California Code of Regulations › Title 8 - Industrial Relations › Division 1 - Department of Industrial Relations › Chapter 4 - Division of Industrial Safety › Subchapter 7 - General Industry Safety Orders › Group 16 - Control of Hazardous Substances › Article 110 - Regulated Carcinogens › Appendix C to Section 5217 - Medical Surveillance-Formaldehyde

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
I. Health Hazards
The occupational health hazards of formaldehyde are
						  primarily due to its toxic effects after inhalation, after direct contact with
						  the skin or eyes by formaldehyde in liquid or vapor form, and after
						  ingestion.
II. Toxicology
A. Acute Effects of Exposure
1. Inhalation (breathing): Formaldehyde is highly
						  irritating to the upper airways. The concentration of formaldehyde that is
						  immediately dangerous to life and health is 100 ppm. Concentrations above 50
						  ppm can cause severe pulmonary reactions within minutes. These include
						  pulmonary edema, pneumonia, and bronchial irritation which can result in death.
						  Concentrations above 5 ppm readily cause lower airway irritation characterized
						  by cough, chest tightness, and wheezing. There is some controversy regarding
						  whether formaldehyde gas is a pulmonary sensitzer which can cause occupational
						  asthma in a previously normal individual. Formaldehyde can produce symptoms of
						  bronchial asthma in humans. The mechanism may be either sensitization of the
						  individual by exposure to formaldehyde or direct irritation by formaldehyde in
						  persons with pre-existing asthma. Upper airway irritation is the most common
						  respiratory effect reported by workers and can occur over a wide range of
						  concentrations, most frequently above 1 ppm. However, airway irritation has
						  occurred in some workers with exposures to formaldehyde as low as 0.1 ppm.
						  Symptoms of upper airway irritation include dry or sore throat, itching and
						  burning sensations of the nose, and nasal congestion. Tolerance to this level
						  of exposure may develop within 1-2 hours. This tolerance can permit workers
						  remaining in an environment of gradually increasing formaldehyde concentrations
						  to be unaware of their increasingly hazardous exposure.
2. Eye contact: Concentrations of formaldehyde between
						  0.05 ppm and 0.5 ppm produce a sensation of irritation in the eyes with
						  burning, itching, redness, and tearing. Increased rate of blinking and eye
						  closure generally protects the eye from damage at these low levels, but these
						  protective mechanisms may interfere with some workers' work abilities.
						  Tolerance can occur in workers continuously exposed to concentrations of
						  formaldehyde in this range. Accidental splash injuries of human eyes to aqueous
						  solutions of formaldehyde (formalin) have resulted in a wide range of ocular
						  injuries including corneal opacities and blindness. The severity of the
						  reactions have been directly dependent on the concentration of formaldehyde in
						  solution and the amount of time lapsed before emergency and medical
						  intervention.
3. Skin contact: Exposure to formaldehyde solutions can
						  cause irritation of the skin and allergic contact dermatitis. These skin
						  diseases and disorders can occur at levels well below those encountered by many
						  formaldehyde workers. Symptoms include erythema, edema, and vesiculation or
						  hives. Exposure to liquid formalin or formaldehyde vapor can provoke skin
						  reactions in sensitized individuals even when airborne concentrations of
						  formaldehyde are well below 1 ppm.
4. Ingestion: Ingestion of as little as 30 ml of a 37
						  percent solution of formaldehyde (formalin) can result in death.
						  Gastrointestinal toxicity after ingestion is most severe in the stomach and
						  results in symptoms which can include nausea, vomiting, and severe abdominal
						  pain. Diverse damage to other organ systems including the liver, kidney,
						  spleen, pancreas, brain, and central nervous systems can occur from the acute
						  response to ingestion of formaldehyde.
B. Chronic Effects of Exposure
Long term exposure to formaldehyde has been shown to be
						  associated with an increased risk of cancer of the nose and accessory sinuses,
						  nasopharyngeal and oropharyngeal cancer, and lung cancer in humans. Animal
						  experiments provide conclusive evidence of a casual relationship between nasal
						  cancer in rats and formaldehyde exposure. Concordant evidence of
						  carcinogenicity includes DNA binding, genotoxicity in short-term tests, and
						  cytotoxic changes in the cells of the target organ suggesting both
						  preneoplastic changes and a doserate effect. Formaldehyde is a complete
						  carcinogen and appears to exert an effect on at least two stages of the
						  carcinogenic process.
III. Surveillance considerations
A. History
1. Medical and occupational history: Along with its
						  acute irritative effects, formaldehyde can cause allergic sensitization and
						  cancer. One of the goals of the work history should be to elicit information on
						  any prior or additional exposure to formaldehyde in either the occupational or
						  the non-occupational setting.
2. Respiratory history: As noted above, formaldehyde
						  has recognized properties as an airway irritant and has been reported by some
						  authors as a cause of occupational asthma. In addition, formaldehyde has been
						  associated with cancer of the entire respiratory system of humans. For these
						  reasons, it is appropriate to include a comprehensive review of the respiratory
						  system in the medical history. Components of this history might include
						  questions regarding dyspnea on exertion, shortness of breath, chronic airway
						  complaints, hyperactive airway disease, rhinitis, bronchitis, bronchiolitis,
						  asthma, emphysema, respiratory allergic reaction, or other preexisting
						  pulmonary disease.
In addition, generalized airway hypersensitivity can
						  result from exposures to a single sensitizing agent. The examiner should,
						  therefore, elicit any prior history of exposure to pulmonary irritants and any
						  short- or long-term effects of that exposure.
Smoking is known to decrease mucociliary clearance of
						  materials deposited during respiration in the nose and upper airways. This may
						  increase a worker's exposure to inhaled materials such as formaldehyde vapor.
						  In addition, smoking is a potential confounding factor in the investigation of
						  any chronic respiratory disease, including cancer. For these reasons, a
						  complete smoking history should be obtained.
3. Skin Disorders: Because of the dermal irritant and
						  sensitizing effects of formaldehyde, a history of skin disorders should be
						  obtained. Such a history might include the existence of skin irritation,
						  previously documented skin sensitivity, and other dermatologic disorders.
						  Previous exposure to formaldehyde and other dermal sensitizers should be
						  recorded.
4. History of atopic or allergic diseases: Since
						  formaldehyde can cause allergic sensitization of the skin and airways, it might
						  be useful to identify individuals with prior allergen sensitization. A history
						  of atopic disease and allergies to formaldehyde or any other substances should
						  also be obtained. It is not definitely known at this time whether atopic
						  diseases and allergies to formaldehyde or any other substances should also be
						  obtained. Also, it is not definitely known at this time whether atopic
						  individuals have a greater propensity to develop formaldehyde sensitivity than
						  the general population, but identification of these individuals may be useful
						  for ongoing surveillance.
5. Use of disease questionnaires: Comparison of the
						  results from previous years with present results provides the best method for
						  detecting a general deterioration in health when toxic signs and symptoms are
						  measured subjectively. In this way recall bias does not affect the results of
						  the analysis. Consequently, OSHA has determined that the findings of the
						  medical and work histories should be kept in a standardized form for comparison
						  of the year-to-year results.
B. Physical Examination
1. Mucosa of eyes and airways: Because of the irritant
						  effects of formaldehyde, the examining physician should be alert to evidence of
						  this irritation. A speculum examination of the nasal mucosa may be helpful in
						  assessing possible irritation and cytotoxic changes, as may be indirect
						  inspection of the posterior pharynx by mirror.
2. Pulmonary system: A conventional respiratory
						  examination, including inspection of the thorax and auscultation and percussion
						  of the lung fields should be performed as part of the periodic medical
						  examination. Although routine pulmonary function testing is only required by
						  the standard once every year for persons who are exposed over the TWA
						  concentration limit, these tests have an obvious value in investigation
						  possible respiratory dysfunction and should be used wherever deemed appropriate
						  by the physician. In cases of alleged formaldehyde-induced airway disease,
						  other possible causes of pulmonary disfunction (including exposures to other
						  substances) should be ruled out. A chest radiograph may be useful in these
						  circumstances. In cases of suspected airway hypersensitivity or allergy, it may
						  be appropriate to use bronchial challenge testing with formaldehyde or
						  methacholine to determine the nature of the disorder. Such testing should be
						  performed by or under the supervision of a physician experienced in the
						  procedures involved.
3. Skin: The physician should be alert to evidence of
						  dermal irritation of sensitization, including reddening and inflammation,
						  urticaria, blistering, scaling, formation of skin fissures, or other symptoms.
						  Since the integrity of the skin barrier is compromised by other dermal disease,
						  the presence of such disease should be noted. Skin sensitivity testing carries
						  with it some risk of inducing sensitivity, and therefore, skin testing for
						  formaldehyde sensitivity should not be used as a routine screening test.
						  Sensitivity testing may be indicated in the investigation of a suspected
						  existing sensitivity. Guidelines for such testing have been prepared by the
						  North American Contact Dermatitis Group.
C. Additional Examinations or Tests
The physician may deem it necessary to perform other
						  medical examinations or tests as indicated. The standard provides a mechanism
						  whereby these additional investigations are covered under the standard for
						  occupational exposure to formaldehyde.
D. Emergencies
The examination of workers exposed in an emergency
						  should be directed at the organ systems most likely to be affected. Much of the
						  contents of the examination will be similar to the periodic examination unless
						  the patient has received a severe acute exposure requiring immediate attention
						  to prevent serious consequences. If a severe overexposure requiring medical
						  intervention or hospitalization has occurred, the physician must be alert to
						  the possibility of delayed symptoms. Follow-up nonroutine examinations may be
						  necessary to assure the patient's well-being.
E. Employer Obligations
The employer is required to provide the physician with
						  the following information: A copy of this standard and appendices A, C, D, and
						  E; a description of the affected employee's duties as they relate to his or her
						  exposure concentration; an estimate of the employee's exposure including
						  duration (e.g. 15 hr/wk, three 8-hour shifts, full-time); a description of any
						  personal protective equipment, including respirators, used by the employee; and
						  the results of any previous medical determinations for the affected employee
						  related to formaldehyde exposure to the extent that this information is within
						  the employer's control.
F. Physician's Obligations
The standard requires the employer to obtain a written
						  statement from the physician. This statement must contain the physician's
						  opinion as to whether the employee has any medical condition which would place
						  him or her at increased risk of impaired health from exposure to formaldehyde
						  or use of respirators, as appropriate. The physician must also state his
						  opinion regarding any restrictions that should be placed on the employee's
						  exposure to formaldehyde or upon the use of protective clothing or equipment
						  such as respirators. If the employee wears a respirator as a result of his or
						  her exposure to formaldehyde, the physician's opinion must also contain
						  statement regarding the suitability of the employee to wear the type of
						  respirator assigned. Finally, the physician must inform the employer that the
						  employee has been told the results of the medical examination and of any
						  medical conditions which require further explanation or treatment. This written
						  opinion is not to contain any information on specific findings or diagnoses
						  unrelated to occupational exposure to formaldehyde.
The purpose in requiring the examining physician to
						  supply the employer with a written opinion is to provide the employer with a
						  medical basis to assist the employer in placing employees initially, in
						  assuring that their health is not being impaired by formaldehyde, and to assess
						  the employee's ability to use any required protective
						  equipment.