(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 Administrato