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  • September 10, 2014 11:18 AM | Anonymous


    USA Jobs Announcement: https://www.usajobs.gov/GetJob/ViewDetails/379023200

    Job Announcement Number: FDA-ORA-14-SL-1195986

    The Office of Partnerships is announcing the vacancy position of Director of Office of Partnership.  This position reports to the Deputy Associate Commissioner for Regulatory Affairs (DACRA), Office of Regulatory Affairs (ORA), Office of Global Regulatory Operations and Policy (OGROP), within the Food and Drug Administration (FDA) in Rockville, Maryland. 

    The incumbent serves as the Director, Office of Partnerships in the Office of Regulatory Affairs (ORA) in the Office of Global Regulatory Operations and Policy (OGROP).  As the Director, the incumbent serves as the Senior Partnerships Program Officer, who will be a key member of the senior management team of the Associate Commissioner for Regulatory Affairs (ACRA)/DACRA which has responsibilities for decision making processes and leads discussions and decision-making concerning ORA plans, programs, and activities, both during strategic planning sessions and in the actual determination, allocation, and administration of ORA program segments(s), functions, and activities.

    The incumbent provides expert advice and counsel concerning approaches and options that are sound and feasible in relation to ORA's regulatory goals and objectives.  As the Director, OP, the incumbent serves as the principal advisor to the ACRA/DACRA and is recognized as the person who can speak authoritatively for the ACRA/DACRA on matters pertaining to the FDA/ORA partnership programs.

    The incumbent represents the agency in meetings, conference, and committees involving policy and other matters pertinent to partnership programs; coordinates programs with State, local, and foreign governments and other Federal agencies concerning the interpretation of regulatory requirements, impacts, and other issues.

    The incumbent represents the ACRA/DACRA with State, local and foreign regulatory and scientific entities, providing strategic recommendations and facilitating the development of stronger working relationships and new cooperative agreements and partnerships.  Also represents the ACRA/DACRA in dealing with and negotiating with representatives of Congress; HHS Operating Divisions, other Federal agencies; State, local, and, at times, foreign governments; the regulated industry; professional and industry organizations; and public interest groups. 

    Oversees the implementation of new laws and regulations which impact the mission of ORA.  This includes responsibility for the initiation and implementation of new policies, systems, and procedures.

    The incumbent is responsible for analysis of the impact of proposed changes to Agency laws and regulations, policies, and procedures which affect the functions, program segment(s), and activities of ORA's HQ and field offices that are involved with partnership efforts.  Identifies changes and additions to the functions, program segment(s), and activities of ORA necessary to implement new legislation or regulations, and develops various scenarios for dealing with expansion or contraction of ORA functions, program segment(s), and activities in relation to partnership efforts.

    The incumbent oversees, monitors, evaluates and provides guidance on the effectiveness of all ORA partnership activities.  Provides guidance on matters which cannot be resolved at the local level and coordinates efforts amongst the various offices.

    Directs the staff of OP and is responsible for the technical and administrative supervision through subordinate supervisors and/or team leaders of all Office employees which includes planning, assigning, reviewing, and evaluating the work and performance of those supervisors (or team leaders) and employees.  The Office Director is recognized as the authority in the functions, and activities of OP.

  • September 02, 2014 11:01 AM | Anonymous


    Agricultural Marketing Service

    Notice: United States Standard of Identity for Honey

    Rule: Decreased Assessment Rates: Domestic Dates Produced or Packed in Riverside County, CA

    Rule: Irish Potatoes Grown in Washington: Handling Regulations for Yellow Fleshed and White Types of Potatoes

    Federal Trade Commission

    Proposed Rule: Children's Online Privacy Protection Rule: AgeCheq Application for Parental Consent Method

    Food and Drug Administration

    Notice: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, etc

    Notice: Agency Information Collection Activities; Proposals, Submissions, and Approvals:

    Temporary Marketing Permit Applications

    Notice: Agency Information Collection Activities; Proposals, Submissions, and Approvals:

    Third Party Disclosure and Recordkeeping Requirements for Reportable Food

    Charter Renewals: Advisory Committees

    Meeting: Codex Alimentarius Commission Committee on Food Labeling

    Proposed Rules: Food Additives; Petitions: Richard C. Theuer; Withdrawal

    Food and Nutrition Service

    Notice: Agency Information Collection Activities; Proposals, Submissions, and Approvals: User Access Request Form

    Food Safety and Inspection Service

    Back-To-School Food Safety Tips for Parents

    Special Alert: FSIS Releases Revised Guidance concerning Shiga toxin-producing E. coli (STEC) Sampling in Beef Manufacturing Trimmings and STEC Sampled and Tested Claims for Beef Manufacturing Trimmings

    FSIS Compliance Guideline for Training Establishment Carcass Sorters in the New Poultry Inspection System

    Notice: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Inspection, Accreditation of Laboratories, and Exemptions

    Government Accountability Office

    Enhanced Detection Tools and Reporting Could Improve Efforts to Combat Recipient Fraud                                                             


  • August 18, 2014 1:53 PM | Anonymous

    Courtesy: CFSAN Constituent Update, August 5, 2014 Ed.

    As of today, all foods labeled gluten-free must meet all requirements of the gluten-free labeling final rule published in August 2013.

    The requirements apply to packaged foods labeled on or after today. FDA recognizes that many foods currently labeled as gluten-free may already meet the new federal definition. However, consumers should be aware that there may be some products still on store shelves that were produced and labeled before the compliance date for FDA’s rule.

    Today’s compliance date was established in the final rule one year ago to allow the food industry sufficient time to make changes needed in the formulation or labeling of their foods that voluntarily bear a gluten-free claim in the United States.

    The final rule provides a uniform standard definition to help consumers with celiac disease manage a gluten-free diet. Gluten-free foods must contain less than 20 parts per million (ppm) gluten. Foods may be labeled “gluten-free” if they are inherently gluten free; or do not contain an ingredient that is: 1) a gluten-containing grain (e.g., spelt wheat); 2) derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or 3) derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 ppm or more gluten in the food.

    On June 25, 2014, the FDA issued a guide for small food businesses to help them comply with the final rule's requirements. FDA will continue to work with, educate and monitor industry on the use of the gluten-free claim.

    Outreach will be conducted to assist the industry, as needed, to ensure that the provisions of the rule are fully understood. In addition, FDA will use its existing compliance and enforcement tools, such as inspection, laboratory analysis, warning letters, seizure, and injunction, to ensure that the use of the claim on food packages complies with the definition.

    FDA recognizes that people with celiac disease are also interested in being able to identify gluten free foods served in restaurants and other retail establishments that serve prepared foods to customers. The gluten-free final rule applies to packaged foods, which may be sold in some retail and food-service establishments such as some carry-out restaurants. Given the public health significance of “gluten-free” labeling, FDA says that restaurants and other establishments making a gluten-free claim on their menus should be consistent with FDA’s definition. State and local governments play an important role in oversight of these establishments.

    We look forward to working with the states, the restaurant industry and other stakeholders to support education and outreach on the appropriate use of the term gluten-free.

    For additional information: www.fda.gov/gluten-freelabeling

    As of today, all foods labeled gluten-free must meet all requirements of the gluten-free labeling final rulepublished in August 2013.

    The requirements apply to packaged foods labeled on or after today. FDA recognizes that many foods currently labeled as gluten-free may already meet the new federal definition.  However, consumers should be aware that there may be some products still on store shelves that were produced and labeled before the compliance date for FDA’s rule.

    Today’s compliance date was established in the final rule one year ago to allow the food industry sufficient time to make changes needed in the formulation or labeling of their foods that voluntarily bear a gluten-free claim in the United States.

    The final rule provides a uniform standard definition to help consumers with celiac disease manage a gluten-free diet.  Gluten-free foods must contain less than 20 parts per million (ppm) gluten. Foods may be labeled “gluten-free” if they are inherently gluten free; or do not contain an ingredient that is: 1) a gluten-containing grain (e.g., spelt wheat); 2) derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or 3) derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 ppm or more gluten in the food.

    On June 25, 2014, the FDA issued a guide for small food businesses to help them comply with the final rule's requirements.  FDA will continue to work with, educate and monitor industry on the use of the gluten-free claim.

    Outreach will be conducted to assist the industry, as needed, to ensure that the provisions of the rule are fully understood.  In addition, FDA will use its existing compliance and enforcement tools, such as inspection, laboratory analysis, warning letters, seizure, and injunction, to ensure that the use of the claim on food packages complies with the definition.

    FDA recognizes that people with celiac disease are also interested in being able to identify gluten free foods served in restaurants and other retail establishments that serve prepared foods to customers. The gluten-free final rule applies to packaged foods, which may be sold in some retail and food-service establishments such as some carry-out restaurants. Given the public health significance of “gluten-free” labeling, FDA says that restaurants and other establishments making a gluten-free claim on their menus should be consistent with FDA’s definition.  State and local governments play an important role in oversight of these establishments.

    We look forward to working with the states, the restaurant industry and other stakeholders to support education and outreach on the appropriate use of the term gluten-free.

    For additional information: www.fda.gov/gluten-freelabeling

    As of today, all foods labeled gluten-free must meet all requirements of the gluten-free labeling final rulepublished in August 2013.

    The requirements apply to packaged foods labeled on or after today. FDA recognizes that many foods currently labeled as gluten-free may already meet the new federal definition.  However, consumers should be aware that there may be some products still on store shelves that were produced and labeled before the compliance date for FDA’s rule.

    Today’s compliance date was established in the final rule one year ago to allow the food industry sufficient time to make changes needed in the formulation or labeling of their foods that voluntarily bear a gluten-free claim in the United States.

    The final rule provides a uniform standard definition to help consumers with celiac disease manage a gluten-free diet.  Gluten-free foods must contain less than 20 parts per million (ppm) gluten. Foods may be labeled “gluten-free” if they are inherently gluten free; or do not contain an ingredient that is: 1) a gluten-containing grain (e.g., spelt wheat); 2) derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or 3) derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 ppm or more gluten in the food.

    On June 25, 2014, the FDA issued a guide for small food businesses to help them comply with the final rule's requirements.  FDA will continue to work with, educate and monitor industry on the use of the gluten-free claim.

    Outreach will be conducted to assist the industry, as needed, to ensure that the provisions of the rule are fully understood.  In addition, FDA will use its existing compliance and enforcement tools, such as inspection, laboratory analysis, warning letters, seizure, and injunction, to ensure that the use of the claim on food packages complies with the definition.

    FDA recognizes that people with celiac disease are also interested in being able to identify gluten free foods served in restaurants and other retail establishments that serve prepared foods to customers. The gluten-free final rule applies to packaged foods, which may be sold in some retail and food-service establishments such as some carry-out restaurants. Given the public health significance of “gluten-free” labeling, FDA says that restaurants and other establishments making a gluten-free claim on their menus should be consistent with FDA’s definition.  State and local governments play an important role in oversight of these establishments.

    We look forward to working with the states, the restaurant industry and other stakeholders to support education and outreach on the appropriate use of the term gluten-free.

    For additional information: www.fda.gov/gluten-freelabeling

  • August 18, 2014 1:39 PM | Anonymous


    Courtesy: USDA Constituent Update, August 8, 2014 Ed.

    View Revised Guidelines

    FSIS issued a revised compliance guideline this month called, “FSIS Compliance Guideline for Meat and Poultry Jerky Produced by Small and Very Small Establishments.” The purpose of the guideline is to assist establishments in meeting FSIS regulations related to jerky processing. The guideline also contains recommendations to help industry produce a safe product based on the scientific information available in the literature.

    FSIS has updated the guideline based on comments received on the July 2012 version. FSIS also updated the guideline based on AskFSIS questions received. Changes made to the guideline include the addition of a surface preparation step in the step-by-step guide on jerky processing, clarification of the definition of shelf-stability and recommended shelf-stability parameters, and clarification of the documentation that establishments should collect to support that their process effectively addresses hazards. A detailed summary of the comments and FSIS’ responses can be found in the document.

    FSIS encourages small and very small meat and poultry establishments that manufacture these products to avail themselves of this guideline. FSIS has posted this compliance guideline on its Compliance Guides Index webpage at http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index.

    Questions on the revised compliance guideline and directive can be submitted through AskFSIS.

    FSIS issued a revised compliance guideline this month called, “FSIS Compliance Guideline for Meat and Poultry Jerky Produced by Small and Very Small Establishments.” The purpose of the guideline is to assist establishments in meeting FSIS regulations related to jerky processing. The guideline also contains recommendations to help industry produce a safe product based on the scientific information available in the literature.

    FSIS has updated the guideline based on comments received on the July 2012 version. FSIS also updated the guideline based on AskFSIS questions received. Changes made to the guideline include the addition of a surface preparation step in the step-by-step guide on jerky processing, clarification of the definition of shelf-stability and recommended shelf-stability parameters, and clarification of the documentation that establishments should collect to support that their process effectively addresses hazards. A detailed summary of the comments and FSIS’ responses can be found in the document.

    FSIS encourages small and very small meat and poultry establishments that manufacture these products to avail themselves of this guideline. FSIS has posted this compliance guideline on its Compliance Guides Index webpage athttp://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index.

    Questions on the revised compliance guideline and directive can be submitted through AskFSIS.

    FSIS issued a revised compliance guideline this month called, “FSIS Compliance Guideline for Meat and Poultry Jerky Produced by Small and Very Small Establishments.” The purpose of the guideline is to assist establishments in meeting FSIS regulations related to jerky processing. The guideline also contains recommendations to help industry produce a safe product based on the scientific information available in the literature.

    FSIS has updated the guideline based on comments received on the July 2012 version. FSIS also updated the guideline based on AskFSIS questions received. Changes made to the guideline include the addition of a surface preparation step in the step-by-step guide on jerky processing, clarification of the definition of shelf-stability and recommended shelf-stability parameters, and clarification of the documentation that establishments should collect to support that their process effectively addresses hazards. A detailed summary of the comments and FSIS’ responses can be found in the document.

    FSIS encourages small and very small meat and poultry establishments that manufacture these products to avail themselves of this guideline. FSIS has posted this compliance guideline on its Compliance Guides Index webpage athttp://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index.

    Questions on the revised compliance guideline and directive can be submitted through AskFSIS.

  • August 18, 2014 12:30 PM | Anonymous


    Courtesy: NCAFDO, The Informer Newsletter, August 2014 Ed.

    Our next NCAFDO Annual Education Conference is being finalized at this time; we will be in Cleveland, Ohio thanks to Lowell Lufkin and Terry Gerhardt’s work on setting it up. The Westin Cleveland Downtown and the Ohio Department of Agriculture will be our hosts. The dates for the conference are Monday, October 20 to Thursday, October 23, 2014. A workshop on labeling is organized for Monday and Tuesday morning and will focus on small processors and local health agencies. The official start of the conference is at noon on Tuesday and will wrap up by noon on Thursday.

    Lowell’s site visit confirms the hotel remodel was very successful and it will provide an excellent venue for the conference. The hotel is located downtown within walking distance of assorted restaurants and shops with access to the Rock and Roll Hall of Fame,baseball, and Severance Hall for those of us who like classical music. I have attended a couple conferences in downtown Cleveland and had a great time with both food, cultural opportunities and just enjoying the city. If you do fly in, there is public transit from the airport to downtown and a short walk of a few blocks to the hotel, along with the standard taxi and other options.

    We have also been working on our small conference grant to support attendance to the conference, and while we don’t have final confirmation from the Food and Drug Administration on its renewal, we do anticipate it should be renewed. The small conference grant is meant to support the attendance and education of regulatory officials at regional food safety training opportunities. Look for more details on our web site as they become available, or contact your state representative to NCAFDO.

    We are working on the program and will focus a bit
    on Listeria Monocytogenes (Lm):
    • The latest science and research in both the retail
    and wholesale food worlds;
    • How to develop and implement an effective
    sanitation program for the control of Lm; and,
    • How the Food Safety Modernization Act (FSMA)
    will affect these plans and facilities.

    Additionally, there will be updates on FSMA from our federal partners and any participants on the FDA implementation teams. So please save the dates and plan on attending. Looking forward to seeing you in Cleveland.

    Byron Beerbower
    NCAFDO President
  • August 04, 2014 11:00 AM | Anonymous

    Agricultural Marketing Service

    Vilsack Names Members to Fruit and Vegetable Industry Advisory Committee

    Animal and Plant Health Inspection Service

    Rule – National Poultry Improvement Plan and Auxiliary Provisions

    Rule – Approved Tests for Bovine Tuberculosis in Cervids

    Proposed Rules - Importation of Two Hybrids of Unshu Orange from the Republic of Korea into the Continental United States

    Proposed Rules - Restrictions on the Importation of Fresh Pork and Pork Products from a Region in Mexico

    Environmental Protection Agency

    Proposed Rule - Pesticide Petitions: Residues of Pesticide Chemicals in or on Various Commodities

    Food and Drug Administration

    Application for Participation in the Commissioner's Fellowship Program

    Food and Drug Administration Recall Regulations

    Food Safety Modernization Act: Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2015

                            

    The United States and Mexico sign statement of intent to strengthen produce safety

    FDA Announces New Information Sharing System for Federal and State Regulators

    Proposed Rule – Food Additives; Animal Use

    Notice - Agency Information Collection Activities; Proposals, Submissions, and Approvals: Experimental Study of Direct-to-Consumer Promotion Directed at Adolescents

    FDA to Hold Public Meeting on Antimicrobial Resistance Monitoring in the Food Supply

    Food and Nutrition Service

    Supplemental Nutrition Assistance Programs: Retailer Transaction Data

    Community Eligibility Provision: Guidance and Q&As

    Food Safety and Inspection Service

    USDA Announces Additional Food Safety Requirements, New Inspection System for Poultry Products

    Proposed Rule - Records to be Kept by Official Establishments and Retail Stores that Grind Raw Beef Products

    Proposed Rule - USDA Proposes Rule to Enhance Consumer Protection; Ensure Retailers Can Track Sources of Ground Meats

    Grain Inspection, Packers and Stockyards Administration

    Proposed Rule – United States Standards for Barley

  • August 04, 2014 10:17 AM | Anonymous


    View "Data Elements and Definitions" Document

    The Partnership for Food Protection (PFP) Governing Council is pleased to announce the release of a new PFP resource document entitled, “Data Elements and Definitions.”  We want to share this PFP work product with all of our valued partners and ask for your assistance in disseminating this document to your colleagues, as appropriate. The target audiences for this resource document are federal and state food safety and public health agencies to use as an information guide when updating or replacing information technology (IT) systems. 

    The “Data Elements and Definitions” resource document was developed by the PFP Information Technology Workgroup (ITWG). The Workgroup is co-chaired by Ashley Schascheck from the Michigan Department of Agriculture and Rural Development and Don Jaccard from the Food and Drug Administration’s Office of Foods and Veterinary Medicine, and includes representatives from federal, state and local government agencies.

    The ITWG developed and delivered a comprehensive landscape of data elements collected by state food manufacturing programs during licensure and inspection of food manufacturing firms. The information in the data landscape was analyzed, evaluated, and used to develop a common data dictionary as a means of creating a common lexicon in moving towards a vision of data sharing and exchange among regulatory partners. The document is comprised of a compilation of the 27 most common data elements used by both FDA and state food safety organizations. The dictionary definitions also provide a platform of accepted terms and usage to assist in aligning the variety of definitions that currently exist across jurisdictional lines.

    The PFP Governing Council thanks you for your continued interest in the Partnership’s work in the development of an Integrated Food Safety System and for sharing this document with your colleagues.

    Sincerely on behalf of the PFP Governing Council,

    Barbara Cassens, Food and Drug Administration, Office of Regulatory Affairs

    Patrick Kennelly, California Department of Public Health

    PFP Governing Council Co-chairs

  • August 04, 2014 10:07 AM | Anonymous


    The Rapid Response Teams (RRT) Program is pleased to announce an open call for revisions to the RRT Best Practices Manual, the purpose of which is to encourage RRT Program stakeholders to submit revisions to existing content and suggestions for new content as we prepare the 2015 (3
    rd) Edition of the RRT Best Practices Manual.

    The RRT Best Practices Manual documents best practices for developing capabilities for integrated food safety program responses to all‐hazards food/feed emergencies, providing a set of guidance, definitions, tools, and examples that organizations can use to incrementally develop these core capabilities. The RRT Program shares these completed documents with food safety partners as a tool to inform improvement of food emergency response, emphasizing the importance of effective collaboration among federal and state partners. The RRT Manual is updated biennially as programs, policies, scientific research and technologies evolve. Requests for an electronic PDF copy of the RRT Manual can be sent to OP-ORA@fda.hhs.gov.

    In preparing the 2015 Edition of the RRT Manual, we aim to update the RRT Manual to keep its content current and accurate and maintain the Manual’s status as the repository of best practices for integrated response teams. We are asking that all suggestions for revisions to existing content and/or suggestions for new content be submitted to Lauren.Yeung@fda.hhs.gov and Travis.Goodman@fda.hhs.gov by November 1st, 2014. Please feel free to contact us with any questions.

  • August 04, 2014 9:50 AM | Anonymous


    The Food and Drug Administration (FDA) is pleased to announce a series of webinars to provide information about funding opportunities that may be available to jurisdictions that are enrolled in the Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards). All retail food regulatory programs, including those that are not currently enrolled in the Retail Program Standards, are encouraged to attend one of the three webinars to learn more about potential funding opportunities. The information presented will be the same for all three webinars.

    The Retail Program Standards are designed to help retail food regulatory programs reduce foodborne illness associated with retail and foodservice establishments by promoting continuous improvement of food safety inspection programs.  Jurisdictions that are enrolled in the Retail Program Standards may be eligible to receive funding for completion of projects, training, and other activities to enhance conformance with the Standards.  Time will be provided at the end of each webinar for questions.

    The webinars will be held on the following dates:  

    • Wednesday, July 30, 2014 (2:30 – 3:45 PM EDT)
    • Tuesday, August 5, 2014 (2:00 – 3:15 PM EDT)
    • Thursday, August 7, 2014 (10:00 – 11:15 AM EDT)

    To access the audio portion:

    ·         Toll free: 888-469-2033

    ·         Participant passcode: 3128823


    To access the video portion:

    ·         Adobe Connect Link: https://collaboration.fda.gov/retail_food_standards/

    To obtain more information about the Retail Program Standards and a complete listing of the jurisdictions enrolled in the standards, please go to the following FDA internet websites:

    ·         Voluntary National Retail Food Regulatory Program Standards

    ·         Listing of Jurisdictions Enrolled in the Voluntary National Retail Food Regulatory Program Standards.

    Questions about the Retail Program Standards may be sent to the following email address: retailfoodprotectionteam@fda.hhs.gov.

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