[Congressional Record Volume 157, Number 193 (Thursday, December 15, 2011)]
[Senate]
[Pages S8681-S8688]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS
By Mr. KOHL:
S. 2000. A bill to amend the copyright law to secure the rights of
artists of works of visual art to provide for royalties, and for other
purposes; to the Committee on the Judiciary.
Mr. KOHL. Mr. President, I rise today to introduce the Equity for
Visual Artists Act of 2011. This bill would enable visual artists to
benefit from their copyrights in a meaningful way similar to other
creators of literary and artistic works such as authors, playwrights
and composers. It provides for the payment of a copyright royalty long
recognized in international law to be paid at the time a work of visual
art is sold at auction in the United States. Half of this royalty
payment will go directly to the artists or their estate and the other
half will be made available to nonprofit American art museums as an
endowment to be used by them to purchase the works of living American
artists so that these works may be freely enjoyed by everyone.
Like all authors, the primary legal right of an artist in his or her
work is the copyright. Yet, visual artists stand alone within America's
creative community in their inability to gain any significant income
under existing copyright law. As an example, creators of music will
collect nearly $2 billion in copyright royalty payments this year. By
contrast, America's visual artists receive only a tiny amount of
copyright income, primarily when their works are reproduced in
publications such as museum catalogues. Visual art often generates
money only when the original work itself is first sold. The vast
majority of money-making sales are not by artists themselves but by
collectors, dealers and auction houses who trade in their works after
their first sale. Under current law artists receive no income from
these sales.
For nearly 100 years international copyright law under the Berne
Convention on Literary and Artistic Works, of which the United States
is a party, has given artists a right to royalties each time their
works are resold. However, unlike other rights protected under the
Convention, individual countries are not required to recognize the
artists' resale right. While over 40 other countries, including all
members of the European Union, provide their artists with income from
resale of their works, the United States does not. Under the
Convention's reciprocity rule, these countries will only pay royalties
to artists from countries that also recognize the resale right. As a
result, American artists receive no money from these sales.
In 1990, Congress enacted the Visual Artists Rights Act that asked
the Copyright Office to study the issue of resale royalties and report
back with recommendations. The Copyright Office reported back to
Congress that creation of new artworks would be encouraged by adoption
of the Berne Convention provisions on resale rights, but it recommended
that we wait to see whether the European Union would first require all
of its member countries to join those like France and Germany who had
long provided their artists with such a right. In 2001, the European
Union decided to make resale royalties mandatory throughout its
territory, underpinning the Copyright Office's initial conclusions
about the positive effects of introducing resale rights. In 2006, the
United Kingdom was the last EU country to implement its law.
In order to make the administration of a resale right as simple as
possible, the bill would take 7 percent of any sale $10,000 or more
from only the most public and easily accountable transactions, auction
sales, and divide the amount by artists or their beneficiaries and non-
profit museums to purchase American art. The legislation would apply
only to sales by entities that have $25 million per year of cumulative
sales of visual art. It also excludes entities that solely conduct
business in online auctions over the Internet. The bill gives primary
responsibility for collecting and distributing royalties to non-
governmental collecting societies with oversight by the Copyright
Office and reporting requirements to Congress.
This legislation is a long overdue step in fulfilling our obligation
under the Berne Convention to award visual artists the benefits derived
from the resale of their works, a right that literary and musical
artists have enjoyed for decades. Under current law, visual artists are
denied royalties for lucrative sales of their art, and this bill is a
meaningful start for providing them with just compensation. It is only
fair that, as stipulated by international law, visual artists profit
from the appreciation in value of their work.
Mr. President, I ask unanimous consent that the text of the bill be
printed in the Record.
There being no objection, the text of the bill was ordered to be
printed in the Record, as follows:
S. 2000
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Equity for Visual Artists
Act of 2011''.
SEC. 2. DEFINITIONS.
Section 101 of title 17, United States Code, is amended
by--
(1) inserting after the definition of ``architectural
work'' the following:
``For purposes of section 106(b), `auction' means a public
sale run by an entity that sells to the highest bidder works
of visual art in which the cumulative amount of such works
sold during the previous year is more than $25,000,000 and
does not solely conduct the sale of visual art by the entity
on the Internet.''.
(2) inserting after the definition of ``proprietor'' and
prior to the definition of ``pseudonymous work'' the
following:
``For purposes of section 106(b), `price' is the aggregate of
all installments paid in cash or in-kind by or on behalf of a
purchaser for a work as the result of auction of that
work.'';
(3) inserting at the end of the definition of
``Publication'' the following: ``For purposes of section
106(b), in the case of a work of visual art as defined in
this section, a publication does not include photographic
reproductions or other images of the work, including castings
of a sculptural work, made or distributed prior to January 1,
1978, in connection with the exhibition of such work by a
gallery or museum, whether for purposes of sale of the
original work, or in connection with any publication
authorized by a gallery or museum in possession of the work
regardless of whether such publication was with the consent
of the author. In no other circumstances is a work of visual
art considered to have been published prior to January 1,
1978, unless such publication has been authorized by the
express written consent of the author of such work.'';
(4) inserting after the definition of ``registration'' and
prior to the definition of ``sound recordings'' the
following:
``For purposes of sections 106(b) and 701(b)(5), `sale' means
transfer of ownership or physical possession of a work as the
result of the auction of that work.''; and
(5) amending paragraph (1) of the definition of a ``work of
visual art'' to read as follows:
``(1) a painting, drawing, print, sculpture, or photograph,
existing either in the original embodiment or in a limited
edition of 200 copies or fewer that bear the signature or
other identifying mark of the author and are consecutively
numbered by the author, or, in the case of a sculpture in
multiple cast, carved, or fabricated sculptures of 200 or
fewer that are consecutively numbered by the author and bear
the signature or other identifying mark of the author; or''.
SEC. 3. EXCLUSIVE RIGHTS.
Section 106 of title 17, United States Code, is amended
by--
(1) inserting ``(a)'' before ``Subject to sections 107
through 122''; and
(2) adding at the end the following:
``(b)(1) In this subsection, the term `net royalty' means
the royalty amount collected less administrative expenses of
the visual artists' collecting society. In no case shall the
administrative expenses of the visual artists' collecting
society subtracted from the royalty amount collected exceed
18 percent.
``(2) Whenever a work of visual art is sold as the result
of auction of that work by someone other than the artist who
is the author of the work, the entity that collects the money
or other consideration paid for the sale of the work shall,
within 90 days of collecting such money or other
consideration, pay out of the proceeds of the sale a royalty
equal to 7 percent of the price. Such royalty shall be paid
to a visual artists' collecting society. The collecting
society shall distribute, no fewer than 4 times per year, 50
percent of the net royalty to the artist or his or her
successor as copyright owner. After payment to the artist or
his or her successor as copyright owner, the remaining 50
percent of the net royalty shall be deposited into an escrow
account established by the collecting society for the
purposes of funding purchases by nonprofit art museums in the
United States of works of visual art authored by living
artists domiciled in the United States. The right to receive
such royalty and the obligation to deposit the remaining
share of
[[Page S8682]]
sale proceeds into the escrow account provided in this
subsection may not be waived by the artist or his successor
as copyright owner. Failure of the entity collecting the
money or other consideration resulting from the sale of the
work to pay the royalty provided under this section shall
constitute an infringement of copyright. Any such
infringement shall be subject to the payment of statutory
damages under section 504.
``(3) Paragraph (2) shall not apply to the sale of a work
for a gross sales price of less than $10,000, or in exchange
for property with a fair market value of less than
$10,000.''.
SEC. 4. NOTICE OF COPYRIGHT.
Section 401 of title 17, United States Code, is amended by
adding at the end the following:
``(e) Non Applicability to Works of Visual Art.--The
provisions of this section shall not apply to a work of
visual art.''.
SEC. 5. COPYRIGHT OFFICE.
Section 701(b) of title 17, United States Code, is amended
by--
(1) redesignating paragraph (5) as paragraph (6); and
(2) inserting after paragraph (4) the following:
``(5) Issue regulations governing visual artists'
collecting societies pursuant to section 106(b), which shall,
at a minimum--
``(A) establish a process by which entities would be
determined to be and designated as visual artists' collecting
societies;
``(B) require that a visual artists' collecting society
authorized to administer royalty collections and
distributions under this title shall have had prior
experience in licensing the copyrights of authors of works of
visual art in the United States, or have been authorized by
no fewer than 10,000 authors of works of visual art, either
directly or by virtue of reciprocal agreements with foreign
collecting societies, to license the rights granted under
section 106;
``(C) exclude any entity from being considered a visual
artists' collecting society where, after having been
designated a visual artists' collecting society, the
royalties collected for at least 5 consecutive years have not
been distributed directly to authors after deduction of
administrative expenses;
``(D) establish the methodology and procedures pursuant to
which visual artists' collecting societies shall make grants
to nonprofit museums for the purchase of works with the
escrow funds provided in this section, after notice and
opportunity to comment, including--
``(i) the criteria to be used by the visual artists'
collecting societies for application by nonprofit art museums
for the purchase of works out of the funds held in escrow for
that purpose by such societies;
``(ii) the amount of the maximum grant for the purchase of
an individual work of visual art;
``(iii) the maximum amount that may be granted to a
nonprofit museum; and
``(iv) criteria for the award of grants when the amounts
requested exceed the total amount of funds held in escrow;
``(E) require that each such society provide the Register
of Copyrights with an annual audit of royalty funds collected
under section 106(b)(1) that includes the total amount
received from the sales of works of visual art, the total
amount paid in distributions to artists or, if deceased, to
their successors as owners of copyright, and the total amount
paid in grants to each nonprofit museum for the purchase of
works of visual art; and
``(F) make publicly available an annual report to the
Congress setting forth the total amount of royalties received
by each visual artists' collecting society and the amount
disbursed to each nonprofit art museum receiving a grant or
grants from the escrow funds established by each visual
artists' collecting society.
Except as necessary for the report to Congress required
pursuant to subparagraph (F), the Register of Copyrights
shall not disclose any confidential or proprietary
information provided to it in the annual audits made
available pursuant to this section.''.
SEC. 6. COPYRIGHT OFFICE FEES.
Section 708(a) of title 17, United States Code, is
amended--
(1) by redesignating paragraphs (10) and (11) as paragraphs
(11) and (12), respectively;
(2) by inserting after paragraph (9) the following:
``(10) for expenses associated with carrying out its
responsibilities under section 701(b)(5), provided that such
fees shall be paid out of the total royalty payments received
by collecting societies pursuant to section 106(b), before
deduction of such societies' administrative expenses; and
provided further, that following the initial rulemaking
necessary to carry out its obligations under section
701(b)(5), such fees shall not exceed 5 percent of the total
annual amount of royalties received by such collecting
societies;''; and
(3) in the matter following paragraph (12), as so
redesignated, in the second sentence, by striking ``(10) and
(11)'' and inserting ``(11) and (12)''.
SEC. 7. EFFECTIVE DATE.
This Act and the amendments made by this Act shall take
effect on the date that is 1 year after the date of enactment
of this Act.
F_____
By Mr. WYDEN (for himself and Mr. Merkley):
S. 2001. A bill to expand the Wild Rogue Wilderness Area in the State
of Oregon, to make additional wild and scenic river designations in the
Rogue River area, to provide additional protections for Rogue River
tributaries, and for other purposes; to the Committee on Energy and
Natural Resources.
Mr. WYDEN. Mr. President, today I am pleased to introduce legislation
to expand the Wild Rogue Wilderness Area and expand protections to
Oregon's iconic Rogue River and its tributaries. I am pleased that
Senator Merkley is joining me in this effort, and that Congressman
DeFazio has introduced similar legislation in the House of
Representatives.
The Wild Rogue Wilderness and the Rogue River that runs through it
embody one of the Nation's premier recreation destinations, famous for
the free flowing waters which provide numerous rafting and fishing
opportunities. The headwaters of the Rogue River start in one of
Oregon's other great gems Crater Lake National Park, and the river
ultimately empties into the Pacific Ocean, near Gold Beach on Oregon's
southwest coast. Along that stretch, the Rogue River flows through one
of the most spectacular canyons and diverse natural areas in the United
States. The Rogue River is a world class rafting river, offering
everything from one day trips to week long trips through deep forested
canyons. On the land, the Rogue River trail is also one of Oregon's
most renowned backpacking routes.
The legislation I introduce today, the Rogue Wilderness Area
Expansion Act of 2011, would add 60,000 acres of new wilderness to the
existing Wild Rogue Wilderness. The Wild Rogue Wilderness expansion
would protect habitat for bald eagles, osprey, spotted owls, bear, elk,
cougar, wild coho, wild Chinook, wild steelhead and many others. It
would also ensure these treasured lands are protected for generations
to come.
My legislation would also protect an additional 143 miles of
tributaries that feed the Rogue River with cold clean water; 93 miles
would be designated Wild and Scenic Rivers and an additional 50 miles
would be protected from mining. The areas receiving protection include
Galice Creek, Little Windy Creek, Jenny Creek, Long Gulch, and 36 other
tributaries of the Rogue. The Rogue River is one of Oregon's most
iconic and beloved rivers. It is a river that teems with salmon leaping
up rapids to spawn, and finds rafters down those very same rapids at
other times of the year. The Rogue River is home to runs of coho,
spring and fall Chinook, winter and summer steelhead, and it has the
special distinction of being one of only a handful of rivers in the
country with runs of green sturgeon. In 2008, American Rivers named the
Rogue and its tributaries as the second most endangered river in the
U.S. I am hoping to change that today by introducing legislation to
protect this river and its tributaries.
I previously introduced legislation to protect the Rogue River
tributaries in the last two Congresses. Since that time, I have worked
with the timber industry and conservationists to find a compromise that
protects one of America's treasures with additional wilderness
designations and more targeted protections for the Rogue's tributaries.
I am pleased that nearly 60 local businesses, and over 100
organizations and business in total, support protecting the Wild Rogue,
and that support grows every day. Many of those businesses directly
benefit from the Wild Rogue and the Rogue River. As I often say,
protecting these gems is not just good for the environment, but also
good for the economy. These protected landscapes are powerhouses of the
recreation economy that draws visitors from around the world to this
region and the Rogue River is one of Oregon's most important sport and
commercial fisheries. The Wild Rogue is the second largest salmon
fishery in Oregon behind the Columbia. The Wild Rogue provides the
quality of life and recreational opportunities that create an economic
engine that attracts businesses and brings in tourists from around the
world. The Rogue River supports 450 local jobs in nearby communities
like Grants Pass.
By protecting the Wild Rogue landscape and the tributaries that feed
the mighty Rogue River, Congress will ensure that future generations
can raft, fish, hike and enjoy the Wild Rogue as
[[Page S8683]]
it is enjoyed today and that the recreational economy of this region
remains strong.
I want to express my thanks to the conservation and business
communities of southern Oregon, who have worked diligently to protect
these lands and waters and enable the outdoor recreationists to use and
enjoy these rivers. I look forward to working with my House colleagues
and the bill's supporters to advance our legislation to the President's
desk.
Mr. President, I ask unanimous consent that the text of the bill be
printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
S. 2001
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Rogue Wilderness Area
Expansion Act of 2011''.
SEC. 2. DEFINITIONS.
In this Act:
(1) Commission.--The term ``Commission'' means the Federal
Energy Regulatory Commission.
(2) Map.--The term ``map'' means the map entitled ``Wild
Rogue Wilderness Additions'' and dated December 8, 2011.
(3) Secretary.--The term ``Secretary'' means the Secretary
of the Interior.
(4) State.--The term ``State'' means the State of Oregon.
(5) Wilderness additions.--The term ``Wilderness
additions'' means the land added to the Wild Rogue Wilderness
by section 3(a).
SEC. 3. EXPANSION OF WILD ROGUE WILDERNESS AREA.
(a) Expansion.--In accordance with the Wilderness Act (16
U.S.C. 1131 et seq.), the approximately 60,000 acres of
Bureau of Land Management land, as generally depicted on the
map, is included in the Wild Rogue Wilderness, a component of
the National Wilderness Preservation System.
(b) Map; Legal Description.--
(1) In general.--As soon as practicable after the date of
enactment of this Act, the Secretary shall file a map and
legal description of the wilderness area designated by
subsection (a), with--
(A) the Committee on Energy and Natural Resources of the
Senate; and
(B) the Committee on Natural Resources of the House of
Representatives.
(2) Force of law.--The map and legal description filed
under paragraph (1) shall have the same force and effect as
if included in this Act, except that the Secretary may
correct typographical errors in the map and legal
description.
(3) Public availability.--The map and legal description
filed under paragraph (1) shall be on file and available for
public inspection in the appropriate offices of the Bureau of
Land Management.
(c) Administration.--Subject to valid existing rights, the
Wilderness additions shall be administered by the Secretary
in accordance with the Wilderness Act (16 U.S.C. 1131 et
seq.), except that--
(1) any reference in that Act to the effective date shall
be considered to be a reference to the date of enactment of
this Act; and
(2) any reference in that Act to the Secretary of
Agriculture shall be considered to be a reference to the
Secretary.
(d) Fish and Wildlife.--Nothing in this section affects the
jurisdiction or responsibilities of the State with respect to
fish and wildlife in the State.
(e) Adjacent Management.--
(1) In general.--Nothing in this section creates any
protective perimeter or buffer zone around the Wilderness
additions.
(2) Activities outside wilderness.--The fact that a
nonwilderness activity or use on land outside the Wilderness
additions can be seen or heard within the Wilderness
additions shall not preclude the activity or use outside the
boundary of the Wilderness additions.
(f) Protection of Tribal Rights.--Nothing in this section
diminishes any treaty rights of an Indian tribe.
(g) Withdrawal.--Subject to valid existing rights, the
Wilderness additions are withdrawn from all forms of--
(1) entry, appropriation, or disposal under the public land
laws;
(2) location, entry, and patent under the mining laws; and
(3) disposition under all laws pertaining to mineral and
geothermal leasing or mineral materials.
SEC. 4. WILD AND SCENIC RIVER DESIGNATIONS, ROGUE RIVER AREA.
(a) Amendments.--Section 3(a) of the Wild and Scenic Rivers
Act (16 U.S.C. 1274(a)) is amended by striking paragraph (5)
and inserting the following:
``(5) Rogue, oregon.--
``(A) In general.--The segment of the river extending from
the mouth of the Applegate River downstream to the Lobster
Creek Bridge, to be administered by the Secretary of the
Interior or the Secretary of Agriculture, as agreed to by the
Secretaries of the Interior and Agriculture or as directed by
the President.
``(B) Additions.--In addition to the segment described in
subparagraph (A), there are designated the following segments
in the Rogue River:
``(i) Kelsey creek.--The approximately 4.8-mile segment of
Kelsey Creek from the east section line of T. 32 S., R. 9 W.,
sec. 34, Willamette Meridian, to the confluence with the
Rogue River, as a wild river.
``(ii) East fork kelsey creek.--The approximately 4.6-mile
segment of East Fork Kelsey Creek from the Wild Rogue
Wilderness boundary in T. 33 S., R. 8 W., sec. 5, Willamette
Meridian, to the confluence with Kelsey Creek, as a wild
river.
``(iii) Whisky creek.--
``(I) Recreational river.--The approximately 0.6-mile
segment of Whisky Creek from the confluence of the East Fork
and West Fork to 0.1 miles downstream from road 33-8-23, as a
recreational river.
``(II) Wild river.--The approximately 1.9-mile segment of
Whisky Creek from 0.1 miles downstream from road 33-8-23 to
the confluence with the Rogue River, as a wild river.
``(iv) East fork whisky creek.--
``(I) Wild river.--The approximately 2.6-mile segment of
East Fork Whisky Creek from the Wild Rogue Wilderness
boundary in T. 33 S., R. 8 W., sec. 11, Willamette Meridian.,
to 0.1 miles downstream of road 33-8-26 crossing, as a wild
river.
``(II) Recreational river.--The approximately 0.3-mile
segment of East Fork Whisky Creek from 0.1 miles downstream
of road 33-8-26 to the confluence with Whisky Creek, as a
recreational river.
``(v) West fork whisky creek.--The approximately 4.8-mile
segment of West Fork Whisky Creek from its headwaters to the
confluence with Whisky Creek, as a wild river.
``(vi) Big windy creek.--
``(I) Scenic river.--The approximately 1.5-mile segment of
Big Windy Creek from its headwaters to 0.1 miles downstream
from road 34-9-17.1, as a scenic river.
``(II) Wild river.--The approximately 5.8-mile segment of
Big Windy Creek from 0.1 miles downstream from road 34-9-17.1
to the confluence with the Rogue River, as a wild river.
``(vii) East fork big windy creek.--
``(I) Scenic river.--The approximately 0.2-mile segment of
East Fork Big Windy Creek from its headwaters to 0.1 miles
downstream from road 34-8-36, as a scenic river.
``(II) Wild river.--The approximately 3.7-mile segment of
East Fork Big Windy Creek from 0.1 miles downstream from road
34-8-36 to the confluence with Big Windy Creek, as a wild
river.
``(viii) Little windy creek.--The approximately 1.9-mile
segment of Little Windy Creek from 0.1 miles downstream of
road 34-8-36 to the confluence with the Rogue River, as a
wild river.
``(ix) Howard creek.--
``(I) Scenic river.--The approximately 0.3-mile segment of
Howard Creek from its headwaters to 0.1 miles downstream of
road 34-9-34, as a scenic river.
``(II) Wild river.--The approximately 6.9-mile segment of
Howard Creek from 0.1 miles downstream of road 34-9-34 to the
confluence with the Rogue River, as a wild river.
``(x) Mule creek.--The approximately 6.3-mile segment of
Mule Creek from the east section line of T. 32 S., R. 10 W.,
sec. 25, Willamette Meridian, to the confluence with the
Rogue River, as a wild river.
``(xi) Anna creek.--The approximately 3.5-mile segment of
Anna Creek from its headwaters to the confluence with Howard
Creek, as a wild river.
``(xii) Missouri creek.--The approximately 1.6-mile segment
of Missouri Creek from the Wild Rogue Wilderness boundary in
T. 33 S., R. 10 W., sec. 24, Willamette Meridian, to the
confluence with the Rogue River, as a wild river.
``(xiii) Jenny creek.--The approximately 1.8-mile segment
of Jenny Creek from the Wild Rogue Wilderness boundary in T.
33 S., R. 9 W., sec.28, Willamette Meridian, to the
confluence with the Rogue River, as a wild river.
``(xiv) Rum creek.--The approximately 2.2-mile segment of
Rum Creek from the Wild Rogue Wilderness boundary in T. 34
S., R. 8 W., sec. 9, Willamette Meridian, to the confluence
with the Rogue River, as a wild river.
``(xv) East fork rum creek.--The approximately 1.3-mile
segment of East Rum Creek from the Wild Rogue Wilderness
boundary in T. 34 S., R. 8 W., sec. 10, Willamette Meridian,
to the confluence with Rum Creek, as a wild river.
``(xvi) Wildcat creek.--The approximately 1.7-mile segment
of Wildcat Creek from its headwaters downstream to the
confluence with the Rogue River, as a wild river.
``(xvii) Montgomery creek.--The approximately 1.8-mile
segment of Montgomery Creek from its headwaters downstream to
the confluence with the Rogue River, as a wild river.
``(xviii) Hewitt creek.--The approximately 1.2-mile segment
of Hewitt Creek from the Wild Rogue Wilderness boundary in T.
33 S., R. 9 W., sec. 19, Willamette Meridian, to the
confluence with the Rogue River, as a wild river.
``(xix) Bunker creek.--The approximately 6.6-mile segment
of Bunker Creek from its headwaters to the confluence with
the Rogue River, as a wild river.
``(xx) Dulog creek.--
``(I) Scenic river.--The approximately 0.8-mile segment of
Dulog Creek from its headwaters to 0.1 miles downstream of
road 34-8-36, as a scenic river.
``(II) Wild river.--The approximately 1.0-mile segment of
Dulog Creek from 0.1 miles
[[Page S8684]]
downstream of road 34-8-36 to the confluence with the Rogue
River, as a wild river.
``(xxi) Quail creek.--The approximately 1.7-mile segment of
Quail Creek from the Wild Rogue Wilderness boundary in T. 33
S., R. 10 W., sec. 1, Willamette Meridian, to the confluence
with the Rogue River, as a wild river.
``(xxii) Meadow creek.--The approximately 4.1-mile segment
of Meadow Creek from its headwaters to the confluence with
the Rogue River, as a wild river.
``(xxiii) Russian creek.--The approximately 2.5-mile
segment of Russian Creek from the Wild Rogue Wilderness
boundary in T. 33 S., R. 8 W., sec. 20, Willamette Meridian,
to the confluence with the Rogue River, as a wild river.
``(xxiv) Alder creek.--The approximately 1.2-mile segment
of Alder Creek from its headwaters to the confluence with the
Rogue River, as a wild river.
``(xxv) Booze creek.--The approximately 1.5-mile segment of
Booze Creek from its headwaters to the confluence with the
Rogue River, as a wild river.
``(xxvi) Bronco creek.--The approximately 1.8-mile segment
of Bronco Creek from its headwaters to the confluence with
the Rogue River, as a wild river.
``(xxvii) Copsey creek.--The approximately 1.5-mile segment
of Copsey Creek from its headwaters to the confluence with
the Rogue River, as a wild river.
``(xxviii) Corral creek.--The approximately 0.5-mile
segment of Corral Creek from its headwaters to the confluence
with the Rogue River, as a wild river.
``(xxix) Cowley creek.--The approximately 0.9-mile segment
of Cowley Creek from its headwaters to the confluence with
the Rogue River, as a wild river.
``(xxx) Ditch creek.--The approximately 1.8-mile segment of
Ditch Creek from the Wild Rogue Wilderness boundary in T. 33
S., R. 9 W., sec. 5, Willamette Meridian, to its confluence
with the Rogue River, as a wild river.
``(xxxi) Francis creek.--The approximately 0.9-mile segment
of Francis Creek from its headwaters to the confluence with
the Rogue River, as a wild river.
``(xxxii) Long gulch.--The approximately 1.1-mile segment
of Long Gulch from the Wild Rogue Wilderness boundary in T.
33 S., R. 10 W., sec. 23, Willamette Meridian, to the
confluence with the Rogue River, as a wild river.
``(xxxiii) Bailey creek.--The approximately 1.7-mile
segment of Bailey Creek from the west section line of T. 34
S., R.8 W., sec.14, Willamette Meridian, to the confluence of
the Rogue River, as a wild river.
``(xxxiv) Shady creek.--The approximately 0.7-mile segment
of Shady Creek from its headwaters to the confluence with the
Rogue River, as a wild river.
``(xxxv) Slide creek.--
``(I) Scenic river.--The approximately 0.5-mile segment of
Slide Creek from its headwaters to 0.1 miles downstream from
road 33-9-6, as a scenic river.
``(II) Wild river.--The approximately 0.7-mile section of
Slide Creek from 0.1 miles downstream of road 33-9-6 to the
confluence with the Rogue River, as a wild river.''.
(b) Management.--Each river segment designated by
subparagraph (B) of section 3(a)(5) of the Wild and Scenic
Rivers Act (16 U.S.C. 1274(a)(5)) (as added by subsection
(a)) shall be managed as part of the Rogue Wild and Scenic
River.
(c) Withdrawal.--Subject to valid existing rights, the
Federal land within the boundaries of the river segments
designated under subparagraph (B) of section 3(a)(5) of the
Wild and Scenic Rivers Act (16 U.S.C. 1274(a)(5)) (as added
by subsection (a)) is withdrawn from all forms of--
(1) entry, appropriation, or disposal under the public land
laws;
(2) location, entry, and patent under the mining laws; and
(3) disposition under all laws pertaining to mineral and
geothermal leasing or mineral materials.
SEC. 5. ADDITIONAL PROTECTIONS FOR ROGUE RIVER TRIBUTARIES.
(a) Licensing by Commission.--The Commission shall not
license the construction of any dam, water conduit,
reservoir, powerhouse, transmission line, or other project
works on or directly affecting any stream described in
subsection (d).
(b) Other Agencies.--
(1) In general.--No department or agency of the United
States shall assist by loan, grant, license, or otherwise in
the construction of any water resources project on or
directly affecting any stream segment that is described in
subsection (d), except to maintain or repair water resources
projects in existence on the date of enactment of this Act.
(2) Effect.--Nothing in this subsection prohibits any
department or agency of the United States in assisting by
loan, grant, license, or otherwise, a water resources
project--
(A) the primary purpose of which is ecological or aquatic
restoration; and
(B) that provides a net benefit to water quality and
aquatic resources.
(c) Withdrawal.--Subject to valid existing rights, the
Federal land located within a \1/4\ mile on either side of
the stream segments described in subsection (d), is withdrawn
from all forms of--
(1) entry, appropriation, or disposal under the public land
laws;
(2) location, entry, and patent under the mining laws; and
(3) disposition under all laws pertaining to mineral and
geothermal leasing or mineral materials.
(d) Description of Stream Segments.--The following are the
stream segments referred to in subsection (a):
(1) Kelsey creek.--The approximately 4.5-mile segment of
Kelsey Creek from its headwaters to the east section line of
T. 32 S., R. 9 W., sec. 34.
(2) East fork kelsey creek.--The approximately 0.2-mile
segment of East Fork Kelsey Creek from its headwaters to the
Wild Rogue Wilderness boundary in T. 33 S., R. 8 W., sec. 5.
(3) East fork whisky creek.--The approximately 0.9-mile
segment of East Fork Whisky Creek from its headwaters to the
Wild Rogue Wilderness boundary in T. 33 S., R. 8 W., sec. 11.
(4) Little windy creek.--The approximately 1.2-mile segment
of Little Windy Creek from its headwaters to the west section
line of T. 33 S., R. 9 W., sec. 34.
(5) Mule creek.--The approximately 5.1-mile segment of Mule
Creek from its headwaters to the east section line of T. 32
S., R. 10 W., sec. 25.
(6) Missouri creek.--The approximately 3.1-mile segment of
Missouri Creek from its headwaters to the Wild Rogue
Wilderness boundary in T. 33 S., R. 10 W., sec. 24.
(7) Jenny creek.--The approximately 3.1-mile segment of
Jenny Creek from its headwaters to the Wild Rogue Wilderness
boundary in T. 33 S., R. 9 W., sec. 28.
(8) Rum creek.--The approximately 2.2-mile segment of Rum
Creek from its headwaters to the Wild Rogue Wilderness
boundary in T. 34 S., R. 8 W., sec. 9.
(9) East fork rum creek.--The approximately 0.8-mile
segment of East Fork Rum Creek from its headwaters to the
Wild Rogue Wilderness boundary in T. 34 S., R. 8 W., sec. 10.
(10) Hewitt creek.--The approximately 1.4-mile segment of
Hewitt Creek from its headwaters to the Wild Rogue Wilderness
boundary in T. 33 S., R. 9 W., sec. 19.
(11) Quail creek.--The approximately 0.8-mile segment of
Quail Creek from its headwaters to the Wild Rogue Wilderness
boundary in T. 33 S., R. 10 W., sec. 1.
(12) Russian creek.--The approximately 0.1-mile segment of
Russian Creek from its headwaters to the Wild Rogue
Wilderness boundary in T. 33 S., R. 8 W., sec. 20.
(13) Ditch creek.--The approximately 0.7-mile segment of
Ditch Creek from its headwaters to the Wild Rogue Wilderness
boundary in T. 33 S., R. 9 W., sec. 5.
(14) Long gulch.--The approximately 1.4-mile segment of
Long Gulch from its headwaters to the Wild Rogue Wilderness
boundary in T. 33 S., R. 10 W., sec. 23.
(15) Bailey creek.--The approximately 1.4-mile segment of
Bailey Creek from its headwaters to the west section line of
T. 34 S., R. 8 W., sec. 14.
(16) Quartz creek.--The approximately 3.3-mile segment of
Quartz Creek from its headwaters to its confluence with the
North Fork Galice Creek.
(17) North fork galice creek.--The approximately 5.7-mile
segment of the North Fork Galice Creek from its headwaters to
its confluence with Galice Creek.
(18) Grave creek.--The approximately 10.2-mile segment of
Grave Creek from the confluence of Wolf Creek downstream to
the confluence with the Rogue River.
(19) Centennial gulch.--The approximately 2.2-mile segment
of Centennial Gulch from its headwaters to its confluence
with the Rogue River.
(20) Galice creek.--The approximately 2.2-mile segment of
Galice Creek from the confluence with the South Fork Galice
Creek downstream to the Rogue River.
______
By Mrs. FEINSTEIN (for herself, Mr. Sessions, Mr. Schumer, and
Mr. Cornyn):
S. 2002. A bill to amend the Federal Food, Drug, and Cosmetic Act to
improve the safety of Internet pharmacies; to the Committee on Health,
Education, Labor, and Pensions.
Mrs. FEINSTEIN. Mr. President, I rise today to introduce legislation
that will help stop criminals from exploiting the Internet to illegally
sell prescription drugs. I am pleased to be joined in this effort by
Senator Sessions, Senator Schumer, and Senator Cornyn.
I first became concerned about the issue of illegitimate online
pharmacies in 2001, when one of my constituents, high school student
Ryan Haight, died from an overdose of the controlled substance Vicodin.
He had purchased the Vicodin from a rogue online pharmacy after simply
filling out an online questionnaire in which he described himself as a
25-year-old male suffering from chronic back pain. The doctor
prescribing the drug never met or personally examined Ryan.
Ryan's death was a terrible tragedy. He was a remarkable young man,
an honors student and an athlete. He looked forward to going to
college. Instead, his life was cut short.
In response, I introduced legislation, beginning in 2004, to better
regulate
[[Page S8685]]
the online sale of prescription drugs that are controlled substances.
In 2008, the Ryan Haight Online Pharmacy Consumer Protection Act,
Ryan Haight Act, was enacted into law, and it became effective in April
2009. Senator Sessions was the lead cosponsor on that legislation.
The Ryan Haight Act makes it a violation of the Controlled Substances
Act to dispense a prescription for a controlled substance by means of
the Internet without a practitioner having conducted at least one in-
person medical evaluation of the purchaser. The act also requires
online pharmacies to register with the Drug Enforcement Administration,
DEA, and comply with DEA regulations.
The Ryan Haight Act has helped to prevent illegitimate online sales
of prescribed controlled substances. However, illegitimate online
sellers continue to sell other types of prescription drugs, and
stronger laws are needed to stop them.
The sale of prescription drugs online by web sites acting unlawfully
is a dangerous and widespread problem. The National Association of
Boards of Pharmacy and other non-profit organizations that monitor the
Internet have consistently found that about 96 percent of all Internet
pharmacies don't require a prescription, aren't appropriately licensed,
and sell unregulated drugs.
Theses illegitimate online pharmacies continue to cause serious harm.
The National Association of Boards of Pharmacy reports that from the
start of its Internet Drug Outlet Identification Program in April 2008,
it has received 509 customer inquiries about online prescription drug
sellers, and 21 of those customers have reported injuries. Some of
these injuries were very serious leading to hospitalization, with
customers suffering worsening symptoms caused by the ailment the
medications were intended to treat, as well as severe side effects.
The easy accessibility of prescription drugs through illegitimate
online drug sellers also contributes to a growing prescription drug
abuse problem. A study published in the May 2011 edition of the Journal
of Health Affairs suggests that the growth in high-speed Internet
access has fueled prescription drug abuse. Conducted by investigators
from Massachusetts General Hospital and the University of Southern
California, the study found that, over a 7-year period, States with the
greatest expansion in high-speed Internet access also had the largest
increase in admissions for treatment of prescription drug abuse.
We should be particularly concerned about this problem when it comes
to young people, who are frequently online unsupervised and vulnerable
to rogue drug sellers on the Internet.
Not surprisingly, there is also a significant amount of fraud
associated with illegitimate online drug sellers. Some of these
websites simply take money without providing anything in return.
Web sites that dispense counterfeit drugs are an even more dangerous
problem. These counterfeit drugs are frequently manufactured in
unsanitary conditions and may contain contaminated ingredients, or the
wrong ingredients. A recent CBS News story found that counterfeit drugs
can contain paint, floor wax, and boric acid. So, instead of the
appropriate medicine needed for their health problem, online consumers
are receiving substances that may harm or even kill them.
The legislation I am introducing today will address these problems,
and help stop illegitimate online drug sellers.
There are two main components to the legislation. First, it amends
the Food, Drug and Cosmetic Act to add a definition of ``valid
prescription,'' requiring at least one in-person medical evaluation of
the patient. This is the same approach taken in the Ryan Haight Act
with prescription drugs that are controlled substances. It will prevent
illegitimate online pharmacies from selling drugs over the Internet
with sham prescriptions.
The second critical element is the establishment, by the Food and
Drug Administration, of a registry of legitimate online pharmacy
websites. This will protect consumers who will know that they are
dealing with lawful online pharmacies and help law enforcement crack
down on the illegitimate websites.
The exploitation of the Internet by rogue online drug sellers
continues to be a dangerous and deadly problem and we should not wait
for more lives to be lost or ruined before we act.
Consumers deserve access to safe and legitimate online pharmacies and
protection from illegitimate websites that sell counterfeit or
otherwise illegitimate medication, and I urge my colleagues to support
this legislation.
Mr. President, I ask unanimous consent that the text of the bill be
printed in the Record.
There being no objection, the text of the bill was ordered to be
printed in the Record, as follows:
S. 2002
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Online Pharmacy Safety
Act''.
SEC. 2. FINDINGS.
Congress finds that--
(1) consumers in the United States are targeted by
organized international crime networks that use Internet
websites to sell illegal and often dangerous drugs under the
guise of being legitimate online pharmacies;
(2) illegal online drug sellers offer products that do not
meet the safety standards established by United States laws,
and recent reports from the National Association of Boards of
Pharmacy show that 92 to 95 percent of Internet websites
offering to sell prescription medications online are
illegitimate and operate in clear violation of United States
laws enacted to protect patients;
(3) criminals are attracted to the high profit margin of
business through illegitimate online drug sales, as
counterfeit drug sales alone are estimated to have generated
$75,000,000,000 in 2010, an increase of 92 percent from 2005;
(4) the World Health Organization estimates that 50 percent
of the prescription medicines sold online by Internet
websites that hide their physical address are counterfeit;
(5) research by The Partnership at Drugfree.org found that
1 in 6 consumers in the United States, a total of about
36,000,000 Americans, has bought or currently buys
prescription medication online without a valid prescription;
(6) the prevalence of illegal online drug sellers, and
their sale of counterfeit or otherwise illegitimate
medicines, is a growing public health threat;
(7) people have been seriously injured or killed by
products sold by illegal online drug sellers;
(8) the accessibility of controlled substances and other
drugs without a valid prescription by illegal online drug
sellers contributes to a growing prescription drug abuse
problem in the United States that is endangering teenagers
and public health;
(9) the anonymous and unregulated nature of the Internet
contributes to the counterfeit drug trade and enables
counterfeit medicines to reach United States consumers
through illegitimate online drug sellers posing as legitimate
pharmacies;
(10) counterfeit drugs that are sold through illegal online
drug sellers are manufactured by criminals who deliberately
and fraudulently misrepresent the product in order to trick
consumers into thinking they are purchasing a legitimate and
safe medicine;
(11) these counterfeit drugs are frequently manufactured in
unsanitary conditions and may contain the wrong ingredients,
lack active ingredients, have insufficient or contaminated
active ingredients, or contain too many active ingredients;
(12) counterfeit drugs obtained from illegal online drug
sellers have been found to contain harmful ingredients
including arsenic, boric acid, brick dust, cement powder,
chalk dust, floor polish, leaded road paint, nickel, shoe
polish, and talcum powder;
(13) United States citizens deserve access to safe and
legitimate online pharmacies and protection from illegal
Internet websites that sell counterfeit or otherwise
illegitimate medication;
(14) while the Ryan Haight Online Pharmacy Consumer
Protection Act of 2008 (Public Law 110-425) has helped to
prevent illegitimate online sales of prescribed controlled
substances, illegal online sellers continue to sell other
types of prescription drugs and stronger laws are needed to
stop them; and
(15) greater education and awareness regarding illegal
online drug sellers will help to protect the United States
drug supply chain from infiltration by unregulated and
counterfeit products.
SEC. 3. VALID PRESCRIPTIONS.
Section 503(b) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353(b)) is amended--
(1) in paragraph (1), in the matter following subparagraph
(B), by striking ``shall be dispensed'' and all that follows
through ``the pharmacist.'' and inserting the following:
``shall be dispensed only pursuant to a valid prescription
that is (i) a written prescription of a practitioner licensed
by law to administer such drug; (ii) an oral prescription of
such practitioner which is reduced promptly to writing by the
pharmacist; (iii) an electronic prescription issued by a
practitioner licensed by law to administer such
[[Page S8686]]
drug; or (iv) the refill of any such written, oral, or
electronic prescription if such refilling is authorized by
the prescriber either in the original prescription,
electronic prescription, or by oral order which is reduced
promptly to writing by the pharmacist.''; and
(2) by adding at the end the following:
``(6) In this paragraph:
``(A) The term `valid prescription' means a prescription
that is issued for a legitimate medical purpose in the usual
course of professional practice by--
``(i) a licensed practitioner who has conducted at least 1
in-person medical evaluation of the patient, subject to
paragraph (7);
``(ii) a covering practitioner; or
``(iii) a practitioner engaged in the practice of
telemedicine.
``(B)(i) The term `in-person medical evaluation' means a
medical evaluation that is conducted with the patient in the
physical presence of the practitioner, without regard to
whether portions of the evaluation are conducted by other
health professionals.
``(ii) Nothing in clause (i) shall be construed to imply
that 1 in-person medical evaluation demonstrates that a
prescription has been issued for a legitimate medical purpose
within the usual course of professional practice.
``(C) The term `covering practitioner' means, with respect
to a patient, a licensed practitioner who conducts a medical
evaluation (other than an in-person medical evaluation) at
the request of a licensed practitioner who--
``(i) has conducted at least 1 in-person medical evaluation
of the patient or an evaluation of the patient through the
practice of telemedicine, within the previous 24 months; and
``(ii) is temporarily unavailable to conduct the evaluation
of the patient.
``(D) The term `practice of telemedicine' has the meaning
given that term in section 102 of the Controlled Substances
Act.
``(7) For purposes of paragraph (6), an in-person medical
evaluation of the patient is not required if--
``(A) the prescribing practitioner is issuing a
prescription or dispensing a legend drug in accordance with
the Expedited Partner Therapy in the Management of Sexually
Transmitted Diseases guidance document issued by the Centers
for Disease Control and Prevention; or
``(B) the prescription, administration, or dispensing is
through a public health clinic or other distribution
mechanism approved by the State health authority in order to
prevent, mitigate, or treat a pandemic illness, infectious
disease outbreak, or intentional or accidental release of a
biological, chemical, or radiological agent.
``(8) The Secretary may by regulation establish exceptions
to the requirements described in paragraph (6) with respect
to a drug, based on criteria established by the Secretary.''.
SEC. 4. REGISTRY OF LEGITIMATE ONLINE PHARMACY WEBSITES.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 351 et seq.) is amended by inserting after section 510
the following:
``SEC. 510A. REGISTRY OF LEGITIMATE ONLINE PHARMACY WEBSITES.
``(a) Definitions.--In this section:
``(1) Dispensing pharmacy.--The term `dispensing pharmacy'
means a pharmacy that dispenses, distributes, or supplies
prescription drugs pursuant to orders made on, through, or on
behalf of, an online pharmacy website.
``(2) Domain name.--The term `domain name' has the meaning
given that term in section 45 of the Lanham Act (15 U.S.C.
1127).
``(3) Financial transaction provider.--The term `financial
transaction provider' has the meaning given that term in
section 5362(4) of title 31, United States Code.
``(4) Internet website.--The term `Internet website' means
the collection of digital assets, including links, indexes,
or pointers to digital assets, accessible through the
Internet that are addressed relative to a common domain name.
``(5) Legitimate online pharmacy website.--The term
`legitimate online pharmacy website' means an online pharmacy
website that is included in the Registry pursuant to a
designation by the Secretary under this section.
``(6) Online pharmacy website.--The term `online pharmacy
website' means an Internet website that offers, sells,
dispenses, or distributes, or facilitates the sale,
dispensing, or distribution of prescription or other drugs to
consumers.
``(7) Prescription drug.--The term `prescription drug'
means a drug that is subject to section 503(b)(1).
``(b) Establishment of Registry.--The Secretary shall
establish a Registry of Legitimate Online Pharmacy Websites
(referred to in this section as the `Registry') for the
purpose of educating consumers and promoting public health
and safety.
``(c) Criteria.--The Secretary shall designate an online
pharmacy website as a legitimate online pharmacy website, and
include such legitimate online pharmacy website on the
Registry, if the Secretary determines that--
``(1) the online pharmacy website is accredited by the
United States National Association of Boards of Pharmacy
Verified Internet Pharmacy Practice Sites program; or
``(2) the online pharmacy website meets each of the
following requirements:
``(A) Prescription drugs ordered, sold, dispensed,
distributed, supplied, or provided through or by the online
pharmacy website are sold, dispensed, distributed, supplied,
or provided solely by dispensing pharmacies that are
domiciled in the United States and that maintain pharmacy
licensure, a permit, or registration in good standing in all
United States jurisdictions where such dispensing pharmacies
provide services or are required to maintain such licensure,
permit, or registration.
``(B) Each dispensing pharmacy affiliated with, or that
dispenses, distributes, supplies, or provides prescription or
other drugs on behalf of the online pharmacy website,
maintains a valid Drug Enforcement Administration
registration, unless such registration is not required by
Drug Enforcement Administration regulations.
``(C) Each dispensing pharmacy affiliated with, or that
dispenses, distributes, supplies, or provides prescription
drugs on behalf of the online pharmacy website, dispenses,
distributes, supplies, provides, or offers or attempts to
dispense, distribute, supply, or provide, prescription drugs
only pursuant to a valid prescription (as defined in section
503(b)).
``(D) Each dispensing pharmacy affiliated with, or that
dispenses, distributes, supplies, or provides prescription
drugs on behalf of the online pharmacy website, complies with
applicable Federal and State laws and regulations applicable
to pharmacy practice.
``(E) Each dispensing pharmacy affiliated with, or that
dispenses, distributes, supplies, or provides prescription or
other drugs on behalf of the online pharmacy website, does
not dispense, distribute, supply, provide, offer or attempt
to dispense, distribute, supply, or provide, advertise, or
promote prescription or other drugs that have not been
approved by the Food and Drug Administration.
``(F) The online pharmacy website prominently displays the
following information:
``(i) An accurate United States street address of each
dispensing pharmacy or the corporate or other legal business
entity headquarters of each dispensing pharmacy.
``(ii) An accurate, readily accessible, and responsive
telephone number or other secure accurate means that allows
the consumer to contact or consult with the pharmacist about
his or her prescription drug.
``(G) The online pharmacy website does not make any
statements, regarding the nature of any dispensing pharmacy
or product offered via the website, that are materially
misleading or fraudulent.
``(H) The domain name registration information applicable
to the online pharmacy website is accurate, not anonymous,
and has a logical nexus to each dispensing pharmacy or the
corporate or other legal business headquarters of each
dispensing pharmacy.
``(I) The online pharmacy website, including any operator,
content owner, or domain name registrant of the online
pharmacy website, is not affiliated with, and does not own or
control any other online pharmacy website that violates the
requirements under this paragraph.
``(J) The online pharmacy website, including any operator,
content owner, or domain name registrant of the online
pharmacy website, is not affiliated with, and does not own or
control any other online pharmacy website that violates
Federal or State law.
``(K) Information that would be considered protected health
information under the regulations promulgated under section
264(c) of the Health Insurance Portability and Accountability
Act of 1996 (commonly referred to as the `HIPAA Privacy
Rule') is transmitted by the online pharmacy website and each
dispensing pharmacy affiliated with, or that dispenses,
distributes, supplies, or provides prescription drugs on
behalf of the online pharmacy website, in accordance with the
requirements of such Act, including the use of Secure-Socket
Layer or equivalent technology for the transmission of
protected health information, and the online pharmacy website
displays its privacy policy and that such policy complies
with the requirements of the HIPAA Privacy Rule.
``(L) The online pharmacy website complies with other
requirements as determined appropriate by the Secretary, in
consultation with other Federal and State agencies
responsible for regulating the practice of pharmacy.
``(d) Process.--
``(1) Application.--The Secretary shall develop an
application process through which an interested operator,
content owner, or domain name registrant of an online
pharmacy website may apply for inclusion on the Registry.
Such an application shall be submitted in such form and
manner as required by the Secretary and shall include, at a
minimum, information to determine whether the online pharmacy
website satisfies the criteria described under subsection
(c). The Secretary shall not charge a fee for submission of
an application.
``(2) Identification without application.--
``(A) In general.--The Secretary shall take reasonable
steps to identify online pharmacy websites for which no
application has been submitted under paragraph (1) and
evaluate whether these online pharmacy websites satisfy the
criteria described under subsection (c).
``(B) Compliance confirmed.--In cases where satisfaction of
the criteria described under subsection (c) can be verified
without the receipt of an application, an online pharmacy
website that the Secretary determines to satisfy such
criteria may be designated as a legitimate online pharmacy
website and
[[Page S8687]]
included on the Registry and the operator, content owner, or
domain name registrant of such online pharmacy website shall
be notified of such placement.
``(C) Additional information required.--In cases where
satisfaction of the criteria described under subsection (c)
cannot be verified without additional information or some
corrective action by the online pharmacy website operator,
content owner, or domain name registrant, the online pharmacy
website shall not be designated as a legitimate online
pharmacy website or placed on the Registry until the
additional information is received by the Secretary and the
Secretary determines that all applicable and necessary
corrective actions have been taken.
``(3) Regulations regarding application process.--
``(A) In general.--The Secretary shall promulgate
regulations--
``(i) to establish the timeframes applicable to informing
online pharmacy website operators, content owners, or domain
name registrants that submit an application under paragraph
(1) of the acceptance or denial of such application;
``(ii) to address what information may be shared with or
withheld from online pharmacy website operators, content
owners, or domain name registrants that submit such an
application regarding corrective actions that would need to
be taken to establish compliance with the Registry
requirements;
``(iii) to establish an appeal process giving online
pharmacy website operators, content owners, or domain name
registrants that submit such an application the ability to
request a second review of the application to determine
compliance with the Registry requirements; and
``(iv) to address other procedural matters regarding the
receipt and evaluation of applications submitted under
paragraph (1) as the Secretary determines necessary.
``(B) Limitation regarding appeals process.--The appeals
process established under subparagraph (A)(iii) shall in no
case require the Secretary--
``(i) to disclose information that may impede an ongoing or
potential criminal or regulatory investigation; or
``(ii) to provide an opportunity for appeal in cases where
the Secretary determines, in the Secretary's sole discretion,
that the violation of a Registry requirement is materially
significant, such a violation is not likely to be curable, or
the applicant has engaged in a pattern of violations of
Federal or State law.
``(4) Authority and process for removal from registry.--
``(A) In general.--The Secretary shall have the authority
to remove an online pharmacy website from the Registry--
``(i) upon determination that the online pharmacy website
is not in compliance with the criteria as established by this
section;
``(ii) upon determination that the online pharmacy website
was mistakenly included in the Registry; or
``(iii) for good cause as determined by the Secretary based
on credible evidence.
``(B) Process.--If the Secretary determines that an online
pharmacy website shall be removed from the Registry under
subparagraph (A), the Secretary shall provide notice to the
operator, content owner, or domain name registrant of the
online pharmacy website of the determination, the date of the
removal of the website from the Registry, and the reasons for
removal.
``(C) Regulations for appeal process.--
``(i) In general.--The Secretary shall promulgate
regulations that provide the operator, content owner, or
domain name registrant of an online pharmacy website removed
from the Registry the ability to appeal the removal and to
provide information to correct matters that served as basis
for removal from the Registry. Such regulations shall provide
a reasonable time period to correct the grounds for removal.
``(ii) Limitation regarding appeals process.--The appeals
process established under clause (i) shall in no case require
the Secretary--
``(I) to disclose information that may impede an ongoing or
potential criminal or regulatory investigation; or
``(II) to provide an opportunity for appeal in cases where
the Secretary determines, in the Secretary's sole discretion,
that the violation of a Registry requirement is materially
significant, such a violation is not likely to be curable, or
the applicant has engaged in a pattern of violations of
Federal or State law.
``(e) Contracts With Private Entities.--
``(1) In general.--The Secretary may enter into contracts
with the United States National Association of Boards of
Pharmacy or other private entities to--
``(A) review applications submitted under subsection (d)(1)
and evaluate whether the online pharmacy website satisfies
the criteria described under subsection (c);
``(B) on an ongoing basis, review and identify online
pharmacy websites for which no application has been submitted
under subsection (d)(1) and evaluate whether these online
pharmacies satisfy the criteria described under subsection
(c);
``(C) make recommendations to the Secretary as to whether
an online pharmacy website, either through application or
through identification under subparagraph (B), satisfies the
criteria under subsection (c);
``(D) notify the Food and Drug Administration of online
pharmacy websites that do not to satisfy such criteria; and
``(E) provide services to maintain the Registry.
``(2) Contracting.--In contracting with entities under this
subsection, the Secretary--
``(A) may waive such provisions of the Federal Acquisition
Regulation, except for provisions relating to confidentiality
of information, as necessary for the efficient implementation
of this subsection and for selecting such entities; and
``(B) shall select entities that have demonstrated a
history of competency in reviewing, evaluating, and
determining the legitimacy of online pharmacy websites, based
on standards approved by the United States National
Association of Boards of Pharmacy.
``(3) Terms of contract.--A contract with an entity under
this subsection shall include such terms and conditions as
specified by the Secretary, including the following:
``(A) The entity shall monitor the Internet on an ongoing
basis in order to sufficiently maintain a current list of
legitimate online pharmacy websites for consideration by the
Secretary.
``(B) On at least a monthly basis, the entity shall submit
to the Secretary an updated list of legitimate online
pharmacy websites recommended for inclusion on the Registry.
``(f) Use of Registry.--
``(1) Public availability.--The Secretary shall--
``(A) make the Registry available to Internet advertising
services, financial transaction providers, domain name
registries, domain name registrars, other domain name
authorities, information location tool service providers, and
others as determined necessary and appropriate by the
Secretary to promote public health and safety;
``(B) make the Registry available to consumers and other
interested persons through publication on the Internet
website of the Food and Drug Administration; and
``(C) specify the Registry criteria used to designate
legitimate online pharmacy websites on the Internet website
of the Food and Drug Administration.
``(2) Consumer education.--The Secretary shall--
``(A) engage in a campaign to educate consumers on the
availability and use of the Registry to promote public health
and safety through means as determined appropriate and
necessary by the Secretary, which may include radio,
television, print media, and Internet public service
announcements; and
``(B) make consumer education materials available, on the
Internet website of the Food and Drug Administration and in a
consumer-friendly form and manner, regarding how to safely
purchase drugs over the Internet.
``(g) Refusal of Service; Immunity.--
``(1) Refusal of service.--A domain name registry, domain
name registrar, other domain name authority, financial
transaction provider, information location tool service
provider, or Internet advertising service, acting in good
faith based on the Registry, may cease or refuse to provide
services to an online pharmacy website that is not included
on the Registry.
``(2) Immunity from liability.--An entity described in
paragraph (1), including the directors, officers, employees,
or agents of such entity, that, acting in good faith, ceases
or refuses to provide services to an online pharmacy website
that is not listed on the Registry shall not be liable to any
party under any Federal or State law for such action.
``(3) Immunity from suit.--No cause of action shall lie in
any court or administrative agency against any entity
described in paragraph (1), including the directors,
officers, employees, or agents of such entity, that, acting
in good faith, ceases or refuses to provide services to an
online pharmacy website that is not included on the
Registry.''.
SEC. 5. FUNDING.
There is authorized to be appropriated such sums as may be
necessary to carry out this Act (and the amendments made by
this Act).
SEC. 6. EFFECTIVE DATE.
This Act (and the amendments made by this Act) shall take
effect on the date that is 180 days after the date of
enactment of this Act.
______
By Mr. UDALL of New Mexico (for himself, Mr. Bingaman, Mr.
Inouye, and Ms. Landrieu).
S. 2004. A bill to grant the Congressional Gold Medal to the troops
who defended Bataan during World War II; to the Committee on Banking,
Housing, and Urban Affairs.
Mr. UDALL of New Mexico. Mr. President, last week we marked the 70th
anniversary of the attack on Pearl Harbor, an event that led to the
U.S. into the Second World War. But that wasn't the only important 70th
anniversary commemorated last week. Seventy years ago, on December 8,
1941, the day after the attack on Pearl Harbor, halfway across the
world the long battle for control of the strategically important
country of the Philippines began.
This is a battle that began in the air and on the sea, but would
ultimately see the surrendered American and Filipino troops forced on a
brutal death
[[Page S8688]]
march, languishing in substandard POW camps, and in many cases,
succumbing to malnourishment, mistreatment, and disease.
It is on behalf of all of these soldiers that I introduce legislation
to honor the Defenders of Bataan, a peninsula on the island of Luzon
where the battle ended, but the hellish journey began, with a
Congressional Gold Medal. They are most deserving and this honor is, I
believe, long overdue.
Soon after the air and naval battle for the Philippines began, the
Japanese would land a sizable force to take control of Luzon. Ten days
later the Japanese began their main offensive into the island.
On Christmas Eve, 1941, General MacArthur put War Plan Orange 3 into
effect. This plan called for some troops to delay the Japanese advance
as the greater force withdrew into Bataan. According to historical
documents, the purpose of the plan was to keep Manila Bay from Japanese
control until the U.S. Navy could reopen the supply lines that had been
cut off after the attack on Pearl Harbor.
With the supply lines cut off, troops also had no hope of
reinforcements. Despite this logistical nightmare, they valiantly
fought to defend the Philippines. For months, against all odds, they
held back the enemy advance. The Japanese, hoping for a swift victory,
were forced to slow the pace of their Pacific strategy. The delay
enabled U.S. and allied forces the chance to regroup in the Pacific and
prepare for the eventual liberation of occupied Pacific islands and the
Philippines.
But by April of 1942, the defenders of Bataan were malnourished and
exhausted. With no hope of overcoming the overwhelming conditions, they
were ordered to surrender. While many followed the order to lay down
their arms, others still fought to disrupt the Japanese by forming
guerrilla units to maintain the opposition.
One such guerrilla leader was Oklahoma native and Choctaw Warrior Lt.
Colonel Edward McClish, who, according to the U.S. Navy's historical
website, ``had an organization of more than 300 soldiers, with four
machine guns, 150 rifles, and six boxes of ammunition.''
Following capture, the defenders of Bataan suffered three years of
intense hardship. Many would not survive. They would be forced to
endure what became known as the horrendous 65-mile Bataan Death March.
They would languish in substandard POW camps, where their
malnourishment worsened and disease was rampant. Many others would be
shipped to Japan on the dreaded hell ships. One such ship, the Arisan
Maru, claimed nearly 1,800 American lives.
For us New Mexicans, the events of Bataan strike home particularly
hard. Eighteen hundred men from New Mexico's 200th and 515th regiments
left their homes to fight. Approximately half returned. These soldiers,
largely of Hispanic origin, earned the honor of being the first to fire
and defend the Philippines on December 8. A special group, they were
successors to the New Mexico National Guardsmen who made up part of
Teddy Roosevelt's famed ``Rough Riders'' from the Spanish-American war.
One of these men, Eliseo Lopez, a Bataan defender who was born in
Springer, NM, endured all the horrors Bataan had to offer. A member of
the 200th Coast Artillery Regiment he trained at Ft. Bliss and was
deployed to Manila before war broke out. He fought the Japanese on
Bataan. He survived the Death March to Camp O'Donnell and was moved to
Cabanatuan prison camp. He was taken on a hell ship to Japan, and was
forced to labor in a copper mine until he was rescued in September of
1945. Mr. Lopez died this past November at the age of 92. His obituary
alone is a record of the tremendous service to the United States given
by the Bataan defenders.
In New Mexico, we continue to honor and respect our Bataan Defenders.
We remember their suffering. We take pride in their heroism. Every year
we commemorate their sacrifice with a march at White Sands Missile
Range. Other States, such as Missouri, have similar marches. In April,
Missouri will honor their Bataan veterans with a march on the Katy
Trail State Park.
The people of the United States and Philippines are forever indebted
to Eliseo Lopez and the other men who served with him and endured the
similar horrors. They represented the best of America. They hailed from
diverse locales, but were united in their valor and in their devotion
to their country. Their courage and tenacity during the first four
months of World War II, and their perseverance during 3 years of
imprisonment truly deserves the recognition of a Congressional Gold
Medal. I urge my colleagues to join me in supporting this legislation.
____________________