HR 3937 IHCommentsClose CommentsPermalink

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

October 23, 2007

Ms. DELAURO introduced the following bill; which was referred to the Committee on Energy and CommerceCommentsClose CommentsPermalink

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

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

SECTION 1. SHORT TITLE.

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

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:CommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink





(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:CommentsClose CommentsPermalink

`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.CommentsClose CommentsPermalink





`(b) Requirement- No food shall be permitted entry into the United States from a foreign facility in a foreign country unless there is--CommentsClose CommentsPermalink





`(1) a certification for such facility in effect under subsection (c)(1); orCommentsClose CommentsPermalink





`(2) a certification for such country in effect under subsection (c)(2).CommentsClose CommentsPermalink





`(c) Certification-CommentsClose CommentsPermalink





`(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).CommentsClose CommentsPermalink





`(2) FOREIGN COUNTRY- A foreign country may obtain a certification by the Secretary stating that--CommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(d) Revocation of Certification- The Secretary may, with respect to a foreign facility or foreign country, revoke a certification under subsection (c) if--CommentsClose CommentsPermalink





`(1) food from the foreign facility or foreign country is linked to an outbreak of human illness;CommentsClose CommentsPermalink





`(2) the Secretary determines that the foreign facility or foreign country is no longer meeting the requirements described in subsection (c); orCommentsClose CommentsPermalink





`(3) United States officials are not allowed to conduct such audits and investigations as may be necessary to carry out this section.CommentsClose CommentsPermalink





`(e) Periodic Review- The Secretary shall periodically review certifications under subsection (c) for compliance with the requirements of this section.CommentsClose CommentsPermalink





`(f) Duration of Certification- Each certification under subsection (c) shall be for a period of not more than 5 years.CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(1) inspect foreign facilities to ensure compliance with the food safety standards described in subsection (a); andCommentsClose CommentsPermalink





`(2) consider independent audits, product test data, and other relevant information generated by the facility, importer, or foreign country involved.CommentsClose CommentsPermalink





`(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).CommentsClose CommentsPermalink





`(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).CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink

`SEC. 419. NOTIFICATION AND RECALL.

`(a) Notice to Secretary of Violation-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(1) cease distribution of the food;CommentsClose CommentsPermalink





`(2) notify all persons--CommentsClose CommentsPermalink





`(A) processing, distributing, or otherwise handling the food to immediately cease such activities with respect to the food; orCommentsClose CommentsPermalink





`(B) to which the food has been distributed, transported, or sold, to immediately cease distribution of the food;CommentsClose CommentsPermalink





`(3) recall the food;CommentsClose CommentsPermalink





`(4) in conjunction with the Secretary, provide notice of the finding of the Secretary--CommentsClose CommentsPermalink





`(A) to consumers to whom the food was, or may have been, distributed; andCommentsClose CommentsPermalink





`(B) to State and local public health officials; orCommentsClose CommentsPermalink





`(5) take any combination of the measures described in this subsection, as determined by the Secretary to be appropriate in the circumstances.CommentsClose CommentsPermalink





`(c) Civil and Criminal Penalties-CommentsClose CommentsPermalink





`(1) CIVIL SANCTIONS-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(B) SEPARATE OFFENSE- Each act described in subparagraph (A) and each day during which that act continues shall be considered a separate offense.CommentsClose CommentsPermalink





`(2) OTHER REQUIREMENTS-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(B) AMOUNT OF PENALTY- Subject to paragraph (1)(A), the amount of the civil penalty shall be determined by the Secretary, after considering--CommentsClose CommentsPermalink





`(i) the gravity of the violation;CommentsClose CommentsPermalink





`(ii) the degree of culpability of the person;CommentsClose CommentsPermalink





`(iii) the size and type of the business of the person; andCommentsClose CommentsPermalink





`(iv) any history of prior offenses by the person under this Act.CommentsClose CommentsPermalink





`(C) REVIEW OF ORDER- The order may be reviewed only in accordance with subsection (d).CommentsClose CommentsPermalink





`(3) EXCEPTION- No person shall be subject to the penalties of this subsection--CommentsClose CommentsPermalink





`(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)--CommentsClose CommentsPermalink





`(i) the name, address, and contact information of the person from whom that person purchased or received the food;CommentsClose CommentsPermalink





`(ii) copies of all documents relating to the person from whom that person purchased or received the food; andCommentsClose CommentsPermalink





`(iii) copies of all documents pertaining to the delivery of the food to that person; orCommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(d) Judicial Review-CommentsClose CommentsPermalink





`(1) IN GENERAL- An order assessing a civil penalty under subsection (c) shall be a final order unless the person--CommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(B) simultaneously serves a copy of the petition by certified mail to the Secretary.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(e) Collection Actions for Failure To Pay-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(f) Penalties Paid Into Account- The Secretary--CommentsClose CommentsPermalink





`(1) shall deposit penalties collected under this section in an account in the Treasury; andCommentsClose CommentsPermalink





`(2) may use the funds in the account, without further appropriation or fiscal year limitation--CommentsClose CommentsPermalink





`(A) to carry out enforcement activities under food safety law; orCommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink

`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--CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(A) at the expense of such food establishment; orCommentsClose CommentsPermalink





`(B) in an emergency (as determined by the Secretary), at the expense of the Secretary; andCommentsClose CommentsPermalink





`(2) by order, require, as the Secretary determines to be necessary, the person to immediately--CommentsClose CommentsPermalink





`(A) cease distribution of the food; andCommentsClose CommentsPermalink





`(B) notify all persons--CommentsClose CommentsPermalink





`(i) processing, distributing, or otherwise handling the food to immediately cease such activities with respect to the food; orCommentsClose CommentsPermalink





`(ii) if the food has been distributed, transported, or sold, to immediately cease distribution of the food.CommentsClose CommentsPermalink





`(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)--CommentsClose CommentsPermalink





`(1) to consumers to whom the food was, or may have been, distributed; andCommentsClose CommentsPermalink





`(2) to State and local public health officials.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(1) persons that processed, distributed, or otherwise handled the food; andCommentsClose CommentsPermalink





`(2) persons to which the food has been transported, sold, distributed, or otherwise handled.CommentsClose CommentsPermalink





`(e) Informal Hearings on Orders-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(f) Post-Hearing Recall Orders-CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(A) amend the order to require recall of the food or other appropriate action;CommentsClose CommentsPermalink





`(B) specify a timetable in which the recall shall occur;CommentsClose CommentsPermalink





`(C) require periodic reports to the Secretary describing the progress of the recall; andCommentsClose CommentsPermalink





`(D) provide notice of the recall to consumers to whom the food was, or may have been, distributed.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink