II 

110TH CONGRESS 

1ST SESSION S. 1776 

To amend the Federal Food, Drug, and Cosmetic Act to establish a user 

fee program to ensure food safety, and for other purposes. 

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 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; FINDINGS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Imported Food Security Act of 2007’’. 

6 (b) FINDINGS.—Congress finds that— 

7 (1) the safety and integrity of the United 

8 States food supply is vital to the public health, to 


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1 public confidence in the food supply, and to the suc2 cess of the food sector of the Nation’s economy; 

3 (2) illnesses and deaths of individuals and com4 panion pets caused by contaminated food— 

5 (A) have contributed to a loss of public 

6 confidence in food safety; and 

7 (B) have caused significant economic losses 

8 to manufacturers and producers not responsible 

9 for contaminated food items; 

10 (3) the task of preserving the safety of the food 

11 supply of the United States faces tremendous pres12 sures with regard to— 

13 (A) emerging pathogens and other con14 taminants and the ability to detect all forms of 

15 contamination; and 

16 (B) an increasing volume of imported food, 

17 without adequate monitoring and inspection; 

18 (4) the United States is increasing the amount 

19 of food that it imports such that— 

20 (A) from 2003 to the present, the value of 

21 food imports has increased from 

22 $45,600,000,000 to $64,000,000,000; and 

23 (B) imported food accounts for 13 percent 

24 of the average Americans diet including 31 per25 cent of fruits, juices, and nuts, 9.5 percent of 


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1 red meat and 78.6 percent of fish and shellfish; 

2 and 

3 (5) the number of full time equivalent Food and 

4 Drug Administration employees conducting inspec5 tions has decreased from 2003 to 2007. 

6 SEC. 2. USER FEES REGARDING INSPECTIONS OF IM7 PORTED FOOD SAFETY. 

8 Chapter VIII of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 381 et seq.) is amended by inserting 

10 after section 801 the following: 

11 ‘‘USER FEES REGARDING FOOD SAFETY

12 ‘‘SEC. 801A. (a) IN GENERAL.— 

13 ‘‘(1) ASSESSMENT.—Beginning in fiscal year 

14 2008, the Secretary shall in accordance with this 

15 section assess and collect fees on food imported into 

16 the United States. 

17 ‘‘(2) PURPOSE OF FEES.— 

18 ‘‘(A) IN GENERAL.—The purpose of fees 

19 under paragraph (1) is to defray the costs of 

20 carrying out section 801 with respect to food. 

21 Costs referred to in the preceding sentence in22 clude increases in such costs for an additional 

23 number of full-time equivalent positions in the 

24 Department of Health and Human Services to 

25 be engaged in carrying out such section. 


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1 ‘‘(B) ALLOCATIONS BY SECRETARY.—Of 

2 the total fee revenues collected under paragraph 

3 (1) for a fiscal year, the Secretary shall reserve 

4 and expend amounts in accordance with the fol5 lowing: 

6 ‘‘(i) The Secretary shall reserve not 

7 less than 50 percent for carrying out sec8 tion 801 with respect to food, other than 

9 research under section 801(p). In expend10 ing the amount so reserved, the Secretary 

11 shall give first priority to inspections con12 ducted at ports of entry into the United 

13 States and second priority to the imple14 mentation of the import certification pro15 gram under section 805. 

16 ‘‘(ii) The Secretary shall reserve not 

17 more than 50 percent for carrying out re18 search under section 801(p). 

19 ‘‘(3) AMOUNT OF FEE; COLLECTION.—A fee 

20 under paragraph (1) shall be assessed on each line 

21 item of food, as defined by the Secretary by regula22 tion. The amount of the fee shall be based on the 

23 number of line items, and may not exceed $20 per 

24 line item, notwithstanding subsection (b). The liabil25 ity for the fee constitutes a personal debt due to the 


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1 United States, and such liability accrues on the date 

2 on which the Secretary approves the food under sec3 tion 801(c)(1). The Secretary may coordinate with 

4 and seek the cooperation of other agencies of the 

5 Federal Government regarding the collection of such 

6 fees. 

7 ‘‘(b) TOTAL FEE REVENUES.—The total fee revenues 

8 collected under subsection (a) for a fiscal year shall be 

9 the amount appropriated under subsection (f)(3). 

10 ‘‘(c) ANNUAL FEE ADJUSTMENT.—Not later than 60 

11 days after the end of each fiscal year beginning after fiscal 

12 year 2008, the Secretary, subject to not exceeding the 

13 maximum fee amount specified in subsection (a)(3), shall 

14 adjust the amounts that otherwise would under subsection 

15 (a) be assessed as fees during the fiscal year in which the 

16 adjustment occurs so that the total revenues collected in 

17 such fees for such fiscal year equal the amount applicable 

18 pursuant to subsection (b) for the fiscal year. 

19 ‘‘(d) FEE WAIVER OR REDUCTION.—The Secretary 

20 shall grant a waiver from or a reduction of a fee assessed 

21 under subsection (a) where the Secretary finds that the 

22 fee to be paid will exceed the anticipated present and fu23 ture costs incurred by the Secretary in carrying out sec24 tion 801 with respect to food (which finding may be made 

25 by the Secretary using standard costs). 


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1 ‘‘(e) ASSESSMENT OF FEES.— 

2 ‘‘(1) LIMITATION.—Fees may not be assessed 

3 under subsection (a) for a fiscal year beginning after 

4 fiscal year 2008 unless the amount appropriated for 

5 salaries and expenses of the Food and Drug Admin6 istration for such fiscal year is equal to or greater 

7 than the amount appropriated for salaries and ex8 penses of the Food and Drug Administration for fis9 cal year 2008 multiplied by the adjustment factor 

10 applicable to the fiscal year involved, except that in 

11 making determinations under this paragraph for the 

12 fiscal years involved there shall be excluded— 

13 ‘‘(A) the amounts appropriated under sub14 section (f)(3) for the fiscal years involved; and 

15 ‘‘(B) the amounts appropriated under sec16 tion 736(g) for such fiscal years. 

17 ‘‘(2) AUTHORITY.—If the Secretary does not 

18 assess fees under subsection (a) during any portion 

19 of a fiscal year because of paragraph (1) and if at 

20 a later date in such fiscal year the Secretary may as21 sess such fees, the Secretary may assess and collect 

22 such fees, without any modification in the rate of 

23 the fees, at any time in such fiscal year notwith24 standing the provisions of subsection (a)(3) relating 

25 to the time at which fees are to be paid. 


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1 ‘‘(f) CREDITING AND AVAILABILITY OF FEES.— 

2 ‘‘(1) IN GENERAL.—Fees collected for a fiscal 

3 year pursuant to subsection (a) shall be credited to 

4 the appropriation account for salaries and expenses 

5 of the Food and Drug Administration and shall be 

6 available in accordance with appropriation Acts until 

7 expended without fiscal year limitation. Such sums 

8 as may be necessary may be transferred from the 

9 Food and Drug Administration salaries and ex10 penses appropriation account without fiscal year lim11 itation to such appropriation account for salaries 

12 and expenses with such fiscal year limitation. The 

13 sums transferred shall be available solely for car14 rying out section 801 with respect to food, and the 

15 sums are subject to allocations under subsection 

16 (a)(2)(B). 

17 ‘‘(2) COLLECTIONS AND APPROPRIATION

18 ACTS.—The fees authorized in subsection (a)— 

19 ‘‘(A) shall be collected in each fiscal year 

20 in accordance with subsections (a)(3) and (b); 

21 and 

22 ‘‘(B) shall only be collected and available 

23 for the purpose specified in subsection (a)(2). 

24 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS; AL25 LOCATIONS BY SECRETARY.—Subject to paragraph 


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1 (4), there is authorized to be appropriated for fees 

2 under this section such sums as may be necessary to 

3 carry out the purposes of this section for each of the 

4 fiscal years 2008 through 2012. Such appropriated 

5 funds may be in addition to any other funds appro6 priated for such purposes. 

7 ‘‘(4) OFFSET.—Any amount of fees collected 

8 for a fiscal year under subsection (a) that exceeds 

9 the amount of fees specified in appropriation Acts 

10 for such fiscal year shall be credited to the appro11 priation account of the Food and Drug Administra12 tion as provided in paragraph (1), and shall be sub13 tracted from the amount of fees that would other14 wise be authorized to be collected under this section 

15 pursuant to appropriation Acts for a subsequent fis16 cal year. 

17 ‘‘(g) COLLECTION OF UNPAID FEES.—In any case 

18 where the Secretary does not receive payment of a fee as19 sessed under subsection (a) within 30 days after it is due, 

20 such fee shall be treated as a claim of the United States 

21 Government subject to subchapter II of chapter 37 of title 

22 31, United States Code. 

23 ‘‘(h) CONSTRUCTION.—This section may not be con24 strued as requiring that the number of full-time equivalent 

25 positions in the Department of Health and Human ServVerDate Aug 31 2005 23:17 Jul 16, 2007 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1776.IS S1776

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1 ices, for officers, employees, and advisory committees not 

2 engaged in carrying out section 801 with respect to food 

3 be reduced to offset the number of officers, employees, and 

4 advisory committees so engaged. 

5 ‘‘(i) DEFINITION OF ADJUSTMENT FACTOR.—For 

6 purposes of this section, the term ‘adjustment factor’ ap7 plicable to a fiscal year is the Consumer Price Index for 

8 all urban consumers (all items; United States city average) 

9 for April of the preceding fiscal year divided by such Index 

10 for April 2007.’’. 

11 SEC. 3. RESEARCH ON TESTING TECHNIQUES FOR FOOD 

12 SAFETY INSPECTIONS OF IMPORTED FOOD; 

13 PRIORITY REGARDING DETECTION OF INTEN14 TIONAL ADULTERATION. 

15 Section 801 of the Federal Food, Drug, and Cosmetic 

16 Act (21 U.S.C. 381) is amended by adding at the end the 

17 following: 

18 ‘‘(p) RESEARCH ON TESTING TECHNIQUES FOR

19 FOOD SAFETY INSPECTIONS OF IMPORTED FOOD.— 

20 ‘‘(1) IN GENERAL.—The Secretary shall (di21 rectly or through grants or contracts) provide for re22 search on the development of tests and sampling 

23 methodologies, for use in inspections of food under 

24 this section— 


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1 ‘‘(A) whose purpose is to determine wheth2 er food is adulterated by reason of being con3 taminated with microorganisms or pesticide 

4 chemicals or related residues; and 

5 ‘‘(B) whose results are available not later 

6 than approximately 60 minutes after the ad7 ministration of the tests. 

8 ‘‘(2) PRIORITY.—In providing for research 

9 under paragraph (1), the Secretary shall give pri10 ority to conducting research on the development of 

11 tests that are suitable for inspections of food at 

12 ports of entry into the United States. In providing 

13 for research under paragraph (1), the Secretary 

14 shall under the preceding sentence give priority to 

15 conducting research on the development of tests for 

16 detecting the presence in food of the pathogens E. 

17 coli, salmonella, cyclospora, cryptosporidium, hepa18 titis A, or listeria, the presence in or on food of pes19 ticide chemicals and related residues, and the pres20 ence in or on food of such other pathogens or sub21 stances as the Secretary determines to be appro22 priate. The Secretary shall establish the goal of de23 veloping, by the expiration of the 3-year period be24 ginning on the date of the enactment of the Im25 ported Food Security Act of 2007, tests under paraVerDate Aug 31 2005 23:17 Jul 16, 2007 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1776.IS S1776

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1 graph (1) for each of the pathogens and substances 

2 receiving priority under the preceding sentence. 

3 ‘‘(3) PERIODIC REPORTS.—The Secretary shall 

4 submit to Congress periodic reports describing the 

5 progress that has been made toward the goal re6 ferred to in paragraph (1) and describing plans for 

7 future research toward the goal. Each of the reports 

8 shall provide an estimate by the Secretary of the 

9 amount of funds needed to meet such goal, and shall 

10 provide a determination by the Secretary of whether 

11 there is a need for further research under this sub12 section. The first such report shall be submitted not 

13 later than March 1, 2008, and subsequent reports 

14 shall be submitted semiannually after the submission 

15 of the first report until the goal is met. 

16 ‘‘(4) CONSULTATION.—The Secretary shall 

17 carry out the program of research under paragraph 

18 (1) in consultation with the Director of the Centers 

19 for Disease Control and Prevention, the Director of 

20 the National Institutes of Health, and the Adminis21 trator of the Environmental Protection Agency. The 

22 Secretary shall with respect to such research coordi23 nate the activities of the Department of Health and 

24 Human Services. The Secretary shall in addition 

25 consult with the Secretary of Agriculture (acting 


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1 through the Food Safety and Inspection Service of 

2 the Department of Agriculture) in carrying out the 

3 program. 

4 ‘‘(5) AWARDS TO PRIVATE ENTITIES.—Of the 

5 amounts reserved under section 801A(a)(2)(B)(ii) 

6 for a fiscal year for carrying out the program of re7 search under paragraph (1), the Secretary shall 

8 make available not less than 50 percent for making 

9 awards of grants or contracts to private entities to 

10 conduct such research.’’. 

11 SEC. 4. CERTIFICATION OF FOOD IMPORTS. 

12 (a) IN GENERAL.—Chapter VIII of the Federal 

13 Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) 

14 is amended by adding at the end the following: 

15 ‘‘SEC. 805. CERTIFICATION OF FOOD IMPORTS. 

16 ‘‘(a) IN GENERAL.—Not later than 2 years after the 

17 date of enactment of this section, the Secretary shall es18 tablish a system under which a foreign government or for19 eign food establishment seeking to import food to the 

20 United States shall submit a request for certification to 

21 the Secretary. 

22 ‘‘(b) CERTIFICATION STANDARD.—A foreign govern23 ment or foreign food establishment requesting a certifi24 cation to import food to the United States shall dem25 onstrate, in a manner determined appropriate by the SecVerDate Aug 31 2005 23:17 Jul 16, 2007 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S1776.IS S1776

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1 retary, that food produced under the supervision of a for2 eign government or by the foreign food establishment has 

3 met standards for food safety, inspection, labeling, and 

4 consumer protection that are at least equivalent to stand5 ards applicable to food produced in the United States. 

6 ‘‘(c) CERTIFICATION APPROVAL.— 

7 ‘‘(1) REQUEST BY FOREIGN GOVERNMENT.— 

8 Prior to granting the certification request of a for9 eign government, the Secretary shall review, audit, 

10 and certify the food safety program of a requesting 

11 foreign government (including all statutes, regula12 tions, and inspection authority) as at least equiva13 lent to the food safety program in the United States, 

14 as demonstrated by the foreign government. 

15 ‘‘(2) REQUEST BY FOREIGN FOOD ESTABLISH16 MENT.—Prior to granting the certification request of 

17 a foreign food establishment, the Secretary shall cer18 tify, based on an onsite inspection, the food safety 

19 programs and procedures of a requesting foreign 

20 firm as at least equivalent to the food safety pro21 grams and procedures of the United States. 

22 ‘‘(d) LIMITATION.—A foreign government or foreign 

23 firm approved by the Secretary to import food to the 

24 United States under this section shall be certified to exVerDate Aug 31 2005 23:17 Jul 16, 2007 Jkt 059200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S1776.IS S1776

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1 port only the approved food products to the United States 

2 for a period not to exceed 5 years. 

3 ‘‘(e) WITHDRAWAL OF CERTIFICATION.—The Sec4 retary may withdraw certification of any food from a for5 eign government or foreign firm— 

6 ‘‘(1) if such food is linked to an outbreak of 

7 human illness; 

8 ‘‘(2) following an investigation by the Secretary 

9 that finds that the foreign government programs 

10 and procedures or foreign food establishment is no 

11 longer equivalent to the food safety programs and 

12 procedures in the United States; or 

13 ‘‘(3) following a refusal to allow United States 

14 officials to conduct such audits and investigations as 

15 may be necessary to fulfill the requirements under 

16 this section. 

17 ‘‘(f) RENEWAL OF CERTIFICATION.—The Secretary 

18 shall audit foreign governments and foreign food establish19 ments at least every 5 years to ensure the continued com20 pliance with the standards set forth in this section. 

21 ‘‘(g) REQUIRED ROUTINE INSPECTION.—The Sec22 retary shall routinely inspect food and food animals (via 

23 a physical examination) before it enters the United States 

24 to ensure that it is— 

25 ‘‘(1) safe; 


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1 ‘‘(2) labeled as required for food produced in 

2 the United States; and 

3 ‘‘(3) otherwise meets requirements under this 

4 Act. 

5 ‘‘(h) ENFORCEMENT.—The Secretary is authorized 

6 to— 

7 ‘‘(1) deny importation of food from any foreign 

8 government that does not permit United States offi9 cials to enter the foreign country to conduct such 

10 audits and inspections as may be necessary to fulfill 

11 the requirements under this section; 

12 ‘‘(2) deny importation of food from any foreign 

13 government or foreign firm that does not consent to 

14 an investigation by the Secretary when food from 

15 that foreign country or foreign firm is linked to a 

16 food-borne illness outbreak or is otherwise found to 

17 be adulterated or mislabeled; and 

18 ‘‘(3) promulgate rules and regulations to carry 

19 out the purposes of this section, including setting 

20 terms and conditions for the destruction of products 

21 that fail to meet the standards of this Act. 

22 ‘‘(i) DETENTION AND SEIZURE.—Any food imported 

23 for consumption in the United States may be detained, 

24 seized, or condemned pursuant to section 304. 


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1 ‘‘(j) DEFINITION.—For purposes of this section, the 

2 term ‘food establishment’— 

3 ‘‘(1) means a slaughterhouse, factory, ware4 house, or facility owned or operated by a person lo5 cated in any State that processes food or a facility 

6 that holds, stores, or transports food or food ingredi7 ents; and 

8 ‘‘(2) does not include a farm, restaurant, other 

9 retail food establishment, nonprofit food establish10 ment in which food is prepared for or served directly 

11 to the consumer, or fishing vessel (other than a fish12 ing vessel engaged in processing, as that term is de13 fined in section 123.3 of title 21, Code of Federal 

14 Regulations).’’. 

15 (b) TRANSITIONAL PROGRAM.—Not later than 180 

16 days after the date of enactment of this Act, the Secretary 

17 of Health and Human Services shall promulgate regula18 tions to establish a transitional food safety import review 

19 program, with minimal disruption to commerce, that shall 

20 be in effect until the date of implementation of the food 

21 import certification program under section 805 of the 

22 Federal Food, Drug, and Cosmetic Act (as added by sub23 section (a)). 

Æ 


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