Re-evaluation Decision RVD2016-04, Imazamox
Pest Management Regulatory Agency
29 April 2016
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2016-4E-PDF (PDF version)
Table of Contents
Imazamox is a selective post-emergence herbicide, used for the control of broadleaf and grassy weeds in crops with imidazlinone tolerance in the Prairie provinces, Peace River region of British Columbia and Eastern Canada. There are 15 products containing imazamox that are currently registered in Canada under the authority of the Pest Control Products Act, including 1 technical grade active ingredient and 11 commercial class end-use products and 3 manufacturing concentrates.
It is approved for use in several Clearfield crops, soybean peas, dry edible beans (tank mix only), fenugreek for seed and forage uses, seedling and established alfalfa grown for seed, and bird's foot trefoil for seed production.
After a re-evaluation of imazamox, Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act, is granting continued registration of products containing imazamox for sale and use in Canada. An evaluation of available scientific information found that products containing imazamox do not present unacceptable risks to human health or the environment when used according to the conditions of registration, which include amended label directions. Label amendments are required for all end-use products as summarized below and listed in Appendix II. No additional data are requested at this time.
- Restricted-entry interval.
- Precautionary label statement to minimize bystander exposure from spray drift.
- Buffer zone and label statements to protect non-target terrestrial plants.
- Environmental hazard label statements
The PMRA's pesticide re-evaluation program considers potential risks, as well as value, of pesticide products to ensure they meet modern standards established to protect human health and the environment. Regulatory Directive DIR2012-02, Re-evaluation Program Cyclical Re-evaluation, presents the details of the cyclical re-evaluation approach, which is in line with the requirements of the Pest Control Products Act.
This re-evaluation decisionFootnote 1 was proposed in the consultation document, Proposed Re-evaluation Decision PRVD2015-04, Imazamox. One comment was received during the consultation process. Appendix I summarizes the comment received during the consultation process and the PMRA's response to this comment. This decision is consistent with the proposed re-evaluation decision stated in PRVD2015-04. A reference list for all data used as the basis for the re-evaluation decision is also included in PRVD2015-04.
To comply with this decision, the required mitigation measures must be implemented on all products labels sold by registrants no later than 24 months after the publication date of this decision document.
Any person may file a notice of objectionFootnote 2 regarding this decision on imazamox within 60 days from the date of publication of this Re-evaluation Decision. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides and Pest Management portion of Health Canada's website (Request a Reconsideration of Decision) or contact the PMRA's Pest Management Information Service.
Appendix I Comments and Responses
In response to the consultation document PRVD2015-04, Imazamox, comments related to the health assessment were received from the registrant.
Comment- No Observed Effect Level (NOEL)
The registrant requested clarification as to the source of the cited NOEL of 870 mg/kg bw/day. In the two year rat feeding study, no treatment-related effects were noted at doses up to 20,000 ppm which corresponds to an average daily intake of 1068 mg/kg bw/day in males and 1284 mg/kg bw/day in females.
With respect to the 2 year rat feeding study cited above, PMRA identified an error in the unit conversion from ppm to mg/kg bw/day. The correct NOEL values are 1068 mg/kg bw/day in males and 1284 mg/kg-bw/day in females. Following the revision of these values, the PMRA also determined that the chronic dietary exposure endpoint should be based on the no observed adverse effect level (NOAEL) of 900 mg/kg bw/day from the developmental toxicity study in rabbit, with support from the 2 year rat feeding study. Given the chronic dietary exposure to imazamox from food plus water for all subpopulations represented less than 10% of the acceptable daily intake (ADI) (based on the previous value of 8.7 mg/kg bw/day), the revised endpoint of 9.0 mg/kg bw/day does not significantly change the risk assessment outcome. Therefore, the proposed re-evaluation decision stated in PRVD 2015-04 remains unchanged. The revised endpoints are summarized in Table 1.
|Study||UF/SF or MOETable 1 footnote 1|
|Chronic Dietary||NOAELTable 1 footnote 2 = 900||Developmental rabbit study, supported by 2 year rat oral (dietary) study; based on a slightly reduced mean maternal body weight gain during the dosing and post-dosing periods at the highest dose tested (900 mg/kg bw/day) and no effects observed up to and including the highest dose tested in rats (1068/1284 mg/kg bw/day male/female)||100|
|ADITable 1 footnote 3 = 9.0 mg/kg bw/day, UF = 100|
|Short- and intermediate-term dermal||NOELTable 1 footnote 4 = 1000||28-day rat dermal study, no effects observed up to and including the highest dose tested (1000 mg/kg bw/day)||100|
|Short- and intermediate-term inhalationTable 1 footnote 5||NOAEL= 900||Developmental toxicity study in the rabbit; based on a slightly reduced mean maternal body weight gain during the dosing and post-dosing periods at the highest dose tested (900 mg/kg bw/day)||100|
Appendix II Label Amendments for Products Containing Imazamox
The label amendments presented below do not include all label requirements for individual end-use products, such as first aid statements, disposal statements, precautionary statements and supplementary protective equipment. Information on labels of currently registered products should not be removed unless it contradicts the label statements provided below.
"Field sprayer application: DO NOT
- Under PRECAUTIONS, the following statements must be added:
- The following statements must be included in a section entitled ENVIRONMENTAL HAZARDS.
- The following statements must be included in a section entitled DIRECTIONS FOR USE.
|Method of Application||Crop||Buffer Zones (Metres) Required for the Protection of Terrestrial Habitat|
|Field sprayer||Alfalfa, bird's foot trefoil, Brassica juncea, canola, dry bean, field pea, lentil, soybeans, sunflower and wheat||1|
Appendix III Registered Imazamox Products as of 8 March 2016
|25109||Technical||BASF Canada Inc.||IMAZAMOX TECHNICAL HERBICIDE||Solid||IMZ: 97%|
|29027||Manufacturing Concentrate||BASF Canada Inc.||RAPTOR 1AS BULK||Solution||IMZ: 120 g/L|
|30506||Manufacturing Concentrate||BASF Canada Inc.||ARES BULK HERBICIDE||Solution||IMZ: 33 g/L
ARS: 15 g/L
|31422||Manufacturing Concentrate||BASF Canada Inc.||VIPER ADV BULK||Solution||BZN: 429 g a.e./L
IMZ: 20 g/L
|25110||Commercial||BASF Canada Inc.||AC 299,263 70 WDG||Water Dispersible Granules||IMZ: 70% a.e.|
|25111||Commercial||BASF Canada Inc.||ODYSSEY WDG HERBICIDE||Water Dispersible Granules||IMZ: 35% a.e.
IMP: 35% a.e.
|25496||Commercial||BASF Canada Inc.||SOLO WDG HERBICIDE||Wettable Granule||IMZ: 70% a.e.|
|26705||Commercial||BASF Canada Inc.||AC 299,263 120 AS HERBICIDE SOLUTION||Solution||IMZ: 120 g/L (present as ammonium salt)|
|27879||Commercial||BASF Canada Inc.||ADRENALIN SC HERBICIDE||Emulsifiable Concentrate||IMZ: 20 g/L
DXF: 560 g a.e. /L
|28741||Commercial||BASF Canada Inc.||SOLO WDG HERBICIDE (CLEARFIELD CROPS)||Water Dispersible Granules||IMZ: 70% a.e.|
|30188||Commercial||BASF Canada Inc.||ARES||Solution||IMZ: 33 g/L
ARS: 15 g/L
|30626||Commercial||BASF Canada Inc.||VIPER ADV||Solution||BZN: 429 g a.e./L
IMZ: 20 g./L
|31353||Commercial||BASF Canada Inc.||ODYSSEY ULTRA A (A COMPONENT OF ODYSSEY ULTRA HERBICIDE TANK MIX)||Water Dispersible Granules||IMZ: 35% a.e.
IMP: 35% a.e.
|31504||Commercial||BASF Canada Inc.||Salute B Herbicide||Solution||IMZ:15 g/L|
|32066||Commercial||BASF Canada Inc.||Solo Adv||Solution||IMZ: 25 g/L|
IMZ - imazamox; ARS - imazapyr; IMP - imazethapyr; DXF - 2,4-D [(2,4-dichlorophenoxy)acetic acid]; BZN - bentazon
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