: Development of Biomonitoring Equivalents (BE) and methods for high throughput risk assessment

HEALTH CANADA ADVANCE CONTRACT AWARD NOTICE


TITLE:   Development of Biomonitoring Equivalents (BE) and methods for high throughput risk assessment

SOLICITATION NUMBER:   1000165055

1.  The purpose and explanation of an ACAN

An Advance Contract Award Notice (ACAN) allows Health Canada contracting authorities to post a notice on the Government Electronic Tendering System (GETS), for no less than fifteen (15) calendar days, indicating to the supplier community that a good, service or construction contract will be awarded to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the requirements set out in the ACAN, the contracting authority may then proceed with the award. However, should a Statement of Capabilities be found to meet the requirements set out in the ACAN, then the contracting authority will proceed to a full tendering process.

2.  Rights of suppliers

Suppliers who believe that they are fully qualified and available to provide the services or goods described in this ACAN may submit a Statement of Capabilities clearly demonstrating how they meet the advertised requirement. This Statement of Capabilities must be provided via e-mail only to the contact person identified in Section 12 of the Notice on or before the closing date and time of the Notice. If there is a reasonable level of evidence regarding capability, the requirements will be opened to electronic or traditional bidding processes.

3.  Proposed Contractor

Summit Toxicology, L.L.P.
P.O. Box 427
Allenspark, Colorado  80510
USA

4.  Definition of Requirements or Expected Results

Biomonitoring efforts have produced continually expanding databases of the levels of chemicals
that have been measured in the blood and/or urine of Canadians. Such biomonitoring surveys
provide a wealth of information on the levels of chemicals that are found within the general
population; however, the presence of a chemical within the body does not necessarily indicate
there is the potential for harm. A concept known as Biomonitoring Equivalents (BE) has been
developed to aid in interpreting and communicating biomonitoring results in the context of
potential risks to health. A BE is defined as the concentration of a chemical in blood or urine that
corresponds to an exposure guidance value, such as a reference dose (RfD) or tolerable daily
intake (TDI). By comparing biomonitoring data for a chemical with its BE, one can assess
whether population exposures to the chemical are below or above a level that is not considered
to be harmful.  BEs are designed to leverage existing chemical risk assessments and available pharmacokinetic models and data.  

The objectives of the work to be conducted under this contract are:
a)	To derive BEs for additional priority chemicals to support risk assessment and risk management activities; and, 
b)	To use metabolic parameters in physiologically-based pharmacokinetic (PBPK) models to conduct reverse dosimetry to support generation of predictive toolds for assessing exposure and hazard.

The objectives described above will advance the application of BEs  under the Canadian Federal Government’s Chemicals Management Plan.  Specifically, the development of BEs and associated communication materials for the chosen compounds will assist evaluation programs within Health Canada in assessing the results of the biomonitoring data and contribute to the rational prioritization of chemicals for risk assessment follow up.  The quantitative screening tools provided by the BE approach will assist in addressing public concerns regarding potential public health implications of the results of the biomonitoring programs. This effort will also assist in developing the capacity within Health Canada and among Canadian universities to assist the Canadian Government in interpreting and communicating biomonitoring data.  

The outcome of this project will allow Health Canada to place the results from biomonitoring studies into a public health risk context and to allow the rational prioritization of chemicals for further risk assessment and management actions. The outcome of this project will allow Health Canada to answer the following questions:

	Do the measured levels of specific chemicals in Canadians pose a potential public health risk?
	Which chemicals are of greatest priority for risk assessment follow up for Canadian public health?


5.  Minimum requirements

The main reason for directing this contract is the fact that Summit Toxicology, L.L.P., provided the majority of the intellectual input into the proposal that won funding under the Chemical Management Plan.  In addition to that, any interested supplier must demonstrate by way of a Statement of Capabilities that it meets the following minimum requirements: 

a)	Have relevant experience in the area of Biomonitoring Equivalents (BEs). This experience must be at a level that clearly demonstrates an ability to lead in the development of guidelines intended for the development of Biomonitoring Equivalents; 
b)	Have the expertise necessary for the integration of available pharmacokinetic data with existing Canadian risk assessments; 
c)	Possess the expertise necessary for the selection and prioritization of chemicals selected for BE development; 
d)	Have relevant experience in the development of communications materials that interpret chemical specific human biomonitoring data in a public health risk context using BEs; 
e)	Have relevant experience providing guidance at a senior project level in a similar project; 
f)	Have experience coordinating the collaboration with external Canadian and international stakeholders on a relevant project.


6.  Reason for non-competitive award

Section 6 of the Government Contracts Regulations contains four exceptions that permit the contracting authority to set aside the requirement to solicit bids.  For the proposed procurement, the following exception applies:

(d)	Only One Person or Firm is capable of performing the contract.

An earlier project description with Biomonitoring Equivalents (BE) values for a series of selected chemicals was developed by Summit Toxicology LLP in collaboration with Health Canada for 2008-2011. The current requirement starting 2014 will derive new BE screening values with a whole different series of chemicals that are required by Health Canada regulatory scientists to support risk assessments under the Chemicals Management Plan.

The proposal for this latest requirement was developed through a competitive process with internal and external peer review for funding from the Canadian Federal Government’s Chemical Management Plan.  Summit Toxicology LLP was a key participant in developing the current proposal in conjunction with Health Canada researchers.  The Summit Toxicology provided over 75% of the intellectual input that went into the proposal development.  The Contractor will be doing the critical derivation of the provisional BE values which is the main task and purpose of the study.


7.  Applicable trade agreements and justification for limited tendering or the Procurement Strategy for Aboriginal Business

This requirement is subject to the various trade agreements, including the North American Free Trade Agreement (NAFTA); the Agreement on Internal Trade (AIT); and the World Trade Organization - Agreement on Government Procurement (WTO-GPA).  However, this requirement also meets the conditions for limiting the tendering procedures in accordance with:

I.	AIT, Article 506.12 (b).
II.	NAFTA, Article 1016.2 (b)
III.	WTO-AGP, Article XV
	
which allow for contracts to be directed to a particular firm when the products or services can be supplied only by a particular supplier and no reasonable alternative or substitute exists.
	
This requirement is not subject to the Procurement Strategy for Aboriginal Business.
	

8.  Ownership of Intellectual Property

Intellectual Property shall vest with the Contractor, although the Contractor shall grant the Crown a license to exercise all Intellectual Property Rights in the Materiel for any public purpose.


9.  Period of the proposed contract

The services of the Contractor will be required for a period of approximately 30 months, commencing on or about October 20, 2014 and ending around March 31, 2017.  


10.  Estimated value of the proposed contract
 
The contract will span three fiscal years (FY2014-15,  FY2015-16 and FY2016-17) , with a total value of $295,000, including all applicable taxes.


11. Closing date and time 

The closing date and time for accepting Statements of Capabilities is 14th of October 2014, 2 p.m. EDT).

12.  Contact Person

All inquiries with regard to this Notice must be addressed by e-mail to:

Name:   Robert Merrick
E-Mail:    Robert.Merrick@hc-sc.gc.ca