Please note that this medicine may be available in various strengths for each active ingredient listed above. Packages and Strengths Please consult your physician or pharmacist or product package for this information. Please consult with your doctor for case-specific recommendations. Is Actara 25 Wg Mixture safe while breastfeeding? Yes Can Actara 25 Wg Mixture be used for fungicide and insecticide?
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Conditionally registered uses and data requirements Thiamethoxam Technical and its associated end-use products used as seed treatments and for foliar and soil applications are conditionally registered in Canada. For foliar and soil uses discussed in this document, both pollinator and non-pollinator data requirements were initially required in ERC DACO 9.
List of pollinator data, as revised and found in the most recent section 12 notices, as a condition of registration currently associated with these products. DACO: 8. Required data: A study which determines the concentration of thiamethoxam and clothianidin in nectar and pollen of plants plant fate study.
DACO: 9. For the outcome of the review of the information provided to fulfil the above conditions of registration, refer to Section 4. Re-evaluation and special review of thiamethoxam The re-evaluation of thiamethoxam to assess risks to pollinators was announced in Re-evaluation Note REV, Re-evaluation of Neonicotinoid Insecticides.
This re-evaluation was initiated to assess the potential risk to pollinators in light of international updates to the pollinator risk assessment framework, including information requirements. Data obtained from published literature as well as data received from the registrants, including the information that were required to fulfill the conditions of registration under section 12 DACOs 8.
Health Canada has conducted an assessment of pollinator risk for thiamethoxam, as well as a special review to evaluate the impact of thiamethoxam on aquatic invertebrates. A Proposed Re-evaluation Decision and a Proposed Special Review Decision have been published: PRVD, Thiamethoxam and Its Associated End-use Products: Pollinator Re-Evaluation , summarizes the science evaluation with regards to the potential risks posed by thiamethoxam to pollinators in Canada, as well as proposes strategies to reduce the risks to these pollinators.
PSRD, Special Review of Thiamethoxam Risk to Aquatic Invertebrates: Proposed Decision for Consultation , summarizes the science evaluation with regards to the potential risks posed by thiamethoxam to aquatic invertebrates in Canada, as well as proposes strategies to reduce the risks to these organisms. The continued registration of the products in Table 1 is affected by these re-evaluation and special review proposals, and as a result, some uses are currently proposed for cancellation.
The continued registration of the products in Table 1 and of USCs 5, 13, 14, and 27 of the technical active ingredient thiamethoxam will be subject to the outcomes of the final decisions pertaining to the re-evaluation and special review of thiamethoxam. These consultations are carried out under either 28 1 a or under 28 1 c of the Pest Control Products Act see Table 1. Note that consultations under 28 1 c are not subject to subsection 35 1 of the Pest Control Products Act.
An evaluation of available scientific information found that: For USC 5 greenhouse peppers , the product has value and presents an acceptable risk to human health and the environment, when used according to the proposed conditions of registration, which include amendments to the label.
To address potential risks to pollinators and aquatic invertebrates, amendments to the registration of the end-use product have been proposed. For USCs 13, 14 and 27, for the time period of the registration, the products have value and present an acceptable risk to human health and the environment, when used according to the proposed conditions of registration, which include amendments to the label.
To address potential risks to pollinators and aquatic invertebrates, some uses are currently proposed for cancellation and amendments to the registrations of the end-use products have been proposed. The continued registration of the products in Table 1 will be subject to the outcomes of the final decisions pertaining to the re-evaluation and special review of thiamethoxam.
This summary describes the key points of the evaluation of thiamethoxam on the original use pattern approved for USCs 13 and 14, while the Science Evaluation and tables in Appendix I of this Proposed Registration Decision PRD, Thiamethoxam, Actara 25WG Insecticide, Actara SC Insecticide, and other related end-use products, provide detailed technical information on the human health, environmental and value assessments of thiamethoxam and the end-use products Actara 25WG Insecticide and Actara SC Insecticide.
For more details on the information presented in this summary, please refer to the Science Evaluation of this PRD Validity period of conditional registrations In order to complete the consultations, the validity periods of the products listed in Table 1 have been extended until 31 December This extension was granted under 14 7 of the former Pest Control Products Regulations, to carry out the consultation on the proposed registration decisions with respect to these products.
The key objective of the Pest Control Products Act is to prevent unacceptable risks to people and the environment from the use of pest control products. Health or environmental risk is considered acceptable if there is reasonable certainty that no harm to human health, future generations or the environment will result from use or exposure to the product under its proposed conditions.
The Pest Control Products Act also requires that products have value when used according to the label directions. Conditions of registration may include special precautionary measures on the product label to further reduce risk. When special review or re-evaluation decisions affect the registration of a product, the effective date of the amendment or cancellation may also be delayed as long as there is no suitable alternative and the risk is acceptable during that time period.
To reach its decisions, the PMRA applies modern, rigorous risk-assessment methods and policies. These methods consider the unique characteristics of sensitive subpopulations in humans for example, children as well as organisms in the environment. These methods and policies also consider the nature of the effects observed and the uncertainties when predicting the impact of pesticides. For more information on how the PMRA regulates pesticides, the assessment process and risk-reduction programs, please visit the Pesticides section of Canada.
What Is Thiamethoxam? Actara SC Insecticide is applied using in-furrow application equipment on potatoes. Actara 25WG Insecticide is applied using foliar application equipment on pome fruits.
Thiamethoxam moves through the leaf surface and the translocation system of the plant, affecting the insects through contact and ingestion. Actara SC Insecticide and Actara 25WG Insecticide, containing thiamethoxam, are unlikely to affect your health when used according to label directions.
Potential exposure to thiamethoxam may occur through the diet food and water or when handling and applying the products. When assessing health risks, two key factors are considered: the levels where no health effects occur and the levels to which people may be exposed.
The dose levels used to assess risks are established to protect the most sensitive human population for example, children and nursing mothers. As such, sex and gender are taken into account in the risk assessment. Only uses for which the exposure is well below levels that cause no effects in animal testing are considered acceptable for registration. Toxicology studies in laboratory animals describe potential health effects from varying levels of exposure to a chemical and identify the dose where no effects are observed.
The health effects noted in animals occur at doses more than times higher and often much higher than levels to which humans are normally exposed when using pesticide-containing products according to label directions.
In laboratory animals, the technical grade active ingredient thiamethoxam was moderately acutely toxic via the oral route and of low toxicity via the dermal and inhalation routes of exposure.
It was minimally irritating to eyes, non-irritating to skin, and it did not cause an allergic skin reaction. Actara SC Insecticide was of low acute toxicity via the oral and dermal routes of exposure. It was slightly acutely toxicity via the inhalation route. Actara SC Insecticide was non-irritating to eyes and slightly irritating to skin. It did not cause an allergic skin reaction. Actara 25WG Insecticide was of low acute toxicity via the oral, dermal, and inhalation routes of exposure. It was mildly irritating to eyes and slightly irritating to skin.
Actara 25WG Insecticide did not cause an allergic skin reaction. Health effects in animals given repeat doses of thiamethoxam over long periods of time included effects on the liver, kidneys, testes and nervous system. There was no evidence to suggest that thiamethoxam damaged genetic material, and it did not cause cancer in rats. Thiamethoxam did produce liver tumours in mice; however, the process of tumour formation is not expected to occur in humans due to differences in metabolism.
In animal reproductive toxicity tests, adverse effects on the sperm and testes of offspring were observed at dose levels that did not have health effects in the mother, indicating that the young were more sensitive to thiamethoxam than the adult animal.
In additional studies in which pregnant animals were given thiamethoxam, reduced brain weight and changes in brain measurements were observed in offspring at dose levels which produced minimal effects on the mother, again suggesting sensitivity of the young. The risk assessment protects against the effects of thiamethoxam by ensuring that the level of human exposure is well below the lowest dose at which these effects occurred in animal tests.
Residues in Water and Food Dietary risks from food and water are not of concern. Based on these estimates, the intermediate chronic dietary risk from thiamethoxam is not of health concern for all population subgroups. The Food and Drugs Act prohibits the sale of adulterated food, that is, food containing a pesticide residue that exceeds the established maximum residue limit MRL. Food containing a pesticide residue that does not exceed the established MRL does not pose an unacceptable health risk.
Residue trials conducted throughout Canada using end-use products containing thiamethoxam on pome fruits and potatoes were sufficient to propose MRLs for pome fruits and potatoes. Risks in Residential and Other Non-Occupational Environments Non-occupational risks are not of concern provided that directions specified on the labels are observed. Occupational Risks From Handling Thiamethoxam Occupational risks are not of concern when thiamethoxam is used according to the proposed label directions, which include protective measures.
Farmers and pesticide applicators mixing, loading or applying either Actara SC Insecticide or Actara 25WG Insecticide as well as field workers re-entering treated fields can come in direct contact with thiamethoxam on the skin or through inhalation of spray mists. For this reason, the Actara SC Insecticide label specifies that anyone mixing or loading must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and boots and that anyone applying the product must wear coveralls and boots.
In the case of Actara 25WG Insecticide, the label specifies that anyone mixing and loading must wear a long-sleeved shirt, long pants, chemical resistant gloves, socks and boots and that anyone applying must wear a long-sleeved shirt, long pants, socks and boots.
Taking these label statements into consideration, precautionary measures, and the exposure duration, risks to farmers, applicators or postapplication workers are not a concern. For bystanders, exposure is expected to be much less than that for workers and is considered negligible.
Therefore, health risks to bystanders are not of concern. The risks to pollinators and aquatic invertebrates from outdoor uses of thiamethoxam have not been shown to be acceptable. As such, mitigation, including cancellation of some uses, has been proposed.
Thiamethoxam may enter the environment when applied by foliar spray or soil application to potatoes and pome fruit trees to control insect pests, as described in the original use pattern document ERC Thiamethoxam can come in contact with soil when it is applied directly on the ground, or sprayed on foliage and it washes off onto the ground, or comes into contact with the ground when sprayed on crops. The length of time that thiamethoxam will persist in soil depends on various factors including soil type.
In certain fields, thiamethoxam may persist long enough to carry over from one growing season to the next. Major products formed from the microbial degradation of thiamethoxam in soil are CGA clothianidin; also a registered pesticide and CGA , both of which can persist in soil. Thiamethoxam may enter the aquatic environment through spray drift or run-off. In water, thiamethoxam is expected to dissipate relatively quickly if exposed to sunlight. In the absence of sunlight, thiamethoxam will be broken down more slowly by microbes.
As such, thiamethoxam is moderately persistent in aquatic systems. CGA also dissipates relatively quickly if exposed to sunlight, but is moderately persistent in water in the absence of sunlight. Thiamethoxam and its soil transformation product CGA clothianidin can also leach through the soil into groundwater. The toxicity of thiamethoxam and its major transformation products to terrestrial and aquatic organisms can be found in ERC and PSRD Overall, there are risks to pollinators, other beneficial arthropods and aquatic invertebrates.
Actara 25WG Insecticide controls a variety of insect pests of potato, apple, crabapple, pear and oriental pear, Actara SC Insecticide controls insect pests of potato.
Actara SC Insecticide is an in-furrow treatment to control Colorado potato beetle, aphids and potato leafhopper on potato. Actara 25WG Insecticide is applied as a foliar spray and controls these same pests on potato, as well as plum curculio, mullein bug, spotted tentiform leafminer and rosy apple aphid on apple and crab apple, and plum curculio and pear psylla on pear and oriental pear.
These insects are important pests of their respective crops. These products have acceptable value. Measures to Minimize Risk Labels of registered pesticide products include specific instructions for use. Directions include risk-reduction measures to protect human and environmental health. These directions must be followed by law.
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