Association of Food and Drug Officials

AFDO Blog

  • July 19, 2012 11:00 AM | Anonymous
    The National Conference of State Legislatures analyzed 37 laws passed in 27 states during 2012 [View Report].
  • July 18, 2012 4:21 PM | Anonymous
    Katherine Simon, R.E.H.S.
    Food Inspector III
    Minnesota Department of Agriculture

    Katherine is currently a Food Inspector III for the Dairy and Food Inspection Division of the Minnesota Department of Agriculture. Katherine attended Iowa State University and, in 2004, was awarded a Bachelor of Science in the field of Animal Science. Her first professional experience in food safety was as a Food Inspector for USDA Food Safety Inspection Service.  In 2006, Katherine transitioned to inspecting for the food program at the Minnesota Department of Agriculture. The Minnesota Department of Health issued her Registered Environmental Health Specialist credential in 2008.  During this period, Katherine pursued additional graduate education in the field of professional agriculture and food safety from the graduate college at Iowa State University and School of Public Health at the University of Minnesota.

  • July 06, 2012 3:06 PM | Anonymous
    For Immediate Release: July 3, 2012
    Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
    Consumer Inquiries: 888-INFO-FDA

    Today, in response to requirements in legislation that passed Congress with broad bipartisan support, the U.S. Food and Drug Administration proposed that most medical devices distributed in the

    United States carry a unique device identifier, or UDI.

    A UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups and conducted four pilot studies in the development of this proposed rule. The FDA is seeking comment on the proposal for 120 days.

    “The safety of medical devices is a top priority for the FDA, Congress, industry, and patients,” said FDA Commissioner Margaret A. Hamburg, M.D. “The unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance our ability to improve patient safety.” 

    With certain exceptions, under the proposed rule, a UDI would include:

    ·         a device identifier, which is a unique numeric or alphanumeric code specific to a device model; and

    ·         a production identifier, which includes the current production information for a device.

    The FDA is proposing a risk-based, phased-in approach to implementation, focusing on the highest-risk medical devices first and exempting low-risk devices from some or all of the requirements. The FDA is proposing to exempt over-the-counter devices sold at retail; these devices generally have UPC codes in place.

    A UDI is a unique numeric or alphanumeric code that acts as a key to certain basic identifying information about a device, such as the name of the manufacturer and the type of device, and may represent certain other information about the device, such as its expiration date and batch or lot number. This information will be contained in a publicly available UDI database, and no identifying patient information will be stored in this device information center.

    The proposed rule reflects the considerable input the FDA received from the medical device industry, the clinical community, patients and consumers, and industry experts. To minimize industry costs and expedite implementation, the proposed rule builds upon current standards and systems already in use by some companies.

    A UDI system can provide multiple benefits, including:

    ·         Allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.

    ·         Reduce medical errors by enabling health care professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.

    ·         Provide a consistent way to enter information about devices in electronic health records and clinical information systems.

    ·         Provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.

    ·         Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.

    For more information:

    Proposed Rule: Unique Device Identification System
  • July 06, 2012 3:04 PM | Anonymous

    The U.S. Food and Drug Administration (FDA) is announcing that five perfluorinated substances used as greaseproofing agents have been voluntarily removed from interstate commerce by their manufacturers. After recent studies raised safety concerns with one type of perfluorinated chemicals, known as C8 compounds, FDA initiated a comprehensive review of the available data on C8 compounds. As a result of FDA’s initiative, manufacturers of these substances agreed to cease sale of all greaseproofing agents containing C8 perfluorinated compounds into the marketplace. This means that the affected products will no longer be sold for application on paper or paperboard intended for food contact use. This commitment is noted on FDA's Inventory of Effective Food Contact Substance (FCS) Notifications. This Inventory is the main mechanism by which FDA informs both the public and industry of substances regulated through the FCN program. FDA will also conduct a market survey of food packaging to ensure that these compounds are no longer used in material that comes in contact with human or animal food. 

    For additional background information, correspondence between FDA and industry, and other resource, see Update on Greaseproofing Agents.

  • July 06, 2012 2:57 PM | Anonymous

    Oct 27-31 2012 -- Registration And Housing Are Now Open for Reservations
    http://www.cardiocongress.org



    Ottawa ON Canada  -- Medical E-Mail News™ / July 03 2012 -- The 2012 Canadian Cardiovascular Congress (CCC) -- the largest and most prestigious gathering of cardiovascular and allied health professionals -- has opened its registration and housing sites, it was announced today.

    This year, more than 4,000 delegates are expected to attend the Toronto event on October 27-31 2012. The CCC attracts physicians, researchers, nurses, medical students, and allied health professionals.

    Every year, the Canadian Cardiovascular Society and the Heart and Stroke Foundation of Canada invite cardiovascular researchers from across Canada to submit their work to be considered for a presentation at the CCC. The scientific program features oral sessions, workshops, lectures by leading researchers and presentations of practice guidelines and position statements.

    Reasons to attend:

    • Network with more than 4,000 cardiovascular health care professionals
    • Learn about the latest cardiovascular research in Canada
    • Discover the most innovative products and services in high-quality patient care
    • Visit one of the most energetic and culturally diverse cities in North America

    Key Dates:

    • Registration is open and early bird rates are available until August 7 2012
    • Once delegates register, they can book their downtown hotel within walking distance to
      the Metro Toronto Convention Centre with the benefit of negotiated preferred rates

      Note: The call for late breaking and featured clinical trials closed July 2 2012 at midnight EDT

    Contact information:

    For all submission guidelines and key information for presenters: abstracts@ccs.ca

    Interested in supporting/sponsoring the CCC?    Get the Exhibitor/Supporter Prospectus
    Or Contact: cardiocongress@intertaskconferences.com

    Interested in exhibiting at Congress? Contact ccc-exhibits@intertaskconferences.com

    FOLLOW CCC2012 on Twitter
    LIKE CCC2012 on Facebook

    FAQS

    For further information please contact:

    CCC Secretariat
    c/o Intertask Conferences
    275 Bay St
    Ottawa ON K1R 5Z5 Canada
    613-238-2304 phone
    866-317-8461 phone
    613-236-2727 fax
    General E-mail:    cardiocongress@intertaskconferences.com
    Exhibitors' E-mail: ccc-exhibits@intertaskconferences.com
    http://www.cardiocongress.org


    ©Copyright 2012. Biomedical Market Newsletter Inc. All rights reserved.
    Please forward this release to colleagues who may want to read it.
  • July 06, 2012 2:53 PM | Anonymous
    Tallahassee, FL – Commissioner of Agriculture Adam Putnam sent a letter today to Acting Secretary of Commerce Rebecca Blank urging the U.S. Department of Commerce to accept the tomato industry’s request for withdrawal of the 1996 antidumping petition and terminate the current suspension agreement. 

    In 1996, tomato growers in Florida and across the United States, with support from the Florida Department of Agriculture and Consumer Services, filed the antidumping petition requesting relief from unfairly traded imports of fresh tomatoes from Mexico. The 2008 Suspension Agreement, which resulted from the 1996 antidumping petition, was intended to prevent trading partners from undercutting U.S. prices and devastating domestic production. 

    “Gone unrecognized by new producers in Mexico and unenforced by the U.S. Department of Commerce, the 2008 Suspension Agreement has done little to protect Florida’s tomato growers from unfair competition,” said Commissioner Putnam in the letter.

    “Tomato imports reached roughly $1.8 billion last year, three times the value they were when the petition was originally filed in 1996; yet, there has been virtually no change in the underlying reference price in the suspension agreement.”

    “Already suffering from weak demand in a difficult economy, Florida’s tomato growers cannot compete in a market flooded by unprecedented imports of tomatoes from Mexico at prices well below the cost of production.”

    Earlier this week, the tomato industry filed documents with the U.S. Department of Commerce and the U.S. International Trade Commission to withdraw the petition, thereby terminating the suspended investigations and the current suspension agreement.

  • July 06, 2012 2:47 PM | Anonymous

    The Food and Drug Administration (FDA), Office of Food Defense, Communication and Response (OFDCER), Food Defense Oversight Team (FDOT), in collaboration with the National Association of City and County Health Officials (NACCHO) and the

    National Center for Food Protection and Defense (NCFPD), is providing an interactive Food Defense Workshop via live webinar from the NACCHO annual conference.

    Session Objectives:           

    This interactive workshop will provide attendees an opportunity to learn from the FDA about some of our current and future food defense planning tools and resources, while also providing exposure to the latest tool the - Food Related Emergency Exercise Bundle (FREE-B).

    A demonstration of the FREE-B will be held via a walk-through of one of the exercises, illustrating how flexible and functional these scenarios are in addressing the needs of our State, local, Tribal and territorial regulatory partners.

    Highlights from several FDA based funding opportunities will also be discussed, and successes realized will be shared with the attendees, in the hopes of inspiring them to pursue these funding opportunities in the future.

    When: July 11, 2012; 12:30 – 2:30 pm Pacific Time (9:30 – 11:30 am EST)

    Where: The webinar will be presented from the NACCHO annual conference,

    Los Angeles, CA .  Webinar registration information is available online at www.FoodSHIELD.org or by clicking here.

    Presenter: Jason Bashura, FDA's Food Defense Oversight Team (Jason.Bashura@fda.hhs.gov)

    For additional information on this workshop, please contact the Food Defense Oversight Team, at FoodDefense@fda.hhs.gov.

    For additional Information on the FREE-B, see the FREE-B Flyer.

    The Food Defense Oversight Team (FDOT) oversees food defense activities of the FDA, developing and implementing procedures to prevent, prepare for, respond to, and recover from intentional contamination affecting the FDA regulated food industry. FDOT is responsible for data collection and analysis, policy development and both domestic and international outreach efforts in food defense.
  • July 06, 2012 1:54 PM | Anonymous
    Claudia Coles is the Administrator of the Office of Compliance and Outreach within the Food Safety and Consumer Services Division of the Washington State Department of Agriculture (WSDA).  Previous WSDA positions Claudia has held include the Food Safety Program Manager, Assistant Compliance Program Manager, Regional Food Safety Supervisor, Food Safety Officer and Microbiologist.

    The WSDA Food Safety and Consumer Services Division is also home of the Food Safety, Microbiology Laboratory, Organic Food and Dairy Nutrient Management Programs.  

    Claudia is a member of numerous National Food Safety Committees such as the Association of Food and Drug Officials where she is President, the National Conference of Interstate Milk shippers and holds a variety of board positions on Regional and National Food Safety Associations.  Claudia is also a Past President of Western Association of Food and Drug Officials (WAFDO) and the National Association of Dairy Regulatory Officials (NADRO).  
    Claudia has received five awards from the Commissioner of the US Food and Drug Administration for her consistent leadership in food safety, Seafood HACCP, Interstate Milk Shippers Conference committees such as Dairy HACCP and the International Certification Pilot Program, training teams, and promoting state and federal partnerships.

    Claudia earned her Bachelor of Science in Food Science from North Dakota State University and she is a Class 14 graduate of the Washington Agriculture and Forestry Leadership Program.

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