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Archived News and Announcements

Current News and Announcements

US EPA Cancels Green Chemistry Grant Applications
Submitted on Apr 17, 2012

On Friday, April 6, the US Environmental Protection Agency (US EPA) announced that the agency was cancelling grant applications for a $20 million four-year green chemistry program. The announcement came three weeks before the April 25 deadline for the grant proposals. The grants would have funded two new centers, Centers for Material Life Cycle Safety and the Centers for Sustainable Molecular Design, and would have drawn together scientists from a range of disciplines to develop improved methods for the design of next generation chemicals. No explanation was given by US EPA for the cancellation.



Institute of Medicine Report Calls for Strong Regulatory System Abroad for Food and Drugs
Submitted on Apr 17, 2012

A report that was issued in April 2012, recommends that the US Food and Drug Administration (US FDA) work closely with regulatory agencies and international organization to ensure that only safe food and medical products reach American consumers. According to the report, “The FDA’s traditional method of ensuring product safety—periodic inspections at factories and 300 ports of entry is impractical when 20 million types of FDA-regulated goods arrive from more than 300,000 factories in 150 different countries.” The report acknowledges that even though US FDA created a strategic plan that broadens the agencies safety focus for imports, more needs to be done. The report recommends that “because everyone has a stake in product safety, everyone needs to take action to build regulatory systems.” For more information, see the full report.



NIH Testifies on Impact of Budget Cuts before Senate Appropriations Subcommittee
Submitted on Apr 17, 2012

Francis Collins, Director of the National Institutes of Health (NIH), testified in late March about the impact of proposed budget cuts on the NIH before the Senate Labor-HHS-Education Appropriations Subcommittee. He reported that the proposed budget cuts could cost a $2.4 billion loss for NIH and 2,300 fewer research project grants.



Institute of Medicine Hosts Workshop on Health Impact Assessment of Shale Gas Extraction
Submitted on Mar 28, 2012

The Institute of Medicine (IOM) is hosting a workshop on April 30–May 1 on the Health Impact Assessment of New Energy Sources: Shale Gas Extraction at the House of Sweden in Washington, DC. The goals and objectives for the workshop include using shale gas extraction as a case study to explore the health impacts of emerging energy technologies, applying health impact assessment to identify ways to mitigate adverse health effects, identifying direct and indirect health risks and solutions from a cradle to grave approach, identifying vulnerable populations and stakeholders, describing research questions, data, sources, data gaps, and determining how to address uncertainty. Speakers for the all-day session include several SOT members including Christopher Portier, Aubrey Miller, Bernard Goldstein, Jennifer Orme-Zavaleta, George Gray, and Linda Birnbaum.



Training Seminar and Financial Aid for SOT Investigator Applicants
Submitted on Mar 28, 2012

The National Institutes of Health (NIH) is sponsoring a seminar on Program Funding and Grants Administration on Thursday–Friday, June 21–22. SOT will provide up to 2 travel awards of $500 each to supplement institutional funding for early investigators to attend this NIH Regional Seminar. NIH offers these comprehensive workshops about the NIH grants process and policies, including topics such as peer review, grant writing for success, pre-award and post-award issues for administrators and investigators, compliance, and how to interact electronically with NIH, as well as the opportunity to meet and discuss grants issues with over 30 HHS and NIH officials and to network. The early registration is available through March 26. Presentations are targeted toward attendees new to the NIH grants process. However, there are sessions for more experienced attendees wanting to hear the latest news that NIH senior leadership and policy officials have to offer. To apply, go to the seminar website and submit the application form.



In a recent ruling, the US Supreme Court declared that a company’s patent...
Submitted on Mar 28, 2012

In a recent ruling, the US Supreme Court declared that a company’s patent on a medical-testing process is invalid. According to the ruling, “Patent claims that describe natural phenomena are not patent-eligible, and the diagnostic procedure outlined in the patents at risk, “adds nothing to the laws of nature that is not already present when the steps are considered separately.” For more information about the ruling, see the full Supreme Court Ruling.



US EPA Proposes New Limits of Potentially Hazardous Chemicals
Submitted on Mar 28, 2012

The US Environmental Protection Agency is proposing a new set of regulations mandating that all companies report all new uses of five potentially harmful including polybrominated diphenylethers (PBDEs), benzidine dyes, a short chain chlorinated paraffin, hexabromocyclododecane (HBCFD), and phthalate di-n-pentyl phthalate (DnPP). The proposal falls under the significant new use rules (SNUR) of the Toxic Substances Control Act. The proposal would require that anyone who intends to manufacture, import, or process any of the chemicals for an activity that is designated as a significant new use must submit notification to US EPA at least 90 days before beginning the activity For more information about this proposed rule, go to the US EPA Existing Chemicals website.



Poison Control Week: March 18-24: Ways to Prevent Poisonings
Submitted on Mar 26, 2012

In recognition of Poison Control Week, the US EPA and other federal agencies are offering the following advice about preventing poisonings:

  • Post the Poison Control Centers’ national helpline number (800.222.1222) near your phone. Program the number into your phone’s address book or redial feature.
  • Read the product label first and follow the directions to the letter.
  • Use the safest possible cleaning products. Look for the Design for the Environment (FdE) label on products.
  • Never leave products unattended when you are using them.
  • Re-close products if interrupted during application.
  • Use child-resistant packaging properly by closing the container tightly after use.
  • Remove children, pets, and toys before applying pesticides. Follow label directions to determine when children and pets can re-enter the area that has been treated.
  • Never use illegal pesticides.

More information about poisoning prevention  in your home is available on the US EPA Pesticide Poison Prevention website.



US EPA Releases Tool to Provide Public with Information about Water Pollutants
Submitted on Feb 20, 2012

The US Environmental Protection Agency (US EPA) has recently released a tool that gives the public information about pollutants that are released into local waterways. The tool, Discharge Monitoring Report (DMR) Pollutant Loading Tool, brings millions of records and maps together by local area and shows this information by local area, watershed, company, industry sector and pollutant. A link to the new tool can be found on the US EPA’s website.



The National Science Foundation is accepting nominations for the 2012 National Medal of Science.
Submitted on Feb 20, 2012

The National Science Foundation is accepting nominations for the 2012 National Medal of Science. The National Medals of Science are awarded by the President of the United States to individuals deserving of special recognition by reason of outstanding cumulative contributions to knowledge in the biological, physical, mathematical, engineering or behavioral or social sciences. Self-nominations are not eligible. Deceased nominees are eligible for award after the fifth anniversary of the day of death. A complete nomination consists of a nomination form and three to five letters of support. The nomination package should include a list of no more than ten publications and patents, each accompanied by a brief explanation of their significance. All nominations and letters should be sent electronically and all nominations are due by March 31, 2012. A committee of 12 scientists and engineers is appointed by the President to evaluate the nominees for the Award. Since it was established by the 86th Congress in 1959, a total of 468 scientists and engineers have received this award including SOT Members Bruce Ames, Bernard Brodie and Gertrude Elion. For more information see the National Medal of Science website.



The National Institutes of Health (NIH) budget for FY2013
Submitted on Feb 20, 2012

The National Institutes of Health (NIH) budget for FY2013 that President Obama released on Monday, February 13, sets the funding level at $30.623 billion. Of that total, the Eunice Kennedy Shrive National Institute of Child Health and Human Development would receive a total of $1.32 billion, which represents an increase of .775 million dollars over the FY 2012 enactment level. The National Institute of Environmental Health Sciences would receive $684.030 million which represents 725 thousand dollars less than the approved FY2012 level. For more information, see the additional NIH budget documents.



SOT Member Bernard Goldstein Testifies on the Public Health Implications of Unconventional Gas Drilling Before House Subcommittee
Submitted on Feb 06, 2012

Bernard D. Goldstein, longtime SOT member and Professor Emeritus of Environmental and Occupational Health and Dean Emeritus of the University of Pittsburg Graduate School of Public Health, presented testimony Wednesday, February 1, 2012 before the House Energy and Environment Subcommittee on Science, Space and Technology on US EPA Hydraulic Fracturing Research.

Goldstein noted that the overall theme of his testimony is that, “It is in the nation’s and in industry’s best interests to maximize the yield of natural gas while minimizing the short-term and long-term environmental and public health costs,” and urged the committee to address the possibility of adverse public health impacts associated with unconventional gas drilling. Pointing to research he conducted of those who testified against drilling to the Natural Gas Subcommittee of the Secretary of Energy’s Scientific Advisory Board, he noted that about two-thirds cited health concerns. He went on to say that the public’s concerns about potential health effects is legitimate, noting that there are many agents of toxicological concern in the fracking mixture and “many other agents about which we know too little.” He also pointed out that as far as he knows, there is no study underway which thoroughly explores exposures and outcomes related to unconventional gas drilling activities. He said, based on his experience as a doctor and a toxicologist, “there is genuine cause for concern and the current lack of almost any support for research directly related to the health effects of unconventional gas drilling is shortsighted and counterproductive.” He went on to urge Congress to update certain mixtures studies by providing funding to apply modern toxicological advances to the chemical mixtures that are being used or result from hydraulic fracturing.

Referring to an analysis that he and two other colleagues produced for publication in the Environmental Health Perspectives, he noted that of the 52 members appointed to two state commissions and the federal government, they could not identify a single person with a background in any health field. He also pointed out that the Department of Health and Human Services wasn’t among the three federal agencies specified to be involved in the ongoing federal effort. He said, “Ignoring the public health implications of unconventional natural gas extraction is not going to work.” He concluded by saying “It is in the best interest of the nation to invest in understanding the potential adverse health consequences of this activity. The most cost-effective time, and in fact, the only cost-effective time to make this investment is now rather than to wait until the inevitable clamor for such research when diseases begin to appear that are associated with natural gas drilling activities.”



Paul Anastas Leaving US EPA to Return to Yale
Submitted on Jan 18, 2012

Paul Anastas, PhD, Assistant Administrator for the US Environmental Protection Agency (US EPA) Office of Research and Development (ORD) and the Science Advisor to the Agency is leaving the US EPA in mid-February to return to Yale Universisty. Dr. Anastas is known widely as the “Father of Green Chemistry” for his groundbreaking research on the design, manufacture, and use of minimally-toxic, environmentally-friendly chemicals.



NIH Responds to IOM’s Report on the Use of Chimpanzees in Biomedical and Behavioral Research
Submitted on Dec 16, 2011

Dr. Frances Collins met with the press on December 15 and announced that he will not issue any new awards for research involving the use of chimpanzees until the Institute has established new processes that incorporate recommendations from the Institute of Medicine’s Committee on the Use of Chimpanzees in Biomedical and Behavioral Research. The report, which was issued in response to a mandated request from Congress, places restrict rules for using apes in research. During his session with the press, Dr. Collins said, “NIH is in the process of developing a complete plan for the implementation of the IOM’s guiding principles and criteria. I will be assembling a working group within the NIH Council of Councils to provide advice on the implementation of the recommendations and to consider the size and placement of the active and inactive populations of NIH-owned or –supported chimpanzees.”

For more information about the IOM report go to the IOM Web site.


House and Senate Conferees Working to Conference Package for Nine Appropriations Bills
Submitted on Dec 12, 2011

The House and Senate held a joint conference committee on Thursday, December 8 and appointed conferees to negotiate a final appropriations package for nine appropriations bill, including the Labor, HHS and Education Appropriations bill which contains funding for the National Institutes of Health and the National Institute of Environmental Health Sciences. These federal agencies are currently operating under a Continuing Resolution that expires December 16, 2011.



White House Releases Final Strategy for Reversing Deterioration of Gulf Ecosystem
Submitted on Dec 12, 2011

A Task Force established by the Obama Administration released a final report for long term ecosystem restoration of the Gulf Coast following extensive input by states, tribes, federal agencies, local governments, and thousands of involved citizens. The priorities that the Task Force has set forth include the following:

  • Stopping the loss of critical wetlands, sand barriers and beaches
  • Reducing the flow of excess nutrients into the Gulf
  • Enhancing the resiliency among coastal communities
The release of the report also triggers the implementation phase that includes the availability of $50 million in assistance from the US Department of Agriculture’s Natural Resources Conservation Service to help agricultural producers in seven Gulf Coast river basins improve water quality, increase water conservation and enhance wildlife habitat. 
For more information see the Gulf Coast Task Force website.



Toxicity Testing in the Twenty-First Century (Tox21) Begins Chemical Testing on 10,000 Chemicals
Submitted on Dec 12, 2011

The National Institutes of Health (NIH), the US Environmental Protection Agency (US EPA) and the US Food and Drug Administration are working together and have released a high-speed robotic screening system, that is designed to improve how chemicals are tested in the United States. The testing for potential toxicity began yesterday on 10,000 compounds that cover a wide variety of classifications, and include consumer products, food additives, chemicals found in industrial processes, and human and veterinary drugs. A complete list of the compounds is publicly available on the US EPA website. Other NIH partners include the National Toxicology Program (NTP), administered by the National Institute of Environmental Health Sciences (NIEHS), and the NIH Chemical Genomics Center, part of the NIH Center for Translational Therapeutics, housed at the National Human Genome Research Institute (NHGRI). For more information see the full NIH news article.



NIH Opens Application Process for the 2012 Director’s Early Independence Awards
Submitted on Nov 21, 2011

SOT is pleased to announce that the National Institutes of Health (NIH) is taking applications for the 2012 Director’s Early Independence Awards. Eligibility for the award includes the following:

  • For junior investigators wishing to “skip the postdoc” and immediately begin independent research.
  • Eligible candidates must be within one year of receipt of terminal research degree or completion of clinical residency.
  • Only a maximum of two applications per institution (as defined by unique DUNS number) are permitted.
  • All areas of research relevant to the mission of NIH are welcome.
  • Budgets may be up to $250,000 in direct costs per year for up to five years.

The deadline for submitting Early Independence Award applications is January 30, 2012 and Letters of Intent are due by December 30, 2011. See the instructions in RFA-RM-11-007. Additional information, including Frequently Asked Questions about the Early Independence Award Program is available on the Early Independence website. Send questions to earlyindependence@mail.nih.gov.

The NIH Common Fund (formerly the NIH Roadmap) encourages collaboration and supports a series of exceptionally high impact, trans-NIH programs. These programs are supported by the Common Fund and managed by the NIH Office of the Director in partnership with the various NIH Institutes, Centers, and Offices. Additional information about the NIH Common Fund can be found on the Common Fund website.

The NIH is the primary US federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit the NIH website.



NTP Seeks Public Input on the Process for Reviewing the Report on Carcinogens
Submitted on Nov 21, 2011

The National Toxicology Program is hosting a public listening session as part of the review process for the Report on Carcinogens (RoC). The listening session will be held November 29 from 1 pm–7 pm EST. Individuals who wish to participate in the listening session as either speakers or observers must register by November 21, 2011, on the NTP RoC website.

The RoC is a science-based, public health document, required by Congress to be published every two years (Public Health Services Act sec. 301(b)(4), 42 U.S.C. 241(b)(4)). The RoC provides information on substances that may pose a hazard to human health by virtue of their carcinogenicity (for more information see the NTP RoC website.

Substances are listed in the report as either known or reasonably anticipated human carcinogens. The NTP prepares the RoC on behalf of the Secretary of Health and Human Services. The 12th RoC was published in June 2011.

The NTP followed an established process for the review of substances for the 12th RoC. The NTP is proposing changes to the review process for listing substances in the 13th RoC to enhance transparency and efficiency and to enable the NTP to publish the RoC in a timelier manner. The NTP also seeks to maintain critical elements of the existing process including external scientific and public involvement, scientific rigor, and external peer review. The proposed RoC review process is available on the NTP RoC Web site.



NIH’s Collins Announces Creation of New Translational Institute: Impacts Future of NCRR
Submitted on Nov 03, 2011

Francis S. Collins, M.D., Ph.D., Director of the National Institutes of Health (NIH), has announced the establishment of an Institute for Advancing Translational Sciences that will affect other NIH areas, such as the National Center for Research Resources (NCRR). At the 2011 SOT Annual Meeting in Washington, D.C., Dr. Collins will deliver the Plenary Opening Lecture, “NIH Vision,” on Monday, March 7, 8:00 AM–9:00 AM. He will describe plans for the future of NIH. Dr. Collins is a physician-geneticist noted for his landmark discoveries of disease genes and his leadership of the Human Genome Project, which successfully completed the first sequence of the human DNA instruction book in 2003. For more information about the translational institute, see the full article and interview on the Science Insider website.


SOT Releases Paper on the Deepwater Horizon Oil Spill
Submitted on Nov 01, 2011

The SOT Council is pleased to announce the release of an issue statement on the Deepwater Horizon Oil Spill, which was the largest accidental release of crude oil in modern history. Issue Statements are short and balanced presentations of the science and related issues underlying an area of relevance to SOT.


SOT’s David Eaton Elected a Member of the Institute of Medicine
Submitted on Oct 20, 2011

David Eaton, longtime SOT member and SOT past president (2001–2002) has been elected a member of the Institute of Medicine (IOM). Eaton is well known for his research on toxins in the environment. He maintains his own active research and teaching program at the University of Washington where he is Professor and Director of the Center for Ecogenetics and Environmental Health, and National Institute of Environmental Health Sciences Center for Excellence at the University of Washington. He is also Associate Dean for Research in the School of Public Health and Associate Vice Provost for Research for the University of Washington.

Eaton received his Ph.D. in pharmacology from the University of Kansas Medical Center in 1978. He then received a fellowship at the University where he was a postdoctoral student. In 1979, he joined the faculty of the University of Washington. From 1983–1990, he served as Toxicology Program Director in the Department of Environmental Health and was named Associate Chairman of the Department in 1990.

Regarding the new inductees, IOM President Harvey V. Fineberg said, “Each of these new members stands out as a professional whose research, knowledge, and skills have significantly advanced health and medicine, and their achievements are an inspiration. The Institute of Medicine is greatly enriched by the addition of our newly elected colleagues.” New members are elected by current active members through a highly selective process that recognizes individuals who have made major contributions to the advancement of the medical sciences, health care, and public health. Election to the Institute is considered one of the highest honors in the fields of health and medicine. Membership recognizes individuals who have demonstrated outstanding professional achievement and commitment to service.

View additional distinguished SOT Members.



SOT Collaborates with Executive Branch
Submitted on Oct 12, 2011

For the past several years, SOT has been working to find ways to collaborate more closely with various government agencies with the goal of helping those institutions fulfill their missions. After much effort on the part of SOT Council, the Society has established solid working relationships with National Institutes of Health, the US Food and Drug Administration, the US Environmental Protection Agency, the National Institute for Occupational Safety and Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the Agency for Toxic Substances and Disease Registry. Among other accomplishments, SOT has secured a Letter of Understanding with the US Environmental Protection Agency and a Memorandum of Understanding with the National Institute of Occupational Safety and Health.


SOT Member Recipient of Government’s Highest Honor
Submitted on Oct 03, 2011

Dr. David Reif, SOT Member and a scientist at the U.S. Environmental Protection Agency (U.S. EPA) is one of two recipients of this year’s Presidential Early Career Award for Scientists and Engineers (PECASE). The award is the highest honor bestowed by the U.S. government on outstanding science and engineering professionals in the early stages of their independent research careers. Dr. Reif was nominated for developing tools for prioritizing and profiling chemicals for potential toxicity to human health and the environment, as well as studying the various subsets of childhood asthma in order to develop more personalized diagnoses, management and treatment of the disease.

The award was instituted by President Clinton in February 1996 to honor and support the extraordinary achievements of young professionals at the outset of their independent research careers in the field of science and technology. The Presidential Award embodies the high priority placed by the government on maintaining the leadership position of the United States in science by producing outstanding scientists and engineers who will broadly advance science and the missions important to the participating agencies.



National Research Council Hosts Workshop on New Toxicological Testing Methods and Tools
Submitted on Oct 03, 2011

On September 20–21, 2011, the National Research Council hosted a day and half workshop entitled, “Applying 21st Century Toxicology to Green Chemical and Material Design.” The workshop was designed to bring chemists, toxicologists, industry sustainability and executive officers and other stakeholders together to define common goals, identify knowledge gaps and promote applied research aimed at expediting and targeting the application of new technology to the emerging field of green chemistry with its life cycle approach. To view more information, visit the workshop Web site. You will to log-in and once you have completed this, you can view the taped session.



One Congresswoman Talks About the Importance of Biomedical Research
Submitted on Oct 03, 2011

Rep. Rosa DeLauro (D-Conn) has done a great favor for U.S. scientists everywhere by publishing a story about herself in the Special Report section of The Hill, a congressional newspaper that publishes daily when Congress is in session. Entitled, “No Such Thing as a One-Year Cut for Medical Researchers.” Rep. DeLauro talks about surviving ovarian cancer notes that she is alive today “by the grace of God and the innovations of biomedical research.”

Rep. DeLauro points out that “There is no one year cut to medical research.” She states that every research grant awarded results in seven new jobs. A one year cut, according to Rep. DeLauro “can turn an entire group of researchers away from the field and patients will never see the rewards that might have been.”

It’s our turn now to echo Rep. DeLauro’s story to every Member of Congress, whether they read her story or not. Please consider drafting a letter to your Member of Congress and give them a link to The Hill story. Let him/her know what research you’re working on and how important continued, adequate funding of medical research is to the well being of other Americans. You can view the full article on The Hill’s Web site.



New HESI Committee on Safer, Sustainable Alternatives
Submitted on Sep 23, 2011

Based on the results of a survey of its multi-sector, tripartite constituency, the ILSI Health and Environmental Sciences Institute (HESI) will convene a new committee on “Frameworks for Alternative Chemical Assessment and Selection of Safer, Sustainable Alternatives.” The committee plans to develop a set of principles to guide comparison of alternative chemicals and build a framework for selection of appropriate alternatives based on performance, toxicity profile, and life-cycle assessment parameters. Broad agreement and endorsement by key stakeholders is a primary objective. To volunteer or to obtain more information about the project, contact Nancy G. Doerrer, M.S., Associate Director.


US FDA Releases Five-Year Plan to Enhance Rare Disease Program
Submitted on Sep 22, 2011

The US Food and Drug Administration (US FDA) recently released a five-year plan that is expected to enhance the Rare Disease program of the US FDA’s Center for Drug Evaluation and Research. Under the new plan, pharmaceutical and biotech companies will receive specialized training on the development of drug for rare or orphan diseases and improve its outreach to rate disease patient organizations. A total of five new positions will be added and US FDA plans to revamp the monitoring and evaluation process of the program. US FDA also intends to hold a public meeting to seek input on the US FDA’s draft recommendations.


Richard Nakamura Named Acting Director of Center for Scientific Review
Submitted on Sep 22, 2011

Richard Nakamura, Ph.D., has become Acting Director of the Center for Scientific Review (CSR) at the National Institutes of Health. Dr. Nakamura will replace Toni Scarpa, who resigned September 2, 2011. Dr. Nakamura has spent 35 years at the National Institute of Mental Health (NIMH), where he has served as both Scientific Director and Deputy Director of the Institute, and as Acting Director from 2001 to 2002.


CSR Recruiting for Early Career Reviewer Program
Submitted on Sep 22, 2011

The National Institutes of Health’s (NIH) Center for Scientific Review (CSR) is now recruiting researchers into a new Early Career Reviewer (ECR) Program. Researchers will participate in a CSR study section meeting once a year for up to two years and have a limited role, serving as the third reviewer on two NIH grant applications each time. In selecting researchers for the program, CSR will consider researchers who have an active research program, who are published in high-impact journals, and who have not reviewed for NIH in a face-to-face meeting. An ECR does not necessarily need to have NIH or equivalent funding. For more information, see the NIH CSR Web site.


Study Shows Accidental Medication Poisonings On the Rise
Submitted on Sep 22, 2011

The American Association of Poison control Centers recently released a study that shows that between 2001 and 2008 accidental medication poisonings by children aged five and under has increased by 22 percent. The majority of visits to emergency rooms (95 percent) were a result of self-ingestion and a total of 55 percent of the emergency visits involved prescription drugs. Medications that had the biggest impact were: Opioid-containing pain medications, muscle relaxants, sleeping pills, and heart pills.


SOT Celebrates Its Members
Submitted on Sep 21, 2011

To become a full member of SOT, a scientist must be recognized as the leader in the field of toxicology by his or her peers. View the several SOT members who have also earned the following scientific honors.

Institute of Medicine

The Institute of Medicine (IOM) is renowned for its research program, but it is also an honorific organization with more than 1,700 members and foreign associates who donate their time to put their knowledge and expertise to work for the nation's health. Each year, the full membership elects up to 65 new members and five foreign associates to the IOM. Members are elected for their excellence and professional achievement in a field relevant to the IOM's mission and for their willingness to participate actively in its work. These individuals represent not only the health care professions but also the natural, social, and behavioral sciences, as well as law, administration, engineering, and the humanities. For those at the top of their field, membership in the IOM reflects the height of professional achievement and commitment to service. SOT members who have been elected are:

Linda S. Birnbaum
Thomas W. Clarkson
David L. Eaton
Ronald W. Estabrook
Bernard D. Goldstein
H. Robert Horvitz
Donald R. Mattison
Roger O. McClellan
Mario Molina
Ferid Murad
Herbert L. Needleman
Kenneth Olden
Gilbert S. Omenn
Sten Orrenius (Foreign Associate Member)
Jim E. Riviere
Leona D. Samson
Bernard A. Schwetz
Takashi Sugimura
Steven R. Tannenbaum
Michael J. Welsh
Gerald N. Wogan

National Academy of Sciences

Members of the National Academy of Sciences (NAS) are composed of approximately 2,100 members and 380 foreign associates, of whom nearly 200 have won Nobel Prizes. Members and foreign associates of the Academy are elected in recognition of their distinguished and continuing achievements in original research; election to the Academy is considered one of the highest honors that can be accorded a scientist or engineer. The following SOT members are also members of the NAS:

Bruce N. Ames
John E. Casida
Allan H. Conney
Robert J. Cousins
Ronald W. Estabrook
James M. Fujimoto
Bruce D. Hammock
H. Robert Horvitz
Mario Molina
Ferid Murad
Michael J. Welsh
Gerald N. Wogan

The National Medal of Science

The National Medal of Science was created by statute in 1959, and is administered for the White House by the National Science Foundation (NSF). Awarded annually, the medal recognizes individuals who have made outstanding contributions to science and engineering. The following SOT members are recipients of this distinguished award:

Bruce N. Ames
Bernard B. Brodie
Gertrude Elion

An Order of the British Empire

The Order of the British Empire recognizes distinguished service to the arts and sciences, public services outside the Civil Service and work with charitable and welfare organizations of all kinds.

Ian Kimber

French Legion of Honor Award

The Award acknowledges the invaluable contributions scientists have made to medical research and especially his contribution to the expansion of French pharmaceutical research in the United States.

Jack Dean

Royal Swedish Academy of Sciences

The Royal Swedish Academy of Sciences is an independent organization whose overall objective is to promote the sciences and strengthen their influence in society. Among other things, the Academy seeks to be a forum where researchers can meet across subject borders to offer unique research environments, support young researchers, reward prominent contributions to research, and arrange international scientific contacts.

Sten Orrenius

American Association for the Advancement of Science

Fellow of the AAAS is an honor accorded by the American Association for the Advancement of Science (AAAS) to distinguished persons for "efforts on behalf of the advancement of science or its applications [which] are scientifically or socially distinguished." Examples of areas in which nominees may have made significant contributions are research; teaching; technology; services to professional societies; administration in academe, industry, and government; and communicating and interpreting science to the public. AAAS has awarded fellowships since 1874.

Cheryl Lyn Walker

Russian Academy of Medical Sciences

A prestigious organization that is headquartered in Moscow. The academy is composed of more than 60 research institutes and councils that span multiple areas of medicine. Election to the academy is considered the highest honor for medical scientists in Russia.

John A. Thomas


House Appropriations Committee Files Continuing Resolution with Rules Committee—Continues Funds Through November 18
Submitted on Sep 20, 2011

On September 14, the House Appropriations Committee filed a continuing resolution with the House Rules Committee to provide funding for the federal government until midnight November 18. The resolution funds the federal government at a rate of $1.043 trillion, the discretionary spending cap mandate in the Budget Control Act of 2011, which is almost $7 billion below the current year. The House and Senate are expected to take up the continuing resolution the week of September 19 because 12 regular appropriations bill for FY 2012 have yet to be enacted. The House Labor-HHS Educations Subcommittee postponed its markup of the FY 2012 spending bill which includes funds for the National Institutes of Health.


US Department of Agriculture Proposes New Requirements for Imported Dogs
Submitted on Sep 20, 2011

The US Department of Agriculture’s Animal and Plant Inspection Service is proposing regulatory changes to help ensure the welfare of dogs that are imported to the US The proposed rule would prohibit the importation of dogs from any part of the world into the continental United States or Hawaii for purposes of resale, research, or veterinary treatment, unless the dogs are in good health, have received all vaccinations and are at least six months old. Public comments on the rule must be filed by October 31, 2011.


SOT Postdocs Blog for National Postdoctoral Appreciation Week
Submitted on Sep 19, 2011

SOT Postdocs Blog for National Postdoctoral Appreciation Week—September 19–23 is National Postdoctoral Appreciation Week. SOT postdocs are sharing their thoughts through the ToXchange blog on a variety of subjects. What are some of the challenges faced by postdocs, what are their experiences like? Join the discussions!


SOT Addresses Notice Concerning Federal Employee Involvement with Non-Profit Organizations
Submitted on Sep 15, 2011

SOT filed a set of comments this summer in response to a Federal Register notice concerning federal employees’ involvement in professional societies and nonprofit organizations and co-signed a similar letter on behalf of the Scientific Liaison Coalition. The issuance of a Federal Register notice on May 3, 2011 was a response to a Memorandum that President Obama issued on March 9, 2009 on scientific integrity, which set forth six principles central to the “preservation and promotion of scientific integrity.” The Memorandum also assigned the Director of the Office of Science and Technology Policy the responsibility for ensuring the highest level of integrity in all aspects of the executive branch’s involvement with scientific and technological process.

Following the issuance of this Memorandum, John Holdren, Assistant to the President for Science and Technology and the Director of the Office of Science and Technology Policy issued a Memorandum for the Heads of the Executive Departments and Agencies on scientific integrity. In this Memorandum, Holdren provided further guidance to executive departments and agencies to implement the Administration’s policies on scientific integrity. Part IV of the Mr. Holdren’s Memorandum went further to delineate the Administration’s Open Government Initiative with the following:

Agencies should establish policies that promote and facilitate, as permitted by law, the professional development of Government scientists and engineers. Such policies should consistent with Federal ethics rules, job responsibilities, and existing agency policies regarding political appointees:

  1. Encourage publication of research findings in peer-reviewed, professional or scholarly journals.
  2. Encourage presentation of research findings at professional meetings.

SOT Responds to Government Employees Serving in Official Capacity in Nonprofit Organizations

Federal Register Notice: Office of Government Ethics

John P. Holdren Memorandum of December 17, 2010

Scientific Coalition Letter



Dr. Constantine Stratakis Appointed NICHD’s Scientific Director
Submitted on Sep 15, 2011

Dr. Constantine Stratakis has been appointed Scientific Director of the National Institute of Child Health and Human Development. Before assuming this new role, he was the Acting Scientific Director of the NICHD on July 1, 2009. Dr. Stratakis received his M.D. and Doctor of Medical Sciences degrees from the National and Capodistrian University of Athens in 1989 and 1994, respectively. He did predoctoral work at the Unit of Endocrinology, Department of Experimental Pharmacology at the same University, and at Hospital Cochin, Paris, France, before joining the Developmental Endocrinology Branch of the then National Institute of Child Health & Human Development, first as a student, and then as a postdoctoral fellow in 1988. In 1990, he continued his post-graduate medical education at Georgetown University Medical School, Washington, D.C., where he finished a residency in pediatrics and two fellowships in pediatric endocrinology (as part of the NICHD/Georgetown training program) and in medical genetics and clinical dysmorphology.



Several SOT Members Recipients of the NIEHS Outstanding New Environmental Sciences (ONES) Program
Submitted on Sep 15, 2011

This July, several SOT members were honored at the National Institute of Environmental Health Sciences (NIEHS) Outstanding New Environmental Scientist Awards (ONES) program, when all 35 ONES researchers were invited to gather and share their science with each other and with NIEHS scientists. The idea for this, according to NIEHS Training and Career Programs Health Science Administrator Carol Shreffler was, “Since this was the year that the first class was in the fifth year of their award and they’re transitioning off to other sources of funding, we wanted to have a combined meeting, so the younger people could learn from the older people and so we could get an idea of what the spectrum of the program looked like.”

The ONES program was initiated in 2006 and was designed to attract young investigators into the field to support their transition to independence and to encourage a long-term commitment to environmental health science research. The program offered substantial funding, protected time and an advisory committee of senior expert in the field of scientific and career path advice.

The following SOT members participated and are recipients of the ONES Awards Program:

  • James Luyendyk, University of Kansas
  • Jared Brown, East Carolina University
  • Donna Zhang, University of Arizona
  • Jingbo Pi, Hamner Institutes for Health Sciences
  • Dana Dolinoy, University of Michigan
  • Thomas Begley, University of Albany
  • Scott McCulloch, North Carolina State University
  • Yu-ying He, University of Chicago
  • Timothy Nurkiewicz, University of West Virginia


US EPA Sets Dioxin Assessment Schedule
Submitted on Sep 01, 2011

The US Environmental Protection Agency (US EPA) plans to complete the non-cancer portion of EPA’s Reanalysis of Key Issues Related to Dioxin Toxicity and Response to NAS Comments, and post the final non-cancer assessment to the Integrated Risk Information System by the end of January 2012. After completing the non-cancer portion, US EPA will finalize the cancer portion of the dioxin reanalysis as quickly as possible. The decision to split the dioxin assessment into two portions, one being the cancer assessment and the other being the non-cancer assessment, follows the release by the Science Advisory Board of its final review report of EPA’s Reanalysis of Key Issues Related to Dioxin Toxicity and Response to NAS Comments on August 26, 2011. This reanalysis report responded to the recommendations and comments included in the National Academy of Sciences’ (NAS) 2006 review of US EPA’s 2003 draft dioxin assessment.



US FDA Launches Strategic Plan for Regulatory Science
Submitted on Sep 01, 2011

The US Food and Drug Administration (US FDA) has launched a new strategic plan for regulatory science called, Advancing Regulatory Science at US FDA.

The new strategy targets eight cross-cutting priority areas including the following:

  • Toxicology—modernize toxicology to enhance product safety
  • Product development/Personalized Medicine—stimulate innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes
  • Product Manufacturing—support new approaches to improve product manufacturing and quality
  • Emerging Technologies—ensure US FDA readiness so the agency can evaluate innovative emerging technologies
  • Information Sciences—launch diverse data through information sciences to improve health outcomes
  • Food Safety—initiate new prevention-focused food safety system to protect public health
  • Global Health Security—develop medical countermeasures to protect against threats to U.S. and global health and security
  • Informed Decisions by Consumers—bolster social and behavioral science to help consumers and professionals make informed decisions about regulated products

The plan was developed by US FDA’s Centers and the Office of the Chief Scientist and is driven by US FDA’s mission. The vision of the new strategy is to, “advance regulatory science to speed innovation, improve regulatory decision-making, and get products to people in need. 21st Century regulatory science will be a driving force as US FDA works with diverse partners to protect and promote the health of our nation and the global community.”

For more information about the new strategy see the US FDA website.



Public/Private Partnership Accepting Grant Applications Aimed at Anesthetics/Sedatives and Their Potential to be Neurotoxic
Submitted on Aug 25, 2011

The U.S. Food and Drug Administration have teamed up with the International Anesthesia Research Society for the purpose of learning whether anesthetics/sedatives are neurotoxic and/or impede the normal development of the human brain. The project, called SmartTots, is accepting applications that are designed to address the following questions:
  1. Do short and/or long anesthetic exposures in human neonates and young children result in neuronal or glial cell death, structural abnormalities or the brain, or functional abnormalities of the brain?
  2. Do short and/or long anesthetic exposures in human neonates and young children result in persistent behavioral abnormalities (intellectual, motor, social, emotion, etc)?
  3. Are specific anesthetics and sedatives or specific frequency, duration or timing of anesthetic exposure correlated with detrimental effects on brain structure or function in humans?

Interested applicants must hold an M.D. or Ph.D. degree and each investigator must submit a biosketch. All current and extra-mural funding of all applicants must be disclosed in the Other Support document. Project titles and any overlap to the proposed project must be listed. Applications must be submitted no later than 11:59 PM, October 21, 2011. Visit the Web site for information about RFA guidelines or the application process.



Comments Sought on Risk-based Quality Management in Clinical Trials


European Medicines Agency Seeks Public Input on Guideline on Non-Clinical Local Tolerance Testing of Medicinal Products
Submitted on Aug 16, 2011

The European Medicines Agency is seeking public input on a recently published draft concept paper on the need to revise the Guideline on non-clinical local tolerance testing of medicinal products.

The focus on local tolerance testing has broadened over the last few years, with newer methods of drug delivery being developed. In vitro methods are becoming an integral part of the non-clinical testing local tolerance testing program of human medicinal products and approaches aiming at reducing or refining animal studies are routinely implemented in regulatory guidelines, where applicable.

According to the European Medicines Agency, a revision of the Guideline on Non-Clinical Local Tolerance Testing of Medicinal Products is warranted and the revised Guideline will also aim to harmonize local tolerance testing requirements with those outlined in the ICH Guideline M3(R2) - Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.

View the document available for consultation.

Comments related to this concept paper should be provided using this template.

The deadline for comments for this concept paper is October 30, 2011. The completed comments form should be e-mailed to the European Medicines Agency.



NIH Seeks Public Input on NIH Common Fund Programs
Submitted on Aug 16, 2011

The National Institutes of Health (NIH) is seeking public comment on NIH Common Fund Programs. The Common Fund supports exceptionally innovative programs that are inherently high-risk but have the potential for high-payoff by catalyzing research across all of NIH and in the biomedical research community.NIH is looking for ideas that have the potential to fundamentally change how scientists “think about, support or do research in a specific field or to create a new field altogether.” More information about the Common Fund is available on the NIH Common Fund Web site.

Comments are due on September 14, 2011. To provide input, visit the NIH Strategic Planning Web site.



US EPA Awards Contracts to Four U.S. Companies to Test 10,000 Chemicals
Submitted on Aug 16, 2011

The US Environmental Protection Agency (US EPA) has awarded four contracts to companies to test up to 10,000 chemicals for potential toxicity to people and the environment. The four companies include Vala Sciences, Cee Tox, CellzDirect and BioReliance. These companies will initially screen up to 1,000 chemicals currently in the ToxCast program using such technologies as stem cell toxicity tests.


US EPA Seeks Public Input on Policy That Ensures Scientific Integrity
Submitted on Aug 15, 2011

The US Environmental Protection Agency (US EPA) is seeking public comment on its draft Integrity Policy, which was devised in response to a December 10 White House Memorandum mandating that federal agencies develop policies in four areas including:

  • Foundations of scientific integrity in government
  • Public communications
  • Use of federal advisory committees
  • Professional development of government scientists and engineers

The draft policy seeks input on the promotion of scientific ethical standards including quality standards, communications with the public, the use of advisory committees, and peer review and professional development. Comments on the policy are due by September 6. To see a draft of the policy, please visit the US EPA website.



US EPA Rule on Reporting of Chemical Information Finalized
Submitted on Aug 15, 2011

The US Environmental Protection Agency (US EPA) has issued a final rule that will require chemical manufacturers to increase the type and amount of information US EPA collects on commercial chemicals. The rule, known as the chemical data reporting rule (CDR), mandates that companies submit the information electronically and limits confidentiality claims by companies. The rule also requires more frequent reporting of critical information on chemicals and requires the submission of new and updated information relative to potential chemical exposures, current production volume, manufacturing site-related data, and processing and use-related data for a larger number of chemicals. The CDR rule is part of the Toxic Substances Control Act inventory update rule (IUR). These new reporting requirements become effective during the next submission period which runs from February 1, 2012 to June 30, 2012. More information about the CDR Rule is available on the US EPA website.


HHS to Propose Sweeping Changes Relative to Human Subjects Research
Submitted on Aug 02, 2011

The Department of Health and Human Services (HHS) announced recently that the agency will propose sweeping changes to the regulations that cover human subjects research. Known as the Common Rule, the regulations need to be brought up-to-date to ensure the safety and welfare of research participants.

The HHS issued a Notice of Proposed Rulemaking in the Federal Register on July 26 calling for public comment on the following issues:
  • Revise the existing framework to calibrate more accurately the level of review to the level of risk.
  • Mandate that a single institutional review board review all domestic site of multi-site studies.
  • Establish mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data.
  • Adopt a systematic approach for the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonize the wide variety of definitions and reporting requirements.
  • Extend federal regulatory protections to all research conducted at U.S. institutions.
  • Provide uniform guidance on all federal regulations.


Stem Cell Case Dismissed in Federal Court
Submitted on Aug 02, 2011

In late July, a Federal District Court Judge Royce Lamberth dismissed the claims that were made previously by two adult stem cell researchers. The judge also dismissed the suit the two researchers brought to bar federal funding of human embryonic stem cell research and ruled that the National Institutes of Health did not violate the Administrative Procedures Act in issuing the NIH Stem Cell Guidelines.


Tony Scarpa Announces His Resignation
Submitted on Jul 27, 2011

Antonia Scarpa, Director of the Center for Scientific Review, has announced his resignation, which will take effect in early September. Dr. Scarpa left Case Western Reserve University School of Medicine and joined the National Institutes of Health (NIH) in July 2005. While serving as the Director, Dr. Scarpa made several changes to the peer review system.


US EPA Seeks Public Input on BPA
Submitted on Jul 27, 2011

The US Environmental Protection Agency (US EPA) announced recently that it is seeking public comment on possible toxicity testing and environmental sampling to study BPA’s potential environment impacts. This announcement follows the Agency’s action last March to develop an Action Plan for BPA, which outlined possible steps U.S. EPA might take to address possible risks associated with BPA, including the testing that U.S. EPA just announced. Comments on the action plan are due by September 26, 2011. U.S. EPA is providing this ANPRM to request comments on requiring toxicity testing to determine the potential for BPA to cause adverse effects, including endocrine-related effects, in environmental organisms at low concentrations. U.S. EPA is also seeking comment on requiring environmental testing consisting of sampling and monitoring for BPA in surface water, ground water, drinking water, soil, sediment, sludge, and landfill leachate in the vicinity of suspected BPA releases to determine whether environmental organisms may currently be exposed to concentrations of BPA in the environment that are at or above levels of concern for adverse effects, including endocrine-related effects. This ANPRM is directed only toward the environmental presence and environmental effects of BPA. To read the request visit the Government Printing Office website.


AAALAC Adopts New Position Statements on the 8th Edition to the Guide
Submitted on Jul 27, 2011

The AAALAC International’s Council on Accreditation has adopted new Position Statements to address several points in the 8th edition of the Guide for the Care and Use of Laboratory Animals (NRC 2011) that required interpretation for institutions participating in AAALAC’s accreditation program. The points address: Selecting the Appropriate Standard(s) for the Care and Use of Agricultural Animals; Cage or Pen Space; Social Housing; The Attending Veterinarian and Veterinary Care (this updates and replaces the existing Position Statement on Adequate Veterinary Care); Safety Requirements for Walk-In Cage/Rack Washers and Bulk Sterilizers; and Definition of “Laboratory Animals” (this updates and replaces the existing Position Statement on this subject). To view the new statements see the AAALAC website.


SOT’s 50th Anniversary Annual Meeting and ToxExpo is one for the History Books!
Submitted on Jul 27, 2011

The SOT 50th Annual Meeting and ToxExpo set multiple records for attendance, sessions and activities. Certainly, a good deal of thanks goes to the Scientific Program Committee, who planned the scientific program and 50th Anniversary Task Force, who arranged many special festivities. But, a great deal of thanks needs to go to the members of the Society who came to Washington, DC to attend our 50th Anniversary Annual Meeting. Without every attendee, this special event wouldn’t have been the success it was. Thank you for coming and making our 50th Anniversary Annual Meeting a smashing success!

We have some special anniversary items from our 50th that we would like to share with you. We have our 50th Anniversary publication, “The Society of Toxicology: The First Fifty Years,” which we will be happy to ship to you free-of-charge. The SOT is also making photos available to attendees at no cost. Simply visit the Annual Meeting Convention Photo page and download any low resolution image you would to have. High resolution photos can also be ordered from SOT official photographer, Convention Photography by Jeff Orlando.

We also have copies of the 50th Anniversary publication, “Building for the Future: Toxicology Training Centers,” which highlights the history and people behind more than 50 universities and colleges that have developed toxicology training programs. Another publication, “Historical Perspectives” offers some interesting stories about some of the topics and toxicologists who helped move the science forward.

We also have a limited number of benchmarks posters available, which we would be happy to mail to you free-of-charge.

We are grateful for your support for your Society and the science of toxicology!



Public Input Requested on OMB Circular A-21
Submitted on Jul 15, 2011

The Office of Management and Budget (OMB) is seeking public input on Circular A-21 and is requesting that comments be submitted by July 28, 2011.

The Circular A-21 is a document that established key principles for determining costs applicable to grants, contracts, and other agreements between the federal government and educational institutions. According to OMB, the principles were designed to “ensure the federal government covered its fair share of these institutions’ total costs.” The requirements set for in the document also created administrative burdens that the Obama Administration believes could likely be reduced without undermining the effectiveness of the Circular. OMB is specifically looking for comments on the following:

  1. Identify the issues(s) and impact(s) on institutions, researchers, or both; and
  2. Where possible, quantify the impacts, e.g., in terms of cost to the institution or the estimated number of hours (or percentage of time) that researchers or compliance staff spend addressing the issue(s).

For more information about the submission process, see the NIH website.



US EPA Proposes Companies Report New Uses of Glymes in Consumer Products
Submitted on Jul 15, 2011

The US Environmental Protection Agency is proposing to strengthen public health by requiring companies to report new uses of chemicals known as glymes in consumer products. According to Steve Owens, assistant administrator for US EPA’s Office of Chemical Safety and Pollution Prevention, “this proposed rule would enable US EPA to evaluate the use of these chemicals before Americans are subject to additional exposure to them in numerous consumer products. ”

The proposed regulatory procedure is known as a significant new use rule (SNUR) under the Toxic Substances Control Act. Comments on the proposal must be received on or before September 9, 2011.The proposal and other information about the SNUR can be found at the government Regulations website.



US FDA To Hold Workshop on Scientific Evaluation of Modified Risk Tobacco Product Applications
Submitted on Jul 15, 2011

The US Food and Drug Administration (US FDA) announced recently that the agency will hold a public workshop to create a forum for appropriate scientific and medical experts and other interested stakeholders to provide input on the design and conduct of studies and surveillance required for assessment and ongoing review of modified risk tobacco product applications. US FDA is also opening the public docket to receive comments on this matter as well. Written comments can be submitted to US FDA by September 23, 2011, electronically at the government Regulations website.

More information about the workshop and requirements is available by going to the Government Printing Office website.



US FDA Makes Guidance Available on Classification of Products as Drugs and Devices
Submitted on Jul 15, 2011

The US Food and Drug Administration is making two sets of guidance available for industry and US FDA staff to comment on concerning the classification of products as drugs and devices. The guidance is titled, “Draft Guidance for Industry and US FDA Staff: Classification of Products as Drugs and Devices and Additional Classification Issues” and “Draft Guidance for Industry and US FDA Staff: Interpretation of the Term ‘Chemical Action’ in the Definition of Device Under Section 201(h) of the Federal Food, Drug and Cosmetic Act.” Comments on the draft guidance must be submitted by September 19, 2011, to the Regulations website.

For more information about these draft documents, see the Government Printing Office’s website.



US FDA Makes Guidance Available on “Whether an FDA-Regulated Product Involves the Application of Nanotechnology”
Submitted on Jul 15, 2011

The US Food and Drug Administration (US FDA) is announcing the availability of a draft guidance for industry entitled “Considering Whether an US FDA-Regulated Product Involves the Application of Nanotechnology.” This guidance is intended to provide industry with US FDA’s current thinking on whether US FDA-regulated products contain nanomaterials or otherwise involve the application of nanotechnology.

The points to consider are intended to be broadly applicable to all US FDA-regulated products, with the understanding that additional guidance may be articulated for specific product areas, as appropriate in the future. Comments must be submitted by August 15, 2011, to the Regulations website.



CDC Solicits Comments on Research, Policy, and Practice Environment in Public Health Genomics
Submitted on Jul 15, 2011

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is announcing the opening of a docket to solicit comments, data, and other information helpful to assess the current research, policy, and practice environment in public health genomics. HHS/CDC is currently leading a process to assess the most important steps for public health genomics in the next five years. Comments must be submitted by August 1. Comments may be submitted to:

Office of Public Health Genomics, Centers for Disease Control and Prevention
1600 Clifton Road, NE., MS-E61
Atlanta, Georgia 30333
Attn: Docket No. CDC-2011-0008.


NIEHS to Explore Potential Harmful Effects of Gulf Oil Spill on Reproduction and Birth Outcomes
Submitted on Jul 15, 2011

The National Institutes of Health (NIH) announced recently that funded network of research institutes will begin a research project to study the potential harmful effects of the Deepwater Horizon (Gulf Oil Spill) disaster on reproduction and birth outcomes. The project, with funding totaling $25.2 million for a five-year period, will provide funding to four institutions including the Louisiana State University Health Sciences Center New Orleans, the Tulane University, University of Florida and the University of Texas Medical Branch at Galveston to conduct the following studies:

Institute Research Title
Louisiana State University Health Sciences Center New Orleans Women and Their Children’s Gulf Consortium
Tulane University Trans-disciplinary Research Consortium for Gulf Resilience on Women’s Health
University of Florida Health Impact of Deepwater Horizon Spill in Eastern Gulf Coast Communities
The University of Texas Medical Branch at Galveston Gulf Coast Health Alliance: Health Risks Related to the Macondo Spill

Cornelis Elferink, an SOT member and a professor of the University of Texas Medical Branch at Galverston, is the principal investigator for the Gulf Coast Health Alliance: Health Risks to the Macondo Spill study.

According to Linda Birnbaum, SOT Member and Director of the National Institutes of Environmental Health Sciences (NIEHS), “Our number one goal is to provide strong science that will help people now and during future disasters.” NIEHS and other NIH components are contributing support to this project including: the National Cancer Institute, the National Center for Research Resources, National Heart, Lung and Blood Institute, National Institute of Nursing Research, and the Office of Behavioral and Social Sciences Research.



Legislation Introduced to Eliminate Class-B Dealers from Providing Dogs and Cats to Research Institutes
Submitted on Jul 15, 2011

Rep. Michael Doyle (D-PA) has introduction legislation, H.R. 2256, the Pet Safety and Protection Act of 2011, which would in effect eliminate US Department of Agriculture-licensed Class B dealers as providers of random source dogs and cats to research facilities. The legislation has 23 co-sponsors and has been referred to the House Committee on Agriculture.


Safe Cosmetics Bill Introduced in the House
Submitted on Jul 15, 2011

Rep. Jan Schakowsky (D-IL) has introduced the Safe Cosmetics Act of 2011 (H.R. 2359) in the House of Representatives. The legislation would give the U.S. Food and Drug Administration more authority over personal care products and their ingredients. The bill would also alter how cosmetics are regulated and make their more in line with other U.S. FDA-regulated products. The bill has been referred to the House Committee on Energy and Commerce, and the House Committee on Education and the Workforce.


U.S. EPA Set to Strengthen the Integrated Risk Information System (IRIS) and SOT Commits to Assisting U.S. EPA in This Effort
Submitted on Jul 12, 2011

The U.S. Environmental Protection Agency (U.S. EPA) has announced plans to strengthen the Integrated Risk Information System (IRIS). In a release issued today, Dr. Paul Anastas said, “decision makers rely on the IRIS Program for accessible, science-based health assessments of environmental contaminants. Further strengthening of the IRIS program is part of U.S. EPA’s commitment to continuous improvement and ensuring we use the best possible science to protect human health and the environment.”

The improvements that U.S. EPA announced today include the following:

  • U.S. EPA will create a new peer consultation step early in the development of major IRIS assessments to enhance the input of the scientific community.
  • IRIS assessment documents will be shorter, clearer and more visual, concise and transparent.
  • Documents will be edited to eliminate inconsistencies and address redundancies and will include more graphical and tabular representations of the data.
  • U.S. EPA will evaluate and describe the strengths and weaknesses of critical studies in a more uniform way.

The IRIS system is a human assessment program that evaluates quantitative and qualitative risk information on effects that may result from exposure to environmental contaminants. The program was created by U.S. EPA in 1985 to develop consensus opinions about the health effects that may result from chronic exposure to various substances in the environment. The database contains information that can be used to support hazard identification and dose-response evaluation, the first two steps of the risk assessment process. The cornerstone of the program is a collection of searchable documents that describe the health effects of individual substances and that contain descriptive and quantitative information for both cancer and non-cancer endpoints.

There are more than 540 chemicals currently in the IRIS database that include critical information about how these chemicals impact human health.

In response to this announcement, SOT leadership has conveyed its commitment to help U.S. EPA achieve its goal of providing an even stronger IRIS program. SOT currently has a government liaison group that is engaged with U.S. EPA representatives to enhance U.S. EPA’s mission of protecting public health and the environment.



NIH Releases Costs Connected with Maintaining Research Chimpanzees
Submitted on Jun 23, 2011

The National Institutes of Health (NIH) Office of Extramural Research recently released a document that details the costs associated with maintaining National Center for Research Resources (NCRR) supported research chimpanzees. According to the NCRR, it costs $34 per day per chimpanzee to maintain research populations at the two research centers and it costs $69 per day to maintain the mammals at the sanctuary that NIH built in 2002–2004 to house the 130 federally-owned retired chimpanzees over their lifetime. For more information about this, see the NIH Web site.


NIH Creates Community Resource of Genome-wide Epigenetic Maps
Submitted on Jun 23, 2011

Researchers in the Reference Epigenome Mapping Consortium, part of the NIH Common Fund’s Roadmap Epigenomics Program, have begun creating a community resource of genome-wide epigenetic maps in a variety of human primary cell and tissue types. The data currently represent more than 100 samples including adult and fetal cells and tissues, and embryonic and induced pluripotent stem cells. The majority of reference epigenomes being generated contain information about DNA methylation, a core set of histone modifications, chromatin accessibility, and gene expression. A subset of reference epigenomes will also contain an expanded set of at least twenty additional histone modifications. The Consortium’s Web site provides information about protocols developed by Consortium members, information about data standards, and links to a variety of sites where the epigenomic data can be visualized in a genome browser or downloaded for subsequent analysis.


U.S. EPA Proposes Policy on Nanoscale Materials in Pesticide Products
Submitted on Jun 17, 2011

The U.S. Environmental Protection Agency (U.S. EPA) announced recently that U.S. EPA will obtain information on nanoscale materials in pesticide products to help the agency determine whether the registration of a pesticide may cause unreasonable adverse effects on the environment and human health. U.S. EPA plans to publish policy options in the Federal Register shortly. More information about the proposed notice is available at the U.S. EPA Web site.


HHS Secretary Letter to Sen. Harkin Details Budget for New NIH Translational Center
Submitted on Jun 17, 2011

Health and Human Services Secretary Kathleen Sebelius provided details to Sen. Tom Harkin (D-IN) Chairman of the Senate Committee on Health, Education, Labor and Pensions, on the proposed budget realignment for the new National Center for Advancing Translational Sciences at the National Institutes of Health (NIH). She reported that most of the funds for the new Center would come from abolishing the National Center for Research Resources (NCRR) and from redistributing funds formerly in NCRR throughout the Institutes. For 2012, NCRR was slated to receive a total of $1.3 billion. Now, a total of $553 million would move to the new center. A majority of those funds ($480 million) would be used for the Clinical and Translation Science Award program. In addition, $347 million of the original budget for NCRR would be transferred to the National Institute of General Medical Sciences (NGMS) and $303 million would go the Office of the Director of NGMS. The Secretary reported that Comparative Medicine, which includes the National Primate Research Centers, would move to the Office of the director and the Institutional Development Awards and the Biotechnology Research Resources Program would move to the NGMS.


U.S. EPA Releases Two Databases to Enhance Information on Chemicals
Submitted on Jun 17, 2011

The U.S. Environmental Protection Agency (U.S. EPA) is releasing two databases to make it easier for the public to find data about chemicals. The first database, called the Toxicity Forecaster database (ToxCastBD), will allow users to search and download data from more than 500 rapid chemical tests conducted on more than 300 environmental chemicals. The database uses advanced scientific tools to predict the potential toxicity of chemicals and to provide a cost-effective approach for prioritizing chemicals that need additional testing. ToxCast is currently screening 700 additional chemicals and that data will be available in 2012. The second database, ExpoCast DB, consolidates human exposure data from studies that have collected chemical measurements from homes and child care centers. Data include the amounts of chemicals found in food, drinking water, air, dust, indoor surfaces, and urine.

Both databases are connected to U.S. EPA’s Aggregated Computational Toxicology Resource, which is an online data warehouse that collects data on more than 500,000 chemicals from more than 500 public sources.



U.S. FDA Makes Guidance Available on Products and Nanomaterials
Submitted on Jun 17, 2011

The U.S. Food and Drug Administration (U.S. FDA) announced in the June 14 Federal Register the availability of new guidance, “Considering Whether an U.S. FDA-Regulated Product Involves the Application of Nanotechnology.” The guidance will be used for industry to detail FDA’s current thinking on whether U.S. FDA-regulated products contain nanomaterials or otherwise involve the application of nanotechnology. Persons can submit comments to the U.S. FDA on the guidance no later than August 15, 2011.  You can obtain a copy of the guidance on-line at the U.S. FDA Web site.


NSF to Host Workshop, “Science: Becoming the Messenger”
Submitted on Jun 09, 2011

The National Science Foundation (NSF) will be holding a workshop, “Science: Becoming the Messenger” on July 21, 2011, at Clayton Hall on the University of Delaware campus located in Newark, Delaware. Principal investigators (PI), early career researchers and engineers, graduate students and postdocs from institutions and universities in Delaware who would like to learn to communicate effectively to a broad audience are encouraged to attend. For more information see the NSF Web site.


NIH Creates Community Resource of Genome-wide Epigenetic Maps
Submitted on Jun 09, 2011

Program, have begun creating a community resource of genome-wide epigenetic maps in a variety of human primary cell and tissue types. The data currently represent more than 100 samples including adult and fetal cells and tissues, and embryonic and induced pluripotent stem cells. The majority of reference epigenomes being generated contain information about DNA methylation, a core set of histone modifications, chromatin accessibility, and gene expression. A subset of reference epigenomes will also contain an expanded set of at least twenty additional histone modifications. The Consortium’s website provides information about protocols developed by Consortium members, information about data standards, and links to a variety of sites where the epigenomic data can be visualized in a genome browser or downloaded for subsequent analysis.


U.S. EPA Removes Confidentiality Claims on Chemicals
Submitted on Jun 09, 2011

The U.S. Environmental Protection Agency (U.S. EPA) has made public the identities of more than 150 chemicals that are included in 104 health and safety studies.  The chemicals will no longer be redacted or kept from view.  This move, according to officials at the U.S. EPA, is designed to provide the public with more access to information on the chemicals that are manufactured and used in the United States.

Over the past several months, the U.S. EPA has taken other steps to make chemical information more accessible to the public by providing free access to the consolidated TSCA Inventory on the U.S. EPA and Data.Gov Web sites and by launching a new chemical data access tool that gives the public the ability to electronically search U.S. EPA’s database of more than 10,000 health and safety documents on a wide range of chemicals.

For more information about the public’s access to chemical information, see the U.S. EPA Web site.



U.S. Appeals Court Lifts Stem Cell Funding Injunction
Submitted on May 10, 2011

In a split decision, the U.S. Court of Appeals on May 6 lifted a temporary injunction that prohibited the National Institutes of Health (NIH) from funding human embryonic stem cell (hESC) research. The ruling relates to the preliminary injunction and not on the underlying merits of the case. The plaintiffs who originally argued for the injunction have made other claims in an effort to block federal funding. These claims have not been addressed by the District Court or the Appeals Court.


Poison Control Center News and Updates
Submitted on May 06, 2011

Poison Control Centers’ Funding Cut But Not Eliminated—FY 2011 funding for U.S. poison control centers around the country was cut 25%, but much less than the cut proposed by a House bill, H.R. 1. To learn more about the budget cuts, please see the Poison Control Press Release.

Poison Control Centers Handle more than 4.2 Million Calls During 2009 U.S.—Poison Control Center around the U.S. handled more than 4.2 million calls in 2009, with household cleaning substances, analgesics, cosmetics, and personal care products topping the list of emergency calls. To learn more, please see the Poison Control Press Release.

Poison Control Centers Working with Centers for Disease Control and Prevention to Monitor Radiation Exposure Questions—U.S. Poison Control Centers everywhere in the U.S. have agreed to work with the U.S. Centers for Disease Control and Prevention and state health departments to respond to public concerns about radiation exposures from nuclear power plans that may have resulted following the earthquake in Japan. To learn more about what they will be doing, please see the Poison Control Press Release.



Lautenberg Introductions TSCA Reform Legislation
Submitted on Apr 22, 2011

Sen. Frank Lautenberg (D-NJ) introduced the Safe Chemicals Act of 2011, S., on April 14, along with three co-sponsors, including Sen. Amy Klobuchar (D-MN), the SOT 2011 Congressional Science Leadership Award recipient, Sen. Charles Schumer (D-NY) and Barbara Box (D-CA). Like the bill he introduced last Congress, the legislation requires that chemical companies demonstrate the safety of industrial chemicals and the U.S. Environmental Protection Agency (U.S. EPA) then evaluate the safety of the chemical based on the best science. The bill also establishes risk-based prioritization categories and gives U.S. EPA authority to focus its resources on those chemicals that are considered the highest risk. Under this bill, chemical companies would be required to submit basic hazard and exposure data and to assess the need for further testing or restrictions. The bill also gives U.S. EPA authority to extend all requirements under the Act to mixtures if the U.S. EPA Administrator determines that “such extension is reasonable and efficient.” A more detailed analysis of the legislation will be provided shortly.


Congress Passes Budget Legislation for FY 2011
Submitted on Apr 22, 2011

On April 15, 2011, the Senate and House passed final continuing resolution bills to fund the federal government for the remainder of FY 2011 and President Obama signed the legislation into law. The final continuing resolution includes $38.5 billion in spending cuts from the FY 2010 levels. The legislation includes $30.7 billion for the National Institutes of Health, which is a $320 million reduction from 2010. The bill stipulates that $210 million be cut from all institute, center and the Office of the Director budgets and $50 million from the intramural buildings and facilities account. The bill also does not include statutory mandates governing NIH grant numbers and size. The original bill (H.R. 1) had mandated that the director of NIH shall ensure that the average of the total cost of Competing Research project Grants for all of the Institutes, Centers, Office of the Director during fiscal year 2011 shall not exceed $400,000. Funding totaling $6.261 billion is also cut from the Health Resources and Services Administration and the administrator of the Administration is directed to develop a FY 2011 spending plan within 30 days of enactment to determine which programs within the agency will absorb much of the $1.2 billion reduction. The legislation also cut National Science Foundation funds to $6.806 billion, which represents a $65.75 million decrease from FY 2010 levels. The Centers for Disease Control and Prevention funding was cut by 11.7 percent to $5.649 billion. U.S. EPA’s budget was cut by $1.6 billion reduction, a 16 percent cut from last year’s level. The U.S. Food and Drug Administration received one of the few increases in funding. The total for the remainder of FY 2011 was set at $2.447 billion. Funding for the U.S. poison control centers was cut by nearly 25 percent. The original bill (H.R. 1) called for a 93 percent reduction in federal funding, which accounts for approximately 20 percent of total funding for poison centers.


Great Ape Legislation Introduced in House and Senate
Submitted on Apr 22, 2011

Identical legislation has been introduced in the House and Senate that would prohibit the use of chimpanzees for biomedical research. The House version, H.R. 1513, has 42 co-sponsors and was referred to the House Energy and Commerce Committee for consideration. The Senate version, S. 810, has three co-sponsors and was referred to the Senate Environment and Public Works Committee.


Call to SOT Members—Continuing Resolution
Submitted on Apr 07, 2011

SOT members are asked to contact their Members of Congress to urge them to continue to seek compromises in the budget negotiations. Additionally, your Members need to know that sustained investment in research is imperative to ensure the health of Americans and the nation’s economic well being. There are some who say that we cannot afford to invest in science and that research is not essential in these difficult times. But, we hold that science is essential for our prosperity, our security, our health, our environment, and our quality of life.

To contact your Member, go to the Contacting Congress Web site and follow the instructions.



SOT Member Call to Action
Submitted on Apr 07, 2011

SOT’s leadership is urging SOT members to contact Rep. Harold Rogers (R-KT), Chairman of the House Appropriations Committee and Rep. Denny Rehberg (R-MT), Chairman of the House Subcommittee on Labor, Health and Human Services and Education Appropriations Committee, and urge them to reject efforts to substantially reduce or eliminate funding for the U.S. network of poison control centers. As chairman of this subcommittee, Rep. Rehberg is the one who will be asked by the full House Appropriations Committee to make recommendations on specific programs to cut and he currently has poison control centers on his list of cuts.

In Fiscal Year 2010, Congress allocated $29.3 million in funding to supplement local and state support for the 57 poison control centers that serve our nation 24 hours per day, year-round. Federal dollars represent approximately 20 percent of the total required to operate the entire U.S. poison center network; the remainder is provided by state and local partners, as well as the universities, hospitals, and other facilities that house poison centers. The program is an outstanding example of a successful public-private/state-federal partnership clearly benefiting public health nationwide. Poison control services save healthcare dollars and save lives. The extraordinary value of the national poison center program was documented in a 2004 Institute of Medicine report, which noted that poison centers save over $7 for every $1 spent in state and federal funding.

Tell Reps. Rogers and Rehberg that this modest investment prevents more than $1 billion of unnecessary healthcare costs annually. The savings chiefly reflects safe home management of patients with possible poisoning, toxic exposures and adverse drug reactions who would otherwise unnecessarily utilize doctors’ offices, ambulances, and hospitals at a much greater cost. An additional $9 is saved for every $1 spent in improved care of poisoned patients admitted to hospitals for care. Failing to provide federal financial support will close poison centers, decrease access to care, increase healthcare costs, and put lives at risk.

We are asking Congress to support level funding of $29.3 million for the national poison control program in the final FY2011 appropriations legislation and urge you to contact Rep. Rogers and Rep. Rehberg respectively. You can contact Rep. Rogers at 202.225.4601 or electronically via his contact form. Simply complete the form and send him an urgent message. To contact Rep. Rehberg, call 202.225.3211 or use his on-line contact form.



New Publication Available on Toxicology Training Centers
Submitted on Apr 07, 2011

SOT has just posted a new publication that highlights the history of several toxicology training centers. Entitled “Building for the Future: Toxicology Training Centers” the publication includes a number of articles about the scientists and programs that have made toxicology what it is today. To see this new edition, please visit the 50th Anniversary Web site.


NICHD Seeks Public Comment on Institute’s Vision
Submitted on Mar 31, 2011

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is seeking public comment on a series of white papers that will serve as a first step in the institute’s process for developing a scientific vision. The institute is interested in identifying the most promising scientific opportunities of the next decade and wants to set an ambitious agenda that achieves critical scientific goals and meets pressing public health needs. According to the Director of the Institute, Dr. E. Guttmacher, “We welcome the comments and suggestions of people from all walks of life—not just from the research community, but from public health and community leaders, educators, practicing clinicians and members of the general public. The insights and creativity provided by multiple perspectives will no doubt help to advance the Institute’s vitally important mission.” The NICHD sponsors research on development, before and after birth; maternal, child and family health; reproductive biology and population issues; and medical rehabilitation. The following gives links to the papers. Comments are due to NICHD by June 10, 2011.



Benchmark Posters Available!
Submitted on Mar 31, 2011

SOT has obtained additional copies of the Benchmark posters, so If you would like one, please e-mail Martha Lindauer to request one. The posters are free and there is no shipping fee.



NIEHS Launches Project to Update Strategic Plan
Submitted on Mar 31, 2011

The National Institute of Environmental Health Sciences (NIEHS) is launching a new project to update their 2006–2011 Strategic Plan. As a first step, the NIEHS has launched a Visionary Ideas Web site.

Everyone who visits the Web site can offer visionary ideas for updating the strategic plan. Then, NIEHS will hold a three-day Stakeholder Community Workshop July 12–14 in Research Triangle Park. NIEHS staff will select 200 participants to participate in the workshop and individuals are encouraged to nominate themselves or other colleagues by choosing “nominate workshop participant” on the NIEHS Web site.

The Strategic Plan established in 2006 includes seven overarching goals including the following:

  • Expand the role of clinical research in environmental health sciences
  • Use environmental toxicants to understand basic mechanism in human biology
  • Build integrated environmental health research programs to address the cross-cutting problems in human biology and human disease
  • Improve and expand community-linked research
  • Develop sensitive markers of environmental exposure, early biological response and genetic susceptibility
  • Recruit and train the next generation of environmental health scientists
  • Foster the development of partnerships between the NIEHS and other NIH institutes, national and international research agencies, academia, industry, and community organizations to improve human health

The plan also describes three critical challenges that face environmental health sciences that include:

  • Programmatic Scope: What diseases will be the focus of the NIEHS portfolio?
  • Integrative Science: Given the explosion in new science that has occurred in the last decade, how will we focus our research efforts on the most appropriate science for a given disease and the related environmental exposures?
  • Public Health Impact: How will we develop the scientific knowledge that empowers people to improve their environmental choices, allows society to make appropriate public health decisions, and results in us living healthier lives?


Benchmark Winners!
Submitted on Mar 03, 2011

On behalf of the leadership of the Society of Toxicology thank you to everyone who submitted a benchmark. The response to the program was overwhelming and while we promised we would select the winners, in the end, everyone is a winner. Congratulations to all who submitted benchmarks. Your name appears on the banner and on the posters. Thank you for the time you gave and the support you continue to give to SOT.

Benchmark Web site and Poster


In Memoriam
Submitted on Feb 21, 2011

Familly

Our good friend and long time colleague John (Jack) Davitt passed away last Friday, after a long battle with cancer.

Jack served at U.S. FDA for 27 years and as independent consultant for 20 years.


U.S. EPA and ECHA Sign Chemical Agreement
Submitted on Dec 27, 2010

To help promote enhanced technical cooperation on chemical management activities, the U.S. Environmental Protection Agency (U.S. EPA) and the European Chemicals Agency (ECHA) has signed a statement of intent that creates a partnership to improve chemical safety. One area of mutual collaboration is the area of data and information. Under the statement of intent, the two agencies will agree to exchange non-confidential information on hazards, uses and substance identification. The two agencies will also share criteria for managing confidential business information. The letter also enables the agencies to share information on approaches to more efficiently address chemicals of concern. For more information on the agreement, see the U.S. EPA Web site.


U.S. Senate Passes COMPETES Act
Submitted on Dec 27, 2010

During the final days of the 111th Congress, the Senate passed an amended version of H.R. 5116, a bill that renews programs authorized by the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Act, which was originally signed into law in 2007.

Sen. Jay Rockefeller IV, Chairman of the Senate Committee responsibility for devising the legislation, said in a statement following passage of the bill in the Senate, “This is an investment in America’s future and our long-term competitiveness in the global marketplace. This bill invests in R&D and in science, technology, engineering and mathematics (STEM) education—drivers of our economy and keys to our economic success. The investments we make now in science, technology, research and STEM education will pay incredible dividends down the road.”

The Final COMPETES bill is a compromise between the House and Senate versions that were approved by House and Senate Committees. The final version provides a three-year reauthorization for key federal science agencies including the National Science Foundation, the Department of Energy office of Science, and the National Institute of Standards and Technology. For additional information, please see SOT’s COMPETES article in the 2011 Winter Communique and visit the America COMPETES Web site.


Agency Sponsors National Conversation on Public Health and Chemical Exposures
Submitted on Dec 27, 2010

The Agency for Toxic Substances and Disease Registry (ATSDR) is hosting the National Conversation on Public Health and Chemical Exposures. The goal of the program is to develop an action agency with clear and achievable recommendations to help government agencies and other organizations strengthen their efforts to protect the public from harmful chemical exposures.

ATSDR in conjunction with the Centers for Disease Control and Prevention, the American Public Health Association, the Association of State and Territorial Health Offices, and RESOLVE are sponsoring a WebDialogue on January 5–6, 2011. To participate and give ATSDR your ideas about new ways to protect the public from harmful chemical exposures, go to the National Conversation Web site and register.


U.S. EPA Introduces New Tool to Access Chemical Information
Submitted on Dec 27, 2010

The U.S. Environmental Protection Agency (U.S. EPA) is making a new tool available to the public as part of U.S. EPA Administrator Lisa Jackson’s continued efforts to enhance U.S. EPA’s chemical management program and increase public transparency. The new tool is Web-based and allows the public to search for and have easy access to health and safety studies on industrial chemicals. For more information about this, see the U.S. EPA Web site.


Medicine Take-Back Events Kick Off in SeptemberMedicine Take-Back Events Kick Off in September
Submitted on Oct 08, 2010

The U.S. Drug Enforcement Agency and the U.S. Environmental Protection Agency are working together to launch drug take-back events in 1700 places around the country in late September. Citizens are asked to bring back unwanted solid prescriptions and over-the-counter medicines to anyone of the 1700 locations so that the medicines may be disposed of safely. Liquids like cough syrup will not be accepted. To find a location near you please visit the U.S. DEA Web site.


U.S. FDA Issues Final Rule on Safety Information and Clinical Trials
Submitted on Oct 08, 2010

The U.S. Food and Drug Administration (U.S. FDA) issued a final rule on September 6 that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics. The rule will expedite U.S. FDA’s review of critical safety information and enhance the ability of U.S. FDA to monitor the safety of investigational drugs and biologics. The rule requires that certain safety information that previously had not been required be reported within 15 days of an occurrence. More specifically these reports including:

  • Findings from clinical or epidemiological studies that suggest a significant risk to study participants;
  • Serious suspected adverse reactions that occur at a rate higher than expected;
  • Serious adverse events from bioavailability studies that determine whether a generic drug has the same bioavailability as the brand name drug.


Appeals Court Rules in Favor on Continued Stem Cell Research
Submitted on Oct 08, 2010

The D.C. Circuit Court of Appeals ruled September 9, 2010, that federal funding for stem cell research could continue stating that, “Appellants have satisfied the standards required for a stay pending appeal.” Judge Lamberth, who issued the August 23 injunction, still plans to move forward with his case and his ruling could come as soon as November.


U.S. EPA Proposes to Toughen Chemical Reporting
Submitted on Sep 21, 2010

The U.S. Environmental Protection Agency (U.S. EPA) is proposing to strengthen manufacturer chemical reporting requirements by mandating more reporting under the Inventory Update Reporting Rule of the Toxic Substances Control Act (TSCA). The proposed rule, issued in August, would require manufacturers, including importers, to submit chemical information electronically. The rule also increases the frequency of reporting and limits the information that can be treated as confidential so the public can access it. For more information, see the U.S. EPA Web site.


U.S. FDA Reopens Comment Period on Draft Guidance Document on CBRN Threats under the Animal Rule
Submitted on Sep 21, 2010

The U.S. Food and Drug Administration has reopened the comment period on a draft document, “Guidance for Industry: Animal Models—Essential Elements to Address Efficacy under the Animal Rule.” The guidance details important characteristics of an animal model that need to be addressed when developing products for approval under the Animal Rule. Public comments are due by January 5, 2011.


European Parliament Adopts EU Directive on Protection of Animals Use for Science
Submitted on Sep 21, 2010

The European Parliament has adopted the revision of the European Union (EU) Directive on the Protection of Animals Use for Scientific Purposes. The new directive will become law once the directive is published in the Official Journal of the European Union and once it is signed by the Council President.


Guttmacher to Become NICHD Director in August
Submitted on Jul 27, 2010

Francis Collins, director of the National Institutes of Health (NIH) has appointed Dr. Alan E. Guttmacher to be the new director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Dr. Guttmacher has been the Acting Director for the past eight months and is a pediatrician, geneticists, and highly regarded leader of the National Institutes of Health (NIH). Prior to coming to the NIH, the doctor directed the Department of Pediatrics’ Vermont Regional Genetics Center and Pregnancy Risk Information Service. He also served as the medical director of the Vermont Newborn Screening Program, founded Vermont’s only pediatric intensive care unit, and co-directed the Vermont Cancer Centers’ Familial Cancer Program. His appointment will take effect August 1, 2010. The NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation.


Portier Named Director, National Center for Environmental Health Agency for Toxic Substances and Disease Registry (NCEH/ATSDR)
Submitted on Jul 21, 2010

Dr. Christopher Portier has just been named Director, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (NCEH/ATSDR), effective August 1, 2010. Portier is an internationally recognized expert in the design, analysis and interpretation of environmental health data with a focus on carcinogenicity. His research efforts and interests include such diverse topics as cancer biology, risk assessment, bioinformatics, immunology, climate change, development, genetically modified foods, and genomics. He contributed to the development of cancer risk assessment guidelines for national and international agencies, and has either directed or contributed significantly to numerous risk assessments, most notably, dioxins, aflatoxins and electromagnetic fields.

He was previously employed as the Senior Advisor to the Director and Principal Investigator for Environmental Systems Biology at the National Institute of Environmental Health Sciences (NIEHS). He also served as Associate Director of NIEHS, Director of the Environmental Toxicology Program and Associate Director of the National Toxicology Program.


ARRIVE New Guidelines Call for Improvements in the Reporting of Animals Used in Research
Submitted on Jul 19, 2010

PLoS, recently published new guidelines that call for the improvement of the reporting of animal experiments. The so called ARRIVE (Animal Research: Reporting In Vivo Experiments) were developed by the NC3Rs to enhance the data from animal experiments and are geared for scientists writing up their research for publication in peer reviewed journals. Researchers, statisticians, journal editors and funders of animal research all collaborated to produce the guidelines, which have been published in five journals. The guidelines can be found by going to the NC3Rs Web site.


White House Offers Strategy and On-Line Workshops on Nanotechnology
Submitted on Jul 19, 2010

The White House Office of Science and Technology Policy and the National Science and Technology Council’s Subcommittee on Nanoscale Science, Engineering, and Technology is requesting public input on the proposed National Nanotechnology Initiative (NNI). The initiative is designed to achieve the following goals:
  • Advance a world-class nanotechnology research and development program.
  • Foster the transfer of new technologies into products for commercial and public benefit.
  • Develop and sustain educational resources, a skilled workforce, and the supporting Infrastructure and tools to advance nanotechnology.
  • Support responsible development of nanotechnology.
A series of on-line workshops are being planned and participants asked to submit comments to NNI Strategy Portal. The following provides the dates and themes for these workshops:
  • July 26–August 2: Coordination and Partnerships
  • August 2–9: Evaluation and Policy
  • August 9–15: Goals and Objectives
For more information about the strategic plan or the workshops visit the NNI Strategy Portal.


SOT 50th Anniversary Features Benchmarks in Toxicology Campaign
Submitted on Jul 08, 2010

2011 marks the 50th Annual Meeting of the Society of Toxicology and to recognize this historic event, SOT and the National Institute of Environmental Health Sciences (NIEHS) are sponsoring a special campaign, “Benchmarks in Toxicology.” Scientists from SOT and NIEHS are being asked to submit nominations of major events or people in toxicology that created formative benchmarks in the field of toxicology. To participate, log into ToXchange and access the Benchmarks Community.

Judges from SOT and NIEHS will select the final entries and those benchmarks will be displayed on an Annual Meeting poster and be posted on the SOT Web site. Judges will also randomly select one entry and provide that toxicologist with a free registration to the SOT 50th Annual Meeting and ToxExpo™. Submit as many benchmarks as you want. There are many benchmarks in toxicology and this campaign is a great way for toxicologists to begin to tell the public how toxicology is helping to create a safer and healthier world.


Institute of Medicine Host Public Workshop on “Assessing the Human Health Effects of the Gulf Oil Spill”
Submitted on Jul 08, 2010

At the request of the U.S. Department of Health and Human Services, the Institute of Medicine hosted a public workshop June 22–23, 2010 entitled, “Assessing the Human Health Effects of the Gulf of Mexico Oil Spill.” The workshop examined current knowledge about the effects on human health of exposure to oil, weathered oil products and dispersants. Gaps in knowledge were also highlighted and presenters explored methods and strategies for data gathering that will further our understanding of the risks to human health. Presenters also reviewed and assessed ways to monitor the spill’s potential negative effects on health. Several SOT members served as speakers for the workshop, which is available on-line at PROLibraries Web site.


U.S. EPA Office of Public Liaison Notice
Submitted on Jul 08, 2010

Dear Stakeholder/Interested Party:

“...While there is no perfect solution to the environmental disaster that the Gulf of Mexico is facing right now, U.S. EPA is committed to protecting our communities, the natural environment and human health. That commitment covers both the risks from the spill itself, as well as any concerns resulting from the response to the spill...”
U.S. EPA Administrator Lisa P. Jackson

A Conversation with U.S. EPA Administrator Lisa P. Jackson—Expanding the Environmental Conversation. A discussion between Administrator Lisa P. Jackson and the Editor in Chief of Essence Magazine, Angela Burt Murray about the 5th Anniversary of Hurricane Katrina and the impact of the Oil Spill.On Friday, July 2, at 1:00 PM to 1:45 PM CDT, at the Ernest N. Morial Convention Center, 900 Convention Center Blvd., New Orleans, LA 70130-1799. Free to the Public!


National Science Foundation Gears up Research Projects to Study Impact of the Gulf Oil Spill
Submitted on Jun 21, 2010

The National Science Foundation (NSF) is gearing up to fund the so called Rapid Response Research (RAPID) proposals that researchers from around the country have submitted to study the environmental effects of the oil spill. Proposals that have been submitted include biogeochemical studies of the spill’s impact on trace metal distribution in Gulf waters and on sandy beaches, biological studies tracking the effect on blue crab populations, and salt marshes. Under the RAPID grant initiative, researchers will receive up to $200,000 for a research project and approximately ten proposals will receive up to $1.75 million. The Foundation is also planning long-term research that is designed to explore the impact of the spill. Currently, NSF is focused on reviewing grant applications that are being submitted under the disaster-response funding stream. For more information about the grant application process see the NSF Web site.


U.S. EPA Releases Draft Formaldehyde Assessment Report
Submitted on Jun 21, 2010

Earlier this month, the U.S. Environmental Protection Agency (U.S. EPA) released a draft human risk assessment for formaldehyde that focuses on evaluating the potential toxicity of inhalation exposures to the chemical. U.S. EPA will accept comments on the draft from the public and others and the comments period will run for 90 days. The draft assessment will be reviewed by a National Academy of Sciences panel. For more information see the June 2 Federal Register.


U.S. EPA Sets Tougher Standard for Sulfur Dioxide
Submitted on Jun 21, 2010

The U.S. Environmental Protection Agency (U.S. EPA) is expected to issue a new health standard for sulfur dioxide that is designed to protect Americans from short-term exposures to SO2. U.S. EPA is expected to set the one-hour SO2 health standard at 75 parts per billion and is revoking the current 24-hour and annual SO2 health standards because the science indicates that short-term exposures are of greatest concern. Also, U.S. EPA is expected to change the monitoring requirements and will use modeling to test compliance to these new standards. For more information, see the U.S. EPA Web site.


U.S. EPA Proposed Tougher Drinking Water Standard
Submitted on Jun 21, 2010

The U.S. Environmental Protection Agency is planning to revise the national primary drinking water standard to provide more protection for pathogens going into public water systems. The proposal calls on water systems to take action when monitoring results indicate that contamination or a pathway to contamination may be present. The proposal offers incentives for better system operation and updates the conditions that would trigger public notices. For more information about the proposal, see the U.S. EPA Web site.


IUTOX Congress Update—Avoid VAT Increase and Register Today!
Submitted on Jun 18, 2010

Donna Breskin, Executive Director, IUTOX

Hopefully you have already registered to join the 12th International Congress of Toxicology in beautiful Barcelona, Spain, from July 19–23, 2010. However, if you are still considering registering, please do so today to avoid a 2% increase due to an unexpected rise in the VAT. The Spanish indirect taxes (VAT) will increase 2% on all bills emitted after July 1. Therefore, we suggest that you register by June 29, which will allow meeting organizers to bill you before July 1. Please visit the Congress Web site to register for the meeting, and we recommend you book your accommodations as soon as possible since Barcelona is a premiere destination during the summer months.

The Spanish Association of Toxicology (AETOX) and EUROTOX have put together an excellent program featuring seven CE courses, 29 symposia, and numerous special lectures, including the always engaging EUROTOX-SOT Debate. IUTOX will also convene its General Assembly where IUTOX member societies will vote for the 2010–2013 IUTOX Executive Council and also select the venues for the 2015 CTDC9 and the 2016 ICTXIV meetings.

Barcelona is situated on the Mediterranean coast in Northeastern Spain and is easily accessible to Europe and the rest of the world by land, sea, and air. Barcelona is known for its culinary delights, fantastic art, and its high quality venues, hotel facilities, and public transport. Hopefully you will take the opportunity to attend this very special and important toxicology meeting, which occurs only once every three years.

Please share this information with your members and other interested parties. IUTOX is looking forward to a fantastic meeting in Barcelona and especially seeing you there!


Conflict of Interest Rules in Research Proposed by HHS
Submitted on Jun 01, 2010

The Department of Health and Human Services (HHS) is proposing to change the regulations concerning potential conflicts of interest related to institutions and investigators and other public health service-funded research. In a Federal Register notice published on May 21, 2010, HHS states that “since the promulgation of regulations in 1995, biomedical and behavioral research and the behavioral research and the resulting interactions among Government research institutions and the private sector have become increasingly complex.” By proposing these amendments to current regulations, HHS is hoping to increase the transparency of investigator disclosure of significant financial interests, to enhance regulatory compliance and effective institutional oversight and management of investigators’ financial conflicts of interest. Comments must be submitted by July 20, 2010. For more information about the proposal, see the following PDF.


Poll Shows Majority Believe Animal Medical Testing Is Morally Acceptable
Submitted on Jun 01, 2010

The Gallup organization conducted a poll recently that shows that 59 percent of American surveyed believes that medical testing on animals is morally acceptable and 34 percent felt it is morally wrong. The results of this poll can be found on the Gallup Web site.


European Parliament Okays Animal Welfare Action Plan for 2011–2015
Submitted on Jun 01, 2010

On May 5, the European Parliament approved a resolution on the European Community Animal Welfare Action Plan for 2006–2010, which, among other things, calls for the creation of an animal welfare law that contains similar standards for domestic production and imported production. Details of the adopted resolution can be found at the European Parliament Web site.


USDA Briefs Stakeholders on Animal Welfare Act Enforcement Efforts
Submitted on Jun 01, 2010

Officials from the U.S. Department of Agriculture held a briefing recently about enhanced Animal Welfare Act efforts and also posted an Enhanced Animal Welfare Act Enforcement Plan at the USDA Web site. During the briefing, USDA officials contended that this is the age of enforcement and that the USDA Animal and Plant Health Inspection Service is committed to animal welfare and making the inspection process more consistent, efficient, and aggressive.


NTP Interagency Coordinating Committee to Hold Meeting in September on the Three Rs
Submitted on May 20, 2010

The Interagency Coordinating Committee on the Validation of Alternative Methods and NICEATM are hosting an International Workshop entitled, “Alternative Methods to Reduce, Refine and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions.” The workshop will feature plenary and workshop sessions by scientific experts from around the world. Sessions will focus on current U.S. and international regulatory requirements, available alternatives, and future research, development and validation activities that are needed to further advance the use of alternative methods for vaccine pot-licensing potency and safety testing. The workshop will be held September 14–16 at the William H. Natcher Conference Center, NIH Campus, Bethesda, MD. The public is invited to attend.


U.S. EPA Updates Insect Repellent Page in Time for Summer
Submitted on May 20, 2010

The U.S. Environmental Protection Agency (U.S. EPA) has updated its insect repellent page, which gives consumers a one-stop-shop for information on registered repellents. The page also offers updated information about mosquito and tick repellents and tips for choosing the right product. To see the page go to U.S. EPA Web site.


Pharmaceutical Mail-Back Pilot Project Report Released
Submitted on May 20, 2010

The University of Maine’s Center for Aging recently released a report on managing pharmaceutical wastes from consumers called The Safe Medicine Disposal for ME (SMDME) program. SMDME is a statewide model for the disposal of unused household medications using a mail-back return envelope system. Established through state legislation and implemented in 2007 with a $150,000 grant from the U.S. Environmental Protection Agency’s Aging Initiative, the program is authorized to handle both controlled and non-controlled medications. All drugs collected undergo high-heat incineration, according to the procedure already established for Maine’s law enforcement drug seizures.

The U.S. EPA is exploring the potential risks associated with pharmaceuticals and personal care products on the environment and human health. According to U.S. EPA officials, the pilot program is important because it provides U.S. EPA with valuable information about the types of medications that can end up in the water and affect the country’s ecosystem.


COMPETES Bill Goes Back to Committee
Submitted on May 20, 2010

H.R. 5116, the so-called COMPETES bill, which was scheduled for a vote on the House floor on May 13, was sent back to Committee with instructions and is expected to be brought back to the House floor for a vote sometime this week. The motion with instructions is a procedural tactic that gives the minority one final opportunity to amend the legislation.

H.R. 5116 contains a number of provisions to enhance science, technology, engineering, and mathematics (STEM) education and focuses on reducing gender barriers. The legislation provides scholarships and stipends to recruit math and science teachers. The bill also establishes a new grant program for colleges and universities to improve undergraduate STEM education.


100 Drugs Given to U.S. EPA by Pharmaceutical Companies
Submitted on May 18, 2010

Four pharmaceutical companies including Pfizer, GlaxoSmithKline, Sanofi-Aventis, and Merck, have provided 100 drugs to the U.S. Environmental Protection Agency (U.S. EPA) to assist in validating the U.S. EPA’s ToxCast screening tool. These drugs did not enter the marketplace because they demonstrated different levels of toxicity when the companies conducted early stage clinical trials on them. The data provided to the Agency will be screened and then compared with the results of the clinical trial results. These results will improve U.S. EPA’s ability to screen chemicals for toxicity. For more information about the screening tool see, the U.S. EPA Web site.


National Lab Day—May 2010
Submitted on May 10, 2010

Participate in National Lab Day, either on May 12 or throughout the month of May. SOT’s National Lab Day Web site provides suggestions, links, and more information. The U.S. Government has launched the National Lab Day initiative to bring scientists into K–12 classrooms to demonstrate the value of science. SOT’s Education Committee and K–12 Task Force are happy to share any ideas for activities or to help facilitate volunteer requests.


Animal Activists Sue U.S. FDA
Submitted on Apr 13, 2010

On April 12, the Mandatory Alternatives Petition Coalition, a group of animal activist groups from the U.S., filed suit against the U.S. Food and Drug Administration (U.S. FDA) in Federal court in Washington, D.C. for allegedly violating its mandatory duty under the Administrative Procedure Act. The suit claims that U.S. FDA failed to act on a petition that the group filed in November 2007 calling on the U.S. FDA to promulgate regulations for the pharmaceutical, medical device and other organizations to use non-animal testing methods, whenever such scientifically satisfactory methods are available. A Coalition spokesperson, Dr. Jarrod Bailey said, “Many reliable testing methods are available, with more in development, which can produce safer and more effective drugs than current animal methods. The coalition includes the American Fund for Alternatives to Animal Research (AFAAR), the British Union for the Abolition of Vivisection (BUAV), In Defense of Animals (IDA) and the New England Anti-Vivisection (NEAVS). For more information see www.alternatives-petition.org.


Toxic Substances Control Act Chemical Substance Inventory on the World Wide Web
Submitted on Apr 02, 2010

The Environmental Protection Agency (EPA) is making the Toxic Substances Control Act (TSCA) Chemical Substance Inventory available to the public on the Internet. The inventory includes a consolidated list of thousands of industrial chemicals maintained by EPA and is being made available to the public as part of the Administrator’s commitment to increase information on chemicals. For access to the complete inventory visit the U.S. EPA Web site.


NIH Announces Genetic Testing Registry
Submitted on Apr 02, 2010

The National Institutes of Health (NIH) is creating a public database that researchers, consumer, health care providers and others can search for information submitted voluntarily by genetic test providers. The responsibility for completing the registry has been given to the National Center for Biotechnology Information and the project is expected to be available sometime in 2011. Information about the registry is available at the NIH Web site.


EPA to Strengthen Standards for Water Quality
Submitted on Apr 02, 2010

Recently, Environmental Protection Agency (EPA) Administrator Lisa Jackson announced that EPA is developing a new set of strategies that are designed to strengthen contaminants in the nation’s drinking water. In announcing this new approach the Administrator said, “To confront emerging health threats, strained budgets and increased needs—today’s and tomorrow’s drinking water challenges—we must use the law more effectively and promote new technologies.” The new approach will focus on four strategies including the following:
  • Contaminants will be grouped and addressed together rather than one at a time.
  • New drinking water treatments technologies will be fostered to address health risks posed by a broad range of contaminants.
  • Multiple statutes will be employed to protect drinking water.
  • EPA will partner with states to share data.
The Administrator also indicated that EPA will revise existing drinking water standards for four contaminants including tetrachloroethylene, trichloroethylene, acrylamide and epichlorohydrin. All four contaminants are known to cause cancer.

For more information visit the U.S. EPA Web site.


EPA, FDA, and Others to Assess Environmental and Health Effects of BPA
Submitted on Mar 31, 2010

The Environmental Protection Agency (EPA) announced the agency will add bisphenol (BPA) to the chemical concern list on the grounds of potential environmental effects. This announcement is part of an action plan on BPA that EPA is taking as a result of concerns EPA has about the potential health efforts of this chemical. Steve Owens, Assistant Administrator of the EPA office of Prevention, Pesticides and Toxic Substances said in a statement, “Both EPA and FDA and many other agencies are moving forward to fully assess the environmental and health impact to ensure that the full range of BPA’s possible impacts are examined.”


Obituary of Roy L. Mundy, Ph.D.
Submitted on Mar 29, 2010

Charles Miller, Ph.D., Tulane University

Roy L. Mundy, Ph.D.
Pharmacologist and Toxicologist, SOT Member

Roy Lee Mundy passed away in the company of his family in Birmingham, AL, November 27, 2009. He was born March 4, 1922, in Charlottesville, Virginia. Roy was a military veteran, medical researcher, and educator. His academic training occurred at Howard College (Samford U; BS), University of Alabama (MS) and University of Virginia (Ph.D.). His military career spanned 27 years active duty, U.S. Army. He was a combat veteran of WWII who also served in Korea. In WWII Roy served under the Office of Strategic Services in China. He trained and led in combat the first Parachute Battalion, Chinese Nationalist Army. In Korea he helped establish a field laboratory for the Surgical Research Team that developed the first kidney dialysis treatments and applied them to save the lives of severely wounded soldiers. Later Roy served as the first head of the Pharmacology Department, Walter Reed Army Institute of Research (Washington, D.C.) where he led development of quinine-replacing anti-malarial drugs that protected troops in Southeast Asia. After retirement from the Army he joined the Department of Pharmacology of the Medical School of the University of Alabama at Birmingham (UAB) where he taught medical and dental students, ophthalmology residents and pharmacology graduate students. He was appointed Professor Emeritus at UAB upon his retirement. Those of us who knew Roy will miss his smile, kindness, and unique perspective on life and science.


EPA Increases Transparency of Proposed Regulations
Submitted on Mar 23, 2010

The U.S. Environmental Protection Agency (U.S. EPA) is going to launch a new Web site that will give the public additional opportunity to participate in U.S. EPA’s rulemaking process. The online Rulemaking Gateway serves as a portal to U.S. EPA’s priority rules, giving citizens more concise information earlier about the EPA’s regulations. For more information about this, see the U.S. EPA Web site.


EPA Administrator Outlines Agency’s Plans for 2010 in Letter to Hill
Submitted on Mar 23, 2010

In a letter to eight Senators regarding EPA’s plans for 2010, Environmental Protection Agency (EPA) Administrator Lisa Jackson reported that:
No facility will be required to address greenhouse gas emissions in the Clean Air Act permitting of new construction or modifications before 2011.

Only facilities that must apply for Clean Air Act permits as a result of their non-greenhouse gas emissions will need to address their greenhouse gas emissions in their permit applications.
EPA may consider modifying the rule announced last September that requires large facilities emitting more than 25,000 tons of greenhouse gases a year to obtain permits that demonstrate they are using best practices and technologies to minimize greenhouse gas emissions.


EPA and NREL to Develop Renewable Energy Production on Superfund and Brownfield Sites
Submitted on Mar 23, 2010

The U.S. Environmental Protection Agency and the National Renewable Energy Laboratory of the Dept. of Energy are exploring the feasibility to developing renewable energy production on Superfund, brownfields, and former landfill and mining sites. The two government agencies will analysis the best renewable energy technology for the site, optimal location for placement of the renewable energy technology, potential energy generating capacity, return on investment and economic feasibility of these types of projects. For more information see, the U.S. EPA Web site.


Dr. Johnson, Jr., Named Chief of Policy Advisory Group
Submitted on Mar 23, 2010

Dr. James H. Johnson, Jr., has been appointed chair of the National Advisory Council for Environmental Policy and Technology by Lisa Jackson, Administrator, U.S. Environmental Protection Agency.

Dr. Johnson is Professor Emeritus of Civil Engineering and former Dean of the College of Engineering, Architecture and Computer Sciences at Howard University in Washington, D.C.

The National Advisory Council for Environmental Policy and Technology advises the U.S. EPA on a broad range of environmental policy, technology and management issues.

For more information about the Council, see the U.S. EPA Web site.


NIH Announces New Common Fund Programs
Submitted on Mar 23, 2010

On February 25, 2010, Dr. Francis Collins, the Director of the National Institutes of Health, announced the approval of seven new scientific programs, which will be supported through the NIH Common Fund. The Fund encourages collaborative research programs across the NIH institutes and centers to accomplish work that one center or institute cannot accomplish alone. The new seven programs include the following:
  • Library of Integrate Network-based Cellular Signatures Program—Called LINCS, the program will build a community resource of scientific information to enhance understanding as to how components of biological systems function normally to maintain health and how components become disrupted by genetic and environmental stressors to cause disease.
  • Protein Capture Reagents Program—Created for new research tools, the program will produce a suite of high quality, affordable, and reliable new research tools to isolate or capture proteins in order to study their function under normal conditions and when the cell is stressed or diseased.
  • Knockout Mouse Phenotyping Program—designed to decipher how genes control certain characteristics, the program will establish a system to characterize thousands of mice that have been engineered to have specific genes turned off or knocked out. The program will also decipher how specific genes control certain characteristics such as metabolism, energy balance and physical appearance in mice.
  • Science of Behavior Change Program—designed to examine how human biology, culture and society influence the individual’s ability to adopt healthy behaviors, the program will address effective motivation strategies that might be developed to curb unhealthy behaviors such as smoking, excessive alcohol drinking, poor diet and lack of exercise.
  • NIH Induced Pluripotent tem Cell Center—Created under the NIH Intramural Research Program, the program creates a national iPS Cell Center, which will drive the translation of scientific knowledge about stem cell biology into new cell-based treatments.
  • Global Health Program—Designed to increase the capacity for global health research, the program will enhance education, training and research opportunities in developing countries.
  • Regulatory Science Program—Designed to encourage rapid new knowledge, the program will ensure the development of safe and effective products based on the highest quality science in the U.S.
Additional information about these programs is available at the NIH Web site.


NIH and FDA Collaborate to Accelerate Scientific Breakthroughs for the Public
Submitted on Mar 23, 2010

Recently, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) announced that they will establish a joint NIH-FDA Leadership Council to oversee collaborative work on important public health issues. The newly established leadership group will work together to ensure that regulatory considerations form an integral component of biomedical research planning and that the latest science is integrated into the regulatory review process. The FDA and NIH will also issue a Request for Applications and make $6.75 million available over the next three years for work in regulatory science. The research should add to the scientific knowledge base by providing new methods, model or technologies that will inform the scientific and regulatory community about better approaches to evaluating safety and efficacy in medical product development. For more information about this initiative, see the NIH Web site.


EPA Tightens NO2 Standards
Submitted on Feb 05, 2010

The Environmental Protection Agency (EPA) announced a tighter national air quality standard for nitrogen dioxide. The one-hour level will be set at 100 parts per billion and the annual average of 53 parts per billion will remain in effect. EPA is also setting new monitoring requirements in urban areas, given that NO2 is formed from vehicle, power plant and other industrial emissions. For more information about the new standard, visit the Web site.


NIEHS Issues Request for Information on Superfund Research Program
Submitted on Jan 26, 2010

The National Institute of Environmental Health Sciences has issued a Request for Information (FRI) for the Superfund Research Program as part of the strategic planning process for this program. The FRI is seeking comment on ways to prioritize science and enhance the impact of the Superfund Research Program to achieve the following objectives:
  • Define the Program mission and vision for the next five years
  • Delineate a process for selecting science
  • Establish a framework to attain scientific balance and growth
  • Establish a framework for incorporating emerging science and tools into the Program
  • Enhance research translation, community engagement and training
  • Delineate NIH meachanism for funding
For more information about the program and the RFI visit the NIH Grants Web site.


Dr. Falk to Serve as Acting Director of NCEH/ATSDR
Submitted on Jan 26, 2010

Dr. Henry Falk has been selected to serve as Acting Director of the Centers for Disease Control and Prevention’s National Center for Environmental Health (NCEH). The Center plans, directs, and coordinates a national program to maintain and improve the health of the American people by promoting a healthy environment and by preventing premature death and avoidable illness and disability caused by non-infectious, non-occupational environmental and related factors. Dr. Falk has served several roles at the NCEH and was the Director from 2003–2005. He will serve as the acting director until a replacement is selected.


SOT Members Urged to Contact U.S. Representatives to Oppose Great Ape Bill
Submitted on Jan 26, 2010

H.R. 1326, the Great Ape Protection Act, which was introduced in the U.S. House of Representatives on March 5, 2009, is gaining sponsors in the House because of a letter writing campaign that activist groups are generating. Under this bill, all invasive research involving great apes would be banned, including blood draws and tissue collection.

SOT members are asked to contact their Members of Congress and urge them not to support this legislation. Some of the points that SOT members may want to include are:

  • Although the number of chimpanzees essential to biomedical research is very few, chimpanzees remain the only valid research model for developing vaccines that prevent infection by the hepatitis C virus, from which millions of people worldwide suffer.
  • Chimpanzee models have led to major medical advances; as a case in point, thanks to chimpanzee research, there are vaccines for hepatitis A and B. Preventing research with chimpanzees would slow or eliminate urgently needed research, including a vaccine for hepatitis C. According to the CDC, 3.2 million Americans are infected with hepatitis C virus. Hepatitis C is the leading cause of liver transplantation and is responsible for 10,000 to 20,000 deaths per year in the U.S.
  • Scientists also rely on chimpanzee models for the development of vaccines for malaria, human cytomegalovirus, respiratory syncytial virus, and some forms of cancer.

To find out who your U.S. Representative is, go to the Congress Outreach section of the SOT Web site and you will receive further instructions.



EPA Administrator Outlines Seven Priorities for 2010 and Beyond
Submitted on Jan 26, 2010

In a recent memorandum to her staff, Environmental Protection Agency Administrator Lisa Jackson outlined the seven priorities that “will guide our work in 2010 and the years ahead.” Calling them challenges and opportunities, the Administrator detailed the following themes as focal points for EPA’s work:

Taking Action on Climate Change: Focus will continue to be on greenhouse gas reduction initiatives, enactment of the clean energy and climate legislation, finalization of the mobile source rules, and development of common-sense solutions for reducing GHG emissions from large stationary sources.

Improving Air Quality: Work will be the development of a comprehensive strategy for a cleaner and more efficient power sector, stronger emission reduction goals for SO2, NOx, mercury, and other air toxics, stronger ambient air standards for pollutants like PM, SO2 and NO2, reductions in air emissions from a broad range of industrial facilities and stronger health assessments on dioxins, arsenic, formaldehyde, TCE and others.

Cleaning Up Communities: Focus will be to accelerate strategy for Brownfield program, and enhance strategies for the Superfund program.

Protecting America’s Waters: Efforts will be to continue the watershed protection programs for the Chesapeake Bay and Great Lakes. EPA will initiate programs to address post-construction runoff, water quality impairment from surface mining, and the development stronger water quality protection.

Expanding Environmentalism and Environmental Justice: Thrust of the work will be to include environmental justice policies in all policy decisions, increase protection of vulnerable subpopulation groups, and revitalize the Children’s Health Office.

Strengthening Tribal Partnerships: Focus will be the development of stronger partnerships with state and tribal governments and stronger state and tribal environmental protection.

Improving EPA’s Internal Organization: EPA efforts will be to enhance internal operations.

For more information about the Administrator’s memorandum, visit the EPA Web site.



NIEHS/NTP Director and Staff to Provide Live Updates at SOT Annual Meeting
Submitted on Jan 22, 2010

National Institute of Environmental Health Sciences (NIEHS) and National Toxicology Program (NTP) representatives including Director Linda Birnbaum, Ph.D., will be providing LIVE updates throughout the upcoming SOT conference in Salt Lake City. These scientists and grant administrators will be sharing information and insights on the events at the conference—from the first keynote speech to the last workshop. They’ll be reporting on all the innovations, the breakthrough research, and the interesting people that make SOT so unique!

“These live updates will showcase all the fantastic things that are happening in the field of toxicology,” said Birnbaum. “I hope we can be the eyes and ears for people who want an up close and personal look at the conference—especially if they can’t be there in person.”

Beginning in March the links will be live, look for updates and pictures at www.niehs.nih.gov/LiveatSOT or follow along at www.Twitter.com/LiveatSOT.

See you in Salt Lake!


SOT Prepares for 50th Year Anniversary Celebration
Submitted on Jan 14, 2010

2011 will mark the 50th Anniversary of the Society of Toxicology and SOT is taking steps to ensure that the 50th Anniversary is a memorable occasion for SOT members.

The 2011 Annual Meeting and ToxExpo will be held March 6–10, 2011, at the Walter E. Washington Convention Center. Special events for this 50th Anniversary celebration include an SOT Anniversary Book, an Anniversary Brochure, a Celebration Evening, Commemorative Posters, Exhibits, History of Toxicology Session and, as always, a comprehensive scientific program and other special activities. SOT is asking SOT Committees to think about activities and special products they might want to include for this one time event.


SOT Responds to OSTP Request About Public Access to Science
Submitted on Jan 14, 2010

On January 21, SOT filed comments in response to the Office of Science and Technology’s (OSTP) request for public comment on public access policies for science and technology funding agencies across the federal government.

OSTP solicited public input on ways the federal government can improve public access to scientific research and pointed out, “increasing the public access to scholarly publications resulting from federally funded research may enhance the return on federal investment in research.”

SOT responded by indicating that the Society supports the National Institutes of Health (NIH) model, which grants public access to all articles published in the Toxicological Sciences (ToxSci) journal 12 months after print publication. SOT noted that this system “eliminates burdens on individual authors, pays for robust peer review and allows not-for-profit publishers to use any remaining profits to support science worldwide, including such things as scholarships, dissemination of information, grants, educational outreach, advocacy for research funding, and improvement in scientific publishing.” SOT pointed out that ToxSci has an open access submission option that allows authors to pay a fee to make articles available to the public after acceptance. ToxSci assists authors whose research was funded by NIH by depositing their accepted manuscripts in PubMed central and transmits papers directly to the NIH.


Dr. Anastas Confirmed as Head of EPA Office of Research and Development
Submitted on Jan 14, 2010

After some delay, the Senate has confirmed Paul Anastas to head up the Environmental Protection Agency’s (EPA) Office of Research and Development. Dr. Anastas is widely known as an expert in “green chemistry” and is currently the Director, Center for Green Chemistry and Green Engineering Teresa and H. John Heinz III Professor in the Practice of Chemistry for the Environment, School of Forestry & Environmental Studies. He has been a faculty member of Yale University since 2007.

Sen. David Vitter (R-LA) had blocked Dr. Anastas’ confirmation because he was concerned that the EPA had not yet completed an assessment of the risks associated with formaldehyde, which was found in the trailers that the Federal Emergency Management Agency gave victims of Hurricane Katrina.


Novel, State-of-the-Art Advances in the Science of Toxicology Highlighted at SOT 2010
Submitted on Jan 06, 2010

Each year the Scientific Program Committee (SPC) receives multiple requests from our membership as well as Annual Meeting attendees to accept additional abstracts for presentation. This year is no different and the SOT Council, with a strong recommendation from the SPC, will begin accepting abstracts beginning Monday, January 11. The deadline for all submissions will be February 15, 2010. Authors have the option to submit an abstract(s) either as a late breaking or grace period submission:

  • Late breaking abstracts are defined as those abstracts deemed to be novel, state-of-the-art research whose results were not available before the October submission deadline.
  • Grace period abstracts are defined as those abstracts that scientists had to wait until after the abstract deadline to determine if funding was available for SOT Annual Meeting attendance or those who have new travel restrictions stating that they can only attend a meeting if they are presenting an abstract.

Abstracts submitted for the “late breaking” category that are not accepted will automatically be considered for the “grace period” category. All abstracts must be submitted on-line via the abstract submission Web site.

All abstracts accepted during this final submission phase will only be accessible through the On-line Itinerary Planner with copies of the abstract titles provided as a supplement at the Registration area at the Salt Palace Convention Center. Within the 2010 sessions, SOT will present over 2,200 abstracts. We look forward to welcoming you to Salt Lake City and hope that you will consider submitting your abstracts.

Sincerely,

Michael Holsapple

Chairperson, SOT Scientific Program Committee
SOT Vice President

Jon C. Cook

Co-Chair, SOT Scientific Program Committee
SOT Vice President-Elect



NIH Alert—Major Changes to NIH Applications: Be Prepared
Submitted on Dec 18, 2009

Dear NIH principal investigators, signing officials, and applicants,
Are you planning to submit an NIH grant application? If so, please note that all applications intended for due dates on or after January 25, 2010*, require the use of new forms and instructions. Major changes include:
  • Restructured forms to align with review criteria
  • Significantly shorter page limits
These changes apply to all competing applications, so whether you are submitting a new, renewal, resubmission or revision, you must take action now to ensure a successful submission!
  1. Return to the updated funding opportunity announcement or reissued parent announcement to download the new application package and instructions.
    • FOAs are in the process of being updated. See timeline for more information.
  2. Be sure to choose the correct forms. Applications intended for due dates on or after January 25 require new forms.
    • For Electronic SF 424 (R&R): ADOBE-FORMS-B
    • For Paper PHS 398: Revision date “June 2009”
  3. Read the updated FOA and new application instructions carefully
For more details the Enhancing Peer Review Web site which has a page dedicated to the upcoming application changes, as well as a number of additional resources including: Sincerely,

NIH Office of Extramural Research
Division of Communications and Outreach

* Applicants eligible for continuous submission who are submitting R01, R21, and R34 AIDS applications should use the old SF 424 (R&R) ADOBE-FORMS-A on or before February 7, 2010 and the new SF 424 (R&R) ADOBE-FORMS-B thereafter. Non-AIDS applications from applicants eligible for continuous submission need to us ADOBE-FORMS-A on or before January 24 and the ADOBE-FORMS-B on or after January 25, 2010.


CDC Releases Fourth National Report on Human Exposure to Environmental Chemicals
Submitted on Dec 07, 2009

The Centers for Disease Control and Prevention (CDC) will release its Fourth National Report on Human Exposure to Environmental Chemicals on Thursday, December 10, 2009. The report includes data on the U.S. population’s exposure to environmental chemicals from the National Health and Nutrition Examination Survey for the U.S. population over a two-year survey period of 2003–2004 as well as exposure data from the two previous reports, which cover 1999–2002.

A complete listing of chemicals that are included in the Fourth National Report. The report will also be available December 10, 2009, on the CDC Web site.



Eric Green New Head of the National Human Genome Research Institute
Submitted on Nov 20, 2009

The National Institutes of Health announced that Eric D. Green, M.D., Ph.D. has been selected to be the director of the National Human Genome Research Institute (NHGRI). Dr. Green currently serves as the Institute’s scientific director and the head of the Genome Technology Branch and the head of the Branch’s Physical Mapping Section. In addition to the work Dr. Green does relative to genomics, his laboratory also investigates genetic contributions to human illness. He is the recipient of several awards and is the author of more than 240 scientific papers. He is also a founding editor of the Genome Research in 1995 and co-editor of the Annual Review of Genomics and Human Genetics. For more information see the NIH Web site.


EPA Proposes Stronger Standards for Sulfur Dioxide
Submitted on Nov 20, 2009

The Environmental Protection Agency (EPA) is proposing a new sulfur dioxide air quality standard that will affect power plants and other industrial facilities. EPA is opening the public comment period on a proposal to establish a new national one-hour SO2 standard, between 50 and 100 parts per billion and would eliminate the current 24-hour and annual SO2 annual standard. Monitoring and reporting requirements would change under the proposal and the public comment period will be open for the next 60 days. For more information about the EPA proposal, visit the EPA Web site.


The National Academies Announces New Project for Scientific Publications Involving Animal Studies
Submitted on Nov 19, 2009

The National Academies’ Institute for Laboratory Animal Research (ILAR) has announced a new project titled "Guidelines for Scientific Publications Involving Animal Studies." The project, sponsored by the U.S. Department of Health and Human Services, will include preparation of a short committee report directed at editors of journals that publish animal studies. The report will outline the information that should be included in scientific papers regarding the animal studies to make certain that the study can be replicated. The extent of the necessary information will be decided by the committee, and will include things such as, conditions of housing and husbandry, genetic nomenclature, microbial status, detailed experimental manipulations, and handling and use of pharmaceuticals. Evidence-based rationale for the need to include this information will also be presented.

Read about the National Academies’ announcement of this project.



In Memoriam: SOT Charter Member and Past President Gabriel L. Plaa Passed Away
Submitted on Nov 13, 2009

November 12, 2009

Gabriel L. Plaa

Gabriel Leon Plaa, a prominent educator and toxicologist, died of cancer in Montreal, Canada. He was 79 years of age.

Gabriel L. Plaa was born May 15, 1930, in San Francisco to immigrants from France and thus French was his first language. He graduated from the University of California in 1952 with a B.Sc. in criminalistics. As a veteran of the Korean War, Dr. Plaa returned to the University of California for graduate studies in criminalistics. While attending a course taught by Dr. Charlie Hine, he was given the choice of remaining a graduate student in criminalistics without a stipend, or becoming a graduate student in pharmacology and toxicology with a stipend. Dr. Plaa became a toxicologist, earning his M.Sc. in 1956, and his Ph.D. in 1958 in Comparative Pharmacology and Toxicology with Dr. Charlie Hine as his mentor.

Dr. Plaa was an Instructor and Assistant Professor at Tulane University from 1958–1962, and then was assistant and associate professor at the University of Iowa from 1962–1968. In 1968, Dr. Plaa moved to the University of Montreal where he was Chairman of Pharmacology for 12 years. Over the years, he held other administrative positions at the university including Vice-Dean of Research and Graduate Studies, all the while conducting an active research program. The University of Montreal acknowledged his achievements and named him Professor Emeritus in 1996. In 2003, on the occasion of the 125th anniversary of its founding, the University of Montreal recognized Dr. Plaa as one of the pioneers of the institution.

Dr. Plaa was extraordinarily charitable with his time for the advancement of science nationally and internationally. He served on various scientific committees for the Society of Toxicology (SOT), NIH, ASPET, Society of Toxicology of Canada (STC), MRC, NAS, FASEB, WHO, IUPHAR, and IUTOX. He was on the editorial board of nine scientific journals, served as Associate Editor of Toxicology and Applied Pharmacology, Journal of Pharmacology and Experimental Therapeutics, and Canadian Journal of Physiology and Pharmacology, and was Editor of TAAP from 1972–1980. Dr. Plaa was President of the STC (1981–1983) and SOT (1983–1984).

Dr. Plaa’s research focused on chemical-induced liver injury. With his Ph.D. dissertation, he was the first scientist to study hepatotoxicity using an isolated perfused liver. He made significant contributions in the 1) dose-response characteristics of hepatotoxicity, 2) catecholamines and carbon tetrachloride hepatotoxicity, 3) dye clearance technique for assessing hepatic function, 4) potentiation of haloalkane hepatotoxicity, 5) ANIT-induced cholestasis, 6) the manganese-bilirubin model of cholestasis, and 7) potentiation of chemically- induced cholestasis. Dr. Plaa published 233 peer-reviewed manuscripts, wrote 48 chapters and literature reviews, and edited five books. He received the first Achievement Award from the SOT (USA) in 1967, an award which recognizes promising young scientists. That recognition was affirmed when in 1996 he received the Society’s highest award, the Merit Award which recognizes career length contributions to the science and profession of toxicology. In the intervening years he received the Arnold Lehman Award (1981) for his use of sound scientific principles in risk assessment and regulation of chemicals, and the Education Award (1987) for his teaching and training of toxicologists. Similarly in Canada, he received from the STC the VE Henderson Award (1969), the STC Award of Distinction (1984), and was named honorary president of ICT-XI in Montreal (2007).

Dr. Plaa had high expectations, first for himself and then for those he related to; he relayed these expectations with a witty sense of humor that was inspiring and stimulating. Dr. Plaa summarized his scientific career in an article entitled “A four-decade adventure in experimental liver injury” published in Drug Metabolism Reviews 29: 1–37, 1997 in which he concluded “the most satisfying ‘results’ of my research program are not the data or new observations acquired, but the graduate students and fellows with whom I collaborated over a span of nearly 40 years. I am forever grateful for their precious presence and participation in my laboratory.” Gabbie’s influence in training toxicologists was extraordinary. Two of his Ph.D. students later received Achievement Awards from the SOT (Klaassen and Charbonneau), and five graduate students in the pharmacology-toxicology program during Gabbie’s six years at the University of Iowa were later elected Presidents of SOT (Dixon, Gibson, Hook, Klaassen, and McClain).

Dr. Plaa retired from the University of Montreal in 1996. During the last 13 years of his life, he cared for his wife, Colleen, who has multiple sclerosis, much as she cared for Gabbie during his decades in science. Gabbie was also the loving father of eight children, Ernest, Steven, Kenneth, Gregory, Andrew, John, Denise, and David, as well as a grandfather of eight.

Gabbie Plaa had an enormous influence on his children, his “academic children,” as well as the entire toxicology community. We all will miss him, but his contributions to society will survive us all.



NIH/NIEHS Request Nominations for Interagency Breast Cancer and Environmental Research Coordinating Committee—Deadline December 1
Submitted on Oct 16, 2009

The October 16, 2009, Federal Register [74 FR 53283] announced that the National Institute of Environmental Health Sciences (NIEHS) of the National Institutes of Health (NIH) is requesting nominations for members to serve on the Interagency Breast Cancer and Environmental Research Coordinating Committee. This Committee will coordinate information on existing activities related to breast cancer and environmental research and make recommendations to the National Institutes of Health and other Federal agencies on how to improve existing research programs. Nominations received on or before December 1, 2009 will be considered in a pool of candidates gathered from numerous sources for membership on the Committee. Nominations received after December 1, 2009 will be considered for future vacancies. For more information, please refer to the Federal Register notice.


EPA Launches New Evaluation on Pesticide—Artazine
Submitted on Oct 15, 2009

On October 7 the Environmental Protection Agency announced that the Agency will conduct a major evaluation of a common pesticide, atrazine, to determine whether new restrictions are necessary to better protect human health. Atrazine, is a common agricultural pesticide that is used widely in the U.S. The Agency plans to evaluate the potential cancer and non-cancer effects on humans and its potential association with birth defects, low birth weight and premature births. EPA will examine data generated since 2003 from laboratory and population studies and will seek the advice of an independent Scientific Advisory Panel to evaluate the human health effects of atrazine in 2010. For more information about the evaluation see the EPA Web site.


Final Rule on Aircraft Drinking Water Issued
Submitted on Oct 15, 2009

The Environmental Protection Agency (EPA) has issued a final rule on drinking water in aircraft public water systems that are servicing the public and crew members. The final rule calls for coliform sampling, best management practices, corrective action, public notification, monitoring and operator training. The final regulations track existing health-based drinking water regulations, but are tailored for aircraft public water systems. These public systems are subject to the requirements of the National Primary Drinking Water Regulations. For more information go to the EPA Web site.


FDA Issues Risk Communication Plan
Submitted on Oct 15, 2009

The Food and Drug Administration (FDA) has issued a strategic plan for risk communication to bolster how the FDA informs the public about regulated products. Using this strategy, FDA hopes to “empower the public by providing healthcare professionals, patients, and consumers with the information they need about FDA-regulated products, in the form they need it, when they need it.” Information about the strategy is available on the FDA Web site.


National Environmental Public Health Conference Slated for October
Submitted on Oct 15, 2009

The Centers for Disease Control's National Center for Environmental Health and the Agency for Toxic Substances and Disease Registry in conjunction with the National Environmental Health Association are hosting a National Environmental Public Health Conference, Oct. 26-28 in Atlanta. If you are not able attend you can listen to Keynotes and plenary sessions by webcasts. To register for these webcasts, please visit the following Web site.


EPA Launches Nanomaterial Strategy
Submitted on Oct 01, 2009

On September 29, The U.S. Environmental Protection Agency (EPA) announced a new research strategy that highlights what research EPA will support to help determine what impact manufactured nanomaterials have on human health and the environment. The new strategy and research, which will be conducted in EPA’s laboratories, will also examine how nanomaterials can be used clean up contaminants in the environment.

EPA applies a multidisciplinary approach to research examining all aspects of nanomaterials in the environment, from their manufacture and use to their disposal or recycle. More information about nanotechnology research, visit the EPA Web site.


EPA Strengthens and Enhances Chemical Management Law and the Management Program
Submitted on Oct 01, 2009

Environmental Protection Agency (EPA) Administrator Lisa Jackson is taking steps to strengthen the Agency’s U.S. chemical management laws on a number of fronts. As part of the new regulatory risk management plan, the Administrator is instituting new regulatory risk management actions on the following chemicals:
  • Lead—Strengthen the lead paint work practice standards for renovation and remodeling that were issued in 2008. Initiate a TSCA Section 6 rulemaking to ban the use of lead weights in tires.
  • Mercury—Open a TSCA Section 6 rulemaking to phase out and/or ban the use of mercury in a range of switches, relays, measuring devices and other products.
  • Formaldehyde—Open a rulemaking on formaldehyde emission from pressed wood products.
  • PCBS—Initiate a TSCA Section 6 rulemaking to re-evaluate regulations relating to TSCA PCB use and distribution in commerce.
  • Glymes—Open a TSCA Section 5(a) (2) rulemaking that will require prior notification to the EPA of any new consumer use of monoglyme, diglyme and EDGE.
  • Nanomaterials (carbon nano tubes)—Initiate Section 5(a)(2) rulemaking to require protective measures to limit exposure or ban exposure of two carbon nano tube chemical structures.
  • EPA also intends to develop chemical action plans for Benzidine dyes and pigments, Bisphenol A, penta, octa, and decabromodiphenyl ethers in products, perfluorinated chemicals, phthalates, and short-chain chlorinated paraffims. Using regulatory mechanisms under Section 6 of TSCA, EPA will address other chemicals using their authority to ban, label, restrict or ban these chemicals. EPA also intends to require that companies submit information to fill the remaining gaps in basic health and safety data on HPV chemicals, mandate the reporting of chemical use information more transparent, current, useful and usable by the public.

    More information about the Administrator’s plans is detailed during a speech she gave at the Commonwealth Club in San Francisco yesterday.


    ILSI Foundations Seeks Peer Consultation Panelists
    Submitted on Sep 24, 2009

    The ILSI Research Foundation is seeking nominations for a peer consultation panel following ILSI’s selection as the administrator of a panel to review the biodegradation testing of certain fluorotelomer-based products under an agreement between E.I. DuPont de Nemours and Company and the U.S. Environmental Protection Agency. Scientists with experience in biodegradation testing, environmental fate of polymers, laboratory analysis and characterization of polymers, and fluorotelomer/fluoropolymer chemistry are likely candidates. as well as those with experience evaluating data from semi-continuous activated sludge and related studies. A detailed curriculum vitae and completed Conflicts of Interest Questionnaire must be submitted to sep_panel@ilsi.org by October 26.


    Clarification on REACH Regulation Issued
    Submitted on Sep 18, 2009

    The European Chemicals Agency (ECHA) issued a press release September 15 regarding the REACH regulation concerning companies that manufacture or import substances at quantities great than or equal to 100 tonnes and 1000 tonnes that clarifies that they do not need to submit results of screening or short-term studies in order for their submission to be considered "complete" by the Agency. For more information about this development, visit the ECHA Web site.


    NIH Releases Funding Tool
    Submitted on Sep 18, 2009

    The National Institutes of Health (NIH) released an online funding information tool for grants and contracts called RePORTER, that allows users to locate descriptions and funding details on NIH-funded projects along with research results that cite the NIH support. With improvements to the system, users will be allowed to personalize their experience, save favorite searches, set alerts for new grants publications and patents and export the entire database. For more information visit the NIH Web site.


    Dr. Alexander Announces Departure from NICHD
    Submitted on Sep 18, 2009

    Dr. Duane Alexander, Director of the National Institute of Child Health and Human Development (NICHD), announced today that he will be leaving the Institute on September 30 to begin a new job as a Senior Scientific Advisor on Global Maternal and Child Heatlh Research at the Fogarty International Center. Dr. Susan Shurin, Deputy Director of the National Heart, Lung, and Blood Institute, will serve as the acting director upon his departure.

    Dr. Alexander will be working with Director Roger Glass of the Fogarty International Center to implement a new initiative at the National Institutes of Health, which is part of a White House $634 billion Global Health Initiative to reduce maternal and child mortality in developing countries.


    NLM Resource Update: WISER 4.3 Is Now Available
    Submitted on Sep 02, 2009

    WISER 4.3 is now available. It can be downloaded from the WISER Web site or accessed at WebWISER.

    Highlights of this version include:
    • New and improved user interface for WISER for Windows
      • The Known Substance and Help Identify Unknown Chemical result lists are always visible, reducing unnecessary navigation
      • An enhanced data menu maintains the context of the previous selection and can be kept open for quick navigation
      • Substances can now be compared directly using a synchronized data menu
      • Substance tabs and new auto-arrange features allow viewing of multiple substances
    • All WISER platforms include data updates based on the latest NLM Hazardous Substances Data Bank (HSDB), Center for Infectious Disease Research and Policy (CIDRAP) for biological agents, and US Environmental Protection Agency Acute Exposure Guideline Levels (EPA AEGLs) content.
    Please contact us if you have suggestions for additional features or for enhancing current features.

    You can follow the National Library of Medicine Specialized Information Services Division, including WISER, on Twitter.

    WISER (Wireless Information System for Emergency Responders) is a system designed to assist first responders in hazardous material incidents. It provides a wide range of information on hazardous substances, including substance identification support, physical characteristics, human health information, and containment and suppression advice.


    FDA Offers Fellowship Program
    Submitted on Sep 02, 2009

    The Food and Drug Administration offers a two-year Fellowship Program for doctoral level health professionals and scientists who want training and experience at the Food and Drug Administration. Fellows will train at the agency’s state-of-the-art White Oak campus in Silver Spring, MD or other FDA facilities. Fellows receive travel funds, a benefits package and salaries that are competitive. Coursework is combined with the development of a regulatory science project. Course work is geared to give Fellows an understanding of the science behind regulatory review and the work covers foods, drugs, devices, biologics, and cosmetics and includes graduate level public policy, FDA policy, epidemiology, clinical trials and design and statistics.

    To be eligible, applicants must have a Doctoral level degree, be U.S. citizens or non-citizen nationals of the U.S. or have been admitted to the U.S. for permanent residence before the program state date. For more information see www.fda.gov.


    Food and Drug Administration Establishes Tobacco Products Advisory Committee
    Submitted on Aug 27, 2009

    On August 26, the Food and Drug Administration established a Tobacco Products Scientific Advisory Committee as mandated by the Public Law 111-31, the Family Smoking Prevention and Tobacco Control Act. The committee will be responsible for reviewing and evaluating safety, dependence, and health issues relating to tobacco products and will provide advice, information and recommendations to the FDA Commissioner. The new group will consist of 12 members including the Chair. Nine of the Committee members will include technically qualified voting members who will be selected by the Commissioner or designee. These individuals will include physicians, dentists, scientists, or health care professionals who practice in the fields of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction or other relevant specialties. Three members will consist of non-voting representatives from the tobacco manufacturing industry, the tobacco growers and the small business tobacco manufacturing industry.


    FDA Seeks Nominations for Tobacco Advisory Committee
    Submitted on Aug 27, 2009

    The Food and Drug Administration (FDA) is requesting nominations for members to serve on the newly established Tobacco Products Scientific Advisory Committee in the Office of Science, Center for Tobacco Products. The Agency is interested in securing nominations from women, minority groups and individuals with disabilities. Almost all members who are selected will serve as Special Government Employees.


    The Nomination Process for the Tobacco Advisory Committee
    Submitted on Aug 27, 2009

    Individuals may nominate one or more qualified persons and self-nominations are accepted. Individuals should submit current resumes or curriculum vitae of each candidate and individuals must ensure that nominees are award of their selection for this process unless the nomination is self-nominated. Nominations must include current business address and/or home address, telephone number and e-mail if available. In addition, the Agency will ask potential candidates to provide detailed information relating to financial holdings, employment, research grants and or contracts. All nominations must be submitted by October 12, 2009.


    SOT Lends Support to Africa Education Initiative
    Submitted on Aug 27, 2009

    The Society of Toxicology provided a grant to the Africa Education Initiative (NEF), which in part enabled the organization to hold its bi-annual Conference on Pharmaceutical Drug Discovery and Development in Nigeria. NEF is a U.S. non-profit organization dedicated to promoting science and research in Africa and this is the second time SOT partnered with the organization to support student programs in toxicological research.

    The conference was held at the National Veterinary Research Institute (NVRI) Vom, Plateau State, a premier institution known for its vaccine research and production. During the conference, NEF and NVRI launched the Toxicology Internship Programme, which will allow six students from four African countries to train in the science of toxicology. Students, who were awarded grants, include Arowolo Adefunke, Nwatu Loveth and Makoshi Shehu, ASdanyeguh Isaac, Abongwua Melaine and Gafer Ahmed. The Institute also received laptops and textbooks to help in training. The three-month toxicology internship will tech students how to plan, direct and run toxicology studies. The student interns are expected to submit an abstract of their work at the end of their training. Additional information about the conference is available at www.nef3.org.


    SOT Members Part of State Effort to Regulate Hazardous Air Pollutants
    Submitted on Aug 27, 2009

    Drs. Kimber White and John Morris, two members of the Society of Toxicology, have been selected to serve on the Virginia Inhalation Toxicology Advisory Group, which is charged with facilitating the development of a scientifically-based approach to regulate hazardous air pollutants. Virginia currently regulates hazardous air pollutants based on Significant Ambient Air Concentrations, the values of which were devised more than 20 years ago to serve as workplace thresholds limit values for chemicals. The Advisory Group has been asked to update the process for deriving these thresholds.


    Grants.gov Web Site Offers New Feature for Information on Applying for All ARRA Federal Grants
    Submitted on Aug 03, 2009

    Department of Health and Human Services

    Contact: HHS Press Office
    Phone: (202) 690-6343
    For Immediate Release: Monday, August 3, 2009

    HHS Secretary Kathleen Sebelius today unveiled a new feature on Grants.gov to help users find and apply for The American Recovery and Reinvestment Act (ARRA) grant opportunities. Grants.gov contains information about finding and applying for all federal grant programs.

    The launch of this Recovery Act feature on the homepage of Grants.gov will direct users to Recovery Act opportunities, other Recovery Act resources, upcoming Webinars, and links to Recovery.gov.

    “Grants.gov is the single government-wide source for information about grant programs across the federal government,” Secretary Sebelius said. “Many agencies and departments across government are working together to bring this information to the public. Now we are making it easier for individuals to find critical and time sensitive Recovery Act grants from all over government on the Grants.gov page with new technical improvements to the site and an aggressive outreach campaign to the public.”

    Working together across government to provide additional information to new grant applicants, HHS will host on behalf of Grants.gov a Webinar series on Aug. 13, 18, and 20, 2009. The Webinar sessions are targeted towards potential grant applicants.

    The Webinar series topics include Introduction to Grants.gov and the Recovery Act, Finding Recovery Act Opportunities and Registration to Submit Recovery Act Opportunities. Each Webinar session will include time for questions and answers.

    All Webinars will be recorded and made available to view on Grants.gov after each series is completed. More details for registration can be found on Grants.gov in the new Recovery Act feature on the homepage.

    HHS is the managing partner of the cross-agency Web site, which now has information about more than 1,000 available grant programs involving all 26 federal grant-making agencies. These agencies together award more than $500 billion in grant funds annually.


    EPA To Hold Public Hearings on National Ambient Air Quality Standards for Nitrogen Dioxide
    Submitted on Jul 29, 2009

    The U.S. Environmental Protection Agency will hold two public hearings—on August 3 in Arlington, Virginia, and August 6 in Los Angeles, California—about the Agency’s proposal to strengthen the nation’s nitrogen dioxide (NO2) air standards to protect public health.

    The proposed revisions would establish, for the first time, a one-hour NO2 standard, at a level between 80 and 100 parts per billion (ppb) and would retain the current annual standard of 53 ppb.

    These proposed standards would protect public health by reducing people’s exposure to high short-term concentrations of NO2—which generally occur near major roads—and assure that community-wide NO2 concentrations remain below levels that may cause public health problems.

    The two public hearings are an opportunity for people who want to speak in person about the proposed NAAQS/NO2 rule. Both hearings will begin at 9:00 AM and end at 9:00 PM local time.

    For those who want to speak at a particular time, contact Tricia Crabtree via e-mail or call (919) 541-5688. In addition, people may register in person on the day of the hearing; however, they may not be given a specific time to speak.

    Public Hearings:

    August 3: Arlington, VA (9:00 AM–9:00 PM Eastern)
    EPA Potomac Yard South Conference Center
    2777 S. Crystal Drive
    Arlington, VA 22202
    Note: Anyone attending the Arlington hearing will need to bring photo identification.

    August 6: Los Angeles, CA (9:00 AM–9:00 PM Pacific)
    Sheraton Los Angeles Downtown
    711 South Hope Street
    Los Angeles, CA 90017

    Written Comments: EPA also will accept written comments on the proposed rule until September 14, 2009. For more information on the proposed rule and instructions for submitting written comments go to the EPA Web site.


    EPA to Reconsider Monitoring Requirements for Airborne Lead
    Submitted on Jul 22, 2009

    U.S. Environmental Protection Agency

    Contact: Cathy Milbourn
    Phone: (202) 564-7849 | Fax: (202) 564-4355

    For Immediate Release: July 22, 2009

    The agency seeks to protect the nation’s children WASHINGTON—To ensure the most vulnerable Americans are adequately protected from exposure to lead from the air, EPA will reconsider some of its lead air pollution monitoring requirements, Administrator Lisa P. Jackson announced today. Even at low levels, lead exposures can damage a child’s IQ, learning and memory.

    “We have a fundamental responsibility to protect every child from environmental threats, especially contaminants like lead that can cause behavioral and learning disabilities and create a lifetime of challenges,” said EPA Administrator Lisa P. Jackson. “We’re putting in place rigorous standards to prevent contamination. To make them fully effective, we need close interaction and monitoring in the communities where harmful levels of airborne lead are most likely to be found.”

    Air quality monitoring measures concentrations of a pollutant in the outdoor air. EPA revised its air quality monitoring requirements for lead in 2008, at the same time the agency tightened the national air quality standards for lead for the first time in 30 years. The current rule requires air quality monitoring in areas where any industry emits at least one ton of lead to the air each year, and in the 101 urban areas with populations of 500,000 or more.

    As part of today’s action, EPA will consider whether additional monitoring near industrial sources of lead is warranted. The agency also will reconsider the monitoring requirements for urban areas as part of its review. EPA is not reconsidering the lead standards.

    Lead that is emitted into the air can be inhaled or can be ingested after it settles out of the air. Ingestion is the main route of human exposure. Children are the most susceptible because they are more likely to ingest lead and their bodies are developing rapidly. Exposures to low levels of lead early in life have been linked to damage to IQ, learning, memory and behavior. There is no known safe level of lead in the body.

    The reconsideration will not delay implementation of the 2008 lead standards. EPA will issue a proposal and take public comment before deciding whether to revise the lead monitoring requirements. The agency anticipates issuing a proposal for public review and comment later this summer, and a final rule in early spring 2010.

    More information please visit the EPA Web site.


    NAS Establishes Committee on Use of Emerging Science for Environmental Health Decisions
    Submitted on Jul 08, 2009

    The National Academy of Sciences (NAS) recently established the NAS Committee on the Use of Emerging Science for Environmental Health Decisions, in part, as a response to the "NRC 2007 Toxicity Testing in the 21st Century" and the NRC 2007 Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment." The new Committee was established to facilitate communications among government, industry, environmental groups and the academic community. For more information about this new Committee, visit the Web site.


    You Can Take Action! Petition Champions Vital Need for Animals in Research
    Submitted on Jun 29, 2009

    Since late April 2009, over 9,000 people have signed the Pro-Test Petition that lists among its sponsors the Americans for Medical Progress, of which SOT is a member. The Pro-Test Petition gives you the opportunity to show your support for the scientists and your opposition to the use of threats and violence in the ongoing debate over the use of animals for biomedical research.


    Videocast of the May 6 Hazardous Substances Data Bank Symposium Now Available
    Submitted on Jun 03, 2009

    A videocast of the Hazardous Substances Data Bank Symposium, held May 6, 2009 at the National Library of Medicine in Bethesda, MD, is now available. (Runtime 210 minutes)

    "The Hazardous Substances Data Bank: Historical Aspects and Future Role as a Toxicology and Environmental Science Resource" symposium was part of the commemoration of the 75th meeting of the Hazardous Substances Data Bank (HSDB) Scientific Review Panel (SRP). It includes presentations on the history and current use of HSDB as well as an analysis of its data. The symposium also provides a discussion by a panel of experts from government and non-government organizations exploring future opportunities for HSDB data enhancement.

    The Hazardous Substances Data Bank (HSDB) contains over 5,000 records of information on potentially hazardous chemicals including information on human exposure, industrial hygiene, emergency handling procedures, environmental fate, regulatory requirements, and related areas. HSDB is peer-reviewed by the SRP, a committee of experts in the major subject areas within the data bank's scope. For more information visit the HSDB Fact Sheet.


    EPA Announces New IRIS Assessment Development Process
    Submitted on May 21, 2009

    U.S. Environmental Protection Agency (EPA)

    Contact: LaTisha Petteway, (202) 564-3191 ext. 4355

    (Washington, D.C.)

    U.S. EPA Administrator Lisa P. Jackson today announced reforms to the agency's Integrated Risk Information System (IRIS) that will revitalize the program and ensure its scientific quality, integrity, transparency and timeliness.

    The IRIS database provides crucial information on ways human health is impacted by exposure to chemical substances in air, water, and land both from contaminated sites and from products. Combined with specific exposure information, government and private entities use IRIS to help characterize public health risks of chemical substances in a site-specific situation and thereby support risk management decisions designed to protect public health.

    "We're improving efficiency, scientific integrity, and transparency in a program that plays a vital role in our mission to protect human health and the environment," said EPA Administrator Lisa P. Jackson. "A more effective IRIS program gives EPA and the American people better information—and better information leads to safer, healthier communities."

    Other highlights of the new IRIS development process include a streamlined review schedule, ensuring that the majority of assessments are posted on IRIS within two years of the start date. This will result in more human health assessments being available to EPA's programs and regions and to other users of the IRIS database. The new process will no longer provide other federal agencies the opportunity to request suspension of an assessment process to conduct research on "mission critical" chemicals.

    While opportunities remain for input from other federal agencies and White House offices, the input will be from health scientists and will focus on scientific and technical comments. Further, all written comments from other federal agencies and White House offices will be made public, which will greatly improve the transparency of the process.

    EPA plays a critical role in disseminating timely, high quality, and accessible human health risk information on environmental contaminants that may endanger the health of the American public. IRIS is also a critical resource for risk assessors and environmental and health professionals in state and local governments and other countries.

    For far too long the success of EPA's IRIS program has been hampered by an assessment development process that took too long, was redundant, and was not transparent to the public. The new IRIS process will be entirely managed by EPA. EPA will have final authority over the contents of all IRIS assessments after considering the scientific input of experts at other agencies and White House offices. The well established processes of rigorous independent external peer review and public review and comment will remain key components of the new IRIS process.

    More information on IRIS.


    Press Release: Countries Unite to Reduce Animal Use in Produce Toxicity Testing Worldwide
    Submitted on Apr 27, 2009

    U.S., Canada, Japan and European Union Sign International Agreement

    Since You Asked—Alternatives to Animal Testing

    Representatives from four international agencies, including the director of the U.S. National Toxicology Program (NTP), today signed a memorandum of cooperation that could reduce the number of animals required for consumer product safety testing worldwide. The agreement between the United States, Canada, Japan and the European Union will yield globally coordinated scientific recommendations on alternative toxicity testing methods that should speed their adoption in each of these countries, thus reducing the number of animals needed for product safety testing.

    "Signing this international agreement demonstrates our commitment to finding and advancing alternatives to animal testing," said Linda Birnbaum, Ph.D., director of the NTP and National Institute of Environmental Health Sciences, part of the National Institutes of Health. "This agreement will help us achieve greater efficiency by avoiding duplication of effort and allowing us to leverage limited resources."

    Birnbaum signed as the U.S. representative on behalf of the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), one of the national validation organizations participating in the agreement. Others who signed include Elke Anklam, Ph.D., for the European Centre for the Validation of Alternative Methods (ECVAM), David Blakey, D.Phil., for the Environmental Health Science and Research Bureau within Health Canada, and Masahiro Nishijima, Ph.D. for the Japanese Centre for the Validation of Alternative Methods (JaCVAM).

    The agreement promotes enhanced international cooperation and coordination on the scientific validation of non- and reduced-animal toxicity testing methods. If the toxicity testing methods are shown to be reproducible based on strong scientific information, and able to accurately identify product related health hazards, the tests are more readily accepted by regulatory agencies.

    "The memorandum covers three critical areas of test method evaluation: validation studies, independent scientific peer review meetings and reports, and development of test method recommendations for regulatory consideration," said Marilyn Wind, Ph.D., chair of the Interagency Coordinating Committee on the Validation of Alternative Methods and a scientist at the Consumer Product Safety Commission (CPSC).

    "This international cooperation will benefit both people and animals," said William Stokes, D.V.M., director of NICEATM and executive director of ICCVAM. Stokes is also an assistant surgeon general in the U.S. Public Health Service. "The cooperation will serve an important role in translating research advances into more effective public health prevention tools. It will speed the adoption of new test methods based on advances in science and technology that will provide more accurate predictions of safety or hazard. Animal welfare will also be improved by the national and international acceptance of alternative test methods that reduce, refine, and replace the use of animals."

    Federal agencies are committed to the welfare of animals used in research. All animals used in federally-funded research are protected by laws, regulations and policies to ensure they are used in the smallest number possible and with the greatest commitment to their comfort. ICCVAM is working to promote the development and validation of alternative test methods. Alternative test methods are those that accomplish one or more of the 3Rs—reducing the number of animals used in testing, or refining procedures so animals experience less pain and distress, or replacing animals with non-animal systems.

    "We are very pleased to be part of this effort and to continue our already successful collaboration in a formalized manner," said Elke Anklam, Ph.D., director for the Institute of Health and Consumer Protection of the European Commission's Joint Research Centre, where the European Centre for the Validation of Alternative Methods, ICCVAM’s European counterpart, is located. Anklam has signed the agreement as representative on behalf of the EU. Her colleague Joachim Kreysa, Ph.D., the recently appointed head of ECVAM, further remarked, "I am enthusiastic about the agreement. Our collaboration will help to identify and embrace scientifically sound and robust new testing approaches, ensuring that safety assessments are never compromised, while at the same time reduce the need for animal testing."

    "Although we’ve had informal collaborations over the years, this more formal agreement will allow us to work more efficiently and effectively," said Hajime Kojima, Ph.D., director of the Japanese Centre for the Validation of Alternative Methods.

    David Blakey, D.Phil., director of the Environmental Health Science and Research Bureau within Health Canada, added that the effort is a major step forward. "Increased coordination, collaboration and communication will clearly enhance the global progress in this important area."

    The European Centre for the Validation of Alternative Methods coordinates validation studies on proposed alternative methods, evaluates the results by peer review, and provides recommendations to the European Union National Coordinators for regulatory acceptance of the methods validated. For more information on ECVAM, visit ECVAM Web site.

    The Japanese Centre for the Validation of Alternative Methods is a component of Japan’s National Institute of Health Sciences and was established in 2005 to coordinate validation studies on proposed alternative methods, conduct peer reviews of test methods, and provide recommendations to regulatory authorities.

    The Environmental Health Science and Research Bureau within Health Canada coordinates activities relevant to health-related test method validation and acceptance issues. For additional information, visit the Web site.

    The National Toxicology Program (NTP) is an interagency program established in 1978. The program was created as a cooperative effort to coordinate toxicology testing programs within the federal government, strengthen the science base in toxicology, develop and validate improved testing methods, and provide information about potentially toxic chemicals to health, regulatory, and research agencies, scientific and medical communities, and the public. The NTP is headquartered at the National Institute of Environmental Health Sciences (NIEHS). For additional information, visit NTP Web site.

    The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) administers and provides scientific support for ICCVAM and is a part of the NTP at the NIEHS. For additional information, visit the NICEATM Web site.

    NIEHS supports research to understand the effects of the environment on human health and is part of the National Institutes of Health (NIH). For more information on environmental health topics, visit the NIEHS Web site.

    The National Institutes of Health—The Nation's Medical Research Agency—includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit the NIH Web site.



    National Children's Study Begins Recruiting Volunteers
    Submitted on Apr 27, 2009

    U.S. DHHS, National Institutes of Health NIH News, Eurnice Kennedy Shriver National Institute of Child Health and Human Development

    (NICHD)

    For Immediate Release: Friday, April 24, 2009

    CONTACTS: Robert Bock or Marianne Glass Miller, (301) 496-5133

    The National Children's Study, the federal government's comprehensive study of how genes and the environment interact to affect children's health, has activated five additional centers to begin recruiting prospective volunteers in five new communities. These Vanguard Centers join two centers activated previously to recruit volunteers for the feasibility phase of the study, in which the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) will review the size, scope, and cost projections for the full study. The data gleaned from the feasibility phase will be used to inform the final research design.

    A total of seven Vanguard Centers were designated to conduct the feasibility phase of the study. Activation (initiation of patient recruitment) took place in two stages. Two centers were activated in January, and the remaining centers were activated this April.

    The National Children's Study is the federal government's comprehensive study of how genes and the environment interact to affect children's health. The study plans to track the health and development of as many as 100,000 children from before birth to adulthood. The study will enroll pregnant women in order to identify early life factors that influence later development. Researchers anticipate that the study will provide information that can be used in the prevention and treatment of a variety of conditions, such as preterm birth, asthma, diabetes, heart disease, and obesity.

    The study was authorized in the Children's Health Act of 2000. Government agencies leading the consortium carrying out the study are the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute of Environmental Health Sciences of the National Institutes of Health; the Centers for Disease Control and Prevention, and the U.S. Environmental Protection Agency.

    The study locations are counties or clusters of counties chosen by National Children's Study researchers to be representative of children in the United States.

    The Centers now beginning recruitment and their corresponding locations are:
    • Children's Hospital of Philadelphia, serving Montgomery County, Pa.
    • South Dakota State University, serving Brookings County, S.D. and Lincoln, Pipestone, and Yellow Medicine counties, MN.
    • University of California, Irvine, serving Orange County, CA.
    • University of Utah serving Salt Lake County, UT.
    • University of Wisconsin, Madison and Medical College of Wisconsin, serving Waukesha County, WI.
    The first Vanguard Centers, at the University of North Carolina at Chapel Hill and the Mount Sinai School of Medicine in New York, began recruiting volunteers in January. A news release on the launch of the National Children's Study appears at the NIH News Web site.

    During the Vanguard pilot phase, study researchers will evaluate the recruitment and sampling methods, as well as all other methods of the study. At the end of this phase, study scientists will review the pilot experience—including scope and costs—and make any necessary adjustments to the Study before a decision is made on expanding recruitment to more sites.

    As part of their recruitment activities, the Vanguard Centers will hold presentations and other community awareness activities in their respective locations to inform prospective volunteers. Prenatal care providers and clinics in the study locations will also inform their patients about the study.

    The NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit the Institute's Web site.

    The National Institutes of Health (NIH)—The Nation's Medical Research Agency—includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit the NIH Web site.


    NICEATM Announces Peer Review Panel Meeting on the Murine Local Lymph Node Assay; Availability of Draft Documents
    Submitted on Apr 21, 2009

    National Toxicology Program

    The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), will convene an independent scientific peer review panel (Panel) meeting to evaluate updated information on three non-radioactive versions and an expanded applicability domain for the Murine Local Lymph Node Assay (LLNA). The Panel meeting will take place April 28–29, 2009, at the Natcher Conference Center, National Institutes of Health, Bethesda, MD, and is open to the public at no charge.

    NICEATM invites public comments on draft ICCVAM test recommendations and draft Background Review Documents (BRD) that will be considered by the Panel. The documents will soon be available on the NICEATM-ICCVAM Web site.

    NICEATM and ICCVAM convened the peer review panel In March 2008 to review the new versions and applications of the LLNA. However, the Panel concluded that more information and data were required for the revised test methods and the proposed expanded applicability domain before recommendations could be made regarding their use for regulatory safety testing. NICEATM has received additional information and revised the BRDs. ICCVAM has also revised its draft test method recommendations regarding proposed usefulness and limitations, standardized protocol, and future studies. The Panel will consider the additional information and revised recommendations.

    The LLNA is a test method that can be used to determine the allergic contact dermatitis potential of chemicals and products for regulatory hazard classification and labeling purposes. As an accepted alternative to traditional guinea pig tests, it uses fewer animals and eliminates pain and distress. ICCVAM is evaluating the new versions and applications of the LLNA in response to a request from the U.S. Consumer Product Safety Commission. The new versions and applications, if recommended by ICCVAM and accepted by regulatory agencies, could expand the range of substances and products that can be tested in the LLNA. The new versions could also be used more widely because they do not require the use of radioactive markers.

    View The draft ICCVAM test method recommendations and draft background review documents.



    EPA To Begin Testing Pesticides for Endocrine Disruption
    Submitted on Apr 15, 2009

    U.S. Environmental Protection Agency (EPA)

    Contact (news media): Suzanne Ackerman, (202) 564-4355 Ext. 7819

    Other inquiries: Linda Phillips, (202) 564-1264

    (Washington, D.C.—April 15, 2009) EPA has issued the first list of pesticides to be screened for possibly disrupting the endocrine system. Endocrine disruptors are chemicals that interact with and possibly disrupt the hormones produced or secreted by the human or animal endocrine system, which regulates growth, metabolism and reproduction.

    “Endocrine disruptors can cause lifelong health problems—especially for children,” said EPA Administrator Lisa P. Jackson. “Gathering this information will help us work with communities and industry to protect Americans from harmful exposure.”

    EPA will issue test orders to the manufacturers of 67 pesticide chemicals this summer to determine whether their chemicals may disrupt the endocrine systems (estrogen, androgen and thyroid). Testing, conducted through the Endocrine Disruptor Screening Program (EDSP), will eventually be expanded to cover all pesticide chemicals.

    The list was developed on the basis of exposure potential and should not be construed as a list of known or likely endocrine disruptors. The listed pesticide chemicals were selected because there is high potential for human exposure through food and water, residential activity, or agricultural pesticide application.

    Also being announced today are revised policies and procedures that EPA will follow to order testing, minimize duplicative testing, promote equitable cost-sharing, and protect manufacturers’ confidential business information.

    More information on endocrine disruptors see the EPA Web site.



    Study Finds Environmental Education Programs Lead to Cleaner Air
    Submitted on Apr 13, 2009

    U.S. Environmental Protection Agency (EPA)

    Study Finds Environmental Education Programs Lead to Cleaner Air National Environmental Education Week: April 12–18—Contact: Enesta Jones, (202) 564-7873 Ext. 4355, (Washington, D.C.—April 13, 2009) A first of its kind study funded by EPA shows that environmental education programs are an effective tool in helping to improve air quality in North America.

    "This study shows a valuable connection between better environmental education and cleaner air in our communities," said EPA Administrator Lisa P. Jackson. "With the right information, people can make a real difference in the places where they live, work, play and learn."

    Nearly half of the surveyed institutions hosting education programs reported an improvement in air quality at their facilities due to actions taken by students, including doing service-learning projects and fostering community partnerships. Examples include decreased levels of carbon monoxide and mold, and enactment of a policy that decreased car or bus idling. An additional 43 percent of the surveyed programs reported some kind of action was taken to improve the environment.

    Some examples include:
    • East Valley Middle School (Wash.) where students monitored school indoor air quality and worked with school administrators to implement structural changes resulting in improved carbon dioxide, air flow, particulate levels, odors and mold.
    • Exeter High School (N.H.) where students studied air quality issues and monitored car pooling and bus idling in the school drop-off area, leading to a no-idling policy and installation of no-idling signs.
    • Greater Egleston Community High (Mass.) where student actions helped lead to the installation of a local air quality monitoring station, a change in fuels by city buses, and city-wide bus idling restrictions.
    EPA worked with the National Park Service Conservation Study Institute, Shelburne Farms, and a group of environmental researchers, educators and psychologists to complete the study.

    Information on the study visit the EPA Web site.


    NCRR Competitive Revision Application Information Now Available
    Submitted on Apr 01, 2009

    Application Due Date: April 21, 2009 or July 10, 2009

    The National Center for Research Resources, part of the National Institutes of Health, announced today that investigators and U.S. institutions or organizations with active NIH-funded R01 awards originally reviewed by the Center for Scientific Review may submit revision applications (formerly termed competitive supplements). These revision applications are intended to leverage the resources, expertise and infrastructure of NCRR centers and center-like programs through significant expansion of the scope or research protocol of approved and funded projects. For other investigator-initiated grants (R33, R37, R21, U01), please contact your funding institute or center.

    Support for these revision applications will come from funds provided to NIH through the American Recovery and Reinvestment Act of 2009 (Recovery Act). Consistent with the intent of the Recovery Act, the purpose of the program is to promote job creation and economic development along with accelerating the pace and achievement of scientific research.

    To learn more, visit the NCRR ARRA site.



    NIH Announces American Recovery and Reinvestment Act Funding Opportunities
    Submitted on Mar 12, 2009

    $1 Billion Available for Extramural Core Facilities and Other Construction, Renovation or Repair Awards

    The National Institutes of Health announced today some of the new funding opportunities made possible through the American Recovery and Reinvestment Act (ARRA). One billion dollars of the $10.4 billion provided to NIH under ARRA has been allocated for federal awards to institutions seeking to construct, renovate or repair biomedical or behavioral research facilities. The National Center for Research Resources, a part of NIH, will administer these categories of grants.

    Signed into law by President Obama on Feb. 17, 2009, ARRA provides funds intended to stimulate the economy. Consistent with this legislative purpose, NIH is pleased to use ARRA-supported funding opportunities to help create or maintain American jobs, while advancing research.

    "We are pleased to launch one of our agency’s first efforts through grants that have exceptional potential to create new jobs and improve the economy while leading the way toward important medical discoveries that can benefit the health of Americans nationwide," said NIH Acting Director Raynard S. Kington, M.D., Ph.D. "NIH is well-positioned to fund the best science in pursuit of improving the length and the quality of the lives of American citizens, while at the same time stimulating the economy."

    Institutions must apply for these ARRA funds under NIH’s grant application process, in which applications undergo review by experts. Funding will be awarded using two categories of facility construction and improvement grants.

    Core Facility Renovation, Repair and Improvement. This funding opportunity is designed to upgrade extramural core facilities to support biomedical and/or behavioral research, funded by the U.S. Public Health Service (PHS). Extramural research is conducted off the NIH campus, nationwide, by NIH-funded institutions and organizations. A core facility is defined as a centralized shared resource that provides access to instruments or technologies or services, as well as expert consultation to NIH-funded investigators. The deadline for applications is Sept. 17, 2009. Budgets between $1 million and $10 million may be requested. For more information, visit NIH Web site.

    Extramural Research Facilities Improvement Program. This funding opportunity is designed to construct, renovate or repair biomedical or behavioral research extramural facilities. The major objective is to facilitate and enhance the conduct of PHS biomedical and behavioral research by providing the costs of improving non-federal basic research and clinical research to meet the research, research training or research support needs of an institution. Deadlines are May 6, June 17 and July 17, 2009, depending upon the funding amount requested. Amounts can range from $2 million to $15 million. For more information about applying, see NIH Web site.

    To demonstrate accountability to the American people, institutions that are awarded ARRA funds will be required to submit special progress reports indicating how many jobs were created as a result of the funding. Additionally, recipients of ARRA-supported awards must assess the environmental impact of their facilities; accordingly "green" design approaches and technologies should be considered. Other reporting requirements may also be imposed. ARRA requires an expedited obligation of awards.

    NIH conducts and supports outstanding biomedical and behavioral research, through more than 3,000 institutions across the country—institutions that have a direct impact upon the local economies in their towns, cities and states.

    More information about ARRA/NIH/NCRR grants can be found at www.ncrr.nih.gov/recovery. All ARRA/NIH grants can be found at NIH Web site.

    The National Center for Research Resources, a part of NIH, provides laboratory scientists and clinical researchers with the resources and training they need to understand, detect, treat and prevent a wide range of diseases. NCRR supports all aspects of translational and clinical research, connecting researchers, patients and communities across the nation. For more information, visit www.ncrr.nih.gov.

    The National Institutes of Health (NIH)—The Nation's Medical Research Agency—includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

    The activities described in this release are being funded through the American Recovery and Reinvestment Act (ARRA). To track the progress of HHS activities funded through the ARRA, visit www.hhs.gov/recovery. To track all federal funds provided through the ARRA, visit www.recovery.gov.



    ToxProfilesTM Offers Latest Information on Hazardous Substances and Chemicals
    Submitted on Mar 11, 2009

    Agency for Toxic Substances and Disease Registry

    ATLANTA—The updated edition of ToxProfiles™, a two-CD ROM set featuring updated information on more than 180 chemicals and hazardous substances as well as an improved search engine, is now available from the Agency for Toxic Substances and Disease Registry (ATSDR). ATSDR’s ToxProfiles™, are a useful resource for health professionals, researchers, students, media and others interested in the health effects of exposure to specific chemicals and hazardous substances.

    This newest edition of the ToxProfiles™ includes 11 updated profiles including those for chromium, cadmium, manganese, and radon. The new ToxProfiles™ CDs feature:

    • 166 Toxicological Profiles. The profiles offer an in-depth, peer-reviewed analysis and review of the most current information available on the toxicological and adverse health effects of exposure to hazardous substances and chemicals.
    • 167 Public Health Statements. Public Health Statements are taken from the first chapters of their respective toxicological profiles and are written in plain language. Also available in Spanish.
    • 184 ToxFAQs. ToxFAQs are easy-to-understand, two-page fact sheets on specific chemical substances. These are written to provide quick answers to the most frequently asked questions about how someone may be exposed to the chemical and the personal health risks of the exposure. Also available in Spanish.

    ToxProfiles™ also include Interaction Profiles which provide available data on the toxicology of chemical mixtures and the joint toxic action of chemicals in a mixture. This information is used by toxicologists and other health professionals to recommend specific approaches to assess potential public health hazards.

    ToxProfiles™ can be ordered from the Centers for Disease Control and Prevention by calling 1-800-CDC INFO (800-232-4636) or via e-mail at: cdcinfo@cdc.gov. There is no charge for this product. These products are also available on-line at www.atsdr.cdc.gov/toxpro2.html.

    ATSDR, a federal public health agency of the U.S. Department of Health and Human Services, evaluates the human health effects of exposure to hazardous substances.



    Joint FAO/WHO Expert Meeting on the Application of Nanotechnologies in the Food and Agriculture Sectors—Call for Expert Deadline January 16, 2009
    Submitted on Dec 23, 2008

    The Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) have recognized a need for scientific advice on any food safety implications that may arise from the use of nanotechnologies in the food and agriculture sectors through its horizon scanning activities. FAO and WHO are planning the Joint Expert Meeting to take stock of existing and emerging applications of nanotechnologies in the food and agriculture sectors. The meeting will be held June 1–5, 2009 at FAO Headquarters in Rome, Italy.

    Research and development on nanoscale-science has been growing worldwide. Investment of both the public and private sector is expanding rapidly in applications of nanotechnologies to various areas. Government authorities in several countries have established funding and coordinating mechanisms to support their national nanotechnology research programmes. There are still relatively few applications of nanotechnologies that have been commercialized but the potential is well recognized.

    In areas of agriculture and food production, a number of applications of nanotechnologies are emerging with the capacity to impact both the food industry and consumers (e.g. food processing and packaging, production of agrochemicals and seed).

    Like other new or modern technologies, nanotechnology has the potential to bring significant benefits, but may also introduce potential risks for human health and the environment. Nano-materials may cause health risks which are different from those of similar materials in micro or macro form. There is a need for research to obtain more data on dietary exposure to such materials as well as on their toxicological and physiological effects.

    Given the increased global interest in the use of nanotechnology and concerns on the potential food safety implications, FAO and WHO have planned to convene a joint Expert Meeting which aims to identify knowledge gaps including issues on food safety, review current risk assessment procedures, consequently support further food safety research and develop global guidance on adequate and accurate methodologies to assess potential food safety risks that may arise from nanoparticles.

    The call for experts and call for information have now been posted on the FAO Web site and on the WHO Web site.



    Link Possible Between Pet Food Contamination and Baby Formula Contamination
    Submitted on Nov 03, 2008

    Reston, VA (October 28, 2008)—A study(1) published in the November issue of a scientific journal, Toxicological Sciences, which is published by Oxford Journals on behalf of the Society of Toxicology, describes the kidney toxicity of melamine and cyanuric acid based on research that was done to characterize the toxicity of the compounds that contaminated pet food in North America in 2007. This research points to a possible link between the pet food contamination that occurred in North America in 2007 and the recent adulteration of milk protein and resultant intoxication of thousands of babies from Asia.

    The research described in the paper identifies the principal contaminants as melamine and cyanuric acid. Neither of these compounds is very toxic when administered alone; however, when given in combination, the two compounds form a virtually insoluble complex. This complex forms in the tubules of the kidney, blocking urine flow and causing renal failure. The research in the paper was done in rats, but because the toxicity depends only on the two compounds being present in the kidney at the same time, is relevant to other species, including humans. The research presented in the paper also shows that the melamine-cyanuric acid complex is soluble in acid, suggesting that acidification of the urine in the distal tubules of the kidney may be a reasonable treatment option. The paper is posted at ToxSci Oxford Journals. The article is being made freely available as a public service so that physicians and the interested public will have complete access to this information.

    Notes:
    [1] Identification and Characterization of Toxicity of Contaminants in Pet Food Leading to an Outbreak of Renal Toxicity in Cats and Dogs, 106, no.1 (November 2008): 251-262, Roy L. M. Dobson*, Safa Motlagh*, Mike Quijano*, R. Thomas Cambron*, Timothy R. Baker*, Aletha M. Pullen*, Brian T. Regg*, Adrienne S. Bigalow-Kern*, Thomas Vennard*, Andrew Fix*, Renate Reimschuessel , Gary Overmann*, Yuching Shan* and George P. Daston*,1

    The official journal of the Society of Toxicology, Toxicological Sciences publishes premier peer-reviewed, hypothesis-driven, original research articles in all areas of toxicology. Please acknowledge the journal as a source in any articles.

    Contact: (media enquiries only)

    Martha Lindauer
    Communications/Media Manager
    Society of Toxicology
    (703) 438-3115 ext. 1640

    Or

    Kirsty Luff
    Senior Communications and Marketing Manager
    Oxford Journals, Oxford University Press
    +44-1-865-354206



    Toxicity Testing in the 21st Century: A Vision and A Strategy
    Submitted on Sep 17, 2008

    SOT President Kenneth S. Ramos talks about a 2007 report that was released by the National Research Council entitled, "Toxicity Testing in the 21st Century: A Vision and A Strategy" and how data using genomics and computational methodologies in the future will make it possible for scientists to predict pathways of toxicity that reflect mechanisms or modes of toxicity. According to Ramos, the recommendations presented in the report suggest that because of the differences between human and animal biology, the nature of a particular risk resonse may result in the need for scientists to find better ways to define human risk to drugs and animals. Many SOT members were on the panel producing the report including: Daniel Acosta, Jr., Melvin Andersen, Henry Anderson, Kim Boekelheide, Gail Charnley, Sidney Green, Nancy Kerkvliet, Abby Li, D. Reid Patterson, Robert Scala, Martin Stephens, James Yager, and Lauren Zeise. The report was featured in a SOT 2008 Annual Meeting session and will also be a topic at the 2009 SOT Annual Meeting session. Read more on the report.


    NIEHS—Newly Approved Ocular Safety Methods Reduce Animal Testing
    Submitted on Jul 09, 2008

    Federal regulatory agencies have accepted recommendations of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) for two methods that can reduce live animal use for ocular safety testing, the committee announced today. ICCVAM is a permanent interagency committee composed of representatives from 15 federal regulatory and research agencies, including the National Institutes of Health (NIH) that use, generate or disseminate toxicology testing information. More on Approved Ocular Safety Methods.


    Opportunities Abound in Toxicology
    Submitted on Jul 02, 2008

    Tox Opportunities Abound—The June 20th issue of Science: Science Careers offers a fresh look at toxicology careers, training and the future of toxicology through the eyes of one undergraduate student who had a degree in biochemistry and then entered the toxicology Ph.D. program at the University of Washington in Seattle. Science explores the workforce shortage, salaries, training, and career paths in this dynamic field. Read more on Opportunities Abound in Toxicology


    Report on Enhancing Peer Review at NIH Implementation Plan
    Submitted on Jun 09, 2008

    Lawrence A. Tabak, D.D.S., Ph.D.

    National Institutes of Health (NIH) Director Elias A. Zerhouni, M.D., announced today at the 96th Meeting of the Advisory Committee to the Director (ACD) critical changes to enhance and improve the NIH peer review system.

    View the related press release: NIH News

    More details on these changes are described in the PowerPoint presentation given at today’s meeting.

    More information on the Enhancing NIH Peer Review initiative is available on-line.



    FDA Appoints Dr. Frank M. Torti as Principal Deputy Commissioner and New Chief Scientist
    Submitted on Apr 09, 2008

    Dear Constituent,

    Today, Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. announced the appointment of Frank M. Torti, M.D., M.P.H., as the FDA’s Principal Deputy Commissioner and first Chief Scientist. The newly-created Chief Scientist position stems from the Food and Drug Administration Amendments Act of 2007 (see the FDA Web site).

    A prominent clinician, scientist and researcher in molecular oncology, Dr. Torti is currently serving as Charles L. Spurr Professor of Medicine, Chair of the Department of Cancer Biology, and Director of the Comprehensive Cancer Center at Wake Forest University School of Medicine in Winston-Salem, N.C. Throughout his career, Dr. Torti has served on and chaired a number of national health and medical committees. He currently serves on the National Institutes of Health’s National Advisory Council for Complementary and Alternative Medicine. He also founded and serves as President of the Cancer Biology Training Consortium, a national society of cancer biology department chairs and program directors. He is the recipient of a National Institutes of Health MERIT Award. More detailed information about Dr. Torti’s accomplishments is available on the FDA Web site.

    Dr. Torti will join FDA in May.

    Sincerely yours,

    Ken Nolan Senior Program Specialist Office of External Relations U.S. Food and Drug Administration


    NIH-CSR and NIEHS Announce the Creation of a New Special Emphasis Panel Dedicated to the Review of Toxicology Grant Applications
    Submitted on Mar 27, 2008

    A February 20, 2008 letter to SOT from NIH Center for Scientific Review (CSR) Director Dr. Antonio Scarpa and National Institute of Environmental Health Sciences Acting Director Dr. Samuel Wilson announced the creation of a new Systemic Injury by Environmental Exposure (SIEE) Special Emphasis Panel (SEP). SIEE has been created as a temporary standing SEP and is a pilot program. SIEE reviews will begin with applications submitted in June 2008 and will continue for three review cycles into 2009, after which the performance of the SEP will be critically reviewed.

    In 2002, the CSR completed an NIH-wide restructuring of Integrated Review Groups and Study Sections, based on the scientific boundaries report, to make the review system more organ- and disease-centered. This produced many enhancements, but also resulted in the elimination of 2 of 3 study sections that focused on toxicology research questions. What followed was the dispersal of toxicology-focused applications over a large number of diverse panels, and often poorer review outcomes. For the past five plus years, SOT has engaged in discussions with NIH leadership to resolve this issue. While SOT representatives continued working with CSR leadership, SOT members attended all six NIH-CSR Open House Workshops between March and December 2007. Input from both SOT lea dership and members was relayed to CSR and played an important role in the response of CSR to this issue with the creation of the new SIEE SEP.

    The CSR has emphasized that the SIEE SEP is a pilot, and that there is no guarantee or expectation that SIEE will transition into a permanent Study Section. As noted in the Special Issue of the Communique, "For SIEE to be viable for conversion to a standing Study Section, it is imperative for toxicologists to request that their qualifying grants be assigned to this SEP" and for toxicologists to volunteer to serve on the panel. Small numbers of reviewed grant applications and poor review performance would pose significant barriers to success. Even with a successful SIEE SEP, much more remains to be done to strengthen the review process by increasing the clustering of toxicology grant applications.

    The SIEE SEP will review applications related to the pharmacological and toxicological mechanisms whereby xenobiotics (including toxicants, alcohol, drugs, biopharmaceuticals, phytochemicals and other non-drug chemicals) affect distinct organ systems, other than the digestive and nervous systems, including cardiovascular, musculoskeletal, hematopoietic, renal, respiratory/pulmonary, immune, endocrine and reproductive systems. Other covered areas are skin, oral, dental and craniofacial tissues, pregnancy and development. Applications addressing the effects of xenobiotics at the multi-organ level may also be considered.

    Click Here to visit the CSR web site and learn more, including the role of the SIEE SEP within the Digestive Sciences Integrative Review Group. SOT Announces a Late-Breaking CSR Session on "Challenges and Opportunities in the NIH Peer Review. A Vision for Ensuring its National Strategic Value" at the 2008 Annual Meeting in Seattle Dr. Antonio Scarpa will be a featured speaker at our Seattle meeting (Wednesday, March 19, 1:30–2:30 PM in Room 3A). This late-breaking session will be of considerable relevance to SOT Members seeking NIH funding. Dr. Scarpa will describe broad Challenges and Opportunities in the NIH Peer Review. A Vision for Ensuring its National Strategic Value. He will describe the new Systemic Injury by Environmental Exposure (SIEE) Special Emphasis Panel (SEP) under the existing Digestive Sciences Integrative Review Group (IRG). The SIEE SEP will provide for the review of a broad range of grant proposals related to systemic injury due to environmental factors. The session will also offer an opportunity for questions and answers. Sincerely, SOT Presidential Chain George B. Corcoran, President Kenneth S. Ramos, Vice President Cheryl L. Walker, Vice President-Elect James A. Popp, Past President Creating a Safer and Healthier World by Advancing the Science of Toxicology


    Draft Peer Review Report
    Submitted on Mar 03, 2008

    On February 28, 2008, the Final Draft of the NIH 2007–2008 Peer Review Self-Study was submitted to Dr. Elias Zerhouni, Director of NIH, marking the end of the diagnostic phase of the peer review enhancement effort.

    To obtain the PDF file of Final Draft Report: Final Draft Report (PDF, 1.69MB)—please go to the Peer Review Website

    This Final Draft Report identifies the most significant challenges facing the NIH peer review system and proposes recommended actions. If you wish to comment on the Final Draft, please send your comments no later than Monday, March 17, 2008, via:

    Electronically: PeerReviewRFI@mail.nih.gov



    EPA/NIH Press Release
    Submitted on Mar 03, 2008

    NIH Collaborates with EPA to Improve the Safety Testing of Chemicals

    New Strategy Aims to Reduce Reliance on Animal Testing

    Testing the safety of chemicals ranging from pesticides to household cleaners will benefit from new technologies and a plan for collaboration, according to federal scientists from the National Institutes of Health (NIH) and the U.S. Environmental Protection Agency (EPA), who today announced a new toxicity testing agreement. The concept behind this agreement is highlighted in the Feb. 15, 2008 issue of the journal Science. Read More...


    NIH CSR Creates Toxicology SEP
    Submitted on Feb 26, 2008

    Dear George:

    As part of an effort to enhance peer review, the Center for Scientific Review (CSR) in cooperation with the National Institute of Environmental Health Sciences (NIEHS) will start a pilot in which a Special Emphasis Panel (SEP) will review applications on systemic injury

    As this is a year when NIH Director Dr. Elias Zerhouni is focusing on enhancing peer review, other aspects of peer review are likely to be piloted that will eventually affect review of all applications, including those in which you and others in the Society of Toxicology have interest. We may have a better sense of those possibilities in a few weeks. Also, on a lesser scale, CSR is conducting a systematic study of so-called orphan applications, those which number less than five per study section per cycle. This will require a significant amount of time; however, the outcome of this systematic study is likely to be precedent setting.

    If you would seek clarification about any of these developments please let us know.

    Sincerely,
    Toni Scarpa, Director CSR
    Samuel Wilson, Acting Director NIEHS


    Nearly 7,000 Toxicologists Expected to Attend SOT Annual Meeting in Seattle
    Submitted on Feb 20, 2008

    Society of Toxicology Press Release

    The Society of Toxicology’s Annual Meeting and ToxExpo will bring together thousands of researchers and regulators from universities, government and industry. Throughout the week, workshops and poster sessions will provide up-to-the-minute research and analysis on subjects connected with disease, human and animal health, occupational safety and many related issues. View Press Release


    Study Suggests High Temperature Boosts Leaching from Plastic Bottles
    Submitted on Feb 20, 2008

    We're all concerned about the impact that plastic bottles have on the environment. Now a new study suggests that plastic bottles may represent a health risk. http://www.saultstar.com/ArticleDisplay.aspx?e=905930


    Take a Walk Though a Morgue
    Submitted on Feb 20, 2008

    Have you ever wondered what role toxicology plays in real life criminal investigations like those shown on “Law & Order” and “CSI”? Let’s take a walk through the morgue at the Regina Media Center in Albert Lea, Minn. http://www.albertleatribune.com/articles/2008/02/16/news/news5.txt


    U.S. Agencies Vow to End Animal Testing
    Submitted on Feb 20, 2008

    Three U.S. government agencies have signed an agreement to put an end to testing new drugs and chemicals on animals. Does this signal an end to animal testing? http://www.dbtechno.com/science/2008/02/15/agencies-in-us-vow-to-end-animal-testing/


    Does U.S. Spy Satellite Fuel Pose a Danger?
    Submitted on Feb 20, 2008

    The U.S. has announced recently that it plans to shoot down one of its spy satellites, which is loaded with a toxic fuel called hydrazine. How dangerous is hydrazine? The Wall Street Journal asked Kenneth Ramos, Vice President of the Society of Toxicology. http://blogs.wsj.com/health/2008/02/15/hydrazine-the-toxic-fuel-in-that-busted-spy-satellite/ ?mod=googlenews_wsj


    Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment
    Submitted on Oct 11, 2007

    National Academies of Sciences National Research Council

    A new report issued by the National Academies of Sciences National Research Council entitled "Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment" states that the technological hurdles that could have limited the reproducibility of data from toxicogenomic technologies have been resolved and recommends ways for the field to move forward. This report recognizes the importance of toxicogenomics in predicting effects on human health and recommends the integration of toxicogenomics into regulatory decision making. The NAS report was commissioned by the National Institute of Environmental Health Sciences (NIEHS) part of the National Institutes of Health (NIH) and a leader in the development of toxicogenomic technologies. Toxicogenomic technologies provide tools to better understand the mechanisms through which environmental agents initiate and advance disease processes. They can also provide important information to help identify individuals that are more susceptible to disease risks posed by certain environmental agents than the general population. "Using toxicogenomic technologies will open the door for public health decision makers who need to decide in a timely and accurate manner what chemicals are safe and which ones are not," says Christopher Portier, Ph.D., Associate Director, NIEHS and Director, Office of Risk Assessment Research. The full press report from NIEHS is found at http://www.niehs.nih.gov/news/releases/2007/nas.cfm. The National Academies of Sciences press report is found at http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12037.


    David Schwartz Steps Aside as Director of NIEHS/NTP
    Submitted on Aug 20, 2007

    Mary Gant, NIEHS/NTP

    Dear Colleagues:

    As you know, there have been recent inquiries by members of Congress and others regarding certain activities and management decisions at the National Institute on Environmental Health Sciences (NIEHS) and the National Toxicology Program (NTP). Dr. Zerhouni has responded to these inquiries and is taking appropriate action to ensure that the issues being raised are reviewed and, if necessary, properly addressed.

    Today, Dr. Zerhouni announced an initiative that commissions senior management experts to conduct a comprehensive review at NIEHS and NTP, focusing on the operations in the intramural, extramural and administrative arenas. This review, which will be concluded within several months, will address areas such as governance, internal controls and employee morale. In addition, this independent review will focus on personnel issues, contracts, grants, and financial management issues, as well as the administration of the ethics program.

    To ensure the independent nature of the review, while it is being conducted, I will temporarily step aside as Director of the NIEHS and NTP. During this period, I will serve as a senior advisor on environmental health sciences to Dr. Zerhouni and will continue to serve as Chief, Laboratory of Environmental Lung Disease, NHLBI. Dr. Zerhouni has requested that Dr. Samuel H. Wilson, serve as the Acting Director of NIEHS and the Acting Director of NTP during the review period. Dr. Wilson, who is internationally recognized for his work genetic toxicology, has served ably as the Deputy at NIEHS and NTP. He will consult regularly with Dr. Raynard Kington, Deputy Director of NIH, regarding management and operation decisions. I urge you to cooperate fully with Dr. Wilson and provide him with the same professional support and courtesy extended to me.

    Although this development is personally painful, I am committed to a full and comprehensive review of the management of NIEHS/NTP. I urge all of you to fully cooperate with the experts conducting the management review. I firmly believe this independent review will enable NIEHS/NTP to respond to the recent inquiries and ultimately provide strong direction for the future leadership and management of NIEHS and NTP. I am grateful to the staff of NIEHS and NTP who remain dedicated to the Institute's mission of improving public health and look forward to continuing our work together.

    David

    David Schwartz, MD
    Director, National Institute of Environmental Health Sciences and National Toxicology Program
    P.O. Box 12233, MD:B2-01
    Research Triangle Park, NC 27709-2233
    Phone: 919-541-3201
    Fax: 919-541-2260
    E-mail: david.schwartz@niehs.nih.gov



    In Memoriam: SOT Past President Emil Pfitzer
    Submitted on Aug 15, 2007

    Saratoga News and E-mails

    Emil Pfitzer It is with sadness that we report that SOT Past President Dr. Emil Pfitzer passed away on July 20th . He led the Society during its 25th anniversary year (1985-86) and was a member of the 40th Anniversary SOT Task Force. In addition, he was an Honorary Lifetime Member of the Society’s Mid-Atlantic Regional Chapter. Dr. Pfitzer was a graduate of the University of Chattanooga, and received an Sc.D in Industrial Hygiene from the University of Pittsburgh. Early in his career, he was on the faculty of the University of Pittsburgh and the University of Cincinnati. In 1972 he began 20 years of service at Hoffman-LaRoche, Inc., becoming the vice president of toxicology and pathology. Following his retirement in 1994, he became president of the Research Institute for Fragrance Materials. He also served as an adjunct professor at several colleges and as a consultant to numerous institutions. Dr. Pfitzer was a Fellow of the Academy of Toxicological Sciences and a Diplomate, American Board of Toxicology. He is survived by his three children and six grandchildren.


    FOHS Announces Its 2006 Worldwide Outreach Program Grant Recipients and Call for 2007 Applications—July 11, 2007
    Submitted on Jul 31, 2007

    The Foundation for Occupational Health and Safety (FOHS) is pleased to announce its Worldwide Outreach Program grant recipients for 2006. More Information



    Greenberg elected as President-Elect of the American Academy of Clinical Toxicology
    Submitted on Jul 05, 2007

    Michael I. Greenberg, MD,MPH, an SOT member, has been elected President-Elect of the American Academy of Clinical Toxicology(AACT). Dr. Greenberg will serve two years as President -Elect followed by two years as President followed by two years as Past President. AACT is the largest organization of clinical toxicolgists in the world. Visit the AACT Web site


    IPCC Adopts Major Assessment of Climate Change Science
    Submitted on Mar 21, 2007

    Paris, 2 February 2007 – Late last night, Working Group I of the Intergovernmental Panel on Climate Change (IPCC) adopted the Summary for Policymakers of the first volume of “Climate Change 2007”, also known as the Fourth Assessment Report (AR4). “Climate Change 2007: The Physical Science Basis”, assesses the current scientific knowledge of the natural and human drivers of climate change, observed changes in climate, the ability of science to attribute changes to different causes, and projections for future climate change. The report was produced by some 600 authors from 40 countries. Over 620 expert reviewers and a large number of government reviewers also participated. Representatives from 113 governments reviewed and revised the Summary line-by-line during the course of this week before adopting it and accepting the underlying report. The Summary can be downloaded in English from www.ipcc.ch and http://ipcc-wg1.ucar.edu and. A webcast of the final press conference has also been posted. The Summary will be available in Arabic, Chinese French, Russian and Spanish at a later date. The full underlying report will be published in English by Cambridge University Press.


    Mercury Contamination of Fish Warrants Worldwide Public Warning
    Submitted on Mar 21, 2007

    University of Wisconsin-Madison

    The health risks posed by mercury-contaminated fish is sufficient to warrant issuing a worldwide general warning to the public-especially children and women of childbearing age-to be careful about how much and which fish they eat. That is one of the key findings comprising "The Madison Declaration on Mercury Pollution" published today in a special issue of the international science journal Ambio. Developed at the Eighth International Conference on Mercury as a Global Pollutant last August in Madison, Wis., the declaration is a synopsis of the latest scientific knowledge about the danger posed by mercury pollution. It presents 33 principal findings from five synthesis papers prepared by the world's leading mercury scientists and published in the same issue of Ambio. The declaration and supporting papers summarize what is currently known about the sources and movement of mercury in the atmosphere, the socioeconomic and health effects of mercury pollution on human populations, and its effects on the world's fisheries and wildlife. Five other major findings in the declaration were: - On average, three times more mercury is falling from the sky today than before the Industrial Revolution 200 years ago as a result of the increasing use of mercury and industrial emissions. - The uncontrolled use of mercury in small-scale gold mining is contaminating thousands of sites around the world, posing long-term health risks to an estimated 50 million inhabitants of mining regions. These activities alone contribute more than 10 percent of the mercury in Earth's atmosphere attributable to human activities today. - Little is known about the behavior of mercury in marine ecosystems and methylmercury in marine fish, the ingestion of which is the primary way most people at all levels of society worldwide are exposed to this highly toxic form of mercury. - Methylmercury exposure now constitutes a public health problem in most regions of the world. - Methylmercury levels in fish-eating birds and mammals in some parts of the world are reaching toxic levels, which may lead to population declines in these species and possibly in fish populations as well. "The policy implications of these findings are clear," said James Wiener, a Wisconsin Distinguished Professor at the University of Wisconsin-La Crosse who served as technical chair for last summer's conference. "The declaration and detailed analyses presented in the five supporting papers clearly show that effective national and international policies are needed to combat this global problem." Published by the Royal Swedish Academy of Sciences, Ambio is widely recognized as an important international forum for debate on scientific, social, economic and cultural issues affecting the human environment. Wiener said the Madison Declaration summarizes a year-long effort by many of the world's leading mercury scientists, assembled into four expert panels, to review and synthesize the major mercury science findings. Every member of all four scientific panels endorsed the declaration, he said. Wiener added that all 1,150 participants at the conference were invited to express their confidence in the experts' findings, and the vast majority of those who did so agreed with the experts' conclusions. Other major findings in the declaration include: - Increased mercury emissions from developing countries over the last 30 years have offset decreased emissions from developed nations. - There is now solid scientific evidence of methylmercury's toxic health effects, particularly to the human fetus. - New evidence indicates that methylmercury exposure may increase the risk of cardiovascular disease, particularly in adult men. - Increasing mercury concentrations are now being found in a number of fish-eating wildlife species in remote areas of the planet. - The actual socioeconomic costs of mercury pollution are probably much greater than estimated because existing economic analyses don't consider mercury's impacts on ecosystems and wildlife. - The concentration of methylmercury in fish in freshwater and coastal ecosystems can be expected to decline with reduced mercury inputs; however, the rate of decline is expected to vary among water bodies, depending on the characteristics of a particular ecosystem. Besides Wiener, conference organizers included James Hurley of the University of Wisconsin-Madison Sea Grant Institute, David Krabbenhoft of the U.S. Geological Survey and Christopher L. Babiarz of the UW-Madison Water Science & Engineering Laboratory. Wisconsin Sea Grant, USGS and UW-La Crosse were among the major sponsors of the 2006 conference.


     




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