[Congressional Record (Bound Edition), Volume 153 (2007), Part 3]
[Senate]
[Pages 4142-4233]
[From the U.S. 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.
                                 ______
                                 
      By Mr. PRYOR:
  S. 639. A bill to establish digital and wireless networks to advance 
online higher education opportunities for minority students; to the 
Committee on Commerce, Science, and Transportation.
  Mr. PRYOR. Mr. President, I wish to introduce two communications 
bills.

[[Page 4143]]

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.
  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. 602

       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 ``Child Safe Viewing Act of 
     2007''.

     SEC. 2. FINDINGS.

       Congress finds the following:
       (1) Video programming has a direct impact on a child's 
     perception of safe and reasonable behavior.
       (2) Children imitate actions they witness on video 
     programming, including language, drug use, and sexual 
     conduct.
       (3) Studies indicate that the strong appeal of video 
     programming erodes the ability of parents to develop 
     responsible attitudes and behavior in their children.
       (4) The average American child watches 4 hours of 
     television each day.
       (5) Seventy-five percent of adults surveyed believe that 
     television content marketed toward children should be subject 
     to compulsory principles.
       (6) Ninety-nine and nine-tenths percent of all consumer 
     complaints logged by the Federal Communications Commission in 
     the first quarter of 2006 regarding radio and television 
     broadcasting were because of obscenity, indecency, and 
     profanity.
       (7) There is a compelling government interest in empowering 
     parents to limit their children's exposure to harmful 
     television content.
       (8) Section 1 of the Communications Act of 1934 requires 
     the Federal Communications Commission to promote the safety 
     of life and property through the use of wire and radio 
     communications.
       (9) In the Telecommunications Act of 1996, Congress 
     authorized Parental Choice in Television Programming and the 
     V-Chip. Congress further directed action on alternative 
     blocking technology as new video technology advanced.

     SEC. 3. EVALUATION OF ALTERNATIVE PARENTAL CONTROL 
                   TECHNOLOGIES.

       (a) Rulemaking Proceeding Required.--Not later than 120 
     days after the date of enactment of this Act, the Federal 
     Communications Commission shall initiate a proceeding to 
     consider measures to encourage or require the use of advanced 
     blocking technologies that are compatible with various 
     communications devices or platforms.
       (b) Content of Proceeding.--In conducting the proceeding 
     required under subsection (a), the Federal Communications 
     Commission shall consider advanced blocking technologies 
     that--
       (1) may be appropriate across a wide variety of 
     distribution platforms, including wired, wireless, and 
     Internet platforms;
       (2) may be appropriate across a wide variety of devices 
     capable of transmitting or receiving video or audio 
     programming, including television sets, DVD players, VCRs, 
     cable set top boxes, satellite receivers, and wireless 
     devices;
       (3) can filter language based upon information in closed 
     captioning;
       (4) operate independently of ratings pre-assigned by the 
     creator of such video or audio programming; and
       (5) may be effective in enhancing the ability of a parent 
     to protect his or her child from indecent or objectionable 
     programming, as determined by such parent.
       (c) Definition.--In this section, the term ``advanced 
     blocking technologies'' means technologies that can improve 
     or enhance the ability of a parent to protect his or her 
     child from any indecent or objectionable video or audio 
     programming, as determined by such parent, that is 
     transmitted through the use of wire, wireless, or radio 
     communication.
                                  ____


                                 S. 639

       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 ``ED 1.0 Act''.

     SEC. 2. FINDINGS.

       Congress makes the following findings:
       (1) Education is a fundamental right for all Americans, 
     regardless of ethnicity, socio-economic background, or other 
     factors.
       (2) Minority-serving institutions historically have an 
     important role in reaching underserved populations.
       (3) Minority-serving institutions in economically 
     disadvantaged areas face particular hardships in acquiring 
     funds to sustain and expand their resources.
       (4) Low-income areas are technologically underserved.
       (5) Congress and the technological community should do all 
     that they can to find new and creative ways to bridge the 
     current technology gap.

     SEC. 3. DEFINITIONS.

       In this Act:
       (1) Administrator.--The term ``Administrator'' means the 
     Administrator of the National Telecommunications and 
     Information Administration.
       (2) Eligible educational institution.--The term ``eligible 
     educational institution'' means an institution that is--
       (A) a historically Black college or university;
       (B) a Hispanic-serving institution as that term is defined 
     in section 502(a)(5) of the Higher Education Act of 1965 (20 
     U.S.C. 1101a(a)(5));
       (C) a tribally controlled college or university as that 
     term is defined in section 2(a)(4) of the Tribally Controlled 
     College or University Assistance Act of 1978 (25 U.S.C. 
     1801(a)(4));
       (D) an Alaska Native-serving institution as that term is 
     defined in section 317(b)(2) of the Higher Education Act of 
     1965 (20 U.S.C. 1059d(b)(2)); or
       (E) a Native Hawaiian-serving institution as that term is 
     defined in section 317(b)(4) of the Higher Education Act of 
     1965 (20 U.S.C. 1059d(b)(4)).
       (3) Historically black college or university.--The term 
     ``historically Black college or university'' means a part B 
     institution as that term is defined in section 322(2) of the 
     Higher Education Act of 1965 (20 U.S.C. 1061(2)).

     SEC. 4. MINORITY ONLINE DEGREE PILOT PROGRAM.

       (a) Pilot Program Established.--
       (1) In general.--There is established within the National 
     Telecommunications and Information Administration a pilot 
     program to develop online educational programs of study 
     within eligible educational institutions under which the 
     Administrator shall

[[Page 4144]]

     award 4 grants to eligible educational institutions to assist 
     the eligible educational institutions in establishing an 
     online curriculum for undergraduate and graduate programs of 
     study.
       (2) Grant number, duration, and amount.--
       (A) Number.--The Administrator shall award a total of 4 
     grants under this section.
       (B) Duration.--Each grant under this section shall be 
     awarded for a period of 6 years.
       (C) Annual grant payment amounts.--The Administrator shall 
     make grant payments under this section in the amount of--
       (i) $1,000,000 for the first fiscal year of a grant awarded 
     under this section;
       (ii) $600,000 for each of the second through fifth such 
     fiscal years; and
       (iii) $100,000 for the sixth such fiscal year.
       (b) Priority.--
       (1) In general.--In awarding grants under this section the 
     Administrator shall give priority to an eligible educational 
     institution that, according to the most recent data available 
     (including data available from the Bureau of the Census), 
     serves a county--
       (A) in which 50 percent of the residents of the county are 
     members of a racial or ethnic minority;
       (B) in which less than 18 percent of the residents of the 
     county have obtained a baccalaureate degree or a higher 
     education;
       (C) that has an unemployment rate of 7 percent or greater;
       (D) in which 19 percent or more of the residents of the 
     county live in poverty;
       (E) that has a negative population growth rate; or
       (F) that has a median family income of $32,000.
       (2) Highest priority.--In awarding grants under this 
     section the Administrator shall give the highest priority to 
     an eligible educational institution that meets the greatest 
     number of requirements described in subparagraphs (A) through 
     (F) of paragraph (1).
       (c) Use of Funds.--
       (1) Mandatory curriculum requirement.--An eligible 
     educational institution receiving a grant under this section 
     shall use the grant funds to develop a curriculum that--
       (A) leads to a baccalaureate or graduate degree;
       (B) is focused on the needs and interests of working 
     minority students in disadvantaged areas; and
       (C) in the case of an online curriculum, strives to include 
     a mix of--
       (i) online lectures, including guest speakers;
       (ii) reference material;
       (iii) quiz and test preparation; and
       (iv) class room participation.
       (2) Permissive uses.--An eligible educational institution 
     receiving a grant under this section may use the grant 
     funds--
       (A) to assist in establishing the technical capacity of the 
     eligible educational institution to provide online or 
     distance learning; and
       (B) to develop curriculum, including pod broadcasts.
       (3) Limitation on use of funds.--Grant funds made available 
     under this section shall not be used--
       (A) for any purpose other than a purpose associated with 
     the direct costs incurred by the eligible educational 
     institution in developing the curriculum or services 
     described in paragraph (1) or (2); or
       (B) for building expenses, administrative travel budgets, 
     or other expenses that are not directly related to the costs 
     described in subparagraph (A).
       (d) Matching Not Required.--The Administrator shall not 
     require an eligible educational institution to provide 
     matching funds for a grant awarded under this section.
       (e) Report.--
       (1) In general.--Not later than November 1 of each year, 
     the Administrator shall submit to the Committee on Commerce, 
     Science, and Transportation of the Senate and the Committee 
     on Energy and Commerce of the House of Representatives, a 
     report evaluating the progress, during the preceding fiscal 
     year, of the pilot program assisted under this section.
       (2) Contents.--Each report under paragraph (1) shall 
     include a description of each of the programs of study 
     developed with the grant funds provided under this section, 
     including--
       (A) the date of the grant award;
       (B) statistics on the marital status, employment status, 
     and income level of students participating in a program of 
     study assisted under this section; and
       (C) the degree objectives of students participating in a 
     program of study assisted under this section.
       (f) Authorization of Appropriations.--
       (1) In general.--There are authorized to be appropriated to 
     carry out this section--
       (A) $4,500,000 for fiscal year 2008;
       (B) $3,000,000 for each of the fiscal years 2009 through 
     2012; and
       (C) $500,000 for fiscal year 2013.
       (2) Availability.--Funds appropriated under paragraph (1) 
     shall remain available until expended.
       (g) Limitation on Use of Other Funds.--The Administrator 
     shall carry out this section only with amounts appropriated 
     in advance specifically to carry out this section.
                                 ______
                                 
      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 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

[[Page 4145]]

     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 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

[[Page 4146]]

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 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

[[Page 4147]]

     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 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

[[Page 4148]]

     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;
       ``(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

[[Page 4149]]

       ``(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 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.

[[Page 4150]]

  ``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:
       ``(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.

[[Page 4151]]

       ``(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.
       ``(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;

[[Page 4152]]

       ``(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
       ``(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

[[Page 4153]]

     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.
       ``(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

[[Page 4154]]

     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, 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

[[Page 4155]]

     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.
       (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:

[[Page 4156]]

       ``(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.

[[Page 4157]]

       ``(11) Risk-based funding.--The term `risk-based funding' 
     means the allocation of funds based on an assessment of 
     threat, vulnerability, and consequence.
       ``(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

[[Page 4158]]

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 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.

[[Page 4159]]

  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.
  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.

[[Page 4160]]

       ``(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 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

[[Page 4161]]

     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.
       ``(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.

[[Page 4162]]

       (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):
  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.

[[Page 4163]]



     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 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

[[Page 4164]]

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 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.
  Mr. President, to elaborate, 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. 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.

[[Page 4165]]


  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 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

[[Page 4166]]

     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 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

[[Page 4167]]

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):
  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

[[Page 4168]]

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.--
       ``(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;

[[Page 4169]]

       ``(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 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

[[Page 4170]]

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.

     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

[[Page 4171]]

     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 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.

[[Page 4172]]

       (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 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

[[Page 4173]]

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 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.

[[Page 4174]]

  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.
  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 (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

[[Page 4175]]

     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 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

[[Page 4176]]

     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--

       ``(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

[[Page 4177]]

     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 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)''.

  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.

[[Page 4178]]

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.
                                 ______
                                 
      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 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

[[Page 4179]]

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.

[[Page 4180]]

       (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 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.

[[Page 4181]]

       (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.
       (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

[[Page 4182]]

     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.
       ``(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

[[Page 4183]]

     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 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

[[Page 4184]]

     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) 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

[[Page 4185]]

     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 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;

[[Page 4186]]

       ``(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 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

[[Page 4187]]

     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).

     ``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

[[Page 4188]]

     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--
       ``(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

[[Page 4189]]

     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.
       ``(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

[[Page 4190]]

     (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 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

[[Page 4191]]

     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 
     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).

[[Page 4192]]

       ``(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 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,'';

[[Page 4193]]

       (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
       (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

[[Page 4194]]

     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 `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

[[Page 4195]]

     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 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:

[[Page 4196]]



     ``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 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.

[[Page 4197]]

  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.
  Mr. BOND. Mr. President, with more than 100 different forms, 
arthritis is one of the most widespread and devastating health 
conditions in the United States. Nearly 46 million, or one in every 
five, American adults suffer from arthritis or chronic joint symptoms, 
and 300,000 children live with the pain, disability and emotional 
trauma caused by juvenile arthritis.
  As the leading cause of disability in the United States, arthritis is 
a painful and debilitating chronic disease affecting men, women and 
children alike. This is why the Federal Government must make a stronger 
investment in research, treatment and prevention of arthritis.
  We know that early diagnosis, treatment, and appropriate management 
of arthritis can control symptoms and improve quality of life. The 
Arthritis Prevention, Control and Cure Act will expand the Federal 
Government's efforts to find new ways to prevent, treat, and care for 
patients with arthritis and related rheumatic diseases by: (1) 
improving coordination among Federal agencies and the public with 
regard to the Federal investment in arthritis research and public 
health activities through a National Arthritis and Rheumatic Diseases 
Summit; (2) accelerating research that will lead to improved treatments 
and a cure for juvenile arthritis; (3) investing in a nationwide public 
health initiative designed to reduce the pain and disability of 
arthritis through early diagnosis and effective treatment of the 
disease; and (4) ensuring kids with arthritis have access to specialty 
care by addressing the nationwide shortage of pediatric 
rheumatologists.
  We have a responsibility to look for solutions to this issue in a 
comprehensive manner. I look forward to working with Senator Kennedy on 
this important legislation which will make a real difference in the 
lives of the millions of Americans, both young and old, who suffer from 
this debilitating disease.
                                 ______
                                 
      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 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

[[Page 4198]]

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.
       (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.

[[Page 4199]]

       (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 4200]]

       (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.

[[Page 4201]]

       (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 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.

[[Page 4202]]

     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.
       (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

[[Page 4203]]

       (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.
       (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

[[Page 4204]]

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.
  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;

[[Page 4205]]

       ``(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 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

[[Page 4206]]

     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--
       ``(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.

[[Page 4207]]

  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 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.

[[Page 4208]]


  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 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

[[Page 4209]]

     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 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

[[Page 4210]]

     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 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.

[[Page 4211]]

  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 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

[[Page 4212]]

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.
  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

[[Page 4213]]

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.

     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,

[[Page 4214]]

     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.).

     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.

[[Page 4215]]

       (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.

     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;

[[Page 4216]]

       (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.

     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--

[[Page 4217]]

       (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
       (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--

[[Page 4218]]

       (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.

 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

[[Page 4219]]

     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.

     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.

[[Page 4220]]

       (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 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.

[[Page 4221]]

       (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 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.

[[Page 4222]]

       (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 
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

[[Page 4223]]

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.
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

[[Page 4224]]

     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.);
       (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)).

[[Page 4225]]

       (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;
       (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

[[Page 4226]]

     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 
     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

[[Page 4227]]

       (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 4228]]

       (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

[[Page 4229]]

     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.--
       (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

[[Page 4230]]

     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;
       (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

[[Page 4231]]

     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--
       (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)

[[Page 4232]]

     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.

     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.

[[Page 4233]]

       (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 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.

                          ____________________