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title: "EAS-e-News: What’s Hot in the Regulatory World"
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Friend, Get the latest FDA and USDA regulatory information in our monthly EASeNews.

| View in browser Foods  •  Dietary Supplements  •  Drugs  •  Medical Devices  •  Cosmetics  •  Tobacco  •  Cannabis 1700 Diagonal Road, Suite 750, Alexandria, VA 22314  •  571-447-5500  •  easconsultinggroup.com/contact March 2025 Issue of the Month Salmonella Framework for Raw Poultry Products by Dionne S. Meehan, EAS Consulting Group Independent Consultant On August 7, 2024, the United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) published its updated “Salmonella Framework for Raw Poultry Products” consisting of a proposed rule and proposed determination that would declare Salmonella an adulterant in raw poultry under certain circumstances.   FSIS is proposing to declare Salmonella an adulterant in raw poultry when Salmonella is present at greater than 10 CFR/g or ml and certain serotypes of public health concern are present. In addition, FSIS is proposing to revise regulations in 9 CFR 381.65(g) and (h) to require that poultry slaughter establishments incorporate statistical process control (SPC) monitoring principles into their microbial monitoring programs (MMPs) and submit microbial monitoring sampling results to FSIS electronically and to require additional sampling at certain processing steps. Read Full Article Under the Microscope Hygiena BAX® SalQuant™: A Simpler and More Cost-Effective Means of Providing Salmonella Quantification Information As a member of the Certified Group and Food Safety Net Services, EAS clients have access to world-renowned testing laboratories that meet your organization’s sophisticated needs. In this column, you’ll hear about their capabilities, environmental challenges and more. We hope you’ll enjoy a look “under the microscope.” by Rhaisa A. Crespo, Ph.D., Research Scientist   In food microbiology, all test methods fall into one of two categories: qualitative methods or quantitative methods. Qualitative methods are very specific for a particular analyte (usually a pathogen that one expects to be present at a low concentration), and are designed to tell the user whether the food sample is “positive” or “negative” for that analyte. This testing approach usually involves incubating a food sample in a nutritious liquid medium (i.e. enriching) to make a single cell multiply into millions of cells. The incubated mixture is then tested with a detection assay such as a Polymerase Chain Reaction Assay (PCR) or Enzyme-Linked Fluorescence Assay (ELFA) that gives a “positive” or “negative” result. In general, one will have zero tolerance for any amount of an analyte tested via a qualitative method, so the “positive” or “negative” result is sufficient. Read Full Article Upcoming Training Events The Role of Your US Agent Webinar March 18, 2025   Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar April 1, 3, 8, 10, 2025   Food and Dietary Supplement Labeling Compliance Seminar April 28, 30, May 2, 2025   Drug OTC GMPs and Labeling Seminar Series May 6, 13, 20, 27, and June 3, 2025 Upcoming Tradeshows and Conferences SOT 64th Annual Meeting & ToxExpo Orlando, FL March 16-20, 2025 Visit us at Labstat Booth 1350!   Seafood Expo North America Boston, MA March 16-18, 2025 Visit us at Certified Labs Booth 681!   FDLI Food and Dietary Supplement Safety and Regulation Conference Washington, DC March 25, 2025 Event Sponsor   American Tobacco & Nicotine Forum Arlington, VA April 15-17, 2025 Event Sponsor, Exhibitor   Petfood Forum Kansas City, MO April 28-30, 2025 Visit us at FSNS Booth 1819!   ASQ’s World Conference on Quality & Improvement Denver, CO May 4-7, 2025   Food Safety Summit Rosemont, IL May 12-15, 2025 Visit Certified Group at Booth 426!   PCPC Legal and Regulatory Conference New Orleans, LA May 13-15, 2025   FDLI Annual Conference Washington, DC May 15-16, 2025 Event Sponsor  Food Safety Net Services (FSNS) Education Interested in more food safety training? FSNS offers live and virtual education events. Visit FSNS.com/education to learn more. FSPCA Preventive Controls for Animal Food or Human Food (PCQI)   HACCP Training Course   Advanced HACCP/Preventive Controls    FSSC 22000 and/or Internal Auditing   Microbiology and Food Safety 101 and 202   Preventive Maintenance   Sanitation Courses   Implementing SQF Systems Ed 9 and Internal Auditing   BRCGS Food – Issue 9 Sites Training and/or Internal Auditing   and many more... FDA and USDA Regulatory Updates 2024 CARES Act Drug Volume Reporting Reminder Cosmetic Registration and Listing Requirement Reminder EAS in Action EAS is on the go. Find out about our latest seminars, webinars, speaking engagements, articles published in industry journals, tradeshows and more! Last Chance to Register: The Role of Your US Agent New for 2025: The Role of Your US Agent. An EAS complimentary webinar presented by EAS’ Victoria Pankovich and Lisa El-Shall on Tuesday, March 18, 2025, at 1pm ET.   Foreign entities who operate in US FDA regulated industries must have an appointed US Agent before doing business and importing products into the US. US Agents act as an intermediary between the foreign company and FDA, assisting with two-way communication on requirements and questions such as establishment registrations and product listings; submissions such as Foreign Color Manufacturers Testing and Approval through FDA; drug submissions such as IND, DMF, ANDA and their required submissions (Annual Reports, Amendments, LoAs); and medical device applications such as 510(k), 513(g), deNovo, etc.   Register today: https://easconsultinggroup.com/the-role-of-your-us-agent/ Dietary Supplement GMP Seminar EAS Consulting Group’s Dietary Supplement GMP Seminar helps firms prepare for FDA enforcement by facilitating an understanding of compliance requirements for responsibilities of domestic and foreign firms who manufacture, label, pack or hold dietary supplements for sale in the United States, including those involved with the testing, quality control and distribution of supplements. Instructed by two cGMP experts with 30+ years combined industry experience this intensive training program will help your firm stay on top of cGMP requirements.   Register today: https://easconsultinggroup.com/events/seminars/dietary-supplement-gmp-compliance/   This four-day virtual seminar will take place April 1, 3, 8, and 10, 2025, from 11am-4pm ET each day. Food and Dietary Supplement Labeling Compliance Seminar Registration is now open for our biannual Food and Dietary Supplement Labeling Compliance Seminar.   As the food and supplement industries turn their focus to compliance with the latest FDA guidance for labeling regulations, the significance of those changes and how they influence nutrition and supplement facts panels, as well as claims are raising questions. Our experts will walk you through the requirements of a label, what information is required and in what order, how to determine amounts and how to list ingredients. You’ll learn the complex set of labeling rules and get answers to your most challenging questions.   Register today: https://easconsultinggroup.com/events/seminars/food-and-dietary-supplement-labeling-compliance-seminar/   This three-day virtual seminar will take place April 28, 30, and May 2, 2025, from 11am-5pm ET each day. Drug OTC GMPs and Labeling Seminar Series Our exclusive five-part series includes: Registration and Listing Requirements, Adverse Events Reporting, OTC Labeling and Monographs, Compliance Inspection Enforcement, and Private Label Distributor Requirements.   Register today: https://easconsultinggroup.com/drug-otc-gmps-and-labeling/   This five-part virtual seminar, consisting of five one-hour sessions, will take place May 6, 13, 20, 27, and June 3, 2025, starting at 1pm ET each day. Visit Us at Seafood Expo/Seafood Processing North America The 2025 Seafood Expo and Seafood Processing North America is happening March 16-18 in Orlando, FL. Meet EAS’ Mark Moen and the Certified Laboratories, Inc. team at Booth #681! This year’s event will feature more than 30 educational sessions led by top seafood industry experts. Attendees will take away engaging and practical information covering the most important and timely issues relevant to today’s seafood business environment. Learn more: https://www.seafoodexpo.com/north-america/ Visit Us at Society of Toxicology Annual Meeting & ToxExpo The Society of Toxicology’s 64th Annual Meeting & ToxExpo will take place March 16-20 in Orlando, FL! Join EAS’ Maged Sharaf and the Labstat team at Booth #1350, along with leading toxicologists and industry professionals as they dive into cutting-edge science and technology. Proud Sponsors of FDLI’s Food and DS Safety and Regulation Conference Join FDLI for their annual Food and Dietary Supplement Safety and Regulation Conference on March 25, 2025, in Washington, DC, and Virtually.   This event brings together leading regulators, attorneys, industry representatives, academics, consumer advocates, and consultants to discuss current issues and trends in food and dietary supplement regulation with a focus on product safety. Topics will include federal and state regulatory compliance, inspections and recalls, updated ingredient safety and regulation under the new administration, product innovation, and novel technologies. This is a must-attend event for all stakeholders involved in food and dietary supplement policy, regulation, compliance, manufacturing, and technology.   Learn more: https://www.fdli.org/2025/03/2025-food-and-dietary-supplement-safety-and-regulation-conference/ EAS In the News: Paula Brock, Food Safety Tech Read Food Safety Tech’s feature on “Food and Dietary Supplement Labeling: What Comes Next?” by EAS Consulting Group’s Paula Brock. Read online: https://foodsafetytech.com/feature\_article/food-and-dietary-supplement-labeling-what-comes-next/ Submit Your Questions to the EAS Team Today! Do you have a regulatory question or concern? Are you interested in seeing a particular topic covered in a future issue of eNews? We want to hear from you! Use the EAS Contact Us form to send a note or question to our team any time. Get Notified When Trainings Are Scheduled Are you looking for training in a particular industry or regulatory topic? Review our list of available topics and sign up to be notified when your course of interest is scheduled next. We’re Hiring Independent Contractors! EAS is always interested in broadening our industry experience and expanding our independent consultant team. If you’re interested in joining EAS as a 1099 contract employee, please email your CV to Dean Cirotta at dcirotta@easconsultinggroup.com. Consultant Corner EAS offers over 150 independent consultants strategically located around the globe whose expertise provide core value for clients. Issue of the Month Author Dionne Meehan EAS Consulting Group, EAS Independent Consultant Dionne Meehan is an accomplished Senior Regulatory Professional with over 15 years of leadership experience in food safety quality regulatory compliance for food processing and manufacturing industries. Meehan is a recognized expert in FSIS, USDA, and FDA regulatory systems, with a proven track record of securing FSIS regulatory exceptions, implementing innovative compliance strategies, and delivering measurable value to organizations. She is adept at fostering cross-functional collaboration among R&D, Sales, Marketing, and Operations to align regulatory solutions with business objectives, and demonstrates exceptional leadership in risk management, regulatory policy development, and international trade compliance, driving operational excellence and productivity savings. Meet New EAS Consultant Mark Kantor EAS Consulting Group, EAS Independent Consultant Mark Kantor’s professional career has been at the intersection of food science and nutrition, including positions in government, academia, and industry. He was a nutrition scientist and regulation writer in FDA’s Office of Nutrition and Food Labeling for 14 years (2010-2024) where he contributed to the 2016 updates to the Nutrition Facts and Supplement Facts labels and Serving Size regulations. He also assisted in evaluating and responding to numerous citizen petitions pertaining to health claims and dietary fiber, and in writing the 2025 proposed rule on front-of-pack labeling.   Prior to joining FDA, he was a faculty member at the University of Maryland for 25 years, where he taught and did research in the Dept. of Nutrition and Food Science, mentored graduate and undergraduate students, and conducted educational outreach programs through the Cooperative Extension Service. Mark has in-depth knowledge of FDA’s nutrition labeling and health claim regulations and vast experience in delivering presentations to both professional and consumer audiences. Learn more about working with EAS Consulting Group 👍 So the World Can Trust in What It Consumes EAS Consulting Group, 1700 Diagonal Road, Suite 750, Alexandria, VA 22314, USA, (571) 447-5500 Manage preferences |
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