Message Board
April 2010
CLASS ACTION LAWSUIT
(03/02/10) Carella, Byrne, Cecchi, Olstein, Brody & Agnello, P.C., has filed a complaint seeking class action status on behalf of pet owners whose household pets were allegedly injured or killed by certain flea and tick products. The complaint was filed in United States District Court for the District of New Jersey against three pet product companies.
The lawsuit seeks injunctive relief in the form of a recall of the offending products, a refund of the purchase price, for compensatory damages, punitive damages and other relief.
For additional information concerning this lawsuit, click here.
If your pet was harmed by a flea and tick product, and you would like to participate in this class action to help get these products off of the market, please contact:
Jacqueline Mottek
Positive Legal Group
415.302.5371 (cell)
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ANOTHER CLASS ACTION LAWSUIT
A class action law firm Green & Pagano LLP is currently investigating complaints from
New Jersey and New York residents whose pets were harmed by spot-on products.
If your pet was harmed by a spot-on product within the past couple years and you live
in New Jersey or New York, please go to: www.SpotOnComplaints.com
or call Michael Green at (732) 390-0480.
For additional information concerning this lawsuit, click here.
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PUBLIC NOTICE
On March 17, 2010, the EPA announced the results of its year-long investigation of spot-on products and proposed a plan to make these products safer for pets.
For more information on the EPA's evaluation of spot-on products, go to:
For more information on the EPA’s plan to make spot-on products safer for pets, go to:
The EPA's plan will do virtually NOTHING to protect pets this year, but hopefully the label changes and proposed stricter regulations (including requiring pre-market clinical trails,
post-market surveillance, and more comprehensive companion animal safety studies)
will begin to reduce injuries and deaths in pets next year.
However, there is a possibility that EPA's plan for stricter regulations will NEVER happen because the pet pesticide manufacturers are opposed to stricter regulation of their industry!
The EPA wants to know what PET OWNERS think about its plan to make spot-on products safer for pets. To submit comments to the EPA, go to:
The fate of EPA’s plan to make spot-on products safer for pets may largely depend on comments from the public, which includes the pet pesticide manufacturers and pet owners like YOU!
Comments must be submitted by 5/17/10.
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About 4 years ago, my elderly dog, Abby, a German Shepard mix did what had been
doing every Spring for the past few years. She could not stand up, was vomiting
uncontrollably and couldn't hold her head up to even keep her airway open. She was
having continuous seizures-twitching and jerking and did not recognize me. She died
at the emergency vet hospital. I didn't realize the cause until just now after reading the
other messages here. I had just put Frontline Plus on her the evening before. I killed
her with this poison that had been recommended by my vet who today has recommended Vectra 3 - which contains one of the same ingredients as Biospot - I DON'T THINK SO!!!!.
I now have 2 other rescued dogs who have problems with bug bites and its only April 1st.
I have searched the web for alternatives to these poisons. I found sites that recommend putting garlic (I don't know if that is safe since I have been told that onions are toxic to
dogs) and Brewer's yeast in the dogs food. They recommended frequent bathing with
a gentle shampoo plus flea combing. It said to dust your house with Diatomaceous earth which has sharp edges that cut the flea larvae and kill them. What does it do when your
dogs ingest it and what about the effects on children? Also spray your yard, as directed,
with Nematodes, a parasite that eats larvae of fleas, mosquitoes and other pesky bugs. Question is - are these actions SAFE and effective? Does anybody know? My neighborhood has more dogs than people and a heavy infestation of mosquitoes, fleas and ticks. Both
I and a neighbor have had Lyme disease. What are we supposed to do to protect our
babies (dogs) and ourselves?
Martha 4/1/10
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James,
Start from the bottom of this exchange [with Drs. Foster and Smith], self explanatory.
Thanks,
Bonnie 4/2/10
(Below is email that Drs. Foster and Smith sent to Bonnie on 4/2/10)
Thank you for your reply.
I understand your concerns.
I have forwarded this email message to Farnum.
Professionally,
Scott A. McKay D.V.M.
Veterinary Services
Drs. Foster and Smith, Inc
2253 Air Park Road
PO Box 100
Rhinelander, WI 54501
715 369-3305 ext: 298
vetservicekr@drsfostersmith.com
More information on pet health and pet care is available on our web
site, www.peteducation.com
(Below is email that Bonnie sent to Drs. Foster and Smith on 4/2/10)
BioSpot nearly killed my 5 pound 3 year old Pomeranian. Within 10
minutes of administering BioSpot in the method given on the package
instructions, my Pom was foaming around her mouth and running wildly
and rolling on her back. she was convussively scratching at her back
and hindquarters and crying.
My veterinarian, Dr. Cheryl Ankenbrandt, DVM of Summerlin Animal
Hospital, 15880 Summerlin Road, Fort Myers, Florida 33908 is filing
the report to the proper authorities. This is the 3rd day since the
near tragedy. My Pom is still in agony with severely aggravated skin,
nervous scratching and wheezing breath and congestion. I have been
in touch with Poison Control and the FDA and reported this near
tragedy. My vet bills and veterinarian prescribed drugs so far are
$111.71.
This drug is an outrage and I'd like to know just how long you plan to
dispense this deadly drug to consumers for their dogs???????????
When I first phoned your 800 customer service number I got some
airhead named 'Nancy' who blithely told me that she "just didn't
understand", after all she "has a friend who dispenses BioSpot to her
dog with no problems!." I asked to speak to any one of the 3 vets you
have on your website and she told me that this is " a most unusual
request but that she would "try to reach one of them by e mail, but,
it may take some time". This call to your 800 customer service number
was made from my veterinarian's office while my pom was still in
emergency treatment. What kind of customer service do you call this?
An owner in dire distress with a dying animal in emergency treatment
and the best your people are trained to do is have 'cute personal
experience' answers?
Yesterday, I got a message, which I missed as I was back at the vet,
from one of your 'vets' who assured me she would follow up with a
phone call today. Well, it's nearly 2:30 here and there has been no
call, nor do I expect one.
I understand that the FDA has initiated an investigation of the drug
used in BioSpot and K9Advantix (Permethrin) about 11 months ago,
I am certain this is not the FIRST report you have of the adverse
affects this is having on innocent animals or the distress it is causing
their owners, your customers. What I cannot understand is why, what
I thought was a reputable and trusted company, Drs. Foster and Smith,
has not pulled these deadly poisonous products off of YOUR shelves
and given the disclaimer of WHY you have removed these products.
Are you so hot to sell product, deadly or not, that you ignore the horrible
results this product is clearly producing to thousands of dog owners
who trustingly order from your catalog and online?
44,000 reports of distress resulting from consumers dispensing
this product to their dogs in the last year, 1,200 dog deaths after
this poison was administered. What does it take Drs. Foster
and Smith???????????????????????????
You forward this to Farum, they are injuring and killing dogs for
profit. And your company, sir, is the 'middle-man' dispensing
this poison.
Bonnie
(Below is email that Drs. Foster and Smith sent to Bonnie on 4/2/10)
Dear Bonnie,
My name is Scott McKay. I am a veterinarian with Drs. Foster and
Smith. I understand your pet had a reaction to the Bio-Spot topical
product you purchased from us. I am concerned about this reaction
and would very much like to visit with you concerning this situation.
I will offer you the customer service number to Farum, the manufacturer
of this product: 18002342269. I’m sure they would like to hear about
this situation.
Please feel free to reply or call with any comments and/or questions.
I am in my office between 8-5, central time, Monday-Friday, at
7153693305 ext 298.
Thank you.
Professionally,
Scott A. McKay D.V.M.
Veterinary Services
Drs. Foster and Smith, Inc
2253 Air Park Road
PO Box 100
Rhinelander, WI 54501
715 369-3305 ext: 298
vetservicekr@drsfostersmith.com
More information on pet health and pet care is available on our web
site, www.peteducation.com
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Our vet started selling Vectra as the only flea and tick medication for dogs (maybe cats,
too, I'm not sure). We tried it twice on our Lagotto. It irritated her skin to the point that she
was sensitive to touch for about 5 days following application. The second time was worse than the first. I called the vet who told me to call the company. The company was totally unhelpful, making me feel like I was the only one who had ever called about such a problem.
A friend who also has a Lagotto used it on her dog only once with very bad results. She
had to sedate her dog for several days until the side-effects wore off.
Jean 4/3/10
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I just adopted a puppy from a rescue group. Gracy had demodex mange. The vet
prescribed Promeris to help get rid of it. I put it on her on Friday afternoon. She and my
mini-schnauzer, Max were playing. They were wrestling around a little bit. After reading some other articles posted I think I now know why Max was having seizures. More than
likely he put his mouth on her back and ingested some of the chemical. Max is on phenobarbytol for seizures and has been for over a year. They have been kept under
control with that medication. The day after they were playing, Max had a pretty bad seizure that morning. He had another that evening, to the point of his back legs started wobbling
and was shaking immediately. I washed the Promeris off of Gracy. I also made sure they didn't rough house for a little while. Even after all of that Max had a 3rd seizure the next evening. These three were definitely worse than the few breakthrough seizures he has had. After I washed Gracy again, Max has had no seizures. They are just having a blast running around crazy. Also, NEVER use HARTZ or SARGENT flea and tick products. I put the Hartz flea tick product on Max and he went into a full blown seizure that lasted about 5 minutes. It makes no since that these companies are still able to put their product on the shelves.
So, I'm looking for an alternative remedy for Gracy's mange and on the hunt for a flea and tick product that won't make Max have seizures. My vet, I thought knew that Max had siezures and therefore wouldn't prescribe something for Gracy that Max could possibly come in contact with, that causes seizures.
Not Happy with Yucky Chemicals!
Kelley 4/5/10
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First, thank you for this website! it was such a help for our situation.
I purchased Adams spot on treatment last summer on vacation when my <1 year old Yorkie got fleas. I didn't use the entire vial because she wasn't yet a year old and I was skeptical, plus she was only about 5 pounds and the packaging said it was for dogs up to 15 pounds. We returned home the following day and gave her a bath and all was well.
We recently moved and my now 1.5 year old 8.5 lb dog was bitten by a tick. I was worried because our area has a high incidence of Lyme disease, so I found the box we purchased last year and used the second treatment. She immediately seemed like it was itching her, but we didn't think it could be really bothering her too much. She had 3 accidents in the house that day which we scolded her for :(
The next day was Easter Sunday. She didn't eat or drink all day and seemed lethargic and just not herself. She tried having food at one point and vomited. We thought it may have been all the excitement of the family gathering, and decided to give her until the next morning to try to eat.
This morning she was acting really weird! She was walking sideways! Still didn't want to eat or play. I googled "walking sideways" and found your site. I read some instructions about bathing her with Dawn so we did, twice. She immediately started walking much straighter, although not completely normal. She is still sleeping a lot but she did eat, finally. I called Farnum to complain and spoke to a Poison Control Center. The Dr explained that she was not being poisoned but that the chemical caused her skin and muscle to have a numb pins and needles feeling. I feel so bad that I blindly used a product that hurt my dog without researching it first. Also, when I used the product, I examined the box for any info on possible complications, and was surprised to see only instructions for use. It was only today, on closer inspection of the box that I realized that the box had a hidden panel that opened to reveal that information. I think that this product is dangerous, but besides that I think the emergency numbers and warnings should not be hidden, but more obviously printed directly on the back of the box. I also think that the warnings of "sensitivities" should be more specific, such as, "call your vet if you notice your dog vomiting, twitching or walking SIDEWAYS"! We really didn't connect that strange symptom to the tick treatment, but thankfully we read about the other sideways walking doggies that had that reaction from similar products. Luckily we washed it off in time...she seems a lot better and we will continue to monitor her.
Thanks again for your informative website and I will make sure to do my part to voice my concerns to the EPA.
Jaime 4/5/10
Farnam pays the ASPCA Animal Poison Control Center to manage their adverse incident claims. That is a conflict of interest! Several people have told me that when they spoke
with a vet at the ASPCA Animal Poison Control Center, the vet advised them that Bio Spot (Adams) does not cause serious adverse reactions in dogs. The vet at the ASPCA Animal Poison Control Center who advised you that your dog was not being poisoned was either badly misinformed or worse. Lethargy, loss of appetite, vomiting, and incoordination are
all signs of pesticide poisoning!
Thank you in advance for letting the EPA know what happened to your dog. You are absolutely right about the warnings (or lack of warnings) on these products.
James TerBush
Website Administrator
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(Below is email that I sent to Kimberly Nesci at the EPA on 4/7/10)
Dear Kimberly,
I read the EPA's evaluation reports concerning incident data for Registrations #2517-80 and #2517-85 (Sergeants cyphenothrin-based pet spot-on products), and would like to bring to your attention a significant deficiency in those reports: the labeled dosages that are currently registered for #2517-80 and #2517-85 are approximately 2X larger than the 1X dosages that were assessed in the companion animal safety study (MRID 46166108).
The report for #2517-80 states: "minor clinical signs were noted in a companion animal safety study, but the effects were not predictive of toxicity reported in the incident reports." The report further states: "It is noteworthy that no systemic neurological signs (such as tremors or ataxia) were observed, and the salivation may have been due to ingestion of small amounts of test material from licking or biting the application area," and: "It is concluded that there is an adequate margin of safety (at least 5X) between the exposure associated with the proposed use level for this formulation in dogs and that at which significant adverse systemic effects (not seen in this study, but which might include ear twitching, muscle tremors, drooling) may occur."
However, the report for #2517-80 made no mention of the efficacy study (MRID 46166109), which noted that the dosages used in the study were approximately 2X larger than the 1X dosages that were used in the companion animal safety study, and that neurological symptoms (including head shaking, vomiting, slight body tremors, ear twitching, unsteadiness, circling, and pacing) were observed in ALL SIX DOGS that took part in the efficacy study.
The report for #2517-85 mentioned the efficacy study (MRID 46166109), and the fact that all six dogs showed symptoms which included vomiting, head shaking, and/or slight body tremors, but made no mention of the larger dosages that were used in the study, and included a possible explanation for these symptoms, which was provided by the registrant, "The reported effects included effects that can be considered normal dog behavior, accentuated under laboratory confinement conditions."
Another area of concern (mentioned in these reports) is that 1.5 mL ampules were the only size used in the companion animal safety study, which delivered approximately 1.17 mL of test material, but mentioned that "the registrant is proposing packaging this product in 3.0 and 4.5 mL (as well as 1.0 and 1.5 mL) tubes." EPA was uncertain of the actual dosage that the larger size ampules would deliver, and had requested additional information from the registrant. It is unclear if the registrant ever provided that additional information.
Here is an EPA review of the efficacy study (MRID 46166109):
Excerpts:
"In the efficacy study (MRID 46166109) dogs were then treated with from 1.45X to 2.65X the indicated label dosage rate (the mean dose of 2.3 mL was 1.97X the indicated label dosage rate.)
"There are obviously some significant inconsistencies between the findings of the companion animal safety study in MRID 46166108 and the efficacy study in MRID 46166109. The occurence of neurological signs of toxicity in all 6 dogs in the efficacy study suggests that there is not even a 2X margin of safety associated with the proposed application rate of 1.17 mL in at least some dogs weighing from 6.8-15 kg, while the efficacy study data, as submitted, were conducted using a dose rate higher than that of the previously reviewed proposed label."
When these inconsistencies were brought to the attention of the registrant, Sergeants informed EPA that the dosages used in the efficacy study were in fact 1X dosage rates. In other words, without EPA's knowledge, Sergeants had increased their proposed label dosages AFTER the companion animal safety study had already been completed.
Here is an EPA follow-up review of the efficacy study:
Excerpts:
"The most likely explanation for the symptoms (including tremors) observed in the efficacy study was that the dogs ingested some of the test material after application."
"Current directions for application of this product specify to apply as a stripe from the back of the neck to base of the tail. If labeling is revised to specify application from the back of the neck to a point midway between the neck and tail then the dog would not be able to reach any part of the application site and so would be unable to ingest the product by licking. With this labeling revision, TRB would have no objections to the registration of the proposed product."
The above memorandum was written by Byron T. Backus, Ph.D., Technical Review Branch, Registration Division.
Incredibly, there was no mention of the fact that the dosages used in the efficacy study were approximately 2X larger than the 1X dosages that were used in the companion animal safety study, nor did the EPA require a new companion animal safety study to determine if a 5X margin of safety existed with the larger proposed dosages and the revised application instructions. THIS MEANS THAT AN ACCEPTABLE COMPANION ANIMAL SAFETY STUDY FOR #2517-80 AND #2517-85 DOES NOT EXIST.
Without a doubt, Registrations #2517-80 and #2517-85 are the most dangerous pet spot-on products on the market today. They are also the only pet spot-on products on the market which contain a high concentration (40%) of a Type II pyrethroid.
Here is EPA's Cyphenothrin Summary Document for Registration Review:
Excerpt from page 14:
"There have been several reported pet incidents involving the use of cyphenothrin pet treatments on dogs. From January 2006 to November 2009, there were 149 reported mortalities, 367 major reported incidents, 13,455 moderate reported incidents and 32,713 minor reported incidents. From all reported pesticide related pet incidents, cyphenothrin products account for 10% of the total reported pet mortalities, 13% of all major incidents, 54% of all moderate incidents, and 65% of all minor incidents. Some of these incidents resulted from cyphenothrin products co-formulated with pyriproxifen, and it is unclear whether one active ingredient or the other, or an emergent effect from the formulation is responsible for these incidents." When you consider the fact that #2517-80 and #2517-85 are the ONLY cyphenothrin pet treatments for dogs, that is simply astounding.
According to EPA's residential risk assessments for cyphenothrin, Registrations #2517-80 and #2517-85 pose risks of concern to toddlers. However, even more alarming is the fact that those risk assessments were based on the original proposed label dosages, NOT THE LABEL DOSAGES THAT ARE CURRENTLY REGISTERED!
Here is the EPA's Human Health Assessment Scoping Document in Support of Registration Review for Cyphenothrin:
Excerpts:
"The toxicology database for cyphenothrin is not complete."
"Combined MOEs estimated for exposures to children from hugging treated companion dogs are of concern."
To see the dosages that were originally assessed for #2517-80 and #2517-85, and the dosages that are currently registered, please see page 15 of the above document.
There is another aspect of this matter that I find to be very troubling. Byron Backus, Ph.D. was one of the technical reviewers of the pet spot-on evaluation reports for #2517-80 and #2517-85. As mentioned above, Dr. Backus had direct involvement in the registration of these products, and was aware of the concerns outlined above. I urge the EPA to review
this matter.
Given the fact that the companion animal safety study and the residential risk assessment for #2517-80 and #2517-85 were based on incorrect dosages, and considering the astounding number of adverse incidents that are reported each year from the use of those products, I urge EPA to prevent further unreasonable harm to toddlers and pets by removing those products from the market, effective immediately.
Best regards,
James TerBush
Website Administrator
(Below is email that I sent to Kimberly Nesci at the EPA on 4/9/10)
Dear Kimberly,
[Above] is email that I sent to you on Wednesday. I am sending it again just in case you did not receive it the first time.
The seriously flawed decisions which led to the registration of #2517-80 and #2517-85 have deeply troubled me ever since I became aware of it. If you would care to comment on this matter, I would very much appreciate it.
Best regards,
James TerBush
Website Administrator
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Are Spot-on Flea and Tick Products Safe for your Kids/Pets?
On March 17, 2010, EPA announced the results of its year-long investigation of pet spot-on products, which it began due to a sharp increase in adverse incidents that were reported in 2008. Below are the EPA's evaluation reports for the following products:
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My dog, a 9 year old German Shorthair Pointer had 2 seizures after I applied Sergeant's topical flea prep to his skin as directed. The fleas died but within a day he had a sudden collapse and seizure late at night. He had to be carried into the house where he seemed in distress but resting. The next morning he seemed much improved but again before I could get him into the car for a trip to the vet he collapsed again, recovering within about half an hour.
At the vet's I told him I had used Sergeant's and the vet exclaimed "that stuff kills dogs: they should take it off the market." He recommended a very thorough shampoo (not a medicated one) and rinsing. I did so to get all the remaining chemical off the dog. He seems better now -- but it's only been a few days and the product assures that it can stay on even after shampoos.
Then I did a google search. The appalling news is that many people have had problems with
it including deaths. There may now be a class-action suit against Sergeants and the EPA is investigating. The company denies there are any problems. How can places like PetSmart and Petco still carry these products???? Also some supermarkets (where it is the only one offered).
My vet said Frontline and Advantix are safe -- different active ingredients.
Rick 4/9/10
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I am a K-9 handler and have been using Frontline for years without a problem. I recently switched to Advantix for my 3 year old Belgion Malinois because it also repels misquitoes
and I thought that would be great because I live in a country setting. I applied Advantix at about 8:00pm before I put my K-9 (Robbie) in his kennel for the night. The next morning
when I went to get him for work he was a mess, it almost looked to me like he had Bloat,
was lethargic and had major tremors. I rushed him to the emergency room where they checked him for Bloat. Once he was cleared of Bloat I then took him to my regular vet.
They ran tests and X-rays and found nothing wrong but yet MY Partner continues to have tremors and be very lethargic. I was told by BAYER to wash him in dawn dish liquid and
take him to my vet and they would not tell me any more than that. I for the life of me cannot believe this. I have since seen all the postings about this poison we are putting on our dogs and can't believe this company continues to sell this product. I applied this poison on my partner on 4/7/10 and as of today's date 4/15/10 he is still in a state of tremors and unable
to work even with all the medication he is on. I am sick about this will do everything in my power to make people aware of this nasty product.
Stephen
K-9 Unit Commander/Trainer
Rhode Island Department of Corrections
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(Below is email that Amy received on 4/15/10 - see Amy's post 3/3/10)
Hey there…my name is Joce Sterman. I’m a reporter with the ABC station in Baltimore (actually a colleague of Nicole’s – she works for one of my company’s sister stations).
We’re exploring this story as well as our colleagues in other markets…wondering if you’ve heard from anyone in Baltimore/DC about this?? We’d love to get someone local to tell
us more about their experiences with this. It’s truly heartbreaking!! If you want to post
another message on the board to let people know they can also contact me if they’re
from Maryland – that would be so incredibly helpful. Thanks!! Just distribute my email!!
Joce Sterman
ABC2 Investigators
Dear Ms. Sterman,
Thank you for taking an interest in this important issue, which affects not only pets, but the health of people, especially young children who are exposed to pets that have been treated with spot-on flea and tick products.
I hope that people living in the Baltimore/DC area who have pets that have been injured
or killed recently by these products will see this post and contact you. However, I do not believe that it is necessary for you to find "local victims" in order to warn your viewers of this potential danger.
For example, if you were aware of reports that a certain manufacturer's crib was harming infants, or that a certain model vehicle posed a safety hazard, would you immediately put
the story on the air, or would you wait until you could locate enough victims in your area?
If you let your viewers know about the dangers of spot-on flea and tick products now, I am
sure that many who see your story will contact you and be more than willing to participate
in a follow-up story.
James TerBush
Website Administrator
P.S. If you still believe that you need to find local victims to tell this story, the best way to
find them would be to contact veterinarians and emergency animal hospitals in your area. Also, since you are in the Baltimore/DC area, it would be very easy for you to arrange an interview with a spokesperson from the EPA regarding this issue.
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I have two adult large kitties. For the last 2-3 months, we have been using Bio-Spot on
them. This past Sunday, we put it on the cats. On Monday, the smaller one, TJ 12 pounds, had a very bad grand mal type seizure. My husband quickly recognized it and we rushed
him to the nearest vet. It came out that we had put the medicine on him the day before and the vet suspected that was the problem. Luckily for us, TJ recovered after two rounds of Valium, 2 units of IV fluids, bathing, activated charcoal, and an overnight stay at the vet.
When he returned home, he was very strange. He cried constantly, wanted 24 hour care,
ate ravenously ( I understand that was the Valium), and SEEMS to have made a complete recovery. ($157 later). Neither cat had ever had seizures, and were very healthy. My hope
for the other one is that he weighs more and tolerated it better. Thank goodness for a very astute veterinarian!
Pat 4/19/10
I did contact the company and they were very nice. They said that they would reimburse my vet bill and the 3 pack of BioSpot. Then they connected me to the Poison Control Center of the ASPCA, who also took down the information and gave me a case number. No one seemed surprised when I described TJ's symptoms. The company did ask for the vet's notes he made when TJ first arrived, so we will see how that goes tomorrow. (Of course, they also want a copy of the bill).
Pat 4/20/10
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The EPA has a website concerning its recent evaluation of pet spot-on products and its plan to make these products safer:
It states:
"EPA is committed to transparency and will offer continued public updates on EPA’s actions on pet spot-on pesticide products."
The above website has a link concerning a closed-door meeting which took place on May 5, 2009, between the EPA and the manufacturers of pet spot-on products:
The purpose of the meeting was to discuss the recent increase in adverse incidents that had been reported to the EPA, and the data that EPA would need from the product manufacturers to analyze these incidents.
I applauded the EPA for releasing the above meeting summary, however, it did so
only after I had filed a Freedom of Information Act request to gain access to it.
Recently, I became aware of two other closed-door meetings which took place last year between the EPA , the Consumer Specialty Products Association (an industry trade group), and the manufacturers of pet spot-on products. These meetings, which have not been disclosed by the EPA, took place on May 26, 2009 and September 10, 2009.
Below is information concerning these meetings, which I obtained under the Freedom of Information Act:
CSPA-1.gif is the August 11, 2009 e-mail from the CSPA to the EPA
CSPA-2.gif is the September 1, 2009 e-mail from the CSPA to the EPA
CSPA-3.gif is the September 10, 2009 meeting agenda from the CSPA
EPA-91409.gif is e-mail from the EPA to the CSPA
EPA-CSPA.gif is the sign-in sheet for the September 10, 2009 meeting
These documents do not provide much detail, and I am sure that other documents exist (including email), but just the fact that these meetings took place should be very troubling to pet owners because it shows that during the EPA's investigation of pet spot-on products, some stakeholders had access while others did not.
Here is a key excerpt from the August 11, 2009, e-mail from the CSPA to the EPA:
"CSPA and members have expertise in separating the 'wheat from the chaff'
when reviewing incident reports - a [sic] especially important skill, and since this
is a vitally important aspect of FIFRA regulation of pesticides and given our history of cooperation and involvement, we would like to be involved as you design the analysis, evaluate its results, and make any changes in the reporting process."
That level of involvement by the pet spot-on manufacturers is truly appalling, and
has not been acknowledged by the EPA.
Here is a report from the CSPA titled "Results for Industry 2009" which describes their involvement in arranging the above meetings with the EPA:
Excerpt:
"On April 16, EPA posted an Advisory Statement on its website regarding spot-on pet products that noted an increase in pet incident reports and stated EPA's intent to view such incidents with increased scrutiny. This was followed by an EPA meeting with spot-on product registrants on May 5, at which EPA announced its request for additional data on previously filed incident reports and a July 2009 deadline for submissions. CSPA arranged meetings with its members on this issue, and set up a meeting with EPA for May 26, at which CSPA presented registrants' concerns about the scope of the information being requested, the timeframe, and the uncertainty about what EPA planned to do with this data."
"Subsequent discussions with CSPA members and others affected by this notice led the Association to schedule a Sept. 10 meeting with the EPA Registration Director and other EPA staff to discuss the analysis of the data, EPA's plans for using the data, and to offer the expertise of CSPA and its members to help EPA generate useful information."
The close relationship between the CSPA and the EPA was also acknowledged by the CSPA last December in this press release:
On March 17, 2010, prior to releasing the results of its evaluation of spot-on products to the public, the EPA met with the product manufacturers to discuss the analysis and the risk mitigation plan. Here is the meeting summary:
Excerpts:
"The registrants had logistical questions about the schedule for the release of the findings and the rationale for the rigorous schedule. The registrant had questions about the timing for making the Agency's reviews and decisions available to the public."
"...The Agency explained that it was criticized for the May 2009 meeting with the registrants and, as such, it is releasing to the public as soon as possible after the registrant meeting the same information provided to the registrants to help eliminate doubts that the public may have about the impartiality of the Agency decisions."
Immediately following the meeting with the EPA, the CSPA issued the following press release:
Despite claims of impartiality and having conducted a transparent in-depth analysis of the incidents, there should be no doubt that the evaluation of spot-on products
by EPA's "expert team of veterinarians," WHO WERE ALL EPA EMPLOYEES, was
anything but impartial, transparent and rigorous. Industry insiders should not be
in charge of industry oversight.
***************************************************************************************
(Below is email that I received from the EPA on 4/26/10)
Thank you for your interest in EPA actions regarding increased restrictions in
the regulation of pet spot-on pesticides. Please see below our responses to
your questions.
1. Could you please let me know why the EPA did not attempt to quantify the
dose per pound to which pets were exposed? It would seem that would have
been extremely valuable data.
EPA, along with an external peer review group, conducted an in-depth
analysis of the incidents reported associated with pet spot-on pesticide
applications. Our expert panel determined which analyses would be the
most valuable in providing needed information to inform our regulatory
decisions. While we did not perform every possible analysis of the data,
we did evaluate incidents in relation to body weight and the product
weight range. In the future, we may quantify dose per pound of exposure
if we determine that is needed to investigate the margin of safety for
individual products.
2. Also, could you please explain what is meant by "we discounted the rare effects"?
Given the data we had from reported incidents, we could not determine if
rare effects were caused by the product or by something else, such as an
undiagnosed illness. So, in conducting a risk analysis, our result was much
more reliable by maintaining a focus on the more common effects, as these
are more likely to be caused by the product. By increasing restrictions for
these products based on the risk analysis, all effects, including common
effects and rare effects, should be diminished.
Kimberly Nesci, Special Assistant
Registration Division, Office of Pesticide Programs
U.S. Environmental Protection Agency
***************************************************************************************
(Below is email that the EPA sent to a friend of mine on 4/26/10)
Thank you for your interest in EPA’s actions on pet spot-on pesticides
and for your participation in our webcast meeting on March 17. We
appreciate your comments and are happy to respond to your questions.
Please see our responses to your questions below.
1. I attended the public webinar and reviewed the documents posted
today on the EPA website and I have a couple of questions. When I viewed
the data evaluations of the products posted on the website I was looking
for the percentage per doses sold of incidents for each severity code. I
did not find that. While I believe that it was said that the number of doses
sold of a particular product is proprietary information, revealing the
percentage of adverse reactions per doses sold does not reveal the
number of doses sold and therefore I do not see why this information
cannot be provided. This is, in fact, the most pertinent information for
anyone trying to assess a product's risk. The number of incidents is
meaningless to me if I do not know what percentage that is of dosages
sold. I am wondering why this information was not provided to the public
and whether or not it will be provided in the future. It seems to me that
providing the public with some meager means of comparing risk between
products would help to motivate the registrants to improve safety in order
to compete for market share. If percentage per doses sold of 2008
incidents for each severity code is something that may be obtained by
a Freedom of Information Request I would like to know the procedure
to follow to file such a request.
There is certain information that EPA cannot provide to the public
because it is considered “confidential business information.”
Number of doses sold falls into this category, as based on this
information a person could calculate market share of the companies.
In addition, percentage of adverse reactions per dose cannot be
revealed, as this information could be used to derive market share.
Even through FOIA, this information would not be available. If you
are interested in requesting information via FOIA, please follow this
link: http://www.epa.gov/pesticides/foia/. Please be assured that
the EPA will consider this type of information when making its
product specific regulatory decisions.
2. My next question is related to the packaging and dispensing of the
spot-on products. The products I have purchased from my veterinarian
are packaged in a box and the box contains either three vials or six
vials of the product. Does EPA require the products to be packaged
and sold in this manner as opposed to being packaged 500 in a bulk
container from which the seller can dispense the number desired? My
point in this is that the packages are commonly broken and less product
dispensed due to the customer's inability to pay for a whole pack. If this
is not supposed to be done someone needs to take action to stop it. If
it is allowable, someone needs to take action to ensure that the consumer
receives the product directions and warning information meant to be
included. Label revisions will not be effective if the label is not passed
along to the consumer. In my opinion it is not the consumer's responsibility
to ask the seller for this information nor is it the consumer's responsibility
to look this information up on the manufacturer's website. If the position
is taken that this is the consumer's responsibility, then someone needs
to undertake an education campaign to inform all pet owners that such
information exists and that they need to ask for it, read it, and assess
risk vs. benefit as generally it simply does not occur to most of them.
The pet spot-on pesticides are regulated by EPA. As part of
that regulation, the label must be provided with the pesticide.
The products may not be sold without the label, as that label
provides very specific information on dose, how to apply the
pesticide, ingredients and safety. We agree that this should
not be the consumer’s responsibility.
3. Third, if a particular vial of product consists of say 80% inert
ingredients is there any possibility that the active ingredients are not
evenly dispersed throughout the carrier? Is it possible that a vial could
be split and all of the active ingredient contained in one half? Of course
what brings this to mind is chewable drug tablets that cannot be halved
because all of the active drug might be in one side or the other.
Ingredients should be evenly mixed throughout the vials. EPA
knows of no incidence that resulted from this not being the case.
Applications not in accordance with label instructions are illegal.
4. Finally, the concern was expressed that some inert ingredients might
cause enhanced dermal absorption. Is my understanding correct that
the spot-ons are classified as topicals because they are supposedly
not systemically absorbed? Do you mean that some inert ingredients
readily absorbed by the skin could carry the active product with them
and therefore cause it to be absorbed systemically? If I am interpreting
incorrectly what is meant by enhanced dermal absorption and why it
would be a concern. Could you clarify this for me?
Spot on pesticide products are topical because they are applied
on the surface of the pet’s body rather than taken internally. Some
of the ingredients may absorb into the system but the product
works by the pesticide presence on the surface, not in the body.
There is the possibility that some inert ingredients can act as a
carrier for the active ingredient and could result in enhanced
dermal absorption that contributes to toxicity in the pets. We
will be pursuing this possibility on an individual basis with the
registrants. This could possibly result in formula changes and
EPA disallowing specific inert ingredients.
Kimberly Nesci, Special Assistant
Registration Division, Office of Pesticide Programs
U.S. Environmental Protection Agency
***************************************************************************************
Here is the EPA's Analysis and Mitigation Plan for Pet Spot-on Products:
The above slide presentation was shown during the EPA's public webinar
on March 17, 2010.
***************************************************************************************
(Below is email that the EPA sent to Richard on 4/26/10)
Thank you for your continued interest in EPA's actions regarding pet spot-on
pesticides. We appreciate your ongoing communication as you work to advocate
pet safety and we remember the story of your dog from last year. It was situations
like yours last year that caused EPA to analyze adverse incidents associated
with the use of pet spot-on pesticides.
Given our analysis, we have begun to take action to increase restrictions of
these products, review individual products with each registrant, and clarify the
labels on both dog and cat products to improve consumer understanding.
Having participated in our recent webcast meeting, we know you are aware
of these steps we are taking.
We hope that you see that we are paying attention to the public concern,
stories and emails. We are responding through scientific analyses and
risk management decision-making. We thank you for your understanding of
our process and your kind words that reflect this understanding.
Please see our responses below to questions you recently submitted.
1. Do I understand correctly that the EPA will begin implementing Pre-Market
Clinical Trials and Post-Market Surveillance similar to the FDA process? If so,
when will that begin? If I'm confused on this could you please clarify for me?
You understand correctly that EPA is planning to change its guidelines
and require pre-market clinical trials. In addition, the Agency plans
to implement a more formalized post-market surveillance program by
requiring standardized incident reporting information for spot-on
products, rather than aggregate summaries. We have posted this
and other actions as part of a mitigation plan in a public docket
R=EPA-HQ-OPP-2010-0229 and we have requested comment from
the public. Comment period will close on May 17, 2010. After the
comment period closes, EPA will review and respond to the comments
and make a determination based on the comments, our scientific
analyses, the laws, and other relevant factors. In order to fully
implement this change in our guidelines, further regulatory process
is needed, potentially including an additional public comment period.
The Agency plans to follow its formal processes to make changes
in the long term. In the short term, the Agency is discussing individual
product registrations with the registrants and will work to impose
these and other requirements on a case-by-case basis. We intend to
keep the public informed throughout this process.
2. Product manufacturers/registrants have long (and loudly) stated that the
majority of the adverse incident problem is based in pet owner misuse or
misapplication of the products. I sensed that your review turned up many
examples of misuse but you do not necessarily believe this is the systemic
problem--is that correct?
Misuse was responsible for the majority of incidents reported for some
products. Misuse, however, was not the sole cause of adverse effects.
We noticed that the level of misuse varied among products. Part of the
actions we are taking, therefore, have to do with the labels on products
and the clarity of directions for safe use.
3. The ASPCA is one of many sources of your information. I revere most of
the work being done by the ASPCA, however, their organization APCC (Animal
Poison Control Center) which provides much of the adverse incident data you
indicated that you use (among other data they provide you), has a consulting
services relationship with some of the product manufacturers of these spot-on
products. The APCC provides the manufacturers not only with adverse incident
data, but also legal cases consultation, formulation issues, product liability,
biosurveillance and other consulting services for the manufacturers/registrants.
All of this information is available on the ASPCA website under
www.ASPCA.com APCC consulting services. This represents a financial
relationship. This relationship has been called into question in terms of
potential or perceived conflict of interest. Is the EPA aware of this relationship
and how has the APCC convinced the EPA that the information conveyed from
them to the EPA is objective and does not unfairly represent the manufacturers
economic interests? I believe these two questions are important as you consider \
data accuracy, objectivity and scientific efficacy.
APCC prepared a report for Registration #2517-80 in a format which we
requested. This report provided valuable information that was confirmatory
for data submitted by the registrant which we analyzed. We were able to
verify the APCC data because raw data was also submitted. The APCC
reports contained only factual information and did not editorialize or
express opinions. EPA is aware that APCC collects and reports data on
incidents for several pesticide manufacturers, as well.
4. Can you provide me with the EPA website access to the incident reporting data?
There are several steps one can take to report adverse incidents. We are
pasting in the information from our web page below. You can also follow
the link to this site:
EPA recommends that veterinarians use the National Pesticide Information
Center's Veterinary Pesticide Adverse Effects Reporting portal to report
incidents.
Pet owners can report incidents through several routes:
Tell the Registrant: Pet owners should always report adverse effects to
the product registrant. Pesticide manufacturers are required by law to
report incident information to EPA. Contact information can be found on
the product label. Clearly identify the name of the product used, the EPA
Registration Number, the type and breed of animal affected, symptoms
observed in the pet, and any other details pertaining to the incident.
Tell EPA: Forward the information in our "ask a question" site:
Go to the Pesticides Frequent Questions Web page
Select "flea and tick" in the drop-down box
The question that will give you the information about reporting
an incident will be the first question.
Tell Your Veterinarian: Veterinarians have access to a reporting
mechanism called the Veterinary Pesticide Adverse Effects Reporting
portal to report incidents. This portal is not for use by the public.
Tell the National Pesticide Information Center: Call 1-800-858-7378
to report an incident
5. I'm still a little unsure of the timelines of your Risk Mitigation actions. I
realize each action will have different timing but would it be possible to get
a more specific timeframe of your actions? As you might expect, my sense
of urgency might far outstrip your ability to make objective, scientific, fact
based decisions.
As described above, there is a set method for creating or modifying
guidelines at EPA. We propose actions in the Federal Register, open
a "docket" for receiving and sharing information, offer a set time for
public comment, review and respond to comments, and then make a
final decision, publish that in the Federal Register and include in that
a starting date. It is not something we can do overnight but we are
moving expeditiously on this. At the same time, in the case of pet
spot-on pesticides, we are meeting individually with the registrants
to discuss specific products and product-specific mitigation actions.
6. I realize that your work focused specifically on cats and dogs and not
humans. Who has responsibility for the potential health implications and
risks to infants, toddlers and pregnant women? I believe you gave the
name of one particular individual ("Wade Britton" sp.) during the webinar.
EPA registers pesticides based on risks and benefits to human health
and the environment. As is done for all pesticide products, EPA is
responsible for ensuring the safety of the pet spot-on products. This
means the safety of both the animal to which it is applied and to humans
who may come into contact with the pesticide. EPA conducts risk
assessments that take into account human health and, in particular,
child health. We assess the safety of the person applying the pesticide,
as well as people coming into contact with the animal after the application.
EPA scientists estimate the amount of applied pesticide that can transfer
from the animal to an adult or child's skin from hugging or otherwise
contacting an animal treated with a spot-on product. Based on these
estimates, EPA ensures that adults and children are protected from
exposure to pesticide treated pets. EPA makes registration decisions
for these products based on both human and pet safety.
Kimberly Nesci, Special Assistant
Registration Division, Office of Pesticide Programs
U.S. Environmental Protection Agency
(Below is email that Richard sent to the EPA on 4/29/10 in response)
Dear Ms. Nesci,
Thank you for your responses. It's obvious that my questions were treated
seriously and there's no question in my mind that you and the EPA continue
to take this issue very seriously.
Here are some specific reactions and a few more questions that I would
appreciate you addressing:
I was pleased with the depth and substance of your office's response to
Question 1.
Regarding Question 2--frankly I'm more concerned today than I was prior to
your response. As I mentioned in my question, I sensed on the webinar
that the EPA was not convinced that "misuse" was the major factor in
adverse effects. Label change requirements have been implemented many
times by the EPA. One registrant was required to make label changes on 4
different occasions (multiple products) in past years and the results have
been unsuccessful. That registrant finally had a product cancelled by the
EPA in 2005, but only after many more animals were injured or killed and
families emotionally and financially impacted. Other registrants have
been required to make label changes and the results have been no
better--in fact, as you well know, adverse incidents continue to rise
unacceptably. Label changes have proven to be only marginally effective
at best and the EPA has the data proving that fact. Additionally, there's
also an implication when requiring label changes that the consumer and pet
owner is not that smart. Frankly, label change action is nothing more
than kicking the can down the road. It buys more time for the registrants
and manufacturers to continue the same behavior and make available the
same dangerous ingredients. I sincerely hope the EPA's actions equate to
more depth and substance than marginal actions like label changes that
have demonstrated ineffectiveness for many years. If label changes were
required in times past when adverse incidents were at much lower levels
than why would the EPA believe more label changes would be the answer
today when adverse incidents have risen dramatically?
I sensed that you were not at all comfortable with Question 3 regarding
the ASPCA's relationship with the pesticide manufacturers through their
Animal Poison Control Center's Consulting Services organization. I do not
expect you to elaborate any further although I would have been pleased if
you not only confirmed your awareness of the financial relationship
between the APCC and the pesticide manufacturer/registrants, but also
acknowledged the fact that the ASPCA/APCC has consistently stated that the
ingredients phenothrin, cyphenothrin, permethrin and other pesticide
ingredients "would not be expected to cause adverse incidents" in puppies
and dogs. The quotations are theirs. (Incidentally, the ASPCA was taking
the same medical position regarding the impact of synthetic pyrethroids on
cats and kittens as recently as 2005 at which time medical science
clearly, and finally, demonstrated the toxic impact of pyrethroids on
cats). Because of this position, the ASPCA's Animal Poison Control
Center will typically not agree with pet owners about the cause of the
incident and certainly will not document the incident as product caused.
In turn, the incident is not reported to the registrant/manufacturer and,
of course, they in turn will not report it to you as raw data.
This is a serious issue. There's no question about a conflict of
interest. I've personally confirmed this in a conversation with Melissa
Norden, senior vice-president and chief of staff, ASPCA. Raw data from
the registrants to the EPA is many times a product of information provided
to them by the APCC which has refused to acknowledge the product's full
potential for adverse effects. I would ask that you do not take my word
for it--thoroughly investigate this issue and confirm it for yourself. Information
and data provided the EPA by the ASPCA's Animal Poison Control
Center must be viewed skeptically and verified for complete accuracy.
Thank you for your very complete response to Question 4.
In your response to Question 5, you wrote that "in the case of pet spot-on
pesticides, we are meeting individually with the registrants to discuss
specific products and product-specific mitigation actions." Are the
details of those meetings available to the public?
I appreciate your response to Question 6, but many of the EPA's own
documents have expressed serious concern for the potential of adverse
effects on toddlers and children (and pregnant women) from spot-on
pesticide ingredients. There is much EPA registration and re-registration
eligibility documentation indicating a lack of data proving adequate
safety margins not to mention medical science demonstrating unacceptable
risks associated with these pesticide product ingredients. This
particular issue is so concerning that it deserves its own narrow focus in
a separate letter that I will be preparing and submitting to the EPA.
Thank you, again, Ms. Nesci for your responses. I know that your
veterinarian staff and others may have contributed and I would appreciate
it if you would convey my appreciation. Thanks also, in advance, for your
responses to my comments and questions above.
Sincerely,
Richard
***************************************************************************************
(Below is email that I sent to the EPA on 4/27/10)
According to EPA's Evaluation of Spot-On Pet Products - Analysis and Mitigation Plan,
inert ingredients "may be of health concern as some inert ingredients result in enhanced dermal absorption" of the active ingredient(s), which would contribute to the toxicity in pets.
Would that enhanced dermal absorption also apply to humans, especially toddlers, who
may touch or hug a recently treated pet? If so, shouldn't EPA residential risk assessments consider the risk estimate of toddler exposure to spot-on formulations, not just individual active ingredients?
Sincerely,
James TerBush
Website Administrator
***************************************************************************************
Yesterday, 4/27/10, at 4:00 p.m. , my husband applied BioSpot Flea Medication down
the back of my 15 lb Rat Terrrier's back. About 7:15, Hershey began acting strange. She became extremely agitated and got on the back of the couch (which she has never done),
and began pacing back and forth. My husband called me downstairs to see if I could figure out what was wrong with Hershey. I coaxed her off the back of the couch and she sat next to me, but refused to lay down. Her breathing was very shallow and irregular. She sat next to me for about 2 minutes then started pacing the floor, jumped back onto the back of the sofa and started pacing again. I immediately thought of the flea medication, because this was the first time we did not purchase from the veteranarian. I looked BioSpot up on the internet, and choose your site to review. I was appalled to see that her symptoms were listed on your site and after reviewing the medication box, that one of the ingredients was also listed on your site as to be avoided. My husband and I put Hershey in the tub and bathed her twice using Dawn (thank goodness we had it in the house). We watched Hershey all night, and she seems to
be ok now. Hopefully we caught this in time. I cannot thank you enough for your diligence in posting and maintaining this site. I have let all my FaceBook friends know about the adverse effects of BioSpot.
Patricia 4/28/10
***************************************************************************************
(Below is email that I sent to the EPA on 4/30/10)
Dear Ms. Nesci,
Thank you for responding to my questions concerning the EPA's evaluation of pet spot-on products. I have some questions concerning the health risk to humans, especially infants and children, when they are exposed to pets that have been treated with these products, and would very much appreciate your response.
The EPA's expert veterinary team found that some spot-on products had a number of narrow dose ranges to cover the range of small dogs to heavy dogs, while other products had fewer and wider dose ranges, resulting in larger doses per pound for dogs at the bottom of each dose range, particularly so for dogs receiving product labeled for the smallest dogs. However, for all spot-on products, the dose per pound that is delivered to dogs at the bottom of each dose range is typically two-fold to six-fold greater than the dose per pound that is delivered to dogs at the top of each dose range. The team found that larger doses within certain product's dose ranges correlated with increased risk and severity of pet incidents. These larger doses also pose increased health risks to humans, especially infants and children who pet, hug, and sleep with treated pets. EPA's residential risk assessments fail to consider the fact that infants and children are being exposed to a two-fold to six-fold increase in dosage. Residential risk assessments have shown that spot-on products at 1X the application rate are already one of the most dangerous residential pesticide exposure scenarios for toddlers -- bordering on unacceptable risks of concern. Is the EPA concerned that infants and children are being exposed to a two-fold to six-fold increase in dosage from these products, and does it have any plans to reassess the risk to toddlers that comes from exposure to dosages that are up to six times greater than what has been previously assessed by EPA's residential risk assessments?
I would also like to know why permethrin-based spot-on products were not included in EPA's residential risk assessments until 2006 (despite being on the market since 1990), and why phenothrin-based spot-on products were not included in EPA's residential risk assessments until 2008 (despite being on the market since 1999)? Is it possible that such glaring omissions were due to careless oversight?
When EPA finally did a risk assessment for permethrin-based spot-on products, it relied solely upon a dislodgeability study (see attached file) that was submitted by Bayer in 2006 during the reregistration of permethrin. As you can see in the attached file, the primary reviewer (Versar, Inc.) and EPA's Health Effects Division both raised serious concerns about the study, which should have led to it being classified as "unacceptable." Does the EPA believe that this poorly designed study is adequate for assessing the health risks that spot-on products pose to toddlers? If so, please provide a detailed explanation.
Likewise, when EPA finally did a risk assessment for phenothrin-based spot-on products in 2008, the initial deterministic risk assessment indicated significant risks of concern for toddlers. A subsequent probabilistic risk assessment also found significant risks of concern for toddlers. Instead of ordering risk mitigation to protect toddlers, EPA expeditiously "refined" the risk assessment using a Benchmark Dose Analysis that was provided by registrants. The further refined assessment indicated no risks of concern. Given the fact that the toxicological database for phenothrin is incomplete, and that EPA recently determined that developmental neurotoxicity studies do not provide sufficient information related to the susceptibility of infants and children, does EPA believe that the health of our nation's infants and children was best served by the refinement of the risk assessment for phenothrin?
Thank you in advance for your response.
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.
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