Impact of the Select Agent Regulations, 13639-13641 [2015-05906]
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Federal Register / Vol. 80, No. 50 / Monday, March 16, 2015 / Notices
contacting the identified DFO.
Moreover, in view of the possibility that
the schedule for ACRS meetings may be
adjusted by the Chairman as necessary
to facilitate the conduct of the meeting,
persons planning to attend should check
with these references if such
rescheduling would result in a major
inconvenience.
If attending this meeting, please enter
through the One White Flint North
building, 11555 Rockville Pike,
Rockville, MD. After registering with
security, please contact Mr. Theron
Brown (Telephone 240–888–9835) to be
escorted to the meeting room.
Dated: March 9, 2015.
Mark L. Banks,
Chief, Technical Support Branch, Advisory
Committee on Reactor Safeguards.
[FR Doc. 2015–05946 Filed 3–13–15; 8:45 am]
BILLING CODE 7590–01–P
NUCLEAR REGULATORY
COMMISSION
Advisory Committee on Reactor
Safeguards (ACRS); Meeting of the
ACRS Subcommittee on Fukushima;
Notice of Meeting
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The ACRS Subcommittee on
Fukushima will hold a meeting on
March 20, 2015, Room T–2B1, 11545
Rockville Pike, Rockville, Maryland.
The meeting will be open to public
attendance.
The agenda for the subject meeting
shall be as follows:
Friday, March 20, 2015—8:30 a.m.
Until 12:00 p.m.
The Subcommittee will review and
discuss the development of an Interim
Staff Guidance in support of Order EA–
13–109, Reliable Hardened Vents, Phase
2. The Subcommittee will hear
presentations by and hold discussions
with the NRC staff and other interested
persons regarding this matter. The
Subcommittee will gather information,
analyze relevant issues and facts, and
formulate proposed positions and
actions, as appropriate, for deliberation
by the Full Committee.
Members of the public desiring to
provide oral statements and/or written
comments should notify the Designated
Federal Official (DFO), Weidong Wang
(Telephone 301–415–6279 or Email:
Weidong.Wang@nrc.gov) five days prior
to the meeting, if possible, so that
appropriate arrangements can be made.
Thirty-five hard copies of each
presentation or handout should be
provided to the DFO thirty minutes
before the meeting. In addition, one
electronic copy of each presentation
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should be emailed to the DFO one day
before the meeting. If an electronic copy
cannot be provided within this
timeframe, presenters should provide
the DFO with a CD containing each
presentation at least thirty minutes
before the meeting. Electronic
recordings will be permitted only
during those portions of the meeting
that are open to the public. Detailed
procedures for the conduct of and
participation in ACRS meetings were
published in the Federal Register on
October 13, 2014, (79 FR 59307).
Detailed meeting agendas and meeting
transcripts are available on the NRC
Web site at https://www.nrc.gov/readingrm/doc-collections/acrs. Information
regarding topics to be discussed,
changes to the agenda, whether the
meeting has been canceled or
rescheduled, and the time allotted to
present oral statements can be obtained
from the Web site cited above or by
contacting the identified DFO.
Moreover, in view of the possibility that
the schedule for ACRS meetings may be
adjusted by the Chairman as necessary
to facilitate the conduct of the meeting,
persons planning to attend should check
with these references if such
rescheduling would result in a major
inconvenience.
If attending this meeting, please enter
through the One White Flint North
building, 11555 Rockville Pike,
Rockville, MD. After registering with
security, please contact Mr. Theron
Brown (Telephone 240–888–9835) to be
escorted to the meeting room.
13639
hearing, and petition for leave to
intervene; order, correction.
The U.S. Nuclear Regulatory
Commission (NRC) is correcting a notice
that was published in the Federal
Register on February 3, 2015, that
contained an amendment request for
Perry Nuclear Plant, Unit 1. This action
is being taken to correct the date of the
NRC’s Agencywide Documents Access
and Management System (ADAMS)
accession number for the amendment
request from FirstEnergy Nuclear
Operating Company.
FOR FURTHER INFORMATION CONTACT: Eva
A. Brown, Office of Nuclear Reactor
Regulation, U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
0001; telephone: 301–415–2315; email:
Eva.Brown@nrc.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of February 3, 2015 (80
FR 5816), FR Doc. 2015–01917, on page
5819, in the middle of the second
column, under ‘‘FirstEnergy Nuclear
Operating Company, Docket No. 50–
440, Perry Nuclear Power Plant, Unit 1,
Lake County, Perry Ohio,’’ after ‘‘Date of
amendment request,’’ the date
‘‘September 12, 2014’’ is corrected to
read ‘‘October 8, 2014.’’
SUMMARY:
Dated in Rockville, Maryland, this 9th day
of March, 2015.
For the Nuclear Regulatory Commission.
Eva A. Brown,
Senior Project Manager, Plant Licensing III–
2 and Planning and Analysis Branch, Division
of Operating Reactor Licensing, Office of
Nuclear Reactor Regulation.
Date: March 9, 2015.
Mark L. Banks,
Chief, Technical Support Branch, Advisory
Committee on Reactor Safeguards.
[FR Doc. 2015–05944 Filed 3–13–15; 8:45 am]
[FR Doc. 2015–05988 Filed 3–13–15; 8:45 am]
OFFICE OF SCIENCE AND
TECHNOLOGY POLICY
BILLING CODE 7590–01–P
Impact of the Select Agent Regulations
NUCLEAR REGULATORY
COMMISSION
ACTION:
Applications and Amendments to
Facility Operating Licenses and
Combined Licenses Involving
Proposed No Significant Hazards
Considerations and Containing
Sensitive Unclassified Non-Safeguards
Information and Order Imposing
Procedures for Access to Sensitive
Unclassified Non-Safeguards
Information; Corrections
Nuclear Regulatory
Commission.
ACTION: License amendment request;
opportunity to comment, request a
AGENCY:
Frm 00126
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Request for Public Comment.
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
SUMMARY:
[NRC–2015–0007]
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BILLING CODE 7590–01–P
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Federal Register / Vol. 80, No. 50 / Monday, March 16, 2015 / Notices
5:00 p.m. ET on March 30, 2015 to be
considered.
White House Memorandum for
Enhancing Biosafety and Biosecurity
Comments must be received by
5:00 p.m. ET on March 30, 2015 to be
considered.
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.
DATES:
You may submit comments
by any of the following methods:
• Email: SAReview@hq.dhs.gov.
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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Gerald Epstein, Co-Chair, Fast Track
Action Committee, at SAReview@
hq.dhs.gov, (202) 282–9078.
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,
https://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.
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SUPPLEMENTARY INFORMATION:
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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
PO 00000
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Fmt 4703
Sfmt 4703
(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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Federal Register / Vol. 80, No. 50 / Monday, March 16, 2015 / Notices
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
SECURITIES AND EXCHANGE
COMMISSION
[Release No. 34–74460; File No. SR–Phlx–
2015–21]
Self-Regulatory Organizations;
NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of
Proposed Rule Change Relating to
Customer Rebate Program, Multiply
Listed Options, PIXL Pricing
March 10, 2015.
Pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (the
‘‘Act’’),1 and Rule 19b–4 thereunder,2
notice is hereby given that on February
26, 2015, NASDAQ OMX PHLX LLC
(‘‘Phlx’’ or ‘‘Exchange’’) filed with the
Securities and Exchange Commission
(‘‘SEC’’ or ‘‘Commission’’) the proposed
rule change as described in Items I, II,
and III below, which Items have been
prepared by the Exchange. The
Commission is publishing this notice to
solicit comments on the proposed rule
change from interested persons.
I. Self-Regulatory Organization’s
Statement of the Terms of the Substance
of the Proposed Rule Change
The Exchange proposes to modify the
Phlx Pricing Schedule (‘‘Pricing
Schedule’’). Specifically, the Exchange
proposes to amend pricing in Section B,
entitled ‘‘Customer Rebate Program,’’
Section II, entitled ‘‘Multiply Listed
Options Fees,’’ 3 and Section IV, Part A,
entitled ‘‘PIXL Pricing,’’ 4 of the Pricing
Schedule. The Exchange proposes these
amendments in order to: (i) Establish a
cap on rebates specifically for electronic
Simple PIXL and Complex 5 PIXL
1 15
U.S.C. 78s(b)(1).
CFR 240.19b–4.
3 This includes options overlying equities,
exchange traded funds (‘‘ETFs’’), exchange traded
notes (‘‘ETNs’’) and indexes which are Multiply
Listed.
4 PIXLSM is the Exchange’s price improvement
mechanism known as Price Improvement XL or
PIXL. See Rule 1080(n).
5 A Complex Order is any order involving the
simultaneous purchase and/or sale of two or more
different options series in the same underlying
security, priced at a net debit or credit based on the
relative prices of the individual components, for the
same account, for the purpose of executing a
particular investment strategy. Furthermore, a
Complex Order can also be a stock-option order,
which is an order to buy or sell a stated number
of units of an underlying stock or ETF coupled with
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2 17
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Orders and not pay rebates when
electronic 6 Customer 7 Complex PIXL
Orders execute against electronic
Complex PIXL Initiating Orders; (ii)
increase the assessment of fees for
electronic Firm 8 Simple Orders
underlying options in AAPL, BAC,
EEM, FB, FXI, IWM, QQQ, TWTR, VXX
and XLF; 9 (iii) increase the assessment
of fees for electronic Complex Orders for
Professionals,10 Firms and BrokerDealers; 11 (iv) increase the assessment
of fees for adding liquidity in Penny
Pilot Options 12 for Specialists 13 and
Market Makers; 14 (v) clarify that the fee
for Specialists and Market Makers that
have reached their Monthly Market
the purchase or sale of options contract(s). See
Exchange Rule 1080, Commentary .08(a)(i) [sic].
6 A transaction resulting from an order that was
electronically delivered utilizes Phlx XL. See
Exchange Rules 1014 and 1080. Electronically
delivered orders do not include orders transacted
on the Exchange floor. A transaction resulting from
an order that is non-electronically-delivered is
represented on the trading floor by a floor broker.
See Exchange Rule 1063. All orders will be either
electronically or non-electronically delivered.
7 The term ‘‘Customer’’ defines a person or entity
that is neither a broker-dealer nor a direct or
indirect affiliate of a broker-dealer, and includes a
‘‘Professional’’ as defined in Rule 1000(b)(14). See
Securities Exchange Act Release Nos. 66755 (April
6, 2012), 77 FR 22037 (April 12, 2012) (SR–Phlx–
2012–42) (notice of filing and immediate
effectiveness).
8 The term ‘‘Firm’’ applies to any transaction that
is identified by a member or member organization
for clearing in the Firm range at The Options
Clearing Corporation.
9 AAPL, BAC, EEM, FB, FXI, IWM, QQQ, TWTR,
VXX and XLF are currently Penny Pilot options
(together ‘‘certain Penny Options’’). The $ 0.27 per
contract pricing proposed herein is symbol-specific
and will continue to apply to these symbols
whether or not they are deleted from or added to
the Penny Pilot.
10 The term ‘‘Professional’’ means any person or
entity that (i) is not a broker or dealer in securities,
and (ii) places more than 390 orders in listed
options per day on average during a calendar month
for its own beneficial account(s). See Rule
1000(b)(14).
11 The term ‘‘Broker-Dealer’’ applies to any
transaction which is not subject to any of the other
transaction fees applicable within a particular
category.
12 The Penny Pilot was established in January
2007 and was last extended in 2014. See Securities
Exchange Act Release Nos. 55153 (January 23,
2007), 72 FR 4553 (January 31, 2007) (SR–Phlx–
2006–74) (notice of filing and approval order
establishing Penny Pilot); and 73688 (November 25,
2014), 79 FR 71484 (December 2, 2014) (SR–Phlx–
2014–77) (notice of filing and immediate
effectiveness extending the Penny Pilot through
June 30, 2015). All Penny Pilot Options listed on
the Exchange can be found at https://
www.nasdaqtrader.com/Micro.aspx?id=phlx.
13 A Specialist is an Exchange member who is
registered as an options specialist pursuant to Rule
1020(a).
14 A ‘‘Market Maker’’ includes Registered Options
Traders (Rule 1014(b)(i) and (ii)), which includes
Streaming Quote Traders (see Rule 1014(b)(ii)(A))
and Remote Streaming Quote Traders (see Rule
1014(b)(ii)(B)). Directed Participants are also market
makers.
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13641
Maker Cap 15 in a non-complex
electronic auction will include
transactions which execute against an
order for which the Exchange broadcast
an order exposure alert; (vi) amend the
Initiating Order Fee for Simple PIXL
and Complex PIXL Initiating Orders;
and (vii) amend the requirements to
receive the PIXL Initiating Order Fee
discount to require a member or
member organization under Common
Ownership 16 to qualify for a Tier 4 or
Tier 5 Customer Rebate in Section B of
the Pricing Schedule.
The text of the proposed rule change
is available on the Exchange’s Web site
at https://
nasdaqomxphlx.cchwallstreet.com/, at
the principal office of the Exchange, and
at the Commission’s Public Reference
Room.
II. Self-Regulatory Organization’s
Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule
Change
In its filing with the Commission, the
Exchange included statements
concerning the purpose of and basis for
the proposed rule change and discussed
any comments it received on the
proposed rule change. The text of these
statements may be examined at the
places specified in Item IV below. The
Exchange has prepared summaries, set
forth in sections A, B, and C below, of
the most significant aspects of such
statements.
A. Self-Regulatory Organization’s
Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule
Change
1. Purpose
The purpose of this filing is to modify
the Pricing Schedule to specifically
amend fees in Section B, entitled
‘‘Customer Rebate Program,’’ Section II,
entitled ‘‘Multiply Listed Options Fees,’’
and Section IV, Part A, entitled ‘‘PIXL
Pricing.’’ The Exchange proposes
15 Specialists and Market Makers are subject to a
‘‘Monthly Market Maker Cap’’ of $500,000 for: (i)
Electronic and floor Option Transaction Charges;
(ii) QCC Transaction Fees (as defined in Exchange
Rule 1080(o) and Floor QCC Orders, as defined in
1064(e)); and (iii) fees related to an order or quote
that is contra to a PIXL Order or specifically
responding to a PIXL auction [sic]. The trading
activity of separate Specialist and Market Maker
member organizations is aggregated in calculating
the Monthly Market Maker Cap if there is Common
Ownership between the member organizations. All
dividend, merger, short stock interest, reversal and
conversion, jelly roll and box spread strategy
executions (as defined in Section II) are excluded
from the Monthly Market Maker Cap.
16 The term ‘‘Common Ownership’’ shall mean
members or member organizations under 75%
common ownership or control.
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]]>Agencies
[Federal Register Volume 80, Number 50 (Monday, March 16, 2015)]
[Notices]
[Pages 13639-13641]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05906]
=======================================================================
-----------------------------------------------------------------------
OFFICE OF SCIENCE AND TECHNOLOGY POLICY
Impact of the Select Agent Regulations
ACTION: Request for Public Comment.
-----------------------------------------------------------------------
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: SAReview@hq.dhs.gov. 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 SAReview@hq.dhs.gov, (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, https://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
