An application for reassessment was prepared by EPA staff on behalf of the Executive Director pursuant to section 63 of the Act. The application for reassessment was submitted pursuant to section 63 of the Act and, as required by that section, deemed to be an application submitted under Section 29 of the Act. The processing of the application followed the relevant sections of the Act and the decision-making method set out in Section 9 of the Act.
Pursuant to section 53 of the Act, the application was notified publicly on the EPA website on 25 August 2015. The Minister for the Environment was notified of the application in accordance with section 53(4)(a) on 25 August 2015. of the Act. A deliberation meeting was convened in accordance with section 60 of the Act and clause 2(b) of the HSNO methodology.
Under section 8 of the Hazardous Substances and New Organisms Act (1996), all persons exercising powers and functions under the Act must have regard to the principles of the Treaty of Waitangi (Tiriti ō Waitangi). In relation to the principles of the Treaty of Waitangi, the Committee focused its attention on the generally accepted principles of partnership, participation and protection. The committee considered the written submission from Dr Oliver Sutherland on behalf of the Ngāi Tahu HSNO committee.
As part of the reassessment, EPA staff reviewed the HSNO classifications for CCD and formulations containing these substances.
Assessment of benefits
Summary
Introduction
Benefits from veterinary use
Benefits from TopClip
Benefits from diazinon flea collars for cats and dogs
Benefits from carbaryl based ear drops – Fido’s Ear Drops
- Benefits from non-plant protection use
- Human health benefits
- Benefits to Māori
- Benefits to society and communities
- Assessment of adverse effects
- Summary
- Risk Assessment
- Adverse effects on human health
Carbaryl, chlorpyrifos and diazinon, carbamate and organophosphates are known to be toxic to humans and the environment. The general effects of OPC were discussed in EPA's OPC Reevaluation Decision (APP202142) and are relevant here as well. EPA staff have conducted a human health and environmental risk assessment for CCD-containing substances used in New Zealand.
The data related to the toxicological and ecotoxicological effects are based on human or animal studies. Where possible, the toxicity and ecotoxicity data specific to the substances evaluated are those used by other international regulators. In some cases, key information relevant to the risk assessment, such as monitoring studies on exposure of a higher level operator or re-entry of workers or dermal absorption data, was not available.
In these cases, EPA staff followed international practice and used reasonable worst-case scenarios or defaults, or did not calculate the risks. To allow a comparison between the benefits and the risks associated with the application of CCD-containing substances, qualitative descriptors were used that classified the level of risk into broad categories: negligible, low, medium or high. Consistent with EPA methodology, these descriptors explain the likelihood and magnitude of an adverse effect.
Full details of the risk assessment approach and results can be found in the filing and the EPA personnel update report. The committee reviewed the human health effects described in the application and further refined in the Staff Update Report. The Committee noted that the use of these substances, with the exception of carbaryl-based ear drops, poses risks to human health that are significantly in excess of an acceptable level of concern.
The Committee questioned the fact that the Australian Pesticides and Veterinary Medicines Authority's review of the adverse effects of flea collars on human health had not shown any risks to human health. EPA staff responded that there appeared to be no quantitative risk assessment included in that Australian review.
Acute poisoning
Chronic health effects
- Adverse effects on the environment
- Adverse effects on the relationship of Māori to the environment
- Adverse effects on society and communities
- Withdrawal of products from the market
- International obligations
- Overall evaluation of effects
- Introduction
- Summary and conclusions
- Decision
- Review the content of the application and all relevant information
- Is this information sufficient to proceed?
- if ‘no’ from item 2) Seek additional information
- Sufficient?
- If ‘yes’ from item 2 or from item 4) Identify the composition of the substance, classify the hazardous properties, and determine default controls
- Identify all risks, costs and benefits that are potentially non-negligible 3
- Undertake combined consideration of all risks and costs, cognisant of proposed controls Once the risks and costs have been assessed individually, if appropriate consider all risks and costs
- Are all risks with controls in place negligible?
- Is it evident that benefits outweigh costs?
- Review controls for cost-effectiveness in accordance with clause 35 and sections 77, 77A and 77B
- if ‘no’ from item 11 or in sequence from item 13) Assess benefits Assess benefits or positive effects in terms of clause 13 of the Methodology
- Taking into account controls, do positive effects outweigh adverse effects?
- Commencement—
- Interpretation—
- Prohibition on use—
- Controls on substances containing carbaryl, chlorpyrifos and diazinon until 3 years hence
- Controls on the disposal of substances containing carbaryl, chlorpyrifos or diazinon—
Many of the substances listed in the application have already been voluntarily withdrawn from the market. The Committee therefore considered this substance by means of clause 27 of the Methodology, and the Committee was of the opinion that the risks outweighed the benefits. The Committee considered their decision through clause 27 of the Methodology and considered that the risks outweighed the benefits.
The Committee assessed these substances through clause 27 of the Methodology and considered that the risks of all of these substances outweigh the benefits of these products. That notification specifies the controls related to the use/disposal of the substance for 3 years. This application is made under Section 63 (Reassessment) of the HSNO Act and determined under Section 29 of the Act.
The purpose of the decision process is to provide the HSNO decision-maker2 with guidance so that all relevant matters from the HSNO Act and the Methodology are discussed. Identify the composition of the substance, classify the hazardous properties of the substance and define standard controls. While the HSNO decision-maker will consider all relevant information, his primary interest is in information relevant to the proper handling of the application; i.e.
Identify the composition of the substance, and establish the hazard classifications for the identified substance. Consider the effects of the substance throughout its life cycle (clause 11) and include the likely effects of the substance being unavailable (sections 29(1)(a)(iii) and 29(1)(b)(iii)). Where all risks are negligible, the decision must be made in terms of clause 26 of the Methodology.
Consider the practicality and cost-effectiveness of the proposed individual controls and exposure limits (clause 35). This constitutes a decision taken according to point 27 of the Methodology (taken in order from points 9 and 12). This assessment also includes consideration of the HSNO decision maker's approach to uncertainty or how cautious the HSNO decision maker will be in the face of uncertainty (section 7).
Pursuant to section 66 of the Hazardous Substances and New Organisms Act 1996 ("the Act"), the Environment Protection Authority issues the following notice. Risk The combination of the magnitude of a negative effect and the probability of its occurrence.
Tolerable Exposure Limits
Changes are noted where new controls or versions are introduced and include the dates when the changes take effect.
Substances (Classes 6, 8, and 9 Controls) Regulations 2001
Hazard
Classification Liquid
L) Solid (kg)
- of the Hazardous
- sub clauses (1) and (2) are deleted
- of the Hazardous Substances (Identification) Regulations 2001
- of the Hazardous
A dangerous substance must be identified by a statement that it is ecotoxic when the amount of the substance in a package is greater than or equal to 100 ml I9 Reg 18 Secondary.
Substances (Identification) Regulations 2001
This variation takes effect on 1 January 2018
Packaging requirements for toxic substances (class 6)
This control takes effect on 1 January 2018
Regulation 8(f) of the Hazardous
Substances (Emergency Management) Regulations 2001
- information
- of the Hazardous
- Level 3 emergency
- of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004
- Schedule 8
For the purposes of this regulation and regulations 37 through 40, where this. dust is contained in pipes installed and used in such a way as to prevent any loss of containment in the pipes. a) is not taken into account when determining whether a site must have a secondary containment system; And.
