e-Public Policy Update - October 2012

Contents:

  • Important Changes to Select Agent Regulations Published
  • ASM Receives the APHL Award for Excellence in Developing LRN Scientific Guidelines
  • ASM Sends Legislative Alert to Members Regarding Budget Sequester
  • ASM Cosigns Coalition Letter on Research Policy Issues
  • ASM Participates in Policy Meetings
  • ASM Invited to PCAST Report Release Event
  • Joint Commission New Portal for Accredited Labs
  • ASM mBio® Commentaries: Research on Enhanced Transmissibility in H5N1 Influenza: Should the Moratorium End?
  • CDC’s NCEZID Releases First Strategic Plan
  • ASM Congressional Science Fellow Placement
  • ASM General Meeting Minority Travel Grant

Important Changes to Select Agent Regulations Published
The Department of Health and Human Services (HHS) and the USDA Animal and Plant Health Inspection Service (APHIS) published regulatory changes to the Select Agent and Toxin rules in the October 5, 2012 Federal Register. The final rule changes implement the findings of the third biennial review of the Select Agent and Toxin lists. The final rules modify the list of Select Agents and Toxins, designate a subset of the list of Select Agents and Toxins as Tier 1 based on their risk to be deliberately misused, and change security requirements for entities possessing Tier 1 Select Agents and Toxins. On October 11, the Public and Scientific Affairs Board sent an alert to all ASM members informing them of the changes.

Highlights of the DHHS changes include:

  • The following viruses are added to the HHS select agent list “based on scientific data related to their significant public health risk”: SARS-CoV, Lujo and Chapare viruses
  • The following agents are removed from the list of HHS and overlap select agents and toxins: Herpes B virus, Clostridium perfringens epsilon toxin, Coccidioides posadasii/Coccidioides immitis, Eastern Equine Encephalitis virus (South American type only), Flexal virus, West African clade of Monkeypox virus, Rickettsia rickettsii, the non-short, paralytic alpha conotoxins containing the following amino acid sequence, CCX2, PACGX3, X4, X5, X6, CX7, Shigatoxins, Shiga-like ribosome inactivating proteins, Staphylococcal Enterotoxins L(non-A, non-B, non-C, non-D, and non-E subtypes and Tick-borne encephalitis complex viruses (Central European subtype)
  • The following agent would no longer be considered an overlap select agent: Venezuelan Equine Encephalitis Virus (subtypes ID and IE)
  • Executive Order 13546 directed HHS to designate a subset of the select agent and toxin list as Tier 1, a category that presents the greatest risk of deliberate misuse with the greatest potential for mass casualties or devastating effects to the economy, critical infrastructure or public confidence. There are eight (8) HHS Tier 1 select agents and toxins: Ebola virus, Francisella tularensis, Marburg virus, Variola major virus, Variola minor virus, Yersinia pestis, Botulinum neurotoxin, Botulinum neurotoxin producing species of Clostridium; and three (3) Tier 1 Overlap select agents and toxins: Bacillus anthracis, Burkholderia mallei, and Burkholderia pseudomallei
  • There are changes in the rules for physical security for entities possessing Tier 1 select agents and toxins, including requirements for pre-access assessments and monitoring of personnel with access to Tier 1 agents and toxins
  • There are miscellaneous revisions to the regulations concerning security, training, biosafety and incident response
  • The effective date for amendments to 73.1, 73.3-73.6, 73.9. 73.10, 73.13, 73.16, 73.17 and 73.20 is December 4, 2012.The remaining provisions of the final rule are effective April 3, 2013.

Highlights of the APHIS changes include:

  • The following agents would no longer be considered PPQ select agents or toxins, or would be excluded from compliance with the select agent regulations: Any subspecies of Ralstonia olanacearum except race 3, biovar 2 and all subspecies of Sclerophthora rayssiae except var. zeae, and Xylella fastidiosa, citrus variegated chlorosis (CVC) strain.
  • The following agents would no longer be considered VS select agents or toxins, or would be excluded from compliance with the select agent regulations: Any low pathogenic strains of avian influenza virus, any strain of Newcastle disease virus which does not meet the criteria for virulent Newcastle disease virus, all subspecies Mycoplasma capricolum except subspecies capripneumoniae (contagious caprine pleuropneumonia), and all subspecies Mycoplasma mycoides except subspecies mycoides small colony (Mmm SC) (contagious bovine pleuropneumonia), Akabane virus; Bluetongue virus (exotic), Bovine spongiform encephalopathy agent; Camel pox virus; Ehrlichia ruminantium (Heartwater); Japanese encephalitis virus; Malignant catarrhal fever virus (Alcelaphine herpesvirus type 1); Menangle virus; and Vesicular stomatitis virus (exotic): Indiana subtypes VSV-IN2, VSV-IN3.
  • The following agent would no longer be considered a VS/Department of Health and Human Services (HHS) overlap select agent: Venezuelan Equine Encephalitis Virus (subtypes ID and IE).
  • Tiering of the select agent and toxin lists:
    • Tier 1 select agents and toxins: PPQ select agents and toxins: None.
    • VS select agents and toxins: Foot-and-mouth disease virus and Rinderpest virus.
    • VS/HHS overlap select agents and toxins: Bacillus anthracis, Burkholderia mallei, and Burkholderia pseudomallei.
  • Establishes physical security standards for entities possessing Tier 1 select agents and toxins, including the requirement to conduct pre-access assessments and ongoing monitoring of personnel with access to Tier 1 agents and toxins;
  • Miscellaneous revisions to the regulations to clarify regulatory language concerning security, training, biosafety, and incident response.

The Centers for Disease Control and Prevention is holding a 2012 Select Agent Workshop, which will be broadcasted via webcast-only on Friday, November 16 from 9:00 am to 5:00 p.m (EST). The Workshop will cover the following topics: 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). All who wish to participate in the webcast must register for the workshop. There is no charge for registration. Registration forms are due no later than October 16, 2012.

To register for the webinar go to: http://www.selectagents.gov/resources/2012_Fall_SA_Workshop_Registration_Form_English.pdf. For updates regarding the Federal Select Agent Program or if you have problems with the workshop link go to http://www.selectagents.gov/

The HHS and APHIS Federal Register notices are available on the ASM webpage at: http://asm.org/index.php/public-policy-2/97-policy/documents/8417-sa-10-9-12

ASM Receives the APHL Award for Excellence in Developing LRN Scientific Guidelines
The Association of Public Health Laboratories (APHL) recognized the ASM with the Award for Excellence in Developing Scientific Guidelines on October 10 at their 2012 Laboratory Response Network (LRN) National Meeting in Denver, CO.   This award is given to an organization which has made significant contributions to the advancement of LRN practices and policies, positively influencing the network and its members. For over a decade, ASM has maintained the Sentinel Level Clinical Microbiology Laboratory Guidelines for Suspected Agents of Bioterrorism and Emerging Infectious Diseases and continues to make improvements to these important guidelines, which are used by all Sentinel laboratories. PSAB Committee on Laboratory Practices member James Snyder attended the meeting and received the award for ASM. Dr. Snyder represents ASM in the LRN and is assisted by Alice Weissfeld of the Professional Affairs Committee.  The Laboratory Response Network was established in accordance with Presidential Decision Directive 39 in 1999 to improve US readiness for bioterrorism and is equipped to respond to acts of biological or chemical terrorism, emerging infectious disease, natural disasters and other public health threats. To see the current guidelines, visit our page http://www.asm.org/index.php/issues/sentinel-laboratory-guidelines. For more information on the LRN, see http://emergency.cdc.gov/lrn/.

ASM Sends Legislative Alert to Members Regarding Budget Sequester
In September, the ASM Public and Scientific Affairs Board sent a Legislative Alert to members regarding the negative impact of the upcoming automatic across the board cuts to both defense and non-defense discretionary spending, known as sequestration, 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. These mandatory cuts, set to be enacted on January 2, 2013, will have a devastating effect 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. ASM members sent approximately 2,000 messages to members of Congress regarding the cuts. To see the alert go to: http://asm.org/index.php/public-policy-2/93-policy/8380-la-seq.

ASM Cosigns Coalition Letter on Research Policy Issues
The ASM joined more than 200 science and health organizations in an October 1 letter expressing concerns about research policy provisions for the National Institutes of Health (NIH) included in the FY 2013 spending bill adopted by the House Labor-HHS-Education subcommittee July 18. The letter was sent to Subcommittee Chair Dennis Rehberg (R-MT) and Ranking Member Rosa DeLauro (D-CT). The letter stated that the bill provides insufficient funds for NIH and prescriptive language that would impede NIH’s ability to manage its portfolio. The letter urged the committee to allow NIH to continue to fund the highest quality research and the next generation of talented researchers in the most effective manner possible. To read the letter go to: http://asm.org/images/PSAB/LHHS-Sign-on10-1-12_final.pdf.

ASM Participates in Policy Meetings
In September and October, ASM was represented by staff at coalition and other meetings including a September 20, press conference titled, “The Unkindest Cut of All: Sequestration's Impact on NIH, from Patients to Research to Jobs” held by United for Medical Research and Research!America. Speakers included: Representatives Ed Markey (D-MA) and Brian Bilbray (R-CA) and focused on the potential impacts of sequestration on public health and research. On October 2, a meeting of the Washington Animal Research Network (WARN) where issues including: air transportation of research animals, the use of chimpanzees in research and the Great Ape Protection Cost Savings Act as well as upcoming Congressional activities were discussed. On October 10, the ASM, as a founding member of the Supporters of Agricultural Research (SOAR) coalition, attended the group’s first organizational meeting in Washington DC. Issues discussed included communications strategies, goals and membership efforts. For more information on SOAR please visit: http://supportagresearch.org/ The Public Affairs staff also met with staff from the White House Office of Science and Technology Policy (OSTP) on October 11 to discuss policies of interest to microbiology.

ASM Staff Attends PCAST Report Release Event
On September 25 The President’s Council of Advisors on Science and Technology (PCAST) released its Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation in partnership with and hosted by the Institute of Medicine (IOM) and the National Academy of Sciences (NAS) in Washington, DC. The speakers for the event included PCAST Co-Chairs John Holdren, Advisor to the President for Science and Technology, and Eric Lander; and Margaret Hamburg, the Commissioner of the Food and Drug Administration (FDA). You can this report, and others from PCAST, by going to the link http://www.whitehouse.gov/administration/eop/ostp/pcast/docsreports.

The ASM is a cosponsor of the Institute of Medicine’s Forum on Drug Discovery, Development, and Translation. The Forum sponsors meetings with leaders from federal agencies, non-profit associations and the private sector to discuss issues related to drug discovery and regulatory approval to translation of research into clinical practice. In the past year the Forum has held meetings on Multidrug-Resistant TB and clinical trials. More information on the Forum and links to its reports are available on-line at: http://www.iom.edu/Activities/Research/DrugForum.aspx.

Joint Commission New Portal for Accredited Labs
In August, The Joint Commission announced the launch of Lab Central Connect™ for accredited laboratories. The Joint Commission is a non-profit organization that accredits and certifies more than 19,000 health care organizations and programs in the United States to improve health care for the public. The portal is designed to help Joint Commission-accredited laboratories centralize storage of important survey-related documents, as well as improve safety and quality by helping to maintain continuous compliance with Joint Commission standards. A distance training exercise occurred during the 19 September Laboratory Professional and Technical Advisory Committee Members (LAB PTAC) conference call to acquaint members with the resources available of the portal. ASM’s LAB PTAC Representative Yvette McCarter, from the PSAB Committee on Laboratory Practices and ASM Staff took part in the training. To read more about Lab Central Connect™, go to http://www.jointcommission.org/lab_central_connect_portal/.

ASM mBio® Commentaries: Research on Enhanced Transmissibility in H5N1 Influenza: Should the Moratorium End?
How can scientists safely conduct avian flu research if the results could potentially threaten, as well as save, millions of lives? In a series of commentaries appearing on Tuesday, October 9 in mBio®, the online open-access journal of the American Society for Microbiology, prominent microbiologists and physicians argue the cases both for and against lifting a voluntary moratorium on experiments to enhance the ability of the H5N1 virus to move from mammal to mammal, so-called “gain-of-function” research, and discuss the level of biosecurity that would be appropriate for moving that research forward. Commentaries by Ron Fouchier of Erasmus MC Rotterdam in The Netherlands, Adolfo García-Sastre of the Mount Sinai School of Medicine, and Yoshihiro Kawaoka of the University of Wisconsin-Madison, Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, Marc Lipsitch and Barry R. Bloom of the Harvard School of Public Health, Ian Lipkin of Columbia University and Stanley Falkow of Stanford University are featured. To read the commentaries go to the mBio® website: http://mbio.asm.org/.

CDC’s NCEZID Releases First Strategic Plan
The Center for Disease Control and Prevention’s National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) is releasing its first strategic plan since the Center’s inception in 2010.  The plan is posted on the NCEZID website at http://www.cdc.gov/ncezid/. The plan lays out the priority work for the Center for the next 5 years (2012-2017) with four strategies.  Each strategy has a set of selected strategic objectives and specific actions associated with it. The strategies and objectives build upon the principles described in CDC’s Office of Infectious Diseases’ A CDC Framework for Preventing Infectious Diseases:  Sustaining the Essentials and Innovating for the Future, which serves as a roadmap for all of CDC’s infectious disease work.  The NCEZID strategic plan also aligns with CDC priorities to strengthen surveillance and epidemiology, enhance the agency’s ability to support state and local public health, provide leadership in global health, promote effective public health policy, and to address the causes of death, illness, and disability. 

ASM Congressional Science Fellow Placement
Kristen E. Shatynski, Ph.D., ASM’s 2012-2013 Congressional Science Fellow has found a placement in the office of Representative Devin Nunes (R-CA). The American Society for Microbiology has supported Congressional Fellows since 1977. The ASM Congressional Science Fellowship Selection Committee selects a postdoctoral to mid-career microbiologist to spend one year on the staff of an individual congressman, congressional committee, or with some other appropriate organizational unit of Congress.   Prospective Fellows must be citizens of the United States, members of ASM for at least one year and must have completed their Ph.D. by the time the fellowship begins in September. The Congressional Science Fellowship is supported in part by the Frobisher Fund, a bequest made to ASM by Martin Frobisher.   Contact the Office of Public Affairs at publicaffairs@asmusa.org for more information on the ASM fellowship or go to the ASM web page for a program description: http://asm.org/index.php?option=com_content&view=article&id=7535. The deadline for applications for the 2013 – 2014 fellowship is February 22, 2013.

ASM General Meeting Minority Travel Grant
In an effort to increase the participation of underrepresented minority (URM) groups in microbiology related fields, ASM will offer American General Meeting Minority Travel Grants to help defray expenses associated with travel to asm2013. Postdoctoral scholars, faculty from URM groups, and faculty from Minority Serving Institutions and Community Colleges who have demonstrated their interest in mentoring URM trainees in the microbiological sciences will be eligible to receive up to $2,000. Funding for this program is pending. For complete details on eligibility requirements, selection criteria, and to download the application form, please visit http:www.asm.org/asmgmminoritytravelgrant.

TPL_asm2013_SEARCH