Document ID: OSHA-2011-0196-0013
Agency: osha
Document Type: Supporting & Related Material
Title: 
Posted Date: 2021-04-08T04:00Z

SUPPORTING STATEMENT FOR THE
                    INFORMATION COLLECTION REQUIREMENTS IN
                THE VINYL CHLORIDE STANDARD (29 CFR 1910.1017) 
                       OFFICE OF MANAGEMENT AND BUDGET 
                  (OMB) CONTROL NO. 1218-0010 (April 2021) F
                                                      
This ICR is requesting an extension to its currently approved collection of data. 

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." As one means in achieving this objective, the Act specifically authorizes "the development and promulgation of occupational safety and health standards" to ensure that employees will be furnished "employment and a place of employment . . .  free from recognized hazards that are causing or likely to cause death or serious physical harm."

For toxic substances, the OSH Act contains specific statutory language.  Thus, as appropriate, health standards are required to include provisions for monitoring and measuring employee exposure, medical examinations and other tests, control and other technological procedures, suitable protective equipment, labels and other appropriate forms of warning, and precautions for safe use or exposure (paragraph (6)(b)(7)).  In addition, the OSH Act specifically mandates issuing "regulations requiring employers to maintain accurate records of employee exposures to potentially toxic materials or other harmful physical agents which are required to be monitored and measured," and further requires that employees exposed to concentrations over prescribed limits be notified of this fact, and of the corrective action being taken (paragraphs (8)(c)(1) and (c)(3)). 

Pursuant to its statutory authority, the Occupational Safety and Health Administration (OSHA) published a health standard governing worker exposure to vinyl chloride (VC) and polyvinyl chloride (PVC) (29 CFR 1910.1017).  

VC is a flammable gas at room temperature.  It is usually encountered as a cooled liquid.  The colorless liquid forms a vapor that has an ethereal odor.  VC may be used as a vinyl monomer in the manufacture of PVC and other resins, as a chemical intermediate, or as a solvent.  Vinyl chloride gas is absorbed by inhalation; skin absorption has also been suggested.  Chronic exposure to VC may cause cancer in a variety of organs, including liver, lung, brain, and kidney.

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.

Exposure Monitoring (§ 1910.1017(d))
      
Employers must perform initial monitoring to determine the extent of VC exposure in their workplace.  Initial monitoring assists employers in identifying areas of operation that may require additional efforts to reduce worker exposure and to come into compliance with the standard.  Initial monitoring results also assist employers in determining the necessity for using engineering controls, instituting or modifying work practices, and in selecting appropriate respiratory protection to prevent workers from overexposure.  If the initial monitoring exceeds the standard's action level, then the employer must conduct periodic monitoring.  

Subparagraphs 1910.1017(d)(2)(i) and (d)(2)(ii) require that employers conduct exposure monitoring at least quarterly if the results of initial exposure monitoring show that worker exposures are above the PEL, and no less than semiannually if these results indicate exposures that are at or above the action level. 

Periodic monitoring is appropriate because minor changes in process, materials, or environmental conditions might change the VC airborne concentration levels.  By using periodic monitoring, employers can evaluate the effectiveness of selected control methods.  In addition, these measurements remind both the employer and workers of the continuing need to protect against the hazards that could result from workers' overexposure.

Subparagraph 1910.1017(d)(3) requires employers to conduct additional monitoring whenever there has been a production, process or control change which may result in an increase in the release of vinyl chloride, or the employer has any other reason to suspect that any employee may be exposed in excess of the action level.  Such monitoring ensures that work areas are safe, or alerts the employer that protection may still be needed.  Also, exposure monitoring will inform the examining physician about the existence and extent of potential hazards.

Written Compliance Plan (§§ 1910.1017(f)(2) and (f)(3))

Employers must establish and implement a written compliance plan when workers are exposed above the VC permissible exposure limit (PEL).  Employers must review and/or revise the compliance plan at least annually, to describe the program's current status.  The compliance plan must describe the methods the employer will use to reduce worker exposure to, or below, the PEL in their workplace.  The purpose of requiring an employer to establish a written compliance plan is to effectively promote required compliance with the standard's PEL.

This requirement commits the employer to evaluating workers' exposures and developing an organized and complete plan of reducing worker exposure to the PEL. There may be cases when the employer cannot immediately institute the engineering and work practice controls required by the standard, and must instead use respiratory protection as an interim measure.  The requirement to prepare and update a compliance plan ensures that exposure-control methods are planned on a continuing basis, and revised as necessary.

Respiratory Program (§ 1910.1017(g)(2))

When respirators are required, the employer must establish a respiratory protection program in accordance with §1910.134, paragraphs (b) through (d) (except (d)(1)(iii) and (d)(3)(iii)(B)(1) and (2)) and (f) through (m).  Paragraph 1910.134(c) requires the employer to develop and implement a written respiratory protection program with worksite-specific procedures and elements for respirator use.  The purpose of these requirements is to ensure that employers establish a standardized procedure for selecting, using, and maintaining respirators for each workplace where respirators will be used.  Developing written procedures ensures that employers develop a respirator program that meets the needs of their workers.

Emergency Plan (§ 1910.1017(i))

Employers must develop a written operational plan for dealing with emergencies; the plan must address the storage, handling, and use of VC as a liquid or compressed gas.  In the event of an emergency, appropriate elements of the plan must be implemented.  Emergency plans must maximize workers' personal protection and minimize the hazards of an emergency. 

Medical Surveillance (§ 1910.1017(k))

Medical Examinations--(k)(1), (2), and (3)

Employers must provide initial examinations for each worker exposed in excess of the action level.  Medical examinations must be provided in accordance with paragraph (k) at least annually.  Each worker exposed to an emergency must also be afforded appropriate medical surveillance. 

Medical examinations and the related information collection requirements provide for periodic monitoring of worker health.  Medical exam records are used by physicians who must examine workers exposed to VC.  Without records of previous medical examinations, the physician may not be able to determine whether workers have experienced adverse health effects since their last examination.  Further, when symptoms of organic damage appear, the physician often needs information about the patient's previous medical conditions to make an accurate diagnosis of the new problem, its apparent cause, and the course of treatment required.  Medical records also ensure that workers can determine whether or not treatment or other interventions are needed for occupational exposures.  The long-term maintenance of medical for records is necessary because of the lengthy latency periods associated with the manifestation of health effects caused by VC exposure.
Physician's Written Opinion--(k)(4)

Employers must promptly obtain a statement from the examining physician of each worker's suitability for continued exposure to VC, including the use of personal protective equipment and respirators.  A copy of this statement must be provided to the worker. 

The purpose of requiring the employer to obtain a written opinion from the examining physician is to provide the employer with medical information to aid in determining the initial placement of workers, and to assess a worker's ability to use protective clothing and equipment.  The physician's opinion will also provide information to the employer about whether the worker may be suffering from over exposure to VC.  The requirement that a physician's opinion be written will ensure that the information is properly memorialized.  The requirement that workers be provided with a copy of the physician's written opinion will ensure that they are informed of the results of the medical examination so that they can assist in determining the need for, and evaluate the effectiveness of, treatment or other interventions.

Communication of VC Hazards (§ 1910.1017(l))
 (1) Hazard communication -- general. The employer shall include vinyl chloride and polyvinyl chloride in the program established to comply with the Hazard Communication Standard (HCS) (§ 1910.1200). The employer shall ensure that each employee has access to labels on containers of chemicals and substances associated with vinyl and polyvinyl chloride and to safety data sheets, and is trained in accordance with the provisions of HCS and paragraph (l) of this section. The employer shall ensure that at least the following hazard is addressed: Cancer, central nervous system effects, liver effects, blood effects, and flammability.
(2) Signs. (i) The employer shall post entrances to regulated areas with legible signs bearing the legend:
                                    DANGER
                                VINYL CHLORIDE
                               MAY CAUSE CANCER
                           AUTHORIZED PERSONNEL ONLY
(ii) The employer shall post signs at areas containing hazardous operations or where emergencies currently exist. The signs shall be legible and bear the legend:
                                    DANGER
                                VINYL CHLORIDE
                               MAY CAUSE CANCER
       WEAR RESPIRATORY PROTECTION AND PROTECTIVE CLOTHING IN THIS AREA
                           AUTHORIZED PERSONNEL ONLY
(iii) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (l)(2)(i) of this section:
                           CANCER-SUSPECT AGENT AREA
                           AUTHORIZED PERSONNEL ONLY
(iv) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (l)(2)(ii) of this section:
                       CANCER-SUSPECT AGENT IN THIS AREA
                        PROTECTIVE EQUIPMENT REQUIRED 
                           AUTHORIZED PERSONNEL ONLY
Posting warning signs serves to warn workers that they are entering a hazardous area.  Such signs warn workers that entry is permitted only if they are authorized to do so, and there is a specific need to enter the area.  Warning signs also supplement the training workers receive under this standard.
(3) Labels.  In addition to the other requirements in this paragraph (l), the employer shall ensure that labels for containers of polyvinyl chloride resin waste from reactors or other waste contaminated with vinyl chloride are legible and include the following information:
                       CONTAMINATED WITH VINYL CHLORIDE
                               MAY CAUSE CANCER
(ii) Prior to June 1, 2015, employers may include the following information on labels of containers of polyvinyl chloride resin waste from reactors or other waste contaminated with vinyl chloride in lieu of the labeling requirements in paragraphs (l)(3)(i) of this section:
                       CONTAMINATED WITH VINYL CHLORIDE
                             CANCER-SUSPECT AGENT
(4) Prior to June 1, 2015, employers may include the following information for containers of polyvinyl chloride in lieu of the labeling requirements in paragraphs (l)(1)(i) of this section:
                      POLYVINYL CHLORIDE (OR TRADE NAME) 
                                   Contains
                                VINYL CHLORIDE 
                   VINYL CHLORIDE IS A CANCER-SUSPECT AGENT
(5)(i) Prior to June 1, 2015, employers may include either the following information in either paragraph (l)(5)(i) or (l)(5)(ii) of this section on containers of vinyl chloride in lieu of the labeling requirements in paragraph (l)(1)(i) of this section:
                                VINYL CHLORIDE
                    EXTREMELY FLAMMABLE GAS UNDER PRESSURE
                             CANCER-SUSPECT AGENT
(ii) In accordance with 49 CFR parts 170-189, with the additional legend applied near the label or placard:
                             CANCER-SUSPECT AGENT
(6) No statement shall appear on or near any required sign, label, or instruction which contradicts or detracts from the effect of any required warning, information, or instruction.
Records (§ 1910.1017(m))

Exposure Monitoring and Medical Records--(i), (ii), and (iii)
      
Employers must maintain worker exposure and medical records, and  must provide them upon request to employees, designated representatives, and the Assistant Secretary in accordance with 29 CFR 1910.1020(a) through (e) and (g) through (i). Monitoring records shall be maintained for not less than 30 years. Medical records shall be maintained for the duration of the employment of each employee plus 20 years, or 30 years whichever is longer.

 Medical and monitoring records are maintained principally for worker access, but are designed to provide valuable information to both workers and employers.  The medical and monitoring records required by this standard will aid workers and their physicians in determining whether or not treatment or other interventions are needed for VC exposure.  The information also will enable employers to better ensure that workers are not being over exposed; such information may alert the employer that steps must be taken to reduce VC exposures.

Exposure records must be maintained for at least 30 years, and medical records must be kept for the duration of employment plus 20 years, or for a total of 30 years, whichever is longer. 
Records must be kept for extended periods because of the long latency associated with VC-related carcinogenesis (i.e., cancer).  Cancer often cannot be detected until 20 or more years after the first exposure to VC. 

OSHA would only review records in the context of an investigation of a particular employer to determine compliance with the Standard.  These activities are outside the scope of the PRA.  See 5 CFR 1320.4(a)(2).

While National Institute of Occupational Safety and Health (NIOSH) may use records collected from employers for research purposes, the Agency does not anticipate that NIOSH will request employers to make available records during the approval period.  Therefore, the burden for the employer to make this information available to NIOSH is zero.

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 burden.

Employers may use automated, electronic, mechanical, or other technological information collection techniques, or other forms of information technology (e.g., electronic submission of responses) when establishing and maintaining the required records.  The Agency wrote the paperwork requirement of the provision in performance-oriented language (i.e., in terms of what data to collect, not how to record the data.)	

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

The requirement to collect and maintain information is specific to each employer and worker involved, and no other source or agency duplicates these requirements or can make the required information available to OSHA (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 specified by the Standard do not have a significant impact on a substantial number of small entities. 

6.  Describe the consequence 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 Agency believes that the information collection frequencies required by the Standard are the minimum frequencies necessary to effectively monitor the exposure and health status of workers exposed to VC, and thereby fulfill its mandate "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" as specified by the OSH Act at 29 U.S.C. 651.  Accordingly, if employers do not perform the required information collections, or delay in providing this information, workers will have an increased probability of developing cancer because of their VC exposures.  

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 statistical data classification that has not been reviewed and approved by OMB;

 that includes a pledge of confidentially 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 confidentially to the extent permitted by law.

If exposure monitoring indicates that a worker has been exposed above the PEL, regardless of whether or not respirators are used, employers must notify the worker in writing (or by posting the results in an appropriate location) of the exposure-monitoring results, and the steps being taken to reduce the exposure to within the PEL. This notification must be provided to the worker within 15 working days.

8.  If applicable, provide a copy and identify the date 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 3 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 (PRA) (44 U.S.C. 506(c)(2)(A)), OSHA published a notice in the Federal Register on April 2, 2021 (86 FR 17408) soliciting comments on its proposal to extend the Office of Management and Budget's (OMB) approval of the information collection requirements specified in the Vinyl Chloride Standard (29 CFR 1910.1017), (Docket No. OSHA-2011-0196).  This notice is part of a preclearance consultation program that provides interested parties the opportunity to comment on OSHA's request for an extension by OMB of a previous approval of the information collection requirements found in the above Standard.  The Agency will respond to any substantive comments submitted in response to this notice. 
    
9.  Explain any decision to provide any payments or gifts 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.

As medical records may contain private information, OSHA has taken steps to assure that the medical records' data are kept confidential.  Agency practices and procedures governing OSHA access to worker medical records are contained in 29 CFR 1913.10.

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.

The provisions do not involve collections of 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.  General, 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.
      
 Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories.  The cost of contracting out or paying outside parties for information collection activities should not be included here.  Instead, this cost should be included in Item 13. 

      
             Respondent Burden-Hour and Cost burden Determinations

In the previous version of this ICR, it was estimated that there are 32 vinyl chloride monomer (VC) production facilities and polyvinyl chloride (PVC) polymer production facilities operating in the United States, of which 6 facilities produce both VC and PVC at the same location.  The Agency estimated the number of facilities covered by the standard based on a Vinyl Institute analysis, which stated there are 28 facilities covered by the Standard: 6 produce VC only, 14 produce PVC only, 6 produce both substances, and 2 produce other non-vinyl products. 

OSHA also relied upon the Vinyl Institute's analysis for the purposes of estimating the number of workers in these facilities.  The Vinyl Institute estimated that the 2 plants that produce non-vinyl products each employ 20 workers and that the plants that produce both VC and PVC are more complex and typically have larger employment than the other plants.  Based on this information, and in the absence of other more specific information, the Agency set the employment estimate for the combined plants at 178 employees.  Therefore, OSHA estimates that the number of workers in the affected plants totals 4,528.  The Agency has seen no significant shift in the numbers of affected establishments and employees in publicly available data between the two time periods and, therefore, has retained these estimates from the previous ICR.

The Agency determined the wage rate from mean hourly wage earnings to represent the cost of employee time.  For the relevant standard occupational classification category, OSHA used the wage rates reported in the Bureau of Labor Statistics, U.S. Department of Labor.  Occupational Employment Statistics (OES), May 2019 [date accessed: November 4, 2020].  (OES data is available at https://www.bls.gov/oes/tables.htm.  The Agency is adopting the chemical industry-specific (NAICS 325100) wage rates, as opposed to the more general all-industry "Production Occupations" (SOC code 51-0000) wage rates previously relied on.  The Agency agrees with the Vinyl Institute that the chemical industry-specific wage rates more accurately reflect the wage rates in the affected occupations within the scope of this ICR.

To derive the loaded hourly wage rates presented in the table below, the Agency used data from the Bureau of Labor Statistics' (BLS) Occupational Employment Statistics (OES), as described in the paragraph above. Then, the Agency applied to the wage rate a fringe benefit markup based on Table 2 of the following BLS release: Employer Costs for Compensation news release text released 10:00 AM (EDT), December 17, 2020 (https://www.bls.gov/news.release/ecec.nr0.htm).  BLS reported that for civilian workers, fringe benefits accounted for 31.4 percent of total compensation and wages accounted for the remaining 68.6 percent.  To calculate the loaded hourly wage for each occupation, the Agency divided the mean hourly wage rate by 1 minus the fringe benefits.

                         Table 1- Estimated Wage Rates
                WAGE HOUR ESTIMATES FOR CHEMICAL MANUFACTURING
                              Occupational Title
                           Standard Occupation Code
                             Mean Hourly Wage Rate
                               Fringe Benefits 
                           Loaded Hourly Wage Rate 
                                       
Production Worker Occupations
51-8091
$30.15

.314
$43.95
First-Line Supervisors of Production and Operating Workers
51-1011
$31.35
.314
$45.70
Secretaries and Administrative Assistants
43-6014
$18.84

.314
$27.46
Chemical Technician
19-4031
$25.44
.314
$37.08

	

(A) Exposure Monitoring (§§ 1910.1017(d)(2) and (d)(3))

As in past information collection requests, OSHA assumes that 1% of all workers are exposed between the action level and the permissible exposure level.  OSHA also assumes another 1% of workers have exposures above the PEL. Workers exposed between the action level and the PEL must be monitored semi-annually, while those exposed above the PEL must be monitored quarterly. Also, for the purposes of this clearance, it is assumed that each employer will have one change in production, process, or control method that may result in increased VC exposure; thereby, requiring that an additional monitoring sample to be taken.

OSHA assumes that employers use an organic vapor badge for monitoring because these badges do not interfere with workers' work activity. An in-house laboratory technician, on average, will spend 1 hour to administer and collect vapor badges.

1. Initial and periodic monitoring

The Vinyl Chloride standard requires workers exposed above the action level but below the PEL to be monitored semiannually.

      Burden hours:   45 workers x 2 times per year x 1 hour = 90 hours
               Cost:    90 hours x $37.08 = $3,337.20

The Vinyl Chloride standard requires workers exposed above the PEL to be monitored quarterly.

      Burden hours:  45 workers x 4 times per year x 1 hour = 180 hours
                Cost: 180 hours x $37.08 = $6,674.40

2. Additional monitoring

      Burden hours:  28 employers x 1 time per year x 1 hour = 28 hours
               Cost:   28 hours x $37.08 = $1,038.24

(B) Written Compliance Plan (§§ 1910.1017(f)(2) and (f)(3))

	Employers who cannot use engineering and work practice controls immediately to reduce worker VC exposures to a level at or below the PEL, must develop and implement a plan for doing so. If this level cannot be attained using only engineering and work-practice controls, then the written plan must explain how these controls will be used to reduce worker VC exposures to the lowest level feasible. The plan must be written and updated annually. OSHA estimates that 7 facilities must update their written plans annually, and that it takes eight hours of a manger's time, and four hours of clerical time, to update an existing plan. The previous ICR estimated that 25% of the total facilities must update their written plans annually. OSHA assumes that this ratio has remained constant.

      Burden hours:  7 facilities x 1 annually x 12 hours = 84 hours
                     Cost:   7 facilities x 8 manager hours x $45.70 =  $2,559.20
                                                   7 facilities x 4 secretary hours x $27.46 =     $768.88
			   Total Cost:						$3,328.08
                     
(C) Respiratory Program (§ 1910.1017(g)(2))

The standard requires that a respiratory protection program meeting the requirements of 29 CFR 1910.134 be established and maintained.  The burden associated with this provision is determined under the Respiratory Protection ICR (OMB Control Number 1218-0099).

(D) Emergency Plan (§ 1910.1017(i))

Employers must develop a written plan addressing emergency situations for facilities that store, handle, and use VC as a liquid or a compressed gas. The development of this plan applies only to new facilities. The Agency is unaware of any new VC or PVC facilities; therefore, no burden hours have been attributed for this activity.

(E) Medical Surveillance (§ 1910.1017(k))

1. Medical exams

The VC standard requires that a medical surveillance program be instituted for workers exposed to VC in excess of the action level. Burden hours are attributed to the time workers are away from work. OSHA assumes that a manufacturing worker would be away from work for a total of two hours for each surveillance event. The number of workers was determined from the number of worker monitoring records.

      Burden hours:  90 workers x 1 annually x 2 hours = 180 hours
               Cost:  180 hours x $43.95 = $7,911.00

2. Physician's written opinion (§ 1910.1017(k)(4))

Employers are required to obtain, and provide to each worker, a copy of a physician's statement regarding the worker's suitability for continued exposure to VC, including use of protective equipment and respirators if appropriate.

The Agency estimates a secretary will take five minutes (5/60 hour) to give a copy of the physician's written opinion to an affected worker. The number of exams was determined from the figures in "Medical exams" above.

      Burden hours:  90 examinations x 5/60 hour = 7.50 hours 
               Cost:   7.50 hours x $27.46 = $205.95
            
(F) Communication of Hazards (§ 1910.1017(l))

Warning signs and labels

The standard requires that warning signs be provided and displayed outside, and at approaches to, regulated areas, areas containing hazardous operations, and where an emergency exists. Since OSHA is providing specific language in the regulation for these situations, no burden hours are attributed to this provision.

Containers of VC, PVC, and PVC resin waste generated from reactors and other waste contaminated with VC must be labeled. Specific language is provided by OSHA for these labels, so no burden hours are attributed to this provision. 

(G) Recordkeeping (§ 1910.1017(m))

1. Exposure monitoring records and retention

Exposure monitoring records are required to include the date of monitoring, concentrations determined, identity of the instrument and methods used, and any additional information necessary to determine individual exposures if such exposures are determined by means other than individual monitoring. OSHA estimates that a secretary will take approximately five minutes (5/60 hour) to maintain these records.

      Exposure above the action level, but below the PEL

      Burden hours:  45 workers x 2 times per year x 5/60 hour = 7.50 hours
                Cost:  7.5 hours x $27.46 = $205.95

      Exposure above the PEL

      Burden hours:  45 workers x 4 times per year x 5/60 hour = 15 hours
               Cost:   15 hours x $27.46 = $411.90

Additional monitoring

      Burden hours:  28 employers x 1 annually x 5/60 hour = 2.33 hours
                Cost:  2.33 hours x $27.46 = $63.98

2. Medical records

OSHA estimates that maintaining medical records requires approximately five minutes (5/60 hour) of clerical time annually per record. The following equations are based on the assumptions described under "Medical exams" above.

      Burden hours:  90 workers x 1 annually x 5/60 hour = 7.50 hours
               Cost:   7.50 hours x $27.46 = $205.95

3. Records access

The VC standard requires that employers make available exposure monitoring and measuring, and medical records upon request to employees and their designated employees.

OSHA does not expect that employers would receive very many requests from employees since the employer already notifies the employee of their exposure monitoring results and provides medical statements. The Agency estimates that one employer will receive an employee request to access their exposure and medical records. OSHA believes that a manager, at $45.70 per hour, will expend approximately five minutes 5/60 hour) to make records available to the employee. 

      Burden hours:  1 employer x 5/60 hour = 0.08 hour
      Cost:      0.08 hour x $45.70 = $3.66

        Table 2 - Estimated Annualized Respondent Hour and Cost Burden 
                                   Activity
                              No. of Respondents
                        No. of Responses per Respondent
                                Total Responses
                            Average Burden (Hours)
                             Total Burden (Hours)
                               Hourly Wage Rate
                               Total Burden Cost
(A) Exposure Monitoring (§ 1910.1017(d)(2) and (d)(3))
Initial and Periodic Monitoring
                                      45
                                       2
                                      90
                                       1
                                      90
                                    $37.08
                                   $3,337.20

                                      45
                                       4
                                      180
                                       1
                                      180
                                    $37.08
                                   $6,674.40
Additional Monitoring
                                      28
                                       1
                                      28
                                       1
                                      28
                                    $37.08
                                   $1,038.24
Subtotal 
                                      --
                                      --
                                      298
                                      --
                                      298
                                      --
                                  $11,049.84
(B) Written Compliance Plan (§ 1910.1017(f)(2) and (f)(3))

                                       7
                                       1
                                       7
                                       8
                                      56
                                    $45.70
                                   $2,559.20

                                       7
                                       1
                                       7
                                       4
                                      28
                                    $27.46
                                    $768.88
Subtotal
                                      --
                                      --
                                      14
                                      --
                                      84
                                       -
                                   $3,328.08
(C) Respiratory Program (§ 1910.1017(g)(2))
(D) Emergency Plan (§ 1910.1017(i))
(E) Medical Surveillance (§ 1910.1017(k))
Medical Exams
                                      90
                                       1
                                      90
                                       2
                                      180
                                     $43.95
                                   $7,911.00
Physician's Written Opinion (§ 1910.1017(k)(4))
                                      90
                                       1
                                      90
                                     5/60
                                      7.5
                                    $27.46
                                    $205.95
Subtotal
                                      --
                                      --
                                      180
                                      --
                                     187.5
                                      --
                                   $8,116.95
(F) Communication of Hazards (§ 1910.1017(l))
(G) Recordkeeping (§ 1910.1017(m))
Exposure Monitoring and Retention 
                                      45
                                       2
                                      90
                                     5/60
                                     7.50
                                    $27.46
                                    $205.95

                                      45
                                       4
                                      180
                                     5/60
                                      15
                                    $27.46
                                    $411.90

                                      28
                                       1
                                      28
                                     5/60
                                     2.33
                                    $27.46
                                    $63.98
Medical Records
                                      90
                                       1
                                      90
                                     5/60
                                     7.50
                                    $27.46
                                    $205.95
Records Access
                                       1
                                       1
                                       1
                                     5/60
                                     0.08
                                    $45.70
                                     $3.66
Subtotal
                                      --
                                      --
                                      389
                                      --
                                     32.41
                                      --
                                    $891.44
GRAND TOTALS
                                      --
                                      --
                                      881
                                      --
                                      602
                                      --
                                  $23,386.31
      

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 service 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 of 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 collection services should be a 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.

Exposure Monitoring

Employers are required to conduct initial exposure monitoring to determine if there are any workers exposed in excess of the action level. Results from the initial exposure monitoring will determine if further monitoring is required. If exposure levels are above the PEL, then the employer is required to conduct at least quarterly monitoring. If the exposure readings are above the action level, but at or below the PEL, then semi-annual monitoring must be conducted. (The use of respirators cannot be considered in making these exposure determinations.)

In addition to production, process, or control changes that may result in new or additional VC exposures and an increased exposure-monitoring requirement, monitoring must also be conducted if the employer has any other reason to suspect that workers may be exposed in excess of the action level. The Agency assumes that employers will use an organic vapor badge to conduct required monitoring. The cost for the badge and the lab analysis for the badge is estimated to be $50.

      Exposure above the action level, but below the PEL

            Cost:	45 workers x 2 times per year x $50 = $4,500

      Exposure above the PEL

            Cost:	45 workers x 4 times per year x $50 = $9,000

      Additional monitoring

            Cost:	28 employers x 1 time per year x $50 = $1,400

                                                              Total cost for exposure monitoring: $14,900
Medical Exams

The Agency assumes that each medical exam, which includes the physician's written opinion, costs the employer $195.  Approximately 90 medical exams will be given each year at a total cost of $17,550.
            Cost:	90 examinations x $195 = $17,550
            
The total costs is $14,900 exposure monitoring + $17,550 medical examinations = $32,450

14.  Provide estimates of the 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), any other expense that would not have been incurred without this collection of information.  Agencies also may aggregate cost estimates from Items 12, 13, and 14 into a single table.

There is no cost to the Federal government associated with this information collection request.  The Agency has no annualized cost associated with enforcing the Standard.  OSHA would only review records in the context of an investigation of a particular employer to determine compliance with the Standard.  These activities are outside the scope of the PRA.  See 5 CFR 1320.4(a)(2).

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

The agency is requesting an adjustment decrease in the number of burden hours from 604 to 602, a total reduction of 2 burden hours.  The decrease is a result of the agencies new method of rounding burden hours. There is also a decrease in capital costs from $51,358 to $32,450, a total decrease of $18,908. The decrease is primarily due to updated costs for exposure monitoring samples and medical examinations.

16. For collections of information whose results will be published, outline plans for tabulations, 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.

OSHA lists current valid control numbers in §§ 1910.8, 1915.8, 1917.4, 1918.4, and 1926.5 and publishes the expiration date in the Federal Register notice announcing OMB approval of the information collection requirement (See 5 CFR 1320.3(f)(3)).  OSHA believes that this is the most appropriate and accurate mechanism to inform interested parties of these expiration dates.

18.  Explain each exception to the certification statement.
   
OSHA is not requesting an exception to the certification statement.

 COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS.

This supporting statement does not contain any collection of information requirements that employ statistical methods.

                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                  Table 3: Requested Burden Hour Adjustments

                                       
                      Information Collection Requirements
                                       
                             Current Burden Hours
                                       
                            Requested Burden Hours
                                  Adjustments
                              Cost Under Item 12

(A) Exposure Monitoring

                                       

     1.  Initial and Periodic Monitoring
                                                                           270 
                                                                            270
                                                                              0
                                                                    $10,011.60 

     2.  Additional Monitoring
                                                                             28
                                                                             28
                                                                              0
                                                                      $1,038.24

(B) Written Compliance Program
                                                                             84
                                                                             84
                                                                              0
                                                                      $3,328.08

(E) Medical Surveillance   
                                                                               
                                                                               
                                                                              
                                                                              

     (1) Medical Exams
                                                                            180
                                                                            180
                                                                              0
                                                                     $7,911.00 

     (2) Physician's Opinion
                                                                              8
                                                                            7.5
                                                                           -0.5
                                                                        $205.95

(G) Recordkeeping
                                                                               
                                                                               
                                                                              
                                                                              

    1. Exposure Monitoring
                                                                             25
                                                                          24.83
                                                                          -0.17
                                                                       $681.83 

    2. Medical Records                
                                                                              8
                                                                           7.50
                                                                          -0.50
                                                                        $205.95
    3. Access to Records
                                                                              1
                                                                           0.08
                                                                          -0.92
                                                                          $3.66
                                       
                                    Totals
                                                                            604
                                                                            602
                                                                          -2.09
                                                                    $23,386.31 

                      SEC. 2. Congressional Findings and Purpose

 The Congress finds that personal injuries and illnesses arising out of work situations impose a substantial burden upon, and are a hindrance to, interstate commerce in terms of lost production, wage loss, medical expenses, and disability compensation payments.

 The Congress declares it to be its purpose and policy, through the exercise of its powers to regulate commerce among the several States and with foreign nations and to provide for the general welfare, 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 USC 651

   (1) by encouraging employers and employees in their efforts to reduce the number of occupational safety and health hazards at their places of employment, and to stimulate employers and employees to institute new and to perfect existing programs for providing safe and healthful working conditions; 
   (2) by providing that employers and employees have separate but dependent responsibilities and rights with respect to achieving safe and healthful working conditions;

 by authorizing the Secretary of Labor to set mandatory occupational safety and health standards applicable to businesses affecting interstate commerce, and by creating an Occupational Safety and Health Review Commission for carrying out adjudicatory functions under the Act;

 by building upon advances already made through employer and employee initiative for providing safe and healthful working conditions;

 by providing for research in the field of occupational safety and health, including the psychological factors involved, and by developing innovative methods, techniques, and approaches for dealing with occupational safety and health problems;

 by exploring ways to discover latent diseases, establishing causal connections between diseases and work in environmental conditions, and conducting other research relating to health problems, in recognition of the fact that occupational health standards present problems often different from those involved in occupational safety;

 by providing medical criteria which will assure insofar as practicable that no employee will suffer diminished health, functional capacity, or life expectancy as a result of his work experience;
   
 by providing for training programs to increase the number and competence of personnel engaged in the field of occupational safety and health; affecting the OSH Act since its passage in 1970 through January 1, 2004.

 by providing for the development and promulgation of occupational safety and health standards;

 by providing an effective enforcement program which shall include a prohibition against giving advance notice of any inspection and sanctions for any individual violating this prohibition;

 by encouraging the States to assume the fullest responsibility for the administration and enforcement of their occupational safety and health laws by providing grants to the States to assist in identifying their needs and responsibilities in the area of occupational safety and health, to develop plans in accordance with the provisions of this Act, to improve the administration and enforcement of State occupational safety and health laws, and to conduct experimental and demonstration projects in connection therewith;

  by providing for appropriate reporting procedures with respect to occupational safety and health which procedures will help achieve the objectives of this Act and accurately describe the nature of the occupational safety and health problem;

              6. Occupational Safety and Health Standards

  29 USC 655:
 Without regard to chapter 5 of title 5, United States Code, or to the other subsections of this section, the Secretary shall, as soon as practicable during the period beginning with the effective date of this Act and ending two years after such date, by rule promulgate as an occupational safety or health standard any national consensus standard, and any established Federal standard, unless he determines that the promulgation of such a standard would not result in improved safety or health for specifically designated employees. In the event of conflict among any such standards, the Secretary shall promulgate the standard which assures the greatest protection of the safety or health of the affected employees.

 The Secretary may by rule promulgate, modify, or revoke any occupational safety or health standard in the following manner:
 Whenever the Secretary, upon the basis of information submitted to him in writing by an interested person, a representative of any organization of employers or employees, a nationally recognized standards-producing organization, the Secretary of Health and Human Services, the National Institute for Occupational Safety and Health, or a State or political subdivision, or on the basis of information developed by the Secretary or otherwise available to him, determines that a rule should be promulgated in order to serve the objectives of this Act, the Secretary may request the recommendations of an advisory committee appointed under section 7 of this Act. The Secretary shall provide such an advisory committee with any proposals of his own or of the Secretary of Health and Human Services, together with all pertinent factual information developed by the Secretary or the Secretary of Health and Human Services, or otherwise available, including the results of research, demonstrations, and experiments. An advisory committee shall submit to the Secretary its recommendations regarding the rule to be promulgated within ninety days from the date of its appointment or within such longer or shorter period as may be prescribed by the Secretary, but in no event for a period which is longer than two hundred and seventy days.

 The Secretary shall publish a proposed rule promulgating, modifying, or revoking an occupational safety or health standard in the Federal Register and shall afford interested persons a period of thirty days after publication to submit written data or comments. Where an advisory committee is appointed and the Secretary determines that a rule should be issued, he shall publish the proposed rule within sixty days after the submission of the advisory committee's recommendations or the expiration of the period prescribed by the Secretary for such submission.

 On or before the last day of the period provided for the submission of written data or comments under paragraph (2), any interested person may file with the Secretary written objections to the proposed rule, stating the grounds therefore and requesting a public hearing on such objections. Within thirty days after the last day for filing such objections, the Secretary shall publish in the Federal Register a notice specifying the occupational safety or
   health standard to which objections have been filed and a hearing requested, and specifying a time and place for such hearing.
 Within sixty days after the expiration of the period provided for the submission of written data or comments under paragraph (2), or within sixty days after the completion of any hearing held under paragraph (3), the Secretary shall issue a rule promulgating, modifying, or revoking an occupational safety or health standard or make a determination that a rule should not be issued. Such a rule may contain a provision delaying its effective date for such period (not in excess of ninety days) as the Secretary determines may be necessary to insure that affected employers and employees will be informed of the existence of the standard and of its terms and that employers affected are given an opportunity to familiarize themselves and their employees with the existence of the requirements of the standard.

 The Secretary, in promulgating standards dealing with toxic materials or harmful physical agents under this subsection, shall set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life. Development of standards under this subsection shall be based upon research, demonstrations, experiments, and such other information as may be appropriate. In addition to the attainment of the highest degree of health and safety protection for the employee, other considerations shall be the latest available scientific data in the field, the feasibility of the standards, and experience gained under this and other health and safety laws. Whenever practicable, the standard promulgated shall be expressed in terms of objective criteria and of the performance desired.

 (A) Any employer may apply to the Secretary for a temporary order granting a variance from a standard or any provision thereof promulgated under this section. Such temporary order shall be granted only if the employer files an application which meets the requirements of clause (B) and establishes

    that --
 he is unable to comply with a standard by its effective date because of unavailability of professional or technical personnel or of materials and equipment needed to come into compliance with the standard or because necessary construction or alteration of facilities cannot be completed by the effective date,

 he is taking all available steps to safeguard his employees against the hazards covered by the standard, and

 he has an effective program for coming into compliance with the standard as quickly as practicable.
  Any temporary order issued under this paragraph shall prescribe the practices, means, methods, operations, and processes which the employer must adopt and use while the order is in effect and state in detail his program for coming into compliance with the standard. Such a temporary order may be granted only after notice to employees and an opportunity for a hearing: Provided, That the Secretary may issue one interim order to be effective until
  a decision is made on the basis of the hearing. No temporary order may be in effect for longer than the period needed by the employer to achieve
    compliance with the standard or one year, whichever is shorter, except that such an order may be renewed not more that twice (I) so long as the requirements of this paragraph are met and (II) if an application for renewal is filed at least 90 days prior to the expiration date of the order. No interim renewal of an order may remain in effect for longer than 180 days.
 An application for temporary order under this paragraph (6) shall contain:

 a specification of the standard or portion thereof from which the employer seeks a variance,

 a representation by the employer, supported by representations from qualified persons having firsthand knowledge of the facts represented, that he is unable to comply with the standard or portion thereof and a detailed statement of the reasons therefor,

 a statement of the steps he has taken and will take (with specific dates) to protect employees against the hazard covered by the standard,

 a statement of when he expects to be able to comply with the standard and what steps he has taken and what steps he will take (with dates specified) to come into compliance with the standard, and

 a certification that he has informed his employees of the application by giving a copy thereof to their authorized representative, posting a statement giving a summary of the application and specifying where a copy may be examined at the place or places where notices to employees are normally posted, and by other appropriate means.

   A description of how employees have been informed shall be contained in the certification. The information to employees shall also inform them of their right to petition the Secretary for a hearing.

   (C) The Secretary is authorized to grant a variance from any standard or portion thereof whenever he determines, or the Secretary of Health and Human Services certifies, that such variance is necessary to permit an employer to participate in an experiment approved by him or the Secretary of Health and Human Services designed to demonstrate or validate new and improved techniques to safeguard the health or safety of workers.
  (7) Any standard promulgated under this subsection shall prescribe the use of labels or other appropriate forms of warning as are necessary to insure that employees are apprised of all hazards to which they are exposed, relevant symptoms and appropriate emergency treatment, and proper conditions and precautions of safe use or exposure. Where appropriate, such standard shall also prescribe suitable protective equipment and control or technological procedures to be used in connection with such hazards and shall provide for monitoring or measuring employee exposure at such locations and intervals, and in such manner as may be necessary for the protection of employees. In addition, where appropriate, any such standard shall prescribe the type and frequency of medical examinations or other tests which shall be made available, by the employer or at his cost, to employees exposed to such hazards in order to most effectively determine whether the health of such
  employees is adversely affected by such exposure. In the event such medical examinations are in the nature of research, as determined by the Secretary of Health and Human Services, such examinations may be furnished at the expense of the Secretary of Health and Human Services. The results of such examinations or tests shall be furnished only to the Secretary or the Secretary of Health and Human Services, and, at the request of the employee, to his physician. The Secretary, in consultation with the Secretary of Health and Human Services, may be rule promulgated pursuant to section 553 of title 5, United States Code, make appropriate modifications in the foregoing requirements relating to the use of labels or other forms of warning, monitoring or measuring, and medical examinations, as may be warranted by experience, information, or medical or technological developments acquired subsequent to the promulgation of the relevant standard.
  
  (8) Whenever a rule promulgated by the Secretary differs substantially from an existing national consensus standard, the Secretary shall, at the same time, publish in the Federal Register a statement of the reasons why the rule as adopted will better effectuate the purposes of this Act than the national consensus standard.
  
  (c)(1) The Secretary shall provide, without regard to the requirements of chapter 5, title 5, Unites States Code, for an emergency temporary standard to take immediate effect upon publication in the Federal Register if he determines  - 
  
 that employees are exposed to grave danger from exposure to substances or agents determined to be toxic or physically harmful or from new hazards, and
  
 that such emergency standard is necessary to protect employees from such danger.
  
  (2) Such standard shall be effective until superseded by a standard promulgated in accordance with the procedures prescribed in paragraph (3) of this subsection. 
  
  (3) Upon publication of such standard in the Federal Register the Secretary shall commence a proceeding in accordance with section 6 (b) of this Act, and the standard as published shall also serve as a proposed rule for the proceeding. The Secretary shall promulgate a standard under this paragraph no later than six months after publication of the emergency standard as provided in paragraph (2) of this subsection.
  (d) Any affected employer may apply to the Secretary for a rule or order for a variance from a standard promulgated under this section. Affected employees shall be given notice of each such application and an opportunity to participate in a hearing. The Secretary shall issue such rule or order if he determines on the record, after opportunity for an inspection where appropriate and a hearing, that the proponent of the variance has demonstrated by a preponderance of the evidence that the conditions, practices, means, methods, operations, and processes which he must adopt and utilize to the extent they differ from the standard in question. Such a rule or order may be modified or revoked upon application by an employer, employees, or by the Secretary on his own motion, in the manner prescribed for its issuance under this subsection at any time after six months from its issuance.
  
  (e) Whenever the Secretary promulgates any standard, makes any rule, order, or decision, grants any exemption or extension of time, or compromises, mitigates, or settles any penalty assessed under this Act, he shall include a statement of the reasons for such action, which shall be published in the Federal Register.  
  
  (f) Any person who may be adversely affected by a standard issued under this section may at any time prior to the sixtieth day after such standard is promulgated file a petition challenging the validity of such standard with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for a judicial review of such standard. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary. The filing of such petition shall not, unless otherwise ordered by the court, operate as a stay of the standard. The determinations of the Secretary shall be conclusive if supported by substantial evidence in the record considered as a whole.
  
  (g) In determining the priority for establishing standards under this section, the Secretary shall give due regard to the urgency of the need for mandatory safety and health standards for particular industries, trades, crafts, occupations, businesses, workplaces or work environments. The Secretary shall also give due regard to the recommendations of the Secretary of Health and Human Services regarding the need for mandatory standards in determining the priority for establishing such standards. 

                    SEC. 8. Inspections, Investigations, and Recordkeeping
                                                                     29 USC 657
                                                                               
 In order to carry out the purposes of this Act, the Secretary, upon presenting appropriate credentials to the owner, operator, or agent in charge, is authorized  - 
 
 to enter without delay and at reasonable times any factory, plant, establishment, construction site, or other area, workplace or environment where work is performed by an employee of an employer; and

 to inspect and investigate during regular working hours and at other reasonable times, and within reasonable limits and in a reasonable manner, any such place of employment and all pertinent conditions, structures, machines, apparatus, devices, equipment, and materials therein, and to question privately any such employer, owner, operator, agent or employee.

  In making his inspections and investigations under this Act the Secretary may require the attendance and testimony of witnesses and the production of evidence under oath. Witnesses shall be paid the same fees and mileage that are paid witnesses in the courts of the United States. In case of a contumacy, failure, or refusal of any person to obey such an order, any district court of the United States or the United States courts of any territory or possession, within the jurisdiction of which such person is found, or resides or transacts business, upon the application by the Secretary, shall have jurisdiction to issue to such person an order requiring such person to appear to produce evidence if, as, and when so ordered, and to give testimony relating to the matter under investigation or in question, and any failure to obey such order of the court may be punished by said court as a contempt thereof.

 (1) Each employer shall make, keep and preserve, and make available to the Secretary or the Secretary of Health and Human Services, such records regarding his activities relating to this Act as the Secretary, in cooperation with the Secretary of Health and Human Services, 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. In order to carry out the provisions of this paragraph such regulations may include provisions requiring employers to conduct periodic inspections. The Secretary shall also issue regulations requiring that employers, through posting of notices or other appropriate means, keep their employees informed of their protections and obligations under this Act, including the provisions of applicable standards.

 The Secretary, in cooperation with the Secretary of Health and Human Services, shall prescribe regulations requiring employers to maintain accurate records of, and to make periodic reports on, work-related deaths, injuries and illnesses other than minor injuries requiring only first aid treatment and which do not involve medical treatment, loss of consciousness, restriction of work or motion, or transfer to another job.
    
 The Secretary, in cooperation with the Secretary of Health and Human Services, shall issue regulations requiring employers to maintain accurate records of employee exposures to potentially toxic materials or harmful physical agents which are required to be monitored or measured under section 6. Such regulations shall provide employees or their representatives with an opportunity to observe such monitoring or measuring, and to have access to the records thereof. Such regulations shall also make appropriate provision for each employee or former employee to have access to such records as will indicate his own exposure to toxic materials or harmful physical agents. Each employer shall promptly notify any employee who has been or is being exposed to toxic materials or harmful physical agents in concentrations or at levels which exceed those prescribed by an applicable occupational safety and health standard promulgated under section 6, and shall inform any employee who is being thus exposed of the corrective action being taken.

 Any information obtained by the Secretary, the Secretary of Health and Human Services, or a State agency under this Act shall be obtained with a minimum burden upon employers, especially those operating small businesses. Unnecessary duplication of efforts in obtaining information shall be reduced to the maximum extent feasible.
 
 Subject to regulations issued by the Secretary, a representative of the employer and a representative authorized by his employees shall be given an opportunity to accompany the Secretary or his authorized representative during the physical inspection of any workplace under subsection (a) for the purpose of aiding such inspection. Where there is no authorized employee representative, the Secretary or his authorized representative shall consult with a reasonable number of employees concerning matters of health and safety in the workplace.

 (1) Any employees or representative of employees who believe that a violation of a safety or health standard exists that threatens physical harm, or that an imminent danger exists, may request an inspection by giving notice to the Secretary or his authorized representative of such violation or danger. Any such notice shall be reduced to writing, shall set forth with reasonable particularity the grounds for the notice, and shall be signed by the employees or representative of employees, and a copy shall be provided the employer or his agent no later than at the time of inspection, except that, upon the request of the person giving such notice, his name and the names of individual employees referred to therein shall not appear in such copy or on any record published, released, or made available pursuant to subsection (g) of this section. If upon receipt of such notification the Secretary determines there are reasonable grounds to believe that such violation or danger exists, he shall make a special inspection in accordance with the provisions of this section as soon as practicable, to determine if such violation or danger exists. If the Secretary determines there are no reasonable grounds to believe that a violation or danger exists he shall notify the employees or representative of the employees in writing of such determination.
 
    (2) Prior to or during any inspection of a workplace, any employees or representative of employees employed in such workplace may notify the Secretary or any representative of the Secretary responsible for conducting the inspection, in writing, of any violation of this Act which they have reason to believe exists in such workplace. The Secretary shall, by regulation, establish procedures for informal review of any refusal by a representative of the Secretary to issue a citation with respect to any such alleged violation and shall furnish the employees or representative of employees requesting such review a written statement of the reasons for the Secretary's final disposition of the case. 
    
 (1) The Secretary and Secretary of Health and Human Services are authorized to compile, analyze, and publish, either in summary or detailed form, all reports or information obtained under this section.

    (2) The Secretary and the Secretary of Health and Human Services shall each prescribe such rules and regulations as he may deem necessary to carry out their responsibilities under this Act, including rules and regulations dealing with the inspection of an employer's establishment.
 The Secretary shall not use the results of enforcement activities, such as the number of citations issued or penalties assessed, to evaluate employees directly involved in enforcement activities under this Act or to impose quotas or goals with regard to the results of such activities.
                                                                               
                                                          Pub. L. 105-198 added
subsection (h).Electronic Code of Federal Regulations
                                       
e-CFR data is current as of April 5, 2021

Title 29 --> Subtitle B --> Chapter XVII --> Part 1910 --> Subpart Z --> §1910.1017
                                       
Title 29: Labor 
PART 1910 -- OCCUPATIONAL SAFETY AND HEALTH STANDARDS (CONTINUED) 
Subpart Z -- Toxic and Hazardous Substances 

§1910.1017   Vinyl chloride.
    (a) Scope and application. (1) This section includes requirements for the control of employee exposure to vinyl chloride (chloroethene), Chemical Abstracts Service Registry No. 75014.
    (2) This section applies to the manufacture, reaction, packaging, repackaging, storage, handling or use of vinyl chloride or polyvinyl chloride, but does not apply to the handling or use of fabricated products made of polyvinyl chloride.
    (3) This section applies to the transportation of vinyl chloride or polyvinyl chloride except to the extent that the Department of Transportation may regulate the hazards covered by this section.
    (b) Definitions -- (1) Action level means a concentration of vinyl chloride of 0.5 ppm averaged over an 8-hour work day.
    (2) Assistant Secretary means the Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, or his designee.
    (3) Authorized person means any person specifically authorized by the employer whose duties require him to enter a regulated area or any person entering such an area as a designated representative of employees for the purpose of exercising an opportunity to observe monitoring and measuring procedures.
    (4) Director means the Director, National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, or his designee.
    (5) Emergency means any occurrence such as, but not limited to, equipment failure, or operation of a relief device which is likely to, or does, result in massive release of vinyl chloride.
    (6) Fabricated product means a product made wholly or partly from polyvinyl chloride, and which does not require further processing at temperatures, and for times, sufficient to cause mass melting of the polyvinyl chloride resulting in the release of vinyl chloride.
    (7) Hazardous operation means any operation, procedure, or activity where a release of either vinyl chloride liquid or gas might be expected as a consequence of the operation or because of an accident in the operation, which would result in an employee exposure in excess of the permissible exposure limit.
    (8) OSHA Area Director means the Director for the Occupational Safety and Health Administration Area Office having jurisdiction over the geographic area in which the employer's establishment is located.
    (9) Polyvinyl chloride means polyvinyl chloride homopolymer or copolymer before such is converted to a fabricated product.
    (10) Vinyl chloride means vinyl chloride monomer.
    (c) Permissible exposure limit. (1) No employee may be exposed to vinyl chloride at concentrations greater than 1 ppm averaged over any 8-hour period, and
    (2) No employee may be exposed to vinyl chloride at concentrations greater than 5 ppm averaged over any period not exceeding 15 minutes.
    (3) No employee may be exposed to vinyl chloride by direct contact with liquid vinyl chloride.
    (d) Monitoring. (1) A program of initial monitoring and measurement shall be undertaken in each establishment to determine if there is any employee exposed, without regard to the use of respirators, in excess of the action level.
    (2) Where a determination conducted under paragraph (d)(1) of this section shows any employee exposures, without regard to the use of respirators, in excess of the action level, a program for determining exposures for each such employee shall be established. Such a program:
    (i) Must be repeated at least quarterly for any employee exposed, without regard to the use of respirators, in excess of the permissible exposure limit.
    (ii) Must be repeated not less than every 6 months for any employee exposed without regard to the use of respirators, at or above the action level.
    (iii) May be discontinued for any employee only when at least two consecutive monitoring determinations, made not less than 5 working days apart, show exposures for that employee at or below the action level.
    (3) Whenever there has been a production, process or control change which may result in an increase in the release of vinyl chloride, or the employer has any other reason to suspect that any employee may be exposed in excess of the action level, a determination of employee exposure under paragraph (d)(1) of this section shall be performed.
    (4) The method of monitoring and measurement shall have an accuracy (with a confidence level of 95 percent) of not less than plus or minus 50 percent from 0.25 through 0.5 ppm, plus or minus 35 percent from over 0.5 ppm through 1.0 ppm, and plus or minus 25 percent over 1.0 ppm. (Methods meeting these accuracy requirements are available in the "NIOSH Manual of Analytical Methods").
    (5) Employees or their designated representatives shall be afforded reasonable opportunity to observe the monitoring and measuring required by this paragraph.
    (e) Regulated area. (1) A regulated area shall be established where:
    (i) Vinyl chloride or polyvinyl chloride is manufactured, reacted, repackaged, stored, handled or used; and
    (ii) Vinyl chloride concentrations are in excess of the permissible exposure limit.
    (2) Access to regulated areas shall be limited to authorized persons.
    (f) Methods of compliance. Employee exposures to vinyl chloride shall be controlled to at or below the permissible exposure limit provided in paragraph (c) of this section by engineering, work practice, and personal protective controls as follows:
    (1) Feasible engineering and work practice controls shall immediately be used to reduce exposures to at or below the permissible exposure limit.
    (2) Wherever feasible engineering and work practice controls which can be instituted immediately are not sufficient to reduce exposures to at or below the permissible exposure limit, they shall nonetheless be used to reduce exposures to the lowest practicable level, and shall be supplemented by respiratory protection in accordance with paragraph (g) of this section. A program shall be established and implemented to reduce exposures to at or below the permissible exposure limit, or to the greatest extent feasible, solely by means of engineering and work practice controls, as soon as feasible.
    (3) Written plans for such a program shall be developed and furnished upon request for examination and copying to authorized representatives of the Assistant Secretary and the Director. Such plans must be updated at least annually.
    (g) Respiratory protection -- (1) General. For employees who use respirators required by this section, the employer must provide each employee an appropriate respirator that complies with the requirements of this paragraph.
    (2) Respirator program. The employer must implement a respiratory protection program in accordance §1910.134 (b) through (d) (except (d)(1)(iii), and (d)(3)(iii)(B)(1) and (2)), and (f) through (m) which covers each employee required by this section to use a respirator.
    (3) Respirator selection. (i) Employers must:
    (A) Select, and provide to employees, the appropriate respirators specified in paragraph (d)(3)(i)(A) of 29 CFR 1910.134.
    (B) Provide an organic vapor cartridge that has a service life of at least one hour when using a chemical cartridge respirator at vinyl chloride concentrations up to 10 ppm.
    (C) Select a canister that has a service life of at least four hours when using a powered air-purifying respirator having a hood, helmet, or full or half facepiece, or a gas mask with a front-or back-mounted canister, at vinyl chloride concentrations up to 25 ppm. 
    (ii) When air-purifying respirators are used:
    (A) Air-purifying canisters or cartridges must be replaced prior to the expiration of their service life or the end of the shift in which they are first used, whichever occurs first.
    (B) A continuous-monitoring and alarm system must be provided when concentrations of vinyl chloride could reasonably exceed the allowable concentrations for the devices in use. Such a system must be used to alert employees when vinyl chloride concentrations exceed the allowable concentrations for the devices in use.
    (h) Hazardous operations. (1) Employees engaged in hazardous operations, including entry of vessels to clean polyvinyl chloride residue from vessel walls, shall be provided and required to wear and use;
    (i) Respiratory protection in accordance with paragraphs (c) and (g) of this section; and
    (ii) Protective garments to prevent skin contact with liquid vinyl chloride or with polyvinyl chloride residue from vessel walls. The protective garments shall be selected for the operation and its possible exposure conditions.
    (2) Protective garments shall be provided clean and dry for each use.
    (i) Emergency situations. A written operational plan for emergency situations shall be developed for each facility storing, handling, or otherwise using vinyl chloride as a liquid or compressed gas. Appropriate portions of the plan shall be implemented in the event of an emergency. The plan shall specifically provide that:
    (1) Employees engaged in hazardous operations or correcting situations of existing hazardous releases shall be equipped as required in paragraph (h) of this section;
    (2) Other employees not so equipped shall evacuate the area and not return until conditions are controlled by the methods required in paragraph (f) of this section and the emergency is abated.
    (j) Training. Each employee engaged in vinyl chloride or polyvinyl chloride operations shall be provided training in a program relating to the hazards of vinyl chloride and precautions for its safe use.
    (1) The program shall include:
    (i) The nature of the health hazard from chronic exposure to vinyl chloride including specifically the carcinogenic hazard;
    (ii) The specific nature of operations which could result in exposure to vinyl chloride in excess of the permissible limit and necessary protective steps;
    (iii) The purpose for, proper use, and limitations of respiratory protective devices;
    (iv) The fire hazard and acute toxicity of vinyl chloride, and the necessary protective steps;
    (v) The purpose for and a description of the monitoring program;
    (vi) The purpose for, and a description of, the medical surveillance program;
    (vii) Emergency procedures;
    (viii) Specific information to aid the employee in recognition of conditions which may result in the release of vinyl chloride; and
    (ix) A review of this standard at the employee's first training and indoctrination program, and annually thereafter.
    (2) All materials relating to the program shall be provided upon request to the Assistant Secretary and the Director.
    (k) Medical surveillance. A program of medical surveillance shall be instituted for each employee exposed, without regard to the use of respirators, to vinyl chloride in excess of the action level. The program shall provide each such employee with an opportunity for examinations and tests in accordance with this paragraph. All medical examinations and procedures shall be performed by or under the supervision of a licensed physician, and shall be provided without cost to the employee.
    (1) At the time of initial assignment, or upon institution of medical surveillance;
    (i) A general physical examination shall be performed, with specific attention to detecting enlargement of liver, spleen or kidneys, or dysfunction in these organs, and for abnormalities in skin, connective tissues and the pulmonary system (See appendix A).
    (ii) A medical history shall be taken, including the following topics:
    (A) Alcohol intake;
    (B) Past history of hepatitis;
    (C) Work history and past exposure to potential hepatotoxic agents, including drugs and chemicals;
    (D) Past history of blood transfusions; and
    (E) Past history of hospitalizations.
    (iii) A serum specimen shall be obtained and determinations made of:
    (A) Total bilirubin;
    (B) Alkaline phosphatase;
    (C) Serum glutamic oxalacetic transaminase (SGOT);
    (D) Serum glutamic pyruvic transaminase (SGPT); and
    (E) Gamma glustamyl transpeptidase.
    (2) Examinations must be provided in accordance with this paragraph at least annually.
    (3) Each employee exposed to an emergency shall be afforded appropriate medical surveillance.
    (4) A statement of each employee's suitability for continued exposure to vinyl chloride including use of protective equipment and respirators, shall be obtained from the examining physician promptly after any examination. A copy of the physician's statement shall be provided each employee.
    (5) If any employee's health would be materially impaired by continued exposure, such employee shall be withdrawn from possible contact with vinyl chloride.
    (6) Laboratory analyses for all biological specimens included in medical examination shall be performed by accredited laboratories.
    (7) If the examining physician determines that alternative medical examinations to those required by paragraph (k)(1) of this section will provide at least equal assurance of detecting medical conditions pertinent to the exposure to vinyl chloride, the employer may accept such alternative examinations as meeting the requirements of paragraph (k)(1) of this section, if the employer obtains a statement from the examining physician setting forth the alternative examinations and the rationale for substitution. This statement shall be available upon request for examination and copying to authorized representatives of the Assistant Secretary and the Director.
    (l) Communication of hazards -- (1) Hazard communication -- general. (i) Chemical manufacturers, importers, distributors and employers shall comply with all requirements of the Hazard Communication Standard (HCS) (§1910.1200) for vinyl chloride and polyvinyl chloride.
    (ii) In classifying the hazards of vinyl chloride at least the following hazards are to be addressed: Cancer; central nervous system effects; liver effects; blood effects; and flammability.
    (iii) Employers shall include vinyl chloride in the hazard communication program established to comply with the HCS (§1910.1200). Employers shall ensure that each employee has access to labels on containers of vinyl chloride and to safety data sheets, and is trained in accordance with the requirements of HCS and paragraph (j) of this section.
    (2) Signs. (i) The employer shall post entrances to regulated areas with legible signs bearing the legend:
  DANGER
  VINYL CHLORIDE
  MAY CAUSE CANCER
  AUTHORIZED PERSONNEL ONLY
    (ii) The employer shall post signs at areas containing hazardous operations or where emergencies currently exist. The signs shall be legible and bear the legend:
  DANGER
  VINYL CHLORIDE
  MAY CAUSE CANCER
  WEAR RESPIRATORY PROTECTION AND PROTECTIVE CLOTHING IN THIS AREA
  AUTHORIZED PERSONNEL ONLY
    (iii) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (l)(2)(i) of this section:
  CANCER-SUSPECT AGENT AREA
  AUTHORIZED PERSONNEL ONLY
    (iv) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (l)(2)(ii) of this section:
  CANCER-SUSPECT AGENT IN THIS AREA
  PROTECTIVE EQUIPMENT REQUIRED 
  AUTHORIZED PERSONNEL ONLY
    (3) Labels. (i) In addition to the other requirements in this paragraph (l), the employer shall ensure that labels for containers of polyvinyl chloride resin waste from reactors or other waste contaminated with vinyl chloride are legible and include the following information:
  CONTAMINATED WITH VINYL CHLORIDE
  MAY CAUSE CANCER
    (ii) Prior to June 1, 2015, employers may include the following information on labels of containers of polyvinyl chloride resin waste from reactors or other waste contaminated with vinyl chloride in lieu of the labeling requirements in paragraphs (l)(3)(i) of this section:
  CONTAMINATED WITH VINYL CHLORIDE
  CANCER-SUSPECT AGENT
    (4) Prior to June 1, 2015, employers may include the following information for containers of polyvinyl chloride in lieu of the labeling requirements in paragraphs (l)(1)(i) of this section:
  POLYVINYL CHLORIDE (OR TRADE NAME) 
  Contains
  VINYL CHLORIDE 
  VINYL CHLORIDE IS A CANCER-SUSPECT AGENT
    (5)(i) Prior to June 1, 2015, employers may include either the following information in either paragraph (l)(5)(i) or (l)(5)(ii) of this section on containers of vinyl chloride in lieu of the labeling requirements in paragraph (l)(1)(i) of this section:
  VINYL CHLORIDE
  EXTREMELY FLAMMABLE GAS UNDER PRESSURE
  CANCER-SUSPECT AGENT
    (ii) In accordance with 49 CFR Parts 170-189, with the additional legend applied near the label or placard:
  CANCER-SUSPECT AGENT
    (6) No statement shall appear on or near any required sign, label, or instruction which contradicts or detracts from the effect of any required warning, information, or instruction.
    (m) Records. (1) All records maintained in accordance with this section shall include the name of each employee where relevant.
    (2) Records of required monitoring and measuring and medical records shall be provided upon request to employees, designated representatives, and the Assistant Secretary in accordance with 29 CFR 1910.1020 (a) through (e) and (g) through (i). These records shall be provided upon request to the Director. Authorized personnel rosters shall also be provided upon request to the Assistant Secretary and the Director.
    (i) Monitoring and measuring records shall:
    (A) State the date of such monitoring and measuring and the concentrations determined and identify the instruments and methods used;
    (B) Include any additional information necessary to determine individual employee exposures where such exposures are determined by means other than individual monitoring of employees; and
    (C) Be maintained for not less than 30 years.
    (ii) [Reserved]
    (iii) Medical records shall be maintained for the duration of the employment of each employee plus 20 years, or 30 years, whichever is longer.
    (n) The employer must, within 15 working days after the receipt of the results of any monitoring performed under this section, notify each affected employee of these results and the steps being taken to reduce exposures within the permissible exposure limit either individually in writing or by posting the results in an appropriate location that is accessible to affected employees.
         Appendix A to §1910.1017 -- Supplementary Medical Information
    When required tests under paragraph (k)(1) of this section show abnormalities, the tests should be repeated as soon as practicable, preferably within 3 to 4 weeks. If tests remain abnormal, consideration should be given to withdrawal of the employee from contact with vinyl chloride, while a more comprehensive examination is made.
    Additional tests which may be useful:
    A. For kidney dysfunction: urine examination for albumin, red blood cells, and exfoliative abnormal cells.
    B. Pulmonary system: Forced vital capacity, Forced expiratory volume at 1 second, and chest roentgenogram (posterior-anterior, 14 x 17 inches).
    C. Additional serum tests: Lactic acid dehydrogenase, lactic acid dehydrogenase isoenzyme, protein determination, and protein electrophoresis.
    D. For a more comprehensive examination on repeated abnormal serum tests: Hepatitis B antigen, and liver scanning.
[39 FR 35896, Oct. 4, 1974. Redesignated at 40 FR 23072, May 28, 1975]
    Editorial Note: For Federal Register citations affecting §1910.1017, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.