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Re-evaluation Note REV2011-02, Acrolein

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18 February 2011
ISSN: 1925-0630 (print version)
ISSN: 1925-0649 (PDF version)
Catalogue number: H113-5/2011-2E (print version)
Catalogue number: H113-5/2011-2E-PDF (PDF version)

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Regulatory Strategy

Acrolein is one of the active ingredients under re-evaluation by Health Canada's Pest Management Regulatory Agency (PMRA). The purpose of this Re-evaluation Note is to notify registrants, pesticide regulatory officials and the Canadian public of interim mitigation measures to be implemented for pesticide products containing acrolein. The measures include amendments to the labels of acrolein products, and to the Application and Safety Manual of the restricted class product registered for the control of submerged and floating weeds and algae in irrigation canals (product registration number 10948) to further protect workers, bystanders and the environment. Additional data are required to conduct a refined environmental exposure and risk assessment for acrolein.

The regulatory approach for the re-evaluation of acrolein was first presented in Re-evaluation Note REV2010-11, Acrolein, a consultation document.¹

No comments were received during the consultation process. This Re-evaluation Note describes this stage of PMRA's regulatory process. The required mitigation measures and data are consistent with the proposal stated in REV2010-11. Interim label amendments are outlined in Appendix I. Appendix II lists data requirements. To comply with this decision, registrants of products containing acrolein will be informed of the specific requirements affecting their product registration(s).

The implementation of these measures is considered to be a first step towards the completion of the re-evaluation of the Canadian uses of products containing this active ingredient.

Other Information

Any person may file a notice of objection² regarding this decision on Acrolein 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 - Interim Label Amendments for Products Containing Acrolein

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 below.

The labels of end-use products in Canada must be amended to include the following statements to further protect workers and the environment.

Magnacide B Microbiocide, Registration Number. 27928

The label of the commercial class product registered for use in oilfield injection systems (Registration Number 27928) must be amended as follows to further protect workers, bystanders and the environment.

1. In the "DIRECTION FOR USE" section, the following statement must be removed:
   
   
   This material must only be applied in accordance with directions on this label and under the direct supervision of trained personnel.
   
   and replaced with the following:
   
   
   This material must only be applied in accordance with directions on this label. Applicators must have completed a training program on the safe use of this product provided by the registrant within the last 12 months.

Magnacide H Herbicide, Registration Number 10948

A. Amendments to the Product Label

The label of the restricted product registered for the control of submerged and floating weeds and algae in irrigation canals (Registration Number 10948) must be amended to include the following statements to further protect workers, bystanders and the environment.

1. The following statement must be included on the primary display panel:
   
   This product must be accompanied by the product Application and Safety Manual. Read and understand the entire label and manual prior to use. All parts of the product label and manual are important for safe and effective use of this product and must be implemented during application.
   
   
2. The following statements must be included in the boxed section "NOTICE TO USER":
   
   
   During application, two trained and certified applicators must be on site at all times. Applicators must be able to maintain visual contact with all applicators participating in the application. No-one is allowed to participate in the application unless they are holding an appropriate pesticide applicator certificate or license recognized by the provincial/territorial pesticide regulatory agency where the pesticide application is to occur and applicators must complete a training program provided by the registrant within the last 12 months. The registrant training program must comprise, at the minimum, training on the safe and effective use of this product including all parts of this label and the MAGNACIDE H Herbicide Application and Safety Manual.
   
   All applications must be made during daylight hours.
   
   Do not exceed 8 applications per application point per year. An individual application point, as defined, may consist of multiple treatments/releases within a contiguous irrigation canal, to ensure aquatic weed control throughout the entire irrigation canal or portion thereof.
   
   A minimum of 14 days between applications must be respected.
   
   Applicators must placard or post signs at the start and end of each canal section, and around the perimeter of the application equipment area. Specific sign requirements are listed in the product Application and Safety Manual under DIRECTIONS FOR USE.
   
   
   
3. The following statement must be removed from the section entitled "ENVIRONMENTAL HAZARDS":
   
   
   This product is toxic to fish and wildlife.
   
   and replaced by:
   
   
   This product is toxic to aquatic organisms, birds, and mammals.
   
   
4. The following statement must be removed from the section titled "TOXICOLOGICAL INFORMATION - WARNING SIGNS AND SYMPTOMS":
   
   
   Because of the extreme lachrymatory warning effect, the concentration tolerable by man is far below the minimum lethal concentration.

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B. Amendments to the Application and Safety Manual

The product Application and Safety Manual must be amended to include a module on reducing wildlife exposure. This module is to focus on:

• the risks to fish and aquatic organisms;
• the importance of limiting the contamination of natural fish bearing waters by release of acrolein treated canal water; and
• how to contain the irrigation water while acrolein is degrading.

This module must be submitted to the PMRA for approval prior to its inclusion in the product Application and Safety Manual.

The Application and Safety Manual of the restricted product registered for the control of submerged and floating weeds and algae in irrigation canals (Registration Number 10948) must also be amended to include the following statements to further protect workers, bystanders and the environment.

1. The following statements must be included in the boxed section "NOTICE TO USER":
   
   
   During application, two trained and certified applicators must be on site at all times. Applicators must be able to maintain visual contact with all applicators participating in the application. No-one is allowed to participate in the application unless they are holding an appropriate pesticide applicator certificate or license recognized by the provincial/territorial pesticide regulatory agency where the pesticide application it to occur and applicators must complete a training program provided by the registrant within the last 12 months. The registrant training program must comprise, at the minimum, training on the safe and effective use of this product including all parts of the product label and this Application and Safety Manual.
   
   All applications must be made during daylight hours.
   
   Do not exceed 8 applications per application point per year. An individual application point, as defined, may consist of multiple treatments/releases within a contiguous irrigation canal, to ensure aquatic weed control throughout the entire irrigation canal or portion thereof.
   
   A minimum of 14 days between applications must be respected.
   
   Applicators must placard or post signs at the start and end of each canal section, and around the perimeter of the application equipment area. Specific sign requirements are listed under DIRECTIONS FOR USE.
   
   
2. The following statements must be included in the section entitled "DIRECTIONS FOR USE":

   Applicators must placard or post signs at the start and end of each canal section, and around the perimeter of the application equipment area (truck, hoses and skids). Signs posted around the application equipment area must be no more than 4.5 metres apart. All signs must conform to the following requirements:

   1. Signs shall be at least 35 cm by 25 cm in size, and letters at least 7 cm in height, unless smaller-sized signs are necessary because the treated area is too small to accommodate signs of this size. Letters shall be clearly legible.
   2. Signs must bear the following:
      1. The signal word "DANGER" and the skull and crossbones.
      2. The statements "DO NOT ENTER", "Pesticide Application in Progress" and "NO SWIMMING"
      3. The start date and time of application.
      4. The end date and time of application.
      5. The name of the pesticide.
      6. The name, address and telephone number of the applicator or pesticide handler.

   Signs must remain posted during application and must be removed no later than 3 days after treatment. Only a certified applicator (or someone under his/her supervision) may remove warning signs.

   Handlers must use a closed system that is designed by the manufacturer to prevent dermal and inhalation exposures by removing the product from the container and applying the product below the water's surface. At any disconnect point, the system must be equipped with a dry disconnect or dry couple shut-off device that will limit drippage to no more than 2 ml per disconnect. The closed system must function properly and be used and maintained in accordance with the manufacturer's written operating instructions. Handlers must wear the personal protective equipment on this labelling.

3. The following statement must be removed from the section entitled "ENVIRONMENTAL HAZARDS":

   This product is toxic to fish and wildlife.

   and replaced by:

   This product is toxic to aquatic organisms, birds, and mammals.

4. The following statement must be removed from the section entitled "FIRST AID - Toxicological Information - WARNING SIGNS AND SYMPTOMS":

   Because of the extreme lachrymatory warning effect, the concentration tolerable by man is far below the minimum lethal concentration.

Appendix II - Additional Data Requirements

The following data are required as a condition of continued registration under section 12 of the  Pest Control Product Act. The registrants of acrolein are required to provide these data or an acceptable scientific rationale within 24 months from the date of the decision letter that will be sent by the PMRA.

• DACO 8.2.3.3.3 - Phototransformation - air
• DACO 8.2.3.4.2 - Biotransformation in soil - aerobic soil 20-30°C
• DACO 8.2.3.4.4 - Biotransformation in soil - anaerobic (flooded) soil 20-30°C
• DACO 8.2.3.5.2 - Biotransformation in aquatic systems - aerobic water 20-30°C
• DACO 8.2.3.5.5 - Biotransformation in aquatic systems - anaerobic sediment/water 20-30°C
• DACO 8.2.4.2 - Laboratory studies of mobility - adsorption / desorption
• DACO 9.8.4 - Terrestrial vascular plants

These studies must be conducted with MAGNACIDE H Herbicide (Registration Number 10948) or a product with equivalent formulation and guarantee and be conducted according to the appropriate  USEPA Office of Prevention, Pesticides and Toxic Substances or Organisation for Economic Co-operation and Development guidelines.