Department of Pesticide Regulation Logo 
Peter M. Rooney
Secretary for
Environmental
Protection

Department of Pesticide Regulation


James W. Wells, Director
830 Street - Sacramento, California 95814-3510 - www.cdpr.ca.gov

California State Seal
Pete Wilson
Governor

January 1, 1999

California Notice 99-1

TO: PESTICIDE REGISTRANTS AND DATA SUBMITTERS

SUBJECT: FORMAT GUIDELINES FOR ALL DATA SUBMITTED FOR PESTICIDE REGISTRATION IN CALIFORNIA

These guidelines specify format and organization of each data volume and include requirements for folders, covers and labels. Submissions that do not conform to these guidelines will be returned or held until they are prepared for processing. The Pesticide Registration Branch (PRB) no longer has facilities to hole-punch and bind submissions. When inappropriately bound submissions are received, the sender is given their choice of remedies: re-send the data in the correct format; send someone to collect the data and have it bound correctly before returning it to PRB; or pay for PRB to return the submission.

The following guidelines are based on the federal regulations, 40 CFR, Section 158.32, with some specific prohibitions and recommendations for California only. All submissions that include data should have the data prepared according to these guidelines. Do not bind applications for registration, labels, proof of federal registration, or letters authorizing use of another firm's data. Bind only the data and copies of your cover letter.

MAILING / SHIPPING ADDRESSES:
If you are using the U.S. Postal Service, please send your submission to:


Pesticide Registration Branch
830 K Street, 9th St. L/L
Sacramento, California 95814-3510

If you are using any other carrier (U.P.S., Federal Express, etc.), please send your submission to:


Pesticide Registration Branch
1116 9th Street, L/L
Sacramento, California 95814

FORMAT SPECIFICATIONS FOR DATA SUBMITTED TO CALIFORNIA:

. ALL DATA MUST BE APPROPRIATELY BOUND!

. Submit only one complete copy of the data.

. Use uniform 8-1/2 by 11 inch white paper, printed in black ink, with high contrast and good resolution.

. Do not include frayed or torn pages, carbon copies, or copies in other than black ink.

. Be sure that photocopies are clear, complete, and fully readable.

. Be sure that all pages are present, numbered, and in order.

. Do not include oversized computer printouts or fold-out pages.

. If the original report is not in English, provide a complete English translation.

. Separate studies or sections of studies by labeled tabs. Identify each study by the U.S. Environmental Protection Agency (U.S. EPA) guideline reference number and Master Record Identification Number (MRID).

. For large submissions, include a table of contents, or itemize the volume titles in your cover letter.

. Your cover letter should address at least the following points:
1. Name and address of data submitter(s);
2. Reason why this package is submitted;
3. Date of this submission;
4. List of submitted studies by title.

. Place a copy of the cover letter in the very front of each volume of the submission. The original cover letter should be bound in the front of the first volume and copies placed in all other volumes.

. Multiple small studies of similar type may be bound together in one volume with tabs and divider pages between each study (i.e., acute toxicology studies, or efficacy studies). Include a table of contents and bind to a maximum thickness of two inches.

. Any studies conducted on other than pesticide active ingredients or product formulations (i.e., inert ingredients, precursors, impurities, degradation products, etc.) must be clearly identified as to the kind of study (i.e., acute oral LD50), the compound on which the study is conducted, and the reason for its inclusion in the submission (i.e., to support registration of product XYZ, EPA Reg. No. 123-456-AA).

. If your submission is in response to a data call-in, reevaluation, risk assessment, or is an adverse effects disclosure, please label it prominently, identifying the specific reason for the submission. Please do NOT include any data in this submission that does not relate to the specific purpose of the submission.

. If your submission is a "courtesy copy" to PRB of data you submitted to U.S. EPA, please include a copy of your cover letter to U.S. EPA along with your own cover letter to PRB, telling us what product(s) or active ingredient(s) this submission is to support.

. If a single study consists of several volumes, clearly identify each volume in order (i.e., 1 of 5, 2 of 5, etc.) and put a copy of the cover letter in the front of each volume.

RECOMMENDED FORMAT FOR EACH STUDY VOLUME:

  • Front cover;
  • Copy of cover letter to PRB;
  • Title page;
  • Abstract (no confidential information);
  • Introduction;
  • Materials and Methods;
  • Results and Discussion;
  • Summary of study;
  • Data, tables, appendices;
  • Analytical methods, feed analyses, etc.;
  • Back cover

SPECIFICATIONS FOR FOLDERS AND COVERS:

Please do NOT use the following: plastic or vinyl covers of any sort (they tear, slide, and have a short shelf-life); 2-, 3-, or 4-ring binders; folders with pockets, folders with comb-type, spiral-type or "velo"-type bindings (they do not allow insertion of additional pages); construction paper covers; plain paper covers.

PRB Library staff recommend the following:
. "ACCO-PRESS" (or equivalent) pressboard folders (NOT plastic or vinyl) with holes punched in the left-hand 11-inch side of the pages. Have folder prongs open in the front of the volume and please do not put tape on the prongs or bend them back.

. If a study exceeds two inches in thickness (about 400 pages), PLEASE divide it into the appropriate number of ACCO-PRESS type folders with a copy of the cover letter in each. Allow at least one-half inch on length on each of the ACCO-PRESS folder prongs to allow for addition of internal documents.

. Please have holes punched in the left side of the pages with sufficient margins that the pages do not tear out easily.

SPECIFICATIONS FOR LABELING:

Please clearly label each volume, including at least the following information: name of data submitted, product brand name and EPA Registration number or active ingredient name, type of data in the volume and study title, and number of volumes in the submission (i.e., 1 of 27, 2 of 27, etc.).

SUBMISSIONS NOT REQUIRING BINDING:

. An application for registration with labels, cover letter, proof of federal registration and letter of authorization for use of data on file. NO DATA SUBMITTED.

. A request for registration of an amended label with no data submitted.

. A request for registration of an alternate or revised formulation with no data submitted.

. Copies of correspondence, material safety data sheets (MSDS), or technical bulletins.

. Fewer than 10 pages of data to be inserted into a specific volume of data previously submitted. Identify the product or active ingredient, the volume number, and the study record number in your cover letter.

Your cooperation in following these guidelines is very much appreciated. If you have any questions regarding these guidelines, you may call Ms. Jacquelyn Rivers at (916) 324-3549.

Sincerely,



original signed by Barry Cortez


November 23, 1998


Barry Cortez, Chief
Pesticide Registration Branch
(916) 445-4377

Date


California Environmental Protection Agency