2021 was the quite a year for environmental, health and safety professionals. The last few month particularly have felt a bit like déjà vu. It is my fervent hope that each of you and your loved ones remain healthy.
In December, the BioPharma EHS Forum celebrated its 17th Anniversary. A few of you may recall that in December 2004, Genentech hosted the inaugural meeting of the BioPharma EHS Forum at its South San Francisco site. The vision of Debora Van der Sluis, then-Senior Manager, Research & Development, EHS, Genentech, was to provide an opportunity for EHS professionals in BioPharma companies to exchange ideas, share best practices, network, and benchmark with other companies to help improve worker safety and health. In 2009, the Forum held its first meeting in Massachusetts, at Genzyme, and videoconference was available for Western U.S. locations. To minimize disruption and extended down times to accommodate lunches, early and late hours, Forum members voted in 2015 to hold the annual in-person meeting in a single location (rather than video cast in Massachusetts and California). Gilead Sciences graciously hosted 43 participants at our last in-person annual meeting in Oceanview, CA in 2019. Due to the global pandemic, there was no in-person meeting in 2020 or 2021.
We appreciate your continued support moving forward into 2022. Heartfelt gratitude to the faithful members of the BioPharma EHS Forum Planning Committee (Elise Franklin, BMS; Joe Hess, Gilead; Leo Njongmeta, AbbVie; Mike Cakouros, and Ginena Du, AZ; Nancy Kahl, MilliporeSigma; Jeff Hoogendyk, Takeda; Lori Medeiros-Nicholson, CRL; and Randy Boles, Vertex). The Planning Committee will decide at a later date whether the annual BioPharma EHS Forum meeting will be held in 2022 as an in-person event or as a virtual conference. The following is a report on activities during the past year:
Virtual Conference Call Series – During 2021, BioPharma EHS Forum held a series of 13 Conference Calls in lieu of the in-person meeting. The calls consisted of the following:
Biden Administration USEPA: The first call in the 2021 Conference Call Series was held on 10 March 2021. The speaker presented his perspective on “What to Expect from EPA in the Biden Administration” as the former Director of USEPA Enforcement. He recommended an EHS “Thought Process” to be applied in the current political and activist environment, how to “protect the brand” and what EHS professionals need to think about moving forward.
COVID-19: View from NIOSH: On 21 April 2021, our speaker discussed the latest developments, impact of the availability of vaccines, transmission, testing, second infection risk, natural immunity, vaccines, and variants. As usual, there was an active Q&A session.
Spore-Klenz: On 18 May 2021, an EHS professional discussed his experience Assessing Exposures & Industrial Hygiene Evaluation. He discussed the effectiveness of Spore-Klenz® in comparison to other sterilants, the various forms Spore-Klenz® comes in, chronic effects of exposure, and sampling methods.
Evolution of Federal OSHA’s COVID-19 ETS: The Federal OSHA Emergency Temporary Standard (ETS) has been of interest to BioPharma members, and on 23 June 2021, we were fortunate to hear from an industry attorney on its scope, requirements, and projected timeframes. His presentation was packed with information. He also provided information on OSHA’s Updated COVID-19 Workplace Guidance, OSHA Organizational Changes, and Enforcement and Regulatory developments. As usual, there was a robust Q&A at the end of the presentation.
What to Expect from Federal OSHA in the Biden Administration: The fifth call of the series took place on 11 August 2021. We were joined by an attorney who advises employers on workplace safety and health issues involving enforcement, compliance, workplace investigations, and emergency response matters. He provided an Overview of Key Regulations, Recent Developments, and opined on what may come down the road from Federal OSHA.
Working from Home and Return to Work: Lessons Learned: When this call was scheduled for 2 September 2021, we had anticipated that employees would have been back to “in person”. Surprise! But the timing turned out to be excellent because BioPharma members were joined three EHS professionals. Each speaker described their company’s approach, including processes for returning some workers to the site; new safety measures; the importance of teamwork, collaboration and communication; lessons from remote working; and various assessments of risk and benefit of various approaches.
Virtual Training: On 22 September 2021, the co-founder of a virtual training company, gave a fascinating presentation on virtual training and how it can be applied to workplaces with less investment than most people expect.
Human and Organizational Performance (HOP): The next call was presented by a panel on 28 September 2021. They provided information on the theory as well as concrete examples of accomplishments from executing HOP as well as a discussion of the values, models, principles and methods their company has been successful in implementing it.
September 2021 Executive Order On Vaccination: The ninth Virtual Series call took place on 30 September 2021. Members were joined once again by an industry attorney who discussed Mr. Biden’s Executive Order for a “hard” vaccine mandate for federal employees and contractors and the Directive to the Federal Occupational Safety and Health Administration (Fed/OSHA) to issue a COVID-19 ETS for a “soft” vaccine mandate for private employers with over 100 employees.
CAR-T Cell Therapy: On 10 October 2021, BioPharma members were joined by two BioPharma members. One member provided an introduction to CAR-T Cell Therapy including a discussion of cancer and therapies currently available to treat it. The second member discussed the application of NIH and CDC guidelines to CAR-T and Viral Vectors and provided a biology background.
COVID-19: Current Scientific Understanding: We were joined again on 13 October by a member of NIOSH, who discussed COVID-19 and employment trends, the state of the pandemic, vaccinations, Post-Vaccination (or “breakthrough”) COVID-19 cases, boosters, and Immune Response after Infection. A lively Q&A took place after the presentation.
Historical Exposure Assessment and Control Process and Industrial Hygiene Management Software Needs: Our 12th call took place on 4 November 2021. Our speaker reviewed the historical approach to exposure assessment and control, both qualitative and quantitative methods. A review of his company’s previous industrial hygiene platform found it lacking in some important functionality. He discussed the evaluation process for comparing various IH platforms to identify the one that would best serve their needs now and in the future. He was joined by a Senior Director of EH&S in the San Francisco office.
Electronic Reporting, OSHA Log Review and Thorny Recordkeeping Issues: Our last call of the year took place on 2 December 2021 where our speaker discussed recordkeeping challenges. She discussed some of the areas of confusion in the Federal OSHA Recordkeeping and Reporting rules for Occupational Injuries and Illnesses.
In order to assure that the topics and speakers are relevant to BioPharma EHS professionals, Forum members volunteer to participate on the Planning Committee for every annual meeting as well as the quarterly conference calls. For the past 15 years, Planning Committee members worked diligently to determine topics and select and acquire speakers for the conference calls in the Virtual Event Series; this has been especially challenging in 2021 with so many demands on their time. If you would like to participate in the Planning Committee for 2022, please let me know at your earliest convenience.
More Background on the Forum – The BioPharma EHS Forum held annual meetings in 2005 (hosted by Genentech), 2006 (Amgen), 2007 (Gilead), 2008 (Genencor), 2009 (videocast-Genzyme in MA, Genentech in CA), 2010 (AstraZeneca in MA, Life Technologies in CA), 2011 (Biogen and Genentech), 2012 (Pfizer-MA and CA), 2013 (Shire- MA and CA), 2014 (Takeda and Genentech), 2015 (EMD Millipore), and without videocast in 2016 (Novartis), 2017 (Vertex), 2018 (AbbVie-Chicago), and 2019 (Gilead Sciences). In both 2021 and 2020, the BioPharma forum was held as a Virtual Event Series. The benefit for the attendees is not just in the breadth of industry representation but also in the depth of dialogue on EHS topics important to each member as well as a specific focus on biosafety. Furthermore, it is a relatively small group, providing opportunities to informally network. All topics on the agenda are relevant and of particular interest to EHS professionals in BioPharma.
In 2018, members of the BioPharma EHS Forum voted to adopt the following Statement of Purpose:
In biotechnology and biopharmaceutical industries where there is constant innovation, the BioPharma EHS Forum focuses on supporting EHS professionals, sharing best practices, networking and benchmarking to achieve excellence in EHS programs.
Based on company requests, the chair organizes conference calls for members on topics that may be of interest. One call has already been scheduled for 2022: WELL Building Standards on 13 January 2022. Please contact Elizabeth Treanor (etreanor@phylmar.com) if you have topics you would like to volunteer to speak about or have a suggested topic and/or speaker.
Benchmarking Polls – The Forum provides an easy network for members to share information with each other and to find out what other companies are doing to address particular subjects. Members pose questions by sending them to staff, questions are distributed to members, and the results are provided to those individuals who respond (with company identifiers removed). These polls have proven to be a very useful tool in information-sharing and benchmarking. In 2021 a majority of the polls were related to COVID-19 and were sent to both BioPharma and the Phylmar Regulatory Roundtable- OSH Forum (PRR), with the results being updated daily. The COVID-19 polls included the following:
- Onsite Vaccine Administration Clinics
- Vaccination Status
- Training Approaches and Platforms for COVID-19 training
- Lessons Learned in Post Pandemic Return to Work
- Mandates and Rollout
- Date of Vaccine Mandate Implementation
- Boosters
- PPE and Policies
- Tracking Vaccinations
- Company Protocols for Vaccinations
- Testing Programs
- Testing Options and Mandates
In addition, BioPharma members requested other company experiences on the following topics:
- Animal Bedding Disposal Stations
- Evaluation of Automated Pipette Tip Washers
- Defining Near Misses and Events
- EHS Tools and Next Generation
- EHSS Programs
- Handling of Occupational Exposure Limits
- Sustainable Vehicle Parking Programs
- Audit Applicability and Regulation Tracking Tools
- Screening Programs for Access to Vivarium Facilities
- Cal-EPA Notice of Compliance for Sharps 2022
- Modesty Curtains for Emergency Showers
- Lab Room Noise
- Engineering Firms for Noise Reduction in Labs
Finally, periodically, the chair distributed various Federal OSHA announcements and information that may be useful to members.
Web Sites – As requested in 2006 by the BioPharma EHS Forum, the members-only website is available to download BioPharma EHS Forum communications, polls, presentations, etc. The public-facing BioPharma EHS Forum website, was created in 2009 and continues to provide minimal details for each annual meeting. Concerns were identified several years ago about identifying individual names and the meeting locations on the website, so general information is provided on the current year’s meeting with a request that interested persons contact the chair.
Comments – This year, no comments to federal or state regulatory agencies were submitted on behalf of the BioPharma EHS Forum. Any filing of comments is a separate project, requiring additional funding from members. In 2009 and 2013, the BioPharma EHS Forum submitted comments to NIOSH on its updating of the Hazardous Drug Alert, and comments were filed on the initial notice in 2007. The major point was that bioavailability and route of exposure should be considered before designating drugs as “Hazardous Drugs.” We stated that to be meaningful to the intended audience of healthcare workers, only drugs capable of harm in workplace situations and potential route(s) of exposure should be included in the list.
It has been another great year; thank you to all the members who help make the group valuable! The annual fee was increased in 2021 to $2,250 per business unit for cash or check payments. Costs have increased significantly, particularly for the website, poll compilation, and other administrative oversight. Each member is entitled to have 10 individuals receive materials sent to the Forum.
We are currently uncertain whether there will be an in-person BioPharma EHS Forum in 2022. In the meantime, please let me know if there is anything we can do to make the BioPharma EHS Forum provide more value to you.
Thank you.
Phylmar Sacramento Office: P. O. Box 660912
Sacramento, California 95866; +1.916.425.3270
BioPharma EHS Forum (tm) 
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