**Working Group**  **Ag riculture & Food #3** 
**Ac tion**  **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)/tolera nces 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

**Ac tion**  **Items Ac**  **tion Item 1: Encourage Joint** 

**Submission of Use Expansions and Fully**  **A ligned**  **Labels** B uilding on the already established process of joint EPA/PMRA pesticide reviews, and in order to eliminate technology gap s 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

. **Ac tion Item 2:**  **Develop J oint G**  **uidelines for Residue Trials**  To m aximize the reliance on and acceptance of fo od 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 **Ac tion Item 3:**  **Ad dress**  **Obstacles to**  **Joint Registration** B uilding 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, enhanc ing t he use of existing tools to me asure progress , and develop ing new opportunities to align EPA and PMRA work and workplans. **Ac tion Item 4:**  **Al ign Data Collection**  **Processes/Procedures for Residue Trials** In order to support increased numbers of joint reviews of minor use expansions in PM RA and the EPA , PMC and IR

- 4 will al ign priorit i es and pro cedures to the fullest extent possible, including data collection and reporting proce sses 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 s ummit) to registrant community to discuss the joint submission of use expansions. The summ it would include such topics as: o I dentification of barriers; o P otential incentives ; o S ubmission of shared l abeling (NAFTA label) ; o J oint planning; and o F ormal submission process es. **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 IR

4/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 a nalysis 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**

 D evelop a process/strategy /governance structure fo r 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** 

 Exp lore fu rther 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 Ide ntify 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 fo r 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.

 Re view the possibility of combining efficacy field trials and residue field trial s. **PMC 6**  **- 12**  **Months**  J oint ly review IR

- 4/PMC data supporting

the pilot application over a ne gotiated timeline of 15 months. **PMRA and EPA** 

 Ba sed on the results of initial registrant community outreach efforts , work internally and with stakeholders to resolve barriers to joint submission of us e expansions, product amendments, and shared labels. **PMRA and**  **EPA**

 Initiate discussions on the development of a n incentive s process for joint submission of use expansion s , 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 p roportionality 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 wh ich 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 al igning 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

mee tings 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**   C omplete gap analysis of data collection procedures to identify key differences:

- H old pilot for implementing alignment on joint residue studies. **PMC and IR**  **- 4** 

 A lign the workplan for joint projects for joint review by EPA/PMRA:

- D etermine 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.

- U ndertake more joint projects

. **PMRA ,**  **EPA , IR**  **- 4 a**  **nd PMC**

 Achievement of agreement on data collection procedures and reporting to the fullest extent possible. **PMRA and**  **EPA Bey**  **ond 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 (l ong - 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 i mplement aligned regulatory processes and establish a committee to continue alignment

. **PMRA and EPA** 

 Measure successes by evaluating the number of uses , new a ctive i ngredients 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 workplan s fo r joint projects for joint review by **PMRA ,**  **EPA , IR**  **- 4 and PMC.** 

 Ma intain o ngoing 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 (long

term; must allow time for process). **PMC and IR**  **- 4**