On one hand, their investigation did not result in anything new that pet owners and vets and pesticide agencies have been telling them for over a decade, except that they are now claiming to be more aware of the problems and just a little bit serious in working to increase reporting incidents, renew product study criteria, continue to investigate inert ingredients, and require manufacturers to follow through with their guidlelines.
If you love data, like me, you'll appreciate the links following the article, particularly the 2008 incident data reporting, the individual manufacturers and their suspect products, EPA's investigation results. It is clear the same old manufacturers (OTC crap, you know who they are), fudged their data, omitted critical information, dodged the EPA's criteria, and just kept pumping out harmful products and continue to blame pet owners' stupidity for all those incidents. The EPA too, faulted on inconsistent data, and had to "clean up" their data before their investigation. Un-freaking believable.
They'll continue to do just what they've been doing, except that the EPA claims they will be doing more and requiring more. We'll see.
More information from DVM Newsmagazine.May 2010 edition-DVM Newsmagazine
EPA calls for labeling changes for flea products
Washington- The EPA is calling for labeling changes and increased consumer education to fight off a spike in adverse events associated with spot-on flea and tick control products.
While the agency plans to meet with product manufacturers in May, EPA officials are calling for a series of changes to better educate consumers about the proper use and health risks associated with the use of spot-on flea and tick products.
In a March 17 press briefing, EPA's Steve Owens, an assistant administrator of the Office of Prevention, Pesticides and Toxic Substances, says, "(Current) label warnings simply are not working. They're inadequate. These are products that are designed to kill fleas and ticks, and they do their job. So we are urging pet owners and others who use these products to exercise caution and be very careful when they use these products on their pet."
To combat misuse of spot-on products and decrease adverse events, some of the label changes EPA might pursue include new warnings, a listing of possible symptoms, better labeling instructions, dosage guidelines for consumers, possible restrictions of certain ingredients and possible restrictions on marketing channels. No products are being banned, but Owens says EPA isn't ruling out such drastic measures in the future.
According to an EPA veterinary advisory panel, adverse events were associated with the misuse of dog products on cats, improper dosing and application, which EPA partially blames on instructions that are "buried" in the current product literature.
Adverse events associated with the misuse of dog products on cats have the potential of being so severe, the agency is not ruling out forcing manufacturers to rebrand products entirely.
Thus far, manufacturers of spot-on products have been receptive to EPA's proposed labeling changes, Owens says. EPA's Dale Kemery adds the agency is unsure whether it will require brand-name changes to alleviate customer confusion, but it is a regulatory option under consideration.
Bayer, for one, is holding off on making any changes until it meets with the agency, says Bob Walker, the company's director of communications and public policy.
"The next step for EPA is to meet with each registrant," Walker says. "We've decided that until we have that discussion, we won't jump to any conclusions."
Bayer didn't see an increase in adverse event reports during the time of EPA's product review, Walker says. Neither did Merial, according to its Communications Director Natasha Joseph.
"Although EPA has said that its initiative was prompted by a 'sharp increase' it had noted in 2007 to 2008 in the number of reported adverse events related to the use of spot-on flea and tick control products in general, Merial's data does not indicate this is the case for Frontline." Joseph says. "The number of adverse events reported for Frontline has remained consistently low since the product's introduction in 1996."
The spot-on makers contacted by DVM Newsmagazine say they will cooperate with the EPA.
"I can't stress enough that we're doing everything we can to educate the consumer, but the veterinarian is the first line of good communication," Walker says.
EPA's study of spot-on products was initiated to help the agency better understand why an increasing number of adverse events were reported. The review was initiated in April 2009 after adverse reaction reports jumped from 28,000 in 2007 to 44,000, including 600 deaths, in 2008, according to EPA.
While about 270 million doses were sold that year, the uptick in reports may have been caused by increasing popularity of these products leading to greater chances of adverse events or mishandling, EPA says.
While a majority of adverse event reports were considered minor, other reports were much more serious, including seizures and even death. Reported symptoms included irritation and scratching, vomiting and diarrhea, tremors, depression, seizures, tearing and eye redness, and coughs. The agency is further reviewing the potential risk of all product ingredients, whether active or inert.
The most common reactions were the result of cats exposed to dog products, using products on pets weighing less than the weight range allowed and using spot-on products on pets younger than the age permitted on the label. Most of the reactions occurred in dogs younger than 3 years of age and smaller breeds, EPA reports.
EPA Data Evaluation Records of 2008 Pet Spot-On Products:
http://www.epa.gov/pesticides/health/pe ... sders.html
March 2010 Review of Enhanced Reporting of 2008 Pet Spot-On Incidents:
http://www.regulations.gov/search/Regs/ ... ntType=pdf
April 2010 OPP Updated Actions on Pet Spot-On Flea and Tick Products:
http://www.epa.gov/oppfead1/cb/ppdc/201 ... spoton.pdf
EPA Evaluation of Pet Spot-On Products: Analysis and Mitigation Plan:
http://www.epa.gov/pesticides/health/pe ... seval.html