Drilling in Deep Water. WSJ Editorial
A ban on offshore production won't mean fewer oil spills.WSJ, May 04, 2010
It could be months before we know what caused the explosion and oil spill below the drilling rig Deepwater Horizon. But as we add up the economic costs and environmental damage (and mourn the 11 oil workers who died), we should also put the disaster in some perspective.
Washington is, as usual, showing no such restraint. As the oil in the Gulf of Mexico moves toward the Louisiana and Florida coasts, the left is already demanding that President Obama reverse his baby steps toward more offshore drilling. The Administration has partly obliged, declaring a moratorium pending an investigation. The President has raised the political temperature himself, declaring yesterday that the spill is a "massive and potentially unprecedented environmental disaster."
The harm will be considerable, which is why it is fortunate that such spills are so rare. The most recent spill of this magnitude was the Exxon Valdez tanker accident in 1989. The largest before that was the Santa Barbara offshore oil well leak in 1969.
The infrequency of big spills is extraordinary considering the size of the offshore oil industry that provides Americans with affordable energy. According to the Interior Department's most recent data, in 2002 the Outer Continental Shelf had 4,000 oil and gas facilities, 80,000 workers in offshore and support activities, and 33,000 miles of pipeline. Between 1985 and 2001, these offshore facilities produced seven billion barrels of oil. The spill rate was a minuscule 0.001%.
According to the National Academy of Sciences—which in 2002 completed the third version of its "Oil in the Sea" report—only 1% of oil discharges in North Americas are related to petroleum extraction. Some 62% of oil in U.S. waters is due to natural seepage from the ocean floor, putting 47 million gallons of crude oil into North American water every year. The Gulf leak is estimated to have leaked between two million and three million gallons in two weeks.
Such an accident is still unacceptable, which is why the drilling industry has invested heavily to prevent them. The BP well had a blowout preventer, which contains several mechanisms designed to seal pipes in the event of a problem. These protections have worked in the past, and the reason for the failure this time is unknown. This was no routine safety failure but a surprising first.
One reason the industry has a good track record is precisely because of the financial consequences of accidents. The Exxon Valdez dumped 260,000 barrels of oil, and Exxon spent $3.14 billion on cleanup. Do the math, and Exxon spent nearly 600 times more on cleanup and litigation than what the oil was worth at that time.
As for the environmental damage in the Gulf, much will depend on the weather that has made it more difficult to plug the leak and contain the spill before it reaches shore. The winds could push oil over the emergency containment barriers, or they could keep the oil swirling offshore, where it may sink and thus do less damage.
It is worth noting that this could have been worse. The Exxon Valdez caused so much damage in part because the state of Alaska dithered over an emergency spill response. Congress then passed the 1990 Oil Pollution Act that mandated more safety measures, and it gave the Coast Guard new powers during spill emergencies. We have seen the benefits in the last two weeks as the Coast Guard has deployed several containment techniques—from burning and chemical dispersants to physical barriers. America sometimes learns from its mistakes.
On the other hand, Washington's aversion to drilling closer to shore has pushed the industry into deeper, more difficult, waters farther out to sea. BP's well is 5,000 feet down, at a depth and pressure that test the most advanced engineering and technology. The depth complicates containment efforts when there is a disaster.
As for a drilling moratorium, it is no guarantee against oil spills. It may even lead to more of them. Political fantasies about ending our oil addiction notwithstanding, the U.S. economy will need oil and other fossil fuels for decades to come. If we don't drill for it at home, the oil will have to arrive by tanker and barges. Tankers are responsible for more spills than offshore wells, and those spills tend to be bigger and closer to shore—which usually means more environmental harm.
The larger reality is that energy production is never going to be accident free. No difficult human endeavor is, whether space travel or using giant cranes to build skyscrapers. The rest of the world is working to exploit its offshore oil and gas reserves despite the risk of spills. We need to be mindful of such risks, and to include prevention and clean up in the cost of doing business, but a modern economy can't run without oil.
Showing posts with label industry. Show all posts
Showing posts with label industry. Show all posts
Monday, May 3, 2010
Tuesday, March 16, 2010
The U.S. in the World Race for Clean Electric Generating Capacity
The U.S. in the World Race for Clean Electric Generating Capacity
IER, March 15, 2010
China has already made its choice. China is spending about $9 billion a month on clean energy. It is also investing $44 billion by 2012 and $88 billion by 2020 in Ultra High Voltage transmission lines. These lines will allow China to transmit power from huge wind and solar farms far from its cities. While every country’s transmission needs are different, this is a clear sign of China’s commitment to developing renewable energy.
The United States, meanwhile, has fallen behind.
– U.S. Secretary of Energy, Steven Chu
In an attempt to generate support for implementing a cap on carbon dioxide, Energy Secretary Steven Chu and others paint a very dire picture of the U.S.-vs.-China race for clean energy, implying that China is quickly outstripping us in that race.[i] However, all the facts are not on the table. In both 2008 and 2009, the U.S. added more non-hydroelectric renewable capacity than it added traditional capacity (natural gas, coal, oil, and nuclear).[ii] At the end of 2009, the U.S. ranked first in wind capacity in the world with China’s wind capacity about 30 percent less than the U.S. level. At the end of 2008 (the most recent data available), the U.S. ranked fourth in solar capacity, with only Germany, Spain, and Japan having a larger amount. Where China is outstripping us in domestic construction is in coal-fired, nuclear, and hydroelectric generating technologies. Because of U.S. legal and regulatory red tape, it is much harder to build these energy technologies in the U.S. than in China.
What Does the Capacity Data Show for Wind and Solar Power?
According to the Solar Energy Industries Association, the U.S. ranks fourth in the world in solar capacity with 8,800 megawatts at the end of 2008.[iii] Germany, Spain, and Japan, in that order, had larger amounts of solar power at the end of 2008 than the U.S.[iv] China had just 0.3 megawatts of installed solar PV capacity at the end of 2009[v] or 0.003 percent of the solar capacity of the U.S.
According to the Global Wind Energy Council, the U.S. leads the world in wind generating capacity, with 35.2 gigawatts at the end of 2009; Germany is second with 25.8 gigawatts, and China is third with 25.1 gigawatts.[vi] In 2009, the U.S. installed almost 10 gigawatts of wind capacity, a record,[vii] and China installed 13 gigawatts.[viii]
Why is China Building Wind and Solar Capacity?
China builds wind and solar because ratepayers in other countries are paying them to do so. China has been taking advantage of the Clean Development Mechanism (CDM) under the Kyoto Protocol to obtain funding for its solar and wind power.[ix] Under this program, administered by the United Nations, wealthy countries can contribute funds and get credit for “clean technology” built elsewhere as long as it is additional, that is, as long as that technology would not have been built otherwise. China is the world’s largest beneficiary of the program and has benefited to the point where 30 percent of its wind capacity is not operable because it is not connected to the grid.[x] However, in mid 2009, the U.N. started questioning whether the Chinese CDM program was in fact “additional,” because the U.N. found that China was lowering its subsidies to qualify for the program.[xi] That is, China was reducing its own government’s support in order to get international subsidies.
How Do the U.S. and China Electric Construction Programs Compare?
While China is building non-hydro renewable slightly faster than the United States, overall it is building new electrical generation much, much faster than the United States. The most comparable international database on electric generating capacity is found on the Energy Information Administration (EIA) website.[xii] Comparing the electric generating capacity data by technology type for the two countries, at the end of 2007 (the last year of comparable data), the Chinese had a total of 716 gigawatts of generating capacity, about 280 gigawatts less than the 995 gigawatts of capacity in the U.S.
The U.S. has been building generating capacity at a very slow rate, adding between 8 and 15 gigawatts a year since 2004. The Chinese in contrast, to fuel their bulging economy, have added between 75 and 106 gigawatts a year, from 2004 to 2007. Based on Secretary Chu’s comments, one might think that the additional capacity that China was adding was all non-hydroelectric renewable and nuclear capacity. However, that has not been the case. Between 2004 and 2007, the Chinese have added 226 gigawatts of fossil fuel generating capacity, 40 gigawatts of hydroelectric capacity, 2 gigawatts of nuclear capacity, and only 6 gigawatts of non-hydro renewable capacity.
What are China’s Electric Construction Plans?
Both China’s generating sector and its industrial sector rely heavily on coal, with 79 percent of its electric generation being coal-fired.[xiii] According to the National Energy Technology Laboratory (NETL), from 2004 through 2007, China has been building 30 to 70 gigawatts of coal-fired power a year, and has about 70 gigawatts more under construction. NETL sees China building over 185 gigawatts of coal-fired plants in the future.[xiv] (See figure below.)
According to Australia, China is planning to build 500 coal-fired plants over the next ten years.[xv] That means: every week or so, for the next decade, China will open another large coal-fired power plant.[xvi] Australia has just signed a $60 billion deal with China to build a coal mine in Queensland and a 311-mile rail way for transporting the coal to the coast for export to China’s power plants.[xvii]
While China has been slow in adding nuclear power plants, it currently has 20 nuclear reactors under construction and more starting construction this year.[xviii] Four AP 1000 reactors are under construction at 2 different sites: Haiyang and Sanmen.[xix] These are the same reactors that the U.S. Nuclear Regulatory Commission (NRC) has ruled need additional analysis, testing, or design modifications of the shield building to ensure compliance with NRC requirements before they can be constructed in the U.S.[xx] China expects to achieve a total nuclear capacity of 60 gigawatts by 2020, and 120 to 160 gigawatts by 2030,[xxi] surpassing the total nuclear capacity of the United States.
China has a goal to produce 15 percent of its energy from renewables by 2020.[xxii] To help meet this goal, China is planning to build the world’s largest wind farm in the northwest part of the country. The plan is for 5 gigawatts in 2010, expanding to 20 gigawatts in 2020, at a cost of $1 million per megawatt,[xxiii] or $1,000 per kilowatt, about half the cost of an onshore wind unit in the U.S., according to the Energy Information Administration.[xxiv]
What about the U.S.?
The U.S. has made it difficult to build generating plants in this country, particularly coal-fired and nuclear power plants. According to NETL, only eight coal-fired plants totaling 3,218 megawatts became operational in the U.S. in 2009, the largest increase in coal-fired capacity additions in one year since 1991.[xxv] Prospects of cap-and-trade legislation, reviews and re-reviews by the Environmental Protection Agency, direct action protests, petition drives, renewable portfolio standards in many states, competition from wind power, and lawsuits have slowed the construction of new coal-fired plants.[xxvi] As of late February, activists had derailed 97 of the 151 new plants that were in the pipeline in May 2007. According to the Sierra Club, 126 coal plants have been stopped since 2001. And, for the first time in more than 6 years, not one new coal plant broke ground in 2009. The graph above compares the coal-plant additions in the U.S. to that of China, showing only a handful of coal plants under construction in the U.S. With new coal-fired plants extremely limited by the above, some are purporting that the current direction for activists may be to phase out the existing fleet of coal-fired power plants.[xxvii] Because the capital cost of most of our coal-fired plants has been paid, that fleet produces almost 50 percent of our electricity at very little cost. Average production costs for coal-fired generators in 2008 were only 2.75 cents per kilowatt hour, second to our nuclear plants at 1.87 cents per kilowatt hour.[xxviii]
No nuclear plant has started up in the U.S. since 1996,[xxix] and no construction permits have been issued since 1979.[xxx]NRC requirements, financing difficulties, and slow fulfillment of the nuclear provisions of the Energy Policy Act of 2005 have slowed the construction of new nuclear power reactors. However, as part of the 2005 Energy Policy Act, President Obama announced last month that his administration is offering conditional commitments for $8.33 billion in loan guarantees for nuclear power construction and operation. Two new 1,100 megawatt Westinghouse AP1000 nuclear reactors are to be constructed at the Alvin W. Vogtle Electric Generating Plant in Burke, Georgia, supplementing the two reactors already at the site. The two new nuclear generating units are expected to begin commercial operation in 2016 and 2017 at a cost of $14 billion. As part of the conditional loan guarantee deal, the U.S. Nuclear Regulatory Commission must determine if the AP1000 fulfills the regulatory requirements for a construction and operating license.[xxxi] (These are the same units permitted, licensed, and being constructed in China right now.) But, as a recent Wall Street Journal energy conference noted, loan guarantees are “meaningless in the absence of regulatory certainty.” Further, Obama’s budget cutbacks for Yucca Mountain, the proposed nuclear waste repository, are yet another signal that President Obama may not “walk the talk.”[xxxii]
Natural gas and wind power are the technologies that seem best able to surmount the financial, regulatory, and legal hurdles of getting plants permitted and operational. In 2008, the U.S. added over 15,000 megawatts of electric generating capacity, of which 4,556 megawatts was natural gas-fired and 8,136 megawatts was wind power.[xxxiii] However, organized local opposition has halted even some renewable energy projects by using “not in my back yard” (NIMBY) issues, changing zoning laws, opposing permits, filing lawsuits, and bleeding projects of their financing.[xxxiv]
The Energy information Administration projects that the U.S. will need 200 gigawatts of additional generating capacity by 2035 to replace capacity that will be retired and to meet new electricity demand.[xxxv] Of that amount, EIA expects that 13 percent will be coal-fired, 53 percent natural gas-fired, 4 percent will be from nuclear power, and 29 percent from renewable power (23 percent is expected to be wind power), assuming that no changes would be made to current laws and regulations.[xxxvi]
Conclusion
China realizes that it needs affordable energy to fuel its economic growth, and is building all forms of generating technologies at breakneck speed. By contrast, the electric generating construction program in the United States has slowed tremendously, owing to regulatory, financial, and legal problems. Without reasonably priced energy, it will be difficult to achieve high levels of economic growth in the U.S., and industry will move offshore where energy is more affordable. Will Secretary Chu’s policies get us to affordable energy, or will the administration’s policies divert us from obtaining the energy that we need to fuel our economy?
[i] Climate Wire, Energy policy: U.S. clean tech outpaced by China—Chu, March 9, 2010, http://www.eenews.net/climatewire/2010/03/09/3 [ii] Renewable Energy Policy Network for the 21st Century, Renewables Global Status Report 2009 Update, May 13, 2009, http://www.ren21.net/pdf/RE_GSR_2009_Update.pdf
[iii] http://www.seia.org/cs/about_solar_energy/industry_data
[iv] Ibid.
[v] Center for American Progress, Out of the Running, March 2010, http://www.eenews.net/public/25/14571/features/documents/2010/03/04/document_cw_01.pdf
[vi] Global Wind Energy Council, http://www.gwec.net/index.php?id=13, and Global Wind Energy Council, Global wind power boom continues amid economic woes, March 2, 2010, http://www.gwec.net/index.php?id=30&no_cache=1&tx_ttnews[tt_news]=247&tx_ttnews[backPid]=4&cHash=1196e940a0
[vii] American Wind Energy Association, U.S. Wind Energy breaks all records, January 26, 2010, http://www.awea.org/newsroom/releases/01-26-10_AWEA_Q4_and_Year-End_Report_Release.html
[viii] Global Wind Energy Council, Global wind power boom continues amid economic woes, March 2, 2010, http://www.gwec.net/index.php?id=30&no_cache=1&tx_ttnews[tt_news]=247&tx_ttnews[backPid]=4&cHash=1196e940a0
[ix] CNN, U.N. halts funds to China wind farms, December 1, 2010, http://edition.cnn.com/2009/BUSINESS/12/01/un.china.wind.ft/index.html
[x] The Wall Street Journal, “China’s Wind Farms Come with a Catch: Coal Plants”, September 28, 2009, http://online.wsj.com/article/SB125409730711245037.html
[xi] CNN, U.N. halts funds to China wind farms, December 1, 2010, http://edition.cnn.com/2009/BUSINESS/12/01/un.china.wind.ft/index.html
[xii]http://tonto.eia.doe.gov/cfapps/ipdbproject/iedindex3.cfm?tid=2&pid=34&aid=7&cid=r1,&syid=2004&eyid=2008&unit=MK
[xiii] Energy information Administration, International Energy Outlook 2009, http://www.eia.doe.gov/oiaf/ieo/index.html
[xiv] National Energy Technology Laboratory, Tracking New Coal-fired Power Plants, January 8, 2010, http://www.netl.doe.gov/coal/refshelf/ncp.pdf
[xv] http://windfarms.wordpress.com/2009/01/29/china-building-500-coal-plants/
[xvi] The New York Times, “Pollution From Chinese Coal Casts a Global Shadow”, http://www.nytimes.com/2006/06/11/business/worldbusiness/11chinacoal.html?_r=1
[xvii] Australia Signs Huge China Coal Deal, http://windfarms.wordpress.com/2010/02/06/australia-signs-huge-china-coal-deal/
[xviii] Nuclear Power in China”, World Nuclear Association, November 6, 2009, www.world-nuclear.org/info/inf63.html
[xix] Westinghouse News Releases, “Westinghouse and the Shaw Group Celebrate First Concrete Pour at Haiyang Nuclear Site in China”, September 29, 2009, http://westinghousenuclear.mediaroom.com/index.php?s=43&item=200
[xx] Westinghouse Statement Regarding NRC News Release on AP1000 Shield Building, http://westinghousenuclear.mediaroom.com/index.php?s=43&item=203
[xxi] Nuclear Power in China, World Nuclear Association, November 6, 2009, www.world-nuclear.org/info/inf63.html
[xxii] USA Today, “China Pushes Solar, Wind Power Development”, http://www.usatoday.com/money/industries/energy/environment/2009-11-17-chinasolar17_CV_N.htm
[xxiii] The Wall Street Journal, “Wind Power: China’s Massive and Cheap Bet on Wind Farms”, July 6, 2009, http://blogs.wsj.com/environmentalcapital/2009/07/06/wind-power-chinas-massive-and-cheap-bet-on-wind-farms/
[xxiv] Energy information Administration, Assumptions to the Annual Energy Outlook 2009, Table 8.2, Electricity Market Module, http://www.eia.doe.gov/oiaf/aeo/assumption/index.html
[xxv] National Energy Technology Laboratory, Tracking New Coal-fired Power Plants, January 8, 2010, http://www.netl.doe.gov/coal/refshelf/ncp.pdf
[xxvi] A messy but practical strategy for phasing out the U.S. coal fleet, http://www.grist.org/article/death-of-a-thousand-cuts/
[xxvii]Ibid.
[xxviii]http://www.nei.org/resourcesandstats/documentlibrary/reliableandaffordableenergy/graphicsandcharts/uselectricityproductioncosts
[xxix] “Nuclear Power: Outlook for new U.S. Reactors”, Congressional Research Service, March 9, 2007, www.fas.org/sgp/crs/misc/RL33442.pdf
[xxx] Energy Information Administration, Annual Energy Review 2008, Table 9.1, http://www.eia.doe.gov/emeu/aer/pdf/pages/sec9_3.pdf
[xxxi] Environment News Service, Obama Backs First New U.S. Nuclear Plant with $8.3 Billion, February 16, 2010, http://www.ens-newswire.com/ens/feb2010/2010-02-16-091.html
[xxxii] The Wall Street Journal, An Energy Head Fake, March 11,2010, http://online.wsj.com/article/SB10001424052748704784904575112144130306052.html?mod=WSJ_Opinion_AboveLEFTTop
[xxxiii] Energy Information Administration, Electric Power Annual, Tables 1.1 and 1.1.A, http://www.eia.doe.gov/cneaf/electricity/epa/epa_sum.html
[xxxiv] For a repository of stalled and stopped energy projects, see U.S. Chamber of Commerce, “Project No Project Energy-Back On Track”, http://pnp.uschamber.com/
[xxxv] Energy Information Administration, Annual Energy Outlook 2010 Early Release, Table A9, http://www.eia.doe.gov/oiaf/aeo/pdf/appa.pdf
[xxxvi] Ibid.
The United States, meanwhile, has fallen behind.
– U.S. Secretary of Energy, Steven Chu
In an attempt to generate support for implementing a cap on carbon dioxide, Energy Secretary Steven Chu and others paint a very dire picture of the U.S.-vs.-China race for clean energy, implying that China is quickly outstripping us in that race.[i] However, all the facts are not on the table. In both 2008 and 2009, the U.S. added more non-hydroelectric renewable capacity than it added traditional capacity (natural gas, coal, oil, and nuclear).[ii] At the end of 2009, the U.S. ranked first in wind capacity in the world with China’s wind capacity about 30 percent less than the U.S. level. At the end of 2008 (the most recent data available), the U.S. ranked fourth in solar capacity, with only Germany, Spain, and Japan having a larger amount. Where China is outstripping us in domestic construction is in coal-fired, nuclear, and hydroelectric generating technologies. Because of U.S. legal and regulatory red tape, it is much harder to build these energy technologies in the U.S. than in China.
What Does the Capacity Data Show for Wind and Solar Power?
According to the Solar Energy Industries Association, the U.S. ranks fourth in the world in solar capacity with 8,800 megawatts at the end of 2008.[iii] Germany, Spain, and Japan, in that order, had larger amounts of solar power at the end of 2008 than the U.S.[iv] China had just 0.3 megawatts of installed solar PV capacity at the end of 2009[v] or 0.003 percent of the solar capacity of the U.S.
According to the Global Wind Energy Council, the U.S. leads the world in wind generating capacity, with 35.2 gigawatts at the end of 2009; Germany is second with 25.8 gigawatts, and China is third with 25.1 gigawatts.[vi] In 2009, the U.S. installed almost 10 gigawatts of wind capacity, a record,[vii] and China installed 13 gigawatts.[viii]
Why is China Building Wind and Solar Capacity?
China builds wind and solar because ratepayers in other countries are paying them to do so. China has been taking advantage of the Clean Development Mechanism (CDM) under the Kyoto Protocol to obtain funding for its solar and wind power.[ix] Under this program, administered by the United Nations, wealthy countries can contribute funds and get credit for “clean technology” built elsewhere as long as it is additional, that is, as long as that technology would not have been built otherwise. China is the world’s largest beneficiary of the program and has benefited to the point where 30 percent of its wind capacity is not operable because it is not connected to the grid.[x] However, in mid 2009, the U.N. started questioning whether the Chinese CDM program was in fact “additional,” because the U.N. found that China was lowering its subsidies to qualify for the program.[xi] That is, China was reducing its own government’s support in order to get international subsidies.
How Do the U.S. and China Electric Construction Programs Compare?
While China is building non-hydro renewable slightly faster than the United States, overall it is building new electrical generation much, much faster than the United States. The most comparable international database on electric generating capacity is found on the Energy Information Administration (EIA) website.[xii] Comparing the electric generating capacity data by technology type for the two countries, at the end of 2007 (the last year of comparable data), the Chinese had a total of 716 gigawatts of generating capacity, about 280 gigawatts less than the 995 gigawatts of capacity in the U.S.
The U.S. has been building generating capacity at a very slow rate, adding between 8 and 15 gigawatts a year since 2004. The Chinese in contrast, to fuel their bulging economy, have added between 75 and 106 gigawatts a year, from 2004 to 2007. Based on Secretary Chu’s comments, one might think that the additional capacity that China was adding was all non-hydroelectric renewable and nuclear capacity. However, that has not been the case. Between 2004 and 2007, the Chinese have added 226 gigawatts of fossil fuel generating capacity, 40 gigawatts of hydroelectric capacity, 2 gigawatts of nuclear capacity, and only 6 gigawatts of non-hydro renewable capacity.
What are China’s Electric Construction Plans?
Both China’s generating sector and its industrial sector rely heavily on coal, with 79 percent of its electric generation being coal-fired.[xiii] According to the National Energy Technology Laboratory (NETL), from 2004 through 2007, China has been building 30 to 70 gigawatts of coal-fired power a year, and has about 70 gigawatts more under construction. NETL sees China building over 185 gigawatts of coal-fired plants in the future.[xiv] (See figure below.)
While China has been slow in adding nuclear power plants, it currently has 20 nuclear reactors under construction and more starting construction this year.[xviii] Four AP 1000 reactors are under construction at 2 different sites: Haiyang and Sanmen.[xix] These are the same reactors that the U.S. Nuclear Regulatory Commission (NRC) has ruled need additional analysis, testing, or design modifications of the shield building to ensure compliance with NRC requirements before they can be constructed in the U.S.[xx] China expects to achieve a total nuclear capacity of 60 gigawatts by 2020, and 120 to 160 gigawatts by 2030,[xxi] surpassing the total nuclear capacity of the United States.
China has a goal to produce 15 percent of its energy from renewables by 2020.[xxii] To help meet this goal, China is planning to build the world’s largest wind farm in the northwest part of the country. The plan is for 5 gigawatts in 2010, expanding to 20 gigawatts in 2020, at a cost of $1 million per megawatt,[xxiii] or $1,000 per kilowatt, about half the cost of an onshore wind unit in the U.S., according to the Energy Information Administration.[xxiv]
What about the U.S.?
The U.S. has made it difficult to build generating plants in this country, particularly coal-fired and nuclear power plants. According to NETL, only eight coal-fired plants totaling 3,218 megawatts became operational in the U.S. in 2009, the largest increase in coal-fired capacity additions in one year since 1991.[xxv] Prospects of cap-and-trade legislation, reviews and re-reviews by the Environmental Protection Agency, direct action protests, petition drives, renewable portfolio standards in many states, competition from wind power, and lawsuits have slowed the construction of new coal-fired plants.[xxvi] As of late February, activists had derailed 97 of the 151 new plants that were in the pipeline in May 2007. According to the Sierra Club, 126 coal plants have been stopped since 2001. And, for the first time in more than 6 years, not one new coal plant broke ground in 2009. The graph above compares the coal-plant additions in the U.S. to that of China, showing only a handful of coal plants under construction in the U.S. With new coal-fired plants extremely limited by the above, some are purporting that the current direction for activists may be to phase out the existing fleet of coal-fired power plants.[xxvii] Because the capital cost of most of our coal-fired plants has been paid, that fleet produces almost 50 percent of our electricity at very little cost. Average production costs for coal-fired generators in 2008 were only 2.75 cents per kilowatt hour, second to our nuclear plants at 1.87 cents per kilowatt hour.[xxviii]
No nuclear plant has started up in the U.S. since 1996,[xxix] and no construction permits have been issued since 1979.[xxx]NRC requirements, financing difficulties, and slow fulfillment of the nuclear provisions of the Energy Policy Act of 2005 have slowed the construction of new nuclear power reactors. However, as part of the 2005 Energy Policy Act, President Obama announced last month that his administration is offering conditional commitments for $8.33 billion in loan guarantees for nuclear power construction and operation. Two new 1,100 megawatt Westinghouse AP1000 nuclear reactors are to be constructed at the Alvin W. Vogtle Electric Generating Plant in Burke, Georgia, supplementing the two reactors already at the site. The two new nuclear generating units are expected to begin commercial operation in 2016 and 2017 at a cost of $14 billion. As part of the conditional loan guarantee deal, the U.S. Nuclear Regulatory Commission must determine if the AP1000 fulfills the regulatory requirements for a construction and operating license.[xxxi] (These are the same units permitted, licensed, and being constructed in China right now.) But, as a recent Wall Street Journal energy conference noted, loan guarantees are “meaningless in the absence of regulatory certainty.” Further, Obama’s budget cutbacks for Yucca Mountain, the proposed nuclear waste repository, are yet another signal that President Obama may not “walk the talk.”[xxxii]
Natural gas and wind power are the technologies that seem best able to surmount the financial, regulatory, and legal hurdles of getting plants permitted and operational. In 2008, the U.S. added over 15,000 megawatts of electric generating capacity, of which 4,556 megawatts was natural gas-fired and 8,136 megawatts was wind power.[xxxiii] However, organized local opposition has halted even some renewable energy projects by using “not in my back yard” (NIMBY) issues, changing zoning laws, opposing permits, filing lawsuits, and bleeding projects of their financing.[xxxiv]
The Energy information Administration projects that the U.S. will need 200 gigawatts of additional generating capacity by 2035 to replace capacity that will be retired and to meet new electricity demand.[xxxv] Of that amount, EIA expects that 13 percent will be coal-fired, 53 percent natural gas-fired, 4 percent will be from nuclear power, and 29 percent from renewable power (23 percent is expected to be wind power), assuming that no changes would be made to current laws and regulations.[xxxvi]
Conclusion
China realizes that it needs affordable energy to fuel its economic growth, and is building all forms of generating technologies at breakneck speed. By contrast, the electric generating construction program in the United States has slowed tremendously, owing to regulatory, financial, and legal problems. Without reasonably priced energy, it will be difficult to achieve high levels of economic growth in the U.S., and industry will move offshore where energy is more affordable. Will Secretary Chu’s policies get us to affordable energy, or will the administration’s policies divert us from obtaining the energy that we need to fuel our economy?
[i] Climate Wire, Energy policy: U.S. clean tech outpaced by China—Chu, March 9, 2010, http://www.eenews.net/climatewire/2010/03/09/3 [ii] Renewable Energy Policy Network for the 21st Century, Renewables Global Status Report 2009 Update, May 13, 2009, http://www.ren21.net/pdf/RE_GSR_2009_Update.pdf
[iii] http://www.seia.org/cs/about_solar_energy/industry_data
[iv] Ibid.
[v] Center for American Progress, Out of the Running, March 2010, http://www.eenews.net/public/25/14571/features/documents/2010/03/04/document_cw_01.pdf
[vi] Global Wind Energy Council, http://www.gwec.net/index.php?id=13, and Global Wind Energy Council, Global wind power boom continues amid economic woes, March 2, 2010, http://www.gwec.net/index.php?id=30&no_cache=1&tx_ttnews[tt_news]=247&tx_ttnews[backPid]=4&cHash=1196e940a0
[vii] American Wind Energy Association, U.S. Wind Energy breaks all records, January 26, 2010, http://www.awea.org/newsroom/releases/01-26-10_AWEA_Q4_and_Year-End_Report_Release.html
[viii] Global Wind Energy Council, Global wind power boom continues amid economic woes, March 2, 2010, http://www.gwec.net/index.php?id=30&no_cache=1&tx_ttnews[tt_news]=247&tx_ttnews[backPid]=4&cHash=1196e940a0
[ix] CNN, U.N. halts funds to China wind farms, December 1, 2010, http://edition.cnn.com/2009/BUSINESS/12/01/un.china.wind.ft/index.html
[x] The Wall Street Journal, “China’s Wind Farms Come with a Catch: Coal Plants”, September 28, 2009, http://online.wsj.com/article/SB125409730711245037.html
[xi] CNN, U.N. halts funds to China wind farms, December 1, 2010, http://edition.cnn.com/2009/BUSINESS/12/01/un.china.wind.ft/index.html
[xii]http://tonto.eia.doe.gov/cfapps/ipdbproject/iedindex3.cfm?tid=2&pid=34&aid=7&cid=r1,&syid=2004&eyid=2008&unit=MK
[xiii] Energy information Administration, International Energy Outlook 2009, http://www.eia.doe.gov/oiaf/ieo/index.html
[xiv] National Energy Technology Laboratory, Tracking New Coal-fired Power Plants, January 8, 2010, http://www.netl.doe.gov/coal/refshelf/ncp.pdf
[xv] http://windfarms.wordpress.com/2009/01/29/china-building-500-coal-plants/
[xvi] The New York Times, “Pollution From Chinese Coal Casts a Global Shadow”, http://www.nytimes.com/2006/06/11/business/worldbusiness/11chinacoal.html?_r=1
[xvii] Australia Signs Huge China Coal Deal, http://windfarms.wordpress.com/2010/02/06/australia-signs-huge-china-coal-deal/
[xviii] Nuclear Power in China”, World Nuclear Association, November 6, 2009, www.world-nuclear.org/info/inf63.html
[xix] Westinghouse News Releases, “Westinghouse and the Shaw Group Celebrate First Concrete Pour at Haiyang Nuclear Site in China”, September 29, 2009, http://westinghousenuclear.mediaroom.com/index.php?s=43&item=200
[xx] Westinghouse Statement Regarding NRC News Release on AP1000 Shield Building, http://westinghousenuclear.mediaroom.com/index.php?s=43&item=203
[xxi] Nuclear Power in China, World Nuclear Association, November 6, 2009, www.world-nuclear.org/info/inf63.html
[xxii] USA Today, “China Pushes Solar, Wind Power Development”, http://www.usatoday.com/money/industries/energy/environment/2009-11-17-chinasolar17_CV_N.htm
[xxiii] The Wall Street Journal, “Wind Power: China’s Massive and Cheap Bet on Wind Farms”, July 6, 2009, http://blogs.wsj.com/environmentalcapital/2009/07/06/wind-power-chinas-massive-and-cheap-bet-on-wind-farms/
[xxiv] Energy information Administration, Assumptions to the Annual Energy Outlook 2009, Table 8.2, Electricity Market Module, http://www.eia.doe.gov/oiaf/aeo/assumption/index.html
[xxv] National Energy Technology Laboratory, Tracking New Coal-fired Power Plants, January 8, 2010, http://www.netl.doe.gov/coal/refshelf/ncp.pdf
[xxvi] A messy but practical strategy for phasing out the U.S. coal fleet, http://www.grist.org/article/death-of-a-thousand-cuts/
[xxvii]Ibid.
[xxviii]http://www.nei.org/resourcesandstats/documentlibrary/reliableandaffordableenergy/graphicsandcharts/uselectricityproductioncosts
[xxix] “Nuclear Power: Outlook for new U.S. Reactors”, Congressional Research Service, March 9, 2007, www.fas.org/sgp/crs/misc/RL33442.pdf
[xxx] Energy Information Administration, Annual Energy Review 2008, Table 9.1, http://www.eia.doe.gov/emeu/aer/pdf/pages/sec9_3.pdf
[xxxi] Environment News Service, Obama Backs First New U.S. Nuclear Plant with $8.3 Billion, February 16, 2010, http://www.ens-newswire.com/ens/feb2010/2010-02-16-091.html
[xxxii] The Wall Street Journal, An Energy Head Fake, March 11,2010, http://online.wsj.com/article/SB10001424052748704784904575112144130306052.html?mod=WSJ_Opinion_AboveLEFTTop
[xxxiii] Energy Information Administration, Electric Power Annual, Tables 1.1 and 1.1.A, http://www.eia.doe.gov/cneaf/electricity/epa/epa_sum.html
[xxxiv] For a repository of stalled and stopped energy projects, see U.S. Chamber of Commerce, “Project No Project Energy-Back On Track”, http://pnp.uschamber.com/
[xxxv] Energy Information Administration, Annual Energy Outlook 2010 Early Release, Table A9, http://www.eia.doe.gov/oiaf/aeo/pdf/appa.pdf
[xxxvi] Ibid.
Monday, February 8, 2010
GMO Panel deliberations on the paper by de Vendômois et al. (2009, A Comparison of the Effects of Three GM Corn Varieties on Mammalian Health, International Journal of Biological Sciences, 5: 706-726)
EFSA: Adopted part of the minutes of the 55th plenary meeting of the Scientific Panel on Genetically Modified Organisms held on 27-28 January 2010 to be published at http://www.efsa.europa.eu/en/events/event/gmo100127.htm
GMO Panel deliberations on the paper by de Vendômois et al. (2009, A Comparison of the Effects of Three GM Corn Varieties on Mammalian Health, International Journal of Biological Sciences, 5: 706-726)
The EFSA GMO Panel has considered the paper by de Vendômois et al. (2009, A Comparison of the Effects of Three GM Corn Varieties on Mammalian Health, International Journal of Biological Sciences, 5: 706-726), a statistical reanalysis of data from three 90-day rat feeding studies already assessed by the GMO Panel (EFSA, 2003a,b; EFSA 2004a,b; EFSA 2009b,c). The GMO Panel concludes that the authors’ claims, regarding new side effects indicating kidney and liver toxicity, are not supported by the data provided in their paper. There is no new information that would lead it to reconsider its previous opinions on the three maize events MON810, MON863 and NK603, which concluded that there were no indications of adverse effects for human, animal health and the environment.
The GMO Panel notes that several of its fundamental statistical criticisms (EFSA, 2007a,b) of the authors' earlier study (Seralini et al., 2007) of maize MON863 are also applicable to the new paper by de Vendômois et al. In the GMO Panel's extensive evaluation of Seralini et al. (2007), reasons for the apparent excess of significant differences found for MON863 (8%) were given and it was shown that this raised no safety concerns. The percentage of variables tested reported by de Vendômois et al. that were significant for NK603 (9%) and MON810 (6%) were of similar magnitude to that for MON863.
The GMO Panel considers that de Vendômois et al.: (1) make erroneous statements concerning the use of reference varieties to provide estimates of variability that allow equivalence testing to place statistically significant results into biological context as advocated by EFSA (2008, 2009a); (2) do not use the available information concerning normal background variability between animals fed with different diets, to place observed differences into biological context; (3) do not present results using their False Discovery Rate methodology in a meaningful way; (4) give no evidence to relate wellknown gender differences in response to diet to claims of effects due to the respective GMOs; (5) estimate statistical power based on inappropriate analyses and magnitudes of difference.
The significant differences highlighted by de Vendômois et al. have all been considered previously by the GMO Panel in its previous opinions on the three maize events MON810, MON863 and NK603. The study by de Vendômois et al. provides no new evidence of toxic effects. The approach used by de Vendômois et al. does not allow a proper assessment of the differences claimed between the GMOs and their respective counterparts for their toxicological relevance because: (1) results are presented exclusively in the form of percentage differences for each variable, rather than in their actual measured units; (2) the calculated values of the toxicological parameters tested are not related to the normal range for the species concerned; (3) the calculated values of the toxicological parameters tested are not compared with ranges of variation found in test animals fed with diets containing different reference varieties; (4) the statistically significant differences did not show consistency patterns over endpoint variables and doses; (5) the inconsistencies between the purely statistical arguments of de Vendômois et al., and the results for these three animal feeding studies which relate to organ pathology, histopathology and histochemistry, are not addressed. Regarding claims made by de Vendômois et al. concerning the inadequacy of the experimental design of these three animal feeding studies, the GMO Panel notes that they were all carried out to agreed internationally-defined standards consistent with OECD protocols.
References
- EFSA, 2003a. Opinion of the Scientific Panel on genetically modified organisms (GMO) on a request from the Commission related to the safety of foods and food ingredients derived from herbicidetolerant genetically modified maize NK603, for which a request for placing on the market was submitted under Article 4 of the Novel Food Regulation (EC) No 258/97 by Monsanto. http://www.efsa.europa.eu/en/scdocs/scdoc/9.htm
- EFSA, 2003b. Opinion of the Scientific Panel on genetically modified organisms (GMO) on a request from the Commission related to the Notification (Reference CE/ES/00/01) for the placing on the market of herbicide-tolerant genetically modified maize NK603, for import and processing, under Part C of Directive 2001/18/EC from Monsanto. http://www.efsa.europa.eu/en/scdocs/scdoc/10.htm
- EFSA, 2004a. Opinion of the Scientific Panel on genetically modified organisms (GMO) on a request from the Commission related to the Notification (Reference C/DE/02/9) for the placing on the market of insect-protected genetically modified maize MON 863 and MON 863 x MON 810, for import and processing, under Part C of Directive 2001/18/EC from Monsanto. http://www.efsa.europa.eu/en/scdocs/scdoc/49.htm
- EFSA, 2004b. Opinion of the Scientific Panel on genetically modified organisms (GMO) on a request from the Commission related to the safety of foods and food ingredients derived from insectprotected genetically modified maize MON 863 and MON 863 x MON 810, for which a request for placing on the market was submitted under Article 4 of the Novel Food Regulation (EC) No 258/97 by Monsanto. http://www.efsa.europa.eu/en/scdocs/scdoc/50.htm
- EFSA, 2007a. EFSA review of statistical analyses conducted for the assessment of the MON 863 90- day rat feeding study. http://www.efsa.europa.eu/en/scdocs/scdoc/19r.htm EFSA, 2007b. Statement on the analysis of data from a 90-day rat feeding study with MON 863 maize by the Scientific Panel on genetically modified organisms (GMO). http://www.efsa.europa.eu/en/scdocs/scdoc/753.htm
- EFSA, 2008. Updated guidance document for the risk assessment of genetically modified plants and derived food and feed. Annex A. http://www.efsa.europa.eu/en/scdocs/scdoc/293r.htm EFSA, 2009a. Statistical considerations for the safety evaluation of GMOs. http://www.efsa.europa.eu/en/scdocs/scdoc/1250.htm
- EFSA, 2009b. Applications (references EFSA-GMO-NL-2005-22, EFSA-GMO-RX-NK603) for the placing on the market of the genetically modified glyphosate tolerant maize NK603 for cultivation, food and feed uses, import and processing and for renewal of the authorisation of maize NK603 as existing products, both under Regulation (EC) No 1829/2003 from Monsanto. http://www.efsa.europa.eu/en/scdocs/scdoc/1137.htm
- EFSA, 2009c. Applications (EFSA-GMO-RX-MON810) for renewal of authorisation for the continued marketing of (1) existing food and food ingredients produced from genetically modified insect resistant maize MON810; (2) feed consisting of and/or containing maize MON810, including the use of seed for cultivation; and of (3) food and feed additives, and feed materials produced from maize MON810, all under Regulation (EC) No 1829/2003 from Monsanto. http://www.efsa.europa.eu/en/scdocs/scdoc/1149.htm
- Seralini, G.E., Cellier D., de Vendômois J.S. 2007. New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity. Arch. Environ. Contam. Toxicol., 52: 596-602.
GMO Panel deliberations on the paper by de Vendômois et al. (2009, A Comparison of the Effects of Three GM Corn Varieties on Mammalian Health, International Journal of Biological Sciences, 5: 706-726)
The EFSA GMO Panel has considered the paper by de Vendômois et al. (2009, A Comparison of the Effects of Three GM Corn Varieties on Mammalian Health, International Journal of Biological Sciences, 5: 706-726), a statistical reanalysis of data from three 90-day rat feeding studies already assessed by the GMO Panel (EFSA, 2003a,b; EFSA 2004a,b; EFSA 2009b,c). The GMO Panel concludes that the authors’ claims, regarding new side effects indicating kidney and liver toxicity, are not supported by the data provided in their paper. There is no new information that would lead it to reconsider its previous opinions on the three maize events MON810, MON863 and NK603, which concluded that there were no indications of adverse effects for human, animal health and the environment.
The GMO Panel notes that several of its fundamental statistical criticisms (EFSA, 2007a,b) of the authors' earlier study (Seralini et al., 2007) of maize MON863 are also applicable to the new paper by de Vendômois et al. In the GMO Panel's extensive evaluation of Seralini et al. (2007), reasons for the apparent excess of significant differences found for MON863 (8%) were given and it was shown that this raised no safety concerns. The percentage of variables tested reported by de Vendômois et al. that were significant for NK603 (9%) and MON810 (6%) were of similar magnitude to that for MON863.
The GMO Panel considers that de Vendômois et al.: (1) make erroneous statements concerning the use of reference varieties to provide estimates of variability that allow equivalence testing to place statistically significant results into biological context as advocated by EFSA (2008, 2009a); (2) do not use the available information concerning normal background variability between animals fed with different diets, to place observed differences into biological context; (3) do not present results using their False Discovery Rate methodology in a meaningful way; (4) give no evidence to relate wellknown gender differences in response to diet to claims of effects due to the respective GMOs; (5) estimate statistical power based on inappropriate analyses and magnitudes of difference.
The significant differences highlighted by de Vendômois et al. have all been considered previously by the GMO Panel in its previous opinions on the three maize events MON810, MON863 and NK603. The study by de Vendômois et al. provides no new evidence of toxic effects. The approach used by de Vendômois et al. does not allow a proper assessment of the differences claimed between the GMOs and their respective counterparts for their toxicological relevance because: (1) results are presented exclusively in the form of percentage differences for each variable, rather than in their actual measured units; (2) the calculated values of the toxicological parameters tested are not related to the normal range for the species concerned; (3) the calculated values of the toxicological parameters tested are not compared with ranges of variation found in test animals fed with diets containing different reference varieties; (4) the statistically significant differences did not show consistency patterns over endpoint variables and doses; (5) the inconsistencies between the purely statistical arguments of de Vendômois et al., and the results for these three animal feeding studies which relate to organ pathology, histopathology and histochemistry, are not addressed. Regarding claims made by de Vendômois et al. concerning the inadequacy of the experimental design of these three animal feeding studies, the GMO Panel notes that they were all carried out to agreed internationally-defined standards consistent with OECD protocols.
References
- EFSA, 2003a. Opinion of the Scientific Panel on genetically modified organisms (GMO) on a request from the Commission related to the safety of foods and food ingredients derived from herbicidetolerant genetically modified maize NK603, for which a request for placing on the market was submitted under Article 4 of the Novel Food Regulation (EC) No 258/97 by Monsanto. http://www.efsa.europa.eu/en/scdocs/scdoc/9.htm
- EFSA, 2003b. Opinion of the Scientific Panel on genetically modified organisms (GMO) on a request from the Commission related to the Notification (Reference CE/ES/00/01) for the placing on the market of herbicide-tolerant genetically modified maize NK603, for import and processing, under Part C of Directive 2001/18/EC from Monsanto. http://www.efsa.europa.eu/en/scdocs/scdoc/10.htm
- EFSA, 2004a. Opinion of the Scientific Panel on genetically modified organisms (GMO) on a request from the Commission related to the Notification (Reference C/DE/02/9) for the placing on the market of insect-protected genetically modified maize MON 863 and MON 863 x MON 810, for import and processing, under Part C of Directive 2001/18/EC from Monsanto. http://www.efsa.europa.eu/en/scdocs/scdoc/49.htm
- EFSA, 2004b. Opinion of the Scientific Panel on genetically modified organisms (GMO) on a request from the Commission related to the safety of foods and food ingredients derived from insectprotected genetically modified maize MON 863 and MON 863 x MON 810, for which a request for placing on the market was submitted under Article 4 of the Novel Food Regulation (EC) No 258/97 by Monsanto. http://www.efsa.europa.eu/en/scdocs/scdoc/50.htm
- EFSA, 2007a. EFSA review of statistical analyses conducted for the assessment of the MON 863 90- day rat feeding study. http://www.efsa.europa.eu/en/scdocs/scdoc/19r.htm EFSA, 2007b. Statement on the analysis of data from a 90-day rat feeding study with MON 863 maize by the Scientific Panel on genetically modified organisms (GMO). http://www.efsa.europa.eu/en/scdocs/scdoc/753.htm
- EFSA, 2008. Updated guidance document for the risk assessment of genetically modified plants and derived food and feed. Annex A. http://www.efsa.europa.eu/en/scdocs/scdoc/293r.htm EFSA, 2009a. Statistical considerations for the safety evaluation of GMOs. http://www.efsa.europa.eu/en/scdocs/scdoc/1250.htm
- EFSA, 2009b. Applications (references EFSA-GMO-NL-2005-22, EFSA-GMO-RX-NK603) for the placing on the market of the genetically modified glyphosate tolerant maize NK603 for cultivation, food and feed uses, import and processing and for renewal of the authorisation of maize NK603 as existing products, both under Regulation (EC) No 1829/2003 from Monsanto. http://www.efsa.europa.eu/en/scdocs/scdoc/1137.htm
- EFSA, 2009c. Applications (EFSA-GMO-RX-MON810) for renewal of authorisation for the continued marketing of (1) existing food and food ingredients produced from genetically modified insect resistant maize MON810; (2) feed consisting of and/or containing maize MON810, including the use of seed for cultivation; and of (3) food and feed additives, and feed materials produced from maize MON810, all under Regulation (EC) No 1829/2003 from Monsanto. http://www.efsa.europa.eu/en/scdocs/scdoc/1149.htm
- Seralini, G.E., Cellier D., de Vendômois J.S. 2007. New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity. Arch. Environ. Contam. Toxicol., 52: 596-602.
Saturday, January 16, 2010
FDA Decision on Chemical BPA Gets Mixed Review: "ACSH scientists are glad a ban was avoided but remain disappointed"
FDA Decision on Chemical BPA Gets Mixed Review: "ACSH scientists are glad a ban was avoided but remain disappointed."
ACSH, January 15, 2010
New York NY -- January 15th, 2010. The American Council on Science and Health applauds today's decision by the Food and Drug Administration (FDA) not to ban the plastic hardener bisphenol-A (BPA). Despite heavy pressure from various activist "environmental" groups, the FDA has not placed any restrictions on the chemical's use in consumer products but rather decided to "support" industry's decisions to reduce exposure to BPA in food-related products aimed at infants and children. FDA is also "facilitating" the development of alternatives to BPA in infant formula cans.
FDA stopped well short of a ban on this common and useful chemical, which has been in safe use in a wide spectrum of consumer products for over 50 years. ACSH scientists are pleased but remain disappointed that the FDA review and recommendations deviated at all from sound science -- by showing concern for hypothetical and non-existent health risks. ACSH's medical director, Dr. Gilbert Ross, said: "BPA has been among the most well-studied substances known to man, and repeated evaluation by respected scientific bodies worldwide has without fail deemed BPA safe as typically used. Our publication on BPA remains quite relevant today: we found that BPA is safe for all ages, including infants and children."
Another key fact is that since BPA became commonplace in the lining of canned goods, foodborne illness from canned foods -- including botulism -- has virtually disappeared. Any possible new replacement could not have the same record of testing and safety as has been shown for BPA.
ACSH's president, Dr. Elizabeth M. Whelan, added, "The fear campaign against BPA promoted by a few activist groups has been based solely on flimsy animal research. Recently, lacking real science to support their alarmist claims, some labs have tried 'novel approaches to test for subtle effects,' as the FDA report states. This is not how human risk assessment should be carried out. If there were any real adverse health effects from exposure to BPA, such effects would have become manifest long ago and would not have required bizarre tests in a few advocate's labs."
ACSH's associate director, Jeff Stier, pointed out: "This finding should put the matter to rest. The current FDA is very cautionary. After taking all this extra time to re-study the issue, the fact that they are keeping BPA on the market speaks volumes about the safety of the product. If BPA were endangering children, they'd have never left it on the market."
See also: ACSH's earlier official statement on The Facts About Bisphenol A.
For media contact, including interviews, please call:
Dr. Elizabeth Whelan (WhelanE[at]ACSH.org): 917-439-8043
Dr. Gilbert Ross (RossG[at]ACSH.org): 516-581-8400
Jeff Stier (StierJ[at]ACSH.org): 646-245-1443
ACSH, January 15, 2010
New York NY -- January 15th, 2010. The American Council on Science and Health applauds today's decision by the Food and Drug Administration (FDA) not to ban the plastic hardener bisphenol-A (BPA). Despite heavy pressure from various activist "environmental" groups, the FDA has not placed any restrictions on the chemical's use in consumer products but rather decided to "support" industry's decisions to reduce exposure to BPA in food-related products aimed at infants and children. FDA is also "facilitating" the development of alternatives to BPA in infant formula cans.
FDA stopped well short of a ban on this common and useful chemical, which has been in safe use in a wide spectrum of consumer products for over 50 years. ACSH scientists are pleased but remain disappointed that the FDA review and recommendations deviated at all from sound science -- by showing concern for hypothetical and non-existent health risks. ACSH's medical director, Dr. Gilbert Ross, said: "BPA has been among the most well-studied substances known to man, and repeated evaluation by respected scientific bodies worldwide has without fail deemed BPA safe as typically used. Our publication on BPA remains quite relevant today: we found that BPA is safe for all ages, including infants and children."
Another key fact is that since BPA became commonplace in the lining of canned goods, foodborne illness from canned foods -- including botulism -- has virtually disappeared. Any possible new replacement could not have the same record of testing and safety as has been shown for BPA.
ACSH's president, Dr. Elizabeth M. Whelan, added, "The fear campaign against BPA promoted by a few activist groups has been based solely on flimsy animal research. Recently, lacking real science to support their alarmist claims, some labs have tried 'novel approaches to test for subtle effects,' as the FDA report states. This is not how human risk assessment should be carried out. If there were any real adverse health effects from exposure to BPA, such effects would have become manifest long ago and would not have required bizarre tests in a few advocate's labs."
ACSH's associate director, Jeff Stier, pointed out: "This finding should put the matter to rest. The current FDA is very cautionary. After taking all this extra time to re-study the issue, the fact that they are keeping BPA on the market speaks volumes about the safety of the product. If BPA were endangering children, they'd have never left it on the market."
See also: ACSH's earlier official statement on The Facts About Bisphenol A.
For media contact, including interviews, please call:
Dr. Elizabeth Whelan (WhelanE[at]ACSH.org): 917-439-8043
Dr. Gilbert Ross (RossG[at]ACSH.org): 516-581-8400
Jeff Stier (StierJ[at]ACSH.org): 646-245-1443
Friday, January 15, 2010
Monsanto Response: de Vendomois (Seralini) et al. 2009
Monsanto Response: de Vendomois (Seralini) et al. 2009.
(A Comparison of the Effects of Three GM Corn Varieties on Mammalian Health)
Regarding: MON 863, MON 810 and NK603
(A Comparison of the Effects of Three GM Corn Varieties on Mammalian Health)
Regarding: MON 863, MON 810 and NK603
Assessment of Quality and Response to Technical Issues
Synopsis:
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The laboratory findings primarily related to kidney and liver function reflect the large proportion of tests applicable to these organ systems. This is not a defect in the design of the study, but simply the reality of biochemical testing - there are good clinical tests of these systems which are reflected in blood chemistry. The function of other organ systems is assessed primarily via functional assessment, organ weight, and organ pathology rather than through blood or urine biochemical assays.
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The authors apply a variety of non-standard statistical approaches. Each unique statistical approach and each comparison performed increases the number of statistically significant findings which will occur by chance alone. Thus, the fact that de Vendomois et al. find more statistically significant findings than reported in the Monsanto analysis is entirely expected. The question, which de Vendomois et al. fail to address, is whether these non-routine statistical tests contribute anything of value to a safety assessment. Do they help to ascertain whether there are biologically and toxicologically significant events? In our opinion (consistent with prior reviews of other publications from Seralini and colleagues) they do not.
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The authors undertake a complex “principle component analysis” to demonstrate that kidney and liver function tests vary between male and female rodents. This phenomenon is well-recognized in rodents (and, for that matter, humans) as a matter of gender difference. (This does not indicate any toxic effect, and is not claimed to do so by the authors, but may be confusing to those not familiar with the method and background.)
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De Vendomois et al. appear to draw from this a conclusion that there is a gender difference in susceptibility to toxic effects. While such differences are possible, no difference in susceptibility can be demonstrated by gender differences in normal baseline values. Utilizing this alleged difference in gender susceptibility, the authors proceed to identify statistically significant, but biologically meaningless differences (see next bullet) and to evaluate the extent to which these changes occur in males verses females.
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De Vendomois et al. fail to consider whether a result is biologically meaningful, based on the magnitude of the difference observed, whether the observation falls outside of the normal range for the species, whether the observation falls outside the range observed in various reference materials, whether there is evidence of a dose-response, and whether there is consistency between sexes and consistency among tested GM materials. These failures are similar to those observed in previous publications by the same group of authors.
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While the number of tests that are statistically significant in males verses females would ON AVERAGE be equal in a random distribution, this ratio will fluctuate statistically. The authors have not, in fact, demonstrated any consistent susceptibility between genders, nor have they demonstrated that the deviations from equality in regards to numbers of positive tests fall outside of expectation. For example, if you flip a coin 10 times, on average you will get 50% heads and 50% tails but it is not unusual to get 7 heads and 3 tails on a particular 10 tosses. If you do this over and over and consistently get on average 7 heads and 3 tails then there may be something different about the coin that is causing this unexpected result. However, de Vendomois et al. have not shown any such consistent difference.
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While de Vendomois et al. criticize the lack of testing for cytochrome P450, such testing is not routinely a part of any toxicity testing protocol. These enzymes are responsible for (among other things) the metabolism of chemicals from the environment, and respond to a wide variety of external stimuli as a part of their normal function. There is no rational reason to test for levels of cytochromes in this type of testing, as they do not predict pathology. De Vendomois et al. could have identified thousands of different elements, enzymes and proteins that were not measured but this does not indicate a deficiency in the study design since there is no logical basis for testing them.
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While de Vendomois et al. criticize the occurrence of missing laboratory values, the vast majority of missing values are accounted for by missing urine specimens (which may or may not be obtainable at necropsy) or by a small number of animals found in a deceased condition (which are not analyzed due to post-mortem changes). Overall, despite the challenges in carrying out such analyses on large numbers of animals, almost 99% of values were reported.
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The statistical power analysis done by de Vendomois et al. is invalid, as it is based upon non-relevant degrees of difference and upon separate statistical tests rather than the ANOVA technique used by Monsanto (and generally preferred). The number of animals used is consistent with generally applicable designs for toxicology studies.
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Prior publications by Seralini and colleagues in both the pesticide and GM crops arenas have been found wanting in both scientific methodology and credibility by numerous regulatory agencies and independent scientific panels (as detailed below).
-
In the press release associated with this publication, the authors denounce the various regulatory and scientific bodies which have criticized prior work, and claim, in advance, that these agencies and individuals suffer from incompetency and/or conflict of interest. In effect, the authors claim that their current publication cannot be legitimately criticized by anyone who disagrees with their overall opinions, past or present.
To summarize, as with the prior publication of Seralini et al. (2007), de Vendomois et al. (2009) uses non-traditional and inappropriate statistical methods to reach unsubstantiated conclusions in a reassessment of toxicology data from studies conducted with MON 863, MON 810 and NK603. Not surprisingly, they assert that they have found evidence for safety concerns with these crops but these claims are based on faulty analytical methods and reasoning and do not call into question the safety findings for these products.
Response to de Vendomois et al. 2009:
In the recent publication “A comparison of the effects of three GM corn varieties on mammalian health”, (de Vendomois et al., 2009), the authors claim to have found evidence of hepatorenal toxicity through reanalysis of the data from toxicology studies with three biotechnology-derived corn products (MON 863, MON 810 and NK603).
This theme of hepatorenal toxicity was raised in a previous publication on MON 863 by the same authors (Seralini et al., 2007). Scientists who reviewed the 2007 publication did not support that paper’s conclusions on MON 863 and the review addressed many deficiencies in the statistical reanalysis (Doull et al., 2007; EFSA, 2007a; EFSA, 2007b; Bfr, 2007; AFFSA, 2007, Monod, 2007, FSANZ, 2007). These reviews of the 2007 paper confirmed that the original analysis of the data by various regulatory agencies was correct and that MON 863 grain is safe for consumption based on the weight of evidence that includes a 90-day rat feeding study.
De Vendomois et al., (2009) elected to ignore the aforementioned expert scientific reviews by global authorities and regulatory agencies and again have used non-standard and inappropriate methods to reanalyze toxicology studies with MON 863, MON 810 and NK603. This is despite more than 10 years of safe cultivation and consumption of crops developed through modern biotechnology that have also completed extensive safety assessment and review by worldwide regulatory agencies, in each case reaching a conclusion that these products are safe.
General Comments:
De Vendomois et al. (2009) raise a number of general criticisms of the Monsanto studies that are worthy of mention before commenting on the analytical approach used by de Vendomois et al. and pointing out a number of examples where the application of their approach leads to misinterpretation of the data.
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Testing for cytochrome P450 levels is not a part of any standard toxicology study, nor do changes in P450 levels per-se indicate organ pathology, as the normal function of these enzymes is to respond to the environment. Testing of cytochrome P450 levels is not part of any recognized standard for laboratory testing.
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De Vendomois et al. note that the “effects” assessed by laboratory analysis were “mostly associated with the kidney and liver”. However, a review of the laboratory tests (annex 1 of paper), ignoring weight parameters, will indicate that measures of liver and kidney function are disproportionately represented among the laboratory tests. Urinary electrolytes are also particularly variable (see below). The apparent predominance of statistical differences in liver and kidney parameters is readily explained by the testing performed.
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As noted by the authors, findings are largely within the normal range for parameters even if statistically significant, are inconsistent among GM crops, and are inconsistent between sexes. Despite this, and the lack of associated illness or organ pathology, the authors choose to interpret small random variations typically seen in studies of this type as evidence of potential toxicity.
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The authors criticize the number of missing laboratory data, and indicate that the absence of values is not adequately explained. We would note that the bulk of missing values relate to urinalysis. The ability to analyze urine depends upon the availability of sufficient quantities of urine in the bladder at the time of necropsy, and thus urine specimens are often missing in any rodent study. Organ weights and other studies are generally not measured on animals found deceased (due to post-mortem changes the values are not considered valid). Each study consisted of 200 animals, or 800 possible data collections (counting urine, hematology, or organ weights + blood chemistry as one “type” as in the paper).
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NK 603- of 600 possible data determinations, 28 values were missing. 20 were due to missing urines and 2 were missing weights and biochemical analysis due to animals found dead (1 GM, 1 reference). Of the remaining 6 values (hematology), only 1 value is from the GM-fed group.
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MON 810- Of 600 possible determinations, 24 values were missing. 18 were due to missing urines and 1 value was missing (weight and biochemical analysis) due to an animal found dead (reference group). Of the remaining 5 values (hematology), 2 are from the GM-fed group and 3 from various reference groups.
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MON 863- Of 600 possible determinations, 25 values were missing. 13 were due to missing urines. 9 hematology analyses (3 GMO-fed) and 3 organ weight/biochemical analyses due to deaths (1 GMO) were reported as missing (not deceased).
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These are large and complex studies. Ignoring urines and the small number of animals found deceased (which occurs in any large study), 20 data sets (17 hematology, 3 organ weights/chemistry) are missing from a possible 1800 sets, i.e.- almost 99% of data were present, despite the technical difficulties inherent in handling large numbers of animals.
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- The “findings” in this study are stated to be due to “either the recognized mutagenic effects of the GM transformation process or to the presence of… novel pesticides.” We would note that there is no evidence for “mutagenic effect” other than stable gene insertion in the tested products. We would also note that while the glyphosate tolerant crop (NK603) may indeed have glyphosate residues present, this is not a “novel” pesticide residue. The toxicity of glyphosate has been extensively evaluated, and the “effects” with NK603 cannot be explained on this basis. Similarly, other available data regarding the Bt insecticidal proteins in MON 810 and MON 863 do not support the occurrence of toxic effects due to these agents.
Statistical Analysis Approach:
De Vendomois et al., (2009) used a flawed basis for risk assessment, focusing only on statistical manipulation of data (sometimes using questionable methods) and ignoring consideration of other relevant biological information. By focusing only on statistical manipulations, the authors found more statistically significant differences for the data than was previously reported and claimed that this is new evidence for adverse effects. As is well documented in toxicology textbooks (e.g., Casarett and Doull, Toxicology, The Basic Science of Poisons, Klaassen Ed., The McGraw-Hill Companies, 2008, Chapter 2) and other resources mentioned below, interpretation of study findings involves more than statistical manipulations, one has to consider data in the context of the biology of the animal. This subject was addressed by a peer review panel of internationally recognized toxicologists and statisticians who reviewed the Seralini et al., (2007) publication. They state in Doull et al. (2007)
“The Panel concludes that the Seralini et al. (2007) reanalysis provided no evidence to indicate that MON 863 was associated with any adverse effects in the 90-day rat study (Covance, 2002; Hammond et al., 2006). In each case the statistical findings reported by both Monsanto (Covance, 2002; Hammond et al., 2006) or Seralini et al. (2007) were considered to be unrelated to treatment or of no biological or clinical importance because they failed to demonstrate a dose–response relationship, reproducibility over time, association with other relevant changes (e.g., histopathology), occurrence in both sexes, difference outside the normal range of variation, or biological plausibility with respect to cause-and-effect”
There are numerous ways to analyze biological data and a multitude of statistical tools. To provide consistency in the way that toxicology data are analyzed, regulatory agencies have provided guidance regarding the statistical methods to be used. The aforementioned peer review panel stated:
“The selection of the types of statistical methods to be performed is totally dependent upon the design of the toxicology study, and on the questions expected to be answered, as discussed in the US FDA Redbook (FDA, 2000). Hypothesis testing statistical analyses as described by WHO (1987), Gad (2001), and OECD (2002b) include those tests that have been traditionally conducted on data generated from rodent 90-day and chronic toxicity studies. These are also the procedures that have been widely accepted by regulatory agencies that review the results of subchronic and/or chronic toxicity tests as part of the product approval process. There are many other statistical tests available such as 2k factorial analysis when k factors are evaluated, each at two levels, specific dose–response contrasts, and generalized linear modeling methods, but these methods typically have not been used to evaluate data from toxicology studies intended for regulatory submissions”
Commenting on the statistical analysis used originally to analyze the toxicology data for MON 863 conducted at Covance labs, the expert panel also stated:
“All of these statistical procedures are in accordance with the principles for the assessment of food additives set forth by the WHO (1987). Moreover, these tests represent those that are used commonly by contract research organisations throughout the world and have generally been accepted by FDA, EFSA, Health Canada, Food Standards Australia New Zealand (FSANZ), and the Japanese Ministry of Health and Welfare. In fact, EFSA (2004) in their evaluation of the Covance (2002) study noted that it ‘‘was statistically well designed’’.”
de Vendomois et al., (2009) selected non-traditional statistical tests to assess the data and failed to consider the entire data set in order to draw biologically meaningful conclusions. Their limited approach generated differences that, while being statistically significant, are insufficient to draw conclusions without considering the broader dataset to determine whether the findings are biologically meaningful. In Doull et al., (2007) the expert panel clearly stated:
“In the conduct of toxicity studies, the general question to be answered is whether or not administration of the test substance causes biologically important effects (i.e., those effects relevant to human health risk assessment). While statistics provide a tool by which to compare treated groups to controls; the assessment of the biological importance of any ‘‘statistically significant’’ effect requires a broader evaluation of the data, and, as described by Wilson et al. (2001), includes:
- Dose-related trends
- Reproducibility
- Relationship to other findings
- Magnitude of the differences
- Occurrence in both sexes.”
Doull et al., (2007) raised questions regarding the appropriateness of some of the statistical analyses described in Seralini et al., (2007):
“The statistical analyses of the serum biochemistry, haematological, and clinical chemistry data conducted by Seralini et al. (2007) and by Monsanto were similar in concept as both used testing for homogeneity of variance and various pair-wise contrasts. The principle difference was that Seralini et al. (2007) did not use an ANOVA approach. The use of t-tests in the absence of multiple comparison methods may have had the effect of increasing the number of statistically significant results (emphasis added). The principle difference between the Monsanto and Seralini et al. (2007) analyses was in the evaluation of the body weight data. Monsanto used ‘traditional’ ANOVA and parametric analyses while Seralini et al. (2007) used the Gompertz model to estimate body weight as a function of time. The Gompertz model assumes equal variance between weeks, an assumption unlikely to hold with increasing body weights. While not inappropriate, as previously stated the Gompertz model does have limitation with respect to the interpretation of the results since it was not clear from the published paper whether Seralini et al. (2007) accounted for the changing variance and the correlated nature of the body weight data over time (emphasis added).”
Based on the expert panel conclusions in Doull et al., (2007); the statistical analysis used by, and the conclusions reached in, the de Vendomois et al. (2009) publication need to be carefully assessed. The authors use of inappropriate statistical methods in the examples below illustrate how inadequate analyses underpin the false and misleading claims found in de Vendomois et al., (2009).
Inappropriate use of False Discovery Rate method. De Vendomois et al., (2009) conducted t-test comparisons among the test and control and then applied the False Discovery Rate (FDR) method to adjust the p-values and hence the number of false positives. The FDR method is similar to many of the multiple comparison procedures that are available for controlling the family-wise error rate. Monsanto did not use any procedures for controlling the percentage of false positives for two reasons: (1) preplanned comparisons were defined that were pertinent to the experimental design and purpose of the analysis, i.e., it was not necessary to do all pairwise comparisons among the test, control, and reference substances and; (2) to maintain transparency and to further investigate all statistically significant differences using the additional considerations (Wilson et al, 2001) detailed above.
Inappropriate power assessment method. De Vendomois et al., (2009) claim that the Monsanto study had low power and support their claim with an inappropriate power assessment that is based on a simple t-test comparison of the test and control using an arbitrary numerical difference. This type of power assessment is incorrect because Monsanto used a one-way ANOVA, not a simple t-test. The appropriate power assessment should be relative to the ANOVA and not a simple t-test. In addition, an appropriate power assessment should be done relative to the numerical difference that constitutes a biologically meaningful difference.
Other non-traditional statistical methods. De Vendomois et al., (2009) also claim that Monsanto did not apply the described statistical methods and simply used a one-way ANOVA and contrasts. This is a false statement since Monsanto used Levine’s test to check for homogeneity of variances and if the variances were different the one-way ANOVA was conducted on the ranks rather than the original observations, i.e., Kruskal-Wallis test.
Specific examples of flawed analysis and conclusions.
De Vendomois et al., (2009) have compared the results across toxicology feeding studies with three different biotech crops using some of the same statistical tests that were used in the previous publication (Seralini et al, 2007). Each of these biotech crops (MON 863, MON 810, NK603) are the result of unique molecular transformations and express different proteins. De Vendomois et al., (2009) claims that all three studies provide evidence of hepatorenal toxicity by their analysis of clinical pathology data only. One might anticipate, if these claims were true, that similar changes in clinical parameters could be observed across the three studies and that the changes observed would be diagnostic for kidney and liver toxicity and would be accompanied by cytopathological indications of kidney or liver disease. However, as shown in Tables 1 and 2 in Vendomois et al., (2009), the statistically significant “findings” in clinical parameters are different across studies, suggesting that these are more likely due to random variation (type one errors) rather than due to biologically meaningful effects. Moreover, as indicated below, there is no evidence of any liver and kidney toxicity in these studies, particularly in relation to other data included in the original study reports that is not mentioned in Vendomois et al., (2009).
NK603 - Kidney
For the NK603 study (Table 1), de Vendomois et al., (2009) listed data from some of the measured urinary electrolytes, urinary creatinine, blood urea nitrogen and creatinine, phosphorous and potassium as evidence of renal toxicity. It has been pointed out that urinalysis may be important if one is testing nephrotoxins (Hayes, 2008), particularly those that produce injury to the kidney. However, it has also been noted that “Urinalysis is frequently of limited value because the collection of satisfactory urine samples is fraught with technical difficulties” (Hayes, 2008). There was a lot of variability for some of the urinary electrolytes as indicated by the high standard deviations that may be attributed to the technical difficulties in collecting satisfactory urine samples.
Examining the original kidney data for NK603, the urine phosphorous values are generally comparable for 11% and 33% NK603 males and the 33% reference groups, while the 33% controls are generally lower than all groups. For females, 33% control females also had slightly lower phosphorous values, but they were not statistically different from 33% NK603 females, unlike males where the 33% NK603 male value was statistically different (higher) than 33% controls. When the blood phosphorous values were compared, there was a slight, but statistically significant reduction in 33% NK603 males compared to controls (but not references) at week 5, and there were no statistically significant differences in NK603 male and female blood phosphorous levels when compared to controls at the end of the 14 week study.
There were no statistically significant differences in urine sodium in males at weeks 5 and 14 in the original analysis (in contrast to the reanalysis reported by de Vendomois et al., 2009). As with phosphorous, there was considerable variability in urine sodium across all groups. The same results were observed for females. In addition, blood sodium levels for 11 and 33% NK 603 males and females were not different from controls. It is apparent when reviewing the data in the table below that the measured urinary electrolytes for the NK603 groups were similar to the values for reference, conventional (e.g., non-GM) corn groups.
Looking at the other parameters listed in Table 1 (de Vendomois et al., 2009), while there was a slight increase in urine creatinine clearance in 33% NK603 males at the interim bleed at week 5 compared to the controls and reference population, this was not apparent at the end of the study when the rats had been exposed longer to the test diets. There was no difference in urine creatinine levels in males. Blood creatinine levels were slightly, but statistically significantly lower in high dose males compared to controls at week 5. Increases in creatinine, not reductions are associated with renal toxicity. The same response was observed for serum urea nitrogen, a slight reduction at week 5 and no differences at in male blood creatinine or urea nitrogen at the end of the study. BUN, like creatinine, is not a very sensitive indicator of renal injury” (Hayes, 2008). Thus the small differences in BUN and serum and urine creatinine are not suggestive of kidney injury.
There was no evidence of changes in other urinary parameters such as pH, specific gravity, protein, sodium, calcium, chloride, volume and kidney weights. The most important factor relating to the kidney that de Vendomois et al., (2009) did not consider was the normal microscopic appearance of the kidneys of rats fed NK603 grain. There was no evidence of treatment-related renal pathologic changes that the authors ignored in their risk assessment, a critical biological factor that an objective, scientific assessment would have considered.
MON 810 - Kidney
If Table 2 in de Vendomois et al., (2009) is examined, none of the aforementioned “findings” listed in Table 1 for NK603 are consistent except for blood urea nitrogen. Kidney weight data was listed, but this was not included in Table 1 for NK603. If the hypothesis of renal toxicity is correct, it is scientifically reasonable to have expected to observe at least some of the same “findings” between studies. The fact that there were no common findings supports the original conclusions reached by the investigative laboratory (and supported by regulatory agency review of these studies) that there is no evidence of kidney toxicity in rats fed either MON 810 or NK603 grain. Indeed, the data alleged by de Vendomois et al., (2009) to be indicative of kidney findings are more attributable to random variation that is commonly observed in rodent toxicology studies, which is well discussed in publications such as Doull, et al., (2007).
In Table 2, de Vendomois et al., (2009) highlights absolute kidney weights for males as being suggestive of kidney toxicity. The scientific basis for this assertion is unclear because there is no differences in male or female kidney weights (absolute, relative to body weight or brain weight) as shown in the table below:
De Vendomois et al., (2009) also lists blood urea nitrogen as indicative of kidney toxicity, yet there were no statistically significant differences in either MON 810 males or females when compared to controls (Hammond et al., 2006). In the absence of any other changes in urine or blood chemistry parameters that could be suggestive of kidney toxicity, and in consideration of the normal histologic appearance of kidneys of rats fed MON 810 grain, there is no scientific data to support the assertion of kidney toxicity in MON 810 fed rats.
NK603/MON 810 liver
Although de Vendomois et al., (2009) lists “findings” in Table 1 and 2 as being indicative of liver toxicity, analysis of these “findings” does not support this conclusion. There are no common “findings” in the liver between both studies. For NK603 de Vendomois et al., (2009) listed liver weights and serum alkaline phosphatase; for MON 810, serum albumin and albumin/globulin ratio. For NK603, the original analysis did not demonstrate statistical differences in absolute or, relative (to body or brain) liver weights for NK603 males and females compared to controls. Therefore, the statistical differences cited by de Vendomois et al., (2009) must be owing to the non-traditional statistical methods being used for their reanalysis of liver weight data. In regard to serum alkaline phosphatase, there were no differences for NK603 males or females when compared to controls; again de Vendomois et al., (2009) report statistical differences, but examination of the original data shows that the values for NK603 males and females are similar to controls and well within the range of values for the reference controls. There were no other associated changes in other liver enzymes, bilirubin, or protein that would be changes associated with liver toxicity. Lastly, but most importantly, the microscopic appearance of NK603 male and female livers was within normal limits for rats of that age and strain; therefore there was no evidence of liver toxicity. Similarly for rats fed MON 810, the only findings de Vendomois et al., (2009) list to support a conclusion of liver toxicity was albumin and albumin/globulin ratios. Contrary to the analysis in Table 2 of de Vendomois et al., (2009), there were no statistically significant differences in male or female serum albumin levels based on the original analysis. There were similarly no statistically significant differences in albumin/globulin with the exception of a slight decrease for 11% MON810 females when compared to controls at week 5. There were no differences observed at week 14 when the rats had been on test diets longer, nor were the differences dose related as they were not apparent in 33% MON 810 females relative to controls. The numerical values for serum albumin and albumin/globulin for MON 810 males and females were also similar to values for the reference groups. Consistent with NK603 rats, there were no other changes in serum liver enzymes, protein, bilirubin, etc., that might be associated with liver toxicity. The liver weights also appeared within normal limits for rats of the same strain and age used, again, consistent with a conclusion of no evidence of liver toxicity. In summary, no experimental evidence supports the conclusion for liver toxicity in rats fed NK603 and MON 810 grain as claimed by de Vendomois et al., (2009).
Kinetic plots
De Vendomois et al., (2009) has also presented some kinetic plots showing time-related variations for selected clinical parameters chosen for discussion. For 11% (low dose) control fed females, this publication reports that there is a trend for decreasing triglyceride levels over time (week 5 compared to week 14) whereas for 11% MON 863 fed rats, levels increase slightly during the same time period. It is unclear why this publication used these complicated figures to assess these data sets since the same time course information can be obtained by simply comparing the mean data for the group at the two time points. Using this simpler method to assess the data, low dose control triglycerides dropped from a mean of 56.7 at week 5 to 40.9 at week 14. Low dose MON 863 female triglycerides increased slightly from 50.2 to 50.9. What de Vendomois et al., (2009) fails to mention is that high dose control female triglyceride levels increased from 39.3 at week 5 to 43.9 at week 14 and high dose MON 863 triglyceride levels decreased from 54.9 to 46.7. These trends are opposite from what occurred at the low dose, and the low dose trends are, therefore, not dose related. For the female reference groups, triglycerides went either up or down a bit between weeks 5 to 14, illustrating that these minor fluctuations occur naturally. Since most of the other figures reported were for the low dose groups, the trend for the high dose was sometimes opposite to that observed at the low dose. In summary, none of this analysis changes the conclusion of the study that there were no treatment-related adverse effects in rats fed MON 863 grain.
Summary
To summarize, as with the prior publication of Seralini et al, (2007), de Vendomois et al., (2009) uses non-traditional statistical methods to reassess toxicology data from studies conducted with MON 863, MON 810 and NK603 to reach an unsubstantiated conclusion that they have found evidence for safety concerns with these crops. As stated by the expert panel that reviewed the Seralini et al 2007 paper (Doull et al., 2007) “In the conduct of toxicity studies, the general question to be answered is whether or not administration of the test substance causes biologically important effects (i.e., those effects relevant to human health risk assessment). While statistics provide a tool by which to compare treated groups to controls; the assessment of the biological importance of any ‘‘statistically significant’’ effect requires a broader evaluation of the data, and, as described by Wilson et al. (2001), includes:
- Dose-related trends
- Reproducibility
- Relationship to other findings
- Magnitude of the differences
- Occurrence in both sexes.
A review of the original data for clinical parameters, organ weights and organ histology also found no evidence of any changes suggestive of hepato/renal toxicity as alleged in the de Vendomois et al., (2009) publication. This same publication also made false allegations regarding how Monsanto carried out their statistical analysis which has been addressed above.
Although there are many other points that could be made in regards to de Vendomois et al., (2009), given the fact that these authors continue to use the same flawed techniques despite input from other experts, it is not worthwhile to exhaustively document all of the problems with their safety assessment. Most importantly, regulatory agencies that have reviewed the safety data for MON 863, MON 810 and NK603 (including data from the 90 day rat toxicology studies reassessed by de Vendomois et al., 2009) have, in all instances, reached a conclusion that these three products are safe for human and animal consumption and safe for the environment. Peer reviewed publications on 90 day rat feeding studies with NK603, MON 810 and MON 863 grain have also concluded that there are no safety concerns identified for these three biotechnology-derived crops.
Additional Background:
Over the last five years, Seralini and associated investigators have published a series of papers first regarding glyphosate and later regarding Genetically Modified Organisms (GMOs, specifically MON 863). Reviews by government agencies and independent scientists have raised questions regarding the methodology and credibility of this work. The paper by de Vendomois et al. (December 2009) is the most recent publication by this group, and continues to raise the same questions regarding quality and credibility associated with the prior publications.
Seralini and his associates have suggested that glyphosate (the herbicide commonly referred to as “Roundup”™, widely used on GM crops (Roundup Ready™ and others) is responsible for a variety of human health effects. These allegations were not considered to be valid human health concerns according to several regulatory and technical reviews. Claims of mammalian endocrine disruption by glyphosate in Richards at al. (2005) were evaluated by the Commission d”Etude de la Toxicité (French Toxicology Commission), which identified major methodological gaps and multiple instances of bias in arguments and data interpretation. The conclusion of the French Toxicology Commission was that this 2005 publication from Seralini’s laboratory served no value for the human health risk assessment of glyphosate. A subsequent paper from Seralini’s laboratory, Benachour et al. (2009), which was released via the internet in 2008, was reviewed by the Agence Française de Sécurité Sanitaire des Aliments (AFSSA, the French Agency for Food Safety). This review also pooled Richard et al (2005) and Benachour et al (2007) from Seralini’s laboratory under the same umbrella of in vitro study designs on glyphosate and glyphosate based formulations. Again, the regulatory review detailed methodological flaws and questionable data interpretation by the Seralini group. The AFSSA final remarks of their review were “the French Agency for Food Safety judges that the cytotoxic effects of glyphosate, its metabolite AMPA, the tensioactive POAE and other glyphosate-based preparations put forward in this publication do not bring out any pertinent new facts of a nature to call into question the conclusions of the European assessment of glyphosate or those of the national assessment of the preparations”. In August 2009, Health Canada’s Pest Management Regulatory Authority (PMRA) published a response to a “Request for a Special Review of Glyphosate Herbicides Containing Polyethoxylated Tallowamine”. The requester submitted 12 documents, which included the same claims made in the Benachour et al. (2009) publication. The PMRA response to this request concluded “PMRA has determined that the information submitted does not meet the requirements to invoke a special review,” clearly indicating no human health concerns were raised in the review of those 12 documents in support of the request.
Regarding GMOs, Seralini et al. (2007) previously published a re-analysis of Monsanto’s 90-day rat safety studies of MON863 corn. Scientists and regulatory agencies who reviewed the 2007 publication did not support that paper’s conclusions on MON 863 and the review addressed many deficiencies in the statistical reanalysis (Doull et al., 2007; EFSA, 2007a; EFSA, 2007b; Bfr, 2007; AFFSA, 2007; Monod, 2007; FSANZ, 2007). These reviews of the 2007 paper confirmed that the original analysis of the data by various regulatory agencies was correct and that MON 863 grain is safe for consumption.
Using the MON 863 analysis as an example, Seralini et al. (2009) recently published a “review” article in the International Journal of Biological Sciences, claiming that improper interpretation of scientific data allowed sub-chronic and chronic health effects to be ignored in scientific studies of GMOs, pesticides, and other chemicals. This paper applies a complex analysis (principle component analysis) to demonstrate a difference in liver and kidney function between male and female rats. Despite the fact that these gender differences are well known and are demonstrated in control and GMO-fed animals, Seralini and his colleagues conclude that these normal findings demonstrate some type of sex-specific susceptibility to toxic effects. Based upon this reasoning, they proceed to over-interpret a variety of minor statistical findings in the MON 863 study. These very same conclusions were roundly criticized in 2007. In fact, the authors of this study admit that their observations “do not allow a clear statement of toxicological effects.”
De Vendomois et al., (2009) elected to ignore the aforementioned expert scientific reviews by global authorities and regulatory agencies and again have used non-standard and inappropriate methods to reanalyze toxicology studies with MON 863, MON 810 and NK603. This is despite more than 10 years of safe cultivation and consumption of crops developed through modern biotechnology that have also completed extensive safety assessment and review by worldwide regulatory agencies, in each case reaching a conclusion that these products are safe.
Although some Seralini group publications acknowledge some funding sources, there are no acknowledgements of funding bias and conflict of interest. Financial support for Seralini’s research includes the Committee for Research and Independent Information on Genetic Engineering (CRIIGEN) and the Human Earth Foundation. Seralini has been the Chairman of the Scientific Council for CRIIGEN since 1999. Seralini and this organization are known for their anti-biotechnology positions (http://www.crii-gen.org/). Both CRIIGEN and the Human Earth Foundation promote organic agriculture and alternatives to pesticides. It is interesting that over the last five years Seralini’s group has published at least seven papers, four of which specifically target Monsanto’s glyphosate-based formulations as detrimental to human health, and the remaining papers allege that Monsanto’s biotechnology or GMO crops have human health implications. In addition, Seralini has a history of anti-Monsanto media releases and statements, including those on YouTube, reflecting not only Seralini’s anti-Monsanto sentiment, but a lack of scientific objectivity.
See: (http://www.youtube.com/watch?v=HkRFGtyabSA; and http://www.youtube.com/watch?v=k_gF6gpSVdY).
Finally, it is worth noting the press release from CRIIGEN, issued at the time of release of the de Vendomois et al. publication:
“CRIIGEN denounces in particular the past opinions of EFSA, AFSSA and CGB, committees of European and French Food Safety Authorities, and others who spoke on the lack of risks on the tests which were conducted just for 90 days on rats to assess the safety of these three GM varieties of maize. While criticizing their failure to examine the detailed statistics, CRIIGEN also emphasizes the conflict of interest and incompetence of these committees to counter expertise this publication as they have already voted positively on the same tests ignoring the side effects.”
This rather remarkable approach clearly indicates how far the authors of this publication have drifted from appropriate scientific discourse regarding GMO safety data. While they would reject criticisms of their methods and arguments by regulatory authorities and other eminent toxicology experts, most persons seeking an objective analysis will welcome broad expert input and a full assessment of the weight of evidence on the subject.
References
AFFSA, 2007. de l’Agence franc¸aise de se´curite´ sanitaire des aliments relatif a` la re´cente e´tude publie´e1 sur le maı¨s ge´ne´tiquement modifie´ MON 863. Agence Franc¸aise de Se´curite´ Sanitaire Des Aliments. La Directice Ge´ne´rale. AFFSA Dossier No. 2007-SA-0109, 26 April 2007.
Benachour. N. and Séralini, E. Glyphosate Formulations Induce Apoptosis and Necrosis in Human Umbilical, Embryonic, and Placental Cells, Chem. Res. Toxicol. 2009, 22, 97–105
Benachour, N., Sipahutar, H., Moslemi, S., Gasnier, C., Travert, C., and Séralini, G.E. (2007) Time and dose-dependent effects of roundup on human embryonic and placental cells and aromatase inhibition. Arch. EnViron. Contam. Toxicol. 53, 126-133
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Covance, 2002. 13-Week Dietary Subchronic Comparison Study with MON 863 Corn in Rats Preceded by a 1-Week Baseline Food Consumption Determination with PMI Certified Rodent Diet #5002. Prepared by: Covance Laboratories, Inc., Vienna, Virginia for Monsanto Company, St. Louis, Missouri. Covance Study No. 6103-293, 17 December 2002.
De Vendomois, J.S., Roullier, F., Cellier, D. and Seralini, G-E. 2009. A comparison of the effects of three GM corn varieties on mammalian health. Int. J. Biol. Sci. 5:706-726.
Doull, J., Gaylor, D., Greim, H.A., Lovell, D.P., Lynch, B. and Munro, I.C. 2007. Report of an Expert Panel on the reanalysis by Seralini et al. (2007) of a 90-day study conducted by Monsanto in support of the safety of a genetically modified corn variety (MON 863). Food and Chemical Toxicology 45 (2007) 2073–2085.
European Food Safety Authority (EFSA) (2007a). Statement of the Scientific Panel on Genetically Modified Organisms on the analysis of data from a 90-day rat feeding study with MON 863 maize. Adopted 25 June 2007.
http://www.efsa.europa.eu/cs/BlobServer/Statement/GMO_statement_MON863.pdf?ssbinary=true
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FSANZ. Review of the report by Séraliniet al., (2007): “New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity”. Food Standards Australia New Zealand July 2007.
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Hammond, B., Lemen, J., Dudek, R., Ward, D., Jiang, C., Nemeth, M., Burns, J., 2006. Results of a 90-day safety assurance study with rats fed grain from corn rootworm-protected corn. Food Chem. Toxicol. 44, 147–160.
Hayes, A.W. Principles and Methods of Toxicology. 5th Edition. Informa Healthcare USA, New York. 2008. Pages 1246, 1524.
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Monod H., 2007. Expérience sur rats menée par Monsanto en 2001-2002 avec certains régimes comportant du maïs génétiquement modifié: analyse statistique des courbes d’évolution du poids. Study conducted upon request of the CGB (Commission du Génie Moléculaire, France).
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Tuesday, December 22, 2009
Industry views: Five Troubling Aspects of the Copenhagen Accord
Five Troubling Aspects of the Copenhagen Accord
Even though the climate change PR machines are spinning away in the aftermath of Copenhagen’s COP 15, a few of the Copenhagen Accord’s more troubling consequences are not getting the attention they deserve.
Senator McCain called “the agreement to take note of the accord” reached by the United States and a handful of developed nations a “nothing burger.” Senator Kerry, on the other hand, believes the accord is important and called China’s participation “the most critical thing” to ensuring Senate passage of the national energy tax, even though few observers believe China will actually do anything to curtail their growing use of carbon-based energy. Meanwhile, the question of whether the outcome in Denmark was enough to advance international efforts to control emissions can best be summarized by Henry Derwent, president of the Geneva-based International Emissions Trading Association, who noted that the climate talks were a “step backward” in terms of a signal that will support carbon prices.
While the Copenhagen Accord does not represent a major change from the status quo, there are a few troubling aspects of the U.S. effort in Copenhagen worth noting.
First, U.S. negotiators opposed efforts from China and India to ban the use of border tariffs on energy-intensive exports. That means the U.S. actively fought to leave the prospect of Smoot-Hawley-type trade wars on the table for Senate cap-and-trade negotiators. The United States has benefited greatly from free trade; now the U.S. government is opposing free trade.
Second, unlike China and other developing countries, the U.S. will allow “international consultations and analysis” of our greenhouse gas emissions. It is not clear how intrusive these international consultations will be, but with millions of sources of greenhouse gas emissions, it’s hard to believe that they won’t in some way encroach on U.S. sovereignty.
Third, the U.S.’s commitment to hand over billions of dollars a year in taxpayer money was a premature gesture that will only serve as the new floor for developing nations in the next round of international talks. Why would nations in the third world operate under this agreement if they can now see that the starting point for COP 16’s bargaining talks is $30 billion?
Fourth, we must consider the sheer size of the U.S. delegation; press accounts reveal that in addition to the President, five cabinet officials, four other high ranking officials, one czar, over thirty Members of Congress and a host of staff attended all or part of the conference. The United States spent millions to send a small army to Copenhagen to forge a non-binding “accord” that very few Americans view as a priority.
Finally, contrary to Senator Kerry’s hopes, China’s willingness to sit at a non-binding negotiating table will not ease the pain a national energy rationing cap-and-trade tax will cause for American families and is certainly not a sufficient gesture to justify its passage.
Ultimately, Copenhagen will have no impact on the outcome of the cap-and-trade legislation moving through Congress. As we have just seen in the health care debate, Senate passage of this increasingly unpopular measure will depend on how much taxpayer money Majority Leader Reid is willing to give away to his fence-sitting colleagues to reach the 60 votes necessary to move this bill forward.
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