SS_1218-0065 Final (08-24-10)

SUPPORTING STATEMENT FOR THE
INFORMATION COLLECTION REQUIREMENTS IN THE
REGULATION TITLED “ACCESS TO EMPLOYEE EXPOSURE
AND MEDICAL RECORDS” (29 CFR 1910.1020) 1, 2
(Office of Management and Budget (OMB)
Control No. 1218-0065 (August 2010)
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 worker 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).
Under the authority granted by the OSH Act, OSHA published a health regulation governing
access to employee exposure-monitoring 3 data and medical records 4 at 29 CFR 1910.1020 (the
1

The purpose of this supporting statement is to analyze and describe the burden hours and costs associated
with provisions of the Regulation that contain paperwork requirements; this supporting statement does not provide
information or guidance on how to comply with, or how to enforce, the Regulation.
2

The Construction, Shipyard Employment, Marine Terminals and Longshoring versions of this Regulation
(29 CFR 1926.33, 29 CFR 1915.1020, 29 CFR 1917.1, 29 CFR 1918.1, respectively) incorporate 29 CFR 1910.1020
by reference.

“Regulation”). The Regulation does not require employers to collect any information or to
establish any new systems of records. Rather, the Regulation requires that employers provide
employers and their designated representatives with access to exposure-monitoring and medical
records. In this regard, the Regulation specifies record-retention periods, record-access
procedures, and employee-information requirements. The Agency attributes the burden hours
and costs associated with conducting exposure monitoring and providing medical surveillance to
the toxic-chemical standards that specify these activities; therefore, OSHA did not include these
burden hours and costs in this information collection request (ICR).
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 following are the collection of information requirements as stated in the Regulation,
followed by discussions indicating how, by whom, and for what purpose the information is used
for each of these requirements.
A. Preservation of Employee Records (§1910.1020(d))
§1910.1020(d)(1) - Unless a specific occupational safety and health standard provides a different
period of time, each employer shall assure the preservation and retention of records as follows:
§1910.1020(d)(1)(i) - Employee medical records. The medical record for each employee
shall be preserved and maintained for at least the duration of employment plus thirty (30)
years, except that the following types of records need not be retained for any specified
period:
§1910.1020(d)(1)(i)(A) − Health insurance claims records maintained separately
from the employer's medical program and its records,
§1910.1020(d)(1)(i)(B) − First aid records (not including medical histories) of
one-time treatment and subsequent observation of minor scratches, cuts, burns,
splinters, and the like which do not involve medical treatment, loss of
consciousness, restriction of work or motion, or transfer to another job, if made

3

Paragraph (c)(5) of the Regulation defines an employee exposure record as: environmental (workplace)
monitoring or measurement of a toxic substance or harmful physical agent; biological monitoring results; and
material safety data sheets. In the absence of these items, exposure records include a chemical inventory or any
other record that provides the identity of the toxic chemical or harmful physical agent (i.e., its chemical, common, or
trade name), as well as the location and time of its use.
4

Paragraph (c)(6) of the Regulation specifies that an employee medical record documents an employee’s
health status and includes the following items: medical and employment questionnaires or histories; the results of
medical examinations and laboratory tests; medical opinions, diagnoses, progress notes, and recommendations; firstaid records; descriptions of treatments and prescriptions; and employee medical complaints. A physician, nurse, or
other healthcare personnel or technician makes or maintains the record.

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on-site by a non-physician and if maintained separately from the employer's
medical program and its records, and
§1910.1020(d)(1)(i)(C) - The medical records of employees who have worked for
less than (1) year for the employer need not be retained beyond the term of
employment if they are provided to the employee upon the termination of
employment.
§1910.1020(d)(1)(ii) - Employee exposure records. Each employee exposure record shall
be preserved and maintained for at least thirty (30) years, except that:
§1910.1020(d)(1)(ii)(A) - Background data to environmental (workplace)
monitoring or measuring, such as laboratory reports and worksheets, need only be
retained for one (1) year as long as the sampling results, the collection
methodology (sampling plan), a description of the analytical and mathematical
methods used, and a summary of other background data relevant to interpretation
of the results obtained, are retained for at least thirty (30) years; and
§1910.1020(d)(1)(ii)(B) - Material safety data sheets and paragraph (c)(5)(iv)
records concerning the identity of a substance or agent need not be retained for
any specified period as long as some record of the identity (chemical name if
known) of the substance or agent, where it was used, and when it was used is
retained for at least thirty (30) years; 5 and
§1910.1020(d)(1)(ii)(C) - Biological monitoring results designated as exposure
records by specific occupational safety and health standards shall be preserved
and maintained as required by the specific standard.
§1910.1020(d)(1)(iii) - Analyses using exposure or medical records. Each analysis using
exposure or medical records shall be preserved and maintained for at least thirty (30)
years.
Purpose: Exposure-monitoring and medical records are maintained principally to protect
worker health, to assist in the prevention or early diagnosis of adverse health affects, and to
provide valuable information to both workers and employers. The records also assist OSHA in
enforcing the Regulation. Sound public policy mandates that employers afford workers with a
meaningful opportunity to detect and resolve their occupationally-related health problems. This
requirement provides employers, workers and their designated representatives with the
information they need to detect, treat, and prevent occupational disease; thereby, permitting
workers to become involved in their own health management.
B. Access to Records (§1910.1020(e))
5

Material safety data sheets must be kept for those chemicals currently in use that are effected by the
Hazard Communication Standard in accordance with 29 CFR 1910.1200(g).

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General (§1910.1020(e)(1))
§1910.1020(e)(1)(i) - Whenever an employee or designated representative requests
access to a record, the employer shall assure that access is provided in a reasonable time,
place, and manner. If the employer cannot reasonably provide access to the record within
fifteen (15) working days, the employer shall within the fifteen (15) working days apprise
the employee or designated representative requesting the record of the reason for the
delay and the earliest date when the record can be made available.
Employee and designated representative access (§1910.1020(e)(2))
§1910.1020(e)(2)(i) Employee exposure records.
§1910.1020(e)(2)(i)(A) - Except as limited by paragraph (f) of this section, each
employer shall, upon request, assure the access to each employee and designated
representative to employee exposure records relevant to the employee. For the
purpose of this section, an exposure record relevant to the employee consists of:
§1910.1020(e)(2)(i)(A)(1) - A record which measures or monitors the amount of a
toxic substance or harmful physical agent to which the employee is or has been
exposed;
§1910.1020(e)(2)(i)(A)(2) - In the absence of such directly relevant records, such
records of other employees with past or present job duties or working conditions
related to or similar to those of the employee to the extent necessary to reasonably
indicate the amount and nature of the toxic substances or harmful physical agents
to which the employee is or has been subjected, and
§1910.1020(e)(2)(i)(A)(3) - Exposure records to the extent necessary to
reasonably indicate the amount and nature of the toxic substances or harmful
physical agents at workplaces or under working conditions to which the employee
is being assigned or transferred.
§1910.1020(e)(2)(i)(B) - Requests by designated representatives for unconsented
access to employee exposure records shall be in writing and shall specify with
reasonable particularity:

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§1910.1020(e)(2)(i)(B)(1) - The record requested to be disclosed; and
§1910.1020(e)(2)(i)(B)(2) - The occupational health need for gaining access to
these records. 6
§1910.1020(e)(2)(ii) - Employee medical records
§1910.1020(e)(2)(ii)(A) - Each employer shall, upon request, assure the access of
each employee to employee medical records of which the employee is the subject,
except as provided in paragraph (e)(2)(ii)(D) of this section.
§1910.1020(e)(2)(ii)(B) - Each employer shall, upon request, assure the access of
each designated representative to the employee medical records of any employee
who has given the designated representative specific written consent. Appendix
A to this section contains a sample form which may be used to establish specific
written consent for access to employee medical records.
§1910.1020(e)(2)(ii)(C) - Whenever access to employee medical records is
requested, a physician representing the employer may recommend that the
employee or designated representative:
§1910.1020(e)(2)(ii)(C)(1) - Consult with the physician for the purposes of
reviewing and discussing the records requested,
§1910.1020(e)(2)(ii)(C)(2) - Accept a summary of material facts and opinions in
lieu of the records requested, or
§1910.1020(e)(2)(ii)(C)(3) - Accept release of the requested records only to a
physician or other designated representative. 7
§1910.1020(e)(2)(ii)(D) - Whenever an employee requests access to his or her
employee medical records, and a physician representing the employer believes
that direct employee access to information contained in the records regarding a
specific diagnosis of a terminal illness or a psychiatric condition could be
detrimental to the employee's health, the employer may inform the employee that
access will only be provided to a designated representative of the employee
having specific written consent, and deny the employee's request for direct access
to this information only. Where a designated representative with specific written
consent requests access to information so withheld, the employer shall assure the
6

This provision imposes no burden on employers since employers are not developing this information.

7

It is usual and customary for physicians to discuss medical records with workers or their representatives
when disclosing medical records. The information in this paragraph would be part of the usual and customary
discussions.

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access of the designated representative to this information, even when it is known
that the designated representative will give the information to the employee.
§1910.1020(e)(2)(iii) - Analyses using exposure or medical records.
§1910.1020(e)(2)(iii)(A) - Each employer shall, upon request, assure the access of
each employee and designated representative to each analysis using exposure or
medical records concerning the employee's working conditions or workplace.
§1910.1020(e)(2)(iii)(B) - Whenever access is requested to an analysis which
reports the contents of employee medical records by either direct identifier (name,
address, social security number, payroll number, etc.) or by information which
could reasonably be used under the circumstances indirectly to identify specific
employees (exact age, height, weight, race, sex, date of initial employment, job
title, etc.), the employer shall assure that personal identifiers are removed before
access is provided. If the employer can demonstrate that removal of personal
identifiers from an analysis is not feasible, access to the personally identifiable
portions of the analysis need not be provided.
OSHA access (§1910.1020(e)(3))
§1910.1020(e)(3)(i) - Each employer shall, upon request, and without derogation of any
rights under the Constitution or the Occupational Safety and Health Act of 1970, 29
U.S.C. 651 et seq., that the employer chooses to exercise, assure the prompt access of
representatives of the Assistant Secretary of Labor for Occupational Safety and Health to
employee exposure and medical records and to analyses using exposure or medical
records. Rules of agency practice and procedure governing OSHA access to employee
medical records are contained in 29 CFR 1913.10.
§1910.1020(e)(3)(ii) - Whenever OSHA seeks access to personally identifiable employee
medical information by presenting to the employer a written access order pursuant to 29
CFR 1913.10(d), the employer shall prominently post a copy of the written access order
and its accompanying cover letter for at least fifteen (15) working days. 8
Purpose: Access to exposure and medical information enables workers and their designated
representatives to become directly involved in identifying and controlling occupational health
hazards, as well as managing and preventing occupationally-related health impairment and
disease. Accordingly, workers and their designated representatives can use exposure-monitoring
and medical-surveillance records to investigate the possible causes of worker health impairment
and disease. These records allow them to determine the association between specific adverse
8

Posting a copy of the written access order is not considered a collection of information requirement since
“the public disclosure of information originally supplied by the Federal government to the recipient for the purpose
of disclosure is not included in this definition” (5 CFR 1320.3(c)(1)). The term “definition” used in this statement
refers to a collection of information.

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health effects and occupational exposure to toxic chemicals. If they find such an association,
they can take action to control their exposure to toxic chemicals and harmful physical agents
through the use of respirators, protective work clothing, hygiene measures (i.e., showers, hand
and face washing before eating), and work practices that minimize dispersal of these hazards in
the workplace (i.e., immediately storing dust-laden scrap material in closed containers).
Implementing these controls also depends in large measure on worker cooperation. Cooperation
is most likely if workers know the identity of toxic chemicals or harmful physical agents in the
workplace, the magnitude of their exposure to these hazards, and the possible health effects of
such exposure.
Exposure-monitoring and medical-surveillance records permit a worker’s physician to diagnose,
treat, and possibly prevent permanent health impairment. Accordingly, a physician can compare
medical information collected at the start of employment with a worker’s current health status
and, having the worker’s exposure history available, determine if any health impairment involves
the worker’s occupational exposure to toxic chemicals.
Access to, and long-term maintenance of, exposure and medical records also facilitates
occupational-health research. Workers and their designated representative can make the
exposure and medical information in these records available to public and private organizations
and to scientists for epidemiological research. This research can determine if a significant
relationship exists between worker exposure to toxic chemicals and harmful physical agents and
health impairments and disease.
C. Trade Secrets (§1910.1020(f))
§1910.1020(f)(1) - Except as provided in paragraph (f)(2) of this section, nothing in this section
precludes an employer from deleting from records requested by a health professional, employee,
or designated representative any trade secret data which discloses manufacturing processes, or
discloses the percentage of a chemical substance in mixture, as long as the health professional,
employee, or designated representative is notified that information has been deleted. Whenever
deletion of trade secret information substantially impairs evaluation of the place where or the
time when exposure to a toxic substance or harmful physical agent occurred, the employer shall
provide alternative information which is sufficient to permit the requesting party to identify
where and when exposure occurred.
§1910.1020(f)(2) - The employer may withhold the specific chemical identity, including the
chemical name and other specific identification of a toxic substance from a disclosable record
provided that:
§1910.1020(f)(2)(i) - The claim that the information withheld is a trade secret can be
supported;
§1910.1020(f)(2)(ii) - All other available information on the properties and effects of the
toxic substance is disclosed;
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§1910.1020(f)(2)(iii) - The employer informs the requesting party that the specific
chemical identity is being withheld as a trade secret; and
§1910.1020(f)(2)(iv) - The specific chemical identity is made available to health
professionals, employees and designated representatives in accordance with the specific
applicable provisions of this paragraph.
§1910.1020(f)(3) - Where a treating physician or nurse determines that a medical emergency
exists and the specific chemical identity of a toxic substance is necessary for emergency or firstaid treatment, the employer shall immediately disclose the specific chemical identity of a trade
secret chemical to the treating physician or nurse, regardless of the existence of a written
statement of need or a confidentiality agreement. The employer may require a written statement
of need and confidentiality agreement, in accordance with the provisions of paragraphs (f)(4) and
(f)(5), as soon as circumstances permit.
§1910.1020(f)(4) - In non-emergency situations, an employer shall, upon request, disclose a
specific chemical identity, otherwise permitted to be withheld under paragraph (f)(2) of this
section, to a health professional, employee, or designated representative if:
§1910.1020(f)(4)(i) - The request is in writing; 9
§1910.1020(f)(4)(ii) - The request describes with reasonable detail one or more of the
following occupational health needs for the information:
§1910.1020(f)(4)(ii)(A) - To assess the hazards of the chemicals to which
employees will be exposed;
§1910.1020(f)(4)(ii)(B) - To conduct or assess sampling of the workplace
atmosphere to determine employee exposure levels;
§1910.1020(f)(4)(ii)(C) - To conduct pre-assignment or periodic medical
surveillance of exposed employees;
§1910.1020(f)(4)(ii)(D) - To provide medical treatment to exposed employees;
§1910.1020(f)(4)(ii)(E) - To select or assess appropriate personal protective
equipment for exposed employees;
§1910.1020(f)(4)(ii)(F) - To design or assess engineering controls or other
protective measures for exposed employees; and
§1910.1020(f)(4)(ii)(G) - To conduct studies to determine the health effects of
exposure.
9

This request is being provided to the employer, not generated by the employer; therefore the collection of
information is not applicable to the respondents in this ICR; the only burden is for the employer to maintain the
request.

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§1910.1020(f)(4)(iii) - The request explains in detail why the disclosure of the specific
chemical identity is essential and that, in lieu thereof, the disclosure of the following
information would not enable the health professional, employee or designated
representative to provide the occupational health services described in paragraph
(f)(4)(ii) of this section;
§1910.1020(f)(4)(iii)(A) - The properties and effects of the chemical;
§1910.1020(f)(4)(iii)(B) - Measures for controlling workers' exposure to the
chemical;
§1910.1020(f)(4)(iii)(C) - Methods of monitoring and analyzing worker exposure
to the chemical; and
§1910.1020(f)(4)(iii)(D) - Methods of diagnosing and treating harmful exposures
to the chemical;
§1910.1020(f)(4)(iv) - The request includes a description of the procedures to be used to
maintain the confidentiality of the disclosed information; and
§1910.1020(f)(4)(v) - The health professional, employee, or designated representative and
the employer or contractor of the services of the health professional or designated
representative agree in a written confidentiality agreement that the health professional,
employee or designated representative will not use the trade secret information for any
purpose other than the health need(s) asserted and agree not to release the information
under any circumstances other than to OSHA, as provided in paragraph (f)(7) of this
section, except as authorized by the terms of the agreement or by the employer.
§1910.1020(f)(5) - The confidentiality agreement authorized by paragraph (f)(4)(iv) of this
section:
§1910.1020(f)(5)(i) - May restrict the use of the information to the health purposes
indicated in the written statement of need;
§1910.1020(f)(5)(ii) - May provide for appropriate legal remedies in the event of a breach
of the agreement, including stipulation of a reasonable pre-estimate of likely damages;
and,
§1910.1020(f)(5)(iii) - May not include requirements for the posting of a penalty bond.
§1910.1020(f)(7) - If the health professional, employee or designated representative receiving the
trade secret information decides that there is a need to disclose it to OSHA, the employer who
provided the information shall be informed by the health professional prior to, or at the same
time as, such disclosure.
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§1910.1020(f)(8) - If the employer denies a written request for disclosure of a specific chemical
identity, the denial must:
§1910.1020(f)(8)(i) - Be provided to the health professional, employee or designated
representative within thirty days of the request;
§1910.1020(f)(8)(ii) - Be in writing;
§1910.1020(f)(8)(iii) - Include evidence to support the claim that the specific chemical
identity is a trade secret;
§1910.1020(f)(8)(iv) - State the specific reasons why the request is being denied; and,
§1910.1020(f)(8)(v) - Explain in detail how alternative information may satisfy the
specific medical or occupational health need without revealing the specific chemical
identity.
§1910.1020(f)(11)(ii) - If an employer demonstrates to OSHA that the execution of a
confidentiality agreement would not provide sufficient protection against the potential harm
from the unauthorized disclosure of a trade secret specific chemical identity, the Assistant
Secretary may issue such orders or impose such additional limitations or conditions upon the
disclosure of the requested chemical information as may be appropriate to assure that the
occupational health needs are met without an undue risk of harm to the employer.
§1910.1020(f)(12) - Notwithstanding the existence of a trade secret claim, an employer shall,
upon request, disclose to the Assistant Secretary any information which this section requires the
employer to make available. Where there is a trade secret claim, such claim shall be made no
later than at the time the information is provided to the Assistant Secretary so that suitable
determinations of trade secret status can be made and the necessary protections can be
implemented.
Purpose: The basic need for information on a chemical is to better assist a physician to
diagnose a medical condition. Trade secret claims have long been used in industry where
information, if disclosed, could jeopardize the competitive edge the manufacturer may have.
The provisions regarding trade secrets in 1910.1020 state that trade secrets must be revealed
whenever it is requested by a health professional, a worker, and a designated representative.
Both in emergencies and non-emergencies it may be necessary to gain this information. These
provisions provide the means to request this information from the manufacturer or the employer.

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D. Employee Information (§1910.1020(g))
§1910.1020(g)(1) - Upon an employee's first entering into employment, and at least annually
thereafter, each employer shall inform current employees covered by this section of the
following:
§1910.1020(g)(1)(i) - The existence, location, and availability of any records covered by
this section;
§1910.1020(g)(1)(ii) - The person responsible for maintaining and providing access to
records; and
§1910.1020(g)(1)(iii) - Each employee's rights of access to these records.
§1910.1020(g)(2) - Each employer shall keep a copy of this section and its appendices, and make
copies readily available, upon request, to employees. The employer shall also distribute to
current employees any informational materials concerning this section which are made available
to the employer by the Assistant Secretary of Labor for Occupational Safety and Health. 10
Purpose: The requirements of this provision reinforce the overall purpose of the Regulation to
enable employees to use exposure-monitoring and medical-surveillance records to investigate the
possible causes of health impairment and disease. These records allow employees to determine
the association between occupationally-related impairments and disease, and workplace
exposure to toxic chemicals and harmful physical agents. This determination will enable
employees to effectively treat these effects and to prevent such effects by controlling their
exposure to these hazards.
E. Transfer of Records (§1910.1020(h))
§1910.1020(h)(1) - Whenever an employer is ceasing to do business, the employer shall transfer
all records subject to this section to the successor employer. The successor employer shall
receive and maintain these records.
§1910.1020(h)(2) - Whenever an employer is ceasing to do business and there is no successor
employer to receive and maintain the records subject to this standard, the employer shall notify
affected current employees of their rights of access to records at least three (3) months prior to
the cessation of the employer's business.

10

Employers maintaining a copy of the Regulation, and making copies readily available, upon request, to
employees, and distributing to current employees any informational materials concerning this Regulation which are
made available to the employer by the Assistant Secretary of Labor for Occupational Safety and Health are exempt
from the definition of a collection of information since “the public disclosure of information originally supplied by
the Federal government to the recipient for the purpose of disclosure is not included in this definition” (5 CFR
1320.3(c)(1)).

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§1910.1020(h)(3) - Whenever an employer either is ceasing to do business and there is no
successor employer to receive and maintain the records, or intends to dispose of any records
required to be preserved for at least thirty (30) years, the employer shall:
§1910.1020(h)(3)(i) - Transfer the records to the Director of the National Institute for
Occupational Safety and Health (NIOSH) if so required by a specific occupational safety
and health standard; or
§1910.1020(h)(3)(ii) - Notify the Director of NIOSH in writing of the impending disposal
of records at least three (3) months prior to the disposal of the records.
§1910.1020(h)(4) - Where an employer regularly disposes of records required to be preserved for
at least thirty (30) years, the employer may, with at least (3) months notice, notify the Director of
NIOSH on an annual basis of the records intended to be disposed of in the coming year.
Purpose: These provisions stipulate requirements for preserving exposure-monitoring and
medical-surveillance records if an employer ceases to do business, thereby ensuring that these
records are available for review and analysis by workers, their designated representatives,
healthcare providers, and researchers.
3. Describe whether, and to what extent, the collection of information involves the use of automated,
electronic, mechanical, or other technological collection techniques or other forms of information technology,
e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of
collection. Also describe any consideration of using information technology to reduce burden.

Employers may use improved information technology when establishing and maintaining
exposure-monitoring and medical-surveillance records. Given the length of time employers
must maintain worker exposure-monitoring and medical records, and changing technology,
employers must ensure that electronic records can always be accessed and copied. OSHA wrote
the paperwork requirements of the Regulation 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 used or modified for use for the purposes described in Item 2 above.

The requirements to maintain information are specific to each employer and worker involved,
and no other source or agency duplicates these requirements or can make the required
information available to OSHA (i.e., the required information is available only from employers).
5. If the collection of information impacts small businesses or other small entities, describe any methods used
to minimize burden.

The information collection requirements of the Regulation 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

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conducted less frequently, as well as any technical or legal obstacles to reducing burden.

The Regulation only controls preservation of, and access to, exposure-monitoring and medicalsurveillance records; it does not directly require the collection of the exposure and medical
information. Providing workers, their designated representatives, healthcare providers, and
occupational-health researchers with access to these historical records enables them to: identify
toxic chemicals and harmful physical agents used in the workplace; control worker exposure to
these health hazards; and treat and prevent the occupationally-related health impairment and
disease that result from hazardous exposures. Accordingly, the Regulation helps to fulfill the
principal objective of the OSH Act (i.e., “to assure so far as possible every working man and
woman in the Nation safe and healthful working conditions”) by augmenting the requirements of
its substance-specific standards. Therefore, the Agency believes that any reduction in the
requirements of the Regulation would seriously interfere with the stated objective of the OSH
Act.
The Agency is proposing to delete provisions from §1910.1020(h)(3) and (h)(4) of its standard
regulating access to worker medical and exposure records in the Standard’s Improvement Project
– Phase III, Docket No. OSHA-2006-0049. The proposed deletion will eliminate the employers’
responsibility to send exposure and medical records to NIOSH.
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.

No special circumstances exist that require employers to collect information in the manner, or
using the procedures, described in this item.
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8. If applicable, provide a copy and identify the data and page number of publication in the Federal Register
of the agency's notice, required by 5 CFR 1320.8 (d), soliciting comments on the information collection prior
to submission to OMB. Summarize public comments received in response to that notice and describe actions
taken by the agency in response to these comments. Specifically address comments received on cost and hour
burden.
Describe efforts to consult with persons outside the agency to obtain their views on the availability of data,
frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any),
and on the data elements to be recorded, disclosed, or reported.
Consultation with representatives of those from whom information is to be obtained or those who must
compile records should occur at least once every 3 years, even if the collection of information activity is the
same as in prior periods. There may be circumstances that may preclude consultation in a specific situation.
These circumstances should be explained.

As required by the Paperwork Reduction Act of 1995 (U.S.C. 3506(c)(2)(A)), OSHA published
a Federal Register notice on April 26, 2010 (75 FR 21662) requesting public comment on its
proposed extension of the information collection requirements contained in the Regulation. This
notice was part of a preclearance consultation program to provide interested parties the
opportunity to comment on OSHA’s request for an extension by OMB of a previous approval of
the information collection requirements found in the Regulation. In response to this notice, the
Agency received one comment from Mr. Bruce E.Cunha, RN MS COHN-S, Manager of
Employee Health and Safety at the Marshfield Clinic. OSHA appreciates the comment in
response our Notice.
Mr. Cunha commented to reduce burden hours, OSHA should allow electronic signature
for workers to release their medical and exposure records; and, allow workers to approve the
release of any information from their worker health file until they rescind it instead of having to
do it annually. Mr. Cunha goes on to detail his situation working at a larger medical complex
that provides physicians and staff to number of hospitals and other health care facilities around
the state. Mr. Cunha’s staff must produce various medical documents including Hepatitis B
vaccination or declination documents, proof of vaccination, etc. The Marshfield clinic currently
has to send out requests for release of information annually to staff to physically sign and mail
back. When the releases for information are received, they are manually scanned into their
electronic system. Allowing electronic signature and employee approval until they rescind their
approval would greatly reduce the actual paperwork.
Based upon Mr. Cunha’s situation, it appears that 1910.1020(e)(2)(ii)(B) does not apply. Mr.
Cunha represents a medical professional staffing agency (medical clinic), and when a client (host
employer/hospital) requires proof of a clinic employee’s Hepatitis B vaccination for the purposes
of an employer’s (or host employer’s) occupational safety and health program, such a request is
not within the scope of §1910.1020. Instead, the intent of the written authorization provision
within §1910.1020 is only for when the employee is initiating a release of his/her medical
records to a designated representative and such a release by the employer may only be done on
the condition that it has a written signature from the employee authorizing the release.

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The provision in §1910.1020 was based on the requirements of Health Insurance Portability
Accountability Act (HIPAA), but this regulation specifically excludes the need for written
authorization for the administrative purposes of an employer conducting its occupational safety
and health program, per 45 CFR 164.512(b)(1)(v). Such a request is not in the scope of
§1910.1020, again, the intent of the written authorization provision in this standard is for when
the employee is authorizing release of medical information to a designated representative; and in
accordance with HIPAA (45 CFR 164.512), a covered entity may use or disclose protected
health information without written authorization of the individual when such use or disclosure is
required by law, such as when access is needed by OSHA – a public health authority that is
authorized by law to collect and/or receive information to determine if injuries/illnesses are
occurring, or have occurred, to prevent future injuries/illnesses, and/or determine compliance
with existing regulations
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 contained in medical records remains confidential,
OSHA developed 29 CFR 1913.10 to regulate access to these records.
11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior and
attitudes, religious beliefs, and other matters that are commonly considered private. This justification should
include the reasons why the agency considers the questions necessary, the specific uses to be made of the
information, the explanation to be given to persons from whom the information is requested, and any steps to
be taken to obtain their consent.

None of the provisions in the Regulation require the collection of sensitive information.
12. Provide estimates of the hour burden of the collection of information. The statement should:
▪

Indicate the number of respondents, frequency of response, annual hour burden, and an
explanation of how the burden was estimated. Unless directed to do so, agencies should not
conduct special surveys to obtain information on which to base hour burden estimates.
▪

Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden
on respondents is expected to vary widely because of differences in activity, size, or complexity, show
the range of estimated hour burden and explain the reasons for the variance. Generally, estimates
should not include burden hours for customary and usual business practices.

▪

If this request for approval covers more than one form, provide separate hour burden estimate
for 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 collection of
information, identifying and using appropriate wage rate categories. The cost of contracting out of

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paying outside parties for information should not be included here. Instead this cost should be
included in Item 13.

Summary of Burden-Hour and Cost Estimates
The following table provides a summary of the burden-hours and cost estimates for the
collection of information requirements of the Regulation, and described in Item 12 of this ICR.
Table 1
Summary of Burden Hours and Costs
Information Collection
Requirement

Current
Burden
Hours

A. Preservation of Records
B. Access to Records
C. Trade Secrets
D. Employee Information
E. Transfer of Records
Totals

124,919
123,386
73,482
395,461
2,939
720,187

Requested
Burden
Hours
117,400
116,412
69,059
359,360
2,778
665,009

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Change
(Adjustments
)
-7,519
-6,974
-4,423
-36,101
-161
-55,178

Estimated
Costs
$ 2,429,006
$ 8,056,875
$4,779,573
$24,871,306
$191,489
$40,328,249

Estimating the Number of Employers Affected by the Regulation
Based on the 2007 Economic Census, the Agency estimates that 4,790,859 establishments are in
North American Industrial Classification System (NAICS) codes that are covered by the
Regulation. The Agency estimated that 18.6% (891,100) of the total number of establishments
collect exposure-monitoring and/or medical information. The Agency estimated that 24%
(213,864) 11 of these employers developed their medical-surveillance programs and exposure
monitoring records to comply with OSHA’s substance-specific standards. Burden hours and
costs for medical surveillance and exposure monitoring contained in substance-specific standards
are accounted for in their corresponding information collection requests. Accordingly, the
Agency removed these employers from further analysis, resulting in an estimated total number of
677,236 employers affected by the Regulation.
The Ionizing Radiation (IR) Standard (29 CFR 1910.1096) does not specify access requirements
in the Standard; therefore, burden hours and costs were not included in the Information
Collection Request (OMB Control Number 1218-0103). The IR Standard (29 CFR 1910.1096)
covers an estimated 13,355 establishments. These establishments are included in this analysis,
resulting in a total of 690,591 employers (677,236 (employers affected by the Regulation) +
13,355 (employers affected by the IR Standard)).
Wage Rates
The Agency adopted the mean hourly wage rates from Employer Costs for Employee
Compensation, September 2009, U.S. Department of Labor, Bureau of Labor Statistics, Table 2,
http://stats.bls.gov/home.htm. Total compensation for these occupational categories includes an
adjustment of 30.3 percent (Employer Costs for Employee Compensation Summary, September
2009) for fringe benefits; this figure represents the average level of fringe benefits in the private
sector. The costs of labor used in this analysis are, therefore, estimates of total hourly
compensation. These hourly wages are:
Professional/Manager
Clerical/Secretary

$69.21
$20.69

Burden-Hour and Cost Determinations
The following sections summarize the methodology used for estimating the number of burden
hours and costs resulting from the information collection requirements of the Regulation. The
Regulation applies to employers whether or not other OSHA standards mandate preservation of,
and access to, exposure-monitoring and medical-surveillance records. The Agency accounts for
the burden hours and costs associated with the record-preservation and record-access
requirements of these other standards in the ICRs for those standards; the exception is the burden
11

“The Description and Evaluation of Medical Surveillance Programs in General Industry and Construction
Final Report,” prepared by OSHA’s Office of Regulatory Analysis, July 1993.

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hours and costs of the recordkeeping and record-access provisions of the IR Standard, which
OSHA includes with this ICR.
(A) Preservation of records (§1910.1020(d))
The Regulation requires employers to maintain worker exposure-monitoring and medicalsurveillance records and analyses for at least 30 years. However, for those workers who work
less than one year for an employer, the employer is not required to retain the medical records if
they are provided to the worker upon termination of employment. OSHA has no specific data
concerning the hours required for these record-preservation activities. Therefore, OSHA
assumes that a secretary (at a wage rate of $20.69 per hour) spends 10 minutes (.17 hour) each
year maintaining these records for each employer. The annual burden hour and cost estimates
for this provision are:
Burden hours: 690,591 employers x 0.17 hour = 117,400 hours
Cost: 117,400 hours x $20.69 = $2,429,006
(B) Access to records (§1910.1020(e))
Access by employees and their designated representatives
Paragraph (e) requires that employers provide workers and their designated representatives, on
request, with access to worker exposure-monitoring and medical-surveillance records, as well as
any analyses of these records. If an employer cannot provide workers or their designated
representatives’ access to records within 15 days, the employer must provide the reasons for the
delay to workers, or their designated representatives. Also, employers may need to remove
worker identifiers from analytical medical records. Finally, under certain circumstances,
employers may inform workers that access will only be provided to a designated representative
of the worker having specific written consent.
OSHA has no data on the number of access requests made by workers and their designated
representatives and, therefore, assumes that each employer will receive two such requests each
year, and that a manager takes 5 minutes (.08 hour) to appropriately respond to the request,
including retrieving and, if necessary, coping the records. The annual burden hour and cost
estimates for this paragraph are:
Burden hours: 690,591 employers x 2 requests x 0.08 hour = 110,495 hours
Cost: 110,495 hours x $69.21 = $7,647,359
OSHA access
Under paragraph (e)(3) of the Regulation, employers must provide OSHA with prompt access to
worker exposure-monitoring and medical-surveillance records, and to any analyses associated
with these records. Currently, the Agency makes a request for these records and analyses during
an inspection of an employer’s facility. In FY 2009, Federal OSHA and state-plan occupational
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safety and health agencies conducted 97,547 (Federal OSHA, 38,973 inspections, and State-plan
inspections, 58,574) such inspections. OSHA takes burden hours and costs for employers
providing access to these records in the Information Collection Request for each of its health
standards; accordingly, OSHA subtracted 23,588 inspections from 97,547 inspections to avoid
double counting the burden hours and costs. Therefore, OSHA will request access to records
under the Regulation in 73,959 inspections. OSHA estimates that a manager, at a wage rate of
$69.21 an hour, takes 5 minutes (.08 hour) to provide an OSHA compliance officer with access
to worker exposure-monitoring and medical-surveillance records, and associated analyses. The
annual burden hour and cost estimates for this requirement are:
Burden hours: 73,959 inspections x .08 hour = 5,917 hours
Cost: 5,917 hours x $69.21 = $409,516
In summary, the total burden hours and costs for employers to provide workers, their designated
representatives, and OSHA with access to these records are:
Burden hours: 110,495 (access by workers and their designated representatives) +
5,917 (OSHA access) = 116,412 hours
Cost: $7,647,359 (access by workers and their designated representatives) +
$409,516 (OSHA access) = $8,056,875
(C) Trade secrets (§1910.1020(f))
Paragraph (f) contains several collection of information requirements addressing when
employers must modify, or withhold, information regarding trade-secret information (including
the specific chemical identity). Such collection of information requirements include: providing
alternative information to workers or the designated representative when trade-secret information
is not provided; an explanation of why trade-secret information or specific information is being
withheld; information denying a written request for disclosure; written confidentiality
agreements between employers and/or health professionals, workers, or designated
representatives; and disclosing the information to OSHA.
OSHA assumes that 10% of employers must respond to a trade-secret request, and estimates that
a manager (at a wage rate of $69.21 per hour) requires one hour to prepare the necessary
documentation, depending upon the circumstances involved in developing or disclosing the
trade-secret information. The annual burden hour and cost estimates for this provision are:
Burden hours: 690,591 employers x 10% x 1 hour = 69,059 hours
Cost: 69,059 hours x $69.21 = $4,779,573

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(D) Employee information (§1910.1020(g))
When workers first enter employment, and at least annually thereafter, employers must notify
them of: the existence, location, and availability of any records covered by the Regulation; who
is responsible for maintaining and providing access to these records; and the workers’ right to
access their personnel records. OSHA estimates that a professional takes the following times to
provide the required information: 5 minutes (.08 hour) for each new worker; and 10 minutes
(.17 hour) during a single session for all of an employer’s existing workers (for a total of
690,591 single sessions for 690,591 employers). Based on available data regarding new
workers, the Agency assumes that employers must notify 3,024,499 new workers of this
information each year. 12 The annual burden hour and cost estimates for this provision are:
Burden hours: (3,024,499 new workers x .08 hour = 241,960 hours) +
(690,591 single sessions for existing workers x .17 hour =
117,400 hours) = 359,360 hours
Cost: 359,360 hours x $69.21 = $ 24,871,306
(E) Transfer of records (§1910.1020(h))
Whenever an employer ceases to do business, paragraph (h)(1) of the Regulation requires the
employer to transfer all records covered by the Regulation to the successor employer. This
paragraph requires employers who cease doing business and have no successor employer to:
notify current workers who have records covered by the Regulation of their right to access these
records, and to do so prior to cessation of business; transfer the records to the National Institute
for Occupational Safety and Health (NIOSH) if so required by another OSHA standard; and
provide NIOSH with written notice of the impending disposal of records that the Regulation
requires the employer to maintain for at least 30 years, and to do so at least 3 months prior to
such disposal.
Employers who cease doing business within the period specified for retaining the records, and
who have no successor employer, must transmit these records to NIOSH if so requested by
NIOSH. Employers who remain in business for the entire retention period must, before
disposing of these records, notify NIOSH in writing of the impending disposal, and transfer the
records to NIOSH if it requests the records within 3 months of being so notified.
According to NIOSH, they receive 93 records per year. OSHA estimates a clerical earning
$20.69 will take 10 minutes (.17 hour) to prepare and submit the records to NIOSH.
12

OSHA determined the total number of new employees each year by assuming 10.63 employees for each
establishment covered by the Regulation, and multiplying this figure by the total number of covered establishments
(690,591), for a total of 7,340,982 employees. To this total, the Agency added 17,896 employees for establishments
covered by the Ionizing Radiation (IR) Standard, assuming 1.34 employees for each of the 13,355 establishments
covered by the IR Standard. OSHA then multiplied the total number of employees covered by both the Regulation
and the IR Standard (7,358,878) by an assumed turnover rate of 41.1% (Hires Rate, total Nonfarm—JOLTS, Bureau
of Labor Statistics, 2008), resulting in a total of 3,024,499 new employees each year.

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Burden hours: 93 records x .17 hour = 16 hours
Cost: 16 hours x $20.69 = $331
.
For purposes of informing workers of their right to access their records when the employer is
ceasing business, OSHA assumes 5% of the 690,591 establishments will cease business each
year, and a manager will take 5 minutes (.08 hour) to inform workers of their rights to access
their medical and exposure-monitoring records.
Burden hours: 690,591 establishments x .05 x .08 hour = 2,762 hours
Cost: 2,762 hours x $69.21 = $191,158
13. Provide an estimate of the total annual cost burden to respondents or recordkeepers resulting from the
collection of information. (Do not include the cost of any hour burden shown in Items 12 and 14.)
▪

The cost estimate should be split into two components: (a) A total capital and start-up cost
component (annualized over its expected useful life); and (b) a total operation and maintenance and
purchase of services component. The estimates should take into account costs associated with
generating, maintaining, and disclosing or providing the information. Include descriptions of
methods used to estimate major cost factors including system and technology acquisition, expected
useful life of capital equipment, the discount rate(s), and the time period over which costs will be
incurred. Capital and start-up costs include, among other items, preparation 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.

Item 12 above provides the total cost of the information collection requirements specified by 29
CFR 1910.1020.
14. Provide estimates of the annualized cost to the Federal government. Also, provide a description of the
method used to estimate cost, which should include quantification of hours, operational expenses (such as
equipment, overhead, printing and support staff), and any other expense that would not have been incurred
without this collection of information. Agencies also may aggregate cost estimates from Items 12, 13, and 14
in a single table.

The Federal government incurs costs when, as required by paragraph (h)(3), employers who
cease doing business without a successor employer transfer records covered by the Regulation to
NIOSH.
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According to NIOSH, NIOSH receives, on average, 93 records per year. Once NOISH receives
and processes these records, the records are then transferred to the Federal Records Center
(FRC) where they remain stored for 40-year period retention period as specified by the Centers
for Disease Control and Prevention Records Schedule. 13 NIOSH estimates that the following are
costs for processing the records, as well as for transferring and storing the records at the FRC:
(a) Processing additional Records:
93 records x .07 hour x $21.23 (GS 7 -Step 4) = $138
(b) Preparing records inventory and completing required CDC and FRC Paperwork:
93 records x 8 hours/year x (GS 9 – Step 5) (technical information specialist) x
$26.76 = $19,909
(c) Transporting and delivering the records to the Dayton FRC:
4 hours x (GS 6 - step 4) x $19.11 = $76
(d) FRC storage costs:
93 records x $0.03 record/year x 40 years = $112.
Cost to NIOISH = $138 + $19,909 + $76 + $112 = $20,235
Costs to the Federal government occur when OSHA compliance officers review the exposuremonitoring and medical-surveillance records, and any analyses associated with these records,
which employers must maintain under the Regulation. The Agency estimates that a compliance
officer (GS-12/5), at an hourly wage rate of $40.66, spends 10 minutes (.17 hour) during each
inspection reviewing records covered by the Regulation. Other costs, such as equipment,
overhead, and support-staff expenses, would occur without these collection of information
requirements, and OSHA considers these costs to be normal operating expenses. Based on the
73,959 inspections conducted in 2009, by OSHA and state-plan occupational safety and health
agencies (see Item 12), the Agency estimates that the number of hours and the cost that it
expends each year on conducting inspections associated with the Regulation are:
Hours: 73,959 inspections x .17 hour = 12,573 hours
Cost: 12,573 hours x $40.66 = $511,218
Total Cost to Federal government: $20,235 NIOSH processing/storing + $511,218 for
OSHA compliance officers to review = $531,453
13

The retention period for employee records received prior to 2006 is 40 years, so that all records currently
at the FRC will incur storage costs for that period. Beginning in 2006, the CDC Records Schedule was changed to
reduce the retention period to 30 years.

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

The Agency is requesting an adjustment decrease of 55,178 hours. This decrease is the result of
the Agency using the latest NAICS codes covered by the Regulation to update the number of
establishments. The number of establishments decreased from 5,108,244 to 4,790,859. There is
a burden hour increase of 16 hours for employers to transfer records to NIOSH.
16. For collection of information whose results will be published, outline plans for tabulations 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 of information, completion of the report,
publication dates, and other actions.

OSHA will not publish the information collected under the Regulation.
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.

OSHA is not seeking an exception to the certification statement.

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