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Notices of Submission
Biotechnology Notices of Submission Project
Background | Frequently Asked Questions
Current and Archived
Submissions | Submission Example | Submission Template
Government evaluators from the Canadian Food Inspection Agency (CFIA) and Health Canada
assess new agricultural products of biotechnology for food, livestock
feed, and environmental safety. Product developers are required to follow
regulatory directives and guidelines by supplying evaluators with detailed and
comprehensive information about their products.
The CFIA and
Health Canada are launching a pilot project to post on the CFIA Web site "notices of
submission" that describe the product and the data they receive from
certain product developers who have requested safety assessments of plants with novel traits (PNTs) for unconfined release and
safety assessments of novel
feeds and novel foods derived from PNTs.
Currently, the CFIA and Health Canada post
decision documents on the Internet after a product has been approved. They have
not previously posted information about products that are under review, as will
be the case in this pilot project.
CropLife Canada is an industry association that represents
approximately 85 % of industry plant biotechnology developers in Canada.
Developers of PNTs and
novel feeds and novel foods derived from PNTs, who are also members of CropLife
Canada, have volunteered to write these notices of submission to accompany
their submissions to the CFIA and Health Canada.
Why are we doing this?
The reasons we are doing this are:
We invite readers to give their comments on the content of the notices of
submissions received from CropLife members.
| Q. |
What happens to the comments the CFIA and HC receive via email or post? |
| A. |
Scientific questions or information will be
forwarded to CFIA and Health Canada
evaluators for consideration in the assessment. Non-scientific
input will be evaluated and appropriate ways of addressing it will be
explored. Subject to your consent, the CFIA will forward your comments to
developers whose products are being assessed and may post them on the CFIA and
Health Canada Web sites (please indicate this consent if sending comments by
postal mail). Developers will not be given your name or e-mail and postal
address, nor will any personal information be posted on the CFIA or Health
Canada Web site.
|
| Q. |
What happens to my personal information when I
send in a comment? |
| A. |
All personal information shall be treated in accordance with the
Privacy
Act and the Access to Information Act.
|
| Q. |
Will notices now be posted on the CFIA and Health Canada Web sites,
for all submissions for PNTs and novel feeds and novel foods
derived from PNTs? |
| A. |
No. This pilot project involves only members of the industry
association
CropLife Canada, which represents approximately 85 % of
industry plant biotechnology developers in Canada. These companies
have volunteered to write and submit the notices of submission to demonstrate
their support and understanding of the public desire for more transparency in
the regulatory system.
|
| Q. |
Why don't the CFIA and Health Canada make all
companies post these notices of submission? |
| A. |
There is no requirement for this in the acts and regulations
administered by the CFIA and Health Canada.
|
| Q. |
Will notices of submission from all applicants (not just
CropLife members) be posted on the Internet? |
| A. |
The CFIA and Health Canada recognize
the need to increase the disclosure of information and are currently exploring
ways to encourage all developers to participate in the notices of submission
project.
|
| Q. |
How can I get more information about a product
that has been posted as part of this project? |
| A. |
Please contact the developer that submitted the product (contact
information is available at the end of each notice of submission).
|
| Q. |
How can I find out about other notices of
submission that aren't part of this project? |
| A. |
For applicants not currently participating in this project,
information that is not considered to be confidential business information
remains available from the applicant or through the access to information process.
|
| Q. |
Who decides what is "confidential business
information" (CBI)? |
| A. |
The federal Access to Information Act sets out what can and
cannot be considered CBI. More information on CBI is available in the
CFIA factsheet
"Finding Out about the
Regulatory Decisions Made for Products Derived through Biotechnology".
|
| Q. |
How will I know when a decision has been
made? |
| A. |
Decision documents are made available on the CFIA and Health Canada Web sites for PNTs that are authorized for environmental
release, and novel feed and novel food use. These documents describe how
regulatory authorities determined the safety of these crops and why certain
conclusions were reached. People who sent comments or information via the
Internet will be sent a Web site link to the decision document. People who gave
input through regular post will have a decision document mailed to them.
|
| Q. |
How will the CFIA and Health Canada
measure the success of this project, and who decides if it
continues? |
| A. |
The CFIA and Health Canada will use
this pilot project to gauge the public's interest in this information, and
to see how accessible the information is in this format. We will do this based
on the number and type of responses we receive, as well as through a user
survey.
|
Disclaimer:
The CFIA and Health Canada, including
their employees, are not responsible for the content of any Notice of
Submission posted herein. All Notices of Submission are the responsibility of
the Applicant submitting them. The CFIA and Health Canada, including
their employees, do not make any warranty, express or implied, or assume any
legal liability or responsibility for the accuracy, completeness or usefulness
of any information, product or process disclosed by or in any Notice of
Submission posted herein. The CFIA and Health Canada, including
their employees, do not represent that the use of any information, product or
process disclosed by or in any Notice of Submission posted herein would not
infringe privately owned rights. All and any reliance on or use of any
information, product or process disclosed by or in any Notice of Submission is
at the sole risk of the person(s) so using it or relying thereon.
The CFIA, including its employees, is
not responsible for the content of any Notice of Submission posted herein. All
Notices of Submission are the responsibility of the Developer submitting them.
The CFIA, including
its employees, does not make any warranty, express or implied, or assumes any
legal liability or responsibility for the accuracy, completeness or usefulness
of any information, product or process disclosed by or in any Notice of
Submission posted herein. The CFIA, including its employees, does
not represent that the use of any information, product or process disclosed by
or in any Notice of Submission posted herein would not infringe privately owned
rights. All and any reliance on or use of any information, product or process
disclosed by or in any Notice of Submission is at the sole risk of the
person(s) so using it or relying thereon.
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