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title: "EAS-e-News: What’s Hot in FDA Regulatory Matters"
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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 October 2024 Issue of the Month Investigating Pesticide Tolerance By Dr. Bill Reeves, EAS Consulting Group Regulatory Consultant Consistent, scientifically justified regulations enable over $1.5 trillion in global agricultural exports every year. The world economy depends on these regulations to ensure whatever goes onto a ship is legal to sell when it reaches port. One key requirement for agricultural commodities that have received pesticide applications is that any remaining residues are within legal limits for their destination country or region.   Pesticide tolerances (known as maximum residue levels or import tolerances in some world areas) are the maximum amount of a pesticide ingredient or metabolite that can remain on the crop at harvest when the pesticide is applied according to label instructions. A tolerance is specific to the combination of a pesticide and a crop or crop group. If pesticides are present at levels greater than their tolerance or do not have a tolerance, the crop is adulterated and cannot be sold. Read Full Article Under the Microscope Navigating Pesticide Residue Testing: MRLs, Methods, Labs, & Regulations 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.” Reviewed and Approved by Steven Rogers, Chemistry Manager, Certified Laboratories 1-Minute Summary Maximum Residue Limits (MRLs) define allowable pesticide concentrations in food, aligned with national and international safety standards. In the U.S., FDA and USDA enforce pesticide regulations in coordination with the EPA; non-compliance risks legal action and market exclusion. The USDA provides a Pesticide MRL Database to check specific pesticide limits by commodity, available online with both free and premium options. Pesticide residue testing labs use a combination of advanced techniques for comprehensive pesticide residue analysis, including GC-FPD, LC-MS/MS, and GC-MS/MS. When choosing a testing lab, it’s vital to consider ISO 17025 accreditation, expertise, technology, and customer service. Read Full Article EAS Trainings Good ANDA Submissions Webinar October 16, 2024   21 CFR Part 11 and FDA Compliance Webinar November 8, 2024   IHK Dietary Supplement Labeling Seminar (Presented in German) November 11, 12, 13, 2024   Food and Dietary Supplement Labeling Compliance Seminar December 9, 11, 13, 2024 Upcoming Tradeshows and Conferences PCPC Science Symposium and Expo Arlington, VA October 8-9, 2024 Attending   ASQ 2024 Audit Division Conference Reno, NV October 9-10, 2024 Session Speaker   FDLI Tobacco & Nicotine Products Regulation and Policy Washington, DC October 24-25, 2024 Gold Sponsor   Supply Side West Las Vegas, NV October 28 – November 1, 2024 Attending   FDLI Enforcement, Litigation and Compliance Washington, DC December 10-11, 2024 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... Read the Drug and Device Corner on the EAS Website What’s New on the FDA Website FDA and USDA Regulatory Updates Important Changes to OTC Monograph Listing Marketing Categories FDA Reminds Animal and Human Food Facilities to Register or Review their Food Facility Registration (FFR) between October 1 and December 31, 2024 Importing FDA-Regulated Seafood Products – New FDA Video Now Available New FDA CTP Webinar: Preparing and Submitting a Standalone Pre-Existing Tobacco Product Submission FDA Guidance Document: CVM GFI #294 - Animal Food Ingredient Consultation (AFIC) FY2025 Drug Program User Fees FY2025 Medical Device Fees 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! EAS’ John Bailey to Speak at Naturally Kiawah Symposium EAS independent consultant John Bailey will speak at the Naturally Kiawah Symposium happening October 8-11, 2024, in Kiawah Island, SC, on regulation updates, MoCRA, product testing, PFAS, and more. Visit https://www.scconline.org/CarolinaSCC/Naturally-Kiawah for more information.  EAS to Present Session at ASQ 30th Anniversary Audit Division Conference EAS Senior Director Lisa El-Shall will speak on “OTCs: Cosmetic Audits” at the 2024 ASQ Audit Division Conference happening October 9-10, 2024, in Reno, NV, presented by the American Society of Quality. Visit ASQ.org to learn more: https://asq.org/conferences/audit-division Complimentary Webinar: Good ANDA Submissions Sign up today for our complimentary webinar on Good ANDA Submission Practices on October 16, 2024, from 1-2pm ET. Learn best practices for Abbreviated New Drug Application submissions with EAS consultant and former FDA drug reviewer Radhika Rajagopalan, Ph.D., where she’ll discuss the recent guidance documents, distill what FDA is really looking for, and how to best apply their principles to your submissions. Register Today! FDLI Tobacco & Nicotine Products Conference EAS is a proud Gold Sponsor of FDLI’s Tobacco and Nicotine Products Regulation and Policy Conference happening October 24-25, 2024, in Washington, DC. Complimentary Webinar: 21 CFR Part 11 and FDA Compliance Sign up today for our complimentary webinar on Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance on November 8, 2024, from 1-4pm ET presented by EAS consultant Carolyn Troiano. This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. Register Today! Registration Open for Food and DS Labeling Compliance Seminar Join EAS Consulting Group for our semi-annual Food and Dietary Supplement Labeling Compliance Seminar happening December 9, 11, 13, 2024, from 11am – 5pm ET each day. 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 also learn the complex set of labeling rules and get answers to your most challenging questions. Register Today! 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 Bill Reeves EAS Consulting Group, EAS Independent Consultant Dr. Bill Reeves is a toxicologist with experience in human health and environmental risk assessment. After earning his Ph.D. from Texas A&M University, Bill worked for California EPA establishing new water quality standards and conducting technical reviews of wastewater discharge permits. He later joined Tetra Tech, Inc., working on projects related to risk assessment and drinking water quality for the US Air Force. Most recently, Bill was with Monsanto/Bayer Crop Science’s Regulatory Sciences organization. As part of the Regulatory Affairs team, he obtained approvals for GM crops such as drought tolerant corn. For the last several years, Bill was part of the company’s Issues Management team with a focus on pesticides and human safety, including Proposition 65 and product liability litigation. Learn more about working with EAS Respected  •  Experts  •  Ethical  •  with Integrity EAS Consulting Group, 1700 Diagonal Road, Suite 750, Alexandria, VA 22314, USA, (571) 447-5500 Manage preferences |
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