Programs: Science and Policy
http://www.aaas.org//spp/cstc/stc/Archive/stc09/09_03_stcnewsletter.shtml
Science and Technology in Congress
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Executive Order Expands Support for Stem Cell Research
President Obama dominated March 9 headlines by signing an executive order expanding federal support for embryonic stem cell research. "We will vigorously support scientists who pursue this research," he said. "And we will aim for America to lead the world in the discoveries it one day may yield."
The order lifts a directive from President Bush that limited federal research funds to stem cell lines created before the August 9, 2001 annoucement . At the time Bush issued the order, there appeared to be several dozen such lines, but scientists soon found the actual number to be much smaller. Privately-funded scientists continued to derive and improve stem cell lines subsequent to the Bush cutoff.
Though a bill to repeal Bush's stem cell policy went through Congress twice, Bush vetoed it both times, and there were not enough congressional votes for an override. In 2007 Bush issued a largely symbolic executive order encouraging research into alternative methods of deriving stem cells.
Obama pledged to overturn the Bush policy during his presidential campaign, and less than 100 days into his presidency, he did so. Obama's order allows federal funding for research on embryonic stem cell lines derived on any date so long as they are derived under certain ethical guidelines. The order does not lay out these guidelines but rather allows 120 days for their development by the Secretary of Health and Human Services (HHS) through the Director of the National Institutes of Health.
Longtime stem cell research supporters Diana DeGette (D-CO) and Mike Castle (R-DE) want to codify the policy into law, and to that end they have introduced two stem cell bills in the House. The Stem Cell Research Enhancement Act (HR 873) is similar to previous bills of the same name vetoed by President Bush: It would allow federal funding for embryonic stem cell research while setting out ethical guidelines for the derivation of the cells. The Stem Cell Research Improvement Act (HR 872) would do the same things, but it includes additional guidance and reporting requirements for NIH. Senators Tom Harkin (D-IA) and Arlen Specter (R-PA) have also reintroduced their stem cell bill (S 487), a companion bill to HR 873.
Obama's order does not affect a congressional ban on the use of federal funds for deriving embryonic stem cell lines. A long-standing amendment to the appropriations bill for HHS, commonly known as the Dickey-Wicker amendment after the U.S. Representatives who introduced it, bans federal funding of research that involves the creation or destruction of an embryo. Because of this ban, stem cell lines eligible for federal funds have been derived in the private sector, preventing federal funds from going directly toward the destruction of an embryo.
More information can be found on AAAS's Stem Cell Policy Brief.
--Erin Heath
Obama Making Changes to Rulemaking Process, Emphasizes Scientific Integrity
In his early days in office, President Obama has announced several changes to the process used to craft federal regulations. Of special interest to the scientific community was a March 9 presidential memorandum directing the White House Office of Science and Technology Policy (OSTP) to devise a policy to ensure scientific integrity in federal decision-making.
The memo states, "Science and the scientific process must inform and guide decisions of my Administration on a wide range of issues, including improvement of public health, protection of the environment, increased efficiency in the use of energy and other resources, mitigation of the threat of climate change, and protection of national security. The public must be able to trust the science and scientific process informing public policy decisions. Political officials should not suppress or alter scientific or technological findings and conclusions." The recommendations of OSTP are due in 120 days.
Other orders keep with Obama's campaign promises of greater transparency and accountability in government and will likely affect the way scientific information is used in rule making. One such action was a repeal of President Bush's Executive Order 13422, which had tightened the control of the Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs (OIRA) over rulemaking and, critics charged, significantly raised the hurdles for developing regulations intended to protect public safety and health. Brad Miller (D-NC), chair of the House Science and Technology Subcommittee on Investigations and Oversight, praised Obama's action.
In addition, Obama issued a memo directing OMB Director Peter Orszag and agency heads to produce within 100 days a list of suggested changes to the process, signaling that he may make additional revisions to the rulemaking process early in his term. OMB has invited public comments on how to improve the process and principles governing regulation.
-- Kasey White
Patent Reform Debate Returns to Congress
The longstanding debate over patent reform was revived in the 111th Congress with the introduction of the Patent Reform Act of 2009 (S. 515; H.R. 1260). Identical bills were introduced in the Senate by Judiciary Chairman Patrick Leahy (D-VT) and Sen. Orrin Hatch (R-UT) and in the House by Judiciary Chairman John Conyers (D-MI) and Rep. Lamar Smith (R-TX). The new legislation, based largely on the Patent Reform Act of 2007, marks the third significant attempt to overhaul the patent system in five years. The 2007 bill passed the House last year but stalled in the Senate.
While most parties agree that patent system reform is needed, the question confronting policymakers is how to balance reform with the economic realities of innovation and the property rights of inventors and patent holders. It's a question that has confounded previous reform attempts, and opposition to the current bill has already surfaced.
While high tech industry leaders support the legislation, many in the pharmaceutical and biotechnology sectors object to the bill's proposed changes. In response, members of the House and Senate Judiciary Committees have written letters to committee leadership asking for a cautious approach to the issue.
As in the previous Congress, much of the current debate revolves around the determination of damages in cases of infringement. It was this debate that helped derail the previous bill, when Senate Judiciary Ranking Member Arlen Specter (R-PA) withdrew his support last year.
The 2009 bill would set a standard for damages based on the true value of specific patents, which would likely limit jury damage awards. High tech firms favor these limits since technology products can consist of hundreds of individual patents. In the pharmaceutical industry, on the other hand, products tend to rely on as few as a single patent, and limiting damages might reduce patent values (see Patent Reform Policy Brief).
The complexity of the debate was on display during a March 10 hearing by the Senate Judiciary Committee, in which representatives from academia and industry alternately praised and criticized the bill's language. IBM and Micron leaders hailed the potential to get litigation and damages under control, which could increase the funding available for research and development.
On the other hand, representatives from Johnson & Johnson and tech firm Tessera argued that the problem of excessive damages has been exaggerated, advocating policy steps to limit frivolous lawsuits without constraining damage awards. Concern was also raised that small startups reliant on strong protections would be disproportionately hurt by the changes.
Beyond damages, another key holdover from the 2007 bill is a proposal to adopt a "first-to-file" patent system over the current "first-to-invent" system. Proponents of first-to-file, which is used in most other industrialized countries, argue that it would make the system more efficient, while detractors say it could yield lower-quality patents and give an unfair advantage to inventors more familiar with the filing process. The change could also make it harder for university researchers to patent ideas that have been published or presented at conferences, by placing the emphasis on time of application versus time of invention.
The new bill keeps a proposal to create a system of post-grant patent review but extends the window for review to occur. The Association of American Universities has expressed mixed feelings about the language, arguing that post-grant review is important for major research universities but also could lead to an increase in patent challenges.
The new bill does depart from previous legislation in some ways. It leaves out language requiring the publication of patent applications after 18 months, partly out of a concern for applicants' trade secrets. It also does not address the issue of inequitable conduct, which deals with deceptive practices by patent litigants.
Disagreement in the previous Congress was such that Sen. Jon Kyl (R-AZ) introduced his own reform bill late last year as an alternative to the Leahy bill, with some significant differences (Oct 2008 STC newsletter). Kyl has not ruled out reintroducing his bill if no agreement can be reached otherwise. The Senate Judiciary Committee began a markup of the bill on March 26, which will continue into the upcoming weeks.
-- Matt Hourihan
Stimulus Contains $21.5 billion for R&D Funding
Late at night on February 12, House and Senate negotiators reached agreement on a final version of the American Recovery and Reinvestment Act of 2009 (HR 1), a $789 billion economic stimulus package to deal with the current economic crisis that was quickly signed into law.
The bill contains $21.5 billion in federal research and development (R&D) funding – higher than either the House or Senate versions. In almost every case when the House and Senate had different numbers for R&D funding agencies, House-Senate conference negotiators chose the higher number. The final stimulus would allocate $18.0 billion for the conduct of R&D and $3.5 billion for R&D facilities and large research equipment. There is additional money for non-R&D, science and technology-related programs, higher education construction and other education spending of interest to academia.
The three agencies highlighted for their support of economic competitiveness-related basic research all see large increases. The National Science Foundation (NSF) received $3.0 billion; the Department of Energy's Office of Science (DOE OS) received $1.6 billion; and Commerce's National Institute of Standards and Technology (NIST) received $600 million; nearly all of these supplementals are for R&D activities.
In addition, the stimulus bill provides $400 million to DOE for the Advanced Research Projects Agency - Energy (ARPA-E), a new research agency authorized in the America COMPETES Act but never funded until now. The Department of Energy’s (DOE) energy programs would also be a winner with $3.5 billion for R&D and related activities in renewable energy, energy conservation, and fossil energy, part of nearly $40 billion total for DOE in weatherization, loan guarantee, clean energy demonstration, and other energy program funds.
The National Institutes of Health (NIH) recieved $10.4 billion, turning around a NIH budget that has been in decline since 2004. The National Aeronautics and Space Administration (NASA) received $1.0 billion with an emphasis on climate change-related satellite missions.
The final stimulus bill challenges the major R&D funding agencies to spend these large stimulus appropriations quickly, while at the same time spending them well. The final stimulus bill does not contain provisions in earlier versions of the bill requiring nearly all of the funding to be awarded within 120 days, but the intent remains to spend the money as quickly as possible to provide immediate economic stimulus. Nearly all of the money is designated as FY 2009 money, and most agencies are now allowed to obligate funds until the end of September 2010, and spend out the money even after that if necessary. To that end, the House Science and Technology subcommittee on Investigations and Oversight held a March hearing on accountability and transparencey in the stimulus, hearing from leaders and inspector generals of several science agencies.
Agencies have begun to announce how they intend to allocate the funds. Links to agency plans for use of stimulus funds are available on the AAAS website, along with additional details on stimulus funding.
-- Kei Koizumi and Kasey White
FY 2009 Appropriations Process Complete
Almost six months into the fiscal year on March 11, a $410 billion fiscal year (FY) 2009 omnibus bill that combined the nine unfinished appropriations bills was signed into law (P.L. 111-8). The Democratic Congress' decision to delay finalizing the 2009 appropriations and avoid the threat of a veto by former President Bush seems to have paid off and allowed the new 111th Congress to provide additional domestic discretionary funds, including increases for research and development (R&D).
Included in the omnibus bill is $151.1 billion in federal R&D, an increase of $6.8 billion or 4.7 percent above the FY 2008 estimate. As a result, every major R&D funding agency would receive an increase greater than the expected rate of inflation, and in many cases the final FY 2009 numbers are larger than the budget request submitted by the previous administration to the 110th Congress.
The bill includes large gains for agencies specified in the America COMPETES Act: the National Science Foundation (NSF), the Department of Energy's Office of Science (DOE OS), and Commerce's National Institute of Standards and Technology laboratories (NIST) would see increases in funding for FY 2009 consistent with doubling their budgets over a decade. The National Institutes of Health (NIH) would also receive a significant boost, with a total budget of $30.5 billion, a 3.2 percent increase.
Additional funds for research were allocated through the stimulus bill, which technically was an emergency supplemental appropriations bill, even though it passed before the FY 2009 appropriations process was complete.
Additional agency details are available on the AAAS R&D Budget and Policy Project website.
-- Kei Koizumi, Lucas Adin, and Joanne Carney
On February 26, President Obama released his budget outline for fiscal year (FY) 2010. Although specific funding requests are expected to be released later this spring, the budget includes Administration priorities, including several increases in science and technology funding. Among the agencies that will see increases for their S&T activities are the Environmental Protection Agency (EPA), NASA, and the National Science Foundation (NSF).
Under the outline, EPA would receive a $3 billion increase to $10.5 billion. The budget places a strong emphasis on funding for climate change research and greenhouse gas (GHG) emissions reduction programs. The outline includes a request of $19 million for the creation and maintenance of a national greenhouse gas inventory and a proposal for a cap-and-trade program that seeks to reduce U.S. GHG emissions to 14 percent below 2005 levels by 2020 and 83 percent below 2005 levels by 2050.
For NASA, the budget requests $18.7 billion, highlighting funding for NASA’s space-based climate research programs, research and development of human and robotic space exploration, and aeronautics research. NSF’s request of $7 billion includes increases of unspecified amounts for graduate research, fellowships, faculty development, high-risk research proposals, and creation of a climate change education program.
At the Department of Commerce, both the National Oceanographic and Atmospheric Administration (NOAA) and the National Institute of Standards and Technology (NIST) would receive funding for their R&D programs. Specifically, NOAA is allocated $1.3 billion for development and acquisition of vital weather satellites and climate sensors, programs also funded under the stimulus bill that the budget seeks to build upon. NIST is allocated $70 million for its Technology Innovation Program and $125 million for its Hollings Manufacturing Partnership, which supports improvement of competitiveness through the advent of more efficient manufacturing processes.
Beyond these programs, the only specific mention of funding dedicated to research programs is at the Department of Health and Human Services, where the National Institutes of Health would receive $6 billion for cancer research, and the Department of the Interior, which would receive an increase of $130 million for the studies of wildlife adaptation to climate change and $50 million for environmental evaluations and technical studies of renewable energy projects on public lands and offshore areas.
The Department of Energy plan highlights development of smart grid technology, R&D on biofuels, renewable energy, and energy efficiency, and loan guarantees for “innovative energy technologies” including renewable energy, transmission projects, and carbon sequestration. DOE Secretary Stephen Chu appeared before the Senate Energy and Natural Resources Committee, House Science and Technology Committee and Senate Budget Committee to discuss his priorities for the agency. In these appearances, he emphasized support for the Office of Science and the need for transformational research on energy.
Other committees have begun examining the budget requests, even in the absences of a detailed submission. The House Appropriations Subcommittee on Commerce, Justice, Science, and Related Agencies held five hearings to discuss the state of science. The hearings focused on funding for agencies, such as NASA, NOAA, and NSF, and ways to increase American participation in science. The common denominator was that increased funding and participation could improve competitiveness and innovation. Representatives supported increased funding for science based agencies and strengthening math and science education. Members and witnesses alike noted the importance of stable support for R&D, as booms and busts often cripple projects.
--Phillip Chalker, Lucas Adin, and Kasey White
In Brief
Quick status reports to keep you up to date on recent S&T bills and hearings.
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The House Science and Technology Committee approved the Electronic Waste Research and Development Act of 2009 on March 25, after holding a hearing on the bill last month. The legislation would create a program within EPA to award grants for research on the management and disposal of electronic waste, as well as research on behavioral, social, and economic aspects of recycling. It would also award grants to universities and community colleges for improving their green engineering curricula and training programs. While several states have enacted regulations dealing with e-waste, no policy framework currently exists at the federal level.
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The House passed the National Nanotechnology Initiative Amendments of 2009 (HR 554), which would require a government roadmap for research on the environmental, health, and safety effects of nanotechnology. The new bill is identical to the NNI reauthorization bill that passed overwhelmingly in the House last year but stalled in the Senate.
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Senate Energy and Natural Resources Committee held a March 5 hearing on draft legislation that would double authorization levels for energy research and development over four years. The legislation would dedicate at least 10 percent of these funds to a "Grand Challenges Research Initiative."
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Rep. Edolphus Towns, D-NY, reintroduced the Great Ape Protection Act (HR 1326), designed to prohibit "invasive" research on great apes. Some scientists are concerned about the bills effects on disease research.
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The National Neurotechnology Initiative Act was introduced on March 12. Lead sponsors are Sen. Patty Murray (D-WA) on S 586 and Rep. Patrick Kennedy (D-RI) on HR 1483. One of its main goals is to establish a government office that would coordinate federal R&D related to treatments for brain illness and injury.
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The House Appropriations Subcommittee on Interior, Environment, and Related Agencies held a February 24 hearing to examine transferring the Forest Service from the Department of Agriculture to the Department of the Interior. Robin Nazzaro, GAO Director for Natural Resources & Environment, testified on GAO findings that potential long-term cost savings and efficiencies could be achieved but said that many other issues would need to be addressed.
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On March 25, the House Science and Technology Committee approved the National Water Research and Development Initiative Act of 2009, a bill intended to improve research on water management, conservation, and reclamation. The legislation would require the creation of a National Water Research and Assessment Plan, coordinate water-related federal R&D and education, encourage cooperation and information sharing by federal, state and local entities, and improve and standardize water-related data collection. The committee held a hearing on the bill earlier this month.
BACK TO TOP
Agency Updates
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John Holdren was confirmed on March 19 as Director of the White House Office of Science and Technology Policy (OSTP). Also on March 19, Jane Lubchenco was confirmed as Under Secretary of Commerce for Oceans and Atmosphere, where she will lead the National Oceanic and Atmospheric Administration. The Senate Commerce, Science and Transportation Committee held a hearing on February 12 to consider their nominations.
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In a March 4 memo, President Obama directed the Departments of the Interior and Commerce to reexamine a December 16, 2008 regulation that allowed federal agencies to bypass scientific reviews by the Fish and Wildlife Service or National Marine Fisheries Service on the effects of their actions on endangered species. The Obama memo directs agencies to follow the previous process, which entailed scientific studies by these agencies, until the reexamination is completed.
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EPA opened for public comment a proposal for mandatory reporting of emissions of carbon dioxide and other greenhouse gases to create a national greenhouse gas registry. Approximately 13,000 facilities, accounting for about 85 percent of greenhouse gases emitted in the United States, would be covered.
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Language included in the FY2009 omnibus appropriations package will restore reporting requirements to original levels required under the Toxics Release Inventory program, reversing changes made by President Bush in 2006. The appropriations bill restores the requirement for companies to report chemical releases that total 500 pounds a year, rather than the Bush-era rule that raised the level to 2,000 pounds
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The Interagency Autism Coordinating Committee, a federal advisory panel, has released its first blueprint for autism research. It is organized around six questions regarding diagnosis, biology, risk factors, treatments, services, and issues faced by autistic adolescents, adults and seniors.
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President Obama announced the formation of a Food Safety Working Group in response to a sharp rise in outbreaks related to tainted food. He also named his picks to lead the Food and Drug Administration: Former New York City health commissioner Margaret Hamburg as FDA commissioner and Baltimore health commissioner Joshua Sharfstein as FDA principal deputy commissioner.
Reports and Publications
CONGRESSIONAL RESEARCH SERVICE
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Wind Energy: Offshore Permitting (R40175)
The Bayh-Dole Act: Selected Issues in Patent Policy and the Commercialization of Technology (RL32076)
U.S. Global Climate Change Policy: Evolving Views on Costs, Competitiveness, and Comprehensiveness (RL30024)
Community Acceptance of Carbon Capture and Sequestration Infrastructure: Siting Challenges (RL34601)
Oversight of High-Containment Biological Laboratories: Issues for Congress (R40418)
Changes to Consultation Regulations of the Endangered Species Act (ESA) (RL34641)
GOVERNMENT ACCOUNTABILITY OFFICE
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Endangered Species Act: Many GAO Recommendations Have Been Implemented, but Some Issues Remain Unresolved (GAO-09-225R)
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Health Information Technology: Federal Agencies' Experiences Demonstrate Challenges to Successful Implementation (GAO-09-312T)
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Federal Land Management: Observations on a Possible Move of the Forest Service into the Department of the Interior (GAO-09-223)
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Chemical Regulation: Options for Enhancing the Effectiveness of the Toxic Substances Control Act (GAO-09-428T)
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NASA: Assessments of Selected Large-Scale Projects (GAO-09-306SP)
Informing Decisions in a Changing Climate (ISBN-13: 978-0-309-13748-5)
A Survey of Attitudes and Actions on Dual Use Research in the Life Sciences: A Collaborative Effort of the National Research Council and the American Association for the Advancement of Science (ISBN-13: 978-0-309-13140-7)
Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research (ISBN-13: 978-0-309-12499-7)
Restructuring Federal Climate Research to Meet the Challenges of Climate Change (ISBN-13: 978-0-309-13173-5)
The Distributional Consequences of a Cap-and-Trade Program for CO2 Emissions
Congressional Budget Office-
New Life, Old Bottles: Regulating First-Generation Products of Synthetic Biology
Synthetic Biology Project - International Forest Carbon in Congress: A Survey of Key Congressional Staff
Resources for the Future
AAAS News and Notes
AAAS Thanks Members of Congress for their Support of S&T
AAAS sent thank you letters to the leadership in both chamber of Congress, as well as to key appropriators and bipartisan members of the conference committee for including science and technology in the American Recovery and Reinvestment Plan.
AAAS Hosts Hearing on Antibiotic Resistance
On February 24 AAAS cosponsored a public briefing on Capitol Hill entitled "Antibiotic Use in Animal Agriculture and Antibiotic Resistance: Is There a Link?" Three experts talked about agricultural use of antibiotics and its effects on public health.
AAAS thanks Administration
After attending the signing of President Obama's executive orders on stem cells and scientific integrity, AAAS CEO Alan Leshner wrote to the President expressing gratitude for "a government that so visibly values science and sees, as we do, its relevance to virtually every issue of modern life."
Mark Your Calendar:
AAAS Forum on Science and Technology Policy
30 April - 1 May 2009
Washington DC Ronald Reagan Building and International Trade Center
The AAAS Forum on Science and Technology Policy will examine the political and economic outlook for science and technology in 2009. The symposium will also include discussion of energy and international climate policy, integrity in science, and the future of science journalism.
Frontiers in Science
Natural process that cause circular ocean currents - known as gyres - have coupled with human garbage to create islands of trash throughout the oceans. The largest of these islands, "The Great Pacific Garbage Patch" (GPGP), is located 500 nautical miles west of Hawaii. In 2008, estimates of the size of the island ranged range from twice the size of Texas to twice the size of United States. Without action, the area is projected to double in size within the next decade. The United Nations estimates that the GPGP kills over a million seabirds and 100,000 marine mammals yearly.
"Pacific Garbage Patch Still Growing." Geographical. June 2008, Vol. 80, Issue 6
Averett, Steven. "The Land of Flotsam and Jetsam." Waste Age. May 2008, Vol. 39 Issue 5, p102-102
