[Code of Federal Regulations]
[Title 40, Volume 21]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR154.15]
[Page 46-48]
TITLE 40--PROTECTION OF ENVIRONMENT
CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
PART 154--SPECIAL REVIEW PROCEDURES--Table of Contents
Subpart A--General Provisions
Sec. 154.15 Docket for the Special Review.
(a) Establishment of the docket. When the Agency first notifies
registrants privately that it is considering issuance of a Notice of
Special Review for a pesticide, it shall establish a docket concerning
that particular pesticide.
(b) Contents of the docket. For each pre-Special Review or Special
Review, the docket shall contain:
(1) The Notice of Special Review, any Notice of Preliminary
Determination, and any Notice of Final Determination.
(2) Any notice issued under Sec. 154.21 or Sec. 154.23.
(3) Any documents (other than information claimed to be confidential
business information) referred to by the Agency in those notices as
relied upon by the Agency in reaching its determination.
(4) Copies of all written comments or materials (other than
information
[[Page 47]]
claimed to be confidential business information) responding to any
notice furnished under Sec. 154.21 or Sec. 154.23 or submitted at any
time during the Special Review process by any person outside of
government.
(5) Any written response to the Notice of Preliminary Determination
from the Secretary of Agriculture or the Scientific Advisory Panel.
(6) A transcript of all public meetings held by the Scientific
Advisory Panel or conducted by the Agency for the purpose of gathering
information.
(7) A memorandum describing each meeting between Agency personnel
and any person or party outside of government which concerns a pending
pre-Special Review or Special Review decision. Each such memorandum
shall be based on notes taken at the meeting and shall specify the date
and time of the meeting, the participants and their affiliations, who
requested the meeting, the subject matter of the meeting, and the person
who prepared the memorandum. Except for information claimed to be
confidential business information, each memorandum shall describe fully
and accurately all significant positions taken, arguments made, and
facts presented by each participant in the meeting, and shall identify
all documents, proposals, or other materials distributed or exchanged at
the meeting. Any discussion of claimed confidential business information
shall be identified in meeting notes and referenced in the memorandum.
(8) All comments, correspondence, or other materials concerning a
pending pre-Special Review or Special Review decision provided to the
Agency by a person or party outside of government (other than
information claimed to be confidential business information).
(9) All documents, proposals, or other materials concerning a
pending pre-Special Review or Special Review decision, provided by the
Agency to any person or party outside of government (other than
information claimed to be confidential business information).
(c) Assertion of confidential business information claims. (1)
Information, comments, data, or other written material submitted to the
Agency concerning a Special Review may be claimed by the submitter to be
confidential business information. The burden of identifying claimed
confidential business information rests with the submitter, or, in
meetings, with the participants who wish to assert a claim of
confidentiality.
(2) To assert a claim of confidentiality for all or any part of a
written submission concerning a Special Review, the submitter must
furnish three copies of the material. Two copies must be complete, with
claimed confidential business information clearly marked in the text.
Items in the document that are claimed confidential should be numbered
consecutively throughout the text. The third copy must have the claimed
confidential business information excised from the text without closing
up or paraphrasing the remaining text. The deletions should be
consecutively numbered to correspond to the numbering of the complete
copies. Each copy must be marked on the cover as to whether it contains
claimed confidential business information.
(3) Any written material concerning a Special Review received by the
Agency that is not marked as confidential will be deemed to be
nonconfidential, and may be made available through the public docket or
otherwise disclosed without prior notice to the submitter.
(d) Placement of materials in the docket. Any memorandum identified
under paragraph (b)(7) of this section shall be placed in the docket
within 10 working days of the subject meeting. Materials identified
under paragraph (b)(8) of this section shall be placed in the docket
within 10 working days of receipt by the Office of Pesticide Programs,
or within 15 working days of receipt by the Office of Pesticide Programs
if the submitter has asserted a confidential business information claim
concerning the submittal. Materials identified under paragraph (b)(9) of
this section shall be placed in the docket within 15 working days of
transmittal to such person or party outside of government.
(e) Index. The Agency shall prepare and maintain a current index of
all materials included in the docket. The index will include a list
identifying, for each meeting between Agency personnel and a person or
party outside of government for which a memorandum
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has been prepared, the date, the subject, participants, and person who
requested the meeting. The index will also list any document included in
the docket by its title, its source, its recipient, and the date it was
received or provided by the Agency.
(f) Access to the docket. (1)(i) For each chemical in Special
Review, the docket shall be available for public inspection and copying
and its index kept current and made available to the public on request.
The docket and index for any pesticide for which the Agency has issued a
pre-Special Review notification under Sec. 154.21 will only be made
available for public inspection and copying following issuance of a
proposed decision not to start a Special Review under Sec. 154.23, a
Notice of Special Review under Sec. 154.25(c), or as otherwise specified
in Sec. 154.34.
(ii) The docket and index will be available at the Program
Management and Support Division, in Rm. 236, CM2, 1921
Jefferson Davis Highway, Arlington, VA, from 8 a.m. to 4 p.m. Monday
through Friday, excluding legal holidays.
(2) Information contained in the docket shall not be disclosed to
the public to the extent that FIFRA or any other statute or regulation
(including, but not limited to, 5 U.S.C. 552(b)(3) or (4)) prohibits its
disclosure.
(3) The Agency will distribute a compendium of indices for new
materials in the public docket by mail, on a monthly basis, to those
members of the public who have specifically requested such material. The
Agency will announce the availability of docket indices both annually in
the Federal Register and in each Federal Register Notice concerning pre-
Special Review or Special Review for specific pesticides. The Agency may
also periodically require parties on the mailing list to renew their
previous request for such materials.