Some of the first eerie signs of a potential health catastrophe came as bizarre deformities in water animals, often in their sexual organs.

Frogs, salamanders and other amphibians began to sprout extra legs. In heavily polluted Lake Apopka, one of the largest lakes in Florida, male alligators developed stunted genitals.

In the Potomac watershed near Washington, male smallmouth bass have rapidly transformed into “intersex fish” that display female characteristics. This was discovered only in 2003, but the latest survey found that more than 80 percent of the male smallmouth bass in the Potomac are producing eggs.

Now scientists are connecting the dots with evidence of increasing abnormalities among humans, particularly large increases in numbers of genital deformities among newborn boys. For example, up to 7 percent of boys are now born with undescended testicles, although this often self-corrects over time. And up to 1 percent of boys in the United States are now born with hypospadias, in which the urethra exits the penis improperly, such as at the base rather than the tip.

Apprehension is growing among many scientists that the cause of all this may be a class of chemicals called endocrine disruptors. They are very widely used in agriculture, industry and consumer products. Some also enter the water supply when estrogens in human urine — compounded when a woman is on the pill — pass through sewage systems and then through water treatment plants.

These endocrine disruptors have complex effects on the human body, particularly during fetal development of males.

“A lot of these compounds act as weak estrogen, so that’s why developing males — whether smallmouth bass or humans — tend to be more sensitive,” said Robert Lawrence, a professor of environmental health sciences at the Johns Hopkins Bloomberg School of Public Health. “It’s scary, very scary.”

The scientific case is still far from proven, as chemical companies emphasize, and the uncertainties for humans are vast. But there is accumulating evidence that male sperm count is dropping and that genital abnormalities in newborn boys are increasing. Some studies show correlations between these abnormalities and mothers who have greater exposure to these chemicals during pregnancy, through everything from hair spray to the water they drink.

Endocrine disruptors also affect females. It is now well established that DES, a synthetic estrogen given to many pregnant women from the 1930s to the 1970s to prevent miscarriages, caused abnormalities in the children. They seemed fine at birth, but girls born to those women have been more likely to develop misshaped sexual organs and cancer.

There is also some evidence from both humans and monkeys that endometriosis, a gynecological disorder, is linked to exposure to endocrine disruptors. Researchers also suspect that the disruptors can cause early puberty in girls.

A rush of new research has also tied endocrine disruptors to obesity, insulin resistance and diabetes, in both animals and humans. For example, mice exposed in utero even to low doses of endocrine disruptors appear normal at first but develop excess abdominal body fat as adults.

Among some scientists, there is real apprehension at the new findings — nothing is more terrifying than reading The Journal of Pediatric Urology — but there hasn’t been much public notice or government action.

This month, the Endocrine Society, an organization of scientists specializing in this field, issued a landmark 50-page statement. It should be a wake-up call.

“We present the evidence that endocrine disruptors have effects on male and female reproduction, breast development and cancer, prostate cancer, neuroendocrinology, thyroid, metabolism and obesity, and cardiovascular endocrinology,” the society declared.

“The rise in the incidence in obesity,” it added, “matches the rise in the use and distribution of industrial chemicals that may be playing a role in generation of obesity.”

The Environmental Protection Agency is moving toward screening endocrine disrupting chemicals, but at a glacial pace. For now, these chemicals continue to be widely used in agricultural pesticides and industrial compounds. Everybody is exposed.

“We should be concerned,” said Dr. Ted Schettler of the Science and Environmental Health Network. “This can influence brain development, sperm counts or susceptibility to cancer, even where the animal at birth seems perfectly normal.”

The most notorious example of water pollution occurred in 1969, when the Cuyahoga River in Ohio caught fire and helped shock America into adopting the Clean Water Act. Since then, complacency has taken hold.

Those deformed frogs and intersex fish — not to mention the growing number of deformities in newborn boys — should jolt us once again.

Parents and children say they like the scrunchy, seemingly kid-safe surface of shredded tires used on playgrounds and sports fields. But is it safe?

The material is used in 11 playgrounds in the state park system, Oklahoma State University’s football field and the Chitwood Park playground in Edmond.

"This is my son’s favorite park to come to,” Kathryn Rosenbach said of Chitwood Park, off Second Street near Kelly Avenue.

Confetti-like shredded rubber cushions the play area beneath the rocket-ship playground equipment.

"I like it,” said Michael Rosenbach, 8.

The U.S. Environmental Protection Agency for years has endorsed recycled tires for use on roads and playgrounds. But internal EPA documents released recently to The Associated Press express concern that recycled rubber on athletic fields and playgrounds may contain enough lead to be hazardous with repeated exposure. The document urged a broader study.

New York and New Jersey have closed six synthetic turf sports fields and are ripping out some artificial turf fields amid concerns of high lead levels.

Older fields containing earlier products seem to contain the most lead, said EPA spokesman Dale Kemery.

As a mom and day care worker, Sharon Shepherd said she appreciates the difference between wood chip, rock and shredded tire playground surfaces.

"This is best by far,” she said. "With chips, they get poked in the eye; they get it stuck up the nose and ears.”

She pointed to a little boy climbing on the rocket ship in Chitwood Park and said he fell on the rocks at another playground.

"It busted his lip. He had to get stitches,” she said. "So this stuff is safer.”

Tests show the body can absorb lead from artificial turf fibers and turf-field dust if they are swallowed, the New Jersey Health Department said.

Children under 6 are at most risk from lead, which can cause irreversible brain damage, said Cheryl Barr, coordinator of the state Health Department’s Oklahoma Childhood Lead Poisoning Prevention Program.

After finding artificial turf samples with lead levels eight to 10 times above levels considered safe by the state, the New Jersey health department asked the federal government to investigate the artificial turf used on sports fields, playgrounds and around homes.

"(Opponents) have chosen to use fearmongering to make allegations against the product that just are not factually correct,” said Dan Zielinski, spokesman for the Rubber Manufacturers Association.

The association has a report posted at www.rma.org that links to its studies.The New York Department of Environmental Conservation reported studies have shown very low concentrations of chemicals. A consultant hired by New York reviewed literature on synthetic turf chemicals and determined that exposure to chemicals in the product is likely small and unlikely to risk people’s health.

"There’s ample scientific data showing that crumb rubber products do not pose a human health hazard,” Zielinski said.

The Synthetic Turf Council hired two scientists to look at New Jersey’s 2008 study.

"There is no scientific evidence of a health risk for children or adults based on recent test results and current knowledge of the chemical structure of aged synthetic turf products,” said the scientists, Dr. David Black of Aegis Science Corp. and Dr. Davis Lee of InnovaNet LLC, in a joint statement.

Chitwood Park is the only Edmond park using the tire product, said spokeswoman Claudia Deakins. The city launched a $100,000 renovation that included the tall rocket ship that needed heavy cushioning to soften falls. Deakins said the surface — introduced at the park in January — met federal guidelines for safety for children, including those with disabilities.

"Should there be any problem with it at all, we wouldn’t use it,” Deakins said.

Earl London, Edmond’s assistant parks and recreation director, said the product has been approved by national and state park recreation groups. Though initial costs are higher than sand, wood or gravel, it’s softer and doesn’t require as much labor and replacement, he said.

Those characteristics have made the recycled tire product the trendiest product among parks and recreation managers across the nation, said Vaughn Sullivan, Midwest City’s community service director.

"That is what most folks are switching to, the recycled rubber tires. And there are hundreds of vendors that recycle that rubber and sell it across the summer. So I would seriously doubt that all of it is contaminated with lead,” Sullivan said.

"As safety conscious as the parks and recreation industry is, I seriously doubt that all the vendors would have that issue.”

Midwest City, Moore, Mustang and Norman do not use the shredded tire product at playgrounds.

Playgrounds in Oklahoma City parks use engineered wood fiber designed to reduce splintering, said Oklahoma City parks and recreation spokeswoman Jennifer McClintock. The city determined that wood is better because it decomposes and is cheaper than the crumb product.

Of the roughly 150 playgrounds in the state park system, 11 of the newer ones have the recycled tire surface, said Hardy Watkins,executive director of the Oklahoma Tourism and Recreation Department.

Watkins said the department has been watching for the EPA study results and is prepared to change those surfaces to wood chips if needed.

"Safety is our No. 1 concern,” Watkins said. "So we would make the change immediately if there were indeed an issue with that material.”

*Appeals court says lower court ruling to stand

*Food safety advocates call ruling a major victory (Adds Monsanto comments)

By Gina Keating

LOS ANGELES, June 24 (Reuters) - A U.S. appeals court on Wednesday left in place an injunction barring Monsanto Co (MON.N) from selling its Roundup Ready alfalfa seed until the government completes an environmental impact study on how the genetically modified product could affect neighboring crops.

The Ninth Circuit Court of Appeals rejected the company's request for a rehearing of its appeal and said it would accept no more petitions for rehearing in the three-year-old case.

Monsanto's only remaining avenue appears to be U.S. Supreme Court review.

Monsanto spokesman Garrett Kasper said the company was "disappointed" by the appeals court ruling "but we are considering our legal options and one of them could include a request for review by the Supreme Court."

Roundup Ready alfalfa is not a "core crop platform" for Monsanto, and the outcome of this case will have little or no impact on the company's May 13 forecast that its U.S. gross profit from sales of seeds and traits will double by 2013, spokesman Lee Quarles said.

George Kimbrell, staff attorney for the Center for Food Safety, called the ruling "a major victory for consumers, for farmers and for the public as far as protecting their rights to ...to sow the crop of their choice and...eat the food of their choice."

Kimbrell, whose group is a plaintiff in the case, predicted that Monsanto's chances of getting Supreme Court review of the case were "slim to none and slim just left town."

Environmental groups and conventional seed companies, led by Geertson Seed Farms, sued the U.S. Department of Agriculture in February 2006 to force it to rescind its 2005 approval of the Monsanto seed until it does a full environmental study.

Monsanto intervened on the government's side in the suit.

The plaintiffs claimed cross pollination of genetically modified crops could contaminate conventional alfalfa fields and overuse of the herbicide Roundup, which the seeds were bred to resist, could foul soil and groundwater or give rise to Roundup-resistant "super weeds."

The trial judge, U.S. District Court Judge Charles Breyer, ruled in 2007 that an agency study had failed to address those concerns. The Ninth Circuit affirmed that ruling twice.

The USDA did not join Monsanto in its petition for rehearing. The USDA has agreed to conduct the environmental impact study, but has not indicated when the study would be completed, Kimbrell said.

Kasper said the company was hoping that USDA would open the public comment period on a preliminary draft of the environmental impact study this summer.

A USDA spokeswoman did not respond to requests for comment.

Genetically modified crops, particularly corn and soybeans that are resistant to herbicide, are popular with U.S. farmers. St. Louis-based Monsanto is the leading developer of such crops.

About two dozen countries allow the cultivation of biotech crops, but much of Europe, Japan, and most of Africa remain opposed to genetically altered crops.

The case is Geertson Seed Farms et al v. Mike Johanns as Secretary of the USDA, Case No. 07-16458, U.S. Court of Appeals for the Ninth Circuit. (Reporting by Gina Keating; Editing by Steve Orlofsky and Carol Bishopric)

A small biotechnology company facing possible bankruptcy and liquidation has been awarded a $35 million federal contract to develop a faster way to make vaccines for pandemic influenza.

The award of the contract to the Protein Sciences Corporation of Meriden, Conn., was announced on Tuesday by the Department of Health and Human Services. But only a day earlier, creditors filed a petition in federal bankruptcy court in Wilmington, Del., seeking to force Protein Sciences into bankruptcy and liquidation, saying they were owed $11.7 million.

Almost all of that money is owed to Emergent BioSolutions, a vaccine company in Rockville, Md., that lent Protein Sciences $10 million last year in advance of the pending acquisition of virtually all the assets of Protein Sciences by Emergent. The acquisition deal fell apart, and Emergent sued Protein Sciences and its top executives, accusing them of fraud and breach of agreements.

The series of events raises questions about whether the government is entrusting part of the nation’s influenza defense to a financially shaky or untrustworthy company. Conversely, the award of the contract could put Emergent into an uncomfortable light for trying to force into bankruptcy a company with promising vaccine technology.

Robin Robinson, director of the branch of Health and Human Services that will administer the contract, said the government had spent months doing “two very thorough financial audits” of Protein Sciences. “It was determined that they were healthy enough to go forward with development of this vaccine,” he said.

Health authorities are scrambling to come up with enough vaccine to protect the world’s population against the recently declared pandemic of swine flu, which has killed more than 230 people worldwide and sickened more than 52,000. They are worried that the death toll from the strain might rise sharply this winter.

“I can’t imagine what legitimate purpose can be served by trying to close the company,” Daniel D. Adams, the chief executive of Protein Sciences, said in an interview on Tuesday. Mr. Adams said that Emergent’s suit was without merit and that its actions were making it difficult for Protein Sciences to attract new investors.

But Daniel J. Abdun-Nabi, president and chief operating officer of Emergent, said that bankruptcy “doesn’t destroy the product, and it doesn’t destroy the technology.” It might result in the technology’s being sold to a stronger company, like his own or others, he said. Emergent, which makes the anthrax vaccine used by the armed forces, says it has been more than patient in giving Protein Sciences a chance to pay back the loan.

Protein Sciences is one of several small companies trying to make influenza vaccines by methods that are faster than growing them in chicken eggs, the technique now generally used.

Instead of growing whole viruses, Protein Sciences produces just a protein from the virus and it does so in genetically modified insect cells.

The company, which is privately held, has already applied to the Food and Drug Administration for approval of a seasonal flu vaccine. And last week, Mr. Adams said, the company made its first 100,000 doses of a vaccine against the new swine flu.

The federal contract will help Protein Sciences develop its technology and obtain F.D.A. approval. It can be extended up to five years for a total cost of $147 million.

If the technology is proved safe and effective and is licensed by the F.D.A, the contract calls for Protein Sciences to establish domestic manufacturing capacity, to provide a finished vaccine within 12 weeks of the onset of a pandemic and to produce at least 50 million doses of a pandemic flu vaccine within six months.

Mr. Robinson of Health and Human Services said that for the current pandemic, the Protein Sciences vaccine might be used as a backup to those being supplied by larger companies.

The Pentagon and the defense industry is lobbying the White House to prevent U.S. EPA from tightening a health advisory for a rocket-fuel chemical.

Representatives of the Defense Department, the Navy and aerospace and defense companies have met with the Office of Management and Budget this month to discuss a pending EPA decision on the chemical, perchlorate.

In a document presented to OMB, the groups argue that rushing a decision will have "adverse public health consequences and unintended negative effects on all drinking water regulatory programs, and on voluntary, state and federal cleanup efforts."

Perchlorate contamination of drinking water, which is linked to DOD and contractor activities at rocket test sites, has been documented in at least 35 states and the District of Columbia. The chemical can inhibit the thyroid gland's iodine uptake, interfering with fetal development.

EPA said in January it would not decide on regulating perchlorate in drinking water until after the National Academy of Sciences evaluates the federal health advisory level of 15 parts per billion -- a guideline for state and local regulators. EPA also wants the science panel to address modeling to determine the chemical's effects on infants and young children and the implications of recent biomonitoring studies.

Last year, the Bush administration's EPA said it would not limit perchlorate in water, saying there is no "meaningful opportunity for health risk reduction" through a regulation of national drinking water.

But critics slammed the decision. EPA's inspector general found in January the agency violated its own guidelines regarding perchlorate because it did not consider the cumulative effects of perchlorate and other environmental toxins (Greenwire, Jan. 5).

None of the defense groups could be reached for comment, but they submitted documents suggesting their concerns about press reports of the chemical in milk, fruits and vegetables. "Media-generated 'health scares' based on misconceptions of new studies or unclear understanding of regulatory objectives usually create a false perception of risk and lead to worse dietary choices," they wrote.

EPA's recent proposal to change its risk-assessment process by reversing some Bush-era changes to the Integrated Risk Information System, or IRIS -- a key chemical database -- could also be prompting industry concerns, said Jeff Ruch, executive director of Public Employees for Environmental Responsibility.

EPA will now manage the chemical-assessment process itself; previous interagency consultations on risk were managed by OMB and other agencies, including the Pentagon, and could participate in the risk assessment process earlier.

"The defense industry is the 500-pound pollution gorilla," Ruch said. "Perchlorate is at the top of their concerns because it's become probably the biggest clean water challenge facing the country."

* 6 reports of developmental delays in children - FDA memo

* Reports collected since Depakote's approval in 1983

* Unclear if anti-seizure drug played a role

* Abbott says will work with FDA to evaluate risks (Adds Abbott comment, detail on drug, sales figures)

By Lisa Richwine

WASHINGTON, June 19 (Reuters) - U.S. drug reviewers have recommended additional study of delayed development reported in children of mothers who took Abbott Laboratories' (ABT.N) anti-seizure drug Depakote.

Six cases received since its approval in 1983, including two siblings reported to have autism, "raise concerns," Food and Drug Administration staff wrote in a May 6 memo released on Friday.

Limitations in the reports "make it impossible to definitively conclude" the drug played a role, and genetics or other factors may have contributed, especially in the two sibling cases of autism, the FDA reviewers said.

"Further study is needed to further elucidate causality and degree of risk of fetal exposure to (Depakote) and subsequent developmental delay in children," they added.

Depakote, known generically as divalproex, is approved for treating epilepsy and mania associated with bipolar disorder and for preventing migraines.

The drug already carries a strong "black box" warning that it may cause birth defects. In the six cases of developmental delays, no defects were reported at birth, FDA reviewers said.

Abbott will "continue to participate in discussions with the FDA and its advisers to further evaluate any risks related to anti-epileptic drugs, neurodevelopment and pregnancy," spokeswoman Raquel Powers said.

"For many women, Depakote may be the only effective medicine to control their seizures" and doctors and patients should evaluate the drug's risks versus its benefits, Powers said.

Depakote was once a blockbuster for Abbott but sales dropped sharply after generic competitors became available. First-quarter sales for the drug were $110 million.

The FDA staff memo was released ahead of an advisory panel meeting, scheduled for Tuesday, where outside experts will review the safety of various drugs for children.

Abbott shares were little changes, up 5 cents to $47.71 in late morning trading on the New York Stock Exchange.

The FDA posted the staff memo here. (Reporting by Lisa Richwine; Editing by Brian Moss and Tim Dobbyn)

Federal microbiologists and food safety investigators have descended on the Danville, Va., plant that makes Nestlé's refrigerated cookie dough, trying to crack a scientific mystery surrounding a national outbreak of illness from E. coli 0157, a deadly strain of bacteria, which has been linked to the product.

LEADING scientists and doctors have raised fresh concerns about the safety of a cervical cancer vaccine.

They have accused the manufacturers of Cervarix and another jab, Gardasil, of making misleading claims.

More than 1,300 British girls have reported adverse reactions to Cervarix, ranging from paralysis to convulsions and sight problems.

Hailed as a wonder drug, it is claimed the jab will give 70 per cent protection from the disease to every girl under 18 by 2011.

Earlier this month the Sunday Express revealed the story of Rebecca Ramagge, 13, of Reigate, Surrey, who has been unable to walk for six months because of a joint disorder.

Rebecca’s paediatrician blames her condition on Cervarix.

In Germany, 13 distinguished professors have complained that the jab makers, Glaxo SmithKline and Sanofi, have been guilty of giving “incorrect” information.

Professor Martina Doren, of the Charitie Hospital in Berlin, said: “What concerns us is that the two manufacturers of the vaccine aren’t always using facts. They claim that a lot of high-risk strains of cancer-causing virus are protected against but equally there are others that are not.

“If protection is not more than 20 per cent then that is an awful lot of money to be spending, particularly as the vaccines have quite serious side-effects.

“Assertions that a vaccine reduces the risk of cervical cancer by 70 per cent or even 98 per cent should not be made at this point.”

Professor Doren criticised the fact that the only trials for the vaccines were carried out on women aged between 15 and 26 while the vaccine was being given to 12 and 13 year olds.