[Code of Federal Regulations]
[Title 40, Volume 1]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR2.306]
[Page 59-61]
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. Sec. ions 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. Sec. ion 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. Sec. ion
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
[[Page 60]]
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.
Sec. ion 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. Sec. ion 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
[[Page 61]]
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]
