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Finding Out about the Regulatory Decisions Made for Products Derived through Biotechnology

The Canadian Food Inspection Agency (CFIA) strongly supports providing consumers with information to help them make better food choices. One of the ways the CFIA can do this is to have an open, transparent regulatory system. Such a system provides consumers with information about how assessments are done, and it gives them details on particular assessments.

How do Canadians find out about the decisions made by the CFIA?

The CFIA prepares "decision documents" whenever regulatory decisions are made about plants with novel traits, including those derived through biotechnology. They explain in detail what was reviewed to make the decision, and why certain conclusions were reached. They provide background information, describe the plant's novel traits, and discuss the results of the assessment and evaluation of the potential environmental and livestock feed use impacts. Decision documents are available to the public in hard copy and on the Internet, and can be viewed at: http://www.inspection.gc.ca/english/plaveg/pbo/dde.shtml.

As a member of the Organisation for Economic Co-operation and Development (OECD), Canada submits non-confidential information on the environmental release of plants with novel traits, including those derived through biotechnology, to the OECD's publicly available Biotrack database

Can the CFIA release all information it receives during the approval process?

Confidential business information, also referred to as “proprietary information,” is not included in the CFIA’s decision documents, nor is it included in the documents on the OECD database.

The Government of Canada holds many trade secrets and other types of confidential business information on behalf of third parties, such as companies or academic institutions that submit new products for safety assessments. In legal terms, this proprietary information belongs to the companies that generate it and it has traditionally been protected by intellectual property law. In Canada, intellectual property includes, in part, patents, trademarks, copyright, plant breeders' rights, and trade secrets.

Protecting confidential business information does not mean that the information is not required to do an assessment. It also does not mean that the information is exempt from rigorous assessment. Confidential business information is subjected to the same assessment standards as all other required information. Regulators will not continue to conduct a safety assessment, nor make a decision, unless submission of information is complete and fully addresses evaluation criteria. There is a wide range of expertise available within the CFIA to evaluate new products of agricultural biotechnology, including any confidential business information that is included in assessments. CFIA personnel include animal nutritionists, ecologists, entomologists, toxicologists, veterinarians, and molecular and plant biologists. This combination of expertise contributes to complete and rigorous reviews by the regulatory team.

Confidential business information is considered valuable to the companies that provide it for assessments, and the government is required by law to assure that such information is not given to unauthorized recipients. Innovators invest their resources into research and development, and to protect their investment, they obtain confidentiality protection from the government when submitting information required for approval of products. The information they provide is reviewed as part of the environmental assessment but is not made available publicly because such information could be used by the competitors of an institution or company which has received approval for a product, to the economic detriment of the people who invested in the work to produce the information.

The status of information submitted as confidential is subject to the federal Access to Information Act and the Privacy Act. Data and other scientific or technical information are reviewed and filed in strict confidence. Section 20 of the Act protects third party commercial, scientific or technical information and is a mandatory exemption, which means that government institutions must not disclose certain confidential business information. This is true whether the circumstance is the provision of information for the public, such as a regulatory decision document, or when product assessment information is subject to an access to information request by a third party.

Section 20 of the Access to Information Act gives the government the authority to refuse to disclose third party information that could cause injury to the interest of the institute or company. Section 20 reads as follows:

Third party information

20. (1) Subject to this section, the head of a government institution shall refuse to disclose any record requested under this Act that contains

• trade secrets of a third party;
• financial, commercial, scientific or technical information that is confidential information supplied to a government institution by a third party and is treated consistently in a confidential manner by the third party;
• information the disclosure of which could reasonably be expected to result in material financial loss or gain to, or could reasonably be expected to prejudice the competitive position of, a third party; or
• information the disclosure of which could reasonably be expected to interfere with contractual or other negotiations of a third party.