EPA waarschuwt voor gevaren met antivlooien producten voor honden en katten

Door het resultaat van een verhoogd aantal rapporten van de bijwerkingen van het gebruik van actuele vloproducten, treft EPA maatregelen. Om te proberen om de veiligheid van chemische antivlo producten te verhogen.

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EPA Evaluation of Pet Spot-On Products: Analysis and Mitigation Plan
The U.S. Environmental Protection Agency is pursuing a series of actions to increase the safety of spot-on pesticide products for flea and tick control for cats and dogs. Immediately, EPA will begin reviewing labels and determining which ones need stronger and clearer labeling statements. EPA will also develop more stringent testing and evaluation requirements for both existing and new products. EPA expects these steps will help prevent adverse reactions from pet spot-on products.

EPA is coordinating with Health Canada and with the Food and Drug Administration’s Center for Veterinary Medicine on these actions. Canada identified similar concerns with incidents being reported from the use of spot-on products. The two countries have very similar products registered and some of the same registrants, and we often work together on review of data submissions. Some flea and tick products are drugs that are regulated by the FDA. We are collaborating with FDA as well because FDA regulates some similar products and it made sense for EPA to learn about FDA's processes and learn from its experience in post-market surveillance of incidents associated with animal drugs.

We will continue to reach out to the public on actions EPA is taking and provide information that will help consumers use pet pesticide products safely. By using pesticide products correctly, including determining whether or not they are needed, consumers can help protect their pets.

Results of this Evaluation of Pet Incidents
EPA is committed to sharing information with the public, so we are making available the report that our expert team of veterinarians wrote based on their findings. This report needs to be read with an understanding of the data limitations that the team faced, as described in the report.

Recommendations to reduce harmful effects include:

Further Restrictions on Products

Dosing. To address concerns about dosing, the Agency is pursuing requiring label and/or packaging changes that would result in more narrow pet weight ranges per vial size. This means there will be more categories for the weights of pets so that small, medium, and large dogs get the right amount of product. Pet owners should always be aware of the weight of their pet and purchase and use the correct product for their pet’s weight.

Improve labeling to avoid confusion between dog and cat products. Because there were problems reported with cats exposed to dog products, the Agency needs to address this problem and is pursuing the following actions:
Label changes that prohibit the use of the same brand names on cat and dog products; and
Requiring appropriate, clear label statements to address concerns with cat exposure to dog products as a result of direct application or interactions between cats and dogs in multi-pet households after the application of dog products.

Make labels more understandable. To improve label clarity, EPA will pursue changes such as larger fonts and pictograms.

Make other label changes as needed. EPA will meet with companies individually to review their products and discuss additional changes to labels or ingredients that the Agency feels are needed. These actions may include anything from adding a more complete list of potential side effects to product labels to canceling products.

Inert Ingredients. To address uncertainties about the “inert” (non-active) ingredients in these products and how they might contribute to toxicity, EPA will be pursuing the following actions:
No longer allow the interchangeable use of inert ingredients in these formulations;
Determine whether additional information is needed and, if so, require that information to evaluate certain inert ingredients; and
Disallow inerts that have suspected toxic effects when and if these are identified.

Conditions of Registration. Based on what we currently know about these pet products, EPA expects to impose conditions of registration when granting amendments to existing products or granting new registrations. As with any registration action, EPA will review each application on a case-by-case basis to determine whether these conditions are appropriate and applicable to the product in question. The expected conditions are as follows:
A two-year registration time limitation from the date the product is released for shipment
Only one, basic confidential statement of formula
The submission of quarterly incident reports and an analysis of these report
The submission of quarterly sales information by doses sold
Tighter Regulation
Standardized reporting. To be able to monitor these products better, EPA is pursuing more standardized reporting on adverse effects and sales. This will allow the Agency to more effectively review incidents, and if concerns are raised, give EPA information to act.
Pre-market clinical trials and post-market surveillance. The Agency is taking steps to bring data requirements in line with FDA’s requirements for similar products. This will allow EPA to be more consistent with how FDA regulates similar animal drugs, which includes pre-market clinical trials and a formal post-market surveillance program, and will allow the Agency to more thoroughly assess the safety of the products.
Grant conditional registrations for new products. Future pet spot-on registrations and amendments to new registrations will be restricted by appropriate conditions and time-limitations to allow EPA to continue to ensure the safety of these products after they are available to the public.
For more information, see EPA’s mitigation plan and slides.

Meer informatie: www.epa.gov/pesticides/health/petproductseval.html

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