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Appendix 1: Impact Analysis Document

2004

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May 17, 2004

Hazard Class

Current Review

Changes required for GHS implementation

Hazard

Current Assessment


Symbols

Signal Words

Other

Potential Impact/Issues

Assessed

Communicated

Acute oral

-4 hazard categories

-3 signal words: Danger, Warning, Caution (Poison)

- skull & crossbones (S/CB) contained within 3 border shapes

-exposure levels are combined with hazard assessment to determine whether there are risks associated with the use of the product

-risk mitigation measures applied

-stan-
dardized border shape (◊)

-new symbol (!) for many domestic products to replace S/CB

loss of "Caution"

loss of "Poison"

Retain: "Danger",

"Warning"

- as the lowest toxicity category (LD50 2000-5000 mg/kg bw) will now carry "Warning" and hazard statement vs none, there may be an ↑ in numbers of submissions as registrants may wish to test out (i.e. LD50 ≥ 5000 mg/kg bw)
- eup: if registrants opt to use "formula" approach in lieu of submitting eup tox data, would be decrease in tox 6-packs but could increase workload for evaluators
- Market Class safety criteria: GHS cut-off value for oral toxicity category 4 is slightly lower than PMRA's current cut-off value for eligibility in the Domestic market class; some pesticides currently bearing a COMMERCIAL market class designation would be considered eligible for the DOMESTIC market class

Option 1: Adopt categories 1-4 only
- Maintains current practices

Option 2: Adopt all 5 categories
- Increase workload due to companies submitting data to "test out" (i.e. LD50 ≥ 5000 mg/kg bw) in order to negate hazard communication requirement

Regardless of Option:
- Labelling changes are required.
- Impact of market class cut-off realignment
- Potential increase in workload of "formula" approach option


Hazard Class

Current Review

Changes required for GHS implementation

Hazard

Current Assessment

Symbols

Signal Words

Other

Potential Impact/Issues

Assessed

Communicated

Acute dermal

 √

-4 hazard categories
-3 signal words: Danger, Warning, Caution (Poison)
- skull & crossbones (S/CB) contained within 3 border shapes

-exposure levels are combined with hazard assessment to determine whether there are risks associated with the use of the product
-risk mitigation measure applied 

-stan-
dardized border shape (◊)

- new symbol (!) for many domestic products to replace S/CB

loss of "Caution"

loss of "Poison"


Retain: "Danger",

"Warning"

 

- as the lowest toxicity category (Dermal LD50 2000-5000 mg/kg bw) will now carry "Warning" and hazard statement vs none, there may be an ↑ in number of submissions as registrants may wish to test out (i.e. LD50 ≥ 5000 mg/kg bw)
- eup: if registrants opt to use "formula" approach in lieu of submitting eup tox data, would be decrease in tox 6-packs but could increase workload for evaluators
- market class cut-off values may need to be changed to align with those of the GHS

Option 1: Adopt categories 1-4 only
- Maintains current practices

Option 2: Adopt all 5 categories
- Increase workload due to companies submitting data to "test out" (i.e. LD50 ≥ 5000 mg/kg bw) in order to negate hazard communication requirement

Regardless of Option:
- Labelling changes are required.
- Impact of market class cut-off realignment
- Potential increase in workload of "formula" approach option

Acute inhal-
ation

-4 hazard categories
-3 signal words: Danger, Warning, Caution (Poison)
- skull & crossbones (S/CB) contained within 3 border shapes

-exposure levels are combined with hazard assessment to determine whether there are risks associated with the use of the product
-risk mitigation measure applied

-stan-
dardized border shape (◊)

- new symbol (!) for many domestic products to replace S/CB

loss of "Caution"

loss of "Poison"


Retain: "Danger",

"Warning"

- as the lowest toxicity category (Inhalation LC50 ≥5 mg/L) will now carry "Warning" and hazard statement vs none; by default all products would require labelling (Warning, etc.) due to the technical difficulties of generating a test atmosphere at high enough concentrations OR there may be an ↑ # subs as reg'ts may wish to test out (i.e. LC50 ≥ 5 mg/L w/ no deaths)
- eup: if registrants opt to use "formula" approach in lieu of submitting eup tox data, would be decrease in tox 6-packs but could increase workload for evaluators
- market class cut-off values may need to be changed to align with those of the GHS
- should PMRA adopt the criteria for classification of gases or maintain status quo? (i.e. due to toxic nature and restricted use, would always require PPE)

Option 1: Adopt categories 1-4 only
- Cut-Off values differ from current practices
-Increased workload due to companies submitting data to "test out" OR test to a limit dose with no deaths in order to negate hazard communication requirement

Option 2: Adopt all 5 categories
- All products labelled

Regardless of Option:
- Labelling changes are required.
- Impact of market class cut-off realignment
- Potential increase in workload of "formula" approach option