[Congressional Record Volume 153, Number 111 (Thursday, July 12, 2007)]
[Senate]
[Pages S9140-S9143]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DURBIN (for himself and Mr. Brown):
  S. 1776. 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; to the Committee on Agriculture, Nutrition, and Forestry.
  Mr. DURBIN. Mr. President, I rise today to introduce legislation to 
strengthen the ability of the Food and Drug Administration, FDA, to 
ensure the safety of food imported into the U.S.
  The volume of food imports has increased significantly in recent 
years, from $45.6 billion in 2003 to $64 billion in 2006. According to 
the USDA, imported food accounts for 13 percent of the average 
American's diet, including 31 percent of fruits, juices, and nuts; 9.5 
percent of red meat; and 78.6 percent of fish and shellfish.
  This upward trend in imported food has been accompanied by an 
increasing number of health and safety incidents related to imported 
food products. In the past 6 months, we have seen what appears to be 
the intentional contamination of wheat gluten and rice protein 
concentrate with melamine, which is an industrial product that should 
never find its way into food products. In addition, we recently learned 
that a significant volume of imported fish products from China have 
been contaminated with chemicals and residues, including Malachine 
green and Nitrofuren. We have found imported Chinese toothpaste in the 
U.S. that was contaminated with diethylene glycol, which is a toxic 
component used in antifreeze.
  Unfortunately, the FDA currently lacks the resources and authority to 
adequately determine the quality and safety of food imports, inspect an 
adequate volume of imported food, and rapidly detect and respond to 
incidents of contaminated imports. This legislation would take several 
steps to correct these problems.
  First, the bill would impose a fee for the FDA's oversight of 
imported food products. These fees would generate revenues to be used 
for inspections of imported food and critical food safety research. The 
legislation directs the FDA to use some of this funding to perform 
cutting-edge research to develop testing technologies and methods that 
would quickly and accurately detect the presence of pervasive 
contaminants such as E. coli and listeria. The legislation would also 
establish a food importer certification program that would require 
foreign firms and governments to demonstrate that their food safety 
systems are equivalent to ours.
  What has been made clear through the pet food recall and other 
outbreaks of foodborne illnesses is that the FDA is a severely 
underfunded and understaffed agency. Much of the responsibility for 
overseeing and inspecting the safety of imported food rests with the

[[Page S9141]]

FDA. However, due to fairly flat budgets and increasing 
responsibilities, the number of inspectors looking at these shipments 
has actually decreased from more than 3,000 inspectors in 2003 to the 
present level of around 2,700 inspectors.
  The Centers for Disease Control, CDC, estimates that 76 million 
Americans become sick from foodborne illnesses each year. More than 
300,000 are hospitalized and 5,000 die each year. Less than 1.5 percent 
of imported food is inspected by the FDA and the FDA lacks the 
resources and authorities to certify the standards of our trading 
partners. This situation presents an economic, public health, and 
bioterrorism risk to the U.S.
  The FDA office that is responsible for regulating more than $60 
billion of imported food, the Center for Food Safety and Nutrition, 
CFSAN, is also responsible for regulating $417 billion worth of 
domestic food and $59 billion in cosmetics. All of this activity is 
regulated by an office for which the President requested $467 million 
in fiscal year 2008. Only $312 million of that amount would be for 
inspectors. We clearly need to review FDA's funding to make sure that 
it has the resources necessary to safeguard the 80 percent of our food 
supply that it is responsible for regulating. For this reason, a group 
of my colleagues and I sent a letter earlier this year to the 
Agriculture Appropriations Subcommittee, which funds the FDA, asking 
for a significant increase in the level of funding for the FDA foods 
program.
  But imports present a special challenge. It may cost more to ensure 
the safety of food produced in other countries, and the logistical 
challenges are greater. It is important that we supplement the FDA's 
budget with additional funding streams to make sure that it has the 
resources necessary to safeguard our food supply from contaminated 
imports.
  Specifically this legislation would direct the FDA to collect a user 
fee on imported food products, for the administrative review, 
processing, and inspection costs borne by the FDA. The legislation 
would use that funding to bolster FDA's import inspection program, 
which currently inspects less than 1.5 percent of all imports. It would 
also fund critical research into rapid testing technologies for 
detecting foodborne pathogens.
  Lastly, this bill would establish an imported food certification 
program. Today, any country and any company can export food products to 
the United States as long as they inform regulators of the shipment. No 
checks are performed to ensure that the producer has adequate sanitary 
standards. The FDA does not ensure that trading partners have 
equivalent regulatory systems or inspect overseas plants when problems 
arise.
  When the FDA does want to investigate an outbreak, it can be delayed 
by uncooperative foreign governments. For example, during the pet food 
recall, U.S. regulators were delayed three weeks in their request for 
visas to inspect facilities.
  This new program would mark a watershed change in the food import 
safety posture of the U.S. This bill says that if you want a slice of 
the lucrative U.S. market, you have to comply with the same common-
sense standards that apply to U.S. food producers. You have to have 
equivalent food safety systems and processes in place to those of the 
U.S. You need to give U.S. regulators access to your facilities and 
records so they can check your safety record without unnecessary delay. 
In addition, U.S. regulators would have the power to revoke the 
certification of a company or country that fails to comply, and to 
detain products that fail to meet U.S. standards.
  For too long, we have gone without a solid safety standard for 
imported foods. Instead, our regulators jump from alert to alert and 
recall to recall. This legislation would close these loopholes that 
allow dangerous imports into our country and put a solid, proactive 
system in place to protect our food supply.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 1776

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

     SECTION 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 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.

     SEC. 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:


                   ``USER FEES REGARDING FOOD SAFETY

       ``Sec. 801A.  (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

[[Page S9142]]

     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.''.

     SEC. 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.''.

     SEC. 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:

     ``SEC. 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;

[[Page S9143]]

       ``(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)).
                                 ______