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EPA Part 2 Section 306

TITLE 40--PROTECTION OF ENVIRONMENT
 
CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY
 
PART 2--PUBLIC INFORMATION--Table of Contents
 
Subpart B--Confidentiality of Business Information
 

Sec. 2.306  Special rules governing certain information obtained under
the Toxic Substances Control Act.

    (a) Definitions. For the purposes of this section:
    (1) Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et 
seq.
    (2) Chemical substance has the meaning given it in section 3(2) of 
the Act, 15 U.S.C. 2602(2).
    (3)(i) Health and safety data means the information described in 
paragraphs (a)(3)(i) (A), (B), and (C) of this section with respect to 
any chemical substance or mixture offered for commercial distribution 
(including for test marketing purposes and for use in research and 
development), any chemical substance included on the inventory of 
chemical substances under section 8 of the Act (15 U.S.C. 2607), or any 
chemical substance or mixture for which testing is required under 
section 4 of the Act (15 U.S.C. 2603) or for which notification is 
required under section 5 of the Act (15 U.S.C. 2604).
    (A) Any study of any effect of a chemical substance or mixture on 
health, on the environment, or on both, including underlying data and 
epidemiological studies; studies of occupational exposure to a chemical 
substance or mixture; and toxicological, clinical, and ecological 
studies of a chemical substance or mixture;
    (B) Any test performed under the Act; and
    (C) Any data reported to, or otherwise obtained by, EPA from a study 
described in paragraph (a)(3)(i)(A) of this section or a test described 
in paragraph (a)(3)(i)(B) of this section.
    (ii) Notwithstanding paragraph (a)(3)(i) of this section, no 
information shall be considered to be health and safety data if 
disclosure of the information would--
    (A) In the case of a chemical substance or mixture, disclose 
processes used in the manufacturing or processing the chemical substance 
or mixture or,
    (B) In the case of a mixture, disclose the portion of the mixture 
comprised by any of the chemical substances in the mixture.
    (4) [Reserved]
    (5) Mixture has the meaning given it in section 3(8) of the Act, 15 
U.S.C. 2602(8).
    (6) Proceeding means any rulemaking, adjudication, or licensing 
conducted by EPA under the Act or under regulations which implement the 
Act, except for determinations under this subpart.
    (b) Applicability. This section applies to all information submitted 
to EPA for the purpose of satisfying some requirement or condition of 
the Act or of regulations which implement the Act, including information 
originally submitted to EPA for some other purpose and either relied 
upon to avoid some requirement or condition of the Act or incorporated 
into a submission in order to satisfy some requirement or condition of 
the Act or of regulations which implement the Act. Information will be 
considered to have been provided under the Act if the information could 
have been obtained under authority of the Act, whether the Act was cited 
as authority or not, and whether the information was provided directly 
to EPA or through some third person.
    (c) Basic rules which apply without change. Sections 2.201 through 
2.203, 2.206, 2.207, and 2.210 through 2.215 apply without change to 
information to which this section applies.
    (d) Initial action by EPA office. Section 2.204 applies to 
information to which this section applies, except that the provisions of 
paragraph (e)(3) of this section regarding the time allowed for seeking 
judicial review shall be reflected in any notice furnished to a business 
under Sec. 2.204(d)(2).
    (e) Final confidentiality determination by EPA legal office. Section 
2.205 applies to information to which this section applies, except 
that--
    (1) Notwithstanding Sec. 2.205(i), the General Counsel (or his 
designee), rather than the regional counsel, shall make the 
determinations and take the actions required by Sec. 2.205;
    (2) In addition to the statement prescribed by the second sentence 
of Sec. 2.205(f)(2), the notice of denial of a business confidentiality 
claim shall state that under section 20(a) of the Act, 15 U.S.C. 2619, 
the business may commence an action in an appropriate Federal district
court to prevent disclosure.
    (3) The following sentence is substituted for the third sentence of 
Sec. 2.205(f)(2): ``With respect to EPA's implementation of the 
determination, the notice shall state that (subject to Sec. 2.210) EPA 
will make the information available to the public on the thirty-first 
(31st) calendar day after the date of the business' receipt of the 
written notice (or on such later date as is established in lieu thereof 
under paragraph (f)(3) of this section), unless the EPA legal office has 
first been notified of the business' commencement of an action in a 
Federal court to obtain judicial review of the determination and to 
obtain preliminary injunctive relief against disclosure.''; and
    (4) Notwithstanding Sec. 2.205(g), the 31 calendar day period 
prescribed by Sec. 2.205(f)(2), as modified by paragraph (e)(3) of this 
section, shall not be shortened without the consent of the business.
    (f) [Reserved]
    (g) Substantive criteria for use in confidentiality determinations. 
Section 2.208 applies without change to information to which this 
section applies, except that health and safety data are not eligible for 
confidential treatment. No information to which this section applies is 
voluntarily submitted information.
    (h) Disclosure in special circumstances. Section 2.209 applies to 
information to which this section applies, except that the following two 
additional provisions apply to Sec. 2.209(c):
    (1) The official purpose for which the information is needed must be 
in connection with the agency's duties under any law for protection of 
health or the environment or for specific law enforcement purposes; and
    (2) EPA notifies the other agency that the information was acquired 
under authority of the Act and that any knowing disclosure of the 
information may subject the officers and employees of the other agency 
to the penalties in section 14(d) of the Act (15 U.S.C. 2613(d)).
    (i) Disclosure of information relevant in a proceeding. (1) Under 
section 14(a)(4) of the Act (15 U.S.C. 2613(a)(4)), any information to 
which this section applies may be disclosed by EPA when the information 
is relevant in a proceeding under the Act, notwithstanding the fact that 
the information otherwise might be entitled to confidential treatment 
under this subpart. However, any such disclosure shall be made in a 
manner that preserves the confidentiality of the information to the 
extent practicable without impairing the proceeding. Disclosure of 
information to which this section applies because of its relevance in a 
proceeding shall be made only in accordance with this paragraph (i).
    (2)-(4) The provisions of Sec. 2.301(g) (2), (3), and (4) are 
incorporated by reference as paragraphs (i) (2), (3), and (4), 
respectively, of this section.
    (j) Disclosure of information to contractors and subcontractors. (1) 
Under section 14(a)(2) of the Act (15 U.S.C. 2613(a)(2)), any 
information to which this section applies may be disclosed by EPA to a 
contractor or subcontractor of the United States performing work under 
the Act, notwithstanding the fact that the information otherwise might 
be entitled to confidential treatment under this subpart. Subject to the 
limitations in this paragraph (j), information to which this section 
applies may be disclosed:
    (i) To a contractor or subcontractor with EPA, if the EPA program 
office managing the contract first determines in writing that such 
disclosure is necessary for the satisfactory performance by the 
contractor or subcontractor of the contract or subcontract; or
    (ii) To a contractor or subcontractor with an agency other than EPA, 
if the EPA program office which provides the information to that agency, 
contractor, or subcontractor first determines in writing, in 
consultation with the General Counsel, that such disclosure is necessary 
for the satisfactory performance by the contractor or subcontractor of 
the contract or subcontract.
    (2)-(4) The provisions of Sec. 2.301(h)(2) (ii), (iii), and (iv) are 
incorporated by reference as paragraphs (j) (2), (3), and (4), 
respectively, of this section.
    (5) At the time any information is furnished to a contractor or 
subcontractor under this paragraph (j), the EPA office furnishing the 
information to the contractor or subcontractor shall notify the contractor
or subcontractor that the information was acquired under authority of the 
Act and that any knowing disclosure of the information may subject the 
contractor or subcontractor and its employees to the penalties in 
section 14(d) of the Act (15 U.S.C. 2613(d)).
    (k) Disclosure of information when necessary to protect health or 
the environment against an unreasonable risk of injury. (1) Under 
section 14(a)(3) of the Act (15 U.S.C 2613(a)(3)), any information to 
which this section applies may be disclosed by EPA when disclosure is 
necessary to protect health or the environment against an unreasonable 
risk of injury to health or the environment. However, any disclosure 
shall be made in a manner that preserves the confidentiality of the 
information to the extent not inconsistent with protecting health or the 
environment against the unreasonable risk of injury. Disclosure of 
information to which this section applies because of the need to protect 
health or the environment against an unreasonable risk of injury shall 
be made only in accordance with this paragraph (k).
    (2) If any EPA office determines that there is an unreasonable risk 
of injury to health or the environment and that to protect health or the 
environment against the unreasonable risk of injury it is necessary to 
disclose information to which this section applies that otherwise might 
be entitled to confidential treatment under this subpart, the EPA office 
shall notify the General Counsel in writing of the nature of the 
unreasonable risk of injury, the extent of the disclosure proposed, how 
the proposed disclosure will serve to protect health or the environment 
against the unreasonable risk of injury, and the proposed date of 
disclosure. Such notification shall be made as soon as practicable after 
discovery of the unreasonable risk of injury. If the EPA office 
determines that the risk of injury is so imminent that it is 
impracticable to furnish written notification to the General Counsel, 
the EPA office shall notify the General Counsel orally.
    (3) Upon receipt of notification under paragraph (k)(2) of this 
section, the General Counsel shall make a determination in writing 
whether disclosure of information to which this section applies that 
otherwise might be entitled to confidential treatment is necessary to 
protect health or the environment against an unreasonable risk of 
injury. The General Counsel shall also determine the extent of 
disclosure necessary to protect against the unreasonable risk of injury 
as well as when the disclosure must be made to protect against the 
unreasonable risk of injury.
    (4) If the General Counsel determines that disclosure of information 
to which this section applies that otherwise might be entitled to 
confidential treatment is necessary to protect health or the environment 
against an unreasonable risk of injury, the General Counsel shall 
furnish notice to each affected business of the contemplated disclosure 
and of the General Counsel's determination. Such notice shall be made in 
writing by certified mail, return receipt requested, at least 15 days 
before the disclosure is to be made. The notice shall state the date 
upon which disclosure will be made. However, if the General Counsel 
determines that the risk of injury is so imminent that it is 
impracticable to furnish such notice 15 days before the proposed date of 
disclosure, the General Counsel may provide notice by means that will 
provide receipt of the notice by the affected business at least 24 hours 
before the disclosure is to be made. This may be done by telegram, 
telephone, or other reasonably rapid means.
[43 FR 40003, Sept. 8, 1978, as amended at 44 FR 17674, Mar. 23, 1979; 
58 FR 462, Jan. 5, 1993]

 


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