Balancing Industry Confidentiality with the Public Right of Access

Balancing Industry Confidentiality with the Public Right of Access

Kathryn Garforth, Centre for International Sustainable

Development Law

Introduction

Access to information is a principle of international sustainable development law:

‘The Principle of Public Participation and Access to Information and Justice’

International Law Association, Principle 5 of the New Delhi Declaration of Principles of International Law Relating to Sustainable Development (2002)

Introduction

• Human rights instruments:• International Covenant on Civil & Political Rights• International Covenant on Economic, Social & Cultural

Rights

• Environmental instruments:• Convention on Biological Diversity• Framework Convention on Climate Change

• Economic instruments:• Use of amicus curiae briefs in disputes at WTO and NAFTA

• Integrative instruments:• Rio Declaration• Cartagena Protocol on Biosafety

Introduction

Conflict between access to information and confidentiality in the context of biotechnology

• Confidentiality for competitive purposes• Confidentiality for IP purposes• Access by individuals to ensure that

they & their environment being protected

• Regulation of the product not the process All plants with novel traits subject to same regulations regardless of whether novel traits introduced by modern biotechnological or more traditional cross-breeding techniques.

• Substantial equivalenceNew crop varieties may be considered substantially equivalent to pre-existing varieties already determined to be safe. Only ‘plants with novel traits’ must go through full risk assessment process.

‘Plants with Novel Traits’

• Seeds Act, Seeds Regulations & regulatory directives set environmental risk assessment data requirements

• Administered by CFIA

• However: applicant may omit information on environmental risks “if the Minister determines, on the basis of a written scientific rationale provided by [the applicant], that the information or part is not relevant or cannot practicably be obtained and is not required for the Minister’s decision” (r. 110(4)).


• Applicants can classify portions of applications as ‘confidential business information’.

• CFIA releases short Decision Documents that contain summaries of information submitted by applicant but does not release actual data.


Section 2 creates a presumption of access:

The purpose of this Act is …to provide a right of access to information in records under the control of a government institution in accordance with the principles that government information should be available to the public, that necessary exceptions to the right of access should be limited and specific and that decisions on the disclosure of government information should be reviewed independently of government.

Canadian Access to Information Act

Section 20 - Third Party Information

s. 20(1): mandatory exemptions from disclosure

• Class-based exemptions: trade secrets & information supplied in confidence

• Harm-based exemptions: information that could harm competitive position of 3rd party & information that could interfere with negotiations of 3rd party



s. 20(2): mandatory exception to the exemptions• Access will be granted where record contains

results of product or environmental testing done by or on behalf of government institution unless testing was done as service to person, group or organization other than government institution and for a fee.

• Does not include testing done by companies as part of applications for release of PNTs.



s. 20(6): discretionary exception to the exemptions (except trade secrets)

• Record may be disclosed if disclosure would be in public interest as it relates to public health, public safety or protection of environment & if public interest in disclosure clearly outweighs any financial loss or gain to, prejudice to competitive position of or interference with contractual or other negotiations of third party.

• Little used.


The functioning of access to information

How are access & confidentiality being balanced in practice?

Access to Environmental Information in Applications for Unconfined Release of

PNTs

Expert Panel of Royal Society of Canada, Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada (2001)

• Applicant gets to decide what counts as CBI. Regulator could negotiate for greater disclosure

• Recommendation:– Data and rationales upon which risk assessments and

regulatory decisions are based should be available to public review.


PNTs

Government Action Plan & Progress Reports in response to Royal Society report

• CFIA does not commit itself to making data available to public review


PNTs

Canadian Biotechnology Advisory Committee, Improving the Regulation of Genetically Modified Foods and Other Novel Foods in Canada (2002)

• Recommendations reinforce those of Royal Society

• Detailed scientific & technical data pertinent to human health and environmental safety assessments should be made public, except for details that could unduly jeopardize a company’s competitive position.


PNTs

Doctoral students filed for access to environmental risk assessment information submitted by Monsanto and AgrEvo.

• Received Monsanto data based on agreement from company• AgrEvo refused to grant access:

“AgrEvo representative responsible for this decision stated that all information submitted to the federal government by private companies regarding a product is considered CBI. If the government determines that no health hazard is related to the product, it is the decision of the company whether or not to release information to the public.”

Fundamental misinterpretation of both allowances for CBI and functioning of Access to Information Act.


PNTs

Courts have elaborated tests for determining whether information falls into one of s. 20(1) exemptions.

• Determinations must be made objectively• Exempting information from disclosure not simply based on

assertions of those seeking to prevent disclosure• 3rd party has burden of showing why information should not be

disclosed.• No de facto rule that all information submitted to government by

private companies is considered CBI

Head of government institution has decision-making authority regarding granting or denying access to information. Not proponent’s decision


PNTs

If CFIA is leaving proponents to decide for themselves when information can be released under an access request and when it will be kept confidential then the Agency has abdicated its responsibility in applying the rules of the Access to Information Act.

Act itself may balance confidentiality with access but this balance not being applied in practice.


PNTs

Access to information & protection of the environment


PNTs

Those who have gained access found problems:

• Barrett, Canadian Agricultural Biotechnology: Risk Assessment and the Precautionary Principle (Ph.D. thesis, 1999)- “significant shortcomings in the depth and

breadth of questions, methods of inquiry, analysis of data, and plausibility of conclusions”

• Auditor General (2004): - CFIA’s files incomplete and poorly organized,

unclear and little-used data standards.


PNTs

Environment at risk?• Problems with ‘stacking’ of herbicide

tolerant genes

• Value of public in monitoring regulators & regulated.

• Need for access to information to fulfill this role.


PNTs

1. Proper application of existing access to information rules

– Better understanding of tests for when information falls into s. 20(1) exemptions and how to apply these tests

– Applying exemptions in fewer instances by making environmental risk assessment information public as is done in Australia and New Zealand, and in Canadian regulation of pesticides.

What is Needed?

2. Development of new obligations

– Greenpeace: creation of a right of access to studies that are basis for government decision-making on GMOs, as exists in Europe.

– Ratifying Cartagena Protocol on Biosafety and implementing its Article 23.

What is Needed?

3. Recognition of access to information as key component of sustainable development

Without access to information:

• individuals cannot fulfill their role as citizens in a democratic society

• Biotechnology will not contribute to sustainable development in Canada - as promised in Canadian Biotechnology Strategy - and its role must be reconsidered.

What is Needed?