[Congressional Record Volume 153, Number 71 (Wednesday, May 2, 2007)]
[Senate]
[Pages S5508-S5510]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DURBIN:
  S. 1274. A bill to amend the Federal Food, Drug, and Cosmetic Act 
with respect to the safety of food for humans and pets; to the 
Committee on Health, Education, Labor, and Pensions.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 1274

       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

[[Page S5509]]

     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 
     paragraph (1)--
       ``(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 
     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) Defintions.--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 food-borne 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 shall, during an ongoing recall of human or 
     pet food shall--
       (1) work with companies, relevant professional 
     associations, and other organizations

[[Page S5510]]

     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 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 
     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 SENATE.

       (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 loses to manufactures 
     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 
     from 2003 to 2007.
       (b) Sense of the Senate.--It is the sense of the Senate 
     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 Service shall, on an 
     annual basis, 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 
     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 to follow-up on such findings and 
     violations.

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