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US Environmental Protection Agency
Office of Pesticide Programs
Specifications for Creating PDF
Version of Study Reports
June 25, 2008
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US EPA, Office of Pesticide Programs - Electronic Submission and Review
June 25, 2008
Specifications for Creating PDF Version of Study Reports
revision 2
Format of Original Source Document
Feature
Software
Page size
Margins
Font Size/Style
- Text of study
report.
Font Size/Style
B Tabular
information
Specification
Any word processing or desktop publishing
software.
8.5"x 11".
At least 1 " on all sides.
12 point Times New Roman
12 point Courier.
Comments
Use any software that can print output to a postscript printer
format file (.ps) and subsequently converted to PDF format
(.pdf). One purpose of using Adobe® Acrobat® is to not
restrict original study creation to specific software.
An A-4 source document is allowable provided the resulting
PDF page size is set for 8.5" x 11".
12 point is desired, but if the PDF is created from an A-4 size
source, make it fit 8.5 111 format. It's OK if resulting font
size is not 12 point.
Use of specialty fonts for math or scientific purposes is
allowable provided these fonts are embedded in the resulting
pdf file.
Courier is preferred for tabular data since it is a fixed width
font. Other fixed width fonts may be suitable provided they
are embedded in the resulting pdf file.
Specifications for Creating PDF Version of Study Reports
Revision 2
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US EPA, Office of Pesticide Programs - Electronic Submission and Review
June 25, 2008
Format of Original Source Document
Font Type
Microsoft® True Type® or Adobe® Type 1.
Do NOT use proprietary fonts. These can not be embedded
in PDFs. Acrobat will try to use a substitute font but this may
alter document format, appearance, and print.
Tables
Use software "table" function rather than tabs or
blank spaces to create tabular layout.
Tabular text initially created in true tables and then converted
to PDF readily exports to other software. Use of tabs to
create the look of a table does not result in readily exportable
data.
Subscripts &
Superscripts
In tables, use letters; not numerals.
Tables may be converted to other software during review
process. Numerals may be converted to full size which may
result in mis-leading numbers in tables. Therefore, use
letters.
Text Color
Black.
» Indicates that there has been some change in the guidance from the previously posted version.
Specifications for Creating PDF Version of Study Reports
Revision 2
-------
US EPA, Office of Pesticide Programs - Electronic Submission and Review
June 25, 2008
Format and Creation of PDF File
Feature
Printing
File Format
PDF File
Compatibility
Software
Conversion to PDF
Options.
• First choice
Specification
Create PDF document after paper version
passes 86-5.
Adobe® Portable Document Format (PDF) -
Version 1.4 or higher.
Adobe® Acrobat® 5.0 or higher.
Use any software that can create a PDF version
1 .4 or higher and which can control the required
settings specified in this and other guidance
documents.
Comments
See guidance re Preparation and In-Processing of Studies
Submitted in PDF. Production sequence - paper, then PDF -
may change depending on registrant experience assembling
full submissions.
EPA staff will use Adobe® Acrobat® 5 (full program) to
perform reviews.
Goal is to create a text PDF rather than an image PDF. This allows text to be interpreted as words rather
than images thus allowing indexing, searching, text comparison, etc.
Convert directly from electronic source
document.
This provides full indexing for text and tables.
Specifications for Creating PDF Version of Study Reports
Revision 2
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US EPA, Office of Pesticide Programs - Electronic Submission and Review
June 25, 2008
Format and Creation of PDF File
• Second choice
Scan paper copy of study report. Process
through optical character recognition (OCR)
software such as Adobe Acrobat Capture,
ABBYY® Fine Reader®, or ScanSoft®
OmniPage® Pro to create text PDF providing
text extraction and indexing capabilities.
Refer to scanning requirements below.
Data submitter does not have to quality assure the
underlying OCR, however, more accurate text recognition in
the submitted PDF file will allow for increased utility by OPP
reviewers.
Avoid overuse of cell splits and joins in tables to avoid
conversion problems.
Do not use shading in tables as it may not convert
accurately.
• Third choice
Scan without OCR.
This option should only be used for
photographs, chromatograms, and any other
graphic-based data where use of OCR is
impractical.
This option produces a graphic-only PDF file and does not
allow for required text manipulation.
Scan Text and tables
Black and white 300 dpi minimum.
The greater the scanning resolution, the more accurate will be
any OCR process.
Scan handwriting
Black and white 300 dpi minimum.
Scan Color Photos
100 - 600 dpi, 24-bit RGB depending on nature
and purpose of photos.
If high resolution is critical, use 600 dpi but
attach as supplemental file.
To avoid the creation of very large files and the need for
users to scroll large photos, scan at the minimum resolution
needed to achieve an accurate rendition of the original. If
significant detail is required then use higher resolution.
Specifications for Creating PDF Version of Study Reports
Revision 2
-------
US EPA, Office of Pesticide Programs - Electronic Submission and Review
June 25, 2008
Format and Creation of PDF File
Scan Black and White
Photos
100 - 600 dpi, 8-bit gray scale.
If high resolution is critical, use 600 dpi but
attach as supplemental file.
See note for color photos above.
Scan Gels and
Karyotypes
100-300 dpi, 8-bit gray scale. Do not use
photographs.
Scan Plotter Output
Capture digitally or scan at 300 dpi.
Scan
Chromatography
300 dpi.
Adobe" Acrobat"
Distiller® Job Options
Use Agency supplied downloadable job options
file or manually configure job options using
Software Settings for the Creation of PDF Files
for Electronic Study Submission guidance
available on this web site.
This requirement applies to use of Adobe® Acrobat
®
Distiller in the creation of the study report .pdf file.
Security
Do not lock file in any way. Specifically select
the following settings:
Permissions:
$ Allow content copying and extraction
$ Comment authoring, form field fill-in or
signing.
Printing:
$ Fully allowed.
Goal is to allow reuse of PDF information and printing.
Note: Security options may change in the future.
Specifications for Creating PDF Version of Study Reports
Revision 2
-------
US EPA, Office of Pesticide Programs - Electronic Submission and Review
June 25, 2008
Format and Creation of PDF File
File Size
File Naming
Convention
- Study reports
File Naming
Convention
- Supplemental
Files/Review Aids
Page Size
Margins
Page Orientation
Page Numbering
No limit.
MRID.PDF
Example: 12345678.PDF
MRID is the eight digit number assigned to the
study.
MRID descriptive name . xxx
unless specific guidance exists for the specific
supplemental data type where .xxx is the
appropriate extension for the file type.
Example: 12345678 acute oral. xxx
8.5"x 11".
At least 1 " on all sides.
Use source document orientation.
Same as source document.
PDF has no limit on file size. But the PC on which someone
builds or reads the files can introduce constraints.
You must obtain a block of MRIDs from EPA before
preparing an electronic submission that includes one or more
studies. Contact Teresa Downs, (703) 305-5363,
downs.teresa@epa.gov
Refer to supplemental/review aids guidance for specific
information on naming of supplemental files and review aids.
Specifications for Creating PDF Version of Study Reports
Revision 2
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US EPA, Office of Pesticide Programs - Electronic Submission and Review
June 25, 2008
Format and Creation of PDF File
* Font Embedding
Electronic Signatures
Bookmarks - Study
table of Contents
Bookmark Hierarchy
Hypertext Linking
Link Supporting
Information
Embed all fonts including for Base 14 fonts.
Not implemented at present.
Create bookmark for each item in table of
contents of study report document.
Limit to no more than four levels within a single
study.
Yes. Use Inherit Zoom magnification setting.
Yes, when not on the same page. Link tables
and appendices to references in text.
Goal is to embed all fonts used in document to ensure correct
formatting, appearance, and printing of document. It is
recommended that the PDF be created on the same computer
on which the original source document was created so the
same non-proprietary fonts are available. Using the "when
embedding fails - cancel job" option will make it obvious
when font problems exist.
Do NOT use proprietary fonts. These can not be embedded
in PDFs. Acrobat will try to use a substitute font but this may
alter document format, appearance, and print.
Electronic submissions must include Certification with
Respect to Data Integrity pending development of Agency
policy and standards on electronic signature.
Follow OPP guidance for required bookmarks for specific
study types.
Consensus is that people get 'lost' when there are more than
four levels.
Link to details of problem items identified in the body of the
study report.
Specifications for Creating PDF Version of Study Reports
Revision 2
-------
US EPA, Office of Pesticide Programs - Electronic Submission and Review
June 25, 2008
Format and Creation of PDF File
* Link Style
Indexing
Open Dialog Box
Electronic
Supplemental
Files/Review Aids
* Chemical Structure
Information
Blue text/underline or outline box.
Not required at this time.
Use Bookmarks & Page. If no bookmarks, then
Page only.
See Supplemental Files/Review Aids guidance
documents.
Submit as Rdfiles, Sdfiles, or Molfiles.
If printed, paper version is being used as the source (scan &
OCR) then use a box surrounding the link. If the source
document is in electronic format, then use underlined blue
text which will remain blue after creating the PDF. In this
case, create the link with out any outline features.
This includes both the Document Property > Summary Data
of the PDF and Indexing using the Adobe ® Acrobat®
Cataloging capability.
Submit mechanistic and metabolic pathway data when either
a new chemical submission or additional data on existing
chemicals. Use any software capable of creating the
appropriate file type. OPP is using MDL® ISIS software for
review purposes.
* Indicates that there has been some change in the guidance from the previously posted version.
Specifications for Creating PDF Version of Study Reports
Revision 2
-------
US EPA, Office of Pesticide Programs - Electronic Submission and Review
June 25, 2008
Submission of PDF Study
Feature
Submission Medium
Where to Submit
Specification
Compact Disk (CD-ROM) or DVD.
Send via courier service to OPP physical
location:
Document Processing Desk (E-SUB)
U.S. EPA - Office of Pesticide Programs
Room S-4900
2777 South Crystal Drive
Arlington, VA 22202
Comments
Disk must be compatible with Windows 95 or higher.
Do NOT send via US mail. The irradiation procedures
currently used on Washington, DC mail will damage the CD-
ROM..
* Indicates that there has been some change in the guidance from the previously posted version.
Specifications for Creating PDF Version of Study Reports
Revision 2
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