Dermal Absorption Testing of Existing and New Priority Chemicals under the Chemicals Management Plan

NOTICE OF PROPOSED PROCUREMENT (NPP)

Solicitation #: 1000180299 Closing Date: July 15, 2016 Time: 2 p.m. EDT

This requirement is for the department of Health Canada.

Title:

Dermal Absorption Testing of Existing and New Priority Chemicals under the Chemicals Management Plan

Scope:

Health Canada is responsible for helping Canadians protect, maintain, and improve their health, while respecting individual choices and circumstances. To achieve this goal, Health Canada relies on high-quality scientific data as the basis for its work.

The Canadian Environmental Protection Act, 1999 (CEPA 1999) required the Ministers of the Environment and of Health to categorize all substances on the Domestic Substances List (DSL) that are persistent and/or bioaccumulative based on the Persistence and Bioaccumulation Regulations, are inherently toxic to humans or other organisms, or that present the greatest potential for human exposure in Canada. Substances found to meet the categorization criteria are subject to a screening assessment and, if determined to meet the criteria under section 64, may be subject to risk management measures. The Government of Canada completed this categorization exercise in 2006. Of the approximately 23,000 substances subject to categorization, about 4,300 were identified as priorities for further action. These substances became a focus for further work under Canada’s Chemicals Management Plan (CMP), launched on December 8, 2006. The Ministers of the Environment and of Health have committed to addressing these substances by 2020, to ensure that chemicals are produced and used in ways that minimize significant adverse impacts on human health and the environment.

Of the 4,300 substances identified as priorities for further action, approximately 2,800 have been addressed in the first and second phases of the CMP. The Government of Canada is currently launching the third phase during which approximately 1,500 substances will be addressed.

As part of an initial screening of the substances to be addressed in the third phase of the CMP, the Existing Substances Risk Assessment Bureau (ESRAB) has determined that several of these substances (listed below) are present in personal-care products, cosmetics, paints, or household cleaning products and are potentially associated with high hazard. As well, the Consumer Product Safety Directorate (CPSD) has occasional need for data on dermal absorption which can be a main route of exposure to these substances. Often, data on chemical-specific dermal absorption are not available. Additional data would aid in refining certain assessments as well as enhancing the confidence of modelled dermal absorption predictions.

As the Healthy Environments and Consumer Safety Branch lacks the capacity to perform dermal absorption testing internally, Health Canada is seeking the services of a Contractor for the undertaking of laboratory studies to investigate the dermal absorption capabilities/potential of prioritized chemical substances. The results of this study will support risk assessment activities under the CMP.

Objectives of the Requirement

The main objective of the requirement is to test the dermal absorption capabilities of identified priority substances in support of risk assessment activities under the CMP. The ultimate goal of the study is to generate data to derive dermal absorption rate for the specified chemicals. The study data and results provided by the Contractor will be evaluated by Health Canada for accuracy, appropriate quality assurance/quality control (QA/QC) measurements employed, and reporting standards.

Estimated Value:

The estimated total value of this requirement is not expected to be more than $800,000 including a one-year option period.

Ownership of Intellectual Property:

The Contractor will own the Intellectual Property, while the Crown will have an irrevocable, royalty-free licence to use the IP.

Security Requirement:

There is no security requirement.

Mandatory Requirements:

M1. Good Laboratory Practice (GLP) Compliance

The bidder is required to be GLP compliant as recognized by the respective national GLP compliance monitoring authority.

M2. Performance, reliability and reproducibility

The bidder is required to demonstrate the performance, reliability and reproducibility of the test methodology in the performing laboratory.

M3. Ability to acquire and handle radiolabelled chemicals for testing

The bidder is required to demonstrate the ability to acquire and handle radiolabelled chemicals for testing.

M4. Ready access to human skin and Research Ethics Board approval

The bidder is required to demonstrate the ready access to human skin.

M5. Experience with testing human skin integrity

The bidder is required to demonstrate experience with appropriate methodology to test the skin integrity as specified within SCCS 2010.

M6. Recent Dermal Absorption Testing Experience

The bidder must demonstrate recent (within last 2 years) experience performing in vitro dermal absorption testing using human skin.

Selection Methodology

The responsive bid with the highest combined rating of technical merit and price will be recommended for award of a contract.

Enquiries regarding this Request for Proposals are to be submitted in writing to:

Robert Merrick

Contracting Authority

E-mail: Robert.Merrick@hc-sc.gc.ca