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.
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.
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.
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.
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.
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.
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/
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.
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.
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.
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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.
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