Department of Pesticide Regulation Logo

Paul E. Helliker Director

Department of Pesticide Regulation


   
   
   
   
  California Notice 2001-1

California State Seal
Gray Davis
Governor

Winston H. Hickox
Secretary, California
Environmental
Protection Agency

TO: PESTICIDE REGISTRANTS AND DATA SUBMITTERS

SUBJECT: Format Guidelines For 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. If inappropriately bound submissions are received, the sender has a 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 for the Pesticide Registration Branch:
If you are using the U.S. Postal Service, please use:

Department of Pesticide Regulation
Pesticide Registration Branch
P.O. Box 4015, 1001 I Street
Sacramento, California 95814-4015

If you are using any other carrier (U.P.S., Federal Express, etc.), please use:

Department of Pesticide Regulation
Pesticide Registration Branch
1001 I Street
Sacramento, California 95814-2828

FORMAT SPECIFICATIONS FOR DATA SUBMITTED TO PRB:

· 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 being submitted to California;
3. Date of this submission;
4. List of submitted studies by title.


· Place a copy of the cover letter in the 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 (e.g., several efficacy studies). Include a table of contents and bind to a maximum thickness of one and a half inches (about 345 pages).

· Any studies conducted on other than pesticide active ingredients or product formulations (e.g., inert ingredients, precursors, impurities, degradation products, etc.) must be clearly identified as to the kind of study (e.g., acute oral LD50), the compound on which the study is conducted, and the reason for its inclusion in this submission (e.g., 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 the 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 very short shelf-life);

· 2-, 3-, or 4-ring binders;

· folders with pockets,

· folders with comb-type, spiral-type or "velo"-type bindings (these do not allow the insertion of additional pages);

· construction paper covers,

· plain paper covers.

PRB library staff recommends 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 one and a half inches in thickness (about 345 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 of length on each of the ACCO-PRESS folder prongs for the addition of internal documents.

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

SPECIFICATIONS FOR LABELING:

Please clearly label each volume, including the following information:

· name of data submitter,

· product brand name and U.S. EPA Registration Number or active ingredient name,

· type of data in the volume (e.g., chemistry, efficacy),

· study title (e.g., acute oral LD50 in rats), and

· number of volumes in the entire submission (e.g., 1 of 27, 2 of 27, etc.).

If the submission is in response to a specific PRB request, be sure to include the reason for submission on the label (e.g., SB-950 data call-in).

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 ten 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 if very much appreciated. If you have any questions regarding these guidelines, you may call Ms. Jacquelyn Rivers at (916) 324-3549 or you may e-mail her at JRivers@cdpr.ca.gov.

Sincerely,


original signed by Barry Cortez


January 1, 2001


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

Date

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1001 I Street - P.O. Box 4015 - Sacramento, California 95814-4015 - www.cdpr.ca.gov
A Department of the California Environmental Protection Agency