E-Submission Guidance Updates

Updates to e-submission guidance including instructions for Dossier-formatted submissions.

For all e-submissions

1. All MRIDs for a specific 6-digit root MRID must be in the same zip file.

2. Each document must be submitted as a single file. This is directed mainly for large studies that typically, in paper format, would be split up into multiple physical volumes.

3. Do not include the same document in multiple zip files. Likewise, do not include a reference in the XML file to a document that is not physically included in the zip file. If a document supports multiple products, reference the document on the data matrix, transmittal, or other document (e.g. cover letter) as appropriate. e-Submission is not intended to provide cross-reference information and is merely a mechanism to get documents to the EPA.

4. There is a file size limit for the zip files. Restrict each zip file to less than 2 GB. If a submission will be larger than that size, submit two separate zip files each with its own xml file and corresponding documents.

5. If a CSF requires an “addendum”, include the addendum at the back of the CSF as part of the CSF file and submit as a single document.

6. Do not use “&”, “<”, and “>” in the xml file. Also, restrict characters to those in the UTF-8 character set. Typical examples of characters that are not part of the UTF-8 character set include ™, ®, ©, (M-dash), – (n-dash). Do not confuse the normal hyphen (allowed) with the M-dash and N-dash symbols (disallowed).

7. Study summaries that have a one-to-one relationship with the study do not require their own MRIDs but should reference the MRID of the study they are summarizing. Note the US_MD2 field (Document type) for these summaries will be “STP”. These summaries should be in MS Word file format (see item 6 under Dossier formatted submissions below).

8. If the study summary is a summary of multiple studies (one-to-many) then they may require their own MRID (see item 5 under Dossier formatted submissions below). They should be submitted as PDF files. If there is a desire to submit MS Word versions of these summaries (please consult with the appropriate regulatory for guidance on this), the MS Word files would be considered “summaries” of the parent study (in this case the PDF version) and should follow the one-to-one summary guidance (see item 7 above and item 6 under Dossier formatted submissions).

For Dossier-formatted submissions

1. Documents A, B, C, D, E, F, G, and H, are not considered “studies” and do not need to

have an MRID nor be formatted per PRN 86-5 requirements. Please include these

documents on the Transmittal and identify as “administrative”.

2. Document C can contain more than one label if multiple products are being applied

for/amended in the dossier. However, a separate file of the label specific to the product

that the zip file references must also be included in the package. If there are multiple

labels for that product (e.g. professional vs homeowner), each label should be in a

separate file.

3. The contents of Document I may be required to be submitted as studies and assigned

MRID(s). Please contact OPP if needing to submit Document I for specific instructions.

4. Document J will be a compilation of all CBI from the submission. Document J will be

considered a “study” document type (US_MD2), must have its own MRID, and be

formatted per PRN 86-5. At the present time, only one MRID can be associated with

each document. Because of this, OPP will reference Document J to the parent studies the

CBI was sourced from. The CBI may also reside as an appendix to each individual study

consistent with the paper document process.

5. Documents M and N - Tier II and Tier III summaries require MRIDs unless the

summaries are entirely summarization of the submitted studies. If any information is

included that is not part of the individual studies, the tier summary will require MRIDs

and be subject to PRN 86-5 requirements.

6. Robust study summaries (or Document L or Tier I) – summaries which are entirely a

summarization of submitted studies do not require MRIDs. These should be submitted

only in MW Word format and should reference the MRID of the parent study in the xml

file (DM_EPA_MRID).

E-Submission Guidance Updates

For all e-submissions

For Dossier-formatted submissions

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