(Beyond Pesticides, December 21, 2005) A recent study led by Elizabeth Guillette and published in Environmental Health Perspectives indicates that pesticides, such as those that effect the endocrine system, may be having more of an effect on breast development in young girls before age ten than previously thought.
The study examined precocious puberty (early development of initial breast and pubic hair development) in 50 healthy young girls ages eight to ten with no signs of birth defects or tumors living in two agricultural regions in the Yaqui Valley of Sonora, Mexico ¿ one with little to no pesticide exposure and one with pesticide exposure. The study found a distinct difference between the populations. Research showed a poorly defined relationship between the breast size and mammary gland development of the population of young girls exposed to agricultural pesticides and a robust positive relationship between breast size and mammary size among the unexposed population.
Among the girls exhibiting breast development and exposed to pesticides, palpable mammary tissue development was lacking in 12 of the 27 pubescent girls. Comparitively, non of the pubescent lesser-exposed girls exhibiting breast development lacked palpable mammary tissue.
The authors hypothesize ¿that an altered relationship between breast size, fat deposition, and mammary tissue development could result from in utero and/or childhood exposures to estrogenic or anti-androgenic chemicals as has been reported in studies of laboratory rodents.¿
The age at which females exhibit breast development has been declining in some human populations over the past fifty years. The reasons around which confound scientists. The process and timing of puberty is made up of complex interactions between neural and sex hormones. Many factors may influence the process including genetic makeup, nutritional and lifestyle factors, and possible cumulative exposure to environmental estrogens beginning in the fetus and continuing until adulthood.
The authors were careful to account for these factors in monitoring the studied populations of the two regions. Lifestyle factors are essentially the same between the populations. Prior dietary studies determine that the types of food and amount served are similar in the two areas with continual exposure through ingestion of pesticide residues on purchased foods. Both also have limited exposure to plastics, makeup and treated wood furniture that may off-gas. Prior cord blood studies in 1990 from infants born in the agricultural towns two years prior to the birth of the girls participating in the study indicated trans-placental transfer of high levels of organochlorines such as Lindane and DDT metabolites.
The standard measure to determine the staging of puberty and breast development, known as the Tanner scale, primarily involves visual scaling. In this landmark study, the authors analyzed morphometric data including breast size, mammary gland development and fat deposition of breast tissue. Results of the study indicated that using the additional variables shows distinct differences between the populations while the method of visual staging alone would show no difference. The data suggest that more in depth studies are required in order to understand the environmental influences on this increasing phenomenon.
The authors note that, ¿The role of endocrine disrupting chemicals (EDCs) on the puberty continuum has received limited attention but several reviews suggest a need for more research. The exposure of laboratory animals and wildlife to EDCs is known to alter the ratio of female to male hormones that play a dominant role in sexual development. Exposure to some estrogen mimics or anti-androgens can delay puberty in female rodents, whereas experimental exposure to low doses of estrogenic Bisphenol A, found in some plastics, speeds growth and puberty in rats.¿
Proposal on human experimentation raises ethical concerns, agency employees say
By Andrew Schneider
Baltimore Sun reporter
Originally published
December 8, 2005
The union representing
scientists at the Environmental Protection Agency added its voice
yesterday to critics who are protesting the agency's proposed rule for
human experimentation in testing pesticides.
The rule, which Congress ordered the agency to develop earlier this
year, has been criticized by several members of Congress and some EPA
personnel as allowing unethical experimentation and failing to protect
children and pregnant women.
The American Federation of Government Employees, in a letter sent last
night to EPA Administrator Stephen L. Johnson, said it is
"extremely concerned that the proposed rule has so many loopholes
and exceptions to provide any sort of enforceable ethical standards
for ... human studies."
The union said that if the rule is put into effect as proposed, it
could create "serious ethical and liability problems" for
EPA employees.
The EPA insists that the language in the new rule is completely
protective and permits only ethical actions.
"EPA has repeatedly insisted that the proposal provides for
rigorous protections, and only studies that meet rigorous scientific
and ethical standards will be permitted," said Eryn Witcher, the
EPA's press secretary. She added that all completed studies will be
reviewed "to ensure they meet all the new ethical
protections."
Many of the agency's toxicologists, scientists and health experts
vehemently disagree.
"My people feel very strongly about this," said Dave
Christenson, a member of the union's national council and president of
its Denver-based local. "The main reason that most people came to
EPA was because we wanted to protect public health. This rule is
really undercutting what EPA is supposed to stand for."
Sen. Barbara Boxer, a California Democrat who is leading the fight
against the rule, said it would allow the EPA to consider unethical
tests on pregnant women, infants and children.
"Rather than serving the interests of the pesticide industry, EPA
should heed the advice of these dedicated public servants and scrap
this deeply flawed approach," Boxer said in a statement last
night.
The period during which the public can comment on the planned rule
ends next week. The deadline for issuing the final rule is the end of
January 2006.
As proposed, the rule would govern all pesticide studies done by the
EPA, funded by the agency or conducted by industry and submitted for
EPA consideration in deciding whether to license or register a
pesticide for specific uses.
"The pesticide companies want to use this data and be able to
sell their pesticides for a whole slew of uses that they're restricted
from now, but their track records of ethical violations in what they
submit is alarming," said Christenson.
Christenson and other critics say that the portions of the proposed
rules that concern them include:
The inability of EPA scientists to ensure that industry followed
ethical guidelines, such as informing test subjects of the potential
hazard from the poisons to which they're being exposed.
The lack of a firm ban on the use of prisoners as test subjects.
Provisions that would let rules forbidding testing of infants,
children and pregnant women to be set aside on the decision of the EPA
administrator.
"Also of concern is that the rule would allow testing on children
who 'cannot be reasonably consulted,' such as those that are mentally
handicapped, does not require parental consent for testing on children
who have been neglected or abused, and accepts studies done on
children outside of the United States, which may not comply with EPA
standards," said Charles Orzehoskie, president of the union's
national council of EPA locals.
Interviews with more than a dozen EPA scientists from offices across
the country found none who objected to all human testing, only to
testing that failed to follow ethical guidelines.
The EPA employees, who asked not to be identified for fear of
retaliation, all said they feared they were going to be caught in the
middle by the ethical loopholes.
Christenson agreed.
"If this rule is adopted as written, our people will either have
to stand up for what's ethical and proper and face possible
disciplinary action or do what their manager will direct them to use
... regardless of the ethical problems," he said. "Our
scientists should never have to face this kind of moral
dilemma."
Christenson also said that "in order to give our scientists the
protection they need, all the ethical loopholes in the proposed rule
must be removed."
He added that "strong, consistent ethical rules must apply to all
EPA programs involved with human-subject research, not just
pesticides. Without this, there is no protection."
andrew.schneider@baltsun.com
(Beyond Pesticides, December 5, 2005) Photographer Laurie Tümer's work offers a snapshot of the ubiquitous presence of pesticides. Ms. Tümer has been making images that expose the presence of synthetic pesticides since 1998, when she suffered near-fatal poisoning after her New Mexico home was sprayed. While recovering, Ms. Tümer discovered the work of Richard Fenske, Ph.D., a professor of environmental health at the University of Washington's School of Public Health and Community Medicine. Dr. Fenske uses fluorescent tracer dyes and ultraviolet light to demonstrate how pesticides can spread to agricultural workers' skin, even when protective gear is worn.
By spraying tracers on her shoes and walking through her garden, or superimposing dyes onto landscape-scale canvases, Ms. Tümer uses a similar technique to illustrate how and where pesticides travel. The result of her work, a growing collection she calls "Glowing Evidence," is at once startling and stunning -- she compares the patterns in it to constellations. Critics who've seen her images exhibited in Santa Fe have called them eerie, compelling, ingenious, and haunting.
Ms. Tümer's 25-year photographic career, including a current collaboration with a blind poet, has focused on "seeing the invisible," and was featured in a 2003 documentary of that name. But as work like hers becomes more visible, she says so-called political art is really nothing new. In fact, she traces her work to cave drawings. Like that ancient art form, Ms. Tümer says, her photographs are a forum for processing information, conveying dismay, and warning others.
Laurie Tümer's photographs are available at http://www.laurietumer.com/
(Beyond Pesticides, November 18, 2005) Christmas tree farms use a variety of toxic pesticides, including Di-syston, a pesticide that has been laregely discontinued due to its toxicity. The people at the highest risk of exposure are the farm workers, the majority of whom are Latino immigrants. The two biggest producers of Christmas trees in the United States are Oregon and North Carolina. The sales in North Carolina alone total more than $100 million.
Farm workers on the tree farms are exposed to an array of dangerous pesticides that range from glyphosate (the active ingredient in Roundup) to a variety of organophosphates. One of the most dangerous pesticides used is Di-Syston 15-G, an organophosphate that can cause convulsions, dizziness, sweating, labored breathing, nausea, and unconsciousness, among other things. Bayer CropSciences voluntarily discontinued Di-Syston last year, yet it is still legal to use on Fraser firs in North Carolina and coffee In Puerto Rico. The pesticide is a powder that is traditionally applied with a bucket and measuring spoon. This method was so dangerous that the EPA threatened to ban Di-Syston. North Carolina Christmas tree growers worked hard to develop a method that used a closed system to distribute the dust and the EPA dropped the threat.
Di-Syston use has been cut back somewhat in the past few years in response to public outcries against pesticides. However other pesticides have been used in its place including dimethoate, lindane and esfenvalerate. Lindane was banned by the EPA in 2002 and has been proven to be linked to a variety of dangerous side effects including: mental/motor impairment, excitation, vomiting, stomach upset, abdominal pain, central nervous system depression, and convulsions.
Dimethoate, another organophosphate, can cause numbness, tingling sensations, headaches, dizziness, tremors, nausea, abdominal cramps, sweating, blurred vision, difficulty breathing and slow heartbeat. While esfenvalerate, a pyrethroid, is linked to dizziness, burning, itching, blurred vision, tightness in the chest, convulsions, nausea, vomiting, headaches, and weakness or tremors.
Thomas Arcury, a Wake Forest public health professor, has completed a series of studies about the effects of pesticide exposure on Christmas tree farmers. The studies found traces of chemicals used on the trees in their homes, on the hands and toys of their children, and in urine samples from the families.
By MELANIE WARNER New York Times, November 1, 2005
Customers at McDonald's restaurants in New England are about to get something a little different when they order coffee. Through a deal with Green Mountain Coffee Roasters and Newman's Own, McDonald's will soon be serving a coffee that comes from organic beans and is certified Fair Trade because it meets higher standards in the treatment of coffee workers.
The move, while still a test in a limited region, reflects a much broader trend: The growing interest among large food companies in offering organic foods along with their standard products.
General Mills markets the Cascadian Farms and Muir Glen brands; Kraft owns Back to Nature and Boca Foods, which makes soy burgers. Within the last few years, Dean Foods, the dairy giant, has acquired Horizon Organic and White Wave, maker of Silk organic soymilk. Groupe Danone, the French dairy company, owns Stonyfield Farm.
Wal-Mart wants in, too. "We are particularly excited about organic food, the fastest-growing category in all of food," Lee Scott, Wal-Mart's chief executive, said at a recent shareholder meeting. "It's a great example of how Wal-Mart can appeal to a wider range of customers."
But as organic food enters the mainstream, evolving from an idealistic subculture rooted in images of granola and Birkenstocks, a bitter debate has ensued over what exactly the word "organic" should mean. And now Congress is jumping into the controversy.
With sales of roughly $12 billion, organic food remains a niche market within the $500 billion food industry. But the sector's growing appeal to consumers has fueled a 20 percent annual growth rate in recent years, making it highly attractive to food giants looking for gains in a slow-moving business.
At General Mills, the Cascadian Farms and Muir Glen brands increased sales by 21 percent in the last year, according to the research firm Information Resources Inc., while the company's overall business was up just 1.6 percent.
Consumer groups and some organic pioneers say they are concerned that the movement - a response to the practices of corporate food production that promotes a natural chemical-free approach to farming - will become watered down unless firm standards are maintained.
The debate has been under way for several years. But last week, Senate and House Republicans on the Agriculture appropriations subcommittee inserted a last-minute provision into the department's fiscal 2006 budget specifying that certain artificial ingredients could be used in organic food.
The Organic Trade Association, an industry lobbying group that proposed the amendment and spent several months pushing for its adoption, says that the measure will encourage the continued growth of organic food.
Some advocacy groups, however, say the amendment will weaken federal organic food standards, first established under a 1990 law. Ronnie Cummins, national director of the Organic Consumers Association, calls the initiative a "sneak attack engineered by the likes of Kraft, Dean Foods and Smucker's."
One of the lobbyists for Altria, Kraft's majority owner, Abigail Blunt - the wife of Representative Roy Blunt, Republican of Missouri, who recently became interim House majority leader after Tom DeLay of Texas resigned from the post - has been working on the issue, the company says.
Dean Foods' subsidiary Horizon Organic and the J. M. Smucker Company, the owner of Knudsen and Santa Cruz Organic juices, said they supported the work by the Organic Trade Association, which represents both large and small companies in the business, but did no lobbying on their own.
The amendment injects Congress directly into the debate over whether certain artificial ingredients and industrial chemicals should be allowed in products labeled organic. In a lawsuit ruled upon in January, Arthur Harvey, an organic blueberry farmer, argued that no synthetics at all should be in food bearing the "U.S.D.A. Organic" seal. A federal judge agreed, sending shivers down the spine of many organic food manufacturers.
Katherine DiMatteo, executive director of the Organic Trade Association, said that the amendment was intended to protect the industry from the Harvey ruling and will not change the status quo. If applied, the judge's ruling would have forced many manufacturers to stop using the U.S.D.A. Organic seal and instead relabel products to state, for instance, "cookies made with organic flour" or "frozen lasagna made with organic tomatoes."
Many in the organic industry say they are willing to allow some use of synthetics in organic food. Since 2002, the National Organic Standards Board, a 15-member panel of advisers appointed by the Agriculture Department, has served as the gatekeeper for such substances. In that time, 38 have been approved, many of them relatively harmless ingredients like baking powder, pectin, ascorbic acid and carbon dioxide.
But Joseph Mendelson, legal director at the Center for Food Safety, a liberal advocacy group, says that the proposed legislation will open the door to a range of other chemicals and artificial materials, including a large category of so-called food contact substances - things like boiler additives, disinfectants and lubricants with unpronounceable names.
Most of these substances would not end up in finished products in detectable amounts. But many in the organic community say that these tools of mainstream food processing do not belong in organic production.
"We don't want organic food manufacturers having carte blanche use of the same kind of synthetics that conventional food processors use, especially when it involves things that do not appear on the ingredient panels," said James A. Riddle, chairman of the National Organic Standards Board. "I think people choose to buy organic food because they don't use all those things."
Ms. DiMatteo contends that the Organic Trade Association is not trying to loosen organic standards or take authority away from the standards board.
At the same time, Charles Sweat, chief operating officer at Earthbound Farm, the country's largest grower of organic produce, said he was concerned with the section of the spending bill that gives the Agriculture Department authority to grant temporary exemptions to allow conventionally grown ingredients like corn, soybean oil or tomatoes in organic food when organic versions are not "commercially available."
"We see this as opening up a Pandora's box," Mr. Sweat said. "Any company that can't compete because something is too expensive could go to the secretary and claim they need an exemption."
George Simeon, chief executive of Organic Valley, a cooperative of mostly small organic dairy farmers, wrestled with the high cost of organic production a little over a year ago when Wal-Mart asked for a 20 percent price cut. For three years, Organic Valley had been Wal-Mart's primary supplier of organic milk.
"Wal-Mart allows you to really build market share," Mr. Simeon said. "But we're about our values and being able to sustain our farmers. If a customer wants to stretch us to the point where we're not able to deliver our mission, then we have to find different markets."
Mr. Simeon told Wal-Mart to get a new supplier.
Dean Foods' Horizon Organic was better equipped to satisfy Wal-Mart's demands. Horizon gets about 20 percent of its production from a 4,000-cow organic dairy in Paul, Idaho, which is small in comparison with many conventional dairy farms but huge by organic standards.
Mark Kastel, senior farm policy analyst at Cornucopia, a group representing small dairy farmers, contends that Horizon is able to run such a large farm because it dilutes organic principles. Earlier this year, his group filed a petition arguing that the Idaho farm crams too many cows into a confined area, where most of them do not graze on pasture but instead consume a high-grain diet.
"These factory farms are trying to cut corners," Mr. Kastel said. "When you feed more calorie-dense grains, you get more milk."
Horizon, which also buys milk from 305 family farms, says it is making changes and will divide its Idaho operation into two separate farms so that there will be three to five cows for each acre of pasture.
"We want to meet the regulations," said Kelly O'Shea, Horizon's director of government and industry relations, "and see integrity in the organic standards."
The National Organic Standards Board has been trying to persuade the Agriculture Department to clarify its vague rule that to produce organic milk, dairy cows, besides receiving only organic feed and avoiding growth hormones and antibiotics, must have "access to pasture." It wants to require that milk labeled organic come from cows that get at least 30 percent of their diet from pasture grass for a minimum of 120 days a year.
Mr. Kastel of Cornucopia estimates that roughly 30 percent of the organic milk sold in the United States comes from cows that are not on pasture, most of them from two large dairies run by Aurora Organic Dairy, an offshoot of what was once the country's largest conventional dairy company. Organic milk is the most popular organic product and sells for up to twice the price of regular milk.
On a recent visit to Aurora's farm in Platteville, Colo., at the foot of the Rocky Mountains, thousands of Holsteins were seen confined to grassless, dirt-lined pens and eating from a long trough filled with 55 percent hay and 45 percent grains, mostly corn and soybeans.
Of the 5,200 cows on the farm, just a few hundred - those between milking cycles or near the end of their lactation - were sitting or grazing on small patches of pasture.
Aurora executives say that despite the lack of pasture, their cows are "very healthy and happy." The 10 million gallons of milk the farm produces each year are supplied mainly to supermarkets and sold under store brands like Safeway Select, Kirkland at Costco and Archer Farms at Target.
Mark Retzloff, president of Aurora Organic, said he did not agree with the National Organic Standards Board's proposed pasture rule, but added that he was planning to add 550 acres of grazing land to the farm. The company is also building a new dairy in a layout that Mr. Retzloff said would be conducive to putting thousands of cows on pasture and still milking them three times a day.
Such tensions are likely to remain whatever the new legislation allows. Sheryl O'Laughlin, chief executive of Clif Bar, which makes organic energy bars, says that while the difficulty of operating organically and finding natural ingredients often ends up raising production costs, it is also what gives the category its purity and its appeal.
"The organic industry," Ms. O'Laughlin said, "has got to put pressure on itself to find alternative solutions."
“Johnson, who is working to shepherd a rule that allows limited third-party human pesticide exposure studies through the agency on an expedited basis, already faces pressure following similar concerns raised by congressional leaders and environmentalists… the agency is moving to allow submission of studies involving human subjects from other realms, such as academia or industry…”
Risk Policy Report
November 1, 2005
EPA's children's health advisers are recommending that the agency examine and remove possible loopholes in the agency's proposal to ban pesticide studies that intentionally dose pregnant women and children. The Children's Health Protection Advisory Committee (CHPAC) drafted a letter Oct. 26 to EPA Administrator Stephen Johnson outlining "a number of weaknesses and ambiguities" in the proposed ban that they say will undercut the ban's intent.
Johnson, who is working to shepherd a rule that allows limited third-party human pesticide exposure studies through the agency on an expedited basis, already faces pressure following similar concerns raised by congressional leaders and environmentalists. However, EPA has, in many cases, been unresponsive to CHPAC's concerns.
At an Oct. 25-26 meeting, CHPAC members opted to strengthen an earlier draft letter encouraging EPA to remove language that they say could allow dose-response tests on children and fetuses. The letter also recommends the agency remove language that CHPAC says gives the EPA administrator unchecked authority to waive the ban. Relevant documents are available on InsideEPA.com.
EPA's proposal seeks to address how the agency will handle third-party pesticide studies that include human test subjects. The agency does not conduct any tests on humans, nor does it fund such tests. However, the agency is moving to allow submission of studies involving human subjects from other realms, such as academia or industry, after Congress included language in the agency's fiscal year 2006 spending law requiring the agency to issue a rule on acceptable test procedures.
One controversial part of EPA's proposed rule considers the intentional dose studies, in which volunteers are exposed to pesticides in order to determine any potential health risks. The agency included in the proposal several measures designed to ensure tests are ethical. For example, the agency has proposed to create an internal review board to examine the studies to be sure they correspond to ethics guidelines.
However, Democratic lawmakers and environmentalists have voiced concern that the rule, if enacted, would open the door to studies that could put children at risk. This prompted the agency to issue a proposed ban on any studies involving pregnant women or children.
Now, CHPAC members say that in its current format, the proposed ban fails to block such studies because several provisions in the rule undercut the ban. For example, the Oct. 26 draft letter states that the proposed ban could still allow "studies involving pregnant women, fetuses or children, as long as the tests are not conducted with the 'intention' of submitting them to EPA" under the Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) or the Federal Food, Drug & Cosmetic Act (FFDCA), which dictate tolerance levels for pesticides and the registration process.
"As such, intentional dosing studies of pesticides which are conducted for the purposes of review by a foreign government or a state could be conducted and subsequently submitted to EPA for review under FIFRA or FFDCA, without running afoul of the new regulations," the draft CHPAC letter states.
CHPAC says that one solution to this concern is for EPA to "extend the prohibition of third-party intentional dosing studies of pesticides using pregnant women and children as subjects to studies conducted for any purpose and submitted to EPA under any statutory authority," according to the letter.
The draft letter also outlines other criticisms, including a provision in the proposed ban that gives the EPA administrator broad authority to waive any protective measures contained in the language of the regulation.
CHPAC notes that the agency's proposal empowers the administrator to waive any or all of the restrictions. The ban language states, "In appropriate circumstances, the Administrator may, under [section] 26.101(e) waive the applicability of some or all of the requirements of these regulations for research of this type." The committee urges the agency to remove such "sweeping authority" from the administrator when the studies involve children.
The draft letter also addresses concerns over the ethics of any studies involving children, saying the committee "could not foresee any situations in which it would be ethical to intentionally dose pregnant women, fetuses or children." CHPAC also encouraged EPA to grant "a degree of authority" to the Human Studies Review Board, an internal board EPA is considering creating to handle ethical issues involved in human pesticide test data.
EPA officials did not return calls seeking comment on the effect a letter from CHPAC might have on the proposal.
CHPAC has weighed in on other issues before but has had little success in winning change at EPA. For example, committee members were highly critical of EPA's power plant mercury rule. Johnson asked CHPAC to review guidance documents for the mercury rule when he served as assistant administrator for the agency. But EPA has yet to respond to two letters, dated Nov. 8, 2004, and Jan. 4, 2005, which stem from that request. However, most letters written since 2000 have at least received an official response, according to the agency's Web site.
The committee will work to finalize the language of the letter before it is sent to Johnson.
FOR IMMEDIATE RELEASE, October 25, 2005
Contact: Jay Feldman, Beyond Pesticides, 202-543-5450
Lara Cushing, Center for Environmental Health, 510-594-9864
http://www.beyondpesticides.org
Public interest groups today petitioned the Food and Drug Administration (FDA) to ban the antibacterial agent triclosan in household products because of evidence that it causes health and environmental effects and leads to antibiotic resistance. The chemical, marketed widely to protect children from germs, is found in antibacterial soaps, deodorants, toothpastes, cosmetics, fabrics and plastics.
Washington, DC, October 25, 2005 Concerned about health effects, public health and environmental groups today asked FDA to pull from the market widely used household products that contain the germ fighting chemical triclosan. Scientific studies dispute the need for the chemical and link its widespread use to health and environmental effects and the development of stronger bacteria that are increasingly difficult to control. The groups are asking FDA to recognize the urgency of the problem and expedite action to ban household triclosan use after a FDA advisory panel found last week that the chemical provides no additional health protection than soap and water.
Jay Feldman, Executive Director of Beyond Pesticides, the lead
petitioner, said, The failure to regulate triclosan as the law requires
put millions of people and the environment at unnecessary risk to toxic
effects and elevated risk to other bacterial diseases.
Senior National Institutes for Health scientist (retired) in microbiology
and immunology and widely published in his field, Cecil Fox, Ph.D.,
stated, "I am troubled that governmental review of triclosan has
failed to scrutinize the development of resistant microorganisms (and the
by-product, antibiotic-resistant microbial populations), and the
transport and accumulation of triclosan residues through skin and mucosal
absorption. FDAs failure is a national scandal," Dr. Fox said.
With enormous medical concern about antibiotic resistant disease, doctors
will tell you that nothing beats good old soap and water, said Michael
Green, Executive Director of the Center for Environmental Health. FDAs
inaction on triclosan is short-sighted; the agency needs to take a longer
view towards protecting public health and the environment.
The household use of triclosan results in contamination of the nations waterways, according to the petition, with triclosan among the most prevalent contaminants not removed by typical wastewater treatment plants. William Arnold, Ph.D. Associate Professor, University of Minnesota, Department of Civil Engineering, explained, Upon triclosan exposure to sunlight, two of the products generated are 2,8-diclorodibenzodioxin and 2,4-dichlorophenol. If triclosan was exposed to chlorine and then sunlight, there is the potential for more highly chlorinated products to be produced.
The petitioners include Beyond Pesticides, Center for Environmental Health, Advocates for Environmental Human Rights, Alaska Community Action on Toxics, Breast Cancer Action, Breast Cancer Fund, Campaign for Safe Cosmetics, Citizens Environmental Coalition, Environmental Health Fund, Indigenous Environmental Network, Natural Resources Defense Council, Maryland Pesticide Network, Northwest Indiana Toxics Action Project, San Diego Oceans Foundation, Womens Voices for the Earth, and the organic retailer Seventh Generation, Inc.
The petition and background is posted at http://www.beyondpesticides.org.
Finds Few Popular Health and Beauty Brand Ingredients Are Industry-Screened for Safety
(WASHINGTON, Oct. 17) - Through a new, interactive personal care product safety guide, "Skin Deep," consumers can consult brand-by-brand safety ratings for more than 14,000 products. "Skin Deep" fills the information gap left by an industry that markets thousand of products with ingredients that have not been assessed for safety by either industry or government health experts. Those safety decisions are made behind closed doors, guided by an industry-funded panel, without the benefit of peer-reviewed pre-market testing. The industry's own panel has screened only 11 percent of 10,500 ingredients for safety.
The searchable "Skin Deep" database features in-depth information on shampoos, lotions, deodorants, sunscreens and other products from almost 1,000 brands, built from a core of 37 toxicity and regulatory databases.
Consumers can use "Skin Deep" to create customized shopping lists - products free of fragrances or carcinogens, for instance - while manufacturers can construct one-of-a-kind safety assessments, rating all their product ingredients at once to aid reformulation plans.
"Most of us expect that the products we find on store shelves have been tested for safety, but the government has no authority to require tests," said Environmental Working Group (EWG) Vice President for Science Jane Houlihan. "An average adult is exposed to over 100 unique chemicals in personal care products every day - these exposures add up."
There is no industry-wide safety standard for personal care products or ingredients, and in a September 29 response to an EWG petition, the Food and Drug Administration (FDA) said it would not set one. Industry now decides what is safe for consumers, and it does so with no guidelines whatsoever.
"Without federal oversight or standards, companies should inform consumers of their own internal studies, and how they decide if a product or ingredient is safe enough to sell," Houlihan said.
The "Skin Deep" database is available at www.ewg.org/reports/skindeep/.
(Beyond Pesticides, October 11, 2005) European children are absorbing dangerous chemicals into their blood from computers, textiles, cosmetics and electrical appliances, according to a new study released last week by WWF. Generation X, WWF's first European Union—wide family testing survey, found a total of 73 man-made hazardous compounds in the blood of grandmothers, mothers and children from 13 families in 12 countries.
The highest number of chemicals, an average of 63 and including some which are now banned like DDT, was recorded among the oldest generation tested, while the middle generation -- the mothers -- registered only 49. But tests on the children in the 13 families showed an average of 59 dangerous chemicals -- many of them new products in widespread use like flame retardants, the WWF said.
"It shows that we are all unwittingly the subjects of an uncontrolled global experiment, and its is particularly shocking to discover that toxic chemicals in daily use are contaminating the blood of our children," said WWF specialist Karl Wagner. "How much more evidence is needed before industry and European politicians accept that these hazardous chemicals cannot be adequately controlled?" he asked.
In the tests, blood samples from the 13 families were analyzed for 107 different man-made persistent, accumulative or hormone-disrupting chemicals from five main groups.
Of 31 different flame retardants of another type analyzed in the survey, 17 were found among the children tested compared to 10 among the grandmothers and eight among the mothers.
The antibacterial agent triclosan was found in 16 family members (out of 39 total) spanning all 3 generations. Triclosan is found in hundreds of common everyday products, including nearly half of all commercial soaps. In addition to soaps, triclosan is found in deodorants, toothpastes, cosmetics, fabrics and plastics. Triclosan has also been found in the umbilical cord blood of infants and in breast milk of mothers.
The tests matched conclusions of similar sampling last year from 14 EU environment and health ministers which showed contamination by 55 chemicals, some banned years ago and others in daily use.
The latest survey, WWF said, raises the question of whether future generations will be more exposed to potentially cancer- producing and endocrine-disrupting chemicals that accumulate in human bodies to increasing levels over a life-span.
The latest tests were carried out in Belgium, where two families were involved, and on one family each from Denmark, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Poland, Sweden and Luxembourg.
Some Doctors Alarmed by Hidden Chemicals at Schools
Oct. 11, 2005 — - Kellianne King was a healthy, vibrant little girl until she started preschool. That's when she started to suffer from headaches, sinus infections, chest pains and seizures, says her mother, Kathy King.
It was a heart-wrenching time for the family. "She would stand on her bed and she would just scream, 'You have to -- you have to help me. Someone has to help me.' And we couldn't do anything," King said.
And Kellianne, now 13, couldn't enjoy many of the pleasures of being a kid.
"I feel like I didn't get to do much," she said. "I mean, I can ride a bike and read a book now but when I was little, I never got to do that. I learned how to do those things much later. So it was hard."
No one, it seemed, could figure out what was making the little girl so sick. "We took her to all the best doctors and they were just perplexed by her," King said. "They really just couldn't pinpoint what was wrong,"
Mystery Illness Revealed
When Kellianne was in the first grade, her parents learned the painful truth: There were serious air quality problems in her school that had sickened dozens of students and teachers.
"I was shocked that the only place, the only place I trusted to leave her was what was making her sick," said King.
Dr. Phillip Landigan chairs the Department of Community and Preventative Medicine at Mt. Sinai School of Medicine in New York. He is one of many doctors alarmed by hidden toxins in schools.
"Today, too many chemicals are put into schools that have never been tested for the possible impacts they have on young children," Landigan said.
Simple leaks can breed deadly mold behind walls and trigger an asthma attack; pesticides used to kill insects and weeds can damage a child's developing nervous system, lowering IQ and affecting attention span.
"Children live down on the floor," Landigan said. "They crawl on the rug. They're constantly putting their little fingers in their mouths. And all of those actions increase the child's exposure."
Alarming School Experiment
Just how quickly kids get exposed to toxins in school became clear when "Good Morning America" conducted an experiment in a classroom at P.S. 8 in New York.
First, we applied Glo-Germ, a non-toxic powder only visible under ultra-violet light, in areas where pesticides are most likely to be sprayed or to settle, like baseboards, windowsills and desktops. Then we invited the kids to play. After only 20 minutes, we showed them the stunning results.
Using UV light, we found traces of Glo-Germ all over their clothes, hands and faces.
"It was actually scary to see how germs can spread, toxins can spread all over the place," said teacher Olivia Ellis.
Kids spend nearly 90 percent of their time indoors. Yet there are no specific federal requirements limiting the use of toxins, such as pesticides, in schools, which is why it often takes teamwork to get a school to clean up its act and its air.
Patricia Berkey is the principal of Hastings Elementary School in Massachusetts, where Kellianne attended school and was exposed to toxins. "I think families need to feel comfortable when they send their children off to school that they're sending their children to a safe and healthy environment," Berkey said.
That school took action and, nine years later, Hastings is an award-winning example of a healthy environment school.
A health and safety team, composed of Berkey, a parent, teacher, school nurse and maintenance technician, regularly inspects the entire school looking for leaks, dirty ventilation filters and making certain that only non-toxic cleaners are being used in the classrooms.
"It's a really good feeling to know that if you take a little time out locally in your schools that the impact can be really far-reaching," said King.
How far-reaching? Thanks to King and other parents' efforts, every school in her district has similar toxin-fighting teams, protecting the health of some 3,500 students -- including Kellianne.
"I feel very proud to have a mom that would do that for her kid instead of just giving up and saying, 'Oh well, I can live with them being like this forever,'" Kellianne said. "Just fighting. Also, not just for me but for other kids."
Copyright © 2005 ABC News Internet Ventures
BY FRAN HENRY
c.2005 Newhouse News Service
Go on and admit it. The yard next door really rankles you, with its profusion of dandelions in spring, followed by a bountiful harvest of crabgrass and clover. And then the whole mess browns out in mid-July because no one bothers to water it.
Get used to it. Your neighbor, whether he knows it, is in the vanguard of a movement that prizes natural lawns where children can sit and pick four-leaf clovers, where dogs can nibble grass, and where no sign reads: Keep off the grass for 24 hours.
The truth be told, however, your neighbor's environmentally pure lawn could also be aesthetically pleasing.
There are signs that the multibillion-dollar lawn-care industry is going to help him out.
It's already happening in Canada, where 71 municipalities have banned the use of lawn pesticides -- an umbrella term for herbicides, insecticides and fungicides.
In June, Scotts Canada met the gaping hole in its market by introducing EcoSense, a line of organic lawn and gardening products, including weed-control sprays, insect dusts and a lawn fertilizer. The company is a subsidiary of Scotts, based in Marysville, Ohio.
While there are no plans to sell the EcoSense line in the United States, the U.S. division plans to renew its efforts to develop a line of organic lawn and gardening products, spokesman Jim King said.
Scotts' news comes as numerous U.S. environmental groups are stepping up their campaigns to ban or restrict the use of lawn pesticides.
Americans use pesticides lavishly -- an estimated 90 million pounds each year on lawns and gardens, not including products used by lawn-care and pest-control professionals, according to the Audubon Society.
Pressure to use the products comes from the big players in the lawn-care industry, said Diana Post of the Rachel Carson Council, named for the author of the 1962 blockbuster book "Silent Spring."
"A lot of money has gone into promotion and they've been effective," Post said.
Pesticides are poisons that don't necessarily stay put. When it rains, they run off the land into streams and groundwater, the U.S. Geological Survey's Pixie Hamilton said.
They also drift when they're dusted or sprayed, and they can be tracked indoors onto floors where children and pets play. Research shows pesticide residues may remain for up to a year.
A growing body of scientific evidence links pesticide exposure with a vast array of medical problems, including asthma, childhood leukemia, birth defects, brain cancer, soft tissue sarcoma, non-Hodgkin's lymphoma, behavioral and learning disorders, and delayed motor development.
Children are particularly vulnerable because they breathe more air per pound of body weight than adults, creating greater lung exposure to fumes and vapors. And, because children are small, they absorb pesticides at a higher concentration. Their brains and nervous systems are less able to repair damage caused by these toxins.
Even when the toxins exist at low levels, they are dangerous, University of Wisconsin researcher Warren Porter said. "Ultralow doses at the right point in time can have devastating effects on the future development of embryos, as many top-notch scientists have demonstrated."
The perceived dangers have resulted in the following campaigns:
The EPA is in the process of evaluating the risks of older pesticides and assessing their risks, spokeswoman Enesta Jones said.
About 78 percent of the pesticides have been reviewed, with some re-registered and others canceled or deregulated, she said. The studies used in the recertification process are supplied by the manufacturers of the chemicals under review.
The EPA maintains that re-registered pesticides are safe when used according to directions. The risks associated with older pesticides, Jones said in an e-mail, "are mitigated by changes in their use brought about by changes in product labeling."
But only about half of consumers actually read the label before they use a pesticide, said Paul Parker, of the Center for Resource Management, a nonprofit organization focused on environmental problems. "The information on the labels is written for attorneys concerned about liability issues, not people," he said.
Although the EPA mandated label changes in 1996, the possibility of human error persists.
For example, pesticide use in or near schools caused more than 1,500 children and school employees to become ill between 1998 and 2002, according to a study in July's Journal of the American Medical Association.
These stories of illness are all too disquieting to F. Herbert Bormann, co-author of "Redesigning the American Lawn: A Search for Ecological Harmony" (Yale University Press, $18).
"I would venture to say that people tending their lawns don't consider the big picture: that their piece of the world is part of the planet."
Oct. 6, 2005
(Fran Henry is a reporter for The Plain Dealer of Cleveland. She can be contacted at fhenry@plaind.com.)
30 Sep 2005
A study led by an Emory University researcher concludes that an organic diet given to children provides a "dramatic and immediate protective effect" against exposures to two pesticides that are commonly used in U.S. agricultural production. The results were published on a recent online version of the scientific journal Environmental Health Perspectives (EHP).
Over a fifteen-day period, Dr. Chensheng "Alex" Lu and his colleagues from Emory University, the University of Washington, and the Centers for Disease Control and Prevention specifically measured the exposure of two organophosphorus pesticides (OP) - malathion and chlorpyrifos - in 23 elementary students in the Seattle area by testing their urine.
The participants, ages 3-11-years-old, were first monitored for three days on their conventional diets before the researchers substituted most of the children's conventional diets with organic food items for five consecutive days. The children were then re-introduced to their normal foods and monitored for an additional seven days.
"Immediately after substituting organic food items for the children's normal diets, the concentration of the organophosphorus pesticides found in their bodies decreased substantially to non-detectable levels until the conventional diets were re-introduced," says Dr. Lu, an assistant professor in the department of environmental and occupational health, Rollins School of Public Health, Emory University.
During the days when children consumed organic diets, most of their urine samples contained zero concentration for the malathion metabolite. However, once the children returned to their conventional diets, the average malathion metabolite concentration increased to 1.6 parts per billion with a concentration range from 5 to 263 parts per billion, Dr. Lu explains.
A similar trend was observed for chlorpyrifos. As the average chlorpyrifos metabolite concentration increased from one part per billion during the organic diet days to six parts per billion when children consumed conventional food.
The researchers note that to ensure that any detectable change in dietary pesticide exposure would be attributable to the organic food rather than the change in diet, the substituted organic foods were items the children would have normally eaten as part of their conventional diet.Organic food items were substituted for the conventional diet of fresh fruits and vegetables, juices, processed fruits or vegetables (e.g. salsa), and wheat-based or corn-based products (i.e. pasta, cereal, popcorn, or chips).
Former research has linked organophosphorus pesticides to causes of neurological effects in animals and humans.
"Recent regulatory changes aiming to minimize children's exposures to pesticides have either banned or restricted the use of many organophosphorus pesticides in the residential environment. However, fewer restrictions have been imposed in agriculture," Dr. Lu says.
According to the annual survey by U.S. Department of Agriculture Pesticide Data Program, organophosphorus pesticide residues are still routinely detected in food items that are commonly consumed by young children.
The study was funded by the United States Environmental Protection Agency.
The Environmental Health Perspectives (EHP) is an open access journal published by the National Institute of Environmental Health Sciences. The full article is available at ehp.niehs.nih.gov/docs/2005/8418/abstract.html
By Andrew Schneider
Sun National Staff
Originally published September 14, 2005
WASHINGTON - The Environmental Protection Agency's new rules on human testing, which the agency said last week would "categorically" protect children and pregnant women from pesticide testing, include numerous exemptions - including one that specifically allows testing of children who have been "abused and neglected."
The rules were revised under intense criticism from environmental groups, scientists and members of Congress, after the disclosure that subjects in some earlier pesticide studies were unaware of what they were being exposed to and, in many cases, did not know why the testing was being done.
One study would have used $2 million from the chemical industry to measure the pesticide consumption of infants in low-income households in Florida.
In unveiling the new rules last week, the EPA promised full protection for those most at risk of unethical testing.
"We regard as unethical and would never conduct, support, require or approve any study involving intentional exposure of pregnant women, infants or children to a pesticide," the rule states.
But within the 30 pages of rules are clear-cut exceptions that permit:
The EPA provided little clarification yesterday in response to questions about the exemptions.
In a written response, officials said that abused and neglected children were specifically singled out to create "additional protection" for them, although they did not elaborate.
And they denied there were any exceptions to the prohibitions on testing women and children. They added that the new rules meet all the requirements set by Congress last spring and summer in a series of often heated hearings.
But some of those who led the hearings disagreed.
"For the first time in our nation's history, the EPA has proposed a program to allow for the systematic and everyday experimentation of pesticides on humans," Rep. Henry A. Waxman, a California Democrat and leading critic of the testing policies, said in a statement yesterday. "Moreover, the proposed program is riddled with ethical loopholes."
Sen. Barbara Boxer, another California Democrat, who also demanded improvements in protecting human test subjects, voiced similar criticism.
"The EPA proposed rule on human testing has several large loopholes that undermine the very purpose of the rule. No wonder the pesticide companies are saying such nice things about it," Boxer said.
"This is unethical and contrary to recent direction from Congress."
Many critics believe that the agency is buckling to the pesticide industry, which has faced much more stringent testing standards under regulations approved in 1996.
The exemptions are "obviously driven by the pesticide industry's goal of relaxing pesticide safety standards," said Aaron Colangelo, a senior staff lawyer with the Natural Resources Defense Fund, which has been involved in 18 lawsuits against the pesticide industry and government agencies.
Public health experts, including Colangelo, said they had no idea what the EPA meant by some of the language in the exemptions - how the agency might define a "direct benefit" to a child, for example.
"The rule says it's acceptable to test children if there is a direct benefit," Colangelo said. "How can any child possibly benefit from exposure to pesticides? What was EPA thinking about?"
"This is ethically abhorrent, and the way EPA described this rule is clearly misleading," he said. "In fact, the rule expressly approves intentional chemical tests against these [at-risk groups] in several circumstances."
Richard Wiles, senior vice president of Environmental Working Group, said "EPA's proposal is the [pesticide] industry's dream, and the public's nightmare."
Physicians and lawyers offered possible explanations for some of the exemptions.
A study that could mean higher crop yields could be justification enough for the EPA to cite a "public health benefit" under the exemptions, said Dr. Alan Lockwood, an expert in human-testing ethics and past president of Physicians for Social Responsibility.
"This would be a public health benefit, even though the exposed children may experience an adverse effect."
Scientists question the continued use of POEA in Roundup, citing data showing harmful effects to frogs.
September 7, 2005
Glyphosate herbicides, such as Monsanto's popular Roundup, have an environmentally friendly reputation because their active ingredients are relatively nontoxic and degrade rapidly in the environment. But University of Pittsburgh biologist Rick Relyea is challenging this view. He has found that Roundup at environmentally relevant concentrations kills or harms tadpoles because of the presence of the surfactant POEA, an ingredient that is defined as inert and doesn't appear on the label (Ecol. Appl. 2005, 15, 618–627; 1118–1124).
Relyea's work is one of several studies that shed light on the behavior of "inerts" in the environment, a topic largely ignored by the U.S. EPA, say many environmental toxicologists inside and outside the agency. In 1995, EPA changed the listing of POEA (polyethoxylated tallow amine) from an inert of "unknown toxicity" to one that is of "minimal concern". According to the agency, "the current use pattern in pesticide products will not adversely affect public health or the environment". The agency presently does not have plans to further revise the classification, say EPA officials interviewed for this story.
"The inerts evaluation for environmental effects is EPA's dirty little secret," says one agency scientist who requested anonymity. "POEA is likely to be the tip of the iceberg, but we don't know because we don't have data. The agency assures us that everything's okay. On the basis of what? Not data. Then, to make matters worse, the inerts aren't even listed on the label."
An agency official who asked not to be quoted admitted that the environmental effects of inerts are not a high priority for EPA. This is not because the agency is ignoring important data, the official says. Instead, EPA regulators say that any problems are not significant or are handled through usage restrictions that appear prominently on product labels.
EPA's approach generally makes sense, argues environmental toxicologist Keith Solomon with the University of Guelph (Canada). EPA assumes that pesticide active ingredients are typically potent chemicals and most inerts are fairly benign, which Solomon says is generally true. Glyphosate, with its very low toxicity, violates this assumption. As a result, the inert surfactant makes a big difference to the overall toxicity of any formulation with the compound. However, this case is probably unusual, he states.
For regulatory purposes, pesticide formulations consist of two broad components—"active" ingredients that target the pest or weed and "inerts" or "other" ingredients. Inerts, which often comprise the bulk of the pesticide formulation, improve the efficacy or handling characteristics of the product, for example, by helping the active ingredient dissolve, easing application, or improving the pesticide's adherence to plant leaves. POEA in Roundup enables the herbicide to penetrate the waxy surfaces of plants, according to Monsanto scientific director Eric Sachs.
EPA has four lists of inert ingredients: inerts of toxicological concern, potentially toxic inerts, inerts of unknown toxicity, and minimal-risk inerts. An indication of the hazards that many inert ingredients may pose is the extent to which these same chemicals are regulated under other U.S. laws, says Caroline Cox, staff scientist with the advocacy group Northwest Coalition for Alternatives to Pesticides in Eugene, Ore. In March, she scrutinized the more than 1800 chemicals on EPA's list of inerts of unknown toxicity and found that 75 are identified as hazardous by the Clean Air Act, 52 under Superfund, 64 in the Clean Water Act, 43 on the Toxics Release Inventory, and 78 with the Toxic Substances Control Act. In addition, 292 inerts of unknown toxicity are registered by EPA as active ingredients in other pesticides.
EPA requires information on possible toxicity for active ingredients but not for inerts.
Moreover, most inert ingredients are not identified on labels because manufacturers maintain that these constitute trade secrets. The legality of this position is still being considered by the courts, according to Cox, whose organization has spearheaded the call for disclosure of inerts on pesticide labels.
One of the chemicals that appears on the inerts list but is also considered an active ingredient is PBO (piperonyl butoxide), which is a synergist that makes pyrethroid pesticides 10x more lethal to black flies and mosquitoes. Studies of commercial pyrethroid formulations by Eric Paul's group at New York state's Rome Field Station show that PBO also enhances the toxicity of these pesticides to fish. However, EPA's recent PBO risk assessment fails to look at the synergist in conjunction with the active ingredient. EPA's risk assessment misses the point, says Paul. "An environmental evaluation needs to know how these things work together. We know there is a synergistic effect on target species. This alone suggests the need to evaluate effects of a formulation on nontarget species," he says.
In the case of POEA, Monsanto disputes the concentrations and conditions Relyea used in his experiments. However, at least four other papers dating back to 1988 point the finger of blame at POEA (Lancet 1988, 1, 299; Arch. Environ. Contam. Toxicol. 1999, 36, 193–199; Environ. Pollut. 2001, 114, 195–205; Chemosphere 2003, 52, 1189–1197.) A fifth, more recent paper reports that tadpoles exposed in the lab to POEA concentrations common in the environment (0.6 milligrams per liter [mg/L] and 1.8 mg/L) for 42 days, which is the estimated aquatic half-life of the surfactant, exhibited delayed metamorphosis and developmental abnormalities (Environ. Toxicol. Chem. 2004, 23, 1928–1938)
Steve Bradbury, director of EPA's Office of Pesticide Programs Environmental Fate and Effects Division, acknowledges that some inerts, including POEA, may have toxicological profiles that cause concern. However, usage restrictions for products containing POEA clearly state on the label that it should not be applied directly to water.
Label restrictions miss the point, say Relyea and others, who note that chemicals in the environment often stray from their intended locations. For example, when U.S. and Canadian foresters spray glyphosate herbicides from helicopters and planes onto forest to eliminate plants after clear cutting, mist inevitably drifts off target. Frogs living and breeding in wetlands and small ponds in or near forests are unintentionally exposed to formulations containing POEA, these scientists note. A study of aerial applications of Roundup found that small wetlands can receive up to 1.9 mg of acid equivalents per liter (Environ. Toxicol. Chem. 2004, 23, 843–849).
Several environmental risk assessments conducted for glyphosate herbicides did not include information from Relyea's work and more recent studies (J. Toxicol. Environ. Health, Part B 2003, 6, 289–324; Glyphosate: Human Health and Ecological Risk Assessment Final Report, SERA TR 02-43-09-04a, U.S. Department of Agriculture Forest Service, 2003). These assessments acknowledge the more potent aquatic toxicity of POEA and the lack of monitoring, sublethal effects, and environmental occurrence data. However, they conclude that the risk of adverse effects in the aquatic environment is generally small.
Nevertheless, an Australian governmental review in 1996 found that the POEA in Roundup presented a toxic risk to tadpoles and frogs in shallow water, where dilution doesn't occur. "The use of the POEA surfactant is an anachronism in light of its well-documented toxicity and the availability of substitute surfactants with demonstrated lower toxicities," argues biologist Reinier Mann, who at the time worked in Australia and is now at the Universidade de Aveiro (Portugal).
"We know [POEA is] toxic," states Canadian Wildlife Service toxicologist Bruce Pauli, who is the corresponding author of the 42-day exposure study. "We hope there's not enough in the water to cause a problem." But at a time when amphibian populations are declining dramatically for unknown reasons, he asks: "Is that really protecting the environment?" —REBECCA RENNER
By Andrew Schneider
Sun National Staff
August 11, 2005
WASHINGTON - New rules drafted by the Environmental Protection Agency to protect human subjects of scientific tests came under harsh criticism yesterday from environmental groups, government scientists and members of Congress, who called the proposal misleading, dangerous and industry-friendly.
The 76-page draft, obtained by The Sun, was hurried to completion this month after Congress denounced this summer standards for EPA-related tests and noted health risks and ethical lapses in tests performed by the pesticide industry.
An introduction to the document promises more stringent rules, including tighter controls on human studies, the creation of an independent panel to evaluate the ethics of proposed studies, and protections preventing pregnant women and children from being used as test subjects.
EPA press secretary Eryn Witcher said she could not comment on specific criticism of the proposed rules because they are being reviewed. But she called the proposal "landmark regulation that will extend very rigorous protections."
The language of the rules falls short of those promises, according to EPA toxicologists, health experts and lawyers at the agency's headquarters and at its regional offices.
"This is a very important ethical, scientific and clinical issue, and they are going to try to fool the American public about its intent," said an EPA toxicologist who requested anonymity for fear of retribution. "It's a magician's trick."
Richard Wiles, senior vice president of the Environmental Working Group, which for decades has fought for better pesticide controls, said the rules "will give the pesticide industry essentially all the power."
The proposed rules are "so full of loopholes that almost any conceivable study would be allowed, and this may lead to an increase in pesticide levels in our food and concomitant damage to health and environment," said Dr. Alan Lockwood, a neurologist who serves with Physicians for Social Responsibility.
'Slap in the face'
The proposals were described by an environmentalist as a "slap in the face" to Congress, which had faulted the agency for moving forward on an earlier draft that legislators considered seriously flawed.
"Then EPA goes ahead and submits the same thing to the White House for approval," said Eric Olson, senior attorney for the National Resources Defense Council, which has worked closely with Congress on human testing issues. "It's clearly a violation of Congress' direct prohibition on all testing of pregnant women, infants and children."
Congress reviewed 22 EPA-related human studies conducted by the pesticide companies and found that test subjects didn't know what they were being exposed to and, in many cases, had no idea why the testing was being done.
They also found no evidence in many of those cases that the testing followed accepted international ethical standards.
Florida study
Congress' concern over EPA's pesticide program was piqued this year when it learned about an agency project that, using $2 million from the chemical industry, would have measured the pesticide consumption of infants in low-income households in Florida.
EPA would have paid the parents every time they sprayed pesticides. Children in the program were to be given teething rings and slices of cheese because researchers knew the youngsters would drop them, then place them in their mouths. In addition, the project was to have given parents about $1,000 and video equipment to monitor and record their children's activities.
The program was canceled after it surfaced during the confirmation hearings of EPA Administrator Stephen L. Johnson.
Concerns about human testing standards for EPA-related projects forged unusual agreement recently among Democrats and Republicans. Last month, the Senate approved legislation, 60-37, halting the agency's human testing projects and demanding that it issue detailed rules within 180 days.
'Flawed approach'
Late yesterday, Sen. Barbara Boxer, a California Democrat, wrote EPA Administrator Johnson, demanding changes, saying the proposal failed to address congressional concerns.
She urged Johnson to "abandon its flawed approach prior to proposing the rule.
"This proposal fails to adequately ensure that people, including the most vulnerable among us, are protected from unethical industry tests in which human subjects swallow, inhale, are sprayed with, or are otherwise exposed to toxic pesticides," said the senator, who, with members of the House, have been fighting EPA on the issue.
California Rep. Henry Waxman yesterday called the proposal "deeply flawed" and said it "would allow unethical pesticide experiments on humans.
"Some of the industry experiments violate our most basic values, and EPA should stop looking to exploit loopholes and spend its time complying with the important ethical principles that govern human research," he said.
Review process
The proposal is being evaluated by the White House Office of Management and Budget, which will offer recommendations. Once the EPA makes additional changes, the proposal will be open for public comment, said Witcher, the EPA press secretary.
Once the plan is finalized, the EPA looks forward to "addressing all questions and concerns," said Witcher, the agency spokeswoman.
Most critics of the proposal say it leaves too much open to interpretation.
"Our concern is once you allow testing on these people who should be most protected, and you say there are only very narrow types of tests that are prohibited, it will be the wild west for testing of these prohibited classes of people," said Wiles, of the Environmental Working Group.
The National Resources Defense Council's Olson agrees. The rules would prohibit "toxicity" tests, which determine how human subjects react to increasing levels of pesticides. But they would continue to permit exposure to pesticides in other types of tests.
"They will continue to allow testing on pregnant women, infants and children, including orphans and wards of the state if it's not considered toxicity testing," said Olson.
Test results
Critics also say the proposed rules are unclear about whether the EPA can use the results from the 22 tests in question and others that may surface. EPA says it will decide on a case-by-case basis.
But Wiles says that is a dangerous approach.
"Regardless of how great or dedicated the people in EPA may be, each human study comes along with its own army of lobbyists and industry scientists to explain why this is the test that has to be accepted," he said.
Those inside the agency said they were most concerned by the EPA's absence of institutional review boards. Most federal agencies rely on the independent panels, with members of varying expertise, to weigh in on ethical policies and answer to the head of the agency. The EPA appoints a single person to fulfill that role.
"You have to have an independent IRB," Wiles said. "That's how all medical research is done."
"It's all about money," Wiles added. "Basically the human studies are designed to keep their products on the market, to avoid health restrictions to keep making money from the sale of pesticides. That's what it's all about. It allows the use of pesticides that might otherwise be banned."
Croplife America, the lobbying group and trade organization of the pesticide industry, disagrees.
No profit motive
In an interview with The Sun last month, officials of the group said that human testing had nothing to do with profits and was done only to increase safety.
Several of the EPA scientists interviewed said they weren't concerned by the industry's profits, but rather the health consequences of increasing pesticide use. Weakening public health protections from pesticides, they said, will allow higher concentrations of the chemicals in the environment, foods and drinking water.
Copyright (c) 2005, The Baltimore Sun
Link to the article:
http://www.baltimoresun.com/news/health/bal-te.testing11aug11,1,5869652.story?coll=bal-home-headlines
Contact: Karen Hoffmann
412-624-4356
klh52@pitt.edu
PITTSBURGH—As amphibians continue to mysteriously disappear worldwide, a University of Pittsburgh researcher may have found more pieces of the puzzle. Elaborating on his previous research, Pitt assistant professor of biological sciences Rick Relyea has discovered that Roundup®, the most commonly used herbicide in the world, is deadly to tadpoles at lower concentrations than previously tested; that the presence of soil does not mitigate the chemical's effects; and that the product kills frogs in addition to tadpoles.
In two articles published in the August 1 issue of the journal Ecological Applications, Relyea and his doctoral students Nancy Schoeppner and Jason Hoverman found that even when applied at concentrations that are one-third of the maximum concentrations expected in nature, Roundup® still killed up to 71 percent of tadpoles raised in outdoor tanks.
Relyea also examined whether adding soil to the tanks would absorb the Roundup® and make it less deadly to tadpoles. The soil made no difference: After exposure to the maximum concentration expected in nature, nearly all of the tadpoles from three species died.
Although Roundup® is not approved for use in water, scientists have found that the herbicide can wind up in small wetlands where tadpoles live due to inadvertent spraying during the application of Roundup®.
Studying how Roundup® affected frogs after metamorphosis, Relyea found that the recommended application of Roundup® Weed and Grass Killer, a formulation marketed to homeowners and gardeners, killed up to 86 percent of terrestrial frogs after only one day.
"The most striking result from the experiments was that a chemical designed to kill plants killed 98 percent of all tadpoles within three weeks and 79 percent of all frogs within one day," Relyea wrote.
Previous studies have determined that it is Roundup®'s surfactant (polyethoxylated tallowamine, or POEA, an "inert" ingredient added to make the herbicide penetrate plant leaves) and not the active herbicide (glyphosate) that is lethal to amphibians.
This research was funded by the National Science Foundation, Pitt's McKinley Fund, and the Pennsylvania Academy of Science.
###
8/3/05/blg
By PETER WALDMAN
Staff Reporter of THE WALL STREET JOURNAL
July 22, 2005; Page B2
Legal restrictions have lowered Americans' exposure to certain toxic substances such as lead and cigarette smoke, according to a report by the Centers for Disease Control and Prevention. But dozens of other potentially dangerous chemicals -- from pesticides to the fragrance s in cosmetics -- appear to be nearly ubiquitous in Americans' bloodstreams, the agency found.
The CDC's third and largest survey of Americans' exposure to
environmental chemicals tested the blood and urine of roughly 2,400
people for traces of 148 different chemicals. The results of the
so-called biomonitoring study underscored a big challenge for
environmental scientists and regulators: They now know a lot more
about which industrial chemicals are in the human body, and at what
levels, than they do about which compounds actually pose danger.
"This study is a breakthrough; it's just the information we haven't had," said Thomas Burke of Johns Hopkins University, chairman of a National Academy of Sciences panel on applying and interpreting biomonitoring data. "Yet this is still in its infancy. Our ability to detect chemicals is way ahead of our ability to identify risks."
Specifically, the CDC found a sharp decline in the blood lead levels in children ages 1 to 5 -- the most vulnerable group to lead's effects on the brain. CDC Director Julie Gerberding attributed this to the banning of leaded gasoline in the U.S. and other legal measures. Likewise, antismoking regulations have helped drive down exposure to cotinine, a metabolite of nicotine in second-hand tobacco smoke, by about 70% -- except for Africans-Americans, whose cotinine levels remain roughly twice as high as that of whites and Hispanics, the CDC said.
The agency reported widespread exposures to dozens of different pesticides, with the highest levels generally reported in children. Among the 38 new chemicals tested in the latest survey, the CDC looked at exposures to a class of common pesticides called pyrethroids -- used in Raid roach killer, among others -- and found that 76% of the population sampled had the chemical in their bodies.
According to preliminary calculations by Margaret Reeves, senior scientist with the advocacy group Pesticide Action Network, children ages 6 to 11 had metabolites of one pesticide in their blood, called chlorpyrifos, that were more than four times as high as the Environmental Protection Agency's safe level for that age group.
For three types of phthalates, a class of chemicals used in various products including cosmetics, pills and plastics, 5% of the population had levels exceeding levels recently associated with genital abnormalities in boys. For cadmium, a metal emitted in tobacco smoke and fossil-fuel exhaust, the CDC said 5% of Americans older than 19 had urinary levels approaching the dose linked to damaged kidney function and bone-mineral density.
With so many different chemicals in the body, said Johns Hopkins's Dr. Burke, the cocktail effect is still far from understood. "Do different but similar compounds act cumulatively, synergistically? We don't know. What we do know from this report is that people are the great integrators of their total environment," he said.
Write to Peter Waldman at peter.waldman@wsj.com3
URL for this article: http://online.wsj.com/article/0,,SB112196974641892385,00.html
Copyright 2005
Dow Jones & Company, Inc. All Rights
Reserved
(Beyond Pesticides, July 21, 2005)
Today, the Cen ters for Disease Control and Prevention (CDC) is set to release its Third National Report on Human Exposure to Environmental Chemicals, detailing the latest data on the "body burden" of chemicals carried by U.S. residents. The chemicals measured in the Third Report include organophosphate pesticides, organochlorine pesticides, pyrethroid pesticides, and herbicides; lead, mercury, cadmium, tungsten, and other metals; polycyclic aromatic hydrocarbons (PAHs); dioxins, furans, and polychlorinated biphenyls (PCBs); phthalates; phytoestrogens; and, environmental tobacco smoke.
This is the first CDC report to track levels of synthetic pyrethroid pesticides, now the most widely used class of insecticides. During a press conference, CDC director Julie L. Gerberding, MD, stated that she was not surprised at the levels at which pyrethroids were detected in the study given that they are used so ubiquitously in the U.S. Dr. Gerberding did not link the exposure to any specific health effects, but said the data would be used in further studies to track the adverse effects of these chemicals.
The report finds the following pesticide and/or their metabolites in greater than 50% of the subjects tested: permethrin, cypermethrin, deltamethrin, chlorpyrifos, methyl and ethyl parathion, 2,4 -D, lindane, chlordane, 2,5-dichlorophenol (moth balls) and DDT. Metabolites of the insect repellant DEET was detected in about 10% of subjects.
Environmentalists and public health advocates are concerned, but not also surprised by the huge body burden of toxic chemicals presented in the preliminary report data. "We live in a toxic world - we breathe air contaminated by pesticide drift, eat food with dangerous pesticide residues and drink water contaminated by leaching chemicals. At the same time that scientists are detecting these toxic chemicals in our bodies, we are learning that environmental illnesses such as cancer and asthma are on the rise," said John Kepner, project director at Beyond Pesticides. Environmentalists say the report only reinforces the need to reduce and eliminate exposure to these chemicals in our homes, schools and workplaces, on our lawns and in our food system.
Of the 48 commonly used pesticides in schools, which include many of the chemicals CDC has detected in the human body, 22 are probable or possible carcinogens, 26 have been shown to cause reproductive effects, 31 damage the nervous system, 31 injure the live r or kidney, 41 are sensitizers or irritants, and 16 can cause birth defects. Of the 36 most commonly used lawn pesticides, 13 can cause cancer, 14 cause birth defects, 11 cause reproductive problems, 21 are neurotoxic, 15 are kidney and liver toxicants, and 30 are sensitizers or irritants.
CDC also finds that people carry in their bodies pesticides that are linked to asthma, chemicals that both cause and promote respiratory illness. In a scientific review of the connection between asthma and pesticides, Beyond Pesticides found that 16 million people suffer from asthma in the U.S. alone, including 1 of 8 school-aged children. Asthma is the leading cause of school absenteeism and the third most common cause for hospitalization in children under 15. Low-income populations, minorities, and children living in inner cities experience disproportionately higher morbidity and mortality due to asthma.
The Third Report covers the years 1999-2000 and 2001-2002 and provides blood and urine levels for 148 environmental chemicals, including 43 pesticides, measured in people who participated in CDC's National Health and Nutrition Examination Survey (NHANES). This is an increase from 116 chemicals profiled in CDC's second report, released in January 2003, and 27 in the < A href="http://www.noharm.org/details.cfm?ID=745&type=document" target=_blank>first report, released in March 2001. In addition to covering more substances, the third report provides trend information for a few substances, as well as improved breakouts by categories such as age, sex, and race.
For example, the Third Report finds 3-Phenoxybenzoic acid, a metabolite of the pyrethroid insectici despermethrin, cypermethrin and deltamethrin, in more than 50% of the population. However, exposure was not uniform across the board. While exposure by age and gender had only slight variations (6-11 yrs - 0.325 μg/L urine concentration, 12-19 yrs 0.354 μg/L, 20-59 yrs - 0.314 μg/L; and, males - 0.328 μg/L, females - .0.315 μg/L), race played a greater factor (Mexican-Americans - 0.297 μg/L, non-Hispanic Blacks - 0.507 μg/L, non-Hispanic whites - 0.298 μg/L).
CDC's first two exposure reports have demonstrated that: 1 in 12 women of child-bearing age have levels of mercury above the EPA safe level; levels of phthalates found in soft PVC plastic (DEHP) are higher in children than adults, and nearly all types of phthalates, especially those found in cosmetics, levels are higher in women than in men; and, Mexican-Americans have three times the level of DDT in their bodies compared to non-Hispanic Whites.
Last week, the advocacy organizations Environmental Working Group and Commonweal released a similar study that found 287 industrial chemicals, pesticides and other pollutants in umbilical cord blood, confirming that chemical exposure begins in the womb. The new study, Body Burden: The Pollution in Newborns, tested 10 American Red Cross cord blood samples for an unprecedented 413 industrial and consumer product chemicals. EWG's Vice President for Research Jane Houlihan says that had it been able to test for more chemicals, it would almost certainly have detected them.
By Christine Stapleton
Palm Beach Post Staff
Writer
http://www.palmbeachpost.com/news/content/nation/epaper/2005/07/14/m1a_peststudy_0714.html
Thursday, July 14, 2005
In a benchmark study released today, researchers found an average of 200 industrial compounds, pollutants and other chemicals in the umbilical cord blood of newborns, including seven dangerous pesticides - some banned in the United States more than 30 years ago.
The report, Body Burden - The Pollution in Newborns , by the Washington, D.C.-based Environmental Working Group, detected 287 chemicals in the umbilical cord blood of 10 newborns. Of those chemicals, 76 cause cancer in humans or animals, 94 are toxic to the brain and nervous system and 79 cause birth defects or abnormal development in animal tests.
*76 chemicals that cause cancer in humans or animals. *94 that are toxic to the brain and nervous system. *79 that cause birth defects or abnormal development in animal tests.
The findings are especially important in Florida, where farmers use more pesticides per acre than any other state.
"What's most startling is that we have such a wide range of compounds in us the moment we are born," said Tim Kropp, senior toxicologist for the project. "Babies don't use any consumer products, they don't work in a factory and yet they're already starting off with a load of these chemicals."
Among the most pervasive pesticides found: 4,4'-DDE a contaminant and byproduct of DDT, banned in the United States in 1972 but still used in other parts of the world to control mosquitoes; hexachlorobenzene, a fungicide widely used on wheat until 1965 when chemical giants Bayer and Dow voluntarily discontinued production of the likely carcinogen; and Dieldrin, routinely used on corn and cotton until banned in 1974 except for treatment of termites.
Scientists blame the presence of the pesticides in the babies' blood on the fact that many of the compounds take decades to break down and some are still used in foreign countries, which export produce to the United States.
For example, Mirex was used to control fire ants and as a flame retardant in plastics, rubber, paint, paper and electrical products from 1959 to 1972. It sticks to soil for years and contaminates fish and animals living near treated sites. Aldrin and Dieldrin, probable carcinogens, have not been banned or restricted in most of Central and South America. While most countries have banned imports, Brazil and Venezuela still allow the importation and restricted use of Dieldrin.
Besides the pesticides, chemicals from two widely used household products - Teflon and Scotchgard - were found in every baby tested. PFOS, the active ingredient in the stain-repellent Scotchgard, does not break down in the environment and has a strong tendency to accumulate in humans. While PFOS has not been found conclusively to be toxic to humans, lab tests have shown it can cause birth defects and deaths in laboratory animals given high doses. 3M, the sole manufacturer of Scotchgard, voluntarily agreed to phase out PFOS products in 2000 after pressure from the EPA.
PFOA, the chemical used to make such non-stick products as Teflon, is present in the blood of 95 percent of all Americans. Last month, an Environmental Protection Agency advisory panel released a report finding PFOA a likely carcinogen. The chemical has also been linked to birth defects and liver damage in lab tests.
Although the amounts of some of the chemicals detected were extremely small, the results are still troubling to experts, since no one knows how much of any given chemical - much less a mixture of chemicals - could affect a human fetus. What research exists has shown that chemical exposure in the womb can be dramatically more harmful than exposure later in life.
In 2003, the EPA updated its cancer risk guidelines, finding that carcinogens are 10 times as potent to babies and that some chemicals are up to 65 times more powerful in children.
The EPA also sets maximum exposure limits for many dangerous chemicals. However, the research behind those tolerances came from studies of "healthy men in the middle of life" - not pregnant women and newborns, said Dr. Alan Greene, a faculty member and pediatrician at the Stanford University School of Medicine.
"We've only recently begun to consider the effects on the elderly, women and kids," Greene said. "We don't know what the safe levels are for these groups. Kids have been ignored for far too long."
Greene, whose family eats only organic produce, said the study should be "alarming and reassuring" for pregnant women.
"It's alarming because there were so many chemicals found, and we don't know their health effects, but at the same time the data coming in shows that decreasing your exposure to these substances does make a difference," he said.
There have been dramatic drops in the levels of DDT and its byproducts since it was banned in 1972. A 2002 study of preschoolers in Seattle showed that children who ate a conventional diet had nine times the level of pesticides in their urine as counterparts who ate organic, Greene said.
The Environmental Working Group conducted the study in collaboration with Commonweal, a California nonprofit health and environmental research institute. EWG is a nonprofit environmental watchdog/research organization that, according to its Web site, claims to "bring to light unsettling facts that you have a right to know. It shames and shakes up polluters and their lobbyists. It rattles politicians and shapes policy. It persuades bureaucracies to rethink science and strengthen regulation. It provides practical information you can use to protect your family and community."
Critics, such as David Martosko, research director Center for Consumer Freedom, said "a typical EWG study is a pseudo-science ruse meant to scare the ordinary American to death about the food we eat and the air we breathe." CCF is a nonprofit coalition of restaurants, food companies and consumers "working together to promote personal responsibility and protect consumer choices."
"They never met a square on the periodic table of elements that they couldn't turn into a sound bite," Martosko said. EWG "represents a political movement in the U.S. that wants to dump the world's finest farming system in favor of organic agriculture, a backward scheme that threatens to build a bridge back to the 19th century," Martosko wrote on the CCF Web site.
Prior studies have tested for chemicals and pesticides in umbilical cord blood. However, the Environmental Working Group study is the first to attempt to detect so many chemicals, pollutants and pesticides - a total of 413. Of these, 307 had never been targeted in cord blood tests.
The study focused on cord blood, which mirrors the mixtures of chemicals the baby was exposed to while in the mother's womb. Before the cord is cut, the equivalent of 300 gallons of blood a day will flow through it, providing the baby with nutrition and removing waste.
In the Environmental Working Group study, the cord blood from 10 randomly selected, healthy babies born in August and September 2004 in U.S. hospitals was collected by the American National Red Cross as part of the organization's volunteer cord blood collection program. The costs of the testing - $10,000 per sample - and the lack of laboratories equipped to perform the testing prevented the organization from testing more samples.
The organization hopes the findings will encourage the Centers for Disease Control in Atlanta to include testing of newborns in its National Exposure Report, due out later this month.
"This is the first time anyone has looked at this wide a range of chemicals, and in a way, that's kind of sad," said Kropp. "Whether it's the Food and Drug Administration or the EPA, you would think they would want to know the basic attributes of the most sensitive population. If these children are being born with these chemicals, we need to know they're safe. We shouldn't have to wait until children are harmed to do something."
June 30, 2005 — By Andrew Taylor, Associated Press
WASHINGTON — The Senate voted to block the Environmental Protection
Agency from using studies that expose people to pesticides when
considering permits for new pest killers.
By a 60-37 vote, the Senate approved a provision from Sen.
Barbara Boxer, D-Calif., that would block the EPA from relying on such
testing -- including 24 human pesticide experiments currently under
review -- as it approves or denies pesticide applications.
The Bush administration lifted a moratorium imposed in 1998 by
the Clinton administration on using human testing for pesticide
approvals. Under the change, political appointees are refereeing on a
case-by-case basis any ethical disputes over human testing.
The tests include a 2002-04 study by University of
California-San Diego in which chloropicrin, an insecticide that during
World War I was a chemical warfare agent, was administered to 127 young
adults in doses that exceeded federal safety limits by 12 times.
New EPA rules under development envision permitting the agency
to accept data from human tests on children, pregnant women, newborns,
infants and fetuses. Even newborns of "uncertain viability" could be
tested under the draft EPA rule.
Boxer's proposal would block the EPA from using data taken
from human testing for the budget year starting Oct. 1. It would also
bar the agency from conducting such testing.
"Let's use this time to throw out this rule that they're
drafting which is immoral on its face because it would allow EPA itself
to test pregnant women and fetuses," Boxer told reporters. "And let's
go back to the basic rules of science and morality."
The vote came as the Senate debated a bill funding the EPA and
Interior Department budgets. The House approved identical language when
considering its version of the bill last month.
Ordinarily, approval by both House and Senate would ensure the
language is retained in the final version of the bill. But GOP floor
manager Conrad Burns, R-Mont., opposed Boxer's amendment, and as lead
Senate negotiator on the bill, is well-positioned to kill it in future
talks with the House.
Burns countered with an amendment, adopted 57-40, in favor of
careful human testing. It instructs the EPA to try to make sure any
human testing is conducted ethically and that the benefits outweigh the
risks to volunteers.
The EPA is developing rules, slated to be issued by 2006, on
the use of human subjects for testing pesticides in the wake of a 2003
decision by the U.S. Court of Appeals for the District of Columbia that
sided with pesticide manufacturers. The court ruled that the EPA cannot
refuse to consider data from manufacturer-sponsored human exposure
tests until it develops regulations on it.
Boxer and Bill Nelson, D-Fla., had held up the confirmation of
EPA Administrator Stephen Johnson until he promised to cancel a
pesticide study in Florida. Over the study's two years, EPA had planned
to give $970 plus a camcorder and children's clothes to each of the
families of 60 children in Duval County, Fla., in what critics of the
study noted was a low-income, minority neighborhood.
Source: Associated Press
Scientists will call on European leaders today to take urgent action to speed up regulation of the thousands of gender-bending chemicals in use across the continent.
The harmful effects of these chemicals - called endocrine disrupters - have been a growing concern in recent years but today's move will be the first time the scientific community has raised its concerns with politicians and the public at large.
The Prague Declaration, named after a meeting of more than 100 toxicologists and chemists in Czech Republic last month, and due to be launched today in Brussels, will state that legislation on the safe use of chemicals does not go far enough and lack of scientific evidence of the harmful effects of these chemicals must not delay political action.
"Many of these chemicals affect development in the womb," said Andreas Kortenkamp, a toxicologist at London University's School of Pharmacy and one of the signatories of the declaration. "The problem is that these effects are not captured in routine testing," he said.
Endocrine disrupters are a diverse group of several thousands of chemicals - such as polychlorinated biphenyls (PCBs) and dioxins - used in everything from pesticides to flame retardants, cosmetics to pharmaceuticals. Some of them alter the function of hormones in animals, either blocking their normal action or interfering with how they are made in the body. Since hormones regulate things like growth and body development, the potential for damage is clear.
The link between these chemicals and detrimental effects in wildlife is well-established: pseudo-hermaphrodite polar bears with penis-like stumps, panthers with atrophied testicles and male trout with eggs growing in their testes have all been documented as the probable result of endocrine-disrupting chemicals in the environment.
"Wildlife provides early warnings of effects produced by endocrine disrupters, which may as yet be unobserved in humans," the declaration said.
Scientists have long suspected that the presence of these chemicals is also responsible for the high prevalence of fertility problems in European men, and for the rise in the number of breast and testicular cancers.
Last month, scientists in America confirmed this fear with evidence that a class of chemicals known as phthalates - used to make plastics more pliable - may harm the development of unborn baby boys. Researchers had known for some time that high levels of these chemicals were harmful, but the latest study suggests that even normal levels - those commonly found in toys, plastic bags and clingfilm - could disrupt the development of male reproductive organs.
"Our interest is to highlight the need to deal with endocrine disrupters in EU regulation," said Dr Kortenkamp.
Forthcoming EU legislation on the safety of chemicals -known as Reach (Registration, Evaluation and Authorisation of Chemicals) - does have some clauses on endocrine disrupters, but scientists are concerned that the proposals do not go far enough.
They said that, while the EU has invested money into finding out how endocrine disrupters harm animals and plants, there has been little thought on what to do with the results.
Dr Kortenkamp said that there must be a more systematic approach to identifying and controlling the use of endocrine disrupters. "The level of proof required in Reach is far too high - it would only capture chemicals where it is more or less already proven that there are effects," he said.
"That is, in our opinion, not good enough. We feel we need to act pretty soon, even though some of the evidence isn't too hard cast."
Neither does Reach consider the potential cocktail effects of these chemicals. "If you continue evaluating chemicals one by one, you run the risk of erroneously concluding that there are no effects," said Dr Kortenkamp.
The declaration stops short of suggesting a ban on endocrine-disrupting
chemicals. "Regulatory action can mean anything from labelling at the very soft
end to banning at the very hard end," said Dr Kortenkamp.
By JOHN HEILPRIN
Associated Press Writer
June 16, 2005, 9:04 AM
EDT
WASHINGTON -- Data from two dozen industry
tests that intentionally exposed people to poisons, including one involving a
World War I-era chemical warfare agent, are being used by the Environmental
Protection Agency in approving and denying specific pesticides.
The
controversial data come from 24 human pesticide experiments submitted to the EPA
by companies seeking pesticide permits. The data, provided by the EPA to
congressional officials, is being studied under a policy the Bush administration
adopted last November to have political appointees referee on a case-by-case
basis any ethical disputes over human testing.
Aides to two California
Democrats, Sen. Barbara Boxer and Rep. Henry Waxman, compiled and reviewed EPA
data on 22 of the cases.
"Nearly one-third of the studies reviewed were
specifically designed to cause harm to the human test subjects or to put them at
risk of harm," the aides concluded in a 38-page report and accompanying
documents provided Wednesday to The Associated Press.
The report said
scientists conducting the experiments "failed to obtain informed consent (and)
dismissed adverse outcomes," adding that the tests "lacked scientific validity."
One study in 2002-2004 by University of California-San Diego researchers
administered chloropicrin, a soil insecticide that during World War I was a
chemical warfare agent, to 127 young adults. Trade-name products for it and
mixtures of it -- such as Timberfume, Tri-Con, Preplant Soil Fumigant and
Pic-Chor -- must carry a "danger" warning label.
Most were college
students and minorities who were paid $15 an hour to be put in a chamber or have
the vapor shot into their nose and eyes after signing consent forms warning they
should anticipate "some irritation in the nose, throat and eyes that could be
sharp enough to cause blinking and tearing."
"Because you will be
participating in an experiment, we must apprise you that there may be some risks
that are currently unforeseeable," the consent form read.
However, doses
120 times the hourly limit established by the Occupational Safety and Health
Administration were ingested by the test subjects, according to the
congressional aides' report.
Another study dosed eight people with the
pesticide azinphos-methyl for 28 days, and everyone reported headaches,
abdominal pain, nausea, coughing and rashes, the report said.
Boxer said
the report "proves the Bush administration is encouraging dangerous pesticide
testing on humans with no standards," despite the EPA's new policy.
EPA
spokeswoman Eryn Witcher said Wednesday that the agency "values the importance
of the scientific and ethical issues surrounding human studies and is expediting
a public rulemaking process to comply with a federal court decision."
The U.S. Court of Appeals for the District of Columbia ruled in 2003 in a suit
brought by the pesticide industry that the EPA cannot refuse to consider data
from manufacturer-sponsored human exposure tests until it develops regulations
on it.
Agency officials said last November that a new rule on human
testing data would be issued by 2006, and until then each study would be looked
at and accepted unless it is fundamentally unethical or has significant
deficiencies.
Human tests, in the view of pesticide makers, provide more
accurate results than those using animals about the risks of the products to
people and the environment. The companies that use them say they follow safety
guidelines set by Congress, EPA, courts and scientific groups.
The EPA
for decades used industry studies gathered from human tests to help set
pesticide exposure levels. Officials say they still accept the data but don't
rely on it for their decision-making.
Last year, the National Academy of
Sciences recommended that the EPA establish a human studies review panel to look
at such studies, both before and after they're conducted.
* __
WSU findings show that disorders can be passed on without genetic mutations
Friday, June 3, 2005
By TOM PAULSON
SEATTLE POST-INTELLIGENCER REPORTER
It's just a study involving a few rats with fertility problems in Pullman, but the findings could lead to fundamental changes in how we look at environmental toxins, cancer, heritable diseases, genetics and the basics of evolutionary biology.
If a pregnant woman is exposed to a pesticide at the wrong time, the study suggests, her children, grandchildren and the rest of her descendants could inherit the damage and diseases caused by the toxin -- even if it doesn't involve a genetic mutation.
"As so often happens in science, we just stumbled onto this," said Dr. Michael Skinner, director of the center for reproductive biology at Washington State University.
Skinner's team at WSU and colleagues from several other universities report in today's Science magazine on what they believe is the first demonstration and explanation of how a toxin-induced disorder in a pregnant female can be passed on to children and succeeding generations without changes in her genetic code, or DNA.
"We were quite surprised ... we've been sitting on this for a few years," said Skinner, who is expected to present his findings today at a scientific meeting in San Diego.
The report in Science, entitled "Epigenetic Transgenerational Actions of Endocrine Disruptors and Male Fertility," also sounds like an attempt to avoid attention. That's unlikely to work. The findings prompt serious and, in some cases, disturbing questions about a number of basic assumptions in biology.
The standard view of heritable disease is that for any disorder or disease to be inherited, a gene must go bad (mutate) and that gene must get passed on to the offspring.
What Skinner and his colleagues did is show that exposing a pregnant rat to high doses of a class of pesticides known as "endocrine disruptors" causes an inherited reproductive disorder in male rats that is passed on without any genetic mutation.
It's not genetic change; it's an "epigenetic" change. Epigenetics is a relatively new field of science that refers to modifying DNA without mutations in the genes.
"It's not a change in the DNA sequence," Skinner explained. "It's a chemical modification of the DNA."
Scientists have known for years about these changes to DNA that can modify genes' behavior without directly altering them.
One form of epigenetic change is natural. Every cell in the body contains the entire genetic code. But brain cells must use only the genes needed in the brain, for example, and kidney cells should activate only the genes needed for renal function.
Cells commonly switch on and off gene behavior by attaching small molecules known as methyl groups to specific sections of DNA. The attachment and detachment of methyl groups is also an important process in fetal development of the male testes and female ovaries -- which is where Skinner got started on this.
But the common wisdom has been that any artificially induced epigenetic modifications will remain as an isolated change in an individual. Because no genes get altered, the changes cannot be passed on.
"We showed that they can be," Skinner said.
The experiment got its start four years ago by accident. His lab was studying testes development in fetal rats, using a fungicide used in vineyards (vinclozin) and a common pesticide (methoxychlor) to disrupt the process. A researcher inadvertently allowed two of the exposed rats to breed, so the scientists figured they'd just see what happened.
The male in the breeding pair was born with a low sperm count and other disorders because of the mother's exposure to toxins. No surprise. But the male offspring of the pair also had these problems, as did the next two generations of male rats.
"I couldn't explain it," Skinner. This wasn't supposed to happen.
The scientists didn't tell anyone about their finding and continued, for the next two years, to confirm that it was real and to find an explanation. Eventually, they documented that a toxin-induced attachment of methyl groups to DNA in the mother rat was being passed on to offspring.
"In human terms, this would mean if your great grandmother was exposed to an environmental toxin at a critical point in her pregnancy, you may have inherited the disease," Skinner said.
While the study was focused on a heritable disorder of reproduction in rats, he said there's every reason to believe this can happen for other diseases -- such as cancer.
"There has been this speculation that the increased rates of some cancers may be due to environmental factors, but they've never been able to describe a mechanism to explain this," Skinner said.
The findings also suggest a reconsideration of one of the basic tenets of evolutionary biology -- that evolution proceeds by random genetic change.
The standard view is that the environment has no direct influence, except in how it may favor or discriminate against the creatures with the latest genetic mutations.
The WSU study, Skinner said, suggests the possibility that environmental factors such as toxins may also directly cause heritable changes in creatures. "Epigenetics may be just as important as genetics in evolution," he said.
(Beyond Pesticides, May 23, 2005) The U.S. House of Representatives on a voice vote added a provision to an appropriations bill which forbids EPA to "accept, consider, or rely on third-party intentional dosing human studies for pesticides or to conduct intentional dosing human studies for pesticides. The bill, sponsored by Reps. Hilda Solis (D-CA) and Tim Bishop (D-NY) as House Amendment 191 to EPA's 2006 Appropriations Bill, H.R. 2361 (Department of the Interior, Environment, and Related Agencies Appropriations Act, 2006), passed on May 19. Read floor statements. The House bill language will need to be negotiated with the Senate before it becomes law.
The bill puts lawmakers at odds with a controversial proposed policy of the Bush Administration that currently allows on a case-by-case basis data from pesticide tests on humans to be used to support the registration of pesticide products. This is a reversal of the Clinton Administration. The Bush Administration in December 2001 had backed off plans to reverse the Clinton ban on human testing and then did an about face. See industry position. Representing the pesticide industry, CropLife sued EPA on February 12, 2002 (U.S. Court of Appeals D.C. Circuit Petition for Review (February 12, 2002) -- CropLife America, et al. v. EPA), arguing that the agency could not ban human testing. In that case, the Court of Appeals ruled on June 3, 2003 (CropLife America v. EPA) that EPA could not issue a ban without notice or the opportunity for public comment. EPA contracted with the National Academy of Sciences, which released the report, Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues, on the subject outlining.
Instead of moving ahead with its position to ban human testing, on February 8, 2005 the Bush Administration published in the Federal Register its proposal to allow human testing. Prior to this, on May 7, 2003, EPA issued an advance notice of proposed rulemaking (ANPR) on human testing (68 FR 24410) in which EPA announced its intention to undertake notice-and-comment rulemaking on its consideration of or reliance on research involving human participants. The ANPR also invited public comment on a broad range of issues related to this subject. EPA received over 600 submissions in response to the ANPR. Approximately 15 were from pesticide companies, pesticide users, and associated trade associations and groups. These comments mostly favored the agency's use of data from scientifically sound, ethically appropriate studies conducted with human participants. Several of these groups urged EPA to apply the Common Rule to human research conducted for EPA by third parties. About 60 submissions came from religious groups, farm-workers' and children's advocacy groups, and environmental and public health advocacy organizations. Most of these groups generally opposed EPA's consideration of results from human testing, especially those involving intentional dosing of test participants with pesticides, on ethical grounds.
Currently, EPA considers third-party human studies on a case-by-case basis, applying statutory requirements, the Common Rule, and, according to the agency "high ethical standards as a guide. In its consideration and review of human studies submitted to the Agency, EPA generally accepts "scientifically valid studies unless there is clear evidence that the conduct of those studies was fundamentally unethical (e.g., the studies were intended to seriously harm participants or failed to obtain informed consent), or was significantly deficient relative to the ethical standards prevailing at the time the study was conducted.
In January 8, 2003 remarks to the Committee on the Use of Third Party Toxicity Research with Human Research Participants, Vera Hassner Sharav, the president of the Alliance for Human Research Protection (AHRP), testified that, "Pesticide experiments in human beings are morally unconscionable and scientifically dubious-they fail to meet fundamental standards of permissible research-as they offer no potential therapeutic benefit to the subjects or society." EPA received comments until May 8, 2005 on its human testing proposal, but it will receive public comments (although it is not required to consider them) after the due date. See EPA's website for EPA's background and to submit comments.
See the Nuremberg code and the Declaration of Helsinki.
Updated: Thursday, Apr. 28, 2005 - 8:02 AM
By DANIEL YEE
Associated Press Writer
ATLANTA (AP) - After years of promoting the chemical DEET as the best defense against West Nile-bearing mosquitoes, the government for the first time is recommending the use of two other insect repellents. Repellents containing the chemical picaridin or the oil of lemon eucalyptus offer "long-lasting protection against mosquito bites," the Centers for Disease Control and Prevention said, adding that repellents with DEET remain on the agency's recommendation list.
"Since West Nile virus is present across the entire country at this point and it's here to stay, we constantly need to be vigilant," said Dr. Lyle Petersen, director of the CDC's division of vector-borne infectious diseases. "It gives consumers a better option to protect themselves."
Both products have been available elsewhere in the world, including Europe and Australia, since the 1980s. Repellent makers have been eager to introduce them to U.S. markets but it was hard to compete with DEET, the only chemical touted as effective by local, state and federal health officials. Federal officials maintained for years that non-DEET repellents were not likely to offer the same degree of protection from mosquito bites. DEET has been the go-to chemical for health officials trying to control the spread of the West Nile virus in the United States.
However, recent studies prompted CDC officials to broaden the recommendations. The CDC says picaridin is "often comparable with DEET products of similar concentration" and oil of lemon eucalyptus provides protection time "similar to low-concentration DEET products in two recent studies."
Consumers tend to like picaridin repellents because they are more pleasant to the skin and don't have the odor that DEET repellents have. And oil of lemon eucalyptus is a natural ingredient, which appeals to those who don't like the thought of putting chemicals on their skin, said Angela Proctor, a product manager for the Cutter line of insect repellents by Spectrum Brands. Nationwide, only about 40 percent of people use insect repellents. In Pacific coast states such as California _ the state with the highest number of cases (771 cases, 23 deaths) last year _ only 23 percent use insect repellent, said Emily Zielinski-Gutierrez of the CDC.
"That's a lot of people who are going out there unprotected," she said. Users complained of DEET's odor or said it feels unpleasant on the skin. DEET repellents also have reportedly damaged plastics and fake fingernails. Other people have speculated it could cause brain damage, although the Environmental Protection Agency said the chemical won't cause harm if used properly.
"There's a certain segment of the population that no matter how safe you tell them DEET is, ... there's a hesitancy to use DEET," said Richard Falco, a Fordham University medical entomologist. "You can do so much to tell people what to use but if they're not using it you have to go to something else. I think this will have a positive impact on public health." DEET was developed by the U.S. Department of Agriculture in 1946 and has been registered with the Environmental Protection Agency as an approved active ingredient since 1957.
Various levels of DEET appear in the popular Off! lines by S.C. Johnson & Son Inc., including Deep Woods and Skintastic. Other brands such as Repel and BugOff! have lately launched products without DEET.
Spectrum Brands introduced a picaridin-based repellent in January _ Cutter Advanced _ and it has been marketing a repellent with oil of lemon eucalyptus since 2002. The products provide four and six hours of protection, respectively, Proctor said.
The CDC said it still will promote other personal protection measures, such as wearing long-sleeved clothing while outside and disposing of containers of water that could be breeding grounds for the flying insects. West Nile virus first arrived in 1999 in New York. Last year there were 2,470 cases and 88 deaths. The highest number of U.S. cases came in 2003, when 9,682 people were infected and 264 died.
Reuters News Service
Houston Chronicle
April 25, 2005, 8:34AM
WASHINGTON - Targeted proteins called monoclonal antibodies may work to treat West Nile virus, a mosquito-borne disease that came to North America in 1999, researchers say.
They found the laboratory-engineered antibodies cured mice infected with the virus, which usually causes only mild fever but which can cause deadly brain inflammation in some patients.
"We could give this antibody to mice as long as five days after infection, when West Nile virus had entered the brain, and it could still cure them," said Dr. Michael Diamond of Washington University in St. Louis, who led the study.
"It also completely protected the mice against death."
West Nile, common in North Africa, parts of Europe and the Middle East, first appeared in New York in 1999 and quickly spread across the continent, affecting Canada and Mexico as well.
It infects birds, horses and people and is spread by mosquitoes. In 2003 it infected a reported 2,300 people and killed 264, according to the U.S. Centers for Disease Control and Prevention. In 2004 it infected 2,470 and killed 88.
"West Nile virus has emerged in the United States as a regular seasonal threat, particularly for people over 50," said Dr. Anthony Fauci, head of the National Institute for Allergy and Infectious Diseases, which funded the study.
"We currently do not have a proven therapy for people with serious West Nile disease, so we will continue to aggressively pursue all promising leads for an effective treatment," Fauci said in a statement.
The researchers decided to develop monoclonal antibody after finding that antibodies taken from the blood of people who recovered from West Nile fever could cure mice infected with West Nile virus.
Writing in the journal Nature Medicine, the team said it made 46 monoclonal antibodies and screened them until they found the most effective ones against West Nile virus.
Rockville, Maryland-based MacroGenics Inc., made a human-like version of the most effective antibody.
They tested it in mice bred to be susceptible to West Nile virus. It protected them from death even if they got severe cases of the disease.
"Our results are the first successful demonstration of a humanized monoclonal antibody as postexposure therapy against a viral disease and suggest that antibody-based therapeutics may have more broad utility than previously appreciated, especially in the treatment of central nervous system infections," they wrote.
(Beyond Pesticides, April 13, 2005) Today, Beyond Pesticides and 19 consumer and environmental groups asked the national headquarters of Home Depot and Lowe's Home Improvement, two of the largest home and garden retailers, to carry a full range of organic, non-toxic lawn care products to protect the health of children, families, pets and the environment and to reconsider the sale of "weed and feed" due to its hazards and environmental pollution. Recent surveys show almost half of all households buying lawn care products are seeking non-toxic alternatives.
"Children are particularly vulnerable to exposure from lawn chemicals," says Dr. Routt Reigart, pediatrician at the Medical University of South Carolina. "Many of the chemicals typically used on lawns present acute and chronic risks to children's health."
The groups, that span across the country, also announce the release of an online Declaration on the Use of Toxic Lawn Pesticides and formation of the National Coalition for Pesticide-Free Lawns, a growing popular movement of consumer and environmental groups, coming together to educate the public, retailers, landscapers and policy makers about the hazards of lawn chemicals and the viability of safe alternatives. Fourteen of 30 commonly used lawn pesticides are 'probable' or 'possible' carcinogens with studies linked to cancer.
A national press conference call, for accredited press only, will kick off the campaign today at 1:00pm eastern daylight time. Contact Beyond Pesticides for the phone number and passcode. Speakers include:
Routt Reigart, M.D., Pediatrician, Medical University of South Carolina
Warren Porter, Ph.D., Environmental Toxicology, Univ. of Wisconsin
Steve Sheffield, Ph.D., Wildlife Toxicology, Virginia Tech (VPI&SU)
Steven Zien, Landscaper, Owner, Living Resources Company
Jay Feldman, executive director, Beyond Pesticides
Out of 213 million pounds of non-agricultural pesticide use in the U.S., more than 90 million pounds are used on private lawns and gardens per year. Some ten percent comes from "weed and feed" products alone, which result in runoff and contaminated drinking water sources. Surveys show 40 million homeowners are buying or looking to buy non-toxic, natural alternatives. Other surveys show that with a little education on the hazards of lawn chemicals even more homeowners would consider buying natural alternatives, presuming they are conveniently available.
"Scientific findings show that the lawn chemical mixtures are linked to neurological, endocrine, immune, and abortion effects. The greatest effects appear to be happening at miniscule exposure amounts," says Warren Porter, Ph.D., environmental toxicologist at the University of Wisconsin, Madison.
"The U.S. Environmental Protection Agency does not evaluate low level exposures like the ones people receive from these lawn products and it doesn't evaluate the actual product mixtures found on store shelves," says Jay Feldman executive director at Beyond Pesticides.
"Twenty-eight of 30 commonly used lawn pesticides are toxic to birds, aquatic organisms like fish or important beneficial insects such as bumble bees, which are critical pollinators of plants and flowers," says Caroline Kennedy, Director of Conservation Initiatives for Defenders of Wildlife. "Keeping a yard with non-toxic alternatives is far easier than the lawn pesticide companies would have you believe, and it's the best way we can go easy on neighborhood wildlife."
The group's request to the retailers, Home Depot and Lowe's, follows on the heels of a new million-dollar public relations marketing campaign by the lawn chemical industry that public interest groups say mislead consumers and landscapers on the hazards of pesticides and on the aesthetic and economic viability of creating green lawns and landscapes without the use of toxic lawn pesticides.
The chemical industry's efforts are largely in response to recent bans on aesthetic uses of pesticides in Canada where seventy municipalities, including Toronto, Quebec, and Halifax, have banned or severely restricted lawn pesticide use. Most states in the U.S. have laws that prevent localities from making such reforms, but in at least seven states legislation is pending that would overturn those laws and open the way for greater protections from lawn chemicals as in Canada.
"We believe in the democratic right of local jurisdictions to protect the health and welfare of their residents," says Shawnee Hoover. "Especially where the community has determined that state laws are insufficiently protective. The fact is healthy, non-toxic lawns and landscapes are realistically achievable, there's just no need to be exposing our kids to carcinogens.
To sign the Declaration and read the background materials, visit http://www.pesticidefreelawns.org.
(Beyond Pesticides, April 11, 2005) In a defensively worded statement on April 8, 2005, Stephen Johnson, Acting Administrator for the U.S. Environmental Protection Agency (EPA) announced the end of the Children's Environmental Exposure Research Study (CHEERS) in which parents were paid to use pesticides in the rooms occupied by their infant children under age three.
Mr. Johnson did not admit any ethical problems with the study but concluded without explanation that the study could not "go forward… in an atmosphere absent of gross misrepresentation and controversy." U.S. Senators Barbara Boxer (D-CA) and Bill Nelson (D-FL) had previously announced that they would hold Johnson's confirmation as EPA Administrator unless he cancelled CHEERS.
While CHEERS will not go forward with EPA funding, the exact same study can proceed with private sponsors, according to Public Employees for Environmental Responsibility (PEER). In fact, the American Chemistry Council, which represents 135 companies including pesticide manufacturers, had already pledged $2 million toward the study's $9 million overall cost.
In February, EPA published a draft policy that opens the door for accepting any experiments conducted by pesticide companies and chemical manufacturers using human subjects without establishing safeguards to ensure that the studies are conducted ethically and without harm to the subjects. Under this policy, EPA indefinitely delays ethical rules and, instead, relies on its political appointees to flag immoral or unsafe practices on a "case-by-case" basis.
"The reason Stephen Johnson clung so stubbornly to this creepy CHEERS effort is that it served as the beacon to industry that EPA would welcome similar experiments," stated PEER Executive Director Jeff Ruch, noting that the pesticide industry wants to use human testing to trump animal studies so as to justify relaxed exposure limits. "Stephen Johnson has become the pesticide industry's 'go-to-guy' at EPA."
In an August 2003 letter to EPA on human testing with pesticides, Beyond Pesticides said the following:
"The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research points out that three basic ethical principles need to be kept in mind when considering using humans as test subjects: respect for persons, beneficence, and justice. Human-based research in order to alter pesticide tolerance levels rmandated by EPA [or generate data to support pesticide product label application rates], and subsequently increase profits for the pesticide companies sponsoring the studies does not qualify as an ethical endeavor. This position is strengthened by the fact that EPA does not generally review efficacy data on pesticides, many of which are not necessary or cost-effective in achieving pest management goals. Since EPA, as a matter of policy, allows the marketplace to define product benefit, the agency has no way of knowing whether pesticide products achieve anything other than sales for the registrants. Ethical scientific studies are those whose results are meant for the betterment of society and the test subjects. In her January 8, 2003 remarks to the Committee on the Use of Third Party Toxicity Research with Human Research Participants, Vera Hassner Sharav, the president of the Alliance for Human Research Protection (AHRP), testified that 'pesticide experiments in human beings are morally unconscionable and scientifically dubious-they fail to meet fundamental standards of permissible research-as they offer no potential therapeutic benefit to the subjects or society.'"
Under the overall human dosing policy advocated by Mr. Johnson, EPA will have no protections for –
· Infants, neonates, pregnant women, and prisoners. By contrast, all medical and drug testing overseen by the Department of Health and Human Services has such safeguards; and
· Ensuring that companies have obtained informed consent or have not paid undue inducements.
As evidenced by EPA's support for CHEERS, the agency lacks any independent safety or ethical review mechanism. After the study had drawn controversy, EPA published on November 23, 2004 a Federal Register notice (69 FR 68143-68144) looking for experts in "ethical standards of research protocols and bioethics" because the agency lacked expertise in those areas. The agency then followed with the "Invitation for Comments on the 'ShortList' Candidates for Children's Environmental Exposure Research Study (CHEERS) Review Panel of the EPA Science Advisory Board (SAB)" which included 29 candidates.
To mask its lack of standards, during his confirmation hearing, Mr. Johnson claimed that the Centers for Disease Control had approved CHEERS. But, according to a January 18, 2005 letter from EPA to Representative Bart Gordon (D-TN), CDC had not reviewed it.
"EPA should adopt the basic safeguards required by common decency before they start using human dosing experiments," Mr. Ruch added. "Canceling CHEERS does not end the argument about the need for ethical standards in human testing; it merely opens another round in that debate."
Source: Environmental Media Services
(Beyond Pesticides, April 5, 2005) The study, The impact of insecticides and herbicides on the biodiversity and productivity of aquatic communities, confirmed that four common pesticides, Sevin® (carbaryl), malathion, RoundUp® (glyphosate), and 2,4-D are harmful to aquatic populations. In particular RoundUp® proved to be highly toxic to amphibians, decreasing their populations by nearly 70%.
Professor Rick Relyea, of the University of Pittsburgh, conducted the study, which is published the April 2005 issue of Ecological Applications. His findings are important in understanding the comprehensive impact that these chemicals have in real world scenario. Dr. Relyea studied the impact of typical dosages on ecologically relevant aquatic species and found that Sevin® reduced species richness (a measure of population size and interactions) by 15%, malathion by 30%, RoundUp® by 22%, and 2,4-D had no impact on species richness.
When looking at the impacts of these chemicals individually, Dr. Relyea found that RoundUp® was highly toxic to amphibians. These findings confirm other studies on amphibians and reproductive effects. However, in this study death occurred completely eliminating two species of tadpoles and a 70% decrease in the entire tadpole population.
According to The University of Pittsburgh Medical Center, Dr. Relyea initially wanted to see whether the Roundup® would have an indirect effect on the frogs by killing their food source, algae. However, he found that since it killed the frogs, the algae populations increased with no predators available to control it.
The most lethal ingredient in RoundUp® is its surfactant rather than its active ingredient (glyphosate) reports The University of Pittsburgh Medical Center, which allows the pesticide to penetrate the outer waxy layer of weeds. The other pesticides in the study have less potent surfactants, explaining RoundUp®'s greater impact in this study
(03-30) 06:42 PST WASHINGTON, (AP) --
Children may be more vulnerable than adults to cancer risks from certain gene-damaging chemicals, the Environmental Protection Agency said Tuesday.
The agency has updated the way it decides which pollutants pose cancer risks, which is intended to lead to better and more accurate reviews of carcinogens that might be regulated.
Under the previous EPA guidelines, last revised in 1986, cancer risks to children were assumed to be no greater than to similarly exposed adults.
In the first such update in nearly 20 years, the EPA said children 2 years old and younger might be 10 times more vulnerable than adults to certain chemicals. Children between the ages of 2 and 16 might be three times more vulnerable to certain chemicals.
The EPA also said it is seeking new ways to gather scientific data on possible carcinogens. It said "the consideration of new, peer-reviewed scientific understanding and data in an assessment can always be consistent with the purposes of these cancer guidelines."
The guidelines were made final after several reviews by the EPA's science advisory board during the past nine years, as the science of assessing cancer risks has evolved.
"The agency's new cancer guidelines represent an opportunity to bring our best understanding of how chemicals might lead to cancer, and provide our best information for regulatory decision-making," said William Farland, the EPA's chief scientist on the issue.
Environmentalists praised some aspects of the guidelines, but criticized others.
Jennifer Sass, a senior scientist for the Natural Resources Defense Council, an environmental group, praised the EPA for seeking new ways of getting scientific data and methods and acknowledging that exposures to pollutants early in life can be especially damaging.
But she said that the Bush administration added language that "basically provides a lot of opportunity for the chemical industry to hold up or stymie chemical reviews." She said the EPA would be asking more "expert elicitation" and "data quality" to justify letting outside parties "push EPA" by insisting on outside opinions.
Farland said, however, that EPA would maintain the integrity of its process and the agency "has a long history of using peer review as an important part of our process."
A study of common household dust released this week found pesticides and other chemicals in samples from 70 homes across the United States. Released by Clean Production Action on March 22, Sick of Dust: Chemicals in Common Products - A Needless Health Risk in Our Homes documents a wide range of chemicals used in common products such as computers, cosmetics and upholstery as well as household and agricultural pesticides in the dust samples.
"We have a right to safety in our own homes," said Angela Grattaroti, a participant in the Sick of Dust study who is a mother and co-chair of a parent advisory council for special education in Leominster, Massachusetts. "It is inexcusable to subject our children to harms that can be avoided."
Every dust sample contained measurable concentrations of five pesticides: cis-permethrin, trans-permethrin, piperonyl butoxide, pentachorophenol (PCP) and 4,4'-DDT. Six more pesticides were found in some of the samples, including: alpha- and gamma-chlordane, chlorpyrifos, deildrin, methoxychlor and propoxur. Researchers tested samples for a total of 14 pesticides in the study.
Permethrin products are widely used in U.S. homes, yards and gardens. They are also used to kill insects in agriculture (especially in corn, wheat and alfalfa production), forestry, and public health programs, including use for head lice control. Because of the widespread use of these products, the Food and Drug Administration (FDA) routinely finds permethrin residues on food. In 2001, it was among the top 10 most commonly detected pesticides in FDA food samples. Like all synthetic pyrethroids, permethrin products kill insects by strongly exciting their nervous systems. Permethrin is a possible carcinogen and also affects both male and female reproductive systems and the immune system. Piperonyl butoxide, which is used in formulations of permethrin, increases the potency of permethrin and related pyrethroids and is also a possible carcinogen.
Most exposure to pentacholorophenol (PCP) in the U.S. comes from its past use on treated wood and soil. From 1987 to 1993 EPA recorded releases of PCP to land and water totaling nearly 100,000 pounds. PCP use has been restricted since 1984, but it is still used as a preservative on wooden utility poles and railroad ties. PCP is a known neurotoxin and a suspected endocrine disruptor, and is classified as a possible human carcinogen.
Although DDT was banned from use in the United States in 1972, a recent body burden study by the Centers for Disease Control and Prevention (CDC) found DDT residues in the blood of 99% of those sampled. DDT is classified as a probable human carcinogen, and has been linked to developmental and reproductive disorders, premature births and reduced lactation in nursing mothers.
Five additional classes of chemicals were found in the dust:
Alkylphenols are found in laundry detergents, textiles, hair-coloring, paints and all-purpose cleaners. These chemicals are widely recognized to mimic natural estrogen hormones leading to altered sexual development in some organisms.
Organotin compounds are found in PVC (polyvinyl chloride) water pipes, PVC food packing materials, glass coatings, polyurethane foams and many other consumer products. These chemicals are very poisonous even in small amounts. They can disrupt the hormone, reproductive and immune systems. Animal studies show that exposure early in life can also have long-term effects on brain development.
Perfluorinated organics are used to make Teflon, Goretex and other oil-, water- and stain-resistant materials for nonstick frying pans, utensils, stove hoods, stain-proof carpets, furniture and clothes. These chemicals have been shown to damage organ function and sexual development in lab animals, and are potentially carcinogenic.
Phthalates are used primarily in vinyl (PVC) products such as shower curtains, raincoats, toys, furniture and flooring. They are also used in paint, pesticides and personal care products (perfume, nail polish, hairspray). These chemicals disrupt reproductive systems in animal studies, particularly in male offspring and can contribute to male infertility. They have been linked to asthma and respiratory problems in children.
Polybrominated dephenyl ethers (Brominated Flame Retardants) are applied to textiles or incorporated into plastics, foams and electrical goods to prevent or slow the spread of fire. These chemicals build up in the body and persist for long periods of time in the environment. Studies show they damage the development of the nervous and behavioral systems in young animals. American women have the highest levels of these chemicals tested for in breast milk.
Sick of Dust authors call for an aggressive program of regulatory reform, corporate responsibility and consumer action. They stress the need for national level policy reforms and highlight state governments that are taking action in the absence of federal leadership. Legislation to phase out dangerous chemicals has been passed or is moving forward in Arkansas, California, Colorado, Hawaii, Illinois, Maine, Massachusetts, Michigan, Minnesota, New York, Oregon and Washington.
In addition to Clean Production Action, the following groups helped coordinate research for the report: Alliance for Healthy Tomorrow, Center for Environmental Health, Citizens Environmental Coalition, Ecology Center, Environmental Health Strategy Center, Oregon Environmental Council, Silicon Valley Toxics Coalition and the Washington Toxics Coalition.
Sources: Press Release, Hazardous Chemicals found in Household Dust Across U.S., New Report Says, March 22, 2005, Safer Products Project, Sick of Dust: Chemicals in Common Products - A Needless Health Risk In Our Homes, March 2005, Pat Costner, Beverly Thorpe and Alexandra McPherson.
Contact: Clean Production Action, 716-805-1056, info@saferproducts.org. For the full report visit www.safer-products.org.This study tested the effects of pyrethroids alone as well as in combination with PBO, a common ingredient to enhance pesticidal potency. Permethrin had a 20% impact on ATPase activity of leukocyte membranes (immune cells,) but a lesser impact on synaptosomes (neurologic cells.) PBO alone inhibited both nerve and immune cells by10-15%. Although, Esbiol and cyfluthrin did not affect either cells when tested alone, in combination with PBO they inhibited activity up to 40%. The study also concluded that the immune cells were more susceptible to inhibition than the nerve cells.
This data confirms the findings of other research on the impact of synthetic pyrethroids, which includes endocrine disruption and carcinogenic effects. It also sheds more light on the impact of synergistic chemical interactions. For instance, in this case when present alone some pyrethroids had virtually no impact on the cells function, however when in combination with PBO a synergistic interaction took place allowing inhibition of cell activity of up to 40%.
Dr. Grosman¿s study confirms pyrethroids can impact the nerve and immune system on the most basic level. This study shows that pyrethroids alone and in synergistic interactions inhibit the enzyme ATPase which allows basic cell processes to take place.
Pyrethroids are commonly used for mosquito control and are found in household insect killers.
By JOAN LOWY Scripps Howard News Service
January 17, 2005
Fearing that a Canadian movement to ban the use of pesticides on lawns will take root in the United States, the lawn-care industry has thrown down the gauntlet - literally.
"The gloves are off," declares an industry ad running in trade magazines under a picture of masculine-looking leather gardening gloves lying atop a lush green lawn.
"Yes, legislation and regulations have been throwing the green industry some rough punches," the ad says. "And we're about to start fighting back."
The ads are underwritten by Project Evergreen, a trade association formed by pesticide makers, applicators, garden centers and mower manufacturers that plans to launch a national public-relations campaign this spring touting the health and lifestyle benefits of thick, green lawns.
The green industry, as the lawn-products industry calls itself, has reason to worry. Increasing concern about the impact of pesticides and synthetic fertilizers on human health and the environment is fueling a movement to ban or restrict the "cosmetic" or "esthetic" use of artificial chemicals for lawns and gardens.
In Canada, the province of Quebec and nearly 70 cities and towns - including Toronto, Montreal, Vancouver and Halifax - have passed laws banning or restricting the use of pesticides for lawn care.
Some activists are predicting that pesticides will become the next tobacco. "Pesticides are a bit like secondhand smoke - if you can smell your neighbor using them on their property, then you're being exposed, too," said Michel Gaudet, president of the Coalition for Alternatives to Pesticides, in St. Bruno, Quebec.
The picture in the United States is more complicated. Over the last several years, the pesticide industry has successfully lobbied state legislatures to pass what are known as "pre-emption laws." These give states responsibility for pesticide regulation and prevent cities and towns from enacting their own laws. So far, 30 states have adopted pre-emption laws.
"Local communities generally do not have the expertise on issues about pesticides to make responsible decisions," said Allen James, president of RISE (Responsible Industry for a Sound Environment), a pesticide-industry lobbying group. "Decisions are made much more carefully and the train moves much more slowly" at the state level.
At the same time, however, 20 states have adopted laws requiring signs or some sort of public notification when pesticides are applied to lawns. Dozens of communities have also adopted policies barring or restricting the use of pesticides on school property, public ball fields and parks.
Beyond Pesticides, an environmental group in Washington, has responded to Project Evergreen's "gloves are off" ad with a copycat ad that features a pair of feminine-looking gardening gloves decorated with daisies over the headline, "Get a Grip."
"The chemical lawn care industry is worried that the word is getting out on the toxic hazards of lawn pesticides," the ad says. "It is possible to have a green lawn without toxic pesticides."
A team of medical researchers with the Ontario College of Family Physicians, a Canadian professional society for family doctors, released a report last year that analyzed 250 previously published epidemiological studies from around the world on possible adverse effects of pesticides on human health. The report found "consistent positive associations" between popular pesticides used in lawn care and cancers, reproductive problems, neurotoxic effects and other serious illnesses.
Pets and wildlife are at risk, too. Another study, by scientists at Purdue University in Indiana, found that Scottish terriers were four to seven times more likely to develop bladder cancer if they had been exposed to lawn chemicals.
But industry officials say pesticides must pass 120 different tests before they can be marketed in the United States. The Environmental Protection Agency determines how much human exposure to a particular pesticide is safe.
However, roughly half of homeowners admit they don't read or follow label directions when applying pesticides and synthetic fertilizers to lawns, often using significantly more than the recommended amount, lawn-care experts said.
"The unintended failure to follow some small part of the label - a minor misapplication - does not jeopardize human health," James said. "It takes a massive misuse of the product to cause harm."
The manufacture of specialty pesticides - lawn products as well as indoor pest killers - is a $2.5 billion annual industry in the United States, James said.
A recent survey sponsored by Organic Gardening magazine in conjunction with the National Gardening Association estimates that of the 90 million U.S. households with yards, about 5 million are exclusively using organic methods, 31 million are using a combination of organic and chemical methods and 35 million are using primarily chemical methods.
"This confirms what we've suspected for a long time, which is that a significant portion of people are interested in or moving toward organic methods," said Scott Meyer, editor of Organic Gardening. "Not everybody has adopted the full idea of having an organic lifestyle, but a lot of people are saying, 'I know what I don't want.' "
January 5, 2005
Since 1998, Europeans have been working on legislation that will require industry to prove that chemicals being sold and produced in the EU are safe to use or handle. The current system requires governments to prove that a chemical is dangerous. If passed, the legislation will send European chemical manufacturers scrambling for safety and health data on chemicals that have been marketed for years; many experts predict that it will change the industry worldwide. With billions of dollars in trade and investments at stake, U.S. companies are expressing concern. Researchers say that over 99% of the more than 30,000 chemicals currently on the market do not have sufficient safety data that are publicly available.
Clearly, the EU represents a huge swath of the chemical industry, and REACH will have global implications," says Michael Walls, director of science policy with the American Chemistry Council, an industry trade group.
Called REACH -Regulation, Evaluation, and Authorisation of Chemicals-the policy will require registration of all substances that are produced or imported into the EU in quantities greater than 1 ton. The amount of information required for registration will be proportional to the chemical's health risks and production volumes. Companies will also need to seek authorization to sell and produce problematic chemicals, such as carcinogens, mutagens, and teratogens. Toxic chemicals that persist in the environment or that bioaccumulate will also need authorization, which will be granted if risks can be adequately controlled or if there are no alternatives.
The European Parliament and the European Council will have hearings on REACH within the next couple of months. The policy is slated for enactment in 2006, but many familiar with REACH say they don't expect anything to be passed until 2007.
U.S. companies have a lot at stake if REACH becomes law. According to Penelope Naas, director of the Office of EU and Regional Affairs for the U.S. Department of Commerce, EU and U.S. markets are intricately linked. U.S. chemical trade across the Atlantic is worth $600 billion every year, but more importantly, she says, U.S. companies have $2.5 trillion invested in Europe.
REACH defenders say it is good policy
"Once you go through the REACH process, you have chemicals that have a 'blessing', and you create better markets," argues Robert Donkers, the environmental counselor to the EU's delegation to the United States and the person credited as the author of REACH. He predicts that the policy will increase the public's confidence in consumer products that have suffered a series of scandals, including mad cow disease and the discovery of dioxin in chickens.
"Our industry is [also] heavily reliant on imports," says Thomas Jostmann, a director with CEFIC, the European Chemical Industry Council. In fact, with a net surplus in chemical trade to the United States, the EU would seem to have more at stake.
The direct costs of REACH to EU companies are projected at about ¤3.5-4 billion over 11 years, with most costs stemming from safety testing and registration. Annually, this comes to about ¤315 million, or 0.06% of annual chemical sales, according to a study by the European Council.
"This is not a crippling blow to industry," says Frank Ackerman, an environmental economist at Tufts University, whose own study on the costs of REACH confirmed these numbers.
European officials said that REACH could both benefit and hamper smaller companies. Because REACH requires businesses to generate safety information for a specific market, the regulation could open up opportunities to smaller companies that find it profitable to furnish these niche customers with the safety information. And as chemicals are removed from the market for safety reasons, small businesses are more likely to respond with innovative products that are safer for users.
"At least in Europe, the innovation is coming from the small- to mid-size companies," says Robert Foster, a senior science advisor to Notox, a company that tests chemicals for safety.
Lawyers representing multinational companies, some based in the United States, say that the EU's plan may violate World Trade Organization (WTO) agreements. Law firms are now lobbying European officials to weaken REACH and may sue the EU before a WTO panel when the law is finally implemented.
Many of the U.S. concerns were given voice in December at a meeting in Cambridge, Mass., that was attended by top representatives from such major chemical-producing and -consuming companies as Estee Lauder, S.C. Johnson & Son, Dow Corning, Merck, Procter & Gamble, and Lyondell.
Walls says that the direct costs of testing will not be the only way companies will be impacted. One-third of the U.S. chemical industry is foreign-owned, and the United States is a net importer of chemicals from Europe. "If products are removed because of REACH, we will be affected," he pointed out.
The new layers of bureaucracy that would be put in place also cause concern. All the information gathered under REACH will be stored in a central database that can be publicly accessed, and the whole initiative is likely to be handled by a soon-to-be-created EU government agency. Detractors say the process in all probability will be unwieldy and a barrier to trade.
Others are worried about the amount of information that will have to pass up and down the supply chain. Companies formulating chemicals will have to ensure that end users have sufficient safety information. For instance, because they will be exposed to greater quantities, industrial chemical workers will have different exposure scenarios than those only using the compound for household applications. But even different industrial users might have varying exposures. For example, workers spraying a cleaning agent in an auto factory would encounter the chemical as a fine mist and might inhale it, while people using the same chemical in the textile industry would probably encounter the chemical in its liquid state. The scenarios would require different safety information.
This problem became apparent during a government-industry simulation of REACH in four different supply chains, says Andreas Ahrens, a co-founder of the German consulting company Ökopol, the Institute for Environmental Strategies. The simulation showed that for product formulators to prepare proper risk assessment documents, a great need exists to determine how consumers use a product and what terms and language they can understand. "Users will buy based upon the information available," says Ahrens. "And companies will have markets based upon whether they choose to develop that information to service certain markets."
Ahrens worries that some companies may become overburdened by the necessary paperwork, especially small- to medium-size firms with fewer than 250 workers. A representative from the Synthetic Organic Chemical Manufacturers Association (SOCMA), a U.S. industry trade group representing smaller chemical companies, agreed and said that the high costs of REACH may keep new products from ever getting to market.
"It could have a detrimental impact not only on exports but [also] on investments," added Naas.
In an interview with ES&T , European government officials charged that U.S. government agencies have worked closely with business to weaken the impact of REACH, but they did not wish to state this publicly for fear of alienating U.S. officials. Naas dismissed those criticisms at the conference: "The press likes to publicize this as the U.S. attacking the EU."
However, documents gathered by the environmental group Environmental Health Fund under the Freedom of Information Act and released by U.S. Rep. Henry Waxman (D-CA) last spring paint a very different picture. These documents indicate that various agencies within the U.S. government have conspired with chemical companies and chemical trade organizations to derail the scope of REACH. According to the documents, U.S. government lobbying on behalf of industry included a cable in April 2003 from then Secretary of State Colin Powell to diplomatic posts in the EU that provided "talking points" for U.S. government officials to use when speaking with their European counterparts. The arguments were notably similar in language to themes developed by industry at the request of a U.S. trade official, charges Waxman.
For instance, one of the themes developed by industry reads: "REACH will work to stifle innovation and the introduction of new, safer chemicals." In his cable to U.S. diplomats, Powell wrote, "These compliance costs may negatively impact innovation and EU development of new, more effective, and safer chemicals and downstream products."
"The United States has not conducted studies on the health and environmental impacts of REACH," Waxman tells ES&T . "It [simply] began to lobby against REACH on behalf of U.S. industry interests without a full understanding of these impacts." The EU's own analysis of REACH projected a possible savings of ¤50 billion in health-care costs, he says. "My primary concern is that the Bush Administration has allowed special interests to dictate government policy." Industry experts contacted by ES&T declined to respond to Waxman's report.
The most interesting wrinkle in the debate over REACH is now occurring in California. In early 2004, State Assembly member John Laird (D), chair of the assembly environment committee, and former State Sen. Byron Sher (D), chair of the senate environment committee, tasked the University of California, Berkeley, with developing a modern chemical policy for the state. When interviewed by ES&T in November, Michael Wilson, an assistant research scientist in the Center for Occupational and Environmental Health at Berkeley, said the report's recommendations will have many elements in common with REACH. He expected the report to be released sometime in March and said that chemical industry representatives were already talking to state lawmakers about the topic. By December, Wilson said that he was unable to talk further with the media until the report was released.
A senior science advisor to the California State Legislature said that certain legislators are exploring changes to state chemical policy because federal regulations are broken. In the past decade, California has been hit with a number of costly chemical scandals, including the discovery of perchlorate in foods and the gasoline additive methyl- tert -butyl ether (MTBE) in drinking water.
"California needs to go beyond this inadequate federal oversight," said the science advisor, asking to remain anonymous. The advisor added that chemical trade groups are "nervous about what we're up to" but that many companies would like to see better chemical policy along the lines of REACH, so that they can quickly remove harmful chemicals from the market and protect themselves from lawsuits.
Geert Dancet, the European Commission official in charge of REACH legislation, was more direct in his assessment: "Companies in America are probably worried because if Americans see that Europe has these protections, they might want them as well. -PAUL D. THACKER
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