Environmental Protection
Agency
Pesticide Programs
Washington, DC 20460
FIFRA Confidential
Business Information
Security Manual
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FIFRA Confidential
Business Information
Security Manual
Revised April 24, 1981
U.S. ENVIRONMENTAL PROTECTION AGENCY
Office of Pesticide Programs (TS-757C)
Washington, D.C. 20460
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OPP SECURITY MANUAL
TABLE OF CONTENTS
SECTION I.
SECTION II.
SECTION III.
SECTION IV.
SECTION VI.
INTRODUCTION
SCOPE AND DEFINITIONS
1. Documents Covered by this Manual
2. Definitions
RESPONSIBILITIES
1. Division Directors
2. Document Control Officers
3. Document Control Assistants
4. Second Line Supervisors
5. First Line Supervisors
6. Individuals
7. Office of the Inspector General
PHYSICAL SECURITY
1. General Rules
2. Access to CBI Documents
3. Safeguards During Individual Use of CBI
SECTION V. COPYING AND DESTRUCTION
1. Policy on Making Copies of Confidential
Documents
2. CBI Copying Facility
3. Authorized Document Users
4. Procedures for Reviewing and Copying
CBI Documents
5. Destruction Policy
6. Precautions Against Unauthorized Disposal,
Salvage, or Copying
TRANSFER OF CBI MATERIALS
1. Between OPP Divisions
2. From OPP to OPTS
3. From OPP to Other Parts of EPA and
Other Federal Agencies
4. From OPP to Higher Governmental Units
5. From OPP to a Contractor, Subcontractor
or Consultant
6. Telecommunications
7. Meetings Involving Discussion of CBI
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SECTION VII. COMPUTER SECURITY
1. The Resource Access Control Facility
2. Encryption of Data Files
3. Physical Security
SECTION VIII. CBI TYPING PROCEDURES
1. Documents Typed Internally
2. Documents Typed on Contract
SECTION IX.
DIVISION SECURITY PROCEDURES
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APPENDICES
Appendix A.
Appendix B.
Appendix C.
Appendix D.
Appendix E.
Appendix F.
Appendix G.
Appendix H.
Appendix I.
Appendix J.
Access Authorization Forms and Confidentiality
Agreements
Conference Proceedings Forms
CBI Cover Sheets
User Sign Out Log
Sample Transmittal Forms
Request for Copying CBI material
Destruction Approval Form
Document Control Officer (DCOs) and
Document Control Assistants
Interagency Memorandum of Agreement
(for transfer of CBI)
Persons Authorized to Request CBI Materials from OPP
Document Center
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SECTION I
INTRODUCTION
Confidential Business Information (CBI) is;
"any information in any form received by EPA from any person, firm,
partnership, corporation, association, or local, state, or Federal agency
which contains trade secrets, formula, commercial or financial information,
and which has been claimed as confidential by the person submitting it and
which has not been legally determined to be non-confidential by the EPA
General Counsel under the procedures in 40 CFR Part 3, Subpart B".
[NOTE, at present all non-published data received from a registrant under
FIFRA by OPP will be considered as CBI and treated as such.]
While FIFRA establishes the need and basis for the Agency to receive and
use this information for official purposes; it also provides that CBI is
entitled to protection from unauthorized release, and specifies penalties
that can be imposed upon employees who are found to be responsible for
disclosure of this information to unauthorized persons.
As employees of the Office of Pesticide Programs, you handle thousands of
documents that contain CBI in connection with your official duties.
Because your handling of these documents is complicated by needs to provide
temporary storage, secure routing, judicious copying, and careful
accountability for so many documents, we have prepared a manual of
procedures that provides a reasonable amount of discipline and uniformity
for these activities.
This Security manual is intended to prescribe uniform standards that will
be met within OPP to guard against inadvertent release of CBI to
unauthorized persons. We have also provided for the development and use of
specific procedures by the Divisions to meet their specific needs, with the
understanding that these procedures must meet the OPP standards. As an
incentive for compliance, various disciplinary measures are provided for
should these procedures be neglected. Much more strict penalties may of
course be imposed for willful violations that result in the compromise of
CBI. Your attention is directed to the section on scope and definitions
for a discussion of the various types of documents and the treatment to be
afforded to each.
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This Security manual was prepared by a task force of representatives from
all OPP divisions. It provides for document handling and other needs that
are unique to OPP, while incorporating some features of the TSCA Security
Manual. It contains guidelines for handling Confidential Business
Information on the work site during routine business operations, and for
routing CBI between official users. Safe storage facilities, procedures
for copying and contract typing, document accountability and release,
computer security, and designation of special program officials and their
responsibilities are included. This manual is intended to be an updatable
reference, and will be changed as needed.
As persons who are given access to these documents, you are expected to
exercise care in handling them. This manual is a guide, but can only help
afford the protection described in FIFRA. Your good faith efforts are the
key. I urge you to study this security manual and the procedures that are
specific to your division, and to work closely with your colleagues and
designated officials to make this program work.
Edwin L. Johnson
Deputy Assistant Administrator
for Pesticides Programs
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SECTION II
SCOPE AND DEFINITIONS
This manual specifies certain standards and procedures that deal with
protecting documents that contain CBI from inadvertent release to
unauthorized persons. These types of documents are described below. In
certain circumstances, documents (or parts thereof) that are normally
afforded protection may be released. Specific criteria and procedures for
establishing the releasability of documents are covered in a companion
document (OPP Document Release Policy) which will be published separately.
While the specifics of document release are therefore beyond the scope of
this manual, a general observation is appropriate here: that decisions to
release documents often involve review by the ISB FOI staff, Division staffs
and Directors, the DAA, and OGC. Individuals are therefore cautioned
against making any unilateral determinations to release the documents
described below.
1. Documents Covered by this Manual
A. Documents that contain information specifically protected by
statute (FIFRA Section 10(d)(1) and (2)) must not be released,
except as provided for by Section 10. These documents are
classified as CBI because they contain confidential statements of
formula, manufacturing process, and quality control information,
testing methods to identify inert ingredients, or production data.
B. Documents that contain safety and efficacy data ("Company Data"
is the term used in OPP) that are submitted by registrants must
be protected from release until such time as current court suits
are resolved and the releasability of this data thereby finally
determined.
C. Documents received by OPP from other organizations (associations,
federal, state, or local agencies) who claim they contain CBI,
must be protected from release.
D. Documents developed by OPP or its contractors must be protected
from release until a determination is made that referenced or
contained CBI has been removed.
E. Documents that are developed in OPP to express scientific or
regulatory positions must be protected from release until a
determination is made on their releasability.
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2. Definitions
A. Access; the ability and opportunity to gain knowledge of
Confidential Business Information in any manner whatsoever.
B. Archives; any collection of information held in common by an
organizational group, i.e./ data files under the care of any
branch, section, division, etc.
C. Archiving; maintaining a set of records or data.
D. Authority; The Federal Insecticide, Fungicide and Rodenticide
Act (FIFRA), as amended in 1978, provides in Section 7(d) and
Section 10 that material may be entitled to treatment as trade
secret or proprietary data. Section 12(a)(2)(D) makes it
unlawful for any employee to use to his own advantage or to
reveal any confidential information (except to persons needing
the information for the performance of official duties). Section
10(f) makes it unlawful for any employee to disclose confidential
information except as authorized by Section 7 and 10.
E. Authorized Computer Facility! any EPA or contractor computer
facility which has been approved in accordance with OPP
procedures for processing and/or retaining Confidential Business
Information.
F. Authorized Person; an Authorized Person is one who has:
(1) Been certified by the Division Director (or equivalent) that
CBI is required in the performance of official duties. This
is accomplished by their signing and dating Section I of the
"Access Authorization for FIFRA Confidential Business
Information" form. (See Appendix A-1.)
(2) Signed and dated the FIFRA Confidentiality Agreement
which is on record with their respective DCO (DCA). This is
accomplished by the employee completing Section II of the
"Access Authorization for FIFRA Confidential Business
Information" form. (See Appendix A-1.)
(3) Had a National Agency check, which is a review of the
files of the Federal Bureau of Investigation (including
fingerprint files), the Office of Personnel Management, the
House Internal Security Committee, and the military
services, or other Government agencies, as appropriate. The
files of the Immigration and Naturalization Service and the
Central Intelligence Agency will be reviewed when the
individual is an alien or a naturalized citizen of the
United States.
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G. Confidential Business Information (CBI)t "any information in
any form received by EPA from any person, firm, partnership,
corporation, association, or local, state, or Federal agency
which contains trade secrets, formula, commercial or financial
information, and which has been claimed as confidential by the
person submitting it and which has not been legally determined to
be non-confidential by the EPA General Counsel under the
procedures in 40 CFR Part 3, Subpart B." [Mote: at present all
non-published data received from a registrant under FIFRA by OPP
will be considered as CBI and treated as such.]
H. Contractor or Subcontractor; any person, association,
partnership, corporation, firm, educational institution,
governmental body, or other entity performing work for EPA under
a contract or subcontract with EPA.
I. Data; technical information submitted by registrants and
others under FIFRA.
J. Disciplinary Action; failure to conform to provisions of
this manual may result in disciplinary action as described in the
EPA Conduct and Discipline Manual (chapter 5 and appendix C,
Table of Offenses and Penalties, 35(B).
K. Documents; any recorded information regardless of its physical
form or characteristics, including, written or printed material;
data processing card decks, printouts, and tapes; maps, charts,
drawings, working notes and papers; reproductions of such things
by any means or process; and sound, voice or electronic
recordings. Usually refers to items of technical data (either
volumes or studies) with a unique (accession) number in the OPP
archive.
L' Employee; any person employed by the Environmental Protection
Agency on a full or part time basis. This definition does not
include contractors, grantees, or their employees.
M. Information; knowledge which can be communicated by any means.
N> Penalties; may be levied for violating certain provisions of
the law as follows:
FIFRA Section 12(a)(2)(D) makes it unlawful for any employee to
use to his own advantage or to reveal any confidential
information to unauthorized persons. Conviction of violating
this section may result in penalties up to a $10,000 fine and 3
years in prison.
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FIFRA Section 10(f) makes it unlawful for any employee to
disclose confidential information except as authorized by
Sections 7 and 10. Conviction of violating this section may
result in penalties up to a $10,000 fine and 1 year in prison.
0. Secure Facility, Storage Room, or Area; any building or
portion thereof which has been inspected and approved prior to
use by the Security and Inspection Division, EPA, for the
handling of FIFRA Confidential Business Information materials.
This includes door locks (either changeable combinations and/or
key locks) and ultrasonic devices to monitor entry during non-
working hours.
P. Violations; It will be considered a security violation any
time the guidelines in this manual are not followed, whether or
not an unauthorized disclosure takes place. Violations will
result in disciplinary action, which may include penalties.
Q. Volumes; any physical collection of data; especially the form
submitted by the pesticide companies for consideration under
FIFRA.
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SECTION III
RESPONSIBILITIES
1. Division Directors are responsible for the protection of
Confidential Business Information and the prevention of unauthorized
access or release, while held within his/her division, as well as:
A. Approving the "Access Authorization for FIFRA Confidential
Business Information" form (for all employees in the division
needing CBI access) by completing Section I of the form. (See
Appendix A-1.)
B. Reviewing reports of security violations that come from
supervisors and DCO (DCA) personnel, taking appropriate
disciplinary action, and referring them to the Inspector
General's Office if CBI has been compromised. Copies of all
violation reports will be sent to the Inspector General's Office.
C. Delegating any of the following responsibilities (in writing)
under these rules to a designated representative (the Document
Control Officer (DCO), so that the day to day administration of
the security procedures is assured.
D. Obtaining the signature, EPA ID number, and employment date of
the employee in Section II of the form entitled "Confidentiality
Agreement for EPA Employees." (See Appendix A-1.)
E. Forwarding a copy of the forms mentioned previously to the
Division Document Control Officer (DCO) or Document Control
; isistant (DCA) for retention. (See the next subsection for
other duties of DCO's/DCA's.)
F. Appointing DCO(s) and DCA(s) for his/her division, including the
forwarding of the necessary signed forms (Appendix A) to the
Security Branch of EPA (with a copy to the Office of the DAA).
(1) DCO's shall have a minimum of: 1 year experience with OPP,
be a GS 11, or higher, and have no financial conflict of
interest as checked by the DAA.
(2) DCA's shall be a minimum of a GS 4 clerical and have no
financial conflict of interest as checked by the DAA.
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G. Establishing Division specific CBI handling procedures, tracking
methods/ and secure areas within the division.
H. Assuring that a procedure exists whereby any employee terminating
or transferring to a position not requiring access to FIFRA CBI
is referred to a DCO prior to such action so that a Terminating
Confidential Agreement can be obtained by the DCO. (See Appendix
A-2.)
2. Document Control Officers (DCO's) are the focal point of the security
system and are vital to the success to the system. They are
responsible for:
A. Obtaining and forwarding to the Division Director (with a copy
to the DAA for a check against Conflict of Interest forms) once
the Access Authorization is approved, a copy of the SF-171 for
any employee whose appointment falls within the following
categories:
(1) Per diem, intermittent, temporary or seasonal employees when
the appointments are specifically limited to three months or
less.
(2) Clerical employees similar to stenographer, typist, or law
clerk, for four months or less as summer temporaries.
(3) Experts and consultants employed on an intermittent basis
when the appointment is limited to one year or less.
(4) Appointments limited to 700 hours or less.
B. Speaking for the Division Director in matters of CBI security, as
delegated by the Division Director in writing.
C. Maintaining copies of all necessary forms used in these
procedures as well as filing completed forms for future
reference.
D. Producing needed procedures (for use within a division) that add
needed detail to those outlined in this manual and distributing
them to all appropriate staff members. Such procedures may not
conflict with the basic provisions of this manual.
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E. Establishing either a tracking system within his/her division or
a secure reading area (see definitions: secured area) for
safeguarding CBI materials. (Lacking a secured area that has
been approved by the Security Branch, the tracking system must
meet the same criteria as that met by the division to division
tracking system, discussed in Section VI.)
F. The daily oversight of the security system, as well as occasional
checks of the system such as spot checks for CBI not secured.
G. Communication between his/her division and other divisions in the
matter of CBI security, and communication with the chief DCO in
the Program Support Division.
H. Controlling all secured storage and/or reading areas within his/
her division. (See section on Physical Security.)
I. Permitting access to only those individuals who are "authorized
persons" and maintaining a current list of those persons for his/
her division.
J. Evaluating the present security measures and determining if they
are sufficient to the current needs of the division and OPP.
K. Reporting security violations to the Division Director so that a
review may be made.
L. Conducting and/or arranging any necessary briefings on security.
M. Controlling all movement of CBI into and out of the division, and
assuring that all necessary transmittal forms are signed,
correctly filed and available for inspection. (See Section on
Transmittal of CBI Materials for details.)
N. Ensuring that proper covers are attached to make the CBI
instantly identifiable before these documents leave the control
of the DCO (DCA). (See Appendix C for copies of covers.)
O. Expediting requests for necessary locks and security equipment as
needed, as well as arranging for the changing of locks and
combinations due to the termination or transfer of authorized
persons.
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P. Approving destruction of obsolete CBI in accordance with
records retention schedules. (See Document Management Section,
Information Services Branch, PSD, for details on schedules.)
Q. Submitting and updating the list of CBI copying approval
officials.
R. Approving any individual filing/storage used to hold CBI material
within the division space.
S. Acting as liaison between contractors and the division, Contracts
Management Division and the Security Branch of the Facilities and
Support Services Division and the Inspector General's Office.
T. Delegating portions of his/her authority to designated
representative(s) (Document Control Assistant(s) (DCA) as
approved by his/her Division Director.
3. Document Control Assistants (DCA's) are responsible for:
A. The actual logging of documents to comply with the tracking
system(s).
B. Other duties of the DCO as delegated to them in writing by the
DCO and/or Division Director.
4. Second Line Supervisors (Deputy Division Directors, Branch Chiefs,
etc.) are responsible for:
A. Any responsibilities of the Division Director as assigned, except
the first, since the authorization signature may be given by the
Division Director or the Acting Division Director only. Such
delegation of authority should be in signed memo form and
distributed for inclusion in the manuals held within the
appropriate division.
B. Documenting any security problems for the Division Director and
contacting the appropriate DCO (DCA) for a speedy solution.
5. First Line Supervisors (Section Chiefs, Team Leaders, etc.) are
responsible for:
A. Being familiar with the information contained in this manual.
B. Ensuring the day to day compliance with the rules by the workers
under their supervision and providing positive guidance as
needed.
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C. Ascertaining that the employees have become familiar with the
rules in this manual and that they are being followed on a
regular basis.
D. Encouraging a positive attitude so that the success of these
measures is assured within their work area.
E. Counseling workers not meeting these standards of conduct and/or
reporting violations of security to his/her Supervisor for
referral to the Division Director.
F. Approving in writing the copying of CBI materials.
G. Reflecting proper or improper handling of CBI in the yearly
Performance Appraisal under the current headings of:
Cooperativeness, Judgement and Attitude.
H. Checking that the physical security of his/her work area is
assured either personally at the end of the work day, or
assigning in writing a qualified person for this duty. It must
be possible for a DCO (DCA) to conduct periodic checks on the
security of any given area at the end of the work day and be able
to verify (from a written log, posted memo, etc.) who was
assigned that duty.
6. Individuals (Non-supervisory and non-DCO's) are responsible for:
A. Reading this manual and being familiar with its contents.
B. Following the procedures in this manual and the specific division
procedures that are incorporated herein.
C. Reporting security violations to their supervisor.
7. Office of the Inspector General (OIG)
The OIG is responsible for conducting investigations of cases that
involve the apparent unlawful disclosure of FIFRA Confidential
Business Information and for auditing OPP investigations that have not
been referred to the OIG. The following procedures apply:
A. OIG investigations shall be requested by the DAA, or by a
Division Director through the DAA. A statement of the
circumstances of the subject disclosure shall be provided with
the request.
B. A report of the results of OIG investigations will be provided to
the DAA and to the Department of Justice/ if appropriate.
C. Violations of provisions of this manual will be reviewed by the
appropriate Division Director. A second review will be performed
at the DAA level in cases where personnel are involved in
additional violations and/or when an actual compromise may have
occurred. Copies of Division and DAA level reviews will be
provided to OIG for audit and possible further investigation if
the OIG feels this is necessary.
•
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SECTION IV
PHYSICAL SECURITY
It is the general policy of OPP to use physical measures whenever possible
to safeguard Confidential Business Information. This includes
providing, where possible, for meeting areas away from the working areas of
OPP employees where such working areas cannot provide privacy and other
means of restricting access to CBI documents or information by unauthorized
persons.
1. General Rules
A. All new Confidential Business Information received in the Office
of Pesticide Programs shall be referred to the Process
Coordination Branch of the Registration Division for the
assignment of a unique identification number to allow for
tracking.
B. CBI documents are to be easily identifiable by the use of special
covers, stamps, etc. (See Appendix C-1 to C-3.)
C. Documents are to be stored in approved secured file equipment,
data/mail/correspondence storage rooms, and other approved
secured storage areas.
D. File equipment must be secured by three-way changeable
combination locks as approved by the Security Branch.
E. It is the responsibility of the Supervisor of his/her area to
insure at the close of business that doors in any secured
work area are locked, alarms activated if appropriate and that
CBI documents in unsecured work areas have been placed in secured
storage. This authority may be delegated in writing by the
Division Director to the DCO (DCA).
F. Secured storage cabinets, rooms, etc. will be clearly marked as
such.
2. Access to CBI Documents
A. Authorized EPA employees will obtain all CBI documents incoming
to the division from another division through their Document
Control Officer (DCO) or Document Control Assistant (DCA).
B. The employee will sign for the CBI document (see Log Sheet
Appendix D).
C. If a secure area is designated and an employee needs access to
CBI documents but does not need to remove them from this secure
storage area, access will be obtained by authorized persons from
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the DCO (DCA). A sign-in/sign-out log will be used to verify
names against the authorization list.
D. No documents will be allowed to leave a secure storage area
without following established Divisional procedures as specified
in the individual division-produced additions to this manual.
E. When an employee terminates his/her employment or is reassigned
within the Agency, or when access is no longer required, the
combinations to locks which the employee has had access must be
changed.
F. The Administrative Officer of the division will not sign off an
employee's exit clearance before receiving clearance from the
DCO (DCA) and the OPP Document Center that the employee has
returned all CBI documents which were charged out to him/her, and
obtaining a signed Confidential Termination agreement (see
Appendix A-2).
3. Safeguards During Individual Use of CBI
A. All CBI documents must be handled by authorized personnel only.
B. When unauthorized persons are present, documents must be covered,
turned face down, removed from area or otherwise protected.
C. Each person is responsible for securing any CBI documents in his/
her possession. When persons are reviewing or processing CBI
documents, these documents are considered their responsibility
until properly placed in secured storage or transferred to
another authorized person. During the review and handling
process, persons in possession of these documents are responsible
for protecting or securing these documents before leaving their
work area for any reason.
D. CBI must be stored in approved secure locked files or secured
rooms when not in use and at close of business.
E. Each person must safeguard keys and combinations to files, safes,
rooms, etc. Keys and combinations to CBI files must be retained
in a secured place in the work area and not removed except with
the written approval of the DCO (DCA). Lost keys or suspected
breach of security in respect to combinations must be reported
immediately (no later than COB that working day) to the DCO (DCA)
so that immediate changes can be carried out.
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F. Data of a confidential nature given to any other OPTS employee or
non-OPTS employee for review must be locked in a secure file
(protected by three way changeable combination locks or kept in a
secured area) when not in use as provided for under these
regulations. Employees transferring data to other authorized
persons must inform them that this is a CBI document before
transferring it to them. Data transferred out of the Division
should go only through the DCO (See Section VI for details on
transferring CBI material.)
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SECTION V
COPYING AND DESTRUCTION
1. Policy On Making Copies j>f Confidential Documents
A. Any reproduction of documents containing OPP Confidential
Business Information shall be kept to an absolute minimum.
B. Copies of any part of a CBI document in any form (e.g., paper or
fiche) will be made only at the OPP Document Center, Room 312,
Crystal Mall Building 2). Division copy centers may
be established when copying equipment becomes available.
C. Confidentiality of data in the OPP document system shall be
indicated as follows:
(1) All company data are Confidential Business Information
unless otherwise marked.
(2) All Pesticide Document Management System (PDMS) studies
beginning with the Master Record identification numbers
(MRID) 00 (zero zero) are CBI unless otherwise marked.
(3) All PDMS studies with MRID numbers beginning with 05 (zero
five) are not CBI.
D. Each copy of a CBI document shall be marked with a control number
and its existence and disposition shall be recorded on a document
control record.
E. All hard copy reproduction shall be done on pink paper so as to
readily reflect its CBI classification.
F. Microfiche copies containing CBI shall be produced with a red
stripe in the label area.
G. If copies (including extracts or citations from CBI documents)
are to be sent from one division to another within OPP, or are
sent outside OPP, persons sending such documents are reminded
that they are individually responsible to establish an audit
trail through the Division Document Control Officer (DCO) or
Document Control Assistant (DCA) for the accountability of all
copies (see transfer rules in Section VI).
2. CBI Copying Facility
A. The OPP Document Center is located in rooms 310/312, CM-2. It
serves as the custodian of all company data and pesticide studies
entered into the Pesticide Document Management System (PDMS).
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The document mode is microfiche, from which copies are made by
Document Center personnel only. The center can produce copies:
(1) From paper to paper
(2) From microfiche to paper
(3) From microfiche to microfiche
B. The OPP Document Center is a restricted area, to which only
assigned operating personnel are admitted. All requests will be
presented to the clerk on duty at the entrance, following the
procedures in paragraph 4, below.
3. Authorized Document Users
Division Directors will furnish the OPP Document Center a list of
employees having CBI clearance who are authorized to have access to
Confidential Business Information in the Document Center. Format of
the list should be similar to the example shown as Appendix J.
4. Procedures for Reviewing and Copying CBI Documents
A. To obtain CBI material from the OPP Document Center, the
requestor's name must appear on the access list approved
by his/her division director. The requestor must also present
his/her EPA identification badge prior to receiving any CBI.
B. The OPP Document Center will provide data for quick reference
work at the center or carry-out copies (fiche and/or paper) for
use in the requestor's office. In either case, the requestor
must sign for the data when received. This will be done on a
charge-out record prepared for each recipient of CBI. When a
document is returned to the center, appropriate annotation and
signatures will be made on the record to reflect such return.
Prior to departure from his/her OPP assignment, the recipient of
CBI from the OPP Document Center must return all charged-out
documents or present an acceptable audit trail that will release
him/her from accountability.
C. Release of CBI to non-OPP and other Federal agency personnel will
be in accordance with the provisions of Section VI of this
manual.
D. A registrant's request to review or obtain a copy of his
previously submitted data will be honored only upon
presentation of acceptable credentials and approval by the
Program Support Division's Document Control Officer.
If the request involves copy work, the DCO will coordinate the
transaction with the Information Sources Section of the
Information Services Branch, Program Support Division, so that
the cost of reproduction can be collected.
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5. Destruction Policy
Destruction of FIFRA Confidential Business Information shall be in
accordance with the following:
A. Destruction shall be performed by a Document Control Officer or a
Document Control Assistant under the DCO's supervision. A
record of CBI destruction shall be maintained by each DCO.
B. CBI material that was obtained from the OPP Document Center shall
be returned to the center for disposition when the OPP recipient
has no further need for it. Destruction will be accomplished by
the Program Support Division's Document Control Officer.
C. CBI material that was not obtained from the OPP Document Center
shall be destroyed by the DCO of the office or Division having
custody of such material. This includes but is not limited to
printed materials, micrographic images and typewriter ribbons.
D. Destruction of CBI on film and paper stock shall be accomplished
by processing the material through the Paper Pulverizer located
in a secured area at Waterside Mall. CBI stored on magnetic
materials shall be destroyed by degaussing or with an overwrite
program as authorized and supervised by the appropriate DCO.
6. Precautions Against Unauthorized Disposal, Salvage, or Copying
Division DCO's and DCA's shall be responsible for instructing all
persons cleared for access to CBI against unauthorized disposal and
copying. Bad copies or brief extracts from CBI materials are not to
be placed in salvage such as "Use it Again, Sam" boxes. Copying of
CBI materials is strictly prohibited in any form except when
accomplished in the OPP Document Center.
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SECTIOH VI
TRANSFER OF CBI MATERIALS
1. Between OPP Divisions
A. All data leaving a Division must be logged out by the DCO (DCA)
using the prescribed form (See Appendix D). The unique control
number(s) assigned by the Process Coordination Branch, Registra-
tion Division and the transaction date will be entered on the log
by the DCO (DCA).
B. CBI transfers shall require the use of a cover sheet and receipt
form as follows:
(1) A CBI cover sheet stating that the material is CBI will be
affixed to the document or, if covers are unavailable, the
standard stamp of red ink will be used on the cover. (See
Appendix C-1 to C-3.)
(2) A receipt form (See Appendix E-2) will be attached to the
package and a copy shall be pulled and properly filed for
future reference.
C. No documents containing CBI will be transferred from one division
to another without going through one DCO (DCA) to the other
Division's DCO (DCA).
D. All incoming CBI will be processed by the DCO (DCA) so that every
document containing CBI will be the responsibility of that DCO
(DCA) until transferred to an authorized person. That person
will be accountable for that document until it has been
transferred, in accordance with prescribed procedures, to another
authorized person.
E. No CBI will be received by a division DCO without going through
the proper procedures for archiving incoming data including the
use of the following log-in procedure. (The procedure prescribed
by this manual is designed for secured areas only—divisions
without a secured area will produce a written tracking procedure
for use within their division.)
(1) Each document is received by the DCO (DCA) and is entered in
the log (Appendix D) using the previously assigned document
control number and recording the date of the transaction.
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(2) If CBI cover sheets are not attached, they are affixed at
this time or failing their availability, the cover of the
documents are stamped in red ink with the statement
"Confidential Business Information. Does not contain
National Security Information (E.O. 12065)."
(3) Documents are then filed in secured file cabinets.
F. If documents are to be signed out to a person in an open work
area rather than kept in a secured area, they must be logged out
by the DCO (OCA) and then signed for by the person that will have
physical possession of the documents, using the procedures
outlined in the division-produced tracking system and stored in
an approved storage cabinet with proper locks, etc., when not in
use. It is up to each Division to determine whether its CBI
documents will be controlled in a secure area or by individual
employees in prescribed filing equipment.
G. The transmittal form must be signed by the receiving DCO (DCA)
and returned to the transmitting DCO (DCA) for retention and
clearing of the tracking records. (See Appendix E-2).
2. From OPP to OPTS
All CBI documents leaving OPP to other parts of the Office of
Pesticides and Toxic Substances (OPTS) will go through an OPP DCO
(DCA) to the appropriate DCO (DCA) in OPTS with the transfer documents
used by OPP for interdivisional transfer of documents. (See Appendix
D, and E-2).
3. From OPP to Other Parts of EPA and Other_ Federal Agencies
A. Transfer of CBI to other federal agencies shall be preceded by
the establishment of an interagency memorandum of agreement.
(See Appendix I)
B. All CBI documents leaving OPP to other Federal components shall
proceed through the division DCO, wih the approval of the
Division Director, and be entered into the appropriate tracking
system.
C. Anyone receiving the CBI material shall sign the proper transfer
form (Appendix E-2) and be informed by the DCO of the proper
physical security measures that should be taken to safeguard that
material.
4. From OPP to High Governmental Units
Material requested by a Congressional Committee, the Office of the
President, GAO and any foreign govenment shall be sent by the
appropriate DCO (DCA) to the Office of the Deputy Assistant
Administrator for the Office of Pesticide Programs (External Affairs
Unit). All material containing CBI will proceed to Congress through
that office and no other.
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5. From OPP to a Contractor, Subcontractor or Consultant
A. No confidential business information shall be disclosed to a
contractor unless all of the following conditions are met.
(1) The contract must authorize the disclosure of CBI to the
Contractor, and the Contractor must have agreed to the
clause entitled "Treatment of Confidential Business
Information" before receiving such information.
(2) The contractor's security plan and facility requirements
for safeguarding Confidential Business Information must be
approved by the Program Project Officer and the OPP Security
Officer before any CBI is disclosed to the Contractor.
(3) A notice that CBI is to be disclosed to the Contractor must
be published in the Federal Register in accordance with 40
CFR 2.301(h)(2)(iii) and the prescribed waiting period must
be adhered to before such disclosure is made. The OPP
office managing the contract shall provide the Information
Services Branch, Program Support Division with the
information needed for the Federal Register notice.
B. Transfer procedures for Documents containing Confidential
Business Information to Contractors, Subcontractors, or
Consultants.
(1) The (Contract) Project Officer responsible for the contract
or subcontract shall request the necessary CBI from the
appropriate DCO (DCA). This written request shall include
the identity of the contractor or subcontract and the number
of the contract or subcontract.
(2) Upon receipt of such a request the DCO (DCA) shall provide
the requested CBI to the (Contract) Project Officer in
accordance with the procedures prescribed earlier in this
section for transferring documents from one division to
another or in accordance with the division procedures for
transfer within a division.
(3) The (Contract) Project Officer shall furnish the CBI to the
contractor or subcontractor in accordance with the
procedures as described earlier in this section for transfer
from one OPP division to another.
(4) The (Contract) Project Officer shall obtain a written
receipt for the CBI from the contractor or subcontractor and
send it to the appropriate DCO (DCA) who shall enter it in
the log. (Appendix E-2).
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6. Telecoinmuni cat ions
With the permission of a Division Director or the data submitter,
FIFRA CBI can be transmitted electronically through telecopier
lines to secure areas within EPA or to the data submitter whose
material is involved. The telecopier will be used for such
transmission only by authorized EPA personnel who will ensure
that no unauthorized person can see or otherwise gain access to
the CBI being received or transmitted.
7. Meetings Involving Discussion of CBI
For any meeting, symposium, panel discussion, or seminar at which
FIFRA CBI will be discussed, the meeting chairperson shall provide a
FIFRA CBI Sign-In Sheet (Appendix B-1, B-2) if there are attendees who
have not had prior access to the CBI to be discussed. In addition,
the chairperson will retain the option to require a sign-in sheet
whenever he/she thinks it necessary. All attendees must sign it and
record their EPA identification badge number. The chairperson shall
give the sign-in sheet to the local DCO/DCA who will retain it for 1
year.
The chairperson must also ensure that only authorized persons are
present and shall announce FIFRA CBI is to be discussed. When
necessary, the chairperson shall review with the attendees their
responsibility for safeguarding CBI in any and all forms, including,
but not limited to, any notes taken and any subsequent discussions.
No recording is to be made of the meeting unless the chairperson has
authorized it. If authorized, the recording must be treated as all
other confidential business information and entered into the document
control system.
The meeting room shall be secured after the meeting by the
chairperson. This includes cleaning all chalkboards, destroying, by
approved methods, all tear sheets and other notes, and ensuring that
nothing is left in the room that could lead to the unauthorized
disclosure of FIFRA CBI.
When notes containing FIFRA CBI are taken from a document, a meeting,
or anyother source, the notes must be protected as CBI. If the notes
are to be circulated to other authorized persons, they must be entered
into the document control system. The taking of notes is discouraged
and should be kept to a practical minimum. Any document generated
from notes shall be treated as described in Section IV of this manual.
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SECTION VII
COMPUTER SECURITY
The Resource Access Control Facility (RACF) is maintained by the
contractor at Research Triangle Park, N.C., for use by EPA. RACF uses
a series of profile tables/ which contain descriptions of users,
groups of users, and data resources, to check access authorization.
These include:
A. User Profiles containing attributes that define the user's
authority to access data resources and issue RACF commands.
B. Group Profiles containing a list of the members in the group and
the authorities of each member.
C. Data Resource Profiles (DRP) containing a list of authorized
users and groups of users and the access authority of each. Also
the DRP contains the universal access authority (UACC) to be
granted to users who are not specifically granted or denied
access.
D. Authorization checking is the basis for deciding whether a
processing function or an access to protected resources should be
allowed or prevented. RACF performs authority checking without
any user or operator intervention. If the access is authorized,
it is allowed; if unauthorized, it is denied.
E. The Data Administrator (PSD) can, at any time, change any of the
authorization parameters.
Encryption of Data Files will be performed on computer records
pertaining to production data volumes reported by registrants/
manufacturers. These data files will be maintained at Research
Triangle Park in an encrypted mode so that any unauthorized user
cannot obtain volume information. The data records will be decoded
for processing of a retrieval request. All temporary data sets will
be purged upon completion of the processing run.
Physical Security of the OPP computer room is protected by double
locks on both access doors in non-prime shift hours. Prime shift
security is maintained by a minimum of two computer operators
physically in the room. Jobs security/logging uses the following
technique:
A. When a job is printed, the operator removes it from the printer.
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B. The operator then logs it in using a Data 100 CRT which creates a
permanent computer file containing information about the account,
initials, lines of print, job number, time of day, cost and other
job parameters.
C. The operator then places the non CBI printout in that user's bin
and the user picks up the materials.
D. CBI jobs shall be under a unique account name that indicates that
the printout contains protected material.
E. The operator shall intercept the jobs containing CBI and call
the DCO (DCA). These printouts will not go into the user's bin
for pickup.
F. The DCO (DCA) shall pick up the hard copy (printouts) from the
operator and lock them in a secure cabinet until the authorized
official claims them by signing the official log which includes
the job number and date. (See Appendix D).
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SECTION VIII
CBI TYPING PROCEDURES
Documents Typed Internally
Each division is instructed to produce procedures for the protection
of draft material containing CBI and the protection of such drafts and
ribbons held within a division which include:
A. The responsibility of the drafter of a document to put a CBI
cover sheet on material to be typed so that all who handle it are
aware it is to be protected.
B. Assigning the typing of such a draft to authorized typists only.
C. The locking in a secured cabinet or room; the handwritten draft,
incomplete or undelivered typed versions of the draft, and the
ribbon or disc used to produce the document.
D. The return of all materials used to produce the CBI containing
document to the drafter.
E. The destruction (See Section IV) of all the draft copies and the
ribbon/disc used for their production.
Documents Typed on Contract
Procedures for transferring draft CBI material to the contractor for
typing are indicated below.
A. Drafters of CBI material are to place a red cover sheet over the
CBI rough draft material.
B. Place the draft inside two envelopes before hand carrying
document to DCO (DCA) for transmittal to the contractor.
C. The inner envelope should be addressed to the contractor and
have "CONFIDENTIAL BUSINESS INFORMATION" stamped or printed on
the envelope, and the phrase "TO BE OPENED BY ADDRESSEE ONLY"
printed or stamped on the envelope.
D. The outer envelope should be a regular envelope (not an
interoffice envelope) and have the recipient's full mailing
address on it. There should be nothing written on outside
indicating that CBI material is contained in it.
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E. The drafter will attach to the outside of the double envelope a
correctly completed EPA Request for Typing/Editing Form (EPA Form
7710-9), with "CONFIDENTIAL BUSINESS INFORMATION" printed or
typed and underlined in the comments section, Block 20 of the
form (see Appendix E-1).
F. The drafter will ensure that the CBI document is hand carried to
the DCO (DCA) and ensure that the drafter/secretary signs the
Confidential Document Control Log transferring control
responsibility over to the DCO (DCA). (See Appendix D).
G. The DCO sends the draft to the contractor for typing.
H. The DCO (DCA) will ensure that the Branch (drafter/secretary)
hand carries the draft document back to the Branch once the CBI
document is returned to the DCO (DCA) and signs the Confidential
Business Information Control Log transferring control
responsibility back to the drafter. (See Appendix D).
I. The DCO (DCA)will monitor the flow of CBI rough draft materials
between the EPA and the contractor as outlined below:
(1) Ensure that the outer envelope of the double-envelope
confidential package is addressed to the contractor.
(2) Ensure that a receipt form (see Appendix E-2) identifying
the document is inserted into the inner envelope. (This
receipt form is signed by the contractor security officer
and returned to the Division DCO (DCA) acknowledging
receipt. The receipts will be maintained by the DCO (or
DCA) until the typed document is received from the
contractor.
(3) Ensure that the CBI document is assigned an OPP CBI control
number and that this control number is added to the bottom
right hand corner of the EPA Form 7710-9 (Appendix E-1).
(4) Ensure that the necessary control copy (yellow, (Contract
Project Officer's copy) of EPA Form 7710-9 has been pulled
and the form has been properly completed including the
addition of "Confidential Business Information" to the
comments section. (See Appendix E-1).
(5) Ensure that the contractor's messenger signs the Confi-
dential Business Information Control Log when picking up and
returning CBI documents, thereby transferring control
responsibility to the Contractor while the document is
being typed. (See Appendix D).
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SECTION IX
DIVISION SECURITY PROCEDURES
Responsibilities of the Division Director, Document Control Officer, Document
Control Assistants, supervisors and individual employees are described in
sections III through VIII of this manual. Those sections give mandatory
procedures to be followed in receiving and logging CBI into the Division,
transferring the CBI material within the division, protection while using the
material, storing, copying, destroying, transferring to another Division, to
other programs in EPA, or to a contractor cleared for handling of CBI.
The Document Control Officer in each division is the focal point of the
security system, having the responsibilities listed in paragraph 2 of section
III. Division DCO's are named below:
Benefits and Field Studies Division
Loa Herbert CM-2, Room 211 557-7244
Hazard Evaluation Division
Ken Condra CM-2, Room 815 557-7347
Program Support Division
Emory Eldredge CM-2, Room 312 557-7151
Registration Division
Edward Gross CM-2, Room 509 557-7123
Special Pesticides Review Division
Jane Babcock CM-2, Room 724-A 557-3043
Procedures for internal security operation within each division are provided
in this section—
Page
Benefits and Field Studies Division .BFSD-1
Hazard Evaluation Division Program Support Division.........HED-1
Program Support Division .PSD-1
Registration Division RD-1
Special Pesticide Review Division SPRD-1
26
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BENEFITS AND FIELD STUDIES DIVISION
SECURITY PROCEDURES
The Benefits and Field Studies Division (BFSD) differs from the Manual by
using the following divisional procedures to track Confidential Business
Information (CBI) documents within the division:
A. Procedures for tracking incoming CBI Data:
The Document Control Officer (DCO) or the Document Control Assistant
(DCA) logs in all CBI data received by or transmitted to the
Designated Security Area in the following manner:
(1) Record document control number in log.
(2) Attach red or white (contractor) cover sheets. If cover sheet
is not available or time does not permit, stamp document in red
ink with statement "Confidential Business Information. Does not
contain National Security Information. (e.o. 12065)." File
document in prescribed cabinets in secured area.
B. Procedures for tracking outgoing CBI Data:
All data leaving a division must be logged out by the DCO or
designated DCA. The DCO or DCA will log out data in the following
manner:
(1) Record control numbers or note date in control log and insure
that the red or white cover sheet or stamp is affixed to the
document.
(2) Insure that the receipt form shown is attached to the package;
the hold copy is pulled and properly filed for future reference;
and that the person transmitting the document signs the control
log.
C. Document Management Responsibilities:
(1) Inventory
The DCO is responsible for inventorying all CBI data held by the
division at least once a year. The DCO will also insure
division procedures by spot checks and by insuring the
availability of proper equipment and locks. The DCO also
directs the disposition of all CBI documents as required by
these procedures.
(2) Employee Clearance when leaving OPP
The Security Division of EPA will not sign off on an employee's
clearance until the Administrative Officer of the responsible
division has signed off. The Administrative Officer of the
division will not sign off on an employee's clearance before
receiving clearance from the DCO (DCA) that the employee has
returned all CBI documents.
BFSD-1
-------
BFSl) Attachment 1
ENVIRONMENTAL PROTECTION AGENCIT
FIFRA CONFIDENTIAL BUSINESS INFORMATION
USER SIGN OUT LOG
(Date/Time
| Checked
I out
|Date
1
|TlM
1
(Data
1
|Tl«e
1
(Date
1
|TlM
1
(Date
I
|Tt««
1
(Data
1
iTime
1
(Data
1
|T1««
1
|0«t«
1
(TIM
1
(Date
1
|T laa
1
(Data
1
iTUie
1
(Date
1
(Tine
1
| Oft Document
Control Number/
Copy Number
'
.
EPA ID
Number
USER IN FORMAT
Last Name
•
CON
Signature
1
1 DCO
Initial
1
Data
Returned
DCO
Initial
1
Date
Destroyed
DCO
Initial
-
Comments
•
-------
BFSD ATTACHMENT 2
MEMORANDUM
SUBJECT: Security of Public Law 92-516 Section 7 Data
FROM :
TO : Recipients of Section 7 Production Data
The attached Section 7 material (Production Data) is provided per your
request. It consists of pages of computer printout. This information
is considered priviledged and it must be severely restricted in its
dissemination, being made available only to those Environmental Protection
Agency officials with valid need for it. Duplication of any of the material
on a copying machine is not authorized.
Unauthorized disclosure of the attached information is punishable by a $10,000
fine or imprisonment of not more than three years, or both. (Section 14 (b)
(3), Public Law 92-516).
Upon completion of your analysis of the information, it should be returned to
Room B-17, East Tower, for subsequent destruction. Until that time you are
personally accountable for the security of the material.
CERTIFICATE
I have read and will abide by the above conditions while the Section 7 data is
in my possession.
Printed Name Signature
Organization Office Telephone Number
Date Returned to SSB Signature
Date Destroyed by SSB Signature
BFSD-3
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HAZARD EVALUATION DIVISION
SECURITY PROCEDURES
1. General Procedures
A. Incoming Data
Confidential Business Information is routinely received in BED
as part of company registration data. Such information normally
comes from one of the following sources: Registration Division
product managers; Program Support Division; Special Pesticide
Review Division; or Benefit and Field Study Division.
The principal source of CBI data is the Registration Division
and such data is normally transported to and from HED Branches
by a designated Personnel Control Clerk* on the HED Director's
Staff. The Division Branches then handle the CBI data in
accordance with the attached descriptive statements.
CBI data transferred to or from approved contractors or other
sources is handled through the DCO. If a question arises/ the
matter is to be referred to the Chief/ Information Services
Branch, Program Support Division.
B. HED Tracking System
(1) Input
a. Material is received by the HED Document Control
Assistant and logged in. Pertinent identifying data
are entered into the log. The documents designating
type of material are appropriately stamped.
b. The material is hand delivered in CBI covers, as
specified by the manual, to the designated cleared HED
staff for study.
c. The material is then shelved in accession number order
in a conserva-file drawer which has combination locks.
(2) Usage of CBI
a. Outside EPA: Material reviewed by other agencies or
by consultants follows the manual procedures.
b. Within EPA: Access to CBI is available to EPA
employees who have been cleared according to FIFRA;
Manual Procedures Division. Material may only be
removed through DCO or DCA by a cleared employee. The
request form is filled out by the requestor. The DCA
prepares two 3X5 cards with borrower's name, etc. One
card is placed in a red plastic cover with a pocket,
*The current designated Pesticide Control Clerk is Marvin Hawkins
HED-1
-------
and placed in numerical order in secured file. The
other 3X5 card is placed numerically in a 3X5 file of
all CBI material. Transmittal of such material
follows procedures as outlined in the FIFRA Manual.
c. Typing: CBI material for typing is hand carried to
the contractor for typing by cleared typist or sent in
double envelopes as specified in the manual.
d. Copying: Only to be done by a secured copier.
e. Destruction of material: A form requesting
destruction is filled out and approved; the material
is then shredded in the designated area.
2. Branch Procedures
A. Ecological Effects Branch
Since RD actions (Sections 3, 5, 18 and 24(c) may contain CBI
materials, these are handled in a guarded manner. Following
delivery to the Branch these are logged in and immediately
assigned to a specific reviewer. Actions may be placed in
Branch holding files until picked up by the assignee.
Reviewers are instructed to place all such materials and copies
of their reviews in secure locations inside locked file cabinets
before leaving work each day .
(1) RD submitted data (some of which may be considered
confidential) is attached with the complete review for
pickup and return to RD via personal carrier. When reviews
are sent to the typing contractor for typing, they are
placed in double envelopes, marked "CONFIDENTIAL BUSINESS
INFORMATION" and "To Be Opened By Addressee Only" — with
the Standard red 8 1/2 x 11" insert which cautions that
some information within may be entitled to treatment as
trade secret or proprietary data under Section 7 (d) and
Section 10 of FIFRA.
(2) Since the Branch also transmits copies of specific reviews
to either the Office of Endangered Species (USFWS/DOI) and
the National Marine Fisheries Service (DOC) in seeking
formal consultations regarding pesticidal effects on
endangered or threatened species, the same red 8 1/2 x 11"
cover described above is attached.
(3) Unpublished studies reviewed during Registration Standard
activities are to be disposed of by shredding, using the
shredder in the llth floor copying room. Data evaluation
records sent to the typing contractor for final typing also
are accompanied by the red 8 1/2 x 11" insert as described
in #1 abovet
RED-2
-------
(4) All Branch personnel have completed the Standard OPP form
"Access Authorization for FIFRA Confidential Business
Information."
(5) In addressing RPAR matters dealing with fish and wildlife
risk assessment/ the Branch receives both published and
unpublished studies. These documents, when confidential,
are kept secure in locked files when not in use. All such
documents are returned to SPRD upon completion of review or
are kept under lock.
B. Environmental Fate Branch
CBI is received by EFB where it undergoes either an in-house
review or is assigned to an EFB contractor for review.
(1) Review Procedures
a. In House
When the data is to be reviewed in-house, it is kept
secured until assigned to a reviewer. The reviewer
evaluates/reviews the data at his/her official work
station, or, under special circumstances, at locations
outside the Agency. If CBI is to be retained
overnight, it is secured in locked Agency files, or
under special circumstances, it is secured by the
reviewer at a location outside the Agency.
b. Contractor Review
EFB also has data reviewed by a contractor. The
contractor, with security clearance, picks up CBI in a
secured van for delivery to the contractor's
location. The contractor evaluates/reviews and stores
the data under secured conditions. Upon completion of
the review, the CBI is returned via secured van where
it is held in secured EFB files. Dissemination is
only to Branches and Divisions within the Agency. The
contractor may retain a copy of the final review it
generated until termination of the contract.
(2) Dissemination
Copies of the reviewer's completed evaluation, with
confidential notation, are disseminated to other Agency
locations via hand delivery, Agency mail or registered mail
with copy retained by EFB. Dissemination outside the
Agency does not occur via EFB directly except under FIFRA,
Section 10 (emergency dealing with protecting against an
unreasonable adverse effect to health or the environment)
or under an FOI request which is sent directly to OGC, if
HED-3
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requested. The CBI, from which the reviewer's evaluation
was generated, is either retained and secured in EFB,
returned to the originating Division or Branch in the
Agency or is destroyed.
C. Health Effects Branch
Health Effects Branch follows the standard HED tracking
procedures.
D. Residue Chemistry Branch
(1) Tracking: All petitions and registration actions are
assumed to be CBI. These documents are received from the
HED Pesticide Control Clerk. They are placed in the RCB
in-box and logged in by the Branch Secretary. The Branch
Secretary routes the material to the appropriate section.
The Section Head keeps the material in a locked file
cabinet until assigned to a reviewer. The reviewer keeps
the material in a locked filing cabinet until the review is
initiated. Once under review the material is kept on the
reviewer's desk during the day and locked in a filing
cabinet at night.
Once the review is completed the material is returned to
the Section Head for secondary review. The Section Head
again keeps the materials in a locked filing cabinet until
the secondary review is completed. At this time the
petition is filed in the Lektrievers, Times II files or
filing cabinets, all of which can be locked.
(2) Filing: Registration Standards data are kept in locked
filing cabinets. Much of the Registration Standards data
are for older chemicals and thus available in the open
literature.
(3) Access: Access to the Branch files during non-work hours
is controlled as follows. All doors to room 810 are locked
each night. All door locks except the main entrance door
cannot be opened except by keys available from the RCB
Branch Chief/Deputy Branch Chief, Division Office or
Guards. The main RCB entrance to room 810 is locked with a
combination lock. The combination lock is available to all
RCB Branch Personnel.
E. Toxicology Branch
(1) Tracking: All registrations and petitions received in TOX
are considered CBI. The Pesticide Control Clerk puts the
action packages in the box for the Environmental Protection
Specialist. This person logs the actions in and places the
unassigned actions in a locked file cabinet. After the
actions are assigned to a reviewer, the reviewer keeps the
actions in a lockable file cabinet. While under active
HED-4
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review the actions are kept on the reviewer's desk during
the day and are placed in a lockable file cabinet at
night. After the review has been completed the whole
package is given to the Section Head for secondary review.
The actions are kept in a lockable file cabinet until
secondary review is complete. The actions then go to the
Registration Coordinator for another secondary review -
again the actions are kept in a lockable file cabinet. The
actions then go to the Branch Chief for final sign-off and
again are kept in a lockable file cabinet. At this time
the registration and petition actions are returned to the
Environmental Protection Specialist where they are logged
out and returned according to manual procedures.
(2) Storing: Data for Registration Standards and RPAR is kept in
lockable file cabinets as much as possible. Much of this data
is available in general literature.
(3) Access: All hall doors into the Toxicology Branch are locked by
both key and combination locks. The keys and the combination
are available to TOX Branch personnel on an "as-needed" basis.
HED-5
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BED Attachment 1
NUMBER
1
CHEMICAL
'
DATE
| RECEIVED
1
1
1
1
1
I
I
1
| TOX. BR.
I CHEN. BR.
I EEB
I RETURNED TO
I
B
.
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HED Attachment 2
Date Out EFB:
To: Product Manager
TS-767
From: Dr. Willa Garner
Chief, Review Section No. 1
Environmental Fate Branch
Attached please find the environmental fate review of:
Reg./File No.:
Chemical:
Type Product:
Product Name:
Company Name:
Submission Purpose:
t;
ZBB Code:
Date In:
Date Completed:
Deferrals To:
ACTION CODE:
EFB #
Ecological Effects Branch
Residue Chemistry Branch
Toxicology Branch
HED-7
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PROGRAM SUPPORT DIVISION SECURITY PROCEDURES
1. INPUT
All CBI received in any element of Program Support Division must be
delivered to the PSD Document Control Officer for entry into the CBI
tracking system.
2. CONTROL
A. The Document Control Officer logs in all CBI for the Division
and its Branches, and transfers CBI to the Document Control
Assistant in each branch of PSD as appropriate. Each branch DCA
maintains the branch tracking system and is responsible for CBI
security in the branch.
B. Most CBI entering the Division is company data from applicants
for registration and is received from the Registration Division
after that division assigns an accession number to the
document. When received in the Document Management Section,
Information Services Branch, the control clerk will add the
accession number to the computer inventory record and will also
make the code entry showing that the document was transferred to
Raven Systems and Research, Inc., for processing into the
Pesticide Document Management System. After updating the
computer record, the control clerk will deliver the CBI document
to Raven personnel in the OPP Document Center. The Raven
recipient will sign a receipt which will be filed in the
Document Management Section for tracking.
C. A record of all CBI received from the contractor as an output
from PDMS processing will be kept in the Document Management
. Section. When such data are transferred to other OPP users, a
signature for each item of CBI material shall be obtained from
the recipient. In most cases, the computer listing which
accompanies the CBI material can be used as the control record
and receipt form.
3. STORAGE AND USE
Microfiche masters of original submissions and PDMS studies are
stored in the OPP Document Center (room 310, Crystal Mall Building
2), and are made available as described in Section V of this manual.
4. TRACKING AND TRANSFERRING
Complete tracking is practiced from accession to transfer or
destruction, as described in Section VI of this manual.
5. DESTRUCTION
Shredding is performed as provided for fiche, paper documents, and
typewriter ribbons. Magnetic recordings may be demagnetized. (See
Section V.)
PSD-1
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6. ACCESS TO COMPUTER STORAGE AND PRINTOUTS
Access to computer storage and production is controlled (see Section
VII).
PSD-2
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REGISTRATION DIVISION SECURITY PROCEDURES
s
Contents
Product Manager Team Security Procedures RD-2
A. New Registrations RD-2
B. Amended Registrations RD-6
C. Tolerance Petitions RD-6
D. Amended Tolerance Petitions .... RD-8
E. RPARs RD-8
F. Congressional Material RD-B
G. Miscellany RD-8
Process Coordination Branch Security Procedures RD-9
A. Coordination Section RD-9
B. Emergency Response Section RD-11
Technical Support Section Security Procedures ......... RD-14
Appendix 1 - Log Form
RD-1
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1. Product Manager Team Security Procedures
A. New Registrations. The following procedures are to be followed
in handling CBI submitted in support of a new registration:
(1) CBI material coming into a Product Manager team from the
Process Coordination Branch (PCB) to support a new
registration action will have on it a CBI red cover sheet
(or if unavailable, the alternate cover specified in
Section VI, IB(2)) identifying it as CBI. Upon receiving
such material, the receiving clerk or other authorized
person will immediately log the jacket in (or see that it
is logged in) and move it to the appropriate reviewer for
review. Should such initial CBI material enter the PM team
directly without going through PCB, the Product Manager
Team OCA shall immediately take it to the Liaison Team in
PCB for processing. If the DCA cannot take it to PCB
immediately, the liaison team DCA in PCB should be
contacted by phone and requested to pick up the CBI. If
the DCA in PCB is not available, the alternate DCA there
should be contacted. If neither of them is available, the
head of the Coordination Section or the next in authority
should be contacted. At no time should CBI be
unnecessarily delayed in moving to PCB.
(2) If in the course of reviewing the submission, the reviewer
finds it necessary to photocopy CBI for transmittal outside
Registration Division, he/she will obtain from his/her DCA
the form entitled REQUEST TO COPY OPTS CONFIDENTIAL
BUSINESS INFORMATION. After filling out the request form,
the reviewer will obtain hisAier Product Manager's
concurrence on the form approving the request. The form
will then be taken by the reviewer, DCA, or other
authorized person on the team to the OPP Confidential
Document Copy Center where the requested number of copies
will be made by the DCA operator in charge. These copies
must be numbered and tracked. (A Product Manager desiring
to photocopy CBI may fill out the same form at the OPP
Confidential Document Copy Center without getting his
supervisor's approval.) When the reviewer is no longer
actively working on the submission, the jacket should be
/ stored in a secured cabinet as specified in Section IV of
this manual or returned to the Registration Division File
Room.
(3) When a reviewer requests a review of a submission
containing CBI from Technical Support Section (TSS), the
reviewer will log out the data on the Data Review Record.
After obtaining a CBI red cover sheet or a substitute as
specified in Section VI, IB(2) from the DCA and affixing it
on top of the CBI-containing material, the reviewer will
then hand carry the material to the DCA or clerk in the TSS
for logging in. (The Herbicide-Fungicide TSS requires that
all CBI material be received by the DCA only.)
RD-2
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(4) When a reviewer requests a review of a submission
containing CBI from the Hazard Evaluation Division (HED),
he/she will:•
a. Log the data out on the Data Review Record form,
including assigning a control number and dating.
b. Obtain from the Product Manager Team DCA a CBI red
cover sheet or if unavailable, use the alternative
specified in Section VI, 1B(2), and the "Receipt of
Confidential Data" form.
c. Attach the cover sheet and the Data Review Record on
top of the data.
d. Give the package to the Product Manager Team DCA to
hand carry to PCS for prioritizing and completion
date, from where it will be sent to HED.
e. When the CBI is returned to PCB, the reviewer, DCA, or
other authorized person on the Product Manager Team
will pick up the material. The DCA will log the
material back in on the Data Review Record form.
f. If the registration is approved:
^. The reviewer will take the jacket to the DCA so
that the DCA can log it out on the Data Review
Record (including assigning a control number and
dating) to the contractor for microfilming and
coding.
2^, The reviewer will indicate clearly on the
"Receipt of Confidential Data" form that the
material is to be microfilmed and coded and that
upon completion of the work, the confidential
material is to be returned to the reviewer by the
contractor.
J3_« The reviewer will insert the jacket in a brown,
gummed envelope with the words CONFIDENTIAL
BUSINESS INFORMATION and TO BE OPENED BY
ADDRESSEE ONLY printed or stamped on the outside,
and seal. If more than one jacket is involved,
the reviewer will use a 12 x 10 x 8 shipping box
ordered through the GSA supply store with just
the contractor's full mailing address on it and
put it at the contractor's pick-up station.
^. The reviewer will place the envelope in a second
brown, gummed envelope with only the contractor's
full mailing address on it and put it at the
contractor's pick-up station.
RD-3
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^. When the jacket(s) is (are) returned from the
contractor, the Product Manager Team OCA will log
it (them) in on the Data Review Record and return
it (them) directly to the RD File Room.
g. If the registration is denied:
_!_. The reviewer will keep the jacket in a secured
cabinet as specified in Section IV, or give the
jacket to the Product Manager Team DCA, who will
hand carry it to the RD File Room.
2. If after the 75-day waiting period, the
registrant withdraws the application, the
reviewer will give the jacket to the Product
Manager Team DCA, who will hand carry it to the
RD File Room.
(5) When a reviewer requests typing of material containing CBI
from a contractor, he/she will:
a. Obtain a CBI red cover sheet or if unavailable, use
the alternate cover specified in Section VI, from the
DCA and place it over the CBI-containing material.
b. Place the material in a brown, gummed envelope
addressed to the contractor with the words
CONFIDENTIAL BUSINESS INFORMATION and TO BE OPENED BY
ADDRESSEE ONLY printed or stamped on the outside. If
the material is too bulky for an envelope, use a 12 x
10 x 8 shipping box with just the contractor's full
mailing address on it.
c. Place the envelope inside a second brown, gummed
envelope with only the contractor's full mailing
address on it.
d. Obtain from the Product Manger Team DCA an EPA Form
7710-9 "Request for Typing/Editing," and after filling
out the form completely, including inserting the words
CONFIDENTIAL BUSINESS INFORMATION (see item 20 in
Appendix E-l of the Security Manual), attach the form
to the outside of the envelope or shipping box.
e. Give the package to the Product Manager Team DCA, who
will retain the yellow control copy from EPA Form
7710-9 and put the package at the contractor's pick-up
station.
f. When the material is returned from the contractor to
the PM team, the DCA will record it on the yellow
control copy from EPA Form 7710-9 and hand the
material to the reviewer or hold it in a security
RD-4
-------
cabinet as specified in Section IV, until such time as
he/she can hand it to the reviewer.
(6) When a reviewer requests microfilming of a change in
labeling and/or confidential formula in a registration
jacket, he/she will:
a. Obtain a CBI red cover sheet (or if unavailable, use
the alternate cover specified in Section VI) and the
receipt form entitled "Receipt of Confidential Data"
from the Product Manager Team DCA. Place the red
cover sheet on top of the confidential data in the
jacket and affix the receipt form to the front of the
jacket*
b. Take the registration jacket to the DCA, who will log
the jacket out on the Microfilm Service
Request/Transmittal form.
c. Indicate clearly on the "Receipt of Confidential Data"
form that the material in the jacket is to be
microfilmed, and that upon completion of the
microfilming the jacket is to be returned to the
reviewer by the contractor.
d. Insert the jacket in a brown, gummed envelope with the
words CONFIDENTIAL BUSINESS INFORMATION and TO BE
OPENED BY ADDRESSEE ONLY printed or stamped on the
outside, and seal. If more than one jacket is
involved, use a 12 x 10 x 8 shipping box ordered
through the GSA supply store with only the
contractor's full mailing address on it.
e. Place the envelope in a second brown, gummed envelope
with only the contractor's full mailing address on it
and put it at the contractor's pick-up station.
f. When the jacket(s) is (are) returned from the
contractor to the reviewer, the Product Manager Team
DCA will return it (them) directly to the RD File Room.
(7) When a reviewer requests coding of a change in labeling
and/or confidential formula, he/she will:
a. Obtain a CBI red cover sheet (or if unavailable, use
the alternate cover specified in Section VI, and the
receipt form entitled "Receipt of Confidential Data"
from the DCA. Place the red cover sheet on top of the
confidential data in the jacket and affix the receipt
form to the front of the jacket.
b. Take the material to the Product Manager Team DCA so
that the DCA can log the material out on the ICS Data
Request form.
RD-5
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c. Indicate clearly on the "Receipt of Confidential Data"
form that the material is to be coded, and that upon
completion of the coding the confidential material is
to be returned to the reviewer by the contractor.
d. Place the CBI red cover sheet on top of the
confidential material, insert the material in a brown,
gummed envlope with the words CONFIDENTIAL BUSINESS
INFORMATION and TO BE OPENED BY ADDRESSEE ONLY printed
or stamped on the outside, and seal. If the material
is too bulky for the envelope, use a 12 x 10 x 8
shipping box ordered through the GSA supply store with
just the contractor's full mailing address on it and
put it at the contractor's pick-up station.
e. Place the envelope in a second brown, gummed envelope
with only the recipient's full mailing address on it
and put it at the contractor's pick-up station.
f. When the jacket(s) is (are) returned from the
contractor, the Product Manager Team DCA will return
it (them) directly to the RD File Room.
B. Amended Registrations. The following procedures are to be
followed in handling CBI submitted in support of an amended
registration:
(1) Upon receiving an amendment containing confidential data in
the mail, the reviewer will obtain from the PM Team DCA a
CBI red cover sheet (or if unavailable will use the
alternate cover specified in Section VI, 1B(2)), affix the
cover sheet to the top of the material, and have the DCA
take it to PCB for an accession number; the PM Team DCA
will then return with the accessioned material to the team
for further processing as described in Ic or d.
(2) If the amendment is received through PCB, the reviewer will
follow the procedures for new registrations in 1.
(3) Where a reviewer from TSS or BED requests CBI, the PM
Team's reviewer will obtain the information from the
Company Data Library and transmit the material according to
the procedures in Ic or d.
(4) If the registration is approved, the procedures specified
in Id (6) of this Section will be followed. If the
registration is denied, the procedures specified in Id (7)
will be followed.
C. Tolerance Petitions. The following procedures are to be
followed in handling CBI submitted in support of a tolerance or
exemption from tolerance:
RD-6
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(1) A tolerance petition coming into the Product Manager Team
through PCS will have a CBI red cover sheet (or if
unavailable/ the alternative specified in Section VI,
1B(2)) on it identifying it as containing CBI. Upon
receiving the petition, the receiving cleric or otherwise
authorized person will immediately log the petition in as
usual (or see that it is logged in) and move it to the
appropriate reviewer for review. The reviewer will
transmit the necessary copies of CBI-containing data to HED
in accordance with the procedures specified in 1 d(l)-(5).
Duplicate numbered copies of the data will be given to the
DCA to take to the Company Data Library for storage or
disposal.
(2) If in the course of reviewing the submission, the reviewer
finds it necessary to photocopy CBI for transmittal outside
Registration Division, he/she will obtain from the DCA the
form entitled REQUEST TO COPY OPTS CONFIDENTIAL BUSINESS
INFORMATION. After filling out the request form, the
reviewer will obtain his/her Product Manager's concurrence
on the form approving the request. The form will then be
taken by the reviewer, DCA, or otherwise authorized person
on the team to the OPP Confidential Document Copy Center
where the requested number of copies will be made by the
DCA operator in charge. The copies will be numbered,
logged and entered into the tracking system. (A product
manager desiring to photocopy CBI may fill out the same
form at the OPP Confidential Document Copy Center without
getting his branch chief's approval.) When the reviewer is
no longer actively working on the submission, the
correspondence jacket will be stored in a secured cabinet
as specified in Section IV, 1, of this manual unless the
material in it is used as a reference source, in which case
it will be kept locked in the reviewer's desk.
(3) In those cases where a reviewer requests typing of material
containing CBI from a contractor, he/she will follow the
procedures specified in 1 e.
(4) In those cases where a reviewer or Product Manager sends a
Federal Register document accompanied by Chemistry and
Toxicology Branch reviews which contain CBI to the Federal
Register Section or hand carries a final document
accompanied by such reviews for concurrence, he/she will:
a. Obtain a CBI red cover sheet (or if unavailable, use
the alternative specified in Section VI, lb(2)) from
the DCA and place it on top of the CBI-containing
material.
b. Transmit the material in a brown, gummed envelope with
the words CONFIDENTIAL BUSINESS INFORMATION stamped or
printed on the outside.
RD-7
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D. Amended Tolerance Petitions. Ihe following procedures are to be
followed in handling CBI submitted in support of an amended
tolerance petition.
(1) Upon receiving an amendment containing confidential data in
the mail, the reviewer will obtain from the PM Team DCA a
CBI red cover sheet (or if unavailable, use the alternative
specified in Section VI, lb(2)), affix the cover sheet to
the top of the material, and take it to PCB for an
accession number, then return with the material to the team
for further processing as set forth in 3a and b.
(2) If the amendment containing confidential data is received
through PCB and the reviewer requests an BED review, he/she
will transmit the data in accordance with the procedures
specified in lD(l)-(5).
(3) When a reviewer from BED requests CBI in order to review
the amendment, the PM Team reviewer will obtain the
information from the Company Data Library and transmit the
material according to the procedures in lD(l)-(5).
(4) Upon completion of the amendment action (approval or
rejection), the correspondence jacket will either be kept
in a secured cabinet as specified in Section IV, 1, or
transferred to the Company Data Library by the DCA.
E. RPARs. In those cases where a reviewer from the Special
Pesticide Review Division (SPRD) requests CBI in connection with
a Rebuttable Presumption Against Registration action, the PM
Team reviewer or otherwise authorized person will obtain the
data from the DCA in the Company Data Library, return with the
CBI to the team where it will be transferred to SPRD in
accordance with the procedures set forth in ld(l)-(5). When the
material is returned to the PM Team reviewer from SPRD, he/she
will return it to the Company Data Library or give it to the DCA
or otherwise authorized person, who will return it to the
Company Data Library.
F. Congressional Material. In transmitting CBI to a Congressional
Committee, obtain the blue Privileged Information Control Record
from the DCO and affix it to the front of the envelope
containing the CBI. As in Section VI 4A of the manual, this
material is transmitted through the office of the Deputy
Assistant Administrator of OPP.
G. Miscellany. Problems arising in connection with infrequent
actions which are covered in other sections of this manual, such
as destruction of CBI, transmittal of CBI outside EPA, requests
from registrants to photocopy their own CBI, and requests from
divisions other than HED and SPRD for CBI, should be referred to
the DCO. Any CBI problems not covered by these procedures
should be referred to the DCO. In any unusual situation
involving CBI, do not act on your own; always call the DCO.
RD-8
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2. PROCESS COORDINATION BRANCH PROCEDURES
The following security procedures for the Process Coordination Branch
are listed by administrative or operational units:
A. Coordination Section.
(1) Nail Room. The mail clerks will separate out the
CBI-marked mail from the non-CBI mail by putting the CBI
mail in a locked box, which will be transported on the mail
cart along with the non-CBI mail as part of the regular
mail run. The CBI mail will be delivered along with the
non-CBI mail except that it will be kept in the locked box
until it is brought to its destination. The mail room will
never be left open unattended. No employees other than
mail room personnel will normally be permitted inside. If
for any reason, mail room personnel cannot be in
attendance, the door will be locked and a sign posted on it
saying when the personnel will return.
(2) Registration Support Team. The DCA in the Registration
Support Team will receive the submission (registration
application/amendment or tolerance petition/amendment) and
determine whether or not it contains CBI unless the
submitter has already claimed that it contains CBI. If it
does and it is a registration action, the DCA will hand
carry the submission to the clerk- typist, who assigns a
file symbol and registration number. If the submission is
a tolerance petition, the DCA will hand carry it to a team
member, who puts it in a jacket and assigns a petition
number. The clerk- typist will stamp on the jacket
CONFIDENTIAL BUSINESS INFORMATION - DOES NOT CONTAIN
NATIONAL SECURITY INFORMATION (E.O. 12065) and place a CBI
red cover sheet (or a substitute as specified in Section
VI, 1B(2) of this manual) on top of the material. The
submission will then be processed through the team as usual
in accordance with the regular work procedures as well as
the routine security procedures outlined in Section IV of
this manual.
(3) Liaison Team.
a. Upon receipt of the submission from the clerk-typist
in the Registration Support Team, the Liaison Team
clerk will hand carry the submission as usual to the
pesticide clerk on the Product Manager Team. If the
Liaison Team clerk is unable to complete delivery of
the submission by close of business, he/she will store
it in a secured cabinet as specified in Section IV, 1,
and make delivery the morning of the next work day.
(In the case of confidential data to be sent to HED,
'the originator will already have prepared the package
RD-9
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in accordance with security procedures; thus, the
Liaison Team Chemist in addition to performing the
usual operations of prioritization and assignment of a
projected completion date, need only fill out the Data
Review Record when the package goes out to HED and
when it comes back in.)
b. Upon receiving in the mail an inert ingredient
submission containing confidential data which must be
sent to HED for review, the Inert Ingredient Product
Manager will:
_1_. Obtain from the DC A in the Liaison Team the form
entitled REQUEST TO COPY OPTS CONFIDENTIAL
BUSINESS INFORMATION. After filling out the
request form, the Inerts Product Manager will
obtain the Coordination Section Chief's
concurrence on the form approving the request.
The form will then be taken by the Inerts PM or
otherwise authorized person on the team to the
OPP Confidential Document Copy Center where the
required number of copies will be made by the DCA
operator in charge.
2. Log the data out on the Data Review Record
(including assigning a control number and dating).
3» Obtain from the Liaison Team DCA a CBI red cover
sheet (or if unavailable, use the alternate cover
specified in Section VI, 1B(2)) and the "Receipt
of Confidential Data" form.
4^ Attach the cover sheet and the Data Review Record
on top of the data.
c. Give the package to the DCA of the Inert Ingredient
Product Manager Team to hand carry to the Liaison Team
Chemist (for prioritizing and completion date) from
where it will be transferred to HED.
d. When the CBI is returned to PCB, the Liaison Team
Leader, DCA, or otherwise authorized person on the
Inert Ingredient Product Manager Team will pick up the
material. The DCA will log the material back in on
the Data Review Record.
e. Where the Liaison Team Leader is to transmit to OGC a
final Federal Register document which includes HED
reviews containing CBI, the Team Leader will obtain
from the Liaison Team DCA a CBI red cover sheet (or a
substitute as specified in Section VI, 1B(2)> and the
"Receipt of Confidential Data" form and attach them to
the front of the document folder, place the folder in
RD-10
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a brown, gummed envelope, seal and address the
envelope, and then take the package to the DC A, who
will stamp on the outside CONFIDENTIAL BUSINESS
INFORMATION - DOES NOT CONTAIN NATIONAL SECURITY
INFORMATION (E.O. 12065). The Team Leader will then
give the package to the Coordination Section
Secretary, who will hand carry the package to OGC.
The Secretary will pick up the package from OGC when
it has been signed off (including the "Receipt of
Confidential Data") and return the package to the Team
Leader.
B. Emergency Response Section.
(1) Emergency Exemption Team.
The Emergency Exemption Team receives specific
exemption requests from states and Government agencies
through the mail room, the Process Coordination
Branch, the Communications Center, and Federal
Express. After processing the request in accordance
with established team procedures, the Secretary will
transmit the request to the front-end reviewer to
determine whether scientific reviews are needed. If
in connection with a specific exemption request, the
front-end reviewer receives CBI, he/she should obtain
from the Emergency Response Section DCA a CBI red
cover sheet (or a substitute as specified in Section
VI, paragraph 1B(2)) and attach it to the material if
this has not already been done. In the course of
reviewing such a CBI-containing request, all reviewers
will follow the routine security procedures outlined
in Section XV, (paragraph 3), of this manual. In
those cases where a review is requested from the
Hazard Evaluation Division (HED), the front-end
reviewer will:
JL. Obtain from his/her DCA the form entitled REQUEST
TO COPY OPTS CONFIDENTIAL BUSINESS INFORMATION.
After filling out the request form, the reviewer
will obtain his/her supervisor's concurrence on
the form approving the request. The form will
then be taken by the reviewer, DCA, or otherwise
authorized person on the team to the OPP
Confidential Document Copy Center where the
requested number of copies will be made by the
DCA operator in charge. The copies will be
numbered and entered into the tracking system.
(A supervisor desiring to photocopy CBI may fill
out the same form at the OPP Confidential
Document Copy Center without getting his/her
supervisor's approval.) While the reviewer is no
longer actively working on the request, the
RD-11
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jacket should be stored in a secured cabinet as
specified in Section IV of this manual.
2. Log out the data on the usual Data Review Record
(including assigning a control number and dating).
3^ Obtain from the Emergency Response Section DCA a
CBI red cover sheet (or if unavailable, use the
alternate cover specified in Section VI, 1B(2))
and the "Receipt of Confidential Data" form.
^. Attach the cover sheet and Data Review Record on
top of the data.
^. Rand carry the package to PCB (for prioritizing
and completion date) from where it will be sent
to HED.
£• When the CBI is returned to PCB, the front-end
reviewer or other authorized person in the
Emergency Response Team will pick up the material.
!_• After the reviews are completed, should a
reviewer find it necessary to destroy extra
copies of confidential data, he/she will:
a^ Obtain from the Emergency Response Section
~ DCA the form entitled REQUEST TO DESTROY
OPTS CONFIDENTIAL BUSINESS INFORMATION.
b. Fill out the form and have it approved by
~~ the DCO.
c. Hand carry the data in a brown, gummed
envelope or 12 x 10 x 8 shipping box to the
OPTS Paper Pulverizer in Waterside Mall,
where it will be destroyed by authorized
personnel.
b. Where a reviewer receives a tolerance petition/amendment
containing CBI, the reviewer will:
TL» Follow the routine security procedures outlined in
Section IV, 3, and transmit the necessary copies of
confidential data to HED in accordance with the
procedures specified in 2a(l)(a)-(e) in this section
of the security manual.
2. Where the reviewer is to transmit to OGC a final
Federal Register document which includes HED reviews
containing CBI, the reviewer will obtain from the
Emergency Response Section DCA a CBI red cover sheet
(or a substitute as specified in Section VI, 1B(2))
and the "Receipt of Confidential Data" form and attach
RD-12
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them to the front of the document folder, place the
folder in a brown, gummed envelope, seal and address
the envelope, and then take the package to the OCA,
who will stamp on the outside CONFIDENTIAL BUSINESS
INFORMATION - DOES NOT CONTAIN NATIONAL SECURITY
INFORMATION (E.O. 12065). The reviewer will then
either hand carry the package to OGC or give the
package to an otherwise authorized person who will
hand carry it to OGC. The reviewer or otherwise
authorized person will pick up the package from OGC
when it has been signed off (including the "Receipt of
Confidential Data" form).
3_. Where the reviewer is to transmit to RED or SPRD a
final Federal Register document which includes HED
reviews containing CBI, the reviewer will obtain from
the DCA a CBI red cover sheet (or a substitute as
specified in Section VI, 1B(2)) and the "Receipt of
Confidential Data" form and attach them to the front
of the document folder, place the folder in a brown,
gummed envelope, seal and address the envelope, and
then take the package to the DCA, who will stamp on
the outside CONFIDENTIAL BUSINESS INFORMATION - DOES
NOT CONTAIN NATIONAL SECURITY INFORMATION (E.O.
12065). After logging out the document on the Data
Review Record, the reviewer will then hand carry the
package with copies of the Submission Review Record
attached to the Liaison Team Chemist for
prioritization and completion date. When the signed
document comes back from HED or SPRD (including the
"Receipt of Confidential Data"), the reviewer or
otherwise authorized person will pick it up from PCB.
4^. Where the reviewer is to transmit to the Director of
the Registration Division a final Federal Register
document which includes HED reviews containing CBI,
the reviewer will place the document with the CBI red
cover sheet (or its substitute) in the out box of the
Emergency Response Section from where it will be
delivered by the Section Secretary or otherwise
authorized person to the office of the PCB Chief for
concurrence and transmittal to the Registration
Division Director's office for sign-off. (After
sign-off by the Director, the document will be
forwarded to the Federal Register Section by the
Director's office using its own delivery procedures.)
5. After the reviews are completed/ should the reviewer
find it necessary to destroy extra copies of
confidential data, he/she will:
a. Obtain from the Emergency Response Section DCA
the form entitled REQUEST TO DESTROY OPTS
CONFIDENTIAL BUSINESS INFORMATION.
RD-13
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Jb. Fill out the form and have it approved by the DCO.
£. Hand carry the data in a brown, (jammed envelope
or 12 x 10 x 8 shipping box to the OPTS Paper
Pulverizer in Waterside Mall, where it will be
destroyed by authorized personnel.
(2) I. D. Team. When in the course of reviewing an enforcement
action, the reviewer requires a registration jacket
containing CB1, he/she will have the I. D. Team clerk get
it from the Product Manager Team and process it in
accordance with the usual work procedures. In the course
of reviewing the material, the reviewer should follow the
routine security procedures outlined in Section IV, 3, of
this manual. In those cases where a reviewer requests a
review from a Technical Support Section (TSS), the
Emergency Response Section's DCA will log out the data on
the Data Review Record (including assigning a control
number and dating). After obtaining a CBI red cover sheet
(or a substitute as specified in Section VI, 1B(2)) from
the Response Section DCA and affixing it on top of the
CBI-containing material, the reviewer will give the jacket
to the I. D. Team clerk, who will then hand carry the
material to the receiving clerk or DCA in a TSS for logging
in. (The Herbicide-Fungicide TSS requires that all CBI
material be received by the DCA only.) When the TSS clerk
delivers the material with the completed TSS review back to
the I. D. Team, the I. D. clerk will immediately log the
jacket back in and hand the package to the reviewer. Every
effort should be made to minimize the time that the jacket
lies around in the in-box. When the reviewer no longer
needs the registration jacket, he/she will give it to the
I. D. clerk, who will log it out and hand carry it back to
the original Product Manager Team.
3. TECHNICAL SUPPORT SECTION SECURITY PROCEDURES
A. Upon receipt of a registration jacket and/or a submission to be
reviewed, the TSS clerk or DCA will log in the material in the
Section's log book and then store the package in a secured
cabinet as specified in Section IV, 1, of this manual until a
reviewer is ready to work on the submission. The jacket or
submission should already be stamped CONFIDENTIAL BUSINESS
INFORMATION - DOES NOT CONTAIN NATIONAL SECURITY INFORMATION
(E.O. 12065) and contain a red CBI, cover sheet over the
confidential data. If this has not been done, the clerk or
secretary should give the package to the section's DCA, who will
correct the deficiencies.
B. In the course of reviewing the submission, the reviewer will
follow the routine security procedures outlined in Section IV,
3, of this manual.
RD-14
-------
(1) In those cases where a reviewer requests typing of a review
containing CBI from a contractor, he/she will:
a. Obtain a CBI red cover sheet (or a substitute as
specified in Section VI, 1B(2)) from the DCA and place
it on top of the draft.
b. Place the material in a brown, gummed envelope (or a
12 x 10 x 8 shipping box ordered through the GSA
supply store if a large number of reviews are
involved) addressed to the contractor with the words
CONFIDENTIAL BUSINESS INFORMATION and TO BE OPENED BY
ADDRESSEE ONLY printed or stamped on the outside.
c. Place the envelope inside a second brown, gummed
envelope with only the recipient's full mailing
address on it if the 12 x 10 x 8 shipping box is not
used.
d. Obtain from the DCA, EPA Form 7710-9 "Request for
Typing/Editing," and after filling out the form
completely, including inserting the words CONFIDENTIAL
BUSINESS INFORMATION in block 20, attach the form to
the outside of the envelope or 12 x 10 x 8 shipping
box.
e. Give the package to the DCA, who will retain the
yellow control copy from EPA Form 7710-9.
(2) The DCA will then hand carry the package to the branch
office, where he/she will put it in the contractor's
pick-up box.
(3) When the typed final is returned from the contractor, the
DCA will pick it up from the return box in the branch
office, log it in on the yellow control copy of the EPA
Form 7710-9, and hand it to the reviewer or hold it in a
secured cabinet as specified in Section IV, 1, until such
time as he/she can hand it to the reviewer.
(4) When the typed final has been signed off and is ready to go
back to the originator, the reviewer will link it up with
the rest of the original jacket and/or submission and hand
the package to the clerk or DCA, who will log it out in the
Section Log Book and return it to the originator.
RD-15
-------
REGISTRATION DIVISION DATA REVIEW RECORD
Confidential Business Information - Does Hot Contain National Security Information (1.0. 12065)
Chemical lame
I To Be Completed By PM
Identifying "umber 3. Action Code 4. Accession Bumber
5. Record Mumber
6. lUterence Number
7. Data Received (SPA)_
8. Statutory Due
9. Product Manager
10. PN Team Number
I To Be Completed By PCB
I
111. Data Sent to HRD/TSS
I
|12. Priority Humber
I
(13. Projected Return Date
14. CHECK TUX FOLLOWING IF APPLICABLE:
MPublic Health/Quarantine MHinor Use
QSubstitute Chemical l_|Part of IPM
j~!Seasonal Concern |_|Review Requires
~ Less Than 4 Hrs.
15. INSTRUCTIONS TO REVIEWER
A. HBD IJTotal Assessment - 3(c)(5) C. IJ BFSD D. Q TSS/RD I. Q Other
|_|Incremental Risk Assessment -
~" 3{c)(7) and/or B.L. Johnson F. Instructions
memo of May 12, 1977.
B. SPRD (Send Copy of Form to SPRD PM)
| (Chemical Undergoing Active
~ RPAR Review
|_|Chemical Undergoing Active
Registration Standards Review
16. Related Actions:
17. 3(c)(l)(D)
I | Use Any or All Available Information |_| Use Only Attached Data
I I Use Only the Attached Data'for Formulation and Any or All Available
Information. On the Technical or Manufacturing Chemical.
18. Reviews Sent To: |~|TB M RGB |~|EEB |~|EFB |~|EF |~|CH |~|PL
19
TO
TYPE OF REVIEW
TOXICOLOGY
ECOLOGICAL EFFECTS
RESIDUE CHEMISTRY
ENVIRONMENTAL FATE
CHEMISTRY
EFFICACY
PRECAUT. LABELING
ECONOMIC ANALYSIS
REGIS.
PETIT.
EUP
SLN
SEC. 18
INERT
US
OTHER |
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
20. |_l Label Submitted With Application Attached.
21. |_| Confidential Statement
of Formula Attached
22.
23.
24.
|_| Representative Labels Showing Accepted Uses Attached.
Data Returned to RD (to be completed by BED)
Include an Original and 4 (four) Copies of This Completed Form for Bach Branch
Checked for Review.
RD-16
-------
SPECIAL PESTICIDE REVIEW DIVISION
SECURITY PROCEDURES
1. Procedures for Receiving CBI into SPRP Document Control Officer
Responsibilities
As soon as documents containing CBI are received in SPRD, they will
be hand carried to the DCO/DOA located in Room 724B. The DCO/DCA
will maintain a control log and using the FIFRA procedures will
transmit the information to the appropriate branch, assuring that the
project manager signs for the information. The DCO will assure that
this data is kept in an approved CBI file cabinet.
In the event that the chemical has not been assigned to a branch, the
DCO/DCA will log in the CBI information and retain it in her/his
locked file until it is assigned.
The DCO also maintains a separate log transmitting to and receiving
data from the typing contractor and ensures that the log is
initialled when data is picked up and delivered by the contractor and
the branch involved. See Attachment 3.
2. Section Chief and Project Manager Responsibilities
The section chief is responsible for overseeing the security of the
CBI information within his/her section.
The project manager is responsible for maintaining security of the
data he/she is currently working on. He/she is also responsible for
obtaining any information not previously assigned from the DCO and
signing for it. The project manager will be responsible for logging
CBI information through the DCO/DCA when sending the information to
another division for review.
3- Procedure for Safeguarding Proprietary Information from Unauthorized
Release
Project managers must prepare and attach a bibliographic reference
sheet to all packages submitted by the Special Pesticide Review
Division (SPRD) to other groups for validation or assessment.
References must be identified as to their status if they are
confidential from a company source. Data referenced may have
originally been submitted to EPA by registrants of pesticide products
and/or petitioners for a tolerance. The company has certain rights
to confidentiality of such data under appropriate statutes.
It is the responsibility of each Project Manager to assure the status
of all references before they are released to any other group, either
inside or outside the Agency. Project Managers can refer to agency
regulations for safeguarding proprietary data for definitions and
examples of confidential data. These regulations were published
SPRD-1
-------
in the Federal Register and SPRO's Administrative Officer has a copy
on file. The PM's can also consult the Office of Pesticide Programs
Freedom of Information (FOI) Officer or staff in the Information
Services Branch, Program Support Division for clarification of the
status of a document or assistance in obtaining clearance. The FOI
Officer maintains a listing of data and companies to which the data
belong. The status of data submitted to the Agency for registration
of pesticide products is considered confidential unless otherwise
identified under the FOI. If all or part of such data has been
officially cleared through the FOI system, then an official letter
written by the FOI office will be included in the file indicating
such. The Project Manager must place a copy of this release letter
in the RPAR files and indicate the status in bibliographic citations.
Data found in the open literature through either computer based
searches or manual searches are totally releaseable without going
through the FOI officer. If a reference found in the open literature
is also cited in a company file, then the reference would not be
considered confidential or trade secret if it is identical in all
respects.
An example of how references should be marked follows. All citations
are non-confidential unless marked with the C. C indicates
confidential data which should not be released.
BIBLIOGRAPHY*
1. Amer, S.M. And E.M. Ali
Cytological Effects of Pesticides
Cytologia, 39:633-643. 1974
2. Buu-Hoi, N.P. et al.
Biochemistry: Carcinominmetic Properties of
Tetrachloro-2,3,7,8 Debenz o-p-dioxin.
C.R. Acad. Sc. Paris,x272:1447-1450. 1971
3. Goto, M. Et al.
Contributions to the Ecological Chemistry. II.
Hepatoma Formation in Mice after Administration
of high Doses of BHC isomers.
Ehcmosphere. 1 (6):279-282. 1972
4. Green, Sidney
Cytogenetic Evaluation of Several Dioxins in the
rat. Draft Documents (Confidential).
*A11 requests for copies of the referenced material must be submitted to the
Freedom of Information Officer, Office of Pesticide Programs. A cost of $0.20
per page is charged for reproduction.
SPRD-2
-------
Confidential/proprietary information used during the RPAR process and
ultimately retained as part of the administrative record must be
identified with a confidential red cover sheet (Appendix C2 in
manual). The precautionary statements on the red cover sheet are to
be followed without exception.
SPRD's DCO maintains a supply of confidential red border cover
sheets. Work papers and working drafts must be stamped with "FOR
OFFICIAL USE ONLY ~ Public availability to be determined unde 5
U.S.C. 522." All branches have been given a supply of these stamps
and others can be purchased at the GSA Self-Service Store.
4. COMPUTER SECURITY
The Special Pesticide Review Division has a secure,
password-protected computer system which is limited to authorized
users only. Ihe system also has the capability to keep records on
system use by each operator.
The system has both a back up disk and tape which enable the Division
to recover accidently lost information if the disk or tape systems
fail. These disks and tapes are stored in a locked cabinet at the
end of each working day.
SPRD-3
-------
SPRD Attachment 1
ENVIRONMENTAL PROTECTION AGENCY
SPRD CONFIDENTIAL BUSINESS INFORMATION
INVENTORY LOG AND USER
COPY SIGN OUT LOG
a
SPRD
Doc.
No.
No.
of
Pages
Rec.
From
Description
Cover
sheet
Attached
Date/Time
Checked
Out
Last
Name
.
Signature
Date
Returned
Destroyed
Date
Name
ID
Recp.
Rec.
Returned
to
Sender
Date
Name
ID
DCO
Initials
«•
*
CO
1
1
-------
SPRD Attachment 2
CONFIDENTIAL BUSINESS INFORMATION RECEIPT
Control No.
Raven Request No.
Branch
Preparer's Name & Phone Number:
Received by
Contractor's Signature
Date
RETURN THIS FORM TO TS-791,
Special Pesticide Review Division
Room 724B, Crystal Mall Bldg. 2
SPRD-5
-------
SPRD Attachment 3
CONFIDENTIAL BUSINESS INFORMATION TRANSMITTING LOG:
Brancii (Contractor (C.B.T.
Request No. (Control No.
Signature, Date & Time of Persons Transmitting/Receiving Document
In to Dir Off Out to Contractor
In from Contractor
In to Branch
VO
§
0.
w
-------
APPENDIX A-1
I. ACCESS AUTHORIZATION FOR FIFRA CONFIDENTIAL BUSINESS INFORMATION (CBI)
Full Name EPA ID ' Position Office (include Division
IT IS THE RESPONSIBILITY OF EACH AUTHORIZING OFFICIAL**TO ENSURE THAT EMPLOYEES
UNDER HIS/HER SUPERVISION OBTAIN ACCESS ONLY TO THAT INFORMATION REQUIRED TO
PERFORM OFFICIAL DUTIES UNDER FIFRA.
Signature of Authorizing Official Date
Title Location
Local Document Control Officer (DCO) Phone
Designating Officials Must be Division Directors (or Equivalent) or Above
II.
CONFIDENTIALITY AGREEMENT FOR EPA EMPLOYEES
I understand that I will have access to certain Confidential Business
information submitted under the Federal Insecticide, Fungicide and Rodenticide
Act as amended by PL 92-396. This access has been granted in accordance with
my official duties as an employee of the Environmental Protection Agency.
I understand that the FIFRA Confidential Business Information may not be
disclosed except as authorized by FIFRA and Agency regulations. I understand
that undersection 10f of FIFRA, I am liable to a possible fine of up to $10,000
and/or imprisonment for up to one year if I will fully disclose FIFRA Confiden-
tial Business Information to any person not authorized to receive it. Addi-
tionally, I understand that according to section 114(b)(3), FIFRA provides for
a penalty of up to $10,000 and up to three (3) years imprisonment for
disclosure of formula information (manufacturing process, quality control
processess, and production data) with intent to defraud.
I agree that I will treat FIFRA Confidential Business Information furnished to
me as confidential and that I will follow the procedures set forth in the
Office of Pesticide Programs Security Manual.
I have read and understand the procedures.
I am aware that I may be subject to criminal penalties under 18 U.S.C. 1001 if
I have made any statement of material facts knowing that such statement is
false or if I willfully conceal any material fact.
Signature Date
Name (Print) EPA I.D. Number
-------
APPENDIX A-2
CONFIDENTIALITY AGREEMENT FOR
UNITED STATES EMPLOYEES UPON TERMINATION OR TRANSFER
In accordance with my official duties as an employee of the United States, I
have had access to Confidential Business Information under the Federal
Insecticide, Fungicide, and Rodenticide Act as amended (FIFRA, 7 U.S.C. 136 et
seq.). I understand that FIFRA Confidential Business information may not be
disclosed except as authorized by FIFRA or Agency regulations.
I certify that I have returned all copies of any FIFRA Confidential Business
information in my possession to the appropriate document control officer
specified in the procedures set forth in FIFRA Confidential Business
Information Security Manual.
I agree that I will not remove any copies of FIFRA Confidential Business
Information from the premises of the Agency upon my termination or transfer.
I further agree that I will not disclose any FIFRA Confidential Business
Informtion to any person after my termination or transfer.
I understand that as an employee of the United States who has had access to
FIFRA Confidential Business Information, under section 10(f) of FIFRA I am
liable for a possible fine of up to $10,000 and/or imprisonment for up to one
year if I willfully disclose FIFRA Confidential Business Information to any
person. Additionally, I understand that according to section 14(b)(3), FIFRA
provides for a penalty of up to $10,000 and up to three (3) years imprisonment
for disclosure of formula information (manufacturing process, quality control
processes, and production data) with intent to defraud.
If I am still employed by the United States, I also understand that I may be
subject to disciplinary action for violation of this agreement.
I am aware that I may be subject to criminal penalties under 18 U.S.C. 1001 if
I have made any statement of material facts knowing that such statement is
false or if I willfully conceal any material fact.
SIGNATURE DATE
NAME ID NUMBER
-------
APPENDIX B-1
FIFRA CONFIDENTIAL BUSINESS INFORMATION
MEETING SIGN-IN SHEET (EPA ONLY)
DATE: TIME:
PLACE: (Room) (Building) (City)_
CHAIRPERSON:
SUBJECT OF MEETING:
NAME (PRINT) SIGNATURE OFFICE/DIVISION/BRANCH EPA ID
THIS SIGN-UP SHEET MUST BE GIVEN TO THE APPROPRIATE DCO/DC;.
-------
APPENDIX B-2
CBI MEETING REPORT
Date Time Location
Subject
{and/or)
EPA Reg. No. Pesticide Petition No.
Company(s) Involved
Pesticide Company Representatives
Printed Signed
Printed Signed
Printed Signed
Brief Summary of Discussion (For additional space see addendum)
Action Taken or Recommendation
EPA Representatives Office
Recorder
-------
APPENDIX C-l
CONFIDENTIAL BUSINESS INFORMATION
DOES NOT CONTAIN
NATIONAL SECURITY INFORMATION (EO 12065)
CONFIDENTIAL BUSINESS INFORMATION
DOES NOT CONTAIN
NATIONAL SECURITY INFORMATION (EO 12065)
SOME INFORMATION IN THE ATTACHED MATERIAL MAY BE ENTITLED
TO TREATMENT AS TRADE SECRET OR PROPRIETARY DATA UNDER
SECTION 7(d) AND SECTION 10 THE FEDERAL INSECTICIDE, FUNGICIDE
AND RODENT1CIDE ACT (FIFRA) AS AMENDED,
SOME INFORMATION IN THE ATTACHED MATERIAL MAY BE ENTITLED
TO TREATMENT AS TRADE SECRET OR PROPRIETARY DATA UNDER
SECTION 7(d) AND SECTION 10 THE FEDERAL INSECTICIDE, FUNGICIDE
ANDRODENTICIDE ACT (FIFRA) AS AMENDED.
ANY PERSON HANDLING OR USING THE ATTACHED DATA IN ANY WAY
IS RESPONSIBLE FOR PREVENTING UNAUTHORIZED DISCLOSURE WHILE
IN HIS POSSESSION. SECTION 12(a)(2)(D) MAKES IT UNLAWFUL FOR ANY
EMPLOYEE TO USE TO HIS OWN ADVANTAGE OR TO REVEAL ANY CON-
FIDENTIAL INFORMATION (EXCEPT TO PERSONS NEEDING THE INFOR-
MATION FOR THE PERFORMANCE OF OFFICIAL DUTIES). A PENALTY OF
UP TO $10,000 FINE AND UP TO 3 YEARS IMPRISONMENT MAY RESULT
FROM CONVICTION OF A VIOLATION ON SECTION 12(a)(2)(D).
SECTION 10(f) MAKES IT A CRIME FOR ANY EMPLOYEE TO DISCLOSE
CONFIDENTIAL INFORMATION EXCEPT AS AUTHORIZED BY SECTION 7
AND 10 OF FIFRA. A PENALTY OF UP TO $10,000 FINE AND UP TO ONE
YEAR IN JAIL MAY RESULT FROM CONVICTION OF A VIOLATION OF
SECTION 10(f).
THE ATTACHED INFORMATION IS NOT TO BE PUBLISHED, REPRODUCED,
PUBLICLY DISCUSSED, INCLUDED IN RESPONSE TO AN FOI REQUEST
OR OTHERWISE RELEASED WITHOUT THE EXPLICIT WRITTEN AUTHORI-
ZATION OF THE APPROPRIATE DIVISION DIRECTOR OR HIS DESIGNEE.
-------
APPENDIX C-2
CONFIDENTIAL BUSINESS INFORMATION
DOES NOT CONTAIN
NATIONAL SECURITY INFORMATION (EO 12065)
SOME INFORMATION IN THE ATTACHED MATERIAL MAY BE ENTITLED
TO TREATMENT AS TRADE SECRET OR PROPRIETARY DATA UNDER
SECTION 7(d) AND SECTION 10 THE FEDERAL INSECTICIDE, FUNGICIDE
AND RODENTICIDE ACT (FIFRA) AS AMENDED.
ANY PERSON HANDLING OR USING THE ATTACHED DATA IN ANY WAY
IS RESPONSIBLE FOR PREVENTING UNAUTHORIZED DISCLOSURE WHILE
IN HIS POSSESSION. SECTION 12(a)(2)(D) MAKES IT UNLAWFUL FOR ANY
EMPLOYEE TO USE TO HIS OWN ADVANTAGE OR TO REVEAL ANY CON-
FIDENTIAL INFORMATION (EXCEPT TO PERSONS NEEDING THE INFOR-
MATION FOR THE PERFORMANCE OF OFFICIAL DUTIES). A PENALTY OF
UP TO $10,000 FINE AND UP TO 3 YEARS IMPRISONMENT MAY RESULT
FROM CONVICTION OF A VIOLATION ON SECTION 12(a){2)(D).
SECTION 10(f) MAKES IT A CRIME FOR ANY EMPLOYEE TO DISCLOSE
CONFIDENTIAL INFORMATION EXCEPT AS AUTHORIZED BY SECTION 7
AND 10 OF FIFRA. A PENALTY OF UP TO $10,000 FINE AND UP TO ONE
YEAR IN JAIL MAY RESULT FROM CONVICTION OF A VIOLATION OF
SECTION 10(f).
THE ATTACHED INFORMATION IS NOT TO BE PUBLISHED, REPRODUCED,
PUBLICLY DISCUSSED, INCLUDED IN RESPONSE TO AN FOI REQUEST
OR OTHERWISE RELEASED WITHOUT THE EXPLICIT WRITTEN AUTHORI-
ZATION OF THE APPROPRIATE DIVISION DIRECTOR OR HIS DESIGNEE.
-------
V-
APPENDIX O3
mloam Biuitss mmxim - DOES
NOT CONTAIN NATKOL SECORiTY INFORMATION
(E.0.12065)
-------
tttVIRGNHKNTAL PROTECTION AGENCY
PIFRA CONFIDENTIAL BUSINESS INFORMATION
USER SIGN otrr we
bate/Tine
I awoked
! Out
ItBte
riM
Date
MM
Mt«
riM
tat*
MM
tat*
riM
tat*
riM
tat*
MM
IMt«
TlM
teta
TlM
Data
TlM
OPP Docment
Control NiMbar/
Copy NiMlMr
EPA ID
Nuaber
USER INFORMATION
Last NAM
Signature
DOO
Initial
Date
Returned
DCO
Initial
Date
Destroyed
DCO
Initial
Contents
-------
APPENDIX E-l
DATE OF REQUEST
REQUEST FOR TYPING/EDITINC
REQUEST NUMBER
2N9 35557
REQUESTOR
NAME
OFFICE
LOCATION
PHONE NO.
TYPE OF ORIGINAL
'• | MEMO
i I FORM LETTER
!|REPORT
TYPING REQUIRED
DOUBLE-SPACED DRAFT
TYPED FINAL
^DOUBLE-SPACED DRAFT, SPECIAL FORMAT
~3CLEAN TYPED FINAL. SPECIAL FORMAT
EDITING REQUIRED
MAGNETIC CARD REQUIRED
9 ~1 LIGHT EDITING
SUBSTANTIVE EDITING
10
REQUESTED TURNAROUND TIME
11 j | OVERNIGHT
1 I 24 HOUR
CD 2 DAY
DAY
ACTION DATES
.BATE?
RECEIVED BY PROJECT OFFICER
12
RECEIVED FROM CONTRACTOR
15
REJECTED BY PROJECT OFFICER
13
RETURNED TO ORIGINATOR
16
SENT TO CONTRACTOR
14
COMMENTS
17
18
19
20 CONFIDENTIAL BUSINESS DtfORMATION
21 Enter log number
EPA HQ Foim 7710-9(7-71)
COPY 1-To b* retained by ORIGINATOR
-------
APPENDIX E-2
RECEIPT OF CONFIDENTIAL DATA
I have received the Confidential Material submitted by
(Name) (Branch) (Room)
(Date) Document Control Assistant
please acknowledge
I have received the Confidential Material submitted to
me from .
(Date)(Name)
-------
APPENDIX E-3
FIFRA Federal Non-OPTS Employee
Confidentiality Agreement
I understand that as an employee of a Federal agency that has
obtained certain Confidential Business Information submitted to the
Environmental Protection Agency under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) (7 U.S.C. 136 et seg..), I will have accesss
to such information. This access has been granted in accordance with my
official duties under a law to protect health or the environment or for
specific law enforcement purposes.
I understand that FIFRA Confidential Business Information may not be
disclosed by me except as authorized by FIFRA, the agreement between my
agency and the Environmental Protection Agency, and the security procedures
in effect at my agency. I understand that under section 10(f)(3) of FIFRA,
I am liable for a possible fine of up to $10,000 and/or imprisonment for up
to three years if I willfully disclose FIFRA Confidential Business
Information to any person not authorized to receive it. In addition, I
understand that I may be subject to disciplinary action for violation of
this agreement up to and including dismissal.
I agree that I will treat any FIFRA Confidential Business Information
furnished to me as confidential and that I will follow the security
procedures in effect at my agency for the handling of this type of
information. I have been informed of and understand the procedures.
Signature Date
Typed Name
Title Telephone No.
-------
APPENDIX E-4
FIFRA Contractor Employee Confidentiality Agreement
I understand that as an employee of a contractor performing work for
the United States Environmental Protection Agency, I will have access to
certain Confidential Business Information submitted under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C.
136 et seq.). This access has been granted to me in order to perform my
work under the contract.
I understand that FIFRA Confidential Business Information may not be
disclosed by me except as authorized by FIFRA, the contract, and the
security procedures used by my employer under the contract. I understand
that under section 14(b)(3) of FIFRA, I am liable for a possible fine of up
to $10,000 and/or imprisonment for up to three years if I willfully
disclose FIFRA Confidential Business Information to any person not
authorized to receive it. In addition, I understand that I may be subject
to disciplinary action for violation of this agreement up to and including
dismissal.
I agree that I will treat any FIFRA Confidental Business Information
furnished to me as confidential and that I will follow the security
procedures used by my employer under the contract. I have been informed of
and understand the procedures.
Signature Date
Name
-------
APPENDIX F
REQUEST TO COPY OPTS CONFIDENTIAL BUSINESS INFORMATION
Requestor's Name
Organization
Date
(Please Print)
Mail Code
Phone No.
I request that the following documents which may contain OPTS Confidential
Business Information be copied. I understand that I am responsible and
accountable for all copies until I transfer custody.
No.
1
Description (Ace. #, Reg #, etc)
~
Number of
Original Pages
Number of |
Copies 1
Document
Control No.
Requestor's Signature
Approval
(Please Print)
(Signature)
Title
Organization
Copies Produced
Mail Code
By
Phone No.
(date)
(DCO/DCA)
-------
APPENDIX G
REQUEST TO DESTROY OPTS CONFIDENTIAL BUSINESS INFORMATION
Requestor's Name
Organization
Date
(Please Print)
Mail Code
Phone No.
I request that the following documents which may contain OPTS Confidential
Business Information be destroyed.
Room No.
1
2
3
4
5
6
7
8
9
10
Description (Ace. #, Reg #, etc)
Document Controlled
(Yes or No)
.
Document Control
Number
.
Requestor's Signature
Approval
(DCO Only)
(Please Print)
(Signature)
Title
Organization
Copies Produced
Mail Code
By
Phone No.
(date)
(DCO/DCA)
-------
Appendix H
Document Control Officers (DCOs)
and
Document Control Assistants (DCAs)
Benefits and Field Studies Division
DCO
DCA
DCA
(Name)
(Name)
(Name)
Hazard Evaluation Division
DCO
DCA
DCA '
(Name)
(Name)
(Name)
Program Support Divison
DCO
DCA
DCA
(Name)
(Name)
(Name)
Registration Division
DCO
DCA
DCA
(Name)
(Name)
(Name)
Special Pesticides Review Division
DCO
DCA
DCA
(Name)
(Name)
(Name)
(Room)
(Room)
(Room)
(Room)
(Room)
(Room)
(Room)
(Room)
(Room)
vRoom)
(Room)
(Room)
(Room)
(Room)
(Room)
(Phone)
(Phone)
(Phone)
(Phone)
(Phone)
(Phone)
(Phone)
(Phone)
(Phone)
(Phone)
(Phone)
(Phone)
(Phone)
(Phone)
(Phone)
-------
Appendix I
Procedures for Obtaining Interagency Agreements for
Furnishing FIFRA Confidential Business Information.
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a. If a particular Federal agency will have a continuing need for FIFRA Confidential
Business Information, the agency may obtain an interagency memorandum of agree-
ment for access to FIFRA Confidential Business Information.
b. The Deputy Assistant Administrator for Pesticide Programs may negotiate an inter-
agency agreement, in accordance with EPA Order 1610, with another Federal agency
for access to FIFRA Confidential Business Information if:
(1) The agreement meets the requirements of 40 CFR Part 2.
(2) The other agency agrees to treat all FIFRA Confidential Business Information
obtained from EPA in accordance with the agreement,
(3) The agreement sets forth the purposes for which the information is needed
and those purposes are in connection with the agency's duties under any laws
to protect health or the environment or for specific law enforcement purposes,
(4) The agreement specifies the security procedures that will be used for pro-
tecting the information, and the Deputy Assistant Administrator for Pesti-
cide Programs determines that the procedures will provide at least the same
degree of protection as these procedures (or the other agency has adopted
these procedures for purposes of the agreement), and
(5) The agreement specifies the procedures that will be followed by the other
agency in making specific requests for information under the agreement and to
whom the requests will be addressed.
c. The Deputy Assistant Administrator for Pesticide Programs or his/her designee,
shall notify the appropriate DCO's of the agreement and the procedures to be fol-
lowed in responding to specific requests.
d. Under such an agreement, if the applicable procedures in 40 CFR Part 2 have been
followed, a DCO may furnish Confidential Business Information to another Federal
agency, in accordance with Chapter III of these Procedures, without receiving
specific authorization from the Deputy Assistant Administrator for Pesticide Pro-
grams for each request.
5. Violations.
a. Any violation of another Federal agency's security procedures, when there is
no evidence of unauthorized disclosure, shall be investigated by that agency
and appropriate remedial action taken to correct the procedural deficiencies.
b. Any alleged or actual unauthorized disclosure of FIFRA Confidential Business
Information by another Federal agency shall be reported immediately by that
agency to the EPA Inspector General's office and the Deputy Assistant
Administrator for Pesticide Programs.
c. Any violations of the security provisions of an interagency agreement under
this chapter shall be investigated by the EPA Inspector General's office which
shall report to the Deputy Assistant Administrator for Pesticide Programs. If
the Deputy Assistant Administrator for Pesticide Programs finds that the other
agency has violated the terms of the interagency agreement, he or she may
terminate that agency's right of access pending resolution of the matter.
d. If the investigation by OIG develops information reflecting a possible crim-
inal violation, the case shall be referred to the Department of Justice.
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APPENDIX J
PERSONS AUTHORIZED TO REQUEST
CBI MATERIALS FROM OPP DOCUMENT CENTER
Division: Office Symbol:
1. The following named personnel assigned to this Division are authorized
to withdraw CBI material from the OPP Document Center in accordance with
Section V of the FIFRA CBI Security Manual.
a. Branch:
Names of Individuals Badge Number Room Telephone
b. Branch:
Names of Individual Badge Number Room Telephone
Certificate of CBI Clearance
All persons named above are cleared by this Division for access to CBI.
The access authorization forms and agreements specified in the FIFRA CBI
Manual are on file with the Division Document Control Officer.
Signature: Date
Division Document Control Officer
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