Pest Management Regulatory Agency
7 December 2012
ISSN: 1925-0940 (PDF version)
Catalogue number: H113-25/2012-28E-PDF (PDF version)
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Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the
Pest Control Products Act and
Regulations, is granting full registration for the sale and use of Mint-X Super Perfume Blend and Mint-X Treated Plastic, containing a mixture of the technical grade active ingredients methyl salicylate, cornmint oil, camphor oil and eucalyptus oil, to be used in the manufacture of trash bags with a claim of reducing the number of trash bags torn by Norway rats and racoons.
An evaluation of available scientific information found that, under the approved conditions of use, the product has value and does not present an unacceptable risk to human health or the environment.
These products were first proposed for registration in the consultation documentFootnote 1 Proposed Registration Decision PRD2012-13, Mint-X Super Perfume Blend. This Registration DecisionFootnote 2 describes this stage of the PMRA's regulatory process for Mint-X Super Perfume Blend and summarizes the Agency's decision and the reasons for it. The PMRA received no comments on PRD2012-13. This decision is consistent with the proposed registration decision stated in PRD2012-13.
For more details on the information presented in this Registration Decision, please refer to the Proposed Registration Decision PRD2012-13, Mint-X Super Perfume Blend that contains a detailed evaluation of the information submitted in support of this registration.
The key objective of the Pest Control Products Act is to prevent unacceptable risks to people and the environment from the use of pest control products. Health or environmental risk is considered acceptableFootnote 3 if there is reasonable certainty that no harm to human health, future generations or the environment will result from use or exposure to the product under its conditions of registration. The Act also requires that products have valueFootnote 4 when used according to label directions. Conditions of registration may include special precautionary measures on the product label to further reduce risk.
To reach its decisions, the PMRA applies modern, rigorous risk-assessment methods and policies. These methods consider the unique characteristics of sensitive subpopulations in humans (for example, children) as well as organisms in the environment (for example, those most sensitive to environmental contaminants). These methods and policies also consider the nature of the effects observed and the uncertainties when predicting the impact of pesticides. For more information on how the PMRA regulates pesticides, the assessment process and risk-reduction programs, please visit the Pesticides and Pest Management portion of Health Canada's website at healthcanada.gc.ca/pmra.
Mint-X Super Perfume Blend, a mixture of the technical grade active ingredients methyl salicylate, cornmint oil, camphor oil and eucalyptus oil, is used in Mint-X Treated Plastic to be used in the manufacture of trash bags with a claim of reducing the number of trash bags torn by Norway rats and racoons.
Mint-X Super Perfume Blend is unlikely to affect human health when used according to label directions.
Potential exposure to Mint-X Super Perfume Blend may occur when domestic users handle the treated trash bags formulated with Mint-X Super Perfume Blend. When assessing health risks, two key factors are considered: the levels where no health effects occur and the levels to which people may be exposed. The dose levels used to assess risks are established to protect the most sensitive human population (for example, children and nursing mothers). Only uses for which the exposure is well below levels that cause no effects in animal testing are considered acceptable for registration.
The technical grade active ingredient, Mint-X Super Perfume Blend,is a concentrated mixture containing essential oils and it is likely to be acutely toxic via the oral route and severely irritating. The Mint-X Super Perfume Blend label has signal words, precautionary and hygiene statements to protect occupational workers during the formulating process.
The treated plastic bags, manufactured using Mint-X Treated Plastic, are made by incorporating a low concentration of the technical grade active ingredient mixture (less than 1%) on to the polymer matrix, and it is not likely to be released from the matrix or significantly absorbed via skin contact. Due to the physical nature and the proposed use pattern of the treated bag, there is no health concern from the intended use.
Dietary risks from food and water are not of concern.
The treated plastic bags, manufactured using Mint-X Treated Plastic, have no food uses; therefore, there are no dietary risks from its intended use. No exposure to residues in drinking water is expected because of the nature of the product.
Risks are not of concern from the intended use of trash bags manufactured with Mint-X Treated Plastic
The proposed manufacturing product is treated plastic, for use in the manufacture of trash bags for use in homes, formulated with a low concentration of Mint-X Super Perfume Blend (less than 1% w/w). Residential exposure is not expected to result in unacceptable risk.
An environmental assessment was not required for this application.
Mint-X Treated Plastic, for use in the manufacture of trash bags, reduces the number of trash bags torn by Norway rats and raccoons.
Labels of registered pesticide products include specific instructions for use. Directions include risk-reduction measures to protect human and environmental health. These directions must be followed by law.
The key risk-reduction measures being proposed on the label of Mint-X Super Perfume Blend to address the potential risks identified in this assessment are as follows.
Since Mint-X Super Perfume Blend is a concentrated mixture containing essential oils and the available information indicate one or more of the active ingredients are acutely toxic via the oral route of exposure and irritating, and there are no studies submitted to characterize Mint-X Super Perfume Blend, signal words are required on the manufacturing product label. The principal display panel of the technical product label must include the signal words: WARNING - POISON, WARNING - EYE IRRITANT, and WARNING - SKIN IRRITANT.
The additional precautionary statements required on the secondary display panel of Mint-X Super Perfume Blend include: "Harmful or Fatal if swallowed, May cause respiratory irritation, Avoid breathing vapors, Handle the product in a well-ventilated area, Causes eye and skin irritation, and DO NOT get in eyes, on skin or on clothing."
The relevant test data on which the decision is based (as referenced in PRD2012-13, Mint-X Super Perfume Blend) are available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa). For more information, please contact the PMRA's Pest Management Information Service by phone (1-800-267-6315) or by e-mail (pmra.infoserv@hc-sc.gc.ca).
Any person may file a notice of objectionFootnote 5 regarding this registration decision within 60 days from the date of publication of this Registration Decision. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticide and Pest Management portion of the Health Canada's website (Request a Reconsideration of Decision, www.hc-sc.gc.ca/cps-spc/pest/part/protect-proteger/publi-regist/index-eng.php#rrd) or contact the PMRA's Pest Management Information Service.
"Consultation statement" as required by subsection 28(2) of the Pest Control Products Act.
"Decision statement" as required by subsection 28(5) of the Pest Control Products Act.
"Acceptable risks" as defined by subsection 2(2) of Pest Control Products Act.
"Value" as defined by subsection 2(1) of Pest Control Products Act "...the product's actual or potential contribution to pest management, taking into account its conditions or proposed conditions of registration, and includes the product's (a) efficacy; (b) effect on host organisms in connection with which it is intended to be used; and (c) health, safety and environmental benefits and social and economic impact".
As per subsection 35(1) of the Pest Control Products Act.