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(continued)
A. High exposure to MDA can occur when transferring the substance from one container to another. Such operations should be well ventilated and good work practices must be established to avoid spills.
B. Pure MDA is a solid with a low vapor pressure. Grinding or heating operations increase the potential for exposure.
C. Store away from oxidizing materials.
D. Employers shall advise employees of all areas and operations where exposure to MDA could occur.
VII. HOUSEKEEPING AND HYGIENE FACILITIES
A. The workplace should be kept clean, orderly, and in a sanitary condition. The employer should institute a leak and spill detection program for operations involying MDA in order to detect sources of fugitive MDA emissions.
B. Adequate washing facilities with hot and cold water are to be provided and maintained in a sanitary condition. Suitable cleansing agents should also be provided to assure the effective removal of MDA from the skin.
VIII. COMMON OPERATIONS
Common operations in which exposure to MDA is likely to occur include the following: Manufacture of MDA; Manufacture of Methylene diisocyanate; Curing agent for epoxy resin structures; Wire coating operations; and filament winding.
Appendix C to Section 5200 -Medical Surveillance Guidelines for MDA
I. ROUTE OF ENTRY
Inhalation; skin absorption; ingestion. MDA can be inhaled, absorbed through the skin, or ingested.
II. TOXICOLOGY
MDA is a suspect carcinogen in humans. There are several reports of liver disease in humans and animals resulting from acute exposure to MDA. A well documented case of an acute cardiomyopathy secondary to exposure to MDA is on record. Numerous human cases of hepatitis secondary to MDA are known. Upon direct contact MDA may also cause damage to the eyes. Dermatitis and skin sensitization have been observed. Almost all forms of acute environmental hepatic injury in humans involve the hepatic parenchyma and produce hepatocellular jaundice. This agent produces intrahepatic cholestasis. The clinical picture consists of cholestatic jaundice, preceded or accompanied by abdominal pain, fever, and chills. Onset in about 60% of all observed cases is abrupt with severe abdominal pain. In about 30% of observed cases, the illness presented and evolved more slowly and less dramatically, with only slight abdominal pain. In about 10% of the cases only jaundice was evident. The cholestatic nature of the jaundice is evident in the prominence of itching, the histologic predominance of bile stasis, and portal inflammatory infiltration, accompanied by only slight parenchmal injury in most cases, and by the moderately elevated transaminase values. Acute, high doses, however, have been known to cause hepatocellular damage resulting in elevated SGPT, SGOT, alkaline phosphatase and bilirubin.
Absorption through the skin is rapid. MDA is metabolized and excreted over a 48-hour period. Direct contact may be irritating to the skin, causing dermatitis. Also MDA which is deposited on the skin is not thoroughly removed through washing.
MDA may cause bladder cancer in humans. Animal data supporting this assumption is not available nor is conclusive human data. However, human data collected on workers at a helicopter manufacturing facility where MDA is used suggests a higher incidence of bladder cancer among exposed workers.
III. SIGNS AND SYMPTOMS
Skin may become yellow from contact with MDA. Repeated or prolonged contact with MDA may result in recurring dermatitis (red- itchy, cracked skin) and eye irritation. Inhalation, ingestion or absorption through the skin at high concentrations may result in hepatitis, causing symptoms such as fever and chills, nausea and vomiting, dark urine, anorexia, rash, right upper quadrant pain and jaundice. Corneal burns may occur when MDA is splashed in the eyes.
IV. TREATMENT OF ACUTE TOXIC EFFECTS/EMERGENCY SITUATION
If MDA gets into the eyes, immediately wash eyes with large amounts of water. If MDA is splashed on the skin, immediately wash contaminated skin with mild soap or detergent. Employee should be removed from exposure and given proper medical treatment. Medical tests required under the emergency section of the medical surveillance subsection (m)(4) must be conducted.
If the chemical is swallowed do not induce vomiting but remove by gastric lavage.
Appendix D to Section 5200 -Sampling and Analytical Methods for MDA Monitoring and Measurement Procedures
Measurements taken for the purpose of determining employee exposure to MDA are best taken so that the representative average 8-hour exposure may be determined from a single 8-hour sample or two (2) 4-hour samples. Short-time interval samples (or grab samples) may also be used to determine average exposure level if a minimum of five measurements are taken in a random manner over the 8-hour work shift. Random sampling means that any portion of the work shift has the same chance of being sampled as any other. The arithmetic average of all such random samples taken on one work shift is an estimate of an employee's average level of exposure for that work shift. Air samples should be taken in the employee's breathing zone (air that would most nearly represent that inhaled by the employee).
There are a number of methods available for monitoring employee exposures to MDA. The method OSHA currently uses is included below.
The employer, however, has the obligation of selecting any monitoring method which meets the accuracy and precision requirements of the standard under his unique field conditions. The standard requires that the method of monitoring must have an accuracy, to a 95 percent confidence level, of not less than plus or minus 25 percent for the select PEL.
OSHA METHODOLOGY
Sampling Procedure. Apparatus:
Samples are collected by use of a personal sampling pump that can be calibrated within +5% of the recommended flow rate with the sampling filter in line.
Samples are collected on 37 mm Gelman type A/E glass fiber filters treated with sulfuric acid. The filters are prepared by soaking each filter with 0.5 mL of 0.26N H2S04. (0.26 N H2S04 can be prepared by diluting 1.5 mL of 36N H2504 to 200 mL with deionized water.) The filters are dried in an oven at 100 degrees C for one hour and then assembled into two-piece 37 mm polystyrene cassettes with backup pads. The cassettes are sealed with shrink bands and the ends are plugged with plastic plugs.
After sampling, the filters are carefully removed from the cassettes and individually transferred to small vials containing approximately 2 mL deionized water. The vials must be tightly sealed. The water can be added before or after the filters are transferred. The vials must be sealable and capable of holding at least 7 mL of liquid. Small glass scintillation vials with caps containing Teflon liners are recommended.
Reagents. Deionized water is needed for addition to the vials.
Sampling technique. Immediately before sampling, remove the plastic plugs from the filter cassettes. Attach the cassette to the sampling pump with flexible tubing and place the cassette in the employee's breathing zone. After sampling, seal the cassettes with plastic plugs until the filters are transferred to the vials containing deionized water. At some convenient time within 10 hours of sampling, transfer the sample filters to vials. Seal the small vials lengthwise. Submit at least one blank filter with each sample set. Blanks should be handled in the same manner as samples, but no air is drawn through them. Record sample volumes (in L of air) for each sample, along with any potential interferences.
Retention efficiency. A retention efficiency study was performed by drawing 100 L of air (80% relative humidity) at 1 L/min through sample filters that had been spiked with 0.814mg MDA. Instead of using backup pads, blank acid-treated filters were used as backups in each cassette. Upon analysis, the top filters were found to have an average of 91.8% of the spiked amount. There was no MDA found on the bottom filters, so the amount lost was probably due to the slight instability of the MDA salt.
Extraction efficiency. The average extraction efficiency for six filters spiked at the target concentration is 99.6%. The stability of extracted and derivatized samples was verified by reanalyzing the above six samples the next day using fresh standards. The average extraction efficiency for the reanalyzed samples is 98.7%.
Recommended air volume and sampling rate. The recommended air volume is 100 L. The recommended sampling rate is 1 L/min.
Interferences (sampling). MDI appears to be a positive interference. It was found that when MDI was spiked onto an acid-treated filter, the MDI converted to MDA after air was drawn through it. Suspected interferences should be reported to the laboratory with submitted samples.
Safety precautions (sampling). Attach the sampling equipment to the employees so that it will not interfere with work performance or safety. Follow all safety procedures that apply to the work area being sampled.
Analytical Procedure. Apparatus: The following are required for analysis:
A GC equipped with an electron capture detector. For this evaluation a Tracor 222 Gas Chromatograph equipped with a Nickel 63 High Temperature Electron Capture Detector and a Linearizer was used.
A GC column capable of separating the MDA derivative from the solyent and interferences. A 6 ft x 2 mm ID glass column packed with 3% OV-101 coated on 100/120 Gas Chrom Q was used in this evaluation.
An electronic integrator or some other suitable means of measuring peak areas or heights.
Small resealable vials with Teflon-lined caps capable of holding 4 mL.
A dispenser or pipet for toluene capable of delivering 2.0 mL.
Pipets (or repipets with plastic or Teflon tips) capable of delivering 1 mL for the sodium hydroxide and buffer solutions.
A repipet capable of delivering 25mL HFAA.
Syringes for preparation of standards and injection of standards and samples into a GC.
Volumetric flasks and pipets to dilute the pure MDA in preparation of standards.
Disposable pipets to transfer the toluene layers after the samples are extracted.
Reagents.
0.5 NaOH prepared from reagent grade NaOH.
Toluene, pesticide grade. Burdick and Jackson distilled in glass toluene was used.
Heptafluorobutyric acid anhydride (HFAA). HFAA from Pierce Chemical Company was used.
pH 7.0 phosphate buffer, prepared from 136 g potassium dihydrogen phosphate and 1 L deionized water. The pH is adjusted to 7.0 with saturated sodium hydroxide solution.
4,4'-Methylenedianiline (MDA), reagent grade.
Standard Preparation. Concentrated stock standards are prepared by diluting pure MDA with toluene. Analytical standards are prepared by injectingmL amounts of diluted stock standards into vials that contain 2.0 mL toluene. 25mL HFAA are added to each vial and the vials are capped and shaken for 10 seconds. After 10 min, 1 mL of buffer is added to each vial. The vials are recapped and shaken for 10 seconds. After allowing the layers to separate, aliquots of the toluene (upper) layers are removed with a syringe and analyzed by GC. Analytical standard concentrations should bracket sample concentrations. Thus, if samples fall out of the range of prepared standards, additional standards must be prepared to ascertain detector response.
Sample preparation. The sample filters are received in vials containing deionized water. 1 mL of 0.5N NaOH and 2.0 mL toluene are added to each vial. The vials are recapped and shaken for 10 min. After allowing the layers to separate, approximately 1 mL aliquots of the toluene (upper) layers are transferred to separate vials with clean disposable pipets. The toluene layers are treated and analyzed.
Analysis. GC conditions:
Zone temperatures: Column - 220 degrees C
Injector - 235 degrees C
Detector - 335 degrees C
Gas flows, Ar/CH4: Column - 28 mL/min
(95/5) Purge - 40 mL/min
Iniection volume: 5.0mL
Column: 6 ft x 1/8 in ID glass, 3%
OV-101 on 100/120 Gas
Chrom Q
Retention time of MDA
derivative: 3.5 min
Chromatogram: Peak areas or heights are mea-
sured by an integrator or other
suitable means. A calibration
curve is constructed by plotting
response (peak areas or heights)
of standard injections versus mg
of MDA per sample. Sample
concentrations must be brack-
eted by standards.
Interferences (analytical). Any compound that gives an electron capture detector response and has the same general retention time as the HFAA derivative of MDA is a potential interference. Suspected interferences reported to the laboratory with submitted samples by the industrial hygienist must be considered before samples are derivatized. GC parameters may be changed to possibly circumvent interferences. Retention time on a single column is not considered proof of chemical identity. Analyte identity should be confirmed by GC/MS if possible.
Calculations. The analyte concentration for samples is obtained from the calibration curve in terms ofmg MDA per sample. The extraction efficiency is 100%. If any MDA is found on the blank, that amount is subtracted from the sample amounts. The air concentrations are calculated using the following formulae:
<>g/m [FN3] = (mg MDA per sample)(1000)/(L of air sampled)
ppb = (<>g/m [FN3])(24.46)/(198.3) = (<>g/m [FN3])(0.1233) where 24.46 is the molar volume at 25 degrees C and 760 mm Hg
Safety Precautions (analytical) . Avoid skin contact and inhalation of all chemicals. Restrict the use of all chemicals to a fume hood if possible. Wear safety glasses and a lab coat at all times while in the lab area.
Appendix E to Section 5200 -Qualitative and Quantitative Fit Testing Procedures
[See Section 5144, Appendix A]
s 5201. 1,3-Butadiene.
(a) Scope and application.
(1) This section applies to all occupational exposures to 1,3-Butadiene (BD), Chemical Abstracts Service Registry No. 106-99-0, except as provided in subsection (a)(2).
(2) Exemptions.
(A) Except for the recordkeeping provisions in subsection (m)(1), this section does not apply to the processing, use, or handling of products containing BD or to other work operations and streams in which BD is present where objective data are reasonably relied upon that demonstrate the work operation or the product or the group of products or operations to which it belongs may not reasonably be foreseen to release BD in airborne concentrations at or above the action level or in excess of the STEL under the expected conditions of processing, use, or handling that will cause the greatest possible release or in any plausible accident.
(B) This section also does not apply to work operations, products or streams where the only exposure to BD is from liquid mixtures containing 0.1% or less of BD by volume or the vapors released from such liquids, unless objective data become available that show that airborne concentrations generated by such mixtures can exceed the action level or STEL under reasonably predictable conditions of processing, use or handling that will cause the greatest possible release.
(C) Except for labeling requirements and requirements for emergency response, this section does not apply to the storage, transportation, distribution or sale of BD or liquid mixtures in intact containers or in transportation pipelines sealed in such a manner as to fully contain BD vapors or liquid.
(3) Where products or processes containing BD are exempted under subsection (a)(2), the employer shall maintain records of the objective data supporting that exemption and the basis for the employer's reliance on the data, as provided in subsection (m)(1).
(b) Definitions: For the purpose of this section, the following definitions shall apply:
Action level means a concentration of airborne BD of 0.5 ppm calculated as an eight (8)-hour time-weighted average.
Authorized person means any person specifically designated by the employer, whose duties require entrance into a regulated area, or a person entering such an area as a designated representative of employees to exercise the right to observe monitoring and measuring procedures under subsection (d)(8), or a person designated by the Chief or NIOSH to enter a regulated area.
1,3-Butadiene means an organic compound with chemical formula CH(2)=CH-CH=CH(2) that has a molecular weight of approximately 54.15 gm/mole.
Business day means any Monday through Friday, except those days designated as federal, state, local or company specific holidays.
Chief means the Chief of the Division of Occupational Safety and Health, or designee.
Complete Blood Count (CBC) means laboratory tests performed on whole blood specimens and includes the following: White blood cell count (WBC), hematocrit (Hct), red blood cell count (RBC), hemoglobin (Hgb), differential count of white blood cells, red blood cell morphology, red blood cell indices, and platelet count.
Day means any part of a calendar day.
Emergency situation means any occurrence such as, but not limited to, equipment failure, rupture of containers, or failure of control equipment that may or does result in an uncontrolled significant release of BD.
Employee exposure means exposure of a worker to airborne concentrations of BD which would occur if the employee were not using respiratory protective equipment.
NIOSH means the Director of the National Institute for Occupational Safety and Health (NIOSH), U.S. Department of Health and Human Services, or designee.
Objective data means monitoring data, or mathematical modeling or calculations based on composition, chemical and physical properties of a material, stream or product.
Permissible Exposure Limits, PELs means either the 8 hour Time Weighted Average (8-hr TWA) exposure or the Short-Term Exposure Limit (STEL).
Physician or other licensed health care professional is 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 one or more of the specific health care services required by subsection (k).
Regulated area means any area where airborne concentrations of BD exceed or can reasonably be expected to exceed the 8-hour time weighted average (8-hr TWA) exposure of 1 ppm or the short-term exposure limit (STEL) of 5 ppm for 15 minutes.
(c) Permissible exposure limits (PELs). -
(1) Time-weighted average (TWA) limit. The employer shall ensure that no employee is exposed to an airborne concentration of BD in excess of one (1) part BD per million parts of air (ppm) measured as an eight (8)-hour time-weighted average.
(2) Short-term exposure limit (STEL). The employer shall ensure that no employee is exposed to an airborne concentration of BD in excess of five parts of BD per million parts of air (5 ppm) as determined over a sampling period of fifteen (15) minutes.
(d) Exposure monitoring -
(1) General.
(A) Determinations of employee exposure shall be made from breathing zone air samples that are representative of the 8-hour TWA and 15-minute short-term exposures of each employee.
(B) Representative 8-hour TWA employee exposure shall be determined on the basis of one or more samples representing full-shift exposure for each shift and for each job classification in each work area.
(C) Representative 15-minute short-term employee exposures shall be determined on the basis of one or more samples representing 15-minute exposures associated with operations that are most likely to produce exposures above the STEL for each shift and for each job classification in each work area.
(D) Except for the initial monitoring required under subsection (d)(2), where the employer can document that exposure levels are equivalent for similar operations on different work shifts, the employer need only determine representative employee exposure for that operation from the shift during which the highest exposure is expected.
(2) Initial monitoring.
(A) Each employer who has a workplace or work operation covered by this section, shall perform initial monitoring to determine accurately the airborne concentrations of BD to which employees may be exposed, or shall rely on objective data pursuant to subsection (a)(2)(A) to fulfiill this requirement.
(B) Where the employer has monitored within two years prior to the effective date of this section and the monitoring satisfies all other requirements of this section, the employer may rely on such earlier monitoring results to satisfy the requirements of subsection (d)(2)(A), provided that the conditions under which the initial monitoring was conducted have not changed in a manner that may result in new or additional exposures.
(3) Periodic monitoring and its frequency.
(A) If the initial monitoring required by subsection (d)(2) reveals employee exposure to be at or above the action level but at or below both the 8-hour TWA limit and the STEL, the employer shall repeat the representative monitoring required by subsection (d)(1) every twelve months.
(B) If the initial monitoring required by subsection (d)(2) reveals employee exposure to be above the 8-hour TWA limit, the employer shall repeat the representative monitoring required by subsection (d)(1)(B) at least every three months until the employer has collected two samples per quarter (each at least 7 days apart) within a two-year period, after which such monitoring must occur at least every six months.
(C) If the initial monitoring required by subsection (d)(2) reveals employee exposure to be above the STEL, the employer shall repeat the representative monitoring required by subsection (d)(1)(C) at least every three months until the employer has collected two samples per quarter (each at least 7 days apart) within a two-year period, after which such monitoring must occur at least every six months.
(D) The employer may alter the monitoring schedule from every six months to annually for any required representative monitoring for which two consecutive measurements taken at least 7 days apart indicate that employee exposure has decreased to or below the 8-hour TWA, but is at or above the action level.
(4) Termination of monitoring.
(A) If the initial monitoring required by subsection (d)(2) reveals employee exposure to be below the action level and at or below the STEL, the employer may discontinue the monitoring for employees whose exposures are represented by the initial monitoring.
(B) If the periodic monitoring required by subsection (d)(3) reveals that employee exposures, as indicated by at least two consecutive measurements taken at least 7 days apart, are below the action level and at or below the STEL, the employer may discontinue the monitoring for those employees who are represented by such monitoring.
(5) Additional monitoring.
(A) The employer shall institute the exposure monitoring required under subsection (d) whenever there has been a change in the production, process, control equipment, personnel or work practices that may result in new or additional exposures to BD or when the employer has any reason to suspect that a change may result in new or additional exposures.
(B) Whenever spills, leaks, ruptures or other breakdowns occur that may lead to employee exposure above the 8-hr TWA limit or above the STEL, the employer shall monitor [using leak source, such as direct reading instruments, area or personal monitoring], after the cleanup of the spill or repair of the leak, rupture or other breakdown, to ensure that exposures have returned to the level that existed prior to the incident.
(6) Accuracy of monitoring. Monitoring shall be accurate, at a confidence level of 95 percent, to within plus or minus 25 percent for airborne concentrations of BD at or above the 1 ppm TWA limit and to within plus or minus 35 percent for airborne concentrations of BD at or above the action level of 0.5 ppm and below the 1 ppm TWA limit.
(7) Employee notification of monitoring results.
(A) The employer shall, within 5 business days after the receipt of the results of any monitoring performed under this section, notify the affected employees of these results in writing either individually or by posting of results in an appropriate location that is accessible to affected employees.
(B) The employer shall, within 15 business days after receipt of any monitoring performed under this section indicating the 8-hour TWA or STEL has been exceeded, provide the affected employees, in writing, with information on the corrective action being taken by the employer to reduce employee exposure to or below the 8-hour TWA or STEL and the schedule for completion of this action.
(8) Observation of monitoring. -
(A) Employee observation. The employer shall provide affected employees or their designated representatives an opportunity to observe any monitoring of employee exposure to BD conducted in accordance with subsection (d).
(B) Observation procedures. When observation of the monitoring of employee exposure to BD requires entry into an area where the use of protective clothing or equipment is required, the employer shall provide the observer at no cost with protective clothing and equipment, and shall ensure that the observer uses this equipment and complies with all other applicable safety and health procedures.
(e) Regulated areas.
(1) The employer shall establish a regulated area wherever occupational exposures to airborne concentrations of BD exceed or can reasonably be expected to exceed the permissible exposure limits, either the 8-hr TWA or the STEL.
(2) Access to regulated areas shall be limited to authorized persons.
(3) Regulated areas shall be demarcated from the rest of the workplace in any manner that minimizes the number of employees exposed to BD within the regulated area.
(4) An employer at a multi-employer worksite who establishes a regulated area shall communicate the access restrictions and locations of these areas to other employers with work operations at that worksite whose employees may have access to these areas.
(f) Methods of compliance. -
(1) Engineering controls and work practices.
(A) The employer shall institute engineering controls and work practices to reduce and maintain employee exposure to or below the PELs, except to the extent that the employer can establish that these controls are not feasible or where subsection (h)(1)(A) applies.
(B) Wherever the feasible engineering controls and work practices which can be instituted are not sufficient to reduce employee exposure to or below the 8- hour TWA or STEL, the employer shall use them to reduce employee exposure to the lowest levels achievable by these controls and shall supplement them by the use of respiratory protection that complies with the requirements of subsection (h).
(2) Compliance plan.
(A) Where any exposures are over the PELs, the employer shall establish and implement a written plan to reduce employee exposure to or below the PELs primarily by means of engineering and work practice controls, as required by subsection (f)(1), and by the use of respiratory protection where required or permitted under this section. No compliance plan is required if all exposures are under the PELs.
(B) The written compliance plan shall include a schedule for the development and implementation of the engineering controls and work practice controls including periodic leak detection surveys.
(C) Copies of the compliance plan required in subsection (f)(2) shall be furnished upon request for examination and copying to the Chief, NIOSH, affected employees and designated employee representatives. Such plans shall be reviewed at least every 12 months, and shall be updated as necessary to reflect significant changes in the status of the employer's compliance program.
(D) The employer shall not implement a schedule of employee rotation as a means of compliance with the PELs.
(g) Exposure Goal Program.
(1) For those operations and job classifications where employee exposures are greater than the action level, in addition to compliance with the PELs, the employer shall have an exposure goal program that is intended to limit employee exposures to below the action level during normal operations.
(2) Written plans for the exposure goal program shall be furnished upon request for examination and copying to the Chief, NIOSH, affected employees and designated employee representatives.
(3) Such plans shall be updated as necessary to reflect significant changes in the status of the exposure goal program.
(4) Respirator use is not required in the exposure goal program.
(5) The exposure goal program shall include the following items unless the employer can demonstrate that the item is not feasible, will have no significant effect in reducing employee exposures, or is not necessary to achieve exposures below the action level:
(A) A leak prevention, detection, and repair program.
(B) A program for maintaining the effectiveness of local exhaust ventilation systems.
(C) The use of pump exposure control technology such as, but not limited to, mechanical double-sealed or seal-less pumps.
(D) Gauging devices designed to limit employee exposure, such as magnetic gauges on rail cars.
(E) Unloading devices designed to limit employee exposure, such as a vapor return system.
(F) A program to maintain BD concentration below the action level in control rooms by use of engineering controls.
(h) Respiratory protection. -
(1) General. For employees who are required to use respirators by this section, the employer must provide respirators that comply with the requirements of this subsection. Respirators must be used during:
(A) Periods necessary to install or implement feasible engineering and work practice controls;
(B) Non-routine work operations which are performed infrequently and in which exposures are limited in duration.
(C) Work operations for which feasible engineering controls and work practice controls are not yet sufficient to reduce exposures to or below the PELs;
(D) Emergencies.
(2) Respirator Program.
(A) The employer shall institute a respirator program in accordance with section 5144(b) (except (d)(1)(C), (d)(1)(C)2.a., and b.) through (m).
(B) If air-purifying respirators are used, the employer shall replace the air purifying filter element(s) according to the replacement life interval set for the class of respirator listed in Table 1 and at the beginning of each work shift.
(C) In lieu of the replacement intervals listed in Table 1, the employer may replace cartridges or canisters at 90% of the expiration of service life, provided the employer:
1. Demonstrates that employees will be adequately protected by this procedure.
2. Uses BD breakthrough data for this purpose that have been derived from tests conducted under worst case conditions of humidity, temperature, and air flow rate through the filter element. The employer shall describe the data supporting the cartridge/canister change schedule and the basis for reliance on the data in the employer's respirator program.
(D) A label shall be attached to the filter element(s) to indicate the date and time it is first installed on the respirator.
(E) If a NIOSH-approved end of service life indicator (ESLI) for BD becomes available for an air-purifying filter element, the element may be used until such time as the indicator shows no further useful service life or until replaced at the beginning of the next work shift, whichever comes first.
(F) Regardless of the air purifying element used, if an employee detects the odor of BD, the employer shall replace the air-purifying element(s) immediately.
(3) Respirator selection.
(A) The employer must select appropriate respirators from Table I.
Table 1. -Minimum Requirements for Respiratory Protection for Airborne BD
____________________________
Concentration of airborne BD Minimum required respirator
(ppm) or condition of use
____________________________
Less than or equal to 5 ppm (a) Air-purifying half mask or full facepiece
(5 times PEL). respirator equipped with approved BD or
organic vapor cartridges or canisters.
Cartridges or canisters shall be replaced every
4 hours.
Less than or equal to 10 ppm (a) Air-purifying half mask or full facepiece
(10 times PEL). respirator equipped with approved BD or
organic vapor cartridges or canisters.
Cartridges or canisters shall be replaced every
3 hours.
____________________________
Concentration of airborne BD Minimum required respirator
(ppm) or condition of use
____________________________
Less than or equal to 25 ppm (a) Air-purifying full facepiece respirator
(25 times PEL). equipped with approved BD or organic vapor
cartridges or canisters.
Cartridges or canisters
shall be replaced every 2 hours.
(b) Any powered air-purifying respirator
equipped with approved BD or organic vapor
cartridges. PAPR cartridges shall be replaced
every 2 hours.
(c) Continuous flow supplied air respirator
equipped with a hood or helmet.
Less than or equal to 50 ppm (a) Air-purifying full facepiece respirator
(50 times PEL). equipped with approved BD or organic vapor
cartridges or canisters.
Cartridges or canisters
shall be replaced every (1) hour.
(b) Powered air-purifying respirator
equipped with a tight-fitting facepiece
and an approved BD or organic vapor
cartridges. PAPR cartridges shall be replaced
every (1) hour.
____________________________
Concentration of airborne BD Minimum required respirator
(ppm) or condition of use
____________________________
Less than or equal to 1,000 (a) Supplied air respirator equipped with a
ppm (1,000 times PEL). half mask of full facepiece and operated in
a pressure demand or other positive pressure
mode.
Greater than 1000 ppm (a) Self-contained breathing unknown
concentration, or apparatus equipped with a
firefighting full facepiece and operated in a
pressure demand or other positive pressure
mode.
(b) Any supplied air respirator equipped with
a full facepiece and operated in a pressure
demand or other positive pressure mode in
combination with an auxiliary self-contained
breathing apparatus operated in a pressure
demand or other positive pressure mode.
Escape from IDLH (a) Any positive pressure self-contained
conditions. breathing apparatus with an appropriate
service life.
(b) A air-purifying full facepiece respirator
equipped with a front or back mounted BD or
organic vapor canister.
____________________________
Notes: Respirators approved for use in higher concentrations are permitted to be used in lower concentrations. Full facepiece is required when eye irritation is anticipated.
(B) Air purifying respirators must have filter element(s) approved by NIOSH for organic vapors or BD.
(C) When an employee whose job requires the use of a respirator cannot use a negative pressure respirator, the employer must provide the employee with a respirator that has less breathing resistance, such as a powered air-purifying respirator or supplied air respirator, when the employee is able to use it and if it will provide adequate protection.
(i) Protective clothing and equipment. Where appropriate to prevent eye contact and limit dermal exposure to BD, the employer shall provide protective clothing and equipment at no cost to the employee and shall ensure its use. Eye and face protection shall meet the requirements of section 3382.
(j) Emergency situations. Written plan. A written plan for emergency situations shall be developed, or an existing plan shall be modified, to contain the applicable elements specified in section 3220, Emergency Action Plan, section 3221, Fire Prevention Plan, and in section 5192, Hazardous Waste Operations and Emergency Responses, for each workplace where there is a possibility of an emergency.
(k) Medical screening and surveillance. -
(1) Employees covered. The employer shall institute a medical screening and surveillance program as specified in this subsection for:
(A) Each employee with exposure to BD at concentrations at or above the action level on 30 or more days or for employees who have or may have exposure to BD at or above the PELs on 10 or more days a year;
(B) Employers (including successor owners) shall continue to provide medical screening and surveillance for employees, even after transfer to a non-BD exposed job and regardless of when the employee is transferred, whose work histories suggest exposure to BD:
1. At or above the PELs on 30 or more days a year for 10 or more years;
2. At or above the action level on 60 or more days a year for 10 or more years; or
3. Above 10 ppm on 30 or more days in any past year; and
(C) Each employee exposed to BD following an emergency situation.
(2) Program administration.
(A) The employer shall ensure that the health questionnaire, physical examination and medical procedures are provided without cost to the employee, without loss of pay, and at a reasonable time and place.
(B) Physical examinations, health questionnaires, and medical procedures shall be performed or administered by a physician or other licensed health care professional.
(C) Laboratory tests shall be conducted by an accredited laboratory.
(3) Frequency of medical screening activities. The employer shall make medical screening available on the following schedule:
(A) For each employee covered under subsections (j)(1) (A)-(B), a health questionnaire and complete blood count with differential and platelet count (CBC) every year, and a physical examination as specified below:
1. An initial physical examination that meets the requirements of this rule, if twelve months or more have elapsed since the last physical examination conducted as part of a medical screening program for BD exposure;
2. Before assumption of duties by the employee in a job with BD exposure;
3. Every 3 years after the initial physical examination;
4. At the discretion of the physician or other licensed health care professional reviewing the annual health questionnaire and CBC;
5. At the time of employee reassignment to an area where exposure to BD is below the action level, if the employee's past exposure history does not meet the criteria of subsection (j)(1)(B) for continued coverage in the screening and surveillance program, and if twelve months or more have elapsed since the last physical examination; and
6. At termination of employment if twelve months or more have elapsed since the last physical examination.
(B) Following an emergency situation, medical screening shall be conducted as quickly as possible, but not later than 48 hours after the exposure.
(C) For each employee who must wear a respirator, physical ability to perform the work and use the respirator must be determined as required by section 5144.
(4) Content of medical screening.
(A) Medical screening for employees covered by subsections (j)(1) (A)-(B) shall include:
1. A baseline health questionnaire that includes a comprehensive occupational and health history and is updated annually. Particular emphasis shall be placed on the hematopoietic and reticuloendothelial systems, including exposure to chemicals, in addition to BD, that may have an adverse effect on these systems, the presence of signs and symptoms that might be related to disorders of these systems, and any other information determined by the examining physician or other licensed health care professional to be necessary to evaluate whether the employee is at increased risk of material impairment of health from BD exposure. Health questionnaires shall consist of the sample forms in Appendix C to this section, or be equivalent to those samples;
2. A complete physical examination, with special emphasis on the liver, spleen, lymph nodes, and skin;
3. A CBC; and
4. Any other test which the examining physician or other licensed health care professional deems necessary to evaluate whether the employee may be at increased risk from exposure to BD.
(B) Medical screening for employees exposed to BD in an emergency situation shall focus on the acute effects of BD exposure and at a minimum include: A CBC within 48 hours of the exposure and then monthly for three months; and a physical examination if the employee reports irritation of the eyes, nose, throat, lungs, or skin, blurred vision, coughing, drowsiness, nausea, or headache. Continued employee participation in the medical screening and surveillance program, beyond these minimum requirements, shall be at the discretion of the physician or other licensed health care professional.
(5) Additional medical evaluations and referrals.
(A) Where the results of medical screening indicate abnormalities of the hematopoietic or reticuloendothelial systems, for which a non-occupational cause is not readily apparent, the examining physician or other licensed health care professional shall refer the employee to an appropriate specialist for further evaluation and shall make available to the specialist the results of the medical screening.
(B) The specialist to whom the employee is referred under this subsection shall determine the appropriate content for the medical evaluation, e.g., examinations, diagnostic tests and procedures, etc.
(6) Information provided to the physician or other licensed health care professional. The employer shall provide the following information to the examining physician or other licensed health care professional involved in the evaluation:
(A) A copy of this section including its appendices;
(B) A description of the affected employee's duties as they relate to the employee's BD exposure;
(C) The employee's actual or representative BD exposure level during employment tenure, including exposure incurred in an emergency situation;
(D) A description of pertinent personal protective equipment used or to be used; and
(E) Information, when available, from previous employment-related medical evaluations of the affected employee which is not otherwise available to the physician or other licensed health care professional or the specialist.
(7) The written medical opinion.
(A) For each medical evaluation required by this section, the employer shall ensure that the physician or other licensed health care professional produces a written opinion and provides a copy to the employer and the employee within 15 business days of the evaluation. The written opinion shall be limited to the following information:
1. The occupationally pertinent results of the medical evaluation;
2. A medical opinion concerning whether the employee has any detected medical conditions which would place the employee's health at increased risk of material impairment from exposure to BD;
3. Any recommended limitations upon the employee's exposure to BD; and
4. A statement that the employee has been informed of the results of the medical evaluation and any medical conditions resulting from BD exposure that require further explanation or treatment.
(B) The written medical opinion provided to the employer shall not reveal specific records, findings, and diagnoses that have no bearing on the employee's ability to work with BD. Note:However, this provision does not negate the ethical obligation of the physician or other licensed health care professional to transmit any other adverse findings directly to the employee.
(8) Medical surveillance.
(A) The employer shall ensure that information obtained from the medical screening program activities is aggregated (with all personal identifiers removed) and periodically reviewed, to ascertain whether the health of the employee population of that employer is adversely affected by exposure to BD.
(B) Information learned from medical surveillance activities must be disseminated to covered employees, as defined in subsection (k)(1), in a manner that ensures the confidentiality of individual medical information.
(l) Communication of BD hazards to employees. -
(1) Hazard communication. The employer shall communicate the hazards associated with BD exposure in accordance with the requirements of section 5194, Hazard Communication.
(2) Employee information and training.
(A) The employer shall provide all employees exposed to BD with information and training in accordance with the requirements of section 5194, Hazard Communication.
(B) The employer shall institute a training program for all employees who are potentially exposed to BD at or above the action level or the STEL, ensure employee participation in the program and maintain a record of the contents of such program.
(C) Training shall be provided prior to or at the time of initial assignment to a job potentially involving exposure to BD at or above the action level or STEL and at least annually thereafter.
(D) The training program shall be conducted in a manner that the employee is able to understand. The employee shall ensure that each employee exposed to BD over the action level or STEL is informed of the following:
1. The health hazards associated with BD exposure, and the purpose and a description of the medical screening and surveillance program required by this section;
2. The quantity, location, manner of use, release, and storage of BD and the specific operations that could result in exposure to BD, especially exposures above the PEL or STEL;
3. The engineering controls and work practices associated with the employee's job assignment, and emergency procedures and personal protective equipment;
4. The measures employees can take to protect themselves from exposure to BD.
5. The contents of this standard and its appendices, and
6. The right of each employee exposed to BD at or above the action level or STEL to obtain:
a. medical examinations as required by subsection (j) at no cost to the employee;
b. the employee's medical records required to be maintained by subsection (m)(4); and
c. all air monitoring results representing the employee's exposure to BD and required to be kept by subsection (m)(2).
(3) Access to information and training materials.
(A) The employer shall make a copy of this standard and its appendices readily available without cost to all affected employees and their designated representatives and shall provide a copy if requested.
(B) The employer shall provide to the Chief or NIOSH, or the designated employee representatives, upon request, all materials relating to the employee information and the training program.
(m) Recordkeeping. -
(1) Objective data for exemption from initial monitoring.
(A) Where the processing, use, or handling of products or streams made from or containing BD are exempted from other requirements of this section under subsection (a)(2), or where objective data have been relied on in lieu of initial monitoring under subsection (d)(2)(B), the employer shall establish and maintain a record of the objective data reasonably relied upon in support of the exemption.
(B) This record shall include at least the following information:
1. The product or activity qualifying for exemption;
2. The source of the objective data;
3. The testing protocol, results of testing, and analysis of the material for the release of BD;
4. A description of the operation exempted and how the data support the exemption; and
5. Other data relevant to the operations, materials, processing, or employee exposures covered by the exemption.
(C) The employer shall maintain this record for the duration of the employer's reliance upon such objective data.
(2) Exposure measurements.
(A) The employer shall establish and maintain an accurate record of all measurements taken to monitor employee exposure to BD as prescribed in subsection (d).
(B) The record shall include at least the following information:
1. The date of measurement;
2. The operation involving exposure to BD which is being monitored;
3. Sampling and analytical methods used and evidence of their accuracy;
4. Number, duration, and results of samples taken;
5. Type of protective devices worn, if any; and
6. Name, social security number and exposure of the employees whose exposures are represented.
7. The written corrective action and the schedule for completion of this action required by subsection (d)(7)(B). (continued)