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Health hazard assessment and the toxicity clearance process.

In 1981, The Army Surgeon General established the Health Hazard Assessment (HHA) Program to evaluate the potential adverse health effects on Soldier users and maintainers of operating military weapon systems. (1) In 1983, Department of Defense Directive 5000.1 (redesignated as DoDD 5000.01 (2) in 2003) directed all uniformed services to consider health hazards as an integral part of their materiel acquisition process. Also in 1983, Army Regulation 40-103 formally established the US Army Center for Health Promotion and Preventive Medicine (USACHPPM) HHA Program. The Army Surgeon General designated the USACHPPM (now the US Army Public Health Command) as the lead agent of the HHA process in 1985, with the primary goal of identifying health hazards, assigning risk, and providing recommendations to eliminate or control those health hazards associated with the life cycle management of weapons, equipment, clothing, training devices, and other materiel systems.


When health hazards are identified, estimates of health risk severity and probability are established using risk assessment codes. The risk assessment code procedure, adopted from Military Standard 882E, (4) is used to quantify health risks to military personnel who will be operating or maintaining Army systems during testing, training, or combat. The following health hazards categories are assessed by the HHA program and defined in Army Regulation 40-10 (3):
acoustic energy         shock
biological substances   temperature extremes
chemical substances     trauma
oxygen deficiency       ultrasound
radiation energy        vibration

This article focuses exclusively on toxicity clearances (TC) and the HHA process that deals with chemical substances. When a new chemical substance not previously approved for Army use is proposed for use in an item under assessment by the HHA Program, the HHA Program will normally ask the AIPH Toxicology Portfolio (TOX) to conduct a toxicity evaluation of the chemical. The toxicity evaluation leads to the development of a TC for inclusion or reference in the HHA report. When a new chemical is proposed for use not associated with a particular weapon or piece of equipment but generically throughout the Army, approval must be obtained via a TC. The Army Surgeon General's TOX Portfolio at AIPH is described in Army Regulation 40-5. (5)

A toxicity evaluation and clearance for a specific chemical or material prior to its use helps to ensure the safety of Army personnel. A TC involves a toxicity evaluation of chemicals and materials prior to the introduction into the Army supply system. In some cases, a TC given for one item with a given use scenario may not be accepted for an item with the same compound for another use scenario. The materiel developer is responsible for identifying technically feasible materials and requesting appropriate consultation from AIPH TOX Portfolio.

In order to initiate the TC, the materiel developer must provide background information concerning the product material along with the request for the TC. The information should include the scope and length of use on the commercial market, human and/or animal toxicity data, a safety data sheet,* reports of any known adverse health effects, and manufacturing use information that will help ascertain the means and magnitude of exposure to military personnel. The requirement for additional toxicity testing will vary with the intended use of the candidate item and its chemical attributes. Examples of items requiring a TC are:
solvents                    energetics
fire extinguishing agents   propellants
repellents                  pyrotechnics
fabric finishes             hydraulic fluids
refrigerants                metals/alloys
explosives                  pest control agents

Toxicity clearances are granted for specific applications, In many cases, approval for one situation may not apply for a different use if the exposure scenario has changed.

Following the TOX Portfolio review of the pertinent information, guidance is issued in the form of a TC memorandum regarding the safe use of the proposed material. It is possible that a TC may not be granted because of insufficient toxicological data. In that case, additional toxicological testing is recommended. It is also possible that additional safety and health procedures, equipment, and/or controls are recommended for the safe use of a particular material in a specific application.

The HHA Program then reviews the TC developed by the TOX Portfolio and incorporates the applicable findings into the HHA report. A risk assessment code and a mitigation strategy may be developed with a residual risk assessment code assigned by the subject matter expert assuming the mitigation strategy is applied.

A TC is an extremely valuable tool for the materiel developer to make a more-informed decision on the possible use of a chemical or material. It is important to remember that a TC is application and exposure scenario specific.

The TOX Portfolio does recommend substitute material(s) based on efficacy of a product (for example: is chemical X a better solvent than chemical Y ?) during the research, development, test and evaluation phase of acquisitions. The decision-maker at the requesting organization, with appropriate medical health and safety guidance from the AIPH, is responsible for those decisions and recommendations for a candidate substitute.

Formerly, chemicals and materials used in the development and sustainment of Army systems were addressed in military specifications and standards. As a result of the implementation of acquisition reform/streamlining throughout the Department of Defense, performance specifications, commercial item descriptions, and consensus standards are replacing military specifications and standards. Military specifications and standards that may have received an initial toxicity review upon development, and those still in effect, are reviewed periodically to evaluate newly developed toxicity information. Because numerous products and chemicals without appropriate medical and toxicological evaluation are being proposed as alternatives, the TC is an even more valuable tool for Army leadership responsible for procurement or acquisition-related decisions.

The materiel developer must contact the AIPH TOX Portfolio to request a TC on a chemical or material early in the acquisition process to avoid delays. Direct contact with TOX Portfolio to determine if a TC has been completed on a chemical/material is recommended.


Since 1981, the Army HHA Program has provided an invaluable service to capability and materiel developers by providing recommendations designed to eliminate or control health hazards associated with weapon systems and other materiel. The HHA Program has consistently strived to improve its services by providing more meaningful and efficient assistance to the acquisition community, such as incorporation of the TC process. In the uncertain fiscal times ahead, the Army HHA Program and TOX Portfolio will continue to provide valuable and cost-effective solutions to mitigate health risks associated with the use of new and improved materiel systems.


The authors thank the following individuals for their contributions to the development of this article: Dr Mark Johnson, Director of the TOX Portfolio; Dr Wilfred McCain, a Toxicologist in the TOX Portfolio; and MAJ Sang Lee, MS USA, Executive Officer of the TOX Portfolio.


(1.) Gross R, Broadwater T. Health hazard assessments. In: Deeter DP, Gaydos JC, eds. Occupational Health: The Soldier and the Industrial Base. Fort Sam Houston, TX: The Borden Institute; 1993:165-206.

(2.) Department of Defense Directive 5000.01: The Defense Acquisition System. Washington, DC: US Dept of Defense; 2003 [current as of 2007].

(3.) Army Regulation 40-10: Health Hazard Assessment Program in Support of the Army Acquisition Process. Washington, DC: US Dept of the Army; 2007.

(4.) MIL-STD-882E: Department of Defense Standard Practice-System Safety. Washington DC: US Dept of Defense; 2012.

(5.) Army Regulation 40-5: Preventive Medicine. Washington, DC: US Dept of the Army; 2007.

Mohamed R. Mughal, PhD

John Houpt

Timothy A. Kluchinsky, Jr, DrPH

* Occupational Safety and Health Administration Form 20

All authors are assigned to the Army Institute of Public Health, US Army Public Health Command, Aberdeen Proving Ground, Maryland.

Dr Mughal and Mr Houpt are Industrial Hygienists with the HHA Program.

Dr Kluchinsky is the Manager of the HHA Program.
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Author:Mughal, Mohamed R.; Houpt, John; Kluchinsky, Timothy A., Jr.
Publication:U.S. Army Medical Department Journal
Article Type:Report
Date:Jul 1, 2014
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