Ss_1218-0092(07-22-09)

SUPPORTING STATEMENT FOR THE
INFORMATION COLLECTION REQUIREMENTS IN THE
LEAD IN GENERAL INDUSTRY STANDARD (29 CFR 1910.1025)1
(OMB CONTROL NO. 1218-0092 (March 2009))
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 main objective of the Occupational Safety and Health Act (OSH Act) is to "assure so far as
possible every working man and woman in the Nation safe and healthful working conditions and
to preserve our human resources" (29 U.S.C. 651). To achieve this objective, the OSH Act
specifically authorizes "the development and promulgation of occupational safety and health
regulations" (29 U.S.C. 651).
To protect employee health, the OSH Act authorizes the Occupational Safety and Health
Administration (OSHA) to develop standards that provide for "monitoring or measuring
employee exposure" to occupational hazards and "prescribe the type and frequency of medical
examinations and other tests which shall be made available [by the employer] to employees
exposed to such hazards in order to most effectively determine whether the health of such
employees is adversely affected by such exposure" (29 U.S.C. 655). In addition, the OSH Act
mandates that "[e]ach employer shall make, keep and preserve, and make available to the
Secretary [of Labor] . . . such records regarding [his/her] activities relating to this Act as the
Secretary . . . may prescribe by regulation as necessary or appropriate for the enforcement of this
Act or for developing information regarding the causes and prevention of occupational accidents
and illnesses" (29 U.S.C. 657). In addition, the OSH Act directs OSHA to "issue regulations
requiring employers to maintain accurate records of employee exposure to potentially toxic
materials or other harmful physical agents which are required to be monitored and measured,"
and further specifies that such regulations provide "for each employee or former employee to
have access to such records as will indicate [their] own exposure to toxic materials or harmful
physical agents” (29 U.S.C. 657). The OSH Act states further that "[t]he Secretary . . . shall . . .
prescribe such rules and regulations as [he/she] may deem necessary to carry out [his/her]
responsibilities under this Act, including rules and regulations dealing with the inspection of an
employer's establishment" (29 U.S.C. 651).
Pursuant to its statutory authority, OSHA promulgated a health standard governing employee
1

The purpose of this supporting statement is to analyze and describe the burden hours and costs associated with
provisions of the Lead in General Industry Standard that contain paperwork requirements; this supporting statement
does not provide information or guidance on how to comply with, or how to enforce, the Standard.

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exposure to lead for general industry (29 CFR 1910.1025). The standard applies to all
operations where exposure to lead may occur, except the construction and agricultural sectors.
The purpose of this regulation is to provide protection for employees from the health effects
associated with occupational exposure to lead. In general, the standard requires employers to
monitor employee exposure to lead, to take action to reduce employee exposure to the
permissible exposure limit (PEL), to monitor employee health, to train employees about lead
hazards, and to provide employees with information about their exposures and the health effects
of lead. The specific information collection activities necessary to fulfill the above requirements
are described in items 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 (§ 1910.1025(d))
The exposure monitoring and employee notification requirements of this standard protect the
health and safety of employees who work with lead by providing both the employer and the
employee with information regarding exposures to this toxic substance.
Exposure Measurement (§ 1910.1025(d)(1)-(7))
Employers covered by the standard must determine if any employee may be exposed to lead at or
above the action level (“AL”)2. Employers must monitor employee exposures and base initial
determinations on the employee exposure monitoring results and any of the following relevant
considerations: (A) Any information, observations, or calculations which would indicate
employee exposure to lead; (B) Any previous measurements of airborne lead; and (C) Any
employee complaints of symptoms which may be attributable to exposure to lead. Employers
may use representative sampling.
If the employer makes an initial determination that no employee is exposed to lead at or above
the action level, the employer must make a written record of the determination. The records
must include information specified in paragraph (d)(3), and include the date of determination,
location within the worksite, and the name and social security number of each employee
monitored.
The standard requires employee monitoring at least every 6 months when 8-hour time-weighted
(TWA) average exposures are at or above the action level but below the permissible exposure
limit (PEL) of 50 micrograms per cubic meter of air (50 ug/m3). When employee exposures are
in excess of the PEL, monitoring must be performed quarterly. When employee exposures are
reduced to below the action level, monitoring may be discontinued.

2

Action Level means employee exposure, without regard to the use of respirators, to an airborne
concentration of lead of 30 micrograms per cubic meter of air (30ug/m3) averaged over an 8-hour period.

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In the event of a production, process, control, or personnel change which may result in new or
additional exposures to lead, or whenever the employer has another reason to suspect a change
that may result in new or additional exposures to lead, additional monitoring in accordance with
the standard must be conducted by the employer.
Employee Notification of Monitoring Results (§ 1910.1025(d)(8))
After employers conduct exposure monitoring for lead, they must notify each employee of their
exposure monitoring results within 15 working days after receiving these results. Employers
may notify employees either individually in writing or by posting the monitoring results in an
appropriate location that is accessible to the employees. In addition, if the exposure monitoring
results show that an employee’s exposure exceeds the PEL, the employer must inform the
exposed employee of the corrective action the employer is taking to prevent such overexposure,
and the schedule for completion of this action. Notification provides employees with
information about the efforts the employer is taking to lower their lead exposures and to furnish
them with a safe and healthful workplace in accordance with section 8(c)(3) of the Act.
Compliance Program (§ 1910.1025(e)(3))
Written Compliance Program (§ 1910.1025(e)(3)(i)(iv))
The standard requires that employers establish and implement a written compliance program to
reduce employee exposures to or below the PEL solely by means of engineering and work
practice controls. These written plans must be revised and updated annually to reflect the current
status of the program.
The compliance plans must include at least the following information: (1) a description of each
operation in which lead is emitted, e.g., machinery used, material processed, controls in place,
crew size, employee job responsibilities, operating procedures, and maintenance practices; (2) a
description of the specific means that will be employed to achieve compliance with the lead
standard, including engineering plans and studies used to determine methods selected for
controlling exposure to lead; (3) a report of the technology considered in meeting the PEL; (4)
air monitoring data that document the source of lead emissions; (5) a detailed schedule for
implementation of the program, including documentation such as copies of purchase orders for
equipment, construction contracts, etc.; (6) a work practice program that includes items required
under paragraphs (g) "Protective Work Clothing and Equipment", (h) "Housekeeping", and (i)
"Hygiene facilities and practices" of this regulation; (7) an administrative control schedule, if
applicable; and (8) other relevant information.
Written compliance plans must be submitted upon request to OSHA and to the National Institute
for Occupational Safety and Health (NIOSH), and must be available at the worksite for
examination and copying by representatives of these government officials, employees, and
authorized employee representatives.
The purpose of requiring an employer to establish a written compliance program is to effectively
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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.
Administrative Controls (§ 1910.1025(e)(5)(i)-(iii))
If administrative controls are used as a means of reducing employees' TWA exposure to lead, the
employer must establish and implement a job rotation schedule that includes the following
information: (1) name or identification number of each affected employee; (2) duration and
exposure levels at each job or work station where each affected employee is located; and (3) any
other information that may be useful in assessing the reliability of administrative controls to
reduce exposure to lead.
Respirator Program (§ 1910.1025(f)(2))
Where the use of respiratory protective equipment is required or permitted under the provisions
of the lead standard, the employer must institute a respirator program in accordance with 29 CFR
1910.134(b) through (d) (except (d)(1)(iii)), and (f) through (m). 29 CFR 1910.134 (b) and (e)
require that written standard operating procedures governing the selection and use of respirators
be established. 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 requires employers to think
through just how all of their requirements of the respiratory standard will be met in their
workplace.
Notifying the Laundry (§ 1910.1025(g)(2)(vi))
The standard requires employers to inform, in writing, any person who launders or cleans
protective clothing or equipment of the potentially harmful effects of exposure to lead.
By providing this information to the person doing the laundry, they are protected from the
potentially harmful effects of lead.
Warning Labels (§ 1910.1025(g)(2)(vii))
Employers must affix labels to containers of contaminated protective clothing and equipment
required by paragraph (g)(2)(v). The labels must state, CAUTION: CLOTHING
CONTAMINATED WITH LEAD. DO NOT REMOVE DUST BY BLOWING OR SHAKING.
DISPOSE OF LEAD CONTIMINATED WASH WATER IN ACCORDANCE WITH
APPLICABLE LOCAL, STATE, OR FEDERAL REGULATIONS.
Warning labels inform downstream employees and employers of the hazards associated with
lead, and that they may need to implement special practices to prevent or reduce lead exposure.
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Furthermore, the labels alert downstream employers that they may have an obligation to protect
their employees under the Standard.
Medical Surveillance (§ 1910.1025(j))
The standard requires that the employer institute a medical surveillance program for all
employees who are or may be exposed to lead above the action level (30 ug/m3) for more than 30
days per year.
Biological Monitoring (§ 1910.1025(j)(2)(i), (ii), (iv))
(1)

Initial Blood Lead and ZPP Level Sampling and Analysis (§ 1910.1025(j)(2)(i))

The employer must make available at least every 6 months biological monitoring in the form of
blood sampling and analysis for lead and zinc protoporphyrin (ZPP) levels to each employee
who is or may be exposed to lead above the action level (30 ug/m3) for more than 30 days per
year.
At least every 2 months, such lead and ZPP monitoring must be made available to each
employee whose last blood sampling and ZPP analysis indicates a blood lead level at or above
40 micrograms lead per 100 grams of whole blood (40 ug/100 g). This frequency of sampling
must continue until two consecutive blood samples and ZPP analyses indicate a blood lead level
below 40 ug/100 g. Lead and ZPP monitoring must be conducted at least monthly during the
removal period for each employee removed from exposure to lead due to an elevated blood lead
level.
(2)

Follow-up Blood Sampling Tests (§ 1910.1025(j)(2)(ii))

Whenever the results of a blood lead level test indicate that an employee's blood lead level
exceeds the numerical criterion for medical removal under paragraph (k)(1)(i)(A), the employer
must provide a second (follow-up) blood sampling test within 2 weeks after the employer
receives the results of the first blood sampling test.
(3)

Employee Notification of Biological Monitoring Results (§ 1910.1025(j)(2)(iv))

Within 5 working days after the receipt of biological monitoring results, the employer must
notify in writing each employee whose blood lead level exceeds 40 ug/100 g. The employer
must inform the affected employee of the fact that the standard requires temporary medical
removal with Medical Removal Protection benefits when an employee's blood lead level exceeds
the numerical criterion for medical removal.
Medical Examinations and Consultations (§ 1910.1025(j)(3))
The employer must provide medical examinations and consultations to each employee who is or
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may be exposed to lead above the action level (30 ug/m3) for more than 30 days per year. Such
medical examinations and consultations must be provided in accordance with the following
schedule: (1) at least annually for each employee for whom blood sampling tests, conducted at
any time during the preceding 12 months, indicated a blood lead level at or above 40 ug/100 g;
(2) prior to assigning the employee, for the first time, to an area in which airborne concentrations
of lead are at or above the action level; (3) as soon as possible upon notification, by an
employee, either that the employee has developed signs or symptoms associated with lead
intoxication, that the employee desires medical advice concerning the effects of current or past
exposure to lead on the employee's ability to produce a healthy child, or that the employee has
demonstrated difficulty in breathing during a respirator fit test or during respirator use; and (4) as
medically appropriate for each employee who is either removed from exposure to lead due to a
risk of sustaining material impairment to health or is otherwise limited pursuant to a final
medical determination.
Medical examinations conducted pursuant to the standard must include the following elements:
(1)

A detailed work history and a medical history, with particular attention to past lead
exposure, personal habits (smoking and hygiene), and past gastrointestinal,
hematologic, renal, cardiovascular, reproductive, and neurological problems.

(2)

A thorough physical examination, with particular attention to teeth, gums, and
hematologic, gastrointestinal, renal, cardiovascular, and neurological systems.
Pulmonary status should be evaluated if respirators will be used.

(3)

A blood pressure measurement.

(4)

A blood sample and analysis which determines blood lead level; hemoglobin and
hematocrit determinations, red cell indices, and examination of peripheral smear
morphology; zinc protoporphyrin; blood urea nitrogen; and serum creatinine.

(5)

A routine urinalysis with microscopic examination.

(6)

Any laboratory or other test that the examining physician deems necessary by sound
medical practice.

(7)

If requested by an employee, the medical examination shall include pregnancy testing
or laboratory evaluation of male fertility.

(1) Multiple Physician Review Mechanism (§ 1910.1025(j)(3)(iii))
Under the standard's multiple physician review provisions, if the employer selects the initial
physician who conducts any medical examination or consultation provided to an employee, the
employee may designate a second physician: (a) to review any findings, determinations, or
recommendations of the initial physician; and (b) to conduct such examinations, consultations,
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and laboratory tests as the second physician deems necessary to facilitate this review.
The employer must promptly notify an employee of the right to seek a second medical opinion
after each occasion on which an initial physician conducts a medical examination or
consultation.
Information Provided to Examining and Consulting Physicians (§ 1910.1025(j)(3)(iv))
The lead standard requires that the employer provide the following information to the initial
physician conducting a medical examination or consultation: (a) a copy of the lead standard,
including all appendices; (b) a description of the affected employee's duties as they relate to the
employee's exposure; (c) the employee's exposure level or anticipated exposure level to lead and
to any other toxic substance (if applicable); (d) a description of any personal protective
equipment used or to be used; (e) prior blood lead determinations; and (f) all prior written
medical opinions concerning the employee in the employer's possession or control.
The standard further requires that the employer must also provide the aforementioned
information to the second and third physician conducting a medical examination or consultation
in accordance with the standard's multiple physician review provisions, upon request of the
second or third physician or the employee.
Written Medical Opinions (§ 1910.1025(j)(3)(v))
From each examining or consulting physician, the employer must obtain and furnish to the
employee a copy of a written medical opinion that contains the following information: (a) the
physician's opinion as to whether the employee has any detected medical condition that would
place the employee at increased risk of material impairment of health from exposure to lead; (b)
any recommended special protective measures to be provided to the employee, or limitations to
be placed upon the employee's exposure to lead; (c) any recommended limitation upon the
employee's use of respirators, including a determination of whether the employee can wear a
powered air-purifying respirator if a physician determines that the employee cannot wear a
negative-pressure respirator; and (d) the results of the blood lead determinations.
Instructing Examining and Consulting Physician (§ 1910.1025(j)(3)(v)(B))
The employer must instruct each examining and consulting physician to: not reveal either in the
written opinion, or in any other means of communication with the employer, findings, including
laboratory results, or diagnoses unrelated to an employee’s occupational exposure to lead; and to
advise the employee of any medical condition, occupational or nonoccupational, which dictates
further medical examination or treatment.
Chelation (§ 1910.1025(j)(4)(ii))
If therapeutic or diagnostic chelation is to be performed on any person whom the employer
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retains, employs, supervises, or controls, the employer must ensure that it is performed under the
supervision of a licensed physician, in a clinical setting, with thorough and appropriate medical
monitoring, and that the employee is notified, in writing, prior to its performance.
Medical Removal Protection (§ 1910.1025(k)(1))
(a) Temporary Removal Due to Elevated Blood Lead Levels (§ 1910.1025 (k)(1)(i))
Paragraph (k)(1)(i)(A) states that on each occasion that a periodic and a follow-up blood
sampling test indicate that employees blood lead level is at or above 60 ug/, the standard requires
that the employer remove an employee from work having an exposure to lead at or above the
action level. Paragraph (k)(1)(i)(B) requires that on each occasion that the average of the last
three blood sampling tests conducted pursuant to this standard (or the average of all blood
sampling tests conducted over the previous six months, whichever is longer) indicates that the
employee's blood lead level is at or above 50 ug/100, except that an employee need not be
removed if the last blood sampling test indicates a blood lead level at or below 40 ug/100 g.
Temporary Removal Due to a Final Medical Determination (§ 1910.1025(k)(1)(ii))
The standard requires an employer to remove an employee from work having an exposure to lead
at or above the action level (30 ug/m3) on each occasion that a final medical determination
results in a medical finding, determination, or opinion that the employee has a detected medical
condition that places the employee at increased risk of material impairment to health from
exposure to lead.
Return of the Employee to Former Job Status (§ 1910.1025 (k)(1)(iii))
The employer must return an employee to his or her former job status under the following
conditions:
Circumstances of Employee Removal

Circumstances of Employee Return

(k)(1)(iii)(A)(1)
Blood lead level at or above 60 ug/100 g
whole blood or an average blood level at or
above 50 ug/100 g

Two consecutive blood sampling tests at or
below 40 ug/100 g whole blood
Subsequent final medical determination
results in medical finding, determination, or
opinion that the employee no longer has
detected medical condition placing
employee at risk or material impairment to
health due to lead exposure.

Final Medical determination

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Employee Information and Training (§ 1910.1025(l))
Training Program (§ 1910.1025(l)(1))
The standard requires each employer who has a workplace in which there is potential exposure
to airborne lead to inform employees of the contents of Appendices A and B of the lead standard.
The employer must institute a training program and ensure the participation of all employees
who are subject to lead exposure at or above the action level or for whom the possibility of skin
or eye irritation exists. Training must be provided prior to initial job assignment for new
employees and must be repeated at least annually thereafter for all covered employees.
The employer is responsible for informing employees of the following: (1) the content of the
lead standard and its appendices; (2) the specific nature of the operations that could result in
exposure to lead above the action level; (3) the purpose, proper selection, fitting, use and
limitations of respirators; (4) the purpose and a description of the medical surveillance program
and the medical removal protection program, including information concerning the adverse
health effects associated with excessive exposure to lead (with particular attention to the adverse
reproductive effects on both males and females); (5) the engineering controls and work practices
associated with the employee's job assignment; (6) the contents of any compliance plan in effect;
and (7) instructions to employees that chelating agents should not be used routinely to remove
lead from their bodies, and should not be used at all except under the direction of a licensed
physician.
Access to Information and Training Materials (§ 1910.1025(l)(2))
As directed by the standard, the employer must provide to OSHA and NIOSH, upon request, all
materials relating to the employee information and training program.
In addition the employer must make readily available to all affected employees a copy of this
standard and its appendices.
Signs (§ 1910.1025(m))
Employers must post warning signs in each work area where the PEL is exceeded. The signs
must state: WARNING, LEAD WORK AREA, POISON, NO SMOKING OR EATING.
Posting warning signs serve to warn employees, who may otherwise not know, that they are
entering a hazardous area. Warning signs also supplement the training which employees receive
under this standard.

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Recordkeeping (§ 1910.1025(n))
Exposure Monitoring Records (§ 1910.1025(n)(1))
The standard requires that the employer establish and maintain an accurate record of all
monitoring required by the standard. The exposure monitoring records must include the
following information: (1) the date(s), number, duration, location, and results of each of the
samples taken, including a description of the sampling procedure used to determine
representative employee exposure where applicable; (2) a description of the sampling and
analytical methods used and evidence of their accuracy; (3) the type of respiratory protective
devices worn, if any; name, social security number, and job classification of the employee
monitored and of all other employees whose exposure the measurement is intended to represent;
and (4) the environmental variables that could affect the measurement of employee exposure.
In accordance with the standard, the employer must maintain these exposure monitoring records
for at least 40 years or for the duration of employment plus 20 years, whichever is longer.
Medical Surveillance Records (§ 1910.1025(n)(2))
The standard requires that the employer establish and maintain an accurate record for each
employee subject to medical surveillance as required by this standard. Medical surveillance
records must include the following information: (1) the name, social security number, and
description of the duties of the employee; (2) a copy of the physician's written opinions;
(3) results of any airborne exposure monitoring done for that employee and the representative
exposure levels supplied to the physician; and (4) any employee medical complaints related to
exposure to lead.
As directed by the standard, the employer must keep, or ensure that the examining physician
keeps, the following medical records: (1) a copy of the medical examination results, including
required medical and work histories; (2) a description of the laboratory procedures and a copy of
any standards or guidelines used to interpret the test results or references to that information; and
(3) a copy of the results of the biological monitoring.
The employer must maintain or ensure that the physician maintains these medical surveillance
records for at least 40 years, or for the duration of employment plus 20 years, whichever is
longer.
Medical Removal Records (§ 1910.1025(n)(3))
The lead standard requires that the employer establish and maintain an accurate record for each
employee removed from current exposure to lead. Each medical removal record must include
the following information: (1) the name and social security number of the employee; (2) the date
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of each occasion on which the employee was removed from current exposure to lead as well as
the corresponding date on which the employee was returned to his or her former job status; (3) a
brief explanation of how each removal was or is being accomplished; and (4) a statement with
respect to each removal, indicating whether or not the reason for the removal was an elevated
blood lead level.
In accordance with the standard, the employer must maintain each medical removal record for at
least the duration of an employee's employment.
Records Access (§ 1910.1025(n)(4))
As directed by the standard, the employer must make all records required to be maintained
available, upon request, to the Assistant Secretary and the Director for examination and copying.
In addition, the employer must make environmental monitoring, medical removal, and medical
surveillance records available, upon request, for examination and copying to employees, their
designated representatives, and the Assistant Secretary, in accordance with OSHA's Access to
Employee Exposure and Medical Records Standard (29 CFR 1910.1020).
Records Transfer (§ 1910.1025(n)(5))
When an employer ceases to do business, the successor employer must receive and retain all
records required to be maintained by the standard for the prescribed period. If there is no
successor, records must be transmitted to NIOSH at the expiration date of the retention period
for the records. The employer must notify NIOSH at least 3- months prior to the disposal of
such records and must transmit these records to the Director if requested within the period. The
employer must also comply with any additional requirements involving the transfer of records
set forth in 29 CFR 1910.1020(h).
3. Describe whether, and to what extent, the collection of information involves the use of automated,
electronic, mechanical, 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 when establishing and maintaining
exposure-monitoring and medical-surveillance records. OSHA wrote the paperwork
requirements of the standard in performance-oriented language (i.e., in terms of what data to
maintain, not how to maintain the data).
4. Describe efforts to identify duplication. Show specifically why any similar information already available
cannot be use 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.
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5. If the collection of information impacts small business or other entities (Item 5 of OMB Form 83-I),
describe any methods used to minimize burden.

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

OSHA's recordkeeping requirements are designed to ensure that employers are complying with
applicable standards and that protection of employees exposed to lead is provided to the full
extent required. Occupational safety and health compliance officers examine the records for this
purpose when conducting inspections. Additionally, the data contained in exposure
measurement records are useful to employers in pinpointing areas of their operations that may
require additional efforts to reduce exposure.
Records of previous medical examinations are used by physicians who must periodically
examine employees exposed to lead. Without records of previous medical examinations, the
physician may not be able to determine whether an employee has suffered an adverse health
effect 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 condition to make an
accurate diagnosis of the new problem, its apparent cause, and the course of treatment required.
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 or exposed to lead.
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
that 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
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-

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.

Paragraph (d)(8)) requires employers to notify employees of their exposure monitoring results,
individually, in writing or by posting, within 15 working days after the employer's receipt of the
results. Also paragraph (j)(2)(iv) requires employers to notify employees of their biological
monitoring results within five working days after the employers' receipt of the results.
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, 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 specific situations.
These circumstances should be explained.

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)), OSHA
published a Federal Register notice on May 18, 2009 (74 FR 23209, Docket No. OSHA-20090009) requesting public comment on its extension of the information collection requirements
contained in the Standard on Lead in General Industry (29 CFR 1910.1025). This notice was
part of a preclearance consultation program intended to provide those interested parties the
opportunity to comment on OSHA’s request for an extension by the Office of Management and
Budget (OMB) of a previous approval of the information collection requirements found in the
above standard. The Agency did not receive any comments regarding the proposed information
collection request.
9. Explain any decision to provide any payment or gift to respondents, other than remuneration 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 of the assurance in
statute, regulation, or agency policy.

Since medical records contain information that may be considered private, OSHA has taken
steps to ensure that the 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

13

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.

There are no provisions in this standard requiring that questions of a sensitive nature be asked;
therefore, this question is not applicable to this clearance request.
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 burden for collections of
information, identifying and using appropriate wage rate categories.

This memorandum provides updates to the Burden-Hour and Cost Determinations section of the
Information-Collection Requirement of the Lead in General Industry (29 CFR 1910.1025). Specifically
addressed are estimates of the number of establishments and exposed employees covered by the Standard.
These estimates have been revised to reflect the most recent available data yet have retained the original
formulas for estimation from the previous ICR. The following excerpts are from the Lead in General
Industry ICR and reflect updated figures from the U.S. Census Bureau, the Bureau of Labor Statistics and
other sources cited below.
BURDEN HOUR AND COST DETERMINATIONS
Wage Rates
The following hourly wage rates for the relevant occupational categories have been derived from the May
2007 National Industry-Specific Occupational Employment and Wage Estimates published by the Bureau
of Labor Statistics. These wages have been adjusted to reflect the fact that fringe benefits comprise
roughly 29.3 percent of total employee compensation in the private sector. The costs of labor used in this
analysis are therefore estimates of total hourly compensation. These hourly wages are:
•
•
•

Employee
Clerical/Secretary
Professional/Manager

$31.27
$21.18
$47.13

14

Table 1
Summary of Burden Hours and Costs for the
Collections of Information contained in the
Lead in General Industry Standard
Information Collection
Requirement

Current
Burden Hours

Proposed
Burden Hours

Program
Change

Estimated Cost

191,404

185,273

-6,131

$5,793,487

9,977

9,825

-152

$208,094

COMPLIANCE PROGRAM

0

0

0

$0

ADMINISTRATIVE CONTROLS

1

1

0

$47

RESPIRATOR PROGRAM

0

0

0

$0

NOTIFY THE LAUNDRY

0

0

0

$0

Biological Monitoring

338,018

327,193

-10,825

$10,231,325

Employee Notification

64,862

62,785

-2,077

$1,329,786

Medical Examinations

498,543

482,576

-15,967

$15,051,507

Information to the Physician

19,783

19,150

-633

$405,597

Physician's Opinion

19,783

19,150

-633

$405,597

1

1

0

$21

Training Program

19,284

18,669

-615

$879,870

Access to Training Materials

4,989

4,912

-77

$104,036

Exposure Records

7,656

29,644

21,988

$627,860

Medical Records

65,077

62,993

-2,084

$1,334,192

Removal Records

92

89

-3

$1,885

EXPOSURE MONITORING
Periodic Exposure
Measurement
Employee Notification of
Monitoring Results

MEDICAL SURVEILLANCE

Chelation Notification
EMPLOYEE INFORMATION
AND TRAINING

RECORDKEEPING

15

Access to Records

3,090

2,992

-98

$64,098

Transfer of Records

2

2

0

$42

1,242,562

1,225,255

-17,307

$36,437,444

TOTAL

Exposure Monitoring (§ 1910.1025 (d))
The cost of exposure monitoring is based on the cost per sample and the number of samples that must be
taken. Also, employers would have in-house industrial hygiene technicians take the samples and send
them to a lab to be analyzed.
Initial Exposure Measurement

Employers must determine if any employees are exposed to lead at or above the action level. As
evidenced in Table A, we have identified no new facilities since the last ICR was prepared;
therefore, there are 0 burden hours and costs for initial monitoring.
Periodic Exposure Measurement
Based on the initial monitoring results, periodic monitoring is required every six months if employees are
exposed above the action level but below the PEL, and quarterly if employees are exposed to lead above
the PEL. For purposes of estimating burden hours and costs in this Information Collection Request (ICR),
no employers are exposing their employees to lead levels above the PEL, and therefore, there are no
burden hours and costs for quarterly monitoring.
OSHA estimates 370,546 employees may be exposed to lead at levels between the action level and the
PEL, requiring employers to conduct periodic monitoring at six-month intervals. Approximately one in
four employees is actually sampled. One technician takes eight samples per day, thus OSHA assumes it
takes one hour of a technician’s time to sample and document results. Hours involved in periodic
exposure monitoring are estimated as follows:
Burden hours: (370,546÷ 4) × 1 hour × 2 samples/year = 185,273 hours
Costs:
185,273 hours × $31.27 = $5,793,487
Periodic monitoring is also required whenever there is a production, process, control, or personnel change
that may result in new or additional exposures to lead. OSHA has not included any burden estimate for
such additional monitoring since it is likely that the estimates given for periodic monitoring above are too
high because they do not take into consideration whether employers have reduced some employee
exposures to below the action level since 1978, so that they could discontinue periodic monitoring. The
hours estimated above represent total periodic and additional monitoring burdens.
Employee Notification of Monitoring Results
The standard requires that employers notify employees of monitoring results, individually in writing or by
posting the results, within 15 working days of the employer's receipt of the results. A clerk takes 5

16

minutes (.08 hour) to notify employees of their exposure-monitoring results. OSHA assumes 61,405
employers conduct periodic semiannual monitoring, taking 5 minutes (.08 hour) to post the results.
Burden hours: (61,405 employers) × 2 (semiannual)) × .08 hour = 9,825 hours
Costs:
9,825 hours × $21.18 = $208,094
Written Compliance Program (§ 1910.1025 (e))
The standard requires that each employer establish and implement a written compliance program to
reduce employee exposures to or below the PEL (and interim levels, if applicable) solely by means of
engineering and work practice controls. Such plans must be revised and updated annually to reflect the
current status of the program until all employee exposures are reduced to or below the PEL solely by
engineering and work practice control methods. The standard required that compliance with this provision
be achieved no later than one year from the standard's effective date (March 1, 1979). Therefore, all firms
that were in existence prior to the date of this clearance request (1987) have already prepared their written
plans. For purposes of this ICR, new firms are assumed to have employee lead exposure levels below the
PEL; therefore, new firms are not required to develop compliance plans. In addition, existing firms that
have successfully reduced employee exposure below the PEL are not required to revise their written
compliance plans.
Administrative Controls (§ 1910.1025 (e)(6))
Although the standard permits the use of employee rotation to control exposure to lead, OSHA assumes
that the establishment and implementation of such job rotation schedules are not widely used because of
the administrative difficulties inherent in such a practice. There may be some operations where such
practice is feasible; however, OSHA has no indication of the number of employers or employees who will
be involved. OSHA has, therefore, included one hour of supervisory time as the burden of this
requirement at a cost of $47.
Respiratory Protection (§ 1910.1025(f)(2))
The standard requires the employer to institute a respiratory protection program in accordance with 29
CFR 1910.134. No burden is taken for this requirement. The burden is taken in the Respiratory protection
paperwork package for §1910.134 (OMB Control Number 1218-0099).
Notifying the Laundry (§ 1910.1025 (g)(vi))
This ICR assumes no employers have employees exposed over the PEL; therefore there are no burden
hours and no costs associated with this provision.
Medical Surveillance (§ 1910.1025 (j))
Employers must institute a medical surveillance program for all employees who are or may be exposed to
lead above the action level for more than 30 days each year. OSHA estimates that 35,797 employees in
the five major industrial sectors are exposed to levels of lead above the action level for more than 30 days
per year and 334,749 employees in the miscellaneous industry sectors are assumed to be exposed at this
level.

17

Biological Monitoring
The employer must make available biological monitoring in the form of blood sampling and analysis for
lead and zinc protoporphyrin (ZPP) levels to each employee who may be exposed to lead above the action
level for more than 30 days per year. Such monitoring must be made available at least every six months.
OSHA assumes that all of the 370,546 employees exposed above the action level in existing industries
(see Table A) require such monitoring. OSHA has estimated that blood sampling requires approximately
15 minutes (.25 hour) of the employee's time and of the occupational health nurse's time.
Burden hours: 370,546 employees × 2 samples per year × .25 hours = 185,273 hours
Costs:
185,273 hours × $31.27 = $5,793,487
The standard requires blood sampling and analysis every two months for employees found to have blood
lead levels at or above 40 µg/100 g and at least monthly for employees who are removed from exposure
to lead due to elevated blood lead levels (in excess of 50 µg/100 g). According to information gathered by
OSHA during the rulemaking process for lead, even achievement of the PEL of 50 µg/m3 will not result
in maintaining the blood lead levels of all occupationally exposed workers below 40 µg/100 g. Even in
those industries achieving compliance with the PEL, OSHA predicts that 0.5 percent of worker blood
leads will exceed 60 µg/100 g; 5.5 percent will have blood leads between 50-60 µg/100 g; and 23.3
percent will be between 40-50 µg/100 g. Overall, 29.3 percent of exposed workers will have blood lead
levels above 40 µg/100 g at any one time.
With the above estimates in mind, OSHA estimates 6 percent (or 22,233 employees) of the 370,546
employees may have blood lead levels which would require removal from further lead exposure and
monthly biological monitoring. Since two months of sampling have been accounted for under the
biological monitoring estimates discussed above, only 10 additional blood samples must be taken for
these employees.
Burden hours: 22,233 employees × 10 samples × .25 hour = 55,583 hours
Costs:
55,583 employee hours × $31.27 = $1,738,080
Approximately 23.3 percent (or 86,337) of the 370,546 employees employed in those industries may have
blood lead levels which would require biological monitoring every two months. Since OSHA has already
accounted for two months of such monitoring above, only 4 additional blood samples must be taken for
these employees:
Burden hours: 86,337 employees × 4 samples × .25 hour = 86,337 hours
Costs:
86,337 × $31.27 = $2,699,758
Employee Notification of Biological Monitoring Results
The lead standard requires that the employer notify, in writing, within 5 working days after the receipt of
biological monitoring results, each employee whose blood lead level exceeds 40 µg/100 g of whole
blood. On the basis of OSHA's estimates, 108,570 of the 370,546 employees assumed to be exposed at
levels above 40 µg/100g of whole blood, will require notification of biological monitoring results.

18

Based on the above information, OSHA estimates 22,233 employees require monthly notification and
approximately 86,337 employees require bi-monthly notifications. Such notification takes five minutes
(.08 hour) of secretarial time ($21.18 per hour). Total burden hours of this requirement are shown below.
Burden hours: (22,233 × 12 notifications × .08 hour) + (86,337 × 6 notifications × .08 hour) =
62,785 hours
Costs:
62,785 hours × $21.18 = $1,329,786
Medical Examinations and Consultations
The lead standard requires that employers make medical examinations and consultations available to each
employee who may be exposed above the action level for more than 30 days per year. Such examinations
and consultations must be provided annually for each employee for whom a blood sampling test
conducted at any time during the preceding 12 months indicates a blood lead level at or above 40 µg/100
g of whole blood. OSHA assumes that 29.3 percent (or 108,570 employees) will experience blood levels
at or above 40 µg/100 g, thus, requiring medical examination. Medical examinations are assumed to
require 2 hours of employee time which includes time away from their work station.
Burden hours: 108,570 exams × 2 hours employee time = 217,140 hours
Costs:
217,140 employee hours × $31.27 = $6,789,968
OSHA estimates an employee turn-over rate of approximately 30 percent, therefore 111,164 employees in
the existing lead-using/producing industries will require an initial medical examination.
Burden hours: 111,164 exams × 2 hours employee time = 222,328 hours
Costs:
222,328 employee hours × $31.27 = $6,952,197
In accordance with the lead standard, each employer must also make medical examinations available to
those employees who have developed signs or symptoms commonly associated with lead intoxication, to
those employees who desire medical advice concerning the effects of current or past exposures to lead on
the employee's ability to produce healthy children or to those employees who demonstrate difficulty in
breathing during respirator fit testing or during respirator use. OSHA estimates that no more than 5
percent (or 18,527) of employees exposed above the action level in each industrial sector will receive
medical examinations as a result of these specified circumstances.
Burden hours: 18,527 exams × 2 hours employee time = 37,054 hours
Costs:
37,054 employee hours × $31.27 = $1,158,679
In accordance with the lead standard, each employer must provide a medical examination as medically
appropriate for each employee either removed from exposure to lead due to a risk of sustaining material
impairment to health, or otherwise limited pursuant to a final medical determination. Based on the
information collected during the rulemaking proceedings for this standard, OSHA has estimated that
approximately 22,233 employees may require some additional medical examinations as a result of their
being removed from lead exposure because of their high blood lead levels. OSHA has estimated that
approximately five percent (or 1,112) of these employees may require additional medical examinations.
Burden hours: 1,112 exams × 2 hours employee time = 2,224 hours
Costs:
2,224 employee hours × $31.27 = $69,544
19

Multiple Physician Review Mechanism
The lead standard requires that each employer promptly notify each employee of his or her right to seek a
second medical opinion after each occasion during which a physician conducts a medical examination or
consultation. This requirement can be fulfilled by including a photocopy of such notification with the
physician's written medical opinion that the employer must provide to each employee after each medical
examination. OSHA estimates that inclusion of this notification form will require no more than 1 minute
(.016 hour) of clerical time. According to the estimates made above, employers will provide
approximately 239,373 medical examinations each year which will require the insertion of this
notification in each employee's medical opinion.
Burden hours: 239,373 exams × .016 hour = 3,830 hours
Costs:
3,830 hours × $21.18 = $81,119
Information Provided to Examining and Consulting Physicians
Information must be provided to physicians who will conduct medical examinations of employees under
the requirements of the lead standard. A clerical employee takes 5 minutes (.08 hour) to provide the
required information to physicians. Based on the analysis above there are 239,373 examinations to be
performed annually.
Burden hours: 239,373 exams × .08 hours = 19,150 hours
Costs:
19,150 hours × $21.18 = $405,597
Physician's Written Opinion
OSHA estimates five minutes (.08 hour) of clerical time is needed to give each examined employee a
copy of the physician's written opinion.
Burden hours: 239,373 exams × .08 hour = 19,150 hours
Costs:
19,150 hours × $21.18 = $405,597
Chelation Notification
In accordance with the lead standard, each employer must notify each employee in writing prior to
therapeutic or diagnostic chelation. OSHA has prohibited the use of prophylactic chelation and permits
diagnostic and therapeutic only under the supervision of a licensed physician with appropriate medical
monitoring in an acceptable clinical setting. In general, chelation is only performed in severe cases of lead
intoxication. Unless severe symptoms are present, therapeutic chelation is not recommended given the
opportunity to remove a worker from exposure and to allow the body to naturally excrete accumulated
lead. For this reason, OSHA does not anticipate much use of chelation and, consequently, does not
foresee the need for large scale notification of employees. Therefore, we have estimated that one hour of
secretarial time at a cost of $21.18 ($21 rounded).
Employee Information and Training (§ 1910.1025 (l))
Training Program
20

As the lead standard contains the majority of the information employers must include in their training
programs, OSHA has estimated that preparation of the training program should entail no more than eight
hours of an employer's time. Since there is no requirement to annually review and update training
program, there are no burden hours and costs for reviewing and updating.
The employer is required to inform all employees potentially exposed to lead, at any level, of the contents
of Appendices A and B of the Standard. Such information is part of the training to be given to all
employees exposed above the action level; OSHA assumes that only those new employees who will be
exposed to levels below the action level will need to be given this information outside of the normal
training program. OSHA estimates that this requirement takes no more than 15 minutes (.25 hour) of a
supervisor's time ($47.13 per hour) for the estimated 11,382 new employees entering the covered
industries each year not exposed above the action level. OSHA estimates that employers can present this
information to groups of approximately 20 employees.
Burden hours: 11,382 employees ÷ 20 per session × .25 hour = 142 hours
Costs:
142 hours × $47.13 = $6,692
The more extensive training requirements are required to be presented annually for the 370,546
employees exposed above the action level. OSHA estimates that it takes one hour of supervisory time for
each group of 20 employees.
Burden hours: 370,546 employees ÷ 20 × 1 hour = 18,527 hours
Costs:
18,527 hours × $47.13 = $873,178
Access to Training Materials
OSHA estimates that making a copy of the lead standard, its appendices, and additional information
provided to the employer by the Secretary of Labor, available to all affected employees by simply posting
the materials or a notice of their location on an employee bulletin board will require no more than five
minutes (.08 hour) of secretarial time on an annual basis.
Burden hours: 61,405 employers × .08 hour = 4,912
Costs:
4,912 hours × $21.18 = $104,036
Recordkeeping
Exposure Monitoring Records
OSHA estimates that employers take 5 minutes (.08 hour) to update and maintain each employee’s
exposure monitoring record annually, and that a secretary fulfills this requirement. The number of
workers exposed who must be monitored periodically in existing facilities totals 370,546.
Burden hours: 370,546 × .08 hour = 29,644 hours
Costs:
29,644 hours × $21.18 = $627,860
Medical Surveillance Records

21

OSHA estimates employers take 10 minutes (.17 hour) to establish, update, and maintain employee
medical surveillance records. The number of records to be created and maintained in each industrial
sector is based on the number of workers exposed who must be provided medical examinations due to
their occupational exposure to lead.
Burden hours: 370,546 employees × .17 hour = 62,993 hours
Costs:
62,993 hours × $21.18 = $1,334,192
Medical Removal Records
Approximately five percent of the 22,233 employees are removed from lead exposure as a result of their
being found to have blood lead levels in excess of 50 µg / 100 g. OSHA estimates that approximately 5
minutes (.08 hour) will be required to establish and maintain medical removal records.
Burden hours: 22,233 records × 5% × .08 hour = 89 hours
Costs:
89 hours × $21.18 = $1,885
Employee Access
OSHA has no information that permits any confident determination of the number of employees who will
request access to their exposure monitoring, medical, and/or medical removal records each year. OSHA
therefore assumes that approximately 10 percent of employees exposed to lead over the action level will
annually request access to these records. Providing access will require approximately 5 minutes (.08 hour)
per request.
Burden hours: 370,546 employees × 10% × .08 hour = 2,964 hours
Costs:
2,964 hours × $21.18 = $62,778
Federal Access
The employer must provide, upon request, compliance plans, exposure monitoring, medical surveillance,
and employee training and information program to the Assistant Secretary and the Director. Normally
such requests would occur only in the context of a compliance inspection. Based upon the previous
number of inspections in which citations occurred, there have been 345 inspections where OSHA could
have requested access to exposure monitoring, medical surveillance, and training materials. Providing
access to such materials should require no more than 5 minutes of supervisor time ($47.13).
Burden hours: 345 inspections × .08 hour = 28 hours
Costs:
28 hours × $47.13 = $1,320
Transfer of Records to NIOSH
Based on previous ICRs, NIOSH may receive 156 employee records from 2 employers. A secretary
earning $21.18 per hour takes 1 hour preparing and sending records to NIOSH. Therefore, the burden and
cost is as follows:
Burden hours: 2 employers × 1 hour = 2 hours
Costs:
2 hours × $21.18 = $42
22

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, 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
The agency assumes that employers will incur costs for analyzing the samples taken for exposure
monitoring. The Agency assumes that it will cost $25 per sample, including supplies used and analysis of
the sample taken. The costs are as follows:
Costs:

185,273 samples × $25 per sample = $4,631,825

Biological Monitoring
The Agency assumes that the cost for a blood lead and ZPP is $65.37.3 The total number of biological
monitoring tests, as described under “Biological Monitoring” section is 1,308,770 samples ((370,546 × 2)
+ (22,233 × 10) + (86,337× 4)). Therefore the cost is $85,554,295.
Medical Examinations

3

The previous ICR update estimated that the cost of a blood lead and ZPP was $61.50 per test. The Consumer Price
Index (CPI) indicated a 6.3% increase in the price of professional medical services from 2005 to 2007; given the
6.3% increase in the price of professional medical services, it was assumed that the cost of laboratory services
increased by 6.3% as well.

23

The total number of medical examinations is 239,373 (see “Medical Surveillance” item 12). The Agency
estimates the cost of a medical examination to be $223.4 Therefore, the total cost for medical
examinations is $53,380,179.
Cost Summary for Monitoring and Examinations
Provision

Cost

Exposure Monitoring

$4,631,825

Biological Monitoring

$85,554,295

Medical Examinations

$53,380,179

Total

$143,566,299

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.

Federal Inspections
OSHA estimates that a compliance officer earning $39.70 per hour takes 10 minutes to review the
records.5 Therefore, the cost to the Federal Government related to inspections is as follows:
Costs:

345 inspections × $39.70 × .17 hour = $2,328

Transfer of Records to NIOSH
In the past, NIOSH received 156 employee records from 2 employers. It will cost $4.50 per record to
process the records. The total cost for processing these records is as follows:
Costs:

156 employee records × $4.50 per record = $702

4

The previous ICR estimated that the cost of a medical examination was $210.00; given the 6.3% increase in the
price of professional medical services as discussed previously, it was assumed that the cost of a medical
examination increased by 6.3% as well.
5
This rate represents the average 2008 General Schedule (GS) hourly wage rate for a compliance officer (GS-12,
Step 5) in each of the 32 geographic regions as specified by the U.S. Office of Personnel Management.

24

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

The Agency is requesting a -17,307 hour decrease, from 1,242,562 hours to 1,225,255 hours. The
decrease is primarily due to the reduction in the number of facilities (from 62,357 to 61,405) and
exposed employees (from 887,113 to 871,974). Additionally, although there is a reduction in the
number of facilities and exposed employees as stated above, the cost estimate to perform medical
surveillance has increased from $61.50 to $65.37 and medical examinations increased from $210 to
$223 resulting in a cost increase of $3,697,299.
16. For collections of information whose results will be published, outline plans for tabulation, and publication.
Address any complex analytical technique that will be used. Provide the time schedule for the entire project,
including beginning and ending dates of the collection of information, completion of report, publication dates, and
other actions.

This question is not applicable as this information to be collected will not 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 inappropriate.

There are no forms on which to display the expiration date.
18. Explain each exception to the certification statement in 83-I.
OSHA is not requesting an exception to the certification statement in ROCIS.

25

Table A. Estimated Number of Facilities and Exposed Employees
2005 Estimates

New Estimates

Estimated
# Facilities

Estimated
# Exposed
Employees

Estimated #
Employees
Exposed Above
the Action
Level, but
Below the PEL

Primary Smelting

12

3,497

3,112

1iii

291

259

Secondary Smelting

35

3,286

1,595

21iv

1,974

958

Battery Manufacture

110

14,803

9,770

98v

13,230

8,732

Industrial Sector

Estimated
# Facilities

Estimated
# of
Exposed
Employeesi

Estimated #
Employees
Exposed Above
the Action Level,
but Below the
PELii

vi

Nonferrous Foundries

345

14,818

8,298

327

14,045

7,865

Lead Pigment
Manufacture

84

3,099

2,634

9vii

332

282

Additional 5 Sector
Estimates from 1987
ICR

23

1,580

964

23viii

1,580

964

Miscellaneous Sectors

58,025

794,797

334,749

58,025viii

794,797

334,749

Additional
Miscellaneous Sector
Estimates from 1987
ICR

2,901

45,725

16,737

2,901viii

45,725

16,737

Total

61,535

875,605

377,859

61,405

871,974

370,546

26

i

The ratio of estimated number of exposed employees to the estimated number of facilities has been retained from the
previous ICR update. Values presented in this column reflect this original ratio and updated facility data.
ii
The ratio of estimated number of employees exposed above the action level, but below the permissible exposure limit
has been retained from the previous ICR update.
iii
Source: U.S. Geological Survey (USGS), Mineral Commodity Summaries, January 2008. The USGS reports that
primary lead was processed at one smelter-refinery in Missouri in 2007.
iv
Source: USGS, 2008. The USGS reports that there were 21 plants producing secondary lead in the United States in
2007.
v
Source: USGS, 2008. The USGS reports that there were approximately 110 manufacturing plants consuming lead in the
U.S. and that the lead-acid battery industry accounted for approximately 89 percent of the reported domestic lead
consumption in 2007. The Agency assumed that 89 percent of these manufacturing facilities were in the lead-acid
battery industry.
vi
The total number of establishments in NAICS 331522 (Nonferrous (except Aluminum) Die-Casting Foundries) and
NAICS 331528 (Other Nonferrous Foundries (except Die-Casting)) in 2005 was 338 with total employment of 17,362.
This represents a 5.3% and 9.3% decrease in the number of establishments and employees, respectively, from 2003 data.
The Agency assumed that the number of facilities and employees covered by the Standard decreased by this percentage
as well.
vii
Source: USGS, 2008 and U.S. Census Bureau, 2002 Economic Census: NAICS 325131 – Inorganic dye and pigment
manufacturing. According to the U.S. Census Bureau, there were 81 total establishments in the Inorganic dye and
pigment manufacturing industry in 2002. The Agency is unable to locate data regarding the number of firms
manufacturing lead-containing pigment (or the extent to which this pigment is used today, if at all), however, assumes
that manufacturing and use have declined significantly in recent years given government regulation and public health
concerns. The USGS reported that in 2007 about 8 percent of lead was used in ammunition; casting material; sheets
(including radiation shielding), pipes, traps and extruded products; cable covering, caulking lead, and building
construction; solder; and oxides for glass, ceramics, pigments, and chemicals. Conservatively, if all eight percent of lead
used in these industries was used in lead oxide pigment manufacturing, The Agency estimates that this industry would
be comprised of 9 firms (8 percent of 110).
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Based on available documentation, the Agency was unable to determine from which industries and/or occupations
these estimates were derived; the Agency was unable to locate neither the 1987 ICR nor the original RIA. Because total
consumption of lead as reported by the USGS has not changed significantly since publication of the previous ICR, the
Agency is retaining these estimates.

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