Living Resources Subcommittee
C. ariakensis Ad hoc Panel
Location: Potomac River Fisheries Commission

Colonial Beach, Virginia
Date: Monday March 12, 2007
Time: 10:00 AM - 3:00 PM

Conference Line: 410-305-3500 Ext.: 3520 Access Code: 6333

Minutes

Attendance:

Name

Email

Affiliation

Ron Klauda

rklauda@dnr.state.md.us

MD DNR

Mike Fritz

fritz.mike@eDa.aov

EPA

Julie Slacum

iulie thomDson@fws.aov

US FWS

Chris Guy

chris auv@fws.aov

US FWS

Genevieve Trafelet

trafelet.aenevieve@eDa.aov

CRC

Frances Porter

vscfwD@aol.com

VSC

Howard Kator

kator@vims.edu

VIMS

James Kirkpatrick

JLK0729@vims.edu

VSC

AJ Erskine

aierskine@bevansovster.com

BOC/CSC/VSC

Roger Mann

rmann@vims.edu

VIMS

Jack Travelstead

iack.travelstead@mrc.virainia.aov

VMRC

Peter Kube- phone afternoon

Peter.R.Kube@nao02.usace.armv.mil

ACOE

Stan Allen- phone afternoon

ska@vims.edu

VIMS

Jamie King- phone

iamie.kina@noaa.aov

NOAA

Jeff Tinsman- phone

ieffrev.tinsman@state.de.us

Delaware Fisheries

Stan Gorski- phone

stanlev.w.aorski@noaa.aov

NOAA Fisheries

Welcome, Introductions & Announcements

Ron Klauda introduced himself as the new Oyster Ad-hoc Panel (hereafter referred to as the
Panel) Chairman and gave a brief summary of his background and experience. He was
appointed to replace the former Panel Chair, Fred Kern, who retired. Ron mentioned that he is
not an oyster biologist of oyster fisheries manager, but he was involved in writing the 1993
Chesapeake Bay Policy for the Introduction of Non-indigenous Aquatic Species, the document
that describes the Ad hoc Panel review process.

Proposal A: Comparing microbiological characteristics of C. ariakensis and C. virginica
with respect to uptake and elimination of bacterial and viral pathogens

I. Proposal & Presentation of Data (Howard Kator, VIMS co-PI)

Dr. Kator gave a power point presentation on the proposed research project (copy is attached).
Project duration: 1 year (1 October 2006- 30 September 2007)

-Pis want to conduct their project in-situ because laboratory experiments have given inconclusive
results.

-They also want to investigate changes in vibrio concentrations during storage to compare shelf
life.

—The project would be conducted in both states because MD waters have lower salinities
compared to VA waters.

—Kator passed around NEPA submission (Appendix III, which was not included in the original
proposal).

—biosecurity measures that will be used were reviewed

—Fritz: Asked if they will have an actual count of all oysters used in the project for biosecurity
measures.

—Kator. Replied, yes, they will have a total count and stated that test oysters will be kept in onion
bags that will be labeled with the species name.

—Slacurrr. Asked what will be the average size of the test oysters deployed?


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—Kator. Replied that they will try for commercial size (3-4 inches)

—Guy. Commented that the reproductive risk for this project is probably very low.

—Kator: Explained the time frame of the study using Table 1. from his presentation. He noted

that the highlighted numbers have not been done yet; two replicates are done for each season;

and totals for the season are listed).

—Kator. Mentioned that oyster test cage deployments of STP and others cannot be concurrent
—Kator. Summarized oyster deployment needs for tests in MD Waters: The total for all studies in
Annapolis and Severn River will be 1700; but the maximum number deployed at any given time
will be 500 for all experiments.

Action: Genevieve will copy Kator's power point presentation and send it out to all Panel
members.

~ Panel Discussion/Q & A

Ron Klauda led a discussion that gave all Panel members a chance to voice their questions or
concerns to the PI regarding this proposed research project.

—? Tinsman: Inquired if the Pis have seen any surprising results between C. ariakensis (Ca) and
C. virginica (Cv) in previous or current research projects.

—Kator. Replied, yes. Ca takes up more pathogens and eliminates them more slowly than Cv
for Frna colifage (based on two experiments in fall 2006), but he doesn't know what will happen
in other experiments.

—? Tinsman: Asked if these results will cause them to re-think their water sampling protocols ?
—Kator. Replied that they may affect how they are stored. There are differences in how they do
under different conditions. No norovirus data are available right now; samples have not been run
yet.

—Kathy Brohawn (MDE) comment submitted 3/16/07 via email: All species of molluscan shellfish
(oysters, clams, mussels, and scallops) can be harvested for human consumption from waters
classified as approved in accordance with the National Shellfish Sanitation Programs (NSSP).
Deployment of C.a. would not impact water sampling protocols (example: same protocols for C.
gigas on the Northwest coast, blue mussel, soft shell clams, etc. on the Atlantic coast).

—Fritz: Asked if the Pis have applied for permits from MD and VA state agencies to carry out this
proposed project?

—Kator. Stated that permits were issued for VA by VMRC. Ken Paynter will seek the
appropriate MD permits. They were not sure of the protocol.

—Fritz: Reviewed the protocol for submitting proposals and who should be involved in the
process along the way. Asked if MDE was the permitting agency for MD.

—Kator. Said he talked to Kathy Brohawn (at MDE). She said the proposed project will need an
aquaculture permit.

—Klauda: Agreed to determine if DNR is the appropriate permitting agency for MD and who the
DNR contact person is [on 3/15/07, Klauda confirmed that MDE is the MD permitting agency
(Rick Ayella) for research projects involving in situ experiments with ariakensis. Permit
requests received by MDE for a proposed project like the Kator et al. experiment will be
forwarded to DNR's Environmental Review group for comment. If the procedures for an
Ad hoc Panel review of a project like the Kator et al. proposal are followed as described in
the 1993 Bay Policy document, Rick Ayella would forward the proposal to Matt Fleming at
the same time he forwards it to DNR for comment].

—Chris Judy (DNR) comment submitted 3/16/07 via email: In-the-water work requires permits
from MDE and the MD Corps. Application forms are available from MDE by contacting Rick
Ayella's office (410-537-3835) or http://www.mde.state.md.us/assets/document/permit/alter sf.pdf
The form is a joint application that the Corps also uses, so a copy only needs to be submitted to
MDE who will then provide a copy to the Corps. One reason a permit is need is because the gear
that the oysters is a structure placed in the water ("fill"). The MDE permit goes to the MD Board of
Public Works for final review. If the BPW approves it, then MDE issues the permit. An
Aquaculture Permit is not needed from MD since the MD trial being considered here is not
aquaculture. An Importation Permit is required from MD DNR if oysters are being shipped in to
the State and placed in the Bay. Contact Rich (410-260-8317) who is also the Aquaculture Permit


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contact. For additional information:

http ://www.mde.state. md.us/Permits/WaterManaqementPermits/water2.asp#3.16
— Kathy Brohawn (MDE) comment submitted 3/16/07 via email: Pis should note that the permit
process is very lengthy and can take 3-6 months to complete depending on the project. Pis
should apply for a Wetlands License from MDE ASAP.

—Slacurrr. Mentioned that the Rivers and Harbors Act requires a permit if you have a structure
out in the water. Agreed that the permitting process can be confusing for Pis what permits are
needed for projects; stated the need for a standard procedure. Observed that the caged study by
Luckenbach and field experiments conducted by Breitberg and Paynter were reviewed by the
Panel and required a state and Corps permit.

—Klauda: Restated the 1993 Policy procedures that state Pis should submit their research
proposals involving in situ testing with Ca to the appropriate state agencies, whom would then
pass the proposals on to the Panel, via the Living Resources Subcommittee, for review and
recommendations.

—Fritz: Added that the Panel is supposed to provide comments on each research proposal and
submit their report to the permitting agencies. Need to clearly identify the contact person at each
permitting agency.

—Fritz: Asked Kator if they have had any biosecurity issues so far?

—Kator. Replied, no, they have not.

—Guy. Commented he doesn't think that, given the relatively small numbers of Ca that would be
used in the proposed research project, there is a significant risk of reproduction; but also
emphasized that the proposed project would offer three spawning opportunities for the Ca test
organisms, and there have been Ca deployment projects in the same location previously. This
raises a question of cumulative reproductive risk.

—Kator. Stated that they did not run the cumulative reproductive risk model during preparation of
their proposed research project.

—Siacunr. Stated that it would be useful to map all test locations and gather together data on
deployment periods, test oyster numbers, etc of all research projects previously reviewed and
approved by the Panel.

—Guy. Pointed out that multiple tests and Ca deployment in same general area brings up the
important issue of geographic isolation.

—Klauda: Asked if running the reproductive risk assessment model should be the responsibility
of the Pis proposing this research project or the Panel?

—Guy. Answered that the risk model should be used as a scientific tool. But who should run the
model for this proposed project should be a Panel decision.

—Siacunr. Commented that the risk model was used in the Breitburg and Luckenbach
experiments and was a factor in the Panel decisions on these projects. Stated that we need to
have a better idea of how reproductive risk is accumulating as more and more oysters are
deployed in various research projects.

—Kator. Stated that only one tray of Ca and one tray of Cv will be deployed at any given time
period at their test site locations.

—Guy. Stated the oyster gametes will not likely be viable if the test animals are further than one
meter apart. The risk model can predict F2 generation from trials and Panel shouldn't accept 2 or
more diploids from model output for any proposed deployment of Ca. Diploid rate is 3 in 10,000.
Would be worthwhile to run the risk model to assess risk overall.

—King: Concurred with Guy and suggested that the Panel ask the Pis to run the risk model with
their proposed experiments along with other experiments that were conducted in the same
tributary. She pointed out that VSC has extensively used the risk model in their proposals;
therefore, for consistency, it makes sense to ask the Pis for this proposed research project to also
run the risk model and provide these results to the Panel.

*Recommendation: All experiments should remain under a threshold below 2 diploid adults
across all experiments conducted in the same tributary.

—Fritz: Asked who should have the burden of running the risk model? He suggested that the
permitting agency should be involved. He quoted the 1993 Policy (page 5),"....agency will review
the risk...", so the burden falls on the permitting agency for reviewing the risk as well. Applicants
can continue to use the model with the Panel's oversight.


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—Klauda: Recommended that the permitting agency ask the Pis to run the model and report on
model results when they submit their research proposal for approval and permits.

— Kathy Brohawn (MDE) commented submitted 3/16/07 via email: She does not agree with this
recommendation that the permitting agency ask the Pis to run the model. There is too much
uncertainty in the scientific validity of the model. She does agree that those represented on this
Panel have a comfort level with the use of the model that is important for this discussion and can
result in suggested risk reduction activities, but she does not feel comfortable about making this a
requirement for the permit application. Permitting agencies should have enough information for
"...reviewing the risk".

—Tinsman: Concurred with the recommendation for this particular research project, but does not
feel confident in relying on the reproductive risk model solely for making decisions on proposed
deployments. When large numbers of non-native oysters are involved and many experiments are
repeated in the same place, the model cannot fully assess the cumulative risk.

—Slacurrr. Commented that the proposed research project is a small scale trial that will not be
repeated in the same place year after year. The risk is negligible compared to the value of the
information that will be gained from this experiment. It is important to have biosecurity plans and
to run the risk model. She does not think that cumulative risk assessment is as important for small
scale experiments like this one.

—Guy. Stated that, to be consistent, the reproductive risk model should be required for all
proposals requesting approval to deploy Ca in-situ.

—Slacurrr. Stated that even though Breitburg, Paynter and Luckenbach were not required to run
the cumulative risk model, they did it on their own. The Panel should ask Katorto run the risk
model for this proposed research project.

—Klauda: Asked if the Pis should be required to remove all Ca at the end of their experiments
and count any losses so they would know if any Ca are not accounted for.

—Guy. Answered that the risk model does not consider escapement (which is this question)
—Klauda: Asked the PI what would stimulate them to go out and pick up their baskets in case of
bad weather?

—Kator. Replied that a hurricane would definitely be one condition that would cause them to
remove their test baskets from the test sites. Forecast of a strong Noreaster would not stimulate
them to remove their baskets. The STP site is relatively shallow. Test oysters will be deployed
from floats and anchored with PVC pipes. PVC is used around the top of the containers; this fills
with sediment which weighs the container down.

—Slacurrr. Asked if the Pis have had any issues with people disturbing their experiments?
—Kator. Answered, no, not when in the buffer zone. A float identifies where their test containers
are located in VA waters. He cannot speak for how Ken Paynter sets up his experiments in MD.
—Klauda: Asked for more insight from the Pis in their biosecurity protocols on what would
stimulate test cage removal besides a hurricane. Asked if they has any in-situ experiments going
during Hurricane Isabel (Sept. 1993).

—Kator. No cages were out prior to Isabel in 2003.

—King: Recalled that there have been spills from oyster baskets/cages due to wave action. Ken
Paynter has possibly had a documented spill at Chesapeake Biological Lab in Solomons.
—Tinsmarr. Remarked that a spill may have happened at Paynter's own dock at Solomons
Island.

—King: Commented that storms less than hurricane strength have caused some loss or escape
of oysters; especially in shallow waters. But, she wanted to emphasize the point that there
should be a distinction between small scale research projects and larger scale, commercial
experiments. There is also a need to consider the value of the information that will be gained by
an experiment. This proposed research project will provide really significant information regarding
human health risk and this should be considered. A negligible level of risk should be outweighed
by the information that is gained.

—Fritz: Asked if cumulative risk should be addressed with other places in the vicinity. We need
to get this information on a map so we know what is going on and where. This should be a
consistent policy. Previous in situ experiments are part of the existing environment, so they
should be included in the risk model.

—Guy. Commented that the reproductive risk model is easily applied.


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Action- Chris Guy will serve as a technical resource to assess reproductive risk associated with
this experiment and whether other research experiments conducted in the Severn could
contribute to a cumulative risk issue.

~ Review of Seven Criteria and Responses

(i) purpose and usage of proposed introduction

Proposal:

The overall objective of the project is to characterize the uptake and elimination of
indicator microorganisms and pathogens from C.ariakensis and C. virginica contaminated in situ.
The following are sub-objectives of the project:

a)	measure the uptake and elimination of fecal indicators and pathogens following in situ
contamination of both oyster species in Virginia and Maryland;

b)	measure and compare the densities of selected Vibrio spp. in both oyster species harvested
from grow out areas in both Virginia and Maryland.

c)	measure changes in Vibrio spp. concentrations during storage of both oyster species under
typical harvesting and commercial refrigeration and assess shelf life.

—Kathy Brohawn (MDE) comment submitted 3/16/07 via email: As a point of clarification, Vibrios
spp. are naturally occurring organisms in surface waters worldwide and are not due to pollution
sources. Maryland does not typically harvest oysters in the summer when vibrio levels are high.
Not all vibrios found in the water column or in shellfish are pathogenic to humans. One of the
study sites is within a closed buffer zone of the Annapolis waste water treatment plant. Harvest
prohibited from this location and would not be reflective of typical harvest.In addition, harves
would not even be permitted for relay (natural cleansing) or depuration (not currently practiced in
MD or VA) from this site.

Oyster Ad hoc panel comments:

There was general agreement that the purpose and usage of this proposed introduction
has merit and will provide important information regarding human health risks associated with
consumption of uncooked Ca.

—Kathy Brohawn (MDE) comment submitted 3/16/07 via email: From her understanding of the
proposed study, it will not provide important information regarding human health risks associated
with consumption of uncooked C.a. Rather the study will provide a picture into natural cleansing
rates associated with product (C.a. compared with C.v.) that is harvested from unapproved
waters and moved to approved waters, prior to being harvested for human consumption. Again,
this is strictly prohibited from STP buffer zones. As stated in my earlier comment, regardless of
species, shellfish harvested from approved waters are allowed to be sold for human consumption.
This project may answer questions related to relay. Also, temperature control post-harvest has
been effective in reducing vibrio levels in oysters harvested on all coasts, including C.gigas on the
west coast. This information would be very useful for both C.v. and C.a. if there is move to more
summer harvest in our region. It should be understand that there is a risk associated with eating
raw shellfish of any kind, even from approved waters. People who are immunocompromised
should always avoid eating raw shellfish.

—Kator comment submitted 3/19/07 via email: You are correct that the proposal as written will
not provide direct information on actual human health risk from consumption of shellfish
(regardless of species) harvested under NSSP conditions. And for that matter the current NSSP
guidelines regulating harvesting of shellfish are not based on actual human health risk data. The
proposal merely seeks to compare two species of shellfish using one, C. viriginica, as "baseline."
If significant differences in uptake/elimination rates between shellfish species are observed for
viral indicators or pathogenic viruses, then one could hypothesize a human health risk could be
more (or less) likely with one species than with the other. One could then modify relay
parameters (as you mentioned), seasonal harvest periods or even distance from known
contamination sources. As I mentioned at the ad hoc panel meeting, our results thus far suggest
that under similar field conditions, C. ariakensis takes up a higher level of indicator virus and
retains it for a longer period than C. virginica.


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This proposal is designed to establish a comparative species "baseline" by describing
the basic uptake/elimination behavior and vibrio burden when C. ariakensis and C. virginica are
challenged under the same field conditions. To establish this baseline it is necessary to insure
levels of natural contamination are high enough to "see and follow" elimination overtime. For
human pathogens, natural contamination within a buffer zone provides the most effective means
to achieve this condition. And yes, harvesting or relay from within a buffer zone is not permitted.

Similarly, the question has been asked whether the two species of shellfish, which
appear physiologically distinct, would harbor similar vibrio burdens and/or potentially pathogenic
species. Hence, the comparison at different salinities in VA and MD waters and during storage
conditions. This question is independent of whether harvesting is allowed when elevated vibrio
levels occur in MD waters.

If the results of these and other studies dealing with uptake/elimination suggest that
differences between species are sufficient to cause concern, then exposure experiments could be
conducted under field conditions where harvesting would be legally permitted. To establish a
relation between consumption and health risk would involve either prospective or retrospective
epidemiological studies, studies which have never been conducted for a variety of reasons.

(ii)	long-term potential effects on native species and ecosystems

Proposal:

Long-term potential effects were not addressed in the proposal. Biosecurity measures
designed to minimize risks that will be followed in this project were described in Appendix III to
the research proposal.

Ad hoc panel comments:

Recommendation: Potential effects can be address by running the reproductive risk
model for this specific project and also in combination with previous experiments to examine
cumulative risk.

—Fritz: Pointed out that the long-term effects are largely unknown at this point. The pending EIS
is the next best answer to this question; but the Panel does not know those risks at this time.

(iii)	alternatives to the proposed action including the potential for using indigenous

or naturalized species

Proposal:

There are no alternatives within the context of the experimental design where Ca is
compared to Cv.

Ad hoc panel comments:

—King: Stated that she agrees with Kator's statement and concluded that there is a need for field
studies to clarify overall comparison between the two species.

—Tinsman: Suggested that the Panel report list laboratory experiments as an alternative to the
proposed in-situ experiments, and then use the justification stated in the proposal for what
laboratory experiments are not an acceptable alternate to field experiments.

(iv)	proposed culture or stocking method for introduction

Proposal:

All Ca oysters used in this research project will be provided by VIMS ABC.

—Kator. Stated he does not know anything about which stock is being used in the VIMS lab. He
is only aware of the Oregon strain and the triploid Ca. Kator would not have a problem with a
permit requiring this strain has to be used and must be separated from other strains in the lab.
The oysters should be from the F2 generation so that they are pathogen free.

The pathogens in the experiment are oyster and not human pathogens.

All Ca oyster stock will be coming from VIMS and not Horn Point.

Ad hoc panel comments:

—Fritz: Asked if the Oregon stock of Ca is the only source of test organisms for these proposed
experiments. He referred to page 25 of proposal. Some oysters were brought in from Asia
previously in 2005 experiments. Are these two stocks clearly separated at the VIMS lab?


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—King: Asked if there is a provision or protocol for testing for specific pathogens in oysters in the
lab prior to using oysters for in situ studies. Asked if there are plans for baseline testing of
oysters for pathogens.

—Klauda: Asked, where in the proposal is it stated that the oysters are isolated?
*Recommendation: Panel needs to know more about where the oysters are coming from and
what they are. They should be F2 generation or greater, free of oyster pathogens, of only the
Oregon strain, and produced at the VIMS hatchery.

—King: Clarified that some Ca were moved from VIMS to Horn Point in case something
happened to the VIMS stock—-so they would not lose their work. The Horn Point oysters are
serving as a redundancy stock of west coast C. ariakensis.

(v)	means of monitoring

Proposal:

Test containers are monitored on a weekly basis. The Pis will pull a sub-sample to see if
uptake is sufficient.

Ad hoc panel comments:

—Slacum: Repeated her earlier recommendation that every test oyster is accounted for from
the beginning to the end of the trial. This requirement should not be a burden to the Pis, since
the numbers of test oysters are small.

(vi)	review of information on known pathogens of proposed introduction and its
source

Proposal:

Oyster pathogens [Not sure what this means]

Ad hoc panel comments:

Need to get more information on which strain is being used and whether it is from the F2
generation.

(vii)	economic considerations

Proposal:

Economic information not discussed directly in this research proposal.

Ad hoc panel comments:

No real consideration since this is a research project and not an economic study.

~	Determination of Approval/Disapproval of the Proposal

Outcome: Specify issues to be addressed if proposal is approved or specify reasons for
not approving the proposal.

Several issues were mentioned above.

~	Panel Vote

The Panel voted on whether to approve, disapprove, or approve with modifications the
proposal, with these results:

MD- YES (Klauda voted for MD because Judy and Brohawn were absent) On 3/16/07 Chris
Judy (DNR) and Kathy Brohawn (MDE) wrote via email to confirm that MD does agree with
Ron Klauda's vote of YES.

PA- absent

VA- YES (VMRC has already issued a permit for the VA portion of the proposed project)
DC- absent

DE- YES, with requirement that the Pis apply the reproductive risk model and present the results

to the Panel
CBC- absent

Feds- YES, subject to recommendations discussed above.


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—Klauda: Asked if four of the seven voting members of the Panel are sufficient to reach a
decision.

—Fritz: Replied that traditionally if MD, VA, DE are present, that has been viewed as a sufficient
number of voting Panel members. Comments on the meeting notes and draft Panel report can
be submitted by missing voters within the timeline.

—Kator: Mentioned that the Pis would like to deploy test organisms this spring since they missed
last fall's deployment.

Action: King: Absent voters should comment on approval/disapproval while the draft report is
being dispersed.

Action: Genevieve and Ron will complete and distribute the draft Panel report to Panel
members by March 21.

Action: Genevieve will look up past research reports to find out where previous studies with Ca
were deployed. (Paynter, Luckenbach, Breitburg—maybe more.)

Action: Genevieve will distribute copy of the 1993 Policy, Ad hoc Panel procedures, and the
seven criteria for evaluating research with Ca to all Chespeake Bay oyster researchers.

Proposal B: Feasibility study on one-year grow-out of triploid C. ariakensis.

II. Proposal & Presentation of Data (James Kirkpatrick, VSC Project Manager)

James Kirkpatrick presented information on the VSC proposal.

Project duration: 1 year (beginning June 1, 2007)

Update on 2006 project:

-Average test Ca size at end of one year study is 85 mm and maximum size 106 mm. Over the
same study period, the average size for Cv is about 50mm.

Biosecurity Precautions:

-Kirkpatrick feels their current and proposed studies have acceptably low levels of risk relative to
projected numbers of diploid Ca ; they have looked only at single year risks at each study site, not
cumulative risks.

2007-2008 Project:

-Ca seed will be provided by VIMS/ABC. They're hoping to deploy Ca by June 1, 2007.

-VSC proposal assumes a certification of 1 diploid/1000 Ca test oysters. There is a significant

drop in risk if the Ca test oysters have a 1/10,000 diploid occurrence.

Klauda: Asked if the VIMS/ABS standard certification rate for diploid occurrence is now 1 in

10,000?

Stan Allen: Surmised that his facility can reduce the Ca diploid rates down from 1/1000 to
1/10,000; but they are having difficulty verifying this lower occurrence-have to count too many


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oysters. He believes that even if 1/10,000 is not regularly possible to achieve, they can
significantly reduce the diploid occurrence in triploid lots of Ca below 1/1000.

Why is VSC proposing a new feasibility study for 2007-2008:

—Kirkpatrick gave several reasons: 1) significant investments in gear, 2) local and regional
markets for triploid Ca have been established, 3) need to continue to improve methods to
achieve optimal profits, and 4) offer economic relief to growers if something was to happen to
their oysters.

—Kirkpatrick presented information on three proposed VSC sites where the reproductive risk
model showed that the working threshold of 2 diploid adults will be exceeded. To reduce the
cumulative risks to acceptable levels, a minimum inter-site difference should be established for at
least these three proposed sites that have issues with cumulative risk:

A- Chincoteague (Mason site) has had oysters at different sites in each of the three years of
feasibility studies.

-Distance between sites 1 and 2= 7.2 miles (11.5 km)

-Distance between sites 1 and 3=4.5 miles (7.2 km)

-Distance between sites 2 and 3=6.85 miles (11.0 kn)

B- Kinsale (Bevans)

-Distance between sites 1 and 2=0.75 miles (1.2 km)

-Distance between sites 2 and 3=1.4 miles (2.2 km)

-Distance between sites 1 and 3=2.15 miles (3.4 km)

C- Accomac (Hammer)—previous study site to proposed study site=1.6 miles (2.6 km)

—Kirkpatrick stated that one or more of the proposed 2007 study sites could be moved, if
needed, to reduce dispersal-related risk.

—Fritz: Asked if the model-predicted risk at these three sites exceeded the working threshold of 2
surviving F2 diploid adults.

—Kirkpatrick: Replied, yes.

—Slacum: Asked if these inter-site distances constitute a risk?

—Guy. Replied that the risk model used to establish the current working threshold of less than 2
diploid oysters from F2 generation assumed that each study site was geographically isolated from
other study sites. Originally, larval dispersal distances did not matter because the VSC study sites
were so far apart. However, the three VSC sites listed above that are proposed for the 2007 study
are not as far apart. What is the minimum inter-site distance required to consider a study site to
be geographically isolated?

—Mann: Commented that larval dispersal distance is a key question for this panel to discuss and
decide on. In May 2004, he wrote a critique on the current cumulative risk factor model that was
based almost completely on data he reported in a 1998 paper. He questions going out to 3
decimal places because the numbers that go into the model calculations are not that precise. He
pointed out that most of the cumulative risk numbers are lower than 1 diploid adult Ca, which is
problematic because you cannot have a fraction of an oyster. He also stressed that there are
large and unknown error bars around the risk model parameters and output. Therefore, the
working threshold of 2 diploid adults is not all that conservative. Given the uncertainty associated
with each histogram produced from the cumulative risk calculation, its possible that more than
just three of the proposed VSC sites would exceed the threshold value of 2 diploid adults.

Another fundamental question is what precaution should we take with the larval dispersal number
for each study site? If we need to separate sites to reduce the cumulative risks, how far must the
site be moved? He recommended that mortality overtime be considered in the cumulative risk
calculation. He suggested that the study footprint may be in the range of 1 to 10 km2. He came
up with a calculation of 20/km2 as a conservative risk aversive answer to questions associated
with isolation distances between study sites. But, he would be comfortable with an inter-site
distance of 1 km to achieve effect spatial isolation. He urged that the Ad hoc Panel give VSC a
requirement for inter-site distances to minimize the risk associated with Ca field trials.


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—Fritz: Concurs that the key question is how far apart between study sites is far enough.

—Mann: Pointed out that there are two important questions for the Panel to discuss and answer:
1) Is it appropriate for VSC to continue to conduct more field investigations with non-native
oysters?; and 2) What guidance should the Panel provide on the larval dispersal and minimum
inter-site distance issues to deal with cumulative risk?

—Fritz: Emphasized that there are other ways to mitigate the risk of in situ studies with Ca, such
as using triploid native oysters instead of Ca at those study sites that can not meet the minimum
inter-site spacing guidelines. He also mentioned that the higher powers at EPA Office of Water
agree that spacing out sites is an accepted mitigation method.

—Klauda: Returned to the question raised by Mann and asked whether this proposed VSC
project will supply new information that will be useful, especially since the 2006 VSC study results
are not yet available.

—Slacunr. Stated that the lead agencies have completed their economic data analyses to be
used in the non-native oyster EIS, and concluded that no new data, along the lines of what the
VSC proposed project would generate is needed for the EIS.

—Fritz: Stated that the federal agencies have been collaborating with Doug Lipton in terms of
economic exploration. They feel that economic and biological information is equally valuable.
VSC has a legitimate purpose of proving the June-June grow-out cycle. He pointed out that
important information has been gained from previous VSC field experiments, such as needing to
space the oysters out so that they can grow fast enough in one year to reach market size.

Federal policy is evolving as new information is being gained from these studies.
—Guy. Mentioned that the reproductive risk model, regardless of the size and uncertainty
associated with the error bars, is standardized across all sites and gives us a tool to compare
across and among sites and thereby an ability to manage risk. He feels that the numbers (i.e.,
height of the histogram bars) don't matter; what does matters is how the bars for the different
study sites compare to one another.

—Mann: Stated that the cumulative risk model does not factor in larval dispersal. The issue that
must be addressed is how far should you move sites (i.e., what is the minimum inter-site
distance) to remove risk?

—Guy: Emphasized that we need to tackle the issue of whether the Panel can support and
promote what Mann has written about the geographic isolation of sites so that larvae don't settle
in the same area. Mann showed dye studies in the vicinity of the Kinsale site, with dispersal rates
for five days. He concluded that you have a 50x comfort zone with this.

—Fritz: Recommended that if we stay with study sites that have exceeded the working threshold
of 2 from the risk model, or those sites that would exceed 2 if the 2007 studies are conducted,
those growers must have their sites at least 500m [did Mike mean to say 1 km?] away from sites
previously used. The dye studies need to be done for each site or else we could be moving
oysters to the critical red areas on the model.

—Guy: Stated that this year we need to address the three proposed VSC sites noted in their
presentation. He briefly discussed the risk assessment paradigm and concluded that the
methodology available to the Panel is consistent with risk assessment.

—Tinsman: Asked if an order of magnitude is something the Panel members are comfortable
with the risk model. He pointed out that the numbers in the risk model are not based on Ca. Each
variable in the model has the potential to vary more than one order of magnitude. He asked if we
are willing to accept any amount of risk for something that is a commercial trial. He offered an
opinion that there is nothing to be gained from this new VSC proposal. He strongly encourages
the panel to vote "No" on this proposal, because it is not scientifically necessary.

—Mann: Responded that as a single application tool, the risk model is useful. But, for assessing
cumulative risk of multiple field trials at the same site, the model's usefulness changes. Coming
up with numbers of 5-10km2, he suggested that the Panel accept a 1 km2 dispersal area. The
Panel should ask participants in the VSC proposed study to move their sites outside this area if
they are to be included.

—King: Asked if this recommendation is offered in light of a need for more EIS information or for
the industry?

—Mann: Responded by stating that he feels the proposed VSC study is needed.


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—Klauda: Repeated the question and asked where do the Panel members stand on whether we
need the 2007 VSC trial?

—Tinsmarr. Replied, NO; this project is for economic gain for individuals, there is nothing new
here.

—Kube: Asked the question, do we have enough information to deny the permit or issue the
permit with conditions?

—King: Replied that part of the justification for recommending that the VSC field studies proceed
in past years was for the information that would be gained. However, for this new proposal, this
justification does not apply because the EIS will come out this year and their economic analysis of
triploid Ca aquaculture is complete. There are projects that are currently funded that won't be
completed in time to be included in the EIS.

—Kube: Commented that this proposed VSC trial does not have the purpose of informing the
EIS.

—King: Stated that past approvals by the Ad hoc Panel were given based on the information that
would be gained from the field trials. She asked, should any risk be incurred for an industry trial
that does not benefit the public?

—Mann: Questioned the reality of the current timetable for release of the EIS. The information
from this proposal could be presented at the public comment period for the EIS. He emphasized
that we should not presume the outcome of the VSC project.

—Kube: Weather conditions could change this year and we could gain new information from the
2007-2008 field study. You can always gain from more information.

—King: Inquired why native triploids were not being compared with the Ca triploids in this
proposed field study.

—Erskine: Replied that triploid Cv has been grown since 2005, and this year they will plant 8-10
million triploid Cv. The reason for focusing most effort on Ca is because it's a guaranteed survivor
against oyster pathogens; but you cannot let them be exposed in the winter. The volume of
triploid Cv oysters produced by the proposed in this trial is still extremely small scale and would
only lead to about 4-5 days of shucking. Energy and monies have been put toward Cv in VA
aquaculture.

—Slacunr. Stated that we have much more empirical data for triploid Ca than with triploid Cv.
That is why we are concerned with another Ca project.

—Erskine: Asked where the triploid Cy seed would come from for VSC projects?

—King: Replied that triploid Cv oysters are there and they are growing them, but it is very
difficult to get information for Cv—unlike Ca for which there is abundant data. Wouldn't the
growers want a comparison between the two species to see which would be better for them?
Why is there not a side by side comparison between the two species in this VSC proposal?

There have been inconsistencies in how C.v. were handled in past VSC trials. They were not
treated in the same way as C.a. (separated out to allow greater growth, etc...)

—Fritz: Stated that the Panel has insisted from the beginning that the native oyster aquaculture
be tested equally with non-native oyster culture. They need good data to be used in the EIS.
—Alien: Mentioned that he does not feel that there is a lack of good data available on Cy and Ca
growth comparisons.

—King: Responded that the data are not valid because the Cv test organisms were not treated
the same as Ca in the experiments.

—Erskine: Stated that in 2003 and 2005, there were strictly controlled projects between the
species in different forms.

—Klauda: Emphasized that the original question to be addressed is whether this new VSC
proposal is needed.

—King: Replied that NOAA does not have a problem with Ca growth being investigated for the
EIS, and NOAA does not oppose this new VSC proposal. But, NOAA does not support a ramping
up of test organism numbers every year to build a non-native oyster industry pre-EIS.

—Fritz: Stated that EPA has similar comments as NOAA. EPA is weary of the ramping of Ca
numbers year by year by VSC, because it looks like a pre-judging of the EIS outcome. He would
like to see VSC scale down the numbers of Ca being tested in their field trials to numbers used in
previous years.


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—Kirkpatrick: Responded that they would like to have 13 growers involved and 1.3 million Ca
oysters.

—Gorski: Stated he agrees with Jamie King's comments. Corps has copies of letters previously
submitted by NOAA.

—Slacurrr. Stated that the FWS main issues were potential oyster larval movement between the
three proposed VSC sites, so there needs to be agreement among the Panel members on
whether Roger Mann's minimum inter-site distance numbers are acceptable.

*Recommendation: She is concerned that all the VSC sites be surveyed after oysters are
removed; especially wants the deeper sites surveyed for accidental loss.

—Mann: Replied that VA feels the information to be gained from the proposed VSC study will be
very useful. The proposal was circulated through VIMS for review/comment, without any
opposition.

—Klauda: Asked if the test organism counts are actual counts or estimates? (p.6 of proposal)
—Kirkpatriack: Replied that they do estimates of test organism numbers at the beginning of each
field trial, not actual counts.

—Fritz: Asked if VSC has records of accidents or spills by individual growers? We need to
understand the extent of human error.

—Kirkpatrick: Replied, Yes, they do have records, but no spill has occurred since he took over.
In August 2006, the Sopko dock broke.

—Slacum: Stated that she is concerned with human error when handling test oysters.

—Erskine: Replied that VSC makes it clear that any member of the Panel or permitting agency
can contact James Kirkpatrick or AJ Erskine to visit the study sites.

—Klauda: Asked if the VSC could add a clause in their agreement form stating that the growers
agree to have/implement an emergency plan.

—Slacum: Responded that these emergency and other provisions are included in state and
federal permits. Klauda was referring to the Industry Trial Agreement between the VSC and
growers presented on pg. 33 of the VSC proposal.

—Klauda: Asked the Panel if there is consensus that the proposed VSC trials have sufficient
merit to deserve approval.

—Guy: Responded that if the high risk sites are geographically separated, they become two
separate sites. He would argue that sites in Tom's Cove may not really be geographically
separated. He recommended that if we use a 1 km distance from the center point of the grower's
site and circle it, and then do that for the second site, they cannot overlap to be called
geographically-isolated.

—Mann: Suggest that the Panel ask VSC to provide an explanatory map of their previous,
current and proposed study sites. They should be asked to move their operations so that new
sites do not overlap any of the previous sites. Growers should not be not allowed to overlap the
site footprint if the cumulative risk model said that site would the working threshold of 2-a
measure of geographic isolation.

—Guy: Mentioned that the numbers in the risk model have always been actual numbers for
diploidy rate.

—Allen: Stated that he has always adhered to the 1/1000 diplloidy rule. The Panel should write
in provisions for these numbers.

—Klauda: Asked about the cumulative risk graph: Since there are no error bars
plotted around each histogram, should you round the number up? Since there are some bars
that approach the threshold line of 2, isn't that close enough to qualify for a 1 km inter-site
distance recommendation?

—Mann: Mentioned that the cumulative error is potentially enormous. You can not really use
decimal points of animals. If you do the calculations consistently, the graph is useful as a tool.
—Guy: Stated that you can assume that if you used the model you had 1 as a risk automatically
or you could use the real probability data. The graph shows that you will eventually establish a
population as you go on. Due to the nature of the tool, you cannot put error bars on the
histogram.

—Fritz: Commented that this tool gives us what we can call an index with a threshold value of 2.
This number gives you a sense of accumulating risk and has some biological use.


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—Klauda: Asked if the three sites on this histogram with risk values above 2 will meet the
minimum inter-site distance requirement (I km?)—-or substitute with diploid Cv (Fritz).

~	Panel Discussion/Q & A

Ron Klauda, Chair, led a discussion period that gave all Panel members a chance to

voice questions or concerns to the VSC attendees on their proposed field study.

~	Review of Seven Criteria and Responses

(i)	purpose and usage of proposed introduction

Proposal:

1) To re-test the feasibility for a one year market product fortriploid C. ariakensis. 2) To
continue to establish a market for C. ariakensis and further perfect grow out methods.

Ad hoc panel comments:

A range of concerns were expressed regarding the justification for and need of the results
that this new feasibility study would likely produce.

(ii)	long-term potential effects on native species and ecosystems

Proposal:

These issues were not directly addressed in the proposal. Potential effects will be
reduced by using triploid Ca and deploying one-year old test oysters for only one year.

Ad hoc panel comments:

There was general agreement among the Panel members that a threshold of 2 from the
reproductive risk model and a minimum inter-site distance of 1 km should be required if the VSC
proposal is approved. However, there is much uncertainty about how these effectively measures
will reduce long-term potential impacts.

(iii)	alternatives to the proposed action including the potential for using indigenous

or naturalized species

Proposal:

Triploid C. ariakensis aquaculture has proven profitable and marketable for the Virginia
oyster industry. This proposal represents an effective and reliable option. Native oysters have not
proven as profitable due to disease pressure and slower growth rates.

Ad hoc panel comments:

Panel members recognized that the focus of this proposed field study is to collect more
information on grow-out and marketability of the non-native C. ariakensis.

However, if the VSC proposal is approved, several Panel members urged the VSC to find ways to
also include triploid C. virginica in this field study.

(iv)	proposed culture or stocking method for introduction

Proposal:

Triploid Ca seed, certified to have no more than 1 diploid/1000, will be obtained from the
VIMS facility.

Ad hoc panel comments:

If the VCS proposal is approved, the Panel would like to know the diploid occurrence rate
in each batch of triploid Ca seed distributed to the various growers involved in the 2007 field
study. In addition, the Panel will recommend that appropriate test organism densities and a
minimum inter-site distance of 1 km be achieved by all growers involved in the study.

(v)	means of monitoring

Proposal:

A project manager (PM) will be selected to work with the seafood industry and will be
involved with the overall monitoring and data collection efforts for the industry. They will be
responsible for collecting data regularly, insuring consistency among sites, record keeping, and
risk management regulations and emergency plans adherence. The PM will collect inventory
(mortality reports, quarterly estimates of stocks, product removal and monthly grow-out
measurements), monitoring and economic data from each participant.


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Ad hoc panel comments:

If the VSC proposal is approved, the Panel will recommend that a complete accounting of all test
organisms (triploid Ca and triploid Cy) be achieved and the results reported to the Panel.

(vi)	review of information on known pathogens of proposed introduction and its
source

Proposal:

This issue was not specifically addressed in the proposal. 10mm triploid Ca seed from
the VIMS facility will be the source of test organisms.

Ad hoc panel comments:

In this proposal is approved, the Panel will recommend that only triploid Ca seed from the
VIMS facility be used by all growers involved in the field studies.

(vii)	economic considerations

Proposal:

The 2003-2005 VSC field studies demonstrated the economic feasibility of triploid Ca
aquaculture. This proposal will re-test the culture methods developed in previous studies and
evaluate the one-year growth of triploid Ca across a range of salinities.

Ad hoc panel comments:

There was a range of opinions among the Panel members about the potential value of
any economic information that the proposed VSC study might generate to the developing EIS.

~	Determination of Approval/Disapproval of the Proposal

Specify issues to be addressed if proposal is approved or specify reasons for not
approving the proposal were discussed above and below.

~	Panel Vote

The Ad hoc Panel members voted on whether to approve, disapprove, or approve the
VSC proposal with modifications. The voting results are:

Feds: YES, with provisions and modifications that will be fully described in the Panel report.
DE: NO, and will send minority report for inclusion in the Panel report.

VA: YES

MD: Did not vote at the 3/12/07 meeting. On 3/16/07 Chris Judy (DNR) and Kathy Brohawn
(MDE) wrote via email to confirm that MD votes YES with provisions and modifications that
will be fully described in the Panel report.

Recommendation: Permit conditions for monitoring and data delivery for last year (2006) should
be put in this proposal as well.

—Slacum: Asked if Roger Mann would talk to Elizabeth North (UMD/HPEL) regarding the 1 km
minimum inter-site distance he proposed.

Action: Genevieve will send Roger Mann a complete email list of all Ad hoc Panel members and
others.

Action: Roger Mann will send his 1998 paper, other relevant articles, and a summary of his
arguments on the risk model and 1 km inter-site distance to all Ad hoc Panel members.

Action: VSC will provide summation maps of their past, present, and future sites for field studies
with triploid C. ariakensis.

—Fritz: Asked that the Panel report make it clear that a majority approval of the VSC proposal is
not intended to be precedent decision. He then asked if the provisions and modifications (e.g.,
maintaining a minimum distance of 1 km between test sites) that the Panel will make will be
reasonable for the growers?

—Erskine: Replied that the growers involved in the VSC field study should be able to make those
requested changes.


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Recommendation: The majority of Panel members approved the VSC proposal with several
caveats, including a minimum distances of 1 km between at least three of the proposed study
sites.


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