n1

U.S. Department of Homeland Security
Washington, DC 20528

January 7, 2015

Alison Young
Reporter
USA Today
7950 Jones Branch Drive
McLean, Virginia 22108
Sent Via Email to: ayoung@usatoday.com
RE: 2015-STFO-016
Dear Ms. Young:
This is the final electronic response to your Freedom of Information Act (FOIA) request to the
U.S. Department of Homeland Security (DHS), Science and Technology Directorate (S&T),
dated December 8, 2014. You are seeking records related to Plum Island Animal Disease Center
(PIADC) Institutional Biosafety Committee (IBC) which include the following: 1) all minutes of
the organizations IBC from January 1, 2013 to the date your request was received, and 2) all
reports of incidents (including copies of any NIH OBA report forms), accidents violations,
exposures, and potential exposures, or other issues reported under the guidelines from
January 1, 2012 to the date your request was received on December 10, 2014.
A search of S&T’s Office of National Laboratories network files for the terms IBC, meeting
minutes, and PIADC incident produced a total of 26 pages. Of those pages, I have determined
that zero pages of the records are releasable in their entirety, 26 pages are partially releasable,
and zero pages are withheld in their entirety pursuant to Title 5 U.S.C. § 552 (b)(3) Public
Health Security and Bioterrorism Preparedness and Response Act of 2002, (b)(4), (b)(5), (b)(6),
and (b)(7)(F). In regards to your request for item 2 listed above, we were unable to locate or
identify any responsive records.
Enclosed are 26 pages with certain information withheld as described below.
FOIA Exemption 3 protects information specifically exempted from disclosure by another
statute, if the statute (A) requires that the matters be withheld from the public in such a manner
as to leave no discretion on the issue, or (B) established particular criteria for withholding or
refers to particular types of matters to be withheld. See Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (P.L. 107-188) Section 212(h).

 FOIA Exemption 4 protects trade secrets and commercial or financial information obtained
from a person that is privileged or confidential. The courts have held that this subsection
protects (a) confidential commercial information, the disclosure of which is likely to cause
substantial harm to the competitive position of the person who submitted the information and (b)
information that was voluntarily submitted to the government if it is the kind of information that
the provider would not customarily make available to the public. I reviewed the responsive
documents, the submitter’s objections to release, and relevant case law, and I determined that
names of employees from private businesses are exempt from disclosure under subsection (b)(4)
of the FOIA and must be withheld in order to protect the submitter’s proprietary interests.
FOIA Exemption 5 protects from disclosure those inter- or intra-agency documents that are
normally privileged in the civil discovery context. The three most frequently invoked privileges
are the deliberative process privilege, the attorney work-product privilege, and the attorney-client
privilege. After carefully reviewing the responsive documents, I determined that portion of the
responsive documents qualify for protection under the
•

Deliberative Process Privilege
The deliberative process privilege protects the integrity of the deliberative or decisionmaking processes within the agency by exempting from mandatory disclosure opinions,
conclusions, and recommendations included within inter-agency or intra-agency
memoranda or letters. The release of this internal information would discourage the
expression of candid opinions and inhibit the free and frank exchange of information
among agency personnel.

FOIA Exemption 6 exempts from disclosure personnel or medical files and similar files the
release of which would cause a clearly unwarranted invasion of personal privacy. This requires a
balancing of the public’s right to disclosure against the individual’s right privacy. [The types of
documents and/or information that we have withheld may consist of birth certificates,
naturalization certificates, driver license, social security numbers, home addresses, dates of
birth, or various other documents and/or information belonging to a third party that are
considered personal.] The privacy interests of the individuals in the records you have requested
outweigh any minimal public interest in disclosure of the information. Any private interest you
may have in that information does not factor into the aforementioned balancing test.
FOIA Exemption 7(F) permits the government to withhold all information about any individual
when disclosure of information about him could reasonably be expected to endanger the life or
physical safety of any individual. This exemption also protects physical security at critical
infrastructure sites.
You have a right to appeal the above withholding determination. Should you wish to do so, you
must send your appeal and a copy of this letter, within 60 days of the date of this letter, to:
Associate General Counsel (General Law), Mailstop 0655, U.S. Department of Homeland
Security, Washington, DC 20528, following the procedures outlined in the DHS regulations at 6
C.F.R. § 5.9. Your envelope and letter should be marked “FOIA Appeal.” Copies of the FOIA
and DHS regulations are available at www.dhs.gov/foia.

 The Office of Government Information Services (OGIS) also mediates disputes between FOIA
requesters and Federal agencies as a non-exclusive alternative to litigation. If you are requesting
access to your own records (which is considered a Privacy Act request), you should know that
OGIS does not have the authority to handle requests made under the Privacy Act of 1974. If you
wish to contact OGIS, you may email them at ogis@nara.gov or call 1-877-684-6448.
Provisions of the FOIA [AND PRIVACY ACT] allow us to recover part of the cost of
complying with your request. In this instance, because the cost is below the $14 minimum, there
is no charge.
If you need to contact our office again about this matter, please refer to 2014-STFO-016. This
office can be reached at stfoia@hq.dhs.gov or (202) 254-6342.
Sincerely,

Katrina Hagan
FOIA Officer

Enclosures:

1) IBC Meeting Minutes, 26 pages

 U.S. Department of Homeland Security
Science and Technology Directorate
Inventory Sheet
ST FOIA 2014-STF0-016

Record Number of
Number
Pages

Title of Record

Record Date

Exemption

I

7

Plum Island Biosafety Committee Meeting Minutes

1/8/2013

3 Public Health Security and Bioterrorism
Preparedness and Response Act of2002, 4, 5, 6, 7f

2

8

Plum Island Biosafetv Committee Meeting Minutes

1127/2014

3 Public Health Security and Bioterrorism
Preparedness and Response Act of2002, 4, 5, 6, 7f

3

5

Plum Island Biosafety Committee Meeting Minutes

4/4/2014

4

6

Draft/Final Plum Island Biosafety Committee Meeting Minutes

6/20/2014

Page 1

3 Public Health Security and Bioterrorism
Preoaredness and Response Act of2002, 4, 5, 6, 7f
3 Public Health Security and Bioterrorism
Preparedness and Response Act of2002, 4, 5, 6, 7f

 1
Plum Island Biosafety Committee

January 8, 2013 Minutes

Minutes
Plum Island Biosafety Committee
Date:

January 8, 2013

Time:

9:00 am

Place:

DHS Science Conference Room, (b) (7)(F)

Recorded by: Karon Floyd
Members Present: Scott Campbell (via teleconference) Ming Deng, Geoffrey Ferman, Karon
Floyd, Bruce Harper, Christopher Schutta and William White
Members Absent: Manuel Borca

A.

New Business

A.1 Membership Update
A.1.1 Dr. Harper informed the committee that Kim Andrews of Ledyard, CT would
be the IBC’s new unaffiliated member. An updated membership roster was
provided to the committee.

A.2 Review of Annual Report
A.2.1

The committee reviewed the draft annual report and has agreed that it will
be submitted to OBA as is.

A.3 Review/Approval of Minutes from 9/24/12
A.3.1 Approved
A.4 IBC Application
A.4.1 Geoff Ferman has requested modifications to the application form. He will
make edits to the application, which will then be disseminated to the IBC for
their review at the next committee meeting.

A.5 Protocol Training
A.5.1 Dr. Harper will be requesting guidance from the SLG regarding staff listed
and projects being conducted on IBC protocols. There is some concern that
staff members may not know they are listed on protocols, may have not
completed the necessary training, all projects being captured, dual use, etc.
There was a suggestion to have a formal written statement, to be signed off
on be each staff member listed on protocols, acknowledging that they
understand their responsibilities. Additionally, there was a suggestion to
provide all staff listed on protocols the same training that the committee
receives. Dr. Harper will present the guidance received at the next committee
meeting.

B.

Review of Biosafety Applications:

B.1

Review Summary

Application
007-12-R

Application Type
Major Amendment

Outcome of Today’s Review
Approved with Comments

For Official Use Only
This document contains sensitive information exempt from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 552(b) (2)
Do not release without prior approval of the Department of Homeland Security

 Plum Island Biosafety Committee

January 8, 2013 Minutes

015-12-R

Major Amendment

Approved with Comments

021-10-P

Annual Review

Approved with Comments

022-10-R

Three Year Renewal

Approved

023-12-R

Major Amendment

Approved with Comments

024-12-R

Major Amendment

Approved with Comments

B.2
Details – Full Committee Reviews
Date:

1/8/13

Investigator:

(b) (6), (b) (7)(F)

Application #:
NIH Guideline
Section(s):
Containment Level:

007-12-R
III D-1a, III D-1b, III D-2a & III D-4b
The Board Approved agents at a BSL-2 & BSL-3.
(b) (3) (B)
(b) (3) (B)

Agent Characteristics:

(b) (3) (B)
(b) (3) (B)
(b) (3) (B)

This application plans to construct replication-(b) (3) (B), (b) (5)
Manipulations
Planned:

(b) (3) (B), (b) (5), (b) (7)(F)

Source / Nature of
inserted DNA
Sequences:
sent to
PIADC demonstrating the absence of replication competent (b) (3)
(B)

(b) (3) (B), (b) (7)(F)

Hosts and Vectors:

Action Needed: Approved with Comments
Approval
Provide more information
Item
#

Question
#

1

I – Exper
Design
III – 1c,d,e
IV-2

2
3

Pa
ge
#
3
5
6

Review by Full Committee

Suggestions / Corrections Needed

Designated Review
Corrected by
Investigator

Indicate what work will be done at BSL2 & BSL3
Update to Biosafety Level 3
(b) (6)

cannot work

For Official Use Only
This document contains sensitive information exempt from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 552(b) (2)
Do not release without prior approval of the Department of Homeland Security

Verified by
IBC
Reviewer

 Plum Island Biosafety Committee

January 8, 2013 Minutes

on the protocol until their Lab Safety Training is
completed (Min annual requirements)

Date:

1/8/13

Investigator:

(b) (6)

Application #:
NIH Guideline
Section(s):
Containment Level:
Agent Characteristics:

015-12-R
III D-1a, III D-1b, III D-2a & III D-4c
The Board Approved agents at a BSL-2 & BSL-3
(DA)
To introduce mutations and/or deletions in infectious cDNA clones in various regions of
the (b) (3) (B) genome to study the role of the viral encoded proteins in virus replication and
in virus-host interactions. (b) (3) (B), (b) (5)

(b) (3) (B)

Manipulations
Planned:

Source / Nature of
inserted DNA
Sequences:

Hosts and Vectors:

DNA Sequences will come from (b) (7)(F)
. DNA insert contains the full length or
partial sequence of (b) (3) (B) . On the 5' end of the construct a T7 polymerase promoter has
been added to enable in vitro transcription of the construct. (b) (3) (B), (b) (7)(F)

E.coli (DH5alpha/top10), Plasmids (pRMC35, pLLV2, pA24Cru, (b) (3) (B)
(b) (3) (B)

Approval
Provide more information
Action Needed: Approved with Comments
Approval
Provide more information
Pa
ge
#
3

Item
#

Question
#

1

I – Exper
Design

2

I – Exper
Design

3

3

IV-2

6

Review by Full Committee

Designated Review

Review by Full Committee

Designated Review

Suggestions / Corrections Needed

Corrected by
Investigator

Indicate what work will be conducted at BSL2, if
any. If no work is to be conducted in BSL2, unselect the check box on the top of page 5.
Add explination of (b) (3) (B) Replicon work to be
conduct (and where it will be conducted)
(b) (6), (b) (7)(F)
cannot work
on the protocol until their Lab Safety Training is
completed (Min annual requirements)

Date:

1/9/13

Investigator:

(b) (6)

Application #:

021-10-P

Application Date:
NIH Guideline
Section(s):

12/27/12
III D-2a & III-F-6

For Official Use Only
This document contains sensitive information exempt from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 552(b) (2)
Do not release without prior approval of the Department of Homeland Security

Verified by
IBC
Reviewer

 Plum Island Biosafety Committee

Containment Level:

January 8, 2013 Minutes

The Board Approved agents at a BSL-3 Level.
(b) (3) (B)

Agent Characteristics:
This application plans to routinely characterize animal disease agents and experimentally
derived cDNAs, plasmids or DNA from diagnostic or research investigations at (b) (7)(F)
(b) (5)

Manipulations
Planned:

in accordance
with standard USDA and PIADC Safety Office procedures and approvals.
Source / Nature of
inserted DNA
Sequences:
Hosts and Vectors:

(b) (3) (B)

and other
Eukaryotic, prokaryotic, viral organisms, RNA or DNA.
E coli K 12 Host Vector Systems to be used (K 12 derived commercial strains – HB101,
DH5a, JM109 and TOP 10). Bacterial plasmids pBR322 or PUC derived vector plasmids
and bacteriophage.

(b) (3) (B)

Action Needed: Minor Changes
Approval
Provide more information
Item
#

Question
#

1
2

III – 1,c
III – 1, f

Pa
ge
#
6
6

Review by Full Committee

Suggestions / Corrections Needed

Designated Review
Corrected by
Investigator

should be listed as BSL 3
should be listed as BSL 3
(b) (6), (b) (7)(F)

3

Date:

IV-2

7

(b) (6), (b) (7)(F)

have not yet completed the necessary
training modules.

(b) (6), (b)
(7)(F)

9/24/12

Investigator:
Application #:

022-10-R

For Official Use Only
This document contains sensitive information exempt from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 552(b) (2)
Do not release without prior approval of the Department of Homeland Security

Verified by
IBC
Reviewer

 Plum Island Biosafety Committee

Application Date:
NIH Guideline
Section(s):
Containment Level:
Agent Characteristics:
Manipulations
Planned:
Source / Nature of
inserted DNA
Sequences:
Hosts and Vectors:

January 8, 2013 Minutes

8/13/12
III D-1b, III D-2a & III D-4b
The Board Approved agents at a BSL-3 Level.
(b) (3) (B)

This project has two main objectives: (i) develop by genetic manipulation (b) (3) strains
that can be used as live attenuated vaccines, and (ii) test the hypothesis that(B)isolated viral
proteins can be used as experimental immunogen against (b) (3) infection.
(B)

(b) (3) (B), (b) (7)(F)

Bacterial Plasmid – pAYC177, pdIIIGFP (b) (3) (B)
Cell Cultures (LFBK, SK6, PBNC); (b) (7)(F)

E-coli DH5; Primary
E-coli (K-12); (b) (3) (B)

(b) (3) (B)

Action Needed: Approved
Approval
Provide more information
1/8/13
Date:
Investigator:

(b) (6)

Application #:

023-12-R

Application Date:
NIH Guideline
Section(s):
Containment Level:

11/26/12

Agent Characteristics:

Review by Full Committee

Designated Review

III-D-1a, III-D-1b, III-D-2a, III-D-4b & III-F
The Board Approved agents at a BSL-3 Level.
E.coli (DH5 derivative competent cell)
HEK293 (Transformed human cell line)
LFBK (Established bovine cell line)
(b) (3) (B), (b) (7)(F)

This application plans to design a leading peptide sequence based on bovine secretory
(b) (3) (B), (b) (5)

Manipulations
Planned:

E.coli will be received from commercial vendor. HEK293 & LFBK will be provided by
will be obtained from (b) (3) (B), (b) (6)

Source / Nature of
inserted DNA
Sequences:

(b) (6), (b) (7)(F)

Hosts and Vectors:

pUC57C, pMV-HA, pCEP4, e.coli (NEB
Competent), Tissue cultures (established and transformed cell lines).

(b) (6)

For Official Use Only
This document contains sensitive information exempt from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 552(b) (2)
Do not release without prior approval of the Department of Homeland Security

 Plum Island Biosafety Committee

January 8, 2013 Minutes

Action Needed: Approved with Comments
Approval
Provide more information
Review by Full Committee
Pa
Item
Question
ge
Suggestions / Corrections Needed
#
#
#
1
II – 5
6
Indicate if you will be performing work within
BSL-2

Date:

1/8/13

Investigator:

(b) (6)

Application #:

024-12-R

Application Date:
NIH Guideline
Section(s):
Containment Level:

11/26/12

Agent Characteristics:

Designated Review
Verified by
Corrected by
IBC
Investigator
Reviewer

III-D-1a, III-D-1b, III-D-2a, III-D-4b & III-F
The Board Approved agents at a BSL-3 Level.
E.coli (DH10B derivative competent cell)
HEK293 (Transformed human cell line)
LFBK (Established bovine cell line)
(b)
(B)
(b) (3)
(7)(F)

use five additional approaches to increase the efficacy of IFN biotherapeutics including
(b) (3) (B), (b) (5)

Manipulations
Planned:

a. The competent E. coli will be provided by New England Biolabs
b. HEK293 and LFBK are provided by (b) (6)
c. (b) (7)(F)
d. (b) (4), (b) (7)(F)
e. (b) (6), (b) (7)(F)
Adenovirus (human Ad5 with E1/E3 deletion), pUC57C, pcDNA3, pCEP4, e.coli (NEB
Hosts and Vectors:
Competent), Tissue cultures (established and transformed cell lines).
Action Needed: Approved with Comments
Approval
Provide more information
Review by Full Committee
Designated Review
Pa
Verified by
Item
Question
Corrected by
ge
Suggestions / Corrections Needed
IBC
#
#
Investigator
#
Reviewer
1
II – 5
6
Indicate if you will be performing work within
Source / Nature of
inserted DNA
Sequences:

For Official Use Only
This document contains sensitive information exempt from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 552(b) (2)
Do not release without prior approval of the Department of Homeland Security

 Plum Island Biosafety Committee

2

C.

III – 1,d

6

January 8, 2013 Minutes

BSL-2
Change IBRS-2 to BSL-3

Old Business

C.1 FMDV Acetone Inactivation
C.1.1 This project is no longer specific to (b) (3) (B)

. The
exemption of acetone fixed intermediate tissues is a more accurate
descriptor. The committee reviewed the results that (b) (6)
has provided
and at this point it was determined that this information should be referred to
the Select Agent Program, through (b) (6)
for further guidance.

Meeting Adjourned 10:45am

For Official Use Only
This document contains sensitive information exempt from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 552(b) (2)
Do not release without prior approval of the Department of Homeland Security

 2

Minutes
Plum Island Biosafety Committee
Date:

27 January 2014

Time:

9:00 am

Place:

DHS Science Conference Room, (b) (7)(F)

Recorded by: Kris Dooley, Thamus Morgan
Members Present: Geoffrey Ferman, Karon Floyd, Bruce Harper, Chris Schutta, and William
White
Members Absent: Scott Campbell and Ming Ding

A.

New Business

A.1 Introduction of Dr Morgan replacing Ms Kris Dooley
A.1.1 The IBC welcomed Dr Thamus Morgan
A.2 Review/Approval of Minutes from 12/12/2013
A.2.1 Approved as submitted
A.3 Review of IBC Charter
A.3.1

Ms. Floyd will provide modifications necessary based on updated NIH
Guidelines where the select agent regulations or the NIH guidelines refer to
the less than 75 % genome rule. The IBC charter should reflect the same
language of whichever document the reference appears in

A.4 Recommendation of AALAS training module as IBC annual training requirement
A.4.1 Recommendation of an AALAS Animal Biosafety Training Program module
to be used as the annual IBC continuing education module. Title of module
is: Institutional Responsibilities and Animal Biosafety. This training was
approved by the group.

A.4.2 All IBC members already have an account with the AALAS Library (Ms.
Kris Dooley – PIADC Administrator)

B.

Review of Biosafety Applications:

B.1

Review Summary

Application
016-12-R

Application Type
Major Amendment

Outcome of Today’s Review
Deferred

023-12-R

Annual Review

Approved

024-12-R

Annual Review

Approved

027-13-R

New Protocol

Deferred

B.2
Details – Full Committee Reviews
Date:

27 January 2014

1

 Investigator:

(b) (6), (b) (7)(F)

Application #:
NIH Guideline
Section(s):
Containment Level:
Agent Characteristics:

016-12-R
III D-1a, III D-1b, III D-2a & III D-4b
The Board Approved agents at a BSL-2 & BSL-3
(b) (3) (B)

Expression vectors containing (b) (3) (B) proteins will be generated by standard PCR and
cloning techniques and utilized for in-vitro studies to determine interactions with host
factors involved in viral pathogenesis. (b) (3) (B), (b) (5)

Manipulations
Planned:

DNA Sequences will come from (b) (3) (B), (b) (6), (b) (7)(F)
Source / Nature of
inserted DNA
Sequences:

Hosts and Vectors:
Approval
Item
#

Question
#

, Bacterial Plasmids (pBR322), E.coli (nonpathogenic) and

(b) (3) (B)

Tissue Cultures.
Provide more information
Pa
ge
#

Review by Full Committee

Suggestions / Corrections Needed

Designated Review
Corrected by
Investigator

Verified by
IBC
Reviewer

submitted an amendment
referencing the use of a bioreactor. The committee
decided to not approve the amendment as a more
in-depth review is necessary by the IBC and the
Safety Office.

(b) (6), (b) (7)(F)

1

Date:

27 January 2014

Investigator:

(b) (6), (b) (7)
(F)

Application #:
NIH Guideline
Section(s):
Containment Level:

023-12-R

Agent Characteristics:

III D-2a & III F-6
BSL-3
E. coli DH5a derivative competent cell; HEK293 transformed human cell line;
(b) (3) (B), (b) (7)(F)
LFBK established bovine cell line;
replication-defective;(b) (3) (B)
1. (b) (3) (B), (b) (5)

Manipulations
Planned:

2

 (b) (5)

2.

(b) (3) (B), (b) (5)

3. To enhance host response to vaccination, host cytokines and chemokine
genes will be selected based on reported functions and inserted into the
(b) (5) vector. The expression in cell culture will be tested using Western
blotting.
(b) (5), (b) (7)(F)

Source / Nature of
inserted DNA
Sequences:

Hosts and Vectors:
Approval

a. E. coli will be provided by New England Biolabs (1-800-632-5227)
b. (b) (6), (b) (7)(F)
c. (b) (6), (b) (7)(F)
d. (b) (3) (B), (b) (6), (b) (7)(F)
Vector: human Ad5 with the E1 and E2 deletion; plasmid: : pUC57C
(Genscript), pcDNA3.1 and pCEP4 (Invitrogen) Host: E. coli: Name
derivative or strain: NEB 5-alpha competent E. coli (Cat#C29871 K-12 Strain)
(New England Biolabs)
Provide more information
Review by Full Committee
Designated Review

Item
#

Question
#

Pa
ge
#

1

II

5

2

Suggestions / Corrections Needed

Corrected by
Investigator

Verified by
IBC
Reviewer

Please indicate that
is not a select
agent
What are your hazardous materials?

3

 3

IV

6

Please make a list of virues to be used as
antigen

4

V

8

Please update training dates

5

VI

Please add the person you talked to as an
industrial hygienist and the date of the
conversation
Geoff Ferman is your designated reviewer.
Once you complete the above items and
consulted with Geoff Ferman, an approval
letter will follow.

9

6

Date:

27 January 2014

Investigator:

(b) (6)

Application #:

024-12-R

Application Date:
NIH Guideline
Section(s):
Containment Level:

13 February 2012

Agent Characteristics:

III D-1a, III D-1b, III D-2a, III D-4b, Other: III F
BSL-3
E. coli NEB 5-alpha competent E. coli; HEK293 transformed human cell line
LFBK established bovine cell line; IBRS-2 established porcine cell
Recombinant (b) (3) (B)
type 5, replication-defective;(b) (3) (B)
1. DNA shuffling technique described by Stemmer (Proc. Natl. Acad. Sci.
1994, 91:10747-10751) has been successfully used to create new IFN
genes with significantly increased antiviral activity (Brideau-Andersen et
al., Proc. Natl. Acad. Sci. 2007, 20:8269-8274). New bovine type I IFN
(IFNA) genes will be created from all bovine type I
(b) (3) (B), (b) (5)

2.

(b) (5)

3.

(b) (5)

4.

(b) (5)

Manipulations
Planned:

4

 (b) (5)

5.

6.

(b) (5)

(b) (5)

7.

(b) (5), (b) (6)

8.

(b) (3) (B), (b) (5)

9.

(b) (5), (b) (7)(F)

a.

(b) (5), (b) (7)(F)

b.
Source / Nature of
inserted DNA
Sequences:

c.
d.

e.

f.

5

 (b) (5), (b) (7)(F)

g.

h.
i.

j.
Source: The competent E. coli will be provided by (b) (4)
(b) (5), (b) (6)

HEK293, LFBK, and IBRS-2 will be provided (b) (6), (b) (7)(F)

E. coli NEB Competent E. coli (DH10B, k-12 strain) (b) (6), (b) (7)(F)
Hosts and Vectors:

Approval

:

all viral protein genes deleted; plasmids pUC57C (Genscript), pMV-HA
(Clontech), pcDNA3.1 (Invitrogen) and pCEP4 (Invitrogen)
Provide more information

Item
#

Question
#

1

V

Pa
ge
#
7

2

II

3

3

IV

6

4

Review by Full Committee

Suggestions / Corrections Needed

Designated Review
Corrected by
Investigator

Verified by
IBC
Reviewer

Please update training dates.
Please note that
is not a select
agent.
Please remove check box for the adequate
surveillance program at PIADC
Please return answers to Dr Borca, as he has
been assigned you designated reviewer

Date:

27 January 2014

Investigator:

(b) (6)

Application #:
NIH Guideline
Section(s):
Containment Level:
Agent Characteristics:

XXX-13-R
III D-1a, III D-2a, III D-4b
BSL-3
(b) (3) (B), (b) (7)(F)

Using genetic engineering and reverse genetics, we have assembled a series of DNA
plasmids containing (b) (3) (B)
which can be used to systematically evaluate the role
of specific viral proteins or sequence domains involved with (b) (3) virulence and to
(B)
engineer attenuated marker (b) (3) (B), (b) (5)

Manipulations
Planned:

6

 (b) (3) (B), (b) (5)

(b) (3) (B), (b) (4), (b) (5), (b)
(6)

Source / Nature of
inserted DNA
Sequences:

Hosts and Vectors:
Approval

Host: (b) (6)
Shot TOP10; (b) (3) (B)
Provide more information

Item
#

Question
#

1

II
II

Pa
ge
#
4
4

II

4

II-3

4

III-2
III- 4
V-2

6
6
7

V-1
VI - 1

7
8

et a; Plasmid: Zero Blunt TOPO, pTIT and pLC; Host-E. coli-One
Review by Full Committee

Suggestions / Corrections Needed

Designated Review
Corrected by
Investigator

Verified by
IBC
Reviewer

(b) (5), (b) (6), (b) (3) (B)

2

3
4
5
6
7
8

9

7

 10

C.

other

-

Please work with Geoff Ferman on(b) (3) (B)
(b) (3) (B)

Training

C.1 None occurred
Meeting Adjourned 10:45am

8

 3

Minutes
Plum Island Biosafety Committee
Date:

4 April 2014

Time:

9:00 am

Place:

DHS Science Conference Room, (b) (7)(F)

Recorded by: Kathy White / Karon Floyd
Members Present: Geoffrey Ferman, Karon Floyd, Chris Schutta, Ming Deng, Kim Andrews
and William White
Members Absent: Scott Campbell and Bruce Harper

A.

New Business

A.1 Introduction of Dr. Karon Floyd replacing Dr. Bruce Harper
A.1.1 The IBC welcomed Dr. Karon Floyd as Chair
A.2 Review/Approval of Minutes from 01/08/2014
A.2.1 Reviewed, 2 changes made and approved
A.3 Review of IBC Charter
A.3.1

Ms. Floyd provided modifications necessary based on updated NIH
Guidelines; however, the IBC Charter will be revised again. Ms. Floyd
requested guidance from Committee to either approve Charter as presently
written or wait until all changes have been made – Committee voted to table
Charter review until all changes have been made.

A.4 Animal trailer decontamination SOPs / Animal deliveries
A.4.1 A PIADC animal transport trailer needs to be replaced.
A.4.2 In accordance with the Animal Welfare Act 9 CFR part 3 (subpart F)
“…animals must be maintained above 45 degrees Fahrenheit for transport…”

A.4.3 In accordance with best practices of biosecurity, two trailers are needed to
ensure there is no cross contamination coming onto or going off the Island
when transporting animals.

A.4.4 The present SOPs (DHS & Primus) for animal trailer decontamination are
adequate.

A.5 Personal Recognizant Quarantine
A.5.1 Discussion of PRQ and the ownership of birds & rabbits
A.5.2 Group decided more discussion was needed, to include input of the Senior
Leadership Group

A.5.3 Awaiting SLG feedback
A.6 Use of Contact lens within biocontainment
A.6.1 Current policy – “contact lenses not allowed in biocontainment (B101 /
B102)

v.6

1

 A.6.2 BMBL recommendations “…use of contact lenses with appropriate eye
protection…”

A.6.3 Discussion of group
? Allow contact usage within (b) (7)(F)
(b) (7)(F)

? Allow contact lens usage within (b) (7)(F)

– laboratories
and animal containment areas, and necropsy with appropriate eye
protection .

A.7 Usage of FitBit Flex wrist band
A.7.1 Employee owned, waterproof design, device is an exercise-sleep monitor
used in weight reduction programs.

A.7.2 Not an essential piece of equipment required for employment
A.7.3 Request not approved.
A.8 Recommendation of AALAS training module as IBC annual training requirement
A.8.1 Approved.
B.

Review of Biosafety Applications:

B.1

Review Summary

Application
016-12-R

Application Type
Major Amendment

Outcome of Today’s Review
Approved

015-12-R

Annual Review

Approved

003-12-R

Annual Review

Approved

027-13-R

New Protocol

Approved

028-14-D

New Protocol

Approved with Comment

007-12-R

Annual Renewal

Approved

014-12-R

Annual Review

Approved

022-13-R

Annual Review

Approved

B.2
Details – Full Committee Reviews
Date:

27 January 2014

Investigator:

(b) (7)(F), (b) (6)

Application #:
NIH Guideline
Section(s):
Containment Level:
Agent Characteristics:

016-12-R
III D-1a, III D-1b, III D-2a & III D-4b
The Board Approved agents at a BSL-2 & BSL-3
(b) (3) (B)
(b) (5), (b) (3) (B)

Manipulations
Planned:

v.6

2

 The goal of these
studies is to understand the interaction of viral and host proteins and the role
of these interactions in the pathogenesis of

(b) (3) (B), (b) (5)

(b) (3) (B), (b) (5)

(b) (5), (b) (3) (B)

renilla luciferase: Renilla reniformis (Sea
Pansy) and Renilla mullerei (Gulf of Mexico) are species of soft coral; green
fluorescent protein: jellyfish Aequorea victoria.

(b) (3) (B)

Source / Nature of
inserted DNA
Sequences:

Hosts and Vectors:
X Approval
Item
#

a. (b) (6), (b) (7)(F)
b. (b) (6), (b) (7)(F)

, Bacterial Plasmids (pBR322), E.coli (nonpathogenic) and

(b) (3) (B)

Tissue Cultures.
Provide more information

Question
#

Pa
ge
#

Review by Full Committee

Suggestions / Corrections Needed

Designated Review
Corrected by
Investigator

Verified by
IBC
Reviewer

Date:

3 April 2014

Investigator:

(b) (6), (b) (7)(F)

Application #:

028-14-D

Containment Level:

BSL-3
Chlorine Dioxide and Vaporous Hydrogen Peroxide Decontamination Study with
Foreign Animal Disease Viruses

Agent Characteristics:

(b) (3) (B), (b) (5)

Manipulations
Planned:

v.6

3

 (b) (3) (B), (b) (5)

Source / Nature of
inserted DNA
Sequences:
Approval

1. PIADC

(b) (6), (b) (7)(F)

2. N/A Biological Material
Provide more information

Item
#

Question
#

1

III.1

Pa
ge
#
6

2

IV.1

7

Review by Full Committee

Suggestions / Corrections Needed
Add Agent for biological indicator
Check yes to will you be working with
infectious micro-organisms and/or
human/primate cell lines

Date:

27 January 2014

Investigator:

(b) (6), (b) (7)(F)

Application #:
NIH Guideline
Section(s):
Containment Level:
Agent Characteristics:

027-13-R

Designated Review
Corrected by
Investigator

Verified by
IBC
Reviewer

X
X

III D-1a, III D-2a, III D-4b
BSL-3
(b) (7)(B)
(b) (3) (B), (b) (5)

Manipulations
Planned:

The goal of these studies is to understand the viral and host factors determining (b) (5)
, such as the role of specific viral proteins and the interaction of

(b) (5)

v.6

4

 viral and host proteins and the role of these interactions in the pathogenesis of (b) (5)
(b) (5), (b) (7)(F)

E. Coli attenuated laboratory strains sold from (b) (4)
TOP10 Chemically Competent E. coli. These commerically available bacteria

(b) (3) (B), (b) (5)

Source / Nature of
inserted DNA
Sequences:

(b) (5)

Hosts and Vectors:
X Approval

C.

Host: (b) (3) (B), (b) (7)(F)
: Zero Blunt TOPO, pTIT and pLC; Host-E. coli-One
Shot TOP10; pig (Sus scroffa) and cattle (Bos taurus)
Provide more information
Review by Full Committee Designated Review

Training
C.1 Handouts were provided by Ms. Floyd for training. Due to time constraints, training
will be sent to IBC Membership

Meeting Adjourned 11:00 am

v.6

5

 4

Minutes
Plum Island Biosafety Committee
Date:

20 June 2014

Time:

9:00 am

Place:

(b) (7)(F)

Recorded by: Thamus J Morgan DVM, MPH
Members Present: Geoffrey Ferman, Karon Floyd, Chris Schutta, Fawzi Mohammed, Manuel
Borca, Jennifer Smoliga, and William White
Members Absent: Scott Campbell, Kim Andrews, Ming Deng

A.

New Business

A.1 Change to IBC application form
A.1.1 Section V Personnel
? Strike “Contact the Biosafety Officer if you have questions at (b) (6)
(b) (6) or (b) (6)

? The current Biosafety Officer does not oversee present laboratory training
of personnel.

? This change will be applied to each new application and review forward.
A.1.2 Approved by committee
A.2 Review / Approval of Minutes from 4 April 2014
A.2.1 Reviewed, 3 changes made and approved
? Section A.5.3 Awaiting SLG decision
? Section A.6.3 Contact lens can be worn in Zones 2, 3, & 4 provided that
appropriate eye protection is also worn.

? Section A.7.3 Request (to wear Fitbit) was not approved.
B.

Review of Biosafety Applications:

B.1

v.2

Review Summary

Application
012-12-D

Application Type
Major Amendment

Outcome of Today’s Review
Approved

013-12-R

Annual Review

Approved

025-12-D

Annual Review

Approved

6.25.2014

1

 B.2
Details – Full Committee Review
Date:

20 June 2014

Investigator:

(b) (6), (b) (7)(F)

Application #:
NIH Guideline
Section(s):
Containment Level:
Agent Characteristics:

012-12-D
III D-1a, III D-2a, & III D-4a
BSL-3
(b) (3) (B)

•Experimental Design
(b) (3) (B), (b) (5)

Manipulations
Planned:
•Personal Protective Equipment and Biosafety
(b) (3) (B), (b) (5)

Source / Nature of
inserted DNA
Sequences:

Source :
a. USDA - APHIS - ARS
b. (b) (4)
c. Any commercial vendor providing DNA oligonucleotide synthesis services
Nature :
(b) (3) (B)

Host:

E. coli:

Name derivative or strain: K12

Vectors:
(b) (3) (B)

Hosts and Vectors:
(b) (3) (B)

v.2

6.25.2014

2

 (b) (3) (B)

(b) (3) (B)

X Approval
Item
#
1
2

Provide more information

N/A

Pa
ge
#
3

N/A

3

Sec IV.6

6

Question
#

3

C.

Review by Full Committee

Suggestions / Corrections Needed
Change face shield use to prevent splatter rather
than aerosol inhalation protection
Change BSL2 biosafety cabinet to BSL3, Class II
biosafety cabinet
Change “…aerosol containment capsules for BSL3
containment” to “…aerosol containment rotors and
cups”

Designated Review
Corrected by
Investigator

Verified by
IBC
Reviewer

X

X

X

X

X

X

Training
C.1 No training this meeting

Meeting Adjourned at 9:30 am

v.2

6.25.2014

3

 Minutes

Plum Island Biosafety Committee

Date: 20 June 20l4
Time: 9:00 am
Place: (WMF)

Recorded by: Thamus Morgan DVM, MPH

Members Present: Geoffrey Ferman, Karon Floyd, Chris Schutta, Fawzi Mohammed, Manuel
Borca, Jennifer Smoliga, and William White

Members Absent: Scott Campbell, Kim Andrews, Ming Deng
A. New Business
A.1 Change to application form

A.l.l Section Personnel

0 Strike ?Contact the Biosafct Of?cer if ou have questions (0)

0 The current Biosafety Of?cer does not oversee present laboratory training
of personnel.

0 This change will be applied to each new application and review forward.
A.l.2 Approved by committee
A.2 Review Approval of Minutes from 4 April 2014



A.2.1 Reviewed. 3 changes made and approved

0 Section A.5.3 Awaiting SLG decision concerning the PRQ and the
ownership of rabbits birds by employees

0 Section A.6.3 Contact lens can be worn in Zones 2, 3. 4 provided that
appropriate protection is also worn.

0 Section A.7.3 Request (to wear Fitbit) was not approved.

B. Review of Biosafety Applications:

Review Summary











Application Application Type Outcome of Today?s Review
012-12-D Major Amendment Approved
Annual Review Approved
025-12-D Annual Review Approved









v.2 6.25.2014

8.2

Details - Full Committee Review

Date:

20 June 20 I4



lnvestiga tor:



(5). (D)



Application





NIH Guideline
Section(s):

[ll D-la. 0-221. 8; [ll D-4a



Containment Level:





Agent Characteristics:







Manipulations
Planned:



'Personal Protective Equipment and Biosal?ety

PPF. for persons working in the animal rooms will include disposable 'l?yvek suits and
gloves. Gloves will be taped when evidence oi?an active secondary infection is seen
within the herd. such as ringworm or pustular stomatitis. l-?ace shields will be worn
duringhallengc inoculation to protect against splash splatter to face. All
individuals will be required to shower-out prior to exiting the animal room. In the
laboratory. all samples collected from the animal wings will be treated as potentially
infectious and will be processed inside a BSL3 Class ll biosafety cabinet. Disposable
tubes and plasticware will be used to process clinical samples and all waste will be steam
autoclaved under high pressure for 45 minutes prior to collection for disposal. Sharps
will be disposed of in an approved sharps container.



Source Nature of
inserted DNA
Sequences:

Source
a. USDA - APHIS - ARS

c. Any commercial vendor providind DNA oliqonucleotide services
Nature







Hosts and Vectors:



Host: E15 edit Name derivative or strain:

ectors:

Adenovirus human Aditproprietarv)

ls thisstrain replicative defective? Yes 0V0

Adenovirus Name strain and describe wild type deletions: human Adl4
(proprietao)
ls thisstrain replicative defective?



Yes (No

(5.25.2014

Name strain and describe wild type deEtions: (D) (3)







is this strain replicative defective? Yes
1 Al ha-Virus like particles Name strain and describe wild tvpe deletions:
mety capsids(proprictary)





Approval Provide more information Review by Full Committee Designated Review



















ltct?t l)tt3stun (?turret'tui in L?mwd h}
ue onx .
.
l<e\
1 3 Change face shield use to prevent splatter rather
than aerosol inhalation protection
3 Change BSLZ biosafety cabinet to BSL3, Class II
2 biosafety cabinet
Sec lV.6 6 Change containment capsules for BSL3
3 containment" to  . .aerosol containment rotors and
cupS?

C. Training

No training this meeting

Mccting Adjourned at 9:30 am

v.2 6.25.2014



U.S. Department of Homeland Security
Washington, DC 20528

February 19, 2015

Alison Young
Reporter
USA Today
7950 Jones Branch Drive
McLean, Virginia 22108
Sent Via Email to: ayoung@usatoday.com
RE: 2015-STFO-016
Dear Ms. Young:
This letter is in response to your email dated January 21, 2014 in which you expressed your
concerns regarding the Department of Homeland Security Science and Technology Directorates
final response. You specifically requested S&T to re-examine the approach taken in making final
determinations and the use of FOIA exemption (b)(3), specifically the Bioterrorism Act of 2002.
In your December 8, 2014 you sought records related to Plum Island Animal Disease Center
(PIADC) Institutional Biosafety Committee (IBC) which include the following: 1) all minutes of
the organizations IBC from January 1, 2013 to the date your request was received, and 2) all
reports of incidents (including copies of any NIH OBA report forms), accidents violations,
exposures, and potential exposures, or other issues reported under the guidelines from
January 1, 2012 to the date your request was received on December 10, 2014.
This office exercised discretionary release of information as directed in Attorney General
Holder’s FOIA guidelines issued on March 19, 2009. See
http://www.justice.gov/sites/default/files/oip/legacy/2014/07/23/foia-memorandum.pdf. In our
final response dated January 7, 2015, we asserted FOIA exemptions 3,4,5,6, and 7f. After
further review of these records, we have determined that our withholding of information pursuant
to FOIA exemption (b)(3) Public Health Security and Bioterrorism Preparedness and Response
Act of 2002 also known as the Bioterrorism Act was asserted in error. We have also determined
that portions of the information previously withheld pursuant to FOIA exemption 3, will
continue to be withheld pursuant to FOIA exemption 5 for the reasons cited below.

 Enclosed are 26 updated pages with certain information withheld under the assertion of FOIA
exemption 4, 5, 6 and 7f.
FOIA Exemption 4 protects trade secrets and commercial or financial information obtained
from a person that is privileged or confidential. The courts have held that this subsection
protects (a) confidential commercial information, the disclosure of which is likely to cause
substantial harm to the competitive position of the person who submitted the information and (b)
information that was voluntarily submitted to the government if it is the kind of information that
the provider would not customarily make available to the public. I reviewed the responsive
documents, the submitter’s objections to release, and relevant case law, and I determined that
names of employees from private businesses are exempt from disclosure under subsection (b)(4)
of the FOIA and must be withheld in order to protect the submitter’s proprietary interests.
FOIA Exemption 5 protects from disclosure those inter- or intra-agency documents that are
normally privileged in the civil discovery context. The three most frequently invoked privileges
are the deliberative process privilege, the attorney work-product privilege, and the attorney-client
privilege. After carefully reviewing the responsive documents, I determined that portion of the
responsive documents qualify for protection under the
•

Deliberative Process Privilege
The deliberative process privilege protects the integrity of the deliberative or decisionmaking processes within the agency by exempting from mandatory disclosure opinions,
conclusions, and recommendations included within inter-agency or intra-agency
memoranda or letters. The release of this internal information would discourage the
expression of candid opinions and inhibit the free and frank exchange of information
among agency personnel.

The redacted information is interexicably intertwined with deliberative information involved
with the policy-making process. See Ryan v. Department of Justice, 617 F.2d 781, 790 (D.C.
Cir. 1980). All non-exempt portions of the records that are not inextricably intertwined with
exempt portions were provided to you. See Mead Data Cent., Inc. v. United States Dep't of the
Air Force, 566 F.2d 242, 260 (D.C. Cir. 1977). The release of this information would cause
foreseeable harm by revealing detailed recommendations for future and developing plans or
alternative avenues for potential strain and vector constructions. The release of this information
would prematurely reveal the details of recommended strain and vector construction for the
development of potential vaccines and other countermeasures which would compromise future
intellectual property rights.
FOIA Exemption 6 exempts from disclosure personnel or medical files and similar files the
release of which would cause a clearly unwarranted invasion of personal privacy. This requires a
balancing of the public’s right to disclosure against the individual’s right privacy. [The types of
documents and/or information that we have withheld may consist of birth certificates,
naturalization certificates, driver license, social security numbers, home addresses, dates of
birth, or various other documents and/or information belonging to a third party that are
considered personal.] The privacy interests of the individuals in the records you have requested
outweigh any minimal public interest in disclosure of the information. Any private interest you
may have in that information does not factor into the aforementioned balancing test.

 FOIA Exemption 7(F) permits the government to withhold all information about any individual
when disclosure of information about him could reasonably be expected to endanger the life or
physical safety of any individual. This exemption also protects physical security at critical
infrastructure sites.
You have a right to appeal the above withholding determination. Should you wish to do so, you
must send your appeal and a copy of this letter, within 60 days of the date of this letter, to:
Associate General Counsel (General Law), Mailstop 0655, U.S. Department of Homeland
Security, Washington, DC 20528, following the procedures outlined in the DHS regulations at 6
C.F.R. § 5.9. Your envelope and letter should be marked “FOIA Appeal.” Copies of the FOIA
and DHS regulations are available at www.dhs.gov/foia.
The Office of Government Information Services (OGIS) also mediates disputes between FOIA
requesters and Federal agencies as a non-exclusive alternative to litigation. If you are requesting
access to your own records (which is considered a Privacy Act request), you should know that
OGIS does not have the authority to handle requests made under the Privacy Act of 1974. If you
wish to contact OGIS, you may email them at ogis@nara.gov or call 1-877-684-6448.
Provisions of the FOIA [AND PRIVACY ACT] allow us to recover part of the cost of
complying with your request. In this instance, because the cost is below the $14 minimum, there
is no charge.
If you need to contact our office again about this matter, please refer to 2014-STFO-016. This
office can be reached at stfoia@hq.dhs.gov or (202) 254-6342.
Sincerely,

Katrina Hagan
FOIA Officer

Enclosures:

1) IBC Meeting Minutes, 26 pages

 Plum Island Biosafety Committee

January 8, 2013 Minutes

Minutes
Plum Island Biosafety Committee
Date:

January 8, 2013

Time:

9:00 am

Place:

DHS Science Conference Room, (b) (7)(F)

Recorded by: Karon Floyd
Members Present: Scott Campbell (via teleconference) Ming Deng, Geoffrey Ferman, Karon
Floyd, Bruce Harper, Christopher Schutta and William White
Members Absent: Manuel Borca

A.

New Business

A.1 Membership Update
A.1.1 Dr. Harper informed the committee that Kim Andrews of Ledyard, CT would
be the IBC’s new unaffiliated member. An updated membership roster was
provided to the committee.

A.2 Review of Annual Report
A.2.1

The committee reviewed the draft annual report and has agreed that it will
be submitted to OBA as is.

A.3 Review/Approval of Minutes from 9/24/12
A.3.1 Approved
A.4 IBC Application
A.4.1 Geoff Ferman has requested modifications to the application form. He will
make edits to the application, which will then be disseminated to the IBC for
their review at the next committee meeting.

A.5 Protocol Training
A.5.1 Dr. Harper will be requesting guidance from the SLG regarding staff listed
and projects being conducted on IBC protocols. There is some concern that
staff members may not know they are listed on protocols, may have not
completed the necessary training, all projects being captured, dual use, etc.
There was a suggestion to have a formal written statement, to be signed off
on be each staff member listed on protocols, acknowledging that they
understand their responsibilities. Additionally, there was a suggestion to
provide all staff listed on protocols the same training that the committee
receives. Dr. Harper will present the guidance received at the next committee
meeting.

B.

Review of Biosafety Applications:

B.1

Review Summary

Application
007-12-R

Application Type
Major Amendment

Outcome of Today’s Review
Approved with Comments

For Official Use Only
This document contains sensitive information exempt from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 552(b) (2)
Do not release without prior approval of the Department of Homeland Security

 Plum Island Biosafety Committee January 8. 2013 Minutes































015-12-R Major Amendment Approved with ormnents
021-10-P Annual Review Approved with Comments
022-10-R Three Year Renewal Approved
023-12-R Major Amendment Approved with Comments
024-12-R Major Amendment Approved with Comments
B.2
Details Full Committee Reviews

Date: 1 8/ 1 3

Investigator: mm

Application

NIH Guideline

- - -7
Section?): 1a. HID lb. -a D-4b



Containment Level: The Board Approved agents at a BSL-2 BSL-S.









Human Adenovirus
FMDV
Agent Characteristics: VSV (111 rana. ew ersey
Poxvirus (Fowlpox. anarypox)

Venezuelan Equine Encephalitis



This application plans to construct re lication-defective human adenovirus
recombinant vectors




Manipulations
Planned:

amines and biotherapeutic reagents.



(5) 'ectors from our collaborator (4), (5)



Source Nature of
inserted DNA
Sequences:



(5)
PMDC demonstrating the absence of replication competent



Hosts and Vectors:





Adenovirus (5)





Action Needed: Approved with Comments



Approval Provide more information Review by Full Cormnittee Designated Review



























. . Pa eri?ed by
Item Quesnon ge Suggestions Corrections Needed cone?qed IBC
Investigator .
Review er
1 I Exper 3 Indicate what work will be done at BSL2 BSL3 I:
Design
2 1c.d.e 5 Update to Biosafetz Level 3
3 IV-2 6 cannot work















Plum Island Biosafety Committee

January 8. 2013 Minutes









on the protocol until their Lab Safety Training is
completed (Min annual requirements)





















Date: 1/8/13

Investigate?

Application

D-la. 111 D-lb. D-2a D-4c
Sect10n(s):



Containment Level:

The Board Approved agents at a BSL-2 BSL-3



Agent Characteristics:



FMDV (5)



Manipulations
Planned:



To introduce mutations and/or deletions in infectious clones in various regions of
the FMDV genome to stud the role of the viral encoded roteins in virus re lication and
in virus-host interactions.





Source Nature of
inserted DNA
Sequences:



DNA Sequences will come from NA insert contains the full length or
partial sequence of FMDV. 011 the 5' end of the construct a T7 polymerase promoter has
been added to enable in vitro transcription of the construct.



Hosts and Vectors:



E.coli(DH5al ha/to 10 .Plasmids RMC 35. LLV2. A24Cru.





Approval

Provide more information

II Review by Full Committee I: Designated Review



Action Needed: Approved with Comments







































XI Approval IE Provide more information Review by Full Committee Designated Review
. Pa Veri?ed by
Item Quesuon ge Suggestions Corrections Needed cone_c.ted IBC
Investigator .. .
Re\ rew e1
1 I Exper 3 Indicate what work will be conducted at BSL2. if El
Design any. If no work is to be conducted in BSL2. un-
select the check box on the top of page 5.
7 I Exper 3 Add explination of FMDV Replicon work to be :1 El
Design conduct {and where it will be conducted)
annot work
3 IV-2 6 011 the protocol until their Lab Safety Training is El
completed (Min armual requirements)
Date: 1 9/ 1 3
Investigator:
Application
Application Date: 12/27/12
NIH Guideline
-7 - -
Section?): 111 -a 6









Plum Island Biosafety Committee January 8. 2013 Minutes



Containment Level: The Board Approved agents at a BSL-3 Level.



Agent Characteristics:





This application plans to routinely characterize animal disease agents and experimentally
derived plasmids or DNA from diagnostic or research investigations at





Manipulations
Planned:

111 accordance


with standard USDA and PMDC Safety Of?ce procedures and approvals.

inserted DNA (5)

Sequences: Eukaiyotic. prokaiyotic. viral organisms. RNA or DNA.
coli 12 Host Vector Systems to be used (K 12 derived strains HB101.

JMIO9 and TOP 10). Bacterial plasmids or PUC derived vector plasmids
and bacteriophage.



Source Nature of

and other



Hosts and Vectors:







Action Needed: Minor Changes
Approval Provide more infonnation Review by Full Committee



Designated Review







































Item Question Pa C01rected ve??ed by
ge Suggestions 01recti0ns Needed hwestioato:
Reviewer
1 LC 6 (5) should be listed as BSL 3
2 l. 6 (5) should be listed as BSL 3
3 7 have not yet completed the necessary
training modules.
Date: 9/24/12
Investigator: (D) (5)
Application













Plum Island Biosafety Committee

Application Date:
NIH Guideline
Section(s):
Containment Level:
Agent Characteristics:
Manipulations
Planned:
Source / Nature of
inserted DNA
Sequences:
Hosts and Vectors:

January 8, 2013 Minutes

8/13/12
III D-1b, III D-2a & III D-4b
The Board Approved agents at a BSL-3 Level.
ASFV (b) (5)
genes encoding immunogenic ASFV proteins.
This project has two main objectives: (i) develop by genetic manipulation ASFV strains
that can be used as live attenuated vaccines, and (ii) test the hypothesis that isolated viral
proteins can be used as experimental immunogen against ASFV infection.
(b) (5)
ASFV (b) (5)
Bacterial Plasmid – pAYC177, pdIIIGFP (b) (5)
Cell Cultures (LFBK, SK6, PBNC); (b) (7)(F)

; E-coli DH5; Primary
E-coli (K-12); (b) (5)

(b) (5)

Action Needed: Approved
Approval
Provide more information
1/8/13
Date:
Investigator:

(b) (6)

Application #:

023-12-R

Application Date:
NIH Guideline
Section(s):
Containment Level:

11/26/12

Agent Characteristics:

Review by Full Committee

Designated Review

III-D-1a, III-D-1b, III-D-2a, III-D-4b & III-F
The Board Approved agents at a BSL-3 Level.
E.coli (DH5 derivative competent cell)
HEK293 (Transformed human cell line)
LFBK (Established bovine cell line)
(b) (5)

FMDV (b) (5)
This application plans to design a leading peptide sequence based on bovine secretory
protein sequences. (b) (5)

Manipulations
Planned:

Source / Nature of
inserted DNA
Sequences:
Hosts and Vectors:

E.coli will be received from commercial vendor. HEK293 & LFBK will be provided by
will be obtained from (b) (6), (b) (7)(F) and FMDV
(b) (5) will be provided by(b) (6)
.
Adenovirus (b) (5)
pUC57C, pMV-HA, pCEP4, e.coli (NEB
Competent), Tissue cultures (established and transformed cell lines).
(b) (6), (b) (7)(F)

For Official Use Only
This document contains sensitive information exempt from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 552(b) (2)
Do not release without prior approval of the Department of Homeland Security

 Plum Island Biosafety Committee

January 8. 2013 Minutes



Action Needed: Approved with Comments































pprova rovi more in onnation eview ominittee esignate eview
A 1 11
. Pa Veii'fied by
him (2116:1011 ge Suggestions Corrections Needed  IBC
3 Reviewer
1 II 5 6 Indicate if you will be perfonning work within
BSL-Z
Date: 1/8/13
Investigator:
Application
Application Date: 11/26/12



NIH Guideline
Section(s):





Containment Level:

The Board Approved agents at a BSL-3 Level.



Agent Characteristics:

E.coli derivative competent cell)
HEK293 (Transfonned human cell line)
LFBK (Established bovine cell line)









Manipulations
Planned:





Source Nature of
inserted DNA
Sequences:

use ?ve additional a roaches to increase the efficac of IPN biothera eutics including

The competent E. coli will be provided by

HEK293 and LFBK are provided by
(NH

(4). (0) WW)

(6). (0) (NH











Hosts and Vectors:

Adenoviius (human Ad5 with deletion). 57C . e.coli (NEB
Competent). Tissue cultures (established and transfonned cell lines).



Action Needed: Approved with Comments

















Approval Provide more Review by Full Committee Designated Review
. Pa Veri?ed by
Item iiestion . . Corrected
ge Suggestions Corrections Needed . 3' IBC
Investigator .
Reviewer
1 5 6 Indicate if you will be perfonni'ng work within









Plum Island Biosafety Committee January 8. 2013 Minutes



BSL-Z













2 Id 6 Change to BSL-3



C. Old Business
C.1 FMDVAcetone Inactivation

C.1.1 This project is no longer speci?c to. The

exemption of acetone ?xed intermediate tissues is a more accurate
descriptor. The committee reviewed the results that has provided
and at this point it was determined that this information should be refeiied to
the Select Agent Program, through for fluther guidance.

Meeting Adjourned 10:45am







Minutes
Plum Island Biosafety Committee
Date:

27 January 2014

Time:

9:00 am

Place:

DHS Science Conference Room, (b) (7)(F)

Recorded by: Kris Dooley, Thamus Morgan
Members Present: Geoffrey Ferman, Karon Floyd, Bruce Harper, Chris Schutta, and William
White
Members Absent: Scott Campbell and Ming Ding

A.

New Business

A.1 Introduction of Dr Morgan replacing Ms Kris Dooley
A.1.1 The IBC welcomed Dr Thamus Morgan
A.2 Review/Approval of Minutes from 12/12/2013
A.2.1 Approved as submitted
A.3 Review of IBC Charter
A.3.1

Ms. Floyd will provide modifications necessary based on updated NIH
Guidelines where the select agent regulations or the NIH guidelines refer to
the less than 75 % genome rule. The IBC charter should reflect the same
language of whichever document the reference appears in

A.4 Recommendation of AALAS training module as IBC annual training requirement
A.4.1 Recommendation of an AALAS Animal Biosafety Training Program module
to be used as the annual IBC continuing education module. Title of module
is: Institutional Responsibilities and Animal Biosafety. This training was
approved by the group.

A.4.2 All IBC members already have an account with the AALAS Library (Ms.
Kris Dooley – PIADC Administrator)

B.

Review of Biosafety Applications:

B.1

Review Summary

Application
016-12-R

Application Type
Major Amendment

Outcome of Today’s Review
Deferred

023-12-R

Annual Review

Approved

024-12-R

Annual Review

Approved

027-13-R

New Protocol

Deferred

B.2
Details – Full Committee Reviews
Date:

27 January 2014

1

 (b) (6)

(b) (5)

(b) (5)

(b) (5)

(b) (5), (b) (6), (b) (7)(F)
(b) (5)

(b) (5)

(b) (6), (b) (7)(F)

(b) (6), (b) (7)(F)

(b) (5), (b) (7)(F)
(b) (5)
(b) (5)

(b) (5)



(5)
2_ (5)

3. To enhance host response to vaccination, host cytokines and chemokine
genes will be selected based on reported functions and inserted into the
vector. The expression in cell culture will be tested using Western
blotting.







Source Nature of
inserted DNA

Sequences:



b-
c-
d-



Hosts and Vectors:

Vector: human Ad5 with the E1 and E2 deletion; plasmid:
(Genscript), and (lnvitroqen) Host: XE. coli: Name
vative or strain: NEB 5-alpha competent E. coli (Cat#029871 K-12 Strain)



















Approval Provide more infonnation II Review by Full Committee I: Designated Review
. Pa Ven'?ed by

Item Quesnon ge Suggestions Con?ections Needed ecied b? IBC

Inx est1gat01 Reviewer

1 Please indicate that (5) is not a select

agent
What are our hazardous materials?
2

















Please make a list of virues to be used as









3 IV 6 antigen
4 8 Please update training dates
Please add the person you talked to as an
5 VI 9 industrial hygienist and the date of the
conversation
Geoff Ferman is your designated reviewer.
6 Once you complete the above items and El

consulted with Geoff Ferman, an approval
letter will follow.



























Date: 27 January 2014

Investigator:

Application 024-12-R

Application Date: 13 Febmary 2012

 D-la. 111 D-lb. 111 D-4b. Other:



Containment Level: BSL-S



E. coli NEB 5-alpha competent E. coli; HEK293 transformed human cell line
Agent Characteristics: LFBK established bovine cell line; IBRS-2 established porcine cell

Recombinantw gge 5! replication-defectivem-





1. DNA shuf?ing technique described by Stemmer (Proc. Natl. Acad. Sci.
1994, 91 :10747-10751) has been successfully used to create new IFN
genes with signi?cantly increased antiviral activity (Brideau-Andersen et
al., Proc. Natl. Acad. Sci. 2007, New bovine type IFN

k: O?l? . 0? ?0 .II.







2_ (5)

Manipulations
Planned:

3. (5)

4_ (5)







5.

7.

$9





Source Nature of
inserted DNA
Sequences:



9?



(5). (6)

(5).

(5). (0) WW)



'Jl

(b) (5), (b) (7)(F)

(b) (4)
(b) (5), (b) (6)
(b) (6), (b) (7)(F)

(b) (6), (b) (7)(F)
(b) (5)

(b) (5)

(b) (6)

(b) (5), (b) (7)(F)

(b) (5)



(5)



Source Nature of
inserted DNA
Sequences:





Hosts and Vectors:





Host:
Shot (5)





et a: Plasmid: Zero Blunt TOPO. and Host-E. coli-One





















































pprova l'OVl more 111 onnatlon eVleW ?51g11ate emew
Ven'?ed by
1:111 Quitlon ge Suggestions  Con?ections Needed  IBC
Reviewer
Ill10

C.

other

-

Please work with Geoff Ferman on MSDS
information for VSV

Training

C.1 None occurred
Meeting Adjourned 10:45am

8

 Minutes
Plum Island Biosafety Committee
Date:

4 April 2014

Time:

9:00 am

Place:

DHS Science Conference Room, (b) (7)(F)

Recorded by: Kathy White / Karon Floyd
Members Present: Geoffrey Ferman, Karon Floyd, Chris Schutta, Ming Deng, Kim Andrews
and William White
Members Absent: Scott Campbell and Bruce Harper

A.

New Business

A.1 Introduction of Dr. Karon Floyd replacing Dr. Bruce Harper
A.1.1 The IBC welcomed Dr. Karon Floyd as Chair
A.2 Review/Approval of Minutes from 01/08/2014
A.2.1 Reviewed, 2 changes made and approved
A.3 Review of IBC Charter
A.3.1

Ms. Floyd provided modifications necessary based on updated NIH
Guidelines; however, the IBC Charter will be revised again. Ms. Floyd
requested guidance from Committee to either approve Charter as presently
written or wait until all changes have been made – Committee voted to table
Charter review until all changes have been made.

A.4 Animal trailer decontamination SOPs / Animal deliveries
A.4.1 A PIADC animal transport trailer needs to be replaced.
A.4.2 In accordance with the Animal Welfare Act 9 CFR part 3 (subpart F)
“…animals must be maintained above 45 degrees Fahrenheit for transport…”

A.4.3 In accordance with best practices of biosecurity, two trailers are needed to
ensure there is no cross contamination coming onto or going off the Island
when transporting animals.

A.4.4 The present SOPs (DHS & Primus) for animal trailer decontamination are
adequate.

A.5 Personal Recognizant Quarantine
A.5.1 Discussion of PRQ and the ownership of birds & rabbits
A.5.2 Group decided more discussion was needed, to include input of the Senior
Leadership Group

A.5.3 Awaiting SLG feedback
A.6 Use of Contact lens within biocontainment
A.6.1 Current policy – “contact lenses not allowed in biocontainment (B101 /
B102)

v.6

1

 A.6.2 BMBL recommendations “…use of contact lenses with appropriate eye
protection…”

A.6.3 Discussion of group
? Allow contact usage within Zone 2 – mechanical spaces, hallways, and the
lunchroom

? Allow contact lens usage within Zones 2, Zone 3 and Zone 4 – laboratories
and animal containment areas, and necropsy with appropriate eye
protection .

A.7 Usage of FitBit Flex wrist band
A.7.1 Employee owned, waterproof design, device is an exercise-sleep monitor
used in weight reduction programs.

A.7.2 Not an essential piece of equipment required for employment
A.7.3 Request not approved.
A.8 Recommendation of AALAS training module as IBC annual training requirement
A.8.1 Approved.
B.

Review of Biosafety Applications:

B.1

Review Summary

Application
016-12-R

Application Type
Major Amendment

Outcome of Today’s Review
Approved

015-12-R

Annual Review

Approved

003-12-R

Annual Review

Approved

027-13-R

New Protocol

Approved

028-14-D

New Protocol

Approved with Comment

007-12-R

Annual Renewal

Approved

014-12-R

Annual Review

Approved

022-13-R

Annual Review

Approved

B.2
Details – Full Committee Reviews
Date:

27 January 2014

Investigator:

(b) (6)

Application #:
NIH Guideline
Section(s):
Containment Level:
Agent Characteristics:

016-12-R
III D-1a, III D-1b, III D-2a & III D-4b
The Board Approved agents at a BSL-2 & BSL-3
Human Adenovirus (b) (5)
, FMDV (b) (5)

VSV (b) (5)

We will (b) (5)
Manipulations
Planned:

v.6

2



mm The goal of these
studies is to understand the interaction of Viral and 110st proteins and the role
of these interactions in the pathogenesis of





Source Nature of
inserted DNA
Sequences:

(5) renilla luciferase: Rem/la reniformis (Sea
Pansy) and Rem/la mullerei (Gulf of Mexico) are species of soft coral; green
?uorescent protein: jelly?sh Aequorea Victoria.

a. (6). (NH

b. (D) (6). (0) (NH



Hosts and Vectors:

(5)

. Bacterial Plasmids E.coli (nonpathogenic) and
Tissue Cultures.































Approval Provide more information Review by Full Committee Designated Review
. Pa Veri?ed by
Item Quesnon ge Suggestions C01recti0ns Needed ecied b? IBC
Inx est1gator v. - .
Rex 1ew e1

Date: 3 April 2014
Investigator:
Application 028-14-D
Containment Level: BSL-3



Agent Characteristics:

Chlorine Dioxide and Vaporous Hydrogen Peroxide Decontamination Study with
Foreign Animal Disease Viiuses



Manipulations
Planned:



(5)











(5)





Source Nature of





1. PIADC (6), (D) (W)























































2. Biological Material
Sequences:
XI Approval Provide more information I: Review by Full Committee I: Designated Review
. Pa Veiified by
Item Quesuon ge Suggestions 1" Con?ections Needed ecied IBC
Im estigatm v.
Rex 1ewe1
1 111.1 6 Add Agent for biological indicator
Check yes to will you be working with
2 IV.1 7 infectious micro-organisms and/or
human/primate cell lines
Date: 27 January 2014
Investigator:
Application 027-13-R
NIH. Guldelm? D-la. 111 D-4b
Sect10n(s):
Containment Level: ESL-3
Agent Characteristics: (5), (NH
(0) (5)
Manipulations
Planned:
The goal of these studies is to understand the viral and 110st factors determining
(5) . such as the role of speci?c viral proteins and the interaction of
v.6

4





viral and 110st roteins and the role of these interactions in the athoaenesis of







E. Coli attenuated laboratory strains sold from
TOP10 Chemicall Com etent E. coli. These commericall available bacteria



Source Nature of







inserted DNA

Sequences:

Zero Blunt TOPO. and Host-E. coli-One
0" 5 a? 9? Shot piq (Sus scroffa) and cattle (Bos taurUS)



Approval Provide more infonnation Review by Full Committee Designated Review







C. Training

C.1 Handouts were provided by Ms. Floyd for training. Due to time constraints. training
will be sent to lV'Iembership

Meeting Adjoruned 11:00 am

v.6





Minutes

Plum Island Biosafety Committee

Date: 20 J1me 2014
Time: 9:00 am
Place:

Recorded by: Thamus Morgan DVM. MPH

Members Present: Geoffrey Ferman. Karon Floyd. Clnis Schutta. Fawzi Mohammed. Manuel
Borca. Jennifer Smoliga. and William White

Members Absent: Scott Campbell. Kim Andrews. Ming Deng

A. New Business

A.l Change to application form

A.1.1

Section Personnel

0 Strike ?Contact the Biosafety Of?cer if you have questions at (6)

(5)

The current Biosafety Of?cer does not oversee present laboratory training

of personnel.

0 This change will be applied to each new application and review forward.

A.1.2 Approved by committee

A.2 Review Approval of Minutes front 4 April 2014

.2.1 Reviewed. 3 changes made and approved

0 Section A.5.3 Awaiting SLG decision

0 Section A.6.3 Contact lens can be worn in Zones 2. 3. 4 provided that

appropriate protection is also wom.

0 Section A.7.3 Request (to wear Fitbit) was not approved.

B. Review of Biosafety Applications:

B.l Review Summary

















Application Application Type Outcome of Today?s Review
012-12-D Major Amendment Approved
0 1 3-12-R Annual Review Approved
025-12-D Annual Review Approved
v.2 6.25 .2014



B.2

Details Full Committee Review











Date: 20 June 2014

Investigator:

Application 012-12-D

?Hpu?delme D-la. n1 D-2a. D-4a
Section(s):



Containment Level:





Agent Characteristics:

Manipulations
Planned:

Foot and Mouth Disease
?Experi1nental Design





A


A
01


?Personal Protective Equipment and Biosafety
(5)





Source Nature of
inserted DNA
Sequences:

Source
a. USDA - APHIS - ARS



c. AmLcommercial vendor providinq DNA oliqonucleotide services

0'



Nature
(5)





Hosts and Vectors:





Host: g5. coli: Name derivative or strain:

Vectors:

(D) (5)









to

6.25.2014







(D) (5)

Approval Provide more information Review by Full Committee



Designated Review

















. . Pa Veri?ed by
Item Quesuon ge Suggestions Corrections Needed conegcled IBC
Investigator .
Review er
3 Change face shield use to prevent splatter rather

1 . . . . .
than aeiosol mhalation protection

7 3 Change BSL2 biosafety cabinet to BSL3. Class II X,

biosafety cabinet

Sec IV.6 6 Change  . .aerosol containment capsules for BSL3

3 contaimnent" to  . .aerosol contaimnent rotors and

cups?









C. Training

C.l No training this meeting

Meeting Adjomned at 9:30 am

to

6.25.2014

U)



Minutes

Plum Island Biosafety Committee

Date: 20 June 20l4
Time: 9:00 am
Place: (WMF)

Recorded by: Thamus Morgan DVM, MPH

Members Present: Geoffrey Ferman, Karon Floyd, Chris Schutta, Fawzi Mohammed, Manuel
Borca, Jennifer Smoliga, and William White

Members Absent: Scott Campbell, Kim Andrews, Ming Deng
A. New Business
A.1 Change to application form

A.l.l Section Personnel

0 Strike ?Contact the Biosafct Of?cer if ou have questions (0)

0 The current Biosafety Of?cer does not oversee present laboratory training
of personnel.

0 This change will be applied to each new application and review forward.
A.l.2 Approved by committee
A.2 Review Approval of Minutes from 4 April 2014



A.2.1 Reviewed. 3 changes made and approved

0 Section A.5.3 Awaiting SLG decision concerning the PRQ and the
ownership of rabbits birds by employees

0 Section A.6.3 Contact lens can be worn in Zones 2, 3. 4 provided that
appropriate protection is also worn.

0 Section A.7.3 Request (to wear Fitbit) was not approved.

B. Review of Biosafety Applications:

Review Summary











Application Application Type Outcome of Today?s Review
012-12-D Major Amendment Approved
Annual Review Approved
025-12-D Annual Review Approved









v.2 6.25.2014

8.2

Details - Full Committee Review

Date:

20 June 20 I4



lnvestiga tor:

John Neilan



Application





NIH Guideline
Section(s):

[ll D-la. 0-221. 8; [ll D-4a



Containment Level:

BSL-3



Agent Characteristics:

Pam and Mouth



Manipulations
Planned:

'Fx crimental Desi in



'Personal Protective Equipment and Biosaf?ety

PPF. for persons working in the animal rooms will include disposable 'l?yvek suits and
gloves. Gloves will be taped when evidence oi?an active secondary infection is seen
within the herd. such as ringworm or pustular stomatitis. l-?ace shields will be worn
during FMDV challenge inoculation to protect against splash splatter to face. All
individuals will be required to shower-out prior to exiting the animal room. In the
laboratory. all samples collected from the animal wings will be treated as potentially
infectious and will be processed inside a BSL3 Class biosafety cabinet. Disposable
tubes and plasticware will be used to process clinical samples and all waste will be steam
autoclaved under high pressure for 45 minutes prior to collection for disposal. Sharps
will be disposed of in an approved sharps container.



Source Nature of
inserted DNA
Sequences:

Source

a. USDA - APHIS - ARS

b. (4)

c. Any commercial vendor providind DNA oliqonucleotide services

Nature
(5)





Hosts and Vectors:



Host: E15 edit Name derivative or strain:

ectors:

Adenovirus human Aditproprietarv)

ls thisstrain replicative defective? Yes 0V0

Adenovirus Name strain and describe wild type deletions: human Adl4
(proprietan)

ls thisstrain replicative defective? Yes (No

(5.25.2014



Name strain and_describe wild type deletionsz'





is this strain replicative defective? Yes 0N0
1 Al ha-Virus like particles Name strain and describe wild tvpe deletions:
capsids( proprietary)





Approval Provide more information Review by Full Committee El Designated Review



















ll ?l?l I: l'l' - in Vern-In! h)
A I 2c Siiuucst on? Corrections \cctictl . ii
.
. l<c\
1 3 Change face shield use to prevent splatter rather
than aerosol inhalation protection
2 3 Change BSLZ biosafety cabinet to BSL3, Class ll
biosafety cabinet
Sec lV.6 6 Change containment capsules for BSL3
3 containment" to  . .aerosol containment rotors and
a ?1125"
C. Training
No training this meeting
Mccting Adjourned at 9:30 am
v.2 6.25.2014



U.S. Department of Homeland Security
Washington, DC 20528

January 6, 2015

Alison Young
Reporter
USA Today
7950 Jones Branch Drive
McLean, Virginia 22108
Sent Via Email to: ayoung@usatoday.com
RE: 2015-STFO-017
Dear Ms. Young:
This is the final electronic response to your Freedom of Information Act (FOIA) request to the
U.S. Department of Homeland Security (DHS), Science and Technology Directorate (S&T),
dated December 8, 2014. You are seeking all laboratory incident reports that occurred at Plum
Island Animal Disease Center (PIADC) from January 1, 2013 to the date your request was
received in this office on December 10, 2014.
S&T’s Office of National Laboratories conducted a search for documents responsive to your
request. The search of network files for the key terms PIADC, 2013, 2014, and laboratory
incident produced a total of 11 pages. Of those pages, I have determined that two pages of the
records are releasable in their entirety, nine pages are partially releasable, and zero pages are
withheld in their entirety pursuant to Title 5 U.S.C. § 552 (b)(3), (b)(6), and (b)(7)(F).
Enclosed are 11 pages with certain information withheld as described below.
FOIA Exemption 3 protects information specifically exempted from disclosure by another
statute, if the statute (A) requires that the matters be withheld from the public in such a manner
as to leave no discretion on the issue, or (B) established particular criteria for withholding or
refers to particular types of matters to be withheld. See Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (P.L. 107-188) Section 212(h).
FOIA Exemption 6 exempts from disclosure personnel or medical files and similar files the
release of which would cause a clearly unwarranted invasion of personal privacy. This requires a
balancing of the public’s right to disclosure against the individual’s right privacy. [The types of
documents and/or information that we have withheld may consist of birth certificates,
naturalization certificates, driver license, social security numbers, telephone numbers, home
addresses, dates of birth, email addresses, or various other documents and/or information
belonging to a third party that are considered personal.] The privacy interests of the individuals

 in the records you have requested outweigh any minimal public interest in disclosure of the
information. Any private interest you may have in that information does not factor into the
aforementioned balancing test.
FOIA Exemption 7(F) permits the government to withhold all information about any individual
when disclosure of information about him could reasonably be expected to endanger the life or
physical safety of any individual. This exemption also protects physical security at critical
infrastructure sites. [The types of documents and/or information withheld could consist of
names, addresses, telephone numbers, source provided information, such as testimony,
statements, reports, investigations, audio/video tapes, or various other documents or information
withheld as to not endanger the life or physical safety of an individual. This exemption would
also apply to physical security at any site, so long as the information is about a person.]
You have a right to appeal the above withholding determination. Should you wish to do so, you
must send your appeal and a copy of this letter, within 60 days of the date of this letter, to:
Associate General Counsel (General Law), Mailstop 0655, U.S. Department of Homeland
Security, Washington, DC 20528, following the procedures outlined in the DHS regulations at 6
C.F.R. § 5.9. Your envelope and letter should be marked “FOIA Appeal.” Copies of the FOIA
and DHS regulations are available at www.dhs.gov/foia.
The Office of Government Information Services (OGIS) also mediates disputes between FOIA
requesters and Federal agencies as a non-exclusive alternative to litigation. If you are requesting
access to your own records (which is considered a Privacy Act request), you should know that
OGIS does not have the authority to handle requests made under the Privacy Act of 1974. If you
wish to contact OGIS, you may email them at ogis@nara.gov or call 1-877-684-6448.
Provisions of the FOIA [AND PRIVACY ACT] allow us to recover part of the cost of
complying with your request. In this instance, because the cost is below the $14 minimum, there
is no charge. If you need to contact our office again about this matter, please refer to 2015STFO-017. This office can be reached at stfoia@hq.dhs.gov or (202) 254-6342.
Sincerely,

Katrina Hagan
FOIA Officer

Enclosures:

Responsive Documents, 11 pages

 Needle Stick
Select Agent: (b) (3) (B)
Characterization of Agent:
1. A24 2. Recombinant replication-defective human adenovirus
serotype 5
Quantity:
0.5 ml
Name of agencies or local authorities notified: The PIADC Biosafety Officer and Responsible Official
notified using established procedures. The Nurse Practitioner was notified and attended to the
employee. The USDA Medical Review Officer notified by the nurse. RO notified Agricultural Select Agent
Service by email.
On 3/5/14 at approximately 1100 (b) (6), (b) (7)(F)
Detail Summary of Events:
was performing challenge inoculation on a pig vaccinated with recombinant replicationdefective human adenovirus blue serotype (b) (3) (B)
vaccine. The challenge virus
(b) (3) (B)
contained
. The employee was performing heel bulb inoculation on an anaesthetized and
restrained pig and during the first inoculation the pig jumped, a normal response, and the syringe left
the pig heel and entered the employee’s finger. Initially the employee squeezed (b)
finger to expel
(6)
blood and finished the inoculation. Upon completion of the inoculation, the employee removed (b)
(6)
gloves, disinfected the area with ethanol and bled (b)
finger more. Prior to inoculation, the animal’s
(6)
heel was cleansed with ethanol. The employee was wearing appropriate PPE and clothing including;
tyvek, boots, double gloves and face shield. The employee performed appropriate personal
decontamination procedures. The employee waited until the next day, 3/6/2014, to notify(b)
first line
(6)
supervisor who waited until 3/7/2014 to notify the Research Leader who instructed the employee to
visit the occupational health nurse. The Research Leader notified the Biosafety Officer and Center
Director who notified the Responsible Official at approximately 6:15 PM on 3/7/2014.

(b) (6), (b)
(7)(F)

The Occupational Health Clinic was closed by the time the employee visited and an appointment was
made for her to visit with the Occupational Health Nurse the following day, 3/8/2014
Exam was unremarkable and employee denied any unusual signs and/or symptoms. Employee
instructed to follow-up with the clinic on Monday of the next week.
Section 3
Internal Review of Procedures: In accordance with the PIADC Biological Safety and Security Plan we
have initiated an internal review of the procedure summarized below:
1. The employee was referred to the Federal Occupational Health Clinic for an evaluation by
the clinic’s nurse in collaboration with the USDA Medical Review Officer.
2. The employee maintains strict prohibition in accordance with the PIADC Personal
Recognizant Quarantine from visiting locations where susceptible livestock are housed
during the evaluation period.

 3. The medical examination was unremarkable and the employee was directed to follow-up
with daily temperatures for a week.
4. We have reviewed our internal procedures for use of Personal Protective Equipment,
Incident Notification, Animal Handling, and Sharps and have found them to be current with
no change warranted. However, the employee and supervisor were trained on the proper
procedures for incident notification for occupational exposure and theft, loss, and release of
a select agent.
None with qualification. (b) (3) (B)
is not zoonotic,
Hazards posed by release:
therefore not infectious to humans with no potential for amplification outside of ABSL-3 providing that
appropriate topical decontamination of the body area is taken. The employee is maintaining personal
recognizant quarantine and continued follow-up with the medical review officer.
None with qualification.
Estimated extent of release or exposure:
is not zoonotic, therefore not infectious to humans with no potential for
amplification outside of ABSL-3 providing that appropriate topical decontamination of the body area is
taken. The employee is maintaining personal recognizant quarantine and continued follow-up with the
medical review officer.

(b) (3) (B)

The affected area was squeezed until blood was expressed and then
Area was decontaminated:
scrubbed with ethanol prior to leaving the Animal Isolation room. The employee exited the ABSL-3
facility using established personal decontamination procedures. When animal isolation rooms are
vacated the rooms are washed from floor to ceiling with carbochlor and then 2% Virkon.
Medical treatment was provided:
The employee reported to the PIADC occupational nurse two
days after the incident happened. The wound was unremarkable and showed no signs of infection. The
employee was instructed on signs and symptoms of infection and instructed to follow-up with the nurse.
At the time of initial visit there was no indication for prophylactic medication.

 Biological Material Spill
Select Agent: (b) (3) (B)
Characterization of Agent:
A 24 Cruzeiro
Quantity:
96 Well plate
Name of agencies or local authorities notified: The PIADC Biosafety officer and Alternate Responsible
Official notified using established procedures. RO activated the Incidence Response Plan-Release of CFR
agents and USDA APHIS Select Agent Program, (b) (6)
by email.
Detail Summary of Events:
On 30 April 2013 at about 3:10 an incident happened in room (b) (7)(F)
(b) (3)
Lab (b)
area. A 96 well plate caught on scientists sleeve as they were adding another
(7) floor in the (B)
plate to the incubator. The plate described above fell to the floor and landed right side up with the lid
slightly ajar. The majority of the media (EMEM, virus dilution, and cells) were still in the plate. Paper
towels were sprayed with a saturating quantity of 10% bleach and placed on top of the spill for a
minimum contact time of 20 minutes. The plate and towels were then autoclaved. An expanded area
was bleached again and those paper towels were also autoclaved. The area that contained the spill was
approximately 1 square foot.
At approximately 15:20 the ARO was notified of the incident by the scientist. They discussed
decontamination and spill containment procedures. There was no need for the scientist to report to the
FOH clinic as this was not a zoonotic agent and there were no injuries. The spill was contained and
decontaminated effectively. There was minimal likelihood that the spill aerosolized to a much larger
area as the lid was still covering the plate and there was a very small amount of liquid from the plate.
Section 3
Internal Review of Procedures: In accordance with the PIADC Biological Safety and Security Plan we
have initiated an internal review of the procedure summarized below:
1. The scientist maintains strict prohibition in accordance with the PIADC Personal Recognizant
Quarantine from visiting locations where susceptible livestock are housed during the
required period.
2. We have reviewed our internal procedures for use of Personal Protective Equipment;
Incident Notification, Spill Response and have found them to be current with no relevant
changes warranted.
Hazards posed by release:
None with qualification. (b) (3) (B)
is not zoonotic,
therefore not infectious to humans with no potential for amplification outside of the enhanced BSL-3
laboratory. The employee performed standard personal decontamination according to facility protocol.

 The employee is maintaining personal recognizant quarantine. The spill was inside an enhanced BSL3
laboratory space with HEPA filtration of both the supply and exhaust ventilation.
Estimated extent of release or exposure:
Minimal to none with qualification. (b) (3) (B)
is not zoonotic, therefore not infectious to humans with no potential for amplification
outside of the enhanced BSL-3 laboratory. The employee performed standard personal
decontamination according to facility protocol. The lid remained on the 96-well plate with a few
droplets escaping to the floor. The area was immediately covered with a saturating quantity of 10%
bleach and paper towels to minimize aerosol spread and facilitate decontamination. The spill was inside
an enhanced BSL3 laboratory space with HEPA filtration of both the supply and exhaust ventilation. The
employee is maintaining personal recognizant quarantine according to facility policy.

(b) (3) (B)

Area was decontaminated:
The area was immediately covered with 10% bleach and paper towels to
minimize aerosol and effect decontamination. Paper towels were saturated with 10% bleach for a
minimum contact time of 20 minutes. The plate and towels were then autoclaved. An expanded area
was bleached again and those paper towels were also autoclaved. The area that contained the spill was
approximately 1 square foot.
Medical treatment was provided:
There were no injuries and no medical treatment provided.
is not zoonotic, therefore not infectious to humans with no potential for
amplification outside of the enhanced BSL-3. Staffs are required to perform a personal decontamination
shower prior to leaving the facility.

(b) (3) (B)

 amrdous Material Spills 2013-2014
3/18/14 ?Spill of Trizol Reagent?

. rizol Reagent spill of approximately 250ml. The product is
used during protein extraction. See attached for
additional information.



"V?Number: 0?51ng - ENV

Date Time of Discovery: 3/18/14 1312 Hours

Noti?cation Only

PIADC
ONFO

Plum Island Animal Disease Center, Plum Island, NY













Date Time of Noti?cation: 3/ 1 8/14 1400 hours













El EMS was Activated Health Safety Incident? Property Damage Reported"



Details of Nonconformance: (what, when, where, why)
b)

Spill of Trizol Reagent in Spill by USDA personnel of approximately 250 ml of Trizol Reagent i
during lab clean-up.



Actions Taken:
Fire Brigade and environmental personnel responded. EOC opened and DHS noti?ed. Spill mitigated by ?re brigade.
Waste materials handled by environmental personnel. Room secured for overnight period to allow venting. Floor

cleaned with soap and water in the morning in accordance with best practices for phenols. See attached for more
information.























Print Name of Reporter: (0) (61 (0) WW) Signature of Reporter:
Print Name of Supervisor: (0) (6). (0) WF) Signature ofSupcrv?Bo .
Print Name of Project Manager: Signature of Project Manager
Additional Comments:
This area to be ?lled out at PIADC Functional Meeting
Affected El Administration (A) (BS) El Buildings Grounds (BG)





















Operation: Environment (ENV) Fire Activation (F) a IT (IT)

8 Lab-101 (L) Personnel/Physical Security(PS) Quality Assurance (Q)

2] Safety Health*(S) Transportation Utilities (U)

Engineering (B) Bio-Surety (BY)

Other
mppmenv DDesign/Engineering Problem (DSGN) [1 Equipment (EQPT) Personnel Error (PERS)

Contributing [:lManagement Problem (MNGT) Communications (COM) Training De?ciency (TRNG)
Dthemal Phenomenon (EXTL) Procedure Problem (PROC) MJ
Response: 8 Follow Up Required What? After action report

El Work Order By Whom? .

No Further Action Date _Closed: .4 4*

PCAR





?For Health Safety, notify Occupational Health Nurse and DHS Safety Of?cer
See escalation thresholds in SOP-QA-003-O
QA-003-1 Rev.02 2Augl3



azardous Material Spills 2013-2014
3/20/14 Liquid Spill

0 Amount of liquid spilled was approximately 500 ml and was identi?ed as
a liquid containing E.coli DHS alpha non-hazardous waste. See attached
NCR for additional information.



PIADC
NONCONFORMANCE REPORT

Plum Island Animal Disease Center, Plum Island, NY







?--Number: aw







Date Time of Discovery: 03/20/14 1850 Date Time of Noti?cation: 03/20/14 1910













El Noti?cation Only [3 EMS was Activated DHealth Safety Incident* [3 Property Damage Reported?



Details of Nonconformance: (what, when, where, why)
2222/Haz-Mat spill discovered by, (0 outside It corridor.



Actions Taken:

FD activated. Fluid (th) from shaker unit (Innovo 4000) ?uid vessel. Contact Dr. ReSponsible for unit to ID ?uid. FD
mitigated spill as directed.
Notify PM2 whom made additional upper DHS notifications.



Print Name of Reporter: (0) (6). (NF) Signature of Reporte



Print Name of Supervisor: (0) (6). Signature of Supe

Print Name of Project Manager: (6). (NF) Signature of Project . 2--
Additional CommentsAffected Administration (A) [j Bio-Safety/Bio-Security (BS) ?uildings Grounds (BG)
Operation: Environment (ENV) Fire Activation (F) IT (IT)
EH Lab -101 (L) Personnel/Physical Security(PS) Quality Assurance (Q)
Safety Health*(S) Transportation (T) Utilities (U)
Engineering (B) Bio-Surety (BY)
El Other
Apparent] DDesign/Engineering Problem (DSGN) Equipment E?Personncl Error (PERS)
Contributing [:IManagement Problem (MNGT) Communications (COM) [3 Training De?ciency (TRNG)
Causc(s) DExternal Phenomenon (EXTL) El Procedure Problem (PROC)
Response: El Follow Up Required What?
Work Order By Whom?
No Further Action Date Closed: /1 c}
PCAR













*For Health Safety, notify Occupational Health Nurse and DHS Safety Of?cer
See escalation thresholds in SOP-QA-003-O
QA-003-1 Rev.02 2Aug13



ll

t2:



Hazardous Material Spills 2013-2014
12/05/13 ?Battery Acid Spill?

0 Battery backup for computer system overheated causing the
battery case to separate, allowing for battery acid to spill. Sec
NCR.



PIADC
NONCONFORMANCE REPORT

Plum Island Animal Disease Center, Plum Island, NY



Number:















Date Time of Discovery: 12/5/13 0915 Date Time of Noti?cation: 12/5/13 0915







[3 Noti?cation Only [3 EMS was Activated  Health Safety lncident? Property Damage Reported"





Details of Nonconformance: (what, when, where, why)
Acid Spill? Several ounces of acid spilled from computer system back-up battery in the auditorium



Actions Taken:
FD and Hazmat response. Acid neutralized and cleaned up. Affected battery and parts to be disposed of as haz waste

Print Name of Supervisor: Signature of Supervisor:
















Print Name of Project Manager: Signature of Project Mana



























Additional Comments:
This area to be ?lled out at PIADC Functional Meeting .
Affected Administration (A) Bio-Safety/Bio-Security (BS) . ?uildings Grounds (BG)
Operation: 8 Environment (ENV) [3 Fire Activation (F) IT (IT)
Lab-101 (L) El Personnel/Physical Security(PS) Quality Assurance (Q)
Safety Health?(S) Transportation (T) Utilities (U)
Engineering (E) El Bio-Surety (BY)
Other
Apparent/ DDesign/Engineering Problem (DSGN) Equipment (EQPT) [3 Personnel Error (PERS)
Contributing DManagement Problem (MNGT) Communications (COM) [3 Training De?ciency (TRNG)
Causc(s)  :]Extemal Phenomenon (EXTL) Procedure Problem (PROC)
Response: Follow Up Required What?
Work Order By Whom?
END Further Action Date Closed: DEC 9313
PCAR





*For Health Safety, notify Occupational Health Nurse and DHS Safety Of?cer
See escalation thresholds in SOP-QA-003-O
Rev.02 2Aug13



1 February, 2013

MEMORANDUM FOR:

Record

REFERENCE: Incident summary-bite

On 2/1/13 at approximately 1400 a Foreign Animal Disease Diagnostics Course
student who was in the (b) (3) (B)
) was nipped by a pig while
(b) (6)
(b) (6)
wearing tyvek and
skin was pinched.
stated there was a scant amount of
blood on the inside of her tyvek suit. The tyvek was examined carefully and noted
to be intact. The affected area was scrubbed immediately with betadine and ice
was applied.
At approximately 1445 the student was seen by the Nurse Practitioner in the
Clinic and the area noted to be ecchomotic with a minor abrasion. The Nurse
Practitioner cleansed the area with betadine and ice was applied. The NP
contacted the MD Consultant who ordered blood testing for Rabies Titer which
was done and sent to the lab. Bacitracin was applied to the affected area and a
loose dressing was applied.
The Student returned to the Clinic on 2/4/13-2/7/13 for daily evaluation and
treatment with patient teaching and the area had no evidence of infection and
healed well.
On 3/7/13 the Rabies Titer results returned and the end point titer vaccine
response was adequate and the student was notified and copies of the results
were sent to (b) (6) .

Incident Summary
1 February 2013
FOR OFFICIAL USE ONLY

 U.S. Department of Homeland Security
Washington, DC 20528

February 19, 2015

Alison Young
Reporter
USA Today
7950 Jones Branch Drive
McLean, Virginia 22108
Sent Via Email to: ayoung@usatoday.com
RE: 2015-STFO-017
Dear Ms. Young:
This letter is in response to your email dated January 21, 2014 in which you expressed your
concerns regarding the Department of Homeland Security Science and Technology Directorates
final response. You specifically requested S&T to re-examine the approach taken in making final
determinations and the use of FOIA exemption (b)(3), specifically the Bioterrorism Act of 2002.
In your December 8, 2014 you sought all laboratory incident reports that occurred at Plum Island
Animal Disease Center (PIADC) from January 1, 2013 to the date your request was received in
this office on December 10, 2014.
This office exercised discretionary release of information as directed in Attorney General
Holder’s FOIA guidelines issued on March 19, 2009. See
http://www.justice.gov/sites/default/files/oip/legacy/2014/07/23/foia-memorandum.pdf. In our
final response dated January 7, 2015, we asserted FOIA exemptions 3,4,5,6, and 7f. After
further review of these records, we have determined that our withholding of information pursuant
to FOIA exemption (b)(3) Public Health Security and Bioterrorism Preparedness and Response
Act of 2002 also known as the Bioterrorism Act was asserted in error. We have also determined
that portions of information previously withheld pursuant to FOIA exemption 3, will continue to
be withheld pursuant to FOIA exemption 5 for the reasons cited below.
Enclosed are 11 updated pages with certain information withheld under the assertion of FOIA
exemption 5, 6, and 7f.

 FOIA Exemption 5 protects from disclosure those inter- or intra-agency documents that are
normally privileged in the civil discovery context. The three most frequently invoked privileges
are the deliberative process privilege, the attorney work-product privilege, and the attorney-client
privilege. After carefully reviewing the responsive documents, I determined that portion of the
responsive documents qualify for protection under the
•

Deliberative Process Privilege
The deliberative process privilege protects the integrity of the deliberative or decisionmaking processes within the agency by exempting from mandatory disclosure opinions,
conclusions, and recommendations included within inter-agency or intra-agency
memoranda or letters. The release of this internal information would discourage the
expression of candid opinions and inhibit the free and frank exchange of information
among agency personnel.

The redacted information is interexicably intertwined with deliberative information involved
with the policy-making process. See Ryan v. Department of Justice, 617 F.2d 781, 790 (D.C.
Cir. 1980). All non-exempt portions of the records that are not inextricably intertwined with
exempt portions were provided to you. See Mead Data Cent., Inc. v. United States Dep't of the
Air Force, 566 F.2d 242, 260 (D.C. Cir. 1977). The release of this information would cause
foreseeable harm by revealing detailed recommendations for future and developing plans or
alternative avenues for potential strain and vector constructions. The release of this information
would prematurely reveal the details of recommended strain and vector construction for the
development of potential vaccines and other countermeasures which would compromise future
intellectual property rights.
FOIA Exemption 6 exempts from disclosure personnel or medical files and similar files the
release of which would cause a clearly unwarranted invasion of personal privacy. This requires a
balancing of the public’s right to disclosure against the individual’s right privacy. [The types of
documents and/or information that we have withheld may consist of birth certificates,
naturalization certificates, driver license, social security numbers, home addresses, dates of
birth, or various other documents and/or information belonging to a third party that are
considered personal.] The privacy interests of the individuals in the records you have requested
outweigh any minimal public interest in disclosure of the information. Any private interest you
may have in that information does not factor into the aforementioned balancing test.
FOIA Exemption 7(F) permits the government to withhold all information about any individual
when disclosure of information about him could reasonably be expected to endanger the life or
physical safety of any individual. This exemption also protects physical security at critical
infrastructure sites.
You have a right to appeal the above withholding determination. Should you wish to do so, you
must send your appeal and a copy of this letter, within 60 days of the date of this letter, to:
Associate General Counsel (General Law), Mailstop 0655, U.S. Department of Homeland
Security, Washington, DC 20528, following the procedures outlined in the DHS regulations at 6
C.F.R. § 5.9. Your envelope and letter should be marked “FOIA Appeal.” Copies of the FOIA
and DHS regulations are available at www.dhs.gov/foia.

 The Office of Government Information Services (OGIS) also mediates disputes between FOIA
requesters and Federal agencies as a non-exclusive alternative to litigation. If you are requesting
access to your own records (which is considered a Privacy Act request), you should know that
OGIS does not have the authority to handle requests made under the Privacy Act of 1974. If you
wish to contact OGIS, you may email them at ogis@nara.gov or call 1-877-684-6448.
Provisions of the FOIA [AND PRIVACY ACT] allow us to recover part of the cost of
complying with your request. In this instance, because the cost is below the $14 minimum, there
is no charge.
If you need to contact our office again about this matter, please refer to 2014-STFO-017. This
office can be reached at stfoia@hq.dhs.gov or (202) 254-6342.
Sincerely,

Katrina Hagan
FOIA Officer

Enclosures:

1) Incident Reports, 11 pages

 Biological Material Spill
Select Agent: Foot-and Mouth Disease Virus
Characterization of Agent:
A 24 Cruzeiro
Quantity:
96 Well plate
Name of agencies or local authorities notified: The PIADC Biosafety officer and Alternate Responsible
Official notified using established procedures. RO activated the Incidence Response Plan-Release of CFR
agents and USDA APHIS Select Agent Program, (b) (6)
by email.
Detail Summary of Events:
On 30 April 2013 at about 3:10 an incident happened in room (b) (7)(F)
(b)
Lab (7)
floor in the FMD area. A 96 well plate caught on scientists sleeve as they were adding another
(F)
plate to the incubator. The plate described above fell to the floor and landed right side up with the lid
slightly ajar. The majority of the media (EMEM, virus dilution, and cells) were still in the plate. Paper
towels were sprayed with a saturating quantity of 10% bleach and placed on top of the spill for a
minimum contact time of 20 minutes. The plate and towels were then autoclaved. An expanded area
was bleached again and those paper towels were also autoclaved. The area that contained the spill was
approximately 1 square foot.
At approximately 15:20 the ARO was notified of the incident by the scientist. They discussed
decontamination and spill containment procedures. There was no need for the scientist to report to the
FOH clinic as this was not a zoonotic agent and there were no injuries. The spill was contained and
decontaminated effectively. There was minimal likelihood that the spill aerosolized to a much larger
area as the lid was still covering the plate and there was a very small amount of liquid from the plate.
Section 3
Internal Review of Procedures: In accordance with the PIADC Biological Safety and Security Plan we
have initiated an internal review of the procedure summarized below:
1. The scientist maintains strict prohibition in accordance with the PIADC Personal Recognizant
Quarantine from visiting locations where susceptible livestock are housed during the
required period.
2. We have reviewed our internal procedures for use of Personal Protective Equipment;
Incident Notification, Spill Response and have found them to be current with no relevant
changes warranted.
Hazards posed by release:
None with qualification. Foot-and Mouth Disease Virus is not zoonotic,
therefore not infectious to humans with no potential for amplification outside of the enhanced BSL-3
laboratory. The employee performed standard personal decontamination according to facility protocol.

 The employee is maintaining personal recognizant quarantine. The spill was inside an enhanced BSL3
laboratory space with HEPA filtration of both the supply and exhaust ventilation.
Estimated extent of release or exposure:
Minimal to none with qualification. Foot-and Mouth
Disease virus is not zoonotic, therefore not infectious to humans with no potential for amplification
outside of the enhanced BSL-3 laboratory. The employee performed standard personal
decontamination according to facility protocol. The lid remained on the 96-well plate with a few
droplets escaping to the floor. The area was immediately covered with a saturating quantity of 10%
bleach and paper towels to minimize aerosol spread and facilitate decontamination. The spill was inside
an enhanced BSL3 laboratory space with HEPA filtration of both the supply and exhaust ventilation. The
employee is maintaining personal recognizant quarantine according to facility policy.
Area was decontaminated:
The area was immediately covered with 10% bleach and paper towels to
minimize aerosol and effect decontamination. Paper towels were saturated with 10% bleach for a
minimum contact time of 20 minutes. The plate and towels were then autoclaved. An expanded area
was bleached again and those paper towels were also autoclaved. The area that contained the spill was
approximately 1 square foot.
Medical treatment was provided:
There were no injuries and no medical treatment provided.
Foot-and Mouth Disease virus is not zoonotic, therefore not infectious to humans with no potential for
amplification outside of the enhanced BSL-3. Staffs are required to perform a personal decontamination
shower prior to leaving the facility.

 Needle Stick
Select Agent: Foot-and Mouth Disease Virus (FMDV)
Characterization of Agent:
1. A24 2. Recombinant replication-defective human adenovirus
serotype 5
Quantity:
0.5 ml
Name of agencies or local authorities notified: The PIADC Biosafety Officer and Responsible Official
notified using established procedures. The Nurse Practitioner was notified and attended to the
employee. The USDA Medical Review Officer notified by the nurse. RO notified Agricultural Select Agent
Service by email.
On 3/5/14 at approximately 1100 (b) (6), (b) (7)(F)
Detail Summary of Events:
was performing challenge inoculation on a pig vaccinated with recombinant replicationdefective human adenovirus blue serotype (b) (5)
vaccine. The challenge virus
(b) (5)
contained FMDV
The employee was performing heel bulb inoculation on an anaesthetized and
restrained pig and during the first inoculation the pig jumped, a normal response, and the syringe left
the pig heel and entered the employee’s finger. Initially the employee squeezed (b)
finger to expel
(6)
blood and finished the inoculation. Upon completion of the inoculation, the employee removed (b)
(6)
(b) (6)
gloves, disinfected the area with ethanol and bled
finger more. Prior to inoculation, the animal’s
heel was cleansed with ethanol. The employee was wearing appropriate PPE and clothing including;
tyvek, boots, double gloves and face shield. The employee performed appropriate personal
decontamination procedures. The employee waited until the next day, 3/6/2014, to notify(b)
first line
(6)
supervisor who waited until 3/7/2014 to notify the Research Leader who instructed the employee to
visit the occupational health nurse. The Research Leader notified the Biosafety Officer and Center
Director who notified the Responsible Official at approximately 6:15 PM on 3/7/2014.

(b) (6), (b)
(7)(F)

The Occupational Health Clinic was closed by the time the employee visited and an appointment was
made for her to visit with the Occupational Health Nurse the following day, 3/8/2014
Exam was unremarkable and employee denied any unusual signs and/or symptoms. Employee
instructed to follow-up with the clinic on Monday of the next week.
Section 3
Internal Review of Procedures: In accordance with the PIADC Biological Safety and Security Plan we
have initiated an internal review of the procedure summarized below:
1. The employee was referred to the Federal Occupational Health Clinic for an evaluation by
the clinic’s nurse in collaboration with the USDA Medical Review Officer.
2. The employee maintains strict prohibition in accordance with the PIADC Personal
Recognizant Quarantine from visiting locations where susceptible livestock are housed
during the evaluation period.

 3. The medical examination was unremarkable and the employee was directed to follow-up
with daily temperatures for a week.
4. We have reviewed our internal procedures for use of Personal Protective Equipment,
Incident Notification, Animal Handling, and Sharps and have found them to be current with
no change warranted. However, the employee and supervisor were trained on the proper
procedures for incident notification for occupational exposure and theft, loss, and release of
a select agent.
None with qualification. Foot-and Mouth Disease Virus is not zoonotic,
Hazards posed by release:
therefore not infectious to humans with no potential for amplification outside of ABSL-3 providing that
appropriate topical decontamination of the body area is taken. The employee is maintaining personal
recognizant quarantine and continued follow-up with the medical review officer.
None with qualification.
Estimated extent of release or exposure:
Foot-and Mouth Disease Virus is not zoonotic, therefore not infectious to humans with no potential for
amplification outside of ABSL-3 providing that appropriate topical decontamination of the body area is
taken. The employee is maintaining personal recognizant quarantine and continued follow-up with the
medical review officer.
The affected area was squeezed until blood was expressed and then
Area was decontaminated:
scrubbed with ethanol prior to leaving the Animal Isolation room. The employee exited the ABSL-3
facility using established personal decontamination procedures. When animal isolation rooms are
vacated the rooms are washed from floor to ceiling with carbochlor and then 2% Virkon.
Medical treatment was provided:
The employee reported to the PIADC occupational nurse two
days after the incident happened. The wound was unremarkable and showed no signs of infection. The
employee was instructed on signs and symptoms of infection and instructed to follow-up with the nurse.
At the time of initial visit there was no indication for prophylactic medication.

 {azardous Material Spills 2013-2014
3/1 8/ 14 ?Spill of Trizol Reagent?

. rizol Reagent Spill of approximately 250m]. The product is
used during protein extraction. See attached for
additional information.



?V?Number: 0618M - ENV

Date Time of Discovery: 3/18/14 1312 Hours

Noti?cation Only

PIADC
ONFO

Plum Island Animal Disease Center, Plum island. NY













Date Time of Noti?cation: 3/ l8/l4 1400 hours













EMS was Activated Health Safety Incident" Property Damage Reported"



Details of Nonconformance: (iv?hat, when, where, why)

Spill of Trizol Reagent in Lab 437. Spill by USDA personnel of approximately 250 ml of Trizol Reagent in Room 437
during lab clean-up.



Actions Taken:

Fire Brigade and environmental personnel responded. EOC opened and DHS noti?ed. Spill mitigated by ?re brigade.
Waste materials handled by environmental personnel. Room secured for overnight period to allow venting. Floor
cleaned with soap and water in the morning in accordance with best practices for phenols. See attached for more
information























Print Name of Reporter: (0) (6). (9) WW) Signature 01? Reporter:
Print Name of Supervisor: (0) (6). (0) WF) Signature ofSuperviso .
Print Name of Project Manager: Signature of Project Manager
Additional Comments:
This area to be ?lled out at PIADC Functional Meeting
Affected Administration (A) [j Bio-Safety/Bio-Security (BS) Buildings Grounds (BG)



Operation: Environment (ENV) Fire Activation (F) [3 IT (IT)
8 Lab?101 (L) Personnel/Physical Security(PS) Quality Assurance (Q)
2] Safety Health*(S) Transportation (T) Utilities (U)
Engineering (B) Bio-Surety (BY)
Other
Apparent/ [JDesign/Engineering Problem (DSGN) Equipment (EQPT) Personnel Error (PERS)

Contributing DManagement Problem (MNGT)
_Cause(s)_ DExtemal Phenomenon (EXTL)

Communications (COM) Training De?ciency (TRNG)
Procedure Problem (PROC)

















Response: Follow Up Required iWhat?I After action report
Work Order By Whom?
No Further Action Date_Closed:
PCAR





?For Health Safety, notify Occupational Health Nurse and DHS Safety Of?cer
See escalation thresholds in SOP-QA-003-O
Rev.02 2Augl3



Building 100 101 102 Hazardous Material Spills 2013?2014
3/20/14 Liquid Spill Building 101 ?Mod 1 hallway

0 Amount of liquid spilled was approximately 500 ml and was identi?ed as
a liquid containing E.coli DH5 alpha non-hazardous waste. See attached
NCR for additional information.

PIADC
NONCONFORMANCE REPORT

Plum Island Animal Disease Center, Plum Island, NY







?Number: 0310M ENV













Date Time of Discovery: 03/20/14 1850 Date Time of Notification: 03/20/14 1910







Noti?cation Only EMS was Activated DHealth Safety Incident? Property Damage Reported?



Details of Nonconformance: (what, when, where, why)
2222/Haz-Mat spill discovered by, 8101 outside Mod I in corridor.



Actions Taken:

FD activated. Fluid (th) from shaker unit (Innovo 4000) ?uid vessel. Contact Dr. ReSponsible for unit to ID ?uid. FD
mitigated spill as directed.
Notify PM2 whom made additional upper DHS noti?cations.



Print Name of Reporter: (0) (6). (NF) Signature of Reporte





Print Name of Supervisor: (0) (6). Signature of Supe





























Print Name of Project Manager: Signature of Project . 2--
Additional commentsAffected Administration (A) Bio-Safety/Bio-Security (BS) [3 Buildings Grounds (BG)
Operation: Environment (ENV) Fire Activation (F) IT (IT)
EH Lab -101 (L) Personnel/Physical Security(PS) Quality Assurance (Q)
Safety Health*(S) Transportation (T) Utilities (U)
Engineering (B) Bio-Surety (BY)
El Other
Apparent] DDesign/Engineering Problem (DSGN) Equipment (EQPT) E?Personnel Error (PERS)
Contributing [:IManagement Problem (MNGT) Communications (COM) [3 Training De?ciency (TRNG)
Cause(s) DExternal Phenomenon (EXTL) El Procedure Problem (PROC)
Response: El Follow Up Required What?
Work Order By Whom?
No Further Action Date Closed: /1 of
PCAR











*For Health Safety, notify Occupational Health Nurse and DHS Safety Of?cer
See escalation thresholds in SOP-QA-003-O
QA-003-1 Rev.02 2Augl 3





gig Gemini-,1:







Building 100 101 102 Hazardous Material Spills 2013-2014



12/05/13 -?Battery Acid Spill? Building 100 ?Auditorium

0 Battery backup for computer system overheated causing the
battery case to separate, allowing for battery acid to spill. See
NCR.

PIADC
NONCONFORMANCE REPORT

Plum Island Animal Disease Center, Plum Island, NY



Number:















Date Time of Discovery: 12/5/13 0915 Date Time of Noti?cation: 12/5/13 0915







Noti?cation Only EMS was Activated  Health Safety lncident? Property Damage Reported?



Details of Nonconformanee: (what, when, where, why)
Acid Spill? Several ounces of acid spilled from computer system back-up battery in the auditorium



Actions Taken:
FD and Hazmat response. Acid neutralized and cleaned up. Affected battery and parts to be disposed of as haz waste

Print Name of Supervisor: Signature of Supervisor:

Print Name of Project ManageW Signature of Project Maria






































Additional Comments:
This area to be ?lled out at Functional Meeting .
Affected Administration (A) (BS) I ?nildings Grounds (BG)
Operation: 8 Environment (ENV) Fire Activation (F) IT
CI Lab -lOl (L) El Personnel/Physical Security(PS) [3 Quality Assurance (Q)
Safety Health*(S) Transportation (T) [3 Utilities (U)
Engineering (E) Bio-Surety (BY)
Other
Apparent/ DDesign/Engineering Problem (DSGN) Equipment (EQPT) Personnel Error (PERS)
Contributing DManagement Problem (MNGT) Communications (COM) Training De?ciency (TRNG)
Causc(s) DExtemal Phenomenon (EXTL) Procedure Problem (PROC)
Response: Follow Up Required What?
Work Order By Whom?
No Further Action Date Closed: DEC 13313
PCAR





*For Health Safety, notify Occupational Health Nurse and DHS Safety Of?cer
See escalation thresholds in SOP-QA-003-0
Rev.02 2Aug13



1 February, 2013

MEMORANDUM FOR:

Record

REFERENCE: Incident summary-bite

On 2/1/13 at approximately 1400 a Foreign Animal Disease Diagnostics Course
student who was in the African Swine Fever
was nipped by a pig while
wearing tyvek and her skin was pinched. She stated there was a scant amount of
blood on the inside of her tyvek suit. The tyvek was examined carefully and noted
to be intact. The affected area was scrubbed immediately with betadine and ice
was applied.
(b) (7)(F)

At approximately 1445 the student was seen by the Nurse Practitioner in the
Clinic and the area noted to be ecchomotic with a minor abrasion. The Nurse
Practitioner cleansed the area with betadine and ice was applied. The NP
contacted the MD Consultant who ordered blood testing for Rabies Titer which
was done and sent to the lab. Bacitracin was applied to the affected area and a
loose dressing was applied.
The Student returned to the Clinic on 2/4/13-2/7/13 for daily evaluation and
treatment with patient teaching and the area had no evidence of infection and
healed well.
On 3/7/13 the Rabies Titer results returned and the end point titer vaccine
response was adequate and the student was notified and copies of the results
were sent to her.

Incident Summary
1 February 2013
FOR OFFICIAL USE ONLY