Secretary of Defense

The toxicological profiles are developed in response to the Superfund Amendments and Reauthorization Act (SARA) of 1986 (Public Law 99-499) which amended the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or Superfund). Section 211 of SARA also amended Title 10 of the U. S. Code, creating the Defense Environmental Restoration Program. Section 2704(a) of Title 10 of the U. S. Code directs the Secretary of Defense to notify the Secretary of Health and Human Services of not less than 25 of the most commonly found unregulated hazardous substances at defense facilities. Section 2704(b) of Title 10 of the U. S. Code directs the Administrator of the Agency for Toxic Substances and Disease Registry (ATSDR) to prepare a toxicological profile for each substance on the list provided by the Secretary of Defense under subsection (b). 

The Department of Defense Authorization Act of 1986 (Public Law 99-145) directed the Secretary of Defense to destroy all lethal unitary chemical munitions and agents by September 30, 1994, including organophosphate nerve agents such as GB. The act was amended in 1988 (Public Law 100-456) to allow for complete disposal of chemical munitions by April 1997. 

Etter, DeLores M. (Deputy Under Secretary of Defense, Science and Technology), letter to Clinton... 

Rising concern over the deterioration of these munitions in storage and the related safety and environmental risks, led to Public Law 99-145, which directs the Secretary of Defense to carry... 

The purpose of the EDS phase is threefold (1) to support the development of a request for proposal (RFP) for a full-scale facility (2) to support the certification decision of the Under Secretary of Defense for Acquisition and Technology, as directed by Public Law 105-261 and (3) to support documentation required for the National Environmental Policy Act (NEPA) and the data required for a permit under the Resource Conservation and Recovery Act (RCRA). Each EDS comprises two parts an EDP and engineering tests and studies to generate required data that were not obtained during the earlier demonstration test phase. 

The present report is the committee s response to the third and final task in its overall statement of task. The report will be produced in time to contribute to the record of decision (ROD) by the Office of the Secretary of Defense on the selection of a technology for the Blue Grass site.3... 

In due eourse, the AP sent a letter to the Director of the Medical Laboratories, quoting my invitation, and requesting permission to visit. Unfortunately, Secretary of Defense Laird had just plaeed an embargo on all media visits to our facility. Sensing a ground swell of anti-Chemieal Corps sentiment, the Administration had invoked the elassified shibboleth, hoping to minimize publicity. 

The Secretary of Defense also responded to the Council s recommendations by issuing a Top Secret memo along similar lines to the service secretaries (Army, Navy, Air Force and Marines). He specified that each secretary must approve any protocol originating in his branch of service, name the person in charge and inform the Secretary of Defense of each approval. 

The Commander of the Chemical Corps Research and Engineering Command, die Chief Chemical Officer, and the Surgeon General forwarded a plan developed by die Chemical Corps, listing seven investi tive studies in progress. After its approval, ftiey downgraded the original Secretary of Defense s memorandum to Confidential. ... 

The review process went all the way up to the Secretary of Defense, and included experiments conducted by contractors. This meant that studies with volunteer subjects at many prestigious universities throughout the country would need approval in writing by the Secretary of the Army. It is uncertain whether this actually took place. 

FOBS (Fractional Orbital Aerospace Bomhard-ment System). A statement by Secretary of Defense, Robert S. McNamara, to the press on 3 November 1967 acknowledging (he development by the Soviets of a FOBS. McNamara... 

The research described in this report was sponsored hy the Office of the Secretary of Defense (OSD). The research was conducted jointly hy RAND Health s Center for Military Health Policy Research and the Forces and Resources Policy Center of the National Defense Research Institute, a federally funded research and development center supported hy the OSD, the Joint Staff, the unified commands, and the defense agencies under Contract DASWOl-Of-C-0004. 

This report was prepared for the Deputy Assistant to the Secretary of Defense for Chemical and Biological Defense. The purpose of study was to address organizational, educational, and training issues for... 

OSD authority would best be vested in the DATSD(CBD) for determining when and how DoD interacts with FDA for all CBW drugs and vaccines. Centralization of OSD authority for FDA relations is intended to clarify who speaks to FDA, who speaks for the Secretary of Defense, and who answers to Congress on issues of CBW defense. It need not preclude delegation of authority for specific drugs or biologies. 

In DoD, Anna Johnson-Winegar, Deputy Assistant Secretary of Defense for Chemical and Biological Defense, requested the study and provided important guidance at critical points. In her office, Robert Borowski provided sustained counsel throughout the study. The DoD interviewees included a number of military and civilian officials, most active and some retired. Our debt to them is substantial. 

Although there are broader policy issues related to the acquisition of drugs and biologies for CBW defense than those examined in this report, this report is limited to the important but often overlooked issue of DoD-FDA interactions. RAND undertook this study for the Office of the Deputy Assistant to the Secretary of Defense for Chemical and Biological Defense (DATSD[CBD]). Our purposes were (1) to examine the interactions between DoD and FDA as they affect the development and acquisition of drugs and biologies for CBW defense and (2) to identify potential improvements in those interactions as they affect future CBW defense needs. 

Our initial expectations were that we would interview far more FDA officials than we did. However, we ended up interviewing more DoD officials, at all levels of policy and operations. Officials were interviewed in the following DoD offices Anthrax Vaccine Immunization Program (AVIP) J-4 Eogistics Directorate Office of the ASD(HA) JPO-BD the Defense Supply Center in Philadelphia Office of the Assistant to the Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs U.S. Army Soldier Biological and Chemical Command U.S. Army Medical Materiel Development Activity and U.S. Army Medical Research Institute of Infectious Diseases... 

In December 1997, Secretary of Defense William Cohen announced a departmentwide anthrax immunization program for high-risk military personnel. Implementation began in March 1998. On May 18, 1998, the Secretary authorized the vaccination of all military forces (Cohen, 1998). Almost 2.5 million troop-equivalent doses of vaccine were required to implement the Secretary s decision, much more than had ever been produced by the licensed manufacturer in its entire history. Prior to Desert Storm, the primary vaccine users had been veterinary, laboratory, and industrial workers at risk of infection, for whom an estimated 60,000 doses of Anthrax Vaccine Absorbed (AVA) were distributed between 1974 and 1989, an average of 4,533 doses per year (foellenbeck et al., 2002). During Desert Storm, approximately 150,000 troops received 300,000 doses of AVA, without accurate recording of recipients or adverse reactions. 

Third, rather than having a coordinated approach to FDA, DoD sent many representatives to meetings between FDA and BioPort. OSD was been represented by the Office of the Assistant to the Secretary of Defense for Nuclear, Chemical, and Biological Warfare the... 

The industrial model of vaccine development is best described in a report requested by Congress and the Deputy Secretary of Defense. The study, which was asked to report on the acquisition of biological warfare defenses, drew heavily on the views of the expert panel that conducted it. The report argued that (1) threats of biological warfare and endemic infectious disease are high consequence (2) vaccines are the lowest-risk, most-effective response to these threats ... 

The Report to the Deputy Secretary of Defense by the Independent Panel of Experts, Vol. P proposed the following elements as needed and feasible in a DoD vaccine development and acquisition strategy (DoD, 2000, p.ii) ... 

Casciotti, John, LL.B., Office of the General Counsel, Office of the Secretary of Defense, June 1, 2001. 

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