Message Board
Bio Spot Side Effects
January 2010
PUBLIC NOTICE

On December 22, 2009, the EPA announced that it will begin accepting public comments on its proposal to require pesticide product manufacturers, including the makers of flea
and tick control products, to disclose inert ingredients on their labels.  The manufacturers
of pesticide products have long fought to keep such information off of product labels by claiming that it is "confidential business information" (trade secrets).

Currently, pesticide makers must label the "active" ingredients in a pesticide product,
but they are not required to identify the so called inert (or other) ingredients, which may
be just as toxic (or more toxic) than the active ingredients.  Inert ingredients are often added to increase the toxicity of the product's active ingredients.  Inert ingredients can be added to enhance dermal penetration and inhibit metabolism.  Unfortunately, most of the EPA's risk assessments, which are required to register a pesticide product, only take into consideration the toxicity of the active ingredient -- not the full pesticide formulation.

For more information on inert ingredients and their health implications, go to:

http://www.thefreelibrary.com/Unidentified+inert+ingredients+in+pesticides:+implications+
for+human...-a0160559034

For more information on the EPA's proposal, go to:

EPA Press Release

http://www.ombwatch.org/node/10668

http://www.epa.gov/opprd001/inerts/

For detailed information on the EPA's proposal, including possible options, go to:

http://edocket.access.gpo.gov/2009/pdf/E9-30408.pdf

The EPA’s proposal outlines general options for inert disclosure on pesticide labels, including mandating disclosure only of potentially hazardous ingredients; mandating disclosure of most or all inert ingredient identities, regardless of hazard; and non-
regulatory voluntary disclosure initiatives by pesticide registrants.  The proposal solicits ideas for both regulatory and non-regulatory approaches and sets forth a series of questions for comment.  EPA believes participation and comment by the public
is important for developing workable and effective solutions.

Public comments must be received by the EPA on or before February 22, 2010.

To submit a comment to the EPA on the above proposal, go to:

http://www.regulations.gov/search/Regs/home.html#submitComment

Comments submitted to the EPA are available for public viewing here:

http://www.regulations.gov/search/Regs/home.html#docketDetail?R=EPA-HQ-OPP-
2009-0635

This issue affects your ability to independently assess the health implications of pesticide products that you and your family may be exposed to.  Please let the EPA
know that full disclosure of inert ingredients is important to you! 

James TerBush


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(Below is a message that was posted on HartzVictims.org on 1/01/10)


Hartz can and WILL kill!!!

Never!! Please, never ever use this product!

We have two beautiful healthy young dogs (4-5 yrs), with a pristine health record (until hartz of course). They get premium food - Timberwolf Organics, Acana, Origen, Blue (I mention this because poor diet is often associated with illness in your pawsy companions).

We had new neighbors with dogs move in a few weeks ago and my little one had started itching a bit. I was going to order frontline from petmeds and instead picked this up in a split second decision while walking out from Wallys. My logic being, “hey if it doesn’t work, I can still order the Frontline”. Plus it was priced at only $5.99

On Saturday evening, I showered the girls and applied this on my itchy one. The next day my dog started showing signs of minor epileptic shocks - yelping in her sleep…yes I do know about dog dreaming, but these dreams, if they were that, were, with shock, pain and disorientation. Since it was Sunday, our regular vet was unavailable. We had no idea how serious this was about to become! That night, convinced that she was having a series of bad dreams we made sure she slept close to us on the bed. The episodes continued that whole night, a couple of hours apart.

Next morning I noticed some swelling on her snout and one of her eyes. There was also a red spot on her belly. By that time we had read other peoples reviews on this product and were shocked that this poison is still put out for unsuspecting consumers!! Alarmed we called the local emergency care and described her symptoms. They urge us to rush her there. By the time we reached the hospital, my baby had gone into an anaphylactic shock. She had petechiae all over her abdomen and she was swollen all over!

She was hospitalized after she was stabilized with steroids, antihistamine and antibiotics. Our woes did not end there though. I can go into more details, but I feel it suffices to tell you all that after about four thousand dollars and a homeopathic detox program, we were finally able to get her close to normal. After about a month and a half today, she still takes some herbs and supplements to support and balance her messed up immune system.

Just ONE tube of the three doses!!

The amount of anguish and death related to this product far outweighs the justification of dogs who might be ‘flea free’. In the course of that week we must have met at least half a dozen vets who just shook their heads when I mentioned the Hartz product!! It has killed hundreds of cats apparently and is more fatal to their littler bodies (my dogs are about 65lbs each).

Please do not, do not buy this poison!!

PS: Friends on the Hartzvictims forum, please also post your reviews on potential buyer sites, like Amazon, which is where I originally posted this review.

Thanks Josh for having this site. I feel sad for, and my compassion goes out to every person and their pets on this forum.

Peace


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Maggie May 5-1-2006 to 12-06-2009. This is a horrific story that I will try to be
as brief as possible in telling. Maggie was our 3 year old black lab. We also
had Max a 14 yr. old border collie mix who was diabetic and had Cushings
Disease and Beau, a 4 month old yellow lab we had recently acquired to keep
Maggie company when Max passed.

Because of the expense of 3 dogs and Max's meds I made the fatefull decision
to switch Maggie from Frontline to BioSpot, which Max had used for years.
All of our dogs were house pets and much loved members of our family, loyal
companions and best friends. Maggies first dose was November 1st. By the
middle of the month she developed skin problems which we did not connect
with the flea meds. I took her to the vet for antibiotics and allergy meds.

On Dec. 1st she received her second dose of BioSpot. By the evening of Dec.
2nd we knew she was not feeling well and called the vet about 11:00PM. The
symptoms were so vague at first, some salivating, aggitation, unable to lay
down that the vet said to watch her and call back in morning.

Dec. 3rd she was still salivating and very aggitated but ate ravenously all
her food and the other dogs which was not like our delicate, gentle Maggie.
She then started with facial tremors and drawing her left front arm up. They
were accompanied by drooling and foaming. My husband took her to the vet
where she displayed the same symptoms in front of the vet. Without examining
her in any way they said they had recently seen a chocolate lab exhibiting
the same symptoms and it was due to injesting something moldy. They printed
out sheet describing this, charged my husband 110.00 and sent him home
saying it would pass in about 48 hours. That night Maggies tremors and
salivating returned along with foaming. She did not even look like herself.

Dec. 4th I took Maggie back to vet for IV treatment and blood work, which
turned out normal. She seemed better and ran a little with Beau. That night
she had full blown epileptic seizures. They were frightening to her and to
us, it was horrible.

The morning of Dec. 5th she looked like a crazed animal, tail between her
legs, foaming and salivating. She would jump back away from any physical
touch. I took her to vet for treatment. That was the last time we saw our
beloved Maggie.

Dec. 6th the vet called in morning said she was no worse, no better. He
called an hour or so later and said she was laying on her side with her lips
curled up and died. They tried CPR and oxygen to no avail. They took her
that afternoon to the state lab for an autopsy. Results were non-specific.
They kept samples of brain, stomach, kidney and liver. We have just paid to
have further testing done to rule in or out toxins. We owe Maggie that.
We are not saying at this time BioSpot was the cause but the timing was
there. No animal or family should have to ever go through an ordeal such as
this.

The blogs we have read and the many people we have talked to have
arroused our suspicions. Our local animal control officer said he had been
to conferences where the issue of toxicity in flea meds was discussed at
length. He was not surprised at our story.

We had Maggie cremated so she could come home to be with her family
again.  I feel I have let my best friend and companion down. She trusted me
to look after her. My heart is broken.

I will keep you informed of the test results.

Dale  1/2/10


I just talked to the Illinois Department of Agriculture Bureau of Animal
Disease Laboratory that did further testing on our lab Maggies remains.
They did a complete toxicology workup. Absolutely nothing showed. No
mold poisoning, no food poisoning, nothing. They can send samples they
have left to California for tremorgenic testing, that is all that is left to do.
The vet there said testing for permethrin will show it is present but not in
what amounts. He said permethrin is well tolerated in most dogs but just
like in humans some dogs can have an adverse reaction.  It seems to
me that too many animals are having adverse reactions.

We are undecided at this time about going ahead with further expensive
testing. I am just sick over this whole issue. Needless to say our lab puppy
has no flea drops used on him. I am going to make contact with the persons
you suggested to talk to and we will go from there.

Dale  1/08/10


Hello James,

Last week my vet received brain and other tissue samples from the Illinois
Dept.of Agriculture. They did the autopsy on Maggie and found nothing
conclusive of course. My vet just sent these off to MSU to be tested for
permethrin poisoning. Hopefully this will be the evidence we need.

Fox News was the only station this past week to mention the problem
with spot on flea products. I at least feel we are making some progress.

The ASPCA Poison Control really was not much help in the matter, which
was extremely disappointing. I almost felt they didn't want to find anything
wrong with flea products.

Farnum Industries refused to pay for any testing hoping I think that I would
just give up and go away. WRONG!

I will keep you posted. Thank you for the wonderful job you are doing to
help pets and their owners get some kind of justice for the terrible wrong
being done to them.

Take care,

Dale B.  3/21/10


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(Below is email that I sent to Kimberly Nesci at the EPA on 1/4/10)


Dear Ms. Nesci,

I just wanted to wish you a happy New Year, and encourage OPP to consider making
the public comment period for its risk mitigation proposal concerning spot-on products
60 days because I believe that 30 days would not be sufficient for the public to become aware of the proposal and respond. 

As you are probably aware, over 60% of U.S. households have one or more dog and/or cat, and spot-on products represent the most widely used form of flea and tick control
for pets.  The risk mitigation proposal will have a direct impact on the health of tens of millions of people (especially children) and pets.  To help formulate the most effective
risk mitigation proposal, it's imperative that all stakeholders (registrants, public health advocates, environmental groups, and concerned citizens) be given adequate time to comment on this issue.  Therefore, I believe that a 60 day public comment period for
the risk mitigation proposal is warranted.

Thank you for your consideration.

Best regards,

James TerBush
Website Administrator
www.BioSpotVictims.org


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(Below is email that I sent to Kimberly Nesci at the EPA on 1/5/10)


Dear Ms. Nesci,

I would like to pass onto you this excellent document that I just came across concerning permethrin toxicity in cats:

http://www.cve.edu.au/files/Permethrin-Intoxication-of-Cats-Biblio-SWP.pdf

It was prepared in November 28, 2009, by Stephen Page, Director of Advanced Veterinary Therapeutics at the University of Sydney:

http://www.vetsci.usyd.edu.au/about/staff/spage.shtml

Here are some excerpts from it:

"Contributing factors - To develop strategies to reduce inappropriate use of permethrin spot-on products in cats, the circumstances facilitating this error must be identified.  On the basis of discussions with veterinary practitioners and reports from owners, factors that may have contributed to the erroneous application of permethrin to cats include: the availability of permethrin spot-on products through non-veterinary sources, insufficient package warnings, and similar packaging of dissimilar products.  Regulatory efforts - Label improvements and post marketing surveillance described.  Conclusion - It is hoped the industry, the EPA, the veterinary community, and pet owners can work together to eliminate the suffering and loss of life caused by the misuse of concentrated permethrin spot-on products on cats."  p.19 (Country of Author: USA, 1999)

NOTE: As part of EPA's reregistration eligibility decision for permethrin in May 2009,
all permethrin labels (including spot-ons) must be amended to include additional risk mitigation measures.  However, I have been unable to locate the specific Data Call-in for spot-on products, which would indicate the date these label amendments are required.  
If such a document exists, could you please forward it to me?

"The topical application of a permethrin spot-on or dip product labeled for use in dogs can lead to tremors and seizures in cats.  These products, which generally contain 45% or 65% permethrin in spot-ons and 3% or more permethrin in dips, are applied to cats accidentally or by individuals who ignore the warnings on the label.  In some instances, cats have developed signs of permethrin toxicosis after being in close contact with (sleeping near or grooming) a dog recently treated with a permethrin spot-on product....Other pyrethroids, including phenothrin and etofenprox, can cause a similar syndrome in cats when used at high concentrations."  p.18 (Country of Author: USA, 2006)

NOTE:  At the EPA's insistence, Hartz discontinued its phenothrin-based spot-on for cats
in December 2005.  Hartz was permitted to continue to distribute its phenothrin-based spot-on for dogs, however, to the best of my knowledge, the EPA did not require Hartz to include any warnings on its phenothrin-based spot-ons for dogs concerning its toxicity to cats.  It should also be noted that Hartz current spot-on product for cats (which is registered to Wellmark International and is identical to Wellmark's Adams and Zodiac brand spot-ons
for cats, as well as Farnam's spot-on for cats) contains a high concentration (40%) of etofenprox.

"It is the view of the authors that because of the likelihood of inappropriate use and toxicity in the non-labelled species, over-the-counter products intended for use in either dogs or cats must have a high margin of safety in all species.  We argue that PSOs (permethrin spot-ons) should only be available at points of sale where veterinary advice can be provided and appropriate warnings given.  As interim measures, modified labelling with more explicit warnings may reduce morbidity and mortality."  p.17 (Country of Author: Australia, 2009)

The above excerpt, which consists of only three sentences, is a keen assessment of the problem (which has existed for over ten years) and puts forth the most effective risk mitigation measures.   I urge OPP to consider adopting these reasonable measures
as part of its risk mitigation proposal.

Thank you for the consideration.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


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(Below is email that I received from Stephen Page, Director of Advanced Veterinary Therapeutics at the University of Sydney, Australia on 1/07/10)


Dear James, I am so pleased that you found the bibliography useful.  Since it
was posted there are a number of additions to be made, including articles in the
January and February issues of the Journal of Feline Medicine and Surgery.

Malik, R., M. P. Ward, et al. (2010). "Permethrin spot-on intoxication of cats:
Literature review and survey of veterinary practitioners in Australia." Journal
of Feline Medicine & Surgery 12(1): 5-14.

Sparkes, A. and C. Bessant (2010). "Permethrin and cats don't mix - call for
action." Journal of Feline Medicine & Surgery 12(1): 2-3.

You may also be interested in the permethrin posters at:

http://www.cve.edu.au/resources

I believe some progress is being made with regulatory agencies in a number of
countries to reduce the morbidity and mortality of inadvertent treatment of cats.

Very best wishes, Stephen


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(Below is email that I sent to Stephen Page, with copies sent to Claire Gesalman and Kimberly Nesci at the EPA on 1/07/10)


Dear Mr. Page,

Thank you for taking the time to reply, and for the additional information.  I will forward it
to personnel at the U.S. Environmental Protection Agency, who are in the process of formulating a risk mitigation proposal concerning spot-on products.

I am very glad that you and Richard Malik and others in Australia have taken it upon yourselves to critically analyze this issue (which, as you have indicated, is a worldwide problem) and have put forth several key recommendations to effectively mitigate it -- 
including prohibiting the sale of over-the-counter permethrin-based spot-on products.  
It should be clear to everyone that regulatory agencies have so far failed to adequately address this issue.  I am especially critical of the U.S. EPA, because other regulatory agencies around the world often look to it for guidance in establishing their own
pesticide regulations.

I hope that you will consider expanding your research to include the adverse effects in
cats from etofenprox -- another synthetic pyrethroid which is found in high concentration (40%) in several spot-on products for cats in the U.S.A. (and perhaps in several
other countries).  There have been several reports of toxicity in cats (including deaths)
from spot-ons that contain etofenprox.

It truly is appalling that this problem has been allowed to exist for over ten years, but
what is even more alarming is the serious health risks these products pose to people -- especially infants and toddlers.  That is another aspect of this issue that is often not
recognized by the public or accounted for by regulatory agencies and is worthy of
future research.

Best regards,

James TerBush
Website Administrator
www.BioSpotVictims.org


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(Below is email that I sent to Kimberly Nesci at the EPA on 1/07/10)


Dear Ms. Nesci,

I want to pass on to you two excellent articles which Stephen Page, Director of Advanced Veterinary Therapeutics at the University of Sydney, Australia, referred to in email that he sent to me (please see my response, which I forwarded to you this morning):

http://www.biospotvictims.org/sdarticle2.pdf

Excerpt:

"Clearly current warnings on these products are inadequate and need to be improved.  Further, we support wholeheartedly the call for the licensing authorities to take note of this problem and restrict the sale of PSO (permethrin spot-on) products to veterinary outlets, where appropriate advice can be given.  Indeed we know from surveying veterinary surgeons in the UK that there is widespread support for such a measure here, as well as
in Australia.  Bottom line is we need action now to stop these poisonings and deaths."

http://www.biospotvictims.org/sdarticle.pdf

Excerpt:

"Many owners did not understand that 'toxic to cats' or 'do not use on cats' means that cats may die as a result of applying the product."

"It is clear from the data that many members of the public cannot grasp the concept that a drug [flea and tick product] available OTC can be safe for use on dogs but lethal when applied to cats....The high incidence of toxicity suggests that current warnings do not spell out the potentially lethal consequences of non-compliance.  Finally, there is insufficient warning that secondary intoxication to cats can result from exposure to dogs treated with permethrin, through contact, mutual grooming or via grooming aids."

"Permethrin spot-on products cannot be expected to be used safely without expert consultation and advice.  But even with the best of advice, these products still pose a substantial risk to feline patients because owners are human and thus prone to error.  There is a substantial body of literature describing the ineffectiveness of warning labels.  The latest generation of topical and systemic flea treatments (fipronil, imidacloprid, selamectin, moxidectin, lufenuron, nitenpyram) have very wide margins of safety in cats and dogs, and lend themselves to integration into a programme for flea control that addresses all stages of the flea life cycle.  Our view, and that of 90% of survey respondents, is that PSO products should be scheduled as a 'prescription animal remedy' (S4) and no longer be available OTC at non-veterinary outlets."

"A similar conclusion was reached by Delhaye after assessing the (lack of) effect of label changes on PSO intoxication of cats in France.  Similar experience in the USA and UK (including N Sutton, R Tiffin and C Bessant, personal communication, December 2008) suggests that changes in labelling and increased awareness of this problem are unlikely to reduce the incidence of intoxication.  Despite changes to labelling in these countries, PSO intoxications continue.  Indeed, the number of reported feline exposures to permethrin in the UK has increased with publicity and veterinary awareness, suggesting that cases were previously under-reported."

Please forward this information to members of your Companion Animal Team, and anyone else who is responsible for formulating your risk mitigation proposal concerning spot-on products.  Thank you.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


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pics of my dogs after biospot

i would like to put this on the c.e.o's butt and see how he likes it my dogs had a lot of problems almost killed my lab

bryan 1/07/10

you can use the pics if you want

[Photo1]   [Photo2]


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(Below is email that I sent to the American Veterinary Medical Association  on 1/10/10)


To whom it may concern,

As you may know, the EPA issued an Advisory last April concerning spot-on flea and
tick products, and launched an investigation into the 44,000 adverse incidents that were reported in 2008.  The results of the investigation were supposed to have been released last October, but it has been delayed and is now expected to be released next month. 
The EPA will also put forth a risk mitigation proposal and seek public comment.  I am writing to urge the AVMA to submit comments to the EPA when the public comment
period becomes available.

To the best of my knowledge, the last time the AVMA issued a position statement concerning permethrin toxicosis in cats from spot-on products was June, 2000:

http://www.avma.org/onlnews/javma/jun00/s060100w.asp

The AVMA's ten-year long silence on this issue is truly unacceptable.  Please urge the
EPA to consider the following risk mitigation measures (which were recommended in
an article published this month in the Journal of Feline Medicine and Surgery):

-Require over-the-counter flea control products to have a high margin of safety in all species.

-Restrict the availability of pyrethroid-based spot-on products to points of sale where veterinary advice can be provided and appropriate warnings given.

-As interim measures, modified labelling with more explicit warnings (e.g. WARNING -
This product may cause serious harm or death if applied to or ingested by cats) may reduce morbidity and mortality."

If the AVMA were to take the above action, I believe it would significantly help to prevent
the needless suffering of tens of thousands of pets (and pet owners) each year.

Thank you for your consideration.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


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(Below is email that I sent to Kimberly Nesci at the EPA on 1/13/10)


Dear Ms. Nesci,

I just became aware of a newly registered spot-on flea and tick product for dogs, EPA
Reg. No. 2724-796, which was registered to Wellmark International on March 10, 2009.  
I am writing to request clarification of the approved label claims that concern secondary exposure to cats.

Here is an EPA memorandum concerning the above product, dated February 5, 2009:

http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/128965/128965-105402-067501-2009-02-05a.pdf

On page 2, it states:

"It is also noted that the label claims: 'Can be used in households with dogs and cats' and 'Based on testing, accidental exposure to cats will not cause serious harmful effects' [presumably based on additional studies which have been submitted to the Agency]
have not yet been evaluated and accepted."

On page 20, under the heading, Label Review Summary for 2724-TOA, which was reviewed and signed by Clayton Myers on March 10, 2009, the following lable claims
were determined to be acceptable:

"[Can be used in households with dogs and cats] -- acceptable"

"[Based on testing, accidental exposure to cats will not cause serious harmful effects]--Acceptable"

However, according the the following EPA document, which is also dated March 10,
2009, the above mentioned claims were ordered to be removed from the label before
the product is released for shipment:

http://oaspub.epa.gov/pestlabl/ppls.srchreslt?CompNum=2724&ProdNum=796

The above mentioned label claims are clearly safety claims, which are prohibited by FIFRA:

http://www.epa.gov/oppfead1/labeling/lrm/chap-12.htm

Could you please clarify if the above mentioned label claims were approved?  Also,
could you please let me know why the EPA registered this product without requiring warnings on the label concerning the risk of secondary exposure to cats?  Thank you.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


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(Below is email that I received from the American Veterinary Medical Association
on 1/13/10, in response to my email message posted above)


Mr. TerBush,

I am glad to see others are also eagerly anticipating the EPA's release
of its findings regarding this investigation.  The AVMA has been engaged
in this issues for several years, and reported on the EPA's April 2009
announcement of its evaluation proceedings in the May 15, 2009 JAVMA
News article http://www.avma.org/onlnews/javma/may09/090515b.asp.  We
search the Federal Register daily to see if this as well as other issues
of concern to the veterinary profession have been announced so that we
may participate in the requests for public comment. 

Thank you for sharing your information with us.

Sincerely, 

Kristi Henderson, DVM
Assistant Director, Scientific Activities
American Veterinary Medical Association
1931 N. Meacham Road, Suite 100
Schaumburg, IL 60173


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(Below is email that I received from Kevin Sweeney at the EPA on 1/13/10, in response
to email that I sent to Kimberly Nesci, posted above)


Dear Mr. TerBush,

I  am writing in reply to your email to Ms. Kimberly Nesci, Product
Manager 11, in the Office of Pesticide Programs regarding the labeling
for EPA Reg. No. 2724-796 (TOA).  In the Agency's registration notice to
Wellmark International dated March 10, 2009, which I approved,  the
registrant was required to remove the label claims you are concerned
about.  They were not approved.

With regard to recommendations and statements made by science reviewers,
please note that the Agency carefully considers  all science data
evaluation reviews (DERs)  in the context of FIFRA and labeling policy
for each product.  As part of our quality assurance process we review
DERs to ensure that the recommendations made are consistent with sound
science, the Agency's policies, and FIFRA. When preparing any
registration notice accompanying approved labeling we include the
appropriate recommendations from these reviews in order to reduce
pesticide risks to humans, domestic animals and the environment.  The
registration notice for the subject product was (and is)  consistent
with that objective.

Please do not hesitate to contact me should you have further questions
regarding this action.

Sincerely,

Kevin J. Sweeney, Senior Entomologist
U.S. Environmental Protection Agency
Office of Pesticide Programs
Registration Division (7505P)
1200 Pennsylvania Avenue, NW
Washington, D.C. 20460-0001


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(Below is email that I sent to Kevin Sweeney at the EPA, in response to his message posted above)


Dear Mr. Sweeney,

Thank you for your prompt reply.  I am glad to hear that Wellmark's safety claims
concerning cats were not approved for EPA Reg. No. 2724-796.  However, I am deeply troubled by the lack of warnings on that product concerning the risk of secondary exposure to cats.  I consider that omission to be a serious oversight by OPP's product registration process, which may result in the needless suffering and death of thousands of animals each year.  In addition, the lack of ANY warnings on that product (as well as other EPA-registered spot-on products) concerning the risks to children from exposure to recently treated pets, and the lack of ANY warnings concerning the potential for severe adverse reactions in recently treated pets is simply unacceptable.

The EPA should consider adopting a hazard-based labeling system.  Here's an example
of hazard-based information for a spot-on product in the UK:

http://www.noahcompendium.co.uk/bayer_plc/advantix/-40975.html

Excerpts:

"Care should be taken to administer the product correctly as described above, under Method of Administration. In particular, oral uptake due to the licking of the application site by treated or in-contact animals should be avoided."

"In very rare cases dogs may show behaviour changes (agitation, restlessness, whining
or rolling), gastro-intestinal symptoms (vomiting, diarrhoea, hypersalivation, diminished appetite) and neurological signs such as unsteady movement and twitching in dogs
susceptible to the ingredient permethrin. These signs are generally transient and self-resolving."

"Poisoning following inadvertent oral uptake in dogs is unlikely but may occur in very rare cases. In this event, neurological signs such as tremor and lethargy can occur. Treatment should be symptomatic under veterinary medical attention. There is no known specific antidote."

"Treated dogs should not be handled, especially by children, until the application site
is dry. This may be ensured by treating dogs when children are not present, eg in the evening after children have gone to bed. In this case, recently treated dogs should not
be allowed to sleep together with their owner, especially children."

Why can't the U.S. protect its children and pets from unreasonable harm by providing adequate warning information on pesticide labels, like they do in other countries?

I first became aware of the risk to cats from highly concentrated etofenprox-based
spot-on products in July, 2005.  That's when I began receiving horrific reports of seizures and deaths in cats from the use of a new product called Bio Spot One-Step for Cats, EPA
Reg. No. 69332-3-270, which contained 55% etofenprox.  I forwarded those messages
to the EPA, and posted them on my website:

http://www.biospotvictims.org/2005-07.html

http://www.biospotvictims.org/2005-08.html

http://www.biospotvictims.org/2006-05.html

To the best of my knowledge, the EPA took no action to mitigate the problem.  However,
in August 2005, Farnam made the extrordinary decision to discontinue Bio Spot One-Step for Cats -- just five months after Farnam had released it.  Unfortunately, Farnam never
recalled the product, so pets continued to suffer and die while inventories were allowed to be depleted.  It also did not stop Sergeants (who had licensed the product to Farnam) from distributing it under its own brand name (which is still on the market).  Here is the label for it:

http://www.lookatthelabel.com/images/cat_label.html

It's worth noting that the Sergeant's label contains the following statement, "Households
with more than one cat should not allow cats to groom each other until solution has dried."

The above statement was required by EPA due to safety concerns, as indicated in this EPA memorandum (which, by the way, you wrote) in April 2004:

http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/128965/128965-2004-04-21a.pdf

Excerpt:

"A re-application interval of every 21 days is recommended or an increase in product application volume.  However, the animal safety study results for cats show that the proposed label application rate is at the limit of safety for cat exposure to a spot-on
containing etofenprox.  Therefore, EPA recommends a reapplication interval based on animal safety of 30 days. Remove the 21-day reapplication interval from the label."

and in this follow-up memorandum, which was sent to you by Byron T. Backus, Ph.D.,
in June 2004:

http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/128965/128965-2004-06-01a.pdf

Excerpt:

"Labeling also includes a statement that households with more than one cat should not allow cats to groom each other until the solution has dried."

If the EPA does not have any record of Farnam's abrupt discontinuation of its Bio Spot One-Step for Cats, here is a letter that Farnam distributed in August 2005:

http://www.biospotvictims.org/Farnam.jpg

Based on EPA's labeling recommendations for Sergeant's etofenprox-based spot-on product for cats, and ten year's worth of published scientific data concerning the adverse effects of pyrethroid-based spot-on products on cats, I believe that precautionary statements on the label of EPA Reg. No. 2724-796 concerning its toxicity to cats are warranted.  Such statements are required for highly concentrated permethrin-based
spot-on products for dogs, and should be required for other highly concentrated
pyrethroid-based spot-ons -- including those which contain phenothrin and etofenprox
as the active ingredient.

Here is a bibliography concerning pyrethroid poisoning in cats from spot-on products, which was published by Stephen Page, Director of Advanced Veterinary Therapeutics at the University of Sydney, Australia, in November 2009:

http://www.cve.edu.au/files/Permethrin-Intoxication-of-Cats-Biblio-SWP.pdf

Excerpt:

"The topical application of a permethrin spot-on or dip product labeled for use in dogs can lead to tremors and seizures in cats. These products, which generally contain 45% or 65% permethrin in spot-ons and 3% or more permethrin in dips, are applied to cats
accidentally or by individuals who ignore the warnings on the label.  In some instances,
cats have developed signs of permethrin toxicosis after being in close contact with (sleeping near or grooming) a dog recently treated with a permethrin spot-on product.... Other pyrethroids, including phenothrin and etofenprox, can cause a similar syndrome in cats when used at high concentrations."  p.18 (Country of Author: USA, 2006)

Here is contact information for Stephen Page:

http://www.vetsci.usyd.edu.au/about/staff/spage.shtml

Here are two recently published articles, which Stephen Page made me aware of, concerning pyrethroid poisoning in cats:

http://www.biospotvictims.org/sdarticle2.pdf

http://www.biospotvictims.org/sdarticle.pdf

NOTE:  At the EPA's insistence, Hartz discontinued its highly concentrated phenothrin-based spot-on for cats in December 2005.  Under the agreement, Hartz was permitted to continue to distribute its highly concentrated phenothrin-based spot-on for dogs, however, the EPA did not require Hartz to include ANY additional warnings on its phenothrin-based spot-ons for dogs concerning its toxicity to cats.  It should also be noted that Hartz current spot-on product for cats (which is licensed to Hartz by Wellmark International and is identical to Wellmark's Adams and Zodiac brand spot-ons for cats, as well as Farnam's spot-on for cats) contains a high concentration (40%) of etofenprox.  All of these products are currently being investigated by OPP due to safety concerns.

Last year, in an effort to counter criticism of its products, Hartz published "an independent statistical analysis of Hartz safety record," which was conducted by a professor at Washington State University.  Here is a link to it:

http://www.thetruthabouthartz.com/docs/AdverseEventsData.pdf

The study was hardly independent because Hartz Manager of Scientific Affairs, Dr.
Melinda Fernyhough, is a 2006 graduate of Washington State University and was taught
by the professor who was hired by Hartz to conduct the survey.  However, it is still
worth examining the graph on page 8, which shows the topical adverse effect by active ingredient.  Surprisingly, etofenprox, a pyrethroid that is supposedly safe for cats, had a higher number of adverse incidents associated with it than permethrin, a pyrethroid known to be deadly to cats.

That statistic correlates with data from the latest annual report from the NPIC:

http://npic.orst.edu/reports/NPIC08AR.pdf

Excerpt from page 49:

"Table 17.2 shows the active ingredients involved in the majority of the animal deaths.  Methoprene, piperonyl butoxide, pyrethrins, metaldehyde, cyphenothrin, ethofenprox [sic], permethrin, pyriproxyfen, and zinc phosphide were reported to be associated with the
largest number of animal deaths."  While the numbers may appear to be insignificant, keep in mind that the vast majority of adverse incidents are never suspected or reported to anyone.

Here is an EPA memorandum concerning a dislodgeability study that was submitted by Sergeants for its etofenprox-based spot-on for cats.  It was determined by the EPA to be "unacceptable for risk assessment purposes":

http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/128965/128965-2006-09-21a.pdf

Excerpt from page 4:

"Finally, in the dislodgeability study no etofenprox was recovered at all from any gloves used to stroke the cat for 4 hours, 24 hours, or 2 days after treatment.  It is the opinion of HED's ExpoSAC that the absence of removable, detectable residues is unlikely
following pet treatment with etofenprox."

The risk of exposure to toddlers from recently treated pets should be of utmost concern to the EPA.  Companion animal safety studies of spot-on products (including the study for EPA Reg. No. 2724-796, which you approved) often cite "oily fur" as a common
observation.  The oily appearance of the animal's coat is considered a "cosmetic effect"
by the EPA, but this condition can persist for days and represents a major route of pesticide exposure to toddlers (a risk not disclosed on product labels).

Here is an EPA memorandum concerning the Companion Animal Safety Study for Wellmark International's etofenprox-based spot-on for cats:

http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/128965/128965-2005-08-24a.pdf

Excerpts from page 2:

"Etofenprox is structurally similar to pyrethroids which are known to cause sensations
(such as tingling, burning, itching or numbness) at dermal exposure sites."

"TRB concludes that this companion animal safety study (OPPTS) is acceptable in demonstrating an adequate margin of safety (at least 5X) between the exposure associated with the proposed application rate for this formulation (1.0 mL) in kittens between the age of 12 weeks and 6 months weighing less than 5 lbs and that at which significant systemic effects may occur."

Over 44,000 adverse incidents from spot-on products were reported to the EPA in 2008 -- a 53% increase over 2007.  How many incidents will be reported in 2009?  The vast majority of these incidents are associated with pyrethroid-based products.  Instead of
registering EPA Reg. No. 2724-796, which loses its efficacy after only 23 days but will likely be poisoning people and pets for the next decade, EPA should move to prohibit the sale of over-the-counter pyrethroid-based spot-on products, and as Stephen Page and his
colleagues have recommended, replace them with products that have a high margin of safety in all species.

Thank you for your consideration.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


(Below is a follow-up message that I sent to Kevin Sweeney at the EPA on 2/23/10)


Dear Mr. Sweeney,

Attached is email that I sent to you on January 14, regarding the registration of EPA
Reg. No. 2724-796, but to date I have not received a reply.

Specifically, could you please address why the above mentioned product was not
required to have any precautionary statements concerning its potential to cause
significant adverse effects (including death) in cats, as is required on the label of permethrin-based spot-on products for dogs, and which is vaguely implied on the
label of Sergeant's etofenprox-based spot-on for cats, EPA Reg. No. 69332-3-2517
by the following statement, "Households with more than one cat should not allow
cats to groom each other until solution has dried."

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


(Below is email that I received from Kevin Sweeney at the EPA on 2/23/10, in response
to my email, posted above)


Dear Mr. Terbush,

My original reply addresses this issue. The Agency recommended labeling
and data in-line with our science findings. These are outlined in the
Notice of Registration.  At this time we do not believe that the
statement you mention below needs to be added to these products.
However, the Agency is currently revisiting pet product  policy and if
recommendations emerge that institute such a requirement, the affected
registrant will be notified.

Best regards,

Kevin J. Sweeney, Senior Entomologist
U.S. Environmental Protection Agency
Office of Pesticide Programs
Registration Division (7505P)
1200 Pennsylvania Avenue, NW
Washington, D.C. 20460-0001
+1 703 305 5063


(Below is email that I sent to Kevin Sweeney at the EPA on 2/23/10, in response to his email, posted above)


Mr. Sweeney,

Could you please share with me your science findings that support the product's safe
use in households with cats?  I am having a difficult time understanding why the EPA required Sergeants to include a vague precautionary statement ("Households with
more than one cat should not allow cats to groom each other until solution has dried.")
on its etofenprox-based spot-on for cats, EPA Reg. No. 69332-3-2517, which is
packaged in 1.4 mL vials containing 55% etofenprox, but the EPA does not believe
that precautionary statements concerning cats are required for EPA Reg. No. 2724-796, which is packaged in vials up to 9.0 mL for dogs over 60 lbs., and which contains
30% etofenprox.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


(Below is email that I received from Kevin Sweeney at the EPA on 2/23/10, in response
to my email, posted above)


I'm sorry but I cannot share the review with you. You must request such
documents through a Freedom of Information Act request. to EPA.  The
contact information is on the EPA web site.

Kevin J. Sweeney, Senior Entomologist
U.S. Environmental Protection Agency
Office of Pesticide Programs
Registration Division (7505P)
1200 Pennsylvania Avenue, NW
Washington, D.C. 20460-0001
+1 703 305 5063


(Below is email that I sent to Kevin Sweeney at the EPA on 2/23/10, in response to his email, posted above)


Mr. Sweeney,

For an Administration that is quick to promote a new spirit of openness and transparency within the EPA, that's unfortunate.  

My FOIA request for documents regarding EPA Reg. No. 2724-796 is already pending.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


(Below is email that I received from Kevin Sweeney at the EPA on 2/24/10, in response
to my email, posted above)

Dear Mr. TerBush,

The data submitted by the registrant are proprietary. Any data
evaluation reviews conducted by EPA must be reviewed by the team that
handles FOIA requests to insure that no Confidential Business
Information is released as it is protected by law.  I am not authorized
to release this information without the required internal review.

Thank you for your understanding in this matter.

Best regards,

Kevin J. Sweeney, Senior Entomologist
U.S. Environmental Protection Agency
Office of Pesticide Programs
Registration Division (7505P)
1200 Pennsylvania Avenue, NW
Washington, D.C. 20460-0001
+1 703 305 5063


(Below is email that I sent to Kevin Sweeney at the EPA on 2/24/10, in response to his email, posted above)

Dear Mr. Sweeney,

I understand your position and thank you for the explanation.  It's unfortunate that the EPA relies so heavily on unpublished toxicity and safety studies that are funded by registrants and submitted for the sole purpose of gaining approval (registration) for their products.  Many of these studies are marginally acceptable at best, and based on the number of adverse incidents that are reported each year to the EPA, fail to protect people and pets from unreasonable harm.

Based on the proposed label claims for EPA Reg. No. 2724-796, specifically:

"Can be used in households with dogs and cats."
"Based on testing, accidental exposure to cats will not cause serious harmful effects."

It is clear that the registrant intends to market this product as a safer alternative to permethrin-based products.  The fact that the above claims have been disallowed
ON THE LABEL by EPA, either due to unacceptable studies, or the fact that the
above statements are safety claims which are prohibited by FIFRA, will not in my
opinion prevent the registrant from implying in its promotional material that this
product is safer for households with dogs and cats.  For example, they could
simply claim, "Contains NO permethrin" and consumers would rightly assume it
was safe for households with cats.

According to the following EPA memorandum, EPA Reg. No. 2724-796 will be
required to include on its label, "USE ONLY ON DOGS OR PUPPIES.  DO NOT
USE ON OTHER ANIMALS!":

http://www.biospotvictims.org/EPA-2724-796.pdf

However, the label fails to indicate what would happen if used on other animals, or if
other animals come into close physical contact with recently treated dogs.  Given the
fact that each dosage contains up to a maximum of 9.0 mL of formula, and considering
the slow absorption rate of the product, the risk to "other animals" would appear to be significant, including seizures and death (based on the risks to cats from similar
pyrethroid-based spot-on products).

Fortunately, EPA Reg. No. 2724-796 has not been placed on the market yet as the
EPA is waiting for two additional studies (one-year storage stability, and corrosion characteristics studies) to be submitted by June 1, 2010.  Therefore, there is still
time for the EPA to make revisions to the precautionary statements on the label
BEFORE IT GOES INTO PRODUCTION.

Thank you again for your consideration.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


UPDATE:  According to the National Pesticide Information Center's 2010 Annual Report, which covers the period April 1, 2010 - March 31, 2011, etofenprox (ethofenprox) was reported to be associated with more animal deaths than permethrin.

http://npic.orst.edu/reports/NPIC10AR.pdf

On May 6, 2011, the manufacturer of EPA Reg. No. 2724-796 uploaded a promotional video on YouTube, which states, "Bio Spot Defense Flea and Tick Control for Dogs can even be used in households where there are cats," implying that it is safe for cats. 

http://www.youtube.com/watch?v=mnX7JLTyQWg

On December 23, 2011, the EPA sent me the "registration jacket" (which contains all documents that were related to the product's registration) for EPA Reg. No. 2724-796 -- TWENTY-TWO MONTHS AFTER I SUBMITTED A FREEDOM OF INFORMATION ACT REQUEST FOR IT!!!

Here is the registration jacket for EPA Reg. No. 2724-796:

2724-796-vol.1.pdf

2724-796-vol.2.pdf

2724-796-vol.3.pdf

The above documents show that EPA had significant concerns about adverse effects (including deaths) in cats from accidental exposure to EPA Reg. No. 2724-796.

On November 10, 2011, the EPA approved a revised label for EPA Reg. No. 2724-796, which included warnings concerning accidental exposure to cats:

http://www.epa.gov/pesticides/chem_search/ppls/002724-00796-20111110.pdf


         ***************************************************************************************


Hi James,

Thank you so much for your boldness in educating the public about these flea products.
I have said for years that I suspected they are deadly to domestic pets because they
clearly are labeled to the appliers to "wash their hands" immediately after use. That tells
you that the chemicals are very harmful...a true pesticide that kills. Damaging the liver,
kindneys and brain (neurologically). We have been doing dog rescue in Oregon for 35 years and at times have been forced to use Advantage and Frontline infrequently to get control of a serious flea outbreak. But now we treat our yard with Cedar liquid, bathe the dogs in Dawn dish detergent, treat their water with apple cider vinegar, their food with a little garlic and yeast. Those are the only true safe methods of "flea control". You see our most precious spaniel started having seizures from petite escalating to grand mal and a complete personality change. We recently took in a beautiful Cocker who's owner used BioSpot on him and after one dose his neurologically system was completely altered. He starting stumbling, falling and appears to have lost sight in one eye.

It is so sad that hundred of thousands of pets are being poisoned by these products and
they are still on the market.

What do you suggest that we do to make a difference...except to stop purchasing and hit
them in the pocketbooks?

Sincerely,

Loretta Wagler - ARKOregon Animal Services

"Until you have loved and been loved by an animal, your soul remains unopened"


Hi Loretta,

Thank you for taking the time to write.  I totally agree with you.  The labels on these products caution against getting the product on your skin or clothing (as if getting it on your clothing is worse than getting it on your skin), but they provide no warnings concerning the risk of putting it on a pet's skin.

I believe that most of the adverse incidents that are reported concerning spot-on products are caused by highly concentrated pyrethroid-based (e.g. permethrin, phenothrin, cyphenothrin, and etofenprox) products that are sold over-the-counter.  However, even the products that are sold exclusively by veterinarians are capable of causing adverse reactions, which may be just as severe as the reactions caused by the over-the-counter products.  If possible, I believe that it's best to avoid using these products (especially in households with children and/or cats) and use them only as a last resort and until the problem is resolved.

Here is an article from Gina Solomon, Senior Scientist NRDC, concerning toxic flea products, which appeared yesterday in the Huffington Post:

http://www.huffingtonpost.com/gina-solomon/tell-petco-petsmart-to-ta_b_423118.html

Here is a letter that Nicholas Halbach, DVM, submitted to the EPA last October on this issue:

http://www.biospotvictims.org/EPA-HQ-OPP-2009-0516-0038.pdf

As you may know, the EPA issued an Advisory concerning spot-on products last April, and announced that it had launched an investigation into the 44,000 adverse incidents that were reported in 2008.  The results of the investigation are expected to be announced next month, along with a risk mitigation proposal.  The EPA will also announce that it is seeking PUBLIC COMMENT on this issue and its risk mitigation proposal (EPA public comment periods are typically 30 days, but I have urged the EPA to provide a 60 day public comment period for this issue).

The EPA will post the results of its investigation (and its risk mitigation proposal) on its website:

http://www.epa.gov/pesticides/health/flea-tick-control.html

I believe that it's imperative for individuals who are concerned about this issue to submit comments to the EPA when the public comment period is available next month.  If we fail to take advantage of this opportunity, the EPA's risk mitigation plan will likely fail to protect children and pets from toxic flea products for years to come.

It's also extremely important for people to report suspected adverse incidents to the National Pesticide Information Center (they collect the information for the EPA) and the product manufacturers.  Unfortunately, the vast majority of adverse incidents from toxic flea products are not suspected or reported to anyone, making it impossible for the EPA to appreciate the full extent of the problem.

As Gina Solomon at the NRDC has suggested, it's also an excellent idea to contant retailers (such as Petco and Petsmart) and urge them to remove toxic flea products from their stores and replace them with products that have a high margin of safety in all species.

If we all work together on this issue, perhaps it will begin to make a difference.  Let's hope so.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


         ***************************************************************************************


PUBLIC NOTICE

(Below is email that I received from the NRDC's Green Paws on 1/15/10)


Hi James,

GreenPaws.org is pushing a new consumer action campaign which I thought might be of interest to your readers at BioSpotVictims.org. 

Green Paws and the Natural Resources Defense Council are prompting consumers to appeal directly to the Presidents and CEOs of big box retailers like PETCO and PetSmart to remove flea and tick collars containing the harmful chemicals tetrachlorvinphos and propoxur.  This attempt to directly contact retailers is designed to add greater support for our formal petition with the EPA to ban tetrachlorvinphos and propoxur from pet products as well as our lawsuit filed in California against 16 major retailers who carry flea and tick products which are in violation of California's Safe Drinking Water and Toxic Enforcement Act, which prohibits businesses from knowingly exposing consumers without proper warning to any chemical "known to the state to cause cancer or reproductive harm".

Those interested in sending a message directly to these retailers can do so at the following link:  http://bit.ly/grnpaws

We are using the following video to aid in our promotions.  Please feel free to repost it if you would like.

http://www.youtube.com/watch?v=UkKD9AF-6Xs

Here are some more resources if you need them:

NRDC blog posts relating to Green Paws:

http://switchboard.nrdc.org/greenpaws.php

Our updated product guide:

www.greenpaws.org/products.php

I hope you'll find this information useful and if you do decide to help us promote this campaign please send along links to any of your articles.

Thanks!

Katie


Thank you very much for the information, Katie! 

I share Dr. Solomon's frustration with the EPA and retailers who sell dangerous pet pesticides.  Despite the fact that the EPA issued an Advisory last April concerning
spot-on products, most stores and websites continue to sell these products without
providing ANY warnings to consumers.  That is really unacceptable!

I hope the NRDC will consider expanding its Green Paws Consumer Action
Campaign to include ALL highly concentrated pyrethroid-based (e.g. permethrin, phenothrin, cyphenothrin, and etofenprox) spot-on products.  These products, which
are inexpensive and available over-the-counter in pet stores, supermarkets, and
drug stores, were responsible for the vast majority of the 44,000 adverse incidents
that were reported in 2008.

The EPA hopes to announce the results of its investigation of spot-on products
next month.  It will also put forth a risk mitigation proposal for PUBLIC COMMENT. 
As you probably know, EPA public comment periods are usually 30 days, but I
have urged EPA to extend it to 60 days for this important issue.

I have also been in contact with the American Veterinary Medical Association
(AVMA), the American Association of Feline Practitioners (AAFP), and the
Veterinary Information Network (VIN) and have urged them to submit comments
to the EPA when the public comment period becomes available.  I hope the
NRDC will submit comments, as well!

If the NRDC, AVMA, AAFP, and other concerned groups and individuals were
to petition the EPA to remove the highly concentrated pyrethroid-based spot-on
products from the over-the-counter market -- replacing them with products that
have a high margin of safety in all species -- it would significantly reduce the
number of adverse incidents that are reported each year from these products
and create a safer environment for toddlers who interact daily with treated pets. 

If we fail to take advantage of this rare opportunity, the EPA's risk mitigation plan
will most likely be ineffective, putting children and pets at risk for years to come.

Thank you again for the information on your campaign and for all that you are
doing to protect children and pets!

Best regards,

James TerBush
Website Administrator
www.BioSpotVictims.org



         ***************************************************************************************


Due to being a rescue family with 11 cats and 5 dogs I was shopping on UPCO for
a flea resolution.  They offer TriForce and since I was told by my Vet that UPCO is a
good company, I was sure they would not sell it if it was not safe and ordered it for
all my animals.

After putting it on (I know how to do it correctly) it was less than 8 hours when 2 of my
dogs came down with severe reaction and I had to bath them, 4 hours later the next
2 dogs started reacting by running around like crazy and drooling, we washed them
also.  We will contact UPCO and Agri Laboratories (the maker) tomorrow, because
I will not use this product again.

Brigitte  1/17/10


         ***************************************************************************************


Last night I gave my 18 month old Italian greyhound Prac-tic for small dogs
as per instructions that came with the box, she weighs 4.9 kg and has never
used Prac-tic before.


Two hours after the administering Prac-tic she became very sick and
disoriented, she was jumping up and down and could not see or hear me. Her
eyes became very swollen and she started having what looked like seizures
and chocking. She would throw her self on the floor and choke. A few minuets
later she started having hick ups which where were very frightening. She
could not stand up by her self and became very weak and basically on her way
to loosing her life. I called the vet around 9pm and we immediately took her
to the vet.


Thank goodness we got her on time to the vet, the vet administered an
antidote and that put her to sleep. Today she is still not well, when you
touch her chest she starts having those seizures again. As a result of this
episode we will be taking her back to the vet today to check on her again.
We don't know if she will be fine again and if her internal organs like the
liver etc have been affected and taking into account the medical bill that
we will have to pay for the her treatments.

I am very concerned that there are products like this out there, Prac-tic
pharmacist contacted me and I wait to see what they are going to do.

Antoinette 1/21/10


Thank you for taking the time to write.  I am very sorry to hear about your dog's reaction to Prac-tic.  If you or your vet has not already done so, I would bathe your dog with a mild dish detergent to remove as much of the Prac-tic as possible.

I have not heard of Prac-tic (it is not available in the U.S.), but it apparently contains a pesticide that belongs to the phenylpyrazole class (as does the pesticide fipronil, which
is used in Frontline and Frontline Plus (Combo) for dogs.  These pesticides are certainly capable of causing adverse reactions in pets, which can be serious.   These reactions
can occur in any dog, but aged animals and small breeds are especially at risk of overdose.

Did you use the dosage labeled for dogs 2 - 4.5 kg, or for dogs 4.5 - 11 kg?  If you used
the latter, your dog actually received twice the dosage that an 11 kg dog would have received, which increases the potential for an overdose.

Here is information from the manufacturer's website concerning Prac-tic and possible adverse reactions:

http://www.prac-tic.com/products/en/index.shtml

Excerpt:

"If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon."  It would be far better if the manufacturer was required to disclose all of the known serious effects.  However, if Prac-tic is a new product, the manufacturer may not be aware of these effects yet.

Please contact the government agency which is responsible for regulating that product
and let them know what happened.  I would also contact the manufacturer of the product (Novartis) and seek reimbursement of your vet expenses.

I hope that your dog will quickly recover.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


Hi James,

Thank you for getting back to me, we are in South Africa (Cape Town).

We have 3 Italian greyhounds and they weigh between 4.9 and 6.7 kg. The
package of the Prac-tic that we gave to them was for dogs between 4.5 -11kg
(1.1ml), the male dogs vomited after administration and the female had major
complications. The Vet told us to bathe her with dish washing soap which we
did right away.

The weight specification appears to be too broad where an 11kg and 4.5 kg
dog will get the same dose... My Vet has contacted Novartis in South Africa
and they have so far agreed to pay for the after hours consultation and
medication charges. I am not sure if my dog has suffered any internal organ
damages, so I would probably need to have some blood tests to be done to
determine this, however I would need to discuss the costs with Novartis. I
agree that they need to disclose all the side effects to inform the public.

I will be contacting the South African Bureau of Standards to report the
incident.

Thank you for the wonderful work that you are doing.

Regards,

Antoinette  1/22/10


Hi James,

Thank you for all the informaion, my dog has fully recovered and i havent
had any contact with Novartis. I have contacted the South African Poison
Control and varius regulatory organizations in South Africa and suprisingly
none of them have Prac-tic on their data base. They told me that they use
the USA data base which is updated every two to three months and Prac-tic
is not on that data base. I wont be using any spot on solutions for my dogs,
but rather some natural homeopathic herbs that does not have any of the
harmfull ingredients and its safe for all.

Best Regards,

Antoinette  1/30/10


         ***************************************************************************************


(Below is email that I sent to Drs. Foster and Smith and PetSmart on 1/25/10)


Dear Customer Service Manager,

Last April, the EPA issued an Advisory concerning a sharp increase in reports of adverse reactions from spot-on flea and tick control products and launched an investigation, which is ongoing.  Your website has absolutley no information concerning it, which is highly irresponsible.

There is information on Petco's website concerning this issue, including a link to the
EPA's website:

http://www.petco.com/petco_Page_PC_productlist_Nav_569_N_133.aspx?
CoreCat=LN_Shopping_FleaandTick

I believe that you have a duty to inform your customers about the EPA's concerns over
spot-on products.  I urge you to take action to correct this apparent oversight at your
earliest convenience.

Thank you for your consideration.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


         ***************************************************************************************


(Below is email that I received from Drs. Foster and Smith on 1/25/10)


Dear James,

Thank you for contacting Drs. Foster and Smith. We would like to apologize for any inconvenience that this matter may have caused you. We have forwarded your concerns
to our Management Team for review.

If we can be of additional assistance, please contact our Internet Customer Service Department at 1-800-381-7179, via email or on our Live Help link. Live Help is available 7:30 a.m. to 9:00 p.m. CST Monday through Friday and 7:30 a.m. to 7:00 p.m. CST weekends.

Sincerely,

Customer Care
Drs. Foster & Smith
jks


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(Below is a follow-up to a message posted by Julie on 12/30/08)


Hi Just thought I pop in & let you know that my young dog, Gizmo (Moonlight
on Lauderdale) is now almost fully recovered after his ordeal with
Frontline. In October 2007 he started to have seizures, eventually he had to
go onto Epiphen, he carried on having full grand mal cluster seizures from
October to January 2008, same time every month on the same 2 days. He went
into status on countless occasions & had to be sedated.

Then in January they stopped as suddenly as they started, he was then
gradually weaned off the Epiphen medication, by October 2008 he was off all
meds but was still not the confident little man he had been, he was so
clingy with me but I have worked away with him & he is now much more
confident again.

He is still my little shadow & is now frightened of bangs, Fireworks,
thunder & gun shot, and he was never noise sensitive before & would sit at
the window watching fireworks. We compete in Obedience Competitions & he has
now won out of Novice & is working A & B, which I feel so proud of but I am
still angry that Meriel nearly deprived me of my lovely dog, who means the
world to me.

Meriel are still not admitting that there is a problem with Frontline & yet
there are more & more reported cases of dogs & cats reacting to Frontline,
many who have had seizures because of the neuro toxin, Fipronil which can &
does cause neurological problems including seizures.

I now have a page on Facebook with links concerning the problem with
Frontline, if I can stop one animal going through what my young boy went
through then it is worth it, Meriel is not 'THE GESTURE OF LOVE YOU CAN
TRUST'. They only want to make profits they do not care about our pets.

Look what they did with the 'foot & mouth' vaccine they had here in Britain,
they were so careful not.

Keep up the good work James, this sight was a godsend when my boy's
nightmare started.

Love

Julie, Mister Moss & Gizmo xxx  1/31/10


Hi Julie,

Thank you for the update.  It's great to hear from you again.  I am very glad to hear that Gizmo continues to do well!  Thanks, too, for creating a page on Facebook about your experience with Frontline.  Many vets believe that Frontline is safe for pets, but it's good
for pet owners to be aware that it has the potential to cause adverse reactions, including lethargy, loss of appetite, vomiting, and in some cases, seizures.

Merial has long claimed that Frontline is not absorbed into a pet's bloodstream, as their website in New Zealand emphatically states:

http://frontline.nz.merial.com/faq/dogs/index.asp

Excerpt:

"Q. FRONTLINE is absorbed into my dog's bloodstream isn't it?  A. No. FRONTLINE is dispersed in the oil layer of the skin and then stored in the sebaceous glands of skin.
Fleas are not required to suck blood to be killed."

And as their website in the UK states:

http://frontline.uk.merial.com/html/all-round-protection/how-does-it-work.asp

Excerpt:

"FRONTLINE Spot On acts by direct contact with parasites and not via your pet's bloodstream. It kills fleas within 24 hours without requiring them to bite your pet."

The veterinary community has also long promulgated Merial's assertion that Frontline -- unlike over-the-counter flea control products -- does not get into a pet's bloodstream,
as this website states:

http://www.petplace.com/drug-library/fipronil-frontline/page1.aspx

Excerpt:

"It is not absorbed into the body and does not circulate through the blood stream."

In 1996, prior to the registration of the Frontline spot-on product in the U.S.A., Merial had attempted to put that claim on the product label, but the U.S. Environmental Protection Agency (which regulates the sale of pesticide products in the U.S.A.) rejected Merial's claim as blatantly false.  Here is an EPA memorandum concerning it:

http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/129121/129121-85b.pdf

Excerpt from p.7:

"The spot-on label states, 'Fipronil is not absorbed into the body, but rather collects in the oils of the skin and hair follicles. Fipronil continues to be released from hair follicles onto
the skin and fur, resulting in long residual activity.'  A previously submitted study (MRID #43577715) in which radiolabeled fipronil was administered to dogs at a high dose
(10 mg/kg) demonstrated that the chemical is absorbed systemically.  Plasma levels of radioactivity were detected from day 2 to day 30 post-treatment.  These statements
should be deleted from the label for dogs.  A similar study in cats determined that
systemic absorption was insignificant."

It's worth noting that Merial does NOT make any claims regarding the bloodstream on its U.S.A. website:

http://frontline.us.merial.com/hlp_faq.asp

I also want to pass onto you this listing of science reviews concerning fipronil.  These are U.S. EPA documents that have been released under previous Freedom of Information Act requests.  Several of them concern Frontline, including domestic animal safety studies:

http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/129121/129121.htm

Thanks again,

James TerBush
Website Administrator
www.BioSpotVictims.org


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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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