Regulations Amending Certain Canadian Food Inspection Agency Regulations: SOR/2018-79

Canada Gazette, Part II, Volume 152, Number 9

Registration

April 23, 2018

SEEDS ACT

P.C. 2018-431 April 20, 2018

Her Excellency the Governor General in Council, on the recommendation of the Minister of Agriculture and Agri-Food and the Minister of Health, makes the annexed Regulations Amending Certain Canadian Food Inspection Agency Regulations, pursuant to

• (a) paragraphs 64(1)(o.1)^{footnote a} and (s) ^{footnote b} of the Health of Animals Act ^{footnote c}; and
• (b) paragraph 4(1)(d) of the Seeds Act ^{footnote d}.

Regulations Amending Certain Canadian Food Inspection Agency Regulations

Health of Animals Act

Health of Animals Regulations

1 Subsection 132(1) of the Health of Animals Regulations ^{footnote 1} is replaced by the following:

132 (1) No person shall sell, advertise or offer for sale a veterinary biologic unless it is packaged and labelled in accordance with these Regulations.

2 Section 133 of the Regulations is replaced by the following:

133 Every veterinary biologic sold, advertised or offered for sale in Canada shall carry a label.

3 (1) The portion of subsection 134(1) of the Regulations before paragraph (a) is replaced by the following:

134 (1) Subject to subsection (2), every label of a veterinary biologic sold, advertised or offered for sale in Canada shall show

(2) Paragraph 134(1)(l) of the Regulations is replaced by the following:

• (l) the words “For veterinary use only” and “Pour usage vétérinaire seulement” or other wording to the same effect; and
• (m) any cautionary information necessary to ensure the safe handling and use of the veterinary biologic.
  

(3) Subsection 134(3) of the Regulations is replaced by the following:

(3) Subject to subsection (4), the information required by subsection (1), as well as any supplemental information appearing on the label, shall be shown in both official languages, and may additionally be shown in whole or in part in any other language.

(4) A person may sell, advertise or offer for sale in Canada a veterinary biologic that is labelled in only one official language if

• (a) the Minister determines that the veterinary biologic is needed for research or emergency use; and
• (b) the person undertakes to ensure its safe storage, handling and administration.
  

4 (1) The French version of the Regulations is amended by replacing “produit vétérinaire biologique” and “produits vétérinaires biologiques” with “produit biologique vétérinaire” and “produits biologiques vétérinaires”, respectively, in the following provisions:

• (a) the definition date de péremption in section 2;
• (b) paragraphs (a), (b) and (c) of the definition données générales sur le produit in section 2;
• (c) the definition emballage in section 2;
• (d) the definition étiquette in section 2;
• (e) the definition nom assigné in section 2;
• (f) the definition permis de fabrication in section 2;
• (g) the definition produit vétérinaire biologique in section 2;
• (h) the definition publicité in section 2;
• (i) paragraph 51(c);
• (j) the portion of subsection 51.2(1) before paragraph (a);
• (k) the heading before section 120;
• (l) the definition produit vétérinaire biologique in section 120;
• (m) the heading before section 120.1;
• (n) the definition dissémination in section 120.1;
• (o) the definition méthode de confinement in section 120.1;
• (p) the definition produit vétérinaire biologique vivant et génétiquement modifié in section 120.1;
• (q) paragraph 120.2(2)(a);
• (r) clause 120.2(2)(a)(ii)(A);
• (s) clause 120.2(2)(a)(ii)(B);
• (t) paragraph 120.2(2)(b);
• (u) the portion of subsection 120.3(1) before paragraph (a);
• (v) the portion of paragraph 120.4(1)(b) before subparagraph (i);
• (w) subparagraph 120.4(1)(b)(ii);
• (x) paragraph 120.4(1)(c);
• (y) paragraph 120.4(1)(d);
• (z) paragraph 120.4(1)(e);
• (z.1) paragraph 120.4(1)(h);
• (z.2) subsection 120.5(1);
• (z.3) subparagraph 120.5(2)(a)(ii);
• (z.4) paragraph 120.5(2)(b);
• (z.5) subsection 120.6(1);
• (z.6) subsection 121(1);
• (z.7) subsection 121(1.1);
• (z.8) the portion of subsection 122(1) before paragraph (a);
• (z.9) paragraph 122(1)(h);
• (z.10) subsection 122(2);
• (z.11) subsection 122(4);
• (z.12) section 123;
• (z.13) section 124;
• (z.14) the portion of subsection 128(1) before paragraph (a);
• (z.15) paragraph 128(1)(d);
• (z.16) paragraph 128(1)(g);
• (z.17) subsection 128(4);
• (z.18) subsection 128(5);
• (z.19) subsection 128(6);
• (z.20) paragraph 129(1)(a);
• (z.21) paragraph 129(1)(b);
• (z.22) subsection 129(2);
• (z.23) section 130;
• (z.24) section 130.1;
• (z.25) section 131;
• (z.26) subsection 131.1(1);
• (z.27) subsection 131.1(2);
• (z.28) subsection 132(1);
• (z.29) the portion of subsection 132(2) before paragraph (a);
• (z.30) subsection 133(1);
• (z.31) subsection 133(2);
• (z.32) subsection 133(3);
• (z.33) the portion of subsection 134(1) before paragraph (a);
• (z.34) paragraph 134(1)(e);
• (z.35) paragraph 134(1)(k);
• (z.36) subsection 134(2);
• (z.37) section 134.1
• (z.38) subsection 135(1);
• (z.39) subsection 135(2); and
• (z.40) section 135.1

(2) The expression “(produit vétérinaire biologique)” at the end of the definition veterinary biologic in section 2 of the English version of the Regulations is replaced by the expression “(produit biologique vétérinaire)”.

(3) The expression “(produit vétérinaire biologique)” at the end of the definition veterinary biologic in section 120 of the English version of the Regulations is replaced by the expression “(produit biologique vétérinaire)”.

(4) The expression “(produit vétérinaire biologique vivant et génétiquement modifié)” at the end of the definition “live genetically modified veterinary biologic” in section 120.1 of the English version of the Regulations is replaced by the expression “(produit biologique vétérinaire vivant et génétiquement modifié)”.

Seeds Act

Seeds Regulations

5 Subsection 5(2) of the Seeds Regulations ^{footnote 2} is replaced by the following:

(2) Seed that is labelled for export is exempt from the operation of paragraph 3(1)(a) of the Act in so far as it may be exported from Canada without conforming to the requirements set out in sections 6, 7, 9, 10, 16, 18, 19, subsection 20(5) and sections 21 and 23 to 31.

6 Subsection 15(1) of the Regulations is replaced by the following:

15 (1) Subject to subsection 20(5), the labelling information that is required by these Regulations shall be shown conspicuously, legibly and indelibly in either one or both official languages.

7 (1) Subsection 20(1) of the English version of the Regulations is replaced by the following:

20 (1) In this section, pest control product has the same meaning as in section 2 of the Pest Control Products Act.

(2) Subsection 20(4) of the French version of the Regulations is replaced by the following:

(4) Lorsqu’une semence a été traitée avec un produit antiparasitaire, son emballage ou une étiquette bien visible attachée à celui-ci doit porter le symbole avertisseur et le mot-indicateur prévus par tout règlement d’application de la Loi sur les produits antiparasitaires qui indiquent la nature et le degré de risque que présente ce produit, ainsi que la déclaration suivante :

« Ne pas utiliser pour l’alimentation des personnes ou des animaux. Cette semence a été traitée avec ______ (nom commun ou chimique du produit antiparasitaire). »

(3) Section 20 of the Regulations is amended by adding the following after subsection (4):

(5) In the case of seed that is sold in Canada and that has been treated with a pest control product, the precautionary symbol and signal word referred to in subsection (4) and the following statement shall be marked on the package of the seed, or on a conspicuous label attached to the package, in both official languages:

“Do not use for food or feed. This seed has been treated with _____ (common or chemical name of pest control product). Ne pas utiliser pour l’alimentation des personnes ou des animaux. Cette semence a été traitée avec _____ (nom commun ou chimique du produit antiparasitaire).”

Coming into Force

8 These Regulations come into force on the second anniversary of the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

The Standing Joint Committee for the Scrutiny of Regulations has advised the Canadian Food Inspection Agency (CFIA) that certain labelling provisions of the Seeds Regulations and the Health of Animals Regulations must be amended. These regulations must be amended to comply with the duty imposed on the CFIA under section 26 of the Official Languages Act. Also, there is a difference in the French equivalent of the term “veterinary biologic” between the Health of Animals Regulations and the Health of Animals Act that needs to be corrected to avoid confusion.

Background

Section 26 of the Official Languages Act requires that the CFIA ensure that where regulations require labels to include information related to the health, safety or security of members of the public, the regulations must require that this information appear in both official languages.

The labelling requirements in subsection 20(4) of the Seeds Regulations as well as those in subsection 134(3) of the Health of Animals Regulations relate to the health, safety or security of members of the public. Currently, both regulations allow for information on the labels to appear in either or both official languages.

Currently, subsection 20(4) of the Seeds Regulations requires that the packaging for seed which has been treated with a pest control product be marked with a precautionary symbol and signal word (e.g. caution, danger, corrosive) to indicate the nature and degree of risk in that product. This must appear together with the statement not to use the seed for feed or food, and the common or chemical name of the pest control product, in either or both official languages. Alternatively, this information may be marked on a label attached to the package.

Presently, subsection 134(3) of the Health of Animals Regulations requires all information on the label of a veterinary biologic ^{footnote 3} imported, sold, advertised or offered for sale in Canada to be in either or both official languages. Some veterinary biologics labels are required to contain cautionary statements. These statements may indicate appropriate withdrawal periods or that a product is for veterinary use only.

In addition, the Agricultural Growth Act brought changes to the Health of Animals Act including a change to the French equivalent of the term “veterinary biologic.” This change is currently not reflected in the Health of Animals Regulations.

Objectives

The primary objective of this regulatory initiative is to amend the Seeds Regulations and the Health of Animals Regulations to meet requirements of the Official Languages Act. In addition, the French term for veterinary biologics under the Health of Animals Regulations is being updated for consistency with the Health of Animals Act.

Description

Labelling provisions in the Seeds Regulations and the Health of Animals Regulations are amended to prescribe that health and safety information be displayed in both official languages, as required by section 26 of the Official Languages Act. The new requirements will come into force after two years.

Amendments to the Seeds Regulations will require that for seed treated with a pest control product and destined for the Canadian market, the signal word (e.g. caution) and the statement not to use the seed for food or feed including the common or chemical name of the pest control product appear in both official languages [e.g. Do not use for food or feed. This seed has been treated with (common or chemical name of pest control product)].

Amendments to the Health of Animals Regulations will require that all label information on veterinary biologics commercially distributed in Canada appear in both official languages. As such, these amendments will require manufacturers to provide bilingual product information such as the assigned name, net quantity of the product in the container, and directions for use for all veterinary biologics that are for prevention, diagnosis, or treatment of infectious diseases in animals in Canada.

Other consequential amendments to the Health of Animals Regulations are also required to facilitate the implementation of the bilingual labelling requirements. Namely, these consequential amendments will

• — indicate that the proposed bilingual labelling requirement applies only to products sold, advertised or offered for sale in Canada. This will allow foreign manufacturers to ship unilingual labelled products to their designated Canadian importer on the understanding that the products will be relabelled to conform with the bilingual labelling requirements before they can be advertised or offered for sale in Canada;
• — remove unintended restrictions on the placement of labels on veterinary biologic products in subsection 133(1) of the current regulations so as to adequately reflect the definition of “label” in the Health of Animals Regulations which includes package inserts;
• — allow a person to sell, advertise or offer for sale in Canada a veterinary biologic that is labelled in only one official language if the Minister determines that the veterinary biologic is needed for research or emergency use;
• — remove the specific labelling requirement for modified live rabies vaccines because this type of vaccine is no longer being used due to safety considerations and the availability of other vaccines;
• — require bilingual labelling for any cautionary information necessary to promote the safe handling and use of the veterinary biologic; and
• — replace the term “produit vétérinaire biologique” in the French version of the regulations with the term “produit biologique vétérinaire” to reflect changes in the Health of Animals Act as a result of the enacted Agricultural Growth Act.
  

“One-for-One” Rule

The “One-for-One” Rule does not apply to these amendments, as there is no change in administrative costs to business.

Small business lens

The small business lens does not apply to these amendments, as there are insignificant costs on small businesses. The nationwide costs would be less than $1 million annually and there is no indication that small businesses would be affected disproportionately.

Consultation

The CFIA contacted stakeholders via email and in person to discuss the amendments and seek comments.

For the seed sector, the CFIA sent a survey questionnaire to affected stakeholders (the Canadian Seed Trade Association, the Canadian Seed Institute, the Canadian Seed Growers’ Association, the Pest Management Regulatory Agency and a general stakeholder list) in the spring of 2012. The survey informed them of the amendments and was used to collect data that would enable the CFIA to assess the potential impacts of this amendment on affected businesses in the seed industry as well as any impacts to consumers of the affected products. Since that time, presentations and updates have been made to various industry groups, at their annual meetings regarding progress on the regulatory amendments.

For the veterinary biologics sector, various types of group and individual notifications were released and consultations were held between March 2011 and June 2013. Provincial government officials from Quebec and New Brunswick, where French is an official language, were also consulted. Since that time, presentations and updates have been made at meetings with the Canadian Animal Health Institute, a trade association representing companies that develop, manufacture and distribute animal health products in Canada. Similar presentations and updates have also been made at semi-annual meetings of the Canadian Animal Health Products Regulatory Advisory Committee which has representation from livestock producer groups and the veterinary profession.

Updates were provided at meetings of various industry groups and associations of the seed and veterinary biologics sectors in June/July of 2017. Stakeholders are familiar with the proposed amendments, delayed coming into force and the associated timelines.

In general, stakeholders consulted had no objections to the amendments. One seed company did have concerns about the cost of making new labels. The company indicated that only a small portion of their business is carried out in Quebec and that their clients do not care if the information is in English only.

Canada’s trading partners were notified of the regulatory changes via the World Trade Organization and were provided with 60 days to make comments. The comment period ended on July 15, 2014. No comments were received.

Regulatory cooperation

These regulatory amendments are outside of the scope of regulatory cooperation with the United States and other trading partners as compliance with the Canadian Official Languages Act is a uniquely Canadian requirement.

Rationale

These regulatory amendments bring both affected regulations in line with requirements of section 26 of the Official Languages Act. The amendments provide health and safety benefits to consumers by enhancing consumer access to health, safety and security information for these products. For example, seed treated with pesticides may lead to health or safety problems if used and/or handled inappropriately while some veterinary biologics are considered as biohazardous waste after use and should be disposed of accordingly to protect human health.

In the seed industry, the affected stakeholders are the registrants of seed treatments and the sellers of treated seeds, including registered seed establishments, as well as dealers and distributors. The registrants of seed treatments supply the labels, with the health and safety information, to sellers of treated seeds (purchasers of seed treatments) and to sellers of imported treated seed. These labels are attached to packages of treated seeds by the sellers. Currently, there are 13 registrants of seed treatments for use in Canada; these 13 companies would be directly impacted insofar as they would change the labels of seeds treated with their products. The one-time costs of this change will be minimal for these companies.

In addition, some sellers of treated seed that print safety information directly on the package may also be affected. Based on the survey conducted by the CFIA, two companies reported that they will incur a one-time cost to prepare new printing masters for packaging to meet the bilingual labelling requirements.

In the veterinary biologics industry, affected stakeholders are manufacturers, wholesale-distributors and importers/exporters. There are currently 530 licensed veterinary biologic products sold in Canada, of which 37 are from Canadian manufacturers who are already fully compliant with the bilingual labelling requirement. The remaining 493 products are imported, of which only approximately 5% (25 products) currently do not have fully bilingual packaging. These approximately 25 products are imported on a small scale for niche markets, restricted use, or as newly licensed products.

There are approximately 30 Canadian importer-distributors who import veterinary biologics for resale and about 100 Canadian “end user” importers who import products for restricted use in their veterinary clinic or diagnostic laboratory. As more than 95% of affected products are already in compliance with the change, any incremental cost will only be incurred by Canadian importer-distributors of minor use or newly licensed products.

As many companies maintain a multi-year supply of pre-printed packages, the two-year delay in implementation will allow for the use of existing inventory and products with unilingual labels before the bilingual labelling requirement comes into force. The Health of Animals Regulations and the Seeds Regulations will also allow health and safety information to be attached to the package on a separate, visible label. This will enable businesses to continue to use their original packaging and add the bilingual information either as a separate, visible label or as a package insert (for the Health of Animals Regulations only) should the original package be unilingual.

A 1997 study ^{footnote 4} commissioned by the Office of the Commissioner of Official Languages on the impact of bilingual packaging and labelling on small- and medium-sized businesses in Canada determined that most businesses already provide, at their own initiative for marketing purposes, bilingual information on their products. The study concluded that while the costs are not negligible, the bilingual labelling requirement was not perceived to be a major source of difficulty, cost, or worry by small businesses in Canada.

The delayed coming into force of two years as well as clarifications being made in the Seeds Regulations and the Health of Animals Regulations related to the labelling requirements are expected to reduce compliance costs on stakeholders. Stakeholders have been apprised of these cost mitigating strategies, through meetings with Canadian Animal Health Institute and Canadian Animal Health Products Regulatory Advisory Committee for veterinary biologics and at annual stakeholder meetings for seed, and are appreciative of the strategies.

Implementation, enforcement and service standards

Compliance with the new labelling requirements for veterinary biologics will be verified through routine CFIA inspections at the Canadian manufacturer and importer level.

The CFIA’s ongoing monitoring of the seed industry includes regular and periodic label reviews of imported and domestically produced seed in the marketplace. Operational procedures will be amended to include verification of the requirement for bilingual labelling of the pest control product information.

The new labelling requirements will come into force two years from the date of registration.

Contacts

For questions pertaining to the Seeds Regulations amendment, contact

For questions pertaining to the Health of Animals Regulations amendment, contact