Appendix 6: Proposed Requirements for Non-GLP Studies

It has been proposed by the Table (see Section 3.1.6(iii)) that requirements pertaining to GLP for tests for physical/chemical properties be separated into two provisions, one of which must be met. The first, that tests for physical/chemical properties "comply with OECD GLP for 'short-term' tests or equivalent GLP regulations," is self-explanatory, and the second, that such tests "provide enough information to demonstrate the reliability and adequacy of the data," will be elaborated upon below.

During the course of an evaluation, information pertaining to how the test was conducted, deviations from standard protocols, handling of data, etc. is necessary for an evaluator to determine the reliability and adequacy of data received.

The type of information needed (most of which was extracted from reporting requirements of GLP) should include, where relevant for the test method:

• identification of the test guideline and methodology used;
• identification of the test substance and its purity;
• reference methods, standards and controls employed;
• name and address of the test facility, and person responsible for the data;
• dates on which the study was initiated and completed;
• raw data;
• deviations from standard protocols;
• analytical details, including sample preparation, instrument settings and calibration standards and methods; and
• a detailed presentation of results, calculations and statistical methods.

Revised guidelines will articulate the type of information required to demonstrate the reliability and adequacy of test data. It is intended that this would alert notifiers to the potential need for submitting these data. Notifiers will be advised to contact the program for a pre-notification consultation to discuss any potential issues.

As is current practice, in cases where the information submitted is deemed by an evaluator(s) not to be sufficient, notifiers will be advised to request that the assessment time clock be stopped (i.e., the assessment is suspended) until the information is supplied. If the information is not forthcoming from the notifier, the notification package will be considered incomplete and sent back to the notifier.