[Federal Register Volume 80, Number 50 (Monday, March 16, 2015)]
[Notices]
[Pages 13639-13641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05906]


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OFFICE OF SCIENCE AND TECHNOLOGY POLICY


Impact of the Select Agent Regulations

ACTION: Request for Public Comment.

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SUMMARY: Public comment is requested on the impact that the Select 
Agent Regulations have had on science, technology, and national 
security, and on the benefits, costs, and limitations of these 
regulations. Drawing on these comments and other information available 
to it, a Fast Track Action Committee under the Committee on Homeland 
and National Security of the National Science and Technology Council 
will review the impacts and consider options to address the identified 
challenges or gaps concerning those regulations. Comments of up to 
three pages or fewer (12,000 characters) are requested and must be 
received by

[[Page 13640]]

5:00 p.m. ET on March 30, 2015 to be considered.

DATES: Comments must be received by 5:00 p.m. ET on March 30, 2015 to 
be considered.

ADDRESSES: You may submit comments by any of the following methods:
     Email: [email protected]. Include ``SAR Comments'' in 
the subject line of the message.
     Mail: Attn: Gerald L. Epstein, Ph.D., Co-Chair, Fast Track 
Action Committee, Deputy Assistant Secretary for Chemical, Biological, 
Radiological, and Nuclear Policy, U.S. Department of Homeland Security, 
245 Murray Lane SW., Mail Stop #0315, Washington, DC 20528. Please 
allow sufficient time for security processing of postal mail.
    Instructions: Response to this request for public comment is 
voluntary. Responses exceeding 12,000 characters or three pages will 
not be considered. Submission via email is preferred. Responses to this 
request for public comment may be posted online. The Office of Science 
and Technology Policy (OSTP) therefore requests that no business 
proprietary information, copyrighted information, or sensitive 
personally identifiable information be submitted in response to this 
request. Please note that the U.S. Government will not pay for response 
preparation, or for the use of any information contained in the 
response.

FOR FURTHER INFORMATION CONTACT: Gerald Epstein, Co-Chair, Fast Track 
Action Committee, at [email protected], (202) 282-9078.

SUPPLEMENTARY INFORMATION: This request for public comment offers the 
opportunity for interested individuals and organizations to comment on 
the impact that the Select Agent Regulations (SAR) have had on science, 
technology, and national security, and on the benefits, costs, and 
limitations of these regulations. The SAR (7 CFR part 331,9 CFR part 
121, and 42 CFR part 73, http://www.selectagents.gov/regulations.html) 
address the possession, use, and transfer of biological select agents 
and toxins--those agents and toxins that have been determined by the 
Secretary of Health and Human Services (HHS) or the Secretary of 
Agriculture as having the potential to pose a severe threat to public, 
animal or plant health or to animal or plant products. It is important 
that biological select agents and toxins are regulated in a way that 
effectively allows for research and development to enhance science, 
health, and national security.

White House Memorandum for Enhancing Biosafety and Biosecurity

    Broad stakeholder engagement with respect to the impact of the SAR 
is one of the items called for in an August 18, 2014, White House memo 
on Enhancing Biosafety and Biosecurity in the United States, which 
outlined a series of immediate and longer-term steps the government 
would take to address the underlying causes of a series of biosafety 
incidents at U.S. government laboratories earlier that year. Though 
most of the actions were directed at federally funded laboratories, the 
Memo recognized that many stakeholders (e.g., regulators, regulated, or 
other parties interested in the SAR) could provide a broader, deeper 
understanding of the impact of the SAR.

Questions Regarding the Select Agent and Toxin Regulations

    We invite comments on any aspect of the SAR. Comments are sought 
that identify concrete impacts and/or propose recommendations to 
ameliorate or resolve identified challenges or gaps. We welcome 
comments that separately address the implementation of the SAR 
(including the costs, benefits and impacts of implementation), the 
regulations themselves, and any broader issues pertaining to the safety 
and security of potentially dangerous biological microorganisms and 
toxins.
    While all comments are welcome, the following questions may help 
you frame your response:
    1. What are the specific benefits, challenges, and impacts in 
implementing the SAR with respect to: (1) Scientific research (e.g., 
quality, breadth, international competitiveness, or other outcomes or 
consequences)?; (2) safety and security (e.g., biocontainment, 
biosafety, physical security, cybersecurity, and personnel 
suitability)?; and, 3. public or agricultural health and response (e.g. 
ability to respond rapidly and effectively to incidents and the 
development/availability of medical countermeasures)?
    2. What gaps exist in the SAR (e.g., reporting, aggregated data 
collection, ability to transfer material across international borders) 
and what specific recommendations would fill those gaps?
    3. Are facilities that possess, use, or transfer biological select 
agents and toxins in the U.S. safer than they were before the SAR went 
into effect in close to its current form in 2003? If so, to what extent 
are the SAR responsible?
    4. The SAR strike a balance between avoiding harm (e.g., preventing 
safety or security lapses) and seeking benefits (e.g., conducting 
research and public or agricultural health activities). Do you think 
that balance has been struck appropriately? If not, what specific 
aspects of the SAR should be emphasized more, and what should be 
emphasized less?
    5. Have the regulations unduly impaired research and other 
applications of select agents and toxins? If so, how? Please provide 
examples as appropriate, with specific sections of the SAR if possible.
    6. If the SAR have unduly impaired research, how can the research 
and other applications be further promoted, while still protecting 
against misuse and accidental release? Please provide examples as 
appropriate, with specific aspects of the SAR if possible.
    7. Have the regulations sufficiently protected public and 
agricultural health and safety against the misuse and accidental 
release of these agents? If so, or if not, how? Please provide examples 
as appropriate, with specific sections of the SAR if possible.
    8. If the SAR are not sufficient for health and safety protection, 
how can health and safety be better protected while still facilitating 
legitimate use of select agents and toxins? Please provide recommended 
changes to the specific sections of the SAR if appropriate.
    9. Describe how the overall costs of the SAR are or are not 
appropriately balanced with their overall benefits.
    10. The SAR regulate the use, transfer, or possession of a specific 
list of potentially dangerous pathogens and toxins. Is designing the 
regulations around a list of agents advantageous or disadvantageous? If 
disadvantageous, in what other way can the regulations be organized and 
implemented?
    11. Research today is a thoroughly international activity, with 
scientists and research materials constantly crossing national borders. 
Security threats today likewise extend across national borders. Are the 
SAR appropriately configured to accommodate these international issues? 
If not, how could they be improved?
    12. Are the SAR appropriately configured to accommodate changes in 
science and technology such as, but not limited to, advances in 
synthetic biology, genetic engineering, or viral systematics? If not, 
how can they be reconfigured to better do so? What scientific and 
technical advances might

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improve the function or lessen the costs and burdens of the SAR?

Ted Wackler,
Deputy Chief of Staff and Assistant Director.
[FR Doc. 2015-05906 Filed 3-13-15; 8:45 am]
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