II 110th CONGRESS 1st Session S. 1274 IN THE SENATE OF THE UNITED STATES May 2, 2007 Mr. Durbin introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of food for humans and pets.

1.

Short title

This Act may be cited as the Human and Pet Food Safety Act of 2007.

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:

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.

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.

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.

.

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 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.

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.

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.

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.