[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3937 Introduced in House (IH)]







110th CONGRESS
  1st Session
                                H. R. 3937

To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety 
                           of imported food.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 23, 2007

 Ms. DeLauro introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety 
                           of imported food.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Food Import Safety Act of 2007''.

SEC. 2. SAFETY OF IMPORTED FOOD.

    (a) Pattern of Violations.--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) If there is a pattern of violations of this Act with respect 
to food generally or any type of food imported or offered for import 
into the United States from a particular country, the Secretary by 
regulation may prohibit the importation of food or such type of food, 
respectively, from such country, as determined appropriate by the 
Secretary to protect the public health.''.
    (b) Certification of Foreign Facilities and Foreign Countries.--
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. CERTIFICATION OF FOREIGN FACILITIES AND FOREIGN COUNTRIES.

    ``(a) In General.--The Secretary shall establish a certification 
program in accordance with this section to ensure that food imported 
into the United States meets the food safety standards applied to food 
produced in the United States.
    ``(b) Requirement.--No food shall be permitted entry into the 
United States from a foreign facility in a foreign country unless there 
is--
            ``(1) a certification for such facility in effect under 
        subsection (c)(1); or
            ``(2) a certification for such country in effect under 
        subsection (c)(2).
    ``(c) Certification.--
            ``(1) Foreign facility.--Each foreign facility seeking to 
        import food into the United States may obtain a certification 
        by the Secretary stating that the facility maintains a program 
        using reliable analytical methods to ensure compliance with all 
        the food safety standards described in subsection (a).
            ``(2) Foreign country.--A foreign country may obtain a 
        certification by the Secretary stating that--
                    ``(A) the country has in effect and is enforcing 
                food safety standards at least as protective of food 
                safety as the standards applicable to food in the 
                United States; and
                    ``(B) the country has a program in effect to 
                monitor and enforce its food safety standards with 
                respect to food being exported from such country to the 
                United States.
    ``(d) Revocation of Certification.--The Secretary may, with respect 
to a foreign facility or foreign country, revoke a certification under 
subsection (c) if--
            ``(1) food from the foreign facility or foreign country is 
        linked to an outbreak of human illness;
            ``(2) the Secretary determines that the foreign facility or 
        foreign country is no longer meeting the requirements described 
        in subsection (c); or
            ``(3) United States officials are not allowed to conduct 
        such audits and investigations as may be necessary to carry out 
        this section.
    ``(e) Periodic Review.--The Secretary shall periodically review 
certifications under subsection (c) for compliance with the 
requirements of this section.
    ``(f) Duration of Certification.--Each certification under 
subsection (c) shall be for a period of not more than 5 years.
    ``(g) Inspection; Independent Audits.--In determining whether to 
issue a certification under subsection (c) or revoke a certification 
under subsection (d), the Secretary is authorized to--
            ``(1) inspect foreign facilities to ensure compliance with 
        the food safety standards described in subsection (a); and
            ``(2) consider independent audits, product test data, and 
        other relevant information generated by the facility, importer, 
        or foreign country involved.
    ``(h) Cooperation With Foreign Countries.--The Commissioner of Food 
and Drugs and other appropriate Federal agencies shall work with 
foreign countries that are major trading partners of the United States 
to establish certification programs described in subsection (c)(2).
    ``(i) Technical Assistance to Small Businesses.--The Secretary may 
provide technical assistance to small businesses in developing 
countries to assist such businesses in complying with the requirements 
of this section and meeting the food safety standards described in 
subsection (a).
    ``(j) Foreign Facility.--In this section, the term `foreign 
facility' means a foreign facility (as defined in section 415(b)(3)) 
that is required to be registered under section 415.
    ``(k) Effective Date.--This section takes effect beginning on the 
date that is 2 years after the date of the enactment of the Food Import 
Safety Act of 2007.''.

SEC. 3. NOTIFICATION AND RECALL.

    Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
341 et seq.), as amended by section 2(b), is amended by adding at the 
end the following:

``SEC. 419. NOTIFICATION AND RECALL.

    ``(a) Notice to Secretary of Violation.--
            ``(1) In general.--A person that has reason to believe that 
        any food introduced into or in interstate commerce, or held for 
        sale (whether or not the first sale) after shipment in 
        interstate commerce, may be in violation of this Act shall 
        immediately notify the Secretary of the identity and location 
        of the food.
            ``(2) Manner of notification.--Notification under paragraph 
        (1) shall be made in such manner and by such means as the 
        Secretary may require by regulation.
    ``(b) Recall and Consumer Notification; Voluntary Actions.--If the 
Secretary determines that food is in violation of this Act when 
introduced into or while in interstate commerce or while held for sale 
(whether or not the first sale) after shipment in interstate commerce 
and that there is a reasonable probability that the food, if consumed, 
would present a threat to public health, as determined by the 
Secretary, the Secretary shall give the appropriate persons (including 
the manufacturers, importers, distributors, or retailers of the food) 
an opportunity to--
            ``(1) cease distribution of the food;
            ``(2) notify all persons--
                    ``(A) processing, distributing, or otherwise 
                handling the food to immediately cease such activities 
                with respect to the food; or
                    ``(B) to which the food has been distributed, 
                transported, or sold, to immediately cease distribution 
                of the food;
            ``(3) recall the food;
            ``(4) in conjunction with the Secretary, provide notice of 
        the finding of the Secretary--
                    ``(A) to consumers to whom the food was, or may 
                have been, distributed; and
                    ``(B) to State and local public health officials; 
                or
            ``(5) take any combination of the measures described in 
        this subsection, as determined by the Secretary to be 
        appropriate in the circumstances.
    ``(c) Civil and Criminal Penalties.--
            ``(1) Civil sanctions.--
                    ``(A) Civil penalty.--Any person that commits an 
                act that violates the notification and recall standards 
                under subsection (b) (including a regulation 
                promulgated or order issued under this Act) may be 
                assessed a civil penalty by the Secretary of not more 
                than $10,000 for each such act.
                    ``(B) Separate offense.--Each act described in 
                subparagraph (A) and each day during which that act 
                continues shall be considered a separate offense.
            ``(2) Other requirements.--
                    ``(A) Written order.--The civil penalty described 
                in paragraph (1) shall be assessed by the Secretary by 
                a written order, which shall specify the amount of the 
                penalty and the basis for the penalty under 
                subparagraph (B) considered by the Secretary.
                    ``(B) Amount of penalty.--Subject to paragraph 
                (1)(A), the amount of the civil penalty shall be 
                determined by the Secretary, after considering--
                            ``(i) the gravity of the violation;
                            ``(ii) the degree of culpability of the 
                        person;
                            ``(iii) the size and type of the business 
                        of the person; and
                            ``(iv) any history of prior offenses by the 
                        person under this Act.
                    ``(C) Review of order.--The order may be reviewed 
                only in accordance with subsection (d).
            ``(3) Exception.--No person shall be subject to the 
        penalties of this subsection--
                    ``(A) for having received, proffered, or delivered 
                in interstate commerce any food, if the receipt, 
                proffer, or delivery was made in good faith, unless 
                that person refuses to furnish (on request of an 
                officer or employee designated by the Secretary)--
                            ``(i) the name, address, and contact 
                        information of the person from whom that person 
                        purchased or received the food;
                            ``(ii) copies of all documents relating to 
                        the person from whom that person purchased or 
                        received the food; and
                            ``(iii) copies of all documents pertaining 
                        to the delivery of the food to that person; or
                    ``(B) if that person establishes a guaranty signed 
                by, and containing the name and address of, the person 
                from whom that person received in good faith the food, 
                stating that the food is not adulterated or misbranded 
                within the meaning of this Act.
    ``(d) Judicial Review.--
            ``(1) In general.--An order assessing a civil penalty under 
        subsection (c) shall be a final order unless the person--
                    ``(A) not later than 30 days after the effective 
                date of the order, files a petition for judicial review 
                of the order in the United States court of appeals for 
                the circuit in which that person resides or has its 
                principal place of business or the United States Court 
                of Appeals for the District of Columbia; and
                    ``(B) simultaneously serves a copy of the petition 
                by certified mail to the Secretary.
            ``(2) Filing of record.--Not later than 45 days after the 
        service of a copy of the petition under paragraph (1)(B), the 
        Secretary shall file in the court a certified copy of the 
        administrative record upon which the order was issued.
            ``(3) Standard of review.--The findings of the Secretary 
        relating to the order shall be set aside only if found to be 
        unsupported by substantial evidence on the record as a whole.
    ``(e) Collection Actions for Failure To Pay.--
            ``(1) In general.--If any person fails to pay a civil 
        penalty assessed under subsection (c) after the order assessing 
        the penalty has become a final order, or after the court of 
        appeals described in subsection (d) has entered final judgment 
        in favor of the Secretary, the Secretary shall refer the matter 
        to the Attorney General, who shall institute in a United States 
        district court of competent jurisdiction a civil action to 
        recover the amount assessed.
            ``(2) Limitation on review.--In a civil action under 
        paragraph (1), the validity and appropriateness of the order of 
        the Secretary assessing the civil penalty shall not be subject 
        to judicial review.
    ``(f) Penalties Paid Into Account.--The Secretary--
            ``(1) shall deposit penalties collected under this section 
        in an account in the Treasury; and
            ``(2) may use the funds in the account, without further 
        appropriation or fiscal year limitation--
                    ``(A) to carry out enforcement activities under 
                food safety law; or
                    ``(B) to provide assistance to States to inspect 
                retail commercial food establishments, such as an 
                establishment that holds, stores, or transports food or 
                food ingredients, or other food or firms under the 
                jurisdiction of State food safety programs.
    ``(g) Discretion of the Secretary To Prosecute.--Nothing in this 
section, section 418, or section 420 requires the Secretary to report 
for prosecution, or for the commencement of an action, the violation of 
this Act in a case in which the Secretary finds that the public 
interest will be adequately served by the assessment of a civil penalty 
under this section.
    ``(h) Remedies Not Exclusive.--The remedies provided in this 
section may be in addition to, and not exclusive of, other remedies 
that may be available.''.

SEC. 4. MANDATORY RECALL AUTHORITY.

    Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
341 et seq.), as amended by section 3, is amended by adding at the end 
the following:

``SEC. 420. MANDATORY RECALL ACTION.

    ``(a) Mandatory Actions.--If a person referred to in section 419(b) 
refuses to or does not adequately carry out the actions described in 
that section within the time period and in the manner prescribed by the 
Secretary, the Secretary shall--
            ``(1) have authority to control and possess the food, 
        including ordering the shipment of the food from a food 
        establishment, such as an establishment that holds, stores, or 
        transports food or food ingredients, to the Secretary--
                    ``(A) at the expense of such food establishment; or
                    ``(B) in an emergency (as determined by the 
                Secretary), at the expense of the Secretary; and
            ``(2) by order, require, as the Secretary determines to be 
        necessary, the person to immediately--
                    ``(A) cease distribution of the food; and
                    ``(B) notify all persons--
                            ``(i) processing, distributing, or 
                        otherwise handling the food to immediately 
                        cease such activities with respect to the food; 
                        or
                            ``(ii) if the food has been distributed, 
                        transported, or sold, to immediately cease 
                        distribution of the food.
    ``(b) Notification to Consumers by Secretary.--The Secretary shall, 
as the Secretary determines to be necessary, provide notice of the 
finding of the Secretary under subsection (a)--
            ``(1) to consumers to whom the food was, or may have been, 
        distributed; and
            ``(2) to State and local public health officials.
    ``(c) Nondistribution by Notified Persons.--A person that 
processes, distributes, or otherwise handles the food, or to which the 
food has been distributed, transported, or sold, and that is notified 
under section 419(b)(2) or subsection (a)(2)(B) of this section shall 
immediately cease distribution of the food.
    ``(d) Availability of Records to Secretary.--Each person referred 
to in section 419 that processed, distributed, or otherwise handled 
food shall make available to the Secretary information necessary to 
carry out this section, as determined by the Secretary, regarding--
            ``(1) persons that processed, distributed, or otherwise 
        handled the food; and
            ``(2) persons to which the food has been transported, sold, 
        distributed, or otherwise handled.
    ``(e) Informal Hearings on Orders.--
            ``(1) In general.--The Secretary shall provide any person 
        subject to an order under subsection (a) with an opportunity 
        for an informal hearing, to be held as soon as practicable but 
        not later than 2 business days after the issuance of the order.
            ``(2) Scope of the hearing.--In a hearing under paragraph 
        (1), the Secretary shall consider the actions required by the 
        order and any reasons why the food that is the subject of the 
        order should not be recalled.
    ``(f) Post-Hearing Recall Orders.--
            ``(1) Amendment of order.--If, after providing an 
        opportunity for an informal hearing under subsection (e), the 
        Secretary determines that there is a reasonable probability 
        that the food that is the subject of an order under subsection 
        (a), if consumed, would present a threat to the public health, 
        the Secretary, as the Secretary determines to be necessary, 
        may--
                    ``(A) amend the order to require recall of the food 
                or other appropriate action;
                    ``(B) specify a timetable in which the recall shall 
                occur;
                    ``(C) require periodic reports to the Secretary 
                describing the progress of the recall; and
                    ``(D) provide notice of the recall to consumers to 
                whom the food was, or may have been, distributed.
            ``(2) Vacation of orders.--If, after providing an 
        opportunity for an informal hearing under subsection (e), the 
        Secretary determines that adequate grounds do not exist to 
        continue the actions required by the order, the Secretary shall 
        vacate the order.
    ``(g) Remedies Not Exclusive.--The remedies provided in this 
section shall be in addition to, and not exclusive of, other remedies 
that may be available.''.
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