ARCHIVED - Proposed Re-evaluation Decision PRVD2011-04, Fenoxaprop-P-ethyl

22 February 2011
ISSN: 1925-0959 (print version)
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2011-04E (print version)
Catalogue number: H113-27/2011-04E-PDF (PDF version)

Summary

Table of Contents

• What Is the Proposed 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
• What Additional Scientific Information Is Required?
• Next Steps

What Is the Proposed 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 and  Regulations, is proposing 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 label directions. As a condition of the continued registration of fenoxaprop-P-ethyl uses, new risk-reduction measures must be included on the labels of all products. Additional data are also being requested as a result of this re-evaluation.

This proposal affects all end-use products containing fenoxaprop-P-ethyl registered in Canada. Once the final re-evaluation decision is made, the registrants will be instructed on how to address any new requirements.

Proposed Re-evaluation Decision PRVD2011-04, Fenoxaprop-P-ethyl, is a consultation document that summarizes the science evaluation for fenoxaprop-P-ethyl and presents the reasons for the proposed re-evaluation decision. It also proposes additional risk-reduction measures to further protect human health and the environment.

The information is presented in two parts. The Overview describes the regulatory process and key points of the evaluation, while the Science Evaluation provides detailed technical information on the assessment of fenoxaprop-P-ethyl.

The PMRA will accept written comments on this proposal up to 45 days from the date of publication of the Proposed Re-evaluation Decision PRVD2011-04, Fenoxaprop-P-ethyl. Please forward all comments to Publications

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 andthe environment. Regulatory Directive  DIR2001-03, Pest Management Regulatory Agency Re-evaluation Program, presents the details of the re-evaluation activities and program structure.

Fenoxaprop-P-ethyl, one of the active ingredients in the current re-evaluation cycle, 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 re-evaluation decisions;
• it addresses the active ingredient and the main formulation types registered in Canada; and
• it is relevant to registered Canadian uses.

Given the outcome of foreign reviews and a review of the chemistry of Canadian products, the PMRA will propose a re-evaluation decision and appropriate risk-reduction measures for Canadian uses of an active ingredient. In this decision, the PMRA takes 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 (EU) was found to be an adequate basis for the proposed Canadian re-evaluation decision. 

For more details on the information presented in this overview, please refer to the Science Evaluation section of Proposed Re-evaluation Decision PRVD2011-04, Fenoxaprop-P-ethyl. 

What Is Fenoxaprop-P-ethyl?

Fenoxaprop-P-ethyl is a herbicide that is used to control certain annual and perennial grass weeds in cereals, certain pulse crops, vegetables, certain feed and forage crops, as well as ryegrass grown for seeds, and turfgrass. Fenoxaprop-P-ethyl is applied using aerial or ground application equipment. 

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 by consuming 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 population (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 Act prohibits 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/on certain foods. Food containing a pesticide residue at 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, vegetables, certain feed and forage crops and could be used in other countries on crops that are imported into Canada. No specific MRLs have been established for fenoxaprop-P-ethyl in Canada. 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 using the toxicity exposure ratio method - the ratio of the predicted environmental concentration to the relevant effects endpoint of concern. In this assessment, the resulting toxicity exposure ratios are compared to corresponding levels of concern. A toxicity exposure ratio greater than the level of concern is considered a negligible risk to non-target organisms, whereas a toxicity exposure ratio less than the level of concern indicates some potential risks of concern.

Measures to Minimize Risk

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. As a result of the re-evaluation of fenoxaprop-P-ethyl, the PMRA is proposing further risk-reduction measures for product labels.

Human Health

• Additional protective equipment to protect mixer/loaders
• A restricted-entry interval to protect workers re-entering treated sites
• A restriction on the amount handled per day
• Application on recreational areas and residential lawns are prohibited
• Application by high pressure handwand is prohibited

Environment

• Additional advisory statements
• Buffer zones for terrestrial habitat 

A submission to implement label revisions will be required within 90 days of finalization of the re-evaluation decision. Appendix V of the Proposed Re-evaluation Decision PRVD2011-04, Fenoxaprop-P-ethyl lists all proposed label amendments.

What Additional Scientific Information Is Required?

Data are required as a condition of continued registration under Section 12 of the Pest Control Products Act. The registrants of fenoxaprop-P-ethyl must provide these data or an acceptable scientific rationale to the PMRA within the timeline specified in the decision letter that will be sent to the registrants of the technical active ingredients by the PMRA. Appendix I of the Proposed Re-evaluation Decision PRVD2011-04, Fenoxaprop-P-ethyl lists all data requirements.

Next Steps

Before making a final re-evaluation decision on fenoxaprop-P-ethyl, the PMRA will consider all comments received from the public in response to this consultation document. The PMRA will then publish a Re-evaluation Decision document that will include the decision, the reasons for it, a summary of comments received on the proposed decision and the PMRA’s response to these comments.