: GILLIAM at adeq.state.ar.us (Gilliam, Allen) Date: Tue Dec 16 11:08:12 2014 Subject: [Pharmwaste] RE: remembering Theo Colburn In-Reply-To: <01a5b4b0b772416193513102dae5a15e@CY1PR09MB0555.namprd09.prod.outlook.com> References: <01a5b4b0b772416193513102dae5a15e@CY1PR09MB0555.namprd09.prod.outlook.com> Message-ID: Good story Laurie, thanks for sharing. Ms. Colburn must have been quite the visionary. A sad parallel to global warming. The human race is indeed ignorantly sealing the earth's fate on so many fronts in the name of the almighty dollar. Allen g From: pharmwaste-bounces@lists.dep.state.fl.us [mailto:pharmwaste-bounces@lists.dep.state.fl.us] On Behalf Of Tenace, Laurie Sent: Tuesday, December 16, 2014 7:05 AM To: 'pharmwaste@lists.dep.state.fl.us' Subject: [Pharmwaste] remembering Theo Colburn Remembering the genius who got BPA out of your water bottles, and so much more http://grist.org/business-technology/remembering-the-genius-who-got-bpa-out-of-your-water-bottles-and-so-much-more/ It was the late 1970s and Theo Colborn was, like pretty much everyone else in the '70s, getting divorced. She was in her 50s and already retired from a career as a pharmacist. She'd moved to a hobby farm that was close to the Rocky Mountain Biological Station in Colorado and volunteered as a field researcher, sampling water and insects for signs that they were picking up toxics released by mining operations in the area. When she thought about what she should do next with her life, the answer that came to her was "become an expert in water sampling techniques." So Colborn went back to school. In 1985, at 58, she graduated from the University of Wisconsin-Madison with a Ph.D. in zoology and minors in epidemiology, toxicology, and water chemistry. "I wanted to get the education," she said, in a 1988 Frontline interview,"so that I could maybe undo some of the things that my generation basically foisted on society." By the time Colborn died yesterday, at the age of 87, she had immersed herself in decades of research - and inspired even more research - that sought to do just that. The many, many proposed BPA bans? Go back to the very beginning, and you'll find Colborn. The concern over dwindling sperm counts? Same thing. After she graduated, Colborn went to work in Washington, D.C., first as a Congressional Fellow and then as an analyst, researching industrial emissions and ozone for the Clean Air Act. When those projects ended, she was hired by two conservation organizations, the World Wildlife Fund and The Conservation Foundation, to put together an overview of Great Lakes water quality with another researcher, Richard Liroff. In the Frontline interview, she talked about what happened next: I was working on a book on the state of the environment of the Great Lakes. And I pulled all this literature together, lots of papers, you know: fellows working in Canada, people working in the United States, one out on Lake Superior, others over, way over on Lake Ontario had done some work, written their papers, had them published in a number of different journals. None of them knew what the other was doing. And basically, I sat in a wonderful position where I pulled all this information together. And looking at it I said, "There is something wrong here." And the easiest thing for me to do is to use - thank goodness for computers - use a spreadsheet at a computer and start producing these spreadsheets. And as I plotted those names of the animals in the column on the left-hand side, this is called the "Y" column, and then on the "X" column I plotted the effects that were seen in the animals, it began to fall out that there were serious problems and actually population declines, population crashes, actually extirpation of some populations. They disappeared in some places. What Colborn was seeing was the result of a wide variety of synthetic chemicals that had come into being in the 1950s and '60s. Even though they were present in the water at very low concentrations, they were subtly changing how the animals in that system developed - how their genes were programmed, how their cells differentiated and spread out through their bodies, and, ultimately, how they were able to survive and reproduce into the next generation. The healthy wildlife around the Great Lakes, often, were those animals that had grown up elsewhere and migrated as adults. When their offspring failed to reach adulthood, or couldn't reproduce, they were replaced by a fresh fleet of new arrivals. The lakes looked healthy, in other words, but they were a death trap. Colborn credited this breakthrough, in part, to her unconventional scientific background. I looked at it from an entirely different perspective. I looked at endocrinology differently. I began to look at toxicology. I was not trained in toxicology. I was trained in pharmacology until I went back to college to get my Ph.D. in my old age. Only then did I begin to sit in on toxicology courses. There is a reductionism in scientists, in the scientific community. I have never been a reductionist. I am always thinking about the big picture. My thesis committee for my Ph.D. will tell you that. They had trouble with me. At the time, Colborn said, scientists working on environmental issues had primarily been looking for cancer, which she described as "the big bugaboo." Cancer was a rare event: In order to emerge, it had to circumvent the body's defenses, and in a polluted community, not everyone would come down with it. What Colborn found was different: To a developing organism, even an infinitesimally small exposure could alter fetal development and the possible effects - lower IQ, organ damage, trouble reproducing - could be spread out across a community like jam on toast. The concept was so new there wasn't even a term for it. In 1991, Colborn and a team of 21 international scientists working on the issue came up with one: endocrine disruption. Unlike a lot of scientists, Colborn was not shy about becoming a public figure. She co-authored a popular science book with the dramatic title of Our Stolen Future. She founded a nonprofit called the Endocrine Disruption Exchange, which, among other things, helped fund and cheerlead more research into endocrine disruption and its causes. Colborn continued to do solid research and she also went pretty far out on quite a few limbs, blaming chemicals derived from fossil fuels for everything from Parkinsons to Alzheimers to obesity to autism spectrum disorder. "Governments must take heed immediately," she wrote, earlier this year, "or there will be too few healthy, intelligent individuals left to preserve our humanitarian society and create some semblance of world peace." (As if we don't have a pretty significant historical record showing that humans were more than eager to be complete jerks to each other long before anyone started messing with the benzene ring.) Still, her big message was incontestable - that over 60 years ago, we began to introduce all of these chemicals into the environment, and we still have no idea what most of them do to us. In raising these questions, Colburn got us closer to looking for answers. Laurie Tenace Environmental Specialist Waste Reduction Section Florida Department of Environmental Protection 2600 Blair Stone Road, MS 4555 Tallahassee, FL 32399-2400 850.245.8759 Laurie.Tenace@dep.state.fl.us -------------- next part -------------- An HTML attachment was scrubbed... URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141216/8dec5a92/attachment-0001.htm From bhanstrom at coloradomedicalwaste.com Tue Dec 16 11:57:56 2014 From: bhanstrom at coloradomedicalwaste.com (Beverly Hanstrom) Date: Tue Dec 16 11:58:11 2014 Subject: [Pharmwaste] RE: remembering Theo Colburn In-Reply-To: <01a5b4b0b772416193513102dae5a15e@CY1PR09MB0555.namprd09.prod.outlook.com> References: <01a5b4b0b772416193513102dae5a15e@CY1PR09MB0555.namprd09.prod.outlook.com> Message-ID: Laurie, Thank you for sharing this with the listserv group. Her loss is a reminder that we all have an opportunity to be champions for change. With joint collaboration of community, we can accomplish great things. I followed her work through this group and was inspired by her vision and commitment to expand her knowledge, graduating with her Ph.D. late into her 50's. She is a shining example that we are never too old to make a difference. We recently celebrated an example of joint collaboration with our 2014 Award for Environmental Sustainability. http://www.prnewswire.com/news-releases/colorado-medical-waste-receives-2014-business-recognition-award-for-environmental-sustainability-300009096.html Thank you Cleo for your inspiration, research and education, that we continue your work and carry the torch forward. Rest in peace. Regards, [cmw_logo_K] "Environmental Stewards for Medical Waste Disposal" Beverly Hanstrom, President 3131 Oakland St. Aurora, CO 80010-1508 (303) 794-5716 Office (303) 763-2339 Fax (720) 971-9716 Cell email bhanstrom@coloradomedicalwaste.com website http://www.coloradomedicalwaste.com [cid:image008.jpg@01D01916.C1D6F750][cid:image002.jpg@01CEA981.E23D5A30] From: pharmwaste-bounces@lists.dep.state.fl.us [mailto:pharmwaste-bounces@lists.dep.state.fl.us] On Behalf Of Tenace, Laurie Sent: Tuesday, December 16, 2014 6:05 AM To: 'pharmwaste@lists.dep.state.fl.us' Subject: [Pharmwaste] remembering Theo Colburn Remembering the genius who got BPA out of your water bottles, and so much more http://grist.org/business-technology/remembering-the-genius-who-got-bpa-out-of-your-water-bottles-and-so-much-more/ It was the late 1970s and Theo Colborn was, like pretty much everyone else in the '70s, getting divorced. She was in her 50s and already retired from a career as a pharmacist. She'd moved to a hobby farm that was close to the Rocky Mountain Biological Station in Colorado and volunteered as a field researcher, sampling water and insects for signs that they were picking up toxics released by mining operations in the area. When she thought about what she should do next with her life, the answer that came to her was "become an expert in water sampling techniques." So Colborn went back to school. In 1985, at 58, she graduated from the University of Wisconsin-Madison with a Ph.D. in zoology and minors in epidemiology, toxicology, and water chemistry. "I wanted to get the education," she said, in a 1988 Frontline interview,"so that I could maybe undo some of the things that my generation basically foisted on society." By the time Colborn died yesterday, at the age of 87, she had immersed herself in decades of research - and inspired even more research - that sought to do just that. The many, many proposed BPA bans? Go back to the very beginning, and you'll find Colborn. The concern over dwindling sperm counts? Same thing. After she graduated, Colborn went to work in Washington, D.C., first as a Congressional Fellow and then as an analyst, researching industrial emissions and ozone for the Clean Air Act. When those projects ended, she was hired by two conservation organizations, the World Wildlife Fund and The Conservation Foundation, to put together an overview of Great Lakes water quality with another researcher, Richard Liroff. In the Frontline interview, she talked about what happened next: I was working on a book on the state of the environment of the Great Lakes. And I pulled all this literature together, lots of papers, you know: fellows working in Canada, people working in the United States, one out on Lake Superior, others over, way over on Lake Ontario had done some work, written their papers, had them published in a number of different journals. None of them knew what the other was doing. And basically, I sat in a wonderful position where I pulled all this information together. And looking at it I said, "There is something wrong here." And the easiest thing for me to do is to use - thank goodness for computers - use a spreadsheet at a computer and start producing these spreadsheets. And as I plotted those names of the animals in the column on the left-hand side, this is called the "Y" column, and then on the "X" column I plotted the effects that were seen in the animals, it began to fall out that there were serious problems and actually population declines, population crashes, actually extirpation of some populations. They disappeared in some places. What Colborn was seeing was the result of a wide variety of synthetic chemicals that had come into being in the 1950s and '60s. Even though they were present in the water at very low concentrations, they were subtly changing how the animals in that system developed - how their genes were programmed, how their cells differentiated and spread out through their bodies, and, ultimately, how they were able to survive and reproduce into the next generation. The healthy wildlife around the Great Lakes, often, were those animals that had grown up elsewhere and migrated as adults. When their offspring failed to reach adulthood, or couldn't reproduce, they were replaced by a fresh fleet of new arrivals. The lakes looked healthy, in other words, but they were a death trap. Colborn credited this breakthrough, in part, to her unconventional scientific background. I looked at it from an entirely different perspective. I looked at endocrinology differently. I began to look at toxicology. I was not trained in toxicology. I was trained in pharmacology until I went back to college to get my Ph.D. in my old age. Only then did I begin to sit in on toxicology courses. There is a reductionism in scientists, in the scientific community. I have never been a reductionist. I am always thinking about the big picture. My thesis committee for my Ph.D. will tell you that. They had trouble with me. At the time, Colborn said, scientists working on environmental issues had primarily been looking for cancer, which she described as "the big bugaboo." Cancer was a rare event: In order to emerge, it had to circumvent the body's defenses, and in a polluted community, not everyone would come down with it. What Colborn found was different: To a developing organism, even an infinitesimally small exposure could alter fetal development and the possible effects - lower IQ, organ damage, trouble reproducing - could be spread out across a community like jam on toast. The concept was so new there wasn't even a term for it. In 1991, Colborn and a team of 21 international scientists working on the issue came up with one: endocrine disruption. Unlike a lot of scientists, Colborn was not shy about becoming a public figure. She co-authored a popular science book with the dramatic title of Our Stolen Future. She founded a nonprofit called the Endocrine Disruption Exchange, which, among other things, helped fund and cheerlead more research into endocrine disruption and its causes. Colborn continued to do solid research and she also went pretty far out on quite a few limbs, blaming chemicals derived from fossil fuels for everything from Parkinsons to Alzheimers to obesity to autism spectrum disorder. "Governments must take heed immediately," she wrote, earlier this year, "or there will be too few healthy, intelligent individuals left to preserve our humanitarian society and create some semblance of world peace." (As if we don't have a pretty significant historical record showing that humans were more than eager to be complete jerks to each other long before anyone started messing with the benzene ring.) Still, her big message was incontestable - that over 60 years ago, we began to introduce all of these chemicals into the environment, and we still have no idea what most of them do to us. In raising these questions, Colburn got us closer to looking for answers. Laurie Tenace Environmental Specialist Waste Reduction Section Florida Department of Environmental Protection 2600 Blair Stone Road, MS 4555 Tallahassee, FL 32399-2400 850.245.8759 Laurie.Tenace@dep.state.fl.us -------------- next part -------------- An HTML attachment was scrubbed... URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141216/466257d3/attachment.htm -------------- next part -------------- A non-text attachment was scrubbed... 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Name: image009.jpg Type: image/jpeg Size: 1449 bytes Desc: image009.jpg Url : http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141216/466257d3/image009.jpg From Laurie.Tenace at dep.state.fl.us Tue Dec 16 14:10:33 2014 From: Laurie.Tenace at dep.state.fl.us (Tenace, Laurie) Date: Tue Dec 16 14:17:16 2014 Subject: [Pharmwaste] Medicines in the Environment: A Growing Threat to Wildlife and Drinking Water - EU report Message-ID: http://www.chemtrust.org.uk/medicines-in-the-environment-a-growing-threat-to-wildlife-and-drinking-water/ Medicines in the Environment: A Growing Threat to Wildlife and Drinking Water by Michael Warhurst on December 7, 2014 There is increasing evidence that human and veterinary medicines are damaging wildlife, a new report launched today by the environmental charity CHEM Trust shows. The report "Pharmaceuticals in the Environment: A growing threat to our tap water and wildlife" highlights that medicines [1] are polluting rivers and have harmed wild birds and fish. Other species too have been affected, and people are also worryingly exposed. This report comes at a time of growing global concern about the environmental effects of pharmaceuticals. Later this month a United Nations Environment Programme (UNEP) meeting [2] will decide whether 'Pharmaceuticals in the Environment' should be recommended to be designated an emerging global policy issue. The author of the report, Gwynne Lyons, Director of Policy at CHEM Trust, said: "Most people would probably be surprised that in general they excrete between 30-90% of any medicine they take. With so many medicines now being found in our rivers, action on all fronts is needed to protect wildlife and drinking water." She added: "The long term implications of many highly active medicines in our environment may come back to haunt us. The current situation is mind-boggling with fish contaminated with the birth control pill, antidepressants (such as Prozac), sedatives, antibiotics, painkillers, anti-cancer drugs and goodness knows what else." The report, an extensive analysis of the scientific literature and government reports, finds that there is a lack of adequate controls: * 613 pharmaceuticals have been reported in the environment worldwide, but analytical detection methods are not even available for many of the thousands of medicines in use. * Rivers in the UK[3] (and in all regions of the world)[4] are now contaminated with many medicines. * In England, anti-inflammatories and pain killers (ibuprofen and diclofenac) have been found in fur taken from otters. * In Sweden, samples of perch fish were found to be contaminated with 23 pharmaceuticals, including antidepressants (such as Prozac), sedatives, antibiotics, painkillers and anti-cancer drugs. * Baltic Sea salmon has been found contaminated with ethinyl estradiol, used in the contraceptive pill. * Several medicines have been shown to harm laboratory animals at the levels found in the environment, but there is little monitoring for effects in wildlife.[5] * Assessments of the environmental risks from human medicines in use before 30th October 2005 were not required and are often absent. * Dozens of medicines have been found in samples of drinking water in EU countries with larger monitoring programmes (eg. in France, Sweden, Spain and Germany) (For UK see[6]). Yet legal standards for residues of medicines in rivers and drinking waters are lacking. The report by CHEM Trust concludes that individuals, companies and governments can all help to reduce this problem by ensuring that: * Unused medicines are disposed of at pharmacies and NOT by flushing them down the toilet * New medicines are designed so that they don't persist in the environment, and * Sewage treatment works are improved In addition, the European Union should strengthen laws relating to the pollution of rivers with pharmaceuticals, and there also needs to be better international coordination on this issue. For further details contact Gwynne Lyons, Director of Policy CHEM Trust, gwynne.lyons@chemtrust.org.uk Tel: 01603 507363 or 07944 422 898 * The launch of this report has been covered by the Sunday Times:"Painkillers put otters at risk", including this quote: Elizabeth Chadwick of the Cardiff University otter project, who is part of a three- year study looking at pharmaceuticals in otter tissue, said: "As the population grows and gets older, the level of pharmaceuticals being pumped into the environment is ever- increasing. It is one of the most serious threats to our environmental health." Last year a study by Chadwick showed bones in the reproductive organs of male otters had got lighter over time. She believes exposure to hormone-mimicking chemicals is to blame. "Most studies look at the effects of one chemical at a time. Individually you might say that it is unlikely to cause harm at low levels, but it is difficult to work out the effects of exposure to a cocktail of chemicals," she added. * The report has also been covered by Chemical Watch, Processing Magazine and Thames Anglers Conservancy. NOTES TO EDITORS NB: The now widely used US spellings of estrogen & estradiol are used in the report and press release rather than the traditional UK spellings of oestrogen & oestradiol. [1] Between 1990 and 2007 in the EU, the retail value of the market for prescription and non-prescription human medicines quadrupled (up to ?169.7 billion from ?38 billion). Global per capita consumption is increasing, a trend which looks set to continue with our ageing population. [2] The Open-ended Working Group of the International Conference on Chemicals Management, under SAICM (Strategic Approach to International Chemicals Management) meets in Geneva, 15-17 December 2014. See http://www.saicm.org/index.php?option=com_content&view=category&id=92&Itemid=487 [3] Several pharmaceutical compounds have been detected in some UK rivers, including: * ibuprofen; * mefenamic acid; * diclofenac (all three used for pain and inflammation) * propranolol (used for angina, high blood pressure and other heart problems); * dextropropoxyphene (a pain killer formerly prescribed as 'distalgesic'.); * erythromycin; * trimethoprim (both antibitiotics); * acetyl sulfamethoxazole (a metabolite of the antibiotic sulfamethoxazole). A larger monitoring programme is planned for England and Wales in 2015 (see p12 of the report). [4] Over a dozen pharmaceuticals have been reported in the environment at many locations worldwide, including: * diclofenac (for pain and inflammation); * carbamazepine (an anti-epileptic); * ibuprofen (for pain and inflammation); * sulphamethazole (an antibiotic); * naproxen (for pain and inflammation); * trimethoprim (an antibiotic); * paracetamol (for pain); * clofibric acid (from the lipid lowering drug); * ciprofloxacin (an antibiotic); * ofloxacin (an antibiotic); * norfloxacin (an antibiotic); * acetylsalicylic acid (aspirin, a pain killer); * as well as residues of estrogenic substances, used in the contraceptive pill and to treat the menopause [5] Concerns about effects on wildlife include - but are not limited to - the following: * Ethinyl estradiol (from the contraceptive pill and to treat the menopause): At many locations downstream of sewage treatment works, male fish have been feminised and have reduced sperm production. Many of these male fish abnormally make the female egg yolk protein and have eggs in their testes. Research has shown that ethinyl estradiol has contributed to causing these effects, often in combination with other hormones or hormone mimicking substance. * Diclofenac (an anti-inflammatory): In Asia, diclofenac caused the death of thousands upon thousands of vultures between 1996 and 2007. Diclofenac was mainly given to cattle for relief of pain and inflammation associated with disease or wounds. As the meat of cattle is not eaten by people in India, vultures would feast on them and take up all remaining diclofenac residues. Fish and other wildlife species may also be under threat from diclofenac, because concentrations in many rivers worldwide on occasion exceed the predicted no effect concentration. In the UK, a recent research paper, using modelled data and comparing with actual available data, suggested that this level might be exceeded in 4.5% of river reaches. Also, for example, a laboratory study has noted that environmentally realistic concentrations of diclofenac can impair osmo-regulation in the shore crab (Carcinus maenas). * Ibuprofen (an anti-inflammatory and analgesic): Recent research has suggested that ibuprofen poses an unacceptable risk in 49.5% of river reaches across 22 catchments in Britain. Ibuprofen has been reported to have a number of effects in laboratory studies. For example, in studies on effects on fish reproduction, ibuprofen was reported to cause male fish to abnormally make the female egg yolk protein, vitellogenin, and parental exposure to levels as low as 0.0001 mg/L ibuprofen delayed the hatching of eggs, an effect which can increase the risk of predation. * Medicines used to treat parasites: Ivermectin is a veterinary drug that has caused effects in the wild. It is excreted in the faeces of treated animals and adversely affects invertebrate organisms that live in or feed on dung. It can therefore also reduce the amount of food available to birds and bats. Pharmaceuticals used to treat sea-lice parasites in fish farms can also cause environmental damage. For example, emamectin benzoate is widely used in the Scottish salmon farming industry, and is highly toxic to marine crustacean. There are some anecdotal reports of harm to wild shellfish. For example, dead and dying Nephrops (also known as the Norway lobster or Dublin Bay prawn) were reported in Loch Shell following sea-lice treatments. * Antidepressants: There is strong evidence to suggest that antidepressant pharmaceuticals are affecting aquatic invertebrates at concentrations now commonly found in the environment. Effects reported in laboratory studies include altered spawning and larval release in bivalves - disrupted locomotion and reduced fecundity in snails - altered behaviour in freshwater and marine amphipod - altered aggressive behaviour in crayfish - altered learning in cuttlefish - and in daphnia (water fleas) altered reproduction and development. However, more research is needed to confirm some of the concerns and to find out just what effects antidepressants are causing in the wild. * Oxazepam (a benzodiazepine sedative): This tranquilliser is reported to alter behaviour and feeding rate of wild European perch at concentrations encountered in effluent-influenced surface waters. The perch exhibited increased activity, reduced sociality and higher feeding rate. * Antibiotics: These can cause harm to environmental bacteria and algae. For example, environmental concentrations of chlortetracycline are in the range that inhibit the protein biosynthesis activity of planktonic bacterial communities. Also, for example, an EU funded research project (PHARMAS) has also highlighted that model predictions show that ciprofoxacin and levofloxacin (used for urinary tract infections) in some European rivers may approach concentration levels that could trigger ecological damage. * Clofibric acid (a metabolite of medicines used to regulate lipid): This is reported to cause effects on reproduction in fish, including detrimental effects on fish sperm. Some of these reproductive effects occurred only at a high levels, but others occurred at levels near or similar to those reported in rivers. [6] A small study of tap water in 2011 (in England and Wales) was focussed on looking for just 16 pharmaceuticals in drinking water. It found the following medicines were present: * Carbamazepine (an anticonvulsant used for epilepsy) * Ibuprofen (used for pain and inflammation) * Naproxen (used for pain and inflammation * Benzoylecgonine (a metabolite of cocaine). In more extensive monitoring studies of tap water carried out in other EU countries between 31 and 50 pharmaceuticals have been reported. Laurie Tenace Environmental Specialist Waste Reduction Section Florida Department of Environmental Protection 2600 Blair Stone Road, MS 4555 Tallahassee, FL 32399-2400 850.245.8759 Laurie.Tenace@dep.state.fl.us -------------- next part -------------- An HTML attachment was scrubbed... URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141216/95b9960d/attachment.htm From bhanstrom at coloradomedicalwaste.com Tue Dec 16 18:07:18 2014 From: bhanstrom at coloradomedicalwaste.com (Beverly Hanstrom) Date: Tue Dec 16 18:19:39 2014 Subject: [Pharmwaste] Medicines in the Environment: A Growing Threat to Wildlife and Drinking Water - EU report In-Reply-To: <24D2A3DBD4377240A1B613A8B5293DBD1F40DF7F@MBX029-E1-VA-8.EXCH029.DOMAIN.LOCAL> References: <24D2A3DBD4377240A1B613A8B5293DBD1F40DF7F@MBX029-E1-VA-8.EXCH029.DOMAIN.LOCAL> Message-ID: Hi Heidi/Laurie/listserv groups, Is there a way to gather consensus in support of designating an emerging global policy for ?Pharmaceuticals in the Environment? at the upcoming UNEP meeting? Are there any developers out there that can construct a page that can be distributed amongst us that we can add our names to? Organized support is pretty hard to ignore. Regards, [cmw_logo_K] ?Environmental Stewards for Medical Waste Disposal? Beverly Hanstrom, President 3131 Oakland St. Aurora, CO 80010-1508 (303) 794-5716 Office (303) 763-2339 Fax (720) 971-9716 Cell email bhanstrom@coloradomedicalwaste.com website http://www.coloradomedicalwaste.com [cid:image008.jpg@01D0194A.5B83E830][cid:image002.jpg@01CEA981.E23D5A30] From: cpsc-pharmaceuticals-listserv@googlegroups.com [mailto:cpsc-pharmaceuticals-listserv@googlegroups.com] On Behalf Of Heidi Sanborn Sent: Tuesday, December 16, 2014 12:41 PM To: CPSC Pharmaceutical Listserv (cpsc-pharmaceuticals-listserv@googlegroups.com) Subject: FW: [Pharmwaste] Medicines in the Environment: A Growing Threat to Wildlife and Drinking Water - EU report According to this article, ?Later this month a United Nations Environment Programme (UNEP) meeting [2] will decide whether ?Pharmaceuticals in the Environment? should be recommended to be designated an emerging global policy issue.? Heidi From: pharmwaste-bounces@lists.dep.state.fl.us [mailto:pharmwaste-bounces@lists.dep.state.fl.us] On Behalf Of Tenace, Laurie Sent: Tuesday, December 16, 2014 11:11 AM To: 'pharmwaste@lists.dep.state.fl.us' Subject: [Pharmwaste] Medicines in the Environment: A Growing Threat to Wildlife and Drinking Water - EU report http://www.chemtrust.org.uk/medicines-in-the-environment-a-growing-threat-to-wildlife-and-drinking-water/ Medicines in the Environment: A Growing Threat to Wildlife and Drinking Water by Michael Warhurst on December 7, 2014 There is increasing evidence that human and veterinary medicines are damaging wildlife, a new report launched today by the environmental charity CHEM Trust shows. The report ?Pharmaceuticals in the Environment: A growing threat to our tap water and wildlife? highlights that medicines [1] are polluting rivers and have harmed wild birds and fish. Other species too have been affected, and people are also worryingly exposed. This report comes at a time of growing global concern about the environmental effects of pharmaceuticals. Later this month a United Nations Environment Programme (UNEP) meeting [2] will decide whether ?Pharmaceuticals in the Environment? should be recommended to be designated an emerging global policy issue. The author of the report, Gwynne Lyons, Director of Policy at CHEM Trust, said: ?Most people would probably be surprised that in general they excrete between 30-90% of any medicine they take. With so many medicines now being found in our rivers, action on all fronts is needed to protect wildlife and drinking water.? She added: ?The long term implications of many highly active medicines in our environment may come back to haunt us. The current situation is mind-boggling with fish contaminated with the birth control pill, antidepressants (such as Prozac), sedatives, antibiotics, painkillers, anti-cancer drugs and goodness knows what else.? The report, an extensive analysis of the scientific literature and government reports, finds that there is a lack of adequate controls: * 613 pharmaceuticals have been reported in the environment worldwide, but analytical detection methods are not even available for many of the thousands of medicines in use. * Rivers in the UK[3] (and in all regions of the world)[4] are now contaminated with many medicines. * In England, anti-inflammatories and pain killers (ibuprofen and diclofenac) have been found in fur taken from otters. * In Sweden, samples of perch fish were found to be contaminated with 23 pharmaceuticals, including antidepressants (such as Prozac), sedatives, antibiotics, painkillers and anti-cancer drugs. * Baltic Sea salmon has been found contaminated with ethinyl estradiol, used in the contraceptive pill. * Several medicines have been shown to harm laboratory animals at the levels found in the environment, but there is little monitoring for effects in wildlife.[5] * Assessments of the environmental risks from human medicines in use before 30th October 2005 were not required and are often absent. * Dozens of medicines have been found in samples of drinking water in EU countries with larger monitoring programmes (eg. in France, Sweden, Spain and Germany) (For UK see[6]). Yet legal standards for residues of medicines in rivers and drinking waters are lacking. The report by CHEM Trust concludes that individuals, companies and governments can all help to reduce this problem by ensuring that: * Unused medicines are disposed of at pharmacies and NOT by flushing them down the toilet * New medicines are designed so that they don?t persist in the environment, and * Sewage treatment works are improved In addition, the European Union should strengthen laws relating to the pollution of rivers with pharmaceuticals, and there also needs to be better international coordination on this issue. For further details contact Gwynne Lyons, Director of Policy CHEM Trust, gwynne.lyons@chemtrust.org.uk Tel: 01603 507363 or 07944 422 898 * The launch of this report has been covered by the Sunday Times:?Painkillers put otters at risk?, including this quote: Elizabeth Chadwick of the Cardiff University otter project, who is part of a three- year study looking at pharmaceuticals in otter tissue, said: ?As the population grows and gets older, the level of pharmaceuticals being pumped into the environment is ever- increasing. It is one of the most serious threats to our environmental health.? Last year a study by Chadwick showed bones in the reproductive organs of male otters had got lighter over time. She believes exposure to hormone-mimicking chemicals is to blame. ?Most studies look at the effects of one chemical at a time. Individually you might say that it is unlikely to cause harm at low levels, but it is difficult to work out the effects of exposure to a cocktail of chemicals,? she added. * The report has also been covered by Chemical Watch, Processing Magazine and Thames Anglers Conservancy. NOTES TO EDITORS NB: The now widely used US spellings of estrogen & estradiol are used in the report and press release rather than the traditional UK spellings of oestrogen & oestradiol. [1] Between 1990 and 2007 in the EU, the retail value of the market for prescription and non-prescription human medicines quadrupled (up to ?169.7 billion from ?38 billion). Global per capita consumption is increasing, a trend which looks set to continue with our ageing population. [2] The Open-ended Working Group of the International Conference on Chemicals Management, under SAICM (Strategic Approach to International Chemicals Management) meets in Geneva, 15?17 December 2014. See http://www.saicm.org/index.php?option=com_content&view=category&id=92&Itemid=487 [3] Several pharmaceutical compounds have been detected in some UK rivers, including: * ibuprofen; * mefenamic acid; * diclofenac (all three used for pain and inflammation) * propranolol (used for angina, high blood pressure and other heart problems); * dextropropoxyphene (a pain killer formerly prescribed as ?distalgesic?.); * erythromycin; * trimethoprim (both antibitiotics); * acetyl sulfamethoxazole (a metabolite of the antibiotic sulfamethoxazole). A larger monitoring programme is planned for England and Wales in 2015 (see p12 of the report). [4] Over a dozen pharmaceuticals have been reported in the environment at many locations worldwide, including: * diclofenac (for pain and inflammation); * carbamazepine (an anti-epileptic); * ibuprofen (for pain and inflammation); * sulphamethazole (an antibiotic); * naproxen (for pain and inflammation); * trimethoprim (an antibiotic); * paracetamol (for pain); * clofibric acid (from the lipid lowering drug); * ciprofloxacin (an antibiotic); * ofloxacin (an antibiotic); * norfloxacin (an antibiotic); * acetylsalicylic acid (aspirin, a pain killer); * as well as residues of estrogenic substances, used in the contraceptive pill and to treat the menopause [5] Concerns about effects on wildlife include ? but are not limited to ? the following: * Ethinyl estradiol (from the contraceptive pill and to treat the menopause): At many locations downstream of sewage treatment works, male fish have been feminised and have reduced sperm production. Many of these male fish abnormally make the female egg yolk protein and have eggs in their testes. Research has shown that ethinyl estradiol has contributed to causing these effects, often in combination with other hormones or hormone mimicking substance. * Diclofenac (an anti-inflammatory): In Asia, diclofenac caused the death of thousands upon thousands of vultures between 1996 and 2007. Diclofenac was mainly given to cattle for relief of pain and inflammation associated with disease or wounds. As the meat of cattle is not eaten by people in India, vultures would feast on them and take up all remaining diclofenac residues. Fish and other wildlife species may also be under threat from diclofenac, because concentrations in many rivers worldwide on occasion exceed the predicted no effect concentration. In the UK, a recent research paper, using modelled data and comparing with actual available data, suggested that this level might be exceeded in 4.5% of river reaches. Also, for example, a laboratory study has noted that environmentally realistic concentrations of diclofenac can impair osmo-regulation in the shore crab (Carcinus maenas). * Ibuprofen (an anti-inflammatory and analgesic): Recent research has suggested that ibuprofen poses an unacceptable risk in 49.5% of river reaches across 22 catchments in Britain. Ibuprofen has been reported to have a number of effects in laboratory studies. For example, in studies on effects on fish reproduction, ibuprofen was reported to cause male fish to abnormally make the female egg yolk protein, vitellogenin, and parental exposure to levels as low as 0.0001 mg/L ibuprofen delayed the hatching of eggs, an effect which can increase the risk of predation. * Medicines used to treat parasites: Ivermectin is a veterinary drug that has caused effects in the wild. It is excreted in the faeces of treated animals and adversely affects invertebrate organisms that live in or feed on dung. It can therefore also reduce the amount of food available to birds and bats. Pharmaceuticals used to treat sea-lice parasites in fish farms can also cause environmental damage. For example, emamectin benzoate is widely used in the Scottish salmon farming industry, and is highly toxic to marine crustacean. There are some anecdotal reports of harm to wild shellfish. For example, dead and dying Nephrops (also known as the Norway lobster or Dublin Bay prawn) were reported in Loch Shell following sea-lice treatments. * Antidepressants: There is strong evidence to suggest that antidepressant pharmaceuticals are affecting aquatic invertebrates at concentrations now commonly found in the environment. Effects reported in laboratory studies include altered spawning and larval release in bivalves ? disrupted locomotion and reduced fecundity in snails ? altered behaviour in freshwater and marine amphipod ? altered aggressive behaviour in crayfish ? altered learning in cuttlefish ? and in daphnia (water fleas) altered reproduction and development. However, more research is needed to confirm some of the concerns and to find out just what effects antidepressants are causing in the wild. * Oxazepam (a benzodiazepine sedative): This tranquilliser is reported to alter behaviour and feeding rate of wild European perch at concentrations encountered in effluent-influenced surface waters. The perch exhibited increased activity, reduced sociality and higher feeding rate. * Antibiotics: These can cause harm to environmental bacteria and algae. For example, environmental concentrations of chlortetracycline are in the range that inhibit the protein biosynthesis activity of planktonic bacterial communities. Also, for example, an EU funded research project (PHARMAS) has also highlighted that model predictions show that ciprofoxacin and levofloxacin (used for urinary tract infections) in some European rivers may approach concentration levels that could trigger ecological damage. * Clofibric acid (a metabolite of medicines used to regulate lipid): This is reported to cause effects on reproduction in fish, including detrimental effects on fish sperm. Some of these reproductive effects occurred only at a high levels, but others occurred at levels near or similar to those reported in rivers. [6] A small study of tap water in 2011 (in England and Wales) was focussed on looking for just 16 pharmaceuticals in drinking water. It found the following medicines were present: * Carbamazepine (an anticonvulsant used for epilepsy) * Ibuprofen (used for pain and inflammation) * Naproxen (used for pain and inflammation * Benzoylecgonine (a metabolite of cocaine). In more extensive monitoring studies of tap water carried out in other EU countries between 31 and 50 pharmaceuticals have been reported. Laurie Tenace Environmental Specialist Waste Reduction Section Florida Department of Environmental Protection 2600 Blair Stone Road, MS 4555 Tallahassee, FL 32399-2400 850.245.8759 Laurie.Tenace@dep.state.fl.us -- --- You received this message because you are subscribed to the Google Groups "CPSC Pharmaceuticals Stewardship Bill Listserv" group. To unsubscribe from this group and stop receiving emails from it, send an email to cpsc-pharmaceuticals-listserv+unsubscribe@googlegroups.com. For more options, visit https://groups.google.com/d/optout. -------------- next part -------------- An HTML attachment was scrubbed... URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141216/6f55275c/attachment-0001.htm -------------- next part -------------- A non-text attachment was scrubbed... Name: image007.png Type: image/png Size: 6027 bytes Desc: image007.png Url : http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141216/6f55275c/image007-0001.png -------------- next part -------------- A non-text attachment was scrubbed... Name: image008.jpg Type: image/jpeg Size: 4437 bytes Desc: image008.jpg Url : http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141216/6f55275c/image008-0001.jpg -------------- next part -------------- A non-text attachment was scrubbed... Name: image009.jpg Type: image/jpeg Size: 1450 bytes Desc: image009.jpg Url : http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141216/6f55275c/image009-0001.jpg From DNKing at lincoln.ne.gov Wed Dec 17 11:48:01 2014 From: DNKing at lincoln.ne.gov (Dan N. King) Date: Wed Dec 17 11:49:22 2014 Subject: [Pharmwaste] Medicines in the Environment: A Growing Threat to Wildlife and Drinking Water - EU report In-Reply-To: References: <24D2A3DBD4377240A1B613A8B5293DBD1F40DF7F@MBX029-E1-VA-8.EXCH029.DOMAIN.LOCAL> Message-ID: Beverly and All, Great question. Perhaps the Product Stewardship Institute (PSI) or the North American Hazardous Material Management Assn. (NAHMMA) could champion such an effort? Be well, be safe! Dan Dan N. King Environmental Health Specialist II Coordinator, Toxics-Reduction Program Lincoln-Lancaster County Health Department 3140 N Street Lincoln, NE 68510 (402) 441.8084 Desk (402) 430.4897 Cell dnking@lincoln.ne.gov www.nebraskameds.org [cid:image003.jpg@01CEDAC7.FAEDF950] From: pharmwaste-bounces@lists.dep.state.fl.us [mailto:pharmwaste-bounces@lists.dep.state.fl.us] On Behalf Of Beverly Hanstrom Sent: Tuesday, December 16, 2014 5:07 PM To: cpsc-pharmaceuticals-listserv@googlegroups.com; 'pharmwaste@lists.dep.state.fl.us' Subject: RE: [Pharmwaste] Medicines in the Environment: A Growing Threat to Wildlife and Drinking Water - EU report Hi Heidi/Laurie/listserv groups, Is there a way to gather consensus in support of designating an emerging global policy for ?Pharmaceuticals in the Environment? at the upcoming UNEP meeting? Are there any developers out there that can construct a page that can be distributed amongst us that we can add our names to? Organized support is pretty hard to ignore. Regards, [cmw_logo_K] ?Environmental Stewards for Medical Waste Disposal? Beverly Hanstrom, President 3131 Oakland St. Aurora, CO 80010-1508 (303) 794-5716 Office (303) 763-2339 Fax (720) 971-9716 Cell email bhanstrom@coloradomedicalwaste.com website http://www.coloradomedicalwaste.com [cid:image003.jpg@01D019E6.EC3DF400][cid:image002.jpg@01CEA981.E23D5A30] From: cpsc-pharmaceuticals-listserv@googlegroups.com [mailto:cpsc-pharmaceuticals-listserv@googlegroups.com] On Behalf Of Heidi Sanborn Sent: Tuesday, December 16, 2014 12:41 PM To: CPSC Pharmaceutical Listserv (cpsc-pharmaceuticals-listserv@googlegroups.com) Subject: FW: [Pharmwaste] Medicines in the Environment: A Growing Threat to Wildlife and Drinking Water - EU report According to this article, ?Later this month a United Nations Environment Programme (UNEP) meeting [2] will decide whether ?Pharmaceuticals in the Environment? should be recommended to be designated an emerging global policy issue.? Heidi From: pharmwaste-bounces@lists.dep.state.fl.us [mailto:pharmwaste-bounces@lists.dep.state.fl.us] On Behalf Of Tenace, Laurie Sent: Tuesday, December 16, 2014 11:11 AM To: 'pharmwaste@lists.dep.state.fl.us' Subject: [Pharmwaste] Medicines in the Environment: A Growing Threat to Wildlife and Drinking Water - EU report http://www.chemtrust.org.uk/medicines-in-the-environment-a-growing-threat-to-wildlife-and-drinking-water/ Medicines in the Environment: A Growing Threat to Wildlife and Drinking Water by Michael Warhurst on December 7, 2014 There is increasing evidence that human and veterinary medicines are damaging wildlife, a new report launched today by the environmental charity CHEM Trust shows. The report ?Pharmaceuticals in the Environment: A growing threat to our tap water and wildlife? highlights that medicines [1] are polluting rivers and have harmed wild birds and fish. Other species too have been affected, and people are also worryingly exposed. This report comes at a time of growing global concern about the environmental effects of pharmaceuticals. Later this month a United Nations Environment Programme (UNEP) meeting [2] will decide whether ?Pharmaceuticals in the Environment? should be recommended to be designated an emerging global policy issue. The author of the report, Gwynne Lyons, Director of Policy at CHEM Trust, said: ?Most people would probably be surprised that in general they excrete between 30-90% of any medicine they take. With so many medicines now being found in our rivers, action on all fronts is needed to protect wildlife and drinking water.? She added: ?The long term implications of many highly active medicines in our environment may come back to haunt us. The current situation is mind-boggling with fish contaminated with the birth control pill, antidepressants (such as Prozac), sedatives, antibiotics, painkillers, anti-cancer drugs and goodness knows what else.? The report, an extensive analysis of the scientific literature and government reports, finds that there is a lack of adequate controls: * 613 pharmaceuticals have been reported in the environment worldwide, but analytical detection methods are not even available for many of the thousands of medicines in use. * Rivers in the UK[3] (and in all regions of the world)[4] are now contaminated with many medicines. * In England, anti-inflammatories and pain killers (ibuprofen and diclofenac) have been found in fur taken from otters. * In Sweden, samples of perch fish were found to be contaminated with 23 pharmaceuticals, including antidepressants (such as Prozac), sedatives, antibiotics, painkillers and anti-cancer drugs. * Baltic Sea salmon has been found contaminated with ethinyl estradiol, used in the contraceptive pill. * Several medicines have been shown to harm laboratory animals at the levels found in the environment, but there is little monitoring for effects in wildlife.[5] * Assessments of the environmental risks from human medicines in use before 30th October 2005 were not required and are often absent. * Dozens of medicines have been found in samples of drinking water in EU countries with larger monitoring programmes (eg. in France, Sweden, Spain and Germany) (For UK see[6]). Yet legal standards for residues of medicines in rivers and drinking waters are lacking. The report by CHEM Trust concludes that individuals, companies and governments can all help to reduce this problem by ensuring that: * Unused medicines are disposed of at pharmacies and NOT by flushing them down the toilet * New medicines are designed so that they don?t persist in the environment, and * Sewage treatment works are improved In addition, the European Union should strengthen laws relating to the pollution of rivers with pharmaceuticals, and there also needs to be better international coordination on this issue. For further details contact Gwynne Lyons, Director of Policy CHEM Trust, gwynne.lyons@chemtrust.org.uk Tel: 01603 507363 or 07944 422 898 * The launch of this report has been covered by the Sunday Times:?Painkillers put otters at risk?, including this quote: Elizabeth Chadwick of the Cardiff University otter project, who is part of a three- year study looking at pharmaceuticals in otter tissue, said: ?As the population grows and gets older, the level of pharmaceuticals being pumped into the environment is ever- increasing. It is one of the most serious threats to our environmental health.? Last year a study by Chadwick showed bones in the reproductive organs of male otters had got lighter over time. She believes exposure to hormone-mimicking chemicals is to blame. ?Most studies look at the effects of one chemical at a time. Individually you might say that it is unlikely to cause harm at low levels, but it is difficult to work out the effects of exposure to a cocktail of chemicals,? she added. * The report has also been covered by Chemical Watch, Processing Magazine and Thames Anglers Conservancy. NOTES TO EDITORS NB: The now widely used US spellings of estrogen & estradiol are used in the report and press release rather than the traditional UK spellings of oestrogen & oestradiol. [1] Between 1990 and 2007 in the EU, the retail value of the market for prescription and non-prescription human medicines quadrupled (up to ?169.7 billion from ?38 billion). Global per capita consumption is increasing, a trend which looks set to continue with our ageing population. [2] The Open-ended Working Group of the International Conference on Chemicals Management, under SAICM (Strategic Approach to International Chemicals Management) meets in Geneva, 15?17 December 2014. See http://www.saicm.org/index.php?option=com_content&view=category&id=92&Itemid=487 [3] Several pharmaceutical compounds have been detected in some UK rivers, including: * ibuprofen; * mefenamic acid; * diclofenac (all three used for pain and inflammation) * propranolol (used for angina, high blood pressure and other heart problems); * dextropropoxyphene (a pain killer formerly prescribed as ?distalgesic?.); * erythromycin; * trimethoprim (both antibitiotics); * acetyl sulfamethoxazole (a metabolite of the antibiotic sulfamethoxazole). A larger monitoring programme is planned for England and Wales in 2015 (see p12 of the report). [4] Over a dozen pharmaceuticals have been reported in the environment at many locations worldwide, including: * diclofenac (for pain and inflammation); * carbamazepine (an anti-epileptic); * ibuprofen (for pain and inflammation); * sulphamethazole (an antibiotic); * naproxen (for pain and inflammation); * trimethoprim (an antibiotic); * paracetamol (for pain); * clofibric acid (from the lipid lowering drug); * ciprofloxacin (an antibiotic); * ofloxacin (an antibiotic); * norfloxacin (an antibiotic); * acetylsalicylic acid (aspirin, a pain killer); * as well as residues of estrogenic substances, used in the contraceptive pill and to treat the menopause [5] Concerns about effects on wildlife include ? but are not limited to ? the following: * Ethinyl estradiol (from the contraceptive pill and to treat the menopause): At many locations downstream of sewage treatment works, male fish have been feminised and have reduced sperm production. Many of these male fish abnormally make the female egg yolk protein and have eggs in their testes. Research has shown that ethinyl estradiol has contributed to causing these effects, often in combination with other hormones or hormone mimicking substance. * Diclofenac (an anti-inflammatory): In Asia, diclofenac caused the death of thousands upon thousands of vultures between 1996 and 2007. Diclofenac was mainly given to cattle for relief of pain and inflammation associated with disease or wounds. As the meat of cattle is not eaten by people in India, vultures would feast on them and take up all remaining diclofenac residues. Fish and other wildlife species may also be under threat from diclofenac, because concentrations in many rivers worldwide on occasion exceed the predicted no effect concentration. In the UK, a recent research paper, using modelled data and comparing with actual available data, suggested that this level might be exceeded in 4.5% of river reaches. Also, for example, a laboratory study has noted that environmentally realistic concentrations of diclofenac can impair osmo-regulation in the shore crab (Carcinus maenas). * Ibuprofen (an anti-inflammatory and analgesic): Recent research has suggested that ibuprofen poses an unacceptable risk in 49.5% of river reaches across 22 catchments in Britain. Ibuprofen has been reported to have a number of effects in laboratory studies. For example, in studies on effects on fish reproduction, ibuprofen was reported to cause male fish to abnormally make the female egg yolk protein, vitellogenin, and parental exposure to levels as low as 0.0001 mg/L ibuprofen delayed the hatching of eggs, an effect which can increase the risk of predation. * Medicines used to treat parasites: Ivermectin is a veterinary drug that has caused effects in the wild. It is excreted in the faeces of treated animals and adversely affects invertebrate organisms that live in or feed on dung. It can therefore also reduce the amount of food available to birds and bats. Pharmaceuticals used to treat sea-lice parasites in fish farms can also cause environmental damage. For example, emamectin benzoate is widely used in the Scottish salmon farming industry, and is highly toxic to marine crustacean. There are some anecdotal reports of harm to wild shellfish. For example, dead and dying Nephrops (also known as the Norway lobster or Dublin Bay prawn) were reported in Loch Shell following sea-lice treatments. * Antidepressants: There is strong evidence to suggest that antidepressant pharmaceuticals are affecting aquatic invertebrates at concentrations now commonly found in the environment. Effects reported in laboratory studies include altered spawning and larval release in bivalves ? disrupted locomotion and reduced fecundity in snails ? altered behaviour in freshwater and marine amphipod ? altered aggressive behaviour in crayfish ? altered learning in cuttlefish ? and in daphnia (water fleas) altered reproduction and development. However, more research is needed to confirm some of the concerns and to find out just what effects antidepressants are causing in the wild. * Oxazepam (a benzodiazepine sedative): This tranquilliser is reported to alter behaviour and feeding rate of wild European perch at concentrations encountered in effluent-influenced surface waters. The perch exhibited increased activity, reduced sociality and higher feeding rate. * Antibiotics: These can cause harm to environmental bacteria and algae. For example, environmental concentrations of chlortetracycline are in the range that inhibit the protein biosynthesis activity of planktonic bacterial communities. Also, for example, an EU funded research project (PHARMAS) has also highlighted that model predictions show that ciprofoxacin and levofloxacin (used for urinary tract infections) in some European rivers may approach concentration levels that could trigger ecological damage. * Clofibric acid (a metabolite of medicines used to regulate lipid): This is reported to cause effects on reproduction in fish, including detrimental effects on fish sperm. Some of these reproductive effects occurred only at a high levels, but others occurred at levels near or similar to those reported in rivers. [6] A small study of tap water in 2011 (in England and Wales) was focussed on looking for just 16 pharmaceuticals in drinking water. It found the following medicines were present: * Carbamazepine (an anticonvulsant used for epilepsy) * Ibuprofen (used for pain and inflammation) * Naproxen (used for pain and inflammation * Benzoylecgonine (a metabolite of cocaine). In more extensive monitoring studies of tap water carried out in other EU countries between 31 and 50 pharmaceuticals have been reported. Laurie Tenace Environmental Specialist Waste Reduction Section Florida Department of Environmental Protection 2600 Blair Stone Road, MS 4555 Tallahassee, FL 32399-2400 850.245.8759 Laurie.Tenace@dep.state.fl.us -- --- You received this message because you are subscribed to the Google Groups "CPSC Pharmaceuticals Stewardship Bill Listserv" group. To unsubscribe from this group and stop receiving emails from it, send an email to cpsc-pharmaceuticals-listserv+unsubscribe@googlegroups.com. For more options, visit https://groups.google.com/d/optout. ________________________________ CONFIDENTIALITY NOTICE: This e-mail message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message. -------------- next part -------------- An HTML attachment was scrubbed... URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141217/709e7b38/attachment-0001.html -------------- next part -------------- A non-text attachment was scrubbed... Name: image001.jpg Type: image/jpeg Size: 4137 bytes Desc: image001.jpg Url : http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141217/709e7b38/image001-0001.jpg -------------- next part -------------- A non-text attachment was scrubbed... Name: image002.png Type: image/png Size: 6027 bytes Desc: image002.png Url : http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141217/709e7b38/image002-0001.png -------------- next part -------------- A non-text attachment was scrubbed... Name: image003.jpg Type: image/jpeg Size: 4437 bytes Desc: image003.jpg Url : http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141217/709e7b38/image003-0001.jpg -------------- next part -------------- A non-text attachment was scrubbed... Name: image004.jpg Type: image/jpeg Size: 1450 bytes Desc: image004.jpg Url : http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141217/709e7b38/image004-0001.jpg From Laurie.Tenace at dep.state.fl.us Fri Dec 19 08:03:09 2014 From: Laurie.Tenace at dep.state.fl.us (Tenace, Laurie) Date: Fri Dec 19 08:05:36 2014 Subject: [Pharmwaste] Drug pollution risk 'a global responsibility' Message-ID: <900d5ebd05db4774b310b578ddc66b02@CY1PR09MB0555.namprd09.prod.outlook.com> http://www.abc.net.au/science/articles/2014/12/18/4145868.htm Drug pollution risk 'a global responsibility' Thursday, 18 December 2014 Anna Salleh ABC ________________________________ [pharmaceutical company] A growing percentage of the world's generic drugs is made in plants like this one in India (iStockphoto: Ajay Verma) Related Stories * Antibiotics flushed into waterways, Science Online, 17 Mar 2005 * Call for control of nano-silver use, Science Online, 20 Oct 2009 Pharmaceutical legacy Rich countries should help poorer countries deal with the risk posed by pharmaceutical contamination of the environment, says an Australian expert. Dr Rai Kookana, an environmental chemist with the CSIRO, made the comments following the release of a study published in a recent issue of Philosophical Transactions of the Royal Society B. The study is the first to compare the risk of pollution from drugs, including antibiotics, anti-inflammatories and antidepressants, in high-income and lower-income countries around the world. Kookana and colleagues gathered data on factors such as demographics, the manufacture and consumption of pharmaceuticals, and the quality of waste and wastewater systems to assess the potential risk from pharmaceuticals in 17 countries. They found that countries like China and India are at greater risk than higher-income countries, of groundwater, land and river contamination from the active ingredients of drugs. Drug manufacturing Kookana says poor waste and waste water systems are key factors contributing to pollution in lower-income countries. "Historically, when drugs are brought on to the market, the environment doesn't come into the picture at all. But obviously the drugs find their way into the environment through the waste stream," he says. Major "point sources" of contamination are drug manufacturing facilities, which are increasingly being moved to poorer countries, where labour costs are lower, he adds. "There is some evidence from China and India that effluents from drug manufacturing plants contain high concentrations of antibiotics and other drugs including antidepressants and NSAIDs (non-steroidal anti-inflammatory drugs)," says Kookana. "The rivers and lakes receiving these effluents have been found to be contaminated with these drugs." He says a 2007 Swedish study found drug concentrations in a river adjacent to one drug manufacturing area exceeded the therapeutic levels in humans. Drugged vultures Previous research has shown that some pharmaceuticals are known to persist in the environment and there is evidence they affect animals, says Kookana. For example, a 2004 paper in Nature blamed a crash in vulture numbers on the Indian subcontinent on pollution from the anti-inflammatory drug diclofenac. "There is also some evidence that antidepressants such as fluoxetine can cause behavioural problems in fish, water fleas and birds," he adds. And his own research has shown the mood stabiliser and anti-epileptic drug carbamazepine is taken up by plants. Kookana says there is a desperate need for more data on the effect of such pollution in low to middle-income countries. "Nearly 60 per cent of the generic drugs of the world are produced in China and India," says Kookana. "We are interlinked internationally," he adds. "We have a responsibility to help some of the developing countries to better understand the effects of these drugs in the environment." Australia not immune The researchers found Australia had a comparatively low risk of pollution from pharmaceuticals, but Kookana says there is still reason for concern. "Our population is ageing rapidly so our reliance on pharmaceuticals is increasing," he says. For this reason, the government funds a program to collect and dispose of unwanted and out-of-date medicines to stop pharmaceutical pollution at source. But Kookana also thinks regulatory agencies need to take Europe's lead and require manufacturers to consider the potential ecological impacts of their drugs. "I would like to see regulatory agencies in Australia give consideration to the ecological footprint of a given pharmaceutical active ingredient," says Kookana. Laurie Tenace Environmental Specialist Waste Reduction Section Florida Department of Environmental Protection 2600 Blair Stone Road, MS 4555 Tallahassee, FL 32399-2400 850.245.8759 Laurie.Tenace@dep.state.fl.us -------------- next part -------------- An HTML attachment was scrubbed... URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141219/7d2a7fe5/attachment-0001.html -------------- next part -------------- A non-text attachment was scrubbed... Name: image001.jpg Type: image/jpeg Size: 69911 bytes Desc: image001.jpg Url : http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141219/7d2a7fe5/image001-0001.jpg From jennifer.volkman at state.mn.us Fri Dec 19 10:23:18 2014 From: jennifer.volkman at state.mn.us (Volkman, Jennifer (MPCA)) Date: Fri Dec 19 10:26:04 2014 Subject: [Pharmwaste] RE: Drug pollution risk 'a global responsibility' In-Reply-To: <900d5ebd05db4774b310b578ddc66b02@CY1PR09MB0555.namprd09.prod.outlook.com> References: <900d5ebd05db4774b310b578ddc66b02@CY1PR09MB0555.namprd09.prod.outlook.com> Message-ID: How about it is the manufacturers responsibility not to contaminate the earth!! It isn't just the low labor rates, apparently there no regulations or no regulators to enforce them. Manufacturers should be treating effluent before it leaves the plant. :( ________________________________________ From: pharmwaste-bounces@lists.dep.state.fl.us [pharmwaste-bounces@lists.dep.state.fl.us] on behalf of Tenace, Laurie [Laurie.Tenace@dep.state.fl.us] Sent: Friday, December 19, 2014 7:03 AM To: 'pharmwaste@lists.dep.state.fl.us' Subject: [Pharmwaste] Drug pollution risk 'a global responsibility' http://www.abc.net.au/science/articles/2014/12/18/4145868.htm Drug pollution risk 'a global responsibility' Thursday, 18 December 2014 Anna Salleh ABC ________________________________ [pharmaceutical company] A growing percentage of the world's generic drugs is made in plants like this one in India (iStockphoto: Ajay Verma) Related Stories * Antibiotics flushed into waterways, Science Online, 17 Mar 2005 * Call for control of nano-silver use, Science Online, 20 Oct 2009 Pharmaceutical legacy Rich countries should help poorer countries deal with the risk posed by pharmaceutical contamination of the environment, says an Australian expert. Dr Rai Kookana, an environmental chemist with the CSIRO, made the comments following the release of a study published in a recent issue of Philosophical Transactions of the Royal Society B. The study is the first to compare the risk of pollution from drugs, including antibiotics, anti-inflammatories and antidepressants, in high-income and lower-income countries around the world. Kookana and colleagues gathered data on factors such as demographics, the manufacture and consumption of pharmaceuticals, and the quality of waste and wastewater systems to assess the potential risk from pharmaceuticals in 17 countries. They found that countries like China and India are at greater risk than higher-income countries, of groundwater, land and river contamination from the active ingredients of drugs. Drug manufacturing Kookana says poor waste and waste water systems are key factors contributing to pollution in lower-income countries. "Historically, when drugs are brought on to the market, the environment doesn't come into the picture at all. But obviously the drugs find their way into the environment through the waste stream," he says. Major "point sources" of contamination are drug manufacturing facilities, which are increasingly being moved to poorer countries, where labour costs are lower, he adds. "There is some evidence from China and India that effluents from drug manufacturing plants contain high concentrations of antibiotics and other drugs including antidepressants and NSAIDs (non-steroidal anti-inflammatory drugs)," says Kookana. "The rivers and lakes receiving these effluents have been found to be contaminated with these drugs." He says a 2007 Swedish study found drug concentrations in a river adjacent to one drug manufacturing area exceeded the therapeutic levels in humans. Drugged vultures Previous research has shown that some pharmaceuticals are known to persist in the environment and there is evidence they affect animals, says Kookana. For example, a 2004 paper in Nature blamed a crash in vulture numbers on the Indian subcontinent on pollution from the anti-inflammatory drug diclofenac. "There is also some evidence that antidepressants such as fluoxetine can cause behavioural problems in fish, water fleas and birds," he adds. And his own research has shown the mood stabiliser and anti-epileptic drug carbamazepine is taken up by plants. Kookana says there is a desperate need for more data on the effect of such pollution in low to middle-income countries. "Nearly 60 per cent of the generic drugs of the world are produced in China and India," says Kookana. "We are interlinked internationally," he adds. "We have a responsibility to help some of the developing countries to better understand the effects of these drugs in the environment." Australia not immune The researchers found Australia had a comparatively low risk of pollution from pharmaceuticals, but Kookana says there is still reason for concern. "Our population is ageing rapidly so our reliance on pharmaceuticals is increasing," he says. For this reason, the government funds a program to collect and dispose of unwanted and out-of-date medicines to stop pharmaceutical pollution at source. But Kookana also thinks regulatory agencies need to take Europe's lead and require manufacturers to consider the potential ecological impacts of their drugs. "I would like to see regulatory agencies in Australia give consideration to the ecological footprint of a given pharmaceutical active ingredient," says Kookana. Laurie Tenace Environmental Specialist Waste Reduction Section Florida Department of Environmental Protection 2600 Blair Stone Road, MS 4555 Tallahassee, FL 32399-2400 850.245.8759 Laurie.Tenace@dep.state.fl.us -------------- next part -------------- A non-text attachment was scrubbed... Name: image001.jpg Type: image/jpeg Size: 69911 bytes Desc: image001.jpg Url : http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141219/dbe3365e/image001-0001.jpg From GILLIAM at adeq.state.ar.us Fri Dec 19 11:33:33 2014 From: GILLIAM at adeq.state.ar.us (Gilliam, Allen) Date: Fri Dec 19 11:34:09 2014 Subject: [Pharmwaste] RE: Drug pollution risk 'a global responsibility' In-Reply-To: References: <900d5ebd05db4774b310b578ddc66b02@CY1PR09MB0555.namprd09.prod.outlook.com> Message-ID: Preaching to the preachers (or is that the choir?) Jennifer, P2 with its source reduction evidently has not yet been fully engrained in the mindset of the big Pharmas. They're blind to the fact they're disposing of some of their products/capital that could be better spent on P2 and better w.w. treatment as the last resort. Allen g -----Original Message----- From: pharmwaste-bounces@lists.dep.state.fl.us [mailto:pharmwaste-bounces@lists.dep.state.fl.us] On Behalf Of Volkman, Jennifer (MPCA) Sent: Friday, December 19, 2014 9:23 AM To: 'pharmwaste@lists.dep.state.fl.us' Subject: [Pharmwaste] RE: Drug pollution risk 'a global responsibility' How about it is the manufacturers responsibility not to contaminate the earth!! It isn't just the low labor rates, apparently there no regulations or no regulators to enforce them. Manufacturers should be treating effluent before it leaves the plant. :( ________________________________________ From: pharmwaste-bounces@lists.dep.state.fl.us [pharmwaste-bounces@lists.dep.state.fl.us] on behalf of Tenace, Laurie [Laurie.Tenace@dep.state.fl.us] Sent: Friday, December 19, 2014 7:03 AM To: 'pharmwaste@lists.dep.state.fl.us' Subject: [Pharmwaste] Drug pollution risk 'a global responsibility' http://www.abc.net.au/science/articles/2014/12/18/4145868.htm Drug pollution risk 'a global responsibility' Thursday, 18 December 2014 Anna Salleh ABC ________________________________ [pharmaceutical company] A growing percentage of the world's generic drugs is made in plants like this one in India (iStockphoto: Ajay Verma) Related Stories * Antibiotics flushed into waterways, Science Online, 17 Mar 2005 * Call for control of nano-silver use, Science Online, 20 Oct 2009 Pharmaceutical legacy Rich countries should help poorer countries deal with the risk posed by pharmaceutical contamination of the environment, says an Australian expert. Dr Rai Kookana, an environmental chemist with the CSIRO, made the comments following the release of a study published in a recent issue of Philosophical Transactions of the Royal Society B. The study is the first to compare the risk of pollution from drugs, including antibiotics, anti-inflammatories and antidepressants, in high-income and lower-income countries around the world. Kookana and colleagues gathered data on factors such as demographics, the manufacture and consumption of pharmaceuticals, and the quality of waste and wastewater systems to assess the potential risk from pharmaceuticals in 17 countries. They found that countries like China and India are at greater risk than higher-income countries, of groundwater, land and river contamination from the active ingredients of drugs. Drug manufacturing Kookana says poor waste and waste water systems are key factors contributing to pollution in lower-income countries. "Historically, when drugs are brought on to the market, the environment doesn't come into the picture at all. But obviously the drugs find their way into the environment through the waste stream," he says. Major "point sources" of contamination are drug manufacturing facilities, which are increasingly being moved to poorer countries, where labour costs are lower, he adds. "There is some evidence from China and India that effluents from drug manufacturing plants contain high concentrations of antibiotics and other drugs including antidepressants and NSAIDs (non-steroidal anti-inflammatory drugs)," says Kookana. "The rivers and lakes receiving these effluents have been found to be contaminated with these drugs." He says a 2007 Swedish study found drug concentrations in a river adjacent to one drug manufacturing area exceeded the therapeutic levels in humans. Drugged vultures Previous research has shown that some pharmaceuticals are known to persist in the environment and there is evidence they affect animals, says Kookana. For example, a 2004 paper in Nature blamed a crash in vulture numbers on the Indian subcontinent on pollution from the anti-inflammatory drug diclofenac. "There is also some evidence that antidepressants such as fluoxetine can cause behavioural problems in fish, water fleas and birds," he adds. And his own research has shown the mood stabiliser and anti-epileptic drug carbamazepine is taken up by plants. Kookana says there is a desperate need for more data on the effect of such pollution in low to middle-income countries. "Nearly 60 per cent of the generic drugs of the world are produced in China and India," says Kookana. "We are interlinked internationally," he adds. "We have a responsibility to help some of the developing countries to better understand the effects of these drugs in the environment." Australia not immune The researchers found Australia had a comparatively low risk of pollution from pharmaceuticals, but Kookana says there is still reason for concern. "Our population is ageing rapidly so our reliance on pharmaceuticals is increasing," he says. For this reason, the government funds a program to collect and dispose of unwanted and out-of-date medicines to stop pharmaceutical pollution at source. But Kookana also thinks regulatory agencies need to take Europe's lead and require manufacturers to consider the potential ecological impacts of their drugs. "I would like to see regulatory agencies in Australia give consideration to the ecological footprint of a given pharmaceutical active ingredient," says Kookana. Laurie Tenace Environmental Specialist Waste Reduction Section Florida Department of Environmental Protection 2600 Blair Stone Road, MS 4555 Tallahassee, FL 32399-2400 850.245.8759 Laurie.Tenace@dep.state.fl.us From Burke.Lucy at CalRecycle.ca.gov Fri Dec 19 12:22:39 2014 From: Burke.Lucy at CalRecycle.ca.gov (Lucy, Burke@CalRecycle) Date: Fri Dec 19 12:22:59 2014 Subject: [Pharmwaste] Interesting 'destruction' of controlled substances Message-ID: <84f20ceedabd46b4ba9bc9303e8d50e2@DR3MAIL02.itservices.network> WPD receives 'drop off box' for disposal of medicine, December 18, 2014 http://www.williamsondailynews.com/news/home_top-news/150936594/WPD-receives-drop-off-box-for-disposal-of-medicine "The drugs will be destroyed by transferring them to an Element MDS system. The system consists of a disposable bottle where the drugs will be transferred to and an MDS powder packet will be added along with water. The lid is then tightened on the bottle which will auto lock and cannot be removed. The bottle will be shaken to mix the contents and all medicine inside the bottle will dissolve. The bottle is then ready to be placed in a trash receptacle for safe disposal." According to the manufacturer's brochure apparently for "many people in medical, environmental, and regulatory groups," (http://elementmds.com/wp-content/themes/ABC-basic/images/2014%20EMDS%20WP.pdf) the benefits of Element(r) MDS include: "Can accommodate controlled substances unlike mail-in kits." Burke -------------- next part -------------- An HTML attachment was scrubbed... URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141219/4173fe5a/attachment.htm From EGottlieb at cityofithaca.org Fri Dec 19 13:48:49 2014 From: EGottlieb at cityofithaca.org (Ed Gottlieb) Date: Fri Dec 19 13:40:45 2014 Subject: [Pharmwaste] RE: Interesting 'destruction' of controlled substances In-Reply-To: <84f20ceedabd46b4ba9bc9303e8d50e2@DR3MAIL02.itservices.network> References: <84f20ceedabd46b4ba9bc9303e8d50e2@DR3MAIL02.itservices.network> Message-ID: <65AC0C9A3A6A474EAD8D56070FED66980F03FBBB@MAIL.cityofithaca.org> Burke, Thanks for sharing this story. I want to make two points, one about the news story and the other about the disposal product that is mentioned. The news story included a photo of the new box located outside the police station, with video monitoring. I have seen other stories showing new boxes installed outside of law enforcement buildings. The DEA was clear on this point: ? 1317.35 Collection by law enforcement. (3) Collection receptacles located inside law enforcement?s physical address. ? 1317.75 Collection receptacles. 1) Inside a collector?s registered location, inside law enforcement?s physical location, or at an authorized long-term care facility; Any thoughts about how information about the new DEA requirements can be communicated to law enforcement agencies? They are making an effort to be a part of this solution, how can we help them to get it right? Would an organization you have a connection to submit letters to the editor of law enforcement trade magazines? I'd be happy to help write the letter. Other ideas? Thanks! Selling the Element MDS as pharm waste disposal solution that, "Can accommodate controlled substances unlike mail-in kits" appears to me to false in two respects. First, mail-in kits may now used to collect controlled substances. Second, if "can accommodate" is a reference to their claim, "Renders the medication undesirable", it does not meet the DEA requirement for the medication to be "unrecoverable". They manufacturer states, possibly accurately, that with it you can " MEET ALL SMART RX GUIDELINES ADOPTED BY THE FDA AND EPA." As previous posts have discussed, these agencies have not updated their guidelines to be in harmony with the new DEA rule. Note the absence of the DEA in their claim. Ed Gottlieb Chair, Coalition for Safe Medication Disposal Industrial Pretreatment Coordinator Ithaca Area Wastewater Treatment Facility 525 3rd Street Ithaca, NY 14850 (607) 273-8381 fax: (607) 273-8433 ________________________________ From: pharmwaste-bounces@lists.dep.state.fl.us [pharmwaste-bounces@lists.dep.state.fl.us] on behalf of Lucy, Burke@CalRecycle [Burke.Lucy@CalRecycle.ca.gov] Sent: Friday, December 19, 2014 12:22 PM To: 'pharmwaste@lists.dep.state.fl.us' Subject: [Pharmwaste] Interesting 'destruction' of controlled substances WPD receives ?drop off box? for disposal of medicine, December 18, 2014 http://www.williamsondailynews.com/news/home_top-news/150936594/WPD-receives-drop-off-box-for-disposal-of-medicine ?The drugs will be destroyed by transferring them to an Element MDS system. The system consists of a disposable bottle where the drugs will be transferred to and an MDS powder packet will be added along with water. The lid is then tightened on the bottle which will auto lock and cannot be removed. The bottle will be shaken to mix the contents and all medicine inside the bottle will dissolve. The bottle is then ready to be placed in a trash receptacle for safe disposal.? According to the manufacturer?s brochure apparently for ?many people in medical, environmental, and regulatory groups,? (http://elementmds.com/wp-content/themes/ABC-basic/images/2014%20EMDS%20WP.pdf) the benefits of Element? MDS include: ?Can accommodate controlled substances unlike mail-in kits.? Burke -------------- next part -------------- An HTML attachment was scrubbed... URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141219/a3bedd9c/attachment.htm From csmith at pharmecology.com Fri Dec 19 13:58:16 2014 From: csmith at pharmecology.com (Smith, Charlotte) Date: Fri Dec 19 13:49:32 2014 Subject: [Pharmwaste] RE: Interesting 'destruction' of controlled substances In-Reply-To: <84f20ceedabd46b4ba9bc9303e8d50e2@DR3MAIL02.itservices.network> References: <84f20ceedabd46b4ba9bc9303e8d50e2@DR3MAIL02.itservices.network> Message-ID: <74A2611A6ED8F34EA5D2A854C03FF20F207A6FBD@ADCMBX001.wm.com> While law enforcement has the freedom to manage controlled substances as they see fit from a diversion perspective under DEA regulations, I'm not so sure they can dispose in a landfill without special permission through a waste acceptance manager. Hopefully they have already gone through that process locally. Best regards, Charlotte A. Smith, R. Ph., M.S. Senior Regulatory Advisor WMSS PharmEcology Services csmith@pharmecology.com 713-725-6363 From: pharmwaste-bounces@lists.dep.state.fl.us [mailto:pharmwaste-bounces@lists.dep.state.fl.us] On Behalf Of Lucy, Burke@CalRecycle Sent: Friday, December 19, 2014 11:23 AM To: 'pharmwaste@lists.dep.state.fl.us' Subject: [Pharmwaste] Interesting 'destruction' of controlled substances WPD receives 'drop off box' for disposal of medicine, December 18, 2014 http://www.williamsondailynews.com/news/home_top-news/150936594/WPD-receives-drop-off-box-for-disposal-of-medicine "The drugs will be destroyed by transferring them to an Element MDS system. The system consists of a disposable bottle where the drugs will be transferred to and an MDS powder packet will be added along with water. The lid is then tightened on the bottle which will auto lock and cannot be removed. The bottle will be shaken to mix the contents and all medicine inside the bottle will dissolve. The bottle is then ready to be placed in a trash receptacle for safe disposal." According to the manufacturer's brochure apparently for "many people in medical, environmental, and regulatory groups," (http://elementmds.com/wp-content/themes/ABC-basic/images/2014%20EMDS%20WP.pdf) the benefits of Element(r) MDS include: "Can accommodate controlled substances unlike mail-in kits." Burke ---------------------------------------------------------------------- Recycling is a good thing. Please recycle any printed emails. -------------- next part -------------- An HTML attachment was scrubbed... URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141219/0c3b536b/attachment.htm From Burke.Lucy at CalRecycle.ca.gov Fri Dec 19 14:40:23 2014 From: Burke.Lucy at CalRecycle.ca.gov (Lucy, Burke@CalRecycle) Date: Fri Dec 19 14:44:15 2014 Subject: [Pharmwaste] RE: Interesting 'destruction' of controlled substances In-Reply-To: <74A2611A6ED8F34EA5D2A854C03FF20F207A6FBD@ADCMBX001.wm.com> References: <84f20ceedabd46b4ba9bc9303e8d50e2@DR3MAIL02.itservices.network> <74A2611A6ED8F34EA5D2A854C03FF20F207A6FBD@ADCMBX001.wm.com> Message-ID: <656a9f395e2146998418b552c1a20fae@DR3MAIL02.itservices.network> I agree Charlotte, Page 53531 of DEA Regs' Q&A section referencing storage standards say, "The language used in the text of the rule, 'should,' is suggestive. Law enforcement are encouraged to follow the guidance in 21 CFR 1317.35; however, they are not required to do so." Likewise, for the 'inside' verbiage, they say law enforcement 'may' use that method. ? 1317.35 Collection by law enforcement. (a) Federal, State, tribal, or local law enforcement may collect controlled substances from ultimate users and persons lawfully entitled to dispose of an ultimate user decedent's property using the following collection methods: ... (3) Collection receptacles located inside law enforcement's physical address. ? 1317.35 (d) refers to disposition and is also suggestive in using 'should' by saying: "Any controlled substances collected by law enforcement through a ...collection receptacle should be transferred to a destruction location in a manner that prevents the diversion of controlled substances and is consistent with that agency's standard procedures for transferring illicit controlled substances." It seems the key question is whether anyone other than ultimate users can transfer controlled substances to solid waste people even if it's embedded in a gel or dissolved and might still be 'retrievable.' Ed, I'm not sure I have any better contact than you would even if I had the bandwidth to help out beyond sharing this info. Burke From: Smith, Charlotte [mailto:csmith@pharmecology.com] Sent: Friday, December 19, 2014 10:58 AM To: Lucy, Burke@CalRecycle; 'pharmwaste@lists.dep.state.fl.us' Subject: RE: Interesting 'destruction' of controlled substances While law enforcement has the freedom to manage controlled substances as they see fit from a diversion perspective under DEA regulations, I'm not so sure they can dispose in a landfill without special permission through a waste acceptance manager. Hopefully they have already gone through that process locally. Best regards, Charlotte A. Smith, R. Ph., M.S. Senior Regulatory Advisor WMSS PharmEcology Services csmith@pharmecology.com 713-725-6363 From: pharmwaste-bounces@lists.dep.state.fl.us [mailto:pharmwaste-bounces@lists.dep.state.fl.us] On Behalf Of Lucy, Burke@CalRecycle Sent: Friday, December 19, 2014 11:23 AM To: 'pharmwaste@lists.dep.state.fl.us' Subject: [Pharmwaste] Interesting 'destruction' of controlled substances WPD receives 'drop off box' for disposal of medicine, December 18, 2014 http://www.williamsondailynews.com/news/home_top-news/150936594/WPD-receives-drop-off-box-for-disposal-of-medicine "The drugs will be destroyed by transferring them to an Element MDS system. The system consists of a disposable bottle where the drugs will be transferred to and an MDS powder packet will be added along with water. The lid is then tightened on the bottle which will auto lock and cannot be removed. The bottle will be shaken to mix the contents and all medicine inside the bottle will dissolve. The bottle is then ready to be placed in a trash receptacle for safe disposal." According to the manufacturer's brochure apparently for "many people in medical, environmental, and regulatory groups," (http://elementmds.com/wp-content/themes/ABC-basic/images/2014%20EMDS%20WP.pdf) the benefits of Element? MDS include: "Can accommodate controlled substances unlike mail-in kits." Burke ________________________________ Recycling is a good thing. Please recycle any printed emails. -------------- next part -------------- An HTML attachment was scrubbed... URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141219/be3930d7/attachment.htm From Jeanie.Jaramillo at ttuhsc.edu Sat Dec 20 13:32:51 2014 From: Jeanie.Jaramillo at ttuhsc.edu (Jaramillo, Jeanie) Date: Sat Dec 20 13:33:24 2014 Subject: [Pharmwaste] Interesting 'destruction' of controlled substances In-Reply-To: <84f20ceedabd46b4ba9bc9303e8d50e2@DR3MAIL02.itservices.network> References: <84f20ceedabd46b4ba9bc9303e8d50e2@DR3MAIL02.itservices.network> Message-ID: <89794C5282FE3149A068A7A5111C0DB06C6B5862@lubmb01.ttuhsc.edu> I would guess this would be quite a cumbersome process that is labor intensive and requires extensive handling of the medications. They won't be able to leave liquids in their containers when they transfer them to the "disposable bottle", which means someone would have to be pouring them into the disposal containers. Same thing with pills; assuming that they aren't having the public pour pills loosely into the collection receptacle. Looks like this is in West Virginia...? Anyone there interested perhaps offering them some help? Maybe a call commending them on their program and an offer for alternative disposal if they find this method isn't working. Or maybe a partnership... Certainly, don't want to offend them when their working to be part of the solution. Jeanie Jaramillo, PharmD Managing Director, Texas Panhandle Poison Center Asst. Professor, Texas Tech UHSC School of Pharmacy 1300 S. Coulter St., Suite 105 Amarillo, TX 79106 (office): (806)414-9299 (mobile): (806)376-0039 ________________________________ From: Lucy, Burke@CalRecycle [Burke.Lucy@CalRecycle.ca.gov] Sent: Friday, December 19, 2014 11:22 AM To: 'pharmwaste@lists.dep.state.fl.us' Subject: [Pharmwaste] Interesting 'destruction' of controlled substances WPD receives ?drop off box? for disposal of medicine, December 18, 2014 http://www.williamsondailynews.com/news/home_top-news/150936594/WPD-receives-drop-off-box-for-disposal-of-medicine ?The drugs will be destroyed by transferring them to an Element MDS system. The system consists of a disposable bottle where the drugs will be transferred to and an MDS powder packet will be added along with water. The lid is then tightened on the bottle which will auto lock and cannot be removed. The bottle will be shaken to mix the contents and all medicine inside the bottle will dissolve. The bottle is then ready to be placed in a trash receptacle for safe disposal.? According to the manufacturer?s brochure apparently for ?many people in medical, environmental, and regulatory groups,? (http://elementmds.com/wp-content/themes/ABC-basic/images/2014%20EMDS%20WP.pdf) the benefits of Element? MDS include: ?Can accommodate controlled substances unlike mail-in kits.? Burke -------------- next part -------------- An HTML attachment was scrubbed... URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141220/ba051873/attachment.html From EGottlieb at cityofithaca.org Mon Dec 22 14:10:38 2014 From: EGottlieb at cityofithaca.org (Ed Gottlieb) Date: Mon Dec 22 14:12:16 2014 Subject: [Pharmwaste] Interesting 'destruction' of controlled substances In-Reply-To: <89794C5282FE3149A068A7A5111C0DB06C6B5862@lubmb01.ttuhsc.edu> References: <84f20ceedabd46b4ba9bc9303e8d50e2@DR3MAIL02.itservices.network>, <89794C5282FE3149A068A7A5111C0DB06C6B5862@lubmb01.ttuhsc.edu> Message-ID: <65AC0C9A3A6A474EAD8D56070FED66980F03FC50@MAIL.cityofithaca.org> I agree that the transfer from a collection box to a "disposal bottle" would be labor intensive. Did the manufactures website even mention blister packs of sealed pills? I can't image anyone sitting down to pop them out, not when they can show up by the bag-full. It is correct that the word "may", in ? 1317.35 (a), gives permission for law enforcement to not collect controlled substances. If they decide to, they "may" use one or more of the three collection methods are listed. Methods (1) & (2) are to be done in accordance with ? 1317.65 & ? 1317.70 respectively. The paragraphs for take back events (? 1317.65) are full of the word "should". The details for mail back programs (? 1317.70) uses the word "shall", which I read as "must". Method (3), "Collection receptacles located inside law enforcement?s physical address." does not use the word "should". My conclusion is that if law enforcement uses collection boxes they must be placed inside their building and that outside locations would not be permitted. The word "should" again appears in many paragraphs following this, in reference to: record keeping, storage, and disposal of the collected medications. Deborah, thanks for the suggestion for what state associations we can contact to help ensure that law enforcement in our state understands the new rule. Ed Gottlieb Chair, Coalition for Safe Medication Disposal Industrial Pretreatment Coordinator Ithaca Area Wastewater Treatment Facility 525 3rd Street Ithaca, NY 14850 (607) 273-8381 fax: (607) 273-8433 ________________________________ From: pharmwaste-bounces@lists.dep.state.fl.us [pharmwaste-bounces@lists.dep.state.fl.us] on behalf of Jaramillo, Jeanie [Jeanie.Jaramillo@ttuhsc.edu] Sent: Saturday, December 20, 2014 1:32 PM To: pharmwaste@lists.dep.state.fl.us Subject: RE: [Pharmwaste] Interesting 'destruction' of controlled substances I would guess this would be quite a cumbersome process that is labor intensive and requires extensive handling of the medications. They won't be able to leave liquids in their containers when they transfer them to the "disposable bottle", which means someone would have to be pouring them into the disposal containers. Same thing with pills; assuming that they aren't having the public pour pills loosely into the collection receptacle. Looks like this is in West Virginia...? Anyone there interested perhaps offering them some help? Maybe a call commending them on their program and an offer for alternative disposal if they find this method isn't working. Or maybe a partnership... Certainly, don't want to offend them when their working to be part of the solution. Jeanie Jaramillo, PharmD Managing Director, Texas Panhandle Poison Center Asst. Professor, Texas Tech UHSC School of Pharmacy 1300 S. Coulter St., Suite 105 Amarillo, TX 79106 (office): (806)414-9299 (mobile): (806)376-0039 ________________________________ From: Lucy, Burke@CalRecycle [Burke.Lucy@CalRecycle.ca.gov] Sent: Friday, December 19, 2014 11:22 AM To: 'pharmwaste@lists.dep.state.fl.us' Subject: [Pharmwaste] Interesting 'destruction' of controlled substances WPD receives ?drop off box? for disposal of medicine, December 18, 2014 http://www.williamsondailynews.com/news/home_top-news/150936594/WPD-receives-drop-off-box-for-disposal-of-medicine ?The drugs will be destroyed by transferring them to an Element MDS system. The system consists of a disposable bottle where the drugs will be transferred to and an MDS powder packet will be added along with water. The lid is then tightened on the bottle which will auto lock and cannot be removed. The bottle will be shaken to mix the contents and all medicine inside the bottle will dissolve. The bottle is then ready to be placed in a trash receptacle for safe disposal.? According to the manufacturer?s brochure apparently for ?many people in medical, environmental, and regulatory groups,? (http://elementmds.com/wp-content/themes/ABC-basic/images/2014%20EMDS%20WP.pdf) the benefits of Element? MDS include: ?Can accommodate controlled substances unlike mail-in kits.? Burke -------------- next part -------------- An HTML attachment was scrubbed... URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141222/22c672b3/attachment.html From Burke.Lucy at CalRecycle.ca.gov Mon Dec 22 16:19:30 2014 From: Burke.Lucy at CalRecycle.ca.gov (Lucy, Burke@CalRecycle) Date: Mon Dec 22 16:19:48 2014 Subject: [Pharmwaste] Interesting 'destruction' of controlled substances In-Reply-To: <65AC0C9A3A6A474EAD8D56070FED66980F03FC50@MAIL.cityofithaca.org> References: <84f20ceedabd46b4ba9bc9303e8d50e2@DR3MAIL02.itservices.network>, <89794C5282FE3149A068A7A5111C0DB06C6B5862@lubmb01.ttuhsc.edu> <65AC0C9A3A6A474EAD8D56070FED66980F03FC50@MAIL.cityofithaca.org> Message-ID: <4ffe0908488f45af950841ef4617f315@DR3MAIL02.itservices.network> I think you're right Ed. ?1317.75(d) also says: Collection receptacles shall be securely placed and maintained: (1) Inside a collector's registered location, inside law enforcement's physical location, or at an authorized long-term care facility; Apparently, it's not enough to do a once-through reading of the DEA's regs. I do appreciate your willingness to get the word out to those folks who may be missing it. Happy Holidays! Burke From: pharmwaste-bounces@lists.dep.state.fl.us [mailto:pharmwaste-bounces@lists.dep.state.fl.us] On Behalf Of Ed Gottlieb Sent: Monday, December 22, 2014 11:11 AM To: Jaramillo, Jeanie; pharmwaste@lists.dep.state.fl.us Subject: RE: [Pharmwaste] Interesting 'destruction' of controlled substances I agree that the transfer from a collection box to a "disposal bottle" would be labor intensive. Did the manufactures website even mention blister packs of sealed pills? I can't image anyone sitting down to pop them out, not when they can show up by the bag-full. It is correct that the word "may", in ? 1317.35 (a), gives permission for law enforcement to not collect controlled substances. If they decide to, they "may" use one or more of the three collection methods are listed. Methods (1) & (2) are to be done in accordance with ? 1317.65 & ? 1317.70 respectively. The paragraphs for take back events (? 1317.65) are full of the word "should". The details for mail back programs (? 1317.70) uses the word "shall", which I read as "must". Method (3), "Collection receptacles located inside law enforcement's physical address." does not use the word "should". My conclusion is that if law enforcement uses collection boxes they must be placed inside their building and that outside locations would not be permitted. The word "should" again appears in many paragraphs following this, in reference to: record keeping, storage, and disposal of the collected medications. Deborah, thanks for the suggestion for what state associations we can contact to help ensure that law enforcement in our state understands the new rule. Ed Gottlieb Chair, Coalition for Safe Medication Disposal Industrial Pretreatment Coordinator Ithaca Area Wastewater Treatment Facility 525 3rd Street Ithaca, NY 14850 (607) 273-8381 fax: (607) 273-8433 ________________________________ From: pharmwaste-bounces@lists.dep.state.fl.us [pharmwaste-bounces@lists.dep.state.fl.us] on behalf of Jaramillo, Jeanie [Jeanie.Jaramillo@ttuhsc.edu] Sent: Saturday, December 20, 2014 1:32 PM To: pharmwaste@lists.dep.state.fl.us Subject: RE: [Pharmwaste] Interesting 'destruction' of controlled substances I would guess this would be quite a cumbersome process that is labor intensive and requires extensive handling of the medications. They won't be able to leave liquids in their containers when they transfer them to the "disposable bottle", which means someone would have to be pouring them into the disposal containers. Same thing with pills; assuming that they aren't having the public pour pills loosely into the collection receptacle. Looks like this is in West Virginia...? Anyone there interested perhaps offering them some help? Maybe a call commending them on their program and an offer for alternative disposal if they find this method isn't working. Or maybe a partnership... Certainly, don't want to offend them when their working to be part of the solution. Jeanie Jaramillo, PharmD Managing Director, Texas Panhandle Poison Center Asst. Professor, Texas Tech UHSC School of Pharmacy 1300 S. Coulter St., Suite 105 Amarillo, TX 79106 (office): (806)414-9299 (mobile): (806)376-0039 ________________________________ From: Lucy, Burke@CalRecycle [Burke.Lucy@CalRecycle.ca.gov] Sent: Friday, December 19, 2014 11:22 AM To: 'pharmwaste@lists.dep.state.fl.us' Subject: [Pharmwaste] Interesting 'destruction' of controlled substances WPD receives 'drop off box' for disposal of medicine, December 18, 2014 http://www.williamsondailynews.com/news/home_top-news/150936594/WPD-receives-drop-off-box-for-disposal-of-medicine "The drugs will be destroyed by transferring them to an Element MDS system. The system consists of a disposable bottle where the drugs will be transferred to and an MDS powder packet will be added along with water. The lid is then tightened on the bottle which will auto lock and cannot be removed. The bottle will be shaken to mix the contents and all medicine inside the bottle will dissolve. The bottle is then ready to be placed in a trash receptacle for safe disposal." According to the manufacturer's brochure apparently for "many people in medical, environmental, and regulatory groups," (http://elementmds.com/wp-content/themes/ABC-basic/images/2014%20EMDS%20WP.pdf) the benefits of Element? MDS include: "Can accommodate controlled substances unlike mail-in kits." Burke -------------- next part -------------- An HTML attachment was scrubbed... URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141222/318e908a/attachment.htm From EGottlieb at cityofithaca.org Mon Dec 29 13:42:29 2014 From: EGottlieb at cityofithaca.org (Ed Gottlieb) Date: Mon Dec 29 13:42:43 2014 Subject: [Pharmwaste] Retiring Sheriff most proud of drug take-back program Message-ID: <65AC0C9A3A6A474EAD8D56070FED66980F03FD4B@MAIL.cityofithaca.org> Of all the good work Sheriff DuVall did over more than thirty years in office (Russellville, AR.), he is most proud of the drug take-back program that he helped begin in cooperation with the town mayor, City Corp., the Lions Club and the American Legion. "I got very excited about it because as an investigator, I saw a lot of young people get their hands on prescription drugs," DuVall said. Read more: The Courier - Your Messenger for the River Valley - DuVall retires after more than 30 years Ed Gottlieb Chair, Coalition for Safe Medication Disposal Industrial Pretreatment Coordinator Ithaca Area Wastewater Treatment Facility 525 3rd Street Ithaca, NY 14850 (607) 273-8381 fax: (607) 273-8433 -------------- next part -------------- An HTML attachment was scrubbed... URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141229/a6e4a826/attachment.htm From GILLIAM at adeq.state.ar.us Mon Dec 29 14:25:32 2014 From: GILLIAM at adeq.state.ar.us (Gilliam, Allen) Date: Mon Dec 29 14:25:41 2014 Subject: [Pharmwaste] RE: Retiring Sheriff most proud of drug take-back program In-Reply-To: <65AC0C9A3A6A474EAD8D56070FED66980F03FD4B@MAIL.cityofithaca.org> References: <65AC0C9A3A6A474EAD8D56070FED66980F03FD4B@MAIL.cityofithaca.org> Message-ID: Thanks Ed, Highest per capita permanent drop boxes in the nation 'tis the great State of Arkansas. See http://www.artakeback.org/ "collection sites" to see over 100 of them saturating the State. Some forward thinking Cities are now placing in their Pretreatment Ordinances a prohibition against the disposal of any pharmaceuticals into their sewage collection system (hardly enforceable, but at least it's "on the books"). Hope everyone had a great Christmas! Allen g From: pharmwaste-bounces@lists.dep.state.fl.us [mailto:pharmwaste-bounces@lists.dep.state.fl.us] On Behalf Of Ed Gottlieb Sent: Monday, December 29, 2014 12:42 PM To: pharmwaste@lists.dep.state.fl.us Subject: [Pharmwaste] Retiring Sheriff most proud of drug take-back program Of all the good work Sheriff DuVall did over more than thirty years in office (Russellville, AR.), he is most proud of the drug take-back program that he helped begin in cooperation with the town mayor, City Corp., the Lions Club and the American Legion. "I got very excited about it because as an investigator, I saw a lot of young people get their hands on prescription drugs," DuVall said. Read more: The Courier - Your Messenger for the River Valley - DuVall retires after more than 30 years Ed Gottlieb Chair, Coalition for Safe Medication Disposal Industrial Pretreatment Coordinator Ithaca Area Wastewater Treatment Facility 525 3rd Street Ithaca, NY 14850 (607) 273-8381 fax: (607) 273-8433 -------------- next part -------------- An HTML attachment was scrubbed... URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20141229/795af6b4/attachment.htm