EPA Part 2 Section 307
TITLE 40--PROTECTION OF ENVIRONMENT
CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY
PART 2--PUBLIC INFORMATION--Table of Contents
Subpart B--Confidentiality of Business Information
Sec. 2.307 Special rules governing certain information obtained
under the Federal Insecticide, Fungicide and Rodenticide Act.
(a) Definitions. For the purposes of this section;
(1) Act means the Federal Insecticide, Fungicide and Rodenticide
Act, as amended, 7 U.S.C. 136 et seq., and its predecessor, 7 U.S.C. 135
(2) Applicant means any person who has submitted to EPA (or to a
predecessor agency with responsibility for administering the Act) a
statement or application for registration under the Act of a pesticide
or of an establishment.
(3) Registrant means any person who has obtained registration under
the Act of a pesticide or of an establishment.
(b) Applicability. This section applies to all information submitted
to EPA by an applicant or registrant 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 but incorporated by the applicant or registrant into a
submission in order to satisfy some requirement or condition of the Act
or of regulations which implement the Act. This section does not apply
to information supplied to EPA by a petitioner in support of a petition
for a tolerance under 21 U.S.C. 346a(d), unless the information is also
described by the first sentence of this paragraph.
(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) 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
(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 10(c) of the Act, 7 U.S.C. 136h(c),
the business may commence an action in an appropriate Federal district
court for a declaratory judgment;
(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's 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's commencement of an action in a
Federal court to obtain judicial review of the determination or to
obtain a declaratory judgment under section 10(c) of the Act 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.
(g) Substantive criteria for use in confidentiality determinations.
Section 2.208 applies without change to information to which this
section applies; however, no information to which this section applies
is voluntarily submitted information.
(h) Disclosure in special circumstances. (1) Section 2.209 applies
without change to information to which this section applies. In
addition, under section 12(a)(2)(D) of the Act, 7 U.S.C. 136j(a)(2)(D),
EPA possesses authority to disclose any information to which this
section applies to physicians, pharmacists, and other qualified persons
needing such information for the performance of their duties,
notwithstanding the fact that the information might otherwise be
entitled to confidential treatment under this subpart. Such authority
under section 12(a)(2)(D) of the Act may be exercised only in accordance
with paragraph (h)(2) or (h)(3) of this section.
(2) Information to which this section applies may be disclosed
(notwithstanding the fact that it might otherwise be entitled to
confidential treatment under this subpart) to physicians, pharmacists,
hospitals, veterinarians, law enforcement personnel, or governmental
agencies with responsibilities for protection of public health, and to
employees of any such persons or agencies, or to other qualified
persons, when and to the extent that disclosure is necessary in order to
treat illness or injury or to prevent imminent harm to persons,
property, or the environment, in the opinion of the Administrator or his
(3) Information to which this section applies may be disclosed
(notwithstanding the fact that it otherwise might be entitled to
confidential treatment under this subpart) to a person under contract to
EPA to perform work for EPA in connection with the Act or regulations
which implement the Act, if the EPA program office managing the contract
first determines in writing that such disclosure is necessary in order
that the contractor may carry out the work required by the contract. Any
such disclosure to a contractor shall be made only in accordance with
the procedure and requirements of Sec. 2.301(h)(2) (ii) through (iv).
(4) Information to which this section applies, and which relates to
formulas of products, may be disclosed at any public hearing or in
findings of fact issued by the Administrator, to the extent and in the
manner authorized by the Administrator or his designee.
[41 FR 36902, Sept. 1, 1976, as amended at 43 FR 40005, Sept. 8, 1978]