PMRA Re-evaluation Update · Consulting and developing a policy for stakeholder engagement and...
Transcript of PMRA Re-evaluation Update · Consulting and developing a policy for stakeholder engagement and...
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PMRA Re-evaluation Update Canadian Horticultural Council Meeting
March 10, 2016
Margherita Conti
Value Assessment and Re-evaluation Management Directorate
Pest Management Regulatory Agency
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Outline
1. Update on Commissioner of the Environment and Sustainable
Development (CESD) Report on Pesticide Safety Recommendations
2. Pesticide Re-evaluation Update
– Recent proposals and decisions
– Special Reviews
– Re-evaluation of neonicotinoid insecticides
– Overview of use pattern information used in risk assessments
3. Summary of recent changes to re-evaluation program and upcoming
initiatives
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1. Update on Commissioner of the Environment and
Sustainable Development (CESD) Report on Pesticide
Safety Recommendations
The Commissioner of Environment and Sustainable Development tabled its audit of
Pesticide Safety in Parliament on January 26, 2016.
The audit included seven recommendations, focussed on the following:
– Conditional Registrations
• Ensure that registrants respect timelines for providing required information, and that PMRA
should assess the received data within two years.
– Cumulative health effects
• PMRA to finalize and apply methodology in risk assessments, as required.
– Re-evaluations of older pesticides
• Establish timelines to complete re-evaluations of actives registered before 1995
• Schedule of work is complete and up-to-date.
– Cancellation of pesticide registrations
• Act promptly to cancel pesticide registrations when risks are found to be unacceptable for all
uses.
– Communicating decisions to Canadians
• Maintain public registry to clearly communicate conditional registrations and their conditions
• Communicate timely information on cancellations, mitigation measures, prohibitions and
timing.
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2. Pesticide Re-evaluation Update – Recent Proposals
and Decisions
In response to the CESD audit, the PMRA developed some actions to
address the recommendations
– A 5-yr work plan on re-evaluations and special reviews was published
February 26, 2016.
– In 2016, PMRA will be consulting and developing a policy for
stakeholder engagement and submission of information for re-
evaluation
– In 2016, PMRA will be consulting and developing a policy on a phase
out approach of affected pesticides
Re-evaluation work plan to be updated and progress to be reported
annually
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2. Pesticide Re-evaluation Update – Recent Proposals
and Decisions
Proposed decisions (consultation open until March-April 2016)
- pyridaben (5 Feb 2016)
- fludioxonil (19 Jan 2016)
- methomyl (15 Jan 2016)
- acephate (8 Jan 2016, consultation ends on March 8th)
- update on chlorothalonil (11 Feb 2016)
- 4-aminopyridine (25 Feb 2016)
- ferbam (29 Feb 2016)
- thiram (29 Feb 2016)
- ziram(29 Feb 2016)
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2. Pesticide Re-evaluation Update – Recent Proposals
and Decisions
Proposed decision (consultation closed)
- glyphosate (13 Apr 2015)
- propamocarb (11 May 2015)
- prosulfuron (29 April 2015)
- imazamox (14 May 2015)
- octhilinone (23 Dec 2015)
- d-phenothrin (19 June 2015)
- deltamethrin (31 Dec 2015)
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2. Pesticide Re-evaluation Update – Recent Proposals
and Decisions
Final re-evaluation decisions which include new mitigation/revised
label directions
- triflusulfuron-methyl (23 Apr 2015)
- phosphine (27 August 2015)
• new mitigation measures to be implemented by 30 June 2016, including
new labelling.
- dimethoate (30 Dec 2015)
- prosulfuron (21 Dec 2015)
- 1,4-Bis(bromoacetoxy)-2-butene (6 March 2014)
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2. Re-evaluation Update - Special Reviews:
Special reviews were initiated for 23 actives, triggered by prohibition of all uses by
an OECD member country in December 2013.
Current status of the 23 special reviews:
Proposed decision released for : trifluralin (17 Dec 2015), atrazine (15 Dec
2015), fluazifop-p-butyl (22 July 2015), fluazinam (30 June 2015),
Final decisions for: aminopyralid (28 Nov 2014), quintozene (7 Jan 2016),
paraquat (23 Dec 2015), Imazapyr (7 Jan 2016)
– Paraquat: new classification as restricted class product, new use directions, including
additional PPE, to be implemented this use season (i.e. by April 1st 2016)
The remaining special reviews are ongoing
In 2015, 4 additional special reviews were initiated for: Naled, Dichloran,
pymetrozine and sodium chlorite, triggered by the prohibitions in OECD
member country
Following the special review initiation of dichloran, all products containing
dichloran were voluntarily discontinued (expiry: 31 Dec 2015)
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2. Re-evaluation Update - Neonicotinoid Insecticides
PMRA recent publications:
Re-evaluation Note REV2016-04, Joint PMRA / USEPA Re-evaluation
Update for the Pollinator Risk Assessment of the Neonicotinoid
Insecticides
– Status update
Re-evaluation Note REV2016-05, Re-evaluation of Imidacloprid-
Preliminary Pollinator Assessment
– Consultation open January 18 to March 18, 2016 (60 calendar days)
Re-evaluation Note REV2016-03, Value Assessment of Corn and
Soybean Seed Treatment Use of Clothianidin, Imidacloprid, and
Thiamethoxam
– Consultation open January 6 to March 6, 2016 (60 calendar days)
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REV2016-04: Re-evaluation update for the pollinator risk
assessment of the Neonicotinoids
Joint PMRA/US EPA Status Update on neonicotinoid pollinator re-evaluations
Pollinator assessments follow updated pollinator risk assessment framework
Considers all information available- public literature and registrant generated
Milestones for the Pollinator Assessments
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Dinotefuran is not currently registered in Canada
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Neonicotinoid Assessment PMRA/US EPA
Imidacloprid Preliminary Jan 2016
Final Dec 2016
Clothianidin Preliminary Dec 2016
Final Dec 2017
Thiamethoxam Preliminary Dec 2016
Final Dec 2017
Dinotefuran* Preliminary Dec 2016 [US only]
Final Dec 2017 [US only]
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2. Re-evaluation Update - Overview of Use Pattern
Information Used In Risk Assessment and Risk
Management
Use pattern information is used as the basis for initial risk assessment
and as required, in a tiered approach, in the refinement of the risk
assessment
Information on the use pattern (including agricultural practices) is also
used to develop risk management options that are considered feasible
and adoptable
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Use pattern information used in risk assessment
Example of parameters considered Label information related to use, e.g., application rate, maximum # of application per
year
Usage information: Percent crop treated (PCT)
Use description information: e.g., parameters related to handler (mixer/loader/
applicator) exposure and post-application exposure such as amount treated per day,
mixing/loading method, frequency and duration of Re-entry activities
Typical application timing (calendar dates) to input into the drinking water estimate
Typical application information such as rate, number of applications
Data sources include* Label
Proprietary use data
Registrants or Taskforce
Crop profile
Crop specialists
Grower associations
Other stakeholders
Verification of use pattern Mainly registrants or Taskforce
Sometimes other stakeholders
* Extent of use of these data sources will depend on gaps and the level of refinement required by the risk
assessment
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Use pattern information used in refinement of risk
assessment and risk mitigation
Use pattern information is also used for refining the risk assessment and
developing risk mitigation measures. When risk concerns are identified,
assessment includes a consideration of:
refined use pattern information, e.g., reduction in application rate or
number of applications
agronomic feasibility analyses on risk mitigation measures, e.g., re-
entry interval (REI), pollinator protection – restriction of use during
blooming
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Use-Related Tools and Databases
PMRA Pesticide Label Database
- Quick access to pesticide label information
- Effective tool for searching alternative pesticide products
Proprietary pesticide usage data
- Percent crop treated and market leader
- Typical application rate and number of applications
Crop related databases
- Statistics Canada - Crop production (area and commodity value),
percentile farm size, percent crop area
- Crop profiles
Data limitations
- Lack of data in some areas, especially for minor crops
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3. Summary of recent re-evaluation changes and
upcoming initiatives
Implemented technical briefing with registrants and affected
stakeholders prior to publication of re-evaluation proposals or
decisions
Consulting and developing a policy for stakeholder engagement and
submission of information for re-evaluation
- Will conduct a pilot approach for increased early stakeholder engagement
to provide input on the use pattern for use in risk assessment
Consulting and developing a policy on the phase out approach for
affected pesticides
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