New Test for Spreading Breast Cancer

FDA Approves First Molecular-Based Lab Test to Detect Metastatic Breast Cancer The U.S. Food and Drug Administration today approved the first molecular-based laboratory test for detecting whether breast cancer has spread (metastasized) to nearby lymph nodes. The GeneSearch BLN Assay detects molecules that are abundant in breast tissue but scarce in a normal lymph node. The presence or absence of breast cancer cells in underarm lymph nodes is a powerful predictor of whether the cancer has spread and is used to help decide appropriate therapy for a woman with metastatic breast cancer. Lymph nodes are part of the system that helps protect the body against infection. The first lymph node that filters fluid from the breast is called the “sentinel node,” because that is where breast cancer cells are likely to spread first. During a lumpectomy or mastectomy to remove a breast tumor, surgeons commonly remove the sentinel node for examination under a microscope. Sometimes the sentinel node is examined immediately and if tumor cells are found, additional lymph nodes are removed. A more extensive microscopic examination, requiring one to two days for results, is almost always performed. If tumor cells are only found with the later microscopic examination, the patient may require a second surgery to remove the remaining lymph nodes. “The GeneSearch BLN Assay offers a new approach to sentinel node testing,” said Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health. “Results of this rapid test are available while patients are on the operating table, providing a way for some women to avoid a second operation.” In a clinical trial, the GeneSearch BLN Assay showed strong agreement with results from extensive microscopic examination of the lymph nodes of 416 patients. The test accurately predicted that breast cancer had spread nearly 88 percent of the time in women with metastasis. Patients without metastasis were identified accurately 94 percent of the time. Most of the women were also studied to compare the BLN Assay with immediate microscopic examination during surgery. The test gave fewer false negative results, but slightly more false positive results. A false negative test result, when the cancer has actually spread, may delay the needed removal of additional lymph nodes. A false positive test, indicating metastasis when there is none, may result in a more extensive surgery and puts the women at risk of unnecessary lymphedema (swelling due to fluid build-up following lymph node removal) and other side effects. The GeneSearch BLN Assay is manufactured by Veridex, a Johnson & Johnson Company, of Warren, N.J.

Death Rate of Hip Fracture Higher than Breast Cancer in Elderly

May 18, 2007 — Older women are at greater risk for death after hip fracture than after breast cancer, according to a presentation at the American Geriatrics Society (AGS) annual meeting held in Seattle, Washington. The investigators suggest that increased awareness of mortality associated with hip fracture is needed to improve preventive measures. "This study should raise the general level of awareness of the impact of hip fracture on the lives of elderly women," coauthor Jane A. Cauley, DrPH, a professor of epidemiology at the University of Pittsburgh in Pennsylvania, told Medscape. "There is already a greater general level of awareness of the public health impact of breast cancer, but, in fact, our study showed that the mortality of breast cancer in this population was less than that of hip fracture. The public health impact on mortality was much greater for hip fracture than for breast cancer, even after adjustment." The authors concluded that older women are at a greater risk for death after hip fracture than after breast cancer diagnosis, and that increased awareness of mortality associated with hip fracture is needed to promote preventive measures. "The implications of this study are that we should aim more studies at the correct treatment of the patient with a hip fracture," S. K. Bulstra, MD, a professor of orthopaedic surgery at the University Medical Center Groiningen in the Netherlands, told Medscape. Dr. Bulstra was not involved with this study but was asked by Medscape to provide independent commentary. "Of course it is important to know whether these patients also had more comorbidity than the breast cancer patients," Dr. Bulstra said. "The reduced weight of the hip fracture group suggests a higher frequency of osteoporosis. It is also important to know if patients came from a home situation or a nursing home and how the mental status was assessed, because indeed there is a connection between survival and mental status." Dr. Bulstra's own research and experience suggest an increased mortality rate for 10 years or more after hip fracture, although the survival rate stabilizes after 2 years. Many patients are no longer able to live at home after hip fracture, which is related to their walking ability both before and after the fracture. Congestive heart failure, renal failure, liver disease, lymphoma, and weight loss each increased the 1-year mortality risk by approximately 2-fold. "Future studies should compare the effect of hip fracture and of breast cancer on quality of life in this population, in terms of functional disability, pain, mobility, and other outcomes," Dr. Cauley concluded.

Treatment at End of Life in Cancer Patients

Laurie Barclay, MD May 3, 2007 — For patients with advanced cancer, aggressive treatment in the last week of life is linked to a worse quality of death and less likelihood of dying in the place of the patient's choice, according to a presentation on May 3 at the American Geriatrics Society (AGS) annual meeting in Seattle, Washington. "We found that the greater the number of aggressive treatments these advanced cancer patients received in their last week of life, the more psychological and physical distress they experienced, as reported by family members or nurses who were with them at that time," presenter and lead author Gabriel K. Silverman, MS, an MD/PhD student at the Department of Social and Decision Sciences, Carnegie Mellon University, and the University of Pittsburgh School of Medicine in Pennsylvania, told Medscape. "Of patients who received no aggressive treatments in the days preceding their death, nearly 90% died in their preferred location, while this was true of only about a third of patients receiving two or more of these treatments. We found the reverse pattern of outcomes associated with duration of hospice use." "This study shows an association between aggressive treatment and psychological and physical distress, but that might be because people who are more distressed ask for more treatment, rather than because the treatment itself is causing distress," Dr. Arnold said. "More research is clearly needed, as is greater use of palliative care doctors at the end of life." Mr. Silverman pointed out that discussions about prognosis, goals of care, and treatment preferences, including the option of hospice care, should occur with more patients and earlier in the course of the disease. His group is now prospectively evaluating whether doctor-patient communication predicts aggressiveness of care at the end of life, and whether these treatments, in turn, affect the bereavement adjustment of close family members. "As a doctor, if I had a patient or family who wanted aggressive, life-sustaining care toward the end of their life, I would view it as a red flag warning of patient or caregiver distress," Dr. Arnold concluded. "Often patients and their families are suffering, sad, or distressed at the end of life, and when dying occurs in medical settings they may hope that aggressive treatment will help the suffering, but often it doesn't." The National Institute of Mental Health, National Cancer Institute, a predoctoral National Institutes of Health training grant in aging research, and the Center for Psycho-Oncology and Palliative Care Research, Dana-Farber Cancer Institute, supported this study. Mr. Silverman and Dr. Arnold report no relevant financial relationships. AGS 2007 Annual Scientific Meeting: Abstract P4. Presented May 3, 2007.

Blood Pressure Meds Reduce Memory Loss in Elderly

May 5, 2007 — Compared with other antihypertensive agents, centrally active angiotensin-converting enzyme inhibitors (ACEIs) are associated with slower rates of cognitive decline over 6 years in elderly people free of dementia at baseline, according to findings from the Cardiovascular Health Study (CHS) presented on May 5 at the annual meeting of the American Geriatrics Society in Seattle, Washington. "ACE inhibitors that cross the blood-brain barrier reduce cognitive decline by 50% compared [with] the decline seen in people on other blood pressure medications," presenter and lead author Kaycee M. Sink, MD, MAS, an assistant professor of internal medicine in gerontology at Wake Forest University School of Medicine in Winston-Salem, North Carolina, told Medscape.

Blood Clots During Travel

The chances of developing deep vein thrombosis double after traveling for four hours or more, the World Health Organization (WHO) said on Friday. Its study estimates that 1 in 6,000 long-haul passengers is at risk. Tall people whose legs are jammed in economy class and the very short whose feet do not touch the ground are particularly vulnerable to potentially dangerous blood clots linked to immobility during travel, the United Nations agency said. The obese, women on birth control pills and those with blood clotting disorders are also more susceptible, as are frequent travelers and those who take very long journeys. "There is an increased risk of venous thromboembolism during travel where the passenger is seated and immobile over four hours, whether in a plane, train, bus or car," said Catherine Le Gales-Camus, WHO assistant director-general for non-communicable disease and mental health. "What causes the risk is immobility," she told a news conference. "The risk is not only true for people flying." About 2 billion people travel by air each year and many more take overland trips where they sit still for prolonged periods. Health experts said the overall prevalence of deep vein thrombosis is relatively low, noting that the 1 in 6,000 ratio includes those with small or asymptomatic clots. Still, it means an average of one person is affected for every 20 long-haul flights carrying 300 passengers. To reduce the chance of developing blood clots, WHO special advisor Shanthi Mendis said travelers should exercise their calf muscles with up-and-down movements of the feet and ankle joints, and leave their seats for a few minutes when possible. Mendis cautioned air passengers against taking sleeping pills or drinking too much alcohol. People should also avoid wearing tight clothing that can constrict circulation, she said.

Patients with Diabetes - Best Way to Follow?

Heartwire 2007. © 2007 Medscape July 3, 2007(Chicago, IL) - A small but clinically relevant change appears to be coming to the management of patients with diabetes mellitus. Hemoglobin A1c (HbA1c) levels, used to assess long-term glycemic control, might soon be replaced with average blood glucose, a change experts say will add clarity for diabetic patients looking to manage their disease. Discussing the expected change here at the American Diabetes Association (ADA) 2007 Scientific Sessions last week, Dr David Nathan (Harvard University Medical School, Boston, MA) said that "patients have a glucose problem, not a hemoglobin problem" and that fasting glucose would be a better measure, as this new value "would help them understand their disease better." Reporting glycohemoglobin results as an A1c-derived average glucose, said Nathan, would have the advantage of reporting chronic glycemia in the same units as the patients' self-monitoring of daily glycemia. Nathan is the lead investigator of the international ADAGE trial, a study performed to confirm the relationship between average glucose and HbA1c levels. To date, only a few studies with relatively infrequent glucose monitoring support a strong mathematical relationship between average glucose and HbA1c, but if a switch is to be made from HbA1c to average glucose levels, an international study is needed to establish the relationship across diabetes type, races, and ethnicities, said Nathan.

Safe Fish and Concerns

EWG’s Fish List What Women Should Know About Mercury In Fish Avoid If Pregnant Shark Swordfish King mackerel Tilefish Tuna steaks Canned tuna Sea bass Gulf Coast Oysters Marlin Halibut Pike Walleye White croaker Largemouth bass Eat No More Than One Serving From This List Per Month Mahi mahi Blue mussel Eastern oyster Cod Pollock Great Lakes salmon Gulf Coast blue crab Channel catfish (wild) Lake whitefish Lowest In Mercury Blue crab (mid-Atlantic) Croaker Fish Sticks Flounder (summer) Haddock Trout (farmed) Salmon (wild Pacific) Shrimp * * Shrimp fishing and farming practices have raised serious environmental concerns. ** Farmed catfish have low mercury levels but may contain PCBs in amounts of concern for pregnant women. Data From The 1970s Show High Concentrations (No Recent Data Available) Porgy Orange Roughy Snapper Lake Trout Bluefish Bonito Rockfish

Agribusiness/Power Subsidies

POWER DRAIN OAKLAND - Some of America's richest and largest farms are paying pennies for the vast amounts of electricity needed to deliver irrigation water to California's arid Central Valley. In 2002 and 2003, agribusinesses in the Central Valley Project (CVP) paid only about one cent per kilowatt-hour for electricity to transport irrigation water, according to a 15-month investigation by Environmental Working Group (EWG). Compared to Pacific Gas & Electric's agricultural rate, that's an annual subsidy of more than $100 million from U.S. taxpayers. EWG's report is available at www.ewg.org. It shows both the price paid by each CVP irrigation district in the years studied and the amount of energy the district used. Every year the CVP, the nation's largest federally subsidized irrigation system., moves more than 2 trillion gallons of water through 1,500 miles of canals. The electricity needed to move water around the CVP would power every home in Chico for 18 months. But just as CVP contractors pay heavily subsidized rates for their water, they pay next to nothing for the power that delivers it. Through the federal Freedom of Information Act, EWG obtained U.S. Bureau of Reclamation documents that enabled us to calculate, for the first time, the rate paid by CVP agribusinesses and the value of their power subsidy. We found: CVP power rates were 10 to 15 times lower than PG&E's industrial, agricultural or residential rates. In Westlands Water District, the largest and most politically powerful irrigation district in the CVP, power subsidies in 2002 were worth about $165,000 per farm. The CVP power sold to farms by the U.S. Bureau of Reclamation is essentially unregulated. No government agency, other than the Bureau itself, oversees its rates. "In an era when other Californians have been rocked by volatile electricity prices and the constant threat of rolling blackouts, a few thousand agribusinesses are guranteed dirt-cheap power, courtesy of U.S. taxpayers," said EWG Senior Analyst Renee Sharp, lead investigator for the report. "These subsidies are not helping small farms survive, but padding the profits of the biggest and richest farms." Cheap power is just the tip of the iceberg of federal subsidies to the CVP: Department of Agriculture data show that from 1995 to 2004, CVP agribusinesses received more than $890 million in direct commodity payments, mostly for cotton and rice. An earlier EWG investigation conservatively estimated the value of CVP water subsidies at $416 million in 2002. In total, federal subsidies to the CVP easily top more than half a billion dollars a year and could well reach $1 billion Ð all at taxpayers' expense. The report recommends that CVP agribusinesses should be required to pay prices approximating market rate for the power used to store and move irrigation water. A federal agency should regulate power rates to ensure system fairness, and should make these rates publicly available. CVP contractors, and contractors in other federal water projects, should not be allowed to "double-dip" and "triple-dip" on federal subsidies. # # # EWG is a nonprofit research organization based in Washington, DC that uses the power of information to protect human health and the environment. The group's research on Power Subsidies is available online at http://www.ewg.org/reports/powersubsidies/.

Asbestos and the Lungs

Disenfranchising Those with Lung Cancer More than 10,000 people a year die from asbestos disease, 5,000 of them from asbestos-caused lung cancer. It is precisely people like these, those most seriously harmed and dying from asbestos disease, that the Senate leadership has claimed to be helping with its series of asbestos trust fund bills. Few proposals have lived up to that claim, but the current proposal is perhaps the cruelest of all to date. The Specter/Leahy asbestos bill delivers unusually harsh treatment to victims of asbestos-caused lung cancer. First, the bill establishes criteria that are not recognized by the American Lung Association or the American Thoracic Society requiring that all lung cancer victims also have advanced-stage non-cancer asbestos disease in order to qualify for any level of assistance. But the more insidious disenfranchisement of lung cancer victims becomes apparent only when the exposure criteria in the bill are applied to a sample applicant. W.R. Grace Company Indicted on Federal Criminal Charges Read More This analysis reveals that the Specter/Leahy bill denies any and all compensation to people with confirmed asbestos-caused lung cancer if they entered the workforce after 1978, just four years after the peak of asbestos use in the U.S. of 1.4 billion pounds annually. Like all asbestos victims seeking justice, they will have their cases thrown out of court. But lung cancer victims whose asbestos exposure started after 1978 will never receive a penny from the fund because it will have expired before they can accumulate enough asbestos exposure under the newly minted exposure criteria in the bill. This disenfranchisement would affect even those people with asbestos-caused lung cancer who worked every year from 1978 through the termination of the fund in 2035 in what is characterized euphemistically as a "moderate" exposure environment, defined as working: "in areas immediate to where asbestos-containing products were being installed, repaired, or removed under circumstances that involved regular airborne emissions of asbestos fibers." (Section 121 (a) 16 (B)) For some lung cancer victims, compensation is even less likely. All individuals with a level VII claim, confirmed asbestos-caused lung cancer with bilateral pleural plaques, will have compensation denied if workplace exposure began after 1974. Lung cancer has a five-year mortality rate of 95 percent. The reason that all of these lung cancer victims receive nothing is the convoluted exposure criteria in the bill. These criteria declare, without any medical substantiation to support them, that every year of continuous daily exposure to asbestos that occurred after 1976 counts as just one half year, and if that exposure occurred after 1986, it counts only as one tenth of a year, or 36.5 days (Section 121 (a) 16 (E)). There is no medical or scientific rationale for devaluing a year of work exposure to "regular airborne emissions of asbestos" by 50 percent if that exposure was between 1976 and 1985 and by 90 percent if exposure took place after 1986. Asbestos use peaked in the U.S. in 1974, at 1.4 billion pounds; use in 1976 was clearly over 1 billion pounds, and workplace safety standards recommended by the National Institute of Occupational Safety and Health (NIOSH) were not adopted by the Occupational Safety and Health Administration (OSHA) until 1994 (NIOSH 2002), a full 18 years after the bill begins to devalue a year's worth of work around asbestos. Nor would full compliance with the OSHA standard mean that workers would not die at an excessively high rate from asbestos-caused lung cancer. The preamble to the OSHA standard itself estimates that one in every 300 workers will develop lung cancer from exposure at the legal limit (OSHA 1986). A more recent assessment concludes that one in every 200 workers will develop lung cancer if they are exposed to a career's worth of asbestos at the OSHA "safe" level. Compliance with OSHA's permissive standard is spotty. In 1999, asbestos air levels exceeded the far weaker pre-1980 "permissible exposure limit" at 13 percent of construction and 5.6 percent of manufacturing sites monitored (NIOSH 2002). This pre-1980 limit, which was established by the Mine Safety and Health Administration (MSHA) and still applies to mining, is 20 times less protective than the 1994 OSHA standard (0.1f/cc vs. 2 f/cc). Between 19 and 91 percent of all mining sites sampled between 1982 and 1991 exceeded the 1994 OSHA standard. In 1991, 32.4 percent of mining sites sampled exceeded this level. An example of the Specter/Leahy criteria The unfairness of the Specter/Leahy criteria are best understood by applying them to a hypothetical applicant to the fund who has lung cancer. For lung cancer level VII (with bilateral pleural disease) a person filing a claim with the trust would need 12 years of weighted exposure (pg 82). If exposure started in 1971, it would take 34 years of continuous exposure to meet the 12-year exposure requirement in the bill. This person, and everyone beginning continuous exposure in 1971 or earlier, would qualify for compensation, assuming all other criteria are met. For every year past 1971 that the person started working with asbestos under the "moderate exposure" criteria described above, it will take an extra 10 years of occupational exposure to meet the criteria for compensation in the bill. Thus, a person with asbestos-caused lung cancer and pleural plaques who began occupational exposure in 1974 would need 52 years of work exposure (through 2035, or "until" 2036) to meet the 12 year weighted exposure criteria in the bill. After that, the fund will have been terminated. 1974 - 1975 each year counts as a full year - total 2 years 1976 - 1985 each year counts as one half year - total 5 years 1986 - 2035 each year counts as one tenth year - total 5 years Example 1 Patient has lung cancer with bilateral pleural disease Example 2 Patient has lung cancer with 1/0 asbestosis Example 3 Patient has lung cancer with 1/1 asbestosis References National Institute for Occupational Safety and Health (NIOSH) (2002). "Work-related lung disease surveillance report." Division of Respiratory Disease Studies. Occupational Safety and Health Administration (OSHA). (1986). "Final Rule: Asbestos." 51 FR 22612. Department of Labor, Occupational Safety and Health Administration. June 20, Federal Register.

Fuel Economy Laws and Failure to Enforce

Real MPG: Putting the Truth in Your Tank The U.S. would have imported about 20 percent less foreign oil in 2005 if automakers met federal fuel efficiency or miles per gallon (MPG) standards based on real world driving conditions. That reduction is equivalent to more than 1.3 times the amount of oil imported from Saudi Arabia in 2005, or about two million barrels of oil per day. For consumers this translates into 33 billion gallons of gasoline saved that year. Instead, over the past 20 years, car company lobbyists and their friends in Congress have dramatically increased US dependence on foreign oil by prohibiting the EPA from requiring MPG tests that reflect how people actually drive. In the car company test for compliance with corporate MPG requirements, cars never exceed 60 miles per hour, never have the air conditioning on, never go up hills, never accelerate rapidly and always drive in perfect weather. According to several EPA analyses, these test results exaggerate real world MPG by about 25 percent for city driving and 30 percent on the highway. Bogus mileage tests are the cornerstone of car company compliance with government MPG standards. Since 1985, car companies have generally been required to meet fleet MPG averages of 27.5 for cars, and between 19.5-22.2 for trucks [†1]. Real world MPG is far lower, at about 21.7 for cars and 16.3 for trucks. Congress publicly identified this problem in 1980. If car company lobbyists, at that time, had not blocked congressional action to base federal fuel efficiency standards on real world driving conditions the U.S. would currently be saving 710 million barrels of oil per year, or about 20 percent of all the United States' imports in 2005. That is the equivalent of more than 1.3 times the 525 million barrels that the United States imported from Saudi Arabia last year. Significant oil savings do not require an increase in MPG standards. Congress could achieve vast savings simply by requiring automakers to stop deceiving the public and instead subject their vehicles to real fuel efficiency tests rather than the inaccurate, outdated tests currently prescribed by law. Many drivers know that the mileage number on their car's window sticker is inaccurate, and that cars rarely get the mileage that is advertised. But few people know that the number on the window is not the one that car companies use to meet corporate gas mileage standards. Instead, car company lobbyists and Congress have created what the Center for Auto Safety calls two sets of books when it comes to gas mileage (CAS 2004). This legally sanctioned deception dates back more than 25 years. In 1980, the U.S. House of Representatives Committee on Government Operations assessed the effectiveness of fuel efficiency standards that Congress had passed in 1975. The Committee found that: ...most new cars sold in this country do not achieve on road the fuel economy standards set by Congress. However, it should be noted that car manufacturers are deemed in compliance with the fuel economy standards mandated by Congress in 1975. American car owners and the entire U.S. economy will both be the losers if that situation is not remedied. Both will pay millions of dollars more, and both will remain more reliant on foreign oil sources, as a direct result of the needless waste of automobile fuel (HCOGO 1980). The Committee found that model year 1978 cars with government rated fuel efficiency of 27.5 miles per gallon achieved only 19 miles per gallon on the road, a shortfall of 30 percent that is essentially the same shortfall that occurs today. In addition, the Committee found that the shortfall between the government mileage ratings and real world driving could cause the U.S. to burn an extra one million barrels of gasoline per day by 1985. How the Automakers Drive/How You Drive The problem, the Committee found, was the grossly inaccurate testing procedures for measuring fuel efficiency; procedures that remain in place today. The city portion of the test is based on a simulated drive to work in Los Angeles in 1965 when congestion was much lower than it is today. The highway portion of the test was developed by the Environmental Protection Agency (EPA) in 1974 and was designed to represent a mix of interstate and freeway driving at a time when the national speed limit was 55 miles per hour. Congress eliminated the national speed limit in 1995 and states have instituted speed limits of 65 or 70 miles per hour (EPA FR 2006). Not surprisingly, neither the highway nor city test reflects real world driving behavior or gas mileage. One major difference is speed. On the highway test, cars average just 49 miles per hour and never exceed 60 miles per hour. Yet according to the EPA, recent reports show that 28 percent of all driving occurs at speeds greater than 60 miles per hour. Higher speed can dramatically reduce fuel efficiency (EPA FR 2006). In addition, the acceleration rates in both the city and highway tests are 3.3 miles-per-hour per second despite recent studies of real world driving which show that acceleration rates can be as high as 12 miles-per-hour per second. Rapid acceleration can seriously cut gas mileage. Even when the tests were developed, acceleration rates were higher in the real world. Yet, at the time, the dynamometers (treadmills for cars) on which the tests were completed did not allow for faster acceleration. Today's dynamometers allow for rapid acceleration even though rapid acceleration is not incorporated in mileage testing (EPA FR 2006). Other significant differences between the driving tests and real world driving are the use of accessories and ambient temperature. Neither the city test nor the highway test uses accessories such as air conditioning, heating or defrosting. Air conditioning in particular can reduce fuel efficiency. In addition, the tests are conducted at 75 degrees F even though only 20 percent of all driving occurs within five degrees of this temperature. Fuel efficiency is lower at temperatures that are above and below 75 degrees. Finally, because the tests are conducted on a dynamometer rather than on the road, the automakers do not have to account for a variety of conditions that can reduce fuel efficiency including roadway roughness, hills, wind, tire pressure, heavier loads (trailers, cargo, multiple passengers), the effects of ethanol in gasoline and others (EPA Preamble 2006). A Band-Aid Approach Despite these discrepancies, Congress and the automakers have resisted real change. In 1980, confronted by inaccuracies in the testing program, automakers General Motors and Ford suggested that the car labels be adjusted so that consumers would have more accurate information. However, the automakers opposed changing the driving test so that they would comply with federal fuel efficiency standards. "That approach is anathema to the auto makers," the Committee on Government Operations reported. Ford argued to the Committee that the testing procedures were fixed by law despite evidence that EPA could have modified the test. The Committee recommended changing the test to accurately reflect mileage for the 1986 and later model years. In 1984, the EPA adopted the approach favored by the automakers. Since that year, the Agency has adjusted the mileage figures produced by the driving test downward before placing the numbers on cars' window stickers (CAS 2004). The agency lowers the city test figure by 10 percent and the highway figure by 22 percent (EPA 2006). This adjustment provides consumers with somewhat more accurate information. But the test for determining compliance with fuel efficiency standards remains grossly inaccurate. Congress Ensures that Automakers are Falling Short The result of the inaccurate driving test is that automakers are failing to meet federal fuel economy standards established by Congress in 1975. Automakers' current fleet of cars must average 27.5 miles per gallon while SUVs and light trucks must average 22.2 miles per gallon. According to EWG's estimate, the true figures are closer to 21.7 miles per gallon for cars and 16.3 miles per gallon for SUVs and light trucks. A recent on-road study by Consumers Union of more than 300 cars and trucks found that 274 delivered lower fuel economy than promised by EPA (CU 2005). Consumers Union found that its estimated mileage for 2003 model year cars was 30 percent lower than that reported to the government for purposes of complying with federal fuel efficiency standards. This discrepancy is the same as that reported by the House Committee on Government Operations for 1978 model year cars. Moving toward Real MPG For more than a quarter century, federal law has required automakers to save oil by meeting mileage standards for their cars. This law grew out of concern over the United States' economic vulnerability to unstable foreign sources of oil. Congress acknowledged that one of the best ways to reduce this vulnerability is simply to use less oil. But as long as the mileage standards have been on the books, the automakers have evaded the spirit of the law by using a bogus driving test. The test allows automakers to claim that they are meeting federal mileage standards when in fact they are not. The losers in this scheme are citizens who must now pay $3.00 a gallon for gasoline to operate vehicles that deliver significantly less gas mileage than advertised. In addition, the U.S. is more dependent on foreign oil than ever before — in no small part because of the automakers' deliberate gas mileage deception. It does not have to be this way. EPA has designed emissions tests that incorporate many of the real-world driving standards and uses them to measure automakers' compliance with pollution emissions standards. For example, EPA tests auto emissions using a cold weather city driving test known as Cold FTP in which fuel efficiency is about 12 percent lower than in the normal city test. EPA also measures car pollution using a test with the air conditioning on known as SC03 that produces fuel efficiency numbers that are about 21 percent lower than in the normal city test. And EPA runs a third test known as the US06 that incorporates rapid acceleration and high speed. Results from this test are about 30 percent lower than mileage results from a composite of the normal city and highway tests. Acting on a petition by Bluewater Network, EPA recently announced that it plans to use these three tests to produce more accurate mileage stickers for consumers. But EPA has said that it will not use the tests to improve automakers' compliance with vehicles' fuel efficiency. Recommendations It's time for Congress to mandate one test for pollution, MPG compliance, and the sticker on the window in the showroom. Test methods similar to those found in Senate Bill 3543 would be a good start. It is outrageous that car companies have been allowed to deceive the American public for decades about the real MPG of their cars. Requiring a real driving test is not a substitute for enacting higher mileage standards for cars, but it is an essential step to making cars more efficient and to reducing dependence on foreign oil.

California - Toxic Chemicals

Stolen Inventory: Bush Rollback Will Hide Data on 600,000 Pounds of Toxic Chemicals in California The Bush Administration has adopted regulations that will dramatically roll back Americans' right to know about chemical hazards in their neighborhoods, allowing California industries to handle almost 600,000 pounds of toxic chemicals a year without telling the public, according to an investigation of federal data by Environmental Working Group (EWG). For more than 20 years, the U.S. Environmental Protection Agency's Toxics Release Inventory (TRI) program has required industrial facilities to report the release, disposal, incineration, treatment or recycling of 650 chemicals covered by the law. Comprehensive TRI reporting has been required for facilities that handle at least 10,000 pounds a year or manufacture 25,000 pounds per year, and discharge or dispose of at least 500 pounds per year of the listed chemical. But just before Christmas, the EPA gutted the TRI by sharply raising the detailed reporting threshold so that only releases of at least 2,000 pounds of chemicals will be subjected to detailed reporting. Facilities that don't meet the threshold must only indicate that they use a chemical. The agency adopted the rollback over the objections of more than 122,000 American citizens, corporations, government agencies and others who wrote in to protest the change. [OMB Watch 2006] EWG's investigation of TRI data from 2004 found that the proposed EPA rollback deals a crippling blow to Californians' access to information about toxic chemicals in their communities: The rollback will allow 274 industrial facilities in 30 counties to stop detailed reporting on the use or release of 595,422 pounds of hazardous chemicals a year. In Los Angeles County alone, 247,097 pounds of chemicals a year from 107 facilities will no longer be subject to reporting. In Alameda and Contra Costa counties combined, almost 66,000 pounds from 29 facilities will no longer be reported. In Orange County, more than 58,000 pounds from 27 facilities will no longer be reported. EPA Will End Detailed Reporting of nearly 600,000 Lbs. of Waste a Year in California County Facilities reporting releases between 500 and 2000 pounds and waste management activities up 5000 pounds in 2004 Number of facilities Emissions (pounds) Annual Reportable Amount (pounds) Los Angeles County 107 123,991 247,097 Contra Costa County 15 24,365 34,021 Orange County 27 23,111 58,202 San Bernardino County 19 19,341 34,542 San Diego County 16 18,768 39,496 Alameda County 14 12,961 31,918 Kern County 12 12,253 22,239 Solano County 4 7,091 16,219 Riverside County 4 6,691 14,091 Humboldt County 2 6,330 6,950 California Total 274 505,169 595,422 See Full List of Counties The rollback will allow 52 California facilities to stop reporting any details of their use or release of toxic chemicals. These facilities will be allowed to handle 69,426 pounds of toxic chemicals a year without detailed public disclosure. 52 Facilities Will Be Exempt From Detailed Waste Reporting Facility Facilities reporting releases between 500 and 2000 pounds and waste management activities up 5000 pounds in 2004 Number of chemicals Emissions (pounds) Annual Reportable Amount (pounds) Coatings Resource Corp., Huntington Beach 3 3,103 3,103 Westway Feed Products Co, Stockton 1 1,850 1,850 Distinctive Appliances Inc Aka Dacor, City Of Industry 1 1,728 2,592 Solvay Draka Inc., Commerce 1 1,705 1,710 Bardon Enterprises Inc, Santee 2 1,579 1,579 Century Plastics Inc, Compton 1 1,473 1,473 Prc-desoto International Inc., Glendale 1 1,450 1,450 Gillig Corp, Hayward 2 1,381 3,264 American Polystyrene Corp, Torrance 1 1,371 1,371 P.f.i. Inc., Santa Fe Springs 1 1,369 1,629 California Total 52 60,029 69,426 See Full List of Facilities Chemicals for which reporting will be slashed or curtailed are among the most hazardous to human health. The rollback will end annual reporting in California of more than 41,000 pounds of ethylbenzene, 10,000 pounds of styrene, 12,000 pounds of benzene and almost 16,000 pounds of chromium and chromium compounds - all known or suspected carcinogens. It will also eliminate annual reporting for more than 6,200 pounds of chemicals that meet the EPA's criteria for persistent bioaccumulative toxics, or PBTs - chemicals that present the greatest threats to human health and the environment. [EWG 2006]. Although the proposed rollback will reduce the total amount of chemicals used in California that must be reported to the TRI by less than 1 percent, reporting for many individual chemicals will drop sharply. All reporting will end for five different chemicals and reporting will drop by 10 percent or more for 69 chemicals. The TRI is the nation's premiere pollution reporting and citizens' right-to-know program. It is widely recognized as the least controversial environmental program in the country and has been praised by industry and environmentalists as an effective way to increase chemical use efficiency and reduce waste and pollution. The TRI is the only source of chemical-specific information on industrial pollution at the individual facility level. It is an essential source of information for state and local governments and community activists nationwide. Established in 1986, the TRI imposes no mandatory pollution controls on industry, but instead requires the reporting of estimated levels of release and disposal for 650 chemical compounds (less than one percent of chemicals registered for use in the U.S.) by some 23,000 facilities. This simple act of public disclosure is widely credited with spurring voluntary pollution reductions, with total U.S. chemical releases dropping 65 percent since 1989. [Hogue 2005]. In 2006, after the EPA first proposed rolling back the TRI, a report by a dozen state attorneys general, including Bill Lockyer of California, cited striking reductions achieved by industry since the program began: Boeing Company cut its toxic chemical releases by over 82 percent; Monsanto cut its toxic air emissions by over 90 percent; and the Eastman Chemical Co. cut its releases of TRI chemicals by 83 percent. [Spitzer 2006.] In January 2006, the attorneys general wrote to the EPA to protest the planned rollback, saying: "The proposed changes to the rule are not consistent with the purpose of TRI - to provide a maximum amount of information regarding toxic chemical use and releases to Americans - but directly contrary to the statutory purpose." The AGs said the proposed changes "violate the old saying: 'If it ain't broke, don't fix it.' " They said: The changes would significantly reduce the amount of information about releases of toxic chemicals available to the public and as a result would impair efforts by federal, state and local governments, workers, firefighters and citizens to protect Americans and their environment from the harm caused by discharges of toxic chemicals to the air, water and land. In addition to being contrary to the public interest and sound policy, the proposed changes would violate the Emergency Planning and Community Right-to-Know Act, the Pollution Prevention Act, and the Administrative Procedure Act. [Spitzer 2006.]

CDC Study on Breast Milk in Boston Area

New study from CDC and Boston University shows babies getting unsafe dose of perchlorate New study from CDC and Boston University shows babies getting unsafe dose of perchlorate, underscores need for federal action An Environmental Working Group (EWG) analysis of recently published data from scientists at the Centers for Disease Control (CDC) and Boston University (BU) shows that infants are being exposed to dangerous levels of the rocket fuel component perchlorate. The CDC/BU study, which examined breast milk from 49 Boston area women, found that the average infant in this study is being exposed to more than double the dose of perchlorate that the Environmental Protection Agency (EPA) considers safe; highly exposed babies are ingesting up to 10 times this amount. [1,2] Boston area infants are exposed to unsafe levels of perchlorate in breast milk At the 95th percentile perchlorate dose level in women with lower iodide intake, CDC found a 20% drop in thyroid hormone levels Calculations based on 4kg infant and average daily infant intake of 0.78 liters breast milk. Sources: 1, 3. If this weren't troubling enough, in September of 2006, the CDC published a study showing significant changes in thyroid hormone levels in women who were exposed to far less perchlorate than babies drinking breast milk in this study, and less than the EPA "safe" dose. [3] Since it is also well known that infants are at much greater risk for thyroid hormone disruption than adults, taken together, the findings of these two studies show that the perchlorate levels found in the breast milk of ordinary American women could be threatening the normal development of their exposed infants. [4] Perchlorate, the explosive ingredient in solid rocket fuel, has leaked from military bases and defense and aerospace contractors' plants in at least 22 states, contaminating drinking water for millions of Americans. The chemical has also been found to contaminate dairy milk, produce, and many other foods and plants. [5-12] In a related 2006 study, the CDC found perchlorate in the urine of every one of 2,820 people tested, suggesting that food is a key route of exposure in addition to drinking water. [13] Boston's tap water is not known to be contaminated with perchlorate; the 49 women in this study were likely exposed through food. [14] Infants are at greater risk for thyroid disruption by perchlorate than adults for several reasons. Perchlorate acts by inhibiting the thyroid gland's ability to take up the nutrient iodide, a key building block for thyroid hormone. Unlike adults, infants have minimal stores of thyroid hormones and must rely instead on their own daily production (breast milk does not contain significant quantities of thyroid hormone). Therefore, while adults may be able to use hormone stores to make up for temporary shortages related to chemical insults, infants can only do this to a very small degree. [4] While thyroid hormones regulate metabolism in adults and long-term deficiencies can lead to chronic health problems, the consequences for thyroid disruption in infants are much more serious. Normal thyroid hormone levels are critical for normal brain and organ development, and recent research has shown that infants can suffer permanent neurological deficits from even short-term thyroid hormone insufficiency. [15,16,17] On average, babies drinking breast milk in the Boston study would be exposed to 19 times more perchlorate than the September, 2006 CDC study found would depress thyroid hormone levels by 20 percent in adult women with lower iodide intake (thirty-six percent of women in the U.S. have urinary iodide levels in this "lower" range). [3] To make matters worse, the Boston study found that 47 percent of the babies tested were not getting adequate levels of iodine from breast milk. Since the effects of perchlorate are compounded by insufficient iodide consumption, these babies are at even greater risk for thyroid hormone disruption. [1] Notably, the Boston study also found that even moms who ingested extra iodine by using iodized salt or taking multivitamins containing iodine didn't always have sufficient iodine in their breast milk. [1] This finding is important because it underscores the need for the government to act to reduce perchlorate contamination of food and drinking water, rather than just simply pointing to iodized salt and multivitamins as quick fixes to the perchlorate problem. Earlier research confirmed—health protections still lacking The CDC/BU study confirms earlier research that found high levels of perchlorate in breast milk. [18,19] One study, for example, found perchlorate in every one of 36 samples of breast milk from nursing mothers in 18 states at levels as high as 92 parts per billion (ppb). [18] The Boston study found even higher levels of perchlorate among its 49 women, with a maximum concentration of a startling 411 ppb. The median perchlorate level in CDC/BU study was 9 ppb. [1] The Boston study also measured perchlorate concentrations in the mother's urine, finding a median level of 3.0 ppb. More important than the actual values, however, is the fact that these concentrations are remarkably similar to the levels of perchlorate that the CDC found in its much larger study of perchlorate exposure that tested the urine of more than 2,800 individuals. [13] In that study, the median urinary perchlorate concentration was 3.6 ppb. Since the perchlorate exposures in the two studies are so closely aligned, one can assume that the high levels found in the Boston women's breast milk are, unfortunately, probably typical of the general U.S. population. CDC's large study of urinary perchlorate levels also raises concerns about fetal exposures. CDC found that in the 36 percent of U.S. women with low iodine intake, almost any amount of perchlorate exposure was linked to a significant change in levels of thyroid hormones. [3] For about 1 in 10 of these women, exposure to perchlorate in drinking water at 5 ppb would result in subclinical hypothyroidism; this is a condition that requires treatment if these women become pregnant because it may negatively impact the brain development of their fetus if left untreated. [20] EWG estimates that there are more than 2.2 million women who fall into this latter category. [21] Conclusion Taken together, the weight of the evidence from these studies strongly support the conclusion that perchlorate is a major public health threat that needs to be addressed. Yet, there are still no federal safety standards for perchlorate in drinking water or food. Under pressure from the Pentagon and the defense industry, EPA has delayed setting a drinking water standard for perchlorate. California is in the final stages of adopting a perchlorate drinking water standard of 6 ppb, recommended by state scientists before release of the September, 2006 CDC study. The proposed standard in New Jersey is 5 ppb. Last July, Massachusetts adopted 2 ppb as the nation's first legally enforceable drinking water standard. Senators Boxer, Feinstein, and Lautenberg and Representative Solis from California have introduced legislation in the U.S. Senate and House of Representative that seeks to improve perchlorate monitoring and regulation to better protect public health. Recommendations Breast milk is by far the healthiest food for infants. However, the perchlorate levels found in breast milk in this CDC/BU study are alarming. The doses of pechlorate that infants are getting from ingesting this food are far higher than doses that have been shown to cause significant disruptions of thyroid hormone levels in many adult women. We also know that infants are more vulnerable than adults to the health effects of perchlorate exposure. The level of perchlorate found in breast milk in this study suggests a serious threat to the normal development and health of potentially all American infants. To protect public health: EPA must adopt a maximum contaminant level for perchlorate in drinking water based on the most recent science, including the 2006 CDC study and the Boston study described above. The 2006 CDC study showed convincingly, with statistically valid data from a large human population, that perchlorate levels well below the EPA's "safe" dose cause significant thyroid hormone depression in adult women of childbearing age. With the CDC study showing that even less than 1 ppb perchlorate in water may pose health risks to women, fully protective drinking water standards must be set as low as possible—at no more than 1 ppb—and revised downward as detection and cleanup technology improves. The Food and Drug Administration must also adopt an action level for perchlorate in food that is designed to protect the fetus, infants and children from the adverse effects of these exposures. References: [1] Pearce EN, Leung AM, Blount BC, Bazrafshan HR, He X, Pino S, Valentin-Blasini L, Braverman LE. 2007. Breast milk iodine and perchlorate concentrations in lactating Boston area women. Journal of Clinical Endocrinology and Metabolism epub Feb 2007. [2] Ginsberg G, Rice D. The NAS perchlorate review: questions remain about the perchlorate RfD. Environ Health Perspect. 2005 Sep;113(9):1117-9. Erratum in: Environ Health Perspect. 2005 Nov;113(11):A732. [3] Blount BC, Pirkle JL, Osterloh JD, Valentin-Blasini L, Caldwell LK. 2006a. Urinary perchlorate and thyroid hormone levels in adolescent and adult men and women living in the United States. Environmental Health Perspectives 114:1865-1871. [4] Ginsberg GL, Hattis DB, Zoeller RT, Rice DC. 2007. Evaluation of the U.S. EPA/OSWER preliminary remediation goal for perchlorate in groundwater: focus on exposure to nursing infants. Environmental Health Perspectives 115: 361-69. [5] California Department of Food and Agriculture. 2004. Data cited in: Sharp, R. 2004. Rocket fuel contamination in California milk. Environmental Working Group. Available at http://www.ewg.org/reports/rocketmilk/ [6] Danelski D., Beeman D. 2003. Special Report: Growing concerns: While scientists debate the risks, a study finds the rocket-fuel chemical in inland lettuce. The Press-Enterprise. April 27, 2003 [7] Environmental Working Group. 2003. Suspect Salads: Toxic rocket fuel found in samples of winter lettuce. Available at http://www.ewg.org/reports/suspectsalads/ [8] Environmental Working Group. 2004. Rocket fuel contamination in California milk. Available at http://www.ewg.org/reports/rocketmilk/ [9] Food and Drug Administration. 2004. Exploratory Data on Perchlorate in Food. Available at http://www.cfsan.fda.gov/~dms/clo4data.html [10] Kirk AB, Smith EE, Tian K, Anderson TA, Dasgupta PK. 2003. Perchlorate in milk. Environ Sci Technol. 37(21):4979-81. [11] Kirk AB, Martinelango PK, Tian K, Dutta A, Smith EE, Dasgupta PK. 2005. Perchlorate and Iodide in Dairy and Breast Milk. Environ Sci Technol. 39(7):2011. [12] Sanchez CA, Crump KS, Krieger RI, Khandaker NR, Gibbs JP. 2005. Perchlorate and nitrate in leafy vegetables of North America. Environ Sci Technol. 39(24):9391-7. [13] Blount BC, Valentin-Blasini L, Osterlow JD, Mauldin JP, Pirkle JL. 2006. Perchlorate exposure of the U.S. population, 2001-2002. J Exp Sci Environ Epidem, Online 18 October 2006. [14] Environmental Protection Agency. 2005. Unregulated Contaminant Monitoring Rule data. Updated January 2005. Available at www.epa.gov/safewater/ucmr/data.html [15] Zoeller, T. 2006. Collision of Basic and Applied Approaches to Risk Assessment of Thyroid Toxicants in forthcoming volume. Living in a chemical world: framing the future in light of the past. Annals of the New York Academy of Sciences, 2006: 168-190. [16] Haddow JE, Palomake GE, Allan, WC, Williams JR, Knight GJ, and Gagnon J, et al. Maternal thyroid deficiency during pregnancy and subsequent neuropsychological development of the child. New England Journal of Medicine 1999: 341: 549-555 [17] Pop VJ, Kuijpens J., van Baar, AL, Verkert, G. et al. 1999. Low maternal free thyroxine concentrations during early pregnancy are associated with impaired psychomotor development in infancy. Clinical Endocrinology 50: 149. [18] Kirk AB, Martinelango PK, Tian K, Dutta A, Smith EE, Dasgupta PK. 2005. Perchlorate and iodide in dairy and breast milk. Environmental Science and Technology 39: 2011-2017. [19] Kirk AB, Dyke JV, Martin CF, Dasgupta K. 2007. Temporal patterns in perchlorate, thiocyanate, and iodide excretion in human milk. Environmental Health Perspectives 115: 182-186. [20] Cooper, D. 2004. Sub-clinical thyroid disease: consensus or conundrum. Clinical Endocrinology 60: 410-412. [21] Environmental Working Group. 2006. Thyroid Threat: Under Proposed Rocket Fuel Standards, Many Women Would Need Treatment To Protect Baby. Available at www.ewg.org.

Some Facts About Sunscreens

Behind the Screen By: Shivani Vora May 14, 2007 - 4:41:20 AM Sunblock has had a few bad years, including class-action lawsuits and new claims that it causes—rather than prevents—cancer. How do you protect yourself this summer? You exercise regularly. You don’t smoke. You always wear your seatbelt. And when you’re in the sun, you never forget your SPF. Bases covered? Not so fast. Researchers at Harvard Medical School recently found that a vitamin D-deficiency—which can result from diligent sunscreen use—is linked to an increased risk of prostate cancer. Meanwhile, a class-action lawsuit is in progress in California against five major sunscreen manufacturers, claiming that their products don’t live up to their label claims of providing protection against UV rays or of being waterproof. Experts, however, warn that this brouhaha isn’t a reason to toss out your sunscreen. “There isn’t an epidemic of vitamin D deficiency,” says Coyle Connolly, a board--certified dermatologist in New Jersey, “but there is an -epidemic of skin cancer from too much sun -exposure.” To maintain adequate levels of vitamin D, says Dr. Connolly, just spend a few minutes in the sun, without sunscreen, over the course of each day. The lawsuits have drawn attention to one dirty secret of sunscreen, however: You have to be a real label hawk to know if your tube is truly “broad spectrum,” meaning that it protects you from both UVA and UVB rays. Any sunscreen with an SPF of 15 will block 94 percent of UVB rays, which penetrate the skin superficially, causing sunburn and skin cancer. UVA rays, on the other hand, cause up to 80 percent of sun-related wrinkles and age spots, and also increase your risk of skin cancer. UVA rays are trickier to fight because they penetrate the atmosphere even on cloudy days, and only four ingredients provide solid protection against them. Two of those ingredients are chemical sunblocks—avobenzone and Mexoryl SX—which work by absorbing and neutralizing UV radiation after it hits your skin, but before it can damage cells. The other two—zinc oxide and titanium dioxide—are physical sunblocks, which form a shield and actually reflect and disperse the radiation before it hits your skin. "Stay away from any sunscreen if it has an SPF of less than 15 or if it does not contain one of these four ingredients,” says Dr. Connolly. Which sunscreen you should grab depends on your needs. Chemical sunblocks are generally more waterproof, but they take 30 minutes to absorb into the skin, while physical sunblocks are effective as soon as you apply them and, because they are made from natural ingredients, can be less irritating. Mexoryl SX has been available in Europe for years, but it was not FDA approved until last year. It provides excellent protection against both short and long UVA rays, whereas the others primarily protect against long UVA rays. No matter which sunscreen you choose, David J. Leffell, MD, professor of dermatology at the Yale University School of Medicine, recommends reapplying it every couple of hours. “Ignore any claims about the longevity of sunscreen,” he warns. Even potions labeled “all day” wear off long before eight hours, he says, and sooner if you’re swimming or sweating. For Your Face Anthelios SX is a daily facial -moisturizer that combines Mexoryl SX and avobenzone to prevent wrinkles, sunspots, and cancer. Chemical sun--screens like these don’t cast a whitish pall over your face like titanium oxide and zinc oxide do. $29, laroche-posay.us.com For Your Lips Men get lip cancer at a much higher rate than women do because lipstick is a physical sunblock. NeoStrata SPF 15 Lip Conditioner ($6.50, neostrata.com) contains titanium dioxide for UVA protection. Most lip products with SPF (including ChapStick) contain oxybenzone for UVA protection, which experts say is not as effective as titanium dioxide, zinc oxide, or avobenzone. For Your Body Jack Black Ultra-Light Spray Sunscreen SPF 25 combines avobenzone for UVA protection with citronella to repel mosquitoes ($18, getjackblack.com). If bug bites aren’t a concern, try UV Expert 20, which combines Mexoryl SX, avobenzone, and titanium dioxide for complete coverage ($39, lancome-usa.com). Recommendations FDA has spent the past 29 years drafting sunscreen standards (FDA 2007), which it urges manufacturers to follow voluntarily. FDA has no public plan for setting a date by which these standards would finally become effective and mandatory. In lieu of enforceable standards, each sunscreen manufacturer decides on test methods, marketing claims, and the level of protection they are willing and able to provide consumers. Health authorities recommend sunscreen, but people are left wondering which of the hundreds of sunscreens on store shelves will best protect their and their families' skin from the sun. Sunscreens are the tip of the iceberg when it comes to ways that the chemical industry and the government are failing to protect public health. An extensive body of scientific literature demonstrates that everyone in the world carries in their body hundreds if not thousands of industrial chemicals at any given moment, the result of exposures to contaminants in air, water, and food, and to ingredients in everyday consumer products. No one understands the health implications of our exposures to complex mixtures of low doses of industrial compounds and pollutants: remarkably, federal health standards do not require companies to test their products for safety before they are sold, including nearly all chemicals in sunscreen and other personal care products, and the federal government approves new chemicals for the market using computer models to predict if they are toxic to humans. These are particularly risky methods given the many studies showing that these pollutants cross the placenta to contaminate babies even before the moment of birth, including a recent study conducted by EWG finding an average of 200 chemicals in umbilical cord blood from 10 newborn babies [read more]. This situation is unacceptable. To protect public health, including the health of the fetus, infant, child and others who are most vulnerable to toxic injury, we recommend: FDA must set mandatory sunscreen safety standards. As mandated by Congress, FDA must complete their safety standards (the "sunscreen monograph"), and establish a date by which these standards will become mandatory. This study confirms the need for mandatory standards — the voluntary system currently in place leaves the public with many sunscreen products that are not as safe and effective as the public needs and expects. FDA must develop UVA standards for sunscreen. While FDA has set guidelines for sunburn (UVB) protection, the agency has not established protocols and requirements for UVA protection. This is a critical gap in public health protection. UVA radiation is deeply penetrating and is linked to skin damage, including premature skin aging, wrinkling, and possibly cancer. FDA is charged with regulating sunscreen and protecting public health, and both of those charges demand that the agency set standards for UVA protection. FDA must approve new, effective and safe sunscreens for use in the U.S. Some sunscreen chemicals have been under review at the Agency for over than a decade. Effective sunscreens not approved in this country are in widespread use elsewhere in the world. FDA sorely needs to streamline and modernize its sunscreen review process to give consumers access to the best products possible. In the larger picture, our system of public health protections allows the vast majority of industrial chemicals to enter commerce with no requirement for premarket safety testing, even for chemicals that will end up in the bodies of Americans from their everyday exposures to ingredients in consumer products. Many state and local organizations and coalitions like the Campaign for Safe Cosmetics are working for important changes that help close the gaps in our system of public health protections. We not only need sunscreens guaranteed to be safe and effective, but we also sorely need policies that would require companies to document the safety of chemicals before they go on the market. And, most importantly, we need policies that would require that chemicals be safe for the fetus, infant, and other vulnerable populations — a simple, commonsense idea completely absent from current federal law. Such advances would dramatically improve our understanding of health impacts from chemical exposures, and would go a long way toward sealing the gaps that leave consumers at risk from a lifetime of exposure to chemicals. U.S. lags behind the world in sunscreen safety and effectiveness. FDA has approved just 17 sunscreen active ingredients for use in the U.S. In Europe 29 have been approved, including some that are more effective than those available here, particularly for blocking UVA. When FDA issued their so-called final monograph for sunscreens (which they subsequently stayed indefinitely at the request of industry), they received multiple petitions urging that they review active ingredients approved for use in Europe. The Agency replied it would "address sunscreen active ingredients that have foreign marketing experience and data at a future time," a hollow promise if their 30-year track record on developing sunscreen standards is any indication. FDA faces pressure from industry, states, and Congress to set UVA standards and approve new UVA sunscreens to protect the public. The industry's trade association petitioned the agency to approve new UVA filters beginning in 2003 (CTFA and CHPA 2003). In a May 2007 letter to FDA's commissioner, six senators urged the agency to finish setting UVA standards for sunscreen (Dodd 2007). They reminded the Commissioner that the agency had missed the Congressisonally mandated deadline of May 2006 for finalizing the draft sunscreen standards, including new UVA standards. "We continue to find this baffling [the lack of UVA standards] since many other countries, including the European Union, have adopted sunscreen standards including UVA to protect their citizens," they wrote. FDA has not reviewed or approved new, effective sunscreens available in other countries.