Science and Technology in Congress is a newsletter produced by the Center to provide timely, objective information to Congress on current science and technology issues.
On July 6 the National Institutes of Health (NIH) released its final guidelines on human stem cell research, opening the door to expanded federal funding of research involving embryonic stem cells. During the April-May public comment period, NIH received nearly 50,000 opinions on the draft guidelines that it had released in response to President Obama's Executive Order lifting restrictions on stem cell funding [see STC March, May 2009].
Perhaps the most important change from the draft guidelines was NIH's decision that previously-derived stem cell lines that follow the spirit of the new ethical guidelines - if not the exact documentation requirements - would be eligible for funding. AAAS and other groups had expressed concern that because informed consent standards have changed over time, the NIH draft may have excluded stem cell lines that had been ethically derived according to prevailing stem cell research standards in place at the time.
Now, according to the final guidelines, an NIH advisory panel will evaluate older stem cell lines, and the ultimate determination on whether they should qualify will rest with NIH director. The guidelines also articulate NIH's intent to develop a registry of eligible stem cell lines.
The following week, NIH posted a notice about how it will handle applications and awards for human embryonic stem cell research. It provided guidance for ongoing research projects and gave a status update on pending applications.
House Finishes Appropriations, Senate Making Progress
The House passed all twelve FY 2010 appropriation bills before leaving for its August recess - triple that of the Senate which has completed four. The Energy and Water, Homeland Security, Legislative Branch, and Agriculture bills have passed both chambers, paving the way for the conference process to begin in September, the last month of fiscal year 2009.
The Agriculture (H.R. 2997) bill passed the House on July 9 and was approved by the Senate on August 4. The Senate version includes $1.23 billion for the Agricultural Research Service and $1.306 billion for the National Institute of Food and Agriculture, formerly the Cooperative State Research, Education and Extension Service (CSREES), while the House version allocates $1.19 billion and $1.253 billion respectively.
Both the House and Senate passed the Energy and Water Appropriations Bill (H.R.3183) in July. Both chambers allocated the Department of Energy's Office of Science $4.9 billion, a 2.6 percent ($126 million) increase over FY 2009 and less than one percent under the President's request. The House would provide ARPA-E, a relatively new program to fund transformative energy research, with $15 million, but the Senate version makes no mention of ARPA-E.
Homeland Security (H.R. 2892, S. 1298) made it out of the Senate on July 9 after passing the House back in June. The Senate version includes $994.9 million for Science and Technology, a 6.7% increase ($62.3 million) over FY 2009, while the House version includes a smaller increase to $968 million.
The House passed the FY 2010 Labor, Health and Human Services, and Education appropriations bill (H.R. 3293) on July 24. The bill includes $31.3 billion for the National Institutes of Health (NIH), a 3.1 percent ($942 million) increase over FY 2009 and 1.6 percent ($500 million) more than the President's request. Approved by voice vote was an amendment by Rep. Darrell Issa (R-CA) to de-fund three peer-reviewed NIH grants related to HIV/AIDS prevention, a move to which AAAS and other scientific and medical organizations strongly object. The bill as passed also would eliminate $99 million for grants to public and private organizations to encourage teens to abstain from premarital sex, with Democrats arguing that there is little scientific evidence of such programs' effectiveness. The bill renews prior restrictions on the use of funds for research that creates or destroys human embryos. The Senate Appropriations Committee approved its version of thebill, with a smaller (1.5 percent) increase to $30.8 billion for NIH.
Even though much work remains on the FY 2010 appropriations process, the executive branch is already looking ahead to the FY 2011 budget cycle. The Office of Management and Budget (OMB) and the Office of Science and Technology Policy (OSTP) issued a memorandum to all federal agencies and departments outlining the science and technology (S&T) priorities for the fiscal year 2011 budgets. Agency S&T budgets in FY 2011 should address four challenges: the economy, energy and environment, public health, and national security. The memo also encourages agencies to develop"science of science policy tools" and emphasizes the importance that programs be managed under high ethical and scientific integrity standards.
Nine days after the National Governors Associations (NGA) and The Council of Chief State School Officers (CCSO) announced a project to establish a set of common core education standards in English and math, Sen. Chris Dodd (D-CT) and Rep. Vernon Ehlers (R-MI) reintroduced legislation (H.R. 2790, S. 1231) to promote a voluntary effort for states to adopt standards in science, technology, engineering, and math (STEM) education.
The NGA and CCSO's Common Core State Standards effort involves 49 states and territories. The groups plan to develop and implement "research and evidenced based math and English internationally benchmarked standards" to better prepare students academically. With U.S. students underperforming in international assessments, the NGS and CCSO hope the core standards will bring U.S. math and language skills up to par with countries it lags behind and address the regional disparities that exist due to the patchwork of state standards that exist today. While a draft of the mathematics standards has been leaked, the complete K-12 standards are not expected to be completed until December 2009.
The SPEAK Act (Standards to Provide Educational Achievement for Kids Act) would create national standards for STEM fields, similar to the standards that are to be created by the NGA and the CCSO. Rep. Ehlers last introduced the SPEAK Act in 2007.
The SPEAK Act amends the National Assessment of Educational Progress Authorization Act to include science as part of the assessments, which currently only include math and English. Additionally, this bill would task the National Governors Association Board with developing course content for grades K-12 and would provide grants to states if they adopt the voluntary standards and alter teacher certification criteria in order to meet these standards. Additional funds would be provided as students improve in these fields. The bill has yet to advance in either the House or Senate
The Senate went straight to work on climate legislation after the House passed the American Clean Energy Security Act (H.R. 2454) on June 26, examining familiar sticking points such as the impact of legislation on the American economy, particularly agriculture, and how allowances will be distributed and proceeds utilized. Senate Majority Leader Harry Reid (D-NV)has asked committees with jurisdiction to report out climate bills by late September, signaling another flurry of activity to come in the fall.
Members of the Obama Administration lent their support to efforts to enact legislation at a July 7 hearing of the Committee on Environment and Public Works (EPW) and July 22 Committee on Agriculture, Nutrition, and Forestry hearing. DOE Secretary Steven Chu, EPA Administrator Lisa Jackson, USDA Secretary Tom Vilsack, and Interior Secretary Ken Salazar urged the Senate to enact a bill that would reduce foreign dependence on energy, create green jobs, and protect future generations of Americans from the impacts of climate change.
Members of EPW and Agriculture Committees examined the effect of climate mitigation policy on the agricultural sector, a key sticking point in the House discussions. At a July 14 EPW hearing, minority members claimed that H.R. 2454 would increase costs for farmers, but most witnesses disputed this sentiment. Bill Hohenstein from the USDA and Bill Krupp from the Environmental Defense Fund testified that farmers, through an offset program, stand to profit from climate change legislation. Witnesses at both the July 14 EPW and the July 22 Agriculture Committee hearing noted that the agriculture and forestry sectors, with proper incentives, could sequester 20 percent of all U.S. greenhouse gases.
In a July 8 hearing, the Senate Committee on Finance examined the international trade considerations of a climate change bill as members seek to protect U.S. competitiveness. Witnesses recommended short-term options, such as free allocation of carbon permits to vulnerable industries, to address U.S. competitiveness concerns. However, witnesses emphasized that the best solution to reduce carbon emissions and protect U.S. industries would come through an international, multilateral agreement. Members of the Committee and witnesses expressed serious concern over border measures such as border tax adjustments, which could solicit retaliation and trade sanctions from other countries. Witnesses also warned that poorly designed border measures have the potential to violate World Trade Organization rules. President Obama has cautioned against the "protectionist" border measures included in the H.R. 2454, which would tax countries who do not take steps to reduce carbon emissions. However, a border tax appealed to ten Senate Democrats who sent a letter to President Obama in early August urging the inclusion of measures to protect domestic manufacturing, including a border adjustment mechanism.
The EPW Committee examined competitiveness from a different angle during a July 16 hearing that examined the ways that climate mitigation efforts could lead to new business ventures. John Doerr, a partner at Kleiner Perkins Caufield & Byers, testified that a cap on emissions is needed for firms to invest in new energy technologies and spur domestic production of these technologies. The current lack of a climate policy that would encourage these investments, he said, is "stifling American competitiveness." In contrast, Harry C. Alford, president and CEO, National Black Chamber of Commerce, testified on the results of a new study that showed climate legislation will cost 2.5 million jobs.
The Finance Committee also examined how to distribute allowances and use proceeds during an August 4 hearing. Members examined which scenarios, ranging from full auction to free allocation of all permits, would best protect consumers from price increases while ensuring that carbon reduction targets are met. Members also examined whether a "price collar" - a minimum and maximum allowance price - would provide greater cost certainty and therefore lower costs to businesses by reducing volatility.
Senator Kerry (D-MA) closed the hearing by noting that the alternative to cap-and-trade is not the absence of a climate policy but rather EPA regulation of greenhouse gas emissions, and urged companies to work with the Senate to develop legislation.
-- Phillip Chalker, Samantha Pearlman, and Kasey White
Health care reform continues to grab headlines this month, providing a share of the spotlight to efforts to create a regulatory pathway for generic biologic drugs. Members of Congress are debating the amount of data protection necessary to spur innovation while lowering the cost of biologic drugs for patients.
Biologic drugs are the fastest growing and most expensive element of prescription drug costs in the United States; brand-name biologics can run from $48,000 to $120,000 a year.
Biologic drugs are made from living organisms or in living cells and are much more structurally complex and environmentally sensitive than small-molecule pharmaceuticals. A biologic drug is often unique to the specific processes used to produce it. To date, it is extremely difficult to produce an exact copy of a biologic drug, hence the rise of "biosimilar" drugs or follow-on biologics.
At issue in the biologics debate is the length of a data exclusivity period. Data exclusivity, which is separate from patent protection, is the protection of clinical test data that is provided to the Federal Drug Administration (FDA) for the approval process. Under the 1984 Hatch-Waxman Act, generic drug applicants are not required to duplicate the clinical testing of drugs already approved by the FDA. Applicants only need to show that the generic drug is chemically the same as the original drug and can use the clinical test data from the original drug for this process once its protections expire.
Rep. Anna Eshoo (D-CA) has introduced the Pathway for Biosimilars Act (H.R. 1548), which provides 12 years of data exclusivity to brand-name biologic drug companies and currently has 142 cosponsors. At a July 14 House Judiciary Committee hearing, representatives from the Biotechnology Industry Organization, the National Venture Capital Association, and the American Intellectual Property Law Association backed Rep. Eshoo's bill. Witnesses testified that complexity and loopholes in the patent system require a longer data exclusivity period as a "necessary backstop" to ensure that novel drugs are protected from competition and innovation is encouraged. In addition, because minute differences in the structure of a biologic can sometimes cause major differences in the efficacy of the drug, BIO and other groups believe that they should not be approved without additional clinical testing.
Also present at the hearing were opponents of a long data exclusivity period. Bruce Leicher of Momenta Pharmaceuticals testified that a longer exclusivity period will slow innovation and provide a disincentive to companies to create true generic replicas instead of mere biosimilars. Patient advocacy groups stressed that a long data exclusivity period will hinder the creation of the generic biologic market and subsequently the creation of cheaper alternatives to name-brand drugs.
Rep. Henry Waxman (D-CA) has introduced the Promoting Innovation and Access to Life-Saving MedicineAct (H.R. 1427), which calls for 5 years of exclusivity and is supported by the Generic Pharmaceutical Association, Consumers Union, AARP, and AFL-CIO. Waxman's bill models the current generic pathway for small molecule drugs, which have a 5 year data exclusivity period. Both H.R. 1548 and H.R. 1427 have been referred to the House Energy and Commerce Committee and the House Judiciary Committee.
In the Senate, a long data exclusivity period has won approval from the Health, Education, Labor and Pensions Committee. The Committee voted 16-7 to approve an amendment by Sens. Orrin Hatch (R-UT) and Mike Enzi (R-WY) that would grant 12 years of exclusivity to brand-name biologics as part of debate on The Affordable Health Choices Act, which passed the committee on July 15.
The Executive Branch is examining the issue as well. The FTC released a report last month that states a data exclusivity period is not necessary at all. The Obama Administration has announced its support of a 7-year period, a compromise between the sides.
Any legislation for follow-on biologics is expected to be incorporated into a healthcare reform bill, which the House and Senate plan to finalize this fall.
The Senate Committee on Homeland Security and Governmental Affairs reported out The Whistleblower Protection Enhancement Act of 2009 (S.372), sponsored by Sen. Daniel Akaka (D-HI), on July 29. The House version of the bill (H.R. 1507) to expand whistleblower protections, which is sponsored by Rep. Chris Van Hollen (D-MD), was the subject of a May 14th House Government Oversight and Reform Committee hearing, but has not advanced further.
Both pieces of legislation would strengthen existing protections for federal employees who point out waste, fraud and abuse in government. In cases where whistleblowers could or have come forward the bill would prohibit the implementation of nondisclosure policies, employee investigations or revocation of security clearances. The bills would loosen evidentiary standards needed to bring about a review of whistleblower disclosures and increase the amount of compensatory damages that can be sought by a whistleblower.
Of interest to the scientific community, the bills would provide protection to individuals that report the alteration, misrepresentation, or suppression of research, analysis, or technical information and to individuals who disclose censorship by federal agencies that would violate law or cause "gross mismanagement, waste, abuse of authority or that poses a substantial and specific danger to public health or safety."
If both the Senate and the House pass their respective bills, the major area of contention in conference would surround judicial review. Some members of the Senate were apprehensive to provide the same clear guidelines that the House bill provides on how whistleblowers can seek judicial review. Furthermore, the House bill makes it easier to challenge the Merit Systems Protection Board (MSPB)'s rulings by obtaining a judicial review and, unlike its Senate counterpart, allows for a jury trial if requested by either party. Both chambers maintain exemptions from jury trials for the intelligence communities.
As the 111th Congress takes a break for the August recess, multiple bills to advance science, technology, engineering, and math (STEM) education sit waiting for their return.
The STEM Coordination Act (H.R.1709, S.1210), sponsored by House Science and Technology Committee Chairman Bart Gordon (D-TN) and Sen. Edward Kaufman (D-DE), would establish a committee within the Office of Science and Technology Policy National Science and Technology Council (NSTC) to synchronize STEM education efforts across federal agencies. Key agencies with active STEM education initiatives impacted by the bill include the National Science Foundation (NSF), Department of Energy, National Aeronautics and Space Administration, National Oceanic and Atmospheric Administration, and the Department of Education.
The legislation, which passed the House and now sits in the Senate Committee on Commerce, Science, and Transportation, calls for the new NSTC STEM Committee to evaluate all federal STEM education programs every five years. The evaluation would establish long and short-term goals, create metrics to assess the new goals, and review past efforts to determine program effectiveness. All federally-sponsored STEM education activities would be inventoried.
Similar to the STEM Coordination Act is the Enhancing Science, Technology, Engineering, and Mathematics Education Act of 2009 (H.R. 2710), sponsored by Rep. Mike Honda (D-CA). In addition to creating an NSTC STEM Education Committee similar to Gordon's bill, H.R. 2710 would require the Committee to promote efforts to improve federal and state collaboration. Furthermore, it would create an Office of STEM Education within the Department of Education to coordinate and evaluate STEM education efforts within the Department. The bill was referred to the House Committee on Science and Technology Subcommittee on Research and Science Education.
To further examine methods of collaboration and coordination, the Research and Science Education Subcommittee held a hearing that showcased partnerships in Chicago that improved science education, a diverse urban district where 85 percent of students come from low-income families. Michael Lach, officer of teaching and learning for the Chicago Public School system concluded that success depended on "the assistance and partnership of others - the local community groups, colleges and universities, museums and laboratories as well as the federal government." Examples of partnerships included an NSF grant to create a program at local universities to improve teacher education courses in science and mathematics; a series of course curriculum materials (e.g., textbooks, assessments, and professional development workshops) developed by the University of Chicago for the local schools to use to enhance STEM education in the classroom and the district created a series of after-school clubs through the local science museums and botanical gardens to enrich and retain students' interest in key scientific disciplines.
Though Lach noted that they still had much more to do, he emphasized that the success of their partnerships to date depended on a coherent strategy and, most importantly, centralization of the system. He stated that "systems that foster innovation and entrepreneurship push decisions and resources closest to schools and classrooms, and when they are coupled with strong accountability systems, local communities can easily gauge success."
Quick status reports to keep you up to date on recent S&T bills and hearings.
On July 30 the House passed a major food safety bill by a vote of 283-142. The Food Safety Enhancement Act (H.R. 2749) would raise money for the Food and Drug Administration (FDA) through inspection fees and give the FDA broad new powers such as mandatory food recall authority. It would mandate several changes in food facility practices and require the government to devise "science-based standards" to minimize food hazards. The bill has yet to go through the Senate.
Because House and Senate conferees were not able to reach consensus before the July 31 expiration of the authorization for the Small Business Innovation Research and Small Business Technology Transfer programs, President Obama signed legislation (S. 1513) temporarily extending the programs' authorization for two months. As reported in the June issue, the key sticking point has been whether the percentage set-aside for SBIR/SBTT from R&D programs should be increased or remain the same.
The Senate Commerce, Science, and Transportation Committee held a July 28 hearing to examine legislation and methods to improve hurricane prediction, modeling, forecasting, and response systems. Sens. Nelson (D-FL) and Martinez (R-FL) have introduced a "six pack" of hurricane-related legislation that includes a research component: The National Hurricane Research Initiative (S.1485). Members also discussed Sen. Hutchison's Weather Mitigation Research and Development Policy Authorization Act (S. 601).
The House Science and Technology Committee approved several bills to advance R&D at the Department of Energy on July 29. Sponsored by Rep. Paul Tonko (D-NY), H.R.3029 authorizes $65 million a year from 2011 to 2014 for increased research, development, and demonstration (RD&D) to increase efficiency of gas turbines. Also sponsored by Rep. Tonko, the Wind Energy Research and Development Act of 2009 (H.R.3165) authorizes $200 million for RD&D to improve efficiency, reliability, and capacity of wind turbines while reducing the cost of construction, maintenance and generation. H.R.3247, sponsored by Brian Baird (D-WA), establishes a social and behavioral sciences research program at the Department of Energy and authorizes $10 million annually from 2010 to 2015 for a research program to identify social and behavioral factors that influence energy consumption and adoption of new energy technologies. The Committee also approved the Advanced Vehicle Technology Act of 2009 (H.R. 3246) sponsored by Rep. Gary Peters (D-MI). The bill authorizes more than $2.8 billion in R&D to improve transportation efficiency.
On June 30, EPA granted California's Clean Air Act waiver request, enabling the state to enforce its greenhouse gas emissions standards for new motor vehicles. The Bush Administration had denied the waiver (requested by the state in 2005) in March 2008, even though EPA's legal council suggested the denial would fail if challenged in court. The waiver is largely symbolic, as President Obama announced national auto emission standards that match California's proposed standards on May 19.
EPA has extended the comment period for its proposed rule to implement the national Renewable Fuel Standard program for an additional 60 days until September 25, 2009. The proposed rule, which was mandated by the 2007 Energy Bill, has received much scrutiny for the methods used to calculate greenhouse gas emissions of biofuels.
NOAA announced a final rule that will prevent the harvesting of krill, which are a key part of the oceanic food web, within 200 miles of the coasts of California, Oregon and Washington.
AAAS CEO Testifies on Gender Gap in Science AAAS CEO Alan Leshner testified before the House Science and Technology Committee's Research and Science Education Subcommittee last week on attracting and retaining women and girls in science, technology, engineering and mathematics. Though progress has been made in recent decades, it has been uneven. "The [gender] gap is real; the gap persists," he said, detailing several examples in his prepared remarks.
AAAS Comments on Objectivity in Research
On July 7, AAAS commented on an Advance Notice of Proposed Rulemaking pertaining to objectivity in research, published by the Department of Health and Human Services in the Federal Register on May 8, 2009.
Pew/AAAS Study: While Public Praises Scientists, Scientists Fault Public, Media
A July 9, 2009 report by the Pew Research Center for the People & the Press in collaboration with the American Association for the Advancement of Science (AAAS) found that the majority of Americans think "that science has had a positive effect on society." To read more about scientists' and the general public's perception of science go to http://www.aaas.org/news/releases/2009/0709pew.shtml.
Scientists are still pouring over data captured by the Phoenix Mars Lander, and finding several indications of water on the planet, a key criteria for habitability. Data from the Mars Lander shows that ice lies beneath soil at the Martian North Pole, the ice was once liquid and physically modified the soil, and the Martian soil absorbs water vapor from the air at night.
Smith, P.H., et al., "H2O at the Phoenix Landing Site," Science, 3 July 2009: Vol. 325. no. 5936, pp. 105.
