Working 

Group Agriculture & Food #3

Action 

Plan 

Initiative

Crop Protection Products

Deliverable 

outcome

Identify mechanisms to encourage registrants to submit applications for joint regulatory review to Canada and the US that include increased numbers of minor uses. This will help 

facilitate equal access to products and uses in both countries, as well as align maximum residue limits (MRLs)/tolerances where possible, in cases where the application is based on 

data generated with Canadian or US government support on minor uses and specialty crops. The goal is to facilitate equal access to effective means of pest control in both countries 

as well as to align MRLs whenever possible.

Task team 

members

Marion Law, PMRA

Lois Rossi, EPA

Manjeet Sethi, PMC

Jerry Baron, IR-4

Action 

Items

Action Item 1: Encourage Joint 

Submission of Use Expansions and 

Fully Aligned Labels

Building on the already established process 

of joint EPA/PMRA pesticide reviews, and 

in order to eliminate technology gaps and 

trade irritants, PMRA and EPA will work 

toward the simultaneous receipt of fully 

aligned labels and submission packages 

and the development of one joint 

submission workplan for all actions related 

to use expansions. 

Action Item 2: Develop Joint Guidelines

for Residue Trials

To maximize the reliance on and 

acceptance of food safety data generated in 

either country to support regulatory 

decisions, PMRA and EPA will develop joint 

guidelines for generation of residue field 

trial studies. 

Ultimately, each country/agency could 

accept the other’s review; and the review 

would result in concurrent, aligned 

decisions 

Action Item 3: Address Obstacles to 

Joint Registration 

Building on already established cooperation 

on the joint review of pesticides, PMRA and 

EPA will eliminate regulatory obstacles 

preventing the joint submission of pesticide 

applications into the US and Canada by 

identifying flexibilities in regulatory 

processes and procedures, enhancing the 

use of existing tools to measure progress,

and developing new opportunities to align 

EPA and PMRA work and workplans.

Action Item 4: Align Data Collection 

Processes/Procedures for Residue Trials

In order to support increased numbers of 

joint reviews of minor use expansions in 

PMRA and the EPA, PMC and IR-4 will 

align priorities and procedures to the fullest 

extent possible, including data collection 

and reporting processes and workplans. 

As for Action Item 2, this alignment would 

mean that either PMC or IR-4 could lead 

the development of the residue data; each 

country/agency could accept the other’s 

review; and the review would result in 

concurrent, aligned decisions (either 

registration and MRLs in both countries, or 

registration and MRL in one country with an 

MRL in the other). 

Interim Deliverables
3-6 Months

Tasks:

 Conduct outreach (e.g., a summit) to 

registrant community to discuss the joint 

submission of use expansions. The 

summit would include such topics as:

o Identification of barriers;

o Potential incentives;

o Submission of shared labeling

(NAFTA label); 

o Joint planning; and

o Formal submission processes.

EPA and PMRA 

 Initiate the planning and submission of a 

pilot application of an aligned joint 

submission for a use expansion that 

includes a significant number of minor 

uses and domestic and import MRLs/ 

tolerances. Pilot application will use IR4/PMC data. EPA, PMRA, IR-4, PMC

Tasks: 

 Review existing and ongoing work to 

determine highest value priorities for 

future joint review of use expansions.

PMRA and EPA

 Continue the development of 

harmonized crop groups to leverage 

least amount of data to the maximum 

number of crops/uses. PMRA, EPA, 

IR-4, and PMC

 Establish a PMRA/EPA workgroup to

explore the concept of proportionality of

pesticide residues. PMRA and EPA

Tasks:

 Initiate analysis of current registration in 

each country to identify areas that are 

not aligned, including submission 

formats, application forms, product

specification forms. PMRA and EPA

 Identify guidance documents, directives, 

and policies which could be revised to 

align registration processes which occur 

in both Canada and US. (See also 

Action Item 2 – registrant community 

outreach) PMRA and EPA

 Develop a process/strategy/governance 

structure for addressing roadblocks, 

elevating issues, and working through 

barriers. These barriers can include 

disharmonized processes and/or

differences in decisions, policies, 

regulations and laws. PMRA and EPA

 Explore further aligning positions to 

Codex. PMRA and EPA

Tasks:

 Initiate gap analysis of data collection 

procedures to identify key differences.

PMRA, EPA, PMC and IR-4:

o Identify differences between US 

and Canadian study protocols 

and final residue reports.

o Confirm adoption of OECD field 

trial template for final study 

report. 

 Initiate alignment of workplan for joint 

projects for joint review by EPA/PMRA

PMC and IR-4:

o Actively outreach to 

stakeholders to identify priorities 

and potential joint projects.

o Explore the possibility of holding 

a joint food use workshop.

 Review the possibility of combining 

efficacy field trials and residue field 

trials. PMC
6-12 

Months

 Jointly review IR-4/PMC data supporting

the pilot application over a negotiated

timeline of 15 months. PMRA and EPA

 Based on the results of initial registrant 

community outreach efforts, work 

internally and with stakeholders to 

resolve barriers to joint submission of 

use expansions, product amendments, 

and shared labels. PMRA and EPA

 Initiate discussions on the development 

of an incentives process for joint 

submission of use expansions, including 

the possible assignment of a certain 

regulatory status or classification (e.g., 

a RCC registration), if certain criteria 

are met (i.e., use expansions and 

registrations are submitted jointly; 

shared labeling; etc...). PMRA and 

EPA

 Develop the criteria for an incentive 

process and identify submissions that 

may qualify to be considered as pilots. 

PMRA and EPA

 Establish a PMRA/EPA workgroup to 

consider:

o The exchangeability and 

translation of food safety data 

among regions and between 

countries.

o Developing the principles of a 

joint field trial guideline. PMRA

and EPA

 Analyze the results of the determination 

of proportionality projects to establish 

criteria for use of these concepts to 

support registration. PMRA and EPA

 Initiate and complete the appropriate 

legislative process required to adopt 

policy or regulatory changes in both 

countries (e.g. change to crop grouping, 

policy on adoption of food safety data, 

etc.). PMRA and EPA

 Using the analysis of current registration 

in each country, construct a plan to 

move towards alignment. PMRA and 

EPA

 Develop a process/strategy to identify 

and address existing technology gaps 

and trade irritants, particularly those 

identified in the US/Canada Grower 

Priority Database. PMRA and EPA

 Initiate discussions of the feasibility of 

developing joint guidances, directives 

which meet the legislative needs of both 

countries but align registration 

processes. PMRA and EPA

 Develop action plan and timelines to 

revise documents identified in above 

tasks. PMRA and EPA

 Ongoing gap analysis of data collection 

procedures to identify key differences.

- Identify differences between US and 

Canadian raw data field notebook 

(RDFN) and analytical summary 

report.

- Obtain agreement on aligning data 

collection procedures and reporting; 

undertake more joint projects.

PMRA, EPA, IR-4 and PMC

 Develop options for aligning the 

workplan for joint projects for joint 

review by EPA/PMRA:

- IR-4 and PMC: Introduce to 

stakeholders at 2012 individual food 

use workshops the vision of moving 

towards holding a joint food use 

workshop. PMRA, EPA, IR-4 and 

PMC
12-18 

Months

 Review the pilot submission. Hold team 

meetings between EPA and PMRA 

evaluators to discuss science findings, 

make decisions in both countries, and 

prepare decision documents. Discuss 

feasibility. PMRA and EPA

 Pilot a program between PMC and IR-4 

and registrants to develop residue field 

trial data on commodity/commodities

based on draft guideline principles and 

recommendations from the PMRA/EPA 

workgroup. PMRA, EPA, IR-4, and 

PMC

 Continue the development of 

harmonized crop groups. PMRA and 

EPA

 Engage stakeholders to obtain feedback 

and input. See also Action Item 2 and 

stakeholder outreach. PMRA and EPA

 Explore feasibility of process change to 

re-evaluation of pest control products.

PMRA and EPA

 Complete gap analysis of data 

collection procedures to identify key 

differences:

- Hold pilot for implementing 

alignment on joint residue studies. 

PMC and IR-4

 Align the workplan for joint projects for 

joint review by EPA/PMRA:

- Determine feasibility and potential 

options for holding a joint food use 

workshop through consultation with 

stakeholders. 

- EPA/PMRA develop a joint 

screening process for review of 

projects prior to workshop.

- Undertake more joint projects.

PMRA, EPA, IR-4 and PMC

 Achievement of agreement on data 

collection procedures and reporting to 

the fullest extent possible. PMRA and 

EPA

Beyond 18 

Months

 Evaluate the successes and potential 

improvements to the pilot submission. 

Identify challenges, obstacles, and 

areas to improve the approach. 

Determine the feasibility of adopting this 

approach as a best practice. PMRA and 

EPA

 Measure successes by evaluating the 

number of uses established jointly

currently and after 12-18 months and 

the current status of trade irritants and 

technical gaps [using existing tools, 

such as the grower priority databases 

and MRL databases]. PMRA and EPA

 Data generated by pilot project 

submitted to EPA/PMRA for review and 

evaluation for acceptability (long-term; 

must allow time for data generation). 

PMC and IR-4 and registrants

 Implement joint field trial guideline. 

(long-term; must allow time for approval 

process in both countries) PMRA and 

EPA

 Consider development of harmonized 

guidance for all commodities. PMRA

and EPA

 Develop and implement aligned 

regulatory processes and establish a 

committee to continue alignment. 

PMRA and EPA

 Measure successes by evaluating the 

number of uses, new active ingredients

registered, and the current status of 

trade irritants and technical gaps [using 

existing tools, such as the grower 

priority databases and MRL databases].

PMRA and EPA

Ongoing work towards alignment of 

workplans for joint projects for joint 

review by PMRA, EPA, IR-4 and PMC.

 Maintain ongoing dialogue to ensure 

alignment is maintained (i.e. If one 

country wants to make a change or 

international standards change). PMRA, 

EPA, IR-4 and PMC

 Develop the process for holding a joint 

food use workshop. PMC and IR-4

 Hold joint food use workshop (longterm; must allow time for process). PMC 

and IR-4