FINAL

Meeting Summary/Minutes

The Good Neighbor Environmental Board Meeting

Sul Ross State University

Alpine, Texas

October 24-26, 2006

Meeting Theme: Big Bend / El Gran Recodo

Administration: U. S. Environmental Protection Agency

Office of Cooperative Environmental Management

		Table of Contents

	Participants	.2

	Welcome and Introduction	.4

	Opening Remarks	.4

	Keynote Speaker Presentations:

		National Commission on Protected Areas	.5

		The National Park Service and Protected Parks	.6

	Speaker Presentations:

		Wild and Scenic Rivers Program	.8

		 Regional Water Planning and Water Availability	 9

	Public Comment Session	11

	Speaker Presentations:

		Regional Haze in Texas Big Bend Area	12

		Changing Physical Template of our Shared Rivers	14

		Controlling Invasive Plants along the Rio Grande	15

	Business Meeting	17

		Welcome	17

		Approval of the Minutes from Last Meeting	17

		Public Comment on the GNEB Tenth Report	17

		Selection of Locations and Dates for 2007 Board Meetings	18

		Membership Status	19

		Board Member Report-Outs	20

		Selection of Theme and Topics for the Eleventh Report	22

		Standard Operating Procedures for GNEB and CEQ	25

		Business Meeting Ends	26

The Good Neighbor Environmental Board

Sul Ross State University,

Alpine, Texas

October 24-26, 2006

Meeting Summary/Minutes

DRAFT

Meeting Theme: Big Bend / El Gran Recodo

Day 1 – Tuesday, October 24, 2006						(9:37 a.m.)

Meeting Participants:

Non-Federal Board Members

Paul Ganster, Ph.D., Chair and Director, Institute for Regional Studies
of the 	Californias, San Diego State University, San Diego, California

Christopher P. Brown, Ph.D., Associate Professor, New Mexico State
University, 	Las Cruces, New Mexico

Michael P. Dorsey, Chief, Hazardous Materials Division, San Diego County
	Department of Environmental Health, San Diego, California

Edward Elbrock, Rancher, Malpai Borderlands Group, Animas, New Mexico

Jennifer A. Montoya, U.S. Program Director, Chihuahuan Desert
Conservation 	Project, World Wildlife Fund, Las Cruces, New Mexico

Stephen M. Niemeyer, Texas Commission on Environmental Quality (TCEQ),
Austin, Texas

David Randolph, Border Coordination Officer, Arizona-Mexico Commission,
Phoenix, Arizona

Douglas S. Smith, Director, Corporate Environmental Safety and Health,
Sony 	Electronics, Inc., San Diego, California

Robert Varady, Ph.D., Deputy Director, Udall Center for Studies in
Public Policy, 	University of Arizona, and Research  Professor of
Environmental Policy, Tucson, 	Arizona

Ann Marie A. Wolf, President, Sonora Environmental Research Institute
(SERI), 	Tucson, Arizona

Federal Board Members

Carl Edlund, Director Multimedia Planning and Permitting Division,  EPA
Region 6

Gary Robison, Assistant Chief, Asset Management Division, Customs and
Border 	Protection, U.S. Department of Homeland Security, Washington,
D.C.

James Stefanov, U.S. Geological Service, U.S. Department of Interior,
Austin, Texas

Board Resource Specialists

Lana Corrales, National Center for Environmental Health, Center for
Disease 	Control and Prevention, Atlanta, Georgia (HHS Alternate)

Sally Spener, Acting Secretary, U.S. Section, International Boundary and
Water 	Commission (IBWC Alternate), El Paso, Texas

Carlos Rincon, Ph.D., Director, U.S. EPA Region 6 Border Office, El
Paso, Texas

EPA/OCEM Staff and Management

Rafael DeLeon, Director, Office of Cooperative Environmental Management,
EPA

Elaine M. Koerner, GNEB Designated Federal Officer (DFO)

Geraldine Brown

Speakers:

Vic Morgan, President, Sul Ross State University, Alpine, Texas

Mickey Clouse, Mayor, Alpine, Texas

Judge Val Clark Beard, Brewster County, Texas

Dr. Ernesto Enkerlin, President, National Commission on Protected Areas,
Mexico

Russ Whitlock, State Coordinator, Texas National Parks, National Park
Service

Paul Silber, private landowner, Wild & Scenic Rivers Program

Tom Beard, Far West Texas Water Planning Region

David Schanbacher, Texas Commission on Environmental Quality

Jack Schmidt, Professor, Utah State University

Mark Briggs, World Wildlife Fund

Public Commenters:

Aimee Roberson, U.S. Fish and Wildlife Service

Juan Antonio Flores, Public Affairs Director, North American Development
Bank

Leslie Hopper, Rio Grande Research Center,  Sul Ross State University
(Sul Ross)

Kevin Urbanczyk, Chair, Department of Earth and Physical Science, Sul
Ross, and 	Project Director, Rio Grande basin grant, USDA

Public Attendees:

Larry Allen, former GNEB member, Albuquerque, New Mexico

Adelina Beall, Graduate student, Geology Department, Sul Ross

Tom Beard, rancher, Alpine, Texas

Jeff Bennett, Physical Scientist, Big Bend National Park

Vidal Davila, Big Bend National Park, organizer of the GNEB field trip

Margaret Earnest, Texas Commission on Environmental Quality (TCEQ)

Chad Ellis, Natural Resources Conservation Service, Alpine, Texas

Ty Fain, Rio Grande Institute, former drafter of GNEB legislation

Keith Klein, Professor, Industry and Technology Department, Sul Ross

Matthew O’Toole, Research Technician, Rio Grande Research Center, Sul
Ross.

Brad Traver, Acting Superintendent, Big Bend National Park

Tom Shiller, student, Sul Ross

Keith Sternes, Chair, Department of Biology, Sul Ross

Background

The Good Neighbor Environmental Board (GNEB or the Board) is an
independent advisory committee that is managed by the U.S. Environmental
Protection Agency (EPA).  It advises the U.S. President and Congress on
good-neighbor practices along the U.S.-Mexico border.  The focus is on
the environmental and infrastructure needs of the U.S. states that
border with Mexico.

Welcome and Introductions

Rafael DeLeon, Director, Office of Cooperative Environmental Management
(OCEM), EPA, welcomed board members and guests to the October 2006
meeting of the Good Neighbor Environmental Board (GNEB) meeting in
Alpine, Texas. He thanked President Vic Morgan and his staff of Sul Ross
State University for hosting the meeting. He acknowledged Mayor Mickey
Clouse and Judge Val Clark Beard and thanked the National Park Service
and members of the Planning Committee for their efforts. Director DeLeon
noted that this was the first GNEB meeting in this part of the border
region and he looked forward to hearing about the area’s environmental
issues. He then introduced GNEB Chair Paul Ganster, Ph.D., who would
chair the meeting.

Dr. Ganster, Chair, described the GNEB as a Federal advisory panel that
advises the President and Congress about environmental conditions along
the U.S./Mexico border. GNEB meets three times each year, two times in
border communities and once in Washington, DC. He said that it was
important for Board members to interact with people in border
communities, to listen to their concerns and issues, and to understand
their different cultures. He invited audience to pick up a copy of the
Board’s earlier annual reports that were available at the meeting.

Elaine Koerner, Designated Federal Office, (DFO), welcomed members and
other participants and introduced the three distinguished local
officials, Vic Morgan, President Sul Ross University, Mayor Mickey
Clouse, and Judge Val Clark Beard, who would make opening remarks.

Opening Remarks

Vic Morgan, President, Sul Ross State University, welcomed members to
Alpine, Texas and the University and described the background of
Lawrence Sullivan Ross, for whom the University was named. He summarized
three projects in the Sustainable Agricultural Water Resources in the
Rio Grande River Basin research project and identified key researchers
at the University, as follows:

1.Upland Range Management in the Upper Terlingua Creek Basin, a large
watershed that flows into the Rio Grande, involving removal of invasive
plant species to improve water resources. (Bonnie Warnock)

2.Water quality issues and pathogen sampling in the Rio Grande (Keith
Sternes)

3.Regional ground water studies that quantify underground aquifers’
resources

(Dr. Kevin Urbanczyk and Leslie Hopper).

President Morgan announced $2 million in funding from the Department of
Defense (DOD) for the analysis of a deployable, aqueous, aerobic
bio-reactor (DAAB) for treatment of waste water, which can then be
returned to the environment. Sul Ross and other universities in the
Texas State University System would be involved in testing the water
quality.  The project has applications for the military and for water
disaster areas along the border and the Colonias. President Morgan
stated that the University supports the goals and mission of the GNEB
and offered the University as a resource for environmental work along
the border.

Mayor Mickey Clouse welcomed members to Alpine and the Big Bend area of
Texas and thanked the Board for listening to the area’s concerns.
Major concerns are health care in rural hospitals, emergency
preparedness, border security, Mexican trucks and NAFTA truck
provisions, wildlife and vegetation protection, and homeland security.

County Judge Val Clark Beard of Brewster County strongly stressed the
benefits of clean air and water and protection of the environment in the
Big Bend area that were agreed upon by all residents despite their
diversity. The major concerns are water, clean air, light pollution,
open space preservation, sustainable agriculture, tourism, outdoor
recreation, and air pollution from truck traffic in downtown Alpine due
to La Entrada al Pacifico from Chihuahua, Mexico.  All of these concerns
either depend on or affect a healthy environment. Judge Beard invited
the GNEB to become part of the constituency that includes local
residents and visitors who want to protect the environment in the Big
Bend area.

Chair Ganster thanked the local officials and presented each of them
with a certificate and a GNEB pin. DFO Koerner then asked everyone to
introduce themselves. After the introductions, Chair Gangster introduced
the first keynote speaker, Dr. Ernesto Enkerlin, President, National
Commission on Protected Areas of Mexico.

Speaker Presentations

First Keynote Speaker

Dr. Ernesto Enkerlin, President, National Commission on Protected Areas,
(CONAP) Mexico, described the National Commission for Protected Areas,
its accomplishments, protected areas, international standing, and
mission to protect, manage and restore the environment in Mexico. CONAP
is the only federal-protected area agency in Mexico; its
responsibilities cover 50 million acres in 158 protected areas that
include marine parks, biosphere reserve, wildlife refuges, and
sanctuaries. A major difference between CONAP and other national
agencies is their coverage of 2,000 rural, indigenous, and high poverty
communities for whom CONAP represents the government. The protected
areas provide opportunities to improve human welfare, mitigate the
effect of hydrological, meteorological or natural disasters, and protect
the genetic resources of the county.

Slogans for the three basic concepts of protection, management, and
restoration are:  to preserve and prevent with protection, to use and
maintain through management; and to recover and restitute through
restoration. [PROFEPA] provides the law enforcement capabilities, which
started with Inspecsion Vigilancia covering 12 percent of the protected
areas, and has grown to cover 85 percent. A major effort with PROFEPA is
the establishment of community-run protection committees which work on
conservation and protection against illegal activities.

Dr. Enkerlin outlined many of the projects that are covered in the
six-year report as follows:

Improving the supply of fresh water to the fisheries and wetlands of the
upper Gulf of California

Developing eco-tourism that respects nature and benefits both the state
and localities.

Initiating a program of sustainable rural development in 2,000
communities

Restoring the environment along the Rio Grande

Maintaining the natural environment, such as the mangroves, which
protected the Sian Ka-an Biosphere Reserve in Quintana Roo from damage
due to Hurricane Wilma

Practicing indirect conservation through knowledge, investigation,
recovery of traditional knowledge, and preservation of culture through
programs such as National Conservation Week, education of school
teachers and children, and Cine Minutos in local theaters.

Preserving priority species such as marine turtles by releasing 150
million turtles into the world seas

Certifying private landowners who practice conservation on their
property and offering financial incentives.

Dr. Enkerlin reviewed the progress in the percentage of land that has
been restored over the five years, starting with 5.7 percent and
increasing to 60 percent. The percentage of agency-covered land with
management plans in place increased from 42 percent to 70 percent.
Protected areas has grown from 1.3 million hectares in 50 protected
areas to 17 million in 127 protected areas. The growth has been
sustained by collecting fees for access to protected areas. Mexico has
also achieved recognition for the fourth largest number of species, the
second largest number of ecosystems, and second in the number of
RAMSTAR-designated sites. The number of biosphere preserves has also
increased and Mexico is second only to the United States in the
incorporation of new sites. The long term plan is to increase the number
of World Heritage sites to 15.

CONAP’s mission is to gain recognition for their priority sites on an
international scale as a model for conservation. In order to achieve
this end, it is necessary to work with rural communities, private
landowners, and states and local communities in the co-management of the
environment. In Mexico, the agency has multi-partisan support and is
working with the transition team of President-elect Calderon on his
priority to support the protected areas by increasing personnel by 15
percent, making better use of protected areas, promoting eco-tourism,
and increasing management resources.  Dr. Enkerlin closed by stating
that the U.S. and Mexico should work together on their shared border
environment to achieve sustainability.

In response to a question from Rosario Treviño about a 1942 Agrupación
Sierra Madre resolution to establish a bi-national Big Bend Park, Dr.
Enkerlin said that there are two new protected areas along the Mexican
side of the Park: the Rio Bravo del Norte and the El Campo. The land is
privately owned, so financial incentives may be needed.

Second Keynote Speaker

 Russ Whitlock, State Coordinator, Texas National Parks, National Park
Service (NPS), reviewed the recent change in leadership by announcing
that Mary Bomar is the new Director of NPS replacing Fran Mainella, who
recently resigned. Mr. Whitlock was the Chief of Staff at NPS for two
years and the superintendent of the Lyndon B. Johnson National
Historical Site. The NPS has been working with protected areas and
partners with Mexico for over 70 years. The NPS agreement with
Mexico’s National Commission on Natural Protected Areas produced the
Sister Parks program, including Big Bend, Maderas Del Carmen, and Cañon
de Santa Elena. Mr. Whitlock reviewed other joint projects on such
projects as invasive species, firefighting, joint training, biological
inventorying, collecting data on wildlife and plant species, and air and
water quality monitoring.

In the future, these protected areas hope to identify wildlife movement
corridors between Organ Pipe, El Pinacate, and Cabeza Prieta national
wildlife refuge, and work jointly on other environmental projects. NPS
would like the GNEB to recommend that official representatives on both
sides of the Rio Grande be allowed to resume informal border crossings
in Big Bend National Park. The restrictions on border crossings since
9-11 have made cooperation difficult.

Some recent progress includes a sister park project between White Sands
National Monument and Guadalupe Mountains National Parks, and
collaboration between NPS and Mexico’s National Institute of
Anthropology and History on educational and cultural projects. The two
agencies have exchanged technical information, cooperated on research,
promoted historical trails, promoted Spanish mission sites, and worked
with local communities to establish an historical cultural tourism route
between the two countries. This cooperation has benefited the Service by
improving management of cultural heritage areas.

In closing, Mr. Whitlock said the NPS is committed to continue
collaboration and communication on resource conservation. A recent
Department of Interior session in Waco, Texas, focused on the same
themes mentioned by Judge Beard; now there is a standing order for
superintendents to work on engagement of civic organizations
communities, and private landowners on the environment.  Mr. Whitlock
opened the session for members to ask questions to the Acting
Superintendent of Big Bend National Park, Brad Traver, and his
environmental leadership staff.

Questions and Comments

Responders: Brad Traver, Acting Superintendent, Vidal Davila, Jeff
Bennett, Physical Scientist, Big Bend National Park

Chair Ganster and Stephen Niemeyer asked about the effects of increased
border security on joint management, species migration, and local
ranchers.  Mr. Traver answered that a larger issue was the inability of
visitors and families to cross over to the other side of the park.
Management of the river cannot be done on one side only. Vidal Davila
added that another problem was Mexican farmers’ livestock that was let
loose and is damaging the river and the park on the U.S. side.

David Randolph asked whether the Heath Canyon La Linda Bridge was still
part of an ecosystem plan or was going to be demolished. Mr. Davila
thought that the Coast Guard had decided not to demolish the bridge
because of a tourism initiative. Dr. Enkerlin suggested the need for a
special border zoning for international cooperation similar to the
agreements on jaguars with Belize and Guatemala that allow border
crossing of Mexican Park staff.

Jennifer Montoya asked about the tamarisk removal program along the
river and the relationship between the NPS and the Rio Grande Institute.
 Mr. Davila said that NPS was able to fund the Rio Grande Institute to
hire Mexican workers through the IBWC who issued the workers special
work permits to work along the river to remove the tamarisk. The WWF
also provided funding. Mr. Bennett added that Mexico has been
eradicating the tamarisk for several years. In response to a question
from Ms. Montoya about the release of beetles to control salt cedar, Mr.
Davila responded that Big Bend National Park is going to be writing an
environmental assessment to release the beetles within the Park. The
U.S. Bureau of Reclamation is funding the study in the Forgotten River
section and the beetles will be released this year.

Christopher Brown asked if it was possible to include Dr. Enkerlin’s
recommendation about an agreement on informal border crossings for
researchers and Park staff in the current Report or at the GNEB Business
Meeting.  Chair Ganster thought that this suggestion would be discussed
the following day. Mr. Niemeyer said he was encouraged by all the
positive steps toward binational cooperation on cross-border efforts.

Dr. Enkerlin added three items to his presentation: a protected area in
Janos for Blackdale Prairie dogs, clean-up of the San Pedro River, and a
Monarch Butterfly flyway that includes  stepping stones and sanctuaries
between Canada and Mexico. In response to a question from DFO Koerner,
Dr. Enkerlin said he was the Chair of the Conservation Working Group of
the North American Commission on Environmental Cooperation (CEC) that
would be meeting in Cancun.

Jennifer Montoya asked if the Zonas Forestales were under CONAP. Dr.
Enkerlin said that some forest preserves have been incorporated as flora
and fauna protected areas or natural resources protected areas. The
“forest preserve” category does not exist under Mexican law, but
some of the forest reserves are being registered and protected under new
categories. He answered Ms. Montoya’s query about “Mawawi” by
stating that the project was problematic has been reconceptualized, and
is now the San Pedro initiative.

Wild and Scenic Rivers Program

Paul Silber, Rio Grande private landowner, provided members background
on the development of the Wild and Scenic Rivers management plan.
Several ranchers, including himself, purchased Bullis Gap Ranch, in
Brewster County, along the Rio Grande, in order to preserve it from
development and public recreational usage. Beginning in 1970’s, the
Texas Legislature, the U. S. Congress, and the National Park Service
wanted to designate, first the Guadalupe River, and then the Rio Grande
as Wild and Scenic Rivers to prevent the land from being developed into
condominiums.  The landowners opposed these designations because of the
principle of private property rights defined as “It’s my land, not
yours.” The major landowner concern was the government’s right of
eminent domain, which could effectively deprive them of their property.
The landowners maintained that they wanted to preserve the land as wild
and scenic, but not lose their property rights.

After 25 years of legislative proposals and political wrangling between
the National Park Service and the landowners, who successfully defeated
the Park Service’s management plans and legislation for certain
sections of the Rio Grande as a wild and scenic river, the NPS created
the Rio Grande Partnership Team to develop a management plan with
participation from landowners.

In 2000, at a two-day meeting in Sanderson, Terrell County, the
landowners met with the NPS, under the leadership of Attila Ballity, NPS
project manager.  The subsequent discussion revealed that the two sides
were in agreement on the need to preserve the river, but only if the NPS
would give up the right to eminent domain, which it was willing to do.
The factors that allowed an agreeable management plan and contracts to
be developed included:

The landowners realized that they needed NPS to help protect their land.

Without eminent domain, NPS could not subject land owners to unwanted
regulation.

The river could only remain wild and scenic if traffic was limited by
NPS to historic numbers.

The NPS rules and regulations would apply to the public, but not to the
landowners on their own lands.

With a contract, the NPS could not change the rules to implement a
different plan.

Mr. Silber summarized the provisions of the contracts with landowners,
which essentially allowed NPS to have access to private lands in
perpetuity for the purpose of enforcing NPS rules for public access.
Next, the management plan needs to be agreed to by Mexico, upstream
canyons need to be included, and the U.S. and Mexico need to establish a
river corridor in which each party will implement its own laws and
regulations. Mr. Silver added that illegal immigration and drug traffic
threaten public safety along the river. Mr. Silver praised the NPS
leadership under Park Superintendent Frank Deckert for using a
consensus-building approach to land management.

Chair Ganster asked Ernesto Enkerlin what Mexico could do to protect the
river.  Dr. Enkerlin responded that a decree to designate 500+ miles of
the Rio Grande as a natural monument is being finalized. The decree will
be done under the Law of Ecological Equilibrium and Environmental
Protection in Mexico regarding protected areas and natural monuments
(LGEEPA, Spanish acronym).

Michael Dorsey asked Mr. Silver to expand upon the drug trafficking
problem on private property and how they would be held responsible by
the Drug Enforcement Agency (DEA).  Mr. Silver described how illegal
persons would cross the border with 50-pound packs of drugs and then ask
ranch foremen to transport them back to the border, which could
implicate ranchers in drug trafficking.  At present, landowners are
armed when they patrol their ranches to protect themselves.  The land is
too remote to get effective help from the Border Patrol.

Ms. Montoya praised the NPS for using a unique, flexible approach
tailored to social and environmental conditions. Mr. Niemeyer questioned
why the population could not be controlled by the NPS.   Mr. Silver
responded that due to the growth in population and the popularity of the
parks the demand on resources may be too great.  Mr. Edlund promised
that he would take this example of cooperation back to the EPA. Mr.
Silver responded that EPA might not like part of the agreement that
prohibits NPS from conducting surveys or studies without the
landowner’s consent. He expressed some resentment over the Endangered
Species Act—specifically about the Golden Creek Warbler and rules
about clearing salt cedar. Mr. Silver said that the NPS effort to find a
regulation that supported the landowners view was a perfect example of a
can-do rather than a can’t-do approach.

Mr. Silber responded by recognizing Jennifer Atchley (now Montoya) for
her help.

Regional Water Planning and Water Availability

Tom Beard, Chair, Far West Texas Water Planning Region, opened the topic
of water planning by describing an effort, called Rio Nuevo, to take
groundwater from Far West Texas and transport it downriver via the Rio
Grande to potential buyers, including farmers, cities, or even Mexico.
This method would destroy the desert areas and would lose 80 percent of
the water due to evaporation.  Under the present Texas laws, including
the Rule of Capture, owners downstream and water districts could not
stop this drainage of water resources.  Recently, the Texas General Land
Office released a request for proposals to produce, transport, and
market waters from state lands, primarily from Far West, Texas.

Regional water planning has developed out of a realization that state
water planning was inadequate. In 1997, legislation was proposed by then
Lieutenant Governor Bob Bullock to address severe drought problems. The
16 regional planning groups’ members represent economic and political
interests who are knowledgeable about the area. Each regional group
develops a 50-year plan that is revised every five years and is based on
future water demand, water supply, and water allocations. Increasingly,
the regional water plans have been subject to state demands for
information and allocation formulas determined by the state demographer
and the Texas Water Development Board.  The main problem is that
regional plans have no enforcement provisions.

Another major problem is that although the State of Texas has the right
to regulate, allocate, and control surface water, most of the water is
already allocated. Some controversy exists over whether water is ground
or surface water.  Based on the Rule of Capture, a landowner could
legally drill a well that drains all of the groundwater from under his
neighbor’s land. The Rio Nuevo plan, based on land owned by Texas,
could legally drained the water from adjoining ranchers land.
Groundwater districts can set some requirements, but most do not have
the data to back up their requirements.  Mr. Beard feels that regional
water planning is the best way to manage water despite the Rule of
Capture which was adopted by a court ruling of the Texas Supreme Court
in 1906 and is based on English Common Law.

Mr. Beard said his regional water planning group has submitted a request
to the Water Development Board for about $500,000 to begin testing some
wells to determine water draw-down, recharge, recovery rates, and the
effect on nearby wells.

Water availability estimates include supply, demand, locations,
allocations, and strategies to meet the need, but most of these
estimates were done by localities in a vacuum.  Regional water planning
groups can advise and suggest ideas and bring new tools such as water
availability models for rivers and ground water which, when perfected,
could help groundwater districts and localities do rational planning.

Mr. Stefanov asked if regional water planning was addressing in-stream
flow issues.  Mr. Beard thought that both the Texas legislature and the
regional groups would need to address in-stream flows and environmental
use in the next few years.  Carlos Rincon asked if water quality was
included in the planning.  Mr. Beard acknowledged that every water
management strategy has to include a water quality and cost analysis.
This was an issue in El Paso’s plan to use desalinization to increase
the water supply.

Christopher Brown suggested using an environmental water district to
lease in-stream water rights from agricultural rights holders. Mr. Beard
agreed that a mechanism needed to be in place to regulate in-stream
effects.  If a city, like El Paso uses river water and puts treated
water back into the river, the in-stream effects need to be evaluated.
Monetary allocations need to be provided to purchase water rights to
maintain the in-stream flow.

Afternoon Session								(2:06 p.m.)

Public Comment Session

DFO Koerner opened the afternoon session by stating that the meeting was
now open for public comments on GNEB issues and on the Tenth Report to
the President and Congress as published in the Federal Register. Four
people had signed up to make public comments.

Aimee Roberson, U.S. Fish and Wildlife Service (FWS) discussed the Rio
Grande Silvery Minnow, an endangered species that FWS is trying to
re-establish in the Big Bend reach of the Rio Grande. The recovery plan
identified three goals: to stabilize the Minnow populations in New
Mexico, to protect the habitat within its range, and to re-establish the
Minnow in its other historic areas. The proposal is under section10 (j)
of the Endangered Species Act (ESA) that allows establishment of
experimental populations. The section can reduce the ESA-related
requirements and ensure that there will be no adverse impacts.

One of the items to improve the habitat is the removal of exotic
species, such as salt cedar, which will also help to restore the
river’s ecosystem. A preliminary draft of an environmental assessment,
an implementation and monitoring plan, and a proposed rule are under
review in the FWS regional office and will be available to public
comment in 2007. Some of the partners in this effort include, IBWC, Big
Bend National Park, National Park Service, USGS, Bureau of Reclamation,
Texas Commission on Environmental Quality, Texas Department of
Agriculture, Texas Parks and Wildlife Department, Texas Water
Development Board, the Texas Farm Bureau, the University of Texas, the
World Wildlife Funds, the Far West Texas Regional Planning Group, and
the Rio Grande Institute.

Juan Antonio Flores, North American Development Bank (NADBank),
explained that NADBank and its sister organization, the Border
Environment Cooperation Commission (BECC), were U.S./Mexico binational
institutions created to finance and develop environmental infrastructure
along the U.S./Mexico border.  Mr. Flores thanked the GNEB and other
groups interested in the border community for supported BECC and NADBank
in their endeavors through letters and comments to public officials in
the U.S. and Mexico. The Bank is involved in 95 infrastructure projects
with approved financing of about $2.5 billion dollars. More than half of
the funds come from the Border Infrastructure Fund provided by EPA and
appropriated by Congress on an annual basis.

Currently, there are $240 million in loans approved and another $137
million for 22 projects will be presented to the Board of Directors for
their approval. The largest loan is $28 million to the City of
Monterrey, Nuevo Leon for a citywide, industrial water reuse program.
The rate of disbursing money has improved as 84 percent of approved
monies have been contracted and 63 percent have been disbursed on a
reimbursement basis for completed construction. For example, over 11
million people will benefit from 40 wastewater treatment plants, 17 of
which are in communities which had no wastewater treatment services.

To reduce air pollution, nine street paving projects of over 9 million
square meters is being financed in Mexican cities such as Rosarito,
Tecate, and Ciudad Juarez. Technical assistance for improving governance
in local communities is being provided through 207 studies. Training of
utility employees to conduct surveys, funding management information
systems, and doing rate studies would increase professional capacity in
the future. Long-term sustainability of these utilities by recouping
costs of services is the ultimate goal, but grant money will be a
necessary catalyst. The Border Environment Infrastructure Fund has
diminished from $100 million annually to $30 million for FY 2008.

Questions and Comments

Carl Edlund told members that at a meeting with President Bush, EPA’s
Deputy Administrator, Marcus Peacock, was able to state that one of the
environmental successes was the hookup of clean water or sewage service
for 50,000 people along the border due to the work of NADBank and BECC.

Leslie Hopper, Rio Grande Research Center, Sul Ross State University,
described the Sustainable Agricultural Water Conservation in the Rio
Grande Basin Project as a federally-funded research project under the
USDA at the University and throughout the Texas State University System.
The projects include modeling of groundwater resources, surface quality
investigations, resource utilization investigations, and water
reclamation.  Education and outreach includes curriculum development for
K-12 that teaches stream-side science and water quality.

Kevin Urbanczyk, Chair, Department of Earth and Physical Science, Sul
Ross, spoke as the Project Director on a USDA Rio Grande grant, that is
related to sister projects out of the Texas Water Resources Institute,
Texas A & M, New Mexico State University, and the New Mexico Water
Resources Institute.  The Texas State University System is focused on
obtaining funds from the United Nations Global Environment Fund (GEF)
for research on the Rio Grande. Another project is the Deployable
Aqueous Aerobic Bio-reactor (DAAB) to test the functionality of portable
wastewater treatment plants funded by the DOD.

Christopher Brown commented that recommendations from the Rio Grande
Basin Summit convened by IBWC and [CELA??] could provide a starting
point for the GEF consortium.

 Sally  Spener added that the IBWC U.S. Section is involved in the
Minnow restoration project and recently met with their Mexican IBWC
colleagues and Mexican Natural Protected Areas staff to enhance the
international aspects and cooperation on this type of project. She noted
that the Mexican bureaucratic structures are not the same as those in
the U.S., which is a challenge to binational cooperation in the border
area.

Chair Ganster said that the GNEB did not control the purse strings, but
could make recommendations based the on growing research knowledge and
the capacity in BECC and NADBank, and the universities.  Chair Ganster
introduced the next speaker, David Schanbacher as a leading expert on
air quality in Texas and who had spent several years with the chemical
and oil and gas industries.

Speaker Presentations

Regional Haze in Texas Big Bend Area

David Schanbacher, Chief Engineer, Texas Commission on Environmental
Quality (TCEQ), said his department covered State Implementation Plan
(SIPs) on clean air, TMDL (Total Maximum Daily Load) water quality and
compliance, Bays and Estuaries, and toxicology. He introduced Margaret
Earnest, a colleague who was available to help answer questions on air
quality. Mr. Schanbacher described regional haze as consisting of small
atmospheric particles, sulfates, nitrates, organic carbon, black carbon,
and soil dust, which absorb and scatter light.  Particles travel
thousands of miles, so it is a national and international problem. Much
of the pollution comes from the production, burning, and usage of
organic or fossil fuels or substances.

Some legislative and regulatory steps taken to reduce emissions include:

In the late 60’s, Texas adopted rules to address emissions that reduce
visibility.

In 1972, a new source review program mandated that new air pollution
sources had 	to get an air quality permit and meet the Best Available
Control Standards.

In 1999, Texas Senate Bill 7 deregulated the utility industry, but
enabled the state to 	request that facilities that had not gone through
the permitting process to cut their 	nitrogen oxide emissions by 50
percent and their sulphur dioxide emissions by 25 	percent.

The Texas Emission Reduction Program (TERP) gives grants and financial
incentives to companies that buy cleaner equipment and retire dirty
equipment. The 	Federal Government regulates mobile sources of
pollution, but locomotives and 	trucks who operate in the impaired areas
have received funding from Texas.

Federal legislative programs regulated by EPA that affect Texas include
Re-formulated Gasoline (RFG) to reduce ozone, Clean Air Interstate Rule
(CAIR) to reduce power plant reductions of SO2 and NOX, and the 1999
Federal Regional Haze Rule to improve visibility in national parks and
scenic areas using the Best Available Retrofit technology (BART). The
CAIR regulations should help reduce air pollution in Texas coming from
other states and vice versa. Texas has made good progress in reducing
NOx emissions since 2000 and CAIR will help lower SO2 emissions in
Texas. Mr. Schanbacher discussed the U. S. and Texas reduction goals for
SO2 by 2010 and 2015, those for NOx in 2009 and 2015. All old and new
plants are covered under the cap, but plants can buy allowances from
other states.

To reduce haze under BART, Texas pre-screened and modeled 120 sources
for particulates and about half of them were required to do further work
to determine if they are subject to BART rules. Each facility subject to
BART would have to do an engineering analysis and plan to reduce
pollution using Federal criteria.  The plans would be reviewed and
approved by TCEQ and then sent to EPA for approval. The overall goal is
to reach natural background visibility by 2064.

In Texas, regional haze needs to be decreased by 16 to 18 deci-views (an
EPA visibility measure). Texas works with other states in the middle of
the country through the Central States Regional Air Planning Association
(CENRAP) to model the amount and sources affecting regional haze.
Particulate matter in the air includes both chemicals and soil and these
are affected by weather patterns. Texas has many monitors that measure
the particulate matter coming into the state. The regional haze SIP is
due in December, 2007. The BART rule was proposed to the three-member
TCEQ Commission in 2006, presented for public comment and would be
revised by TCEQ and forwarded to the Commission for adoption in January
2007.

Mr. Schanbacher suggested members look at the EPA Regional Haze Rule
website, subscribe to the TCEQ ListServe, look at the TCEQ website, and
provided his email address for further information.

Questions and Comments

Vidal Davila, Big Bend National Park, asked if the modeling had been
done to determine if the new coal-fired plants would affect the Big Bend
Region.  Mr. Schanbacher answered that new plants are subject to the cap
and there is an incentive not to buy allowances on the open market.
Margaret Earnst replied that EPA’s estimate of future emissions is
used for new power plants. Sally Spener asked if reductions would have
to come from existing plants.  Mr. Schanbacher said that since the cap
was exceeded now, reductions would have to come from existing coal-fired
plants some of which are at the same sites and new plants.

Chair Ganster asked: What percentage of haze-causing pollutants comes
from Mexican sources? Mr. Schanbacher estimated roughly one-third, but
TCEQ is focused on Texas sources. Stephen Niemeyer commented that Mexico
has a big problem in the Monterrey area, but may find it difficult to
worry about clear views when they have so many social and environmental
problems.

Carl Edlund commented that having two systems to quantify
pollution—SIPs and EPA’s CAIR—makes it difficult to estimate
impacts, especially with trading of emission credits. Mr. Schanbacher
responded that financial incentives should reduce the need to buy caps.
The Electrical Reliability Council of Texas (ERCOT) is an electrical
grid inside Texas that limits the transmission of power outside Texas
and due to a limited demand older plants could be shut down in favor of
new cleaner plants.

Douglas Smith asked if the reduction in SO2 and NOx related to the
reduction in hazy days. Mr. Schanbacher did not have that information,
but thought that SO2 reductions should be greatly affected by the new
rules because most of the coal-fired plants did not have to meet the 25
percent reduction under Senate Bill 7 in 2000.

In response to a question from Mr. Bennett about mercury emissions, Mr.
Schanbacher said that mercury is covered under the Clean Air Mercury
Rules, which should help to reduce elemental mercury from lignite or
sub-bituminous coal burning plants. Oxidized mercury is regulated under
CAIR. New technology to reduce mercury should be available by Phase 2.

Changing Physical Template of our Shared Rivers

Jack Schmidt, Professor, Utah State University, described his background
in management of large river systems, such as the Colorado River, the
Green River, and the Snake River, and the effects of water resources on
endangered species. Restoring the big national and trans-national rivers
is serious public policy.  Decisions made on changing operations of dams
and rivers affect water and electric resources and the environment
downstream.  Targets for restoration have to be viewed from the
standpoint of the whole watershed. For example, the Rio Grande in the
Big Bend region is affected by  the Rio Conchos as well as agricultural
and recreational developments.

Dr. Schmidt illustrated the changes in the Rio Grande with a series of
slides comparing the 1937 photos with today. Present management and uses
have changed the river from a wide, braided sandy river to a much
narrower channel overgrown with vegetation. The width in some sections
has narrowed by four or five meters in the last three years. Water
quantity and flow and the changes in sediment determine the size of a
river channel, its aquatic habitats and its flood plain, and other
ecological effects.

The first major block of irrigation diversions was in the San Luis
Valley of southern Colorado and this caused water supply problems in the
late 1800s for Mexico. Prior to 1915, irrigation diversions in central
New Mexico and El Paso reduced the amount of water entering the Rio
Conchos. In 1916, a large dam was built on the Rio Conchos River in
Mexico. These dams controlled flood waters and provided water for
agriculture, but lowered the mean flow of water in Big Bend National
Park. Between 1932 and 1940, the flow at the Presidio was zero. Dr.
Schmidt illustrated the effects on the average river flow from 1900 from
human efforts to control water. The flood regime that used to reshape
the channel has dwindled to almost nothing. Sedimentation and non-native
plants have increased the banks and narrowed the river.

Dr. Schmidt posed a major question of whether the present hydrological
system should be accepted or reversed. The steady release of water from
the dams on the Conchos does the most damage to aquatic in-stream
habitats. He will provide advice to the NPS, the IBWC and the State
Department to help them determine which flow regime would be best to
meet water management objectives and values for Big Bend National Park.

Questions and Comments

David Randolph asked how an extraordinary drought or a lack of
hurricanes would have affected the water level in the last decade. Dr.
Schmidt agreed that if there were no hurricanes and long periods of
drought, they would affect the water levels in the Rio Conchos, but the
long-term averages are more affected by human diversions.

Jennifer Montoya asked if the volume of water coming out of the Rio
Conchos was about the same as the upper watershed before 1915. While a
lot of people say that the “Forgotten River” went dry anyway, World
Wildlife Fund research indicates otherwise. Dr. Schmidt said the USGS
gauging data shows a lot of water coming out of that part of the river
prior to 1915.  The Rio Grande has a history of channel changes on the
U. S.-Mexico border and changes due to drought and extreme floods, but
the current river’s condition is not mainly due to these types of
causes.

Mr. Niemeyer commented that between 1995 and 2004 there was water in the
reservoirs on the Conchos, but the Mexican government choose not to
release it. In the 1950’s, Mexico delivered 350,000 acre-feet of water
 to the U.S. every year, but Mexico uses the water for its own purposes.
Also, during late summer, huge floods occurred in El Paso/Juarez, but
very little water reached the Big Bend stretch. Dr. Schmidt added that
unless the river channel is changed to a wide, shallow channel, the
Silvery Minnow will not be restored.

Controlling Invasive Plants along the Rio Grande

In introducing the next speaker, Mark Briggs, World Wildlife Fund (WWF),
Chair Ganster Mark, reminded members that GNEB had sent a comment letter
to the President and Congress regarding invasive species along the Rio
Grande.

Mark Briggs discussed his work as a consultant on the control of
invasive species such as salt cedar in Big Bend and gave a brief
introduction to the GNEB field trip to Boquillas Canyon on Wednesday.
He described salt cedar, Tamarix ramosissima, as a plant native to
Northern Africa and Eurasia that was introduced into this area in the
1930s and is successfully out-competing native species and choking
several major rivers in the Southwestern U.S. and northern Mexico.  Mr.
Briggs illustrated the effect of salt cedar on several rivers with a
series of slides.

The salt cedar impact is mainly due to the changing hydrological regime
of the affected rivers. The building of dams, such as Elephant Butte on
the Rio Grande in New Mexico, changed the timing of the river flows and
affected the seed-producing of cottonwoods and willows that depended on
a heavy spring flow. Salt cedar is perfectly adapted to the changes in
flow caused by the dams and a higher level of salinity. The overgrowth
of the salt cedar has resulted in a huge biomass, not previously known
from native plants, and an increase in water usage from plant growth and
evapotranspiration.

Destroying the plants to increase water for downstream users might only
work for the short run and may have unintended consequences such as
increasing evaporation from cleared areas, lack of water savings because
plants grow outside of the river areas, various effects on wildlife
habitat, and sedimentation effects. Research has shown that a mixture of
salt cedar and native species provides a high quality wildlife habitat.
There is a variety of tools available for removing salt cedar such as
machetes, aerial spraying, herbicides, and the leaf beetle, but
objectives and plans need to be carefully considered to ensure positive
effects. Plans need to identify clear objectives, consequences, best
locations, strategies, and the effect of managing flow releases in a
more natural manner, and monitoring of long-term effects.

There are two pilot projects for removal of salt cedar and a giant
reed—one in Colorado Canyon Boquillas and one in Boquillas Canyon.
Another objective is to re-establish native plants, such as desert
willow, huisache, acacia, and mesquite. Irrigation techniques were used
to help establish 600 native plants. Cutting and herbicides were used to
destroy the cedar and the giant cane. The projects are costly and affect
small areas of five to ten acres. The Boquillas Canyon project was a
joint project with PROFAUNA, using trained Mexican workers. The major
benefit of small projects is they are tangible and people can see
progress and then become supportive and politically active in
encouraging long-term ecological and hydrologic changes for the benefit
of the environment.

Michael Dorsey asked about (1) long-term cost benefit analysis, (2)
re-growth, (3) effects on birds, (4) commitment from Mexico, and (5)
long-term commitment. Mr. Briggs said that no cost benefit analysis was
being done, but some other projects have data relating planting to
wildlife use. Re-growth would be mitigated or prevented if the native
species survive and success may depend on better water flow. The
Southwestern Willow Flycatcher can use willows to nest in and is not
native to Texas. The World Wildlife Fund and the Rio Grande Institute
are pushing the IBWC to provide temporary work permits to workers on
both sides of the river. Follow-through is planned, but it depends on
funding.

Mr. Stefanov asked about the recent signing by President Bush of the
Cedar/Russian Olive Control Act. Mr. Briggs thought the funding could be
helpful if careful planning was done.  DFO Koerner asked if there were
public education programs to help people understand the benefits of
non-native species removal, since the pictures make them look
beneficial. Mr. Briggs responded that information kiosks and videos were
available for park users, and that the WWF is providing information to
newspapers and journals. Mr. Davila added that a video was being
produced to distribute to Federal land-management agencies, state and
local governments, and a wayside exhibit was placed at Boquillas Canyon
trail.

Adjournment: There being no further business, the meeting was adjourned
at 5:28 p.m.

Day 2: Thursday, October 26, 2006						(9:37 a.m.)

Business Meeting

Board Members Present: Paul Ganster, Ph.D., Chair, Christopher P. Brown,
Ph. D., Michael P. Dorsey, Edward Elbrock, Jennifer A. Montoya, Stephen
M. Niemeyer, P.E., David Randolph, Douglas S. Smith, Robert Varady,
Ph.D., Ann Marie A. Wolf

Federal Members/Alternates/Team Members Present: Carl Edlund, Gary
Robinson, Sally Spener, James Stefanov, Carlos Rincon, Ph.D.,

EPA/OCEM  Members Present: Rafael DeLeon, Elaine M. Koerner, DFO,
Geraldine Brown

Welcome

Elaine Koerner, DFO, opened the business meeting of the Good Neighbor
Environmental Board (GNEB) by stating the importance of this business
meeting in selecting the next year’s meeting sites and the Eleventh
Report theme and topics.

Approval of Minutes from the July 18-19, 2006 Meeting

Chair Ganster said that the last meeting minutes were well done, quite
complete, and reflected the intense discussions.  He asked for approval
of the minutes of the San Diego, July 18-19, 2006 meeting with minor
corrections to be sent to DFO Koerner. Stephen Niemeyer agreed with
Chair Ganster but asked whether Linda Lawson was at the meeting either
day and if Rosario Marin was present on the first day. DFO Koerner said
she would check the records, but that names are checked against the
registration lists.  Dr. Brown moved and Mr. Niemeyer seconded the
approval of the minutes. The minutes were approved unanimously with
minor corrections to be forwarded to DFO Koerner.

Invitations for Public Input on the Tenth Report Draft Recommendations

DFO Koerner announced that the meeting was open for public comments on
the GNEB Tenth Report to the President and Congress.  There being no
public comments, DFO Koerner noted a change in the timeline from October
20 to 22, 2006, and then suggested guidelines for the review process.
She thanked board members for their excellent input on the draft report.
Their suggestions were incorporated in an interim report which was sent
to the Board on Sunday evening. Chair Ganster would act as editor for
the first part of November and would incorporate comments received by
November 3, 2006. The written consensus process should be completed by
November 24, 2006.

In early December, the official consensus will be obtained through a
teleconference of Board members. The business report still needs to be
written. The goal is to have a printer-ready version to EPA by January
5th, 2007.  This would provide time for senior Administration officials
to receive the Report before its release to the public at the March GNEB
meeting.  Chair Ganster asked David Randolph if he would review the
Spanish translation.

Jennifer Montoya asked Gary Robison from the Department of Homeland
Security (DHS) if he could review the human crossing section.  Mr.
Robison responded that he would comment on the report from the
standpoint of the Office of the Border Patrol and DHS.  Chair Ganster
thought that some of the ideas from this meeting could be incorporated.
He reminded members that their input was important, but that additional
departmental approvals were not necessary. Mr. Randolph hoped that it
would be possible to adjust the report in light of Congressional actions
in regard to border fencing.  DFO Koerner thought that the Introduction
section could add some caveats as to the timing of the final written
report. Mr. Niemeyer added that even though he had recused himself from
Dr. Brown’s comment letter, in the past week, Governor Perry announced
his opposition to fencing in the border areas except on either side of
major cities.

DFO Koerner asked for specific fixes to the report, if needed, but not
minor edits, as the report editing would be done by a contractor. She
asked members to review text that had been deleted because it was
objectionable to some board members. The goal is to use language that is
agreeable to everyone. The report, as written, is too long and DFO
Koerner asked if the Hazardous Materials Crossings introduction could be
shortened. Mr. Niemeyer said he would edit that section with approval of
the work group. DFO Koerner thanked workgroup members and their leaders,
Jennifer Montoya, Christopher Brown, and Stephen Niemeyer.

Selections of Locations and Dates for 2007 Board Meetings

Chair Ganster stated the need for determining the meeting locations,
dates, and planning groups for the 2007 GNEB meetings—a March meeting
in Washington, D.C. and two border location meetings in the Summer and
Fall. DFO Koerner suggested March 13-14, 2007, for the Washington, D.C.
meeting to coincide with the U.S./Mexico Chamber of Commerce meeting on
March 13, 2007, and provided the date did not conflict with other
meetings. The meeting dates of other meetings such as BECC/NADBank,
appeared to be uncertain, except for the Border 2012 National
Coordinators meeting which was in early May. The GNEB meeting dates
should be spaced three months apart and would need to be separated by
two weeks from other Office of Cooperative Management (OCEM)-staffed
meetings such as the Governmental Advisory Committee (GAC), the National
Advisory Committee (NAC), and the National Advisory Committee on
Environmental Technology (NACEPT).

Other criteria for OCEM/EPA discussed by Rafael DeLeon, DFO Koerner, and
Board members included the costs of three-day meetings, ease of
transportation, casual dress for summer meetings, availability and
timing of field trips, volunteers for planning, facilities, public
access for open meetings, and outreach to Native Americans. OCEM
Director DeLeon said that budgetary concerns would limit the group to
one three-day meeting and two two-day meetings. Also, the government
establishes contracts with airlines for the best available fares, so
these have to be adhered to for transportation.

After considerable discussion, the following meeting times and dates
were determined:

Washington, D.C.: Tuesday, March 13 and Wednesday, March 14, 2007

Brownsville, Texas: Tuesday, July 24 and Wednesday, July 25, 2007

Las Cruces, New Mexico: Wednesday, October 3, and Thursday, October 4,
2007

The planning group members and conference call dates and times for each
group was decided as follows:

Washington, D. C. planning meeting members: Elaine Koerner, Rachel
Poynter 		(State Department) Gary Gillen.

		Washington, D.C. planning meeting conference call: Tuesday, November
28 at 3:00 		p.m.

Brownsville Meeting committee volunteers: Carlos Rincon, Stephen
Niemeyer, Sally 	Spener, James Stefanov, and possibly Karen Chapmen,
former GNEB member.

		Brownsville Meeting conference call: Friday, November 3, 3:00 p.m.,
Eastern 			Standard Time.

Las Cruces, New Mexico planning committee members: Jennifer Montoya,
Edward 	Elbrock, Christopher Brown, Carlos Rincon, and a staff member
from Secretary 	Curry’s office. (Planning conference calls dates and
times to be determined.)

For the length of meetings, the Washington DC meeting would a two-day
meeting, and the Brownsville meeting would be a two-day meeting, with a
field trip and a business meeting on the second day. The Las Cruces
meeting could be a three-day meeting which would allow for field trips
to more distant locations.

Field trip suggestions for the border locations in the Brownsville area
included irrigation systems, sugar cane cooperatives, and wildlife
refuges. Field trip suggestions for the border locations in the Las
Cruces area included Santa Teresa Port of Entry, hurricane effects in
the Valley, and the Malpai Borderlands Group.

For 2008 Board meetings, Ann Marie Wolf suggested Yuma, Arizona, for the
fall meeting, and Edward Elbrock suggested Playas, New Mexico, because
the DHS has a training facility there with conference and meeting
facilities.

Membership Status

DFO Koerner brought up some membership issues related to re-appointments
and length of service. Both Federal and Non-Federal Board appoints are
for two years and several members first and second, two-year terms would
be expiring before the next meeting. She thanked the following members
whose second two-year terms were expiring: Douglas Smith, Amanda
Aguirre, and Ken Ramirez. The following members’ first terms would be
expiring: Stephen Niemeyer, Gary Gillen, David Randolph, and Ann Marie
Wolf.  DFO Koerner thanked them all for their contributions and asked if
anyone had comments.

Douglas Smith thanked Paul Ganster and Elaine Koerner for their
leadership in keeping everyone focused and on track in view of the
different interests and opinions. Mr. Smith added that Sony would pursue
their corporate responsibility and would help to find a representative
from the manufacturing sector.  Dr. Varady asked if there was a rule
about attendance, because he had not met one of the members in three
years. DFO Koerner responded that board members could be removed for
lack of attendance, but that it was complicated to remove someone and
replace them; however, she would try to enforce the rules in the future.

In response to a question from Dr. Brown, on the criteria used for
membership, DFO Koerner said the EPA Administrator makes decisions on
appointments and re-appointments using a very complex set of factors,
including attendance, expertise, and group or departmental
representation.

Board Member Report Outs

U.S. Department of Interior: James Stefanov, USGS, reported on several
mapping updates:

Border Health Project has extended data sets in the areas of land cover,
land use, 	medium resolution, hydrography, transportation, watersheds
and populated places. 	These data sets are available on an internet map
service.

In the Lower Rio Grande Valley, data from U.S. and Mexico has been
integrated into 	a single data set.

Geospatial data from INEGI (National Institute of Statistics, Geography,
and Data 	Processes) is now free and INEGI and CAN (National Water
Commission) are 		updating watershed data on the Mexican side of the
border.

The Southwest Consortium for Environmental Research (SCERP) and USGS
signed 	an agreement to cooperate on a border-wide Geographic
Information System (GIS). 	The USGS is updating border image maps for
the IBWC to help define the 	U.S./Mexico international boundaries.

On March 23, 2006, the National Parks Service (NPS) and SEMARNAT
(Secretariat of the Environment and Natural Resources) in Mexico signed
a joint declaration on seven sister parks. NPS would provide training,
monitoring, interpretive materials and some surplus equipment to Mexico,
which would help fight invasive species and land fires and would monitor
shared species. Mr. Stefanov added that the new USGS Director is Mark
Meyers, who is supportive of international work.

Arizona-Mexico Commission: David Randolph, Border Coordination Office,
reported on a proposal for a hazardous waste landfill in Sonora near the
Tohono O’odham Reservation and Organ Pipe Monument. This proposal is
opposed by Mexico, the Tohono O’odham Nation, and the Arizona
Department of Environmental Quality. The ADEQ administrator has sent a
letter to EPA supporting the Tohono O’odham Nation’s concerns.  ADEQ
has received a $100,000 grant under Border 2012 to clean up solid waste
deposited by undocumented migrants in four border counties, the Tohono
O’odham Nation, and the Cocopah Nation.

New Mexico State University: Christopher Brown, Ph.D., reported on
several research projects at his laboratory at New Mexico State
University including:

A contract for GIS work on bilateral transportation planning project at
the border in 	cooperation with the Joint Working Committee of the U.S.
Federal Highway 	Administration and its Mexican counterpart,` Secretaria
de Comunicaciones y 	Transporte.

A Border Infrastructure Needs Assessment starting next year and a Border
GIS 	Infrastructure Project for SCERP to be finished at the end of the
year.

A letter of intent to submit a proposal for a Flood Risk Assessment
Project for the 	Paso del Norte was accepted.  The work will be done in
conjunction with 	Gilbert Anaya, IBWC, and Jean Parcher, USGS.

The binational GIS data work of SCERP and USGS was featured at the
Binational 	Summit in El Paso, with 35 of 75 attendees from Mexico.

The web GIS data is being used for water resource data in work with the
Paso del 	Norte Watershed Council on a binational GIS database project.

A U. S. Department of Agriculture project on cost-sharing mechanisms of
binational waste water treatment plants at the border.

Texas Commission on Environmental Quality (TCEQ):  Stephen M. Niemeyer,
P.E., reported on four training projects involving the U.S.-Mexico
border area, as follows:

Workshops for grant applicants of Border 2012 Region VI funds and for
EPA grants

Training on the new EPA Hazardous Waste Manifest in El Paso, Laredo, and
Brownsville on November 2, 8, and 9, respectively, working toward one
national manifest and involving Mexican generators.

On November 9 and 10, Mexico’s Social Development Agency, SEDESOL,
will have a conference solid waste management and TCEQ will provide a
speaker on municipal solid waste management.

On November 14, TCEQ and EPA have invited Mexican hospital and clinic
staff to a workshop called Hospitals for a Healthy Environmen,t to learn
how to manage hospital waste in a safe and efficient manner.

DFO Koerner reported for three Board members who were unable to attend
the meeting: Rosendo Treviňo, Department of Agriculture (USDA), Shannon
Sorzano, Housing and Urban Development (HUD), and Amanda Aguirre,
Regional Center for Border Health, Inc.

USDA: Rosendo Treviňo’s report was a description of a Mexican
Initiative, a USDA Natural Resources Conservation Service project called
“Helping People Help the Land.”

Housing and Urban Development (HUD): Shannon Sorzano sent a written
report on three projects:

1)A Colonias GIS Mapping Project that maps and allocates census
statistics to the Colonias along the southwestern border in New Mexico,
Arizona, and California. The current phase is to create a web-based
mapping and data dissemination tool that will provide access to colonia
boundaries and data and will serve as a basis for collaboration and data
sharing across Federal, state, and local jurisdictions.

2)A Migrant Farm Worker Mapping Project to target and better serve the
migrant seasonal farm worker community by mapping their geographical
locations. Data is being gathered from the Department of Health and
Human Resources (HHS) and USDA’s migrant worker housing locations to
allow for concentration of services.

3)The Hispanic Serving Institutions Assisting Communities (HSIAC), HUD,
grants to the University of Texas at Brownsville and Texas Southwest
College to create a business incubator to assist in neighborhood
revitalization, housing, and economic development. Another HSIAC grant
is the Home Ownership and Money Management Education grant to the
University of Texas Pan American (UTPA) targeted to families in colonias
in the Lower Rio Grande Valley.

Regional Center for Border Health, Inc.: Amanda Aguirre, CEO/President,
sent a report stating that she is participating with Governor Napolitano
and the ADEQ on the Yuma Asthma Children’s Forum. The GNEB’s Annual
Report was distributed at the Ninth National Promotoras Conference in
San Diego, California in August to 300 participants. ADEQ and the San
Luis Rio Colorado-Sonora-Yuma, Arizona Binational Health and Environment
Council is developing a first year calendar for the border with drawings
from elementary school children from both sides of the border. They are
also sponsoring a binational training program of volunteer bomberos
between the cities of Yuma, Somerton, and San Luis Rio Sonora, Mexico.
Ms. Aguirre participated in the Arizona-Mexico Legislative tour in
Sonora with Sonoran diputados who discussed border infrastructure and
emergency response.

World Wildlife Fund: Jennifer Montoya, U.S. Program Director, discussed
the WWF, IBWC Elephant Butte Irrigation District, the Bureau of
Reclamation, and the Army Corps of Engineers, who are cooperating on the
assessment of alternatives to the management of the canalization portion
of the Rio Grande Project covering a 100-mile stretch from the Caballo
Reservoir to the American Canal. The project would use a hydrologic
model to look at over-bank flooding, which could restore some wetland
habitat.

A second project is on water quality and coliform bacteria from animal
fecal waste in the Rio Grande River in cooperation with the Paso del
Norte Watershed Council under a New Mexico Environment Department grant.
The State provided $150,000 to WWF to reach out to more stakeholders to
participate in their Watershed Council.  WWF was instrumental in
obtaining a promise from Governor Richardson in New Mexico to
appropriate $7.5 million dollars to enhance wildlife values on New
Mexico’s rivers.

U.S. EPA, Region 6: Carl Edlund, Director of Multimedia Planning and
Permitting, repeated the event relating to Director Marcus Peacock and
President Bush about 50,000 homes that now had clean water or sewage
service. Director Marcus provided a note of thanks and some token
cookies to the team who worked on the project, including Carlos Rincon
and Gilbert Tellez.  In Cuidad Juarez, a million tires have been
recycled into fuel. SEMARNAT, the state of Chihuahua, and EPA have
provided funds to remove 250,000 tires.

For clean air, and related to the Ninth Report, a new truck stop
electrification facility in Laredo was installed to handle about 1,500
trucks, which would cut down idling emissions. Region 6 is celebrating
Western Refining’s move to produce ultra-low sulfur diesel fuel.

Chair Ganster was glad to hear about measurable progress along the
border. He opened the meeting for a discussion of a theme and topics for
the Eleventh Report, which would be led by DFO Koerner.

Selection of Theme and Topics for the Eleventh Report

DFO Koerner suggested four criteria for selecting a theme and topics for
the Eleventh Report, as follows:

1.Relevance to the Board’s mission to advise the President and
Congress on environmental and infrastructure issues.

Relevant expertise of Board members

Timeliness and relevance of the issue to current concerns

Likelihood that recommendations would be helpful to the Administration.

Chair Ganster referred to a list of topics that members had checked off,
based on their expertise and interests, to determine the topics for the
Eleventh Report:

- Natural Hazards and the Environment—3 (+ 4)

- Solid Waste Issues—3 (- 1)

- Innovative Environmental Management Approaches—4 (+ 1 – 1)

- Status of Border 2012—1

- Changes in Border Environmental Infrastructure since NAFTA—1 (+ 1)

Chair Ganster suggested eliminating the last two and discussing the
first three topics. He also asked members to list sub-topics and issues
and in which Board members could be involved. Carlos Rincon noted that
Border 2012 will have a mid-term report which could benefit from input
from GNEB members. Topics 1, 2, and 3 could have other sub-topics
subsumed under them. Members who had not put checks on the list added
their comments and Topic 1—Natural Hazards and the Environment
received 7 votes at this point.

Comments in favor of Topic 1—Natural Hazards and the Environment
included:

Determining the environmental effects of the responses or lack of
responses to 	natural disasters affecting the border area, such as
hurricanes and large storms, fires, 	and earthquakes

Health and environmental effects of flooding of wastewater plants,
medical facilities 	waste disposal, and industrial plant hazardous
wastes.

Availability of expertise of USGS and academic researchers on flood
warning 	systems and binational fire councils

International aspects of invoking the National Incident Command System
by 	Homeland Security due to security concerns during natural disasters

Recent efforts in emergency planning for natural disasters and hazardous
wastes

Relationship to canalization, levee rehabilitation, and flooding of the
environment in 	the Brownsville, Texas area.

Use of Homeland Security’s BOR STAR and BOR TAC, the tactical response
team, 	due to flooding in New Orleans, the Texas coast, and New Mexico.

Limitations in infrastructure in some of Mexico’s border communities
to deal with 	the effects of natural disasters.

Excessive rain in the Lower Rio Grande that leaves pools for mosquito
breeding 	grounds.

DFO Koerner asked how this topic would relate to the Tenth Report on
emergency response and preparedness and what the nature of
recommendations would be.  Sally Spener responded that the
recommendations could deal with joint emergency responses between the
two countries, joint planning, logistical issues, and the increase of
data on detention dikes and ponds in Ciudad Juarez and El Paso. James
Stefanov suggested a possible recommendation relating to bi-national
information integration to help responders know about storm water
structures, contaminants, and other flood hazards. Chair Ganster added
that with the growth of population and land development storm water
run-off problems would increase. Carl Edlund thought that one outcome
could be scenarios for disaster responses. Mr. Dorsey added that the
Eleventh Report could focus on broader disasters than just chemical
emergency responses, such as the effects of earthquakes. DFO Koerner
asked members to broaden the term “Natural Hazards” to include
disasters in general.

Chair Ganster removed his support for Topic 2-Solid Waste Issues in
favor of Topic 1 and asked if anyone wanted to discuss it, but received
no response. The next discussion related to Topic 3, Innovative
Environmental Management Approaches.  Discussion yielded the following
ideas:

The historical perspective of innovative projects that were successful
could lead to 	further positive approaches.

New movements in solid waste, bio-fuels, and air-monitoring could be
reviewed and 	successful efforts could be applied to other places in the
border.

New environmental management systems in manufacturing facilities could
be used 	to set new environmental standards.

The Border 2012 midterm report is not due until 2007.

DFO Koerner asked for ideas on potential recommendations related to this
topic.  Members offered the following ideas:

Successful innovative approaches could be used as a model and tools for
improved 	border management of resources.

Regional comparative analyses could provide advantages in the watersheds
	approach.

Successful management approaches could provide justification for
resources.

Identifying projects that produce results through use of partnerships
would attract 	more funds.

Projects that have proven to be sustainable without special funding
could be used as 	models of success.

Success stories would be helpful for communities.

The BECC/NADBank framework and tools that have been created to work
successfully at the border region, such as the auto map, could help
communities 	improve air quality.

Chair Koerner urged members to be very specific about recommendations
for more funds that would help the administration move forward. Ms.
Montoya thought it was difficult to determine specific recommendations
before the topic was studied in depth; however, one recommendation could
be to loosen immigration restrictions for federal agents at the border.
Another idea, proposed by Dr. Brown, would be a web-enabled database or
catalogue of success stories, contacts, funding sources, and mechanisms.
Chair Ganster said a database would be useful tool, but was beyond the
resources of GNEB.

Chair Ganster asked for a vote on the topics and Natural Hazards and the
Environment received 8 votes and Innovative Environmental Management
received 6 votes. Mr. Niemeyer added that natural hazards affects both
human systems and ecosystems.  Dr. Brown hoped that the losing topic
could be used in the next GNEB Report. The next step was to break the
topic down in to sub-topics and set-up work groups on Natural Hazards.

Ms. Spener suggested two frameworks for setting up workgroups: 1) Divide
the topic by type, such as earthquakes, water, hurricanes and fire, or
2) divide by approaches including infrastructure, health effects, and
responses.  Mr. Randolph thought these could be combined by looking at
topics and then approaches to each topic. Dr. Varady suggested using
strategies, such as information management and partnership building.
DFO Koerner suggested dividing the topic up by the nature of
recommendations, such as data exchange, joint planning, information,
etc.

It was decided to discuss the context of natural hazards in the border
region in the Introduction. Chair Ganster concluded the discussion by
stating that a work group would be needed to formulate the scheme via a
teleconference. DFO Koerner asked for volunteers for an Eleventh Report
workgroup that would have a teleconference in January. The following
members volunteered:  Sally Spener, Stephen Niemeyer, James Stefanov,
Paul Ganster, Jennifer Montoya, Carl Edlund, and Michael Dorsey.

Standard Operating Procedures (SOP) for the GNEB and the Council on
Environmental Quality (CEQ)

Director Rafael DeLeon reviewed the background and processes leading to
standard operating procedures for the GNEB, other OCEM committees, and
CEQ. The purpose was to have an agreed upon process for selecting topics
for board meetings and report recommendations. The basic process is that
Board members would select topics during the summer that would be
forwarded to CEQ for review and approval. DFO Koerner and Director
DeLeon would meet with CEQ officials to explain the list. CEQ could
bring up issues that would require GNEB’s advice and recommendations.
In turn, CEQ would help with subject matter issues and coordination with
other Federal agencies. CEQ would help with pre-release copies of the
Reports, and GNEB would implement the final release and delivery to the
White House or CEQ.  Director DeLeon sees this as a collaborative
process which would bring more visibility to the GNEB. For this year,
the Board topics have been approved by CEQ. DFO Koerner added that, in
the past, the Board has decided independently what issues they would
work on.  Under the new process, there is less autonomy, but she and
Director DeLeon will make every effort to ensure that they will have the
power to select topics.

Dr. Varady asked if there should not be input from Congress on the
issues since GNEB reports to Congress.  Director DeLeon thought they
should continue to work through the CEQ, but that the Reports also would
go to the Speaker of the House and the Border Congressional Caucus as
part of the distribution process.  Dr. Brown stated that he appreciated
the work that they have done to provide the interface, elevate the
exposure and protect the autonomy of the GNEB with CEQ. He was concerned
about whether the GNEB Letters and Reports were actually seen by the
President. Director DeLeon acknowledged that the Reports are statutorily
required and he would like to see that the Chair of GNEB and the EPA
Administrator would be able to deliver the report directly to the
President. He hoped that CEQ would help facilitate this delivery. Chair
Ganster thought that the attention from CEQ resulted from GNEB’s
increasing visibility and credibility and was an indicator of success.

DFO Koerner brought up the need for some further logistical steps on the
Tenth Report. A date in early December was needed for a final consensus
call on the Report. A draft of the Report had been released to a media
source as required by FACA regulations. The work group coordinators need
to have a conference call to decide on the final graphics and cover. The
only time available was determined to be Monday, October 30, at 12:00
Eastern time. Chair Ganster would coordinate Board comments on the draft
interim report.

Adjournment:

There being no further business, Chair Ganster adjourned the meeting at
12:00 p.m.

EPA Good Neighbor Environmental Advisory Board Meeting

Alpine, Texas October 24-26, 2007

EPA Good Neighbor Environmental Advisory Board						  PAGE  26

October 24-26, 2006, Alpine, Texas


[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Pages 23709-23720]
[FR Doc No: 2016-09369]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1206]

Authorization of Emergency Use of an In Vitro Diagnostic Device
for Detection of Ebola Zaire Virus; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of an Emergency Use Authorization (EUA) (the Authorization)
for an in vitro diagnostic device for detection of the Ebola Zaire
virus in response to the Ebola virus outbreak in West Africa. FDA
issued this Authorization under the Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as requested by OraSure Technologies, Inc. The
Authorization contains, among other things, conditions on the emergency
use of the authorized in vitro diagnostic device. The Authorization
follows the September 22, 2006, determination by then-Secretary of the
Department of Homeland Security (DHS), Michael Chertoff, that the Ebola
virus presents a material threat against the U.S. population sufficient
to affect national security. On the basis of such determination, the
Secretary of Health and Human Services (HHS) declared on August 5,
2014, that circumstances exist justifying the authorization of
emergency use of in vitro diagnostic devices for detection of Ebola
virus, subject to the terms of any authorization issued under the FD&C
Act. The Authorization, which includes an explanation of the reasons
for issuance, is reprinted in this document.

DATES: The Authorization is effective as of March 4, 2016.

ADDRESSES: Submit written requests for single copies of the EUA to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the Authorization may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Carmen Maher, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3), as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5),
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents. Among other
things, section 564 of the FD&C Act allows FDA to authorize the use of
an unapproved medical product or an unapproved use of an approved
medical product in certain situations. With this EUA authority, FDA can
help assure that medical countermeasures may be used in emergencies to
diagnose, treat, or prevent serious or life-threatening diseases or
conditions caused by biological, chemical, nuclear, or radiological
agents when there are no adequate, approved, and available
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces of attack with a biological, chemical,
radiological, or nuclear agent or agents; (3) a determination by the
Secretary of HHS that there is a public health emergency, or a
significant potential for a public health emergency, that affects, or
has a significant potential to affect, national security or the health
and security of U.S. citizens living abroad, and that involves a
biological, chemical, radiological, or nuclear agent or agents, or a
disease or condition that may be attributable to such agent or agents;
or (4) the identification of a material threat by the Secretary of
Homeland Security under section 319F-2 of the Public Health Service
(PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or
the health and security of U.S. citizens living abroad.
    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Section 564 of the FD&C Act permits FDA to authorize
the introduction into interstate commerce of a drug, device, or
biological product intended for use when the Secretary of HHS has
declared that circumstances exist justifying the authorization of
emergency use. Products appropriate for emergency use may include
products and uses that are not approved, cleared, or licensed under
sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k),
and 360e) or section 351 of the PHS Act (42 U.S.C. 262). FDA may issue
an EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the

Director of the National Institutes of Health, and the Director of the
Centers for Disease Control and Prevention (to the extent feasible and
appropriate given the applicable circumstances), FDA \1\ concludes: (1)
That an agent referred to in a declaration of emergency or threat can
cause a serious or life-threatening disease or condition; (2) that,
based on the totality of scientific evidence available to FDA,
including data from adequate and well-controlled clinical trials, if
available, it is reasonable to believe that: (A) The product may be
effective in diagnosing, treating, or preventing (i) such disease or
condition; or (ii) a serious or life-threatening disease or condition
caused by a product authorized under section 564, approved or cleared
under the FD&C Act, or licensed under section 351 of the PHS Act, for
diagnosing, treating, or preventing such a disease or condition caused
by such an agent; and (B) the known and potential benefits of the
product, when used to diagnose, prevent, or treat such disease or
condition, outweigh the known and potential risks of the product,
taking into consideration the material threat posed by the agent or
agents identified in a declaration under section 564(b)(1)(D) of the
FD&C Act, if applicable; (3) that there is no adequate, approved, and
available alternative to the product for diagnosing, preventing, or
treating such disease or condition; and (4) that such other criteria as
may be prescribed by regulation are satisfied.
---------------------------------------------------------------------------

    \1\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------

    No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, regulations or guidance are not required for FDA to
implement the EUA authority.

II. EUA Request for an In Vitro Diagnostic Device for Detection of the
Ebola Zaire Virus

    On September 22, 2006, then-Secretary of DHS, Michael Chertoff,
determined that the Ebola virus presents a material threat against the
U.S. population sufficient to affect national security.\2\ On August 5,
2014, under section 564(b)(1) of the FD&C Act and on the basis of such
determination, the Secretary of HHS declared that circumstances exist
justifying the authorization of emergency use of in vitro diagnostic
devices for detection of Ebola virus, subject to the terms of any
authorization issued under section 564 of the FD&C Act. Notice of the
declaration of the Secretary was published in the Federal Register on
August 12, 2014 (79 FR 47141). On February 29, 2016, OraSure
Technologies, Inc. submitted a complete request for, and on March 4,
2016, FDA issued, an EUA for the OraQuick[supreg] Ebola Rapid Antigen
Test, subject to the terms of the Authorization.
---------------------------------------------------------------------------

    \2\ Under section 564(b)(1) of the FD&C Act, the HHS Secretary's
declaration that supports the EUA issuance must be based on one of
four determinations, including the identification by the DHS
Secretary of a material threat under section 319F-2 of the PHS Act
sufficient to affect national security or the health and security of
U.S. citizens living abroad (section 564(b)(1)(D) of the FD&C Act).
---------------------------------------------------------------------------

III. Electronic Access

    An electronic version of this document and the full text of the
Authorization are available on the Internet at http://www.regulations.gov.

IV. The Authorization

    Having concluded that the criteria for issuance of the
Authorization under section 564(c) of the FD&C Act are met, FDA has
authorized the emergency use of an in vitro diagnostic device for
detection of Ebola Zaire virus (detected in the West Africa outbreak in
2014) subject to the terms of the Authorization. The Authorization in
its entirety (not including the authorized versions of the fact sheets
and other written materials) follows and provides an explanation of the
reasons for its issuance, as required by section 564(h)(1) of the FD&C
Act:
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    Dated: April 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09369 Filed 4-21-16; 8:45 am]
 BILLING CODE 4164-01-C