Friday, June 12, 2009

EPA scrutinizing Flea and Tick Products

According to June’s issue of the Veterinary Practice News (VPN), the US Environmental Protection Agency (EPA) is currently intensifying its evaluation of whether further restrictions on the use of spot-on flea and tick control pesticides are in order. With the measurement the agency aims to better protect our pets. Under review are both, veterinary as well as over the counter products.

The magazine reports that according to an EPA spokesman this all comes because of the recent increase in reported incidents: In 2008 44,000 plus potential incident cases with registered products were reported. By federal law, all EPA registrants are required to submit reports of possible adverse reactions if they are possibly related to the use of the registrant’s products. These reports are to be submitted regardless of whether the product was or was not used according to manufacturer’s instructions.

Flea and tick products are available in a variety of application media, such as spot-on’s, sprays, collars and shampoos, however, according to VPN, most EPA reported incidents are based on spot-on products, which is what the evaluation seems to be focused on.

Active ingredients in those products include amitraz, cyphenothris, dimotefuron, etofenprox, fipronilimidicloprid, metaflumizon, permethrin, pyriproxyfen and S-methoprene. The EPA according to the magazine claims, that the adverse reactions reported ranged from skin irritations to seizures and unfortunately in some cases were even fatal.
VPN further reports that the evaluation started out at mid April of this year with a few products from about 7 different manufacturers, but by now was by the EPA extended to include all EPA registered spot-on flea and tick products. The EPA on its website provides a
complete list of all registered products.

I visited the agency’s website and apparently “Since the chart previously located on this page reflected only a portion of the numerous pet spot-on products available, EPA felt that pet owners and consumers might be led to believe that only those products listed were the focus of concern. In fact, EPA is intensifying its evaluation of all spot-on products and is providing a more comprehensive list of these products.”

At this point I feel that it is also important to reiterate that “EPA is not initiating a product recall of these products nor is the Agency suggesting that the products not be used. EPA recognizes the importance of the products in effective flea and tick control. EPA’s objective at this stage is simply to advise consumers and pet owners to exercise caution when using the products and to monitor pet behavior following their use, as some animals have experienced adverse reactions following treatment.”

Here is the agency’s view on all of this:
“Pets may experience adverse reactions from flea and tick control products, including spot-on treatments, sprays, collars and shampoos. However, the majority of reports to EPA are related to flea and tick treatments with EPA-registered spot-on products. Spot-on products are generally sold in tubes or vials and are applied to one or more localized areas on the body of the pet, such as in between the shoulders or in a stripe along the back.
Flea and tick products can be appropriate treatments for protecting your pets and your family’s health because fleas and ticks can transmit disease. While many people use the products with no harm to their pets, EPA recommends that pet owners take precautions when using these products. People should carefully follow label directions and monitor their pets for any signs of an adverse reaction after application, particularly when using these products for the first time. Also, before use of these products on weak, aged, medicated, sick, pregnant or nursing pets, or on pets that have previously shown signs of sensitivity to pesticide products, EPA recommends that a veterinarian be consulted.”

Additional safety tips are available for
taking care of fleas and ticks on your pet.

As VPN writes, it is all a “Matter of Perspective: One needs to temper the 44,000 potential incidents with the available units for sale in the field, said Mark Newberg, director of corporate affairs at Central Life Sciences of Schaumburg, Ill. In that context, he said, the number of adverse reactions turns out to be very small.
“And of those 44,000, I’m going to guess that the lion’s share are mild or moderate reactions,” he said.
Newberg said he believes that many of the reports involve consumers applying the product incorrectly. For example, he said, because of the ailing economy, some consumers buy a product for a larger animal and mete it out over several months instead of buying the proper dose.
“It may sound like something that everybody is preaching, but (it comes down to) the label directions,” Newberg said. “Nowhere on the label directions do you see, ‘Split up doses.’ It says very clearly, ‘Do not use these products on cats’ when they are designed for dogs. I don’t know how much clearer you can be.”
What more can be done?
“That’s exactly what the EPA meeting is for,” Newberg said. “Once we put the cards on the table, we will have the opportunity to look at the adverse reactions. Maybe there will be a sub-meeting or subgroup that puts together a task force to look at labeling. … They may come back after the meeting and say these instructions are very clear and maybe change the way adverse incidents are reported, so that numbers don’t skew one way or another.”
Whatever the result, Newberg said he is anxious to work with the EPA on this issue.”

Here are some reactions coming from the manufacturers mentioned in the VPN article: “Common misuses include pet owners applying a spot-on product dose that is inappropriate for the pet’s size and applying a product designed for a dog on a cat and vice versa, said Hal Little, DVM, director of field veterinary services for Merial Ltd. of Duluth, Ga. That is why following instructions and working with a veterinarian are so important, he added.
“The veterinarian is a very important gatekeeper,” Dr. Little said. “Clients should be working with their veterinarian, asking questions, talking about directions and about the products.”
Merial maintains that while the EPA noted a “sharp increase” in the number of reported adverse events associated with spot-ons, company records do not indicate such a case for Frontline.
“The number of adverse events reported per volume of sales has remained consistently low since the introduction of Frontline in 1996,” Little said. “Over 1 billion doses of Frontline have been sold, so there is extensive experience with the product in marketed use.”
Merial and other spot-on product manufacturers are working with the EPA. A meeting was to be held in May in conjunction with the Canadian health department, which has identified similar concerns.
Fort Dodge Animal Health of Overland Park, Kan., is working closely with the EPA to identify and resolve any issues related to ProMeris for dogs, spokes-man Ryan Noonan said.
“Before ProMeris for dogs was released to the market in 2007, it went through extensive clinical testing,” Noonan said. “Because ProMeris is a new product, there may be more questions related to its use, as compared to other available spot-on products that have been on the market for a number of years.”
Mark Levin, vice president of technical affairs at Sergeant’s of Omaha, Neb., said he thinks the increased number of reports can be tied to the fact that products traditionally sold through the veterinary channel are being sold over the counter.
“The one item we feel we at least need to get on the table … is that when (veterinary products) are sold to a consumer and the consumer has an issue with that product, they take it and the animal back to the vet,” Levin said. “The vets don’t necessarily report those adverse events back to the manufacturer. Whereas for our over-the-counter products, if a consumer has a problem with our product, they call us directly and we respond with those numbers to the EPA.”
In regard to reports of incidents involving Sergeant’s products, Levin said those numbers are low.
“We don’t feel good about even one case, and we constantly look at any opportunity that we can to improve our products across the board,” he said.
For example, Levin said the company has found cases in which consumers used the wrong size product or used the product on the wrong species. Levin said the company also found cases in which household pets licked each other shortly after application.
Melinda Fernyhough, DVM, Ph.D., manager of Scientific Affairs for Hartz of Secaucus, N.J., agrees that reading the label carefully is important.
“Hartz wholeheartedly en-dorses the EPA advisory’s call to action to pet owners regarding the importance of carefully following label directions and making informed decisions when selecting and using spot-on flea and tick pesticides,” Dr. Fernyhough said. “As the EPA states: ‘The pesticide label is your guide to using pesticides safely and effectively.’”
Fernyhough said that EPA-reported adverse effects for Hartz UltraGuard products for cats decreased in 2008 from 2007 and those for Hartz UltraGuard for dogs maintained the same low ratio of reported incidents to sales.”

While I was browsing around at the EPA’s website I followed the link “
Taking care of fleas and ticks on your pet “ , where among other advice the agency makes a point of how to properly use flea and tick control products:

“To help minimize incidents that may be caused by product misuse, EPA is reminding consumers to always carefully read and follow all instructions on the label for these products and these
Safety tips for pet owners:
Consult your veterinarian:
Before use on weak, aged, medicated, sick, pregnant, or nursing pets, or on pets that have previously shown signs of sensitivity to pesticide products; and
If your pet experiences an adverse effect.
If you use a spot-on product or any other pesticide on your pet, carefully read and follow the product label.
Use flea and tick control products only on the animal specified by the product label, for example, dog products for dogs only and cat products for cats only.
Follow any label prohibitions against use on weak, aged, medicated, sick, pregnant, or nursing pets, or on pets that have previously shown sensitivity to pesticide products.
Apply only the amount indicated for the size of the animal being treated.
Do not apply to kittens or puppies unless the product label specifically allows this treatment. Pay attention to the age restrictions for puppies and kittens on the label.
Monitor your pet for side effects or signs of sensitivity after applying the product, particularly when using the product on your pet for the first time. Do not apply spot-on’s to pets known to be sensitive to pesticide products.
If your pet experiences an adverse reaction, immediately bathe the pet with mild soap and rinse with large amounts of water.
Keep the package with the product container (such as individual applicator tubes). Also keep the package after treatment in case adverse effects occur. You will want to have the instructions at hand, as well as contact information for the manufacturer.
Besides spot-on’s, there are other pesticides registered for flea and tick control on pets. These include shampoos, collars, dust, and sprays. Consumers should apply the same precautions when using these products as recommended for spot-on’s. Pet owners may also wish to consult their veterinarian for advice and recommendations.”

Advice for Reporting Incidents
Keep the package with the product container (such as individual applicator tubes). Also keep the package after treatment in case adverse effects occur. The package contains the product label, which includes important information such as the EPA registration number and contact information for the manufacturer.
Report any adverse effects to the manufacturer, who is required by law to report it to EPA. Contact information can be found on the product label. In addition, you may report the incident to the
National Pesticide Information Center (NPIC), 1-800-858-7378
Encourage your veterinarian to use NPIC’s Veterinary Pesticide Adverse Effects Reporting portal at to report any incidents. This portal is not for use by the public.”

Updated information on the agency’s progress is frequently being made available at

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