e-Public Policy Newsletter - September 2012

  • Legislative Alert: Contact Congress Regarding Sequestration Risks to Science and Public Health Programs
  • Revision of the NIH Guidelines to Include Synthetic Nucleic Acids and Clarification of Criteria for Section III-A-1-a Experiments
  • Science Funding Update
  • ASM Collaborates with the Clinical Laboratory Standards Institute on Laboratory Developed Tests
  • ASM Participates in September Coordinating Council on the Clinical Laboratory Workforce Meeting
  • International Infection Prevention Week (IIPW)
  • Update on Travel Restrictions for Government Scientists
  • CDC Webcast on Compliance with the Federal Select Agent Program

Legislative Alert: Contact Congress Regarding Sequestration Risks to Science and Public Health Programs
As a result of the Budget Control Act of 2011 and failure by the Joint Select Committee on Deficit Reduction to reduce the Nation’s debt by $1.2 trillion, automatic across the board cuts to both defense and non-defense discretionary spending, known as sequestration, are set to be enacted on January 2, 2013. These mandatory cuts will have a devastating impact on the research and public health programs supported by federal agencies such as the National Institutes of Health, the Centers for Disease Control and Prevention, the National Science Foundation, the U.S. Department of Agriculture, the Food and Drug Administration, the Department of Energy and others. The White House sequestration report details the alarming effects of the scheduled indiscriminate cuts on science and public health programs.

The American Society for Microbiology (ASM) encourages its members to contact their representative and senators about the negative impact the upcoming sequestration would have on science and public health. Go to the ASM’s Legislative Action Center at http://capwiz.com/asmusa/issues/alert/?alertid=61879501 to e-mail your members of Congress and ask them to take action to avoid the dire consequences of sequestration, or arbitrary across the board cuts, before January 1.

Revision of the NIH Guidelines to Include Synthetic Nucleic Acids and Clarification of Criteria for Section III-A-1-a Experiments
On March 4, 2009, the NIH Office of Biotechnology Activities (OBA), Office of Science Policy published a proposal in the Federal Register (March 2009, 74 FR 9411) to make two revisions to the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines). One proposed revision was to address the biosafety considerations for research with synthetic nucleic acids. NIH proposed modifying the NIH Guidelines to cover explicitly certain basic and clinical research with nucleic acid molecules created solely by synthetic means. Another proposed revision was to modify the criteria for determining whether an experiment to introduce drug resistance into a microorganism must be reviewed by the Recombinant DNA Advisory Committee (RAC) and approved by the NIH Director (as a Major Action under Section III-A-1-a of the NIH Guidelines).

The ASM submitted comments to the proposed changes in the guidelines. Specifically, the ASM letter (April 9, 2009 - ASM Comments on Revisions to the NIH Guidelines for Research Involving Recombinant DNA Molecules) commenting on the 2009 proposed action expressed concern about the change in Section III-A-I because it changed and broadened the review for experiments involving deliberate transfer of a drug resistance trait to microorganisms.

On September 5, 2012, the NIH published a Final Action which sets forth the final revisions to the NIH Guidelines that 1) modify the scope of the NIH Guidelines to cover explicitly certain research with synthetic nucleic acids, and 2) clarify the criteria for NIH review of research involving the introduction of therapeutic drug resistance into microorganisms. The September 5 Federal Register notice describes changes made to several sections of the NIH Guidelines to address explicitly biosafety for certain types of basic and clinical research with synthetic nucleic acids. In light of these changes, the title of the NIH Guidelines will also be revised from NIH Guidelines for Research Involving Recombinant DNA Molecules to NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

The final revisions to the NIH guidelines represent a significant modification to the changes proposed in March of 2009. The NIH/OBA agreed with ASM and other comments that the phrase “not known to acquire the trait naturally” serves to identify the majority of experiments that potentially pose higher risk to public health and should be retained. The amended NIH Guidelines attempt to clarify whether a particular experiment involving the introduction of a drug resistance trait into a microorganism warrants review by the RAC and approval by the NIH Director under Section III-A-1-a of the NIH Guidelines. The current NIH Guideline criteria for determining whether an experiment requires review under Section III-A-1-a are being retained with clarifying language added regarding the assessment of whether a drug is therapeutically useful.   The Federal Register notice and a FAQ detailing these revisions are available on the NIH website.

These changes are effective March 5, 2013, six months from the date of publication. All ongoing and proposed experiments with synthetic nucleic acids that will be newly subject to these amended NIH Guidelines will need to be registered by the Principal Investigator with the Institutional Biosafety Committee by the effective date listed above. The six-month time frame was deemed sufficient to allow institutions to develop new procedures, as well as outreach and training for investigators whose research will now be subject to the NIH Guidelines.

Science Funding Update
On September 10, the House Appropriations Committee introduced a six-month continuing resolution (CR), H.J.R. 117 that would avoid a government shutdown and fund all federal agencies, with few exceptions, at the FY 2012 levels until March 27, 2013. H.J.R. 117 includes an across-the-board increase of .6 percent to account for a higher discretionary spending cap as well as a new requirement that each federal agency provide spending plans to Congress.

A copy of the legislation can be found on the GPO website by clicking here.

In September, ASM staff attended a town hall meeting of NDD United, a loosely organized ad hoc coalition created in part by the Coalition for Health Funding after the passage of the Budget Control Act of 2011 to oppose further cuts to nondefense discretionary programs. The meeting was held to discuss potential impacts of the upcoming sequestration implementation on funding for health and science research and development (r&d) programs.   Robert Gordon, Executive Associate Director, Office of Management and Budget (OMB) and Jon Carson, Director of the White House Office of Public Engagement, spoke to the group. On September 14, the White House, as required by The Sequestration Transparency Act of 2012, released a report on sequestration outlining the Administration’s plan to implement the broad across-the-board cuts to federal agencies. The report indicated that science and research programs, as “non-exempt nondefense discretionary funding” would receive an 8.2 percent reduction in 2013. A copy of the report can be found by clicking here.  As a result of the Budget Control Act of 2011 and failure by the Congressional Joint Select Committee on Deficit Reduction to reduce the Nation’s debt by $1.2 trillion, automatic across-the-board cuts to both defense and non-defense discretionary spending, known as sequestration, are set to be enacted on January 2, 2013.  

Further updates on funding issues are available on the Public Affairs website at: Research and Development Funding for FY 2013

ASM Collaborates with the Clinical Laboratory Standards Institute on Laboratory Developed Tests
The Clinical and Laboratory Standards Institute (CLSI) has partnered with ASM on an Evaluation Project.   This project will revise a CLSI internal document; ASM will be assisting by adding a new microbiology section prior to distribution. One of the important topics which will be covered in the new section is laboratory developed tests (LTDs). Two PSAB committee members, Eileen Burd, Committee on Laboratory Practices, and Alice Weissfeld, Professional Affairs Committee and ASM voting member of CLSI, are key participants in the drafting of this important document. They both attended a two day meeting September 8-9 in Scottsdale, AZ to begin the work on the LDT section. CLSI is a global, nonprofit, standards-developing organization that promotes the development and use of voluntary consensus standards and guidelines within the health care community.   To read more about CLSI, please go to http://www.clsi.org/

ASM Participates in September Coordinating Council on the Clinical Laboratory Workforce Meeting
On September 10, PSAB Professional Affairs Committee chair Vickie Baselski attended the Coordinating Council on the Clinical Laboratory Workforce (CCCLW) Meeting in Chicago, IL. The Council discussed strategies for increasing the visibility of clinical laboratory careers, recent changes in fee structure and leadership, and initiatives undertaken by various member societies to publicize the clinical laboratory. CCCLW, in existence since 2000, is a united voice of 20 clinical laboratory organizations and stakeholders, including ASM, and focuses on collective efforts to increase the number of qualified clinical laboratory professionals and to increase healthcare and public awareness of the laboratory professional’s role in achieving positive patient outcomes.

International Infection Prevention Week (IIPW)
The ASM has joined with the Association for Professionals in Infection Control and Epidemiology (APIC) and other healthcare associations to become a Supporting Partner of the International Infection Prevention Week (IIPW). The IIPW, which takes place October 14-20, provides a focal point for healthcare professionals across the spectrum (administrative, clinical, academic, industry) to shine a light on infection prevention and its impact. The goals of the IIPW are to engage the public about how they can prevent the spread of infection in community and healthcare settings. In addition, a new legislative toolkit helps effectively bring the infection prevention message to state law and policy makers. For more information on IIPW go to: http://iipw.site.apic.org/.

Update on Travel Restrictions for Government Scientists
On September 11, the House passed HR 4631, the GSA Act of 2012, a bill to reduce federal spending in the aftermath of the GSA meeting scandal in Las Vegas, NV. Unlike the last travel prohibition passed by the House (the DATA Act HR 2146), this legislation would not limit the number of meetings federal employees could attend annually or potentially require financial disclosures from the association holding the meeting. The ASM has been active in monitoring and responding to this legislation. In May, the ASM sent a letter to Congress urging members to revise the legislative language that severely restricted government employees from attending meetings and conferences held by scientific organizations, other associations and the private sector. The letter was in response to amendments to two different bills that passed the House and the Senate in April. The ASM believed that the amendments were broader in scope than was necessary to meet the goals of the legislation and would seriously impact scientific research and public health initiatives of agencies such as the National Institutes of Health and the Centers for Disease Control and Prevention. The ASM also signed onto many coalition letters that were sent to Congress. To read ASM’s letter, which includes the original and revised legislation go to: May 17, 2012 - ASM Sends Letter to Congress on Government Scientist Travel Restriction Amendments. ASM will continue to monitor this issue and update members of any changes.

CDC Webcast on Compliance with the Federal Select Agent Program
The Centers for Disease Control and Prevention (CDC) announced the notice of a public webcast concerning compliance with the Federal Select Agent Program. The webcast is organized by the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (USDA/APHIS), the Department of Health and Human Services Centers for Disease Control and Prevention (HHS/CDC), and the Department of Justice’s Federal Bureau of Investigation (FBI). Issues to be discussed include changes to the select agent regulations; occupational health, information and physical security; personnel suitability; Bioterrorism Security Risk Assessment Form (FD–961 form); and changes to the Application for Laboratory Registration for Possession, Use, and Transfer of Select Agents and Toxins (APHIS/CDC Form 1). The webcast will be held on Friday, November 16, 2012 from 9 a.m. to 5 p.m. EST. All who wish to join the webcast must register by October 16, 2012. Registration instructions are found on the Federal Select Agent Program Web site, http://www.selectagents.gov.

 

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