II 110th CONGRESS 1st Session S. 1776 IN THE SENATE OF THE UNITED STATES July 12, 2007 Mr. Durbin (for himself and Mr. Brown) introduced the following bill; which was read twice and referred to the Committee on Agriculture, Nutrition, and Forestry A BILL To amend the Federal Food, Drug, and Cosmetic Act to establish a user fee program to ensure food safety, and for other purposes.

1.

Short title; findings

(a)

Short title

This Act may be cited as the Imported Food Security Act of 2007. (b)

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 from 2003 to 2007.

2.

User fees regarding inspections of imported food safety

Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) is amended by inserting after section 801 the following:

801A.

User fees regarding food safety

(a)

In General

(1)

Assessment

Beginning in fiscal year 2008, the Secretary shall in accordance with this section assess and collect fees on food imported into the United States. (2)

Purpose of fees

(A)

In general

The purpose of fees under paragraph (1) is to defray the costs of carrying out section 801 with respect to food. Costs referred to in the preceding sentence include increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in carrying out such section. (B)

Allocations by secretary

Of the total fee revenues collected under paragraph (1) for a fiscal year, the Secretary shall reserve and expend amounts in accordance with the following: (i)The Secretary shall reserve not less than 50 percent for carrying out section 801 with respect to food, other than research under section 801(p). In expending the amount so reserved, the Secretary shall give first priority to inspections conducted at ports of entry into the United States and second priority to the implementation of the import certification program under section 805. (ii)The Secretary shall reserve not more than 50 percent for carrying out research under section 801(p). (3)

Amount of fee; collection

A fee under paragraph (1) shall be assessed on each line item of food, as defined by the Secretary by regulation. The amount of the fee shall be based on the number of line items, and may not exceed $20 per line item, notwithstanding subsection (b). The liability for the fee constitutes a personal debt due to the United States, and such liability accrues on the date on which the Secretary approves the food under section 801(c)(1). The Secretary may coordinate with and seek the cooperation of other agencies of the Federal Government regarding the collection of such fees. (b)

Total Fee Revenues

The total fee revenues collected under subsection (a) for a fiscal year shall be the amount appropriated under subsection (f)(3). (c)

Annual fee adjustment

Not later than 60 days after the end of each fiscal year beginning after fiscal year 2008, the Secretary, subject to not exceeding the maximum fee amount specified in subsection (a)(3), shall adjust the amounts that otherwise would under subsection (a) be assessed as fees during the fiscal year in which the adjustment occurs so that the total revenues collected in such fees for such fiscal year equal the amount applicable pursuant to subsection (b) for the fiscal year. (d)

Fee Waiver or Reduction

The Secretary shall grant a waiver from or a reduction of a fee assessed under subsection (a) where the Secretary finds that the fee to be paid will exceed the anticipated present and future costs incurred by the Secretary in carrying out section 801 with respect to food (which finding may be made by the Secretary using standard costs). (e)

Assessment of Fees

(1)

Limitation

Fees may not be assessed under subsection (a) for a fiscal year beginning after fiscal year 2008 unless the amount appropriated for salaries and expenses of the Food and Drug Administration for such fiscal year is equal to or greater than the amount appropriated for salaries and expenses of the Food and Drug Administration for fiscal year 2008 multiplied by the adjustment factor applicable to the fiscal year involved, except that in making determinations under this paragraph for the fiscal years involved there shall be excluded— (A)the amounts appropriated under subsection (f)(3) for the fiscal years involved; and (B)the amounts appropriated under section 736(g) for such fiscal years. (2)

Authority

If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate of the fees, at any time in such fiscal year notwithstanding the provisions of subsection (a)(3) relating to the time at which fees are to be paid. (f)

Crediting and Availability of Fees

(1)

In general

Fees collected for a fiscal year pursuant to subsection (a) shall be credited to the appropriation account for salaries and expenses of the Food and Drug Administration and shall be available in accordance with appropriation Acts until expended without fiscal year limitation. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for carrying out section 801 with respect to food, and the sums are subject to allocations under subsection (a)(2)(B). (2)

Collections and appropriation acts

The fees authorized in subsection (a)— (A)shall be collected in each fiscal year in accordance with subsections (a)(3) and (b); and (B)shall only be collected and available for the purpose specified in subsection (a)(2). (3)

Authorization of appropriations; allocations by secretary

Subject to paragraph (4), there is authorized to be appropriated for fees under this section such sums as may be necessary to carry out the purposes of this section for each of the fiscal years 2008 through 2012. Such appropriated funds may be in addition to any other funds appropriated for such purposes. (4)

Offset

Any amount of fees collected for a fiscal year under subsection (a) that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year. (g)

Collection of Unpaid Fees

In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31, United States Code. (h)

Construction

This section may not be construed as requiring that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in carrying out section 801 with respect to food be reduced to offset the number of officers, employees, and advisory committees so engaged. (i)

Definition of Adjustment Factor

For purposes of this section, the term adjustment factor applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for April of the preceding fiscal year divided by such Index for April 2007.

.

3.

Research on testing techniques for food safety inspections of imported food; priority regarding detection of intentional adulteration

Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the following: (p)

Research on testing techniques for food safety inspections of imported food

(1)

In general

The Secretary shall (directly or through grants or contracts) provide for research on the development of tests and sampling methodologies, for use in inspections of food under this section— (A)whose purpose is to determine whether food is adulterated by reason of being contaminated with microorganisms or pesticide chemicals or related residues; and (B)whose results are available not later than approximately 60 minutes after the administration of the tests. (2)

Priority

In providing for research under paragraph (1), the Secretary shall give priority to conducting research on the development of tests that are suitable for inspections of food at ports of entry into the United States. In providing for research under paragraph (1), the Secretary shall under the preceding sentence give priority to conducting research on the development of tests for detecting the presence in food of the pathogens E. coli, salmonella, cyclospora, cryptosporidium, hepatitis A, or listeria, the presence in or on food of pesticide chemicals and related residues, and the presence in or on food of such other pathogens or substances as the Secretary determines to be appropriate. The Secretary shall establish the goal of developing, by the expiration of the 3-year period beginning on the date of the enactment of the Imported Food Security Act of 2007, tests under paragraph (1) for each of the pathogens and substances receiving priority under the preceding sentence. (3)

Periodic reports

The Secretary shall submit to Congress periodic reports describing the progress that has been made toward the goal referred to in paragraph (1) and describing plans for future research toward the goal. Each of the reports shall provide an estimate by the Secretary of the amount of funds needed to meet such goal, and shall provide a determination by the Secretary of whether there is a need for further research under this subsection. The first such report shall be submitted not later than March 1, 2008, and subsequent reports shall be submitted semiannually after the submission of the first report until the goal is met. (4)

Consultation

The Secretary shall carry out the program of research under paragraph (1) in consultation with the Director of the Centers for Disease Control and Prevention, the Director of the National Institutes of Health, and the Administrator of the Environmental Protection Agency. The Secretary shall with respect to such research coordinate the activities of the Department of Health and Human Services. The Secretary shall in addition consult with the Secretary of Agriculture (acting through the Food Safety and Inspection Service of the Department of Agriculture) in carrying out the program. (5)

Awards to private entities

Of the amounts reserved under section 801A(a)(2)(B)(ii) for a fiscal year for carrying out the program of research under paragraph (1), the Secretary shall make available not less than 50 percent for making awards of grants or contracts to private entities to conduct such research. .

4.

Certification of food imports

(a)

In general

Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) is amended by adding at the end the following:

805.

Certification of food imports

(a)

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 food establishment seeking to import food to the United States shall submit a request for certification to the Secretary. (b)

Certification standard

A foreign government or foreign food establishment 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 food establishment 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. (c)

Certification approval

(1)

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. (2)

Request by foreign food establishment

Prior to granting the certification request of a foreign food establishment, 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. (d)

Limitation

A foreign government or foreign firm 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. (e)

Withdrawal of certification

The Secretary may withdraw certification of any food from a foreign government or foreign firm— (1)if such food is linked to an outbreak of human illness; (2)following an investigation by the Secretary that finds that the foreign government programs and procedures or foreign food establishment is no longer equivalent to the food safety programs and procedures in the United States; or (3)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. (f)

Renewal of certification

The Secretary shall audit foreign governments and foreign food establishments at least every 5 years to ensure the continued compliance with the standards set forth in this section. (g)

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— (1)safe; (2)labeled as required for food produced in the United States; and (3)otherwise meets requirements under this Act. (h)

Enforcement

The Secretary is authorized to— (1)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; (2)deny importation of food from any foreign government or foreign firm that does not consent to an investigation by the Secretary 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 (3)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. (i)

Detention and seizure

Any food imported for consumption in the United States may be detained, seized, or condemned pursuant to section 304. (j)

Definition

For purposes of this section, the term food establishment— (1)means a slaughterhouse, factory, warehouse, or facility owned or operated by a person located in any State that processes food or a facility that holds, stores, or transports food or food ingredients; and (2)does not include a farm, restaurant, other retail food establishment, nonprofit food establishment in which food is prepared for or served directly to the consumer, or fishing vessel (other than a fishing vessel engaged in processing, as that term is defined in section 123.3 of title 21, Code of Federal Regulations).

. (b)

Transitional program

Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall promulgate regulations to establish a transitional food safety import review program, with minimal disruption to commerce, that shall be in effect until the date of implementation of the food import certification program under section 805 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)).