Hclss_1218-0131(06-23-08)

SUPPORTING STATEMENT FOR THE
INFORMATION COLLECTION REQUIREMENTS OF THE
STANDARD ENTITLED “OCCUPATIONAL EXPOSURE TO
HAZARDOUS CHEMICALS IN LABORATORIES” (29 CFR 1910.1450) 1
(OMB CONTROL NO. 1218-0131 (June 2008))

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 purpose of the Occupational Safety and Health Act (“OSH Act” or “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 standards" (29 U.S.C. 651). The 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).
To protect employee health, the OSH Act authorizes the Occupational Safety and Health
Administration (“OSHA” or “Agency”) 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 . . . to most effectively determine whether the health of such
employees is adversely affected by such exposure” (29 U.S.C. 655). Moreover, the Act directs
OSHA to “issue 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 . . . " (29 U.S.C. 657). 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 [the employer’s] activities relating to this Act as the Secretary . . . may
prescribe by regulation as necessary or appropriate for the enforcement of this Act . . . ” (29
U.S.C. 657).
The Act authorizes the Agency to issue standards that “prescribe use of labels or other
appropriate forms of warning as are necessary to insure that employees are apprised of all
hazards to which they are exposed, relevant symptoms and appropriate emergency treatment, and
proper conditions and precautions of safe use or exposure” (29 U.S.C. 655). Additionally, the
OSH Act mandates that “[e]ach employer shall make, keep and preserve, and make available to

1

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

the Secretary . . . such records . . . as the Secretary . . . may prescribe by regulation as necessary
or appropriate for the enforcement of this Act . . . ” (29 U.S.C. 657).
Beginning in the early 1970s, OSHA published numerous health standards to control employee
exposure to toxic substances in 29 CFR part 1910, subpart Z (the “subpart Z standards”). 2
However, OSHA developed the subpart Z standards primarily to protect employees exposed to
toxic substances during industrial operations. These operations typically involve exposure to a
few toxic substances emitted during a standardized and continuous or repetitive process that uses
large quantities of the toxic substances. In laboratories, employees use small quantities of
numerous hazardous chemicals 3 in a variety of analytic and clinical procedures and operations,
each of which they perform infrequently or periodically. In addition, standard laboratory
practices often require techniques that control the release of, and exposure to, hazardous
chemicals (e.g., extensive labeling, sealed containers, protective clothing, fume hoods). 4
Moreover, laboratory employees have better knowledge of the hazardous chemicals with which
they work than do employees involved in typical industrial operations; based on the high level of
training they receive, laboratory employees usually have a thorough understanding of the
chemical properties of these substances, as well as the safety and health problems associated
with them.
Based on this evidence, OSHA concluded that, in general, laboratory employees have minimal
exposures to hazardous chemicals in the workplace (i.e., below the action level (i.e., “AL”) or, in
the absence of an AL, the permissible exposure limit (“PEL”) specified by subpart Z for any of
these substances). Therefore, under the authority granted by the OSH Act, the Agency published
a health standard governing occupational exposure to hazardous chemicals in laboratories (29
CFR 1910.1450; the “Standard”).
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.

The Standard contains a number of paperwork requirements. The following paragraphs describe
these requirements, specify who uses them, and what purpose they serve.

2

Employers also have an obligation to protect employees from exposure to toxic substances under the generalduty clause of the Act at 29 U.S.C. 654.
3

For the purposes of this Supporting Statement, the term “hazardous chemical” means a chemical for which acute
or chronic health effects may occur in exposed employees as demonstrated by statistically significant evidence based
upon at least one study conducted in accordance with established scientific principles. (See paragraph (b) of
§ 1910.1450).
4

Employers institute these practices not only to protect their employees from exposure to the toxic substances, but
also to ensure the reliability of the analytic or clinical results.

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A. Employee exposure determination (§1910.1450(d))
Initial monitoring (§1910.1450(d)(1))
The employer shall measure the employee's exposure to any substance regulated by a standard
which requires monitoring if there is reason to believe that exposure levels for that substance
routinely exceed the action level (or in the absence of an action level, the PEL).
Purpose: Initial monitoring assists employers in identifying procedures and operations that
require modification to reduce exposures to the AL or PEL specified by the appropriate subpart
Z standard. In this regard, initial monitoring results enable employers to determine the need for
engineering controls, institute new (or modify existing) work practices, and select appropriate
respiratory protection to prevent employee overexposure. This information also determines
whether or not the employer must perform periodic monitoring.
Periodic monitoring (§1910.1450(d)(2))
§1910.1450(d)(2) - If the initial monitoring prescribed by paragraph (d)(1) of this section
discloses employee exposure over the action level (or in the absence of an action level, the PEL),
the employer shall immediately comply with the exposure monitoring provisions of the relevant
standard.
Purpose: Employers use periodic monitoring results to evaluate the effectiveness of selected
control methods. In addition, these measurements remind both the employer and employees of
the need to protect employees against the effects of overexposure to hazardous chemicals in
laboratory facilities. These monitoring data will also inform the examining physician of the
existence and extent of an employee’s exposure to the hazardous chemical(s) for use in assessing
the employee’s medical condition.
Termination of monitoring (§1910.1450(d)(3))
Monitoring may be terminated in accordance with the relevant standard.
Employee notification of monitoring results (§1910.1450(d)(4))
The employer shall, within 15 working days after the receipt of any monitoring results, notify the
employee of these results in writing either individually or by posting the results in an appropriate
location that is accessible to employees.
Purpose: Notification provides employees with information they can use to assess the
effectiveness of the controls their employer implement to reduce their exposures to hazardous
laboratory chemicals, and to determine if any medical signs and symptoms they may be
experiencing could be the result of their exposure to these chemicals.
B. Chemical Hygiene Plan (CHP) (§1910.1450(e))
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§1910.1450(e)(1) - Where hazardous chemicals as defined by this standard are used in the
workplace, the employer shall develop and carry out the provisions of a written Chemical
Hygiene Plan which is:
§1910.1450(e)(1)(i) - Capable of protecting employees from health hazards associated with
hazardous chemicals in that laboratory, and
§1910.1450(e)(1)(ii) - Capable of keeping exposures below the limits specified in paragraph (c)
of this section.
§1910.1450(e)(3) - The Chemical Hygiene Plan shall include each of the following elements and
shall indicate specific measures that the employer will take to ensure laboratory employee
protection:
§1910.1450(e)(3)(i) - Standard operating procedures relevant to safety and health considerations
to be followed when laboratory work involves the use of hazardous chemicals;
§1910.1450(e)(3)(ii) - Criteria that the employer will use 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;
§1910.1450(e)(3)(iii) - A requirement that fume hoods and other protective equipment are
functioning properly and specific measures that shall be taken to ensure proper and adequate
performance of such equipment;
§1910.1450(e)(3)(iv) - Provisions for employee information and training as prescribed in
paragraph (f) of this section;
§1910.1450(e)(3)(v) - The circumstances under which a particular laboratory operation,
procedure or activity shall require prior approval from the employer or the employer's designee
before implementation;
§1910.1450(e)(3)(vi) - Provisions for medical consultation and medical examinations in
accordance with paragraph (g) of this section;
§1910.1450(e)(3)(vii) - Designation of personnel responsible for implementation of the Chemical
Hygiene Plan including the assignment of a Chemical Hygiene Officer, and, if appropriate,
establishment of a Chemical Hygiene Committee; and
§1910.1450(e)(3)(viii) - Provisions for additional employee protection for work with particularly
hazardous substances. These include "select carcinogens," reproductive toxins and substances
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which have a high degree of acute toxicity. Specific consideration shall be given to the following
provisions which shall be included where appropriate:
§1910.1450(e)(3)(viii)(A) - Establishment of a designated area;
§1910.1450(e)(3)(viii)(B) - Use of containment devices such as fume hoods or
glove boxes;
§1910.1450(e)(3)(viii)(C) - Procedures for safe removal of contaminated waste;
and
§1910.1450(e)(3)(viii)(D) - Decontamination procedures.
§1910.1450(e)(4) - The employer shall review and evaluate the effectiveness of the Chemical
Hygiene Plan at least annually and update it as necessary.
Purpose: This requirement commits employers to evaluate employee exposures to hazardous
laboratory chemicals and establish an organized and complete program for reducing these
exposures to the PEL specified for these chemicals. The requirement to review and update the
CHP ensures that employers continue to evaluate workplace conditions, including hazardouschemical exposures, and to implement the controls required to reduce employee overexposures.
Employers are required to develop a written Chemical Hygiene Plan and ensure that they carry
out the provisions.
C. Employee Information and Training (§1910.1450(f))
§1910.1450(f)(1) - The employer shall provide employees with information and training to
ensure that they are apprised of the hazards of chemicals present in their work area.
§1910.1450(f)(2) - Such information shall be provided at the time of an employee's initial
assignment to a work area where hazardous chemicals are present and prior to assignments
involving new exposure situations. The frequency of refresher information and training shall be
determined by the employer.
§1910.1450(f)(3) - Employees shall be informed of:
§1910.1450(f)(3)(i) - The contents of this standard and its appendices which shall be made
available to them;
§1910.1450(f)(3)(ii) - the location and availability of the employer's Chemical Hygiene Plan;
§1910.1450(f)(3)(iii) - The permissible exposure limits for OSHA regulated substances or
recommended exposure limits for other hazardous chemicals where there is no applicable OSHA
standard;
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§1910.1450(f)(3)(iv) - Signs and symptoms associated with exposures to hazardous chemicals
used in the laboratory; and
§1910.1450(f)(3)(v) - The location and availability of known reference material on the hazards,
safe handling, storage and disposal of hazardous chemicals found in the laboratory including, but
not limited to, Material Safety Data Sheets, (MSDSs) received from the chemical supplier.
Training (§1910.1450(f)(4))
§1910.1450(f)(4)(i) - Employee training shall include:
§1910.1450(f)(4)(i)(A) - Methods and observations that may be used to detect the
presence or release of a hazardous chemical (such as monitoring conducted by the
employer, continuous monitoring devices, visual appearance or odor of hazardous
chemicals when being released, etc.);
§1910.1450(f)(4)(i)(B) - The physical and health hazards of chemicals in the work area; and
§1910.1450(f)(4)(i)(C) - The measures employees can take to protect themselves from
these hazards, including specific procedures the employer has implemented to protect
employees from exposure to hazardous chemicals, such as appropriate work practices,
emergency procedures, and personal protective equipment to be used.
§1910.1450(f)(4)(ii) - The employee shall be trained on the applicable details of the employer's
written Chemical Hygiene Plan.
Purpose: This requirement is essential to inform employees of the health hazards resulting from
hazardous chemical exposure and to provide them with the understanding necessary to minimize
these hazards. Training serves to explain and reinforce the information presented to employees
on signs, labels, and MSDSs; however, this information will be effective only if employees
understand the information and can take the actions necessary to avoid or minimize hazardous
chemical exposure. Training also enables employees to recognize operations and locations
associated with hazardous chemical exposures, thereby permitting them to limit exposure from
these sources.
D. Medical Consultation and Medical Examinations (§1910.1450(g))
General (§1910.1450(g)(1) and (g)(2))
§1910.1450(g)(1) - The employer shall provide all employees who work with hazardous
chemicals an opportunity to receive medical attention, including any follow-up examinations
which the examining physician determines to be necessary, under the following circumstances:

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§1910.1450(g)(1)(i) - Whenever an employee develops signs or symptoms associated with a
hazardous chemical to which the employee may have been exposed in the laboratory, the
employee shall be provided an opportunity to receive an appropriate medical examination.
§1910.1450(g)(1)(ii) - Where exposure monitoring reveals an exposure level routinely above the
action level (or in the absence of an action level, the PEL) for an OSHA regulated substance for
which there are exposure monitoring and medical surveillance requirements, medical
surveillance shall be established for the affected employee as prescribed by the particular
standard.
§1910.1450(g)(1)(iii) - Whenever an event takes place in the work area such as a spill, leak,
explosion or other occurrence resulting in the likelihood of a hazardous exposure, the affected
employee shall be provided an opportunity for a medical consultation. Such consultation shall be
for the purpose of determining the need for a medical examination.
§1910.1450(g)(2) - All medical examinations and consultations shall be performed by or under
the direct supervision of a licensed physician and shall be provided without cost to the employee,
without loss of pay and at a reasonable time and place.
Purpose: The requirements specified by these paragraphs prevent the development of serious
illnesses among employees overexposed or potentially overexposed to hazardous chemicals used
in their work areas.
Information provided to the physician (§1910.1450(g)(3))
The employer shall provide the following information to the physician:
§1910.1450(g)(3)(i) - The identity of the hazardous chemical(s) to which the employee may have
been exposed;
§1910.1450(g)(3)(ii) - A description of the conditions under which the exposure occurred
including quantitative exposure data, if available; and
§1910.1450(g)(3)(iii) - A description of the signs and symptoms of exposure that the employee is
experiencing, if any.
Purpose: The examining physicians are provided this information to assist them in evaluating
the employee's health and fitness for specific job assignments involving hazardous chemical
exposure. The physician also uses this information to determine if an observed health condition
is contributed to occupational exposure to hazardous chemicals in the laboratory work area.

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Physician’s written opinion (§1910.1450(g)(4))
§1910.1450(g)(4)(i) - For examination or consultation required under this standard, the employer
shall obtain a written opinion from the examining physician which shall include the following:
§1910.1450(g)(4)(i)(A) - Any recommendation for further medical follow-up;
§1910.1450(g)(4)(i)(B) - The results of the medical examination and any associated tests;
§1910.1450(g)(4)(i)(C) - Any medical condition which may be revealed in the course of
the examination which may place the employee at increased risk as a result of exposure
to a hazardous workplace; and
§1910.1450(g)(4)(i)(D) - A statement that the employee has been informed by the
physician of the results of the consultation or medical examination and any medical
condition that may require further examination or treatment.
§1910.1450(g)(4)(ii) - The written opinion shall not reveal specific findings of diagnoses
unrelated to occupational exposure.
Purpose: The purpose of requiring the employer to obtain a physician’s written opinion is to
provide the employer with medical information on whether or not the employee has a condition
indicating overexposure to hazardous chemicals. If such a condition exists, the employer can
implement additional controls to prevent overexposure. The information also allows the
employer to plan necessary medical follow-up and treatment. The requirement that the
physician’s opinion be in writing ensures that the information is available for future reference.
Employees are given a copy of the physician’s written opinion to determine the need for
treatments and other interventions. The written opinion allows the physician to make
recommendations to remove the employee from the contaminated area or to make
recommendations for control measures.
E. Hazard Identification (§1910.1450(h))
§1910.1450(h)(1) - With respect to labels and material safety data sheets:
§1910.1450(h)(1)(i) - Employers shall ensure that labels on incoming containers of hazardous
chemicals are not removed or defaced.
§1910.1450(h)(1)(ii) - Employers shall maintain any material safety data sheets that are received
with incoming shipments of hazardous chemicals, and ensure that they are readily accessible to
laboratory employees.

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§1910.1450(h)(2) - The following provisions shall apply to chemical substances developed in the
laboratory:
§1910.1450(h)(2)(i) - If the composition of the chemical substance which is produced
exclusively for the laboratory's use is known, the employer shall determine if it is a hazardous
chemical as defined in paragraph (b) of this section. If the chemical is determined to be
hazardous, the employer shall provide appropriate training as required under paragraph (f) of this
section.
§1910.1450(h)(2)(ii) - If the chemical produced is a byproduct whose composition is not known,
the employer shall assume that the substance is hazardous and shall implement paragraph (e) of
this section.
§1910.1450(h)(2)(iii) - If the chemical substance is produced for another user outside of the
laboratory, the employer shall comply with the Hazard Communication Standard (29 CFR
1910.1200) including the requirements for preparation of material safety data sheets and
labeling.
Purpose: The provision ensures that employees, whether in a laboratory facility or at a
downstream facility, receive adequate notice and, if necessary, other information regarding
chemicals that are hazardous or potentially hazardous.
OSHA believes that this provision protects employees by alerting them to potential hazardous
chemical exposures, thereby allowing them to take appropriate actions to control these
exposures. In addition, this provision supplements the information and training requirements
contained in paragraph (f) of the Standard.
F. Use of Respirators (§1910.1450(i))
Where the use of respirators is necessary to maintain exposure below permissible exposure
limits, 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 of 29 CFR 1910.134.
Purpose: The purpose of this requirement is to ensure that employers and employees select, use,
and maintain appropriate respirators if respirators are necessary to protect employees from
hazardous chemical exposures.
G. Recordkeeping (§1910.1450(j))
§1910.1450(j)(1) - The employer shall establish and maintain for each employee an accurate
record of any measurements taken to monitor employee exposures and any medical consultation
and examinations including tests or written opinions required by this standard.
Purpose: This requirement provides both employers and employees with useful information.
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The information alerts employers to routine overexposures to hazardous chemicals, thereby
enabling them to modify controls or take other actions necessary to reduce these exposures. The
exposure monitoring and medical information contained in these records assists employees and
their physicians in determining the need for, and effectiveness of, medical treatment and other
interventions implemented in response to the employees’ exposure to hazardous chemicals in a
laboratory facility.
§1910.1450(j)(2) - The employer shall assure that such records are kept, transferred, and made
available in accordance with 29 CFR 1910.1020.
Purpose: Employees and their designated representatives may use these records to evaluate
employee medical status over the course of employment, to determine the effectiveness of the
employer’s exposure reduction program, and for other reasons. An OSHA compliance officer
reviews the records to assess the employer’s compliance with the medical and exposure control
provisions of the Standard.
Paragraph (h) of § 1910.1020 requires employers who cease to do business to transfer medical
and exposure-monitoring records to the successor employer, who then must receive and maintain
the records. If no successor employer is available, the employer must: At least three months
before ceasing business, notify current employees who have records of their right to access these
records; and provide the National Institute for Occupational Safety and Health (NIOSH) with
written notice of the impending disposal of these records at least three months prior to such
disposal. NIOSH may use these records for research purposes (e.g., assessing the medical
effects of long-term exposure to hazardous chemicals); in addition, serving as a repository for
medical and exposure monitoring records, it provides employees with continuous access to 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 any available technology to meet the paperwork requirements specified by
the Standard. The Agency wrote these provisions in performance-oriented language, i.e., in
terms of what information to provide, not how to provide it.
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 collection requirements in the Standard are specific to each employer involved,
and no other sources or agencies duplicate these requirements or can make the required
information available to OSHA, i.e., the required information is available only from employers.
5.

If the collection of information impacts small businesses or other small entities (Item 5 of OMB Form

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83-I), describe any methods used to minimize burden.

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

Describe the consequence to Federal program or policy activities if the collection is not conducted or
is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

The Agency believes that the information collection frequencies required by the Standard are the
minimum frequencies necessary to fulfill its mandate “to assure so far as possible every working
man and woman in the Nation safe and healthful working conditions and to preserve our human
resources” as specified in the OSH Act at 29 U.S.C. 651. Accordingly, if employers do not
perform the information collections required by the Standard, or delay in providing this
information, employees are at risk of developing serious illnesses resulting from overexposure to
hazardous chemicals used in laboratory facilities.
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, grantin-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.

Paragraph (d)(4) of the Standard requires that employers 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. Except for this provision, the information collection
requirements of the Standard are consistent with 5 CFR 1320.5.
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8.

If applicable, provide a copy and identify the date and page number of publication in the Federal
Register of the agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information
collection prior to submission to OMB. Summarize public comments received in response to that
notice and describe actions taken by the agency in response to these comments. Specifically address
comments received on cost and hour burden.
Describe efforts to consult with persons outside the agency to obtain their views on the availability of
data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting
format (if any), and on the data elements to be recorded, disclosed, or reported.
Consultation with representatives of those from whom information is to be obtained or those who
must compile records should occur at least once every 3 years, even if the collection-of-information
activity is the same as in prior periods. There may be circumstances that may preclude consultation
in a specific situation. These circumstances should be explained.

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)), OSHA
published a notice in the Federal Register on April 14, 2008 (73 FR 20068, Docket No. OSHA2008-0004) requesting public comment on its proposal to extend the Office of Management and
Budget’s approval of the information collection requirements contained in the Standard on
Hazardous Chemicals in Laboratories (29 CFR §1910.1450). This notice was part of a
preclearance consultation program that provided the general public and government agencies
with an opportunity to comment. The Agency received no comments in response to its notice.
9.

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

The Agency will not provide payments or gifts to the respondents.
10.

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

To ensure that the personal information in the medical records required by the Standard remains
confidential, the Agency developed §1913.10 (“Rules of Agency Practice and Procedure
Concerning OSHA Access to Employee Medical Records’) to regulate its access to these
records.
11.

Provide additional justification for any question of a sensitive nature, such as sexual behavior and
attitudes, religious beliefs, and other matters that are commonly considered private. This
justification should include the reasons why the agency considers the questions necessary, the specific
uses to be made of the information, the explanation to be given to persons from whom the
information is requested, and any steps to be taken to obtain their consent.

The paperwork requirements specified by the Standard do not involve sensitive information.
12.

Provide estimates of the hour burden of the collection of information. The statement should:
· Indicate the number of respondents, frequency of response, annual hour burden, and an
explanation of how the burden was estimated. Unless directed to do so, agencies should not

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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.

Table 1 below presents information for the different types of laboratories covered by the
Standard. For each type of laboratory, the table provides an estimate of the number of facilities
that expose employees to hazardous chemicals and the number of employees so exposed.
Table 1: Number of Laboratory Facilities and Employees for Each Type
of Laboratory
Type of Laboratory

No. of Facilities

No. of
Employees

6,213
13,000
19,213

100,679
1,000,000
1,100,679

7,356
5,179
12,535

166,867
134,547
301,414

2,583
11,060

107,274
41,041

225

110,000

13,868
45,616

258,315
1,660,408

Industrial
Independent testing[a]
Research and development[b]
Subtotals
Clinical
Hospital[c]
Independent-medical[d]
Subtotals
Academic (Private)
Post-secondary[e]
Secondary[f]
Professional and Research
Institutes[g]
Subtotals
Totals
[a]

Source: County Business Patterns 2005. U.S. Department of Commerce, Bureau of the Census. Total
number of Independent Testing Laboratories (ITLs) calculated as the sum of taxable establishments (6,003
establishments, NAICS 54138) and tax-exempt establishments (210 establishments). The number of tax-exempt
establishments estimated as 3.5 percent of total number of ITLs, based on data from 2002 Census. Number of
Employees calculated as the sum of employees in taxable establishments (93,049 employees) and employees in taxexempt establishments (7,630 employees). The number of employees in tax-exempt establishments estimated as 8.2
percent of total number of employees in ITLs, based on data from 2002 Census.

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[b]

Source: Supporting Statement for the Information Collection Requirements of the Standard Entitled
“Occupational Exposure to Hazardous Chemicals in Laboratories” (29 CFR 1910.1450) [ICR 1218-0131 (2005)],
based on analysis by DynCorp I&ET of The Directory of American Research and Technology; Industrial Research
Labs of the United States; and “Survey of Industrial Research and Development,” National Science
Foundation/Division of Science Resources Studies. Because original sources appear to not have been updated,
OSHA has no basis to revise 2005 figures.
[c]

Source: Supporting Statement for the Information Collection Requirements of the Standard Entitled
“Occupational Exposure to Hazardous Chemicals in Laboratories” (29 CFR 1910.1450) [ICR 1218-0131 (2005)] and
Occupational Outlook Handbook, 2008-2009 ed., Bureau of Labor Statistics. Estimate of hospital-based labs derived
by adjusting the 2005 ICR estimate by the percentage increase in lab employees reported in BLS.
[d]

Source: County Business Patterns 2005. U.S. Department of Commerce, Bureau of the Census (NAICS

621511).
[e]

Source: U.S. Department of Education, National Center for Education Statistics, Digest of Education
Statistics, 2006. Table 248: Degree-granting institutions, by control and type of institution. Estimated number of
employees in 2006 based on percentage change in post-secondary labs from 2005 ICR to 2006, applied to estimate
of employees in 2005 ICR.
[f]

Source: U.S. Department of Education, National Center for Education Statistics, Digest of Education
Statistics, 2006. Table 56: Private elementary and secondary enrollment, number of schools, and average tuition, by
school level, orientation, and tuition. Estimated number of employees in 2006 based on percentage change in private
secondary labs from 2005 ICR to 2006, applied to estimate of employees in 2005 ICR.
[g]

Source: 2001 ICR. As OSHA was unable to identify updated establishment and employment figures,
estimates from previous ICR updates have been retained.

Burden Hour and Cost Determinations
The Agency determined average wage rates using average hourly earnings. For the relevant
occupational categories, OSHA adjusted the mean hourly earnings from the National
Compensation Survey, June 2005, Supplementary Tables. U.S. Department of Labor, Bureau of
Labor Statistics, July 2006. Supplementary Table 2.1 to allow for fringe benefits, which
comprise about 29.4% of total compensation in the private sector. With wages comprising
70.6% of employee compensation, the Agency multiplied wages by 1.4 (1/0.706) to derive total
hourly employee compensation. Therefore, the costs of labor used in this analysis are estimates
of total hourly compensation. These estimates are:
Administrative Service Manager:
Employee
Office Clerk

−14−

$41.29
$20.21
$16.95

(A) Employee exposure determination (§1910.1450(d))
Initial monitoring (§1910.1450(d)(1) and periodic monitoring (§1910.1450(d)(2) and (d)(3))
As noted above in Item 1, laboratory employees typically use small quantities of numerous
hazardous chemicals in a variety of procedures and operations, each of which they perform
infrequently or periodically. In addition, standard laboratory practices require techniques that
control the release of, and exposure to, hazardous chemicals (e.g., extensive labeling, sealed
containers, protective clothing such a gloves and goggles, laboratory hoods). Therefore,
overexposure of laboratory employees to hazardous chemicals is rare. Accordingly, OSHA
assumes that only a minimal need exists to conduct initial and periodic exposure monitoring (i.e.,
once a year per laboratory facility), and that a laboratory supervisor takes, on average, 10
minutes (.17 hour) to distribute and collect exposure-monitoring samples and mail them for
analysis. Thus, the estimated burden hours and cost for these requirements each year are:
Burden hours: 45,616 facilities x .17 hour = 7,755 hours
Cost: 7,755 hours x $41.29 = $320,204
Employee notification of monitoring results (§1910.1450(d)(4))
Assuming that employers post exposure monitoring results in an appropriate location, the
Agency estimates that an office clerk spends five minutes (.08 hour) developing and posting
these results for each facility once a year. Therefore, the estimated annual burden hours and cost
of this provision are:
Burden hours: 45,616 facilities x .08 hour = 3,649 hours
Cost: 3,649 hours x $16.95 = $61,851
(B) Chemical hygiene plan (§1910.1450(e))
This paragraph requires new laboratory facilities to develop a chemical hygiene plan (CHP),
while existing facilities must review their CHPs at least annually. 5 The Agency estimates that the
number of laboratory facilities increases by 750 each year, and that a laboratory supervisor
(acting as the Chemical Hygiene Officer) takes 8 hours to develop a new CHP and one-half (.5)
hour to update an existing CHP. The burden hour and cost estimate for this requirement are:
Burden hours: (750 new CHPs x 8 hours) + (45,616 existing CHPs x .5 hours) =
28,808 hours
Costs: 28,808 hours x $41.29 = $1,189,482

5

This paragraph also specifies that employers must, as appropriate, establish designated areas to provide
employees with additional protection. This provision does not require employers to establish records or maintain
information, so the Agency is not taking any burden for this requirement.

−15−

(C) Employee information and training (§1910.1450(f))
The Agency assumes that 20% (332,082) of the employees covered by the Standard require
information and training as specified by this provision; of this 20%, half consist of new or
replacement (turnover) employees who are assuming new assignments, while the remaining half
include existing employees who are receiving new exposures. 6 OSHA estimates that a laboratory
supervisor can deliver the required training to 20 employees in a single session, for a total of
16,604 sessions to train 332,082 employees annually (i.e., 332,082 employees ÷ 20 employees
per session). In addition, the Agency believes that, for each session, the laboratory supervisor
requires 15 minutes (.25 hour) to prepare the training material and 45 minutes (.75 hour) to
deliver it, for a total of one hour. Accordingly, the estimated yearly burden hours and cost of this
information collection requirement are:
Burden hours: 16,604 sessions x 1 hour = 16,604 hours
Cost: 16,604 hours x $41.29 = $685,579
(D) Medical consultation and medical examinations (§1910.1450(g))
General (§1910.1450(g)(1) and (g)(2))
OSHA believes that 8% (132,833) of the employees covered by the Standard receive medical
attention. Of these employees, the Agency assumes that: half (66,417) obtain a medical
consultation, which OSHA estimates takes 45 minutes (.75 hour) to administer; 7 one-fourth
(33,208) receive a medical examination, which the Agency finds takes 1.5 hours to administer;
and the remaining one-fourth get both a medical consultation and medical examination, requiring
an estimated total of 2.25 hours to administer. Thus, the estimated annual burden hour and cost
to employers of the lost productivity resulting from these provisions are:
Burden hours: (66,417 employees x .75 hour) + (33,208 employees x 1.5 hours) +
(33,208 employees x 2.25 hours) = 174,343 hours
Cost: 174,343 hours x $20.21 = $3,523,472
Information provided to the physician (§1910.1450(g)(3))
OSHA estimates that an office clerk spends five minutes (.08 hour) compiling and sending the
required information to the physician prior to each medical consultation or medical examination.
Therefore, the yearly burden hour and cost estimates for this paperwork requirement are:

6

OSHA believes that employers do not repeat this training after the employees have been working in these
assignments.
7

Estimates of administration time include 30 minutes of travel time.

−16−

Burden hours: 132,833 employees x .08 hour = 10,627 hours
Cost: 10,627 hours x $16.95 = $180,128
Physician’s written opinion (§1910.1450(g)(4))
The Agency assumes that the physician writes an opinion for each medical consultation and
medical examination administered (for a total of 132,833 written opinions annually), and that an
office clerk takes five minutes (.08 hour) to distribute the written opinion to an employee. 8 Thus,
the estimated burden hours and cost of this requirement each year are:
Burden hours: 132,833 written opinions x .08 hour = 10,627 hours
Cost: 10,627 hours x $16.95 = $180,128
(E) Hazard identification (§1910.1450(h))
OSHA’s Hazard Communication (HC) Standard (§ 1910.1200) applies to the requirements
regarding labels and MSDSs specified by this provision of the Standard. 9 Therefore, the Agency
is accounting for the burden hours and cost resulting from these requirements under the
Information Collection Request (ICR) for the HC Standard, OMB Control Number 1218-0072.
(F) Use of respirators (§1910.1450(i))
The Agency accounts for the burden hours and cost resulting from this paragraph (including the
selection, use, and maintenance of respirators, and the development of a written respirator
protection program) under the Information Collection Request (ICR) for OSHA’s Respiratory
Protection Standard (§1910.134), OMB Control Number 1218-0099.
(G) Recordkeeping (§1910.1450(j))
General (§1910.1450(j)(1))
As noted above in section (A) (“Exposure Monitoring”) of this item, each laboratory facility
covered by the Standard develops a record of exposure monitoring results, for an annual total of
45,616 records. 10 In addition, the determinations made above in section (D) (“Medical
8

The five minutes does not include the annual burden for maintaining a record of each written opinion as
required by paragraph (j) of the Standard.
9

Paragraph (h)(2)(i) of the Standard requires employers to provide training in accordance with paragraph
(f), while paragraphs (h)(2)(ii) mandates CHPs specified by paragraph (e); the Agency included the burden-hour and
cost estimates for paragraphs (h)(2)(i) and (h)(2)(ii) in the determinations made under sections (C) and (B),
respectively, of this item.
10

OSHA assumes that the record is the list of exposure-monitoring results used for posting.

−17−

Consultation and Medical Examinations”) show that employers administer 132,833 medical
consultations and medical examinations annually, developing 132,833 medical records. Under
the requirements of this recordkeeping provision, the Agency estimates that an office clerk
spends five minutes (.08 hour) each year establishing and maintaining each of these records.
Therefore, the annual burden hours and cost associated with this recordkeeping requirement are:
Burden hours: [(45,616 exposure monitoring records) + (132,833 medical
records)] x .08 hour = 14,276 hours
Cost: 14,276 hours x $16.95 = $241,978
Access to records and transfer of records (§1910.1450(j)(2))
The determinations for this provision show that employers spend a total of 14,276 burden hours
at a cost of $241,978 providing access to exposure monitoring and medical records to
employees, their designated representatives, and OSHA compliance officers, as well as
transferring these records to NIOSH as required by paragraph (h) of §1910.1020 (“Access to
employee exposure and medical records”). The following sections describe in detail the burden
hour and cost determinations for this provision.
1. Employee access
For this determination, OSHA estimates that the exposure monitoring requirements of the
Standard cover all employees (1,660,408) in laboratory facilities, while 132,833 of these
employees have medical records (see previous determinations in this section). Additionally, the
Agency assumes that 10% (179,324) of the employees covered by these records request access to
them each year ((1,660,408 employees + 132,833 employees) x 10% = 179,324 employees).11
OSHA estimates that an office clerk takes five minutes (.08 hour) to retrieve and re-file each
requested record, resulting in the following annual burden hour and cost estimates:
Burden hours: 179,324 employees x .08 hours = 14,346 hours
Cost: 14,346 hours x $16.95 = $243,165
2. Federal access
The Agency determined that employers receive 639 requests annually for exposure monitoring
and medical records during inspections conducted by its compliance officers (see Item 14
below). In addition, OSHA finds that a laboratory supervisor spends five minutes (.08 hour)
informing a compliance officer of the location of the requested records. Accordingly, the
estimated yearly burden hours and cost of this provision are:

11

The Agency believes that employers receive minimal requests for exposure monitoring and medical
records from former employees, employees’ legal representatives, individuals and organizations to whom employees
give written authorization to exercise a right of access, and designated employee representatives; therefore, it did not
include these requests in this determination.

−18−

Burden hours: 639 requests x .08 hours = 51 hours
Cost: 51 hours x $41.29 = $2,106
Paragraph (h) of § 1910.1020 specifies the conditions for transferring exposure monitoring and
medical records to NIOSH. Based on information from the previous ICR, OSHA estimates that
four employers will send 333 sets of employee records to NIOSH each year during the period
covered by this ICR. The Agency assumes that an office clerk requires one hour to prepare and
send a set of records to NIOSH. Therefore, the annual estimated burden hours and cost of this
provision are:
Burden hours: 333 sets of records x 1 hour = 333 hours
Cost: 333 hours x $16.95 = $5,644
13.

Provide an estimate of the total annual cost burden to respondents or recordkeepers resulting from
the collection of information. (Do not include the cost of any hour burden shown in Items 12 and 14).
· The cost estimate should be split into two components: (a) a total capital and start-up cost
component (annualized over its expected useful life); and (b) a total operation and maintenance and
purchase of service component. The estimates should take into account costs associated with
generating, maintaining, and disclosing or providing the information. Include descriptions of
methods used to estimate major cost factors including system and technology acquisition, expected
useful life of capital equipment, the discount rate(s), and the time period over which costs will be
incurred. Capital and start-up costs include, among other items, preparations for collecting
information such as purchasing computers and software; monitoring, sampling, drilling and testing
equipment; and record storage facilities.
· If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and
explain the reasons for the variance. The cost of purchasing or contracting out information collection
services should be a part of this cost burden estimate. In developing cost burden estimates, agencies
may consult with a sample of respondent (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.

Capital Cost Determinations
Annual Medical Cost Determinations
OSHA found that the annual cost of providing employees with exposure monitoring, medical
consultations, and medical examinations is $35,978,301. The following sections describe the
cost determinations.

−19−

(A) Exposure monitoring
The Agency estimates that employers pay $60 to analyze an exposure monitoring sample.
According to the information provided above in section (A) (“Exposure Monitoring”) under Item
12, employers collect 45,616 exposure monitoring samples each year. Thus, the annual cost
associated with obtaining exposure monitoring samples is:
Cost: 45,616 samples x $60 = $2,736,960
(B) Medical consultation and medical examinations
OSHA identified the following costs for providing medical attention to employees: Medical
consultation (med consult), $133; medical examination (med exam), $301; and a combined
medical consultation and med examination (med consult-med exam), $434. 12 In addition, the
determinations made above in section (D) (“Medical consultation and medical examinations”)
show that each year employers administer 66,417 med consults, 33,208 med exams, and 33,208
med consults-med exams to employees. Accordingly, the yearly cost of providing medical
attention to employees is:
Cost: (66,417 med consults x $133) + (33,208 med exams x $301) +
(33,208 med consults-med exams x $434) = $33,241,341
OSHA found that the capital cost of providing employees with exposure monitoring, medical
consultations, and medical examinations is $32,615,952. The following sections describe the
capital-cost determinations.
(A) Exposure monitoring
The Agency estimates that employers pay $60 to analyze an exposure monitoring sample.
According to the information provided above in section (A) (“Exposure monitoring”) under Item
12, employers collect 43,300 exposure monitoring samples each year. Thus, the annual capital
cost associated with obtaining exposure monitoring samples is:
Cost: 43,300 samples x $60 = $2,598,000
(B) Medical consultation and medical examinations
OSHA identified the following capital costs for providing medical attention to employees:
Medical consultation (med consult), $125; medical examination (med exam), $282; and a
combined medical consultation and med examination (med consult-med exam), $407. In
addition, the determinations made above in section (D) (“Medical consultation and medical
12

The previous ICR assumed that each medical consultation cost $125, each medical examination $282, and
each combined medical consultation and medical examination $408. The Consumer Price Index (CPI) indicated a
6.6% increase in the price of professional medical services from 2004 to 2006; the cost of a medical consultation or
examination was assumed to have increased by 6.6% as well.

−20−

examinations”) show that each year employers administer 63,936 med consults, 31,968 med
exams, and 31,968 med consults-med exams to employees. Accordingly, the yearly capital cost
of providing medical attention to employees is:
Cost: (63,936 med consults x $125) + (31,968 med exams x $282) +
(31,968 med consults-med exams x $407) = $30,017,952
14.

Provide estimates of annualized cost of 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 paperwork requirements specified by the Standard cost the Federal government an estimated
$2,055 each year. The following sections provide the basis for this cost determination.
1. Transfer of records
The determination made above under section (G) (“Recordkeeping”) in Item 12 shows that
employers send 333 sets of exposure monitoring and medical records to NIOSH annually. The
Agency estimates that a NIOSH clerical/secretary (at a wage rate of $19.09 per hour) will spend
five minutes (.08 hour) processing each set of records. Therefore, the estimated annual cost of
this requirement to the Federal government is:
Cost: 333 set of records x .08 hour x $19.09 = $509
2. OSHA enforcement
The Agency estimates that a compliance officer (GS-12, step 5), at an hourly wage rate of
$37.89, spends five minutes (.08 hour) during an inspection reviewing the documents required
by the Standard. OSHA determines that its compliance officers will conduct 606 such
inspections during each year covered by this ICR. 13 In making this cost determination, the
Agency does not account for other occupational costs (e.g., equipment, overhead, and support
staff expenses) because it considers these costs to be normal expenses that would occur without
the collection of information requirements specified by the Standard. Thus, the estimated yearly
cost of these paperwork requirements to the Federal government is:
Cost: 639 inspections x .08 hour x $37.89 = $1,937

13

The Agency estimated the number of inspections by determining the inspection rate (1.4%) for all facilities
under the jurisdiction of the OSH Act (including both Federal OSHA and approved state-plan agencies) and then
multiplying the total number of laboratory facilities (i.e., 45,616) by this percentage (i.e., 45,616 facilities x 1.4% =
639 inspections).

−21−

15.

Explain the reasons for any program changes or adjustments reported in Items 13 or 14 of the OMB
form 83-1.

OSHA is requesting to increase the existing burden hour estimate for the collection of
information requirements in the Standard. In this regard, the Agency is requesting to increase
the current burden hour estimate from 270,636 hours to 281,419 hours, a total increase of 10,783
hours.
Additionally, the capital cost estimate has increased from $32,615,952 to $35,978,301 a total
increase of $3,362,349. This increase is a result of an increase in the cost of medical
consultations from $125 to $133, medical exams increasing from $282 to $301.
Table 2 below lists the current and requested burden hours of the information collection
requirements specified by the Standard, and describes each of the requested burden hour
adjustments.
Table 2
Requested Burden Hours and Adjustments

Information Collection
Requirement

Current
Burden
Hours

Requested
Burden
Hours

Estimated
Cost ($)

Adjustment

Explanation of Adjustment

394

There was an increase in the
number of facilities being
monitored (from 43,300 to
45,616).

185

There was an increase in the
number of facilities being
monitored (from 43,300 to
45,616).

1,158

There was an increase in the
number of facilities being
monitored (from 43,300 to
45,616).

620

There was an increase in the
number of employees
covered by the Standard
(from 1,598,385 to
1,660,408) which increased
the number of training
sessions (from 15,984 to
16,604).

A. Employee exposure
determination
(§1910.1450(d))
Initial monitoring and periodic
monitoring

Employee notification of
monitoring results

B. Chemical hygiene plan
(§1910.1450(e))

7,361

3,464

27,650

7,755

$320,204

3,649

$61,851

28,808

$1,189,482

C. Employee information and
training (§1910.1450(f))
15,984

16,604

$685,579

−22−

Information Collection
Requirement

Current
Burden
Hours

Requested
Burden
Hours

Estimated
Cost ($)

Adjustment

Explanation of Adjustment

6,511

There was an increase in the
number of employees
covered by the Standard
(from 1,598,385 to
1,660,408).

397

There was an increase in the
number of employees
covered by the Standard
(from 1,598,385 to
1,660,408) which increases
the number of employees
providing information to the
physician from 127,871 to
132,833).
There was an increase in the
number of employees
covered by the Standard
(from 1,598,385 to
1,660,408) which increases
the number of written
opinions 127,871 to
132,833).

D. Medical consultation
and medical
examinations
(§1910.1450(g))

General
167,832

174,343

$3,523,472

Information provided to the
physician
10,230

10,627

$180,128

Physician's written opinion

10,230

10,627

$180,128

397

E. Hazard identification
(§1910.1450(h))

0

0

0

0

F. Use of respirators
(§1910.1450(i))

0

0

0

0

G. Recordkeeping
(§1910.1450(j))
General

Access to records and transfer of

13,694

14,276

$241,978

582

14,191

14,730

$250,915

539

−23−

There was an increase in the
number of facilities being
monitored (from 43,300 to
45,616) and an increase in
the number of employees
covered by the Standard
(from 1,598,385 to
1,660,408).
There was an increase in the

Information Collection
Requirement

Current
Burden
Hours

Requested
Burden
Hours

Estimated
Cost ($)

Adjustment

records

Totals
16.

Explanation of Adjustment
number of facilities being
monitored (from 43,300 to
45,616) and an increase in
the number of employees
covered by the Standard
(from 1,598,385 to
1,660,408).

270,636

281,419

$6,633,737

10,783

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

OSHA will not publish the information collected under the Standard.
17.

If seeking approval to not display the expiration date for OMB approval of the information
collection, explain the reasons that display would be appropriate.

No forms are available for the Agency to display the expiration date.
18.

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

OSHA is not requesting an exception to the certification statement in Item 19 of the OMB 83-I.

−24−