Message Board
March 2010
Comments must be submitted by 5/17/10. For more information, click here.
Should the EPA have stricter regulations for flea and tick products,
including requiring pre-market clinical trials, post-market surveillance,
and more comprehensive companion animal safety studies?
The pesticide industry doesn't think so!
The EPA wants to hear what YOU think. To submit comments, click here.
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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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CONSUMER ALERT
Are the rats jumping ship, or is the EPA tossing them overboard?
EPA recently announced that it has received applications from several pesticide manufacturers (including Hartz, Sergeants, Adams, and Farnam) to voluntarily cancel
hundreds of household pesticide products, including flea and tick shampoos, flea and tick
powders, carpet dust/powders, insect foggers, flying insect sprays, ant and roach killers,
and garden insect sprays. Most of these products contain pyrethrins and pyrethroids (resmethrin, permethrin, phenothrin), and synergists (piperonyl butoxide, MGK 264).
For a complete list of products, go to:
The cancellation of these products coincides with several recent decisions by the EPA concerning the fate of pyrethrins and pyrethroids. Last year, EPA finally acknowledged
that pyrethrins and synthetic pyrethroids share a common mechanism of toxicity and, therefore, need a cumulative risk assessment.
The FIFRA Scientific Advisory Panel (SAP) met on June 16 - 18, 2009, to consider and review an evaluation of the common mechanism of action of pyrethroid pesticides.
EPA has also recently determined that developmental toxicity studies (DNTs) previously required for pyrethroid insecticides do not adequately characterize potential susceptibility of infants and children.
Here are two letters recently sent by the EPA to pesticide product manufacturers:
Here is an EPA memorandum concerning developmental neurotoxicity and pyrethroids:
Despite longstanding concerns that exposure to pyrethrins or pyrethroids may aggravate asthma or lead to asthma-like symptoms, EPA refuses to require precautionary labeling warning users and the medical community about the potential
of asthma or allergic reactions in sensitized individuals, especially those with
preexisting respiratory disease:
Unfortunately, the EPA will allow product manufacturers to make these products for another year, and will allow retailers to continue to sell them until their shelves are empty.
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(Below are several emails that Richard sent to the ASPCA concerning their corporate
consulting services)
October 12, 2009
Dr. Steven R. Hansen
Senior Vice President
ASPCA Animal Poison Control Center
1717 South Philo Road
Urbana, Illinois 61802
Dear Dr. Hansen,
Over the last 18 months--specifically the first few months of that timeframe--you and I exchanged a phone call or two and several emails. You were immensely helpful to me with your advice and encouragement as I asked many questions regarding topical over-the-counter flea and tick products containing pesticide ingredients. You were most generous with your time. My concern, as you may recall, was the tremendous number of adverse health incidents that were being reported to your organization, the Environmental Protection Agency, The National Pesticide Information Center and other regulatory agencies, as well as to the manufacturers of these products. I was also--and still remain--concerned about the number of injuries and deaths that go unreported. As you will remember, my focus on this issue developed from our own personal tragedy as a result of the use of one of these products.
I sensed in the tone of your last one or two emails that you were not particularly delighted with some of the issues I was raising as I continued to do my research with academicians, regulatory agencies, veterinarians and veterinary specialists, combined with interaction with the media. In fact, I've received no response whatsoever to the last two issues that I brought to your attention. I realize--at your level--you have tremendous responsibilities and obligations to deal with every day, so I am not complaining and I sincerely appreciate the time you originally gave me. On the other hand if I did do something to offend you I completely and sincerely apologize.
However, I'm now bringing another issue to you--it's a serious one, and I respectfully and politely ask that you do take the time to respond with the clarification that I believe is important.
I have read on multiple websites and spoken with individuals where the following statements have been made: the American Society for the Prevention of Cruelty to Animals (ASPCA) Animal Poison Control Center (APCC) has a financial arrangement with several manufacturers of pet pesticide products, which pay the ASPCA to manage their adverse incident claims, and (APCC website commentary) "provide extensive veterinary toxicology consulting on legal cases, formulation issues, product liability, regulatory reporting, and biosurveillance."
Several people have reported in the media and on websites that when they called the ASPCA Animal Poison Control Center to report a severe adverse reaction in their dog or cat from a flea and tick product, they were advised by the APCC's veterinary staff that flea and tick products containing pesticide ingredients would not cause severe adverse reactions in cats or dogs if applied according to label directions--they only cause severe adverse reactions when misapplied, i.e., wrong dosage, dog product applied to cats, debilitated or aged animals, animals with predisposed illness, etc.
In fact, Dr. Hansen, the manufacturers are enthusiastically using some of your own recent media quotations regarding the safety margins of these products. They point to you as a highly credible source whose expert opinion is that adverse effects of these pesticide products are extremely rare when used properly and the products are highly effective in dealing with the alternative health risks associated with fleas and ticks. Some veterinarians have written that they are surprised by your temerity in speaking about the risks associated with pesticide products.
Would you please clarify this. During our telephone conversation (that was in April of 2008, so my recollection may be faulty) I had a completely different impression than the one I'm now reading on websites, other media outlets and conversations with individuals. As an example, I recall you saying that the ASPCA/APCC had discontinued accepting advertising dollars from pet product manufacturers precisely to avoid even the appearance of a conflict of interest. In fact, that is precisely what I have been communicating to people. I have been saying that you have no financial arrangements whatsoever with the product manufacturers of topical spot-on over-the-counter flea and tick products. Am I wrong?
Does your organization have a financial arrangement where you work directly with pet product manufacturers, including Hartz Mountain, Sergeant's, Central Life Services, Merial, Bayer or any others in the business areas stated on your website--managing adverse event cases, provide veterinary toxicology consulting on legal services, formulation issues, product liability and regulatory reporting? Do you perform these activities--for a fee--for any manufacturers of flea and tick products? What type of regulatory reporting does your organization perform? What regulatory agencies?
I'm asking these questions because I want to deal with facts. As you know, I'm not a supporter of these products or the manufacturers that distribute them. I believe they have done tremendous damage to animals and families and continue to do so. I continue to work with the EPA , other regulatory agencies, the media, the product manufacturers and retailers in an effort to have these pesticide products reformulated to the safer alternatives. I am, however, a supporter of the ASPCA and APCC and highly respect the work you do. If the statements above are incorrect I will do everything I can to help correct and/or clarify the misinformation and communicate the facts. If the statements above are correct I will be disappointed but my objective--reformulation to safer alternatives--will not be changed. However, I would like you to provide me with those facts, if you would please.
Thank you in advance for your time. If you would prefer to have a discussion on this subject please feel free to call me--I'd be delighted to speak with you again.
Sincerely,
Richard
----- Original Message -----
From: Rich
To: StevenHansen@aspca.org ; edsayres@aspca.org
Sent: Thursday, November 12, 2009 2:29 PM
Subject: ASPCA/APCC Business Relationships With Pet Product Manufacturers
Dr. Hansen:
I'm very disappointed. Not as much over your dismissiveness of me and my requests--that's certainly your prerogative--but, more importantly, by what I've confirmed from your
staff over the last week. Specifically, the relationship the APCC has with corporations whose products are documented as causing damage to animals and whose products
are under scrutiny by federal regulatory agencies.
If you had demonstrated the simple courtesy of a response it's possible I may have
learned details that would have put this issue in a different perspective. However, the specifics your own staff provided are disappointing to say the least and confirm the allegations of conflict of interest I've read and heard from other sources.
Over the years I've revered much of the work your organization does. Most people feel
the same. The ASPCA/APCC does outstanding work serving families and companion animals in many areas. However, the public will be tremendously disappointed as they become aware of the financial relationship you've developed with these corporations through your consulting services function.
It's not wrong for you to be engaged in this financial relationship. It is wrong, however, to
be engaged in this relationship while publicly defending the safety margins of topical spot -on over the counter flea and tick products. You have even been quoted as establishing a false singular choice between the "minor risks" of their use versus serious health issues associated with fleas and ticks if they are not used. In these media quotes you fail to mention the safer alternatives available today.
These pesticide products have been documented over many years to do much harm. Some, like Hartz Mountain's cat and kitten products have been cancelled for sale by the EPA. Additionally, the EPA has forced Sergeant's, Hartz, BioSpot and others to make labeling revisions and other cautionary safety steps. Yet you continue to lend the significant credibility of the ASPCA to the defense of their use, while in parallel benefitting from the "consulting services" you provide some of the companies. Your actions certainly project--
at a minimum--the appearance of a conflict of interest.
As you, or any of your veterinarians, continue to be quoted in the media--or any other
place for that matter--stating these products present "minimal risks to pets when used as directed", or "we don't have very many cases of true neurological issues when these products are properly used" (your quotes), the media and the public will quickly be made aware of the facts. The documented adverse incidents will be brought forward, along with safety actions taken against these products over the years by the EPA and state regulatory agencies. Additionally, the opinions of veterinary and veterinary toxicology experts that do not share your defense of pesticide product use on companion animals will be brought forward. Your recent defense of pesticide products will be rebutted with the facts. Those facts include your business relationships with the product manufacturers.
I'll never understand how this relationship between the EPA, the flea and tick product manufacturers and your organization has morphed into a monolith that protects and supports each other at the expense of companion animals, families and the environment. It's disgraceful.
The good news is that the public--particularly cat and dog owners--now has a greater level of knowledge, interest and activism on this subject than ever before. Animal owners, media and veterinarians and veterinary academicians of integrity, combined with the internet, have made this possible. This includes enlightenment about organizations and individuals who have a financial interest in protecting this terrible legacy.
Sincerely,
Richard
----- Original Message -----
From: Rich
To: presidentsoffice@aspca.org
Sent: Friday, February 19, 2010 2:56 PM
Subject: ASPCA/APCC Business Relationships With Pet Product Manufacturers
Mr. Edwin J. Sayres
President and CEO, ASPCA
424 E. 92nd Street
New York, N.Y. 10128-6804
presidentsoffice@aspca.org
Dear Mr. Sayres,
On November 12, 2009, I copied you on a letter that I forwarded to Dr. Steven Hansen (please see below). Since I have not received a response it's my assumption that you never saw of copy of this letter or the attachment of a previous letter (also below) I wrote to Dr. Hansen on October 12, 2009, that also went unanswered. It's my assumption and expectation that an organization like the ASPCA would promptly and professionally respond in kind to my letters.
I would sincerely appreciate a response from you after the opportunity to review the attached letters. Since they are both somewhat lengthy I'll make this one brief. I would simply and directly ask the ASPCA to respond to information brought to my attention from a member of your staff. Please confirm and/or explain--does the ASPCA, through the APCC's consulting services function, have a primary or secondary financial relationship with the product manufacturers and/or distributors of topical spot-on flea and tick products?
I'm sure you can understand, based upon my comments and questions in the attached letters, why this issue needs to be completely transparent, honest and open.
Thank you.
Sincerely,
Richard
(Below is email that Richard received from the ASPCA on 3/1/10)
----- Original Message -----
From: presidentsoffice@aspca.org
To: Rich
Sent: Monday, March 01, 2010 11:53 AM
Subject: Re: ASPCA/APCC Business Relationships With Pet Product Manufacturers
Dear Mr.
Your letter has been received. You will be sent a response shortly.
Best regards,
[deleted]
Assistant to [deleted], SVP & Chief of Staff
I wrote the ASPCA this morning asking when I would receive the response they
committed to nearly three weeks ago and this is what they sent:
I'm incredulous! This is unbelievable in its arrogance and condescending tone.
Richard 3/19/10
Thank you, Richard. I think pet owners would be outraged to find out about the financial
ties between the ASPCA and certain pesticide product manufacturers, especially if they had been advised by the ASPCA Animal Poison Control Center that their pet's death or illness had nothing to do with a pesticide product that was covered by the APSS.
James TerBush
Website Administrator
Hi Jim,
I just had a lengthy conversation today with [deleted], vice president and chief of staff of the ASPCA.
A 40 minute conversation confirmed that there definitely is this relationship we've known about. I believe an objective outside observer would easily see the conflict of interest but
Ms. [deleted], while not denying it, believed it not to be a problem. She defended Dr. Hansen's integrity, credentials, world-wide recognition and contributions. She's worked
with him for nearly 10 years and she extolled his virtues and stated she "stands with him". She recited lengthy examples of the great work done by the ASPCA and Dr. Hansen with
the FDA and the pet food recall issue as an example of the objectivity of the ASPCA. She stated that the ASPCA and APCC have declined financial gain because they could not support certain products of pet care manufacturers, with particular emphasis on the pet
food issue.
She simply indicated that Dr. Hansen and the APCC have a different scientific view of
the science surrounding the safety margins of the over the counter flea and tick pesticide products. She believes it's acceptable for Dr. Hansen to speak in defense of the safety margins while having a "relatively small" financial relationship with the product manufacturers. She defends this position on the basis of the good work the APCC does in learning more and more about these products and their product safety and efficacy--knowledge gained
only through these relationships.
I couldn't disagree more and made my feelings crystal clear. I told her that I would let
others--the media, pet advocates, veterinarians, veterinary academicians, etc., make their own decisions on the relationship. I told her I was attempting to give Dr. Hansen and Mr. Sayres the opportunity to clear up any disinformation and misunderstandings, yet Dr. Hansen chose to ignore my letters and the letter from Mr. Sayres completely ignored my question. Incidentally, she reluctantly agreed that Sayres' letter did not address the issue, but was simply a boilerplate response describing their role.
Ms. [deleted] did not realize that Dr. Hansen has never responded to my emails on this
issue. She was under the impression he had and that he and I had a difference of opinion over the science. She seemed a little surprised when I corrected the facts, but it didn't make any difference in her defense of the APCC's position. She was polite and patient but simply defended the consulting services relationships combined with Dr. Hansen's many media statements defending the products' safety margins.
I told her that she and I would agree to disagree. I also let her know that I would be informing as many other interested parties as I could about the issue and let them make their own judgments. Hopefully, as more people become aware of this relationship, clearer minds in the ASPCA will reconsider either the APCC's financial relationships with the product manufacturers or the strong public defense of these products with pet owners, consumers, veterinarians and the media.
Thanks, Jim. I wish I could have made more progress.
Rich 3/25/10
Thank you, Rich, for taking the time to speak with the ASPCA, and for providing them the opportunity to explain their position and clear up any misunderstandings that we may have had on this matter.
If their financial relationship with pet pesticide manufacturers is "relatively small", it would
not be a hardship if they ended it. I wouldn't have a problem if Wal-Mart, McDonald's, or FedEx sponsored the ASPCA Animal Poison Control Center. But taking money from pet pesticide manufacturers in exchange for litigation support of their pesticide products is indefensible.
If the ASPCA truly believes there is nothing wrong with having pet pesticide manufacturers sponsor its Animal Poison Control Center, they should acknowledge that support on their website, just like the Companion Animal Parasite Council does on its website:
James TerBush
Website Administrator
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About Sentry Pro XFC, THIS IS STILL HAPPENING!!!!
My dog had the same reaction as yours. I contacted our local news station
and they are interviewing me for a story on it 03/08/10. Yes, news exposure
for this horrible stuff!
I need more people to share their experiences. You do NOT have to be on
the news. Just please contact the reporter doing the story and tell her what
happened to you (and if you have any video of your pet reacting, that would
be awesome) The more people the reporter hears from, the more credible
the story will be.
Here is how you can contact me, and the reporter (put Sentry Pro XFC in
the subject line)
News Reporter: Nicole Longhini nlonghini@abc15.com
Me (Amy): bansentrypro@aol.com
Thanks!
Amy 3/3/10
UPDATE: I wanted to let you know that we have a tentative air date for our story here
in Phoenix. It should air on 5/11 at 10pm. I will let you know if anything changes.
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(Below is a letter that I submitted to the EPA on 3/5 concerning the receipt of requests to
voluntarily cancel certain pesticide registrations, including several flea and tick products)
James TerBush
Website Administrator
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PUBLIC ANNOUNCEMENT
EPA to Host Public Webcast on Its Evaluation of Pet Spot-On Products
Wednesday, March 17, 2010
Two-hour audio Web broadcast
Eastern: 4:00 pm – 6:00 pm 
Central: 3:00 am – 5:00 pm
Central: 3:00 am – 5:00 pmMountain: 2:00 pm – 4:00 pm Pacific: 1:00 pm – 3:00 pm
Pacific: 1:00 pm – 3:00 pmLast spring following a significant increase in incident reports associated with pet spot-on products in 2008, EPA received additional information from the pet spot-on pesticide registrants and conducted an intensive evaluation of those incidents and products. During this Webcast, EPA will present an overview of its evaluation of these products and its plans to further protect pets. The public will have an opportunity to submit questions and the EPA presenters will address as many as time allows.
The Webcast is free and preregistration is not required to participate. The Webcast will be held March 17, 2010 from 4 pm to 6 pm Eastern Daylight Time. All you will require is a computer that can play sound to attend this Webcast.
Participants should register with On24 (EPA’s Webcast vendor) using the link below. After registration be certain to test your system—you can see the test link after you register for the event. Once you click the link a small window will open and check your configurations. Once you have passed this configuration you will be able to view the Webcast.
You will receive two reminders about the Webcast: one that is 24-hours prior to the event and one that is 2-hours prior to the event. Both of these e-mails will include a link to the Webcast viewing platform. Additionally, you can use the registration link below to access the Webcast.
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(Below is email that I sent to Kimberly Nesci at the EPA on 3/12/10)
Dear Ms. Nesci,
Thank you again for letting us know about the public webcast next week. I am looking forward to it. Can you please let me know how long this webcast has been planned and what the Agency intends to do to publicize it? Thanks.
Also, it has come to my attention that the Consumer Specialty Products Association met with the EPA Registration Director and several other EPA staff members on September 10, 2009, to discuss the analysis of the spot-on incident data, EPA's plans for using the data, and offered to help the EPA generate useful information from it. This meeting was a follow-up to a meeting which was held on May 26, 2009, at which the CSPA presented registrants' concerns about the scope of the information being requested and uncertainty about what EPA planned to do with this data, which I also was not aware of. Neither of these meetings are mentioned on the EPA's "Increased Scrutiny of Flea and Tick Control Products for Pets" website. When we spoke on December 22, 2009, I had asked you if the registrants or their trade groups had any private discussions with the EPA concerning this issue (other than the meeting on May 5, 2009), and you assured me that they had not been involved in the process. Frankly, I am deeply troubled by this because we have not been provided the same level of access.
The above mentioned meetings with the CSPA were not open to the public, however, it is standard practice for EPA to prepare a summary of closed-door meetings and place it and meeting materials in the docket for the public to view. Can you please let me know how I can access this information, or would it be possible for you to provide links to it on your website (as was done for the May 5, 2009, meeting with registrants)?
Sincerely,
James TerBush
Website Administrator
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I have 3 Chihuahua's. My oldest, 7 year old, 17 lbs CHI-Dachshund Mix has a severe reaction to any topical flea and tick medication given to him in the past just under 5 years we have had him. He starts twitching, and gets very nervous, and he will go and hide or want to stay in our arms. He also has heavy, nervous breathing for long periods of time after using these products. These symptoms stay for days and at times up to a full week - during these episodes he is just not normal. It is very obvious he is in distress.
I no longer give him topical medication and he takes oral medication now and is much happier. I have used Bio Spot, K9 Advantix and Advantage in the past and his reaction is the same with all of them.
My middle Chi 5 years old, 11 lbs has a slightly nervous reaction and tends to get more nervous then normal and is slightly shaky and clingy. He too is now on oral flea and tick medication.
My youngest Chi, 3 year old, 7 lbs has not shown any reaction as of yet but I still do not use topicals any more and he too takes his flea and tick medication orally.
While I do not enjoy hearing about other animals suffering, I am glad to find out that I am
not just over reacting and that this is being looked into.
Thank you for your time
Jacklyn 3/17/10
Vallejo, CA
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I had a cat named Wedia for 12 years when I put flea medicine on her back. She got very sick and died in a week. The medicine made her thrown up and stop eating. I took her to the vet and he said she had kidney failure. I also put it on my Dog and she got neurological problems and had stokes and then she died. I think this should be taking off the shelf. My Daughter gave it to her pit bull and he got very sick but survived. I loved my pets so much I still cry about them. Why don't they test the med more before they give it to the public? I am a senior and they were my companions.
Deborah 3/17/10
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If we only knew.....we came across your website after the fact.....
We ordered BioSpot for our cat Zoey last week. We received our order on Monday March 15th and applied the medicine on her that evening. At the time of the application, Zoey was healthy and had no signs of illness. The next day, our children came home from school and found Zoey fighting for her life. She was struggling to breath. I quickly came home to her aide but she died immediately after. I rushed her to the vet but it was too late. We believe the BioSpot had something to do with her death. We have another cat but at the same time we applied the BioSpot to Zoey, we used the one remaining BioSpot we had from a previous order on our other cat Sophie. Sophie so far is doing well. We did have her checked by a vet.
We contacted the BioSpot company and they immediately referred us to the poison control center of the ASPCA. The ASPCA is encouraging us to have an autopsy to determine the cause of death. I have no doubt in my mind that BioSpot had some correlation to our beloved Zoey's death.
Anonymous 3/17/10
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PUBLIC ANNOUNCEMENT
The U.S. Environmental Protection Agency announced today that is pursuing a series of actions to increase the safety of spot-on pesticide products for flea and tick control for cats and dogs. Immediately, the EPA will begin reviewing labels and determining which ones need stronger and clearer labeling statements. The EPA will also develop more stringent testing and evaluation requirements for both existing and new products. The EPA expects these steps will help prevent adverse reactions from pet spot-on products.
For more information on the EPA's evaluation of spot-on products and its risk mitigation proposal to help prevent future incidents, please go to:
The EPA wants to hear your comments on its spot-on evaluation and proposal to reduce adverse incidents. Comments must be submitted by 5/17/10.
To submit a comment , please go to:
To read comments that have been submitted, along with other documents that have been placed in the Docket Folder, please go to:
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The EPA has a new website concerning its evaluation of spot-on products, and its risk mitigation proposal:
There is a lot of good information there, including the EPA's review of adverse incidents:
and these data evaluations of individuals products:
and the EPA's Pet Spot-on Risk Mitigation Plan:
Health Canada's Pest Management Regulatory Agency collaborated with the EPA and provided their own evaluation of spot-on products:
There are several aspects of EPA's risk mitigation proposal that are positive (including
adding more weight categories, adding a more complete list of potential side effects
to product labels, requiring companion animal safety studies to include breeds of dogs
that are more susceptible to pesticides, creating pre-market clinical trials and post-market surveillance, and granting conditional registrations for new products), but the EPA has a
long history of being slow to protect pets from dangerous pet pesticide products. Many
of the problems that were identified in its evaluation have existed for over a decade, and have been attributed to being understaffed and underfunded.
Here is an EPA memorandum concerning an evaluation of pet pesticide products and adverse incidents from 1996:
I am glad EPA's evaluation acknowledged that there were major incidents (including seizures) and deaths reported for all of the products. The manufacturers of vet-prescribed spot-on products often deny that their products cause severe reactions, which could lead
to the underreporting of adverse incidents (a problem identified in Health Canada's evaluation summary). Some vet-prescribed spot-on products may cause fewer adverse incidents than other products, but they are still capable of causing adverse incidents
which could be severe.
However, I strongly disagree with the main conclusion of the EPA's evaluation, which
found that "the products could be used safely but that some additional restrictions are
needed." Due to genetic variation, some animals (and people) metabolize these
pesticides much more efficiently than others, which means that some animals (and
people) will always be at a higher risk from these products, even when they are used
as directed. As long as these pesticides target the nervous system of animals
and humans, they will never be safe.
The EPA's new website also includes the following:
"EPA is dedicated to the protection of children risks associated from exposures to pesticides, particularly those used residentially. EPA assesses all pet pesticide treatments, including spot-on products, using a screening level approach. Our review of these products includes a dermal assessment for adults and dermal and oral exposure assessment for children based upon conservative assumptions of pet contact and pesticide transfer to the persons exposed. Inhalation assessment to pet pesticide treatments is considered on a case-by-case basis. EPA scientists estimate the amount of applied pesticide that can transfer from the animal to the child's skin from hugging or otherwise contacting a treated animal. Based on these estimates, the EPA ensures that children are protected from exposure to pesticide treated pets."
EPA residential risk assessments are not based on "conservative assumptions."
In May 2006, a group of EPA scientists and risk managers sent a letter to the EPA Administrator, expressing 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 adhered to principles of scientific integrity and sound science in the pesticide tolerance reassessment it was undertaking:
The letter said, "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 use of these neurotoxicants. This approach -- compliance with the FQPA and our principles of scientific intregrity -- 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."
In September 2006, the Consumer Specialty Products Association (a trade group that represents pesticide product manufacturers) submitted comments to the EPA in regards to the reregistration of permethrin (the main active ingredient/pesticide in many spot-on products) :
The Consumer Specialty Products Association expressed concern about the EPA's "very conservative, highly conservative, and overly conservative assumptions" that were designed to protect children from exposure to pesticides in worst-case scenarios.
As the result of pressure from the pesticide industry, EPA's worst-case, child-protective assumptions (including those concerning the dermal absorption rate of pesticides, the amount of transferable pesticide residue on pets, and the child safety factor required by
the Food Quality Protection Act of 1996) were all systematically replaced with assumptions that had no basis in reality and greatly underestimated the risk to children.
Last April, the NRDC issued a report concerning the risk that flea and tick collars pose
to children:
The NRDC found that residue levels produced by some flea collars are so high
that they pose a risk of cancer and damage to the neurological system of children
up to 1,000 times higher than the EPA's acceptable levels.
Despite the fact that the Food Quality Protection Act of 1996 required the EPA to consider the cumulative effects of pesticides that have a common mechanism of toxicity, the EPA had refused for years to acknowledge that pyrethroids (the class of pesticide found in many household pesticides, including several spot-on pet products) share a common mechanism of toxicity.
However, last June, the EPA FIFRA Scientific Advisory Panel met to consider an EPA proposal that would consider pyrethroids as sharing a common mechanism of toxicity:
If the EPA believes that pyrethroids share a common mechanism of toxicity, all household products that contain pyrethroids will now require a cumulative risk assessment. In other words, the cumulative risk of these products, including pet pesticide products, has not been considered by current risk assessments.
Last October, the EPA FIFRA Scientific Advisory Panel met to consider revisions to EPA's Standard Operating Procedures for Residential Pesticide Exposure Assessment. Here are the meeting minutes:
The EPA's Scientific Advisory Panel expressed concern that EPA's methodology did not adequately protect pregnant women, fetuses, and children. Furthermore, it was critical
of EPA's definition of "toddlers" as children aged 3-6.
The Panel stated, "using the toddler label for ages 3-6 is simply misleading and confusing.
In addition, exposure factor data collected from 3-6 year olds might lead to underestimation of exposures to 2-3 year olds since hand-to-mouth and object-to-mouth behavior generally decline with age. Children with developmental delays, such as those with intellectual disabilities and/or autism, may still exhibit mouthing behavior at age 6. Finally, at least one Panelist is concerned that the Agency's questionable 'toddler' age selection is an indication that actual infant and toddler exposures have not been adequately examined."
Despite the fact that pyrethroid-based spot-on products have been on the market since 1990, the EPA did not begin to include them in residential risk assessments until 2006. That omission was due to an oversight.
When risk assessments were finally done on pyrethroid-based spot-on products, the EPA found that they posed significant risks to toddlers, but the EPA "refined" its assessments using faulty assumptions and data from unpublished studies, submitted by pesticide product manufacturers seeking regulatory approval of their products, to make these products appear to be safe.
Recently, the EPA sent letters to the manufacturers of pyrethroid-based pesticide products (including Bayer's K9 Advantix, Summit VetPharm's Vectra 3D, Farnam's Bio Spot, Adams spot-on products for dogs, Zodiac spot-on products for dogs, and Hartz spot-on products for dogs), expressing concern that studies used to assess the potential for neurodevelopmental damage in children from exposure to pyrethroids were inadequate:
Here is an EPA memorandum concerning those DNT studies:
Excerpts:
"It has been determined that, for pyrethroid pesticides, DNTs do not provide sensitive endpoints for risk assessment or provide sufficient information related to the susceptility of infants and children."
"However, scientific evidence does indicate a continued concern for possible differential sensitivity with direct dosing in juveniles compared with adults. Thus, there is a need for additional information to inform these concerns."
As a result of the EPA's concerns, the manufacturers of many pyrethroid-based products recently informed the EPA of their intention to voluntarily cancel hundreds household pesticide products, including many pet pesticide products.
The EPA's evaluation of spot-on products was hindered by the quality of the incident
data it received from pesticide product manufacturers, a problem that has existed for over
a decade. Instead of relying on product manufacturers to provide complete and accurate incident data, the EPA should require that all adverse incidents be reported directly to the EPA, or an entity that has no financial arrangement with product manufacturers.
The EPA should create an online portal to allow the public to report adverse incidents
directly to the EPA. The NPIC, which is partly funded by the EPA, already has a reporting portal on its website, but it is only for the veterinary community. With a simple modification, the public could begin using it immediately:
The EPA should not rely on pesticide product manufacturers to provide acute toxicity tests and companion animal safety studies. Those studies are in desperate need of an extensive overhaul, and should only be performed by entities that have no financial arrangement with the product manufacturers.
The EPA should also take into consideration the toxicity of product formulations, not just individual active ingredients. Pet pesticide products often contain more than
one active ingredient and inert (other) ingredients which may not be very toxic by themselves, but can significantly increase the toxicity of the product by increasing dermal absorption or decreasing the ability to metabolize pesticides.
During EPA's webcast yesterday, in response to a listener's question, it was shocking
to hear Kit Farwell (one of EPA's veterinarians) say that he has never considered the possibility of a dog being exposed to pesticide by scratching a site where a spot-on
product was recently applied and then licking its foot. That would appear to be a major
route of exposure, and one that has not been considered by companion animal safety studies. In addition, pets can be poisoned by licking the product from application sites on themselves or other treated pets.
The EPA should require that oral safety studies be included in companion animal safety studies for spot-on products. The FDA already requires oral safety studies for topical flea and tick products that it regulates.
It was disturbing to read several articles this morning which proclaimed that EPA found
these products to be safe, but plans to improve labeling. What the EPA actually found
was that the great majority of adverse incidents occurred in dogs weighing 10-20 pounds. Small breeds of dogs, particularly the Chihuahua, Shih Tzu, Miniature Poodle, Pomeranian, Dachshund, and Bichon Frise, were commonly involved
in adverse incidents.
The EPA also found that some products had fewer and wider dose ranges,
resulting in larger doses per pound for dogs at the bottom of each dose range, particularly for dogs receiving product labeled for the smallest dogs.
The EPA stated that another factor which may contribute to the large number of adverse
incidents in small breeds may be that smaller dogs have thinner skin and a greater surface area in proportion to their body weight than larger dogs, resulting in greater absorption of product in smaller dogs than larger dogs. What the EPA failed to mention is that infants and toddlers have thinner skin and greater surface area in proportion to their body weight than adults, increasing their risk of exposure.
If current labeling is inadequate, allowing some dogs (especially those weighing 10 pounds or less) to receive significantly larger doses per pound than other dogs within the same weight range of a product, then how could those products be considered safe for dogs, or
for young children who are exposed to pesticide-treated pets?
It remains to be seen if the EPA's latest evaluation of pet pesticide products and its risk mitigation plan will be effective in reducing adverse incidents and making these products safer for children, but based on previous actions, the public has a right to be skeptical.
The EPA wants to hear your comments on its spot-on evaluation and proposal to reduce adverse incidents. Comments must be submitted by 5/17/10.
To submit a comment , please go to:
To read comments that have been submitted, along with other documents that have been placed in the Docket Folder, please go to:
James TerBush
Website Administrator
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Dear BioSpot & Petowners,
Our 9-1/2 year old chocolate lab has started to have seizures. He is almost 10 years old
and has never had a seizure prior to his first one that started in December 2009. He had
two seizures within weeks apart in December 2009, then he went on to have another one in January 2010 and two more in February 2010. We have been trying to figure this out and eliminating all possibilities of what could be causing this to happen, including switching him to over to an "all natural" dog food containing "no wheat products". This was a good thing as not only were we creating a diet that was much better for him, but also eliminating what we "thought" to be part of the problem.
At first, we did not even think about the possibility that the fles/tick medication, K9 Adantix, could be the culprit of his seizures. Many people, like us, tend to believe all the ads of how they say your pet should not go untreated and this medication will not harm them. After careful review, we did notice a trend that he was having his seizures within week(s) of applying the K9 Advantix flea/tick medication.
After extensive research into the K9 Advantix, we found some very interesting information. K9 Advantix compared to Frontline for dogs is that Frontline only "repels" fleas/ticks where the K9 Advantix "kills" them. K9 Advantix also contains the pesticide Permethrin, which is a high dose pesticide that has been known to poison dogs. K9 Advantix contains 44% of this!!!! When you think about this and where you administer this medication in your pet, which is generally in the nape of the neck area, and then to sit back and think about it that anything you administer in the skin (same for humans) absorbs directly through the central nervous system, which in turn could lead to a variety of health related issues. So, it is highly possible this is what causes this to happen in some pets.
Our dog has also experienced other health related issues over the years such as bad skin allergies and other allergies. He is now on Phenobarbitol medication to control his seizures along with liver supplements to help maintain his liver functions while on the seizure medication. However, that does not justify or make the situation go away when the real problem stems from the K9 Advantix medication. It is the only other possibility that we have not eliminated and we are firmly believing that is the cause of his seizures.
Then there was an article in one of our local newspapers by Dr. Michael Fox, Animal Expert, regarding the use of flea/tick medication and seizure/health related issues resulting from it. This is where we found you to report our experience to.
That is why we have chosen to share our story in hopes that we can help others BEWARE of this product and others that cause the same adverse reactions. Reading your website has given us even more determination that our dogs seizures really ARE a result of the K9 Advantix flea/tick medication. We are no longer using this product and we would love to find a way to report this and get this product off the market and help save other pets who are at risk!! NO MORE CHEMICALS!! There are more "natural" ways of treating your pets from these outside critters.
We want to thank you for sharing everyones stories and we hope that you will also share ours. Any information and feedback would be greatly appreciated! Thank you kindly for your time!
Sincerely,
Lisa & David 3/19/10
Fonda, NY
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Hello..
My beautiful Dalmatian was a victim of a reaction to CapStar...I had a healthy, beautiful, active dog until my husband and I gave it CapStar...My dog reacted right away to the drug...
We took her the to ER and were told that they see cases like this in cats but not dogs. They called poison control for us and shortly after that sent us home with the dog. We were told that she would be fine in the morning...That was not true at all... My dog only went downhill after that.
She could no long walk straight. She staggered, her head would bob up and down, and her back legs would give out. I called the makers of CapStar and they were not very kind to me on the phone. I told them what happened and they found it hard to believe. I find it hard to believe that they don't know the reactions to this this. I felt like as if they were covering up...
We spent much money on medication to help our Doug...I even video taped the dog to show others how she reacted. My doughter wrote our local news station to have them come out to do a story on the dog.,... We never heard back from anyone.... A few months later our dog passed away... I will never give my dog another flea medication ever again.... They are much too dangerous and it killed my healthy, active Dalmatian....
Jackie 3/22/10
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If you happen to live in the Phoenix metropolitan area and have a pet that was harmed by a Sergeants or Sentry spot-on product, please contact:
Nicole Longhini
INVESTIGATIVE PRODUCER
ABC15 KNXV-TV
602.685.6311
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As a person who has worked in the animal industry for over 20 years, I have used most flea and tick products. I too have had a reaction with the Bio-spot cat product and thankfully knew ahead of time what to look for as signs of a reaction. Farhnam reimbursed my vet expenses and bought back all remaining product that was on my shelf for resale. I have used Frontline on both the dogs and the cats without any reaction. I also have not had a reaction to the Advantix. Due to limited income was reviewing using the TriForce from Tradewinds and now have decided no way! My question is what are the alternatives for flea and tick control in both dogs and cats? I have used "natural" spays before, and seems to work ok, but not entirely effective. Does anyone have any suggestions? I spend a fortune on flea and tick control as I have 3 dogs and 3 cats. THANK YOU for having this website, it is now stored in my favorites and am forwarding it to all of the rescue organizations I come into contact with.
Suellyn 3/23/10
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My cat is about 5 months old and weighs about 6 or 7 pounds. He was happy and healthy until I put, for the first time, Advantage Multi for Cats on him. He was outside and when we next saw him several hours later he was staggering and lethargic. He may have licked some of it off (he's got long, thick fur). We took him to the vet and he gave him some fluids but he's still very sick.
I'm very worried about this reaction he's having. We've used Advantage products on our dog and cats previously with no adverse reactions.
Don't know what else to do. Hope he's better tomorrow.
Just wanted you to know that Biospot is not the only potentially dangerous topical solution.
Steve 3/24/10
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Hello James,
There was an article published in Newsday here in New York stating that dogs have died when exposed to this flea product. I searched on the internet to find information on this issue and found your website.
When I read the symptoms of one of the dogs, the realization that this is what our own dog died of four years ago hit me, hard. He was a healthy 7 year old mixed breed brindle dog who was in very good health. After applying the Bio Spot Spot On treatment one morning, he began having seizures about 2pm and was dead 9pm that evening. We thought he had been poisoned or perhaps it was the new fertilizer on the lawn, did he eat the grapes on the counter, we just never knew what killed him, nor did our vet. I did not have an autopsy performed.
What scares me is that I just bought 3 double packs of Bio Spot for the dogs, (my two dogs, my mother's two dogs and my sister's two dogs), and I would have applied it starting next month if my husband hadn't read that article in the newspaper. Now I have used it on our girl dog before with no adverse reaction and it is so much cheaper than Frontline Plus that I thought nothing of purchasing it especially since money has been tight this year. But this would be the first time that I would be using it on the other dogs and what if they couldn't tolerate it? It's just not worth the money to risk my dog's lives.
I can't thank you enough for this information and for potentially saving my new dogs lives.
Best regards,
Susan 3/25/10
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I recently purchased Bio Spot Flea and Tick Medicine for my dogs from Petmeds.com for
my 2 Lhasa Apso's. I put the product on them both on Tuesday night and yesterday my dog Teddy was whining all day and started shaking, vomiting and was lethargic and could not get comfortable, he was also chewing his tail. I could not get an appointment with my vet so I had to take him to an animal hospital. The doctors took x-rays and drew blood but did not find anything except he was dehydrated from vomiting. He was given nausea medicine, IV and pain meds. I took him home and he continued to whine all night but finally started to calm down about midnight and fall asleep. This morning when we woke up my other dog Manny starting exhibiting the same symptoms. Since this was the only new product I had introduced to my dogs, my doctor diagnosed them both with an allergic reaction, she then proceeded
to tell me that she had treated several other dogs with allergic reactions to this product. I decided to start doing research on this product and other products and was surprised and appalled to learn that so many dogs die each year from these types of products and also shocked that they are not regulated. My dogs are my kids and are so important to me, I do not know what I would do without them. What can I do to help to get these deadly products off the shelves? I live in DC so I would love to help. Thank your creating this site, I hope more owners do not have to go through what I experienced or experience something even worse.
Tara 3/26/10
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I too have lost a dog to BioSpot!
We had a wonderful Foxhound, truly our "third child".
I was noticing a reaction to Frontline and asked my vet about alternatives.
I got nothing! I saw Biospot and thought I'd try it and hope for no
reaction from Hunter.
The reverse happened. He became very ill and was at the vet's 3 times in
one month. Not realizing what caused the issue, I applied it again the next
month. Immediately Hunter was very sick. He was unable to move, literally.
He could barely lift his head only. We rushed him to the vet an hour later
at 7am. He endured many tests for 48 hours and passed away.
At the time, I had no idea so many others were experiencing problems
with flea and tick repellent for their dogs. I feel horrible for how Hunter
spent his last two months, especially the fact that it was from something
I applied to him! We thought we were helping to keep him healthy! We
had him on organic food and he walked 4 miles/day. Hunter should have
been in excellent health! During all the tests for those last two months,
they found nothing wrong with him!
I have no proof that was the problem, but the vet consulted with Virginia
Tech. they could find nothing wrong with him. They stated he was having a
severe allergic reaction to something. This is such a painful memory for
me.
I realize my story is a bit old, we lost Hunter May of 2007. But I am feeling
a little less alone knowing others are out there with the same situations.
Susan 3/26/10
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I recently purchased First Shield Trio from Banfield, since applying it to my dogs two of
the three have tried scratching near the spot it was applied at and they shake their bodies
like they are trying to get rid of something on their bodies. My Golden Retriever has developed diarrhea. Have you heard of side effects like this from use on other animals?
I will never use this product again!!
Jayne 3/27/10
First Shield Trio is sold exclusively by Banfield, but it's actually made by Summit VetPharm, and is identical to their Vectra 3D. One of the main active ingredients in Vectra 3D/First Shield Trio is permethrin - a pesticide found in K9 Advantix and many over-the-counter flea and tick products such as Bio Spot, Adams, and Zodiac brand products.
Last week, the EPA announced the results of its year-long investigation of spot-on products (which it began after noticing a sharp increase in adverse incidents from these products).
Here is information concerning the EPA's evaluation of spot-on products:
Here is the EPA's evaluation of adverse incidents that were associated with Vectra 3D:
James TerBush
Website Administrator
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I have been hearing a lot of stuff about the flea treatments lately, my concern is does this
also include Frontline? I ask because my Great Dane has something wrong with her, that
our vet has not been able to diagnose. After reading around on the net , I have seen some side affects that include shaking. Our Dane has been treated with Frontline since she was
8 months old. Last year she started the shaking, loosing weight, and sitting weird / sometimes falling over. Its really hard to explain. She can only eat and drink now while laying down. We have ruled out wobblers, hip dysplasia, Cushing's, heart failure, and a few others (forget names). We are going in for x-rays soon to have her double checked for spinal issues, but after reading about the flea treatment problems, it's making me wonder if I am looking in all the wrong places, so I have stopped all flea treatments.
If there is any info about issues with Frontline I would really like to read more about it.
Aimee 3/30/10
Columbus, Ohio
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(Below is email that I sent to Kimberly Nesci at the EPA on 3/31/10)
Dear Kimberly,
I have read the EPA's review of pet spot-on incidents, and would like to ask you a few questions. Here is the EPA's review of the incidents:
Excerpt from p. 19:
"Recommendations for Continuing Analysis...For weight analysis, there should be more separation of pet weight ranges and assessment as to the percentage of incidents in the upper and lower half of each weight range."
Excerpt from p. 23:
"Thoughts for the future: Next time the team would like to do the following: 6) an analysis of
the dose to which pets were exposed, 8) look at rare but serious toxicities (we discounted
the rare effects)."
Could you please let me know why the EPA's evaluation of pet spot-on incidents did not assess the percentage of incidents in the upper and lower half of each product's weight range, and did not attempt to quantify the dose per pound to which pets were exposed? Since the EPA determined that some 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, and found that the majority of incidents involved small breed dogs and dogs weighing approximately 10-20 pounds, it would seem that knowing the percentage of incidents in the upper and lower half of each product's weight range and the dose per pound to which pets were exposed would have been critical in evaluating the pet spot-on incidents. How can label changes regarding weight range be implemented if that information is unknown?
Also, could you please explain what is meant by "we discounted the rare effects"? Which adverse effects were discounted, and what was the rationale for doing so? Thank you.
Best regards,
James TerBush
Website Administrator
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I bought bio spot because the guy at pets mart said it would work just
as good as frontline. Well I bought it I came home put it on my little
dog and within hours noticed it burned his skin and started to spread I
felt so bad my dog was in pain crying didn't want to be touched but I
have a doctor appointment tomorrow so I'm sure he will be ok but now I
know never to use an over the counter flea control product and rather
spend the extra money in taking my animals to the vet thank you for this
website I wish I would have known about it before I bought the product
but now I'm warning everyone I know thank you for this website....
Erika 3/31/10
Copyright © 2002-2010 BioSpotVictims.org All rights reserved.
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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