SUPPORTING STATEMENT FOR THE INFORMATION COLLECTION REQUIREMENTS FOR
THE HAZARDOUS CHEMICALS IN LABORATORIES STANDARD
Federal Register [09/30/1998] #63:52298-52300
Agency Information Collection Activities: Proposed Collection; Comment Request;
Hazardous Chemicals in Laboratories Standard
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 OSHA's statutory authority, under Section (b) of the OSH Act, OSHA published a health standard governing occupational exposure to hazardous chemicals in laboratories (29 CFR 1910.1450). The basis for this standard is a determination of the Assistant Secretary for Occupational Safety and Health, that occupational exposure to hazardous chemicals poses a significant risk to workers. Exposure to these chemicals causes aplastic anemia, leukemia, multiple myeloma, tumors, colon and lung cancer, and death.
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.
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 monitoring would be 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.
Employee Notification of Results
Employers are required to either post or individually inform employees of their monitoring results either by posting the results or by individually notifying the employee. Notification ensures employees are notified of their results, and what corrective action the employer is going to take to ensure that employees are not overexposed.
Chemical Hygiene Plan [§1910.1450(e)]
Where hazardous chemicals are used in the workplace, the employer shall develop and carry out the provisions of a written Chemical Hygiene Plan. This plan shall include standard operating procedures relevant to the safety and health considerations to be followed when laboratory work involves the use of hazardous chemicals. It should also include the criteria that the employer uses to determine and implement control measures to reduce employee exposure to hazardous chemicals including engineering controls, the use of personal protective equipment and hygiene practices; particular attention shall be given to the selection of control measures for chemicals that are known to be extremely hazardous. As well as information involving employee training, fume hoods, medical surveillance, and designation of responsible personnel. The written plan requirement commits the employer to evaluating employee exposure and setting down an organized and complete plan of reducing employee exposure. 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.
Information and Training [§1910.1450(f)]
The standard requires employers to provide employees with information and training at the time of initial assignment and when necessary thereafter (determined by the employer). 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, labels and MSDS's. 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.
Medical Consultation and Medical Examinations [§1910.1450(g)]
The standard requires that employees whose duties require them to be potentially exposed be provided annual physical 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 hazardous chemicals. 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 hazardous chemicals.
Information Provided to Physician [§1910.1450(g)(3)]
Making the required information available to the physician will aid in the evaluation of the employee's health and fitness for each job assignment where potential exposure to hazardous chemicals exist.
Physician's Written Opinion [§1910.1450(g)(4)]
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 may be suffering from overexposure to hazardous chemicals. 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.
Use of Respirators [§1910.1450(i)]
The standard requires that where the use of respirators is necessary to maintain exposure below the PELs, the employer shall provide, at no cost to the employee, the proper respiratory equipment. Respirators shall be selected and used in accordance with the requirements in 29 CFR 1910.134. This is to make sure that before using respirators, employees are trained on how respirators work and how they should properly be used.
Exposure Monitoring and Medical Records [§1910.1450(j)(1)]
The standard requires that the employer 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 hazardous chemicals 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.
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 Hazardous chemicals 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 hazardous chemicals in the workplace. Employers must also make exposure monitoring and medical records available for examination and copying to affected employees, former employees, designated representatives and the Assistant Secretary, in accordance with 29 CFR 1920.
Federal Transfer [§1910.1450(j)(2)]
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 hazardous chemicals in laboratories.
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.
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 January 31, 1990.
As required by the Paperwork Reduction Act of 1995 (PRA-95), the Agency published a notice in the Federal Register (March 17, 1998, 63 FR 13073, Docket No. ICR 98-8) soliciting comments from the public and other interested parties on the information collection requirements contained in 29 CFR 1910.1450. 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. Rules 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.
Number of Potentially Exposed Employees: 934,000
Supervisory Wage Rate = $23.16
Employee Wage Rate = $17.84
Clerical Wage Rate = $13.00
|Information Collection Requirement||Current OMB
|Exposure Monitoring and Measurement||8,223||5,816||-2407||$134,699|
|Chemical Hygiene Plan||16,969||5,132||-11,837||$118,857|
|Information and Training||0||4,670||4,670||$108,157|
| Information Provided
|Physician's Written Opinion||4,079||5,978||1,899||$77,714|
|Use of Respirators||0||0||0||$0|
| Exposure Monitoring/
Exposure Monitoring [§1910.1450(d)]
OSHA assumes that each laboratory will be monitored at least once annually. The Agency also estimates that it will take about 10 minutes (.17 hour) for supervisors to distribute, collect and mail badges out for analysis. Thus the burden and cost is as follows:
34,214 Laboratories x .17 hour = 5,816 Burden Hours
5,816 Burden Hours x $23.16 = $134,699
Employee Notification of Monitoring Results [§1910.1450(d)(4)]
The Agency assumes that employers will post the monitoring results in an appropriate location. This will require 5 minutes (.08 hour) of secretarial time at $13.00 per hour to post the results. Included in this five minutes is the time to maintain the record as required in paragraph (j)(1) of the standard. Thus the burden and cost is as follows:
34,214 Laboratories x .08 hour = 2,737 Burden Hours
2,737 Burden Hours x $13.00 = $35,581
Chemical Hygiene Plan [§1910.1450(e)]
Since this provision of the regulation has been in effect since January 1991, it is assumed that the plans have already been developed; therefore, burden hours are being estimated for the time necessary to update only. The Agency assumes that out of the total number of labs, only 10% of the labs will need to update their plans and it will take approximately 1.5 hours of supervisory time to update each plan as necessary. Thus, the burden and cost are as follows:
34,214 Laboratories x 10% x 1.5 hours = 5,132 Burden Hours
5,132 Burden Hours x $23.16 = $118,857
Designated Areas [§1910.1450(e)(3)(viii)(A)]
The standard requires that employers, wherever appropriate, establish designated areas to provide employees with additional protection. This provision does not require any information to be neither recorded nor maintained, therefore no burden will be taken for this requirement.
Employee Information and Training [§1910.1450(f)]
The Agency assumes that 10% of the potentially exposed employees would be subject to the training requirements. This 10% includes training new employees and training employees for assignments involving new exposure situations. It will take a trainer 1 hour per session (20 employees per session) to deliver the training (45 minutes) and to prepare the training materials (15 minutes). Thus the burden and costs are as follows:
(934,000 x 10%)/20 x 1 hour = 4,670 Burden Hours
4,670 Burden Hours x $23.16 = $108,157
Medical Consultation and Medical Examinations [§1910.1450(g)]
The Agency estimates that only 8% of the total number of exposed employees will be impacted by the medical provision. Four percent of the employees at risk will need consultation, this takes about 15 minutes (.25 hour). Two percent of the employees at risk will need a examination, which takes about 1.5 hours (includes 30 minutes of travel time). Another 2% will have both a consultation and a medical examination lasting about 1.75 hours (includes 30 minutes of travel time). Thus the burden and costs, based on the employee wage rate of $17.84 per hour, are as follows:
934,000 Employees x 8% = 74,720 Employees Subject to Medical Surveillance
|934,000 Employees x 4% x .25 hour =||9,340 Burden Hours|
|934,000 Employees x 2% x 1.5 hour =||28,020 Burden Hours|
|934,000 Employees x 2% x 1.75 hour =||32,690 Burden Hours|
|70,050 Burden Hours|
70,050 Burden Hours x $17.84 = $1,249,692
Information Provided to Physician [§1910.1450(g)(3)]
The Agency estimates that it will take 5 minutes (.08 hour) of secretarial time, at $13 per hour, to provide the information to the physician for each exam and consultation. Thus, the burden and cost is as follows:
74,720 Employees x .08 hour = 5,978 Burden Hours
5,978 Burden Hours x $13.00 = $77,714
Physicians Written Opinion [§1910.1450(g)(4)]
The Agency estimates that it will take 5 minutes (.08 hour) of secretarial time, at $13 per hour, to provide the employee with a copy of the physician's written opinion for each exam and consultation. Included in this five minutes is the time that it takes to maintain the record which is required in paragraph (j)(1) of the standard. Thus, the burden and cost is as follows:
74,720 Employees x .08 hour = 5,978 Burden Hours
5,978 Burden Hours x $13.00 = $77,714
Hazard Identification [§1910.1450(h)]
No burden hours are attributed to these provisions, since the disposition of labels and MSDS's are accounted for in paragraph (b)(3)(i) and (ii) of 1910.1200, the Hazard Communication information collection request (1218-0072).
Use of Respirators [§1910.1450(i)]
No burden hours are attributed to these provisions, since the Agency assumes that laboratories are currently complying with the paperwork provisions of the Respiratory Protection Standard (1218-0099). Burden hours for training of employees designated to use the respirators in emergency situations is accounted for in the regular training sessions as specified in paragraph (f) of the standard (Employee Information and Training).
Exposure Monitoring and Medical Records [§1910.1450(j)(1)]
Burden for this requirement is now taken in the Notification of Monitoring Results and the Physician's Written Opinion sections of this information collection request.
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 29 inspections. The Agency assumes that 10% of the affected employees will request to see his/her records. OSHA also assumes that it will take the 5 minutes (.08 hour) of supervisory time to make records available to compliance officers during inspections and to employees and/or his/her representatives.
29 Facilities x .08 hour = 2 Burden Hours
2 Burden Hours x $23.16 = $46
934,000 x 10% x .08 hour = 7,472 Burden Hours
7,472 Burden Hours x $23.16 = $173,052
Transfer of Records [§1910.1450 (j)(2)]
During fiscal year 1996, NIOSH has reported 665 employee records from 7 employers. It is estimated that it will take a secretary earning $13.00 per hour one hour to prepare and send records to NIOSH. Thus the burden and cost are as follows:
7 Employers x 1 hour = 7 Burden Hours
7 Burden Hours x $13.00 = $91
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.
The Agency has estimated that a cost of $25 per sample is needed to analyze the exposure samples. Thus, the cost is as follows:
34,214 Samples x $25 = $855,350
The Agency has estimated that the cost of a medical exam is $130. Thus, the cost is as follows:
74,720 Exams/Consultations x $130 = $9,713,600
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 2 past year, NIOSH has received 665 employee records from 7 employers. It will cost $4.50 per record to process the records. The total cost for processing these records is as follows:
665 Employee Records x $4.50 Per Record = $2,993
The Agency assumes that a compliance officer who earns $24.00 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:
29 Inspection x $24.00 x .17 hour = $118
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 OMB inventory of 106,752 Burden Hours be increased by 1,090 hours to equal the New Requested Burden of 107,842 Burden Hours.
Since promulgation of this standard, new technological advances in personal protective equipment have resulted in reducing the level of exposure to employees. Ultimately, this has resulted in a decrease in the number of medical exams.
The reasons for the changes are as follows:
|Exposure Monitoring||-||No based on laboratory.|
|Notification of Monitoring Results||-||Dependent on the number of laboratories thus a slight decrease. Included the recordkeeping time.|
|Chemical Hygiene Plan||-||Burden taken for updates. Time element remains consistent with other HSP ICRs|
|Designated Areas||-||Not subject to PRA95|
|Information and Training||-||Burden taken for 10% of all potentially exposed employees.|
|Medical Examinations||-||Decreased due to a decrease in the level of exposure to employees.|
|Info. to Physician & Physician's Written Opinion||-||Removed compliance rates from equations. Now based on numbers from the medical exams provision. Included the recordkeeping time into the Physician's Written Opinion requirement|
|Hazard Identification & Use of Respirators||-||No Change|
|Exposure Monitoring and Medical Records||-||Overall decrease due to the changes in the monitoring and medical exam equations.|
|Availability||-||Increased because all employees exposed can request to see exposure monitoring or medical records|
|Transfer of Records||-||Increased because NIOSH did receive 665 records from 7 companies.|
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.
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 Hazardous Chemicals in Laboratories Standard do not employ statistical methods, therefore this section is not applicable.