FDA Lacks Data, Power To Review Engineered FoodsWASHINGTON, DC, January 7, 2003 (ENS) - The Food and Drug Administration (FDA) lacks both the authority and the information to evaluate the safety of genetically engineered (GE) foods, according to the nonprofit Center for Science in the Public Interest (CSPI).
A new report from the group says that while the few GE food crops now on the market appear to be safe, the FDA is ill equipped to assure the safety of future foods that will be engineered in complex ways.
Biotechnology companies are now encouraged - but not required - to submit safety testing data to the FDA for its review. CSPI's examination of 14 such submissions obtained under the Freedom of Information Act found that companies sometimes refused FDA requests for more information.
Monsanto, CIBA-Geigy (now Syngenta), and Dow AgroSciences, for instance, each declined to provide requested scientific data to the FDA about strains of GE insect resistant corn.
"The voluntary notification process by which the FDA reviews safety data for new crops allows biotechnology companies to safely ignore FDA requests for more information," said Doug Gurian-Sherman, science director of CSPI's biotechnology project and the report's author. "Without a legally mandated approval process, the FDA can only review whatever data that a company lets it review."
The CSPI report also found technical shortcomings in the safety data provided by biotech companies, as well as some errors that the FDA failed to detect. Submissions from Exelixis (formerly Agitrope) about tomatoes and cantaloupe engineered for delayed ripening, for example, contained erroneous and unsupported conclusions that went unremarked upon by the FDA, the report charges.
The report also found that one genetic engineering developer used inadequate methodology to test for allergens, and that others failed to evaluate toxicants and anti-nutrients. Errors like those might have been caught by observers outside the government, had the process not been secret, said Gurian-Sherman.
The first recommendation in the CSPI report is to replace the voluntary notification system with a mandatory pre-market approval system that requires biotechnology companies to submit much more detailed testing information and obtain FDA approval before marketing the product. Legislation that would make these changes was introduced last fall by Senator Dick Durbin, an Illinois Democrat who is expected to reintroduce the bill this year.
Even without legislation, CSPI argues, the FDA can take steps to give consumers greater confidence that the GE foods the agency reviews are safe. The group says the FDA should develop detailed safety testing guidelines for biotech developers.
"We found that biotech companies weren't always performing the right tests to look for potentially dangerous compounds, including allergens, and that there was a great deal of unevenness among different developers' submissions," said Gurian-Sherman. "But the FDA isn't giving companies enough guidance about what tests companies should conduct, or how much data companies should provide."
GE crops have the potential to provide enormous benefits to both consumers and the environment, according to CSPI's report. But the group warns that the technology's life span would be short if dangerous biotech products were to show up on supermarket shelves.
"The public will - and should - only have confidence in GE foods if the government formally approves them as safe after a thorough and transparent review," said Gurian-Sherman. "The biotech industry itself should be clamoring for that kind of a process."
Today, Gurian-Sherman presented CSPI's concerns at a meeting of a committee of the National Academy of Sciences (NAS) that is reviewing some of the food safety aspects of GE crops.
"I hope the NAS committee will provide the FDA and industry with specific advice on the kinds of tests that should be done," Gurian-Sherman said.
Klamath Water Diversions Caused Fish KillOAKLAND, California, January 7, 2003 (ENS) - Federal water diversions from the Klamath River were the primary cause of a massive fish kill in the Klamath River last September, concludes a new report from the California Department of Fish and Game (DFG).
More than 33,000 adult salmon, including federally protected coho, died before they could spawn because of federal water diversions to upstream farmers. The lack of water in the river caused river temperatures to rise and dissolved oxygen levels to drop, creating lethal conditions for salmon, the report finds.
The returning fish crowded together in a few spots where cooler tributaries brought colder water into the river. Infectious bacteria and parasites swept through the schooled fish, killing almost all and weakening the rest.
"DFG concludes that low flows and other flow related factors (e.g. fish passage and fish density) caused the 2002 fish kill on the lower Klamath River," the report states. "Furthermore, of the conditions that can cause or exacerbate a fish kill, flow is the only factor that can be controlled to any degree."
"This report confirms that the Bush administration killed more than 33,000 salmon," said Kristen Boyles, an Earthjustice attorney. "And the truth is the tragedy on the lower Klamath River could be repeated unless the plan for federal irrigation is overhauled."
In March 2001, Interior Secretary Gale Norton attended a ceremonial release of water to farmers in the Klamath River basin. The water had been withheld the previous year due to concerns over endangered fish, but under a new 10 year management plan, the water would continue to be provided to the farmers despite risks to fish.
The California DFG warns that more damaging fish kills are likely under the current federal plan saying, "There is a distinct potential for future fish kills considering that pathogens are always present, temperatures are normally at levels that can cause disease and, under the 2002 BO [biological opinion] flow prescription, a moderate sized run of salmon and steelhead can generate high enough fish densities in the lower Klamath River to result in a major fish kill.
Earthjustice is challenging the 10 year federal irrigation plan blamed for the fish kill on behalf of commercial fishers, conservation groups and Representative Mike Thompson, a California Democrat who represents northern California coastal communities that were hit economically by the fish kill.
The plaintiffs charge that the irrigation plan ignores the best available science, and was approved in a biological opinion issued by the National Marine Fisheries Service (NMFS) after NMFS overruled one of its own scientists who warned that the irrigation guidelines would damage the river ecosystem and the salmon fishery.
"The current federal water plan ignores science, and instead relies on guess work, wishful thinking, and voluntary measures," said Glen Spain of the Pacific Coast Federation of Fishermen's Associations Northwest Office in Oregon. "This is the water plan that killed the fish. Why should farmers have all the water they need while coastal fishing dependent communities and fishing families wind up with dead fish and dry rivers?"
Nuclear Licenses Need Not Consider Terrorism ThreatWASHINGTON, DC, January 7, 2003 (ENS) - The threat of terrorism is too nebulous to be considered when licensing nuclear reactors and other such facilities, the Nuclear Regulatory Commission (NRC) has concluded.
The NRC, responsible for reviewing the environmental and safety impacts of proposed new and renewed nuclear materials licenses, said that despite the concerns raised by the September 11, 2001 terrorist attacks, it considers the potential for such attacks too speculative to be considered in licensing reviews.
The NRC concluded that it is not obligated to evaluate the environmental impacts of terrorist attacks in reviews required under federal law by the National Environmental Policy Act (NEPA). "The possibility of a terrorist attack ... is speculative and simply too far removed from the ... consequences of agency action to require a study under NEPA," the NRC wrote.
The Nuclear Control Institute (NCI), a non-proliferation research and advocacy center, condemned the NRC's decision.
"NRC's ruling that the risk of terrorist attack is 'speculative' is completely absurd in the post September 11 era," said NCI president Dr. Edwin Lyman. "For a government agency to make such a statement in today's elevated threat environment is irresponsible and dangerous."
The decision came in an NRC review of a proposed mixed oxide (MOX) fuel facility that would be built by Duke Energy and its partners at the Savannah River Site in South Carolina, which would turn surplus weapons grade plutonium into fuel for commercial nuclear reactors. The NRC overturned an earlier decision by the Atomic Safety and Licensing Board panel in the MOX fuel plant case that terrorist acts in the post September 11 era must be considered "reasonably foreseeable" under NEPA and should be evaluated in an Environmental Impact Statement.
The review also covered two existing Duke power plants that would be converted to burn MOX fuel, and nuclear store projects in Utah and Connecticut. At the Utah storage site, for example, the commission said, "we have no way to calculate the probability" of an attack or its consequences, "except in such general terms as to be nearly meaningless."
The NRC said that rather than exploring the potential environmental effects of "a third party attack" on a nuclear site, security should be improved at all nuclear sites and around the entire nation. Reviewing the potential impacts of an attack in licensing hearings could provide information to terrorists, the NRC said, and might "unduly alarm the public."
"These NRC decisions set a terrible precedent," Dr. Lyman warned. "One of the greatest dangers we face today is that many nuclear facilities are located near heavily populated urban areas and could cause environmental catastrophes if attacked by terrorists. NRC has no excuse after the September 11 attacks to ignore the potentially devastating environmental and public health impacts of terrorist attacks when making decisions under NEPA about designing, siting or modifying hazardous facilities."
Lawsuit Challenges Exemptions for Farm RunoffSACRAMENTO, California, January 7, 2003 (ENS) - A coalition of environmental groups has filed the first challenge to a controversial decision made last month by the Central Valley Regional Water Quality Control Board (CVRWCB) waiving reporting and permitting requirements for agricultural pollution discharges to the waters of the Central Valley.
DeltaKeeper, CalPIRG, Earthjustice, Natural Resources Defense Council (NRDC), The Ocean Conservancy and California Sportfishing Protection Alliance filed an appeal of the decision with the state Water Resources Control Board, the agency that oversees water quality for California.
"The regional board's rushed decision was motivated by a desire to protect agricultural dischargers rather than protect California's water quality," said DeltaKeeper Bill Jennings. "We are looking to the state board to put the regional board's priorities back on the right track and create a meaningful and effective pollution control program for the Central Valley agricultural industry."
On December 5, the CVRWCB decided to waive oversight of agricultural irrigation waters and runoff for another two years. An existing waiver, which the Board issued in 1982, was scheduled to end on January 1. In issuing the new waiver, the Regional Board relieved the agricultural industry from having to comply with water quality requirements that apply to thousands of other business, small and large, throughout California.
The Regional Board made the decision following a packed public hearing on the issue of extending waivers for farm runoff in the Central Valley from water quality regulations, at which many concerned citizens voiced opposition to the proposed waiver.
"The Central Valley Water Board did not carefully consider all of the scientific evidence establishing the devastating impacts of agricultural discharges on the waters and wildlife of the Central Valley," said Jennings. "The board failed to do its homework and, under pressure from big agribusiness, hastily made a decision that endangers the health of California citizens, and fish in our waterways."
The environmental organizations' appeal charges that the Regional Board's decision is too vague and illegally waives requirements for discharges that are resulting in violations of water quality standards for fishing and drinking.
"The waiver goes too far, basically asking the dischargers to come up with their own programs," explained Mike Lozeau of Earthjustice, the environmental law firm representing the groups. "The Regional Board cannot with a straight face think that more voluntary efforts by the agricultural industry - the results of which since 1982 are vast stretches of polluted waters in the Valley - suddenly will prove effective."
The appeal asks the state board to conduct its own evidentiary hearing and design an appropriate regulatory program for agricultural pollution discharges to Central Valley waters. The groups have also submitted a review by the NRDC showing that agricultural pollutants, such as pesticides, fertilizers and sediment, can be reduced or eliminated from farm runoff.
"Innovative California growers have already proven that alternative practices work," said Jonathan Kaplan of the NRDC. "We'd like to see the Water Boards level the playing field by asking all growers to do their share."
Smog Not Beneficial, EPA ConcludesWASHINGTON, DC, January 7, 2003 (ENS) - The U.S. Environmental Protection Agency (EPA) has rejected an argument that ground level ozone, or smog, provides protection from harmful ultraviolet radiation, and should therefore be considered beneficial to humans.
A final decision published by the EPA on Monday found a lack of scientific support for industry claims that ground level ozone is beneficial, and states that it would be inappropriate to weaken existing smog standards. The finding came in the EPA's response to a May 1999 court ordered remand in the lawsuit American Trucking v. USEPA, a case in which industry launched a multi-pronged challenge to the 1997 national air quality standards for ozone.
"Industry's efforts to equate smog with sun block is yet another dodge by polluters who don't want to clean up," said Howard Fox of Earthjustice, which represented the American Lung Association in the case. "Asthmatics, kids, and others who suffer the health impacts of smog need the improved protection offered by these standards."
According to EPA estimates, the 1997 standards, once implemented, will prevent tens of thousands of occurrences of respiratory symptoms such as painful breathing, reductions of lung function, and asthma attacks-as well as many hospital admissions and emergency room visits. During the EPA's deliberations on the 1997 standards, industry argued that controlling ground level ozone - also known as tropospheric ozone - could harm public health by allowing more ultraviolet B sunlight to reach earth.
In the 1999 American Trucking decision, the U.S. Court of Appeals for the DC Circuit directed the EPA to consider the issue, although the court expressed no opinion on what conclusion the agency should reach.
"These industry claims are nonsense," said John Kirkwood, president and chief executive officer of the American Lung Association. "Ozone is a toxic gas that is like getting a sunburn on your lungs. How can this possibly be beneficial? We applaud EPA for rejecting this pseudo-science argument."
After considering public comments, EPA decided to reaffirm the 1997 standard, indicating that the allegations about ultraviolet sunlight are "too uncertain at this time to warrant any relaxation in the level of public health protection previously determined to be requisite to protect against demonstrated direct adverse respiratory effects of exposure to O3 [ozone] in the ambient air."
Moreover, the EPA expressed the view that the influence of ground level ozone on ultraviolet radiation is likely "very small from a public health perspective."
Small Timber Sales Could Be Exempted from ReviewWASHINGTON, DC, January 7, 2003 (ENS) - The U.S. Forest Service (USFS) has proposed loosening the environmental documentation requirements for small timber sales designed to reduce wildfire risk.
On Friday, the USFS proposed to simplify documentation under the National Environmental Policy Act for three new categories of small timber sales. The proposed categories apply to management activities that the USFS says "do not significantly impact the environment," such as salvaging dead and dying trees and removing insect infested or diseased trees to prevent larger infestations.
The proposed categories would be applied to projects up to 250 acres in size. They would be used for removing trees "posing a hazard to public safety" due to their potential for supporting catastrophic fires, such as those containing small insect and disease outbreaks.
The proposed new categories would not be subject to administrative appeal because of their limited scope, the USFS said.
The first of the three proposed categories for exclusion from review would allow harvest of live trees not to exceed 50 acres. The second would allow salvage of dead and/or dying trees not to exceed 250 acres. The third would allow removal of any trees necessary to control the spread of insects and disease on no more than 250 acres.
None of the proposed categorical exclusions would allow more than one-half mile of temporary road construction. They would not be used in areas where there could be adverse effects on threatened and endangered species or their designated critical habitat, wilderness areas, inventoried roadless areas, wetlands, and archeological or historic sites.
"Categorical exclusions like those we are proposing will assist the agency in meeting its mission of caring for the land," said USFS Chief Dale Bosworth. "The proposed categories are about how we document our decisions regarding activities that are environmentally safe. Through these proposed categories, the agency hopes to reduce the bureaucratic red tape and save time, energy and money in preparing small, routine, projects that are supported by local communities."
Bosworth said a 2001 review of 154 recent low impact forest management activities showed "no significant effect on the environment" and therefore should not require lengthy documentation.
Comments on the proposed categories will be accepted for 60 days.
Free Battery Recycling Offered to Public AgenciesATLANTA, Georgia, January 7, 2003 (ENS) - Rechargeable battery recycling will be made available to public agencies free of charge under a new program from the Rechargeable Battery Recycling Corporation (RBRC).
The RBRC, a non-profit public service organization dedicated to recycling rechargeable batteries, announced Monday that any public agency that wishes to participate in its Charge Up to Recycle!® battery recycling program may do so free of charge beginning this month.
In 2001, RBRC omitted fees associated with its community recycling program. Starting this month, the program will be available at no charge to public agencies as well. This includes federal, state and local governmental agencies, public hospitals, police and fire departments, and military institutions.
Since RBRC lifted its participation fees for communities, they have seen an increase in program participation of 21 percent.
"The reaction from the community to providing a free recycling program has been extremely positive. Offering the program free of charge to public agencies is the next step in helping to recycle as many rechargeable batteries as possible," said Ralph Millard, executive vice president, RBRC.
"While so many public programs, including those involving recycling, are getting either cut or reduced significantly, the RBRC program is growing and expanding," Millard added. "Even more important - the public does not have to absorb any costs associated with implementing the program."
RBRC will handle the collection of all small portable rechargeable batteries, including nickel-cadmium (Ni-Cd), nickel metal hydride (Ni-MH), lithium ion (Li-lon) and small sealed lead (Pb) rechargeable batteries. RBRC will provide two or five box collection kits at no cost - each box holds about 40 pounds of rechargeable batteries and is valued at $50.
RBRC will pay for all shipping, materials, processing and recycling costs.
More than 700 public agencies in the United States and Canada now take part in the Charge Up to Recycle! (R) program. These agencies are in addition to the over 30,000 retail locations and over 700 community programs across the U.S. and Canada participating in the RBRC program.
Rechargeable batteries are found in a wide range of portable electronic products, including cellular and cordless phones, two-way radios, camcorders, laptop computers and cordless power tools. Consumers can find the nearest rechargeable battery drop off location by calling 1-800-8-BATTERY or by going online at: http://www.rbrc.org
Designer Diets Produce Fish Packed with NutrientsWEST LAFAYETTE, Indiana, January 7, 2003 (ENS) - Farm raised fish eating designer menus could help people obtain their recommended daily allowance of fatty acids.
Purdue University researchers say fish that eat diets high in fatty acids could be beneficial to the health of the people eating the fish. Fatty acid feed supplements for fish may help people get government recommended amounts of macronutrients, said Paul Brown, a Purdue forestry and natural resources professor.
The additive Brown is testing is a type of omega-6 fatty acid called conjugated linoleic acid (CLA), which researchers have found is a weapon against cancers and diabetes.
The National Academy of Sciences Institute of Medicine has recommended that people increase their consumption of food containing alpha-linoleic acid (an omega-3 fatty acid) and linoleic acid (an omega-6 fatty acid). The institute set the daily requirements, or Dietary Reference Intakes, of these macronutrients necessary to maintain health, and noted that cold water fish, such as swordfish, tuna and salmon, are prime sources of omega-3.
Omega-3 and omega-6 are essential fatty acids, meaning they are important for health, but the human body can not produce them. Fish and shellfish are good sources of omega-3 fatty acids important for building cells, for brain, nerve and eye function, and for lowering risks of high cholesterol, cardiovascular diseases and cancer.
"Fish have always been the original and standard measure for good sources of omega-3," Brown said. "But now we find that we can introduce other fatty acids into fish. Next we must determine if there is an optimum ratio of omega-3 and omega-6 fatty acids that is healthy."
Special fish diets using additives, such as CLA, and grains, such as soybeans, can be formulated to produce designer fish that are high in beneficial fatty acids, Brown said. The research team is studying different fish species to chronicle their development on specialized diets and determine how much of the nutrients they retain.
The ability to raise more nutritional fish of a variety of species should encourage growth of the aquaculture industry, Brown added. But most fish are still obtained from the wild.
"The wild fish supply just isn't sufficient to provide us with the amount necessary for human consumption," Brown said. "That was decided in 1989 when we hit maximum sustainable yield from the world's oceans, yet the world population is still increasing."
"We have to develop new aquaculture production that rivals global production of soybeans, pigs and chickens if we want to keep eating fish and shellfish," concluded Brown.