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 B to Section 5204 - Medical Surveillance Guidelines (Non-mandatory)

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Introduction
The purpose of this Appendix is to provide medical
						  information and recommendations to aid physicians and other licensed health
						  care professionals (PLHCPs) regarding compliance with the medical surveillance
						  provisions of the respirable crystalline silica standard (Section
						  5204). Appendix B is for
						  informational and guidance purposes only and none of the statements in Appendix
						  B should be construed as imposing a mandatory requirement on employers that is
						  not otherwise imposed by the standard.
Medical screening and surveillance allow for early
						  identification of exposure-related health effects in individual employee and
						  groups of employees, so that actions can be taken to both avoid further
						  exposure and prevent or address adverse health outcomes. Silica-related
						  diseases can be fatal, encompass a variety of target organs, and may have
						  public health consequences when considering the increased risk of a latent
						  tuberculosis (TB) infection becoming active. Thus, medical surveillance of
						  silica-exposed employees requires that PLHCPs have a thorough knowledge of
						  silica-related health effects.
This Appendix is divided into seven sections. Section
						  1 reviews silica-related diseases,
						  medical responses, and public health responses. Section
						  2 outlines the components of the
						  medical surveillance program for employees exposed to silica. Section
						  3 describes the roles and
						  responsibilities of the PLHCP implementing the program and of other medical
						  specialists and public health professionals. Section
						  4 provides a discussion of
						  considerations, including confidentiality. Section
						  5 provides a list of additional
						  resources and Section
						  6 lists references. Section
						  7 provides sample forms for the
						  written medical report for the employee, the written medical opinion for the
						  employer and the written authorization.
1. Recognition of Silica-Related
						  Diseases
1.1. Overview.
The term "silica"
						  refers specifically to the compound silicon dioxide (SiO2). Silica is a major
						  component of sand, rock, and mineral ores. Exposure to fine (respirable size)
						  particles of crystalline forms of silica is associated with adverse health
						  effects, such as silicosis, lung cancer, chronic obstructive pulmonary disease
						  (COPD), and activation of latent TB infections. Exposure to respirable
						  crystalline silica can occur in industry settings such as foundries, abrasive
						  blasting operations, paint manufacturing, glass and concrete product
						  manufacturing, brick making, china and pottery manufacturing, manufacturing of
						  plumbing fixtures, and many construction activities including highway repair,
						  masonry, concrete work, rock drilling, and tuck-pointing. New uses of silica
						  continue to emerge. These include countertop manufacturing, finishing, and
						  installation (Kramer
et al.
2012; OSHA 2015) and hydraulic
						  fracturing in the oil and gas industry (OSHA 2012).
Silicosis is an irreversible, often disabling, and
						  sometimes fatal fibrotic lung disease. Progression of silicosis can occur
						  despite removal from further exposure. Diagnosis of silicosis requires a
						  history of exposure to silica and radiologic findings characteristic of silica
						  exposure. Three different presentations of silicosis (chronic, accelerated, and
						  acute) have been defined. Accelerated and acute silicosis are much less common
						  than chronic silicosis. However, it is critical to recognize all cases of
						  accelerated and acute silicosis because these are life-threatening illnesses
						  and because they are caused by substantial overexposures to respirable
						  crystalline silica. Although any case of silicosis indicates a breakdown in
						  prevention, a case of acute or accelerated silicosis implies current high
						  exposure and a very marked breakdown in prevention.
In addition to silicosis, employees exposed to
						  respirable crystalline silica, especially those with accelerated or acute
						  silicosis, are at increased risks of contracting active TB and other infections
						  (ATS 1997; Rees and Murray 2007). Exposure to respirable crystalline silica
						  also increases an employee's risk of developing lung cancer, and the higher the
						  cumulative exposure, the higher the risk (Steenland
et al.
2001; Steenland and Ward 2014). Symptoms for these diseases and other
						  respirable crystalline silica-related diseases are discussed below.
1.2. Chronic Silicosis.
Chronic
						  silicosis is the most common presentation of silicosis and usually occurs after
						  at least 10 years of exposure to respirable crystalline silica. The clinical
						  presentation of chronic silicosis is:
1.2.1. Symptoms -- shortness of breath and cough,
						  although employees may not notice any symptoms early in the disease.
						  Constitutional symptoms, such as fever, loss of appetite and fatigue, may
						  indicate other diseases associated with silica exposure, such as TB infection
						  or lung cancer. Employees with these symptoms should immediately receive
						  further evaluation and treatment.
1.2.2. Physical Examination -- may be normal or
						  disclose dry rales or rhonchi on lung auscultation.
1.2.3. Spirometry -- may be normal or may show only a
						  mild restrictive or obstructive pattern.
1.2.4. Chest X-ray -- classic findings are small,
						  rounded opacities in the upper lung fields bilaterally. However, small
						  irregular opacities and opacities in other lung areas can also occur. Rarely,
						  "eggshell calcifications" in the hilar and mediastinal lymph nodes are
						  seen.
1.2.5. Clinical Course-chronic silicosis in most cases
						  is a slowly progressive disease. Under the respirable crystalline silica
						  standard, the PLHCP is to recommend that employees with a 1/0 category X-ray be
						  referred to an American Board Certified Specialist in Pulmonary Disease or
						  Occupational Medicine. The PLHCP and/or Specialist should counsel employees
						  regarding work practices and personal habits that could affect employees'
						  respiratory health.
1.3. Accelerated Silicosis.
Accelerated silicosis generally occurs within 5-10 years of exposure and
						  results from high levels of exposure to respirable crystalline silica. The
						  clinical presentation of accelerated silicosis is:
1.3.1. Symptoms -- shortness of breath, cough, and
						  sometimes sputum production. Employees with exposure to respirable crystalline
						  silica, and especially those with accelerated silicosis, are at high risk for
						  activation of TB infections, atypical mycobacterial infections, and fungal
						  superinfections. Constitutional symptoms, such as fever, weight loss,
						  hemoptysis (coughing up blood), and fatigue may herald one of these infections
						  or the onset of lung cancer.
1.3.2. Physical Examination -- rales, rhonchi, or other
						  abnormal lung findings in relation to illnesses present. Clubbing of the
						  digits, signs of heart failure, and cor pulmonale may be present in severe lung
						  disease.
1.3.3. Spirometry -- restrictive or mixed
						  restrictive/obstructive pattern.
1.3.4. Chest X-ray -- small rounded and/or irregular
						  opacities bilaterally. Large opacities and lung abscesses may indicate
						  infections, lung cancer, or progression to complicated silicosis, also termed
						  progressive massive fibrosis.
1.3.5. Clinical Course -- accelerated silicosis has a
						  rapid, severe course. Under the respirable crystalline silica standard, the
						  PLHCP can recommend referral to a Board Certified Specialist in either
						  Pulmonary Disease or Occupational Medicine, as deemed appropriate, and referral
						  to a Specialist is recommended whenever the diagnosis of accelerated silicosis
						  is being considered.
1.4. Acute Silicosis.
Acute silicosis
						  is a rare disease caused by inhalation of extremely high levels of respirable
						  crystalline silica particles. The pathology is similar to alveolar proteinosis
						  with lipoproteinaceous material accumulating in the alveoli. Acute silicosis
						  develops rapidly, often, within a few months to less than 2 years of exposure,
						  and is almost always fatal. The clinical presentation of acute silicosis is as
						  follows:
1.4.1. Symptoms -- sudden, progressive, and severe
						  shortness of breath. Constitutional symptoms are frequently present and include
						  fever, weight loss, fatigue, productive cough, hemoptysis (coughing up blood),
						  and pleuritic chest pain.
1.4.2. Physical Examination -- dyspnea at rest,
						  cyanosis, decreased breath sounds, inspiratory rales, clubbing of the digits,
						  and fever.
1.4.3. Spirometry -- restrictive or mixed
						  restrictive/obstructive pattern.
1.4.4. Chest X-ray -- diffuse haziness of the lungs
						  bilaterally early in the disease. As the disease progresses, the "ground glass"
						  appearance of interstitial fibrosis will appear.
1.4.5. Clinical Course -- employees with acute
						  silicosis are at especially high risk of TB activation, nontuberculous
						  mycobacterial infections, and fungal superinfections. Acute silicosis is
						  immediately life-threatening. The employee should be urgently referred to a
						  Board Certified Specialist in Pulmonary Disease or Occupational Medicine for
						  evaluation and treatment. Although any case of silicosis indicates a breakdown
						  in prevention, a case of acute or accelerated silicosis implies a profoundly
						  high level of silica exposure and may mean that other employees are currently
						  exposed to dangerous levels of silica.
1.5. COPD.
COPD, including chronic
						  bronchitis and emphysema, has been documented in silica-exposed employees,
						  including those who do not develop silicosis. Periodic spirometry tests are
						  performed to evaluate each employee for progressive changes consistent with the
						  development of COPD. In addition to evaluating spirometry results of individual
						  employees over time, PLHCPs may want to be aware of general trends in
						  spirometry results for groups of employees from the same workplace to identify
						  possible problems that might exist at that workplace. (
See
Section 2 of this Appendix on Medical
						  Surveillance for further discussion.) Heart disease may develop secondary to
						  lung diseases such as COPD. A recent study by Liu
et al.
2014
						  noted a significant exposure-response trend between cumulative silica exposure
						  and heart disease deaths, primarily due to pulmonary heart disease, such as cor
						  pulmonale.
1.6. Renal and Immune System.
Silica
						  exposure has been associated with several types of kidney disease, including
						  glomerulonephritis, nephrotic syndrome, and end stage renal disease requiring
						  dialysis. Silica exposure has also been associated with other autoimmune
						  conditions, including progressive systemic sclerosis, systemic lupus
						  erythematosus, and rheumatoid arthritis. Studies note an association between
						  employees with silicosis and serologic markers for autoimmune diseases,
						  including antinuclear antibodies, rheumatoid factor, and immune complexes
						  (Jalloul and Banks 2007; Shtraichman
et al.
2015).
1.7. TB and Other Infections.
Silica-exposed employees with latent TB are 3 to 30 times more likely to
						  develop active pulmonary TB infection (ATS 1997; Rees and Murray 2007).
						  Although respirable crystalline silica exposure does not cause TB infection,
						  individuals with latent TB infection are at increased risk for activation of
						  disease if they have higher levels of respirable crystalline silica exposure,
						  greater profusion of radiographic abnormalities, or a diagnosis of silicosis.
						  Demographic characteristics, such as immigration from some countries, are
						  associated with increased rates of latent TB infection. PLHCPs can review the
						  latest Centers for Disease Control and Prevention (CDC) information on TB
						  incidence rates and high risk populations online (
See
Section
						  5 of this Appendix). Additionally,
						  silica-exposed employees are at increased risk for contracting nontuberculous
						  mycobacterial infections, including
Mycobacterium
avium-intracellulare
and
Mycobacterium
						  kansaii
.
1.8. Lung Cancer.
The National
						  Toxicology Program has listed respirable crystalline silica as a known human
						  carcinogen since 2000 (NTP 2014). The International Agency for Research on
						  Cancer (2012) has also classified silica as Group 1 (carcinogenic to humans).
						  Several studies have indicated that the risk of lung cancer from exposure to
						  respirable crystalline silica and smoking is greater than additive (Brown 2009;
						  Liu
et al.
2013). Employees should be counseled on smoking
						  cessation.
2. Medical Surveillance
PLHCPs who manage silica medical surveillance programs
						  should have a thorough understanding of the many silica-related diseases and
						  health effects outlined in Section
						  1 of this Appendix. At each
						  clinical encounter, the PLHCP should consider silica-related health outcomes,
						  with particular vigilance for acute and accelerated silicosis. In this Section,
						  the required components of medical surveillance under the respirable
						  crystalline silica standard are reviewed, along with additional guidance and
						  recommendations for PLHCPs performing medical surveillance examinations for
						  silica-exposed employees.
2.1. History
2.1.1. The respirable crystalline silica standard
						  requires the following: A medical and work history, with emphasis on: Past,
						  present, and anticipated exposure to respirable crystalline silica, dust, and
						  other agents affecting the respiratory system; any history of respiratory
						  system dysfunction, including signs and symptoms of respiratory disease
						  (
e.g.
, shortness of breath, cough, wheezing); history of TB;
						  and smoking status and history.
2.1.2. Further, the employer must provide the PLHCP
						  with the following information:
2.1.2.1. A description of the employee's former,
						  current, and anticipated duties as they relate to the employee's occupational
						  exposure to respirable crystalline silica;
2.1.2.2. The employee's former, current, and
						  anticipated levels of occupational exposure to respirable crystalline
						  silica;
2.1.2.3. A description of any personal protective
						  equipment used or to be used by the employee, including when and for how long
						  the employee has used or will use that equipment; and
2.1.2.4. Information from records of employment-related
						  medical examinations previously provided to the employee and currently within
						  the control of the employer.
2.1.3. Additional guidance and recommendations: A
						  history is particularly important both in the initial evaluation and in
						  periodic examinations. Information on past and current medical conditions
						  (particularly a history of kidney disease, cardiac disease, connective tissue
						  disease, and other immune diseases), medications, hospitalizations and
						  surgeries may uncover health risks, such as immune suppression, that could put
						  an employee at increased health risk from exposure to silica. This information
						  is important when counseling the employee on risks and safe work practices
						  related to silica exposure.
2.2. Physical Examination
2.2.1. The respirable crystalline silica standard
						  requires the following: A physical examination, with special emphasis on the
						  respiratory system. The physical examination must be performed at the initial
						  examination and every three years thereafter.
2.2.2. Additional guidance and recommendations:
						  Elements of the physical examination that can assist the PHLCP include: An
						  examination of the cardiac system, an extremity examination (for clubbing,
						  cyanosis, edema, or joint abnormalities), and an examination of other pertinent
						  organ systems identified during the history.
2.3. TB Testing
2.3.1. The respirable crystalline silica standard
						  requires the following: Baseline testing for TB on initial examination.
2.3.2. Additional guidance and recommendations:
2.3.2.1. Current CDC guidelines (
See
Section 5 of this Appendix) should be
						  followed for the application and interpretation of Tuberculin skin tests (TST).
						  The interpretation and documentation of TST reactions should be performed
						  within 48 to 72 hours of administration by trained PLHCPs.
2.3.2.2. PLHCPs may use alternative TB tests, such as
						  interferon-Î³ release assays (IGRAs), if sensitivity and specificity
						  are comparable to TST (Mazurek
et al.
2010; Slater
et
						  al.
2013). PLHCPs can consult the current CDC guidelines for
						  acceptable tests for latent TB infection.
2.3.2.3. The silica standard allows the PLHCP to order
						  additional tests or test at a greater frequency than required by the standard,
						  if deemed appropriate. Therefore, PLHCPs might perform periodic
						  (
e.g.
, annual) TB testing as appropriate, based on employees'
						  risk factors. For example, according to the American Thoracic Society (ATS),
						  the diagnosis of silicosis or exposure to silica for 25 years or more are
						  indications for annual TB testing (ATS 1997). PLHCPs should consult the current
						  CDC guidance on risk factors for TB (
See
Section
						  5 of this Appendix).
2.3.2.4. Employees with positive TB tests and those
						  with indeterminate test results should be referred to the appropriate agency or
						  specialist, depending on the test results and clinical picture. Agencies, such
						  as local public health departments, or specialists, such as a pulmonary or
						  infectious disease specialist, may be the appropriate referral. Active TB is a
						  nationally notifiable disease. PLHCPs should be aware of the reporting
						  requirements for their region. All States have TB Control Offices that can be
						  contacted for further information. (
See
Section
						  5 of this Appendix for links to
						  CDC's TB resources and State TB Control Offices.)
2.3.2.5. The following public health principles are key
						  to TB control in the U.S. (ATS-CDC-IDSA 2005):
(
1
) Prompt detection and reporting of
						  persons who have contracted active TB;
(
2
) Prevention of TB spread to close
						  contacts of active TB cases;
(
3
) Prevention of active TB in people
						  with latent TB through targeted testing and treatment; and
(
4
) Identification of settings at high
						  risk for TB transmission so that appropriate infection-control measures can be
						  implemented.
2.4. Pulmonary Function Testing
2.4.1. The respirable crystalline silica standard
						  requires the following: Pulmonary function testing must be performed on the
						  initial examination and every three years thereafter. The required pulmonary
						  function test is spirometry and must include forced vital capacity (FVC),
						  forced expiratory volume in one second (FEV 1), and FEV
						  1/FVC ratio. Testing must be administered by a
						  spirometry technician with a current certificate from a National Institute for
						  Occupational Health and Safety (NIOSH)-approved spirometry course.
2.4.2. Additional guidance and recommendations:
						  Spirometry provides information about individual respiratory status and can be
						  used to track an employee's respiratory status over time or as a surveillance
						  tool to follow individual and group respiratory function. For quality results,
						  the ATS and the American College of Occupational and Environmental Medicine
						  (ACOEM) recommend use of the third National Health and Nutrition Examination
						  Survey (NHANES III) values, and ATS publishes recommendations for spirometry
						  equipment (Miller
et al.
2005; Townsend 2011; Redlich
et al.
2014). OSHA's publication,
Spirometry
Testing in Occupational Health Programs: Best Practices for
Healthcare Professionals,
provides helpful guidance (See
						  Section 5 of this Appendix). Abnormal
						  spirometry results may warrant further clinical evaluation and possible
						  recommendations for limitations on the employee's exposure to respirable
						  crystalline silica.
2.5. Chest X-ray
2.5.1. The respirable crystalline silica standard
						  requires the following: A single posteroanterior (PA) radiographic projection
						  or radiograph of the chest at full inspiration recorded on either film (no less
						  than 14 x 17 inches and no more than 16 x 17 inches) or digital radiography
						  systems. A chest X-ray must be performed on the initial examination and every
						  three years thereafter. The chest X-ray must be interpreted and classified
						  according to the International Labour Office (ILO) International Classification
						  of Radiographs of Pneumoconioses by a NIOSH-certified B Reader.
Chest radiography is necessary to diagnose silicosis,
						  monitor the progression of silicosis, and identify associated conditions such
						  as TB. If the B reading indicates small opacities in a profusion of 1/0 or
						  higher, the employee is to receive a recommendation for referral to a Board
						  Certified Specialist in Pulmonary Disease or Occupational Medicine.
2.5.2. Additional guidance and recommendations: Medical
						  imaging has largely transitioned from conventional film-based radiography to
						  digital radiography systems. The ILO Guidelines for the Classification of
						  Pneumoconioses has historically provided film-based chest radiography as a
						  referent standard for comparison to individual exams. However, in 2011, the ILO
						  revised the guidelines to include a digital set of referent standards that were
						  derived from the prior film-based standards. To assist in assuring that
						  digitally-acquired radiographs are at least as safe and effective as film
						  radiographs, NIOSH has prepared guidelines, based upon accepted contemporary
						  professional recommendations (
See
Section
						  5 of this Appendix). Current
						  research from Laney
et al.
2011 and Halldin
et
						  al.
2014 validate the use of the ILO digital referent images. Both
						  studies conclude that the results of pneumoconiosis classification using
						  digital references are comparable to film-based ILO classifications. Current
						  ILO guidance on radiography for pneumoconioses and B-reading should be reviewed
						  by the PLHCP periodically, as needed, on the ILO or NIOSH Web sites
						  (
See
Section
						  5 of this Appendix).
2.6. Other Testing.
Under the
						  respirable crystalline silica standards, the PLHCP has the option of ordering
						  additional testing he or she deems appropriate. Additional tests can be ordered
						  on a case-by-case basis depending on individual signs or symptoms and clinical
						  judgment. For example, if an employee reports a history of abnormal kidney
						  function tests, the PLHCP may want to order a baseline renal function tests
						  (
e.g.
, serum creatinine and urinalysis). As indicated above,
						  the PLHCP may order annual TB testing for silica-exposed employees who are at
						  high risk of developing active TB infections. Additional tests that PLHCPs may
						  order based on findings of medical examinations include, but is not limited to,
						  chest computerized tomography (CT) scan for lung cancer or COPD, testing for
						  immunologic diseases, and cardiac testing for pulmonary-related heart disease,
						  such as cor pulmonale.
3. Roles and Responsibilities
3.1. PLHCP.
The PLHCP designation
						  refers to "an individual whose legally permitted scope of practice
						  (
i.e.
, license, registration, or certification) allows him or
						  her to independently provide or be delegated the responsibility to provide some
						  or all of the particular health care services required" by the respirable
						  crystalline silica standard. The legally permitted scope of practice for the
						  PLHCP is determined by each State. PLHCPs who perform clinical services for a
						  silica medical surveillance program should have a thorough knowledge of
						  respirable crystalline silica-related diseases and symptoms. Suspected cases of
						  silicosis, advanced COPD, or other respiratory conditions causing impairment
						  should be promptly referred to a Board Certified Specialist in Pulmonary
						  Disease or Occupational Medicine.
Once the medical surveillance examination is completed,
						  the employer must ensure that the PLHCP explains to the employee the results of
						  the medical examination and provides the employee with a written medical report
						  within 30 days of the examination. The written medical report must contain a
						  statement indicating the results of the medical examination, including any
						  medical condition(s) that would place the employee at increased risk of
						  material impairment to health from exposure to respirable crystalline silica
						  and any medical conditions that require further evaluation or treatment. In
						  addition, the PLHCP's written medical report must include any recommended
						  limitations on the employee's use of respirators, any recommended limitations
						  on the employee's exposure to respirable crystalline silica, and a statement
						  that the employee should be examined by a Board Certified Specialist in
						  Pulmonary Disease or Occupational medicine if the chest X-ray is classified as
						  1/0 or higher by the B Reader, or if referral to a Specialist is otherwise
						  deemed appropriate by the PLHCP.
The PLHCP should discuss all findings and test results
						  and any recommendations regarding the employee's health, worksite safety and
						  health practices, and medical referrals for further evaluation, if indicated.
						  In addition, it is suggested that the PLHCP offer to provide the employee with
						  a complete copy of their examination and test results, as some employees may
						  want this information for their own records or to provide to their personal
						  physician or a future PLHCP. Employees are entitled to access their medical
						  records.
Under the respirable crystalline silica standard, the
						  employer must ensure that the PLHCP provides the employer with a written
						  medical opinion within 30 days of the employee examination, and that the
						  employee also gets a copy of the written medical opinion for the employer
						  within 30 days. The PLHCP may choose to directly provide the employee a copy of
						  the written medical opinion. This can be particularly helpful to employees,
						  such as construction employees, who may change employers frequently. The
						  written medical opinion can be used by the employee as proof of up-to-date
						  medical surveillance. The following lists the elements of the written medical
						  report for the employee and written medical opinion for the employer. (Sample
						  forms for the written medical report for the employee, the written medical
						  opinion for the employer, and the written authorization are provided in Section
						  7 of this Appendix.)
3.1.1. The written medical report for the employee must
						  include the following information:
3.1.1.1. A statement indicating the results of the
						  medical examination, including any medical condition(s) that would place the
						  employee at increased risk of material impairment to health from exposure to
						  respirable crystalline silica and any medical conditions that require further
						  evaluation or treatment;
3.1.1.2. Any recommended limitations upon the
						  employee's use of a respirator;
3.1.1.3. Any recommended limitations on the employee's
						  exposure to respirable crystalline silica; and
3.1.1.4. A statement that the employee should be
						  examined by a Board Certified Specialist in Pulmonary Disease or Occupational
						  Medicine, where the standard requires or where the PLHCP has determined such a
						  referral is necessary. The standard requires referral to a Board Certified
						  Specialist in Pulmonary Disease or Occupational Medicine for a chest X-ray B
						  reading indicating small opacities in a profusion of 1/0 or higher, or if the
						  PHLCP determines that referral to a Specialist is necessary for other
						  silica-related findings.
3.1.2. The PLHCP's written medical opinion for the
						  employer must include only the following information:
3.1.2.1. The date of the examination;
3.1.2.2. A statement that the examination has met the
						  requirements of this section; and
3.1.2.3. Any recommended limitations on the employee's
						  use of respirators.
3.1.2.4. If the employee provides the PLHCP with
						  written authorization, the written opinion for the employer shall also contain
						  either or both of the following:
(1)
Any recommended limitations on the
						  employee's exposure to respirable crystalline silica; and
(2)
A statement that the employee
						  should be examined by a Board Certified Specialist in Pulmonary Disease or
						  Occupational Medicine if the chest X-ray provided in accordance with this
						  section is classified as 1/0 or higher by the B Reader, or if referral to a
						  Specialist is otherwise deemed appropriate.
3.1.2.5. In addition to the above referral for abnormal
						  chest X-ray, the PLHCP may refer an employee to a Board Certified Specialist in
						  Pulmonary Disease or Occupational Medicine for other findings of concern during
						  the medical surveillance examination if these findings are potentially related
						  to silica exposure.
3.1.2.6. Although the respirable crystalline silica
						  standard requires the employer to ensure that the PLHCP explains the results of
						  the medical examination to the employee, the standard does not mandate how this
						  should be done. The written medical opinion for the employer could contain a
						  statement that the PLHCP has explained the results of the medical examination
						  to the employee.
3.2. Medical Specialists.
The silica
						  standard requires that all employees with chest X-ray B readings of 1/0 or
						  higher be referred to a Board Certified Specialist in Pulmonary Disease or
						  Occupational Medicine. If the employee has given written authorization for the
						  employer to be informed, then the employer shall make available a medical
						  examination by a Specialist within 30 days after receiving the PLHCP's written
						  medical opinion.
3.2.1. The employer must provide the following
						  information to the Board Certified Specialist in Pulmonary Disease or
						  Occupational Medicine:
3.2.1.1. A description of the employee's former,
						  current, and anticipated duties as they relate to the employee's occupational
						  exposure to respirable crystalline silica;
3.2.1.2. The employee's former, current, and
						  anticipated levels of occupational exposure to respirable crystalline
						  silica;
3.2.1.3. A description of any personal protective
						  equipment used or to be used by the employee, including when and for how long
						  the employee has used or will use that equipment; and
3.2.1.4. Information from records of employment-related
						  medical examinations previously provided to the employee and currently within
						  the control of the employer.
3.2.2. The PLHCP should make certain that, with written
						  authorization from the employee, the Board Certified Specialist in Pulmonary
						  Disease or Occupational Medicine has any other pertinent medical and
						  occupational information necessary for the specialist's evaluation of the
						  employee's condition.
3.2.3. Once the Board Certified Specialist in Pulmonary
						  Disease or Occupational Medicine has evaluated the employee, the employer must
						  ensure that the Specialist explains to the employee the results of the medical
						  examination and provides the employee with a written medical report within 30
						  days of the examination. The employer must also ensure that the Specialist
						  provides the employer with a written medical opinion within 30 days of the
						  employee examination. (Sample forms for the written medical report for the
						  employee, the written medical opinion for the employer and the written
						  authorization are provided in Section
						  7 of this Appendix.)
3.2.4. The Specialist's written medical report for the
						  employee must include the following information:
3.2.4.1. A statement indicating the results of the
						  medical examination, including any medical condition(s) that would place the
						  employee at increased risk of material impairment to health from exposure to
						  respirable crystalline silica and any medical conditions that require further
						  evaluation or treatment;
3.2.4.2. Any recommended limitations upon the
						  employee's use of a respirator; and
3.2.4.3. Any recommended limitations on the employee's
						  exposure to respirable crystalline silica.
3.2.5. The Specialist's written medical opinion for the
						  employer must include the following information:
3.2.5.1. The date of the examination; and
3.2.5.2. Any recommended limitations on the employee's
						  use of respirators.
3.2.5.3. If the employee provides the Board Certified
						  Specialist in Pulmonary Disease or Occupational Medicine with written
						  authorization, the written medical opinion for the employer shall also contain
						  any recommended limitations on the employee's exposure to respirable
						  crystalline silica.
3.2.5.4. Although the respirable crystalline silica
						  standard requires the employer to ensure that the Board Certified Specialist in
						  Pulmonary Disease or Occupational Medicine explains the results of the medical
						  examination to the employee, the standard does not mandate how this should be
						  done. The written medical opinion for the employer could contain a statement
						  that the Specialist has explained the results of the medical examination to the
						  employee.
3.2.6. After evaluating the employee, the Board
						  Certified Specialist in Pulmonary Disease or Occupational Medicine should
						  provide feedback to the PLHCP as appropriate, depending on the reason for the
						  referral. OSHA believes that because the PLHCP has the primary relationship
						  with the employer and employee, the Specialist may want to communicate his or
						  her findings to the PLHCP and have the PLHCP simply update the original medical
						  report for the employee and medical opinion for the employer. This is permitted
						  under the standard, so long as all requirements and time deadlines are
						  met.
3.3. Public Health Professionals.
PLHCPs might refer employees or consult with public health professionals as a
						  result of silica medical surveillance. For instance, if individual cases of
						  active TB are identified, public health professionals from state or local
						  health departments may assist in diagnosis and treatment of individual cases
						  and may evaluate other potentially affected persons, including coworkers.
						  Because silica-exposed employees are at increased risk of progression from
						  latent to active TB, treatment of latent infection is recommended. The
						  diagnosis of active TB, acute or accelerated silicosis, or other silica-related
						  diseases and infections should serve as sentinel events suggesting high levels
						  of exposure to silica and may require consultation with the appropriate public
						  health agencies to investigate potentially similarly exposed coworkers to
						  assess for disease clusters. These agencies include local or state health
						  departments or OSHA. In addition, NIOSH can provide assistance upon request
						  through their Health Hazard Evaluation program. (
See
Section
						  5 of this Appendix)
4. Confidentiality and Other
						  Considerations
The information that is provided from the PLHCP to the
						  employee and employer under the medical surveillance section of OSHA's
						  respirable crystalline silica standard differs from that of medical
						  surveillance requirements in previous OSHA standards. The standard requires two
						  separate written communications, a written medical report for the employee and
						  a written medical opinion for the employer. The confidentiality requirements
						  for the written medical opinion are more stringent than in past standards. For
						  example, the information the PLHCP can (and must) include in his or her written
						  medical opinion for the employer is limited to: The date of the examination, a
						  statement that the examination has met the requirements of this section, and
						  any recommended limitations on the employee's use of respirators. If the
						  employee provides written authorization for the disclosure of any limitations
						  on the employee's exposure to respirable crystalline silica, then the PLHCP can
						  (and must) include that information in the written medical opinion for the
						  employer as well. Likewise, with the employee's written authorization, the
						  PLHCP can (and must) disclose the PLHCP's referral recommendation (if any) as
						  part of the written medical opinion for the employer. However, the opinion to
						  the employer must not include information regarding recommended limitations on
						  the employee's exposure to respirable crystalline silica or any referral
						  recommendations without the employee's written authorization.
The standard also places limitations on the information
						  that the Board Certified Specialist in Pulmonary Disease or Occupational
						  Medicine can provide to the employer without the employee's written
						  authorization. The Specialist's written medical opinion for the employer, like
						  the PLHCP's opinion, is limited to (and must contain): The date of the
						  examination and any recommended limitations on the employee's use of
						  respirators. If the employee provides written authorization, the written
						  medical opinion can (and must) also contain any limitations on the employee's
						  exposure to respirable crystalline silica.
The PLHCP should discuss the implication of signing or
						  not signing the authorization with the employee (in a manner and language that
						  he or she understands) so that the employee can make an informed decision
						  regarding the written authorization and its consequences. The discussion should
						  include the risk of ongoing silica exposure, personal risk factors, risk of
						  disease progression, and possible health and economic consequences. For
						  instance, written authorization is required for a PLHCP to advise an employer
						  that an employee should be referred to a Board Certified Specialist in
						  Pulmonary Disease or Occupational Medicine for evaluation of an abnormal chest
						  X-ray (B-reading 1/0 or greater). If an employee does not sign an
						  authorization, then the employer will not know and cannot facilitate the
						  referral to a Specialist and is not required to pay for the Specialist's
						  examination. In the rare case where an employee is diagnosed with acute or
						  accelerated silicosis, co-workers are likely to be at significant risk of
						  developing those diseases as a result of inadequate controls in the workplace.
						  In this case, the PLHCP and/or Specialist should explain this concern to the
						  affected employee and make a determined effort to obtain written authorization
						  from the employee so that the PLHCP and/or Specialist can contact the
						  employer.
Finally, without written authorization from the
						  employee, the PLHCP and/or Board Certified Specialist in Pulmonary Disease or
						  Occupational Medicine cannot provide feedback to an employer regarding control
						  of workplace silica exposure, at least in relation to an individual employee.
						  However, the regulation does not prohibit a PLHCP and/or Specialist from
						  providing an employer with general recommendations regarding exposure controls
						  and prevention programs in relation to silica exposure and silica-related
						  illnesses, based on the information that the PLHCP receives from the employer
						  such as employees' duties and exposure levels. Recommendations may include
						  increased frequency of medical surveillance examinations, additional medical
						  surveillance components, engineering and work practice controls, exposure
						  monitoring and personal protective equipment. For instance, more frequent
						  medical surveillance examinations may be a recommendation to employers for
						  employees who do abrasive blasting with silica because of the high exposures
						  associated with that operation.
ACOEM's Code of Ethics and discussion is a good
						  resource to guide PLHCPs regarding the issues discussed in this section
						  (
See
Section
						  5 of this Appendix).
5. Resources
5.1. American College of Occupational and Environmental
						  Medicine (ACOEM):
ACOEM Code of Ethics. Accessed at:
http://www.acoem.org/codeofconduct.aspx
Raymond, L.W. and Wintermeyer, S. (2006) ACOEM
						  evidenced-based statement on medical surveillance of silica-exposed workers:
						  Medical surveillance of workers exposed to crystalline silica.
J Occup
						  Environ Med,
48, 95-101.
5.2. Center for Disease Control and Prevention
						  (CDC)
Tuberculosis Web page:
http://www.cdc.gov/tb/default.htm
State TB Control Offices Web page:
http://www.cdc.gov/tb/links/tboffices.htm
Tuberculosis Laws and Policies Web page:
http://www.cdc.gov/tb/programs/laws/default.htm
CDC. (2013). Latent Tuberculosis Infection: A Guide for
						  Primary Health Care Providers. Accessed at:
http://www.cdc.gov/tb/publications/ltbi/pdf/targetedltbi.pdf
5.3. International Labour Organization
International Labour Office (ILO). (2011) Guidelines
						  for the use of the ILO International Classification of Radiographs of
						  Pneumoconioses, Revised edition 2011. Occupational Safety and Health Series No.
						  22:
http://www.ilo.org/safework/info/publications/WCMS_168260/lang-en/index.htm
5.4. National Institute of Occupational Safety and
						  Health (NIOSH)
NIOSH B Reader Program Web page. (Information on
						  interpretation of X-rays for silicosis and a list of certified B-readers).
						  Accessed at:
http://www.cdc.gov/niosh/topics/chestradiography/breader-info.html
NIOSH Guideline (2011). Application of Digital
						  Radiography for the Detection and Classification of Pneumoconiosis. NIOSH
						  publication number 2011-198. Accessed at:
http://www.cdc.gov/niosh/docs/2011-198/.
NIOSH Hazard Review (2002), Health Effects of
						  Occupational Exposure to Respirable Crystalline Silica. NIOSH publication
						  number 2002-129: Accessed at
http://www.cdc.gov/niosh/docs/2002-129/
NIOSH Health Hazard Evaluations Programs. (Information
						  on the NIOSH Health Hazard Evaluation (HHE) program, how to request an HHE and
						  how to look up an HHE report). Accessed at:
http://www.cdc.gov/niosh/hhe/
5.5. National Industrial Sand Association:
Occupational Health Program for Exposure to Crystalline
						  Silica in the Industrial Sand Industry. National Industrial Sand Association,
						  2nd ed. 2010. Can be ordered at:
http://www.sand.org/silica-occupational-health-program
5.6. Occupational Safety and Health Administration
						  (OSHA)
Contacting OSHA:
http://www.osha.gov/html/Feed_Back.html
OSHA's Clinicians Web page. (OSHA resources,
						  regulations and links to help clinicians navigate OSHA's Web site and aid
						  clinicians in caring for workers.) Accessed at:
http://www.osha.gov/dts/oom/clinicians/index.html
OSHA's Safety and Health Topics Web page on Silica.
						  Accessed at:
http://www.osha.gov/dsg/topics/silicacrystalline/index.html
OSHA (2013). Spirometry Testing in Occupational Health
						  Programs: Best Practices for Healthcare Professionals. (OSHA 3637-03 2013).
						  Accessed at:
http://www.osha.gov/Publications/OSHA3637.pdf
OSHA/NIOSH (2011). Spirometry: OSHA/NIOSH Spirometry
						  InfoSheet (OSHA 3415-1-11). (Provides guidance to employers). Accessed at
http://www.osha.gov/Publications/osha3415.pdf
OSHA/NIOSH (2011) Spirometry: OSHA/NIOSH Spirometry
						  Worker Info. (OSHA 3418-3-11). Accessed at
http://www.osha.gov/
						  Publications/osha3418.pdf
5.7. Other
Steenland, K. and Ward E. (2014). Silica: A lung
						  carcinogen.
CA Cancer J Clin,
64, 63-69. (This article reviews
						  not only silica and lung cancer but also all the known silica-related health
						  effects. Further, the authors provide guidance to clinicians on medical
						  surveillance of silica-exposed workers and worker counselling on safety
						  practices to minimize silica exposure.)
6. References
American Thoracic Society (ATS). Medical Section of the
						  American Lung Association (1997). Adverse effects of crystalline silica
						  exposure.
Am J Respir Crit Care Med,
155, 761-765.
American Thoracic Society (ATS), Centers for Disease
						  Control (CDC), Infectious Diseases Society of America (IDSA) (2005).
						  Controlling Tuberculosis in the United States.
Morbidity and Mortality
						  Weekly Report (MMWR),
54(RR12), 1-81. Accessed at:
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5412a1.htm
.
Brown, T. (2009). Silica exposure, smoking, silicosis
						  and lung cancer--complex interactions.
Occupational Medicine,
59, 89-95.
Halldin, C.N., Petsonk, E.L., and Laney, A.S. (2014).
						  Validation of the International Labour Office digitized standard images for
						  recognition and classification of radiographs of pneumoconiosis.
Acad
						  Radiol,
21, 305-311.
International Agency for Research on Cancer. (2012).
						  Monographs on the evaluation of carcinogenic risks to humans: Arsenic, Metals,
						  Fibers, and Dusts Silica Dust, Crystalline, in the Form of Quartz or
						  Cristobalite. A Review of Human Carcinogens. Volume 100 C. Geneva, Switzerland:
						  World Health Organization.
Jalloul, A.S. and Banks D.E. (2007). Chapter 23. The
						  health effects of silica exposure. In: Rom, W.N. and Markowitz, S.B. (Eds).
						  Environmental and Occupational Medicine, 4th edition. Lippincott, Williams and
						  Wilkins, Philadelphia, 365-387.
Kramer, M.R., Blanc, P.D., Fireman, E., Amital, A.,
						  Guber, A., Rahman, N.A., and Shitrit, D. (2012). Artifical stone silicosis:
						  Disease resurgence among artificial stone workers.
Chest,
142,
						  419-424.
Laney, A.S., Petsonk, E.L., and Attfield, M.D. (2011).
						  Intramodality and intermodality comparisons of storage phosphor computed
						  radiography and conventional film-screen radiography in the recognition of
						  small pneumonconiotic opacities.
Chest,
140, 1574-1580.
Liu, Y., Steenland, K., Rong, Y., Hnizdo, E., Huang,
						  X., Zhang, H., Shi, T., Sun, Y., Wu, T., and Chen, W. (2013). Exposure-response
						  analysis and risk assessment for lung cancer in relationship to silica
						  exposure: A 44-year cohort study of 34,018 workers.
Am J Epi,
178, 1424-1433.
Liu, Y., Rong, Y., Steenland, K., Christiani, D.C.,
						  Huang, X., Wu, T., and Chen, W. (2014). Long-term exposure to crystalline
						  silica and risk of heart disease mortality.
Epidemiology,
25,
						  689-696.
Mazurek, G.H., Jereb, J., Vernon, A., LoBue, P.,
						  Goldberg, S., Castro, K. (2010). Updated guidelines for using interferon gamma
						  release assays to detect Mycobacterium tuberculosis infection--United States.
Morbidity and Mortality Weekly Report (MMWR),
59(RR05),
						  1-25.
Miller, M.R., Hankinson, J., Brusasco, V., Burgos, F.,
						  Casaburi, R., Coates, A., Crapo, R., Enright, P., van der Grinten, C.P.,
						  Gustafsson, P., Jensen, R., Johnson, D.C., MacIntyre, N., McKay, R., Navajas,
						  D., Pedersen, O.F., Pellegrino, R., Viegi, G., and Wanger, J. (2005).
American Thoracic Society/European Respiratory Society
						  (ATS/ERS) Task Force: Standardisation of Spirometry.
Eur Respir
						  J,
26, 319-338.
National Toxicology Program (NTP) (2014). Report on
						  Carcinogens, Thirteenth Edition. Silica, Crystalline (respirable Size).
						  Research Triangle Park, NC: U.S. Department of Health and Human Services,
						  Public Health Service.
http://ntp.niehs.nih.gov/ntp/roc/content/profiles/sili-ca.pdf
.
Occupational Safety and Health Administration/National
						  Institute for Occupational Safety and Health (OSHA/NIOSH) (2012). Hazard Alert.
						  Worker exposure to silica during hydraulic fracturing.
Occupational Safety and Health Administration/National
						  Institute for Occupational Safety and Health (OSHA/NIOSH) (2015). Hazard alert.
						  Worker exposure to silica during countertop manufacturing, finishing, and
						  installation. (OSHA-HA-3768-2015).
Redlich, C.A., Tarlo, S.M., Hankinson, J.L., Townsend,
						  M.C, Eschenbacher, W.L., Von Essen, S.G., Sigsgaard, T., Weissman, D.N. (2014).
						  Official American Thoracic Society technical standards: Spirometry in the
						  occupational setting.
Am J Respir Crit Care Med
; 189,
						  984-994.
Rees, D. and Murray, J. (2007). Silica, silicosis and
						  tuberculosis.
Int J Tuberc Lung Dis
, 11(5), 474-484.
Shtraichman, O., Blanc, P.D., Ollech, J.E., Fridel, L.,
						  Fuks, L., Fireman, E., and Kramer, M.R. (2015). Outbreak of autoimmune disease
						  in silicosis linked to artificial stone.
Occup Med,
65,
						  444-450.
Slater, M.L., Welland, G., Pai, M., Parsonnet, J., and
						  Banaei, N. (2013). Challenges with QuantiFERON-TB gold assay for large-scale,
						  routine screening of U.S. healthcare workers.
Am J Respir Crit Care
						  Med,
188, 1005-1010.
Steenland, K., Mannetje, A., Boffetta, P., Stayner, L.,
						  Attfield, M., Chen, J., Dosemeci, M., DeKlerk, N., Hnizdo, E., Koskela, R., and
						  Checkoway, H. (2001). International Agency for Research on Cancer. Pooled
						  exposure-response analyses and risk assessment for lung cancer in 10 cohorts of
						  silica-exposed workers: An IARC multicentre study.
Cancer Causes
						  Control,
12(9):773-84.
Steenland, K. and Ward E. (2014). Silica: A lung
						  carcinogen.
CA Cancer J Clin,
64, 63-69.
Townsend, M.C. ACOEM Guidance Statement. (2011).
						  Spirometry in the occupational health setting-2011 Update.
J Occup
						  Environ Med,
53, 569-584.
7. Sample Forms
Three sample forms are provided. The first is a sample
						  written medical report for the employee. The second is a sample written medical
						  opinion for the employer. And the third is a sample written authorization form
						  that employees sign to clarify what information the employee is authorizing to
						  be released to the employer.
Click
						  here to view image
Click
						  here to view image
Click
						  here to view image
1. New
						  Appendix B filed 10-17-2016; operative 10-17-2016 pursuant to Labor Code
						  section
						  142.3.
						  Submitted to OAL for filing and printing only pursuant to Labor Code section
						  142.3(a)(3)
						  (Register 2016, No. 43).
2. Editorial correction of paragraph
						  2.3.2.2. (Register 2016, No. 46).
Note: Authority cited: Sections
							 142.3,
							 9020,
							 9030 and
							 9040, Labor
							 Code. Reference: Sections
							 142.3,
							 9004(d),
							 9009,
							 9020,
							 9031 and
							 9040, Labor
							 Code.