PMRA Guidance Document, First Aid Labelling Statements

Organization: Health Canada or Public Health Agency of Canada

Date published: 4 March 2022

Document history (revision/update)

Disclaimer

This document does not constitute part of the Pest Control Products Act or its regulations and in the event of any inconsistency or conflict between the Act or regulations and this document, the Act or the regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the regulations and the applicable administrative policies.

Table of contents

• Executive summary
• 1.0 Purpose
• 2.0 Scope
• 3.0 Policy
• 4.0 Background
• 5.0 Summary
• 6.0 Consultation
• 7.0 References
• Appendix I - Guidance for content of first aid instructions
• Appendix II - Related documents

Executive summary

This document discusses the first aid labelling policy of the Pest Management Regulatory Agency (PMRA) for products registered under the Pest Control Products Act. It provides guidance for how labeling must address poisoning incidents, and evidence supporting such guidance.

1.0 Purpose

The purpose of this document is to communicate to industry, and other interested parties, revisions to label statements addressing first aid measures in the event of accidental ingestion of pesticides. The intent is to reflect modern medical practices in relation to handling poisoning incidents and further harmonize pesticide labelling practices with the United States. These changes involve the FIRST AID section of the label.

2.0 Scope

This policy applies to the FIRST AID section of any label for all products subject to registration under the Pest Control Products Act.

3.0 Policy

The PMRA proposes to implement these label changes using the most efficient means. It is proposed that these label statements would become effective within 60 days of this regulatory directive for any new applications or applications for amendment. For new applications or applications for amendment that are with the PMRA for which the Agency has not yet issued an annotated label, the PMRA will incorporate the appropriate changes into the label. For products that are already registered and do not have a current open application, amendments should be made at renewal.

4.0 Background

The Pest Control Products Regulations require that pesticide product labels include first aid instructions, specifically "the practical measures to be taken in the event of poisoning, intoxication or injury caused by the control product". The PMRA procedural practice indicates these measures are those that can be safely implemented prior to obtaining medical assistance. Information directed toward medical professionals appears on a product label under a separate section entitled TOXICOLOGICAL INFORMATION. If medical attention is recommended under the FIRST AID section, the following statement is required to be added to the section: "Take container, label or product name and Pest Control Product Registration Number with you when seeking medical attention".

First aid statements provide vital information to pesticide users, physicians, and emergency response personnel; therefore, the PMRA expects pesticide labels to reflect modern medical procedures and treatment. The American Academy of Pediatrics (AAP) issued a policy statement (November 2003) regarding the use of syrup of ipecac, an emetic agent, in the treatment of a poisoning incident in a child. Their policy was revised based on research that failed to show benefit for children who were treated with ipecac following an ingestion event. Consequently, the AAP recommends that syrup of ipecac should no longer be used routinely as a poison treatment intervention at home. Labels for some pesticide products still recommend the use of syrup of ipecac under the FIRST AID instructions when the product has been ingested.

Furthermore, the PMRA is aware that the induction of vomiting as a first aid measure has fallen into disfavour by the medical community due to the complications that can arise from the aspiration of vomitus. Labels for many pesticide products still recommend the induction of vomiting under the FIRST AID instructions when the product has been ingested (an exception where induction of vomiting has been contraindicated is for products containing more than or equal to 10% petroleum distillates).

In re-examining the appropriateness of existing first aid statements, the PMRA also examined current practices of pesticide labelling within the United States Environmental Protection Agency (USEPA). The USEPA issued a Pesticide Registration (PR) Notice (PR Notice 2001-1) in January 2001 providing guidance on the content of first aid statements. The PMRA reviewed the PR Notice to determine potential areas of harmonization in label language, which are also reflected in this directive.

5.0 Summary

On the basis of advice provided by the medical community, the PMRA recommends the following.

• Any reference to syrup of ipecac as a first aid remedial measure must be deleted from all pesticide labels.
• Any reference to induction of vomiting as a first aid remedial measure must be deleted from all pesticide labels.
• When first aid statements are triggered for the oral route of ingestion by the hazard information, the following text should be used for products without petroleum distillates:

IF SWALLOWED: Call a poison control centre or doctor immediately for treatment advice. Have person sip a glass of water if able to swallow. Do not induce vomiting unless told to do so by a poison control centre or doctor. Do not give anything by mouth to an unconscious person.

• When first aid statements are triggered for the oral route of ingestion by the hazard information, the following text should be used for products with >10% petroleum distillates:

IF SWALLOWED: Call a poison control centre or doctor immediately for treatment advice. Do not induce vomiting unless told to do so by a poison control centre or doctor. Do not give any liquid to the person. Do not give anything by mouth to an unconscious person.

While this directive provides guidance on generic first aid statements applicable to most products, these statements may not always be medically appropriate for a particular pesticide product. There may be products for which unique acute toxic effects are identified that necessitate additions or changes to the generic first aid statements. It is the responsibility of the registrant to identify these products to the PMRA along with the rationale for modifying the proposed generic first aid statements.

6.0 Consultation

The PMRA consulted with the medical community on first aid statements in late 2003 and early 2004.

Specifically, the Canadian Pediatric Society (CPS) and the Canadian Medical Association (CMA) were asked for their views regarding the deletions of:

1. syrup of ipecac, and
2. the induction of vomiting as a first aid remedial measure.

The CPS and CMA were also asked if they were aware of any potential exceptions to the proposed deletions. Lastly, the CPS and CMA were consulted on proposed wording regarding first aid for the ingestion of a pesticide.

The CPS endorsed the recommendation to delete syrup of ipecac as a first aid treatment for the ingestion of a pesticide, indicating the home use of ipecac had never been one of their policy recommendations.

The CMA noted the AAP's observations that there is insufficient evidence of the efficacy of ipecac and that ipecac has been improperly administered at home and abused by people with eating disorders. The CMA also endorsed the recommendation to delete syrup of ipecac as a first aid remedial measure. Neither the CPS nor the CMA noted any exceptions to their recommendations.

The CPS as well as the CMA endorsed the deletion of induction of vomiting as a first aid remedial measure with no exceptions.

The following first aid statement is used on pesticide labels in the United States for those products that warrant such statements (in other words, triggered by the toxicology).

IF SWALLOWED Call a poison control centre or doctor immediately for treatment advice. Have person sip a glass of water if able to swallow. Do not induce vomiting unless told to do so by a poison control centre or doctor. Do not give anything by mouth to an unconscious person.

The CPS as well as the CMA agreed with the proposed wording of the above statement. Further, the CPS suggested the addition of a statement regarding dermal exposure. Although not the subject of this regulatory directive, statements regarding first aid measures for all routes of exposure are required when triggered by the hazard information for a particular product (Appendix I).

The USEPA determined that having a person sip or drink water or milk after ingesting a product containing petroleum distillates is unwarranted. Although the Canadian medical community was not consulted on this point, it should be noted that the USEPA made this determination after discussion with their medical experts. Thus, the standard first aid statement for products containing >10% petroleum distillateis as follows:

IF SWALLOWED Call a poison control centre or doctor immediately for treatment advice. Do not induce vomiting unless told to do so by a poison control centre or doctor. Do not give any liquid to the person. Do not give anything by mouth to an unconscious person.

7.0 References

United States Environmental Protection Agency, PRN 2001-1: First Aid Statements on Pesticide Product Labels.

G. R. Bond. Home Syrup of Ipecac Use Does Not Reduce Emergency Department Use or Improve Outcome. Pediatrics Nov 2003, 112 (5) 1061-1064; DOI: 10.1542/peds.112.5.1061

Appendix I Guidance for content of first aid instructions^{Footnote 1}

Appendix II Related documents

This guidance should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents.

This guidance does not identify or establish requirements that are outside or in addition to current legislation. See the Pest control products (pesticides) acts and regulations section of the Canada.ca website for a list of all regulatory requirements.

Please note that this guidance document is in effect as of March 2022