US Environmental Protection Agency Office of Pesticide Programs Specifications for Creating PDF Version of Study Reports June 25,2008 ------- 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 Specification Comments Software Any word processing or desktop publishing software. 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. Page size 8.5" x 11". An A-4 source document is allowable provided the resulting PDF page size is set for 8.5" x 11". Margins At least 1" on all sides. Font Size/Style - Text of study report. 12 point Times New Roman 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. Font Size/Style B Tabular information 12 point Courier. 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 1 Revision 2 ------- 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 2 Revision 2 ------- US EPA, Office of Pesticide Programs - Electronic Submission and Review June 25, 2008 Format and Creation of PDF File Feature Specification Comments Printing Create PDF document after paper version passes 86-5. 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. File Format Adobe® Portable Document Format (PDF) - Version 1.4 or higher. PDF File Compatibility Adobe® Acrobat® 5.0 or higher. EPA staff will use Adobe® Acrobat® 5 (full program) to perform reviews. Software 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. Conversion to PDF Options. 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. • First choice Convert directly from electronic source document. This provides full indexing for text and tables. Specifications for Creating PDF Version of Study Reports 3 Revision 2 ------- 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 usedfor 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 4 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 Asencv supplied downloadable iob 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 5 Revision 2 ------- US EPA, Office of Pesticide Programs - Electronic Submission and Review June 25, 2008 Format and Creation of PDF File File Size No limit. PDF has no limit on file size. But the PC on which someone builds or reads the files can introduce constraints. File Naming Convention - Study reports MRID.PDF Example: 12345678.PDF MRID is the eight digit number assigned to the study. 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 File Naming Convention - Supplemental Files/Review Aids 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 Refer to supplemental/review aids guidance for specific information on naming of supplemental files and review aids. Page Size 8.5" x 11". Margins At least 1" on all sides. Page Orientation Use source document orientation. Page Numbering Same as source document. Specifications for Creating PDF Version of Study Reports 6 Revision 2 ------- US EPA, Office of Pesticide Programs - Electronic Submission and Review June 25, 2008 Format and Creation of PDF File ~ Font Embedding Embed all fonts including for Base 14 fonts. 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 Signatures Not implemented at present. Electronic submissions must include Certification with Respect to Data Integrity pending development of Asencv policy and standards on electronic signature. Bookmarks - Study table of Contents Create bookmark for each item in table of contents of study report document. Follow OPP guidance for required bookmarks for specific study types. Bookmark Hierarchy Limit to no more than four levels within a single study. Consensus is that people get 'lost' when there are more than four levels. Hypertext Linking Yes. Use Inherit Zoom magnification setting. Link to details of problem items identified in the body of the study report. Link Supporting Information Yes, when not on the same page. Link tables and appendices to references in text. Specifications for Creating PDF Version of Study Reports 7 Revision 2 ------- US EPA, Office of Pesticide Programs - Electronic Submission and Review June 25, 2008 Format and Creation of PDF File ~ Link Style Blue text/underline or outline box. 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. Indexing Not required at this time. This includes both the Document Property > Summary Data of the PDF and Indexing using the Adobe ®Acrobat® Cataloging capability. Open Dialog Box Use Bookmarks & Page. If no bookmarks, then Page only. Electronic Supplemental Files/Review Aids See Supplemental Files/Review Aids guidance documents. ~ Chemical Structure Information Submit as Rdfiles, Sdfiles, or Molfiles. 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 8 Revision 2 ------- US EPA, Office of Pesticide Programs - Electronic Submission and Review June 25, 2008 Submission of PDF Study Feature Specification Comments Submission Medium Compact Disk (CD-ROM) or DVD. Disk must be compatible with Windows 95 or higher. Where to Submit 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 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 9 Revision 2 ------- |