1218-0099 2011 Final ICR 05-23-11

SUPPORTING STATEMENT FOR THE

INFORMATION COLLECTION REQUIREMENTS OF THE

RESPIRATORY PROTECTION STANDARD (29 CFR 1910.134)^1,2

(OMB CONTROL NO. 1218-0099 (May 2011))

A. JUSTIFICATION

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.

The Occupational Safety and Health Act’s (OSH Act) main objective is to “assure so far as possible every working man and woman in the Nation safe and healthful working conditions and to preserve our human resources” (29 U.S.C. 651). To achieve this objective, the OSH Act specifically authorizes “the development and promulgation of occupational safety and health regulations” (29 U.S.C. 651).

To protect worker health, the OSH Act authorizes the Occupational Safety and Health Administration (“OSHA” or “Agency”) to develop standards that provide for “monitoring or measuring employee exposure” to occupational hazards and “prescribe the type and frequency of medical examinations and other tests which shall be made available [by the employer] to employees exposed to such hazards in order to most effectively determine whether the health of such employees is adversely affected by such exposure” (29 U.S.C. 655). In addition, the OSH Act mandates that “[e]ach employer shall make, keep and preserve, and make available to the Secretary [of Labor] . . . such records regarding [their] activities relating to this Act as the Secretary . . . may prescribe by regulation as necessary or appropriate for the enforcement of this Act or for developing information regarding the causes and prevention of occupational accidents and illnesses” (29 U.S.C. 657). In addition, the OSH Act directs OSHA to “issue regulations requiring employers to maintain accurate records of employee exposure to potentially toxic materials or other harmful physical agents which are required to be monitored and measured," and further specifies that such regulations provide “for each employee or former employee to have access to such records as will indicate [their] own exposure to toxic materials or harmful physical agents” (29 U.S.C. 657). The OSH Act states further that “[t]he Secretary . . . shall . . . prescribe such rules and regulations as [he/she] may deem necessary to carry out [their] responsibilities under this Act, including rules and regulations dealing with the inspection of an employer’s establishment” (29 U.S.C. 651).

The Respiratory Protection Standard, §1910.134, (the “Standard”) assists employers in protecting the health of workers exposed to airborne contaminants, physical hazards, and biological agents. The Standard contains requirements for program administration; a written respirator-protection program with worksite-specific procedures; respirator selection; worker training; fit testing; medical evaluation; respirator use; respirator cleaning, maintenance, and repair; and other provisions. Items 2 and 12 below describe the specific information collection requirements of the Standard.

2. Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.

The following are the collection of information requirements as stated in the Standard, followed by discussions indicating how, by whom, and for what purpose the information is used for each of these requirements.

A. Respiratory protection program (§1910.134(a) and (c))

§1910.134(a)(2) - A respirator shall be provided to each employee when such equipment is necessary to protect the health of such employee. The employer shall provide the respirators which are applicable and suitable for the purpose intended. The employer shall be responsible for the establishment and maintenance of a respiratory protection program, which shall include the requirements outlined in paragraph (c) of this section. The program shall cover each employee required by this section to use a respirator.

§1910.134(c)(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. The program shall be updated as necessary to reflect those changes in workplace conditions that affect respirator use. The employer shall include in the program the following provisions of this section, as applicable:

§1910.134(c)(1)(i) - Procedures for selecting respirators for use in the workplace;

§1910.134(c)(1)(ii) - Medical evaluations of employees required to use respirators;

§1910.134(c)(1)(iii) - Fit testing procedures for tight-fitting respirators;

§1910.134(c)(1)(iv) - Procedures for proper use of respirators in routine and reasonably foreseeable emergency situations;

§1910.134(c)(1)(v) - Procedures and schedules for cleaning, disinfecting, storing, inspecting, repairing, discarding, and otherwise maintaining respirators;

§1910.134(c)(1)(vi) - Procedures to ensure adequate air quality, quantity, and flow of breathing air for atmosphere-supplying respirators;

§1910.134(c)(1)(vii) - Training of employees in the respiratory hazards to which they are potentially exposed during routine and emergency situations;

§1910.134(c)(1)(viii) - Training of employees in the proper use of respirators, including putting on and removing them, any limitations on their use, and their maintenance; and

§1910.134(c)(1)(ix) - Procedures for regularly evaluating the effectiveness of the program.

§1910.134(c)(2) - Where respirator use is not required:

§1910.134(c)(2)(i) - 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. 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"); and

§1910.134(c)(2)(ii) - 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. 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).

§1910.134(c)(3) - 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.

§1910.134(c)(4) - The employer shall provide respirators, training, and medical evaluations at no cost to the employee.

Purpose: In developing and implementing written programs, employers must address the respiratory hazards in the workplace. This process requires employers to identify, measure, and document the hazardous atmospheres their workers may encounter during routine operations, as well as reasonably foreseeable emergencies that may occur in the workplace. When changes in atmospheric hazards or other workplace conditions affect respirator use, employers must update their written programs as appropriate.³ Accordingly, a written program, properly updated, permits employers and OSHA compliance officers to assess the adequacy of the respiratory protection provided to workers.

B. Medical evaluation (§1910.134(e))

Using a respirator may place a physiological burden on workers 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 worker. Accordingly, this paragraph specifies the minimum requirements for medical evaluation that employers must implement to determine the worker's ability to use a respirator.

§1910.134(e)(1) - General. The employer shall provide a medical evaluation to determine the employee's ability to use a respirator, before the employee is fit tested or required to use the respirator in the workplace. The employer may discontinue an employee's medical evaluations when the employee is no longer required to use a respirator.

Medical evaluation procedures (§1910.134(e)(2))

§1910.134(e)(2)(i) - The employer shall identify a physician or other licensed health care professional (PLHCP) to perform medical evaluations using a medical questionnaire or an initial medical examination that obtains the same information as the medical questionnaire.

§1910.134(e)(2)(ii) - The medical evaluation shall obtain the information requested by the questionnaire in Sections 1 and 2, Part A of Appendix C of this section.

Purpose: The medical evaluation program ensures that any worker required to use a respirator can tolerate the: physiological burden associated with such use, including the burden imposed by the respirator itself (e.g., its weight and breathing resistance during both normal operation and under conditions of filter, canister, or cartridge overload); musculoskeletal stress; limitations on auditory, visual, and odor sensations; and physical and psychological isolation. Several job and workplace conditions also impose a physiological load on the worker who uses a respirator, including the duration and frequency of respirator use, the level of physical work effort, the use of protective clothing, and temperature extremes or high humidity. Job- and workplace-related stressors may interact with respirator characteristics to increase the physiological stress experienced by workers. For example, wearing protective clothing while performing heavy work can be highly stressful. Also, specific medical conditions can compromise a worker’s ability to tolerate the physiological burdens imposed by respirator use, thereby placing the worker at increased risk of illness, injury, and even death. Such conditions include cardiovascular and respiratory diseases, reduced pulmonary function caused by factors such as smoking or prior exposure to toxic respiratory hazards, neurological or musculoskeletal disorders (e.g., ringing in the ears, epilepsy, lower back pain), and impaired sensory function (e.g., a perforated ear drum, reduced olfactory function). Psychological conditions, such as claustrophobia, also can impair respirator use and may cause significant elevations in heart rate that can jeopardize the health of workers who are at high risk for cardiopulmonary disease.

Follow-up medical examination (§1910.134(e)(3))

§1910.134(e)(3)(i) - 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.

§1910.134(e)(3)(ii) - The follow-up medical examination shall include any medical tests, consultations, or diagnostic procedures that the PLHCP deems necessary to make a final determination.

Purpose: The questionnaire and initial medical examination provide information about medical conditions and physical systems that may prevent or limit workers from using some types of respirators.

Supplemental information for the PLHCP (§1910.134(e)(5))

§1910.134(e)(5)(i) - The following information must be provided to the PLHCP before the PLHCP makes a recommendation concerning an employee's ability to use a respirator⁴:

§1910.134(e)(5)(i)(A) - (A) The type and weight of the respirator to be used by the employee;

§1910.134(e)(5)(i)(B) - The duration and frequency of respirator use (including use for rescue and escape);

§1910.134(e)(5)(i)(C) - The expected physical work effort;

§1910.134(e)(5)(i)(D) - Additional protective clothing and equipment to be worn; and

§1910.134(e)(5)(i)(E) - Temperature and humidity extremes that may be encountered.

§1910.134(e)(5)(iii) - The employer shall provide the PLHCP with a copy of the written respiratory protection program and a copy of this section.

Purpose: This information is important to the PLHCP in making a recommendation regarding the worker’s medical ability to use the respirator. Providing PLHCPs with information about the type of respirator and its use, as well as job and workplace, assists PLHCPs in determining if these factors may interact with preexisting medical conditions (identified through the medical questionnaire or medical examination) to impair a worker’s ability to use the respirator. This information also allows the PLHCP to limit the conditions under which the worker uses a respirator.

Additional medical evaluations (§1910.134(e)(7))

At a minimum, the employer shall provide additional medical evaluations that comply with the requirements of this section if:

§1910.134(e)(7)(i) - An employee reports medical signs or symptoms that are related to ability to use a respirator;

§1910.134(e)(7)(ii) - A PLHCP, supervisor, or the respirator program administrator informs the employer that an employee needs to be reevaluated;

§1910.134(e)(7)(iii) - Information from the respiratory protection program, including observations made during fit testing and program evaluation, indicates a need for employee reevaluation; or

§1910.134(e)(7)(iv) - 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.

Purpose: This requirement ensures that a worker remains medically eligible to use a respirator during exposure to atmospheric contaminants in the workplace.

C. Fit testing (§1910.134(f))

This paragraph requires that, before a worker may be required to use any respirator with a negative or positive pressure tight-fitting facepiece, the worker must be fit tested with the same make, model, style, and size of respirator that will be used. This paragraph specifies the kinds of fit tests allowed, the procedures for conducting them, and how the results of the fit tests must be used.⁵

§1910.134(f)(1) The employer shall ensure that employees using a tight-fitting facepiece respirator pass an appropriate qualitative fit test (QLFT) or quantitative fit test (QNFT) as stated in this paragraph.

§1910.134(f)(2) 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.

§1910.134(f)(3) - 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. Such conditions include, but are not limited to, facial scarring, dental changes, cosmetic surgery, or an obvious change in body weight.

Purpose: Respirators must fit properly to provide protection. If a tight seal is not maintained between the facepiece and the worker's face, contaminated air will be drawn into the facepiece and be breathed by the worker. The fit testing requirement of paragraph (f) seeks to protect the worker against breathing contaminated ambient air and is one of the core provisions of the respirator program required by this standard.

D. Maintenance and care of respirators (§1910.134(h))

Storing and marking emergency-use respirators (§1910.134(h)(2)(ii)(B))

This paragraph requires the employer to provide for the cleaning and disinfecting, storage, inspection, and repair of respirators used by workers.

§1910.134(h)(2)(ii)(B) - Stored in compartments or in covers that are clearly marked as containing emergency respirators; and

§1910.134(h)(2)(ii)(C) - Stored in accordance with any applicable manufacturer instructions.

Certification of inspection records for emergency-use respirators - (§1910.134(h)(3)(iv)(A) and (h)(3)(iv)(B))

§1910.134(h)(3)(iv) - For respirators maintained for emergency use, the employer shall:

§1910.134(h)(3)(iv)(A) - Certify the respirator by documenting the date the inspection was performed, the name (or signature) of the person who made the inspection, the findings, required remedial action, and a serial number or other means of identifying the inspected respirator; and

§1910.134(h)(3)(iv)(B) - Provide this information on a tag or label that is attached to the storage compartment for the respirator, is kept with the respirator, or is included in inspection reports stored as paper or electronic files. This information shall be maintained until replaced following a subsequent certification.

Purpose: Marking compartments and covers permits ready access to the respirators in the event of an emergency. Additionally, certification of inspection records provides assurance to workers that emergency-use respirators will operate properly when needed.

E. Breathing air quality and use (§1910.134(i))

This paragraph requires the employer to provide workers using atmosphere-supplying respirators (supplied-air and SCBA) with breathing gases of high purity.

§1910.134(i)(4)(ii) - Cylinders of purchased breathing air have a certificate of analysis from the supplier that the breathing air meets the requirements for Grade D breathing air; and

§1910.134(i)(5)(iv) - Have a tag containing the most recent change date and the signature of the person authorized by the employer to perform the change. The tag shall be maintained at the compressor.

Purpose: The certificate of analysis assures workers and employers that the purchased breathing air used in atmosphere-supplying respirators is safe. In addition, the tag requirement provides assurance to workers and employers that sorbent beds and filters are functioning properly to remove hazardous substances from the air produced by compressors for atmosphere-supplying respirators.

F. Training and information (§1910.134(k))

This paragraph requires the employer to provide effective training to workers who are required to use respirators. The training must be comprehensive, understandable, and recur annually, and more often if necessary. This paragraph also requires the employer to provide the basic information on respirators in Appendix D of this section to workers who wear respirators when not required by this section or by the employer to do so.⁶

§1910.134(k)(1) - The employer shall ensure that each employee can demonstrate knowledge of at least the following:

§1910.134(k)(1)(i) - Why the respirator is necessary and how improper fit, usage, or maintenance can compromise the protective effect of the respirator;

§1910.134(k)(1)(ii) - What the limitations and capabilities of the respirator are;

§1910.134(k)(1)(iii) - How to use the respirator effectively in emergency situations, including situations in which the respirator malfunctions;

§1910.134(k)(1)(iv) - How to inspect, put on and remove, use, and check the seals of the respirator;

§1910.134(k)(1)(v) - What the procedures are for maintenance and storage of the respirator;

§1910.134(k)(1)(vi) - How to recognize medical signs and symptoms that may limit or prevent the effective use of respirators; and

§1910.134(k)(1)(vii) - The general requirements of this section.

§1910.134(k)(2) - The training shall be conducted in a manner that is understandable to the employee.

§1910.134(k)(3) - The employer shall provide the training prior to requiring the employee to use a respirator in the workplace.

§1910.134(k)(4) - An employer who is able to demonstrate that a new employee has received training within the last 12 months that addresses the elements specified in paragraph (k)(1)(i) through (vii) is not required to repeat such training provided that, as required by paragraph (k)(1), the employee can demonstrate knowledge of those element(s). Previous training not repeated initially by the employer must be provided no later than 12 months from the date of the previous training.

§1910.134(k)(5) - Retraining shall be administered annually, and when the following situations occur:

§1910.134(k)(5)(i) - Changes in the workplace or the type of respirator render previous training obsolete;

§1910.134(k)(5)(ii) - Inadequacies in the employee's knowledge or use of the respirator indicate that the employee has not retained the requisite understanding or skill; or

§1910.134(k)(5)(iii) - Any other situation arises in which retraining appears necessary to ensure safe respirator use.

§1910.134(k)(6) - The basic advisory information on respirators, as presented in Appendix D of this section, shall be provided by the employer in any written or oral format, to employees who wear respirators when such use is not required by this section or by the employer.

Purpose: Training ensures that workers understand that proper fit, use, and maintenance of respirators is critical to proper respirator protection. Inadequate attention to any of the training elements may impair workers’ effective use of respirators.

G. Recordkeeping (§1910.134(m))

This section requires the employer to establish and retain written information regarding medical evaluations, fit testing, and the respirator program. This information will facilitate worker involvement in the respirator program, assist the employer in auditing the adequacy of the program, and provide a record for compliance determinations by OSHA.

Medical evaluation (§1910.134(m)(1))

§1910.134(m)(1) - Records of medical evaluations required by this section must be retained and made available in accordance with 29 CFR 1910.1020.

Fit-Testing (§1910.134(m)(2))

§1910.134(m)(2)(i) - The employer shall establish a record of the qualitative and quantitative fit tests administered to an employee including:

§1910.134(m)(2)(i)(A) - The name or identification of the employee tested;

§1910.134(m)(2)(i)(B) - Type of fit test performed;

§1910.134(m)(2)(i)(C) - Specific make, model, style, and size of respirator tested;

§1910.134(m)(2)(i)(D) - Date of test; and

§1910.134(m)(2)(i)(E) - The pass/fail results for QLFTs or the fit factor and strip chart recording or other recording of the test results for QNFTs.

§1910.134(m)(2)(ii) - Fit test records shall be retained for respirator users until the next fit test is administered.

§1910.134(m)(4) - Written materials required to be retained under this paragraph shall be made available upon request to affected employees and to the Assistant Secretary or designee for examination and copying.

Purpose: Employers may use a worker’s fit-testing records to select specific respirator makes, models, and sizes for subsequent fit testings, thereby avoiding unnecessarily prolonged fit-testing sessions. These records also enable OSHA to determine if: The employer tested a worker prior to initial respirator use, administered the appropriate test, and performed the test correctly; and the worker passed the test and is using the proper respirator model and size.

Making the information ensures that workers have access to information they can use to identify workplace atmospheric hazards and to determine the effectiveness of their employer’s respiratory-protection program.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also, describe any consideration of using information technology to reduce the burden.

Employers may use improved information technology when making, keeping, or preserving the

required records. OSHA wrote the Standard in performance language, i.e., it states what information to collect rather than how to collect it.

4. Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use of the purposes described in Item 2 above.

The information collection requirements in the Standard are specific to each employer and worker involved, and no other source or agency duplicates the requirements or can make the required information available to the Agency (i.e., the required information is available only from employers).

5. If the collection of information impacts small businesses or other small entities, describe any methods used to minimize burden.

The information collection requirements of the Standard do not have a significant impact on a substantial number of small entities.

6. Describe the consequences to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

The information collection frequencies specified by the Standard are the minimum OSHA believes necessary to allow it and employers to evaluate the effectiveness of respiratory-protection programs, especially the health protection afforded by respirator use to workers who work in toxic atmospheres.

7. Explain any special circumstances that would cause an information collection to be conducted in a manner:

· Requiring respondents to report information to the agency more often than quarterly;

· Requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;

· Requiring respondents to submit more than an original and two copies of any document;

· Requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records, for more than three years;

· In connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of study;

· Requiring the use of a statistical data classification that has not been reviewed and approved by OMB;

· That includes a pledge of confidentiality that is not supported by authority established in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or

· Requiring respondents to submit proprietary trade secret, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.

No special circumstances exist that require employers to collect information in the manner or using the procedures specified by this item.

8. If applicable, provide a copy and identify the data and page number of publication in the Federal Register of the agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken by the agency in response to these comments. Specifically address comments received on cost and hour burden.

Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported.

Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every three years -- even if the collection of information activity is the same as in prior periods. There may be circumstances that may preclude consultation in a specific situation. These circumstances should be explained.

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)), OSHA published a notice in the Federal Register on March 14, 2011 (76 FR 13668, Docket No. OSHA-2011-0027) requesting public comment on its proposed extension of the information collection requirements contained in the Respiratory Protection Standard at 29 CFR 1910.134 (the “Standard”). This notice was part of a preclearance consultation program intended to provide those interested parties the opportunity to comment on OSHA’s request for an extension by the Office of Management and Budget (OMB) of a previous approval of the information collection requirements found in the Standard. The Agency received no comments in response to its notice to comment on this request.

9. Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.

The Agency will not provide payments or gifts to the respondents.

10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy.

OSHA considers the medical records required by the Standard to be confidential. To ensure that these records remain confidential, the Agency implemented §1913.10, which governs its access to worker medical information.

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

None of the provisions in the Standard require an employer to collect sensitive information.

12. Provide estimates of the hour burden of the collection of information. The statement should:

· Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hours for customary and usual business practices.

· If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens.

· Provide estimates of annualized costs to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories.

Burden Hour and Cost Determinations

The following sections summarize the methodology used for estimating the number of burden hours and costs resulting from the information collection requirements of the Standard.

Wage Rates

The Agency adopted the mean wage rates from “Employer Costs for Employee Compensation, September 2010,” U.S. Department of Labor, Bureau of Labor Statistics (http://stats.bls.gov/home.htm, page 10). Total compensation for these occupational categories includes an adjustment for fringe benefits. On average, fringe benefits represent 29.4 percent (Ibid, page 3) of total hourly compensation in the private sector. The total hourly compensation costs of labor used in this analysis are:

Supervisor $49.31

Worker (Employee) $27.88

Secretary $22.00

(A) Respiratory Protection Program (§1910.134(c))

The Standard requires employers to develop and maintain a written respiratory-protection program. The Final Economic Analysis (FEA) for the Standard estimates that small and large firms take 4 and 8 hours, respectively, to develop the written program. Of the estimated 618,804⁷ employers covered by the Standard in 2007, OSHA believes that each year 12.6%⁸ (77,969) are new employers who must develop new programs. The Agency assumes that 98% (76,410) of the new employers are small firms,⁹ and that the remaining 2% (1,559) are larger employers. The Agency assumes a supervisor will develop the written program. Therefore, the total annual burden hours and cost for both employer groups to develop and maintain a written respiratory-protection program are:

Burden hours: (76,410 x 4 hours) + (1,559 x 8 hours) = 318,112 hours

Cost: 318,112 hours x $49.31 = $15,686,103

Existing employers¹⁰ must update their programs to accommodate changes in workplace conditions that affect respirator use. OSHA assumes that 20% of existing employers (108,167) update their programs every year, and that supervisors for small firms (108,167 x 98% = 106,004 firms) would take 2 hours, and supervisors for larger firms (108,167 x 2% = 2,163 firms) would take 4 hours, to update the programs. The annual burden hour and cost estimates for existing employers to update their programs are:

Burden hours: (106,004 x 2 hours) + (2,163 x 4 hours) = 220,660 hours

Cost: 220,660 hours x $49.31 = $10,880,745

Total burden hours and costs for new and existing employers to develop their programs are:

Total burden hours: 318,112 hours + 220,660 hours = 538,772 hours

Total cost: $15,686,103 + $10,880,745 = $26,566,848

(B) Medical Evaluation (§1910.134(e))

Paragraph (e)(2) of the Standard specifies that employers must medically evaluate workers prior to fit testing and initial respirator use. A PLHCP must perform medical evaluations using a medical questionnaire or an initial medical examination. The Agency estimates that a worker takes 15 minutes (.25 hour) to complete the questionnaire. Based on assumptions used in the 2001 NIOSH/BLS survey of respirator use and practices and employment data from the U.S. Census Bureau’s County Business Patterns survey, it is estimated that in 2007 the Standard covered 4,965,000 workers.¹¹ The 2009 BLS Job Openings and Labor Turnover survey estimated an average total separations rate of 46.2%¹² in industries covered by the Standard. The burden hours and cost to administer the questionnaire to the 2,293,830 (4,965,000 x 46.2%) new workers (with an hourly wage rate of $27.88) each year are:

Burden hours: 2,293,830 questionnaires x .25 hour = 573,458 hours

Cost: 573,458 hours x $27.88 = $15,988,009

According to paragraph (e)(3) of the Standard, employers must provide follow-up medical examinations to workers who respond positively to specific items in the questionnaire (or to the initial medical examination). OSHA estimates that 23%¹³ of the 2,293,830 new workers (527,581) require follow-up medical examinations each year, and that it takes 1 hour for them to receive a follow-up medical examination. Therefore, the annual burden hours and cost of this provision are:

Burden hours: 527,581 workers x 1 hour = 527,581 hours

Cost: 527,581 hours x $27.88 = $14,708,958

Paragraph (e)(5) of the Standard requires employers to provide PLHCPs with information about a worker’s respirator and work conditions before the PLHCP makes a recommendation concerning a worker’s eligibility to use the respirator. Employers provide this information to PLHCPs prior to a worker’s initial medical evaluation and any additional medical examination.¹⁴ OSHA estimates that employers provide 2,293,830 initial medical evaluations and 248,250 additional medical evaluations each year and that, for each medical evaluation, a secretary takes 15 minutes (.25 hour) to compile the required information and provide it to the PLHCP. Accordingly, each year the burden hours and cost of this requirement are:

Burden hours: 2,542,080 medical evaluations x .25 hour = 635,520 hours

Cost: 635,520 hours x $22.00 = $13,981,440

Paragraph (e)(7) of the Standard requires employers to provide an additional medical evaluation to workers under specific conditions. However, the Agency believes that most workers who use respirators do not need additional medical evaluations. Therefore, OSHA assumes that 5% of all workers (5% x 4,965,000 = 248,250) will require additional medical evaluations each year, and that each of these workers takes .50 hour to undergo the additional medical evaluation. The yearly burden hours and cost of this provision are:

Burden hours: 248,250 workers x .50 hour = 124,125 hours

Cost: 124,125 hours x $27.88 = $3,460,605

Total burden hours and costs for administering the initial medical evaluations, follow-up medical examinations, and additional medical evaluations, as well as providing supplemental information to the PLHCPs, are:

Total burden hours: 573,458 hours + 527,581 hours + 635,520 hours + 124,125 hours = 1,860,684 hours

Total cost: $15,988,009 + $14,708,958+ $13,981,440 + $3,460,605 = $48,139,012

C. Fit testing (§1910.134(f))

Based on percentages used in the FEA, of the 4,965,000 workers currently covered by this provision, 13% (645,450) received annual fit tests when the standard became effective. Therefore, the additional paperwork requirement associated with annual fit testing applies only to the remaining 87% (4,319,550). From percentages used in the FEA, OSHA finds that outside contractors provide quantitative fit tests to 8% (345,564) of the remaining workers, while respirator manufacturers administer qualitative fit tests to about 20% (863,910) of these workers at no cost to their employers, and employers conduct in-house fit testing on the final group of 3,110,076 workers. The Agency believes that each worker takes about 30 minutes (.50 hour) to complete a fit test, and that a supervisor requires about 30 minutes (.50 hour) to administer an in-house fit test. The annual burden hour and cost estimates for fit testing are:

Quantitative Fit Testing by Outside Contractors

Burden hours: 345,564 tests x .50 hour (worker time) = 172,782 hours

Cost: 172,782 hours x $27.88 = $4,817,162

Qualitative Fit Testing by Respirator Manufacturers

Burden hours: 863,910 tests x .50 hour (worker time) = 431,955 hours

Cost: 431,955 hours x $27.88 = $12,042,905

In-House Fit Testing by Supervisors

Burden hours: Supervisors: 3,110,076 tests x .50 hour = 1,555,038 hours

Workers: 3,110,076 tests x .50 hour = 1,555,038 hours

Total: 1,555,038 hours + 1,555,038 hours = 3,110,076 hours

Cost: Supervisors: 1,555,038 hours x $49.31 = $76,678,924

Workers: 1,555,038 hours x $27.88 = $43,354,459

Total: $76,678,924 + $43,354,459 = $120,033,383

Total burden hours and costs for fit testing by outside contractors, respirator manufacturers, and in-house supervisors are:

Total burden hours: 172,782 hours + 431,955 hours + 3,110,076 hours = 3,714,813 hours

Total cost: $4,817,162 + $12,042,905 + $120,033,383 = $136,893,450

D. Maintenance and care of respirators (§1910.134(h))

Storing and marking emergency-use respirators (§1910.134(h)(2)(ii)(B))

This provision requires employers to store emergency-use respirators in compartments or protective covers and clearly mark the compartments or covers to indicate that they contain emergency-use respirators. The FEA estimated that approximately 2% of the employers who use respirators must comply with this marking requirement; hence, out of the total number of employers who use respirators (618,804) 12,376 would be affected by the provision. OSHA assumes that 10% of these employers (1,238) are new employers who are complying with this provision for the first time, and that each of these employers marks an average of two emergency-use respirators, for a total of 2,475 respirators. In addition, the Agency estimates that a worker takes 5 minutes (.08 hour) to mark a storage compartment or protective cover for each respirator. Therefore, the annual burden-hour and cost estimates for this requirement are:

Burden hours: 2,475 respirators x .08 hour = 198 hours

Cost: 198 hours x $27.88 = $5,520

Certification of inspection records for emergency-use respirators (§1910.134(h)(3)(iv)(A) and (h)(3)(iv)(B))

Employers must inspect emergency-use respirators at least monthly and then certify, in writing, the inspection records for these respirators. OSHA estimates that a worker takes 10 minutes (.17 hour) to perform the inspection and to complete the written certificate (e.g., enter the required inspection information on a tag or label attached to the compartment used to store the respirator). As noted in the previous section, the Agency determined that 12,376 employers each have 2 emergency-use respirators (for a total of 24,752 respirators). Accordingly, the yearly burden-hour and cost estimates for this provision are:

Burden hours: 24,752 respirators x 12 inspections/year x .17 hour = 50,494 hours

Cost: 50,494 hours x $27.88 = $1,407,773

E. Breathing air quality and use (§1910.134(i))

Certificate of analysis for cylinders (§1910.134(i)(4)(ii))

The Agency believes that it is the usual and customary practice among suppliers of purchased breathing air to provide employers with the required certificate when they purchase the breathing air. Therefore, OSHA is taking no burden for this requirement.

Sorbent beds and filters (§1910.134(i)(5)(iv))

The Agency assumes that employers make 3 sorbent-bed and filter changes on each air compressor annually. OSHA estimates that the requirement to maintain a tag on each compressor displaying the required change information applies to 24,554 compressors¹⁵, and that a worker takes 5 minutes (.08 hour) to enter this information on a tag. Therefore, the annual burden hours and cost of this provision are:

Burden hours: 24,554 compressors x 3 changes/year x .08 hour = 5,893 hours

Cost: 5,893 hours x $27.88 = $164,297

(F) Training and information (§1910.134(k))

This provision requires employers to provide workers with specific knowledge and skills, and to retrain them under defined conditions. Employers can comply with this provision by reviewing with the worker, orally or using written material, the information provided under the training program and how the worker uses the respirator.

With the exception of § 1910.134(k)(6), OSHA believes that this provision is performance oriented because employers assess workers’ knowledge and skills by observing how they use respirators; in addition, the provision does not specify an hourly training requirement, require training records, training format, or how the employer is to conduct the training. Therefore, the Agency incurs no burden hours or cost for these information collection requirements in this Supporting Statement.

OSHA considers the requirement in § 1910.134(k)(6) that employers provide Appendix D to workers to be a public disclosure of information originally supplied by the Federal government to the employer for the purpose of disclosure to the public. Additionally, the Agency considers the requirement in Appendix D that workers engaged in voluntary respirator use “read and heed” instructions provided by the respirator manufacturer to be a usual and customary practice in these industries. Therefore, OSHA is taking no burden hours for this requirement.

(G) Recordkeeping (§1910.134(m))

Medical-Evaluation Records (§1910.134(m)(1))

Employers must maintain the medical-evaluation records required by the Standard in accordance with 29 CFR 1910.1020. For purposes of estimating the burden hours and cost imposed by this recordkeeping provision, the Agency assumed that each medical procedure (i.e., initial medical evaluation, follow-up medical examination, and additional medical evaluation) resulted in a record. Based on the determinations made under section (B) above, OSHA finds that employers must maintain 3,069,661 medical records each year (i.e., 2,293,830 initial medical evaluations + 527,581 follow-up medical examinations + 248,250 additional medical evaluations). In addition, the Agency estimates that a secretary takes 5 minutes (.08 hour) to maintain each medical record. Accordingly, the annual burden hours and cost of this recordkeeping requirement are:

Burden hours: 3,069,661 records x .08 hour = 245,573 hours

Cost: 245,573 hours x $22.00 = $5,402,606

Respirator Fit-Testing Records (§1910.134(m)(2))

The fit-testing provisions of the Standard require employers to establish and maintain a record of the qualitative and quantitative fit tests administered to workers. As noted under section (C) above, employers collect 4,319,550 fit-testing records annually. OSHA estimates that a secretary spends 5 minutes (.08 hour) annually establishing and maintaining each of these records. The burden hours and cost associated with this provision are:

Burden hours: 4,319,550 records x .08 hour = 345,564 hours

Cost: 345,564 hours x $22.00 = $7,602,408

Employee Access (§1910.134(m)(4))

OSHA assumes that each year 10% of the workers subject to the medical-evaluation provisions of the Standard make a request to review their medical records. The Agency believes that a secretary takes 5 minutes (.08 hour) to process each of these requests. Therefore, this provision results in the following burden hours and cost:

Burden hours: 4,965,000 workers x 10% x .08 hour = 39,720 hours

Cost: 39,720 hours x $22.00 = $873,840

13. Provide an estimate of the total annual cost burden to respondents or recordkeepers resulting from the collection of information. (Do not include the cost of any hour burden shown in Items 12 and 14.)

· The cost estimate should be split into two components: (a) a total capital and start-up cost component (annualized over its expected useful life) and (b) a total operation and maintenance and purchase of services component. The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information. Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life on capital equipment, the discount rate(s), and the time period over which costs will be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities.

· If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance. The cost of purchasing or contracting out information collections services should be part of this cost burden estimate. In developing cost burden estimates, agencies may consult with a sample of respondents (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate.

· Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.

The total cost for employers to provide medical examinations and fit testing is $185,578,935, determined as follows:

Medical Examinations

Assuming that each medical examination costs $294.75¹⁶, the total cost of administering the medical examinations (see section (B) above (§1910.134(e)(3)) is $155,504,500 (527,581 medical examinations x $294.75).

Fit-Testing Materials

As noted under section (C) above, employers administer in-house fit tests to 3,110,076 workers each year. Estimating that the materials for each fit test cost $1.15¹⁷, OSHA determined that the total cost of these materials is $3,576,587 (3,110,076 tests x $1.15).¹⁸

Quantitative Fit Tests

Section (C) above shows that contractors administer quantitative fit tests to 345,564 workers. Having determined that the price of each of these fit tests is $76.68¹⁹, the Agency found that the total cost of this testing was $26,497,848 (345,564 tests x $76.68).

14. Provide estimates of annualized cost to the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information. Agencies may also aggregate cost estimates from Items 12, 13, and 14 in a single table.

The Agency estimates that a compliance officer (GS-12, step 5), with an hourly rate of $37.37 ²⁰, would spend 10 minutes (.17 hour) during an inspection reviewing the paperwork requirements specified by the Standard, especially medical-evaluation and fit-testing records. OSHA determined that its compliance officers would conduct 8,663 inspections.²¹ The Agency considers other expenses, such as equipment, overhead, and support staff salaries, to be normal operating expenses that would occur without the collection of information requirements specified by the Standard. Therefore, the total cost of these paperwork requirements to the Federal government is:

Cost: 8,663 inspections x $37.37 x .17 hour = $55,035

15. Explain the reasons for any program changes or adjustments.

OSHA is requesting an adjustment decrease to the burden hours of these paperwork requirements from 7,159,601 burden hours to 6,801,710 hours, for a total decrease of 357,891 hours. Table 1 attached describes each of the requested burden hour adjustments.

Otherwise, the cost of medical examinations has increased from $266.50 to $294.75. With 527,581 being performed at $294.75 per examination, the total cost is $155,504,500; this is an increase of $21,154,388. The cost of fit-testing materials has increased from $1.07 to $1.15. With 3,110,076 fit-tests being administered at $1.15, the total cost is $3,576,587; this is a decrease in cost of $50,795, due to the decrease in workers fit-tested. The cost of quantitative tests has increased from $71.08 to $76.68. With 345,564 quantitative examinations being performed at $76.68 per exam, the total cost is $26,497,848; this is a decrease in cost of $276,211, again due to the decrease in workers fit-tested. Accordingly, the total estimated cost for operation and maintenance is $185,578,935.

16. For collection of information whose results will be published, outline plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.

OSHA will not publish the information collected under the Standard.

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.

There are no forms on which to display the expiration date.

18. Explain each exception to the certification statement.

OSHA is not seeking such an exception.

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS     

This Supporting Statement does not contain any collection of information requirements that employ statistical methods.

Table 1

Description of Requested Burden-Hour Adjustments

Information Collection Requirement	Responses	Current Burden Hours	Requested Burden Hours	Burden Hour Change	Estimated Cost	Description of Change
Respiratory Protection Program	186,136	533,414	538,772	5,358	$26,566,848.00	There is an increase in burden hours due to the increase in new employers developing new programs (from 74,196 to 77,969), as a result of using the Bureau of Labor Statistics, Longitudinal Business Database (1977-2005) instead of U.S. Census data for this estimate.
Medical Evaluation
Medical Evaluation: Initial Medical Evaluations, Follow-up Medical Examinations, Additional Medical Evaluations, and Information Provided to the PLHCP	5,611,741	1,861,390	1,860,684	-706	$48,139,012.00	The decrease in burden hours is due to the lower number of covered workers (from 5,412,000 to 4,965,000) overall, a total decrease of 447,000 covered workers. The lower number of covered workers is a result of using 2007 U.S. Census economic data instead of 2005 County Business Pattern (CBP) data. Also, the decrease in burden hours is affected by the increase in the separations rate or job turnover rate (from 40.5% to 46.2%), which results in a higher number of new employees.
Fit Testing
Fit Testing	7,429,626	4,049,260	3,714,813	-334,447	$136,893,450.00	See above.
Maintenance and Care of Respirators:
Storing and Marking Emergency-Use Respirator	2,475	205	198	-7	$5,520.00	The overall number of employers covered by the standard decreased from 639,623 to 618,804 as a result of using 2007 U.S. Census economic data instead of 2005 County Business Pattern (CBP) data. This is a decrease of 20,819 in establishments covered by the regulation.
Certification of Emergency-Use Respirator	297,024	52,195	50,494	-1,701	$1,407,773.00	See above.
Breathing air quality and use
Certificate of Analysis of Cylinders	0	0	0	0	$0.00
Sorbent Beds and Filters	73,662	5,839	5,893	54	$164,297.00	The 54 hour increase is due to the use of 2007 U.S. Census economic data instead of 2005 County Business Pattern (CBP) data. (See footnotes 11 and 15.)
Training and Information	0	0	0	0	$0.00	OSHA is not taking burden hours for employers to retain training records since OSHA does not require or request such records.
Recordkeeping
Medical-Evaluation Records	3,069,661	237,327	245,573	8,246	$5,402,606.00	Although there is a lower number of total covered workers (from 5,412,000 to 4,965,000), the burden hours increased as a result of the increase in the separations rate or job turnover rate (from 40.5% to 46.2%), which results in a higher number of new employees.
Fit-Testing Records	4,319,550	376,675	345,564	-31,111	$7,602,408.00	See above.*
Employee Access	496,500	43,296	39,720	-3,576	$873,840.00	See above.*
TOTALS	21,486,375	7,159,601	6,801,711	-357,890	$227,055,754.00
* There was an administrative error in the previous ICR Table I; however, the administrative error did not result in erroneous burden or cost estimates.

1 The purpose of this Supporting Statement is to analyze and describe the burden hours and costs associated with provisions of the Respiratory Protection Standard that contain paperwork requirements; this Supporting Statement does not provide information or guidance on how to comply with, or how to enforce, this Standard.

2 This Standard applies to general industry, construction, shipyard, longshoring, and marine-terminal workplaces.

3 The burden for maintaining copies of written programs (see paragraph (m)(3) of the Standard) includes the requirement to update the programs.

4 In accordance to §1910.134(e)(5)(ii), any supplemental information provided previously to the PLHCP regarding a worker need not be provided for a subsequent medical evaluation if the information and the PLHCP remain the same.

5 After a fit test, employers must record the worker’s name, the date of the fit test, and the type, brand, and size of the respirator in accordance with paragraph (m)(3) of the Standard. These records ensure that: respirator users receive the proper fit test; the respirators selected are appropriate for the atmospheric hazards they encounter; and the respirator users receive annual retesting.

6 Employers must provide Appendix D, “Information for Employees Using Respirators When Not Required Under the Standard” to workers using respirators voluntarily. Appendix D requires employees to: “Read and heed all instructions provided by the manufacturer on use, maintenance, cleaning and care, and warnings regarding the respirators [sic] limitations.”

7 Source: Respirator Usage in Private Sector Firms, 2001. U.S. Department of Labor, Bureau of Labor Statistics (BLS) and the National Institute for Occupational Safety and Health (NIOSH). September 2003. Text Table 1: “Number and percent of establishments using respirators, by selected type of use and industry division.” OSHA used this information to determine the percentage of establishments that were using respirators in each industry in 2001. These percentages were applied to the 2007 U.S. Census economic data (the latest available as of February 2011) to determine the total number of establishments within each industry division using respirators in 2007.

8 The U.S. Department of Labor, Bureau of Labor Statistics, Longitudinal Business Database 1977-2005.

9 Small firms are defined as those employers employing less than 500 employees per facility.

10 Existing employers do not include the 77,969 employers who have developed new initial written respirator programs.

11 OSHA calculated the change in total employment for each industry division by comparing the employment numbers in the 2007 U.S. Census economic data to those in the Respirator Usage in Private Sector Firms, 2001. U.S. Department of Labor, Bureau of Labor Statistics (BLS) and the National Institute for Occupational Safety and Health (NIOSH). September 2003. The results showed a 0.7% (0.007) overall decline in employment. This 0.7% decrease represents the change in employment for the relevant industries between 2001 and 2007. Thus, it was applied to the estimate of affected workers contained in the 2001 ICR to determine updated employment figures (5,000,000 x (1-.007) = 4,965,000).

12 Source: BLS Job Openings and Labor Turnover 2009, total separations rate for the private industry, not seasonally adjusted.

13 The FEA initially estimated that 23% of the employees receiving an initial medical evaluation would need a follow-up medical examination. Accordingly, OSHA is applying this percentage to the total number of new employees covered by the Standard.

14 Employers do not need to provide supplemental information regarding a worker to the PLHCP for subsequent medical evaluations when the information and the PLHCP are the same. Therefore, employers would rarely provide this information to a PLHCP when a worker receives a follow-up examination because the PLHCP usually receives the information prior to the initial medical evaluation.

15 OSHA assumes that compressors are used in supplied air respirators and that the number of compressors declined at the same rate as total employment. The decline in total employment was calculated by comparing the Respirator Usage in Private Sector Firms, 2001,. U.S. Department of Labor, Bureau of Labor Statistics (BLS) data to the US Census 2007 economic data. Hence, the -0.7% change is the change from 2001 to 2007 (see footnote 11). OSHA has updated the value contained in the 2001 ICR to update this 0.7% decline (24,727 x (1-.007) = 24,554).

16 The previous ICR assumed that each medical examination cost $250. The Consumer Price Index (CPI) indicated a 17.9% increase in the price of professional medical services from 2004 to 2010; the cost of a medical examination was assumed to have increased by 17.9% as well.

17 The previous ICR assumed that materials for each fit test cost $1.00. Given an increase in the overall CPI of 15% from 2004 to 2010, it was assumed that the cost of materials increased by 15% as well.

18 OSHA is not including the cost of administering qualitative fit tests as a capital expense because respirator manufacturers provide this service at no cost to employers with the purchase of their respirators.

19 The previous ICR determined that the price of quantitative fit test was $66.68. Given an increase in the overall CPI of 15% from 2004 to 2010, it was assumed that the cost of quantitative fit tests increased by 15% as well.

20 Source: U.S. Office of Personnel Management, General Schedule and Locality Tables, Salary Table 2010-RUS, http://www.opm.gov/oca/10tables/pdf/rus_h.pdf.

21 OSHA estimated the number of inspections by determining an overall inspection rate of 1.4% (0.014) for all employers under its jurisdiction, then applying this percentage to the number of employers (618,804) covered by the Standard.

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