The Authority has delegated powers to IBSCs to make amendments to decisions under Section 67A of the HSNO Act. Section 67A may be invoked to change the controls on a containment approval, to clarify the description of the new organism which is the subject of the containment approval, or to modify other aspects of the approval.
Section 67A may also be used to exclude an organism which is currently included in an approval, but may not be used to add new organisms to an approval. In the latter case a new Part V application should be made.
Basis for distinguishing between "minor in effect" and "minor or technical error"
Minor in effect
If a proposed change does not conform to the criteria for a "minor or technical error", then it must be "minor in effect" to be considered under s67A. When determining whether or not a change is "minor in effect" the following should be considered:
How minor is "minor"?
For variations in the description of approved organisms, minor should be interpreted as outlined in the section above. For variations in controls minor should be generally interpreted as not creating any variation in residual risk, ie the risk after applying controls, or in the costs of using the approval, to a degree that any reasonable person would regard as significant or noticeable. It is hard to be more precise than this, and it could be that the best way to handle the matter is to create precedents by looking at actual cases.
Minor or Technical Error
A change can be considered to correct a "minor or technical error" under the following circumstances:
- If information that was available to the IBSC at the time the decision was made, was inadvertently overlooked or misinterpreted in a way that is reasonably obvious on re-examination, and leads to a corresponding change in the approval;
- If it is evident from the context, ie the surrounding language in the approval and/or application that a straight error has occurred, eg, misplacement of a decimal point, use of the wrong units, wrong cross-reference, an incorrect chemical name or formulation, a typographical error, and so on.
These circumstances are expanded upon below.
However, a change is NOT to be described as a or technical error if it is the result of a fresh or revised interpretation of existing information, which leads to a different outcome in terms of risks, controls, etc. There is a clear difference between a NEW interpretation and a MISinterpretation.
Minor errors
In determining if an error is minor the relevance of the error to the decision made and to the level of risk management imposed needs to be assessed. If the error would not have resulted in a different decision being made and does not materially affect the approach to risk management set out in the controls, then the amendment can be made as a "minor error" change.
"Minor error" changes may be used to correct errors in the formal identity of an organism. If the identification can be corrected without changing the identity then this would constitute a "minor error" change. Examples of this are where a taxonomic reference has been updated or misquoted.
Technical errors
Changes to controls that correct technical errors can be made under this policy. The provision in the Act does not restrict the interpretation of a technical error to being minor. A practical interpretation of "technical" should therefore be applied. It is envisaged that technical changes would include:
- changes to correct controls that through a misunderstanding or error in drafting are impractical, unworkable or difficult to enforce and require only an adjustment to existing controls;
- errors in consistency between the decision and the controls. Such changes would be limited to the need to ensure that the controls accurately reflect the decision. This may require the addition of new controls;
- obvious typographical and drafting errors such as mistakes in the nomenclature of organisms or misstatement of units.
It is stressed that changes promoted under this part of the policy should be solely for the purpose of correcting errors.
Circumstances where both criteria or either might apply
There will probably be circumstances where both or either criteria may apply. If in doubt the criterion of minor in effect should be applied because this is probably safer.
Example:
An example is where a gap in the controls becomes evident because of an oversight during the decision making process, or perhaps because of the insights gained by handling other similar applications. An amendment to include a new control or set of controls would best be considered under the "minor in effect" criterion, and this would be acceptable if:
- the amendment did not result in an increase in the acceptable level of risk stated or implied in the decision to increase. For example if the risks were originally determined as being minor, they remain so after providing for the oversight through an addition to the controls; and
- to maintain the acceptable level of risk the new control or controls are narrowly focused on a specific area of risk management, ie the controls are not wide ranging covering many aspects of risk management.