Congressional Record, Volume 153 Issue 29 (Thursday, February 15, 2007)

[Congressional Record Volume 153, Number 29 (Thursday, February 15, 2007)]
[Senate]
[Pages S2025-S2111]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

By Mr. PRYOR:
S. 602. A bill to develop the next generation of parental control
technology; to the Committee on Commerce, Science, and Transportation.
Mr. PRYOR. Mr. President, I wish to introduce two communications
bills. First, I am introducing the Child Safe Viewing Act, a bill to
develop the next generation of parental control technology. Last year,
following several hearings and forums on decency, I concluded that the
V-Chip is not an adequate solution for parents to prevent their
children from viewing adult content, especially in a world of 500
channels and video streaming.
During the 1996 Telecommunications Act debate, President Clinton
urged inclusion of a mandatory V-Chip device, and in collaboration with
Congress, the FCC, and the entertainment industry, the V-Chip was born.
The V-Chip was an important beginning to control child access to adult
material. Over a decade has passed since the 1996 act, and the world of
communications has changed. However, the issues that inspired the V-
Chip continue to exist today for not only television but for the
Internet and other video streaming devices.
The Child Safe Viewing Act is a pragmatic approach to addressing the
pitfalls of video content not intended for kids, and it acts on current
law. It simply directs the Federal Communications Commission to begin a
proceeding on the requirements in section 551 of the V-Chip law.
Section 551 states that the Commission shall take action on alternative
blocking technology as it is developed. This mandate is clear and the
time has come. We must engage in this issue now to ensure that families
have the tools to keep inappropriate and sometimes dangerous material
out of their children's view.
I am also introducing ED 1.0, a bill to advance online higher
education opportunities for minorities. Last Congress, Senator Allen
and I introduced a bill that would establish a digital and wireless
network technology program for minority-serving institutions, and it
was reported favorably by the Commerce Committee. Regrettably, I am
concerned that the cost of the bill will prohibit it from moving in
this Congress. But the needs to this Nation's minorities are not
standing still.
ED 1.0 would allow some of our goals to move forward now by creating
a pilot online degree program at four minority-serving institutions.
African-American, Hispanic, and tribal serving colleges and
universities in socially and economically disadvantaged areas would be
eligible to participate in this program to help define what works in
ensuring that minorities are obtaining higher education degrees.
With the high costs of networks and limited availability of
resources, the program would provide a national ``lessons learned''
about how to develop and implement flexible degree programs in fields
such as health or education, which are currently underserved in the
disadvantaged community. The goals of ED 1.0 will make education a
reality for thousands of Americans, and I hope this bill will have the
support of my colleagues.
______

By Mr. LAUTENBERG (for himself, Mr. Hagel, Mr. Kerry, and Mrs.
Lincoln):
S. 604. A bill to amend title 10, United States Code, to limit
increases in the certain costs of health care services under the
heaalth care programs of the Department of Defense, and for the
purposes; to the Committee on Armed Services.
Mr. LAUTENBERG. Mr. President, I rise to introduce the Military
Health

[[Page S2026]]

Care Protection Act along with my colleagues, Senators Hagel, Kerry,
and Lincoln.
This important legislation will keep the Pentagon from dramatically
raising health care fees on active duty military personnel, National
Guard, Reserves, retirees and their families.
Our bill will limit increases to TRICARE military health insurance
enrollment fees, deductibles, and pharmacy co-payments for those
military retirees who are enrolled in TRICARE. Under this legislation,
increases in these health care fees cannot exceed the rate of growth in
uniformed services beneficiaries' military compensation, thereby
protecting beneficiaries from an undue financial burden.
Our bill will also cap increases to TRICARE military health insurance
pharmacy co-payments at current levels for those active duty military
personnel, National Guard, Reserves members, and their families. Under
this legislation, increases in such fees also cannot exceed the rate of
growth in uniformed services beneficiaries' military compensation.
Just last week, the Department of Defense (DOD) submitted its Fiscal
Year 2008 budget to Congress. Within that budget, a cut of $1.86
billion was made to TRICARE out of the Defense Health Program budget.
Such a cut would require a doubling of fees on senior enlisted retirees
and a tripling of such fees for officer retirees. This would mean
increases of up to $1,000 annually for some military retirees. While
the Department of Defense temporarily halted plans to raise fees last
year at the direction of Congress, we are again faced with this
challenge. We must pass legislation now that limits the amount of any
health care increase and protects beneficiaries from extreme health
care fee increases in the future.
With this bill, Senator Hagel and I reiterate our commitment to our
troops and future veterans by assuring them that just as they protected
us, we will take care of them when their service ends.
Last year, Congress rejected the same increases that the Pentagon is
proposing again for this year. I ask the support of my colleagues to
pass this legislation this year to prevent these significant increases
permanently.
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. 604

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 ``Military Health Care
Protection Act''.

SEC. 2. FINDINGS AND SENSE OF CONGRESS.

(a) Findings.--Congress makes the following findings:
(1) Career members of the uniformed services and their
families endure unique and extraordinary demands, and make
extraordinary sacrifices, over the course of 20-year to 30-
year careers in protecting freedom for all Americans.
(2) The nature and extent of these demands and sacrifices
are never so evident as in wartime, not only during the
current Global War on Terrorism, but also during the wars of
the last 60 years when current retired members of the Armed
Forces were on continuous call to go in harm's way when and
as needed.
(3) The demands and sacrifices are such that few Americans
are willing to bear or accept them for a multi-decade career.
(4) A primary benefit of enduring the extraordinary
sacrifices inherent in a military career is a range of
extraordinary retirement benefits that a grateful Nation
provides for those who choose to subordinate much of their
personal life to the national interest for so many years.
(5) Many private sector firms are curtailing health
benefits and shifting significantly higher costs to their
employees, and one effect of such curtailment is that retired
members of the uniformed services are turning for health care
services to the Department of Defense, and its TRICARE
program, for the health care benefits in retirement that they
earned by their service in uniform.
(6) In some cases, civilian employers establish financial
incentives for employees who are also eligible for
participation in the TRICARE program to receive health care
benefits under that program rather than under the health care
benefits programs of such employers.
(7) While the Department of Defense has made some efforts
to contain increases in the cost of the TRICARE program, a
large part of those efforts has been devoted to shifting a
larger share of the costs of benefits under that program to
retired members of the uniformed services.
(8) The cumulative increase in enrollment fees,
deductibles, and copayments being proposed by the Department
of Defense for health care benefits under the TRICARE program
far exceeds the 33-percent increase in military retired pay
since such fees, deductibles, and copayments were first
required on the part of retired members of the uniformed
services 11 years ago.
(9) Proposals of the Department of Defense for increases in
the enrollment fees, deductibles, and copayments of retired
members of the uniformed services who are participants in the
TRICARE program fail to recognize adequately that such
members paid the equivalent of enormous in-kind premiums for
health care in retirement through their extended sacrifices
by service in uniform.
(10) Some of the Nation's health care providers refuse to
accept participants in the TRICARE program as patients
because that program pays them significantly less than
commercial insurance programs, and imposes unique
administrative requirements, for health care services.
(11) The Department of Defense has chosen to count the
accrual deposit to the Department of Defense Military Retiree
Health Care Fund against the budget of the Department of
Defense, contrary to the requirements of section 1116 of
title 10, United States Code.
(12) Senior officials of the Department of Defense leaders
have reported to Congress that counting such deposits against
the budget of the Department of Defense is impinging on other
readiness needs of the Armed Forces, including weapons
programs, an inappropriate situation which section 1116 of
title 10, United States Code, was intended expressly to
prevent.
(b) Sense of Congress.--It is the sense of Congress that--
(1) the Department of Defense and the Nation have a
committed obligation to provide health care benefits to
retired members of the uniformed services that exceeds the
obligation of corporate employers to provide health care
benefits to their employees;
(2) the Department of Defense has many additional options
to constrain the growth of health care spending in ways that
do not disadvantage retired members of the uniformed services
who participate or seek to participate in the TRICARE
program, and should pursue any and all such options rather
than seeking large increases for enrollment fees,
deductibles, and copayments for such retirees, and their
families or survivors, who do participate in that program;
(3) any percentage increase in fees, deductibles, and
copayments that may be considered under the TRICARE program
for retired members of the uniformed services and their
families or survivors should not in any case exceed the
percentage increase in military retired pay; and
(4) any percentage increase in fees, deductibles, and
copayments under the TRICARE program that may be considered
for members of the uniformed services who are currently
serving on active duty or in the Selected Reserve, and for
the families of such members, should not exceed the
percentage increase in basic pay for such members.

SEC. 3. LIMITATIONS ON CERTAIN INCREASES IN HEALTH CARE COSTS
FOR MEMBERS OF THE UNIFORMED SERVICES.

(a) Pharmacy Benefits Program.--Section 1074g(a)(6) of
title 10, United Stated Code, is amended by adding at the end
the following new subparagraph:
``(C) The amount of any cost sharing requirements under
this paragraph may not be increased in any year by a
percentage that exceeds the percentage increase of the most
recent increase in retired pay for members of the armed
forces under section 1401a(b)(2) of this title. To the extent
that such increase for any year is less than one dollar, the
accumulated increase may be carried over from year to year,
rounded to the nearest dollar.''.
(b) Premiums for TRICARE Standard for Reserve Component
Members Who Commit to Service in the Selected Reserve.--
Section 1076d(d)(3) of such title is amended--
(1) by striking ``The monthly amount'' and inserting ``(A)
Subject to subparagraph (B), the monthly amount''; and
(2) by adding at the end the following new subparagraph:
``(B) Effective as of October 1, 2007, the percentage
increase in the amount of the premium in effect for a month
for TRICARE Standard coverage under this section may not
exceed a percentage equal to the percentage of the most
recent increase in the rate of basic pay authorized for
members of the uniformed services for a year.''.
(c) Copayments Under CHAMPUS.--Paragraph (3) of section
1086(b) of such title is amended in the first sentence by
striking ``during the period beginning on April 1, 2006, and
ending on September 30, 2007.'' and inserting ``after March
31, 2006''.
(d) Prohibition on Enrollment Fees for Certain Persons
Under CHAMPUS.--Section 1086(b) of such title is further
amended by adding at the end the following new paragraph:
``(5) A person covered by subsection (c) may not be charged
an enrollment fee for coverage under this section.''.
(e) Automatic Enrollment for Certain Persons Under
CHAMPUS.--Section 1086(b) of such title is further amended by
adding at the end the following new paragraph:
``(6) A person covered by subsection (c) shall not be
subject to denial of claims for

[[Page S2027]]

coverage under this section for failure to enroll for such
coverage. To the extent enrollment may be required,
enrollment shall be automatic for any such person filing a
claim under this section.''.
(f) Premiums and Other Charges Under TRICARE.--Section
1097(e) of such title is amended--
(1) by inserting ``(1)'' before ``The Secretary of
Defense''; and
(2) by adding at the end the following new paragraph:
``(2) Effective as of October 1, 2007, the percentage
increase in the amount of any premium, deductible, copayment
or other charge prescribed by the Secretary under this
subsection may not exceed the percentage increase of the most
recent increase in retired pay for members and former members
of the armed forces under section 1041a(b)(2) of this
title.''.
______

By Ms. CANTWELL (for herself, Mr. Bingaman, Mrs. Boxer, Mr.
Kennedy, Ms. Landrieu, Mr. Lieberman, Mrs. Lincoln, Ms.
Mikulski, and Mrs. Murray):
S. 605. A bill to amend the Public Health Service Act to promote and
improve the allied health professions; to the Committee on Health,
Education, Labor, and Pensions.
Ms. CANTWELL. Mr. President, early in the 109th Congress I introduced
a bill to address the troubling shortage of allied health professionals
in our country. Sadly, we were unable to act on this bill despite
continuing deficiencies in the health care workforce. That is why,
today, I am reintroducing the Allied Health Reinvestment Act, along
with my good colleagues, Senators Bingaman, Boxer, Kennedy, Landrieu,
Lieberman, Lincoln, Mikulski, and Murray.
Allied health professionals constitute roughly one third of the
American healthcare workforce. These individuals take x-rays, perform
lab tests, and provide emergency services. They help rehabilitate the
injured, manage health records, and ensure patients are eating right.
Allied health professionals are responsible for a critical and diverse
array of functions, working with doctors and nurses to keep patients
healthy.
The allied health professions recognized in this bill include
professionals in the areas of: dental hygiene, dietetics/nutrition,
emergency medical services, health information management, clinical
laboratory sciences/medical technology, cytotechnology, occupational
therapy, physical therapy, radiologic technology, nuclear medical
technology, rehabilitation counseling, respiratory therapy, and speech
language-pathology/audiology. This is by no means a complete list of
allied health professions, which is why the Secretary of Health and
Human Services will have the authority to determine additional
professions that can benefit.
Today, many allied health professions suffer from existing workforce
shortages. The American Hospital Association (AHA) reports vacancy
rates of 18 percent for radiology technicians, 15.3 percent for imaging
technicians, and 12.7 percent for pharmacy technicians. In my State
alone, the Washington State Hospital Association reports vacancy rates
of 14.3 percent for ultrasound technologists, 11.3 percent for
radiology technicians, and 10.9 percent for nuclear medicine
technologists.
These shortages have real consequences for patients, often extending
wait times for important test results or routine examinations. Every
time I meet with hospital officials in my State, I always learn how
patient care is hurt by the lack of available healthcare workers.
Enrollment figures in allied health education programs suggest we
will not have the individuals available to meet the challenges created
by existing shortages. The Association of Schools of Allied Health
Professionals (ASAHP) reports in a 2006 survey of 87 member
institutions that enrollment for a number of allied health programs
have not reached capacity for the seventh straight year. The
Institutional Profile Survey, which the ASAHP conducts every year,
shows under-enrollment by 55 percent in dietetics, 54 percent in health
administration, 49 percent in rehabilitation counseling, 43 percent in
health information management, 38 percent in speech language pathology/
audiology, 33 percent in emergency medical sciences, 26 percent in
nuclear medicine technology, 25 percent in clinical laboratory
sciences/medical technology, and 20 percent in cytotechnology.
These rates cannot continue. On top of existing workforce shortages,
our health system faces a growing senior population, a group that
typically requires more care. The U.S. Census Bureau reports that the
section of our population age 65 and over will begin to rapidly
increase in 2011 when the first of the baby boom generation reaches age
65. This increase will create greater demand on all sectors of the
healthcare workforce.
The bill my colleagues and I introduce today, like the Nurse
Reinvestment Act in the 107th Congress, intends to provide incentives
for individuals to seek and complete high-quality allied health
education and training.
The bill offers allied health education, practice, and retention
grants. Education grants will be used to expand enrollment in allied
health education programs, especially by underrepresented racial and
ethnic minority students, and provide educational opportunities through
new technologies and methods, including distance-learning. Practice
grants will establish or expand allied health practice arrangements in
non-institutional settings to demonstrate methods that will improve
access to primary health care in rural areas and other medically
underserved communities. Retention grants will promote career
advancement for allied health personnel.
Grants will also be made available for health care facilities to
enable them to carry out demonstrations of models and best practices in
allied health for the purpose of developing innovative strategies or
approaches for retention of allied health professionals. These grants
will be awarded in a variety of geographic regions to a range of
different types of facilities, including those in rural, urban, and
suburban areas.
Furthermore, this bill will give the Secretary of HHS, acting through
the Administrator of HRSA, the authority to enter into an agreement
with any institution that offers an eligible allied health education
program to establish and operate a faculty loan fund to increase the
number of qualified allied health faculty. Loans may be granted to
faculty pursuing a full-time course of study or, at the discretion of
the Secretary, a part-time course of study in an advanced degree
program.
Finally, the Allied Health Reinvestment Act will establish a
scholarship program modeled after the National Health Service Corps
that provides scholarships to individuals seeking allied health
education in exchange for service by those individuals in rural and
other medically underserved areas.
The Allied Health Reinvestment Act represents a serious commitment on
our part to confront a problem that will only grow more serious in the
future. Our system of care cannot operate without the dedicated allied
health professionals working today, and we must take the actions
necessary to ensure that there is a strong workforce that can serve in
the future.
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. 605

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 ``Allied Health Reinvestment
Act''.

SEC. 2. FINDINGS AND PURPOSE.

(a) Findings.--Congress makes the following findings:
(1) The United States Census Bureau and other reports
highlight the increased demand for acute and chronic health
care services among both the general population and a rapidly
growing aging portion of the population.
(2) The calls for reduction in medical errors, increased
patient safety, and quality of care have resulted in an
amplified call for allied health professionals to provide
health care services.
(3) Several allied health professions are characterized by
workforce shortages, declining enrollments in allied health
education programs, or a combination of both factors, and
hospital officials have reported vacancy rates in positions
occupied by allied health professionals.
(4) Many allied health education programs are facing
significant economic pressure that could force their closure
due to an insufficient number of students.
(b) Purpose.--It is the purpose of this Act to provide
incentives for individuals to seek

[[Page S2028]]

and complete high quality allied health education and
training and provide additional funding to ensure that such
education and training can be provided to allied health
students so that the United States health care industry with
have a supply of allied health professionals needed to
support the health care system of the United States in this
decade and beyond.

SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

Title VII of the Public Health Service Act (42 U.S.C. 292
et seq.) is amended by adding at the end the following:

``PART G--ALLIED HEALTH PROFESSIONALS

``SEC. 799C. DEFINITIONS.

``In this part:
``(1) Allied health education program.--The term `allied
health education program' means any postsecondary educational
program offered by an institution accredited by an agency or
commission recognized by the Department of Education, or
leading to a State certificate or license or any other
educational program approved by the Secretary. Such term
includes colleges, universities, or schools of allied health
and equivalent entities that include programs leading to a
certificate, associate, baccalaureate, or graduate level
degree in an allied health profession.
``(2) Allied health professions.--The term `allied health
professions' includes professions in the following areas at
the certificate, associate, baccalaureate, or graduate level:
``(A) Dental hygiene.
``(B) Dietetics or nutrition.
``(C) Emergency medical services.
``(D) Health information management.
``(E) Clinical laboratory sciences and medical technology.
``(F) Cytotechnology.
``(G) Occupational therapy.
``(H) Physical therapy.
``(I) Radiologic technology.
``(J) Nuclear medical technology.
``(K) Rehabilitation counseling.
``(L) Respiratory therapy.
``(M) Speech-language pathology and audiology.
``(N) Any other profession determined appropriate by the
Secretary.
``(3) Health care facility.--The term `health care
facility' means an outpatient health care facility, hospital,
nursing home, home health care agency, hospice, federally
qualified health center, nurse managed health center, rural
health clinic, public health clinic, or any similar health
care facility or practice that employs allied health
professionals.

``SEC. 799C-1. PUBLIC SERVICE ANNOUNCEMENTS.

``The Secretary shall develop and issue public service
announcements that shall--
``(1) advertise and promote the allied health professions;
``(2) highlight the advantages and rewards of the allied
health professions; and
``(3) encourage individuals from diverse communities and
backgrounds to enter the allied health professions.

``SEC. 799C-2. STATE AND LOCAL PUBLIC SERVICE ANNOUNCEMENTS.

``(a) In General.--The Secretary shall award grants to
designated eligible entities to support State and local
advertising campaigns that are conducted through appropriate
media outlets (as determined by the Secretary) to--
``(1) promote the allied health professions;
``(2) highlight the advantages and rewards of the allied
health professions; and
``(3) encourage individuals from disadvantaged communities
and backgrounds to enter the allied health professions.
``(b) Eligible Entity.--To be eligible to receive a grant
under subsection (a), an entity shall--
``(1) be a professional, national, or State allied health
association, State health care provider, or association of
one or more health care facilities, allied health education
programs, or other entities that provides similar services or
serves a like function; and
``(2) prepare and submit to the Secretary an application at
such time, in such manner, and containing such information as
the Secretary may require.

``SEC. 799C-3. ALLIED HEALTH RECRUITMENT GRANT PROGRAM.

``(a) Program Authorized.--The Secretary shall award grants
to eligible entities to increase allied health professions
education opportunities.
``(b) Eligible Entity.--To be eligible to receive a grant
under subsection (a), an entity shall--
``(1) be a professional, national, or State allied health
association, State health care provider, or association of
one or more health care facilities, allied health education
programs, or other eligible entities that provides similar
services or serves a like function; and
``(2) prepare and submit to the Secretary an application at
such time, in such manner, and containing such information as
the Secretary may require.
``(c) Use of Funds.--An entity shall use amounts received
under a grant under subsection (a) to--
``(1) support outreach programs at elementary and secondary
schools that inform guidance counselors and students of
education opportunities regarding the allied health
professions;
``(2) carry out special projects to increase allied health
education opportunities for individuals who are from
disadvantaged backgrounds (including racial and ethnic
minorities that are underrepresented among the allied health
professions) by providing student scholarships or stipends,
pre-entry preparation, and retention activities;
``(3) provide assistance to public and nonprofit private
educational institutions to support remedial education
programs for allied health students who require assistance
with math, science, English, and medical terminology;
``(4) meet the costs of child care and transportation for
individuals who are taking part in an allied health education
program at any level; and
``(5) support community-based partnerships seeking to
recruit allied health professionals in rural communities and
medically underserved urban communities, and other
communities experiencing an allied health professions
shortage.

``SEC. 799C-4. GRANTS FOR HEALTH CAREER ACADEMIES.

``(a) In General.--The Secretary shall award grants to
eligible entities to assist such entities in collaborating to
carry out programs that form education pipelines to
facilitate the entry of students of secondary educational
institutions, especially underrepresented racial and ethnic
minorities, into careers in the allied health professions.
``(b) Eligible Entity.--To be eligible to receive a grant
under subsection (a), an entity shall--
``(1) be an institution that offers allied health education
programs, a health care facility, or a secondary educational
institution; and
``(2) prepare and submit to the Secretary an application at
such time, in such manner, and containing such information as
the Secretary may require.

``SEC. 799C-5. ALLIED HEALTH EDUCATION, PRACTICE, AND
RETENTION GRANTS.

``(a) Education Priority Areas.--The Secretary may award
grants to or enter into contracts with eligible entities to--
``(1) expand the enrollment of individuals in allied health
education programs, especially the enrollment of
underrepresented racial and ethnic minority students; and
``(2) provide education through new technologies and
methods, including distance-learning methodologies.
``(b) Practice Priority Areas.--The Secretary may award
grants to or enter into contracts with eligible entities to--
``(1) establish or expand allied health practice
arrangements in noninstitutional settings to demonstrate
methods to improve access to primary health care in rural
areas and other medically underserved communities;
``(2) provide care for underserved populations and other
high-risk groups such as the elderly, individuals with HIV/
AIDS, substance abusers, the homeless, and victims of
domestic violence;
``(3) provide managed care, information management, quality
improvement, and other skills needed to practice in existing
and emerging organized health care systems; or
``(4) develop generational and cultural competencies among
allied health professionals.
``(c) Retention Priority Areas.--
``(1) In general.--The Secretary may award grants to and
enter into contracts with eligible entities to enhance the
allied health professions workforce by initiating and
maintaining allied health retention programs described in
paragraph (2) or (3).
``(2) Grants for career ladder programs.--The Secretary may
award grants to and enter into contracts with eligible
entities for programs--
``(A) to promote career advancement for allied health
personnel in a variety of training settings, cross training
or specialty training among diverse population groups, and
the advancement of individuals; and
``(B) to assist individuals in obtaining the education and
training required to enter the allied health professions and
advance within such professions, such as by providing career
counseling and mentoring.
``(3) Enhancing patient care delivery systems.--
``(A) Grants.--The Secretary may award grants to eligible
entities to improve the retention of allied health
professionals and to enhance patient care that is directly
related to allied health activities by enhancing
collaboration and communication among allied health
professionals and other health care professionals, and by
promoting allied health involvement in the organizational and
clinical decision-making processes of a health care facility.
``(B) Preference.--In making awards of grants under this
paragraph, the Secretary shall give preferences to applicants
that have not previously received an award under this
paragraph and to applicants from rural, underserved areas.
``(C) Continuation of an award.--The Secretary shall make
continuation of any award under this paragraph beyond the
second year of such award contingent on the recipient of such
award having demonstrated to the Secretary measurable and
substantive improvement in allied health personnel retention
or patient care.
``(d) Eligible Entity.--To be eligible to receive a grant
under this section, an entity shall--
``(1) be a health care facility, or any partnership or
coalition containing a health care

[[Page S2029]]

facility or allied health education program; and
``(2) prepare and submit to the Secretary an application at
such time, in such manner, and containing such information as
the Secretary may require.

``SEC. 799C-6. DEVELOPING MODELS AND BEST PRACTICES PROGRAM.

``(a) Authorized.--The Secretary shall award grants to
eligible entities to enable such entities to carry out
demonstration programs using models and best practices in
allied health for the purpose of developing innovative
strategies or approaches for the retention of allied health
professionals.
``(b) Eligible Entity.--To be eligible to receive a grant
under this section, an entity shall--
``(1) be a health care facility, or any partnership or
coalition containing a health care facility or allied health
education program; and
``(2) prepare and submit to the Secretary an application at
such time, in such manner, and containing such information as
the Secretary may require.
``(c) Distribution of Grants.--In awarding grants under
this section, the Secretary shall ensure that grantees
represent a variety of geographic regions and a range of
different types and sizes of facilities, including facilities
located in rural, urban, and suburban areas.
``(d) Use of Funds.--An entity shall use amounts received
under a grant under this section to carry out demonstration
programs of models and best practices in allied health for
the purpose of--
``(1) promoting retention and satisfaction of allied health
professionals;
``(2) promoting opportunities for allied health
professionals to pursue education, career advancement, and
organizational recognition; and
``(3) developing continuing education programs that
instruct allied health professionals in how to use emerging
medical technologies and how to address current and future
health care needs.
``(e) Area Health Education Centers.--The Secretary shall
award grants to area health education centers to enable such
centers to enter into contracts with allied health education
programs to expand the operation of area health education
centers to work in communities to develop models of
excellence for allied health professionals or to expand any
junior and senior high school mentoring programs to include
an allied health professions mentoring program.

``SEC. 799C-7. ALLIED HEALTH FACULTY LOAN PROGRAM.

``(a) Establishment.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, may enter into an agreement with any
institution offering an eligible allied health education
program for the establishment and operation of a faculty loan
fund in accordance with this section (referred to in this
section as the `loan fund'), to increase the number of
qualified allied health faculty.
``(b) Agreements.--Each agreement entered into under this
section shall--
``(1) provide for the establishment of a loan fund by the
institution offering the allied health education program
involved;
``(2) provide for deposit in the loan fund of--
``(A) the Federal capital contributions to the fund;
``(B) an amount provided by the institution involved which
shall be equal to not less than one-ninth of the amount of
the Federal capital contribution under subparagraph (A);
``(C) any collections of principal and interest on loans
made from the fund; and
``(D) any other earnings of the fund;
``(3) provide that the loan fund will be used only for the
provision of loans to faculty of the allied health education
program in accordance with subsection (c) and for the costs
of the collection of such loans and the interest thereon;
``(4) provide that loans may be made from such fund only to
faculty who are pursuing a full-time course of study or, at
the discretion of the Secretary, a part-time course of study
in an advanced degree program; and
``(5) contain such other provisions determined appropriate
by the Secretary to protect the financial interests of the
United States.
``(c) Loan Provisions.--Loans from any faculty loan fund
established pursuant to an agreement under this section shall
be made to an individual on such terms and conditions as the
allied health education program may determine, except that--
``(1) such terms and conditions are subject to any
conditions, limitations, and requirements prescribed by the
Secretary;
``(2) in the case of any individual, the total of the loans
for any academic year made by an allied health education
program from loan funds established pursuant to agreements
under this section may not exceed $30,000, plus any amount
determined by the Secretary on an annual basis to reflect
inflation;
``(3) upon completion by the individual of each of the
first, second, and third year of full-time employment, as
required under the loan agreement, as a faculty member in an
allied health education program, the program shall cancel 20
percent of the principal and interest due on the amount of
the unpaid portion of the loan on the first day of such
employment;
``(4) upon completion by the individual of the fourth year
of full-time employment, as required under the loan
agreement, as a faculty member in an allied health education
program, the program shall cancel 25 percent of the principal
and interest due on the amount of the unpaid portion of the
loan on the first day of such employment;
``(5) the loan may be used to pay the cost of tuition,
fees, books, laboratory expenses, and other reasonable
education expenses;
``(6) the loan shall be repayable in equal or graduated
periodic installments (with the right of the borrower to
accelerate repayment) over the 10-year period that begins 9
months after the individual ceases to pursue a course of
study in an allied health education program; and
``(7) such loan shall--
``(A) beginning on the date that is 3 months after the
individual ceases to pursue a course of study in an allied
health education program, bear interest on the unpaid balance
of the loan at the rate of 3 percent per year; or
``(B) subject to subsection (e), if the allied health
education program determines that the individual will not
complete such course of study or serve as a faculty member as
required under the loan agreement under this subsection, bear
interest on the unpaid balance of the loan at the prevailing
market rate.
``(d) Payment of Proportionate Share.--Where all or any
part of a loan (including interest thereon) is canceled under
this section, the Secretary shall pay to the allied health
education program involved an amount equal to the program's
proportionate share of the canceled portion, as determined by
the Secretary.
``(e) Review by Secretary.--At the request of the
individual involved, the Secretary may review any
determination by an allied health education program under
this section.

``SEC. 799C-8. SCHOLARSHIP PROGRAM FOR SERVICE IN RURAL AND
OTHER MEDICALLY UNDERSERVED AREAS.

``(a) Program Authorized.--The Secretary shall establish a
scholarship program (referred to in this section as the
`program') to provide scholarships to individuals seeking
allied health education who agree to provide service in rural
and other medically underserved areas with allied health
personnel shortages.
``(b) Preference.--In awarding scholarships under this
section, the Secretary shall give preference to--
``(1) applicants who demonstrate the greatest financial
need;
``(2) applicants who agree to serve in health care
facilities experiencing allied health shortages in rural and
other medically underserved areas;
``(3) applicants who are currently working in a health care
facility who agree to serve the period of obligated service
at such facility;
``(4) minority applicants; and
``(5) applicants with an interest in a practice area of
allied health that has unmet needs.
``(c) Program Requirements.--
``(1) Contracts.--Under the program, the Secretary shall
enter into contracts with eligible individuals under which
such individuals agree to serve as allied health
professionals for a period of not less than 2 years at a
health care facility with a critical shortage of allied
health professionals in consideration of the Federal
Government agreeing to provide to the individuals
scholarships for attendance in an allied health education
program.
``(2) Eligible individuals.--In this subsection, the term
`eligible individual' means an individual who is enrolled or
accepted for enrollment as a full-time or part-time student
in an allied health education program.
``(3) Service requirement.--
``(A) In general.--The Secretary may not enter into a
contract with an eligible individual under this section
unless the individual agrees to serve as an allied health
professional at a health care facility with a critical
shortage of allied health professionals for a period of full-
time service of not less than 2 years, or for a period of
part-time service in accordance with subparagraph (B).
``(B) Part-time service.--An individual may complete the
period of service described in subparagraph (A) on a part-
time basis if the individual has a written agreement that--
``(i) is entered into by the facility and the individual
and is approved by the Secretary; and
``(ii) provides that the period of obligated service will
be extended so that the aggregate amount of service performed
will equal the amount of service that would be performed
through a period of full-time service of not less than 2
years.
``(d) Reports.--Not later than 18 months after the date of
enactment of this part, and annually thereafter, the
Secretary shall prepare and submit to the appropriate
committees of Congress a report describing the program
carried out under this section, including statements
regarding--
``(1) the number of enrollees by specialty or discipline,
scholarships, and grant recipients;
``(2) the number of graduates;
``(3) the amount of scholarship payments made;
``(4) which educational institution the recipients
attended;
``(5) the number and placement location of the scholarship
recipients at health care facilities with a critical shortage
of allied health professionals;

[[Page S2030]]

``(6) the default rate and actions required;
``(7) the amount of outstanding default funds of the
scholarship program;
``(8) to the extent that it can be determined, the reason
for the default;
``(9) the demographics of the individuals participating in
the scholarship program; and
``(10) an evaluation of the overall costs and benefits of
the program.

``SEC. 799C-9. GRANTS FOR CLINICAL EDUCATION, INTERNSHIP, AND
RESIDENCY PROGRAMS.

``(a) Program Authorized.--The Secretary shall award grants
to eligible entities to develop clinical education,
internship, and residency programs that encourage mentoring
and the development of specialties.
``(b) Eligible Entities.--To be eligible for a grant under
this section an entity shall--
``(1) be a partnership of an allied health education
program and a health care facility; and
``(2) prepare and submit to the Secretary an application at
such time, in such manner, and containing such information as
the Secretary may require.
``(c) Use of Funds.--An eligible entity shall use amounts
received under a grant under this section to--
``(1) develop clinical education, internship, and residency
programs and curriculum and training programs for graduates
of an allied health education program;
``(2) provide support for faculty and mentors; and
``(3) provide support for allied health professionals
participating in clinical education, internship, and
residency programs on both a full-time and part-time basis.

``SEC. 799C-10. GRANTS FOR PARTNERSHIPS.

``(a) In General.--The Secretary shall award grants to
eligible entities to enable such entities to form
partnerships to carry out the activities described in this
section.
``(b) Eligible Entity.--To be eligible to receive a grant
under this section, and entity shall--
``(1) be a partnership between an allied health education
program and a health care facility; and
``(2) prepare and submit to the Secretary an application at
such time, in such manner, and containing such information as
the Secretary may require.
``(c) Use of Funds.--An eligible entity shall use amounts
received under a grant under this section to--
``(1) provide employees of the health care facility that is
a member of the partnership involved advanced training and
education in a allied health education program;
``(2) establish or expand allied health practice
arrangements in non-institutional settings to demonstrate
methods to improve access to health care in rural and other
medically underserved communities;
``(3) purchase distance learning technology to extend
general education and training programs to rural areas, and
to extend specialty education and training programs to all
areas; and
``(4) establish or expand mentoring, clinical education,
and internship programs for training in specialty care areas.

``SEC. 799C-11. ALLIED HEALTH PROFESSIONS TRAINING FOR
DIVERSITY.

``The Secretary, acting in conjunction with allied health
professional associations, shall develop a system for
collecting and analyzing allied health workforce data
gathered by the Bureau of Labor Statistics, the Health
Resources and Services Administration, other entities within
the Department of Health and Human Services, the Department
of Veterans Affairs, the Centers for Medicare & Medicaid
Services, the Department of Defense, allied health
professional associations, and regional centers for health
workforce studies to determine educational pipeline and
practitioner shortages, and project future needs for such a
workforce.

``SEC. 799C-12. ALLIED HEALTH PROFESSIONS TRAINING FOR
DIVERSITY.

``The Secretary shall include schools of allied health
among the health professions schools that are eligible to
receive grants under this part for the purpose of assisting
such schools in supporting Centers of Excellence in health
professions education for under-represented minority
individuals.

``SEC. 799C-13. REPORTS BY GENERAL ACCOUNTING OFFICE.

``Not later than 4 years after the date of enactment of
this part, the Comptroller General of the United States shall
conduct an evaluation of whether the programs carried out
under this part have demonstrably increased the number of
applicants to allied health education programs and prepare
and submit to the appropriate committees of Congress a report
concerning the results of such evaluation.

``SEC. 799C-14. AUTHORIZATION OF APPROPRIATIONS.

``There is authorized to be appropriated to carry out this
part, such sums as may be necessary for each of fiscal years
2008 through 2013.''.
______

By Mr. DORGAN (for himself, Mr. Bayh, Mr. Bingaman, Mrs. Boxer,
Mr. Brown, Mrs. Clinton, Mr. Conrad, Mr. Durbin, Mr. Feingold,
Mrs. Feinstein, Mr. Harkin, Mr. Kennedy, Mr. Kerry, Ms.
Landrieu, Mr. Lautenberg, Mr. Leahy, Mr. Menendez, Ms.
Mikulski, Mr. Nelson of Florida, Mr. Obama, Mr. Pryor, Mr.
Reid, and Mr. Wyden):
S. 606. A bill to improve Federal contracting and procurement by
eliminating fraud and abuse and improving competition in contracting
and procurement and by enhancing administration of Federal contracting
personnel, and for other purposes; to the Committee on Homeland
Security and Governmental Affairs.
Mr. LEAHY. I am proud to cosponsor this bill, which will create new
and better tools to combat fraud, waste, and abuse in government
contracting. I commend our chief sponsor, Senator Byron Dorgan, for his
leadership on this.
Waste, fraud, and abuse in the name of defense is destructive and
offensive, and it should never be tolerated. It saps critical resources
needed by our troops, and it plays the taxpayers for fools, all the
while hiding under the cover of national defense.
Within the last few weeks, the Special Inspector General for Iraq
Reconstruction has reported that the problems of waste, fraud, and
abuse continue to plague our reconstruction efforts in Iraq, and
billions of dollars are unaccounted for, and possibly lost, to fraud
and waste. So far, the Inspector General has initiated more than 100
investigations into this fraud and abuse, but to date the Department of
Justice has prosecuted just a few individuals for wrongdoing. The
Department has yet to prosecute any of the contracting companies or
their senior officials for fraud.
This legislative reform package establishes new criminal penalties
for war profiteers and cheats who, for ill-gotten gain, would exploit
the chaos of war. I recently introduced the War Profiteering Prevention
Act of 2007, and I am pleased that Senator Dorgan has included this
legislation in the Honest Leadership and Accountability in Contracting
Act.
This legislation also promotes openness and fairness in contracting,
and it includes safeguards to end cronyism and eliminate conflicts of
interest in contracting decisions. It also strengthens the Federal
protections afforded to whistleblowers who alert the public to contract
fraud and misconduct.
We have introduced antiwar profiteering legislation in the past, but
the Republican-led Congress has repeatedly refused to pass it. While
Congress has waited to act, we have learned that private contractors
have stolen and defrauded, by some estimates, hundreds of millions of
dollars from money that should have supported our troops in Iraq and
Afghanistan. The time to stop these shameful acts is now, and Congress
should act swiftly to enact this vital legislation.
I will continue my efforts on this issue as chairman of the Judiciary
Committee. In particular, I plan to hold a hearing next month on the
war profiteering bill.
Every penny of our taxpayers' money must be protected from waste, and
Federal contracts--which are paid for with taxpayer funds--should be
open and transparent. This is an accountability bill, and taxpayers
deserve this to be one of our highest priorities.
______

By Mrs. FEINSTEIN (for herself, Mr. Cornyn, Mrs. Boxer, Mrs.
Hutchison, Mr. Lautenberg, Mr. Schumer, Mrs. Clinton, Mr.
Menendez, and Mr. Obama):
S. 608. A bill to improve the allocation of grants through the
Department of Homeland Security, and for other purposes; to the
Committee on Homeland Security and Governmental Affairs.
Mrs. FEINSTEIN. Mr. President, I rise today to introduce legislation
that ensures our Nation's homeland security grant resources are
allocated in the most effective manner possible. I am pleased to be
joined by my colleague from Texas, Senator John Cornyn, as well as
Senators Boxer, Hutchison, Lautenberg, Schumer, Clinton, Menendez, and
Obama.
Simply put, the current system for allocating homeland security
grants to States is fundamentally flawed. Proportionate funding is not
allotted to regions which face the highest risk of a terrorist attack,
and adequate assessment of threats is not calculated.
The ``Risk-Based Homeland Security Grants Act of 2007'' addresses
these

[[Page S2031]]

concerns with a common-sense approach that responsibly directs taxpayer
dollars to protect our Nation's vital interests.
The methodology is straightforward and spelled out in the language at
the beginning of the bill:

The Secretary of Homeland Security shall ensure that
homeland security grants are allocated based on an assessment
of threat, vulnerability, and consequence to the maximum
extent practicable.

This direction would apply to the four major first-responder grant
programs administered by the Department of Homeland Security: the State
Homeland Security Grant Program; the Urban Area Security Initiative;
the Law Enforcement Terrorism Prevention Program; and the Citizens
Corps Program.
The primary objective of the legislation is accomplished by reducing
the amount of funding that each State is guaranteed. Current practice
requires a ``small state minimum,'' giving each State at least 0.75
percent of much of the grant funding.
The result is that roughly 38 percent of the funds are marked for
distribution before any substantive risk analysis has been performed.
That sends disproportionate money to low-risk, rural areas and
territories.
For most, this outcome is not acceptable. Funding to bolster the
security of our country should go to where the threat is greatest--such
as seaports, airports, and national landmarks.
This bill lowers the ``small state minimum'' to 0.25 percent per
State. A Homeland Security Grants Board, comprised of seven top
Department of Homeland Security officials, including the Secretary of
Homeland Security and the Undersecretary of Information Analysis and
Infrastructure Protection, is established to rank grant applications
based upon risk. Three factors guide this evaluation: threat,
vulnerability, and consequence.
The current system, by contrast, allocates a significant amount of
funding to states based upon their population.
To ensure that grant funds are properly accounted for, and utilized
within an integrated framework to enhance domestic security, grants
must be designed to meet ``essential'' capabilities.
``Essential capabilities'' refers to the ability of regions to
address risks by reducing vulnerability to attacks and diminishing the
consequences of such attacks by effective response.
This legislation assures that States must demonstrate that they have
a detailed, prioritized plan for emergency preparedness and resource
allocation, so that Federal funds are assigned to the most effective
uses.
States must then quickly distribute the Federal funds to regions and
localities.
The notion of risk-based allocation of homeland security grants is
not novel. This is a bipartisan approach advocated by both the Bush
Administration and the 9/11 Commission.
The 9/11 Commission report said: ``Homeland security assistance
should be based strictly on an assessment of risks and
vulnerabilities.''
Four years ago, President Bush signed Homeland Security Presidential
Directive 8, which required the Department of Homeland Security to
allocate grant funding ``based on national priorities.''
In April 2005, Representatives Cox and Turner, the Chair and Ranking
Member of the House Homeland Security Committee at the time, offered
similar legislation to reform the grant process by reducing State
minimums and allocating funds based upon risk assessments.
That effort, the ``Faster and Smarter Funding for First Responders
Act of 2005,'' passed the House of Representatives as part of the
Intelligence Reform bill, but was dropped in conference. This bill is
based on the House efforts, and closely tracks the previous bill.
Again, the House has acted, passing legislation last month, by an
overwhelming vote of 299-128, to implement the recommendations of the
9/11 Committee. A key component is the risk-based allocation of
homeland security resources.
This bill, though updated to reflect recent changes at the Department
of Homeland Security, marks the continuation of a legislation effort we
began last session, with the FORWARD Funding Act. That bill was
unsuccessful. Hopefully, this time will be different.
In the post-Cold War world, America needs the flexibility to defend
against a different type of enemy. The amorphous nature of the threat
and likelihood of asymmetric attacks demands a robust approach.
But our resources are limited, and difficult choices must be made.
We will never know exactly how, when or where the next major attack
may occur. But we can refine our risk-assessment capabilities, and make
objective analyses and predictions. It follows that our resources
should be directed based upon our best estimate of where the next
strike might take place.
Two guiding principles--the ability to predict future attacks,
coupled with the necessity of utilizing finite resources effectively--
form the backbone of a comprehensive strategy to make our Nation more
secure.
The approach is three-pronged: risks of potential terrorist attacks
must be accurately assessed; the vulnerability of critical
infrastructure and potential targets must be measured; and, resources
should be dispersed based upon these assessments.
The Department of Homeland Security was created to accomplish these
goals. Yet we find again and again that scarce resources are allocated
based on factors unrelated to real security.
For example, last year California's Urban Area Security Initiative
grants totaled only $6.81 per capita. Hawaii received $11.55 per
capita, and Wyoming, $18.06 per capita.
I recognize the environment in which we are operating, and understand
this bill is not a panacea. This bill is a first step towards reducing
the threat of terrorist attacks.
Congress should not act alone. The Department of Homeland Security
must embrace the concept of risk-based allocation of resources. And it
must act on these principles. Slow progress has been made, but the
Department's intelligence analysis and vulnerability assessment
capabilities must be improved.
We can do better. We must put aside pork-barrel politics and take
action to protect all Americans. The security of our Nation hangs in
the balance and we cannot afford to wait until it is too late.
This bill was conceived and put forth in the spirit of
bipartisanship. I hope that Senators Lieberman and Collins will accept
this legislation, which is a reasoned alternative to their approach and
a starting point for continued discussion.
I ask my colleagues to join me in supporting this simple,
straightforward approach to effectively distribute our Nation's
resources and make America secure.
I ask unanimous consent that the text of the bill be printed in the
Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:

S. 608

Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title.--This Act may be cited as the ``Risk-Based
Homeland Security Grants Act of 2007''.
(b) Table of Contents.--The table of contents for this Act
is as follows:

Sec. 1. Short title; table of contents.
Sec. 2. Risk-based funding for homeland security.
Sec. 3. Essential capabilities, task forces, and standards.
Sec. 4. Effective administration of homeland security grants.
Sec. 5. Implementation and definitions.

SEC. 2. RISK-BASED FUNDING FOR HOMELAND SECURITY.

(a) Risk-Based Funding in General.--The Homeland Security
Act of 2002 (Public Law 107-296; 6 U.S.C. 361 et seq.) is
amended by adding at the end the following:

``TITLE XX--RISK-BASED FUNDING FOR HOMELAND SECURITY

``SEC. 2001. RISK-BASED FUNDING FOR HOMELAND SECURITY.

``(a) Risk-Based Funding.--The Secretary shall ensure that
homeland security grants are allocated based on an assessment
of threat, vulnerability, and consequence to the maximum
extent practicable.
``(b) Covered Grants.--This title applies to grants
provided by the Department to States, regions, or directly
eligible tribes for the primary purpose of improving the
ability of first responders to prevent, prepare for, respond
to, or mitigate threatened or actual terrorist attacks,
especially those involving weapons of mass destruction, and
grants provided by the Department for improving homeland
security, including the following:

[[Page S2032]]

``(1) State homeland security grant program.--The State
Homeland Security Grant Program of the Department, or any
successor to such grant program.
``(2) Urban area security initiative.--The Urban Area
Security Initiative of the Department, or any successor to
such grant program.
``(3) Law enforcement terrorism prevention program.--The
Law Enforcement Terrorism Prevention Program of the
Department, or any successor to such grant program.
``(4) Citizen corps program.--The Citizen Corps Program of
the Department, or any successor to such grant program.
``(c) Excluded Programs.--This title does not apply to or
otherwise affect the following Federal grant programs or any
grant under such a program:
``(1) Nondepartment programs.--Any Federal grant program
that is not administered by the Department.
``(2) Fire grant programs.--The fire grant programs
authorized by sections 33 and 34 of the Federal Fire
Prevention and Control Act of 1974 (15 U.S.C. 2229, 2229a).
``(3) Emergency management planning and assistance account
grants.--The Emergency Management Performance Grant program
and the Urban Search and Rescue Grants program authorized by
title VI of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act (42 U.S.C. 5195 et seq.), the
Departments of Veterans Affairs and Housing and Urban
Development, and Independent Agencies Appropriations Act,
2000 (113 Stat. 1047 et seq.), and the Earthquake Hazards
Reduction Act of 1977 (42 U.S.C. 7701 et seq.).
``(d) Effect on Covered Grants.--Nothing in this Act shall
be construed to require the elimination of a covered grant
program.''.
(b) Covered Grant Eligibility and Criteria.--The Homeland
Security Act of 2002 (Public Law 107-296; 6 U.S.C. 361 et
seq.), as amended by subsection (a), is amended by adding at
the end the following:

``SEC. 2002. COVERED GRANT ELIGIBILITY AND CRITERIA.

``(a) Grant Eligibility.--
``(1) In general.--
``(A) General eligibility.--Except as provided in
subparagraphs (B) and (C), any State, region, or directly
eligible tribe shall be eligible to apply for a covered
grant.
``(B) Urban area security initiative.--Only a region shall
be eligible to apply for a grant under the Urban Area
Security Initiative of the Department, or any successor to
such grant program.
``(C) State homeland security grant program.--Only a State
shall be eligible to apply for a grant under the State
Homeland Security Grant Program of the Department, or any
successor to such grant program.
``(2) Other grant applicants.--
``(A) In general.--Grants provided by the Department for
improving homeland security, including to seaports, airports,
and other transportation facilities, shall be allocated as
described in section 2001(a).
``(B) Consideration.--Such grants shall be considered, to
the extent determined appropriate by the Secretary, pursuant
to the procedures and criteria established in this title,
except that the eligibility requirements of paragraph (1)
shall not apply.
``(3) Certification of regions.--
``(A) In general.--The Secretary shall certify a geographic
area as a region if--
``(i) the geographic area meets the criteria under section
2007(10)(B) and (C); and
``(ii) the Secretary determines, based on an assessment of
threat, vulnerability, and consequence, that certifying the
geographic area as a region under this title is in the
interest of national homeland security.
``(B) Existing urban area security initiative areas.--
Notwithstanding subparagraphs (B) and (C) of section
2007(10), a geographic area that, on or before the date of
enactment of the Risk-Based Homeland Security Grants Act of
2007, was designated as a high-threat urban area for purposes
of the Urban Area Security Initiative, shall be certified by
the Secretary as a region unless the Secretary determines,
based on an assessment of threat, vulnerability, and
consequence, that certifying the geographic area as a region
is not in the interest of national homeland security.
``(b) Grant Criteria.--In awarding covered grants, the
Secretary shall assist States, local governments, and
operators of airports, ports, or similar facilities in
achieving, maintaining, and enhancing the essential
capabilities established by the Secretary under section 2003.
``(c) State Homeland Security Plans.--
``(1) Submission of plans.--The Secretary shall require
that any State applying to the Secretary for a covered grant
shall submit to the Secretary a 3-year State homeland
security plan that--
``(A) demonstrates the extent to which the State has
achieved the essential capabilities that apply to the State;
``(B) demonstrates the needs of the State necessary to
achieve, maintain, or enhance the essential capabilities that
apply to the State;
``(C) includes a prioritization of such needs based on
threat, vulnerability, and consequence assessment factors
applicable to the State;
``(D) describes how the State intends--
``(i) to address such needs at the city, county, regional,
tribal, State, and interstate level, including a precise
description of any regional structure the State has
established for the purpose of organizing homeland security
preparedness activities funded by covered grants;
``(ii) to use all Federal, State, and local resources
available for the purpose of addressing such needs; and
``(iii) to give particular emphasis to regional planning
and cooperation, including the activities of
multijurisdictional planning agencies governed by local
officials, both within its jurisdictional borders and with
neighboring States;
``(E) is developed in consultation with and subject to
appropriate comment by local governments within the State;
and
``(F) with respect to the emergency preparedness of first
responders, addresses the unique aspects of terrorism as part
of a comprehensive State emergency management plan.
``(2) Approval by secretary.--The Secretary may not award
any covered grant to a State unless the Secretary has
approved the applicable State homeland security plan.
``(d) Consistency With State Plans.--The Secretary shall
ensure that each covered grant is used to supplement and
support, in a consistent and coordinated manner, the
applicable State homeland security plan or plans.
``(e) Application for Grant.--
``(1) In general.--Except as otherwise provided in this
subsection, any State, region, directly eligible tribe, or
operator of an airport, port, or similar facility may apply
for a covered grant by submitting to the Secretary an
application at such time, in such manner, and containing such
information as is required under this subsection, or as the
Secretary may reasonably require.
``(2) Deadlines for applications and awards.--All
applications for covered grants shall be submitted at such
time as the Secretary may reasonably require for the fiscal
year for which they are submitted. The Secretary shall award
covered grants pursuant to all approved applications for such
fiscal year as soon as practicable, but not later than March
1 of such year.
``(3) Availability of funds.--All funds awarded by the
Secretary under covered grants in a fiscal year shall be
available for obligation through the end of the second
subsequent fiscal year.
``(4) Minimum contents of application.--The Secretary shall
require that each applicant include in its application, at a
minimum--
``(A) the purpose for which the applicant seeks covered
grant funds and the reasons why the applicant needs the
covered grant to meet the essential capabilities for
terrorism preparedness within the State, region, or directly
eligible tribe or at the airport, port, or similar facility
to which the application pertains;
``(B) a description of how, by reference to the applicable
State homeland security plan or plans under subsection (c),
the allocation of grant funding proposed in the application,
including, where applicable, the amount not passed through
under section 2006(g)(1), would assist in fulfilling the
essential capabilities specified in such plan or plans;
``(C) a statement of whether a mutual aid agreement applies
to the use of all or any portion of the covered grant funds;
``(D) if the applicant is a State, a description of how the
State plans to allocate the covered grant funds to regions,
local governments, and Indian tribes;
``(E) if the applicant is a region--
``(i) a precise geographical description of the region and
a specification of all participating and nonparticipating
local governments within the geographical area comprising
that region;
``(ii) a specification of what governmental entity within
the region will administer the expenditure of funds under the
covered grant;
``(iii) a designation of a specific individual to serve as
regional liaison; and
``(iv) a description of how the governmental entity
administering the expenditure of funds under the covered
grant plans to allocate the covered grant funds to States,
local governments, and Indian tribes;
``(F) a capital budget showing how the applicant intends to
allocate and expend the covered grant funds; and
``(G) if the applicant is a directly eligible tribe, a
designation of a specific individual to serve as the tribal
liaison.
``(5) Regional applications.--
``(A) Relationship to state applications.--A regional
application--
``(i) shall be coordinated with an application submitted by
the State or States of which such region is a part;
``(ii) shall supplement and avoid duplication with such
State application; and
``(iii) shall address the unique regional aspects of such
region's terrorism preparedness needs beyond those provided
for in the application of such State or States.
``(B) State review and submission.--To ensure the
consistency required under subsection (d) and the
coordination required under subparagraph (A) of this
paragraph, an applicant that is a region shall submit its
application to each State of which any part is included in
the region for review and concurrence before the submission
of such application to the Secretary. The regional
application shall be transmitted to the Secretary through
each such State within 30 days after receipt of the
application by that State, unless the Governor of such a
State notifies the Secretary, in writing, that such regional
application is inconsistent with the State's homeland
security plan and provides an explanation of the reasons
therefor.

[[Page S2033]]

``(C) Distribution of regional awards.--If the Secretary
approves a regional application, then the Secretary shall
distribute a regional award to the State or States submitting
the applicable regional application under subparagraph (B),
and each such State shall, not later than the end of the 45-
day period beginning on the date after receiving a regional
award, pass through to the region all covered grant funds or
resources purchased with such funds, except those funds
necessary for the State to carry out its responsibilities
with respect to such regional application; Provided That, in
no such case shall the State or States pass through to the
region less than 80 percent of the regional award.
``(D) Certifications regarding distribution of grant funds
to regions.--Any State that receives a regional award under
subparagraph (C) shall certify to the Secretary, by not later
than 30 days after the expiration of the period described in
subparagraph (C) with respect to the grant, that the State
has made available to the region the required funds and
resources in accordance with subparagraph (C).
``(E) Direct payments to regions.--If any State fails to
pass through a regional award to a region as required by
subparagraph (C) within 45 days after receiving such award
and does not request or receive an extension of such period
under section 2006(h)(2), the region may petition the
Secretary to receive directly the portion of the regional
award that is required to be passed through to such region
under subparagraph (C).
``(F) Regional liaisons.--A regional liaison designated
under paragraph (4)(E)(iii) shall--
``(i) coordinate with Federal, State, local, regional, and
private officials within the region concerning terrorism
preparedness;
``(ii) develop a process for receiving input from Federal,
State, local, regional, and private sector officials within
the region to assist in the development of the regional
application and to improve the region's access to covered
grants; and
``(iii) administer, in consultation with State, local,
regional, and private officials within the region, covered
grants awarded to the region.
``(6) Tribal applications.--
``(A) Submission to the state or states.--To ensure the
consistency required under subsection (d), an applicant that
is a directly eligible tribe shall submit its application to
each State within the boundaries of which any part of such
tribe is located for direct submission to the Department
along with the application of such State or States.
``(B) Opportunity for state comment.--Before awarding any
covered grant to a directly eligible tribe, the Secretary
shall provide an opportunity to each State within the
boundaries of which any part of such tribe is located to
comment to the Secretary on the consistency of the tribe's
application with the State's homeland security plan. Any such
comments shall be submitted to the Secretary concurrently
with the submission of the State and tribal applications.
``(C) Final authority.--The Secretary shall have final
authority to determine the consistency of any application of
a directly eligible tribe with the applicable State homeland
security plan or plans, and to approve any application of
such tribe. The Secretary shall notify each State within the
boundaries of which any part of such tribe is located of the
approval of an application by such tribe.
``(D) Tribal liaison.--A tribal liaison designated under
paragraph (4)(G) shall--
``(i) coordinate with Federal, State, and private sector
officials to assist in the development of the application of
such tribe and to improve the tribe's access to covered
grants; and
``(ii) administer, in consultation with State, local,
regional, and private officials, covered grants awarded to
such tribe.
``(E) Limitation on the number of direct grants.--The
Secretary may make covered grants directly to not more than
20 directly eligible tribes per fiscal year.
``(F) Tribes not receiving direct grants.--An Indian tribe
that does not receive a grant directly under this section is
eligible to receive funds under a covered grant from the
State or States within the boundaries of which any part of
such tribe is located, consistent with the homeland security
plan of the State as described in subsection (c). If a State
fails to comply with section 2006(g)(1), the tribe may
request payment under section 2006(h)(3) in the same manner
as a local government.
``(7) Equipment standards.--If an applicant for a covered
grant proposes to upgrade or purchase, with assistance
provided under the grant, new equipment or systems that do
not meet or exceed any applicable national voluntary
consensus standards established by the Secretary under
section 2005(a), the applicant shall include in the
application an explanation of why such equipment or systems
will serve the needs of the applicant better than equipment
or systems that meet or exceed such standards.
``(f) Homeland Security Grants Board.--
``(1) Establishment of board.--The Secretary shall
establish a Homeland Security Grants Board, consisting of--
``(A) the Secretary;
``(B) the Deputy Secretary of Homeland Security;
``(C) the Under Secretary for Emergency Preparedness and
Response;
``(D) the Under Secretary for Border and Transportation
Security;
``(E) the Under Secretary for Information Analysis and
Infrastructure Protection;
``(F) the Under Secretary for Science and Technology; and
``(G) the Director of the Office of State and Local
Government Coordination.
``(2) Chairman.--
``(A) In general.--The Secretary shall be the Chairman of
the Board.
``(B) Exercise of authorities by deputy secretary.--The
Deputy Secretary of Homeland Security may exercise the
authorities of the Chairman, if the Secretary so directs.
``(3) Risk-based ranking of grant applications.--
``(A) Prioritization of grants.--The Board--
``(i) shall evaluate and annually prioritize all pending
applications for covered grants based upon the degree to
which they would, by achieving, maintaining, or enhancing the
essential capabilities of the applicants on a nationwide
basis, lessen the threat to, vulnerability of, and
consequences for persons and critical infrastructure; and
``(ii) in evaluating the threat to persons and critical
infrastructure for purposes of prioritizing covered grants,
shall give greater weight to threats of terrorism based on
their specificity and credibility, including any pattern of
repetition.
``(B) Minimum amounts.--
``(i) In general.--After evaluating and prioritizing grant
applications under subparagraph (A), the Board shall ensure
that, for each fiscal year, each State that has an approved
State homeland security plan receives no less than 0.25
percent of the funds available for the State Homeland
Security Grant Program, as described in section 2001(b)(1),
for that fiscal year for purposes of implementing its
homeland security plan in accordance with the prioritization
of additional needs under subsection (c)(1)(C).
``(ii) Other entities.--Notwithstanding clause (i), the
Board shall ensure that, for each fiscal year, American
Samoa, the Commonwealth of the Northern Mariana Islands,
Guam, and the Virgin Islands each receive 0.08 percent of the
funds available for the State Homeland Security Grant
Program, as described in section 2001(b)(1), for that fiscal
year for purposes of implementing its homeland security plan
in accordance with the prioritization of additional needs
under subsection (c)(1)(C).
``(4) Functions of under secretaries.--The Under
Secretaries referred to in paragraph (1) shall seek to ensure
that the relevant expertise and input of the staff of their
directorates are available to and considered by the Board.''.

SEC. 3. ESSENTIAL CAPABILITIES, TASK FORCES, AND STANDARDS.

The Homeland Security Act of 2002 (Public Law 107-296; 6
U.S.C. 361 et seq.), as amended by section 2, is amended by
adding at the end the following:

``SEC. 2003. ESSENTIAL CAPABILITIES FOR HOMELAND SECURITY.

``(a) Establishment of Essential Capabilities.--
``(1) In general.--For purposes of covered grants, the
Secretary shall establish clearly defined essential
capabilities for State and local government preparedness for
terrorism, in consultation with--
``(A) the Task Force on Essential Capabilities established
under section 2004;
``(B) the Under Secretaries for Emergency Preparedness and
Response, Border and Transportation Security, Information
Analysis and Infrastructure Protection, and Science and
Technology, and the Director of the Office of State and Local
Government Coordination;
``(C) the Secretary of Health and Human Services;
``(D) other appropriate Federal agencies;
``(E) State and local first responder agencies and
officials; and
``(F) consensus-based standard making organizations
responsible for setting standards relevant to the first
responder community.
``(2) Deadlines.--The Secretary shall--
``(A) establish essential capabilities under paragraph (1)
within 30 days after receipt of the report under section
2004(b); and
``(B) regularly update such essential capabilities as
necessary, but not less than every 3 years.
``(3) Provision of essential capabilities.--The Secretary
shall ensure that a detailed description of the essential
capabilities established under paragraph (1) is provided
promptly to the States and to Congress. The States shall make
the essential capabilities available as necessary and
appropriate to local governments and operators of airports,
ports, and other similar facilities within their
jurisdictions.
``(b) Objectives.--The Secretary shall ensure that
essential capabilities established under subsection (a)(1)
meet the following objectives:
``(1) Specificity.--The determination of essential
capabilities specifically shall describe the training,
planning, personnel, and equipment that different types of
communities in the Nation should possess, or to which they
should have access, in order to meet the Department's goals
for terrorism preparedness based upon--
``(A) the most current risk assessment available by the
Directorate for Information Analysis and Infrastructure
Protection of the threats of terrorism against the United
States;
``(B) the types of threats, vulnerabilities, geography,
size, and other factors that the Secretary has determined to
be applicable to each different type of community; and

[[Page S2034]]

``(C) the principles of regional coordination and mutual
aid among State and local governments.
``(2) Flexibility.--The establishment of essential
capabilities shall be sufficiently flexible to allow State
and local government officials to set priorities based on
particular needs, while reaching nationally determined
terrorism preparedness levels within a specified time period.
``(3) Measurability.--The establishment of essential
capabilities shall be designed to enable measurement of
progress toward specific terrorism preparedness goals.
``(4) Comprehensiveness.--The determination of essential
capabilities for terrorism preparedness shall be made within
the context of a comprehensive State emergency management
system.
``(c) Factors To Be Considered.--
``(1) In general.--In establishing essential capabilities
under subsection (a)(1), the Secretary specifically shall
consider the variables of threat, vulnerability, and
consequences with respect to the Nation's population
(including transient commuting and tourist populations) and
critical infrastructure. Such consideration shall be based
upon the most current risk assessment available by the
Directorate for Information Analysis and Infrastructure
Protection of the threats of terrorism against the United
States.
``(2) Critical infrastructure sectors.--The Secretary
specifically shall consider threats of terrorism against the
following critical infrastructure sectors in all areas of the
Nation, urban and rural:
``(A) Agriculture.
``(B) Banking and finance.
``(C) Chemical industries.
``(D) The defense industrial base.
``(E) Emergency services.
``(F) Energy.
``(G) Food.
``(H) Government.
``(I) Postal and shipping.
``(J) Public health.
``(K) Information and telecommunications networks.
``(L) Transportation.
``(M) Water.
The order in which the critical infrastructure sectors are
listed in this paragraph shall not be construed as an order
of priority for consideration of the importance of such
sectors.
``(3) Types of threat.--The Secretary specifically shall
consider the following types of threat to the critical
infrastructure sectors described in paragraph (2), and to
populations in all areas of the Nation, urban and rural:
``(A) Biological threats.
``(B) Nuclear threats.
``(C) Radiological threats.
``(D) Incendiary threats.
``(E) Chemical threats.
``(F) Explosives.
``(G) Suicide bombers.
``(H) Cyber threats.
``(I) Any other threats based on proximity to specific past
acts of terrorism or the known activity of any terrorist
group.
The order in which the types of threat are listed in this
paragraph shall not be construed as an order of priority for
consideration of the importance of such threats.
``(4) Consideration of additional factors.--In establishing
essential capabilities under subsection (a)(1), the Secretary
shall take into account any other specific threat to a
population (including a transient commuting or tourist
population) or critical infrastructure sector that the
Secretary has determined to exist.

``SEC. 2004. TASK FORCE ON ESSENTIAL CAPABILITIES.

``(a) Establishment.--To assist the Secretary in
establishing essential capabilities under section 2003(a)(1),
the Secretary shall establish an advisory body pursuant to
section 871(a) not later than 60 days after the date of the
enactment of this section, which shall be known as the Task
Force on Essential Capabilities.
``(b) Report.--
``(1) In general.--The Task Force shall submit to the
Secretary, not later than 9 months after its establishment by
the Secretary under subsection (a) and every 3 years
thereafter, a report on its recommendations for essential
capabilities for preparedness for terrorism.
``(2) Contents.--The report shall--
``(A) include a priority ranking of essential capabilities
in order to provide guidance to the Secretary and to Congress
on determining the appropriate allocation of, and funding
levels for, first responder needs;
``(B) set forth a methodology by which any State or local
government will be able to determine the extent to which it
possesses or has access to the essential capabilities that
States and local governments having similar risks should
obtain;
``(C) describe the availability of national voluntary
consensus standards, and whether there is a need for new
national voluntary consensus standards, with respect to first
responder training and equipment;
``(D) include such additional matters as the Secretary may
specify in order to further the terrorism preparedness
capabilities of first responders; and
``(E) include such revisions to the contents of past
reports as are necessary to take into account changes in the
most current risk assessment available by the Directorate for
Information Analysis and Infrastructure Protection or other
relevant information as determined by the Secretary.
``(3) Consistency with federal working group.--The Task
Force shall ensure that its recommendations for essential
capabilities are, to the extent feasible, consistent with any
preparedness goals or recommendations of the Federal working
group established under section 319F(a) of the Public Health
Service Act (42 U.S.C. 247d-6(a)).
``(4) Comprehensiveness.--The Task Force shall ensure that
its recommendations regarding essential capabilities for
terrorism preparedness are made within the context of a
comprehensive State emergency management system.
``(5) Prior measures.--The Task Force shall ensure that its
recommendations regarding essential capabilities for
terrorism preparedness take into account any capabilities
that State or local officials have determined to be essential
and have undertaken since September 11, 2001, to prevent or
prepare for terrorist attacks.
``(c) Membership.--
``(1) In general.--The Task Force shall consist of 35
members appointed by the Secretary, and shall, to the extent
practicable, represent a geographic and substantive cross
section of governmental and nongovernmental first responder
disciplines from the State and local levels, including as
appropriate--
``(A) members selected from the emergency response field,
including fire service and law enforcement, hazardous
materials response, emergency medical services, and emergency
management personnel (including public works personnel
routinely engaged in emergency response);
``(B) health scientists, emergency and inpatient medical
providers, and public health professionals, including experts
in emergency health care response to chemical, biological,
radiological, and nuclear terrorism, and experts in providing
mental health care during emergency response operations;
``(C) experts from Federal, State, and local governments,
and the private sector, representing standards-setting
organizations, including representation from the voluntary
consensus codes and standards development community,
particularly those with expertise in first responder
disciplines; and
``(D) State and local officials with expertise in terrorism
preparedness, subject to the condition that if any such
official is an elected official representing 1 of the 2 major
political parties, an equal number of elected officials shall
be selected from each such party.
``(2) Coordination with the department of health and human
services.--In the selection of members of the Task Force who
are health professionals, including emergency medical
professionals, the Secretary shall coordinate the selection
with the Secretary of Health and Human Services.
``(3) Ex officio members.--The Secretary and the Secretary
of Health and Human Services shall each designate 1 or more
officers of their respective Departments to serve as ex
officio members of the Task Force. One of the ex officio
members from the Department of Homeland Security shall be the
designated officer of the Federal Government for purposes of
subsection (e) of section 10 of the Federal Advisory
Committee Act (5 App. U.S.C.).
``(d) Applicability of Federal Advisory Committee Act.--
Notwithstanding section 871(a), the Federal Advisory
Committee Act (5 U.S.C. App.), including subsections (a),
(b), and (d) of section 10 of such Act, and section 552b(c)
of title 5, United States Code, shall apply to the Task
Force.

``SEC. 2005. NATIONAL STANDARDS FOR FIRST RESPONDER EQUIPMENT
AND TRAINING.

``(a) Equipment Standards.--
``(1) In general.--The Secretary, in consultation with the
Under Secretaries for Emergency Preparedness and Response and
Science and Technology and the Director of the Office of
State and Local Government Coordination, shall, not later
than 6 months after the date of enactment of this section,
support the development of, promulgate, and update as
necessary national voluntary consensus standards for the
performance, use, and validation of first responder equipment
for purposes of section 2002(e)(7). Such standards--
``(A) shall be, to the maximum extent practicable,
consistent with any existing voluntary consensus standards;
``(B) shall take into account, as appropriate, new types of
terrorism threats that may not have been contemplated when
such existing standards were developed;
``(C) shall be focused on maximizing interoperability,
interchangeability, durability, flexibility, efficiency,
efficacy, portability, sustainability, and safety; and
``(D) shall cover all appropriate uses of the equipment.
``(2) Required categories.--In carrying out paragraph (1),
the Secretary shall specifically consider the following
categories of first responder equipment:
``(A) Thermal imaging equipment.
``(B) Radiation detection and analysis equipment.
``(C) Biological detection and analysis equipment.
``(D) Chemical detection and analysis equipment.
``(E) Decontamination and sterilization equipment.
``(F) Personal protective equipment, including garments,
boots, gloves, and hoods, and other protective clothing.

[[Page S2035]]

``(G) Respiratory protection equipment.
``(H) Interoperable communications, including wireless and
wireline voice, video, and data networks.
``(I) Explosive mitigation devices and explosive detection
and analysis equipment.
``(J) Containment vessels.
``(K) Contaminant-resistant vehicles.
``(L) Such other equipment for which the Secretary
determines that national voluntary consensus standards would
be appropriate.
``(b) Training Standards.--
``(1) In general.--The Secretary, in consultation with the
Under Secretaries for Emergency Preparedness and Response and
Science and Technology and the Director of the Office of
State and Local Government Coordination, shall support the
development of, promulgate, and regularly update as necessary
national voluntary consensus standards for first responder
training carried out with amounts provided under covered
grant programs, that will enable State and local government
first responders to achieve optimal levels of terrorism
preparedness as quickly as practicable. Such standards shall
give priority to providing training to--
``(A) enable first responders to prevent, prepare for,
respond to, and mitigate terrorist threats, including threats
from chemical, biological, nuclear, and radiological weapons
and explosive devices capable of inflicting significant human
casualties; and
``(B) familiarize first responders with the proper use of
equipment, including software, developed pursuant to the
standards established under subsection (a).
``(2) Required categories.--In carrying out paragraph (1),
the Secretary specifically shall include the following
categories of first responder activities:
``(A) Regional planning.
``(B) Joint exercises.
``(C) Intelligence collection, analysis, and sharing.
``(D) Emergency notification of affected populations.
``(E) Detection of biological, nuclear, radiological, and
chemical weapons of mass destruction.
``(F) Such other activities for which the Secretary
determines that national voluntary consensus training
standards would be appropriate.
``(3) Consistency.--In carrying out this subsection, the
Secretary shall ensure that such training standards are
consistent with the principles of emergency preparedness for
all hazards.
``(c) Consultation With Standards Organizations.--In
establishing national voluntary consensus standards for first
responder equipment and training under this section, the
Secretary shall consult with relevant public and private
sector groups, including--
``(1) the National Institute of Standards and Technology;
``(2) the National Fire Protection Association;
``(3) the National Association of County and City Health
Officials;
``(4) the Association of State and Territorial Health
Officials;
``(5) the American National Standards Institute;
``(6) the National Institute of Justice;
``(7) the Inter-Agency Board for Equipment Standardization
and Interoperability;
``(8) the National Public Health Performance Standards
Program;
``(9) the National Institute for Occupational Safety and
Health;
``(10) ASTM International;
``(11) the International Safety Equipment Association;
``(12) the Emergency Management Accreditation Program;
``(13) the National Domestic Preparedness Consortium; and
``(14) to the extent the Secretary considers appropriate,
other national voluntary consensus standards development
organizations, other interested Federal, State, and local
agencies, and other interested persons.
``(d) Coordination With Secretary of HHS.--In establishing
any national voluntary consensus standards under this section
for first responder equipment or training that involve or
relate to health professionals, including emergency medical
professionals, the Secretary shall coordinate activities
under this section with the Secretary of Health and Human
Services.''.

SEC. 4. EFFECTIVE ADMINISTRATION OF HOMELAND SECURITY GRANTS.

(a) Use of Grant Funds and Accountability.--The Homeland
Security Act of 2002 (Public Law 107-296; 6 U.S.C. 361 et
seq.), as amended by sections 2 and 3, is amended by adding
at the end the following:

``SEC. 2006. USE OF FUNDS AND ACCOUNTABILITY REQUIREMENTS.

``(a) In General.--A covered grant may be used for--
``(1) purchasing, upgrading, or maintaining equipment,
including computer software, to enhance terrorism
preparedness and response;
``(2) exercises to strengthen terrorism preparedness and
response;
``(3) training for prevention (including detection) of,
preparedness for, or response to attacks involving weapons of
mass destruction, including training in the use of equipment
and computer software;
``(4) developing or updating response plans;
``(5) establishing or enhancing mechanisms for sharing
terrorism threat information;
``(6) systems architecture and engineering, program
planning and management, strategy formulation and strategic
planning, life-cycle systems design, product and technology
evaluation, and prototype development for terrorism
preparedness and response purposes;
``(7) additional personnel costs resulting from--
``(A) elevations in the threat alert level of the Homeland
Security Advisory System by the Secretary, or a similar
elevation in threat alert level issued by a State, region, or
local government with the approval of the Secretary;
``(B) travel to and participation in exercises and training
in the use of equipment and on prevention activities;
``(C) the temporary replacement of personnel during any
period of travel to and participation in exercises and
training in the use of equipment and on prevention
activities; and
``(D) participation in information, investigative, and
intelligence-sharing activities specifically related to
terrorism prevention;
``(8) the costs of equipment (including software) required
to receive, transmit, handle, and store classified
information;
``(9) target hardening to reduce the vulnerability of high-
value targets, as determined by the Secretary;
``(10) protecting critical infrastructure against potential
attack by the addition of barriers, fences, gates, and other
such devices, except that the cost of such measures may not
exceed the greater of--
``(A) $1,000,000 per project; or
``(B) such greater amount as may be approved by the
Secretary, which may not exceed 10 percent of the total
amount of the covered grant;
``(11) the costs of commercially available interoperable
communications equipment (which, where applicable, is based
on national, voluntary consensus standards) that the
Secretary, in consultation with the Chairman of the Federal
Communications Commission, deems best suited to facilitate
interoperability, coordination, and integration between and
among emergency communications systems, and that complies
with prevailing grant guidance of the Department for
interoperable communications;
``(12) educational curricula development for first
responders to ensure that they are prepared for terrorist
attacks;
``(13) training and exercises to assist public elementary
and secondary schools in developing and implementing programs
to instruct students regarding age-appropriate skills to
prepare for and respond to an act of terrorism;
``(14) paying of administrative expenses directly related
to administration of the grant, except that such expenses may
not exceed 3 percent of the amount of the grant; and
``(15) other appropriate activities as determined by the
Secretary.
``(b) Prohibited Uses.--Funds provided as a covered grant
may not be used--
``(1) to supplant State or local funds that have been
obligated for a homeland security or other first responder-
related project;
``(2) to construct buildings or other physical facilities,
except for--
``(A) activities under section 611 of the Robert T.
Stafford Disaster Relief and Emergency Assistance Act (42
U.S.C. 5196); and
``(B) upgrading facilities to protect against, test for,
and treat the effects of biological agents, which shall be
included in the homeland security plan approved by the
Secretary under section 2002(c);
``(3) to acquire land; or
``(4) for any State or local government cost-sharing
contribution.
``(c) Multiple-Purpose Funds.--Nothing in this section
shall be construed to preclude State and local governments
from using covered grant funds in a manner that also enhances
first responder preparedness for emergencies and disasters
unrelated to acts of terrorism, if such use assists such
governments in achieving essential capabilities for terrorism
preparedness established by the Secretary under section 2003.
``(d) Reimbursement of Costs.--In addition to the
activities described in subsection (a), a covered grant may
be used to provide a reasonable stipend to paid-on-call or
volunteer first responders who are not otherwise compensated
for travel to or participation in training covered by this
section. Any such reimbursement shall not be considered
compensation for purposes of rendering such a first responder
an employee under the Fair Labor Standards Act of 1938 (29
U.S.C. 201 et seq.).
``(e) Assistance Requirement.--The Secretary may not
request that equipment paid for, wholly or in part, with
funds provided as a covered grant be made available for
responding to emergencies in surrounding States, regions, and
localities, unless the Secretary undertakes to pay the costs
directly attributable to transporting and operating such
equipment during such response.
``(f) Flexibility in Unspent Homeland Security Grant
Funds.--Upon request by the recipient of a covered grant, the
Secretary may authorize the grantee to transfer all or part
of funds provided as the covered grant from uses specified in
the grant agreement to other uses authorized under this
section, if the Secretary determines that such transfer is in
the interests of homeland security.
``(g) State, Regional, and Tribal Responsibilities.--
``(1) Pass-through.--The Secretary shall require a
recipient of a covered grant that is a State to obligate or
otherwise make available to local governments, first
responders,

[[Page S2036]]

and other local groups, to the extent required under the
State homeland security plan or plans specified in the
application for the grant, not less than 80 percent of the
grant funds, resources purchased with the grant funds having
a value equal to at least 80 percent of the amount of the
grant, or a combination thereof, by not later than the end of
the 45-day period beginning on the date the grant recipient
receives the grant funds.
``(2) Certifications regarding distribution of grant funds
to local governments.--Any State that receives a covered
grant shall certify to the Secretary, by not later than 30
days after the expiration of the period described in
paragraph (1) with respect to the grant, that the State has
made available for expenditure by local governments, first
responders, and other local groups the required amount of
grant funds pursuant to paragraph (1).
``(3) Quarterly report on homeland security spending.--Each
recipient of a covered grant shall submit a quarterly report
to the Secretary not later than 30 days after the end of each
fiscal quarter. Each such report shall include, for each
recipient of a covered grant or a pass-through under
paragraph (1)--
``(A) the amount obligated to that recipient in that
quarter;
``(B) the amount expended by that recipient in that
quarter; and
``(C) a summary description of the items purchased by such
recipient with such amount.
``(4) Annual report on homeland security spending.--Each
recipient of a covered grant shall submit an annual report to
the Secretary not later than 60 days after the end of each
fiscal year. Each recipient of a covered grant that is a
region shall simultaneously submit its report to each State
of which any part is included in the region. Each recipient
of a covered grant that is a directly eligible tribe shall
simultaneously submit its report to each State within the
boundaries of which any part of such tribe is located. Each
report shall include the following:
``(A) The amount, ultimate recipients, and dates of receipt
of all funds received under the grant during the previous
fiscal year.
``(B) The amount and the dates of disbursements of all such
funds expended in compliance with paragraph (1) or pursuant
to mutual aid agreements or other sharing arrangements that
apply within the State, region, or directly eligible tribe,
as applicable, during the previous fiscal year.
``(C) How the funds were utilized by each ultimate
recipient or beneficiary during the preceding fiscal year.
``(D) The extent to which essential capabilities identified
in the applicable State homeland security plan or plans were
achieved, maintained, or enhanced as the result of the
expenditure of grant funds during the preceding fiscal year.
``(E) The extent to which essential capabilities identified
in the applicable State homeland security plan or plans
remain unmet.
``(5) Inclusion of restricted annexes.--A recipient of a
covered grant may submit to the Secretary an annex to the
annual report under paragraph (4) that is subject to
appropriate handling restrictions, if the recipient believes
that discussion in the report of unmet needs would reveal
sensitive but unclassified information.
``(6) Provision of reports.--The Secretary shall ensure
that each annual report under paragraph (4) is provided to
the Under Secretary for Emergency Preparedness and Response
and the Director of the Office of State and Local Government
Coordination.
``(h) Incentives to Efficient Administration of Homeland
Security Grants.--
``(1) Penalties for delay in passing through local share.--
If a recipient of a covered grant that is a State fails to
pass through to local governments, first responders, and
other local groups funds or resources required by subsection
(g)(1) within 45 days after receiving funds under the grant,
the Secretary may--
``(A) reduce grant payments to the grant recipient from the
portion of grant funds that is not required to be passed
through under subsection (g)(1);
``(B) terminate payment of funds under the grant to the
recipient, and transfer the appropriate portion of those
funds directly to local first responders that were intended
to receive funding under that grant; or
``(C) impose additional restrictions or burdens on the
recipient's use of funds under the grant, which may include--
``(i) prohibiting use of such funds to pay the grant
recipient's grant-related overtime or other expenses;
``(ii) requiring the grant recipient to distribute to local
government beneficiaries all or a portion of grant funds that
are not required to be passed through under subsection
(g)(1); or
``(iii) for each day that the grant recipient fails to pass
through funds or resources in accordance with subsection
(g)(1), reducing grant payments to the grant recipient from
the portion of grant funds that is not required to be passed
through under subsection (g)(1), except that the total amount
of such reduction may not exceed 20 percent of the total
amount of the grant.
``(2) Extension of period.--The Governor of a State may
request in writing that the Secretary extend the 45-day
period under section 2002(e)(5)(E) or paragraph (1) for an
additional 15-day period. The Secretary may approve such a
request, and may extend such period for additional 15-day
periods, if the Secretary determines that the resulting delay
in providing grant funding to the local government entities
that will receive funding under the grant will not have a
significant detrimental impact on such entities' terrorism
preparedness efforts.
``(3) Provision of non-local share to local government.--
``(A) In general.--The Secretary may upon request by a
local government pay to the local government a portion of the
amount of a covered grant awarded to a State in which the
local government is located, if--
``(i) the local government will use the amount paid to
expedite planned enhancements to its terrorism preparedness
as described in any applicable State homeland security plan
or plans;
``(ii) the State has failed to pass through funds or
resources in accordance with subsection (g)(1); and
``(iii) the local government complies with subparagraph
(B).
``(B) Showing required.--To receive a payment under this
paragraph, a local government must demonstrate that--
``(i) it is identified explicitly as an ultimate recipient
or intended beneficiary in the approved grant application;
``(ii) it was intended by the grantee to receive a
severable portion of the overall grant for a specific purpose
that is identified in the grant application;
``(iii) it petitioned the grantee for the funds or
resources after expiration of the period within which the
funds or resources were required to be passed through under
subsection (g)(1); and
``(iv) it did not receive the portion of the overall grant
that was earmarked or designated for its use or benefit.
``(C) Effect of payment.--Payment of grant funds to a local
government under this paragraph--
``(i) shall not affect any payment to another local
government under this paragraph; and
``(ii) shall not prejudice consideration of a request for
payment under this paragraph that is submitted by another
local government.
``(D) Deadline for action by secretary.--The Secretary
shall approve or disapprove each request for payment under
this paragraph by not later than 15 days after the date the
request is received by the Department.
``(i) Reports to Congress.--The Secretary shall submit an
annual report to Congress by December 31 of each year--
``(1) describing in detail the amount of Federal funds
provided as covered grants that were directed to each State,
region, and directly eligible tribe in the preceding fiscal
year;
``(2) containing information on the use of such grant funds
by grantees; and
``(3) describing--
``(A) the Nation's progress in achieving, maintaining, and
enhancing the essential capabilities established under
section 2003(a) as a result of the expenditure of covered
grant funds during the preceding fiscal year; and
``(B) an estimate of the amount of expenditures required to
attain across the United States the essential capabilities
established under section 2003(a).''.
(b) Sense of Congress Regarding Interoperable
Communications.--
(1) Finding.--Congress finds that--
(A) many emergency response providers (as defined under
section 2 of the Homeland Security Act of 2002 (6 U.S.C.
101), as amended by this Act) working in the same
jurisdiction or in different jurisdictions cannot effectively
and efficiently communicate with one another; and
(B) their inability to do so threatens the public's safety
and may result in unnecessary loss of lives and property.
(2) Sense of congress.--It is the sense of Congress that
interoperable emergency communications systems and radios
should continue to be deployed as soon as practicable for use
by the emergency response provider community, and that
upgraded and new digital communications systems and new
digital radios should meet prevailing national voluntary
consensus standards for interoperability.
(c) Sense of Congress Regarding Citizen Corps Councils.--
(1) Finding.--Congress finds that Citizen Corps councils
help to enhance local citizen participation in terrorism
preparedness by coordinating multiple Citizen Corps programs,
developing community action plans, assessing possible
threats, and identifying local resources.
(2) Sense of congress.--It is the sense of Congress that
individual Citizen Corps councils should seek to enhance the
preparedness and response capabilities of all organizations
participating in the councils, including by providing funding
to as many of their participating organizations as
practicable to promote local terrorism preparedness programs.
(d) Required Coordination.--The Secretary of Homeland
Security shall ensure that there is effective and ongoing
coordination of Federal efforts to prevent, prepare for, and
respond to acts of terrorism and other major disasters and
emergencies among the divisions of the Department of Homeland
Security, including the Directorate of Emergency Preparedness
and Response and the Office for State and Local Government
Coordination and Preparedness.

[[Page S2037]]

(e) Coordination of Industry Efforts.--Section 102(f) of
the Homeland Security Act of 2002 (6 U.S.C. 112(f)) is
amended--
(1) in paragraph (9), by striking ``and'' after the
semicolon;
(2) in paragraph (10), by striking the period and inserting
``; and''; and
(3) by adding at the end the following:
``(11) coordinating industry efforts, with respect to
functions of the Department of Homeland Security, to identify
private sector resources and capabilities that could be
effective in supplementing Federal, State, and local
government agency efforts to prevent or respond to a
terrorist attack.''.
(f) Study Regarding Nationwide Emergency Notification
System.--
(1) Study.--The Secretary of Homeland Security, in
consultation with the heads of other appropriate Federal
agencies and representatives of providers and participants in
the telecommunications industry, shall conduct a study to
determine whether it is cost effective, efficient, and
feasible to establish and implement an emergency telephonic
alert notification system that will--
(A) alert persons in the United States of imminent or
current hazardous events caused by acts of terrorism; and
(B) provide information to individuals regarding
appropriate measures that may be undertaken to alleviate or
minimize threats to their safety and welfare posed by such
events.
(2) Technologies to consider.--In conducting the study
under paragraph (1), the Secretary shall consider the use of
the telephone, wireless communications, and other existing
communications networks to provide such notification.
(3) Report.--Not later than 9 months after the date of
enactment of this Act, the Secretary shall submit to Congress
a report regarding the conclusions of the study conducted
under paragraph (1).
(g) Study of Expansion of Area of Jurisdiction of Office of
National Capital Region Coordination.--
(1) Study.--The Secretary of Homeland Security, acting
through the Director of the Office of National Capital Region
Coordination, shall conduct a study of the feasibility and
desirability of modifying the definition of ``National
Capital Region'' applicable under section 882 of the Homeland
Security Act of 2002 (6 U.S.C. 462) to expand the geographic
area under the jurisdiction of the Office of National Capital
Region Coordination.
(2) Factors.--In conducting the study under paragraph (1),
the Secretary shall analyze whether expanding the geographic
area under the jurisdiction of the Office of National Region
Coordination will--
(A) promote coordination among State and local governments
within the Region, including regional governing bodies, and
coordination of the efforts of first responders; and
(B) enhance the ability of such State and local governments
and the Federal Government to prevent and respond to a
terrorist attack within the Region.
(3) Report.--Not later than 6 months after the date of the
enactment of this Act, the Secretary shall submit a report to
Congress on the study conducted under paragraph (1), and
shall include in the report such recommendations (including
recommendations for legislation to amend section 882 of the
Homeland Security Act of 2002 (6 U.S.C. 462)) as the
Secretary considers appropriate.
(h) Study of Risk Allocation for Port Security Grants.--
(1) Study.--The Secretary of Homeland Security shall
conduct a study of the factors to be used for the allocation
of funds based on risk for port security grants made under
section 70107 of title 46, United States Code.
(2) Factors.--In conducting the study, the Secretary shall
analyze the volume of international trade and economic
significance of each port.
(3) Report.--Not later than 90 days after the enactment of
the Act, the Secretary shall submit a report to Congress on
the study and shall include recommendations for using such
factors in allocating grant funds to ports.
(i) Study of Allocation of Assistance to Firefighter
Grants.--
(1) Study.--The Secretary of Homeland Security shall
conduct a study of the allocation of grant fund awards made
under the Assistance to Firefighter Grants program and shall
analyze the distribution of awards by State.
(2) Factors.--In conducting the study, the Secretary shall
analyze the number of awards and the per capita amount of
grant funds awarded to each State and the level of unmet
firefighting equipment needs in each State. The study shall
also analyze whether allowing local departments to submit
more than 1 annual application and expanding the list of
eligible applicants for such grants to include States will
enhance the ability of State and local governments to respond
to fires.
(3) Report.--Not later than 90 days after the date of
enactment of the Act, the Secretary shall submit a report to
Congress on the study and shall include recommendations for
legislation amending the factors used in allocating grant
funds to insure that critical firefighting needs are
addressed by the program in all areas of the Nation.

SEC. 5. IMPLEMENTATION; DEFINITIONS; TABLE OF CONTENTS.

(a) Technical and Conforming Amendment.--Section 1014 of
the USA PATRIOT ACT (42 U.S.C. 3714) is amended--
(1) by striking subsection (c)(3);
(2) by redesignating subsection (c) as subsection (d); and
(3) by inserting after subsection (b) the following:
``(c) Administration.--Grants under this section shall be
administered in accordance with title XX of the Homeland
Security Act of 2002.''.
(b) Temporary Limitations on Application.--
(1) 1-year delay in application.--The following provisions
of title XX of the Homeland Security Act of 2002, as added by
this Act, shall not apply during the 1-year period beginning
on the date of enactment of this Act--
(A) Subsections (b), (c), and (e)(4) (A) and (B) of section
2002; and
(B) In section 2002(f)(3)(A)(i), the phrase ``by achieving,
maintaining, or enhancing the essential capabilities of the
applicants on a nationwide basis,''.
(2) 2-year delay in application.--The following provisions
of title XX of the Homeland Security Act of 2002, as added by
this Act, shall not apply during the 2-year period beginning
on the date of enactment of this Act--
(A) Subparagraphs (D) and (E) of section 2006(g)(4); and
(B) Section 2006(i)(3).
(c) Definitions.--
(1) Title xx.--Title XX of the Homeland Security Act of
2002, as amended by sections 2, 3, and 4, is amended by
adding at the end the following:

``SEC. 2007. DEFINITIONS.

``In this title:
``(1) Board.--The term `Board' means the Homeland Security
Grants Board established under section 2002(f).
``(2) Consequence.--The term `consequence' means the
assessment of the effect of a completed attack.
``(3) Covered grant.--The term `covered grant' means any
grant to which this title applies under section 2001(b).
``(4) Directly eligible tribe.--The term `directly eligible
tribe' means any Indian tribe or consortium of Indian tribes
that--
``(A) meets the criteria for inclusion in the qualified
applicant pool for self-governance that are set forth in
section 402(c) of the Indian Self-Determination and Education
Assistance Act (25 U.S.C. 458bb(c));
``(B) employs at least 10 full-time personnel in a law
enforcement or emergency response agency with the capacity to
respond to calls for law enforcement or emergency services;
and
``(C)(i) is located on, or within 5 miles of, an
international border or waterway;
``(ii) is located within 5 miles of a facility designated
as high-risk critical infrastructure by the Secretary;
``(iii) is located within or contiguous to 1 of the 50
largest metropolitan statistical areas in the United States;
or
``(iv) has more than 1,000 square miles of Indian country,
as that term is defined in section 1151 of title 18, United
States Code.
``(5) Elevations in the threat alert level.--The term
`elevations in the threat alert level' means any designation
(including those that are less than national in scope) that
raises the homeland security threat level to either the
highest or second-highest threat level under the Homeland
Security Advisory System referred to in section 201(d)(7).
``(6) Emergency preparedness.--The term `emergency
preparedness' shall have the same meaning that term has under
section 602 of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act (42 U.S.C. 5195a).
``(7) Essential capabilities.--The term `essential
capabilities' means the levels, availability, and competence
of emergency personnel, planning, training, and equipment
across a variety of disciplines needed to effectively and
efficiently prevent, prepare for, and respond to acts of
terrorism consistent with established practices.
``(8) First responder.--The term `first responder' shall
have the same meaning as the term `emergency response
provider' under section 2.
``(9) Indian tribe.--The term `Indian tribe' means any
Indian tribe, band, nation, or other organized group or
community, including any Alaskan Native village or regional
or village corporation as defined in or established pursuant
to the Alaskan Native Claims Settlement Act (43 U.S.C. 1601
et seq.), which is recognized as eligible for the special
programs and services provided by the United States to
Indians because of their status as Indians.
``(10) Region.--The term `region' means any geographic
area--
``(A) certified by the Secretary under section 2002(a)(3);
``(B) consisting of all or parts of 2 or more counties,
municipalities, or other local governments and including a
city with a core population exceeding 500,000 according to
the most recent estimate available from the United States
Census; and
``(C) that, for purposes of an application for a covered
grant--
``(i) is represented by 1 or more local governments or
governmental agencies within such geographic area; and
``(ii) is established by law or by agreement of 2 or more
such local governments or governmental agencies, such as
through a mutual aid agreement.
``(11) Risk-based funding.--The term `risk-based funding'
means the allocation of funds based on an assessment of
threat, vulnerability, and consequence.

[[Page S2038]]

``(12) Task force.--The term `Task Force' means the Task
Force on Essential Capabilities established under section
2004.
``(13) Threat.--The term `threat' means the assessment of
the plans, intentions, and capability of an adversary to
implement an identified attack scenario.
``(14) Vulnerability.--The term `vulnerability' means the
degree to which a facility is available or accessible to an
attack, including the degree to which the facility is
inherently secure or has been hardened against such an
attack.''.
(2) Definition of emergency response providers.--Paragraph
(6) of section 2 of the Homeland Security Act of 2002 (6
U.S.C. 101(6)) is amended by striking ``includes'' and all
that follows and inserting ``includes Federal, State, and
local governmental and nongovernmental emergency public
safety, law enforcement, fire, emergency response, emergency
medical (including hospital emergency facilities), and
related personnel, organizations, agencies, and
authorities.''.
(d) Table of Contents.--Section 1(b) of the Homeland
Security Act of 2002 (6 U.S.C. 101 note) is amended in the
table of contents by adding at the end the following:

``TITLE XX--RISK-BASED FUNDING FOR HOMELAND SECURITY

``Sec. 2001. Risk-based funding for homeland security
``Sec. 2002. Covered grant eligibility and criteria
``Sec. 2003. Essential capabilities for homeland security
``Sec. 2004. Task Force on Essential Capabilities
``Sec. 2005. National standards for first responder equipment and
training
``Sec. 2006. Use of funds and accountability requirements
``Sec. 2007. Definitions''.

Mr. CORNYN. Mr. President, I rise today to join with my colleague,
Sen. Dianne Feinstein of California, and several of our distinguished
colleagues in introducing The Risk-Based Homeland Security Grants Act
of 2007.
Senator Feinstein, myself, and other Senators have been working now
for several years on changing how our homeland security dollars are
distributed throughout the country. Some have been talking about the
need for a risk-based allocation of assistance as long as the
Department of Homeland Security has been in existence. Throughout these
debates, Senator Feinstein has been a tireless advocate in this effort,
and I would like to thank her for her fine leadership and collaboration
in crafting this legislation.
The attacks on our country on September 11, 2001 were unprecedented
in our history, and they brought with them the need for similarly
unprecedented security measures. Our Nation needed to respond quickly
to the devastation that day delivered to our country, so the Federal
Government created a system that worked to raise overall national
emergency preparedness to ensure we could better guard against another
such terrorist attack.
And so, we embarked on the task of shoring up our airline,
transportation, border, and port security. We worked to protect our
critical infrastructure, to protect our cyber security, our agriculture
and food-supply systems.
But taxpayer dollars are not limitless, and Congress must work to
ensure every penny be directed where it will do the most good. It is
imperative that we guard the places across our Nation where terrorists
are most likely to strike, and where such strikes could do the most
damage to our people, our government, and our national economy. We
believe this is the most responsible way to prepare for any future
attack.
We need to have a system that will protect our most vulnerable assets
and populations--one that recognizes the need to protect the critical
infrastructure and vital components of our national economy. I am
reminded of this often when I travel around my home State of Texas.
Recently, I met with officials and business leaders from Houston and
Southeast Texas and discussed their homeland security needs. Their
needs are enormous considering the vast amount of critical
infrastructure and energy facilities in and among large population
centers. The potential consequences of a terrorist attack on any of
these facilities would be devastating, not only to the local
communities, but to the economic engine of the whole country.
Unfortunately, we got a small taste of effects of a disaster along
America's energy coast during the storms of 2005--hurricanes Katrina
and Rita.
The legislation that Senator Feinstein and I are proposing would
require that Federal Homeland Security funds be allocated to States
according to a risk-based assessment. It is vital that we better
allocate our limited resources to the vulnerable places in the country
we most need to protect, and that that these funds are distributed in
an efficient and timely manner.
Since we began this effort, I am pleased that there has been progress
made. The considerations of threat, vulnerability, and consequence have
been incorporated into more homeland security programs. But I'm
concerned that we haven't done enough. And I'm concerned that our
homeland security dollars are being treated as a pie in which all
States get to claim a piece, regardless of risk.
This approach is inconsistent if we truly evaluate the 9/11
Commission recommendations. They clearly call for allocation of money
based on an assessment of risks.
Our legislation provides for a distribution formula for homeland
security grants based on risk, which considers three main criteria:
threat, vulnerability, and consequence. It requires States to quickly
pass on Federal funds to areas where they are most needed. It provides
greater flexibility in using the funds, allowing a State to use them
for other hazards consistent with federally established capability
standards. And it allows States to retain authority to administer grant
programs, but there are penalties for states that do not pass funds to
local governments within 45 days, and if a State fails to pass the
funds through, local governments may petition the Department of
Homeland Security to receive the funds directly.
It is our hope and intent that, by introducing this bill, we can
positively contribute and enrich the public discourse on this critical
issue, and help move the Nation toward a more rational and effective
distribution of our homeland security resources.
Continuing to spread Homeland Security funds throughout the Nation--
irrespective of the actual risk to particular states and communities--
would be to ignore much of what we have learned as part of our effort
to assess our vulnerabilities since the attacks of September 11. So I
would urge that we swiftly work to pass this legislation, to better
ensure the safety of our citizens.
______

By Mr. ROCKEFELLER (for himself and Ms. Snowe):
S. 609. A bill to amend section 254 of the Communications Act of 1934
to provide that funds received as universal service contributions and
the universal service support programs established pursuant to that
section are not subject to certain provisions of title 31, United
States Code, commonly known as the Antideficiency Act; to the Committee
on Commerce, Science, and Transportation.
Mr. ROCKEFELLER. Mr. President, today I join with my colleagues,
Senator Olympia Snowe and Vice-Chairman Ted Stevens, to re-introduce
the Antideficiency Act to protect the Universal Service Program.
This is a bipartisan effort to ensure that all of the fundamental
universal service program can continue to operate smoothly and
effectively. Last year, this legislation garnered the support of 55
members, and I hope that it will gain additional support in the 110th
Congress. It is also important to note that the House also has a
similar bipartisan legislation.
For many years, I have fought hard for universal service, including
the E-Rate. It is essential for all of the universal service programs
to operate in a timely manner.
The Universal Service Fund is accomplishing its mission. Our country
has a strong telecommunications network, and rural customers are
getting service at affordable rates. Lifeline and Linkup programs help
the poorest of customers keep basic telephone access which is essential
in our modern world. Rural health care is helping connect our rural
clinics to modern medicine and specialists.
Over the past decade, the E-Rate discounts have helped to connect our
classrooms and our libraries to the Internet and modern technology. In
1996, when the Telecommunications Act passed, only 14 percent of
classrooms were connected, and just 5 percent of the poorest classrooms
were connected. The latest data is encouraging with 93 percent of all
classrooms connected and 89 percent of the poorest classrooms
connected. Since 1998, West Virginia schools and libraries have
received over $70 million in E-Rate discounts. While this is
extraordinary success, the need for E-Rate discounts remains because
schools and libraries

[[Page S2039]]

face monthly telecommunication costs and Internet access fees. Every
school and library will periodically need to upgrade its internal
connections.
This legislation gives the Universal Service Fund a permanent
exemption from the Antideficiency Act. Over the last few years, we have
done one year exemptions. It makes good sense to enact a long term
solution for the Universal Service Fund.
______

By Mr. ROCKEFELLER:
S. 610. A bill to clarify the effective date of the modification of
treatment for retirement annuity purposes of part-time service before
April 7, 1986, of certain Department of Veterans Affairs health-care
professionals; to the Committee on Veterans' Affairs.
Mr. ROCKEFELLER. Mr. President, today, I am introducing a bill to
change an unfair administrative decision that hurts aging, retired VA
nurses. This bill is designed to correct a problem from legislation
enacted in 2001, to help VA nurses' retirement. That legislation
improved nurses' pensions, and Congress intended it to be retroactive.
Unfortunately, administrative officials took a very narrow view of that
law. Currently VA nurses, who retired between 1986 and 2002, do not get
the full pension benefits as current retirees do.
In the 1980s, VA aggressively recruited nurses to fill a huge need at
VA medical centers by promising full retirement for part-time work. At
the time, nurses joined the VA, and they believed in the promise.
Sadly, the VA and the Office of Personnel Management (OPM) will not
fulfill that promise. This legislation would explicitly require the
Federal Government to honor its commitment to our retired VA nurses.
Pension benefits are a vital promise. It is disturbing when we do not
fulfill our obligations, and we simply must correct this error.
Nurses play a critical role in our health care system, including the
VA. Recruiting and retaining nurses is important, and this pension
shortfall does not help. It is time to deliver full pension benefits to
the retired nurses who cared for our veterans, but sadly retired in the
wrong years, between 1986 and 2002.
______

By Mr. LUGAR (for himself and Mr. Biden):
S. 613. A bill to enhance the overseas stabilization and
reconstruction capabilities of the United States Government, and for
other purposes; to the Committee on Foreign Relations.
Mr. LUGAR. Mr. President, this legislation authorizes the creation of
a civilian readiness corps to address post-conflict situations and
other emergencies overseas. The Senate already embraced the creation of
such a corps when it unanimously passed S. 3322 last June.
Unfortunately, that bill, introduced by Senator Biden and me and co-
sponsored by Senators Hagel, Alexander and Warner languished in the
House of Representatives. We have hopes that the 110th Congress will
now bring this idea to fruition.
In his State of the Union address last month, the President endorsed
the need for such a corps:
``A second task we can take on together is to design and establish a
volunteer Civilian Reserve Corps. Such a corps would function much like
our military reserve. It would ease the burden on the Armed Forces by
allowing us to hire civilians with critical skills to serve on missions
abroad when American needs them. It would give people across America
who do not wear the uniform a chance to serve in the defining struggle
of our time.'' President Bush, January 23, 2007, State of the Union
speech, Washington, DC.
The legislation I am introducing today is an updated version of S.
3322. It is the result of a conversation begun in 2003 between Members
of the Senate Foreign Relations Committee and the leadership of the
State Department. The concept has gone through a number of evolutions
and has passed the Committee unanimously both as a free-standing bill
and as part of the State Department authorization bill. I am asking the
Senate to pass it now again as a free-standing bill and send it to the
House with our unanimous approval.
International crises are inevitable, and in most cases, U.S. national
security interests will be threatened by sustained instability. The war
on terrorism necessitates that we not leave nations crumbling and
ungoverned. We have already seen how terrorists can exploit nations
afflicted by lawlessness and desperate circumstances. They seek out
such places to establish training camps, recruit new members, and tap
into a global black market in weapons.
In this international atmosphere, the United States must have the
right structures, personnel, and resources in place when an emergency
occurs. A delay in our response of a few weeks, or even days, can mean
the difference between success and failure. Clearly we need a full
range of tools to prevail. Our Committee's focus has been on boosting
the civilian side of our stabilization and reconstruction capabilities,
while encouraging improved mechanisms for civilian and military
agencies to work together on these missions.
Those who were once unconvinced of the need for such a corps have
only to look at our experience in Iraq and Afghanistan to understand
its value.
This legislation continues to build on the original legislation, S.
2127, that Senators Biden and Hagel and I introduced in early 2004 to
encourage and support a well-organized, sufficiently resourced and
strongly led civilian counterpart to the military in post-conflict
zones. It is our view that the civilian side needs both operational
capability and a significant surge capacity. This legislation gives
statutory status to the State Department's Office of the Coordinator of
Reconstruction and Stabilization and makes the position of Coordinator
subject to the advice and consent of the Senate. The legislation
authorizes the establishment of a federal response capability with both
active and standby components, as well as a civilian reserve that draws
upon the talent and willingness to serve that resides among our people.
It provides flexibility in personnel management, pay, and benefits to
build the corps and create surge capacity in an emergency. Finally, it
authorizes expenditures for a crisis response fund, for the civilian
response corps, and for a substantial training, planning and
operational capacity for the office.
The State Department has made progress through the Office of the
Coordinator of Reconstruction and Stabilization that was established in
July of 2004. The Office has already done a great deal of the
preliminary work needed to build an effective corps. But now it is time
for the Office to recruit, train, and organize the corps so that we
have deployable units.
We need to have a 250-person active duty component made up of State
Department and USAID employees. We need a 2,000 person standby
component drawn from both State and USAID, but also from other Federal
agencies that have employees who are willing to volunteer and have the
necessary skill sets. And we need to begin building a civilian reserve,
recruiting at least 500 highly skilled persons and eventually many
more.
The 250-person active duty personnel should include people with
skills that are more technical than the broader diplomatic
requirements--civil engineering, police expertise, agricultural
knowledge, health, education, and political organization. They should
have experience in difficult situations overseas and be trained and
available for rapid deployment with the military for both initial
assessments and programming purposes. They would be the first civilian
team on the ground in post-conflict situations, probably well in
advance of the establishment of an embassy.
Such a 250-person corps would be no larger than a typical army
company. But it would be a force multiplier. It would be equipped with
the authority and training to take broad operational responsibility for
stabilization missions. Establishment of such a corps is a modest
investment when seen as part of the overall national security budget.
Even in peace time, we maintain active duty military forces of almost
1.4 million men and women who train and plan for the possibility of
war. Given how critical post conflict situations have been to American
national security in the last decade, I believe it is reasonable to
have a mere 250 civilians who are training for these situations and are
capable of being deployed anywhere in the world, at any time they may
be needed.

[[Page S2040]]

Congress must now be willing to provide the funding to make this
corps a reality. This legislation authorizes a $75 million crisis
response fund to be made available as a contingency for stabilization
and reconstruction crises. Of this amount, the administration is
authorized to spend $25 million for the organization, training, and
emergency deployment of the response corps. This legislation authorizes
the crisis response fund and $80 million for the operations of the new
State Department office and the active duty component, including
training, equipment, and travel.
We have a long way to go in creating the kind of robust civilian
capacity that we need. Both the State Department and the Defense
Department are keenly aware of the importance of this legislation. If
we cannot plan better as a government, the United States may come to
depend even more on our military for tasks and functions far beyond its
current role. But I remain optimistic that we can build on the progress
already made to create a strong and reliable civilian component that
boosts our stabilization and reconstruction capabilities. Passing this
legislation once again will demonstrate that there is a keen
understanding in the Senate that we need to move forward. It will
support executive branch actions already taken and encourage further
progress. We hope that our friends in the House of Representatives,
several of whom are considering introducing their own legislation, will
move forward with the Senate in this endeavor. I urge adoption of this
legislation.
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. 613

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 ``Reconstruction and
Stabilization Civilian Management Act of 2007''.

SEC. 2. FINDING; PURPOSE.

(a) Finding.--Congress finds that the resources of the
United States Armed Forces have been burdened by having to
undertake stabilization and reconstruction tasks in the
Balkans, Afghanistan, Iraq, and other countries of the world
that could have been performed by civilians, which has
resulted in lengthy deployments for Armed Forces personnel.
(b) Purpose.--The purpose of this Act is to provide for the
continued development, as a core mission of the Department of
State and the United States Agency for International
Development, of an effective expert civilian response
capability to carry out reconstruction and stabilization
activities in a country or region that is at risk of, in, or
is in transition from, conflict or civil strife.

SEC. 3. DEFINITIONS.

In this Act:
(1) Administrator.--The term ``Administrator'' means the
Administrator of the United States Agency for International
Development.
(2) Appropriate congressional committees.--The term
``appropriate congressional committees'' means--
(A) the Committee on Foreign Relations of the Senate; and
(B) the Committee on Foreign Affairs of the House of
Representatives.
(3) Department.--Except as otherwise provided in this Act,
the term ``Department'' means the Department of State.
(4) Executive agency.--The term ``executive agency'' has
the meaning given that term in section 105 of title 5, United
States Code.
(5) Secretary.--The term ``Secretary'' means the Secretary
of State.

SEC. 4. SENSE OF CONGRESS.

It is the sense of Congress that--
(1) the civilian element of United States joint civilian-
military operations should be strengthened in order to
enhance the execution of current and future reconstruction
and stabilization activities in foreign countries or regions
that are at risk of, in, or are in transition from, conflict
or civil strife;
(2) the capability of civilian agencies of the United
States Government to carry out reconstruction and
stabilization activities in such countries or regions should
also be enhanced through a new rapid response corps of
civilian experts supported by the establishment of a new
system of planning, organization, personnel policies, and
education and training, and the provision of adequate
resources;
(3) the international community, including nongovernmental
organizations, and the United Nations and its specialized
agencies, should be further encouraged to participate in
planning and organizing reconstruction and stabilization
activities in such countries or regions;
(4) the executive branch has taken a number of steps to
strengthen civilian capability, including the establishment
of an office headed by a Coordinator for Reconstruction and
Stabilization in the Department, the Presidential designation
of the Secretary as the interagency coordinator and leader of
reconstruction and stabilization efforts, and Department of
Defense directives to the military to support the Office of
Reconstruction and Stabilization and to work closely with
counterparts in the Department of State and other civilian
agencies to develop and enhance personnel, training,
planning, and analysis;
(5) the Secretary and the Administrator should work with
the Secretary of Defense to augment existing personnel
exchange programs among the Department, the United States
Agency for International Development, and the Department of
Defense, including the regional commands and the Joint Staff,
to enhance the stabilization and reconstruction skills of
military and civilian personnel and their ability to
undertake joint operations; and
(6) the heads of other executive agencies should establish
personnel exchange programs that are designed to enhance the
stabilization and reconstruction skills of military and
civilian personnel.

SEC. 5. AUTHORITY TO PROVIDE ASSISTANCE FOR RECONSTRUCTION
AND STABILIZATION CRISES.

Chapter 1 of part III of the Foreign Assistance Act of 1961
(22 U.S.C. 2351 et seq.) is amended by inserting after
section 617 the following new section:

``SEC. 618. ASSISTANCE FOR A RECONSTRUCTION AND STABILIZATION
CRISIS.

``(a) Assistance.--
``(1) In general.--If the President determines that it is
important to the national interests of the United States for
United States civilian agencies or non-Federal employees to
assist in stabilizing and reconstructing a country or region
that is at risk of, in, or is in transition from, conflict or
civil strife, the President may, in accordance with the
provisions set forth in section 614(a)(3), notwithstanding
any other provision of law, and on such terms and conditions
as the President may determine, furnish assistance to respond
to the crisis using funds referred to in paragraph (2).
``(2) Funds.--The funds referred to in this paragraph are
funds as follows:
``(A) Funds made available under this section, including
funds authorized to be appropriated by subsection (d).
``(B) Funds made available under other provisions of this
Act and transferred or reprogrammed for purposes of this
section.
``(b) Special Authorities.--In furtherance of a
determination made under subsection (a), the President may
exercise the authorities contained in sections 552(c)(2) and
610 without regard to the percentage and aggregate dollar
limitations contained in such sections.
``(c) Availability of Funds for Response Readiness Corps.--
Of the funds made available for this section in any fiscal
year, including funds authorized to be appropriated by
subsection (d) and funds made available under other
provisions of this Act and transferred or reprogrammed for
purposes of this section, $25,000,000 may be made available
for expenses related to the development, training, and
operations of the Response Readiness Corps established under
section 61(c) of the State Department Basic Authorities Act
of 1956.
``(d) Authorization of Appropriations.--
``(1) Authorization.--There is authorized to be
appropriated $75,000,000 to provide assistance authorized in
subsection (a) and, to the extent authorized in subsection
(c), for the purpose described in subsection (c). Such amount
is in addition to amounts otherwise made available for
purposes of this section, including funds made available
under other provisions of this Act and transferred or
reprogrammed for purposes of this section.
``(2) Replenishment.--There is authorized to be
appropriated each fiscal year such sums as may be necessary
to replenish funds expended under this section.
``(3) Availability.--Funds authorized to be appropriated
under this subsection shall be available without fiscal year
limitation.''.

SEC. 6. OFFICE OF THE COORDINATOR FOR RECONSTRUCTION AND
STABILIZATION.

Title I of the State Department Basic Authorities Act of
1956 (22 U.S.C. 2651 et seq.) is amended by adding at the end
the following new section:

``SEC. 61. RECONSTRUCTION AND STABILIZATION.

``(a) Office of the Coordinator for Reconstruction and
Stabilization.--
``(1) Establishment.--There is established within the
Department of State the Office of the Coordinator for
Reconstruction and Stabilization.
``(2) Coordinator for reconstruction and stabilization.--
The head of the Office shall be the Coordinator for
Reconstruction and Stabilization, who shall be appointed by
the President, by and with the advice and consent of the
Senate. The Coordinator shall report directly to the
Secretary and shall have the rank and status of Ambassador at
Large.
``(3) Functions.--The functions of the Office of the
Coordinator for Reconstruction and Stabilization include the
following:
``(A) Monitoring, in coordination with relevant bureaus
within the Department of State, political and economic
instability

[[Page S2041]]

worldwide to anticipate the need for mobilizing United States
and international assistance for the stabilization and
reconstruction of countries or regions that are at risk of,
in, or are in transition from, conflict or civil strife.
``(B) Assessing the various types of stabilization and
reconstruction crises that could occur and cataloging and
monitoring the non-military resources and capabilities of
Executive agencies that are available to address such crises.
``(C) Planning to address requirements, such as
demobilization, policing, human rights monitoring, and public
information, that commonly arise in stabilization and
reconstruction crises.
``(D) Coordinating with relevant Executive agencies (as
that term is defined in section 105 of title 5, United States
Code) to develop interagency contingency plans to mobilize
and deploy civilian personnel to address the various types of
such crises.
``(E) Entering into appropriate arrangements with other
Executive agencies to carry out activities under this section
and the Reconstruction and Stabilization Civilian Management
Act of 2007.
``(F) Identifying personnel in State and local governments
and in the private sector who are available to participate in
the Response Readiness Corps established under subsection (c)
or to otherwise participate in or contribute to stabilization
and reconstruction activities.
``(G) Taking steps to ensure that training of civilian
personnel to perform such stabilization and reconstruction
activities is adequate and, as appropriate, includes security
training that involves exercises and simulations with the
Armed Forces, including the regional commands.
``(H) Sharing information and coordinating plans for
stabilization and reconstruction activities, as appropriate,
with the United Nations and its specialized agencies, the
North Atlantic Treaty Organization, nongovernmental
organizations, and other foreign national and international
organizations.
``(I) Coordinating plans and procedures for joint civilian-
military operations with respect to stabilization and
reconstruction activities.
``(J) Maintaining the capacity to field on short notice an
evaluation team to undertake on-site needs assessment.
``(b) Response to Stabilization and Reconstruction
Crisis.--If the President makes a determination regarding a
stabilization and reconstruction crisis under section 618 of
the Foreign Assistance Act of 1961, the President may
designate the Coordinator, or such other individual as the
President may determine appropriate, as the Coordinator of
the United States response. The individual so designated, or,
in the event the President does not make such a designation,
the Coordinator for Reconstruction and Stabilization, shall--
``(1) assess the immediate and long-term need for resources
and civilian personnel;
``(2) identify and mobilize non-military resources to
respond to the crisis; and
``(3) coordinate the activities of the other individuals or
management team, if any, designated by the President to
manage the United States response.''.

SEC. 7. RESPONSE READINESS CORPS.

(a) In General.--Section 61 of the State Department Basic
Authorities Act of 1956 (as added by section 6) is amended by
adding at the end the following new subsection:
``(c) Response Readiness Corps.--
``(1) In general.--The Secretary, in consultation with the
Administrator of the United States Agency for International
Development and the heads of other appropriate departments
and agencies of the United States Government, is authorized
to establish and maintain a Response Readiness Corps
(hereafter referred to in this subsection as the `Corps') to
provide assistance in support of stabilization and
reconstruction activities in foreign countries or regions
that are at risk of, in, or are in transition from, conflict
or civil strife.
``(2) Federal components.--
``(A) Active and standby components.--The Corps shall have
active and standby components consisting of United States
Government personnel as follows:
``(i) An active component, consisting of not more than 250
personnel who are recruited, employed, and trained in
accordance with this paragraph.
``(ii) A standby component, consisting of not more than
2000 personnel who are recruited and trained in accordance
with this paragraph.
``(B) Authorized members of standby component.--Personnel
in the standby component of the Corps may include employees
of the Department of State (including Foreign Service
Nationals), employees of the United States Agency for
International Development, employees of any other executive
agency (as that term is defined in section 105 of title 5,
United States Code), and employees of the legislative branch
and judicial branch of Government--
``(i) who are assigned to the standby component by the
Secretary following nomination for such assignment by the
head of the department or agency of the United States
Government concerned or by an appropriate official of the
legislative or judicial branch of Government, as applicable;
and
``(ii) who--

``(I) have the training and skills necessary to contribute
to stabilization and reconstruction activities; and
``(II) have volunteered for deployment to carry out
stabilization and reconstruction activities.

``(C) Recruitment and employment.--The recruitment and
employment of personnel to the Corps shall be carried out by
the Secretary, the Administrator of the United States Agency
for International Development, and the heads of the other
departments and agencies of the United States Government
participating in the establishment and maintenance of the
Corps.
``(D) Training.--The Secretary is authorized to train the
members of the Corps under this paragraph to perform services
necessary to carry out the purpose of the Corps under
paragraph (1).
``(E) Compensation.--Members of the active component of the
Corps under subparagraph (A)(i) shall be compensated in
accordance with the appropriate salary class for the Foreign
Service, as set forth in sections 402 and 403 of the Foreign
Service Act of 1980 (22 U.S.C. 3962, 3963), or in accordance
with the relevant authority under sections 3101 and 3392 of
title 5, United States Code.
``(3) Civilian reserve.--
``(A) Civilian reserve.--The Corps shall have a reserve
(hereafter referred to in this subsection as the `Civilian
Reserve') of non-United States Government personnel who are
trained and available as needed to perform services necessary
to carry out the purpose of the Corps under paragraph (1).
The Civilian Reserve shall be established by the Secretary,
in consultation with the Administrator of the Unites States
Agency for International Development and the heads of other
appropriate departments and agencies of the United States
Government.
``(B) Composition.--Beginning not later than one year after
the date of the enactment of the Reconstruction and
Stabilization Civilian Management Act of 2007, the Civilian
Reserve shall include at least 500 personnel, who may include
retired employees of the United States Government, contractor
personnel, nongovernmental organization personnel, State and
local government employees, and individuals from the private
sector, who--
``(i) have the training and skills necessary to enable them
to contribute to stabilization and reconstruction activities;
``(ii) have volunteered to carry out stabilization and
reconstruction activities; and
``(iii) are available for training and deployment to carry
out the purpose of the Corps under paragraph (1).
``(4) Use of response readiness corps.--
``(A) Federal active component.--Members of the active
component of the Corps under paragraph (2)(A)(i) are
authorized to be available--
``(i) for activities in direct support of stabilization and
reconstruction activities; and
``(ii) if not engaged in activities described in clause
(i), for assignment in the United States, United States
diplomatic missions, and United States Agency for
International Development missions.
``(B) Federal standby component and civilian reserve.--The
Secretary may deploy members of the Federal standby component
of the Corps under paragraph (2)(A)(ii), and members of the
Civilian Reserve under paragraph (3), in support of
stabilization and reconstruction activities in a foreign
country or region if the President makes a determination
regarding a stabilization and reconstruction crisis under
section 618 of the Foreign Assistance Act of 1961.''.
(b) Employment Authority.--The full-time personnel in the
active component of the Response Readiness Corps under
section 61(c)(2)(A)(i) of the State Department Basic
Authorities Act of 1956 (as added by subsection (a)) are in
addition to any other full-time personnel of the Department
or the United States Agency for International Development
authorized to be employed under any other provision of law.
(c) Report.--Not later than 180 days after the date of the
enactment of this Act, the Secretary shall submit to the
appropriate congressional committees a report on the status
of efforts to establish the Response Readiness Corps under
this section. The report should include recommendations for
any legislation necessary to implement section 61(c) of the
State Department Basic Authorities Act of 1956 (as so added).

SEC. 8. STABILIZATION AND RECONSTRUCTION TRAINING AND
EDUCATION.

Section 701 of the Foreign Service Act of 1980 (22 U.S.C.
4021) is amended--
(1) by redesignating subsection (g) as subsection (h); and
(2) by inserting after subsection (f) the following new
subsection:
``(g) Stabilization and Reconstruction Curriculum.--
``(1) Establishment and mission.--The Secretary, in
cooperation with the Secretary of Defense and the Secretary
of the Army, is authorized to establish a stabilization and
reconstruction curriculum for use in programs of the Foreign
Service Institute, the National Defense University, and the
United States Army War College.
``(2) Curriculum content.--The curriculum should include
the following:
``(A) An overview of the global security environment,
including an assessment of transnational threats and an
analysis of United States policy options to address such
threats.
``(B) A review of lessons learned from previous United
States and international experiences in stabilization and
reconstruction activities.

[[Page S2042]]

``(C) An overview of the relevant responsibilities,
capabilities, and limitations of various Executive agencies
(as that term is defined in section 105 of title 5, United
States Code) and the interactions among them.
``(D) A discussion of the international resources available
to address stabilization and reconstruction requirements,
including resources of the United Nations and its specialized
agencies, nongovernmental organizations, private and
voluntary organizations, and foreign governments, together
with an examination of the successes and failures experienced
by the United States in working with such entities.
``(E) A study of the United States interagency system.
``(F) Foreign language training.
``(G) Training and simulation exercises for joint civilian-
military emergency response operations.''.

SEC. 9. SERVICE RELATED TO STABILIZATION AND RECONSTRUCTION.

(a) Promotion Purposes.--Service in stabilization and
reconstruction operations overseas, membership in the
Response Readiness Corps under section 61(c) of the State
Department Basic Authorities Act of 1956 (as added by section
7), and education and training in the stabilization and
reconstruction curriculum established under section 701(g) of
the Foreign Service Act of 1980 (as added by section 8)
should be considered among the favorable factors for the
promotion of employees of Executive agencies.
(b) Personnel Training and Promotion.--The Secretary and
the Administrator should take steps to ensure that, not later
than 3 years after the date of the enactment of this Act, at
least 10 percent of the employees of the Department and the
United States Agency for International Development in the
United States are members of the Response Readiness Corps or
are trained in the activities of, or identified for potential
deployment in support of, the Response Readiness Corps. The
Secretary should provide such training as needed to
Ambassadors and Deputy Chiefs of Mission.
(c) Other Incentives and Benefits.--The Secretary and the
Administrator may establish and administer a system of awards
and other incentives and benefits to confer appropriate
recognition on and reward any individual who is assigned,
detailed, or deployed to carry out stabilization or
reconstruction activities in accordance with this Act.

SEC. 10. AUTHORITIES RELATED TO PERSONNEL.

(a) Contracting Authority.--
(1) In general.--The Secretary, or the Administrator with
the concurrence of the Secretary, may enter into contracts to
procure the services of nationals of the United States (as
defined in section 101(a)(22) of the Immigration and
Nationality Act (8 U.S.C. 1101(a)(22)) or aliens authorized
to be employed in the United States as personal services
contractors for the purpose of carrying out this Act, without
regard to Civil Service or classification laws, for service
in the Office of the Coordinator for Reconstruction and
Stabilization or for service in foreign countries to assist
in stabilizing and reconstructing a country or region that is
at risk of, in, or is in transition from, conflict or civil
strife.
(2) Not employees.--Individuals performing services under
contracts described in paragraph (1) shall not by virtue of
performing such services be considered to be employees of the
United States Government for purposes of any law administered
by the Office of Personnel Management (except that the
Secretary or Administrator may determine the applicability to
such individuals of any law administered by the Secretary or
Administrator concerning the performance of such services by
such individuals).
(b) Experts and Consultants.--The Secretary and the
Administrator may, to the extent necessary to obtain services
without delay, employ experts and consultants under section
3109 of title 5, United States Code, for the purpose of
carrying out this Act, without requiring compliance with any
otherwise applicable requirements for that employment as the
Secretary or Administrator may determine, except that such
employment shall be terminated after 60 days if by that time
the applicable requirements are not complied with.
(c) Authority To Accept and Assign Details.--The Secretary
is authorized to accept details or assignments of employees
of Executive agencies, members of the uniformed services, and
employees of State or local governments on a reimbursable or
nonreimbursable basis for the purpose of carrying out this
Act. The assignment of an employee of a State or local
government under this subsection shall be consistent with
subchapter VI of chapter 33 of title 5, United States Code.
(d) Dual Compensation Waiver.--
(1) Annuitants under civil service retirement system or
federal employees retirement system.--Notwithstanding
sections 8344(i) and 8468(f) of title 5, United States Code,
the Secretary or the head of another executive agency, as
authorized by the Secretary, may waive the application of
subsections (a) through (h) of such section 8344 and
subsections (a) through (e) of such section 8468 with respect
to annuitants under the Civil Service Retirement System or
the Federal Employees Retirement System who are assigned,
detailed, or deployed to assist in stabilizing and
reconstructing a country or region that is at risk of, in, or
is in transition from, conflict or civil strife during the
period of their reemployment.
(2) Annuitants under foreign service retirement and
disability system or foreign service pension system.--The
Secretary may waive the application of subsections (a)
through (d) of section 824 of the Foreign Service Act (22
U.S.C. 4064) for annuitants under the Foreign Service
Retirement and Disability System or the Foreign Service
Pension System who are reemployed on a temporary basis in
order to be assigned, detailed, or deployed to assist in
stabilization and reconstruction activities under this Act.
(e) Increase in Premium Pay Cap.--The Secretary, or the
head of another executive agency as authorized by the
Secretary, may compensate an employee detailed, assigned, or
deployed to assist in stabilizing and reconstructing a
country or region that is at risk of, in, or is in transition
from, conflict or civil strife, without regard to the
limitations on premium pay set forth in section 5547 of title
5, United States Code, to the extent that the aggregate of
the basic pay and premium pay of such employee for a year
does not exceed the annual rate payable for level II of the
Executive Schedule.
(f) Extension of Certain Foreign Service Benefits.--The
Secretary, or the head of another executive agency as
authorized by the Secretary, may extend to any individuals
assigned, detailed, or deployed to carry out stabilization
and reconstruction activities in accordance with this Act,
the benefits or privileges set forth in sections 412, 413,
704, and 901 of the Foreign Service Act of 1980 (22 U.S.C.
972, 22 U.S.C. 3973, 22 U.S.C. 4024, and 22 U.S.C. 4081) to
the same extent and manner that such benefits and privileges
are extended to members of the Foreign Service.
(g) Compensatory Time.--Notwithstanding any other provision
of law, the Secretary may, subject to the consent of an
individual who is assigned, detailed, or deployed to carry
out stabilization and reconstruction activities in accordance
with this Act, grant such individual compensatory time off
for an equal amount of time spent in regularly or irregularly
scheduled overtime work. Credit for compensatory time off
earned shall not form the basis for any additional
compensation. Any such compensatory time not used within 26
pay periods shall be forfeited.
(h) Acceptance of Volunteer Services.--
(1) In general.--The Secretary may accept volunteer
services for the purpose of carrying out this Act without
regard to section 1342 of title 31, United States Code.
(2) Types of volunteers.--Donors of voluntary services
accepted for purposes of this section may include--
(A) advisors;
(B) experts;
(C) consultants; and
(D) persons performing services in any other capacity
determined appropriate by the Secretary.
(3) Supervision.--The Secretary shall--
(A) ensure that each person performing voluntary services
accepted under this section is notified of the scope of the
voluntary services accepted;
(B) supervise the volunteer to the same extent as employees
receiving compensation for similar services; and
(C) ensure that the volunteer has appropriate credentials
or is otherwise qualified to perform in each capacity for
which the volunteer's services are accepted.
(4) Applicability of law relating to federal government
employees.--A person providing volunteer services accepted
under this section shall not be considered an employee of the
Federal Government in the performance of those services,
except for the purposes of the following provisions of law:
(A) Chapter 81 of title 5, United States Code, relating to
compensation for work-related injuries.
(B) Chapter 11 of title 18, United States Code, relating to
conflicts of interest.
(5) Applicability of law relating to volunteer liability
protection.--
(A) In general.--A person providing volunteer services
accepted under this section shall be deemed to be a volunteer
of a nonprofit organization or governmental entity, with
respect to the accepted services, for purposes of the
Volunteer Protection Act of 1997 (42 U.S.C. 14501 et seq.).
(B) Inapplicability of exceptions to volunteer liability
protection.--Section 4(d) of such Act (42 U.S.C. 14503(d))
does not apply with respect to the liability of a person with
respect to services of such person that are accepted under
this section.
(i) Authority for Outside Advisors.--
(1) In general.--The Secretary may establish temporary
advisory commissions composed of individuals with appropriate
expertise to facilitate the carrying out of this Act.
(2) Inapplicability of faca.--The requirements of the
Federal Advisory Committee Act (5 U.S.C. App.) shall not
apply to the activities of a commission established under
this subsection.

SEC. 11. AUTHORIZATION OF APPROPRIATIONS.

There is authorized to be appropriated for each fiscal
year, $80,000,000 for personnel, education and training,
equipment, and travel costs for purposes of carrying out this
Act and the amendments made by this Act (other than the
amendment made by section 5).
______

By Mr. LAUTENBERG (for himself, Mr. Brownback, Mr. Menendez, Mr.
Reid, Mrs. Clinton, Mr. Kennedy, Mr. Dodd, Mr. Lieberman, Mr.
Feingold, and Mr. Coleman):

[[Page S2043]]

S. 615. A bill to provide the nonimmigrant spouses and children of
nonimmigrant aliens who perished in the September 11, 2001, terrorist
attacks an opportunity to adjust their status to that of an alien
lawfully admitted for permanent residence, and for other purposes; to
the Committee on the Judiciary.
Mr. LAUTENBERG. Mr. President, I ask unanimous consent that the full
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. 615

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 ``September 11 Family
Humanitarian Relief and Patriotism Act''.

SEC. 2. ADJUSTMENT OF STATUS FOR CERTAIN NONIMMIGRANT VICTIMS
OF TERRORISM.

(a) Adjustment of Status.--
(1) In general.--The status of any alien described in
subsection (b) shall be adjusted by the Secretary of Homeland
Security to that of an alien lawfully admitted for permanent
residence, if the alien--
(A) applies for such adjustment not later than 2 years
after the date on which the Secretary promulgates final
regulations to implement this section; and
(B) is otherwise admissible to the United States for
permanent residence, except in determining such admissibility
the grounds for inadmissibility specified in paragraphs (4),
(5), (6)(A), (7)(A), and (9)(B) of section 212(a) of the
Immigration and Nationality Act (8 U.S.C. 1182(a)) shall not
apply.
(2) Rules in applying certain provisions.--
(A) In general.--In the case of an alien described in
subsection (b) who is applying for adjustment of status under
this section--
(i) the provisions of section 241(a)(5) of the Immigration
and Nationality Act (8 U.S.C. 1231(a)(5)) shall not apply;
and
(ii) the Secretary of Homeland Security may grant the alien
a waiver on the grounds of inadmissibility under
subparagraphs (A) and (C) of section 212(a)(9) of such Act (8
U.S.C. 1182(a)(9)).
(B) Standards.--In granting waivers under subparagraph
(A)(ii), the Secretary shall use standards used in granting
consent under subparagraphs (A)(iii) and (C)(ii) of such
section 212(a)(9).
(3) Relationship of application to certain orders.--
(A) Application permitted.--An alien present in the United
States who has been ordered excluded, deported, removed, or
ordered to depart voluntarily from the United States under
any provision of the Immigration and Nationality Act (8
U.S.C. 1101 et seq.) may, notwithstanding such order, apply
for adjustment of status under paragraph (1).
(B) Motion not required.--An alien described in
subparagraph (A) may not be required, as a condition of
submitting or granting such application, to file a separate
motion to reopen, reconsider, or vacate such order.
(C) Effect of decision.--If the Secretary of Homeland
Security grants a request under subparagraph (A), the
Secretary shall cancel the order. If the Secretary renders a
final administrative decision to deny the request, the order
shall be effective and enforceable to the same extent as if
the application had not been made.
(b) Aliens Eligible for Adjustment of Status.--The benefits
provided by subsection (a) shall apply to any alien who--
(1) was lawfully present in the United States as a
nonimmigrant alien described in section 101(a)(15) of the
Immigration and Nationality Act (8 U.S.C. 1101(a)(15)) on
September 10, 2001;
(2) was, on such date, the spouse, child, dependent son, or
dependent daughter of an alien who--
(A) was lawfully present in the United States as a
nonimmigrant alien described in section 101(a)(15) of the
Immigration and Nationality Act (8 U.S.C. 1101(a)(15)) on
such date; and
(B) died as a direct result of a specified terrorist
activity; and
(3) was deemed to be a beneficiary of, and by, the
September 11th Victim Compensation Fund of 2001 (49 U.S.C.
40101 note).
(c) Stay of Removal; Work Authorization.--
(1) In general.--The Secretary of Homeland Security shall
establish, by regulation, a process by which an alien subject
to a final order of removal may seek a stay of such order
based on the filing of an application under subsection (a).
(2) During certain proceedings.--Notwithstanding any
provision of the Immigration and Nationality Act (8 U.S.C.
1101 et seq.), the Secretary of Homeland Security shall not
order any alien to be removed from the United States, if the
alien is in removal proceedings under any provision of such
Act and has applied for adjustment of status under subsection
(a), except where the Secretary has rendered a final
administrative determination to deny the application.
(3) Work authorization.--The Secretary of Homeland Security
shall authorize an alien who has applied for adjustment of
status under subsection (a) to engage in employment in the
United States during the pendency of such application.
(d) Availability of Administrative Review.--The Secretary
of Homeland Security shall provide to applicants for
adjustment of status under subsection (a) the same right to,
and procedures for, administrative review as are provided
to--
(1) applicants for adjustment of status under section 245
of the Immigration and Nationality Act (8 U.S.C. 1255); or
(2) aliens subject to removal proceedings under section 240
of such Act (8 U.S.C. 1229a).

SEC. 3. CANCELLATION OF REMOVAL FOR CERTAIN IMMIGRANT VICTIMS
OF TERRORISM.

(a) In General.--Subject to the provisions of the
Immigration and Nationality Act (8 U.S.C. 1101 et seq.),
other than subsections (b)(1), (d)(1), and (e) of section
240A of such Act (8 U.S.C. 1229b), the Secretary of Homeland
Security shall, under such section 240A, cancel the removal
of, and adjust to the status of an alien lawfully admitted
for permanent residence, an alien described in subsection
(b), if the alien applies for such relief.
(b) Aliens Eligible for Cancellation of Removal.--The
benefits provided by subsection (a) shall apply to any alien
who--
(1) was, on September 10, 2001, the spouse, child,
dependent son, or dependent daughter of an alien who died as
a direct result of a specified terrorist activity; and
(2) was deemed to be a beneficiary of, and by, the
September 11th Victim Compensation Fund of 2001 (49 U.S.C.
40101 note).
(c) Stay of Removal; Work Authorization.--
(1) In general.--The Secretary of Homeland Security shall
provide by regulation for an alien subject to a final order
of removal to seek a stay of such order based on the filing
of an application under subsection (a).
(2) Work authorization.--The Secretary of Homeland Security
shall authorize an alien who has applied for cancellation of
removal under subsection (a) to engage in employment in the
United States during the pendency of such application.
(d) Motions to Reopen Removal Proceedings.--
(1) In general.--Notwithstanding any limitation imposed by
law on motions to reopen removal proceedings (except
limitations premised on an alien's conviction of an
aggravated felony (as defined in section 101(a)(43) of the
Immigration and Nationality Act (8 U.S.C. 1101(a)(43))), any
alien who has become eligible for cancellation of removal as
a result of the enactment of this section may file 1 motion
to reopen removal proceedings to apply for such relief.
(2) Filing period.--The Secretary of Homeland Security
shall designate a specific time period in which all such
motions to reopen are required to be filed. The period shall
begin not later than 60 days after the date of enactment of
this Act and shall extend for a period not to exceed 240
days.

SEC. 4. EXCEPTIONS.

Notwithstanding any other provision of this Act, an alien
may not be provided relief under this Act if the alien is--
(1) inadmissible under paragraph (2) or (3) of section
212(a) of the Immigration and Nationality Act (8 U.S.C.
1182(a)), or deportable under paragraph (2) or (4) of section
237(a) of such Act (8 U.S.C. 1227(a)), including any
individual culpable for a specified terrorist activity; or
(2) a family member of an alien described in paragraph (1).

SEC. 5. EVIDENCE OF DEATH.

For purposes of this Act, the Secretary of Homeland
Security shall use the standards established under section
426 of the Uniting and Strengthening America by Providing
Appropriate Tools Required to Intercept and Obstruct
Terrorism (USA PATRIOT ACT) Act of 2001 (115 Stat. 362) in
determining whether death occurred as a direct result of a
specified terrorist activity.

SEC. 6. DEFINITIONS.

(a) Application of Immigration and Nationality Act
Provisions.--Except as otherwise specifically provided in
this Act, the definitions used in the Immigration and
Nationality Act (8 U.S.C. 1101 et seq.), other than the
definitions applicable exclusively to title III of such Act,
shall apply in the administration of this Act.
(b) Specified Terrorist Activity.--For purposes of this
Act, the term ``specified terrorist activity'' means any
terrorist activity conducted against the Government or the
people of the United States on September 11, 2001.
______

By Ms. COLLINS (for herself and Mr. Feingold):
S. 616. A bill to promote health care coverage parity for individuals
participating in legal recreational activities or legal transportation
activities; to the Committee on Health, Education, Labor, and Pensions.
Ms. COLLINS. Mr. President, I am pleased to join with my colleague
from Wisconsin, Senator Feingold, in introducing legislation to
prohibit health insurers from denying benefits to plan participants if
they are injured while engaging in legal recreational activities like
skiing, snowmobiling, or horseback riding.
Among the many rules that were issued at the end of the Clinton
administration was one that was intended to

[[Page S2044]]

ensure non-discrimination in health coverage in the group market. This
rule was issued jointly on January 8, 2001, by the Department of Labor,
the Internal Revenue Service and the Health Care Financing
Administration--now the Centers for Medicare and Medicaid Services--in
accordance with the Health Insurance Portability and Accountability
Act, HIPAA, of 1996.
While I was pleased that the rule prohibits health plans and issuers
from denying coverage to individuals who engage in certain types of
recreational activities, such as skiing, horseback riding, snowmobiling
or motorcycling, I am concerned that it would allow insurers to deny
health benefits for an otherwise covered injury that results from
participation in these activities.
The rule states that ``While a person cannot be excluded from a plan
for engaging in certain recreational activities, benefits for a
particular injury can, in some cases, be excluded based on the source
of the injury.'' A plan could, for example, include a general exclusion
for injuries sustained while doing a specified list of recreational
activities, even though treatment for those injuries--a broken arm, for
instance--would have been covered under the plan if the individual had
tripped and fallen.
Because of this loophole, an individual who was injured while skiing
or running could be denied health care coverage, while someone who is
injured while drinking and driving a car would be protected.

This clearly is contrary to Congressional intent. One of the purposes
of HIPAA was to prohibit plans and issuers from establishing
eligibility rules for health coverage based on certain health-related
factors, including evidence of insurability. To underscore that point,
the conference report language stated that ``the inclusion of evidence
of insurability in the definition of health status is intended to
ensure, among other things, that individuals are not excluded from
health care coverage due to their participation in activities such as
motorcycling, snowmobiling, all-terrain vehicle riding, horseback
riding, skiing and other similar activities.'' The conference report
also states that ``this provision is meant to prohibit insurers or
employers from excluding employees in a group from coverage or charging
them higher premiums based on their health status and other related
factors that could lead to higher health costs.''
Mr. PRESIDENT, millions of Americans participate in these legal and
common recreational activities which, if practiced with appropriate
precautions, do not significantly increase the likelihood of serious
injury. Moreover, in enacting HIPAA, Congress simply did not intend
that people would be allowed to purchase health insurance only to find
out, after the fact, that they have no coverage for an injury resulting
from a common recreational activity. If this rule is allowed to stand,
millions of Americans will be forced to forgo recreational activities
that they currently enjoy lest they have an accident and find out that
they are not covered for needed care resulting from that accident.
The legislation that we are introducing today will clarify that
individuals participating in activities routinely enjoyed by millions
of Americans cannot be denied access to health care coverage or health
benefits as a result of their activities. The bill should not be
controversial. In fact, it passed the Senate by unanimous consent at
the end of the 108th Congress.
I am therefore hopeful that we will be able to move quickly on this
legislation this year, and I urge all of my colleagues to join us as
cosponsors.
______

By Mr. SMITH:
S. 617. A bill to make the National Parks and Federal Recreational
Lands Pass available at a discount to certain veterans; to the
Committee on Energy and Natural Resources.
Mr. SMITH. Mr. President, I rise today to introduce the Veterans
Eagle Parks Pass Act. This legislation would provide admission to any
Federal park that charges an admissions fee by creating a ``Veterans
Eagle Pass'' for honorably discharged veterans. I am pleased to
continue the efforts of my colleague Congressman Thomas Reynolds, who
performed yeoman's work to introduce and push forward this legislation
in the House of Representatives.
Currently, an annual America the Beautiful lands pass is available to
anyone for eighty dollars. My legislation would allow honorably
discharged veterans to buy an annual pass for only ten dollars. I feel
very strongly that those who fought so hard to protect our great nation
should have better and easier access to its public lands. It is only
fitting to offer our veterans improved entrance to America's great
public lands like Yosemite National Park in California, Fort Sumter
National Monument in South Carolina, Arthur R. Marshall Loxahatchee
National Wildlife Refuge in Florida, and Crater Lake National Park in
my home State of Oregon.
America's terrain is diverse, from flat plains to high mountains,
raging rivers to still lakes. Our country is truly bountiful. Many
veterans are avid outdoorsmen and understand the value and quality of
our land. In a time of such turmoil abroad, I see no more appropriate
opportunity to reward our veterans for their commitment and service to
our nation.
I am pleased that this legislation has received the support of the
American Legion, AMVETS, and Veterans of Foreign Wars. We owe it to our
veterans to provide them with this service.
______

By Mr. LEAHY (for himself, Mr. Specter, Mr. Lott, Mr. Reid, and
Ms. Landrieu):
S. 618. A bill to further competition in the insurance industry; to
the Committee on the Judiciary.
Mr. LEAHY. Mr. President, so people understand. I know the Senator
from Pennsylvania has spoken briefly about this and had remarks on it
printed in the Record.
Our Nation's competition laws are powerful tools to ensure that
consumer welfare is the benchmark of fair and accountable industry
practices. These competition laws are what make businesses work in
America. The vast majority of the companies doing business in the
United States are subject to our antitrust laws. Consumers benefit from
lower prices, more choices, better services.
There are only a few industries that operate outside the Federal
antitrust laws. The bipartisan measure I have introduced would end the
insurance industry's exemption from the requirement of those laws. I am
joined in this effort, as I said before, by the ranking member of the
Senate Judiciary Committee. Senator Specter has a strong record of
supporting effective competition in every industry through our
antitrust laws. Of course, as I have also said, I am joined by the
majority leader and by Senator Lott, who is the deputy Republican
leader.
Senator Lott probably wishes he was not in this position, but he
represents many of the gulf coast residents who can speak personally
and painfully to the abuses that insurers can wreak on their
policyholders. The insurance industry's practices affect us all.
Perhaps nowhere has the industry and its practices come under as much
scrutiny as along the gulf coast in the wake of hurricanes Katrina and
Rita. Insurers have been too often denying claims and delaying payments
to residents along the gulf coast instead of honoring their contractual
commitments. The behavior of insurers in Mississippi has been so
outrageous that the State's attorney general recently convened a grand
jury to investigate some of the practices.
It seems to me, insurance companies are very eager to collect
premiums when times are good but reluctant to compensate policyholders
when tragedy strikes. Senator Lott knows all too well the difficulties
his constituents have had with insurers. His State was hit hard by
Hurricane Katrina. I commend the Senator from Mississippi for his
tireless efforts in trying to ensure resources are in place to rebuild.
I know he is joined in that effort by his colleague from Mississippi,
Senator Cochran.
I have worked with others to support efforts to rebuild the Gulf
Coast. Most recently, I was pleased to assist Senator Landrieu in her
successful efforts to convince the Attorney General to dispatch
additional law enforcement to the New Orleans region. People in the
gulf coast are Americans. They are our fellow citizens. They have been
utterly failed by a woefully unprepared Government, and they should not
also be bullied and neglected by insurance companies in their time of
need.

The insurance industry has operated largely beyond the reach of
Federal

[[Page S2045]]

antitrust laws for more than six decades. Assuming there ever was a
justification to exempt insurers from Federal Government oversight, I
find it hard to believe there is still a reason to exempt them--not in
the age of instant communication, the age of the Internet, or the
ability to compare not only risks but payments. In fact, we need real
oversight, which can be brought about by removing them from the
antitrust exemption. We deserve confidence that the industry is not
engaging in the most egregious forms of anticompetitive conduct, such
as price-fixing, agreements not to pay, or market allocation.
Antitrust laws are the beacon of good competition policy. Insurers
may object to being subject to the same antitrust laws as everyone
else, but why shouldn't they be subject to the same laws as every other
company in this country? If they are operating in an honest and
appropriate and open way, they have nothing to fear.
I have more on this, but I ask unanimous consent that my full
statement be placed in the Record.
There being no objection, the material was ordered to be printed in
the Record as follows:

Mr. LEAHY. Mr. President, to reiterate, our Nation's
competition laws are powerful tools to ensure that consumer
welfare is the benchmark for fair and accountable industry
practices. The vast majority of the companies doing business
in the United States are subject to the strictures of the
antitrust laws, and consumers benefit through lower prices,
more choices, and better services. Only a few industries
operate outside the federal antitrust laws, and I am pleased
to introduce today a bipartisan measure that will end the
insurance industry's exemption from the requirements of those
laws.
I am joined in this effort by the ranking member of the
Senate Judiciary Committee who has a strong record of
supporting effective competition in every industry through
our antitrust laws. I am joined as well by Senator Reid and
Senator Lott. Senator Lott represents many of the gulf coast
residents who can speak personally, and painfully, to the
abuses that insurers can wreak on their policy holders.
Insurance industry practices affect all of us. They affect
each of our constituents; they affect every business in every
state. But perhaps nowhere has the industry and its practices
come under as much scrutiny as along the gulf coast in the
wake of Hurricanes Katrina and Rita. Insurers have been too
often denying claims and delaying payouts to residents along
the gulf coast instead of honoring their contractual
commitments to their customers, and thereby contributing to
the rebuilding and rejuvenation of the area.
The behavior of insurers in Mississippi has been so
outrageous that the state's attorney general recently
convened a grand jury to investigate certain practices.
Hundreds of policyholders had to go to court to force the
insurance companies to fulfill their obligations.
It seems some insurance companies are eager to collect
premiums when times are good, but reluctant to aid
policyholders when tragedy strikes.
Senator Lott knows all too well the difficulties his
constituents have had with insurers. His state was hit hard
by Hurricane Katrina, and I commend him on his tireless
efforts to ensure that resources are in place to rebuild. I
have worked with them in other contexts to support efforts to
rebuild the gulf coast. Most recently, I was honored to have
assisted Senator Landrieu in her successful efforts to
convince the attorney general to dispatch additional law
enforcement to the New Orleans region.
Our fellow citizens on the gulf coast who have had to cope
with the devastation and destruction of the 2005 hurricanes,
and who were utterly failed by their woefully unprepared
government, should not also be bullied or neglected by
insurance companies in their time of need--insurance
companies whose business is based on compensating people
after a tragic loss.
Unfortunately, the insurance industry has operated largely
beyond the reach of federal antitrust laws for more than six
decades. If there ever was, there is no longer any
justification to exempt the insurance industry from federal
government oversight.
Such oversight could provide confidence that the industry
is not engaging in the most egregious forms of
anticompetitive conduct--price fixing, agreements not to pay,
and market allocations.
The Insurance Industry Competition Act we introduce today
will simply give the Department of Justice and the Federal
Trade Commission the authority to apply the antitrust laws to
anticompetitive behavior by insurance companies. Our
antitrust laws are the beacon of good competition policy.
Competition is good for consumers and good for our economy.
Insurers may object to being subject to the same antitrust
laws as everyone else, but if they are operating in an honest
and appropriate way, they should have nothing to fear.
American consumers and American businesses rely on
insurance--it is a vital part of our economy--and they have
the right to be confident that the cost of their insurance,
and the decisions by their insurance carriers about which
claims will be paid, reflect competitive market conditions,
not collusive behavior.
I thank Senator Reid and Senator Specter for joining me in
this important effort. And I thank Senator Lott for his
support, and for using the lessons of his constituents'
experiences to shed light on an industry that for too long,
in too many ways, has been out of the reach of federal
antitrust authorities.

Mr. LEAHY. Mr. President, I see the Senator from Mississippi on the
floor and the Senator from Pennsylvania. If they are seeking time, I
would ask how much time they need.
Mr. LOTT. Mr. President, I wish to withhold until the Senator from
Pennsylvania makes his brief remarks.
Mr. LEAHY. How much time does the Senator from Pennsylvania want?
Because this is coming out of time I had set aside for something else.
Mr. SPECTER. Less than 5 minutes.
Mr. LEAHY. I yield 5 minutes to the Senator from Pennsylvania.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. SPECTER. Mr. President, I thank my distinguished colleague from
Vermont.
As noted earlier, legislation was introduced in the last Congress by
Senator Leahy and myself and others to deal with the problem of the
McCarran-Ferguson Act. We held hearings on this matter in the Judiciary
Committee. On recent matters which have evolved from Hurricane Katrina,
which will be amplified by the distinguished Senator from Mississippi,
Mr. Lott, there is a more pressing need to enter into this arena.
There have been various attempts over the years to limit McCarran-
Ferguson, and they have not succeeded because, as amplified in a more
detailed statement which I will include for the Record, there were safe
harbors proposed. They became very complicated. We have provided in
this legislation that the Commission decide what is to be violative of
the antitrust laws, a line which has been successful on the health
industry.
The economy of the United States functions much better when the
antitrust laws are available and enforceable. We see a great many
problems at the present time with what is happening with the sports
teams. The National Football League enjoys a limited antitrust
exemption, and they are proposing the Sunday ticket to DIRECTV, which
has a monopoly. Cable companies can't get the Sunday ticket. They now
have the Thursday to Saturday ticket. It is only on the NFL channel. I
had a talk with the commissioner of the NFL recently, who was living in
New York City, and he couldn't get the Sunday ticket because his
highrise wouldn't allow him to put a dish on top of the building.
May I note for the record the distinguished junior Senator from
Montana is nodding in the affirmative. He lives in an area--now he is
smiling. He lives in an area where you need a satellite, and his
constituents do, and some of mine in Pennsylvania do, and in my home
State of Kansas. Now baseball is coming along with extra innings and
exclusive to DIRECTV.
The impact of the antitrust exemption on the insurance industry has
been even more profound. But it is noted when we have the Federal Trade
Commission authorized to issue guidelines in identifying joint
practices where the antitrust concerns ought to be addressed, that is
the way to approach it, as the Federal Trade Commission did in the
health care industry.
I think this is a significant step forward, and I am glad to see that
the majority leader, Senator Reid, is behind this legislation. We can
pass it out of committee, we can take it up on the Senate floor, and I
think we can provide better protection for the American consumers.
Mr. President, I ask unanimous consent that the full text of my
statement be included in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

Insurance Industry Antitrust Enforcement Act of 2007

Mr. SPECTER. Mr. President, the Insurance Industry
Antitrust Enforcement Act of 2007 would subject the insurance
industry to the antitrust laws which apply to almost every
other industry in America. Congress enacted the McCarran-
Ferguson Act in 1945

[[Page S2046]]

in response to a controversial Supreme Court case in which
the Court held that the business of insurance constituted
interstate commerce. That ruling opened the door to federal
regulation of insurance, a business that had historically
been regulated and taxed by the states. McCarran-Ferguson
reaffirmed the power of the states to regulate and tax
insurance.
In doing so, Congress exempted the insurance industry
practices from antitrust scrutiny to the extent that such
practices are ``regulated by state law.'' Since then, the
courts have liberally interpreted the phrase ``regulated by
state law.'' They have held that insurance industry practices
are exempt from the antitrust laws so long as regulators have
been given jurisdiction over the challenged practices--
regardless of whether the regulators ever exercise that
jurisdiction.
Over the years, state regulators have either chosen not to
regulate, or failed to regulate, practices that would have
violated the antitrust laws absent McCarran-Ferguson. With
McCarran-Ferguson, such practices escape both regulatory and
federal antitrust oversight. The most notorious practices to
come to light involved bid-rigging and customer allocation by
insurance broker Marsh & McClennan and several of the
nation's largest insurers. Under the scheme, Marsh steered
unsuspecting clients to insurers with which it had lucrative
payoff agreements. To make the scheme work, Marsh solicited
fictitious bids from other complicit insurers to make the bid
submitted by the selected insurer--the one that offered Marsh
the highest payoff--seem competitive.
Even though the scheme eliminated competition among the
insurance companies that were involved, those companies could
not be prosecuted under federal antitrust law. Several states
prosecuted the insurance companies under a variety of state
laws, including antitrust laws, but federal prosecutors could
not bring their significant resources to bear. There simply
is no justification for that. Federal law enforcement should
have the power to prosecute such blatant violations of the
antitrust laws.
This is not the first attempt to subject the insurance
industry to federal antitrust law. In the wake of numerous
insolvencies, mismanagement and other misconduct by insurers
in the late 1980s, legislation was introduced repealing the
exemption. That legislation, introduced by Congressman
Brooks, faced opposition from insurers who claimed that many
industry practices engaged in jointly by insurance companies
were pro-competitive and necessary for smaller insurers. The
legislation provided a safe harbor, specifically listing the
practices of insurance companies that would be exempt from
the antitrust laws. However, it proved impossible to craft a
list of safe harbors for all the information that competing
insurers claimed they needed to share with one another. This
bill has avoided that problem.
More recently, some have argued that the answer to
insurance industry ills is full federal regulation. I do not
necessarily believe that stripping the states of their
authority to regulate the insurance industry is the answer.
This bill does not do that. It allows states to continue to
regulate their insurance industries. However, the existence
of state regulation is no reason to prevent federal
prosecutors from going after antitrust violators. And, there
is no reason to prevent federal prosecutors from going after
antitrust violators just because those violators happen to
work for insurance companies.
As I have said, allowing federal prosecutors to go after
those who violate the antitrust laws will not prevent states
from regulating the insurance industry. If a state is
actively supervising practices by its insurance industry that
might otherwise violate the antitrust laws, this legislation
would exempt that practice from the antitrust laws. Antitrust
law does not generally apply where a state is actively
regulating an industry. This is as it should be and the
legislation I introduce today, the Insurance Industry
Antitrust Act of 2007, incorporates that standard.
The Judiciary Committee held a hearing on this issue in
May. During the hearing, Marc Racicot, the President of the
American Insurance Association, a trade association composed
of the nation's largest insurers, acknowledged that ``every
state provides some form of antitrust regulation of
insurers.'' In other words, many states already enforce their
state antitrust laws with respect to insurers. So, I have to
ask, why have we tied the hands of federal antitrust
enforcers?
The insurers will argue that repealing the antitrust
exemption for insurers will create uncertainty by throwing
into question the legality of every joint practice engaged
in by insurers. They will argue that the legality of each
joint practice will have to be litigated in court.
However, this bill has been drafted to avoid such
litigation. Rather than incorporating a laundry list of
safe harbors, an approach that was taken in the past, the
bill would allow the Federal Trade Commission to issue
guidelines identifying joint practices that do not raise
antitrust concerns and would therefore not face scrutiny
from antitrust enforcers.
This is a job for which the Commission is well equipped. In
the past, the Commission along with the Justice Department
issued ``Statements of Antitrust Enforcement Policy in Health
Care.'' The Health Care Statements identified joint conduct
by health care providers that did not raise antitrust
concerns and therefore would likely escape scrutiny by
antitrust enforcers. The Health Care Statements were designed
to give health care providers certainty about the legality of
their joint conduct under the antitrust laws. Similar
guidelines for the insurance industry would provide insurers
with certainty, but at the same time, would ensure that joint
practices that are anticompetitive receive scrutiny from the
antitrust enforcement agencies.
Although many insurers oppose repeal of their antitrust
exemption, others support a repeal. In particular, the
Antitrust Section of the American Bar Association has long
supported repeal. During the Judiciary Committee's hearing,
the current head of the Antitrust Section, Donald Klawiter
noted the Section's nearly 20-year history of supporting
repeal. Klawiter testified that ``the benefits of antitrust
exemptions almost never outweigh the potential harm imposed
on society by the loss of competition.'' At the same hearing,
Robert Hunter, testifying on behalf of the Consumer
Federation of America, concluded that ``application of the
antitrust laws to the insurance industry could result in
double-digit savings for America's insurance consumers.''
It is my hope that this legislation will bring the benefits
of competition to the insurance industry and to consumers.
Too many consumers are paying too much for insurance due to
the collusive atmosphere that exists in the insurance
industry. This has become a particular problem along the Gulf
Coast, where insurers have shared hurricane loss projections,
which may result in double-digit premium increases for Gulf
Coast homeowners.
I strongly urge Members who are concerned about industry
exemption from the antitrust laws and collusive insurance
industry practices to support this important piece of
legislation.

Mr. LOTT. Mr. President, may I get some time under the agreement?
Mr. LEAHY. How much time would the distinguished Senator need?
Mr. LOTT. Probably 5 or 6 minutes. How much would you have left then?
I don't want to eat up all your time.
Mr. LEAHY. Again, we are using time that I--Mr. President, I ask
unanimous consent that my time be extended by 6 minutes, and that I be
allowed to yield that 6 minutes to the Senator from Mississippi.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. LOTT. Mr. President, let me say at the beginning, I appreciate
the courtesy of the Senator from Vermont and his comments on our effort
here; also, my colleague from Pennsylvania, Senator Specter, whom I
have discussed this issue with several times over the past year.
Let me begin at the beginning of this effort. I thank my colleagues
for this bipartisan effort. It shows what we can do when we work
together. Now, we have a long road to go, but this is being introduced
as a bipartisan measure with leaders from both sides and leaders of the
Judiciary Committee joining in cosponsoring this legislation.
How did I get interested in this area? Well, it is like so many
things in my life that go back only until August 29, 2005, when
Hurricane Katrina devastated my hometown and the area of my State that
I love so much, Mississippi and the gulf coast area. I had been active
in years gone by actually in the insurance area. I had done some law
practice in that area. I had done some defense work. But I never had
become steeped in the laws that apply to the industry because most of
the time I was dealing with an automobile accident case or something of
that nature.
Well, after Hurricane Katrina we learned a lot of lessons, and we
found a lot of new concerns in areas where we had to take action. One
of the commitments I have made to the people--and to the Senate because
the Senate has been so good in helping us in our recovery effort, in
changing the laws where applicable, the Stafford Act, in providing
funds. But one of the commitments I made as a result of that is to make
sure we take a look at what happened to us. What did we learn from
Katrina? What can we do to have more laws and the right things in place
after the next natural disaster--and there will be one--or any kind of
catastrophic disaster? We learned that the laws were not what they
should be. They needed to be changed. We have changed them some and we
need to change them some more. We learned the Federal agencies weren't
necessarily set up properly to do what needed to be done in the
aftermath of a disaster. We had questions about homeland security and
the Federal Emergency Management Administration and how the military,
the Coast Guard, and everybody interplayed together. So we have been
trying to make those corrections.
We need to ask ourselves: Do we need to give some additional thought
to how

[[Page S2047]]

we deal on a national level with the coverage of people or how we help
them recover? Do we need a national catastrophic insurance program? I
don't know that I am satisfied I know the answer yet, but I think we
need to ask that question in advance.
I also found, to my absolute horror, something I should have known,
which is that the insurance industry is not covered by antitrust laws.
They have a waiver. I said: How could that be? I remember hearing
discussion over the years about the McCarran-Ferguson Act, but I never
focused on it. When I realized that ratesetting and actually policy
actions by the industry were not covered by antitrust laws, I was
stunned. I understand you need a lot of information to decide on rates,
but that information can be used back and forth to in effect set rates
as an industry without making sure that it is not done in an
anticompetitive way. Do you mean that under this exemption, that
companies could collude on what actions they take or, even worse, what
actions they don't take, which is what we got into after Hurricane
Katrina? We had companies basically saying: Oh, no, no, you are covered
by Federal flood insurance. We don't have to pay under the household
policies for wind damage.
So as I got into it, I found that this happened back in 1944. At that
point, there was regulation of the insurance industry, but there was a
case styled the United States v. South Eastern Underwriters Association
which caused a change in how insurers were regulated. Then the Congress
immediately acted and said: Oh, no, we are going to say that federal
antitrust laws do not apply to this industry.
Soon the courts got into this issue and took a look at what happened.
They looked at the record. There were no hearings in the Senate. It was
passed quickly on a voice vote, and it went quickly through the House.
The conference report was debated for 2 days by the Senate, and most of
the debate, as I have looked at it, looks as though everybody thought
this was going to be a temporary moratorium. However, that is not the
way the courts have interpreted the laws.
Under the McCarran-Ferguson Act, insurers are exempt from antitrust
scrutiny, so long as they are regulated by State law. Then you get into
a patchwork of State laws: Do the States actively regulate them? Is
there a process for antitrust activities to be considered?
Over the years, many have advocated the repeal of this antitrust
exemption. The Judiciary Committee had hearings on this last summer.
The American Bar Association's antitrust section noted that the
organization for nearly 20 years has supported repeal of this
exemption. Look, there is a unique role for States to deal with
insurance questions and needs in those States, but my question beyond
that is: Should the Federal Government have the right to make sure
there are not anticompetitive activities, to make sure there is no
colluding? I think we need to take a serious look at that. This
legislation would do that. It would take away that exemption. It would
make the insurance industry subject to the same coverage of almost
every other corporation in America: antitrust legislation.
I know my time has expired. I thank the Chair for his leniency. I
thank Senator Leahy for doing this. I look forward to having the
hearings and testifying. This is wrong, Mr. President, and the Senate
in a bipartisan way should, and I believe will, correct it.
I yield the floor.
Mr. LEAHY. Mr. President, I thank my friend from Mississippi, and I
am proud to be joining with him on this. He and I have discussed this
several times over the past several months. I told him last fall I
would join with him on such legislation, and I am proud to do so.
Mr. REID. Mr. President, I want to express my support for the
``Insurance Industry Competition Act of 2007,'' which repeals the well-
known McCarran-Ferguson Act. McCarran-Ferguson gave States the
authority to regulate the business of insurance and exempted insurance
from the Federal antitrust laws. Unfortunately, McCarran-Ferguson came
about as a result of a Senator from my State of Nevada, McCarran, and a
Senator from Michigan, Ferguson. It was passed to give a few years of
relief to the insurance industry. In 1944, the United States Supreme
Court ruled against the industry-wide practice of cooperating to set
premium prices in United States v. Southeastern Underwriters
Association. Insurers argued that most companies were too small to rely
solely on their own experience in setting premiums. As a result of
these protests the McCarran-Ferguson Act was passed by Congress in
1945, exempting insurance-rate fixing from the Sherman Antitrust Act,
and placing responsibility for industry regulation in the hands of
state governments.
Now, some 60 plus years later, insurance companies are the only
businesses--other than Major League Baseball--not subject to antitrust
laws. Congress began investigating the effectiveness of State insurance
regulation in 1958, under the oversight of Senator O'Mahoney, who had
been a principal architect of the McCarran-Ferguson Act, and found
State regulation lacking, incapable of dealing with interstate and
international issues, and unwilling or unable to ``bring the blessings
of competition'' to insurance rate-making. The same thing is true
today, and its time we take action to remedy this situation. The
rationale for this exemption has long since passed. Insurance should be
like any other business--subject to antitrust laws.
Senator Leahy's bill would accomplish this. ``The Insurance Industry
Competition Act of 2007'' would repeal the exemption and simply give
the Department of Justice and the Federal Trade Commission the
authority to apply the antitrust laws to anticompetitive behavior by
insurance companies. Such oversight could ensure that the industry is
not engaging in the most egregious forms of anticompetitive conduct--
price fixing, agreements not to pay, and market allocations. This Act
would not affect the ability of each State to regulate the business of
insurance.
If insurers around the country are operating in an honest and
appropriate way, they should not object to being answerable under the
same Federal antitrust laws as virtually all other businesses. American
consumers should be confident that the cost of their insurance reflects
competitive market conditions, not collusive behavior, and they should
benefit through lower prices, more choices, and better services.
Perhaps nowhere has the insurance industry and its practices come
under as much scrutiny as along the Gulf Coast in the wake of
Hurricanes Katrina and Rita. Just yesterday, the AP reported that
``State Farm Insurance Cos. is suspending sales of any new commercial
or homeowner policies in Mississippi starting Friday.'' I ask Unanimous
Consent that a news article dated February 14, 2007, from the
Associated Press be printed in the Record. Insurers have been too often
denying claims and delaying payouts to residents of New Orleans and all
along the Gulf Coast instead of honoring their contractual commitments
to their customers, and thereby contributing to the rebuilding and
rejuvenation of the area. We need to act now to end this practice. I
thank Senators Leahy, Specter, and Lott for their work on this
important legislation.
There being no objection, the article was ordered to be printed in
the Record, as follows:

State Farm: No New Policies in Miss.

(By Michael Kunzelman)

State Farm Insurance Cos. is suspending sales of any new
commercial or homeowner policies in Mississippi starting
Friday, citing in part a wave of litigation it has faced
after Hurricane Katrina, a company official said Wednesday.
Mike Fernandez, vice president of public affairs for State
Farm, said Mississippi's ``current legal and political
environment is simply untenable. We're just not in a position
to accept any additional risk in this homeowners' market.''
Fernandez said the action was not a direct response to any
specific development in the litigation. That litigation has
included a recent federal jury's $2.5 million punitive damage
award to a policyholder who sued State Farm for refusing to
cover the 2005 hurricane's storm surge damage.
State Farm, the largest homeowners insurer in Mississippi
with more than 30 percent of the market, agreed to settle
hundreds of lawsuits by policyholders and reopen and pay
thousands of other disputed claims. The landmark deal is
potentially worth hundreds of millions of dollars for
Mississippi homeowners devastated by Katrina.
______

By Mr. FEINGOLD (for himself and Ms. Mikulski):

[[Page S2048]]

S. 620. A bill to establish a demonstration project to train
unemployed workers for employment as health care professionals, and for
other purposes; to the Committee on Health, Education, Labor, and
Pensions.
Mr. FEINGOLD. Mr. President, today I am introducing the third in a
series of bills intended to support American companies and American
workers. Earlier this week, I introduced a resolution which would set
some minimum standards for future trade agreements into which our
country enters, and legislation which would strengthen the Buy American
Act. Today I am introducing legislation that would help workers who
have lost their manufacturing or service sector jobs to be retrained
for jobs in high-demand health care fields. I am pleased that my
colleague, Senator Mikulski, is cosponsoring this important legislation
and I look forward to working with her to advance it during the 110th
Congress.
According to statistics from the Department of Labor, Wisconsin has
lost over 90,000 manufacturing jobs between January 2000 and November
2006. Nationally, the country has lost around 3 million manufacturing
jobs since January 2001, yet the administration has continued to
support policies that lead to the outsourcing of American jobs. I
continue to be deeply troubled by the Bush Administration's contention
that the outsourcing of American service sector and other jobs is good
for the economy. I am concerned about the message that this policy
sends to Wisconsinites and all Americans who are currently employed in
these sectors.
There is something of a silver lining to the looming cloud of
manufacturing and other jobs loss: the country's workforce development
system.
In spite of stretched resources and long waiting lists for services,
our workforce development boards are making a tremendous effort to
retrain laid-off workers and other job seekers for new jobs. And this
effort is clearly evident in Wisconsin, where my State's workforce
development boards--despite shoestring budgets--are leading the way in
finding innovative solutions to retraining workers for new careers.
I strongly support the work of these agencies, and have urged the
Administration and Senate appropriators to provide adequate funding for
the job training programs authorized by the Workforce Investment Act. I
look forward to the reauthorization of the Workforce Investment Act
this year and I will continue to work to ensure that the workforce
development boards in my state and across our country receive the
resources that they need to help job seekers get the training they need
to be successful.
I am committed to finding resources to retrain those who have been
laid off from the manufacturing and service sectors and who wish to
find new jobs in high-demand fields such as health care.
As most of my colleagues know all too well, we are facing a
significant shortage of health care workers. Congress has made some
progress in addressing the nursing shortage, but we need to expand our
efforts. Shortages of health professionals pose a real threat to the
health of our communities by impacting access to timely, high-quality
health care. Studies have shown that shortages of nurses in our
hospitals and health facilities increase medical errors, which directly
affects patient health.
As our population ages, and the baby-boomers need more health care,
our need for all types of health professionals is only going to
increase. This is particularly true for the field of long-term care.
According to the Bureau of Labor Statistics, we are going to need an
additional 1.4 million nursing aides, home health aides, and other
health professionals in long-term care before the year 2014. In total,
there will be almost 1.7 million job openings in health care support
occupations through 2012.
As our demand for health care workers grows, so does the number of
jobs available within this sector. According to the Wisconsin
Department of Workforce Development, the surging job growth in health
care will translate into a real need for workers, and real opportunity.
In Wisconsin alone, there will be an additional 61,910 health care
positions by 2014. This represents a 27 percent increase in jobs in
health care by 2014.
Workforce development agencies in my home State of Wisconsin are
already working to support displaced workers in their communities by
training them for health care jobs, since there is a real need for
workers in these fields. These agencies are helping communities get and
maintain access to high-quality health care by ensuring that there are
enough health care workers to care for their communities.
As the executive director of one of the workforce development boards
in my State put it, ``[t]here are simply not many good quality jobs to
replace manufacturing jobs lost to rural communities. The medical
professions, by offering a `living wage' and good benefits, provide an
excellent alternative to manufacturing for sustaining a higher, family-
oriented standard of living.''
I believe we should support our communities in these efforts by
providing them with the resources they need to establish, sustain, or
expand these important programs. For that reason, today I am
introducing the Community-Based Health Care Retraining Act. This bill
would amend the Workforce Investment Act to authorize a demonstration
project to provide grants to community-based coalitions, led by local
workforce development boards, to create programs to retrain unemployed
workers who wish to obtain new jobs in the health care professions. My
bill would authorize a total of $25 million for grants between $100,000
and $500,000, and, in the interest of fiscal responsibility, my
legislation is fully offset.
This bill will help provide communities with the resources they need
to run retraining programs for the health professions. The funds could
be used for a variety of purposes, from increasing the capacity of our
schools and training facilities, to providing financial and social
support for workers who are in retraining programs. This bill allows
for flexibility in the use of grant funds because I believe that
communities know best about the resources they need to run an efficient
program.
This bill represents a nexus in my efforts to support workers whose
jobs have been shipped overseas and to ensure that all Americans have
access to the high-quality health care that they deserve. By providing
targeted assistance to train laid-off workers who wish to obtain new
jobs in the health care sector, we can both help unemployed Americans
and improve the availability and quality of health care that is
available in our communities.
I am pleased that this bill is supported by a variety of
organizations that are committed to providing high-quality job training
and health care services, including: the Wisconsin Association of Job
Training Executives, the Wisconsin Hospital Association, Madison Area
Technical College, the Northwest Wisconsin Concentrated Employment
Program, the Workforce Development Board of South Central Wisconsin,
the Bay Area Workforce Development Board, the Healthcare Workforce
Network, the Southwest Wisconsin Workforce Development Board, Sauk
County Development Corporation, the American Osteopathic Society, Umos,
the Fox Valley Workforce Development Board, and the West Central
Wisconsin Workforce Development Board.
In order to ensure that our workers are able to compete in the new
economy, we must ensure that they have the tools they need to be
trained or retrained for high-demand jobs such as those in the health
care field. My bill is a small step toward providing the resources
necessary to achieve this goal. I will continue to work to strengthen
the American manufacturing sector and to support those workers who have
been displaced due to bad trade agreements and other policies that have
led to the loss of American jobs.
I ask unanimous consent that the text of this 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. 620

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 ``Community-Based Health Care
Retraining Act''.

SEC. 2. HEALTH PROFESSIONS TRAINING DEMONSTRATION PROJECT.

Section 171 of the Workforce Investment Act of 1998 (29
U.S.C. 2916) is amended by adding at the end the following:
``(e) Health Professions Training Demonstration Project.--

[[Page S2049]]

``(1) Definitions.--In this subsection:
``(A) Covered community.--The term `covered community'
means a community or region that--
``(i) has experienced a significant percentage decline in
positions in the manufacturing or service sectors; and
``(ii) is determined by the Secretary of Health and Human
Services (in consultation with the medical community) to be
an area with a shortage of health care professionals
described in clause (i) or (ii) of subparagraph (C).
``(B) Covered worker.--The term `covered worker' means an
individual who--
``(i)(I) has been terminated or laid off, or who has
received a notice of termination or layoff, from employment
in a manufacturing or service sector;
``(II)(aa) is eligible for or has exhausted entitlement to
unemployment compensation; or
``(bb) has been employed for a duration sufficient to
demonstrate, to the appropriate entity at a one-stop center
referred to in section 134(c), attachment to the workforce,
but is not eligible for unemployment compensation due to
insufficient earnings or having performed services for an
employer that were not covered under a State unemployment
compensation law; and
``(III) is unlikely to return to a previous industry or
occupation; or
``(ii)(I) has been terminated or laid off, or has received
a notice of termination or layoff, from employment in a
manufacturing or service sector as a result of any permanent
closure of, or any substantial layoff at, a plant, facility,
or enterprise; or
``(II) is employed in a manufacturing or service sector at
a facility at which the employer has made a general
announcement that such facility will close within 180 days.
``(C) Health care professional.--The term `health care
professional'--
``(i) means an individual who is involved with--

``(I) the delivery of health care services, or related
services, pertaining to--

``(aa) the identification, evaluation, and prevention of
diseases, disorders, or injuries; or
``(bb) home-based or community-based long-term care;

``(II) the delivery of dietary and nutrition services; or
``(III) rehabilitation and health systems management; and

``(ii) with respect to a covered community to be served
through a grant made under paragraph (3), includes
individuals in health care professions and jobs for which
there is a shortage in the community, as determined by the
Secretary of Health and Human Services (in consultation with
the medical community), giving consideration to the amount of
training time required to retrain the covered workers for the
health care professions and jobs.
``(D) Tribal college or university.--The term `tribal
college or university' means--
``(i) a tribally controlled college or university, as
defined in section 2 of the Tribally Controlled College or
University Assistance Act of 1978 (25 U.S.C. 1801);
``(ii) Dine College, authorized in the Navajo Community
College Act (25 U.S.C. 640a et seq.); and
``(iii) any of the 1994 Institutions, as defined in section
532 of the Equity in Educational Land-Grant Status Act of
1994 (7 U.S.C. 301 note).
``(2) Establishment of project.--In accordance with
subsection (b), the Secretary shall establish and carry out a
health professions training demonstration project.
``(3) Grants.--In carrying out the project, the Secretary,
after consultation with the Secretary of Health and Human
Services, shall make grants to eligible entities to enable
the entities to carry out programs in covered communities to
train covered workers for employment as health care
professionals. The Secretary shall make each grant in an
amount of not less than $100,000 and not more than $500,000.
``(4) Eligible entities.--Notwithstanding subsection
(b)(2)(B), to be eligible to receive a grant under this
subsection to carry out a program in a covered community, an
entity shall be a partnership that is--
``(A) under the direction of a local workforce investment
board established under section 117 that is serving the
covered community; and
``(B) composed of members serving the covered community,
such as--
``(i) an institution of higher education that provides a 4-
year program of instruction;
``(ii) an accredited community college;
``(iii) an accredited vocational or technical school;
``(iv) a tribal college or university;
``(v) a health clinic or hospital;
``(vi) a home-based or community-based long-term care
facility or program; or
``(vii) a health care facility administered by the
Secretary of Veterans Affairs.
``(5) Applications.--To be eligible to receive a grant
under this subsection, an entity shall submit an application
to the Secretary at such time, in such manner, and containing
such information as the Secretary may require, including, at
a minimum--
``(A) a proposal to use the grant funds to establish or
expand a training program in order to train covered workers
for employment as health care professionals (including
paraprofessionals);
``(B) information demonstrating the need for the training
and support services to be provided through the program;
``(C) information describing the manner in which the entity
will expend the grant funds, and the activities to be carried
out with the funds;
``(D) information demonstrating that the entity meets the
requirements of paragraph (4); and
``(E) with respect to training programs carried out by the
applicant, information--
``(i) on the graduation rates of the programs involved;
``(ii) on the retention measures carried out by the
applicant;
``(iii) on the length of time necessary to complete the
training programs of the applicant; and
``(iv) on the number of qualified covered workers that are
refused admittance into the training programs because of lack
of capacity.
``(6) Selection.--In making grants under paragraph (3), the
Secretary, after consultation with the Secretary of Health
and Human Services, shall--
``(A) consider the information submitted by the eligible
entities under paragraph (5)(E); and
``(B) select--
``(i) eligible entities submitting applications that meet
such criteria as the Secretary of Labor determines to be
appropriate; and
``(ii) among such entities, the eligible entities serving
the covered communities with the greatest need for the grants
and the greatest potential to benefit from the grants.
``(7) Use of funds.--
``(A) In general.--An entity that receives a grant under
this subsection shall use the funds made available through
the grant for training and support services that meet the
needs described in the application submitted under paragraph
(5), which may include--
``(i) increasing capacity, subject to subparagraph (B), at
an educational institution or training center to train
individuals for employment as health professionals, such as
by--

``(I) expanding a facility, subject to subparagraph (B);
``(II) expanding course offerings;
``(III) hiring faculty;
``(IV) providing a student loan repayment program for the
faculty;
``(V) establishing or expanding clinical education
opportunities;
``(VI) purchasing equipment, such as computers, books,
clinical supplies, or a patient simulator; or
``(VII) conducting recruitment; or

``(ii) providing support services for covered workers
participating in the training, such as--

``(I) providing tuition assistance;
``(II) establishing or expanding distance education
programs;
``(III) providing transportation assistance; or
``(IV) providing child care.

``(B) Limitation.--To be eligible to use the funds to
expand a facility, the eligible entity shall demonstrate to
the Secretary in an application submitted under paragraph (5)
that the entity can increase the capacity described in
subparagraph (A)(i) of such facility only by expanding the
facility.
``(8) Funding.--Of the amounts appropriated to, and
available at the discretion of, the Secretary or the
Secretary of Health and Human Services for programmatic and
administrative expenditures, a total of $25,000,000 shall be
used to establish and carry out the demonstration project
described in paragraph (2) in accordance with this
subsection.''.
______

By Mr. FEINGOLD (for himself, Mr. Grassley, Mr. Kennedy, Mr.
Lieberman, and Mr. Inouye):
S. 621. A bill to establish commissions to review the facts and
circumstances surrounding injustices suffered by European Americans,
European Latin Americans, and Jewish refugees during World War II; to
the Committee on the Judiciary.
Mr. FEINGOLD. Mr. President, today I introduce the Wartime Treatment
Study Act. This bill would create two fact-finding commissions: one
commission to review the U.S. government's treatment of German
Americans, Italian Americans, and European Latin Americans during World
War II, and another commission to review the U.S. government's
treatment of Jewish refugees fleeing Nazi persecution during World War
II. This bill is long overdue.
I am very pleased that my colleagues Senators Grassley, Kennedy,
Lieberman and Inouye have joined me as cosponsors of this important
bill. I thank them for their support. And I thank Congressman Wexler,
who has been the unflagging champion of this legislation in the House
of Representatives.
The victory of America and its allies in the Second World War was a
triumph for freedom, justice, and human rights. The courage displayed
by so many Americans, of all ethnic origins, should be a source of
great pride for all Americans.
But, at the same time that so many brave Americans fought for freedom
in

[[Page S2050]]

Europe and the Pacific, the U.S. government was curtailing the freedom
of people here at home. While, it is, of course, the right of every
nation to protect itself during wartime, the U.S. Government must
respect the basic freedoms for which so many Americans have given their
lives to defend. War tests our principles and our values. And as our
Nation's recent experience has shown, it is during times of war and
conflict, when our fears are high and our principles are tested most,
that we must be even more vigilant to guard against violations of the
basic freedoms guaranteed by the Constitution.
Many Americans are aware that during World War II, under the
authority of Executive Order 9066, our government forced more than
100,000 ethnic Japanese from their homes and ultimately into internment
camps. Japanese Americans were forced to leave their homes, their
livelihoods, and their communities and were held behind barbed wire and
military guard by their own government. Through the work of the
Commission on Wartime Relocation and Internment of Civilians, created
by Congress in 1980, this shameful event finally received the official
acknowledgement and condemnation it deserved. Under the Civil Liberties
Act of 1988, people of Japanese ancestry who were subjected to
relocation or internment later received an apology and reparations on
behalf of the people of the United States.
February 19, 2007, is the ``Day of Remembrance,'' the 65th
anniversary of the signing of Executive Order 9066. On this day, we
should remember the freedoms all of these individuals were forced to
give up, and resolve never to make these mistakes again.
While I commend our government for finally recognizing and
apologizing for the mistreatment of Japanese Americans during World War
II, I believe that it is time that the government also acknowledge the
mistreatment experienced by many German Americans, Italian Americans,
and European Latin Americans, as well as Jewish refugees.
The Wartime Treatment Study Act would create two independent, fact-
finding commissions to review this unfortunate history, so that
Americans can understand why it happened and work to ensure that it
never happens again. One commission will review the treatment by the
U.S. government of German Americans, Italian Americans, and other
European Americans, as well as European Latin Americans, during World
War II.
I believe that most Americans are unaware that, as was the case with
Japanese Americans, approximately 11,000 ethnic Germans, 3,200 ethnic
Italians, and scores of Bulgarians, Hungarians, Romanians or other
European Americans living in America were taken from their homes and
placed in internment camps during World War II. We must learn from this
history and explore why we turned on our fellow Americans and failed to
protect their basic freedoms.
A second commission created by this bill will review the treatment by
the U.S. government of Jewish refugees who were fleeing Nazi
persecution and genocide. We must review the facts here as well and
determine how restrictive immigration policies failed to provide
adequate safe harbor to Jewish refugees fleeing the persecution of Nazi
Germany. It is a horrible truth that the United States turned away
thousands of refugees, delivering many refugees to their deaths at the
hands of the Nazi regime.
As I mentioned earlier, there has been a measure of justice for
Japanese Americans who were denied their liberty and property. It is
now time for the U.S. government to complete the accounting of this
period in our nation's history. It is time to create independent, fact-
finding commissions to conduct a full and through review of the
treatment of all European Americans, European Latin Americans, and
Jewish refugees during World War II.
Up to this point, there has been no justice for the thousands of
German Americans, Italian Americans, and other European Americans who
were branded ``enemy aliens'' and then taken from their homes,
subjected to curfews, limited in their travel, deprived of their
personal property, and, in the worst cases, placed in internment camps.
There has been no justice for Latin Americans of European descent who
were shipped to the United States and sometimes repatriated or deported
to hostile, war-torn European Axis powers, often in exchange for
Americans being held in those countries.
Finally, there has been no justice for the thousands of Jews, like
those aboard the German vessel the St. Louis, who sought refuge from
hostile Nazi treatment but were callously turned away at America's
shores.
The injustices to European Americans, European Latin Americans, and
Jewish refugees occurred more than fifty years ago. Americans can learn
from these tragedies now, while the people who survived these
injustices are still with us, and are still here to teach us. We cannot
put this off any longer. If we wait, the people who were affected will
no longer be here to know that Congress has at last recognized their
sacrifice and resolved to learn from the mistakes of the past.
We should never allow this part of our Nation's history to repeat
itself. And, while we should be proud of our Nation's triumph in World
War II, we should not let that justifiable pride blind us to the
treatment of some Americans by their own government.
As the Day of Remembrance approaches, I urge my colleagues to join me
in supporting the Wartime Treatment Study Act, and to allow this bill
to become law as soon as possible. I have been seeking to enact this
legislation for six years. It is time for a full accounting of this
tragic chapter in our Nation's history.
I ask unanimous consent that the text of the Wartime Treatment Study
Act 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. 621

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 ``Wartime Treatment Study
Act''.

SEC. 2. FINDINGS.

Congress makes the following findings:
(1) During World War II, the United States Government
deemed as ``enemy aliens'' more than 600,000 Italian-born and
300,000 German-born United States resident aliens and their
families and required them to carry Certificates of
Identification and limited their travel and personal property
rights. At that time, these groups were the 2 largest
foreign-born groups in the United States.
(2) During World War II, the United States Government
arrested, interned, or otherwise detained thousands of
European Americans, some remaining in custody for years after
cessation of World War II hostilities, and repatriated,
exchanged, or deported European Americans, including
American-born children, to European Axis nations, many to be
exchanged for Americans held in those nations.
(3) Pursuant to a policy coordinated by the United States
with Latin American nations, many European Latin Americans,
including German and Austrian Jews, were arrested, brought to
the United States, and interned. Many were later expatriated,
repatriated, or deported to European Axis nations during
World War II, many to be exchanged for Americans and Latin
Americans held in those nations.
(4) Millions of European Americans served in the armed
forces and thousands sacrificed their lives in defense of the
United States.
(5) The wartime policies of the United States Government
were devastating to the Italian American and German American
communities, individuals, and their families. The detrimental
effects are still being experienced.
(6) Prior to and during World War II, the United States
restricted the entry of Jewish refugees who were fleeing
persecution or genocide and sought safety in the United
States. During the 1930's and 1940's, the quota system,
immigration regulations, visa requirements, and the time
required to process visa applications affected the number of
Jewish refugees, particularly those from Germany and Austria,
who could gain admittance to the United States.
(7) The United States Government should conduct an
independent review to fully assess and acknowledge these
actions. Congress has previously reviewed the United States
Government's wartime treatment of Japanese Americans through
the Commission on Wartime Relocation and Internment of
Civilians. An independent review of the treatment of German
Americans and Italian Americans and of Jewish refugees
fleeing persecution and genocide has not yet been undertaken.
(8) Time is of the essence for the establishment of
commissions, because of the increasing danger of destruction
and loss of relevant documents, the advanced age of potential
witnesses and, most importantly, the advanced age of those
affected by the United States Government's policies. Many who
suffered have already passed away and will never know of this
effort.

[[Page S2051]]

SEC. 3. DEFINITIONS.

In this Act:
(1) During world war ii.--The term ``during World War II''
refers to the period between September 1, 1939, through
December 31, 1948.
(2) European americans.--
(A) In general.--The term ``European Americans'' refers to
United States citizens and resident aliens of European
ancestry, including Italian Americans, German Americans,
Hungarian Americans, Romanian Americans, and Bulgarian
Americans.
(B) Italian americans.--The term ``Italian Americans''
refers to United States citizens and resident aliens of
Italian ancestry.
(C) German americans.--The term ``German Americans'' refers
to United States citizens and resident aliens of German
ancestry.
(3) European latin americans.--The term ``European Latin
Americans'' refers to persons of European ancestry, including
Italian or German ancestry, residing in a Latin American
nation during World War II.
(4) Latin american nation.--The term ``Latin American
nation'' refers to any nation in Central America, South
America, or the Carribean.

TITLE I--COMMISSION ON WARTIME TREATMENT OF EUROPEAN AMERICANS

SEC. 101. ESTABLISHMENT OF COMMISSION ON WARTIME TREATMENT OF
EUROPEAN AMERICANS.

(a) In General.--There is established the Commission on
Wartime Treatment of European Americans (referred to in this
title as the ``European American Commission'').
(b) Membership.--The European American Commission shall be
composed of 7 members, who shall be appointed not later than
90 days after the date of enactment of this Act as follows:
(1) Three members shall be appointed by the President.
(2) Two members shall be appointed by the Speaker of the
House of Representatives, in consultation with the minority
leader.
(3) Two members shall be appointed by the majority leader
of the Senate, in consultation with the minority leader.
(c) Terms.--The term of office for members shall be for the
life of the European American Commission. A vacancy in the
European American Commission shall not affect its powers, and
shall be filled in the same manner in which the original
appointment was made.
(d) Representation.--The European American Commission shall
include 2 members representing the interests of Italian
Americans and 2 members representing the interests of German
Americans.
(e) Meetings.--The President shall call the first meeting
of the European American Commission not later than 120 days
after the date of enactment of this Act.
(f) Quorum.--Four members of the European American
Commission shall constitute a quorum, but a lesser number may
hold hearings.
(g) Chairman.--The European American Commission shall elect
a Chairman and Vice Chairman from among its members. The term
of office of each shall be for the life of the European
American Commission.
(h) Compensation.--
(1) In general.--Members of the European American
Commission shall serve without pay.
(2) Reimbursement of expenses.--All members of the European
American Commission shall be reimbursed for reasonable travel
and subsistence, and other reasonable and necessary expenses
incurred by them in the performance of their duties.

SEC. 102. DUTIES OF THE EUROPEAN AMERICAN COMMISSION.

(a) In General.--It shall be the duty of the European
American Commission to review the United States Government's
wartime treatment of European Americans and European Latin
Americans as provided in subsection (b).
(b) Scope of Review.--The European American Commission's
review shall include the following:
(1) A comprehensive review of the facts and circumstances
surrounding United States Government actions during World War
II with respect to European Americans and European Latin
Americans pursuant to the Alien Enemies Acts (50 U.S.C. 21 et
seq.), Presidential Proclamations 2526, 2527, 2655, 2662, and
2685, Executive Orders 9066 and 9095, and any directive of
the United States Government pursuant to such law,
proclamations, or executive orders respecting the
registration, arrest, exclusion, internment, exchange, or
deportation of European Americans and European Latin
Americans. This review shall include an assessment of the
underlying rationale of the United States Government's
decision to develop related programs and policies, the
information the United States Government received or acquired
suggesting the related programs and policies were necessary,
the perceived benefit of enacting such programs and policies,
and the immediate and long-term impact of such programs and
policies on European Americans and European Latin Americans
and their communities.
(2) A comprehensive review of United States Government
action during World War II with respect to European Americans
and European Latin Americans pursuant to the Alien Enemies
Acts (50 U.S.C. 21 et seq.), Presidential Proclamations 2526,
2527, 2655, 2662, and 2685, Executive Orders 9066 and 9095,
and any directive of the United States Government pursuant to
such law, proclamations, or executive orders, including
registration requirements, travel and property restrictions,
establishment of restricted areas, raids, arrests,
internment, exclusion, policies relating to the families and
property that excludees and internees were forced to abandon,
internee employment by American companies (including a list
of such companies and the terms and type of employment),
exchange, repatriation, and deportation, and the immediate
and long-term effect of such actions, particularly
internment, on the lives of those affected. This review shall
include a list of--
(A) all temporary detention and long-term internment
facilities in the United States and Latin American nations
that were used to detain or intern European Americans and
European Latin Americans during World War II (in this
paragraph referred to as ``World War II detention
facilities'');
(B) the names of European Americans and European Latin
Americans who died while in World War II detention facilities
and where they were buried;
(C) the names of children of European Americans and
European Latin Americans who were born in World War II
detention facilities and where they were born; and
(D) the nations from which European Latin Americans were
brought to the United States, the ships that transported them
to the United States and their departure and disembarkation
ports, the locations where European Americans and European
Latin Americans were exchanged for persons held in European
Axis nations, and the ships that transported them to Europe
and their departure and disembarkation ports.
(3) A brief review of the participation by European
Americans in the United States Armed Forces including the
participation of European Americans whose families were
excluded, interned, repatriated, or exchanged.
(4) A recommendation of appropriate remedies, including how
civil liberties can be protected during war, or an actual,
attempted, or threatened invasion or incursion, an assessment
of the continued viability of the Alien Enemies Acts (50
U.S.C. 21 et seq.), and public education programs related to
the United States Government's wartime treatment of European
Americans and European Latin Americans during World War II.
(c) Field Hearings.--The European American Commission shall
hold public hearings in such cities of the United States as
it deems appropriate.
(d) Report.--The European American Commission shall submit
a written report of its findings and recommendations to
Congress not later than 18 months after the date of the first
meeting called pursuant to section 101(e).

SEC. 103. POWERS OF THE EUROPEAN AMERICAN COMMISSION.

(a) In General.--The European American Commission or, on
the authorization of the Commission, any subcommittee or
member thereof, may, for the purpose of carrying out the
provisions of this title, hold such hearings and sit and act
at such times and places, and request the attendance and
testimony of such witnesses and the production of such books,
records, correspondence, memorandum, papers, and documents as
the Commission or such subcommittee or member may deem
advisable. The European American Commission may request the
Attorney General to invoke the aid of an appropriate United
States district court to require, by subpoena or otherwise,
such attendance, testimony, or production.
(b) Government Information and Cooperation.--The European
American Commission may acquire directly from the head of any
department, agency, independent instrumentality, or other
authority of the executive branch of the Government,
available information that the European American Commission
considers useful in the discharge of its duties. All
departments, agencies, and independent instrumentalities, or
other authorities of the executive branch of the Government
shall cooperate with the European American Commission and
furnish all information requested by the European American
Commission to the extent permitted by law, including
information collected under the Commission on Wartime and
Internment of Civilians Act (Public Law 96-317; 50 U.S.C.
App. 1981 note) and the Wartime Violation of Italian
Americans Civil Liberties Act (Public Law 106-451; 50 U.S.C.
App. 1981 note). For purposes of section 552a(b)(9) of title
5, United States Code (commonly known as the ``Privacy Act of
1974''), the European American Commission shall be deemed to
be a committee of jurisdiction.

SEC. 104. ADMINISTRATIVE PROVISIONS.

The European American Commission is authorized to--
(1) appoint and fix the compensation of such personnel as
may be necessary, without regard to the provisions of title
5, United States Code, governing appointments in the
competitive service, and without regard to the provisions of
chapter 51 and subchapter III of chapter 53 of such title
relating to classification and General Schedule pay rates,
except that the compensation of any employee of the
Commission may not exceed a rate equivalent to the rate
payable under GS-15 of the General Schedule under section
5332 of such title;
(2) obtain the services of experts and consultants in
accordance with the provisions of section 3109 of such title;
(3) obtain the detail of any Federal Government employee,
and such detail shall be without reimbursement or
interruption or loss of civil service status or privilege;
(4) enter into agreements with the Administrator of General
Services for procurement

[[Page S2052]]

of necessary financial and administrative services, for which
payment shall be made by reimbursement from funds of the
Commission in such amounts as may be agreed upon by the
Chairman of the Commission and the Administrator;
(5) procure supplies, services, and property by contract in
accordance with applicable laws and regulations and to the
extent or in such amounts as are provided in appropriation
Acts; and
(6) enter into contracts with Federal or State agencies,
private firms, institutions, and agencies for the conduct of
research or surveys, the preparation of reports, and other
activities necessary to the discharge of the duties of the
Commission, to the extent or in such amounts as are provided
in appropriation Acts.

SEC. 105. FUNDING.

Of the amounts authorized to be appropriated to the
Department of Justice, $600,000 shall be available to carry
out this title.

SEC. 106. SUNSET.

The European American Commission shall terminate 60 days
after it submits its report to Congress.

TITLE II--COMMISSION ON WARTIME TREATMENT OF JEWISH REFUGEES

SEC. 201. ESTABLISHMENT OF COMMISSION ON WARTIME TREATMENT OF
JEWISH REFUGEES.

(a) In General.--There is established the Commission on
Wartime Treatment of Jewish Refugees (referred to in this
title as the ``Jewish Refugee Commission'').
(b) Membership.--The Jewish Refugee Commission shall be
composed of 7 members, who shall be appointed not later than
90 days after the date of enactment of this Act as follows:
(1) Three members shall be appointed by the President.
(2) Two members shall be appointed by the Speaker of the
House of Representatives, in consultation with the minority
leader.
(3) Two members shall be appointed by the majority leader
of the Senate, in consultation with the minority leader.
(c) Terms.--The term of office for members shall be for the
life of the Jewish Refugee Commission. A vacancy in the
Jewish Refugee Commission shall not affect its powers, and
shall be filled in the same manner in which the original
appointment was made.
(d) Representation.--The Jewish Refugee Commission shall
include 2 members representing the interests of Jewish
refugees.
(e) Meetings.--The President shall call the first meeting
of the Jewish Refugee Commission not later than 120 days
after the date of enactment of this Act.
(f) Quorum.--Four members of the Jewish Refugee Commission
shall constitute a quorum, but a lesser number may hold
hearings.
(g) Chairman.--The Jewish Refugee Commission shall elect a
Chairman and Vice Chairman from among its members. The term
of office of each shall be for the life of the Jewish Refugee
Commission.
(h) Compensation.--
(1) In general.--Members of the Jewish Refugee Commission
shall serve without pay.
(2) Reimbursement of expenses.--All members of the Jewish
Refugee Commission shall be reimbursed for reasonable travel
and subsistence, and other reasonable and necessary expenses
incurred by them in the performance of their duties.

SEC. 202. DUTIES OF THE JEWISH REFUGEE COMMISSION.

(a) In General.--It shall be the duty of the Jewish Refugee
Commission to review the United States Government's refusal
to allow Jewish and other refugees fleeing persecution or
genocide in Europe entry to the United States as provided in
subsection (b).
(b) Scope of Review.--The Jewish Refugee Commission's
review shall cover the period between January 1, 1933,
through December 31, 1945, and shall include, to the greatest
extent practicable, the following:
(1) A review of the United States Government's decision to
deny Jewish and other refugees fleeing persecution or
genocide entry to the United States, including a review of
the underlying rationale of the United States Government's
decision to refuse the Jewish and other refugees entry, the
information the United States Government received or acquired
suggesting such refusal was necessary, the perceived benefit
of such refusal, and the impact of such refusal on the
refugees.
(2) A review of Federal refugee law and policy relating to
those fleeing persecution or genocide, including
recommendations for making it easier in the future for
victims of persecution or genocide to obtain refuge in the
United States.
(c) Field Hearings.--The Jewish Refugee Commission shall
hold public hearings in such cities of the United States as
it deems appropriate.
(d) Report.--The Jewish Refugee Commission shall submit a
written report of its findings and recommendations to
Congress not later than 18 months after the date of the first
meeting called pursuant to section 201(e).

SEC. 203. POWERS OF THE JEWISH REFUGEE COMMISSION.

(a) In General.--The Jewish Refugee Commission or, on the
authorization of the Commission, any subcommittee or member
thereof, may, for the purpose of carrying out the provisions
of this title, hold such hearings and sit and act at such
times and places, and request the attendance and testimony of
such witnesses and the production of such books, records,
correspondence, memorandum, papers, and documents as the
Commission or such subcommittee or member may deem advisable.
The Jewish Refugee Commission may request the Attorney
General to invoke the aid of an appropriate United States
district court to require, by subpoena or otherwise, such
attendance, testimony, or production.
(b) Government Information and Cooperation.--The Jewish
Refugee Commission may acquire directly from the head of any
department, agency, independent instrumentality, or other
authority of the executive branch of the Government,
available information that the Jewish Refugee Commission
considers useful in the discharge of its duties. All
departments, agencies, and independent instrumentalities, or
other authorities of the executive branch of the Government
shall cooperate with the Jewish Refugee Commission and
furnish all information requested by the Jewish Refugee
Commission to the extent permitted by law, including
information collected as a result of the Commission on
Wartime and Internment of Civilians Act (Public Law 96-317;
50 U.S.C. App. 1981 note) and the Wartime Violation of
Italian Americans Civil Liberties Act (Public Law 106-451; 50
U.S.C. App. 1981 note). For purposes of section 552a(b)(9) of
title 5, United States Code (commonly known as the ``Privacy
Act of 1974''), the Jewish Refugee Commission shall be deemed
to be a committee of jurisdiction.

SEC. 204. ADMINISTRATIVE PROVISIONS.

The Jewish Refugee Commission is authorized to--
(1) appoint and fix the compensation of such personnel as
may be necessary, without regard to the provisions of title
5, United States Code, governing appointments in the
competitive service, and without regard to the provisions of
chapter 51 and subchapter III of chapter 53 of such title
relating to classification and General Schedule pay rates,
except that the compensation of any employee of the
Commission may not exceed a rate equivalent to the rate
payable under GS-15 of the General Schedule under section
5332 of such title;
(2) obtain the services of experts and consultants in
accordance with the provisions of section 3109 of such title;
(3) obtain the detail of any Federal Government employee,
and such detail shall be without reimbursement or
interruption or loss of civil service status or privilege;
(4) enter into agreements with the Administrator of General
Services for procurement of necessary financial and
administrative services, for which payment shall be made by
reimbursement from funds of the Commission in such amounts as
may be agreed upon by the Chairman of the Commission and the
Administrator;
(5) procure supplies, services, and property by contract in
accordance with applicable laws and regulations and to the
extent or in such amounts as are provided in appropriation
Acts; and
(6) enter into contracts with Federal or State agencies,
private firms, institutions, and agencies for the conduct of
research or surveys, the preparation of reports, and other
activities necessary to the discharge of the duties of the
Commission, to the extent or in such amounts as are provided
in appropriation Acts.

SEC. 205. FUNDING.

Of the amounts authorized to be appropriated to the
Department of Justice, $600,000 shall be available to carry
out this title.

SEC. 206. SUNSET.

The Jewish Refugee Commission shall terminate 60 days after
it submits its report to Congress.
______

By Mr. HARKlN (for himself, Mr. Enzi, Mr. Feingold, Mr. Thomas,
Mr. Dorgan, Mr. Baucus, and Mrs. McCaskill):
S. 622. A bill to enhance fair and open competition in the production
and sale of agricultural commodities; to the Committee on Agriculture,
Nutrition, and Forestry.
Mr. HARKIN. Mr. President, today I am introducing the ``Competitive
and Fair Agricultural Markets Act of 2007.'' Cosponsors joining me in
introducing this legislation are: Senators Enzi, Feingold, Thomas,
Dorgan, Baucus and McCaskill. This legislation seeks to level the
playing field for agricultural producers by strengthening and
clarifying the Packers and Stockyards Act of 1921 and the Agricultural
Fair Practices Act of 1967 and strengthening enforcement of both laws
by USDA. I intend to use this legislation as the basis for developing a
proposed competition title in the new farm bill this year.
Consolidation is happening in all sectors of agriculture and having a
negative effect on producers and consumers across the Nation.
Consolidation in itself is not a violation of the Packers and
Stockyards Act, but when some entities become larger and more powerful
that makes enforcement of the Packers and Stockyards Act absolutely
critical for independent livestock and poultry

[[Page S2053]]

producers. The statistics speak for themselves. For example, today,
only four firms control 84 percent of the procurement of cattle and 64
percent of the procurement of hogs. Economists have stated that when
four firms control over 40 percent of the industry, marketplace
competitiveness begins to decline. Taken together with fewer buyers of
livestock, highly integrated firms can exert tremendous power over the
industry.
The Grain Inspection, Packers and Stockyards Administration, GIPSA,
at USDA has the responsibility to enforce the Packers and Stockyards
Act. This Act is critical, and protects livestock producers from
unfair, unjustly discriminatory and anti-competitive practices in the
marketplace. For years I have had my doubts about whether USDA was
serious about enforcing the Packers and Stockyards Act. In 2005, I
requested an audit by USDA's Inspector General to investigate USDA's
oversight, and enforcement of the law. Last year, the Inspector General
confirmed the concerns I had and uncovered even more systemic problems.
The report described widespread inaction, management of the agency
actively blocking employees from conducting investigations into anti-
competitive behavior and a scheme to cover up the lack of enforcement
by inflating the reported number of investigations conducted.
That is why today, the legislation I introduce will reorganize the
structure in how USDA enforces the Packers and Stockyards Act and
create an office of special counsel on competition matters. The special
counsel would be appointed by the President with advice and consent
from the U.S. Senate. Some would argue that Senate advice and consent
is not needed. However, for over five years, GIPSA failed to move
competition investigations forward and no one above the level of deputy
administrator at GIPSA seemed to have any idea that any problems were
going on, despite the fact I was sending letters to the Secretary of
Agriculture pointing out that USDA was failing to enforce the law.
In the past year, GIPSA has worked in good faith to improve its
enforcement activities. However, GIPSA only investigates potential
violations of the law, they do not litigate and follow-through with the
investigation to the end. Litigating cases is reserved only for USDA's
Office of General Counsel, OGC, unless they refer it to the Department
of Justice.
USDA's Office of General Counsel has not been active on cases
involving anti-competitive practices in recent years since GIPSA was
not referring cases to them. To be sure, only two cases involving anti-
competitive practices were referred to OGC in 5 years. But there are
concerns that OGC is not as committed to enforcing competition
investigations as they should be. This lack of commitment was clearly
evident last year in testimony provided by OGC Assistant General
Counsel in the Trade Practices Division at a hearing by the Senate
Committee on Agriculture, Nutrition, and Forestry.

Concerns about OGC's attitude toward enforcing the Packers and
Stockyards Act are not new. USDA's Inspector General stated in its 1997
audit that Packers and Stockyards program officials were concerned that
OGC did not want to litigate competition cases ``because they are
complicated and time consuming'' and OGC had ``limited expertise'' with
them. In 2000, the Government Accountability Office found
``disagreements'' between OGC and GIPSA regarding the interpretation of
the Act's competition provisions. By combining investigation and
prosecution activities into the proposed special counsel office,
designated to handle competition issues, it reduces the ability for
investigations to be batted back and forth within USDA.
This legislation also makes many important clarifications to the
Packers and Stockyards Act. The Packers and Stockyards Act prohibits
unfair, unjustly discriminatory and anti-competitive practices, but
some courts have ruled that producers need to prove an impact on
competition in the market in order to prevail in such cases involving
unfair or deceptive practices. For example, the United States Eleventh
Circuit Court of Appeals ruled that a poultry grower operation failed
to prove how its case involving an unfair termination of its contract
adversely affected competition. The court indicated that the grower had
to prove that their unfair treatment affected competition in the
relevant market. That is very difficult to prove and was never the
intent of the Packers and Stockyards Act.
This legislation also modifies the Packers and Stockyards Act so that
poultry growers have the same enforcement protections by USDA as
livestock. Currently, it is unlawful for a livestock packer or live
poultry dealer to engage in any unfair, unjustly discriminatory or
deceptive practice, but USDA does not have the authority to enforce
violations because the enforcement section of the law is absent of any
reference to poultry. This important statutory change is long overdue.
In addition, to better reflect the integrated nature of the poultry
industry, this legislation also ensures that protections under the law
extend to all poultry growers, such as breeder hen and pullet
operations, not just those who raise broilers.
The Agricultural Fair Practices Act of 1967 was passed by Congress to
ensure that producers are allowed to join together as an association to
strengthen their position in the marketplace without being
discriminated against by handlers. Unfortunately, this act was passed
with a clause that essentially abolishes the actual intent of the law.
The act states that ``nothing in this Act shall prevent handlers and
producers from selecting their customers'' and it also states that it
does not ``require a handler to deal with an association of
producers.'' This clause in effect allows handlers to think of any
reason possible to not do business with certain producers, as long as
the stated reason is not because they belong to an association.
I propose to expand the Agricultural Fair Practices Act to provide
new needed protections for agricultural contracts. As I have mentioned
earlier, consolidation in all sectors of agriculture is reducing the
number of buyers of commodities and for the very few who are left, many
require contracts to conduct business. With so few buyers, it increases
the chances that some firms will force unfair contracts upon producers.
As a result, some producers have little or no choice but to contract
with a firm with questionable practices or face leaving the industry
they have known for their whole lives.
This amendment to the Agricultural Fair Practices Act requires that
the contract spell out in clear language what is required by the
producer. This legislation prohibits confidentiality clauses, ensuring
producers the ability to share the contract with family members or a
lawyer to help them make an informed decision on whether or not to sign
it. This legislation also prevents companies from prematurely
terminating contracts without notice when producers have made large
capital investments as a condition of signing the contract. And it only
allows mandatory arbitration after a dispute arises and both parties
agree to it in writing. Producers should not be forced to sign
contracts with arbitration clauses thereby preventing them from seeking
legal remedy in the courts.
Mr. President, producers deserve to have a fair and evenhanded market
in which to conduct business. This legislation won't be able to turn
back the clock, but it will strengthen laws and enforcement of them so
that markets operate more fairly.
______

By Mr. SCHUMER (for himself, Mrs. Clinton, Mr. Vitter, Ms.
Collins, Mr. Leahy, and Ms. Stabenow):
S. 623. A bill to amend the Public Health Service Act to provide for
the licensing of comparable and interchangeable biological products,
and for other purposes; to the Committee on Health, Education, Labor,
and Pensions.
Mr. SCHUMER. Mr. President, I rise today to introduce the Access to
Life-Saving Medicine Act with my colleague, Senator Clinton.
Recognizing the promise of generic drugs as safe and effective
treatments at greatly reduced prices, I have worked for years with my
colleagues in the House and the Senate to increase generic drug
availability and accessibility, most notably with Senator McCain on a
2003 law. This legislation represents the next step in the availability
of generic drugs for American consumers by creating a statutory pathway
for generic

[[Page S2054]]

versions of biotech drugs to enter the market.
While generic drugs save American consumers an estimated eight to ten
billion dollars each year, American consumers have not yet reaped the
full potential savings from the generic drug market. Under current law,
there is no generic approval process at the Food and Drug
Administration, FDA, for an entire category of drugs, even once the
patents have expired. These biologic drugs, which are an expensive and
growing sector of the pharmaceutical market, will obtain monopoly
pricing on the market indefinitely without the possibility of generic
competitors.
Drug companies that invest in the research and development of life-
saving drugs, whether biological or chemical in nature, deserve to be
rewarded for their work. At the same time, patients need the ability to
access affordable drugs. We have created a statutory framework for
chemical drugs that balances incentives for continued innovations with
access to affordable drugs for patients. But, this framework has not
yet expanded to biotech drugs, which are on the cutting edge of science
but for which the laws are hopelessly out of date.
Now is the time to ensure that American consumers have the same
access to life-saving biotech drugs that consumers have to well-known,
widely used chemical drugs. Patients need to be able to afford and
access their medications, and they don't care what kind of drug they
have. Patients rely on biotech drugs to treat a wide array of diseases,
ranging from diabetes to cancer to AIDS, but with no generic versions
of biotech drugs available, these drugs can cost tens of thousands of
dollars a year--too expensive for many patients to afford. Introducing
fair competition for biotech drugs is essential to make life-saving
biotech treatments affordable.
The Access to Life-Saving Medicine Act will allow the FDA to approve
generic versions of biologic drugs that have been determined to be both
safe and effective. The FDA is not required to approve any generic
biologics, but if the data is there, they will now have the ability to
do so.
A report released earlier this year by Pharmaceutical Care Management
Association estimated that the introduction of generic biotech drugs
into the market could save Medicare Part B $14 billion over the next
ten years. We need to embrace those potential savings and provide
American consumers access to affordable biotech drugs.
Moving this legislation forward and creating a statutory pathway for
generic versions of biotech drugs to enter the market is one of my
highest priorities in the 110th Congress. I look forward to working
with my colleagues, especially Senator Clinton, to accomplish this
goal.
Mr. President, I ask unanimous consent that the text of the bill be
printed in the Record.
Ms. CLINTON. Mr. President, I am pleased today to join with Senator
Schumer to introduce the Access of Life-Saving Medicine Act. This
legislation will have a dramatic impact on the rising costs of
prescription drugs, which puts the squeeze on employers trying to
provide health coverage for employees while turning a profit, on
families struggling to make ends meet, and on our economy. We spend 16
percent of our national income on health care and prescription drugs
and that number is on the climb.
In 2005, the cost of biologics grew 17.5 percent compared to the cost
of traditional drugs, which increased 10 percent. According to CMS, the
top 2 anemia drugs--both biologics--accounted for 17 percent of all
Medicare Part B carrier drug spending, while two other biologics for
rheumatoid arthritis and cancer accounted for an additional 13 percent.
In 2006, the Medicare Part B program spent more than $5 billion on
biologic drugs.
More than $10 billion worth of biopharmaceuticals will come off
patent in the next 5 years but will continue to cost on-patent prices
unless we act. Our legislation creates a pipeline for approval of safe,
cost effective generic versions of these biologic drugs. Without
action, the manufacturers of these biotech drugs can continue to charge
monopoly prices indefinitely.
This is a perfect example of skyrocketing costs in health care--and a
perfect opportunity to put the brakes on this overspending, which is
bad for patients, businesses, and our country.
According to a report released in January by Engel & Novitt to the
Pharmaceutical Care Management Association, passage of this bill could
save, by conservative estimates, $14 billion over the next 10 years in
Medicare Part B alone.
Scientific advances over the past 20 years have made the
biotechnology industry an integral part of the pharmaceutical industry,
but our health care system has not kept pace. Our laws need to be
updated to reflect the critical role biologics now play in treatment.
The Access to Life-Saving Medicine Act amends the Public Health
Service Act to authorize the FDA to approve abbreviated applications
for biological products that are ``comparable'' to and
``interchangeable'' with previously approved biological products. And
because biological products are very diverse, the Secretary has
discretion on a case-by-case basis to determine what studies are
necessary to establish comparability and interchangeability, and may
require a clinical study or studies if necessary.
To encourage the development of substitutable products, the
legislation gives the first applicant to obtain approval of an
interchangeable product a period of exclusive marketing during which no
other interchangeable version of the product may be approved. In order
to facilitate timely access to these products, an approval may,
however, be granted for a comparable version of the brand name product
if it is not interchangeable.
Finally, to encourage early resolution of patent disputes which might
otherwise delay competition, a patent holder must disclose relevant
patents in response to a request and bring a patent infringement suit
within 45 days of notice of a challenge or lose the right to certain
remedies in court.
Biotech drugs hold great promise, but we break that promise when
costs push treatment out of reach for American families and employers.
We should bring safe, effective and affordable generic versions of
these medicines to patients through passage of the Access to Life-
Saving Medicine Act, saving money and lives.
This issue is part of a larger challenge. It is time to develop a
health care system that reflects and responds to how people are living
today, that addresses the critical problems in cost, quality, and
coverage.
We can use what is right in health care--incredible ingenuity,
leaders at the forefront of medical research, advances in technology,
the best medical professionals in the world--to fix what is wrong.
Smart solutions to the vexing problems plaguing our health care
system will require evidence-based--not ideologically-based--decision
making.
My wonderful predecessor, Senator Moynihan, memorably said,
``Everyone is entitled to his own opinion, but no one is entitled to
his own facts.'' Well, right now, we see a lot of people who have their
own facts that are not based on the evidence.
The fact is, building a pipeline for generic biologics is long
overdue. Achieving this goal is a top priority for me in the HELP
Committee when we consider FDA-related legislation this spring and I
look forward to working with Senator Schumer and my other colleagues to
get it done.
There being no objection, the text of the bill was ordered to be
printed in the Record, as follows:

S. 623

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 ``Access to Life-Saving
Medicine Act''.

SEC. 2. DEFINITIONS.

(a) Amendments.--Section 351(i) of the Public Health
Service Act (42 U.S.C. 262(i)) is amended--
(1) by striking ``In this section, the term `biological
product' means'' and inserting the following: ``In this
section:
``(1) The term `biological product' means''; and
(2) by adding at the end the following:
``(2) The term `abbreviated biological product application'
means an abbreviated application for a license of a
biological product containing the same, or similar, active
ingredient as a reference product.
``(3) The term `reference product' means the single
licensed biological product, approved under subsection (a) or
subsection

[[Page S2055]]

(k), against which a biological product is evaluated for
demonstration of safety, potency, or purity.
``(4) The term `comparable' or `comparability' in reference
to a biological product means the absence of clinically
meaningful differences between the biological product and the
reference product in terms of the safety, purity, and potency
of the product based upon--
``(A) data derived from chemical, physical, and biological
assays, and other non-clinical laboratory studies; and
``(B) data from any necessary clinical study or studies
sufficient to confirm safety, purity, and potency in one or
more appropriate conditions of use for which the reference
product is licensed and intended to be used.

Any studies under subparagraph (B) shall be designed to avoid
duplicative and unethical clinical testing.
``(5) The terms `interchangeable' and `interchangeability'
mean, with respect to the condition of use involved, that the
biological product--
``(A) is comparable to the reference product; and
``(B) can be expected to produce the same clinical result
as the reference product in any given patient.
``(6) The term `thorough characterization' means an
analysis of structural features based upon appropriate
analytical and functional testing sufficient to identify
differences between a biological product and reference
product relevant to safety, purity or potency.
``(7) The term `final action' means, with respect to an
abbreviated biological product application, the Secretary's
issuance of a final action letter to the sponsor of an
abbreviated biological product application which--
``(A) approves the application; or
``(B) disapproves the application and sets forth in detail
an enumeration of the specific deficiencies in the particular
application and of the specific, enumerated actions the
sponsor would be required to take in order for the sponsor to
receive a final action letter that approves such application.
``(8) The term `final action date' means, with respect to
an abbreviated biological product application, the date by
which the Secretary must take a final action on the
application pursuant to subsection (k)(11).
``(9) The term `reviewing division' means the division
responsible for the review of an application for approval of
a biological product (including all scientific and medical
matters, chemistry, manufacturing, and controls).''.
(b) Rule of Construction.--Nothing in this Act or the
amendments made by this Act shall be construed to exclude an
application for licensure of a biological product under
section 351(k) from the definition of a human drug
application in section 735(1)(C) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379g(1)(C)).

SEC. 3. REGULATION OF COMPARABLE AND INTERCHANGEABLE
BIOLOGICAL PRODUCTS.

(a) In General.--Section 351 of the Public Health Service
Act (42 U.S.C. 262) is amended--
(1) in subsection (a)(1)(A), by inserting ``under this
subsection or subsection (k)'' after ``biologics license'';
and
(2) by adding at the end the following subsection:
``(k) Regulation of Comparable and Interchangeable
Biological Products.--
``(1) Submission of an abbreviated biological product
application.--Any person may file with the Secretary an
abbreviated biological product application. Any such
application shall include the following:
``(A) Data demonstrating that the biological product is
comparable to or interchangeable with the reference product.
``(B) Data demonstrating that the biological product and
reference product contain highly similar principal molecular
structural features, notwithstanding minor differences in
heterogeneity profile, impurities, or degradation patterns.
The Secretary shall find the following types of products to
contain highly similar principal molecular structural
features:
``(i) Two protein biological products with differences in
structure between them solely due to post-translational
events, infidelity of translation or transcription, or minor
differences in amino acid sequence.
``(ii) Two polysaccharide biological products with similar
saccharide repeating units, even if the number of units
differ and even if there are differences in post-
polymerization modifications.
``(iii) Two glycosylated protein products with differences
in structure between them solely due to post-translational
events, infidelity of translation or transcription, or minor
differences in amino acid sequence, and if they had similar
saccharide repeating units, even if the number of units
differ and even if there were differences in post-
polymerization modifications.
``(iv) Two polynucleotide biological products with
identical sequence of purine and pyrimidine bases (or their
derivatives) bound to an identical sugar backbone (ribose,
deoxyribose, or modifications of these sugars).
``(v) Closely related, complex partly definable biological
products with similar therapeutic intent, such as two live
viral products for the same indication.

Two biological products not enumerated in the foregoing
clauses may be demonstrated to contain highly similar
principal molecular structural features based upon such data
and other information characterizing the two products as the
Secretary determines to be necessary.
``(C) Data demonstrating that the biological product and
reference product utilize the same mechanism or mechanisms of
action for the condition or conditions of use prescribed,
recommended, or suggested in the proposed labeling, but only
to the extent the mechanism or mechanisms of action are known
for the reference product.
``(D) Information to show that the condition or conditions
of use prescribed, recommended, or suggested in the labeling
proposed for the biological product have been previously
approved for the reference product.
``(E) Information to show that the route of administration,
the dosage form, and the strength of the biological product
are the same as those of the reference product.
``(F) Data demonstrating that the facility in which the
biological product is manufactured, processed, packed, or
held meets standards designed to assure that the biological
product continues to be safe, pure, and potent.
``(G) At the applicant's option, publicly-available
information regarding the Secretary's previous determination
that the reference product is safe, pure, and potent.
``(H) Any additional data and information in support of the
application, including publicly-available information with
respect to the reference product or another biological
product.
``(2) Other applications.--Any person, including a person
who has not conducted and does not have a right of reference
to the studies in the application for a reference product,
may submit an application under this paragraph for a
biological product that differs from, or incorporates a
change to, the reference product with respect to one or more
characteristics described in subparagraphs (A) through (E) of
paragraph (1), including a difference in safety, purity, or
potency, so long as the application contains sufficient
information to establish the safety, purity, and potency of
the biological product relative to the reference product for
its proposed condition or conditions of use.
``(3) FDA review of abbreviated biological product
applications.--
``(A) Guidance regarding review of applications.--The
Secretary shall issue guidance for the individuals who review
applications submitted under paragraph (1) or (2), which
shall relate to promptness in conducting the review,
technical excellence, lack of bias and conflict of interest,
and knowledge of regulatory and scientific standards, and
which shall apply equally to all individuals who review such
applications.
``(B) Meetings with sponsors and applicants.--The Secretary
shall meet with a sponsor of an investigation or an applicant
for approval of a comparable or interchangeable biological
product under this subsection if the sponsor or applicant
makes a reasonable written request for a meeting for the
purpose of reaching agreement on the design and size of
studies needed for approval of the application. The sponsor
or applicant shall provide information necessary for
discussion and agreement on the design and size of such
studies. Minutes of any such meeting shall be prepared by the
Secretary and made available to the sponsor or applicant.
``(C) Agreements.--Any agreement regarding the parameters
of design and size of the studies of a biological product
under this paragraph that is reached between the Secretary
and a sponsor or applicant shall be reduced to writing and
made part of the administrative record by the Secretary. Such
agreement shall not be changed after the testing begins,
except--
``(i) with the written agreement of the sponsor or
applicant; or
``(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of the reviewing division,
that a substantial scientific issue essential to determining
the safety, purity, and potency of the biological product has
been identified after the testing has begun.
``(D) Procedure regarding certain decisions.--A decision
under subparagraph (C)(ii) by the director shall be in
writing and the Secretary shall provide to the sponsor or
applicant an opportunity for a meeting at which the director
and the sponsor or applicant will be present and at which the
director will document the scientific issue involved.
``(E) Effect of decisions.--The written decisions of the
reviewing division shall be binding upon, and may not
directly or indirectly be changed by, the field or compliance
office personnel unless such field or compliance office
personnel demonstrate to the reviewing division why such
decision should be modified.
``(F) Delays by reviewing divisions.--No action by the
reviewing division may be delayed because of the
unavailability of information from or action by field
personnel unless the reviewing division determines that a
delay is necessary to assure the marketing of a safe, pure,
and potent biological product.
``(4) Approval of comparable or interchangeable biological
products.--
``(A) Determination of comparability.--Upon review of an
application submitted under paragraph (1) or (2) for a
biological

[[Page S2056]]

product, the Secretary shall issue a comparable biological
product license for all conditions of use of the reference
product sharing the same mechanism or mechanisms of action
for which the applicant has demonstrated comparability for a
single condition of use, or, if the mechanism or mechanisms
of action are unknown, for the condition or conditions of use
for which the data submitted establishes comparability,
unless the Secretary finds and informs the applicant that--
``(i) information submitted in the application or any other
information available to the Secretary is insufficient to
show that the biological product is comparable to the
reference product for the condition or conditions of use
prescribed, recommended, or suggested in the labeling
proposed in the application;
``(ii) information submitted in the application or any
other information available to the Secretary is insufficient
to show that the biological product and the reference product
contain highly similar principal molecular structural
features, notwithstanding minor differences in heterogeneity
profile, impurities, or degradation patterns;
``(iii) information submitted in the application or any
other information available to the Secretary is insufficient
to show that the biological product and reference product
utilize the same mechanism or mechanisms of action for the
conditions of use prescribed, recommended, or suggested in
the labeling proposed for the biological product, unless the
mechanism or mechanisms of action are not known for the
reference product for such condition or conditions;
``(iv) information submitted in the application or any
other information available to the Secretary is insufficient
to show that the route of administration, the dosage form,
and the strength of the biological product are the same as
those of the reference product;
``(v) information submitted in the application or any other
information available to the Secretary is insufficient to
show that the condition or conditions of use prescribed,
recommended, or suggested in the labeling proposed for the
biological product are limited to one or more of the same use
or uses as have been previously approved for the reference
product;
``(vi) information submitted in the application or any
other information available to the Secretary shows (I) the
inactive ingredients of the biological product are unsafe for
use under the conditions prescribed, recommended, or
suggested in the labeling proposed for the biological
product, or (II) the composition of the biological product is
unsafe under such conditions because of the type or quantity
of inactive ingredients included or the manner in which the
inactive ingredients are included;
``(vii) information submitted in the application or any
other information available to the Secretary fails to
demonstrate that the facility in which the biological product
is manufactured, processed, packed, or held meets standards
designed to assure that the biological product continues to
be safe, pure, and potent;
``(viii) the Secretary has withdrawn or suspended the
license of the reference product, for safety or effectiveness
reasons, or has published a notice of opportunity for hearing
to withdraw such license for safety or effectiveness reasons,
or the Secretary has determined that the reference product
has been withdrawn from sale for safety or effectiveness
reasons; or
``(ix) the application contains an untrue statement of
material fact; and
provides the applicant with a detailed explanation for the
decision.
``(B) Determinations on interchangeability.--Subject to
subparagraph (C) and paragraph (10), upon issuing a product
license for a biological product under subparagraph (A), the
Secretary shall make and publish one of the following
determinations:
``(i) Such product is interchangeable with the reference
product for one or more specified conditions of use
prescribed, recommended, or suggested in the labeling of the
biological product.
``(ii) Interchangeability has not been established.
``(C) Determination of interchangeability of subsequent
biological product.--If the Secretary determines that an
application meets the approval requirements of subparagraph
(A), and, prior to the issuance of a product license, the
Secretary has made a determination of interchangeability of
another biological product and the reference product for
which the exclusivity period under paragraph (10) has not
expired, the Secretary shall--
``(i) issue the product license for the subsequent
biological product; and
``(ii) defer issuing any determination of
interchangeability as to the subsequent biological product
and the reference product until the exclusivity period under
paragraph (10) has expired.
``(5) Postmarketing studies for applications submitted
under paragraph (1).--If the Secretary has agreed with the
sponsor of the reference product, at the time of approval or
any time thereafter, that the sponsor shall conduct one or
more postmarketing safety studies, a person submitting an
application for a biological product under paragraph (1) may
agree with the Secretary to conduct a similar postmarketing
safety study or studies upon a reasonable showing that such
study or studies would provide relevant information not
available from the studies on the reference product. The
Secretary shall not, as a condition of approval, propose any
additional postmarketing studies for such biological product.
``(6) Designation of official name.--If, pursuant to
section 508 of the Federal Food, Drug, and Cosmetic Act, the
Secretary determines that designation of an official name for
a comparable biological product is necessary or desirable in
the interests of usefulness or simplicity, the Secretary
shall designate the same official name for the comparable
biological product as the Secretary designated for the
reference product. This paragraph shall not apply to products
approved under paragraph (7).
``(7) Other approval provisions.--The Secretary shall
approve, under the provisions of paragraph (4)(A), an
application for a license submitted under paragraph (2),
except that the Secretary shall approve such an application
that would otherwise be disapproved by reason of one or more
of subparagraphs (A) through (E) of paragraph (4)(A), if the
application and any other information available to the
Secretary are sufficient to establish the safety, purity, and
potency of the comparable biological product relative to the
reference product for the proposed condition or conditions of
use for such product.
``(8) Establishing interchangeability for comparable
biological products.--
``(A) In general.--In an original application or a
supplement to an application under this subsection, an
applicant may submit information to the Secretary to
demonstrate the interchangeability of a comparable biological
product and the reference product. An applicant may withdraw
an interchangeability submission at any time. A request for
an interchangeability determination submitted after the
filing of an application shall be considered a major
amendment to the application. Nothing in this subsection
shall be construed to prohibit the Secretary from making a
determination of interchangeability at any time after
approval.
``(B) Guidance.--Within one year after enactment of the
Access to Life-Saving Medicine Act, the Secretary shall issue
guidance regarding standards and requirements for
interchangeability. The Secretary may make determinations of
interchangeability under paragraph (4)(B) prior to issuing
guidance under this subparagraph.
``(9) Interchangeability labeling for comparable biological
products.--Upon a determination of interchangeability, the
Secretary, if requested by the applicant, shall provide for
the label of the comparable biological product to include a
statement that the biological product is interchangeable with
the reference product for the conditions of use prescribed,
recommended, or suggested in the labeling for which
interchangeability has been established.
``(10) Exclusivity.--
``(A) In general.--Upon review of an abbreviated biological
product application relying on the same reference product for
which a prior biological product has received a determination
of interchangeability for any condition of use, the Secretary
shall not make a determination under paragraph (4)(B) that
the second or subsequent biological product is
interchangeable for any condition of use, and no holder of a
biological product license approved under subsection (a)
shall manufacture, market, sell, or distribute a rebranded
interchangeable biological product, directly or indirectly,
or authorize any other person to manufacture, market, sell,
or distribute a rebranded interchangeable biological product,
for any condition of use, until the earlier of--
``(i) 180 days after the first commercial marketing of the
first interchangeable comparable biological product to be
approved as interchangeable for that reference product;
``(ii) one year after--

``(I) a final court decision on all patents in suit in an
action instituted under paragraph (17)(C) against the
applicant that submitted the application for the first
approved interchangeable comparable biological product; or
``(II) the dismissal with or without prejudice of an action
instituted under paragraph (17)(C) against the applicant that
submitted the application for the first approved
interchangeable comparable biological product; or

``(iii)(I) 36 months after approval of the first
interchangeable comparable biological product if the
applicant has been sued under paragraph (17)(C) and such
litigation is still ongoing within such 36-month period; or
``(II) one year after approval in the event that the first
approved interchangeable comparable applicant has not been
sued under paragraph (17)(C).

For purposes of this subparagraph, the term `final court
decision' means a final decision of a court from which no
appeal (other than a petition to the United States Supreme
Court for a writ of certiorari) has been or can be taken.
``(B) Rebranded interchangeable biological product.--For
purposes of this subsection, the term `rebranded
interchangeable biological product'--
``(i) means any rebranded interchangeable version of the
reference product involved that the holder of the biological
product license approved under subsection (a) for that
reference product seeks to commence marketing, selling, or
distributing, directly or indirectly; and
``(ii) does not include any product to be marketed, sold,
or distributed--

[[Page S2057]]

``(I) by an entity eligible for exclusivity with respect to
such product under this paragraph; or
``(II) after expiration of any exclusivity with respect to
such product under this paragraph.

``(11) Hearing.--If the Secretary decides to disapprove an
abbreviated biological product application, the Secretary
shall give the applicant notice of an opportunity for a
hearing before the Secretary on the question of whether such
application is approvable. If the applicant elects to accept
the opportunity for hearing by written request within thirty
days after such notice, such hearing shall commence not more
than ninety days after the expiration of such thirty days
unless the Secretary and the applicant otherwise agree. Any
such hearing shall thereafter be conducted on an expedited
basis, and the Secretary's order thereon shall be issued
within ninety days after the date fixed by the Secretary for
filing final briefs.
``(12) Final action date.--
``(A) In general.--The Secretary shall take a final action
on an abbreviated biological product application by the date
that is 8 calendar months following the sponsor's submission
of such application, or 180 days following the Secretary's
notification to the applicant that its application has been
accepted for filing, whichever is earlier.
``(B) Extension.--The final action date provided by
subparagraph (A) with respect to an application may be
extended for such period of time as is agreed to by the
Secretary and the applicant in a jointly executed written
agreement that is counter-signed by the Secretary and the
applicant no later than 30 days prior to such date.
``(13) Request for delay of final action.--Notwithstanding
paragraph (18) or any other provision of law, the Secretary
shall not fail or refuse to take a final action on an
abbreviated biological product application by the final
action date on the basis that a person, other than the
comparable biological product applicant, has requested (in a
petition or otherwise) that the Secretary refuse to take or
otherwise defer such final action, and no court shall enjoin
the Secretary from taking final action or stay the effect of
final action previously taken by the Secretary, except by
issuance of a permanent injunction based upon an express
finding of clear and convincing evidence that the person
seeking to have the Secretary refuse to take or otherwise to
defer final action by the final action date--
``(A) has prevailed on the merits of the person's complaint
against the Secretary;
``(B) will suffer imminent and actual irreparable injury,
constituting more than irrecoverable economic loss, and that
also will threaten imminent destruction of such person's
business; and
``(C) has an interest that outweighs the overwhelming
interest that the public has in obtaining prompt access to a
comparable biological product.
``(14) Report on extensions of final action date.--The
Secretary shall prepare and submit to the President, the
Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education,
Labor, and Pensions of the Senate a report regarding any
jointly executed written agreement to extend the final action
date under this Act within 15 calendar days after the joint
execution of any such written agreement.
``(15) Report on failure to take final action.--The
Secretary shall prepare and submit annually to the President,
the Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education,
Labor, and Pensions of the Senate a report detailing the
specific and particularized reasons enumerated by the
reviewing division for each instance of the Secretary's
failure to take final action by the final action date in the
previous year.
``(16) Regulations.--The Secretary shall establish, by
regulation within 2 years after the date of the enactment of
this subsection, requirements for the efficient review,
approval, suspension, and revocation of abbreviated
biological product applications under this subsection.
``(17) Patents.--
``(A) Request for patent information.--
``(i) In general.--At any time, including at the initial
stages of development, an applicant or a prospective
applicant under this subsection may send a written request
for patent information to the holder of the approved
application for the reference product. The holder of the
approved application for the reference product shall, not
later than 60 days after the date on which the holder
receives the request, provide to the applicant or prospective
applicant a list of all those patents owned by, or licensed
to, the holder of the approved application that the holder
believes in good faith relate to the reference product,
including patents that claim the approved biological product,
any method of using such product, any component of such
product, or any method or process of manufacturing such
product or component.
``(ii) Costs of complying with request.--The application
holder may demand payment of not more than $1,000 to offset
the cost of responding to the request for information.
``(iii) Updates.--For a period of two years beginning on
the date on which the holder of the approved application for
the reference product receives the request for information,
the holder shall send to the applicant or prospective
applicant updates of its response to the request for
information by identifying all relevant patents issued or
licensed to the holder after the initial response under
clause (i). Any such update must be provided, in the case of
a new patent, not later than 30 days after the date on which
the patent is issued and, in the case of a license, not later
than 30 days after the date on which the holder obtains the
license.
``(iv) Additional requests.--The applicant may submit
additional requests for patent information, subject to the
requirements of this paragraph, at any time.
``(B) Patent notifications.--At any time after submitting
an application under this subsection, the applicant may
provide a notice of the application with respect to any one
or more patents identified by the holder of the reference
product pursuant to subparagraph (A). An applicant may submit
additional notices at any time, and each notice shall be
subject to the provisions of this subparagraph. Each notice
shall--
``(i) be sent to the holder of the approved application for
the reference product and to the owner of any patent
identified by the holder pursuant to subparagraph (A);
``(ii) include a detailed statement of the factual and
legal bases for the applicant's belief that the patents
included in the notice are invalid, are unenforceable, or
will not be infringed by the commercial sale of the product
for which approval is being sought under this subsection; and
``(iii) identify 1 or more judicial districts in which the
applicant consents to such suit being brought.
``(C) Action for infringement.--Within 45 days after the
date on which the holder of the approved application for the
reference product, or the owner of a patent, receives a
notice under subparagraph (B), the holder or patent owner may
bring an action for infringement only with respect to the
patent or patents included in the notice, and only in a
judicial district identified pursuant to subparagraph
(B)(iii).
``(D) Limitation on declaratory judgment actions.--With
respect to any patent relating to a product that is the
subject of an application under this subsection, the
recipient of a notice under subparagraph (B) with respect to
that application may not, prior to the commercial marketing
of the product, bring any action under section 2201 of title
28, United States Code, for a declaration of infringement,
validity, or enforceability of any such patent that was not
identified in the notice. With respect to any such patent
identified in the notice, any such action may,
notwithstanding chapter 87 of title 28, United States Code,
be brought only in a judicial district identified in the
notice.
``(E) Discretion of applicants.--An applicant or
prospective applicant for a comparable biological product
under this subsection may not be compelled, by court order or
otherwise, to initiate the procedures set forth in this
paragraph. Nothing in this paragraph requires an applicant or
a prospective applicant to invoke the procedures set forth in
this paragraph.
``(18) Petitions and civil actions regarding approval of
certain applications.--
``(A) In general.--With respect to a pending application
submitted under paragraph (1) or (2), if a petition is
submitted to the Secretary that seeks to have the Secretary
take, or refrain from taking, any form of action relating to
the approval of the application, including a delay in the
effective date of the application, the following applies,
subject to subparagraph (E):
``(i)(I) The Secretary may not, on the basis of the
petition, delay approval of the application unless the
Secretary determines, within 30 days after receiving the
petition, that a delay is necessary to protect the public
health. Consideration of a petition shall be separate and
apart from the review and approval of the application.
``(II) With respect to a determination by the Secretary
under subclause (I) that a delay is necessary to protect the
public health:

``(aa) The Secretary shall publish on the Internet site of
the Food and Drug Administration a statement providing the
reasons underlying the determination.
``(bb) Not later than 10 days after making the
determination, the Secretary shall provide notice to the
sponsor of the application and an opportunity for a meeting
with the Commissioner to discuss the determination.

``(ii) The Secretary shall take final agency action on the
petition not later than 180 days after the date on which the
petition is submitted. The Secretary shall not extend such
period, even with the consent of the petitioner, for any
reason, including based upon the submission of comments
relating to the petition or supplemental information supplied
by the petitioner.
``(iii) The Secretary may not consider the petition for
review unless it is signed and contains the following
verification: `I certify that, to my best knowledge and
belief: (a) this petition includes all information and views
upon which the petition relies; (b) this petition includes
representative data and/or information known to the
petitioner which are unfavorable to the petition; and (c) I
have taken reasonable steps to ensure that any representative
data and/or information which are unfavorable to the petition
were disclosed to me. I further certify that the information
upon which I have based the action requested herein first
became known to the party on whose behalf this petition is
submitted on or about the following date: _______. I received
or expect to receive payments, including cash and other forms
of

[[Page S2058]]

consideration, from the following persons or organizations to
file this petition: ________. I verify under penalty of
perjury that the foregoing is true and correct.'.
``(B) Exhaustion of administrative remedies.--
``(i) Final agency action within 180 days.--The Secretary
shall be considered to have taken final agency action on a
petition referred to in subparagraph (A) if--

``(I) during the 180-day period referred to in clause (ii)
of such subparagraph, the Secretary makes a final decision
within the meaning of section 10.45(d) of title 21, Code of
Federal Regulations (or any successor regulations); or
``(II) such period expires without the Secretary having
made such a final decision.

``(ii) Dismissal of certain civil actions.--If a civil
action is filed with respect to a petition referred to in
subparagraph (A) before final agency action within the
meaning of clause (i) has occurred, the court shall dismiss
the action for failure to exhaust administrative remedies.
``(C) Applicability of certain regulations.--The provisions
of this section are in addition to the requirements for the
submission of a petition to the Secretary that apply under
section 10.30 or 10.35 of title 21, Code of Federal
Regulations (or any successor regulations).
``(D) Annual report on delays in approvals per petitions.--
The Secretary shall annually submit to the Congress a report
that specifies--
``(i) the number of applications under this subsection that
were approved during the preceding 12-month period;
``(ii) the number of such applications whose effective
dates were delayed by petitions referred to in subparagraph
(A) during such period; and
``(iii) the number of days by which the applications were
so delayed.
``(E) Exception.--This paragraph does not apply to a
petition that is made by the sponsor of an application under
this subsection and that seeks only to have the Secretary
take or refrain from taking any form of action with respect
to that application.
``(F) Definition.--For purposes of this paragraph, the term
`petition' includes any request to the Secretary, without
regard to whether the request is characterized as a
petition.''.
(b) Additional Amendments.--
(1) Patents.--Section 271(e) of title 35, United States
Code, is amended--
(A) in paragraph (2)--
(i) by striking ``or'' at the end of subparagraph (A);
(ii) by adding ``or'' at the end of subparagraph (B);
(iii) by inserting after subparagraph (B) the following:
``(C) a notice described in section 351(k)(17)(B) of the
Public Health Service Act, but only with respect to a patent
identified in such notice,''; and
(iv) in the matter following subparagraph (C) (as inserted
by clause (iii) of this subparagraph), by inserting before
the period the following: ``, or if the notice described in
subparagraph (C) is provided in connection with an
application to obtain a license to engage in the commercial
manufacture, use, or sale of a biological product claimed in
a patent or the use of which is claimed in a patent before
the expiration of such patent''; and
(B) by adding at the end the following paragraph:
``(6)(A) This paragraph applies, in lieu of paragraph (4),
in the case of a patent--
``(i) which is disclosed in a response to a request for
patent information pursuant to subparagraph (A) of section
351(k)(17) of the Public Health Service Act;
``(ii) with respect to which a notice was provided pursuant
to subparagraph (B) of such section; and
``(iii) for which an action for infringement of the
patent--
``(I) was brought after the expiration of the 45-day period
described in subparagraph (C) of such section; or
``(II) was brought before the expiration of the 45-day
period described in subclause (I), but which was dismissed
without prejudice or was not prosecuted to judgment in good
faith.
``(B) In an action for infringement of a patent described
in subparagraph (A), the sole and exclusive remedy that may
be granted by a court, upon a finding that the person who
submitted the notice described in subparagraph (A)(ii)
infringed the patent, or that any person induced or
contributed to infringement of the patent, shall be a
reasonable royalty.
``(C) The owner of a patent that should have been disclosed
in response to a request for patent information made by an
applicant pursuant to subparagraph (A)(i) of section
351(k)(17) of the Public Health Service Act, but that was not
timely disclosed under that subparagraph, may not bring an
action under this section for infringement of that patent.''.
(2) Conforming amendments.--
(A) Title 28.--Section 2201(b) of title 28, United States
Code, is amended by inserting before the period the
following: ``, or section 351 of the Public Health Service
Act''.
(B) Public health service act.--Subjection (j) of section
351 of the Public Health Service Act (42 U.S.C. 262) is
amended by inserting ``or subsection (k)'' after ``subsection
(a)''.
______

By Mr. KENNEDY (for himself, Mr. Cornyn, Mr. Harkin, Mr. McCain,
Mr. Durbin, Mr. Lugar, Mr. Dodd, Mr. Smith, Mr. Reed, Ms.
Snowe, Mr. Lautenberg, Ms. Murkowski, Mr. Bingaman, Ms.
Collins, Ms. Mikulski, Mr. Stevens, Mrs. Murray, Mr. Domenici,
Mrs. Clinton, Mr. Cochran, Mrs. Feinstein, Mr. Leahy, Mr.
Obama, Mr. Sanders, Mr. Brown, Mr. Schumer, Mr. Akaka, Mr.
Kohl, Ms. Cantwell, Mr. Carper, and Mr. Nelson of Florida):
S. 625. A bill to protect the public health by providing the Food and
Drug Administration with certain authority to regulate tobacco
products; to the Committee on Health, Education, Labor, and Pensions.
Mr. KENNEDY. Mr. President, today, we are introducing legislation to
give the Food and Drug Administration broad authority to regulate
tobacco products. Congress cannot in good conscience allow the Federal
agency most responsible for protecting the public health to remain
powerless to deal with the enormous risks of tobacco, the most deadly
of all consumer products. Health experts believe this legislation is
the most important action Congress could take to protect children from
this deadly addiction.
This is a bipartisan, bicameral initiative. The bill that Senator
Cornyn and I are introducing already has over 25 cosponsors.
Congressman Waxman and Davis will introduce identical legislation in
the House. Our bill has the support of a broad coalition of public
health organizations led by the Campaign for Tobacco-Free Kids, the
American Cancer Society, the American Heart Association and the
American Lung Association. They all recognize the importance of
enacting this bill this year.
The legislation we are introducing today is well known. It is the
same bill that passed the Senate in 2004, and that we introduced in the
last Congress. However, in this new Congress, the likelihood of passage
is greatly enhanced. Last November's election swept away many of the
barriers to passage from prior years. We believe 2007 is the year that
legislation empowering the FDA to regulate tobacco products will
finally become law.
We intend to move forward on the legislation quickly. I have already
scheduled a hearing in the HELP Committee for February 27, and a markup
is planned soon thereafter.
The stakes are vast. Four thousand children have their first
cigarette every day, and one thousand become daily smokers. More than
one-third of them will die prematurely from tobacco-induced diseases.
Cigarettes kill well over 400,000 Americans each year. That is more
lives lost than from automobile accidents, alcohol abuse, illegal
drugs, AIDS, murder, and suicide combined. Congress's response to a
public health problem of this magnitude is long overdue.
Regulating the conduct of tobacco companies is as necessary today as
it has been in years past. The facts presented in the Federal
Government's landmark lawsuit against the tobacco industry demonstrate
that the misconduct is substantial and ongoing. The decision of the
court states: ``The evidence in this case clearly establishes that
Defendants have not ceased engaging in unlawful activity . . .
Defendants continue to engage in conduct that is materially
indistinguishable from their previous actions, activity that continues
to this day.''
We must deal firmly with tobacco company marketing practices that
target children and mislead the public. The Food and Drug
Administration needs broad authority to regulate the sale,
distribution, and advertising of cigarettes and smokeless tobacco.
The tobacco industry currently spends over $15 billion a year to
promote its products. Much of that money is spent in ways designed to
tempt children to start smoking, before they are mature enough to
appreciate the enormity of the health risk. The industry knows that
nearly 90 percent of smokers begin as children and are addicted by the
time they reach adulthood.
Documents obtained from tobacco companies prove, in the companies'
own words, the magnitude of the industry's efforts to trap children
into dependency on their deadly product. Studies by the Institute of
Medicine and the Centers for Disease Control show the substantial role
of industry

[[Page S2059]]

advertising in decisions by young people to use tobacco products.
If we are serious about reducing youth smoking, FDA must have the
power to prevent industry advertising designed to appeal to children
wherever it will be seen by children. This legislation will give FDA
the authority to stop tobacco advertising that glamorizes smoking to
kids. It grants FDA full authority to regulate tobacco advertising
``consistent with and to the full extent permitted by the First
Amendment.''
FDA authority must also extend to the sale of tobacco products.
Nearly every State makes it illegal to sell cigarettes to children
under 18, but surveys show that those laws are rarely enforced and
frequently violated. FDA must have the power to limit the sale of
cigarettes to face-to-face transactions in which the age of the
purchaser can be verified by identification. This means an end to self-
service displays and vending machine sales. There must also be serious
enforcement efforts with real penalties for those caught selling
tobacco products to children. This is the only way to ensure that
children under 18 are not able to buy cigarettes.

The FDA conducted the longest rulemaking proceeding in its history,
studying which regulations would most effectively reduce the number of
children who smoke. Seven hundred thousand public comments were
received in the course of that rulemaking. At the conclusion of its
proceeding, the agency promulgated rules on the manner in which
cigarettes are advertised and sold. Due to litigation, most of those
regulations were never implemented. If we are serious about curbing
youth smoking as much as possible, as soon as possible; it makes no
sense to require FDA to reinvent the wheel by conducting a new multi-
year rulemaking process on the same issues. This legislation will give
the youth access and advertising restrictions already developed by FDA
the immediate force of law, as if they had been issued under the new
statute.
The legislation also provides for stronger warnings on all cigarette
and smokeless tobacco packages, and in all print advertisements. These
warnings will be more explicit in their description of the medical
problems which can result from tobacco use. The FDA is given the
authority to change the text of these warning labels periodically, to
keep their impact strong.
The nicotine in cigarettes is highly addictive. Medical experts say
that it is as addictive as heroin or cocaine. Yet for decades, tobacco
companies vehemently denied the addictiveness of their products. No one
can forget the parade of tobacco executives who testified under oath
before Congress that smoking cigarettes is not addictive. Overwhelming
evidence in industry documents obtained through the discovery process
proves that the companies not only knew of this addictiveness for
decades, but actually relied on it as the basis for their marketing
strategy. As we now know, cigarette manufacturers chemically
manipulated the nicotine in their products to make it even more
addictive.
A newly released analysis by the Harvard School of Public Health
demonstrates that cigarette manufacturers are still manipulating
nicotine levels. Between 1998 and 2005, they significantly increased
the nicotine yield from major brand name cigarettes. The average
increase in nicotine yield over the period was 11 percent.
The tobacco industry has a long, dishonorable history of providing
misleading information about the health consequences of smoking. These
companies have repeatedly sought to characterize their products as far
less hazardous than they are. They made minor innovations in product
design seem far more significant for the health of the user than they
actually were. It is essential that FDA have clear and unambiguous
authority to prevent such misrepresentations in the future. The largest
disinformation campaign in the history of the corporate world must end.
Given the addictiveness of tobacco products, it is essential that the
FDA regulate them for the protection of the public. Over 40 million
Americans are currently addicted to cigarettes. No responsible public
health official believes that cigarettes should be banned. A ban would
leave 40 million people without a way to satisfy their drug dependency.
FDA should be able to take the necessary steps to help addicted smokers
overcome their addiction, and to make the product less toxic for
smokers who are unable or unwilling to stop. To do so, FDA must have
the authority to reduce or remove hazardous ingredients from
cigarettes, to the extent that it becomes scientifically feasible. The
inherent risk in smoking should not be unnecessarily compounded.
Recent statements by several tobacco companies make clear that they
plan to develop what they characterize as ``reduced risk'' cigarettes.
Some are already on the market making unsubstantiated claims. This
legislation will require manufacturers to submit such ``reduced risk''
products to the FDA for analysis before they can be marketed. No
health-related claims will be permitted until they have been verified
to the FDA's satisfaction. These safeguards are essential to prevent
deceptive industry marketing campaigns, which could lull the public
into a false sense of health safety.
Smoking is the number one preventable cause of death in America.
Congress must vest FDA not only with the responsibility for regulating
tobacco products, but with full authority to do the job effectively.
This legislation will give the FDA the legal authority it needs to
reduce youth smoking by preventing tobacco advertising which targets
children, to prevent the sale of tobacco products to minors, to help
smokers overcome their addiction, to make tobacco products less toxic
for those who continue to use them, and to prevent the tobacco industry
from misleading the public about the dangers of smoking.
Enacting this bill this year is the right thing to do for America's
children. They are depending on us. By passing this legislation, we can
help them live longer, healthier lives.
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. 625

Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title.--This Act may be cited as the ``Family
Smoking Prevention and Tobacco Control Act''.
(b) Table of Contents.--The table of contents of this Act
is as follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.
Sec. 5. Severability.

TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION

Sec. 101. Amendment of Federal food, drug, and Cosmetic Act.
Sec. 102. Final rule.
Sec. 103. Conforming and other amendments to general provisions.

TITLE II--TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT
DISCLOSURE

Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Authority to revise cigarette warning label statements.
Sec. 203. State regulation of cigarette advertising and promotion.
Sec. 204. Smokeless Tobacco labels and advertising warnings.
Sec. 205. Authority to revise Smokeless Tobacco product warning label
statements.
Sec. 206. Tar, Nicotine, and other smoke constituent disclosure to the
public.

TITLE III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS

Sec. 301. Labeling, recordkeeping, records inspection.
Sec. 302. Study and report.

SEC. 2. FINDINGS.

The Congress finds the following:
(1) The use of tobacco products by the Nation's children is
a pediatric disease of considerable proportions that results
in new generations of tobacco-dependent children and adults.
(2) A consensus exists within the scientific and medical
communities that tobacco products are inherently dangerous
and cause cancer, heart disease, and other serious adverse
health effects.
(3) Nicotine is an addictive drug.
(4) Virtually all new users of tobacco products are under
the minimum legal age to purchase such products.
(5) Tobacco advertising and marketing contribute
significantly to the use of nicotine-containing tobacco
products by adolescents.
(6) Because past efforts to restrict advertising and
marketing of tobacco products

[[Page S2060]]

have failed adequately to curb tobacco use by adolescents,
comprehensive restrictions on the sale, promotion, and
distribution of such products are needed.
(7) Federal and State governments have lacked the legal and
regulatory authority and resources they need to address
comprehensively the public health and societal problems
caused by the use of tobacco products.
(8) Federal and State public health officials, the public
health community, and the public at large recognize that the
tobacco industry should be subject to ongoing oversight.
(9) Under article I, section 8 of the Constitution, the
Congress is vested with the responsibility for regulating
interstate commerce and commerce with Indian tribes.
(10) The sale, distribution, marketing, advertising, and
use of tobacco products are activities in and substantially
affecting interstate commerce because they are sold,
marketed, advertised, and distributed in interstate commerce
on a nationwide basis, and have a substantial effect on the
Nation's economy.
(11) The sale, distribution, marketing, advertising, and
use of such products substantially affect interstate commerce
through the health care and other costs attributable to the
use of tobacco products.
(12) It is in the public interest for Congress to enact
legislation that provides the Food and Drug Administration
with the authority to regulate tobacco products and the
advertising and promotion of such products. The benefits to
the American people from enacting such legislation would be
significant in human and economic terms.
(13) Tobacco use is the foremost preventable cause of
premature death in America. It causes over 400,000 deaths in
the United States each year and approximately 8,600,000
Americans have chronic illnesses related to smoking.
(14) Reducing the use of tobacco by minors by 50 percent
would prevent well over 10,000,000 of today's children from
becoming regular, daily smokers, saving over 3,000,000 of
them from premature death due to tobacco induced disease.
Such a reduction in youth smoking would also result in
approximately $75,000,000,000 in savings attributable to
reduced health care costs.
(15) Advertising, marketing, and promotion of tobacco
products have been especially directed to attract young
persons to use tobacco products and these efforts have
resulted in increased use of such products by youth. Past
efforts to oversee these activities have not been successful
in adequately preventing such increased use.
(16) In 2003, the cigarette manufacturers spent more than
$15,000,000,000 to attract new users, retain current users,
increase current consumption, and generate favorable long-
term attitudes toward smoking and tobacco use.
(17) Tobacco product advertising often misleadingly
portrays the use of tobacco as socially acceptable and
healthful to minors.
(18) Tobacco product advertising is regularly seen by
persons under the age of 18, and persons under the age of 18
are regularly exposed to tobacco product promotional efforts.
(19) Through advertisements during and sponsorship of
sporting events, tobacco has become strongly associated with
sports and has become portrayed as an integral part of sports
and the healthy lifestyle associated with rigorous sporting
activity.
(20) Children are exposed to substantial and unavoidable
tobacco advertising that leads to favorable beliefs about
tobacco use, plays a role in leading young people to
overestimate the prevalence of tobacco use, and increases the
number of young people who begin to use tobacco.
(21) The use of tobacco products in motion pictures and
other mass media glamorizes its use for young people and
encourages them to use tobacco products.
(22) Tobacco advertising expands the size of the tobacco
market by increasing consumption of tobacco products
including tobacco use by young people.
(23) Children are more influenced by tobacco marketing than
adults: more than 80 percent of youth smoke three heavily
marketed brands, while only 54 percent of adults, 26 and
older, smoke these same brands.
(24) Tobacco company documents indicate that young people
are an important and often crucial segment of the tobacco
market. Children, who tend to be more price-sensitive than
adults, are influenced by advertising and promotion practices
that result in drastically reduced cigarette prices.
(25) Comprehensive advertising restrictions will have a
positive effect on the smoking rates of young people.
(26) Restrictions on advertising are necessary to prevent
unrestricted tobacco advertising from undermining legislation
prohibiting access to young people and providing for
education about tobacco use.
(27) International experience shows that advertising
regulations that are stringent and comprehensive have a
greater impact on overall tobacco use and young people's use
than weaker or less comprehensive ones.
(28) Text only requirements, although not as stringent as a
ban, will help reduce underage use of tobacco products while
preserving the informational function of advertising.
(29) It is in the public interest for Congress to adopt
legislation to address the public health crisis created by
actions of the tobacco industry.
(30) The final regulations promulgated by the Secretary of
Health and Human Services in the August 28, 1996, issue of
the Federal Register (61 Fed. Reg. 44615-44618) for inclusion
as part 897 of title 21, Code of Federal Regulations, are
consistent with the First Amendment to the United States
Constitution and with the standards set forth in the
amendments made by this subtitle for the regulation of
tobacco products by the Food and Drug Administration and the
restriction on the sale and distribution, including access to
and the advertising and promotion of, tobacco products
contained in such regulations are substantially related to
accomplishing the public health goals of this Act.
(31) The regulations described in paragraph (30) will
directly and materially advance the Federal Government's
substantial interest in reducing the number of children and
adolescents who use cigarettes and smokeless tobacco and in
preventing the life-threatening health consequences
associated with tobacco use. An overwhelming majority of
Americans who use tobacco products begin using such products
while they are minors and become addicted to the nicotine in
those products before reaching the age of 18. Tobacco
advertising and promotion plays a crucial role in the
decision of these minors to begin using tobacco products.
Less restrictive and less comprehensive approaches have not
and will not be effective in reducing the problems addressed
by such regulations. The reasonable restrictions on the
advertising and promotion of tobacco products contained in
such regulations will lead to a significant decrease in the
number of minors using and becoming addicted to those
products.
(32) The regulations described in paragraph (30) impose no
more extensive restrictions on communication by tobacco
manufacturers and sellers than are necessary to reduce the
number of children and adolescents who use cigarettes and
smokeless tobacco and to prevent the life-threatening health
consequences associated with tobacco use. Such regulations
are narrowly tailored to restrict those advertising and
promotional practices which are most likely to be seen or
heard by youth and most likely to entice them into tobacco
use, while affording tobacco manufacturers and sellers ample
opportunity to convey information about their products to
adult consumers.
(33) Tobacco dependence is a chronic disease, one that
typically requires repeated interventions to achieve long-
term or permanent abstinence.
(34) Because the only known safe alternative to smoking is
cessation, interventions should target all smokers to help
them quit completely.
(35) Tobacco products have been used to facilitate and
finance criminal activities both domestically and
internationally. Illicit trade of tobacco products has been
linked to organized crime and terrorist groups.
(36) It is essential that the Food and Drug Administration
review products sold or distributed for use to reduce risks
or exposures associated with tobacco products and that it be
empowered to review any advertising and labeling for such
products. It is also essential that manufacturers, prior to
marketing such products, be required to demonstrate that such
products will meet a series of rigorous criteria, and will
benefit the health of the population as a whole, taking into
account both users of tobacco products and persons who do not
currently use tobacco products.
(37) Unless tobacco products that purport to reduce the
risks to the public of tobacco use actually reduce such
risks, those products can cause substantial harm to the
public health to the extent that the individuals, who would
otherwise not consume tobacco products or would consume such
products less, use tobacco products purporting to reduce
risk. Those who use products sold or distributed as modified
risk products that do not in fact reduce risk, rather than
quitting or reducing their use of tobacco products, have a
substantially increased likelihood of suffering disability
and premature death. The costs to society of the widespread
use of products sold or distributed as modified risk products
that do not in fact reduce risk or that increase risk include
thousands of unnecessary deaths and injuries and huge costs
to our health care system.
(38) As the National Cancer Institute has found, many
smokers mistakenly believe that ``low tar'' and ``light''
cigarettes cause fewer health problems than other cigarettes.
As the National Cancer Institute has also found, mistaken
beliefs about the health consequences of smoking ``low tar''
and ``light'' cigarettes can reduce the motivation to quit
smoking entirely and thereby lead to disease and death.
(39) Recent studies have demonstrated that there has been
no reduction in risk on a population-wide basis from ``low
tar'' and ``light'' cigarettes and such products may actually
increase the risk of tobacco use.
(40) The dangers of products sold or distributed as
modified risk tobacco products that do not in fact reduce
risk are so high that there is a compelling governmental
interest in insuring that statements about modified risk
tobacco products are complete, accurate, and relate to the
overall disease risk of the product.
(41) As the Federal Trade Commission has found, consumers
have misinterpreted advertisements in which one product is
claimed to be less harmful than a comparable product, even in
the presence of disclosures and advisories intended to
provide clarification.

[[Page S2061]]

(42) Permitting manufacturers to make unsubstantiated
statements concerning modified risk tobacco products, whether
express or implied, even if accompanied by disclaimers would
be detrimental to the public health.
(43) The only way to effectively protect the public health
from the dangers of unsubstantiated modified risk tobacco
products is to empower the Food and Drug Administration to
require that products that tobacco manufacturers sold or
distributed for risk reduction be approved in advance of
marketing, and to require that the evidence relied on to
support approval of these products is rigorous.

SEC. 3. PURPOSE.

The purposes of this Act are--
(1) to provide authority to the Food and Drug
Administration to regulate tobacco products under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), by
recognizing it as the primary Federal regulatory authority
with respect to the manufacture, marketing, and distribution
of tobacco products;
(2) to ensure that the Food and Drug Administration has the
authority to address issues of particular concern to public
health officials, especially the use of tobacco by young
people and dependence on tobacco;
(3) to authorize the Food and Drug Administration to set
national standards controlling the manufacture of tobacco
products and the identity, public disclosure, and amount of
ingredients used in such products;
(4) to provide new and flexible enforcement authority to
ensure that there is effective oversight of the tobacco
industry's efforts to develop, introduce, and promote less
harmful tobacco products;
(5) to vest the Food and Drug Administration with the
authority to regulate the levels of tar, nicotine, and other
harmful components of tobacco products;
(6) in order to ensure that consumers are better informed,
to require tobacco product manufacturers to disclose research
which has not previously been made available, as well as
research generated in the future, relating to the health and
dependency effects or safety of tobacco products;
(7) to continue to permit the sale of tobacco products to
adults in conjunction with measures to ensure that they are
not sold or accessible to underage purchasers;
(8) to impose appropriate regulatory controls on the
tobacco industry;
(9) to promote cessation to reduce disease risk and the
social costs associated with tobacco related diseases; and
(10) to strengthen legislation against illicit trade in
tobacco products.

SEC. 4. SCOPE AND EFFECT.

(a) Intended Effect.--Nothing in this Act (or an amendment
made by this Act) shall be construed to--
(1) establish a precedent with regard to any other
industry, situation, circumstance, or legal action; or
(2) affect any action pending in Federal, State, or Tribal
court, or any agreement, consent decree, or contract of any
kind.
(b) Agricultural Activities.--The provisions of this Act
(or an amendment made by this Act) which authorize the
Secretary to take certain actions with regard to tobacco and
tobacco products shall not be construed to affect any
authority of the Secretary of Agriculture under existing law
regarding the growing, cultivation, or curing of raw tobacco.

SEC. 5. SEVERABILITY.

If any provision of this Act, the amendments made by this
Act, or the application of any provision of this Act to any
person or circumstance is held to be invalid, the remainder
of this Act, the amendments made by this Act, and the
application of the provisions of this Act to any other person
or circumstance shall not be affected and shall continue to
be enforced to the fullest extent possible.

TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION

SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.

(a) Definition of Tobacco Products.--Section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is
amended by adding at the end the following:
``(rr)(1) The term `tobacco product' means any product made
or derived from tobacco that is intended for human
consumption, including any component, part, or accessory of a
tobacco product (except for raw materials other than tobacco
used in manufacturing a component, part, or accessory of a
tobacco product).
``(2) The term `tobacco product' does not mean--
``(A) a product in the form of conventional food (including
water and chewing gum), a product represented for use as or
for use in a conventional food, or a product that is intended
for ingestion in capsule, tablet, softgel, or liquid form; or
``(B) an article that is approved or is regulated as a drug
by the Food and Drug Administration.
``(3) The products described in paragraph (2)(A) shall be
subject to chapter IV or chapter V of this Act and the
articles described in paragraph (2)(B) shall be subject to
chapter V of this Act.
``(4) A tobacco product may not be marketed in combination
with any other article or product regulated under this Act
(including a drug, biologic, food, cosmetics, medical device,
or a dietary supplement).''.
(b) FDA Authority Over Tobacco Products.--The Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
(1) by redesignating chapter IX as chapter X;
(2) by redesignating sections 901 through 909 as sections
1001 through 1009;
(3) in section 1009 (as so redesignated), by striking
``section 908'' and inserting ``section 1008''; and
(4) by inserting after chapter VIII the following:

``CHAPTER IX--TOBACCO PRODUCTS

``SEC. 900. DEFINITIONS.

``In this chapter:
``(1) Additive.--The term `additive' means any substance
the intended use of which results or may reasonably be
expected to result, directly or indirectly, in its becoming a
component or otherwise affecting the characteristic of any
tobacco product (including any substances intended for use as
a flavoring, coloring or in producing, manufacturing,
packing, processing, preparing, treating, packaging,
transporting, or holding), except that such term does not
include tobacco or a pesticide chemical residue in or on raw
tobacco or a pesticide chemical.
``(2) Brand.--The term `brand' means a variety of tobacco
product distinguished by the tobacco used, tar content,
nicotine content, flavoring used, size, filtration, or
packaging, logo, registered trademark or brand name,
identifiable pattern of colors, or any combination of such
attributes.
``(3) Cigarette.--The term `cigarette' has the meaning
given that term by section 3(1) of the Federal Cigarette
Labeling and Advertising Act, but also includes tobacco, in
any form, that is functional in the product, which, because
of its appearance, the type of tobacco used in the filler, or
its packaging and labeling, is likely to be offered to, or
purchased by, consumers as a cigarette or as roll-your-own
tobacco.
``(4) Cigarette tobacco.--The term `cigarette tobacco'
means any product that consists of loose tobacco that is
intended for use by consumers in a cigarette. Unless
otherwise stated, the requirements for cigarettes shall also
apply to cigarette tobacco.
``(5) Commerce.--The term `commerce' has the meaning given
that term by section 3(2) of the Federal Cigarette Labeling
and Advertising Act.
``(6) Counterfeit tobacco product.--The term `counterfeit
tobacco product' means a tobacco product (or the container or
labeling of such a product) that, without authorization,
bears the trademark, trade name, or other identifying mark,
imprint or device, or any likeness thereof, of a tobacco
product listed in a registration under section 905(i)(1).
``(7) Distributor.--The term `distributor' as regards a
tobacco product means any person who furthers the
distribution of a tobacco product, whether domestic or
imported, at any point from the original place of manufacture
to the person who sells or distributes the product to
individuals for personal consumption. Common carriers are not
considered distributors for purposes of this chapter.
``(8) Illicit trade.--The term `illicit trade' means any
practice or conduct prohibited by law which relates to
production, shipment, receipt, possession, distribution,
sale, or purchase of tobacco products including any practice
or conduct intended to facilitate such activity.
``(9) Indian tribe.--The term `Indian tribe' has the
meaning given such term in section 4(e) of the Indian Self
Determination and Education Assistance Act.
``(10) Little cigar.--The term `little cigar' has the
meaning given that term by section 3(7) of the Federal
Cigarette Labeling and Advertising Act.
``(11) Nicotine.--The term `nicotine' means the chemical
substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or
C[10]H[14]N[2], including any salt or complex of nicotine.
``(12) Package.--The term `package' means a pack, box,
carton, or container of any kind or, if no other container,
any wrapping (including cellophane), in which a tobacco
product is offered for sale, sold, or otherwise distributed
to consumers.
``(13) Retailer.--The term `retailer' means any person who
sells tobacco products to individuals for personal
consumption, or who operates a facility where self-service
displays of tobacco products are permitted.
``(14) Roll-your-own tobacco.--The term `roll-your-own
tobacco' means any tobacco which, because of its appearance,
type, packaging, or labeling, is suitable for use and likely
to be offered to, or purchased by, consumers as tobacco for
making cigarettes.
``(15) Smoke constituent.--The term `smoke constituent'
means any chemical or chemical compound in mainstream or
sidestream tobacco smoke that either transfers from any
component of the cigarette to the smoke or that is formed by
the combustion or heating of tobacco, additives, or other
component of the tobacco product.
``(16) Smokeless tobacco.--The term `smokeless tobacco'
means any tobacco product that consists of cut, ground,
powdered, or leaf tobacco and that is intended to be placed
in the oral or nasal cavity.
``(17) State.--The term `State' means any State of the
United States and, for purposes of this chapter, includes the
District of Columbia, the Commonwealth of Puerto Rico, Guam,
the Virgin Islands, American Samoa, Wake Island, Midway
Islands, Kingman Reef, Johnston Atoll, the Northern Mariana
Islands, and any other trust territory or possession of the
United States.

[[Page S2062]]

``(18) Tobacco product manufacturer.--The term `tobacco
product manufacturer' means any person, including any
repacker or relabeler, who--
``(A) manufactures, fabricates, assembles, processes, or
labels a tobacco product; or
``(B) imports a finished cigarette or smokeless tobacco
product for sale or distribution in the United States.
``(19) United states.--The term `United States' means the
50 States of the United States of America and the District of
Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin
Islands, American Samoa, Wake Island, Midway Islands, Kingman
Reef, Johnston Atoll, the Northern Mariana Islands, and any
other trust territory or possession of the United States.

``SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.

``(a) In General.--Tobacco products shall be regulated by
the Secretary under this chapter and shall not be subject to
the provisions of chapter V, unless--
``(1) such products are intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease (within
the meaning of section 201(g)(1)(B) or section 201(h)(2)); or
``(2) a claim is made for such products under section
201(g)(1)(C) or 201(h)(3);
other than modified risk tobacco products approved in
accordance with section 911.
``(b) Applicability.--This chapter shall apply to all
tobacco products subject to the regulations referred to in
section 102 of the Family Smoking Prevention and Tobacco
Control Act, and to any other tobacco products that the
Secretary by regulation deems to be subject to this chapter.
``(c) Scope.--
``(1) In general.--Nothing in this chapter, or any policy
issued or regulation promulgated thereunder, or in sections
101(a), 102, or 103 of title I, title II, or title III of the
Family Smoking Prevention and Tobacco Control Act, shall be
construed to affect, expand, or limit the Secretary's
authority over (including the authority to determine whether
products may be regulated), or the regulation of, products
under this Act that are not tobacco products under chapter V
or any other chapter.
``(2) Limitation of authority.--
``(A) In general.--The provisions of this chapter shall not
apply to tobacco leaf that is not in the possession of a
manufacturer of tobacco products, or to the producers of
tobacco leaf, including tobacco growers, tobacco warehouses,
and tobacco grower cooperatives, nor shall any employee of
the Food and Drug Administration have any authority to enter
onto a farm owned by a producer of tobacco leaf without the
written consent of such producer.
``(B) Exception.--Notwithstanding subparagraph (A), if a
producer of tobacco leaf is also a tobacco product
manufacturer or controlled by a tobacco product manufacturer,
the producer shall be subject to this chapter in the
producer's capacity as a manufacturer.
``(C) Rule of construction.--Nothing in this chapter shall
be construed to grant the Secretary authority to promulgate
regulations on any matter that involves the production of
tobacco leaf or a producer thereof, other than activities by
a manufacturer affecting production.

``SEC. 902. ADULTERATED TOBACCO PRODUCTS.

``A tobacco product shall be deemed to be adulterated if--
``(1) it consists in whole or in part of any filthy,
putrid, or decomposed substance, or is otherwise contaminated
by any added poisonous or added deleterious substance that
may render the product injurious to health;
``(2) it has been prepared, packed, or held under
insanitary conditions whereby it may have been contaminated
with filth, or whereby it may have been rendered injurious to
health;
``(3) its package is composed, in whole or in part, of any
poisonous or deleterious substance which may render the
contents injurious to health;
``(4) it is, or purports to be or is represented as, a
tobacco product which is subject to a tobacco product
standard established under section 907 unless such tobacco
product is in all respects in conformity with such standard;
``(5)(A) it is required by section 910(a) to have premarket
approval and does not have an approved application in effect;
or
``(B) it is in violation of the order approving such an
application;
``(6) the methods used in, or the facilities or controls
used for, its manufacture, packing, or storage are not in
conformity with applicable requirements under section
906(e)(1) or an applicable condition prescribed by an order
under section 906(e)(2); or
``(7) it is in violation of section 911.

``SEC. 903. MISBRANDED TOBACCO PRODUCTS.

``(a) In General.--A tobacco product shall be deemed to be
misbranded--
``(1) if its labeling is false or misleading in any
particular;
``(2) if in package form unless it bears a label
containing--
``(A) the name and place of business of the tobacco product
manufacturer, packer, or distributor;
``(B) an accurate statement of the quantity of the contents
in terms of weight, measure, or numerical count;
``(C) an accurate statement of the percentage of the
tobacco used in the product that is domestically grown
tobacco and the percentage that is foreign grown tobacco; and
``(D) the statement required under section 921(a),

except that under subparagraph (B) reasonable variations
shall be permitted, and exemptions as to small packages shall
be established, by regulations prescribed by the Secretary;
``(3) if any word, statement, or other information required
by or under authority of this chapter to appear on the label
or labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements or
designs in the labeling) and in such terms as to render it
likely to be read and understood by the ordinary individual
under customary conditions of purchase and use;
``(4) if it has an established name, unless its label
bears, to the exclusion of any other nonproprietary name, its
established name prominently printed in type as required by
the Secretary by regulation;
``(5) if the Secretary has issued regulations requiring
that its labeling bear adequate directions for use, or
adequate warnings against use by children, that are necessary
for the protection of users unless its labeling conforms in
all respects to such regulations;
``(6) if it was manufactured, prepared, propagated,
compounded, or processed in any State in an establishment not
duly registered under section 905(b), 905(c), 905(d), or
905(h), if it was not included in a list required by section
905(i), if a notice or other information respecting it was
not provided as required by such section or section 905(j),
or if it does not bear such symbols from the uniform system
for identification of tobacco products prescribed under
section 905(e) as the Secretary by regulation requires;
``(7) if, in the case of any tobacco product distributed or
offered for sale in any State--
``(A) its advertising is false or misleading in any
particular; or
``(B) it is sold or distributed in violation of regulations
prescribed under section 906(d);
``(8) unless, in the case of any tobacco product
distributed or offered for sale in any State, the
manufacturer, packer, or distributor thereof includes in all
advertisements and other descriptive printed matter issued or
caused to be issued by the manufacturer, packer, or
distributor with respect to that tobacco product--
``(A) a true statement of the tobacco product's established
name as described in paragraph (4), printed prominently; and
``(B) a brief statement of--
``(i) the uses of the tobacco product and relevant
warnings, precautions, side effects, and contraindications;
and
``(ii) in the case of specific tobacco products made
subject to a finding by the Secretary after notice and
opportunity for comment that such action is appropriate to
protect the public health, a full description of the
components of such tobacco product or the formula showing
quantitatively each ingredient of such tobacco product to the
extent required in regulations which shall be issued by the
Secretary after an opportunity for a hearing;
``(9) if it is a tobacco product subject to a tobacco
product standard established under section 907, unless it
bears such labeling as may be prescribed in such tobacco
product standard; or
``(10) if there was a failure or refusal--
``(A) to comply with any requirement prescribed under
section 904 or 908; or
``(B) to furnish any material or information required under
section 909.
``(b) Prior Approval of Label Statements.--The Secretary
may, by regulation, require prior approval of statements made
on the label of a tobacco product. No regulation issued under
this subsection may require prior approval by the Secretary
of the content of any advertisement, except for modified risk
tobacco products as provided in section 911. No advertisement
of a tobacco product published after the date of enactment of
the Family Smoking Prevention and Tobacco Control Act shall,
with respect to the language of label statements as
prescribed under section 4 of the Cigarette Labeling and
Advertising Act and section 3 of the Comprehensive Smokeless
Tobacco Health Education Act of 1986 or the regulations
issued under such sections, be subject to the provisions of
sections 12 through 15 of the Federal Trade Commission Act.

``SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE
SECRETARY.

``(a) Requirement.--Not later than 6 months after the date
of enactment of the Family Smoking Prevention and Tobacco
Control Act, each tobacco product manufacturer or importer,
or agents thereof, shall submit to the Secretary the
following information:
``(1) A listing of all ingredients, including tobacco,
substances, compounds, and additives that are, as of such
date, added by the manufacturer to the tobacco, paper,
filter, or other part of each tobacco product by brand and by
quantity in each brand and subbrand.
``(2) A description of the content, delivery, and form of
nicotine in each tobacco product measured in milligrams of
nicotine in accordance with regulations promulgated by the
Secretary in accordance with section 4(a)(5) of the Federal
Cigarette Labeling and Advertising Act.
``(3) A listing of all constituents, including smoke
constituents as applicable, identified by the Secretary as
harmful or potentially harmful to health in each tobacco
product, and as applicable in the smoke of each tobacco
product, by brand and by quantity in each brand and subbrand.
Effective beginning 2 years after the date of enactment of
this chapter, the manufacturer, importer, or

[[Page S2063]]

agent shall comply with regulations promulgated under section
916 in reporting information under this paragraph, where
applicable.
``(4) All documents developed after the date of enactment
of the Family Smoking Prevention and Tobacco Control Act that
relate to health, toxicological, behavioral, or physiologic
effects of current or future tobacco products, their
constituents (including smoke constituents), ingredients,
components, and additives.
``(b) Data Submission.--At the request of the Secretary,
each tobacco product manufacturer or importer of tobacco
products, or agents thereof, shall submit the following:
``(1) Any or all documents (including underlying scientific
information) relating to research activities, and research
findings, conducted, supported, or possessed by the
manufacturer (or agents thereof) on the health,
toxicological, behavioral, or physiologic effects of tobacco
products and their constituents (including smoke
constituents), ingredients, components, and additives.
``(2) Any or all documents (including underlying scientific
information) relating to research activities, and research
findings, conducted, supported, or possessed by the
manufacturer (or agents thereof) that relate to the issue of
whether a reduction in risk to health from tobacco products
can occur upon the employment of technology available or
known to the manufacturer.
``(3) Any or all documents (including underlying scientific
or financial information) relating to marketing research
involving the use of tobacco products or marketing practices
and the effectiveness of such practices used by tobacco
manufacturers and distributors.

An importer of a tobacco product not manufactured in the
United States shall supply the information required of a
tobacco product manufacturer under this subsection.
``(c) Time for Submission.--
``(1) In general.--At least 90 days prior to the delivery
for introduction into interstate commerce of a tobacco
product not on the market on the date of enactment of the
Family Smoking Prevention and Tobacco Control Act, the
manufacturer of such product shall provide the information
required under subsection (a).
``(2) Disclosure of additive.--If at any time a tobacco
product manufacturer adds to its tobacco products a new
tobacco additive or increases the quantity of an existing
tobacco additive, the manufacturer shall, except as provided
in paragraph (3), at least 90 days prior to such action so
advise the Secretary in writing.
``(3) Disclosure of other actions.--If at any time a
tobacco product manufacturer eliminates or decreases an
existing additive, or adds or increases an additive that has
by regulation been designated by the Secretary as an additive
that is not a human or animal carcinogen, or otherwise
harmful to health under intended conditions of use, the
manufacturer shall within 60 days of such action so advise
the Secretary in writing.
``(d) Data List.--
``(1) In general.--Not later than 3 years after the date of
enactment of the Family Smoking Prevention and Tobacco
Control Act, and annually thereafter, the Secretary shall
publish in a format that is understandable and not misleading
to a lay person, and place on public display (in a manner
determined by the Secretary) the list established under
subsection (e).
``(2) Consumer research.--The Secretary shall conduct
periodic consumer research to ensure that the list published
under paragraph (1) is not misleading to lay persons. Not
later than 5 years after the date of enactment of the Family
Smoking Prevention and Tobacco Control Act, the Secretary
shall submit to the appropriate committees of Congress a
report on the results of such research, together with
recommendations on whether such publication should be
continued or modified.
``(e) Data Collection.--Not later than 12 months after the
date of enactment of the Family Smoking Prevention and
Tobacco Control Act, the Secretary shall establish a list of
harmful and potentially harmful constituents, including smoke
constituents, to health in each tobacco product by brand and
by quantity in each brand and subbrand. The Secretary shall
publish a public notice requesting the submission by
interested persons of scientific and other information
concerning the harmful and potentially harmful constituents
in tobacco products and tobacco smoke.

``SEC. 905. ANNUAL REGISTRATION.

``(a) Definitions.--In this section:
``(1) Manufacture, preparation, compounding, or
processing.--The term `manufacture, preparation, compounding,
or processing' shall include repackaging or otherwise
changing the container, wrapper, or labeling of any tobacco
product package in furtherance of the distribution of the
tobacco product from the original place of manufacture to the
person who makes final delivery or sale to the ultimate
consumer or user.
``(2) Name.--The term `name' shall include in the case of a
partnership the name of each partner and, in the case of a
corporation, the name of each corporate officer and director,
and the State of incorporation.
``(b) Registration by Owners and Operators.--On or before
December 31 of each year every person who owns or operates
any establishment in any State engaged in the manufacture,
preparation, compounding, or processing of a tobacco product
or tobacco products shall register with the Secretary the
name, places of business, and all such establishments of that
person.
``(c) Registration of New Owners and Operators.--Every
person upon first engaging in the manufacture, preparation,
compounding, or processing of a tobacco product or tobacco
products in any establishment owned or operated in any State
by that person shall immediately register with the Secretary
that person's name, place of business, and such
establishment.
``(d) Registration of Added Establishments.--Every person
required to register under subsection (b) or (c) shall
immediately register with the Secretary any additional
establishment which that person owns or operates in any State
and in which that person begins the manufacture, preparation,
compounding, or processing of a tobacco product or tobacco
products.
``(e) Uniform Product Identification System.--The Secretary
may by regulation prescribe a uniform system for the
identification of tobacco products and may require that
persons who are required to list such tobacco products under
subsection (i) shall list such tobacco products in accordance
with such system.
``(f) Public Access to Registration Information.--The
Secretary shall make available for inspection, to any person
so requesting, any registration filed under this section.
``(g) Biennial Inspection of Registered Establishments.--
Every establishment in any State registered with the
Secretary under this section shall be subject to inspection
under section 704, and every such establishment engaged in
the manufacture, compounding, or processing of a tobacco
product or tobacco products shall be so inspected by 1 or
more officers or employees duly designated by the Secretary
at least once in the 2-year period beginning with the date of
registration of such establishment under this section and at
least once in every successive 2-year period thereafter.
``(h) Foreign Establishments Shall Register.--Any
establishment within any foreign country engaged in the
manufacture, preparation, compounding, or processing of a
tobacco product or tobacco products, shall register under
this section under regulations promulgated by the Secretary.
Such regulations shall require such establishment to provide
the information required by subsection (i) of this section
and shall include provisions for registration of any such
establishment upon condition that adequate and effective
means are available, by arrangement with the government of
such foreign country or otherwise, to enable the Secretary to
determine from time to time whether tobacco products
manufactured, prepared, compounded, or processed in such
establishment, if imported or offered for import into the
United States, shall be refused admission on any of the
grounds set forth in section 801(a).
``(i) Registration Information.--
``(1) Product list.--Every person who registers with the
Secretary under subsection (b), (c), (d), or (h) shall, at
the time of registration under any such subsection, file with
the Secretary a list of all tobacco products which are being
manufactured, prepared, compounded, or processed by that
person for commercial distribution and which has not been
included in any list of tobacco products filed by that person
with the Secretary under this paragraph or paragraph (2)
before such time of registration. Such list shall be prepared
in such form and manner as the Secretary may prescribe and
shall be accompanied by--
``(A) in the case of a tobacco product contained in the
applicable list with respect to which a tobacco product
standard has been established under section 907 or which is
subject to section 910, a reference to the authority for the
marketing of such tobacco product and a copy of all labeling
for such tobacco product;
``(B) in the case of any other tobacco product contained in
an applicable list, a copy of all consumer information and
other labeling for such tobacco product, a representative
sampling of advertisements for such tobacco product, and,
upon request made by the Secretary for good cause, a copy of
all advertisements for a particular tobacco product; and
``(C) if the registrant filing a list has determined that a
tobacco product contained in such list is not subject to a
tobacco product standard established under section 907, a
brief statement of the basis upon which the registrant made
such determination if the Secretary requests such a statement
with respect to that particular tobacco product.
``(2) Biannual report of any change in product list.--Each
person who registers with the Secretary under this section
shall report to the Secretary once during the month of June
of each year and once during the month of December of each
year the following:
``(A) A list of each tobacco product introduced by the
registrant for commercial distribution which has not been
included in any list previously filed by that person with the
Secretary under this subparagraph or paragraph (1). A list
under this subparagraph shall list a tobacco product by its
established name and shall be accompanied by the other
information required by paragraph (1).
``(B) If since the date the registrant last made a report
under this paragraph that person has discontinued the
manufacture, preparation, compounding, or processing for
commercial distribution of a tobacco product included in a
list filed under subparagraph (A)

[[Page S2064]]

or paragraph (1), notice of such discontinuance, the date of
such discontinuance, and the identity of its established
name.
``(C) If since the date the registrant reported under
subparagraph (B) a notice of discontinuance that person has
resumed the manufacture, preparation, compounding, or
processing for commercial distribution of the tobacco product
with respect to which such notice of discontinuance was
reported, notice of such resumption, the date of such
resumption, the identity of such tobacco product by
established name, and other information required by paragraph
(1), unless the registrant has previously reported such
resumption to the Secretary under this subparagraph.
``(D) Any material change in any information previously
submitted under this paragraph or paragraph (1).
``(j) Report Preceding Introduction of Certain
Substantially-Equivalent Products Into Interstate Commerce.--
``(1) In general.--Each person who is required to register
under this section and who proposes to begin the introduction
or delivery for introduction into interstate commerce for
commercial distribution of a tobacco product intended for
human use that was not commercially marketed (other than for
test marketing) in the United States as of June 1, 2003,
shall, at least 90 days prior to making such introduction or
delivery, report to the Secretary (in such form and manner as
the Secretary shall prescribe)--
``(A) the basis for such person's determination that the
tobacco product is substantially equivalent, within the
meaning of section 910, to a tobacco product commercially
marketed (other than for test marketing) in the United States
as of June 1, 2003, that is in compliance with the
requirements of this Act; and
``(B) action taken by such person to comply with the
requirements under section 907 that are applicable to the
tobacco product.
``(2) Application to certain post june 1, 2003 products.--A
report under this subsection for a tobacco product that was
first introduced or delivered for introduction into
interstate commerce for commercial distribution in the United
States after June 1, 2003, and prior to the date that is 15
months after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act shall be submitted to the
Secretary not later than 15 months after such date of
enactment.
``(3) Exemptions.--
``(A) In general.--The Secretary may by regulation, exempt
from the requirements of this subsection tobacco products
that are modified by adding or deleting a tobacco additive,
or increasing or decreasing the quantity of an existing
tobacco additive, if the Secretary determines that--
``(i) such modification would be a minor modification of a
tobacco product authorized for sale under this Act;
``(ii) a report under this subsection is not necessary to
ensure that permitting the tobacco product to be marketed
would be appropriate for protection of the public health; and
``(iii) an exemption is otherwise appropriate.
``(B) Regulations.--Not later than 9 months after the date
of enactment of the Family Smoking Prevention and Tobacco
Control Act, the Secretary shall issue regulations to
implement this paragraph.

``SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO
PRODUCTS.

``(a) In General.--Any requirement established by or under
section 902, 903, 905, or 909 applicable to a tobacco product
shall apply to such tobacco product until the applicability
of the requirement to the tobacco product has been changed by
action taken under section 907, section 910, section 911, or
subsection (d) of this section, and any requirement
established by or under section 902, 903, 905, or 909 which
is inconsistent with a requirement imposed on such tobacco
product under section 907, section 910, section 911, or
subsection (d) of this section shall not apply to such
tobacco product.
``(b) Information on Public Access and Comment.--Each
notice of proposed rulemaking or other notification under
section 907, 908, 909, 910, or 911 or under this section, any
other notice which is published in the Federal Register with
respect to any other action taken under any such section and
which states the reasons for such action, and each
publication of findings required to be made in connection
with rulemaking under any such section shall set forth--
``(1) the manner in which interested persons may examine
data and other information on which the notice or findings is
based; and
``(2) the period within which interested persons may
present their comments on the notice or findings (including
the need therefore) orally or in writing, which period shall
be at least 60 days but may not exceed 90 days unless the
time is extended by the Secretary by a notice published in
the Federal Register stating good cause therefore.
``(c) Limited Confidentiality of Information.--Any
information reported to or otherwise obtained by the
Secretary or the Secretary's representative under section
903, 904, 907, 908, 909, 910, 911, or 704, or under
subsection (e) or (f) of this section, which is exempt from
disclosure under subsection (a) of section 552 of title 5,
United States Code, by reason of subsection (b)(4) of that
section shall be considered confidential and shall not be
disclosed, except that the information may be disclosed to
other officers or employees concerned with carrying out this
chapter, or when relevant in any proceeding under this
chapter.
``(d) Restrictions.--
``(1) In general.--The Secretary may by regulation require
restrictions on the sale and distribution of a tobacco
product, including restrictions on the access to, and the
advertising and promotion of, the tobacco product, if the
Secretary determines that such regulation would be
appropriate for the protection of the public health. The
Secretary may by regulation impose restrictions on the
advertising and promotion of a tobacco product consistent
with and to full extent permitted by the first amendment to
the Constitution. The finding as to whether such regulation
would be appropriate for the protection of the public health
shall be determined with respect to the risks and benefits to
the population as a whole, including users and non-users of
the tobacco product, and taking into account--
``(A) the increased or decreased likelihood that existing
users of tobacco products will stop using such products; and
``(B) the increased or decreased likelihood that those who
do not use tobacco products will start using such products.

No such regulation may require that the sale or distribution
of a tobacco product be limited to the written or oral
authorization of a practitioner licensed by law to prescribe
medical products.
``(2) Label statements.--The label of a tobacco product
shall bear such appropriate statements of the restrictions
required by a regulation under subsection (a) as the
Secretary may in such regulation prescribe.
``(3) Limitations.--
``(A) In general.--No restrictions under paragraph (1)
may--
``(i) prohibit the sale of any tobacco product in face-to-
face transactions by a specific category of retail outlets;
or
``(ii) establish a minimum age of sale of tobacco products
to any person older than 18 years of age.
``(B) Matchbooks.--For purposes of any regulations issued
by the Secretary, matchbooks of conventional size containing
not more than 20 paper matches, and which are customarily
given away for free with the purchase of tobacco products
shall be considered as adult written publications which shall
be permitted to contain advertising. Notwithstanding the
preceding sentence, if the Secretary finds that such
treatment of matchbooks is not appropriate for the protection
of the public health, the Secretary may determine by
regulation that matchbooks shall not be considered adult
written publications.
``(e) Good Manufacturing Practice Requirements.--
``(1) Methods, facilities, and controls to conform.--
``(A) In general.--The Secretary may, in accordance with
subparagraph (B), prescribe regulations (which may differ
based on the type of tobacco product involved) requiring that
the methods used in, and the facilities and controls used
for, the manufacture, pre-production design validation
(including a process to assess the performance of a tobacco
product), packing and storage of a tobacco product, conform
to current good manufacturing practice, as prescribed in such
regulations, to assure that the public health is protected
and that the tobacco product is in compliance with this
chapter. Good manufacturing practices may include the testing
of raw tobacco for pesticide chemical residues regardless of
whether a tolerance for such chemical residues has been
established.
``(B) Requirements.--The Secretary shall--
``(i) before promulgating any regulation under subparagraph
(A), afford the Tobacco Products Scientific Advisory
Committee an opportunity to submit recommendations with
respect to the regulation proposed to be promulgated;
``(ii) before promulgating any regulation under
subparagraph (A), afford opportunity for an oral hearing;
``(iii) provide the Tobacco Products Scientific Advisory
Committee a reasonable time to make its recommendation with
respect to proposed regulations under subparagraph (A); and
``(iv) in establishing the effective date of a regulation
promulgated under this subsection, take into account the
differences in the manner in which the different types of
tobacco products have historically been produced, the
financial resources of the different tobacco product
manufacturers, and the state of their existing manufacturing
facilities, and shall provide for a reasonable period of time
for such manufacturers to conform to good manufacturing
practices.
``(2) Exemptions; variances.--
``(A) Petition.--Any person subject to any requirement
prescribed under paragraph (1) may petition the Secretary for
a permanent or temporary exemption or variance from such
requirement. Such a petition shall be submitted to the
Secretary in such form and manner as the Secretary shall
prescribe and shall--
``(i) in the case of a petition for an exemption from a
requirement, set forth the basis for the petitioner's
determination that compliance with the requirement is not
required to assure that the tobacco product will be in
compliance with this chapter;
``(ii) in the case of a petition for a variance from a
requirement, set forth the methods proposed to be used in,
and the facilities and

[[Page S2065]]

controls proposed to be used for, the manufacture, packing,
and storage of the tobacco product in lieu of the methods,
facilities, and controls prescribed by the requirement; and
``(iii) contain such other information as the Secretary
shall prescribe.
``(B) Referral to the tobacco products scientific advisory
committee.--The Secretary may refer to the Tobacco Products
Scientific Advisory Committee any petition submitted under
subparagraph (A). The Tobacco Products Scientific Advisory
Committee shall report its recommendations to the Secretary
with respect to a petition referred to it within 60 days
after the date of the petition's referral. Within 60 days
after--
``(i) the date the petition was submitted to the Secretary
under subparagraph (A); or
``(ii) the day after the petition was referred to the
Tobacco Products Scientific Advisory Committee,

whichever occurs later, the Secretary shall by order either
deny the petition or approve it.
``(C) Approval.--The Secretary may approve--
``(i) a petition for an exemption for a tobacco product
from a requirement if the Secretary determines that
compliance with such requirement is not required to assure
that the tobacco product will be in compliance with this
chapter; and
``(ii) a petition for a variance for a tobacco product from
a requirement if the Secretary determines that the methods to
be used in, and the facilities and controls to be used for,
the manufacture, packing, and storage of the tobacco product
in lieu of the methods, controls, and facilities prescribed
by the requirement are sufficient to assure that the tobacco
product will be in compliance with this chapter.
``(D) Conditions.--An order of the Secretary approving a
petition for a variance shall prescribe such conditions
respecting the methods used in, and the facilities and
controls used for, the manufacture, packing, and storage of
the tobacco product to be granted the variance under the
petition as may be necessary to assure that the tobacco
product will be in compliance with this chapter.
``(E) Hearing.--After the issuance of an order under
subparagraph (B) respecting a petition, the petitioner shall
have an opportunity for an informal hearing on such order.
``(3) Compliance.--Compliance with requirements under this
subsection shall not be required before the period ending 3
years after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act.
``(f) Research and Development.--The Secretary may enter
into contracts for research, testing, and demonstrations
respecting tobacco products and may obtain tobacco products
for research, testing, and demonstration purposes without
regard to section 3324(a) and (b) of title 31, United States
Code, and section 5 of title 41, United States Code.

``SEC. 907. TOBACCO PRODUCT STANDARDS.

``(a) In General.--
``(1) Special rule for cigarettes.--A cigarette or any of
its component parts (including the tobacco, filter, or paper)
shall not contain, as a constituent (including a smoke
constituent) or additive, an artificial or natural flavor
(other than tobacco or menthol) or an herb or spice,
including strawberry, grape, orange, clove, cinnamon,
pineapple, vanilla, coconut, licorice, cocoa, chocolate,
cherry, or coffee, that is a characterizing flavor of the
tobacco product or tobacco smoke. Nothing in this
subparagraph shall be construed to limit the Secretary's
authority to take action under this section or other sections
of this Act applicable to menthol or any artificial or
natural flavor, herb, or spice not specified in this
paragraph.
``(2) Revision of tobacco product standards.--The Secretary
may revise the tobacco product standards in paragraph (1) in
accordance with subsection (b).
``(3) Tobacco product standards.--The Secretary may adopt
tobacco product standards in addition to those in paragraph
(1) if the Secretary finds that a tobacco product standard is
appropriate for the protection of the public health. This
finding shall be determined with respect to the risks and
benefits to the population as a whole, including users and
non-users of the tobacco product, and taking into account--
``(A) the increased or decreased likelihood that existing
users of tobacco products will stop using such products; and
``(B) the increased or decreased likelihood that those who
do not use tobacco products will start using such products.
``(4) Content of tobacco product standards.--A tobacco
product standard established under this section for a tobacco
product--
``(A) shall include provisions that are appropriate for the
protection of the public health, including provisions, where
appropriate--
``(i) for the reduction of nicotine yields of the product;
``(ii) for the reduction or elimination of other
constituents, including smoke constituents, or harmful
components of the product; or
``(iii) relating to any other requirement under
subparagraph (B);
``(B) shall, where appropriate for the protection of the
public health, include--
``(i) provisions respecting the construction, components,
ingredients, additives, constituents, including smoke
constituents, and properties of the tobacco product;
``(ii) provisions for the testing (on a sample basis or, if
necessary, on an individual basis) of the tobacco product;
``(iii) provisions for the measurement of the tobacco
product characteristics of the tobacco product;
``(iv) provisions requiring that the results of each or of
certain of the tests of the tobacco product required to be
made under clause (ii) show that the tobacco product is in
conformity with the portions of the standard for which the
test or tests were required; and
``(v) a provision requiring that the sale and distribution
of the tobacco product be restricted but only to the extent
that the sale and distribution of a tobacco product may be
restricted under a regulation under section 906(d); and
``(C) shall, where appropriate, require the use and
prescribe the form and content of labeling for the proper use
of the tobacco product.
``(5) Periodic re-evaluation of tobacco product
standards.--The Secretary shall provide for periodic
evaluation of tobacco product standards established under
this section to determine whether such standards should be
changed to reflect new medical, scientific, or other
technological data. The Secretary may provide for testing
under paragraph (4)(B) by any person.
``(6) Involvement of other agencies; informed persons.--In
carrying out duties under this section, the Secretary shall
endeavor to--
``(A) use personnel, facilities, and other technical
support available in other Federal agencies;
``(B) consult with other Federal agencies concerned with
standard-setting and other nationally or internationally
recognized standard-setting entities; and
``(C) invite appropriate participation, through joint or
other conferences, workshops, or other means, by informed
persons representative of scientific, professional, industry,
agricultural, or consumer organizations who in the
Secretary's judgment can make a significant contribution.
``(b) Establishment of Standards.--
``(1) Notice.--
``(A) In general.--The Secretary shall publish in the
Federal Register a notice of proposed rulemaking for the
establishment, amendment, or revocation of any tobacco
product standard.
``(B) Requirements of notice.--A notice of proposed
rulemaking for the establishment or amendment of a tobacco
product standard for a tobacco product shall--
``(i) set forth a finding with supporting justification
that the tobacco product standard is appropriate for the
protection of the public health;
``(ii) set forth proposed findings with respect to the risk
of illness or injury that the tobacco product standard is
intended to reduce or eliminate; and
``(iii) invite interested persons to submit an existing
tobacco product standard for the tobacco product, including a
draft or proposed tobacco product standard, for consideration
by the Secretary.
``(C) Standard.--Upon a determination by the Secretary that
an additive, constituent (including smoke constituent), or
other component of the product that is the subject of the
proposed tobacco product standard is harmful, it shall be the
burden of any party challenging the proposed standard to
prove that the proposed standard will not reduce or eliminate
the risk of illness or injury.
``(D) Finding.--A notice of proposed rulemaking for the
revocation of a tobacco product standard shall set forth a
finding with supporting justification that the tobacco
product standard is no longer appropriate for the protection
of the public health.
``(E) Consideration by secretary.--The Secretary shall
consider all information submitted in connection with a
proposed standard, including information concerning the
countervailing effects of the tobacco product standard on the
health of adolescent tobacco users, adult tobacco users, or
non-tobacco users, such as the creation of a significant
demand for contraband or other tobacco products that do not
meet the requirements of this chapter and the significance of
such demand, and shall issue the standard if the Secretary
determines that the standard would be appropriate for the
protection of the public health.
``(F) Comment.--The Secretary shall provide for a comment
period of not less than 60 days.
``(2) Promulgation.--
``(A) In general.--After the expiration of the period for
comment on a notice of proposed rulemaking published under
paragraph (1) respecting a tobacco product standard and after
consideration of such comments and any report from the
Tobacco Products Scientific Advisory Committee, the Secretary
shall--
``(i) promulgate a regulation establishing a tobacco
product standard and publish in the Federal Register findings
on the matters referred to in paragraph (1); or
``(ii) publish a notice terminating the proceeding for the
development of the standard together with the reasons for
such termination.
``(B) Effective date.--A regulation establishing a tobacco
product standard shall set forth the date or dates upon which
the standard shall take effect, but no such regulation may
take effect before 1 year after the date

[[Page S2066]]

of its publication unless the Secretary determines that an
earlier effective date is necessary for the protection of the
public health. Such date or dates shall be established so as
to minimize, consistent with the public health, economic loss
to, and disruption or dislocation of, domestic and
international trade.
``(3) Power reserved to congress.--Because of the
importance of a decision of the Secretary to issue a
regulation establishing a tobacco product standard--
``(A) banning all cigarettes, all smokeless tobacco
products, all little cigars, all cigars other than little
cigars, all pipe tobacco, or all roll your own tobacco
products; or
``(B) requiring the reduction of nicotine yields of a
tobacco product to zero,

Congress expressly reserves to itself such power.
``(4) Amendment; revocation.--
``(A) Authority.--The Secretary, upon the Secretary's own
initiative or upon petition of an interested person may by a
regulation, promulgated in accordance with the requirements
of paragraphs (1) and (2)(B), amend or revoke a tobacco
product standard.
``(B) Effective date.--The Secretary may declare a proposed
amendment of a tobacco product standard to be effective on
and after its publication in the Federal Register and until
the effective date of any final action taken on such
amendment if the Secretary determines that making it so
effective is in the public interest.
``(5) Reference to advisory committee.--
``(A) In general.--The Secretary may refer a proposed
regulation for the establishment, amendment, or revocation of
a tobacco product standard to the Tobacco Products Scientific
Advisory Committee for a report and recommendation with
respect to any matter involved in the proposed regulation
which requires the exercise of scientific judgment.
``(B) Initiation of referral.--The Secretary may make a
referral under this paragraph--
``(i) on the Secretary's own initiative; or
``(ii) upon the request of an interested person that--

``(I) demonstrates good cause for the referral; and
``(II) is made before the expiration of the period for
submission of comments on the proposed regulation.

``(C) Provision of data.--If a proposed regulation is
referred under this paragraph to the Tobacco Products
Scientific Advisory Committee, the Secretary shall provide
the Advisory Committee with the data and information on which
such proposed regulation is based.
``(D) Report and recommendation.--The Tobacco Products
Scientific Advisory Committee shall, within 60 days after the
referral of a proposed regulation under this paragraph and
after independent study of the data and information furnished
to it by the Secretary and other data and information before
it, submit to the Secretary a report and recommendation
respecting such regulation, together with all underlying data
and information and a statement of the reason or basis for
the recommendation.
``(E) Public availability.--The Secretary shall make a copy
of each report and recommendation under subparagraph (D)
publicly available.

``SEC. 908. NOTIFICATION AND OTHER REMEDIES.

``(a) Notification.--If the Secretary determines that--
``(1) a tobacco product which is introduced or delivered
for introduction into interstate commerce for commercial
distribution presents an unreasonable risk of substantial
harm to the public health; and
``(2) notification under this subsection is necessary to
eliminate the unreasonable risk of such harm and no more
practicable means is available under the provisions of this
chapter (other than this section) to eliminate such risk,

the Secretary may issue such order as may be necessary to
assure that adequate notification is provided in an
appropriate form, by the persons and means best suited under
the circumstances involved, to all persons who should
properly receive such notification in order to eliminate such
risk. The Secretary may order notification by any appropriate
means, including public service announcements. Before issuing
an order under this subsection, the Secretary shall consult
with the persons who are to give notice under the order.
``(b) No Exemption From Other Liability.--Compliance with
an order issued under this section shall not relieve any
person from liability under Federal or State law. In awarding
damages for economic loss in an action brought for the
enforcement of any such liability, the value to the plaintiff
in such action of any remedy provided under such order shall
be taken into account.
``(c) Recall Authority.--
``(1) In general.--If the Secretary finds that there is a
reasonable probability that a tobacco product contains a
manufacturing or other defect not ordinarily contained in
tobacco products on the market that would cause serious,
adverse health consequences or death, the Secretary shall
issue an order requiring the appropriate person (including
the manufacturers, importers, distributors, or retailers of
the tobacco product) to immediately cease distribution of
such tobacco product. The order shall provide the person
subject to the order with an opportunity for an informal
hearing, to be held not later than 10 days after the date of
the issuance of the order, on the actions required by the
order and on whether the order should be amended to require a
recall of such tobacco product. If, after providing an
opportunity for such a hearing, the Secretary determines that
inadequate grounds exist to support the actions required by
the order, the Secretary shall vacate the order.
``(2) Amendment of order to require recall.--
``(A) In general.--If, after providing an opportunity for
an informal hearing under paragraph (1), the Secretary
determines that the order should be amended to include a
recall of the tobacco product with respect to which the order
was issued, the Secretary shall, except as provided in
subparagraph (B), amend the order to require a recall. The
Secretary shall specify a timetable in which the tobacco
product recall will occur and shall require periodic reports
to the Secretary describing the progress of the recall.
``(B) Notice.--An amended order under subparagraph (A)--
``(i) shall not include recall of a tobacco product from
individuals; and
``(ii) shall provide for notice to persons subject to the
risks associated with the use of such tobacco product.

In providing the notice required by clause (ii), the
Secretary may use the assistance of retailers and other
persons who distributed such tobacco product. If a
significant number of such persons cannot be identified, the
Secretary shall notify such persons under section 705(b).
``(3) Remedy not exclusive.--The remedy provided by this
subsection shall be in addition to remedies provided by
subsection (a) of this section.

``SEC. 909. RECORDS AND REPORTS ON TOBACCO PRODUCTS.

``(a) In General.--Every person who is a tobacco product
manufacturer or importer of a tobacco product shall establish
and maintain such records, make such reports, and provide
such information, as the Secretary may by regulation
reasonably require to assure that such tobacco product is not
adulterated or misbranded and to otherwise protect public
health. Regulations prescribed under the preceding sentence--
``(1) may require a tobacco product manufacturer or
importer to report to the Secretary whenever the manufacturer
or importer receives or otherwise becomes aware of
information that reasonably suggests that one of its marketed
tobacco products may have caused or contributed to a serious
unexpected adverse experience associated with the use of the
product or any significant increase in the frequency of a
serious, expected adverse product experience;
``(2) shall require reporting of other significant adverse
tobacco product experiences as determined by the Secretary to
be necessary to be reported;
``(3) shall not impose requirements unduly burdensome to a
tobacco product manufacturer or importer, taking into account
the cost of complying with such requirements and the need for
the protection of the public health and the implementation of
this chapter;
``(4) when prescribing the procedure for making requests
for reports or information, shall require that each request
made under such regulations for submission of a report or
information to the Secretary state the reason or purpose for
such request and identify to the fullest extent practicable
such report or information;
``(5) when requiring submission of a report or information
to the Secretary, shall state the reason or purpose for the
submission of such report or information and identify to the
fullest extent practicable such report or information; and
``(6) may not require that the identity of any patient or
user be disclosed in records, reports, or information
required under this subsection unless required for the
medical welfare of an individual, to determine risks to
public health of a tobacco product, or to verify a record,
report, or information submitted under this chapter.

In prescribing regulations under this subsection, the
Secretary shall have due regard for the professional ethics
of the medical profession and the interests of patients. The
prohibitions of paragraph (6) continue to apply to records,
reports, and information concerning any individual who has
been a patient, irrespective of whether or when he ceases to
be a patient.
``(b) Reports of Removals and Corrections.--
``(1) In general.--Except as provided in paragraph (2), the
Secretary shall by regulation require a tobacco product
manufacturer or importer of a tobacco product to report
promptly to the Secretary any corrective action taken or
removal from the market of a tobacco product undertaken by
such manufacturer or importer if the removal or correction
was undertaken--
``(A) to reduce a risk to health posed by the tobacco
product; or
``(B) to remedy a violation of this chapter caused by the
tobacco product which may present a risk to health.

A tobacco product manufacturer or importer of a tobacco
product who undertakes a corrective action or removal from
the market of a tobacco product which is not required to be
reported under this subsection shall keep a record of such
correction or removal.
``(2) Exception.--No report of the corrective action or
removal of a tobacco product may be required under paragraph
(1) if a report of the corrective action or removal is
required and has been submitted under subsection (a).

[[Page S2067]]

``SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TOBACCO
PRODUCTS.

``(a) In General.--
``(1) New tobacco product defined.--For purposes of this
section the term `new tobacco product' means--
``(A) any tobacco product (including those products in test
markets) that was not commercially marketed in the United
States as of June 1, 2003; or
``(B) any modification (including a change in design, any
component, any part, or any constituent, including a smoke
constituent, or in the content, delivery or form of nicotine,
or any other additive or ingredient) of a tobacco product
where the modified product was commercially marketed in the
United States after June 1, 2003.
``(2) Premarket approval required.--
``(A) New products.--Approval under this section of an
application for premarket approval for any new tobacco
product is required unless--
``(i) the manufacturer has submitted a report under section
905(j); and
``(ii) the Secretary has issued an order that the tobacco
product--

``(I) is substantially equivalent to a tobacco product
commercially marketed (other than for test marketing) in the
United States as of June 1, 2003; and
``(II)(aa) is in compliance with the requirements of this
Act; or
``(bb) is exempt from the requirements of section 905(j)
pursuant to a regulation issued under section 905(j)(3).

``(B) Application to certain post june 1, 2003 products.--
Subparagraph (A) shall not apply to a tobacco product--
``(i) that was first introduced or delivered for
introduction into interstate commerce for commercial
distribution in the United States after June 1, 2003, and
prior to the date that is 15 months after the date of
enactment of the Family Smoking Prevention and Tobacco
Control Act; and
``(ii) for which a report was submitted under section
905(j) within such 15-month period,

except that subparagraph (A) shall apply to the tobacco
product if the Secretary issues an order that the tobacco
product is not substantially equivalent.
``(3) Substantially equivalent defined.--
``(A) In general.--In this section and section 905(j), the
terms `substantially equivalent' or `substantial equivalence'
mean, with respect to the tobacco product being compared to
the predicate tobacco product, that the Secretary by order
has found that the tobacco product--
``(i) has the same characteristics as the predicate tobacco
product; or
``(ii) has different characteristics and the information
submitted contains information, including clinical data if
deemed necessary by the Secretary, that demonstrates that it
is not appropriate to regulate the product under this section
because the product does not raise different questions of
public health.
``(B) Characteristics.--In subparagraph (A), the term
`characteristics' means the materials, ingredients, design,
composition, heating source, or other features of a tobacco
product.
``(C) Limitation.--A tobacco product may not be found to be
substantially equivalent to a predicate tobacco product that
has been removed from the market at the initiative of the
Secretary or that has been determined by a judicial order to
be misbranded or adulterated.
``(4) Health information.--
``(A) Summary.--As part of a submission under section
905(j) respecting a tobacco product, the person required to
file a premarket notification under such section shall
provide an adequate summary of any health information related
to the tobacco product or state that such information will be
made available upon request by any person.
``(B) Required information.--Any summary under subparagraph
(A) respecting a tobacco product shall contain detailed
information regarding data concerning adverse health effects
and shall be made available to the public by the Secretary
within 30 days of the issuance of a determination that such
tobacco product is substantially equivalent to another
tobacco product.
``(b) Application.--
``(1) Contents.--An application for premarket approval
shall contain--
``(A) full reports of all information, published or known
to, or which should reasonably be known to, the applicant,
concerning investigations which have been made to show the
health risks of such tobacco product and whether such tobacco
product presents less risk than other tobacco products;
``(B) a full statement of the components, ingredients,
additives, and properties, and of the principle or principles
of operation, of such tobacco product;
``(C) a full description of the methods used in, and the
facilities and controls used for, the manufacture,
processing, and, when relevant, packing and installation of,
such tobacco product;
``(D) an identifying reference to any tobacco product
standard under section 907 which would be applicable to any
aspect of such tobacco product, and either adequate
information to show that such aspect of such tobacco product
fully meets such tobacco product standard or adequate
information to justify any deviation from such standard;
``(E) such samples of such tobacco product and of
components thereof as the Secretary may reasonably require;
``(F) specimens of the labeling proposed to be used for
such tobacco product; and
``(G) such other information relevant to the subject matter
of the application as the Secretary may require.
``(2) Reference to tobacco products scientific advisory
committee.--Upon receipt of an application meeting the
requirements set forth in paragraph (1), the Secretary--
``(A) may, on the Secretary's own initiative; or
``(B) may, upon the request of an applicant,

refer such application to the Tobacco Products Scientific
Advisory Committee for reference and for submission (within
such period as the Secretary may establish) of a report and
recommendation respecting approval of the application,
together with all underlying data and the reasons or basis
for the recommendation.
``(c) Action on Application.--
``(1) Deadline.--
``(A) In general.--As promptly as possible, but in no event
later than 180 days after the receipt of an application under
subsection (b), the Secretary, after considering the report
and recommendation submitted under paragraph (2) of such
subsection, shall--
``(i) issue an order approving the application if the
Secretary finds that none of the grounds for denying approval
specified in paragraph (2) of this subsection applies; or
``(ii) deny approval of the application if the Secretary
finds (and sets forth the basis for such finding as part of
or accompanying such denial) that 1 or more grounds for
denial specified in paragraph (2) of this subsection apply.
``(B) Restrictions on sale and distribution.--An order
approving an application for a tobacco product may require as
a condition to such approval that the sale and distribution
of the tobacco product be restricted but only to the extent
that the sale and distribution of a tobacco product may be
restricted under a regulation under section 906(d).
``(2) Denial of approval.--The Secretary shall deny
approval of an application for a tobacco product if, upon the
basis of the information submitted to the Secretary as part
of the application and any other information before the
Secretary with respect to such tobacco product, the Secretary
finds that--
``(A) there is a lack of a showing that permitting such
tobacco product to be marketed would be appropriate for the
protection of the public health;
``(B) the methods used in, or the facilities or controls
used for, the manufacture, processing, or packing of such
tobacco product do not conform to the requirements of section
906(e);
``(C) based on a fair evaluation of all material facts, the
proposed labeling is false or misleading in any particular;
or
``(D) such tobacco product is not shown to conform in all
respects to a tobacco product standard in effect under
section 907, compliance with which is a condition to approval
of the application, and there is a lack of adequate
information to justify the deviation from such standard.
``(3) Denial information.--Any denial of an application
shall, insofar as the Secretary determines to be practicable,
be accompanied by a statement informing the applicant of the
measures required to place such application in approvable
form (which measures may include further research by the
applicant in accordance with 1 or more protocols prescribed
by the Secretary).
``(4) Basis for finding.--For purposes of this section, the
finding as to whether approval of a tobacco product is
appropriate for the protection of the public health shall be
determined with respect to the risks and benefits to the
population as a whole, including users and nonusers of the
tobacco product, and taking into account--
``(A) the increased or decreased likelihood that existing
users of tobacco products will stop using such products; and
``(B) the increased or decreased likelihood that those who
do not use tobacco products will start using such products.
``(5) Basis for action.--
``(A) Investigations.--For purposes of paragraph (2)(A),
whether permitting a tobacco product to be marketed would be
appropriate for the protection of the public health shall,
when appropriate, be determined on the basis of well-
controlled investigations, which may include 1 or more
clinical investigations by experts qualified by training and
experience to evaluate the tobacco product.
``(B) Other evidence.--If the Secretary determines that
there exists valid scientific evidence (other than evidence
derived from investigations described in subparagraph (A))
which is sufficient to evaluate the tobacco product the
Secretary may authorize that the determination for purposes
of paragraph (2)(A) be made on the basis of such evidence.
``(d) Withdrawal and Temporary Suspension.--
``(1) In general.--The Secretary shall, upon obtaining,
where appropriate, advice on scientific matters from the
Tobacco Products Scientific Advisory Committee, and after due
notice and opportunity for informal hearing to the holder of
an approved application for a tobacco product, issue an order
withdrawing approval of the application if the Secretary
finds--
``(A) that the continued marketing of such tobacco product
no longer is appropriate for the protection of the public
health;
``(B) that the application contained or was accompanied by
an untrue statement of a material fact;
``(C) that the applicant--

[[Page S2068]]

``(i) has failed to establish a system for maintaining
records, or has repeatedly or deliberately failed to maintain
records or to make reports, required by an applicable
regulation under section 909;
``(ii) has refused to permit access to, or copying or
verification of, such records as required by section 704; or
``(iii) has not complied with the requirements of section
905;
``(D) on the basis of new information before the Secretary
with respect to such tobacco product, evaluated together with
the evidence before the Secretary when the application was
approved, that the methods used in, or the facilities and
controls used for, the manufacture, processing, packing, or
installation of such tobacco product do not conform with the
requirements of section 906(e) and were not brought into
conformity with such requirements within a reasonable time
after receipt of written notice from the Secretary of
nonconformity;
``(E) on the basis of new information before the Secretary,
evaluated together with the evidence before the Secretary
when the application was approved, that the labeling of such
tobacco product, based on a fair evaluation of all material
facts, is false or misleading in any particular and was not
corrected within a reasonable time after receipt of written
notice from the Secretary of such fact; or
``(F) on the basis of new information before the Secretary,
evaluated together with the evidence before the Secretary
when the application was approved, that such tobacco product
is not shown to conform in all respects to a tobacco product
standard which is in effect under section 907, compliance
with which was a condition to approval of the application,
and that there is a lack of adequate information to justify
the deviation from such standard.
``(2) Appeal.--The holder of an application subject to an
order issued under paragraph (1) withdrawing approval of the
application may, by petition filed on or before the 30th day
after the date upon which such holder receives notice of such
withdrawal, obtain review thereof in accordance with section
912.
``(3) Temporary suspension.--If, after providing an
opportunity for an informal hearing, the Secretary determines
there is reasonable probability that the continuation of
distribution of a tobacco product under an approved
application would cause serious, adverse health consequences
or death, that is greater than ordinarily caused by tobacco
products on the market, the Secretary shall by order
temporarily suspend the approval of the application approved
under this section. If the Secretary issues such an order,
the Secretary shall proceed expeditiously under paragraph (1)
to withdraw such application.
``(e) Service of Order.--An order issued by the Secretary
under this section shall be served--
``(1) in person by any officer or employee of the
department designated by the Secretary; or
``(2) by mailing the order by registered mail or certified
mail addressed to the applicant at the applicant's last known
address in the records of the Secretary.
``(f) Records.--
``(1) Additional information.--In the case of any tobacco
product for which an approval of an application filed under
subsection (b) is in effect, the applicant shall establish
and maintain such records, and make such reports to the
Secretary, as the Secretary may by regulation, or by order
with respect to such application, prescribe on the basis of a
finding that such records and reports are necessary in order
to enable the Secretary to determine, or facilitate a
determination of, whether there is or may be grounds for
withdrawing or temporarily suspending such approval.
``(2) Access to records.--Each person required under this
section to maintain records, and each person in charge or
custody thereof, shall, upon request of an officer or
employee designated by the Secretary, permit such officer or
employee at all reasonable times to have access to and copy
and verify such records.
``(g) Investigational Tobacco Product Exemption for
Investigational Use.--The Secretary may exempt tobacco
products intended for investigational use from the provisions
of this chapter under such conditions as the Secretary may by
regulation prescribe.

``SEC. 911. MODIFIED RISK TOBACCO PRODUCTS.

``(a) In General.--No person may introduce or deliver for
introduction into interstate commerce any modified risk
tobacco product unless approval of an application filed
pursuant to subsection (d) is effective with respect to such
product.
``(b) Definitions.--In this section:
``(1) Modified risk tobacco product.--The term `modified
risk tobacco product' means any tobacco product that is sold
or distributed for use to reduce harm or the risk of tobacco-
related disease associated with commercially marketed tobacco
products.
``(2) Sold or distributed.--
``(A) In general.--With respect to a tobacco product, the
term `sold or distributed for use to reduce harm or the risk
of tobacco-related disease associated with commercially
marketed tobacco products' means a tobacco product--
``(i) the label, labeling, or advertising of which
represents explicitly or implicitly that--

``(I) the tobacco product presents a lower risk of tobacco-
related disease or is less harmful than one or more other
commercially marketed tobacco products;
``(II) the tobacco product or its smoke contains a reduced
level of a substance or presents a reduced exposure to a
substance; or
``(III) the tobacco product or its smoke does not contain
or is free of a substance;

``(ii) the label, labeling, or advertising of which uses
the descriptors `light', `mild', or `low' or similar
descriptors; or
``(iii) the tobacco product manufacturer of which has taken
any action directed to consumers through the media or
otherwise, other than by means of the tobacco product's
label, labeling, or advertising, after the date of enactment
of the Family Smoking Prevention and Tobacco Control Act,
respecting the product that would be reasonably expected to
result in consumers believing that the tobacco product or its
smoke may present a lower risk of disease or is less harmful
than one or more commercially marketed tobacco products, or
presents a reduced exposure to, or does not contain or is
free of, a substance or substances.
``(B) Limitation.--No tobacco product shall be considered
to be `sold or distributed for use to reduce harm or the risk
of tobacco-related disease associated with commercially
marketed tobacco products', except as described in
subparagraph (A).
``(c) Tobacco Dependence Products.--A product that is
intended to be used for the treatment of tobacco dependence,
including smoking cessation, is not a modified risk tobacco
product under this section and is subject to the requirements
of chapter V.
``(d) Filing.--Any person may file with the Secretary an
application for a modified risk tobacco product. Such
application shall include--
``(1) a description of the proposed product and any
proposed advertising and labeling;
``(2) the conditions for using the product;
``(3) the formulation of the product;
``(4) sample product labels and labeling;
``(5) all documents (including underlying scientific
information) relating to research findings conducted,
supported, or possessed by the tobacco product manufacturer
relating to the effect of the product on tobacco-related
diseases and health-related conditions, including information
both favorable and unfavorable to the ability of the product
to reduce risk or exposure and relating to human health;
``(6) data and information on how consumers actually use
the tobacco product; and
``(7) such other information as the Secretary may require.
``(e) Public Availability.--The Secretary shall make the
application described in subsection (d) publicly available
(except matters in the application which are trade secrets or
otherwise confidential, commercial information) and shall
request comments by interested persons on the information
contained in the application and on the label, labeling, and
advertising accompanying such application.
``(f) Advisory Committee.--
``(1) In general.--The Secretary shall refer to the Tobacco
Products Scientific Advisory Committee any application
submitted under this subsection.
``(2) Recommendations.--Not later than 60 days after the
date an application is referred to the Tobacco Products
Scientific Advisory Committee under paragraph (1), the
Advisory Committee shall report its recommendations on the
application to the Secretary.
``(g) Approval.--
``(1) Modified risk products.--Except as provided in
paragraph (2), the Secretary shall approve an application for
a modified risk tobacco product filed under this section only
if the Secretary determines that the applicant has
demonstrated that such product, as it is actually used by
consumers, will--
``(A) significantly reduce harm and the risk of tobacco-
related disease to individual tobacco users; and
``(B) benefit the health of the population as a whole
taking into account both users of tobacco products and
persons who do not currently use tobacco products.
``(2) Special rule for certain products.--
``(A) In general.--The Secretary may approve an application
for a tobacco product that has not been approved as a
modified risk tobacco product pursuant to paragraph (1) if
the Secretary makes the findings required under this
paragraph and determines that the applicant has demonstrated
that--
``(i) the approval of the application would be appropriate
to promote the public health;
``(ii) any aspect of the label, labeling, and advertising
for such product that would cause the tobacco product to be a
modified risk tobacco product under subsection (b)(2) is
limited to an explicit or implicit representation that such
tobacco product or its smoke contains or is free of a
substance or contains a reduced level of a substance, or
presents a reduced exposure to a substance in tobacco smoke;
``(iii) scientific evidence is not available and, using the
best available scientific methods, cannot be made available
without conducting long-term epidemiological studies for an
application to meet the standards set forth in paragraph (1);
and
``(iv) the scientific evidence that is available without
conducting long-term epidemiological studies demonstrates
that a measurable and substantial reduction in morbidity or
mortality among individual tobacco users is anticipated in
subsequent studies.

[[Page S2069]]

``(B) Additional findings required.--In order to approve an
application under subparagraph (A) the Secretary must also
find that the applicant has demonstrated that--
``(i) the magnitude of the overall reductions in exposure
to the substance or substances which are the subject of the
application is substantial, such substance or substances are
harmful, and the product as actually used exposes consumers
to the specified reduced level of the substance or
substances;
``(ii) the product as actually used by consumers will not
expose them to higher levels of other harmful substances
compared to the similar types of tobacco products then on the
market unless such increases are minimal and the anticipated
overall impact of use of the product remains a substantial
and measurable reduction in overall morbidity and mortality
among individual tobacco users;
``(iii) testing of actual consumer perception shows that,
as the applicant proposes to label and market the product,
consumers will not be misled into believing that the
product--

``(I) is or has been demonstrated to be less harmful; or
``(II) presents or has been demonstrated to present less of
a risk of disease than 1 or more other commercially marketed
tobacco products; and

``(iv) approval of the application is expected to benefit
the health of the population as a whole taking into account
both users of tobacco products and persons who do not
currently use tobacco products.
``(C) Conditions of approval.--
``(i) In general.--Applications approved under this
paragraph shall be limited to a term of not more than 5
years, but may be renewed upon a finding by the Secretary
that the requirements of this paragraph continue to be
satisfied based on the filing of a new application.
``(ii) Agreements by applicant.--Applications approved
under this paragraph shall be conditioned on the applicant's
agreement to conduct post-market surveillance and studies and
to submit to the Secretary the results of such surveillance
and studies to determine the impact of the application
approval on consumer perception, behavior, and health and to
enable the Secretary to review the accuracy of the
determinations upon which the approval was based in
accordance with a protocol approved by the Secretary.
``(iii) Annual submission.--The results of such post-market
surveillance and studies described in clause (ii) shall be
submitted annually.
``(3) Basis.--The determinations under paragraphs (1) and
(2) shall be based on--
``(A) the scientific evidence submitted by the applicant;
and
``(B) scientific evidence and other information that is
available to the Secretary.
``(4) Benefit to health of individuals and of population as
a whole.--In making the determinations under paragraphs (1)
and (2), the Secretary shall take into account--
``(A) the relative health risks to individuals of the
tobacco product that is the subject of the application;
``(B) the increased or decreased likelihood that existing
users of tobacco products who would otherwise stop using such
products will switch to the tobacco product that is the
subject of the application;
``(C) the increased or decreased likelihood that persons
who do not use tobacco products will start using the tobacco
product that is the subject of the application;
``(D) the risks and benefits to persons from the use of the
tobacco product that is the subject of the application as
compared to the use of products for smoking cessation
approved under chapter V to treat nicotine dependence; and
``(E) comments, data, and information submitted by
interested persons.
``(h) Additional Conditions for Approval.--
``(1) Modified risk products.--The Secretary shall require
for the approval of an application under this section that
any advertising or labeling concerning modified risk products
enable the public to comprehend the information concerning
modified risk and to understand the relative significance of
such information in the context of total health and in
relation to all of the diseases and health-related conditions
associated with the use of tobacco products.
``(2) Comparative claims.--
``(A) In general.--The Secretary may require for the
approval of an application under this subsection that a claim
comparing a tobacco product to 1 or more other commercially
marketed tobacco products shall compare the tobacco product
to a commercially marketed tobacco product that is
representative of that type of tobacco product on the market
(for example the average value of the top 3 brands of an
established regular tobacco product).
``(B) Quantitative comparisons.--The Secretary may also
require, for purposes of subparagraph (A), that the percent
(or fraction) of change and identity of the reference tobacco
product and a quantitative comparison of the amount of the
substance claimed to be reduced shall be stated in immediate
proximity to the most prominent claim.
``(3) Label disclosure.--
``(A) In general.--The Secretary may require the disclosure
on the label of other substances in the tobacco product, or
substances that may be produced by the consumption of that
tobacco product, that may affect a disease or health-related
condition or may increase the risk of other diseases or
health-related conditions associated with the use of tobacco
products.
``(B) Conditions of use.--If the conditions of use of the
tobacco product may affect the risk of the product to human
health, the Secretary may require the labeling of conditions
of use.
``(4) Time.--The Secretary shall limit an approval under
subsection (g)(1) for a specified period of time.
``(5) Advertising.--The Secretary may require that an
applicant, whose application has been approved under this
subsection, comply with requirements relating to advertising
and promotion of the tobacco product.
``(i) Postmarket Surveillance and Studies.--
``(1) In general.--The Secretary shall require that an
applicant under subsection (g)(1) conduct post market
surveillance and studies for a tobacco product for which an
application has been approved to determine the impact of the
application approval on consumer perception, behavior, and
health, to enable the Secretary to review the accuracy of the
determinations upon which the approval was based, and to
provide information that the Secretary determines is
otherwise necessary regarding the use or health risks
involving the tobacco product. The results of post-market
surveillance and studies shall be submitted to the Secretary
on an annual basis.
``(2) Surveillance protocol.--Each applicant required to
conduct a surveillance of a tobacco product under paragraph
(1) shall, within 30 days after receiving notice that the
applicant is required to conduct such surveillance, submit,
for the approval of the Secretary, a protocol for the
required surveillance. The Secretary, within 60 days of the
receipt of such protocol, shall determine if the principal
investigator proposed to be used in the surveillance has
sufficient qualifications and experience to conduct such
surveillance and if such protocol will result in collection
of the data or other information designated by the Secretary
as necessary to protect the public health.
``(j) Withdrawal of Approval.--The Secretary, after an
opportunity for an informal hearing, shall withdraw the
approval of an application under this section if the
Secretary determines that--
``(1) the applicant, based on new information, can no
longer make the demonstrations required under subsection (g),
or the Secretary can no longer make the determinations
required under subsection (g);
``(2) the application failed to include material
information or included any untrue statement of material
fact;
``(3) any explicit or implicit representation that the
product reduces risk or exposure is no longer valid,
including if--
``(A) a tobacco product standard is established pursuant to
section 907;
``(B) an action is taken that affects the risks presented
by other commercially marketed tobacco products that were
compared to the product that is the subject of the
application; or
``(C) any postmarket surveillance or studies reveal that
the approval of the application is no longer consistent with
the protection of the public health;
``(4) the applicant failed to conduct or submit the
postmarket surveillance and studies required under subsection
(g)(2)(C)(ii) or (i); or
``(5) the applicant failed to meet a condition imposed
under subsection (h).
``(k) Chapter IV or V.--A product approved in accordance
with this section shall not be subject to chapter IV or V.
``(l) Implementing Regulations or Guidance.--
``(1) Scientific evidence.--Not later than 2 years after
the date of enactment of the Family Smoking Prevention and
Tobacco Control Act, the Secretary shall issue regulations or
guidance (or any combination thereof) on the scientific
evidence required for assessment and ongoing review of
modified risk tobacco products. Such regulations or guidance
shall--
``(A) establish minimum standards for scientific studies
needed prior to approval to show that a substantial reduction
in morbidity or mortality among individual tobacco users is
likely;
``(B) include validated biomarkers, intermediate clinical
endpoints, and other feasible outcome measures, as
appropriate;
``(C) establish minimum standards for post market studies,
that shall include regular and long-term assessments of
health outcomes and mortality, intermediate clinical
endpoints, consumer perception of harm reduction, and the
impact on quitting behavior and new use of tobacco products,
as appropriate;
``(D) establish minimum standards for required postmarket
surveillance, including ongoing assessments of consumer
perception; and
``(E) require that data from the required studies and
surveillance be made available to the Secretary prior to the
decision on renewal of a modified risk tobacco product.
``(2) Consultation.--The regulations or guidance issued
under paragraph (1) shall be developed in consultation with
the Institute of Medicine, and with the input of other
appropriate scientific and medical experts, on the design and
conduct of such studies and surveillance.
``(3) Revision.--The regulations or guidance under
paragraph (1) shall be revised on

[[Page S2070]]

a regular basis as new scientific information becomes
available.
``(4) New tobacco products.--Not later than 2 years after
the date of enactment of the Family Smoking Prevention and
Tobacco Control Act, the Secretary shall issue a regulation
or guidance that permits the filing of a single application
for any tobacco product that is a new tobacco product under
section 910 and for which the applicant seeks approval as a
modified risk tobacco product under this section.
``(m) Distributors.--No distributor may take any action,
after the date of enactment of the Family Smoking Prevention
and Tobacco Control Act, with respect to a tobacco product
that would reasonably be expected to result in consumers
believing that the tobacco product or its smoke may present a
lower risk of disease or is less harmful than one or more
commercially marketed tobacco products, or presents a reduced
exposure to, or does not contain or is free of, a substance
or substances.

``SEC. 912. JUDICIAL REVIEW.

``(a) Right To Review.--
``(1) In general.--Not later than 30 days after--
``(A) the promulgation of a regulation under section 907
establishing, amending, or revoking a tobacco product
standard; or
``(B) a denial of an application for approval under section
910(c),

any person adversely affected by such regulation or denial
may file a petition for judicial review of such regulation or
denial with the United States Court of Appeals for the
District of Columbia or for the circuit in which such person
resides or has their principal place of business.
``(2) Requirements.--
``(A) Copy of petition.--A copy of the petition filed under
paragraph (1) shall be transmitted by the clerk of the court
involved to the Secretary.
``(B) Record of proceedings.--On receipt of a petition
under subparagraph (A), the Secretary shall file in the court
in which such petition was filed--
``(i) the record of the proceedings on which the regulation
or order was based; and
``(ii) a statement of the reasons for the issuance of such
a regulation or order.
``(C) Definition of record.--In this section, the term
`record' means--
``(i) all notices and other matter published in the Federal
Register with respect to the regulation or order reviewed;
``(ii) all information submitted to the Secretary with
respect to such regulation or order;
``(iii) proceedings of any panel or advisory committee with
respect to such regulation or order;
``(iv) any hearing held with respect to such regulation or
order; and
``(v) any other information identified by the Secretary, in
the administrative proceeding held with respect to such
regulation or order, as being relevant to such regulation or
order.
``(b) Standard of Review.--Upon the filing of the petition
under subsection (a) for judicial review of a regulation or
order, the court shall have jurisdiction to review the
regulation or order in accordance with chapter 7 of title 5,
United States Code, and to grant appropriate relief,
including interim relief, as provided for in such chapter. A
regulation or denial described in subsection (a) shall be
reviewed in accordance with section 706(2)(A) of title 5,
United States Code.
``(c) Finality of Judgment.--The judgment of the court
affirming or setting aside, in whole or in part, any
regulation or order shall be final, subject to review by the
Supreme Court of the United States upon certiorari or
certification, as provided in section 1254 of title 28,
United States Code.
``(d) Other Remedies.--The remedies provided for in this
section shall be in addition to, and not in lieu of, any
other remedies provided by law.
``(e) Regulations and Orders Must Recite Basis in Record.--
To facilitate judicial review, a regulation or order issued
under section 906, 907, 908, 909, 910, or 916 shall contain a
statement of the reasons for the issuance of such regulation
or order in the record of the proceedings held in connection
with its issuance.

``SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS.

``The Secretary shall issue regulations to require that
retail establishments for which the predominant business is
the sale of tobacco products comply with any advertising
restrictions applicable to retail establishments accessible
to individuals under the age of 18.

``SEC. 914. JURISDICTION OF AND COORDINATION WITH THE FEDERAL
TRADE COMMISSION.

``(a) Jurisdiction.--
``(1) In general.--Except where expressly provided in this
chapter, nothing in this chapter shall be construed as
limiting or diminishing the authority of the Federal Trade
Commission to enforce the laws under its jurisdiction with
respect to the advertising, sale, or distribution of tobacco
products.
``(2) Enforcement.--Any advertising that violates this
chapter or a provision of the regulations referred to in
section 102 of the Family Smoking Prevention and Tobacco
Control Act, is an unfair or deceptive act or practice under
section 5(a) of the Federal Trade Commission Act and shall be
considered a violation of a rule promulgated under section 18
of that Act.
``(b) Coordination.--With respect to the requirements of
section 4 of the Federal Cigarette Labeling and Advertising
Act and section 3 of the Comprehensive Smokeless Tobacco
Health Education Act of 1986--
``(1) the Chairman of the Federal Trade Commission shall
coordinate with the Secretary concerning the enforcement of
such Act as such enforcement relates to unfair or deceptive
acts or practices in the advertising of cigarettes or
smokeless tobacco; and
``(2) the Secretary shall consult with the Chairman of such
Commission in revising the label statements and requirements
under such sections.

``SEC. 915. CONGRESSIONAL REVIEW PROVISIONS.

``In accordance with section 801 of title 5, United States
Code, Congress shall review, and may disapprove, any rule
under this chapter that is subject to section 801. This
section and section 801 do not apply to the final rule
referred to in paragraphs (1) and (2) of section 102(a) of
the Family Smoking Prevention and Tobacco Control Act.

``SEC. 916. REGULATION REQUIREMENT.

``(a) Testing, Reporting, and Disclosure.--Not later than
24 months after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act, the Secretary, acting
through the Commissioner of Food and Drugs, shall promulgate
regulations under this Act that meet the requirements of
subsection (b).
``(b) Contents of Rules.--The regulations promulgated under
subsection (a) shall require testing and reporting of tobacco
product constituents, ingredients, and additives, including
smoke constituents, by brand and sub-brand that the Secretary
determines should be tested to protect the public health. The
regulations may require that tobacco product manufacturers,
packagers, or importers make disclosures relating to the
results of the testing of tar and nicotine through labels or
advertising or other appropriate means, and make disclosures
regarding the results of the testing of other constituents,
including smoke constituents, ingredients, or additives, that
the Secretary determines should be disclosed to the public to
protect the public health and will not mislead consumers
about the risk of tobacco related disease.
``(c) Authority.--The Food and Drug Administration shall
have the authority under this chapter to conduct or to
require the testing, reporting, or disclosure of tobacco
product constituents, including smoke constituents.

``SEC. 917. PRESERVATION OF STATE AND LOCAL AUTHORITY.

``(a) In General.--
``(1) Preservation.--Except as provided in paragraph
(2)(A), nothing in this chapter, or rules promulgated under
this chapter, shall be construed to limit the authority of a
Federal agency (including the Armed Forces), a State or
political subdivision of a State, or the government of an
Indian tribe to enact, adopt, promulgate, and enforce any
law, rule, regulation, or other measure with respect to
tobacco products that is in addition to, or more stringent
than, requirements established under this chapter, including
a law, rule, regulation, or other measure relating to or
prohibiting the sale, distribution, possession, exposure to,
access to, advertising and promotion of, or use of tobacco
products by individuals of any age, information reporting to
the State, or measures relating to fire safety standards for
tobacco products. No provision of this chapter shall limit or
otherwise affect any State, Tribal, or local taxation of
tobacco products.
``(2) Preemption of certain state and local requirements.--
``(A) In general.--No State or political subdivision of a
State may establish or continue in effect with respect to a
tobacco product any requirement which is different from, or
in addition to, any requirement under the provisions of this
chapter relating to tobacco product standards, premarket
approval, adulteration, misbranding, labeling, registration,
good manufacturing standards, or modified risk tobacco
products.
``(B) Exception.--Subparagraph (A) does not apply to
requirements relating to the sale, distribution, possession,
information reporting to the State, exposure to, access to,
the advertising and promotion of, or use of, tobacco products
by individuals of any age, or relating to fire safety
standards for tobacco products. Information disclosed to a
State under subparagraph (A) that is exempt from disclosure
under section 552(b)(4) of title 5, United States Code, shall
be treated as a trade secret and confidential information by
the State.
``(b) Rule of Construction Regarding Product Liability.--No
provision of this chapter relating to a tobacco product shall
be construed to modify or otherwise affect any action or the
liability of any person under the product liability law of
any State.

``SEC. 918. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.

``(a) Establishment.--Not later than 1 year after the date
of enactment of the Family Smoking Prevention and Tobacco
Control Act, the Secretary shall establish an 11-member
advisory committee, to be known as the `Tobacco Products
Scientific Advisory Committee' (in this section referred to
as the `Advisory Committee').
``(b) Membership.--
``(1) In general.--
``(A) Members.--The Secretary shall appoint as members of
the Tobacco Products Scientific Advisory Committee
individuals who are technically qualified by training and

[[Page S2071]]

experience in the medicine, medical ethics, science, or
technology involving the manufacture, evaluation, or use of
tobacco products, who are of appropriately diversified
professional backgrounds. The committee shall be composed
of--
``(i) 7 individuals who are physicians, dentists,
scientists, or health care professionals practicing in the
area of oncology, pulmonology, cardiology, toxicology,
pharmacology, addiction, or any other relevant specialty;
``(ii) 1 individual who is an officer or employee of a
State or local government or of the Federal Government;
``(iii) 1 individual as a representative of the general
public;
``(iv) 1 individual as a representative of the interests in
the tobacco manufacturing industry; and
``(v) 1 individual as a representative of the interests of
the tobacco growers.
``(B) Nonvoting members.--The members of the committee
appointed under clauses (iv) and (v) of subparagraph (A)
shall serve as consultants to those described in clauses (i)
through (iii) of subparagraph (A) and shall be nonvoting
representatives.
``(2) Limitation.--The Secretary may not appoint to the
Advisory Committee any individual who is in the regular full-
time employ of the Food and Drug Administration or any agency
responsible for the enforcement of this Act. The Secretary
may appoint Federal officials as ex officio members.
``(3) Chairperson.--The Secretary shall designate 1 of the
members of the Advisory Committee to serve as chairperson.
``(c) Duties.--The Tobacco Products Scientific Advisory
Committee shall provide advice, information, and
recommendations to the Secretary--
``(1) as provided in this chapter;
``(2) on the effects of the alteration of the nicotine
yields from tobacco products;
``(3) on whether there is a threshold level below which
nicotine yields do not produce dependence on the tobacco
product involved; and
``(4) on its review of other safety, dependence, or health
issues relating to tobacco products as requested by the
Secretary.
``(d) Compensation; Support; FACA.--
``(1) Compensation and travel.--Members of the Advisory
Committee who are not officers or employees of the United
States, while attending conferences or meetings of the
committee or otherwise engaged in its business, shall be
entitled to receive compensation at rates to be fixed by the
Secretary, which may not exceed the daily equivalent of the
rate in effect under the Senior Executive Schedule under
section 5382 of title 5, United States Code, for each day
(including travel time) they are so engaged; and while so
serving away from their homes or regular places of business
each member may be allowed travel expenses, including per
diem in lieu of subsistence, as authorized by section 5703 of
title 5, United States Code, for persons in the Government
service employed intermittently.
``(2) Administrative support.--The Secretary shall furnish
the Advisory Committee clerical and other assistance.
``(3) Nonapplication of faca.--Section 14 of the Federal
Advisory Committee Act does not apply to the Advisory
Committee.
``(e) Proceedings of Advisory Panels and Committees.--The
Advisory Committee shall make and maintain a transcript of
any proceeding of the panel or committee. Each such panel and
committee shall delete from any transcript made under this
subsection information which is exempt from disclosure under
section 552(b) of title 5, United States Code.

``SEC. 919. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE.

``The Secretary shall--
``(1) at the request of the applicant, consider designating
nicotine replacement products as fast track research and
approval products within the meaning of section 506;
``(2) consider approving the extended use of nicotine
replacement products (such as nicotine patches, nicotine gum,
and nicotine lozenges) for the treatment of tobacco
dependence; and
``(3) review and consider the evidence for additional
indications for nicotine replacement products, such as for
craving relief or relapse prevention.

``SEC. 920. USER FEE.

``(a) Establishment of Quarterly User Fee.--The Secretary
shall assess a quarterly user fee with respect to every
quarter of each fiscal year commencing fiscal year 2008,
calculated in accordance with this section, upon each
manufacturer and importer of tobacco products subject to this
chapter.
``(b) Funding of FDA Regulation of Tobacco Products.--The
Secretary shall make user fees collected pursuant to this
section available to pay, in each fiscal year, for the costs
of the activities of the Food and Drug Administration related
to the regulation of tobacco products under this chapter.
``(c) Assessment of User Fee.--
``(1) Amount of assessment.--Except as provided in
paragraph (4), the total user fees assessed each year
pursuant to this section shall be sufficient, and shall not
exceed what is necessary, to pay for the costs of the
activities described in subsection (b) for each fiscal year.
``(2) Allocation of assessment by class of tobacco
products.--
``(A) In general.--Subject to paragraph (3), the total user
fees assessed each fiscal year with respect to each class of
importers and manufacturers shall be equal to an amount that
is the applicable percentage of the total costs of activities
of the Food and Drug Administration described in subsection
(b).
``(B) Applicable percentage.--For purposes of subparagraph
(A), the applicable percentage for a fiscal year shall be the
following:
``(i) 92.07 percent shall be assessed on manufacturers and
importers of cigarettes;
``(ii) 0.05 percent shall be assessed on manufacturers and
importers of little cigars;
``(iii) 7.15 percent shall be assessed on manufacturers and
importers of cigars other than little cigars;
``(iv) 0.43 percent shall be assessed on manufacturers and
importers of snuff;
``(v) 0.10 percent shall be assessed on manufacturers and
importers of chewing tobacco;
``(vi) 0.06 percent shall be assessed on manufacturers and
importers of pipe tobacco; and
``(vii) 0.14 percent shall be assessed on manufacturers and
importers of roll-your-own tobacco.
``(3) Distribution of fee shares of manufacturers and
importers exempt from user fee.--Where a class of tobacco
products is not subject to a user fee under this section, the
portion of the user fee assigned to such class under
paragraph (2) shall be allocated by the Secretary on a pro
rata basis among the classes of tobacco products that are
subject to a user fee under this section. Such pro rata
allocation for each class of tobacco products that is subject
to a user fee under this section shall be the quotient of--
``(A) the percentage assigned to such class under paragraph
(2); divided by
``(B) the sum of the percentages assigned to all classes of
tobacco products subject to this section.
``(4) Annual limit on assessment.--The total assessment
under this section--
``(A) for fiscal year 2008 shall be $85,000,000;
``(B) for fiscal year 2009 shall be $175,000,000;
``(C) for fiscal year 2010 shall be $300,000,000; and
``(D) for each subsequent fiscal year, shall not exceed the
limit on the assessment imposed during the previous fiscal
year, as adjusted by the Secretary (after notice, published
in the Federal Register) to reflect the greater of--
``(i) the total percentage change that occurred in the
Consumer Price Index for all urban consumers (all items;
United States city average) for the 12-month period ending on
June 30 preceding the fiscal year for which fees are being
established; or
``(ii) the total percentage change for the previous fiscal
year in basic pay under the General Schedule in accordance
with section 5332 of title 5, United States Code, as adjusted
by any locality-based comparability payment pursuant to
section 5304 of such title for Federal employees stationed in
the District of Columbia.
``(5) Timing of user fee assessment.--The Secretary shall
notify each manufacturer and importer of tobacco products
subject to this section of the amount of the quarterly
assessment imposed on such manufacturer or importer under
subsection (f) during each quarter of each fiscal year. Such
notifications shall occur not earlier than 3 months prior to
the end of the quarter for which such assessment is made, and
payments of all assessments shall be made not later than 60
days after each such notification.
``(d) Determination of User Fee by Company Market Share.--
``(1) In general.--The user fee to be paid by each
manufacturer or importer of a given class of tobacco products
shall be determined in each quarter by multiplying--
``(A) such manufacturer's or importer's market share of
such class of tobacco products; by
``(B) the portion of the user fee amount for the current
quarter to be assessed on manufacturers and importers of such
class of tobacco products as determined under subsection (e).
``(2) No fee in excess of market share.--No manufacturer or
importer of tobacco products shall be required to pay a user
fee in excess of the market share of such manufacturer or
importer.
``(e) Determination of Volume of Domestic Sales.--
``(1) In general.--The calculation of gross domestic volume
of a class of tobacco product by a manufacturer or importer,
and by all manufacturers and importers as a group, shall be
made by the Secretary using information provided by
manufacturers and importers pursuant to subsection (f), as
well as any other relevant information provided to or
obtained by the Secretary.
``(2) Measurement.--For purposes of the calculations under
this subsection and the information provided under subsection
(f) by the Secretary, gross domestic volume shall be measured
by--
``(A) in the case of cigarettes, the number of cigarettes
sold;
``(B) in the case of little cigars, the number of little
cigars sold;
``(C) in the case of large cigars, the number of cigars
weighing more than 3 pounds per thousand sold; and
``(D) in the case of other classes of tobacco products, in
terms of number of pounds, or fraction thereof, of these
products sold.
``(f) Measurement of Gross Domestic Volume.--
``(1) In general.--Each tobacco product manufacturer and
importer shall submit to the Secretary a certified copy of
each of the

[[Page S2072]]

returns or forms described by this paragraph that are
required to be filed with a Government agency on the same
date that those returns or forms are required to be filed
with such agency. The returns and forms described by this
paragraph are those returns and forms related to the removal,
as defined by section 5702(j) of the Internal Revenue Code of
1986, of tobacco products into domestic commerce or the
payment of the taxes imposed under chapter 52 of such Code.
``(2) Penalties.--Any person that knowingly fails to
provide information required under this subsection or that
provides false information under this subsection shall be
subject to the penalties described in section 1001 of title
18, United States Code. In addition, such person may be
subject to a civil penalty in an amount not to exceed 2
percent of the value of the kind of tobacco products
manufactured or imported by such person during the applicable
quarter, as determined by the Secretary.
``(h) Effective Date.--The user fees prescribed by this
section shall be assessed in fiscal year 2008, based on
domestic sales of tobacco products during fiscal year 2007
and shall be assessed in each fiscal year thereafter.''.

SEC. 102. FINAL RULE.

(a) Cigarettes and Smokeless Tobacco.--
(1) In general.--Not later than 30 days after the date of
enactment of this Act, the Secretary of Health and Human
Services shall publish in the Federal Register a final rule
regarding cigarettes and smokeless tobacco, which is hereby
deemed to be in compliance with the Administrative Procedures
Act and other applicable law.
(2) Contents of rule.--Except as provided in this
subsection, the final rule published under paragraph (1),
shall be identical in its provisions to part 897 of the
regulations promulgated by the Secretary of Health and Human
Services in the August 28, 1996, issue of the Federal
Register (61 Fed. Reg., 44615-44618). Such rule shall--
(A) provide for the designation of jurisdictional authority
that is in accordance with this subsection;
(B) strike Subpart C--Labels and section 897.32(c); and
(C) become effective not later than 1 year after the date
of enactment of this Act.
(3) Amendments to rule.--Prior to making amendments to the
rule published under paragraph (1), the Secretary shall
promulgate a proposed rule in accordance with the
Administrative Procedures Act.
(4) Rule of construction.--Except as provided in paragraph
(3), nothing in this section shall be construed to limit the
authority of the Secretary to amend, in accordance with the
Administrative Procedures Act, the regulation promulgated
pursuant to this section.
(b) Limitation on Advisory Opinions.--As of the date of
enactment of this Act, the following documents issued by the
Food and Drug Administration shall not constitute advisory
opinions under section 10.85(d)(1) of title 21, Code of
Federal Regulations, except as they apply to tobacco
products, and shall not be cited by the Secretary of Health
and Human Services or the Food and Drug Administration as
binding precedent:
(1) The preamble to the proposed rule in the document
entitled ``Regulations Restricting the Sale and Distribution
of Cigarettes and Smokeless Tobacco Products to Protect
Children and Adolescents'' (60 Fed. Reg. 41314-41372 (August
11, 1995)).
(2) The document entitled ``Nicotine in Cigarettes and
Smokeless Tobacco Products is a Drug and These Products Are
Nicotine Delivery Devices Under the Federal Food, Drug, and
Cosmetic Act'' (60 Fed. Reg. 41453-41787 (August 11, 1995)).
(3) The preamble to the final rule in the document entitled
``Regulations Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco to Protect Children and
Adolescents'' (61 Fed. Reg. 44396-44615 (August 28, 1996)).
(4) The document entitled ``Nicotine in Cigarettes and
Smokeless Tobacco is a Drug and These Products are Nicotine
Delivery Devices Under the Federal Food, Drug, and Cosmetic
Act; Jurisdictional Determination'' (61 Fed. Reg. 44619-45318
(August 28, 1996)).

SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GENERAL
PROVISIONS.

(a) Amendment of Federal Food, Drug, and Cosmetic Act.--
Except as otherwise expressly provided, whenever in this
section an amendment is expressed in terms of an amendment
to, or repeal of, a section or other provision, the reference
is to a section or other provision of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.).
(b) Section 301.--Section 301 (21 U.S.C. 331) is amended--
(1) in subsection (a), by inserting ``tobacco product,''
after ``device,'';
(2) in subsection (b), by inserting ``tobacco product,''
after ``device,'';
(3) in subsection (c), by inserting ``tobacco product,''
after ``device,'';
(4) in subsection (e) (as amended by sections 2(c) and 3(b)
of the Dietary Supplement and Nonprescription Drug Consumer
Protection Act (Public Law 109-462; 120 Stat. 3472)), by
inserting ``, or 909'' before ``or the refusal to permit
access to'';
(5) in subsection (g), by inserting ``tobacco product,''
after ``device,'';
(6) in subsection (h), by inserting ``tobacco product,''
after ``device,'';
(7) in subsection (j), by striking ``708, or 721'' and
inserting ``708, 721, 904, 905, 906, 907, 908, 909, or
section 921(b)'';
(8) in subsection (k), by inserting ``tobacco product,''
after ``device,'';
(9) by striking subsection (p) and inserting the following:
``(p) The failure to register in accordance with section
510 or 905, the failure to provide any information required
by section 510(j), 510(k), 905(i), or 905(j), or the failure
to provide a notice required by section 510(j)(2) or
905(i)(2).'';
(10) by striking subsection (q)(1) and inserting the
following:
``(q)(1) The failure or refusal--
``(A) to comply with any requirement prescribed under
section 518, 520(g), 903(b), or 908;
``(B) to furnish any notification or other material or
information required by or under section 519, 520(g), 904,
909, or section 921; or
``(C) to comply with a requirement under section 522 or
913.'';
(11) in subsection (q)(2), by striking ``device,'' and
inserting ``device or tobacco product,'';
(12) in subsection (r), by inserting ``or tobacco product''
after the term ``device'' each time that such term appears;
and
(13) by adding at the end (as amended by section 4(a) of
the Dietary Supplement and Nonprescription Drug Consumer
Protection Act (Public Law 109-462; 120 Stat. 3475)) the
following:
``(jj) The sale of tobacco products in violation of a no-
tobacco-sale order issued under section 303(f).
``(kk) The introduction or delivery for introduction into
interstate commerce of a tobacco product in violation of
section 911.
``(ll)(1) Forging, counterfeiting, simulating, or falsely
representing, or without proper authority using any mark,
stamp (including tax stamp), tag, label, or other
identification device upon any tobacco product or container
or labeling thereof so as to render such tobacco product a
counterfeit tobacco product.
``(2) Making, selling, disposing of, or keeping in
possession, control, or custody, or concealing any punch,
die, plate, stone, or other item that is designed to print,
imprint, or reproduce the trademark, trade name, or other
identifying mark, imprint, or device of another or any
likeness of any of the foregoing upon any tobacco product or
container or labeling thereof so as to render such tobacco
product a counterfeit tobacco product.
``(3) The doing of any act that causes a tobacco product to
be a counterfeit tobacco product, or the sale or dispensing,
or the holding for sale or dispensing, of a counterfeit
tobacco product.
``(mm) The charitable distribution of tobacco products.
``(nn) The failure of a manufacturer or distributor to
notify the Attorney General of their knowledge of tobacco
products used in illicit trade.''.
(c) Section 303.--Section 303 (21 U.S.C. 333(f)) is amended
by redesignating the subsection that follows subsection (e)
as subsection (f) and in subsection (f) (as so
redesignated)--
(1) in paragraph (1)(A), by inserting ``or tobacco
products'' after ``devices'';
(2) in paragraph (2)(C), by striking ``paragraph (3)(A)''
and inserting ``paragraph (4)(A)'';
(3) by redesignating paragraphs (3), (4), and (5) as
paragraphs (4), (5), and (6), and inserting after paragraph
(2) the following:
``(3) If the Secretary finds that a person has committed
repeated violations of restrictions promulgated under section
906(d) at a particular retail outlet then the Secretary may
impose a no-tobacco-sale order on that person prohibiting the
sale of tobacco products in that outlet. A no-tobacco-sale
order may be imposed with a civil penalty under paragraph
(1).'';
(4) in paragraph (4) as so redesignated--
(A) in subparagraph (A)--
(i) by striking ``assessed'' the first time it appears and
inserting ``assessed, or a no-tobacco-sale order may be
imposed,''; and
(ii) by striking ``penalty'' and inserting ``penalty, or
upon whom a no-tobacco-order is to be imposed,'';
(B) in subparagraph (B)--
(i) by inserting after ``penalty,'' the following: ``or the
period to be covered by a no-tobacco-sale order,''; and
(ii) by adding at the end the following: ``A no-tobacco-
sale order permanently prohibiting an individual retail
outlet from selling tobacco products shall include provisions
that allow the outlet, after a specified period of time, to
request that the Secretary compromise, modify, or terminate
the order.''; and
(C) by adding at the end the following:
``(D) The Secretary may compromise, modify, or terminate,
with or without conditions, any no-tobacco-sale order.'';
(5) in paragraph (5) as so redesignated--
(A) by striking ``(3)(A)'' as redesignated, and inserting
``(4)(A)'';
(B) by inserting ``or the imposition of a no-tobacco-sale
order'' after the term ``penalty'' the first 2 places such
term appears; and
(C) by striking ``issued.'' and inserting ``issued, or on
which the no-tobacco-sale order was imposed, as the case may
be.''; and
(6) in paragraph (6), as so redesignated, by striking the
term ``paragraph (4)'' each place such term appears and
inserting ``paragraph (5)''.
(d) Section 304.--Section 304 (21 U.S.C. 334) is amended--
(1) in subsection (a)(2)--
(A) by striking ``and'' before ``(D)''; and

[[Page S2073]]

(B) by striking ``device.'' and inserting the following:
``device, and (E) Any adulterated or misbranded tobacco
product.'';
(2) in subsection (d)(1), by inserting ``tobacco product,''
after ``device,'';
(3) in subsection (g)(1), by inserting ``or tobacco
product'' after the term ``device'' each place such term
appears; and
(4) in subsection (g)(2)(A), by inserting ``or tobacco
product'' after the term ``device'' each place such term
appears.
(e) Section 702.--Section 702(a) (21 U.S.C. 372(a)) is
amended by adding at the end of paragraph (1) the following:
``For a tobacco product, to the extent feasible, the
Secretary shall contract with the States in accordance with
this paragraph to carry out inspections of retailers within
that State in connection with the enforcement of this Act.''.
(f) Section 703.--Section 703 (21 U.S.C. 373) is amended--
(1) by inserting ``tobacco product,'' after the term
``device,'' each place such term appears; and
(2) by inserting ``tobacco products,'' after the term
``devices,'' each place such term appears.
(g) Section 704.--Section 704 (21 U.S.C. 374) is amended--
(1) in subsection (a)(1)(A), by inserting ``tobacco
products,'' after the term ``devices,'' each place such term
appears;
(2) in subsection (a)(1)(B), by inserting ``or tobacco
product'' after the term ``restricted devices'' each place
such term appears; and
(3) in subsection (b), by inserting ``tobacco product,''
after ``device,''.
(h) Section 705.--Section 705(b) (21 U.S.C. 375(b)) is
amended by inserting ``tobacco products,'' after
``devices,''.
(i) Section 709.--Section 709 (21 U.S.C. 379) is amended by
inserting ``tobacco product,'' after ``device,''.
(j) Section 801.--Section 801 (21 U.S.C. 381) is amended--
(1) in subsection (a)--
(A) by inserting ``tobacco products,'' after the term
``devices,'' the first time such term appears;
(B) by inserting ``or section 905(j)'' after ``section
510''; and
(C) by striking the term ``drugs or devices'' each time
such term appears and inserting ``drugs, devices, or tobacco
products'';
(2) in subsection (e)(1), by inserting ``tobacco product,''
after ``device,''; and
(3) by adding at the end the following:
``(p)(1) Not later than 2 years after the date of enactment
of the Family Smoking Prevention and Tobacco Control Act, and
annually thereafter, the Secretary shall submit to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House
of Representatives, a report regarding--
``(A) the nature, extent, and destination of United States
tobacco product exports that do not conform to tobacco
product standards established pursuant to this Act;
``(B) the public health implications of such exports,
including any evidence of a negative public health impact;
and
``(C) recommendations or assessments of policy alternatives
available to Congress and the Executive Branch to reduce any
negative public health impact caused by such exports.
``(2) The Secretary is authorized to establish appropriate
information disclosure requirements to carry out this
subsection.''.
(k) Section 1003.--Section 1003(d)(2)(C) (as redesignated
by section 101(b)) is amended--
(1) by striking ``and'' after ``cosmetics,''; and
(2) inserting ``, and tobacco products'' after ``devices''.
(l) Guidance and Effective Dates.--
(1) In general.--The Secretary of Health and Human Services
shall issue guidance--
(A) defining the term ``repeated violation'', as used in
section 303(f) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 333(f)) as amended by subsection (c), by
identifying the number of violations of particular
requirements over a specified period of time at a particular
retail outlet that constitute a repeated violation;
(B) providing for timely and effective notice to the
retailer of each alleged violation at a particular retail
outlet;
(C) providing for an expedited procedure for the
administrative appeal of an alleged violation;
(D) providing that a person may not be charged with a
violation at a particular retail outlet unless the Secretary
has provided notice to the retailer of all previous
violations at that outlet;
(E) establishing a period of time during which, if there
are no violations by a particular retail outlet, that outlet
will not be considered to have been the site of repeated
violations when the next violation occurs; and
(F) providing that good faith reliance on the presentation
of a false government issued photographic identification that
contains a date of birth does not constitute a violation of
any minimum age requirement for the sale of tobacco products
if the retailer has taken effective steps to prevent such
violations, including--
(i) adopting and enforcing a written policy against sales
to minors;
(ii) informing its employees of all applicable laws;
(iii) establishing disciplinary sanctions for employee
noncompliance; and
(iv) requiring its employees to verify age by way of
photographic identification or electronic scanning device.
(2) General effective date.--The amendments made by
subsection (c), other than the amendment made by paragraph
(2) of such subsection, shall take effect upon the issuance
of guidance described in paragraph (1).
(3) Special effective date.--The amendments made by
paragraph (2) of subsection (c) shall take effect on the date
of enactment of this Act.

TITLE II--TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT
DISCLOSURE

SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS.

Section 4 of the Federal Cigarette Labeling and Advertising
Act (15 U.S.C. 1333) is amended to read as follows:

``SEC. 4. LABELING.

``(a) Label Requirements.--
``(1) In general.--It shall be unlawful for any person to
manufacture, package, sell, offer to sell, distribute, or
import for sale or distribution within the United States any
cigarettes the package of which fails to bear, in accordance
with the requirements of this section, one of the following
labels:
``WARNING: Cigarettes are addictive'.
``WARNING: Tobacco smoke can harm your children'.
``WARNING: Cigarettes cause fatal lung disease'.
``WARNING: Cigarettes cause cancer'.
``WARNING: Cigarettes cause strokes and heart disease'.
``WARNING: Smoking during pregnancy can harm your baby'.
``WARNING: Smoking can kill you'.
``WARNING: Tobacco smoke causes fatal lung disease in non-
smokers'.
``WARNING: Quitting smoking now greatly reduces serious
risks to your health'.
``(2) Placement; typography; etc.--
``(A) In general.--Each label statement required by
paragraph (1) shall be located in the upper portion of the
front and rear panels of the package, directly on the package
underneath the cellophane or other clear wrapping. Except as
provided in subparagraph (B), each label statement shall
comprise at least the top 30 percent of the front and rear
panels of the package. The word `WARNING' shall appear in
capital letters and all text shall be in conspicuous and
legible 17-point type, unless the text of the label statement
would occupy more than 70 percent of such area, in which case
the text may be in a smaller conspicuous and legible type
size, provided that at least 60 percent of such area is
occupied by required text. The text shall be black on a white
background, or white on a black background, in a manner that
contrasts, by typography, layout, or color, with all other
printed material on the package, in an alternating fashion
under the plan submitted under subsection (b)(4).
``(B) Hinged lid boxes.--For any cigarette brand package
manufactured or distributed before January 1, 2000, which
employs a hinged lid style (if such packaging was used for
that brand in commerce prior to June 21, 1997), the label
statement required by paragraph (1) shall be located on the
hinged lid area of the package, even if such area is less
than 25 percent of the area of the front panel. Except as
provided in this paragraph, the provisions of this subsection
shall apply to such packages.
``(3) Does not apply to foreign distribution.--The
provisions of this subsection do not apply to a tobacco
product manufacturer or distributor of cigarettes which does
not manufacture, package, or import cigarettes for sale or
distribution within the United States.
``(4) Applicability to retailers.--A retailer of cigarettes
shall not be in violation of this subsection for packaging
that is supplied to the retailer by a tobacco product
manufacturer, importer, or distributor and is not altered by
the retailer in a way that is material to the requirements of
this subsection except that this paragraph shall not relieve
a retailer of liability if the retailer sells or distributes
tobacco products that are not labeled in accordance with this
subsection.
``(b) Advertising Requirements.--
``(1) In general.--It shall be unlawful for any tobacco
product manufacturer, importer, distributor, or retailer of
cigarettes to advertise or cause to be advertised within the
United States any cigarette unless its advertising bears, in
accordance with the requirements of this section, one of the
labels specified in subsection (a) of this section.
``(2) Typography, etc.--Each label statement required by
subsection (a) of this section in cigarette advertising shall
comply with the standards set forth in this paragraph. For
press and poster advertisements, each such statement and
(where applicable) any required statement relating to tar,
nicotine, or other constituent (including a smoke
constituent) yield shall comprise at least 20 percent of the
area of the advertisement and shall appear in a conspicuous
and prominent format and location at the top of each
advertisement within the trim area. The Secretary may revise
the required type sizes in such area in such manner as the
Secretary determines appropriate. The word `WARNING' shall
appear in capital letters, and each label statement shall
appear in conspicuous and legible type. The text of the label
statement shall be black if the background is white and white
if the background is black, under the plan submitted under
paragraph (4) of this subsection. The label statements shall
be enclosed by a rectangular border that is the same color as
the letters of the statements and that is the width of the
first downstroke of the capital `W' of the word

[[Page S2074]]

`WARNING' in the label statements. The text of such label
statements shall be in a typeface pro rata to the following
requirements: 45-point type for a whole-page broadsheet
newspaper advertisement; 39-point type for a half-page
broadsheet newspaper advertisement; 39-point type for a
whole-page tabloid newspaper advertisement; 27-point type for
a half-page tabloid newspaper advertisement; 31.5-point type
for a double page spread magazine or whole-page magazine
advertisement; 22.5-point type for a 28 centimeter by 3
column advertisement; and 15-point type for a 20 centimeter
by 2 column advertisement. The label statements shall be in
English, except that in the case of--
``(A) an advertisement that appears in a newspaper,
magazine, periodical, or other publication that is not in
English, the statements shall appear in the predominant
language of the publication; and
``(B) in the case of any other advertisement that is not in
English, the statements shall appear in the same language as
that principally used in the advertisement.
``(3) Matchbooks.--Notwithstanding paragraph (2), for
matchbooks (defined as containing not more than 20 matches)
customarily given away with the purchase of tobacco products,
each label statement required by subsection (a) may be
printed on the inside cover of the matchbook.
``(4) Adjustment by secretary.--The Secretary may, through
a rulemaking under section 553 of title 5, United States
Code, adjust the format and type sizes for the label
statements required by this section or the text, format, and
type sizes of any required tar, nicotine yield, or other
constituent (including smoke constituent) disclosures, or to
establish the text, format, and type sizes for any other
disclosures required under the Federal Food, Drug, and
Cosmetic Act. The text of any such label statements or
disclosures shall be required to appear only within the 20
percent area of cigarette advertisements provided by
paragraph (2) of this subsection. The Secretary shall
promulgate regulations which provide for adjustments in the
format and type sizes of any text required to appear in such
area to ensure that the total text required to appear by law
will fit within such area.
``(c) Marketing Requirements.--
``(1) Random display.--The label statements specified in
subsection (a)(1) shall be randomly displayed in each 12-
month period, in as equal a number of times as is possible on
each brand of the product and be randomly distributed in all
areas of the United States in which the product is marketed
in accordance with a plan submitted by the tobacco product
manufacturer, importer, distributor, or retailer and approved
by the Secretary.
``(2) Rotation.--The label statements specified in
subsection (a)(1) shall be rotated quarterly in alternating
sequence in advertisements for each brand of cigarettes in
accordance with a plan submitted by the tobacco product
manufacturer, importer, distributor, or retailer to, and
approved by, the Secretary.
``(3) Review.--The Secretary shall review each plan
submitted under paragraph (2) and approve it if the plan--
``(A) will provide for the equal distribution and display
on packaging and the rotation required in advertising under
this subsection; and
``(B) assures that all of the labels required under this
section will be displayed by the tobacco product
manufacturer, importer, distributor, or retailer at the same
time.
``(4) Applicability to retailers.--This subsection and
subsection (b) apply to a retailer only if that retailer is
responsible for or directs the label statements required
under this section except that this paragraph shall not
relieve a retailer of liability if the retailer displays, in
a location open to the public, an advertisement that is not
labeled in accordance with the requirements of this
subsection and subsection (b).''.

SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING LABEL
STATEMENTS.

Section 4 of the Federal Cigarette Labeling and Advertising
Act (15 U.S.C. 1333), as amended by section 201, is further
amended by adding at the end the following:
``(d) Change in Required Statements.--The Secretary may, by
a rulemaking conducted under section 553 of title 5, United
States Code, adjust the format, type size, and text of any of
the label requirements, require color graphics to accompany
the text, increase the required label area from 30 percent up
to 50 percent of the front and rear panels of the package, or
establish the format, type size, and text of any other
disclosures required under the Federal Food, Drug, and
Cosmetic Act, if the Secretary finds that such a change would
promote greater public understanding of the risks associated
with the use of tobacco products.''.

SEC. 203. STATE REGULATION OF CIGARETTE ADVERTISING AND
PROMOTION.

Section 5 of the Federal Cigarette Labeling and Advertising
Act (15 U.S.C. 1334) is amended by adding at the end the
following:
``(c) Exception.--Notwithstanding subsection (b), a State
or locality may enact statutes and promulgate regulations,
based on smoking and health, that take effect after the
effective date of the Family Smoking Prevention and Tobacco
Control Act, imposing specific bans or restrictions on the
time, place, and manner, but not content, of the advertising
or promotion of any cigarettes.''.

SEC. 204. SMOKELESS TOBACCO LABELS AND ADVERTISING WARNINGS.

Section 3 of the Comprehensive Smokeless Tobacco Health
Education Act of 1986 (15 U.S.C. 4402) is amended to read as
follows:

``SEC. 3. SMOKELESS TOBACCO WARNING.

``(a) General Rule.--
``(1) It shall be unlawful for any person to manufacture,
package, sell, offer to sell, distribute, or import for sale
or distribution within the United States any smokeless
tobacco product unless the product package bears, in
accordance with the requirements of this Act, one of the
following labels:
``WARNING: This product can cause mouth cancer'.
``WARNING: This product can cause gum disease and tooth
loss'.
``WARNING: This product is not a safe alternative to
cigarettes'.
``WARNING: Smokeless tobacco is addictive'.
``(2) Each label statement required by paragraph (1) shall
be--
``(A) located on the 2 principal display panels of the
package, and each label statement shall comprise at least 30
percent of each such display panel; and
``(B) in 17-point conspicuous and legible type and in black
text on a white background, or white text on a black
background, in a manner that contrasts by typography, layout,
or color, with all other printed material on the package, in
an alternating fashion under the plan submitted under
subsection (b)(3), except that if the text of a label
statement would occupy more than 70 percent of the area
specified by subparagraph (A), such text may appear in a
smaller type size, so long as at least 60 percent of such
warning area is occupied by the label statement.
``(3) The label statements required by paragraph (1) shall
be introduced by each tobacco product manufacturer, packager,
importer, distributor, or retailer of smokeless tobacco
products concurrently into the distribution chain of such
products.
``(4) The provisions of this subsection do not apply to a
tobacco product manufacturer or distributor of any smokeless
tobacco product that does not manufacture, package, or import
smokeless tobacco products for sale or distribution within
the United States.
``(5) A retailer of smokeless tobacco products shall not be
in violation of this subsection for packaging that is
supplied to the retailer by a tobacco products manufacturer,
importer, or distributor and that is not altered by the
retailer unless the retailer offers for sale, sells, or
distributes a smokeless tobacco product that is not labeled
in accordance with this subsection.
``(b) Required Labels.--
``(1) It shall be unlawful for any tobacco product
manufacturer, packager, importer, distributor, or retailer of
smokeless tobacco products to advertise or cause to be
advertised within the United States any smokeless tobacco
product unless its advertising bears, in accordance with the
requirements of this section, one of the labels specified in
subsection (a).
``(2) Each label statement required by subsection (a) in
smokeless tobacco advertising shall comply with the standards
set forth in this paragraph. For press and poster
advertisements, each such statement and (where applicable)
any required statement relating to tar, nicotine, or other
constituent yield shall--
``(A) comprise at least 20 percent of the area of the
advertisement, and the warning area shall be delineated by a
dividing line of contrasting color from the advertisement;
and
``(B) the word `WARNING' shall appear in capital letters
and each label statement shall appear in conspicuous and
legible type. The text of the label statement shall be black
on a white background, or white on a black background, in an
alternating fashion under the plan submitted under paragraph
(3).
``(3)(A) The label statements specified in subsection
(a)(1) shall be randomly displayed in each 12-month period,
in as equal a number of times as is possible on each brand of
the product and be randomly distributed in all areas of the
United States in which the product is marketed in accordance
with a plan submitted by the tobacco product manufacturer,
importer, distributor, or retailer and approved by the
Secretary.
``(B) The label statements specified in subsection (a)(1)
shall be rotated quarterly in alternating sequence in
advertisements for each brand of smokeless tobacco product in
accordance with a plan submitted by the tobacco product
manufacturer, importer, distributor, or retailer to, and
approved by, the Secretary.
``(C) The Secretary shall review each plan submitted under
subparagraph (B) and approve it if the plan--
``(i) will provide for the equal distribution and display
on packaging and the rotation required in advertising under
this subsection; and
``(ii) assures that all of the labels required under this
section will be displayed by the tobacco product
manufacturer, importer, distributor, or retailer at the same
time.
``(D) This paragraph applies to a retailer only if that
retailer is responsible for or directs the label statements
under this section, unless the retailer displays in a
location open to the public, an advertisement that is not
labeled in accordance with the requirements of this
subsection.
``(c) Television and Radio Advertising.--It is unlawful to
advertise smokeless tobacco

[[Page S2075]]

on any medium of electronic communications subject to the
jurisdiction of the Federal Communications Commission.''.

SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT
WARNING LABEL STATEMENTS.

Section 3 of the Comprehensive Smokeless Tobacco Health
Education Act of 1986 (15 U.S.C. 4402), as amended by section
204, is further amended by adding at the end the following:
``(d) Authority To Revise Warning Label Statements.--The
Secretary may, by a rulemaking conducted under section 553 of
title 5, United States Code, adjust the format, type size,
and text of any of the label requirements, require color
graphics to accompany the text, increase the required label
area from 30 percent up to 50 percent of the front and rear
panels of the package, or establish the format, type size,
and text of any other disclosures required under the Federal
Food, Drug, and Cosmetic Act, if the Secretary finds that
such a change would promote greater public understanding of
the risks associated with the use of smokeless tobacco
products.''.

SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT
DISCLOSURE TO THE PUBLIC.

Section 4 of the Federal Cigarette Labeling and Advertising
Act (15 U.S.C. 1333), as amended by sections 201 and 202, is
further amended by adding at the end the following:
``(e) Tar, Nicotine, and Other Smoke Constituent
Disclosure.--
``(1) In general.--The Secretary shall, by a rulemaking
conducted under section 553 of title 5, United States Code,
determine (in the Secretary's sole discretion) whether
cigarette and other tobacco product manufacturers shall be
required to include in the area of each cigarette
advertisement specified by subsection (b) of this section, or
on the package label, or both, the tar and nicotine yields of
the advertised or packaged brand. Any such disclosure shall
be in accordance with the methodology established under such
regulations, shall conform to the type size requirements of
subsection (b) of this section, and shall appear within the
area specified in subsection (b) of this section.
``(2) Resolution of differences.--Any differences between
the requirements established by the Secretary under paragraph
(1) and tar and nicotine yield reporting requirements
established by the Federal Trade Commission shall be resolved
by a memorandum of understanding between the Secretary and
the Federal Trade Commission.
``(3) Cigarette and other tobacco product constituents.--In
addition to the disclosures required by paragraph (1), the
Secretary may, under a rulemaking conducted under section 553
of title 5, United States Code, prescribe disclosure
requirements regarding the level of any cigarette or other
tobacco product constituent including any smoke constituent.
Any such disclosure may be required if the Secretary
determines that disclosure would be of benefit to the public
health, or otherwise would increase consumer awareness of the
health consequences of the use of tobacco products, except
that no such prescribed disclosure shall be required on the
face of any cigarette package or advertisement. Nothing in
this section shall prohibit the Secretary from requiring such
prescribed disclosure through a cigarette or other tobacco
product package or advertisement insert, or by any other
means under the Federal Food, Drug, and Cosmetic Act.
``(4) Retailers.--This subsection applies to a retailer
only if that retailer is responsible for or directs the label
statements required under this section, except that this
subsection shall not relieve a retailer of liability if the
retailer sells or distributes tobacco products that are not
labeled in accordance with the requirements of subsection
(a).''.

TITLE III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS

SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPECTION.

Chapter IX of the Federal Food, Drug, and Cosmetic Act, as
added by section 101, is further amended by adding at the end
the following:

``SEC. 921. LABELING, RECORDKEEPING, RECORDS INSPECTION.

``(a) Origin Labeling.--The label, packaging, and shipping
containers of tobacco products for introduction or delivery
for introduction into interstate commerce in the United
States shall bear the statement `sale only allowed in the
United States.'
``(b) Regulations Concerning Recordkeeping for Tracking and
Tracing.--
``(1) In general.--Not later than 9 months after the date
of enactment of the Family Smoking Prevention and Tobacco
Control Act, the Secretary shall promulgate regulations
regarding the establishment and maintenance of records by any
person who manufactures, processes, transports, distributes,
receives, packages, holds, exports, or imports tobacco
products.
``(2) Inspection.--In promulgating the regulations
described in paragraph (1), the Secretary shall consider
which records are needed for inspection to monitor the
movement of tobacco products from the point of manufacture
through distribution to retail outlets to assist in
investigating potential illicit trade, smuggling or
counterfeiting of tobacco products.
``(3) Codes.--The Secretary may require codes on the labels
of tobacco products or other designs or devices for the
purpose of tracking or tracing the tobacco product through
the distribution system.
``(4) Size of business.--The Secretary shall take into
account the size of a business in promulgating regulations
under this section.
``(5) Recordkeeping by retailers.--The Secretary shall not
require any retailer to maintain records relating to
individual purchasers of tobacco products for personal
consumption.
``(c) Records Inspection.--If the Secretary has a
reasonable belief that a tobacco product is part of an
illicit trade or smuggling or is a counterfeit product, each
person who manufactures, processes, transports, distributes,
receives, holds, packages, exports, or imports tobacco
products shall, at the request of an officer or employee duly
designated by the Secretary, permit such officer or employee,
at reasonable times and within reasonable limits and in a
reasonable manner, upon the presentation of appropriate
credentials and a written notice to such person, to have
access to and copy all records (including financial records)
relating to such article that are needed to assist the
Secretary in investigating potential illicit trade, smuggling
or counterfeiting of tobacco products.
``(d) Knowledge of Illegal Transaction.--
``(1) Notification.--If the manufacturer or distributor of
a tobacco product has knowledge which reasonably supports the
conclusion that a tobacco product manufactured or distributed
by such manufacturer or distributor that has left the control
of such person may be or has been--
``(A) imported, exported, distributed or offered for sale
in interstate commerce by a person without paying duties or
taxes required by law; or
``(B) imported, exported, distributed or diverted for
possible illicit marketing,

the manufacturer or distributor shall promptly notify the
Attorney General of such knowledge.
``(2) Knowledge defined.--For purposes of this subsection,
the term `knowledge' as applied to a manufacturer or
distributor means--
``(A) the actual knowledge that the manufacturer or
distributor had; or
``(B) the knowledge which a reasonable person would have
had under like circumstances or which would have been
obtained upon the exercise of due care.''.

SEC. 302. STUDY AND REPORT.

(a) Study.--The Comptroller General of the United States
shall conduct a study of cross-border trade in tobacco
products to--
(1) collect data on cross-border trade in tobacco products,
including illicit trade and trade of counterfeit tobacco
products and make recommendations on the monitoring of such
trade;
(2) collect data on cross-border advertising (any
advertising intended to be broadcast, transmitted, or
distributed from the United States to another country) of
tobacco products and make recommendations on how to prevent
or eliminate, and what technologies could help facilitate the
elimination of, cross-border advertising.
(b) Report.--Not later than 18 months after the date of
enactment of this Act, the Comptroller General of the United
States shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives a report on the
study described in subsection (a).
______

By Mr. KENNEDY (for himself, Mr. Bond, Mr. akaka, Mr. Leahy, Mr.
Menendez, Mr. Craig, and Mr. Shelby):
S. 626 A bill to amend the Public Health Service Act to provide for
arthritis research and public health, and for other purposes; to the
Committee on Health, Education, Labor, and Pensions.
Mr. KENNEDY. Mr. President, it is a privilege to join Senator Bond in
introducing ``The Arthritis Prevention, Control and Cure Act.''
Our goal in this important initiative is to provide a strong federal
response to arthritis. Early diagnosis, treatment, and appropriate
management of arthritis can control its symptoms, improve the quality
of life of patients, and Federal action will improve the lives of the
family members and caregivers of those affected by the disease.
Arthritis exits in more than a hundred different forms. It's one of
the most devastating diseases impairing the health of the American
people. It's second only to heart disease as a cause of work
disability. It undermines everyday activities such as walking, dressing
and bathing for more than seven million Americans.
One out of very five adults in the United States suffers from some
form of arthritis. The number of patients in the U.S. with arthritis
will keep growing as the number of older Americans continues to
increase dramatically in the next few decades. Today, 8.7 million
adults, ages 18 through 44, have arthritis and millions of others are
at risk of developing the disease.
In fact, arthritis is one of the most prevalent chronic illnesses and
the

[[Page S2076]]

leading cause of disability among Americans over age 15. More than 40
percent of adults with arthritis are limited in their activities
because of their arthritis. By 2030, nearly 25 percent of the projected
United States adult population will have arthritis and these numbers
don't account for the current trends in obesity, which may contribute
to future cases of the disease.
It is an illness that affects all types of people in the U.S., not
just older Americans. Arthritis knows no boundaries. Men, women and
children are all afflicted with the disease. According to the Arthritis
Foundation, 24 million women and 17 million men have been diagnosed
with arthritis by their doctors. Women are still disproportionately
affected by the disease.
Nearly 3 out of every 1,000 American children are affected by
arthritis. The devastating effects of pediatric arthritis justifies
greater investment by the federal government in research and to
identify more effective treatments.
Special concerns are raised by juvenile arthritis because of its
impact on family relationships, school life, dating, sports and other
aspects active, growing youths. Teens and young adults entering the
workforce face even greater challenges.
Arthritis an other rheumatic diseases cost our economy $128 billion
annually, according to the Centers for Disease Control and Prevention.
In 2003, the cost was equivalent to 1.2 percent of the nation's gross
domestic product. $80 million of that amount were direct costs for
medical care and $47 million were indirect costs for lost earnings.
National medical costs attributed to arthritis grew by 24 percent
between 1997 and 2003, with an increase attributed to the growing
number of people affected with the disease.

In 1975, Congress enacted the National Arthritis Act to encourage
basic and clinical research, establish Multipurpose Arthritis Centers
and expand clinical knowledge of the illness. The act was successful in
implementing and continued funding of research and has led to important
advances in the control, treatment and prevention of the illness.
Early diagnosis, treatment and management can control symptoms and
improve the quality of life. Weight control and exercise can help lower
risks. Patient education, training and self-management also contribute
to greater control of these diseases. Innovative and increasingly
effective drug therapies, joint replacements, and other therapeutic
alternatives are being developed.
Despite much research identifying effective interventions, many of
them are not being used well enough and the inevitable result is
unnecessary loss of life, poorer health and poorer quality of life.
Our legislation will expand the effort to find new ways to prevent,
treat and care for patients with arthritis and related rheumatic
diseases.
It will enhance the National Arthritis Action Plan by providing
additional support to federal, state and private efforts to prevent and
manage arthritis. It will establish a National Arthritis Education and
Outreach Campaign to inform the health care profession and the public
about the most successful self-management strategies for controlling
the illness.
With greater coordination and intensification of federal research,
this bill will organize a National Arthritis and Rheumatic Diseases
Summit to look at the challenges and opportunities related to these
efforts.
In addition, the bill will provide greater attention to juvenile
arthritis research by offering planning grants for research specific to
juveniles and by prioritizing the activities that create better
understanding of the incidence and outcomes associated with juvenile
arthritis.
Finally the bill contains incentives to encourage health
professionals to enter the field of pediatric rheumatology by education
loan repayment and career development awards.
I urge my colleagues to support this public health initiative to
reduce the pain and disability of arthritis. Early diagnosis, effective
treatment and greater investment in research and prevention can help us
wage a stronger battle against one of the most widespread and
devastating conditions affecting our Nation.
______

By Mr. HARKIN (for himself, Mr. Smith, Mr. Specter, and Mr.
Martinez):
S. 627. A bill to amend the Juvenile Justice and Delinquency
Prevention Act of 1974 to improve the health and well-being of
maltreated infants and toddlers through the creation of a National
Court Teams Resource Center, to assist local Court Teams, and for other
purposes; to the Committee on the Judiciary.
Mr. HARKIN. Mr. President, I am honored to join with the
distinguished senior Senator from Oregon, Senator Smith, to introduce
the Safe Babies Act of 2007.
It is a tragic fact that America's child welfare system is failing
our most vulnerable. From birth to age five, children develop their
social, emotional, cognitive and moral capacities more rapidly than at
any other time in life. Early experiences and relationships are
absolutely critical to future development; they set the stage for how
well individuals learn, think, control their emotions, and relate to
others.
This critical period is a time of tremendous promise, but also a time
of great vulnerability. Unfortunately, infants and toddlers are
disproportionately affected by child abuse and neglect. Children
between birth and age three are twice as likely as older children to
become victims of maltreatment, and are three times more likely to be
placed in foster care. Abuse and neglect during this significant period
can lead to perilous developmental outcomes, including school failure,
delinquency and crime, substance abuse, and mental health problems.
Yet the current child welfare system does a particularly poor job of
serving infants and toddlers. Once in foster care, infants and toddlers
are more likely to be abused. And they stay in foster care longer than
older children. More than 40 percent of infants and toddlers involved
in a maltreatment investigation are developmentally delayed, yet only
10 percent of these young people currently receive treatment for
developmental problems.
A Federal review of 19 States' performance on child welfare outcomes
found that all of the States received failing grades on outcomes
related to providing adequate physical and mental health services.
Without intervention, we put our future generation at risk and
perpetuate the cycle of maltreatment. But we can alter these
developmental outcomes by ensuring that children are in safe, permanent
homes and have access to necessary mental and physical health care. The
Safe Babies Act authorizes funding for juvenile courts to create Court
Teams for the integrated handling of infant and toddler abuse and
neglect cases. By bringing together the legal, child welfare, and
children's services communities, we can promote the health and well-
being of our babies and toddlers.
First, this bill establishes a National Court Teams Resource Center.
This Resource Center would provide grants and technical assistance to
juvenile courts for the creation of local Court Teams to better handle
infant and toddler abuse and neglect cases. Few judges have all the
necessary knowledge about early childhood development and they
frequently lack resources in the community for services necessary for
young children. They are often frustrated by the piecemeal provision of
services and the overburdened child welfare system. To adequately serve
children, they need the expertise of child welfare workers, Guardians
Ad Litem, Court Appointed Special Advocates, substance abuse treatment
providers and mental health care providers. Court Teams bring together
this expertise. Through monthly case reviews, judges can coordinate
efforts by all members of the team to ensure efficient and effective
provision of services. The goal of these courts is to prevent multiple
placements for infants and toddlers in foster care, secure needed
services, and find a permanent home for these children as quickly as
possible.
Court Teams work with families in an effort to reunite children with
their parents. By bringing together multiple service providers, they
can facilitate opportunities for parents to learn to create a safe and
nurturing home environment. Court Teams ensure support for future
reunification only when the

[[Page S2077]]

parent is ready and able to step up to provide an appropriate and safe
environment. We know from research that each visit between a child and
birth parent triples the likelihood of achieving permanence. Through
the Court Teams, judges are able to coordinate education and
supervision so parents can visit their children and continue to nurture
a loving bond.
Although reunification with parents is the ultimate goal, when that
is not possible, Court Teams are also focusing on Plan B. By conducting
concurrent planning, Court Teams are more likely to find an appropriate
placement that will lead to permanency and minimize disruptions. By
supporting training for foster parents and newly reunified biological
parents, we can prevent children from being bounced around in the
foster care system.
Court Teams are also able to coordinate services for children. Judges
and child welfare services are able to collaborate to include necessary
medical and developmental interventions. By improving access to mental
health and substance abuse treatment for parents and children, Court
Teams make sure children are able to access needed services and
increase the chances of successful, healthy development.
Finally, Court Teams provide services and supports for families to
preserve and stabilize homes for children. Judges are able to use court
oversight to ensure compliance, facilitate visits with caregivers to
promote positive attachments, and make sure that children are in safe
environments after placement.
The Safe Babies Act will make an important impact in the way we treat
infants and toddlers in the court system. By facilitating involvement
from all parties, Court Teams are better equipped to ensure that young
children have the community support and services they need. Early
evaluation research in the Miami/Dade County court project finds a high
rate of permanency for children in the court and increased quality of
parent-child interaction. By finding permanent homes, children were
able to escape the limbo of the foster care system. More importantly,
the court was successful in preventing any future recurrence of abuse
or neglect.
Together we can work to protect the safety and well-being of our
infants and toddlers. With this legislation, we have the opportunity to
ensure that children are placed quickly in safe and loving homes. I
look forward to working with my colleagues to ensure that this
legislation is passed and signed into law.
Mr. SMITH. Mr. President, I rise today with my colleague from Iowa,
Senator Harkin, to introduce the Safe Babies Act of 2007. The safety
and well-being of our nation's children, including its most vulnerable
infants and toddlers, is very important and I am confident that this
bill will take an important step forward in protecting them.
Mr. President, in our Nation millions of children are reported abused
or neglected each year. Of these, more than 900,000 are confirmed
maltreated by child protective service organizations and our court
systems. Abuse and neglect of children causes about 1,500 deaths each
year. Children who are under the age of four are at the greatest risk
for injury or death--making up nearly 80 percent of child maltreatment
fatalities. We also know that shaken-baby syndrome, SBS, is a form of
abuse that affects more than 1,200 babies each year.
Studies also tell us that younger children who are abused or
neglected are vulnerable to long-term challenges associated with their
maltreatment. Their long-term outcomes show much higher rates for
social, emotional and cognitive impairment. They also are more likely
to adopt high risk behaviors and develop substance abuse and mental
health problems than their peers who have not been abused.
These numbers tell us very loudly that there is a problem in America.
Our most vulnerable and innocent are being abused and need our help.
Children who come through our Nation's court systems need more
support. While the hardworking judges, attorneys, child welfare workers
and volunteers do so much to help stop the child abuse and neglect they
see every day, they too often see families returning to the courts
generation after generation. They see their workloads expand. They see
too many families in strife.
The Safe Babies Act will help these most vulnerable children. This
bill puts into motion a proven model for helping infants and toddlers
to recover from their abuse, and for families to stop the cycle of
abuse and reunite. This model is made up of a judicial and mental
health partnership, or ``court team,'' that provides the needed abuse
and neglect prevention and early intervention services to children and
their families. It is based on a model developed by the Honorable Cindy
Lederman of the Miami-Dade Juvenile Court in Miami. Seeing the success
she has had with this model. It has been replicated in courts across
the nation.
In my home State of Oregon, our Salem courts have developed the
``Foster Attachment'' program based on Judge Lederman's model. This
program brings together the courts, local treatment providers, and
child welfare agencies to provide substance abuse treatment and mental
health treatment, as well as parenting intervention to help parents who
have had their children removed due to methamphetamine use.
I look forward to the passage of this important legislation and to
working with my colleague Senator Harkin to ensure its passage. There
is no issue of greater importance than the safety and welfare of our
next generation. I urge my colleagues on both sides of the aisle to
support this important bill.
______

By Mr. COLEMAN (for himself and Mr. Bayh):
S. 628: A bill to provide grants for rural health information
technology development activities; to the Committee on Health,
Education, Labor, and Pensions.
Mr. COLEMAN. Mr. President, I ask unanimous consent that the text of
the bill I introduced today, the Critical Access to Health Information
Technology Act of 2007, 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. 628

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 ``Critical Access to Health
Information Technology Act of 2007''.

SEC. 2. HEALTH INFORMATION TECHNOLOGY GRANT PROGRAM.

(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall
establish and implement a program to award grants to increase
access to health care in rural areas by improving health
information technology, including the reporting, monitoring,
and evaluation required under this section.
(b) State Grants.--The Secretary shall award grants to
States to be used to carry out the State plan under
subsection (e) through the awarding of subgrants to local
entities within the State. Amounts awarded under such a grant
may only be used in the fiscal year in which the grant is
awarded or in the immediately subsequent fiscal year.
(c) Amount of Grant.--From amounts appropriated under
subsection (k) for each fiscal year, the Secretary shall
award a grant to each State that complies with subsection (e)
in an amount that is based on the total number of critical
access hospitals in the State (as certified by the Secretary
under section 1817(e) of the Social Security Act) bears to
the total number of critical access hospitals in all States
that comply with subsection (e).
(d) Lead Agency.--A State that receives a grant under this
section shall designate a lead agency to--
(1) administer, directly or through other governmental or
nongovernmental agencies, the financial assistance received
under the grant;
(2) develop, in consultation with appropriate
representatives of units of general purpose local government
and the hospital association of the State, the State plan;
and
(3) coordinate the expenditure of funds and provision of
services under the grant with other Federal and State health
care programs.
(e) State Plan.--To be eligible for a grant under this
section, a State shall establish a State plan that shall--
(1) identify the State's lead agency;
(2) provide that the State shall use the amounts provided
to the State under the grant program to address health
information technology improvements and to pay administrative
costs incurred in connection with providing the assistance to
local grant recipients;
(3) provide that benefits shall be available throughout the
entire State; and
(4) require that the lead agency consult with the hospital
association of such State and rural hospitals located in such
State on the most appropriate ways to use the funds received
under the grant.

[[Page S2078]]

(f) Awarding of Local Grants.--
(1) In general.--The lead agency of a State shall use
amounts received under a grant under subsection (a) to award
local grants on a competitive basis. In determining whether a
local entity is eligible to receive a grant under this
subsection, the lead agency shall utilize the following
selection criteria:
(A) The extent to which the entity demonstrates a need to
improve its health information reporting and health
information technology.
(B) The extent to which the entity will serve a community
with a significant low-income or other medically underserved
population.
(2) Application and approval.--To be eligible to receive a
local grant under this subsection, an entity shall be a
government-owned or private nonprofit hospital (including a
non-Federal short-term general acute care facility that is a
critical access hospital located outside a Metropolitan
Statistical Area, in a rural census tract of a Metropolitan
Statistical Area as determined under the most recent version
of the Goldsmith Modification or the Rural-Urban Commuting
Area codes, as determined by the Office of Rural Health
Policy of the Health Resources and Services Administration,
or is located in an area designated by any law or regulation
of the State in which the hospital is located as a rural area
(or is designated by such State as a rural hospital or
organization)) that submits an application to the lead agency
of the State that--
(A) includes a description of how the hospital intends to
use the funds provided under the grant;
(B) includes such information as the State lead agency may
require to apply the selection criteria described in
paragraph (1);
(C) includes measurable objectives for the use of the funds
provided under the grant;
(D) includes a description of the manner in which the
applicant will evaluate the effectiveness of the activities
carried out under the grant;
(E) contains an agreement to maintain such records, make
such reports, and cooperate with such reviews or audits as
the lead agency and the Secretary may find necessary for
purposes of oversight of program activities and expenditures;
(F) contains a plan for sustaining the activities after
Federal support for the activities has ended; and
(G) contains such other information and assurances as the
Secretary may require.
(3) Use of amounts.--
(A) In general.--An entity shall use amounts received under
a local grant under this section to--
(i) offset the costs incurred by the entity after December
31, 2007, that are related to clinical health care
information systems and health information technology
designed to improve quality of health care and patient
safety; and
(ii) offset costs incurred by the entity after December 31,
2007, that are related to enabling health information
technology to be used for the collection and use of
clinically specific data, promoting the interoperability of
health care information across health care settings,
including reporting to Federal and State agencies, and
facilitating clinic decision support through the use of
health information technology.
(B) Eligible costs.--Costs that are eligible to be offset
under subparagraph (A) shall include the cost of--
(i) purchasing, leasing, and installing computer software
and hardware, including handheld computer technologies, and
related services;
(ii) making improvements to existing computer software and
hardware;
(iii) purchasing or leasing communications capabilities
necessary for clinical data access, storage, and exchange;
(iv) services associated with acquiring, implementing,
operating, or optimizing the use of new or existing computer
software and hardware and clinical health care information
systems;
(v) providing education and training to staff on
information systems and technology designed to improve
patient safety and quality of care; and
(vi) purchasing, leasing, subscribing, integrating, or
servicing clinical decision support tools that integrate
patient-specific clinic data with well-established national
treatment guidelines, and provide ongoing continuous quality
improvement functions that allow providers to assess
improvement rates over time and against averages for similar
providers.
(4) Grant limit.--The amount of a local grant under this
subsection shall not exceed $250,000.
(g) Reporting, Monitoring, and Evaluation.--The lead agency
of a State that receives a grant under this section shall
annually report to the Secretary--
(1) the amounts received under the grant;
(2) the amounts allocated to State grant recipients under
the grant;
(3) the breakdown of types of expenditures made by the
local grant recipients with such funds; and
(4) such other information required by the Secretary to
assist the Secretary in monitoring the effectiveness of
activities carried out under this grant.
(h) Review of Compliance With State Plan.--The Secretary
shall review and monitor State compliance with the
requirements of this section and the State plan submitted
under subsection (e). If the Secretary, after reasonable
notice to a State and opportunity for a hearing, finds that
there has been a failure by the State to comply substantially
with any provision or requirement set forth in the State plan
or the requirements of this section, the Secretary shall
notify the lead agency involved of such finding and that no
further payments to the State will be made with respect to
the grant until the Secretary is satisfied that the State is
in compliance or that the noncompliance will be promptly
corrected.
(i) Preemption of Certain Laws.--The provisions of this
section shall preempt applicable Federal and State
procurement laws with respect to health information
technology purchased under this section.
(j) Relation to Other Programs.--Amounts appropriated under
this section shall be in addition to appropriations for
Federal programs for Rural Hospital FLEX grants, Rural Health
Outreach grants, and Small Rural Hospital Improvement Program
grants.
(k) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $10,000,000 for
each of fiscal years 2008 through 2010.

SEC. 3. REPLACEMENT OF THE INTERNATIONAL STATISTICAL
CLASSIFICATION OF DISEASES.

(a) In General.--Not later than October 1, 2008, the
Secretary of Health and Human Services shall promulgate a
final rule concerning the replacement of the International
Statistical Classification of Diseases, 9th revision,
Clinical Modification (referred to in this section as the
``ICD-9-CM''), under the regulation promulgated under section
1173(c) of the Social Security Act (42 U.S.C. 1320d-2(c)),
including for purposes of part A of title XVIII, or part B
where appropriate, of such Act, with the use of each of the
following:
(1) The International Statistical Classification of
Diseases and Related Health Problems, 10th revision, Clinical
Modification (referred to in this section as ``ICD-10-CM''.
(2) The International Statistical Classification of
Diseases and Related Health Problems, 10th revision, Clinical
Modification Coding System (referred to in this section as
``ICD-10-PCS'').
(b) Implementation.--
(1) In general.--The Secretary of Health and Human Services
shall ensure that the rule promulgated under subsection (a)
is implemented by not later than October 1, 2011. In carrying
out the preceding sentence, the Secretary shall ensure that
such rule ensure that Accredited Standards Committee X12
HIPAA transactions version (v) 4010 is upgraded to a newer
version 5010, and that the National Council for Prescription
Drug Programs Telecommunications Standards version 5.1 is
updated to a newer version (to be released by the named by
the National Council for Prescription Drug Programs
Telecommunications Standards) that supersedes, in part,
existing legislation and regulations under the Health
Insurance Portability and Accountability Act of 1996.
(2) Authority.--The Secretary of Health and Human Services
shall have the authority to adopt, without notice and comment
rulemaking, standards for electronic health care transactions
under section 1173 of the Social Security Act (42 U.S.C.
1320d-2) that are recommended to the Secretary by the
Accredited Standards Committee X12 of the American National
Standards Institute in relation to the replacement of ICD-9-
CM with ICD-10-CM and ICD-10-PCS. Such modifications shall be
published in the Federal Register.
(c) Notice of Intent.--Not later than 30 days after the
date of enactment of this Act, the Secretary of Health and
Human Services shall issue and publish in the Federal
Register a Notice of Intent that--
(1) adoption of Accredited Standards Committee X12 HIPAA
transactions version (v) 5010 shall occur not later than
April 1, 2009, and compliance with such rule shall apply to
transactions occurring on or after April 1, 2011;
(2) adoption of the National Council for Prescription Drug
Programs Telecommunications Standards version 5.1 with a new
version will occur not later than April 1, 2009, and
compliance with such rule shall apply to transactions
occurring on or after April 1, 2011;
(3) adoption of ICD-10-CM and ICD-10-PCS will occur not
later than October 1, 2008, and compliance with such rules
shall apply to transactions occurring on or after October 1,
2011; and
(4) covered entities and health technology vendors under
the Health Insurance Potability and Accountability Act of
1996 shall begin the process of planning for and implementing
the updating of the new versions and editions referred to in
this subsection.
(d) Assurances of Code Availability.--The Secretary of
Health and Human Services shall take such action as may be
necessary to ensure that procedure codes are promptly
available for assignment and use under ICD-9-CM until such
time as ICD-9-CM is replaced as a code set standard under
section 1173(c) of the Social Security Act with ICD-10-PCS.
(e) Deadline.--Notwithstanding section 1172(f) of the
Social Security Act (42 U.S.C. 1320d-1(f)), the Secretary of
Health and Human Services shall adopt the modifications
provided for in this section without a recommendation of the
National Committee on Vital and Health Statistics unless such
recommendation is made to the Secretary on or before a date
specified by the Secretary as consistent with the
implementation of the replacement of ICD-9-CM with ICD-10-CM
and ICD-10-PCS for transactions occurring on or after October
1, 2011.

[[Page S2079]]

(f) Limitation on Judicial Review.--The rule promulgated
under subsection (a) shall not be subject to judicial review.
(g) Application.--The rule promulgated under subsection (a)
shall apply to transactions occurring on or after October 1,
2011.
(h) Rule of Construction.--Nothing in this section shall be
construed as effecting the application of classification
methodologies or codes, such as the Current Procedural
Terminology (CPT) as maintained and distributed by the
American Medical Association and the Healthcare Common
Procedure Coding System (HCPCS) as maintained and distributed
by the Department of Health and Human Services, other than
under the International Statistical Classification of Disease
and Related Health Problems.
______

By Mr. COLEMAN:
S. 629. A bill to amend the Consolidated Farm and Rural Development
Act to provide direct and guaranteed loans, loan guarantees, and grants
to complete the construction and rehabilitation of rural critical
access hospitals; to the Committee on Agriculture, Nutrition, and
Forestry.
Mr. COLEMAN. Mr. President, I ask unanimous consent that the text of
the bill I introduce today, to amend the Consolidated Farm and Rural
Development Act to provide direct and guaranteed loans, loan
guarantees, and grants to complete the construction and rehabilitation
of critical access hospitals, 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. 629

Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,

SECTION 1. LOANS, LOAN GUARANTEES, AND GRANTS FOR RURAL
CRITICAL ACCESS HOSPITAL RECONSTRUCTION AND
REHABILITATION.

(a) In General.--Section 306(a) of the Consolidated Farm
and Rural Development Act (7 U.S.C. 1926(a)) is amended--
(1) in paragraph (1)--
(A) by designating the first through fifth sentences as
subparagraphs (A) through (E), respectively; and
(B) by adding at the end the following:
``(F) Loans and loan guarantees for rural critical access
hospital reconstruction and rehabilitation.--Notwithstanding
any other provision of law, the Secretary shall use such sums
as are necessary of the funds of the Commodity Credit
Corporation for the cost of making community facility direct
and guaranteed loans under this paragraph, in a total amount
of not to exceed an additional $1,600,000,000 for the period
of fiscal years 2008 through 2012, to complete the
construction and rehabilitation of critical access hospitals
(as defined in section 1861(mm) of the Social Security Act
(42 U.S.C. 1395x(mm))).''; and
(2) in paragraph (19), by adding at the end the following:
``(D) Grants for rural critical access hospital
reconstruction and rehabilitation.--Notwithstanding any other
provision of law, of the funds of the Commodity Credit
Corporation, the Secretary shall make available an additional
$5,000,000 for the period of fiscal years 2008 through 2012
to make essential community facility grants under this
paragraph to complete the construction and rehabilitation of
critical access hospitals (as defined in section 1861(mm) of
the Social Security Act (42 U.S.C. 1395x(mm))).''.
(b) Conforming Amendments.--Section 306 of the Consolidated
Farm and Rural Development Act (7 U.S.C. 1926) (as amended by
subsection (a)(1)) is amended--
(1) by striking ``Sec. 306. (a)(1)(A) The Secretary is also
authorized to'' and inserting the following:

``SEC. 306. WATER, WASTE DISPOSAL, AND COMMUNITY FACILITY
LOANS, LOAN GUARANTEES, AND GRANTS.

``(a) Authority.--
``(1) Water, waste disposal, and community facilities.--
``(A) In general.--The Secretary may'';
(2) by striking ``(B) The Secretary may also'' and
inserting the following:
``(B) Rural empowerment zones and rural enterprise
communities.--The Secretary may'';
(3) by striking ``(C) The Secretary may also'' and
inserting the following:
``(C) Electric borrowers.--The Secretary may'';
(4) by striking ``(D) When any'' and inserting the
following:
``(D) Gross income.--If any''; and
(5) by striking ``(E) With respect'' and inserting the
following:
``(E) Bond counsel.--With respect''.
______

By Mr. COLEMAN (for himself, Mr. Durbin, and Mr. Harkin):
S. 630. A bill to amend part C of title XVIII of the Social Security
Act to provide for a minimum payment rate by Medicare Advantage
organizations for services furnished by a critical access hospital and
a rural health clinic under the Medicare program; to the Committee on
Finance.
Mr. COLEMAN. Mr. President, I ask unanimous consent that the text of
the bill I introduce today, the Rural Health Services Preservation Act
of 2007, be printed in the Record.
There being no objection, the bill the of the was ordered to be
printed in the Record, as follows:

S. 630

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 ``Rural Health Services
Preservation Act of 2007''.

SEC. 2. MINIMUM PAYMENT RATE BY MEDICARE ADVANTAGE
ORGANIZATIONS FOR SERVICES FURNISHED BY A
CRITICAL ACCESS HOSPITAL AND A RURAL HEALTH
CLINIC.

(a) In General.--Section 1857(e) of the Social Security Act
(42 U.S.C. 1395w-27(e)) is amended by adding at the end the
following:
``(4) Minimum payment rate for services furnished by a
critical access hospital and a rural health clinic.--A
contract under this section between an MA organization and
the Secretary for the offering of an MA plan shall require
the organization to provide for a payment rate under the plan
for inpatient and outpatient critical access hospital
services and rural health clinic services furnished to
enrollees of the plan and for extended care services
furnished by a critical access hospital under an agreement
entered into under section 1883 to such enrollees (whether or
not the services are furnished pursuant to an agreement
between such organization and a critical access hospital or a
rural health clinic) that is not less than--
``(A) the applicable payment rate established under part A
or part B (which includes the payment of an interim rate and
a subsequent cost reconciliation) with respect to the
critical access hospital for such inpatient, outpatient, and
extended care services or the rural health clinic for such
rural health clinic services; or
``(B) if the critical access hospital or the rural health
clinic determines appropriate, 103 percent of the applicable
interim payment rate established under part A or part B with
respect to the critical access hospital for such inpatient,
outpatient, and extended care services or the rural health
clinic for such rural health clinic services.''.
(b) Effective Date.--The amendments made by this section
shall apply to Medicare Advantage contract years beginning on
or after January 1, 2008.
______

By Mr. COLEMAN
S. 631. A bill to amend title XVIII of the Social Security Act to
provide for coverage of remote patient management services for chronic
health care conditions under the Medicare Program; to the Committee on
Finance.
Mr. COLEMAN. Mr. President, I ask unanimous consent that the text of
the bill I introduce today, the Remote Monitoring Access Act of 2007,
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. 631

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 ``Remote Monitoring Access Act
of 2007''.

SEC. 2. FINDINGS.

Congress finds the following:
(1) Remote patient monitoring can make chronic disease
management more effective and efficient for patients and the
health care system.
(2) By collecting, analyzing, and transmitting clinical
health information to a health care practitioner, remote
monitoring technologies allow patients and physicians to
manage the patient's condition in a consistent and real-time
fashion.
(3) Utilization of these technologies not only improves the
quality of care given to patients, it also reduces the need
for frequent physician office appointments, costly emergency
room visits, and unnecessary hospitalizations.
(4) Monitoring a patient's disease from the home reduces
the need for face-to-face physician interactions, thereby
minimizing unnecessary travel and missed work and providing
particular value to individuals residing in rural or
underserved communities who would otherwise face potentially
significant access barriers to receiving needed care.
(5) Four major areas in which remote management
technologies are emerging in health care are the treatment of
congestive heart failure, diabetes, cardiac arrhythmia, and
sleep apnea (sleep disordered breathing). Prompt transmission
of clinical data on each of these conditions, to the
physician or the patient as appropriate, are essential to
providing timely and appropriate therapeutic interventions
which can then reduce expensive hospitalizations.
(6) Despite these innovations, remote management
technologies have failed to diffuse rapidly. A significant
barrier to wider adoption is the relative lack of payment
mechanisms in fee-for-service Medicare to reimburse for
remote, non-face-to-face management.
(7) This Act will eliminate this barrier to new
technologies by requiring Medicare to

[[Page S2080]]

reimburse doctors for time spent analyzing data transmitted
to them by remote patient management technologies.
(8) This Act also promotes high quality care by requiring
the Secretary of Health and Human Services to consult with
physician groups to create a standard of care and a quality
standard for remote patient management services for the
covered chronic conditions.
(9) This Act provides physicians with a financial incentive
to meet or exceed the standard of care and quality standards.

SEC. 3. COVERAGE OF REMOTE PATIENT MANAGEMENT SERVICES FOR
CHRONIC HEALTH CARE CONDITIONS.

(a) In General.--Section 1861(s)(2) of the Social Security
Act (42 U.S.C. 1395x(s)(2)) is amended--
(1) in subparagraph (Z), by striking ``and'' at the end;
(2) in subparagraph (AA), by inserting ``and'' at the end;
and
(3) by inserting after subparagraph (AA) the following new
subparagraph:
``(BB) remote patient management services (as defined in
subsection (ccc));''.
(b) Services Described.--Section 1861 of the Social
Security Act (42 U.S.C. 1395x) is amended by adding at the
end the following new subsection:

``Remote Patient Management Services

``(ccc)(1) The term `remote patient management services'
means the remote monitoring and management of an individual
with a covered chronic health condition (as defined in
paragraph (2)) through the utilization of a system of
technology that allows a remote interface to collect and
transmit clinical data between the individual and the
responsible physician or supplier for the purposes of
clinical review or response by the physician or supplier.
``(2) For purposes of paragraph (1), the term `covered
chronic health condition' includes--
``(A) heart failure;
``(B) diabetes;
``(C) cardiac arrhythmia;
``(D) sleep apnea; and
``(E) any other chronic condition determined by the
Secretary to be appropriate for treatment through remote
patient management services.
``(3)(A) The Secretary, in consultation with appropriate
physician groups, shall develop guidelines on the frequency
of billing for remote patient management services. Such
guidelines shall be determined based on medical necessity and
shall be sufficient to ensure appropriate and timely
monitoring of individuals being furnished such services.
``(B) The Secretary, acting through the Agency for Health
Care Research and Quality, shall do the following:
``(i) Not later than 1 year after the date of enactment of
the Remote Monitoring Access Act of 2007, develop, in
consultation with appropriate physician groups, a standard of
care and quality standards for remote patient management
services for the covered chronic health conditions specified
in subparagraphs (A), (B), (C), and (D) of paragraph (2).
``(ii) If the Secretary makes a determination under
paragraph (2)(E) with respect to a chronic condition,
develop, in consultation with appropriate physician groups, a
standard of care and quality standards for remote patient
management services for such condition within 1 year of such
determination.
``(iii) Periodically review and update such standards of
care and quality standards under this subparagraph as
necessary.''.
(c) Payment Under the Physician Fee Schedule.--Section 1848
of the Social Security Act (42 U.S.C. 1395w-4) is amended--
(1) in subsection (c)--
(A) in paragraph (2)(B)--
(i) in clause (ii)(II), by striking ``and (v)'' and
inserting ``, (v), and (vi)''; and
(ii) by adding at the end the following new clause:
``(vi) Budgetary treatment of certain services.--The
additional expenditures attributable to services described in
section 1861(s)(2)(BB) shall not be taken into account in
applying clause (ii)(II) for 2008.''; and
(B) by adding at the end the following new paragraph:
``(7) Treatment of remote patient management services.--In
determining relative value units for remote patient
management services (as defined in section 1861(ccc)), the
Secretary, in consultation with appropriate physician groups,
shall take into consideration--
``(A) costs associated with such services, including
physician time involved, installation and information
transmittal costs, costs of remote patient management
technology (including devices and software), and resource
costs necessary for patient monitoring and follow-up (but not
including costs of any related item or non-physician service
otherwise reimbursed under this title); and
``(B) the level of intensity of services provided, based
on--
``(i) the frequency of evaluation necessary to manage the
individual being furnished the services;
``(ii) the amount of time necessary for, and the complexity
of the evaluation, including the information that must be
obtained, reviewed, and analyzed; and
``(iii) the number of possible diagnoses and the number of
management options that must be considered.''; and
(2) in subsection (j)(3), by inserting ``(2)(BB),'' after
``(2)(AA),''.
(d) Incentive Payments.--Section 1833 of the Social
Security Act (42 U.S.C. 1395l) is amended by adding at the
end the following new subsection:
``(v) Incentive for Meeting Certain Standards of Care and
Quality Standards in the Furnishing of Remote Patient
Management Services.--In the case of remote patient
management services (as defined in section 1861(ccc)) that
are furnished by a physician who the Secretary determines
meets or exceeds the standards of care and quality standards
developed by the Secretary under paragraph (3)(B) of such
section for such services, in addition to the amount of
payment that would otherwise be made for such services under
this part, there shall also be paid to the physician (or to
an employer or facility in cases described in subclause (A)
of section 1842(b)(6)) (on a monthly or quarterly basis) from
the Federal Supplementary Medical Insurance Trust Fund an
amount equal to 10 percent of the payment amount for the
service under this part.''.
(e) Effective Date.--The amendments made by this section
shall apply to services furnished on or after January 1,
2008.
______

By Mr. COLEMAN (for himself and Ms. Klobuchar):
S. 632. A bill to provide for a hospital in Cass County, Minnesota;
to the Committee on Finance.
Mr. COLEMAN. Mr. President, I ask unanimous consent that the text of
the bill I introduce today, to provide for a hospital in Cass County,
Minnesota, 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. 632

Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,

SECTION 1. MEDICARE CRITICAL ACCESS HOSPITAL DESIGNATION.

Section 405(h) of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (Public Law 108-
173; 117 Stat. 2269) is amended by adding at the end the
following new paragraph:
``(3) Exception.--
``(A) In general.--The amendment made by paragraph (1)
shall not apply to the certification by the State of
Minnesota on or after January 1, 2006, under section
1820(c)(2)(B)(i)(II) of the Social Security Act (42 U.S.C.
1395i-4(c)(2)(B)(i)(II)) of one hospital that meets the
criteria described in subparagraph (B) and is located in Cass
County, Minnesota, as a necessary provider of health care
services to residents in the area of the hospital.
``(B) Criteria described.--A hospital meets the criteria
described in this subparagraph if the hospital--
``(i) has been granted an exception by the State to an
otherwise applicable statutory restriction on hospital
construction or licensing prior to the date of enactment of
this subparagraph; and
``(ii) is located on property which the State has approved
for conveyance to a county within the State prior to such
date of enactment.''.
______

By Mr. COLEMAN:
S. 633. A bill to provide assistance to rural schools, hospitals, and
communities for the conduct of collaborative efforts to secure a
progressive and innovative system to improve access to mental health
care for youth, seniors and families; to the Committee on Health,
Education, Labor, and Pensions.
Mr. COLEMAN. Mr. President, I ask unanimous consent that the text of
the bill I introduce today, the Working Together for Rural Access to
Mental Health and Wellness for Children and Seniors Act, 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. 633

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 ``Working Together for Rural
Access to Mental Health and Wellness for Children and Seniors
Act''.

SEC. 2. FINDINGS AND PURPOSE.

(a) Findings.--Congress makes the following findings:
(1) Providing adequate mental health care in rural
communities is a national problem. Mental health is an
integral part of a person's general health and well-being. In
rural areas, where specialized mental health services are
scarce, accessing mental health professional services is
difficult. Primary care is often the only system for
delivering mental health services.
(2) Rural primary care providers are seeing an increase in
mental health issues in their clinics.
(3) The need is overwhelming with the Surgeon General
estimating 21 percent of children experience the signs or
symptoms of a mental disorder. Left untreated, these problems
lead to rampant school failure, drug abuse, and often
incarceration.

[[Page S2081]]

(4) The Department of Health and Human Services indicates
that 1 in 5 children and adolescents may have a diagnosable
disorder, yet 70 percent to 80 percent receive little or no
help.
(5) Few schools have the resources to implement a full
range of school mental health interventions. Identifying
sustainable and flexible funding sources for these programs
is extremely important.
(6) Health, and especially mental health, is a fundamental
cornerstone for ensuring that all youth have an equal
opportunity to succeed at school.
(7) Promoting and expanding telemental health
collaborations to strengthen delivery of mental health
services in remote and underserved areas is needed.
(8) Telemental health is an effective tool for diagnosing
and treating some mental health conditions. For rural and
remote areas, telemental health offers patients access and
care.
(b) Purpose.--It is the purpose of this Act to--
(1) provide assistance to rural schools, hospitals, and
communities for the conduct of collaborative efforts to
secure a progressive and innovative system to improve access
to mental health care for youth, seniors and families;
(2) increase access of elementary and secondary school
students to mental health services in rural areas by
operating a mobile health services van program in such areas;
or
(3) increase access of individuals of all ages to mental
health services in rural areas by providing telemental health
services in such areas.

SEC. 3. RURAL ACCESS TO MENTAL HEALTH SERVICES GRANT PROGRAM.

(a) State Grants.--The Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall award grants to States to enable such States to award
subgrants to carry out the purposes of this Act.
(b) Eligibility and Amount.--
(1) Eligibility.--To be eligible for a grant under
subsection (a), a State shall submit to the Secretary an
application at such time, in such manner, and containing such
information as the Secretary may require, including an
assurance that the State will designate a lead agency in
accordance with subsection (c) and submit a State plan in
accordance with subsection (d).
(2) Amount.--The Secretary shall award a grant to a State
under this section in an amount that is based on the
respective number of critical access hospitals (as defined in
section 1861 (mm)(1) of the Social Security Act (42 U.S.C.
1395x(mm)(1)) in the State as such compares to the total
number of critical access hospitals in all States that are
awarded grants under this section.
(c) State Lead Agency.--
(1) In general.--To be eligible to receive a grant under
this section, the governor of a State shall select a lead
agency within the State to administer the State programs
under the grant. If the governor of the State selects a lead
agency other than the State Office of Rural Health, the
governor shall ensure the involvement of the State Office of
Rural Health in the development and administration of the
State program under this section.
(2) Duties.--The lead agency of a State shall--
(A) administer, directly or through other governmental or
nongovernmental agencies, amounts received under a grant
under subsection (a); and
(B) develop the State plan under subsection (d) and
coordinate the expenditure of funds in consultation with
appropriate representatives of the State and local
educational agencies and the rural mental health providers
and State hospital associations.
(d) State Plan.--To be eligible to receive a grant under
subsection (a), a State shall submit to the Secretary a State
plan that shall--
(1) identify the lead agency of the State;
(2) contain assurances that the State shall use the amounts
provided to the State under the grant to address--
(A) in the case of mobile van services, the mental health
needs of elementary school and secondary school students; or
(B) in the case of telemental health services, the mental
health needs of individuals of all ages through telemental
health services, and to pay administrative costs incurred in
connection with providing the assistance to grant recipients;
(3) contain assurances that benefits and services under the
grant shall be available throughout the entire State; and
(4) contain assurances that the lead agency shall consult
with rural mental health providers and hospital associations
that represent such providers in such State on the most
appropriate ways to use the funds received under the grant.
(e) Awarding of Subgrants.--
(1) In general.--The lead agency of the State shall use
amounts received under a grant under subsection (a) to award
subgrants to eligible entities on a competitive basis.
(2) Eligibility.--To be eligible to receive a subgrant
under paragraph (1), a grant applicant shall be located in or
serving a rural area and be a government-owned or private
nonprofit hospital (or, in the case of a mobile van services
program, a governmental, tribal, or private nonprofit school
district or educational institution which provides elementary
education or secondary education (kindergarten through grade
12) and that collaborates with such a hospital), a community
mental health center, a primary care clinic, or other
nonprofit agency providing mental health services.
(3) Selection criteria.--In establishing procedures for the
awarding of subgrants under paragraph (1), the lead agency of
the State shall provide for the use of the following
selection criteria:
(A) The extent to which a grant applicant demonstrates a
need to improve the access of mental health services within
the community served by such applicant.
(B) The extent to which a grant applicant will serve a
rural community with a significant low-income or other
population that is underserved with respect to the provision
of mental health services.
(4) Application and approval.--To be eligible to receive a
subgrant under paragraph (1), an entity shall submit an
application to the lead agency of the State that includes--
(A) a description of the manner in which the entity intends
to use amounts provided under the subgrant;
(B) such information as the lead agency may require to
apply the selection criteria under paragraph (3);
(C) measurable objectives for the use of funds provided
under the subgrant;
(D) a description of the manner in which the applicant will
evaluate the effectiveness of the program carried out under
the subgrant;
(E) an agreement to maintain such records, make such
reports, and cooperate with such reviews or audits as the
lead agency and the Secretary may find necessary for purposes
of oversight of program activities and expenditures;
(F) a plan for sustaining activities and services funded
under the subgrant after Federal support for such activities
and services has ended; and
(G) such other information and assurances as the Secretary
may require.
(5) Use of funds.--A recipient of a subgrant under
paragraph (1) shall use amounts awarded under the grant to--
(A) in the case of mobile van health services, offset costs
incurred after December 31, 2007, that are related to
operating a mobile van outreach program under which a
hospital and one or more elementary or secondary schools
provide mental health care services to students of such
schools in the rural area, which may include the costs of--
(i) purchasing or leasing a mobile van in which mental
health services are provided to elementary school or
secondary school students;
(ii) repairs and maintenance for such a mobile van;
(iii) purchasing or leasing communications capabilities
reasonable and necessary to operate the mobile van;
(iv) providing education and training to staff on operating
the mobile van program; and
(v) providing for additional mental health services
professional staff that are employed to provide mental health
services as part of the mobile van program; and
(B) in the case of telemental health services, offset costs
incurred after December 31, 2007, that are related to
providing telemental health services to persons of all ages
in the rural area, which may include the cost of--
(i) purchasing, leasing, repairing, maintaining, or
upgrading telemental health services equipment;
(ii) operating telemental health services equipment,
including telecommunications, utilities, and software costs;
(iii) providing education and training to staff concerning
the provision of telemental health services; and
(iv) employing additional mental health services
professional staff to provide telemental health services.
(6) Limits.--The amount awarded to an entity as a subgrant
under paragraph (1) for any fiscal year shall not exceed
$300,000.
(f) Reporting, Monitoring, and Evaluation.--The lead agency
of each State that receives a grant under subsection (a)
shall submit a report to the Secretary that contains--
(1) the amounts received under the grant;
(2) the amounts allocated as subgrants under subsection
(e);
(3) the types of expenditures made by subgrant recipients
with such funds; and
(4) such other information as may be required by the
Secretary to assist the Secretary in monitoring the
effectiveness of this section.
(g) Review of Compliance With State Plan.--
(1) In general.--The Secretary shall review and monitor
State compliance with the requirements of this section and
the State plan submitted under subsection (d).
(2) Failure to comply.--If the Secretary, after reasonable
notice to a State and opportunity for a hearing, determines
that there has been a failure by the State to comply
substantially with any provision or requirement set forth in
the State plan or a requirement of this section, the
Secretary shall notify the lead agency of the State of such
determination and that no further payments to the State will
be made with respect to the State grant until the Secretary
is satisfied that there is no longer any failure to comply or
that the noncompliance will be promptly corrected.
(h) Interaction of Federal and State Law.--Federal and
State procurement laws shall be preempted to the extent
necessary to carry out this section.

[[Page S2082]]

(i) Definitions.--In this section:
(1) Hospital.--The term ``hospital'' means a non-Federal
short-term general acute care facility located in or serving
a rural area.
(2) Mobile van.--The term ``mobile van'' means a mobile
wellness center the purpose of which is to improve access to,
and focuses on, early intervention of mental health, and that
provides consultation, education, comprehensive
interdisciplinary education, and collaborative treatment
planning services.
(3) Rural area.--The term ``rural area'', with respect to
the location of an eligible applicant, or with respect to the
location of mental health services, means that the entity or
services--
(A) is located in a rural census tract of a metropolitan
statistical area, as determined under the most recent version
of the Goldsmith Modification, the Rural-Urban Commuting Area
codes, as determined by the Office of Rural Health Policy of
the Health Resources and Services Administration; or
(B) is located in an area designated by any law or
regulation of such State as a rural area (or, in the case of
a hospital, is designated by such State as a rural hospital).
(4) Telemental health services.--The term ``telemental
health services'' means mental health services that are
provided through the use of videoconferencing or similar
means of electronic communications and information
technology.
(5) Telemental health services equipment.--The term
``telemental health services equipment'' includes
telecommunications and peripheral equipment used to provide
patient evaluations, case management, medication management,
crisis response, pre-admission and pre-discharge planning,
treatment planning, individual and group therapy, family
therapy, mental status evaluations, case conferences, family
visits, staff training, and administrative activities
relating to the mental health services.
(j) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, $10,000,000 for
each of fiscal years 2008 through 2010.
______

By Mr. DODD (for himself and Mr. Hatch):
S. 634. A bill to amend the Public Health Service Act to establish
grant programs to provide for education and outreach on newborn
screening and coordinated followup care once newborn screening has been
conducted, to reauthorize programs under part A of title XI of such
Act, and for other purposes; to the Committee on Health, Education,
Labor, and Pensions.
Mr. DODD. Mr. President, I am pleased today to join with my colleague
Senator Hatch to introduce legislation to protect the most vulnerable
members of our society: newborn infants. Many people know the joy of
parenthood. These parents know the sense of worry about whether their
kids are doing well, are feeling well, and are safe. Nothing is of
greater importance than the health and well-being of our children.
Thanks to incredible advances in medical technology, it is now
possible to test newborns for more than 50 genetic and metabolic
disorders. Many of these disorders, if undetected, would lead to severe
disability or death. However, babies that are properly diagnosed and
treated can, in many cases, go on to live healthy lives. So newborn
screening can literally save lives.
Frighteningly, the disorders that newborn screening tests for can
come without warning. For most of these disorders, there is no medical
history of the condition in the family and no way to predict the health
of a baby based on the health of the parents. Although the disorders
that are tested for are quite rare, there is a chance that any one
newborn will be affected. In that sense, this is an issue that has a
direct impact on the lives of all families.
Fortunately, some screening has become common practice in every
state. Each year, over four million infants have blood taken from their
heel after birth to detect these disorders that could threaten their
life and long-term health. As a result, about one in 4,000 babies is
diagnosed with one of these disorders. That means that newborn
screening could protect the health or save the life of approximately
1,000 newborns each year. That is 1,000 tragedies that can be averted
families that can know the joy of a new infant rather than absolute
heartbreak.
In 2004, the American College of Medical Genetics (ACMG) completed a
report commissioned by the U.S. Department of Health and Human Services
which recommended that every baby born in the U.S. be screened for
twenty-nine disorders, including certain metabolic conditions and
hearing deficiency. Unfortunately, as of February 2007, only 11 States
and the District of Columbia require infants to be screened for all
twenty-nine of these recommended disorders. If diagnosed early, all of
these conditions can be successfully managed or treated to prevent or
mitigate severe and often lifelong health problems.
For every baby saved, another two are estimated to be born with
potentially detectable disorders that go undetected because they are
not screened. These infants and their families face the prospect of
disability or death from a preventable disorder. The survival of a
newborn may very well come down to the state in which it is born,
because not all states test for every detectable disorder.
The Government Accountability Office, GAO, released a report in 2003
highlighting the need for this legislation. According to the report,
most states do not educate parents and health care providers about the
availability of tests beyond what is mandated by a State. States also
reported that they do not have the resources to purchase the technology
and train the staff needed to expand newborn screening programs.
Finally, even when States do detect an abnormal screening result, the
majority do not inform parents directly.
The legislation that we are introducing today will give states an
additional helping hand toward meeting the advisory's committee's
recommendation by providing $25 million for states to expand and
improve their newborn screening programs. In order to access these
resources, states will be required to commit to screening for all 29
disorders.
Our legislation will also authorize $15 million for two types of
grants. The first seeks to address the lack of information available to
health care professionals and parents about newborn screening. Every
parent should have the knowledge necessary to protect their child. The
tragedy of a newborn's death is only compounded by the frustration of
learning that the death was preventable. This bill authorizes grants to
provide education and training to health care professionals, state
laboratory personnel, families and consumer advocates.
The second type of grant will support States in providing follow-up
care for those children diagnosed by a disorder detected through
newborn screening. While these families are the fortunate ones, in many
cases they are still faced with the prospect of extended and complex
treatment and major lifestyle changes. We need to remember that care
does not stop at diagnosis.
To ensure the quality of laboratories involved in newborn screening,
so that tests are as accurate as possible and infants receive
appropriate care, the legislation authorizes $5 million for the Centers
for Disease Control and Prevention, CDC, to carry out a number of
functions such as quality assurance for newborn screening tests,
performance evaluation services, and technical assistance and
technology transfer to newborn screening labs.
In the event of a public health emergency, such as Hurricane Katrina,
newborn screening may seem like a low priority. However, if babies
aren't tested and, when necessary, treated within the first few days of
life, they may suffer irreparable harm or even death. In the wake of a
public health crisis, contingency planning for newborn screening is
essential. Our legislation requires the CDC, in consultation with the
Health Resources and Services Administration, HRSA, to develop a
national contingency plan for newborn screening in the event of a
public health emergency within 180 days of enactment of the bill.
Finally, the bill directs the CDC, in consultation with HRSA, to
establish a national surveillance program for newborn screening, and
authorizes $15 million for that purpose. Such a program will help us
conduct research to better understand these rare disorders, and will
hopefully lead us toward more effective treatments and cures.
I urge my colleagues to support this important legislation so that
every newborn child will have the best possible opportunity that
America can offer to live a long, healthy and happy life. I look
forward to working with the Chairman of the Health, Education, Labor
and Pensions (HELP) Committee, Senator Kennedy, and Ranking Member Enzi
to advance this legislation as early as possible.

[[Page S2083]]

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. 634

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 ``Newborn Screening Saves
Lives Act of 2007''.

SEC. 2. FINDINGS.

Congress finds the following:
(1) Each year more than 4,000,000 babies born in the United
States are screened by State and private laboratories to
detect some conditions that may threaten their long-term
health.
(2) However, there is a lack of uniformity in the number of
conditions for which newborns are screened throughout the
United States. While a newborn may be screened and treated
for a debilitating condition in one State, in another State,
the condition may go undetected and result in permanent
disability or even death.
(3) Approximately 4,000 infants born each year are
diagnosed with these detectable and treatable disorders. If
diagnosed early, these conditions can be successfully managed
or treated to prevent severe and often lifelong health
consequences.
(4) In 2004, the American College of Medical Genetics
(ACMG) completed a report commissioned by the Department of
Health and Human Services which recommended that every baby
born in the United States be screened for 29 specific
disorders, including certain metabolic conditions and hearing
deficiencies.
(5) Currently only 11 States and the District of Columbia
require infants to be screened for all 29 of these
recommended disorders.
(6) Continuity, especially during a public health
emergency, plays a critical role in the screening, diagnosis,
referral, and treatment of these disorders. Currently there
is no national contingency plan for maintaining continuity of
newborn screening systems following a public health
emergency.

SEC. 3. AMENDMENT TO TITLE III OF THE PUBLIC HEALTH SERVICE
ACT.

Part Q of title III of the Public Health Service Act (42
U.S.C. 280h et seq.) is amended by adding at the end the
following:

``SEC. 399AA. NEWBORN SCREENING.

``(a) Authorization of Grant Programs.--
``(1) Grants to assist health care professionals.--From
funds appropriated under subsection (h), the Secretary,
acting through the Associate Administrator of the Maternal
and Child Health Bureau of the Health Resources and Services
Administration (referred to in this section as the `Associate
Administrator') and in consultation with the Advisory
Committee on Heritable Disorders in Newborns and Children
(referred to in this section as the `Advisory Committee'),
shall award grants to eligible entities to enable such
entities to assist in providing health care professionals and
newborn screening laboratory personnel with--
``(A) education in newborn screening; and
``(B) training in--
``(i) relevant and new technologies in newborn screening;
and
``(ii) congenital, genetic, and metabolic disorders.
``(2) Grants to assist families.--
``(A) In general.--From funds appropriated under subsection
(h), the Secretary, acting through the Associate
Administrator and in consultation with the Advisory
Committee, shall award grants to eligible entities to enable
such entities to develop and deliver educational programs
about newborn screening to parents, families, and patient
advocacy and support groups. The educational materials
accompanying such educational programs shall be provided at
appropriate literacy levels.
``(B) Awareness of the availability of programs.--To the
extent practicable, the Secretary shall make relevant health
care providers aware of the availability of the educational
programs supported pursuant to subparagraph (A).
``(3) Grants for quality newborn screening followup.--From
funds appropriated under subsection (h), the Secretary,
acting through the Associate Administrator and in
consultation with the Advisory Committee, shall award grants
to eligible entities to enable such entities to establish,
maintain, and operate a system to assess and coordinate
treatment relating to congenital, genetic, and metabolic
disorders.
``(b) Application.--An eligible entity that desires to
receive a grant under this section shall submit an
application to the Secretary at such time, in such manner,
and accompanied by such information as the Secretary may
require.
``(c) Selection of Grant Recipients.--
``(1) In general.--Not later than 120 days after receiving
an application under subsection (b), the Secretary, after
considering the approval factors under paragraph (2), shall
determine whether to award the eligible entity a grant under
this section.
``(2) Approval factors.--
``(A) Requirements for approval.--An application submitted
under subsection (b) may not be approved by the Secretary
unless the application contains assurances that the eligible
entity--
``(i) will use grant funds only for the purposes specified
in the approved application and in accordance with the
requirements of this section; and
``(ii) will establish such fiscal control and fund
accounting procedures as may be necessary to assure proper
disbursement and accounting of Federal funds paid to the
eligible entity under the grant.
``(B) Existing programs.--Prior to awarding a grant under
this section, the Secretary shall--
``(i) conduct an assessment of existing educational
resources and training programs and coordinated systems of
followup care with respect to newborn screening; and
``(ii) take all necessary steps to minimize the duplication
of the resources and programs described in clause (i).
``(d) Coordination.--The Secretary shall take all necessary
steps to coordinate programs funded with grants received
under this section.
``(e) Use of Grant Funds.--
``(1) Grants to assist health care professionals.--An
eligible entity that receives a grant under subsection (a)(1)
may use the grant funds to work with appropriate medical
schools, nursing schools, schools of public health, schools
of genetic counseling, internal education programs in State
agencies, nongovernmental organizations, and professional
organizations and societies to develop and deliver education
and training programs that include--
``(A) continuing medical education programs for health care
professionals and newborn screening laboratory personnel in
newborn screening;
``(B) education, technical assistance, and training on new
discoveries in newborn screening and the use of any related
technology;
``(C) models to evaluate the prevalence of, and assess and
communicate the risks of, congenital conditions, including
the prevalence and risk of some of these conditions based on
family history;
``(D) models to communicate effectively with parents and
families about--
``(i) the process and benefits of newborn screening;
``(ii) how to use information gathered from newborn
screening;
``(iii) the meaning of screening results, including the
possibility of false positive findings;
``(iv) the right of refusal of newborn screening, if
applicable; and
``(v) the potential need for followup care after newborns
are screened;
``(E) information and resources on coordinated systems of
followup care after newborns are screened;
``(F) information on the disorders for which States require
and offer newborn screening and options for newborn screening
relating to conditions in addition to such disorders;
``(G) information on additional newborn screening that may
not be required by the State, but that may be available from
other sources; and
``(H) other items to carry out the purpose described in
subsection (a)(1) as determined appropriate by the Secretary.
``(2) Grants to assist families.--An eligible entity that
receives a grant under subsection (a)(2) may use the grant
funds to develop and deliver to parents, families, and
patient advocacy and support groups, educational programs
about newborn screening that include information on--
``(A) what newborn screening is;
``(B) how newborn screening is performed;
``(C) who performs newborn screening;
``(D) where newborn screening is performed;
``(E) the disorders for which the State requires newborns
to be screened;
``(F) different options for newborn screening for disorders
other than those included by the State in the mandated
newborn screening program;
``(G) the meaning of various screening results, including
the possibility of false positive and false negative
findings;
``(H) the prevalence and risk of newborn disorders,
including the increased risk of disorders that may stem from
family history;
``(I) coordinated systems of followup care after newborns
are screened; and
``(J) other items to carry out the purpose described in
subsection (a)(2) as determined appropriate by the Secretary.
``(3) Grants for quality newborn screening followup.--An
eligible entity that receives a grant under subsection (a)(3)
shall use the grant funds to--
``(A) expand on existing procedures and systems, where
appropriate and available, for the timely reporting of
newborn screening results to individuals, families, primary
care physicians, and subspecialists in congenital, genetic,
and metabolic disorders;
``(B) coordinate ongoing followup treatment with
individuals, families, primary care physicians, and
subspecialists in congenital, genetic, and metabolic
disorders after a newborn receives an indication of the
presence or increased risk of a disorder on a screening test;
``(C) ensure the seamless integration of confirmatory
testing, tertiary care medical services, comprehensive
genetic services including genetic counseling, and
information about access to developing therapies by
participation in approved clinical trials involving the
primary health care of the infant;
``(D) analyze data, if appropriate and available, collected
from newborn screenings to identify populations at risk for
disorders affecting newborns, examine and respond to

[[Page S2084]]

health concerns, recognize and address relevant
environmental, behavioral, socioeconomic, demographic, and
other relevant risk factors; and
``(E) carry out such other activities as the Secretary may
determine necessary.
``(f) Reports to Congress.--
``(1) In general.--Subject to paragraph (2), the Secretary
shall submit to the appropriate committees of Congress
reports--
``(A) evaluating the effectiveness and the impact of the
grants awarded under this section--
``(i) in promoting newborn screening--

``(I) education and resources for families; and
``(II) education, resources, and training for health care
professionals;

``(ii) on the successful diagnosis and treatment of
congenital, genetic, and metabolic disorders; and
``(iii) on the continued development of coordinated systems
of followup care after newborns are screened;
``(B) describing and evaluating the effectiveness of the
activities carried out with grant funds received under this
section; and
``(C) that include recommendations for Federal actions to
support--
``(i) education and training in newborn screening; and
``(ii) followup care after newborns are screened.
``(2) Timing of reports.--The Secretary shall submit--
``(A) an interim report that includes the information
described in paragraph (1), not later than 30 months after
the date on which the first grant funds are awarded under
this section; and
``(B) a subsequent report that includes the information
described in paragraph (1), not later than 60 months after
the date on which the first grant funds are awarded under
this section.
``(g) Definition of Eligible Entity.--In this section, the
term `eligible entity' means--
``(1) a State or a political subdivision of a State;
``(2) a consortium of 2 or more States or political
subdivisions of States;
``(3) a territory;
``(4) an Indian tribe or a hospital or outpatient health
care facility of the Indian Health Service; or
``(5) a nongovernmental organization with appropriate
expertise in newborn screening, as determined by the
Secretary.
``(h) National Contingency Plan for Newborn Screening.--
``(1) In general.--Not later than 180 days after the date
of enactment of this section, the Secretary, acting through
the Director of the Centers for Disease Control and
Prevention and in consultation with the Associate
Administrator, shall develop a national contingency plan for
newborn screening for use in the event of a public health
emergency.
``(2) Requirements.--The contingency plan developed under
paragraph (1) shall include a plan for--
``(A) the collection and transport of specimens;
``(B) the shipment of specimens to State newborn screening
laboratories;
``(C) the processing of specimens;
``(D) the reporting of screening results to physicians and
families;
``(E) the diagnostic confirmation of positive screening
results;
``(F) ensuring the availability of treatment and management
resources;
``(G) educating families about newborn screening; and
``(H) carrying out other activities determined appropriate
by the Secretary.
``(i) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section--
``(1) $15,000,000 for fiscal year 2008; and
``(2) such sums as may be necessary for each of fiscal
years 2009 through 2012.''.

SEC. 4. IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE
DISORDERS.

Section 1109 of the Public Health Service Act (42 U.S.C.
300b-8) is amended--
(1) in subsection (c)(2)--
(A) in subparagraph (E), by striking ``and'' after the
semicolon;
(B) by redesignating subparagraph (F) as subparagraph (G);
and
(C) by inserting after subparagraph (E) the following:
``(F) an assurance that the entity has adopted and
implemented, is in the process of adopting and implementing,
or will use grant amounts received under this section to
adopt and implement the guidelines and recommendations of the
Advisory Committee on Heritable Disorders in Newborns and
Children established under section 1111 (referred to in this
section as the `Advisory Committee') that are adopted by the
Secretary and in effect at the time the grant is awarded or
renewed under this section, which shall include the screening
of each newborn for the heritable disorders recommended by
the Advisory Committee and adopted by the Secretary and the
reporting of results; and''; and
(2) in subsection (i), by striking ``such sums'' and all
that follows through the period at the end and inserting
``$25,000,000 for fiscal year 2008 and such sums as may be
necessary for each of the fiscal years 2009 through 2012.''.

SEC. 5. EVALUATING THE EFFECTIVENESS OF NEWBORN- AND CHILD-
SCREENING PROGRAMS.

Section 1110 of the Public Health Service Act (42 U.S.C.
300b-9) is amended by adding at the end the following:
``(d) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section
$5,000,000 for fiscal year 2008 and such sums as may be
necessary for each of the fiscal years 2009 through 2012.''.

SEC. 6. ADVISORY COMMITTEE ON HERITABLE DISORDERS IN NEWBORNS
AND CHILDREN.

Section 1111 of the Public Health Service Act (42 U.S.C.
300b-10) is amended--
(1) in subsection (b)--
(A) by redesignating paragraph (3) as paragraph (5);
(B) in paragraph (2), by striking ``and'' after the
semicolon;
(C) by inserting after paragraph (2) the following:
``(3) recommend a uniform screening panel for newborn
screening programs that includes the heritable disorders for
which all newborns should be screened, including secondary
conditions that may be identified as a result of the
laboratory methods used for screening;
``(4) develop a model decision-matrix for newborn screening
program expansion, and periodically update the recommended
uniform screening panel described in paragraph (3) based on
such decision-matrix; and''; and
(D) in paragraph (5) (as redesignated by subparagraph (A)),
by striking the period at the end and inserting ``, including
recommendations, advice, or information dealing with--
``(A) followup activities, including those necessary to
achieve rapid diagnosis in the short term, and those that
ascertain long-term case management outcomes and appropriate
access to related services;
``(B) diagnostic and other technology used in screening;
``(C) the availability and reporting of testing for
conditions for which there is no existing treatment;
``(D) minimum standards and related policies and procedures
for State newborn screening programs;
``(E) quality assurance, oversight, and evaluation of State
newborn screening programs;
``(F) data collection for assessment of newborn screening
programs;
``(G) public and provider awareness and education;
``(H) language and terminology used by State newborn
screening programs;
``(I) confirmatory testing and verification of positive
results; and
``(J) harmonization of laboratory definitions for results
that are within the expected range and results that are
outside of the expected range.''; and
(2) by adding at the end the following:
``(d) Decision on Recommendations.--
``(1) In general.--Not later than 180 days after the
Advisory Committee issues a recommendation pursuant to this
section, the Secretary shall adopt or reject such
recommendation.
``(2) Pending recommendations.--The Secretary shall adopt
or reject any recommendation issued by the Advisory Committee
that is pending on the date of enactment of the Newborn
Screening Saves Lives Act of 2007 by not later than 180 days
after the date of enactment of such Act.
``(3) Determinations to be made public.--The Secretary
shall publicize any determination on adopting or rejecting a
recommendation of the Advisory Committee pursuant to this
subsection, including the justification for the
determination.
``(e) Continuation of Operation of Committee.--
Notwithstanding section 14 of the Federal Advisory Committee
Act (5 U.S.C. App.), the Advisory Committee shall continue to
operate during the 5-year period beginning on the date of
enactment of the Newborn Screening Saves Lives Act of
2007.''.

SEC. 7. LABORATORY QUALITY AND SURVEILLANCE.

Part A of title XI of the Public Health Service Act (42
U.S.C. 300b-1 et seq.) is amended by adding at the end the
following:

``SEC. 1112. LABORATORY QUALITY.

``(a) In General.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention
and in consultation with the Advisory Committee on Heritable
Disorders in Newborns and Children established under section
1111, shall provide for--
``(1) quality assurance for laboratories involved in
screening newborns and children for heritable disorders,
including quality assurance for newborn-screening tests,
performance evaluation services, and technical assistance and
technology transfer to newborn screening laboratories to
ensure analytic validity and utility of screening tests; and
``(2) population-based pilot testing for new screening
tools for evaluating use on a mass scale.
``(b) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $5,000,000 for fiscal year 2008 and such sums as
may be necessary for each of the fiscal years 2009 through
2012.

``SEC. 1113. SURVEILLANCE PROGRAMS FOR HERITABLE DISORDERS
SCREENING.

``(a) In General.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention,
in consultation with the Associate Administrator of the
Maternal and Child Health Bureau of the Health Resources and
Services Administration, shall carry out programs--

[[Page S2085]]

``(1) to collect, analyze, and make available data on the
heritable disorders recommended by the Advisory Committee on
Heritable Disorders in Newborns and Children established
under section 1111, including data on the causes of such
disorders and on the incidence and prevalence of such
disorders;
``(2) to operate regional centers for the conduct of
applied epidemiological research on the prevention of such
disorders;
``(3) to provide information and education to the public on
the prevention of such disorders; and
``(4) to conduct research on and to promote the prevention
of such disorders, and secondary health conditions among
individuals with such disorders.
``(b) Grants and Contracts.--
``(1) In general.--In carrying out subsection (a), the
Secretary may make grants to and enter into contracts with
public and nonprofit private entities.
``(2) Supplies and services in lieu of award funds.--
``(A) In general.--Upon the request of a recipient of an
award of a grant or contract under paragraph (1), the
Secretary may, subject to subparagraph (B), provide supplies,
equipment, and services for the purpose of aiding the
recipient in carrying out the purposes for which the award is
made and, for such purposes, may detail to the recipient any
officer or employee of the Department of Health and Human
Services.
``(B) Reduction.--With respect to a request described in
subparagraph (A), the Secretary shall reduce the amount of
payments under the award involved by an amount equal to the
costs of detailing personnel and the fair market value of any
supplies, equipment, or services provided by the Secretary.
The Secretary shall, for the payment of expenses incurred in
complying with such request, expend the amounts withheld.
``(3) Application for award.--The Secretary may make an
award of a grant or contract under paragraph (1) only if an
application for the award is submitted to the Secretary and
the application is in such form, is made in such manner, and
contains such agreements, assurances, and information as the
Secretary determines to be necessary to carry out the
purposes for which the award is to be made.
``(c) Biennial Report.--Not later than February 1 of fiscal
year 2008 and of every second such year thereafter, the
Secretary shall submit to the Committee on Energy and
Commerce of the House of Representatives, and the Committee
on Health, Education, Labor, and Pensions of the Senate, a
report that, with respect to the preceding 2 fiscal years--
``(1) contains information regarding the incidence and
prevalence of heritable disorders and the health status of
individuals with such disorders and the extent to which such
disorders have contributed to the incidence and prevalence of
infant mortality and affected quality of life;
``(2) contains information under paragraph (1) that is
specific to various racial and ethnic groups (including
Hispanics, non-Hispanic whites, Blacks, Native Americans, and
Asian Americans);
``(3) contains an assessment of the extent to which various
approaches of preventing heritable disorders and secondary
health conditions among individuals with such disorders have
been effective;
``(4) describes the activities carried out under this
section;
``(5) contains information on the incidence and prevalence
of individuals living with heritable disorders, information
on the health status of individuals with such disorders,
information on any health disparities experienced by such
individuals, and recommendations for improving the health and
wellness and quality of life of such individuals;
``(6) contains a summary of recommendations from all
heritable disorders research conferences sponsored by the
Centers for Disease Control and Prevention; and
``(7) contains any recommendations of the Secretary
regarding this section.
``(d) Applicability of Privacy Laws.--The provisions of
this section shall be subject to the requirements of section
552a of title 5, United States Code. All Federal laws
relating to the privacy of information shall apply to the
data and information that is collected under this section.
``(e) Coordination.--
``(1) In general.--In carrying out this section, the
Secretary shall coordinate, to the extent practicable,
programs under this section with programs on birth defects
and developmental disabilities authorized under section 317C.
``(2) Priority in grants and contracts.--In making grants
and contracts under this section, the Secretary shall give
priority to entities that demonstrate the ability to
coordinate activities under a grant or contract made under
this section with existing birth defects surveillance
activities.
``(f) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $15,000,000 for fiscal year 2008 and such sums
as may be necessary for each of the fiscal years 2009 through
2012.''.

Mr. HATCH. I am pleased to introduce today, along with my colleague
Senator Christopher Dodd, the Newborn Screening Saves Lives Act of
2007.
Every State and U.S. territory routinely screens newborns for certain
genetic, metabolic, hormonal and functional disorders. Most of these
birth defects have no immediate visible effects on a baby but, unless
detected and treated early, can cause physical problems, mental
retardation and, in some cases, death.
Babies who have these diseases and babies who do not have these
diseases look the same at birth. Fortunately, most babies are given a
clean bill of health when tested. In cases where babies are found to
have metabolic disorders or hearing impairment, early diagnosis and
proper treatment can make the difference between healthy development
and lifelong impairment.
Except for hearing screening, all newborn screening tests are done
using a few drops of blood from the newborn's heel. Newborn screening
checks for diseases that can cause problems with the way the body gets
energy, how the body makes hormones, or how the body makes blood cells.
Currently each state or region operates by law its own newborn
screening program. Individual programs vary widely in the number and
types of conditions for which they test. According to the National
Newborn Screening and Genetics Resources Center, some States test for
as few as four disorders, while others test for 30 or more.
Disparities among States in screening tests given at birth result in
too many babies with serious birth defects not being diagnosed and
treated in time to avoid death or long term disability. Many States
offer only limited educational materials for parents and health care
providers about the availability of newborn screening tests; therefore
parents are often unaware of the importance of testing and may learn
too late that their newborn has an abnormal metabolic condition which
could have been treated.
In 2004, the American College of Medical Genetics completed a report
commissioned by the Department of Health and Human Services which
recommended that every baby born in the United States be screened for
29 disorders, including certain metabolic conditions and hearing
deficiency. Currently, only 11 States and the District of Columbia
require the recommended screening for all 29 disorders.
Last year there was much success in improving newborn screening in my
home State of Utah, which increased testing from 4 to 36 disorders. The
expansion of newborn screening is a major advancement for children's
healthcare in Utah, as the screening should identify an additional 15
to 20 Utah infants every year in time to help them get the treatment
they need to live a fuller and healthier life.
Enactment of the Newborn Screening Saves Lives Act would provide
necessary resource materials to educate parents and health providers
about newborn screening and help states expand and improve their
newborn screening programs. Other important provisions of this
legislation help ensure the quality of laboratories involved in newborn
screening and call for establishing a system for collecting and
analyzing data from newborn screening programs.
The bill will establish grant programs to provide for education and
outreach on newborn screening and coordinated follow-up care once
newborn screening has been conducted. It will help States expand and
improve their newborn screening programs, educate parents and providers
and improve follow-up care for infants. The bill also contains
provisions for a contingency plan for newborn screening in the case of
a national public health emergency, such as that which was witnessed in
the wake of Hurricanes Katrina and Rita.
The Newborn Screening Saves Lives Act of 2007 is endorsed by the
March of Dimes, the American Academy of Pediatrics, Easter Seals, and
the American Public Health Labs. These groups recognize that expanded
newborn screening will help pediatricians and other healthcare
providers identify rare disorders than can be easily confused with
common pediatric problems. Diagnosing and treating these conditions
will help prevent irreversible brain damage, permanent disabilities,
and possibly death. I urge my colleagues to take a stand for newborn
health and support this bill.
______

By Mr. SCHUMER:
S. 636. A bill to amend the Internal Revenue Code of 1986 to extend
the reporting period for certain statements

[[Page S2086]]

sent to taxpayers; to the Committee on Finance.
Mr. SCHUMER. Mr. President, I rise today to introduce the ``Reduce
Wasteful Tax Forms Act of 2007.'' This bill extends the deadline from
January 31 to February 15 for certain types of 1099 forms to be sent to
taxpayers. 1099 forms are used to report non-wage income, such as
income from dividends and capital gains. These forms are distributed by
brokerage firms and financial institutions to their investors, who must
report the information on their income tax returns.
Due to recent changes in tax laws that govern income from interest
and dividends, there has been a significant increase in the number of
inaccurate forms sent out by firms in order to meet the January 31
deadline. The problem is that much of the tax data for certain types of
investment income cannot be calculated until after the first of the
year, resulting in a compressed window for calculating data in
compliance with the new laws and mailing the forms. Once accurate data
becomes available, financial institutions must send taxpayers an
amended form with the correct information.
These amended forms create confusion for taxpayers, and in some
cases, those who receive an amended 1099 may have to re-file their
taxes. If taxpayers underpaid in their initial return, they could face
interest charges and penalties if they do not file again before the
April 15 deadline. The January 31 deadline results in tons of wasted
paper, confusion for taxpayers, and wasted expenses incurred in sending
the amended forms.
This problem affects an increasing number of taxpayers. According to
recent press reports in the Wall Street Journal and USA Today, prior to
2003, an average of 5 to 8 percent of 1099 forms required correcting.
That number has since jumped to an average of 13 percent, translating
into millions of amended 1099s being sent to taxpayers each year.
My legislation would extend the deadline for sending 1099 forms to
taxpayers to February 15, by which time the vast majority of required
data will be available to ensure the accuracy of the forms. The bill
extends the deadline only for certain types of 1099 forms used to
report investment income; it would not extend the deadline for 1099
forms sent to independent contractors or for statements that only
report interest earned on bank deposits. Accordingly, this extension
will not delay filing for the vast majority of taxpayers.
This year, the IRS granted several brokerage firms an extension to
the January 31 deadline. However, this bill would provide a permanent
extension for all firms and financial institutions to remove the
uncertainty for taxpayers that arises due to this unnecessarily early
deadline. My bill will help taxpayers by reducing confusion, the
financial industry by cutting costs and waste, and the environment by
eliminating millions of unnecessary mailings.
I hope that my colleagues will join me in supporting this
legislation, and I look forward to working with other Finance Committee
members to have it considered during the 110th Congress. 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. 636

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 ``Reduce Wasteful Tax Forms
Act of 2007''.

SEC. 2. EXTENSION OF REPORTING PERIOD FOR CERTAIN STATEMENTS
SENT TO TAXPAYERS.

(a) In General.--The following provisions of the Internal
Revenue Code of 1986 are each amended by striking ``January
31'' and inserting ``February 15'':
(1) Subsection (c) of section 6042 (returns regarding
payments of dividends and corporate earnings and profits).
(2) Subsection (d) of section 6043A (returns relating to
taxable mergers and acquisitions).
(3) Subsection (e) of section 6044 (returns regarding
payments of patronage dividends).
(4) Subsection (b) of section 6045 (returns of brokers).
(5) Subsection (b) of section 6050N (returns regarding
payments of royalties).
(b) Statements Regarding Certain Returns Relating to
Securities.--Section 6041(d) of the Internal Revenue Code of
1986 is amended by striking ``January 31'' and inserting
``January 31 (February 15, in the case of statements
regarding returns relating to payments made by financial
institutions to customers in connection with securities
(including securities lending))''.
(c) Statements Relating to Certain Substitute Payments.--
Section 6045(d) of the Internal Revenue Code of 1986 is
amended--
(1) by striking ``at such time and'', and
(2) by inserting after ``other item.'' the following new
sentence: ``The written statement required under the
preceding sentence shall be furnished on or before February
15 of the year following the calendar year during which such
payment was made.''.
(d) Statements Regarding Certain Reports by Employers and
Plan Administrators.--Section 6047(d)(2) of the Internal
Revenue Code of 1986 is amended by inserting ``, except that
any report to any person other than the Secretary shall be
furnished on or before February 15 of the year following the
calendar year for which the report under paragraph (1) was
required to be made'' after ``regulations''.
(e) Certain Statements Relating to Interest Payments.--
Section 6049(c)(2)(A) of the Internal Revenue Code of 1986 is
amended by striking ``January 31'' and inserting ``February
15 (January 31, in the case of any statement regarding a
return relating to payments of interest made by any obligor
described in subparagraph (B) or (C) of subsection (b)(1),
unless such statement is combined in a statement the due date
for which is February 15)''.
(f) Effective Date.--The amendments made by this section
shall apply to returns, reports, and other statements the due
date for which (determined without regard to extensions) is
after December 31, 2007.
______

By Mr. DURBIN (for himself, Mr. Kerry, and Mr. Menendez):
S. 642. A bill to codify Executive Order 12898, relating to
environmental justice, to require the Administrator of the
Environmental Protection Agency to fully implement the recommendations
of the Inspector General of the Agency and the Comptroller General of
the United States, and for other purposes; to the Committee on
Environment and Public Works.
Mr. DURBIN. Mr. President, today I introduce, with Senators Kerry and
Menendez, an environmental justice bill that will help protect the
well-being of minority and low-income communities throughout the United
States.
In 1994, President Clinton issued an Executive Order instructing
Government agencies to develop strategies to identify and address
environmental inequities that might be created through agency programs.
The Executive Order recognized that low-income and minority communities
often end up with more than their fair share of pollution, associated
health risks and environmental degradation.
More advantaged communities--with strong advocates, more resources,
and better access to information--are less likely to have landfills,
petrochemical plants, or waste incinerators built in their
neighborhoods.
Unfortunately, the U.S. Environmental Protection Agency has not
honored the 1994 Executive Order and the goal of environmental justice
has not been met. In a March 2004 report, the EPA Inspector General
concluded that the agency ``has not fully implemented Executive Order
12898 nor consistently integrated environmental justice into its day-
to-day operations. EPA has not identified minority and low-income
[populations] . . . and has neither defined nor developed criteria for
determining [who is] disproportionately impacted. Moreover, in 2001,
the Agency restated its commitment to environmental justice in a manner
that does not emphasize minority and low-income populations, the intent
of the Executive Order.''
Today, with the introduction of the Environmental Justice Act of
2007, we ask Congress to codify the Executive Order. The legislation
also directs the EPA to implement recommendations in this area from
both the EPA Inspector General and the Government Accountability
Office. The recommendations include creating offices to review programs
and policies for environmental justice implications, training staff to
address environmental justice concerns in the rule making process and
specifically assessing the impacts of future regulation and enforcement
on the communities most at risk to human and environmental health
problems. Finally, the bill establishes reporting requirements for the
implementation of the recommendations.
I am pleased that our legislation currently has the support of 18
organizations, including: Earthjustice; Lawyers' Committee for Civil
Rights Under

[[Page S2087]]

Law; Center for Health, Environment and Justice; Natural Resources
Defense Council; Advocates for Environmental Human Rights and Labor
Council for Latin American Advancement.
The bill we are introducing today is an important step toward
shifting the balance of environmental hazards, so the burden is not
shouldered unfairly by low-income and minority communities.
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. 642

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 ``Environmental Justice Act of
2007''.

SEC. 2. CODIFICATION OF EXECUTIVE ORDER 12898.

(a) In General.--The President of the United States is
authorized and directed to execute, administer and enforce as
a matter of Federal law the provisions of Executive Order
12898, dated February 11, 1994, (``Federal Actions To Address
Environmental Justice In Minority Populations and Low-Income
Populations'') with such modifications as are provided in
this section.
(b) Definition of Environmental Justice.--For purposes of
carrying out the provisions of Executive Order 12898, the
following definitions shall apply:
(1) The term ``environmental justice'' means the fair
treatment and meaningful involvement of all people regardless
of race, color, national origin, educational level, or income
with respect to the development, implementation, and
enforcement of environmental laws and regulations in order to
ensure that--
(A) minority and low-income communities have access to
public information relating to human health and environmental
planning, regulations and enforcement; and
(B) no minority or low-income population is forced to
shoulder a disproportionate burden of the negative human
health and environmental impacts of pollution or other
environmental hazard.
(2) The term ``fair treatment'' means policies and
practices that ensure that no group of people, including
racial, ethnic, or socioeconomic groups bear
disproportionately high and adverse human health or
environmental effects resulting from Federal agency programs,
policies, and activities.
(c) Judicial Review and Rights of Action.--The provisions
of section 6-609 of Executive Order 12898 shall not apply for
purposes of this Act.

SEC. 3. IMPLEMENTATION OF RECOMMENDATIONS BY ENVIRONMENTAL
PROTECTION AGENCY.

(a) Inspector General Recommendations.--The Administrator
of the Environmental Protection Agency shall, as promptly as
practicable, carry out each of the following recommendations
of the Inspector General of the agency as set forth in report
# 2006-P-00034 entitled ``EPA needs to conduct environmental
justice reviews of its programs, policies and activities'':
(1) The recommendation that the agency's program and
regional offices identify which programs, policies, and
activities need environmental justice reviews and require
these offices to establish a plan to complete the necessary
reviews.
(2) The recommendation that the Administrator of the agency
ensure that these reviews determine whether the programs,
policies, and activities may have a disproportionately high
and adverse health or environmental impact on minority and
low-income populations.
(3) The recommendation that each program and regional
office develop specific environmental justice review guidance
for conducting environmental justice reviews.
(4) The recommendation that the Administrator designate a
responsible office to compile results of environmental
justice reviews and recommend appropriate actions.
(b) GAO Recommendations.--In developing rules under laws
administered by the Environmental Protection Agency, the
Administrator of the Agency shall, as promptly as
practicable, carry out each of the following recommendations
of the Comptroller General of the United States as set forth
in GAO Report numbered GAO-05-289 entitled ``EPA Should
Devote More Attention to Environmental Justice when
Developing Clean Air Rules'':
(1) The recommendation that the Administrator ensure that
workgroups involved in developing a rule devote attention to
environmental justice while drafting and finalizing the rule.
(2) The recommendation that the Administrator enhance the
ability of such workgroups to identify potential
environmental justice issues through such steps as providing
workgroup members with guidance and training to helping them
identify potential environmental justice problems and
involving environmental justice coordinators in the
workgroups when appropriate.
(3) The recommendation that the Administrator improve
assessments of potential environmental justice impacts in
economic reviews by identifying the data and developing the
modeling techniques needed to assess such impacts.
(4) The recommendation that the Administrator direct
appropriate agency officers and employees to respond fully
when feasible to public comments on environmental justice,
including improving the agency's explanation of the basis for
its conclusions, together with supporting data.
(c) 2004 Inspector General Report.--The Administrator of
the Environmental Protection Agency shall, as promptly as
practicable, carry out each of the following recommendations
of the Inspector General of the agency as set forth in the
report entitled ``EPA Needs to Consistently Implement the
Intent of the Executive Order on Environmental Justice''
(Report No. 2004-P-00007):
(1) The recommendation that the agency clearly define the
mission of the Office of Environmental Justice (OEJ) and
provide agency staff with an understanding of the roles and
responsibilities of the office.
(2) The recommendation that the agency establish (through
issuing guidance or a policy statement from the
Administrator) specific time frames for the development of
definitions, goals, and measurements regarding environmental
justice and provide the regions and program offices a
standard and consistent definition for a minority and low-
income community, with instructions on how the agency will
implement and operationalize environmental justice into the
agency's daily activities.
(3) The recommendation that the agency ensure the
comprehensive training program currently under development
includes standard and consistent definitions of the key
environmental justice concepts (such as ``low-income'',
``minority'', and ``disproportionately impacted'') and
instructions for implementation of those concepts.
(d) Report.--The Administrator shall submit an initial
report to Congress within 6 months after the enactment of
this Act regarding the Administrator's strategy for
implementing the recommendations referred to in subsections
(a), (b), and (c). Thereafter, the Administrator shall
provide semi-annual reports to Congress regarding his
progress in implementing such recommendations as well as his
progress on modifying the Administrator's emergency
management procedures to incorporate environmental justice in
the agency's Incident Command Structure (in accordance with
the December 18, 2006, letter from the Deputy Administrator
to the Acting Inspector General of the agency).
______

By Mr. AKAKA:
S. 643. A bill to amend section 1922A of title 38, United States
Code, to increase the amount of supplemental insurance available for
totally disabled veterans; to the Committee on Veterans' Affairs.
Mr. AKAKA. Mr. President, today I introduce the Disabled Veterans
Insurance Improvement Act of 2007. The legislation would increase the
amount of supplemental life insurance available to totally disabled
veterans from $20,000 to $40,000. Many totally disabled veterans find
it difficult to obtain commercial life insurance. These are the
veterans we are trying to help with this legislation by providing them
with a reasonable amount of life insurance coverage.
VA's Service-Disabled Veterans' Insurance, commonly known as S-DVI,
was established during the Korean War to provide life insurance for
veterans with service-connected disabilities. This $10,000 benefit has
never been increased.
In comparison, the Servicemembers' Group Life Insurance and Veterans'
Group Life Insurance benefits, which were $10,000 and $20,000
respectively at their inception, have been increased over time to
$400,000. The most recent increases to these programs have been in
response to public sentiment and the determination by Congress that the
amount provided to the beneficiaries of servicemembers who die while
fighting in Operations Enduring Freedom and Iraqi Freedom is
insufficient.
In 1992, Congress increased the amount of life insurance available to
S-DVI policyholders by offering $20,000 worth of supplemental coverage
to those who are considered totally disabled. Forty percent of the
veterans enrolled in the S-DVI program are considered totally disabled
and are eligible for a premium waiver for their basic coverage. In
fiscal year 2006, thirty-two percent of veterans granted new policy
waivers also opted to pay for this supplemental coverage. Even with
$30,000 in coverage, the amount of life insurance available to disabled
veterans falls well short of the death benefits available to
servicemembers and veterans enrolled in the Servicemembers' Group Life
Insurance and Veterans' Group Life Insurance programs.
The 2001 Congressionally mandated study entitled Program Evaluation
of Benefits for Survivors of Veterans with

[[Page S2088]]

Service-Connected Disabilities found the lowest area of veteran
satisfaction to be the maximum amount of coverage that veterans were
authorized to purchase. My bill would allow totally disabled veterans
to purchase an additional $20,000 in insurance coverage.
I ask my colleagues to support the Disabled Veterans Insurance
Improvement Act of 2007. This is a modest and affordable way of
increasing the life insurance coverage for those veterans with the
greatest need. I realize that there are paygo implications associated
with this legislation and I am actively looking for ways to pay for
this bill.
I request 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. 643

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 ``Disabled Veterans Insurance
Act of 2007''.

SEC. 2. SUPPLEMENTAL INSURANCE FOR TOTALLY DISABLED VETERANS.

Section 1922A(a) of title 38, United States Code, is
amended by striking ``$20,000'' and inserting ``$40,000''.
______

By Mr. COLEMAN:
S. 646: A bill to increase the nursing workforce; to the Committee on
the Judiciary.
Mr. COLEMAN. 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. 646

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 ``Rural Nursing Promotion
Act''.

SEC. 2. ESTABLISHMENT OF A NURSE DISTANCE EDUCATION PILOT
PROGRAM.

(a) In General.--The Secretary of Health and Human
Services, in conjunction with the Secretary of Education,
shall establish a Nurse Distance Education Pilot Program
through which grants may be awarded for the conduct of
activities to increase accessibility to nursing education.
(b) Purpose.--The purpose of the Nurse Distance Education
Pilot Program established under subsection (a) shall be to
increase accessibility to nursing education to--
(1) provide assistance to individuals in rural areas who
want to study nursing to enable such individuals to receive
appropriate nursing education;
(2) promote the study of nursing at all educational levels;
(3) establish additional slots for nursing students at
existing nursing education programs; and
(4) establish new nursing education programs at
institutions of higher education.
(c) Application.--To be eligible to receive a grant under
the Pilot Program under subsection (a), an entity shall
submit to the Secretary of Health and Human Services an
application at such time, in such manner, and containing such
information as the Secretary may require.
(d) Authorization of Appropriations.--There is authorized
to be appropriated, such sums as may be necessary to carry
out this section.

SEC. 3. INCREASING THE DOMESTIC SUPPLY OF NURSES AND PHYSICAL
THERAPISTS.

(a) Not later than January 1, 2008, the Secretary of Health
and Human Services, in conjunction with the Secretary of
Education, shall--
(1) submit to Congress a report concerning the source of
newly licensed nurses and physical therapists in each State,
that shall include--
(A) for the most recent 3-year period for which data is
available--
(i) separate data relating to teachers at institutions of
higher education for each related occupation who have been
teaching for not more than 5 years; and
(ii) separate data relating to all teachers at institutions
of higher education for each related occupation regardless of
length of service;
(B) for the most recent 3-year period for which data is
available, separate data for each related occupation and for
each State;
(C) a description of the barriers to increasing the supply
of nursing faculty, domestically trained nurses, and
domestically trained physical therapists;
(D) separately identify those individuals receiving their
initial nursing license and those individuals licensed by
endorsement from another State;
(E) with respect to those individuals receiving their
initial nursing license in each year, a description of the
number of individuals who received their professional
education in the United States and the number of individuals
who received such education outside the United States;
(F) to the extent practicable, a description, by State of
residence and country of education, of the number of nurses
and physical therapists who were educated in any of the 5
countries (other than the United States) from which the most
nurses and physical therapists arrived;
(G) recommendations of strategies to be utilized by Federal
and State governments that would be effective in removing the
barriers described in subparagraph (C), including strategies
that address barriers to advancement to become registered
nurses for other health care workers, such as home health
aides and nurses assistants;
(H) recommendations for amendments to Federal laws that
would increase the supply of nursing faculty, domestically
trained nurses, and domestically trained physical therapists;
(I) recommendations for Federal grants, loans, and other
incentives that would provide increases in nurse educators
and nurse training facilities, and other measures to increase
the domestic education of new nurses and physical therapists;
(J) identify the effects of nurse emigration on the health
care systems in their countries of origin; and
(K) recommendation for amendments to Federal law that would
minimize the effects of health care shortages in the
countries of origin from which immigrant nurses arrived;
(2) enter into a contract with the Institute of Medicine of
the National Academy of Sciences for the conduct of a study,
and submission of a report, to determine the level of Federal
investment under titles VII and VIII of the Public Health
Service Act (42 U.S.C. 292 and 296 et seq.) that is necessary
to eliminate the domestic nursing and physical therapist
shortage by the date that is not later than 7 years after the
date on which the report is submitted; and
(3) collaborate with the heads of other Federal agencies,
as appropriate, in working with ministers of health or other
appropriate officials of the 5 countries from which the most
nurses and physical therapists arrived into the United
States, to--
(A) address health worker shortages caused by emigration;
and
(B) ensure that there is sufficient human resource planning
or other technical assistance needed to reduce further health
worker shortages in such countries.

SEC. 4. SHORTAGE OCCUPATIONS.

(a) Exception to Direct Numerical Limitations.--Section
201(b)(1) of the Immigration and Nationality Act (8 U.S.C.
1151(b)(1)) is amended by adding at the end the following new
subparagraph:
``(F)(i) During the period beginning on the date of the
enactment of the Rural Nursing Promotion Act and ending on
September 30, 2017, an alien--

``(I) who is described in section 203(b); and
``(II) who is seeking admission to the United States to
perform labor in shortage occupations designated by the
Secretary of Labor for certification under section
212(a)(5)(A) due to the lack of sufficient United States
workers able, willing, qualified, and available for such
occupations and for which the employment of aliens will not
adversely affect the terms and conditions of similarly
employed United States workers.

``(ii) During the period described in clause (i), the
spouse or dependent of an alien described in clause (i), if
accompanying or following to join such alien.''.
(b) Exception to Nondiscrimination Requirements.--Section
202(a)(1)(A) of the Immigration and Nationality Act (8 U.S.C.
1152(a)(1)(A)) is amended by striking ``201(b)(2)(A)(i)'' and
inserting ``201(b)''.
(c) Exception to Per Country Levels for Family-Sponsored
and Employment-Based Immigrants.--Section 202(a)(2) of the
Immigration and Nationality Act (8 U.S.C. 1152(a)(2)), is
amended by inserting ``, except for aliens described in
section 201(b),'' after ``any fiscal year''.
(d) Procedure for Granting Immigrant Status.--Section 204
of the Immigration and Nationality Act (8 U.S.C. 1154) is
amended by adding at the end the following new subsection:
``(l) The Secretary of Homeland Security shall provide a
process for reviewing and making a determination upon a
petition filed with respect to an alien described in section
201(b)(1)(F) not later than 30 days after the date a
completed petition has been filed for such alien.''.
______

By Mr. WYDEN (for himself and Mr. Smith):
S. 647. A bill to designate certain land in the State of Oregon as
wilderness, and for other purposes; to the Committee on Energy and
Natural Resources.
Mr. WYDEN. Mr. President, it has been more than 200 years since Lewis
and Clark first laid eyes on Mount Hood. Today, I propose, with Senator
Smith, that the spectacular mountain, seen first by our pioneers,
should be preserved for all time.
The Lewis and Clark Mount Hood Wilderness Act of 2007, which we
introduce today, is similar to the bill Senator Smith and I introduced
in the last Congress. It does include several improvements that came
about from comments and constructive suggestions

[[Page S2089]]

from a variety of groups at home in Oregon.
The legislation also includes input from the Energy and Natural
Resources Committee. We appreciate their input and believe their views
can help speed the bill's passage.
In tribute to the great river-dependent journey of Lewis and Clark,
our legislation adds nine free-flowing stretches of rivers to the
National Wild and Scenic River System. This reflects the views of
Oregonians, but, frankly, I hear it from folks in the Midwest, where
the Presiding Officer lives, and from people from every nook and cranny
in this country who have all come to treasure our spectacular mountain.
This legislation contains a number of provisions of the original
Mount Hood legislation I introduced in 2004. The bill protects the
lower elevation forests surrounding Mount Hood and the Columbia River
Gorge as Lewis and Clark saw them. These forests embody the natural
beauty of our home State. They provide the clean water necessary for
the survival of threatened steelhead, Coho, and Chinook salmon. They
provide critical habitat and diverse ecosystems for elk, deer, lynx,
and the majestic bald eagle. These are the forests that provide
unparalleled recreational opportunities for Oregonians and the scores
and scores of visitors we get from Minnesota and every other part of
the country as well.
But the legislation I offer today with Senator Smith differs from the
bill I introduced several years ago because it responds to the many
comments we have heard. We have received thousands of comments on our
proposed legislation. Some comments came as a result of the general
public meetings I held at home in Oregon. Many of the meetings lasted
over 3 hours. Everybody who wanted to speak was given the opportunity
to do so. Other comments came from the second Mount Hood summit that
was held at Timberline Lodge, hosted by Congressmen Walden and
Blumenauer. My staff and I met with over 100 community groups and local
governments, the members of the Oregon congressional delegation, the
Governor, and the Bush administration. More comments came from calls
and letters from Oregonians who are saying that now, now, now is the
time to preserve Mount Hood.
Overwhelmingly, these comments have urged that we build on Oregon's
wilderness system. This goal is as important today as it was in 1804,
when Lewis and Clark first viewed Mount Hood; in 1964, when the
Wilderness Act was passed; or in 1984, when wilderness protections were
last designated on Mount Hood. It is time to plan now to protect this
treasure for future generations.
The Mount Hood National Forest is the seventh most visited national
forest in our country. In the 22 years that have elapsed since any new
wilderness has been designated on Mount Hood, the population in the
local counties has increased significantly--25 percent in Multnomah
County, 24 percent in Hood River County, and 28 percent in Clackamas
County.
The predominant public use of this urban forest is nonmechanized
activities such as hiking, camping, and fishing. With increasing
emphasis on wild scenery, unspoiled wildlife habitats, free-flowing
rivers, wilderness, and the need for opportunities for diverse outdoor
recreation, sometimes it seems we are in jeopardy of loving our wild
places to death. We all see Americans coming together to make sure the
most special places are protected for future generations.
A few years ago, the Forest Service made a proposal to limit the
number of people who could hike on the south side of Mount Hood.
Suffice it to say, the public outcry in opposition was enormous. It
seems to me, rather than tell people they are going to be restricted
from using our public lands, part of the solution for Mount Hood lies
in providing more opportunities for them to enjoy the mountain's great
places. We ought to ensure that the Mount Hood National Forest can meet
the increased demand for outdoor experiences, and the legislation I
offer today with Senator Smith provides these opportunities. Hundreds
of people spoke at the public meetings I held throughout the State. I
have received 2,500 written comments urging additional wilderness on
Mount Hood. There are a few key areas the citizens continually come
back and refer to:
First, by astonishing numbers, they want to see additional wilderness
on Mount Hood. A large number of Oregonians didn't think enough
wilderness had been included, for example, in the legislation that was
considered by the other body.
A second area is mountain biking. Some mountain bikers expressed
concern that their recreation opportunities not be unfairly curtailed.
Senator Smith and I had many discussions with them to ensure that would
not be the case.
Third, fire protection and forest health was something referred to by
many Oregonians. Citizens were concerned about the health of the
forest. Those living in towns on the mountain and the gorge were
concerned about fire protection in their communities, and we sought to
address those issues as well.
An additional concern was developed recreation, with some citizens
worried about maintaining a role for developed recreation, such as
skiing, on Mount Hood.
In each of these areas, Senator Smith and I tried to follow up and be
responsive to what citizens at home were saying.
With respect to additional wilderness, there are currently 189,200
acres of designated wilderness in the Mount Hood National Forest. This
bill increases wilderness on Mount Hood by designating approximately
128,000 acres of new wilderness.
The bill adds the areas surrounding the oldest Mount Hood
wilderness--the mountain itself--which was designated in the original
Wilderness Act of 1964. These additions include cathedral old growth
forests, special trails, lava beds that were created during the Mount
Hood eruptions, and much of the legendary route that Oregon's pioneers
used when they came to our great State.
To the north and west of the mountain, we add the viewshed of the
Columbia Gorge to the current Mark O. Hatfield Wilderness. These areas
encompass the spectacular ridges that frame the gorge that we marvel at
from I-84 and include perhaps the greatest concentration of waterfalls
in all of North America.
To the southwest of the mountain, we add lands to the current Salmon
Huckleberry Wilderness to conserve their diverse wildlife and protect
unique recreational areas such as those around the extremely popular
Mirror Lake. These lands include Alder Creek, the source of drinking
water for the city of Sandy, and that city unanimously endorsed the
draft proposal.
Over to the east are proposed additions to the Badger Creek
Wilderness area. These areas provide a critical link between westside
forests and eastside ecosystems. This area is known for its spectacular
colors in the fall and the best deer and elk hunting in our entire
Mount Hood National Forest.
Among the areas we are protecting is the newly designated Richard L.
Kohnstamm Memorial area. It is dedicated in honor of Mr. Kohnstamm who
restored the historic Timberline Lodge built originally by the Works
Progress Administration in 1937. Our new 2007 bill adds 2,730 acres of
Marion County lands in the Bull of the Woods Wilderness Additions,
while removing lands where users identified potential conflicts.
Second, in the area of wild and scenic rivers, we protect over 79
miles of wild and scenic rivers on nine free-flowing rivers. This
protects some of the most pristine rivers in our State. Among those
proposed rivers are the picturesque waterfalls and glacial outwash of
the East Fork of the Hood River, and the ancestral hunting and fishing
grounds of Fish Creek. Over 17 miles of extraordinary salmon and
steelhead habitat on the Collowash River have also been added for
protection under our legislation.
Mountain biking is an area where there has been a lot of debate. We
believed the local riders raised valid concerns, and we took two steps.
First, we proposed the Mount Hood National Recreation Area. This area
was so popular in our last bill that Senator Smith and I decided to
greatly expand it to include 34,640 acres, an increase of over 16,000
additional acres. It is going to offer permanent environmental
protection to those beautiful areas, while

[[Page S2090]]

providing mountain bikers, recreational users, and others an
opportunity to enjoy recreation on the mountain.
Additionally, I made boundary adjustments to ensure that all open
mountain biking trails were not included in this proposed legislation.
With respect to fire protection and forest health, we tried to make
clear that where there are healthy, older trees, they should not be
harvested on Mount Hood or in the gorge. Older healthy stands are most
resistant to fire and disease. However, there is an enormous backlog of
overcrowded plantation, second growth that really ought to be thinned.
The legislation includes provisions that would give the Forest Service
a mandate to prepare an assessment for promoting forests resilient to
fire, insects, and disease. This also includes provisions to study and
encourage the development of biomass in conjunction with forest health
work.
We happen to think that biomass is one of the most exciting new
fields for Oregonians to get into. The opportunity to generate clean
energy, help small rural communities, create family wage jobs, is
something that we should not miss out on. This legislation tries to tap
the potential for progress in the biomass field as well.
Finally, we add fire-safe community zones so that the Secretary of
Agriculture will construct a system of fire-safe buffer zones around
the communities of Cascade Locks and Government Camp.
With respect to developed recreation, we wanted to facilitate
recreational opportunities in this area and thus adopted a provision
that came from the other body known as ``fee retention'' that would
establish a special account for the Mount Hood National Forest.
In addition, in order to help address growth while ensuring access to
recreational opportunities, we have adopted provisions originally
coming, again, from language from the other body directing the
Secretary of Agriculture and the State of Oregon to develop an
integrated transportation plan for the Mount Hood region.
I commend particularly my colleague in the other body, Congressman
Blumenauer, one of the real pioneers in thinking about transportation.
Finally, with respect to key relationships with our tribes and our
local governmental bodies, we have incorporated provisions on local and
tribal relationships, emphasizing the rich history of the Mount Hood
area and affirming the rights of Native peoples to access the mountains
as they have for generations.
The protections of these important Oregon places is going to depend
on the hard work and dedication of all Oregonians. I am very pleased--I
am summing up, and the Senate has been patient in giving me this extra
time--to say that this has been a bipartisan effort by the Oregon
congressional delegation. Senator Smith joins me in introducing this
legislation. We believe this brings together our county commissioners,
entrepreneurs, environmentalists, Chamber of Commerce, State-elected
officials, the Governor. All of those who feel so strongly about
protecting Mount Hood rolled up their sleeves, went to work, and joined
myself and Senator Smith to try to find common ground to make sure that
Mount Hood would be protected for all time.
We are looking forward to perfecting the legislation together in the
coming weeks and looking forward to seeing a swift adoption by
Congress.
The grandeur of Mount Hood and our special treasures is pretty much
in the chromosomes of Oregonians. Protecting our treasures is something
about which we feel so strongly. Today is a special day for us because,
once again, the citizens of our State have come together and have
worked with myself and Senator Smith to take action to protect our
treasures.
Mr. President, Oregon's Mount Hood is a cherished State treasure.
This wild place is often photographed, visited and enjoyed by scores of
Oregonians and non-Oregonians. Today, I am introducing, along with my
colleague Senator Smith, a bi-partisan Oregon Wilderness bill: the
``Lewis and Clark Mount Hood Wilderness Act of 2007.'' This bill is
similar to the one Senator Smith and I introduced in the last Congress,
but it includes several improvements that resulted from comments
received from stakeholders. The bill also includes input from the
Energy and Natural Resources Committee, which we hope will help speed
the bill's passage. In tribute to the great riverdependent journey of
Lewis and Clark, our legislation adds nine free-flowing stretches of
rivers to the National Wild and Scenic River System. This reflects the
Oregonian wish to protect but also actively experience our State's
treasures.
This bill contains many elements of the Mount Hood bill I introduced
in 2004, while also incorporating many new provisions to protect and
improve the Mount Hood region. This bill protects the lower elevation
forests surrounding Mount Hood and the Columbia River Gorge as Lewis
and Clark saw them. These forests embody the natural beauty of Oregon.
They provide the clean water necessary for the survival of threatened
steelhead, Coho and Chinook salmon. These forests provide critical
habitat and diverse ecosystems for elk, deer, lynx and the majestic
bald eagle. And these are the forests that provide unparalleled
recreational opportunities for Oregonians and our visitors.
But the bill I introduce today differs from the bill I introduced 2
years ago because it responds to the many comments I heard in the
ensuing years. I received thousands of comments on proposed Mount Hood
legislation. Some comments came as a result of the general public
meetings I held in Oregon. Many of the meetings lasted over 3 hours,
and everyone who wanted to speak was given an opportunity to do so.
Other comments came from the second Mount Hood Summit held at
Timberline Lodge hosted by Representatives Walden and Blumenauer. I and
my staff met with over 100 community groups and local governments, the
members of the Oregon congressional delegation, the Governor, and the
Bush administration. And still more comments came from letters and
phone calls from Oregonians.
Overwhelmingly, these comments urged me to protect and build on
Oregon's Wilderness system. This goal is as important today as it was
in 1804, when Lewis and Clark first viewed Mount Hood, 1964, when the
Wilderness Act was passed, or 1984, when wilderness protections were
last designated on Mount Hood--if not more so. To succeed, we must
provide the tools that help us create a planned future on Mount Hood.
This bill does both.
The Mount Hood National Forest is the seventh most visited National
Forest in the United States. In the 22 years that have elapsed since
any new wilderness has been designated in the Mount Hood area, the
population in local counties has increased significantly--25 percent in
Multnomah County, 24 percent in Hood River County, and 28 percent in
Clackamas County.
The predominant public use of this urban forest is non-mechanized
activity like hiking, camping, and fishing. With increasing emphasis on
wild scenery, unspoiled wildlife habitats, free flowing rivers,
wilderness and the need for opportunities for diverse outdoor
recreation, sometimes it seems we are in jeopardy of ``loving our wild
places to death.''
A few years ago, the Forest Service made a proposal to limit the
number of people that could hike the south side of Mount Hood and the
public outcry was enormous. Seems to me, rather than tell people that
they are going to be restricted from using our public lands, part of
the solution for the future of the Mountain lies in providing more
opportunities for them to enjoy the Mountain's great places. We should
ensure the Mount Hood National Forest can meet the increased use and
demand for outdoor experiences--my bill will provide those
opportunities.
Of the hundreds of people who attended the meetings I held throughout
the State of Oregon, the vast majority spoke in favor of more
wilderness. Additionally, I have received more than 2,500 written
comments supporting additional wilderness for Mount Hood.
This is what I have heard: First and foremost, I heard that
Oregonians in astonishing numbers support protecting Mount Hood and the
Columbia River Gorge with additional wilderness. A large number of
Oregonians didn't think that enough wilderness areas had been included
in the House proposal.

[[Page S2091]]

Some mountain bikers expressed concerns that their recreation
opportunities not be unfairly curtailed.
Some people were worried about forest health, and those living in
towns on the mountain and in the gorge were concerned about fire
protection for their communities.
Some people were worried about maintaining a role for developed
recreation, like skiing, on Mt. Hood.
This is what my bill does to address those concerns: There are
currently l89,200 acres of designated wilderness in the Mount Hood
National Forest. This bill increases wilderness on Mount Hood by
designating approximately 128,600 new acres of wilderness.
This bill adds the areas surrounding the oldest Mt. Hood Wilderness--
the mountain itself--which was designated in the original Wilderness
Act of 1964. These additions include cathedral old growth forests, the
historic Tilly Jane trail, lava beds that were created during the Mt.
Hood eruptions, and much of the legendary route that Oregon's pioneers
used when they were settling our great State. To the north and west of
the mountain, I would add the viewshed of the Columbia Gorge to the
current Mark O. Hatfield wilderness. These areas encompass the
spectacular ridges framing the Gorge that we all marvel at from 1-84
and include perhaps the greatest concentration of waterfalls in North
America. To the southwest of the mountain I add lands to the current
Salmon Huckleberry Wilderness to conserve their diverse wildlife and
protect unique recreational areas like those around popular Mirror
Lake. These lands include Alder Creek, the source of drinking water for
the City of Sandy, which unanimously endorsed the draft proposal. Over
to the east are proposed additions to the Badger Creek Wilderness.
These areas provide a critical link between Westside forests and
Eastside ecosystems. This area is known for beautiful fall color and
the best deer and elk hunting in the entire Mount Hood National Forest.
Among the areas we are protecting is the newly designated Richard L.
Kohnstamm Memorial Area. It is dedicated in honor of Mr. Kohnstamm who
restored the historic Timberline Lodge--built originally by the Works
Progress Administration in 1937--to its former grandeur. Our new 2007
bill adds 2730 acres of Marion County lands in the Bull of the Woods
Wilderness Additions, while removing lands where users identified
potential conflicts.

My proposal seeks to protect over 79.6 miles of wild and scenic
rivers on nine free flowing rivers. This includes some of the most
pristine and beautiful rivers in Oregon. Among those proposed rivers
are the picturesque waterfalls and glacial outwash of the East Fork of
the Hood River, and the ancestral hunting and fishing grounds of Fish
Creek. Over 17 miles of superb salmon and steelhead habitat on the
Collowash River have also been proposed for protection.
I believe that local riders raised some valid concerns, so I did two
things. I have proposed Mount Hood National Recreation Area. This area
was so popular in our last bill that Senator Smith and I decided to
greatly expand it to include 34,640 acres--an increase of over 16,700
acres. It will offer greater, permanent environmental protections to
those beautiful areas, while providing mountain bikers and other
recreational users an opportunity to continue to recreate in these
areas. Additionally, I made boundary adjustments to ensure all open
mountain biking trails were not included in my proposed wilderness.
I protect wilderness, where there are healthy, older trees that
should never be harvested on Mount Hood or in the Gorge. Older, healthy
stands are the most resistant to fire and disease. However, there is an
enormous backlog of over-crowded, plantation, second-growth that should
be thinned. My bill includes provisions that would give the Forest
Service a mandate to prepare an assessment for promoting forests
resilient to fire, insects and disease. This also includes provisions
to study and encourage the development of biomass in conjunction with
forest health work. In addition, I added fire safe community zones so
that the Secretary will construct a system of fire safe buffer zones
around the communities of Cascade Locks and Government Camp.
In order to facilitate developed recreation opportunities, I have
adopted the House provisions establishing a ``feeretention'' provision
that will establish an account for the Mount Hood National Forest. In
addition, in order to help address growth while ensuring access to
recreational opportunities, I have adopted provisions, originally
coming from the language passed in the House last Congress, directing
the Secretary and the State of Oregon to develop an integrated
transportation plan for the Mount Hood region.
I have also incorporated provisions on local and tribal relationships
emphasizing the rich history of the Mount Hood region and affirming the
rights of Native peoples to access the mountain's resources, as they
have for generations.
The protection of these important Oregon places will depend on the
hard work and dedication of all Oregonians and particularly that of my
Oregon colleagues here in the Congress. I am especially pleased that
Senator Smith has joined me in developing this bipartisan legislation
and putting forth our proposal for wilderness. I am hopeful everyone
will pull together: county Commissioners, environmentalists,
entrepreneurs, chambers of commerce, State elected officials, the
Governor, and the Oregon delegation here in the Capitol. I look forward
to perfecting legislation together in the coming weeks, and seeing its
swift adoption by Congress thereafter. Then the grandeur of Mount Hood
and other Oregon treasures can be assured for future generations.
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. 647

Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title.--This Act may be cited as the ``Lewis and
Clark Mount Hood Wilderness Act of 2007''.
(b) Table of Contents.--The table of contents of this Act
is as follows:

Sec. 1. Short title; table of contents.
Sec. 2. Definitions.

TITLE I--DESIGNATION OF WILDERNESS AREAS

Sec. 101. Designation of Lewis and Clark Mount Hood wilderness areas.
Sec. 102. Richard L. Kohnstamm Memorial Area.
Sec. 103. Map and legal descriptions.
Sec. 104. Administration.
Sec. 105. Buffer zones.
Sec. 106. Fire safe community zones.
Sec. 107. Fish and wildlife; hunting and fishing.
Sec. 108. Fire, insects, and diseases.
Sec. 109. Land reclassification.
Sec. 110. Valid existing rights and withdrawal.
Sec. 111. Maintenance and replacement of foot bridges in wilderness
areas.

TITLE II--DESIGNATION OF STREAMS FOR WILD AND SCENIC RIVER PROTECTION
IN THE MOUNT HOOD AREA

Sec. 201. Purpose.
Sec. 202. Wild and Scenic River designations, Mount Hood National
Forest.
Sec. 203. Impact on water rights and flow requirements.
Sec. 204. Culvert replacement.
Sec. 205. Protection for Hood River, Oregon.

TITLE III--MOUNT HOOD NATIONAL RECREATION AREA

Sec. 301. Designation.

TITLE IV--TRANSPORTATION AND COMMUNICATION SYSTEMS

Sec. 401. Definition of Mount Hood region.
Sec. 402. Transportation plan.
Sec. 403. Study relating to gondola connection and intermodal
transportation center.
Sec. 404. Burial of power lines.
Sec. 405. Clarification of treatment of State highways.

TITLE V--LAND EXCHANGE

Subtitle A--Cooper Spur-Government Camp Land Exchange

Sec. 501. Purposes.
Sec. 502. Definitions.
Sec. 503. Cooper Spur-Government Camp land exchange.
Sec. 504. Concessionaires at the Inn at Cooper Spur and the Cooper Spur
Ski Area.

Subtitle B--Port of Cascade Locks Land Exchange

Sec. 511. Definitions.
Sec. 512. Land exchange, Port of Cascade Locks-Pacific Crest National
Scenic Trail.

Subtitle C--Hunchback Mountain Land Exchange and Boundary Adjustment

Sec. 521. Definitions.
Sec. 522. Hunchback Mountain land exchange, Clackamas County.
Sec. 523. Boundary adjustment.

[[Page S2092]]

TITLE VI--MOUNT HOOD NATIONAL FOREST AND WATERSHED STEWARDSHIP

Sec. 601. Findings and purpose.
Sec. 602. Forest stewardship assessment.
Sec. 603. Sustainable biomass utilization study.
Sec. 604. Watershed management memoranda of understanding.
Sec. 605. Termination of authority.

TITLE VII--CRYSTAL SPRINGS WATERSHED SPECIAL RESOURCES MANAGEMENT UNIT

Sec. 701. Findings and purpose.
Sec. 702. Establishment of Crystal Springs Watershed Special Resources
Management Unit.
Sec. 703. Administration of Management Unit.
Sec. 704. Acquisition of lands.
Sec. 705. Effective date.

TITLE VIII--LOCAL AND TRIBAL RELATIONSHIPS

Sec. 801. Findings and purpose.
Sec. 802. First foods gathering areas.
Sec. 803. Forest Service coordination with State and local governments.
Sec. 804. Savings provisions regarding relations with Indian tribes.
Sec. 805. Improved natural disaster preparedness.

TITLE IX--RECREATION

Sec. 901. Findings and purpose.
Sec. 902. Retention of Mount Hood National Forest land use fees from
special use authorizations.
Sec. 903. Use of funds in special account to support recreation.
Sec. 904. Annual reporting requirement.
Sec. 905. Mount Hood National Forest Recreational Working Group.
Sec. 906. Consideration of conversion of forest roads to recreational
uses.
Sec. 907. Improved trail access for persons with disabilities.

TITLE X--AUTHORIZATION OF APPROPRIATIONS

Sec. 1001. Authorization of appropriations.

SEC. 2. DEFINITIONS.

In this Act:
(1) Indian tribe.--The term ``Indian tribe'' has the
meaning given the term in section 4 of the Indian Self-
Determination and Education Assistance Act (25 U.S.C. 450b).
(2) Mountain bike.--The term ``mountain bike'' does not
include a motorized vehicle.
(3) Secretary.--The term ``Secretary'' means--
(A) when used in reference to Forest Service land, the
Secretary of Agriculture; and
(B) when used in reference to Bureau of Land Management
land, the Secretary of the Interior.
(4) State.--The term ``State'' means the State of Oregon.

TITLE I--DESIGNATION OF WILDERNESS AREAS

SEC. 101. DESIGNATION OF LEWIS AND CLARK MOUNT HOOD
WILDERNESS AREAS.

In accordance with the Wilderness Act (16 U.S.C. 1131 et
seq.), the following areas in the State are designated as
wilderness areas and as components of the National Wilderness
Preservation System:
(1) Badger creek wilderness additions.--Certain Federal
land managed by the Forest Service, comprising approximately
4,139 acres, as generally depicted on the maps entitled
``Badger Creek'' and ``Bonney Butte'', dated February 2007,
which are incorporated in, and considered to be a part of,
the Badger Creek Wilderness, as designated by section 3(3) of
the Oregon Wilderness Act of 1984 (16 U.S.C. 1132 note; 98
Stat. 273).
(2) Bull of the woods wilderness addition.--Certain Federal
land managed by the Forest Service, comprising approximately
9,814 acres, as generally depicted on the map entitled ``Bull
of the Woods'', dated February 2007, which is incorporated
in, and considered to be a part of, the Bull of the Woods
Wilderness, as designated by section 3(4) of the Oregon
Wilderness Act of 1984 (16 U.S.C. 1132 note; 98 Stat. 273).
(3) Clackamas wilderness.--Certain Federal land managed by
the Forest Service and Bureau of Land Management, comprising
approximately 11,532 acres, as generally depicted on the maps
entitled ``Clackamas Canyon'', ``Big Bottom'', ``Memaloose
Lake'', ``South Fork Clackamas'', ``Sisi Butte'', and ``Upper
Big Bottom'', dated February 2007, which shall be known as
the ``Clackamas Wilderness''.
(4) Mark o. hatfield wilderness additions.--Certain Federal
land managed by the Forest Service, comprising approximately
25,807 acres, as generally depicted on the maps entitled
``Gorge Face'' and ``Larch Mountain'', dated February 2007,
which shall be known as the ``Mark O. Hatfield Wilderness
Additions''.
(5) Mount hood wilderness additions.--Certain Federal land
managed by the Forest Service, comprising approximately
20,230 acres, as generally depicted on the maps entitled
``Elk Cove/Mazama'', ``Sandy Additions'', ``Tilly Jane'',
``Sand Canyon'', ``Twin Lakes'', ``Barlow Butte'', ``White
River'', and ``Richard L. Kohnstamm Memorial Area'', dated
February 2007, which are incorporated in, and considered to
be a part of, the Mount Hood Wilderness as designated under
section 3(a) of the Wilderness Act (16 U.S.C. 1132(a)), and
enlarged by section 3(d) of the Endangered American
Wilderness Act of 1978 (16 U.S.C. 1132 note; 92 Stat. 43).
(6) Roaring river wilderness.--Certain Federal land managed
by the Forest Service, comprising approximately 37,590 acres,
as generally depicted on the map entitled ``Roaring River
Wilderness'', dated February 2007, which shall be known as
the ``Roaring River Wilderness''.
(7) Salmon-huckleberry wilderness additions.--Certain
Federal land managed by the Forest Service, comprising
approximately 16,704 acres, as generally depicted on the maps
entitled ``Alder Creek Addition'', ``Eagle Creek Addition'',
``Mirror Lake'', ``Inch Creek'', ``Salmon River Meadows'',
and ``Hunchback Mountain'', dated February 2007, which are
incorporated in, and considered to be a part of, the Salmon-
Huckleberry Wilderness, as designated by section 3(2) of the
Oregon Wilderness Act of 1984 (16 U.S.C. 1132 note; 98 Stat.
273).
(8) Lower white river wilderness.--Certain Federal land
managed by the Forest Service and Bureau of Land Management,
comprising approximately 2,844 acres, as generally depicted
on the map entitled ``Lower White River'', dated February
2007, which shall be known as the ``Lower White River
Wilderness''.

SEC. 102. RICHARD L. KOHNSTAMM MEMORIAL AREA.

(a) Designation.--Certain Federal land managed by the
Forest Service, as generally depicted on the map entitled
``Richard L. Kohnstamm Wilderness'', dated February 2007, and
including approximately 157 acres of designated wilderness,
as generally depicted on the map entitled ``Richard L.
Kohnstamm Wilderness'', dated February 2007, shall be known
and designated as the ``Richard L. Kohnstamm Wilderness''.
(b) References.--Any reference in a law, map, regulation,
document, paper, or other record of the United States to an
area described in subsection (a) shall be deemed to be a
reference to the Richard L. Kohnstamm Wilderness.
(c) Boundary.--
(1) In general.--The memorial area shall consist of land
located within the boundary depicted on the map entitled
``Richard L. Kohnstamm Wilderness'', dated February 2007.
(2) Availability of map.--The map shall be on file and
available for public inspection in the appropriate offices of
the Forest Service.

SEC. 103. MAP AND LEGAL DESCRIPTIONS.

(a) In General.--As soon as practicable after the date of
enactment of this Act, the Secretary shall file a map
entitled ``Lewis and Clark Mount Hood Wilderness Additions of
2007'', dated February 2007, and a legal description of each
wilderness area designated by this title, with--
(1) the Committee on Energy and Natural Resources of the
Senate; and
(2) the Committee on Natural Resources of the House of
Representatives.
(b) Force of Law.--The map and legal descriptions filed
under subsection (a) 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 each legal
description.
(c) Public Availability.--Each map and legal description
filed under subsection (a) shall be on file and available for
public inspection in the appropriate offices of the Forest
Service and Bureau of Land Management.
(d) Description of Lands.--The boundaries of the areas
designated as wilderness by section 101 where generally
depicted on the map as immediately adjacent to a utility
right of way or a Federal Energy Regulatory Commission
project boundary shall be 100 feet from the boundary of the
right of way.

SEC. 104. ADMINISTRATION.

(a) In General.--Subject to valid existing rights, each
area designated as wilderness by this Act 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 that has jurisdiction over the wilderness.
(b) Consistent Interpretation to the Public.--
Notwithstanding their separate jurisdictions, the Secretary
of Agriculture and the Secretary of the Interior shall
collaborate to ensure that the wilderness areas designated by
this title, if appropriate, are interpreted for the public as
an overall complex related by--
(1) common location in the Mount Hood-Columbia River Gorge
region;
(2) the abundant history of Native American use;
(3) the epic journey of Lewis and Clark;
(4) the pioneer settlement and growth of the State; and
(5) water sources for more than 40 percent of the residents
of the State.
(c) Incorporation of Acquired Land and Interests.--Any land
within the boundary of a wilderness area designated by this
Act that is acquired by the Federal Government shall--
(1) become part of the wilderness area in which the land is
located; and
(2) be managed in accordance with this Act, the Wilderness
Act (16 U.S.C. 1131 et seq.), and any other applicable law.
(d) Wilderness Areas Designated in National Recreation
Areas.--Any portion of a wilderness area designated by
section 101(a) that is located within a national recreation
area shall be administrated in accordance with the Wilderness
Act (16 U.S.C. 1131 et seq.).

[[Page S2093]]

SEC. 105. BUFFER ZONES.

(a) In General.--As provided in the Oregon Wilderness Act
of 1984 (16 U.S.C. 1132 note; Public Law 98-328), Congress
does not intend for designation of wilderness areas in the
State under this title to lead to the creation of protective
perimeters or buffer zones around each wilderness area.
(b) Activities or Uses up to Boundaries.--The fact that
nonwilderness activities or uses can be seen or heard from
within a wilderness area shall not, of itself, preclude the
activities or uses up to the boundary of the wilderness area.

SEC. 106. FIRE SAFE COMMUNITY ZONES.

Consistent with the Mount Hood National Forest Management
Plan and the Healthy Forests Restoration Act of 2003 (16
U.S.C. 6501 et seq.), the Secretary shall construct a
strategic system of defensible fuel profile zones (including
shaded fuelbreaks, thinning, individual tree selection, and
other methods of vegetation management) between the
wilderness boundary and the community boundary around Cascade
Locks and Government Camp.

SEC. 107. FISH AND WILDLIFE; HUNTING AND FISHING.

As provided in section 4(d)(7) of the Wilderness Act (16
U.S.C. 1133(d)(7)), nothing in this section shall be
construed as affecting the jurisdiction or responsibilities
of the State with respect to fish and wildlife in the State.

SEC. 108. FIRE, INSECTS, AND DISEASES.

As provided in section 4(d)(1) of the Wilderness Act (16
U.S.C. 1133(d)(1)), within the wilderness areas designated by
this Act, the Secretary of Agriculture (in collaboration with
the Secretary of the Interior, where appropriate) may take
such measures as are necessary to control fire, insects, and
diseases, subject to such terms and conditions as the
Secretary of Agriculture (in collaboration with the Secretary
of the Interior where appropriate) determines to be desirable
and appropriate.

SEC. 109. LAND RECLASSIFICATION.

(a) Oregon and California Railroad Land.--Not later than
180 days after the date of enactment of this Act, the
Secretary of Agriculture and the Secretary of the Interior
shall identify any Oregon and California Railroad Land that
is subject to section 201 of the Act of August 28, 1937 (43
U.S.C. 1181f), within the boundary of the Clackamas
Wilderness, as generally depicted on the map entitled ``South
Fork Clackamas'', dated February 2007.
(b) Public Domain Land.--
(1) Definition of public domain land.--In this section, the
term ``public domain land''--
(A) has the meaning given the term ``public land'' in
section 103 of the Federal Land Policy and Management Act of
1976 (43 U.S.C. 1702); and
(B) does not include any land managed under the Act of
August 28, 1937 (43 U.S.C. 1181a et seq.).
(2) Identification.--Not later than 180 days after the date
of enactment of this Act, the Secretary of the Interior shall
identify public domain land within the State that--
(A) is approximately equal in acreage of land described in
subsection (a); and
(B) would be appropriate for administration in accordance
with the Act of August 28, 1937 (43 U.S.C. 1181a et seq.).
(3) Maps.--Not later than 180 days after the date of
enactment of this Act, the Secretary of the Interior shall
submit to Congress and publish in the Federal Register, 1 or
more maps depicting the land identified under subsections (a)
and this subsection.
(4) Reclassification.--After providing an opportunity for
public comment, the Secretary of the Interior shall
administratively reclassify--
(A) the land described in subsection (a) as public domain
land that is not subject to section 201 of the Act of August
28, 1937 (43 U.S.C. 1181f); and
(B) the land described in this subsection as Oregon and
California Railroad Land that is subject to the Act of August
28, 1937 (43 U.S.C. 1181a et seq.).

SEC. 110. VALID EXISTING RIGHTS AND WITHDRAWAL.

Subject to valid rights in existence on the date of
enactment of this Act, the Federal land designated as
wilderness by this Act 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. 111. MAINTENANCE AND REPLACEMENT OF FOOT BRIDGES IN
WILDERNESS AREAS.

(a) In General.--In the case of each wilderness area
designated or expanded by section 102, it is the intent of
Congress that the Secretary be able to provide for--
(1) the maintenance of any foot bridge crossing located in
a wilderness area; and
(2) when needed, the replacement of the foot bridge
crossings to ensure public access and safety.
(b) Minimum Tool Policies.--The Secretary shall carry out
foot bridge replacement and maintenance work under subsection
(a) subject to the minimum requirement for the administration
of the area.

TITLE II--DESIGNATION OF STREAMS FOR WILD AND SCENIC RIVER PROTECTION
IN THE MOUNT HOOD AREA

SEC. 201. PURPOSE.

The purpose of this title is to designate approximately 81
miles of waterways in the Mount Hood National Forest as
additions to the National Wild and Scenic Rivers System.

SEC. 202. WILD AND SCENIC RIVER DESIGNATIONS, MOUNT HOOD
NATIONAL FOREST.

Section 3(a) of the Wild and Scenic Rivers Act (16 U.S.C.
1274(a)) is amended--
(1) by redesignating paragraph (167) (relating to the
Musconetcong River, New Jersey) as paragraph (169);
(2) by designating the undesignated paragraph relating to
the White Salmon River, Washington, as paragraph (167);
(3) by designating the undesignated paragraph relating to
the Black Butte River, California, as paragraph (168); and
(4) by adding at the end the following:
``(170) South fork clackamas river.--The 4.2-mile segment
of the South Fork Clackamas River from its confluence with
the East Fork of the South Fork Clackamas to its confluence
with the Clackamas River, to be administered by the Secretary
as a wild river.
``(171) Eagle creek.--The 8.3-mile segment of Eagle Creek
from its headwaters to the Mount Hood National Forest
boundary, to be administered by the Secretary of Agriculture
as a wild river.
``(172) Middle fork hood river.--The 3.7-mile segment of
the Middle Fork Hood River from the confluence of Clear and
Coe Branches to the north section line of section 11,
township 1 south, range 9 east, to be administered by the
Secretary of Agriculture as a scenic river.
``(173) South fork roaring river.--The 4.6-mile segment of
the South Fork Roaring River from its headwaters to its
confluence with Roaring River, to be administered by the
Secretary of Agriculture as a wild river.
``(174) Zig zag river.--The 2.9-mile segment of the Zig Zag
River from its headwaters to the Mount Hood Wilderness
boundary, to be administered by the Secretary of Agriculture
as a wild river.
``(175) Fifteenmile creek.--
``(A) In general.--The 11.1-mile segment of Fifteenmile
Creek from its source at Senecal Spring to the eastern edge
of the northwest quarter of section 20, township 2 south,
range 12 east, to be administered by the Secretary of
Agriculture in the following classes:
``(i) the 2.6-mile segment from its source at Senecal
Spring to the Badger Creek Wilderness boundary, as a wild
river;
``(ii) the 0.4-mile segment from the Badger Creek
Wilderness boundary to the point 0.4 miles downstream, as a
scenic river;
``(iii) the 7.9-mile segment from the point 0.4 miles
downstream of the Badger Creek Wilderness boundary to the
western edge of section 20, township 2 south, range 12 east
as a wild river; and
``(iv) the 0.2-mile segment from the western edge of
section 20, township 2 south, range 12 east, to the eastern
edge of the northwest quarter of the northwest quarter of
section 20, township 2 south, range 12 east as a scenic
river.
``(B) Inclusions.--Notwithstanding section 3(b) of this
Act, the lateral boundaries of both the wild river area and
the scenic river area along Fifteenmile Creek shall include
an average of not more than 640 acres per mile measured from
the ordinary high water mark on both sides of the river.
``(176) East fork hood river.--The 13.5-mile segment of the
East Fork Hood River from Oregon State Highway 35 to the
Mount Hood National Forest boundary, to be administered by
the Secretary of Agriculture as a recreational river.
``(177) Collawash river.--The 17.8-mile segment of the
Collawash River from the headwaters of the East Fork
Collawash to the confluence of the mainstream of the
Collawash River with the Clackamas River, to be administered
in the following classes:
``(A) the 11.0-mile segment from the headwaters of the East
Fork Collawash River to Buckeye Creek, as a scenic river; and
``(B) the 6.8-mile segment from Buckeye Creek to the
Clackamas River, as a recreational river.
``(178) Fish creek.--The 13.5-mile segment of Fish Creek
from its headwaters to the confluence with the Clackamas
River, to be administered by the Secretary of Agriculture as
a recreational river.''.

SEC. 203. IMPACT ON WATER RIGHTS AND FLOW REQUIREMENTS.

(a) Relation to Existing Requirements.--Congress does not
intend for the designation of any portion of the Hood River
under section 3(a) of the Wild and Scenic Rivers Act (16
U.S.C. 1274(a)), as amended by this Act, to have any impact
on any water right or flow requirement relating to--
(1) the Middle Fork Irrigation District;
(2) the East Fork Irrigation District; or
(3) the Mt. Hood Meadows Ski Resort.
(b) Exclusion of Operational Areas.--Congress does not
intend for the designation of any portion of the Hood River
under section 3(a) of the Wild and Scenic Rivers Act (16
U.S.C. 1274(a)), as amended by this Act, to include any
portion of the operational area of--
(1) the Middle Fork Irrigation District;
(2) the East Fork Irrigation District; or
(3) the Mt. Hood Meadows Ski Resort.

SEC. 204. CULVERT REPLACEMENT.

Culvert replacement carried out by the Forest Service or
the Bureau of Land Management to improve fish passage and the
ecology of the wilderness designated by this Act shall not be
considered water and resource development.

[[Page S2094]]

SEC. 205. PROTECTION FOR HOOD RIVER, OREGON.

Section 13(a)(4) of the ``Columbia River Gorge National
Scenic Area Act'' (16 U.S.C. 544k(a)(4)) is amended by
striking ``for a period not to exceed twenty years from the
date of enactment of this Act,''.

TITLE III--MOUNT HOOD NATIONAL RECREATION AREA

SEC. 301. DESIGNATION.

(a) Designation.--In order to best provide for the
protection, preservation, and enhancement of its
recreational, ecological, scenic, watershed, and fish and
wildlife values, there is hereby established the Mount Hood
National Recreation Area within the Mount Hood National
Forest.
(b) Boundary.--The Mount Hood National Recreation Area
shall consist of land located within the boundary depicted on
the map entitled ``Mount Hood National Recreation Area'' and
dated February 2007.
(c) Availability of Map.--The map shall be on file and
available for public inspection in the appropriate offices of
the Forest Service and Bureau of Land Management.
(d) Administration.--The Secretary shall administer the
Mount Hood National Recreation Area in accordance with the
laws, rules and regulations applicable to the national
forests and the purposes and values identified in subsection
(a). The Secretary shall only allow such uses as are
consistent with the purposes and values identified in
subsection (a).
(e) Timber.--The cutting, sale, or removal of timber within
the Mount Hood National Recreation Area may be permitted--
(1) to the extent necessary to improve the health of the
forest in a manner that--
(A) maximizes the retention of large trees as appropriate
to the forest type, to the extent that those trees promote
stands that are fire-resilient and healthy;
(B) improves the habitats of threatened, endangered,
proposed, or sensitive species; or
(C) maintains or restores the composition and structure of
the ecosystem by reducing the risk of uncharacteristic
wildfire effects;
(2) to accomplish an approved management activity in
furtherance of the purposes established by this subsection,
if the cutting, sale, or removal of timber is incidental to
the management activity; or
(3) for de minimus personal or administrative use within
the Mount Hood National Recreation Area, where such use will
not impair the purposes established by this subsection.
(f) Road Construction.--No new or temporary roads are to be
constructed or reconstructed except where it is required--
(1) to protect the health and safety of individuals in
cases of an imminent threat of flood, fire, or any other
catastrophic event that, without intervention, would cause
the loss of life or property;
(2) to conduct environmental cleanup required by the
Federal Government;
(3) to allow for reserved or outstanding rights provided
for by a statute or treaty;
(4) to prevent irreparable resource damage by an existing
road;
(5) to rectify a hazardous road condition; or
(6) in conjunction with--
(A) the continuation, extension, or renewal of a mineral
lease on land that is under lease; or
(B) a new mineral lease that is issued immediately after
the expiration of an existing mineral lease.

TITLE IV--TRANSPORTATION AND COMMUNICATION SYSTEMS

SEC. 401. DEFINITION OF MOUNT HOOD REGION.

In this title, the term ``Mount Hood region'' means--
(1) Mount Hood and the other land located adjacent to the
mountain;
(2) any segment of the Oregon State Highway 26 corridor
that is located in or near Mount Hood National Forest;
(3) any segment of the Oregon State Highway 35 corridor
that is located in or near Mount Hood National Forest;
(4) each other road of the Forest Service, State, or county
that is located in and near Mount Hood National Forest; and
(5) any gateway community located adjacent to any highway
or road described in paragraph (2), (3), or (4).

SEC. 402. TRANSPORTATION PLAN.

(a) In General.--The Secretary shall participate with the
State, local governments, and other Federal agencies in the
development of an integrated, multimodal transportation plan
for the Mount Hood region to achieve comprehensive solutions
to transportation challenges in the Mount Hood region--
(1) to promote appropriate economic development;
(2) to preserve the landscape of the Mount Hood region; and
(3) to enhance public safety.
(b) Planning Process.--The transportation plan under
subsection (a) shall--
(1) conform with Federal and Oregon transportation planning
requirements; and
(2) be developed through a collaborative process,
preferably through the use of a commission composed of
interested persons appointed by the State, with
representation from the Forest Service and local governments
in the Mount Hood region.
(c) Scope of Plan.--The transportation plan under
subsection (a) shall address issues relating to--
(1) the transportation of individuals to and from areas
outside the Mount Hood region on major corridors traversing
that region; and
(2) the transportation of individuals to and from locations
that are located within the Mount Hood region.
(d) Contents of Plan.--At a minimum, the transportation
plan under subsection (a) shall consider--
(1) transportation alternatives between and among
recreation areas and gateway communities that are located
within the Mount Hood region;
(2) establishing park-and-ride facilities that shall be
located at gateway communities;
(3) establishing intermodal transportation centers to link
public transportation, parking, and recreation destinations;
(4) creating a new interchange on Oregon State Highway 26
that shall be located adjacent to or within Government Camp;
(5) designating, maintaining, and improving alternative
routes using Forest Service or State roads for--
(A) providing emergency routes; or
(B) improving access to, and travel within, the Mount Hood
region;
(6) reconstructing the segment of Oregon State Highway 35
that is located between Mineral Creek and Baseline Road to
address ongoing debris flow locations; and
(7) creating mechanisms for funding the implementation of
the transportation plan under subsection (a), including--
(A) funds provided by the Federal Government;
(B) public-private partnerships;
(C) incremental tax financing; and
(D) other financing tools that link transportation
infrastructure improvements with development.
(e) Completion of Plan.--Not later than 2 years after the
date on which funds are first made available to carry out
this section, the Secretary shall complete the transportation
plan under subsection (a).
(f) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section $2,000,000.

SEC. 403. STUDY RELATING TO GONDOLA CONNECTION AND INTERMODAL
TRANSPORTATION CENTER.

(a) Feasibility Study.--The Oregon Department of
Transportation, along with the participation of the
Secretary, shall carry out a study of the feasibility of
establishing--
(1) a gondola connection that--
(A) connects Timberline Lodge to Government Camp; and
(B) is located in close proximity to the site of the
historic gondola corridor; and
(2) an intermodal transportation center to be located in
close proximity to Government Camp.
(b) Consideration of Multiple Sites.--In carrying out the
feasibility study under subsection (a), the Secretary may
consider 1 or more sites.
(c) Reliance on Past Studies.--To the extent that prior
studies have been completed that can assist in the assessment
of the Gondola connection, those may be utilized.

SEC. 404. BURIAL OF POWER LINES.

Because of the incongruent presence of power lines adjacent
to wilderness areas, the Secretary may provide to Cascade
Locks and Hood River County funds through the Forest Service
State and Private Forestry program to bury ground power lines
adjacent to the Mount Hood wilderness areas, including
wilderness areas designated by this Act.

SEC. 405. CLARIFICATION OF TREATMENT OF STATE HIGHWAYS.

(a) Exclusion.--Any part of Oregon State Highway 35 or
other any other State highway in existence on the date of
enactment of this Act (including all existing rights-of-way
and 150 feet on each side of the centerline, whichever is
greater, that is adjacent to wilderness areas in the Mount
Hood National Forest, including wilderness areas designated
by this Act) shall be excluded from wilderness under this
Act.
(b) No Net Effect.--The designation of wilderness or wild
and scenic rivers under this Act or an amendment made by this
Act shall not limit or restrict the ability of the State, and
in consultation with the Forest Service--
(1) to operate, maintain, repair, reconstruct, protect,
realign, expand capacity, or make any other improvement to
Oregon State Highway 35 or any other State highway in
existence on the date of enactment of this Act;
(2) to use any site that is not within a highway right-of-
way to operate, maintain, repair, reconstruct, protect,
realign, expand capacity, or make any other improvement to
those highways; or
(3) to take any action outside of a highway right-of-way
that is necessary to operate, maintain, repair, reconstruct,
protect, realign, expand capacity, or make any other
improvement to those highways.
(c) Flood Plain.--Congress encourages the carrying out of
projects that will reduce the impact of Oregon State Highway
35 on the flood plain of the East Fork Hood River.

TITLE V--LAND EXCHANGE

Subtitle A--Cooper Spur-Government Camp Land Exchange

SEC. 501. PURPOSES.

The purposes of this subtitle are--
(1) to recognize the years of work by local residents and
political and business leaders from throughout the States of
Oregon and Washington to protect the north side of Mount
Hood; and
(2) to authorize the exchange of the Federal land and non-
Federal land.

[[Page S2095]]

SEC. 502. DEFINITIONS.

In this subtitle:
(1) County.--The term ``County'' means Hood River County,
Oregon.
(2) Exchange map.--The term ``exchange map'' means the map
entitled ``Cooper Spur-Government Camp Land Exchange'' and
dated September 2006.
(3) Federal land.--The term ``Federal land'' means--
(A) the parcel of approximately 80 acres of National Forest
System land in Mount Hood National Forest in Government Camp,
Clackamas County, Oregon, as depicted on the exchange map;
and
(B) the parcel of approximately 40 acres of National Forest
System land in Mount Hood National Forest in Government Camp,
Clackamas County, Oregon, as depicted on the exchange map.
(4) Mt. hood meadows.--The term ``Mt. Hood Meadows'' means
the Mt. Hood Meadows Oreg., Limited Partnership.
(5) Non-federal land.--The term ``non-Federal land''
means--
(A) the parcel of approximately 770 acres of private land
at Cooper Spur, as depicted on the exchange map;
(B) any buildings, furniture, fixtures, and equipment at
the Inn at Cooper Spur and the Cooper Spur Ski Area covered
by an appraisal described in section 503(d).
(6) Secretary.--The term ``Secretary'' means the Secretary
of Agriculture.
(7) Trail map.--The term ``trail map'' means the map
entitled ``Government Camp Trail Map'' and dated September
2006.

SEC. 503. COOPER SPUR-GOVERNMENT CAMP LAND EXCHANGE.

(a) Conveyance of Federal Land.--Subject to the provisions
of this section, if Mt. Hood Meadows offers to convey to the
United States all right, title, and interest of Mt. Hood
Meadows in and to the non-Federal land, the Secretary shall
convey to Mt. Hood Meadows all right, title, and interest of
the United States in and to the Federal land (other than any
easements reserved under subsection (g)).
(b) Conditions on Acceptance.--Title to the non-Federal
land to be acquired by the Secretary under this section must
be acceptable to the Secretary, and the conveyances shall be
subject to valid existing rights of record and such terms and
conditions the Secretary may prescribe. The non-Federal land
shall conform with the title approval standards applicable to
Federal land acquisitions.
(c) Applicable Law.--Except as otherwise provided in this
section, the Secretary shall carry out the land exchange
under this section in accordance with section 206 of the
Federal Land Policy and Management Act of 1976 (43 U.S.C.
1716).
(d) Appraisals.--
(1) In general.--As soon as practicable after the date of
enactment of this Act, the Secretary shall select an
appraiser to conduct an appraisal of the Federal land and
non-Federal land.
(2) Requirements.--An appraisal under paragraph (1) shall--
(A) be conducted in accordance with nationally recognized
appraisal standards, including--
(i) the Uniform Appraisal Standards for Federal Land
Acquisitions developed by the Interagency Land Acquisition
Conference; and
(ii) the Uniform Standards of Professional Appraisal
Practice;
(B) incorporate the dates of the appraisals of the Federal
land and non-Federal land performed in 2005 by Appraiser
Steven A. Hall, MAI, CCIM; and
(C) be approved by the Secretary, the County, and Mt. Hood
Meadows.
(e) Surveys.--
(1) In general.--The exact acreage and legal description of
the Federal land and non-Federal land shall be determined by
surveys approved by the Secretary.
(2) Costs.--The responsibility for the costs of any surveys
conducted under paragraph (1), and any other administrative
costs of carrying out the land exchange, shall be determined
by the Secretary and the County.
(f) Deadline for Completion of Land Exchange.--It is the
intent of Congress that, not later than 16 months after the
date of enactment of this Act, the Secretary shall--
(1) complete all legal and regulatory processes required
for the exchange of the Federal land and the non-Federal
land; and
(2) close on the Federal land and the non-Federal land.
(g) Reservation of Easements.--As a condition of the
conveyance of the Federal land, the Secretary shall reserve--
(1) a conservation easement to the Federal land to protect
existing wetland on the conveyed parcels, as identified by
the Oregon Department of State Lands, that allows equivalent
wetland mitigation measures to compensate for minor wetland
encroachments necessary for the orderly development of the
Federal land; and
(2) a trail easement to the Federal land that allows--
(A) the nonmotorized functional use by the public of
identified existing trails located on the Federal land, as
depicted on the trail map;
(B) roads, utilities, and infrastructure facilities to
cross the trails; and
(C) improvement or relocation of the trails to accommodate
development of the Federal land.

SEC. 504. CONCESSIONAIRES AT THE INN AT COOPER SPUR AND THE
COOPER SPUR SKI AREA.

(a) Prospectus.--Not later than 60 days after the date on
which the land exchange is completed under section 503, the
Secretary shall publish in the Federal Register a proposed
prospectus to solicit 1 or more new concessionaires for the
Inn at Cooper Spur and the Cooper Spur Ski Area, as
reconfigured in accordance with the exchange map.
(b) Competitive Process.--Prospective concessionaires shall
submit bids to compete for the right to operate the Inn at
Cooper Spur, the Cooper Spur Ski Area, or both the Inn and
the Ski Area.
(c) Considerations.--In selecting a concessionaire, the
Secretary shall consider--
(1) which bid is highest in terms of monetary value; and
(2) other attributes of the bids submitted.
(d) Consultation.--The Secretary shall consult with Mt.
Hood Meadows, Meadows North, LLC, North Face Inn, LLC, the
Hood River Valley Residents Committee, the Cooper Spur Wild
and Free Coalition, and the Hood River County Commission--
(1) in selecting a new concessionaire for the Inn at Cooper
Spur and the Cooper Spur Ski Area; and
(2) in preparing for the orderly and smooth transition of
the operation of the Inn at Cooper Spur and the Cooper Spur
Ski Area to the new concessionaire.
(e) Treatment of Proceeds.--Any amounts received under a
concession contract under this section shall--
(1) be deposited in the fund established under Public Law
90-171 (commonly known as the ``Sisk Act'') (16 U.S.C. 484a);
and
(2) remain available to the Secretary until expended,
without further appropriation, for use in the Mount Hood
National Forest, with priority given to using amounts in the
Hood River Ranger District for restoration projects on the
North side of Mount Hood.
(f) Alternative Conveyance and Special Use Permit.--
(1) In general.--If the Secretary has not selected a
concessionaire for the Inn at Cooper Spur and the Cooper Spur
Ski Area by the date that is 1 year after the date on which
the prospectus is published under subsection (a), the
Secretary may--
(A) convey to the County, without consideration, the
improvements described in section 502(5)(B); or
(B) continue to allow Mt. Hood Meadows to operate as the
concessionaire while the Secretary continues to seek an
alternate concessionaire.
(2) Special use permit.--If the Secretary conveys
improvements to the County under paragraph (1)(A), the
Secretary shall issue to the County a special use permit that
would allow reasonable access to, and management of, the
improvements under terms similar to the Cooper Spur Ski Area
Special Use Permit.

Subtitle B--Port of Cascade Locks Land Exchange

SEC. 511. DEFINITIONS.

In this subtitle:
(1) Exchange map.--The term ``exchange map'' means the map
entitled ``Port of Cascade Locks-Pacific Crest National
Scenic Trail Land Exchange'' and dated June 2006.
(2) Federal land.--The term ``Federal land'' means the
parcel of land consisting of approximately 10 acres of
National Forest System land in the Columbia River Gorge
National Scenic Area, as depicted on the exchange map.
(3) Non-federal land.--The term ``non-Federal land'' means
the parcel of land consisting of approximately 40 acres, as
depicted on the exchange map.
(4) Port.--The term ``Port'' means the Port of Cascade
Locks, Cascade Locks, Oregon.
(5) Secretary.--The term ``Secretary'' means the Secretary
of Agriculture.

SEC. 512. LAND EXCHANGE, PORT OF CASCADE LOCKS-PACIFIC CREST
NATIONAL SCENIC TRAIL.

(a) Conveyance Required.--Subject to the provisions of this
section, if the Port offers to convey to the United States
all right, title, and interest of the Port in and to the non-
Federal land, the Secretary shall convey to the Port all
right, title, and interest of the United States in and to the
Federal land.
(b) Compliance With Existing Law.--Except as otherwise
provided in this section, the Secretary shall carry out the
land exchange under this section in the manner provided in
section 206 of the Federal Land Policy Management Act of 1976
(43 U.S.C. 1716).
(c) Conditions on Acceptance.--Title to the non-Federal
land to be acquired by the Secretary under this section must
be acceptable to the Secretary, and the conveyances shall be
subject to valid existing rights of record and such terms and
conditions the Secretary may prescribe. The non-Federal land
shall conform with the title approval standards applicable to
Federal land acquisitions.
(d) Surveys.--
(1) In general.--The exact acreage and legal description of
the Federal land and non-Federal land shall be determined by
surveys approved by the Secretary.
(2) Costs.--The responsibility for the costs of any surveys
conducted under paragraph (1), and any other administrative
costs of carrying out the land exchange, shall be determined
by the Secretary and the Port.
(e) Deadline for Completion of Land Exchange.--It is the
intent of Congress that, not later than 16 months after the
date of enactment of this Act, the Secretary shall--
(1) complete all legal and regulatory processes required
for the exchange of the Federal land and the non-Federal
land; and

[[Page S2096]]

(2) close on the Federal land and the non-Federal land.

Subtitle C--Hunchback Mountain Land Exchange and Boundary Adjustment

SEC. 521. DEFINITIONS.

In this subtitle:
(1) Boundary extension map.--The term ``boundary extension
map'' means the map entitled ``Mount Hood National Forest
Hunchback Exchange Boundary Adjustment'' and dated January
2007.
(2) County.--The term ``County'' means Clackamas County,
Oregon.
(3) Exchange map.--The term ``exchange map'' means the map
entitled ``Hunchback Mountain Land Exchange-Clackamas
County'' and dated June 2006.
(4) Federal land.--The term ``Federal land'' means the
parcel of land consisting of approximately 160 acres of
National Forest System land in the Mount Hood National
Forest, as depicted on the exchange map.
(5) Non-federal land.--The term ``non-Federal land'' means
the parcel of land consisting of approximately 160 acres, as
depicted on the exchange map.
(6) Secretary.--The term ``Secretary'' means the Secretary
of Agriculture.

SEC. 522. HUNCHBACK MOUNTAIN LAND EXCHANGE, CLACKAMAS COUNTY.

(a) Conveyance Required.--Subject to the provisions of this
section, if the County offers to convey to the United States
all right, title, and interest of the County in and to the
non-Federal land, the Secretary shall convey to the County
all right, title, and interest of the United States in and to
the Federal land.
(b) Compliance With Existing Law.--Except as otherwise
provided in this section, the Secretary shall carry out the
land exchange under this section in the manner provided in
section 206 of the Federal Land Policy Management Act of 1976
(43 U.S.C. 1716).
(c) Conditions on Acceptance.--Title to the non-Federal
land to be acquired by the Secretary under this section must
be acceptable to the Secretary, and the conveyances shall be
subject to valid existing rights of record and such terms and
conditions the Secretary may prescribe. The non-Federal land
shall conform with the title approval standards applicable to
Federal land acquisitions.
(d) Surveys.--
(1) In general.--The exact acreage and legal description of
the Federal land and non-Federal land shall be determined by
surveys approved by the Secretary.
(2) Costs.--The responsibility for the costs of any surveys
conducted under paragraph (1), and any other administrative
costs of carrying out the land exchange, shall be determined
by the Secretary and the County.
(e) Deadline for Completion of Land Exchange.--It is the
intent of Congress that, not later than 16 months after the
date of enactment of this Act, the Secretary shall--
(1) complete all legal and regulatory processes required
for the exchange of the Federal land and the non-Federal
land; and
(2) close on the Federal land and the non-Federal land.

SEC. 523. BOUNDARY ADJUSTMENT.

(a) In General.--The boundary of the Mount Hood National
Forest is adjusted as depicted on the map entitled ``Boundary
extension map'', dated January 2007.
(b) Availability of Boundary Extension Map.--The boundary
extension map shall be on file and available for public
inspection in the office of the Chief of the Forest Service.
(c) Correction Authority.--The Secretary may make minor
corrections to the boundary extension map.
(d) Additions to the National Forest System.--The Secretary
shall administer any land that is conveyed to the United
States and is located in the Mount Hood National Forest in
accordance with--
(1) the Act of March 1, 1911 (commonly known as the ``Weeks
Law'') (16 U.S.C. 480 et seq.); and
(2) any laws (including regulations) applicable to the
National Forest System.
(e) Authority of Secretary to Adjust Boundaries.--Nothing
in this Act shall limit the authority or responsibility of
the Secretary to adjust the boundaries of the Mount Hood
National Forest under section 11 of the Act of March 1, 1911
(16 U.S.C. 521).
(f) Land and Water Conservation Fund.--For the purposes of
section 7 of the Land and Water Conservation Fund Act of 1965
(16 U.S.C. 460l-9), the boundaries of the Mount Hood National
Forest modified by this Act shall be considered to be the
boundaries of the Mount Hood National Forest in existence as
of January 1, 1965.

TITLE VI--MOUNT HOOD NATIONAL FOREST AND WATERSHED STEWARDSHIP

SEC. 601. FINDINGS AND PURPOSE.

The purpose of this title is to direct the Forest Service
to prepare an assessment to promote forested landscapes
resilient to catastrophic fire, insects, and disease, to
protect homes and communities from property damage and
threats to public safety, and to protect and enhance existing
community or municipal watersheds. It is the intent of
Congress that site-specific forest health projects undertaken
pursuant to this assessment shall be completed in accordance
with existing law.

SEC. 602. FOREST STEWARDSHIP ASSESSMENT.

(a) Preparation of Assessment.--The Secretary of
Agriculture shall prepare an assessment to identify the
forest health needs in those areas of the Mount Hood National
Forest with a high incidence of insect or disease infestation
(or both), heavily overstocked tree stands, or moderate-to-
high risk of unnatural catastrophic wildfire for the purpose
of improving condition class, which significantly improves
the forest health and water quality. The Secretary may
utilize existing information to complete the assessment. The
assessment shall also identify specific projects to address
these issues.
(b) Improved Mapping.--The assessment will include peer
reviewed mapping of condition class 2 and condition class 3
areas and other areas identified in subsection (a) in Mount
Hood National Forest.
(c) Completion.--The Secretary of Agriculture shall
complete the assessment not later than 1 year after the date
of enactment of this Act.
(d) Duration of Study.--The assessment shall cover a 10-
year period.
(e) Implementation.--Not later than 1 year after completion
of the assessment, the Secretary shall commence
implementation of projects to address the needs identified in
the assessment. These projects shall be implemented using
authorities available to the Secretary to manage the Mount
Hood National Forest to achieve the purpose specified in
subsection (a).
(f) Delay.--During development of the assessment under this
section, a forest management project that is unaffiliated
with the assessment and has completed review as required
under the National Environmental Policy Act of 1969 (42
U.S.C. 4321 et seq.) in accordance with existing law, need
not be delayed in the event the Secretary fails to meet the
deadline specified in subsection (c).
(g) Relation to Existing Law and Plans.--Nothing in this
section grants the Secretary any authority to manage the
Mount Hood National Forest contrary to existing law. The
assessment conducted by the Secretary under this section
shall not supersede, be considered a supplement or amendment
to, or in any way affect the legal or regulatory authority of
the Mount Hood National Forest Land and Resource Management
Plan or the collection of documents entitled ``Final
Supplemental Environmental Impact Statement and Record of
Decision for Amendments to Forest Service and Bureau of Land
Management Planning Documents Within the Range of the
Northern Spotted Owl'' and ``Standards and Guidelines for
Management of Habitat for Late-Successional and Old-Growth
Forest-Related Species Within the Range of the Northern
Spotted Owl''.
(h) Public Participation.--The Secretary shall provide an
opportunity for interested persons to be involved in
development of the assessment conducted by the Secretary
under this section.

SEC. 603. SUSTAINABLE BIOMASS UTILIZATION STUDY.

(a) Study Required.--The Secretary of Agriculture shall
conduct a study to assess the amount of long-term sustainable
biomass available in the Mount Hood National Forest that,
consistent with applicable law, could be made available as a
raw material for--
(1) the production of electric energy, sensible heat,
transportation fuel, or substitutes for petroleum-based
products;
(2) dimensional lumber, fencing, framing material, poles,
firewood, furniture, chips, or pulp for paper; or
(3) other commercial purposes.
(b) Definition.--In this section, the term ``biomass''
means small diameter trees and understory vegetation that is
removed from forested land as a by-product of forest
restoration efforts.

SEC. 604. WATERSHED MANAGEMENT MEMORANDA OF UNDERSTANDING.

(a) Completion of Memoranda of Understanding.--To the
extent that memoranda of understanding or other legal
agreements involving watersheds of Mount Hood National Forest
do not exist between irrigation districts or municipalities
and the Forest Service, the Secretary of Agriculture may
complete memoranda of understanding that outline stewardship
goals to manage the watersheds for water quality and water
quantity.
(b) Elements of Memorandum.--A memorandum of understanding
involving a watershed of Mount Hood National Forest shall
encourage adaptability, establish benchmarks regarding water
quality and water quantity, and require monitoring to
determine progress in meeting such benchmarks. The memorandum
of understanding may restrict public access to areas of the
watershed where appropriate.
(c) Public Process Required.--
(1) Collaboration and consultation.--The Secretary of
Agriculture shall ensure that the process by which the
Secretary enters into a memorandum of understanding with an
irrigation district, local government, or other entity
involving a watershed of Mount Hood National Forest is based
on collaboration and cooperation between the Forest Service
and local jurisdictions and other interested persons.
(2) Public meeting required.--The Secretary and the other
party or parties to the proposed memorandum of understanding
shall hold at least 1 joint public meeting before completing
a final draft of the memorandum of understanding.
(3) Public comment.--A draft memorandum of understanding
shall also be open to public comment before being finalized.

SEC. 605. TERMINATION OF AUTHORITY.

The authority provided by this title shall terminate on the
date that is 10 years after the date of enactment of this
Act.

[[Page S2097]]

TITLE VII--CRYSTAL SPRINGS WATERSHED SPECIAL RESOURCES MANAGEMENT UNIT

SEC. 701. FINDINGS AND PURPOSE.

The purpose of this title is to establish a special
resources management unit to ensure protection of the quality
and quantity of the Crystal Springs watershed as a clean
drinking water source for the residents of Hood River County,
Oregon, while also allowing visitors to enjoy its special
scenic, natural, cultural, and wildlife values.

SEC. 702. ESTABLISHMENT OF CRYSTAL SPRINGS WATERSHED SPECIAL
RESOURCES MANAGEMENT UNIT.

(a) Establishment.--Effective as provided by section 705,
the Secretary of Agriculture shall establish a special
resources management unit in the State consisting of all
National Forest System land that is located within 200 yards
from any point on the perimeter of the Crystal Springs Zone
of Contribution, as determined by the Crystal Springs Water
District, and other National Forest System land in and around
the Inn at Cooper Spur and the Cooper Spur Ski Area, as
depicted on the map entitled ``Crystal Springs Watershed
Special Resources Management Unit'' and dated June 2006 (in
this subtitle referred to as the ``official map'').
(b) Designation.--The special resources management unit
established pursuant to subsection (a) shall be known as the
Crystal Springs Watershed Special Resources Management Unit,
in this title referred to as the ``Management Unit''.
(c) Exclusion of Certain Land.--The Management Unit does
not include any National Forest System land otherwise covered
by subsection (a) that is designated as wilderness by title
I.
(d) Withdrawal.--Subject to valid existing rights, National
Forest System land included in the Management Unit are
permanently withdrawn from all forms of appropriation under
the public land laws, including the mining laws and mineral
and geothermal leasing laws.
(e) Maps and Legal Description.--
(1) Submission of legal descriptions.--As soon as
practicable after the effective date specified in section
705, the Secretary shall prepare and submit to Congress a
legal description of the Management Unit.
(2) Force of law.--The map referred to in subsection (a)
and the legal descriptions prepared under paragraph (1) shall
have the same force and effect as if included in this Act,
except that the Secretary may correct technical errors in the
map and legal descriptions. The map of the Crystal Springs
Zone of Contribution is incorporated in this Act to delineate
the boundaries of the Management Unit, and the delineation of
these boundaries is not intended to affect the specific uses
that may occur on private land within the boundaries of the
Management Unit.
(3) Public availability.--The map referred to in subsection
(a) and the legal descriptions prepared under paragraph (1)
shall be filed and made available for public inspection in
the appropriate offices of the Forest Service.

SEC. 703. ADMINISTRATION OF MANAGEMENT UNIT.

(a) General Applicability of Existing Laws.--Except as
provided in this title, all other laws and regulations
affecting National Forest System lands shall continue to
apply to the National Forest System lands included in the
Management Unit.
(b) Authorized Activities.--
(1) Process for allowing activities.--Only activities
described in this subsection may occur in the Management
Unit, and the Secretary of Agriculture may permit an activity
described in this subsection to occur in the Management Unit
only after the Secretary--
(A) obtains the review and opinions of the Crystal Springs
Water District regarding the effect of the activity on the
purposes of the Management Unit;
(B) complies with all applicable Federal law regarding
development and implementation of the activity; and
(C) when appropriate, provides to the general public
advance notice of the activity, an opportunity to comment on
the activity, and appeal rights regarding the activity.
(2) Recreation.--The Secretary may--
(A) continue to maintain recreational opportunities and
trails, in existence in the Management Unit as of the
effective date specified in section 705, within their
existing and historic footprints or at an alternative
location; and
(B) develop new footpaths or cross-county skiing trails in
the Management Unit.
(3) Lease of certain improvements.--The Secretary may lease
improvements and facilities, in existence in the Management
Unit as of the effective date specified in section 705,
within their existing and designated footprints to 1 or more
concessionaires.
(4) Road maintenance.--Subject to subsection (d), the
Secretary may maintain National Forest System roads, in
existence in the Management Unit as of the effective date
specified in section 705 or as directed by the management
plan required by subsection (d). Maintenance may include the
installation of culverts and drainage improvements and other
similar activities.
(5) Fuel reduction in proximity to improvements and primary
public roads.--To protect the water quality, water quantity,
scenic, cultural, historic, natural, and wildlife values of
the Management Unit, the Secretary may permit fuel reduction
on National Forest System land in the Management Unit--
(A) extending up to 400 feet from structures on National
Forest System land or structures on adjacent private land;
and
(B) extending up to 400 feet from the Cooper Spur Road, the
Cloud Cap Road, and the Cooper Spur ski area loop road.
(6) Other fuel reduction and forest health activities.--The
Secretary may conduct fuel reduction and forest health
management activities in the Management Unit, with priority
given to activities that restore previously harvested stands,
including the removal of logging slash, smaller diameter
material, and ladder fuels. The purpose of any fire risk
reduction or forest health management activity conducted in
the Management Unit shall be the maintenance and restoration
of fire-resilient forest structures containing late
successional forest structure characterized by large trees
and multi-storied canopies (where ecologically appropriate)
and the protection of the water quality, water quantity,
scenic, cultural, historic, natural, and wildlife values of
the Management Unit.
(c) Specifically Prohibited Activities.--The following
activities may not occur on National Forest System land in
the Management Unit, whether separately or, except as
provided in paragraph (2), as part of an activity authorized
by subsection (b):
(1) New road construction or renovation of existing non-
System roads.
(2) Projects undertaken for the purpose of harvesting
commercial timber. The harvest of merchantable products that
are by-products of activities conducted pursuant to
subsection (b)(6) and carried out pursuant to a stewardship
contract are not prohibited by this subsection.
(3) Commercial livestock grazing.
(4) The placement or maintenance of fuel storage tanks.
(5) The application of any toxic chemicals, including
pesticides, rodenticides, herbicides, or retardants, for any
purpose, except with the consent of the Crystal Springs Water
District.
(d) Management Plan.--
(1) Plan required.--Within 9 months after the effective
date specified in section 605, the Secretary of Agriculture
shall adopt a management plan for the Management Unit that,
while providing for the limited activities specifically
authorized by subsection (b), protects the watershed from
illegal dumping, human waste, fires, vandalism, and other
risks to water quality.
(2) Consultation and public participation.--The Secretary
shall prepare the management plan in consultation with the
Crystal Springs Water District, the Cooper Spur Wild and Free
Coalition, and Hood River County and provide for public
participation as described in subsection (b)(1)(C).
(e) Forest Road Closures.--As part of the management plan
required by subsection (d), the Secretary of Agriculture may
provide for the closure or gating to the general public of
any Forest Service road within the Management Unit, except
for the road commonly known as Cloud Cap Road.
(f) Private Land.--Nothing in this section affects the use
of, or access to, any private property within the Crystal
Springs Zone of Contribution by the owners of the private
property and their guests. The Secretary is encouraged to
work with interested private landowners who have voluntarily
agreed to cooperate with the Secretary to further the
purposes of this title.
(g) Relationship With Water District.--Except as provided
in this section, the Crystal Springs Water District has no
authorities over management or use of National Forest System
land included in the Management Unit.

SEC. 704. ACQUISITION OF LANDS.

(a) Acquisition Authority.--The Secretary of Agriculture
may acquire from willing landowners any lands located in the
Crystal Springs Zone of Contribution within the boundaries of
Mount Hood National Forest. Lands so acquired shall
automatically be added to the Management Unit.
(b) Prohibition on Subsequent Conveyance.--The Secretary
may not sell, trade, or otherwise transfer ownership of any
land within the Management Unit, including any of the land
acquired under subsection (a) or received by the Secretary as
part of the Cooper Spur-Government Camp land exchange
authorized by subtitle A of title V and included within the
Management Unit, to any person.

SEC. 705. EFFECTIVE DATE.

The Secretary of Agriculture shall establish the Management
Unit as soon as practicable after the final closing of the
Cooper Spur-Government Camp land exchange authorized by
subtitle A of title V, but in no case later than 30 days
after the date of the final closing of such land exchange.
The Management Unit may not be established before final
closing of the land exchange.

TITLE VIII--LOCAL AND TRIBAL RELATIONSHIPS

SEC. 801. FINDINGS AND PURPOSE.

The purpose of this title is to recognize and support the
ability of Native Americans to continue to gather first foods
in the Mount Hood National Forest using traditional methods
and the central role of the State and local governments in
management of issues dealing with natural and developed
environments in the vicinity of the national forest.

[[Page S2098]]

SEC. 802. FIRST FOODS GATHERING AREAS.

(a) Priority Use Areas.--The Secretary of Agriculture shall
identify, establish, develop, and manage priority-use areas
in Mount Hood National Forest for the gathering of first
foods by members of Indian tribes with treaty-reserved
gathering rights on lands encompassed by the national forest.
The priority-use areas shall be identified, established,
developed, and managed in a manner consistent with the
memorandum of understanding entered into between the
Department of Agriculture, the Bureau of Land Management, the
Bureau of Indian Affairs, and the Confederated Tribes of the
Warm Springs Reservation of Oregon (in this section referred
to as the ``Warm Springs Tribe'') and dated April 23, 2003,
and such further agreements as are necessary between the
Secretary of Agriculture and the Warm Springs Tribe to carry
out the purposes of this section.
(b) Priority Use.--Members of Indian tribes with treaty-
reserved gathering rights on lands encompassed by Mount Hood
National Forest shall, in cooperation with the Mount Hood
National Forest, gather first foods in the priority-use areas
established pursuant to subsection (a).
(c) Applicable Law.--In considering and selecting National
Forest System land for inclusion in a priority-use area under
subsection (a), the Secretary of Agriculture shall comply
with the land and resource management plan for Mount Hood
National Forest and applicable laws.
(d) Definition.--In this section, the term ``first foods''
means roots, berries, and plants on National Forest System
land in Mount Hood National Forest that have been gathered
for traditional and cultural purposes by members of Indian
tribes with treaty-reserved gathering rights on lands
encompassed by Mount Hood National Forest.

SEC. 803. FOREST SERVICE COORDINATION WITH STATE AND LOCAL
GOVERNMENTS.

Congress encourages the Secretary of Agriculture to
cooperate with the State, local communities, counties, and
Indian tribes in the vicinity of Mount Hood National Forest,
and the heads of other Federal agencies to identify common
ground, coordinate planning efforts around the national
forest, and make the Federal Government a better partner in
building cooperative and lasting solutions for management of
Mount Hood National Forest and non-Federal land in the
vicinity of the national forest.

SEC. 804. SAVINGS PROVISIONS REGARDING RELATIONS WITH INDIAN
TRIBES.

(a) Treaty Rights.--Nothing in this Act is intended to
alter, modify, enlarge, diminish, or extinguish the treaty
rights of any Indian tribe, including the off-reservation
reserved rights established by the Treaty of June 25, 1855,
with the Tribes and Bands of Middle Oregon (12 Stat. 963).
Section 702 is consistent with and intended to implement the
gathering rights reserved by such treaty.
(b) Tribal Lands.--Nothing in this Act is intended to
affect lands held in trust by the Secretary of the Interior
for Indian tribes or individual members of Indian tribes or
other lands acquired by the Army Corps of Engineers and
administered by the Secretary of the Interior for the benefit
of Indian tribes and individual members of Indian tribes.
(c) Hunting and Fishing.--Nothing in this Act is intended
to affect the laws, rules, and regulations pertaining to
hunting and fishing under existing State and Federal laws and
Indian treaties.

SEC. 805. IMPROVED NATURAL DISASTER PREPAREDNESS.

(a) Imposition of Standards.--New development occurring on
land conveyed by the Secretary of Agriculture under title V
or undertaken or otherwise permitted by the Secretary of
Agriculture on National Forest System land in Mount Hood
National Forest after the date of the enactment of this Act
shall be constructed or altered in compliance with--
(1) 1 of--
(A) the nationally recognized model building codes; and
(B) nationally recognized wildland-urban interface codes
and standards; or
(2) 1 of the other applicable nationally recognized codes
and standards relating to--
(A) fire protection infrastructure in the wildland urban
interface;
(B) land development in wildland areas; or
(C) wild fire hazard mitigation.
(b) Inclusion of Standards in Land Conveyances.--In the
case of each of the land conveyances described in title V,
the Secretary shall impose the requirements of subsection (a)
as a condition on the conveyance of the Federal land under
the conveyance.
(c) Effect on State and Local Law.--To the maximum extent
feasible, the codes imposed pursuant to subsection (a) shall
be consistent with the nationally recognized codes and
development standards adopted or referenced by the State or
political subdivisions of the State. This section shall not
be construed to limit the power of the State or a political
subdivision of the State to implement or enforce any law,
rule, regulation, or standard concerning fire prevention and
control.
(d) Enforcement.--The codes imposed pursuant to subsection
(a) may be enforced by the same entities otherwise enforcing
codes, ordinances, and standards relating to new development
occurring on land conveyed by the Secretary of Agriculture
under title V.

TITLE IX--RECREATION

SEC. 901. FINDINGS AND PURPOSE.

The purpose of this title is to recognize and support
recreation as a dynamic social and economic component of the
legacy and future of the Mount Hood National Forest.

SEC. 902. RETENTION OF MOUNT HOOD NATIONAL FOREST LAND USE
FEES FROM SPECIAL USE AUTHORIZATIONS.

(a) Special Account.--The Secretary of the Treasury shall
establish a special account in the Treasury for Mount Hood
National Forest.
(b) Deposits.--Except as provided in section 7 of the Act
of April 24, 1950 (commonly known as the Granger-Thye Act; 16
U.S.C. 580d), the National Forest Organizational Camp Fee
Improvement Act of 2003 (title V of division F of Public Law
108-107; 16 U.S.C. 6231 et seq.), Public Law 106-206
(commonly known as the Commercial Filming Act; 16 U.S.C.
460l-d), and the Federal Lands Recreation Enhancement Act
(title VIII of division J of Public Law 108-477; 16 U.S.C.
6801 et seq.), all land use fees received after the date
which is 6 months after the date of enactment of this Act
from special use authorizations, such as recreation
residences, resorts, winter recreation resorts, communication
uses, and linear rights-of-way, and all other special use
types issued with regard to Mount Hood National Forest shall
be deposited in the special account established under
subsection (a).
(c) Availability.--Subject to subsection (d), amounts in
the special account established under subsection (a) shall
remain available, without further appropriation and until
expended, for expenditure as provided in section 903. Upon
request of the Secretary of Agriculture, the Secretary of the
Treasury shall transfer to the Secretary of Agriculture from
the special account such funds as the Secretary of
Agriculture may request. The Secretary shall accept and use
the funds in accordance with section 903.
(d) Termination of Special Account.--The special account
required by subsection (a) shall terminate at the end of the
10-year period beginning on the date of enactment of this
Act. Any amounts remaining in the special account at the end
of such period shall be transferred to the general fund of
the Treasury.

SEC. 903. USE OF FUNDS IN SPECIAL ACCOUNT TO SUPPORT
RECREATION.

(a) Authorized Uses.--The Secretary of Agriculture shall
use funds received from the special account under section
902(c) for the following purposes related to Mount Hood
National Forest:
(1) Installation, repair, maintenance, and facility
enhancement related directly to visitor enjoyment, visitor
access, and health and safety, such as--
(A) the improvement and maintenance of trails, including
trails used for hiking, biking, snowmobiling, horseback
riding, cross-country skiing, and off-highway vehicles;
(B) water system improvements; and
(C) personal sanitation facilities improvements.
(2) Interpretive programs, visitor information, visitor
services, visitor needs assessments, mapping, signage, Leave-
No-Trace materials, and wilderness rangers.
(3) Habitat restoration directly related to recreation.
(4) Cooperative environmental restoration projects with
non-Federal partnership groups and associations, including
groups and associations that work with youth.
(5) Law enforcement and rescue and recovery efforts related
to public use and recreation, such as law enforcement at
recreation events, search and rescue operations, illegal
recreation activities investigations, and enforcement.
(6) Improving administration of special use authorizations.
(7) Preparation of documents required under the National
Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) in
connection with the improvement or development of
recreational opportunities.
(8) Other projects or partnerships recommended by the Mount
Hood National Forest Recreation Working Group established by
section 905.
(b) Allocation Requirements.--Of the total funds received
by the Secretary of Agriculture from the special account
under section 902(c) for a fiscal year, the Secretary shall
allocate the funds as follows:
(1) 95 percent of the funds to Mount Hood National Forest.
(2) 5 percent of the funds to the Regional Office for the
Pacific Northwest Region of the Forest Service to develop
needed policy and training to support programs in wilderness
areas, special uses, trails, developed and dispersed
recreation, and interpretation related to Mount Hood National
Forest.

SEC. 904. ANNUAL REPORTING REQUIREMENT.

The Secretary of Agriculture shall submit to Congress an
annual report specifying--
(1) the total funds received by the Secretary from the
special account under section 902(c) for the preceding fiscal
year;
(2) how the funds were allocated and expended; and
(3) the results from such expenditures.

SEC. 905. MOUNT HOOD NATIONAL FOREST RECREATIONAL WORKING
GROUP.

(a) Establishment and Purpose.--The Secretary of
Agriculture shall establish the Mount Hood National Forest
Recreational Working Group for the purpose of providing
advice and recommendations to the Forest Service on planning
and implementing recreation enhancements in Mount Hood
National Forest, including advice and recommendations
regarding how the funds in the special

[[Page S2099]]

account established under section 902 should be requested and
expended.
(b) Duties.--The Working Group shall--
(1) review projects proposed by the Secretary for Mount
Hood National Forest under section 903(a);
(2) propose projects under section 903(a) to the Secretary;
(3) recommend the amount of funds from the special account
established under section 902 to be used to fund projects
under section 903; and
(4) provide opportunities for citizens, organizations,
Indian tribes, the Forest Service, and other interested
parties to participate openly and meaningfully, beginning at
the early stages of the development of projects under section
903(a).
(c) Appointment.--
(1) Appointment and term.--The Regional Forester, acting on
behalf of the Secretary of Agriculture, shall appoint the
members of the Working Group for a term of 3 years beginning
on the date of appointment. A member may be reappointed to
subsequent 3-year terms.
(2) Initial appointment.--The Regional Forester shall make
initial appointments to the Working Group not later than 180
days after the date of enactment of this Act.
(3) Vacancies.--The Regional Forester shall make
appointments to fill vacancies on the Working Group as soon
as practicable after the vacancy has occurred.
(4) Compensation.--Members of the Working Group shall not
receive any compensation for their service on the Working
Group.
(5) Nominations.--The State, county, and Tribal governments
for each county directly adjacent to or containing any
portion of Mount Hood National Forest may submit a nomination
to the Regional Forester for each activity or interest group
category described in subsection (d).
(6) Broad and balanced representation.--In appointing the
members of the Working Group, the Regional Forester shall
provide for a balanced and broad representation from the
recreation community.
(d) Composition of Working Group.--The Working Group shall
be composed of 15 members, selected so that the following
activities and interest groups are represented:
(1) Summer non-mechanized recreation, such as hiking.
(2) Winter non-motorized recreation, such as snowshoeing
and backcountry skiing.
(3) Mountain biking.
(4) Hunting and fishing.
(5) Summer motorized recreation, such as off-highway
vehicle use.
(6) Local environmental groups.
(7) Winter motorized recreation, such as snowmobiling.
(8) Permitted ski areas.
(9) Forest products industry.
(10) Affected Indian tribes.
(11) Local holder of a recreation residence permit.
(12) Local government interests, such as a county
commissioner or city mayor in an elected position
representing a county or city directly adjacent or containing
any portion of Mount Hood National Forest.
(13) A resident of Government Camp.
(14) The State.
(15) Operators of campground facilities open to the general
public.
(e) Chairperson.--The chairperson of the Working Group
shall be selected by a majority of the Working Group.
(f) Other Working Group Authorities and Requirements.--
(1) Staff assistance.--The Secretary of Agriculture shall
provide staff assistance to the Working Group from Federal
employees under the jurisdiction of the Secretary.
(2) Meetings.--All meetings of the Working Group shall be
announced at least 1 week in advance in a local newspaper of
record and shall be open to the public.
(3) Records.--The Working Group shall maintain records of
the meetings of the Working Group and make the records
available for public inspection.
(g) Limitation on Administrative Assistance.--Not more than
5 percent of the funds allocated under section 903(b) to
Mount Hood National Forest for a fiscal year may be used to
provide administrative assistance to the Working Group during
that fiscal year.
(h) Federal Advisory Committee Act.--The Federal Advisory
Committee Act (5 U.S.C. App.) shall not apply to the Working
Group.
(i) Termination of Working Group.--The Working Group shall
terminate at the end of the 10-year period beginning on the
date of enactment of this Act.

SEC. 906. CONSIDERATION OF CONVERSION OF FOREST ROADS TO
RECREATIONAL USES.

(a) Evaluation of Currently Closed Roads.--
(1) Consideration for recreational use.--The Secretary of
Agriculture may make a determination regarding whether the
Forest Service roads in Mount Hood National Forest that were
selected before the date of enactment of this Act for closure
and decommissioning, but have not yet been decommissioned,
should be converted to recreational uses to enhance
recreational opportunities in the national forest, such as
conversion to single-track trails for mountain bikes and
trails for snowmobiling, off-road vehicle use, horseback
riding, hiking, cross-country skiing, and other recreational
uses.
(2) Consideration of environmental and economic impacts.--
In evaluating the feasibility and suitability of converting
Forest Service roads under this subsection to recreational
uses, and the types of recreational uses to be authorized,
the Secretary shall take into account the environmental and
economic impacts of implementing the conversion and of the
resulting recreational uses.
(3) Public process.--The consideration and selection of
Forest Service roads under this subsection for conversion to
recreational uses, and the types of recreational uses to be
authorized, shall be a public process, including consultation
by the Secretary of Agriculture with the Mount Hood National
Forest Recreational Working Group.
(b) Future Closure Considerations.--Whenever the Secretary
of Agriculture considers a Forest Service road in Mount Hood
National Forest for possible closure and decommissioning
after the date of enactment of this Act, the Secretary shall
include, as an alternative to decommissioning the road,
consideration of converting the road to recreational uses to
enhance recreational opportunities in the Mount Hood National
Forest.

SEC. 907. IMPROVED TRAIL ACCESS FOR PERSONS WITH
DISABILITIES.

(a) Construction of Trail.--The Secretary of Agriculture
may enter into a contract with a partner organization or
other person to design and construct a trail at a location
selected by the Secretary in Mount Hood National Forest
suitable for use by persons with disabilities.
(b) Public Process.--The selection of the trail location
under subsection (a) and the preparation of the design of the
trail shall be a public process, including consultation by
the Secretary of Agriculture with the Mount Hood National
Forest Recreational Working Group.
(c) Funding.--The Secretary of Agriculture may use funds in
the special account established under section 902 to carry
out this section.

TITLE X--AUTHORIZATION OF APPROPRIATIONS

SEC. 1001. AUTHORIZATION OF APPROPRIATIONS.

There are authorized to be appropriated such sums as are
necessary to carry out this Act.
______

By Mr. REID:
S. 650. A bill to amend the Energy Employees Occupational Illness
Compensation Program Act of 2000 to provide for certain nuclear weapons
program workers to be included in the Special Exposure Cohort under the
compensation program established by that Act; to the Committee on
Health, Education, Labor and Pensions.
Mr. REID. 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. 650

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 ``Nevada Test Site Veterans'
Compensation Act of 2007''.

SEC. 2. FINDINGS.

Congress makes the following findings:
(1) The contribution of the State of Nevada to the security
of the United States throughout the Cold War and since has
been unparalleled.
(2) In 1950, President Harry S Truman designated what would
later be called the Nevada Test Site as the country's nuclear
proving grounds and, a month later, the first atmospheric
test at the Nevada Test Site was detonated.
(3) The United States conducted 100 above-ground and 828
underground nuclear tests at the Nevada Test Site from 1951
to 1992.
(4) Out of the 1,054 nuclear tests conducted in the United
States, 928, or 88 percent, were conducted at the Nevada Test
Site.
(5) The Nevada Test Site has served, and continues to
serve, as the premier research, testing, and development site
for the nuclear defense capabilities of the United States.
(6) The Nevada Test Site and its workers are an essential
and irreplaceable part of the Nation's defense capabilities.
(7) Individuals working on Cold War-era nuclear weapons
programs were employed in facilities owned by the Federal
Government and the private sector producing and testing
nuclear weapons and engaging in related atomic energy defense
activities for the national defense beginning in the 1940s.
(8) These Cold War atomic energy veterans helped to build
and test the nuclear arsenal that served as a deterrent
during the Cold War, sacrificing their personal health and
well-being in service to the United States.
(9) During the Cold War, many of these workers were exposed
to radiation, beryllium, and silica, and were placed in
harm's way by the Department of Energy and contractors,
subcontractors, and vendors of the Department without the
workers' knowledge or consent, without adequate radiation
monitoring, and without necessary protections from internal
or external occupational radiation exposure.
(10) The Energy Employees Occupational Illness Compensation
Program Act of 2000 (42 U.S.C. 7384 et seq.) (in this section
referred to as ``EEOICPA'') was enacted to ensure fairness
and equity for the men and women who, during the past 60
years, performed duties uniquely related to the nuclear
weapons

[[Page S2100]]

production and testing programs of the Department of Energy,
its predecessor agencies, and its contractors by establishing
a program that would provide timely, uniform, and adequate
compensation for beryllium- and radiation-related health
conditions.
(11) Research by the Department of Energy, the National
Institute for Occupational Safety and Health (NIOSH), NIOSH
contractors, the President's Advisory Board on Radiation and
Worker Health, and congressional committees indicates that at
certain nuclear weapons facilities--
(A) workers were not adequately monitored for internal or
external exposure to ionizing radiation; and
(B) records were not maintained, are not reliable, are
incomplete, or fail to indicate the radioactive isotopes to
which workers were exposed.
(12) Due to the inequities posed by the factors described
above and the resulting harm to the workers, Congress
designated classes of atomic weapons employees at the
Paducah, Kentucky, Portsmouth, Ohio, Oak Ridge K-25,
Tennessee, and the Amchitka Island, Alaska, sites as members
of the Special Exposure Cohort under EEOICPA.
(13) It has become evident that it is not feasible to
estimate with sufficient accuracy in a timely manner the
radiation dose received by employees at the Department of
Energy facility at the Nevada Test Site for many reasons,
including the following:
(A) The NIOSH Technical Basis Document, the threshold
document for radiation dose reconstruction under EEOICPA, has
incomplete radionuclide lists.
(B) NIOSH has not demonstrated that it can estimate dose
from exposure to large, nonrespirable hot particles.
(C) There are significant gaps in environmental measurement
and exposure data.
(D) Resuspension doses have been seriously underestimated.
(E) NIOSH has not been able to estimate accurately
exposures to bomb assembly workers and radon levels.
(F) NIOSH has not demonstrated that it can accurately
sample tritiated water vapor.
(G) External dose records lack integrity.
(H) There are no beta dose data from before 1966.
(I) There are no neutron dose data from before 1966 and
only partial data after such date.
(J) There are no internal dose data from before late 1955
or 1956, and limited data until well into the 1960s.
(K) NIOSH has ignored exposure from more than a dozen
underground tests that vented, including Blanca, Des Moines,
Baneberry, Camphor, Diagonal Line, Riola, Agrini, Midas Myth,
Misty Rain, and Mighty Oak.
(L) Instead of monitoring individuals, groups were
monitored, resulting in unreliable personnel monitoring.
(14) Some Nevada Test Site workers, despite having worked
with significant amounts of radioactive materials and having
known exposures leading to serious health effects, have been
denied compensation under EEOICPA as a result of flawed
calculations based on records that are incomplete or in
error, or based on faulty assumptions and incorrect models.
(15) Although basal cell carcinoma and chronic lymphocytic
leukemia are both radiogenic cancers that employees at the
Nevada Test Site may have contracted in the scope of their
work, EEOICPA currently will not include individuals with
basal cell carcinoma as members of the Special Exposure
Cohort, nor does it provide for compensation for employees
with chronic lymphocytic leukemia.

SEC. 3. INCLUSION OF CERTAIN NUCLEAR WEAPONS PROGRAM WORKERS
IN SPECIAL EXPOSURE COHORT UNDER ENERGY
EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION
PROGRAM.

(a) In General.--Section 3621 of the Energy Employees
Occupational Illness Compensation Program Act of 2000 (42
U.S.C. 7384l) is amended--
(1) in paragraph (9), by adding at the end the following
new subparagraph:
``(C) An individual described in paragraph (14)(D).''; and
(2) in paragraph (14), by adding at the end the following
new subparagraph:
``(D) The employee was so employed at the Nevada Test Site
or other similar sites located in Nevada during the period
beginning on January 1, 1950, and ending on December 31,
1993, and contracted an occupational illness, basal cell
carcinoma, or chronic lymphocytic leukemia, and, during such
employment--
``(i) was present during an atmospheric or underground
nuclear test or performed drillbacks, tunnel re-entry, or
clean-up work following such a test (without regard to the
duration of employment);
``(ii) was present at an event involving the venting of an
underground test or during a planned or unplanned radiation
release (without regard to the duration of employment);
``(iii) was present during testing or post-test activities
related to nuclear rocket or ramjet engine testing at the
Nevada Test Site (without regard to the duration of
employment);
``(iv) was assigned to work at Area 51 or other classified
program areas of the Nevada Test Site (without regard to the
duration of employment); or
``(v) was employed at the Nevada Test Site, and was
employed in a job activity that--

``(I) was monitored for exposure to ionizing radiation; or
``(II) was comparable to a job that is, was, or should have
been monitored for exposure to ionizing radiation at the
Nevada Test Site.''.

(b) Deadline for Claims Adjudication.--Claims for
compensation under section 3621(14)(D) of the Energy
Employees Occupational Illness Compensation Program Act of
2000, as added by subsection (a), shall be adjudicated and a
final decision issued--
(1) in the case of claims pending as of the date of the
enactment of this Act, not later than 30 days after such
date; and
(2) in the case of claims filed after the date of the
enactment of this Act, not later than 30 days after the date
of such filing.
______

By Mr. HARKIN (for himself and Mrs. Clinton):
S. 651. A bill to help promote the national recommendation of
physical activity to kids, families, and communities across the United
States; to the Committee on Health, Education, Labor, and Pensions.
Mr. HARKIN. Mr. President, as you may have heard, today we are
launching the Partnership for Play Every Day and it has been
spearheaded by three terrific organizations: the YMCA, the National
Recreation and Park Association, and the National Association for Sport
and Physical Education. Together, they have 350 years of experience in
helping our kids to be physically active or, to use the old-fashioned
word, ``to play.''
More than a century ago, these groups came together to support the
Playground Movement, which took kids out of factories and coal mines,
and gave them parks and playgrounds where they could be children again.
Well, today we face a different challenge. As we confront an epidemic
of childhood obesity, as many new elementary schools are built without
playgrounds, as recess and PE are phased out of so many of our schools,
we need a 21st century Playground Movement. And that's what we are
launching this morning.
On a personal note, I have been a lifelong admirer of the YMCA. When
I was in my early 20s and aspiring to join the Navy as a fighter pilot,
they told me: First you've got to learn how to swim. So what did I do?
I signed up at the Y in downtown Des Moines for swimming lessons.
Well, the Y was there for me, just as the Y is there for millions of
American families, giving them the facilities and tools to stay fit and
healthy.
You know, there is something fundamentally wrong when kids spend
their free time parked in front of the TV instead of playing in parks.
I mentioned the childhood obesity epidemic. ``Epidemic'' is not my
word. That's what the Centers for Disease Control and Prevention call
it. Today, nearly 15 percent of American children and teenagers are
obese. A quarter of the children between the ages of 5 and 10 already
show the early warning signs of heart disease. Cases of adult-onset
diabetes in children--which used to be almost unheard of--have exploded
tenfold in the last two decades.
Add it all up, and experts say there is a very real prospect that
today's kids could be the first generation in American history to have
a shorter lifespan than their parent's generation.
And that is unacceptable. We are not going to let that happen. And
that is why we have set the goal of ensuring that every child in
America gets 60 minutes of play and physical activity every day.
Hand in hand with this important new initiative, today I am honored
to introduce with Senator Hillary Clinton a bill called the PLAY Every
Day Act. That first word, PLAY, is an acronym for ``Promoting Lifelong
Active Communities.''
The PLAY Every Day Act will help to promote the national physical-
activity standards for both children and adults.
To that end, the legislation will do two things:
One, it will mandate the development of a well-validated assessment
tool called the ``community play index,'' to identify barriers
preventing young people from being physically active in a given
community.
And two, it will help local coalitions to use this ``community play
index'' as they craft plans to promote physical activity and wellness
in their communities.
My vision is to have every community in America focused on promoting

[[Page S2101]]

health and preventing disease--instead of just dealing with the bad
consequences of obesity, diabetes, and heart disease.
By the way, I am grateful to the good corporate citizens that are
joining in the Partnership for Play Every Day, including PepsiCo,
Toyota, Kellogg Company, General Mills, PlayCore, and Landscape
Structures. Your support of this legislation and new initiative is
going to be critical to the Partnership's success.
So, again, I salute all the players in this new Partnership.
Together, we can build a better, healthier future for America's
children.
______

By Mr. DURBIN (for himself and Mr. Schumer):
S. 654. A bill to establish the Food Safety Administration to protect
the public health by preventing food-borne illness, ensuring the safety
of food, improving research on contaminants leading to food-borne
illness, and improving security of food from intentional contamination,
and for other purposes; to the Committee on Agriculture, Nutrition, and
Forestry.
Mr. DURBIN. Mr. President, years ago, a friend from Chicago went out
and bought hamburger meat at a local grocery store. She took it home,
cooked it, and gave it to her five-year-old boy. That poor boy was
exposed to E. coli and died a few days later, a gruesome, horrible
death.
In 1992, four children died and 700 people were sickened by an E.
coli outbreak that was traced to hamburgers served at Jack in the Box
restaurants. That outbreak proved to be a pivotal moment in the history
of the beef industry. The Federal Government revamped the meat
inspection program which has led a decline in the number of illnesses
from beef since 2000.
The E. coli outbreaks from fresh produce that occurred at the end of
2006 may prove to be the critical events for the produce industry as
the Jack in the Box outbreak was for the meat industry. Three people
died and nearly 200 were sickened in 26 States due to E. coli that was
traced back to packaged spinach.
The breadth of the problem of foodborne illness is stunning. The
Centers for Disease Control and Prevention estimate that as many as 76
million people suffer from food poisoning each year. Of those
individuals, approximately 325,000 will be hospitalized and more than
5,000 will die. Children and the elderly are especially vulnerable to
foodborne pathogens. Despite these statistics, our food supply is still
the safest in the world; however, there are widening gaps in our food
safety system due to the fact that food safety oversight has evolved
over time and is spread across several agencies.
As the number of foods imported from outside the United States
continues to increase so do concerns that terrorists could easily
attack our food supply and distribute a harmful product widely. It is
more important now then ever to reinforce any potential weak spots in
our food safety system.
Last month, the Government Accountability Office (GAO) designated the
Federal oversight of food safety as a high-risk area. In order to
achieve greater effectiveness and accountability, there needs to be a
broad-based transformation of our federal food safety oversight. GAO
concluded that the fragmented federal system, with 15 agencies
collectively administering at least 30 laws, has caused inconsistent
oversight and an inefficient use of resources. An accidental or
deliberate contamination of the food supply could undermine consumer
confidence and cause severe economic consequences. It is not a surprise
that GAO placed food safety oversight on its high-risk list this year.
GAO has been calling for a single food safety agency for the past 30
years.
Here is one example of where our current food safety system doesn't
make sense. Take a pre-packaged ham and cheese sandwich that's
available at your local convenience store. The way the sandwich is
regulated depends on how it is presented. USDA has jurisdiction if the
sandwich is a packaged open-face meat or poultry sandwich that contains
one slice of bread. If the sandwich is a closed-face meat or poultry
sandwich, meaning it has two slices of bread, FDA inspects it. USDA
inspects the open-face sandwiches that are sold in interstate commerce
on a daily basis while FDA inspects closed-face sandwiches an average
of once every five years.
Here's another example that illustrates the inefficient use of
resources. The U.S. Department of Agriculture (USDA) and the Food and
Drug Administration (FDA) both inspect shipments of imported food at 18
U.S. ports-of-entry; however the two agencies do not share inspection
resources at these ports. USDA import inspectors are assigned to USDA-
approved import inspection facilities at these ports and some of the
ports also handle FDA-regulated products. USDA does not have
jurisdiction over the FDA-regulated products. USDA has inspectors
assigned to these facilities every day while the FDA-regulated products
may remain at the facilities for some time awaiting FDA inspection. In
fiscal year 2003, USDA spent nearly $16 million on imported food
inspections and FDA spent over $115 million. This is just one example
of where millions of dollars could have been saved if one agency
oversaw the inspection process.
Please join me in sponsoring the Safe Food Act of 2007, which
addresses our Nation's fractured food safety system. The Safe Food Act
of 2007 would create a single, independent Federal food safety agency
to administer all aspects of Federal food safety efforts, including
inspections, enforcement, standards-setting and research, in order to
protect public health. The agencies and sub-agencies now charged with
protecting the food supply, primarily housed at the Food and Drug
Administration and the Department of Agriculture, would be transferred
to this new agency.
A single food safety agency with authority based on sound scientific
principles would provide this country with the greatest hope of
reducing foodborne illness, and would also prevent or minimize the harm
of a bioterrorist attack on our food supply. The Safe Food Act of 2007
would put authority for imported and domestic food in the hands of one
Food Safety Administrator. The Administrator would oversee one science-
based food safety law that would harmonize the various authorities that
currently govern food safety regulation.
Our food distribution system has undergone many changes over the
years. For example, in the past, it was likely that produce that ended
up in a local grocery store came from a farm not too far from the
retailer. Fast forward to today produce grown on a single farm in one
state could end up on dinner tables in many states across the country.
We cannot continue trying to use a 1950s food safety model to oversee a
21st Century food distribution system. That's like asking a propeller
plane to keep up with an F-18. We need to change, to shed the old
bureaucratic shackles that have tied us to the overlapping and
inefficient ad hoc food safety system of the past and create a system
fit for the 21st Century.
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. 654

Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title.--This Act may be cited as the ``Safe Food
Act of 2007''.
(b) Table of Contents.--The table of contents of this Act
is as follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings; purposes.
Sec. 3. Definitions.

TITLE I--ESTABLISHMENT OF FOOD SAFETY ADMINISTRATION

Sec. 101. Establishment of Food Safety Administration.
Sec. 102. Consolidation of separate food safety and inspection services
and agencies.
Sec. 103. Additional duties of the Administration.

TITLE II--ADMINISTRATION OF FOOD SAFETY PROGRAM

Sec. 201. Administration of national program.
Sec. 202. Registration of food establishments and foreign food
establishments.
Sec. 203. Preventative process controls to reduce adulteration of food.
Sec. 204. Performance standards for contaminants in food.
Sec. 205. Inspections of food establishments.
Sec. 206. Food production facilities.
Sec. 207. Federal and State cooperation.

[[Page S2102]]

Sec. 208. Imports.
Sec. 209. Resource plan.
Sec. 210. Traceback.

TITLE III--RESEARCH AND EDUCATION

Sec. 301. Public health assessment system.
Sec. 302. Public education and advisory system.
Sec. 303. Research.

TITLE IV--ENFORCEMENT

Sec. 401. Prohibited Acts.
Sec. 402. Food detention, seizure, and condemnation.
Sec. 403. Notification and recall.
Sec. 404. Injunction proceedings.
Sec. 405. Civil and criminal penalties.
Sec. 406. Presumption.
Sec. 407. Whistleblower protection.
Sec. 408. Administration and enforcement.
Sec. 409. Citizen civil actions.

TITLE V--IMPLEMENTATION

Sec. 501. Definition.
Sec. 502. Reorganization plan.
Sec. 503. Transitional authorities.
Sec. 504. Savings provisions.
Sec. 505. Conforming amendments.
Sec. 506. Additional technical and conforming amendments.
Sec. 507. Regulations.
Sec. 508. Authorization of appropriations.
Sec. 509. Limitation on authorization of appropriations.
Sec. 510. Effective date.

SEC. 2. FINDINGS; PURPOSES.

(a) Findings.--Congress finds that--
(1) the safety of the food supply of the United States is
vital to the public health, to public confidence in the food
supply, and to the success of the food sector of the Nation's
economy;
(2) lapses in the protection of the food supply and loss of
public confidence in food safety are damaging to consumers
and the food industry, and place a burden on interstate
commerce;
(3) the safety and security of the food supply requires an
integrated, system-wide approach to preventing food-borne
illness, a thorough and broad-based approach to basic and
applied research, and intensive, effective, and efficient
management of the Nation's food safety program;
(4) the task of preserving the safety of the food supply of
the United States faces tremendous pressures with regard to--
(A) emerging pathogens and other contaminants and the
ability to detect all forms of contamination;
(B) an aging and immune compromised population, with a
growing number of people at high-risk for food-borne
illnesses, including infants and children;
(C) an increasing volume of imported food, without adequate
monitoring and inspection; and
(D) maintenance of rigorous inspection of the domestic food
processing and food service industries;
(5) Federal food safety standard setting, inspection,
enforcement, and research efforts should be based on the best
available science and public health considerations and food
safety resources should be systematically deployed in ways
that most effectively prevent food-borne illness;
(6) the Federal food safety system is fragmented, with at
least 12 Federal agencies sharing responsibility for food
safety, and operates under laws that do not reflect current
conditions in the food system or current scientific knowledge
about the cause and prevention of food-borne illness;
(7) the fragmented Federal food safety system and outdated
laws preclude an integrated, system-wide approach to
preventing food-borne illness, to the effective and efficient
operation of the Nation's food safety program, and to the
most beneficial deployment of food safety resources;
(8) the National Academy of Sciences recommended in the
report ``Ensuring Safe Food from Production to Consumption''
that Congress establish by statute a unified and central
framework for managing Federal food safety programs, and
recommended modifying Federal statutes so that inspection,
enforcement, and research efforts are based on scientifically
supportable assessments of risks to public health; and
(9) the lack of a single focal point for food safety
leadership in the United States undercuts the ability of the
United States to exert food safety leadership
internationally, which is detrimental to the public health
and the international trade interests of the United States.
(b) Purposes.--The purposes of this Act are--
(1) to establish a single agency to be known as the ``Food
Safety Administration'' to--
(A) regulate food safety and labeling to strengthen the
protection of the public health;
(B) ensure that food establishments fulfill their
responsibility to produce food in a manner that protects the
public health of all people in the United States;
(C) lead an integrated, system-wide approach to food safety
and to make more effective and efficient use of resources to
prevent food-borne illness;
(D) provide a single focal point for food safety
leadership, both nationally and internationally; and
(E) provide an integrated food safety research capability,
utilizing internally-generated, scientifically and
statistically valid studies, in cooperation with academic
institutions and other scientific entities of the Federal and
State governments, to achieve the continuous improvement of
research on food-borne illness and contaminants;
(2) to transfer to the Food Safety Administration the food
safety, labeling, inspection, and enforcement functions that,
as of the day before the effective date of this Act, are
performed by other Federal agencies; and
(3) to modernize and strengthen the Federal food safety
laws to achieve more effective application and efficient
management of the laws for the protection and improvement of
public health.

SEC. 3. DEFINITIONS.

In this Act:
(1) Administration.--The term ``Administration'' means the
Food Safety Administration established under section
101(a)(1).
(2) Administrator.--The term ``Administrator'' means the
Administrator of Food Safety appointed under section
101(a)(3).
(3) Adulterated.--
(A) In general.--The term ``adulterated'' has the meaning
described in subsections (a) through (c) of section 402 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342).
(B) Inclusion.--The term ``adulterated'' includes bearing
or containing a contaminant that causes illness or death
among sensitive populations.
(4) Agency.--The term ``agency'' has the meaning given that
term in section 551 of title 5, United States Code.
(5) Category 1 food establishment.--The term ``category 1
food establishment'' means a food establishment that
slaughters animals for food.
(6) Category 2 food establishment.--The term ``category 2
food establishment'' means a food establishment that
processes raw meat, poultry, seafood products, regardless of
whether the establishment also has a kill step, and animal
feed and other products that the Administrator determines by
regulation to be at high risk of contamination and the
processes of which do not include a step validated to destroy
contaminants.
(7) Category 3 food establishment.--The term ``category 3
food establishment'' means a food establishment that
processes meat, poultry, seafood products, and other products
that the Administrator determines by regulation to be at high
risk of contamination and whose processes include a step
validated to destroy contaminants.
(8) Category 4 food establishment.--The term ``category 4
food establishment'' means a food establishment that
processes all other categories of food products not described
in paragraphs (5) through (7).
(9) Category 5 food establishment.--The term ``category 5
food establishment'' means a food establishment that stores,
holds, or transports food products prior to delivery for
retail sale.
(10) Contaminant.--The term ``contaminant'' includes a
bacterium, chemical, natural or manufactured toxin, virus,
parasite, prion, physical hazard, or other human pathogen
that when found on or in food can cause human illness,
injury, or death.
(11) Contamination.--The term ``contamination'' refers to a
presence of a contaminant in food.
(12) Food.--
(A) In general.--The term ``food'' means a product intended
to be used for food or drink for a human or an animal.
(B) Inclusions.--The term ``food'' includes any product
(including a meat food product, as defined in section 1(j) of
the Federal Meat Inspection Act (21 U.S.C. 601(j))), capable
for use as human food that is made in whole or in part from
any animal, including cattle, sheep, swine, or goat, or
poultry (as defined in section 4 of the Poultry Products
Inspection Act (21 U.S.C. 453)), and animal feed.
(C) Exclusion.--The term ``food'' does not include dietary
supplements, as defined in section 201(ff) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)).
(13) Food establishment.--
(A) In general.--The term ``food establishment'' means a
slaughterhouse, factory, warehouse, or facility owned or
operated by a person located in any State that processes food
or a facility that holds, stores, or transports food or food
ingredients.
(B) Exclusions.--For the purposes of registration, the term
``food establishment'' does not include a farm, restaurant,
other retail food establishment, nonprofit food establishment
in which food is prepared for or served directly to the
consumer, or fishing vessel (other than a fishing vessel
engaged in processing, as that term is defined in section
123.3 of title 21, Code of Federal Regulations).
(14) Food production facility.--The term ``food production
facility'' means any farm, ranch, orchard, vineyard,
aquaculture facility, or confined animal-feeding operation.
(15) Food safety law.--The term ``food safety law'' means--
(A) the provisions of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.) related to and requiring the
safety, labeling, and inspection of food, infant formulas,
food additives, pesticide residues, and other substances
present in food under that Act;
(B) the provisions of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.) and of any other Act that are
administered by the Center for Veterinary Medicine of the
Food and Drug Administration;
(C) the Poultry Products Inspection Act (21 U.S.C. 451 et
seq.);
(D) the Federal Meat Inspection Act (21 U.S.C. 601 et
seq.);
(E) the Egg Products Inspection Act (21 U.S.C. 1031 et
seq.);
(F) the Sanitary Food Transportation Act of 1990 (49 U.S.C.
App. 2801 et seq.);

[[Page S2103]]

(G) the amendments made by the Sanitary Food Transportation
Act of 2005 (subtitle B of title VII of the Safe,
Accountable, Flexible, Efficient Transportation Equity Act: A
Legacy for Users) (21 U.S.C. 301 note);
(H) the provisions of the Humane Methods of Slaughter Act
of 1978 (21 U.S.C. 601 note) administered by the Food Safety
and Inspection Service;
(I) the provisions of this Act; and
(J) such other provisions of law related to and requiring
food safety, labeling, inspection, and enforcement as the
President designates by Executive order as appropriate to
include within the jurisdiction of the Administration.
(16) Foreign food establishment.--The term ``foreign food
establishment'' means a slaughterhouse, factory, warehouse,
or facility located outside the United States that processes
food for consumption that is imported into the United States
or food ingredients.
(17) Interstate commerce.--The term ``interstate commerce''
has the meaning given that term in section 201(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(b)).
(18) Misbranded.--The term ``misbranded'' has the meaning
given that term in section 403 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 343).
(19) Process.--The term ``process'' or ``processing'' means
the commercial harvesting, slaughter, packing, preparation,
or manufacture of food.
(20) Safe.--The term ``safe'' refers to human and animal
health.
(21) State.--The term ``State'' means--
(A) a State;
(B) the District of Columbia;
(C) the Commonwealth of Puerto Rico; and
(D) any other territory or possession of the United States.
(22) Validation.--The term ``validation'' means the
obtaining of evidence that the food hygiene control measure
or measures selected to control a hazard in food is capable
of effectively and consistently controlling the hazard.
(23) Statistically valid.--With respect to a study, the
term ``statistically valid'' means evaluated and conducted
under standards set by the National Institute of Standards
and Technology.

TITLE I--ESTABLISHMENT OF FOOD SAFETY ADMINISTRATION

SEC. 101. ESTABLISHMENT OF FOOD SAFETY ADMINISTRATION.

(a) Establishment.--
(1) In general.--There is established in the executive
branch an agency to be known as the ``Food Safety
Administration''.
(2) Status.--The Administration shall be an independent
establishment (as defined in section 104 of title 5, United
States Code).
(3) Head of administration.--The Administration shall be
headed by the Administrator of Food Safety, who shall be
appointed by the President, by and with the advice and
consent of the Senate.
(b) Duties of Administrator.--The Administrator shall--
(1) administer and enforce the food safety law;
(2) serve as a representative to international food safety
bodies and discussions;
(3) promulgate regulations to ensure the security of the
food supply from all forms of contamination, including
intentional contamination; and
(4) oversee--
(A) implementation of Federal food safety inspection,
enforcement, and research efforts, to protect the public
health;
(B) development of consistent and science-based standards
for safe food;
(C) coordination and prioritization of food safety research
and education programs with other Federal agencies;
(D) prioritization of Federal food safety efforts and
deployment of Federal food safety resources to achieve the
greatest possible benefit in reducing food-borne illness;
(E) coordination of the Federal response to food-borne
illness outbreaks with other Federal and State agencies; and
(F) integration of Federal food safety activities with
State and local agencies.

SEC. 102. CONSOLIDATION OF SEPARATE FOOD SAFETY AND
INSPECTION SERVICES AND AGENCIES.

(a) Transfer of Functions.--For each Federal agency
specified in subsection (b), there are transferred to the
Administration all functions that the head of the Federal
agency exercised on the day before the effective date of this
Act (including all related functions of any officer or
employee of the Federal agency) that relate to administration
or enforcement of the food safety law, as determined by the
President.
(b) Transferred Agencies.--The Federal agencies referred to
in subsection (a) are--
(1) the Food Safety and Inspection Service of the
Department of Agriculture;
(2) the Center for Food Safety and Applied Nutrition of the
Food and Drug Administration;
(3) the part of the Agriculture Marketing Service that
administers shell egg surveillance services established under
the Egg Products Inspection Act (21 U.S.C. 1031 et seq.);
(4) the resources and facilities of the Office of
Regulatory Affairs of the Food and Drug Administration that
administer and conduct inspections of food establishments and
imports;
(5) the resources and facilities of the Office of the
Commissioner of the Food and Drug Administration that
support--
(A) the Center for Food Safety and Applied Nutrition;
(B) the Center for Veterinary Medicine; and
(C) the Office of Regulatory Affairs facilities and
resources described in paragraph (4);
(6) the Center for Veterinary Medicine of the Food and Drug
Administration;
(7) the resources and facilities of the Environmental
Protection Agency that control and regulate pesticide
residues in food;
(8) the part of the Research, Education, and Economics
mission area of the Department of Agriculture related to food
safety and animal feed research;
(9) the part of the National Marine Fisheries Service of
the National Oceanic and Atmospheric Administration of the
Department of Commerce that administers the seafood
inspection program;
(10) the Animal and Plant Inspection Health Service of the
Department of Agriculture; and
(11) such other offices, services, or agencies as the
President designates by Executive order to carry out this
Act.

SEC. 103. ADDITIONAL DUTIES OF THE ADMINISTRATION.

(a) Officers and Employees.--The Administrator may--
(1) appoint officers and employees for the Administration
in accordance with the provisions of title 5, United States
Code, relating to appointment in the competitive service; and
(2) fix the compensation of those officers and employees in
accordance with chapter 51 and with subchapter III of chapter
53 of that title, relating to classification and General
Schedule pay rates.
(b) Experts and Consultants.--The Administrator may--
(1) procure the services of temporary or intermittent
experts and consultants as authorized by section 3109 of
title 5, United States Code; and
(2) pay in connection with those services the travel
expenses of the experts and consultants, including
transportation and per diem in lieu of subsistence while away
from the homes or regular places of business of the
individuals, as authorized by section 5703 of that title.
(c) Bureaus, Offices, and Divisions.--The Administrator may
establish within the Administration such bureaus, offices,
and divisions as the Administrator determines are necessary
to perform the duties of the Administrator.
(d) Advisory Committees.--
(1) In general.--The Administrator shall establish advisory
committees that consist of representatives of scientific
expert bodies, academics, industry specialists, and
consumers.
(2) Duties.--The duties of an advisory committee
established under paragraph (1) may include developing
recommendations with respect to the development of new
processes, research, communications, performance standards,
and inspection.

TITLE II--ADMINISTRATION OF FOOD SAFETY PROGRAM

SEC. 201. ADMINISTRATION OF NATIONAL PROGRAM.

(a) In General.--The Administrator shall--
(1) administer a national food safety program (referred to
in this section as the ``program'') to protect public health;
and
(2) ensure that persons who produce or process food meet
their responsibility to prevent or minimize food safety
hazards related to their products.
(b) Comprehensive Analysis.--The program shall be based on
a comprehensive analysis of the hazards associated with
different food and with the processing of different food,
including the identification and evaluation of--
(1) the severity of the potential health risks;
(2) the sources and specific points of potential
contamination extending from the farm or ranch to the
consumer that may render food unsafe;
(3) the potential for persistence, multiplication, or
concentration of naturally occurring or added contaminants in
food;
(4) opportunities across the food production, processing,
distribution, and retail system to reduce potential health
risks; and
(5) opportunities for intentional contamination.
(c) Program Elements.--In carrying out the program, the
Administrator shall--
(1) adopt and implement a national system for the
registration of food establishments and foreign food
establishments and regular unannounced inspection of food
establishments;
(2) enforce the adoption of process controls in food
establishments, based on best available scientific and public
health considerations and best available technologies;
(3) establish and enforce science-based standards for--
(A) substances that may contaminate food; and
(B) safety and sanitation in the processing and handling of
food;
(4) implement a statistically valid sampling program to
ensure that industry programs and procedures that prevent
food contamination are effective on an ongoing basis and that
food meets the standards established under this Act;
(5) implement procedures and requirements to ensure the
safety and security of imported food;

[[Page S2104]]

(6) coordinate with other agencies and State or local
governments in carrying out inspection, enforcement,
research, and monitoring;
(7) have access to the surveillance data of the Centers for
Disease Control and Prevention, and other Federal Government
agencies, in order to implement a national surveillance
system to assess the health risks associated with the human
consumption of food or to create surveillance data and
studies;
(8) develop public education risk communication and
advisory programs;
(9) implement a basic and applied research program to
further the purposes of this Act; and
(10) coordinate and prioritize food safety research and
educational programs with other agencies, including State or
local agencies.

SEC. 202. REGISTRATION OF FOOD ESTABLISHMENTS AND FOREIGN
FOOD ESTABLISHMENTS.

(a) In General.--The Administrator shall by regulation
require that any food establishment or foreign food
establishment engaged in processing food in the United States
be registered with the Administrator.
(b) Registration Requirements.--
(1) In general.--To be registered under subsection (a)--
(A) in the case of a food establishment, the owner,
operator, or agent in charge of the food establishment shall
submit a registration to the Administrator; and
(B) in the case of a foreign food establishment, the owner,
operator, or agent in charge of the foreign food
establishment shall--
(i) submit a registration to the Administrator; and
(ii) provide the name, address, and emergency contact
information of the United States agent for the foreign food
establishment.
(2) Registration.--A food establishment or foreign food
establishment shall submit a registration under paragraph (1)
to the Administrator that--
(A) identifies the name, address, and emergency contact
information of each food establishment or foreign food
establishment that the registrant operates under this Act and
all trade names under which the registrant conducts business
relating to food;
(B) lists the primary purpose and business activity of each
food establishment or foreign food establishment, including
the dates of operation if the food establishment or foreign
food establishment is seasonal;
(C) lists the types of food processed or sold at each food
establishment or, for foreign food establishments selling
food for consumption in the United States, identifies the
specific food categories of that food as listed under section
170.3 of title 21, Code of Federal Regulations; and
(D) not later than 30 days after a change in the products,
function, or legal status of the food establishment or
foreign food establishment (including cessation of business
activities), notifies the Administrator of the change.
(3) Procedure.--Upon receipt of a completed registration
described in paragraph (1), the Administrator shall notify
the registrant of the receipt of the registration, designate
each establishment as a category 1, 2, 3, 4, or 5 food
establishment, and assign a registration number to each food
establishment and foreign food establishment.
(4) List.--The Administrator shall compile and maintain an
up-to-date list of food establishments and foreign food
establishments that are registered under this section. The
Administrator may establish regulations by which such list
may be shared with other governmental authorities.
(5) Disclosure exemption.--The disclosure requirements
under section 552 of title 5, United States Code, shall not
apply to--
(A) the list compiled under paragraph (4); and
(B) information derived from the list under paragraph (4),
to the extent that it discloses the identity or location of a
specific registered person.
(6) Suspension of registration.--
(A) In general.--The Administrator may suspend the
registration of a food establishment or foreign food
establishment, including the facility of an importer, for
violation of a food safety law.
(B) Notice and opportunity for hearing.--The Administrator
shall provide notice to a registrant immediately upon the
suspension of the registration of the facility and provide
registrant with an opportunity for a hearing within 3 days of
the suspension.
(7) Reinstatement.--A registration that is suspended under
this section may be reinstated pursuant to criteria published
in the Federal Register by the Administrator.

SEC. 203. PREVENTATIVE PROCESS CONTROLS TO REDUCE
ADULTERATION OF FOOD.

(a) In General.--The Administrator shall, upon the basis of
best available public health, scientific, and technological
data, promulgate regulations to ensure that food
establishments carry out their responsibilities to--
(1) process food in a sanitary manner so that it is free of
dirt and filth;
(2) limit the presence of potentially harmful contaminants
in food;
(3) implement appropriate measures of preventative process
control to minimize and reduce the presence and growth of
contaminants in food and meet the performance standards
established under section 204;
(4) process all fully processed or ready-to-eat food in a
sanitary manner, using reasonably available techniques and
technologies to eliminate any potentially harmful
contaminants; and
(5) label food intended for final processing outside
commercial food establishments with instructions for handling
and preparation for consumption that will destroy
contaminants.
(b) Regulations.--Not later than 1 year after the effective
date of this Act, the Administrator shall promulgate
regulations that--
(1) require all food establishments to adopt preventative
process controls that are--
(A) adequate to protect the public health;
(B) meet relevant regulatory and food safety standards; and
(C) limit the presence and growth of contaminants in food
prepared in a food establishment;
(2) set standards for sanitation;
(3) meet any performance standards for contaminants
established under section 204;
(4) require recordkeeping to monitor compliance;
(5) require sampling and testing at a frequency and in a
manner sufficient to ensure that process controls are
effective on an ongoing basis and that regulatory standards
are being met; and
(6) provide for agency access to records kept by food
establishments and submission of copies of the records to the
Administrator, as the Administrator determines appropriate.
(c) Processing Controls.--The Administrator may require any
person with responsibility for or control over food or food
ingredients to adopt process controls, if the process
controls are needed to ensure the protection of the public
health.

SEC. 204. PERFORMANCE STANDARDS FOR CONTAMINANTS IN FOOD.

(a) In General.--To protect the public health, the
Administrator shall establish by regulation and enforce
performance standards that define, with respect to specific
food-borne contaminants and foods, the level of food safety
performance that a person responsible for producing,
processing, or selling food shall meet.
(b) Identification of Contaminants; Performance
Standards.--
(1) In general.--Not later than 6 months after the date of
enactment of this Act, the Administrator shall identify the
food-borne contaminants and food that contribute
significantly to the risk of food-borne illness.
(2) Performance standards.--As soon as practicable after
the identification of the contaminants under paragraph (1),
the Administrator shall establish appropriate performance
standards to protect against all food-borne contaminants.
(3) Significant contaminants.--The Administrator shall
establish performance standards for the 5 contaminants that
contribute to the greatest number of illnesses or deaths
associated with raw meat, poultry, and seafood not later than
3 years after the date of enactment of this Act. The
Administrator shall revise such standards not less often than
every 3 years.
(c) Performance Standards.--
(1) In general.--The performance standards established
under this section shall include--
(A) health-based standards that set the level of a
contaminant that can safely and lawfully be present in food;
(B) zero tolerances, including zero tolerances for fecal
matter, in addition to any zero-tolerance standards in effect
on the day before the date of enactment of this Act, when
necessary to protect against significant adverse health
outcomes;
(C) process standards, such as log reduction criteria for
cooked products, when sufficient to ensure the safety of
processed food; and
(D) in the absence of data to support a performance
standard described in subparagraph (A), (B), or (C),
standards that define required performance in terms of ``best
reasonably achievable performance'', using best available
technologies, interventions, and practices.
(2) Best reasonably achievable performance standards.--In
developing best reasonably achievable performance standards,
the Administrator shall collect, or contract for the
collection of, data on current best practices and food safety
outcomes related to the contaminants and foods in question,
as the Administrator determines necessary.
(3) Revocation by administrator.--All performance
standards, tolerances, action levels, or other similar
standards in effect on the date of enactment of this Act
shall remain in effect until revised or revoked by the
Administrator.
(d) Enforcement.--
(1) In general.--Not later than 1 year after the
promulgation of a performance standard under this section,
the Administrator shall implement a statistically significant
sampling program to determine whether food establishments are
complying with the performance standards promulgated under
this section. The program established under this paragraph
shall be at least as stringent as the Hazard Analysis and
Critical Control Point System requirements established under
part 417 of title 9, Code of Federal Regulations (or
successor regulation).
(2) Inspections.--If the Administrator determines that a
food establishment fails to meet a standard promulgated under
this section, and such establishment fails to take

[[Page S2105]]

appropriate corrective action as determined by the
Administrator, the Administrator shall, as appropriate--
(A) detain, seize, or condemn food from the food
establishment under section 402;
(B) order a recall of food from the food establishment
under section 403;
(C) increase the inspection frequency for the food
establishment;
(D) withdraw the mark of inspection from the food
establishment, if in use; or
(E) take other appropriate enforcement action concerning
the food establishment, including withdrawal of registration.
(e) Newly Identified Contaminants.--Notwithstanding any
other provision of this section, the Administrator shall
promulgate interim performance standards for newly identified
contaminants as necessary to protect the public health.

SEC. 205. INSPECTIONS OF FOOD ESTABLISHMENTS.

(a) In General.--The Administrator shall establish an
inspection program, which shall include sampling and testing
of food and food establishments, to determine if each food
establishment--
(1) is operating in a sanitary manner;
(2) has continuous systems, interventions, and processes in
place to minimize or eliminate contaminants in food;
(3) is in compliance with applicable performance standards
established under section 204, and other regulatory
requirements;
(4) is processing food that is safe and not adulterated or
misbranded;
(5) maintains records of process control plans under
section 203, and other records related to the processing,
sampling, and handling of food; and
(6) is in compliance with the requirements of the food
safety law.
(b) Establishment Categories and Inspection Frequencies.--
The resource plan required under section 209, including the
description of resources required to carry out inspections of
food establishments, shall be based on the following
categories and inspection frequencies, subject to subsections
(c), (d), and (e):
(1) Category 1 food establishments.--A category 1 food
establishment shall be subject to antemortem, postmortem, and
continuous inspection of each slaughter line during all
operating hours, and other inspection on a daily basis,
sufficient to verify that--
(A) diseased animals are not offered for slaughter;
(B) the food establishment has successfully identified and
removed from the slaughter line visibly defective or
contaminated carcasses, has avoided cross-contamination, and
destroyed or reprocessed them in a manner acceptable to the
Administrator; and
(C) that applicable performance standards and other
provisions of the food safety law, including those intended
to eliminate or reduce pathogens, have been satisfied.
(2) Category 2 food establishments.--A category 2 food
establishment shall be randomly inspected at least daily.
(3) Category 3 food establishments.--A category 3 food
establishment shall--
(A) have ongoing verification that its processes are
controlled; and
(B) be randomly inspected at least monthly.
(4) Category 4 food establishments.--A category 4 food
establishment shall be randomly inspected at least quarterly.
(5) Category 5 food establishments.--A category 5 food
establishment shall be randomly inspected at least annually.
(c) Establishment of Inspection Procedures.--The
Administrator shall establish procedures under which
inspectors or safety officers shall take random samples,
photographs, and copies of records in food establishments.
(d) Alternative Inspection Frequencies.--With respect to a
category 2, 3, 4, or 5 food establishment, the Administrator
may establish alternative increasing or decreasing inspection
frequencies for subcategories of food establishments or
individual establishments, to foster risk-based allocation of
resources, subject to the following criteria and procedures:
(1) Subcategories of food establishments and their
alternative inspection frequencies shall be defined by
regulation, subject to paragraphs (2) and (3).
(2) Regulations of alternative inspection frequencies for
subcategories of food establishments under paragraph (1) and
for a specific food establishment under paragraph (4) shall
provide that--
(A) category 2 food establishments shall be inspected at
least monthly; and
(B) category 3, 4, and 5 food establishments shall be
inspected at least annually.
(3) In defining subcategories of food establishments and
their alternative inspection frequencies under paragraphs (1)
and (2), the Administrator shall consider--
(A) the nature of the food products being processed,
stored, or transported;
(B) the manner in which food products are processed,
stored, or transported;
(C) the inherent likelihood that the products will
contribute to the risk of food-borne illness;
(D) the best available evidence concerning reported
illnesses associated with the foods produced in the proposed
subcategory of establishments; and
(E) the overall record of compliance with the food safety
law among establishments in the proposed subcategory,
including compliance with applicable performance standards
and the frequency of recalls.
(4) The Administrator may adopt alternative inspection
frequencies for increased or decreased inspection for a
specific establishment, subject to paragraphs (2) and (5) and
shall periodically publish a list of establishments subject
to alternative inspections.
(5) In adopting alternative inspection frequencies for a
specific establishment, the Administrator shall consider--
(A) the criteria in paragraph (3);
(B) whether products from the specific establishment have
been associated with a case or an outbreak of food-borne
illness; and
(C) the record of the establishment of compliance with the
food safety law, including compliance with applicable
performance standards and the frequency of recalls.
(6) Before establishing decreased alternative inspection
frequencies for subcategories of establishments or individual
establishments, the Administrator shall--
(A) determine, based on the best available evidence, that
the alternative uses of the resources required to carry out
the inspection activity would make a greater contribution to
protecting the public health and reducing the risk of food-
borne illness than the use of resources described in
subsection (b);
(B) describe the alternative uses of resources in general
terms when issuing the regulation or order that establishes
the alternative inspection frequency;
(C) consider the supporting evidence that an individual
food establishment shall submit related to whether an
alternative inspection frequency should be established for
such establishment by the Administrator; and
(D) include a description of the alternative uses in the
annual resource plan required in section 209.
(e) Inspection Transition.--The Administrator shall manage
the transition to the inspection system described in this Act
as follows:
(1) In the case of a category 1 or 2 food establishment,
the Administrator shall continue to implement the applicable
inspection mandates of the Federal Meat Inspection Act (21
U.S.C. 601 et seq.), the Poultry Products Inspection Act (21
U.S.C. 451 et seq.), and the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.) until--
(A) regulations required to implement this section have
been promulgated;
(B) the performance standards required by section 204(c)
have been promulgated and implemented for 1 year; and
(C) the establishment has achieved compliance with the
other applicable provisions of the food safety law.
(2) In the case of a category 1 or 2 food establishment
that, within 2 years after the promulgation of the
performance standards required by section 204(c), has not
achieved compliance with the food safety law, the
Administrator shall--
(A) issue an order prohibiting the establishment from
operating pending a demonstration by the establishment that
sufficient changes in facilities, procedures, personnel, or
other aspects of the process control system have been made
such that the Administrator determines that compliance with
the food safety law is achieved; and
(B) following the demonstration required in subparagraph
(A), issue an order authorizing the food establishment to
operate subject, at a minimum, to--
(i) the inspection requirement applicable to the
establishment under subsection (b) (1) or (2); and
(ii) such other inspection or compliance measures
determined by the Administrator necessary to assure
compliance with the applicable food safety law.
(3) In the case of a category 3 food establishment, the
Administrator shall continue to implement the applicable
inspection mandates of the Federal Meat Inspection Act (21
U.S.C. 601 et seq.), the Poultry Products Inspection Act (21
U.S.C. 451 et seq.), and the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.) until--
(A) the regulations required to implement this section have
been promulgated;
(B) the first resource plan under section 209 has been
submitted; and
(C) for individual establishments, compliance with the food
safety law has been demonstrated.
(4) In the case of a category 3 food establishment that,
within 1 year after the promulgation of the regulations
required to implement this section, have not demonstrated
compliance with the food safety law, the Administrator
shall--
(A) issue an order prohibiting the establishment from
operating, pending a demonstration by the establishment that
sufficient changes in facilities, procedures, personnel, or
other aspects of the process control system have been made
such that the Administrator determines that compliance with
the food safety law is achieved; and
(B) following the demonstration required in subparagraph
(A), issue an order authorizing the establishment to operate
subject, at a minimum, to--
(i) the inspection requirement applicable to the
establishment under subsection (b)(3); and
(ii) such other inspection or compliance measures
determined by the Administrator necessary to assure
compliance with the food safety law.
(5) In the case of a category 4 or 5 food establishment,
the inspection requirements of this Act shall be implemented
as soon as possible after--
(A) the promulgation of the regulations required to
implement this section;

[[Page S2106]]

(B) the publication of the first resource plan under
section 209; and
(C) the commencement of the first fiscal year in which the
Administration is operating with budgetary resources that
Congress has appropriated following consideration of the
resource plan under section 209.
(f) Official Mark.--
(1) In general.--
(A) Establishment.--Before the completion of the transition
process under paragraphs (1) through (3) of subsection (e),
the Administrator shall by regulation establish an official
mark that shall be affixed to a food product produced in a
category 1, 2, or 3 establishment, subject to subparagraph
(B).
(B) Prerequisite.--The official mark required under
subparagraph (A) shall be affixed to a food product by the
Administrator if the establishment has been inspected by the
Administrator in accordance with the inspection frequencies
under this section and the establishment is in compliance
with the food safety law.
(C) Removal of official mark.--The Administrator shall
promulgate regulations that provide for the removal of the
official mark under this subsection if the Administrator
makes a finding that the establishment is not in compliance
with the food safety law.
(2) Category 1, 2, or 3 food establishments.--In the case
of products produced in a category 1, 2, or 3 food
establishment--
(A) products subject to Federal Meat Inspection Act (21
U.S.C. 601 et seq.), the Poultry Products Inspection Act (21
U.S.C. 451 et seq.), the Egg Products Inspection Act (21
U.S.C. 1031 et seq.), and the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) as of the date of
enactment of this Act shall remain subject to the requirement
under those Acts that they bear the mark of inspection
pending completion of the transition process under paragraphs
(1) through (3) of subsection (e);
(B) the Administrator shall publicly certify on a monthly
basis that the inspection frequencies required under this Act
have been achieved; and
(C) a product from an establishment that has not been
inspected in accordance with the required frequencies under
this section shall not bear the official mark and shall not
be shipped in interstate commerce.
(3) Category 4 and 5 food establishments.--In the case of a
product produced in a category 4 or 5 food establishment the
Administrator shall provide by regulation for the voluntary
use of the official mark established under paragraph (1),
subject to--
(A) such minimum inspection frequencies as determined
appropriate by the Administrator;
(B) compliance with applicable performance standards and
other provisions of the food safety law; and
(C) such other requirements the Administrator considers
appropriate.
(g) Implementation.--Not later than 1 year after the
effective date of this Act, the Administrator shall issue
regulations to implement subsections (b) through (e).
(h) Maintenance and Inspection of Records.--
(1) In general.--
(A) Records.--A food establishment shall--
(i) maintain such records as the Administrator shall
require by regulation, including all records relating to the
processing, distributing, receipt, or importation of any
food; and
(ii) permit the Administrator, in addition to any authority
of the food safety agencies in effect on the day before the
date of enactment of this Act, upon presentation of
appropriate credentials and at reasonable times and in a
reasonable manner, to have access to and copy all records
maintained by or on behalf of such food establishment
representative in any format (including paper or electronic)
and at any location, that are necessary to assist the
Administrator--

(I) to determine whether the food is contaminated or not in
compliance with the food safety law; or
(II) to track the food in commerce.

(B) Required disclosure.--A food establishment shall have
an affirmative obligation to disclose to the Administrator
the results of testing or sampling of food, equipment, or
material in contact with food, that is positive for any
contaminant.
(2) Maintenance of records.--The records in paragraph (1)
shall be maintained for a reasonable period of time, as
determined by the Administrator.
(3) Requirements.--The records in paragraph (1) shall
include records describing--
(A) the origin, receipt, delivery, sale, movement, holding,
and disposition of food or ingredients;
(B) the identity and quantity of ingredients used in the
food;
(C) the processing of the food;
(D) the results of laboratory, sanitation, or other tests
performed on the food or in the food establishment;
(E) consumer complaints concerning the food or packaging of
the food;
(F) the production codes, open date codes, and locations of
food production; and
(G) other matters reasonably related to whether food is
unsafe, is adulterated or misbranded, or otherwise fails to
meet the requirements of this Act.
(i) Protection of Sensitive Information.--
(1) In general.--The Administrator shall develop and
maintain procedures to prevent the unauthorized disclosure of
any trade secret or confidential information obtained by the
Administrator.
(2) Limitation.--The requirement under this subsection does
not--
(A) limit the authority of the Administrator to inspect or
copy records or to require the establishment or maintenance
of records under this Act;
(B) have any legal effect on section 1905 of title 18,
United States Code;
(C) extend to any food recipe, financial data, pricing
data, personnel data, or sales data (other than shipment
dates relating to sales);
(D) limit the public disclosure of distribution records or
other records related to food subject to a voluntary or
mandatory recall under section 403; or
(E) limit the authority of the Administrator to promulgate
regulations to permit the sharing of data with other
governmental authorities.
(j) Bribery of or Gifts to Inspector or Other Officers and
Acceptance of Gifts.--Section 22 of the Federal Meat
Inspection Act (21 U.S.C. 622) shall apply under this Act.

SEC. 206. FOOD PRODUCTION FACILITIES.

In carrying out the duties of the Administrator and the
purposes of this Act, the Administrator shall have the
authority, with respect to food production facilities, to--
(1) visit and inspect food production facilities in the
United States and in foreign countries to investigate
bioterrorism threats and for other critical food safety
purposes;
(2) review food safety records as required to be kept by
the Administrator to carry out traceback and for other
critical food safety purposes;
(3) set good practice standards to protect the public and
animal health and promote food safety;
(4) conduct monitoring and surveillance of animals, plants,
products, or the environment, as appropriate; and
(5) collect and maintain information relevant to public
health and farm practices.

SEC. 207. FEDERAL AND STATE COOPERATION.

(a) In General.--The Administrator shall work with the
States to carry out activities and programs that create a
national food safety program so that Federal and State
programs function in a coordinated and cost-effective manner.
(b) State Action.--The Administrator shall work with States
to--
(1) continue, strengthen, or establish State food safety
programs, especially with respect to the regulation of retail
commercial food establishments, transportation, harvesting,
and fresh markets;
(2) continue, strengthen, or establish inspection programs
and requirements to ensure that food under the jurisdiction
of the State is safe; and
(3) support recall authorities at the State and local
levels.
(c) Assistance.--To assist in planning, developing, and
implementing a food safety program, the Administrator may
provide and continue to a State--
(1) advisory assistance;
(2) technical and laboratory assistance and training
(including necessary materials and equipment); and
(3) financial, in kind, and other aid.
(d) Service Agreements.--
(1) In general.--The Administrator may, under agreements
entered into with Federal, State, or local agencies, use on a
reimbursable basis or otherwise, the personnel and services
of those agencies in carrying out this Act.
(2) Training.--Agreements with a State under this
subsection may provide for training of State employees.
(3) Maintenance of agreements.--The Administrator shall
maintain any agreement that is in effect on the day before
the date of enactment of this Act until the Administrator
evaluates such agreement and determines whether to maintain
or substitute such agreement.
(e) Audits.--
(1) In general.--The Administrator shall annually conduct a
comprehensive review of each State program that provides
services to the Administrator in carrying out the
responsibilities under this Act, including mandated
inspections under section 205.
(2) Requirements.--The review shall--
(A) include a determination of the effectiveness of the
State program; and
(B) identify any changes necessary to ensure enforcement of
Federal requirements under this Act.
(f) No Federal Preemption.--Nothing in this Act shall be
construed to preempt the enforcement of State food safety
laws and standards that are at least as stringent as those
under this Act.

SEC. 208. IMPORTS.

(a) In General.--Not later than 2 years after the effective
date of this Act, the Administrator shall establish a system
under which a foreign government or foreign food
establishment seeking to import food to the United States
shall submit a request for certification to the
Administrator.
(b) Certification Standard.--A foreign government or
foreign food establishment requesting a certification to
import food to the United States shall demonstrate, in a
manner determined appropriate by the Administrator, that food
produced under the supervision of a foreign government or by
the foreign food establishment has met standards for food
safety, inspection, labeling, and consumer protection that
are at least equivalent to standards applicable to food
produced in the United States.
(c) Certification Approval.--

[[Page S2107]]

(1) Request by foreign government.--Prior to granting the
certification request of a foreign government, the
Administrator shall review, audit, and certify the food
safety program of a requesting foreign government (including
all statutes, regulations, and inspection authority) as at
least equivalent to the food safety program in the United
States, as demonstrated by the foreign government.
(2) Request by foreign food establishment.--Prior to
granting the certification request of a foreign food
establishment, the Administrator shall certify, based on an
onsite inspection, the food safety programs and procedures of
a requesting foreign firm as at least equivalent to the food
safety programs and procedures of the United States.
(d) Limitation.--A foreign government or foreign firm
approved by the Administrator to import food to the United
States under this section shall be certified to export only
the approved food products to the United States for a period
not to exceed 5 years.
(e) Withdrawal of Certification.--The Administrator may
withdraw certification of any food from a foreign government
or foreign firm--
(1) if such food is linked to an outbreak of human illness;
(2) following an investigation by the Administrator that
finds that the foreign government programs and procedures or
foreign food establishment is no longer equivalent to the
food safety programs and procedures in the United States; or
(3) following a refusal to allow United States officials to
conduct such audits and investigations as may be necessary to
fulfill the requirements under this section.
(f) Renewal of Certification.--The Administrator shall
audit foreign governments and foreign food establishments at
least every 5 years to ensure the continued compliance with
the standards set forth in this section.
(g) Required Routine Inspection.--The Administrator shall
routinely inspect food and food animals (via a physical
examination) before it enters the United States to ensure
that it is--
(1) safe;
(2) labeled as required for food produced in the United
States; and
(3) otherwise meets requirements under the food safety law.
(h) Enforcement.--The Administrator is authorized to--
(1) deny importation of food from any foreign government
that does not permit United States officials to enter the
foreign country to conduct such audits and inspections as may
be necessary to fulfill the requirements under this section;
(2) deny importation of food from any foreign government or
foreign firm that does not consent to an investigation by the
Administration when food from that foreign country or foreign
firm is linked to a food-borne illness outbreak or is
otherwise found to be adulterated or mislabeled; and
(3) promulgate rules and regulations to carry out the
purposes of this section, including setting terms and
conditions for the destruction of products that fail to meet
the standards of this Act.
(i) Detention and Seizure.--Any food imported for
consumption in the United States may be detained, seized, or
condemned pursuant to section 402.

SEC. 209. RESOURCE PLAN.

(a) In General.--The Administrator shall prepare and update
annually a resource plan describing the resources required,
in the best professional judgment of the Administrator, to
develop and fully implement the national food safety program
established under this Act.
(b) Contents of Plan.--The resource plan shall--
(1) describe quantitatively the personnel, financial, and
other resources required to carry out the inspection of food
establishments under section 205 and other requirements of
the national food safety program;
(2) allocate inspection resources in a manner reflecting
the distribution of risk and opportunities to reduce risk
across the food supply to the extent feasible based on the
best available information, and subject to section 205; and
(3) describe the personnel, facilities, equipment, and
other resources needed to carry out inspection and other
oversight activities, at a total resource level equal to at
least 50 percent of the resources required to carry out
inspections in food establishments under section 205--
(A) in foreign establishments;
(B) at the point of importation; and
(C) at the point of production on farms, ranches, and
feedlots.
(c) Grants.--The resource plan shall include
recommendations for funding to provide grants to States and
local governments to carry out food safety activities in
retail and food service facilities and the required
inspections in food establishments.
(d) Submission of Plan.--The Administrator shall submit
annually to the Committee on Appropriations of the Senate,
the Committee on Appropriations of the House of
Representatives, and other relevant committees of Congress,
the resource plan required under this section.

SEC. 210. TRACEBACK.

(a) In General.--The Administrator, in order to protect the
public health, shall establish requirements for a national
system for tracing food and food producing animals from point
of origin to retail sale, subject to subsection (b).
(b) Applicability.--Traceability requirements shall--
(1) be established in accordance with regulations and
guidelines issued by the Administrator; and
(2) apply to food production facilities and food
establishments.
(c) Relationship to Country of Origin Labeling.--Nothing
contained in this section prevents or interferes with
implementation of the country of origin labeling requirements
of subtitle D of the Agricultural Marketing Act of 1946 (7
U.S.C. 1638 et seq.).

TITLE III--RESEARCH AND EDUCATION

SEC. 301. PUBLIC HEALTH ASSESSMENT SYSTEM.

(a) In General.--The Administrator, acting in coordination
with the Director of the Centers for Disease Control and
Prevention and with the Research Education and Economics
mission area of the Department of Agriculture, shall--
(1) have access to the applicable data systems of the
Centers for Disease Control and Prevention and to the
databases made available by a State;
(2) maintain an active surveillance system of food, food
products, and epidemiological evidence submitted by States to
the Centers for Disease Control and Prevention based on a
representative proportion of the population of the United
States;
(3) assess the frequency and sources of human illness in
the United States associated with the consumption of food;
(4) maintain a state-of-the-art DNA matching system and
epidemiological system dedicated to food-borne illness
identification, outbreaks, and containment; and
(5) have access to the surveillance data created via
monitoring and statistical studies conducted as part of its
own inspection.
(b) Public Health Sampling.--
(1) In general.--Not later than 1 year after the effective
date of this Act, the Administrator shall establish
guidelines for a sampling system under which the
Administrator shall take and analyze samples of food--
(A) to assist the Administrator in carrying out this Act;
and
(B) to assess the nature, frequency of occurrence, and
quantities of contaminants in food.
(2) Requirements.--The sampling system described in
paragraph (1) shall provide--
(A) statistically valid monitoring, including market-based
studies, on the nature, frequency of occurrence, and
quantities of contaminants in food available to consumers;
and
(B) at the request of the Administrator, such other
information, including analysis of monitoring and
verification samples, as the Administrator determines may be
useful in assessing the occurrence of contaminants in food.
(c) Assessment of Health Hazards.--
(1) In general.--Through the surveillance system referred
to in subsection (a) and the sampling system described in
subsection (b), the Administrator shall--
(A) rank food categories based on the hazard to human
health presented by the food category;
(B) identify appropriate industry and regulatory approaches
to minimize hazards in the food supply; and
(C) assess the public health environment for emerging
diseases, including zoonosis, for their risk of appearance in
the United States food supply.
(2) Components of analysis.--The analysis under subsection
(b)(1) may include--
(A) a comparison of the safety of commercial processing
with the health hazards associated with food that is
harvested for recreational or subsistence purposes and
prepared noncommercially;
(B) a comparison of the safety of food that is domestically
processed with the health hazards associated with food that
is processed outside the United States;
(C) a description of contamination originating from
handling practices that occur prior to or after the sale of
food to consumers; and
(D) use of comparative risk assessments.

SEC. 302. PUBLIC EDUCATION AND ADVISORY SYSTEM.

(a) Public Education.--
(1) In general.--The Administrator, in cooperation with
private and public organizations, including the cooperative
extension services and building on the efforts of appropriate
State and local entities, shall establish a national public
education program on food safety.
(2) Requirements.--The program shall provide--
(A) information to the public regarding Federal standards
and best practices and promotion of public awareness,
understanding, and acceptance of those standards and
practices;
(B) information for health professionals--
(i) to improve diagnosis and treatment of food-related
illness; and
(ii) to advise individuals at special risk for food-related
illnesses; and
(C) such other information or advice to consumers and other
persons as the Administrator determines will promote the
purposes of this Act.
(b) Health Advisories.--The Administrator, in consultation
with other Federal departments and agencies as the
Administrator determines necessary, shall work with the
States and other appropriate entities--
(1) to develop and distribute regional and national
advisories concerning food safety;
(2) to develop standardized formats for written and
broadcast advisories;

[[Page S2108]]

(3) to incorporate State and local advisories into the
national public education program established under
subsection (a); and
(4) to present prompt, specific information regarding foods
found to pose a threat to the public health.

SEC. 303. RESEARCH.

(a) In General.--The Administrator shall conduct research
to carry out this Act, including studies to--
(1) improve sanitation and food safety practices in the
processing of food;
(2) develop improved techniques to monitor and inspect
food;
(3) develop efficient, rapid, and sensitive methods to
detect contaminants in food;
(4) determine the sources of contamination of contaminated
food;
(5) develop food consumption data;
(6) identify ways that animal production techniques could
improve the safety of the food supply;
(7) draw upon research and educational programs that exist
at the State and local level;
(8) utilize the DNA matching system and other processes to
identify and control pathogens;
(9) address common and emerging zoonotic diseases;
(10) develop methods to reduce or destroy harmful pathogens
before, during, and after processing;
(11) analyze the incidence of antibiotic resistence as it
pertains to the food supply and develop new methods to reduce
the transfer of antibiotic resistance to humans; and
(12) conduct other research that supports the purposes of
this Act.
(b) Contract Authority.--The Administrator may enter into
contracts and agreements with any State, university, Federal
Government agency, or person to carry out this section.

TITLE IV--ENFORCEMENT

SEC. 401. PROHIBITED ACTS.

It is prohibited--
(1) to manufacture, introduce, deliver for introduction, or
receive into interstate commerce any food that is
adulterated, misbranded, or otherwise unsafe;
(2) to adulterate or misbrand any food in interstate
commerce;
(3) for a food establishment or foreign food establishment
to fail to register under section 202, or to operate without
a valid registration;
(4) to refuse to permit access to a food establishment for
the inspection and copying of a record as required under
section 205(h);
(5) to fail to establish or maintain any record or to make
any report as required under section 205(h);
(6) to refuse to permit entry to or inspection of a food
establishment as required under section 205;
(7) to fail to provide to the Administrator the results of
a testing or sampling of a food, equipment, or material in
contact with contaminated food under section 205(i);
(8) to fail to comply with a provision, regulation, or
order of the Administrator under section 202, 203, 204, or
208;
(9) to slaughter an animal that is capable for use in whole
or in part as human food at a food establishment processing
any such food for commerce, except in compliance with the
food safety law;
(10) to transfer food in violation of an administrative
detention order under section 402 or to remove or alter a
required mark or label identifying the food as detained;
(11) to fail to comply with a recall or other order under
section 403; or
(12) to otherwise violate the food safety law.

SEC. 402. FOOD DETENTION, SEIZURE, AND CONDEMNATION.

(a) Administrative Detention of Food.--
(1) Expanded authority.--The Administrator shall have
authority under section 304 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 334) to administratively detain and
seize any food that the Administrator has reason to believe
is unsafe, is adulterated or misbranded, or otherwise fails
to meet the requirements of the food safety law.
(2) Detention authority.--If, during an inspection
conducted in accordance with section 205 or 208, an officer,
employee, or agent of the Administration making the
inspection has reason to believe that a domestic food,
imported food, or food offered for import is unsafe, is
adulterated or misbranded, or otherwise fails to meet the
requirements of this Act, the officer or employee may order
the food detained.
(3) Period of detention.--
(A) In general.--A food may be detained for a reasonable
period, not to exceed 20 days, unless a longer period, not to
exceed 30 days, is necessary for the Administrator to
institute a seizure action.
(B) Perishable food.--The Administrator shall provide by
regulation for procedures to institute a seizure action on an
expedited basis with respect to perishable food.
(4) Security of detained food.--
(A) In general.--A detention order--
(i) may require that the food be labeled or marked as
detained; and
(ii) shall require that the food be removed to a secure
facility, if appropriate.
(B) Food subject to an order.--A food subject to a
detention order shall not be transferred by any person from
the place at which the food is removed, until released by the
Administrator or until the expiration of the detention period
applicable under the order, whichever occurs first.
(C) Delivery of food.--This subsection does not authorize
the delivery of a food in accordance with execution of a bond
while the article is subject to the order.
(b) Appeal of Detention Order.--
(1) In general.--A person who would be entitled to be a
claimant for a food subject to a detention order if the food
were seized under section 304 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 334), may appeal the order to the
Administrator.
(2) Action by the administrator.--Not later than 5 days
after an appeal is filed under paragraph (1), the
Administrator, after providing an opportunity for an informal
hearing, shall confirm, modify, or terminate the order
involved.
(3) Final agency action.--Confirmation, modification, or
termination by the Administrator under paragraph (2) shall be
considered a final agency action for purposes of section 702
of title 5, United States Code.
(4) Termination.--The order shall be considered to be
terminated if, after 5 days, the Administrator has failed--
(A) to provide an opportunity for an informal hearing; or
(B) to confirm, modify, or terminate the order.
(5) Effect of instituting court action.--If the
Administrator initiates an action under section 302 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 332) or
section 304(a) of that Act (21 U.S.C. 334(a)), the process
for the appeal of the detention order shall terminate.
(c) Condemnation of Food.--
(1) In general.--After confirming a detention order, the
Administrator may order the food condemned.
(2) Destruction of food.--Any food condemned shall be
destroyed under the supervision of the Administrator.
(3) Release of food.--If the Administrator determines that,
through reprocessing, relabeling, or other action, a detained
food can be brought into compliance with this Act, the food
may be released following a determination by the
Administrator that the relabeling or other action as
specified by the Administrator has been performed.
(d) Temporary Holds at Ports of Entry.--
(1) In general.--If an officer or qualified employee of the
Administration has reason to believe that a food is unsafe,
is adulterated or misbranded, or otherwise fails to meet the
requirements of this Act, and the officer or qualified
employee is unable to inspect, examine, or investigate the
food when the food is offered for import at a port of entry
into the United States, the officer or qualified employee
shall request the Secretary of Homeland Security to hold the
food at the port of entry for a reasonable period of time,
not to exceed 24 hours, to enable the Administrator to
inspect or investigate the food as appropriate.
(2) Removal to secure facility.--The Administrator shall
work in coordination with the Secretary of Homeland Security
to remove a food held in accordance with paragraph (1) to a
secure facility as appropriate.
(3) Prohibition on transfer.--During the period in which
the food is held, the food shall not be transferred by any
person from the port of entry into the United States, or from
the secure facility to which the food has been removed.
(4) Delivery in accordance with a bond.--The delivery of
the food in accordance with the execution of a bond while the
food is held is not authorized.
(5) Prohibition on reexport.--A food found unfit for human
or animal consumption shall be prohibited from reexport
without further processing to remove the contamination and
reinspection by the Administration.

SEC. 403. NOTIFICATION AND RECALL.

(a) Notice to Administrator of Violation.--
(1) In general.--A person that has reason to believe that
any food introduced into or in interstate commerce, or held
for sale (whether or not the first sale) after shipment in
interstate commerce, may be in violation of the food safety
law shall immediately notify the Administrator of the
identity and location of the food.
(2) Manner of notification.--Notification under paragraph
(1) shall be made in such manner and by such means as the
Administrator may require by regulation.
(b) Recall and Consumer Notification.--
(1) Voluntary actions.--If the Administrator determines
that food is in violation of the food safety law when
introduced into or while in interstate commerce or while held
for sale (whether or not the first sale) after shipment in
interstate commerce and that there is a reasonable
probability that the food, if consumed, would present a
threat to public health, as determined by the Administrator,
the Administrator shall give the appropriate persons
(including the manufacturers, importers, distributors, or
retailers of the food) an opportunity to--
(A) cease distribution of the food;
(B) notify all persons--
(i) processing, distributing, or otherwise handling the
food to immediately cease such activities with respect to the
food; or
(ii) to which the food has been distributed, transported,
or sold, to immediately cease distribution of the food;
(C) recall the food;
(D) in conjunction with the Administrator, provide notice
of the finding of the Administrator--

[[Page S2109]]

(i) to consumers to whom the food was, or may have been,
distributed; and
(ii) to State and local public health officials; or
(E) take any combination of the measures described in this
paragraph, as determined by the Administrator to be
appropriate in the circumstances.
(2) Mandatory actions.--If a person referred to in
paragraph (1) refuses to or does not adequately carry out the
actions described in that paragraph within the time period
and in the manner prescribed by the Administrator, the
Administrator shall--
(A) have authority to control and possess the food,
including ordering the shipment of the food from the food
establishment to the Administrator--
(i) at the expense of the food establishment; or
(ii) in an emergency (as determined by the Administrator),
at the expense of the Administration; and
(B) by order, require, as the Administrator determines to
be necessary, the person to immediately--
(i) cease distribution of the food; and
(ii) notify all persons--

(I) processing, distributing, or otherwise handling the
food to immediately cease such activities with respect to the
food; or
(II) if the food has been distributed, transported, or
sold, to immediately cease distribution of the food.

(3) Notification to consumers by administrator.--The
Administrator shall, as the Administrator determines to be
necessary, provide notice of the finding of the Administrator
under paragraph (1)--
(A) to consumers to whom the food was, or may have been,
distributed; and
(B) to State and local public health officials.
(4) Nondistribution by notified persons.--A person that
processes, distributes, or otherwise handles the food, or to
which the food has been distributed, transported, or sold,
and that is notified under paragraph (1)(B) or (2)(B) shall
immediately cease distribution of the food.
(5) Availability of records to administrator.--Each person
referred to in paragraph (1) that processed, distributed, or
otherwise handled food shall make available to the
Administrator information necessary to carry out this
subsection, as determined by the Administrator, regarding--
(A) persons that processed, distributed, or otherwise
handled the food; and
(B) persons to which the food has been transported, sold,
distributed, or otherwise handled.
(c) Informal Hearings on Orders.--
(1) In general.--The Administrator shall provide any person
subject to an order under subsection (b) with an opportunity
for an informal hearing, to be held as soon as practicable
but not later than 2 business days after the issuance of the
order.
(2) Scope of the hearing.--In a hearing under paragraph
(1), the Administrator shall consider the actions required by
the order and any reasons why the food that is the subject of
the order should not be recalled.
(d) Post-Hearing Recall Orders.--
(1) Amendment of order.--If, after providing an opportunity
for an informal hearing under subsection (c), the
Administrator determines that there is a reasonable
probability that the food that is the subject of an order
under subsection (b), if consumed, would present a threat to
the public health, the Administrator, as the Administrator
determines to be necessary, may--
(A) amend the order to require recall of the food or other
appropriate action;
(B) specify a timetable in which the recall shall occur;
(C) require periodic reports to the Administrator
describing the progress of the recall; and
(D) provide notice of the recall to consumers to whom the
food was, or may have been, distributed.
(2) Vacation of orders.--If, after providing an opportunity
for an informal hearing under subsection (c), the
Administrator determines that adequate grounds do not exist
to continue the actions required by the order, the
Administrator shall vacate the order.
(e) Remedies Not Exclusive.--The remedies provided in this
section shall be in addition to, and not exclusive of, other
remedies that may be available.

SEC. 404. INJUNCTION PROCEEDINGS.

(a) Jurisdiction.--The district courts of the United
States, and the United States courts of the territories and
possessions of the United States, shall have jurisdiction,
for cause shown, to restrain a violation of section 202, 203,
204, 207, or 401 (or a regulation promulgated under that
section).
(b) Trial.--In a case in which violation of an injunction
or restraining order issued under this section also
constitutes a violation of the food safety law, trial shall
be by the court or, upon demand of the accused, by a jury.

SEC. 405. CIVIL AND CRIMINAL PENALTIES.

(a) Civil Sanctions.--
(1) Civil penalty.--
(A) In general.--Any person that commits an act that
violates the food safety law (including a regulation
promulgated or order issued under a Federal food safety law)
may be assessed a civil penalty by the Administrator of not
more than $10,000 for each such act.
(B) Separate offense.--Each act described in subparagraph
(A) and each day during which that act continues shall be
considered a separate offense.
(2) Other requirements.--
(A) Written order.--The civil penalty described in
paragraph (1) shall be assessed by the Administrator by a
written order, which shall specify the amount of the penalty
and the basis for the penalty under subparagraph (B)
considered by the Administrator.
(B) Amount of penalty.--Subject to paragraph (1)(A), the
amount of the civil penalty shall be determined by the
Administrator, after considering--
(i) the gravity of the violation;
(ii) the degree of culpability of the person;
(iii) the size and type of the business of the person; and
(iv) any history of prior offenses by the person under the
food safety law.
(C) Review of order.--The order may be reviewed only in
accordance with subsection (c).
(b) Criminal Sanctions.--
(1) In general.--Except as provided in paragraphs (2) and
(3), a person that knowingly produces or introduces into
commerce food that is unsafe or otherwise adulterated or
misbranded shall be imprisoned for not more than 1 year or
fined not more than $10,000, or both.
(2) Severe violations.--A person that commits a violation
described in paragraph (1) after a conviction of that person
under this section has become final, or commits such a
violation with the intent to defraud or mislead, shall be
imprisoned for not more than 3 years or fined not more than
$100,000, or both.
(3) Exception.--No person shall be subject to the penalties
of this subsection--
(A) for having received, proffered, or delivered in
interstate commerce any food, if the receipt, proffer, or
delivery was made in good faith, unless that person refuses
to furnish (on request of an officer or employee designated
by the Administrator)--
(i) the name, address and contact information of the person
from whom that person purchased or received the food;
(ii) copies of all documents relating to the person from
whom that person purchased or received the food; and
(iii) copies of all documents pertaining to the delivery of
the food to that person; or
(B) if that person establishes a guaranty signed by, and
containing the name and address of, the person from whom that
person received in good faith the food, stating that the food
is not adulterated or misbranded within the meaning of this
Act.
(c) Judicial Review.--
(1) In general.--An order assessing a civil penalty under
subsection (a) shall be a final order unless the person--
(A) not later than 30 days after the effective date of the
order, files a petition for judicial review of the order in
the United States court of appeals for the circuit in which
that person resides or has its principal place of business or
the United States Court of Appeals for the District of
Columbia; and
(B) simultaneously serves a copy of the petition by
certified mail to the Administrator.
(2) Filing of record.--Not later than 45 days after the
service of a copy of the petition under paragraph (1)(B), the
Administrator shall file in the court a certified copy of the
administrative record upon which the order was issued.
(3) Standard of review.--The findings of the Administrator
relating to the order shall be set aside only if found to be
unsupported by substantial evidence on the record as a whole.
(d) Collection Actions for Failure To Pay.--
(1) In general.--If any person fails to pay a civil penalty
assessed under subsection (a) after the order assessing the
penalty has become a final order, or after the court of
appeals described in subsection (b) has entered final
judgment in favor of the Administrator, the Administrator
shall refer the matter to the Attorney General, who shall
institute in a United States district court of competent
jurisdiction a civil action to recover the amount assessed.
(2) Limitation on review.--In a civil action under
paragraph (1), the validity and appropriateness of the order
of the Administrator assessing the civil penalty shall not be
subject to judicial review.
(e) Penalties Paid Into Account.--The Administrator--
(1) shall deposit penalties collected under this section in
an account in the Treasury; and
(2) may use the funds in the account, without further
appropriation or fiscal year limitation--
(A) to carry out enforcement activities under food safety
law; or
(B) to provide assistance to States to inspect retail
commercial food establishments or other food or firms under
the jurisdiction of State food safety programs.
(f) Discretion of the Administrator to Prosecute.--Nothing
in this Act requires the Administrator to report for
prosecution, or for the commencement of an action, the
violation of the food safety law in a case in which the
Administrator finds that the public interest will be
adequately served by the assessment of a civil penalty under
this section.
(g) Remedies Not Exclusive.--The remedies provided in this
section may be in addition to, and not exclusive of, other
remedies that may be available.

[[Page S2110]]

SEC. 406. PRESUMPTION.

In any action to enforce the requirements of the food
safety law, the connection with interstate commerce required
for jurisdiction shall be presumed to exist.

SEC. 407. WHISTLEBLOWER PROTECTION.

(a) In General.--No Federal employee, employee of a Federal
contractor or subcontractor, or any individual employed by a
company (referred to in this section as a ``covered
individual''), may be discharged, demoted, suspended,
threatened, harassed, or in any other manner discriminated
against, because of any lawful act done by the covered
individual to--
(1) provide information, cause information to be provided,
or otherwise assist in an investigation regarding any conduct
that the covered individual reasonably believes constitutes a
violation of any law, rule, or regulation, or that the
covered individual reasonably believes constitutes a threat
to the public health, when the information or assistance is
provided to, or the investigation is conducted by--
(A) a Federal regulatory or law enforcement agency;
(B) a Member or committee of Congress; or
(C) a person with supervisory authority over the covered
individual (or such other individual who has the authority to
investigate, discover, or terminate misconduct);
(2) file, cause to be filed, testify, participate in, or
otherwise assist in a proceeding or action filed or about to
be filed relating to a violation of any law, rule, or
regulation; or
(3) refused to violate or assist in the violation of any
law, rule, or regulation.
(b) Enforcement Action.--
(1) In general.--A covered individual who alleges discharge
or other discrimination by any person in violation of
subsection (a) may seek relief under subsection (c) by filing
a complaint with the Secretary of Labor. If the Secretary of
Labor has not issued a final decision within 180 days after
the date on which the complaint is filed and there is no
showing that such delay is due to the bad faith of the
claimant, the claimant may bring an action at law or equity
for de novo review in the appropriate district court of the
United States, which shall have jurisdiction over such an
action without regard to the amount in controversy.
(2) Procedure.--
(A) In general.--An action under paragraph (1) shall be
governed under the rules and procedures set forth in section
42121(b) of title 49, United States Code.
(B) Exception.--Notification under section 42121(b)(1) of
title 49, United States Code, shall be made to the person
named in the complaint and to the person's employer.
(C) Burdens of proof.--An action brought under paragraph
(1) shall be governed by the legal burdens of proof set for
in section 42121(b) of title 49, United States Code.
(D) Statute of limitations.--An action under paragraph (1)
shall be commenced not later than 90 days after the date on
which the violation occurs.
(c) Remedies.--
(1) In general.--A covered individual prevailing in any
action under subsection (b)(1) shall be entitled to all
relief necessary to make the covered individual whole.
(2) Compensatory damages.--Relief for any action described
in paragraph (1) shall include--
(A) reinstatement with the same seniority status that the
covered individual would have had, but for the
discrimination;
(B) the amount of any back pay, with interest; and
(C) compensation for any special damages sustained as a
result of the discrimination, including litigation costs,
expert witness fees, and reasonable attorney's fees.
(d) Rights Retained by the Covered Individual.--Nothing in
this section shall be construed to diminish the rights,
privileges, or remedies of any covered individual under any
Federal or State law, or under any collective bargaining
agreement.

SEC. 408. ADMINISTRATION AND ENFORCEMENT.

(a) In General.--For the efficient administration and
enforcement of the food safety law, the provisions (including
provisions relating to penalties) of sections 6, 8, 9, and 10
of the Federal Trade Commission Act (15 U.S.C. 46, 48, 49,
and 50) (except subsections (c) through (h) of section 6 of
that Act), relating to the jurisdiction, powers, and duties
of the Federal Trade Commission and the Attorney General to
administer and enforce that Act, and to the rights and duties
of persons with respect to whom the powers are exercised,
shall apply to the jurisdiction, powers, and duties of the
Administrator and the Attorney General in administering and
enforcing the provisions of the food safety law and to the
rights and duties of persons with respect to whom the powers
are exercised, respectively.
(b) Inquiries and Actions.--
(1) In general.--The Administrator, in person or by such
agents as the Administrator may designate, may prosecute any
inquiry necessary to carry out the duties of the
Administrator under the food safety law in any part of the
United States.
(2) Powers.--The powers conferred by sections 9 and 10 of
the Federal Trade Commission Act (15 U.S.C. 49 and 50) on the
United States district courts may be exercised for the
purposes of this chapter by any United States district court
of competent jurisdiction.

SEC. 409. CITIZEN CIVIL ACTIONS.

(a) Civil Actions.--A person may commence a civil action
against--
(1) a person that violates a regulation (including a
regulation establishing a performance standard), order, or
other action of the Administrator to ensure the safety of
food; or
(2) the Administrator (in his or her capacity as the
Administrator), if the Administrator fails to perform an act
or duty to ensure the safety of food that is not
discretionary under the food safety law.
(b) Court.--
(1) In general.--The action shall be commenced in the
United States district court for the district in which the
defendant resides, is found, or has an agent.
(2) Jurisdiction.--The court shall have jurisdiction,
without regard to the amount in controversy, or the
citizenship of the parties, to enforce a regulation
(including a regulation establishing a performance standard),
order, or other action of the Administrator, or to order the
Administrator to perform the act or duty.
(3) Damages.--The court may--
(A) award damages, in the amount of damages actually
sustained; and
(B) if the court determines it to be in the interest of
justice, award the plaintiff the costs of suit, including
reasonable attorney's fees, reasonable expert witness fees,
and penalties.
(c) Remedies Not Exclusive.--The remedies provided for in
this section shall be in addition to, and not exclusive of,
other remedies that may be available.

TITLE V--IMPLEMENTATION

SEC. 501. DEFINITION.

For purposes of this title, the term ``transition period''
means the 12-month period beginning on the effective date of
this Act.

SEC. 502. REORGANIZATION PLAN.

(a) Submission of Plan.--Not later than 180 days after the
effective date of this Act, the President shall transmit to
the appropriate congressional committees a reorganization
plan regarding the following:
(1) The transfer of agencies, personnel, assets, and
obligations to the Administration pursuant to this Act.
(2) Any consolidation, reorganization, or streamlining of
agencies transferred to the Administration pursuant to this
Act.
(b) Plan Elements.--The plan transmitted under subsection
(a) shall contain, consistent with this Act, such elements as
the President determines appropriate, including the
following:
(1) Identification of any functions of agencies designated
to be transferred to the Administration pursuant to this Act
that will not be transferred to the Administration under the
plan.
(2) Specification of the steps to be taken by the
Administrator to organize the Administration, including the
delegation or assignment of functions transferred to the
Administration among the officers of the Administration in
order to permit the Administration to carry out the functions
transferred under the plan.
(3) Specification of the funds available to each agency
that will be transferred to the Administration as a result of
transfers under the plan.
(4) Specification of the proposed allocations within the
Administration of unexpended funds transferred in connection
with transfers under the plan.
(5) Specification of any proposed disposition of property,
facilities, contracts, records, and other assets and
obligations of agencies transferred under the plan.
(6) Specification of the proposed allocations within the
Administration of the functions of the agencies and
subdivisions that are not related directly to ensuring the
safety of food.
(c) Modification of Plan.--The President may, on the basis
of consultations with the appropriate congressional
committees, modify, or revise any part of the plan until that
part of the plan becomes effective in accordance with
subsection (d).
(d) Effective Date.--
(1) In general.--The reorganization plan described in this
section, including any modifications or revisions of the plan
under subsection (c), shall become effective for an agency on
the earlier of--
(A) the date specified in the plan (or the plan as modified
pursuant to subsection (c)), except that such date may not be
earlier than 90 days after the date the President has
transmitted the reorganization plan to the appropriate
congressional committees pursuant to subsection (a); or
(B) the end of the transition period.
(2) Statutory construction.--Nothing in this subsection may
be construed to require the transfer of functions, personnel,
records, balances of appropriations, or other assets of an
agency on a single date.
(3) Supercedes existing law.--Paragraph (1) shall apply
notwithstanding section 905(b) of title 5, United States
Code.

SEC. 503. TRANSITIONAL AUTHORITIES.

(a) Provision of Assistance by Officials.--Until the
transfer of an agency to the Administration, any official
having authority over or function relating to the agency
immediately before the effective date of this Act shall
provide the Administrator such assistance, including the use
of personnel and assets, as the Administrator may request in
preparing for the transfer and integration of the agency to
the Administration.
(b) Services and Personnel.--During the transition period,
upon the request of the Administrator, the head of any
executive

[[Page S2111]]

agency may, on a reimbursable basis, provide services or
detail personnel to assist with the transition.
(c) Acting Officials.--
(1) In general.--During the transition period, pending the
advice and consent of the Senate to the appointment of an
officer required by this Act to be appointed by and with such
advice and consent, the President may designate any officer
whose appointment was required to be made by and with such
advice and consent and who was such an officer immediately
before the effective date of this Act (and who continues to
be in office) or immediately before such designation, to act
in such office until the same is filled as provided in this
Act.
(2) Compensation.--While acting pursuant to paragraph (1),
such officers shall receive compensation at the higher of--
(A) the rates provided by this Act for the respective
offices in which they act; or
(B) the rates provided for the offices held at the time of
designation.
(3) Limitation.--Nothing in this Act shall be construed to
require the advice and consent of the Senate to the
appointment by the President to a position in the
Administration of any officer whose agency is transferred to
the Administration pursuant to this Act and whose duties
following such transfer are germane to those performed before
such transfer.
(d) Transfer of Personnel, Assets, Obligations, and
Function.--
(1) In general.--Consistent with section 1531 of title 31,
United States Code, the personnel, assets, liabilities,
contracts, property, records, and unexpended balances of
appropriations, authorizations, allocations, and other funds
that relate to the functions transferred under subsection (a)
from a Federal agency shall be transferred to the
Administration.
(2) Unexpended funds.--Unexpended funds transferred under
this subsection shall be used by the Administration only for
the purposes for which the funds were originally authorized
and appropriated.

SEC. 504. SAVINGS PROVISIONS.

(a) Completed Administrative Actions.--The enactment of
this Act or the transfer of functions under this Act shall
not affect any order, determination, rule, regulation,
permit, personnel action, agreement, grant, contract,
certificate, license, registration, privilege, or other
administrative action issued, made, granted, or otherwise in
effect or final with respect to that agency on the day before
the transfer date with respect to the transferred functions.
(b) Pending Proceedings.--Subject to the authority of the
Administrator under this Act--
(1) pending proceedings in an agency, including notices of
proposed rulemaking, and applications for licenses, permits,
certificates, grants, and financial assistance, shall
continue notwithstanding the enactment of this Act or the
transfer of the agency to the Administration, unless
discontinued or modified under the same terms and conditions
and to the same extent that such discontinuance could have
occurred if such enactment or transfer had not occurred; and
(2) orders issued in such proceedings, and appeals
therefrom, and payments made pursuant to such orders, shall
issue in the same manner on the same terms as if this Act had
not been enacted or the agency had not been transferred, and
any such order shall continue in effect until amended,
modified, superceded, terminated, set aside, or revoked by an
officer of the United States or a court of competent
jurisdiction, or by operation of law.
(c) Pending Civil Actions.--Subject to the authority of the
Administrator under this Act, any civil action commenced with
regard to that agency pending before that agency on the day
before the transfer date with respect to the transferred
functions shall continue notwithstanding the enactment of
this Act or the transfer of an agency to the Administration.
(d) References.--
(1) In general.--After the transfer of functions from a
Federal agency under this Act, any reference in any other
Federal law, Executive order, rule, regulation, directive,
document, or other material to that Federal agency or the
head of that agency in connection with the administration or
enforcement of the food safety laws shall be deemed to be a
reference to the Administration or the Administrator,
respectively.
(2) Statutory reporting requirements.--Statutory reporting
requirements that applied in relation to such an agency
immediately before the effective date of this Act shall
continue to apply following such transfer if they refer to
the agency by name.

SEC. 505. CONFORMING AMENDMENTS.

(a) Executive Schedule.--Section 5313 of title 5, United
States Code, is amended by inserting at the end the following
new item:

``Administrator of Food Safety.''.
(b) Repeal of Certain Provisions.--Section 18 of the
Poultry Products Inspection Act (21 U.S.C. 467), section 401
of the Federal Meat Inspection Act (21 U.S.C. 671), and
section 18 of the Egg Products Inspection Act (21 U.S.C.
1047) are repealed.

SEC. 506. ADDITIONAL TECHNICAL AND CONFORMING AMENDMENTS.

Not later than 60 days after the submission of the
reorganization plan under section 502, the President shall
prepare and submit proposed legislation to Congress
containing necessary and appropriate technical and conforming
amendments to the Acts listed in section 3(15) of this Act to
reflect the changes made by this Act.

SEC. 507. REGULATIONS.

The Administrator may promulgate such regulations as the
Administrator determines are necessary or appropriate to
perform the duties of the Administrator.

SEC. 508. AUTHORIZATION OF APPROPRIATIONS.

There are authorized to be appropriated such sums as are
necessary to carry out this Act.

SEC. 509. LIMITATION ON AUTHORIZATION OF APPROPRIATIONS.

For the fiscal year that includes the effective date of
this Act, the amount authorized to be appropriated to carry
out this Act shall not exceed--
(1) the amount appropriated for that fiscal year for the
Federal agencies identified in section 102(b) for the purpose
of administering or enforcing the food safety law; or
(2) the amount appropriated for those agencies for that
purpose for the preceding fiscal year, if, as of the
effective date of this Act, appropriations for those agencies
for the fiscal year that includes the effective date have not
yet been made.

SEC. 510. EFFECTIVE DATE.

This Act takes effect on the date of enactment of this Act.

____________________