In the nature of a substitute, to modernize Federal food safety efforts without placing unnecessary burdens on food producers, increasing food prices, or saddling taxpayers with additional debt.

SA 4696. Mr. COBURN submitted an amendment intended to be proposed by
him to the bill S. 510, to amend the Federal Food, Drug, and Cosmetic
Act with respect to the safety of the food supply; which was ordered to
lie on the table; as follows:

Strike all after the enacting clause and insert the
following:

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title.--This Act may be cited as the ``Ensuring
Greater Food Safety Act of 2010''.
(b) Table of Contents.--The table of contents for this Act
is as follows:

Sec. 1. Short title; table of contents.
Sec. 2. Ensuring Federal agencies effectively communicate to ensure
greater food safety.
Sec. 3. Strategic plan for health information technology.
Sec. 4. Expediting new food safety technologies.
Sec. 5. Limited access to records in public health emergencies.
Sec. 6. Registration of food facilities.
Sec. 7. Clarifying FDA authority to require preventive controls.
Sec. 8. Export certification fees for foods and animal feed.
Sec. 9. Leveraging third party inspections.
Sec. 10. Entry of food from facilities inspected by an accredited third
party.
Sec. 11. Activities with other governments.
Sec. 12. Compliance with international agreements.

SEC. 2. ENSURING FEDERAL AGENCIES EFFECTIVELY COMMUNICATE TO
ENSURE GREATER FOOD SAFETY.

(a) In General.--Notwithstanding any other provision of
law, not later than 60 days after the date of enactment of
this Act, the Secretary of Health and Human Services and the
Secretary or Agriculture shall establish a plan to ensure
effective information sharing regarding the regulation and
inspection of food products and facilities, including
violations, in which the Food and Drug Administration and the
Department of Agriculture share joint, overlapping, or
similar responsibility.
(b) Joint Report.--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 shall issue to
Congress a joint report that summarizes the effectiveness, or
lack of effectiveness, of the new information sharing
arrangement established pursuant to subsection (a).
(c) GAO Report.--Not later than 1 year after the issuance
of the report under subsection (b), the Comptroller General
of the United States shall issue to Congress a report
concerning the determination and description of any
inefficiencies or other challenges that remain regarding the
sharing of information as required pursuant to subsection
(a).

SEC. 3. STRATEGIC PLAN FOR HEALTH INFORMATION TECHNOLOGY.

Not later than 1 year after the date of enactment of this
Act, the Secretary of Health and Human Services shall submit
to the Committee on Health, Education, Labor, and Pensions
and the Committee on Appropriations of the Senate and the
Committee on Energy and Commerce and the Committee on
Appropriations of the House of Representatives, a strategic
plan on information technology that includes--
(1) an assessment of the information technology
infrastructure, including systems for food safety data
collection, access to data in external food safety databases,
data mining capabilities, personnel, and personnel training
programs, needed by the Food and Drug Administration to--
(A) comply with the requirements of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.);
(B) achieve interoperability within the Center for Food
Safety and Nutrition and between the Food and Drug
Administration and the Department of Agriculture, U.S.
Customs and Border Protection, and the Centers for Disease
Control and Prevention;
(C) utilize electronic import and recall records; and
(D) communicate food safety and recall information to
industry and the public;
(2) an assessment of the extent to which the current
information technology assets of the Food and Drug
Administration are sufficient to meet the needs assessments
under paragraph (1);
(3) a plan for enhancing the information technology assets
of the Food and Drug Administration toward meeting the needs
assessments under paragraph (1); and
(4) an assessment of additional resources needed to so
enhance the information technology assets of the Food and
Drug Administration.

SEC. 4. EXPEDITING NEW FOOD SAFETY TECHNOLOGIES.

(a) In General.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs,
shall submit to Congress a plan for a more expeditious
process for approving new technologies used to ensure the
safety of the food supply.
(b) Content.--The report submitted under subsection (a)
shall include a description of how the Food and Drug
Administration plans to provide more effective risk-
communication regarding new technologies described in such
report that are approved by such Administration.

SEC. 5. LIMITED ACCESS TO RECORDS IN PUBLIC HEALTH
EMERGENCIES.

(a) Maintenance and Inspection of Records.--Section 414 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350c) is
amended--
(1) in subsection (a)--
(A) by inserting ``or a related article of food'' after
``such article'' each place the term appears;

[[Page S7987]]

(B) by inserting ``or a related article of food'' after
``whether the food''; and
(C) by adding at the end the following: ``In this
subsection, the term `related article of food' means an
article of food that is related to the article of food the
Secretary has reason to believe is adulterated, such as an
article of food produced on the same manufacturing line as
the article of food believed to be adulterated.''; and
(2) by adding at the end the following:
``(e) Food-related Emergencies.--In the case of a food-
related public health emergency declared by the Secretary
under section 319 of the Public Health Service Act, the
Secretary may take action as described in subsection (a) if
the Secretary has a reasonable belief that such article of
food--
``(1) presents a threat of serious adverse health
consequences or death; and
``(2) is related to the emergency.''.
(b) Factory Inspection.--Section 704(a)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)) is amended
in the second sentence by inserting ``, and in the case of a
food-related public health emergency declared by the
Secretary under section 319 of the Public Health Service Act,
the inspection shall extend to all records and other
information described in section 414 if the Secretary has a
reasonable belief that such article of food presents a threat
of serious adverse health consequences or death and is
related to the emergency, subject to the limitations
established in section 414(d)'' before the period at the end.

SEC. 6. REGISTRATION OF FOOD FACILITIES.

Section 415(a) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 350d(a)) is amended--
(1) in paragraph (2), by inserting ``(or any successor
regulation)'' after ``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 reregistration.--
``(A) In general.--On a biennial basis, a registrant that
has registered under paragraph (1) shall submit to the
Secretary a reregistration containing the information
described in paragraph (2).
``(B) Expedited reregistration.--The Secretary may provide
for an expedited reregistration process in the case of a
registrant for which the information described in paragraph
(2) has not changed since the preceding registration or
reregistration.''.

SEC. 7. CLARIFYING FDA AUTHORITY TO REQUIRE PREVENTIVE
CONTROLS.

Chapter IV of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 341 et seq.) is amended by adding at the end the
following:

``SEC. 418. PREVENTIVE CONTROLS.

``(a) Definitions.--In 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, as a result, an identified
food safety hazard can be prevented, eliminated, or reduced
to acceptable levels.
``(2) Critical limit.--The term `critical limit' means the
maximum or minimum value to which a physical, biological, or
chemical parameter must be controlled at a critical control
point to prevent, eliminate, or reduce to an acceptable level
the occurrence of the identified food safety hazard.
``(b) Regulations by Secretary.--The Secretary--
``(1) may by regulation require manufacturers, processors,
and packers of food to implement science-based and risk-based
processes to prevent, reduce, or eliminate specific hazards
from high-risk foods; and
``(2) may issue guidance to assist the relevant industry
with compliance with this section.
``(c) Limitation.--The Secretary shall not have the
authority to place any specific requirements on food safety
plans required pursuant to subsection (d)(1). The authority
of the Secretary under this section is limited to validating
the existence of a food safety plan that meets the explicit
statutory requirements provided in this section.
``(d) Content.--
``(1) Determination.--The regulations under subsection (b)
shall include a determination specifying the food facilities
which shall be required to develop and maintain a written
food safety plan. The determination shall include a careful
examination of the effect on small businesses and shall
include specific exemptions for firms that will be adversely
impacted by the requirements of this section.
``(2) Requirement.--The regulations under subsection (b)
shall require that a required food safety plan--
``(A) list the food safety hazards which the plan is
intended to address;
``(B) list the critical control points for each of the
identified food safety hazards;
``(C) list the critical limits that must be met at each of
the critical control points;
``(D) list the procedures, and frequency thereof, that will
be used to monitor each of the critical control points to
ensure compliance with the critical limits;
``(E) include any corrective action plans that have been
developed to be followed in response to deviations from
critical limits at critical control points to either prevent
the food from entering commerce, or for correcting the
deviation;
``(F) list the verification procedures, and frequency
thereof, that the manufacturer, processor, packer will use to
ensure the plan is adequate to control identified food safety
hazards and that the plan is being effectively implemented;
``(G) provide for a recordkeeping system that documents the
acceptance and implementation of the plan, including
calibration of instruments, monitoring of the critical
control points, and corrective actions;
``(H) establish a schedule for periodic reassessment of the
adequacy of the plan which shall be at least annually and
whenever any changes occur that could affect the hazard
analysis or alter the food safety plan; and
``(I) be modified immediately whenever a reassessment or
ongoing verification reveals that the plan is no longer
adequate to fully meet the requirements of this section.
``(3) Description.--The regulations under subsection (b)
shall describe, as the Secretary determines necessary, any
evidence that shall be required to accompany food imported or
offered for import into the United States to verify that the
food was manufactured, processed, or packed under conditions
that comply with this Act. Such evidence shall be of a
similar nature and stringency to that which is required by
the regulations for food manufactured, processed, or packed
in the United States.
``(e) Official Review.--All records, food safety plans, and
procedures required by this section shall be made available
to the Secretary upon request for official review and copying
at reasonable times. In conducting such a review, the
authority of the Secretary shall be limited to validating the
existence of the plan and the Secretary shall not have the
authority to alter the plan or require specific items with
the plan.
``(f) Public Disclosure.--All food safety plans and records
required by this section shall not be made available for
public disclosure unless such plans and records are data and
information previously disclosed to the public (as described
in section 20.81 of title 21, Code of Federal Regulations),
or such plans and records relate to a food or ingredient that
has been abandoned and such plans and records no longer
represent a trade secret or confidential commercial or
financial information (as described in section 20.61 of title
21, Code of Federal Regulations).
``(g) Imports.--
``(1) In general.--The Secretary may establish additional
or substitute methods and requirements to apply to foreign
manufacturers, processors, and packers of food that are of
similar stringency to the methods and requirements applicable
to domestic manufacturers, processors, and packers of food.
Such methods or requirements shall ensure that--
``(A) food imported or offered for import into the United
States is manufactured, processed, and packed in accordance
with this Act; and
``(B) food manufactured, processed, or packed in a foreign
country is evaluated for compliance with this Act in a
similar manner as food manufactured, processed, or packed in
the United States.
``(2) Competent third party.--An importer may contract with
a competent third party to assist with or perform any or all
of the verification activities specified in this section.
``(h) Exceptions.--The regulations in this section shall
not apply to--
``(1) harvesting food, without otherwise engaging in
processing;
``(2) the operation of a retail establishment;
``(3) the manufacturing, processing, or packing of seafood
or fresh juice; and
``(4) small producers that demonstrate in writing to the
Secretary that complying with such regulations would
adversely impact their operations.''.

SEC. 8. EXPORT CERTIFICATION FEES FOR FOODS AND ANIMAL FEED.

(a) Authority for Export Certifications for Food, Including
Animal Feed.--Section 801(e)(4)(A) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381(e)(4)(A)) is amended--
(1) in the matter preceding clause (i), by striking ``a
drug'' and inserting ``a food, drug'';
(2) in clause (i) by striking ``exported drug'' and
inserting ``exported food, drug''; and
(3) in clause (ii) by striking ``the drug'' each place it
appears and inserting ``the food, drug''.
(b) Treatment of Fees.--Section 801(e)(4) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)(4)) is
amended--
(1) by amending subparagraph (B) to read as follows:
``(B) If the Secretary issues a written export
certification within the 20 days prescribed by subparagraph
(A), a fee for such certification may be charged but shall
not exceed $175 for each certification.''; and
(2) by inserting after subparagraph (B) the following:
``(C) With respect to fees collected for a fiscal year
pursuant to subparagraph (B), the following shall apply:
``(i) In the case of fees for certification of exported
drugs, animal drugs, or devices, be credited to the
appropriation account for salaries and expenses of the Food
and Drug Administration and be available in accordance with
appropriations Acts until expended, without fiscal year
limitation. To cover the cost of issuing such certifications,
such sums as necessary may be transferred from such
appropriation account for salaries and expenses of the Food
and Drug Administration

[[Page S7988]]

without fiscal year limitation to such appropriation account
for salaries and expenses with fiscal year limitation.
``(ii) In the case of fees for certification of exported
foods, be credited to the Food and Drug Administration User
Fee Account and be available in accordance with
appropriations Acts until expended, without fiscal year
limitation.''.
(c) Clarification of Certification.--Section 801(e)(4) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381(e)(4)), as amended by subsection (b), is amended by
adding at the end the following:
``(D) For purposes of this paragraph, a certification by
the Secretary shall be made on such basis, and in such form
(which may include a publicly available listing) as the
Secretary determines appropriate.''.

SEC. 9. LEVERAGING THIRD PARTY INSPECTIONS.

(a) In General.--Section 704 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374) is amended by adding at the end
the following:
``(h) Accreditation of Entities That Inspect Domestic
Facilities or Foreign Facilities.--
``(1) Definitions.--In this subsection:
``(A) Domestic facility.--The term `domestic facility' has
the meaning given the term in section 415.
``(B) Foreign facility.--The term `foreign facility' has
the meaning given the term in section 415.
``(2) Voluntary use of accredited entities by facilities.--
A domestic facility or foreign facility may employ an entity
accredited under this subsection to inspect such facility to
ensure compliance with this Act.
``(3) Authorization.--
``(A) In general.--Not later than 1 year after the date of
enactment of the Ensuring Greater Food Safety Act of 2010,
the Secretary, subject to subparagraph (B), shall accredit
entities for the purpose of inspecting domestic facilities or
foreign facilities to ensure compliance with this Act. Such
entities may include State governments or foreign government
entities.
``(B) Criteria to accredit entities and categories of
accreditation.--
``(i) In general.--Not later than 180 days after the date
of enactment of the Ensuring Greater Food Safety Act of 2010,
the Secretary shall publish in the Federal Register criteria
to accredit entities, including the requirements described in
clause (iii), and the categories of accreditation.
``(ii) Consultation.--In developing the criteria and
categories described in clause (i), the Secretary shall
consult with the Secretary of Agriculture, the Secretary of
Commerce, and the heads of other agencies with experience in
accrediting third parties to determine the accreditation
categories and criteria that are most appropriate.
``(iii) Requirements to become accredited.--In order for an
entity to be accredited under this subsection, the entity
shall, at a minimum, meet the following requirements:

``(I) Such entity may not be an employee of the Federal
Government.
``(II) Such entity shall be an independent organization
that is not owned or controlled by a manufacturer, supplier,
or vendor of food regulated under this Act and that has no
organizational, material, or financial affiliation (including
a consultative affiliation) with such a manufacturer,
supplier, or vendor.
``(III) Such entity shall be legally constituted and
permitted to conduct the inspection activities for which it
seeks accreditation.
``(IV) Such entity may not engage in the design,
manufacture, promotion, or sale of food regulated under this
Act.
``(V) The operations of such entity shall be in accordance
with generally accepted professional and ethical business
practices, and such entity shall agree in writing that, at a
minimum, the entity will--

``(aa) certify that reported information accurately
reflects data reviewed, inspection observations made, other
matters that relate to or may influence compliance with this
Act, and recommendations made during an inspection or at an
inspection's closing meeting;
``(bb) limit work to that for which competence and capacity
are available;
``(cc) treat information received, records, reports, and
recommendations as confidential commercial or financial
information or trade secret information, except such
information may be made available to the Secretary; and
``(dd) promptly respond and attempt to resolve complaints
regarding its activities for which it is accredited.
``(iv) Categories of accreditation.--The categories of
accreditation may include--

``(I) inspection of domestic facilities only;
``(II) inspection of foreign facilities only; or
``(III) inspection of both domestic facilities and foreign
facilities.

``(C) Acting on request for accreditation.--
``(i) Information on adequacy.--Not later than 60 days
after the date the Secretary receives a request from an
entity to be accredited under this subsection, the Secretary
shall inform the entity whether the request for accreditation
is adequate for review.
``(ii) Determination.--Not later than 90 days after the
date the Secretary informs an entity under clause (i), the
Secretary shall make a determination with respect to the
request.
``(D) Content of accreditation.--Any accreditation granted
under this subsection shall state that the entity is
accredited to conduct inspections at domestic facilities,
foreign facilities, or both, or such other categories as may
be applicable.
``(E) Effect of subsection.--Nothing in this subsection
shall affect the authority of the Secretary under this Act to
inspect any domestic facility or foreign facility.
``(4) Requirements of accredited entities.--
``(A) Maintenance of records.--
``(i) In general.--An entity accredited under this
subsection shall maintain records documenting--

``(I) the qualifications of the entity to inspect and the
training and qualification of employees of the entity;
``(II) the procedures used by the entity for handling
confidential information;
``(III) the compensation arrangements made by the entity;
and
``(IV) the procedures used by the entity to identify and
avoid conflicts of interest.

``(ii) Access to records.--Upon the request of an officer
or employee designated by the Secretary, an entity accredited
under this subsection shall permit the officer or employee,
at all reasonable times, to have access to, copy, and verify
the records described in clause (i).
``(iii) Production of records.--Not later than 15 days
after the date an entity accredited under this subsection
receives a written request from the Secretary for a copy of
the records described in clause (i), the entity shall produce
the copy at the place designated by the Secretary.
``(B) Inspection reports.--
``(i) In general.--In carrying out an inspection of a
domestic facility or foreign facility to ensure compliance
with this Act, an entity accredited under this subsection
shall--

``(I) record in writing the entity's inspection
observations;
``(II) present the observations to the facility's
designated representative and describe each observation; and
``(III) prepare an inspection report (including for
inspections for which there are no corrective actions needed)
in a form and manner consistent with such reports prepared by
employees and officials designated by the Secretary to
conduct inspections.

``(ii) Content of report.--An inspection report prepared
under clause (i)(III) shall, at a minimum--

``(I) identify the person responsible for compliance with
this Act at the inspected facility, the dates of the
inspection, and the scope of the inspection;
``(II) describe in detail each observation identified by
the entity accredited under this subsection;
``(III) identify other matters that relate to or may
influence compliance with this Act; and
``(IV) describe any recommendations made by the entity
accredited under this subsection to the inspected facility
during the inspection or at the inspection's closing meeting.

``(iii) Report sent to the secretary.--Not later than 10
days after the last date of an inspection, the entity
accredited under this subsection shall submit the inspection
report prepared under clause (i)(III) to the Secretary and
the designated representative of the inspected facility at
the same time. The inspection report submitted to the
Secretary shall be accompanied by all written inspection
observations previously provided to the designated
representative of the inspected facility.
``(iv) False statements.--Any statement or representation
made by an employee or agent of a domestic facility or
foreign facility to an entity accredited under this
subsection shall be subject to section 1001 of title 18,
United States Code.
``(v) Immediate notification.--If, at any time during an
inspection by an entity accredited under this subsection, the
entity discovers a condition that could cause or contribute
to an unreasonable risk to the public health, the entity
shall immediately notify the Secretary of the identity of the
facility subject to inspection and such condition.
``(5) Requirements of the secretary.--
``(A) Publication of list of accredited entities on
internet.--
``(i) In general.--The Secretary shall publish on the
Internet Web site of the Food and Drug Administration lists
of entities that are accredited under this subsection in each
category established under this subsection.
``(ii) Updating lists.--The lists described in clause (i)
shall be updated to ensure that the identity of each entity
accredited under this subsection, and the particular category
for which the entity is accredited, is known to the public.
The lists shall be updated not later than 30 days after the
date on which--

``(I) an entity is accredited under this subsection;
``(II) the accreditation of an entity under this subsection
is suspended or withdrawn; or
``(III) the particular category for which an entity is
accredited under this subsection is modified.

``(B) Audits; withdrawal; debarment.--
``(i) In general.--To ensure that entities accredited under
this subsection continue to meet the standards of
accreditation, the Secretary shall--

``(I) audit the performance of such entities on a periodic
basis through the review of inspection reports and
inspections by the Secretary to evaluate the compliance
status of a

[[Page S7989]]

domestic facility or foreign facility and the performance of
entities accredited under this subsection; and
``(II) take such additional measures as the Secretary
determines to be appropriate.

``(ii) Withdrawal.--

``(I) In general.--The Secretary may withdraw accreditation
of an entity accredited under this subsection, after
providing notice and an opportunity for an informal hearing,
if--

``(aa) such entity is substantially not in compliance with
the standards of accreditation;
``(bb) such entity poses a threat to public health;
``(cc) such entity fails to act in a manner that is
consistent with the purposes of this subsection; or
``(dd) the Secretary determines that there is a financial
conflict of interest in the relationship between such entity
and the owner or operator of a domestic facility or foreign
facility that the entity has inspected under this subsection.

``(II) Suspension.--The Secretary may suspend accreditation
of an entity during the pendency of the process under
subclause (I).

``(iii) Debarment.--If the Secretary determines that an
entity accredited under this subsection has violated section
301(y), the Secretary--

``(I) shall withdraw such entity's accreditation under this
subsection; and
``(II) may permanently debar a responsible person for such
entity from being accredited and from carrying out inspection
activities under this subsection.

``(6) Fees.--An entity accredited under this subsection may
charge a domestic facility or foreign facility reasonable
fees for inspection services.
``(7) Symbol indicating inspection by an accredited
entity.--The Secretary may by regulation establish one or
more tamper-resistant symbols indicating that an article of
food was produced in a domestic or foreign facility that
passed an accredited third party inspection. Such a symbol
may be affixed on the packaging of such an article.
``(8) Electronic import certificates.--If the standards,
processes, and criteria to certify articles of food used by a
foreign regulatory authority of an exporting country or an
entity accredited under this subsection are sufficient to
ensure compliance with this Act, the Secretary shall enter
into agreements with such regulatory authority or such
accredited entity to electronically certify each food
shipment or class of shipments of designated food for
compliance with this Act prior to shipment. Such agreements
shall include provision of electronic certificates from such
regulatory authority or such accredited entity to accompany
each shipment. The Secretary shall provide criteria for such
certificates to ensure a secure system that prevents
counterfeiting of the certificates and takes into
consideration possible transshipment of products as a way to
avoid certification.
``(9) Consideration.--Notwithstanding any other provision
of law, the Secretary shall consider inspections performed by
accredited entities under this subsection, as well as other
private food safety contracts, when determining the overall
inspection schedule of the Food and Drug Administration in
order to focus on higher-risk facilities.''.
(b) Prohibited Acts.--Section 301(y) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(y)) is amended--
(1) in paragraph (1), by inserting ``or an entity
accredited under section 704(h)'' after ``523'';
(2) in paragraph (2)--
(A) by inserting ``or an entity accredited under section
704(h)'' after ``523''; and
(B) by inserting ``or entity'' after ``such person''; and
(3) in paragraph (3)--
(A) by inserting ``or an entity accredited under section
704(h)'' after ``523'';
(B) by inserting ``or entity'' after ``by such person'';
and
(C) by inserting ``or entity'' after ``to such person''.

SEC. 10. ENTRY OF FOOD FROM FACILITIES INSPECTED BY AN
ACCREDITED THIRD PARTY.

Section 801 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 381) is amended by adding at the end the following:
``(p) Entry of Food From Facilities Inspected by an
Accredited Third Party.--If an article of food is being
imported or offered for import at a port of entry into the
United States and such article of food is from a foreign
facility at which an inspection by an entity accredited under
section 704(h) was completed prior to the production of such
article of food at such facility and--
``(1) the results of the inspection were no official action
indicated, the Commissioner of Food and Drugs agrees with the
results of the inspection, and such facility has a
certificate described under section 704(h)(8), then the
article of food shall be presumed to be admissible into the
United States and shall not be detained or refused admission
but shall receive permission for expedited entry into the
United States;
``(2) the results of the inspection were voluntary action
indicated and the Commissioner of Food and Drugs agrees with
the results of the inspection, then the article of food shall
be subject to increased random inspection at the border; or
``(3) the results of the inspection were official action
indicated and the Commissioner of Food and Drugs agrees with
the results of the inspection, then the article of food
shall--
``(A) be--
``(i) held at the port of entry for the article without
physical examination and refused admission if the inspection
failure was due to a condition presenting a reasonable
probability that the use of or exposure to the article of
food will cause serious adverse health consequences or death;
or
``(ii) placed on import alert if the inspection failure was
due to a condition in which use of or exposure to the article
of food may cause temporary or medically reversible adverse
health consequences or where the probability of serious
adverse health consequences is remote; and
``(B) be subject to other actions as provided under this
Act.''.

SEC. 11. ACTIVITIES WITH OTHER GOVERNMENTS.

(a) Meetings and Agreements.--
(1) In general.--In carrying out the functions of the
Office of International Programs of the Food and Drug
Administration, the Secretary of Health and Human Services
(referred to in this section as the ``Secretary'')--
(A) shall regularly participate in meetings with
representatives of foreign governments to discuss and reach
agreement on methods and approaches to harmonize regulatory
requirements; and
(B) may enter into an agreement with a foreign entity to
facilitate commerce in food between the United States and
such entity--
(i) consistent with the requirements of this Act and the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.);
and
(ii) in which the Secretary shall encourage the mutual
development and recognition of--

(I) good manufacturing practice regulations; and
(II) other regulations and testing protocols as the
Secretary determines to be appropriate.

(2) Joint inspection.--An agreement entered into pursuant
to paragraph (1)(B) may include joint inspection missions
where an inspection team is composed of individuals from
regulatory authorities of both countries.
(b) Reduction of Regulation Burden and Harmonization of
Food Regulatory Requirements.--The Secretary shall support
the Office of the United States Trade Representative, in
consultation with the Secretary of Commerce, in meetings with
representatives of foreign governments to discuss methods and
approaches to reduce the burden of regulation and harmonize
food regulatory requirements if the Secretary determines that
such harmonization continues consumer protections consistent
with the purposes of this Act and the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.).

SEC. 12. 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.
______