Quick plug for Patrick Coyle who has written for us on this subject previously, but also is the 'go to' for anything on Chemical Facility Anti-Terrorism Standards (CFATS). CFATS has been the driving force behind keeping American chemical facilities safe from terrorists for nearly 20 years (more information here). Now, as Patrick mentions in depth, Congress has not extended the programme and it will come to and end, removing infrastructure that kept facilities that dealt with a wide variety of dangerous chemicals safe. It has not been replaced by anything, will save a relatively small amount of money and could easily have been saved. Patrick states that industry is trying to get the decision reversed and I am sure that the whole hazmat would back it too...
The Chemical Security Summit is coming up at the end of the month, and it is likely to be a landmark one... to learn more about CISA, CFATS and the Summit, check out last year's presentations
The Biological Security Research Centre (BSRC) at London Metropolitan University (LMU) has been awarded a £81,785 grant from the Joseph Rowntree Charitable Trust (JRCT) to help enhance biosecurity education for life scientists in the UK and around the world over the next two years through the development of an International Biological Security Education Network (INSEN).
Michelle Rodrigues has joined MRIGlobal as Vice President, Government Business Development. In this role, she will lead business development activity in the government sector for both civil health and defense clients. Rodrigues provides an executive presence for key federal government customer relationships, including the Department of Health and Human Services, Department of Agriculture, NASA, the National Science Foundation, and the Department of Defense. Based in the national capital region, she will also join MRIGlobal’s Executive Leadership Team.
“Michelle has a strong history of more than two decades building portfolios with government clients. Her experience growing effective, diverse teams of researchers and business professionals to collaboratively deliver transformative programs will help advance MRIGlobal’s work with our U.S. government partners,” said Dr. Ian M. Colrain, President & CEO, MRIGlobal. “When coupled with MRIGlobal’s decades of expertise in countering diverse threats, we are well-positioned to further address the world’s most important challenges in ensuring warfighter protection and civilian safety.”
Emergent BioSolutions Inc. announced on July 20, 2023 that the U.S. Food and Drug Administration (FDA) has approved CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV7909, for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. The efficacy of CYFENDUS™ vaccine for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.
“The approval of CYFENDUS™ vaccine is symbolic of Emergent's longstanding partnership with the U.S. government and our shared commitment to helping protect public health,” said Dr. Kelly Warfield, Emergent’s senior vice president, science and development. “The 20-year journey from early development to approval is a major milestone that attests to Emergent's scientific and technical prowess and partnering capabilities. We are grateful for the yearslong collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and early support from the Defense Advanced Research Projects Agency (DARPA) and the National Institute of Allergy and Infectious Diseases (NIAID). Congratulations to the Emergent team and all our partners for advancing this product to approval.”
“CYFENDUS™ vaccine is a component of the U.S. government’s preparedness efforts against anthrax, which remains a high-priority national security threat due to its ability to be easily disseminated, lethality, and potential for major public health impact,” said Paul Williams, Emergent’s senior vice president, products business. “The approval of the CYFENDUS™ vaccine demonstrates what effective public-private partnerships can achieve for national security. Emergent will continue to work closely with the U.S. government to transition this product to post-approval procurement while ensuring an uninterrupted supply of this important vaccine.”
CYFENDUS™ vaccine is comprised of Anthrax Vaccine Adsorbed (AVA) and an additional adjuvant. It has been demonstrated that by using an additional adjuvant, two doses administered over 14 days elicit protective levels of immune response, which can be especially important in response to a large-scale public health emergency involving anthrax. In December 2018, CYFENDUS™ vaccine was the subject of a pre-emergency use authorization package submitted to the FDA. The following year, the U.S. government began procuring this product for national preparedness efforts.
In addition to the CYFENDUS™ vaccine, Emergent’s anthrax franchise includes the BioThrax® vaccine, which will continue to serve a critical purpose, as well as two treatments, Anthrasil® [Anthrax Immune Globulin Intravenous (human)], a polyclonal antibody therapeutic, and raxibacumab, a monoclonal antibody therapeutic.
The FDA approval of CYFENDUS™ vaccine is based on data from a series of studies supported by the U.S. government and conducted by Emergent, including:
a pivotal Phase 3 clinical study that evaluated the lot consistency, immunogenicity, and safety of the vaccine following a two-dose schedule administered intramuscularly in healthy adults,
a Phase 2 study that evaluated non-interference between the vaccine and antibacterial drugs approved for post-exposure prophylaxis of anthrax disease, and
non-clinical studies that assessed protective efficacy of the vaccine against lethal challenge with anthrax spores and helped identify neutralizing antibody levels associated with protection against disease.
The Biologics License Application submission and attainment of product licensure were completed under contract number HHSO100201600030C for the advanced development and delivery of CYFENDUS™ vaccine, funded by BARDA, within the Administration for Strategic Preparedness and Response in the U.S. Department of Health and Human Services. Early-stage development funding was also provided by NIAID, part of the National Institutes of Health, and DARPA of the U.S. Department of Defense.
Avon Protection has been awarded a three-year contract, with two optional one-year extensions, by the NATO Support and Procurement Agency (NSPA) for CBRN protective boots and gloves. The framework contract will allow NATO nations and partners to place orders for Avon Protection’s EXOSKIN-B1 boots and EXOSKIN-G1 gloves.
Launched in 2022, the EXOSKIN range of boots and gloves are manufactured from Avon Protection’s proven rubber technology. The range protects operators against Chemical Warfare Agent, Toxic Industrial Chemical and biological threats.
The ambidextrous EXOSKIN-G1 glove features a rubberised outer layer textured to maintain grip in wet conditions, and an intelligent, seamless inner knitted liner that has a conductive tip on both the thumb and forefinger to enable the wearer to handle and operate electronic touch screen devices.
The EXOSKIN-B1 boot provides improved durability and agility in the field, with quick-release straps to secure the garment over standard footwear. A highly textured sole improves the wearer’s manoeuvrability in all underfoot conditions.
Designed for quick donning and doffing, the EXOSKIN range integrates with many protective suit ensembles, delivering advanced dexterity and agility in the field while maximising protection for the operator.
“This contract further underlines Avon Protection’s close partnership with NATO for the provision of CBRN protection capability. To date several nations have actively deployed the FM50 respirator under the ongoing NSPA framework contract for that system,” Steve Elwell, President, Respiratory Protection for Avon Protection, said. “With the new boots and gloves contract, all NATO nations will now have the ability to acquire our EXOSKIN products, allowing them to benefit from our wider portfolio of market-leading technologies and to keep their operators safe in the field during CBRN situations.”
Ms. Mary Ellen Callahan has been appointed as the Assistant Secretary of the Department of Homeland Security’s Countering Weapons of Mass Destruction Office (CWMD).
Since September 2021, Ms. Callahan has served as Chief of Staff to Deputy Secretary John K. Tien at the Department of Homeland Security, providing substantive policy advice to the Deputy Secretary on a wide range of domestic and international policy and operational issues. Ms. Callahan was a key interlocutor and partner to Department Agency and Office leaders, interagency partners, the NSC, and the White House. Making the announcement, Alejandro N. Mayorkas, Secretary of Homeland Security, said Ms. Callahan’s stewardship of the Department’s vital national security interests was critical to gains made in the National Operations Center, operations to counter-human smuggling, continuity of operations and government, and stemming maritime migration.
Ms. Callahan previously served in the Department as the Chief Privacy Officer and Chief Freedom of Information Act Officer from March 2009 until August 2012. In addition to her federal experience, Ms. Callahan served as Assistant General Counsel for Privacy and Cybersecurity at The Walt Disney Company and was a partner at two major international law firms.
Mayorkas also thanked Mr. Gary Rasicot for serving as the Acting Assistant Secretary for the past two years. “His steady leadership and expertise were instrumental in leading the Department through some of the toughest issues including COVID travel restrictions, protecting major events such as the Super Bowl and the Kentucky Derby, and building trust and confidence with our State, local, territorial, and tribal partners,” Mayorkas said. “Under his leadership, CWMD made significant progress with State and local partners in biosurveillance and biodefense, enhancing national security in the event of bioincidents. Mr. Rasicot’s management of the talented CWMD workforce established an enduring vision, strategy, and focus nationwide on CBRN detection, training, and resources.”
Gary Rasicot will continue his service to the Department as the U.S. Coast Guard Deputy for Personnel Readiness to the Deputy Commandant for Mission Support. In this role, Mr. Rasicot will oversee the Coast Guard’s human resources, force readiness, and Coast Guard Academy activities, and he will be instrumental in advancing the Commandant’s workforce transformation priorities.
Parsons Corporation announced yesterday that the company was awarded a task order by the Defense Threat Reduction Agency (DTRA) under the Assessments, Exercises, Modeling, and Simulation Support indefinite-delivery, indefinite-quantity multiple award task order contract. The $170 million ceiling value task order to provide continued support to the agency consists of a one-year base period and four one-year option periods under the company’s Federal Solutions segment and includes existing and new work for the company.
Under this task order, Parsons will conduct vulnerability assessments, technical support projects, design reviews, and analyses in support of Department of Defense (DOD) and DTRA efforts; task order work also includes support to DTRA’s Nuclear Enterprise Directorate operational programs.
“Parsons is a trusted partner and security solutions provider to organizations around the globe,” said Jon Moretta, president, Engineered Systems, for Parsons. “We’re proud to deliver innovative solutions that empower our customers to counter and mitigate a broad spectrum of existing and emerging vulnerabilities and threats. We look forward to bringing our expertise, experience, and resources to DTRA and to providing technology solutions and operational support that advance the DTRA mission.”
Evotec SE recently announced that the U.S. Department of Defense (“DOD”) has awarded Evotec’s Seattle-based subsidiary, Just – Evotec Biologics, Inc. a contract valued up to $ 74 m for the rapid development of monoclonal antibody (“mAb”)-based drug product prototypes targeting orthopoxviruses.
Under the contract, Just – Evotec Biologics will develop drug product prototype(s) from discovery through the execution of Phase I first-in human (“FIH”) clinical trials. Discovery activities will include both discovery of new mAbs using AI-driven de novo antibody design and evaluation of existing mAbs. To enable rapid development, Just – Evotec Biologics will further leverage its technology platform, J.DESIGN, with activities including molecular optimisation, cell line and process development, and culminating in intensified continuous manufacturing at Just – Evotec Biologics’ advanced development and manufacturing facility - J.POD Redmond, WA (USA). In addition, Evotec will leverage its pre-clinical and clinical biologics development capabilities. The rapid, cost-efficient development of mAb product protypes will yield an accelerated supply of safe and efficacious mAb medical countermeasures (“MCMs”) for use against orthopoxviruses.
Dr Linda Zuckerman, Executive Vice President Global Head Biotherapeutics at Just – Evotec Biologics commented: “It is an honor to expand our collaboration with the DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (“JPEO-CBRND”) with this second target program effort to support the DOD’s Accelerated Antibodies Program. We are pleased to bring critical capabilities in biologics development to accelerate this important program for the DOD.”
Dr Werner Lanthaler, Chief Executive Officer of Evotec, added: “We are excited to expand our work for the DOD with this second programme of strategic national importance. Just – Evotec Biologics’ integrated J.DESIGN platform is the perfect fit for the swift and cost-efficient development and production of quality medical countermeasures and we are pleased to provide the DOD with an integrated discovery, development, and manufacturing solution.”
Mr Bruce Goodwin, Joint Project Lead for CBRND Enabling Biotechnologies, added: “JPEO-CBRND-EB is pleased to work with Just – Evotec Biologics on this innovative and significant program to protect the Warfighter.”
The contract was awarded to Just – Evotec Biologics by the DOD’s JPEO-CBRND Enabling Biotechnologies, in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), through the Medical CBRN Defense Consortium, in collaboration with the U.S. Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA) within the Administration for Strategic Preparedness and Response (ASPR), through the Medical CBRN Defense Consortium (MCDC) Other Transaction Authority (OTA), under Contract number MCDC2203-001.
A first contract under the Accelerated Antibodies Program for the development of mAbs against plague was awarded to Just – Evotec Biologics in September of 2022.
The IAEA has launched a new software tool — the Mobile-Integrated Nuclear Security Network— that provides real time radiation data on operations at high-traffic areas for goods and passengers, such as seaports, land border crossings and airports, which require nuclear security measures to be in place.
The Mobile-Integrated Nuclear Security Network (M-INSN) tool enables decision-makers, to use visual real-time radiation data, to make informed decisions to protect the public in case of a potential incident involving nuclear or other radioactive material.
“The M-INSN is an excellent example of how science and technology can support countries to effectively, efficiently, and sustainably implement relevant nuclear security measures,” said Elena Buglova, Director of the IAEA Division of Nuclear Security. “It can facilitate countries, especially those which lack sustainable means, to exercise command and control over nuclear security operations.”
The key characteristics of this secure communication system are that M-INSN administrators have direct access to real-time radiation data with the exact location of the individual users such as security personnel and radiation experts who use detection equipment, and the system is vendor neutral so any equipment can be incorporated into the user country-controlled software. Equipment status is constantly monitored on command centre computers and is displayed on an interactive map. The collection and aggregation of radiation data in M-INSN provides invaluable information to those involved in overseeing most nuclear security operations.
The M-INSN tool is freely available to countries and its core software is compatible with Windows and Linux computers, using either cloud or non-cloud based-servers. To support the transmission of detector data to the M-INSN server, Front-Line Officers are equipped with smartphones that are linked by Bluetooth to their radiation detectors. A M-INSN App installed on the smartphone securely transmits the data to the user country’s server.
“M-INSN is a secure and vendor-neutral tool, which means that it is designed to work with any electronic equipment used in nuclear security operations, regardless of the manufacturer. Its features, from alarm indicators to language settings, will be completely customizable by users to meet their specific needs. Most importantly, all access and configurations of M-INSN are completely controlled by the user country,” said Charles Massey, Senior Nuclear Security Officer at the IAEA Division of Nuclear Security.
Additional features will be added to the M-INSN in the coming months. Enhancements to M-INSN include “heat mapping” functionality that will automatically monitor previously established radiation level backgrounds and alert the security officers involved about any increased levels of radiation that require further investigation. In terms of equipment range, these include incorporating backpack-based radiation detectors, radioisotope identification devices and handheld X-ray backscatter scanners, and expanding the number of personal radiation detector manufacturers currently supported.
The availability of M-INSN with the IAEA’s other tools, such as the Tool for Radiation Alarm and Commodity Evaluation (TRACE) and the Personnel Alarm Assessment Tool (PAAT), will be a part of the overall toolkit provided to countries to improve radiation detection operations in a variety of scenarios.
M-INSN’s development is supported by funding from Germany and by in-kind contribution from the United States of America.
Supporting nuclear security measures during major public events
The use of M-INSN goes beyond the support of routine radiation detection operations related to a country’s borders. M-INSN can vastly strengthen the implementation of nuclear security measures during major public events, such as popular international sporting events, to counter potential threats involving nuclear or other radioactive material. The need for early detection of threats from nuclear and other radioactive material is a crucial part of the overall preparations and event security planning activities.
As part of the IAEA’s assistance provided to countries organizing major public events, extensive training on the detection equipment and M-INSN software operation is provided to Front-Line Officers, command centre staff and other entities involved in national nuclear security arrangements.
The IAEA’s nuclear security programme involves developing scientific, technological, and engineering innovations to address current and emerging challenges and risks to nuclear security.
AirBoss Defense Group (ADG), the global leader in survivability for the assured mobility and chemical, biological, radiological, nuclear (CBRN) communities is announcing that the Defense Logistics Agency (DLA) has selected the ADG AirBoss Molded Glove (AMG) for it’s JB2GU CBRN glove program contract. This is a three (3) year contract expected to be worth up to an aggregate amount of US$18.5 million.
ADG holds the current sole source contract for this requirement and is proud to have been again selected as the supplier of choice for this critical personal protective equipment (PPE) item for American warfighters. CBRN gloves are in continuous demand by the Department of Defense and the AMG was designed to provide superior protection against CBRN threats and a wide range of toxic industrial chemicals. The glove was developed to provide optimal fit, comfort, dexterity, and tactility while fully integrating with all currently fielded CBRN suits. The AMG is the solution of choice and incumbent program glove in over forty countries, with over 6.1 million pair sold to date.
ADG has supported the CBRN and PPE needs of the Federal Government for more than two decades and continues to actively assist the Department of Defense to build a stable, secure, and resilient supply chain for high-quality PPE.
“ADG is pleased to continue providing our unique protective and survivability solutions to the Defense Logistics Agency,” said Patrick Callahan, CEO of ADG. “The AMG is a key component of CBRN protection systems procured by the Department of Defense and we look forward to providing this critical glove system now and in the future to ensure the safety of our warfighters in austere environments and challenging conditions.”
ADG is also pleased to announce that a foreign partner nation has re-selected ADG to continue supplying the Bandolier multipurpose line charge system for use across that country’s military. This order is an expansion of the customer’s ongoing program of record for the Bandolier and is expected to be valued at up to $3.8 million USD over 12-months.
The Bandolier is a lightweight and modular energetic system that can be employed across mobility, counter mobility and survivability mission profiles. The Bandolier bridges the identified capability gap between large, complex, single role explosive charges and standard bulk demolitions. Its unique modular design is light enough to be used in dismounted operations while remaining flexible enough to meet larger-scale mission requirements.
The United States of America, the last possessor State, completed the destruction of its declared chemical weapons stockpile.
The Organisation for the Prohibition of Chemical Weapons (OPCW) confirms that the last chemical weapon from the stockpiles declared by all States Parties to the Chemical Weapons Convention (CWC) was verified as destroyed. The last chemical munition of the United States of America’s declared chemical weapons stockpile was irreversibly destroyed in accordance with the CWC on Friday, 7 July 2023 at the Blue Grass Chemical Agent-Destruction Pilot Plant in Kentucky.
“I congratulate all States Parties, and the United States of America in this instance, on this major achievement for the international community. The end of destruction of all declared chemical weapons stockpiles is an important milestone for the Organisation. It is a critical step towards achieving its mission to permanently eliminate all chemical weapons,” said OPCW Director-General, Ambassador Fernando Arias.
“This represents a historic success of multilateralism in the field of disarmament, and the work of a generation of diplomats and experts over the past 26 years. Yet, more challenges lie ahead of us, which require the international community’s continued attention. Four countries have yet to join the Convention. Abandoned and old chemical weapons still need to be recovered and destroyed,” the Director-General highlighted. “Recent uses and threats of use of toxic chemicals as weapons illustrate that preventing re-emergence will remain a priority for the Organisation. Rapid developments in science and technology, new dangerous toxic chemicals, more sophisticated equipment and production methods, better means of delivery, and the interaction between chemistry, biology, and artificial intelligence, present additional factors that will put the relevance of the Chemical Weapons Convention to the test. These provide the Organisation with new and challenging tasks, and an agenda for our common work that will remain an open one.”
“The OPCW Centre for Chemistry and Technology, which started operation in May 2023, is an essential tool to enhance the Organisation’s capabilities to address these threats. The international community can count on the Secretariat’s independence, expertise and readiness to play its part,” the Director-General concluded.
Since the CWC entered into force in 1997, the OPCW has verified the destruction of 72,304.34 metric tonnes of stockpiled chemical weapons, declared by countries around the world. The OPCW will continue to monitor the closure of the last two destruction facilities at Pueblo and Blue Grass in the U.S., including the disposal of waste resulting from the destruction process.
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