Pesticide Registration

E-submission frequent questions for labels

  1. Q: What are the advantages to submitting e-labels?

    A: Having labels available in electronic format will enable EPA to identify label changes, compare proposed text to required text and review labels faster than using paper alone. Bottom line: E-labels will result in more efficient reviews with increased accuracy and reduced turnaround time.
     
  2. Q: If I want to try out e-labels, how do I get started?

    A: Read the overview and download the latest technical guidance on electronic submission from EPA's website. In additions to the word processing or graphic layout software you currently use to create your draft label you will need software to convert the label into a portable document format (.pdf) file. Ensure that the software you use can match the technical requirements outlined on the website. You will also need a drive that can write files to a CD-ROM.
     
  3. Q: If I'm submitting my first e-label, should I also submit the last accepted label so EPA can compare it to my proposed label?

    A: No, submit only a .pdf of your proposed label. Even with one e-label there are several tools available that can make the review easier. Once the first e-label has been reviewed and stored by EPA, subsequent submissions can take advantage of the electronic comparison tool.
     
  4. Q: I used to send one copy of a "marked-up" label showing the changes since my previous label submission. Should I still do this? Which version of the label should I use to create the .pdf (the "clean" or the "marked-up" version)?

    A: Although you may continue to do so if you wish, it is no longer necessary to submit one marked-up version of your proposed label showing the changes since your previous label submission. More importantly, you should use the "clean" version without any editing marks to create the electronic .pdf you submit to EPA.
     
  5. Q: I also have my cover letter, forms, and certificate in electronic format. Should I include these in .pdf of the label?

    A: The label should be in a file by itself; do not include any other letters, forms, or other administrative paperwork in the same .pdf file. It is not necessary to send electronic copies of the administrative papers at this time (although you may if you wish as long as they are in a separate file, not with the label). Administrative paperwork (cover letter, SF 8570-1, data compensation, etc.) may be included on the same CD-ROM as the e-label. However, submit separate CD-ROMs for any e-data studies and e-Notice of Filing since they are sent different places for processing and filing. [Note: This may change in the future when a full electronic submission system is developed.]
     
  6. Q: The technical guidance say to "embed the fonts" in the .pdf. What does that mean and how do I do it?

    A: There are thousands of fonts and the computer needs instructions on how to display or print each one. By default, when you create an e-label on your computer the .pdf files will include the name of the font(s) used by will leave the instructions for drawing the letters up to the receiving computer. That's fine if both computers have the same font instructions but if the receiving computer does not have a certain font it will try to substitute a similar font. Sometimes that works but often it changes the spacing and layout of the label. In the worst case, a character may not display correctly thus introducing errors into the label. "Embedding" the fonts means to include the instructions for drawing the letters in the .pdf file so that any computer receiving the file can display and print it correctly. If using Adobe Acrobat to product the .pdf you embed the fonts by looking under Settings, Job Options, Fonts. Check the box near the top that says "Embed all fonts" and do not check the next box dealing with subsetting the fonts used. As an added precaution, under "When embedding fails" select "Cancel job." Tip: Create the .pdf on the same computer on which the original document was created so that same fonts are available for embedding.
     
  7. Q: I'm using Adobe Acrobat 5 but my .pdfs don't come out in the latest version as specified by EPA. What can I do?

    A: Acrobat may be defaulting to create an older version of .pdf. You'll need to intentionally tell it to create the latest version. If using Acrobat Distiller to produce the .pdf you can set the version by looking under Setting, Job Options, General, Compatibility. Select "Acrobat 5.0 (pdf 1.4)."
     
  8. Q: Is there an easy way to set all the .pdf controls that EPA requires?

    A: Yes. If using Adobe Acrobat to produce the .pdf do the following: (1) Download the file "EPA Label Print.joboptions" from the EPA website and then put in on your computer under "C:\Program Files\Adobe\Acrobat 5\Distillr\Settings;" (2) In Acrobat Distiller select "EPA Label Print" and the job option when creating you .pdf file. This will set everything except the security settings; and (3) In Acrobat Distiller set the security settings by looking under Permissions select "Allow content copying and extraction," under Changes Allowed select "Comment authoring, form field fill-in or signing," and under Printing select "Fully allowed."
     
  9. Q: I simply named the e-label file "proposed label.pdf." Is that OK?

    A: No. You MUST use the file name format specified by EPA in the technical guidance. The computer automatically stores the label and displays related information from the EPA tracking database based on this file name. If you created the e-label under the wrong name you do not need to recreate it, just rename it using Windows Explorer.
     
  10. Q: Can I send the e-label on a floppy disc?

    A: No. You must use a CD-ROM.
     
  11. Q: What kind of CD-ROM should I use?

    A: To ensure that the registrant's files cannot be altered once written, it is recommended that you use a CDR (write once) type CD-ROM rather than a CDRW (rewritable) type.
     
  12. Q: How do I submit the e-label to EPA?

    A: Submit all the usual paperwork (cover letter, EPA Form 8570-1, et al.), five paper copies of the label, a .pdf file of the label on a CD-ROM, and a certificate (download from EPA website) stating that the paper and electronic versions of the label are the same. Send this via courier; do not send via U.S. mail since the current irradiation procedures used for some Washington, DC mail will damage the CD-ROM. Include the electronic submittal flag (E-SUB) in the address as follows: Document Processing Desk 7502P (E-SUB) U.S. EPA - Office of Pesticide Programs 2777 South Crystal Drive Arlington, VA 22202
     
  13. Q: I've been sending e-labels for awhile now. I'm in a rush this time and wanted to get my latest amendment in the mail to EPA quickly. Can I just skip the e-label and send only the paper?

    A: Once you start sending e-labels it is best to keep it up. The biggest time-save with e-labels will be the ability to use the computer to quickly identify changes since the last EPA reviewed label. This comparison tool requires two e-labels. Once started, if you skip sending an e-label you're back to square one and the comparison tool cannot be used until EPA again has two e-labels. Taking a few minutes to put your label on a CD-ROM in .pdf format should help get your label back faster.
     
  14. Q: My last stamped label was accepted with comments and I've submitted several notifications since then. Can I still submit an e-label with my next label amendment?

    A: Yes. The computer comparison will simply pick up the old EPA required changes and you notification changes in addition to your new proposed changes. It would be helpful if your cover letter mentioned the dates of the last label(s) if accepted with comments or notifications so the reviewer can quickly look them up and verify the changes.

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