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108th CONGRESS
2d Session
S. 2910
To establish the Food Safety Administration to protect the public
health by preventing food-borne illness, ensuring the safety of food
intended for human consumption, improving research on contaminants
leading to food-borne illness, and improving security of food from
intentional contamination.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
October 7, 2004
Mr. Durbin introduced the following bill; which was read twice and
referred to the Committee on Agriculture, Nutrition, and Forestry
_______________________________________________________________________
A BILL
To establish the Food Safety Administration to protect the public
health by preventing food-borne illness, ensuring the safety of food
intended for human consumption, improving research on contaminants
leading to food-borne illness, and improving security of food from
intentional contamination.
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
2004''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings; purposes.
Sec. 3. Definitions.
TITLE I--ESTABLISHMENT OF FOOD SAFETY ADMINISTRATION
Sec. 101. Establishment of Food Safety Administration.
Sec. 102. Consolidation of separate food safety and inspection services
and agencies.
Sec. 103. Additional duties of the Administration.
TITLE II--ADMINISTRATION OF FOOD SAFETY PROGRAM
Sec. 201. Administration of national program.
Sec. 202. Registration of food establishments and foreign food
establishments.
Sec. 203. Preventative process controls to reduce adulteration of food.
Sec. 204. Performance standards for contaminants in food.
Sec. 205. Inspections of food establishments.
Sec. 206. Food production facilities.
Sec. 207. Federal and State cooperation.
Sec. 208. Imports.
Sec. 209. Resource plan.
Sec. 210. Traceback.
TITLE III--RESEARCH AND EDUCATION
Sec. 301. Public health assessment system.
Sec. 302. Public education and advisory system.
Sec. 303. Research.
TITLE IV--ENFORCEMENT
Sec. 401. Prohibited Acts.
Sec. 402. Food detention, seizure, and condemnation.
Sec. 403. Notification and recall.
Sec. 404. Injunction proceedings.
Sec. 405. Civil and criminal penalties.
Sec. 406. Presumption.
Sec. 407. Whistleblower protection.
Sec. 408. Administration and enforcement.
Sec. 409. Citizen civil actions.
TITLE V--IMPLEMENTATION
Sec. 501. Definition.
Sec. 502. Reorganization plan.
Sec. 503. Transitional authorities.
Sec. 504. Savings provisions.
Sec. 505. Conforming amendments.
Sec. 506. Additional technical and conforming amendments.
Sec. 507. Regulations.
Sec. 508. Authorization of appropriations.
Sec. 509. Limitation on authorization of appropriations.
Sec. 510. Effective date.
SEC. 2. FINDINGS; PURPOSES.
(a) Findings.--Congress finds that--
(1) the safety of the food supply of the United States is
vital to the public health, to public confidence in the food
supply, and to the success of the food sector of the Nation's
economy;
(2) lapses in the protection of the food supply and loss of
public confidence in food safety are damaging to consumers and
the food industry, and place a burden on interstate commerce;
(3) the safety and security of the food supply requires an
integrated, system-wide approach to preventing food-borne
illness, a thorough and broad-based approach to basic and
applied research, and intensive, effective, and efficient
management of the Nation's food safety program;
(4) the task of preserving the safety of the food supply of
the United States faces tremendous pressures with regard to--
(A) emerging pathogens and other contaminants and
the ability to detect all forms of contamination;
(B) an aging and immune compromised population,
with a growing number of people at high-risk for food-
borne illnesses;
(C) an increasing volume of imported food, without
adequate monitoring and inspection; and
(D) maintenance of rigorous inspection of the
domestic food processing and food service industries;
(5) Federal food safety standard setting, inspection,
enforcement, and research efforts should be based on the best
available science and public health considerations and food
safety resources should be systematically deployed in ways that
most effectively prevent food-borne illness;
(6) the Federal food safety system is fragmented, with at
least 12 Federal agencies sharing responsibility for food
safety, and operates under laws that do not reflect current
conditions in the food system or current scientific knowledge
about the cause and prevention of food-borne illness;
(7) the fragmented Federal food safety system and outdated
laws preclude an integrated, system-wide approach to preventing
food-borne illness, to the effective and efficient operation of
the Nation's food safety program, and to the most beneficial
deployment of food safety resources;
(8) the National Academy of Sciences recommended in the
report ``Ensuring Safe Food from Production to Consumption''
that Congress establish by statute a unified and central
framework for managing Federal food safety programs, and
recommended modifying Federal statutes so that inspection,
enforcement, and research efforts are based on scientifically
supportable assessments of risks to public health; and
(9) the lack of a single focal point for food safety
leadership in the United States undercuts the ability of the
United States to exert food safety leadership internationally,
which is detrimental to the public health and the international
trade interests of the United States.
(b) Purposes.--The purposes of this Act are--
(1) to establish a single agency to be known as the ``Food
Safety Administration''--
(A) to regulate food safety and labeling to protect
the public health;
(B) to ensure that food establishments fulfill
their responsibility to produce food in a manner that
protects the public health of all people in the United
States;
(C) to lead an integrated, system-wide approach to
food safety and to make more effective and efficient
use of resources to prevent food-borne illness; and
(D) to provide a single focal point for food safety
leadership, both nationally and internationally;
(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 the Federal food safety laws to achieve
more effective application and efficient management of the laws
for the protection and improvement of public health.
SEC. 3. DEFINITIONS.
In this Act:
(1) Administration.--The term ``Administration'' means the
Food Safety Administration established under section 101(a)(1).
(2) Administrator.--The term ``Administrator'' means the
Administrator of Food Safety appointed under section 101(a)(3).
(3) Adulterated.--
(A) In general.--The term ``adulterated'' has the
meaning described in subsections (a) through (c) of
section 402 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 342(a)-(c)).
(B) Inclusion.--The term ``adulterated'' includes
bearing or containing a contaminant that causes illness
or death among sensitive populations.
(4) Agency.--The term ``agency'' has the meaning given that
term in section 551 of title 5, United States Code.
(5) Category 1 food establishment.--The term ``category 1
food establishment'' means a food establishment that routinely
slaughters animals for human consumption.
(6) Category 2 food establishment.--The term ``category 2
food establishment'' means a food establishment that processes
raw meat, poultry, seafood products, and other products that
the Administrator determines by regulation to be at high risk
of contamination and the processes of which do not include a
step validated to destroy contaminants.
(7) Category 3 food establishment.--The term ``category 3
food establishment'' means a food establishment that processes
meat, poultry, seafood products, and other products that the
Administrator determines by regulation to be at high risk of
contamination and whose processes include a step validated to
destroy contaminants.
(8) Category 4 food establishment.--The term ``category 4
food establishment'' means a food establishment that processes
all other categories of food products not described in
paragraphs (5) through (7).
(9) Category 5 food establishment.--The term ``category 5
food establishment'' means a food establishment that stores,
holds, or transports food products prior to delivery for retail
sale.
(10) Contaminant.--The term ``contaminant'' includes a
bacterium, chemical, natural or manufactured toxin, virus,
parasite, prion, physical hazard, or other human pathogen that
when found on or in food can cause human illness, injury, or
death.
(11) Contamination.--The term ``contamination'' refers to a
presence of a contaminant in food.
(12) Food.--
(A) In general.--The term ``food'' means a product
intended to be used for food or drink for a human.
(B) Inclusions.--The term ``food'' includes any
product (including a meat food product, as defined in
section 1(j) of the Federal Meat Inspection Act (21
U.S.C. 601(j))), capable for use as human food that is
made in whole or in part from any animal, including
cattle, sheep, swine, or goat, or poultry (as defined
in section 4 of the Poultry Products Inspection Act (21
U.S.C. 453)).
(C) Exclusion.--The term ``food'' does not include
dietary supplements, as defined in section 201(ff) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(ff)).
(13) Food establishment.--
(A) In general.--The term ``food establishment''
means a slaughterhouse, factory, warehouse, or facility
owned or operated by a person located in any State that
processes food.
(B) Exclusions.--For the purposes of registration,
the term ``food establishment'' does not include a
farm, restaurant, other retail food establishment,
nonprofit food establishment in which food is prepared
for or served directly to the consumer, or fishing
vessel (other than a fishing vessel engaged in
processing, as that term is defined in section 123.3 of
title 21, Code of Federal Regulations).
(14) Food production facility.--The term ``food production
facility'' means any farm, ranch, orchard, vineyard,
aquaculture facility, confined animal-feeding operation, or
animal feed production facility.
(15) Food safety law.--The term ``food safety law'' means--
(A) the provisions of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) related to and
requiring the safety, labeling, and inspection of food,
infant formulas, food additives, pesticide residues,
and other substances present in food under that Act;
(B) the provisions of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) and of any other
Act that are administered by the Center for Veterinary
Medicine of the Food and Drug Administration;
(C) the Poultry Products Inspection Act (21 U.S.C.
451 et seq.);
(D) the Federal Meat Inspection Act (21 U.S.C. 601
et seq.);
(E) the Egg Products Inspection Act (21 U.S.C. 1031
et seq.);
(F) the Sanitary Food Transportation Act of 1990
(49 U.S.C. App. 2801 et seq.);
(G) the provisions of the Humane Methods of
Slaughter Act of 1978 (Public Law 95-448) administered
by the Food Safety and Inspection Service;
(H) the provisions of this Act; and
(I) such other provisions of law related to and
requiring food safety, labeling, inspection, and
enforcement as the President designates by Executive
order as appropriate to include within the jurisdiction
of the Administration.
(16) Foreign food establishment.--
(A) In general.--The term ``foreign food
establishment'' means a slaughterhouse, factory,
warehouse, or facility located outside the United
States that processes food that is imported into the
United States without further processing or packaging
inside the United States.
(B) Further processing or packaging.--A food shall
not be considered to have undergone further processing
or packaging solely because labeling was added or a
similar activity of a de minimis nature was carried out
with respect to the food.
(17) Interstate commerce.--The term ``interstate commerce''
has the meaning given that term in section 201(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(b)).
(18) Misbranded.--The term ``misbranded'' has the meaning
given that term in section 403 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 343).
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