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II
113th CONGRESS
1st Session
S. 1502
IN THE SENATE OF THE UNITED STATES
September 12, 2013
Mrs. Gillibrand
introduced the following bill; which was read twice and referred to the
Committee on Agriculture, Nutrition, and
Forestry
A BILL
To require the Secretary of Agriculture to protect
against foodborne illnesses, provide enhanced notification of recalled meat,
poultry, eggs, and related food products, and for other
purposes.
1.
Short title; table of
contents
(a)
Short
title
This Act may be cited
as the Safe Meat and Poultry Act of
2013.
(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.
TITLE I—Safe meat and poultry
Sec. 101. Definition of adulterated.
TITLE II—Food safety
Sec. 201. Food safety.
Sec. 202. Good commercial practices in receiving and processing
live poultry.
TITLE III—Research and education
Sec. 301. Definition of Secretary.
Sec. 302. Public health assessment system.
Sec. 303. Public education and advisory system.
Sec. 304. Research.
TITLE IV—Criminal penalties and other provisions
Sec. 401. Criminal penalties.
Sec. 402. Ongoing assessment of occupational
health.
Sec. 403. Reports and evaluation of implementation.
Sec. 404. Authorization of appropriations.
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, public
confidence in the food supply, and the success of the food sector of the
economy of the United States;
(2) lapses in the
protection of the food supply and the loss of public confidence that results
from foodborne illness outbreaks and food recalls are damaging to consumers and
the food industry, and place a burden on interstate commerce and international
trade;
(3) the Food Safety
and Inspection Service of the Department of Agriculture has jurisdiction over
meat, poultry, and egg products;
(4)
(A) events recent to the
date of enactment of this Act demonstrate that the food safety system
administered by the Food Safety and Inspection Service is not effective in
controlling risk in regulated food; and
(B) these events have adversely affected
consumer confidence;
(5) new and emerging
pathogens such as antibiotic-resistant Salmonella, and enterohemorrhagic (EHEC)
Shiga toxin-producing serotypes of Escherichia coli (E. coli) place an
increasing number of people at high risk for foodborne illness;
(6) several court
decisions, relying on outdated understandings of the risks and nature of
microbiological contaminants, have issued rulings that impose barriers to
reasonable efforts by the Food Safety and Inspection Service to prevent
foodborne illness;
(7) 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 deployed in ways that most effectively prevent
foodborne illness;
(8) the Federal Meat
Inspection Act (21 U.S.C. 601 et seq.) was first enacted in 1907, the Poultry
Products Inspection Act (21 U.S.C. 451 et seq.) was first enacted in 1957, and
the last substantial amendment to those laws occurred 44 years before the date
of enactment of this Act;
(9) Congress passed
the Department of Agriculture Reorganization Act of 1994 (7 U.S.C. 6901 et
seq.), establishing the office of the Under Secretary of Agriculture for Food
Safety in order to centralize and modernize the food safety system at the
Department of Agriculture; and
(10) improving
Federal oversight of food safety requires a modern food safety mandate and
clear authorities to effectively protect the public from foodborne diseases
associated with the products that the Food Safety and Inspection Service
regulates.
(b)
Purposes
The
purposes of this Act are—
(1) to establish an
effective, preventive food safety system administered by the Food Safety and
Inspection Service—
(A) to regulate food
safety and labeling to strengthen the protection of the public health;
(B) to focus new
attention on pathogens of public health significance, such as EHEC, including
Shiga toxin-producing E. coli (STEC), and Salmonella strains, including strains
that are antibiotic resistant; and
(C) to participate
with the Food and Drug Administration in an integrated, systemwide approach to
food safety and to make more effective and efficient use of resources to
prevent foodborne illness;
(2) to modernize and
strengthen the Federal food safety system to ensure more effective application
and efficient management of the laws for the protection and improvement of
public health; and
(3) to establish that
food establishments have responsibility to ensure that all stages of
production, processing, and distribution of the products of the food
establishments, or under the control of the food establishments, satisfy the
requirements of this Act.
I
Safe
meat and poultry
101.
Definition of
adulterated
(a)
Meat and meat
food products
Section 1(m) of
the Federal Meat Inspection Act (21 U.S.C. 601(m)) is amended—
(1) in paragraph (8),
by striking or at the end;
(2) in paragraph (9),
by striking the period at the end and inserting ; or; and
(3) by adding at the
end the following:
(10) if it bears or
contains a pathogen or contaminant associated with serious illness or
death.
.
(b)
Poultry and
poultry products
Section 4(g)
of the Poultry Products Inspection Act (21 U.S.C. 453(g)) is amended—
(1) in paragraph (7),
by striking or at the end;
(2) in paragraph (8),
by striking the period at the end and inserting ; or; and
(3) by adding at the
end the following:
(9) if it bears or
contains a pathogen or contaminant associated with serious illness or
death.
.
(c)
Eggs and egg
products
Section 4(a) of the Egg Products Inspection Act (21
U.S.C. 1033(a)) is amended—
(1) in paragraph (7),
by striking or at the end;
(2) in paragraph (8),
by striking the period at the end and inserting ; or; and
(3) by adding at the
end the following:
(9) if it bears or
contains a pathogen or contaminant associated with serious illness or
death.
.
II
Food
safety
201.
Food
safety
(a)
In
general
Subtitle G of the
Department of Agriculture Reorganization Act of 1994 (7 U.S.C. 6981 et seq.) is
amended—
(1) by inserting after the subtitle heading the
following:
I
Administration
;
and
(2) by adding at the end the following:
II
Food
safety
263.
Definitions
In this part:
(1)
Adulterated
(A)
In
general
The term adulterated has the meaning given
the term in—
(i) in the case of
poultry or a poultry product, section 4 of the Poultry Products Inspection Act
(21 U.S.C. 453);
(ii) in the case of
meat or a meat food product, section 1 of the Federal Meat Inspection Act (21
U.S.C. 601); and
(iii) in the case of
an egg or egg product, section 4 of the Egg Products Inspection Act (21 U.S.C.
1033).
(B)
Inclusion
The
term adulterated includes bearing or containing a contaminant that
has the potential to cause illness or death among sensitive populations.
(2)
Agency
The
term agency has the meaning given the term in section 551 of title
5, United States Code.
(3)
Contaminant
The
term contaminant includes a biological, chemical, physical, or
radiological food safety hazard that when found on or in food can cause human
illness, injury, or death.
(4)
Contamination
The
term contamination refers to the presence of a contaminant in
food.
(5)
Food
The
term food means—
(A) a meat or a meat
food product (within the meaning of the Federal Meat Inspection Act (21 U.S.C.
601 et seq.));
(B) an egg or egg
product (as defined in section 4 of the Egg Products Inspection Act (21 U.S.C.
1033)); or
(C) a poultry or
poultry product (as defined in section 4 of the Poultry Products Inspection Act
(21 U.S.C. 453)).
(6)
Food
establishment
(A)
In
general
The term food establishment means a
slaughterhouse, factory, warehouse, or facility owned or operated by a person
located in any State that processes food or a facility that holds, stores, or
transports food or food ingredients.
(B)
Exclusions
The
term food establishment does not include a farm, restaurant, other
retail food establishment, or nonprofit food establishment in which food is
prepared for or served directly to the consumer.
(7)
Food safety
law
The term food safety law means—
(A) the Poultry
Products Inspection Act (21 U.S.C. 451 et seq.);
(B) the Federal Meat
Inspection Act (21
U.S.C. 601 et seq.);
(C) the Egg Products
Inspection Act (21
U.S.C. 1031 et seq.);
(D) the provisions of
Public Law 85–765 (commonly known as the Humane Methods of Slaughter Act
of 1958) (7 U.S.C. 1901 et seq.) administered by the Food Safety and
Inspection Service;
(E) this part;
and
(F) such other
provisions of law relating 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 Secretary.
(8)
Foreign food
establishment
The term foreign food establishment
means a slaughterhouse, factory, warehouse, or facility located outside the
United States that processes food for consumption that is imported into the
United States or food ingredients.
(9)
Interstate
commerce
The term interstate commerce has the
meaning given the term in section 201 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C.
321).
(10)
Misbranded
The
term misbranded has the meaning given the term in—
(A) in the case of
poultry or a poultry product, section 4 of the Poultry Products Inspection Act
(21 U.S.C. 453);
(B) in the case of
meat or a meat food product, section 1 of the Federal Meat Inspection Act (21
U.S.C. 601); and
(C) in the case of an
egg or egg product, section 4 of the Egg Products Inspection Act (21 U.S.C.
1033).
(11)
Process
The
term process or processing means the commercial
harvesting, slaughter, packing, preparation, or manufacture of food.
(12)
Safe
The
term safe refers to human and animal health.
(13)
Secretary
The
term Secretary means the Secretary of Agriculture, acting through
the Under Secretary of Food Safety.
(14)
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.
(15)
Statistically
valid
The term statistically valid means, with
respect to a study, evaluated and conducted under standards established by the
National Institute of Standards and Technology.
264.
Performance
standards for food safety
(a)
Definitions
In
this section:
(1)
Appropriate
level of protection
The term appropriate level of
protection means a level of food safety and public health protection
that—
(A) if achievable by
commercially available techniques, reduces a known pathogen or contaminant to a
level that does not present a demonstrated risk of illness or death to
consumers, including sensitive groups; or
(B) in all other
cases, is the lowest reasonably achievable level of a microbiologic or
contaminant food safety hazard that can best protect public health.
(2)
Food safety
objective
The term food safety objective means an
objective that establishes the maximum frequency or concentration of a
microbial or contaminant hazard in a regulated food product at the time of
handling and consumption by a consumer that still provides the appropriate
level of protection.
(3)
Pathogen
reduction performance standard
The term pathogen reduction
performance standard means a standard that establishes the degree to
which a step or combination of steps in the production, processing,
distribution, or preparation of a food must operate to achieve the required
level of control over microbiological contamination.
(4)
Performance
criteria
The term performance criteria means a
criteria that establishes the effect of one or more control measures needed to
meet or contribute to meet a performance objective.
(5)
Performance
objective
The term performance objective means an
objective that establishes the maximum frequency or concentration of a
microbial or contaminant hazard in a regulated food product during a processing
step that contributes to the achievement of a food safety objective or other
end measure or a performance standard.
(6)
Public health
goals and objectives
The term public health goals and
objectives means goals and objectives establishing the desired outcome
associated with reducing the burden of foodborne disease in society.
(b)
Standards, goals,
and objectives
In order to protect the public health and promote
food safety, the Secretary shall prescribe—
(1) pathogen surveys
to determine current levels of food contamination and to enable the Secretary
to assess compliance;
(2) public health
goals and objectives; and
(3) pathogen
reduction performance standards—
(A) to reduce
pathogens in food; and
(B) to achieve public
health goals and objectives.
(c)
List of
pathogens
(1)
In
general
In consultation with the Secretary of Health and Human
Services, and taking into account data available from the Centers for Disease
Control and Prevention, the Secretary shall identify the pathogens that make a
significant contribution to the total burden of foodborne disease associated
with food.
(2)
Publication;
updates
The Secretary shall—
(A) publish a list of
the pathogens described in paragraph (1) not later than 180 days after the date
of enactment of this section; and
(B) update and
publish the list annually thereafter.
(d)
Pathogen
surveys
(1)
In
general
Not later than 180 days after the date of enactment of
this section, the Secretary shall initiate the planning and subsequent
implementation of comprehensive surveys to determine the current levels and
incidence of contamination of food products with the pathogens listed under
subsection (c), including the variation in levels and incidence of
contamination among establishments.
(2)
Publication
Not
later than 2 years after the date of enactment of this section, the Secretary
shall compile, and publish in the Federal Register, the results of the
surveys.
(3)
Updates
At
least once every 3 years after the preceding surveys are conducted, the
Secretary shall—
(A) conduct surveys
described in paragraph (1); and
(B) compile and
publish the results of the surveys in accordance with paragraph (2).
(e)
Public health
goals and objectives
(1)
In
general
Not later than 1 year after the completion of pathogen
surveys under subsection (d), and in coordination with the Secretary of Health
and Human Services and the Director of the Centers for Disease Control and
Prevention, the Secretary shall establish public health goals and food safety
objectives to achieve measurable population-based targets and food safety
targets for the reduction of foodborne illness and the exposure of the public
to pathogens.
(2)
Requirements
The
goals described in subsection (b)(2) shall be updated every 2 years according
to current epidemiological studies in foodborne illness and the most recently
updated information from the Centers for Disease Control and Prevention about
the prevalence of foodborne illness.
(f)
Pathogen
reduction performance standards
(1)
In
general
The pathogen reduction performance standards required
under subsection (b) shall ensure the lowest level or incidence of
contamination that is reasonably achievable using the best available processing
technology and practices.
(2)
Current
contamination
In determining what is reasonably achievable, the
Secretary shall consider data on current levels or incidence of contamination,
including what is being achieved by establishments in the upper quartile of
performance in controlling the level or incidence of contamination.
(3)
Initial
pathogens
Not later than 3 years after the date of enactment of
this section, the Secretary shall propose pathogen reduction performance
standards for at least 2 pathogens from the list published under subsection
(c).
(4)
Subsequent
pathogens
Not later than 1 year after proposing pathogen
reduction standards for the initial pathogens under paragraph (3), and annually
thereafter, the Secretary shall propose a pathogen reduction performance
standard for at least 1 pathogen each year from the list published under
subsection (c) until standards have been proposed for all pathogens on the
list.
(5)
Final
standards
Not later than 1 year after proposing a pathogen
reduction standard for a pathogen under this subsection, the Secretary shall
promulgate a final pathogen reduction standard and propose sampling standards
and procedures for the pathogen in regulated products.
(g)
Performance
standards
The performance standards established under this
section shall include—
(1) food safety
objectives that set the level of a contaminant that provides the appropriate
level of protection;
(2) zero tolerances,
including zero tolerances for fecal matter, in addition to any zero-tolerance
standards in effect on the day before the date of enactment of this section,
when necessary to protect against significant adverse health outcomes;
(3) performance
objectives, such as log reduction criteria for cooked products, when sufficient
to ensure the safety of processed food;
(4) in the absence of
data to support a performance standard described in paragraph (1), (2), or (3),
as determined by the Secretary, standards that define required performance in
terms of best reasonably achievable performance, using best available
technologies, interventions, and practices; or
(5) any other food
safety objectives or performance criteria, as determined by the
Secretary.
(h)
Review of
standards
(1)
In
general
Not later than 3 years after promulgation of a final
pathogen reduction performance standard for a pathogen under subsection (f)(5),
the Secretary shall review each standard to determine whether the standard
continues to ensure the lowest level or incidence of contamination that is
reasonably achievable using the best available processing technology and
practices, taking into account the most recent survey conducted under
subsection (d).
(2)
Public health
goals
The goals described in subsection (e) shall be—
(A) used in addition
to the most recent survey conducted under subsection (d) to evaluate the
pathogen performance standards set by the Secretary; and
(B) considered when
the Secretary reviews and revises the final pathogen reduction performance
standards in accordance with subsection (f).
(3)
Revisions
The
Secretary shall revise the standards, as necessary, to comply with subsection
(f).
(i)
Enforcement
(1)
Sampling
program
(A)
In
general
Not later than 1 year after the promulgation of a
performance standard under this section, the Secretary shall implement a
sampling program to determine whether food establishments are complying with
the performance standards promulgated under this section.
(B)
Requirement
The
program established under this paragraph shall be at least as stringent as the
Hazard Analysis and Critical Control Point System requirements established
under part 417 of title 9, Code of Federal Regulations (or successor
regulation).
(2)
Inspections
If
the Secretary determines that a food establishment fails to meet a standard
promulgated under this section, and the food establishment fails to take
appropriate corrective action as determined by the Secretary, the Secretary
shall, as appropriate—
(A) order a recall of
food from the food establishment under section 269;
(B) require enhanced
inspection of the food establishment;
(C) withdraw the mark
of inspection from the food establishment; or
(D) take other
appropriate enforcement action concerning the food establishment, including
revocation of the grant of inspection.
(j)
Newly identified
contaminants
Notwithstanding any other provision of this section,
the Secretary shall promulgate interim performance standards for newly
identified contaminants as necessary to prevent disease outbreaks or other
hazards to the public health.
(k)
Enforcement of
certain regulations
The
Secretary shall ensure that, as compared to regulations under chapter III of
title 9, Code of Federal Regulations, that are in effect as of September 1,
2013, regulations promulgated under this part relating to—
(1) carcass
inspection and safety are at least as stringent;
(2) the frequency of
inspection services are at least as frequent; and
(3) staffing levels
are at least as high so as to ensure public health.
265.
Pathogen reduction and testing
(a)
In
general
Not later than 180 days after the date of enactment of
this section or the subsequent adoption of performance standards under section
264, the Secretary shall require that food establishments described in
subsection (b) sample for the presence of identified pathogens at any points in
production or processing that are identified by the Secretary.
(b)
Application
This
section applies to—
(1)
(A) all slaughterhouses or
processing establishments that produce more than 25,000 pounds of trim per day;
or
(B) grinding facilities that grind more
than 25,000 pounds of trim or bench trim per day; and
(2) effective
beginning on the date that is 3 years after the date of enactment of this
section—
(A) to all food
establishments that produce or grind trim or bench trim; and
(B) such other food
establishments as are designated by the Secretary.
(c)
Administration
To
carry out this section, the Secretary shall—
(1) establish
sampling standards and procedures;
(2) define
appropriate sampling plans for food establishments through guidance
documents;
(3) promulgate
regulations that require that the food establishment takes corrective action
when violative products are found through testing and establishes measures to
prevent reoccurrence; and
(4) upon inspection,
review the definition of lot sizes established by food establishments to ensure
that—
(A) there is a
rational justification for the lot size; and
(B) no lot is more
than 2,000 pounds.
(d)
Testing
Food
establishments undertaking testing under this section shall use—
(1) sampling
standards and procedures determined by the Secretary under section 264(f)(5);
and
(2) a laboratory
accredited under section 266.
266.
Laboratory
accreditation
(a)
Recognition of
laboratory accreditation
(1)
In
general
Not later than 2 years after the date of enactment of
this section, the Secretary shall—
(A) establish a
program for the testing of meat and meat food products by accredited
laboratories;
(B) establish and
maintain on the Internet Web site of the Department an up-to-date and publicly
available registry of accreditation bodies recognized by the Secretary and
laboratories accredited by a recognized accreditation body, including the name
of, contact information for, and other information considered appropriate by
the Secretary about the accreditation bodies and laboratories; and
(C) require, as a
condition of recognition or accreditation, as appropriate, that recognized
accreditation bodies and accredited laboratories report to the Secretary any
changes that would affect the recognition of the accreditation body or the
accreditation of the laboratory.
(2)
Program
requirements
The program established under paragraph (1)(A) shall
provide for the recognition of laboratory accreditation bodies that meet
criteria established by the Secretary for accreditation of laboratories,
including independent private laboratories and laboratories run and operated by
a Federal agency (including the Department of Commerce), State, or locality
with a demonstrated capability to conduct one or more sampling and analytical
testing methodologies for meat and meat food products.
(3)
Increasing the
number of qualified laboratories
The Secretary shall work with
the laboratory accreditation bodies recognized under paragraph (1), as
appropriate, to increase the number of qualified laboratories that are eligible
to perform testing under this subsection beyond the number so qualified on the
date of enactment of this section.
(4)
Limited
distribution
In the interest of national security, the Secretary,
in coordination with the Secretary of Homeland Security, may determine the
time, manner, and form in which the registry established under paragraph (1)(B)
is made publicly available.
(5)
Foreign
laboratories
Accreditation bodies recognized by the Secretary
under paragraph (1) may accredit laboratories that operate outside the United
States, so long as the laboratories meet the accreditation standards applicable
to domestic laboratories accredited under this subsection.
(6)
Model
laboratory standards
(A)
In
general
The Secretary shall develop model standards that a
laboratory shall meet to be accredited by a recognized accreditation body for a
specified sampling or analytical testing methodology and included in the
registry provided for under paragraph (1).
(B)
Requirements
In
developing the model standards, the Secretary shall—
(i) consult existing
standards for guidance; and
(ii) include—
(I) methods to ensure
that—
(aa) appropriate
sampling, analytical procedures (including rapid analytical procedures), and
commercially available techniques are followed and reports of analyses are
certified as true and accurate;
(bb) internal quality
systems are established and maintained;
(cc) procedures exist
to evaluate and respond promptly to complaints regarding analyses and other
activities for which the laboratory is accredited; and
(dd) individuals who
conduct the sampling and analyses are qualified by training and experience to
do so; and
(II) any other
criteria determined appropriate by the Secretary.
(7)
Review of
recognition
To ensure compliance with the requirements of this
subsection, the Secretary—
(A) shall
periodically, and in no case less frequently than once every 5 years,
reevaluate accreditation bodies recognized under paragraph (1) and may
accompany auditors from an accreditation body to assess whether the
accreditation body meets the criteria for recognition; and
(B) shall promptly
revoke the recognition of any accreditation body found not to be in compliance
with the requirements of this subsection, specifying, as appropriate, any terms
and conditions necessary for laboratories accredited by the accreditation body
to continue to perform testing as described in this subsection.
(b)
Testing
Procedures
(1)
In
general
Not later than 30 months after the date of enactment of
this section, food testing shall be conducted by Federal laboratories or
non-Federal laboratories that have been accredited for the appropriate sampling
or analytical testing methodology or methodologies by a recognized
accreditation body on the registry established by the Secretary under
subsection (a)(1)(B)—
(A) in response to a
specific testing requirement under this Act (including implementing
regulations), when applied to address an identified or suspected meat or meat
food product safety problem; and
(B) as required by
the Secretary, as the Secretary considers appropriate, to address an identified
or suspected food safety problem.
(2)
Results of
testing
(A)
In
general
The results of any testing under this section shall be
sent directly to the applicable food establishment and the Secretary, unless
the Secretary by regulation exempts test results from the submission
requirement if the Secretary determines that the results do not contribute to
the protection of public health.
(B)
Electronic
submission
Test results required to be submitted may be submitted
to the Secretary through electronic means.
(3)
Exception
The
Secretary may waive requirements under this subsection if—
(A) a new methodology
has been developed and validated but a laboratory has not yet been accredited
to perform the methodology; and
(B) the use of the
methodology is necessary to prevent, control, or mitigate a food emergency or
foodborne illness outbreak.
(c)
Review by
Secretary
If food sampling and testing performed by a laboratory
run and operated by a State or locality that is accredited by a recognized
accreditation body on the registry established by the Secretary under
subsection (a) result in a State recalling a food, the Secretary shall review
the sampling and testing results for the purpose of determining the need for a
national recall or other compliance and enforcement activities.
(d)
No Limit on
Secretarial Authority
Nothing in this section limits the ability
of the Secretary to review and act on information from food testing, including
determining the sufficiency of the information and testing.
267.
Traceback
(a)
In
general
The Secretary, in order to protect the public health,
shall establish requirements for a national system for tracing food and
food-producing animals from point of slaughter to retail sale, subject to
subsection (b).
(b)
Applicability
Traceability
requirements shall—
(1) be established in
accordance with regulations and guidelines issued by the Secretary; and
(2) apply to food
establishments.
(c)
Traceability
(1)
In
general
The Secretary shall implement tracing protocols using
methods and technologies to enable the Food Safety and Inspection Service to
rapidly trace adulterated food to—
(A) the source of the
contamination to determine the original site source of the adulteration or
contamination; and
(B) destinations to
which the food has been shipped.
(2)
Requirements
(A)
In
general
Tracing protocols under this subsection shall include the
collection of documentary and other relevant material to enable rapid tracing,
including—
(i) food
establishment identification data;
(ii) a description of
the food;
(iii) shipping
marks;
(iv) bar coding;
and
(v) disclosure of
sole-source or multiple-source origin.
(B)
Timing
The
collection of documentary and other relevant material to enable rapid tracing
under subparagraph (A) shall occur at the time that transfer of the relevant
food is completed.
(C)
Certification
The
onsite inspector and a responsible food establishment representative shall
certify that the documentary and other tracing material collected under
subparagraph (A) are complete and accurate.
(3)
Tracing of
adulterated and contaminated food
If a food sample tests positive
or is indicated to test positive for a contaminant, the Secretary shall
immediately conduct a trace—
(A) to identify all
sites of contamination, including preparation, packaging, and slaughtering
establishments;
(B) to identify the
original source of contamination; and
(C) to identify any
recipient of the food, other than the consumer, or food that may have been
similarly affected.
(d)
Relationship to
country of origin labeling
Nothing in this section prevents or
interferes with implementation of the country of origin labeling requirements
of subtitle D of the Agricultural Marketing Act of 1946 (7 U.S.C. 1638 et
seq.).
268.
International
food safety assurance
(a)
International
audits
The Secretary shall ensure that international audits of
eligible foreign country food safety systems shall—
(1) occur no less
than annually; and
(2) be of sufficient
scope to protect public health.
(b)
Imports
As soon as practicable after the date of
enactment of this section, the Secretary shall promulgate regulations under
which the Secretary may remove a country from the appropriate list maintained
by the Secretary of countries allowed to import one or more foods into the
United States if—
(1) the country refuses to allow the Secretary
to conduct such onsite audits as the Secretary determines to be necessary to
verify the safety of the food to be imported; or
(2) imports of food from the country have been
suspended more than once during a 5-year period for major food safety
infractions.
269.
Notification
and recall
(a)
Definitions
In
this section:
(1)
Class I
recall
The term Class I recall means a food recall
classification defined by the Secretary that covers a health-hazard situation
in which there is a reasonable probability that the use of the food or food
product being recalled will cause a serious, adverse health consequence, or
death.
(2)
Retail
establishment
The term retail establishment means a
grocery store or other retail establishment that sells food and food products
directly to consumers.
(3)
Summary
notice
The term summary notice means the 1-page
summary notice described in subsection (d).
(b)
Notice to
Secretary of violation
(1)
In
general
A person that has reason to believe that any food
introduced into or in interstate commerce, or held for sale (whether or not the
first sale) after shipment in interstate commerce, may be in violation of the
food safety law shall immediately notify the Secretary of the identity and
location of the food.
(2)
Manner of
notification
Notification under paragraph (1) shall be made in
such manner and by such means as the Secretary may require by
regulation.
(c)
Recall and
consumer notification
(1)
Voluntary
actions
If the Secretary determines that food is in violation of
the food safety law when introduced into or while in interstate commerce or
while held for sale (whether or not the first sale) after shipment in
interstate commerce or that there is a reasonable probability that the food, if
consumed, would present a threat to public health, as determined by the
Secretary, the Secretary shall give the appropriate persons (including the
manufacturers, importers, distributors, or retailers of the food) an
opportunity—
(A) to cease
distribution of the food;
(B) to notify all
persons—
(i) processing,
distributing, or otherwise handling the food to immediately cease such
activities with respect to the food; or
(ii) to
which the food has been distributed, transported, or sold, to immediately cease
distribution of the food;
(C) to recall the
food;
(D) in conjunction with
the Secretary, to provide notice of the finding of the Secretary—
(i) to
consumers to whom the food was, or may have been, distributed; and
(ii) to State and
local public health officials; or
(E) to take any
combination of the measures described in this paragraph, as determined by the
Secretary to be appropriate in the circumstances.
(2)
Mandatory
actions
If a person referred to in paragraph (1) refuses to or
does not adequately carry out the actions described in that paragraph within
the time period and in the manner prescribed by the Secretary, the Secretary
shall—
(A) have authority to
control and possess the food or recall the food, including ordering the
shipment of the food from the food establishment to the Secretary—
(i) at
the expense of the food establishment; or
(ii) in an emergency
(as determined by the Secretary), at the expense of the Secretary; and
(B) by order, require,
as the Secretary determines to be necessary, the person to immediately—
(i) cease distribution
of the food;
(ii) notify all
persons—
(I) processing,
distributing, or otherwise handling the food to immediately cease such
activities with respect to the food; or
(II) if the food has
been distributed, transported, or sold, to immediately cease distribution of
the food; and
(iii) recall
contaminated food.
(3)
Notification to
consumers by Secretary
In accordance with subsection (d), the
Secretary shall, as the Secretary determines to be necessary, provide notice of
the finding of the Secretary under paragraph (1)—
(A) to consumers to
whom the food was, or may have been, distributed;
(B) to State and local
public health officials; and
(C) to such other
persons as the Secretary determines appropriate.
(4)
Nondistribution
by notified persons
A person that processes, distributes, or
otherwise handles the food, or to which the food has been distributed,
transported, or sold, and that is notified under paragraph (1)(B) or (2)(B)
shall immediately cease distribution of the food.
(5)
Availability of
records to Secretary
Each person referred to in paragraph (1)
that processed, distributed, or otherwise handled food shall make available to
the Secretary information necessary to carry out this subsection, as determined
by the Secretary, regarding—
(A) persons that
processed, distributed, or otherwise handled the food; and
(B) persons to which
the food has been transported, sold, distributed, or otherwise handled.
(d)
Consumer recall
notification
(1)
Distribution of
information
In the case of any Class I recall, the Secretary
shall, to the maximum extent practicable, distribute to each retail
establishment that has received or is likely to have received recalled product
in the United States a 1-page summary notice containing product information of
each food or food product subject to the Class I recall.
(2)
Distribution of
information
The Secretary shall require each retail establishment
that receives a summary notice—
(A) to post a copy of
the summary notice at each cash register of the retail establishment;
(B) to post a copy of
the summary notice on the shelving unit on which the food or food product was
sold; or
(C) in the case of a
retail establishment that uses a customer card system to track customer
purchases or demographics—
(i) to place a call
to each customer that purchased a recalled food or food product to inform the
customer of the Class I recall; or
(ii) to make
available to each customer that purchased a recalled food or food product with
a targeted coupon with information about the recalled food or food
product.
(3)
Assistance
In
cooperation with and, when necessary, with direct assistance from the Director
of the Centers for Disease Control and Prevention and the Centers of Excellence
of the Food and Drug Administration, the Secretary shall provide assistance to
regional, State, and local agencies to assist in carrying out this section
through activities such as providing resources, including timely information
concerning symptoms and tests, for frontline health professionals interviewing
individuals as part of routine surveillance and outbreak investigations.
(4)
Availability of
lists of retail consignees during food recalls
The Secretary
shall make publicly available the names and locations of retail establishment
consignees of recalled food or food products that the Secretary compiles in
connection with a recall for which there is a reasonable probability that the
use of the food or food product could cause serious adverse health consequences
or death.
(e)
Informal
hearings on orders
(1)
In
general
The Secretary shall provide any person subject to an
order under subsection (c) with an opportunity for an informal hearing, to be
held as soon as practicable but not later than 2 business days after the
issuance of the order.
(2)
Scope of the
hearing
In a hearing under paragraph (1), the Secretary shall
consider the actions required by the order and any reasons why the food that is
the subject of the order should not be recalled.
(f)
Post-Hearing
recall orders
(1)
Amendment of
order
If, after providing an opportunity for an informal hearing
under subsection (e), the Secretary determines that there is a reasonable
probability that the food that is the subject of an order under subsection (c),
if consumed, would present a threat to the public health, the Secretary, as the
Secretary determines to be necessary, may—
(A) amend the order to
require recall of the food or other appropriate action;
(B) specify a
timetable in which the recall shall occur;
(C) require periodic
reports to the Secretary describing the progress of the recall; and
(D) provide notice of
the recall to consumers to whom the food was, or may have been,
distributed.
(2)
Vacation of
orders
If, after providing an opportunity for an informal hearing
under subsection (e), the Secretary determines that adequate grounds do not
exist to continue the actions required by the order, the Secretary shall vacate
the order.
(g)
Remedies not
exclusive
The remedies provided in this section shall be in
addition to, and not exclusive of, other remedies that may be available.
270.
Enforcement
and administration
(a)
Civil
penalties
(1)
Civil
sanctions
(A)
Civil
penalty
(i)
In
general
Any person that commits an act that violates the food
safety law (including a regulation promulgated or order issued under a Federal
food safety law) may be assessed a civil penalty by the Secretary of not more
than $10,000 for each such act.
(ii)
Separate
offense
Each act described in clause (i) and each day during
which that act continues shall be considered a separate offense.
(B)
Other
requirements
(i)
Written
order
The civil penalty described in subparagraph (A) shall be
assessed by the Secretary by a written order, which shall specify the amount of
the penalty and the basis for the penalty under clause (ii) considered by the
Secretary.
(ii)
Amount of
penalty
Subject to subparagraph (A)(i), the amount of the civil
penalty shall be determined by the Secretary, 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.
(iii)
Review of
order
The order may be reviewed only in accordance with paragraph
(2).
(2)
Judicial
review
(A)
In
general
An order assessing a civil penalty under paragraph (1)
shall be a final order unless the person—
(i) 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
(ii) simultaneously
serves a copy of the petition by certified mail to the Secretary.
(B)
Filing of
record
Not later than 45 days after the service of a copy of the
petition under subparagraph (A)(ii), the Secretary shall file in the court a
certified copy of the administrative record upon which the order was
issued.
(C)
Standard of
review
The findings of the Secretary relating to the order shall
be set aside only if found to be unsupported by substantial evidence on the
record as a whole.
(3)
Collection
actions for failure to pay
(A)
In
general
If any person fails to pay a civil penalty assessed under
paragraph (1) after the order assessing the penalty has become a final order,
or after the court of appeals described in paragraph (2) has entered final
judgment in favor of the Secretary, the Secretary 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.
(B)
Limitation on
review
In a civil action under subparagraph (A), the validity and
appropriateness of the order of the Secretary assessing the civil penalty shall
not be subject to judicial review.
(4)
Penalties paid
into account
The Secretary—
(A) shall deposit
penalties collected under this section in an account in the Treasury;
and
(B) may use the funds
in the account, without further appropriation or fiscal year limitation—
(i) to
carry out enforcement activities under food safety law; or
(ii) to provide
assistance to States to inspect retail commercial food establishments or other
food or firms under the jurisdiction of State food safety programs.
(5)
Discretion of
the Secretary to prosecute
Nothing in this part requires the
Secretary to report for prosecution, or for the commencement of an action, the
violation of the food safety law in a case in which the Secretary finds that
the public interest will be adequately served by the assessment of a civil
penalty under this section.
(6)
Remedies not
exclusive
The remedies provided in this subsection are in
addition to, and not exclusive of, other remedies that may be available under
this or any other Act.
(b)
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.
(c)
Whistleblower
protection
(1)
In
general
No Federal employee, employee of a Federal contractor or
subcontractor, or any individual employed by a company or other entity that is
a regulated establishment or any other entity involved in the food supply
system (referred to in this subsection as a covered individual),
may be discharged, demoted, suspended, threatened, harassed, or in any other
manner discriminated against, because of any lawful act done by the covered
individual—
(A) to provide
information, cause information to be provided, or otherwise assist in an
investigation regarding any conduct that the covered individual reasonably
believes constitutes a violation of this Act or a food safety law, including
any related rules or regulations, or that the covered individual reasonably
believes constitutes a threat to the public health, if the information or
assistance is provided to, or the investigation is conducted by—
(i) a
Federal regulatory or law enforcement agency;
(ii) a
Member or committee of Congress; or
(iii) a person with
supervisory authority over the covered individual (or such other individual who
has the authority to investigate, discover, or terminate misconduct);
(B) to file, cause to
be filed, testify, participate in, or otherwise assist in a proceeding or
action filed or about to be filed relating to a violation of any law, rule, or
regulation; or
(C) to refuse to
violate or assist in the violation of any law, rule, or regulation.
(2)
Enforcement
action
(A)
Complaint
(i)
In
general
A covered individual who alleges discharge or other
discrimination by any person in violation of paragraph (1) may seek relief
under paragraph (3) by filing a complaint with the Secretary of Labor.
(ii)
Legal
action
If the Secretary of Labor has not issued a final decision
by the date that is 210 days after the date on which the complaint is filed and
there is no showing that the delay is due to the bad faith of the claimant, the
claimant may bring an action at law or equity for de novo review in the
appropriate district court of the United States, which shall have jurisdiction
over such an action without regard to the amount in controversy.
(B)
Procedure
An
action under subparagraph (A) shall be governed under the rules and procedures
established in section 1012 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 399d).
(C)
Remedies
A
covered individual who prevails in any action under subparagraph (A) shall be
entitled to remedies equivalent to relief provided under section 1012(b)(4)(B)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 399d(b)(4)(B)).
(3)
Applicability
This
subsection shall apply and be carried out in accordance with section 1012 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 399d), including the
relation of the whistleblower protection provided under this subsection to the
rights of employees, other laws, and international agreements, and the
inability of an employee to waive the whistleblower protection.
(4)
Rights retained
by the covered individual
(A)
In
general
Nothing in this subsection diminishes the rights,
privileges, or remedies of any covered individual under any Federal or State
law, or under any collective bargaining agreement.
(B)
Prohibition on
waiver
The rights and remedies in this subsection may not be
waived by any agreement, policy, form, or condition of employment.
(d)
Administration
and enforcement
(1)
In
general
For the efficient administration and enforcement of the
food safety law, the provisions (including provisions relating to penalties) of
sections 6, 8, 9, and 10 of the Federal Trade
Commission Act (15 U.S.C. 46, 48, 49, and 50) (except
subsections (c) through (h) of section 6 of that Act), relating to the
jurisdiction, powers, and duties of the Federal Trade Commission and the
Attorney General to administer and enforce that Act, and to the rights and
duties of persons with respect to whom the powers are exercised, shall apply to
the jurisdiction, powers, and duties of the Secretary 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.
(2)
Inquiries and
actions
(A)
In
general
The Secretary, in person or by such agents as the
Secretary may designate, may prosecute any inquiry necessary to carry out the
duties of the Secretary under the food safety law in any part of the United
States.
(B)
Powers
The
powers conferred by sections 9 and 10 of the Federal Trade Commission Act (15 U.S.C. 49 and
50) on the United States district courts may be exercised for the purposes of
this part by any United States district court of competent jurisdiction.
(e)
Citizen civil
actions
(1)
Civil
actions
A person may commence a civil action against the
Secretary (in his or her capacity as the Secretary)—
(A) if the Secretary
fails to perform an act or duty that is not discretionary under a food safety
law and the failure to perform that act or duty presents a clear, demonstrated,
and serious present threat to public health; but
(B) only after the
person has—
(i) filed a petition
with the Secretary; and
(ii) given the
Secretary 180 days to comply with nondiscretionary acts or duties.
(2)
Court
(A)
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.
(B)
Jurisdiction
The
court shall have jurisdiction, without regard to the amount in controversy, or
the citizenship of the parties, to require the Secretary to perform a
nondiscretionary act or duty under a food safety law, if—
(i) it is proven
that—
(I)
(aa) the act or duty is not
discretionary and is critical to public health protection; and
(bb) the Secretary has the appropriate
financial resources to perform the act or duty;
(II)
(aa) the Secretary was
given 180 days to perform the act or duty prior to the filing of an action;
and
(bb) the Secretary did not perform the act
or duty; and
(ii) the plaintiff
presents credible evidence, including, if applicable, evidence representing the
current scientific knowledge, that indicates that an act or duty necessary to
regulate or control a food safety hazard has not been performed by the
Secretary.
(C)
Damages
The
court may—
(i) require the
Secretary to perform the act or duty in question towards a standard of
protecting public health; and
(ii) award the
plaintiff part or all of the costs of suit, including reasonable attorney’s
fees and reasonable expert witness fees, if—
(I) awarding the fees
is in the interest of justice;
(II) the failure of
the Secretary to perform a required act or duty is found to be capricious or
negligent; and
(III) awarding the
fees would not reduce resources applied to public health inspections.
271.
Administrative
enforcement methodology for serious violations
(a)
In
general
Not later than 1 year after the date of enactment of this
section, the Secretary shall develop a system of escalating penalties for
situations in which there are serious or egregious violations of any food
safety laws.
(b)
Methodology
The
Secretary shall design the system under subsection (a) based on sound
methodology so as to provide incentives to reduce repeated serious or egregious
violations.
(c)
Definition
For
purposes of this section, the Secretary shall define the term serious or
egregious violation of any food safety law, which—
(1) shall include any
current violations that are grounds for a suspension, withholding, or
revocation of grant of inspection under a food safety law; and
(2) may include any
other violations that constitute a severe violation of major food safety law
requirements, which may include intransigent repeated noncompliance for less
than serious violations that indicate a food establishment is unwilling or
negligent to bring the food establishment into compliance over a period of
repeat circumstances lasting at least 1 year since the last documented severe
violation.
272.
Nonroutine
inspection fees for repeated or serious noncompliance
(a)
In
general
Not later than 180 days after the date of enactment of
this section, the Secretary shall establish performance-based fees for food
establishments requiring nonroutine inspection services due to severe or
repeated violations of food safety laws.
(b)
Inclusions
Fees
established under this section shall include, at minimum, fees for—
(1) food safety
assessments in response to serious or repeated food safety violations;
(2) humane handling
assessments in response to serious or repeated violations of Public Law 85–765
(commonly known as the Humane Methods of Slaughter Act of 1958)
(7 U.S.C. 1901 et seq.);
(3) any actions or
enhanced inspections associated with a mandatory recall; and
(4) follow-up
microbiological testing associated with any nonroutine requirements.
(c)
Amount
The
Secretary shall establish the amount of the fees at a level that recuperates
the full costs or a reasonable portion of the nonroutine inspection
services.
(d)
Small and very
small food establishments
The Secretary may adjust the terms,
conditions, and rates of fees established under this section so as to minimize
economic impacts on small and very small establishments.
(e)
Use of
fees
The Secretary shall use any fees collected under this
section to bolster inspection or other programs in the Office of Field
Operations, without the need for further appropriation.
(f)
Guidance
Not
later than 1 year after the date of enactment of this section, the Secretary
shall publish and make publically available guidance in the form of a list of
eligible types of violations for nonroutine inspection fees, including
estimated rates for
services.
.
(b)
Conforming
amendment
Section 296(b) of the Department of Agriculture
Reorganization Act of 1994 (7 U.S.C. 7014(b)) is amended—
(1) in paragraph
(6)(C), by striking or at the end;
(2) in paragraph (7),
by striking the period at the end and inserting ; or; and
(3) by adding at the
end the following:
(8) the authority of
the Secretary to carry out food safety activities under part II of subtitle
G.
.
202.
Good
commercial practices in receiving and processing live poultry
The Poultry Products Inspection Act is
amended by inserting after section 9 (21 U.S.C. 458) the following:
9A.
Good commercial
practices in receiving and processing live poultry
(a)
In
general
An establishment
shall use reasonable care, handling, lairage, slaughtering, and other good
commercial practices, as defined by the Secretary through regulation, during
the handling and processing of live poultry, including—
(1) to prevent injury, death by means other
than slaughter, or other avoidable losses; and
(2) to allow for prompt disposition or, if
appropriate, prompt euthanasia and sanitary disposal of severely injured,
severely ill, incapacitated, distressed, or moribund live poultry.
(b)
Prohibition
An establishment shall not present poultry
for slaughter if the poultry is—
(1) moribund, distressed, or incapacitated;
or
(2) severely ill or injured.
(c)
Live poultry
processing plan
(1)
In
general
The Secretary shall
require establishments to implement, through the hazard analysis and critical
control points plans of the establishments or by other appropriate means, a
live poultry processing plan that includes—
(A) a euthanasia action plan;
(B) ante-mortem segregation and disposition
procedures when appropriate for potentially severely injured, distressed, ill,
incapacitated, or moribund poultry;
(C) facility outcome standards;
(D) employee training and competency
requirements; and
(E) such other requirements as are appropriate
to ensure that only live poultry are presented for slaughter in accordance with
this section and other applicable food safety laws.
(2)
Requirement
The implementation, design, and
effectiveness of the practices contained in live poultry processing plans by
establishments shall include routine agency veterinary oversight.
(3)
Review
The Secretary shall review the requirements
under paragraph (1) at least every 5 years—
(A) to ensure the requirements reflect the
principles of this section; and
(B) to consider new improvements in available
practices and
technology.
.
III
Research and
education
301.
Definition of
Secretary
Except as otherwise
provided, in this title, the term Secretary means the Secretary of
Agriculture, acting through the Under Secretary of Food Safety.
302.
Public health
assessment system
(a)
In
general
The Secretary, 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) resolve
data-sharing barriers, including those relating to the application of the
Health Insurance Portability and Accountability Act of 1996 (Public Law
104–191; 110 Stat. 1936), to ensure access to the applicable data systems of
the Centers for Disease Control and Prevention and to the databases made
available by a State;
(2) maintain an active
surveillance system of food, food products, and epidemiological evidence
submitted by States to the Centers for Disease Control and Prevention based on
a representative proportion of the population of the United States;
(3) assess the
frequency and sources of human illness in the United States associated with the
consumption of food;
(4) maintain a
state-of-the-art DNA matching system and epidemiological system dedicated to
foodborne illness identification, outbreaks, and containment; and
(5) have access to the
surveillance data created via monitoring and statistical studies conducted as
part of inspections carried out by or for the Secretary.
(b)
Public health
sampling
(1)
In
general
Not later than 1 year after the date of enactment of this
Act, the Secretary shall establish guidelines for a sampling system under which
the Secretary shall take and analyze samples of food—
(A) to assist the
Secretary in carrying out this title;
(B) to assess the
nature, frequency of occurrence, and quantities of contaminants in food;
and
(C) to enforce this
title and other food safety laws.
(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 Secretary, such other information, including analysis of monitoring and
verification samples, as the Secretary determines may be useful and appropriate
in assessing the occurrence of contaminants in food.
(c)
Assessment of
health hazards
(1)
In
general
Through the surveillance system referred to in subsection
(a) and the sampling system described in subsection (b), the Secretary shall
work in collaboration with the Director of the Centers for Disease Control and
Prevention, the Commissioner of Food and Drugs, and other appropriate Federal,
State, local, and tribal agencies—
(A) to rank food
categories under the jurisdiction of the Secretary based on the hazard to human
health presented by the food category;
(B) to identify
appropriate industry and regulatory approaches to minimize hazards in the food
supply; and
(C) to assess the
public health environment for emerging diseases, including zoonosis, for their
risk of appearance in the United States food supply.
(2)
Components of
analysis
The analysis under subsection (b)(1) may include—
(A) a comparison of the
safety of commercial processing with the health hazards associated with food
that is harvested for recreational or subsistence purposes and prepared
noncommercially;
(B) a comparison of the
safety of food that is domestically processed with the health hazards
associated with food that is processed outside the United States;
(C) a description of
contamination originating from handling practices that occur prior to or after
the sale of food to consumers; and
(D) use of comparative risk assessments.
303.
Public
education and advisory system
(a)
Public
education
(1)
In
general
The Secretary, in collaboration with the Director of the
Centers for Disease Control and Prevention and the Commissioner of Food and
Drugs and in cooperation with private and public organizations, including the
cooperative extension services and building on the efforts of appropriate State
and local entities, shall establish a national public education program on food
safety.
(2)
Requirements
The
program shall provide—
(A) information to the
public regarding Federal standards and best practices and promotion of public
awareness, understanding, and acceptance of those standards and
practices;
(B) information for
health professionals—
(i) to
improve diagnosis and treatment of food-related illness; and
(ii) to
advise individuals at special risk for food-related illnesses;
(C) information to
increase consumer and health professional awareness of relative risks of
different regulated products and consumer practices in preparing, handling, and
consuming the products; and
(D) such other
information or advice to consumers and other persons as the Secretary
determines will promote the purposes of this subtitle.
(b)
Health
advisories
The Secretary, in consultation with other Federal
departments and agencies as the Secretary 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.
304.
Research
(a)
In
general
The Secretary, acting through the Under Secretary for
Research, Education, and Economics, shall conduct research to carry out this
title and improve food safety, including studies—
(1) to improve
sanitation and food safety practices in the processing of food;
(2) to develop
improved techniques to monitor and inspect food;
(3) to develop
efficient, rapid, and sensitive methods to detect contaminants in food;
(4) to determine the
sources of contamination of contaminated food;
(5) to develop food
consumption data;
(6) to identify ways
that animal production techniques could improve the safety of the food
supply;
(7) to draw upon
research and educational programs that exist at the State and local
level;
(8) to use the DNA
matching system and other processes to identify and control pathogens;
(9) to address common
and emerging zoonotic diseases;
(10) to develop
methods to reduce or destroy harmful pathogens before, during, and after
processing;
(11) to analyze the
incidence of antibiotic resistance as the resistance pertains to the food
supply and develop new methods to reduce the transfer of antibiotic resistance
to humans;
(12) to conduct
research to inform risk communications, including—
(A) conducting
studies regarding the knowledge and behavior of industry, health professionals,
consumers, and other appropriate stakeholders towards food safety; and
(B) developing a
protocol that will balance public welfare needs associated with the food safety
research of the Department of Agriculture and the requirements of chapter 35 of
title 44, United States Code (commonly known as the Paperwork
Reduction Act) to account for the time-sensitive nature of
communicating with the public about food safety programs;
(13) to improve live
animal health, handling, transport, and slaughter methods; and
(14) to conduct other
research that supports the purposes of this title.
(b)
Contract
authority
The Secretary may enter into contracts and agreements
with any State, institution of higher education, Federal Government agency, or
person to carry out this section.
IV
Criminal
penalties and other provisions
401.
Criminal
penalties
(a)
Poultry
Products Inspection Act
Section 12 of the Poultry Products
Inspection Act (21 U.S.C. 461) is amended by adding at the end the
following:
(d)
Knowing
introduction into commerce of unsafe food
(1)
Criminal
sanctions
(A)
In
general
Except as provided in subparagraph (B), a person that
knowingly produces or introduces into commerce poultry or a poultry product
that is unsafe or otherwise adulterated or misbranded shall be imprisoned for
not more than 10 years or fined not more than $25,000, or both.
(B)
Severe
violations
A person that commits a violation described in
subparagraph (A) after a conviction of that person under this subsection has
become final, or commits such a violation with the intent to defraud or
mislead, shall be imprisoned for not more than 20 years or fined not more than
$100,000, or both.
(2)
Penalties paid
into account
The Secretary shall deposit penalties collected
under this subsection in the account described in section 270(a)(4) of the
Department of Agriculture Reorganization Act of 1994.
(3)
Discretion of
the Secretary to prosecute
Nothing in this subsection requires
the Secretary to report for prosecution, or for the commencement of an action,
a violation described in paragraph (1) in a case in which the Secretary finds
that the public interest will be adequately served by the assessment of a civil
penalty.
(4)
Remedies not
exclusive
The remedies provided in this subsection are in
addition to, and not exclusive of, other remedies that may be available under
this or any other
Act.
.
(b)
Federal Meat
Inspection Act
Section 406 of the Federal Meat Inspection Act (21
U.S.C. 676) is amended by adding at the end the following:
(d)
Knowing
introduction into commerce of unsafe food
(1)
Criminal
sanctions
(A)
In
general
Except as provided in subparagraph (B), a person that
knowingly produces or introduces into commerce meat or a meat food product that
is unsafe or otherwise adulterated or misbranded shall be imprisoned for not
more than 10 years or fined not more than $25,000, or both.
(B)
Severe
violations
A person that commits a violation described in
subparagraph (A) after a conviction of that person under this subsection has
become final, or commits such a violation with the intent to defraud or
mislead, shall be imprisoned for not more than 20 years or fined not more than
$100,000, or both.
(2)
Penalties paid
into account
The Secretary shall deposit penalties collected
under this subsection in the account described in section 270(a)(4) of the
Department of Agriculture Reorganization Act of 1994.
(3)
Discretion of
the Secretary to prosecute
Nothing in this subsection requires
the Secretary to report for prosecution, or for the commencement of an action,
a violation described in paragraph (1) in a case in which the Secretary finds
that the public interest will be adequately served by the assessment of a civil
penalty.
(4)
Remedies not
exclusive
The remedies provided in this subsection are in
addition to, and not exclusive of, other remedies that may be available under
this or any other
Act.
.
(c)
Egg Products
Inspection Act
Section 12 of the Egg Products Inspection Act (21
U.S.C. 1041) is amended by adding at the end the following:
(f)
Knowing
introduction into commerce of unsafe food
(1)
Criminal
sanctions
(A)
In
general
Except as provided in subparagraph (B), a person that
knowingly produces or introduces into commerce eggs or egg products that are
unsafe or otherwise adulterated or misbranded shall be imprisoned for not more
than 10 years or fined not more than $25,000, or both.
(B)
Severe
violations
A person that commits a violation described in
subparagraph (A) after a conviction of that person under this subsection has
become final, or commits such a violation with the intent to defraud or
mislead, shall be imprisoned for not more than 20 years or fined not more than
$100,000, or both.
(2)
Penalties paid
into account
The Secretary shall deposit penalties collected
under this subsection in the account described in section 270(a)(4) of the
Department of Agriculture Reorganization Act of 1994.
(3)
Discretion of
the Secretary to prosecute
Nothing in this subsection requires
the Secretary to report for prosecution, or for the commencement of an action,
a violation described in paragraph (1) in a case in which the Secretary finds
that the public interest will be adequately served by the assessment of a civil
penalty.
(4)
Remedies not
exclusive
The remedies provided in this subsection are in
addition to, and not exclusive of, other remedies that may be available under
this or any other
Act.
.
402.
Ongoing
assessment of occupational health
Not later than 2 years after the date of
enactment of this Act, and not less than every 2 years thereafter, the
Secretary of Agriculture, acting through the Under Secretary of Food Safety, in
cooperation with the Director of the National Institute for Occupational Safety
and Health and the Assistant Secretary of Labor for Occupational Safety and
Health, shall publish a report that—
(1) describes
occupational health and safety trends throughout federally inspected
establishments; and
(2) includes
recommendations for improving environmental health for private and Federal
employees, including findings of appropriate maximum line speed allowances in
processing and slaughter establishments, as determined by the Secretary of
Labor in consultation with the Secretary of Agriculture to ensure an
appropriate level of occupational safety.
403.
Reports and
evaluation of implementation
(a)
Secretary
(1)
In
general
Not later than 1 year after the date of enactment of this
Act and each of the following 2 years, the Secretary of Agriculture shall
submit to Congress a report that—
(A) describes the
progress of the Secretary in implementing this Act and the amendments made by
this Act;
(B) includes any
requests for additional resources or clarification or modification of policy;
and
(C) suggests any
necessary technical or conforming amendments.
(2)
Public health
information system
Not later than 1 year after the date of
enactment of this Act and each of the following 3 years, the Secretary of
Agriculture shall submit to Congress a report that describes—
(A) the effectiveness
of the public health information system of the Food Safety and Inspection
Service;
(B) whether the
system is effective, accurate, and reflects actual program implementation;
and
(C) whether data
contained in the system is usable to evaluate public health programs.
(b)
Comptroller
General
Not later than 5 years after the date of enactment of
this Act, the Comptroller General of the United States shall—
(1) carry out a
comprehensive evaluation of the implementation and effectiveness of the
implementation of this Act and the amendments made by this Act,
including—
(A) management of
agency resources;
(B) the ability of
industry to comply; and
(C) the public health
and food safety outcomes achieved; and
(2) submit to
Congress a report describing the results of the evaluation.
404.
Authorization
of appropriations
(a)
In
general
Subject to subsection (b), there are authorized to be
appropriated to carry out this Act and the amendments made by this Act such
sums as are necessary for each fiscal year.
(b)
Limitation on
appropriations
(1)
In
general
For the fiscal year that includes the date of enactment
of this Act, the amount authorized to be appropriated to carry out this Act
(other than section 304) and the amendments made by this Act shall not
exceed—
(A) the amount
appropriated for that fiscal year for the Food Safety and Inspection Service,
including any additional separate appropriations for the activities of the
Under Secretary for Food Safety; or
(B) the amount
appropriated for the Food Safety and Inspection Service and the Under Secretary
for Food Safety for the preceding fiscal year, if as of the date of enactment
of this Act, the relevant appropriations for the fiscal year that includes the
date of enactment of this Act have not yet been made.
(2)
Research
For
the fiscal year that includes the date of enactment of this Act, the amount
authorized to be appropriated to carry out section 304 shall not exceed—
(A) the amount
appropriated for that fiscal year for the research, education, and economics
mission area of the Department of Agriculture, including any additional
separate appropriations for the activities of the Under Secretary for Research,
Education, and Economics; or
(B) the amount
appropriated for the research, education, and economics mission area of the
Department of Agriculture and the Under Secretary for Research, Education, and
Economics for the preceding fiscal year, if as of the date of enactment of this
Act, the relevant appropriations for the fiscal year that includes the date of
enactment of this Act have not yet been made.