[Congressional Record Volume 156, Number 172 (Tuesday, December 21, 2010)]
[House]
[Pages H8861-H8890]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
FDA FOOD SAFETY MODERNIZATION ACT
Mr. DINGELL. Mr. Speaker, pursuant to House Resolution 1781, I call
up the bill (H.R. 2751) to accelerate motor fuel savings nationwide and
provide incentives to registered owners of high polluting automobiles
to replace such automobiles with new fuel efficient and less polluting
automobiles, with the Senate amendments thereto, and I have a motion at
the desk.
The Clerk read the title of the bill.
The SPEAKER pro tempore. The Clerk will designate the Senate (Mr.
Cuellar) amendments.
The text of the Senate amendments is as follows:
Senate amendments:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``FDA Food
Safety Modernization Act''.
(b) References.--Except as otherwise specified, whenever in
this Act an amendment is expressed in terms of an amendment
to a section or other provision, the reference shall be
considered to be made to a section or other provision of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(c) Table of Contents.--The table of contents for this Act
is as follows:
Sec. 1. Short title; references; table of contents.
TITLE I--IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS
Sec. 101. Inspections of records.
Sec. 102. Registration of food facilities.
Sec. 103. Hazard analysis and risk-based preventive controls.
Sec. 104. Performance standards.
Sec. 105. Standards for produce safety.
Sec. 106. Protection against intentional adulteration.
Sec. 107. Authority to collect fees.
Sec. 108. National agriculture and food defense strategy.
Sec. 109. Food and Agriculture Coordinating Councils.
Sec. 110. Building domestic capacity.
Sec. 111. Sanitary transportation of food.
Sec. 112. Food allergy and anaphylaxis management.
Sec. 113. New dietary ingredients.
Sec. 114. Requirement for guidance relating to post harvest processing
of raw oysters.
[[Page H8862]]
Sec. 115. Port shopping.
Sec. 116. Alcohol-related facilities.
TITLE II--IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY
PROBLEMS
Sec. 201. Targeting of inspection resources for domestic facilities,
foreign facilities, and ports of entry; annual report.
Sec. 202. Laboratory accreditation for analyses of foods.
Sec. 203. Integrated consortium of laboratory networks.
Sec. 204. Enhancing tracking and tracing of food and recordkeeping.
Sec. 205. Surveillance.
Sec. 206. Mandatory recall authority.
Sec. 207. Administrative detention of food.
Sec. 208. Decontamination and disposal standards and plans.
Sec. 209. Improving the training of State, local, territorial, and
tribal food safety officials.
Sec. 210. Enhancing food safety.
Sec. 211. Improving the reportable food registry.
TITLE III--IMPROVING THE SAFETY OF IMPORTED FOOD
Sec. 301. Foreign supplier verification program.
Sec. 302. Voluntary qualified importer program.
Sec. 303. Authority to require import certifications for food.
Sec. 304. Prior notice of imported food shipments.
Sec. 305. Building capacity of foreign governments with respect to food
safety.
Sec. 306. Inspection of foreign food facilities.
Sec. 307. Accreditation of third-party auditors.
Sec. 308. Foreign offices of the Food and Drug Administration.
Sec. 309. Smuggled food.
TITLE IV--MISCELLANEOUS PROVISIONS
Sec. 401. Funding for food safety.
Sec. 402. Employee protections.
Sec. 403. Jurisdiction; authorities.
Sec. 404. Compliance with international agreements.
Sec. 405. Determination of budgetary effects.
TITLE I--IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS
SEC. 101. INSPECTIONS OF RECORDS.
(a) In General.--Section 414(a) (21 U.S.C. 350c(a)) is
amended--
(1) by striking the heading and all that follows through
``of food is'' and inserting the following: ``Records
Inspection.--
``(1) Adulterated food.--If the Secretary has a reasonable
belief that an article of food, and any other article of food
that the Secretary reasonably believes is likely to be
affected in a similar manner, is'';
(2) by inserting ``, and to any other article of food that
the Secretary reasonably believes is likely to be affected in
a similar manner,'' after ``relating to such article'';
(3) by striking the last sentence; and
(4) by inserting at the end the following:
``(2) Use of or exposure to food of concern.--If the
Secretary believes that there is a reasonable probability
that the use of or exposure to an article of food, and any
other article of food that the Secretary reasonably believes
is likely to be affected in a similar manner, will cause
serious adverse health consequences or death to humans or
animals, each person (excluding farms and restaurants) who
manufactures, processes, packs, distributes, receives, holds,
or imports such article shall, at the request of an officer
or employee duly designated by the Secretary, permit such
officer or employee, upon presentation of appropriate
credentials and a written notice to such person, at
reasonable times and within reasonable limits and in a
reasonable manner, to have access to and copy all records
relating to such article and to any other article of food
that the Secretary reasonably believes is likely to be
affected in a similar manner, that are needed to assist the
Secretary in determining whether there is a reasonable
probability that the use of or exposure to the food will
cause serious adverse health consequences or death to humans
or animals.
``(3) Application.--The requirement under paragraphs (1)
and (2) applies to all records relating to the manufacture,
processing, packing, distribution, receipt, holding, or
importation of such article maintained by or on behalf of
such person in any format (including paper and electronic
formats) and at any location.''.
(b) Conforming Amendment.--Section 704(a)(1)(B) (21 U.S.C.
374(a)(1)(B)) is amended by striking ``section 414 when'' and
all that follows through ``subject to'' and inserting
``section 414, when the standard for records inspection under
paragraph (1) or (2) of section 414(a) applies, subject to''.
SEC. 102. REGISTRATION OF FOOD FACILITIES.
(a) Updating of Food Category Regulations; Biennial
Registration Renewal.--Section 415(a) (21 U.S.C. 350d(a)) is
amended--
(1) in paragraph (2), by--
(A) striking ``conducts business and'' and inserting
``conducts business, the e-mail address for the contact
person of the facility or, in the case of a foreign facility,
the United States agent for the facility, and''; and
(B) inserting ``, or any other food categories as
determined appropriate by the Secretary, including by
guidance'' after ``Code of Federal Regulations'';
(2) by redesignating paragraphs (3) and (4) as paragraphs
(4) and (5), respectively; and
(3) by inserting after paragraph (2) the following:
``(3) Biennial registration renewal.--During the period
beginning on October 1 and ending on December 31 of each
even-numbered year, a registrant that has submitted a
registration under paragraph (1) shall submit to the
Secretary a renewal registration containing the information
described in paragraph (2). The Secretary shall provide for
an abbreviated registration renewal process for any
registrant that has not had any changes to such information
since the registrant submitted the preceding registration or
registration renewal for the facility involved.''.
(b) Suspension of Registration.--
(1) In general.--Section 415 (21 U.S.C. 350d) is amended--
(A) in subsection (a)(2), by inserting after the first
sentence the following: ``The registration shall contain an
assurance that the Secretary will be permitted to inspect
such facility at the times and in the manner permitted by
this Act.'';
(B) by redesignating subsections (b) and (c) as subsections
(c) and (d), respectively; and
(C) by inserting after subsection (a) the following:
``(b) Suspension of Registration.--
``(1) In general.--If the Secretary determines that food
manufactured, processed, packed, received, or held by a
facility registered under this section has a reasonable
probability of causing serious adverse health consequences or
death to humans or animals, the Secretary may by order
suspend the registration of a facility--
``(A) that created, caused, or was otherwise responsible
for such reasonable probability; or
``(B)(i) that knew of, or had reason to know of, such
reasonable probability; and
``(ii) packed, received, or held such food.
``(2) Hearing on suspension.--The Secretary shall provide
the registrant subject to an order under paragraph (1) with
an opportunity for an informal hearing, to be held as soon as
possible but not later than 2 business days after the
issuance of the order or such other time period, as agreed
upon by the Secretary and the registrant, on the actions
required for reinstatement of registration and why the
registration that is subject to suspension should be
reinstated. The Secretary shall reinstate a registration if
the Secretary determines, based on evidence presented, that
adequate grounds do not exist to continue the suspension of
the registration.
``(3) Post-hearing corrective action plan; vacating of
order.--
``(A) Corrective action plan.--If, after providing
opportunity for an informal hearing under paragraph (2), the
Secretary determines that the suspension of registration
remains necessary, the Secretary shall require the registrant
to submit a corrective action plan to demonstrate how the
registrant plans to correct the conditions found by the
Secretary. The Secretary shall review such plan not later
than 14 days after the submission of the corrective action
plan or such other time period as determined by the
Secretary.
``(B) Vacating of order.--Upon a determination by the
Secretary that adequate grounds do not exist to continue the
suspension actions required by the order, or that such
actions should be modified, the Secretary shall promptly
vacate the order and reinstate the registration of the
facility subject to the order or modify the order, as
appropriate.
``(4) Effect of suspension.--If the registration of a
facility is suspended under this subsection, no person shall
import or export food into the United States from such
facility, offer to import or export food into the United
States from such facility, or otherwise introduce food from
such facility into interstate or intrastate commerce in the
United States.
``(5) Regulations.--
``(A) In general.--The Secretary shall promulgate
regulations to implement this subsection. The Secretary may
promulgate such regulations on an interim final basis.
``(B) Registration requirement.--The Secretary may require
that registration under this section be submitted in an
electronic format. Such requirement may not take effect
before the date that is 5 years after the date of enactment
of the FDA Food Safety Modernization Act.
``(6) Application date.--Facilities shall be subject to the
requirements of this subsection beginning on the earlier of--
``(A) the date on which the Secretary issues regulations
under paragraph (5); or
``(B) 180 days after the date of enactment of the FDA Food
Safety Modernization Act.
``(7) No delegation.--The authority conferred by this
subsection to issue an order to suspend a registration or
vacate an order of suspension shall not be delegated to any
officer or employee other than the Commissioner.''.
(2) Small entity compliance policy guide.--Not later than
180 days after the issuance of the regulations promulgated
under section 415(b)(5) of the Federal Food, Drug, and
Cosmetic Act (as added by this section), the Secretary shall
issue a small entity compliance policy guide setting forth in
plain language the requirements of such regulations to assist
small entities in complying with registration requirements
and other activities required under such section.
(3) Imported food.--Section 801(l) (21 U.S.C. 381(l)) is
amended by inserting ``(or for which a registration has been
suspended under such section)'' after ``section 415''.
(c) Clarification of Intent.--
(1) Retail food establishment.--The Secretary shall amend
the definition of the term ``retail food establishment'' in
section in 1.227(b)(11) of title 21, Code of Federal
Regulations to clarify that, in determining the primary
function of an establishment or a retail food establishment
under such section, the sale of food products directly to
consumers by such establishment and the sale of food directly
to consumers by such retail food establishment include--
(A) the sale of such food products or food directly to
consumers by such establishment at a roadside stand or
farmers' market where such stand or market is located other
than where the food was manufactured or processed;
[[Page H8863]]
(B) the sale and distribution of such food through a
community supported agriculture program; and
(C) the sale and distribution of such food at any other
such direct sales platform as determined by the Secretary.
(2) Definitions.--For purposes of paragraph (1)--
(A) the term ``community supported agriculture program''
has the same meaning given the term ``community supported
agriculture (CSA) program'' in section 249.2 of title 7, Code
of Federal Regulations (or any successor regulation); and
(B) the term ``consumer'' does not include a business.
(d) Conforming Amendments.--
(1) Section 301(d) (21 U.S.C. 331(d)) is amended by
inserting ``415,'' after ``404,''.
(2) Section 415(d), as redesignated by subsection (b), is
amended by adding at the end before the period ``for a
facility to be registered, except with respect to the
reinstatement of a registration that is suspended under
subsection (b)''.
SEC. 103. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS.
(a) In General.--Chapter IV (21 U.S.C. 341 et seq.) is
amended by adding at the end the following:
``SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE
CONTROLS.
``(a) In General.--The owner, operator, or agent in charge
of a facility shall, in accordance with this section,
evaluate the hazards that could affect food manufactured,
processed, packed, or held by such facility, identify and
implement preventive controls to significantly minimize or
prevent the occurrence of such hazards and provide assurances
that such food is not adulterated under section 402 or
misbranded under section 403(w), monitor the performance of
those controls, and maintain records of this monitoring as a
matter of routine practice.
``(b) Hazard Analysis.--The owner, operator, or agent in
charge of a facility shall--
``(1) identify and evaluate known or reasonably foreseeable
hazards that may be associated with the facility, including--
``(A) biological, chemical, physical, and radiological
hazards, natural toxins, pesticides, drug residues,
decomposition, parasites, allergens, and unapproved food and
color additives; and
``(B) hazards that occur naturally, or may be
unintentionally introduced; and
``(2) identify and evaluate hazards that may be
intentionally introduced, including by acts of terrorism; and
``(3) develop a written analysis of the hazards.
``(c) Preventive Controls.--The owner, operator, or agent
in charge of a facility shall identify and implement
preventive controls, including at critical control points, if
any, to provide assurances that--
``(1) hazards identified in the hazard analysis conducted
under subsection (b)(1) will be significantly minimized or
prevented;
``(2) any hazards identified in the hazard analysis
conducted under subsection (b)(2) will be significantly
minimized or prevented and addressed, consistent with section
420, as applicable; and
``(3) the food manufactured, processed, packed, or held by
such facility will not be adulterated under section 402 or
misbranded under section 403(w).
``(d) Monitoring of Effectiveness.--The owner, operator, or
agent in charge of a facility shall monitor the effectiveness
of the preventive controls implemented under subsection (c)
to provide assurances that the outcomes described in
subsection (c) shall be achieved.
``(e) Corrective Actions.--The owner, operator, or agent in
charge of a facility shall establish procedures to ensure
that, if the preventive controls implemented under subsection
(c) are not properly implemented or are found to be
ineffective--
``(1) appropriate action is taken to reduce the likelihood
of recurrence of the implementation failure;
``(2) all affected food is evaluated for safety; and
``(3) all affected food is prevented from entering into
commerce if the owner, operator or agent in charge of such
facility cannot ensure that the affected food is not
adulterated under section 402 or misbranded under section
403(w).
``(f) Verification.--The owner, operator, or agent in
charge of a facility shall verify that--
``(1) the preventive controls implemented under subsection
(c) are adequate to control the hazards identified under
subsection (b);
``(2) the owner, operator, or agent is conducting
monitoring in accordance with subsection (d);
``(3) the owner, operator, or agent is making appropriate
decisions about corrective actions taken under subsection
(e);
``(4) the preventive controls implemented under subsection
(c) are effectively and significantly minimizing or
preventing the occurrence of identified hazards, including
through the use of environmental and product testing programs
and other appropriate means; and
``(5) there is documented, periodic reanalysis of the plan
under subsection (i) to ensure that the plan is still
relevant to the raw materials, conditions and processes in
the facility, and new and emerging threats.
``(g) Recordkeeping.--The owner, operator, or agent in
charge of a facility shall maintain, for not less than 2
years, records documenting the monitoring of the preventive
controls implemented under subsection (c), instances of
nonconformance material to food safety, the results of
testing and other appropriate means of verification under
subsection (f)(4), instances when corrective actions were
implemented, and the efficacy of preventive controls and
corrective actions.
``(h) Written Plan and Documentation.--The owner, operator,
or agent in charge of a facility shall prepare a written plan
that documents and describes the procedures used by the
facility to comply with the requirements of this section,
including analyzing the hazards under subsection (b) and
identifying the preventive controls adopted under subsection
(c) to address those hazards. Such written plan, together
with the documentation described in subsection (g), shall be
made promptly available to a duly authorized representative
of the Secretary upon oral or written request.
``(i) Requirement To Reanalyze.--The owner, operator, or
agent in charge of a facility shall conduct a reanalysis
under subsection (b) whenever a significant change is made in
the activities conducted at a facility operated by such
owner, operator, or agent if the change creates a reasonable
potential for a new hazard or a significant increase in a
previously identified hazard or not less frequently than once
every 3 years, whichever is earlier. Such reanalysis shall be
completed and additional preventive controls needed to
address the hazard identified, if any, shall be implemented
before the change in activities at the facility is operative.
Such owner, operator, or agent shall revise the written plan
required under subsection (h) if such a significant change is
made or document the basis for the conclusion that no
additional or revised preventive controls are needed. The
Secretary may require a reanalysis under this section to
respond to new hazards and developments in scientific
understanding, including, as appropriate, results from the
Department of Homeland Security biological, chemical,
radiological, or other terrorism risk assessment.
``(j) Exemption for Seafood, Juice, and Low-acid Canned
Food Facilities Subject to HACCP.--
``(1) In general.--This section shall not apply to a
facility if the owner, operator, or agent in charge of such
facility is required to comply with, and is in compliance
with, 1 of the following standards and regulations with
respect to such facility:
``(A) The Seafood Hazard Analysis Critical Control Points
Program of the Food and Drug Administration.
``(B) The Juice Hazard Analysis Critical Control Points
Program of the Food and Drug Administration.
``(C) The Thermally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers standards of the Food and Drug
Administration (or any successor standards).
``(2) Applicability.--The exemption under paragraph (1)(C)
shall apply only with respect to microbiological hazards that
are regulated under the standards for Thermally Processed
Low-Acid Foods Packaged in Hermetically Sealed Containers
under part 113 of chapter 21, Code of Federal Regulations (or
any successor regulations).
``(k) Exception for Activities of Facilities Subject to
Section 419.--This section shall not apply to activities of a
facility that are subject to section 419.
``(l) Modified Requirements for Qualified Facilities.--
``(1) Qualified facilities.--
``(A) In general.--A facility is a qualified facility for
purposes of this subsection if the facility meets the
conditions under subparagraph (B) or (C).
``(B) Very small business.--A facility is a qualified
facility under this subparagraph--
``(i) if the facility, including any subsidiary or
affiliate of the facility, is, collectively, a very small
business (as defined in the regulations promulgated under
subsection (n)); and
``(ii) in the case where the facility is a subsidiary or
affiliate of an entity, if such subsidiaries or affiliates,
are, collectively, a very small business (as so defined).
``(C) Limited annual monetary value of sales.--
``(i) In general.--A facility is a qualified facility under
this subparagraph if clause (ii) applies--
``(I) to the facility, including any subsidiary or
affiliate of the facility, collectively; and
``(II) to the subsidiaries or affiliates, collectively, of
any entity of which the facility is a subsidiary or
affiliate.
``(ii) Average annual monetary value.--This clause applies
if--
``(I) during the 3-year period preceding the applicable
calendar year, the average annual monetary value of the food
manufactured, processed, packed, or held at such facility (or
the collective average annual monetary value of such food at
any subsidiary or affiliate, as described in clause (i)) that
is sold directly to qualified end-users during such period
exceeded the average annual monetary value of the food
manufactured, processed, packed, or held at such facility (or
the collective average annual monetary value of such food at
any subsidiary or affiliate, as so described) sold by such
facility (or collectively by any such subsidiary or
affiliate) to all other purchasers during such period; and
``(II) the average annual monetary value of all food sold
by such facility (or the collective average annual monetary
value of such food sold by any subsidiary or affiliate, as
described in clause (i)) during such period was less than
$500,000, adjusted for inflation.
``(2) Exemption.--A qualified facility--
``(A) shall not be subject to the requirements under
subsections (a) through (i) and subsection (n) in an
applicable calendar year; and
``(B) shall submit to the Secretary--
``(i)(I) documentation that demonstrates that the owner,
operator, or agent in charge of the facility has identified
potential hazards associated with the food being produced, is
implementing preventive controls to address the hazards, and
is monitoring the preventive controls to ensure that such
controls are effective; or
``(II) documentation (which may include licenses,
inspection reports, certificates, permits,
[[Page H8864]]
credentials, certification by an appropriate agency (such as
a State department of agriculture), or other evidence of
oversight), as specified by the Secretary, that the facility
is in compliance with State, local, county, or other
applicable non-Federal food safety law; and
``(ii) documentation, as specified by the Secretary in a
guidance document issued not later than 1 year after the date
of enactment of this section, that the facility is a
qualified facility under paragraph (1)(B) or (1)(C).
``(3) Withdrawal; rule of construction.--
``(A) In general.--In the event of an active investigation
of a foodborne illness outbreak that is directly linked to a
qualified facility subject to an exemption under this
subsection, or if the Secretary determines that it is
necessary to protect the public health and prevent or
mitigate a foodborne illness outbreak based on conduct or
conditions associated with a qualified facility that are
material to the safety of the food manufactured, processed,
packed, or held at such facility, the Secretary may withdraw
the exemption provided to such facility under this
subsection.
``(B) Rule of construction.--Nothing in this subsection
shall be construed to expand or limit the inspection
authority of the Secretary.
``(4) Definitions.--In this subsection:
``(A) Affiliate.--The term `affiliate' means any facility
that controls, is controlled by, or is under common control
with another facility.
``(B) Qualified end-user.--The term `qualified end-user',
with respect to a food, means--
``(i) the consumer of the food; or
``(ii) a restaurant or retail food establishment (as those
terms are defined by the Secretary for purposes of section
415) that--
``(I) is located--
``(aa) in the same State as the qualified facility that
sold the food to such restaurant or establishment; or
``(bb) not more than 275 miles from such facility; and
``(II) is purchasing the food for sale directly to
consumers at such restaurant or retail food establishment.
``(C) Consumer.--For purposes of subparagraph (B), the term
`consumer' does not include a business.
``(D) Subsidiary.--The term `subsidiary' means any company
which is owned or controlled directly or indirectly by
another company.
``(5) Study.--
``(A) In general.--The Secretary, in consultation with the
Secretary of Agriculture, shall conduct a study of the food
processing sector regulated by the Secretary to determine--
``(i) the distribution of food production by type and size
of operation, including monetary value of food sold;
``(ii) the proportion of food produced by each type and
size of operation;
``(iii) the number and types of food facilities co-located
on farms, including the number and proportion by commodity
and by manufacturing or processing activity;
``(iv) the incidence of foodborne illness originating from
each size and type of operation and the type of food
facilities for which no reported or known hazard exists; and
``(v) the effect on foodborne illness risk associated with
commingling, processing, transporting, and storing food and
raw agricultural commodities, including differences in risk
based on the scale and duration of such activities.
``(B) Size.--The results of the study conducted under
subparagraph (A) shall include the information necessary to
enable the Secretary to define the terms `small business' and
`very small business', for purposes of promulgating the
regulation under subsection (n). In defining such terms, the
Secretary shall include consideration of harvestable acres,
income, the number of employees, and the volume of food
harvested.
``(C) Submission of report.--Not later than 18 months after
the date of enactment the FDA Food Safety Modernization Act,
the Secretary shall submit to Congress a report that
describes the results of the study conducted under
subparagraph (A).
``(6) No preemption.--Nothing in this subsection preempts
State, local, county, or other non-Federal law regarding the
safe production of food. Compliance with this subsection
shall not relieve any person from liability at common law or
under State statutory law.
``(7) Notification to consumers.--
``(A) In general.--A qualified facility that is exempt from
the requirements under subsections (a) through (i) and
subsection (n) and does not prepare documentation under
paragraph (2)(B)(i)(I) shall--
``(i) with respect to a food for which a food packaging
label is required by the Secretary under any other provision
of this Act, include prominently and conspicuously on such
label the name and business address of the facility where the
food was manufactured or processed; or
``(ii) with respect to a food for which a food packaging
label is not required by the Secretary under any other
provisions of this Act, prominently and conspicuously
display, at the point of purchase, the name and business
address of the facility where the food was manufactured or
processed, on a label, poster, sign, placard, or documents
delivered contemporaneously with the food in the normal
course of business, or, in the case of Internet sales, in an
electronic notice.
``(B) No additional label.--Subparagraph (A) does not
provide authority to the Secretary to require a label that is
in addition to any label required under any other provision
of this Act.
``(m) Authority With Respect to Certain Facilities.--The
Secretary may, by regulation, exempt or modify the
requirements for compliance under this section with respect
to facilities that are solely engaged in the production of
food for animals other than man, the storage of raw
agricultural commodities (other than fruits and vegetables)
intended for further distribution or processing, or the
storage of packaged foods that are not exposed to the
environment.
``(n) Regulations.--
``(1) In general.--Not later than 18 months after the date
of enactment of the FDA Food Safety Modernization Act, the
Secretary shall promulgate regulations--
``(A) to establish science-based minimum standards for
conducting a hazard analysis, documenting hazards,
implementing preventive controls, and documenting the
implementation of the preventive controls under this section;
and
``(B) to define, for purposes of this section, the terms
`small business' and `very small business', taking into
consideration the study described in subsection (l)(5).
``(2) Coordination.--In promulgating the regulations under
paragraph (1)(A), with regard to hazards that may be
intentionally introduced, including by acts of terrorism, the
Secretary shall coordinate with the Secretary of Homeland
Security, as appropriate.
``(3) Content.--The regulations promulgated under paragraph
(1)(A) shall--
``(A) provide sufficient flexibility to be practicable for
all sizes and types of facilities, including small businesses
such as a small food processing facility co-located on a
farm;
``(B) comply with chapter 35 of title 44, United States
Code (commonly known as the `Paperwork Reduction Act'), with
special attention to minimizing the burden (as defined in
section 3502(2) of such Act) on the facility, and collection
of information (as defined in section 3502(3) of such Act),
associated with such regulations;
``(C) acknowledge differences in risk and minimize, as
appropriate, the number of separate standards that apply to
separate foods; and
``(D) not require a facility to hire a consultant or other
third party to identify, implement, certify, or audit
preventative controls, except in the case of negotiated
enforcement resolutions that may require such a consultant or
third party.
``(4) Rule of construction.--Nothing in this subsection
shall be construed to provide the Secretary with the
authority to prescribe specific technologies, practices, or
critical controls for an individual facility.
``(5) Review.--In promulgating the regulations under
paragraph (1)(A), the Secretary shall review regulatory
hazard analysis and preventive control programs in existence
on the date of enactment of the FDA Food Safety Modernization
Act, including the Grade `A' Pasteurized Milk Ordinance to
ensure that such regulations are consistent, to the extent
practicable, with applicable domestic and internationally-
recognized standards in existence on such date.
``(o) Definitions.--For purposes of this section:
``(1) Critical control point.--The term `critical control
point' means a point, step, or procedure in a food process at
which control can be applied and is essential to prevent or
eliminate a food safety hazard or reduce such hazard to an
acceptable level.
``(2) Facility.--The term `facility' means a domestic
facility or a foreign facility that is required to register
under section 415.
``(3) Preventive controls.--The term `preventive controls'
means those risk-based, reasonably appropriate procedures,
practices, and processes that a person knowledgeable about
the safe manufacturing, processing, packing, or holding of
food would employ to significantly minimize or prevent the
hazards identified under the hazard analysis conducted under
subsection (b) and that are consistent with the current
scientific understanding of safe food manufacturing,
processing, packing, or holding at the time of the analysis.
Those procedures, practices, and processes may include the
following:
``(A) Sanitation procedures for food contact surfaces and
utensils and food-contact surfaces of equipment.
``(B) Supervisor, manager, and employee hygiene training.
``(C) An environmental monitoring program to verify the
effectiveness of pathogen controls in processes where a food
is exposed to a potential contaminant in the environment.
``(D) A food allergen control program.
``(E) A recall plan.
``(F) Current Good Manufacturing Practices (cGMPs) under
part 110 of title 21, Code of Federal Regulations (or any
successor regulations).
``(G) Supplier verification activities that relate to the
safety of food.''.
(b) Guidance Document.--The Secretary shall issue a
guidance document related to the regulations promulgated
under subsection (b)(1) with respect to the hazard analysis
and preventive controls under section 418 of the Federal
Food, Drug, and Cosmetic Act (as added by subsection (a)).
(c) Rulemaking.--
(1) Proposed rulemaking.--
(A) In general.--Not later than 9 months after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this subsection as the
``Secretary'') shall publish a notice of proposed rulemaking
in the Federal Register to promulgate regulations with
respect to--
(i) activities that constitute on-farm packing or holding
of food that is not grown, raised, or consumed on such farm
or another farm under the same ownership for purposes of
section 415 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 350d), as amended by this Act; and
(ii) activities that constitute on-farm manufacturing or
processing of food that is not consumed on that farm or on
another farm under common ownership for purposes of such
section 415.
(B) Clarification.--The rulemaking described under
subparagraph (A) shall enhance the implementation of such
section 415 and clarify the activities that are included as
part of the
[[Page H8865]]
definition of the term ``facility'' under such section 415.
Nothing in this Act authorizes the Secretary to modify the
definition of the term ``facility'' under such section.
(C) Science-based risk analysis.--In promulgating
regulations under subparagraph (A), the Secretary shall
conduct a science-based risk analysis of--
(i) specific types of on-farm packing or holding of food
that is not grown, raised, or consumed on such farm or
another farm under the same ownership, as such packing and
holding relates to specific foods; and
(ii) specific on-farm manufacturing and processing
activities as such activities relate to specific foods that
are not consumed on that farm or on another farm under common
ownership.
(D) Authority with respect to certain facilities.--
(i) In general.--In promulgating the regulations under
subparagraph (A), the Secretary shall consider the results of
the science-based risk analysis conducted under subparagraph
(C), and shall exempt certain facilities from the
requirements in section 418 of the Federal Food, Drug, and
Cosmetic Act (as added by this section), including hazard
analysis and preventive controls, and the mandatory
inspection frequency in section 421 of such Act (as added by
section 201), or modify the requirements in such sections 418
or 421, as the Secretary determines appropriate, if such
facilities are engaged only in specific types of on-farm
manufacturing, processing, packing, or holding activities
that the Secretary determines to be low risk involving
specific foods the Secretary determines to be low risk.
(ii) Limitation.--The exemptions or modifications under
clause (i) shall not include an exemption from the
requirement to register under section 415 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by
this Act, if applicable, and shall apply only to small
businesses and very small businesses, as defined in the
regulation promulgated under section 418(n) of the Federal
Food, Drug, and Cosmetic Act (as added under subsection (a)).
(2) Final regulations.--Not later than 9 months after the
close of the comment period for the proposed rulemaking under
paragraph (1), the Secretary shall adopt final rules with
respect to--
(A) activities that constitute on-farm packing or holding
of food that is not grown, raised, or consumed on such farm
or another farm under the same ownership for purposes of
section 415 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 350d), as amended by this Act;
(B) activities that constitute on-farm manufacturing or
processing of food that is not consumed on that farm or on
another farm under common ownership for purposes of such
section 415; and
(C) the requirements under sections 418 and 421 of the
Federal Food, Drug, and Cosmetic Act, as added by this Act,
from which the Secretary may issue exemptions or
modifications of the requirements for certain types of
facilities.
(d) Small Entity Compliance Policy Guide.--Not later than
180 days after the issuance of the regulations promulgated
under subsection (n) of section 418 of the Federal Food,
Drug, and Cosmetic Act (as added by subsection (a)), the
Secretary shall issue a small entity compliance policy guide
setting forth in plain language the requirements of such
section 418 and this section to assist small entities in
complying with the hazard analysis and other activities
required under such section 418 and this section.
(e) Prohibited Acts.--Section 301 (21 U.S.C. 331) is
amended by adding at the end the following:
``(uu) The operation of a facility that manufactures,
processes, packs, or holds food for sale in the United States
if the owner, operator, or agent in charge of such facility
is not in compliance with section 418.''.
(f) No Effect on HACCP Authorities.--Nothing in the
amendments made by this section limits the authority of the
Secretary under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) or the Public Health Service Act (42
U.S.C. 201 et seq.) to revise, issue, or enforce Hazard
Analysis Critical Control programs and the Thermally
Processed Low-Acid Foods Packaged in Hermetically Sealed
Containers standards.
(g) Dietary Supplements.--Nothing in the amendments made by
this section shall apply to any facility with regard to the
manufacturing, processing, packing, or holding of a dietary
supplement that is in compliance with the requirements of
sections 402(g)(2) and 761 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 342(g)(2), 379aa-1).
(h) Updating Guidance Relating to Fish and Fisheries
Products Hazards and Controls.--The Secretary shall, not
later than 180 days after the date of enactment of this Act,
update the Fish and Fisheries Products Hazards and Control
Guidance to take into account advances in technology that
have occurred since the previous publication of such Guidance
by the Secretary.
(i) Effective Dates.--
(1) General rule.--The amendments made by this section
shall take effect 18 months after the date of enactment of
this Act.
(2) Flexibility for small businesses.--Notwithstanding
paragraph (1)--
(A) the amendments made by this section shall apply to a
small business (as defined in the regulations promulgated
under section 418(n) of the Federal Food, Drug, and Cosmetic
Act (as added by this section)) beginning on the date that is
6 months after the effective date of such regulations; and
(B) the amendments made by this section shall apply to a
very small business (as defined in such regulations)
beginning on the date that is 18 months after the effective
date of such regulations.
SEC. 104. PERFORMANCE STANDARDS.
(a) In General.--The Secretary shall, in coordination with
the Secretary of Agriculture, not less frequently than every
2 years, review and evaluate relevant health data and other
relevant information, including from toxicological and
epidemiological studies and analyses, current Good
Manufacturing Practices issued by the Secretary relating to
food, and relevant recommendations of relevant advisory
committees, including the Food Advisory Committee, to
determine the most significant foodborne contaminants.
(b) Guidance Documents and Regulations.--Based on the
review and evaluation conducted under subsection (a), and
when appropriate to reduce the risk of serious illness or
death to humans or animals or to prevent adulteration of the
food under section 402 of the Federal Food, Drug, or Cosmetic
Act (21 U.S.C. 342) or to prevent the spread by food of
communicable disease under section 361 of the Public Health
Service Act (42 U.S.C. 264), the Secretary shall issue
contaminant-specific and science-based guidance documents,
including guidance documents regarding action levels, or
regulations. Such guidance, including guidance regarding
action levels, or regulations--
(1) shall apply to products or product classes;
(2) shall, where appropriate, differentiate between food
for human consumption and food intended for consumption by
animals other than humans; and
(3) shall not be written to be facility-specific.
(c) No Duplication of Efforts.--The Secretary shall
coordinate with the Secretary of Agriculture to avoid issuing
duplicative guidance on the same contaminants.
(d) Review.--The Secretary shall periodically review and
revise, as appropriate, the guidance documents, including
guidance documents regarding action levels, or regulations
promulgated under this section.
SEC. 105. STANDARDS FOR PRODUCE SAFETY.
(a) In General.--Chapter IV (21 U.S.C. 341 et seq.), as
amended by section 103, is amended by adding at the end the
following:
``SEC. 419. STANDARDS FOR PRODUCE SAFETY.
``(a) Proposed Rulemaking.--
``(1) In general.--
``(A) Rulemaking.--Not later than 1 year after the date of
enactment of the FDA Food Safety Modernization Act, the
Secretary, in coordination with the Secretary of Agriculture
and representatives of State departments of agriculture
(including with regard to the national organic program
established under the Organic Foods Production Act of 1990),
and in consultation with the Secretary of Homeland Security,
shall publish a notice of proposed rulemaking to establish
science-based minimum standards for the safe production and
harvesting of those types of fruits and vegetables, including
specific mixes or categories of fruits and vegetables, that
are raw agricultural commodities for which the Secretary has
determined that such standards minimize the risk of serious
adverse health consequences or death.
``(B) Determination by secretary.--With respect to small
businesses and very small businesses (as such terms are
defined in the regulation promulgated under subparagraph (A))
that produce and harvest those types of fruits and vegetables
that are raw agricultural commodities that the Secretary has
determined are low risk and do not present a risk of serious
adverse health consequences or death, the Secretary may
determine not to include production and harvesting of such
fruits and vegetables in such rulemaking, or may modify the
applicable requirements of regulations promulgated pursuant
to this section.
``(2) Public input.--During the comment period on the
notice of proposed rulemaking under paragraph (1), the
Secretary shall conduct not less than 3 public meetings in
diverse geographical areas of the United States to provide
persons in different regions an opportunity to comment.
``(3) Content.--The proposed rulemaking under paragraph (1)
shall--
``(A) provide sufficient flexibility to be applicable to
various types of entities engaged in the production and
harvesting of fruits and vegetables that are raw agricultural
commodities, including small businesses and entities that
sell directly to consumers, and be appropriate to the scale
and diversity of the production and harvesting of such
commodities;
``(B) include, with respect to growing, harvesting,
sorting, packing, and storage operations, science-based
minimum standards related to soil amendments, hygiene,
packaging, temperature controls, animals in the growing area,
and water;
``(C) consider hazards that occur naturally, may be
unintentionally introduced, or may be intentionally
introduced, including by acts of terrorism;
``(D) take into consideration, consistent with ensuring
enforceable public health protection, conservation and
environmental practice standards and policies established by
Federal natural resource conservation, wildlife conservation,
and environmental agencies;
``(E) in the case of production that is certified organic,
not include any requirements that conflict with or duplicate
the requirements of the national organic program established
under the Organic Foods Production Act of 1990, while
providing the same level of public health protection as the
requirements under guidance documents, including guidance
documents regarding action levels, and regulations under the
FDA Food Safety Modernization Act; and
``(F) define, for purposes of this section, the terms
`small business' and `very small business'
``(4) Prioritization.--The Secretary shall prioritize the
implementation of the regulations under this section for
specific fruits and vegetables that are raw agricultural
commodities based
[[Page H8866]]
on known risks which may include a history and severity of
foodborne illness outbreaks.
``(b) Final Regulation.--
``(1) In general.--Not later than 1 year after the close of
the comment period for the proposed rulemaking under
subsection (a), the Secretary shall adopt a final regulation
to provide for minimum science-based standards for those
types of fruits and vegetables, including specific mixes or
categories of fruits or vegetables, that are raw agricultural
commodities, based on known safety risks, which may include a
history of foodborne illness outbreaks.
``(2) Final regulation.--The final regulation shall--
``(A) provide for coordination of education and enforcement
activities by State and local officials, as designated by the
Governors of the respective States or the appropriate elected
State official as recognized by State statute; and
``(B) include a description of the variance process under
subsection (c) and the types of permissible variances the
Secretary may grant.
``(3) Flexibility for small businesses.--Notwithstanding
paragraph (1)--
``(A) the regulations promulgated under this section shall
apply to a small business (as defined in the regulation
promulgated under subsection (a)(1)) after the date that is 1
year after the effective date of the final regulation under
paragraph (1); and
``(B) the regulations promulgated under this section shall
apply to a very small business (as defined in the regulation
promulgated under subsection (a)(1)) after the date that is 2
years after the effective date of the final regulation under
paragraph (1).
``(c) Criteria.--
``(1) In general.--The regulations adopted under subsection
(b) shall--
``(A) set forth those procedures, processes, and practices
that the Secretary determines to minimize the risk of serious
adverse health consequences or death, including procedures,
processes, and practices that the Secretary determines to be
reasonably necessary to prevent the introduction of known or
reasonably foreseeable biological, chemical, and physical
hazards, including hazards that occur naturally, may be
unintentionally introduced, or may be intentionally
introduced, including by acts of terrorism, into fruits and
vegetables, including specific mixes or categories of fruits
and vegetables, that are raw agricultural commodities and to
provide reasonable assurances that the produce is not
adulterated under section 402;
``(B) provide sufficient flexibility to be practicable for
all sizes and types of businesses, including small businesses
such as a small food processing facility co-located on a
farm;
``(C) comply with chapter 35 of title 44, United States
Code (commonly known as the `Paperwork Reduction Act'), with
special attention to minimizing the burden (as defined in
section 3502(2) of such Act) on the business, and collection
of information (as defined in section 3502(3) of such Act),
associated with such regulations;
``(D) acknowledge differences in risk and minimize, as
appropriate, the number of separate standards that apply to
separate foods; and
``(E) not require a business to hire a consultant or other
third party to identify, implement, certify, compliance with
these procedures, processes, and practices, except in the
case of negotiated enforcement resolutions that may require
such a consultant or third party; and
``(F) permit States and foreign countries from which food
is imported into the United States to request from the
Secretary variances from the requirements of the regulations,
subject to paragraph (2), where the State or foreign country
determines that the variance is necessary in light of local
growing conditions and that the procedures, processes, and
practices to be followed under the variance are reasonably
likely to ensure that the produce is not adulterated under
section 402 and to provide the same level of public health
protection as the requirements of the regulations adopted
under subsection (b).
``(2) Variances.--
``(A) Requests for variances.--A State or foreign country
from which food is imported into the United States may in
writing request a variance from the Secretary. Such request
shall describe the variance requested and present information
demonstrating that the variance does not increase the
likelihood that the food for which the variance is requested
will be adulterated under section 402, and that the variance
provides the same level of public health protection as the
requirements of the regulations adopted under subsection (b).
The Secretary shall review such requests in a reasonable
timeframe.
``(B) Approval of variances.--The Secretary may approve a
variance in whole or in part, as appropriate, and may specify
the scope of applicability of a variance to other similarly
situated persons.
``(C) Denial of variances.--The Secretary may deny a
variance request if the Secretary determines that such
variance is not reasonably likely to ensure that the food is
not adulterated under section 402 and is not reasonably
likely to provide the same level of public health protection
as the requirements of the regulation adopted under
subsection (b). The Secretary shall notify the person
requesting such variance of the reasons for the denial.
``(D) Modification or revocation of a variance.--The
Secretary, after notice and an opportunity for a hearing, may
modify or revoke a variance if the Secretary determines that
such variance is not reasonably likely to ensure that the
food is not adulterated under section 402 and is not
reasonably likely to provide the same level of public health
protection as the requirements of the regulations adopted
under subsection (b).
``(d) Enforcement.--The Secretary may coordinate with the
Secretary of Agriculture and, as appropriate, shall contract
and coordinate with the agency or department designated by
the Governor of each State to perform activities to ensure
compliance with this section.
``(e) Guidance.--
``(1) In general.--Not later than 1 year after the date of
enactment of the FDA Food Safety Modernization Act, the
Secretary shall publish, after consultation with the
Secretary of Agriculture, representatives of State
departments of agriculture, farmer representatives, and
various types of entities engaged in the production and
harvesting or importing of fruits and vegetables that are raw
agricultural commodities, including small businesses, updated
good agricultural practices and guidance for the safe
production and harvesting of specific types of fresh produce
under this section.
``(2) Public meetings.--The Secretary shall conduct not
fewer than 3 public meetings in diverse geographical areas of
the United States as part of an effort to conduct education
and outreach regarding the guidance described in paragraph
(1) for persons in different regions who are involved in the
production and harvesting of fruits and vegetables that are
raw agricultural commodities, including persons that sell
directly to consumers and farmer representatives, and for
importers of fruits and vegetables that are raw agricultural
commodities.
``(3) Paperwork reduction.--The Secretary shall ensure that
any updated guidance under this section will--
``(A) provide sufficient flexibility to be practicable for
all sizes and types of facilities, including small businesses
such as a small food processing facility co-located on a
farm; and
``(B) acknowledge differences in risk and minimize, as
appropriate, the number of separate standards that apply to
separate foods.
``(f) Exemption for Direct Farm Marketing.--
``(1) In general.--A farm shall be exempt from the
requirements under this section in a calendar year if--
``(A) during the previous 3-year period, the average annual
monetary value of the food sold by such farm directly to
qualified end-users during such period exceeded the average
annual monetary value of the food sold by such farm to all
other buyers during such period; and
``(B) the average annual monetary value of all food sold
during such period was less than $500,000, adjusted for
inflation.
``(2) Notification to consumers.--
``(A) In general.--A farm that is exempt from the
requirements under this section shall--
``(i) with respect to a food for which a food packaging
label is required by the Secretary under any other provision
of this Act, include prominently and conspicuously on such
label the name and business address of the farm where the
produce was grown; or
``(ii) with respect to a food for which a food packaging
label is not required by the Secretary under any other
provision of this Act, prominently and conspicuously display,
at the point of purchase, the name and business address of
the farm where the produce was grown, on a label, poster,
sign, placard, or documents delivered contemporaneously with
the food in the normal course of business, or, in the case of
Internet sales, in an electronic notice.
``(B) No additional label.--Subparagraph (A) does not
provide authority to the Secretary to require a label that is
in addition to any label required under any other provision
of this Act.
``(3) Withdrawal; rule of construction.--
``(A) In general.--In the event of an active investigation
of a foodborne illness outbreak that is directly linked to a
farm subject to an exemption under this subsection, or if the
Secretary determines that it is necessary to protect the
public health and prevent or mitigate a foodborne illness
outbreak based on conduct or conditions associated with a
farm that are material to the safety of the food produced or
harvested at such farm, the Secretary may withdraw the
exemption provided to such farm under this subsection.
``(B) Rule of construction.--Nothing in this subsection
shall be construed to expand or limit the inspection
authority of the Secretary.
``(4) Definitions.--
``(A) Qualified end-user.--In this subsection, the term
`qualified end-user', with respect to a food means--
``(i) the consumer of the food; or
``(ii) a restaurant or retail food establishment (as those
terms are defined by the Secretary for purposes of section
415) that is located--
``(I) in the same State as the farm that produced the food;
or
``(II) not more than 275 miles from such farm.
``(B) Consumer.--For purposes of subparagraph (A), the term
`consumer' does not include a business.
``(5) No preemption.--Nothing in this subsection preempts
State, local, county, or other non-Federal law regarding the
safe production, harvesting, holding, transportation, and
sale of fresh fruits and vegetables. Compliance with this
subsection shall not relieve any person from liability at
common law or under State statutory law.
``(6) Limitation of effect.--Nothing in this subsection
shall prevent the Secretary from exercising any authority
granted in the other sections of this Act.
``(g) Clarification.--This section shall not apply to
produce that is produced by an individual for personal
consumption.
``(h) Exception for Activities of Facilities Subject to
Section 418.--This section shall not apply to activities of a
facility that are subject to section 418.''.
(b) Small Entity Compliance Policy Guide.--Not later than
180 days after the issuance of regulations under section 419
of the Federal Food, Drug, and Cosmetic Act (as added by
subsection (a)), the Secretary of Health and Human Services
shall issue a small entity compliance policy guide setting
forth in plain language the requirements of such section 419
and to assist small entities in complying with standards for
safe production and harvesting and other activities required
under such section.
[[Page H8867]]
(c) Prohibited Acts.--Section 301 (21 U.S.C. 331), as
amended by section 103, is amended by adding at the end the
following:
``(vv) The failure to comply with the requirements under
section 419.''.
(d) No Effect on HACCP Authorities.--Nothing in the
amendments made by this section limits the authority of the
Secretary under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) or the Public Health Service Act (42
U.S.C. 201 et seq.) to revise, issue, or enforce product and
category-specific regulations, such as the Seafood Hazard
Analysis Critical Controls Points Program, the Juice Hazard
Analysis Critical Control Program, and the Thermally
Processed Low-Acid Foods Packaged in Hermetically Sealed
Containers standards.
SEC. 106. PROTECTION AGAINST INTENTIONAL ADULTERATION.
(a) In General.--Chapter IV (21 U.S.C. 341 et seq.), as
amended by section 105, is amended by adding at the end the
following:
``SEC. 420. PROTECTION AGAINST INTENTIONAL ADULTERATION.
``(a) Determinations.--
``(1) In general.--The Secretary shall--
``(A) conduct a vulnerability assessment of the food
system, including by consideration of the Department of
Homeland Security biological, chemical, radiological, or
other terrorism risk assessments;
``(B) consider the best available understanding of
uncertainties, risks, costs, and benefits associated with
guarding against intentional adulteration of food at
vulnerable points; and
``(C) determine the types of science-based mitigation
strategies or measures that are necessary to protect against
the intentional adulteration of food.
``(2) Limited distribution.--In the interest of national
security, the Secretary, in consultation with the Secretary
of Homeland Security, may determine the time, manner, and
form in which determinations made under paragraph (1) are
made publicly available.
``(b) Regulations.--Not later than 18 months after the date
of enactment of the FDA Food Safety Modernization Act, the
Secretary, in coordination with the Secretary of Homeland
Security and in consultation with the Secretary of
Agriculture, shall promulgate regulations to protect against
the intentional adulteration of food subject to this Act.
Such regulations shall--
``(1) specify how a person shall assess whether the person
is required to implement mitigation strategies or measures
intended to protect against the intentional adulteration of
food; and
``(2) specify appropriate science-based mitigation
strategies or measures to prepare and protect the food supply
chain at specific vulnerable points, as appropriate.
``(c) Applicability.--Regulations promulgated under
subsection (b) shall apply only to food for which there is a
high risk of intentional contamination, as determined by the
Secretary, in consultation with the Secretary of Homeland
Security, under subsection (a), that could cause serious
adverse health consequences or death to humans or animals and
shall include those foods--
``(1) for which the Secretary has identified clear
vulnerabilities (including short shelf-life or susceptibility
to intentional contamination at critical control points); and
``(2) in bulk or batch form, prior to being packaged for
the final consumer.
``(d) Exception.--This section shall not apply to farms,
except for those that produce milk.
``(e) Definition.--For purposes of this section, the term
`farm' has the meaning given that term in section 1.227 of
title 21, Code of Federal Regulations (or any successor
regulation).''.
(b) Guidance Documents.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services, in consultation with the Secretary of Homeland
Security and the Secretary of Agriculture, shall issue
guidance documents related to protection against the
intentional adulteration of food, including mitigation
strategies or measures to guard against such adulteration as
required under section 420 of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a).
(2) Content.--The guidance documents issued under paragraph
(1) shall--
(A) include a model assessment for a person to use under
subsection (b)(1) of section 420 of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a);
(B) include examples of mitigation strategies or measures
described in subsection (b)(2) of such section; and
(C) specify situations in which the examples of mitigation
strategies or measures described in subsection (b)(2) of such
section are appropriate.
(3) Limited distribution.--In the interest of national
security, the Secretary of Health and Human Services, in
consultation with the Secretary of Homeland Security, may
determine the time, manner, and form in which the guidance
documents issued under paragraph (1) are made public,
including by releasing such documents to targeted audiences.
(c) Periodic Review.--The Secretary of Health and Human
Services shall periodically review and, as appropriate,
update the regulations under section 420(b) of the Federal
Food, Drug, and Cosmetic Act, as added by subsection (a), and
the guidance documents under subsection (b).
(d) Prohibited Acts.--Section 301 (21 U.S.C. 331 et seq.),
as amended by section 105, is amended by adding at the end
the following:
``(ww) The failure to comply with section 420.''.
SEC. 107. AUTHORITY TO COLLECT FEES.
(a) Fees for Reinspection, Recall, and Importation
Activities.--Subchapter C of chapter VII (21 U.S.C. 379f et
seq.) is amended by adding at the end the following:
``PART 6--FEES RELATED TO FOOD
``SEC. 743. AUTHORITY TO COLLECT AND USE FEES.
``(a) In General.--
``(1) Purpose and authority.--For fiscal year 2010 and each
subsequent fiscal year, the Secretary shall, in accordance
with this section, assess and collect fees from--
``(A) the responsible party for each domestic facility (as
defined in section 415(b)) and the United States agent for
each foreign facility subject to a reinspection in such
fiscal year, to cover reinspection-related costs for such
year;
``(B) the responsible party for a domestic facility (as
defined in section 415(b)) and an importer who does not
comply with a recall order under section 423 or under section
412(f) in such fiscal year, to cover food recall activities
associated with such order performed by the Secretary,
including technical assistance, follow-up effectiveness
checks, and public notifications, for such year;
``(C) each importer participating in the voluntary
qualified importer program under section 806 in such year, to
cover the administrative costs of such program for such year;
and
``(D) each importer subject to a reinspection in such
fiscal year, to cover reinspection-related costs for such
year.
``(2) Definitions.--For purposes of this section--
``(A) the term `reinspection' means--
``(i) with respect to domestic facilities (as defined in
section 415(b)), 1 or more inspections conducted under
section 704 subsequent to an inspection conducted under such
provision which identified noncompliance materially related
to a food safety requirement of this Act, specifically to
determine whether compliance has been achieved to the
Secretary's satisfaction; and
``(ii) with respect to importers, 1 or more examinations
conducted under section 801 subsequent to an examination
conducted under such provision which identified noncompliance
materially related to a food safety requirement of this Act,
specifically to determine whether compliance has been
achieved to the Secretary's satisfaction;
``(B) the term `reinspection-related costs' means all
expenses, including administrative expenses, incurred in
connection with--
``(i) arranging, conducting, and evaluating the results of
reinspections; and
``(ii) assessing and collecting reinspection fees under
this section; and
``(C) the term `responsible party' has the meaning given
such term in section 417(a)(1).
``(b) Establishment of Fees.--
``(1) In general.--Subject to subsections (c) and (d), the
Secretary shall establish the fees to be collected under this
section for each fiscal year specified in subsection (a)(1),
based on the methodology described under paragraph (2), and
shall publish such fees in a Federal Register notice not
later than 60 days before the start of each such year.
``(2) Fee methodology.--
``(A) Fees.--Fees amounts established for collection--
``(i) under subparagraph (A) of subsection (a)(1) for a
fiscal year shall be based on the Secretary's estimate of 100
percent of the costs of the reinspection-related activities
(including by type or level of reinspection activity, as the
Secretary determines applicable) described in such
subparagraph (A) for such year;
``(ii) under subparagraph (B) of subsection (a)(1) for a
fiscal year shall be based on the Secretary's estimate of 100
percent of the costs of the activities described in such
subparagraph (B) for such year;
``(iii) under subparagraph (C) of subsection (a)(1) for a
fiscal year shall be based on the Secretary's estimate of 100
percent of the costs of the activities described in such
subparagraph (C) for such year; and
``(iv) under subparagraph (D) of subsection (a)(1) for a
fiscal year shall be based on the Secretary's estimate of 100
percent of the costs of the activities described in such
subparagraph (D) for such year.
``(B) Other considerations.--
``(i) Voluntary qualified importer program.--In
establishing the fee amounts under subparagraph (A)(iii) for
a fiscal year, the Secretary shall provide for the number of
importers who have submitted to the Secretary a notice under
section 806(c) informing the Secretary of the intent of such
importer to participate in the program under section 806 in
such fiscal year.
``(II) Recoupment.--In establishing the fee amounts under
subparagraph (A)(iii) for the first 5 fiscal years after the
date of enactment of this section, the Secretary shall
include in such fee a reasonable surcharge that provides a
recoupment of the costs expended by the Secretary to
establish and implement the first year of the program under
section 806.
``(ii) Crediting of fees.--In establishing the fee amounts
under subparagraph (A) for a fiscal year, the Secretary shall
provide for the crediting of fees from the previous year to
the next year if the Secretary overestimated the amount of
fees needed to carry out such activities, and consider the
need to account for any adjustment of fees and such other
factors as the Secretary determines appropriate.
``(iii) Published guidelines.--Not later than 180 days
after the date of enactment of the FDA Food Safety
Modernization Act, the Secretary shall publish in the Federal
Register a proposed set of guidelines in consideration of the
burden of fee amounts on small business. Such consideration
may include reduced fee amounts for small businesses. The
Secretary shall provide for a period of public comment on
such guidelines. The Secretary shall adjust the fee schedule
for small businesses subject to such fees only through notice
and comment rulemaking.
[[Page H8868]]
``(3) Use of fees.--The Secretary shall make all of the
fees collected pursuant to clause (i), (ii), (iii), and (iv)
of paragraph (2)(A) available solely to pay for the costs
referred to in such clause (i), (ii), (iii), and (iv) of
paragraph (2)(A), respectively.
``(c) Limitations.--
``(1) In general.--Fees under subsection (a) shall be
refunded for a fiscal year beginning after fiscal year 2010
unless the amount of the total appropriations for food safety
activities at the Food and Drug Administration for such
fiscal year (excluding the amount of fees appropriated for
such fiscal year) is equal to or greater than the amount of
appropriations for food safety activities at the Food and
Drug Administration for fiscal year 2009 (excluding the
amount of fees appropriated for such fiscal year), multiplied
by the adjustment factor under paragraph (3).
``(2) Authority.--If--
``(A) the Secretary does not assess fees under subsection
(a) for a portion of a fiscal year because paragraph (1)
applies; and
``(B) at a later date in such fiscal year, such paragraph
(1) ceases to apply,
the Secretary may assess and collect such fees under
subsection (a), without any modification to the rate of such
fees, notwithstanding the provisions of subsection (a)
relating to the date fees are to be paid.
``(3) Adjustment factor.--
``(A) In general.--The adjustment factor described in
paragraph (1) shall be the total percentage change that
occurred in the Consumer Price Index for all urban consumers
(all items; United States city average) for the 12-month
period ending June 30 preceding the fiscal year, but in no
case shall such adjustment factor be negative.
``(B) Compounded basis.--The adjustment under subparagraph
(A) made each fiscal year shall be added on a compounded
basis to the sum of all adjustments made each fiscal year
after fiscal year 2009.
``(4) Limitation on amount of certain fees.--
``(A) In general.--Notwithstanding any other provision of
this section and subject to subparagraph (B), the Secretary
may not collect fees in a fiscal year such that the amount
collected--
``(i) under subparagraph (B) of subsection (a)(1) exceeds
$20,000,000; and
``(ii) under subparagraphs (A) and (D) of subsection (a)(1)
exceeds $25,000,000 combined.
``(B) Exception.--If a domestic facility (as defined in
section 415(b)) or an importer becomes subject to a fee
described in subparagraph (A), (B), or (D) of subsection
(a)(1) after the maximum amount of fees has been collected by
the Secretary under subparagraph (A), the Secretary may
collect a fee from such facility or importer.
``(d) Crediting and Availability of Fees.--Fees authorized
under subsection (a) shall be collected and available for
obligation only to the extent and in the amount provided in
appropriations Acts. Such fees are authorized to remain
available until expended. Such sums as may be necessary may
be transferred from the Food and Drug Administration salaries
and expenses account without fiscal year limitation to such
appropriation account for salaries and expenses with such
fiscal year limitation. The sums transferred shall be
available solely for the purpose of paying the operating
expenses of the Food and Drug Administration employees and
contractors performing activities associated with these food
safety fees.
``(e) Collection of Fees.--
``(1) In general.--The Secretary shall specify in the
Federal Register notice described in subsection (b)(1) the
time and manner in which fees assessed under this section
shall be collected.
``(2) Collection of unpaid fees.--In any case where the
Secretary does not receive payment of a fee assessed under
this section within 30 days after it is due, such fee shall
be treated as a claim of the United States Government subject
to provisions of subchapter II of chapter 37 of title 31,
United States Code.
``(f) Annual Report to Congress.--Not later than 120 days
after each fiscal year for which fees are assessed under this
section, the Secretary shall submit a report to the Committee
on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of
Representatives, to include a description of fees assessed
and collected for each such year and a summary description of
the entities paying such fees and the types of business in
which such entities engage.
``(g) Authorization of Appropriations.--For fiscal year
2010 and each fiscal year thereafter, there is authorized to
be appropriated for fees under this section an amount equal
to the total revenue amount determined under subsection (b)
for the fiscal year, as adjusted or otherwise affected under
the other provisions of this section.''.
(b) Export Certification Fees for Foods and Animal Feed.--
(1) Authority for export certifications for food, including
animal feed.--Section 801(e)(4)(A) (21 U.S.C. 381(e)(4)(A))
is amended--
(A) in the matter preceding clause (i), by striking ``a
drug'' and inserting ``a food, drug'';
(B) in clause (i) by striking ``exported drug'' and
inserting ``exported food, drug''; and
(C) in clause (ii) by striking ``the drug'' each place it
appears and inserting ``the food, drug''.
(2) Clarification of certification.--Section 801(e)(4) (21
U.S.C. 381(e)(4)) is amended by inserting after subparagraph
(B) the following new subparagraph:
``(C) For purposes of this paragraph, a certification by
the Secretary shall be made on such basis, and in such form
(including a publicly available listing) as the Secretary
determines appropriate.''.
(3) Limitations on the use and amount of fees.--Paragraph
(4) of section 801(e) (21 U.S.C. 381(e)) is amended by adding
at the end the following:
``(D) With regard to fees pursuant to subparagraph (B) in
connection with written export certifications for food:
``(i) Such fees shall be collected and available solely for
the costs of the Food and Drug Administration associated with
issuing such certifications.
``(ii) Such fees may not be retained in an amount that
exceeds such costs for the respective fiscal year.''
SEC. 108. NATIONAL AGRICULTURE AND FOOD DEFENSE STRATEGY.
(a) Development and Submission of Strategy.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services and the Secretary of Agriculture, in coordination
with the Secretary of Homeland Security, shall prepare and
transmit to the relevant committees of Congress, and make
publicly available on the Internet Web sites of the
Department of Health and Human Services and the Department of
Agriculture, the National Agriculture and Food Defense
Strategy.
(2) Implementation plan.--The strategy shall include an
implementation plan for use by the Secretaries described
under paragraph (1) in carrying out the strategy.
(3) Research.--The strategy shall include a coordinated
research agenda for use by the Secretaries described under
paragraph (1) in conducting research to support the goals and
activities described in paragraphs (1) and (2) of subsection
(b).
(4) Revisions.--Not later than 4 years after the date on
which the strategy is submitted to the relevant committees of
Congress under paragraph (1), and not less frequently than
every 4 years thereafter, the Secretary of Health and Human
Services and the Secretary of Agriculture, in coordination
with the Secretary of Homeland Security, shall revise and
submit to the relevant committees of Congress the strategy.
(5) Consistency with existing plans.--The strategy
described in paragraph (1) shall be consistent with--
(A) the National Incident Management System;
(B) the National Response Framework;
(C) the National Infrastructure Protection Plan;
(D) the National Preparedness Goals; and
(E) other relevant national strategies.
(b) Components.--
(1) In general.--The strategy shall include a description
of the process to be used by the Department of Health and
Human Services, the Department of Agriculture, and the
Department of Homeland Security--
(A) to achieve each goal described in paragraph (2); and
(B) to evaluate the progress made by Federal, State, local,
and tribal governments towards the achievement of each goal
described in paragraph (2).
(2) Goals.--The strategy shall include a description of the
process to be used by the Department of Health and Human
Services, the Department of Agriculture, and the Department
of Homeland Security to achieve the following goals:
(A) Preparedness goal.--Enhance the preparedness of the
agriculture and food system by--
(i) conducting vulnerability assessments of the agriculture
and food system;
(ii) mitigating vulnerabilities of the system;
(iii) improving communication and training relating to the
system;
(iv) developing and conducting exercises to test
decontamination and disposal plans;
(v) developing modeling tools to improve event consequence
assessment and decision support; and
(vi) preparing risk communication tools and enhancing
public awareness through outreach.
(B) Detection goal.--Improve agriculture and food system
detection capabilities by--
(i) identifying contamination in food products at the
earliest possible time; and
(ii) conducting surveillance to prevent the spread of
diseases.
(C) Emergency response goal.--Ensure an efficient response
to agriculture and food emergencies by--
(i) immediately investigating animal disease outbreaks and
suspected food contamination;
(ii) preventing additional human illnesses;
(iii) organizing, training, and equipping animal, plant,
and food emergency response teams of--
(I) the Federal Government; and
(II) State, local, and tribal governments;
(iv) designing, developing, and evaluating training and
exercises carried out under agriculture and food defense
plans; and
(v) ensuring consistent and organized risk communication to
the public by--
(I) the Federal Government;
(II) State, local, and tribal governments; and
(III) the private sector.
(D) Recovery goal.--Secure agriculture and food production
after an agriculture or food emergency by--
(i) working with the private sector to develop business
recovery plans to rapidly resume agriculture, food
production, and international trade;
(ii) conducting exercises of the plans described in
subparagraph (C) with the goal of long-term recovery results;
(iii) rapidly removing, and effectively disposing of--
(I) contaminated agriculture and food products; and
(II) infected plants and animals; and
[[Page H8869]]
(iv) decontaminating and restoring areas affected by an
agriculture or food emergency.
(3) Evaluation.--The Secretary, in coordination with the
Secretary of Agriculture and the Secretary of Homeland
Security, shall--
(A) develop metrics to measure progress for the evaluation
process described in paragraph (1)(B); and
(B) report on the progress measured in subparagraph (A) as
part of the National Agriculture and Food Defense strategy
described in subsection (a)(1).
(c) Limited Distribution.--In the interest of national
security, the Secretary of Health and Human Services and the
Secretary of Agriculture, in coordination with the Secretary
of Homeland Security, may determine the manner and format in
which the National Agriculture and Food Defense strategy
established under this section is made publicly available on
the Internet Web sites of the Department of Health and Human
Services, the Department of Homeland Security, and the
Department of Agriculture, as described in subsection (a)(1).
SEC. 109. FOOD AND AGRICULTURE COORDINATING COUNCILS.
The Secretary of Homeland Security, in coordination with
the Secretary of Health and Human Services and the Secretary
of Agriculture, shall within 180 days of enactment of this
Act, and annually thereafter, submit to the relevant
committees of Congress, and make publicly available on the
Internet Web site of the Department of Homeland Security, a
report on the activities of the Food and Agriculture
Government Coordinating Council and the Food and Agriculture
Sector Coordinating Council, including the progress of such
Councils on--
(1) facilitating partnerships between public and private
entities to help coordinate and enhance the protection of the
agriculture and food system of the United States;
(2) providing for the regular and timely interchange of
information between each council relating to the security of
the agriculture and food system (including intelligence
information);
(3) identifying best practices and methods for improving
the coordination among Federal, State, local, and private
sector preparedness and response plans for agriculture and
food defense; and
(4) recommending methods by which to protect the economy
and the public health of the United States from the effects
of--
(A) animal or plant disease outbreaks;
(B) food contamination; and
(C) natural disasters affecting agriculture and food.
SEC. 110. BUILDING DOMESTIC CAPACITY.
(a) In General.--
(1) Initial report.--The Secretary, in coordination with
the Secretary of Agriculture and the Secretary of Homeland
Security, shall, not later than 2 years after the date of
enactment of this Act, submit to Congress a comprehensive
report that identifies programs and practices that are
intended to promote the safety and supply chain security of
food and to prevent outbreaks of foodborne illness and other
food-related hazards that can be addressed through preventive
activities. Such report shall include a description of the
following:
(A) Analysis of the need for further regulations or
guidance to industry.
(B) Outreach to food industry sectors, including through
the Food and Agriculture Coordinating Councils referred to in
section 109, to identify potential sources of emerging
threats to the safety and security of the food supply and
preventive strategies to address those threats.
(C) Systems to ensure the prompt distribution to the food
industry of information and technical assistance concerning
preventive strategies.
(D) Communication systems to ensure that information about
specific threats to the safety and security of the food
supply are rapidly and effectively disseminated.
(E) Surveillance systems and laboratory networks to rapidly
detect and respond to foodborne illness outbreaks and other
food-related hazards, including how such systems and networks
are integrated.
(F) Outreach, education, and training provided to States
and local governments to build State and local food safety
and food defense capabilities, including progress
implementing strategies developed under sections 108 and 205.
(G) The estimated resources needed to effectively implement
the programs and practices identified in the report developed
in this section over a 5-year period.
(H) The impact of requirements under this Act (including
amendments made by this Act) on certified organic farms and
facilities (as defined in section 415 (21 U.S.C. 350d).
(I) Specific efforts taken pursuant to the agreements
authorized under section 421(c) of the Federal Food, Drug,
and Cosmetic Act (as added by section 201), together with, as
necessary, a description of any additional authorities
necessary to improve seafood safety.
(2) Biennial reports.--On a biennial basis following the
submission of the report under paragraph (1), the Secretary
shall submit to Congress a report that--
(A) reviews previous food safety programs and practices;
(B) outlines the success of those programs and practices;
(C) identifies future programs and practices; and
(D) includes information related to any matter described in
subparagraphs (A) through (H) of paragraph (1), as necessary.
(b) Risk-based Activities.--The report developed under
subsection (a)(1) shall describe methods that seek to ensure
that resources available to the Secretary for food safety-
related activities are directed at those actions most likely
to reduce risks from food, including the use of preventive
strategies and allocation of inspection resources. The
Secretary shall promptly undertake those risk-based actions
that are identified during the development of the report as
likely to contribute to the safety and security of the food
supply.
(c) Capability for Laboratory Analyses; Research.--The
report developed under subsection (a)(1) shall provide a
description of methods to increase capacity to undertake
analyses of food samples promptly after collection, to
identify new and rapid analytical techniques, including
commercially-available techniques that can be employed at
ports of entry and by Food Emergency Response Network
laboratories, and to provide for well-equipped and staffed
laboratory facilities and progress toward laboratory
accreditation under section 422 of the Federal Food, Drug,
and Cosmetic Act (as added by section 202).
(d) Information Technology.--The report developed under
subsection (a)(1) shall include a description of such
information technology systems as may be needed to identify
risks and receive data from multiple sources, including
foreign governments, State, local, and tribal governments,
other Federal agencies, the food industry, laboratories,
laboratory networks, and consumers. The information
technology systems that the Secretary describes shall also
provide for the integration of the facility registration
system under section 415 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 350d), and the prior notice system
under section 801(m) of such Act (21 U.S.C. 381(m)) with
other information technology systems that are used by the
Federal Government for the processing of food offered for
import into the United States.
(e) Automated Risk Assessment.--The report developed under
subsection (a)(1) shall include a description of progress
toward developing and improving an automated risk assessment
system for food safety surveillance and allocation of
resources.
(f) Traceback and Surveillance Report.--The Secretary shall
include in the report developed under subsection (a)(1) an
analysis of the Food and Drug Administration's performance in
foodborne illness outbreaks during the 5-year period
preceding the date of enactment of this Act involving fruits
and vegetables that are raw agricultural commodities (as
defined in section 201(r) (21 U.S.C. 321(r)) and
recommendations for enhanced surveillance, outbreak response,
and traceability. Such findings and recommendations shall
address communication and coordination with the public,
industry, and State and local governments, as such
communication and coordination relates to outbreak
identification and traceback.
(g) Biennial Food Safety and Food Defense Research Plan.--
The Secretary, the Secretary of Agriculture, and the
Secretary of Homeland Security shall, on a biennial basis,
submit to Congress a joint food safety and food defense
research plan which may include studying the long-term health
effects of foodborne illness. Such biennial plan shall
include a list and description of projects conducted during
the previous 2-year period and the plan for projects to be
conducted during the subsequent 2-year period.
(h) Effectiveness of Programs Administered by the
Department of Health and Human Services.--
(1) In general.--To determine whether existing Federal
programs administered by the Department of Health and Human
Services are effective in achieving the stated goals of such
programs, the Secretary shall, beginning not later than 1
year after the date of enactment of this Act--
(A) conduct an annual evaluation of each program of such
Department to determine the effectiveness of each such
program in achieving legislated intent, purposes, and
objectives; and
(B) submit to Congress a report concerning such evaluation.
(2) Content.--The report described under paragraph (1)(B)
shall--
(A) include conclusions concerning the reasons that such
existing programs have proven successful or not successful
and what factors contributed to such conclusions;
(B) include recommendations for consolidation and
elimination to reduce duplication and inefficiencies in such
programs at such Department as identified during the
evaluation conduct under this subsection; and
(C) be made publicly available in a publication entitled
``Guide to the U.S. Department of Health and Human Services
Programs''.
(i) Unique Identification Numbers.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary, acting through the
Commissioner of Food and Drugs, shall conduct a study
regarding the need for, and challenges associated with,
development and implementation of a program that requires a
unique identification number for each food facility
registered with the Secretary and, as appropriate, each
broker that imports food into the United States. Such study
shall include an evaluation of the costs associated with
development and implementation of such a system, and make
recommendations about what new authorities, if any, would be
necessary to develop and implement such a system.
(2) Report.--Not later than 15 months after the date of
enactment of this Act, the Secretary shall submit to Congress
a report that describes the findings of the study conducted
under paragraph (1) and that includes any recommendations
determined appropriate by the Secretary.
SEC. 111. SANITARY TRANSPORTATION OF FOOD.
(a) In General.--Not later than 18 months after the date of
enactment of this Act, the Secretary shall promulgate
regulations described in section 416(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 350e(b)).
(b) Food Transportation Study.--The Secretary, acting
through the Commissioner of Food and Drugs, shall conduct a
study of the
[[Page H8870]]
transportation of food for consumption in the United States,
including transportation by air, that includes an examination
of the unique needs of rural and frontier areas with regard
to the delivery of safe food.
SEC. 112. FOOD ALLERGY AND ANAPHYLAXIS MANAGEMENT.
(a) Definitions.--In this section:
(1) Early childhood education program.--The term ``early
childhood education program'' means--
(A) a Head Start program or an Early Head Start program
carried out under the Head Start Act (42 U.S.C. 9831 et
seq.);
(B) a State licensed or regulated child care program or
school; or
(C) a State prekindergarten program that serves children
from birth through kindergarten.
(2) ESEA definitions.--The terms ``local educational
agency'', ``secondary school'', ``elementary school'', and
``parent'' have the meanings given the terms in section 9101
of the Elementary and Secondary Education Act of 1965 (20
U.S.C. 7801).
(3) School.--The term ``school'' includes public--
(A) kindergartens;
(B) elementary schools; and
(C) secondary schools.
(4) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(b) Establishment of Voluntary Food Allergy and Anaphylaxis
Management Guidelines.--
(1) Establishment.--
(A) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary, in consultation with
the Secretary of Education, shall--
(i) develop guidelines to be used on a voluntary basis to
develop plans for individuals to manage the risk of food
allergy and anaphylaxis in schools and early childhood
education programs; and
(ii) make such guidelines available to local educational
agencies, schools, early childhood education programs, and
other interested entities and individuals to be implemented
on a voluntary basis only.
(B) Applicability of ferpa.--Each plan described in
subparagraph (A) that is developed for an individual shall be
considered an education record for the purpose of section 444
of the General Education Provisions Act (commonly referred to
as the ``Family Educational Rights and Privacy Act of 1974'')
(20 U.S.C. 1232g).
(2) Contents.--The voluntary guidelines developed by the
Secretary under paragraph (1) shall address each of the
following and may be updated as the Secretary determines
necessary:
(A) Parental obligation to provide the school or early
childhood education program, prior to the start of every
school year, with--
(i) documentation from their child's physician or nurse--
(I) supporting a diagnosis of food allergy, and any risk of
anaphylaxis, if applicable;
(II) identifying any food to which the child is allergic;
(III) describing, if appropriate, any prior history of
anaphylaxis;
(IV) listing any medication prescribed for the child for
the treatment of anaphylaxis;
(V) detailing emergency treatment procedures in the event
of a reaction;
(VI) listing the signs and symptoms of a reaction; and
(VII) assessing the child's readiness for self-
administration of prescription medication; and
(ii) a list of substitute meals that may be offered to the
child by school or early childhood education program food
service personnel.
(B) The creation and maintenance of an individual plan for
food allergy management, in consultation with the parent,
tailored to the needs of each child with a documented risk
for anaphylaxis, including any procedures for the self-
administration of medication by such children in instances
where--
(i) the children are capable of self-administering
medication; and
(ii) such administration is not prohibited by State law.
(C) Communication strategies between individual schools or
early childhood education programs and providers of emergency
medical services, including appropriate instructions for
emergency medical response.
(D) Strategies to reduce the risk of exposure to
anaphylactic causative agents in classrooms and common school
or early childhood education program areas such as
cafeterias.
(E) The dissemination of general information on life-
threatening food allergies to school or early childhood
education program staff, parents, and children.
(F) Food allergy management training of school or early
childhood education program personnel who regularly come into
contact with children with life-threatening food allergies.
(G) The authorization and training of school or early
childhood education program personnel to administer
epinephrine when the nurse is not immediately available.
(H) The timely accessibility of epinephrine by school or
early childhood education program personnel when the nurse is
not immediately available.
(I) The creation of a plan contained in each individual
plan for food allergy management that addresses the
appropriate response to an incident of anaphylaxis of a child
while such child is engaged in extracurricular programs of a
school or early childhood education program, such as non-
academic outings and field trips, before- and after-school
programs or before- and after-early child education program
programs, and school-sponsored or early childhood education
program-sponsored programs held on weekends.
(J) Maintenance of information for each administration of
epinephrine to a child at risk for anaphylaxis and prompt
notification to parents.
(K) Other elements the Secretary determines necessary for
the management of food allergies and anaphylaxis in schools
and early childhood education programs.
(3) Relation to state law.--Nothing in this section or the
guidelines developed by the Secretary under paragraph (1)
shall be construed to preempt State law, including any State
law regarding whether students at risk for anaphylaxis may
self-administer medication.
(c) School-based Food Allergy Management Grants.--
(1) In general.--The Secretary may award grants to local
educational agencies to assist such agencies with
implementing voluntary food allergy and anaphylaxis
management guidelines described in subsection (b).
(2) Application.--
(A) In general.--To be eligible to receive a grant under
this subsection, a local educational agency shall submit an
application to the Secretary at such time, in such manner,
and including such information as the Secretary may
reasonably require.
(B) Contents.--Each application submitted under
subparagraph (A) shall include--
(i) an assurance that the local educational agency has
developed plans in accordance with the food allergy and
anaphylaxis management guidelines described in subsection
(b);
(ii) a description of the activities to be funded by the
grant in carrying out the food allergy and anaphylaxis
management guidelines, including--
(I) how the guidelines will be carried out at individual
schools served by the local educational agency;
(II) how the local educational agency will inform parents
and students of the guidelines in place;
(III) how school nurses, teachers, administrators, and
other school-based staff will be made aware of, and given
training on, when applicable, the guidelines in place; and
(IV) any other activities that the Secretary determines
appropriate;
(iii) an itemization of how grant funds received under this
subsection will be expended;
(iv) a description of how adoption of the guidelines and
implementation of grant activities will be monitored; and
(v) an agreement by the local educational agency to report
information required by the Secretary to conduct evaluations
under this subsection.
(3) Use of funds.--Each local educational agency that
receives a grant under this subsection may use the grant
funds for the following:
(A) Purchase of materials and supplies, including limited
medical supplies such as epinephrine and disposable wet
wipes, to support carrying out the food allergy and
anaphylaxis management guidelines described in subsection
(b).
(B) In partnership with local health departments, school
nurse, teacher, and personnel training for food allergy
management.
(C) Programs that educate students as to the presence of,
and policies and procedures in place related to, food
allergies and anaphylactic shock.
(D) Outreach to parents.
(E) Any other activities consistent with the guidelines
described in subsection (b).
(4) Duration of awards.--The Secretary may award grants
under this subsection for a period of not more than 2 years.
In the event the Secretary conducts a program evaluation
under this subsection, funding in the second year of the
grant, where applicable, shall be contingent on a successful
program evaluation by the Secretary after the first year.
(5) Limitation on grant funding.--The Secretary may not
provide grant funding to a local educational agency under
this subsection after such local educational agency has
received 2 years of grant funding under this subsection.
(6) Maximum amount of annual awards.--A grant awarded under
this subsection may not be made in an amount that is more
than $50,000 annually.
(7) Priority.--In awarding grants under this subsection,
the Secretary shall give priority to local educational
agencies with the highest percentages of children who are
counted under section 1124(c) of the Elementary and Secondary
Education Act of 1965 (20 U.S.C. 6333(c)).
(8) Matching funds.--
(A) In general.--The Secretary may not award a grant under
this subsection unless the local educational agency agrees
that, with respect to the costs to be incurred by such local
educational agency in carrying out the grant activities, the
local educational agency shall make available (directly or
through donations from public or private entities) non-
Federal funds toward such costs in an amount equal to not
less than 25 percent of the amount of the grant.
(B) Determination of amount of non-federal contribution.--
Non-Federal funds required under subparagraph (A) may be cash
or in kind, including plant, equipment, or services. Amounts
provided by the Federal Government, and any portion of any
service subsidized by the Federal Government, may not be
included in determining the amount of such non-Federal funds.
(9) Administrative funds.--A local educational agency that
receives a grant under this subsection may use not more than
2 percent of the grant amount for administrative costs
related to carrying out this subsection.
(10) Progress and evaluations.--At the completion of the
grant period referred to in paragraph (4), a local
educational agency shall provide the Secretary with
information on how grant funds were spent and the status of
implementation of the food allergy and anaphylaxis
[[Page H8871]]
management guidelines described in subsection (b).
(11) Supplement, not supplant.--Grant funds received under
this subsection shall be used to supplement, and not
supplant, non-Federal funds and any other Federal funds
available to carry out the activities described in this
subsection.
(12) Authorization of appropriations.--There is authorized
to be appropriated to carry out this subsection $30,000,000
for fiscal year 2011 and such sums as may be necessary for
each of the 4 succeeding fiscal years.
(d) Voluntary Nature of Guidelines.--
(1) In general.--The food allergy and anaphylaxis
management guidelines developed by the Secretary under
subsection (b) are voluntary. Nothing in this section or the
guidelines developed by the Secretary under subsection (b)
shall be construed to require a local educational agency to
implement such guidelines.
(2) Exception.--Notwithstanding paragraph (1), the
Secretary may enforce an agreement by a local educational
agency to implement food allergy and anaphylaxis management
guidelines as a condition of the receipt of a grant under
subsection (c).
SEC. 113. NEW DIETARY INGREDIENTS.
(a) In General.--Section 413 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 350b) is amended--
(1) by redesignating subsection (c) as subsection (d); and
(2) by inserting after subsection (b) the following:
``(c) Notification.--
``(1) In general.--If the Secretary determines that the
information in a new dietary ingredient notification
submitted under this section for an article purported to be a
new dietary ingredient is inadequate to establish that a
dietary supplement containing such article will reasonably be
expected to be safe because the article may be, or may
contain, an anabolic steroid or an analogue of an anabolic
steroid, the Secretary shall notify the Drug Enforcement
Administration of such determination. Such notification by
the Secretary shall include, at a minimum, the name of the
dietary supplement or article, the name of the person or
persons who marketed the product or made the submission of
information regarding the article to the Secretary under this
section, and any contact information for such person or
persons that the Secretary has.
``(2) Definitions.--For purposes of this subsection--
``(A) the term `anabolic steroid' has the meaning given
such term in section 102(41) of the Controlled Substances
Act; and
``(B) the term `analogue of an anabolic steroid' means a
substance whose chemical structure is substantially similar
to the chemical structure of an anabolic steroid.''.
(b) Guidance.--Not later than 180 days after the date of
enactment of this Act, the Secretary shall publish guidance
that clarifies when a dietary supplement ingredient is a new
dietary ingredient, when the manufacturer or distributor of a
dietary ingredient or dietary supplement should provide the
Secretary with information as described in section 413(a)(2)
of the Federal Food, Drug, and Cosmetic Act, the evidence
needed to document the safety of new dietary ingredients, and
appropriate methods for establishing the identify of a new
dietary ingredient.
SEC. 114. REQUIREMENT FOR GUIDANCE RELATING TO POST HARVEST
PROCESSING OF RAW OYSTERS.
(a) In General.--Not later than 90 days prior to the
issuance of any guidance, regulation, or suggested amendment
by the Food and Drug Administration to the National Shellfish
Sanitation Program's Model Ordinance, or the issuance of any
guidance or regulation by the Food and Drug Administration
relating to the Seafood Hazard Analysis Critical Control
Points Program of the Food and Drug Administration (parts 123
and 1240 of title 21, Code of Federal Regulations (or any
successor regulations), where such guidance, regulation or
suggested amendment relates to post harvest processing for
raw oysters, the Secretary shall prepare and submit to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House
of Representatives a report which shall include--
(1) an assessment of how post harvest processing or other
equivalent controls feasibly may be implemented in the
fastest, safest, and most economical manner;
(2) the projected public health benefits of any proposed
post harvest processing;
(3) the projected costs of compliance with such post
harvest processing measures;
(4) the impact post harvest processing is expected to have
on the sales, cost, and availability of raw oysters;
(5) criteria for ensuring post harvest processing standards
will be applied equally to shellfish imported from all
nations of origin;
(6) an evaluation of alternative measures to prevent,
eliminate, or reduce to an acceptable level the occurrence of
foodborne illness; and
(7) the extent to which the Food and Drug Administration
has consulted with the States and other regulatory agencies,
as appropriate, with regard to post harvest processing
measures.
(b) Limitation.--Subsection (a) shall not apply to the
guidance described in section 103(h).
(c) Review and Evaluation.--Not later than 30 days after
the Secretary issues a proposed regulation or guidance
described in subsection (a), the Comptroller General of the
United States shall--
(1) review and evaluate the report described in (a) and
report to Congress on the findings of the estimates and
analysis in the report;
(2) compare such proposed regulation or guidance to similar
regulations or guidance with respect to other regulated
foods, including a comparison of risks the Secretary may find
associated with seafood and the instances of those risks in
such other regulated foods; and
(3) evaluate the impact of post harvest processing on the
competitiveness of the domestic oyster industry in the United
States and in international markets.
(d) Waiver.--The requirement of preparing a report under
subsection (a) shall be waived if the Secretary issues a
guidance that is adopted as a consensus agreement between
Federal and State regulators and the oyster industry, acting
through the Interstate Shellfish Sanitation Conference.
(e) Public Access.--Any report prepared under this section
shall be made available to the public.
SEC. 115. PORT SHOPPING.
Until the date on which the Secretary promulgates a final
rule that implements the amendments made by section 308 of
the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, (Public Law 107-188), the Secretary
shall notify the Secretary of Homeland Security of all
instances in which the Secretary refuses to admit a food into
the United States under section 801(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 381(a)) so that the
Secretary of Homeland Security, acting through the
Commissioner of Customs and Border Protection, may prevent
food refused admittance into the United States by a United
States port of entry from being admitted by another United
States port of entry, through the notification of other such
United States ports of entry.
SEC. 116. ALCOHOL-RELATED FACILITIES.
(a) In General.--Except as provided by sections 102, 206,
207, 302, 304, 402, 403, and 404 of this Act, and the
amendments made by such sections, nothing in this Act, or the
amendments made by this Act, shall be construed to apply to a
facility that--
(1) under the Federal Alcohol Administration Act (27 U.S.C.
201 et seq.) or chapter 51 of subtitle E of the Internal
Revenue Code of 1986 (26 U.S.C. 5001 et seq.) is required to
obtain a permit or to register with the Secretary of the
Treasury as a condition of doing business in the United
States; and
(2) under section 415 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 350d) is required to register as a
facility because such facility is engaged in manufacturing,
processing, packing, or holding 1 or more alcoholic
beverages, with respect to the activities of such facility
that relate to the manufacturing, processing, packing, or
holding of alcoholic beverages.
(b) Limited Receipt and Distribution of Non-alcohol Food.--
Subsection (a) shall not apply to a facility engaged in the
receipt and distribution of any non-alcohol food, except that
such paragraph shall apply to a facility described in such
paragraph that receives and distributes non-alcohol food,
provided such food is received and distributed--
(1) in a prepackaged form that prevents any direct human
contact with such food; and
(2) in amounts that constitute not more than 5 percent of
the overall sales of such facility, as determined by the
Secretary of the Treasury.
(c) Rule of Construction.--Except as provided in
subsections (a) and (b), this section shall not be construed
to exempt any food, other than alcoholic beverages, as
defined in section 214 of the Federal Alcohol Administration
Act (27 U.S.C. 214), from the requirements of this Act
(including the amendments made by this Act).
TITLE II--IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY
PROBLEMS
SEC. 201. TARGETING OF INSPECTION RESOURCES FOR DOMESTIC
FACILITIES, FOREIGN FACILITIES, AND PORTS OF
ENTRY; ANNUAL REPORT.
(a) Targeting of Inspection Resources for Domestic
Facilities, Foreign Facilities, and Ports of Entry.--Chapter
IV (21 U.S.C. 341 et seq.), as amended by section 106, is
amended by adding at the end the following:
``SEC. 421. TARGETING OF INSPECTION RESOURCES FOR DOMESTIC
FACILITIES, FOREIGN FACILITIES, AND PORTS OF
ENTRY; ANNUAL REPORT.
``(a) Identification and Inspection of Facilities.--
``(1) Identification.--The Secretary shall identify high-
risk facilities and shall allocate resources to inspect
facilities according to the known safety risks of the
facilities, which shall be based on the following factors:
``(A) The known safety risks of the food manufactured,
processed, packed, or held at the facility.
``(B) The compliance history of a facility, including with
regard to food recalls, outbreaks of foodborne illness, and
violations of food safety standards.
``(C) The rigor and effectiveness of the facility's hazard
analysis and risk-based preventive controls.
``(D) Whether the food manufactured, processed, packed, or
held at the facility meets the criteria for priority under
section 801(h)(1).
``(E) Whether the food or the facility that manufactured,
processed, packed, or held such food has received a
certification as described in section 801(q) or 806, as
appropriate.
``(F) Any other criteria deemed necessary and appropriate
by the Secretary for purposes of allocating inspection
resources.
``(2) Inspections.--
``(A) In general.--Beginning on the date of enactment of
the FDA Food Safety Modernization Act, the Secretary shall
increase the frequency of inspection of all facilities.
[[Page H8872]]
``(B) Domestic high-risk facilities.--The Secretary shall
increase the frequency of inspection of domestic facilities
identified under paragraph (1) as high-risk facilities such
that each such facility is inspected--
``(i) not less often than once in the 5-year period
following the date of enactment of the FDA Food Safety
Modernization Act; and
``(ii) not less often than once every 3 years thereafter.
``(C) Domestic non-high-risk facilities.--The Secretary
shall ensure that each domestic facility that is not
identified under paragraph (1) as a high-risk facility is
inspected--
``(i) not less often than once in the 7-year period
following the date of enactment of the FDA Food Safety
Modernization Act; and
``(ii) not less often than once every 5 years thereafter.
``(D) Foreign facilities.--
``(i) Year 1.--In the 1-year period following the date of
enactment of the FDA Food Safety Modernization Act, the
Secretary shall inspect not fewer than 600 foreign
facilities.
``(ii) Subsequent years.--In each of the 5 years following
the 1-year period described in clause (i), the Secretary
shall inspect not fewer than twice the number of foreign
facilities inspected by the Secretary during the previous
year.
``(E) Reliance on federal, state, or local inspections.--In
meeting the inspection requirements under this subsection for
domestic facilities, the Secretary may rely on inspections
conducted by other Federal, State, or local agencies under
interagency agreement, contract, memoranda of understanding,
or other obligation.
``(b) Identification and Inspection at Ports of Entry.--The
Secretary, in consultation with the Secretary of Homeland
Security, shall allocate resources to inspect any article of
food imported into the United States according to the known
safety risks of the article of food, which shall be based on
the following factors:
``(1) The known safety risks of the food imported.
``(2) The known safety risks of the countries or regions of
origin and countries through which such article of food is
transported.
``(3) The compliance history of the importer, including
with regard to food recalls, outbreaks of foodborne illness,
and violations of food safety standards.
``(4) The rigor and effectiveness of the activities
conducted by the importer of such article of food to satisfy
the requirements of the foreign supplier verification program
under section 805.
``(5) Whether the food importer participates in the
voluntary qualified importer program under section 806.
``(6) Whether the food meets the criteria for priority
under section 801(h)(1).
``(7) Whether the food or the facility that manufactured,
processed, packed, or held such food received a certification
as described in section 801(q) or 806.
``(8) Any other criteria deemed necessary and appropriate
by the Secretary for purposes of allocating inspection
resources.
``(c) Interagency Agreements With Respect to Seafood.--
``(1) In general.--The Secretary of Health and Human
Services, the Secretary of Commerce, the Secretary of
Homeland Security, the Chairman of the Federal Trade
Commission, and the heads of other appropriate agencies may
enter into such agreements as may be necessary or appropriate
to improve seafood safety.
``(2) Scope of agreements.--The agreements under paragraph
(1) may include--
``(A) cooperative arrangements for examining and testing
seafood imports that leverage the resources, capabilities,
and authorities of each party to the agreement;
``(B) coordination of inspections of foreign facilities to
increase the percentage of imported seafood and seafood
facilities inspected;
``(C) standardization of data on seafood names, inspection
records, and laboratory testing to improve interagency
coordination;
``(D) coordination to detect and investigate violations
under applicable Federal law;
``(E) a process, including the use or modification of
existing processes, by which officers and employees of the
National Oceanic and Atmospheric Administration may be duly
designated by the Secretary to carry out seafood examinations
and investigations under section 801 of this Act or section
203 of the Food Allergen Labeling and Consumer Protection Act
of 2004;
``(F) the sharing of information concerning observed non-
compliance with United States food requirements domestically
and in foreign nations and new regulatory decisions and
policies that may affect the safety of food imported into the
United States;
``(G) conducting joint training on subjects that affect and
strengthen seafood inspection effectiveness by Federal
authorities; and
``(H) outreach on Federal efforts to enhance seafood safety
and compliance with Federal food safety requirements.
``(d) Coordination.--The Secretary shall improve
coordination and cooperation with the Secretary of
Agriculture and the Secretary of Homeland Security to target
food inspection resources.
``(e) Facility.--For purposes of this section, the term
`facility' means a domestic facility or a foreign facility
that is required to register under section 415.''.
(b) Annual Report.--Section 1003 (21 U.S.C. 393) is amended
by adding at the end the following:
``(h) Annual Report Regarding Food.--Not later than
February 1 of each year, the Secretary shall submit to
Congress a report, including efforts to coordinate and
cooperate with other Federal agencies with responsibilities
for food inspections, regarding--
``(1) information about food facilities including--
``(A) the appropriations used to inspect facilities
registered pursuant to section 415 in the previous fiscal
year;
``(B) the average cost of both a non-high-risk food
facility inspection and a high-risk food facility inspection,
if such a difference exists, in the previous fiscal year;
``(C) the number of domestic facilities and the number of
foreign facilities registered pursuant to section 415 that
the Secretary inspected in the previous fiscal year;
``(D) the number of domestic facilities and the number of
foreign facilities registered pursuant to section 415 that
were scheduled for inspection in the previous fiscal year and
which the Secretary did not inspect in such year;
``(E) the number of high-risk facilities identified
pursuant to section 421 that the Secretary inspected in the
previous fiscal year; and
``(F) the number of high-risk facilities identified
pursuant to section 421 that were scheduled for inspection in
the previous fiscal year and which the Secretary did not
inspect in such year.
``(2) information about food imports including--
``(A) the number of lines of food imported into the United
States that the Secretary physically inspected or sampled in
the previous fiscal year;
``(B) the number of lines of food imported into the United
States that the Secretary did not physically inspect or
sample in the previous fiscal year; and
``(C) the average cost of physically inspecting or sampling
a line of food subject to this Act that is imported or
offered for import into the United States; and
``(3) information on the foreign offices of the Food and
Drug Administration including--
``(A) the number of foreign offices established; and
``(B) the number of personnel permanently stationed in each
foreign office.
``(i) Public Availability of Annual Food Reports.--The
Secretary shall make the reports required under subsection
(h) available to the public on the Internet Web site of the
Food and Drug Administration.''.
(c) Advisory Committee Consultation.--In allocating
inspection resources as described in section 421 of the
Federal Food, Drug, and Cosmetic Act (as added by subsection
(a)), the Secretary may, as appropriate, consult with any
relevant advisory committee within the Department of Health
and Human Services.
SEC. 202. LABORATORY ACCREDITATION FOR ANALYSES OF FOODS.
(a) In General.--Chapter IV (21 U.S.C. 341 et seq.), as
amended by section 201, is amended by adding at the end the
following:
``SEC. 422. LABORATORY ACCREDITATION FOR ANALYSES OF FOODS.
``(a) Recognition of Laboratory Accreditation.--
``(1) In general.--Not later than 2 years after the date of
enactment of the FDA Food Safety Modernization Act, the
Secretary shall--
``(A) establish a program for the testing of food by
accredited laboratories;
``(B) establish a 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 deemed appropriate by the Secretary about such
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 such
accreditation body or the accreditation of such 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 1 or more sampling and
analytical testing methodologies for food.
``(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 subparagraph (b) beyond the number so
qualified on the date of enactment of the FDA Food Safety
Modernization Act.
``(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 such laboratories meet the accreditation standards
applicable to domestic laboratories accredited under this
section.
``(6) Model laboratory standards.--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). In developing
the model standards, the Secretary shall consult existing
standards for guidance. The model standards shall include--
``(A) methods to ensure that--
``(i) appropriate sampling, analytical procedures
(including rapid analytical procedures), and commercially
available techniques are followed and reports of analyses are
certified as true and accurate;
``(ii) internal quality systems are established and
maintained;
[[Page H8873]]
``(iii) procedures exist to evaluate and respond promptly
to complaints regarding analyses and other activities for
which the laboratory is accredited; and
``(iv) individuals who conduct the sampling and analyses
are qualified by training and experience to do so; and
``(B) any other criteria determined appropriate by the
Secretary.
``(7) Review of recognition.--To ensure compliance with the
requirements of this section, the Secretary--
``(A) shall periodically, and in no case less 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 section, specifying, as appropriate, any
terms and conditions necessary for laboratories accredited by
such body to continue to perform testing as described in this
section.
``(b) Testing Procedures.--
``(1) In general.--Not later than 30 months after the date
of enactment of the FDA Food Safety Modernization Act, 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) whenever such testing is conducted--
``(A) by or on behalf of an owner or consignee--
``(i) in response to a specific testing requirement under
this Act or implementing regulations, when applied to address
an identified or suspected food safety problem; and
``(ii) as required by the Secretary, as the Secretary deems
appropriate, to address an identified or suspected food
safety problem; or
``(B) on behalf of an owner or consignee--
``(i) in support of admission of an article of food under
section 801(a); and
``(ii) under an Import Alert that requires successful
consecutive tests.
``(2) Results of testing.--The results of any such testing
shall be sent directly to the Food and Drug Administration,
except the Secretary may by regulation exempt test results
from such submission requirement if the Secretary determines
that such results do not contribute to the protection of
public health. Test results required to be submitted may be
submitted to the Food and Drug Administration through
electronic means.
``(3) Exception.--The Secretary may waive requirements
under this subsection if--
``(A) a new methodology or methodologies have been
developed and validated but a laboratory has not yet been
accredited to perform such methodology or methodologies; and
``(B) the use of such methodology or methodologies are
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 shall be construed to limit the ability of the
Secretary to review and act upon information from food
testing, including determining the sufficiency of such
information and testing.''.
(b) Food Emergency Response Network.--The Secretary, in
coordination with the Secretary of Agriculture, the Secretary
of Homeland Security, and State, local, and tribal
governments shall, not later than 180 days after the date of
enactment of this Act, and biennially thereafter, submit to
the relevant committees of Congress, and make publicly
available on the Internet Web site of the Department of
Health and Human Services, a report on the progress in
implementing a national food emergency response laboratory
network that--
(1) provides ongoing surveillance, rapid detection, and
surge capacity for large-scale food-related emergencies,
including intentional adulteration of the food supply;
(2) coordinates the food laboratory capacities of State,
local, and tribal food laboratories, including the adoption
of novel surveillance and identification technologies and the
sharing of data between Federal agencies and State
laboratories to develop national situational awareness;
(3) provides accessible, timely, accurate, and consistent
food laboratory services throughout the United States;
(4) develops and implements a methods repository for use by
Federal, State, and local officials;
(5) responds to food-related emergencies; and
(6) is integrated with relevant laboratory networks
administered by other Federal agencies.
SEC. 203. INTEGRATED CONSORTIUM OF LABORATORY NETWORKS.
(a) In General.--The Secretary of Homeland Security, in
coordination with the Secretary of Health and Human Services,
the Secretary of Agriculture, the Secretary of Commerce, and
the Administrator of the Environmental Protection Agency,
shall maintain an agreement through which relevant laboratory
network members, as determined by the Secretary of Homeland
Security, shall--
(1) agree on common laboratory methods in order to reduce
the time required to detect and respond to foodborne illness
outbreaks and facilitate the sharing of knowledge and
information relating to animal health, agriculture, and human
health;
(2) identify means by which laboratory network members
could work cooperatively--
(A) to optimize national laboratory preparedness; and
(B) to provide surge capacity during emergencies; and
(3) engage in ongoing dialogue and build relationships that
will support a more effective and integrated response during
emergencies.
(b) Reporting Requirement.--The Secretary of Homeland
Security shall, on a biennial basis, submit to the relevant
committees of Congress, and make publicly available on the
Internet Web site of the Department of Homeland Security, a
report on the progress of the integrated consortium of
laboratory networks, as established under subsection (a), in
carrying out this section.
SEC. 204. ENHANCING TRACKING AND TRACING OF FOOD AND
RECORDKEEPING.
(a) Pilot Projects.--
(1) In general.--Not later than 270 days after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary''),
taking into account recommendations from the Secretary of
Agriculture and representatives of State departments of
health and agriculture, shall establish pilot projects in
coordination with the food industry to explore and evaluate
methods to rapidly and effectively identify recipients of
food to prevent or mitigate a foodborne illness outbreak and
to address credible threats of serious adverse health
consequences or death to humans or animals as a result of
such food being adulterated under section 402 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 342) or misbranded
under section 403(w) of such Act (21 U.S.C. 343(w)).
(2) Content.--The Secretary shall conduct 1 or more pilot
projects under paragraph (1) in coordination with the
processed food sector and 1 or more such pilot projects in
coordination with processors or distributors of fruits and
vegetables that are raw agricultural commodities. The
Secretary shall ensure that the pilot projects under
paragraph (1) reflect the diversity of the food supply and
include at least 3 different types of foods that have been
the subject of significant outbreaks during the 5-year period
preceding the date of enactment of this Act, and are selected
in order to--
(A) develop and demonstrate methods for rapid and effective
tracking and tracing of foods in a manner that is practicable
for facilities of varying sizes, including small businesses;
(B) develop and demonstrate appropriate technologies,
including technologies existing on the date of enactment of
this Act, that enhance the tracking and tracing of food; and
(C) inform the promulgation of regulations under subsection
(d).
(3) Report.--Not later than 18 months after the date of
enactment of this Act, the Secretary shall report to Congress
on the findings of the pilot projects under this subsection
together with recommendations for improving the tracking and
tracing of food.
(b) Additional Data Gathering.--
(1) In general.--The Secretary, in coordination with the
Secretary of Agriculture and multiple representatives of
State departments of health and agriculture, shall assess--
(A) the costs and benefits associated with the adoption and
use of several product tracing technologies, including
technologies used in the pilot projects under subsection (a);
(B) the feasibility of such technologies for different
sectors of the food industry, including small businesses; and
(C) whether such technologies are compatible with the
requirements of this subsection.
(2) Requirements.--To the extent practicable, in carrying
out paragraph (1), the Secretary shall--
(A) evaluate domestic and international product tracing
practices in commercial use;
(B) consider international efforts, including an assessment
of whether product tracing requirements developed under this
section are compatible with global tracing systems, as
appropriate; and
(C) consult with a diverse and broad range of experts and
stakeholders, including representatives of the food industry,
agricultural producers, and nongovernmental organizations
that represent the interests of consumers.
(c) Product Tracing System.--The Secretary, in consultation
with the Secretary of Agriculture, shall, as appropriate,
establish within the Food and Drug Administration a product
tracing system to receive information that improves the
capacity of the Secretary to effectively and rapidly track
and trace food that is in the United States or offered for
import into the United States. Prior to the establishment of
such product tracing system, the Secretary shall examine the
results of applicable pilot projects and shall ensure that
the activities of such system are adequately supported by the
results of such pilot projects.
(d) Additional Recordkeeping Requirements for High Risk
Foods.--
(1) In general.--In order to rapidly and effectively
identify recipients of a food to prevent or mitigate a
foodborne illness outbreak and to address credible threats of
serious adverse health consequences or death to humans or
animals as a result of such food being adulterated under
section 402 of the Federal Food, Drug, and Cosmetic Act or
misbranded under section 403(w) of such Act, not later than 2
years after the date of enactment of this Act, the Secretary
shall publish a notice of proposed rulemaking to establish
recordkeeping requirements, in addition to the requirements
under section 414 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 350c) and subpart J of part 1 of title 21, Code of
Federal Regulations (or any successor
[[Page H8874]]
regulations), for facilities that manufacture, process, pack,
or hold foods that the Secretary designates under paragraph
(2) as high-risk foods. The Secretary shall set an
appropriate effective date of such additional requirements
for foods designated as high risk that takes into account the
length of time necessary to comply with such requirements.
Such requirements shall--
(A) relate only to information that is reasonably available
and appropriate;
(B) be science-based;
(C) not prescribe specific technologies for the maintenance
of records;
(D) ensure that the public health benefits of imposing
additional recordkeeping requirements outweigh the cost of
compliance with such requirements;
(E) be scale-appropriate and practicable for facilities of
varying sizes and capabilities with respect to costs and
recordkeeping burdens, and not require the creation and
maintenance of duplicate records where the information is
contained in other company records kept in the normal course
of business;
(F) minimize the number of different recordkeeping
requirements for facilities that handle more than 1 type of
food;
(G) to the extent practicable, not require a facility to
change business systems to comply with such requirements;
(H) allow any person subject to this subsection to maintain
records required under this subsection at a central or
reasonably accessible location provided that such records can
be made available to the Secretary not later than 24 hours
after the Secretary requests such records; and
(I) include a process by which the Secretary may issue a
waiver of the requirements under this subsection if the
Secretary determines that such requirements would result in
an economic hardship for an individual facility or a type of
facility;
(J) be commensurate with the known safety risks of the
designated food;
(K) take into account international trade obligations;
(L) not require--
(i) a full pedigree, or a record of the complete previous
distribution history of the food from the point of origin of
such food;
(ii) records of recipients of a food beyond the immediate
subsequent recipient of such food; or
(iii) product tracking to the case level by persons subject
to such requirements; and
(M) include a process by which the Secretary may remove a
high-risk food designation developed under paragraph (2) for
a food or type of food.
(2) Designation of high-risk foods.--
(A) In general.--Not later than 1 year after the date of
enactment of this Act, and thereafter as the Secretary
determines necessary, the Secretary shall designate high-risk
foods for which the additional recordkeeping requirements
described in paragraph (1) are appropriate and necessary to
protect the public health. Each such designation shall be
based on--
(i) the known safety risks of a particular food, including
the history and severity of foodborne illness outbreaks
attributed to such food, taking into consideration foodborne
illness data collected by the Centers for Disease Control and
Prevention;
(ii) the likelihood that a particular food has a high
potential risk for microbiological or chemical contamination
or would support the growth of pathogenic microorganisms due
to the nature of the food or the processes used to produce
such food;
(iii) the point in the manufacturing process of the food
where contamination is most likely to occur;
(iv) the likelihood of contamination and steps taken during
the manufacturing process to reduce the possibility of
contamination;
(v) the likelihood that consuming a particular food will
result in a foodborne illness due to contamination of the
food; and
(vi) the likely or known severity, including health and
economic impacts, of a foodborne illness attributed to a
particular food.
(B) List of high-risk foods.--At the time the Secretary
promulgates the final rules under paragraph (1), the
Secretary shall publish the list of the foods designated
under subparagraph (A) as high-risk foods on the Internet
website of the Food and Drug Administration. The Secretary
may update the list to designate new high-risk foods and to
remove foods that are no longer deemed to be high-risk foods,
provided that each such update to the list is consistent with
the requirements of this subsection and notice of such update
is published in the Federal Register.
(3) Protection of sensitive information.--In promulgating
regulations under this subsection, the Secretary shall take
appropriate measures to ensure that there are effective
procedures to prevent the unauthorized disclosure of any
trade secret or confidential information that is obtained by
the Secretary pursuant to this section, including periodic
risk assessment and planning to prevent unauthorized release
and controls to--
(A) prevent unauthorized reproduction of trade secret or
confidential information;
(B) prevent unauthorized access to trade secret or
confidential information; and
(C) maintain records with respect to access by any person
to trade secret or confidential information maintained by the
agency.
(4) Public input.--During the comment period in the notice
of proposed rulemaking under paragraph (1), the Secretary
shall conduct not less than 3 public meetings in diverse
geographical areas of the United States to provide persons in
different regions an opportunity to comment.
(5) Retention of records.--Except as otherwise provided in
this subsection, the Secretary may require that a facility
retain records under this subsection for not more than 2
years, taking into consideration the risk of spoilage, loss
of value, or loss of palatability of the applicable food when
determining the appropriate timeframes.
(6) Limitations.--
(A) Farm to school programs.--In establishing requirements
under this subsection, the Secretary shall, in consultation
with the Secretary of Agriculture, consider the impact of
requirements on farm to school or farm to institution
programs of the Department of Agriculture and other farm to
school and farm to institution programs outside such agency,
and shall modify the requirements under this subsection, as
appropriate, with respect to such programs so that the
requirements do not place undue burdens on farm to school or
farm to institution programs.
(B) Identity-preserved labels with respect to farm sales of
food that is produced and packaged on a farm.--The
requirements under this subsection shall not apply to a food
that is produced and packaged on a farm if--
(i) the packaging of the food maintains the integrity of
the product and prevents subsequent contamination or
alteration of the product; and
(ii) the labeling of the food includes the name, complete
address (street address, town, State, country, and zip or
other postal code), and business phone number of the farm,
unless the Secretary waives the requirement to include a
business phone number of the farm, as appropriate, in order
to accommodate a religious belief of the individual in charge
of such farm.
(C) Fishing vessels.--The requirements under this
subsection with respect to a food that is produced through
the use of a fishing vessel (as defined in section 3(18) of
the Magnuson-Stevens Fishery Conservation and Management Act
(16 U.S.C. 1802(18))) shall be limited to the requirements
under subparagraph (F) until such time as the food is sold by
the owner, operator, or agent in charge of such fishing
vessel.
(D) Commingled raw agricultural commodities.--
(i) Limitation on extent of tracing.--Recordkeeping
requirements under this subsection with regard to any
commingled raw agricultural commodity shall be limited to the
requirements under subparagraph (F).
(ii) Definitions.--For the purposes of this subparagraph--
(I) the term ``commingled raw agricultural commodity''
means any commodity that is combined or mixed after
harvesting, but before processing;
(II) the term ``commingled raw agricultural commodity''
shall not include types of fruits and vegetables that are raw
agricultural commodities for which the Secretary has
determined that standards promulgated under section 419 of
the Federal Food, Drug, and Cosmetic Act (as added by section
105) would minimize the risk of serious adverse health
consequences or death; and
(III) the term ``processing'' means operations that alter
the general state of the commodity, such as canning, cooking,
freezing, dehydration, milling, grinding, pasteurization, or
homogenization.
(E) Exemption of other foods.--The Secretary may, by notice
in the Federal Register, modify the requirements under this
subsection with respect to, or exempt a food or a type of
facility from, the requirements of this subsection (other
than the requirements under subparagraph (F), if applicable)
if the Secretary determines that product tracing requirements
for such food (such as bulk or commingled ingredients that
are intended to be processed to destroy pathogens) or type of
facility is not necessary to protect the public health.
(F) Recordkeeping regarding previous sources and subsequent
recipients.--In the case of a person or food to which a
limitation or exemption under subparagraph (C), (D), or (E)
applies, if such person, or a person who manufactures,
processes, packs, or holds such food, is required to register
with the Secretary under section 415 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 350d) with respect to the
manufacturing, processing, packing, or holding of the
applicable food, the Secretary shall require such person to
maintain records that identify the immediate previous source
of such food and the immediate subsequent recipient of such
food.
(G) Grocery stores.--With respect to a sale of a food
described in subparagraph (H) to a grocery store, the
Secretary shall not require such grocery store to maintain
records under this subsection other than records documenting
the farm that was the source of such food. The Secretary
shall not require that such records be kept for more than 180
days.
(H) Farm sales to consumers.--The Secretary shall not
require a farm to maintain any distribution records under
this subsection with respect to a sale of a food described in
subparagraph (I) (including a sale of a food that is produced
and packaged on such farm), if such sale is made by the farm
directly to a consumer.
(I) Sale of a food.--A sale of a food described in this
subparagraph is a sale of a food in which--
(i) the food is produced on a farm; and
(ii) the sale is made by the owner, operator, or agent in
charge of such farm directly to a consumer or grocery store.
(7) No impact on non-high-risk foods.--The recordkeeping
requirements established under paragraph (1) shall have no
effect on foods that are not designated by the Secretary
under paragraph (2) as high-risk foods. Foods described in
the preceding sentence shall be subject solely to the
recordkeeping requirements under section 414 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 350c) and subpart J
of part 1 of title 21, Code of Federal Regulations (or any
successor regulations).
(e) Evaluation and Recommendations.--
(1) Report.--Not later than 1 year after the effective date
of the final rule promulgated under subsection (d)(1), the
Comptroller General
[[Page H8875]]
of the United States shall submit to Congress a report,
taking into consideration the costs of compliance and other
regulatory burdens on small businesses and Federal, State,
and local food safety practices and requirements, that
evaluates the public health benefits and risks, if any, of
limiting--
(A) the product tracing requirements under subsection (d)
to foods identified under paragraph (2) of such subsection,
including whether such requirements provide adequate
assurance of traceability in the event of intentional
adulteration, including by acts of terrorism; and
(B) the participation of restaurants in the recordkeeping
requirements.
(2) Determination and recommendations.--In conducting the
evaluation and report under paragraph (1), if the Comptroller
General of the United States determines that the limitations
described in such paragraph do not adequately protect the
public health, the Comptroller General shall submit to
Congress recommendations, if appropriate, regarding
recordkeeping requirements for restaurants and additional
foods, in order to protect the public health.
(f) Farms.--
(1) Request for information.--Notwithstanding subsection
(d), during an active investigation of a foodborne illness
outbreak, or if the Secretary determines it is necessary to
protect the public health and prevent or mitigate a foodborne
illness outbreak, the Secretary, in consultation and
coordination with State and local agencies responsible for
food safety, as appropriate, may request that the owner,
operator, or agent of a farm identify potential immediate
recipients, other than consumers, of an article of the food
that is the subject of such investigation if the Secretary
reasonably believes such article of food--
(A) is adulterated under section 402 of the Federal Food,
Drug, and Cosmetic Act;
(B) presents a threat of serious adverse health
consequences or death to humans or animals; and
(C) was adulterated as described in subparagraph (A) on a
particular farm (as defined in section 1.227 of chapter 21,
Code of Federal Regulations (or any successor regulation)).
(2) Manner of request.--In making a request under paragraph
(1), the Secretary, in consultation and coordination with
State and local agencies responsible for food safety, as
appropriate, shall issue a written notice to the owner,
operator, or agent of the farm to which the article of food
has been traced. The individual providing such notice shall
present to such owner, operator, or agent appropriate
credentials and shall deliver such notice at reasonable times
and within reasonable limits and in a reasonable manner.
(3) Delivery of information requested.--The owner,
operator, or agent of a farm shall deliver the information
requested under paragraph (1) in a prompt and reasonable
manner. Such information may consist of records kept in the
normal course of business, and may be in electronic or non-
electronic format.
(4) Limitation.--A request made under paragraph (1) shall
not include a request for information relating to the
finances, pricing of commodities produced, personnel,
research, sales (other than information relating to
shipping), or other disclosures that may reveal trade secrets
or confidential information from the farm to which the
article of food has been traced, other than information
necessary to identify potential immediate recipients of such
food. Section 301(j) of the Federal Food, Drug, and Cosmetic
Act and the Freedom of Information Act shall apply with
respect to any confidential commercial information that is
disclosed to the Food and Drug Administration in the course
of responding to a request under paragraph (1).
(5) Records.--Except with respect to identifying potential
immediate recipients in response to a request under this
subsection, nothing in this subsection shall require the
establishment or maintenance by farms of new records.
(g) No Limitation on Commingling of Food.--Nothing in this
section shall be construed to authorize the Secretary to
impose any limitation on the commingling of food.
(h) Small Entity Compliance Guide.--Not later than 180 days
after promulgation of a final rule under subsection (d), the
Secretary shall issue a small entity compliance guide setting
forth in plain language the requirements of the regulations
under such subsection in order to assist small entities,
including farms and small businesses, in complying with the
recordkeeping requirements under such subsection.
(i) Flexibility for Small Businesses.--Notwithstanding any
other provision of law, the regulations promulgated under
subsection (d) shall apply--
(1) to small businesses (as defined by the Secretary in
section 103, not later than 90 days after the date of
enactment of this Act) beginning on the date that is 1 year
after the effective date of the final regulations promulgated
under subsection (d); and
(2) to very small businesses (as defined by the Secretary
in section 103, not later than 90 days after the date of
enactment of this Act) beginning on the date that is 2 years
after the effective date of the final regulations promulgated
under subsection (d).
(j) Enforcement.--
(1) Prohibited acts.--Section 301(e) (21 U.S.C. 331(e)) is
amended by inserting ``; or the violation of any
recordkeeping requirement under section 204 of the FDA Food
Safety Modernization Act (except when such violation is
committed by a farm)'' before the period at the end.
(2) Imports.--Section 801(a) (21 U.S.C. 381(a)) is amended
by inserting ``or (4) the recordkeeping requirements under
section 204 of the FDA Food Safety Modernization Act (other
than the requirements under subsection (f) of such section)
have not been complied with regarding such article,'' in the
third sentence before ``then such article shall be refused
admission''.
SEC. 205. SURVEILLANCE.
(a) Definition of Foodborne Illness Outbreak.--In this Act,
the term ``foodborne illness outbreak'' means the occurrence
of 2 or more cases of a similar illness resulting from the
ingestion of a certain food.
(b) Foodborne Illness Surveillance Systems.--
(1) In general.--The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, shall
enhance foodborne illness surveillance systems to improve the
collection, analysis, reporting, and usefulness of data on
foodborne illnesses by--
(A) coordinating Federal, State and local foodborne illness
surveillance systems, including complaint systems, and
increasing participation in national networks of public
health and food regulatory agencies and laboratories;
(B) facilitating sharing of surveillance information on a
more timely basis among governmental agencies, including the
Food and Drug Administration, the Department of Agriculture,
the Department of Homeland Security, and State and local
agencies, and with the public;
(C) developing improved epidemiological tools for obtaining
quality exposure data and microbiological methods for
classifying cases;
(D) augmenting such systems to improve attribution of a
foodborne illness outbreak to a specific food;
(E) expanding capacity of such systems, including working
toward automatic electronic searches, for implementation of
identification practices, including fingerprinting
strategies, for foodborne infectious agents, in order to
identify new or rarely documented causes of foodborne illness
and submit standardized information to a centralized
database;
(F) allowing timely public access to aggregated, de-
identified surveillance data;
(G) at least annually, publishing current reports on
findings from such systems;
(H) establishing a flexible mechanism for rapidly
initiating scientific research by academic institutions;
(I) integrating foodborne illness surveillance systems and
data with other biosurveillance and public health situational
awareness capabilities at the Federal, State, and local
levels, including by sharing foodborne illness surveillance
data with the National Biosurveillance Integration Center;
and
(J) other activities as determined appropriate by the
Secretary.
(2) Working group.--The Secretary shall support and
maintain a diverse working group of experts and stakeholders
from Federal, State, and local food safety and health
agencies, the food and food testing industries, consumer
organizations, and academia. Such working group shall provide
the Secretary, through at least annual meetings of the
working group and an annual public report, advice and
recommendations on an ongoing and regular basis regarding the
improvement of foodborne illness surveillance and
implementation of this section, including advice and
recommendations on--
(A) the priority needs of regulatory agencies, the food
industry, and consumers for information and analysis on
foodborne illness and its causes;
(B) opportunities to improve the effectiveness of
initiatives at the Federal, State, and local levels,
including coordination and integration of activities among
Federal agencies, and between the Federal, State, and local
levels of government;
(C) improvement in the timeliness and depth of access by
regulatory and health agencies, the food industry, academic
researchers, and consumers to foodborne illness aggregated,
de-identified surveillance data collected by government
agencies at all levels, including data compiled by the
Centers for Disease Control and Prevention;
(D) key barriers at Federal, State, and local levels to
improving foodborne illness surveillance and the utility of
such surveillance for preventing foodborne illness;
(E) the capabilities needed for establishing automatic
electronic searches of surveillance data; and
(F) specific actions to reduce barriers to improvement,
implement the working group's recommendations, and achieve
the purposes of this section, with measurable objectives and
timelines, and identification of resource and staffing needs.
(3) Authorization of appropriations.--To carry out the
activities described in paragraph (1), there is authorized to
be appropriated $24,000,000 for each fiscal years 2011
through 2015.
(c) Improving Food Safety and Defense Capacity at the State
and Local Level.--
(1) In general.--The Secretary shall develop and implement
strategies to leverage and enhance the food safety and
defense capacities of State and local agencies in order to
achieve the following goals:
(A) Improve foodborne illness outbreak response and
containment.
(B) Accelerate foodborne illness surveillance and outbreak
investigation, including rapid shipment of clinical isolates
from clinical laboratories to appropriate State laboratories,
and conducting more standardized illness outbreak interviews.
(C) Strengthen the capacity of State and local agencies to
carry out inspections and enforce safety standards.
(D) Improve the effectiveness of Federal, State, and local
partnerships to coordinate food safety and defense resources
and reduce the incidence of foodborne illness.
(E) Share information on a timely basis among public health
and food regulatory agencies, with the food industry, with
health care providers, and with the public.
[[Page H8876]]
(F) Strengthen the capacity of State and local agencies to
achieve the goals described in section 108.
(2) Review.--In developing of the strategies required by
paragraph (1), the Secretary shall, not later than 1 year
after the date of enactment of the FDA Food Safety
Modernization Act, complete a review of State and local
capacities, and needs for enhancement, which may include a
survey with respect to--
(A) staffing levels and expertise available to perform food
safety and defense functions;
(B) laboratory capacity to support surveillance, outbreak
response, inspection, and enforcement activities;
(C) information systems to support data management and
sharing of food safety and defense information among State
and local agencies and with counterparts at the Federal
level; and
(D) other State and local activities and needs as
determined appropriate by the Secretary.
(d) Food Safety Capacity Building Grants.--Section 317R(b)
of the Public Health Service Act (42 U.S.C. 247b-20(b)) is
amended--
(1) by striking ``2002'' and inserting ``2010''; and
(2) by striking ``2003 through 2006'' and inserting ``2011
through 2015''.
SEC. 206. MANDATORY RECALL AUTHORITY.
(a) In General.--Chapter IV (21 U.S.C. 341 et seq.), as
amended by section 202, is amended by adding at the end the
following:
``SEC. 423. MANDATORY RECALL AUTHORITY.
``(a) Voluntary Procedures.--If the Secretary determines,
based on information gathered through the reportable food
registry under section 417 or through any other means, that
there is a reasonable probability that an article of food
(other than infant formula) is adulterated under section 402
or misbranded under section 403(w) and the use of or exposure
to such article will cause serious adverse health
consequences or death to humans or animals, the Secretary
shall provide the responsible party (as defined in section
417) with an opportunity to cease distribution and recall
such article.
``(b) Prehearing Order To Cease Distribution and Give
Notice.--
``(1) In general.--If the responsible party refuses to or
does not voluntarily cease distribution or recall such
article within the time and in the manner prescribed by the
Secretary (if so prescribed), the Secretary may, by order
require, as the Secretary deems necessary, such person to--
``(A) immediately cease distribution of such article; and
``(B) as applicable, immediately notify all persons--
``(i) manufacturing, processing, packing, transporting,
distributing, receiving, holding, or importing and selling
such article; and
``(ii) to which such article has been distributed,
transported, or sold, to 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 this Act, including the
requirements in this section and section 414; 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
Secretary requires a responsible party to cease distribution
under paragraph (1)(A) of an article of food identified in
subsection (a), the Secretary may limit the size of the
geographic area and the markets affected by such cessation if
such limitation would not compromise the public health.
``(c) Hearing on Order.--The Secretary shall provide the
responsible party 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 Secretary
determines that removal of the article from commerce is
necessary, the Secretary 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 Secretary 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
Secretary determines that adequate grounds do not exist to
continue the actions required by the order, or that such
actions should be modified, the Secretary shall vacate the
order or modify the order.
``(e) Rule Regarding Alcoholic Beverages.--The Secretary
shall not initiate a mandatory recall or take any other
action under this section with respect to any alcohol
beverage until the Secretary 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 authority.
``(f) Cooperation and Consultation.--The Secretary 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 Secretary 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) consult the policies of the Department of Agriculture
regarding providing to the public a list of retail consignees
receiving products involved in a Class I recall and shall
consider providing such a list to the public, as determined
appropriate by the Secretary; and
``(3) if available, publish on the Internet Web site of the
Food and Drug Administration an image of the article that is
the subject of the press release described in (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
Commissioner.
``(i) Effect.--Nothing in this section shall affect the
authority of the Secretary to request or participate in a
voluntary recall, or to issue an order to cease distribution
or to recall under any other provision of this Act or under
the Public Health Service Act.
``(j) Coordinated Communication.--
``(1) In general.--To assist in carrying out the
requirements of this subsection, the Secretary shall
establish an incident command operation or a similar
operation within the Department of Health and Human Services
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 food borne 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 Department of Health and Human Services
to--
``(A) ensure timely and coordinated communication within
the Department, including enhanced communication and
coordination between different agencies and organizations
within the Department;
``(B) ensure timely and coordinated communication from the
Department, including public statements, throughout the
duration of the investigation and related foodborne illness
outbreak;
``(C) identify a single point of contact within the
Department for public inquiries regarding any actions by the
Secretary 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 identified 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 Secretary
determines appropriate.
``(3) Multiple recalls.--The Secretary may establish
multiple or concurrent incident command operations or similar
operations in the event of multiple recalls or foodborne
illness outbreaks necessitating such action by the Department
of Health and Human Services.''.
(b) Search Engine.--Not later than 90 days after the date
of enactment of this Act, the Secretary shall modify the
Internet Web site of the Food and Drug Administration to
include a search engine that--
(1) is consumer-friendly, as determined by the Secretary;
and
(2) provides a means by which an individual may locate
relevant information regarding each article of food subject
to a recall under section 423 of the Federal Food, Drug, and
Cosmetic Act and the status of such recall (such as whether a
recall is ongoing or has been completed).
(c) Civil Penalty.--Section 303(f)(2)(A) (21 U.S.C.
333(f)(2)(A)) is amended by inserting ``or any person who
does not comply with a recall order under section 423'' after
``section 402(a)(2)(B)''.
(d) Prohibited Acts.--Section 301 (21 U.S.C. 331 et seq.),
as amended by section 106, is amended by adding at the end
the following:
``(xx) The refusal or failure to follow an order under
section 423.''.
(e) GAO Review.--
(1) In general.--Not later than 90 days after the date of
enactment of this Act, the Comptroller General of the United
States shall submit to Congress a report that--
(A) identifies State and local agencies with the authority
to require the mandatory recall of food, and evaluates use of
such authority with regard to frequency, effectiveness, and
appropriateness, including consideration of any new or
existing mechanisms available to compensate persons for
general and specific recall-related costs when a recall is
subsequently determined by the relevant authority to have
been an error;
[[Page H8877]]
(B) identifies Federal agencies, other than the Department
of Health and Human Services, with mandatory recall authority
and examines use of that authority with regard to frequency,
effectiveness, and appropriateness, including any new or
existing mechanisms available to compensate persons for
general and specific recall-related costs when a recall is
subsequently determined by the relevant agency to have been
an error;
(C) considers models for farmer restitution implemented in
other nations in cases of erroneous recalls; and
(D) makes recommendations to the Secretary regarding use of
the authority under section 423 of the Federal Food, Drug,
and Cosmetic Act (as added by this section) to protect the
public health while seeking to minimize unnecessary economic
costs.
(2) Effect of review.--If the Comptroller General of the
United States finds, after the review conducted under
paragraph (1), that the mechanisms described in such
paragraph do not exist or are inadequate, then, not later
than 90 days after the conclusion of such review, the
Secretary of Agriculture shall conduct a study of the
feasibility of implementing a farmer indemnification program
to provide restitution to agricultural producers for losses
sustained as a result of a mandatory recall of an
agricultural commodity by a Federal or State regulatory
agency that is subsequently determined to be in error. The
Secretary of Agriculture shall submit to the Committee on
Agriculture of the House of Representatives and the Committee
on Agriculture, Nutrition, and Forestry of the Senate a
report that describes the results of the study, including any
recommendations.
(f) Annual Report to Congress.--
(1) In general.--Not later than 2 years after the date of
enactment of this Act and annually thereafter, the Secretary
of Health and Human Services (referred to in this subsection
as the ``Secretary'') shall submit a report to the Committee
on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of
Representatives on the use of recall authority under section
423 of the Federal Food, Drug, and Cosmetic Act (as added by
subsection (a)) and any public health advisories issued by
the Secretary that advise against the consumption of an
article of food on the ground that the article of food is
adulterated and poses an imminent danger to health.
(2) Content.--The report under paragraph (1) shall include,
with respect to the report year--
(A) the identity of each article of food that was the
subject of a public health advisory described in paragraph
(1), an opportunity to cease distribution and recall under
subsection (a) of section 423 of the Federal Food, Drug, and
Cosmetic Act, or a mandatory recall order under subsection
(b) of such section;
(B) the number of responsible parties, as defined in
section 417 of the Federal Food, Drug, and Cosmetic Act,
formally given the opportunity to cease distribution of an
article of food and recall such article, as described in
section 423(a) of such Act;
(C) the number of responsible parties described in
subparagraph (B) who did not cease distribution of or recall
an article of food after given the opportunity to cease
distribution or recall under section 423(a) of the Federal
Food, Drug, and Cosmetic Act;
(D) the number of recall orders issued under section 423(b)
of the Federal Food, Drug, and Cosmetic Act; and
(E) a description of any instances in which there was no
testing that confirmed adulteration of an article of food
that was the subject of a recall under section 423(b) of the
Federal Food, Drug, and Cosmetic Act or a public health
advisory described in paragraph (1).
SEC. 207. ADMINISTRATIVE DETENTION OF FOOD.
(a) In General.--Section 304(h)(1)(A) (21 U.S.C.
334(h)(1)(A)) is amended by--
(1) striking ``credible evidence or information
indicating'' and inserting ``reason to believe''; and
(2) striking ``presents a threat of serious adverse health
consequences or death to humans or animals'' and inserting
``is adulterated or misbranded''.
(b) Regulations.--Not later than 120 days after the date of
enactment of this Act, the Secretary shall issue an interim
final rule amending subpart K of part 1 of title 21, Code of
Federal Regulations, to implement the amendment made by this
section.
(c) Effective Date.--The amendment made by this section
shall take effect 180 days after the date of enactment of
this Act.
SEC. 208. DECONTAMINATION AND DISPOSAL STANDARDS AND PLANS.
(a) In General.--The Administrator of the Environmental
Protection Agency (referred to in this section as the
``Administrator''), in coordination with the Secretary of
Health and Human Services, Secretary of Homeland Security,
and Secretary of Agriculture, shall provide support for, and
technical assistance to, State, local, and tribal governments
in preparing for, assessing, decontaminating, and recovering
from an agriculture or food emergency.
(b) Development of Standards.--In carrying out subsection
(a), the Administrator, in coordination with the Secretary of
Health and Human Services, Secretary of Homeland Security,
Secretary of Agriculture, and State, local, and tribal
governments, shall develop and disseminate specific standards
and protocols to undertake clean-up, clearance, and recovery
activities following the decontamination and disposal of
specific threat agents and foreign animal diseases.
(c) Development of Model Plans.--In carrying out subsection
(a), the Administrator, the Secretary of Health and Human
Services, and the Secretary of Agriculture shall jointly
develop and disseminate model plans for--
(1) the decontamination of individuals, equipment, and
facilities following an intentional contamination of
agriculture or food; and
(2) the disposal of large quantities of animals, plants, or
food products that have been infected or contaminated by
specific threat agents and foreign animal diseases.
(d) Exercises.--In carrying out subsection (a), the
Administrator, in coordination with the entities described
under subsection (b), shall conduct exercises at least
annually to evaluate and identify weaknesses in the
decontamination and disposal model plans described in
subsection (c). Such exercises shall be carried out, to the
maximum extent practicable, as part of the national exercise
program under section 648(b)(1) of the Post-Katrina Emergency
Management Reform Act of 2006 (6 U.S.C. 748(b)(1)).
(e) Modifications.--Based on the exercises described in
subsection (d), the Administrator, in coordination with the
entities described in subsection (b), shall review and modify
as necessary the plans described in subsection (c) not less
frequently than biennially.
(f) Prioritization.--The Administrator, in coordination
with the entities described in subsection (b), shall develop
standards and plans under subsections (b) and (c) in an
identified order of priority that takes into account--
(1) highest-risk biological, chemical, and radiological
threat agents;
(2) agents that could cause the greatest economic
devastation to the agriculture and food system; and
(3) agents that are most difficult to clean or remediate.
SEC. 209. IMPROVING THE TRAINING OF STATE, LOCAL,
TERRITORIAL, AND TRIBAL FOOD SAFETY OFFICIALS.
(a) Improving Training.--Chapter X (21 U.S.C. 391 et seq.)
is amended by adding at the end the following:
``SEC. 1011. IMPROVING THE TRAINING OF STATE, LOCAL,
TERRITORIAL, AND TRIBAL FOOD SAFETY OFFICIALS.
``(a) Training.--The Secretary shall set standards and
administer training and education programs for the employees
of State, local, territorial, and tribal food safety
officials relating to the regulatory responsibilities and
policies established by this Act, including programs for--
``(1) scientific training;
``(2) training to improve the skill of officers and
employees authorized to conduct inspections under sections
702 and 704;
``(3) training to achieve advanced product or process
specialization in such inspections;
``(4) training that addresses best practices;
``(5) training in administrative process and procedure and
integrity issues;
``(6) training in appropriate sampling and laboratory
analysis methodology; and
``(7) training in building enforcement actions following
inspections, examinations, testing, and investigations.
``(b) Partnerships With State and Local Officials.--
``(1) In general.--The Secretary, pursuant to a contract or
memorandum of understanding between the Secretary and the
head of a State, local, territorial, or tribal department or
agency, is authorized and encouraged to conduct examinations,
testing, and investigations for the purposes of determining
compliance with the food safety provisions of this Act
through the officers and employees of such State, local,
territorial, or tribal department or agency.
``(2) Content.--A contract or memorandum described under
paragraph (1) shall include provisions to ensure adequate
training of such officers and employees to conduct such
examinations, testing, and investigations. The contract or
memorandum shall contain provisions regarding reimbursement.
Such provisions may, at the sole discretion of the head of
the other department or agency, require reimbursement, in
whole or in part, from the Secretary for the examinations,
testing, or investigations performed pursuant to this section
by the officers or employees of the State, territorial, or
tribal department or agency.
``(3) Effect.--Nothing in this subsection shall be
construed to limit the authority of the Secretary under
section 702.
``(c) Extension Service.--The Secretary shall ensure
coordination with the extension activities of the National
Institute of Food and Agriculture of the Department of
Agriculture in advising producers and small processors
transitioning into new practices required as a result of the
enactment of the FDA Food Safety Modernization Act and
assisting regulated industry with compliance with such Act.
``(d) National Food Safety Training, Education, Extension,
Outreach and Technical Assistance Program.--
``(1) In general.--In order to improve food safety and
reduce the incidence of foodborne illness, the Secretary
shall, not later than 180 days after the date of enactment of
the FDA Food Safety Modernization Act, enter into one or more
memoranda of understanding, or enter into other cooperative
agreements, with the Secretary of Agriculture to establish a
competitive grant program within the National Institute for
Food and Agriculture to provide food safety training,
education, extension, outreach, and technical assistance to--
``(A) owners and operators of farms;
``(B) small food processors; and
``(C) small fruit and vegetable merchant wholesalers.
``(2) Implementation.--The competitive grant program
established under paragraph (1) shall be carried out in
accordance with section 405 of the Agricultural Research,
Extension, and Education Reform Act of 1998.
``(e) Authorization of Appropriations.--There are
authorized to be appropriated such
[[Page H8878]]
sums as may be necessary to carry out this section for fiscal
years 2011 through 2015.''.
(b) National Food Safety Training, Education, Extension,
Outreach, and Technical Assistance Program.--Title IV of the
Agricultural Research, Extension, and Education Reform Act of
1998 is amended by inserting after section 404 (7 U.S.C.
7624) the following:
``SEC. 405. NATIONAL FOOD SAFETY TRAINING, EDUCATION,
EXTENSION, OUTREACH, AND TECHNICAL ASSISTANCE
PROGRAM.
``(a) In General.--The Secretary shall award grants under
this section to carry out the competitive grant program
established under section 1011(d) of the Federal Food, Drug,
and Cosmetic Act, pursuant to any memoranda of understanding
entered into under such section.
``(b) Integrated Approach.--The grant program described
under subsection (a) shall be carried out under this section
in a manner that facilitates the integration of food safety
standards and guidance with the variety of agricultural
production systems, encompassing conventional, sustainable,
organic, and conservation and environmental practices.
``(c) Priority.--In awarding grants under this section, the
Secretary shall give priority to projects that target small
and medium-sized farms, beginning farmers, socially
disadvantaged farmers, small processors, or small fresh fruit
and vegetable merchant wholesalers.
``(d) Program Coordination.--
``(1) In general.--The Secretary shall coordinate
implementation of the grant program under this section with
the National Integrated Food Safety Initiative.
``(2) Interaction.--The Secretary shall--
``(A) in carrying out the grant program under this section,
take into consideration applied research, education, and
extension results obtained from the National Integrated Food
Safety Initiative; and
``(B) in determining the applied research agenda for the
National Integrated Food Safety Initiative, take into
consideration the needs articulated by participants in
projects funded by the program under this section.
``(e) Grants.--
``(1) In general.--In carrying out this section, the
Secretary shall make competitive grants to support training,
education, extension, outreach, and technical assistance
projects that will help improve public health by increasing
the understanding and adoption of established food safety
standards, guidance, and protocols.
``(2) Encouraged features.--The Secretary shall encourage
projects carried out using grant funds under this section to
include co-management of food safety, conservation systems,
and ecological health.
``(3) Maximum term and size of grant.--
``(A) In general.--A grant under this section shall have a
term that is not more than 3 years.
``(B) Limitation on grant funding.--The Secretary may not
provide grant funding to an entity under this section after
such entity has received 3 years of grant funding under this
section.
``(f) Grant Eligibility.--
``(1) In general.--To be eligible for a grant under this
section, an entity shall be--
``(A) a State cooperative extension service;
``(B) a Federal, State, local, or tribal agency, a
nonprofit community-based or non-governmental organization,
or an organization representing owners and operators of
farms, small food processors, or small fruit and vegetable
merchant wholesalers that has a commitment to public health
and expertise in administering programs that contribute to
food safety;
``(C) an institution of higher education (as defined in
section 101(a) of the Higher Education Act of 1965 (20 U.S.C.
1001(a))) or a foundation maintained by an institution of
higher education;
``(D) a collaboration of 2 of more eligible entities
described in this subsection; or
``(E) such other appropriate entity, as determined by the
Secretary.
``(2) Multistate partnerships.--Grants under this section
may be made for projects involving more than 1 State.
``(g) Regional Balance.--In making grants under this
section, the Secretary shall, to the maximum extent
practicable, ensure--
``(1) geographic diversity; and
``(2) diversity of types of agricultural production.
``(h) Technical Assistance.--The Secretary may use funds
made available under this section to provide technical
assistance to grant recipients to further the purposes of
this section.
``(i) Best Practices and Model Programs.--Based on
evaluations of, and responses arising from, projects funded
under this section, the Secretary may issue a set of
recommended best practices and models for food safety
training programs for agricultural producers, small food
processors, and small fresh fruit and vegetable merchant
wholesalers.
``(j) Authorization of Appropriations.--For the purposes of
making grants under this section, there are authorized to be
appropriated such sums as may be necessary for fiscal years
2011 through 2015.''.
SEC. 210. ENHANCING FOOD SAFETY.
(a) Grants To Enhance Food Safety.--Section 1009 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 399) is
amended to read as follows:
``SEC. 1009. GRANTS TO ENHANCE FOOD SAFETY.
``(a) In General.--The Secretary is authorized to make
grants to eligible entities to--
``(1) undertake examinations, inspections, and
investigations, and related food safety activities under
section 702;
``(2) train to the standards of the Secretary for the
examination, inspection, and investigation of food
manufacturing, processing, packing, holding, distribution,
and importation, including as such examination, inspection,
and investigation relate to retail food establishments;
``(3) build the food safety capacity of the laboratories of
such eligible entity, including the detection of zoonotic
diseases;
``(4) build the infrastructure and capacity of the food
safety programs of such eligible entity to meet the standards
as outlined in the grant application; and
``(5) take appropriate action to protect the public health
in response to--
``(A) a notification under section 1008, including planning
and otherwise preparing to take such action; or
``(B) a recall of food under this Act.
``(b) Eligible Entities; Application.--
``(1) In general.--In this section, the term `eligible
entity' means an entity--
``(A) that is--
``(i) a State;
``(ii) a locality;
``(iii) a territory;
``(iv) an Indian tribe (as defined in section 4(e) of the
Indian Self-Determination and Education Assistance Act); or
``(v) a nonprofit food safety training entity that
collaborates with 1 or more institutions of higher education;
and
``(B) that submits an application to the Secretary at such
time, in such manner, and including such information as the
Secretary may reasonably require.
``(2) Contents.--Each application submitted under paragraph
(1) shall include--
``(A) an assurance that the eligible entity has developed
plans to engage in the types of activities described in
subsection (a);
``(B) a description of the types of activities to be funded
by the grant;
``(C) an itemization of how grant funds received under this
section will be expended;
``(D) a description of how grant activities will be
monitored; and
``(E) an agreement by the eligible entity to report
information required by the Secretary to conduct evaluations
under this section.
``(c) Limitations.--The funds provided under subsection (a)
shall be available to an eligible entity that receives a
grant under this section only to the extent such entity funds
the food safety programs of such entity independently of any
grant under this section in each year of the grant at a level
equal to the level of such funding in the previous year,
increased by the Consumer Price Index. Such non-Federal
matching funds may be provided directly or through donations
from public or private entities and may be in cash or in-
kind, fairly evaluated, including plant, equipment, or
services.
``(d) Additional Authority.--The Secretary may--
``(1) award a grant under this section in each subsequent
fiscal year without reapplication for a period of not more
than 3 years, provided the requirements of subsection (c) are
met for the previous fiscal year; and
``(2) award a grant under this section in a fiscal year for
which the requirement of subsection (c) has not been met only
if such requirement was not met because such funding was
diverted for response to 1 or more natural disasters or in
other extenuating circumstances that the Secretary may
determine appropriate.
``(e) Duration of Awards.--The Secretary may award grants
to an individual grant recipient under this section for
periods of not more than 3 years. In the event the Secretary
conducts a program evaluation, funding in the second year or
third year of the grant, where applicable, shall be
contingent on a successful program evaluation by the
Secretary after the first year.
``(f) Progress and Evaluation.--
``(1) In general.--The Secretary shall measure the status
and success of each grant program authorized under the FDA
Food Safety Modernization Act (and any amendment made by such
Act), including the grant program under this section. A
recipient of a grant described in the preceding sentence
shall, at the end of each grant year, provide the Secretary
with information on how grant funds were spent and the status
of the efforts by such recipient to enhance food safety. To
the extent practicable, the Secretary shall take the
performance of such a grant recipient into account when
determining whether to continue funding for such recipient.
``(2) No duplication.--In carrying out paragraph (1), the
Secretary shall not duplicate the efforts of the Secretary
under other provisions of this Act or the FDA Food Safety
Modernization Act that require measurement and review of the
activities of grant recipients under either such Act.
``(g) Supplement Not Supplant.--Grant funds received under
this section shall be used to supplement, and not supplant,
non-Federal funds and any other Federal funds available to
carry out the activities described in this section.
``(h) Authorization of Appropriations.--For the purpose of
making grants under this section, there are authorized to be
appropriated such sums as may be necessary for fiscal years
2011 through 2015.''.
(b) Centers of Excellence.--Part P of the Public Health
Service Act (42 U.S.C. 280g et seq.) is amended by adding at
the end the following:
``SEC. 399V-5. FOOD SAFETY INTEGRATED CENTERS OF EXCELLENCE.
``(a) In General.--Not later than 1 year after the date of
enactment of the FDA Food Safety Modernization Act, the
Secretary, acting through the Director of the Centers for
Disease Control and Prevention and in consultation with the
working group described in subsection (b)(2), shall designate
5 Integrated Food Safety Centers of Excellence (referred to
in this section as the `Centers of Excellence') to serve as
resources for Federal, State, and local public health
professionals to respond to foodborne illness outbreaks. The
Centers of Excellence shall be headquartered at selected
State health departments.
[[Page H8879]]
``(b) Selection of Centers of Excellence.--
``(1) Eligible entities.--To be eligible to be designated
as a Center of Excellence under subsection (a), an entity
shall--
``(A) be a State health department;
``(B) partner with 1 or more institutions of higher
education that have demonstrated knowledge, expertise, and
meaningful experience with regional or national food
production, processing, and distribution, as well as
leadership in the laboratory, epidemiological, and
environmental detection and investigation of foodborne
illness; and
``(C) provide to the Secretary such information, at such
time, and in such manner, as the Secretary may require.
``(2) Working group.--Not later than 180 days after the
date of enactment of the FDA Food Safety Modernization Act,
the Secretary shall establish a diverse working group of
experts and stakeholders from Federal, State, and local food
safety and health agencies, the food industry, including food
retailers and food manufacturers, consumer organizations, and
academia to make recommendations to the Secretary regarding
designations of the Centers of Excellence.
``(3) Additional centers of excellence.--The Secretary may
designate eligible entities to be regional Food Safety
Centers of Excellence, in addition to the 5 Centers
designated under subsection (a).
``(c) Activities.--Under the leadership of the Director of
the Centers for Disease Control and Prevention, each Center
of Excellence shall be based out of a selected State health
department, which shall provide assistance to other regional,
State, and local departments of health through activities
that include--
``(1) providing resources, including timely information
concerning symptoms and tests, for frontline health
professionals interviewing individuals as part of routine
surveillance and outbreak investigations;
``(2) providing analysis of the timeliness and
effectiveness of foodborne disease surveillance and outbreak
response activities;
``(3) providing training for epidemiological and
environmental investigation of foodborne illness, including
suggestions for streamlining and standardizing the
investigation process;
``(4) establishing fellowships, stipends, and scholarships
to train future epidemiological and food-safety leaders and
to address critical workforce shortages;
``(5) training and coordinating State and local personnel;
``(6) strengthening capacity to participate in existing or
new foodborne illness surveillance and environmental
assessment information systems; and
``(7) conducting research and outreach activities focused
on increasing prevention, communication, and education
regarding food safety.
``(d) Report to Congress.--Not later than 2 years after the
date of enactment of the FDA Food Safety Modernization Act,
the Secretary shall submit to Congress a report that--
``(1) describes the effectiveness of the Centers of
Excellence; and
``(2) provides legislative recommendations or describes
additional resources required by the Centers of Excellence.
``(e) Authorization of Appropriations.--There is authorized
to be appropriated such sums as may be necessary to carry out
this section.
``(f) No Duplication of Effort.--In carrying out activities
of the Centers of Excellence or other programs under this
section, the Secretary shall not duplicate other Federal
foodborne illness response efforts.''.
SEC. 211. IMPROVING THE REPORTABLE FOOD REGISTRY.
(a) In General.--Section 417 (21 U.S.C. 350f) is amended--
(1) by redesignating subsections (f) through (k) as
subsections (i) through (n), respectively; and
(2) by inserting after subsection (e) the following:
``(f) Critical Information.--Except with respect to fruits
and vegetables that are raw agricultural commodities, not
more than 18 months after the date of enactment of the FDA
Food Safety Modernization Act, the Secretary may require a
responsible party to submit to the Secretary consumer-
oriented information regarding a reportable food, which shall
include--
``(1) a description of the article of food as provided in
subsection (e)(3);
``(2) as provided in subsection (e)(7), affected product
identification codes, such as UPC, SKU, or lot or batch
numbers sufficient for the consumer to identify the article
of food;
``(3) contact information for the responsible party as
provided in subsection (e)(8); and
``(4) any other information the Secretary determines is
necessary to enable a consumer to accurately identify whether
such consumer is in possession of the reportable food.
``(g) Grocery Store Notification.--
``(1) Action by secretary.--The Secretary shall--
``(A) prepare the critical information described under
subsection (f) for a reportable food as a standardized one-
page summary;
``(B) publish such one-page summary on the Internet website
of the Food and Drug Administration in a format that can be
easily printed by a grocery store for purposes of consumer
notification.
``(2) Action by grocery store.--A notification described
under paragraph (1)(B) shall include the date and time such
summary was posted on the Internet website of the Food and
Drug Administration.
``(h) Consumer Notification.--
``(1) In general.--If a grocery store sold a reportable
food that is the subject of the posting and such
establishment is part of chain of establishments with 15 or
more physical locations, then such establishment shall, not
later than 24 hours after a one page summary described in
subsection (g) is published, prominently display such summary
or the information from such summary via at least one of the
methods identified under paragraph (2) and maintain the
display for 14 days.
``(2) List of conspicuous locations.--Not more than 1 year
after the date of enactment of the FDA Food Safety
Modernization Act, the Secretary shall develop and publish a
list of acceptable conspicuous locations and manners, from
which grocery stores shall select at least one, for providing
the notification required in paragraph (1). Such list shall
include--
``(A) posting the notification at or near the register;
``(B) providing the location of the reportable food;
``(C) providing targeted recall information given to
customers upon purchase of a food; and
``(D) other such prominent and conspicuous locations and
manners utilized by grocery stores as of the date of the
enactment of the FDA Food Safety Modernization Act to provide
notice of such recalls to consumers as considered appropriate
by the Secretary.''.
(b) Prohibited Act.--Section 301 (21 U.S.C. 331), as
amended by section 206, is amended by adding at the end the
following:
``(yy) The knowing and willful failure to comply with the
notification requirement under section 417(h).''.
(c) Conforming Amendment.--Section 301(e) (21 U.S.C.
331(e)) is amended by striking ``417(g)'' and inserting
``417(j)''.
TITLE III--IMPROVING THE SAFETY OF IMPORTED FOOD
SEC. 301. FOREIGN SUPPLIER VERIFICATION PROGRAM.
(a) In General.--Chapter VIII (21 U.S.C. 381 et seq.) is
amended by adding at the end the following:
``SEC. 805. FOREIGN SUPPLIER VERIFICATION PROGRAM.
``(a) In General.--
``(1) Verification requirement.--Except as provided under
subsections (e) and (f), each importer shall perform risk-
based foreign supplier verification activities for the
purpose of verifying that the food imported by the importer
or agent of an importer is--
``(A) produced in compliance with the requirements of
section 418 or section 419, as appropriate; and
``(B) is not adulterated under section 402 or misbranded
under section 403(w).
``(2) Importer defined.--For purposes of this section, the
term `importer' means, with respect to an article of food--
``(A) the United States owner or consignee of the article
of food at the time of entry of such article into the United
States; or
``(B) in the case when there is no United States owner or
consignee as described in subparagraph (A), the United States
agent or representative of a foreign owner or consignee of
the article of food at the time of entry of such article into
the United States.
``(b) Guidance.--Not later than 1 year after the date of
enactment of the FDA Food Safety Modernization Act, the
Secretary shall issue guidance to assist importers in
developing foreign supplier verification programs.
``(c) Regulations.--
``(1) In general.--Not later than 1 year after the date of
enactment of the FDA Food Safety Modernization Act, the
Secretary shall promulgate regulations to provide for the
content of the foreign supplier verification program
established under subsection (a).
``(2) Requirements.--The regulations promulgated under
paragraph (1)--
``(A) shall require that the foreign supplier verification
program of each importer be adequate to provide assurances
that each foreign supplier to the importer produces the
imported food in compliance with--
``(i) processes and procedures, including reasonably
appropriate risk-based preventive controls, that provide the
same level of public health protection as those required
under section 418 or section 419 (taking into consideration
variances granted under section 419), as appropriate; and
``(ii) section 402 and section 403(w).
``(B) shall include such other requirements as the
Secretary deems necessary and appropriate to verify that food
imported into the United States is as safe as food produced
and sold within the United States.
``(3) Considerations.--In promulgating regulations under
this subsection, the Secretary shall, as appropriate, take
into account differences among importers and types of
imported foods, including based on the level of risk posed by
the imported food.
``(4) Activities.--Verification activities under a foreign
supplier verification program under this section may include
monitoring records for shipments, lot-by-lot certification of
compliance, annual on-site inspections, checking the hazard
analysis and risk-based preventive control plan of the
foreign supplier, and periodically testing and sampling
shipments.
``(d) Record Maintenance and Access.--Records of an
importer related to a foreign supplier verification program
shall be maintained for a period of not less than 2 years and
shall be made available promptly to a duly authorized
representative of the Secretary upon request.
``(e) Exemption of Seafood, Juice, and Low-acid Canned Food
Facilities in Compliance With HACCP.--This section shall not
apply to a facility if the owner, operator, or agent in
charge of such facility is required to comply with, and is in
compliance with, 1 of the following standards and regulations
with respect to such facility:
``(1) The Seafood Hazard Analysis Critical Control Points
Program of the Food and Drug Administration.
``(2) The Juice Hazard Analysis Critical Control Points
Program of the Food and Drug Administration.
[[Page H8880]]
``(3) The Thermally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers standards of the Food and Drug
Administration (or any successor standards).
The exemption under paragraph (3) shall apply only with
respect to microbiological hazards that are regulated under
the standards for Thermally Processed Low-Acid Foods Packaged
in Hermetically Sealed Containers under part 113 of chapter
21, Code of Federal Regulations (or any successor
regulations).
``(f) Additional Exemptions.--The Secretary, by notice
published in the Federal Register, shall establish an
exemption from the requirements of this section for articles
of food imported in small quantities for research and
evaluation purposes or for personal consumption, provided
that such foods are not intended for retail sale and are not
sold or distributed to the public.
``(g) Publication of List of Participants.--The Secretary
shall publish and maintain on the Internet Web site of the
Food and Drug Administration a current list that includes the
name of, location of, and other information deemed necessary
by the Secretary about, importers participating under this
section.''.
(b) Prohibited Act.--Section 301 (21 U.S.C. 331), as
amended by section 211, is amended by adding at the end the
following:
``(zz) The importation or offering for importation of a
food if the importer (as defined in section 805) does not
have in place a foreign supplier verification program in
compliance with such section 805.''.
(c) Imports.--Section 801(a) (21 U.S.C. 381(a)) is amended
by adding ``or the importer (as defined in section 805) is in
violation of such section 805'' after ``or in violation of
section 505''.
(d) Effective Date.--The amendments made by this section
shall take effect 2 years after the date of enactment of this
Act.
SEC. 302. VOLUNTARY QUALIFIED IMPORTER PROGRAM.
Chapter VIII (21 U.S.C. 381 et seq.), as amended by section
301, is amended by adding at the end the following:
``SEC. 806. VOLUNTARY QUALIFIED IMPORTER PROGRAM.
``(a) In General.--Beginning not later than 18 months after
the date of enactment of the FDA Food Safety Modernization
Act, the Secretary shall--
``(1) establish a program, in consultation with the
Secretary of Homeland Security--
``(A) to provide for the expedited review and importation
of food offered for importation by importers who have
voluntarily agreed to participate in such program; and
``(B) consistent with section 808, establish a process for
the issuance of a facility certification to accompany food
offered for importation by importers who have voluntarily
agreed to participate in such program; and
``(2) issue a guidance document related to participation
in, revocation of such participation in, reinstatement in,
and compliance with, such program.
``(b) Voluntary Participation.--An importer may request the
Secretary to provide for the expedited review and importation
of designated foods in accordance with the program
established by the Secretary under subsection (a).
``(c) Notice of Intent To Participate.--An importer that
intends to participate in the program under this section in a
fiscal year shall submit a notice and application to the
Secretary of such intent at the time and in a manner
established by the Secretary.
``(d) Eligibility.--Eligibility shall be limited to an
importer offering food for importation from a facility that
has a certification described in subsection (a). In reviewing
the applications and making determinations on such
applications, the Secretary shall consider the risk of the
food to be imported based on factors, such as the following:
``(1) The known safety risks of the food to be imported.
``(2) The compliance history of foreign suppliers used by
the importer, as appropriate.
``(3) The capability of the regulatory system of the
country of export to ensure compliance with United States
food safety standards for a designated food.
``(4) The compliance of the importer with the requirements
of section 805.
``(5) The recordkeeping, testing, inspections and audits of
facilities, traceability of articles of food, temperature
controls, and sourcing practices of the importer.
``(6) The potential risk for intentional adulteration of
the food.
``(7) Any other factor that the Secretary determines
appropriate.
``(e) Review and Revocation.--Any importer qualified by the
Secretary in accordance with the eligibility criteria set
forth in this section shall be reevaluated not less often
than once every 3 years and the Secretary shall promptly
revoke the qualified importer status of any importer found
not to be in compliance with such criteria.
``(f) False Statements.--Any statement or representation
made by an importer to the Secretary shall be subject to
section 1001 of title 18, United States Code.
``(g) Definition.--For purposes of this section, the term
`importer' means the person that brings food, or causes food
to be brought, from a foreign country into the customs
territory of the United States.''.
SEC. 303. AUTHORITY TO REQUIRE IMPORT CERTIFICATIONS FOR
FOOD.
(a) In General.--Section 801(a) (21 U.S.C. 381(a)) is
amended by inserting after the third sentence the following:
``With respect to an article of food, if importation of such
food is subject to, but not compliant with, the requirement
under subsection (q) that such food be accompanied by a
certification or other assurance that the food meets
applicable requirements of this Act, then such article shall
be refused admission.''.
(b) Addition of Certification Requirement.--Section 801 (21
U.S.C. 381) is amended by adding at the end the following new
subsection:
``(q) Certifications Concerning Imported Foods.--
``(1) In general.--The Secretary may require, as a
condition of granting admission to an article of food
imported or offered for import into the United States, that
an entity described in paragraph (3) provide a certification,
or such other assurances as the Secretary determines
appropriate, that the article of food complies with
applicable requirements of this Act. Such certification or
assurances may be provided in the form of shipment-specific
certificates, a listing of certified facilities that
manufacture, process, pack, or hold such food, or in such
other form as the Secretary may specify.
``(2) Factors to be considered in requiring
certification.--The Secretary shall base the determination
that an article of food is required to have a certification
described in paragraph (1) on the risk of the food,
including--
``(A) known safety risks associated with the food;
``(B) known food safety risks associated with the country,
territory, or region of origin of the food;
``(C) a finding by the Secretary, supported by scientific,
risk-based evidence, that--
``(i) the food safety programs, systems, and standards in
the country, territory, or region of origin of the food are
inadequate to ensure that the article of food is as safe as a
similar article of food that is manufactured, processed,
packed, or held in the United States in accordance with the
requirements of this Act; and
``(ii) the certification would assist the Secretary in
determining whether to refuse or admit the article of food
under subsection (a); and
``(D) information submitted to the Secretary in accordance
with the process established in paragraph (7).
``(3) Certifying entities.--For purposes of paragraph (1),
entities that shall provide the certification or assurances
described in such paragraph are--
``(A) an agency or a representative of the government of
the country from which the article of food at issue
originated, as designated by the Secretary; or
``(B) such other persons or entities accredited pursuant to
section 808 to provide such certification or assurance.
``(4) Renewal and refusal of certifications.--The Secretary
may--
``(A) require that any certification or other assurance
provided by an entity specified in paragraph (2) be renewed
by such entity at such times as the Secretary determines
appropriate; and
``(B) refuse to accept any certification or assurance if
the Secretary determines that such certification or assurance
is not valid or reliable.
``(5) Electronic submission.--The Secretary shall provide
for the electronic submission of certifications under this
subsection.
``(6) False statements.--Any statement or representation
made by an entity described in paragraph (2) to the Secretary
shall be subject to section 1001 of title 18, United States
Code.
``(7) Assessment of food safety programs, systems, and
standards.--If the Secretary determines that the food safety
programs, systems, and standards in a foreign region,
country, or territory are inadequate to ensure that an
article of food is as safe as a similar article of food that
is manufactured, processed, packed, or held in the United
States in accordance with the requirements of this Act, the
Secretary shall, to the extent practicable, identify such
inadequacies and establish a process by which the foreign
region, country, or territory may inform the Secretary of
improvements made to such food safety program, system, or
standard and demonstrate that those controls are adequate to
ensure that an article of food is as safe as a similar
article of food that is manufactured, processed, packed, or
held in the United States in accordance with the requirements
of this Act.''.
(c) Conforming Technical Amendment.--Section 801(b) (21
U.S.C. 381(b)) is amended in the second sentence by striking
``with respect to an article included within the provision of
the fourth sentence of subsection (a)'' and inserting ``with
respect to an article described in subsection (a) relating to
the requirements of sections 760 or 761,''.
(d) No Limit on Authority.--Nothing in the amendments made
by this section shall limit the authority of the Secretary to
conduct inspections of imported food or to take such other
steps as the Secretary deems appropriate to determine the
admissibility of imported food.
SEC. 304. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.
(a) In General.--Section 801(m)(1) (21 U.S.C. 381(m)(1)) is
amended by inserting ``any country to which the article has
been refused entry;'' after ``the country from which the
article is shipped;''.
(b) Regulations.--Not later than 120 days after the date of
enactment of this Act, the Secretary shall issue an interim
final rule amending subpart I of part 1 of title 21, Code of
Federal Regulations, to implement the amendment made by this
section.
(c) Effective Date.--The amendment made by this section
shall take effect 180 days after the date of enactment of
this Act.
SEC. 305. BUILDING CAPACITY OF FOREIGN GOVERNMENTS WITH
RESPECT TO FOOD SAFETY.
(a) In General.--The Secretary shall, not later than 2
years of the date of enactment of this Act, develop a
comprehensive plan to expand the technical, scientific, and
regulatory
[[Page H8881]]
food safety capacity of foreign governments, and their
respective food industries, from which foods are exported to
the United States.
(b) Consultation.--In developing the plan under subsection
(a), the Secretary shall consult with the Secretary of
Agriculture, Secretary of State, Secretary of the Treasury,
the Secretary of Homeland Security, the United States Trade
Representative, and the Secretary of Commerce,
representatives of the food industry, appropriate foreign
government officials, nongovernmental organizations that
represent the interests of consumers, and other stakeholders.
(c) Plan.--The plan developed under subsection (a) shall
include, as appropriate, the following:
(1) Recommendations for bilateral and multilateral
arrangements and agreements, including provisions to provide
for responsibility of exporting countries to ensure the
safety of food.
(2) Provisions for secure electronic data sharing.
(3) Provisions for mutual recognition of inspection
reports.
(4) Training of foreign governments and food producers on
United States requirements for safe food.
(5) Recommendations on whether and how to harmonize
requirements under the Codex Alimentarius.
(6) Provisions for the multilateral acceptance of
laboratory methods and testing and detection techniques.
(d) Rule of Construction.--Nothing in this section shall be
construed to affect the regulation of dietary supplements
under the Dietary Supplement Health and Education Act of 1994
(Public Law 103-417).
SEC. 306. INSPECTION OF FOREIGN FOOD FACILITIES.
(a) In General.--Chapter VIII (21 U.S.C. 381 et seq.), as
amended by section 302, is amended by inserting at the end
the following:
``SEC. 807. INSPECTION OF FOREIGN FOOD FACILITIES.
``(a) Inspection.--The Secretary--
``(1) may enter into arrangements and agreements with
foreign governments to facilitate the inspection of foreign
facilities registered under section 415; and
``(2) shall direct resources to inspections of foreign
facilities, suppliers, and food types, especially such
facilities, suppliers, and food types that present a high
risk (as identified by the Secretary), to help ensure the
safety and security of the food supply of the United States.
``(b) Effect of Inability To Inspect.--Notwithstanding any
other provision of law, food shall be refused admission into
the United States if it is from a foreign factory, warehouse,
or other establishment of which the owner, operator, or agent
in charge, or the government of the foreign country, refuses
to permit entry of United States inspectors or other
individuals duly designated by the Secretary, upon request,
to inspect such factory, warehouse, or other establishment.
For purposes of this subsection, such an owner, operator, or
agent in charge shall be considered to have refused an
inspection if such owner, operator, or agent in charge does
not permit an inspection of a factory, warehouse, or other
establishment during the 24-hour period after such request is
submitted, or after such other time period, as agreed upon by
the Secretary and the foreign factory, warehouse, or other
establishment.''.
(b) Inspection by the Secretary of Commerce.--
(1) In general.--The Secretary of Commerce, in coordination
with the Secretary of Health and Human Services, may send 1
or more inspectors to a country or facility of an exporter
from which seafood imported into the United States
originates. The inspectors shall assess practices and
processes used in connection with the farming, cultivation,
harvesting, preparation for market, or transportation of such
seafood and may provide technical assistance related to such
activities.
(2) Inspection report.--
(A) In general.--The Secretary of Health and Human
Services, in coordination with the Secretary of Commerce,
shall--
(i) prepare an inspection report for each inspection
conducted under paragraph (1);
(ii) provide the report to the country or exporter that is
the subject of the report; and
(iii) provide a 30-day period during which the country or
exporter may provide a rebuttal or other comments on the
findings of the report to the Secretary of Health and Human
Services.
(B) Distribution and use of report.--The Secretary of
Health and Human Services shall consider the inspection
reports described in subparagraph (A) in distributing
inspection resources under section 421 of the Federal Food,
Drug, and Cosmetic Act, as added by section 201.
SEC. 307. ACCREDITATION OF THIRD-PARTY AUDITORS.
Chapter VIII (21 U.S.C. 381 et seq.), as amended by section
306, is amended by adding at the end the following:
``SEC. 808. ACCREDITATION OF THIRD-PARTY AUDITORS.
``(a) Definitions.--In this section:
``(1) Audit agent.--The term `audit agent' means an
individual who is an employee or agent of an accredited
third-party auditor and, although not individually
accredited, is qualified to conduct food safety audits on
behalf of an accredited third-party auditor.
``(2) Accreditation body.--The term `accreditation body'
means an authority that performs accreditation of third-party
auditors.
``(3) Third-party auditor.--The term `third-party auditor'
means a foreign government, agency of a foreign government,
foreign cooperative, or any other third party, as the
Secretary determines appropriate in accordance with the model
standards described in subsection (b)(2), that is eligible to
be considered for accreditation to conduct food safety audits
to certify that eligible entities meet the applicable
requirements of this section. A third-party auditor may be a
single individual. A third-party auditor may employ or use
audit agents to help conduct consultative and regulatory
audits.
``(4) Accredited third-party auditor.--The term `accredited
third-party auditor' means a third-party auditor accredited
by an accreditation body to conduct audits of eligible
entities to certify that such eligible entities meet the
applicable requirements of this section. An accredited third-
party auditor may be an individual who conducts food safety
audits to certify that eligible entities meet the applicable
requirements of this section.
``(5) Consultative audit.--The term `consultative audit'
means an audit of an eligible entity--
``(A) to determine whether such entity is in compliance
with the provisions of this Act and with applicable industry
standards and practices; and
``(B) the results of which are for internal purposes only.
``(6) Eligible entity.--The term `eligible entity' means a
foreign entity, including a foreign facility registered under
section 415, in the food import supply chain that chooses to
be audited by an accredited third-party auditor or the audit
agent of such accredited third-party auditor.
``(7) Regulatory audit.--The term `regulatory audit' means
an audit of an eligible entity--
``(A) to determine whether such entity is in compliance
with the provisions of this Act; and
``(B) the results of which determine--
``(i) whether an article of food manufactured, processed,
packed, or held by such entity is eligible to receive a food
certification under section 801(q); or
``(ii) whether a facility is eligible to receive a facility
certification under section 806(a) for purposes of
participating in the program under section 806.
``(b) Accreditation System.--
``(1) Accreditation bodies.--
``(A) Recognition of accreditation bodies.--
``(i) In general.--Not later than 2 years after the date of
enactment of the FDA Food Safety Modernization Act, the
Secretary shall establish a system for the recognition of
accreditation bodies that accredit third-party auditors to
certify that eligible entities meet the applicable
requirements of this section.
``(ii) Direct accreditation.--If, by the date that is 2
years after the date of establishment of the system described
in clause (i), the Secretary has not identified and
recognized an accreditation body to meet the requirements of
this section, the Secretary may directly accredit third-party
auditors.
``(B) Notification.--Each accreditation body recognized by
the Secretary shall submit to the Secretary a list of all
accredited third-party auditors accredited by such body and
the audit agents of such auditors.
``(C) Revocation of recognition as an accreditation body.--
The Secretary shall promptly revoke the recognition of any
accreditation body found not to be in compliance with the
requirements of this section.
``(D) Reinstatement.--The Secretary shall establish
procedures to reinstate recognition of an accreditation body
if the Secretary determines, based on evidence presented by
such accreditation body, that revocation was inappropriate or
that the body meets the requirements for recognition under
this section.
``(2) Model accreditation standards.--Not later than 18
months after the date of enactment of the FDA Food Safety
Modernization Act, the Secretary shall develop model
standards, including requirements for regulatory audit
reports, and each recognized accreditation body shall ensure
that third-party auditors and audit agents of such auditors
meet such standards in order to qualify such third-party
auditors as accredited third-party auditors under this
section. In developing the model standards, the Secretary
shall look to standards in place on the date of the enactment
of this section for guidance, to avoid unnecessary
duplication of efforts and costs.
``(c) Third-party Auditors.--
``(1) Requirements for accreditation as a third-party
auditor.--
``(A) Foreign governments.--Prior to accrediting a foreign
government or an agency of a foreign government as an
accredited third-party auditor, the accreditation body (or,
in the case of direct accreditation under subsection
(b)(1)(A)(ii), the Secretary) shall perform such reviews and
audits of food safety programs, systems, and standards of the
government or agency of the government as the Secretary deems
necessary, including requirements under the model standards
developed under subsection (b)(2), to determine that the
foreign government or agency of the foreign government is
capable of adequately ensuring that eligible entities or
foods certified by such government or agency meet the
requirements of this Act with respect to food manufactured,
processed, packed, or held for import into the United States.
``(B) Foreign cooperatives and other third parties.--Prior
to accrediting a foreign cooperative that aggregates the
products of growers or processors, or any other third party
to be an accredited third-party auditor, the accreditation
body (or, in the case of direct accreditation under
subsection (b)(1)(A)(ii), the Secretary) shall perform such
reviews and audits of the training and qualifications of
audit agents used by that cooperative or party and conduct
such reviews of internal systems and such other investigation
of the cooperative or party as the Secretary deems necessary,
including requirements under the model standards developed
[[Page H8882]]
under subsection (b)(2), to determine that each eligible
entity certified by the cooperative or party has systems and
standards in use to ensure that such entity or food meets the
requirements of this Act.
``(2) Requirement to issue certification of eligible
entities or foods.--
``(A) In general.--An accreditation body (or, in the case
of direct accreditation under subsection (b)(1)(A)(ii), the
Secretary) may not accredit a third-party auditor unless such
third-party auditor agrees to issue a written and, as
appropriate, electronic food certification, described in
section 801(q), or facility certification under section
806(a), as appropriate, to accompany each food shipment for
import into the United States from an eligible entity,
subject to requirements set forth by the Secretary. Such
written or electronic certification may be included with
other documentation regarding such food shipment. The
Secretary shall consider certifications under section 801(q)
and participation in the voluntary qualified importer program
described in section 806 when targeting inspection resources
under section 421.
``(B) Purpose of certification.--The Secretary shall use
certification provided by accredited third-party auditors
to--
``(i) determine, in conjunction with any other assurances
the Secretary may require under section 801(q), whether a
food satisfies the requirements of such section; and
``(ii) determine whether a facility is eligible to be a
facility from which food may be offered for import under the
voluntary qualified importer program under section 806.
``(C) Requirements for issuing certification.--
``(i) In general.--An accredited third-party auditor shall
issue a food certification under section 801(q) or a facility
certification described under subparagraph (B) only after
conducting a regulatory audit and such other activities that
may be necessary to establish compliance with the
requirements of such sections.
``(ii) Provision of certification.--Only an accredited
third-party auditor or the Secretary may provide a facility
certification under section 806(a). Only those parties
described in 801(q)(3) or the Secretary may provide a food
certification under 301(g).
``(3) Audit report submission requirements.--
``(A) Requirements in general.--As a condition of
accreditation, not later than 45 days after conducting an
audit, an accredited third-party auditor or audit agent of
such auditor shall prepare, and, in the case of a regulatory
audit, submit, the audit report for each audit conducted, in
a form and manner designated by the Secretary, which shall
include--
``(i) the identity of the persons at the audited eligible
entity responsible for compliance with food safety
requirements;
``(ii) the dates of the audit;
``(iii) the scope of the audit; and
``(iv) any other information required by the Secretary that
relates to or may influence an assessment of compliance with
this Act.
``(B) Records.--Following any accreditation of a third-
party auditor, the Secretary may, at any time, require the
accredited third-party auditor to submit to the Secretary an
onsite audit report and such other reports or documents
required as part of the audit process, for any eligible
entity certified by the third-party auditor or audit agent of
such auditor. Such report may include documentation that the
eligible entity is in compliance with any applicable
registration requirements.
``(C) Limitation.--The requirement under subparagraph (B)
shall not include any report or other documents resulting
from a consultative audit by the accredited third-party
auditor, except that the Secretary may access the results of
a consultative audit in accordance with section 414.
``(4) Requirements of accredited third-party auditors and
audit agents of such auditors.--
``(A) Risks to public health.--If, at any time during an
audit, an accredited third-party auditor or audit agent of
such auditor discovers a condition that could cause or
contribute to a serious risk to the public health, such
auditor shall immediately notify the Secretary of--
``(i) the identification of the eligible entity subject to
the audit; and
``(ii) such condition.
``(B) Types of audits.--An accredited third-party auditor
or audit agent of such auditor may perform consultative and
regulatory audits of eligible entities.
``(C) Limitations.--
``(i) In general.--An accredited third party auditor may
not perform a regulatory audit of an eligible entity if such
agent has performed a consultative audit or a regulatory
audit of such eligible entity during the previous 13-month
period.
``(ii) Waiver.--The Secretary may waive the application of
clause (i) if the Secretary determines that there is
insufficient access to accredited third-party auditors in a
country or region.
``(5) Conflicts of interest.--
``(A) Third-party auditors.--An accredited third-party
auditor shall--
``(i) not be owned, managed, or controlled by any person
that owns or operates an eligible entity to be certified by
such auditor;
``(ii) in carrying out audits of eligible entities under
this section, have procedures to ensure against the use of
any officer or employee of such auditor that has a financial
conflict of interest regarding an eligible entity to be
certified by such auditor; and
``(iii) annually make available to the Secretary
disclosures of the extent to which such auditor and the
officers and employees of such auditor have maintained
compliance with clauses (i) and (ii) relating to financial
conflicts of interest.
``(B) Audit agents.--An audit agent shall--
``(i) not own or operate an eligible entity to be audited
by such agent;
``(ii) in carrying out audits of eligible entities under
this section, have procedures to ensure that such agent does
not have a financial conflict of interest regarding an
eligible entity to be audited by such agent; and
``(iii) annually make available to the Secretary
disclosures of the extent to which such agent has maintained
compliance with clauses (i) and (ii) relating to financial
conflicts of interest.
``(C) Regulations.--The Secretary shall promulgate
regulations not later than 18 months after the date of
enactment of the FDA Food Safety Modernization Act to
implement this section and to ensure that there are
protections against conflicts of interest between an
accredited third-party auditor and the eligible entity to be
certified by such auditor or audited by such audit agent.
Such regulations shall include--
``(i) requiring that audits performed under this section be
unannounced;
``(ii) a structure to decrease the potential for conflicts
of interest, including timing and public disclosure, for fees
paid by eligible entities to accredited third-party auditors;
and
``(iii) appropriate limits on financial affiliations
between an accredited third-party auditor or audit agents of
such auditor and any person that owns or operates an eligible
entity to be certified by such auditor, as described in
subparagraphs (A) and (B).
``(6) Withdrawal of accreditation.--
``(A) In general.--The Secretary shall withdraw
accreditation from an accredited third-party auditor--
``(i) if food certified under section 801(q) or from a
facility certified under paragraph (2)(B) by such third-party
auditor is linked to an outbreak of foodborne illness that
has a reasonable probability of causing serious adverse
health consequences or death in humans or animals;
``(ii) following an evaluation and finding by the Secretary
that the third-party auditor no longer meets the requirements
for accreditation; or
``(iii) following a refusal to allow United States
officials to conduct such audits and investigations as may be
necessary to ensure continued compliance with the
requirements set forth in this section.
``(B) Additional basis for withdrawal of accreditation.--
The Secretary may withdraw accreditation from an accredited
third-party auditor in the case that such third-party auditor
is accredited by an accreditation body for which recognition
as an accreditation body under subsection (b)(1)(C) is
revoked, if the Secretary determines that there is good cause
for the withdrawal.
``(C) Exception.--The Secretary may waive the application
of subparagraph (A)(i) if the Secretary--
``(i) conducts an investigation of the material facts
related to the outbreak of human or animal illness; and
``(ii) reviews the steps or actions taken by the third
party auditor to justify the certification and determines
that the accredited third-party auditor satisfied the
requirements under section 801(q) of certifying the food, or
the requirements under paragraph (2)(B) of certifying the
entity.
``(7) Reaccreditation.--The Secretary shall establish
procedures to reinstate the accreditation of a third-party
auditor for which accreditation has been withdrawn under
paragraph (6)--
``(A) if the Secretary determines, based on evidence
presented, that the third-party auditor satisfies the
requirements of this section and adequate grounds for
revocation no longer exist; and
``(B) in the case of a third-party auditor accredited by an
accreditation body for which recognition as an accreditation
body under subsection (b)(1)(C) is revoked--
``(i) if the third-party auditor becomes accredited not
later than 1 year after revocation of accreditation under
paragraph (6)(A), through direct accreditation under
subsection (b)(1)(A)(ii) or by an accreditation body in good
standing; or
``(ii) under such conditions as the Secretary may require
for a third-party auditor under paragraph (6)(B).
``(8) Neutralizing costs.--The Secretary shall establish by
regulation a reimbursement (user fee) program, similar to the
method described in section 203(h) of the Agriculture
Marketing Act of 1946, by which the Secretary assesses fees
and requires accredited third-party auditors and audit agents
to reimburse the Food and Drug Administration for the work
performed to establish and administer the accreditation
system under this section. The Secretary shall make operating
this program revenue-neutral and shall not generate surplus
revenue from such a reimbursement mechanism. Fees authorized
under this paragraph shall be collected and available for
obligation only to the extent and in the amount provided in
advance in appropriation Acts. Such fees are authorized to
remain available until expended.
``(d) Recertification of Eligible Entities.--An eligible
entity shall apply for annual recertification by an
accredited third-party auditor if such entity--
``(1) intends to participate in voluntary qualified
importer program under section 806; or
``(2) is required to provide to the Secretary a
certification under section 801(q) for any food from such
entity.
``(e) False Statements.--Any statement or representation
made--
``(1) by an employee or agent of an eligible entity to an
accredited third-party auditor or audit agent; or
``(2) by an accredited third-party auditor to the
Secretary,
[[Page H8883]]
shall be subject to section 1001 of title 18, United States
Code.
``(f) Monitoring.--To ensure compliance with the
requirements of this section, the Secretary shall--
``(1) periodically, or at least once every 4 years,
reevaluate the accreditation bodies described in subsection
(b)(1);
``(2) periodically, or at least once every 4 years,
evaluate the performance of each accredited third-party
auditor, through the review of regulatory audit reports by
such auditors, the compliance history as available of
eligible entities certified by such auditors, and any other
measures deemed necessary by the Secretary;
``(3) at any time, conduct an onsite audit of any eligible
entity certified by an accredited third-party auditor, with
or without the auditor present; and
``(4) take any other measures deemed necessary by the
Secretary.
``(g) Publicly Available Registry.--The Secretary shall
establish a publicly available registry of accreditation
bodies and of accredited third-party auditors, including the
name of, contact information for, and other information
deemed necessary by the Secretary about such bodies and
auditors.
``(h) Limitations.--
``(1) No effect on section 704 inspections.--The audits
performed under this section shall not be considered
inspections under section 704.
``(2) No effect on inspection authority.--Nothing in this
section affects the authority of the Secretary to inspect any
eligible entity pursuant to this Act.''.
SEC. 308. FOREIGN OFFICES OF THE FOOD AND DRUG
ADMINISTRATION.
(a) In General.--The Secretary shall establish offices of
the Food and Drug Administration in foreign countries
selected by the Secretary, to provide assistance to the
appropriate governmental entities of such countries with
respect to measures to provide for the safety of articles of
food and other products regulated by the Food and Drug
Administration exported by such country to the United States,
including by directly conducting risk-based inspections of
such articles and supporting such inspections by such
governmental entity.
(b) Consultation.--In establishing the foreign offices
described in subsection (a), the Secretary shall consult with
the Secretary of State, the Secretary of Homeland Security,
and the United States Trade Representative.
(c) Report.--Not later than October 1, 2011, the Secretary
shall submit to Congress a report on the basis for the
selection by the Secretary of the foreign countries in which
the Secretary established offices, the progress which such
offices have made with respect to assisting the governments
of such countries in providing for the safety of articles of
food and other products regulated by the Food and Drug
Administration exported to the United States, and the plans
of the Secretary for establishing additional foreign offices
of the Food and Drug Administration, as appropriate.
SEC. 309. SMUGGLED FOOD.
(a) In General.--Not later than 180 days after the
enactment of this Act, the Secretary shall, in coordination
with the Secretary of Homeland Security, develop and
implement a strategy to better identify smuggled food and
prevent entry of such food into the United States.
(b) Notification to Homeland Security.--Not later than 10
days after the Secretary identifies a smuggled food that the
Secretary believes would cause serious adverse health
consequences or death to humans or animals, the Secretary
shall provide to the Secretary of Homeland Security a
notification under section 417(n) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 350f(k)) describing the smuggled
food and, if available, the names of the individuals or
entities that attempted to import such food into the United
States.
(c) Public Notification.--If the Secretary--
(1) identifies a smuggled food;
(2) reasonably believes exposure to the food would cause
serious adverse health consequences or death to humans or
animals; and
(3) reasonably believes that the food has entered domestic
commerce and is likely to be consumed,
the Secretary shall promptly issue a press release describing
that food and shall use other emergency communication or
recall networks, as appropriate, to warn consumers and
vendors about the potential threat.
(d) Effect of Section.--Nothing in this section shall
affect the authority of the Secretary to issue public
notifications under other circumstances.
(e) Definition.--In this subsection, the term ``smuggled
food'' means any food that a person introduces into the
United States through fraudulent means or with the intent to
defraud or mislead.
TITLE IV--MISCELLANEOUS PROVISIONS
SEC. 401. FUNDING FOR FOOD SAFETY.
(a) In General.--There are authorized to be appropriated to
carry out the activities of the Center for Food Safety and
Applied Nutrition, the Center for Veterinary Medicine, and
related field activities in the Office of Regulatory Affairs
of the Food and Drug Administration such sums as may be
necessary for fiscal years 2011 through 2015.
(b) Increased Number of Field Staff.--
(1) In general.--To carry out the activities of the Center
for Food Safety and Applied Nutrition, the Center for
Veterinary Medicine, and related field activities of the
Office of Regulatory Affairs of the Food and Drug
Administration, the Secretary of Health and Human Services
shall increase the field staff of such Centers and Office
with a goal of not fewer than--
(A) 4,000 staff members in fiscal year 2011;
(B) 4,200 staff members in fiscal year 2012;
(C) 4,600 staff members in fiscal year 2013; and
(D) 5,000 staff members in fiscal year 2014.
(2) Field staff for food defense.--The goal under paragraph
(1) shall include an increase of 150 employees by fiscal year
2011 to--
(A) provide additional detection of and response to food
defense threats; and
(B) detect, track, and remove smuggled food (as defined in
section 309) from commerce.
SEC. 402. EMPLOYEE PROTECTIONS.
Chapter X of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 391 et seq.), as amended by section 209, is further
amended by adding at the end the following:
``SEC. 1012. EMPLOYEE PROTECTIONS.
``(a) In General.--No entity engaged in the manufacture,
processing, packing, transporting, distribution, reception,
holding, or importation of food may discharge an employee or
otherwise discriminate against an employee with respect to
compensation, terms, conditions, or privileges of employment
because the employee, whether at the employee's initiative or
in the ordinary course of the employee's duties (or any
person acting pursuant to a request of the employee)--
``(1) provided, caused to be provided, or is about to
provide or cause to be provided to the employer, the Federal
Government, or the attorney general of a State information
relating to any violation of, or any act or omission the
employee reasonably believes to be a violation of any
provision of this Act or any order, rule, regulation,
standard, or ban under this Act, or any order, rule,
regulation, standard, or ban under this Act;
``(2) testified or is about to testify in a proceeding
concerning such violation;
``(3) assisted or participated or is about to assist or
participate in such a proceeding; or
``(4) objected to, or refused to participate in, any
activity, policy, practice, or assigned task that the
employee (or other such person) reasonably believed to be in
violation of any provision of this Act, or any order, rule,
regulation, standard, or ban under this Act.
``(b) Process.--
``(1) In general.--A person who believes that he or she has
been discharged or otherwise discriminated against by any
person in violation of subsection (a) may, not later than 180
days after the date on which such violation occurs, file (or
have any person file on his or her behalf) a complaint with
the Secretary of Labor (referred to in this section as the
`Secretary') alleging such discharge or discrimination and
identifying the person responsible for such act. Upon receipt
of such a complaint, the Secretary shall notify, in writing,
the person named in the complaint of the filing of the
complaint, of the allegations contained in the complaint, of
the substance of evidence supporting the complaint, and of
the opportunities that will be afforded to such person under
paragraph (2).
``(2) Investigation.--
``(A) In general.--Not later than 60 days after the date of
receipt of a complaint filed under paragraph (1) and after
affording the complainant and the person named in the
complaint an opportunity to submit to the Secretary a written
response to the complaint and an opportunity to meet with a
representative of the Secretary to present statements from
witnesses, the Secretary shall initiate an investigation and
determine whether there is reasonable cause to believe that
the complaint has merit and notify, in writing, the
complainant and the person alleged to have committed a
violation of subsection (a) of the Secretary's findings.
``(B) Reasonable cause found; preliminary order.--If the
Secretary concludes that there is reasonable cause to believe
that a violation of subsection (a) has occurred, the
Secretary shall accompany the Secretary's findings with a
preliminary order providing the relief prescribed by
paragraph (3)(B). Not later than 30 days after the date of
notification of findings under this paragraph, the person
alleged to have committed the violation or the complainant
may file objections to the findings or preliminary order, or
both, and request a hearing on the record. The filing of such
objections shall not operate to stay any reinstatement remedy
contained in the preliminary order. Any such hearing shall be
conducted expeditiously. If a hearing is not requested in
such 30-day period, the preliminary order shall be deemed a
final order that is not subject to judicial review.
``(C) Dismissal of complaint.--
``(i) Standard for complainant.--The Secretary shall
dismiss a complaint filed under this subsection and shall not
conduct an investigation otherwise required under
subparagraph (A) unless the complainant makes a prima facie
showing that any behavior described in paragraphs (1) through
(4) of subsection (a) was a contributing factor in the
unfavorable personnel action alleged in the complaint.
``(ii) Standard for employer.--Notwithstanding a finding by
the Secretary that the complainant has made the showing
required under clause (i), no investigation otherwise
required under subparagraph (A) shall be conducted if the
employer demonstrates, by clear and convincing evidence, that
the employer would have taken the same unfavorable personnel
action in the absence of that behavior.
``(iii) Violation standard.--The Secretary may determine
that a violation of subsection (a) has occurred only if the
complainant demonstrates that any behavior described in
paragraphs (1) through (4) of subsection (a) was a
contributing factor in the unfavorable personnel action
alleged in the complaint.
``(iv) Relief standard.--Relief may not be ordered under
subparagraph (A) if the employer demonstrates by clear and
convincing evidence that the employer would have taken the
same unfavorable personnel action in the absence of that
behavior.
``(3) Final order.--
``(A) In general.--Not later than 120 days after the date
of conclusion of any hearing under paragraph (2), the
Secretary shall issue a
[[Page H8884]]
final order providing the relief prescribed by this paragraph
or denying the complaint. At any time before issuance of a
final order, a proceeding under this subsection may be
terminated on the basis of a settlement agreement entered
into by the Secretary, the complainant, and the person
alleged to have committed the violation.
``(B) Content of order.--If, in response to a complaint
filed under paragraph (1), the Secretary determines that a
violation of subsection (a) has occurred, the Secretary shall
order the person who committed such violation--
``(i) to take affirmative action to abate the violation;
``(ii) to reinstate the complainant to his or her former
position together with compensation (including back pay) and
restore the terms, conditions, and privileges associated with
his or her employment; and
``(iii) to provide compensatory damages to the complainant.
``(C) Penalty.--If such an order is issued under this
paragraph, the Secretary, at the request of the complainant,
shall assess against the person against whom the order is
issued a sum equal to the aggregate amount of all costs and
expenses (including attorneys' and expert witness fees)
reasonably incurred, as determined by the Secretary, by the
complainant for, or in connection with, the bringing of the
complaint upon which the order was issued.
``(D) Bad faith claim.--If the Secretary finds that a
complaint under paragraph (1) is frivolous or has been
brought in bad faith, the Secretary may award to the
prevailing employer a reasonable attorneys' fee, not
exceeding $1,000, to be paid by the complainant.
``(4) Action in court.--
``(A) In general.--If the Secretary has not issued a final
decision within 210 days after the filing of the complaint,
or within 90 days after receiving a written determination,
the complainant may bring an action at law or equity for de
novo review in the appropriate district court of the United
States with jurisdiction, which shall have jurisdiction over
such an action without regard to the amount in controversy,
and which action shall, at the request of either party to
such action, be tried by the court with a jury. The
proceedings shall be governed by the same legal burdens of
proof specified in paragraph (2)(C).
``(B) Relief.--The court shall have jurisdiction to grant
all relief necessary to make the employee whole, including
injunctive relief and compensatory damages, including--
``(i) reinstatement with the same seniority status that the
employee would have had, but for the discharge or
discrimination;
``(ii) the amount of back pay, with interest; and
``(iii) compensation for any special damages sustained as a
result of the discharge or discrimination, including
litigation costs, expert witness fees, and reasonable
attorney's fees.
``(5) Review.--
``(A) In general.--Unless the complainant brings an action
under paragraph (4), any person adversely affected or
aggrieved by a final order issued under paragraph (3) may
obtain review of the order in the United States Court of
Appeals for the circuit in which the violation, with respect
to which the order was issued, allegedly occurred or the
circuit in which the complainant resided on the date of such
violation. The petition for review must be filed not later
than 60 days after the date of the issuance of the final
order of the Secretary. Review shall conform to chapter 7 of
title 5, United States Code. The commencement of proceedings
under this subparagraph shall not, unless ordered by the
court, operate as a stay of the order.
``(B) No judicial review.--An order of the Secretary with
respect to which review could have been obtained under
subparagraph (A) shall not be subject to judicial review in
any criminal or other civil proceeding.
``(6) Failure to comply with order.--Whenever any person
has failed to comply with an order issued under paragraph
(3), the Secretary may file a civil action in the United
States district court for the district in which the violation
was found to occur, or in the United States district court
for the District of Columbia, to enforce such order. In
actions brought under this paragraph, the district courts
shall have jurisdiction to grant all appropriate relief
including, but not limited to, injunctive relief and
compensatory damages.
``(7) Civil action to require compliance.--
``(A) In general.--A person on whose behalf an order was
issued under paragraph (3) may commence a civil action
against the person to whom such order was issued to require
compliance with such order. The appropriate United States
district court shall have jurisdiction, without regard to the
amount in controversy or the citizenship of the parties, to
enforce such order.
``(B) Award.--The court, in issuing any final order under
this paragraph, may award costs of litigation (including
reasonable attorneys' and expert witness fees) to any party
whenever the court determines such award is appropriate.
``(c) Effect of Section.--
``(1) Other laws.--Nothing in this section preempts or
diminishes any other safeguards against discrimination,
demotion, discharge, suspension, threats, harassment,
reprimand, retaliation, or any other manner of discrimination
provided by Federal or State law.
``(2) Rights of employees.--Nothing in this section shall
be construed to diminish the rights, privileges, or remedies
of any employee under any Federal or State law or under any
collective bargaining agreement. The rights and remedies in
this section may not be waived by any agreement, policy,
form, or condition of employment.
``(d) Enforcement.--Any nondiscretionary duty imposed by
this section shall be enforceable in a mandamus proceeding
brought under section 1361 of title 28, United States Code.
``(e) Limitation.--Subsection (a) shall not apply with
respect to an employee of an entity engaged in the
manufacture, processing, packing, transporting, distribution,
reception, holding, or importation of food who, acting
without direction from such entity (or such entity's agent),
deliberately causes a violation of any requirement relating
to any violation or alleged violation of any order, rule,
regulation, standard, or ban under this Act.''.
SEC. 403. JURISDICTION; AUTHORITIES.
Nothing in this Act, or an amendment made by this Act,
shall be construed to--
(1) alter the jurisdiction between the Secretary of
Agriculture and the Secretary of Health and Human Services,
under applicable statutes, regulations, or agreements
regarding voluntary inspection of non-amenable species under
the Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et
seq.);
(2) alter the jurisdiction between the Alcohol and Tobacco
Tax and Trade Bureau and the Secretary of Health and Human
Services, under applicable statutes and regulations;
(3) limit the authority of the Secretary of Health and
Human Services under--
(A) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
et seq.) as in effect on the day before the date of enactment
of this Act; or
(B) the Public Health Service Act (42 U.S.C. 301 et seq.)
as in effect on the day before the date of enactment of this
Act;
(4) alter or limit the authority of the Secretary of
Agriculture under the laws administered by such Secretary,
including--
(A) the Federal Meat Inspection Act (21 U.S.C. 601 et
seq.);
(B) the Poultry Products Inspection Act (21 U.S.C. 451 et
seq.);
(C) the Egg Products Inspection Act (21 U.S.C. 1031 et
seq.);
(D) the United States Grain Standards Act (7 U.S.C. 71 et
seq.);
(E) the Packers and Stockyards Act, 1921 (7 U.S.C. 181 et
seq.);
(F) the United States Warehouse Act (7 U.S.C. 241 et seq.);
(G) the Agricultural Marketing Act of 1946 (7 U.S.C. 1621
et seq.); and
(H) the Agricultural Adjustment Act (7 U.S.C. 601 et seq.),
reenacted with the amendments made by the Agricultural
Marketing Agreement Act of 1937; or
(5) alter, impede, or affect the authority of the Secretary
of Homeland Security under the Homeland Security Act of 2002
(6 U.S.C. 101 et seq.) or any other statute, including any
authority related to securing the borders of the United
States, managing ports of entry, or agricultural import and
entry inspection activities.
SEC. 404. COMPLIANCE WITH INTERNATIONAL AGREEMENTS.
Nothing in this Act (or an amendment made by this Act)
shall be construed in a manner inconsistent with the
agreement establishing the World Trade Organization or any
other treaty or international agreement to which the United
States is a party.
SEC. 405. DETERMINATION OF BUDGETARY EFFECTS.
The budgetary effects of this Act, for the purpose of
complying with the Statutory Pay-As-You-Go-Act of 2010, shall
be determined by reference to the latest statement titled
``Budgetary Effects of PAYGO Legislation'' for this Act,
submitted for printing in the Congressional Record by the
Chairman of the Senate Budget Committee, provided that such
statement has been submitted prior to the vote on passage.
Amend the title so as to read: ``An Act to amend the
Federal Food, Drug, and Cosmetic Act with respect to the
safety of the food supply.''.
Motion to Concur
The SPEAKER pro tempore. The Clerk will report the motion.
The Clerk read as follows:
Mr. Dingell moves that the House concur in the Senate
amendments to H.R. 2751.
The SPEAKER pro tempore. Pursuant to House Resolution 1781, the
motion shall be debatable for 1 hour equally divided and controlled by
the chair and the ranking minority member of the Committee on Energy
and Commerce.
The gentleman from Michigan (Mr. Dingell) and the gentleman from
Pennsylvania (Mr. Pitts) each will control 30 minutes.
The Chair recognizes the gentleman from Michigan.
General Leave
Mr. DINGELL. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and to insert extraneous matter into the Record.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Michigan?
There was no objection.
Mr. DINGELL. Mr. Speaker, I now yield 4 minutes to the gentleman from
California (Mr. Waxman), the distinguished chairman of the Committee on
Energy and Commerce.
Mr. WAXMAN. Mr. Speaker, I appreciate the gentleman from Michigan
(Mr. Dingell) yielding to me. And I want to commend you, Representative
DeLauro, Congressmen Pallone and Stupak, Mr. Barton and Mr. Shimkus,
and former Representative Deal for the work on this legislation.
[[Page H8885]]
For a third time, today the House considers legislation that will
dramatically improve the safety of our Nation's food supply. The House
first passed its bill in July 2009 on a strong bipartisan vote with 283
supporters. On November 30 of this year, the Senate passed the FDA Food
Safety Modernization Act on a strong bipartisan basis, by a vote of 73-
25. That bill contained some constitutional defects that needed to be
fixed. So on Sunday night, the Senate again passed a corrected version
of the bill by voice vote.
Congress has demonstrated that food safety is a bipartisan issue.
Food-borne illness outbreaks can strike each and every one of us. In
recent years, foods we never would have imagined to be unsafe,
everything from spinach to peanut butter, have sickened an untold
number of Americans. It is time, once and for all, to enact this
legislation. There is no time for any further delay.
FDA needs a modern set of authorities to deal with the effects of our
increasingly globalized food supply. This legislation will give FDA the
tools and resources it needs to better police the safety of the foods
we eat every day. The bill makes significant improvements throughout
the food chain, from the farm to the dinner table. The bill will
require farmers to comply with science-based standards for safe
production and harvesting. Companies that process or package foods will
be required to implement preventive systems to stop outbreaks before
they occur. Importers will have to demonstrate that the food they bring
into the country is safe. And the bill strengthens FDA enforcement
authorities, giving FDA the ability to order a food recall when
companies refuse to voluntarily do so.
Many of us in the House would agree that our bill was stronger. We
also would likely agree that it is regrettable that there was not time
for a conference to allow us to make some improvements in the Senate
bill. But this is an opportunity that will not come again for a long
time. There is no question that this is a good bill and that it will
provide FDA with some critical new authorities. It will fundamentally
shift our food safety oversight system to one that is preventive in
nature as opposed to reactive. We simply must take this chance to make
our food supply safer. I urge my colleagues to vote ``yes'' on H.R.
2751.
Mr. PITTS. Mr. Speaker, I yield myself such time as I may consume.
At the Energy and Commerce Committee, food safety has been a
bipartisan priority. We have held numerous hearings during the last two
Congresses, examining food safety problems involving peppers and peanut
butter and what we can do to solve those problems. During those
hearings, we have heard about how much work our Nation's farmers,
manufacturers, and distributors do to put low-cost, high-quality food
on the tables of more than 300 million people every day. We also have
heard about how much our Nation's children and our Nation's farmers and
small businesses can be hurt when one irresponsible actor sells
adulterated, contaminated food.
Thanks to helpful testimony from hearing witnesses and hard work by
our committee members, we were able to come up with some good ideas to
help solve those food safety problems. Those ideas were found in the
Food Safety Enhancement Act, which passed the House in July of 2009 and
represented the bipartisan work of Chairman Waxman, Chairman Emeritus
Dingell, Chairman Pallone, Chairman Stupak, Governor-Elect Deal, and
Ranking Member Shimkus.
The Food Safety Enhancement Act passed more than 16 months ago. The
Senate finally passed its food safety bill, the Food Safety
Modernization Act, Senate 510, during the lame duck session. The
provisions of Senate 510 are contained in the bill that we are
considering today with no substantive changes from what passed the
Senate 3 weeks ago.
I intend to vote against this bill because it represents such a gross
departure from reasonable legislating. When the Senate passed its food
safety bill 3 weeks ago, we asked our majority to take the bill to
conference. Instead, we were forced to vote on the Senate bill with no
substantive changes as part of the continuing resolution 2 weeks ago.
During the 111th Congress, we have learned a great deal about how not
to do things, and this bill presents us with another example. Instead
of just taking up the Senate bill, we should have held a conference.
We've been told we couldn't do that because there wasn't enough time.
Well, instead of naming post offices, we should have rolled up our
sleeves and gotten to work on negotiating. And now, 3 weeks and many
post offices later, the majority says we have to take it or leave it.
{time} 1530
One provision that raises questions is the so-called Tester amendment
that was added to the Senate food safety bill. This provision will
provide exemptions from food safety requirements based on a facility's
or a farm's size. While we do not want to overly burden small
facilities and small farms, we've learned in our committee hearings
that food-borne pathogens don't care if you're a big facility or a
small facility, a big farm or a small farm. They affect everyone.
A food safety issue in one facility or one farm can cause hundreds of
illnesses and hundreds of millions of dollars in economic losses for
farmers and small businesses. By allowing facilities exemptions from
food safety requirements, we're setting our Nation up for the potential
of future outbreaks. Our system is only as strong as its weakest link,
and the Tester amendment will set up a system full of weak links.
This is just one example of the potential problems with this bill.
These are problems we could have addressed through a conference, but,
instead, we wasted 3 weeks and are being told, take it or leave it.
I urge my colleagues to vote ``no'' on this legislation so we can do
it the right way in the next Congress.
I reserve the balance of my time.
Mr. DINGELL. Mr. Speaker, I yield 4 minutes to the distinguished
gentleman from New Jersey (Mr. Pallone).
Mr. PALLONE. Chairman Dingell, I want to thank you for all the hard
work you have put in on this bill, and also Chairman Waxman. We worked
on a bipartisan basis.
I rise today in strong support of the Food Safety Modernization Act.
After 2 years of hard work, we're finally on the cusp of enacting
landmark comprehensive food safety legislation.
The modernization of our food safety system is desperately needed.
The current food regulatory regime was established in 1938 and hasn't
been overhauled in 70 years. Since this time, the U.S. food supply has
evolved into a global network made up of foreign products, processors,
and growers over whom the U.S. has little or no control. Think about
what a different world it was in 1938. That alone should be reason
enough to update our food safety laws today.
Every time we have a food safety crisis, be it eggs or spinach or
peppers or peanuts, we shake our heads at the vulnerability of our food
supply and bemoan the fact that we don't have the tools to protect it.
And these aren't isolated instances. Each year, 48 million Americans
are sickened from consuming contaminated food, and as many as 3,000 to
5,000 of these people die.
The Food Safety Modernization Act will give the FDA the ability, the
authority, and the resources to protect American consumers from
contaminated food domestically and abroad. FDA will now better ensure
food safety through more frequent inspections of food processing
facilities, the development of a food trace-back system to pinpoint the
source of food-borne illnesses, and enhanced powers to ensure that
imported foods are safe. Perhaps most notably, the bill emphasizes
prevention and safety that helps ensure that food is safe before it's
distributed, before it reaches store shelves, before it reaches the
kitchens of American families.
We have the most productive and most efficient food distribution
system in the world, but we need to make sure that we have the safest
food supply. American families need to know the food they select from
grocery stores and the meals they put on their kitchen tables are safe.
Now, I'll say the bill before us isn't perfect, but it is a good
bill, and it's backed by a diverse coalition that includes food
producers, grocery manufacturers, and consumers. It has strong
bipartisan support. Last year, the
[[Page H8886]]
House passed its version by a vote of 283-142. The Senate passed a bill
nearly identical to the one before us today by a vote of 73-25. And
this is an overwhelming show of support for legislation which will
significantly protect the public health.
I'm proud we're passing this bill one more time. Today, of course, it
will go to the President for his signature. He has said he would sign
it. And I urge my colleagues to support this landmark legislation.
Mr. PITTS. Mr. Speaker, I yield 4 minutes to the ranking member on
Agriculture, Representative Lucas from Oklahoma.
(Mr. LUCAS asked and was given permission to revise and extend his
remarks.)
Mr. LUCAS. Mr. Speaker, I rise again in opposition to H.R. 2751,
originally dealing with the Cash for Clunkers and now containing the
Senate language S. 510, the Food Safety and Modernization Act.
As I've stated repeatedly, I believe our Nation has the safest food
supply in the world. I also believe that we must continually examine
our food production and regulatory system and move forward with changes
that will improve food safety.
This legislation is the product of a flawed process. It will lead to
huge regulatory burdens on our Nation's farmers and ranchers. It will
raise the cost of food for our consumers, and it contains very little
that will actually contribute to the goal of food safety. It gives the
Food and Drug Administration lots of additional authorities with no
accountability. In fact, with the inclusion of the so-called Tester
amendment, some argue that it is a step backwards.
Now, my concerns about the legislation are not limited to the
unforgivable process. There are serious public policy concerns as well.
The Tester amendment is an illustrative example. Intended to shield
small and local producers from the burdens of the new food safety law,
it is opposed by virtually all of the major organizations representing
farmers and ranchers. Normally, these groups would be expected to
support a provision that sought to protect their farmers and ranchers.
But they oppose the Tester amendment and any legislation that contains
it because it adds to the layers of food safety regulation by creating
yet another tier of regulatory standards that will only confuse our
consumers.
Further, by exempting small domestic companies from Federal
standards, I fear, and this is a legitimate fear, that we will be
required to exempt similarly sized companies in developing countries
from our standards. This approach does not make food safer. It
eliminates important consumer protection and puts our citizens at
increased risk.
With respect to the Tester amendment, I question the value of any law
that is so onerous to an industry that Senators believe segments of
that industry should be excluded from it. It would be wise to
reconsider the entire legislative approach.
Now, there are other problems as well in the bill. New regulation
authority for food processing facilities will create what amounts to a
Federal license to be in the food business. Registration of food
processing facilities was originally envisioned as a commonsense way to
help FDA identify facilities under the Bioterrorism Act of 2002. This
bill turns it into a license to operate, making it unlawful to sell
food without a registration license, and allowing FDA to suspend the
company's registration. This is the type of government intrusion into
commerce that Americans rejected in early November of this year.
Another provision of particular concern would mandate the Food and
Drug Administration to set on-farm production performance standards.
For the first time, we'd have the Federal Government prescribing how
our farmers grow crops. Farming, the growing of crops and the raising
of livestock, is the first organized activity pursued by man. We've
been doing it for a long time, and we've been doing it without the FDA
on the farm.
The vast majority of these provisions, along with the recordkeeping
requirements, traceability, mandatory recall authority, will do
absolutely nothing to prevent food-borne disease outbreaks from
occurring but will do plenty, do plenty, to keep Federal bureaucrats
busy. And these are all the sorts of things that could be worked out
through the normal legislative process, but only if there's a process.
Mr. Speaker, let me return to where I started. We have the safest
food supply in the world. Anyone who follows current events knows that
our food production system faces ongoing food safety challenges, and I
stand ready to work with my colleagues, all of my colleagues, to
address those challenges.
Our Nation's farmers, ranchers, packers, processors, retailers, and
consumers deserve better.
Mr. DINGELL. Mr. Speaker, I yield 3 minutes to the distinguished
gentleman from Michigan (Mr. Stupak), who has been the chairman of our
Oversight and Investigation Subcommittee, who's done the wonderful
investigative work that has brought us to where we are in exposing the
dangers to our food supply by imports and other things, with my
commendations and good wishes.
{time} 1540
Mr. STUPAK. I thank the gentleman for yielding and for the kind
words. As I wrap up my 18 years in the U.S. House of Representatives,
this is a good bill in which to wrap up a career. I first introduced
food safety legislation along with Mr. Dingell and Mr. Pallone and now-
Senator Brownback in 1997. For 14 years we have been fighting to try to
update our Nation's food safety laws.
And then as chair of Oversight and Investigations, we have held over
13 hearings on food-borne illnesses from spinach, peanut butter,
jalapenos, and most recently tainted eggs. Why was all this necessary?
As has been noted, our food laws have not been updated since 1938. And
we know more and more of our foods are coming from different sources
and different countries. But this year and each year approximately 77
million Americans become ill because of food-borne illnesses, 325,000
are hospitalized, and up to 5,000 Americans will die, some of our most
vulnerable Americans, such as children and senior citizens, those whose
immune systems have been weakened or are not fully developed.
But if you are a young child and you do survive, what kind of life do
you have after you have spent time in a hospital getting a new kidney?
You face a lifetime of medication and bankruptcy of your family. We
must act now to pass this food safety bill. This bill contains many
good provisions, including the trace-back provision, which is designed
to make it easier to prevent and respond to outbreaks in food-borne
illnesses.
This also has mandatory recall. Most Americans are shocked to know
that the FDA does not have the right to recall food or unsafe drugs in
this country. They do not have the right to have that recall,
especially on food. So this will now make it mandatory. The FDA can
remove tainted food as soon as possible. Still, despite all these
improvements, more has to be done to protect Americans.
The FDA needs subpoena power. It is probably one of the few
regulatory agencies that doesn't have subpoena power. We lost that when
it went to the Senate. But if you are going to trace back, if you are
going to get the records, if you are going to find where the food comes
from, let's give the regulatory agency the power they need. Because
corporate America unfortunately too often hides their records from us.
We need an adequate funding source. For this legislation to be
successful, we have to have an adequate funding source, as we had in
the House but was removed in the Senate. And country of origin label.
More and more of our food, especially this time of the year in the
winter months, comes from other countries. We need to know exactly
where those sources of food come from. So I urge the next Congress to
make these improvements.
And a word of caution. Without this bill and greater improvements to
this bill, we cannot fully protect Americans from food-borne illnesses,
either accidentally or those intentionally put forth by America's
enemies. And make no mistake about it, our enemies will exploit our
weak regulatory system when they know they can harm so many Americans
through food-borne illnesses.
So I hope my colleagues today will join me in supporting this
legislation.
[[Page H8887]]
It's a great piece of legislation. I would like to thank my colleagues
who have worked so hard on this over the years with me, including Ms.
DeLauro of Connecticut, but especially the members of the Energy and
Commerce Committee who have worked with us, especially Chairman
Dingell, Chairman Waxman, Mr. Pallone, Mr. Upton, and Mr. Barton.
Mr. PITTS. Mr. Speaker, I reserve the balance of my time.
Mr. DINGELL. Mr. Speaker, I yield 5 minutes to the distinguished
gentlewoman from Connecticut (Ms. DeLauro), the chairman of the
Agriculture Appropriations Subcommittee, and very much interested in
the matter before us. She has worked on it a long time.
Ms. DeLAURO. Mr. Speaker, I rise today in support of this bill as a
good and a necessary first step in reforming our food safety system and
better protecting our families from food-borne illness. And I want to
congratulate some of the longtime champions of food safety in this
institution, such as Chairman Henry Waxman, Chairman John Dingell,
Subcommittee Chairman Frank Pallone, Mr. Bart Stupak. And I say
congratulations to them for successfully bringing this legislation
through the House. I also want to acknowledge Senator Harkin and
Senator Durbin for their work in facilitating passage of this bill in
the Senate.
Among the critical reforms in this bill are increased inspection of
high-risk facilities, expanded authority to inspect recall records, the
formation of a more accurate food facility registry, improved
traceability in the event of an illness outbreak, and improved
surveillance of food-borne illness. The bill also requires
certification of certain foreign food imports as meeting U.S. food
safety requirements.
All of these tools will help improve the FDA's ability to respond to
food-borne illness outbreaks and to hold industrial food production
facilities to higher standards. For too long the cornerstone of our
food safety system, the FDA, has had only ancient tools and an outdated
mandate at its disposal. This bill will go a long way towards stemming
the potential of a full-blown food-borne epidemic in the future.
Recently, the CDC released an updated estimate on food-borne illness
figures, and it remains a major public interest health threat. With
nearly 50 million illnesses, 100,000 hospitalizations, and over 3,000
deaths each year, these estimates show that there is much work to be
done in identifying and combating the pathogens that cause food-borne
illness.
Just to tell you the importance of this bill, let me share with you
the story of Haylee Berstein, a 17-year old girl who lives in Wilton,
Connecticut. When Haylee was 3 years old, she ate unwashed lettuce that
was contaminated with E. coli. She soon became extremely ill with what
doctors called hemolytic uretic syndrome. The health effects of an E.
coli illness are very painful. Haylee experienced traumatic damage to
her kidneys and pancreas. She suffered severe bleeding in her brain.
And that blood in her brain caused her to be temporarily blind. The
doctors at Yale-New Haven Children's Hospital fought for 14 weeks to
save her life. And to this day, Haylee still suffers from health
problems such as diabetes, all because of food contaminated with E.
coli. This should not happen to anyone. And as we know in this body, it
can be prevented.
With all of this in mind, our food safety efforts should not, and
will not, end today. Because this piece of legislation is not about
roads and bridges and parks and other things that we do in this
institution. This legislation is about life and death. While the FDA is
charged with protecting a large majority of our food supply, the Food
Safety and Inspection Service, FSIS at USDA, is responsible for
ensuring the safety of meat and poultry products. After passing this
bill today, we must begin to lay the foundation for science-based
reform at FSIS as well. That is why I worked on language that would
create a science-based panel, supported by a wide range of
stakeholders, to analyze the food safety system at FSIS and develop the
concept of what a modernized system would look like there.
This collaborative proposal is supported by the pertinent industries,
consumer groups, and unions. I should emphasize that this plan would
not interfere with the good work currently being done by Under
Secretary Elisabeth Hagen at FSIS. And I look forward to working with
all of my colleagues in the next Congress to move this proposal
forward.
Ultimately, I believe, as do leaders across the aisle, that we must
establish a single food safety agency. Currently, food safety
responsibilities are fragmented across 15 Federal agencies and are
governed by 71 interagency agreements. Food safety and public health
experts, as well as the Government Accountability Office, have
concluded that this fragmentation has created redundancies that have
weakened our food safety response. We need to consolidate all of these
food safety functions under one roof. This will provide an updated
regulatory structure and strengthen oversight and surveillance
activities to better protect our food supply.
I will continue to fight for this single agency. I believe it is
needed to ensure that the food in our fridges and on our kitchen tables
is safe. Nonetheless, the legislation we must pass today is a strong
first step toward a safer food supply and reducing the number of
preventable food-borne illnesses and deaths. I urge my colleagues to
face this public health threat and to pass food safety legislation.
Every parent who goes in to buy food needs to know that they are taking
it home and it's safe for their children.
Mr. PITTS. I continue to reserve the balance of my time.
Mr. DINGELL. Mr. Speaker, I yield 2 minutes again to my good friend,
the chairman of the Committee on Energy and Commerce, Mr. Waxman, for
purposes of correcting the record on certain erroneous statements made.
Mr. WAXMAN. Mr. Speaker and my colleagues, the Senate only passed
this bill a couple of nights ago. And so we have now the opportunity to
vote to take it or reject it. Some on the other side of the aisle,
Republicans, are saying we should reject the whole bill because of the
Tester amendment, which exempts small farmer-producers and facilities.
We didn't have that in our bill, and I would have preferred that the
Senate had not adopted that provision. But I don't think it is a reason
to vote against this whole bill.
This bill is a good bill. It is supported by the Consumer Federation
of America, the Consumers Union, the National Consumers League, the
Trust for America's Health, the American Public Health Association. And
it's supported by major industry groups, the Food Marketing Institute,
the Grocery Manufacturers Association, and the U.S. Chamber of
Commerce.
Now, I would assume that some big operations don't like the fact that
small ones are going to be exempt. They are only exempt from a couple
of the provisions which Senator Tester and the Senate Members thought
were too burdensome. And some of these small operations are limited in
their income, and therefore it might be too burdensome for them.
{time} 1550
Republicans have suggested we should have gone to conference. If we
had gone to conference, only one Senator could object and no conferees
would be appointed by the Senate. So that burden we are being asked to
have achieved is something we could not achieve in the short time
available to us.
Let us not let this opportunity go by. We must adopt this
legislation. If there are efforts to change it later on, fine. But this
is an important bill that has been worked on for years. It had strong
bipartisan support in the House. It had overwhelming bipartisan support
in the Senate. And I want to clarify the record to point out that
almost all the groups, the consumer groups and the industry groups, are
urging an ``aye'' vote.
Mr. PITTS. I continue to reserve the balance of my time.
Mr. DINGELL. Mr. Speaker, I have only one further speaker on this
side, so I suggest to my good friend from Pennsylvania, if he desires
to speak, he should speak forthwith.
Mr. PITTS. I have no further requests for time, and I yield back the
balance of my time.
Mr. DINGELL. The gentleman is a complete gentleman. I don't want to
deny him any opportunity to be heard. I want to thank the gentleman. He
is always courteous. I express my gratitude to him for the way he
behaves.
[[Page H8888]]
I yield myself 5 minutes, Mr. Speaker.
Mr. Speaker, this is not the first time we have seen this bill. It
came out of the Committee on Energy and Commerce unanimously. It was
informally referred to the Committee on Agriculture, where they had a
chance to take a look at it. It passed the House overwhelmingly on two
occasions in a slightly different form. It then came back here and it
was passed yet another time with the changes virtually to make it
identical to that form in which it is. Those changes have been removed
in some regards because they were mostly simply technical changes. So
it has passed this body three times before this. This is the fourth
time we have considered it. The Senate has passed it twice. On Sunday
night, they passed it under a unanimous consent procedure.
The bill has enormous support, and all of the consumer organizations
support it. Almost every business group in the field of food
manufacturing and processing supports it: The Grocery Manufacturers
Association, the National Association of Manufacturers, the Chamber of
Commerce, the Consumer Federation of America, the American Public
Health Association, the Bakers Association, the Beverage Association,
the American Public Health Association, Pew Charitable Trust, the U.S.
PIRG, and also the Food Marketing Institute as well as the Center for
Science in the Public Interest. There is literally little, if any,
opposition to the consideration of this legislation.
The Senate took from last summer when the House passed the bill until
just a few weeks ago to pass the bill over there. It only passed for
the final time on Sunday night. I want to agree with my good friend
from Pennsylvania; the House's skill as a legislative body is far
superior to that of the other body, and if they would leave the
legislation alone, I think I could assure the House that we would pass
better legislation than they do over there.
But having said these things, we are about now to be forced at the
last minutes of this session to choose between not passing a superb
bill and passing no bill at all because we want to achieve a greater
level of perfection.
This is the first significant change in food and drug law with regard
to foods since 1938. At that time, you could test foods down to a few
parts per thousand. Today, you can do it down to parts per billion and
parts per trillion, and food is being affected by huge numbers of new,
incredibly complex known and unknown molecules that are inserted.
The bill before us serves a basic and necessary and admirable
purpose. It is going to have the purpose of seeing to it that the
American consumer can again have confidence in the safety of their food
supply.
Our manufacturers, our growers, and our processors do the best job in
the world. The problem is we now import something like about one-
quarter to one-third of our food supplies, and those food supplies are
coming from places like China. And we have had some scandals of the
most appalling character with regard to both domestic and imported
food, but mostly with regard to imported food: bad seafood and
shellfish from China, unsafe leafy vegetables like spinach and celery
from China, bad berries and fruit from Chile and other places like
that, peppers from Mexico that got mixed in with salsa and caused the
collapse of the American tomato industry.
These are things that will be corrected by us having people available
in Food and Drug to properly investigate, to properly correct and
properly see to it that these unsafe foods don't get into our food
chain, with the consequences not only that they poison Americans, but,
worse, that they destroy American industry and cost us the faith of the
American consuming public for some of the best manufacturers and
processors in the world. The Chinese put melamine in milk. They sent us
all manner of dangerous and unsafe food.
Now we are giving the agency, Food and Drug, the authority it needs.
This does not invade the jurisdiction of the Agriculture Committee. It
was very carefully kept to see to it that it stayed within the
jurisdiction of the Commerce Committee.
The SPEAKER pro tempore. The time of the gentleman from Michigan has
expired.
Mr. DINGELL. I yield myself 2 additional minutes.
It creates a new focus on prevention, and it shares responsibility
between FDA and the food manufacturers so that they can cooperatively
work to keep the food supply safe, working together.
It also is going to require manufacturers to implement preventive
systems to stop outbreaks before they occur, and it is going to allow
our Food and Drug Administration, for the first time in history, to
police and to protect the entry into this country of foods coming from
abroad, where most of the peril to our American consumers lie.
It also is going to allow our investigators and Food and Drug people
to see to it, and this is a word of art, that the American law with
regard to good manufacturing practices is carried forward in those
other lands so that bad food cannot originate elsewhere and then come
in to the United States because of shoddy manufacturing practices.
It gives Food and Drug power to ensure that foreign importers meet
U.S. standards, and it will assure that foreign growers and producers
will be treated with the same care and attention that American growers
and producers are so our growers and producers can know that they are
facing an even and level playing field. It gives FDA new enforcement
tools, mandatory recall authority, authority to detain tainted
products, and protections for employees who serve as whistleblowers.
This legislation is long overdue. It will address a situation which
is shameful.
Today, according to the latest statistics, 48 million Americans are
sickened by bad food, some 128,000 are hospitalized, and 3,000 are
killed yearly. We can dawdle around and let the House and the Senate
wait until next year to perhaps pass a different bill. Whether it will
be better or not is open to question.
The SPEAKER pro tempore. The time of the gentleman has again expired.
Mr. DINGELL. I yield myself 1 additional minute.
Whether it will be better is open to question. But I will tell my
colleagues, during that time there are going to be Americans sickened,
there are going to be Americans killed, and there are going to be
Americans hospitalized. American manufacturers and processors and
growers are going to have the quality of their food products impinged,
not by their carelessness or bad behavior but, rather, by the
misbehavior of foreign producers, foreign manufacturers, and others who
are sending things in here like milk products with melamine. Melamine
is a constituent, believe it or not, of Formica.
{time} 1600
It kills people. It kills babies. And China sells these products to
their own people. If they will kill their own people with that kind of
trash, imagine the glee with which they will sell that kind of trash
over here to threaten the well-being and the safety and the trust of
American consumers, businessmen, manufacturers, producers, and growers.
I beg you, the safety of your constituents, of our people, is at
stake. And I hope you will work with me to pass this legislation so
that we can make our consumers not only trust the system but also to
know that it is going to work to protect them.
The SPEAKER pro tempore. The time of the gentleman has again expired.
Mr. DINGELL. I yield myself 1 additional minute.
I hope if there's enthusiasm for doing further work on this, that my
colleagues will join me next year in doing the same thing with regard
to pharmaceuticals. And I remind you that the committee has worked not
in opposition to American industry, but rather the committee has worked
with American industry, which supports the legislation.
Would it be better if we were passing the House bill? Absolutely. Is
it worse and weaker because we're passing the Senate bill? Of course.
But having said that, you're making Americans safe in spite of the fact
that the U.S. Senate has to take a ride with this legislation
[[Page H8889]]
to, quite frankly, the weakening of this legislation.
I want to commend my colleagues who have participated: Mr. Waxman,
Mr. Pallone, Mr. Stupak, Ms. DeGette, and Ms. DeLauro. And I want to
commend the staff: Katie Campbell, whose last day this is; Virgil
Miller; Rachael Sher; Eric Flamm; and Emily Gibbons, who have made this
possible. Our legislative counsel has labored vitally on it, and we owe
real thanks to Warren Burke and Megan Renfrew.
I want to commend my Republican colleagues. I know that they're not
supporting this legislation, and I grieve about that. But the harsh
fact of the matter is they were very helpful in doing this in times
past. And I want to pay particular tribute to Mr. Shimkus, Mr. Deal,
and Mr. Barton, but I do want it known that were it not for the labor
of three great men in the other body, we would not be where we are.
Senator Harkin, Senator Durbin, and Senator Reid have contributed
vitally to the success which we've had in making the American consuming
public safe. And I hope that the people will understand we have served
them well.
I urge my colleagues to vote for this bill, secure in the knowledge
that you're protecting Americans and you're saving the lives and the
health and the well-being of the American people by passing H.R. 2751.
I rise today in strong support of the FDA Food Safety Modernization
Act and I urge my colleagues to vote in favor of this legislation with
deliberate speed.
Mr. Speaker, consideration of this bill today is what I hope will be
the final step of a long legislative journey. My colleagues in this
body passed similar legislation last July. Some 17 months later, we are
working on the same issue.
The legislative fits and starts is in no way a reflection of the
policy, however, the legislation has been the hostage of political
games and procedural missteps. The FDA Food Safety Modernization Act
serves a necessary and admirable purpose--it will go a long way in
boosting American consumer confidence in the safety of the nation's
food supply. The many recalls that have confronted American consumers
over the years--peanuts, melamine in milk, eggs, bad seafood and
shellfish, unsafe leafy vegetables like spinach, bad berries and
peppers--has called into question the ability of the government to
adequately protect American consumers. The FDA Food Safety
Modernization Act addresses this concern head on and grants the Food
and Drug Administration--the Agency with oversight of 80 percent of the
nation's food supply--the authorities and resources it needs to
effectively do its job.
Among other things, the legislation will:
Create a new focus on prevention, and a shared responsibility between
FDA and food manufacturers to keep the food supply safe. It will
require manufacturers to implement preventive systems to stop outbreaks
before they occur;
Require FDA to inspect food facilities--foreign and domestic--more
frequently;
Grant FDA new authority to ensure that imported foods meet U.S.
safety standards and will assure foreign growers and producers must be
treated with the same care that American growers and producers are; and
Grant FDA new enforcement tools, including mandatory recall
authority, authority to detain tainted products, and protection for
employees who uncover food safety violations.
Mr. Speaker, enactment of this legislation is long overdue and
necessary--necessary for the millions of Americans who suffer from
foodborne illness each year, and the thousands who die from it each
year.
We will bring to a halt a shameful situation where 48 million
Americans are sickened by bad food, 128,000--yes 128,000 Americans--
hospitalized and 3,000 people killed by bad food.
I strongly support the legislation before us today and urge my
colleagues to cast an aye vote.
S. 510 Supporters
Obama Administration--FDA
American Bakers Association; American Beverage Association;
American Public Health Association; Center for Foodborne
Illness, Research & Prevention; Center for the Science In The
Public Interest; Consumer Federation ot America; Consumers
Union; Flavor and Extract Manufacturers Association; Food
Marketing Institute; Grocery Manufacturers Association;
Institute of Shortening & Edible Oils Inc.; International
Dairy Foods Association; International Bottled Water
Association; National Association of Manufacturers; National
Coffee Association of U.S.A., Inc.; National Confectioners
Association; National Consumers League; National Restaurant
Association; The Pew Charitable Trusts; Snack Food
Association; STOP--Safe Tables Our Priority; Trust For
America's Health; U.S. Chamber of Commerce; and U.S. PIRG:
Federation of State PIRGs.
Ms. JACKSON LEE of Texas. Mr. Speaker, I rise today in strong support
of the FDA Food Safety Modernization Act.
H.R. 2751, the FDA Food Safety Modernization Act would help expand
the FDA authority to inspect records relating to food while increasing
inspections on high-risk on food facilities. Through passage of this
bill, a more accurate registry of all food facilities serving American
consumers would exist. It is important to provide safe and clean food
for the American people, who deserve nothing but the best.
The safety and sanitation of food produced and distributed throughout
the United States is of utmost importance. The health and well being of
every person in this country hinges on the quality and effectiveness of
the food inspection process. Without proper inspection, there is a
possibility of contamination of foods and the spread of disease.
In the spring of 2008, a case of salmonella spread throughout the
country as a result of a single tainted pepper from a South Texas
produce warehouse. This strain of salmonella sickened 1,251 people, led
to the hospitalization of 229 people, and sadly, two deaths. Once the
origin of the salmonella outbreak was determined, the FDA and other
federal agencies took action and required the responsible parties to
recall all produce that they thought may have been tainted.
In the United States in 2010, at a time when we have the newest and
greatest technologies at our disposal, outbreaks like the one mentioned
should not take place. With improved and modernized safety inspections,
such outbreaks can be avoided and prevented.
It is because of stories like this that I am ever so moved to ensure
that H.R. 2751, the FDA Food Safety Modernization Act is passed in the
House of Representatives and that it eventually becomes law.
Passage of the FDA Food Safety Modernization Act will prevent such
salmonella scares from happening again in the future--in Texas or in
any state in the country--for that matter.
This bill would also allow for improved traceability of the history
of food in the event of a food borne illness outbreak. Often time, when
our country has been faced by serious food poisoning that have affected
thousands of American people, we do not know where the food was
produced or cultivated. This bill would bring an end to that. It is
important for us to be ever cautious that could affect the well being
and health of our children, elderly and family members.
In addition to what I have mentioned, this bill would also make
available a certificate of certain food imports--requiring all foods
imported into the United States to meet all U.S. food safety
requirements. The certificate would ensure that we are only allowing
the safest and most healthy food into our country for consumption by
the American people.
Another important component of this legislation would ensure
protection of whistleblowers that bring attention to important safety
information pertaining to the food regulation and food safety. It is
most vital that we afford those people who may know information about
certain food the opportunity to inform authorities about any concerns
they may have with their consumption.
The bill contains important provisions that address the industry
concerns, which include the elimination of the registration fee imposed
on facilities participating in the food system. In addition, this
legislation provides for a limited exemption for small food producers
and processors that sell the majority of their food directly to
consumers or to grocers within a circumscribed area and whose food
sales are less than $500,000 per year.
The legislation before the House of Representatives is supported by a
range of consumer and industry groups, including the American Public
Health Association, the Center for Foodborne Illness Research and
Prevention, the Center for Public Interest, the Consumer Federation of
America, the Grocery Manufacturers Association, and the U.S. Chamber of
Commerce.
It is time that we stand with this broad-based coalitions as we work
to improve the food we eat and consume and know where exactly it's
coming from. These actions will only help our country, families and our
American people from having safety and consumer-friendly produce, meats
and dairy.
Mr. FARR. Mr. Speaker, I would first like to thank Chairman Waxman
and Chairman Dingell for drafting a very strong food safety bill and
leading a comprehensive debate by the House. Their legislation included
three vital components that are all founded on a strong scientific
base. I also want to commend them for including the teeth we need to
implement mandatory recalls, as well as a commodity-specific approach
to produce safety. Also important, the bill incorporated the
flexibility we need to cover our growers, handlers, and processors.
Yet the Senate bill we will be voting on today, The FDA Food Safety
Modernization
[[Page H8890]]
Act, fails to meet that high bar set by the original House bill.
Because the version that is now before us has abandoned its original
scientific base, I must sadly oppose this legislation.
Let me be clear: I understand the need for food safety reform all too
well. The safety of America's supply of fresh fruits, vegetables and
nuts will always be my highest priority. I know firsthand the impact an
outbreak can have on an industry, and for that reason, understand the
strong need for far reaching regulations based on the best science
available.
The Center for Disease Control estimates, released December 15th,
state that 48 million people in America--that's 1 in every 6--get sick
every year from contaminated food. Furthermore, 128,000 are
hospitalized and 3,000 die being exposed to this contaminated food.
These are staggering numbers considering the United States still has
the safest food supply in the world.
I also know each time any fruit or vegetable is implicated in an
outbreak of food borne illness, the industry as a whole suffers from
devastating loses in consumer confidence. In the long run, this is
simply not sustainable, and it's certainly not acceptable for growers
or consumers.
At the very least, our nation needs a minimum food safety standard
that applies to every producer. And we need to help all growers small
or large, comply with the regulations that will be promulgated from
this legislation. Anything less falls short of true food safety reform,
and could be a dangerous disservice to the American public.
The region I represent, California's Central Coast, is the top
producing specialty crop region in the world. As such, I am proud to
say that food safety is our region's industry's top priority. The men
and women who grow, pack, and market fresh produce are committed to
providing consumers with safe and wholesome foods from field to fork.
Our local industry is constantly working to enhance and improve their
performance in growing crops, harvesting and handling for distribution,
packaging and processing into convenient ready-to-eat products. In
addition to following all protocols to maintain the safest possible
delivery chain--all the way to the consumer's table.
Mr. Speaker, Food Safety knows no price point--Salmonella, e. Coli
and Listeria don't care if the food is grown conventionally or
organically--or if the produce is grown on a large ranch or small farm.
That's why provisions in this bill that exempt small producers from
oversight are simply unacceptable and dangerous. We need policy based
on sound science, and exempting certain sectors of the industry is not
sound policy. Instead, we should be providing those small producers
with the tools and incentives they need to meet the food safety
standards we are voting on today.
Food producers are dedicated to continuously improving on-farm food
safety practices--inclusion of exemptions from food safety laws is a
huge step backward, and will send the wrong message to the food
industry. Even worse, it will send the wrong message to the American
consumer.
Congress needs to understand--just as my growers understand--that any
fruit or vegetable implicated in an outbreak taints the entire
agricultural industry. And those isolated instances are cumulative. If
we allow small producers to avoid oversight, the outbreaks that are
likely to occur will result in the harm of all growers, handlers,
processors, and shippers.
I'm committed to ensuring that when food safety regulation does come
to fruition, it is developed and implemented with industry input. And
that it provides pragmatic food safety guidelines that are both
feasible and effective for growers, processors, handlers, and
consumers.
Mr. Speaker, this legislation does offer a step forward, but be
certain that today we could have taken a leap forward.
I look forward to working with my colleagues, constituents and the
agencies to developing meaningful scientifically based food safety
standards. But unfortunately, I can not support this bill as it is
presented to us from the Senate.
Mr. VAN HOLLEN. Mr. Speaker, I rise in support of this legislation
that will provide the Food and Drug Administration, FDA, much-needed
enhanced authorities to protect the American public from unsafe foods.
Serious gaps have been exposed in the FDA's ability to protect the
American public from outbreaks of food-borne diseases. These outbreaks
have shaken consumer confidence in the industry that produces one of
our most basic and important commodities that Americans depend on
daily--the food we eat.
While I prefer the stronger food safety bill that the House passed
last year, the Senate-passed FDA Food Safety Modernization Act will
make substantial improvements to our food safety system. It includes
critical reforms that will improve the FDA's ability to better prevent
outbreaks and protect the safety of our food supply and it will allow
the FDA to conduct increased inspections, enhance surveillance and
traceability of food products, and give the FDA the authority to issue
mandatory recalls.
Mr. Speaker, we must ensure that the FDA has the necessary tools and
resources to fulfill its vital mission of helping protect the American
public from unsafe products. This food safety bill is an important part
of that effort. I urge my colleagues to support this legislation.
Mr. DINGELL. I yield back the balance of my time.
The SPEAKER pro tempore. All time for debate has expired.
Pursuant to House Resolution 1781, the previous question is ordered.
The question is on the motion by the gentleman from Michigan (Mr.
Dingell).
The question was taken; and the Speaker pro tempore announced that
the ayes appeared to have it.
Mr. PITTS. Mr. Speaker, on that I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to the order of the House of today,
further proceedings on this question will be postponed.
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