Movento, Movento OD and Movento 100SC insecticides containing spirotetramat.

Transcription

1 DECISION 26 October Summary Substances Application code Application type Applicant Purpose of the application Movento, Movento OD and Movento 100SC insecticides containing spirotetramat. APP To decide whether there are grounds for reassessment under the Hazardous Substances and New Organisms Act 1996 National Beekeepers Association of New Zealand Technical Committee To determine if there are grounds for the reassessment of Movento, Movento OD and Movento 100SC insecticides containing spirotetramat. Date application received 30 August 2012 Consideration Date 26 October 2012 Considered by A Decision-Making Committee of the Environmental Protection Authority (EPA) Damian Stone (Chair) Dr Val Orchard Dr Kevin Thompson Decision Grounds exist for reassessment 2. Application process Terms used in this document 2.1. For the purposes of this document, the term HSNO refers to the regime that consists of the Hazardous Substances and New Organisms Act 1996 and its associated regulations A full glossary of units of measurements and technical terms used in this document is attached as Appendix A.

2 Page 2 of 8 The applicant and the application 2.3. The National Beekeepers Association of New Zealand Technical Committee (the applicant) has made a request of the EPA, under section 62 of the Hazardous Substances and New Organisms Act 1996 (the Act), to decide whether there are grounds to reassess the substances Movento, Movento OD and Movento 100SC insecticides containing spirotetramat (approval codes HSR007963, HSR and HSR respectively) The applicant has provided information suggesting that the systemic nature of these insecticides results in significant levels of the active ingredient spirotetramat in the pollen of sprayed kiwifruit vines, where it poses non-negligible risks to bees The new information is provided by way of a presentation reviewing the current status of Movento worldwide, and a report on the analysis of kiwifruit pollen for spirotetramat residues; the details of which are discussed further in Section 4 of this document The applicant has provided this information to support the addition of a 9.4 HSNO classification (terrestrial invertebrate ecotoxicity) to the substances Movento, Movento OD and Movento 100SC. The applicant has also requested that additional controls to manage the risks to bees be added to the Movento approvals; i) When used in fruit crops; Do not spray until petal fall and that this is clearly stated on the label. ii) Warning that this product is toxic to bees when applied during flowering of the crop, as per the warning required in Canada The request was made to the EPA, on 30 August 2012, and will be considered by the Decision-Making Committee (the Committee) on 26 October The Committee referred to in this decision is the subcommittee that has made the decision on this application under delegated authority in accordance with section 18A of the Act. The legislative criteria 2.9. Section 62 of the Act allows the Committee to decide if grounds exist to reassess the substance approvals for Movento, Movento OD and Movento 100SC, after taking into account; section 62(2)(a), significant new information relating to the effects of the substance; section 62(2)(b), information to show another substance with similar or improved beneficial effects; and reduced adverse effects has become available, or; section 62(2)(c), information showing a significant change of use, or a significant change in the quantity manufactured, imported or developed has become available Following a decision under section 62(2), the EPA is required to provide its decision, with reasons, to the applicant. If approved, the applicant, any other person, or the Chief Executive (CE), may request the EPA proceed with the reassessment under section 63 for a reassessment of all aspects of the substance approvals.

3 Page 3 of Alternatively, following a decision under section 62(2), the EPA may carry out the reassessment in accordance with section 63A (where only a specific aspect of the approval may be modified), if they believe that a reassessment under section 63 is not appropriate because the reassessment will involve only a specific aspect of the approval (and the amendment is not minor or technical in effect) The purpose of this application is to obtain a decision as to whether grounds for reassessment exist under section 62 on the basis that there is significant new information relating to the effects of the substances Movento, Movento OD and Movento 100SC. 3. Background The substances 3.1. The substances Movento, Movento OD and Movento 100SC were approved under Part 5 of the Act in August 2008, October 2010 and June 2011 respectively The substances Movento, Movento OD and Movento 100SC are registered to Bayer CropScience under the Agricultural Compound and Veterinary Medicines Act 1997 (ACVM Act), and are used as insecticides Details for these substance are as follows: Trade name Active ingredient HSNO Approval Number Movento 240 g/l spirotetramat HSR (August 2008) Movento OD 150 g/l spirotetramat HSR (October 2010) Movento 100SC 100 g/l spirotetramat HSR (June 2011) ACVM Registration Number P (September 2008) P (December 2011) P (October 2011) End Use To control armoured scales in kiwifruit and tomato/potato psyllid in field tomatoes and potatoes. To control tomato/potato psyllid in field tomatoes and potatoes. To control apple leafcurling midge and armoured scales in apples and armoured scales in kiwifruit. Substance classifications 3.4. Currently, within the EPA substance database, the substances Movento, Movento OD and Movento 100SC are assigned the following HSNO classifications: Classification Movento Movento OD Movento 100SC Acute toxicity (oral) 6.1E Eye irritancy 6.4A 6.4A -- Contact sensitisation 6.5B 6.5B 6.5B

4 Page 4 of 8 Reproductive/ developmental toxicity 6.8B 6.8B 6.8B Reproductive/ developmental toxicity (via lactation) C -- Target organ systemic toxicity B -- Aquatic ecotoxicity 9.1B 9.1B 9.1C Terrestrial vertebrate ecotoxicity 9.3C When the substance Movento was first assessed and classified by the staff, a 9.4 classification for terrestrial invertebrate ecotoxicity was not assigned as the applicant provided formulation data for the effects of the substance on bees which did not support classification in accordance with the Hazardous Substances (Classification) Regulations The substance controls 3.6. The substance approvals for Movento, Movento OD and Movento 100SC specify a set of controls (obligations and restrictions) under the Act that must be complied with. These controls are based on the hazard profiles of the substances and can be viewed on the EPA website controls database () If a terrestrial invertebrate ecotoxicity classification (hazard class 9.4) was added to these substances, there would be an effect on the HSNO controls associated with the substance. The most notable change to controls would be the addition of the requirements of Regulation 49 of the Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations Regulation 49 reads; (1) A person must not apply a class 9.4 substance in an application area (a) if bees are foraging in the area and the substance is in a form in which bees are likely to be exposed to it; or (b) to any plant or tree that is likely to be visited by bees if (i) the plant or tree is in open flower or part bloom; or (ii) the plant or tree is likely to flower after application of the substance within a period specified by the Authority. (2) The period specified by the Authority must not be longer than 10 days If a terrestrial invertebrate ecotoxicity classification (hazard class 9.4) was added to these substances, depending on the degree of hazard e.g. 9.4A, 9.4B or 9.4C, there may also be more stringent HSNO requirements around keeping records of use as well as additional approved handler/security requirements when the substances are applied by a commercial contractor or in a wide dispersive manner A full assessment of any resulting changes to controls would be carried as part of a reassessment.

5 Page 5 of 8 4. Information provided by the applicant Summary of information provided 4.1. The applicant has provided the following information to support the claim that Movento insecticides containing spirotetramat are toxic to bees; McLean (2012), Who s looking after our Apis canary in the systemic agrichemical coal mine? presented to the EPA in June This presentation includes reference to several other sources which have also been provided; o LeConte et al. (1994), The Recognition of Larvae by Worker Honeybees. Naturwissenschaften 81, o LeConte et al (2006), Larval salivary glands are a source of primer and releaser pheromone in honey bee (Apis mellifera L.). Naturwissenschaften 93: o Bonmatin J.M. (2009), Conclusions Round Table on intoxication of bees due to pesticides: results from scientists, presentation at 41th Apimondia Congress September 2009, Montpellier o OECD Joint Review Spirotetramat (2008) o Novachem Agricultural Manual (2012) Pages o European Food Safety Authority (2012), Scientific Opinion on the science behind the development of a risk assessment of Plant protection Products on Bees (Apis mellifera, Bombus spp. and solitary bees). EFSA Journal; 10(5): pp. Slessor et al (2005), Pheromone communication in the honeybee (Apis mellifera L.). Journal of Chemical Ecology 31(11): Brűck et al (2009), Movento an innovative ambimobile insecticide for sucking insect pest control in agriculture: Biological profile and field performance. Crop Protection 28: Certificate of Analysis (2012) AsureQuality 4.2. The McLean (2012), presentation provides information about the current status of Movento worldwide, including publications from the EU regulatory body EFSA and an OECD joint review on Movento s active ingredient spirotetramat. The information can be considered new, as the studies referenced were published after Movento was approved in 2008, or were not provided during the approval of the substances The Slessor et al (2005), study provides background information on pheromones used by honey bees for chemical communication and regulation of in-hive processes. There is concern that Movento products may disturb these processes, which are regulated by fatty acid esters, due to the mode of action of spirotetramat as a lipid biosynthesis inhibitor. While this study pre-dates the 2008 approval of Movento, it is considered to be significant new information affecting the Movento substance approvals The Brűck et al (2009), study describes the effects of Movento on resistant whitefly populations, detailing its effects on other insects.

6 Page 6 of The certificate of analysis, carried out by AsureQuality demonstrates the level of spirotetramat residues in kiwifruit pollen from a Gisborne orchard. Evaluation against the criteria in the Act Section 62(2)(a): Significant new information relating to the effects of the substance has become available 4.6. The Committee considers that the information provided to the EPA is significant in relation to the effects of the substances Movento, Movento OD and Movento 100SC, and was not considered during the approval of the substances. Section 62(2)(b): Another substance with similar or improved beneficial effects and reduced adverse effects has become available 4.7. This ground is not relevant to this request. Section 62(2)(c): Information showing a significant change of use, or a significant change in the quantity manufactured, imported, or developed has become available 4.8. This ground is not relevant to this request. Other factors 4.9. The Committee notes that the applicant has only provided information regarding a particular aspect of the Movento, Movento OD and Movento 100SC approvals (relating to the terrestrial invertebrate ecotoxicity hazard) The Committee also notes that information considered in a reassessment is not limited to that which is presented in this grounds decision When notified of this application to decide whether there are grounds for the reassessment of Movento, Movento OD and Movento 100SC insecticides containing spirotetramat, Bayer CropScience has provided comment on the application; Bayer will no longer be selling the formulation named Movento (240g/L spirotetramat) and will only, in the future, be selling Movento OD (150g/L spirotetramat) and Movento 100SC (100g/L spirotetramat). The current label recommendations are to apply either before flowering of the particular crops or in the case of apples, sometime after flowering leading up to 35 days prior to harvest. Given that the applicant is suggesting warnings on the label in regard to not using over the flowering period, this does not seem relevant as the product is not recommended to be applied over the flowering period to any of the crops listed on the Movento product labels The Committee notes that the proposed additional control Do not spray until petal fall would prevent application of the substances to crops before flowering, as well as during the flowering period.

7 Page 7 of Bayer also supplied the following information; Bayer information sheet, Field investigations that demonstrate the safety to honey bees of Movento applied to citrus at bloom. Bayer technical information on Spirotetramat, Movento Maus (2008), Ecotoxicological profile of the insecticide spirotetramat OECD Joint Review spirotetramat (2008) Addendum Volume 3, Annex B Issues and concerns to Māori The Committee has considered Māori perspectives regarding the applicant s wish to determine whether there are grounds for the reassessment of the substance The Committee conclude that if grounds exist for a reassessment, and a subsequent reassessment is applied for, wider public notification and/or consultation will be undertaken, including with Iwi/Māori. 5. Consideration 5.1. The Committee considers that there is significant new information relating to the effects of the substances Movento, Movento 100SC and Movento OD on bee populations, and that this can be considered grounds for a reassessment of these substances Accordingly, the Committee considers that grounds exist to reassess the Movento, Movento 100SC and Movento OD approvals. This decision is made under section 62(2) of the Act. Signed by Date: 26 October 2012 Damian Stone Chair, Decision Making Committee Environmental Protection Authority

8 Page 8 of 8 Appendix A - Glossary of terms The Act Hazardous Substances and New Organisms Act 1996 APP Approval Approval number EPA substance application code HSNO substance approval A unique number beginning with HRS; allocated to a substance when it is approved under HSNO AVCM Act Agricultural Compound and Veterinary Medicines Act 1997 CAS Number The committee CE CEIR Classification EC 50 EPA g/kg HSNO HSR Inventory Oscar ID Reassessment Transferred A unique number allocated to a substance by the Chemical Abstracts Service, a division of the American Chemical Society Decision-Making Committee; a subcommittee that has made the decision on this application under delegated authority in accordance with section 18A of the Act Chief Executive of the EPA The Chief Executive Initiated Reassessment list is a non-statutory list of existing substances that the Chief Executive wishes to reassess when the opportunity becomes available In this document, classification refers to the HSNO classification assigned to a substance when it is approved under HSNO Half maximum effective concentration Environmental Protection Authority Grams per kilogram Hazardous Substances and New Organisms Act 1996 and its associated regulations Refers to a HSNO approval number assigned to a substance when it is HSNO approved Refers to the EPA substance database (also called Oscar) Unique number assigned to a substance when it is entered into the EPA substance database Refers to the process of reassessing information relating to a substances HSNO approval, and modifying the approval if necessary. Refers to the process carried out when the HSNO Act replaced old legislation. Existing substances where transferred into the HSNO Act and given a deemed approval.