29 C.F.R. § 1910.1020
(c)
Definitions—
(1)
Access means the right and opportunity to examine and copy.
(2)
Analysis using exposure or medical records means any compilation of data or any statistical study based at least in part on information collected from individual employee exposure or medical records or information collected from health insurance claims records, provided that either the analysis has been reported to the employer or no further work is currently being done by the person responsible for preparing the analysis.
(3)
Designated representative means any individual or organization to whom an employee gives written authorization to exercise a right of access. For the purposes of access to employee exposure records and analyses using exposure or medical records, a recognized or certified collective bargaining agent shall be treated automatically as a designated representative without regard to written employee authorization.
(4)
Employee means a current employee, a former employee, or an employee being assigned or transferred to work where there will be exposure to toxic substances or harmful physical agents. In the case of a deceased or legally incapacitated employee, the employee's legal representative may directly exercise all the employee's rights under this section.
(5)
Employee exposure record means a record containing any of the following kinds of information:
(i)
Environmental (workplace) monitoring or measuring of a toxic substance or harmful physical agent, including personal, area, grab, wipe, or other form of sampling, as well as related collection and analytical methodologies, calculations, and other background data relevant to interpretation of the results obtained;
(ii)
Biological monitoring results which directly assess the absorption of a toxic substance or harmful physical agent by body systems (e.g., the level of a chemical in the blood, urine, breath, hair, fingernails, etc) but not including results which assess the biological effect of a substance or agent or which assess an employee's use of alcohol or drugs;
(iii)
Material safety data sheets indicating that the material may pose a hazard to human health; or
(iv)
In the absence of the above, a chemcial inventory or any other record which reveals where and when used and the identity (e.g., chemical, common, or trade name) of a toxic substance or harmful physical agent.
(6)
(i)
Employee medical record means a record concerning the health status of an employee which is made or maintained by a physician, nurse, or other health care personnel or technician, including:
(A)
Medical and employment questionnaires or histories (including job description and occupational exposures),
(B)
The results of medical examinations (pre-employment, pre-assignment, periodic, or episodic) and laboratory tests (including chest and other X-ray examinations taken for the purposes of establishing a base-line or detecting occupational illness, and all biological monitoring not defined as an “employee exposure record”),
(C)
Medical opinions, diagnoses, progress notes, and recommendations,
(E)
Descriptions of treatments and prescriptions, and
(F)
Employee medical complaints.
(ii)
“Employee medical record” does not include medical information in the form of:
(A)
Physical specimens (e.g., blood or urine samples) which are routinely discarded as a part of normal medical practice; or
(B)
Records concerning health insurance claims if maintained separately from the employer's medical program and its records, and not accessible to the employer by employee name or other direct personal identifier (e.g., social security number, payroll number, etc.); or
(C)
Records created solely in preparation for litigation which are privileged from discovery under the applicable rules of procedure or evidence; or
(D)
Records concerning voluntary employee assistance programs (alcohol, drug abuse, or personal counseling programs) if maintained separately from the employer's medical program and its records.
(7)
Employer means a current employer, a former employer, or a successor employer.
(8)
Exposure— or exposed means that an employee is subjected to a toxic substance or harmful physical agent in the course of employment through any route of entry (inhalation, ingestion, skin contact or absorption, etc.), and includes past exposure and potential (e.g., accidental or possible) exposure, but does not include situations where the employer can demonstrate that the toxic substance or harmful physical agent is not used, handled, stored, generated, or present in the workplace in any manner different from typical non-occupational situations.
(9)
Health Professional means a physician, occupational health nurse, industrial hygienist, toxicologist, or epidemiologist, providing medical or other occupational health services to exposed employees.
(10)
Record means any item, collection, or grouping of information regardless of the form or process by which it is maintained (e.g., paper document, microfiche, microfilm, X-ray film, or automated data processing).
(11)
Specific chemical identity means the chemical name, Chemical Abstracts Service (CAS) Registry Number, or any other information that reveals the precise chemical designation of the substance.
(12)
(i)
Specific written consent means a written authorization containing the following:
(A)
The name and signature of the employee authorizing the release of medical information,
(B)
The date of the written authorization,
(C)
The name of the individual or organization that is authorized to release the medical information,
(D)
The name of the designated representative (individual or organization) that is authorized to receive the released information,
(E)
A general description of the medical information that is authorized to be released,
(F)
A general description of the purpose for the release of the medical information, and
(G)
A date or condition upon which the written authorization will expire (if less than one year).
(ii)
A written authorization does not operate to authorize the release of medical information not in existence on the date of written authorization, unless the release of future information is expressly authorized, and does not operate for more than one year from the date of written authorization.
(iii)
A written authorization may be revoked in writing prospectively at any time.
(13)
Toxic substance or harmful physical agent means any chemical substance, biological agent (bacteria, virus, fungus, etc.), or physical stress (noise, heat, cold, vibration, repetitive motion, ionizing and non-ionizing radiation, hypo-or hyperbaric pressure, etc.) which:
(i)
Is listed in the latest printed edition of the National Institute for Occupational Safety and Health (NIOSH) Registry of Toxic Effects of Chemical Substances (RTECS), which is incorporated by reference as specified in
§ 1910.6; or
(ii)
Has yielded positive evidence of an acute or chronic health hazard in testing conducted by, or known to, the employer; or
(iii)
Is the subject of a material safety data sheet kept by or known to the employer indicating that the material may pose a hazard to human health.
(14)
Trade secret means any confidential formula, pattern, process, device, or information or compilation of information that is used in an employer's business and that gives the employer an opportunity to obtain an advantage over competitors who do not know or use it.
(f)
Trade secrets.
(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.
(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:
(i)
The claim that the information withheld is a trade secret can be supported;
(ii)
All other available information on the properties and effects of the toxic substance is disclosed;
(iii)
The employer informs the requesting party that the specific chemical identity is being withheld as a trade secret; and
(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.
(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 first-aid 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.
(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:
(i)
The request is in writing;
(ii)
The request describes with reasonable detail one or more of the following occupational health needs for the information:
(A)
To assess the hazards of the chemicals to which employees will be exposed;
(B)
To conduct or assess sampling of the workplace atmosphere to determine employee exposure levels;
(C)
To conduct pre-assignment or periodic medical surveillance of exposed employees;
(D)
To provide medical treatment to exposed employees;
(E)
To select or assess appropriate personal protective equipment for exposed employees;
(F)
To design or assess engineering controls or other protective measures for exposed employees; and
(G)
To conduct studies to determine the health effects of exposure.
(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:
(A)
The properties and effects of the chemical;
(B)
Measures for controlling workers' exposure to the chemical;
(C)
Methods of monitoring and analyzing worker exposure to the chemical; and,
(D)
Methods of diagnosing and treating harmful exposures to the chemical;
(iv)
The request includes a description of the procedures to be used to maintain the confidentiality of the disclosed information; and,
(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.
(5)
The confidentiality agreement authorized by paragraph (f)(4)(iv) of this section—
(i)
May restrict the use of the information to the health purposes indicated in the written statement of need;
(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,
(iii)
May not include requirements for the posting of a penalty bond.
(6)
Nothing in this section is meant to preclude the parties from pursuing non-contractual remedies to the extent permitted by law.
(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.
(8)
If the employer denies a written request for disclosure of a specific chemical identity, the denial must:
(i)
Be provided to the health professional, employee or designated representative within thirty days of the request;
(iii)
Include evidence to support the claim that the specific chemical identity is a trade secret;
(iv)
State the specific reasons why the request is being denied; and,
(v)
Explain in detail how alternative information may satisfy the specific medical or occupational health need without revealing the specific chemical identity.
(9)
The health professional, employee, or designated representative whose request for information is denied under
paragraph (f)(4) of this section may refer the request and the written denial of the request to OSHA for consideration.
(10)
When a heath professional employee, or designated representative refers a denial to OSHA under
paragraph (f)(9) of this section, OSHA shall consider the evidence to determine if:
(i)
The employer has supported the claim that the specific chemical identity is a trade secret;
(ii)
The health professional employee, or designated representative has supported the claim that there is a medical or occupational health need for the information; and
(iii)
The health professional, employee or designated representative has demonstrated adequate means to protect the confidentiality.
(11)
(i)
If OSHA determines that the specific chemical identity requested under
paragraph (f)(4) of this section is not a bona fide trade secret, or that it is a trade secret but the requesting health professional, employee or designated representatives has a legitimate medical or occupational health need for the information, has executed a written confidentiality agreement, and has shown adequate means for complying with the terms of such agreement, the employer will be subject to citation by OSHA.
(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.
(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.
(13)
Nothing in this paragraph shall be construed as requiring the disclosure under any circumstances of process or percentage of mixture information which is trade secret.
Notes, amendments, and revision history
Amendments
[53 FR 38163, Sept. 29, 1988; 53 FR 49981, Dec. 13, 1988, as amended at 54 FR 24333, June 7, 1989; 55 FR 26431, June 28, 1990; 61 FR 9235, Mar. 7, 1996. Redesignated at 61 FR 31430, June 20, 1996, as amended at 71 FR 16673, Apr. 3, 2006; 76 FR 33608, June 8, 2011]
Authority
Authority: 33 U.S.C. 941; 29 U.S.C. 653, 655, 657; Secretary of Labor's Order No. 12-71 (36 FR 8754); 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR 55355), 1-2012 (77 FR 3912), 08-2020 (85 FR 58393), or 07-2025 (90 FR 27878); 29 CFR part 1911; and 5 U.S.C. 553, as applicable.
Source
Source: 39 FR 23502, June 27, 1974, unless otherwise noted.
Source
Source: 39 FR 23502, June 27, 1974, unless otherwise noted. Redesignated at 40 FR 23072, May 28, 1975.
Amendments
[53 FR 38163, Sept. 29, 1988; 53 FR 49981, Dec. 13, 1988, as amended at 54 FR 24333, June 7, 1989; 55 FR 26431, June 28, 1990; 61 FR 9235, Mar. 7, 1996. Redesignated at 61 FR 31430, June 20, 1996, as amended at 71 FR 16673, Apr. 3, 2006; 76 FR 33608, June 8, 2011]