NATIONAL WORKSHOP ON FERTILIZER PROGRAM MODERNIZATION

Meeting Notes
March 28-29, 2007
Albert at Bay Suite Hotel
Ottawa, Ontario

PDF (765 kb)

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Table of Contents

BACKGROUND AND INTRODUCTION

Welcome and Opening Remarks
Overview of the Modernization Initiative

REPORT ON PROGRESS AND ACCOMPLISHMENTS

Presentation on Progress and Accomplishments
Networking Opportunities to Learn About Fertilizer Projects
Service Delivery Standards and Product Assessment Re-engineering

CONSULTATIONS OUTCOMES

Canadian Fertilizer Products Forum: Presentation and Review of Work Completed
Outcomes of the Regional Consultation

THEMATIC DISCUSSIONS

Efficacy Data Requirements
Biosolids Regulation
Compliance and Enforcement
Product Assessment and Service Delivery Standards
Enhanced Feed Ban Regulation

PRODUCT SPECIFIC DISCUSSION

Microbial Supplements
Micronutrients
Speciality Fertilizers
Chemical Supplements
N, P, K Fertilizers
Waste-derived materials / Biosolids

NEXT STEPS AND CLOSING REMARKS

APPENDIX A - TABLE REPORT BOOK NOTES FROM THE THEMED DISCUSSION

Efficacy Data Requirements
Biosolids Regulations
Compliance and Enforcement - Group 1
Compliance and Enforcement - Group 2
Product Assessment and Service Delivery Standards
Enhanced Feed Ban Regulation

APPENDIX B - TABLE REPORT BOOK NOTES FROM THE PRODUCT-SPECIFIC DISCUSSION

Microbial Supplements
Micronutrients
Speciality Fertilizers
Chemical supplements
N, P, K Fertilizers
Waste-derived materials

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Background and Introduction

This report summarizes the discussions that took place at the National workshop on the Fertilizer Program Modernization held March 28 and 29, 2007 at the Albert at Bay Suite Hotel in Ottawa, Ontario.

The objectives of the meeting as stated in the agenda were to:

• Provide participants with a progress report on the modernization initiative and program changes underway;
• Share outcomes and results of the regional consultations;
• Obtain participant input on program priorities for the next 12 months and confirm the strategic action plan direction.

The workshop was divided in three parts. In the first part, the CFIA presented a report on the progress and accomplishments that were made to date. The second part focused on sharing the results from the CFIA regional consultations and the work being conducted by the Canadian Fertilizer Products Forum. In the third part, participants were provided with an opportunity to discuss cross-cutting and product-specific issues related to the Fertilizer Program. Copies of the presentations are available upon request from:

Canadian Food Inspection Agency
Plant Production Division
Fertilizer Section
2 Constellation Crescent
Ottawa, Ontario, K1A 0Y9
CANADA
Email: fertilizer@inspection.gc.ca
Telephone: (613) 221-7519
Fax: (613) 228-4552

There were 74 participants on the first day (March 28^th) and 89 on the second (March 29^th). The participants represented a diverse group of stakeholders including industry, other levels of Government, producer organizations, interested parties and regional CFIA staff.

Welcome and Opening Remarks
Glyn Chancey, Director, Plant Production Division, CFIA

Glyn Chancey began the workshop by welcoming the participants and thanking them for taking the time out of their busy schedules to attend the meeting. He explained that this workshop followed the National Workshop on Seed Program Modernization, a parallel initiative undertaken by the Seed Program. Glyn Chancey emphasized the importance and value of stakeholder input during these consultations and how it has contributed to the Fertilizer Program's Strategic Action Plan.

Overview of the Modernization Initiative
Glyn Chancey, Plant Production Division, CFIA

To set the context for the workshop, Glyn Chancey provided an overview of the modernization initiative. He started by explaining the origins of the initiative which emerged from the SMART Regulation pilot project. The key drivers for the Fertilizer Program modernization included decreasing product compliance, significant file submission backlog and delays in new product registrations which originated as a result of chronic under-funding of the program and ensuing staff shortages. The goals of the initiative are to improve the regulatory framework; minimize unnecessary regulatory burden; streamline product assessment and approval process (without compromising the safety and consumer protection standards); promote innovation and growth of the industry sector, and to meet the growing needs of all stakeholders. Another important goal is to strengthen the program's consultative capacity.

Glyn Chancey noted some of the work that has been accomplished to date most notably the series of stakeholder consultations and the internal review of the program's performance and delivery mechanisms which together have led to the development of a Strategic Action Plan for the Fertilizer Program. Glyn Chancey concluded by reminding the participants of the objectives of the workshop and that the key objective was to engage all stakeholders in the Fertilizer Program modernization initiative.

Report on Progress and Accomplishments

Presentation on Progress and Accomplishments
Ryan Ring, A/ National Manager, Fertilizer Section, CFIA

Ryan Ring provided a progress update on the work completed by the Fertilizer Program over the course of last year and highlighted program changes currently under way. He mentioned that enhancing the co-operation with stakeholders and the establishment of the Canadian Fertilizer Products Forum (CFPF) were two important accomplishments that have contributed to the overall progress of the modernization initiative. The program has also developed service delivery standards which have been presented for consultation in a form of a Trade memorandum (30 day review and comment period). Other program changes/accomplishments included:

• Improvements to program administration including re-structuring of the Fertilizer Section and regional program staff;
• Regulatory amendment to extend the registration period from 2 to 3 years;
• Development of implementation policies for the Enhanced Feed Ban Regulations;
• Revision of the regulatory framework for research trials;
• Conducting literature reviews and revising efficacy requirements for micronutrients in the oxide from;
• Revising regulatory requirements (safety and efficacy) for phosphite fertilizers;
• Making improvements to the submission review process;
• Establishing inter-office procedures with Plant Health for review of import permits;
• Exploring quality assurance models to increase the effectiveness of marketplace monitoring activities (review of the Canadian Fertilizer Quality Assurance Program for bulk blends and the Canadian Quality Alliance program for compost).

Ryan Ring also shared some statistics on the number of submissions that were received, reviewed, and closed in 2006-2007.

After the presentation, participants had an opportunity to ask questions. The following summarizes the key discussion points.

• One participant asked how will interested parties be informed of the 30-day comment period on the proposed service delivery standards? Ryan Ring explained that the document will be sent out via the CFIA notification system and will also be distributed to all CFPF members.

• Ryan Ring clarified the terms used on the submission statistics slide.

  • Closed - refers to submissions that have been completed and closed
  • Under review - refers to submissions that have been assigned to and are being reviewed by an evaluator
  • On hold - includes submissions that are waiting for additional data from the applicants
  • In queue - refers to submissions that were received and screened, but that have not yet been reviewed by an evaluator
• A participant wondered if it was appropriate to assume that the number of submissions reviewed or in the process of being reviewed would add up to the number of submissions received. Ryan Ring explained that the number of submissions received was lower than the number of submissions that were reviewed or being reviewed in 2006-2007 because some of the files reviewed in 2006-2007 were received in previous years. In other words, the submissions that were reviewed or being reviewed were not necessarily those that were received the same year due to the backlog.

• The Fertilizer Section knows how many files are new registrations, re-registrations etc., however, further analysis would be required to obtain the amount of submissions per product type (i.e., micronutrients, microbial supplements, fertilizers, etc.).

Networking Opportunities to Learn About Fertilizer Projects

During the workshop, the participants were provided an opportunity to learn more about the various fertilizer projects and accomplishments and to network with other stakeholders and CFIA staff. Large posters were prepared by the Fertilizer Section to describe each project and the outcome. The CFIA project lead was present at each poster to describe its contents and to answer questions. There were seven posters in total:

• Requirements for Phosphite and Phosphorus Acid Materials represented for use as fertilizers
• Safety assessment of Bacillus subtilis
• Safety assessment of Indole-3-butyric acid on food crops
• Revised guidelines for research authorizations for testing novel supplements
• Service delivery standards
• Enhanced Feed Ban Regulations and its impacts on the Fertilizer Program
• Organizational Chart

Service Delivery Standard and Product Assessment Re-engineering
Benoit Dubé,A/Chief Program Design and Delivery Unit, Fertilizer Section, CFIA

Benoit Dubé presented the proposed service delivery standard and described the product assessment re-engineering project. He began his presentation by providing historical context on the issues and the need for service standards. The purpose of this project was to increase the predictability and consistency of the registration process and to establish tools to support performance measurement and reporting. Benoit pointed out, that as a first step, the section developed a service standard for registration related submissions only (i.e., new registrations, re-registrations, minor and major amendments and "me-too" registrations). He further explained the principles and methodology used in the development of the standard, and introduced the interim and target time lines for submission review and processing. He emphasized that this service delivery standard and the associated time standards are preliminary and will be subject to change and continuous improvement as the modernization initiative moves forward. As part of the standard development and implementation the Fertilizer Program is proposing to establish complaint and redress mechanisms for clients that are not satisfied with the service and feel that the standards have not been met. Clients themselves will also be responsible for ensuring that the time standards are met by providing complete submissions and responding to additional requests for information in a timely manner.

In addition to the development of the service delivery standard other improvements to the product assessment and file processing are currently under way:

• hiring a consultant to review the product assessment and file flow procedures and to propose options to improve the overall efficiency and timeliness of the process;
• identifying and implementing new tools (including new software, databases etc.) to improve the tracking of files and allow for electronic submissions in the future;
• developing internal procedures to ensure consistency between evaluators;
• publishing comprehensive guidelines for registrants on how to prepare a complete submission.

Benoit Dubé concluded his presentation by mentioning that that the service standards are achievable only if the backlog is resolved and if the section is adequately staffed. The Fertilizer Section will continue to collect data and adjust the standards as improvements are made to the regulatory and policy framework and the file review process.

After the presentation, participants had an opportunity to ask questions. The following summarizes the key discussion points.

• If the requirements were clearly communicated to the industry the overall review time of submissions would be shortened and consequently the amount of personnel required at CFIA would be reduced. Benoit Dubé explained that there are some mechanisms currently in place to ensure completeness of submissions and to help applicants provide the necessary documentation. For example, during the pre-screening stage, the CFIA evaluators check if all required documents have been provided. In addition, prior to re-registration a letter is sent to the registrant detailing the required documentation (checklist).

  A guideline/checklist on the submission requirements is expected to be available on the CFIA website shortly. The CFIA may still request additional supporting documents/information after reviewing the file. In these situations, it is important for the applicant to respond in a timely fashion to accelerate the registration process.

• A fertilizer-pesticide product is an example of a new registration that would not need data. Even though fertilizer-pesticides do not require data, the application must include a marketplace label and all the administrative information. CFIA can evaluate efficacy and safety in house without using data produced by a third party service provider.

• It was suggested that registrants who provide completed submissions should be given a rebate on their submission fee.

• Some participants were wondering if timelines were established to eliminate the backlog. The Fertilizer Section has hoped to resolve the backlog during the past two years, however due to ongoing staff turnovers and heavy project workloads complete elimination of the backlog was not achieved. Even though significant progress has been made (particularly with respect to efficacy data reviews) concerted effort from the staff will be required to return the file numbers to baseline levels (300-400 active submissions) Also important will be to strike a balance between reviewing submissions and working on policy development. To address this, the evaluators will be spending a specified amount of time on evaluating files.

• Some participants felt that the proposed time standard of 530 working days for new registrations, re-registrations with data and major amendments was too long. One participant asked if it was possible to use data and outputs from other countries that regulate fertilizer and supplement products to reduce the review time. Benoit Dubé explained that the time standard includes the actual review time but also the time the file is waiting in the queue to be reviewed. Data gathered in other countries and/or provided to other jurisdictions is accepted as long as the trial conditions (climate, soil, crops etc.) are comparable to Canadian conditions.

• The proposed service standard and time standards are reflective of the current process. It is anticipated that as the extension of the registration period to 3 years is implemented and other changes/improvements to the program are made the time standards will be reduced. Benoit Dubé also mentioned that removing the anniversary date of June 30^th will help with the distribution of work and as such contribute to a reduction in the review times.

• There are three components to the time standard (1) the time the file waits to be reviewed, (2) the time spent by an evaluator to review the file and (3) the time the file is waiting for additional information from the applicant.

• " How can industry help reduce the number of inquiries received by the CFIA?"
  Industry should research/learn about the requirements prior to contacting the CFIA. On the other hand, the CFIA should ensure that policy and guidance documents are comprehensive and accessible (available on their website). Some stakeholders suggested that the CFIA should develop e-learning tools for applicants to help them learn about the submission process and better understand the requirements. It is easier to acquire the information through an interactive tool as opposed to reading it in a Trade Memorandum.

Consultations Outcomes

Canadian Fertilizer Products Forum: Presentation and Review of Work Completed
Clyde Graham, Vice-President, Strategy and Alliances, Canadian Fertilizer Institute and Executive Director, Canadian Fertilizers Products Forum

Clyde Graham began his presentation by explaining how the "Canadian Fertilizer Products Forum" came to be and by highlighting the importance of the fertilizer industry in Canada. He described that the CFPF was an industry-driven two-year project based on months of stakeholder consultation. It was established to facilitate the development of consensus-based advice to government that would support the modernization of the regulatory system for fertilizers and supplements. He continued by outlining the specific objectives of the forum, the need for such a forum, the members of the executive team and the overall membership of the organization. He explained that the CFPF has created the following five working groups to address policy development issues: (1) Regulatory Efficiency WG, (2) Marketplace Monitoring WG, (3) New Products WG, (4) Communications and Operating Environment WG and (5) Biosolids WG. The CFPF executive is also working towards developing a strategic plan to guide activities of the forum and sustain its operation in the longer term. Clyde Graham concluded by encouraging individuals to join the forum and at a minimum sign up to receive information about their ongoing work.

After the presentation, one participant mentioned that many products were being imported from countries where production costs are lower due to lower price of natural gas. The participant was wondering what the forum was doing to ensure that these products meet Canadian standards. Clyde Graham responded by saying that he believed there was a strong future for nitrogen production in Canada and that the standards established by the CFIA should also be imposed on imported products. He mentioned that members of the forum, who import urea, spend a significant amount of money to ensure that the product crossing the border is high-quality.

Outcomes of the Regional Consultation
Ewa Madey, A/Chief Biological Evaluation and Policy Unit, Fertilizer Safety Office, CFIA

Ewa Madey presented the outcomes of the regional consultations. The intent of these regional workshops was to broaden the CFIA consultative scope, develop a common understanding of the current Fertilizer Program among stakeholders and to actively engage them in the modernization initiative. Regional CFIA staff from the Operations and Science Branches were also invited to attend the workshops. Five regional workshops were held between January and March 2007 in Calgary, Vancouver, Moncton, Guelph and St-Hyacinthe. Ewa Madey described the workshop structure and continued by sharing some of the key results of the workshops. One of the key elements of the workshops was discussion and validation of the Strategic Action Plan. Ewa Madey pointed out that there was a general agreement among workshop participants that the SAP was comprehensive and captured most issues facing the Fertilizer Program and the sector. The participants offered suggestions to improve the SAP by including project completion timelines in the document, prioritizing the strategies, regularly updating the SAP and ensuring that adequate funding is secured to implement the strategies in a timely fashion. Ewa Madey noted some common issues and recommendations that were provided by the workshop participants across all locations. These related to staffing challenges, time to market for fertilizer and supplement products, the product assessment process, labelling, regulatory coordination, marketplace monitoring, compliance and enforcement, communication, and implementation of the Enhanced Feed Ban regulations. She also highlighted differences in regional perspectives. Finally, Ewa Madey shared the recommendations for effective stakeholder engagement that were identified during the regional sessions and some of the performance measures that the CFIA could use to gauge the success of the modernization initiative and the overall effectiveness of the Fertilizer Program.

After the presentation, participants had an opportunity to ask questions. The following summarizes the key discussion points.

• One participant from the Organic Community mentioned that he knew very little about fertilizer but was willing to provide additional information about Organic Standards to those that were interested.

• Unlike PMRA, the CFIA does not have a program that monitors fertilizers imported for personal use (fertilizers other than fertilizer-pesticides imported for direct application to the soil by the importer and not for sale in Canada are exempt from the provisions of the Act and Regulations). Ewa Madey explained that the CFIA is considering surveying products imported for personal use as an indicator of technology gaps (types of products that are needed or wanted by the agricultural sector but not available in Canada).

• One of the recommendations from the regional workshops was to strengthen CFIA's response to complaints by creating a mechanism for companies and the public to submit them online. One participant shared his concerns with this approach. He felt it might overload the system and false complaints could be damaging to both CFIA and the company being accused. He suggested that CFIA should invest in additional training for the inspectors to verify the validity of complaints and that these types of issues should be addressed at a local level. Ewa Madey acknowledged the comment and explained that currently when complaints are received, the CFIA inspectors follow up to ensure that the complaints are valid before any action is taken.

Thematic Discussions

At the regional workshops the participants were asked to identify and discuss priority areas/strategies for the next year. The results of the regional workshops contributed to the development of a workplan for the Fertilizer Program for the upcoming year. Participants of the national workshop had the opportunity to discuss the various priority themes identified in the workplan. These included:

1. Efficacy Data Requirements
2. Biosolids Regulation
3. Compliance and Enforcement
4. Product Assessment and Service Delivery Standards
5. Enhanced Feed Ban Regulation

Participants were invited to select a theme they wished to discuss. To guide the discussion, participants were provided with a list of strategies identified in the SAP that related to their particular topic of discussion.

Following the thematic discussions the participants were asked to share they key messages in plenary. The following identifies key messages that were raised under each theme. Additional notes from the discussions that were included in table report books are available in Appendix B.

Efficacy Data Requirements

• Re-introduce provisional/temporary registrations. There could be benefits to both crop producers and manufacturers as it provides practical feedback on the performance of the product. The label should clearly indicate that the product is "Temporarily registered", so producers are aware of what they are purchasing.
• Reduce efficacy requirements for co-formulants and slight formula changes. These products should not have to "re-prove" themselves.
• Redefine the Canadian agro-climatic zones to create more practical zones based on crops and growth zones (i.e. delineate Ontario/Manitoba border)

Biosolids Regulation

• Create a baseline of different regulations at federal, provincial and municipal levels and identify jurisdictional overlaps, standards and science available on biosolids. Regulatory coordination is necessary to effectively regulate biosolids.
• Develop a T-memo on biosolids which clearly delineates the requirements and provides a definition of "biosolids".
• Educate the industry and the public about biosolids, their value, safety and benefits associated with their use.

Compliance and Enforcement

• Specialized inspectors are required for the Fertilizer Program. Inspectors should only be responsible for the delivery/administration of a limited number of programs to make sure that there is sufficient expertise and resources to monitor compliance.
• CFIA needs to maintain scientific expertise in the laboratories and explore utilization of services provided by accredited labs for testing and analysis.
• Address issues associated with importation of non-compliant products by stopping them at the border. Require importers to identify and guarantee the ingredients in the product. This has been partially addressed by updates to the AIRS system which are currently ongoing.
• Develop strengthened enforcement tools and implement other options such as AMPs. Possibly make CFQAP mandatory.
• Ensure continuous communication between Operations and Programs so that all parties have a common understanding.
• Define and publish sampling procedures. These should identify how the samples should be taken and handled.
• CFIA should deal with unregistered products that are being sold by targeting products at the distributor level.
• Document and publish enforcement actions and procedures for industry to help them better understand how enforcement decisions are made.

Product Assessment and Service Delivery Standards

• Improve communication and transparency by improving the website and including a flowchart with links to relevant resources and documentation.
• Develop e-learning and other training tools to assist registrants and potential registrants in preparing submissions and learning about the process.
• Streamline the submission process to reduce service delivery time (i.e. create a tiered submission system)

Enhanced Feed Ban Regulation

• Ensure that every player knows about the new regulations and properly enforce them
• Minimize costs to industry as a whole; most costs will be incurred by producers.
• Retailers and wholesalers are not ready or willing to implement the tracking system (record keeping, recall procedures). Most of the burden of the tracking system falls on them.
• What will happen on July 13^th 2007?

Product Specific Discussion

The last part of the workshop was devoted to product-specific or sector-specific discussions. The participants were invited to sit at one of the six tables and discuss issues and challenges that are potentially unique to their particular sector:

1. Microbial supplements
2. Micronutrients
3. Speciality fertilizers
4. Chemical supplements
5. N, P, K Fertilizers
6. Waste derived materials / Biosolids

The following summarizes the key messages that were shared by each group. Additional notes from the discussion were included in table report books and are presented in Appendix C.

Microbial Supplements

• Define and document the type of data that is required to prove that a novel product is efficacious and substantiate a given label claim. Manufacturers/developers of products would like to know these requirements before initiating the development process.
• There are concerns about not being able to import large quantities of a given product. Some manufacturers cannot produce sufficient quantities themselves and would need to import large quantities.
• Organic farmers are concerned with GM microorganisms entering their pastures, as it could impact their organic certification for few years.
• Clarify how combined supplement-pesticide products are regulated

Micronutrients

• Clarify and communicate the requirements for micronutrients. Why use the requirements for supplement testing (T-4-108) for micronutrients. Micronutrients are different and should be treated differently.
• Existing tolerance levels are difficult to meet given the current manufacturing practices.
• Some participants proposed placing micronutrients on Schedule II (i.e., they would be regulated for safety, efficacy and proper labelling, but would not require registration). This would reduce the number of submissions and alleviate the backlog.
• Facilitate the process for importing bulk-blend products from the U.S. that include registered micronutrients. These products should be treated like "me-too" registrations and there should be a 30-day turn around time to get the product approved for sale in Canada.

Speciality Fertilizers

• Tolerances for guarantees of blended N, P, K fertilizers and micronutrients are difficult to meet when blending large quantities, because the product must meet a minimum level for N, P, K and be within a specific range for micronutrients. Suggestions to improve this issue are:
  • Establish maximum levels across the board for micronutrients and minimum levels for N, P, K. The product should be approved if it meets these requirements.
  • Expand tolerance levels for micronutrients.
  • Establish maximum levels for N, P, K.
• Further discussion is required to address regulation of speciality fertilizers.

Chemical Supplements

• The regulatory standards for chemical supplements in Canada and the United State are different. Furthermore, there are inconsistencies in standards among the different States. For example, some states require only a MSDS while other states require additional information.
• Canada requires more information which takes more time for CFIA to review.
• Standardize data requirements between Canada and the United States.

N, P, K Fertilizers

• There are concerns with the quality and consistency of the primary product (i.e. the prill). If the product is crumbly or powdery, there can be problems with moisture which makes it difficult to apply the product.
• Customers are less concerned with the blend and more concerned with the weight they are paying for.
• Review international standards to verify that they meet Canada's regulations.

Waste-derived materials / Biosolids

• Definition of biosolids needs to be clarified and made consistent across the country.
• Transparency is important. CFIA needs to clearly communicate how the standards were determined, how the thresholds have been identified and what is considered acceptable and safe.
• Clarify standards and explain what will be analyzed for especially with respect to organic contaminants.

Next Steps and Closing Remarks

Glyn Chancey closed the meeting by thanking the participants for attending and for their valuable contribution. He also noted that improving compliance and addressing the backlog were key priorities for the Fertilizer Program. He also indicated that increased efforts are needed to ensure that the policies are clear and applied consistently across Regions. Although setting the services standards was an important step, outstanding resourcing issues will need to be addressed to ensure expeditious product assessment and review. Finally, Glyn Chancey concluded by thanking the CFPF for their contributions and continued support.

Appendix A - Table Report Book Notes from the Themed Discussion

Efficacy Data Requirements

• Acceptance of overseas data
  • Borrowing policy from PMRA and AAFC to re-define policies on efficacy data requirements. Prepare a rough draft in the next year.
• Need exact requirements for registration
• Reviews are being done to develop criteria for acceptance of foreign efficacy data with rationale and with a component of testing conducted in Canada (i.e. Sugarcane in Florida can be used as supplemental information but not main)
• Create zones for specific crops in foreign countries for data acceptance
  • CFIA wants to change Canada zones. Others countries need supporting rationale.
  • Need more representative division based on crop zones
  • Reduction of testing requirements
  • Possible 50% rule, up to 50% may come from outside Canada. Reduce Canada testing to 1 year.
  • Reduction in significance level
• Clarify what kind of efficacy data is needed for different types of claims.
• Efficacy task force bring forth suggestions only for products currently regulated under FzA
• Efficacy requirements are the maximum that a product will be suggested to do and not necessarily field trials, minimum guarantees and other claims.
• Slow release N - No consideration of environmental footprint (currently not taken into consideration). CFIA looks for plant response. "Enhanced efficiency" can use 10% or less, if proven through trials then it is acceptable to place statements on labels.
• Not looking at overall benefit only claims and guarantees must be shown.
• Bacillus subtilis - if no claims on enhancement, can indicate on label that is present? If claiming an active ingredient on level, must show in trials that it works (Guaranteed analysis = claims)
• All microbial supplements require registration and supporting trial data. Current standards require two years of trial data.
• Formalize product requirements for bringing products to the market sooner. There use to be trial registration if product is safe, however, to reinstate it require a regulatory change
• How to bring international products for other crops into the market sooner? Must choose the right agricultural zone and crop and show trial data.
• CFIA tries to protect the producer. Producer finds that the product does not work and does not use it again. The work gets around and the company looses. Temporary registration would enable the product to be tested by farmers, which would be easier on the company. This gives the market the opportunity for testing and two years of profit. If it works, the register the product with the data. If it does not work, then remove the product. This would require a regulatory change with low negative impact and can potentially be put through Canada Gazette easier. (General agreement from the table)
• Commercial implementation allows companies to see practical use of the product and to receive feedback from the customer.
• Argentina has a temporary registration for limited quality in commercial market for more progressive growers (assuming producer will buy the product).
• The producer at the end of the day will know what products they want and what really works. Producers are under financial pressure. This puts the game into the growers hand who will be involved in the efficacy assessment. This need to be done and controlled in a quantitative manner that is monitored by field inspectors.
  • Will bring stakeholders together.
• Will bring stakeholders together.
• Efficacy has a vital role, but producers look to CFIA for approved products. Provisional products need to be clarified as "temporary registration" so growers who want to test can select it.
• Producers will not sow whole farm on new productivity, but should run pilot tests to evaluate before subjecting all crops to the new product.
• Environmental conditions can change what products are required, temporary registration can allow certain products related to year to year - too wet, drought, etc.
• Reduced efficacy requirements for co-formulants and minor formula change to expedite products.
  • If new label saw "better than product before" or synergetic effects from mixing two products it should require data to support the claim.
  • There is no need to re-prove the product, but to demonstrate that it is better than the previous product.
• Level of testing - silos per regions or sites per regions. Crop and environment is highly dependant on efficacy of product.
• There must be set parameters so the product cannot have infinite perpetual registration.
• Backlog
  • There are concerns about the number of evaluators
  • Two evaluators have finished 80 files in 6 months and there are only 20 files left in the queue
  • With a full unit of four and additional policy changes the back could be eliminated.
• Statistically significant - There is a minimum 60% of trials demonstrate efficacy. It is a pass or fail per trial by trial. Many changes to multi-location analysis for overall view of efficacy and not trial by trial basis.
• Currently planning change to efficacy data and potentially phase-in to expedite the process.

Key Message

1. Reintroduce provisional registration. There could be benefits to both crop producers and the manufacturer. It provides practical feedback on the product. The label should clarify that the product is "Temporarily registered", so the producers know what they are buying.
2. Reduce efficacy requirements for co-formulants and slight formula changes. These products should not be subjected to re-prove themselves.
3. Rezone the Canadian agricultural zones. Delineate Ontario/Manitoba border and create more practical zones based on crops and growth zones.

Biosolids Regulations

• Gap analysis and defining roles and who does what
• Harmonization is the biggest challenge.
• Is there a standard for biosolids across the country? There are other reports/surveys in various provinces, additional information, but not consensus.
• Try to establish a baseline, a minimum standard
• Remove duplication of efforts
• Principles of Canadian Biosolids Partnership
• Clearing house of various information, on the same page
• Inclusiveness, make sure representation of environmental groups
• Think early, involve the right people - public, environmental groups
• Metal standards - revisit 45 years cumulative application - rationale why 45 years
• Four of the metals are biologically unavailable
• Soil composition will impact the availability of metal
• Sold versus non-sold. Clarify what this means. Don't want gaps.
• Provinces don't differentiate between sold or distributed.
• Distribution should be involved in the definition
• What about paying for taking it away? What % of products are actually being sold?
• Produce T-memo
• Municipalities need to understand what is required. One document t-memo
• Standards - tiered process
• Don't require for some products (dioxins and furans would not be required for all)
• Annual forum / conference / workshops to get the message out
• Biosolids / ongoing consultation - working groups to address biosolids issues
• How the different regulations meet?
• Definition - will happen as part of the fed-prov

Key Message

1. Regulatory coordination. Establish the baseline for the T-memo (jurisdiction, standards, science)
2. Biosolids T-memo / Definition.
3. Communicate and educate

Compliance and Enforcement - Group 1

• CFIA need to get back to more specialized inspection programs - no more than 2 programs per inspector.
  • Issue with needing extra staff at peak times
  • Many of the responsibilities would be year round
• Lawn and garden industry would support having dedicated inspectors to have non-compliant products off the shelf. There is a huge number of non-compliant lawn and garden product - which is very frustrating to those who comply.
• Managing work of inspection staff is a major issue.
• CCC working to develop framework for recognition for self-regulation.
  • First need baseline data collected by CFIA to be able to measure performance
• CFQAP would like to modify program to encourage industry participation and self-regulation
• CFQAP would like to move away from report card
• Need to reinforce to industry that if they don't self-regulate, CFIA will be.
• Also economic considerations, some industry would rather CFIA do sampling (because no cost for them)
• Some states in US are involved in a mandatory inspection program to be registered (pay service fee to state of Kentucky, their inspectors take samples). Perhaps a system like this might be a good idea, mandatory for registration
• Thinks AMPs is a good idea, although some administrative issues.
• Need to have strengthened, more focused enforcement.
• From WG, have groups of industry working on fert-pest, micronutrients, biosolids to increase compliance.
• Issues with program 6, having metals because application rates aren't always sent in with samples.
• Revision and updating AIRS, to be more informative so that compliance is ensured, but market access is not restricted due to time or misinformation or not enough information.
• Other ideas:
• US Customs broker comes to manufacturing plant and then give some type of number to expedite export to US (crossing over board)
• From lawn and garden, compliance issues with US labels for products being imported.
• To increase compliance, change requirements so that for registration of the label you would only include ingredients and not label claims.
• Suggestion that need to go to warehouse or manufacturer, not just one of many retailers.
• WG recommendation - Warning letter or meeting with big chain stores' legal council or president to ensure with their suppliers that the products need to be in compliance.
  • Would help them to go back to their vendors to help improve compliance

Key Message

1. More dedicated/specialized inspectors (reduce number of programs to 2) to ensure they have the necessary expertise and time to ensure compliance. Maintain expertise and resources in science branch (research) to ensure analytical capacity is maintained within CFIA.
2. Import product concerns including continually updating AIRS
3. Strengthened enforcement tools and options, including changing CFQAP to increase participation, use of AMPs.
   • Communication between operations and programs with industry regarding sample results.

Compliance and Enforcement - Group 2

• We have to correct enforcement issues, provide inspector training, (especially for new inspectors), e-learning (web-based), CQA compost?, AIRS (Automatic Import Reference System) and communication with CBSA (Canada Border Services Agency) to stop non-compliant products before entry.
• Is there inspector training? Takes place every 4-5 years, mostly for new inspectors, 2-3 day event with note-taking, enforcement training, content of warning letters, etc.
• Inspection manual should be clear and specific and include how to take samples, what to do. Is it available to public?
• Manual should be clearer and more specific
• Sent original package (jar or amber) for degradable products?
• Is it taken in a timely manner? How long before it is sampled and analyzed?
• Put it in plastic bag? Degradation of herbicide? Company can be deemed non-compliant, but could the cause be sampling technique? Are inspectors told/instructed to put in different package? Consistent results?
• How large is inspector staff?
  • 4 Full Time Equivalents across Canada.
  • no dedicated fertilizer inspectors.
  • Inspection Manager assigns duties (i.e. today plant health, next day fertilizer)
  • Seasons quotas determines what to do for day.
  • 14 CFIA programs, % for Feed is unknown, now Feed only inspectors, not as seasonal as fertilizer.
  • Inspector is responsible for maybe 4 programs under insolated areas.
• Act is outdated - tolerance levels are impossible to meet for dry fertilizer - risk in participating - participation is down - how much analysis done to check tolerance? Currently, measures of uncertainty (tolerances) are under review.
• What is difference between ratings of AAA à B. Storage, transport, primary ingredients issues, blender à accredited lab (compliance rates are about 79% to 84% for CFQAP).
• How are CFIA inspectors getting better analyses results then others? Working Group to review CFQAP compliance and participation.
• Consumer protection is the number one priority for CFIA.
• Non-compliant product complaint? How does it get to inspector?
  1. Open file.
  2. Sent to the Area Network Specialist (ANS).
  3. ANS directs down to the appropriate Region.
  4. Inspector goes to specific location to verify validity of complaint product (i.e. not registered).
  5. Inspector may take enforcement action or a sample.
  6. Follow-up actions are reported back to HQ in Ottawa.
• Detention - inspector fills out a form, put tag on product, process of what to do (1) Register, (2) Destroy (3) Ship it out of country. Negotiation - company and inspection staff.
• Company may take product off shelf, without having to go to detention.
• Detention more than once, (1) Elevated enforcement action and more formal training (2) prosecution - court fine
• 3 strikes policy - set procedures 1, 2, 3
• Do the results of non-compliance get back to the manufacturer?
• If product is detained, retailers are encouraged to contract manufacturer.
• CFIA should increase communication of non-compliance with manufacture, not retailer (not their fault).
• Inspector cannot go to prosecution on their own, need inspection manager.
• Awareness of food safety? What are we doing to increase awareness?
• Education and tradeshows.
• Do the Feed people know of the consumer protection program in place?
• Suggestion to encourage compliance - publish non-compliant products so public can see companies.
• What if lab is the reason? Then publicize, Maybe 3 strikes policy. A company would be unwise to not comply as it looks bad in the public eye. A company wants to save money, not lose money by putting more pesticide than necessary in a fert-pest.
• Training - Lot numbers required July 12^th.
• What if enforcement actions such as AMPs and prosecutions, or CFQAP non-compliances were published on the CFIA website?
• Do we publish all results of all programs? No.
• Results of biosolids, heavy metal, pathogen and fert-pest testing are not published.
• July 12^th AMPs come into effect for the Fertilizer Program.
• Based on severity: Minor - registration number versus registration number, Serious - pathogens in products
• Does AMPs publish minor/severe?
• If you pay in 2 weeks, reduce fine by 50%?
• Start July 12^th, may start with warning letter.
• 1^st NC - send letter
• Not a safety issue - , go back in a year
• Pathogen - go to detention
• Do we have a list of processes we do each time?
• Intention, harm (due diligence) determines enforcement action
• Matrix not been implemented yet - not to inspectors, not sure if final yet.
• Will matrix be provided to industry? Should but not in control
• Quota - Does inspector go check?
• Surveys - go to location and check what's there (i.e. 2007 wetting agents)
• If provided a list of distributors, could we go out? Yes.
• Complaint - is there a follow-up letter to say we've dealt with it.
• We say the complaint has been looked into (other data is confidential).
• Name of individual submitting complaint stays confidential.
• The US publishes which complaints are non-compliant.
• Company tries to become compliant after being published.
• All wetting agents have to be registered.
• Liquid/granular - one may be registered, one not. The one that is not is non-compliant
• CFIA would detain at retailer or distributor.
• Take sample at store, is it non-compliant for that specific lot?
• If not registered, inspector can detain whole pallet at retailer
• Inspector can ask for records, person has to help get records or else he/she is hindering the inspection.
• Is there any discipline for inspectors?
• No certification of inspectors, training is up to inspection manager
• Took seed 6 years to put in place a certification of inspectors program.
• Would instill industry and public confidence in the sampling.
• CFIA should look into certification, look at AAPFCO.

Key Message

1. Sampling procedures are well defined. Need better format in inspection manual on how to take sample, what to do, is it available to the public? Are samples being dealt with in a timely manner?
2. Unregistered products that are on the market should be detained at the distributors or higher, otherwise it may still be available at other retail locations.
3. Possible enforcement actions and publication of enforcement procedures (increase transparency).

Product Assessment and Service Delivery Standards

• Need to clear the backlog
• Need to increase the number of enquiries
• Need to address items identified in the 2002 survey and focus on
  • Developing internal procedures for file review to improve efficacy and consistency
  • Electronic Submissions
  • Website
  • Delivery standards
  • Tiered review process
• The amount of files in backlog is larger than estimated workload manageable per years
• "Trade memos" terminology does not fit the document
• Suggest: visual on website (i.e. flowchart with links to resources at various points and verbal presentations)
• E-Learning on CD about labels and submission preparation
• Use DACO type form to assist with data requirements and data supported submissions
• Use electronic forms for more basic submissions
• Minor amendments (must consider fees act) - new ways (i.e. registrant address) and notification process (i.e. move into T-memo)
• Informal working group on SDS. Send invite through ListServ and ask comments/suggestions are sent to Ben to ensure our standards can be implement by all of the industry

Key Message

1. Improve communication by improving electronic resources (i.e. website, flowchart with links to resources documents)
2. use of e-learning and other training methods to assist registrants and potential registrants to learn the process.
3. Streamlining submission by using alternate process leading to decrease service delivery standards time (i.e. tiered submissions, changes will be seen with implements of 3 year renewals and move away from static renewal date)

Enhanced Feed Ban Regulation

• Where does it fit in with CFIA's mandate
• Cost will be covered by producers
• Make sure the costs doesn't get passed on to the producers
• 3 levels of regulations
• Minimize amount of cost (efficacy, testing and safety)
• Most bone-meal manufacturers don't understand the new rules
• Misunderstanding of what is required
• The requirements for tracking is not understood
• The enforcement is required to ensure everyone is playing by the rules
• The tracking will be an issue
• Others may not change tracking and not change their bone meal sources.
• What is requirement at the tracking level?
• What level of tracking is needed?
• The retailer won't be able to track the lot number.
• Some consumers will avoid "ruminant" bone meal
• Porcine bone meal is more expensive, therefore, changes sources will be more expensive.
• Bovine meal may be a "hard sell" to consumers
• 2 piles of consumers: those that will use them and those that won't use them.
• The software is not capable of currently tracking the lot number
• Will everyone incur the costs of tracking?
• Cost for producers may rise
• Importation of products must comply with our regulations
• Major retailer cannot take the cost of tracking
• Are there alternatives for tracking that are different than recall procedures?
• Why does industry need to track more than other food?
• Public safety has been met for food product
• The producer has to be aware of what product needs to be tracked (at what level is it tracked
• I-2 bone meal producers/manufacturers/importers
• Potting soils may contain bone meal
• What happens to product
• All fertilizers will have to be coded with a lot number.
• As of July 12^th, most of fertilizer, produced by spectrum will be lot coded
• Are we going to buy porcine bone meal or bovine bone meal (spectrum?)
• Retailers are beginning to panic with regards to product on shelf (prior to July 11^th 2007)
• The costs of recall are staggering
• Would the cost of tracking offset the cost of porcine bone meal? No, not in the short term.
• Public's perception to BSE is not good
• Some people may just look at the price (less expensive)
• The running statement did not have much impact on the consumption

Key Message

1. Every player has to know the rules and play by them (enforcement)
2. Keeping the cost down to the industry as they will end up to the producer
3. Burden of tracking system will be put on the retailer and wholesaler.
4. What happens on July 13^th?

Appendix B - Table Report Book Notes from the Product-Specific Discussion

Microbial Supplements

• New technologies - industry concerned about our "forward thinkingness"
• New system or balance between new products and keeping trade secrets
• For new products and efficacy, how to evaluate for efficacy before even getting to field trials
• Process to decide how "new products" are test and proprietary information. Something formal to react to what is going to happen in the marketplace.
• Asking what kind of data you would need for a new product prior to starting any work. "If we have an idea, what would be needed to go forwards?" Efficacy, label information. We need a process for this.
• Import is an issue - complaint bringing a big batch of supplement across the board since 911.
• Concern by organic farmers by contamination of genetically modified microbials. Benefit to putting "Canadian organic approved"
• How regulate supplement and pesticides claims? How to regulate combined products?

Key messages:

1. Asking what kind of data you would need for a new product prior to starting any work. "If we have an idea, what would be needed to go forwards?" Efficacy, label information. We need a process for this.
2. Import is an issue - complaint bringing a big batch of supplement across the board since 911.
3. Concern by organic farmers by contamination of genetically modified microbials. Benefit to putting "Canadian organic approved"
4. How regulate supplement and pesticides claims? How to regulate combined products?

Micronutrients

Key messages:

1. Clear communication of the requirements for micronutrients - running the standards - currently using T-4-108 for products that require efficacy data. Need on requirements.
2. Tolerances surrounding the nutrient guaranties - viability to meet the current standards.
3. Scheduling II the products don't register, but regulate still have to be safe, efficacious, and properly labelled.
4. Turn around time, importing blends of registered micronutrients, need registration.

Speciality Fertilizers

• Concerns with hybrid guarantees (actual micronutrients versus minimum N, P, K,S, Mg, Na)
  • CFIA answer - difficult because of some micronutrients being heavy metals.
• NPK and micronutrients - tolerance is too tight
  • CFIA lab is reviewing them but we don't know if requirements are going to be wider or tighter
• Concerns - compliance issues may be due to (1) tight tolerance requirements (2) scale up factor of large amounts being blended, hard to meet requirements as opposed to blending small amounts
• Organic sources have trouble meeting consistency with NPK even more with micronutrients.
• Problem with NPK and micronutrients tolerances at the same time (blending issues)
• Maximum constant tolerances for micronutrients.

Key messages:

1. Tolerance for micronutrients in relation to speciality fertilizer.
2. Clarification of NPK guaranteed on a minimum basis and micronutrient guaranteed on actual basis
3. Requires further discussion on speciality fertilizer.

Chemical supplements

• Expiration dates not needed for some stable products (i.e. soil surfactant)
• Can provide scientific rationale
• Chemical supplements should be guaranteed on actual basis

Key messages:

1. Standardization of data requirements between Canada and the United States

N, P, K Fertilizers

• Pricing has skyrocketed in North America due to increasing demand
• CFIA sampling - level of sampling is appropriate
• Quality of products (consistency, quality) of products (prill) is a concern
  • Too crumbly, size, powdery, gets sticky in moisture
  • Powder and moisture is a problem during application
• Equipment - not CFIA policy on the quality of prill
• Tolerances - 1 to 2 % short on guarantees, lower for raw materials, no upper limit
• Consumers are concerned more with the weights of the fertilizer they are buying as opposed to blending - the guarantee.
• Ammonium nitrate - banned (voluntary withdrawal by producers). There were environmental concerns because of it.
• Imported products may not have manufacturing standards, cheaper.
• SGN requirements can be enforced when we analyze guarantee.

Key messages:

1. Quantity and consistency of primary product, the prill
   • If crumbly, powdery, you run into problems with moisture
   • Should CFIA enforce this?
2. Consumers are not that concerned with blends, the guarantees - more concerned they are getting the weight they have paid for.
3. How to ensure that imports are quality and met regulations. International standards consistent?

Waste-derived materials

• Get deeper than absolute number. Explain to public how we came up with the standards.
• Quantification with how we came up to standards
• Get different values with different tests
• Availability of contaminants - is total metal count best method
• Canada is further ahead on products like composts
• Moving products around in Canada is harder than importing in.
• Transparency in New Brunswick
• Need consistent definition
• Standards analysis issues, cost and finding someone to do it.
• Explanation of standards