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Vol. 143, No. 13 — June 24, 2009

Registration

SOR/2009-176 June 11, 2009

CANADA AGRICULTURAL PRODUCTS ACT

P.C. 2009-944 June 11, 2009

Her Excellency the Governor General in Council, on the recommendation of the Minister of Agriculture and Agri-Food, pursuant to section 32 (see footnote a) of the Canada Agricultural Products Act (see footnote b), hereby makes the annexed Organic Products Regulations, 2009.

ORGANIC PRODUCTS REGULATIONS, 2009

INTERPRETATION AND APPLICATION

INTERPRETATION

1. The following definitions apply in these Regulations.

“Act” means the Canada Agricultural Products Act. (Loi)

“Agency” means the Canadian Food Inspection Agency established by section 3 of the Canadian Food Inspection Agency Act. (Agence)

“CAN/CGSB 32.310” means the most recent version of CAN/CGSB 32.310, entitled Organic Production Systems — General Principles and Management Standards. (norme CAN/ CGSB 32.310)

“CAN/CGSB 32.311” means the most recent version of CAN/CGSB 32.311, entitled Organic Production Systems — Permitted Substances List. (norme CAN/CGSB 32.311)

“conformity verification body” means an entity that

(a) has an agreement with the Agency under subsection 14(1) of the Canadian Food Inspection Agency Act to assess, recommend for accreditation and monitor certification bodies; and

(b) meets the requirements set out in ISO/IEC 17011. (organisme de vérification de la conformité)

“ISO/IEC 65” means the most recent version of ISO/IEC Guide 65 of the International Organization for Standardization, entitled General requirements for bodies operating product certification systems. (norme ISO/IEC 65)

“ISO/IEC 17011” means the most recent version of ISO/ IEC 17011 of the International Organization for Standardization, entitled Conformity assessment — General requirements for accreditation bodies accrediting conformity assessment bodies. (norme ISO/IEC 17011)

“multi-ingredient product” means a type of agricultural product composed of two or more agricultural products. (produit multi-ingrédients)

“organic product” means an agricultural product that has been certified as organic in accordance with these Regulations or that has been certified as organic under section 27. (biologique)

APPLICATION

2. These Regulations apply to food and drink intended for human consumption and food intended to feed livestock, including agricultural crops used for those purposes. They also apply to the cultivation of plants.

PART 1

VERIFICATION AND CERTIFICATION BODIES

FUNCTIONS

3. For the purposes of these Regulations, conformity verification bodies are designated by the Agency to assess, recommend for accreditation and subsequently monitor certification bodies. Accredited certification bodies are responsible for the organic certification of agricultural products and organic product packaging and labelling certification.

PREVIOUSLY ACCREDITED CERTIFICATION BODY

4. If a certification body was accredited by a conformity verification body prior to the coming into force of these Regulations, the accreditation issued by the conformity verification body shall be recognized as an accreditation issued by the Agency. The Agency shall provide the certification body with an accreditation number.

APPLICATION FOR ACCREDITATION

5. A person who wishes to be accredited as a certification body shall apply for the accreditation in writing to a conformity verification body and undergo an assessment in accordance with ISO/ IEC 17011 to verify

(a) their compliance with ISO/IEC 65;

(b) their knowledge, with respect to organic certification, and that of their employees and, as the case may be, their subcontractors;

(c) the validity of their certification methodology; and

(d) the validity of their methodology results.

ACCREDITATION

6. On the recommendation of a conformity verification body, the Agency shall accredit the applicant. The Agency shall provide the accredited certification body with an accreditation number.

REFUSAL

7. If the conformity verification body refuses to recommend the accreditation of the applicant, the conformity verification body shall send a notice to the applicant, by registered mail, stating the reasons for the decision and advising the applicant of their right to request that the Agency review the decision within 30 days after receipt of the notice. The conformity verification body shall also send a copy of the notice to the Agency.

REVIEW

8. The Agency shall, on request, review the decision referred to in section 7 and, if the Agency decides to confirm the decision, it shall send a copy of its decision with reasons, in writing, to the applicant. If it does not confirm the decision, it shall accredit the applicant and provide the applicant with an accreditation number.

SUSPENSION AND CANCELLATION

9. (1) Subject to subsection (2), on the recommendation made in a report of the conformity verification body, the Agency shall suspend the accreditation of a certification body if the certification body has not complied with any provision of the Act, these Regulations or ISO/IEC 65.

(2) No accreditation shall be suspended unless the Agency has taken the following steps:

(a) it has notified the certification body that there are grounds for suspension;

(b) it has provided the certification body with a copy of the report that specifies the grounds for suspension, the required corrective measures and the period within which those measures must be implemented to avoid suspension; and

(c) it has notified the certification body of the suspension, if the certification body has failed or is unable to implement the required corrective measures within the period specified in the report referred to in paragraph (b).

(3) If the certification body has not implemented the required corrective measures or their implementation is not possible within the period specified in the report referred to in paragraph (2)(b), the certification body may obtain from the conformity verification body an extension of the period.

(4) The suspension remains in effect until the required corrective measures are implemented by the certification body and verified by the conformity verification body or until the cancellation of the accreditation.

(5) The Agency shall cancel the accreditation if

(a) the application made under section 5 contains false or misleading information; or

(b) the certification body has not implemented the required corrective measures within 30 days following the day on which the accreditation was suspended or within any longer period allowed under subsection (3).

(6) No accreditation shall be cancelled unless the Agency has taken the following steps:

(a) it has advised the certification body of an opportunity to be heard, either orally or in writing, in respect of the cancellation, it has given the certification body that opportunity and it has rendered a decision that was unfavourable to the certification body; and

(b) it has sent a notice of the cancellation to the certification body and advised the certification body of its right to request that the Agency review the decision within 30 days after the receipt of the notice of cancellation.

SUBMISSION OF LISTS

10. In the case of a suspension or cancellation of its accreditation, the certification body shall provide the Agency, without delay, with a list of holders of certifications and a list of pending applications for certification.

PART 2

CERTIFICATION

DETERMINATION OF PERCENTAGE OF ORGANIC PRODUCTS

11. For the purpose of this Part and Part 3, the percentage of organic products contained in a multi-ingredient product shall be determined in accordance with CAN/CGSB 32.310.

APPLICATION FOR ORGANIC CERTIFICATION

12. (1) A person who wishes to obtain an organic certification for an agricultural product shall apply to a certification body, sub-ject to subsection (3), within 12 months before the day on which the product is expected to be marketed, in the form provided by the Agency and signed by the applicant.

(2) The application shall contain

(a) the name of the agricultural product;

(b) in the case of a multi-ingredient product, a statement setting out its composition and the percentage of organic products it contains;

(c) a statement naming the substances used in the production and processing of the agricultural product and describing the manner in which those substances are used; and

(d) a report setting out in detail the methods used in the production and processing of the agricultural product and the control mechanisms in place to ensure that those methods comply at all times with the requirements set out in CAN/CGSB 32.310.

(3) In the case of an initial application for an organic certification of a product set out in column 1 of Schedule 1, the application shall be filed within the time set out in column 2.

PROCEDURE FOR ORGANIC CERTIFICATION

13. (1) A certification body shall certify an agricultural product as organic if it determines, after verification, that

(a) in the case of a multi-ingredient product, at least 70% of its contents are organic and its composition complies with the requirements set out in CAN/CGSB 32.310;

(b) the substances used in the production and processing of the agricultural product are those set out in, and used in the manner described in, CAN/CGSB 32.311; and

(c) the production and processing methods used and the control mechanisms in place comply with the requirements set out in CAN/CGSB 32.310 and with the general principles respecting organic production set out in that standard.

(2) The certification body shall issue documents to the applicant confirming the organic certification of the product.

APPLICATION FOR ORGANIC PRODUCT PACKAGING AND LABELLING CERTIFICATION

14. (1) A person who wishes to package and label an organic product shall apply to a certification body, in the form provided by the Agency and signed by the applicant, for certification that the packaging and labelling are done in accordance with the requirements set out in CAN/CGSB 32.310.

(2) The application shall contain

(a) the name of the organic product packaged and labelled;

(b) a statement naming the substances used in the packaging and labelling of the organic product and describing the manner in which those substances are used; and

(c) a report setting out in detail the packaging and labelling methods used and the control mechanisms in place to ensure that those methods comply at all times with the requirements set out in CAN/CGSB 32.310.

PROCEDURE FOR ORGANIC PRODUCT PACKAGING AND LABELLING CERTIFICATION

15. (1) A certification body shall certify the packaging and labelling of an organic product if it determines, after verification, that

(a) the substances used in the packaging and labelling of the organic product are those set out in, and used in the manner described in, CAN/CGSB 32.311; and

(b) the packaging and labelling methods used and the control mechanisms in place comply with the requirements set out in CAN/CGSB 32.310 and with the general principles respecting organic production set out in that standard.

(2) The organic product packaging and labelling certification remains in effect for a period of 12 months beginning on the day on which it is granted.

PREVIOUSLY ISSUED CERTIFICATIONS

16. Any certification issued before the coming into force of these Regulations by a certification body whose accreditation is recognized under section 4 is deemed to have been issued under these Regulations.

RECORDS

17. A holder of a certification shall maintain the records referred to in CAN/CGSB 32.310.

CHANGES AFFECTING CERTIFICATION

18. A holder of a certification shall notify the certification body without delay of any change that may affect the certification and of any complaint received relating to the organic integrity of the product referred to in the certification.

SLAUGHTERING, TRANSPORTATION AND STORAGE

19. The slaughtering of organic livestock or the transportation and storage of organic livestock or an organic product shall, in order to ensure the organic integrity of the livestock or product, be conducted in accordance with the requirements set out in CAN/CGSB 32.310.

SUSPENSION AND CANCELLATION

20. (1) Subject to subsection (2), the certification body shall suspend the certification referred to in section 13 or 15 if

(a) the holder of the certification has not complied with any provision of the Act, these Regulations or the certification;

(b) in the case of a multi-ingredient product, less than 70% of its contents are organic;

(c) the substances used by the holder of the certification are other than those set out in CAN/CGSB 32.311;

(d) the agricultural product comes into contact with substances other than those set out in CAN/CGSB 32.311;

(e) the substances used by the holder of the certification are the ones set out in CAN/CGSB 32.311, but are not used in the manner described in that standard; or

(f) the production, processing, packaging and labelling methods used by the holder of the certification do not comply with the requirements set out in CAN/CGSB 32.310, or with the general principles respecting organic production set out in that standard.

(2) No certification shall be suspended unless the certification body has taken the following steps:

(a) it has notified the holder of the certification that there are grounds for suspension;

(b) it has provided the holder of the certification with a copy of a report that specifies the grounds for suspension, the required corrective measures and the period within which those measures must be implemented to avoid suspension; and

(c) it has notified the holder of the certification of the suspension, if the holder has failed or is unable to implement the required corrective measures within the period specified in the report referred to in paragraph (b).

(3) If the holder of the certification has not implemented the required corrective measures or their implementation is not possible within the period specified in the report referred to in paragraph (2)(b), the holder of the certification may obtain from the certification body an extension of the period.

(4) The suspension remains in effect until the required corrective measures are implemented by the holder of the certification and verified by the certification body or until the cancellation of the certification.

(5) The certification body shall cancel the certification if

(a) the application made under section 12 or 14 contains false or misleading information; or

(b) the holder of the certification has not implemented the required corrective measures within 30 days following the day on which the certification was suspended or within any longer period allowed under subsection (3).

(6) No certification shall be cancelled unless the certification body has taken the following steps:

(a) it has advised the holder of the certification of an opportunity to be heard, either orally or in writing, in respect of the cancellation, it has given the holder that opportunity and it has rendered a decision that was unfavourable to the holder; and

(b) it has sent a notice of the cancellation to the holder of the certification.

PART 3

LABEL

LANGUAGES

21. Any claim or statement referred to in sections 24 and 25 shall appear on the label of an organic product in English and in French or in one of those languages if, in accordance with subsection B.01.012(3), (7) or (11) of the Food and Drug Regulations, the information that is required by those Regulations to be shown on the label of the food may be shown in that language only.

LOGO

22. The logo set out in Schedule 2 is prescribed as an agricultural product legend.

USE OF THE AGRICULTURAL PRODUCT LEGEND

23. (1) No person shall affix the logo set out in Schedule 2 to a product other than an organic product.

(2) Despite subsection (1), no person shall affix the logo set out in Schedule 2 to a multi-ingredient product whose organic content is less than 95%.

LABELLING AND ADVERTISING REQUIREMENTS

24. (1) No person shall affix a label to a product, or make an advertisement for a product, that contains the words “organic”, “organically grown”, “organically raised”, “organically produced” — or similar words, including abbreviations of, symbols for and phonetic renderings of those words — unless the product is

(a) an organic product, other than an organic product that is a multi-ingredient product; or

(b) a multi-ingredient product that is an organic product and that contains at least 95% organic contents.

(2) Despite subsection (1), a multi-ingredient product that is an organic product but contains less than 95% organic contents may be labelled or advertised with the words “organic ingredients” if those words

(a) are immediately preceded with the percentage, rounded down to the nearest whole number, of the contents that are organic; and

(b) are of the same size and prominence as the preceding words, numbers, signs or symbols that indicate the applicable percentage.

(3) Despite subsection (1), a list of ingredients on a label affixed to a multi-ingredient product that is not an organic product may indicate which of the ingredients are organic.

OTHER REQUIREMENTS

25. No person shall affix a label containing the words referred to in subsection 24(1) or (2) to an organic product unless the label also contains

(a) the name of the certification body that has certified the product as organic;

(b) in the case of a multi-ingredient product, the organic contents identified as organic in its list of ingredients; and

(c) in the case of an imported product for which the agricultural product legend is used on the label, the statement “Product of” immediately preceding the name of the country of origin or the statement “Imported” in close proximity to the legend.

PART 4

INTERPROVINCIAL AND INTERNATIONAL TRADE

INTERPROVINCIAL TRADE

26. No person shall market a product as an organic product in interprovincial trade unless the product meets the requirements set out in these Regulations.

IMPORTATION

27. (1) No person shall import or market a product as an organic product in Canada unless the product

(a) is an organic product under these Regulations; or

(b) originates from a country with which the Agency has entered into an agreement or an arrangement regarding the importation and exportation of organic products and the product is certified as organic, in accordance with the agreement or the arrangement, by a certification body recognized by that country.

(2) Despite subsection (1), a product originating from a country that has not entered into an agreement or an arrangement regarding the importation and exportation of organic products may be imported or marketed in Canada as an organic product if it is certified as organic by a certification body recognized by a country referred to in paragraph (1)(b) and the certification is in accordance with the agreement or arrangement referred to in that paragraph.

28. Any person who imports a product or markets it in Canada as an organic product shall be able to demonstrate, at all times, that the product meets one of the requirements set out in section 27 and shall retain the documents attesting that the product is organic.

REPEAL

29. The Organic Products Regulations (see footnote 1) are repealed.

COMING INTO FORCE

30. These Regulations come into force on June 30, 2009.

SCHEDULE 1
(Subsection 12(3))

PRESCRIBED TIME

Item

Column 1

Agricultural Product

Column 2

Prescribed Time

1.

Maple products

15 months before the day on which the product is expected to be marketed

2.

Field crops or crops grown in greenhouses with an in-ground permanent soil system

15 months before the day on which the product is expected to be marketed

SCHEDULE 2
(Sections 22 and 23)

LOGO

Logo Canada Organic

The logo is displayed in either black with a white background (as illustrated), in black with a transparent background or in colour. If displayed in colour, the background is white or transparent, the outer and inner borders are green (Pantone no. 368), the maple leaf is red (Pantone no. 186) and the lettering is black.

REGULATORY IMPACT
ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive Summary

Issue: The Organic Products Regulations, 2006 (OPR 2006) were promulgated on December 14, 2006 with a coming into force date of December 14, 2008. Following a review of the OPR 2006, it was determined that certain elements required clarification and elaboration in order to allow the Canadian Food Inspection Agency (Agency) to implement a fair and effective regulatory framework upon its coming into force. In order to allow sufficient time for consultation with industry and Canada’s international trading partners, the coming into force date was extended to June 30, 2009. Following consultation with international and domestic stakeholders, the Organic Products Regulations, 2009 (OPR 2009) were pre-published in Part I of the Canada Gazette on February 14, 2009 with a 75-day public comment period. This publication incorporates comments received during the comment period.

Description: The OPR 2009 will form the basis of a federally regulated system for organic agriculture in Canada. The OPR 2009 will provide clarification on the scope of application, address regulatory issues resulting from the incorporation by reference of the Canadian General Standards Board’s (CGSB) “Organic Production Systems General Principles and Management Standards” (CGSB 310 Standard) and the “CGSB 32.311 Organic Production Systems Permitted Substances Lists” (PSL), strengthen the Agency’s and other federal government departments’ ability to negotiate import-export agreements with foreign governments, adjust export requirements to allow flexibility in international trade and provide for a new organic agricultural product legend (legend).

Cost-benefit statement: The OPR 2009 will support the primary policy objective of introducing a mandatory federal framework for regulating organic products. Third party service providers will continue to play an integral role in Canada’s regulated organic system. The OPR 2009 will not result in any additional administrative burden to industry above and beyond what the OPR 2006 introduced. Cost-benefit projections suggest that mandatory regulation and certification of organic products, with third party delivery, could result in an overall net benefit to Canada of $752 million.

Business and consumer impacts: The OPR 2009 will support the further development of the domestic market for organic products and will regulate the marketing of most organic products in interprovincial and international trade. The OPR 2009 will strengthen the Agency’s ability to provide protection to consumers against deceptive and misleading labelling practices and claims regarding organic products by improving the links between the requirements in the CGSB 310 Standard and the OPR 2009.

Domestic and international coordination and cooperation: On coming into force, the OPR 2009 will form the basis of a federal program for the regulation of organic products in Canada. The Canada Organic Regime (COR) is designed to build on the existing system of voluntary accreditation and certification. The OPR 2009 are consistent with regulatory provisions and standards in other jurisdictions such as the United States of America and the European Union. The provinces of British Columbia and Quebec have regulations governing organic products. The remaining provinces and territories currently rely on voluntary systems. The OPR 2009 are anticipated to support the further development of trade in organic products and will not result in overlapping mandates between the federal and provincial/territorial governments. The OPR 2009 will apply to inter-provincial and international trade, while provincial standards will apply to intra-provincial trade.

Issue

The OPR 2009 provide a framework for a federally regulated organic regime in Canada. Since their promulgation in 2006, the Agency has reviewed the OPR 2006 and determined that certain elements required clarification and elaboration. The OPR 2009 will allow the Agency to fully implement the COR and achieve the intended and expected outcomes of a federally regulated program for organic agriculture.

As there were numerous amendments to the OPR 2006, it is typical drafting convention to repeal and replace prior to the coming into force date. In order to allow sufficient time to consult with the domestic industry and Canada’s international trading partners, it was necessary to extend the coming into force date to June 30, 2009.

A number of issues were identified in the OPR 2006, which the OPR 2009 will address: (i) the scope of application; (ii) the regulatory issues resulting from the adoption of the CGSB 310 Standard and PSL into the regulatory framework; (iii) the strengthening of the Agency’s and other federal government departments’ ability to negotiate import-export agreements with foreign governments; (iv) adjusting export requirements to allow flexibility in international trade; and, (v) reducing consumer confusion through the introduction of a single legend.

Objectives

The OPR 2009 meet the original objectives which include facilitating international market access, providing protection to consumers against deceptive and misleading labelling practices through a uniform approach to organic product certification and labelling, and supporting further development of the domestic market. The OPR 2009 address the issues identified above and will add new provisions to allow the preservation of the organic nature and integrity of organic products.

The OPR 2009 are important from the perspective of advancing the implementation of Canada’s regulated organic system and avoiding a potential disruption in the trade of organic products both domestically and internationally.

An early principle used in establishing the COR was that it would be cost recoverable. While industry is already covering a significant component of the costs associated with organic certification, resources will be required to manage the national program, to interface with Certification Bodies (CBs) and Conformity Verification Bodies (CVBs), and to verify compliance and take enforcement actions when necessary. Fees may be applied in the future. Should the application of these fees be necessary, this would be done in strict adherence to the User Fees Act, a key principle of which is broad consultation with stakeholders and provincial/territorial partners.

Description

Scope of the Regulations

In the OPR 2009, a new section is included which limits the scope of their application to food and drink intended for human consumption and food intended to feed livestock, including agricultural crops used for those purposes, and also to the cultivation of plants.

In developing the scope of application of the OPR 2009, the Agency considered whether a technical standard exists for a particular commodity within the CGSB 310 Standard such that criteria for its organic certification exist. While the authority of the Canada Agricultural Products Act (CAPA) is broad enough to cover a wide range of agricultural products, the OPR 2009 narrow the scope of application to include only certain “agricultural products” which fall within the mandate of the Agency.

Neither aquaculture nor fertilizer products will be subject to the OPR 2009. Under the authority of CAPA, aquaculture products are not considered to be agricultural products and do not have a technical standard within the CGSB 310 Standard. Fertilizer products also do not have a technical standard within the CGSB 310 Standard.

Other commodities such as cosmetics, pet food, and natural health products are excluded from the scope of application of the OPR 2009. Although they are included in the CGSB 310 Standard, these products do not fall within the mandate of the Agency. Further consultations on these commodities and regulatory or legislative amendments may be required to determine their future inclusion under the OPR 2009. It may be determined that some commodities and their organic status should be governed by another government department, agency or body.

Oversight bodies and existing certification bodies

Building on the existing organic certification system, the OPR 2009 will set out the responsibilities of the two oversight bodies of Canada’s organic program: CVBs and CBs.

The OPR 2009 replace the term “accreditation body” which appears in the OPR 2006, with the term “conformity verification body” (CVB). This change in wording harmonizes the Canadian terminology with international accreditation terminology and the standards and practices of conformity verification. This change in terminology was requested by the organizations that perform this work as they assess and recommend the accreditation of the CBs to the Agency, rather than grant the accreditation.

Incorporation by reference of Standards

The OPR 2009 incorporate several third-party standards by reference. This incorporation by reference eliminates the need to reproduce the requirements of the standards word for word within the text of the Regulations and has the effect of incorporating their requirements into the OPR 2009 with the same force of law.

The incorporation by reference of these Standards is dynamic in nature, meaning that any changes made to the Standards will not necessitate an amendment to the OPR 2009; the most current version of the Standard will be incorporated by reference at any given time. The Standards are relatively stable over time and amendments flow from a lengthy consultative process. Industry will have ample time to adjust their operations to any amendments.

(i) International Organization for Standardization Standards (ISO)

In order to enhance international credibility, the fairness and effectiveness of Canada’s regulated organic system, and to ensure uniformity and consistency of assessments performed by the various Agency-designated CVBs and accredited CBs, the OPR 2009 incorporate by reference two Standards developed by the globally recognized ISO: the ISO/IEC 17011 and the ISO/IEC Guide 65.

Referencing these Standards in the OPR 2009 contributes to greater consistency in the evaluations by the Agency of CVBs, in the assessment of CBs for accreditation by CVBs, and certification of organic products.

These Standards will primarily be used by the Agency, CVBs and CBs. At the time at which these Regulations were made, the ISO/IEC 17011 Standard is available for purchase on-line at a cost of CAN/$113.00 at www.iso.org/iso/store.htm and the ISO/ IEC Guide 65 at a cost of CAN/$62.33 at www.iso.org/iso/ store.htm.

(ii) Canadian General Standards Board (CGSB) Organic Standards (Standards)

The OPR 2009 maintain the incorporation by reference of the CGSB 310 Standard.

The PSL is also incorporated by reference into the OPR 2009. The PSL sets out all of the substances permitted to be used in the production and preparation of an organic product.

Over the course of the last two years, the Committee for Organic Agriculture (COA), under the leadership of the CGSB, has undertaken the revision of the CGSB 310 Standard to ensure that the Standard will work in harmony with the OPR 2009. The revisions address regulatory issues related to the amount of discretion the Standards provided to CBs and includes new and innovative provisions for industry, as well as allowing for new permitted substances.

At the time at which these Regulations were made, both of the Standards CAN/CGSB-32.310 and CAN/CGSB-32.311 are available for purchase on-line at www.techstreet.com/cgsbgate.html for a cost of CAN/$30.00 per copy.

Accreditation — Right to review

In order to improve clarity respecting an applicant’s right to request a review by the Agency in cases where a CVB refuses to recommend accreditation, the OPR 2009 clearly confer a right upon an applicant to request a review of such a decision and prescribe a limit as to the amount of time an applicant has to make such a request. The OPR 2009 also impose a duty on a CVB to inform applicants of their right to request a review by the Agency of the CVB’s recommendation. The OPR 2009 impose an explicit duty on the Agency to perform such a review. The Agency will follow up with the CVB to discuss its recommendation and the Agency’s findings.

In cases where the Agency disagrees with a CVB’s recommendation not to accredit an applicant, and proceeds to then accredit the applicant, the Agency will not assume the role of the CVB. The affected party will be responsible for seeking out another designated CVB as a service provider.

Preserving organic integrity

An objective of the OPR 2009 is to ensure that the organic integrity of a product is not compromised in any stage of preparation. For example, there is a need to prevent the co-mingling of organic and non-organic agricultural products and to prevent the contact of organic products with substances prohibited by the PSL Standard.

In respect of an agricultural product, CAPA defines “preparation” as including: processing, slaughtering, storing, inspecting, grading, packing, assembling, pricing, marketing and labelling. A provision is included which requires that the activity of packaging and labelling of an organic product be subject to certification. While not required to be certified, the slaughtering of organic livestock, the transportation of organic products or organic livestock and the storing of organic products must be done in accordance with the Standards. This is for the preservation of the organic integrity of an organic product from the reception of the ingredients through to the end consumer.

The OPR 2009 require an organic operator applying for certification to the CB to provide information that substantiates the organic integrity of their product. The CB is responsible for determining that the information provided by an applicant is sufficient to establish the product certification at each stage of its preparation.

Certification: application, procedure and renewal

Under these Regulations, persons wishing to market an agricultural product as an organic product will need to follow the management system prescribed by the CGSB 310 and the PSL Standards as they relate to organic principles of production.

When certifying agricultural products as organic for the purposes of marketing, CBs will rely on the assessment of the operator’s management system and its compliance with the OPR 2009, CGSB 310 and the PSL Standards to issue certifications.

With the exception of activities related to packing and labelling, under the COR it is the agricultural product that is certified and not the process. The CB evaluates the operator’s plan and system in order to verify the production process used in preparing the product meets the requirements of the Standards in order to certify the product as organic. This approach flows from the Agency’s role in regulating the marketing of certain agricultural products as organic as well as the use of the legend in accordance with CAPA.

The OPR 2009 require that a person who wishes to obtain certification for an agricultural product apply within 12 months of when the agricultural product is expected to be marketed as an organic product. As such, persons wishing to obtain certification should be under the oversight of a CB for a sufficient period of time prior to the granting of certification to permit proper assessment of the operator’s management system and its compliance with the OPR 2009. The OPR 2009 establish specified periods of time for maple products, field crops and greenhouse crops with an in-ground permanent soil system. For other commodities, the length of time required for the operator to be under the supervision of a CB will be dependent upon the length of time and the complexity involved in transitioning from conventional production to organic production.

The OPR 2009 also require that organic certification be applied for annually and, in the case of packaging and labelling, renewed within 12 months after the date of granting. This is required to verify that the criteria for certification continue to be met by the holder.

Regulatory authority to suspend or cancel accreditation or certification

(i) Suspension or cancellation of accreditation

In order to provide fairness to regulated parties, the OPR 2009 clarify the process as well as define steps and roles and responsibilities in the event of a suspension or cancellation of an accreditation. This includes providing prior notice to the affected party of suspension or cancellation action and notification of the right to be heard in the case of cancellation of accreditation. The period during which a suspension will remain in effect is also stipulated.

An additional non-compliance trigger for suspension of accreditation is included in the OPR 2009. It will be possible for a CVB to recommend suspension of accreditation if a CB has not complied with any provision of the ISO/IEC Guide 65 Standard, the OPR 2009 or CAPA.

(ii) Certification — Responsibilities of certification bodies

The OPR 2009 require a CB, whose accreditation is suspended or cancelled, to provide to the Agency a list of its certificate holders and a list of applications for organic certification that are pending.

The Agency will notify affected producers with certified products that the CB, with whom they have a service contract for certification, has had its accreditation cancelled or suspended. The affected producers or operators would then select another Agency-accredited CB as a service provider. The suspension of accreditation of the CB will not affect the status of an organic certification that was issued before the suspension of the accreditation of the CB unless it was determined that the integrity of the organic product had been compromised.

(iii) Suspension and cancellation of organic certification

The OPR 2009 provide the authority to CBs to suspend or cancel an organic certification and also define the circumstances under which CBs should proceed with suspension or cancellation actions. The CBs will evaluate a certificate holder’s compliance with the OPR 2009, the product formulations to verify organic content, and the methods and manner in which the certificate holder conforms to the CGSB 310 and the PSL Standards.

The OPR 2009 build in a number of safeguards for certification holders that impose certain notification requirements on CBs before suspension or cancellation action can be pursued.

Organic certification

The OPR 2009 require that the organic content of a multi-ingredient product be calculated by the method contained in the CGSB 310 Standard. The CGSB 310 Standard specifies that only organic products may be used in determining the percentage of organic products contained in a multi-ingredient product.

Duty to inform

The OPR 2009 include a provision requiring the holder of an organic certification for an agricultural product to inform its CB of a change that affects the certification or of a complaint received by the holder about the integrity of the organic product.

International trade

Canada has an interest in both the export and import market for organic products. The language of the OPR 2006 had the potential to be interpreted as requiring all exported organic products to meet the Canadian organic standards. This may have had an impact on agreements regarding the importation and exportation of organic products between Canada and its trading partners and may have been viewed as an unnecessary barrier to trade for some exporters.

As Canada does not have the capability to meet domestic demands for organic products, seventy to eighty percent (70–80%) of organic products are imported primarily from the United States. Canada exports organic grains and other organic products to foreign markets, such as the European Union. Accordingly, it is important that, in seeking to regulate the Canadian organic industry, the Regulations provide the flexibility to facilitate international trade and to promote the development of the domestic organic sector. The OPR 2009 contain the following provisions related to international trade:

1. Importation

The OPR 2009 provides the Agency with the option of permitting imported products to enter Canada from countries whose requirements are deemed to be equivalent to those in the Regulations. The wording of this provision provides the flexibility to encompass any type of agreement respecting the import of organic products. These agreements will not limit the Agency’s ability to administer and enforce pursuant to its legal mandate.

There are three (3) scenarios under which an organic product may be imported into Canada. Since the imported product would comply with the OPR 2009, the product would be eligible to bear the legend.

(i) Product imported without an Import-Export Agreement

An organic product imported into Canada from a country where there is no import-export agreement for organic products with the Agency would have to meet the requirements of the OPR 2009, including being certified to the CGSB 310 Standard by an Agency accredited CB.

A product originating from a country that has not entered into an import-export agreement with Canada may nevertheless be imported and marketed in Canada as organic if it is certified as organic by a CB recognized by a country with which Canada has an agreement, and is certified in accordance with that agreement.

(ii) Imported product under a full or partial Import-Export Agreement

Import-export agreement that deems both the foreign country’s conformity assessment system, as well as its standards, as being equivalent to requirements of the OPR 2009 would be considered a full equivalency agreement. Under this scenario, an imported product may be certified through the foreign country’s conformity assessment system to the foreign standards and would be considered to meet the requirements of the OPR 2009.

An import-export agreement that contains exceptions would partially deem the foreign country’s conformity assessment and standards as equivalent to the Canadian requirements. If the foreign country’s conformity assessment system and its standards are deemed only partially equivalent, then the exceptions would be outlined in the agreement and the certification would have to meet the requirements of the agreement.

(iii) Imported product under an Import-Export Agreement (recognition)

Where the Agency would recognize a foreign country’s conformity assessment system as equivalent to that of Canada, but would not recognize the foreign standard, an agreement would be considered to be a recognition agreement. Under this scenario, imports may be certified through the foreign country’s conformity assessment system pursuant to the Standards.

2. Exportation

Under the OPR 2009, there is no specific requirement that exported products meet Canadian regulatory requirements. This approach has been proposed in order to address concerns that the export measures included in the OPR 2006 have the potential to be detrimental to Canadian exports. The OPR 2006 requirement for exported products to meet both the requirements of the OPR 2006 and the foreign country requirements, when these products are destined solely for export and would not enter the Canadian market, could be overly burdensome and could impose unnecessary costs. A key rationale for the development of the OPR 2009 was to ensure continued access to international markets for the Canadian organic industry, including those producers seeking to expand their export market.

(i) Canadian export-only product with no Import-Export Agreement

A product that is to be exported to a country where there is no import-export agreement signed with the Agency may be certified to the importing country’s requirements and/or the OPR 2009. These products would only be eligible to bear the legend if certified in accordance with the OPR 2009.

(ii) Canadian export-only product under Import-Export Agreement (equivalency)

Under this scenario, a product that is to be exported to a country under an import-export agreement signed with the Agency may be certified to the OPR 2009 which would be deemed as equivalent to the importing country’s requirements.

Any import-export agreements with foreign countries would only be signed after a thorough analysis of the foreign regime and only if the Agency is satisfied that the foreign regime meets the principles and objectives of the COR. The ability to enter into these agreements will provide cost advantages to consumers along with the additional choice of products available, especially in light of Canada’s high dependence on imported organic goods. Furthermore, the reciprocal nature of these agreements would benefit Canadian exporters.

Labelling provisions

Organically produced food cannot be distinguished visually from conventionally produced food and cannot necessarily be distinguished by taste; therefore, consumers rely on labels, other advertising tools for product information and certification to ensure the organic claims are true.

The OPR 2009 improve consumer protection by strengthening the rules surrounding the labelling of organic products linking the Regulations and the requirements in the CGSB 310 Standard with respect to the calculation of organic content and permitted non-organic ingredients.

(i) Bilingualism

As the OPR 2009 apply to imported products and products traded inter-provincially within Canada, it is important that organic claims be present in both official languages. In keeping with the intent of the Official Languages Act, organic claims are required to be bilingual.

(ii) Organic legend

The Agency received feedback from the Canadian organic industry requesting that either the legend not be used on imported organic products or that a revision to the appearance of the legend be made to prevent consumer confusion as to the origin of the products bearing the legend.

The OPR 2009 introduce a single legend that may be used voluntarily on organic products certified in accordance with the Regulations and having an organic content of 95% or higher. Imported products are eligible to bear the legend provided they meet Canadian requirements.

(iii) Labelling requirements

The OPR 2009 establish specific labelling requirements and permit the use of certain terms (e.g. organically grown) on organic products.

Three types of organic claims are permitted based on the organic content of a product:

(1) Single ingredient organic products and multi-ingredient organic products with an organic content greater than or equal to 95% may be labelled organic and may bear the legend. These products must be certified in accordance with the Regulations and must bear the name of the Agency-accredited CB that certified it as organic.

(2) Multi-ingredient products with an organic content of greater than 70% and less than 95% may bear the claim X% organic ingredients. These products must be certified in accordance with the Regulations and must bear the name of the Agency-accredited CB that certified it as organic under the Regulations, but may not bear the legend, nor use the claim “organic.”

(3) Multi-ingredient products with an organic content of less than 70% may not be labelled organic, with the exception that any organic product contained in it may be identified as an organic product in the list of ingredients. These products may not bear the legend.

Notwithstanding the presence or lack thereof of any other organic legends, logos or statements, consumers wishing to confirm the status of the organic claim on a product they have purchased can look for the name of the Agency-accredited CB on the packaging material and visit the Agency’s Internet site (www. inspection.gc.ca), or contact the Agency to confirm that the CB is accredited by the Agency.

(iv) Use of legend for marketing or advertising or informational purposes

Third-party use of the legend is controlled by the Agency under the legislative authority contained in the CAPA and the Canadian Food Inspection Agency Act (CFIAA). Third parties wishing to use the legend in advertising or marketing materials or for information purposes may apply to the Agency for permission. The application and granting of permission for any given third party use is administered by the Agency. The terms and conditions of a licence agreement will outline the activities for which the legend may be used and the manner of use of the legend. The application and the procedure for application is available on the Agency’s Internet site.

Record keeping

Any person who imports a product marketed in Canada as an organic product must be able to demonstrate, at all times, that the product conforms to the Regulations and must retain the documents associated with the product. The OPR 2009 require that a person demonstrate, through continuous traceability, the integrity of an organic product.

Environmental impact assessment

According to the CGSB 310 Standard, organic production is based on principles which include the protection of the environment and minimization of soil degradation and erosion, maintenance of soil fertility, maintenance of biological diversity within the system, recycling of materials and resources to the greatest extent possible, attentive care that promotes the health and meets the behavioural needs of livestock, preparation of organic products, emphasizing careful processing, and handling methods in order to maintain the organic integrity and vital qualities of the products at all stages of production, and reliance on renewable resources in locally organized agricultural systems.

Based on these principles, the OPR 2009 are not expected to affect or be the cause of potential harm to the environment.

Regulatory and non-regulatory options considered

The Government of Canada is committed to implementing a mandatory regulatory framework with a third party delivery system for Canada’s organic industry and consumers. To achieve the desired outcomes, the following options were considered:

Option 1 — Implement the OPR as promulgated in 2006

The option exists to allow the OPR 2006 to come into force on June 30, 2009. This was not recommended as certain elements of the OPR 2006 required clarification and elaboration in order to support the full implementation of a fair and effective regulatory framework upon coming into force.

Option 2 — Repeal the OPR 2006

The option to repeal the OPR 2006 and not introduce new Regulations was considered. This option was not recommended as it would not have delivered on the Government of Canada’s commitment to introduce a mandatory regulatory framework for organic products. This option could have jeopardized trade with Canada’s international trading partners. Moreover, Canada’s organic industry continued to request government oversight and a mandatory federal regime.

Option 3 — The OPR 2009

This option is the adopted course of action and addresses the identified issues, including: the scope of application; the regulatory issues resulting from the adoption of the CGSB 310 Standard and the PSL into the regulatory framework; the ability of the Agency and other federal departments to negotiate import and export agreements for organic products and adjusting export requirements to allow flexibility in international trade; and reducing consumer confusion through the introduction of a single legend.

Conclusion

The chosen approach addresses the identified issues and makes implementation of a federal regulatory framework for organic products feasible. This is consistent with the policy decisions adopted in 2006 to introduce federal regulations for organic products with third party delivery. The OPR 2009 support the further development of the domestic market for organic products, introduce a framework for the preservation of the organic nature and integrity of organic products and regulate the marketing of organic products in inter-provincial and international trade. The Regulations also offer additional protection to consumers against deceptive and misleading labelling practices and claims regarding organic products.

Benefits and costs

The Agency conducted in 2005 a detailed cost-benefit analysis of the effects of introducing regulations. The study, Cost-Benefit Analysis of the Effects ofFederal Regulation for Organic Products, examined the economic impacts and the full range of social and economic effects of the Regulations on Canadian society. The study considered the quantified impacts on growers and producers, and on the sectors that support the organic industry (processors, wholesalers, retailers, exporters, accreditation bodies (CVBs), and certification bodies (CBs). Qualitative impacts on consumers, the Canadian public at large, and the federal and provincial governments were also considered.

The original study has been recently updated with the inclusion of a discount rate of 8% and the use of 4% and 10% for the sensitivity analysis. Another update has been made on the time period. Whereas the original study assumed each option as “once for ever,” in the update, a time period of 50 years has been considered instead.

In the original study, the option of a status quo led to an overall loss of $490 million stated in 2005 dollars (2005$). The bulk of that negative impact falls on growers and producers (-$752 million) and on exporters (-$28 million). Although these previous results were based on a discount rate of 6.8%, the outcome at 8% would remain a net loss.

The original study also examined the option of mandatory regulation and certification, but delivered solely by the federal government. That option was found less favourable than the option of implementing the Regulations due to the cost increase associated with transition to and implementation by the federal government. These costs outweigh the savings achieved due to the phasing out of third-party accreditation agencies (CVBs) and certification bodies (CBs).

The option of implementing the Regulations results in net cumulative benefit of $752 million, using a discount rate of 8%. Retailers and Consumers are the largest beneficiaries with net benefits of $279 million and $211 million, respectively. However, excluding governments, all stakeholder groups benefit as none is left worse off relative to the current situation (i.e. status quo) as evidenced by the net benefit distribution as follows:

— growers and producers, $110 million;

— processors, $11 million;

— wholesale services, $7 million;

— exporters, $8 million;

— import services, $153 million;

— retail, $279 million;

— consumers/society, $211 million;

— conformity verification bodies (accreditation agencies), less than $0.001 million;

— certification bodies, less than $0.1 million;

— government, -$27 million

These results are summarized in the following table that reports the discounted (at 8%) costs and benefits. All the figures are in 2005$M.

Summary Table

Cost-Benefit Statement

Base Year: 2006

Final Year: 2055

Total (Net Present Value)

Average Annual (2006-2055)

A. Quantified Impacts $
(Discounted at 8%, 2005$M)

Benefits

       

Growers and producers

0.29

0.92

345.66

6.91

Processors

 

0.18

67.19

1.34

Wholesale services

 

0.12

46.27

0.93

Export/buying services

0.58

0.01

8.16

0.16

Import services

 

2.68

1,016.15

20.32

Retail

 

5.48

2,071.27

41.43

Consumers/society

 

0.56

210.91

4.22

Total Benefits

0.9

10.0

3,765.6

75.3

Costs

       

Growers and producers

 

0.63

235.62

4.71

Processors

 

0.15

56.01

1.12

Wholesale services

 

0.10

38.99

0.78

Export/buying services

       

Import services

 

2.27

863.38

17.27

Retail

 

4.74

1,792.13

35.84

Consumers/society

       

Government

2.12

0.05

27.20

0.54

Total Costs

2.1

7.9

3,013.3

60.3

Net Benefits

       

Growers and producers

0.29

0.29

110.05

2.20

Processors

 

0.03

11.18

0.22

Wholesale services

 

0.02

7.28

0.15

Export/buying services

0.58

0.01

8.16

0.16

Import services

 

0.40

152.76

3.06

Retail

 

0.74

279.14

5.58

Consumers/society

 

0.56

210.91

4.22

Government

-2.12

-0.05

-27.20

-0.54

Total Net Benefits

-1.3

2.0

752.3

15.0

B. Qualitative Impacts (not assessed)

— Reduction in soil erosion

— Reduction in nitrate leaching

— Reduction in greenhouse gas emission

— Maintenance and return levels of biodiversity

— Increased land area dedicated to organic farming as resulting from increases in organic products consumption

Due to their relative small magnitude, data for accreditation agencies (CVB) and certification bodies (CB) are not picked up in the above table. Furthermore, due to data limitations, not all benefits and costs could be quantified as indicated in the section B of the above table. Similarly, implementation of option 3 will result in increases in the personnel of the Agency, incremental and ongoing expenditures for market access activities and various expenses incurred by provincial governments with respect to their provincial accreditation bodies.

Further details for all the stakeholders as well for all the options are contained in the full report, which can be accessed at: www.inspection.gc.ca/english/fssa/orgbio/coana/ coanae.shtml. The recommended option, referred to as Option 2 in the report — federal regulation with accreditation and certification by a third party — is equivalent to the Option 3 that is contained in this RIAS.

Rationale

Mandatory regulation and certification of organic products, with third party delivery, is expected to result in overall net benefit to Canada of $752 million. Additionally, all stakeholder groups share in the benefit as none is left worse off relative to the current situation.

The Canadian organic industry has continued to request a federal regulatory system to support the continued development of the industry. The OPR 2009 offer protection to consumers through a uniform approach to organic certification and labelling. More specifically, these Regulations will address the issues identified above and are important from the perspective of advancing implementation of the COR.

The Provinces of Quebec and British Columbia have regulations in place governing organic production systems. Through consultation with the respective provinces, the Agency has considered British Columbia’s and Quebec’s regulatory requirements to avoid creating any technical barriers to trade between the provincial and federal standards.

Consultation

Industry

Since the publication of the OPR in December 2006, the Agency has worked closely with organic industry groups on the development of the Regulations and to address the outstanding issues that directly impact the Agency’s ability to implement and the industry’s ability to comply with the Regulations. The Agency has maintained close communication with stakeholders and industry groups by engaging in bi-weekly conference calls to discuss issues and the progress of the Regulations in detail.

Since December 2006, the COA has undertaken a major revision to the CGSB 310 and PSL Standards. The COA is composed of representatives of relevant interest groups, including organic producers, consumers, importers, and other users, retailers, government (federal/provincial), educational institutions, technical, professional and research organizations (organic stakeholders). Both the COA and the CGSB support the incorporation of this Standard into the Regulations.

In collaboration with the Organic Federation of Canada, the Agency performed cross-country consultations with industry stakeholders on the proposed OPR 2009 in early September 2008. Town hall meetings were held with direct interaction between Agency officials and organic industry stakeholders, including representatives from provincial government, organic operators, retailers, importers, CVBs and CBs. The town hall information sessions were held in Burnaby, British Columbia; Edmonton, Alberta; Regina, Saskatchewan; Winnipeg, Manitoba; Guelph, Ontario; Québec, Quebec; and, Moncton, New Brunswick.

The industry has indicated support for the OPR 2009 and is aware of the intent. However, some concerns over the following issues have been expressed.

1) Scope

Some sectors of the industry (aquaculture, personal care products, textiles, pet food and cosmetics) and stakeholders in Quebec expressed concern that a number of organic products which are regulated at the provincial level are not included in the scope of application of OPR 2009. Further consultation on these commodities will be required to determine their future inclusion under the OPR 2009 or whether their organic status should be governed by another government department, agency or body.

2) Access to imported products

Some stakeholders expressed concern over the introduction of provisions which permit the Agency to enter into import-export agreements that will allow for the import of products from equivalent foreign organic regulatory regimes, because they perceive that these products might not need to meet Canadian Standards.

It is the Agency’s intention to facilitate the importation of agricultural products that are organic in nature while ensuring their organic integrity meets the intent of the general principles of organic production. A thorough analysis of the foreign regime would be conducted and the Agency would have to be satisfied that the foreign regime meets the principles and objectives of the COR before foreign agricultural products may be marketed in Canada as organic.

3) Readiness for the coming into force date and compliance and enforcement

The state of readiness varies across stakeholders for the implementation of the OPR 2009. Some industry stakeholders would like additional time, while others would prefer immediate implementation. The Agency recognizes that it is important to have a smooth transition from the existing voluntary regime to the mandatory regulatory framework. As such, agricultural products certified as organic by an accredited CB are accepted as “organic” under these OPR 2009 upon the coming into force date.

To support a smooth transition, the Agency has also developed a “Stream of Commerce/Enforcement and Compliance Policy” (Stream of Commerce Policy) where a temporary compliance and enforcement approach would be in place for a period 24 months. This will apply to both domestic and imported products.

4) Certification of exports

Industry expressed a variety of opinions on whether or not exported organic products should be subject to the OPR 2009. Some stakeholders support the removal of the requirement for exported organic products to meet the requirements of the OPR 2009. They believe that the export measures included in the OPR 2006 have the potential to be detrimental to Canadian exports. Requiring organic exports to meet both the Canadian requirements and the requirements of the foreign country, when these products are destined solely for export and will not enter the Canadian market, could be overly burdensome and could impose unnecessary costs.

Other stakeholders wanted the export provision contained in the OPR 2006 to be maintained. Those supporting the inclusion of a requirement for export certification believed it to be necessary to preserve the reputation of Canadian organic products in foreign markets and fear that, without it, the integrity of organic products grown in Canada could be jeopardized.

In order to address the concerns of those opposed to the removal of the export provisions, a teleconference was held by the Agency with representatives of Agriculture and Agri-Food Canada (AAFC), the Department of Foreign Affairs and International Trade (DFAIT) and industry stakeholders to explain the rationale for the policy decision and answer any questions from industry participants. Over 40 stakeholders participated in the teleconference.

5) Design of the legend

Concern was expressed about the potential for consumer confusion resulting from the three legends contained in the OPR 2006.

The Agency carried out focus group testing through an on-line survey to solicit industry response to proposals regarding a new legend for certified organic products. Participants in the survey included members of the Organic Value Chain Round Table (OVCRT), whose membership is drawn from a wide cross section of the Canadian organic sector including producers, processors, distributors, retailers and others. Seventy-two respondents provided comments on the design. Strong support for a single revised legend was expressed.

Interdepartmental

On August 12, 2008, Agency officials met with Canada Border Services Agency’s (CBSA) Food, Plant and Animal Unit and their Commercial Operations Section to introduce and discuss the then proposed Regulations. Since there are no specific Harmonized System Tariff Codes to distinguish them, organic products are not readily distinguishable from other imported agricultural products; as such, import declaration and/or documentation required by CBSA continues to be required. The OPR 2009 should not result in any policy or operational changes for the CBSA.

The Agency has also consulted with officials from DFAIT and AAFC in the development of the Regulations. Both departments had opportunity to review the Regulations and provided substantive comments focusing on trade-related provisions.

The Government of Canada provided official World Trade Organization (WTO) notification to Canada’s international trading partners to advise them of the then proposed OPR 2009 and to provide the opportunity to comment. No official comments were received.

Summaries of the consultations are available on the Agency’s Internet site (www.inspection.gc.ca).

Pre-publication results

On February 14, 2009, the Agency pre-published the OPR 2009 in the Canada Gazette, Part I, for a 75-day public comment period. During the pre-publication period, the Agency received approximately 150 submissions. The Agency has reviewed and considered these comments. As a result of comments received, the Agency concluded that several sections of the OPR 2009 required amendment for clarification purposes and improved understanding. These amendments do not change the original intent of the Regulations. In addition, this “pre-publication results” section has been included in the RIAS in an effort to further improve understanding of the OPR 2009.

Comments received fall into five key categories:

1. Scope and organic integrity

Comments received requested confirmation as to whether specific products or commodities, including cosmetics, natural health products, pet food and textiles, fall within the scope of the OPR 2009. A detailed explanation of the scope of the OPR 2009 is provided in the description section of this RIAS. Specific questions included whether water, Christmas trees and flowers are included in the scope. Water will not be covered under the scope of the OPR 2009 but Christmas trees and flowers are included.

Comments were received concerning slaughtering and clarification was requested as to whether the activities of slaughtering, transportation and storage of organic livestock or an organic product are exempt from the OPR 2009. These activities are not required to be certified; however, they are required to be conducted in a manner that ensure the organic integrity is maintained pursuant to the requirements set out in the CGSB 310 Standard.

Under the authority of CAPA, the OPR 2009 regulate preparation but do not regulate production. Organic integrity is defined in the CGSB 310 Standard as “the maintenance of the inherent organic qualities of a product from the reception of ingredients through to the end consumer.”

During the development of the CGSB Standard, the question of which preparation activities should be subject to certification and which should not be certified but should be required to demonstrate that organic integrity is maintained was brought before the COA. The COA analysed preparation activities including slaughtering and made recommendations as to which should be incorporated into the OPR 2009.

2. Accreditation and certification

Comments were received concerning the requirement for CBs to become ISO/IEC Guide 65 compliant. The OPR 2006 was criticized for the lack of specific criteria for accreditation of CBs. As consistency and uniformity are important elements in the functioning of a fair and effective regulatory scheme, the two ISO Standards, which are internationally recognized, third-party standards, have been incorporated to ensure greater consistency in the evaluations performed by the CVBs.

The Agency recognizes that some CBs are not currently ISO compliant and that some producers may be trading organic products inter-provincially which have been certified by a CB that does not meet the criteria to become accredited by the Agency. Compliance with the ISO Standards is necessary to ensure consistency of certifications and the international credibility of the certification system in Canada. It is the Agency’s intention to provide sufficient time for these CBs and operators to come into compliance with the OPR 2009, without interruption to trade through the Stream of Commerce policy.

Requests for clarification were received concerning the application for organic certification. Schedule 1 outlines the requirement for the initial application of the commodities listed. For maple products, greenhouse, and field crops, the initial application is required 15 months in advance. This is not in contradiction with the CGSB 310 Standard which requires a 12-month period of supervision by a CB before the granting of certification. The additional three months provided by the Schedule is for the initial application only and is intended to allow CBs some flexibility in responding to applicants, taking into account the growing season of these commodities. Field crops or crops grown in greenhouses with an in-ground permanent soil system, include all crops except those grown in containers in greenhouses. If an agricultural product is grown in a container, in a greenhouse, the length of time required to apply for initial certification is not subject to Schedule I. Guidance on this can be found in the CGSB 310 Standard. Subsection 13(1) requires that an operator apply for certification within 12 months and requires that application for certification be completed annually.

Questions were received concerning whether or not the OPR 2009 would allow for group certification. Pursuant to the CAPA, an individual, a corporation, an association or organization can make an application for certification under the OPR 2009.

3. Labelling and legend

Comments were received seeking clarification on the specific labelling requirements for multi-ingredient products pursuant to section 25 of the OPR 2009. The Agency received questions concerning the labelling of products with less than 70% organic ingredients. The intent of this section is to specify permitted organic claims for products that are certified in accordance with the OPR 2009. This includes both single-ingredient products and multi-ingredient products with an organic content of 70% or more. A multi-ingredient product with an organic content of less than 70% cannot be certified as organic under the Regulations. Multi-ingredient organic products containing 70–95% organic ingredients may be labelled as containing X% organic ingredients. The CGSB 310 Standard provides the method for calculating the percentage of organic products contained in a multi-ingredient product.

Comments were received which requested that labelling claims be adjusted to allow for such claims as “made with organic XXX” similar to permitted claims in the United States or the European Union. It is not uncommon for permitted labelling requirements to vary between countries. The primary goal of the OPR 2009 is to protect consumers and prevent consumer confusion. It is the Agency’s position that a claim such as “made with organic XXX” is vague and has the potential to mislead consumers as to the actual organic content of the product. Accordingly, no change to the OPR 2009 has been made in this regard.

The pre-published regulations contained a provision requiring that only ingredients which were not multi-ingredient products could be used in the calculation of a product’s organic content. This provision was a duplication of a requirement contained in the CGSB 310 Standard; the Agency received numerous comments indicating confusion as a result of this duplication. Following a review of this requirement, it was determined it was unnecessary in the regulatory text as it is required by the CGSB 310 Standard; it has therefore been removed from the Regulations.

The Agency received many comments opposing the word “Regime” on the product legend. Some considered this term to have negative connotations, while others indicated that the word is commonly used to describe a diet plan. The positioning of the text was also of concern. The Agency has amended the legend to address these concerns.

Comments were also received with respect to the maple leaf symbol in the legend and the potential for consumer confusion as to the product’s origin. To avoid consumer confusion, labelling requirements specify that the name of the country of origin or the statement “imported” appear in close proximity to the legend. Some comments were received from industry that the requirement to include this statement in close proximity to the legend is redundant as other legislation already requires products to identify country of origin and/or whether they are imported on the label. In order to avoid consumer confusion as to the origin of the product, this requirement has been maintained.

The Agency received comments suggesting that the printing of the legend should be permitted on a transparent background to accommodate for transparent packaging. It was suggested that this would result in cost savings as it would reduce the number of colours required for printing. The OPR 2009 have been amended accordingly.

4. Trade

During the consultation period, the Agency received several comments pertaining to agreements regarding the importation and exportation of organic products, the introduction of subsection 29(2), and changes to the export provisions.

With respect to agreements regarding the importation and exportation of organic products, some concern was expressed that imports under an importation/exportation agreement would not be required to meet the Canadian Standard. It was explained that this would only be permitted after the Government of Canada had done a thorough analysis of the foreign country’s organic system and deemed it equivalent to the Canadian System. As Canada does not yet have the domestic capacity to meet domestic demand for organic products, this provision would allow consumers and processors access to the needed supply of imported organic products to meet demand. Furthermore, the reciprocal nature of these agreements would also benefit Canadian exporters as the intent is to allow Canadian producers to certify to the Canadian Standard and by doing so meet the importing country’s requirements.

The Agency also received comments concerning organic products originating from a country that does not have an importation/exportation agreement with Canada. In most cases where there is no agreement, products must meet the Canadian requirements to be imported into Canada. However, organic products originating from a country with which Canada does not have an agreement may be certified by a country with whom Canada does have an agreement and may be imported into Canada. These products will be required to be certified in accordance with the agreement which will respect the principles of the CGSB 310 Standard. Concerns were raised during the comment period about the Agency’s ability to monitor these CBs operating in third countries. An integral part to the establishment of these agreements is a thorough review of both country’s certification systems to verify equivalent controls are in place. This would include CBs operating in third countries, who would be subject to the same criteria and monitoring as CBs operating within the country with whom Canada has the agreement.

The Agency received comments concerning the lack of requirements for products destined solely for export markets. Industry remains divided on the necessity of export requirements; trade associations and exporters continue to support their removal, while other groups continue to lobby for their inclusion. It is the Government of Canada’s position that requiring producers who produce product solely for export to meet the requirements of the Standards in addition to the requirements of the importing country would be overly burdensome and could be detrimental to trade.

The Standards have been developed for our climatic regions and unique growing conditions; this does not preclude the possibility that other national organic standards, while different, are just as rigorous or appropriate for their regions. The Government of Canada does not believe that this will provide an opportunity for exporters to misrepresent conventional products as organic products in international markets, but that it will simply provide exporters the flexibility to meet the demands of their international consumers by certifying to just the importing country’s requirements without adding the additional cost of certifying to the Canadian Standard. However, exporters are required to certify to the Canadian Standard if they wish to access the Canadian market. The purpose of the OPR 2009 is to provide protection to Canadian consumers against misleading or deceptive labelling practices, to support further development of the domestic organic agriculture product market and to facilitate international market access. By providing exporters with this flexibility, the Government of Canada believes that these objectives have been met.

5. Transition and stream of commerce

During the public comment period, the Agency received a number of inquiries related to transition and implementation of the OPR 2009.

The transition to OPR 2009 requirements is being managed through the recognition of previously accredited CBs and existing certifications. Implementation of the OPR 2009 and their compliance and enforcement are being managed through the Stream of Commerce policy. This approach will allow regulated parties who have previously obtained certifications to other organic standards (e.g. Québec Organic Standard, COABC, the U.S. NOP as well as other organic standards both domestic and international) to be accepted as being in compliance with the OPR 2009. This recognition will apply only to certifications issued by accredited CBs before the coming into force of the OPR 2009 and only until the annual renewal of certification is required.

Comments were received relating to the Stream of Commerce policy, inquiring as to whether the policy amounted to an exemption and if the policy applied to both domestic and international organic products. The Stream of Commerce policy is not an exemption but is intended to facilitate compliance with the OPR 2009 within a reasonable time frame of two years. This policy applies equally to domestic and imported products. During this time frame, the Agency will primarily enforce the OPR 2009 through an educational approach.

Implementation and enforcement

While the OPR 2006 provided for a two-year transition period for implementation, the OPR 2009 require compliance upon the coming into force date of June 30, 2009. As consumer protection is one of the primary objectives of the OPR 2009, an additional transition period could significantly impact the benefits consumers will derive from the implementation of these Regulations.

Some producers have requested additional time to adapt their systems to the CGSB 310 and PSL Standards and the mandatory framework; however, many Canadian-based operators are already being certified voluntarily to organic standards and want the Regulations to be in force.

The Agency recognizes that it is important to have a smooth transition from the existing voluntary regime to the mandatory regulatory framework. As such, agricultural products certified as organic by an accredited CB, before the coming into force of the OPR 2009, are accepted as “organic” under these Regulations upon the coming into force date. In addition, a CB accredited by a designated CVB prior to the coming into force of the OPR 2009 is considered to be accredited under the OPR 2009. This approach allows CBs to continue providing certification services to operators without interruption and will avoid a surge of requests for certification.

As outlined in the Stream of Commerce policy, the Agency will implement temporary compliance and enforcement measures which will be in place for a period of 24 months. During this period, educational activities and minimum enforcement guidelines will be used, where the operator will be advised of non-compliance issues, may be requested to make corrections, and will be encouraged to develop a plan outlining how and when deviations or non-compliances will be corrected. The Agency will implement more stringent enforcement activities after this initial period.

The Agency will verify compliance and enforce the Regulations in accordance with its statutory authorities, including those found in the CFIAA and CAPA. Compliance and enforcement activities will include audits of CVBs and CBs for compliance with regulatory requirements, label reviews, product verification and responding to consumer complaints through onsite inspections, when required.

This approach manages the transition by balancing the need to have controls in place to correct non-compliance and provide protection to consumers, while supporting continued trade and development of the organic industry.

Service standards

The Agency has a limited service delivery role in this program as the COR incorporate a third-party service delivery system for organic certification services. Service standards will apply to both imported and domestic products. Service standards will be part of the import-export agreements. Service standards for the activities within the COR are outlined as follows:

(a) Agreements with CVBs

The Agency will review for adequacy the information supplied by an entity for initial application and will acknowledge receipt within 5 business days after reception of the application.

The application and accompanying documents will be reviewed by the Agency for completeness within 15 business days of receipt. The Agency will assess the entity’s system once the application is complete. The Agency will send the evaluation report within 30 business days of completion of the assessment.

The Agency will sign the agreement within two months of the recommendation, subject to the parties consenting to the terms and conditions of the agreement.

(b) Accreditation of CBs

A CVB will be responsible for assessing and recommending an applicant for accreditation by the Agency. The length of time to complete this process and make the decision to recommend accreditation may vary depending on the completeness of the application and records, as well as the number of files the CVB is currently working on; in most cases it will be completed within 9 to 12 months.

A CVB will be responsible for providing notification of its accreditation recommendation decision to the Agency within 30 business days of reaching that decision.

The Agency will issue an accreditation number to the applicant no later than 14 business days after receiving a CVB’s recommendation for accreditation.

(c) Certification

First time certification: Service Standards will vary depending on the length of time required by the CGSB 310 Standard to transition from conventional production to organic production. Once the requirements of the CGSB 310 Standard and the PSL Standard are met, the inspection and certification process will take between 12 weeks and 16 weeks. Factors that could contribute to time delays include, but are not limited to: company location, completeness of organic plan, and the ability to demonstrate compliance at the time of inspection.

Certification renewal: Organic certification will be required to be renewed on an annual basis. For renewal, the inspection and certification process could take between 8 to 12 weeks.

(d) Appeals and complaints

The Agency’s response time for acknowledging an applicant’s request for a review of the CVB’s decision to not recommend accreditation of the applicant will be no later than 15 business days from the receipt of the request.

The Agency’s decision relative to the accreditation review will be sent to the applicant no later than 10 business days after the hearing is concluded.

The Agency’s response time for initiating follow-up to complaints regarding the organic integrity of an agricultural product will be 5 business days after having received the complaint.

(e)  Third-party use of the legend

The Agency’s response time to an application for third-party use of the legend will be within 7 business days from the receipt of application.

Performance measurement and evaluation

To measure and evaluate the effectiveness of the Regulations towards attaining the objectives as stated in this RIAS, the Agency will undertake to collect, analyse and evaluate performance based on the following key indicators.

(i)  Objective: To protect Canadian consumers and the marketplace from unfair practices

Agricultural products marketed in Canada will be required to meet the requirements of the Regulations to be marketed as organic. Regulating the use of the legend is anticipated to reduce consumer confusion with respect to the assortment of organic claims and certification marks currently existing in the marketplace. With the legend, consumers will have greater assurance that the agricultural products they are purchasing meet a defined standard, and that false and misleading claims will be deterred. This will be measured through the annual collection and analysis of the number and nature of complaints received by the Agency from consumers, organic industry stakeholders and other government departments and agencies; and, through the examination of the results of surveys and other studies of consumer trends relative to the purchase and consumption of organic products in Canada, if any are conducted and information becomes available.

The effectiveness of the Regulations in protecting the marketplace from unfair labelling practices will be measured through the annual collection and analysis of the number and nature of labelling or marking violations resulting from label verification activities. Additionally, the number of certifications that are renewed, suspended or cancelled will be monitored and may indicate compliance trends.

(ii) Objective: A fair and effective regulatory regime

A mandatory federal standard with effective enforcement will reduce confusion and provide quality assurance to consumers and traders, supporting the development of the domestic organic industry. The expected result is a level playing field for all organic products marketed in Canada as all products, including imports, will be subject to the Canadian requirements.

To determine the fairness and effectiveness of the COR, the Agency will annually compile and analyze the number and nature of complaints about unfair trade, and track any market reports making note of any growth or decline in the market for organic products. Additionally, information on the increase or decrease in the size of organic operations and in the number of certified operators in Canada will be collected annually and analyzed to ascertain the potential impact of the Regulations on the size and/or growth of the organic sector.

(iii) Objective: Improved international trade in organic products

Having a federal regulatory framework in place for organic products creates an environment in which Canada may negotiate import-export agreements with foreign trading partners. Canadian importers and consumers will have year-round access to certified organic products and entry to foreign markets will be facilitated for Canadian exporters as a result of recognition of the Canadian system. Improved international market access could be measured annually through the number of agreements with foreign countries.

Effectiveness of import-export agreements will be measured through monitoring and enforcement. The progress of the Regulations towards meeting these stated objectives will be reported annually in the Agency’s Departmental Performance Report.

Contact

Michel Saumur
National Manager
Canada Organic Office
Agrifood Division
Meat, Agrifood and Seafood Safety Directorate
Policy and Programs Branch
Canadian Food Inspection Agency
1400 Merivale Road, T1-4-142
Ottawa, Ontario
K1A 0Y9
Telephone: 613-773-6218
Fax: 613-773-6282
Email: OPR.RPB@inspection.gc.ca

Footnote a
S.C. 2001, c. 4, s. 64

Footnote b
R.S., c. 20 (4th Supp.)

Footnote 1
SOR/2006-338