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August 2009
(Below is an update to a message posted by Rosemary on 6/28/09)
I heard from Farnam July 31st and they said that the EPA does not consider my dog's condition as a result of their products. They are sending me $77.00 to pay for the product I used ONLY.
They said that because my dog was diagnosed with Autoimmune Hemolytic Anemia the EPA ruled out that Bio-Spot gave him this condition.
James, I'm no doctor, but I can tell you this: My dog got sick within hours of Bio-Spot applied. I just don't know how else to say this.
Thank you for your support and if you see any other information please forward to me.
Rose 8/1/09
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I am writing to you to post my experience with this poison from this past weekend. I bought this product from a local retailer and administered it to my dog as directed on the packaging. Within 2 hours of the initial application, my 7 yr old Golden Retriever, Sasha, started to act really strange. She would get up scurry across the room and fall to the ground. When I let her out to use the bathroom, she would scurry over to the door and fall down as if it were too painful to stand and wait for me to walk over and open the door. Once I opened the door, she scurried up and down the lawn and fell down and started rolling on her back. When she was done going to the bathroom she scurried over to the door and fell in front of the steps. Her behavior had me stumped as to what could be causing this. I tried to Google her symptoms to see if anyone else could clue me into what could be going on and I had no luck. At this point, I still didn't put two and two together that this was an effect from the Bio Spot treatment. After lying in bed listening to Sasha act like she wanted to "Jump Out of Her Skin" and fall to the ground every time she wanted to move I got up and decided to read the Bio Spot package more thoroughly. The package states: Some animals will experience sensitivity and if sensitivity occurs to bathe the animal with mild soap and rinse with large amounts of water. I put Sasha in the bath at 4:30 Saturday morning. I scrubbed her down with plenty of soap and water trying to get this product off of her skin. After rinsing her and drying her off we went back to bed and I would see how she was acting in the morning. I woke that morning at 8:00a anxious to see Sasha back to her sweet self and to my disappointment she was still the same. She would get up scurry across the room and fall down. I decided then to google reviews about Bio Spot to see what others were saying and to my horror and shock I was reading all kinds of horrible side effects this product has left behind on our beloved pets. I immediately called her vet and explained what I gave her and her symptoms. The vet office told me I needed to come in right away. The vet looked her over and uttered the most heart wrenching words I ever heard, Sasha has neurological damage. I started crying uncontrollably and the doctor gave me my options. One was to take her to the local emergency vet hospital and have her stay over night with an i.v. (vet confirmed it would be very expensive), I could take her home and watch to see how she was doing or I can leave her there and have blood work done, a urine test and fluid injections under her skin to flush the remaining toxins out. I told my vet I couldn't afford the emergency hospital and that I would keep her there for the blood work and urine test. The vet said to go get some coffee and she would call me in an hour or so with the results. I cried as Sasha stumbled into the back room for her testing. Just over an hour later the vet called me to tell me her results came back ok and that the poison hadn't gone to her kidney's or liver and that her urine was nice and concentrated which was a good sign. The vet was going to start the fluid injections and I was able to come and pick her up. The vet explained that she was still showing signs of neurological damage. When I arrived to pick her up I asked the vet are you 100% sure this was from the use of Bio-Spot and the vet said without a doubt. To make a long story short, I caught this in time before it could kill my beloved Sasha. The vet said she could be back to 100% but not sure and to keep a close eye on her.
Christine 8/3/09
Thank you for your information. I contacted the President/CEO of Farnam Companies, Inc. personally as he is the main person responsible for allowing this poison to be sold. I have emailed him and sent him a certified letter. I am hoping my letter to him hits home as he is "supposed" to be an animal lover. I also contacted an animal lawyer I know personally to help pursue my case to get this product and others like it pulled from our shelves. I contacted my local news agency and my states congressman and assembly man. I promised Mr. Blomquist I will do everything in my power to get the word out about his detrimental product(s). I will keep you posted on my progress.
Christine 8/4/09
Here [below] is the response from Farnam Companies......I have no clue who this is that responded but the response is not acceptable and will be handled by my lawyer.
Christine 8/5/09
Dear Ms. Pitt:
Thank you for sharing your story with us. I received your e-mail today with Sasha's picture.
I know that there is nothing that we can say that will alleviate the pain of watching a beloved pet family member become ill. We appreciate you communicating with us directly, so that we can offer you some additional resources and options for investigation of this very serious matter.
Please be assured that all of the information you provide about Sasha will be reported to the Environmental Protection Agency (EPA). All pet pesticide products being sold in the U.S.A., both over the counter and through veterinary clinics, are regulated by the EPA. In order to be approved for sale, the EPA requires that all products undergo rigorous safety testing.
Our first priority is that your dog receives the best treatment possible. If you have any questions about her health at this time, we recommend that you contact the Animal Product Safety Service - a division of the ASPCA Animal Poison Control Center. You will be able to speak with a veterinary professional who has expertise in pet product safety and adverse reactions. Your contact with the service will also allow us to submit a more complete case report to the EPA. This free service is available 24 hours a day, and can be reached at 1-800-345-4735.
I can understand how upsetting it can be to search on the internet and see negative stories about a product that you have applied to your pet. The EPA's web site is a good resource for consumers to get information regarding adverse reactions and product safety. It contains reliable information, which cannot be said about all the internet sites that discuss this subject. There is some recent information on the EPA's web site regarding their review of topical products, which includes both over the counter and veterinary brands. For more information on the EPA's evaluation please see
We also want to assure you that the active ingredients found in the Bio Spot(r) Spot on(r) Flea and Tick Control for Dogs can also be found in those sold through veterinary clinics. There are two active ingredients in the Bio Spot(r) Spot On(r) Flea and Tick Control for Dogs. One is a flea adulticide called permethrin which is also found in two products sold through veterinarians (Advantix(r) by Bayer and Vectra 3-D(r) by Summit VetPharm). The other active ingredient is (S)-Methoprene, which is a flea insect growth regulator. This ingredient is also found in Frontline(r) Plus, sold through veterinarians.
In your e-mail, you mentioned the cost of your dog's care. We have a process in place for reviewing veterinary records, and we would be happy to review your case for reimbursement consideration. Please send me your day time phone number or give me a call at 1-800-234-2269, so that I can provide you with all the necessary information and help initiate the review as quickly as possible.
Ms. Pitt, once again, thank you for writing to us. I hope that the information I have provided about the Animal Product Safety Service and the EPA will be helpful in your follow through with this matter. I also encourage you to contact me again, directly, regarding reimbursement of your veterinary expenses. You can reach me by calling 1-800-234-2269, Monday through Friday, 8:00 A.M. - 5:00 P.M. Central Time, or by replying to clsinfo@central.com
Sincerely,
Kellie Cook
Bio Spot/ Central Life Sciences
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For the first time, I gave my dog Bio-Spot August 2 and she has been in the hospital ever since. Her toxicity levels are extremely high and her liver has been damaged.
I'm going to tell everyone I come into contact with not to use Bio Spot!
Robin 8/6/09
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Don't use Sergeants SentryHome - Home and Carpet Spray for dogs anywhere
around cats.
This year is the first year we have had a problem with fleas. The daily rain has kept
us form spraying the yard as we usually do. I went to the store to buy something to
help the situation. I found Sergeants Sentry Home and Carpet Spray. I sprayed
most of the rooms and let it dry as directed. I kept the cat in my bedroom while the carpet dried and the next day I went to work. I left the bedroom door ajar and my cat Sasha went into the other rooms of the house. She was a beautiful black and white
cat with a thick luscious coat. Sassy and sweet personality. I had to work late so I checked in on the dogs and they seemed more tired than usual and I noticed Sasha hadn't eaten her food and it didn't look as though she had drank her water either. I picked her up and noticed fleas so I combed out the fleas. I put some water on my
finger and wet her mouth but she wasn't happy. The next morning I noticed she
didn't run to her bowl when I put out fresh food but I was running late and I thought
maybe it was the fleas. She never had them before and I noticed the spray I had
put down wasn't working in the rest of the house. Late that night when I arrived home
I noticed that she was sleeping in another room. I didn't turn the lights on but I could
see her curled up and she mewed at me. I was so tired it never occured to me there
was something serious wrong. The next morning I awoke startled and jumped out of
bed. Something was wrong! I found Sasha curled up under a table and she acted as though she couldn't move. I picked her up and rinsed her off and then called animal poison control listed on the spray bottle. They said to take her immediately to the Vet. The Vet said he sees this every week with this product and others. He said that female cats are particularly susceptible to being poisoned. Sasha rallied a couple of times
over the next three hours and then passed away. On the back of the bottle it says "Hazards to humans and domestic animals." Then talks about getting it in eyes, etc.
I spent $500. trying to save her and I sent paperwork and told the Sergeants people what happened. They sent a polite letter and a check to reimburse the cost of the product ($12.85) saying they couldn't determine conclusively that it was their product
that caused Sasha to die. The Vet even sent a letter. My cat was never sick, there was nothing new in my home except Sentry. The word has to be gotten out not to use this product around cats. I cry every day and miss my precious Sasha terribly. We had
eight glorious years together but it should have been more. I feel like I killed her by
using this product and believing that companies are more repsonsible. On top of everything - the product didn't work getting rid of the fleas. It seemed to make the
fleas worse.
Anonymous 8/6/09
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We lost our shep/lab last summer to Acute Lymphocytic leukemia. I still blame Frontline, and have been finding out more about the effects of this product. my dog had 2 seizures during the time we used frontline, and we never knew why. we thought she must have been stung by a bee or something. I am still so angry, and YES I do blame Frontline.
Kelly 8/7/09
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Last Saturday I used a flea/tick repellant named Bio-Spot Spot-On for cats on my two precious kitties, Steffy and Toby. After about three hours, my big boy, Toby, started shaking his hind legs like his feet were asleep or something, and he hid under anything he could find to hide under or behind...very unlike him. I called the 800 number on the box, and after being put on hold for over five minutes, I just grabbed Toby and bathed him with Johnson Baby Shampoo. The next day he seemed a lot better.
Yesterday I picked up my cat, Steffy, and she was leaking some foul-smelling fluid. Poor little girl tried to wash it off of me, and she was very upset about what was happening to her...so was I. I called her vet and took her in. The vet asked me if her diet had changed, and I told her no, but that last Saturday I put the Spot-On stuff on her and Toby, and she seemed to tolerate it better than Toby did. Not so, said the vet...she's gotten sick from this stuff, and it has killed many cats and dogs, too. She had some kind of bowel/colon problem, and her anal sac had to be relieved. Then she told me to bathe Steffy in Dawn dish liquid, and if I couldn't do that, bring her back and she would do it, because she had to get this stuff off of her.
I could have lost both of my sweet babies, and I need to help stop this stuff, if I possibly can. Can you help me?
Janet 8/7/09
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I just went through an episode with my dog and I am convinced it was the Frontline Plus I used on her several days before. I was looking for a warning or adverse reactions from the Frontline web site, but couldn't find any. Instead I found your page filled with people's stories of Advantix poison, all similar or worse than what just happened to us.
Last summer I used Hartz on my four dogs, and my chihuahua Sophie had a bad reaction starting about 5 hours later and lasting for nearly 24. Her reaction included sweating, shaking, and tremors, and I was certain she was hallucinating. My vet told me Hartz is no good and does that to a lot of animals, so I should use Frontline or Advantix. I switched to the pills instead, but recently decided to go with the Frontline Plus because Costco sold it half-price. My vet said it's a different medicine than Hartz, so it wouldn't hurt her. I put it on all my dogs last Sunday. Friday morning my Sophie was tired and didn't eat. She's spoiled, so I didn't think anything at the time. A few hours later I found her sweating, drooling, her eye's glazed over and her pupils dilated. I rushed her to my vet. I was told it looked like she had a seizure and that it could be epilepsy. It might also be meningitis or a brain disease, but that all signs pointed towards seizures and not poison. He said take her home and watch her close, and call the 24 hour vet if things got worse - she might have to go on epilepsy meds. I asked about Frontline poison, and told him about the Hartz incident, and he told me Frontline wouldn't poison my dog unless she ingested it. I asked him to do bloodwork to make sure nothing else was wrong. The next day, the vet on call called me with the blood results and told me the only thing he saw was a very elevated and abnormal liver enzine reading. He said this indicated that she ingested something toxic.
Now I keep my house clean and well-organized. My pets cannot get into my garbage, my cleaning supplies, or my perscription or over-the-counter medications. We don't do drugs and we don't smoke. The only houseplant they can get to is the ficas, and they never tried eating it before. I don't feed my pets any harmful human foods and don't keep any out for them to get into. My three small dogs only go outside when under my watch, on a leash because of the cayotes, so it's not possible she ate something outside. The only thing toxic she came into contact with was the Frontline five days prior. And she didn't lick it off of her. She got so mad at me when I put it on her, she refused to have anything to do with me until a couple of hours later when I sponged it off of her. She hadn't even scratched the area to spread it. I thought I got most of it, but some probably remained and took longer to absorb into her skin.
Today, the day after our vet visit, she appears normal but tired. She has had no adverse reaction today. I am convinced that the Frontline was the problem and that some animals are just more sensitive to the poison used in the drug. I'm appalled that the companies that make this do not include warnings. I'm more appalled that my vet told me that it wouldn't poison her, that it was safe. I am afraid that there will be lasting negative affects. One person on your site said that her dog continued to suffer, and is dying from it. I don't think I can go after the company for my vet bills because I didn't save my receipt for the Frontline purchase to prove it was what I used, although I still have the remainder in the box. I am going to complain to the EPA and the drug company that makes this via certified letter, but who's going to listen when my vet says it can't be the cause of the poison. I think I might alert the local news stations as well. If you have any other suggestions on what I can do to help alert the public, please let me know.
Michele B. in Oregon 8/8/09
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my daughter took my cat to the groomer and said he had fleas. he is an inside cat only.
they said wait 2 days to put on advantage. my daughter bombed the house for flea's. so my cat had bomb spray, flea dip, and advantage. my poor cat is dead now and a sm amt of blood came out of his nose after he died. no vomiting, but he did urinate. i am so upset, i was not there do you think it was the advantage that killed him. i know persians have very delicate respiratory systems.
Sandy 8/8/09
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We have a 4 year old pom. We decided to try bio spot instead of the capstar flea pill. We noticed our sweet dog acting strange. He began excessive scratching, what seemed to be pain in his hip area. For 2 nights he did not sleep. We bathed him and used vitamin E lotion where we applied the med. The next morning we took him to the vet. The vet said if we had waited any longer we might not be able to save him.. Please be aware of this for the sake of your precious dogs.
Rita 8/10/09
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Spread the word - don't use Biospot to prevent fleas & ticks on your pets - it doesn't work!!! For years I used Frontline or Advantage, but this year I switched to Biospot - thought I could save some $$$, and all of the writeups on the Drs. Foster & Smith website said how wonderful it was. But now here I am, $223.00 in vet bills later and
with one miserable dog. A couple of weeks ago we noticed Sasha had fleas, which I couldn't believe because I was using the Biospot religiously, so I ran right out and got some Frontline Plus, and it worked, but in the meantime she developed a skin infection and lost all of her hair in an area on her back from digging at it so much. We took her
to the Emergency Vet on Sunday and they gave her steroids and she had an allergic reaction to them - slept for hours and now leaks puddles of urine wherever she goes. The vet at Onion River says that will go away once the steroids wear off. She has one
of the cone collars on, but because she's a big dog and has a long snout, she can still reach the spot to bite at it, so we have to constantly watch her until the antibiotics kick
in enough to clear up the infection. Plus, now we have to rip up the living room carpet & get new a sofa- she slept on it today, plus we're sure they are full of fleas. They were both getting pretty old anyway, so this is a good excuse to do it. I feel awful though- my poor dog - just because I wanted to save a little money. I hope someone can learn from my mistake, and spread the word about Biospot. Also, the vet told us that they had a
Chihuahua there that was in really bad shape because the owner had used a flea treatment from the dollar store. They weren't sure if it was going to recover or not.
Robin 8/10/09
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(Below is email that I sent to the EPA on 8/12/09)
----- Original Message -----
From: "James TerBush" <james@biospotvictims.org>
To: <golberg.aron@epa.gov>
Cc: <gesalman.Claire@epamail.epa.gov>; <ingram.earl@epa.gov>; <nesci.kimberly@epa.gov>; <furlow.calvin@epa.gov>
Sent: Wednesday, August 12, 2009 1:13 PM
Subject: Freedom of Information Act Appeal HQ-RIN-01297-09-A (HQ-APP-00124-09)
Dear Mr. Golberg,
Thank you for taking the time to speak with me this morning in regards to my Freedom of Information Act Appeal, HQ-RIN-01297-09-A (HQ-APP-00124-09). As I mentioned, on July 13, 2009, I received a letter from Kevin M. Miller, Assistant General Counsel, stating that my appeal for a transcript of the EPA's May 5 meeting with the registrants of spot-on flea and tick pesticide products had been denied because "no transcript of the meeting exists. EPA therefore cannot supply you with a copy."
The EPA's May 5 meeting was not open to the public. To the best of my knowledge, the EPA did not make a public announcement of the meeting "at least one week before the meeting, of the time, place, and subject matter of the meeting, whether it is to be open or
closed to the public, and the name and phone number of the official designated by the agency to respond to requests for information about the meeting," nor was a public announcement of the meeting published in the Federal Register, both of which are required by the Government in the Sunshine Act, 5 U.S.C. 552b.
Here is the EPA's website in regards to the Government in the Sunshine Act:
Here is an excerpt:
Transcript of Closed Meetings
"(2) The agency shall make promptly available to the public, in a place easily accessible to the public, the transcript, electronic recording, or minutes (as required by paragraph (1)) of the discussion of any item on the agenda, or of any item of the testimony of
any witness received at the meeting, except for such item or items of such discussions or testimony as the agency determines to contain information which may be withheld under subsection (c). Copies of such transcript, or minutes, or a transcription of such
recording disclosing the identity of each speaker, shall be furnished to any person at the actual cost of duplication or transcription. The agency shall maintain a complete verbatim copy of the transcript, a complete copy of the minutes, or a complete
electronic recording of each meeting, or portion of a meeting, closed to the public, for a period of at least two years after such meeting, or until one year after the conclusion of any agency proceeding with respect to which the meeting or portion was held, whichever occurs later."
I ask that you reconsider my request for a transcript, either in written form or electronic recording, of the EPA's May 5 with the registrants of flea and tick pesticide products. If a written or electronic transcript of the meeting does not exist, please let me know why the EPA violated the Sunshine Act in this instance.
Thank you for your consideration.
Sincerely,
James TerBush
Website Administrator
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Hello James and to all at this site. My name is Bryan and I am writing this email from the small town of Mountain, Wisconsin this summer night, the day after I was forced to make the decision to have my treasured friend and constant companion Sadie put down. Sadie was an unbelievably beautiful being that came in the shape of a Springer Spaniel. Sadie followed in the paw prints of my first Springer named Katie and, as time would tell, she was in all ways just as unique and every bit as special as Katie had become to me, even though at her passing at 16+ years Katie had left me with a belief that I would never find another dog quite like her. I didn't have to...Sadie started out as different as night and day to Katie but both ended up in about the same place, a wonderfully giving and loving being we call a dog. In mid 2008 I purchased a Bio Spot topical tick control product, and read the directions and all closely. I had selected it as a result of its much cheaper cost compared to Hartz and Frontline and others despite all having the same basic ingredients. I am a disabled person and cost is always an issure in my purchasing so I selected Bio Spot. Here in northern Wisconsin we have a tick season from about April thru late July or early August. As I made the purchase in mid-2008 and I applied the first ampule in mid-June and the second one 30 days later in mid-July, and with the near end of tick season had the one remaining container left over. In early April 2009 with the finding of the first ticks on Sadie I pulled out the one remaining container and applied as directed on the packaging to Sadie's upper back/shoulder area. One note...I disregarded the instruction to wear plastic gloves to apply. As I then thought... come on be real, if I am applying this to her back and then reach down to pet her, or hug her, I would end up with this stuff on my skin a lot from now on, so why wear the gloves. In addtion, in the instructions it warned not to apply directly to the dogs skin, and again, common sense had me thinking. First of all, there is so much hair on my dog I couldn't find hardly any skin on the nape of her neck, but being realistic, anything of an oil that I apply to her fur is going to end up on her skin, without a doubt. Two days later I am watching the ABC evening news doing a story about the dangers of these products and lists some of the name brands affected by a EPA warning about the ingredients. And there was Bio Spot. I remember having the exact thought ...did I just poison my dog?! Well time passed, from that mid April day to last Saturday, August 8,2009 without anything of note related to that springtime news story and it had slipped from my thoughts or active memory. On that Saturday I let Sadie out to take care of her daily "chore" at the same time a neighbor had knocked at the door. I only mention this as we chatted and I did not pay strict attention to Sadie except to notice her usual methodology of going, and then let her back into the house without anything out of the norm occuring. A few hours later I noticed she was having extreme difficulty standing and walking on her rear legs, and was also walking a bit spread-legged which is quite out of place for her. Within a few more hours she was lying about without hardly moving, changing her position exactly only 5 times all day and evening. As she could not come into my bedroom while I retired as was her norm, I put a sheet down on the couch and slept there next to her and heard her movements (as she plopped down each time) and was awoken to her every move. Her eyes were bright and normal, and I hand fed her almost her usual consumtion of food and held a bowl of water at the right height and she drank normally. I felt I could wait it out as at this time I thought she had only a possible stiff back or rear legs, perhaps she had jumped into the chair in the house or you know, just about anything, but not great alarm..yet. On Sunday she never moved except her head when I again fed her some dog food and gave her water, but again her head could move and her tail wagged just like always. But I was now convinced there was someting wrong and immediately took her into the vet first thing Monday morning. By then it was apparent she could not bear weight on any leg. A back x-ray revealed nothing of notice (good result?) and the vet spoke of the only redress being a very expensive cat scan kind of procedure and that might find something but was only diagnostic and wouldn't treat the problem at a cost of $1,000. That couldn't be an option for me as to being cost prohibitive plus real treatment costs, etc. The vet went on to say that in these cases that there is rarely improvement and if there was it would take weeks and that by then secondary problems would arise and all of that was logical. It was his opinion that I should put her down. He kept her overnight to give Sadie a max dosage steroid shot in her spinal area along with some other kind of medicine that by keeping her for observation they could give maximum dosaging. When I called the first of the following morning they informed me that there was no change, and so I went out to do the 30 mile drive to the vet, tears obstructing my vision most of the way, as I knew I was going in to put her down. When the doctor and an assistand wheeled Sadie into the room on a cart she was lying there with bright eyes panting and her tail wagging, with apparantly no further movement detected all night and not at that time by me as well. But as she just didn't look "sick" I turned to the vet and eye-to-eye I again asked, "Doc are you sure this is the only choice to make, are you sure we need to do this out of a sure necessity or not and his response was a nod of the head and the words "yes" and that it was the best thing to do even knowing it was difficult a thing to do, that there was little hope for any improvement and the likelihood of other secondary problems that would also set in. And with my beloved friend Sadie in my arms and with my words assuring her of the love felt for her,she closed her eyes and, within a fraction of a second...she was running with her old friend Katie where ever it is that all of the special creatures of the world end up, and where, if we are lucky, will be the same place we are put out to run in too. You see, Katie knew of course, that Sadie was on her way there, and would be the first welcoming furry face that would be there to greet her. When I got home from the vet clinic, I was mentally cleaning up the places I had things of hers, dog food dishes, treats and other things, I passed the drawer where all her past perscriptions were, her clippers and other dog things, when it smacked me in the forehead like an 8 Pound sledgehammer....the story in spring in the news and the tick repellant. I immediately went online and punched into a search engine the words "dog tick remedy problems" and started at a site that with a few link clicks away came upon this site. So many of the painful descriptives I found vocallized here were almost word for word what I watched Sadie live out. To this moment the vet has given no other reason for her condition. Not a clue. So I called back and asked if they had heard of any issue with tick preventative products and after getting all protective and asking,"why.. did you buy a tick product here?" I said no that I wasn't addressing at fault issues nor was I contemplating suing anybody, I just needed some answers to questions that all lead back the one overwhelming question "Why did Sadie die?" They said they sold the Frontline product, which is still probably poison too. So now after finding that the same Bio Spot product is still on the shelf where I purchased it and I now had a vet that claimed they were unaware of any problem with topically applied tick remedies, I have done my homework resulting in finding this site. And if this wasn't already such a blow loosing Sadie, finding I might be culpable in real terms of being the cause by applying that product, I now also realize from reading your letters that she might not have needed to be put down, but truth is she probably would have had permanent problems, so no matter, at least she didn't suffer. So, now armed with this knowledge, and as being historically more than a bit of an activist (I could list my causes and some significant results some other time though) I am going to take this problem on starting with my local politicians and the local ABC Network affiliate in the hopes of generating a story, an investigation, and hopefully finally a ban on the ingrediants of concern here. Judging the dates of many of your articles, it would seem that an alarm is already about 6 or 7 years too late, but to be sure, it is time for this to be addressed and these horrific poisons be taken off the shelves of stores and vet clinics and be sure they are exposed as the toxic death trap they are. I hope this letter adds to the story, as I am left with the task of followup to this tragedy and also try despite my personal situation, to find the means by which I can afford to get another Springer Spaniel friend and companion, not to replace an old friend, but to treasure a completely new set of stories and memories of another 4 legged friend. Thank you for listening to my story. And please do not stop in your effort to get the truth out about these products and to help prevent another Sadie story.
Bryan 8/12/09
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I too, like so many others on this board had a horrible experience with an OTC flea product. The one I used was Zodiac spot-on flea treatment for dogs under 30 lbs. A friend had given me this to try a long time ago, and since I had already purchased many months worth of flea product from my vet, it sat in the cupboard. Unfortunately, I had ran out of my usual product and decided to give the Zodiac a try- what a huge MISTAKE! Within hours my dog was panting heavily, shaking his head, drinking large amounts of water, urinating large quantities all over the house (and he is housebroken!), very "hyper" activing- not able to relax at all, and seemed to be in a great amount of pain- pawing at the ground, writhing around etc... I took him to my vet, who thought he was having adrenal problems- as in Cushings Disease. I couldn't understand how my dog was perfectly healthy one day, and then so severely ill the next, but I am not a Vet.. I had told my vet that I had put on flea product- Zodiac- his only comment was that it is not as "effective" as the Advantage I usually use. I explained that someone had given it to me, so I just thought I would try it... My vet had evidently not heard of this problem with dogs either, so he did not think "toxic reaction" when he saw my dog and his symptoms. They kept my dog there for a few hours to watch him and tested him for Cushing's Disease. He did not want to give him any steroids or any other meds that could make him worse if he did indeed have Cushings disease (adrenal gland problem). I was trying to look up symptoms of Cushings disease when I came across this website and others like it.... what people described was EXACTLY what I had seen in my dog! I rushed my dog
into the bath at 2am-as I was up watching him all night- I was able to stop some of the medication from getting into his system by washing him with the Dawn Dishsoap. I then took him immediately to the vet first thing in the morning and showed my vet printouts of this site. He agreed that he thought my dog had received a toxic dose of the permethrin! (his test for Cushing's Disease came back negative by the way!). He had heard of this problem with cats, but not dogs until now! When I called the ASPCA to report the incident I was told that they are getting more and more calls about this problem in dogs too! It seems to especially be a problem in the smaller dogs. The company that makes Zodiac is Wellmark, so I hope people will contact them also and let them know how ANGRY they are that these poisons are still on the market!! I for one, plan to tell all I know, so that if these profit hungry companies don't remove the products, we can hopefully keep people from buying them!!! I am one of the lucky ones, my dog, after 4 days of suffering, seems to be pulling out of it. He still has an open red/oozing wound that has to be treated and watched, and is still showing some neurological problems
with the head shaking- but that symptom is lessening each day, so I pray he has no permanent neurological damage... If I had not seen this site, my dog could be dead like so many others pets! So sad and so AWFUL that these could have all been prevented if these selfish companies would have even been honest on their packaging... how many of us would use something that says may be TOXIC/LETHAL.... all the packaging said was "may cause sensitivity".. what a joke!!!
Cheryl 8/17/09
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Bio spot almost killed our cat. The 2nd dose we gave our 7 month old cat caused it to go into a seizure. We contacted the vet and gave it a bath (just as you stated on your web site). I held the cat all night trying to let it know we were there. The next morning at 4 a.m. it got up, but by that afternoon it was down again with a high fever. We took it to the vet imediately and was given antibiotics to combat the fever. These are the vets words: Bio Spot should be removed from the market along with one other (i will not name the name since I did not experience it with this product), he also stated he has seen numerous animals, some that have died because of this product. He cannot understand how they get away with selling anything like this that will kill your animal.
Kevin 8/18/09
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(Below is email that I received from the EPA in response to my 8/12 email posted above)
----- Original Message -----
From: <Nesci.Kimberly@epamail.epa.gov>
To: "James TerBush" <james@biospotvictims.org>
Cc: <Golberg.Aron@epamail.epa.gov>; <Furlow.Calvin@epamail.epa.gov>; <Gesalman.Claire@epamail.epa.gov>; <Ingram.Earl@epamail.epa.gov>; <Koch.Erin@epamail.epa.gov>
Sent: Thursday, August 20, 2009 5:21 PM
Subject: Re: Fw: Freedom of Information Act Appeal HQ-RIN-01297-09-A (HQ-APP-00124-09)
Dear Mr. TerBush,
Thank you for your August 12, 2009, email regarding your Freedom of
Information Act Appeal HQ-RIN-01297-09-A (HQ-APP-00124-09).
You are correct that EPA's May 5, 2009, meeting with the registrants of
spot-on flea and tick products was not open to the public and was not
publicly announced. The EPA is committed to transparency during its
review of the spot-on flea and tick products; however, EPA is generally
not subject to the requirements of the Government in the Sunshine Act
(GISA). Information on the GISA is provided on EPA's website because
section 10(d) of the Federal Advisory Committee Act (FACA) provides that
GISA procedures apply to closed meetings of Federal Advisory Committees.
The May 5, 2009, meeting was also not subject to FACA for many reasons,
but most notably because we were not asking for advice.
EPA is committed to transparency and, though we are not required to do
so by law, we have posted a great deal of information on our website on
what we know about these pet incidents so far. Although there is no
"transcript" of the May 5, 2009 meeting, the Agency has made available a
detailed summary of the May 5, 2009, meeting; the sign-in sheets; the
Agency's presentation; and a copy of follow-up correspondence with the
registrants. In addition, we intend to release to the public the
Agency's review of the additional information that we requested at the
May 5, 2009, meeting and have since received from the registrants.
After that report is released, we also intend to publicly announce any
mitigation actions affecting the registrations of pet spot-on products
that the Agency decides are needed to address the animal incidents that
we have been seeing.
We are appreciative of the level of public interest in this topic as we
are conducting our review. We share yours and the public's concerns
about the numbers of incidents that we're seeing with these products and
we are fully committed to addressing this issue. The Agency will make
an independent evaluation of the safety of the pet spot-on products and
will implement any regulatory decisions necessary to ensure that the pet
spot-on products perform their intended functions without posing
unreasonable risks to humans, animals, or the environment. Please
continue to check our website for updates. In addition, please let us
know if you have any additional questions regarding your FOIA request
and appeal.
Best regards,
Kimberly Nesci
Kimberly Nesci, Product Manager 11
Insecticide Branch
Registration Division (7505P)
Office of Pesticide Programs
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I have been using bio spot for 3 months now, until recently I've read a lot of bad, horrible stuff about it. I never really thought about it being bad for my dog. Within the last four days a ball size "thing" developed on my dog in her rib area on the left side. The EPA has classified it as a possible human carcinogen because it increases the frequency
of lung and liver tumors in laboratory animals. I just noticed this last night 8/20/09, and
I can't make it to my local vet till Saturday morning, I'm thinking more and more that
bio spot has something to do with what's going on. Diamond is only 2 1/2 years old, she's full of energy, and rambunctious as can be, she even is laying on that side. When touched it doesn't seem to bother her. I'm very concerned and don't know what to do!
Anonymous 8/21/09
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Hi, I found your website when trying to find out details about Triforce. I have used Frontline for a few years and have had no problems. But I tried Sentry Pro once a while back. I went to Petco and thinking I could trust what is on their shelf I looked at all the
flea products. I decided on Sentry Pro because it was not the cheapest stuff and the packaging looked very convincing. I thought, why not save some money and use this kind, it says it is safe and effective. I put it on my dogs one evening and they very quickly started going nuts. They were running around the house, itching, rolling, whining, they acted like something was after them. I pretty quickly called the vet and he gave us a number to an emergency clinic in a bigger city about an hour away. They automatically said Yes this product causes problems. Wash in dishsoap immediately. They said it makes them feel like they are being crawled all over by bugs. So we did that and they continued to be itchy and crazy for a few hours. But they had no more problems, My dog who is only 7 now has kidney disease and I wonder if it could be related to that getting into her system because she has always been very healthy. Anyway, I am very lucky to have not had more problems as I can see by others stories on the website. Now I see that I will for sure not be using Triforce and I'm worried about even using Frontline. I have used it for a while during the bad months but I dont want to cause any damage to my kids. I'm thinking of spraying the yard with something and giving them frequent baths, hopefully putting off getting fleas so that I dont have to use Frontline. Thank you for the website, It is unbelieveable that so many people have problems with Bio Spot and Sentry Pro yet even upscale pet stores like Petco keep it on their shelves. Without knowing from experience, anyone would try the products, they look good and why
would we not trust Petco, Petsmart, ect. with our pets??
Brittany 8/23/09
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(Below is email that I sent on 8/24 to Kimberly Nesci at the EPA in response to her
email posted above)
Dear Ms. Nesci,
Thank you for taking the time to respond to my August 12, 2009, email regarding my Freedom of Information Act Appeal.
I was glad to hear you say (twice) that the EPA is committed to transparency, and I very much appreciate the amount of information that your Agency has posted on its website concerning its investigation of spot-on flea and tick products. My only hope is that your Agency is equally committed to seeking public involvement as it attempts to find a solution to this serious problem.
In the Meeting Summary of the May 5, 2009, meeting with registrants of spot-on flea
and tick products, one of the slides in the presentation states, "EPA is committed to working with registrants and stakeholders to best determine how to address this issue." Stakeholders are defined as individuals or representatives from organizations or interest groups that have a strong interest in your agency's work and policies. Does
your agency consider pet owners and companion animal advocates to be stakeholders in this matter? What about veterinarians who routinely find themselves caring for pets that have been poisoned by these products? Does your agency plan to hold meetings with them?
As you know, the EPA has a Public Involvement Policy, which states, "Effective public involvement can both improve the content of the Agency's decisions and enhance the deliberative process. Public involvement also promotes democracy and civic engagement, and builds trust in government. The Agency should approach all decision making with a bias in favor of significant and meaningful public involvement. Experience throughout government has shown that a lack of adequate participation or of effective means for participation can result in decisions that do not appropriately consider the interests or needs of those that will be most affected by them." This policy applies to
all EPA programs and activities.
The number of companion animals that are harmed each year by EPA-registered flea and tick products is unacceptable. The danger these products pose to small children is even more appalling. Holding closed door meetings with product registrants to "best determine how to address this issue" goes against the spirit of the EPA's Public Involvement Policy, and is contrary to your stated committed to transparency.
Meaningful public involvement, including open meetings, insures that the concerns of
all stakeholders will be considered in the decision-making process.
Thank you for your consideration.
Sincerely,
James TerBush
Website Administrator
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I recently noticed some fleas on my 2 year old pedigree Border Terrier so I washed him with the Bob Martin shampoo.
Two days later he was booked in at the vet for a microchip fitting so I mentioned the fleas and he said the shampoo was not one he would recommend and he recommended Frontline which I applied 2 hours later.
Within 2 hours of applying it we noticed the dog was very lethargic and didn't want to go for a walk which he absolutely loves so we thought it was just the stress of having the microchip inserted. The next day the dog was so poorly i.e. vomiting, lethargy, not eating, we took him back to the vets for examination and they said he probably had an infection and put him on antibiotics and some other medication.
I did ask the vet if this was linked to the microchip as my dog had been like a spring chicken prior to this and the Frontline but didn't ask about the Frontline as I thought there cannot be a problem with it (wish I had seen this website earlier). The next 36 hours he went downhill fast and I took him to the emergency dept, after some blood tests and more antibiotics I got a phone call to say he was critical and to expect the worst, when they got the results of the blood test they said he had acute Leukaemia and there was
no hope or cure for him.
Yesterday I had to see a dog that was fit and healthy five days ago be put to sleep I am heartbroken.
Do you think this is just a coincidence?
Tony 8/25/09
UK
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Why is this product still OTC !!!
My baby, Enzo, is I am sure a victim. Yesterday, I put the Bio Spot on him
and within hours the reactions caught on. He was so uncomfortable and I was
wondering what on earth is going on. He never use to scratch or go crazy and
now he is scratching like crazy on the two spots I put the Bio Spot on. In
addition, he started acted weird, he would not leave my side and I couldn't
sleep at night because he couldn't stand still. In the middle of the night
he couldn't sleep and I couldn't sleep either. He started shaking all night
and I believe he was seizureing. Every other minute he would shake like a
crazy like a convulsion or spasm ( I guess that is a seizure?). Then in the
morning I woke up to see diarrhea. He is still scratching the area and as
soon as I read ur website I immediately put him on the sink and washed all
the crap off with Dawn. I just finished.
I feel so sorry for him. He is only 1 year old and I wanted to prevent him
from getting those darn summer fleas and ticks. I am sure that this is
happening b/c of the Bio Spot, no doubt. He was always happy and healthy
until now. I had to hold him tight when he was shaking. I hope that
comforted him and I am not letting him out of my site. Tell me what I can do
to get this crap out of the market. And I just realized ..how they could
sell something that can harm another animal I.e. cat ?
My poor baby Enzo did not have to go through this! Now he is still
continuing scratching the floors and beds like they usually do b4 they go to
sit on it (he is a poodle). He has been doing this more than usual all over
the apt. He look calmer now. I hope the bath works.
Any comments or suggestions. I do not have that much time to read the whole
website but I applaud you on your kindness.
Caroline 8/26/09
Nultey, NJ
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(Below is email that I sent to the Animal Legal Defense Fund on 8/27/09)
I searched your website for information concerning pets that have been injured by flea and tick products, but the only information that I came across was this:
You may have heard that the EPA issued an Advisory concerning dangerous flea and tick products in April:
The EPA received over 44,000 reports of adverse incidents in 2008 alone - including hundreds of severe adverse reactions and deaths. Unfortunately, only a small percentage of these incidents are ever suspected or reported to anyone. If these incidents are not considered by the ALDF to be abuse and cruelty, then your organization really needs to rethink its definition of those terms.
Please let me know if there is anything your organization can do to prevent companion animals from being harmed by pet pesticide products, or make it easier for companion animal owners to seek reimbursement for damages and veterinary expenses through the legal system.
Thank you for your consideration.
Sincerely,
James TerBush
Website Administrator
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(Below is email that I received from the EPA in response to my 8/24 email posted above)
----- Original Message -----
From: <Nesci.Kimberly@epamail.epa.gov>
To: "James TerBush" <james@biospotvictims.org>
Cc: <Golberg.Aron@epamail.epa.gov>; <Gesalman.Claire@epamail.epa.gov>; <Koch.Erin@epamail.epa.gov>; <JJdachs@aol.com>; <Johnson.Marion@epamail.epa.gov>
Sent: Thursday, August 27, 2009 4:10 PM
Subject: Response to your August 24, 2009, email.
Dear Mr. TerBush,
Thank you for your August 24, 2009, email and for your thoughtful
response to my message.
The Office of Pesticide Programs has a long history of commitment to
transparency and public participation in its regulatory decision-making
processes. We intend to honor that commitment in our evaluation of the
pet spot-on products.
I would like to clarify the intent of our May 5, 2009, meeting with the
registrants. This meeting was held to explain our concerns and request
additional information specific to the registration licenses held by
each company. It was an information-gathering meeting with the
companies who are legally obligated to report incidents to the Agency.
This was not a meeting to discuss how to address the Agency's
concerns or to "best determine how to address this issue."
Our enhanced analysis of the incidents associated with all pet spot-on
products is critical in order for the Agency to best determine how to
address this issue. We agree that the numbers of animals experiencing
incidents each year are unacceptable; for that reason we initiated this
analysis. The analysis is expected to be complete in the fall of 2009,
after which we will release that report to the public on our Web page.
As stated in our slides, we are committed to working with registrants
and stakeholders to best determine how to address this issue. Please be
assured we do consider individuals, pet owners, advocacy groups, and
veterinarians to be "stakeholders" in this matter. After our analysis
has been released, we will involve the public and all stakeholders in
our decision-making process. As mentioned in my original email, the
Agency is committed to implementing any regulatory decisions necessary
to ensure that the pet spot-on products perform their intended functions
without posing unreasonable risks to animals, humans, or the
environment.
Also as mentioned in my previous email, we appreciate the level of
public interest in this topic and we share your and the public's (along
with all stakeholders') concerns. We will continue to be in touch.
Best regards,
Kimberly
Kimberly Nesci, Product Manager 11
Insecticide Branch
Registration Division (7505P)
Office of Pesticide Programs
**********************************************************************************
I just spent an hour on your site reading stories. I found your site in reference to
search about bio-spot. I had not heard of that product and was ready to purchase
a 6 mth supply and decided to research product lst. I thank - you sincerely for your
site as I am sure many many others do. Thank Goodness I found your site and information. I feel very lucky I am not having to write a sad story. It Broke my heart reading everyones stories. No words can comfort.
I wish you great success with your mission.
Kimberly 8/27/09
Indiana, USA
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I came across your site when I did a search for "fleas". I have three cats and I am
thankful to GOD that I have never used biospot on them. I really appreciate your efforts
in trying to warn pet owners about this awful flea treatment. You are an angel, and I'm sure you have saved many a pet because you put your website up! Good work!
God bless you, for protecting animals!!!!!
Colleen 8/27/09
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My cat almost died in May after my husband applied Bio Spot for Cats to her. Emergency vet services pulled her through, and we and our vet reported the incident to EPA. We sent a hair sample to the manufacturers lab, and after 10 weeks, Farnum sent me a letter saying the hair sample showed permethrin (supposedly not in BioSpot for Cats) and did not show methoprene insect-growth regulator (which is in BioSpot for Cats). So basically, Farnum is telling me it couldn't have been their product that caused my cat's life-threatening seizures.
Something's not right here because I know the Bio-Spot for Cats is the culprit. She's a young, healthy cat; BioSpot for Cats was the only product applied to her; our other cats and dogs received Frontline Plus that month (which does not contain permethrin); we are experienced pet owners of dogs and cats for over 30 years and have never had an incident before, and we also have birds so we are extremely cautious with all household chemicals.
I have one more applicator from the pack that harmed my cat and I am trying to determine the best place to have it analyzed chemically by an independent laboratory. I have contacted the EPA and am waiting to hear back from them.
I am curious as to how you were reimbursed by the manufacturer, when my experience thus far is they are telling me it couldn't have been their Bio Spot. But I know it was because there is no other possible source of chemical toxicity in our cat except the Bio Spot for Cats applied to her 24 hours before she began experiencing seizures.
Any suggestions for an independent lab test for the extra applicator I still have? Any suggestions on how to convince Farnum that it was their product that almost killed my cat? In addition to seeing Bio Spot for Cats removed from the commercial marketplace, I'd like to recoup the over $800 in emergency vet expenses it cost us as a result of using Farnum's dangerous product.
Thanks for any ideas.
Pam and Jose 8/28/09
North Port, FL and Suches, GA
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I have asked Farnum for a copy of their lab report on Moonshine's hair sample. No response from them on that in the past 2-3 weeks.
Moonshine had NO other drug exposure except the Bio-Spot for Cats. We didn't use any sort of premises spray in our home, our other pets received Frontline Plus (no permethrin), and she is strictly an indoor cat, so she didn't get into permethrin outside (nor did our other pets--our 3.5 acres are all fenced. No other dogs ever come onto our property).
The emergency vet diagnosis was permethrin toxicity.
The only explanations that makes sense are:
(1) the Bio Spot for Cats erroneously contained permethrin,
(2) the Farnum lab analysis of Moonshine's hair sample is wrong or bogus,
(3) Moonshine reacted to Entofenprox, a pyrethroid pesticide in Bio Spot for Cats which can cause a syndrome like permethrin toxicity.
I'm working on arranging for that independent lab analysis from my home state (FL) environmental/consumer pesticide governmental department.
Hopefully, results from the independent lab analysis will show that the Bio Spot for Cats we applied erroneously contained permethrin. If not, I tend to doubt I will be able to get her hair sample back from Farnum for re-testing.
All I know is that I'm positive we applied the correct cat product correctly and Moonshine almost died 24 hours later. I know it was the Bio Spot. I think Farnum is stonewalling. Trying to reconcile all the chemical and hair sample test results looks daunting to this non-toxicologist, but there's no doubt in my mind the product is dangerous and should be withdrawn from the market.
I'll keep you posted on what happens.
Pam 8/30/09
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(Below is email that I sent on 8/31 to Kimberly Nesci at the EPA in response to her
email posted above)
Dear Ms. Nesci,
Thank you again for responding to my August 24, 2009, email, and for your clarification of the EPA's May 5, 2009, meeting with registrants.
I truly hope that your analysis of the incidents associated with pet spot-on products will determine that chemical burns, seizures, and death are unreasonable risks to pets, and that swift regulatory action is long overdue. However, after reading the EPA's recent
review concerning the relationship between pyrethroid exposure and asthma, I am not very optimistic that your agency has the willingness or ability to protect pets and people from these dangerous products.
The more than 44,000 adverse incidents that were reported to the EPA last year are indicative of a failed regulatory system - one that consistently underestimates the risks that pet spot-on products pose to animals and humans (especially children). Several
factors have contributed to this failure, including: inadequate companion animal safety studies that lack scientific integrity, the use of industry-backed probabilistic risk assessments (despite data gaps in the toxicity database), bowing to industry pressure by lowering the FQPA Safety Factor, failure to take into consideration the maximum application rates of products when calculating the estimated risk to toddlers from incidental ingestion of residues on pets via hand-to-mouth after pet treatments, failure to account for aggregate and cumulative risks of pyrethroids, inadequate warning statements on pesticide labels, inadequate or tainted adverse incident data from registrants, and inadequate post-market surveillance.
The above deficiencies in your agency are not a recent phenomenon, as indicated by this EPA memorandum from 1996:
Excerpts:
"The safety requirements for regulation of pet pesticide products have been ill-defined and inconsistently applied in the past."
"The Occupational and Residential Exposure Branch (OREB) has been asked to provide the Special Review Branch (SRB) with an overview of pesticides registered for direct use on domestic animals. It is our understanding that the issue of pet pesticide products has been on the SRB's unfunded list for several years."
"The regulated industry has acknowledged that EPA's safety requirements for pet insecticides are less rigorous than those of the Food and Drug Administration for veterinary drugs (including topical preparations)."
"Due to resource constraints, the majority of the incidents for domestic animals have not been evaluated and entered into the HED Screens. In addition, the Information Services Branch is having difficulty processing all of the incoming reports."
"Most pet product labels contain the KEEP OUT OF REACH OF CHILDREN statement but do not warn against contact with the treated animal."
In May 2006, unions representing more than 9,000 EPA scientists and risk managers sent a letter to EPA Administrator Stephen Johnson, expressing concerns that pressure from the pesticide industry was leading to EPA decisions which endangered public health:
Excerpts:
"We Local Presidents of EPA Unions representing scientists, risk managers, and related staff, are writing to express our concern that EPA could betray the public trust by violating the intention of the Food Quality Protection Act (FQPA) to protect the Nation's
infants, children, and susceptible subpopulations, unless the Agency adheres to principles of scientific integrity and sound science in the pesticide tolerance reassessments it is undertaking."
"Accordingly, as EPA approaches the August 2006 statutory deadline for the determination of final tolerances for the remaining OP and carbamate pesticides, we urge the Agency to adhere to its principles of scientific integrity and employ the precautionary approach intended by the FQPA in assessing the cumulative and aggregate exposure and risk from the uses of these neurotoxicants. This approach - compliance with the FQPA and our principles of scientific integrity - is the only way to remain faithful to the public trust and ensure that our children will not be exposed to pesticides that may permanently damage their brains and nervous systems."
"The Agency's own Scientific Advisory Panel (SAP) has expressed concern that the Pesticide Program's current approaches may not be sufficiently conservative, may underestimate the risks to infants and children, and do not adequately identify individuals that may be inherently sensitive to neurotoxicants."
"We are concerned that the Agency has not, consistent with its principles of scientific integrity and sound science, adequately summarized or drawn conclusions about the developmental neurotoxicity data received from pesticide registrants....Consequently, EPA's risk assessments cannot state with confidence the degree to which any exposure of a fetus, infant or child to a pesticide will or will not adversely affect their neurological development."
"Many influential proponents of agriculture have repeatedly expressed their concerns to EPA about properly coordinating with agricultural stakeholders, the U.S. Department of Agriculture (USDA), and producers when implementing FQPA. It appears that the Agency has inadvertently taken this to mean that the concerns of agriculture and the pesticide industry come before our responsibility to protect the health of our Nation's citizens. We are concerned that the Agency has lost sight of its regulatory responsibilities in trying to reach consensus with those that it regulates, and the result is that the integrity of the science upon which Agency decisions are based has been compromised."
"Our colleagues in the Pesticide Program feel besieged by political pressure exerted by Agency officials perceived to be closely aligned with the pesticide industry and former EPA officials now representing the pesticide and agricultural community; and by the USDA through their Office of Pest Management Policy. Equally alarming is the belief among managers in the Pesticide and Toxics Programs that regulatory decisions should only be made after reaching full consensus with the regulated pesticide and chemical industry."
"We therefore request the following: 1. Where data are insufficient for decision-making, that you make decisions based on the Precautionary Principle and add appropriate uncertainty factors to protect human health in conformity with the FQPA and our principles of scientific integrity."
"We believe that it would be a perversion of the constitutional process and betrayal of the public trust for the agency to fail to adhere to the mandates of the FQPA."
Nowhere is the betrayal of public trust more evident than in the Reregistration Eligibility Decision for d-Phenothrin, which occurred in September 2008. Below are the events which led up to that decision.
In 2006, McLaughlin Gormley King Company (MGK) requested to use phenothrin over agricultural lands to control mosquitoes. The EPA concluded that MGK's application was a food use which required the establishment of a 0.01 ppm tolerance on all crops, and a reregistration process for phenothrin was required to assess the risk of the new pending use.
On November 27, 2007, HED's Occupational and Residential Exposure Assessment for phenothrin found, "Exposure and risk estimates indicate that three of the residential scenarios result in exposures of concern (i.e., MOEs<1000)." The MOE for risks to toddlers from incidental ingestion of residues from a spray product on pets via hand-to-mouth after pet treatment was 150.
On February 6, 2008, HED issued a revised risk assessment for phenothrin after receiving additional data from the registrant, but still determined that "a number of residential exposure scenarios present risks of concern." The MOE for risks to toddlers from incidental ingestion of residues on pets via hand-to-mouth after pet spray treatment was still 150.
On March 5, 2008, MGK made a slide presentation to the EPA titled, "Sumithrin - Exposure and Risk Analysis of Indoor Residential Uses." One of the slides stated,
"Residential scenario MOEs are acceptable."
"Reasonable certainty of no harm can be substantiated via refined assessments."
"Continued registration is appropriate."
On May 21, 2008, HED issued a revised addendum "to include a pet use scenario that was omitted from the original assessment due to a calculation error. This addendum provides an assessment of residential exposure from use of d-Phenothrin in products EPA Reg. Nos. 2596-150 and 2596-151, which are registered for use as spot on treatment for dogs and puppies. HED's corrected assessment of these products indicates risks of concern to toddlers from incidental ingestion of residues on pets via hand-to-mouth after pet treatment.... The estimated MOE for risks to toddlers from incidental ingestion of residues on pets via hand-to-mouth after pet treatment is 46." The revised addendum used an application rate of 2.6 mL per 31 lb. dog, based on the label.
On July 2, 2008, HED issued another revised risk assessment, "to address public comments submitted on the d-phenothrin risk assessment dated February 6, 2008."
Excerpts:
"The toxicity database for phenothrin is incomplete. The toxicity database lacks acceptable neurotoxicity studies that are required to fully evaluate risks to infants and children."
"Phenothrin is lacking acute, subchronic and developmental neurotoxicity studies."
"Residential post-application exposure and risk to phenothrin was assessed using both deterministic and probabilistic modeling approaches. The results of the deterministic residential post-application exposure assessment indicate risks of concern
(i.e., MOEs<1000) for the following residential scenarios;...incidental ingestion of residues on pets via hand-to-mouth after pet treatment."
"Probabilistic exposure assessment is recognized as a refinement over deterministic assessment because it incorporates the full range of exposures and their associated probabilities. Therefore, HED's conclusions regarding potential risks of concern for residential indoor post-application incidental oral exposures to phenothrin are based on the results of the probabilistic assessment. Based on the probabilistic assessment, MOEs were below 1000 at the 99.9th and 99.5th percentiles for the pet care spot-on and indoor carpet powder scenarios."
"Currently, phenothrin is lacking acceptable neurotoxicity studies and these studies are considered data gaps."
"As noted, developmental effects were observed in the rabbit developmental study."
"Endocrine-related effects were observed in tests which indicated potential estrogen, androgen, and/or thyroid mediated toxicity."
"The toxicity database is incomplete for a full hazard evaluation, but is considered partially adequate to evaluate risks to infants and children. The toxicity database lacks acceptable acute, subchronic, and developmental neurotoxicity studies."
"There are no dermal absorption studies available with phenothrin. A conservative dermal absorption estimate of 2.0% was selected based on available dermal absorption studies in pyrethrins and/or pyrethroids."
"Historically, HED has used deterministic techniques (i.e. point estimates) for its exposure assessments due to the difficulty in generating and characterizing the various inputs in the form of probability distributions. However, HED has recently begun to address these issues and is moving toward developing probabilistic approaches to estimating residential exposures."
"While it is not standard HED policy to use probabilistic methods for residential exposure assessment, recent advances in probabilistic models and the availability of more robust exposure factor data enable HED to utilize such tools."
"Results of the probabilistic CARES assessment for indoor post-application incidental oral exposure scenarios are presented in Table 19....MOEs below 1000 were scenario at the 99.9th and 99.5th percentiles for the pet care spot-on and indoor carpet powder scenarios." Pet Care Spot-on MOE=674 at 99.9th percentile, MOE=860 at 99.5th percentile.
On August 19, 2008, HED issued an addendum to the residential exposure assessment. "This is an addendum to the Health Effects Division's (HED) July 2, 2008 assessment of residential exposure and risk for d-phenothrin (B. Daiss, D326945). This addendum provides a refined assessment of residential exposure from use of d-Phenothrin as a spot on treatment for dogs and puppies. The probabilistic assessment conducted previously for this scenario indicated risks of concern to toddlers from incidental ingestion of residues on pets via hand-to-mouth activity. This refined assessment incorporates an incidental oral toxicity endpoint which was derived using Benchmark Dose analysis. Based on this refined analysis, this pet treatment scenario does not present risks of concern." The BMD estimated MOEs for pet care spot-on in children 1-2 years from hand-to-mouth exposure are 1350 for 99.9th percentile, and 1700 for 99.5th percentile. The application rate used in HED's Benchmark Dose analysis was 0.09 fl oz (2.6mL)/per 6000 cm squared (2230 mg ai/animal).
In September 2008, EPA issued its Reregistration Eligibility Decision for Phenothrin, which concluded, "the data are sufficient to support reregistration of all products containing phenothrin."
Here is an EPA memorandum concerning the revised residential exposure assessment for amitraz:
Excerpt:
"For risk assessments, HED always considers the maximum application rates allowed by labels in its risk assessments in order to be able to consider what is legally possible based on the label."
However, HED did not use the maximum application rate when it calculated the residential exposure assessment from use of d-Phenothrin as a spot on treatment for dogs and puppies. HED incorrectly based its calculation on Hartz Advanced Care and Hartz InControl brands of flea and tick drops for dogs and puppies, EPA Reg. Nos. 2596-150 and 2596-151, which were labeled for dogs 31-45 lbs., and have an application dosage of 2.6 mL. HED could have based its calculation on Hartz UltraGuard brands of flea and tick drops for dogs and puppies, which are also EPA Reg. Nos. 2596-150 and 2596-151, and which are labeled for dogs 31-60 lbs., and have an application dosage of 4.1 mL. Since HED always considers the maximum application rates allowed by labels, it should have based its calculation on Hartz UltraGuard brands that are labeled for dogs over 60 lbs., and have an application dosage of 5.9 mL.
If HED had based its calculation for the pet treatment scenario on the Hartz UltraGuard brands of spot-on treatment for dogs and puppies, its Benchmark Dose analysis would have indicated that this pet treatment scenario presents risks of concern for toddlers.
Please heed the request of your own scientists and risk managers, "Where data are insufficient for decision-making, that you make decisions based on the Precautionary Principle and add appropriate uncertainty factors to protect human health in conformity with the FQPA and our principles of scientific integrity." Probabilistic risk assessments and Benchmark Dose analysis should not be used by your agency to circumvent the Food Quality Protection Act.
I urge the EPA to revise its residential exposure assessment for phenothrin using Hartz UltraGuard brand of spot-on treatment for dogs and puppies, using both the 4.1 mL and the 5.9 mL application dosages, and cancel the registration of these products, effective
immediately.
In addition, the EPA should perform a residential exposure assessment for all brands of pet spot-on treatments, based on the maximum application rates allowed by labels, and cancel the registration of any product that presents risks of concern for toddlers.
Thank you for your consideration.
Sincerely,
James TerBush
Website Administrator
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DISCLAIMER: Below are messages that I have received from others whose dogs and cats experienced adverse reactions after using flea control products. I have no way of knowing if the information in these messages is factual, or if the products they used were the actual cause of the adverse reactions.
