PMRA Re-evaluation Update Canadian Horticultural Council Meeting

March 10, 2016

Margherita Conti

Value Assessment and Re-evaluation Management Directorate

Pest Management Regulatory Agency

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

*

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]

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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