Parker Waichman LLP Injury Alerts
ARE THE NEW PESTICIDES SAFE OR JUST ANOTHER TOXIC TIME BOMB?Aug 1, 2008 As the amount of data available on the so-called “new” pesticides increases, it is becoming obvious that insects are not the only thing they are killing. Although touted as being “safe,” these insecticdes are proving to be dangerous to humans at an unacceptible rate and may be just one more example of corporate profits being placed ahead of the public’s safety.
In the past, the risks a product posed were always weighed objectively against the benefits it delivered to the consumer. Thus, a very beneficial product (a cure for AIDS, for example) would have justified a high level of risk (a death rate of 5%, possibly) since, sooner or later, the disease kills all of the people who have it. A marginally beneficial product (a cure for dandruff), however, would not have justified even a .001% death rate.
Somewhere along the way, however, the “risk to benefit” analysis became one of “risk to profit.” Thus, corporate decision makers now set their sights on what is an acceptible number of injuries or deaths when compared to the profits generated by a product. In other words, how much profit must be made before a product may have to be recalled or pulled from the market in order to justify killing or injuring a certain number of people.
Although Vioxx presented a risk profile from the very beginning that indicated the potetial for serious cardiac-related problems, the drug was approved and released anyway. (Of course this also demonstrates the ineffectiveness of the FDA in policing the pharmaceutical industry – a subject of past Newsletters). Amazingly, even a $4.8 billion settlement did not put Merck out of business and was less than two years worth of profits for that drug alone.
Automobile manufacturers are guilty of the same goulish calculations when it comes to marketing vehicles with design flaws or inadequate safety features. Chemical companies are notorious for marketing inadequately tested products that bring in billions of dollars in profits. The toy industry never lets a few choking deaths or amputated fingers stand in the way of a profitable children’s product.
Thus, it should not come a s a shock to learn that the very same disregard of public safety is at work once again when it comes to this “new” generation of pesticides.
In an ongoing series of investigative reports, The Center for Public Integrity has exposed the dangers posed by these pesticides. The Center’s first article begins with the chilling tale of the death of little 2½- year-old Amber Nickol McKeown.
When the child came down with a case of head lice, her mother put Amber in a warm bath and massaged Osco Lice Treatment Shampoo into her scalp.
By the time her mother lifted Amber from the tub, the child’s chest had already turned red. A cool bath did not help and Amber’s condition rapidly deteriorated to the point where her breathing became labored, her eyes rolled back in her head, and her skin peeled off in clumps.
When Amber arrived at the hospital she was found to have burns over 60% of her body. She was in respiratory distress, and her heart and lungs could not supply her body with oxygen.
Within three days of her bath, Amber was dead. An autopsy by the Delaware County (Pennsylvania) medical examiner concluded that Amber’s death had been caused by exposure to a class of pesticide known as pyrethrin and its related impurities.
Pyrethrins, which are extracted from the chrysanthemum plant, and their synthetic equivalent, pyrethroids, have become extremely popular in the past 10 years, and now used in thousands of consumer products including: Hartz Dog Flea & Tick Killer; Raid Ant and Roach Killer; bug-repellant clothing, flea collars, automatic misting devices, lawn-care products, and carpet sprays.
Pyrethrins and pyrethroids were developed as safer alternatives to organophosphates, which are derived from Nazi nerve gases and fond in products such as Dursban. Those chemicals were widely used in American homes until the late 1990s but are no longer approved for indoor use by the Environmental Protection Agency.
EPA data analyzed by the Center for Public Integrity (“Center”), however, “shows that the number of reported human health problems, including severe reactions, attributed to pyrethrins and pyrethroids increased by about 300% over the past decade. A Center review of the past 10 years’ worth of more than 90,000 adverse-reaction reports, filed with the EPA by pesticide manufacturers, found that pyrethrins and pyrethroids together accounted for more than 26 percent of all fatal, ‘major,’ and ‘moderate’ human incidents in the United States in 2007, up from 15 percent in 1998. Although the number of fatalities was low — about 20 from 2003 to 2007 — the amount of moderate and serious incidents attributed to the group — more than 6,000 — is significantly greater than any other class of insecticide.”
In early 2008, the EPA’s pesticide incident-reporting database was released for the first time as a result of a Freedom of Information Act request and the data from that agency and from the American Association of Poison Control Centers are similar with the number of pyrethrin and pyrethroid incidents reported to poison centers jumping 63% between 1998 and 2006 from about 16,000 to over 26,000. As with the number of adverse reactions reported to the FDA, experts believe the reports probably represent only a fraction of pesticide-related exposures.
As a result of the Center’s Investigation, the EPA has agreed to expedite its examination of the health effects of the chemicals, which it had not planned to do until 2010. The 395% increase in reported incidents (261 in 1997 to 1,030 in 2007) reflects the growing popularity of pyrethrins and pyrethroids.
Experts are now concerned that despite the belief that these insecticides are generally less toxic than organophosphates and that fatal incidents are rare, these pesticides may pose a significant risk, especially for people with asthma or allergies as well as and on the nervous systems of infants and children.
The opinion of the Medical Examiner who performed the autopsy on Amber McKeown, Frederic Hellman, is that “these are definitely not benign agents,” and that a significant number of people may be sensitive to pyrethrins and pyrethroids and experience anaphylactic reactions ranging from skin or respiratory disorders to death.
The medical literature and some recent studies suggest, people with ragweed allergies and asthma may be especially sensitive to pyrethrins and pyrethroids. Approximately 20% of Americans are susceptible to ragweed allergies and, for that reason, pyrethrins, which are extracted from chrysanthemum plants, can trigger allergic reactions. Hellman suggests that, since lice treatments are definitely not safe for everyone, anyone considering using pyrethrin or pyrethroid products first consult a physician.
SC Johnson, the manufacturer of Raid and other products containing pyrethrins and pyrethroids, and the Hartz Mountain Corporation, maker of pet products containing the compounds, declined to respond to comment on the Center’s report, although a toxicologist from an industry-run program (Pyrethrins Joint Venture) stated that pyrethrins and pyrethroids do not present any known long-term health risks since exposure periods tend to be short and because the chemicals are eliminated from the body relatively quickly. This same toxicologist is a former employee of SC Johnson and is acted as a defense expert in the McKeown case.
Although this same toxicologist claims the rising number of pyrethrin and pyrethroid incidents should not be a concern because most of the reactions are relatively minor, American Association of Poison Control Centers data also show the number of pyrethrin and pyrethroid exposures resulting in medical treatment is is approaching the number of hospital trips resulting from organophosphate exposures at their peak in the early 1990s.
While some experts are not ready to call for a ban on pyrethrin- and pyrethroid-based pesticides for residential use, they are urging more thorough studies, more specific warning labels and even that the chemicals be applied only by trained professionals.
As in the case of the FDA and the powerful pharmaceutical industry, the EPA’s Office of Pesticide Programs has been accused of reacting too slowly to emerging health threats and of being intimidated by the chemical and agricultural industries. Of course, the agency denies this and attributes its “methodical” approach to regulation and not inaction.
Although the EPA will sometimes negotiate or order an immediate product recalls, it often chooses to phase out a product; a process that can take years. Of course, in the interim the manufacturer reaps huge profits from a product that probably shpuld be off the market. This is a process that is also practiced by the FDA when it opts to order a “black box” warning to be included with package labeling rather than to order a recall. In the case of most of these drugs, the manufacturers have been permitted to earn billions of dollars in profits before the ultimate removal of the drugs from the market. The EPA refers to these as “high benefit” chemicals; and, although the agency claims to “focus all of our priorities and decision-making on protecting public health and the environment,” one has to wonder if that is really the case.
In a 2005 memorandum to his superiors, Jerome Blondell, a former health statistician in the EPA’s pesticide office, urged that manufacturers of certain products containing pyrethrins and pyrethroids be required to put explicit warnings on their labels with respect to the possibility of severe reactions for people with ragweed allergies or asthma. Blondell told the Center that the idea was rejected.
The Center reports that: “Blondell, who retired in 2005 after 30 years with the agency, said he was especially troubled by reports of people being sprayed with the pesticides by automatic misting devices, used to kill insects by some fast-food restaurants. ‘I was getting complaints of people who were sprayed in the face, and it was my position that people should not be sprayed in the face with a pesticide,’ he said. ‘Their [EPA officials’] position was, “Oh, my gosh,” when they heard names like McDonald’s and IHOP. They saw these tremendous markets, and they didn’t want me to interfere with them, so we never got anywhere with that. I was always very annoyed about that. The whole thing — it was just a bureaucratic foul-up.’”
The Center went on to report that: “Dr. Geoffrey Calvert, a senior medical officer with the National Institute for Occupational Safety and Health, worked with Blondell to place stricter labeling on misting devices. After Blondell retired, ‘There was no one to carry on the battle,’ Calvert said. ‘And before he left, he was hitting a brick wall.’”
The EPA admits it did not act on Blondell’s and Calvert’s recommendations but claims in 2006 it ordered labeling changes that were actually better than what had been proposed. While Blondell focused on recommendations dealing with people that had allergies and asthma, the agency has required a broader warning which states: “Do not enter or allow others to enter until vapors, mists, and aerosols have dispersed and the treated area has been thoroughly ventilated.”
Studies linking pyrethrins to respiratory and skin reactions among asthmatics and other populations date to the early 1900s. The industry toxicologist argues that the original crude pyrethrin extracts may have caused allergic reactions because they contained impurities that are now able to be removed by more advanced refining processes.
The Food and Drug Administration, however, which regulates shampoos containing pyrethrins and pyrethroids, has recognized the chemicals’ potential harm since 1993 when it required anti-lice shampoos to carry a warning regarding the possible effects on people with ragweed allergies. In 2003 the FDA ordered the language strengthened to: “Ask a doctor before use if you are allergic to ragweed,” the FDA warning states. “May cause difficulty breathing or an asthmatic attack.”
The industry toxicologist agrees that the warning on anti-lice shampoos “probably makes sense” because the pesticide is applied directly to the skin and may be over-applied. However, for insect sprays that are applied to a room, and other products, warnings could be “counterproductive,” by causing alarm over “relatively harmless products.”
According to the Center’s investigation: “The EPA’s pesticide incident-reporting system receives up to 6,000 reports annually — ranging from pet poisonings to water contamination — and is rarely able to confirm the details. Many of the reports are quite specific, however, and include breathing difficulties, peeling skin, hives, vomiting, and muscle aches tied to pyrethroids and pyrethrins. The data show that at least 50 deaths have been attributed to the chemicals since 1992 — 20 of them since 2003. In her master’s thesis, Jacqueline Mosby, now a branch chief with the EPA toxics program, used EPA and American Association of Poison Control Centers data, as well as reports in scientific and medical journals, to document the deaths of four people following pyrethrin or pyrethroid exposures: a 37-year-old woman who died after she gave her dog a flea bath, a 39-year-old woman who died after applying a flea treatment to her two dogs, an 11-year-old girl who died after washing her dog with a pet shampoo, and a 48-year-old woman who died after using a bug spray.”
“There are also concerns about long-term, chronic effects, which would not be reflected in the EPA data. Some researchers suspect that pyrethrins and pyrethroids may alter brain development, leading to learning disabilities and other problems. During one study, rats exposed to low doses of pyrethroids and an additional chemical, such as DEET or even common allergy medicine, developed brain damage after two months, according to Mohamed Abou-Donia, a professor of pharmacology and cancer biology and neurobiology at Duke University Medical Center who conducted the research. The EPA already considers permethrin, a popular pyrethroid, ‘a likely carcinogen” through oral exposure, although the agency also says the benefits of pest control outweigh the potential health risks.’”
Since health experts were happy to see organophosphates removed from stores, they have not spent as much time as they should worrying about pyrethrins and pyrethroids. According to the Centers for Disease Control and Prevention (CDC), high doses of organophosphates such as chlorpyrifos (marketed under the name Dursban) and diazinon (no longer permitted to be sold for residential use) may cause difficulty breathing, paralysis, seizures, loss of consciousness, coma, and death. They were targeted for phase-out by the EPA primarily because of their links to developmental disorders.
Jason R. Richardson, an assistant professor of environmental and occupational medicine at Rutgers University, is studying the effects of the neurotoxin that replaced organophosphates, pyrethroids. He stated that children generally do not metabolize toxic chemicals as well as adults, and ingested neurotoxins may lead to problems such as learning disorders. The concern with all pesticides: “Are we altering proper brain development, and can that lead to problems later on in life?” Richardson said.
According to the Center’s report: “The shampoo used on toddler Amber McKeown was made by Qualis Inc. of Des Moines, Iowa, and contained pyrethrin. Amber’s parents brought a wrongful death suit against Qualis and four retailers and distributors in 2002, claiming the child died even though they followed the instructions on the label. The case was settled for an undisclosed amount last year. Amber’s parents declined, through their lawyer, to comment for this article.”
“Qualis, which manufactured Osco Lice Treatment Shampoo, did not report Amber’s death to either the FDA or the EPA, according to agency representatives. (At the time, Qualis was not required to report the incident to the FDA; today, it would be).”
“Roxi Downing, who, according to EPA documents, is co-owner of Qualis, said the company would not comment on Amber’s death or on the safety of pyrethrins and pyrethroids.”
Although industry representatives continue to issue assurances of safety, scientists are paying closer attention to the effects of pyrethrins and pyrethroids on children. One study published in 2006 found even children fed an exclusively organic diet had pyrethroid metabolites in their systems after their parents had used pyrethroid pesticides in their homes. The study attributed this to the fact that “children tend to absorb and ingest more chemicals than adults because they frequently put their hands and other objects in their mouths and play on carpets or other treated surfaces.”
The study author stated: “The acute toxicity for pyrethroids is not well defined, so [users] think it’s safer. The problem with this assumption is that it leads to excessive use, and that’s not something I would ever recommend.” Thus, these chemicals should only be applied in homes by professionals.
In the same vein, “Dr. James Roberts, an associate professor of pediatrics at the Medical University of South Carolina who is studying the developmental effects of pyrethroids, agrees. ‘If you saw some roaches and you pick up a can of pyrethroid — especially if you really don’t like roaches, like my wife — you’re probably going to just go to town, and that’s far more than would be applied with a professional applicator,’ Roberts said. ‘I can see the argument that pyrethroids are less acutely toxic than organophosphates, but no one’s convinced me yet that the pyrethroids don’t have any long-term neurotoxicity.’”
Since the use of pyrethrins and pyrethroids is becoming so widespread, there is concern that the EPA will allow the chemicals to stay on the market even if the evidence of harm becomes significant. This was the problem with organophosphates as well.
Although it remains to be seen if these chemicals can remain in use without causuing an undue amount of harm, these new reports and data have raised concerns over our free and easy use of these new and so-called “safer” pesticides.
Parker Waichman LLP has been in the forefront of “toxic” substance litigation for many years. If you believe you or a loved one has suffered an injury as a result of being exposed to a toxic substance of any kind, please do not hesitate to contact us at www.yourlawyer.com for a free consultation.