[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2108 Introduced in House (IH)]







110th CONGRESS
  1st Session
                                H. R. 2108

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
                  safety of food for humans and pets.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 2, 2007

Ms. DeLauro (for herself, Ms. DeGette, Mr. Moran of Virginia, Mr. Gene 
     Green of Texas, Ms. Schakowsky, Ms. Matsui, and Mrs. Davis of 
 California) 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 with respect to the 
                  safety of food for humans and pets.

    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 ``Human and Pet Food Safety Act of 
2007''.

SEC. 2. FOOD SAFETY FOR HUMANS AND PETS.

    (a) Adverse Events; Inspections; Recall.--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. 417. 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 paragraph, 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 419 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. 418. MANDATORY RECALL ACTION.

    ``(a) Mandatory Actions.--If a person referred to in section 417(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 417(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 417 that processed, distributed, or otherwise handled 
food shall make available to the Secretary information necessary to 
carry out this subsection, as determined by the Secretary, regarding--
            ``(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.

``SEC. 419. FOREIGN INSPECTIONS; IMPORTS.

    ``(a) Authority To Inspect.--The Secretary shall have the authority 
to visit any foreign country that imports to the United States human or 
pet food. Such a visit shall be for the purpose of auditing the food 
safety or pet food programs of such foreign country or to conduct 
investigations in the event that a food or ingredient of a food is 
found to violate this Act.
    ``(b) Imports.--
            ``(1) In general.--Not later than 2 years after the date of 
        the enactment of this section, the Secretary shall establish a 
        system under which a foreign government or foreign 
        manufacturer, importer, distributor, or retailer that seeks to 
        import food to the United States shall submit a request for 
        certification to the Secretary.
            ``(2) Certification standard.--A foreign government or 
        foreign manufacturer, importer, distributor, or retailer 
        requesting a certification to import food to the United States 
        shall demonstrate, in a manner determined appropriate by the 
        Secretary, that food produced under the supervision of a 
        foreign government or by the foreign manufacturer, importer, 
        distributor, or retailer has met standards for food safety, 
        inspection, labeling, and consumer protection that are at least 
        equivalent to standards applicable to food produced in the 
        United States.
            ``(3) Certification approval.--
                    ``(A) Request by foreign government.--Prior to 
                granting the certification request of a foreign 
                government, the Secretary shall review, audit, and 
                certify the food safety program of a requesting foreign 
                government (including all statutes, regulations, and 
                inspection authority) as at least equivalent to the 
                food safety program in the United States, as 
                demonstrated by the foreign government.
                    ``(B) Request by foreign establishment.--Prior to 
                granting the certification request of a foreign 
                manufacturer, importer, distributor, or retailer that 
                seeks to import food to the United States, the 
                Secretary shall certify, based on an onsite inspection, 
                the food safety programs and procedures of a requesting 
                foreign firm as at least equivalent to the food safety 
                programs and procedures of the United States.
            ``(4) Limitation.--A foreign government or foreign 
        manufacturer, importer, distributor, or retailer approved by 
        the Secretary to import food to the United States under this 
        section shall be certified to export only the approved food 
        products to the United States for a period not to exceed 5 
        years.
            ``(5) Withdrawal of certification.--The Secretary may 
        withdraw certification of any food from a foreign government or 
        foreign manufacturer, importer, distributor, or retailer that 
        seeks to import food to the United States--
                    ``(A) if such food is linked to an outbreak of 
                human illness;
                    ``(B) following an investigation by the Secretary 
                that finds that the food safety programs and procedures 
                of the foreign government or foreign manufacturer, 
                importer, distributor, or retailer are no longer 
                equivalent to the food safety programs and procedures 
                in the United States; or
                    ``(C) following a refusal to allow United States 
                officials to conduct such audits and investigations as 
                may be necessary to fulfill the requirements under this 
                section.
            ``(6) Renewal of certification.--The Secretary shall audit 
        a foreign government and a foreign manufacturer, importer, 
        distributor, or retailer that seeks to import food to the 
        United States at least every 5 years to ensure the continued 
        compliance with the standards set forth in this section.
            ``(7) Required routine inspection.--The Secretary shall 
        routinely inspect food and food animals (via a physical 
        examination) before it enters the United States to ensure that 
        it is--
                    ``(A) safe;
                    ``(B) labeled as required for food produced in the 
                United States; and
                    ``(C) otherwise meets requirements under this Act.
            ``(8) Records inspection.--
                    ``(A) In general.--The responsible party or 
                importer shall permit an authorized person to have 
                access to records required to be maintained under this 
                section during an inspection pursuant to section 704.
                    ``(B) Definitions.--For purposes of this 
                paragraph--
                            ``(i) the term `authorized person' means an 
                        officer or employee of the Department of Health 
                        and Human Services, who has--
                                    ``(I) appropriate credentials, as 
                                determined by the Secretary; and
                                    ``(II) been duly designated by the 
                                Secretary to have access to the records 
                                required under this section; and
                            ``(ii) the term `responsible party' means, 
                        with respect to an article of food, any person 
                        responsible for the manufacturing, processing, 
                        packaging, or holding for such food for 
                        consumption in the United States.
            ``(9) Enforcement.--The Secretary is authorized to--
                    ``(A) deny importation of food from any foreign 
                government that does not permit United States officials 
                to enter the foreign country to conduct such audits and 
                inspections as may be necessary to fulfill the 
                requirements under this section;
                    ``(B) deny importation of food from any foreign 
                government or foreign manufacturer, importer, 
                distributor, or retailer that does not consent to an 
                investigation by the Administration when food from that 
                foreign country or foreign firm is linked to a 
                foodborne illness outbreak or is otherwise found to be 
                adulterated or mislabeled; and
                    ``(C) promulgate rules and regulations to carry out 
                the purposes of this section, including setting terms 
                and conditions for the destruction of products that 
                fail to meet the standards of this Act.
            ``(10) Detention and seizure.--Any food imported for 
        consumption in the United States may be detained, seized, or 
        condemned pursuant to section 418.''.

SEC. 3. ENSURING EFFICIENT AND EFFECTIVE COMMUNICATIONS DURING A 
              RECALL.

    The Secretary, during an ongoing recall of human or pet food, 
shall--
            (1) work with companies, relevant professional 
        associations, and other organizations to collect and aggregate 
        information pertaining to the recall;
            (2) use existing networks of communication including 
        electronic forms of information dissemination to enhance the 
        quality and speed of communication with the public; and
            (3) post information regarding recalled products on the 
        Internet website of the Food and Drug Administration in a 
        consolidated, searchable form that is easily accessed and 
        understood by the public.

SEC. 4. ENSURING THE SAFETY OF PET FOOD.

    (a) Processing and Ingredient Standards.--Not later than 18 months 
after the date of the enactment of this Act, the Secretary of Health 
and Human Services (referred to in this section as the ``Secretary''), 
in consultation with the Association of American Feed Control 
Officials, and other relevant stakeholder groups, including veterinary 
medical associations, animal health organizations, and pet food 
manufacturers, shall by regulation establish--
            (1) processing and ingredient standards with respect to 
        feed, pet food, animal waste, and ingredient definitions; and
            (2) updated standards for the labeling of pet food that 
        includes nutritional information and ingredient information.
    (b) Early Warning Surveillance Systems and Notification During Pet 
Food Recalls.--
            (1) In general.--Not later than 180 days after the date of 
        the enactment of this Act, the Secretary shall by regulation 
        establish an early warning and surveillance system to identify 
        contaminations of the pet food supply and outbreaks of illness 
        from pet food. In establishing such system, the Secretary 
        shall--
                    (A) use surveillance and monitoring mechanisms 
                similar to, or in coordination with, those mechanisms 
                used by the Centers for Disease Control and Prevention 
                to monitor human health, such as the Foodborne Diseases 
                Active Surveillance Network (FoodNet) and PulseNet;
                    (B) consult with relevant professional associations 
                and private sector veterinary hospitals; and
                    (C) work with Health Alert Networks and other 
                notification networks to inform veterinarians and 
                relevant stakeholders during any recall of pet food.
            (2) Authorization of appropriations.--There are authorized 
        to be appropriated to carry out paragraph (1) such sums as may 
        be necessary.

SEC. 5. SENSE OF THE HOUSE OF REPRESENTATIVES.

    (a) Findings.--Congress finds that--
            (1) the safety and integrity of the United States food 
        supply is vital to the public health, to public confidence in 
        the food supply, and to the success of the food sector of the 
        Nation's economy;
            (2) illnesses and deaths of individuals and companion pets 
        caused by contaminated food--
                    (A) have contributed to a loss of public confidence 
                in food safety; and
                    (B) have caused significant economic losses to 
                manufacturers and producers not responsible for 
                contaminated food items;
            (3) the task of preserving the safety of the food supply of 
        the United States faces tremendous pressures with regard to--
                    (A) emerging pathogens and other contaminants and 
                the ability to detect all forms of contamination; and
                    (B) an increasing volume of imported food, without 
                adequate monitoring and inspection;
            (4) the United States is increasing the amount of food that 
        it imports such that--
                    (A) from 2003 to the present, the value of food 
                imports has increased from $45,600,000,000 to 
                $64,000,000,000; and
                    (B) imported food accounts for 13 percent of the 
                average Americans diet, including 31 percent of fruits, 
                juices, and nuts, 9.5 percent of red meat, and 78.6 
                percent of fish and shellfish; and
            (5) the number of full-time equivalent Food and Drug 
        Administration employees conducting inspections has decreased 
        during the period between 2003 and 2007.
    (b) Sense of the House of Representatives.--It is the sense of the 
House of Representatives that--
            (1) it is vital for Congress to provide the Food and Drug 
        Administration with additional resources, authorities, and 
        direction with respect to ensuring the safety of the food 
        supply of the United States;
            (2) additional Food and Drug Administration inspectors are 
        required if we are to improve Food and Drug Administration's 
        ability to safeguard the food supply of the United States; and
            (3) because of the increasing volume of international trade 
        in food products the Secretary of Health and Human Services 
        should make it a priority to enter into agreements, including 
        memoranda of understanding, with the trading partners of the 
        United States with respect to food safety.

SEC. 6. ANNUAL REPORT TO CONGRESS.

    The Secretary of Health and Human Services shall, on an annual 
basis, submit to the Committee on Energy and Commerce and the Committee 
on Appropriations of the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions and the Committee on 
Appropriations of the Senate a report that includes, with respect to 
the preceding 1-year period--
            (1) the number and amount of food products imported into 
        the United States, aggregated by country and type of food, if 
        any;
            (2) a listing of the number of inspectors of imported food 
        products and the number of inspections performed on such 
        products; and
            (3) aggregated data on the findings of such inspections, 
        including data related to violations of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 201 et seq.), and enforcement 
        mechanisms used with respect to such findings and violations.
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