minutes recombinant dna committeeattending: lanford, pantusa, shade, anderson, randall-hlubek,...

Minutes Recombinant DNA Committee

Robert E. Lanford, Ph.D., Chair Victor Pantusa, EHS Director Robert Shade, Ph.D. Tim Anderson, Ph.D. Marie-Claire Gauduin, Ph.D.

Deborah Randall-Hlubek, MA Ellen B. Kraig, Ph.D. UTHSCSA David Kolodrubetz, Ph.D. UTHSCSA Scott Patlovich, EHS

Meeting Date: 3-7-2013 Time: 10 am Location: Texas Biomed Moody Conference Room Attending: Lanford, Shade, Brasky, de la Garza, Hayhurst, Anderson, Barnes, Gaudin, Pantusa, Patlovich Absent: The meeting was called to order on time. No new applications had been submitted for review. The meeting was mostly dedicated to new business and training. Membership. The committee welcomed Scott Patlovich as a new member. Dr. Lanford summarized the experience Scott Patlovich brings to the institute and the committee. He is the new TxBiomed Safety Manager and Select Agent Program Alternate Responsible Official when Victor Pantusa is not available. He is finishing up his Doctorate in Public Health in Occupational and Environmental Health Sciences He has a MS in Public Health in Occupational and Environmental Health He has a BS in Environmental Health He has several Certifications and Licenses: Certified Biological Safety Professional (CBSP) American Biological Safety Association Specialist Microbiologist in Biological Safety Microbiology (SM NRCM) National Registry of Certified Microbiologists Changes in review process and forms. Dr. Lanford suggested we add a dual use check box to the form

and circulated the form used at UTMB for discussion. It was suggested that the form from UTHSCSA be

circulated for review at the next meeting. Everyone agreed that the application form should contain a

check box for Dual Use.

Scott Patlovich had prepared information on modifying the Recombinant DNA forms for synthetic DNA.

The presentation from the OBA will be circulated as well as changes to the form.

Training- review TxBiomed suggested training for rDNA, also to be reviewed by Biohazard, additional

modules for Committee, PI, lab personnel (how inclusive).

New forms for spill response and laboratory signage were circulated for approval at the next meeting.

These were prepared by Scott Patlovich and Victor Pantusa.

The ongoing effort to get all applications older than 5 years was discussed. The update indicated that

only a few PIs had outstanding applications. The committee suggested a notice for 30 days for response

on intent to renew, and renewals staged over the next 60 to 90 days to spread review burden.

Plans to circulate the Institutional questionnaire form to all investigators & veterinarians was discussed.

This will capture scope of work in all labs. Initiate inspection of all labs. A updated Lab inspection form

will be circulated for approval. The new questionnaire will go out after all applications have been

renewed on the new form.

The meeting was adjourned.



Deborah Randall-Hlubek, MA Ellen B. Kraig, Ph.D. UTHSCSA David Kolodrubetz, Ph.D. UTHSCSA Scott Patlovich,

Meeting Date: 6-19-2013 Time: 10:00 Location: Texas Biomed Hixon Conference Room Attending: Lanford, Pantusa, Shade, Anderson, Randall-Hlubek, Kolodrubetz, Gaudin, Kraig, Absent: Patlovich The meeting was called to order on time. Applications Reviewed. 13-015 RDC Giavedoni SIV Chlamydia Flu Vaccinia

Do to concerns over Flu and Chlamydia this application was deferred. See minutes of 8-15-13 for final

revision.

Reviewer 1 1. This application looks good for the most part. However, it is written on the old (2012) version of

the form, and thus there are questions that he has answered which reflect incorrect citations from the NIH Guidelines (for example, see pages 2 & 3, questions 4, 5 & 6). There are also some remaining incorrect citations to the NIH Guidelines in the table. I’ve made some corrections in the edited attachment.

2. He will needs to verify the A/BSL-2+ precautions that are described within the protocol. I

believe he has what is needed in place, but this should be verified.

3. He needs to enroll his lab staff to the semi-annual blood draw schedule to ensure everyone is covered as stated in this and the Biohazards Committee application.

Reviewer 2

4. Before approving Dr. Giavedoni's application, I need more information on the "recombinant

Chlamydia trachomatis" he may be using. Making recombinant Chlamydia is a recently developed protocol. Depending upon the drug resistance marked used to select for DNA getting into Ct and the strain used, one may actually need to get special permission from NIH to make the recombinant and it may require BSL3 (not BSL2) conditions. I know the application states that the Chlamydia being used is attenuated, but I need more information (strain name and reference for data showing the strain is attenuated; antibiotic resistance gene used to select for Ct cells with vector DNA in them).

Reviewer 3

5. Please ask the PI to clarify the last sentence, or perhaps rephrase this sentence. “Macaque vaccinations and challenges with SIV will be performed in ABSL-2 facilities with ABSL-3 practices”. Regarding PPE, BSL-3/ABSL-3 requires the following:

“Whenever potentially infected animals or tissues are in the BSL 3 laboratory and not contained in BSCs, all persons must be provided with (and required to wear) a HEPA-filtered respirator. This respirator provides protection against both liquid and solid aerosols. The respirator must be NIOSH certified and fit tested by EHS.”

6. This rDNA application lists e.colli, influenza, VV, chlamydia and SIVmac. The IACUC application referenced only has approval SIV and Flu. It appears that the IACUC application may need to be amended.



Deborah Randall-Hlubek, MA Ellen B. Kraig, Ph.D. UTHSCSA David Kolodrubetz, Ph.D. UTHSCSA Scott Patlovich,

Meeting Date: 8-15-2013 Time: 10:00 Location: Texas Biomed Hixon Conference Room Attending: Lanford, Pantusa, Shade, Anderson, Randall-Hlubek, Kolodrubetz, Gaudin, Kraig, Absent: Patlovich The meeting was called to order on time.

Review of all applications greater than 5 years. The committee reviewed the progress of the effort to

get all older applications renewed or inactivated. This process is now complete all applications have

been renewed.

The format of the current form was discussed. EHS and the Recombinant DNA and Biohazard Committees will work together to create a set of criteria for BSL2+ and BSL2 with BSL3 practices. These criteria will be placed in the form as the minimum for use of these designations. The Giavedoni and Hayhurst applications both use vaccinia. A discussion of who should be vaccinated and under what conditions pursued. The committee decided that naïve individuals should only receive the vaccine if working with a non-attenuated strain of vaccinia. This is consistent with the recommendations from several sources. The Hayhurst lab will consider using a different strain that is highly attenuated to avoid the issues of vaccination. Applications Discussed.

13-015 RDC Giavedoni SIV Vaccinia Approved

1. Considering the number of agents and the type of agents EHS will need to verify the A/BSL-2+ precautions that are described within the protocol. Understood. Please call Luis Giavedoni at x9603 to schedule a visit to the laboratory.

2. Before approving Dr. Giavedoni's application, the committee needs more information on the "recombinant Chlamydia trachomatis" being used. Making recombinant Chlamydia is a recently developed protocol. Depending upon the drug resistance marker used to select for DNA getting into Ct and the strain used, you may need to get special permission from NIH to make the recombinant and it may require BSL3 (not BSL2) conditions. The application states that the Chlamydia being used is attenuated, but we need more information (strain name and reference for data showing the strain is attenuated; antibiotic resistance gene used to select for Ct cells with vector DNA in them).

We are not asking for authorization to use Chlamydia trachomatis vectors anymore.

3. More information needs to be provided on the vaccinia being used. Strain, vectors, vaccination of staff etc. The Vaccinia virus strain is called Wyeth, also known as Ney York city Board of Health strain. It was one of the strains used during the worldwide smallpox eradication campaign. All the VV vectors are made with this strain, and the process of creating the recombinant viruses produces the inactivation of the VV thymidine kinase (TK) and hemagglutinin (HA) genes. These double recombinant viruses are much more attenuated in vivo than the parental virus. Vaccination with VV is offered to personnel working with the viruses; however, vaccination is voluntary and not recommended since the risks of complications with the vaccine strain are much higher than accidental exposure to the recombinant virus.

4. More information is needed on the influenza being used. Please provide information on the vectors, maps, etc. If it is being done outside, Texas Biomed will need copy of the recombinant DNA approval from that institute. Influenza vectors are not going to be used in these experiments.

5. Please clarify the last sentence, or perhaps rephrase this sentence. “Macaque vaccinations and challenges with SIV will be performed in ABSL-2 facilities with ABSL-3 practices”. Regarding PPE, BSL-3/ABSL-3 requires the following:

“Whenever potentially infected animals or tissues are in the BSL 3 laboratory and not contained in BSCs, all persons must be provided with (and required to wear) a HEPA-filtered respirator. This respirator provides protection against both liquid and solid aerosols. The respirator must be NIOSH certified and fit tested by EHS.”

Veterinary personnel who work with animals exposed to SIV wear proper PPE. Infected tissues from these animals that are manipulated in the BLS-2+ lab are contained in BSCs.

6. This rDNA application lists e.colli, influenza, VV, chlamydia and SIVmac. The IACUC application referenced only has approval for the SIV and flu. The IACUC application will need to be amended if the other organisms are used in animals. The IACUC application has already been amended. NIH Guidelines Used for Approval

Please Check all that apply in the boxes below: NIH Guidelines

reference:

a. Use of animal cells/cell lines or tissues (e.g. tissue culture research) II-A-3, Appendix C-1

b. Use of human cells/cell lines or tissues (e.g. Human blood, 293 cell lines, CSF) II-A-3

c. Use of or the cloning of genes from, or into a Risk Group 2, 3, 4 or restricted

agent III-D-1, 2

d. Use of virus or viruses III-D-3, III-E-1

e. Experiments Involving the Use of Infectious DNA or RNA Viruses or Defective

DNA or RNA Viruses in the Presence of Helper Virus in Tissue Culture Systems III-D-3

e. Propagating culture volumes exceeding 10 liters III-D-6

http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm

http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm

http://www4.od.nih.gov/oba/rac/guidelines_02/APPENDIX_C.htm

f. Creation of c-DNA/genomic libraries (Do not check if purchasing a ready-

made library) III-E, III-F

g. Cloning and vector construction in bacteria and yeasts III-E, III-F

h. Use of rDNA molecules for detection purposes (e.g. probes) III-F

i. Expression of rDNA products in cultured cells III-E, III-F

j. Experiments involving Whole animals Administration of rDNA material into

animals (e.g. transformed cells, vectors) III-D-4

k.

Experiments involving transgenic/knockout animals requiring ABSL-1

containment, III-E-3

Experiments involving transgenic/knockout animals requiring ABSL-2 and

above containment

l. Experiments involving whole Plants III-D-5

m. Experiments Involving Influenza Viruses III-D-7

13-016RDC Lanford Mol. Biol.Hepatitis Approved

1. Please consider requesting that the PI separate this renewal application into 2 renewal applications. Significant differences exist; which suggests that 2 applications should be created.

o Hepatitis A, B, C, D o GBV-B

The basis of the request is the difference between GBV-B and the human viruses HAV, HBV, and HCV.

Since GBV-B is nearly identical in genetic structure to HCV, we do not believe it should be separated

from the HCV in a recombinant DNA application. All genetic manipulations are similar with the two

viruses. The difference is that HCV infects man and GBV-B does not, but we handle both under the same

conditions, as BSL2 agents. HAV is actually the virus that differs the most from the other viruses, since it

can be transmitted by the oral route and thus poses an increased hazard. However as mentioned all

personnel working with HAV have been vaccinated.

2. There is a “typo” on page 6, next to the last sentence: Personnel work gloves, etc. versus wear gloves….corrected.

3. What is the procedures when using sharp objects or glasses when manipulating this virus? We use no glass when working with infectious agents, only disposable plastic. We do use sharps, needles for injection of animals and scalpels for dissecting tissue provided by the vet or pathologist. These are disposed of using sharps containers provided by EHS and returned to EHS after autoclaving. This was been explained in the application but has been expanded in the revised application on page 10, section 5.

4. With respect to exposure to contaminated blood and/or work surfaces. Everyone is immunized for HBV but are there some antiviral treatments available if someone is exposed to the other viruses? New antiviral cocktails for HCV can cure approximately 95-100% of individuals in 12 weeks. All personnel are vaccinated for HAV, but if exposure of an unvaccinated individual occurred, infection can be blocked by using hyperimmune globulin up to 2 weeks after exposure. The HBV vaccine protects for HDV, since HDV uses the HBV envelope for transmission. This information has been added to page 10, section 4.

5. All animals’ experiments will be performed at SNPRC in the ABSL-2. Will everyone be aware of the exposure risks? Are the animal's care staff and veterinarians vaccinated as well? All animal care workers working with chimpanzees are aware of the infectious status of the animals in each study. They are all vaccinated for HBV and thus also protected to HDV. For in vivo HAV studies, all SNPRC personnel entering the buildings during the infectious stage (animals were monitored for shedding and maintained indoors) were vaccinated for HAV. All SNPRC personnel are aware of the risk for HCV when working with chimpanzees. Since many animals on campus are chronically infected, all chimpanzees are handled as if infectious. This information has been inserted on page 10, section 4.

NIH Guidelines Used for Approval


reference:

a. X Use of animal cells/cell lines or tissues (e.g. tissue culture research) II-A-3, Appendix C-1

b. X Use of human cells/cell lines or tissues (e.g. Human blood, 293 cell lines, CSF) II-A-3

c. X

Experiments using Risk Group (RG) 2, 3, or 4, or Restricted Agents as host-vector systems; Experiments in which DNA from Risk Group 2, 3, or 4, or Restricted Agents is cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems

III-D-1, 2

d. X Experiments involving the use of infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of helper virus in tissue culture systems

III-D-3

e. X

Experiments involving whole animals in which the genome has been altered by stable introduction into the germ-line (transgenic animals) and experiments involving viable recombinant or synthetic nucleic acid-modified microorganisms tested on whole animals

III-D-4

f.

Experiments involving whole plants – genetically engineering plants by recombinant or synthetic nucleic acid molecule methods, using or propagating such plants, using plants with microorganisms or insects containing recombinant or synthetic nucleic acid molecules

III-D-5

g. Propagating culture volumes exceeding 10 liters III-D-6

h. Experiments involving Influenza viruses III-D-7

i. X Formation of recombinant or synthetic nucleic acid molecules containing no more than 2/3 of the genome of any eukaryotic virus

III-E-1

j. Nucleic acid molecule-modified whole plants and/or nucleic acid molecule-modified microorganisms associated with whole plants not covered in sections III-A, III-B, III-D or III-F

III-E-2

k. Generation of rodents in which the animal’s genome has been altered by stable introduction of recombinant or synthetic nucleic acid molecules, or nucleic acids derived therefrom, into the germline (transgenic rodents)

III-E-3

13-017 RDC Ruprecht Molecular cloning and expression of monoclonal antibodies and fusion proteins

Approved

1. Add "epitopes from HIV/SIV envelope proteins" to Table B.

2. Add plasmid vector names to Table A and explain vectors in the body of the text (eg commercially

obtained vectors, name).

NIH Guidelines Used for Approval


reference:

a. Use of animal cells/cell lines or tissues (e.g. tissue culture research) II-A-3, Appendix C-1

b. Use of human cells/cell lines or tissues (e.g. Human blood, 293 cell lines, CSF) II-A-3

c.

Experiments using Risk Group (RG) 2, 3, or 4, or Restricted Agents as host-

vector systems; Experiments in which DNA from Risk Group 2, 3, or 4, or

Restricted Agents is cloned into nonpathogenic prokaryotic or lower

eukaryotic host-vector systems

III-D-1, 2

d. Experiments involving the use of infectious DNA or RNA viruses or defective

DNA or RNA viruses in the presence of helper virus in tissue culture systems III-D-3

e.

Experiments involving whole animals in which the genome has been altered

by stable introduction into the germ-line (transgenic animals) and

experiments involving viable recombinant or synthetic nucleic acid-modified

microorganisms tested on whole animals

III-D-4

f.

Experiments involving whole plants – genetically engineering plants by

recombinant or synthetic nucleic acid molecule methods, using or

propagating such plants, using plants with microorganisms or insects

containing recombinant or synthetic nucleic acid molecules

III-D-5

g. Propagating culture volumes exceeding 10 liters III-D-6

h. Experiments involving Influenza viruses III-D-7

i. Formation of recombinant or synthetic nucleic acid molecules containing no

more than 2/3 of the genome of any eukaryotic virus III-E-1

j. Nucleic acid molecule-modified whole plants and/or nucleic acid molecule-

modified microorganisms associated with whole plants not covered in III-E-2

sections III-A, III-B, III-D or III-F

k.

Generation of rodents in which the animal’s genome has been altered by

stable introduction of recombinant or synthetic nucleic acid molecules, or

nucleic acids derived therefrom, into the germline (transgenic rodents)

III-E-3




Meeting Date: 10-24-2013 Time: 10:00 The meeting was called to order on time. Dr. Robert Lanford, Victor Pantusa and Scott Patlovich met to discuss revisions needed on the application forms. Currently the revisions for the application are in process, new application will begin being utilized once complete. No other information was discussed.


Robert Davey, Ph.D., Chair Victor Pantusa, EHS Director Robert Shade, Ph.D. Tim Anderson, Ph.D. Marie-Claire Gauduin, Ph.D.


Meeting Date: 3-20-2014 Time: 10:00 Location: Texas Biomed Hixon Conference Room The meeting was called to order on time. Items for discussion. Old items for discussion. Review of Applications. 14-020 to 14-021.

14-020 RDC Ruprecht – Construction of infectious molecular clones of SHIV and of HIV-1 expressing Renilla Luciferase. Comments and suggestions for revision

14-021 RDC Ruprecht – Generation of infectious virus from existing proviral DNA clones. Comments and suggestions for revision


Robert Davey, Ph.D., Chair Victor Pantusa, EHS Director Robert Shade, Ph.D. Tim Anderson, Ph.D. Marie-Claire Gauduin, Ph.D.


Meeting Date: 4-17-2014 Time: 10:00 Location: Texas Biomed Hixon Conference Room The meeting was called to order on time. Items for discussion. Old items for discussion. Review of Applications. 14-020 to 14-021.

14-020 RDC Ruprecht – Construction of infectious molecular clones of SHIV and of HIV-1 expressing Renilla Luciferase. OUTCOME: Responses met committee approval: Approved. 14-021 RDC Ruprecht – Generation of infectious virus from existing proviral DNA clones. OUTCOME: Responses met committee approval: Approved.

Recombinant DNA committee

Date | time 5/22/2014 10:00 AM | Meeting called to order by Robert Davey

In Attendance

Robert Davey (Chair), Tim Anderson, Scott Patlovich, David Kolodrubetz (by phone), Deb Randall-Hlubek, Katy

Freed. Absent were Marie-Claire Gauduin, Ellen Kraig (both out of town), Tara Edwards (Resigned)

Approval of Minutes

The minutes from the April meeting were approved

Discussion

Guidance on the regulation of select agent and toxin nucleic acids.

http://www.selectagents.gov/SyntheticGenomics.html

The document describes expansion of Tier 1 select agents regulations to materials in addition to

Botulinum toxin and Foot and mouth disease virus.

FSAP regulates select agent and toxin nucleic acids that are:

inherently infectious and are immediate precursors to virus production (i.e., the nucleic acids are capable of

generating infectious forms of a regulated virus by utilizing host polymerases but without the need for any

additional exogenous factors (proteins, nucleic acids, etc.)),

encode for the functional form(s) of any of the select toxins if the nucleic acids can be expressed in vivo or in

vitro, or are in a vector or recombinant host genome and can be expressed in vivo or in vitro, or

that have been genetically modified.

This mostly covers +ve sense stranded virus genomes.

Not included:

o Nucleic acids encoding complete genomes of single-stranded negative strand RNA viruses, double

stranded RNA viruses, and double-stranded DNA viruses that require a unique polymerase (Variola

virus*, Monkeypox virus (except West African clade), African swine fever virus, Goat pox virus,

Lumpy skin disease virus, and Sheep pox virus). These genomes are incapable of producing

infectious virus when introduced by itself into an animal or permissive cell without the introduction

of rescue plasmids or other exogenous factors.

o cDNA copies lacking host promoter elements.

Working with FSAP regulated genomes at lower containment

o This paragraph was deferred for committee members to interpret leading up to the next meeting. It

will be discussed up to that time.

Meeting will shift to 9 am on the 3rd Thursday of each month

All agreed.

http://www.selectagents.gov/SyntheticGenomics.html

Announcements

Scott Patlovich announced resignation from committee

Scott will be taking a position at the U. Houston as head of EHS. We wish him the best for his new job.

Tara Edwards resignation was announced

Tara has taken another job. A replacement is being sought.

Next Meeting

6/19/2014 9:00 AM, Hixon Conference room

The meeting was adjourned at 10.40 am.

Recombinant DNA committee


In Attendance

Robert Davey (Chair), Tim Anderson, David Kolodrubetz (by email), Katy Freed. Absent were Marie-Claire

Gauduin, Ellen Kraig (out of town)

Approval of Minutes

Victor Pantusa indicated that he was left off the attendance list in the May minutes. This was noted. The minutes

from the May meeting were then approved.

Discussion

Guidance on the regulation of select agent and toxin nucleic acids.

Brian Herman 14-022 RDC was discussed. The objective of the proposal is to have a baboon in which the sperm

are tagged with the green fluorescent protein so that treatments to cure male sterility can be tested. The

following comments were generated:

1. The project is to introduce a recombinant gene into the germ line of baboons. Males will be used and the

recombinant gene will be transduced into sperm producing cells. As such it is critical that all animals have

absolutely no contact with any female baboons and preferably no other baboons that are not part of the

project. Housing needs to be secure and provide no possibility of animals interacting with others such that

transgenic offspring could be generated.

2. How will the animals be isolated from other animals? What special precautions will be taken to maintain

3. In table 1, it is presumed that lentiviruses will be generated in human cell lines. If so, question b. should be

checked and use explained. If all lentivirus generation will be done at UTHSCA, then this can be omitted but

the approved recombinant DNA committee application from UTHSCA needs to be filed with the TxBiomed

Recombinant DNA committee.

4. In Agent information, Table A. Genus and species says “HIV-1” and RG-2. This is innacurate. You should

write, “3rd generation recombinant lentivirus expression system” or similar to make it distinct. Please

include a map of the gene inserted into the expression plasmid and describe what is packaged into the virus.

5. While it is stated that H2B is inert and not oncogenic, there is no description of what the protein is and why

it was chosen. This needs to be addressed.

6. As a general comment, the use of the generation 3 lentivirus vector is appropriate and carries limited

potential to deliver the gene to other cells once the transduced cells are implanted. The description of the

system is adequate but diagrams showing the constructs would be useful.

7. Assurance needs to be made that the animals will be euthanized at the end of the project.

8. For part 5, it is stated that “negligible amounts of lentivirus particles will be used at SNPRC”. While this

presumably reflects concern that residual virus is present, the washing and incubation procedures probably

eliminate most free virus. If so, it would be better to state that free virus will be washed free of cells and then

cells transferred to TxBiomed. An estimate of residual virus should be given.

Announcements

Email listing needs update

Tim Anderson indicated that he was not receiving email notifications. This will be corrected by R. Davey.

Next Meeting

7/17/2014 9:00 AM, Hixon Conference room

The meeting was adjourned at 9.50 am.

Recombinant DNA Committee


In Attendance

Robert Davey (Chair), Victor Pantusa, Deb Randall-Hlubek, Katy Freed, Marie-Claire Gauduin, Shelly James

Phone Conference: David Kolodrubetz, Ellen Kraig

Absent were: Tim Anderson

Discussion

Items for discussion:

Review of applications:

14-022 RDC There was concern as to why we were discussing what appeared outwardly to be an IACUC animal safety or animal

colony management issue. The concerns were:

This proposal was not relevant as the committee serves only for human biosafety, not animal safety.

However, NIH guidelines III-D4, page 19 states the committee needs to review “Experiments involving whole

animals which the genome has been altered by stable introduction to the germ line and experiments

involving viable recombinant or synthetic nucleic acids modified by microorganisms tested with whole

animals.”

It was agreed that the protocol did require review.

NIH Regulation links will be placed on the server for the committee. Shelly will add.

Re: 14-022 RDC Hermann – Culture and transplantation of baboon spermatogonial stem cells The PI met the conditions of the committee and the protocol was approved.

o OUTCOME: Voted approved.

Announcements

Shelly James is now the secretary of the committee.

Next Meeting

9/18/2014 9:00 AM, Moorman Conference room

The meeting was adjourned at 9:42 am.

minutes recombinant dna committeeattending: lanford, pantusa, shade, anderson, randall-hlubek,...

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