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May 2, 2007, 12:00 am ET - Amendment SA 1022 proposed by Senator Durbin.
May 2, 2007, 5:08 pm ET - Durbin Amdt. No. 1022, as Modified

Full Text of this Amendment

SA 1022. Mr. DURBIN (for himself, Mr. ENZI, Mr. KENNEDY, Mr. ALLARD, Mr. KOHL, Ms. CANTWELL, Mr. SCHUMER, Mr. BIDEN, Mr. NELSON of Florida, and Mr. CASEY) proposed an amendment to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; as follows:

At the end of the bill, insert the following:
TITLE __--FOOD SAFETY


SEC. X01. FINDINGS.
(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 animals 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 from a wide variety of countries; and
(C) a shortage of adequate resources for 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.
SEC. X02. 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 title 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 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.--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 adulteration of the pet food supply and outbreaks of illness associated with pet food. In establishing such system, the Secretary shall--
(1) 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;
(2) consult with relevant professional associations and private sector veterinary hospitals; and
(3) work with the Health Alert Network and other notification networks to inform veterinarians and relevant stakeholders during any recall of pet food.
SEC. X03. ENSURING EFFICIENT AND EFFECTIVE COMMUNICATIONS DURING A RECALL.
The Secretary shall, during an ongoing recall of human or pet food--
(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. X04. STATE AND FEDERAL COOPERATION.
(a) In General.--The Secretary shall work with the States in undertaking activities and programs that assist in improving the safety of fresh and processed produced so that State food safety programs involving the safety of fresh and processed produce and activities conducted by the Secretaries function in a coordinated and cost-effective manner. With the assistance provided under subsection (b), the Secretary shall encourage States to--
(1) establish, continue, or strengthen State food safety programs, especially with respect to the regulation of retail commercial food establishments; and
(2) establish procedures and requirements for ensuring that processed produce under the jurisdiction of the State food safety programs is not unsafe for human consumption.
(b) Assistance.--The Secretary may provide to a State, for planning, developing, and implementing such a food safety program--
(1) advisory assistance;
(2) technical assistance, training, and laboratory assistance (including necessary materials and equipment); and
(3) financial and other assistance.
(c) Service Agreements.--The Secretary may, under an agreement entered into with a Federal, State, or local agency, use, on a reimbursable basis or otherwise, the personnel, services, and facilities of the agency to carry out the responsibilities of the agency under this section. An agreement entered into with a State agency under this subsection may provide for training of State employees.
SEC. X05. ADULTERATED FOOD REGISTRY.
(a) Findings.--Congress makes the following findings:
(1) In 1994, Congress passed the Dietary Supplement Health and Education Act (P.L. 103-417) to provide the Food and Drug Administration with the legal framework to ensure that dietary supplements are safe and properly labeled foods.
(2) In 2006, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act (P.L. 109-462) to establish a mandatory reporting system of serious adverse events for non-prescription drugs and dietary supplements sold and consumed in the United States.
(3) The adverse event reporting system created under the Dietary Supplement and Nonprescription Drug Consumer Protection Act will serve as the early warning system for any potential public health issues associated with the use of these food products.
(4) A reliable mechanism to track patterns of adulteration in food would support efforts by the Food and Drug Administration to effectively target limited inspection resources to protect the public health.
(b) In General.--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. ADULTERATED FOOD REGISTRY.
``(a) Definitions.--In this section:
``(1) IMPORTER.--The term `importer', with respect to an article of food, means the person who submitted the notice with respect to such article of food under section 801(m).
``(2) RESPONSIBLE PARTY.--The term `responsible party', with respect to an article of food, means any registered food facility under section 415(a), including those responsible for the manufacturing, processing, packaging or holding of such food for consumption in the United States.
``(3) REPORTABLE ADULTERATED FOOD.--The term `reportable adulterated food' for purposes of this section means a food that is adulterated or--
``(A) presents a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death as defined in section 7.3(m)(1) of title, Code of Federal Regulations (or any successor regulations); or
``(B) meets the threshold established in section 304(h).
``(b) Establishment.--
``(1) IN GENERAL.--Not later than 180 days after the date of enactment of this section, the Secretary shall establish within the Food and Drug Administration an Adulterated Food Registry to which instances of reportable adulterated food may be submitted by the Food and Drug Administration after receipt of reports of adulteration, via an electronic portal, from--
``(A) Federal, State, and local public health officials;
``(B) an importer;
``(C) a responsible party; or
``(D) a consumer or other individual.
``(2) REVIEW BY SECRETARY.--The Secretary shall review and determine the validity of the information submitted under paragraph (1) for the purposes of identifying adulterated food, submitting entries to the Adulterated Food Registry, acting under subsection (c), and exercising other existing food safety authorities under the Act to protect the public health.
``(c) Issuance of an Alert by the Secretary.--
``(1) IN GENERAL.--The Secretary shall issue an alert with respect to an adulterated food if the Adulterated Food Registry shows that the food--
``(A) has been associated with repeated and separate outbreaks of illness or has been repeatedly determined to be adulterated; or
``(B) is a reportable adulterated food.
``(2) SCOPE OF ALERT.--An alert under paragraph (1) may apply to a particular food or to food from a particular producer, manufacturer, shipper, growing area, or country, to the extent that elements in subparagraph (A) or (B) of paragraph (1) are associated with the particular food, producer, manufacturer, shipper, growing area, or country.
``(d) Submission by a Consumer or Other Individual.--A consumer or other individual may submit a report to the Food and Drug Administration using the electronic portal data elements described in subsection (e). Such reports shall be evaluated by the Secretary as specified in subsection (b)(2).
``(e) Notification and Reporting of Adulteration.--
``(1) DETERMINATION BY RESPONSIBLE PARTY OR IMPORTER.--If a responsible party or importer determines that an article of food it produced, processed, manufactured, distributed, or otherwise handled is a reportable adulterated food, the responsible party shall provide the notifications described under paragraph (2).
``(2) NOTIFICATION OF ADULTERATION.--
``(A) IN GENERAL.--Not later than 5 days after a responsible party or importer receives a notification, the responsible party or importer, as applicable, shall review whether the food referenced in the report described in paragraph (1) is a reportable adulterated food.
``(B) NOTIFICATION.--If a determination is made by such responsible party or importer that the food is a reportable adulterated food, such responsible party or importer shall, no later than 5 days after such determination is made, notify other responsible parties directly linked in the supply chain to which and from which the article of reportable adulterated food was transferred.
``(3) SUBMISSION OF REPORTS TO THE FOOD AND DRUG ADMINISTRATION BY A RESPONSIBLE PARTY OR IMPORTER.--The responsible party or importer, as applicable, shall submit a report to the Food and Drug Administration through the electronic portal using the data elements described in subsection (f) not later than 2 days after a responsible party or importer--
``(A) makes a notification under paragraph (2)(B); or
``(B) determines that an article of food it produced, processed, manufactured, distributed, imported, or otherwise handled is a reportable adulterated food, except that if such adulteration was initiated with such responsible party or importer, was detected prior to any transfer of such article of food, and was destroyed, no report is necessary.
``(f) Data Elements in the Registry.--A report submitted to the Food and Drug Administration electronic portal under subsection (e) shall include the following data elements:
``(1) Contact information for the individual or entity submitting the report.
``(2) The date on which an article of food was determined to be adulterated or suspected of being adulterated.
``(3) A description of the article of food including the quantity or amount.
``(4) The extent and nature of the adulteration.
``(5) The disposition of the article.
``(6) Product information typically found on packaging including product codes, use by dates, and names of manufactures or distributors.
``(7) Information about the place of purchase or process by which the consumer or other individual acquired the article of adulterated food.
``(8) In the case of a responsible party or an importer, the elements required for the registration of food facilities under section 415(a).
``(9) The contact information for parties directly linked in the supply chain and notified under subsection (e)(2).
``(10) In the case of an importer, the elements required for the prior notice of imported food shipments under section 801(m).
``(g) Maintenance and Inspection of Records.--The responsible person or importer shall maintain records related to each report received, notification made, and report submitted to the Food and Drug Administration under this section and permit inspection of such records as provided for in section 414. Such records shall also be made available during an inspection under section 704.
``(h) Request for Information.--Section 552 of title 5, United States Code, shall apply to any request for information regarding a record in the Adulterated Food Registry.
``(i) Homeland Security Notification.--If, after receiving a report under subsection (e), the Secretary suspects such food may have been deliberately adulterated, the Secretary shall immediately notify the Secretary of Homeland Security. The Secretary shall make the data in the Adulterated Imported Food Registry available to the Secretary of Homeland Security.''.
(c) Definition.--Section 201(ff) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)) is amended by striking ``section 201(g)'' and inserting ``sections 201(g) and 417''.
(d) Prohibited Acts.--Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended by this Act, is further amended by adding at the end the following:
``(kk) The failure to provide a report as required under section 417(e)(3).
``(ll) The falsification a report as required under section 417(e)(3).''.
(e) Suspected Food Adulteration Regulations.--The Secretary shall, within 180 days of enactment of this Act, promulgate regulations that establish standards and thresholds by which importers and responsible parties shall be required and consumers may be able to, under section 417 of the Federal Food, Drug, and Cosmetic Act (as added by this section)--
(1) report instances of suspected reportable adulteration of food to the Food and Drug Administration for possible inclusion in the Adulterated Food Registry after evaluation of such report; and
(2) notify, in keeping with subsection (e)(2) of such section 417, other responsible parties directly linked in the supply chain, including establishments as defined in section 415(b) of such Act.
(f) Effective Date.--The requirements of section 417(e) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall become effective 180 days after the date of enactment of this Act.
SEC. X06. 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 inspectors are required to improve the Food and Drug Administration's ability to safeguard the food supply of the United States;
(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 with the trading partners of the United States with respect to food safety; and
(4) the Senate should work to develop a comprehensive response to the issue of food safety.
SEC. X07. ANNUAL REPORT TO CONGRESS.
The Secretary 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 regulated by the Food and Drug Administration imported into the United States, aggregated by country and type of food;
(2) a listing of the number of Food and Drug Administration inspectors of imported food products referenced in paragraph (1) and the number of Food and Drug Administration 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 actions used to follow-up on such findings and violations.
SEC. X08. RULE OF CONSTRUCTION.
Nothing in this title (or an amendment made by this title) shall be construed to affect--
(1) the regulation of dietary supplements under the Dietary Supplement Health and Education Act; or
(2) the adverse event reporting system for dietary supplements created under the Dietary Supplement and Nonprescription Drug Consumer Protection Act.
SEC. X09. AUTHORIZATION OF APPROPRIATIONS.
There are authorized to be appropriated to carry out this title (and the amendments made by this title) such sums as may be necessary.



(As printed in the Congressional Record for the Senate on May 2, 2007.)