SUPPORTING STATEMENT FOR THE INFORMATION COLLECTION
REQUIREMENTS IN THE CADMIUM IN GENERAL INDUSTRY STANDARD


blackBALL Federal Register [09/30/1998] #63:52298-52300
Supporting Statement for the Information Collection Requirements in
The Cadmium in General Industry Standard


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 of 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."

The OSH Act contains specific statutory language for toxic substances. Thus, as appropriate, health standards are required to include provisions for monitoring and measuring employee exposure, medical examinations or other tests, control methods and personal protective equipment, and the use of labels or other appropriate forms of warning to ensure that employees are apprised of hazards, relevant symptoms and treatment, as well as precautions for safe use or exposure [Section (6)(b)(7) OSH Act]. In addition, the Act specifically mandates the issuance "of 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 [Section (8)(c)(1),(c)(3) OSH Act].

Pursuant to its statutory authority, OSHA promulgated a health standard governing employee exposure to cadmium (General Industry 29 CFR 1910.1027, Maritime 1915.1027, Agriculture 1928.1027). The basis for this standard is a determination of the Assistant Secretary for Occupational Safety and Health, that occupational exposure to cadmium poses a hazard to workers. Cadmium exposure causes lung cancer, prostrate cancer, non-malignant respiratory disease, acute pneumonitis, fever and chest pain, severe weakness, coughing and tightness of the chest, and kidney disease. The standard's information collection requirements are fully discussed in section 2 and 12.

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  [§1910.1027(d)]

Initial

Employers are required to perform initial monitoring in order to determine the extent of exposure in their workplace. Initial monitoring assists employers in identifying areas of operation that may require additional efforts to reduce exposure and 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 employees from over exposure. If the initial monitoring exceeds the standard's action level, then the employer must conduct periodic monitoring.

Periodic

Periodic monitoring are appropriate because relative minor changes in the process, materials or environmental conditions might change the 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 employee of the continued need to protect against the hazards which could result from employee's over exposure.

The collection of exposure monitoring will also enable the examining physician to be informed of the existence and extent of potential sources of occupational diseases.

Additional Monitoring

Under certain circumstances such as accidental spills, leaks, the employer is required to perform additional monitoring after such incident has been corrected. Such monitoring ensures that the area is safe or alerts the employer that protection may still be needed.

Objective Data for Exempted Operations

Employers may be able to rely on objective data in place of initial monitoring to minimize the burden of initial monitoring where the employer can demonstrate insignificant amounts of cadmium are present in the workplace and the potential for exposure above the Action Levels does not exist.

Employee Notification of Results

Employers are required to post and individually inform employees of their monitoring results. Posting enhances the collective knowledge in the workplace of employee exposures, which in turn enhances each employee's understanding of his/her own exposure. Thus, each notification performs a different function. Individual written notice assures that each employee is notified. Posting the results facilitates other employees, their designated representatives, supervisor and employers in becoming aware of exposure levels within the workplace.

Compliance Program  [§1910.1027(f)(2)]

Employers are required to establish, and implement a written program when employees are exposed above insert substance PELS. This plan describes the methods the employer will use to reduce employee exposure to or below the PELS in their workplaces. The purpose of requiring an employer to establish a written compliance program is to effectively promote required compliance with the standard's Permissible Exposure Limits. The written program requirement commits the employer to evaluating employee exposure and setting down an organized and complete plan of reducing employee exposure to the permissible exposure limits. The plan also provides employees, and their designated representatives, a resource to ensure that all appropriate protective steps will be taken to protect them from hazardous exposure.

Employers must also annually review and/or revise the plan as needed when exposures are above either PELs. Annual review, or revision as necessary, of the compliance plan ensures that the employer attempts to improve workplace controls to fully comply with the standard.

Respiratory Protection  [§1910.1027(g)]

Respiratory Program

When respirators are required, the employer must establish a respiratory protection program in accordance with 29 CFR 1910.134 (b)(d), (e) and (f). 29 1910.134 (b) and (e) require that written standard operating procedures governing the selection and use of respirators be established as well as covering safe use of respirators in dangerous atmospheres that might be encountered in normal operations or in emergencies. The purpose of these requirements are to ensure that employers establish a standardized procedure for selecting, using, and maintaining respirators for each workplace where respirators will be used. Developing and writing down procedures requires employers to think through just how all of their requirements of the respiratory standard will be met in their workplace.

Respirator Fit Testing

Employers are required to maintain a record of the name of the employee; type, brand, and size of respirator; and date of test. When Quantitative Fit Testing is used, the fit factor, strip chart or other recording of the results of the test, shall also be maintained. This record shall be kept until the next fit test is administered. A record is necessary to enable OSHA to determine compliance by verifying that an employee has been fit tested before first starting respirator use and as necessary; and that the tested employee passed the qualitative fit test for the assigned protection factor required; that the quantitative fit test was correctly performed and the fit factor calculated properly, and that the respirator model and size as determined during fit testing are the same as being used by that employee in the workplace. In addition, employers may use fit testing information in selecting respirator types for re-testing respirator fit.

Emergency Situations  [§1910.1027(h)]

The standard requires employers to develop and implement a written plan for dealing with emergencies involving substantial release of cadmium. Emergency plans are necessary to direct employees to act in ways that maximize their personal protection and minimize the hazard in the event of an emergency.

Notifying the Laundry  [§1910.1027(i)(3)(v)]

The standard requires that employers label contaminated protective clothing and equipment that is to be removed from the workplace. Further employers are to notify the laundry of the potential harmful effects of cadmium. By providing this information to the person doing the laundry, they can be protected from the potentially harmful effects of cadmium.

Medical Surveillance  [§1910.1027(1)]

The standard would require that employees whose duties require them to be potentially exposed be provided annual physical examinations.

Medical Examinations

Medical examinations and the related information collection requirements provide continuous monitoring of the health of potentially exposed employees. Records of medical examinations are used by physicians who must periodically examine employees exposed to cadmium. Without records of previous medical examinations, the physician may not be able to determine whether an employee has suffered adverse health effects since his or her last examination. Further, when symptoms of organic damage appear, the physician often needs information as to 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 are also designed so that employees can determine whether or not treatment is needed for occupational exposures.

The maintenance period for records regarding employee health is necessary because of the lengthy latency periods associated with the manifestation of disease due to exposure to cadmium.

Information Provided to Physician

Making the required information available to the physician will aid in the evaluation of the employee's health and fitness for particular cadmium exposed job assignment.

Physician's Written Opinion

The purpose in requiring the employer to obtain a written opinion from the examining physician is to provide the employer with a medical basis to aid in the determination of initial placement of employees and to assess the employee's ability to use protective clothing and equipment. The physician's opinion will also provide information to the employer as to whether the employee maybe suffering from overexposure cadmium. The requirement that a physician's opinion be in written form will ensure that employers have had the benefit of the information.

The requirement that an employee be provided a copy of the physician's written opinion will ensure that the employee is informed of the results of the medical examination. The requirement that the physician sign the opinion is to ensure that the information that is given to the employer has been seen and read by the physician.

Medical Removal Protection (MRP)

This requires that employers provide follow-up biological monitoring quarterly and follow-up medical examinations semi-annually until in a written medical opinion the examining physician determines that either the employee may be returned to his/her former job status as specified under or the employee is permanently removed from excess cadmium exposure. This provision is to remedy the rare cases of cadmium over-exposure.

Communication of Cadmium Hazards  [§1910.1027(m)]

Warning Signs

The employers are required to demarcate regulated areas using warnings signs at such a distance from the regulated area that employees may read the signs and take necessary protective steps. Posting warning signs serve to warn employees, who may otherwise not know, that they are entering a regulated area. Such signs would warn employees that entry is permitted only if the employee is authorized and there is a specific need to enter the area. Warning signs will also supplement the training which employees receive under this standard.

Warning Labels

Employers shall affix labels to any material/products containing cadmium. Labels shall be used in accordance with CFR 1910.1200 (1218-0072) OSHA's Hazard Communication Standard.

Warning labels assure that downstream employers and employees are informed of the associated hazards with cadmium and that special practices may need to be implemented to insure against exposure. Furthermore, hazard labels alert other employers who, in the absence of such labels, might not know that cadmium is present in their workplace and that they have incurred obligation of complying with the standard.

Employee Information and Training

Training is essential to inform employees of the hazards to which they are exposed and to provide employees with the necessary understanding of the degree to which they themselves can minimize the health hazard potential. Training serves to explain and reinforce the information presented to employees on signs and labels. These written forms of information and warning will be successful and relevant only when employees understand the information presented and are aware of the actions to be taken to avoid or minimize exposures.

Training provides information to the employee to enable them to be able to recognize how and where he or she might be occupationally exposed and what steps should be taken to limit exposure. Workers must be provided information on location, use, work practices.

Recordkeeping  [§1910.1027(n)]

Exposure Monitoring and Medical Records

The standard requires employers to maintain employee exposure and medical records. Medical and monitoring records are maintained for employee disclosure and are designed to provide valuable information to both the employee and the employer. The medical and monitoring records required by this standard will aid the employee and his/her physician in determining whether or not treatment is needed for occupational exposure to cadmium and what level of treatment is necessary. The employer benefits by keeping these records, since the information will enable the employer to better ensure that employees are not being overexposed; such information may alert the employer that steps must be initiated in order to reduce exposures. The standard requires that exposure records be kept for at least 30 years and that medical records be kept for the duration of employment plus 30 years. It is necessary to keep these records for extended periods of time because of the long latency period commonly associated with carcinogenesis. Cancer often cannot be detected until 20 or more years after first exposure.

Objective Data

The purpose of requiring an employer to document objective data determinations and retain them is to discourage abuse of this provision since employees and their representatives are permitted access to this information. Access enables employees and their representatives to ensure that the exemption determination is a reasonable one, thereby encouraging use of objective data determinations only in cases where the data warrant such use. Maintaining a record of the objective data determinations will permit OSHA to ascertain whether compliance with the standard has been achieved.

Training Records

Employers are required to maintain employee's training records for one year after the training. Maintaining training programs/materials provides a resource for an employee to refresh his or her training should they need it during the year. Retaining records of training demonstrates to OSHA, that the employer has been conducting annual training.

Availability

The employer, upon request, shall make any exposure and medical records available for examination and copying to affected employees, former employees, designated representatives, in accordance with 29 CFR 1910.1020(a) through (e) and (g) through (i). Access is necessary to yield both direct and indirect improvements in the detection, treatment, and prevention of occupational exposure to cadmium.

Information made available to OSHA in accordance with this standard is used to ensure that employers are complying with the standard and that protection of employees exposed to cadmium is provided to the full extent required. Occupational Safety and Health compliance officers may examine the records for this purpose when conducting inspection and may rely upon these records to determine the adequacy of compliance programs. Failure to have access to this information would significantly impair OSHA efforts to protect the health of employees exposed to cadmium in the workplace.

Federal Transfer

Under certain circumstances, employers are required to transfer records to NIOSH. Records that have been transferred may be used for research purposes. In addition, by having employee records submitted to NIOSH, NIOSH serves as a repository. Employees may then be able to access their records if needed for health or other reasons.

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 improved information technology whenever appropriate when making, keeping and preserving the required records. The standard is written in performance language, i.e., in term of what data must be collected rather then how data must be collected.

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 2 above.

The information required to be collected and maintained is specific to each employer and employee involved and is not available or duplicated by another source. The information required by this standard is available only from employers. At this time, there is no indication that any alternate source is available.

5. If the collection of information impacts small businesses or other small entities (Item 5 of OMB Form 83-I), describe any methods used to minimize burden.

The burden of these requirements is an equal obligation for employers who have establishments or operations in which exposure could occur. Because of the manner in which the standard is written, employers can choose to respond to this requirement in a way that is best suited to their work environment. The requirements are based on performance, and compliance is judged accordingly. There are no set requirements for how the information is documented or maintained.

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 information collection frequencies specified by this standard are the minimum OSHA believes necessary to ensure that the employer and OSHA can effectively monitor the exposure and health status of employees working with cadmium.

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.

Within 15 working days after the receipt of the results of any monitoring performed, the employer shall notify each affected employee individually in writing of the results. In addition, within the same time period the employer shall post the results of the exposure monitoring in an appropriate location that is accessible to all affected employees. Whenever monitoring results indicate that employee exposure exceeds the PEL, the employer shall include in the written notice a statements that the PEL, has been exceeded and a description of the corrective action being taken by the employer to reduce employer exposure to or below the PEL.

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

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

Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every 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.

The nature of the rulemaking process provided opportunities for the public, industry, labor, and other interested federal and state agencies to provide input on all aspects of the standard including information requirements. The final rule was published on September 14, 1992.

As required by the Paperwork Reduction Act of 1995 (PRA-95), the Agency published a notice in the Federal Register (May 12, 1998, 63 FR 26211, Docket No. ICR 98-6) soliciting comments from the public and other interested parties on the information collection requirements contained in 29 CFR 1910.1027. No comments were received in response to this notice.

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

No payments or gifts will be provided 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 information that can be considered private, OSHA and NIOSH have taken steps to assure that the medical records data are kept confidential. Rule of agency practice and procedure governing OSHA access to employee 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 reason sons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons form whom the information is requested, and any steps to be taken to obtain their consent.

There are no provisions in this standard requiring that questions of a sensitive nature be asked; therefore, this question is not applicable.

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

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

  • If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens in Item 13 of OMB Form 83-I.

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

Exposure Profile

Specific Industry Sectors # Plants Total
EEs > AL
Only those
EEs > PEL

Ni-Cd Batteries 6 1500 1200
Zn/Cd Refining 5 1350 1080
Pigments 4 100 80
Stabilizers 5 200 160
Pb Smelting/Refining 4 400 400
Platers 400 300 100
Utilities 4000 3750 3750
Iron & Steel 120 10000 10000
Formulators Currently NA 700 4200 4200

Total 4544 17600 16770
Note:  Those industries that have at least one plant with slightly different requirements due to a legal settlement agreement have been marked in italics.


Cross Industry Occupations # EEs > AL # EEs > PEL

Chem Mixers 7931 5287
Electroplaters 665 332
Furnace Operators 2580 1720
Kiln/Kettle Op 126 126
Heat Treaters 363 260
Equipment Cleaners 117 47
Metal Machining 9652 9652
Painters 3397 2265
Repair/Utilities 17820 6237
Weld/Braze/Solders 14724 14724

Total 57374 40649


Information Collection Requirement Current OMB Inventory Requested Burden Hours Change Estimated Cost
Exposure Monitoring and Measurement 26,361 7,572 -18,789.00 $139,628
   Employee Notification 14,899 6,010 -8,889 $78,130
Compliance Program 16,366 1,637 -14,729 $37,913
Respirator Protection        
   Respirator Program 0 0 0 $0
   Fit Testing 20,853 39,517 18,664 $716,839
Emergency Situations 0 0 0 $0
Notifying the Laundry 890 0 -890 $0
Medical Surveillance        
   Medical Examinations 40,152 56,681 16,529 $1,011,189
   Biological Monitoring 292 292 $5,209
   Information Provided to Physician 6,188 6,115 -73 $79,495
   Physician's Written Opinion 6,188 6,115 -73 $79,495
   Medical Removal Protection 7 - -7 -
Communication of Cadmium Hazards        
   Signs and Labels 0 0 0 $0
   Employee Information & Training 0 18,278 18,278 $423,318
Recordkeeping        
   Exposure Monitoring Records & Retention 10,555 0 -10,555 $0
   Objective Data 922 0 -922 $0
   Medical Surveillance Records & Retention 12,496 0 -12,496 $0
   Training Records 4,308 5,220 912 $67,860
   Availability 50 734 684 $16,999
   Records Transfer 1 1 0 $13
TOTAL 160,236 148,172 -12,064 $2,656,088


Exposure Monitoring  [§1910.1027(d)(1)-(4)] All employers are required to make an initial determination of exposure level (by monitoring or use of other data) and based on that determination may have to conduct periodic or additional monitoring of the workplace. In the previous paperwork package, the information collection request, OSHA estimates the burden for the initial determination, a one-time task. OSHA is unaware of any new employers entering the workplace who would have employees exposed to cadmium. Hence, no burden is shown for initial determination.

Using the information from the regulatory impact analysis prepared for the cadmium final rule back in 1992 (the most recent data), OSHA is estimating the burden hours for periodic and additional monitoring that may be needed when employees are exposed to cadmium above the action level. OSHA estimates that 74,974 employees are in this category and that an industrial hygiene technician, earning $18.44 per hour, can monitor 10 employees with one sample. sample takes 30 minutes (.5 hour) to collect and mail out to the laboratory for analysis. Thus, the burden is as follows:

(74,974 Employees/10) x 2 Samples/yr x .5 hour = 7,497 Burden Hours
7,497 Burden Hours x $18.44 = $138,245

Additional Monitoring

The Agency estimates that approximately another 150 monitoring samples will need to be performed each year for both the specific industry sectors and the cross industry occupations.

150 Monitoring Samples x .5 hr = 75 Hours
75 Burden Hours x $18.44 = $1,383

Notification of Monitoring Results  [§1910.1027(d)(5)]

The Agency assumes that it will take five minutes of secretary time (.08 hour), at $13.00 per hour, to individually inform the employees in writing of the results of the exposure monitoring; in doing this, the secretary will also post a copy of the results in a centralized location. The Agency assumes that the time associated with posting a copy of the results is minimal after already completing the individual notification, thus no additional time is assumed. Included in this five minutes is the time to maintain the record as required in paragraph (n)(1). The Agency also assumes that the 150 additional samples will occur in 150 plants. Thus, the burden is as follows:

74,974 Employees x .08 = 5,998 Burden Hours
150 Plants x .08 = 12 Burden Hours
6,010 Burden Hours x $13 = $78,130

Compliance Program  [§1910.1027(f)(2)]

OSHA estimates that only 10% of these plants will need to revise their programs, and it will take an average of 1.5 hours of supervisory time, at $23.16 per hour, to annually to revise the compliance program.

4,244 Plants x 10% x 1.5 hours = 637 Burden Hours
637 Burden Hours x $23.16 = $14,753

According to the 1992 analysis, the ten cross industry occupations are represented in 50,000 firms, spread across 88 SIC codes. A written compliance plan is required for plants where exposures are above the PEL. The Agency estimates that 20% of the 50,000 plants must be covered by a written compliance plan, yielding 10,000 plants. Of these 10,000 plants, the Agency estimates that only 10% of them will need to revise their compliance programs. Because firms with cross industry occupation workers generally have limited cadmium exposures, the compliance plan is expected to be less extensive than plans for the specific industry sector plants, therefore, OSHA estimates it only takes one (1) hour to revise the written plan. Using the same wage information, the burden is as follows:

10,000 Plants x 10% x 1 hour = 1,000 Hours
1,000 Hours x $23.16 = $23,160

Respiratory Protection  [§1910.1027(g)]

Respirator Program  [§1910.1027(g)(3)]

The burden associated with this requirement is taken in the Respiratory Protection information collection request, OMB Number 1218-0099.

Respirator Fit Testing  [§1910.1027(g)(4)(v)]

OSHA assumes that only the additional number of employees required by the standard will use respirators, and not the total number of employees in each industry wearing respirators. This means that OSHA attributes only a portion of the employees exposed above the PEL to respirator use due directly to the cadmium ruling.

According to the Regulatory Impact Analysis (57 FR 42322), only 39,517 employees will require respiratory protection after implementation of the engineering controls. The Agency assumes that it takes 1 hour (30 minutes of employee time ($17.84 per hour) and 30 minutes for an in-house technician ($18.44 per hour)) to perform a fit test. This 1 hour includes the time needed to maintain the fit test record as stated in Appendix C. Thus the burden and costs are as follows:


39,517 Employees x 1 hour = 39,517 Burden Hours
39,517 Burden Hours x .5 x $18.44  = $364,347
39,517 Burden Hours x .5 x $17.84  = $352,492
  $716,839
Emergency Situations  [§1910.1027(h)]

The burden for emergency plans has been accounted for in the Hazard Communication Standard 1910.1200, OMB Number 1218-0072.

Notifying the Laundry  [§1910.1027(i)(3)(v)]

The Agency assumes that employers will not change laundries often. Thus, there will be no burden hours because laundries have already been notified.

Medical Surveillance  [§1910.1027(l)]

Medical Exams

This standard went into effect on September 14, 1992 and initial exams were to be performed at the latest by June 14, 1993. It is assumed that the initial examinations have occurred and there is no burden taken.

The standard states that employers must provide a medical exam to employees who are exposed to cadmium above the action level (74,974 Employees) once every two years. The Agency assumes that it will take 1.5 hours of employee time ($17.84 per hour) to have a medical exam (which includes 30 minutes of travel time). Thus, the burden and cost are as follows:

74,974 Employees/2 x 1.5 hours = 56,231 Burden Hours
56,231 Burden Hours x $17.84 = $1,003,161

Biological Testing

According to the 1992 analysis, there will be 3,500 additional tests (ß²-microglobulin, tests for cadmium in urine, tests for cadmium in blood) annually. The Agency estimates that it will take 15 minutes (.25 hour) for three biological tests.

3,500/3 Tests x .25 hour = 292 Burden Hours
292 Burden Hours x $17.84 = $5,209

Additional Exams

According to the 1992 analysis, there will be 300 additional medical exams. This 300 exams will cover exams due to the following: respirator use, emergencies, medical removal, multiple physician review, alternate physician determination, and termination of employment. Thus, the burden and cost are as follows:

300 Exams x 1.5 hours = 450 Burden Hours
450 Burden Hours x $17.84 = $8,028

Information Provided to Physician

The Agency assumes that information will be provided to the physician for all exams and tests. Since all three test are usually given at the same time, the Agency assumes that the information will be provided 3,500 tests/3 = 1167 times (rounded). Assuming that it will take 5 minutes (.08 hour) of secretarial time ($13.00 per hour) to provide this information to the physician, the burden and costs are as follows:

(74,974 + 1167 + 300) x .08 hour = 6,115 Burden Hours
6,115 Burden Hours x $13 = $79,495

Physician's Written Opinion

The Agency assumes that the employers will provided a copy of the physician's written opinion to the employee for all exams and tests. Since all three test are usually given at the same time, the Agency assumes that the information will be provided 3,500 tests/3 = 1167 times (rounded). It is estimated that 5 minutes (.08 hour) of secretarial time ($13.00 per hour) will be needed to comply with this requirement. Included in this five minutes is the time that it takes to maintain the record which is required in paragraph (n)(3). Thus the burden and costs are as follows:

(74,974 + 1167 + 300) x .08 hour = 6,115 Burden Hours
6,115 Burden Hours x $13 = $79,495

Communication of Cadmium Hazards  [§1910.1027(m)]

Since the standard specifies exactly what language should be used, there is no burden for warning signs and labels. Also, there is no burden for employers developing the training programs since creation of such training programs should have occurred, at the latest, by June 24, 1993.

Employee Training  [§1910.1027(m)(4)]

Since the standard requires annual training, all of the 365,566 potentially exposed employees will need to be trained. The Agency assumes that it will take a trainer 1 hour per session (20 employees per session) to deliver the training (45 minutes) and prepare the training materials (15 minutes). Thus the burden and costs are as follows:

(365,566 Employees/20) x 1 hour = 18,278 Burden Hours
18,278 Burden Hours x $23.16 = $423,318

Recordkeeping  [§1910.1027(n)]

Objective Data

The Agency is assuming that there will be minimal burden for employers to maintain objective data once such data has been developed. This is a one time burden, therefore, the Agency is not incurring any burden for this requirement.

Training Records

The total number of establishments having potentially exposed employees is 65,244. The Agency assumes that it will take a secretary ($13.00 per hour) 5 minutes per employer to maintain the training records. Thus the burden and costs are as follows:

65,244 Establishment x .08 hour = 5,220 Burden Hours
5,220 Burden Hours x $13 = $67,860

Availability

The standard requires that all records be kept, transferred, and made available in accordance with 29 CFR 1910.1020. During fiscal year 1996, OSHA performed 33 inspections. The Agency assumes that 10% of the affected employees will request to see his/her records. OSHA also assumes that it will take 5 minutes (.08 hour) of supervisory time to make records available to compliance officers during inspections and to employees and/ or his/her representatives.

33 Facilities x .08 hour = 3 Burden Hours
3 Burden Hours x $23.16 = $69

((74,974/10 x 2) + 150) + (74,974 + 1,167 + 300) x 10% x .08 hour = 731 Burden Hours
731 Burden Hours x $23.16 = $16,930

Transfer of Records

Since NIOSH has not received any cadmium records over the past three years, OSHA does not anticipate that any employers would either cease business operations without a successor or be required to transfer records to NIOSH during the period covered by this clearance. To account for any future transfer of records, one hour of secretarial time has been allocated for this activity at a cost of $13.

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 offer than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.
Exposure Monitoring

According to the 1992 analysis, a cost of $40 per sample is needed to analyze the exposure samples. Thus, the cost is as follows:

((74,974/10 x 2) + 150) x $40 = $605,792

Medical Surveillance

The Agency has estimated that the cost of a medical exam is $250. Thus, the cost is as follows:

(74,974 + 300) x $250 = $18,818,500

Biological Monitoring

The Agency has estimated that the cost of the three biological monitoring tests is $120. thus, the cost is as follows:

2,000 ß²-microglobulin tests x $80 = $160,000
750 tests for cadmium in urine x $60 = $45,000
750 tests for cadmium in blood x $60 = $45,000

TOTAL: $19,068,500

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.

The Federal Government may incur costs from two provisions contained in this request - Transfer of Records to NIOSH and time for an OSHA representative to review records during an inspection.

Transfer of Records to NIOSH Cost

Over the past year, NIOSH has not received any records. Therefore, there is no cost to the Federal Government associated with this provision.

Federal Inspections

The Agency assumes that a compliance officer who earns $25.56 per hour will take 10 minutes (.17 hour) to review the records. Therefore, the cost to the Federal Government related to inspections is as follows:

33 Inspections x $25.56 x .17 hour = $143

15. Explain the reasons for any program changes or adjustments reporting in Items.13 or 14 of the OMB Form 83-I.

The Agency is requesting that the current inventory of 160,236 Burden Hours be decreased by 12,064 hours to equal the new Requested Burden of 148,172 Burden Hours. The main reason for these changes are as follows:

Exposure Monitoring - Burden now taken for the population exposed above the action level

Employee Notification - Decreased based on the Exposure Monitoring population

Compliance Program - Burden taken for those employers revising their programs

Fit Testing - According to Revised Respiratory Protection Rule, time for fit testing changed to 30 minutes for employee and 30 minutes for technician totaling 1 hour

Emergency Situations - No Change

Notifying the Laundry - Assumption made that notification has already taken place and there will not be any changes in laundry services by employers, thus no burden is incurred.

Medical Examinations - Slight increase due to assumptions made in the economic analysis and increase time of medical exams

Biological Monitoring - Burden now calculated separately

Info. Provided to Physician/ - Slight reduction, dependent on the number of exams and tests Physician's Written Opinion

Medical Removal Protection - Burden incorporated into the medical exam provisions

Signs & Labels/Employee Info. & Training - Burden taken for annual employee training

Exposure & Medical Records - Burden incorporated into the "Notification of Results" and the "Physician's Written Opinion" provisions

Objective Data - Burden removed. One time burden

Training Records - Dependent on the number of affected employers

Availability - Based on the number of inspections

Records Transfer - No Change

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.

This collection of information will not have results that will be published for statistical use.

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.

The Collection of Information will display a currently valid OMB control number.

18. Explain each exception to the certification statement identified in Item 19. "Certification for Paperwork Reduction Act Submission," of OMB 83-I.

The Collection of Information does not request any exemptions from the certification statement identified in Item 19 "Certification for Paperwork Reduction Act Submissions": OMB Form 83-I.

B. Collection of Information Employing Statistical Methods

The agency should be prepared to justify its decision not to use statistical methods in any case where such methods might reduce burden or improve accuracy of results. When Item 17 on the Form OMB 83-I is checked "Yes", the following documentation should be included in the Supporting Statement to the extent that it applies to the methods proposed:

1. Describe (including a numerical estimate) the potential respondent universe and any sampling or other respondent selection methods to be used. Data on the number of entities (e.g., establishments, State and local government units, households, or persons) in the universe covered by the collection and in the corresponding sample are to be provided in tabular form for the universe as a whole and for each of the strata in the proposed sample. Indicate expected response rates for the collection as a whole. If the collection had been conducted previously, include the actual response rate achieved during the last collection.

2. Describe the procedures for the collection of information including:

  • Statistical methodology for stratification and sample selection,

  • Estimation procedure,

  • Degree of accuracy needed for the purpose described in the justification,

  • Unusual problems requiring specialized sampling procedures, and

  • Any use of periodic (less frequently than annual) data collection cycles to reduce burden.
3. Describe methods to maximize response rates and to deal with issues of non-response. The accuracy and reliability of information collected must be shown to be adequate for intended uses. For collections based on sampling, a special justification must be provided for any collection that will not yield "reliable" data that can be generalized to the universe studied.

4. Describe any tests of procedures or methods to be undertaken. Testing is encouraged as an effective means of refining collections of information to minimize burden and improve utility. Tests must be approved if they call for answers to identical questions from 10 or more respondents. A proposed test or set of tests may be submitted for approval separately or in combination with the main collection of information.

5. Provide the name and telephone number of individuals consulted on statistical aspects of the design and the name of the agency unit, contractor(s), grantee(s), or other person(s) who will actually collect and/or analyze the information for the agency.

The information collection requirements of the Cadmium in General Industry Standard do not employ statistical methods, therefore this section is not applicable.