Regulatory Directive: Canadian Label Improvement Program for Pesticides Used on Companion Animals

22 February 2002
ISBN: 0-662-31774-2
Cat. No.: H113-3/2002-1E
(DIR2002-01)

The purpose of this document is to outline the Canadian Label Improvement Program for pesticides used on companion animals. The Canadian Label Improvement Program is intended to reduce the potential for misuse of these pesticide products, thereby protecting animal and human health.

This document replaces Regulatory Proposal PRO2001-01, Canadian Label Improvement Program for Pesticides Used on Companion Animals, published for public comment in February, 2001. Comments received were taken into consideration for this Regulatory Directive.

Table of Contents

• 1.0 Background
• 2.0 Label Amendments
  • 2.1 Type of Companion Animal
  • 2.2 Reapplication Frequency
  • 2.3 Rate and Method of Application
  • 2.4 Minimum Age of Animals
  • 2.5 Sick, Aged, Pregnant or Nursing Animals and Animals Under Drug or Pesticide Treatment
  • 2.6 Precautionary Statements
  • 2.7 Protective Measures
  • 2.8 First Aid Statements
  • 2.9 Cholinesterase Inhibitors
  • 2.10 Environmental Hazard Statements
  • 2.11 Packaging and Labelling
  • 2.12 Non-Pesticidal Uses
  • 2.13 Multi-Use Products
  • 2.14 Sanitation Statement
  • 2.15 Resistance Issue
• 3.0 Implementation of the Label Improvement Program
• 4.0 Guidelines for Companion Animal Safety Studies to be Submitted in Support of Registration
• List of abbreviations
• Appendix I Model Label
• Appendix II Model Label for Spray - Cholinesterase Inhibitor
• Appendix III Model Label for Collar - Cholinesterase Inhibitor

1.0 Background

On October 1, 1996, the Environmental protection Agency (EPA) in the United States (U.S.) issued Pesticide Regulation (PR) Notice 96-6 to all manufacturers, formulators, producers and registrants of pesticide products registered in the U.S., outlining amendments to pesticide product labels of products used on domestic pets. The new labelling requirements resulted from the numerous reports received by the EPA of adverse reactions arising from misapplication of pesticide products registered for use on dogs and cats. Registrants in the U.S. had until October 1, 1998 to effect changes on their pesticide product labels of products used on domestic pets (herein referred to as companion animals).

Due to concerns raised in the U.S., the PMRA initiated a review of all labels of registered pesticides used on companion animals. In addition to reviewing whether Canadian labels included the amendments outlined in PR Notice 96-6, the PMRA also reviewed each of the labels for the presence of first aid, precaution, toxicology, and safety information. In summary, the review of over 250 Canadian labels revealed numerous deficiencies.

Based on the information gathered by the PMRA, and in line with harmonization efforts with the EPA, the PMRA proposed a label improvement program aimed at reducing the potential for misuse of pesticides used on companion animals and at safeguarding animal and human health. This label improvement program was published as Regulatory Proposal PRO2001-01 by the PMRA in February 2001. A number of interested parties responded with detailed comments. These comments were considered when this regulatory directive was being developed.

This directive addresses pesticides that are dermally applied to companion animals. Products that are administered to animals via other routes such as by mouth or to the eye are regulated as veterinary medicines and are not subject to this directive (refer to Regulatory Directive DIR94-07 "Products Subject to the Pest Control Products Act and the Food and Drugs Act" for clarification). For this directive, companion animals are considered to include all domestic animals typically considered as pets but it is recognized that most companion animal pesticides are specific to dogs and cats.

To assist applicants and registrants to make the amendments to their product labels or to devise new labels, specific statements have been outlined in this document and sample labels have been included in the appendices to act as an aid or template in the development of new or revised labels.

2.0 Label Amendments

Labels for all end-use pesticides registered for use on companion animals should be amended to include the following types of statements, as necessary, in addition to statements currently required on those labels:

2.1 Type of Companion Animal

Clearly indicate the type of companion animal, e.g., cat or dog, for which the specific product is registered for use. The statement below should be inserted on the principal display panel directly under the directions to "Read the label before using."

Where study data or reports of adverse effects demonstrate a sensitivity of a type of animal or a specific breed of animal to the product, the following statement should be placed directly under the "For use only on (dogs, ...)" statement on the principal display panel as well as under the "Directions for use" section.

An example of this differential sensitivity involves permethrin use on cats. Owing to metabolic differences, cats are sensitive to high doses of permethrin resulting in severe toxicosis and death. Both the PMRA and the EPA have received reports of adverse effects of permethrin in cats. In addition to the label statements indicated above regarding sensitive species, the following additional label measures should be included for products containing ≥ 45% permethrin:

The statement "Toxic to cats. Cats that actively groom or engage in close physical contact with recently treated dogs may be at risk of harm." should appear under the "Precautions: Pets" section.

Products containing <45% permethrin will be considered on a case-by-case basis.

Similar measures should be followed in any other situations of known sensitivity.

The addition of a graphic (circle with slash superimposed over a depiction of a cat), preferably on the principal display panel, is encouraged by the PMRA as a means of visually reinforcing the written warning.

2.2 Reapplication Frequency

Efficacy and safety data in companion animals are necessary in determining the limitations on reapplication. Clearly indicate under the "Directions for use" heading, the minimum safe interval between applications. (Note:this interval must not be shorter than that which would result in acceptable efficacy). The reapplication statement should be product specific and be followed by the statement: "treatment must only be repeated if pest problem reoccurs". The reapplication statement could be one of the following:

1. "Do not reapply product for XX." (Insert appropriate number of days, weeks, months.)
2. "Replace this (e.g., collar) no more than once every XX." (Insert appropriate number of days, weeks, months.)
3. "Do not use this (e.g., spray) more often than once every XX." (Insert appropriate number of days, weeks, months.)
4. "Do not repeat treatment for XX." (Insert appropriate number of days, weeks, months.)
   
   In addition, for products that may be used prophylactically to prevent pest infestations (e.g., spot-on treatments, collars), statements should be included that take into account the re-application intervals required to achieve the expected efficacy of the products. These statements, which should always be accompanied by one of (a), (b), (c) or (d), could be one of the following:
5. "Reapply every XX for continual pest control in situations where there is an ongoing risk of pest infestation." (Insert appropriate number of days, weeks, months.)
6. "Repeat every XX for continual pest control in situations where there is an ongoing risk of pest infestation." (Insert appropriate number of days, weeks, months.)

2.3 Rate and Method of Application

To avoid excessive or ineffective use, the amount of product to be applied should be indicated as clearly as possible under the "Directions for use" heading. In certain circumstances, the quantity of product used can be expressed per animal (e.g., one collar/animal). For some products, general terms can be used to express the amount of product to be applied (e.g. spraying until the hair is damp - not wet, applying a shampoo until body is covered with lather). Presumably, efficacy and safety data would have been generated under similar conditions with animals representative of all weight ranges and hair coat lengths. Where size or weight of the animal is critical to determine the dosage, the product should be packaged for specific weight ranges and labelled with appropriate weight ranges as well as a size descriptor, e.g., for small, medium, large or extra-large dogs. With this latter approach, the application rate can also be expressed per animal. A less preferable option is to package the product so that it can be used on any size of animal, and to express the quantity of product to be applied per kilogram body weight of animal.

Owing to the recent popularity of orally-administered anti-flea medication, case reports have been received by the PMRA involving oral administration of pesticides intended for dermal application. To address this issue, the following statement should be included under the "Directions for use" heading for labels of solutions, liquids, concentrates and drops to be dermally applied:

To mitigate potential exposure to the applicator, bystanders and immediate environment, the following statement should be included under the "Directions for use" heading for labels of sprays/mists and powders/dusts:

2.4 Minimum Age of Animals

Clearly indicate under the "Directions for use" heading, the minimum age of animal that specific product can be used on. The following statement should be included on every product label:

The minimum age may not be less than 12 weeks unless acceptable companion animal safety and efficacy data are submitted to the PMRA to support the product's use on younger animals.

2.5 Sick, Aged, Pregnant or Nursing Animals and Animals Under Drug or Pesticide Treatment

The following statement should be included on every label under the "Directions for use" heading:

Note: The applicant/registrant should either adopt the statement above or submit scientific data to support the removal of all or part of this statement.

2.6 Precautionary Statements

All products must have a "Precautions" section on the product label. Under the "Precautions" heading, separate "Humans" and "Pets" headings should be included that outline specific precautionary statements relevant to that pesticide.

In addition, the statement "Avoid contact with pets until dry" should be placed in the "Precautions" section of the following domestic class product types:

• sprays and mists
• foams and mousses
• solutions, liquids and concentrates
• shampoos

All domestic and commercial class products should include a handwash statement under the "Precautions" section, such as "After handling or applying, wash hands (or any other skin that came into contact with the product) with soap and water."

2.7 Protective Measures

The use of rubber gloves should be included in the "Precautions" section of the following domestic class product types:

• sprays and mists
• foams and mousses
• solutions, liquids and concentrates

The use of chemical-resistant gloves should be included in the "Precautions" section of the following commercial class product types:

• sprays and mists
• foams and mousses
• solutions, liquids and concentrates

Protective gloves are not advocated on the labels of shampoos for practical reasons; pesticidal shampoo is apt to reach the interior of gloves due to the nature of the task and consequently gloves are unlikely to greatly reduce pesticide exposure.

2.8 First Aid Statements

All products should have a "First aid" section on the product label. Under the "First aid" heading, separate "Humans" and "Pets" headings should be included that outline specific first aid statements relevant to that pesticide.

In addition, the following statement should be included on every label under the "First Aid: pets" heading:

In the case of a collar, the following statement should be adopted:

Specific information on symptoms of poisoning in humans or pets should be provided under the heading of "Toxicological Information" as per the Registration Handbook.

2.9 Cholinesterase Inhibitors

If the product contains one or more active ingredients that are known cholinesterase inhibitors, then a "Toxicology Information" section outlining appropriate directions must be included on the product label. This section should include, but not be limited to, the following statement:

"This product contains a pesticide that is a cholinesterase inhibitor."

In addition, the following statement should be included under the "Precautions" heading:

2.10 Environmental Hazard Statements

The following standard environmental statements should be included under the "Precautions" heading for sprays, mists, dust and powders. These statements would not apply to shampoos, soaps, drops or collars.

2.11 Packaging and Labelling

In the case of insecticidal pet collars or spot-on treatments that may be packaged in multiple units within an outer package that bears the product label, all aspects of a product label should be repeated on the inner packaging (i.e., label of the individual unit). Deviations from this practice should be discussed with the PMRA on a case-by-case basis.

It is important that users have information available on areas such as first aid, reapplication frequency and disposal even after the product has been applied. For products with long-term pesticidal activity (e.g., insecticidal collars), the following statement should be included under the "Directions for use":

2.12 Non-Pesticidal Uses

To eliminate unnecessary exposure to pesticides, products should not be used other than for their intended purpose. For products which have both pesticidal as well as non-pesticidal purposes, such as shampoo/flea control combination products, the following statement should be included under the "Directions for use" heading:

Similar statements should be included on any other pesticide product with additional non-pesticidal uses e.g., skin conditioner/flea control combination products.

2.13 Multi-Use Products

A multi-use pesticidal product is a product that, as outlined on the label, can be used for a wide variety of pesticidal purposes. For example, some domestic class products are registered for use as a space spray, for use on ornamental and vegetable plants, as well as for use on companion animals. These multi-use products often have limited labelling instructions with reference to use on companion animals, since the primary usage is, for example, for plant insecticidal purposes.

To ensure the health and well-being of humans and companion animals, the PMRA will not be accepting new submissions to register new products or to amend existing multi-use products that have a combination of plant and animal uses outlined on the label. Submissions that are currently in the system will be considered on a case-by-case basis, but will likely be returned to the applicant.

2.14 Sanitation Statement

To ensure that any attempts to control ectoparasites on pets are not limited to treating the pet alone, the following statements must be included:

2.15 Resistance Issue

To deal effectively with potential resistance issues, the following statement should be included under the "Directions for use" heading for pest control products:

3.0 Implementation of the Label Improvement Program

There will be a 60-day phase-in period from the date of publication of this directive which is noted on the front page of this document. Those applications that were received before the publication date, and which were still under review at that time, will be reviewed pursuant to the procedures in effect immediately preceding the publication date. Those applications received within the phase-in period will be reviewed in the same manner. Any such application that qualifies for registration, which is not a temporary registration, will be granted a registration valid until December 31, 2004. Every registrant shall have amended its label by December 31, 2004 so that the label complies with this directive.

On and after the sixty-first day following the publication date the Label Improvement Program will apply to any new application or application for amendment.

Registrants having a registration which was granted before the publication date and which has an associated expiry date later than December 31, 2004 are nevertheless required to comply with the Label Improvement Program by December 31, 2004.

Applications to amend the label for label improvement only (Category C submission) must be made by December 31, 2003 (at least 12 months in advance of December 31, 2004). If data are to be submitted, e.g., to support use of product on animals less than 12 weeks of age, applications to amend the label must be made by June 1, 2003 (18 months in advance of December 31, 2004) as they will be processed as Category B submissions. Similarly, any application to amend the label beyond the details outlined in the Label Improvement Program will be processed as a Category B submission. For multi-use products that are currently registered, registrants must make a submission application to delete either the companion animal use or alternatively all other use patterns from the label and, where required, make a new submission for a new product (i.e., split the current registration into two registrations). The label should comply with the Label Improvement Program by December 31, 2004.

4.0 Guidelines for Companion Animal Safety Studies to be Submitted in Support of Registration

The PMRA requires registrants to submit animal safety studies relevant to their particular product (DACO 4.2.10 for studies with technical grade active ingredient or DACO 4.6.10 for studies with end-use product, Use Site Category No. 24). Registrants should refer to the 1998 EPA Health Effects Test Guideline "OPPTS 870.7200 Companion Animal Safety" (see www.epa.gov/docs/OPPTS_Harmonized/870_Health_Effects_Test_Guidelines/Series/ 870-7200.pdf). This document offers guidance with respect to animal safety testing and data collection specifically relating to products used on cats and dogs. Companion animal safety information or adequate scientific waivers will be required for new active ingredients, new formulations and for major changes to registered products (e.g., change in formulation type or significant increase in active ingredient concentration).

List of abbreviations

EPA

Environmental Protection Agency

PCP

pest control products

PMRA

Pest Management Regulatory Agency

PR

Pesticide Regulation

U.S.

United States

Appendix I Model Label

Principal Display Panel

Product Name

Insecticidal Shampoo to Kill Fleas and Ticks on Dogs

Domestic

Read the label before using

For use only on dogs

Do not use on cats or kittens

Keep out of reach of children

Precautionary symbols and signal words

Guarantee: (Common chemical name of active ingredient) X%

Reg. No.: XXXXX PCP Act

Net Contents: 250 g

Company Name
Street Address
City, Province
Postal Code

Secondary Display Panel

Directions for use: Do not administer by mouth. Do not use on cats or kittens. Shake bottle well before using. Wet dog thoroughly with warm water. Apply shampoo and rub shampoo into coat beginning at the head and working backward until entire body is covered (approximately XX mL/kg). Pay special attention to neck, hindquarters, areas under legs, around the tail and between toes. Do not treat eyes, face or genitals of the pet. For difficult infestations, allow the lather to remain for 3-5 minutes. Rinse thoroughly to remove all traces of shampoo on the dog's coat. Do not use on dogs under 12 weeks of age. Consult a veterinarian before using on sick, aged, pregnant or nursing animals or animals receiving drug or other pesticide treatment. Do not use this shampoo more often than once every XX weeks or months. Treatment must be repeated only if the pest problem reoccurs. Do not use solely as a shampoo when there is no pest problem.

For effective flea and tick control, treatment of the pet should be combined with sanitation of any area used by the pet. Vacuum floors, carpets and furniture (discard vacuum bag after use) and wash the pet's bedding, living quarters and surrounding areas. If pest problems persist, an insecticidal treatment of the premises may be required. A veterinarian should be consulted when flea infestation continues to be a problem on the pet.

Precautions

Humans: Keep out of reach of children. Harmful if swallowed or absorbed through skin. May irritate eyes. Avoid contact with mouth, eyes, skin and clothing. After handling or applying, wash hands (or any other skin that came into contact with the product) with soap and water. Avoid contact with pet until dry. Avoid product contact with food, food utensils or places where food is prepared or stored.

Pets: Toxic to cats. Cats that actively groom or engage in close physical contact with recently treated dogs may be at risk of harm. Harmful if swallowed. Rinse the dog thoroughly with water to remove all traces of shampoo. Avoid contact with dog's mouth, face, eyes and genitals. Do NOT allow dog to lick the suds from the coat or to ingest any of the shampoo.

First Aid

Humans: If swallowed, induce/do not induce (specify) vomiting. Obtain medical attention or call a poison control centre immediately. If on skin, wash affected areas with soap and water. If in eyes, flush eyes with plenty of water. If skin or eye irritation persists, obtain medical attention.

Pets: Sensitivities may occur after using any pesticide for companion animals. If signs of sensitivity occur, bathe your pet with mild soap and rinse with large amounts of water. If signs continue, consult a veterinarian immediately.

Take container, label, or product name and P.C.P. Registration Number with you when seeking medical or veterinary attention.

Toxicology Information: as appropriate

Storage: Store container at room temperature.

Disposal: Do not reuse empty container. Wrap and dispose of empty container with household garbage.

Appendix II Model Label for Spray - Cholinesterase Inhibitor

Principal Display

Panel Product Name

Insecticidal Spray to Kill Fleas and Ticks on Dogs and Cats

Domestic

Read the label before using

For use only on dogs and cats

Keep out of reach of children

Precautionary symbols and signal words

Guarantee: (Common chemical name of active ingredient) X%

Reg. No.: XXXXX PCP Act

Net Contents: 250 g

Company Name
Street Address
City, Province
Postal Code

Secondary Display Panel

Directions for use: Use only in a well-ventilated area, preferably outdoors. Shake well before using. Hold container in upright position and spray the animal from a distance of 20-30 cm. Spray the entire body of the pet, beginning at the tail and working towards the head. Do not spray animal's face, eyes or genitals. As you spray, fluff the hair of the pet. Only spray until the hair is damp -- not wet. Spray ticks directly. Pay special attention to neck, hindquarters, areas under legs, around the tail and between toes. Do not use on dogs or cats under 12 weeks of age. Consult a veterinarian before using on sick, aged, pregnant or nursing animals or animals receiving drug or other pesticide treatment. Do not use this product at the same time or within 30 days before or after treatment with, or exposure to, other cholinesterase-inhibiting drugs, pesticides or chemicals. Do not use this spray more often than once every XX weeks or months. Treatment must be repeated only if the pest problem persists or reoccurs.

For effective flea and tick control, treatment of the pet should be combined with sanitation of any area used by the pet. Vacuum floors, carpets and furniture (discard vacuum bag after use) and wash the pet's bedding, living quarters and surrounding areas. If pest problems persist, an insecticidal treatment of the premises may be required. A veterinarian should be consulted when flea infestation continues to be a problem on the pet.

Precautions

Physical and chemical hazards: Caution Flammable: Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture or incinerate container even when empty. Do not store at a room temperature over XX degrees Celsius. Keep away from open flames or sparks.

Humans: Keep out of reach of children. Harmful if swallowed, inhaled or absorbed through skin. May irritate eyes, nose and throat. Avoid contact with mouth, eyes, skin and clothing. Avoid breathing fumes or vapours. Wear rubber gloves during application of this product. Avoid contact with pet until dry. After handling or applying, wash hands (or any other skin that came into contact with the product) with soap and water. Avoid product contact with food, food utensils or places where food is prepared or stored.

Pets: Harmful if swallowed or inhaled. May irritate eyes, nose and throat. Avoid direct spray of dog's or cat's mouth, face, eyes and genitals.

Toxic to fish and other aquatic life. Cover fish aquaria in vicinity of treatment area. Toxic to birds.

First Aid

Humans: If swallowed, do not induce vomiting. Obtain medical attention or call a poison control centre immediately. If on skin, wash affected areas with soap and water. If in eyes, flush eyes with plenty of water. If skin or eye irritation persists, obtain medical attention. If inhaled, move the victim to a well ventilated area. Apply artificial respiration if indicated. Seek medical attention.

Pets: Sensitivities may occur after using ANY pesticide for pets. If signs of sensitivity occur bathe your pet with mild soap and rinse with large amounts of water. If signs continue, consult a veterinarian immediately.

Take container, label, or product name and P.C.P. Registration Number with you when seeking medical or veterinary attention.

Toxicology Information: This product contains a pesticide that is a cholinesterase inhibitor (an anti-cholinesterase compound). Symptoms of human poisoning may include headache, weakness, sweating, blurred vision, nausea and diarrhea. Obtain medical attention or call a poison control centre at once. Atropine is antidotal. Acute symptoms of overdosage in dogs and cats include diarrhea, salivation, vomiting, muscular tremors and weakness. Contact a veterinarian immediately. Contains a petroleum distillate.

Storage: Store container in a cool area away from heat and open flames.

Disposal: Do not reuse empty container. Wrap and dispose of empty container in household garbage.

Appendix III Model Label for Collar - Cholinesterase Inhibitor

Principal Display Panel

Product Name

Insecticidal Flea and Tick Collar for Dogs and Cats

Domestic

Read the label before using

For use only on dogs and cats

Keep out of reach of children

Precautionary symbols and signal words

Guarantee: (Common chemical name of active ingredient) X%

Reg. No.: XXXXX PCP Act

Net Contents: XX g

Company Name
Street Address
City, Province
Postal Code

Secondary Display Panel

Directions for use: Do not remove the collar from its package until ready to use. Remove the collar from the package, unroll and stretch to activate the pesticidal ingredients. Place one collar around the dog's or cat's neck, allowing a spacing of 2 fingers between the collar and neck. Leave 5-8 cm on the collar for extra adjustment. [Ample room should be left for growth, if being used on puppies or kittens (if applicable).] Cut off any excess length and dispose of it in household garbage. When collar is first worn, observe the pet's neck area every few days for irritation or adverse reaction. Do not use on dogs or cats under 12 weeks of age. Consult a veterinarian before using on sick, aged, pregnant or nursing animals or animals receiving drug or other pesticide treatment. Do not use this product on dogs or cats at the same time or within 30 days before or after treatment with, or exposure to, cholinesterase-inhibiting drugs, pesticides or chemicals. Replace this collar no more than once every XX weeks or months. Replace collar every XX weeks or months for continual pest control in situations where there is an ongoing risk of pest infestation. Retain packaging information for future reference.

For effective flea and tick control, treatment of the pet should be combined with sanitation of any area used by the pet. Vacuum floors, carpets and furniture (discard vacuum bag after use) and wash the pet's bedding, living quarters and surrounding areas. If pest problems persist, an insecticidal treatment of the premises may be required. A veterinarian should be consulted when flea infestation continues to be a problem on the pet.

Precautions

Humans: Keep out of reach of children. do not allow children to handle this collar. Dust will form on the collar during storage. Dust may irritate eyes, nose and throat. Harmful if collar is sucked or chewed, or if dust is inhaled or absorbed through skin. Avoid contact with mouth, eyes, skin and clothing. Avoid breathing dust from collar. After handling or applying, wash hands (or any other skin that came into contact with the product) with soap and water. Avoid product contact with food, food utensils or places where food is prepared or stored.

Pets: Dust may irritate eyes, nose and throat. Harmful if collar is chewed or swallowed. Avoid contact with the dog's or cat's mouth, face, eyes and genitals. Avoid letting the pet inhale the dust from the collar.

First Aid

Humans: If sucked or chewed, obtain medical attention or call a poison control centre immediately. If unintentional skin contact occurs, wash affected areas with soap and water. If dust from collar gets in eyes, flush eyes with plenty of water. If skin or eye irritation persists, obtain medical attention. If dust from collar is inhaled, seek medical attention.

Pets: Sensitivities may occur after using any pesticide for pets. If signs of sensitivity occur remove collar and bathe your pet with mild soap and rinse with large amounts of water. If signs continue, consult a veterinarian immediately. If swallowed or chewed, consult a veterinarian.

Take container, label, or product name and P.C.P. Registration Number with you when seeking medical or veterinary attention.

Toxicology Information: This product contains a pesticide that is a cholinesterase inhibitor (an anti-cholinesterase compound). Symptoms of human poisoning may include headache, weakness, sweating, blurred vision, nausea and diarrhea. Obtain medical attention or call a poison control centre at once. Atropine is antidotal. Acute symptoms of overdosage in dogs or cats include diarrhea, salivation, vomiting, muscular tremors and weakness. Contact a veterinarian immediately.

Storage: Store in original, unopened container at room temperature.

Disposal: Dispose of any excess collar, packaging and unwanted (used) collars in household garbage.