[Code of Federal Regulations]
[Title 40 Volume 25]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR350.40]

[Page 416-418]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
      Subpart B--Disclosure of Trade Secret Information to Health 
                              Professionals
 
Sec. 350.40  Disclosure to health professionals.


    (a) Definitions. Medical emergency means any unforeseen condition 
which a health professional would judge to require urgent and 
unscheduled medical attention. Such a condition is one which results in 
sudden and/or serious symptom(s) constituting a threat to a person's 
physical or psychological well-being and which requires immediate 
medical attention to prevent possible deterioration, disability, or 
death.
    (b) The specific chemical identity, including the chemical name of a 
hazardous chemical, extremely hazardous substance, or a toxic chemical, 
is made available to health professionals, in accordance with the 
applicable provisions of this section.
    (c) Diagnosis or Treatment by Health Professionals in Non-Emergency 
Situations. (1) An owner or operator of a facility which is subject to 
the requirements of sections 311, 312, and 313, shall, upon request, 
provide the specific chemical identity, if known, of a hazardous 
chemical, extremely hazardous substance, or a toxic chemical to a health 
professional if:
    (i) The request is in writing;
    (ii) The request describes why the health professional has a 
reasonable basis to suspect that:
    (A) The specific chemical identity is needed for purposes of 
diagnosis or treatment of an individual,
    (B) The individual or individuals being diagnosed or treated have 
been exposed to the chemical concerned, and
    (C) Knowledge of the specific chemical identity of such chemical 
will assist in diagnosis or treatment.
    (iii) The request contains a confidentiality agreement which 
includes:
    (A) A description of the procedures to be used to maintain the 
confidentiality of the disclosed information; and
    (B) A statement by the health professional that he will not use the 
information for any purpose other than the health needs asserted in the 
statement of need authorized in paragraph (c)(1)(ii) of this section and 
will not release the information under any circumstances, except as 
authorized by the terms of the confidentiality agreement or by the owner 
or operator of the facility providing such information.
    (iv) The request includes a certification signed by the health 
professional stating that the information contained in the statement of 
need is true.
    (2) Following receipt of a written request, the facility owner or 
operator to whom such request is made shall provide the requested 
information to the health professional promptly.
    (d) Preventive Measures and Treatment by Local Health Professionals. 
(1) An owner or operator of a facility subject to the requirements of 
sections 311, 312,

[[Page 417]]

or 313 shall provide the specific chemical identity, if known, of a 
hazardous chemical, an extremely hazardous substance, or a toxic 
chemical to any health professional (such as a physician, toxicologist, 
epidemiologist, or nurse) if:
    (i) The requester is a local government employee or a person under 
contract with the local government;
    (ii) The request is in writing;
    (iii) The request describes with reasonable detail one or more of 
the following health needs for the information:
    (A) To assess exposure of persons living in a local community to the 
hazards of the chemical concerned.
    (B) To conduct or assess sampling to determine exposure levels of 
various population groups.
    (C) To conduct periodic medical surveillance of exposed population 
groups.
    (D) To provide medical treatment to exposed individuals or 
population groups.
    (E) To conduct studies to determine the health effects of exposure.
    (F) To conduct studies to aid in the identification of chemicals 
that may reasonably be anticipated to cause an observed health effect.
    (iv) The request contains a confidentiality agreement which 
includes:
    (A) A description of the procedures to be used to maintain the 
confidentiality of the disclosed information; and
    (B) A statement by the health professional that he will not use the 
information for any purpose other than the health needs asserted in the 
statement of need authorized in paragraph (d)(1)(iii) of this section 
and will not release the information under any circumstances except as 
may otherwise be authorized by the terms of such agreement or by the 
owner or operator of the facility person providing such information.
    (v) The request includes a certification signed by the health 
professional stating that the information contained in the statement of 
need is true.
    (2) Following receipt of a written request, the facility owner or 
operator to whom such request is made shall promptly provide the 
requested information to the local health professional.
    (e) Medical Emergency. (1) An owner or operator of a facility which 
is subject to the requirements of sections 311, 312, or 313 must provide 
a copy of a material safety data sheet, an inventory form, or a toxic 
chemical release form, including the specific chemical identity, if 
known, of a hazardous chemical, extremely hazardous substance, or a 
toxic chemical, to any treating physician or nurse who requests such 
information if the treating physician or nurse determines that:
    (i) A medical emergency exists as to the individual or individuals 
being diagnosed or treated;
    (ii) The specific chemical identity of the chemical concerned is 
necessary for or will assist in emergency or first-aid diagnosis or 
treatment; and,
    (iii) The individual or individuals being diagnosed or treated have 
been exposed to the chemical concerned.
    (2) Owners or operators of facilities must provide the specific 
chemical identity to the requesting treating physician or nurse 
immediately following the request, without requiring a written statement 
of need or a confidentiality agreement in advance.
    (3) The owner or operator may require a written statement of need 
and a written confidentiality agreement as soon as circumstances permit. 
The written statement of need shall describe in reasonable detail the 
factors set forth in paragraph (e)(1) of this section. The written 
confidentiality agreement shall be in accordance with paragraphs 
(c)(1)(iii) and (f) of this section.
    (f) Confidentiality Agreement. (1) The confidentiality agreement 
authorized in paragraphs (c)(1)(iii), (d)(1)(iv) and (e)(3) 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; and
    (iii) May not include requirements for the posting of a penalty 
bond.
    (g) Nothing in this regulation is meant to preclude the parties from 
pursuing any non-contractual remedies to the extent permitted by law, or 
from pursuing the enforcement remedy provided in section 325(e) of Title 
III.

[[Page 418]]

    (h) The health professional receiving the trade secret information 
may disclose it to EPA only under the following circumstances: The 
health professional must believe that such disclosure is necessary in 
order to learn from the Agency additional information about the chemical 
necessary to assist him in carrying out the responsibilities set forth 
in paragraphs (c), (d), and (e) of this section. Such information 
comprises facts regarding adverse health and environmental effects.