Economic Study of Costs Associated with Amendments to the New Substances Notification Regulations (Organisms)

1.0 Mandatory Requirements

The following Mandatory Requirements must be met in order to have your proposal considered:

M1. The Bidder must hold a valid Designated Organization Screening (DOS), with approved document safeguarding at the level of PROTECTED B issued by the Canadian Industrial Security Directorate (CISD), Public Works and Government Services Canada (PWGSC) at the time of response to this request for proposal. In order to demonstrate this requirement, the bidder must provide a copy of the confirmation letter from CISD for the DOS with Document Safeguarding – PROTECTED B registration.

M2. Each resource proposed by the bidder must hold a security accreditation to the level of Reliability at the time of response to this request for proposal. In order to demonstrate this requirement, each resource must be listed, along with their clearance level and the security clearance number or a confirmation letter from the issuing department.

M3. The Bidder shall have a minimum of three years professional work experience in conducting economic studies;

M4. The bidder must provide three references for whom the bidder has carried out an economic study related to incremental administrative and compliance costs, including costs associated with meeting regulatory requirements which has been delivered within the last 3 years.  Information to be provided includes the name of the company or organization(s); contact names, telephone numbers and e-mail addresses. 

M5. The Bidder must have successfully carried out two similar projects within the past 5 years.  To be considered similar, the projects must have been economic impact analysis studies within the science sector.  

M6.   At least one member of the team proposed by the Bidder shall have a university science or engineering degree in Biology, Veterinary Science, or Molecular Biology. Proof of degree must be provided upon request;

M7. At least one  member of the team proposed by the Bidder shall have, as a minimum, a Master’s degree in economics or related discipline. Proof of degree must be provided upon request;

M8. At least one member of the team proposed by the Bidder shall be capable of communicating in both official languages (English and French);



1.1 Intellectual Property

Environment Canada has determined that any intellectual property arising from the performance of the work under this Contract will be vested in Canada on the grounds that the main purpose of the Contract, or of the deliverables contracted for, is to generate knowledge and information for public dissemination (section 6.4.1 of the Treasury Board of Canada Secretariat Policy on Title to Intellectual Property Arising under Crown Procurement Contracts).
2.0 OBJECTIVE

The objective of this study will be to estimate the incremental costs of the proposed amendments to the New Substances Notification Regulations (Organisms) [NSNR (Organisms)] versus the current NSNR (Organisms). This information is needed in order for Environment Canada to develop the Regulatory Impact Analysis Statement necessary for publishing the proposed amendments in the Canada Gazette.  In order to determine the costs associated with the proposed regulatory amendments it will be necessary to first gather the metrics and data needed to do so.  This will involve researching and gathering economic data and information on research and development (R&D) activities in the academic and private sectors that deal with both new higher organisms that are genetically modified (i.e. vertebrates and invertebrates but excluding plants) and micro-organisms used in agricultural field trials. The study will provide the New Substances (NS) program at Environment Canada with data and meaningful estimates of compliance and administrative costs for regulatees and the regulator. 


3.0 BACKGROUND

The NSNR(Organisms) exempts new higher organisms from notification prior to import or manufacture when these organisms are used for R&D and meet the criteria as outlined in ss.2(4). These criteria require that the R&D activity involving these organisms fully contain the live organism, its genetic material and any product from the organism that may be toxic to the environment or human health.  This is a very stringent requirement for researchers to meet and at times may be open to interpretation. Currently, there is no requirement for the researcher to inform (i.e. report to) the NS program that they are using the exemption 

Following several multi-stakeholder consultations, Environment Canada and Health Canada are proposing regulatory amendments to: 1) improve the clarity of the exemption criteria, 2) require appropriate containment for the organism and 3) require regulatees to report their determination that the exemption criteria are met.  These changes will have the effect of requiring the R&D sector to be more explicitly and transparently involved in managing their research animals and their potential risks.  Wherever possible, the use of existing reporting systems should minimize impacts on regulatees.  This approach will provide regulatees with explicit duties (reporting) which will not only re-enforce and encourage “self-management” of potential risks but also enhances the Government’s understanding of the types of activities that are taking place in Canada and provides for an opportunity to intervene should that be necessary.

In addition to the above proposed amendments, Environment Canada and Health Canada are proposing to add a number of new schedules under which importers or manufacturers of new higher organisms can notify.  By doing so, notifiers will now have the option to notify under a Schedule with information requirements tailored to their activity (for example, field trials or a release under confined conditions). 

Finally, amendments are also being proposed to exempt research activities involving the use of naturally occurring micro-organisms in agricultural field trials that currently require notification and assessment prior to import or manufacture under Schedules 3 or 4 of the NSNR (Organisms).  The impact of these additional amendments will also need to be considered in the overall net estimates of compliance and administrative costs.


4.0 STATEMENT OF WORK

In order to assist the program with determining the administrative and compliance costs resulting from the proposed amendments,  the contractor will research, gather and provide information and data requested below, and provide the results of its research to the DR in the form of a report.    


4.1 Survey: estimate the number of companies and organizations in the academic, government and industrial R&D sectors that may be affected by the proposed amendments.  Also, include the size of their various research programs (number of persons involved and monetary value) and the type of organisms used (insects, mammals and fish are thought to be the most common types of animals; also include micro-organisms used in agricultural field trials for the second amendment) 
The contractor must provide a clearly designed approach for the identification and enumeration of organizations or companies in the various sectors and describe the method for generating these estimates. The contractor must then apply the agreed upon methodology in generating the estimates in the Preliminary Report (see section 4.2 for additional information).


4.2 Estimate the incremental administrative and compliance costs associated with the amended NSNR (Organisms)  

The contractor must provide a clearly designed approach and methodology for the estimated incremental costs which should include, but is not limited to, both the administrative costs and the compliance costs, and the difference between these costs under the current NSNR (Organisms) and the amended NSNR (Organisms). The contractor may use methods that include, but are not limited to, interviewing a representative sample of regulatees in the various sectors which must reflect the diversity of organizations present in the various sectors and the diversity of organisms used in R&D activities involving genetically modified higher organisms and micro-organisms used in agricultural field trials. The contractor must then apply the agreed upon methodology in generating the estimates in the Final Report. The design and methods to be used for estimating the incremental costs must be approved by the DR before the start of the study.

A Preliminary Report must be submitted to the DR by the end of the 4th week of the contract. This preliminary report will include the results of the survey of the sector (see section 4.1 above) and highlight all progress made in the overall study.  Any changes in the original proposed methodology must be described and justified in the preliminary report and will need the approval of the DR.

A draft of the Final Report must be submitted to the DR by the end of the 18th week of the contract. This draft Final Report must contain all necessary data (including the data provided in the preliminary report) and the economic analysis with clear and complete discussions and conclusions based on the findings.

A Final Report must be submitted by the end of the 24th week of the contract to the DR in two hard bound copies and one electronic copy. This Final Report must have addressed all feedback and questions provided by the DR following the draft of the Final Report and must contain all necessary data and analysis including clear and complete discussions and conclusions based on the findings. 

Bidders shall be capable of writing all reports or documents to be submitted to the Departmental Representative (DR) in one of the official languages (either in English or French);

Bidders shall have working e-mail and Internet connection, along with working telephone and/or cellular phone, and a fax machine to facilitate the exchange of non-sensitive materials;

Bidders shall have a personal computer and the appropriate hardware and software to deliver all services as stated in the RFP and generate all reports in a format fully compatible with Microsoft Office 2003.


5.0 GENERAL INSTRUCTIONS

The contractor is required to follow these general instructions:

1.	In conducting the research, consult with and reference additional supporting data from various sources including, but not limited to;
o	Government reports 
o	Interviews with industry representatives upon the DR’s approval
o	Reports and studies from other relevant groups
o	Internet research
o	Other sources as identified during the course of this research. 

2. Use of Canadian data should be prioritized over those from other sources.

3. The Contractor shall report all the sources of information.

4. All reports (either in draft or final form) shall be written in clear, concise, and logical fashion.  


5. All supporting and underlying data (raw data) should be provided in MS Word, MS Access or MS Excel format.

6. Where it is necessary to identify trends, data and information are to be used from at least the last five years of availability.

7. All monetary values will be expressed in Canadian dollars, with the source year the most recent possible and readily visible. Instances of currency conversion will be identified and accompanied by an explanation of the exchange rate used.  Units will always be clearly indicated, and converted for easy comparability whenever possible.

8. Where data gaps exist reasonable assumptions/estimations should be included to fill these gaps. These assumptions, and the basis for any estimates, should be clearly described and justified.

9. Regular feedback through email, and/or phone calls (approximately every 2 weeks to 3 weeks or earlier as required) shall be maintained between the Contractor and the DR. 

10. The Contractor is encouraged and expected to provide any additional information discovered during the Contract period that is deemed relevant in fulfilling the objectives of this Contract. 

11.  The report will include, but not be limited to, the information identified above.  If a particular requirement for information, or aspect thereof, cannot for any reason be fulfilled, an explanation in writing, to the satisfaction of the DR, is required.



6.0 RETURN/DESTRUCTION OF INFORMATION

The information and documentation provided to the Contractor are to be used for the purpose of this Contract only and shall not be used for other purposes unless duly authorized by the DR. The information should be destroyed in a manner deemed appropriate by the DR upon request. 


7.0 SCHEDULE AND DELIVERABLES                                                    

•	The major deliverables are identified as:
o	One Preliminary Report
o	One Draft Final Report 
o	One Final Report

•	Regular feedback through Email, phone calls and/or meetings shall be maintained between the contractor and the DR.

•	A progress report shall be submitted every 2 weeks, to inform the department of the progress on the project.

Deliverables and Milestones	Time from Contract signing	Environment Canada Review period
Contract signing	Day 1 of Contract	
Kick-off meeting	Week 1	
Outline and Approval of Methodology	Week 1	1 week
Preliminary Report	Week 4 	1 week
Draft Report 	Week 18	2 week
Final Report	Week 24	2 week
Project termination	Week 26	

	Proposed timelines
	Week 1-4	Week 5-17	Week 18-23	Week 24-26
Submit Outline of Methodology for approval	 			
Industry and Government Survey	 			
Submit Preliminary Report	 				
Data Gathering
		 		
Analysis and Report-writing		 			
Submit Draft Report			 	
Submit Final Report				 

•	The contractor shall submit two hard bound copies and one electronic copy of the final report.   The contract starts on signature.

•	The Preliminary Report shall be provided no later than the last day of the 4th week of the project and all other deliverables shall be provided no later than the last day of the 24th week of the project.  

•	In addition to the final report, the Contractor will provide the DR with:
o	Hard and electronic (Microsoft Word and Excel, version 7.0 or later) copies of all notes, text, graphics, surveys, raw data, and spreadsheets used for the delivery of this Contract.
o	No copies (hard or electronic) of documents/information provided by Environment Canada are to be retained by the Contractor.

8.0 ACCEPTANCE

All documents and correspondence produced by the Contractor will be subject to review in draft form by the DR or designated persons. All work is to be performed to the satisfaction of the DR. Sufficient flexibility is required of the contractor to respond to changing schedules and developments.

The contract may not be awarded if only one acceptable bid is received.


9.0 PROJECT BUDGET

Funding for this project has been established at a maximum of $35,000, excluding applicable taxes.