Two California Men Indicted for Selling Endangered Black Rhinoceros Horns
U.S. Fish & Wildlife / http://www.justice.gov/opa/pr/2014/April/14-enrd-336.html
Edward N. Levine, 63, of Mill Valley, Calif., and Lumsden W. Quan, 46, of San Francisco, were indicted by a federal grand jury in Las Vegas today for the illegal sale of two horns from an endangered black rhinoceros, announced Robert G. Dreher, Acting Assistant Attorney General for the Justice Department’s Environment and Natural Resources Division, and Daniel G. Bogden, U.S. Attorney for the District of Nevada. The indictment is a result of “Operation Crash,” a nationwide effort led by the U.S. Fish & Wildlife Service (FWS) and the Justice Department to investigate and prosecute those involved in the black market trade of endangered rhinoceros horns.
The indictment charges Levine and Quan each with one count of conspiracy to violate the Lacey Act and the Endangered Species Act and one count of violating the Lacey Act. The Lacey Act prohibits the sale of wildlife that was transported in violation of law. The Endangered Species Act prohibits the interstate transportation of endangered species for a commercial purpose and the interstate sale of an endangered species.
According to the indictment, over the course of approximately two months, Quan and Levine negotiated the sale of two black rhinoceros horns by e-mail and telephone, ultimately communicating with a law enforcement officer acting in an undercover capacity. The indictment further alleges that Quan and Levine offered to sell the two black rhinoceros horns for $55,000 and agreed to meet the buyer in Las Vegas. On March 19, 2014, after directing another person to drive with the horns from California to Las Vegas, Quan and Levine flew from California to Las Vegas, to make the sale. Quan met the law enforcement officer acting in an undercover capacity in a Las Vegas hotel room, where Quan sold two black rhinoceros horns for $55,000. Both men were arrested later that day.
Rhinoceros are herbivores of prehistoric origin and one of the largest remaining mega-fauna on earth. They have no known predators other than humans. All species of rhinoceros are protected under U.S. and international law and the black rhinoceros is endangered. Since 1976, trade in rhinoceros horn has been regulated under the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), a treaty signed by 180 countries around the world to protect fish, wildlife and plants that are or may become imperiled. Nevertheless, trafficking in rhinoceros horn has skyrocketed in recent years due to the demand for horn for ornamental carvings, good luck charms or alleged medicinal purposes. As a result of this demand, rhino populations have declined by more than 90 percent since 1970. South Africa, for example, has witnessed a rapid escalation in poaching of live rhinos, rising from 13 in 2007 to more than 1,000 in 2013.
The investigation is being conducted by the U.S. Fish and Wildlife Service’s Office of Law Enforcement. Officers from the National Park Service, U.S. Forest Service, and Nevada Division of Wildlife assisted with the arrests on March 19. The case is being prosecuted by Trial Attorney Todd S. Mikolop of the U.S. Justice Department’s Environmental Crimes Section of the Environment and Natural Resources Division and Assistant U.S. Attorney Kate Newman of the U.S. Attorney’s Office for the District of Nevada.
New Partnerships Advance Import Safety, Border Management
U.S. Customs & Border Protection / http://www.cbp.gov/newsroom/national-media-release/2014-04-01-000000/new-partnerships-advance-import-safety-border
WASHINGTON— U.S. Customs and Border Protection today announced the addition of the U.S. Food and Drug Administration (FDA), U.S. Fish and Wildlife Service (FWS) and National Marine Fisheries Service (NMFS) to the Commercial Targeting and Analysis Center (CTAC) in Washington, D.C. FDA, FWS and NMFS are partnering with U.S. Customs and Border Protection (CBP), and seven other participating federal agencies, to enhance targeting efforts on commercial imports posing a threat to the health and safety of the American public or other border management goals such as conservation of species. The agreement was finalized on March 15.
“Working side-by-side fosters a collaborative environment that is conducive to increased information sharing and enhanced relationships between key agency personnel,” said Commissioner R. Gil Kerlikowske. “The interagency collaboration taking place at CTAC exemplifies how working together as one U.S. Government at the Border serves to protect the American public.”
“Responding to the very real challenges of globalization as supply chains become more complex is a top priority for the FDA,” said FDA Commissioner Margaret A. Hamburg, M.D. “Partnering with U.S. Customs and Border Protection is an important mechanism that helps to identify shipments of food and medical products at our border that may pose a threat to the health of the American public. It also provides the opportunity to collaborate with other federal agencies in a novel information-sharing environment to ensure consumers that the products they use are safe, effective and of the highest quality.”
Bruce Buckson, Director of NOAA’s Office of Law Enforcement, noted that he “is looking forward to working hand-in-hand with CTAC and these other federal agencies. The expertise and resources offered through this group will enhance our enforcement capabilities and increase compliance with current NMFS regulations resulting in a level playing field for honest, hardworking fishermen."
“Broadening the scope of CTAC to encompass illegal wildlife trade and other management issues helps support the Nation’s high-priority fight against wildlife trafficking,” said FWS Director Dan Ashe. “Participating in the CTAC will give our law enforcement officers access to new intelligence and increased opportunities to partner with Customs and other Federal counterparts in keeping our borders closed to illegal products of all types.”
The addition of FDA, FWS and NMFS greatly augments CTAC’s level of expertise in high-risk food, drug and wildlife imports and brings the total number of agencies participating at the center to 11. At the CTAC, the 11 agencies are physically co-located to leverage their collective resources, expertise and authorities in the development of innovative targeting procedures. All partner agencies are also granted access to critical import data which allows for quicker and more informed decision-making.
Office of Textile and Apparel (OTEXA) - Announcements
International Trade Administration / http://otexa.ita.doc.gov/
04/02/2014 – The Federal Trade Commission (FTC) held a Roundtable on Proposed Changes to U.S. Care Labeling Rule for Clothing on Friday, March 28, 2014. The FTC will be accepting comments on the agenda topics and the issues discussed by the panelists at the roundtable until April 11, 2014.
04/01/2014 – The Industry Trade Advisory Center recently published a Federal Register notice announcing the re-chartering of the Industry Trade Advisory Committees (ITACs) and requesting nominations to fill vacancies on the ITACs. If you are interested in becoming an advisor to ITAC 13, Textiles and Clothing, and you represent the textile, apparel, footwear and/or travel goods industries, please review the FR notice for membership eligibility and criteria
Federal Agencies Directed to Take Action in Response to Iceland’s International Trade in Whale Meat and Products
U.S. Fish & Wildlife Service / http://www.fws.gov/news/ShowNews.cfm?ID=22C39AF0-B502-B836-BB4C04C5ECBD35A2
The President has notified Congress of actions he directed federal departments and agencies to take to encourage Iceland to cease international trade in whale meat and products. The President’s instructions come in response to a certification issued by Secretary of the Interior Sally Jewell that Iceland’s international trade in whale meat and products is diminishing the effectiveness of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES).
“The Icelandic government continues to increase its fin whaling quotas despite international pressure to cease its commercial hunting operations,” said Secretary Jewell. “The President’s actions today highlight our continued concern about and staunch opposition to Icelandic commercial fin whaling and the export of endangered fin whale meat.”
Secretary Jewell’s certification, as required by the Pelly Amendment to the Fishermen’s Protective Act, followed on from a similar certification by then-Secretary of Commerce Locke in July 2011, in which he stated that commercial whaling by Icelandic nationals diminished the effectiveness of the International Whaling Commission (IWC) conservation program. The IWC adopted a commercial whaling moratorium in 1982.
In the letter notifying Congress of his actions, the President said: “Just as the United States made the transition from a commercial whaling nation to a whale watching nation, we must enhance our engagement to facilitate this change by Iceland.” His directives reaffirm those made pursuant to the 2011 certification and include several additional actions including, among others, encouraging Iceland to promote alternative non-lethal uses of whales in Iceland, such as whale watching; working with other international actors on additional measures to reduce Iceland’s fin whale trade and enhance the effectiveness of CITES; and re-examining bilateral cooperation projects with Iceland in light of its whaling policies. A detailed list of the actions directed by President Obama can be found here: http://www.whitehouse.gov/the-press-office/2014/04/01/message-congress-iceland-and-fisherman-s-protective-act.
Iceland resumed commercial whaling in 2006 and since then has exported whale meat and products despite a ban on international commercial trade. Unlike Japan, Iceland does not consider itself to be bound by the IWC’s moratorium on commercial whaling. In December 2013, Iceland issued a fin whale quota of 154 fin whales per year for the years 2014-2019.
From 2008 to 2012, trade reports show that more than 1.6 million kilograms of fin whale meat and products were exported from Iceland to Japan. Fin whales are listed in Appendix I of CITES, which prohibits trade for primarily commercial purposes.
TC Testifies on Data Security Before Senate Homeland Security and Governmental Affairs Committee
Federal Trade Commission / http://www.ftc.gov/news-events/press-releases/2014/04/ftc-testifies-data-security-senate-homeland-security-governmental
Commission Renews Call for Data Security Legislation
In testimony before Congress today, the Federal Trade Commission provided an update on its efforts to protect consumers’ privacy in the face of growing data breaches and renewed its call for data security legislation.
Testifying on behalf of the Commission before the Senate Committee on Homeland Security and Governmental Affairs, Chairwoman Edith Ramirez told lawmakers that the Commission believed that as more data breaches are revealed, the risk to consumers and businesses becomes clear.
“Consumers’ data is at risk,” the testimony states. “Recent publicly announced data breaches remind us that hackers and others seek to exploit vulnerabilities, obtain unauthorized access to consumers’ sensitive information, and potentially misuse it in ways that can cause serious harm to consumers as well as businesses.”
The testimony highlights the Commission’s wide-ranging efforts in the data security arena, including its enforcement of the FTC Act as well as specific statutes such as the Fair Credit Reporting Act, Children’s Online Privacy Protection Act, and the Gramm-Leach-Bliley Act to encourage companies to make data security a priority. The Commission has settled more than 50 such cases alleging that companies took inadequate measures to protect consumer data. The testimony calls attention to recent settlements with Fandango and Credit Karma as part of the Commission’s effort to encourage companies to adopt security in the design of their products.
In addition, the testimony outlines the Commission’s policy initiatives related to data security issues, including workshops, seminars and reports on a wide variety of topics that affect the collection, use and security of consumers’ personal information. The testimony also notes the Commission’s ongoing efforts to educate consumers and provide guidance to businesses about issues related to data security.
In calling for legislation, the Commission’s testimony recommends that Congress strengthen its existing authority governing data security tools, and that it require companies in appropriate circumstances to notify consumers affected by a data breach. Specifically, the testimony calls for authority to seek civil penalties to help deter unlawful conduct, rulemaking authority under the Administrative Procedures Act, and jurisdiction over non-profit entities, which are not currently subject to FTC oversight.
The Commission vote approving the testimony and its inclusion in the formal record was 4-0.
The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s website provides free information on a variety of consumer topics. Like the FTC on Facebook, follow us on Twitter, and subscribe to press releases for the latest FTC news and resources.
FDA Commissioner Margaret A. Hamburg Statement on Prescription Opioid Abuse
U.S. Food & Drug Administration / http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391590.htm
For more than a decade, the U.S. Food and Drug Administration has been working to address the important public health problems associated with the misuse, abuse, addiction and overdose of opioid analgesics, while at the same time working to ensure continued access to effective and appropriate medications for millions of Americans currently suffering from pain. I firmly believe that these goals are compatible, and that actions to address one should not be at the expense of the other.
Tragically, the most recent data shows that more than 16,000 lives are lost each year due to opioid-related overdoses. In fact, drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. We know that the illegal diversion, misuse, and abuse of prescription opioids are often fueled by inappropriate prescribing, improper disposal of unused medications, and the illegal activity of a small number of health care providers. This highlights the important role that education of prescribers and patients can play in addressing this epidemic. The FDA has taken steps to address this but more work remains to be done.
Combatting the serious public health problem of misuse, abuse, addiction and overdose from opioid analgesics is a high priority. Since 2001 the FDA has taken a number of actions designed to help address prescription opioid abuse and to encourage the development of new drug treatments for pain. These actions include:
- Revising the labeling for opioid medications to foster their safe and appropriate use, including recent changes to the indications and safety warnings of extended-release and long-acting opioids.
- Requiring that manufacturers conduct studies of the safety of long-term use of prescription opioids.
- Improving appropriate prescribing by physicians and use by patients through educational materials required as a part of a risk mitigation strategy for extended-release and long-acting opioids.
- Using the agency’s expedited review programs to advance development of new non-opioid medications to treat pain with the goal of bringing new non- or less-abusable products to market.
- Working with other federal agencies and scientists to advance our understanding of the mechanisms for pain and how to treat it, including the search for new non-opioid medications for pain.
- Recommending that hydrocodone-containing combination products have additional restrictions on their use by rescheduling them from Schedule III to Schedule II.
- Strengthening surveillance efforts to actively monitor the changing nature of prescription opioid abuse and to identify emerging issues.
- And, importantly, encouraging the development of medications to treat opioid abuse, such as buprenorphine for use in medication-assisted treatment, and to reverse opioid overdoses, such as naloxone.
Today’s FDA approval of Evzio (naloxone autoinjector) provides an important new tool in our arsenal to more effectively combat the devastating effects of opioid overdose, which is one part of our comprehensive work to support opioid safety. Reflecting the FDA’s commitment to encouraging important new therapies, the FDA’s review of Evzio was granted priority status, and the application was reviewed by the FDA in just 15 weeks.
This product is the first auto-injector designed to rapidly reverse the overdose of either prescription or illicit opioids. While the larger goal is to reduce the need for products like these by preventing opioid addiction and abuse, they are extremely important innovations that will help to save lives.
The FDA will continue to work to reduce the risks of abuse and misuse of prescription opioids, but we cannot solve this complex problem alone. A comprehensive and coordinated approach is needed; one that includes the White House Office of National Drug Control Policy, the Drug Enforcement Administration and many of our sister agencies within the Department of Health and Human Services, as well as state and local governments, public health experts, health care professionals, addiction experts, researchers, industry, and patient organizations.
I am confident that this can be accomplished, but we will all need to work together to invest in strategies and responsible approaches that deter or mitigate the effects of abuse while preserving access to pain medicines for the patients that need them the most.
FDA Approves First Sublingual Allergen Extract for the Treatment of Certain Grass Pollen Allergies
U.S. Food & Drug Administration / http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391458.htm
The U.S. Food and Drug Administration recently approved Oralair to treat allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) that is induced by certain grass pollens in people ages 10 through 65 years. Oralair is the first sublingual (under the tongue) allergen extract approved in the United States. After administration of the first dose at the health care provider’s office, where the patient can be observed for potential adverse reactions, Oralair can be taken at home.
Allergic rhinitis with or without conjunctivitis are chronic diseases affecting children and adults. These allergic diseases affect approximately 30 million people in the United States and more than 500 million persons worldwide. These diseases are often caused by sensitivity to grass pollen. Affected people may suffer from repetitive sneezing, nasal itching, runny nose, nasal congestion, and itchy and watery eyes.
“While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The approval of Oralair provides an alternative to allergy shots that must be given in a health care provider’s office. Oralair can be taken at home after the first administration.”
Oralair is a once-daily tablet that rapidly dissolves after it is placed under the tongue. Oralair is started four months before the start of the grass pollen season and continued throughout the season. The first dose is taken at the health care provider’s office, where the patient is to be observed for at least 30 minutes for potential adverse reactions.
Oralair contains a mixture of freeze-dried extracts from the pollens of five grasses, including Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal and Timothy.
The safety and effectiveness of Oralair was evaluated in studies in the United States and Europe, involving approximately 2,500 people. Some patients received Oralair; others received an inactive substitute (placebo). To assess the effectiveness, patients reported their symptoms and additional medications needed to get through the allergy season. During treatment for one grass pollen season, patients taking Oralair experienced a 16 to 30 percent reduction in symptoms and the need for medications compared to those who received a placebo.
The prescribing information includes a boxed warning that severe allergic reactions (such as anaphylaxis, which can be life-threatening) can occur. Oralair also has a medication guide for distribution to the patient. The most common adverse reactions reported by adults were itching in the ears and mouth and of the tongue, as well as swelling of the mouth and throat irritation. In children, the most commonly reported adverse reactions were itching and swelling in the mouth and throat irritation.
Oralair is manufactured by Stallergenes S.A. of Antony, France.
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Allergenics