Canada Gazette

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act, hereby makes the annexed Regulations Amending the Food and Drug Regulations (1356 — Disinfectants).

1. Subsection C.01A.001(1) of the Food and Drug Regulations (see footnote 1) is amended by adding the following in alphabetical order:

"antimicrobial agent" means a drug that is capable of destroying pathogenic micro-organisms and that is labelled as being for use in the disinfection of environmental surfaces or medical devices, as defined in the Medical Devices Regulations, that

(a) are not invasive devices as defined in those Regulations; and

(b) are intended to come into contact with intact skin only. (agent antimicrobien)

2. Subsection C.01A.002(1) of the Regulations is amended by striking out the word "and" at the end of paragraph (c), by adding the word "and" at the end of paragraph (d) and by adding the following after paragraph (d):

(e) fabricating, packaging/labelling, testing, distributing, and importing of antimicrobial agents.

3. The Regulations are amended by adding the following after section C.02.002:

C.02.002.1 This Division does not apply to fabricating, packaging/labelling, testing, storing and importing of antimicrobial agents.

4. These Regulations come into force on the day on which they are registered.

This amendment to the Food and Drug Regulations (the Regulations) exempts antimicrobial agents from requirements respecting Good Manufacturing Practices (GMP) and establishment licensing while still regulating them as drugs under the Food and Drugs Act (FDA) and the Regulations. This means that products meeting the definition of an "antimicrobial agent" will no longer have to comply with the requirements of establishment licensing (Part C, Division 1A) or GMP (Part C, Division 2) of the Regulations.

Antimicrobial agents are a type of lower-risk disinfectant drug. An antimicrobial agent is defined as a drug capable of destroying pathogenic micro-organisms and that is labelled as being for use in the disinfection of environmental surfaces or medical devices, that are not invasive devices as defined in the Medical Devices Regulations, and that are intended to come into contact with intact skin only.

With this amendment, all higher risk disinfectant drug products, which do not meet the definition of "antimicrobial agent", such as contact lens disinfectants, chemosterilants and high level disinfectants used to sterilize invasive devices or devices used for circulation, reintroduction of a body fluid or for introduction in a body cavity, will continue to be subject to the existing GMP and establishment licensing regulations.

Upon this amendment, fabricators, packagers/labellers, distributors, importers and testers of antimicrobial agents will still be required to meet the requirements of section 8 of the FDA (prohibition on selling drugs manufactured under unsanitary conditions or that are adulterated). To support compliance, a new standard has been made available, which is entitled "Standard for the fabrication, control and distribution of antimicrobial agents for use on environmental surfaces and certain medical devices". Compliance with this standard will be voluntary but will be considered sufficient to meet the requirements of section 8 of the FDA.

This amendment recognizes the need for government to provide an appropriate level of regulation to maximize the safety of antimicrobial agents available to Canadians without adding an undue regulatory burden to industry. It is intended to streamline the regulatory framework in matters of product safety for lower risk antimicrobial agents.

A regulatory amendment to the Pest Control Products Regulations (PCPR) was published in the Canada Gazette, Part II, on September 12, 2001 to substantially reduce the overlap in jurisdiction between the Pest Control Products Act (PCPA) and the FDA for disinfectant products. That amendment reduced regulatory duplication by exempting certain disinfectants used to prevent human and animal disease from the PCPA and consolidating them under the FDA.

However, regulation of antimicrobial agents under the FDA makes them subject to all requirements of the FDA and associated regulations, including establishment licensing and GMP. Given that antimicrobial agents are used in a different manner than other drugs used in or on the body, a risk-based approach does not support the high level of regulatory scrutiny which would result if the GMP and establishment licensing requirements were to be applied. Since these types of products had not previously been subject to comparable requirements under the PCPA, this means an added burden to industry with a less than proportional increase in safety for Canadians.

As a result of consultations held in December, 1999, Health Canada decided to pursue exemption of these products from the establishment licensing and GMP regulations while continuing to regulate them under the FDA and the Regulations.

Health Canada has worked closely with stakeholders to develop the "Standard for the fabrication, control and distribution of antimicrobial agents for use on environmental surfaces and non-critical medical devices", which was implemented January 1, 2003. The controls laid out in this standard are directly targeted to and appropriate for the antimicrobial agents in question. Feedback received thus far by Health Canada from stakeholders has indicated general satisfaction with the standard.

The Notice of Intent pre-published in the Canada Gazette, Part I, on August 1, 2001 requested input from interested stakeholders on the development of a new regulatory framework to ensure the safety, efficacy and quality of lower risk antimicrobial agents, and announced the development of an amendment to exempt these products from divisions 1A and 2 of the Regulations. One comment was received. It was favourable.

Pre-publication of this regulatory amendment in the Canada Gazette, Part I, on May 22, 2004, resulted in three comments from stakeholders. These comments were also favourable.

This amendment applies only to a defined group of lower risk antimicrobial agents. Higher risk disinfectants, which do not meet the definition of "antimicrobial agent", will continue to be subject to the current regulations regarding GMP and establishment licensing.

Significant consideration has been given to the best option regarding the regulation of antimicrobial agents. One option was to enforce the requirements of establishment licensing (Part C, Division 1A) and GMP (Part C, Division 2) of the Regulations. However, given the relatively low risk associated with these products, Health Canada deemed this approach to be an overly rigid requirement without a commensurate increase in product safety. Recognizing that these types of products had not previously been subject to comparable requirements under the PCPA, this means an added burden on industry, possibly affecting competitiveness, while providing little additional assurance of product safety to Canadians. The most effective regulatory mechanism is to maintain the requirement for antimicrobial agents to comply with section 8 of the FDA, and to exempt them from the requirements of establishment licensing and GMP, while providing a standard as guidance for compliance.

This amendment will help provide Canadians with ready access to antimicrobial agents that are safe, effective, and of high quality while at the same time ensuring that an appropriately high level of scrutiny is maintained for higher risk disinfectants.

In a competitive market, costs placed on industry to comply with the regulatory requirements would eventually be passed on to the consumer. With this amendment, the consumer will benefit from having ready access to these products without undue pressure on prices.

Industry will benefit from the revised regulatory framework by having clear and appropriate expectations articulated in the aforementioned manufacturing standard, to assist in producing safer products. As the standard is available to everyone, consumer confidence will also be enhanced.

There may be some costs associated with coming into compliance with the new standard. However, fewer costs are anticipated under the current proposal than if establishment licensing and GMP requirements were applied. For example, industry will not be incurring cost recovery expenses associated with the Drug Establishment Licensing Fees. However, the Authority to Sell Drugs Fees will still apply.

With this amendment, Health Canada will be responsive to the needs of industry while fulfilling its mandate to maintain and improve the health and safety of Canadians. Costs associated with continued administration of the FDA and compliance and enforcement related to antimicrobial agents will be borne by Health Canada. However, having clear expectations laid out in the new standard will reduce costs by increasing efficiency and will free limited resources for higher risk activities. Also, there are fewer costs associated with enforcing a set of requirements that is less rigid than the establishment licensing and GMP requirements.

It is expected that this amendment will be of significant benefit to all stakeholders, with the overall benefits outweighing the costs. This regulatory regime constitutes an appropriate level of oversight for lower risk antimicrobial agents and is a reasonable balance in terms of product safety while not imposing an undue burden on industry.

Extensive consultations related to the regulation of disinfectant products have been held over the course of the development of the broader regulatory framework. The issue of exemption of antimicrobial agents from divisions 1A and 2 was thoroughly discussed in 1999-2000, in particular in relation to the new standard, which was developed by Health Canada collaboratively with stakeholders. The exemption was announced in the Notice of Intent pre-published in the Canada Gazette, Part I, on August 1, 2001. It was also referenced in the Regulatory Impact Analysis Statement in the Canada Gazette, Part II, on September 12, 2001, that accompanied the Regulations Amending the Pest Control Products Regulations. Pre-publication of this regulatory amendment in the Canada Gazette, Part I, on May 22, 2004, resulted in three comments from stakeholders. These comments were also favourable.

Upon this amendment coming into force, fabricators, packagers/labellers, distributors, importers and testers of antimicrobial agents will continue to be expected to comply with the FDA and the Regulations. The new standard entitled "Standard for the fabrication, control and distribution of antimicrobial agents for use on environmental surfaces and non-critical medical devices" will provide guidance to industry and Health Canada will consider compliance with that standard sufficient to meet section 8 of the FDA.

In addition, Health Canada will continue to monitor compliance of antimicrobial agents with the FDA and will investigate complaints as appropriate in accordance with risk management principles.

Policy and Strategic Planning Division
Health Products and Food Branch Inspectorate
11 Holland Avenue, 2nd Floor
Address Locator 3002C
Ottawa, Ontario
K1A 0K9
E-mail: Insp-pol@hc-sc.gc.ca