New OSHA Respiratory Protection Standard

Presented by Jay Jamali during the Semiconductor Safety

Association Chapter Meeting (10/98)

Regulations

1-In 1971, OSHA adopted the ANSI standard Z88.2-1969, "Practices for Respiratory Protection," as well as ANSI Standard K13.1-1969, "Identification of Gas Mask Canisters" as its standard for respiratory protection.

A-On February 9, 1979, OSHA announced that 29 CFR 1910.134 would be formally recognized as also being applicable to the construction industry (44 FR 8577).

2-On November 15, 1994, OSHA issued a Notice of Proposed Rulemaking to revise 29 CFR 1910.134.

A-The Final Rule was published in the Federal Register on January 8, 1998.
B-On April 23, 1998, corrections to the regulatory text were published in the Federal Register.

3-By September 8, 1998, the employer must have evaluated the workplace to determine if respirator use is required.

4-The prior Respirator Standard, 1910.134, remains in effect until October 5, 1998, the date when employers must be in compliance with the new standard.

A-On October 5, the prior 1910.134 will be retained, but re-designated as 1910.139.
1) It will apply only to respiratory protection against tuberculosis (TB) until OSHA has promulgated the final standard for Occupational Exposure to Tuberculosis.
B-The new respiratory protection standard also makes the respiratory protection provisions of other health standards consistent with each other and with the final rule.
C-The new standard does not apply to agricultural operations.

5-These guidelines relate to specific provisions of 29 CFR 1910.134 and are provided to assist compliance officers with conducting inspections where the standard may apply.

A-Any subparagraphs of the standard not discussed in this Directive, should be enforced according to their terms. Mask Canisters" as its standard for respiratory protection.
B- In April of 1971, OSHA promulgated 29 CFR 1926.103, the initial respiratory protection standard.

6-The regulation has 5 appendices that are mandatory.

A-Appendix A details fit testing protocols [see paragraph (f)(5)].
B-Appendix B-1 details User Seal Check Procedures [see paragraph g(1)(iii)].
C-Appendix B-2 details Respirator Cleaning Procedures [see paragraph (h)(1)].
D-Appendix C is the OSHA Respirator Medical Evaluation Questionnaire [see paragraph (e)(2)].
E-Appendix D is Information for Employees Using Respirators When Not Required Under the Standard.
1)This appendix must be provided to all employees who voluntarily use respirators. [see paragraph (c)(2), (k)(6)]

6- The new Fed-OSHA standard was Adopted verbatim in California on June 18, 1998 by the Standards Board.

A- Approved by OAL on August 25, 1998
B- Effective November 23, 1998 for employers without a program
C- Final Start-Up Date on May 22, 1999 with a program

7- The following regulations are effected by the new respiratory protection standard in California:

A- TITLE 8, CONSTRUCTION SAFETY ORDERS SECTIONS § 1529 Asbestos, 1531, 1532, 1532.1, AND 1535;
B- GENERAL INDUSTRY SAFETY ORDERS: SECTIONS 3409 AND 3411; 5144 AND 5147; 5190; 5200-5202, 5207-5214, 5216-5218, AND 5220;
C- SHIP BUILDING SAFETY ORDERS SECTION 8358

8- Cal-OSHA GISO 5144 applies to:

A- General Industry,
B- Shipyards,
C- Marine Terminals,
D- Longshoring, and
E- Construction

Enforcement

1- Fed-OSHA has issued a compliance enforcement directive to agency field personnel will also be useful to employers in meeting requirements of the standard.

A- This instruction describes a Federal Program Change for which State adoption is not required.
1) NOTE: In order to effectively enforce safety and health standards, guidance to compliance staff is necessary. Therefore, although adoption of this instruction is not required, States are expected to have standards, enforcement policies and procedures which are at least as effective as those of Federal OSHA.
B- The directive is effective Friday, September 25, 1998.
C- The directive can be accessed through the OSHA Home Page on the Internet World Wide Web (http://www.osha.gov) under "Library/Reading Room" and then "Directives."
D- A supplementary document, "Questions and Answers on the Respiratory Protection Standard," also can be accessed through the OSHA Home Page.
E- CPL 2-0.120 discusses
1) Definitions of terms used in the standard;
2) Requirements for a written respiratory protection program and respiratory protection program administrator;
3) Voluntary use of respirators;
4) Selection of respirators and hazard evaluation;
5) he requirements for employers to develop chemical cartridge change schedules for the respirators worn in their workplaces;
6) Medical evaluation of an employee's fitness to wear a respirator; and
7) Fit testing for employees using negative or positive pressure tight-fitting respirators.
F- The directive also discusses maintenance and care of respirators; training and information; evaluation of the effectiveness of the respirator program; recordkeeping; and how the respirator standard is linked to other OSHA standards.

Permissible Practice

1- In the control of occupational diseases caused by breathing air contaminated with harmful dusts, fogs, fumes, mists, gases, smokes, sprays, or vapors, the primary objective shall be to prevent atmospheric contamination.

2- This shall be accomplished as far as feasible by accepted engineering control measures (for example, enclosure or confinement of the operation, general and local ventilation, and substitution of less toxic materials).

3- When effective engineering controls are not feasible, or while they are being instituted, appropriate respirators shall be used pursuant to this section.

A- The employer shall provide the respirators which are applicable and suitable for the purpose intended.
B- The employer shall be responsible for the establishment and maintenance of a respiratory protection program.

Program Requirements

1- In any workplace where respirators are necessary to protect the health of the employee or whenever respirators are required by the employer, the employer shall establish and implement a written respiratory protection program with worksite-specific procedures.

A- The program shall be updated as necessary to reflect those changes in workplace conditions that affect respirator use.

2- The employer shall include in the program the following provisions, as applicable:

A- Procedures for selecting respirators for use in the workplace;
B- Medical evaluations of employees required to use respirators;
C- Fit testing procedures for tight-fitting respirators;
D- Procedures for proper use of respirators in routine and reasonably foreseeable emergency situations;
E- Procedures and schedules for cleaning, disinfecting, storing, inspecting, repairing, discarding, and otherwise maintaining respirators;
F- Procedures to ensure adequate air quality, quantity, and flow of breathing air for atmosphere-supplying respirators;
G- Training of employees in the respiratory hazards to which they are potentially exposed during routine and emergency situations;
H- Training of employees in the proper use of respirators, including putting on and removing them, any limitations on their use, and their maintenance; and
I- Procedures for regularly evaluating the effectiveness of the program.

3- If no written program exists, but all other provisions of the standard have been met, a violation for lack of a written program would normally not be cited (CPL 2.0-120).

4- Where respirator use is not required:

A- An employer may provide respirators at the request of employees or permit employees to use their own respirators, if the employer determines that such respirator use will not in itself create a hazard.
B- If the employer determines that any voluntary respirator use is permissible, the employer shall provide the respirator users with the information contained in Appendix D to this section ("Information for Employees Using Respirators When Not Required Under the Standard");
1) Merely posting Appendix D is not considered adequate (CPL).
C- In addition, the employer must establish and implement those elements of a written respiratory protection program necessary to ensure that any employee using a respirator voluntarily is medically able to use that respirator, and that the respirator is cleaned, stored, and maintained so that its use does not present a health hazard to the user.
1) Exception: Employers are not required to include in a written respiratory protection program those employees whose only use of respirators involves the voluntary use of filtering facepieces (dust masks).

5- The employer shall designate a program administrator who is qualified by appropriate training or experience that is commensurate with the complexity of the program to administer or oversee the respiratory protection program and conduct the required evaluations of program effectiveness.

A- This individual must have the appropriate accountability and responsibility to manage the full respiratory protection program.
B- Companies with multiple worksites may have a program administrator at each worksite, as long as this person is qualified and retains the accountability and responsibility for the day-to-day operation of the specific program for that site.
C- Alternatively, a company may opt to have one program administrator for several sites and/or one program for several similar sites as long as the program contains the necessary elements and addresses the hazards at those sites.

6- The employer shall provide respirators, training, and medical evaluations at no cost to the employee.

A- It is the intent of the standard that the employer would not be required to incur any costs associated with voluntary use of filtering facepieces other than providing a copy of Appendix D to each user.
B- If employers allow the voluntary use of respirators other than filtering facepieces, the costs associated with ensuring the respirator itself does not create a hazard, such as medical evaluations and maintenance must be provided at no cost to the employee.

Selection

1- The employer must evaluate respiratory hazard(s) in the workplace, identify relevant workplace and user factors, and base respirator selection on these factors.

A- This evaluation shall include a reasonable estimate of employee exposures to respiratory hazard(s) and an identification of the contaminant's chemical state and physical form.
B- Where the employer cannot identify or reasonably estimate the employee exposure, the employer shall consider the atmosphere to be IDLH.

2- The employer shall select a NIOSH-certified respirator.

A- The respirator shall be used in compliance with the conditions of its certification.

3- The employer shall select respirators from a sufficient number of respirator models and sizes so that the respirator is acceptable to, and correctly fits, the user.

4- The employer shall provide the following respirators for employee use in IDLH atmospheres:

A- A full facepiece pressure demand SCBA certified by NIOSH for a minimum service life of thirty minutes, or
B- A combination full facepiece pressure demand supplied-air respirator (SAR) with auxiliary self-contained air supply.
C- Respirators provided only for escape from IDLH atmospheres shall be NIOSH-certified for escape from the atmosphere in which they will be used.
D- All oxygen-deficient atmospheres shall be considered IDLH.
1) Exception: If the employer demonstrates that, under all foreseeable conditions, the oxygen concentration can be maintained within the ranges specified in Table II (i.e., for the altitudes set out in the table), then any atmosphere-supplying respirator may be used.

5- The employer shall provide respirators for atmospheres that are not IDLH that are adequate to protect the health of the employee and ensure compliance with all other OSHA statutory and regulatory requirements, under routine and reasonably foreseeable emergency situations.

6- For protection against gases and vapors, the employer shall provide:

A- An atmosphere-supplying respirator, or
B- An air-purifying respirator, provided that:
1) The respirator is equipped with an end-of-service-life indicator (ESLI) certified by NIOSH for the contaminant; or
2) If there is no ESLI appropriate for conditions in the employer's workplace, the employer implements a change schedule for canisters and cartridges that is based on objective information or data that will ensure that canisters and cartridges are changed before the end of their service life.

7- For protection against particulates, the employer shall provide:

A- An atmosphere-supplying respirator; or
B- An air-purifying respirator equipped with a filter certified by NIOSH under 30 CFR part 11 as a high efficiency particulate air (HEPA) filter, or an air-purifying respirator equipped with a filter certified for particulates by NIOSH under 42 CFR part 84; or
C- For contaminants consisting primarily of particles with mass median aerodynamic diameters (MMAD) of at least 2 micrometers, an air-purifying respirator equipped with any filter certified for particulates by NIOSH.

8- The OSHA CPL recommends that the inspector examine the employer's Hazard Communication Program for further information on existing respiratory hazards in the workplace.

9- Oxygen deficient atmospheres for which the employer may rely on atmosphere-supplying respirators have been listed in Table II of the standard.

A- The value is dependent upon the Altitude.
B- Above 8,000 feet the exception does not apply.
C- Oxygen-enriched breathing air must be supplied above 14,000 feet.

NIOSH Certification

1- NIOSH 30 CFR 11 requirements which regulate the manufacture and sale of non-powered-particulate respirators were replaced by 42 CFR 84 on July 10, 1998.

A- It replaces the Mine Safety and Health Administration's (MSHA) rules and procedures for approval of air-purifying particulate filter respirators.
B- July 10, 1998 marks the end of a three year transition to 42 CFR 84, which gives NIOSH exclusive authority for the testing and certification of 42 CFR 84 respirators, except for some mine emergency devices.
C- Only certification of non-powered, air-purifying, particulate-filter respirators were affected by this change.
D- The remaining portions of Part 11 were incorporated into Part 84 without change.

2- After July 10, 1998, only non powered air-purifying respirators and filters approved under this new regulation can be manufactured.

A- Distributors who have purchased these respirators will be able to sell them until their inventories are depleted.
B- Employers may continue to purchase available products and will be permitted to use them until their inventories are depleted, or until the shelf or service life for the product expires.
C- New models of 42 CFR 84 approved respirators are now available.

3- There will be three classes of particulate respirators in three filter efficiencies for a total of nine new respirator categories.

A- The new classes for particulate respirators are:
1) N for non-oil particulates;
2) R for oil and non oil particulates with an eight hour maximum use stipulation; and
3) P for oil and non oil particulates with no service time restriction.
B- Each class is further categorized by efficiency as either 95 percent, 99 percent, or 100 percent (actually 99.97 percent).

4- However, Dust/Mist and Dust/Mist/Fume Filters may only be used for particulates with mass median aerodynamic diameters (MMAD) of least 2 micrometers, in accordance with paragraph (d)(3)(iv)(C).

A- Welding fumes and silica may be examples of dust particulates that are less than 2 micrometers.
B- If the MMAD cannot be determined, a HEPA filter, or a filter certified by NIOSH under 42 CFR 84 (N95 or higher) must be selected. R100 and P100 filters can be used to replace them.

5- Respirators required to be used in the workplace must be NIOSH-approved and appropriate for the hazard.

A- Unapproved [(d)(1)(ii)] respirators can be cited even where an overexposure has not been established (CPL).

Changeout Schedule

1- In the old respirator standard, employers could use odor detection as a way to determine when a cartridge needed to be changed.

A- The new standard prohibits the use of warning properties as the sole basis for determining change schedules.
B- However respirator users should be trained to understand that abnormal odor or irritation is evidence that respirator cartridges need to be replaced.

2- If a cartridge/canister air purifying respirator for the protection against gases and vapors does not have an End of Service Life Indicator (ESLI), then the employer must implement a cartridge/canister change schedule based on objective information that will ensure the cartridges/canisters are changed before the end of their service life.

A- The purpose of a change schedule is to establish the time period for replacing respirator cartridges and canisters; this is critical to preventing contaminants from respirator breakthrough, and thereby over-exposing workers.
B- Where an effective change schedule is implemented, air-purifying gas and vapor respirators may be used for hazardous chemicals, including those with few or no warning properties.

3- OSHA will phase in enforcement of the cartridge change schedule provision of the new respirator rule so employers can incorporate data into programs as it becomes available.

4- OSHA will:

A- Ask for proof that workplace conditions, such as humidity and chemical mixtures, were used to create the change schedule.
B- Require that change schedules clearly protect workers so employers should err on the side of caution.
C- NOT require complex mathematical calculations to be endlessly computed
D- NOT consider the adoption of somebody else's change schedule without site considerations as sufficient.
E- NOT accept a change schedule that is based on the fact that the employer has seen no apparent adverse health effects.

5- The requirements for several of OSHA's chemical specific standards already address this issue and have been retained. These include:

A- Acrylonitrile 1910.1045(h)(2)(ii) end-of-service life or end of shift (whichever occurs first)
B- Benzene 1910.1028(g)(2)(ii) end-of-service life or beginning of shift (whichever occurs first)
C- Butadiene 1910.1051 (h)(2)(ii) every 1, 2 or 4 hours dependent on concentration according to Table 1 and at beginning of each shift
D- Formaldehyde 1910.1048 (g)(2)(ii) - for cartridges every three hours or end of shift (whichever is sooner);
E- Vinyl chloride 1910.1017(g)(3)(ii) end-of-service life or end of shift in which they are first used (whichever occurs first)
F- Methylene chloride 1910.1052 (g)(2)(ii) - canisters may only be used for emergency escape and must be replaced after use.

6- Change schedules for all other gases and vapors must be established and implemented by the employer.

A- Data and information relied upon to establish the schedule must be included in the written respiratory protection program.
B- OSHA has stated in the preamble to the final rule that the employer is not required to research and analyze experimental breakthrough data, but may obtain information from sources who have expertise and knowledge that can help the employer to develop reasonable change schedules.

7- The following methods can be used to determine the changeout schedule:

A- Manufacturers Objective Data,
B- Experimental Methods,
C- Mathematical Predictive Modeling,
D- Analogous Chemical Structures,
E- Workplace Simulations,

8- Manufacturers Objective Data:

A- Respirator cartridge model-specific objective data that is available from the manufacturer or through a distributor may be used to establish change schedules.
B- Objective data may be presented in tabular or graphical format or simply provided verbally over a manufacturer's telephone help line.
C- Some manufacturers have developed elaborate computer programs available on the Internet that provide the necessary objective data to the user.

9- Experimental Methods:

A- Experimental breakthrough-time data from a laboratory based on worst case testing of simulated workplace conditions.
B- This method can provide fairly accurate service life data compared to other available methods.

10- Mathematical Predictive Modeling:

A- Is based on predictive equations.
B- These models are typically complex and require considerable expertise to apply.
C- They also require some proprietary information from the respirator manufacturer.
D- OSHA fully supports the further development and validation of these models.
E- The agency believes that respirator manufacturers may be in the best position to apply them to their products.

11- Analogous Chemical Structures:

A- Employer would rely on service life values from other chemicals having analogous chemical structure to the contaminant under evaluation for breakthrough.
B- Or in some cases a chemical with known migration may reasonably be anticipated to act as a surrogate for a similar chemical that would have less rapid migration
1) An employer could assume that a heavier, less volatile compound than another in the same chemical series that had been tested for breakthrough would breakthrough no faster than the latter compound, such as benzene versus toluene.)
C- The use of this method requires a substantial amount of judgement and assumption of similar chemical properties.
D- The use of analogous chemical structures should be infallible as long as objective data or information for lower molecular weight compounds is used to predict the breakthrough times for higher molecular weight analogues containing only additional methyl or phenyl groups.
E- Data from higher molecular weight groups should not be used to predict the behavior of analogous substances with lower molecular weight.
F- This approach relies heavily on experimental data and expert analysis.
G- This method may be less accurate than others and should be used only when better information is not available.

12- Workplace Simulations:

A- Unvalidated methods exist or are under development where the respirator cartridge is tested in the workplace in "real time" and under actual conditions of use.
B- Simple designs have been informally described to the agency.
C- Workplace air during representative conditions is drawn over the cartridge at a rate approximating normal breathing at a higher work rate.
D- An air sampling/analytic device would be placed on the other side of the filter to measure the time of breakthrough.
E- Employers could incorporate this type of testing into their air monitoring program using sampling strategies established in their workplace.
F- In theory, these approaches should be an accurate method for determining change schedules and could accommodate fluctuating conditions of humidity, concentration, etc., to allow less conservative schedules that utilize a larger fraction of the true service life.

13- Rules of Thumb:

A- Generalized rules or guidance can be generated from experimental work.
B- Presented below is a rule of thumb for estimating organic vapor service life found in Chapter 36 of the American Industrial Hygiene Association publication "The Occupational Environment Evaluation and Control".
C- If a chemical's boiling point is >70 C and the concentration is less than 200 ppm you can expect a service life of 8 hours at a normal work rate.
1) Humidity above 85% will reduce service life by 50%.
2) Service life is inversely proportional to work rate.
3) Reducing concentration by a factor of ten will increase service life by a factor of five.
D- These generalizations should only be used in concert with one of the other methods of predicting service life for specific contaminants.

14- Change Schedules For Mixtures: Establishing cartridge service life for mixtures of contaminants is a complex task and one that requires considerable professional judgement to create a reasonable change schedule.

A- Cartridge service life for mixtures is best determined using experimental methods.
B- The change schedule for a mixture should be based on reasonable assumptions that include a margin of safety for the worker wearing the respirator.
C- Where the individual compounds in the mixture have similar breakthrough times (i.e. within one order of magnitude), service life of the cartridge should be established assuming the mixture stream behaves as a pure system of the most rapidly migrating component or compound with the shortest breakthrough time (i.e., sum up the concentration of the components).
D- Where the individual compounds in the mixture vary by 2 orders of magnitude or greater, the service life may be based on the contaminant with the shortest breakthrough time.

15- Chemical Contaminant Migration:

A- Contaminants have a tendency to migrate through cartridge/canister sorbent material during periods of storage or non-use.
B- This is characteristic of the contaminant-carbon bed interaction for organic chemicals with boiling points below 65 Centigrade and would predictably shorten breakthrough times.
C- In cases where respirators are used for multiple days this could present an additional exposure to the respirator user.
D- Where contaminant migration is possible, respirator cartridges/canisters should be changed after every workshift where exposure occurs unless the employer has specific objective data to the contrary (desorption studies) showing the performance of the cartridge in the conditions and schedule of use/non-use found in the workplace.

16- If the breakthrough time is rapid (minutes), air purifying respirators may not be feasible and supplied air respirators should be used.

Medical Evaluation

1- Using a respirator may place a physiological burden on employees that varies with the type of respirator worn, the job and workplace conditions in which the respirator is used, and the medical status of the employee.

A- Employers must provide a medical evaluation to determine each employee's fitness to wear a respirator.

2- Medical evaluations are required for all respirator users except for employees who voluntarily use dusts masks and for those whose only respirator would be the use of escape-only respirators.

A- SCBA's are not considered escape-only respirators.

3- The medical evaluation must be provided before the initial fit-testing and before the respirator is used for the first time.

4- The employer shall provide additional medical evaluations if:

A- An employee reports medical signs or symptoms that are related to ability to use a respirator;
B- A Physician or other Licensed Health Care Professional (PLHCP), supervisor, or the respirator program administrator informs the employer that an employee needs to be reevaluated;
C- Information from the respiratory protection program, including observations made during fit testing and program evaluation, indicates a need for employee reevaluation; or
D- A change occurs in workplace conditions (e.g., physical work effort, protective clothing, temperature) that may result in a substantial increase in the physiological burden placed on an employee.

5- The employer may discontinue an employee's medical evaluations when the employee is no longer required to use a respirator.

6- Medical evaluations consist of the administration of a medical questionnaire or provision of a physical examination that elicits the same information as the questionnaire for the employee.

A- The medical questionnaire is found in the mandatory Appendix C of the standard,
B- An employer, who opts to provide physical examinations to his or her employees, need not also administer the medical questionnaire.

7- When using the questionnaire, the employer may not change the wording of questions in Part A, if the form is being used as the sole means to evaluate employees.

A- The PLHCP may add questions to the questionnaire that could assist in determining whether the employee can perform the work while wearing respiratory protection.

8- The medical questionnaire and examinations shall be administered confidentially during the employee's normal working hours or at a time and place convenient to the employee.

A- The employer must ensure that the questionnaire is administered in such a manner that employees can understand the content and the confidentiality of the record is maintained.
B- Where the employee cannot understand English, the employer must have the questionnaire translated into the employee's language either through a translator or a translated written copy.
1) The questionnaire has been translated into Spanish and is available on OSHA's homepage (www.osha.gov) in the Respirator Q & A Document.
C- In cases where the employee cannot read, the employee can request someone other than the employer to orally read them the questionnaire or the PLHCP may obtain through an interview or examination the same information requested on the medical questionnaire.

9- In order to maintain strict confidentiality of the information obtained in the questionnaire, the employer's role is limited to distributing the blank questionnaire to the employee for him or her to fill out, or providing it to the PLHCP, who will administer the questionnaire to the employee.

A- If the employer provides the questionnaire to the employee, an addressed and postage-paid envelope should also be provided for the employee to mail it to the PLHCP.
B- The questionnaire and findings may also be maintained by the employer's medical office, if the health office is administratively separate from the employer's central administration offices.

10- If the employer does not have or chooses not to use an in-house medical staff, arrangements must be made for a PLHCP to perform the medical evaluations.

A- The PLHCP may be a physician, a registered nurse, a nurse practitioner, a physician assistant, or other licensed health care professional acting within the scope of his or her state license, registration, or certification.

11- The employer shall ensure that a follow-up medical examination is provided for an employee who gives a positive response to any question among questions 1 through 8 in Section 2, Part A of Appendix C or whose initial medical examination demonstrates the need for a follow-up medical examination.

A- The follow-up medical examination shall include any medical tests, consultations, or diagnostic procedures that the PLHCP deems necessary to make a final determination.

12- The following information must be provided to the PLHCP before the PLHCP makes a recommendation concerning an employee's ability to use a respirator:

A- The type and weight of the respirator to be used by the employee;
B- The duration and frequency of respirator use (including use for rescue and escape);
C- The expected physical work effort;
D- Additional protective clothing and equipment to be worn; and
E- Temperature and humidity extremes that may be encountered.
F- The employer shall provide the PLHCP with a copy of the written respiratory protection program and a copy of this section.

13- In determining the employee's ability to use a respirator, the employer shall:

A- Obtain a written recommendation regarding the employee's ability to use the respirator from the PLHCP.
B- The recommendation shall provide only the following information:
1) Any limitations on respirator use related to the medical condition of the employee, or relating to the workplace conditions in which the respirator will be used, including whether or not the employee is medically able to use the respirator;
2) The need, if any, for follow-up medical evaluations; and
3) A statement that the PLHCP has provided the employee with a copy of the PLHCP's written recommendation.

14- The employer shall provide the employee with an opportunity to discuss the questionnaire and examination results with the PLHCP.

15- If the respirator is a negative pressure respirator and the PLHCP finds a medical condition that may place the employee's health at increased risk if the respirator is used, the employer shall provide a PAPR.

A- If the PLHCP's medical evaluation finds that the employee can use such a respirator;
B- If a subsequent medical evaluation finds that the employee is medically able to use a negative pressure respirator, then the employer is no longer required to provide a PAPR.

16- Where employers use a transient workforce, (e.g., temporary or construction workers), the employer may accept the written medical recommendation of the employee's ability to use a respirator as determined by their previous employer's PLHCP only if the work conditions and type and weight of the respirator remains the same and appropriate for use at their new work site.

A- In this situation, the employer must obtain from the previous employer a copy of the PLHCPs written recommendation.

17- Employees who refuse to be medically evaluated cannot be assigned to work in areas where they are required to wear a respirator.

Fit Testing

1- The employer shall ensure that an employee using a tight-fitting facepiece respirator is fit tested prior to initial use of the respirator, whenever a different respirator facepiece (size, style, model or make) is used, and at least annually thereafter.

A- The employer shall conduct an additional fit test whenever the employee reports, or the employer, PLHCP, supervisor, or program administrator makes visual observations of, changes in the employee's physical condition that could affect respirator fit.
1) Such conditions include, but are not limited to, facial scarring, dental changes, cosmetic surgery, or an obvious change in body weight.

2- The employer shall ensure that employees using a tight-fitting facepiece respirator pass an appropriate QLFT or QNFT.

A- If after passing a qualitative fit test (QLFT) or quantitative fit test (QNFT), the employee subsequently notifies the employer, program administrator, supervisor, or PLHCP that the fit of the respirator is unacceptable, the employee shall be given a reasonable opportunity to select a different respirator facepiece and to be retested.

3- The fit test shall be administered using an OSHA-accepted QLFT or QNFT protocol.

A- The OSHA-accepted QLFT and QNFT protocols and procedures are contained in Appendix A.

4- QLFT may only be used to fit test negative pressure air-purifying respirators that must achieve a fit factor of 100 or less.

5- If the fit factor, as determined through an OSHA-accepted QNFT protocol, is equal to or greater than 100 for tight-fitting half facepieces, or equal to or greater than 500 for tight-fitting full facepieces, the QNFT has been passed with that respirator.

6- Fit testing of tight-fitting atmosphere-supplying respirators and tight-fitting powered air-purifying respirators shall be accomplished by performing quantitative or qualitative fit testing in the negative pressure mode, regardless of the mode of operation (negative or positive pressure) that is used for respiratory protection.

A- Qualitative fit testing of these respirators shall be accomplished by:
1) Temporarily converting the respirator user's actual facepiece into a negative pressure respirator with appropriate filters, or
2) By using an identical negative pressure air-purifying respirator facepiece with the same sealing surfaces as a surrogate for the atmosphere-supplying or powered air-purifying respirator facepiece.
B- Quantitative fit testing of these respirators shall be accomplished by modifying the facepiece to allow sampling inside the facepiece in the breathing zone of the user, midway between the nose and mouth.
1) This requirement shall be accomplished by installing a permanent sampling probe onto a surrogate facepiece, or by using a sampling adapter designed to temporarily provide a means of sampling air from inside the facepiece.
C-Any modifications to the respirator facepiece for fit testing shall be completely removed, and the facepiece restored to NIOSH-approved configuration, before that facepiece can be used in the workplace.

Fit-Testing Methods

Test QLFT QNFT
Half-Face, Negative Pressure, APR (<100 fit factor) Yes Yes
Full-Face, Negative Pressure, APR (<100 fit factor) used in atmospheres up to 10 times the PEL Yes Yes
Full-Face, Negative Pressure, APR (>100 fit factor) No Yes
PAPR Yes Yes
Supplied-Air Respirators (SAR), or SCBA used in Negative Pressure (Demand Mode) (>100 fit factor) No Yes
Supplied-Air Respirators (SAR), or SCBA used in Positive Pressure (Pressure Demand Mode) Yes Yes
SCBA - Structural Fire Fighting, Positive Pressure Yes Yes
SCBA/SAR - IDLH, Positive Pressure Yes Yes
Mouthbit Respirators Fit-testing Not Required
Loose-fitting Respirators (e.g., hoods, helmets) Fit-testing Not Required

Respirator Use

1- Employers must establish and implement procedures for the proper use of respirators.

2- These requirements include prohibiting conditions that may result in facepiece seal leakage, preventing employees from removing respirators in hazardous environments, taking actions to ensure continued effective respirator operation throughout the work shift, and establishing procedures for the use of respirators in IDLH atmospheres or in interior structural firefighting situations.

3- The employer shall not permit respirators with tight-fitting facepieces to be worn by employees who have:

A- Facial hair that comes between the sealing surface of the facepiece and the face or that interferes with valve function; or
B- Any condition that interferes with the face-to-facepiece seal or valve function.

4- If an employee wears corrective glasses or goggles or other personal protective equipment, the employer shall ensure that such equipment is worn in a manner that does not interfere with the seal of the facepiece to the face of the user.

5- For all tight-fitting respirators, the employer shall ensure that employees perform a user seal check each time they put on the respirator using the procedures in Appendix B-1 or procedures recommended by the respirator manufacturer that the employer demonstrates are as effective as those in Appendix B-1.

6- Appropriate surveillance shall be maintained of work area conditions and degree of employee exposure or stress.

A- When there is a change in work area conditions or degree of employee exposure or stress that may affect respirator effectiveness, the employer shall reevaluate the continued effectiveness of the respirator.

7- The employer shall ensure that employees leave the respirator use area:

A- To wash their faces and respirator facepieces as necessary to prevent eye or skin irritation associated with respirator use; or
B- If they detect vapor or gas breakthrough, changes in breathing resistance, or leakage of the facepiece; or
C- To replace the respirator or the filter, cartridge, or canister elements.

8- If the employee detects vapor or gas breakthrough, changes in breathing resistance, or leakage of the facepiece, the employer must replace or repair the respirator before allowing the employee to return to the work area.

9-For all IDLH atmospheres, the employer shall ensure that:

A-One employee or, when needed, more than one employee is located outside the IDLH atmosphere;
B-Visual, voice, or signal line communication is maintained between the employee(s) in the IDLH atmosphere and the employee(s) located outside the IDLH atmosphere;
C-The employee(s) located outside the IDLH atmosphere are trained and equipped to provide effective emergency rescue;
D-The employer or designee is notified before the employee(s) located outside the IDLH atmosphere enter the IDLH atmosphere to provide emergency rescue;
E-The employer or designee authorized to do so by the employer, once notified, provides necessary assistance appropriate to the situation;
F-Employee(s) located outside the IDLH atmospheres are equipped with:
1)Pressure demand or other positive pressure SCBAs, or a pressure demand or other positive pressure supplied-air respirator with auxiliary SCBA; and either
2)Appropriate retrieval equipment for removing the employee(s) who enter(s) these hazardous atmospheres where retrieval equipment would contribute to the rescue of the employee(s) and would not increase the overall risk resulting from entry; or
3)Equivalent means for rescue where retrieval equipment is not required under subsection (g)(3)(F)2.

Structural Firefighting

1-At least two employees enter the IDLH atmosphere and remain in visual or voice contact with one another at all times;

2-At least two employees are located outside the IDLH atmosphere; and

3-All employees engaged in interior structural firefighting use SCBAs.

4-One of the two individuals located outside the IDLH atmosphere may be assigned to an additional role, such as incident commander in charge of the emergency or safety officer, so long as this individual is able to perform assistance or rescue activities without jeopardizing the safety or health of any firefighter working at the incident.

5-Nothing in this section is meant to preclude firefighters from performing emergency rescue activities before an entire team has assembled.

Respirator Maintenance

1-Employer must provide for the cleaning and disinfecting, storage, inspection, and repair of respirators used by employees.

2-The employer shall provide each respirator user with a respirator that is clean, sanitary, and in good working order.

3-The employer shall ensure that respirators are cleaned and disinfected using the procedures in Appendix B-2, § 5144. Respiratory Protective Equipment Protection.

Definitions:

1-The revised standard now contains definitions in paragraph (b) that provide a clearer understanding of specific terminology used in the standard and how these terms are applied to respirators and their use.

2-Some definitions in the proposal were not included in the final standard, and some new definitions were added.

A-"Adequate warning properties" was not included in the final standard because the two major warning properties, odor and irritation, are unreliable or otherwise inappropriate to be used as primary indicators of sorbent exhaustion.
B-"Assigned Protection Factor" has not yet been included in the standard. OSHA is conducting further rulemaking on this issue, and will eventually add the APFs to the final standard. In the interim, OSHA will continue to refer to NIOSH APFs except in cases where APFs have been published in substance-specific standards or are addressed by OSHA in separate letters of interpretation. Employers must rely on the best available information when selecting the appropriate respirator.
C-"Filtering facepiece" (dust mask) means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium. Whenever a filtering facepiece is used to meet the requirements of the standard, it must be NIOSH approved.

3-A "HEPA filter" (High Efficiency Particulate Air) is a filter that is 99.97% efficient in removing monodispersed particles of 0.3 micrometers in diameter. NIOSH no longer uses this term in its new respirator certification standard (42 CFR 84). However, OSHA has retained this definition because it is used in many of the existing substance-specific standards. When HEPA filters are required by an OSHA standard, N100, R100, and P100 filters can be used to replace them.

Air-purifying respirator means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

Assigned protection factor (APF) [Reserved]

Atmosphere-supplying respirator means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SARs) and self-contained breathing apparatus (SCBA) units.

Canister or cartridge means a container with a filter, sorbent, or catalyst, or combination of these items, which removes specific contaminants from the air passed through the container.

Demand respirator means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

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 an airborne contaminant.

Employee exposure means exposure to a concentration of an airborne contaminant that would occur if the employee were not using respiratory protection.

End-of-service-life indicator (ESLI) means a system that warns the respirator user of the approach of the end of adequate respiratory protection, for example, that the sorbent is approaching saturation or is no longer effective.

Escape-only respirator means a respirator intended to be used only for emergency exit.

Filter or air purifying element means a component used in respirators to remove solid or liquid aerosols from the inspired air.

Filtering facepiece (dust mask) means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium.

Fit factor means a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

Fit test means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual. (See also Qualitative fit test QLFT and Quantitative fit test QNFT.)

Helmet means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

High efficiency particulate air (HEPA) filter means a filter that is at least 99.97% efficient in removing monodisperse particles of 0.3 micrometers in diameter. The equivalent NIOSH 42 CFR 84 particulate filters are the N100, R100, and P100 filters.

Hood means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

Immediately dangerous to life or health (IDLH) means an atmosphere that poses an immediate threat to life, would cause irreversible adverse health effects, or would impair an individual's ability to escape from a dangerous atmosphere.

Interior structural firefighting means the physical activity of fire suppression, rescue or both, inside of buildings or enclosed structures which are involved in a fire situation beyond the incipient stage.

Loose-fitting facepiece means a respiratory inlet covering that is designed to form a partial seal with the face.

Maximum use concentration (MUC) [Reserved].

Negative pressure respirator (tight fitting) means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

Oxygen deficient atmosphere means an atmosphere with an oxygen content below 19.5% by volume.

Physician or other licensed health care professional (PLHCP) means 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 health care services required by subsection (e).

Positive pressure respirator means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

Powered air-purifying respirator (PAPR) means an air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the inlet covering.

Pressure demand respirator means a positive pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

Qualitative fit test (QLFT) means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

Quantitative fit test (QNFT) means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

Respiratory inlet covering means that portion of a respirator that forms the protective barrier between the user's respiratory tract and an air-purifying device or breathing air source, or both. It may be a facepiece, helmet, hood, suit, or a mouthpiece respirator with nose clamp.

Self-contained breathing apparatus (SCBA) means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

Service life means the period of time that a respirator, filter or sorbent, or other respiratory equipment provides adequate protection to the wearer.

Supplied-air respirator (SAR) or airline respirator means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

Tight-fitting facepiece means a respiratory inlet covering that forms a complete seal with the face.

User seal check means an action conducted by the user to determine if the respirator is properly seated to the face.