[Congressional Record Volume 161, Number 14 (Wednesday, January 28, 2015)]
[Senate]
[Pages S591-S603]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS
By Mr. BARRASSO (for himself, Mr. Tester, and Ms. Murkowski):
S. 286. A bill to amend the Indian Self-Determination and Education
Assistance Act to provide further self-governance by Indian tribes, and
for other purposes; to the Committee on Indian Affairs.
Mr. BARRASSO. Mr. President, I rise today to introduce legislation
that would further advance the goals of Indian self-governance and
self-determination. The legislation is entitled, the Department of the
Interior Self-Governance Act of 2015. I thank my colleagues who have
joined me as original cosponsors of this legislation, including Indian
Affairs Committee Vice Chairman Senator Tester and Senator Murkowski.
One of the cornerstones of Federal Indian policy is the concept of
tribal self-determination and self-governance. In 1975, Congress passed
the Indian Self-Determination and Education Assistance Act. The Act,
Public Law No. 93-638 authorizes Indian tribes to carry out certain
Federal Indian programs, activities, and functions within the
Department of the Interior and the Department of the Health and Human
Services.
Self-governance is both a policy and procedure whereby, pursuant to
the Indian Self-Determination and Education Assistance Act, Indian
tribes administer Federal programs for Indians. Tribal administration
of these programs promotes local control and decision-making for these
important programs that affect the local tribal community.
Tribal administration through these processes also serves to reduce
Federal bureaucracy. This legislation promotes accountability by
maintaining requirements that Indian tribes must demonstrate a higher
level of responsible governance and administration. Good governance is
vital for continuing this policy.
The act gives authority to the Secretaries of the Interior and Health
and Human Services to enter into 638 contracts and self-governance
compacts with Indian tribes. Each 638 contact or self-governance
compact identifies functions and activities to be carried out by the
tribe, as well as any administrative, reporting, or other requirements
that must be followed.
Despite the increased flexibility in the tribal self-governance
program, Indian tribes have stated to Congress that the Department of
the Interior has, for many years, resisted the efforts by tribes to
carry out Interior programs. Without additional reforms, the success of
the Indian Self-Determination and Education Assistance Act cannot reach
its full potential.
The bill intends to clarify and expand the provisions of the Indian
Self-Determination and Education Assistance Act. This legislation will
give tribes a better opportunity to advance the policy of tribal self-
governance by authorizing the Secretary of the Interior to select up to
50 new Indian tribes to participate in the tribal self-governance
program. In addition, the bill clarifies that provisions of water
settlements and their authorizing legislation will not be affected by
the self-governance amendments. Furthermore, nothing in this will
expand or limit programs eligible for self-governance compacts beyond
those already authorized under current law.
This bipartisan bill is supported by Indian tribes across the
country. I urge my colleagues to support this legislation.
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By Mr. DURBIN (for himself, Mrs. Feinstein, Mrs. Gillibrand, and
Mr. Blumenthal):
S. 287. A bill to establish the Food Safety Administration to protect
the public health by preventing foodborne illness, ensuring the safety
of food, improving research on contaminants leading to foodborne
illness, and improving security of food from international
contamination, and for other purposes; to the Committee on Agriculture,
Nutrition, and Forestry.
Mr. DURBIN. 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. 287
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 2015''.
(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 facilities.
Sec. 203. Preventive process controls to reduce adulteration of food.
Sec. 204. Performance standards for contaminants in food.
Sec. 205. Inspections of food facilities.
Sec. 206. Food production establishments.
Sec. 207. Federal and State cooperation.
Sec. 208. Foreign supplier verification program.
Sec. 209. Imports.
Sec. 210. Traceback.
Sec. 211. Food safety technology.
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. Mandatory recall authority.
Sec. 403. Injunction proceedings.
Sec. 404. Civil and criminal penalties.
Sec. 405. Presumption.
Sec. 406. Whistleblower protection.
Sec. 407. Administration and enforcement.
Sec. 408. Citizen civil actions.
TITLE V--IMPLEMENTATION
Sec. 501. Definition.
Sec. 502. Reorganization plan.
Sec. 503. Transitional authorities.
Sec. 504. Savings provisions.
Sec. 505. Conforming amendments.
Sec. 506. Additional technical and conforming amendments.
Sec. 507. Regulations.
Sec. 508. Authorization of appropriations.
Sec. 509. Limitation on authorization of appropriations.
Sec. 510. Effective date.
SEC. 2. FINDINGS; PURPOSES.
(a) Findings.--Congress finds that--
(1) the safety of the food supply of the United States is
vital to the public health, to public confidence in the food
supply, and to the success of the food sector of the Nation's
economy;
(2) lapses in the protection of the food supply and loss of
public confidence in food safety are damaging to consumers
and the food industry, and place a burden on interstate
commerce;
(3) the safety and security of the food supply requires an
integrated, systemwide approach to preventing foodborne
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 foodborne
illnesses, including infants and children;
(C) a concern regarding food fraud for economic gain,
especially with mislabeling and intentionally misleading
claims;
(D) an increasing volume of imported food, without adequate
monitoring and inspection; and
(E) 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 foodborne illness;
(6) the Federal food safety system is fragmented, with at
least 15 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 foodborne illness;
(7) the fragmented Federal food safety system and outdated
laws preclude an integrated, systemwide approach to
preventing foodborne 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 related labeling to strengthen
the protection of the public health;
(B) ensure that food facilities 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, systemwide approach to food safety
and to make more effective and efficient use of resources to
prevent foodborne 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 foodborne 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
given such term in--
(i) section 402 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 342) for food regulated under such Act;
(ii) section 1(m) of the Federal Meat Inspection Act (21
U.S.C. 601(m)) for food regulated under such Act;
(iii) section 4(g) of the Poultry Products Inspection Act
(21 U.S.C. 453(g)) for food regulated under such Act; and
(iv) section 4(a) of the Egg Products Inspection Act (21
U.S.C. 1033(a)) for food regulated under such Act.
(B) Inclusion.--In applying the definitions cited in
subparagraph (A), poisonous or deleterious substances in food
shall be treated as an added substance if the poisonous or
deleterious substances are known to cause serious illness or
death in persons, including in 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 facility.--The term ``category 1 food
facility'' means a facility that slaughters animals for food.
(6) Category 2 food facility.--The term ``category 2 food
facility'' means a facility that processes--
(A) raw meat, poultry, or seafood in a manner that may
reduce but is not validated to destroy contaminants; or
(B) other products that the Administrator determines by
regulation to be at high risk of contamination.
(7) Category 3 food facility.--The term ``category 3 food
facility'' means a facility--
(A) that processes meat, poultry, or seafood, or other
products that the Administrator determines by regulation to
be at high risk of contamination; and
(B) whose processes include one or more steps validated to
destroy contaminants.
(8) Category 4 food facility.--The term ``category 4 food
facility'' means a facility that processes food but is not a
category 1, 2, or 3 food facility.
(9) Category 5 food facility.--The term ``category 5 food
facility'' means a facility that stores, holds, or transports
food prior to delivery for retail sale.
[[Page S593]]
(10) Contaminant.--The term ``contaminant'' includes
biological, chemical, physical, or radiological hazards,
natural toxins, pesticides, drug residues, decomposition,
parasites, allergens, and unapproved food or color additives.
(11) Contamination.--The term ``contamination'' refers to a
presence of a contaminant in food, which may occur naturally
or be introduced into a food.
(12) Feed facility.--The term ``feed facility'' means a
domestic or foreign feed manufacturer, processor, packer,
warehouse, or other facility that--
(A) if operating in the United States, manufactures,
slaughters, processes, or holds animal feed or feed
ingredients; or
(B) if operating elsewhere, manufactures, slaughters,
processes, or holds animal feed or feed ingredients intended
for consumption in the United States.
(13) 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 and animal food that is made in whole or in
part from any animal, including cattle, sheep, swine, goat,
or poultry (as defined in section 4 of the Poultry Products
Inspection Act (21 U.S.C. 453)), and animal feed.
(14) Food facility.--
(A) In general.--The term ``food facility'' means a
domestic or foreign food manufacturer, slaughterhouse,
processor, packer, warehouse, or other facility that--
(i) if operating in the United States, manufactures,
slaughters, processes, or holds food or food ingredients; or
(ii) if operating outside the United States, manufactures,
slaughters, processes, or holds food intended for consumption
in the United States.
(B) Exclusions.--For the purposes of registration, the term
``food facility'' does not include--
(i) a farm, restaurant, other retail food establishment,
nonprofit food establishment in which food is prepared for or
served directly to the consumer; or
(ii) a fishing vessel (other than a fishing vessel engaged
in processing, as that term is defined in section 123.3(k) of
title 21, Code of Federal Regulations).
(15) Food production establishment.--The term ``food
production establishment'' means any farm, ranch, orchard,
vineyard, aquaculture facility, or confined animal-feeding
operation.
(16) 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 FDA Food Safety Modernization Act (Public Law 111-
353);
(F) the Egg Products Inspection Act (21 U.S.C. 1031 et
seq.);
(G) the Sanitary Food Transportation Act of 1990 (49 U.S.C.
App. 2801 et seq.);
(H) chapter 57 of title 49, United States Code;
(I) Public Law 85-765 (commonly known as the ``Humane
Methods of Slaughter Act of 1958'') (7 U.S.C. 1901 et seq.);
(J) the provisions of this Act; and
(K) 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.
(17) Interstate commerce.--The term ``interstate commerce''
has the meaning given that term in section 201(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(b)).
(18) Misbranded.--The term ``misbranded'' has the meaning
given to it in--
(A) section 403 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 343) for food regulated under such Act;
(B) section 1(n) of the Federal Meat Inspection Act (21
U.S.C. 601(n)) for food regulated under such Act;
(C) section 4(h) of the Poultry Products Inspection Act (21
U.S.C. 453(h)) for food regulated under such Act; and
(D) section 4(l) of the Egg Products Inspection Act (21
U.S.C. 1033(l)) for food regulated under such Act.
(19) Process.--The term ``process'' or ``processing'' means
the commercial 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 act of
obtaining evidence that the process control measure or
measures selected to control a contaminant in food is capable
of effectively and consistently controlling the contaminant.
(23) Statistically valid.--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,
labeling, 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 benefit in reducing foodborne illness;
(E) coordination of the Federal response to foodborne
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 and feed
facilities and imports;
(5) the Center for Veterinary Medicine of the Food and Drug
Administration;
(6) the resources and facilities of the Office of the
Commissioner of the Food and Drug Administration, known as
the Office of Food and Veterinary Medicine, 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);
(7) the part of the Research, Education, and Economics
mission area of the Department of Agriculture related to food
and feed safety;
(8) 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;
(9) the part of the Animal and Plant Inspection Health
Service of the Department of Agriculture related to the
management of animals going into the food supply; and
(10) 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
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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 regulatory
science and 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 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 manage and 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 facilities and regular unannounced
inspection of food facilities;
(2) verify and enforce the adoption of preventive process
controls in food facilities, based on the 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 performance 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) access the surveillance data of the Centers for Disease
Control and Prevention, and other Federal Government
agencies, in order to develop and 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) partner with relevant agencies to identify and prevent
terrorist threats to food;
(9) establish a process for providing a single point of
contact to assist impacted consumers in navigating Federal,
State, and local agencies involved in responding to or
monitoring a foodborne outbreak;
(10) develop public education risk communication and
advisory programs;
(11) implement a basic and applied research program to
further the purposes of this Act; and
(12) coordinate and prioritize food safety research and
educational programs with other agencies, including State or
local agencies.
SEC. 202. REGISTRATION OF FOOD FACILITIES.
(a) In General.--The Administrator shall require that all
food and feed facilities register before the facility can
operate in the United States or import food, feed, or
ingredients into the United States.
(b) Registration Requirements.--
(1) In general.--To be registered under subsection (a)--
(A) all food facilities covered under this Act shall comply
with registration requirements in section 415 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 350d);
(B) for food facilities that have not registered under such
section 415 prior to the date of enactment of this Act, the
requirement in subparagraph (A) applies beginning on the day
that is 180 days after the date of enactment of this Act; and
(C) for food facilities that have registered under such
section 415 prior to the date of enactment of this Act, such
facilities shall file an amended registration within 180 days
of such date of enactment to deliver the information required
by paragraph (2).
(2) Categories.--In addition to the information required
under section 415 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 350d) to be included in registration, a food
facility shall--
(A) list the facility's primary purpose and business
activity, including the dates of operation if the food
facility is operating seasonally; and
(B) list the types of food handled at the facility and
identify the activities conducted in the facility, that are
relevant to determining whether the facility is a category 1,
2, 3, 4, or 5 facility.
(3) Procedure.--Upon receipt of a completed or amended
registration described in paragraph (1), the Administrator
shall notify the registrant of the receipt of the
registration, review the activities identified in the
registration, designate the facility as a category 1, 2, 3,
4, or 5 food facility for the purposes of inspection, and
assign a registration number to each food facility.
(4) List.--The Administrator--
(A) shall compile and maintain an up-to-date list of food
facilities that are registered under this section, in
accordance with section 415(a)(5) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 350d(a)(5)); and
(B) may establish regulations on how the list may be shared
with other governmental authorities.
SEC. 203. PREVENTIVE PROCESS CONTROLS TO REDUCE ADULTERATION
OF FOOD.
(a) In General.--The Administrator shall review existing
regulations on hazard analysis and process controls and amend
existing regulations as appropriate, upon the basis of best
available public health, scientific, and technological
information, to ensure that those regulations are working
effectively to--
(1) ensure food facilities operate in a sanitary manner so
that food is not adulterated;
(2) limit the presence of contaminants in food;
(3) meet the performance standards established under
section 204;
(4) ensure fully processed or ready-to-eat foods are
processed using reasonably available techniques and
technologies to eliminate contaminants;
(5) label food intended for final processing outside
commercial food facilities with instructions for handling and
preparation for consumption that will destroy contaminants;
(6) 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 performance standards
are being met; and
(7) provide for agency access to records kept by food
facilities and submission of copies of the records to the
Administrator, as the Administrator determines appropriate.
(b) 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) Performance Standards.--Whenever the Administrator
determines that a foodborne contaminant presents the risk of
serious adverse health consequences or death to consumers,
causes food to be adulterated, or could promote the spread of
communicable disease described in section 361 of the Public
Health Service Act (42 U.S.C. 264), the Administrator shall
issue a performance standard (in the form of guidance, action
levels, or regulations) to prevent or control the
contaminant.
(b) 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 facilities are
complying with the standards promulgated under this section.
(2) Actions.--If the Administrator determines that a food
facility fails to meet a standard promulgated under this
section, and such facility 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 facility
under section 209(i);
(B) order a recall of food from the food facility under
section 402;
(C) increase the inspection frequency for the food
facility;
(D) withdraw the mark of inspection from the food facility,
if in use; or
(E) take other appropriate enforcement action concerning
the food facility, including suspension of registration.
(c) 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.
(d) Revocation by Administrator.--All performance
standards, tolerances, action levels, or other similar
standards with respect to food in effect on the date of
enactment of this Act shall remain in effect until revised or
revoked by the Administrator.
SEC. 205. INSPECTIONS OF FOOD FACILITIES.
(a) In General.--The Administrator shall establish an
inspection program, which shall include sampling and testing
of food and food facilities, to determine if each food
facility--
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(1) is operating in a sanitary manner;
(2) has continuous systems, interventions, and processes in
place to minimize or eliminate contaminants in food;
(3) uses validated process controls and ongoing
verification;
(4) is in compliance with applicable performance standards
established under section 204, process control regulations,
and other requirements;
(5) is processing food that is safe and not adulterated or
misbranded;
(6) maintains records of process control plans under
section 203, and other records related to the processing,
sampling, and handling of food; and
(7) is in compliance with the requirements of the
applicable food safety law.
(b) Facility Categories and Inspection Frequencies.--
Inspections of food facilities under this Act shall be based
on the following categories and inspection frequencies,
subject to subsections (c), (d), and (e):
(1) Category 1 food facilities.--A category 1 food facility
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 facility has successfully identified and
removed from the slaughter line visibly defective or
contaminated carcasses, has avoided cross-contamination, and
destroyed or reprocessed contaminated carcasses 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 facilities.--A category 2 food facility
shall be randomly inspected at least daily.
(3) Category 3 food facilities.--A category 3 food facility
shall--
(A) provide documentation to the Administrator on request
that ongoing verification shows that its processes are
controlled; and
(B) be randomly inspected at least monthly.
(4) Category 4 food facilities.--A category 4 food facility
shall be randomly inspected at least quarterly.
(5) Category 5 food facilities.--A category 5 food facility
shall be randomly inspected at least annually.
(c) Establishment of Inspection Procedures.--The
Administrator shall establish procedures under which
inspectors or safety officers inspect food facilities, which
shall allow the taking of random samples, photographs, and
copies of records in food facilities.
(d) Alternative Inspection Frequencies.--With respect to a
category 2, 3, 4, or 5 food facility, the Administrator may
establish alternative increased or decreased inspection
frequencies for subcategories of food facilities or for
individual facilities, to foster risk-based allocation of
resources, subject to the following criteria and procedures:
(1) Subcategories of food facilities and their alternative
inspection frequencies shall be defined by regulation,
subject to paragraphs (2) and (3).
(2) Alternative inspection frequencies for subcategories of
food facilities under paragraph (1) and for a specific food
facility under paragraph (4) shall provide that--
(A) category 2 food facilities shall be inspected at least
monthly; and
(B) category 3 and 4 food facilities shall be inspected at
least annually.
(3) In defining subcategories of food facilities and their
alternative inspection frequencies under paragraphs (1) and
(2), the Administrator shall consider--
(A) the nature of the foods being processed, stored, or
transported;
(B) the manner in which foods are processed, stored, or
transported;
(C) the inherent likelihood that the foods will contribute
to the risk of foodborne illness;
(D) the best available evidence concerning reported
illnesses associated with the foods produced in the proposed
subcategory of facilities; and
(E) the overall record of compliance with the food safety
law among facilities 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 facility, subject to paragraphs (2) and (5), and
shall annually publish a list of facilities subject to
alternative inspections.
(5) In adopting alternative inspection frequencies for a
specific facility, the Administrator shall consider--
(A) the supporting evidence that an individual food
facility shall submit related to whether an alternative
inspection frequency should be established for such facility
by the Administrator;
(B) whether products from the specific facility have been
associated with a case or an outbreak of foodborne illness;
(C) the record of the facility of compliance with the food
safety law, including compliance with applicable performance
standards and the frequency of recalls; and
(D) the criteria in paragraph (3).
(6) Before establishing decreased alternative inspection
frequencies for subcategories of facilities or individual
facilities, the Administrator shall--
(A) describe the alternative uses of resources in general
terms when issuing the regulation or order that establishes
the alternative inspection frequency; and
(B) 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
foodborne illness.
(e) Inspection Transition.--The Administrator shall manage
the transition to the inspection system described in this Act
as follows:
(1) Regulations.--The Administrator shall promulgate
regulations to implement this section no later than 24 months
after the date of enactment of this Act.
(2) Limit on reduction in inspection frequency.--For any
food facility, the Administrator shall not reduce the
inspection frequency from the frequency required pursuant to
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 the food facility has demonstrated 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.
(f) Official Mark.--
(1) In general.--
(A) Establishment.--Before the completion of the transition
process under subsection (e), the Administrator shall by
regulation establish an official mark that can be affixed to
a food produced in a category 1, 2, or 3 food facility if--
(i) the facility is in compliance with the food safety law;
and
(ii) has been inspected in accordance with the inspection
frequencies under this section.
(B) Removal of official mark.--The Administrator shall
promulgate regulations that provide for the removal of the
official mark under this subsection if--
(i) the Administrator makes a finding that the facility is
not in compliance with the food safety law; or
(ii) the Administrator suspends the registration of the
facility.
(2) Category 1, 2, or 3 food facilities.--In the case of
products manufactured, slaughtered, processed, or held in a
category 1, 2, or 3 food facility--
(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
subsection (e);
(B) the Administrator shall publicly certify on a monthly
basis that the inspection frequencies required under this
section have been achieved; and
(C) a product from an facility 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 facilities.--In the case of a
product manufactured, slaughtered, processed, or held in a
category 4 or 5 food facility, 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 as the Administrator considers
appropriate.
(g) Maintenance and Inspection of Records.--
(1) In general.--
(A) Records.--A food facility shall--
(i) maintain such records as the Administrator requires 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 facility
representative in any format (including paper or electronic)
and at any location, that are necessary to assist the
Administrator to determine whether the food is contaminated
or not in compliance with the food safety law.
(B) Required disclosure.--A food facility 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 required by
paragraph (1) shall be maintained for a reasonable period of
time, as determined by the Administrator.
(3) Requirements.--The records required by paragraph (1)
shall include records describing--
[[Page S596]]
(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 facility;
(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.
(h) 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 facility 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 402; or
(E) limit the authority of the Administrator to promulgate
regulations to permit the sharing of data with other
governmental authorities.
(i) 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 ESTABLISHMENTS.
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 establishments,
to--
(1) visit and inspect food production establishments in the
United States and in foreign countries for food safety
purposes;
(2) review food safety records as needed to carry out
traceback and for other food safety purposes;
(3) set good practice standards to protect the public and
promote food safety;
(4) partner with appropriate agencies to monitor 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 to a State--
(1) advisory assistance;
(2) technical and laboratory assistance and training
(including necessary materials and equipment); and
(3) financial assistance, 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. FOREIGN SUPPLIER VERIFICATION PROGRAM.
(a) In General.--The Administrator shall require that each
importer of products from a feed facility, food facility, or
food producer establishment be in compliance with the foreign
supplier verification program requirements under section 805
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384a).
(b) Rule of Construction.--In applying subsection (a) with
respect to products subject to the Federal Meat Inspection
Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection
Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection
Act (21 U.S.C. 1031 et seq.), references in section 805 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384a) to
sections 402, 403(w), 418, and 419 of such Act (21 U.S.C.
342, 343(w), 350g, and 350h) shall be construed to be
references to the corresponding provisions of the food safety
law, if any, that apply to such products, as determined by
the Administrator.
(c) Repeal of Exemptions.--Subsection (e) of section 805 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384a) is
hereby repealed.
SEC. 209. 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 seeking to certify food for
importation into the United States shall submit a request for
accreditation to the Administrator.
(b) Accreditation Standard.--A foreign government
requesting to be accredited to certify food for importation
into the United States shall demonstrate, in a manner
determined appropriate by the Administrator, that the foreign
government (or an agency thereof) is capable of adequately
ensuring that eligible entities or foods certified by such
government (or agency) meet the requirements of the food
safety law.
(c) Request by Foreign Government.--Prior to granting
accreditation to a foreign government under this section, the
Administrator shall review and audit the food safety program
of the requesting foreign government and certify that such
program (including all statutes, regulations, and inspection
authority) meets the standard specified in subsection (b).
(d) Limitations.--Any accreditation of a foreign government
under this section shall--
(1) specify the foods covered by the accreditation; and
(2) be limited to a period not to exceed 5 years.
(e) Withdrawal of Accreditation.--The Administrator may
withdraw accreditation fully or partially from a foreign
government if the Administrator finds that--
(1) food covered by the accreditation is linked to an
outbreak of human illness;
(2) the programs or procedures of the foreign government no
longer meet the standards of the food safety programs and
procedures of the United States; or
(3) the foreign government refuses 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 Accreditation.--The Administrator shall
audit foreign governments accredited under this section at
least every 5 years to ensure the continued compliance by
such governments with the standard set forth in subsection
(b).
(g) Required Routine Inspection.--The Administrator shall
routinely inspect food or food animals by physical
examination before the food or food animals enter the United
States to ensure that the food or food animals--
(1) are safe;
(2) are labeled as required for food produced in the United
States; and
(3) otherwise meet the requirements of the food safety law.
(h) Enforcement.--The Administrator may--
(1) deny importation of food from any country if the
country's government does not permit United States officials
to enter the 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 country or foreign
facility that does not consent to an investigation by the
Administrator when food from that country or foreign facility
is linked to a foodborne illness outbreak or is otherwise
found to be adulterated or mislabeled; and
(3) promulgate 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
the food safety law.
(i) Detention and Seizure.--Any food imported for
consumption in the United States that fails to meet the
standards of the food safety law may be detained, seized, or
condemned.
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, animals, or ingredients 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
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(2) apply to food production establishments and food
facilities.
SEC. 211. FOOD SAFETY TECHNOLOGY.
(a) In General.--The Administrator shall establish and
implement a program, to be known as the Food Safety
Technology Program, to foster innovation in food technologies
and foods that have the potential to improve food safety at
the point of production, processing, transport, storage, or
final preparation.
(b) Program Described.--The program under this section
shall consist of technical guidance to and consultation with
technology developers to assist them in meeting requirements
for approval of technologies and products described in
subsection (a).
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) partner with relevant agencies to maintain or access an
active surveillance system of food 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) partner with relevant agencies to maintain or access a
state-of-the-art partial or full genome sequencing system and
epidemiological system dedicated to foodborne 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.--Through the surveillance
system referred to in subsection (a), the sampling system
described in subsection (b), and other available data, the
Administrator shall--
(1) rank food categories based on the hazard to human
health presented by the food category;
(2) identify appropriate industry and regulatory approaches
to minimize hazards in the food supply; and
(3) assess the public health environment for emerging
diseases, including zoonosis, for their risk of appearance in
the United States food supply.
SEC. 302. PUBLIC EDUCATION AND ADVISORY SYSTEM.
(a) Public Education.--The Administrator shall--
(1) in cooperation with private and public organizations,
including the cooperative extension services and building on
the efforts of appropriate State and local entities,
establish a national public education program on food safety;
and
(2) coordinate with other Federal departments and agencies
to integrate food safety messaging into all food-related
agricultural, nutrition, and health promotion programs.
(b) Health Advisories.--The Administrator, in consultation
with such 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) determine the food safety education needs of vulnerable
populations, including children less than 10 years of age,
pregnant women, adults 65 years of age and older, and
individuals with compromised immune systems;
(9) utilize the partial or full genome sequencing system
and other processes to identify and control pathogens;
(10) address common and emerging zoonotic diseases;
(11) develop methods to reduce or destroy harmful pathogens
before, during, and after processing;
(12) analyze the incidence of antibiotic resistance as it
pertains to the food supply and develop new methods to reduce
infection by antibiotic resistant bacteria in humans and
animals; and
(13) 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 facility or foreign food facility to fail to
register under section 202, or to operate without a valid
registration;
(4) to refuse to permit access to a food facility for the
inspection and copying of a record as required under section
205(g);
(5) to fail to establish or maintain any record or to make
any report as required under section 205(g);
(6) to refuse to permit entry to or inspection of a food
facility 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(g)(1)(B);
(8) to fail to comply with an applicable provision of, or a
regulation or order of the Administrator under, section 202,
204, or 208;
(9) to slaughter an animal that is capable for use in whole
or in part as human food at a food facility processing any
such food for commerce, except in compliance with the food
safety law;
(10) to fail to comply with a recall or other order under
section 402; or
(11) to otherwise violate the food safety law.
SEC. 402. MANDATORY RECALL AUTHORITY.
(a) Voluntary Procedures.--If the Administrator determines
that there is a reasonable probability that an article of
food (other than infant formula) is adulterated or misbranded
and the use of or exposure to such article will cause serious
adverse health consequences or death to humans or animals,
the Administrator shall provide the owner, operator, or agent
in charge of the facility that created, caused, or was
otherwise responsible for such food with an opportunity to
cease distribution and recall such article.
(b) Prehearing Order to Cease Distribution and Give
Notice.--
(1) In general.--If the owner, operator, or agent in charge
of the facility refuses to or does not voluntarily cease
distribution or recall such article within the time and in
the manner prescribed by the Administrator (if so
prescribed), the Administrator may by order require, as the
Administrator deems necessary, such person to--
(A) immediately cease distribution of such article;
(B) as applicable, immediately notify all persons
manufacturing, processing, packing, transporting,
distributing, receiving, holding, or importing and selling
such article; and
(C) to which such article has been distributed,
transported, or sold, immediately cease distribution of such
article.
(2) Required additional information.--
(A) In general.--If an article of food covered by a recall
order issued under paragraph (1)(B) has been distributed to a
warehouse-based, third-party logistics provider without
providing such provider sufficient information to know or
reasonably determine the precise identity of the article of
food covered by a recall order that is in its possession, the
notice provided by the responsible party subject to the order
issued under paragraph (1)(B) shall include such information
as is necessary for the warehouse-based, third-party
logistics provider to identify the food.
(B) Rules of construction.--Nothing in this paragraph shall
be construed--
(i) to exempt a warehouse-based, third-party logistics
provider from the requirements of food safety law; or
(ii) to exempt a warehouse-based, third-party logistics
provider from being the subject of a mandatory recall order.
(3) Determination to limit areas affected.--If the
Administrator requires an owner, operator, or agent in charge
of the facility to cease distribution under paragraph (1)(A)
of an article of food identified in subsection (a), the
Administrator may limit the size of the geographic area and
the markets
[[Page S598]]
affected by such cessation if such limitation would not
compromise the public health.
(c) Hearing on Order.--The Administrator shall provide the
owner, operator, or agent in charge of the facility subject
to an order under subsection (b) with an opportunity for an
informal hearing, to be held as soon as possible, but not
later than 2 days after the issuance of the order, on the
actions required by the order and on why the article that is
the subject of the order should not be recalled.
(d) Post-hearing Recall Order and Modification of Order.--
(1) Amendment of order.--If, after providing opportunity
for an informal hearing under subsection (c), the
Administrator determines that removal of the article from
commerce is necessary, the Administrator shall, as
appropriate--
(A) amend the order to require recall of such article 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 to consumers to whom such article was,
or may have been, distributed.
(2) Vacating of order.--If, after such hearing, the
Administrator determines that adequate grounds do not exist
to continue the actions required by the order, or that such
actions should be modified, the Administrator shall vacate
the order or modify the order.
(e) Rule Regarding Alcoholic Beverages.--The Administrator
shall not initiate a mandatory recall or take any other
action under this section with respect to any alcohol
beverage until the Administrator has provided the Alcohol and
Tobacco Tax and Trade Bureau with a reasonable opportunity to
cease distribution and recall such article under the Alcohol
and Tobacco Tax and Trade Bureau's authority.
(f) Cooperation and Consultation.--The Administrator shall
work with State and local public health officials in carrying
out this section, as appropriate.
(g) Public Notification.--In conducting a recall under this
section, the Administrator shall--
(1) ensure that a press release is published regarding the
recall, as well as alerts and public notices, as appropriate,
in order to provide notification--
(A) of the recall to consumers and retailers to whom such
article was, or may have been, distributed; and
(B) that includes, at a minimum--
(i) the name of the article of food subject to the recall;
(ii) a description of the risk associated with such
article; and
(iii) to the extent practicable, information for consumers
about similar articles of food that are not affected by the
recall;
(2) provide to the public a list of retail consignees
receiving products for which there is determined to be a
reasonable probability that eating the food will cause
serious adverse health consequences or death to humans or
animals; and
(3) if available, publish on the Internet website of the
Administration an image of the article that is the subject of
the press release described in paragraph (1).
(h) No Delegation.--The authority conferred by this section
to order a recall or vacate a recall order shall not be
delegated to any officer or employee other than the
Administrator.
(i) Effect.--Nothing in this section shall affect the
authority of the Administrator to request or participate in a
voluntary recall, or to issue an order to cease distribution
or to recall under any other provision of the food safety law
or under the Public Health Service Act (42 U.S.C. 201 et
seq.).
(j) Coordinated Communication.--
(1) In general.--To assist in carrying out the requirements
of this subsection, the Administrator shall establish an
incident command operation or a similar operation that will
operate not later than 24 hours after the initiation of a
mandatory recall or the recall of an article of food for
which the use of, or exposure to, such article will cause
serious adverse health consequences or death to humans or
animals.
(2) Requirements.--To reduce the potential for
miscommunication during recalls or regarding investigations
of a foodborne illness outbreak associated with a food that
is subject to a recall, each incident command operation or
similar operation under paragraph (1) shall use regular staff
and resources of the Administration to--
(A) ensure timely and coordinated communication within the
Administration, including enhanced communication and
coordination between different agencies and organizations
within the Administration;
(B) ensure timely and coordinated communication from the
Administration, including public statements, throughout the
duration of the investigation and related foodborne illness
outbreak;
(C) identify a single point of contact within the
Administration for public inquiries regarding any actions by
the Administrator related to a recall;
(D) coordinate with Federal, State, local, and tribal
authorities, as appropriate, that have responsibilities
related to the recall of a food or a foodborne illness
outbreak associated with a food that is subject to the
recall, including notification of the Secretary of
Agriculture and the Secretary of Education in the event such
recalled food is a commodity intended for use in a child
nutrition program (as defined in section 25(b) of the Richard
B. Russell National School Lunch Act (42 U.S.C. 1769f(b)));
and
(E) conclude operations at such time as the Administrator
determines appropriate.
(3) Multiple recalls.--The Administrator may establish
multiple or concurrent incident command operations or similar
operations in the event of multiple recalls or foodborne
illness outbreaks.
(4) Fees applicable to all facilities.--Fees described in
section 743 of Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-31) for not complying with a recall order are
applicable to all food facilities under this Act as if--
(A) the term ``responsible party'' means ``owner, operator,
or agent in charge of the facility''; and
(B) references to section 423 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 350l) are references to section
402 of this Act.
SEC. 403. 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. 404. 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 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
[[Page S599]]
by substantial evidence on the record as a whole.
(d) Collection Actions for Failure to Pay.--
(1) In general.--If any person fails to pay a civil penalty
assessed under subsection (a) after the order assessing the
penalty has become a final order, or after the court of
appeals described in subsection (b) has entered final
judgment in favor of the Administrator, the Administrator
shall refer the matter to the Attorney General, who shall
institute in a United States district court of competent
jurisdiction a civil action to recover the amount assessed.
(2) Limitation on review.--In a civil action under
paragraph (1), the validity and appropriateness of the order
of the Administrator assessing the civil penalty shall not be
subject to judicial review.
(e) Penalties Paid Into Account.--The Administrator--
(1) shall deposit penalties collected under this section in
an account in the Treasury; and
(2) may use the funds in the account, without further
appropriation or fiscal year limitation--
(A) to carry out enforcement activities under food safety
law; or
(B) to provide assistance to States to inspect retail
commercial food establishments or other food or firms under
the jurisdiction of State food safety programs.
(f) Discretion of the Administrator to Prosecute.--Nothing
in this Act requires the Administrator to report for
prosecution, or for the commencement of an action, the
violation of the food safety law in a case in which the
Administrator finds that the public interest will be
adequately served by the assessment of a civil penalty under
this section.
(g) Remedies Not Exclusive.--The remedies provided in this
section may be in addition to, and not exclusive of, other
remedies that may be available.
SEC. 405. 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. 406. WHISTLEBLOWER PROTECTION.
Section 1012 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 399d) shall apply with respect to any violation
of, or any act or omission an employee reasonably believes to
be a violation of, any provision of this Act to the same
extent and in the same manner as such section 1012 applies
with respect to a violation of, or any act or omission an
employee reasonably believes to be a violation of, any
provision of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.).
SEC. 407. 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 (15 U.S.C. 46)), 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, 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. 408. CITIZEN CIVIL ACTIONS.
(a) Civil Actions.--A person may commence a civil action
against--
(1) a person that violates a regulation (including a
regulation establishing a performance standard), order, or
other action of the Administrator to ensure the safety of
food; or
(2) the Administrator (in his or her capacity as the
Administrator), if the Administrator fails to perform an act
or duty to ensure the safety of food that is not
discretionary under the food safety law.
(b) Court.--
(1) In general.--The action shall be commenced in the
United States district court for the district in which the
defendant resides, is found, or has an agent.
(2) Jurisdiction.--The court shall have jurisdiction,
without regard to the amount in controversy or the
citizenship of the parties, to enforce a regulation
(including a regulation establishing a performance standard),
order, or other action of the Administrator, or to order the
Administrator to perform the act or duty.
(3) Damages.--The court may--
(A) award damages, in the amount of damages actually
sustained; and
(B) if the court determines it to be in the interest of
justice, award the plaintiff the costs of suit, including
reasonable attorney's fees, reasonable expert witness fees,
and penalties.
(c) Remedies Not Exclusive.--The remedies provided for in
this section shall be in addition to, and not exclusive of,
other remedies that may be available.
TITLE V--IMPLEMENTATION
SEC. 501. DEFINITION.
For purposes of this title, the term ``transition period''
means the 12-month period beginning on the effective date of
this Act.
SEC. 502. REORGANIZATION PLAN.
(a) Submission of Plan.--Not later than 180 days after the
effective date of this Act, the President shall transmit to
the appropriate congressional committees a reorganization
plan regarding the following:
(1) The transfer of agencies, personnel, assets, and
obligations to the Administration pursuant to this Act.
(2) Any consolidation, reorganization, or streamlining of
agencies transferred to the Administration pursuant to this
Act.
(b) Plan Elements.--The plan transmitted under subsection
(a) shall contain, consistent with this Act, such elements as
the President determines appropriate, including the
following:
(1) Identification of any functions of agencies designated
to be transferred to the Administration pursuant to this Act
that will not be transferred to the Administration under the
plan.
(2) Specification of the steps to be taken by the
Administrator to organize the Administration, including the
delegation or assignment of functions transferred to the
Administration among the officers of the Administration in
order to permit the Administration to carry out the functions
transferred under the plan.
(3) Specification of the funds available to each agency
that will be transferred to the Administration as a result of
transfers under the plan.
(4) Specification of the proposed allocations within the
Administration of unexpended funds transferred in connection
with transfers under the plan.
(5) Specification of any proposed disposition of property,
facilities, contracts, records, and other assets and
obligations of agencies transferred under the plan.
(6) Specification of the proposed allocations within the
Administration of the functions of the agencies and
subdivisions that are not related directly to ensuring the
safety of food.
(c) Modification of Plan.--The President may, on the basis
of consultations with the appropriate congressional
committees, modify or revise any part of the plan until that
part of the plan becomes effective in accordance with
subsection (d).
(d) Effective Date.--
(1) In general.--The reorganization plan described in this
section, including any modifications or revisions of the plan
under subsection (c), shall become effective for an agency on
the earlier of--
(A) the date specified in the plan (or the plan as modified
pursuant to subsection (c)), except that such date may not be
earlier than 90 days after the date the President has
transmitted the reorganization plan to the appropriate
congressional committees pursuant to subsection (a); or
(B) the end of the transition period.
(2) Statutory construction.--Nothing in this subsection may
be construed to require the transfer of functions, personnel,
records, balances of appropriations, or other assets of an
agency on a single date.
(3) Supercedes existing law.--Paragraph (1) shall apply
notwithstanding section 905(b) of title 5, United States
Code.
SEC. 503. TRANSITIONAL AUTHORITIES.
(a) Provision of Assistance by Officials.--Until the
transfer of an agency to the Administration, any official
having authority over or function relating to the agency
immediately before the effective date of this Act shall
provide the Administrator such assistance, including the use
of personnel and assets, as the Administrator may request in
preparing for the transfer and integration of the agency to
the Administration.
(b) Services and Personnel.--During the transition period,
upon the request of the Administrator, the head of any
Executive 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
[[Page S600]]
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 from
those orders, and payments made pursuant to such orders,
shall be issued 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 the reporting
requirements refer to the agency by name.
SEC. 505. CONFORMING AMENDMENTS.
Section 5313 of title 5, United States Code, is amended by
adding at the end the following new item:
``Administrator of Food Safety.''.
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 any food safety law 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 and the amendments made by this Act take effect on
the date of enactment of this Act.
______
By Mr. ALEXANDER (for himself, Mr. McConnell, Mr. Enzi, Mr.
Isakson, Mr. Rubio, and Mr. Scott):
S. 288. A bill to amend the National Labor Relations Act to reform
the National Labor Relations Board, the Office of the General Counsel,
and the process for appellate review, and for other purposes; to the
Committee on Health, Education, Labor, and Pensions.
Mr. ALEXANDER. Mr. President, today I am reintroducing the NLRB
Reform Act with Senator McConnell.
Our legislation will change the National Labor Relations Board from
an advocate to an umpire.
The board was created 80 years ago to act as an impartial umpire in
labor disputes that threaten the free flow of commerce.
The board's decisions affect about 85 million private-sector workers
and 5.7 million private-sector employers.
But over time, the board has become an advocate for one interest
group over the other--changing positions with each new administration.
There are three significant problems the board faces today:
First, the biggest problem is partisan advocacy. Today, the majority
of the 5-member board is made up of appointees who follow the
president's political leanings. President Obama has appointed 3 labor
union lawyers to the board.
Second, the board has a freewheeling advocate for a general counsel.
The board's most recent general counsels have been exceeding their
statutory authority and bringing questionable cases that threaten
American jobs.
Third, it is too slow to resolve disputes. Right now, 145 cases, that
is 32 percent of the board's caseload, have been pending for more than
a year.
Our bill provides three fixes.
First, it ends partisan advocacy. A 6-member board of 3 Republicans
and 3 Democrats and a majority of 4 will require both sides to find a
middle ground.
Second, it reins in the general counsel. Businesses and unions would
be able to challenge complaints filed by the General Counsel in Federal
district court, and they will have greater transparency about the basis
and legal reasoning of charges brought by the General Counsel.
Third, it encourages timely decisions in two ways. First, either
party in a case before the board may appeal to a Federal Court of
Appeals if the board fails to reach a decision in their case within one
year.
Second, funding for the entire NLRB would be reduced by 20 percent if
the board is not able to decide 90 percent of its cases within one year
over the first 2-year period post-reform.
Our bill would offer these solutions without taking away rights or
remedies for any employee, business, or union.
While the increasing partisanship at the board has occurred in
Republican administrations as well as Democrat administrations, it has
reached a climax in this administration.
Three of President Obama's recent nominees came to the board from a
major labor union's leadership.
One labor law professor at a major university recently said that she
can't even use the most recent textbook, instead she has to resort to
handing out NLRB decisions. The decisions are coming out so rapidly and
this NLRB is venturing into new territory with efforts at rulemaking.
This is no way to maintain a national labor law policy.
______
By Mr. DURBIN (for himself, Mr. Brown, Ms. Klobuchar, Mrs. Boxer,
Mr. Markey, Mr. Cardin, Mr. Franken, Mr. Casey, and Mr.
Schumer):
S. 289. A bill to prioritize funding for an expanded and sustained
national investment in biomedical research; to the Committee on the
Budget.
Mr. DURBIN. 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. 289
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 ``American Cures Act''.
SEC. 2. CAP ADJUSTMENT.
(a) In General.--Section 251(b)(2) of the Balanced Budget
and Emergency Deficit Control Act of 1985 (2 U.S.C.
901(b)(2)) is amended--
[[Page S601]]
(1) by redesignating subparagraph (D) as subparagraph (E);
and
(2) by inserting after subparagraph (C), the following:
``(D) Biomedical research.--
``(i) National institutes of health.--If a bill or joint
resolution making appropriations for a fiscal year is enacted
that specifies amounts for the National Institutes of Health
at the Department of Health and Human Services, then the
adjustments for that fiscal year shall be the amount of
additional new budget authority provided in that Act for such
programs for that fiscal year, but shall not exceed--
``(I) for fiscal year 2016, $1,741,000,000 in additional
new budget authority;
``(II) for fiscal year 2017, $3,422,000,000 in additional
new budget authority;
``(III) for fiscal year 2018, $5,167,000,000 in additional
new budget authority;
``(IV) for fiscal year 2019, $7,085,000,000 in additional
new budget authority;
``(V) for fiscal year 2020, $9,149,000,000 in additional
new budget authority; and
``(VI) for fiscal year 2021, $11,435,000,000 in additional
new budget authority.
``(ii) Centers for disease control and prevention.--If a
bill or joint resolution making appropriations for a fiscal
year is enacted that specifies amounts for the Centers for
Disease Control and Prevention at the Department of Health
and Human Services, then the adjustments for that fiscal year
shall be the amount of additional new budget authority
provided in that Act for such programs for that fiscal year,
but shall not exceed--
``(I) for fiscal year 2016, $716,000,000 in additional new
budget authority;
``(II) for fiscal year 2017, $1,287,000,000 in additional
new budget authority;
``(III) for fiscal year 2018, $1,503,000,000 in additional
new budget authority;
``(IV) for fiscal year 2019, $1,980,000,000 in additional
new budget authority;
``(V) for fiscal year 2020, $2,298,000,000 in additional
new budget authority; and
``(VI) for fiscal year 2021, $2,884,000,000 in additional
new budget authority.
``(iii) Department of defense health program.--If a bill or
joint resolution making appropriations for a fiscal year is
enacted that specifies amounts for the Department of Defense
health program, then the adjustments for that fiscal year
shall be the amount of additional new budget authority
provided in that Act for such programs for that fiscal year,
but shall not exceed--
``(I) for fiscal year 2016, $57,402,000 in additional new
budget authority;
``(II) for fiscal year 2017, $139,213,000 in additional new
budget authority;
``(III) for fiscal year 2018, $226,460,000 in additional
new budget authority;
``(IV) for fiscal year 2019, $322,742,000 in additional new
budget authority;
``(V) for fiscal year 2020, $425,700,000 in additional new
budget authority; and
``(VI) for fiscal year 2021, $540,000,000 in additional new
budget authority.
``(iv) Medical and prosthetics research program of the
department of veterans affairs.--If a bill or joint
resolution making appropriations for a fiscal year is enacted
that specifies amounts for the medical and prosthetics
research program of the Department of Veterans Affairs, then
the adjustments for that fiscal year shall be the amount of
additional new budget authority provided in that Act for such
programs for that fiscal year, but shall not exceed--
``(I) for fiscal year 2016, $25,201,000 in additional new
budget authority;
``(II) for fiscal year 2017, $52,945,000 in additional new
budget authority;
``(III) for fiscal year 2018, $80,866,000 in additional new
budget authority;
``(IV) for fiscal year 2019, $112,189,000 in additional new
budget authority;
``(V) for fiscal year 2020, $146,157,000 in additional new
budget authority; and
``(VI) for fiscal year 2021, $184,027,000 in additional new
budget authority.
``(v) Definitions.--As used in this subparagraph:
``(I) Additional new budget authority.--The term
`additional new budget authority' means--
``(aa) with respect to the National Institutes of Health,
the amount provided for a fiscal year, in excess of the
amount provided in fiscal year 2015, in an appropriation Act
and specified to support the National Institutes of Health;
``(bb) with respect to the Centers for Disease Control and
Prevention, the amount provided for a fiscal year, in excess
of the amount provided in fiscal year 2015, in an
appropriation Act and specified to support the Centers for
Disease Control and Prevention;
``(cc) with respect to the Department of Defense health
program, the amount provided for a fiscal year, in excess of
the amount provided in fiscal year 2015, in an appropriation
Act and specified to support the Department of Defense health
program; and
``(dd) with respect to the medical and prosthetics research
program of the Department of Veterans Affairs, the amount
provided for a fiscal year, in excess of the amount provided
in fiscal year 2015, in an appropriation Act and specified to
support the medical and prosthetics research program of the
Department of Veterans Affairs.
``(II) Centers for disease control and prevention.--The
term `Centers for Disease Control and Prevention' means the
appropriations accounts that support the various institutes,
offices, and centers that make up the Centers for Disease
Control and Prevention.
``(III) Department of defense health program.--The term
`Department of Defense health program' means the
appropriations accounts that support the various institutes,
offices, and centers that make up the Department of Defense
health program.
``(IV) Medical and prosthetics research program of the
department of veterans affairs.--The term `medical and
prosthetics research program of the Department of Veterans
Affairs' means the appropriations accounts that support the
various institutes, offices, and centers that make up the
medical and prosthetics research program of the Department of
Veterans Affairs.
``(V) National institutes of health.--The term `National
Institutes of Health' means the appropriations accounts that
support the various institutes, offices, and centers that
make up the National Institutes of Health.''.
(b) Funding.--There are hereby authorized to be
appropriated--
(1) for the National Institutes of Health, the amounts
provided for under clause (i) of such section 251(b)(2)(D) in
each of fiscal years 2016 through 2021, and such sums as may
be necessary for each subsequent fiscal year;
(2) for the Secretary of Health and Human Services, acting
through the Centers for Disease Control and Prevention, the
amounts provided for under clause (ii) of such section
251(b)(2)(D) in each of fiscal years 2016 through 2021, and
such sums as may be necessary for each subsequent fiscal
year;
(3) for the Department of Defense health program, the
amounts provided for under clause (iii) of such section
251(b)(2)(D) in each of fiscal years 2016 through 2021, and
such sums as may be necessary for each subsequent fiscal
year; and
(4) for the Medical and prosthetics research program of the
Department of Veterans Affairs, the amounts provided for
under clause (iv) of such section 251(b)(2)(D) in each of
fiscal years 2016 through 2021, and such sums as may be
necessary for each subsequent fiscal year.
(c) Minimum Continued Funding Requirement.--Amounts
appropriated for each of the programs and agencies described
in section 251(b)(2)(D) of the Balanced Budget and Emergency
Deficit Control Act of 1985 (as added by subsection (a)) for
each of fiscal years 2016 through 2021, and each subsequent
fiscal year, shall not be less than the amounts appropriated
for such programs and agencies for fiscal year 2015.
(d) Exemption of Certain Appropriations From
Sequestration.--
(1) In general.--Section 255(g)(1)(A) of the Balanced
Budget and Emergency Deficit Control Act (2 U.S.C.
905(g)(1)(A)) is amended by inserting after ``Advances to the
Unemployment Trust Fund and Other Funds (16-0327-0-1-600).''
the following:
``Appropriations under the American Cures Act.''.
(2) Applicability.--The amendment made by this section
shall apply to any sequestration order issued under the
Balanced Budget and Emergency Deficit Control Act of 1985 (2
U.S.C. 900 et seq.) on or after the date of enactment of this
Act.
______
By Mr. CORNYN (for himself, Mr. Flake, Mr. Roberts, Mr. Crapo,
Mr. Daines, Mr. Hatch, Mr. Rounds, Mr. Moran, Mr. Lankford, Mr.
Enzi, Mr. Cruz, and Mrs. Fischer):
S. 292. A bill to amend the Endangered Species Act of 1973 to require
publication on the Internet of the basis for determinations that
species are endangered species or threatened species, and for other
purposes; to the Committee on Environment and Public Works.
Mr. CORNYN. 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. 292
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 ``21st Century Endangered
Species Transparency Act''.
SEC. 2. REQUIREMENT TO PUBLISH ON INTERNET BASIS FOR
LISTINGS.
Section 4(b) of the Endangered Species Act (16 U.S.C.
1533(b)) is amended by adding at the end the following:
``(9) Publication on internet of basis for listings.--The
Secretary shall make publicly available on the Internet the
best scientific and commercial data available that are the
basis for each regulation, including each proposed
regulation, promulgated under subsection (a)(1), except that,
at the request of a Governor or legislature of a State, the
Secretary shall not make available under this paragraph
information regarding which the State has determined public
disclosure is prohibited by a law of that State relating to
the protection of personal information.''.
______
By Mr. CORNYN (for himself, Mr. Flake, Mr. Roberts, Mr. Crapo,
Mr. Boozman, Mr. Hatch, Mr. Rounds, Mr. Moran, Mr. Lankford,
Mr. Vitter, Mr. Risch, Mr. Heller, Mrs. Fischer, and Mr.
Wicker):
[[Page S602]]
S. 293. A bill to amend the Endangered Species Act of 1973 to
establish a procedure for approval of certain settlements; to the
Committee on Environment and Public Works.
Mr. CORNYN. 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. 293
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. DEFINITIONS.
Section 3 of the Endangered Species Act of 1973 (16 U.S.C.
1532) is amended--
(1) by redesignating--
(A) paragraphs (1) through (4) as paragraphs (2) through
(5), respectively;
(B) paragraphs (5) through (10) as paragraphs (7) through
(12), respectively; and
(C) paragraphs (12) through (21) as paragraphs (13) through
(22), respectively;
(2) by adding before paragraph (2) (as so redesignated) the
following:
``(1) Affected parties.--The term `affected party' means
any person, including a business entity, or any State, tribal
government, or local subdivision the rights of which may be
affected by a determination made under section 4(a) in a suit
brought under section 11(g)(1)(C).''; and
(3) by adding after paragraph (5) (as so redesignated) the
following:
``(6) Covered settlement.--The term `covered settlement'
means a consent decree or a settlement agreement in an action
brought under section 11(g)(1)(C).''.
SEC. 2. INTERVENTION; APPROVAL OF COVERED SETTLEMENT.
Section 11(g) of the Endangered Species Act of 1973 (16
U.S.C. 1540) is amended--
(1) in paragraph (3), by adding at the end the following:
``(C) Publishing complaint; intervention.--
``(i) Publishing complaint.--
``(I) In general.--Not later than 30 days after the date on
which the plaintiff serves the defendant with the complaint
in an action brought under paragraph (1)(C) in accordance
with Rule 4 of the Federal Rules of Civil Procedure, the
Secretary of the Interior shall publish the complaint in a
readily accessible manner, including electronically.
``(II) Failure to meet deadline.--The failure of the
Secretary to meet the 30-day deadline described in subclause
(I) shall not be the basis for an action under paragraph
(1)(C).
``(ii) Intervention.--
``(I) In general.--After the end of the 30-day period
described in clause (i), each affected party shall be given a
reasonable opportunity to move to intervene in the action
described in clause (i), until the end of which a party may
not file a motion for a consent decree or to dismiss the case
pursuant to a settlement agreement.
``(II) Rebuttable presumption.--In considering a motion to
intervene by any affected party, the court shall presume,
subject to rebuttal, that the interests of that party would
not be represented adequately by the parties to the action
described in clause (i).
``(III) Referral to alternative dispute resolution.--
``(aa) In general.--If the court grants a motion to
intervene in the action, the court shall refer the action to
facilitate settlement discussions to--
``(AA) the mediation program of the court; or
``(BB) a magistrate judge.
``(bb) Parties included in settlement discussions.--The
settlement discussions described in item (aa) shall include
each--
``(AA) plaintiff;
``(BB) defendant agency; and
``(CC) intervenor.'';
(2) by striking paragraph (4) and inserting the following:
``(4) Litigation costs.--
``(A) In general.--Except as provided in subparagraph (B),
the court, in issuing any final order in any suit brought
under paragraph (1), may award costs of litigation (including
reasonable attorney and expert witness fees) to any party,
whenever the court determines such award is appropriate.
``(B) Covered settlement.--
``(i) Consent decrees.--The court shall not award costs of
litigation in any proposed covered settlement that is a
consent decree.
``(ii) Other covered settlements.--
``(I) In general.--For a proposed covered settlement other
than a consent decree, the court shall ensure that the
covered settlement does not include payment to any plaintiff
for the costs of litigation.
``(II) Motions.--The court shall not grant any motion,
including a motion to dismiss, based on the proposed covered
settlement described in subclause (I) if the covered
settlement includes payment to any plaintiff for the costs of
litigation.''; and
(3) by adding at the end the following:
``(6) Approval of covered settlement.--
``(A) Definition of species.--In this paragraph, the term
`species' means a species that is the subject of an action
brought under paragraph (1)(C).
``(B) In general.--
``(i) Consent decrees.--The court shall not approve a
proposed covered settlement that is a consent decree unless
each State and county in which the Secretary of the Interior
believes a species occurs approves the covered settlement.
``(ii) Other covered settlements.--
``(I) In general.--For a proposed covered settlement other
than a consent decree, the court shall ensure that the
covered settlement is approved by each State and county in
which the Secretary of the Interior believes a species
occurs.
``(II) Motions.--The court shall not grant any motion,
including a motion to dismiss, based on the proposed covered
settlement described in subclause (I) unless the covered
settlement is approved by each State and county in which the
Secretary of the Interior believes a species occurs.
``(C) Notice.--
``(i) In general.--The Secretary of the Interior shall
provide each State and county in which the Secretary of the
Interior believes a species occurs notice of a proposed
covered settlement.
``(ii) Determination of relevant states and counties.--The
defendant in a covered settlement shall consult with each
State described in clause (i) to determine each county in
which the Secretary of the Interior believes a species
occurs.
``(D) Failure to respond.--The court may approve a covered
settlement or grant a motion described in subparagraph
(B)(ii)(II) if, not later than 45 days after the date on
which a State or county is notified under subparagraph (C)--
``(i)(I) a State or county fails to respond; and
``(II) of the States or counties that respond, each State
or county approves the covered settlement; or
``(ii) all of the States and counties fail to respond.
``(E) Proof of approval.--The defendant in a covered
settlement shall prove any State or county approval described
in this paragraph in a form--
``(i) acceptable to the State or county, as applicable; and
``(ii) signed by the State or county official authorized to
approve the covered settlement.''.
______
By Mr. HATCH (for himself, Mr. Schumer, Ms. Ayotte, Mr.
Blumenthal, Mr. Blunt, Ms. Cantwell, Mrs. Capito, Mr. Carper,
Mr. Casey, Mr. Coons, Mr. Cornyn, Mr. Daines, Mrs. Feinstein,
Mr. Franken, Mrs. Gillibrand, Mr. Graham, Mr. Grassley, Mr.
Inhofe, Mr. Isakson, Mr. Kirk, Ms. Klobuchar, Mr. Lee, Mr.
Markey, Mr. McCain, Mrs. Murray, Mr. Perdue, Mr. Portman, Mr.
Roberts, Mr. Rubio, Mr. Thune, Mr. Toomey, Mr. Udall, Mr.
Vitter, Ms. Warren, Mr. Whitehouse, and Mr. Manchin):
S. 295. A bill to amend section 2259 of title 18, United States Code,
and for other purposes; to the Committee on the Judiciary.
Mr. HATCH. Mr. President, today I am introducing legislation to help
victims of child pornography, one of society's most heinous crimes. I
am joined by 34 Senators on both sides of the aisle. I hope this
legislation will soon become law.
Sexually exploiting a child distorts her life and leaves scars long
after the abuse itself ends and the abuser has been prosecuted. For
this reason, the Violence Against Women Act includes a provision
requiring that in such cases a defendant must pay restitution to cover
all of the victim's losses. Those losses can include future lost income
as well as medical care, mental health counseling, and therapy.
Child pornography isn't merely the record of a child's sexual abuse,
it is itself an instance of abuse. The ongoing trafficking and those
images pile harm upon harm. As a result, it becomes even more difficult
for a victim to put together a life that was shattered before it had
barely begun.
As the Supreme Court has recognized, ``every viewing of child
pornography is a repetition of the victim's abuse.'' The current
restitution statute was enacted in 1994, before the Internet became
prime real estate for trafficking of child pornography.
It puts victims in an impossible bind. In a case decided last spring,
the Supreme Court said the current restitution statute requires the
victim to prove how much of her losses were specifically caused by a
single defendant's possession of her images. With a burden like that,
it is no wonder that under this statute victims receive no restitution
at all in more than three-quarters of child pornography cases.
The cruel irony today is that the more individuals who participate in
harming a victim, the less any of them is financially responsible, and
the less timely help the victim will receive. Perpetrators are easily
lost in a crowd.
[[Page S603]]
The bill I introduce today will amend the restitution statute so that
it works for child pornography victims. It is named for Amy and Vicky,
brave women who are the victims of two of the most widely viewed child
pornography series in the world. Amy's case went before the Supreme
Court last year, and my staff worked with the legal team for these
women in developing this bill.
I want to mention in particular James Marsh, whose legal practice in
New York focuses exclusively on helping victims; Professor Paul Cassell
at the University of Utah, who argued Amy's case before the Supreme
Court; and Carol Hepburn, who practices law in Seattle on behalf of
Vicky and many other victims.
This bill changes the current restitution statute in three important
ways so that it works for child pornography victims. First, it gives
judges options for determining a victim's losses and calculating
restitution. Second, it gives judges the ability to impose restitution
on defendants in different kinds of cases to ensure that victims
actually receive meaningful restitution. Third, it shifts the burden of
chasing defendants all over the country from victims to defendants who
can share the restitution costs with other defendants.
Both Amy and Vicky personally support this bill. I am also pleased
that many national victim advocacy groups support this bill, including
the National Center for Missing and Exploited Children, the National
Organization for Victim Assistance, the National Crime Victim Law
Institute, the National Center for Victims of Crime, and the National
Task Force to End Sexual and Domestic Violence Against Women.
Last October I received a letter endorsing this bill signed by the
attorneys general of 43 States, 22 Republicans and 21 Democrats.
I want to share with my colleagues the story of a young man, a Utah
resident, who uses the name Andy.
Between the ages of 7 and 12, he was sexually abused by a trusted
adult and family friend. Dr. David Corwin, the University of Utah child
psychologist who examined him, said that based on 30 years of
experience with child sexual abuse victims, the images and videos of
Andy's abuse were the most disturbing he had ever seen.
According to the FBI, the images and videos created from Andy's abuse
are one of the most widely distributed boy series in the country. The
FBI says that as of last month Andy is a named victim in 726 cases. He
has been granted restitution in 24 of the 101 cases in which he
requested it and has collected anything at all in only 2 cases.
Andy wrote to support the bill I am introducing today. He addresses
letters to the Members of the Congress, which means that he is writing
to each Member of this body. Andy says this legislation will prevent
him from having to spend decades trying to recover minuscule amounts of
restitution from hundreds, if not thousands of defendants all over the
country. I want my colleagues to hear his words:
My images may never be taken off the Internet and may
always be circulating around the country. At least with this
congressional change, I can start to heal, learn how to
handle my circumstances, and re-build my life.
There are many more Amys, Vickys, and Andys than any of us want to
admit, and they need our help. In our system of government, we have the
responsibility to pass or change legislation to address issues and
problems Americans face. All the courts could do was confirm that the
current restitution statute is no longer suited to help child
pornography victims. It is now up to us to do our duty and enact a
statute that will. Amy, Vicky, and Andy are counting on us, and we must
not let them down.
____________________