Ss 1218-0010 06.6.18 Rocis

Vinyl Chloride Standard

1218-0010

June 2018

SUPPORTING STATEMENT FOR THE

INFORMATION COLLECTION REQUIREMENTS IN

THE VINYL CHLORIDE STANDARD (29 CFR 1910.1017)¹

OFFICE OF MANAGEMENT AND BUDGET

(OMB) CONTROL NO. 1218-0010 (June 2018) F

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).² 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 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 burdens.

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

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

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

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. 3506)(c)(2)(A)), OSHA published a notice in the Federal Register on February 22, 2018 (83 FR 7781) soliciting public comments on its proposal to extend the information collection requirements specified by the Standard on Vinyl Chloride (29 CFR 1910.1017). This notice was part of a preclearance consultation program that provided the general public and government agencies with an opportunity to comment. The Agency received one comment in response to this notice.

The comment was filed by Mr. Richard Krock, Vice President for Regulatory and Technical Affairs of the Vinyl Institute. In it, he raised questions about the pre-comment ICR Supporting Statement, with regard to the number of establishments affected, and the appropriate wage rate to apply to these establishments. He also raised a technical point regarding the language describing the estimated number of workers covered by the Exposure Monitoring provisions of the standard. The Agency has adopted most of these suggestions, as discussed in greater detail in Item 12 of this Supporting Statement.

 

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

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

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

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 collection 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. Generally, estimates should not include burden hours for customary and usual business practices.

• If this request for approval covers more than one form, provide separate hour burden estimates for each form.

• 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 14.

Respondent Burden-Hour and Cost burden Determinations

According to the Directory of Chemical Producers, 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.³ After reviewing the comments from the Vinyl Institute, which also primarily reference the Directory of Chemical Producers, the Agency is persuaded that there are more plants affected by the rule than initially estimated in the pre-comment paperwork burden analysis. For purposes of this ICR, the Agency accepts the analysis of the Vinyl Institute, 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.

In addition to the comment on the number of plants, the commenter, while accepting the ICRs estimates of employment in several types of plants, commented on employment in two types of plants. For the two plants producing non-vinyl products, the Vinyl Institute provided estimates of 20 employees per plant, which, in the absence of other more specific information, the Agency accepts. The commenter also argued that combined VC and PVC plants are more complex and typically have larger employment than other types of plants. While the Agency accepts this might well be the case, the commenter did not provide specific information on what the typical employment would be. Therefore, in the absence of more detail, for this ICR the Agency will accept that they are at least as large as the PVC plants, increasing the employment estimate for the combined plants from 163 to 178 employees. By this analysis of the affected plants, the number of workers in all facilities totals 4,528.⁴

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 2016 [date accessed: December 7, 2017]. (OES data is available at https://www.bls.gov/oes/tables.htm. To access a wage rate, select the year, “Occupation Profiles,” and the Standard Occupational Classification (SOC) code.) The Agency is adopting the suggestion of the Vinyl Institute to use the chemical industry-specific (NAICS 325100) wage rates, which are higher than the more general “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 account for fringe benefits, the Agency used the Bureau of Labor Statistics’ (BLS) Occupational Employment Statistics (OES) (2017). Fringe markup is from the following BLS release: Employer Costs for Employee Compensation news release text; released 10:00 AM (EDT), December 15, 2017 (https://www.bls.gov/news.release/pdf/ecec.pdf). BLS reported that for civilian workers, fringe benefits accounted for 31.7 percent of total compensation and wages accounted for the remaining 68.3 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 (A)	Fringe Benefits (B)	Loaded Hourly Wage Rate (C) = (A)/((1-(B))
Production Worker Occupations	51-8091	$30.84	.317	$45.15
First-Line Supervisors of Production and Operating Workers	51-1011	$35.87	.317	$52.52
Secretaries and Administrative Assistants	43-6014	$19.74	.317	$28.90
Chemical Technician	19-4031	$27.73	.317	$40.60

(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.⁵ 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 × 2 times per year × 1 hour = 90 hours

Cost: 90 hours × $40.60 = $3,654

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

Burden hours: 45 workers × 4 times per year × 1 hour = 180 hours

Cost: 180 hours × $40.60 = $7,308

2. Additional monitoring

Burden hours: 28 employers × 1 time per year × 1 hour = 28 hours

Cost: 28 hours × $40.60 = $1,137

(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 × 1 annually x 12 hours = 84 hours

Cost: 7 facilities × 8 manager hours × $52.52 = $2,941

7 facilities × 4 secretary hours × $28.90 = $809

Total Cost: $3,750

(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 × 1 annually × 2 hours = 180 hours

Cost: 180 hours × $45.15 = $8,127

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 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 × 5/60 hours = 8 hours

Cost: 8 hours × $28.90 = $231

(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 to maintain these records.

Exposure above the action level, but below the PEL

Burden hours: 45 workers × 2 times per year × 5/60 hours = 8 hours

Cost: 8 hours × $28.90 = $231

Exposure above the PEL

Burden hours: 45 workers × 4 times per year × 5/60 hours = 15 hours

Cost: 15 hours × $28.90 = $434

Additional monitoring

Burden hours: 28 employers × 1 annually × 5/60 hours = 2 hours

Cost: 2 hours × $28.90 = $58

2. Medical records

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

Burden hours: 90 workers × 1 annually × 5/60 hours = 8 hours

Cost: 8 hours × $28.90 = $231

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 $52.52 per hour, will expend approximately five minutes to make records available to the employee.

Burden hours: 1 employer × 5/60 hours = 1 hour

Cost: 1 hour × $52.52 = $53

Table 2 - Estimated Annualized Respondent Hour and Cost Burden
Information Collection Requirements	Type of Respondent	Number of Respondents	Number of Responses per Respondent	Total Number of Responses	Frequency	Avg. Burden per Response (In Hrs.)	Total Burden Hours	Avg. Wage Rate	Total Burden Costs
(A) Exposure Monitoring (§1910.1017(d)(2) and (d)(3))
Initial and Periodic Monitoring	Chemical Technician	28	1.607142	45	2	1	90	$40.60	$3,654
	Chemical Technician	28	1.607142	45	4	1	180	$40.60	$7,308
Additional Monitoring	Chemical Technician	28	1	28	1	1	28	$40.60	$1,137
Unduplicated Totals		--	--	118	--	--	298		$12,099
(B) Written Compliance Plan (§1910.1017(f)(2) and (f)(3))
	Supervisor	28	.25	7	1	8	56	$52.52	$2,941
	Secretary	28	.25	7	1	4	28	$28.90	$809
Duplicated Totals		--	-	7	--	-	84		$3,750
(C) Respiratory Program (§1910.1017(g)(2))
(D) Emergency Plan (§1910.1017(i))
(E) Medical Surveillance (§1910.1017(k))
Medical Exams	Production Worker	28	3.214286	90	1	2	180	$45.15	$8,127
Physician's written opinion (§1910.1017(k)(4))	Secretaries	28	3.214286	90	1	5/60	8	$28.90	$231
Unduplicated Totals		--	--	180	--	--	188	--	$8,358
(F) Communication of Hazards (§1910.1017(l))
(G) Recordkeeping (§1910.1017(m))
Exposure monitoring and retention	Secretaries	28	1.607142	45	2	5/60	8	$28.90	$231
	Secretaries	28	1.607142	45	4	5/60	15	$28.90	$434
	Secretaries	28	1	28	1	5/60	2	$28.90	$58
Medical Records	Secretaries	28	3.214286	90	1	5/60	8	$28.90	$231
Records Access	Supervisor	28	0.035714	1	1	5/60	1	$52.52	$53
Unduplicated Totals		--	--	209	--	--	34	--	$1,007
GRAND TOTALS		--	--	514		--	604	--	$25,214

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

• The cost estimate should be split into two components: (a) a total capital and start-up cost component (annualized over its expected useful life); and (b) a total operation and maintenance and purchase of services component. The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information. Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life 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 $121.⁶

Exposure above the action level, but below the PEL

Cost: 45 workers × 2 times per year × $121 = $10,890

Exposure above the PEL

Cost: 45 workers × 4 times per year × $121 = $21,780

Additional monitoring

Cost: 28 employers × 1 time per year × $121 = $3,388

Total cost for exposure monitoring: $36,058

Medical Exams

The Agency assumes that each medical exam, which includes the physician's written opinion, costs the employer $170⁷. Approximately 90 medical exams will be given each year at a total cost of $15,300.

Cost: 90 examinations × $170 = $15,300

The total costs is $36,058 exposure monitoring + $15,300 medical examinations = $51,358

14. Provide estimates of annualized cost to the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information. Agencies also may aggregate cost estimates from Items 12 13, and 14 in 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 increase in the burden hours from 535 to 604, a 69 hour increase. The increase is a result of updated information and analysis on the number of establishments and employees identified for this ICR. The currently approved ICR estimates a total of 24 establishments, and this proposed ICR estimates a total of 28 establishments. There is also an increase in the cost under Item 13 from $43,320 to $51,358, a total increase of $8,038. The cost increase results from an increase in the number of exposure monitoring samples and medical examinations.

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

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.

2. 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	Explanation
(A) Exposure Monitoring
1. Initial and Periodic Monitoring	240	270	30	$10,962	Adjustment increase due to an increase in the number of facilities.
2. Additional Monitoring	24	28	4	$1,137
3. Notification of Monitoring Results	5	0	-5	$0	This requirement is no longer contained in the Standard therefore it must be removed from Item 12.
(B) Written Compliance Program	72	84	12	$3,750	Adjustment increase due to an increase in the number of VC and PVC facilities.
(C) Respirator Program	0	0	0	$0	The burden associated with this provision is determined under the Respiratory Protection ICR (OMB Control Number 1218-0099).
(D) Emergency Plan	0	0	0	$0	This requirement applies 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
(1) Medical Exams	160	180	20	$8,127	Adjustment increase due to an increase in the number of facilities.
(2) Physician's Opinion	6	8	2	$231
(F) Communication of Hazards
Warning Signs and Labels	0	0	0	$0	Specific language is provided by OSHA for these labels, so no burden hours are attributed to this provision.
(G) Recordkeeping
1. Exposure Monitoring	21	25	4	$723	Adjustment increase due to an increase in the number of facilities.
2. Medical Records	6	8	2	$231
3. Access to Records	1	1	0	$53	No change in burden hours.
Totals	535	604	69	$25,214

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

2 VC permissible exposure limit: No worker may be exposed to vinyl chloride at concentrations greater than 1 part per million (ppm) averaged over any 8-hour period, and no worker may be exposed to VC at concentrations greater than 5 ppm averaged over any period not exceeding 15 minutes. Also, no worker may be exposed by direct contact with liquid VC. (29 CFR 1910.1017(c)(1)\, (c)(2), (c)(3).)

3SOURCE: IHS Chemical, Chemical Economics Handbook (CEH) Marketing Research Report, Polyvinyl Chloride (PVC) Resins (2017) and CEH Product Review, Vinyl Chloride Monomer (2017).

4As discussed the Agency estimates that there are, on average, 148 workers in each VC facility, 178 workers in each PVC facility, 40 workers in each non-vinyl facility, and 178 workers at facilities producing both substances. Therefore, the total number of workers in the 6 VC facilities is 888; the total number of workers in the 14 PVC facilities is 2,492; the total number of workers in the 2 other non-vinyl facilities is 80; and the total number of workers in the 6 facilities producing both substances is 1,068.

5 The Vinyl Institute suggested modifying the language to “OSHA also assumes another 1% of workers have ambient exposures (without considering the benefit of respiratory protection) above the PEL”. The Agency has not adopted this suggestion, as being exposed above the PEL triggers exposure monitoring (and other provisions) regardless of whether the worker is already using a respirator. Only after showing that work practices and engineering controls are infeasible can the employer rely on respirator use, and never with respect to exposure monitoring. In addition, “ambient exposure” is not a phrase that is defined in the standard.

6 The Consumer Price Index (CPI) indicated a 5.1% increase in the price of professional medical services from 2014 to 2016. The previous ICR estimated that the cost for the badge and lab analysis was $115; given the 5.1% increase in the price of professional medical services, it was assumed that the cost of exposure monitoring increased by 5.1% as well. Source: https://www.bls.gov/cpi/data.htm.

7The previous ICR estimated that the cost for each medical exam was $162. Given the 5.1% increase in the price of professional medical services from 2014 to 2016, it was assumed that the cost of each medical exam increased by 5.1% as well. Source: https://www.bls.gov/cpi/data.htm.

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