[Federal Register Volume 80, Number 50 (Monday, March 16, 2015)]
[Notices]
[Pages 13639-13641]
[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
[[Page 13641]]
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]
BILLING CODE 3710-F5-P
[Federal Register Volume 80, Number 64 (Friday, April 3, 2015)]
[Notices]
[Page 18269]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07649]
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OFFICE OF SCIENCE AND TECHNOLOGY POLICY
Impact of the Select Agent and Toxin Regulations; Correction
AGENCY: Office of Science and Technology Policy.
ACTION: Notice; correction.
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SUMMARY: The Office of Science and Technology Policy published a
document in the Federal Register Notice, 2015-05906, on March 16, 2015,
pages 13639-13641, concerning a Request for Public Comment on the
Impact of the Select Agent Regulations. The document contains incorrect
dates as we wish to extend the comment period to April 10, 2015, 5 p.m.
ET.
FOR FURTHER INFORMATION CONTACT: May Chu at (202)-456-6029.
Corrections
In the Federal Register of March 16, 2015, in the FR Doc. 2015-
05906,
(1) On page 13640 in the SUMMARY section (which starts on page
13639) in the first column, first line, correct the date to read:
5 p.m. ET on April 10, 2015 to be considered.
(2) On page 13640, first column, correct the DATES caption to read:
DATES: Documents must be received by 5:00 p.m. ET on April 10, 2015 to
be considered.
Dated: March 30, 2015.
Ted Wackler,
Deputy Chief of Staff and Assistant Director.
[FR Doc. 2015-07649 Filed 4-2-15; 8:45 am]
BILLING CODE 3170-F5-P
