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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 
et seq.
    (2) Applicant means any person who has submitted to EPA (or to a 
predecessor agency with responsibility for administering the Act) a 
registration

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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 
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 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.
    (f) [Reserved]
    (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 
designee.
    (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]

 


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