Re-evaluation Decision RVD2012-07, Fenoxaprop-P-Ethyl

Pest Management Regulatory Agency
4 June 2012
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2012-7E-PDF (PDF version)

Table of Contents

• Re-evaluation Decision
• What Does Health Canada Consider When Making a Re-evaluation Decision?
• What Is Fenoxaprop-P-Ethyl?
• Health Considerations
• Environmental Considerations
• Measures to Minimize Risk
• Other Information

Re-evaluation Decision

After a re evaluation of the herbicide fenoxaprop-P-ethyl, Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the  Pest Control Products Act, is granting continued registration of products containing fenoxaprop-P-ethyl for sale and use in Canada.

An evaluation of available scientific information found that products containing fenoxaprop-P-ethyl do not present unacceptable risks to human health or the environment when used according to the revised label directions. As a condition of the continued registration of fenoxaprop-P-ethyl, new risk-reduction measures must be included on the labels of all products. Additional data are also required as a result of this re-evaluation.

The regulatory approach for the re-evaluation of fenoxaprop-P-ethyl was first presented in Proposed Re-evaluation Deci sion PRVD2011-04, Fenoxaprop-P-Ethyl, a consultation document.^{Footnote 1} This Re-evaluation Decision^{Footnote 2} describes this stage of the PMRA's regulatory process for the re-evaluation of fenoxaprop-P-ethyl as well as summarizes the Agency's decision and the reasons for it. Appendix I of Re-evaluation Decision RVD2012-07, Fenoxaprop-P-Ethyl  summarizes comments received during the consultation process and the PMRA's response to these comments. This decision is consistent with the proposed re-evaluation decision stated in PRVD2011-04. However, some mitigation measures are revised as a result of comments. Appendix III of Re-evaluation Decision RVD2012-07, Fenoxaprop-P-Ethyl outlines the revised label amendments. To comply with this decision, registrants of products containing fenoxaprop-P-ethyl will be informed of the specific requirements affecting their product registration(s).

What Does Health Canada Consider When Making a Re-evaluation Decision?

The PMRA's pesticide re-evaluation program considers potential risks, as well as value, of pesticide products to ensure they meet modern standards established to protect human health and the environment. Regulatory Directive DIR2001-03, PMRA Re-evaluation Program, presents the details of the re-evaluation activities and program structure.

Fenoxaprop-P-ethyl has been re-evaluated under Re-evaluation Program 1. This program relies as much as possible on foreign reviews. For products to be re-evaluated under Program 1, the foreign review must meet the following conditions:

• it covers the main science areas, such as human health and the environment, that are necessary for Canadian regulatory decisions;
• it addresses the active ingredient and the main formulation types registered in Canada; and
• it is relevant to registered Canadian uses.

Based on the outcome of foreign reviews and a review of the chemistry of Canadian products, the PMRA has made a regulatory decision and requires appropriate risk-reduction measures for Canadian uses of fenoxaprop-P-ethyl. In this decision, the PMRA took into account the Canadian use pattern and issues (for example, the federal Toxic Substances Management Policy [TSMP]).

The PMRA conducted a human health risk assessment for fenoxaprop-P-ethyl. A recent environmental risk assessment of fenoxaprop-P-ethyl from the European Union was found to be an adequate basis for the proposed Canadian re-evaluation decision.

Following the publication of the PRVD2011-04, changes to the registered use pattern of fenoxaprop-P-ethyl were requested by a registrant to address the risks of concern identified in the occupational and residential risk assessments. Uses on sunflower, and feed and forage crops are no longer supported. Risk assessments were updated for scenarios where the proposed changes to the registered use pattern could result in a different outcome (Appendix IV of Re-evaluation Decision RVD2012-07, Fenoxaprop-P-Ethyl).

For more details on the information presented in this summary of Re-evaluation Decision RVD2012-07, Fenoxaprop-P-Ethyl, please refer to the Science Evaluation Section in the related Proposed Re-evaluation Decision, PRVD2011-04, Fenoxaprop-P-Ethyl, and the Appendices I and IV of Re-evaluation Decision RVD2012-07, Fenoxaprop-P-Ethyl.

What Is Fenoxaprop-P-Ethyl?

Fenoxaprop-P-ethyl is a herbicide used to control certain annual and perennial grass weeds in cereals, certain pulse crops, vegetables, certain feed and forage crops, ryegrass grown for seeds, and turfgrass. It acts by inhibiting the synthesis of acetyl CoA carboxylase (ACCase), an enzyme required for lipid synthesis.

Following the publication of the PRVD2011-04, a registrant chose to discontinue one end-use product, Excel Super Post-Emergent Herbicide (Registration Number 21914), resulting in removing support for sunflower and feed and forage crops, and reducing maximum permitted application rates for potatoes, lentils and flax. For turf uses, the number of applications is reduced from a maximum of two to one per year.

Health Considerations

Can Approved Uses of Fenoxaprop-P-Ethyl Affect Human Health?

Fenoxaprop-P-ethyl is unlikely to affect your health when used according to the revised label directions.

People could be exposed to fenoxaprop-P-ethyl through consumption of food and water, working as a mixer/loader/applicator or by entering treated sites. The PMRA considers two key factors when assessing health risks: the levels at which 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 populations (for example, children and nursing mothers). Only uses for which exposure is well below levels that cause no effects in animal testing are considered acceptable for continued registration.

Maximum Residue Limits

The Food and Drugs Actprohibits the sale of food containing a pesticide residue that exceeds the established maximum residue limit (MRL). Pesticide MRLs are established for Food and Drugs Act purposes through the evaluation of scientific data under the Pest Control Products Act. Each MRL value defines the maximum concentration in parts per million (ppm) of a pesticide allowed in or on certain foods. Food containing a pesticide residue that does not exceed the established MRL does not pose an unacceptable health risk.

Fenoxaprop-P-ethyl is currently registered in Canada for use on cereals, certain pulse crops, and vegetables and could be used in other countries on crops that are imported into Canada. MRLs have been established at 0.05 ppm for barley, wheat and dry soybean, and 0.02 ppm for milk. Where no specific MRL has been established, a default MRL of 0.1 ppm applies, which means that pesticide residues in a food commodity must not exceed 0.1 ppm. However, changes to this general MRL will be implemented in the future, as indicated in the December 2009 Information Note, Progress on Minimizing Reliance on the 0.1 Parts per Million as a General Maximum Residue Limit for Food Pesticide Residue.

Environmental Considerations

What Happens When Fenoxaprop-P-Ethyl Is Introduced Into the Environment?

Fenoxaprop-P-ethyl is unlikely to affect non-target organisms when used according to the revised label directions.

Birds, mammals, aquatic organisms, insects, other non-target arthropods, non-target terrestrial plants and soil non-target micro-organisms could be exposed to fenoxaprop-P-ethyl in the environment. Environmental risk is assessed by the risk quotient method-the ratio of the estimated environmental concentration to the relevant effects endpoint of concern. The resulting risk quotients are compared to corresponding levels of concern.

The European Food Safety Authority concluded that the reregistration of fenoxaprop-P-ethyl was acceptable provided risk-reduction measures to further protect the environment were implemented. These conclusions apply to the Canadian situation.

The PMRA re-calculated the buffer zones for products containing fenoxaprop-P-ethly as per the PMRA's current practice for environmental risk assessment. As a result, buffer zones are required for all uses to protect aquatic and terrestrial habitats.

Measures to Minimize Risk

Labels of registered pesticide products include specific instructions for use. Directions include risk reduction measures to protect human health and the environment. These directions must be followed by law. As a result of the re-evaluation of fenoxaprop-P-ethyl, the PMRA is requiring further risk-reduction measures for product labels.

Human Health

• Additional personal protective equipment to protect mixers/loaders/applicators;
• A restricted-entry interval to protect workers re-entering treated sites; and
• Prohibiting use in turf on recreational areas (excluding golf courses) and residential lawns.

Environment

• Buffer zones to protect sensitive aquatic and terrestrial habitats.

Appendix III lists all required label amendments.

Other Information

Any person may file a notice of objection^{Footnote 3} regarding this decision on fenoxaprop-P-ethyl within 60 days from the date of publication of this summary of Re-evaluation Decision RVD2012-07, Fenoxaprop-P-Ethyl. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides and Pest Management portion of Health Canada's website (Request a Reconsideration of Decision) or contact the PMRA's Pest Management Information Service.