[Congressional Record Volume 146, Number 69 (Wednesday, June 7, 2000)]
[Senate]
[Pages S4685-S4690]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Ms. MIKULSKI (for herself, Mr. Kennedy, and Mr. Durbin):
  S. 2692. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
improve safety of imported products, and for other purposes; to the 
Committee on Health Education, Labor, and Pensions.


imported products safety improvement and disease prevention act of 2000

  Ms. MIKULSKI. Mr. President, I rise today to reintroduce the 
``Imported Products Safety Improvement and Disease Prevention Act of 
2000.'' I am proud to be the sponsor of this important legislation 
which guarantees the improved safety of imported foods, and I have high 
hopes that we will act on it this year.

  The health of Americans is not something to take chances with. It is 
important that we make food safety a top priority. Every person should 
have the confidence that their food is fit to eat. We should be 
confident that imported food is as safe as food produced in this 
country. Cars can't be imported unless they meet U.S. safety 
requirements. Prescription drugs can't be imported unless they meet FDA 
standards. You shouldn't be able to import food that isn't up to U.S. 
standards, either.
  We import increasing quantities of fresh fruits and vegetables, 
seafood, and many other foods. In the past seven years, the amount of 
food imported into the U.S. has more than doubled. Out of all the 
produce we eat, 40% of it is imported. Our food supply has gone global, 
so we need to have global food safety.
  The impact of unsafe food is staggering. There have been several 
frightening examples of food poisoning incidents in the U.S. When 
Michigan schoolchildren were contaminated with Hepatitis A from 
imported strawberries in 1997, Americans were put on alert. Thousands 
of cases of cyclospora infection from imported raspberries--resulting 
in severe, prolonged diarrhea, weight loss, vomiting, chills and 
fatigue were also reported that year. Imported cantaloupe eaten in 
Maryland sickened 25 people. As much as $663 million was spent on food 
borne illness in Maryland alone. Overall, as many as 33 million people 
per year become ill and over 9000 die as a result of food borne 
illness. It is our children and our seniors who suffer the most. Most 
of the food-related deaths occur in these two populations.
  These incidents have scared us and have jump-started the efforts to 
do more to protect our nation's food supply. Now, I believe in free 
trade, but I also believe in fair trade. FDA's current system of 
testing import samples at ports of entry does not protect Americans. It 
is ineffective and resource-intensive. Less than 2 percent of imported 
food is being inspected under the current system. At the same time, the 
quantity of the imported foods continues to increase.
  What this law does is simple: It improves food safety and aims at 
preventing food borne illness of all imported foods regulated by the 
FDA. This bill takes a long overdue, big first step.
  First, it requires that FDA make equivalence determinations on 
imported food. This was developed with the FDA by Senator Kennedy and 
myself in consultation with the consumer groups.
  Today, FDA has no authority to protect Americans against imported 
food that is unsafe until it is too late. According to the GAO, the FDA 
lacks the authority to require that food coming into the U.S. is 
produced, prepared, packed or held under conditions that provide the 
same level of food safety protection as those in the U.S. This means 
that currently, food offered for import to the U.S., can be imported 
under any conditions, even if those conditions are unsanitary. The 
Imported Products Safety Improvement and Disease Prevention Act of 2000 
will allow FDA to look at the production at its source. This means that 
FDA will be able to take preventive measures. FDA will be able to be 
proactive, rather than just reactive.
  That means that when you pack your childrens' lunches for school or 
sit down at the dinner table, you can rest assured that your food will 
be safe. Whether your strawberries were grown in a foreign country or 
on the Eastern Shore, in Maryland, those strawberries will be held to 
the same standard. You won't have to worry or wonder where your food is 
coming from. You won't have to worry that your children or families are 
going to get sick. You will know that the food coming into this country 
will be subject to equivalent standards.
  Second, this bill contains strong enforcement measures. Last year, 
the Permanent Subcommittee on Investigations, under the leadership of 
Senator Sue Collins, held numerous hearings on the safety of imported 
food. These enforcement measures are largely a product of those facts 
uncovered during those hearings.
  Finally, this bill covers emergency situations by allowing FDA to ban 
imported food that has been connected to outbreaks of food borne 
illness. When our children, parents and communities are getting 
seriously sick, the Secretary of Health and Human Services can 
immediately issue an emergency ban. We don't have to wait till someone 
else gets seriously sick or dies. We no longer have to go through the 
current bureaucratic mechanism that is inefficient and resource 
intensive. We can stop the food today, to protect our citizens.
  My goal is to strengthen the food supply, whatever the source of the 
food may be. This bill won't create trade barriers. It just calls for 
free trade of safe food. It calls for international concern and 
consensus on guaranteeing standards for public health.
  This bill is important because it will save lives and makes for a 
safer world. Everyone should have security in knowing that the food 
they eat is fit to eat. I look forward to working on a bipartisan basis 
to enact this legislation. I pledge my commitment to fight for ways to 
make America's food supply safer. This bill is an important step in 
that direction.
  Mr. President, I ask unanimous consent that the text of the bill and 
a summary be added to the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

[[Page S4686]]

                                S. 2692

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

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Imported Products Safety 
     Improvement and Disease Prevention Act of 2000''.

       TITLE I--IMPROVEMENTS TO THE PRODUCT SAFETY IMPORT SYSTEM

     SEC. 101. EQUIVALENCE AUTHORITY TO PROTECT THE PUBLIC HEALTH 
                   FROM CONTAMINATED IMPORTED PRODUCTS.

       (a) Equivalence Determinations, and Measures, Systems, and 
     Conditions To Achieve Public Health Protection.--Section 801 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) 
     is amended--
       (1) by redesignating subsections (d), (e), and (f) as 
     subsections (f), (g), and (h), respectively; and
       (2) by inserting after subsection (c) the following:
       ``(d)(1) Subject to paragraphs (2) and (3), any covered 
     product offered for import into the United States shall be 
     prepared (including produced), packed, and held under a 
     system or conditions, or subject to measures, that meet the 
     requirements of this Act or that have been determined by the 
     Secretary to be equivalent to a system, conditions, or 
     measures for such covered product in the United States and to 
     achieve the level of public health protection for such 
     covered product prepared, packed, and held in the United 
     States. Consistent with section 492 of the Trade Agreements 
     Act of 1979 (19 U.S.C. 2578a), the Secretary shall make, 
     where appropriate, equivalence determinations described in 
     that section relating to sanitary or phytosanitary measures 
     (including systems and conditions) that apply to the 
     preparation, packing, and holding of covered products offered 
     for import into the United States.
       ``(2) In carrying out this subsection, the Secretary shall 
     conduct systematic evaluations of the systems, conditions, 
     and measures in foreign countries that apply to the 
     preparation, packing, and holding of covered products offered 
     for import into the United States.
       ``(3) The Secretary shall develop a plan for the 
     implementation of the authority under this subsection within 
     2 years after the date of enactment of the Imported Products 
     Safety Improvement and Disease Prevention Act of 2000. In 
     developing the plan, the Secretary shall provide an 
     opportunity for, and take into consideration, public comment 
     on a proposed plan.''.
       (b) General Authority.--Section 801 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 381), as amended in 
     subsection (a), is further amended by inserting after 
     subsection (d) the following:
       ``(e)(1)(A) The Secretary shall establish a system, for use 
     by the Secretary of the Treasury, to deny the entry of any 
     covered product offered for import into the United States if 
     the Secretary of Health and Human Services makes and 
     publishes--
       ``(i) a written determination that the covered product--
       ``(I) has been associated with repeated and separate 
     outbreaks of disease borne in a covered product or has been 
     repeatedly determined by the Secretary to be adulterated 
     within the meaning of section 402;
       ``(II) presents a reasonable probability of causing 
     significant adverse health consequences or death; and
       ``(III) is likely, without systemic intervention or 
     changes, to cause disease or be adulterated again; or
       ``(ii) an emergency written determination that the covered 
     product has been strongly associated with a single outbreak 
     of disease borne in a covered product that has caused serious 
     adverse health consequences or death.
       ``(B)(i) The Secretary shall make a determination described 
     in subparagraph (A) with respect to--
       ``(I) a covered product from a specific producer, 
     manufacturer, or shipper; or
       ``(II) a covered product from a specific growing area or 
     country;
     that meets the criteria described in subparagraph (A).
       ``(ii) Only the covered product from the specific producer, 
     manufacturer, shipper, growing area, or country for which the 
     Secretary makes the determination shall be subject to denial 
     of entry under this subsection.
       ``(C) The denial of entry of any covered product under this 
     paragraph shall be done in a manner consistent with 
     bilateral, regional, and multilateral trade agreements and 
     the rights and obligations of the United States under the 
     agreements.
       ``(D)(i) Before making any written determination under 
     subparagraph (A)(i), the Secretary shall consider written 
     comments, on a proposed determination, made by any party 
     affected by the proposed determination and any remedial 
     actions taken to address the findings made in the proposed 
     determination. In making the written determination, the 
     Secretary may modify or rescind the proposed determination in 
     accordance with such comments.
       ``(ii)(I) The Secretary may immediately issue an emergency 
     written determination under subparagraph (A)(ii) without 
     first considering comments on a proposed determination.
       ``(II) Within 30 days after the issuance of the emergency 
     determination, the Secretary shall consider written comments 
     on the determination that are made by a party described in 
     clause (i) and received within the 30-day period. The 
     Secretary may affirm, modify, or rescind the emergency 
     determination in accordance with the comments.
       ``(III) The emergency determination shall be in effect--
       ``(aa) for the 30-day period; or
       ``(bb) if the Secretary affirms or modifies the 
     determination, until the Secretary rescinds the 
     determination.
       ``(2)(A) The covered product initially denied entry under 
     paragraph (1) may be imported into the United States if the 
     Secretary finds that--
       ``(i) the written determination made under paragraph (1) no 
     longer justifies the denial of entry of the covered product; 
     or
       ``(ii) evidence of remedial action submitted from the 
     producer, manufacturer, shipper, specific growing area, or 
     country for which the Secretary made the written 
     determination under paragraph (1) addresses the 
     determination.
       ``(B)(i) The Secretary shall take action on evidence 
     submitted under subparagraph (A)(ii) within 90 days after the 
     date of the submission of the evidence.
       ``(ii) The Secretary's action may include--
       ``(I) lifting the denial of entry of the covered product; 
     or
       ``(II) continuing to deny entry of the covered product 
     while requesting additional information or specific remedial 
     action from the producer, manufacturer, shipper, specific 
     growing area, or country.
       ``(iii) If the Secretary does not take action on evidence 
     submitted under subparagraph (A)(ii) within 90 days after the 
     date of submission, effective on the 91st day after the date 
     of submission, the covered product initially denied entry 
     under paragraph (1) may be imported into the United States.
       ``(3) The Secretary shall by regulation establish criteria 
     and procedures for the system described in paragraph (1). The 
     Secretary may by regulation modify those criteria and 
     procedures, as the Secretary determines appropriate.''.
       (c) Technical and Conforming Amendments.--
       (1) Section 351(h) of the Public Health Service Act (42 
     U.S.C. 262(h)) is amended by striking ``section 801(e)(1) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(e))'' 
     and inserting ``section 801(g)(1) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 381(g)(1))''.
       (2) Section 301 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 331) is amended--
       (A) in paragraph (t), by striking ``section 801(d)(1)'' and 
     inserting ``section 801(f)(1)''; and
       (B) in paragraph (w)--
       (i) by striking ``sections 801(d)(3)(A) and 801(d)(3)(B)'' 
     and inserting ``subparagraphs (A) and (B) of section 
     801(f)(3)'';
       (ii) except as provided in clause (i), by striking 
     ``section 801(d)(3)'' each place it appears and inserting 
     ``section 801(f)(3)''; and
       (iii) by striking ``section 801(e)'' and inserting 
     ``section 801(g)''.
       (3) Section 303(b)(1)(A) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 333(b)(1)(A)) is amended by striking 
     ``section 801(d)(1)'' and inserting ``section 801(f)(1)''.
       (4) Section 304(d)(1) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 334(d)(1)) is amended--
       (A) by striking ``section 801(e)(1)'' and inserting 
     ``section 801(g)(1)''; and
       (B) except as provided in subparagraph (A), by striking 
     ``section 801(e)'' each place it appears and inserting 
     ``section 801(g)''.
       (5) Section 801 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 381) is amended--
       (A) in subsection (a), in the third sentence, by striking 
     ``subsection (b) of this section'' and inserting ``subsection 
     (b) or subsection (e)(2)(A) (in the case of a covered product 
     described in that subsection)'';
       (B) in paragraph (3)(A) of subsection (f), as redesignated 
     in subsection (a), by striking ``section 801(e) or 802'' and 
     inserting ``subsection (g), section 802,''; and
       (C) in paragraph (1) of subsection (h), as redesignated in 
     subsection (a), by striking ``subsection (e)'' and inserting 
     ``subsection (g)''.
       (6) Section 802 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 382) is amended--
       (A) in subsection (a)(2)(C), by striking ``section 
     801(e)(2)'' and inserting ``section 801(g)(2)'';
       (B) in subsection (f)(3), by striking ``section 801(e)(1)'' 
     and inserting ``section 801(g)(1)''; and
       (C) in subsection (i), by striking ``section 801(e)(1)'' 
     and inserting ``section 801(g)(1)''.

     SEC. 102. PROHIBITION AGAINST THE DISTRIBUTION OF CERTAIN 
                   PRODUCTS.

       (a) Adulterated Products.--Section 402 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 342) is amended by adding 
     at the end the following:
       ``(h)(1) If--
       ``(A) it is a covered product being imported or offered for 
     import into the United States;
       ``(B) the covered product has been designated by the 
     Secretary for sampling, examination, or review for the 
     purpose of determining whether the covered product is in 
     compliance with this Act;
       ``(C) the Secretary requires, under section 801(a)(2)(B), 
     that the covered product not be distributed until the 
     Secretary authorizes the distribution of the covered product; 
     and
       ``(D) the covered product is distributed before the 
     Secretary authorizes the distribution.

[[Page S4687]]

       ``(2) In this paragraph, the term `distributed', used with 
     respect to a covered product, means--
       ``(A) moved for the purpose of selling the covered product, 
     offering the covered product for sale, or delivering the 
     covered product for the purpose of selling the covered 
     product or offering the covered product for sale; or
       ``(B) delivered contrary to any bond requirement.''.
       (b) Prohibition.--Section 801(a) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 381(a)) is amended--
       (1) in the third sentence, by redesignating paragraphs (1) 
     through (3) as subparagraphs (A) through (C), respectively;
       (2) by striking ``(a) The'' and inserting ``(a)(1) The'';
       (3) in the last sentence, by striking ``Clause (2)'' and 
     inserting ``Subparagraph (B)'';
       (4) by moving the fourth sentence to the end;
       (5) in the sentence so moved, by striking ``The Secretary'' 
     and inserting the following:
       ``(2)(A) The Secretary''; and
       (6) by adding at the end the following:
       ``(B) The Secretary of Health and Human Services may 
     require that a covered product being imported or offered for 
     import into the United States not be distributed until the 
     Secretary authorizes distribution of the covered product.''.

     SEC. 103. REQUIREMENT OF SECURE STORAGE OF CERTAIN IMPORTED 
                   PRODUCTS.

       (a) Adulterated Products.--Section 402 of the Federal Food, 
     Drug, and Cosmetic Act, as amended in section 102(a), is 
     further amended by adding at the end the following:
       ``(i) If--
       ``(1) it is a covered product being imported or offered for 
     import into the United States;
       ``(2) the Secretary requires, under section 801(a)(2)(C), 
     that the covered product be held in a secure storage facility 
     until the Secretary authorizes distribution of the covered 
     product; and
       ``(3) the covered product is not held in a secure storage 
     facility as described in section 801(a)(2)(C) until the 
     Secretary authorizes the distribution.''.
       (b) Requirement.--Section 801(a)(2) of the Federal Food, 
     Drug, and Cosmetic Act, as amended in section 102(b), is 
     further amended by adding at the end the following:
       ``(C)(i) The Secretary of Health and Human Services may 
     require that a covered product that is being imported or 
     offered for import into the United States be held, at the 
     expense of the owner or consignee of the covered product, in 
     a secure storage facility until the Secretary authorizes 
     distribution of the covered product, if the Secretary makes 
     the determination that the covered product is--
       ``(I) being imported or offered for import into the United 
     States by a person described in clause (ii); or
       ``(II) owned by or consigned to a person described in 
     clause (ii).
       ``(ii) An importer, owner, or consignee referred to in 
     subclause (I) or (II) of clause (i) is a person against whom 
     the Secretary of the Treasury has assessed liquidated damages 
     not less than twice under subsection (b) for failure to 
     redeliver, at the request of the Secretary of the Treasury, a 
     covered product subject to a bond under subsection (b).''.

     SEC. 104. REQUIREMENT OF ADMINISTRATIVE DESTRUCTION OF 
                   CERTAIN IMPORTED PRODUCTS.

       (a) Adulterated Products.--Section 402 of the Federal Food, 
     Drug, and Cosmetic Act, as amended in section 103(a), is 
     further amended by adding at the end the following:
       ``(j) Notwithstanding subsections (a)(2)(A) and (b) of 
     section 801, if--
       ``(1) it is a covered product being imported or offered for 
     import into the United States;
       ``(2) the covered product presents a reasonable probability 
     of causing significant adverse health consequences or death;
       ``(3) the Secretary, after the covered product has been 
     refused admission under section 801(a), requires under 
     section 801(a)(2)(D) that the covered product be destroyed; 
     and
       ``(4) the owner or consignee of the covered product fails 
     to comply with that destruction requirement.''.
       (b) Requirement.--Section 801(a)(2) of the Federal Food, 
     Drug, and Cosmetic Act, as amended in section 103(b), is 
     further amended by adding at the end the following:
       ``(D) The Secretary of Health and Human Services may 
     require destruction, at the expense of the owner or 
     consignee, of a covered product imported or offered for 
     import into the United States that presents a reasonable 
     probability of causing significant adverse health 
     consequences or death.''.

     SEC. 105. PROHIBITION AGAINST PORT SHOPPING.

       Section 402 of the Federal Food, Drug, and Cosmetic Act, as 
     amended in section 104(a), is further amended by adding at 
     the end the following:
       ``(k) If it is a covered product being imported or offered 
     for import into the United States, and the covered product 
     previously has been refused admission under section 801(a), 
     unless the person reoffering the article affirmatively 
     establishes, at the expense of the owner or consignee of the 
     article, that the article complies with the applicable 
     requirements of this Act, as determined by the Secretary.''.

     SEC. 106. PROHIBITION OF IMPORTS BY DEBARRED PERSONS.

       Section 402 of the Federal Food, Drug, and Cosmetic Act, as 
     amended in section 105, is further amended by adding at the 
     end the following:
       ``(l) If it is a covered product being imported or offered 
     for import into the United States by a person debarred under 
     section 306(b)(4).''.

     SEC. 107. AUTHORITY TO MARK REFUSED ARTICLES.

       (a) Misbranded Products.--Section 403 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding 
     at the end the following:
       ``(t) If--
       ``(1) it has been refused admission under section 801(a);
       ``(2) the covered product has not been required to be 
     destroyed under subparagraph (A) or (B) of section 801(a)(2); 
     and
       ``(3) the packaging of the covered product does not bear a 
     label or labeling described in section 801(a)(2)(E).''.
       (b) Requirement.--Section 801(a)(2) of the Federal Food, 
     Drug, and Cosmetic Act, as amended in section 104(b), is 
     further amended by adding at the end the following:
       ``(E) The Secretary of Health and Human Services may 
     require the owner or consignee of a covered product that has 
     been refused admission under paragraph (1), and has not been 
     required to be destroyed under subparagraph (A) or (B), to 
     affix to the packaging of the covered product a label or 
     labeling that--
       ``(i) clearly and conspicuously bears the following 
     statement: `United States: Refused Entry.';
       ``(ii) is affixed to the packaging until the covered 
     product is brought into compliance with this Act; and
       ``(iii) has been provided at the expense of the owner or 
     consignee of the covered product.''.

     SEC. 108. EXPORT OF REFUSED ARTICLES.

       Paragraph (2)(A) of section 801(a) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 381(a)), as designated in 
     section 102(b), is amended by striking ``ninety days'' and 
     inserting ``30 days''.

     SEC. 109. COLLECTION AND ANALYSIS OF SAMPLES OF PRODUCT 
                   IMPORTS.

       Section 801 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 381), as amended in section 101(a), is further amended 
     by adding at the end the following:
       ``(i) The Secretary may issue regulations or guidance as 
     necessary to govern the collection and analysis by entities 
     other than the Food and Drug Administration of samples of a 
     covered product imported or offered for import into the 
     United States to ensure the integrity of the samples 
     collected and the validity of the analytical results.''.

     SEC. 110. DEFINITION.

       Section 201 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 321) is amended by adding at the end the following:
       ``(kk) The term `covered product' means an article that is 
     described in subparagraph (1), (2), or (3) of paragraph (f) 
     and that is not a dietary supplement. The term shall not 
     include an article to the extent that the Secretary of 
     Agriculture exercises inspection authority over the article 
     at the time of import into the United States.''.

TITLE II--ENFORCEMENT AND PENALTIES FOR IMPORTING CONTAMINATED PRODUCTS

     SEC. 201. ENHANCED BONDING REQUIREMENTS FOR PRIOR INVOLVEMENT 
                   IN IMPORTING ADULTERATED OR MISBRANDED 
                   PRODUCTS.

       Section 801(b) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 381(b)) is amended--
       (1) by inserting ``(1)'' after ``(b)''; and
       (2) by adding at the end the following:
       ``(2)(A) The Secretary of the Treasury, acting through the 
     Commissioner of Customs, shall issue regulations that 
     establish a rate for a bond required to be executed under 
     paragraph (1) for a covered product if an owner, consignee, 
     or importer of the covered product has committed a covered 
     violation.
       ``(B) The regulations shall require the owner or consignee 
     to execute such a bond--
       ``(i) at twice the usual rate; or
       ``(ii) if the owner, consignee, or importer has committed 
     more than 1 covered violation, at a rate that increases with 
     the number of covered violations committed, as determined in 
     accordance with a sliding scale established in the 
     regulations.
       ``(C) In this paragraph:
       ``(i) The term `committed' means been convicted of, or 
     found liable for, a violation by an appropriate court or 
     administrative officer.
       ``(ii) The term `covered violation' means a violation 
     relating to--
       ``(I) importing or offering for import into the United 
     States--
       ``(aa) a covered product during a period of debarment under 
     section 306(b)(4);
       ``(bb) a covered product that is adulterated within the 
     meaning of paragraph (h), (i), (j), (k), or (l) of section 
     402; or
       ``(cc) a covered product that is misbranded within the 
     meaning of section 403(t); or
       ``(II) making a false or misleading statement in conduct 
     relating to the import or offering for import of a covered 
     product into the United States.
       ``(iii) The term `usual rate', used with respect to a bond, 
     means the rate that would be required under paragraph (1) for 
     the bond by a person who has not committed a covered 
     violation.''.

     SEC. 202. DEBARMENT OF REPEAT OFFENDERS AND SERIOUS 
                   OFFENDERS.

       (a) In General.--Section 306(b) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 335a(b)) is amended--

[[Page S4688]]

       (1)  in  paragraph  (1),  in  the  paragraph  heading,  by  
     striking  ``In  general.--''  and  inserting  ``Debarment  
     for  violations  relating  to  drugs.--'';
       (2) in paragraph (2), in the paragraph heading, by striking 
     ``Persons subject to permissive debarment.--'' and inserting 
     ``Persons subject to permissive debarment for violations 
     relating to drugs.--'';
       (3)  in  paragraph  (3),  in  the  paragraph  heading,  by  
     striking  ``Stay  of  certain  orders.--''  and  inserting  
     ``Stay  of  certain  orders  relating  to  debarment  for  
     violations  relating  to  drugs.--'';  and
       (4) by adding at the end the following:
       ``(4) Debarment for violations relating to product 
     imports.--
       ``(A) In general.--The Secretary may debar a person from 
     importing a covered product or offering a covered product for 
     import into the United States, if--
       ``(i) the Secretary finds that the person has been 
     convicted for conduct that is a felony under Federal law and 
     relates to the importation or offering for importation of any 
     covered product into the United States; or
       ``(ii) the Secretary makes a written determination that the 
     person has repeatedly or deliberately imported or offered for 
     import into the United States a covered product adulterated 
     within the meaning of paragraph (h), (i), (j), or (k) of 
     section 402, or misbranded within the meaning of section 
     403(t).
       ``(B) Impact.--On debarring a person under subparagraph 
     (A), the Secretary shall provide notice of the debarment to 
     the Secretary of the Treasury, who shall deny entry of a 
     covered product offered for import by the person.''.
       (b) Technical and Conforming Amendments.--
       (1) In general.--Section 306 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 335a) is amended--
       (A) in subsection (c)--
       (i) in paragraph (1)--

       (I) in subparagraph (B), by striking ``, and'' at the end 
     and inserting a comma;
       (II) by redesignating subparagraph (C) as subparagraph (D); 
     and
       (III) by inserting after subparagraph (B) the following:

       ``(C) shall, during the period of a debarment under 
     subsection (b)(4), prohibit the debarred person from 
     importing a covered product or offering a covered product for 
     import into the United States, and'';
       (ii) in paragraph (2)(A), by inserting after clause (iii) 
     the following:
       ``(iv) The period of debarment of any person under 
     subsection (b)(4) shall be not less than 1 year.''; and
       (iii) in paragraph (3)--

       (I) in subparagraph (C)--

       (aa) by striking ``suspect drugs'' and inserting ``suspect 
     drugs or covered products''; and
       (bb) by striking ``fraudulently obtained'' and inserting 
     ``fraudulently obtained or on a covered product wrongfully 
     imported into the United States''; and

       (II) in subparagraph (E), by inserting ``in the case of a 
     debarment relating to a drug,'' after ``(E)'';

       (B) in subsection (d)--
       (i) in paragraph (3)--

       (I) in subparagraph (A)--

       (aa) in clause (i), by striking ``or (b)(2)(A)'' and 
     inserting ``or paragraph (2)(A) or (4) of subsection (b)''; 
     and
       (bb) in clause (ii)(II), by inserting ``in the case of a 
     debarment relating to a drug,'' after ``(II)''; and

       (II) in subparagraph (B)--

       (aa) in clause (i), by striking ``or clause (i), (ii), 
     (iii) or (iv) of subsection (b)(2)(B)'' and inserting ``, 
     clause (i), (ii), (iii), or (iv) of subsection (b)(2)(B), or 
     subsection (b)(4)''; and
       (bb) in clause (ii), by striking ``subsection (b)(2)(B)'' 
     and inserting ``paragraph (2)(B) or (4) of subsection (b)''; 
     and
       (ii) in paragraph (4)--

       (I) in subparagraph (A), by striking ``(a)(2)'' and 
     inserting ``(a)(2) or (b)(4)'';
       (II) in subparagraph (B)--

       (aa) in clause (ii), by striking ``involving the 
     development or approval of any drug subject to section 505'' 
     and inserting ``involving, as appropriate, the development or 
     approval of any drug subject to section 505 or the 
     importation of any covered product''; and
       (bb) in clause (iv), by striking ``drug'' each place it 
     appears and inserting ``drug or covered product''; and

       (III) in subparagraph (D), in the matter following clause 
     (ii), by inserting ``, in the case of a debarment relating to 
     a drug,'' before ``protects''; and

       (C) in subsection (l)(2), in the second sentence, by 
     striking ``(b)(2)(B)'' and inserting ``(b)(2)(B), subsection 
     (b)(4),''.
       (2) Civil penalties.--Paragraphs (6) and (7) of section 
     307(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     335b(a)) are amended by striking ``306'' and inserting ``306 
     (except section 306(b)(4))''.

     SEC. 203. INCREASED ENFORCEMENT TO IMPROVE THE SAFETY OF 
                   IMPORTED PRODUCTS.

       Subchapter A of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at 
     the end the following:

     ``SEC. 712. POSITIONS TO IMPROVE THE SAFETY OF IMPORTED 
                   PRODUCTS.

       ``There is authorized to be appropriated such sums as may 
     be necessary for each of fiscal years 2001 through 2003 to 
     enable the Commissioner, in carrying out chapters IV and 
     VIII, to decrease the health risks associated with imported 
     covered products through the creation of additional 
     employment positions for laboratory, inspection, and 
     compliance personnel.''.

 TITLE III--IMPROVEMENTS TO PUBLIC HEALTH INFRASTRUCTURE AND AWARENESS

     SEC. 301. IMPROVEMENTS.

       Title II of the Public Health Service Act (42 U.S.C. 202 et 
     seq.) is amended by adding at the end the following:

          ``PART C--PUBLIC HEALTH INFRASTRUCTURE AND AWARENESS

     ``SEC. 251. DEFINITIONS.

       ``In this part:
       ``(1) Covered product.--The term `covered product' has the 
     meaning given the term in section 201 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 321).
       ``(2) Institution of higher education.--The term 
     `institution of higher education' has the meaning given the 
     term in section 101(a) of the Higher Education Act of 1965 
     (20 U.S.C. 1001(a)).
       ``(3) Secretary.--The term `Secretary' means the Secretary 
     of Health and Human Services, acting through the Director of 
     the Centers for Disease Control and Prevention.

     ``SEC. 252. PUBLIC HEALTH SURVEILLANCE ENHANCEMENT.

       ``(a) In General.--The Secretary may--
       ``(1) make grants to, enter into cooperative agreements 
     with, and provide technical assistance to eligible agencies 
     to enable the agencies to enhance their capacity to carry out 
     activities relating to surveillance and prevention of 
     pathogen-related disease borne in a covered product, 
     particularly pathogen-related disease associated with 
     imported covered products, as described in subsection (b)(1); 
     and
       ``(2) carry out the activities described in subsection 
     (b)(2).
       ``(b) Use of Assistance.--
       ``(1) Agencies.--An eligible agency that receives 
     assistance under subsection (a) shall use the assistance to 
     enhance the capacity of the agency--
       ``(A) to identify, investigate, and contain threats of 
     pathogen-related disease borne in a covered product, 
     particularly pathogen-related disease associated with 
     imported covered products; and
       ``(B) to conduct additional surveillance and studies to 
     address prevention and control of the disease.
       ``(2) Centers for disease control and prevention.--The 
     Secretary may use not more than 30 percent of the funds 
     appropriated to carry out this section--
       ``(A) to assist an agency described in paragraph (1) in 
     enhancing the capacity described in paragraph (1) by 
     providing standards, technologies, information, materials, 
     and other resources; and
       ``(B) to enhance national surveillance systems, including 
     the ability of domestic and international agencies and 
     entities to respond to product safety issues associated with 
     imported covered products that are identified through such 
     systems.
       ``(c) Eligible Agencies.--To be eligible to receive 
     assistance under subsection (a)(1), an agency shall be a 
     State or local health department.
       ``(d) Application.--To be eligible to receive assistance 
     under subsection (a)(1), an agency shall submit an 
     application to the Secretary at such time, in such manner, 
     and containing such information as the Secretary may require.
       ``(e) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section such 
     sums as may be necessary for fiscal years 2001 through 2003.

     ``SEC. 253. PATHOGEN DETECTION RESEARCH AND DEVELOPMENT.

       ``(a) In General.--The Secretary may conduct applied 
     research, directly or by grant or contract, to develop new or 
     improved methods for detecting and subtyping emerging 
     pathogens (borne in covered products) in human specimens, 
     covered products, and relevant environmental samples. The 
     Secretary may use funds appropriated to carry out this 
     section to support applied research by State health 
     departments or institutions of higher education.
       ``(b) Application.--To be eligible to receive a grant or 
     enter into a contract under subsection (a), an entity shall 
     submit an application to the Secretary at such time, in such 
     manner, and containing such information as the Secretary may 
     require.
       ``(c) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section such 
     sums as may be necessary for fiscal years 2001 through 2003.

     ``SEC. 254. TRAINING, EDUCATION, AND PUBLIC INFORMATION.

       ``(a) In General.--The Secretary may--
       ``(1) make grants and enter into contracts with eligible 
     entities, to support training activities and other 
     collaborative activities with the entities to inform health 
     professionals about disease borne in covered products, 
     including strengthening training networks serving State, 
     local, and private entities; and
       ``(2) increase and improve the activities carried out by 
     the Centers for Disease Control and Prevention to provide 
     information to the public on disease borne in covered 
     products.
       ``(b) Eligible Entities.--To be eligible to receive a grant 
     or enter into a contract under subsection (a), an entity 
     shall be a medical school, a nursing school, an entity 
     carrying out clinical laboratory training programs, a school 
     of public health, another institution of higher education, a 
     professional organization, or an international organization.

[[Page S4689]]

       ``(c) Application.--To be eligible to receive a grant or 
     enter into a contract under subsection (a), an entity shall 
     submit an application to the Secretary at such time, in such 
     manner, and containing such information as the Secretary may 
     require.
       ``(d) Consultation.--In carrying out this section, the 
     Secretary shall consult with Federal, State, and local 
     agencies, international organizations, and other interested 
     parties.
       ``(e) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section such 
     sums as may be necessary for fiscal years 2001 through 2003.

     ``SEC. 255. INTERNATIONAL PUBLIC HEALTH TRAINING AND 
                   TECHNICAL ASSISTANCE.

       ``(a) In General.--The Secretary shall, directly or by 
     agreement, provide training and technical assistance to 
     agencies and entities in foreign countries, to strengthen the 
     surveillance and investigation capacities of the agencies and 
     entities relating to disease borne in covered products, 
     including establishing or expanding activities or programs 
     such as the Field Epidemiology and Training Program of the 
     Centers for Disease Control and Prevention.
       ``(b) Application.--To be eligible to enter into an 
     agreement under subsection (a), an entity shall submit an 
     application to the Secretary at such time, in such manner, 
     and containing such information as the Secretary may require.
       ``(c) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section such 
     sums as may be necessary for fiscal years 2001 through 2003.

     ``SEC. 256. SUPPLIES AND SERVICES IN LIEU OF GRANT FUNDS.

       ``(a) In General.--On the request of a recipient of 
     assistance under section 252, 253, 254, or 255, the Secretary 
     may, subject to subsection (b), provide supplies, equipment, 
     and services for the purpose of aiding the recipient in 
     carrying out the section involved and, for such purpose, may 
     detail to the grant recipient any officer or employee of the 
     Department of Health and Human Services. Such detail shall be 
     without interruption or loss of civil service status or 
     privilege.
       ``(b) Corresponding Reduction in Payments.--With respect to 
     a request described in subsection (a), the Secretary shall 
     reduce the amount of payments under the section involved by 
     an amount equal to the cost of detailing the officer or 
     employee and the fair market value of the supplies, 
     equipment, or services provided by the Secretary. The 
     Secretary shall, for the payment of expenses incurred in 
     complying with such a request, expend the amounts 
     withheld.''.
                                  ____


Summary of Imported Products Safety Improvement and Disease Prevention 
                              Act of 2000

                           TABLE OF CONTENTS


       Title I: Improvements to the Product Safety Import System

Title II: Enforcement and Penalties for Importing Contaminated Products

 Title III: Improvements to Public Health Infrastructure and Awareness

       Imported Products Safety Act of 2000--Title I: Improvements 
     to the Product Safety Import System--Amends the Federal Food, 
     Drug, and Cosmetic Act to require imported covered products 
     to be prepared, packed, and held under a system meeting the 
     requirements of such Act, or determined by the Secretary of 
     Health and Human Services (Secretary) to be equivalent to 
     domestic requirements. (``Covered product'' means a food as 
     defined under Section 201(f) of the Act and that is not a 
     dietary supplement.) Directs the Secretary to: (1) develop an 
     implementation plan; and (2) conduct overseas covered product 
     system evaluations.
       Directs the Secretary to establish, for use by the 
     Secretary of the Treasury, a system to deny the entry of 
     imported covered products from a specific area, producer, 
     manufacturer, or transporter into the United States that: (1) 
     has been repeatedly adulterated or associated with repeated 
     outbreaks of foodborne disease, presents a health danger, and 
     is likely without systematic changes to cause disease or be 
     adulterated again; or (2) in an emergency determination, has 
     been strongly associated with a serious outbreak of foodborne 
     disease.
       Makes a conforming amendment to the Public Health Service 
     Act.
       (Sec. 102) Deems as adulterated an imported (of offered for 
     import) covered product: (1) withheld for review that is 
     distributed prior to the Secretary's authorization of 
     distribution; (2) ordered to be held in secure storage prior 
     to distribution that is not so held; (3) required to be 
     destroyed that is not so destroyed; (4) previously denied 
     admission that is subsequently offered for admission without 
     a showing of appropriate compliance (port shopping); or (5) 
     owned or consigned by a debarred person.
       Authorizes the Secretary to: (1) prohibit distribution of 
     an imported covered product until the Secretary so 
     authorizes; (2) prohibit distribution and require the secure 
     storage of an imported covered product if the importer, 
     owner, or consignee of such product is a person against whom 
     the Secretary of the Treasury has assessed certain liquidated 
     damages for failure to redeliver covered products subject to 
     a bond; (3) order dangerous imported covered products to be 
     destroyed; and (4) require marking of refused entry (but not 
     ordered destroyed) covered product until brought into 
     appropriate compliance. Deems as misbranded a covered product 
     refused entry that is not so marked.
       (Sec. 108) Shortens the period before a refused entry 
     article which is not exported shall be destroyed.
       (Sec. 109) Authorizes the Secretary to provide for the 
     collection and analysis of imported covered products by 
     entities other than the Food and Drug Administration.
       Title II: Enforcement and Penalties for Importing 
     Contaminated Food--Amends the Federal Food, Drug, and 
     Cosmetic Act to establish bonding requirements for persons 
     involved in prior importing of adulterated or misbranded 
     covered products.
       (Sec. 202) Authorizes the Secretary to debar a person from 
     importing covered products into the United States for covered 
     product import-related repeat or felony activities.
       (Sec. 203) Authorizes appropriations for additional Food 
     and Drug Administration laboratory, inspection, and 
     compliance personnel.
       Title III: Improvements to Public Health Infrastructure and 
     Awareness--Amends the Public Health Service Act to authorize 
     the Secretary, through the Centers for Disease Control and 
     Prevention, to make grants to, enter into contracts with, and 
     provide technical assistance to State and local health 
     entities for enhanced surveillance and prevention of 
     foodborne disease, particularly related to imported covered 
     products. Authorizes appropriations.
       Authorizes the Secretary, with respect to foodborne 
     disease, to: (1) conduct pathogen detection research and 
     development; and (2) provide for training, education, and 
     public information. Authorizes appropriations.
       Directs the Secretary to provide related international 
     public health training and technical assistance. Authorizes 
     appropriations.

  Mr. KENNEDY. I am reintroducing this important bill because of the 
seriousness of the problem it addresses and to spur this Congress to 
take action. I commend Senator Mikulski for her continued leadership on 
this legislation to close the critical gaps in our imported food safety 
laws.
  Citizens deserve to know that the foods they eat are safe and 
wholesome, regardless of their source. The United States has one of the 
safest food supplies in the world. Yet, every year, millions of 
Americans become sick, and thousands die, from eating contaminated 
food. Food-borne illnesses cause billions of dollars a year in medical 
costs and lost productivity. Often, the source of the problem is 
imported food.
  The number of reports in the press of illnesses caused by eating 
contaminated imported foods has grown steadily over the past few years.
  For example, in 1997, school children in five states contracted 
Hepatitis A from frozen strawberries served in the school cafeterias. 
Fecal contamination is a potential source of Hepatitis A, and the 
strawberries the children ate came from a farm in Mexico where workers 
had little access to sanitary facilities.
  Earlier this year, cases of typhoid fever in Florida were linked to a 
frozen tropical fruit product from Guatemala. Again, poor sanitary 
conditions appear to be at the root of the problem.
  Gastrointestinal illness has been linked to soft cheeses from Europe. 
Bacterial food poisoning has been attributed to canned mushrooms from 
the Far East.
  The emergence of highly virulent strains of bacteria, and an increase 
in the number of organisms that are resistant to antibiotics, make 
microbial contamination of food a major public health challenge.
  Ensuring the safety of imported food is a huge task. Americans now 
enjoy a wide variety of foods from around the world and have access to 
fresh fruits and vegetables year round. In 1997, the Food Safety 
Inspection Service of the Department of Agriculture handled 118,000 
entries of imported meat and poultry. The FDA handled far more--2.7 
million entries of other imported food. Current FDA procedures and 
resources allowed for less than two percent of those 2.7 million 
imports to be physically inspected. Clearly, we need to do better.
  The FDA lacks sufficient authority to prevent contaminated food 
imports from reaching our shores. The agency has no legal authority to 
require that food imported into the United States has been prepared, 
packed and stored under conditions that provide the same level of 
public health protection as similar food produced in the United States. 
Under current procedures, the FDA takes random samples of imports as 
they arrive at the border. The imports often continue on their way to 
stores in all parts of the country while testing is being done, and it 
is often

[[Page S4690]]

difficult to recall the food if a problem is found. Unscrupulous 
importers make the most of the loopholes in the law, including 
substituting cargo, falsifying laboratory results, and attempting to 
bring a refused shipment in again, at a later date or at a different 
port.
  The legislation we are reintroducing today will give the Secretary of 
Health and Human Services the additional authority needed to assure 
that food imports are as safe as food grown and prepared in this 
country.
  It will give the FDA greater authority to deal with outbreaks of 
food-borne illness and to bar further imports of dangerous foods until 
improvements at the source can guarantee the safety of future 
shipments. This authority covers foods that have repeatedly been 
associated with food-borne disease, have repeatedly been found to be 
adulterated, or have been linked to a catastrophic outbreak of food-
borne illness.
  The legislation will also close loopholes in the law and give the FDA 
better tools to deal with unscrupulous importers.
  In addition, the legislation will authorize the Centers for Disease 
Control and Prevention to target resources toward enhanced surveillance 
and prevention activities to deal with food-borne illnesses, including 
new diagnostic tests, better training of health professionals, and 
increased public awareness about food safety.
  Too many citizens today are at unnecessary risk of food-borne 
illness. The measure we are proposing is designed to reduce that risk 
as much as possible, both immediately and for the long term. We know 
that there are powerful special interests that put profits ahead of 
safety. But Americans need and deserve laws that better protect their 
food supply. This is essential legislation, and I look forward to 
working with my colleagues to see that it is enacted as soon as 
possible.

                          ____________________