HazCom 1994 - Appendix A

Health Hazard Definitions (Mandatory)

Although safety hazards related to the physical characteristics of a chemical can be objectively defined in terms of testing requirements (e.g. flammability), health hazard definitions are less precise and more subjective. Health hazards may cause measurable changes in the body - such as decreased pulmonary function. These changes are generally indicated by the occurrence of signs and symptoms in the exposed employees - such as shortness of breath, a non-measurable, subjective feeling. Employees exposed to such hazards must be apprised of both the change in body function and the signs and symptoms that may occur to signal that change.

The determination of occupational health hazards is complicated by the fact that many of the effects or signs and symptoms occur commonly in non-occupationally exposed populations, so that effects of exposure are difficult to separate from normally occurring illnesses. Occasionally, a substance causes an effect that is rarely seen in the population at large, such as angiosarcomas caused by vinyl chloride exposure, thus making it easier to ascertain that the occupational exposure was the primary causative factor. More often, however, the effects are common, such as lung cancer. The situation is further complicated by the fact that most chemicals have not been adequately tested to determine their health hazard potential, and data do not exist to substantiate these effects.

There have been many attempts to categorize effects and to define them in various ways. Generally, the terms "acute" and "chronic" are used to delineate between effects on the basis of severity or duration. "Acute" effects usually occur rapidly as a result of short-term exposures, and are of short duration. "Chronic" effects generally occur as a result of long-term exposure, and are of long duration.

The acute effects referred to most frequently are those defined by the American National Standards Institute (ANSI) standard for Precautionary Labeling of Hazardous Industrial Chemicals (Z129.1-1988) - irritation, corrosivity, sensitization and lethal dose. Although these are important health effects, they do not adequately cover the considerable range of acute effects which may occur as a result of occupational exposure, such as, for example, narcosis.

Similarly, the term chronic effect is often used to cover only carcinogenicity, teratogenicity, and mutagenicity. These effects are obviously a concern in the workplace, but again, do not adequately cover the area of chronic effects, excluding, for example, blood dyscrasias (such as anemia), chronic bronchitis and liver atrophy.

The goal of defining precisely, in measurable terms, every possible health effect that may occur in the workplace as a result of chemical exposures cannot realistically be accomplished. This does not negate the need for employees to be informed of such effects and protected from them. Appendix B, which is also mandatory, outlines the principles and procedures of hazard assessment.

For purposes of this section, any chemicals which meet any of the following definitions, as determined by the criteria set forth in Appendix B are health hazards. However, this is not intended to be an exclusive categorization scheme. If there are available scientific data that involve other animal species or test methods, they must also be evaluated to determine the applicability of the HCS.

  1. "Carcinogen:" A chemical is considered to be a carcinogen if:

    (a) It has been evaluated by the International Agency for Research on Cancer (IARC), and found to be a carcinogen or potential carcinogen; or

    (b) It is listed as a carcinogen or potential carcinogen in the Annual Report on Carcinogens published by the National Toxicology Program (NTP) (latest edition); or,

    (c) It is regulated by OSHA as a carcinogen.
  2. "Corrosive:" A chemical that causes visible destruction of, or irreversible alterations in, living tissue by chemical action at the site of contact. For example, a chemical is considered to be corrosive if, when tested on the intact skin of albino rabbits by the method described by the U.S. Department of Transportation in appendix A to 49 CFR part 173, it destroys or changes irreversibly the structure of the tissue at the site of contact following an exposure period of four hours. This term shall not refer to action on inanimate surfaces.

  3. "Highly toxic:" A chemical falling within any of the following categories:

    (a) A chemical that has a median lethal dose (LD(50)) of 50 milligrams or less per kilogram of body weight when administered orally to albino rats weighing between 200 and 300 grams each.

    (b) A chemical that has a median lethal dose (LD(50)) of 200 milligrams or less per kilogram of body weight when administered by continuous contact for 24 hours (or less if death occurs within 24 hours) with the bare skin of albino rabbits weighing between two and three kilograms each.

    (c) A chemical that has a median lethal concentration (LC(50)) in air of 200 parts per million by volume or less of gas or vapor, or 2 milligrams per liter or less of mist, fume, or dust, when administered by continuous inhalation for one hour (or less if death occurs within one hour) to albino rats weighing between 200 and 300 grams each.
  4. "Irritant:" A chemical, which is not corrosive, but which causes a reversible inflammatory effect on living tissue by chemical action at the site of contact. A chemical is a skin irritant if, when tested on the intact skin of albino rabbits by the methods of 16 CFR 1500.41 for four hours exposure or by other appropriate techniques, it results in an empirical score of five or more. A chemical is an eye irritant if so determined under the procedure listed in 16 CFR 1500.42 or other appropriate techniques.

  5. "Sensitizer:" A chemical that causes a substantial proportion of exposed people or animals to develop an allergic reaction in normal tissue after repeated exposure to the chemical.

  6. "Toxic." A chemical falling within any of the following categories:

    (a) A chemical that has a median lethal dose (LD(50)) of more than 50 milligrams per kilogram but not more than 500 milligrams per kilogram of body weight when administered orally to albino rats weighing between 200 and 300 grams each.

    (b) A chemical that has a median lethal dose (LD(50)) of more than 200 milligrams per kilogram but not more than 1,000 milligrams per kilogram of body weight when administered by continuous contact for 24 hours (or less if death occurs within 24 hours) with the bare skin of albino rabbits weighing between two and three kilograms each.

    (c) A chemical that has a median lethal concentration (LC(50)) in air of more than 200 parts per million but not more than 2,000 parts per million by volume of gas or vapor, or more than two milligrams per liter but not more than 20 milligrams per liter of mist, fume, or dust, when administered by continuous inhalation for one hour (or less if death occurs within one hour) to albino rats weighing between 200 and 300 grams each.
  7. "Target organ effects."

    The following is a target organ categorization of effects which may occur, including examples of signs and symptoms and chemicals which have been found to cause such effects. These examples are presented to illustrate the range and diversity of effects and hazards found in the workplace, and the broad scope employers must consider in this area, but are not intended to be all-inclusive.

  1. Hepatotoxins: Chemicals which produce liver damage
    Signs & Symptoms: Jaundice; liver enlargement
    Chemicals: Carbon tetrachloride; nitrosamines
  2. Nephrotoxins: Chemicals which produce kidney damage
    Signs & Symptoms: Edema; proteinuria
    Chemicals: Halogenated hydrocarbons; uranium
  3. Neurotoxins: Chemicals which produce their primary toxic effects on the nervous system
    Signs & Symptoms: Narcosis; behavioral changes; decrease in motor functions
    Chemicals: Mercury; carbon disulfide
  4. Agents which act on the blood or hemato-poietic system: Decrease hemoglobin function; deprive the body tissues of oxygen
    Signs & Symptoms: Cyanosis; loss of consciousness
    Chemicals: Carbon monoxide; cyanides
  5. Agents which damage the lung: Chemicals which irritate or damage pulmonary tissue
    Signs & Symptoms: Cough; tightness in chest; shortness of breath
    Chemicals: Silica; asbestos
  6. Reproductive toxins: Chemicals which affect the reproductive capabilities including chromosomal damage (mutations) and effects on fetuses (teratogenesis)
    Signs & Symptoms: Birth defects; sterility
    Chemicals: Lead; DBCP
  7. Cutaneous hazards: Chemicals which affect the dermal layer of the body
    Signs & Symptoms: Defatting of the skin; rashes; irritation
    Chemicals: Ketones; chlorinated compounds
  8. Eye hazards: Chemicals which affect the eye or visual capacity
    Signs & Symptoms: Conjunctivitis; corneal damage
    Chemicals: Organic solvents; acids