Regulatory Directive: Organizing and Formatting a Complete Submission for Pest Control Products

11 April 2003
ISBN: 0-662-32856-6
Cat. No.: H113-3/2003-1E-IN
(DIR2003-01)

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Comprehensive Summary (Appendices not included)

In February 1998, the Pest Management Regulatory Agency (PMRA) produced Regulatory Proposal PRO98-02, Organizing and Formatting a Complete Submission for Pest Control Products. The information contained in the proposal was provided to assist applicants to prepare complete and properly formatted and organized submissions when applying to register new pest control products or to amend existing ones. Complete and well-organized submissions prepared according to this guidance are more likely to pass the screening stages within the PMRA and therefore contribute to the increased efficiency of the regulatory process. The PMRA received comments on the proposal and carefully considered comments from all respondents.

This directive, which is an amended version of PRO98-02, includes clarification and additional information related to definitions, index requirements, pre-submission consultations, letters of screening deficiencies, number of copies of information required, comprehensive data summaries and Organisation for Economic Co-operation and Development formats. Further amendments have been made to data requirements as a result of the publication of regulatory directives for product chemistry and residue chemistry.

This regulatory directive replaces PRO98-02 and regulatory directives DIR93-01, Organization of Data for Technical Active Ingredients, and DIR93-03, Organization of Data for End-Use Products.

Note: In order to provide minor clarification in Appendix I and concerning the use of Appendix II, the February 14, 2003 version of this document has been revised.

Foreword

This document explains the process for organizing and formatting a complete submission. It describes procedural, organizational and formatting improvements aimed at:

  • increasing the efficiency of submission processing; and
  • preparing the Canadian pesticide industry and the Pest Management Regulatory Agency (PMRA) for international harmonization of registration standards and processes.

Canada is working with countries within the Organisation for Economic Co-operation and Development (OECD), including the United States, on harmonization activities aimed at developing international standards for common submission formats and data requirements (refer to Appendix IV). The PMRA accepts submissions formatted according to the Guidelines and criteria for industry for the preparation and presentation of complete dossiers and of summary dossiers for plant protection products and their active substances in support of regulatory decisions in OECD countries dated March 2001, found on the Organisation for Economic Co-operation and Development web site http://www.oecd.org/ or at http://www.eddenet.ca, as well as through links via the Pest Management Regulatory Agency web site http://www.hc-sc.gc.ca/pmra-arla. This OECD format contains a crosswalk of numbering systems (e.g., OECD, European Union, United States (U.S.), Canada, Japan, Australia) for organizing and indexing supporting data. The PMRA will also accept applications for microbials and pheromones submitted in OECD format as guidance is developed by the OECD.

There are major benefits, outlined below, to be gained in following the processes set out in this document.

  • The numbering system for organizing and indexing supporting data explained here is important to the use of the new OECD format.
  • The system for determining data requirements based on use-site categories (USCs) should help applicants put together a complete submission package containing all the required studies that will pass more efficiently through the registration process. This will reduce the cost to industry by allowing a regulatory decision to be made for products sooner.
  • Today, the electronic environment is being utilized to a greater extent with the use of electronic indices, labels and comprehensive summaries. Downloading information onto a diskette requires little effort on the part of applicants, but is important to the PMRA, as the receipt of information in electronic format has been shown to reduce the time necessary to process and evaluate the information. Electronic submissions will also pave the way for new uses of information technology being developed by the PMRA and other international agencies.

The information contained in this document has been shared with industry, when requested, and most applicants have submitted applications that conform with these guidelines. From the date of publication of this revised document, the PMRA will require applicants to organize and format their submissions according to these standards or the OECD standards indicated above. Following initial verification, submissions that do not conform with the requirements for organizing and formatting will be found deficient. The applicant will be asked to address these deficiencies before the submission is screened further.

Table of Contents

1.0 Introduction

A number of efficiencies were implemented with the establishment of the Pest Management Regulatory Agency (PMRA) and the consolidation of various agencies responsible for pesticide regulation. One such efficiency was the comprehensive screening of submissions early in the registration application process. Submission screening contributes to a more efficient regulatory system by providing correctly formatted and complete submissions for efficient review. Complete and correctly formatted submissions also allow for improved handling, tracking, storage and retrieval. Screening also facilitates the identification of deficiencies to applicants early in the review process.

The PMRA Regulatory Proposal PRO96-01, Management of Submissions Policy, dated June 7, 1996, outlines submission categories and the submission management process, including submission screening. This regulatory directive describes the procedures and criteria for submission screening in more detail, and gives more complete direction on the organization of a submission and its supporting information package to companies that intend to apply to register new products, to amend existing registered products or to carry out research with new or currently registered pest control products. While this directive serves as a general guide for organizing and formatting most submissions, applicants should contact the PMRA for specific directives relating to biopesticides, specifically microbials and pheromones.

2.0 General definitions

Category A: includes submissions to register new technical grade of active ingredient (TGAI) or integrated system products (ISP) (not previously registered in Canada) and their related end-use product(s) (EPs), manufacturing-use products (MAs) or major new use (defined as the addition of a new use-site category to the use pattern for a specific registered TGAI), or to establish an import maximum residue limit(s) (MRL) for a new active ingredient. These submissions are usually accompanied by a significant amount of data supporting safety and value, and include URMURs (user requested minor use registrations) and joint reviews. Besides traditional agricultural chemical and biocidal active ingredients, this category also applies to adjuvants, biopesticides including microbial pesticides, pheromones, and seed treatments for export only. Refer to Regulatory Note REG2003-01, Guidance on Selecting the Correct Category for Pest Control Product Submissions, for more details.

Category B: includes submissions to register new pest control products (must contain an active ingredient that is currently registered for use in Canada) or to amend existing products. These include changes in product chemistry for the TGAI or ISP, changes in product chemistry for the EP or manufacturing concentrate (MA), changes in product labelling, the conversion or extension of temporary registration and the addition of import MRLs for previously assessed TGAIs. These submissions are supported by a partial database (not all data codes (DACOs)) as the PMRA has some of the data on file from previous registrations, or may require scientific assessment by the Occupational Exposure Assessment Section (OEAS), for example. These submissions are less complex and take less time to review than Category A submissions. Refer to REG2003-01 for more details.

Category C: includes submissions with no or reduced data requirements for new or amended registrations requiring minor label or formulation reviews, such as product registrations based on precedent. Refer to REG2003-01 for more details and Regulatory Note REG2002-04, Category C submission Efficacy Reviews.

Category D: includes submissions to register or to amend products within particular programs, for example, Import for Manufacture and Export Program (IMEP), own use import (OUI), master copy, private label, user requested minor use label expansion (URMULE), renewals. The current versions of regulatory documents concerning these special programs are listed in Appendix II. Refer to REG2003-01 for more details.

Category E: includes submissions for research permits (refer to Regulatory Directives DIR98-05, Chemical Pesticides Research Permit Guidelines, and DIR97-02, Guidelines for the Research and Registration of Pest Control Products Containing Pheromones and other Semiochemicals, and Regulatory Proposal PRO93-05, Research Permit Guidelines for Microbial Pest Control Products), for new TGAIs and new use(s) of registered TGAIs, as well as research notifications carried out in Canada. Exemptions from data requirements are based on the size and location of treated areas. Refer to REG2003-01 for more details.

Use-site categories (USCs): for conventional chemical pesticides were developed to group use-sites with common data requirements into specific categories. For definitions of USCs, refer to Appendix III.

Data codes (DACOs): are numeric codes that are used to identify the individual scientific studies for each USC. Refer to Appendix IV for a complete list of DACOs.

DACO tables: list data requirements for registration of a product. These are available for the product types occurring in the 33 Use-site Categories for conventional chemical pesticides. DACO tables have been developed for other product types such as pheromones, establishing import MRLs, Category B submissions, and so on. DACO tables are to be posted on the PMRA web site; in the interim, tables are available upon request. Refer to Section 5.1 for more details.

Reduced-risk pesticides: in May 2002, the PMRA introduced an initiative whereby the North American Free Trade Agreement (NAFTA) Joint Review Programs for Reduced-Risk Pesticides will be extended by the PMRA to include submissions made to the PMRA only. The program is designed to encourage pesticide manufacturers to apply for Canadian registration of reduced-risk products including those that are currently available in the U.S. Canada will use the same criteria as the U.S. Environmental Protection Agency (EPA) to determine eligibility of chemicals for the reduced-risk program and recognize the U.S. EPA's biopesticide designation, thus further harmonizing the respective approaches of the two countries. Through this program, the PMRA will also commit to shorter review timelines for products that have been shown to qualify as reduced-risk chemicals or biopesticides. Refer to Regulatory Directive DIR2002-02 The PMRA Initiative for Reduced-Risk Pesticides for more details and guidance on preparation of submissions to the PMRA.

Notification/non-notification: there are three ways to make amendments to currently registered products: (a) changes that require review and approval through an amendment; (b) changes that are acceptable when the PMRA has been notified in writing by submitting a notification letter; and (c) changes where the PMRA does not need to be informed (non-notification). Refer to Regulatory Directive DIR2001-04 Notification/ Non-notification for more details and guidance on notifiable and non-notifiable changes to currently registered products acceptable to the PMRA.

3.0 Presubmission consultations

It is recommended that applicants for a Reduced-Risk Pesticide, Joint Review or URMUR, and those making a Category A submission or an electronic submission, contact the PMRA and arrange for a pre-submission consultation. Please refer to Regulatory Proposal PRO2000-03 "Single Window" for inquiries to the Pest Management Regulatory Agency or to Updated procedures for joint review of microbials and semiochemicals or Updated procedures for joint review of chemical pesticides for guidance. Before contacting the PMRA, please visit the Pest Management Regulatory Agency websites (http://www.hc-sc.gc.ca/pmra-arla or http://www.eddenet.ca), which contain all relevant guidance documents and information pertaining to such applications. An applicant may also contact the PMRA's Information Services for clarification of individual points before submitting any other type of application, to ensure that the submission meets standards for format, completeness and quality.

4.0 Submission verification

Within seven days of receipt, all submissions are verified to ensure that non-data elements such as covering letter, application form, fee form and fees (if required) (refer to detailed list in Appendix I) have been provided to support the application. Deficiencies result in a submission being returned to the applicant at the applicant's expense. An applicant whose submission is verified is provided with an acknowledgement card that includes the submission number. This number should appear on all correspondence dealing with that submission sent to the PMRA. Once verified, submissions are forwarded for screening.

5.0 Submission screening process

Submissions are screened in more depth for required elements, including data and non-data components, forms and various letters of documentation, as well as for completeness, proper formatting and organization according to the PMRA, DACO or OECD guidance number. Scientific validity of data is not assessed by Submission Screening. If no deficiencies are identified, the submission is forwarded to the relevant section for scientific review.

5.1 Use-site categories and DACO tables

Data required to support an application to register a new product, amend an existing one or conduct research with a pest control product depend on the nature of the product (chemical or microbial, for example), the purpose of the product (IMEP, for example) and where the product will be used (use-site) (on food or in water, for example). All possible use-sites for pest control products have been grouped into a series of 33 use-site categories (USCs) based on similar data requirements. For each USC, a DACO table has been prepared that lists required (R) and conditionally required (CR) studies. Each study in the table is identified by a numeric data code or DACO. DACO tables for some USCs are posted on the PMRA web site; others are available from the PMRA upon request. These DACO tables were developed from existing guidelines and practices and do not establish new data requirements. Refer to Appendix III for a list of USCs for conventional chemical pesticides and their definitions. In addition to DACO tables based on use-sites, tables are also under development for certain product types (such as adjuvants and seed treatments) and submission categories (Category B) and, if completed, may be obtained from the PMRA upon request.

Certain Category A submissions (A1.1, A1.2, A3.2) would require that virtually all of the data outlined in the DACO table for the relevant use-site categories be attached. For other submissions (the others within Category A, such as A4, major new use, and Category B submissions), the requirements for the data that must accompany the submission may be less than that in the relevant DACO table, as the PMRA may already have some of the needed data on file from earlier registrations. Whether the PMRA can use data on file depends on which company has submitted it and what access subsequent applicants have to it: if the applicant is not the owner of the TGAI used in the product, then a letter of confirmation of supply of TGAI is required and possibly a letter of authorization from the TGAI owner.

Data submitted should also include information that may indicate adverse or deleterious effects on human health and the environment. If foreign reviews, such as EPA Data Evaluation Reports, are available, it would be beneficial to submit them with the application.

5.2 Evaluation templates

Evaluation templates have been developed using the DACO tables that identify the R and CR studies for particular USCs. Evaluation templates are used to review the scientific studies that are submitted to support applications to register pest control products. These templates capture specific data components and record the reviewer's conclusions and rationales that are based on each data set. Executive summaries from templates are used to create an overall science monograph (a review document) on which the regulatory decision is based.

The PMRA encourages the use of the evaluation templates by study directors during the studies and the preparation of study reports. The level of detail, however, should be the same as would normally be included in a study report. Their early use provides significant benefits to PMRA evaluators and industry, and results in consistency of content and format that facilitates the evaluation process.

Note: The PMRA recognizes that the study and preparation period for a new pesticide submission can require a number of years. To facilitate the use of templates at the early stages of study development and report preparation, the PMRA will accept draft or older versions of approved templates even if newer versions are available at the time of the actual submission to the PMRA. The use and submission of draft or older templates will not exempt the submission from additional data requirements that are identified in the latest templates and regulations, for example. The PMRA strongly recommends that registrants check for and adopt new templates during the preparation of a submission.

To facilitate their use, identical versions of the evaluation templates are available in either WordPerfect or MS-Word format on the web at http://www.eddenet.ca. The templates are listed under their respective Divisions and represented in the lists by the heading ".wpd" (WordPerfect format) and ".doc" (Word format).

Note to Word users: Once completed, the Word templates must be converted to (saved as) "portable document format (PDF) normal" to ensure that they can be accessed and used by PMRA evaluators; do not submit them as Word files.

Data that is not included with a study should not be added via the evaluation template. Additional data should be submitted as an attachment. Refer to Section 6.6 for information on organizing evaluation templates.

5.3 Elements of a complete submission package

Only complete submissions containing all of the required elements will be considered for review by the PMRA. A submission is normally composed of a covering letter, an application form, the fee and supporting information. The supporting information may comprise a product specification form, various letters of support or authorization, draft label, index of supporting scientific data or studies, and the scientific data. Please refer to Appendix I for a list of the elements of a complete submission package. These elements are either R or CR depending on the purpose of the submission and the site or location of use of the product. For all submissions, all data requirements identified as R, as well as applicable CR data for a particular USC, must be addressed with appropriate studies or information, references to previously submitted data, or requests for waivers.

Applicants are encouraged to include in their submission a letter allowing regulatory agencies to discuss submissions and share reviews (monographs) with regulatory authorities in other countries, to facilitate international harmonization and work sharing.

5.4 Electronic submission of information

The PMRA's electronic submission capability is named the EDDE (Electronic Dossier, Delivery, and Evaluation) system. EDDE provides electronic support for the registration process. It is the key to efficiency gains for both industry and the PMRA. EDDENet, PMRA's secure, online pilot registration site, supports the EDDE capability (http://www.eddenet.ca). The PMRA has also provided four guidance documents to assist registrants with an electronic submission capability: Part I, which provides an overview (Regulatory Note REG2001-06, Guidance to applicants for preparing electronic submissions Part I: overview), and Parts II, III and IV (EDDE2001-01, -02, -03), which provide more detailed information and describe how registrants may participate in joint PMRA-industry electronic pilot projects. Additional detail is available and registrants interested in joint PMRA-industry pilot projects are encouraged to request a pre-submission consultation meeting.

Certain elements of a submission, such as the data index, product labels and comprehensive data summaries (CDS), must be submitted electronically on a 3.5" diskette or CD in PDF normal format, unless specified otherwise. If the applicant wishes to make a fully electronic submission, with all previously mentioned elements and all forms, letters, data and other items, the requirements are the same. An applicant wishing to submit information in a different electronic environment is responsible for confirming that no text loss or format changes have occurred as a result of the PDF conversion. When submitting a diskette or CD, applicants must include a statement in the covering letter certifying that the diskette or CD, to the best of their ability, is virus-free and that the information contained in the diskette or CD is a true and accurate duplication of the submitted paper copies. Any diskette or CD found to contain a virus will be returned to the applicant. For more details on formatting, refer to the sections pertaining to the specific type of information to be submitted, for example, index or label. Only one (1) paper copy of the complete dossier is required when submitting a fully electronic version.

Full instructions on how to use this mechanism are provided on the Pest Management Regulatory Agency web sites, http://www.hc-sc.gc.ca/pmra-arla.

The applicant will need:

  • a computer (PC: 486 processor or more / Mac: G3 and up with OS 8.6 or more)
  • an Internet browser such as Netscape or Microsoft Explorer
  • Internet access through an Internet service provider
  • Adobe Acrobat 4.0 or higher software. This is available from http://www.adobe.com.

5.5 New technical grade of active ingredient or integrated system product and related end-use product

The data required to support a new TGAI or ISP and related EPs are determined according to the DACO table for the appropriate USC. Since the data requirements for an ISP are the same as those for a TGAI, separate references to ISPs will not be made throughout this regulatory directive. Separate applications must be made for the TGAI and each EP, including separate indexes for the TGAI and each EP along with the required data for each. A submission to register a new TGAI (Category A submission) must be accompanied by a submission to register a related EP(s). When more than one company is involved, it is the responsibility of those companies to coordinate the concurrent submission of the TGAI and the EP application packages to ensure that they are received by the PMRA at the same time.

5.6 Manufacturing concentrate

Defined as a product containing a registered technical active ingredient(s) and formulant(s) intended for further reformulating or repackaging into EP(s).

In general, the data required to support an application to register an MA are as follows:

  • Part 0 Index
  • Part 1 Label
  • Part 3 Chemistry requirements set out in Regulatory Directive DIR98-03, Chemistry Requirements for the Registration of a Manufacturing Concentrate or an End-Use Product Formulated from Registered Technical Grade of Active Ingredients or Integrated System Products.
  • Part 4 Toxicology as required for an EP

For more specific information on data organization refer to Section 6.1 below.

5.7 Major new use

A major new use is defined as the addition of a new use-site category to the use pattern for a specific registered TGAI. An application to amend the TGAI to register the major new use must be accompanied by an application to register or to amend a related end-use product. The data required to support a major new use for a currently registered TGAI and related EP(s) are determined according to the DACO table for the appropriate USC. For these Category A submissions, data previously submitted in support of the TGAI or related EPs that address data requirements for the major new use do not need to be resubmitted, but must be cited in the index (refer to Section 6.1, Part 0, Index). The applicant must indicate in writing, by means of a letter of access or letter of confirmation of supply of TGAI, whether or not the PMRA may access that data. Separate indices should be submitted for the EP (major new use) and TGAI.

5.8 Tailgate submissions

Defined as a submission for a new or existing product for which a current submission is open, past screening and awaiting a regulatory decision. A tailgate submission cannot be reviewed until the previously submitted application has been accepted or proposed for registration. For example:

  1. Category B submission for amendment to formulation when Category A decision for same formulation not finalized;

  2. application for a new similar product based on an EP not yet registered and containing a TGAI not yet registered, with no PCP numbers assigned and no certificate issued; or

  3. applications for new uses or tertiary amendments awaiting other decisions on current open submissions.

Tailgate submissions delay the processing of the original submission by causing the review to cease and refocus to encompass the amendment. For example:

  1. changes in formulations or rates affect risk assessment because they require repetition of the review and risk assessment activities in numerous scientific disciplines, such as chemistry, occupational and food exposure, formulants issues;

  2. adding new uses or rates would require that parts of the review be redone: efficacy, exposure, environment and residue chemistry and all risk assessments.

Currently, tailgate submissions are identified at the screening stage. Once a tailgate submission is identified, the following options are given to the applicant:

  1. withdraw the tailgate submission and resubmit when the precedent submission is approved;

  2. maintain the tailgate submission but combine it with the precedent submission (adopt its category status) and reset the timelines for the precedent submission to start at the time of the tailgate submission; or

  3. screen and delay: that is, allow tailgate submission, perform preliminary screen and delay processing within the PMRA until the original submission is accepted for registration (proposed pilot project); during the delay status, any changes in scientific approach or new policies will apply to the submission in delay.

5.9 Responses to letters of screening deficiencies

A submission found to be deficient at the screening stage will result in a letter of screening deficiencies being sent to the applicant. All the deficiencies must be addressed in one response from the applicant, and any supporting information or data must be submitted together with the response in one consolidated package. It is not acceptable to address only some of the deficiencies in an initial response and then address the remainder at a later date. Where the submission for the TGAI is supported by a submission for an EP, as with new TGAIs, the deficiencies for both the TGAI and the EP must be addressed in the one response and any supporting information or data submitted with the response.

Each deficiency must be addressed in the response. Failure to address all the deficiencies adequately will result in the withdrawal of the submission. The submission number will no longer be valid. An applicant may resubmit the package, once the deficiencies have been addressed, as a new submission.

When deficiencies occur within more than one data part, the responses for each data part must be submitted in a separate binder, since each part is reviewed by a different division or section within the PMRA. Additional information can be added to the binders originally submitted, provided that there is adequate space. Alternatively, new binders can be submitted containing the responses. These binders should be given a new consecutive volume number, continuing from the numbers of the original package. Note that two copies of the information are always required, each in its own binder.

The index should be updated with an adequate number of copies included in the response. It is not necessary to replace the entire index: modifications and additions will suffice.

6.0 Organization of supporting data

Supporting data are organized into eleven general parts, as outlined below, and must be packaged individually.

Each major part is further divided into sub-parts. Some data parts apply to both the TGAI and the EP and should be submitted for each. Other parts apply specifically to the TGAI or the EP and should be submitted with either the TGAI or the EP application, as appropriate. Please refer to Appendix V for information on organizing and coding scientific data, studies, foreign reviews, comprehensive summaries, screening forms, and requests for waivers.

The DACO tables indicate the R and CR data for specific USCs. For CR data, the conditions under which the data would be required are provided in the DACO table. If the applicant realizes that a particular condition is applicable, it is essential that the CR data or a request for a waiver with a scientific rationale be supplied with the original submission. Where CR DACOs do not apply to a particular product, it is not necessary to reference these DACOs in the index or provide requests for waivers.

6.1 Data parts

Part 0, Index

The index must be submitted in both electronic format (PDF normal) and in hard copy with the appropriate number of copies (refer to Appendix V). The electronic version must be submitted on a diskette or CD. When submitting an index electronically, applicants must conform to the requirements outlined in Section 5.4. All submitted scientific data/studies, surrogate data/studies, requests for waivers and citations of previously submitted data that address a DACO must be properly indexed. Study protocols, comprehensive summaries, and requests for waivers accompanying or replacing studies along with the scientific rationale or surrogate data must also be indexed under the relevant DACO and added under a subtitle Comment in the fourth column on the sample Index template (Title, Source, Company.. etc) after Published or not (Appendix II) . When previously submitted data are used in support of a new submission, the data must be fully referenced in the index, as a Comment in the same location to indicate when the data were submitted, and the associated submission registration number. Separate indexes must be submitted for each proposed product: the TGAI and each EP. Please refer to Appendix II for directions on preparing electronic and hard copy indexes. If the data are organized using the DACO numbering system, the first column of the index labelled OECD data point number (as well as the title in the table) should be relabelled as PMRA Data Code.

If a single report covers more than one DACO, but not more than one part, a single entry in the index is acceptable. For example, if a single report addresses most of the chemistry requirements, or a request for waiver addresses an entire part, then there would be one index entry for the report, or waiver request, with the applicable DACOs indicated in the Comments field. Evaluation templates do not have to be cited individually.

Part 1, Label

All submissions involving changes to the label must include a label in both electronic format (PDF normal) and hard copy. Please refer to LPS2003-01 Labe1 Process Changes Part: Overview and LPS2003-02 Label Process Changes Part 2: Guidance for Industry for guidance on the requirements for submission of the label.

Labels that have been converted to a PDF normal format can be submitted electronically to the PMRA along with the appropriate application forms. These forms are also available electronically on the web.

The electronic version of the label should be saved in a PDF normal format and submitted on a 3.5" diskette or CD. When submitting a label electronically, the requirements outlined in Section 5.4 and in LPS2003-02 Label Process Changes Part 2: Guidance for Industry, must be followed.

More information on the labelling can be obtained from the Pest Control Products Regulations, the Registration Handbook, model labels (where available), and labels of registered products on the PMRA web site.

As outlined in the Regulations Amending the Pest Control Products Regulations, published in the Canada Gazette Part II on December 19, 2001, all registrations granted, amended or renewed must be based on bilingual label information (English and French) from January 1, 2003. The regulations prescribe a date of January 1, 2008 as the date by which all registered products must have bilingual labels, thereby allowing a five-year phase-in period. Please refer to LPS2003-01 Labe1 Process Changes Part: Overview and LPS2003-02 Label Process Changes Part 2: Guidance for Industry) for detailed guidance on the implementation of the bilingual labelling requirement as it impacts on the submission process.

Part 2, Product Chemistry: Technical Grade of Active Ingredient or Integrated System Product

Data must be organized according to the DACOs outlined in Appendix IV (DACO Part 2). Please refer to Regulatory Directive, DIR98-04 Chemistry Requirements for the Registration of a Technical Grade of Active Ingredient or an Integrated System Product, for more detailed information on chemistry requirements for a TGAI or an ISP.

Part 3, Product Chemistry: End-use Product or Manufacturing Concentrate

Data must be organized according to the DACOs outlined in Appendix IV (DACO Part 3). Please refer to Regulatory Directive DIR98-03, Chemistry Requirements for the Registration of a Manufacturing Concentrate or an End-Use Product Formulated from Registered Technical Grade of Active Ingredients or Integrated System Products for more detailed information on chemistry requirements for an EP or a MA.

Part 4, Toxicology: TGAI or EP

Data for the TGAI and the EP must be organized according to the DACOs outlined in Appendix IV (DACO Part 4). Refer to Memorandum T-1-245, Guidelines for Developing a Pesticide Toxicology Data Base, for information on toxicological studies. To help expedite the review of submissions, historical data for blood chemistry, hematology, tumour incidences, skeletal variation and other malformations should be submitted, if available, for the appropriate studies.

Part 5, Exposure (Occupational and/or Bystander): EP

Data must be organized according to the DACOs outlined in Appendix IV (DACO Part 5) and submitted with the EP package. Refer to Appendix VI for details on the DACOs for this part.

Part 6, Metabolism or Toxicokinetics Studies: TGAI or EP

Data must be organized according to the DACOs outlined in Appendix IV (DACO Part 6) and submitted with either the TGAI or the EP, as appropriate.

Part 7, Food, Feed and Tobacco Residue Studies: EP

Data must be organized according to the DACOs outlined in Appendix IV (DACO Part 7) and submitted with the EP package. Refer to Regulatory Directive DIR98-02, Residue Chemistry Guidelines, for details.

Part 8, Environmental Chemistry and Fate: TGAI or EP

Data must be organized according to the DACOs outlined in Appendix IV (DACO Part 8). Refer to Memorandum T-1-255, Guidelines for Determining Environmental Chemistry and Fate of Pesticides, for information on environmental chemistry and fate studies.

Part 9, Environmental Toxicology: TGAI and EP

Data must be organized according to the DACOs outlined in Appendix IV (DACO Part 9). In general, studies conducted according to scientifically supportable protocols and using relevant, established guidelines such as the U.S. EPA or the OECD guidelines will be acceptable. Applicants may submit study protocols for review prior to conducting a study.

Part 10, Value: EP

Data must be organized according to the DACOs outlined in Appendix IV (DACO Part 10) and submitted with the EP package. The following guidelines may also be useful in preparing a value package:

  • DIR93-17 Assessment of the Economic Benefits of Pesticides
  • T-1-215 Efficacy Data for Antimicrobial Products
  • DIR93-07a Guidelines for Efficacy Assessment of Chemical Pesticides
  • DIR93-07b Guidelines for Efficacy Assessment of Herbicides and Plant Growth Regulators
  • DIR96-01 Guidelines for Efficacy Assessment of Fungicides, Bactericides and Nematicides

6.2 Comprehensive data summaries (DACO 12.7)

Applications for registration of a major new use or new TGAI with related EP(s), that is, Category A submissions, must include a CDS prepared according to the Tier II and III models in the OECD Guidelines and criteria for industry for the preparation and presentation of complete dossiers and of summary dossiers for plant protection products and their active substances in support of regulatory decisions in OECD countries. This document is available on the Internet at the Organisation for Economic Co-operation and Development web site http://www.oecd.org.

For information on the requirement for submission of a CDS, refer to Regulatory Directives DIR96-05 and DIR97-01, Comprehensive data summaries. Summaries will provide reviewers with a clear comprehensive summary of the characteristics, risks and values associated with the proposed product. The summary should be in such detail that it is apparent that the applicant has performed a thorough evaluation of each study and reported the full detail of this evaluation. For major new uses, the CDS should incorporate only those studies submitted in support of the application.

Comprehensive Data Summaries should be submitted in a separate binder under DACO 12.7. This binder should be labelled as outlined in Section 7.1. Part summaries, e.g., DACO 4.1 and 5.1, are not required if a CDS has been submitted.

One electronic copy of the CDS (refer to Section 5.4) must be submitted in addition to the required number of paper copies. The applicant must describe the contents and file structure of the electronic version through a "Read Me" file or other means.

6.3 Requests for waivers of data requirements

When required data or studies are not submitted, the applicant must submit a request for a waiver of the requirement. Requests for waivers must be recorded in the index and supported by surrogate data: studies performed with a product other than the one indicated in the application for TGAI, raw material or EP as indicated in the DACO table, or a scientific rationale (with references), in place of the data or studies. The Comments field which should be used to indicate the nature of the information: request for waiver, surrogate study, and so on. The request for waivers with supporting rationale or surrogate data must be placed in the data binders under the appropriate DACO. Refer to Appendix VII for details on requests for waivers.

6.4 Using the same study or information to support more than one DACO

When a study or information is used to address more than one DACO within a specific data part, the information need only be included under one DACO and referenced for the other DACO(s). However, when information is used to support a DACO requirement in more than one data part, the information in its entirety must be submitted for both data parts, that is, data cannot be referenced between different data parts. The exceptions are Parts 6 and 7, which are reviewed by the same section of the Health Evaluation Division.

Data submitted for one submission can be cited to address the data requirements for another submission provided that the data is appropriate for, and applies to, the second submission. These submission(s) must be submitted at the same time and hence follow the same timelines (refer to Section 5.8 on tailgate submissions).

6.5 Using literature to address data requirements

When literature such as a published journal article is used as supporting data, it must be fully referenced in the index. The Comments field should be used for the citation, which should state the name of the journal, volume number and page numbers. A copy of the article should be submitted and placed in the binder of the related data part binder. Any references noted in the article may be requested.

6.6 Multiple or additional studies or information and evaluation templates

When more than one study is submitted for a particular DACO, all studies should be submitted under that DACO and separated by divider pages with side tabs. Refer to Section 7.0 below for instructions on labelling side tabs for divider pages. Evaluation templates, protocols or other information, excluding foreign reviews, submitted for a particular DACO should be included under that DACO and separated with divider pages. Evaluation templates should be included under the DACO corresponding to the study and placed before the study. Evaluation templates should be separated from the study using a divider page with a side tab. The Comments field should be used to indicate the nature of the information. When a study submitted does not correspond to a specific DACO, it should be submitted under the appropriate other study DACO within the pertinent data part, for example, Part 5, Exposure, DACO 5.14, Other Studies/Data/Reports.

Foreign reviews should be coded under DACO 12.5 as outlined in Appendix IV and included at the end of the last binder for its related data part. For example, a foreign review of toxicology data would be coded as DACO 12.5.4, but would be included at the end of the last binder for Part 4, Toxicology.

6.7 Published literature search

A search of published literature on the active ingredient(s) may be requested by the PMRA. Legible photocopies of both the printout and relevant papers should be submitted to the PMRA. These published papers should be organized as set out in Appendix V: each report should be submitted under the appropriate DACO. The Comments field of the index should be used for the citation, which should state the name of the journal, volume number and page numbers. The index should be updated to include these submitted published studies.

7.0 Organization of submission package

The components of a submission should be organized as outlined below. Separate packages and envelopes should be submitted for each proposed product, that is, the TGAI or ISP, the MA (if applicable), and each EP, and each should include a covering letter, application form, product specification form, fee form, fee, supporting documentation, label, index, and relevant data. Certain submission components should be submitted in an envelope while data components should be compiled in binders and boxed, as outlined below.

Envelope

The following elements for each TGAI or ISP, the MA (if applicable) and each EP should be submitted in an envelope. All envelopes should be placed in Box 1 of the shipment:

  • Covering letter, forms as required, fee and supporting documentation;
  • Label in hard copy.
  • One copy of the Material Safety Data Sheet (MSDS) for the proposed product and each formulant. The applicant should ensure that the MSDS includes the CAS number.
  • Labelled 3.5" diskettes or CDs.

Binders

Data parts and other information submitted under DACOs, such as waiver requests, foreign reviews and evaluation templates, should be organized in three-ring binders (8.5×11", and varying widths as necessary to a maximum of 3").

Other data, i.e., Parts 2-10, should be placed in binders, with each data part in a separate binder. Where necessary, data parts may be organized into volumes and may consist of a number of volumes. Each binder should be clearly labelled on both the cover and spine as outlined below. Divider pages with labelled side tabs indicating the DACO number should be used to separate studies and DACOs. When more than one study is submitted for a particular DACO, the divider tab should also include a reference number that is used in the Table of Contents to indicate the location of a particular study in the binder: DACO 7.3.1-1, for example, to indicate that this is the first study submitted under DACO 7.3.1. This referencing method should only be used in the data binders and not in the index.

Individual studies or DACOs and attachments should be paginated logically, with consecutive page numbers beginning at page 1. All data and information submitted must be legible. There should be only one set of page numbers on the studies.

7.1 Labelling of binders

The following information should be on the cover and spine of each binder:

  • Name of the registrant
  • Product name
  • Common name of the TGAI(s)
  • Part number and title
  • Volume number (of total number of volumes) for that particular part
  • DACOs included in volume
  • Date of submission

Examples:

XYZ Chemicals
Inc.
EXCELL Flea Control for Dogs
Active Ingredient: Pyrethrin
Part 3, Product Chemistry: EP
Volume 1 of 2
DACOs 3.1-3.3
May 19, 1996
XYZ Chemicals
Inc.
>
EXCELL Flea Control for Dogs
Active Ingredient: Pyrethrin
Part 3, Product Chemistry: EP
Volume 2 of 2
DACOs 3.4-3.5
May 19, 1996

7.2 Table of contents

If a binder contains more than one DACO, a brief table of contents for each binder should be included at the beginning of each binder. The table of contents should include the DACO, which also serves as the tab number for locating the study or information within the binder, DACO title, and abbreviated study citation (author, year, title). Foreign reviews should be noted in the table of contents.

Example of a single entry:

4.3.5 Short-term Dermal Hartley, M. and Murray, W. (1994) S-1234 (Technical Grade) Twenty-one Day Dermal Study in Rabbit.

7.3 Required number of copies of data

Refer to Appendix V for guidance on the number of copies required for data parts and other information supporting submissions.

8.0 Data submission

A complete application package, including forms, fees, data and supporting information and documentation, should be submitted directly to:

Submission Coordination and Documentation Division
Pest Management Regulatory Agency
Health Canada
A.L. 6605E1
2720 Riverside Drive
Ottawa, ON K1A 0K9

With the centralization of Submission Screening in the Submission Coordination and Documentation Division (SCDD) and co-location of the Science Division, direct delivery of data is no longer acceptable to the Science Division. Envelopes with forms, fees, labels, and other information should be included in Box 1 of a shipment for both the TGAI and EP(s).

When sending data in boxes, the weight of individual boxes must not exceed 15 kg (30 lbs).

Note: All required submission components must be submitted together. It is unacceptable to submit only some components, with an indication that more are to follow.

9.0 Maximum residue limits solely for imported commodities

Applications to establish MRLs for imported foods under the Food and Drugs Act (FDA) are to be directed to the PMRA. Applications for import MRLs for TGAIs not previously assessed and not currently registered in Canada will be treated as Category A submissions. Applications for additional import MRLs for previously assessed TGAIs will be treated as Category B submissions. Applicants should contact the PMRA for DACO tables for Category A or B submissions for establishing import MRLs.

List of Abbreviations

CDS
comprehensive data summary
CPSF
Control Product Specification Form
CR
conditionally required
DACO
data code
EAD
Environmental Assessment Division
EP
end-use product
EPA
Environmental Protection Agency (United States)
ESAD
Efficacy and Sustainability Assessment Division
FDA
Food and Drugs Act
FREAS
Food Residues Exposure Assessment Section
HDWP
heavy duty wood preservation
HED
Health Evaluation Division
IGR
insect growth regulator
IMEP
Import for Manufacture and Export Program
ISP
integrated system product
LSS
Laboratory Services Sub-division
MA
manufacturing concentrate
MRID
master record identifier
MRL
maximum residue limit
MSDS
Material Safety Data Sheet
OEAS
Occupational Exposure Assessment Section
OECD
Organisation for Economic Co-operation and Development
OPP
Office of Pesticide Programs (EPA)
OPPTS
Office of Prevention, Pesticides and Toxic Substances (EPA)
OUI
own use import
PDF
portable document format
PGR
plant growth regulator
PMRA
Pest Management Regulatory Agency
R
required
SCDD
Submission Coordination and Documentation Division
TGAI
technical grade of active ingredient
TOX
Toxicology Evaluation Section
URMULE
user requested minor use label expansion
URMUR
user requested minor use registration
USC
use-site category
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