EPA's evaluation of pet flea and tick spot-on products

Full disclosure: though I don't work for EPA, all of my salary comes from an EPA grant to my university.

Also, all opinions, inaccuracies, quibbles, quarrels, complaints, awesomeness, etc on this blog are mine alone and do not necessarily reflect those of my employer.

(Zelda gets dosed)

EPA published a press release a few hours ago and held a webinar detailing the results of their year-long analysis of spot-on flea and tick products incident reports.

To give credit where it's due, EPA deserves a pat on the back for having a webinar. True, they didn't advertise it very well, and they kept changing the registration procedure right up until the last minute. But hey. They get a few points from me for the effort for increased transparency. The slides should be available online soon if you missed it (I have copies if you can't wait until then).

The webpage is here and the press release is here. I want to focus on the main bullet points:

Among immediate actions that EPA will pursue are:

1) Requiring manufacturers of spot-on pesticide products to improve
labeling, making instructions clearer to prevent product misuse.

2) Requiring more precise label instructions to ensure proper dosage
per pet weight.

3) Requiring clear markings to differentiate between dog and cat
products, and disallowing similar brand names for dog and cat
products. Similar names may have led to misuse.

4) Requiring additional changes for specific products, as needed,
based on product-specific evaluations.

5) When new products are registered, granting only conditional,
time-limited registrations to allow for post-marketing product
surveillance. If there are incidents of concern associated with
the product, EPA will take appropriate regulatory action.

6) Restricting the use of certain inert ingredients that EPA finds
may contribute to the incidents.

7) Launching a consumer information campaign to explain new label
directions and to help users avoid making medication errors.

Throughout the webinar there was a large emphasis on misuse of these products, ways to minimize misuse, etc. Yes, OK, thanks EPA. Misusing a pesticide can cause health effects. If it's a problem, the solution of making labels more clear is obvious and a good idea. But... tell us something we don't know. Tell us how many incidents happened even when a product was used correctly, and what you're going to do about that. That's what we're really interested in.

It's EPA's mantra: read and follow the label directions. It's good advice up to a point (and I've dealt with plenty of idiots who purposefully put a dog product on their cat, even after reading the directions so I understand trying to drive this point home). However I think it's used too often to relieve them of some responsibility of any negative effect from the products they regulate.

Note that bullets 1, 2, 3, and 7 listed in the press release are all about mitigating consumer misuse. Bullet 5 is just common sense but isn't all that big a change. Bullet 6 annoys me. Why weren't you restricting the use of these mysterious inert ingredients before, EPA? But OK, whatever, you're doing it now. That's good.

Bullet 4 is the most interesting to me. It's also the one that hints that maybe manufactures have some responsibility here besides improving their labels. It's also the bullet that's most vague and non-specific. More details may come out later. EPA made their incident analysis for each individual product available, and I bet there's interesting stuff there. I haven't had a chance to look at them in depth, but I plan to. You should, too. It's not often that EPA publishes incident reports like this. (Notice that they don't list product names. You'll have to look on your product label for an EPA registration number.)

Another impression I got is that EPA is bending over backwards not to single out a specific product or upset the manufacturers. This confuses me. For any other pesticide product, there's a pretty standard way of dealing with any problems. They'll get some complaints about a specific product, they'll look at the complaints and see if they have any merit, inform the manufacturer what they need to change, and then publish a federal register notice talking about any actions they've taken. Browse through the federal register if you don't believe me. This happens all the time, and 99% of the time, it's minor stuff like the manufacture needs to supply additional toxicity info, or change the wording of their label. EPA has no problem publicly singling out products in the past, why the hesitation now? If some of the spot-ons are causing more than their fair share of adverse effects even when used according to label directions, focus on them. Make them change their formulation or percent active ingredient or whatever. Again, with other pesticide products, this happens all the time.

Other important things to note:

During the webinar, one of the speakers Dr. Farwell, the EPA's veterinary toxicologist, mentioned in passing that he uses spot-on products on his own pet dogs. That should tell you something. There's a feeling out there that vets only push these products for the money. It's not true, there is legitimate public health benefit from these products.

EPA only analyzed incident reports from product manufacturers. Some people think this is fishy, but I don't. This is normal for pesticides. Registrants of pesticides are required by law to report to EPA any adverse effects from their products that are reported to them (hint: if you have an adverse effect, call your manufacturer and report it!). However, pet incident reports can also come from other sources that the EPA didn't tap into (for analytical reasons - they had a hard enough time standardizing the reports from different manufacturers). The ASPCA and other pet poison control centers take incident reports, and so does NPIC and some state regulatory bodies. More recently than 2008, there's the vet reporting portal and you can report it directly to EPA by going here clicking on question #1. I hope in the future they'll look at these sources as well.

They're not done with this evaluation. I have a feeling that some of these products will be changing more than just their labels in the next few years. I'm not brave enough to name names, but there's more than one product on that list that I wouldn't miss if it were 'voluntarily canceled'.

Have an opinion about this? Think EPA should ban all spot-on products? Think they should pass the regulation of such to FDA? Think government is interfering too much with the profit margins of the poor manufacturers? EPA set up an email address just for questions and comments relating to this issue: pets@epa.gov

Since that email is likely to be inundated, I would also recommend going to the docket and sending in an official comment. Starting today, there's a 60 day public comment period and EPA is required by law to read (and, I believe, publish) each and every comment sent to them through the docket.

Go to regulations.gov and search for docket ID EPA-HQ-OPP-2010-0229.