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Regulatory Directive: Guidelines for the Registration of Microbial Pest Control Agents and Products

Appendix I Data Code (DACO) for Microbial Pest Control Products

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Appendix II Elements of a Complete Submission to Register, to Amend or to Conduct Research With a Pest Control Product

Some of the elements listed below are conditionally required depending on the purpose of the submission. For more information, refer to the Registration Handbook for Pest Control Products Under the Pest Control Products Act and Regulations.

Required Elements include:

1. Covering letter: outlining the purpose of the submission and a brief description of the submitted package. It should include the product name, a brief description of the intended use of the product, a reference to related submissions, and relevant history, if applicable. Data should not be included as part of the covering letter. A distinct letter should be included with each submission.
   
   The covering letter must be submitted with the envelope (refer to Section 4.2). A copy of the covering letter must be included in the Summary Binder. Copies of the covering letter should not be included in other data binders.
   
   
2. Application form: completed, signed and dated.
   
   
3. Fee: as indicated on the application form in a cheque payable to the Receiver General for Canada.

Conditionally Required Elements include:

1. Product specification form: completed, signed and dated.
   
   
2. Letter(s) of confirmation: of source of active ingredient(s).
   
   
3. Letter(s) of authorization: to cite data previously submitted by another company.
   
   
4. Letter(s) of authorization: designating agent, formulator, consultant, etc.
   
   
5. Letter(s) of authorization: to share data reviews with other countries.
   
   
6. Draft label: in the proper electronic and paper formats. See Section 5, Part 1.1 and Appendix IV.
   
   
7. Index: of supporting data in the proper electronic and paper format. See Appendix III.
   
   
8. Scientific data or studies: supporting the safety and effectiveness of the proposed product or amendment.
   
   
9. Foreign reviews: of the submitted scientific data or studies, if available.
   
   
10. Comprehensive data summary: in accordance with the EC guidelines. Refer to Regulatory Directives DIR96-05 and DIR97-01, Comprehensive Data Summaries.
    
    
11. Requests for waivers: from the requirement of producing and submitting specific scientific data/studies. Such requests must be recorded in the index and supported by surrogate data or a scientific rationale in place of the DACO or study.

Appendix III Directions for Creating a Data Index

Electronic Format

All data and supporting information submitted, including requests for waivers, surrogate studies, foreign reviews, protocols, study screens, and literature, should be listed in the index in the format outlined below. Field titles should not be included in the index. Refer to the examples that follow.

Field - Information

• DACO Number - corresponding Canadian DACO number (Please refer to Appendix I)
• Author(s) - surname, initial(s)
• Date (Year) - year report written by laboratory (not year submitted)
• Title - full title as it appears in the report
• Testing Lab Name - where different from company name
• Testing Lab Report No. - Lab Report Number assigned by the testing laboratory
• Full Date - give date of report as day, month, year, where date is written out in full
• Company Name - of data submitter/data owner
• Company Report No. - Company Report Number assigned by the Company
• Volume No. of Data Part - volume number for the particular data part
• No. of Pages - total number of pages of the study
• City - of data submitter/data owner
• Country - of data submitter/data owner
• Published/Unpublished - state whether the material is published or unpublished
• Date of Submission - day, month, year
• EPA MRID No. - if available
• Comments - Comments of the Company, e.g., foreign review, crossreferencing

Applicants should submit a 3.5" diskette, with the index information saved in a valid WordPerfect or ASCII delimited text format. When applicants wish to author the index in a different electronic environment, it is the applicant's responsibility to confirm that no text loss or format changes have occurred as a result of the conversion. Format should be a hard return for each line with a double hard return between each study. Repeated as many times as there are studies.

The diskette should be labelled with the following information:

• name of the registrant
• product name
• scientific name and strain designation of the MPCA
• part number and title
• date of submission
• diskette format, i.e., WordPerfect or ASCII

Default Entries

Where standard citation information is not available or is unclear, a default entry of N/S acceptable. Exceptions include:

• Where authors are not identified, use Anonymous.
• When the report number is known but not the authors, it may be possible to reference the name of the study director.

Viruses

Note: Applicants are required to provide diskettes that are certified virus-free. Any diskette found to contain a virus will be returned to the applicant.

Examples of Index Entries

4.3.5
Hartley, M. and Murray, W.
(1994)
S-1234 (Technical Grade) twenty-one day dermal study in rabbit
Happy Labs., United Kingdom
Report Number 007
Report Date 25 January 1994
Pesticide Company 1
N/S
N/S
58 Pages
Bilthoven
Netherlands
Unpublished
26 March, 1994
N/S
N/S

4.6.4
Anonymous
(1985)
Eye Sensitivity Studies with 20% EC
Huntington Research Centre
Report No. FMT6-85539
Report Date January 16 1985
Pesticide Company 2
Company Report No. 5
Volume 23
88 Pages
N/S
England
Unpublished
April 12, 1994
N/S
N/S

Hard Copy (paper) Format

An abbreviated index may be submitted as the hard copy version provided it contains the following information:

DACO
Author
Date (year)
Title (underlined)
Location of study (i.e., part number, volume number, tab number in the volume)
Total number of pages of the study or DACO
Submission Date
Comments

Example:

4.3.5 Hartley, M. and Murray, W. (1994) S-1234 (Technical Grade) twenty one day dermal study in rabbit, Part 4, Vol. 1, tab 4.3.5. (58 pages). March 21, 1997.

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Appendix IV Directions for Creating a Draft Label

Basic label requirements are outlined below. For more detailed information on the preparation of product labels, refer to the Registration Handbook for Pest Control Products Under the Pest Control Products Act and Regulations (Registration Handbook).

Principal Display Panel

1. Product Name

• Must match name on the application form
• Should be specific to the product and be descriptive of its physical form and purpose
• Should not be misleading or contain unacceptable or scientifically unsupportable adjectives, e.g., Natural, Organic, etc.

2. Class Designation

• Based on intended use and potential hazards
• Must match class indicated on application form
• Usually only one class designation accepted per product (there are some exceptions with combined commercial and manufacturing, commercial and restricted, etc.)
• Class designation must be one of the following:
  • Domestic
  • Commercial (Agricultural, Industrial or Institutional)
  • Restricted
  • Manufacturing

3. Precautionary Symbols and Words (refer to criteria in the Registration Handbook)

• This information is not usually necessary for microbial products; however, if required according to the criteria presented in the Registration Handbook, Poison, Flammability, Explosive, and Corrosive hazard symbols and signal words must appear on the label.

4. Read the label before using Statement

• If the product labelling includes a brochure or pamphlet, this should be indicated on the label, i.e., Read the label and brochure before using.

5. Guarantee Statement

• The guarantee on the label must match that on the product specification form and both of these are to reflect the concentration of the active ingredient(s) as described in Part 2.9.2 of these guidelines.

6. Registration Number

• The registration number on the label must match the one assigned.
• This number must appear as: Registration Number XXXXX Pest Control Products Act, or if it is a domestic class product and size is a limiting factor, as Reg. No. XXXXX P.C.P. ACT.

7. Net Contents

• Must be expressed in metric units (imperial measure may appear in brackets after the metric measure)
• Liquids are expressed in millilitres (mL) or litres (L) and solids or pressurized products are expressed in grams (g) or kilograms (kg).

8. Name and Full Postal Address of Registrant

• Must match that in box 6 of the application form
• The name and address of the Canadian agent is required on the label if the registrant resides outside of Canada.
• The registrant's telephone number is required on the label of technical or manufacturing products.
  
  Note: For domestic class products of very small size, points 5, 6, 7 and 8, listed above, can appear on the secondary display panel.

Secondary Display Panel

1. Directions for use

• Must include complete information on application rates, how to apply the product, and use limitations.
• For technical or manufacturing products, the standard Directions for use statement is: To be used only in the manufacture of a pesticide which is registered under the Pest Control Products Act. Read Technical Bulletin for formulation details. (Please note that the word pesticide can be replaced with biological insecticide, herbicide, fungicide, etc.)

2. Precautions

• Must include information on any significant hazard relating to handling, storage, display, or distribution of the product, and how to alleviate such hazards
• Must include any significant hazard relating to human health, wildlife, or the environment that may result from the use of the product, along with instructions on how to alleviate such hazards
• Should include the statement: Keep out of reach of children

3 and 4. First Aid and Toxicological Information

• This information is not normally necessary for labels of microbial products, but a clear and concise statement of practical first aid measures will be required in cases where the product could pose a hazard as the result of accidental contact with skin or eyes, or ingestion or inhalation.

5. Storage Statement

• Must include information on appropriate storage conditions (e.g., temperature range and light restrictions) and any other relevant information aimed at ensuring product stability, performance and safety.

6. Disposal

1. For products of Domestic class designation:
   
   Do not reuse empty container. Dispose of empty container with household garbage.
   
   
2. For products of Commercial class designation:
   
   
   • Liquid:
     
     
     1. Rinse the emptied container thoroughly and add the rinsing to the spray mixture in the tank.
     2. Follow provincial instructions for any required additional cleaning of the container prior to its disposal.
     3. Make the empty container unsuitable for further use.
     4. Dispose of the container in accordance with provincial requirements.
     5. For information on the disposal of unused, unwanted product and the cleanup of spills, contact the provincial regulatory agency or the manufacturer.
        
        
   • Solid:
     
     
     1. Thoroughly empty the contents of the container into the application device.
     2. Make the empty container unsuitable for further use.
     3. Dispose of the container in accordance with provincial requirements.
     4. For information on the disposal of unused, unwanted product and the cleanup of spills, contact the provincial regulatory agency or the manufacturer.
        
        
3. For products of technical or manufacturing class designation:
   
   Canadian formulators of this technical should dispose of unwanted active and containers in accordance with municipal or provincial regulations. For additional details and the cleanup of spills, contact the provincial regulatory agency or the manufacturer.

7. Notice to User

• The Notice to User statement, below, is required on all Commercial, Restricted and Manufacturing class products:
  
  This control product is to be used only in accordance with the directions on this label. It is an offense under the Pest Control Products Act to use a control product under unsafe conditions.

8. Notice to Buyer (optional)

• If a registrant wishes to include a notice to buyer statement on the label, the wording must be as follows:
  
  Seller's guarantee shall be limited to the terms set out on the label and, subject thereto, the buyer assumes the risk to persons or property arising from the use or handling of this product and accepts the product on that condition.

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Sample Draft Label

Principal Panel

LEP BE-GONE
Flowable Biological Insecticide

Restricted For use in Forestry

Read the label before using
Keep out of reach of children

Guarantee: Bacillus thuringiensis var. kurstaki, strain RL 99: 10,000 International Units of potency per mg (equivalent to 12 billion International Units of potency per litre)

Registration No: XXXXX Pest Control Products Act

Precautionary symbols and signal words (if appropriate)

Net Contents: 1 L

XYZ Biologicals Inc.
Postal Address
City Province Postal Code

Lot Number (if required)
Expiry Date (if required)

Secondary Panel

Precautions: Keep out of reach of children. Avoid contact with skin, eyes and clothing. Wash with soap and water after use.

First Aid: In case of contact, flush skin or eyes with clean water. If irritation persists, obtain medical attention or contact a poison control centre.

Storage: Store at temperatures between 0°C and 15°C. Store container upright and keep tightly closed when not in use. After extended storage, vigorously shake or stir contents to assure a uniform suspension.

Disposal: Do not reuse container. Follow provincial instructions for any required cleaning of the container prior to its disposal. Make empty container unsuitable for use and dispose in accordance with provincial requirements. For information on the disposal of unused, unwanted product and the cleanup of spills, contact the provincial regulatory agency or the manufacturer.

Appendix V Required numbers of copies of information supporting submissions for microbial pest control products

1 One electronic copy as well as hard (paper) copies in the format prescribed in this document are required.
2 Two additional paper copies of the label are required and should be submitted in the envelope with the cover letter, i.e., not in binders but with the non-data submission components.
3 These items are to be combined in the summary binder.

Acronyms
EAD: Environmental Assessment Division
HED: Health Evaluation Division
PSCD: Product Sustainability and Coordination Division
SMID: Submission Management and Information Division

Appendix VI Human Health and Safety Testing Requirements

Appendix VII Microbial Pesticide Ecozones of Canada

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Appendix VIII Environmental Toxicology and Environmental Fate Testing Tiers

Appendix IX Environmental Toxicology and Fate Testing Requirements

* For greenhouse uses, the need for environmental testing will depend largely on the type (i.e., the design and operation of greenhouse facilities in which the EP will be applied) and the degree of environmental exposure (i.e., the level of containment) anticipated under operational conditions of use. Advance consultation with the PMRA is recommended to identify specific data requirements for the MPCA in question.

Appendix X Non-target Toxicology Testing

* Tier III testing is not required for indigenous MPCAs

Appendix XI Suggested Taxa for Selection of Non-target Arthropods

Appendix XII Suggested Taxa for Selection of Non-target Plant Species

Appendix XIII List of Relevant Publications

Regulatory Authority

Pest Control Products Act and Regulations

Food and Drugs Act and Regulations

PMRA Companion Guidance Documents

Registration Handbook for Pest Control Products Under the Pest Control Products Act and Regulations (Registration Handbook)

Regulatory Proposal PRO93-05, Research Permit Guidelines for Microbial Pest Control Products

Regulatory Directive DIR93-07a, Guidelines for Efficacy Assessment of Chemical Pesticides

Regulatory Directive DIR93-07b, Guidelines for Efficacy Assessment of Herbicides and Plant Growth Regulators

Regulatory Directive DIR93-17, Assessment of the Economic Benefits of Pesticides

Regulatory Directive DIR96-01, Guidelines for Efficacy Assessment of Fungicides, Bactericides and Nematacides

Regulatory Proposal PRO96-01, Management of Submissions Policy

Regulatory Directive DIR98-01, Good Laboratory Practice

Regulatory Directives DIR96-05 and DIR97-01, Comprehensive Data Summaries

Instructions for Organizing and Formatting a Complete Submission Package for Pest Control Products (pending publication)

Other publications of interest

International Commission on Microbiological Specifications for Foods (ICMSF). 1978. Microorganisms in Foods, 1. Their Significance and Methods of Enumeration. 2nd Edition. International Commission on Microbiological Specifications for Foods. University of Toronto Press, Toronto (ISBN 0-8020-2293-6).

International Commission on Microbiological Specifications for Foods (ICMSF). 1986. Microorganisms in Foods, 2. Sampling for Microbiological Analysis. Principles and Specific Applications, 2nd Edition. International Commission on Microbiological Specifications for Foods. University of Toronto Press, Toronto (ISBN 0-8020-5693-8).

Laboratory Biosafety Guidelines (2nd Edition, 1996, Health Canada, Ottawa, Ontario, ISBN: 0-662-24214-9)

OECD Guidelines for Testing of Chemicals # A-404, Acute Dermal Irritation, 1993