Author Archives: Sylvie Blondelle

National Inventory for Poliovirus Containment Survey

With the assistance of the NIH Office of Science Policy, the U.S. National Authority for Containment of Poliovirus (U.S. NAC) has contacted all registered Institutional Biosafety Committee Chairs and/or Co-Chairs to request their assistance in sharing information about the recently launched National Inventory for Poliovirus Containment (NIPC). The Chairs/Co-Chairs were asked to forward information about the national inventory online survey to principal investigators. This survey is being conducted to 1) identify facilities in the United States that possess any materials that could potentially contain poliovirus and 2) collect laboratory inventory data of materials potentially containing poliovirus.

Poliovirus containment is a key objective of World Health Organization (WHO)’s Global Polio Eradication Initiative and Global Action Plan (GAPIII). Per GAPIII, each country is required to complete a national inventory of poliovirus-containing materials. The NIPC was launched because of guidance issued by WHO on the handling of poliovirus potentially infectious materials (PIM), material collected in a time and place where wild poliovirus (WPV) circulated or oral poliovirus vaccine (OPV) was in use.

Investigators are being asked to complete the survey if their laboratory tests, extracts, handles, or stores biological samples from humans, experimentally infected animals, sewage, or environmental waters. The survey questions are intended to identify laboratories that possess any materials that could potentially contain poliovirus, and it is important to note that potentially infectious materials are identified on the basis of where and when the samples were collected, not on the basis of any test results. Additional information about the survey can be found on the U.S. NAC’s website at https://www.cdc.gov/cpr/polioviruscontainment/NIPC.htm.

NIH Guidelines Revision

the NIH posted the finalized proposal to amend the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to streamline the oversight of gene therapy research. This proposal, which was developed in conjunction with the Food and Drug Administration, included amending the NIH Guidelines to eliminate duplicative review and reporting requirements for human gene transfer protocols and refocuses the role of the NIH Recombinant DNA Advisory Committee (RAC) as a transparent forum for science, safety, and ethics of emerging biotechnologies. The RAC has been renamed the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC).

The roles and responsibilities of IBCs to review gene therapy protocols have been modified so that they are consistent with the review of other research covered under the NIH Guidelines. Gene therapy protocols remain subject to Food and Drug Administration (FDA) and other clinical trial regulations, and only after FDA, IBC, IRB, and other relevant approvals are in place can these protocols proceed.

2019 BioNet Symposium – Feedback

The annual BioNet Symposium was successfully held on April 19, 2019 at San Diego State University. This year’s program covered Zika virus effects in brains, Project Management strategies, ABSA current role and effort to promote biosafety worldwide, biosecurity and biosafety risks associated with synthetic biology, biosafety considerations when administrating viral vector or human pathogens in rodent, challenges when handling coxsackie B virus, and tips on how to approach investigators initiating new projects.

The Committee would like to thank BioRaft for sponsoring the symposium and the exhibitors (Applied Instruments, Berlin Packaging, Corporate Environmental Advisors, and Technical Safety Services Inc.) for their support.

Attendees also enjoyed a day of networking, and raffle prizes and afterwards gathering at a nearby brewery. We hope to see you all at the next BioNet event!

2019 BioNet Annual Symposium

Registration is open! Please go to the event page to register.

We have secured a location for our 2019 Symposium.  This event will be held at San Diego State University Tula Community Center on April 19, 2019.  The BioNet Symposium Committee has been in contact with several exciting speakers and with the location and date now confirmed we can move forward to secure speaker commitments.  A flyer with updated presentation specifics will follow soon.

Please save April 19, 2019 and join us for the BioNet Symposium!

2019 Membership Registration Open

The membership Registration for 2019 is now open at the low cost of $40. If you are a member, renewal must be done by January 31, 2019 to avoid losing your privileges as a member, such as access to the member only webpages, discount for the BioNet annual meeting and free lunch at the quarterly BioNet meetings. If you are not a member, this is the best time to join and enjoy the member benefits!

To renew your membership, do not log in as member but
1. Click on “Become a Member”,
2. Click on Renew membership – “click here
3. Enter your information: Name and method of payment
4. Click on sent. A message “Your message was sent successfully. Thanks” will appear on your screen.
5. Choose your method of payment. If paying with PayPal, click on “Buy Now”, if paying by check or money order, please send it at the address listed at the bottom of the webpage. Please note that credit card payments can only be done via a PayPal account, not by using your credit card directly.

Green Acres August 2018

Summer Meeting Outcome

The summer BioNet meeting was held on Friday August 3 afternoon at Celgene Corporation with a really informative presentation on the new EPA e-manifest system by James Kaplin, ACTenviro (BioNet members may view the presentation by login on to the member pages only) and interesting short presentation on how to apply Behavioralism and Marketing to create a Biosafety Culture by Tara O’Bryan.

BioNet would like to thank Celgene Corporation for their support by cordially allowing the use of their facilities.

The afternoon lectures were followed by a wonderful and fun networking event at Green Acres.

Do not miss the last 2018 BioNet meeting scheduled on November 9 in the Orange County/Los Angeles area. Stay tune for more info!

BioNet Election – Call for Nominations

BioNet is accepting nominations for the two positions on the BioNet Board of Directors up for election:
President Elect: The term of BioNet President is 2 years and is preceded by 1 year as president elect and concludes with 1 year as past president (4 years total).  The President presides over all Board meetings, appoints committees/chairs and task forces as needed, and maintains the activities of the BioNet organization in line with current By-Laws.  Time commitment: 4-12 hours/month.

Director-at-Large:  This is a 3 year term to assist in ideas for speakers for the quarterly meetings or annual symposium, assist President with requested activities. Time commitment: 1-3 hours/month.

We hope to increase our diversity by having people join the board who have not previously been involved with the BioNet administration.  We are also hoping to recruit candidates from outside of San Diego, if possible.  Please note the nominee must be a BioNet member but not necessarily a member of ABSA .

Click here for BioNet positions description and here for the Nomination Form.

The BioNet Board of Directors meets each month via a 30 – 60 minute conference call and for 30 minutes or so before each public meeting.  There are three 2-hour luncheon meetings that include a 45 minute lecture on a topic of interest and a day-long symposium scheduled for Springtime each year. A potential board member should plan on attending most of the meetings and conference calls.  The conference calls are the first Tuesday of each month at 12PM.

The potential nominees will be reviewed by the Nominations Committee and the selected nominees will be announced at the July BioNet member meeting.  Elections will follow.

Please let us know if you would like to run or nominate someone you know would like to serve.  It is perfectly OK to nominate yourself; many do.  If you nominate a colleague, make sure that he or she is willing.

Nominations should be sent to:
David Hall
La Jolla Institute
9420 Athena Circle
La Jolla, CA 92037
davidh@lji.org

October: National Biosafety Month

NIH Office of Science Policy has announced the focus for this year’s National Biosafety Month for October 2017 “Promoting biosafety through good governance”. BioNet members are invited to share with other BioNet members using the Forum section of the members only portion of the website to post what their institutions are doing for National Biosafety Month. Please join the discussion!

You may also consult the “Guiding Principles for Biosafety Governance”, recently developed by the Federal Experts Security Advisory Panel (FESAP).  Other resources can also be found, on the S3: Science, Safety, Security website.

California Medical Waste Management Act Changes

In January 2015, the California Department of Public Health published an updated version of the Medical Waste Management Act (MWMA). Below are important changes that may affect your institution.

17630 -Biohazard Bag 
“Biohazard bag” means a disposable film bag that is impervious to moisture. The film bags that are used for transport shall be marked and certified by the manufacturer as having passed the tests prescribed for tear resistance in the American Society for Testing Materials (ASTM) D1922, “Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method” and for impact resistance in ASTM D1709, “Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method” as those documents were published on January 1, 2014. The film bag shall meet an impact resistance of 165 grams and a tearing resistance of 480 grams in both parallel and perpendicular planes with respect to the length of the bag. The color of the bag shall be red, except when yellow bags are used to further segregate trace chemotherapy waste and white bags are used to further segregate pathology waste.

118275 (a)(6)
(B) Nonradioactive pharmaceutical wastes that are not subject to the federal Resource Conservation and Recovery Act of 1976 (Public Law 94-580), as amended, and that are regulated as medical waste are placed in a container or secondary container labeled with the words “HIGH HEAT OR INCINERATION ONLY,” or with another label approved by the department, on the lid and sides, so as to be visible from any lateral direction, to ensure treatment of the biohazardous waste pursuant to Section 118222.

117665 – Highly Communicable Diseases
“Highly communicable diseases” means diseases, such as those caused by organisms classified by the federal Centers for Disease Control and Prevention as risk group 3 organisms or higher.

117750 – Sharps Container
(a) “Sharps container” means a rigid puncture-resistant container used in patient care or research activities meeting the standards of, and receiving approval from, the United States Food and Drug Administration as a medical device used for the collection of discarded medical needles or other sharps.

(b) Sharps containers, including those used to containerize trace chemotherapeutic wastes, shall not be lined with a plastic bag or inner liner.

117975 – Treatment and tracking Records
(a) A large quantity medical waste generator required to register pursuant to this chapter shall maintain for a minimum of two years individual treatment and shipping and tracking documents for all untreated medical waste shipped offsite for treatment.

117967 – Onsite Treatment (similar requirement listed in 117938 for small quantity generators)
(a) Large quantity generators that treat medical waste onsite using steam sterilization, incineration, microwave technology, or other department approved treatment technology to treat medical waste shall train the operators of the equipment in its use, proper protective equipment to wear, if necessary, and how to clean up spills to ensure that the equipment is being operated in a safe and effective manner.

(b) Annual training for the operators shall be provided after the initial training has been completed.

(c) The training shall be documented and the documentation shall be retained at the facility for a minimum of two years. Training shall comply with applicable federal Occupational Safety and Health Administration regulations, including those found in Section 1910 of Title 29 of the Code of Federal Regulations.

Please consult the CDPH website for other changes made to the MWMA.