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The Updated US OSHA Hazard Communication Standard
Did you know that compliance with new regulations requires updates to all your Safety Data Sheets?
On May 20, 2024, the U.S. Occupational Safety and Health Administration (OSHA) issued a final rule amending the Hazard Communication Standard (HCS) to align with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), primarily adopting Revision 7 (Rev 7). This update addresses issues from the 2012 HCS update, improves alignment with U.S. agencies and international partners, and enhances the standard's effectiveness. The amendments include:
The final rule becomes effective on July 19, 2024, with certain provisions retroactively approved as of July 15, 2019. However, the date for chemical manufacturers, importers, and distributors to comply with new SDS and labeling provisions is January 19, 2026, for substances and July 19, 2027, for mixtures. Additionally, employers must update workplace labeling, hazard communication programs, and employee training by July 20, 2026, for substances and January 19, 2028, for mixtures. Key labeling, communication, and training changes include:
Notably, the final rule allows electronic transmission of labels for bulk shipments with the receiving party's agreement and clarifies requirements for hazard classification and labeling under normal conditions of use.
Appendices A through D of the HCS have also been updated to reflect the latest scientific principles and international standards, including new hazard classes like desensitized explosives and revised criteria for health hazards such as respiratory tract corrosion. OSHA's updates aim to align the HCS with global standards, thereby reducing compliance burdens for U.S. stakeholders who must adhere to international regulations.
The new HazCom final rule is less impactful than the 2012 rule that first aligned HazCom with the GHS, focusing on a few chemical hazard classes and specific details related to chemical classification and SDS information. Many manufacturers will need to reclassify products, resulting in new SDSs and container labels.
SafeBridge offers comprehensive hazard communication and SDS support to meet these regulatory changes for chemical, pharmaceutical, food and beverage ingredient, biotech, oil, gas and refinery and general industry clients across the U.S. Additionally, SafeBridge can provide global compliance analysis or authoring of your SDSs in any of these markets.
Please contact Amanda Tuesdale at [email protected] for additional information on our HazCom and SDS services.
Tracey A. Kimmel Scholarship Winner
Congratulations to the Tracey A. Kimmel Scholarship winner, Tiago Marques Pedro. Tiago is currently a Ph.D. student at Cambridge University, and?was awarded the scholarship to attend our Potent Compound Safety Boot Camp in Cambridge, United Kingdom.
The TAK Scholarship honors Dr Tracy A. Kimmel, DABT, a valued SafeBridge colleague and exceptional toxicologist who unexpectedly passed in October 2021. The TAK Scholarship facilitates the training of exceptional graduate students and/or postdocs interested in developing skills in pharmaceutical risk assessment, by attending a Potent Compound Safety “Boot Camp”?.
If you're interested in learning more about the TAK Scholarship opportunity to attend one of our Potent Compound Safety Boot Camps, please email [email protected] .
The SafeBridge industrial hygiene laboratory develops analytical methods to help our clients meet their workplace air monitoring and surface sampling requirements. We are accredited by the American Industrial Hygiene Association (AIHA) for the analysis of active pharmaceutical ingredients.?
The SafeBridge advantage is that we employ the most sensitive techniques in the industry to detect potent drugs at very low concentrations in the workplace – to quantitation limits as low as 5 picograms/filter.
For more information on the capabilities of our laboratory as well as a complete list of analytes, please contact SafeBridge at [email protected] .
We would like to acknowledge William Hawkins,BSc (Hons), MSc, CBiol, MRSB, ERT and Martin Kohan, PhD, ERT, DABT as co-authors of the paper titled "Comparison of Permitted Daily Exposure (PDE) Values for Active Pharmaceutical Ingredients (APIs) - Evidence of Robust Approach."
"Permitted Daily Exposure Limits (PDEs) are set for Active Pharmaceutical Ingredients (APIs) to control cross-contamination when manufacturing medicinal products in shared facilities. With the lack of official PDE lists for pharmaceuticals, PDEs have to be set by each company separately. Although general rules and guidelines for the setting of PDEs exist, inter-company variations in the setting of PDEs occur and are considered acceptable within a certain range. To evaluate the robustness of the PDE approach between different pharmaceutical companies, data on PDE setting of five marketed APIs (amlodipine, hydrochlorothiazide, metformin, morphine, and omeprazole) were collected and compared. Findings show that the variability between PDE values is within acceptable ranges (below 10-fold) for all compounds, with the highest difference for morphine due to different Point of Departures (PODs) and Adjustment Factors (AFs). Factors of PDE variability identified and further discussed are: (1) availability of data, (2) selection of POD, (3) assignment of AFs, (4) route-to-route extrapolation, and (5) expert judgement and differences in company policies. We conclude that the investigated PDE methods and calculations are robust and scientifically defensible. Additionally, we provide further recommendations to harmonize PDE calculation approaches across the pharmaceutical industry."
Expert Spotlight
Emily Lent, Ph.D., DABT
SafeBridge welcomes Dr. Emily Lent as Managing Toxicologist!
Emily is a Board-Certified Toxicologist with 15 years of experience. She received her MS and PhD from the University of New Hampshire investigating stressors and endocrine disruption in anurans. She was a toxicologist for the US Army Public Health Center for 14 years providing subject matter expertise on occupational and environmental toxicology. As a study director, she coordinated, implemented, and managed GLP environmental and mammalian toxicology studies in support of risk assessments of substances of military relevance as well as representing the Army in cross governmental meetings. She was most recently at Battelle, in the role of an environmental scientist providing toxicological subject matter expertise for environmental and amphibian projects. She has served as a member of ACGIH? Threshold Limit Value (TLV) Committee and the Occupational Alliance for Risk Assessment (OARS) Workplace Environmental Exposure Levels (WEELs?) Committee. In her free time, Emily enjoys hiking.
Connect with Emily Lent .
Jacob Shedd, Ph.D.
Meet our newest Industrial Hygienist, Jacob Shedd!
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Jake is an industrial hygienist with a PhD in Environmental Health Sciences from the University of Alabama at Birmingham (UAB) and BS degrees in Industrial Hygiene and Chemistry from the University of North Alabama (UNA). While at UAB, Jake held a 6-year appointment as a National Institute of Occupational Safety and Health (NIOSH) Fellow through the Deep South Center for Occupational Health and Safety. During which time, Jake instructed and facilitated graduate level courses on occupational safety and health and conducted academic research focused on developing new occupational air sampling and analysis methods for volatile organic compounds (VOCs). This research culminated in 7 peer-reviewed publications and a provisional patent for a novel, passive, air sampling device.
Including his time as a NIOSH fellow, Jake has 10 years of safety and IH experience in diverse work environments including research laboratories, agrochemical R&D, aerospace manufacturing, chemical manufacturing, and university settings. He has also had the privilege of serving the profession through years of volunteerism and various leadership roles within the American Industrial Hygiene Association (AIHA).
Jake is a self-proclaimed foodie and loves to explore new places by checking out their local food culture. He also has a passion for the musical and visual arts, having sung with various local choirs – including the Alabama Symphony Orchestra Chorus – and painting/drawing every chance he gets. When not eating, arting, or working, Jake loves to spend quiet evenings at home with his partner, Chris.
Connect with Jacob Shedd .
Matthew Meiners, CIH
Meet our newest SafeBridge staff member, Matt Meiners, CIH! We are excited to have Matt join our Business Development team, primarily working with our Lab and Industrial Hygiene Groups.
Matt is a CIH and has been working in the Industrial Hygiene Pharmaceutical industry for 30 plus years. He is a member of various AIHA committees like the Heath Care and Hazardous Drug Working Groups, Dermal and Surface sampling and Opiates. He is also a member of the ISPE Containment Steering Committee and Containment Working Group. Many of you that attend the annual Pharma Forum will recognize Matt as the MC of the event. Matt has been involved in and co-authored numerous publications like the ISPE Good Practice Guide with Robert Sussman, PhD, DABT, the pending update of the SMEPAC document and is one of the original authors of this document. He has co-authored “The surface sampling guide for USP 800” AIHA guidance document with Amy Snow, MHS, CIH, CSP, Janet Gould, PhD, DABT, CIH, Elaine Strauss, PharmD, MS, BCSCP from WorkingBuildings.
Connect with Matt Meiners .
Dylan James
We are excited to announce that Dylan James is officially a full-time SafeBridge employee!
Dylan has been working with us as a part-time Industrial Hygienist while he completed his master’s degree at the University of North Carolina's Gillings School of Global Public Health in environmental sciences and engineering.?
Connect with Dylan James .
Upcoming?Training
Can You Handle It Safely? Basic Hazard and Exposure Assessment for Assessing the Capabilities of Contract Facilities September 25, 2024 / New Brunswick, NJ
We are bringing back this 1-day course, aimed to help business development and other professionals get a better understanding of:
To be notified when registration opens, please email [email protected] or click the button below.
SafeBridge Extractables and Leachables (E&L) "Boot Camp" October 24 - 25, 2024 / New Brunswick, NJ
This brand new, 1.5-day course will provide basic to advanced-level training on the systematic and scientific approach and key concepts involved in E&L. It will include analytical testing design to meet regulatory requirements, appropriate evaluation of the data including exposure assessment, and application of health-based risk assessments for regulatory submission.
Taught by leading industry experts in E&L and health-based risk assessment, the intensive curriculum focuses on the evaluation of packaging and other materials used for container closure systems, medical devices, IV bags, tubing, and other product contact surfaces. It will also cover the development of appropriate testing programs, analytical methods used, and performing toxicological risk assessment. Case studies and problem-solving scenarios will be provided that address the multiple challenges faced by companies assessing the safety concerns of patient exposures to potential leachables. Attendees will learn the step-by-step approach required to successfully support drug Chemistry, Manufacturing and Controls (CMC) needs during R&D, scale up, and commercial manufacturing operations.
SafeBridge? Potent Compound Safety “Boot Camp” ? October 15 - 17, 2024 / Boston, MA
A SafeBridge classic! This three-day course in pharmaceutical potent compound safety is designed for EHS and related professionals who need to understand the critical concepts of evaluating and safely handling pharmaceutical compounds. It is taught by the leading industry experts in potent compound safety, The intensive curriculum focuses on evaluation of compound potency and toxicity, sampling and monitoring protocols, control technologies, and effective investigation and communication approaches. After two days of introductory information, topics will shift to case studies and problem solving to address potent compound safety issues in discovery, development, contract manufacturing, and commercialization. It leverages a systematic approach to successfully support drug R&D and manufacturing operations.
Upcoming Conferences
IFT FIRST: Annual Event and Expo
July 14 - 17, 2024 / Chicago, IL
Will you be at the IFT FIRST ?in Chicago??Olive Ngalame, PhD of SafeBridge's Regulatory Toxicology group will be there!?
The Toxicology Forum
July 15 - 17, 2024 / Pentagon City, VA
SafeBridge is sponsoring the meeting and Anne Chappelle, PhD will be attending. Schedule a time to meet with Anne at the Tox Forum .
Senior Business Development Coordinator at SafeBridge? Regulatory & Life Sciences Group
4 个月Lots of info in that bad boy