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EPA Part 2 Section 308

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

Sec. 2.308  Special rules governing certain information obtained
under the Federal Food, Drug and Cosmetic Act.

    (a) Definitions. For the purposes of this section:
    (1) Act means the Federal Food, Drug and Cosmetic Act, as amended, 
21 U.S.C. 301 et seq.
    (2) Petition means a petition for the issuance of a regulation 
establishing a tolerance for a pesticide chemical or exempting the 
pesticide chemical from the necessity of a tolerance, pursuant to 
section 408(d) of the Act, 21 U.S.C. 346a(d).
    (3) Petitioner means a person who has submitted a petition to EPA 
(or to a predecessor agency).
    (b) Applicability. (1) This section applies only to business 
information submitted to EPA (or to an advisory committee established 
under the Act) by a petitioner, solely in support of a petition which 
has not been acted on by the publication by EPA of a regulation 
establishing a tolerance for a pesticide chemical or exempting the 
pesticide chemical from the necessity of a tolerance, as provided in 
section 408(d) (2) or (3) of the Act, 21 U.S.C. 346a(d) (2) or (3).
    (2) Section 2.307, rather than this section, applies to information 
described by the first sentence of Sec. 2.307(b) (material incorporated 
into submissions in order to satisfy the requirements of the Federal 
Insecticide, Fungicide and Rodenticide Act, as amended), even though 
such information was originally submitted by a petitioner in support of 
a petition.
    (3) This section does not apply to information gathered by EPA under 
a proceeding initiated by EPA to establish a tolerance under section 
408(e) of the Act, 21 U.S.C. 346a(e).
    (c) Basic rules which apply without change. Sections 2.201, 2.202, 
2.206, 2.207, and 2.210 through 2.215 apply without change to 
information to which this section applies.
    (d) Effect of submission of information without claim. Section 2.203 
(a) and (b) apply without change to information to which this section 
applies. Section 2.203(c), however, does not apply to information to 
which this section applies. A petitioner's failure to assert a claim 
when initially submitting a petition shall not constitute a waiver of 
any claim the petitioner may have.
    (e) Initial action by EPA office. Section 2.204 applies to 
information to which this section applies, except that--
    (1) Unless the EPA office has on file a written waiver of a 
petitioner's claim, a petitioner shall be regarded as an affected 
business, a petition shall be treated as if it were covered by a 
business confidentiality claim, and an EPA office acting under 
Sec. 2.204(d) shall determine that the information in the petition is or 
may be entitled to confidential treatment and shall take action in 
accordance with Sec. 2.204(d)(1);
    (2) In addition to other required provisions of any notice furnished 
to a petitioner under Sec. 2.204(e), such notice shall state that--
    (i) Section 408(f) of the Act, 21 U.S.C. 346a(f), affords absolute 
confidentiality to information to which this section applies, but after
publication by EPA of a regulation establishing a tolerance (or exempting
the pesticide chemical from the necessity of a tolerance) neither the Act
nor this section affords any protection to the information;
    (ii) Information submitted in support of a petition which is also 
incorporated into a submission in order to satisfy a requirement or 
condition of the Federal Insecticide, Fungicide and Rodenticide Act, as 
amended, 7 U.S.C. 136 et seq., is regarded by EPA as being governed, 
with respect to business confidentiality, by Sec. 2.307 rather than by 
this section;
    (iii) Although it appears that this section may apply to the 
information at this time, EPA is presently engaged in determining 
whether for any reason the information is entitled to confidential 
treatment or will be entitled to such treatment if and when this section 
no longer applies to the information; and
    (iv) Information determined by EPA to be covered by this section 
will not be disclosed for as long as this section continues to apply, 
but will be made available to the public thereafter (subject to 
Sec. 2.210) unless the business furnishes timely comments in response to 
the notice.
    (f) 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 in all cases make the 
determinations and take the actions required by Sec. 2.205;
    (2) In addition to the circumstances mentioned in Sec. 2.205(f)(1), 
notice in the form prescribed by Sec. 2.205(f)(2) shall be furnished to 
each affected business whenever information is found to be entitled to 
confidential treatment under section 408(f) of the Act but not otherwise 
entitled to confidential treatment. With respect to such cases, the 
following sentences shall be 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 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 and to obtain preliminary 
injunctive relief against disclosure; provided, that the information 
will not be made available to the public for so long as it is entitled 
to confidential treatment under section 408(f) of the Federal Food, Drug 
and Cosmetic Act, 21 U.S.C. 346a(f)."; and
    (3) Notwithstanding Sec. 2.205(g), the 31 calendar day period 
prescribed by Sec. 2.205(f)(2), as modified by paragraph (f)(2) of this 
section, shall not be shortened without the consent of the business.
    (g) [Reserved]
    (h) Substantive criteria for use in confidentiality determinations. 
Section 2.208 does not apply to information to which this section 
applies. Such information shall be determined to be entitled to 
confidential treatment for so long as this section continues to apply to 
it.
    (i) Disclosure in special circumstances. (1) Section 2.209 applies 
to information to which this section applies. In addition, under Section 
408(f) of the Act, 21 U.S.C. 346a(f), EPA is authorized to disclose the 
information to other persons. Such authority under section 408(f) of the 
Act may be exercised only in accordance with paragraph (i)(2) or (i)(3) 
of this section.
    (2) 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, with the Federal 
Insecticide, Fungicide, and Rodenticide Act, as amended, or regulations 
which implement either such 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 procedures and requirements of Sec. 2.301(h)(2) (ii)
through (iv).
    (3) Information to which this section applies may be disclosed by 
EPA to an advisory committee in accordance with section 408(d) of the 
Act, 21 U.S.C. 346a(d).
[41 FR 36902, Sept. 1, 1976, as amended at 43 FR 40005, Sept. 8, 1978]

 


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