Interdepartmental Executive Committee on Pest Management
Le Comité interministériel exécutif sur la lutte antiparasitaire
Dir94-07
Regulatory Directive
Products Subject to the
Pest Control Products Act
and the Food and Drugs Act
The purpose of this Regulatory Directive is to define the jurisdiction of the Food and Drugs Act and the
Pest Control Products (PCP) Act in the regulation of pest control products.
Administrative guidelines have been developed to reflect the responsibilities of each department in the
application of regulatory requirements and to avoid duplication of review. Details of these administrative
guidelines are found in this Regulatory Directive.
This Directive replaces Trade Memorandum T-1-207 entitled Products, other than Antimicrobials,
subject to both the Pest Control Products Act and the Food and Drugs Act (February 14, 1980) and
Trade Memorandum T-1-214 entitled Antimicrobial Products Subject to the Pest Control Products
Act and the Food and Drugs Act (August 31, 1981).
This document is published under the authority of the Interdepartmental Executive Committee on Pest
Management which represents the departments of Agriculture and Agri-Food, Health, Environment, and
Natural Resources.
July 13, 1994
(publié aussi en français)
This bulletin is published by the Submission Management and Information Division, Pest Management
Regulatory Agency. For further information, please contact:
Publications Coordinator
Pest Management Regulatory Agency
Health Canada
2250 Riverside Drive
A.L. 6606D1
Ottawa, Ontario
K1A 0K9
Internet:
pmra_publications@hc-sc.gc.ca
www.hc-sc.gc.ca
Facsimile: (613) 736-3798
Information Service:
1-800-267-6315 or (613) 736-3799
Table of Contents
1.0
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2.0
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
3.0
Control Products Regulated Under the Authority of the
Pest Control Products Act . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
4.0
Products Regulated Under the Authority of the Food And Drugs Act . . . . . . . . . . . . . . . . . . . . . 2
5.0
The Classification Of Antimicrobial Products to be Regulated Under the Authority of the Food
And Drugs Act . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
6.0
Evaluation Of Products With Uses Subject to Both the Food and Drugs Act and the Pest
Control Products Act . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
7.0
Water Reservoirs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.0 Introduction
The following administrative guidelines have been developed to reflect the responsibilities of each
department in the application of regulatory requirements and to avoid duplication of review.
2.0 Definitions
2.1
2.2
“Drug” (as defined in Section 2 of the Food and Drugs Act) includes any substance or
mixture of substances manufactured, sold or represented for use in:
a)
the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal
physical state or the symptoms thereof, in man or animal;
b)
restoring, correcting or modifying organic functions in man or animal; or
c)
disinfection in premises in which food is manufactured, prepared or kept.
“Control Product” (as defined in Section 2 of the Pest Control Products Act) means any
product, device, organism, substance or thing that is manufactured, represented, sold or used as
a means for directly or indirectly controlling, preventing, destroying, mitigating, attracting or
repelling any pest, and includes:
a)
any compound or substance that enhances or modifies or is intended to enhance or
modify the physical or chemical characteristics of a control product to which it is added;
and
b)
any active ingredient used for the manufacture of a control product.
2.3
“Antimicrobial product” refers to any product that destroys or inhibits the growth of a
microorganism.
2.4
“Antimicrobial control product” refers to an antimicrobial product that has uses regulated by
the Pest Control Products Act.
3.0 Control Products Regulated Under the Authority of the Pest Control
Products Act
3.1
Any control product which, when applied topically1 to an animal (including fish), has as its
exclusive function the control of ectoparasites2;
1
Topical application refers to direct or indirect external application
2
Phylum Arthropoda - Arachnida, Crustacea, and Insecta (parasitic stages outside of the animal)
Regulatory Directive - Dir94-07
3.2
Products for control of microbial and other pests in the immediate environment of animals, e.g.,
premises, air, water (excluding the sanitation of drinking water), but that are not applied directly
to animals;
3.3
Control products that are used in various premises or facilities excluding:
a)
disinfectants used in premises or facilities where food is manufactured, prepared or kept
b)
disinfectants used in human and veterinary health care facilities (including instrumentation);
3.4
Control products other than antimicrobials that are used for “pest proofing” food containers;
3.5
Control products that are used for disinfection or other antimicrobial uses in domestic or
household applications, non-food industrial applications, schools, swimming pools, and in
circumstances other than those described as subject to the Food and Drugs Act and exempted
by subparagraphs 3 (a)(i), (ii), (iii), (iv) and (v) of the Pest Control Products Regulations.
Please direct inquiries relating to this section to:
Pest Management Regulatory Agency
Health Canada
A.L. 6606D1
2250 Riverside Drive
Ottawa, Ontario
K1A 0K9
4.0 Products Regulated Under the Authority of the Food And Drugs Act
4.1
Any drug or combination of drugs which, when administered to an animal (including fish),
regardless of the route of administration, has as its exclusive function the control of
endoparasites3;
4.2
Any drug or combination of drugs which, when administered to an animal (including fish), other
than by topical application (as defined in footnote 1) has as its exclusive function the control of
ectoparasites4;
4.3
Any drug or combination of drugs which, when administered to an animal (including fish),
regardless of the route of administration, has as its preponderant function the control of
endoparasites and which may also control ectoparasites4.
3
Phylum Nemathelminthes - Platyhelminthes; Phylum Protozoa; and Phylum Arthropoda - Arachnida, Crustacea and
Insecta (parasitic stages migrating or dwelling inside of the animal)
4
Phylum Arthropoda - Arachnida, Crustacea and Insecta (regardless of the parasitic stage)
2
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Please direct inquiries relating to items 4.1-4.3 of this section to:
The Director
Bureau of Veterinary Drugs
Health Canada
Main Statistics Canada Building
Tunney's Pasture
Ottawa, Ontario
K1A 0L2
4.4
Antimicrobial products regulated as disinfectants under the authority of the Food and Drugs
Act including any antimicrobial product manufactured, sold or represented for use as a
disinfectant, germicide, bactericide, virucide, fungicide or combination of these5:
a)
on environmental surfaces and other inanimate objects for the mitigation or prevention of
disease in humans or animals, in a facility used to manufacture, prepare or keep food
under the control of the manufacturing or other commercial facility, excluding
antimicrobial products intended to preserve, prevent or treat damage, spoilage or disease
on agricultural produce during its growth, harvest, transport, preservation or storage;
b)
on environmental surfaces and other inanimate objects for the mitigation or prevention of
disease in humans or animals in patient care areas of health care facilities such as
hospitals, nursing homes and medical, veterinary and dental clinics;
c)
for the sterilization and/or disinfection of medical devices.
For the appropriate contact, please refer to Section 5.0 below.
5.0 The Classification Of Antimicrobial Products to be Regulated Under the
Authority of the Food And Drugs Act
Antimicrobial products bearing use claims or application instructions associated with drug uses,
medical care and the prevention or treatment of disease, or the preservation and protection of food
during its manufacture, preparation, cooking or processing, all of which are subject to the Food and
Drugs Act and are exempted by section 3(a)(i), (iii), (iv) and (v) of the Pest Control Products
Regulations. The following illustrate some common applications or use situations:
5
5.1
Antimicrobial soaps, creams, sprays, or liquids, for direct application to humans or domestic
animals (including household pets as well as livestock).
5.2
Antimicrobial claims for surgical, medical and dental instruments, including but not limited to:
Products represented for use as sanitizers, cleaners, degreasers, detergents, polishers, mould inhibitors, etc. are also
excluded from this category
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3
a)
b)
c)
d)
e)
5.3
scalpels, cardiac catheters and plastic components of the heart/lung oxygenator;
aspirator tubes, thermometers and telescopic instruments;
face masks, operating tables and other accessory medical equipment;
gauze, bandages and similar dressings;
hospital linens, bedsheets, etc.
Antimicrobial claims for furniture, floors, walls and lavatory articles in patient care areas of
hospitals.
5.4. Food manufacturing and processing plants including but not limited to:
a)
b)
c)
d)
e)
f)
g)
5.5
bakeries
liquid beverage bottling plants
dairy industry premises (milk rooms on farms)
canneries
slaughterhouses
meat-packing plants
fish processing and packaging plants.
Areas in which food is prepared or kept, including but not limited to:
a)
b)
c)
food storehouses
butcher shops
food contact areas of restaurants, hotels or other commercial operations, including food
contact areas of hospitals and clinics.
5.6
Treatments for preserving foods.
5.7
Chemicals or devices for water purification (Refer to Section 7.0 “Water Reservoirs”)
5.8
Please direct inquiries relating to items 5.1, 5.3, 5.4 and 5.5 to:
The Director
Bureau of Non-Prescription Drugs
Health Canada
1600 Scott Street
Holland Cross
Tower B, 4th Floor
Ottawa, Ontario
K1A 1B6
4
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5.9
Please direct inquiries relating to items 5.2 and 5.7 to:
The Director General
Environmental Health Directorate
Health Canada
Tunney's Pasture
Ottawa, Ontario
K1A 0L2
5.10 Please direct inquiries relating to items 5.6 to:
The Director
Bureau of Chemical Safety
Food Directorate
Tunney's Pasture
Ottawa, Ontario
K1A 0L2
6.0 Evaluation Of Products With Uses Subject to Both the Food and Drugs Act
and the Pest Control Products Act
A considerable number of labels for antimicrobial products possess uses that render these products
subject to regulation by both the Food and Drugs Act and the Pest Control Products Act. An
example would be a disinfectant product that is represented for use in hospitals and schools. As noted
in this Directive, the directions for use in hospitals make the product subject to the Food and Drugs
Act, while the disinfection of schools is regulated by the Pest Control Products Act.
Applications received by the Plant Industry Directorate for the registration of a control product
containing uses that fall under the purview of both the PCP Act and the Food and Drugs Act will be
treated as follows:
6.1
Upon preliminary evaluation of the application, the registrant will be advised that the product
possesses label claims that fall under the purview of the Food and Drugs Act.
6.2
The registrant will be referred to the appropriate authority.
6.3
Registration will be granted only when the registrant demonstrates that the application has
satisfied the requirements of both the PCP Act and the Food and Drugs Act.
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5
In addition to clarifications relating to use areas as recorded above, the following interpretations also
apply:
6.4
A claim for the diagnosis, treatment, mitigation or prevention of disease or alteration of a normal
body function in man or animal renders a product subject to the Food and Drugs Act.
6.5
A claim for the control of an organism on an inanimate object renders a product subject to the
PCP Act unless exempted by subparagraph 3(a)(iii), (iv), or (v) of the PCP Regulations.
6.6
Where a product is a “dual-purpose insect repellent” (e.g., sunscreen/insect repellent), it will be
reviewed as outlined in this Section.
7.0 Water Reservoirs
The purpose of this section is to clarify Agriculture and Agri-Food Canada's position with respect to
water reservoirs and to describe Health Canada's responsibilities. The term “water reservoir” could
pertain to all kinds of water, including drinking water or a water supply source before it is taken up
for purification. The following definitions will be used to distinguish water reservoirs with respect to
potable water:
!
potable water supply reservoir - any body of water that may be used as a source of potable
water before it is purified for drinking purposes.
!
potable water storage reservoir - water that is stored during the purification process or after it
has been purified for human consumption.
The use of products to control a pest in a potable water supply reservoir would be subject to
the requirements of the PCP Act. The control of pests in a potable water storage reservoir
would be subject to the Food and Drugs Act (or other federal legislation that regulates
drinking water).
If you have any questions regarding this document, please contact:
Pest Management Regulatory Agency
Health Canada
A.L. 6606D1
2250 Riverside Drive
Ottawa, Ontario
K1A 0K9
Telephone: 1-800-267-6315
Facsimile: (613) 736-3798
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Regulatory Directive - Dir94-07