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Re-evaluation Decision RVD2011-11, Dodemorph-Acetate

Pest Management Regulatory Agency
13 December 2011
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2011-11E-PDF (PDF version)

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Table of Contents

Re-evaluation Decision for Dodemorph-Acetate

After completing the full re-evaluation of the fungicide dodemorph-acetate, Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the Next link will take you to another Web site Pest Control Products Act (PCPA) and Next link will take you to another Web site Regulations is granting continued registration of products containing dodemorph-acetate for certain uses in Canada.

An evaluation of available scientific information found that, under the revised conditions of use, products containing dodemorph-acetate for mini potted roses have value in ornamental industry and do not pose unacceptable risks to human health or the environment. All other uses of dodemorph-acetate, including greenhouse- and field-grown cut flower roses, are being phased out because they pose an unacceptable risk to human health, and therefore do not meet Health Canada's current standards for human health. As a condition of the continued registration for the mini potted rose use, new risk-reduction measures must be included on the labels. In addition, under Next link will take you to another Web site section 12 of the PCPA, the registrant is required to submit additional scientific information.

The regulatory approach regarding the re-evaluation of dodemorph-acetate was first proposed in the consultation document1 Proposed Re-evaluation Decision PRVD2009-10, Dodemorph-Acetate. This Re-evaluation Decision2 describes this stage of the PMRA's regulatory process concerning the re-evaluation of dodemorph-acetate and summarizes the Agency's decision and the reasons for it.

Comments received during the consultation period were taken into consideration. These resulted in a change in the regulatory decision that was proposed in PRVD2009-10. Appendix I summarizes the comments received during the consultation period and provides the PMRA's response to these comments. Appendix II describes data requirements. Appendix III outlines the revised label statements.

What Does Health Canada Consider When Making a Re-evaluation Decision?

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 conditions or proposed conditions of registration.3 The Act also requires that products have value4 when used according to the label directions. Conditions of registration may include special precautionary measures on the product label to further reduce risk.

To reach its decisions, the PMRA applies hazard and risk assessment methods as well as policies that are rigorous and modern. These methods consider the unique characteristics of sensitive subpopulations in both humans (for example, children) and organisms in the environment (for example, those most sensitive to environmental contaminants). These methods and policies also consider the nature of the effects observed and the uncertainties present 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 and Pest Management portion of Health Canada's website at healthcanada.gc.ca/pmra.

What is Dodemorph-Acetate?

Dodemorph-acetate is a systemic fungicide belonging to the Resistance Management Mode of Action (MOA) Group Number 5 (amines). It is used to control powdery mildew on greenhouse- and field-grown roses. It is only available as a Commercial Class product and is applied solely by ground application equipment.

Health Considerations

Can Approved Uses of Dodemorph-Acetate Affect Human Health?

Risks to human health via dietary or applicator/mixer/loader exposure are not of concern; however, postapplication exposure is of concern for cut flower roses. The phase out of use on greenhouse and field cut flower roses is to be implemented to mitigate risk concerns. Postapplication risks are not of concern for field and greenhouse mini potted roses. Dodemorph-acetate is allowed for continued registration on mini potted roses provided that risk-reduction measures are added to the label and inhalation exposure data requirements are met.

Potential exposure to dodemorph-acetate may occur through the diet (drinking water), when handling and applying the product, or when entering treated areas. When assessing health risks, two key factors are considered: the levels at which no health effects occur in animal testing 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). 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 100-times higher (and often much higher) than levels to which humans are normally exposed when dodemorph-acetate products are used according to label directions.

Dodemorph-acetate is of low oral toxicity to rats and low dermal toxicity to rabbits. The requirement for an acute inhalation toxicity study has been waived due to the inability of the active ingredient to be adequately aerosolized for test purposes and due to the anticipated irritative properties of the compound. Dodemorph-acetate is extremely irritating to the skin, severely irritating to the eye and is a potential skin sensitizer. Consequently, the following warning statements should appear on the label of the technical product: "Poison, Danger: Skin Irritant and Corrosive to the Eyes, Potential Skin Sensitizer."

The target organ of dodemorph-acetate is the liver, with effects including increases in liver weights and various histopathological findings of the liver being observed at doses at or above doses causing body weight effects and/or vomiting in test animals.

There was no evidence that dodemorph-acetate was genotoxic or evidence of carcinogenicity in mice or in male rats. A slight increase in rare ovarian adenocarcinomas was observed in female rats exposed to high doses of dodemorph-acetate for two years.

When dodemorph-acetate was given to pregnant rats, a shortened gestation period was observed in the dams, with delays in pup development, increases in prenatal mortality, as well as foetal malformations. Due to the nature of these endpoints and their potential pre- and post- natal implications, extra protective measures were applied during the risk assessment to further reduce the allowable level of human exposure to dodemorph-acetate.

The risk assessment protects against these effects 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 water are not of concern.

As dodemorph-acetate is not registered for use on food commodities the dietary risk assessment considered exposure from drinking water only.

Reference doses define levels to which an individual can be exposed over a single day (acute) or lifetime (chronic) and expect no adverse health effects. Generally, dietary exposure from food and water is acceptable if it is less than 100% of the acute reference dose or chronic reference dose (acceptable daily intake). An acceptable daily intake is an estimate of the level of daily exposure to a pesticide residue that, over a lifetime, is believed to have no significant harmful effects.

One-day (acute) and long term (chronic) drinking water exposure estimates were determined for the general population and different sub-population groups representing different ages, genders and reproductive status. A conservative (i.e. upper bound estimates) approach was used to estimate dodemorph-acetate residues in water.

The acute and chronic exposure estimates from water were below the level of concern for all population groups.

Risks in Residential and Other Non-Occupational Environments

Non-occupational risks are not of concern.

As there are no registered residential uses of dodemorph-acetate, exposure and risk to people in and around residential areas is expected to be negligible.

Occupational Risks from Handling Dodemorph-Acetate

Occupational risks are not of concern for mixer/loaders/applicators.

Risk estimates associated with mixing, loading and application activities are acceptable and additional personal protective equipment are not required beyond what is currently specified on the label.

Postapplication risks to workers are of concern.

Postapplication risk estimates associated with re-entry activities for field and greenhouse cut flower roses are of concern. Risk concerns could not be adequately addressed with the use of restricted entry intervals (REIs) or limiting the number of applications on the label; thus phase out of the use on cut flower roses is to be implemented to mitigate risk concerns.

Information was provided to the PMRA during the comment period of the Proposed Re-evaluation Decision (PRVD) which indicates that the morphology and use pattern for mini potted roses is different than cut flower roses. This would warrant different inputs for the postapplication exposure assessment for the two categories of roses. The PMRA agrees with these comments and has conducted a separate postapplication risk assessment for mini potted roses.

Postapplication risks were not of concern for mini potted roses following a single application, a spray volume of 700 L/ha, and exposure from the dermal route alone. Postapplication indoor inhalation exposure could not be assessed due to a lack of data and is a major uncertainty in the assessment. Comments were received which indicates that postapplication indoor inhalation exposure is likely minimal due to greenhouse ventilation and residue particle size; however, this assumption needs to be confirmed with indoor air monitoring data. Thus, dodemorph-acetate will be allowed for use on mini potted roses provided that inhalation exposure data requirements are met and the label be revised to specify one application per crop cycle and a maximum spray volume of 700 L/ha. A minimum 12 hour restricted-entry interval (REI) is also required on the label.

Environmental Considerations

What Happens When Dodemorph-Acetate Is Introduced Into the Environment?

Dodemorph-acetate poses a potential risk to certain terrestrial and aquatic organisms, and therefore, additional risk reduction measures need to be observed.

Although it is primarily used in greenhouses, there is potential environmental exposure from application of dodemorph-acetate to mini potted roses grown in the field as well as runoff from application in some types of greenhouse structures.

Dodemorph-acetate is a not a persistent substance in the soil and water. Phototransformation is rapid in both media and is the dominant mode of transformation in soils, except under acidic conditions. Biotransformation is the dominant mode of transformation in the water column and sediment.

Dodemorph-acetate was not found to be a risk to bees or earthworms. However, it does pose a potential risk to beneficial arthropods. Both birds and mammals were found to be at risk if they consume food sources sprayed with dodemorph-acetate. However, birds were not found to be at risk from consuming food sources present off-field that was contaminated with spray drift, although mammals were found to be at risk. However, given the mobile nature of mammals, and hence, their reduced exposure, the risk from spray drift of dodemorph-acetate is not expected to be a concern for mammals or birds. Dodemorph-acetate is not a risk to most aquatic organisms, from runoff or spray drift with the exception of amphibians from spray drift. The risk to amphibians can be mitigated through the use of spray buffer zones. Additional risk reduction measures such as buffer zones and advisory/precautionary label statements need to be observed.

Value Considerations

What is the Value of Dodemorph-Acetate?

Dodemorph-acetate provides good control of powdery mildew on greenhouse- and field-grown roses.

Powdery mildew caused by Sphaerotheca pannosa damages the upper surface of the leaves of new shoots of roses with buds. The disease must be well controlled before cosmetic damage makes the rose crop unfit for sale. Rose growers use dodemorph-acetate 5-7 weeks before harvest in rotation with other fungicides for the control of powdery mildew. Dodemorph-acetate has both protective and curative modes of action, is systemic, and has been identified as having a low to medium risk for resistance development. It is an important tool to Canadian rose growers for the control of powdery mildew particularly under high disease pressure, and also for resistance management since it can be used in rotation with other active ingredients registered for the same use. In Canada, it is estimated that a total of about 153 hectares of roses are grown (greenhouse: 23 hectares and outdoor: 130 hectares). Total rose production value is estimated at $110 million at retail.

Powdery mildew on roses is very aggressive and is listed on the U.S.-Canada Grower Priority Database as a priority for this crop. In the absence of suitable alternatives, under high disease pressure, the industry may be unable to satisfactorily control the disease. Some growers may not be able to market their crop and could suffer heavy losses.

Other alternative active ingredients to dodemorph-acetate are currently registered for the control of powdery mildew on greenhouse- and field-grown roses. These include thiophanate-methyl, propiconazole, myclobutanil, triforine, trifloxistrobin, copper, sulphur, folpet, potassium bicarbonate and a biofungicide, Bacillus subtilis. Limitations to the available alternatives are as follows:

  • Some are currently under re-evaluation;
  • The number of applications per crop cycle is limited; and
  • Cross resistance against powdery mildew has been reported in other active ingredients within other MOA groups.

Measures to Minimize Risk

Labels of the registered pesticide product include specific instructions for use. Directions include risk-reduction measures to protect human and environmental health. These directions must be followed by law.

Risk-reduction measures are being implemented to address potential risks identified in this assessment. These measures, in addition to those already identified on existing dodemorph-acetate product labels, are designed to further protect human health and the environment. Registrants will be asked to amend their labels to reflect these additional measures. The additional key risk-reduction measures that will be required are as follows:

Additional Key Risk-Reduction Measures:

Human Health

  • Statement specifying that dodemorph-acetate is allowed for use on field and greenhouse mini potted roses only.
  • A statement indicating that one application is allowed per crop cycle.
  • A statement indicating that a maximum spray volume of 700 L/ha is allowed.
  • A restricted-entry interval of 12 hours to protect workers entering treated sites.

Environment

To reduce the release of dodemorph-acetate into the environment for the protection of terrestrial and aquatic habitats that may contain sensitive species, the PMRA is proposing:

Additional advisory statements to protect non-target species Buffer zones for aquatic habitats

What Additional Scientific Information is Being Requested?

Air monitoring data to quantitatively assess inhalation exposure of postapplication workers to dodemorph-acetate in the greenhouse are required. These data have been requested from the registrant and are required under section 12 of the Pest Control Products Act. The registrant of this active ingredient must provide these data (Appendix II) or an acceptable scientific rationale to the PMRA within the time line specified in the decision letter.

Other Information

The relevant test data on which the decision is based (as are available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa)). For more information, please contact the PMRA's Pest Management Information Service by phone (1-800-267-6315) or by e-mail (pmra.infoserv@hc-sc.gc.ca).

Any person may file a notice of objection5 regarding this decision on dodemorph-acetate 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, www.hc-sc.gc.ca/cps-spc/pest/part/protect-proteger/publi-regist/index-eng.php#rrd), or contact the PMRA's Pest Management Information Service.

Appendix I - Comments and Responses

1.0 Comments Pertaining to the Health Risk Assessment

In response to PRVD2009-10, comments relating to the health risk assessment were received from the Next link will take you to another Web site British Columbia Ministry of Agriculture and Lands, Next link will take you to another Web site Flowers Canada Growers, Next link will take you to another Web site BASF Canada, and Next link will take you to another Web site Ontario Ministry of Agriculture, Food and Rural Affairs (OMAFRA). Some comments have been grouped by content instead of stakeholders as there were comments relating to the same topic from different stakeholders.

1.1 The registrant commented on three key areas of the toxicology hazard assessment which they claim to be a "number of overlapping conservative assumptions" that led to conclusions reached by the PMRA.

  1. The registrant suggests the use of oral studies to conduct occupational risk assessments overestimates the toxicity by the dermal and inhalation routes of exposure.

    Response:

    In the 2009 PRVD, the PMRA had selected the rabbit developmental toxicity study for use in the short- and intermediate-term dermal and inhalation risk assessments. In the rabbit developmental toxicity study, malformations and embryo-foetal loss were observed at dose levels that did not cause maternal toxicity. Currently, there are no studies available from the dermal or inhalation route of exposure investigating the developmental toxicity of dodemorph-acetate. As the worker population could include pregnant women, it is necessary to ensure adequate protection of the foetus who may be exposed via their mother. After consideration of the registrant's comments, it was concluded that the approach taken for the dodemorph-acetate risk assessment was appropriate and consistent with recent evaluations conducted by the PMRA.

  2. The registrant suggested that the selection of the "conservative endpoint" from the rabbit developmental toxicity study in the short- and intermediate- term occupational risk assessments would provide sufficient protection for workers and that an additional 10-fold factor would not be required.

    Response:

    As discussed above, the rabbit developmental toxicity was selected for use in the risk assessment to protect the foetus of pregnant workers.

    In June of 2006, the new PCPA came into force and required that the PMRA apply an additional 10-fold margin of safety to account for pre- and post-natal toxicity and completeness of the data with respect to the exposure of and toxicity to infants and children. A considerable amount of stakeholder feedback was received and taken into consideration when developing Science Policy Note SPN2008-01, The Application of Uncertainty Factors and the Pest Control Products Act Factor in the Human Health Risk Assessment of Pesticides.

    In accordance with SPN2008-01 and consistent with recent risk assessments in which serious concerns have been raised for the health of the unborn child, the PMRA considers it appropriate to maintain the PCPA factor at 10-fold for the short- and intermediate-term occupational risk assessments of dodemorph-acetate.

  3. The registrant contested the addition of a 3-fold uncertainty factor to account for lack of an established NOAEL in the 1 year dog toxicity study.

    Response:

    In the 2009 PRVD, the one year dog toxicity study was selected for use in the dietary (chronic) and long-term occupational risk assessments. The established LOAEL in the dog study was based upon vomiting and decreased body weight gain; effects which had also been observed in the 28- and 90-day dog toxicity studies. The PMRA has revisited its 2009 assessment and maintains that the observed effects in the 1-year dog study are both treatment-related and adverse. However, due to the predisposition of canines to vomiting and the transient nature of the effects on body weight gain, it was determined that the LOAEL marked the threshold of toxicity for the animals. Therefore, an uncertainty factor of 1-fold for lack of an established NOAEL was considered more appropriate for use with the 1-year dog toxicity study. As a result of this amendment, reference doses and toxicology endpoints were revised as follows:

Table 1 - Revised Toxicology Endpoints
RfD (mg/kg bw or mg/kg bw/day) Study NOAEL (or LOAEL) CAF or Target MOE and Rationale1

ARD/ADI,
Females 13-49

0.04

NOAEL: 40 mg/kg bw/day

Rabbit Developmental Toxicity
(post-implantation loss, cleft palate, open eye, septal defects, missing lumbar vertebrae)

1000 -fold factor

including a 10-fold PCPA factor due to concerns for the unborn child (as outlined in the discussion on the application of the PCPA factor)

ARD
General Population

0.4

NOAEL: 40 mg/kg bw/day

28- and 90-Day Dog Studies
(post-dosing salivation, vomiting)

100

including a 1-fold PCPA factor

ADI
General Population

0.1

LOAEL: 10 mg/kg bw/day

1-Year Dog Study
(gastric irritation, body weight gain)

100

including a 1-fold
PCPA factor and a 1-fold factor for lack of an established NOAEL

Short-term
Intermediate-term
Long-term

Dermal2 and Inhalation3




Not Applicable

NOAEL: 40 mg/kg bw/day

Rabbit Developmental Toxicity
(post-implantation loss, cleft palate, open eye, septal defects, missing lumbar vertebrae)

1000

including a 10-fold factor due to concerns for the unborn child (as outlined in the discussion on the application of the PCPA factor)

1 CAF (Composite assessment factor) refers to the total of uncertainty and PCPA factors for dietary risk assessments, MOE refers to target MOE for occupational assessments
2 Since an oral NOAEL was selected, a dermal absorption factor of 54% is used in a route-to-route extrapolation.
3 Since an oral NOAEL was selected, an inhalation absorption factor of 100% (default value) is used in route-to-route extrapolation.

1.2 Comments related to Restricted-entry Intervals and Personal Protective Equipment of Postapplication Workers.

  • The BC Ministry of Agriculture and Lands suggests looking for other precautionary measures, including the use of gloves or an extended re-entry interval to reduce the postapplication exposure risk to workers.
  • The registrant BASF has conducted an independent postapplication exposure and risk assessment in response to the PRVD. A clothing penetration factor of 10% (i.e. reduction of dermal exposure by 90%) was proposed in the risk assessment to account for gloves worn by postapplication workers.

Response:

Re-entry intervals were calculated for postapplication workers in the field and ranged from 24-31 days; these were not considered to be agronomically feasible for cut flower roses and were not proposed as a mitigation option. For greenhouse postapplication workers, the REIs could not be calculated due to the lack of adequate data to determine the indoor dissipation rate.

The PMRA acknowledges that gloves are often worn during post-harvest activities for roses; however, the type of glove worn may not be chemical resistant and thus not reduce exposure. Chemical resistant gloves for postapplication workers cannot be proposed on labels and considered in the risk assessment as enforcement is not assured due to varying occupational health and safety legislation and/or policies pertaining to agricultural postapplication workers across Canada. Agricultural postapplication workers do not necessarily have access to the product label to inform themselves of the appropriate personal protective equipment. Since compliance of these label statements is not assured, the risk assessment conducted by the PMRA assumes that agricultural postapplication workers do not wear protective equipment.

1.3 Comments related to Dislodgeable Foliar Residue.

BASF proposes a dislodgeable foliar residue (DFR) value of 0.315 μg/cm2 derived from two exposure studies conducted by Brouwer, et al., submitted on 22 September 2009. The proposed DFR value is lower than the DFR of 3.84 μg/cm2 (Max.) used by the PMRA. BASF questioned why this study was not considered by the PMRA.

Response:

The two documents cited above report results from the same study for dodemorph-acetate. The study includes measurement of dermal exposure in workers as well as measurement of DFR in roses. The PMRA had evaluated the study and deemed it unacceptable for quantitative use. The study did not follow guidelines acceptable to PMRA for the conduct of postapplication exposure studies (USEPA Office of Chemical Safety and Pollution and Prevention Harmonized Test Guidelines-Series 875, Occupational and Residential Exposure Test Guidelines). A summary evaluation of the DFR study is provided below.

In the study, a total of 13 greenhouses were examined with dodemorph-acetate being applied with either a high-volume spray gun or low-volume mister. The mean application rate was 2.62▒1.50 kg ai/ha. Dermal exposure rate of 2 workers per greenhouse was measured during cutting, sorting and bundling using (pre-washed) cotton gloves which covered the hands and forearms. Measurements were performed for the whole period of cutting, sorting, and bundling in the treated crop. The average re-entry interval for workers was 23 hours and the average work time was 70 minutes. The mean dermal exposure rate was 1.8 ▒ 1.7 mg ai/h, 1.9 ▒ 2.3 mg ai/h, and 1.9 ▒ 2.2 mg ai/h for cutting, sorting, and bundling, respectively. The major limitation of this study was lack of adequate quality control (i.e. no data on % field recovery, no controls reported and no details on storage conditions). In addition, several other major limitations were identified including high variation between replicates, the use of residue data from the hands and forearms to calculate whole body dermal exposure, and inadequate reporting of results and methodology. Due to these limitations, the dermal exposure data was not used quantitatively for the postapplication exposure and risk assessment.

For the DFR portion of the study, dodemorph-acetate residues were analyzed on rose leaf samples just before application and after harvesting. The sampling time was not specified. BASF reported that sampling was considered at 17 hours after application; however, no data was available to validate this information. Nonetheless, in order to determine the dissipation, more than 1 sampling time is required. Two samples, consisting of eighteen leaves each, were taken from six adjacent flower beds in the middle of each greenhouse. The geometric mean DFR was determined to be 0.26 ▒ 1.8 µg/cm2 (~1% of application rate) and was calculated using one-sided leaf surface area. Several major limitations were identified in the DFR data including the lack of details on quality control (no data on % field recovery, no controls reported and no details on storage conditions), use of only 1 sampling time (time also not specified) to determine DFR, only using one side of the leaf to calculate surface area, high variation between replicates, and inadequate reporting of results and methodology. As adequate data was not available to determine the DFR, the default value of 20% of the application rate was used to estimate the peak DFR (day 0 after application) in greenhouse and field roses. For subsequent days after application, the outdoor dissipation rate of 10%/day was used to calculate the DFR on field roses. However, due to differences in environmental conditions (humidity, temperature, rainfall, ultraviolet light, etc), the outdoor dissipation rate is not considered to be appropriate for use to estimate DFR dissipation in greenhouses. As there is no default dissipation rate for indoor settings, only day 0 postapplication exposure could be assessed for greenhouse roses.

1.4 Comments Related to Dermal Absorption

  • BASF proposes a dermal penetration value of 20% instead of the PMRA value of 54%. The proposed BASF value is based on an in vitro dermal absorption study on file. BASF questioned why the PMRA did not consider this study.

Response:

The PMRA has reviewed the in vitro dermal absorption study during the comment period. The study was not available for use in the original assessment reported in the PRVD2009-10 as it was submitted late in the re-evaluation process. The 20% dermal penetration value proposed by BASF is based on the in vitro human skin data for the low dose treatment group.
Currently, the PMRA considers in vitro data as part of a triple pack approach with in vivodata.

As outlined in the 2008 NAFTA position paper on the use of in vitro dermal absorption data in risk assessment, when in vitrodata are being submitted, it is recommended that they be submitted as part of a triple pack of in vitro human and animal studies and an in vivo animal study. Under this triple pack approach, if an in vitro technique performed using animal skin is shown to be a good predictor of animal in vivo dermal absorption for a particular compound, then the same technique conducted in vitro with human skin may be useful in extrapolating to humans. In other words, when laboratory studies demonstrate that the ratio of the animal in vitro to in vivo dermal absorption factor is close to 1, a human in vitro study conducted under the same conditions as the animal test is likely to be a good predictor of human dermal absorption. The usefulness of the data would necessarily be dependent on the validity and applicability of the experimental design and the quality and integrity of the data. Consideration of the 'minimal standards' discussed in the position paper (such as same dose/duration regime), would also be required prior to acceptance of the triple pack approach.

The submitted in vitro study was considered along with the in vivo study (Wenker, PMRA#1210608) as part of a 'triple pack approach'. The rat in vitro study does not meet the minimum requirements for comparison to the rat in vivo study as the dose levels for the low dose group between the two studies are different (9 versus 31.7 µg/cm2) and the in vivo study used an occlusive covering over the treated rat skin while the in vitro study did not. The dose levels and occlusion are both factors that can effect dermal penetration, thus the dermal absorption values obtained from the two studies are not comparable. Refer to Table 2 for further details.

As the submitted in vitro dermal absorption studies did not meet the criteria for the 'triple pack approach' the dermal absorption value of 54% cannot be further refined at this time.

Table 2 - Summary Comparison of in vitro and in vivo Dermal Absorption Studies for Dodemorph-Acetate
Site Dose (µg/cm2) Vehicle Exposure Time (h) Study Length (h) % Absorbed
Rat in vivo*
Back 9 Blank Formulation 6 96 33
54 (corrected)
4400 19
43 (corrected)
Rat in vitro
Dorsal flank 31.7 Blank Formulation 6 24 32
42 (+ tape strips)
3075 7.1
7.9 (+ tape strips)
Human in vitro
Abdomen 31.7 Blank Formulation 6 24 11
20**
28 (+ tape strips)
3075 1.6
4.0 (+ tape strips)

* Parafilm covering was used over the skin to mimic occlusion.
** % absorbed + tapes strips, omitting the 1st and 2nd tape strip. Value used by BASF and assuming the residues on the top layer of skin won't be absorbed.

1.5 Comments Related to Number of Application per Crop Cycle.

  • The Ontario Ministry of Agriculture, Food, and Rural Affairs indicate that typically three applications of dodemorph-acetate are used per crop.
  • BASF has proposed an alternate approach for calculating exposure for a multiple application scenario, assuming a 10 day application interval, with 25 applications per year and a dissipation rate of 3.4% (based on foliar residue half life of 20 days). This results in a multiple application factor (MAF) of 3.41 or a 3.41 fold increase in postapplication worker exposure as compared to a single application use scenario.

Response:

One application was assumed in the postapplication exposure and risk assessment. A multiple application scenario was not assessed as risk concerns were identified after only one application.

The approach used by BASF to determine the MAF and estimate postapplication exposure is not consistent with the standard regulatory procedures to estimate exposure as outlined in Series 875 - Occupational and Residential Exposure Test Guidelines. Nonetheless, even using BASFs exposure estimates with multiple applications, target MOEs were not reached and risk continues to be of concern. Thus, a multiple application scenario cannot be supported.

The PMRA considers dislodgeable foliar residue and dissipation rate data to be major uncertainties in the current postapplication exposure and risk assessment. Additional data such as a guideline DFR study would need to be generated in order to support a multiple application use pattern.

1.6 Comments Relating to Transfer Coefficient, Work Hours and Postapplication Inhalation Exposure.

  • Flowers Canada has provided production outlines for greenhouse cut roses and mini rosesand a table which presents typical work scenarios and exposure of workers to pesticides. It was indicated that typical fungicides are sprayed 5-7 weeks before harvest to control powdery mildew and applied 3 to 5 times per crop cycle. Meltatox (the end-use product containing dodemorph-acetate) is used as one of the rotational fungicides. The risk to workers producing mini roses is lower because there is usually no application of the fungicide during the vegetative stage. In addition, workers wear PPE or use mechanical techniques while cutting and/or harvesting. Air concentration and inhalation risk (after the REI) are considered low because hydraulic high volume sprayers equipment are unlikely to leave droplets (100-400 microns) dispersed in the air. For low volume or fogger sprayers, standard greenhouse ventilation practices are applied. Mixer, loader, applicator and worker wear PPE while handling. A typical greenhouse workday is 7-9hours; however, not all the time is contacting with the sprayed crops. The default transfer coefficient (TC) values of 7000 cm2/h should be reduced to 4000 and 400 cm2/h for cut flowers and potted plants, respectively. The residues of pesticides in greenhouse flowers dissipate over time and should be reconsidered.
  • In the BASF postapplication exposure and risk assessment, eight hours of daily work time was used in the calculation; however, it was indicated that six hours is the more realistic according to Flowers Canada. A TC of 4550 cm2/h was used based on study data from Brouwer, et al. (PMRA# 1662768 and PMRA# 1662770).
  • The Ontario Ministry of Agriculture, Food, and Rural Affairs indicates that exposure of workers to dodemorph-acetate may be over estimated. Field-grown roses are not handled very often during their production cycle. Typical worker activities in field-grown rose production occur in the first year only of the three-year production. Direct worker exposure during activities in potted rose production is not often.

Response:

A transfer coefficient of 4000 cm2/h was used for cut flower roses in the postapplication exposure and risk assessment and an 8 hour work day was assumed. These assumptions are consistent with the PMRAs current standard operating procedure for assessing postapplication worker exposure. Inhalation exposure and risk for postapplication workers was not assessed due to the lack of data. Furthermore, as there were risk concerns identified from dermal exposure alone, any further exposure via inhalation would further contribute to the risk.

In the absence of specific data, the general comments from Flowers Canada regarding work hours and dissipation were considered qualitatively. In general, due to the very low MOEs achieved at one application, compared to a target MOE of 1000, lower work hours and multiple applications even with some dissipation would still result in risks of concern. Overall, there are inadequate data to assess inhalation exposure, dissipation rate, and multiple application exposure scenarios.

The PMRA agrees that due to the specific cultural practice and plant morphology, mini potted roses can be assessed separately from cut flower roses. Further, the TC for mini potted plants is 400 cm2/h. This exposure scenario was not considered in the original assessment as the dodemorph-acetate label indicated use for field and greenhouse roses, and not mini potted roses specifically. The PMRA has also obtained additional spray volume information from Flowers Canada for mini potted roses, which are lower compared to cut flower roses; 600-700 L/ha for mini potted roses versus 1000-2000 L/ha for cut flower roses. Thus the rate for mini potted roses is lower than for cut flower roses.

The postapplication worker risk assessment for the mini potted rose assessment is presented in Table 2. The target MOE is achieved on day 0 of application from exposure via the dermal route for a single application scenario. However, inhalation exposure still needs to be assessed. Comments were received that indicated postapplication inhalation exposure would be minimal due to greenhouse ventilation and residue particle size; however, this assumption needs to be confirmed with indoor air monitoring data in order to estimate inhalation exposure.

Table 3 - Revised Dodemorph-Acetate Postapplication Work Risk Assessment
Use Site TC (cm2/h) Rate (kg ai/ha) Peak DFR1 (µg ai/cm2) Dermal MOE2 on Day 0 REI (days)
Short-Intermediate-Long Term Target MOE = 1000 2
Cut Flower Roses - field and greenhouse 4000 0.96 (low)3 1.92 84 244
1.92 (high)3 3.84 42 314
Mini potted Roses - field and greenhouse 400 0.675 1.34 1206 12 hrs

TC = transfer coefficient, DFR = dislodgeable foliar residue, MOE = margin of exposure, REI = restricted entry interval
1 Peak DFR = 20% of the rate.
2 Short-Intermediate-Long Term Dermal Endpoint (based on oral study) = 40 mg/kg bw/day, with a target MOE of 1000.
Dermal MOE = Short-Intermediate-Long Term Dermal Endpoint ÷ Dermal Exposure
Dermal Exposure = TC × Peak DFR × Work Hours (8 hrs) × Dermal Absorption (54%) ÷ Body Weight (70 kg) ÷ Unit Conversion (1000 µg/mg)
3 Rate for cut flower roses based on spray volume (SV) of 1000-2000 L/ha and label rate of 0.96 g/L, which = 0.96-1.92 kg/ha. The SV information for cut flower roses was provided by BASF.
4 REI only applicable to cut flower field roses assuming a default dissipation of 10%/day, these REIs are not considered agronomically feasible. REIs could not be calculated for cut flower greenhouse roses due to the lack of data to assess indoor dissipation.
5 Rate for mini potted roses based on SV of 700 L/ha and label rate of 0.96 g/L, which = 0.67 kg/ha. The SV information was provided by Flowers Canada.

2.0 Comments Pertaining to Value

In response to PRVD2009-10, comments relating to the value of dodemorph-acetate were received from various stakeholders. The response to value comments has been combined as the comments received addressed similar topics.

2.1 Comments pertaining to value and limitations to alternatives.

The BC Ministry of Agriculture and Lands emphasized that dodemorph-acetate is an important fungicide for the management of powdery mildew on field-grown and greenhouse-grown roses. It is most commonly reserved to treat serious outbreaks of powdery mildew because of its excellent efficacy and higher product cost. The loss of dodemorph-acetate would take away one of the most effective products and the lone Group 5 fungicide registered for powdery mildew.

Flowers Canada growers support dodemorph-acetate remaining registered until a time when there are viable additional alternatives available. There are limitations to the current alternatives. Dodemorph-acetate is an economically important fungicide for the management of powdery mildew on roses.

The Canadian Nursery Landscape Association emphasized that dodemorph-acetate is an important pest management tool for outdoor nursery growers in Canada. Because of its unique mode of action, growers typically use it as a rotational tool for resistance management and under circumstances of high disease pressure. The Association encourages continued and responsible use of dodemorph-acetate until suitable alternatives are available.

The Ontario Ministry of Agriculture, Food and Rural Affairs (OMAFRA) advises dodemorph-acetate is an important fungicide for the control of powdery mildew in field-grown and greenhouse-grown roses. The disadvantages of some registered alternative pest control products are 1) the labels for the alternatives tend to be limiting; and 2) these products are not as efficacious especially under high disease pressure. Therefore, the loss of dodemorph-acetate will have an impact on growers' ability to manage this disease. OMAFRA encourages a graduated, measured response to re-evaluation registration decisions, taking into account the impact they may have on pest management in commodity specific situations.

Response:

The PMRA acknowledges that dodemorph-acetate is an important fungicide for the control of powdery mildew on roses particularly under high disease pressure situations. The PMRA also agrees that although there are some registered alternative active ingredients to dodemorph-acetate for this use, as listed in Appendix IV of PRVD 2009-10, most of them are not as efficacious as dodemorph-acetate under high disease pressure or are limited regarding the number of applications per crop cycle. Furthermore, dodemorph-acetate is the only systemic fungicide from Group 5 with both protective and curative modes of action registered for control of powdery mildew on roses which makes it an important tool for resistance management when used in rotation with other fungicides. All available alternatives are currently under re-evaluation except for a microbial biofungicide, QST 713 strain of Bacillus subtilis (suppression only), trifloxistrobin and a reduced-risk chemical, potassium bicarbonate (suppression only).

Appendix II - Data Requirements for Dodemorph-Acetate

The following data are required under section 12 of the Pest Control Products Act.

The registrant is required to provide additional data to determine dodemorph-acetate air concentration in the greenhouse after application.

DACO 5.10 - Ambient Air Samples

Sampling which measures the amount of pesticide in a given volume of ambient air. Ambient air samples are collected to estimate inhalation exposure, where such exposure may occur, or to establish appropriate re-entry intervals for indoor studies. Breathing zone samples are preferable for estimating inhalation exposure. Refer to the OPPTS Test Guideline Series 875 - Occupational and Residential Exposure Test Guidelines: Group B- Postapplication Monitoring Guidelines (formerly Subdivision K) for guidance on conducting air sampling.

Appendix III - Label Amendments for Products Containing Dodemorph-Acetate

The label amendments presented below do not include all label requirements for individual 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 products in Canada must be amended to include the following statements to further protect workers and the environment.

Technical Class Product:

The following warning statement should appear on the primary panel of the technical product labels:

Danger Poison, Corrosive to Eyes and Skin, Potential Skin Sensitizer

Commercial Class Product:

Use on mini potted roses:

Directions for use

The following statements must be included:
Greenhouse grown mini potted roses:

The product can be used on mini potted rose varieties only. Apply at the rate of 2.5 mL per litre of water (2.5 L in 1000 L) at a maximum spray volume of 700 L/ha. Do not apply more than once per crop cycle. To prevent possible plant damage under hot and sunny conditions, the humidity in the greenhouse should be increased several hours prior to application.

Field grown mini potted roses:

Use the same directions as listed under greenhouse mini potted roses.

Precautions

The following statements must be included:

Do not enter or allow workers entry into treated areas for 12 hours following application to all crops.
Add to ENVIRONMENTAL HAZARDS

  • TOXIC to aquatic organisms. Observe buffer zones specified under DIRECTIONS FOR USE.
  • TOXIC to birds and small wild mammals.
  • TOXIC to beneficial insects. It is recommended that this product not be used in areas where beneficial insects are used in IPM. Minimize spray drift to reduce harmful effects on beneficial insects in habitats next to the application site such as hedgerows and woodland.

Run Off

  • To reduce runoff from treated areas into aquatic habitats, avoid application to areas with a moderate to steep slope, compacted soil or clay.
  • Avoid application when heavy rain is forecast.
  • Contamination of aquatic areas as a result of runoff may be reduced by including a vegetative strip between the treated area and the edge of the water body.

Volatilization

  • To minimize the release of dodemorph-acetate into the environment due to volatilization, Dodemorph-acetate should only be applied on cool mornings and evenings when air temperatures are 15°C or lower.

Add to DIRECTIONS FOR USE

General Restrictions

  • DO NOT apply this product directly to freshwater habitats (such as lakes, rivers, sloughs, ponds, prairie potholes, creeks, marshes, streams, reservoirs, ditches and wetlands), estuaries or marine habitats.
  • DO NOT contaminate irrigation/drinking water supplies or aquatic habitats by cleaning of equipment or disposal of wastes.
  • DO NOT allow effluent or runoff from greenhouses containing this product to enter lakes, streams, ponds or other waters.

Buffer Zones:

Field sprayer application: DO NOT apply during periods of dead calm. Avoid application of this product when winds are gusty. DO NOT apply with spray droplets smaller than the American Society of Agricultural Engineers (ASAE) fine classification. Boom height must be 60 cm or less above the crop or ground.

DO NOT apply by air.

Buffer zones:

Use of the following spray methods or equipment DO NOT require a buffer zone: hand-held or backpack sprayer and inter-row hooded sprayer.

The buffer zones specified in the table below are required between the point of direct application and the closest downwind edge of sensitive freshwater habitats (such as lakes, rivers, sloughs, ponds, prairie potholes, creeks, marshes, streams, reservoirs and wetlands).

Buffer Zones Required For the Protection of Aquatic Life For Dodemorph-Acetate
Method of application Crop Buffer Zones (metres) Required for the Protection of:
Freshwater Habitat of Depths:
Less than 1 m Greater than 1 m
Field sprayer* Roses 3 m 0

* For field sprayer application, buffer zones can be reduced with the use of drift reducing spray shields. When using a spray boom fitted with a full shield (shroud, curtain) that extends to the crop canopy, the labelled buffer zone can be reduced by 70%. When using a spray boom where individual nozzles are fitted with cone-shaped shields that are no more than 30 cm above the crop canopy, the labelled buffer zone can be reduced by 30%.

References

A. List of Studies/Information Submitted by Registrant

Toxicology
PMRA Document Number Reference
1319053 2003, BAS 238 F (Dodemorph-Acetate): Physical Characteristics, P-49-01-0, DACO: 2.14.1, 2.14.2, 2.14.3, 2.14.4, 2.14.5, 2.14.6 CBI
1319058 1999, Spectra of Dodemorph-Acetate (Reg.-N. 22341), DACO: 2.14.12 CBI
1319064 1991, Aqueous Solubility Determination of Dodemorph-Acetate at pH 5 and pH 9, HWI 6293-109, DACO: 2.14.7 CBI
1319065 2003, BAS 238 F (Dodemorph-Acetate): Solubility in Organic Solvents, DACO: 2.14.8 CBI
1319066 1989, Vapor Pressure Determination of Dodemorph-Acetate, DACO: 2.14.9 CBI
1319054 2003, BAS 238 F (Dodemorph-Acetate): Dissociation Constant (pKa), DACO: 2.14.10 CBI
1319057 1991, Octanol/Water Partition Coefficient Determination of Dodemorph-Acetate at pH 5 and pH 9, DACO: 2.14.11 CBI
1319043 1992, Dodemorph-Acetate: Description of the Manufacturing Process, DACO: 2.11.3 CBI
1319052 1992, Preliminary Analysis of Dodemorph-Acetate Technical by Analytical Methods CP 142/1 and CP 143/1, DACO: 2.13.3 CBI
1210564 1992, Acute Oral Toxicity Study in Rats, DACO: 4.2.1
1210567 1992, Acute Dermal Toxicity Study in Rabbits - Limit Test, DACO: 4.2.2
1210569 1988, Report on the Acute Toxicology Testing of Dodemorph-Acetate (Technical Grade), DACO: 4.2.4
1606165 2003, BAS 238F (Dodemorph-Acetate) - 90 day toxicity study in rats with administration by the diet, incorporating a neurotoxicity screen, DACO: 4.3.1
1210562 1971, Report on the 28-day Test of Feeding Rats with Cyclododecyl-2,6-dimethylmorphol acetate (=Dodemorph). DACO: 4.3.3
1210565 1969, Concerning the Subacute Dermal Tolerance of Cyclododecyl-2,6-dimethylmorpholinium Acetate (Abbreviated : CDA) in NZW Rabbits, DACO: 4.3.5
1210566 1969, Concerning the Subacute Dermal Tolorance of Cyclododecyl-2,6-dimethylmorpholinium Acetate (Abbreviated : CDA) in NZW Rabbits - Historical Investigations, DACO: 4.3.5
1210568 2003, Dodemorph-Acetate (BAS 238F) - Acute Inhalation Toxicity Study in Rats, DACO: 4.2.3
1210570 2002, Acute Dermal Irritation Test of BAS 238 F (Dodemorph-Acetate) in Rabbits, DACO: 4.2.5
1210571 2001, Assessment of Contact Hypersensitivity to Dodemorph-Acetate in the Albino Guinea Pig ( Maximisation - Test ), DACO: 4.2.6
1210575 1977, Oral Toxicity of Dodemorph-Acetate, 100% - Call for Short "Dodemorph" in Beagle Dogs, DACO: 4.3.8
1210576 1977, Oral Toxicity of Dodemorph-Acetate (N-Cyclododecyl-2,6-dimethyl-morpholine acetate), Assay 100% - Called For Short "Dodemorph" - in the Beagle Dog, DACO: 4.3.2
1210577 2002, One Year Oral (Capsule) Chronic Toxicity of BAS 238 F (Dodemorph-Acetate) in Dogs (OEDC May 1981, 452; U.S. EPA 712-C-96-210 June 1996, OPPTS 870.4100)., DACO: 4.3.2
1210578 2003, One Year Oral (Capsule) Chronic Toxicity of BAS 238 F (Dodemorph-Acetate) in Beagle Dogs (OEDC May 1981, 452; U.S. EPA 712-C-96-210 June 1996, OPPTS 870.4100)., DACO: 4.3.2
1210579 2001, Reg. No. 022341- Prenatal Development Toxicity Study in Wistar Rats - Oral Administration (Gavage), DACO: 4.5.2
1210580 1992, Preliminary information: One-Generation Reproduction Toxicity Study of Reg No. 22 341 in Rats - Dietary Administration ( Range-Finding Study)., DACO: 4.5.1
1210581 1992, Preliminary Information: Maternal Toxicity Study of Reg. No.22341 in Rabbits After Oral Administration (By Gavage) (Range Finding Study)., DACO: 4.5.1
1210582 1994, Study of the Prenatal Toxicity of Reg. No. 22341 in Himalayan Rabbits After Oral Administration (Gavage), DACO: 4.5.3
1210583 1994, Reproduction Toxicity Study With Reg. No. 22341 in Wistar Rats - Continuous Dietary Administration Over 2 Generations ( 2 Litters in the First and 1 Litter in the Second Generation), DACO: 4.5.1
1210584 1977, Test for Mutagenicity in Bacterial Stains in the Absence and Presence of a Liver Preparation, DACO: 4.5.4
1210586 1985, Report on the Salmonella/Microsomal Assay (AMES-Test) for Bacterial Mutagenic Activity of Dodemorph-Acetate, DACO: 4.5.4
1210587 1985, Report of the DNA-Repair Assay for Determining the DNA-Modifying Activity of Dodemorph-Acetate, DACO: 4.5.8
1210588 1985, Report on the Cytogenetic Investigations in NMRI Mice After a Single Oral Administration of Reg. No. 22 341 - Micronucleus Test, DACO: 4.5.7
1210589 1986, Report on a Point Mutation Test Carried Out on CHO Cells (HGPRT Locus) With the Test Substance Dodemorph-Acetate, DACO: 4.5.5
1210590 1985, Report on the In Vitro Cytogenetics Study; Chromosomal Aberrations in Chinese Hamster Ovary (CHO) Cells of Dodemorph-Acetate, DACO: 4.5.6
1210591 Report on the evaluation of Dodemorph-Acetate in the In Vitro Rat Primary Hepatocyte Unscheduled DNA Synthesis Assay, DACO: 4.5.8
1210592 2003, Absorption, Distribution, Metabolism and Excretion of Single and Repeated Oral Doses of 14C-Dodemorph-Acetate in the Wistar Rat (OECD 417), DACO: 4.5.9
1448461 2004, BAS 238 F (Dodemorph-acetate): An eighteen Month Oral (dietary) Carcinogenicity Study in Mice, DACO: 4.4.3
1448463 2004, BAS 238 F (Dodemorph-acetate): A two year oral (dietary) combined Chronic toxicity/carcinogenicity Study in Rats, DACO: 4.4.4
Occupational
PMRA Document Number Reference
1190291 1987, Study to Establish Degradation Profiles For Six Pesticides (Triforine, Endosulfan, Chlorothalonil, Sulfotep, Dodemorph-Acetate and Daminozide) used on Ornamental Foliage in San Diego County California During Fall 1986. DACO: 5.9
1210607 1992, Interim Report on the Study to Determine Application Exposure to Milban Fungicide (Dodemorph-Acetate) Greenhouse Long-Stem Rose Cultivation. DACO: 5.4
1210608 2003, Dermal Absorption Study With 14C-Dodemorph-Acetate in the Wistar Rat. DACO: 5.8
1662936 2006, In vitro percutaneous absorption of dodemorph-acetate in BAS 239 14F through human and rate skin memebranes sing flow-through diffusion cells, DACO: 5.8
1876943 2010, Dodemorph, Worker postapplication dermal exposure Refined Risk Assessment, DACO: 5.14
Environment
PMRA Document Number Reference
1319063 1989, Water Solubility Determination of Dodemorph-Acetate, DACO: 2.14.7 CBI
1319064 1991, Aqueous Solubility Determination of Dodemorph-Acetate at pH 5 and pH 9, DACO: 2.14.7 CBI
1319066 1989, Vapor Pressure Determination of Dodemorph-Acetate, DACO: 2.14.9 CBI
1319054 2003, BAS 238 F (Dodemorph-Acetate): Dissociation Constant (pKa), DACO: 2.14.10 CBI
1319055 2003, BAS 238 F (Dodemorph-Acetate): n-Octanol/Water Partition Coefficient, DACO: 2.14.11 CBI
1319056 1989, Octanol/Water Partition Coefficient Determination of Dodemorph-Acetate, DACO: 2.14.11 CBI
1319057 1991, Octanol/Water Partition Coefficient Determination of Dodemorph-Acetate at pH 5 and pH 9, DACO: 2.14.11 CBI
1319058 1999, Spectra of Dodemorph-Acetate (Reg.-N. 22341), DACO: 2.14.12 CBI
1319071 1991, Henrys Law Constant Calculations for Dodemorph-Acetate (Supplementary Report), DACO: 2.16 CBI
1210609 2001, Validation of an Analytical Method for the Determination of Dodemorph-Residues in Soil, DACO: 8.2.2.1
1210610 2001, Validation of an Analytical Method for the Determination of Dodemorph Residues in Water, DACO: 8.2.2.1
1210611 2003, Validation of an Analytical Method for the Determination of BAS 238F ( Dodemorph-Acetate) in Soil, DACO: 8.2.2.1
1210612 2003, BAS 238 F (Dodemorph-Acetate) - Hydrolysis., DACO: 8.2.3.2
1210613 1989, Hydrolysis of 14C-Dodemorph-Acetate in Buffered Aqueous Solution, DACO: 8.2.3.2
1210614 1991, Artificial Sunlight Photodegradation of 14C-Dodemorph-Acetate on Soil, DACO: 8.2.3.3.1
1210615 1991, Artificial Sunlight Photodegradation of 14C-Dodemorph-Acetate in Buffered Aqueous Solutions, DACO: 8.2.3.3.2
1210616 2003, Aerobic Rate of Soil Degradation of BAS 238 F (Dodemorph-Acetate), DACO: 8.2.3.4.2
1210617 1998, Determination of the Degradation Rate of Dodemorph in Two Soils, DACO: 8.2.3.4.2
1210618 1991, Aerobic and Aerobic/Anaerobic Soil Metabolism of 14C-Dodemorph-Acetate, DACO: 8.2.3.4.4
1319238 1998, Degradation of Dodemorph in Aerobic Aquatic Environment, DACO: 8.2.3.5.2
1319239 1987, Report on Aquatic Biodegradation of Dodemorph, DACO: 8.2.3.5.2
1582583 1998, Degradation of Dodemorph in aerobic aquatic environment, DACO: 8.2.3.5.6
1319240 1998, Aged Leaching of Dodemorph, DACO: 8.2.4.2
1319241 1989, The Adsorption and Desorption of 14C-Dodemorph-Acetate on Representative Agricultural Soils, DACO: 8.2.4.2
1319242 1979, Determination of the Constants of the Adsorption Isotherm of Dodemorph-Acetate in the System Soil/Water, DACO: 8.2.4.2
1319243 1974, Leaching Behaviour of the Fungicidally Active Ingredient, DACO: 8.2.4.4
1319244 2003, Volatilization of Dodemorph-Acetate Formulated as EC-Formulation from Soil under Laboratory Conditions, DACO: 8.2.4.5
1319245 2003, Determination of Dodemorph-Acetate in Samples from a Volatilization Study with BAS 238 08 F, DACO: 8.2.4.5
1319246 2003, Determination of the Concentration of BAS 238 F (Dodemorph-Acetate) in Air - Validation of the Method, DACO: 8.6
1319305 1998, Acute Toxicity Study in the Earthworm with Dodemorph-Acetate, DACO: 9.2.3.1
1319306 1991, Effect of BAS 238 07 F on the Mortality of the Earthworm, Eisenia Fetida, DACO: 9.2.3.1
1448464 2003, BAS 238 07F (dodemorph-acetate): Reproduction toxicity to the earthworm Eisenia andrei., DACO: 9.2.3.1
1319307 1999, Laboratory Testing for Toxicity (Acute Contact and Oral LD 50) of Dodemorph-Acetate on Honey Bees (Apis Mellifera L.) (Hymenoptera, Apidae), DACO: 9.2.4.1
1326156 2003, BAS 238 07 F: Acute Toxicity to the Honeybee Apis mellifera L. under Laboratory Conditions. Final Report (2nd original of 2)., DACO: 9.2.4.1
1326157 2003, BAS 238 07 F: Acute Dose-Response Toxicity to the Predatory Mite Typhlodromus pyri (Scheuten) under Laboratory Conditions. Final Report (2nd original of 2)., DACO: 9.2.5
1326158 2003, BAS 238 07 F: Acute Dose-Response Toxicity to the Cereal Aphid Parasitoid Aphidius rhopalosiphi (DeStefani-Perez) under Laboratory Conditions. Final Report (2nd original of 2)., DACO: 9.2.6
1319308 1981, Determination of the Acute Toxicity of Dodemorph (BAS 238-F, Techn.Wirkstoff), DACO: 9.3.2
1319309 1999, Acute Toxicity Study in Daphnia Magna with Dodemorph-Acetate (Static), DACO: 9.3.2
1326159 2003, A Study on the Daphnia Acute Toxicity of BAS 238 07 F, DACO: 9.3.2
1582584 1999, Daphnia magna, reproduction test with dodemorph-acetate (semi-static), DACO: 9.3.3
1319310 1999, 96-Hour Acute Toxicity Study in Rainbow Trout with Dodemorph-Acetate (Static), DACO: 9.5.2.1
1326160 2003, A Study on the Freshwater Fish (Rainbow Trout) Acute Toxicity of BAS 238 07 F, DACO: 9.5.2.1
1326161 1974, The Acute Oral Toxicity (LD50) of Mehltaumittel to the Mallard Duck, DACO: 9.6.2.2
1326162 1974, The Acute Oral Toxicity (LD50) of Mehltaumittel to the Japanese Quail, DACO: 9.6.2.3
1582585 1974, The acute oral toxicity (LD50) of mehltaumittel to the Japanese Quail, DACO: 9.6.2.4,9.6.2.5,9.6.3.1
1582586 1974, The acute oral toxicity (LD50) of mehltaumittel to the Mallard Duck, DACO: 9.6.2.4,9.6.2.5,9.6.3.1
1582587 2006, Appendix 11 - Risk of dodemorph to fish via birds - Revised version, DACO: 9.6.2.4,9.6.2.5,9.6.3.1
1319310 1999, 96-Hour Acute Toxicity Study in Rainbow Trout with Dodemorph-Acetate (Static), DACO: 9.5.2.1
1319311 1999, Fresh Water Algal Growth Inhibition Test with Dodemorph-Acetate, DACO: 9.8.2
1326163 2003, A Study on the Toxicity of BAS 238 07 F to Algae (Pseudokirchneriella subcapitata), DACO: 9.8.2

B. Additional Information Considered

PACR 2004-10. Re-evaluation of Sulphur. Pest Management Regulatory Agency, Ottawa, Ontario. (http://www.hc-sc.gc.ca/cps-spc/pest/part/consultations/_pacr2004-10/index-eng.php).

Published Information
PMRA Document Number Reference
1662768 Brouwer, R., Marquart, H., Mik, G.D., and van Hemmen, J.J. 1992. Risk Assessment of Dermal Exposure of Greenhouse Workers to Pesticides after Re-Entry. Arch. Environ. Contam. Toxicol. 23: 273-280, DACO: 5.10,5.8,5.9(A)
1678034 Reffstrup, T.K., Østergaard, G., Haas, U., and Meyer, O. 2001. European Chemicals Bureau: Evaluation of the reproductive toxicity of fenpropimorph and proposal for classification (http://ecb.jrc.it/classlab/7195a99_DK_fenpropimorph.doc), classification., DACO: 12.5.4
1662943 van Hemmen J.J., Brouwer, R., Brouwer, D.H. 1992, Worker Exposure to pesticides in Greenhouses Health Risks during Harvesting of Flowers, DACO: 5.10, 5.8, 5.9(A)
European Commission. 2008. Dodemorph Final Addendum to the Draft Assessment Report (DAR) -Public Version.
U.S. EPA Office of Chemical Safety and Pollution and Prevention (OCSPP). 1996. Series 875 - Occupational and Residential Exposure Test Guidelines.
Unpublished Information
PMRA Document Number Reference
1558906 PMRA Review Report. Submission #2003-0561, DACO: 5.8
1558907 PMRA Review Report. Submission #2003-0561, DACO: 5.9
1611551 RUAS Dodemorph-Acetate Uses Table DER- Revised. Submission #2003-0561.
1618500 Dodemorph-Acetate Water Assessment. Submission #2003-0561.
1619923 BASF Canada. Email from BASF to the PMRA. 1st May, 2008. DACO: 0.8
1612979 Toxicology Re-evaluation of Dodemorph-Acetate. Submission #2003-0561.
2091603 Watson, G. 2011. Comment on PRVD2009-10 Dodemorph-acetate. DACO: 10.6
NAFTA. 2008. Draft NAFTA Dermal Absorption Group Position Paper On Use of In Vitro Dermal Absorption Data in Risk Assessment. Unpublished


1Return "Consultation statement" as required by subsection 28(2) of the Pest Control Products Act.

2Return "Decision statement" as required by subsection 28(5) of the Pest Control Products Act.

3Return "Acceptable risks" as defined by subsection 2(2) of the Pest Control Products Act.

4Return "Value" as defined by subsection 2(1) of the Pest Control Products Act: "the product's actual or potential contribution to pest management, taking into account its conditions or proposed conditions of registration, and includes the product's (a) efficacy; (b) effect on host organisms in connection with which it is intended to be used; and (c) health, safety and environmental benefits and social and economic impact".

5Return As per subsection 35(1) of the Pest Control Products Act.