Confidential Business Information (CBI)

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Bruce Robertson
Project Manager, Confidential Business Information and Privacy Unit
Submission & Information Management Division
Registration Directorate

Confidential Business Information and Transparency

• The new PCPA requires the PMRA to be more transparent:
  • Provides for the public to view confidential test data (CTD) after a regulatory decision is made
  • but confidential business information (CBI) must not be released to the public.

PCPA Definitions

CTD

Any scientific or technical information which may be refused under the Access to Information Act and relates to the health or environmental risks or the value of a pest control product.

CBI

Information that is designated as CBI by the applicant/registrant and concerns:

• Manufacturing or quality control processes
• Methods for determining the composition.
• Monetary value of sales and other financial and commercial information.
• Identity and concentration of formulants and contaminants other than those considered to be of health or environmental concern.

PCPA Reference to Requirements

• CBI must be designated by the information provider - see PCPA 43 (4)
• The PMRA has the authority to determine the form and manner in which information is provided - see PCPA 7 (1)
• The PMRA decides whether designated information meets the definition of CBI - see 43 (6)
• The PMRA must give written notice to the information provider if it is determined that designated information is not CBI and the reasons for it - 43 (7)

Confidential Business Information = CBI

Methodology for Newly Submitted Test Data

1. Directive 2006-03: CBI Designation and Segregation Part 1: Submitted Test Data
   • CTD must be submitted via e-index with CBI designations provided up front in the index.
     • If the whole document meets the definition of CBI it can be claimed as such.
     • Or where the study only contains partial CBI, applicant must have extracted CBI from each document and placed it in a companion CBI reference document for each applicable study.

Example - Appendix III - CBI Designation Methodology Document -DACO 0.8.11

Check one of the following:

1. "CBI designation has been completed using only the XML e-Index CBI field. No verification of any Statement of CBI page is required by the PMRA."
   OR
2. "CBI designation has been completed by inserting a signed Statement of CBI page in each document submitted and by using the XML e-Index CBI field."

Signature
If the document is electronic, the signature must be incorporated and displayed in the PDF file, including, but not limited to, graphic representations of cursive signatures, typed free text and digital signatures.

Name, title
Company
Date dd-mm-yyyy

Optional Statement of CBI Page

• "No claim of CBI is made for any information contained in this document on the basis of the definition of CBI under the PCPA 2002."
• "The entire document is claimed as CBI on the basis of the definition of CBI under the PCPA 2002."
• "Information claimed as CBI, as per the definition of CBI under the PCPA 2002, has been removed to a CBI Reference document."

Segregation of CBI for New Test Data

• Where a document contains some CBI:
  • Extract CBI from parent document, and replace with a reference code.
  • Place the excised CBI in a CBI reference document.
  • Use copy row function in e-index builder to create CBI reference document (all info will be the same as parent except for CBI field).

Appendix II: Example - CBI Reference Document

Confidential Business Information Reference

Parent document Lab Report Number: 3.141592654
DACO: 4.3.1
Author(s): John Doe, Jane Doe and Bob Doe
Title: Short-term Oral Toxicity Study in Rats
Report date: 1999

25 April 2006

CBI Reference Document page 2

CBI reference code: 11111
Page Number and line: 60 (line 20)
CBI: Formulant: propylene glycol
Reason for deletion: Formulant name

CBI reference code: 11112
Page Number and line: 71 (line 15)
CBI: Formulant: propylene glycol
Reason for deletion: Formulant name

Methodology for Test Data Previously Submitted

• DIR2006-04: CBI Designation and Segregation Part 2: Previously Submitted Data
  • PMRA automatically designates all chemistry data (DACOs Part 2 and 3) as CBI, and for all additional CBI claims on data:
    • PMRA sends to registrant an e-index of all other CTD (no document attached.
    • Applicant returns e-index and: Confirms the company is authorized to designate CBI by returning the e-index with CBI designations (in e-index), and CBI reference documents attached (if applicable)
    • PMRA verifies CBI claims and extracts CBI from the document as directed by the returned companion CBI reference document(s) with acceptable reason for the claim.
    • No response = No additional claim of CBI: i.e. document can be released to R. Room as is

CBI Designations in Previously Submitted Test Data

• CBI Field Options:
  • No Authority
  • Yes
  • No
  • Partial
  • Request Copy

Process Challenges

• Timeliness of applicant response to CBI letters.
• Over-designation of CBI.
• Do not modify e-index content other than the CBI designation field.
• Sending new documents to PMRA in response to a CBI letter.
• Not including the 0.8.11 CBI Methodology Document for newly submitted test data.
• References:
  • DIR2006-03: CBI Designation and Segregation, Part 1: Submission of Test Data.
  • DIR2006-04: CBI Designation and Segregation, Part 2: Previously Submitted Test Data.